Justia Department Of Health And Human Services Centers For Medicare & Medicaid Services Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2019; Medicare Shared Savings Program Requirements; Quality Payment Program; Medicaid Promoting Interoperability Program; Quality Payment Program Extreme and Uncontrollable Circumstance Policy for the 2019 MIPS Payment Year; Provisions From the Medicare Shared Savings Program Accountable Care OrganizationsPathways to Success; and Expanding the Use of Telehealth Services for the Treatment of Opioid Use Disorder Under the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, 59836-60303 [2018-24170]

Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2019; Medicare Shared Savings Program Requirements; Quality Payment Program; Medicaid Promoting Interoperability Program; Quality Payment Program Extreme and Uncontrollable Circumstance Policy for the 2019 MIPS Payment Year; Provisions From the Medicare Shared Savings Program Accountable Care OrganizationsPathways to Success; and Expanding the Use of Telehealth Services for the Treatment of Opioid Use Disorder Under the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, 59836-60303 [2018-24170]

Download as PDF amozie on DSK3GDR082PROD with RULES3 59836 VerDate Sep<11>2014 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 E:\FR\FM\23NOR3.SGM 23NOR3 59837 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations TABLE 47: MIPS APM Measure List--Bundled Payments for Care Improvement Advanced Model Advanced Care Plan Perioperative Care: Selection of Prophylactic Antibiotic: First or Second Generation Cephalosporin Hospital30-day, All-Cause, RiskStandardized Mortality Rate (RSMR) Following Elective Coronary Artery Bypass Graft (CABG) Surgery amozie on DSK3GDR082PROD with RULES3 Excess Days in Acute Care After Hospitalization for Acute Myocardial Infarction VerDate Sep<11>2014 National Quality Strategy Domain Communication and Care Coordination 0326 (adapted) Communication and Care Coordination 1 0268 Patient Safety 2558 Patient Safety 2881 Patient Safety 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00003 Fmt 4701 Measure Description This measure estimates a hospital-level riskstandardized readmission rate (RSRR) of unplanned, all cause readmission after admission for any eligible condition within 30 days of hospital discharge. Percentage of patients aged 65 years and older who have an advance care plan or surrogate decision maker documented in the medical record or documentation in the medical record that an advance care plan was discussed but the patient did not wish or was not able to name a surrogate decision maker or provide an advance care plan. Percentage of surgical patients aged 18 years and older undergoing procedures with the indications for a first OR second generation cephalosporin prophylactic antibiotic who had an order for first OR second generation cephalosporin for antimicrobial prophylaxis. The measure estimates a hospital-level, riskstandardized mortality rate (RSMR) for patients 18 years and older discharged from the hospital following a qualifying isolated CABG procedure. Mortality is defmed as death from any cause within 30 days of the procedure date of an index CABG admission. The measure was developed using Medicare Fee-for-Service (FFS) patients 65 years and older and was tested in all-payer patients 18 years and older. An index admission is the hospitalization for a qualifying isolated CABG procedure considered for the mortality outcome. This measure assesses days spent in acute care within 30 days of discharge from an inpatient hospitalization for acute myocardial infarction (AMI) to provide a patient-centered assessment of the post-discharge period. This measure is intended to capture the quality of care transitions provided to discharged patients hospitalized with AMI by collectively measuring a set of adverse acute care outcomes that can occur postdischarge: emergency department (ED) visits, observation stays, and unplanned readmissions at any time during the 30 days post-discharge. To aggregate all three events, we measure each in terms of days. In 2016, CMS will begin annual reporting of the measure for patients who are 65 years or older, are emolled in fee-forservice (FFS) Medicare, and are hospitalized in Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 Primary Measure Steward CMS NCQA American Society of Plastic Surgeons CMS CMS ER23NO18.061</GPH> Measure Name All-Cause Hospital Readmission NQF/ Quality ID # 1789 59838 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations NQF/ Quality ID # Primary Measure Steward National Quality Strategy Domain amozie on DSK3GDR082PROD with RULES3 VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00004 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.062</GPH> Measure Description non-federal hospitals. The modified PSI-90 Composite measure (name AHRQ 0531 Patient Safety AHRQ Patient Safety Measures changed to Patient Safety and Adverse Events Composite) consists of ten component indicators: PSI-3 Pressure ulcer rate; PSI-6 Iatrogenic pneumothorax rate; PSI-8 Postoperative hip fracture rate; PSI-09 Perioperative hemorrage or hematoma rate; PSI10 hysiologic and metabolic derangement rate; PSI-11 postoperative respiratory failure rate; PSI-12 Perioperative puhnonary embolism or Deep vein thrombosis rate; PSI-13 Postoperative sepsis rate; PSI-14 Postoperative wound dehiscence rate; and PSI-15 Accidental puncture or laceration rate. Hospital-Level 1550 Patient Safety The measure estimates a hospital-level riskCMS Risk-Standardized standardized complication rate (RSCR) Complication Rate associated with elective primary THA and TKA Following Elective in Medicare Fee-For-Service beneficiaries who Primary Total Hip are 65 years and older. The outcome (complication) is defmed as any one of the Arthroplasty and/or Total Knee specified complications occurring from the date of index admission to 90 days post date ofthe Arthroplasty index admission (the admission included in the measure cohort). 1 The specificatiOns used for the Advanced Care Plan quahty measure m BPCI Advanced are not NQF endorsed, but have been created specifically for BPCI Advanced. Measure Name Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 59839 TABLE 48: MIPS APM Measure List-Maryland Total Cost of Care Model (Maryland Primary Care Program) Controlling High Blood Pressure 0018 Effective I Clinical Care Diabetes: Hemoglobin Ale (HbA 1c) Poor Control (>9 percent) Initiation and Engagement of Alcohol and Other Drug Dependence Treatment 0059 Effective Clinical Care Percentage of patients 18-85 years of age who had a diagnosis of hypertension and whose blood pressure was adequately controlled (<140190 mmHg) during the measurement period. Percentage of patients 18-75 years of age with diabetes who had hemoglobin Ale> 9.0 percent during the measurement period. 0004 Effective I Clinical Care Not Endorsed Person and Family Engagement/ Patient and Caregiver Experience Not Endorsed Communication and Care Coordination Not Endorsed Communication and Care Coordination CG-CAHPS Survey 3.0modified for CPC+ Inpatient Hospital Utilization amozie on DSK3GDR082PROD with RULES3 Emergency Department Utilization VerDate Sep<11>2014 NQFI Quality 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00005 Fmt 4701 Primary Measure Steward National Committee for Quality Assurance National Committee for Quality Assurance Percentage of patients 13 years of age and older with a new episode of alcohol and other drug (AOD) dependence who received the following. Two rates are reported: a. Percentage of patients who initiated treatment within 14 days of the diagnosis. b. Percentage of patients who initiated treatment and who had two or more additional services with an AOD diagnosis within 30 days of the initiation visit. CG--CAHPS Survey 3.0 National Committee for Quality Assurance For members 18 years of age and older, the risk-adjusted ratio of observed to expected acute inpatient discharges during the measurement year reported by Surgery, Medicine, and Total. For members 18 years of age and older, the risk-adjusted ratio of observed to expected emergency department (ED) visits during the measurement year. National Committee for Quality Assurance Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 AHRQ National Committee for Quality Assurance ER23NO18.063</GPH> National Quality Strategy Domain Measure Description ID Measure Name Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations amozie on DSK3GDR082PROD with RULES3 BILLING CODE 4120–01–C We proposed to update the MIPS APM measure sets that apply for purposes of the APM scoring standard (83 FR 35933 through 35934). The following is a summary of the public comments received on these measure sets and our responses: Comment: Several commenters supported the measure sets set forth in the proposed rule. Other commenters recommended additional measures to be used in future years or suggested modifications to the measures themselves. Response: We thank the commenters for their support and note that, consistent with § 414.1370(g)(1)(i)(A) and (ii)(A), we are using only measures that are included or that CMS intends to include in each APM measures set at the time of publication of this final rule. Should those measures be removed or revised from that measure set before the end of the performance year, we will not score APM Entities on their performance on those measures, but will VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 include updated measures in future rulemaking. Per our policy expressed in last year’s final rule (82 FR 53695 and 53696), the measure sets on the MIPS APM measure list for the year will represent all possible measures which may contribute to an APM Entity’s MIPS score for the MIPS quality performance category, and may include measures that are the same as or similar to those used by MIPS. However, a given measure ultimately might not be used for scoring, for example if its data becomes inappropriate or unavailable for scoring. After consideration of the comments received, we are finalizing our proposal to update the MIPS APM measure sets that apply for purposes of the APM scoring standard and will score only measures that already have been included in the measure sets of their given APM, according to the terms of participation in that APM. We note that Table 48 has been updated to reflect the most current APM measure sets. PO 00000 Frm 00006 Fmt 4701 Sfmt 4700 i. MIPS Final Score Methodology (1) Converting Measures and Activities Into Performance Category Scores (a) Background For the 2021 MIPS payment year, we intend to build on the scoring methodology we finalized for the transition years, which allows for accountability and alignment across the performance categories and minimizes burden on MIPS eligible clinicians. The rationale for our scoring methodology continues to be grounded in the understanding that the MIPS scoring system has many components and various moving parts. As we continue to move forward in implementing the MIPS program, we strive to balance the statutory requirements and programmatic goals with the ease of use, stability, and meaningfulness for MIPS eligible clinicians. We do so while also emphasizing simplicity and the continued development of a scoring methodology that is understandable for MIPS eligible clinicians. E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.064</GPH> 59840 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations In the CY 2017 Quality Payment Program final rule, we finalized a unified scoring system to determine a final score across the 4 performance categories (81 FR 77273 through 77276). For the 2019 MIPS performance period, we proposed to build on the scoring methodology we previously finalized, focusing on encouraging MIPS eligible clinicians to meet data completeness requirements (83 FR 35948 through 35949). For quality performance category scoring, we proposed to extend some of the transition year policies to the 2019 MIPS performance period, and we also proposed several modifications to existing policies (83 FR 35947 through 35949). In the CY 2018 Quality Payment Program final rule (82 FR 53712 through 53714), we established a methodology for scoring improvement in the cost performance category. However, as required by section 51003(a)(1)(B) of the Bipartisan Budget Act of 2018, we proposed that the cost performance category score would not take into account improvement until the 2024 MIPS payment year (83 FR 35956). In the CY 2018 Quality Payment Program final rule (82 FR 53753 through 53767), we finalized the availability of a facility-based measurement option for clinicians who met certain requirements, beginning with the 2019 MIPS performance period. As discussed in section III.I.3.i.(1)(d) of this final rule, we are finalizing our proposal to change the determination of facility-based measurement to include consideration of presence in the on-campus outpatient hospital. The policies for scoring the 4 performance categories are described in detail in section III.I.3.i.(1) of this final rule. These policies will help eligible clinicians as they participate in the 2019 MIPS performance period/2021 MIPS payment year, and as we move beyond the transition years of the program. Section 51003 of the Bipartisan Budget Act of 2018 provides flexibility to continue the gradual ramp up of the Quality Payment Program and enables us to extend some of the transition year policies to the 2019 performance period. Unless otherwise noted, for purposes of this section III.I.3.i. of this final rule, the term ‘‘MIPS eligible clinician’’ will refer to MIPS eligible clinicians who collect and submit data and are scored at either the individual or group level, including virtual groups; it will not refer to MIPS eligible clinicians who are scored by facility-based measurement, as discussed in section III.I.3.i.(1)(d) of this final rule. We also note that the APM scoring standard applies to MIPS eligible clinicians in APM Entities in MIPS APMs, and those policies take VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 precedence where applicable. Where those policies do not apply, scoring for MIPS eligible clinicians as described in section III.I.3.h.(6) of this final rule will apply. We refer readers to section III.I.4. of this final rule for additional information about the APM scoring standard. (b) Scoring the Quality Performance Category for the Following Collection Types: Part B Claims Measures, eCQMs, MIPS CQMs, QCDR Measures, CMS Web Interface Measures, the CAHPS for MIPS Survey Measure and Administrative Claims Measures Although we did not propose changing the basic scoring system that we finalized in the CY 2018 Quality Payment Program final rule for the 2021 MIPS payment year (82 FR 53712 through 53748), we proposed several modifications to scoring the quality performance category, including removing high-priority measure bonus points for CMS Web Interface measures and extending the bonus point caps, and adding a small practice bonus to the quality performance category score. The following section describes these previously finalized policies and our proposals (83 FR 35950 through 35952). We also proposed updates to § 414.1380(b)(1) in an effort to more clearly and concisely capture previously established policies (83 FR 35946 through 35955). These proposed updates are not intended to be substantive in nature, but rather to bring more clarity to the regulatory text. We will make note of the updated regulatory citations in their relevant sections below. (i) Scoring Terminology In the CY 2017 and CY 2018 Quality Payment Program final rules (81 FR 77008 through 77831 and 82 FR 53568 through 54229, respectively), we used the term ‘‘submission mechanisms’’ in reference to the various ways in which a MIPS eligible clinician or group can submit data to CMS. As discussed in section III.I.3.h.(1)(b) of this final rule, it has come to our attention that the way we have described the various ways in which MIPS eligible clinicians, groups and third-party intermediaries can submit data to our systems does not accurately reflect the experience users have when submitting data to us. We refer readers to section III.I.3.h.(1)(b) of this final rule for further discussion on our finalized changes to the scoring terminology related to measure specification and data collection and submission. For additional discussion on the impact of the proposed terminology change on our PO 00000 Frm 00007 Fmt 4701 Sfmt 4700 59841 benchmarking methodology, validation process, and end-to-end reporting bonus, we refer readers to sections III.I.3.i.(1)(b)(ii), (v), and (x) of this final rule. (ii) Quality Measure Benchmarks We refer readers to the CY 2017 and CY 2018 Quality Payment Program final rules (81 FR 77282 and 82 FR 53718, respectively) for our previously established benchmarking policies. As part of our proposed technical updates to § 414.1380(b)(1) discussed in section III.I.3.i.(1)(a)(i) of this final rule, our previously established benchmarking policies at § 414.1380(b)(1)(i) through (iii) would now be referenced at § 414.1380(b)(1)(i) through (ii). When we developed the quality measure benchmarks, we sought to develop a system that enables MIPS eligible clinicians, beneficiaries, and other stakeholders to understand what is required for a strong performance in MIPS while being consistent with statutory requirements (81 FR 28249 through 28250). The feedback we have received thus far from stakeholders on our benchmarks is helping to inform our approach to the benchmarking methodology, especially as we look for possible ways of aligning with Physician Compare benchmarks. As described in section III.I.3.i.(1)(b)(xii) of this final rule, we solicited comment on potential future approaches to scoring the quality performance category to continue to promote value and improved outcomes. We anticipate changes in scoring would be paired with potential modifications to measure selection and criteria discussed in section III.I.3.h.(2)(b) of this final rule. In the CY 2019 PFS proposed rule (83 FR 35947), we sought input on opportunities to further reduce confusion about our benchmarking methodology described in the CY 2017 Quality Payment Program final rule (81 FR 77277 through 77278), which includes further clarification of our benchmarking process and potential areas of alignment between the MIPS and Physician Compare benchmarking methodologies. We thank commenters for their input and may take this input into consideration in future years. (A) Revised Terminology for MIPS Benchmarks We previously established at § 414.1380(b)(1)(iii) separate benchmarks for the following submission mechanisms: EHR; QCDR/ registry, claims; CMS Web Interface; CMS-approved survey vendor; and administrative claims. In the CY 2019 E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59842 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations PFS proposed rule, we did not propose to change our basic approach to our benchmarking methodology; however, we proposed to amend § 414.1380(b)(1)(ii) consistent with the proposed data submission terminology changes discussed in section III.I.3.h.(1)(b) of this final rule (83 FR 35947). Specifically, beginning with the 2021 MIPS payment year, we proposed to establish separate benchmarks for the following collection types: eCQMs; QCDR measures (as described at § 414.1400(e)); MIPS CQMs; Medicare Part B claims measures; CMS Web Interface measures; the CAHPS for MIPS survey; and administrative claims measures. We would apply benchmarks based on collection type rather than submission mechanism. For example, for an eCQM, we would apply the eCQM benchmark regardless of submitter type (MIPS eligible clinician, group, third party intermediary). In addition, we would establish separate benchmarks for QCDR measures and MIPS CQMs since these measures do not have comparable specifications. In addition, we note that our proposed benchmarking policy allows for the addition of future collection types as the universe of measures continues to evolve and as new technology is introduced. Specifically, we proposed to amend § 414.1380(b)(1)(ii) to remove the mention of each individual benchmark and instead state that benchmarks will be based on collection type, from all available sources, including MIPS eligible clinicians and APMs, to the extent feasible, during the applicable baseline or performance period. The following is a summary of the public comments on these proposals and our responses: Comment: A few commenters expressed support for our proposal to establish separate benchmarks by collection types, citing the difference in measure performance across collection types. One commenter stated this update would maintain consistency when migrating between current MIPS terminology to proposed MIPS terminology. Response: We thank commenters for their support as we continue to clarify and improve our benchmarking policies. Comment: One commenter expressed concern about the proposal to update our regulatory text to state that benchmarks are based on collection types from all available sources, including APMs. Specifically, the commenter noted that incorporating APM data into benchmark calculations will set the benchmarks too high since APM participants tend to be high performers. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 Response: We recognize commenter’s concern; however, this is not a new policy, and we refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77279) for additional discussion on the inclusion of APMs in the MIPS benchmarks. As measures and technology evolve, we are constantly reviewing and evaluating what data sources are appropriate for benchmarks. Comment: One commenter requested clarification on whether QCDR measures that have an e-specified collection type and a manual collection type will also be considered separate collection types with distinct benchmarks. Response: We expect that a QCDR measure for which data is abstracted through EHRs or manually (that is, paper records) would have to be approved as two separate measures. As a result, each measure would only be compared to its own benchmark. After consideration of public comments, we are finalizing our proposal, beginning with the 2021 MIPS payment year, to amend § 414.1380(b)(1)(ii) to establish separate benchmarks based on collection type and to remove the mention of each individual benchmark and state that benchmarks will be based on collection type, from all available sources, including MIPS eligible clinicians and APMs, to the extent feasible, during the applicable baseline or performance period. FR 53719). For measures with benchmarks based on the baseline period, we stated that the 3-point floor was for the transition year and that we would revisit the 3-point floor in future years (81 FR 77286 through 77287; 82 FR 53719). For the 2021 MIPS payment year, we proposed to again apply a 3-point floor for each measure that can be reliably scored against a benchmark based on the baseline period, and to amend § 414.1380(b)(1)(i) accordingly (83 FR 35947). We will revisit the 3-point floor for such measures again in future rulemaking. We requested comments on the proposal above. These comments and our responses are discussed below. Comment: Several commenters expressed support for the three-point floor for measures that can be reliably scored against a benchmark based on the baseline period because it would reduce confusion, help reduce burden, maintain stability, and encourage physicians to continue to participate in MIPS. Response: We thank commenters for their support. After consideration of public comments, we are finalizing our proposal, for the 2021 MIPS payment year, to apply a 3-point floor for each measure that can be reliably scored against a benchmark, and to amend § 414.1380(b)(1)(i) accordingly. (iii) Assigning Points Based on Achievement In the CY 2017 Quality Payment Program final rule, we established the policies for scoring quality measures performance (81 FR 77286). We refer readers to § 414.1380(b)(1) for more on these policies. (B) Additional Policies for the CAHPS for MIPS Measure Score (A) Floor for Scored Quality Measures For the 2019 and 2020 MIPS payment years, we finalized at § 414.1380(b)(1)(i) a global 3-point floor for each scored quality measure, as well as for the hospital readmission measure (if applicable). In this way, MIPS eligible clinicians would receive between 3 and 10 measure achievement points for each submitted measure that can be reliably scored against a benchmark, which requires meeting the case minimum and data completeness requirements (81 FR 77286 through 77287; 82 FR 53719). For measures with a benchmark based on the performance period (rather than on the baseline period), we stated that we would continue to assign between 3 and 10 measure achievement points for performance periods after the first transition year (81 FR 77282, 77287; 82 PO 00000 Frm 00008 Fmt 4701 Sfmt 4700 Although participating in the CAHPS for MIPS survey is optional for all groups, some groups will be unable to participate in the CAHPS for MIPS survey because they do not meet the minimum beneficiary sampling requirements. CMS has sampling requirements for groups of 100 or more eligible clinicians, 25 to 99 eligible clinicians, and 2 to 24 eligible clinicians to ensure an adequate number of survey responses and the ability to reliably report data. Our sampling timeframes necessitate notifying groups of their inability to meet the sampling requirements late in the performance period (see 82 FR 53630 through 53632). As a result, we are concerned that some groups that expect and plan to meet the quality performance category requirements using the CAHPS for MIPS survey may find out late in the performance period that they are unable to meet the sampling requirements and, therefore, are unable to have their performance assessed on this measure. These groups may need to report on another measure to meet the E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations requirements of the quality performance category. We want to encourage the reporting of the CAHPS for MIPS survey and do not want the uncertainty regarding sampling requirements to be a barrier to selecting the CAHPS for MIPS survey. To mitigate this concern, beginning with the 2021 MIPS payment year, we proposed to reduce the denominator (that is, the total available measure achievement points) for the quality performance category by 10 points for groups that register for the CAHPS for MIPS survey but do not meet the minimum beneficiary sampling requirements (83 FR 35948). By reducing the denominator instead of only assigning the group a score of zero measure achievement points (because the group would be unable to submit any CAHPS for MIPS survey data), we are effectively removing the impact of the group’s inability to submit the CAHPS for MIPS survey. We believe this reduction in denominator would remove any need for groups to find another measure if they are unable to submit the CAHPS for MIPS survey. Therefore, we proposed to amend § 414.1380 to add paragraph (b)(1)(vii)(B) to state that we will reduce the total available measure achievement points for the quality performance category by 10 points for groups that registered for the CAHPS for MIPS survey but do not meet the minimum beneficiary sampling requirements. We requested comments on the proposal above. These comments and our responses are discussed below. Comment: Several commenters supported our proposed policy. One commenter believes this will encourage more groups to conduct the survey. Response: We appreciate the commenters’ support. Comment: One commenter requested clarification on when groups would be notified that they did not meet the beneficiary sampling requirement. The commenter also requested clarification on what protections the agency will institute for groups who must cancel their contracts with survey vendors ‘‘late in the performance period’’ when they are notified that they did not meet the beneficiary sampling requirement. The commenter stated that CMS should not hold groups accountable for vendor costs that result from the agency’s late notification process. Response: We do not anticipate the notification process for minimum beneficiary sample requirements will change. CMS provides information on sample design and sample size requirements in the QPP Resource Library to aid groups in deciding whether or not to elect CAHPS for VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 MIPS. CMS sends communication about sample size eligibility to the point of contact provided by each group during the registration process for CAHPS for MIPS. Providing more than one point of contact will help to promote timely delivery of the information on sample size eligibility to the group. Groups should coordinate with their vendors to address any questions regarding costs in the event the group does not meet the beneficiary sampling requirement. For any additional questions please visit the Quality Payment Program website at qpp.cms.gov. Comment: One commenter sought clarification whether CMS would automatically apply the scoring policy or first provide groups with the option to report on an alternate quality measure or improvement activity. Response: We will not automatically apply the scoring policy. Notifications will be sent twice to groups that have registered for the CAHPS for MIPS survey and who have an insufficient sample size, with the second notification usually occurring in September. These notifications also encourage groups to select other relevant measures that can be completed. We believe that this policy is necessary because the notification late in the performance period might not allow sufficient time for groups to collect and report a different quality measure, however, some practices may have other quality measures (beyond the 6 minimum) that they have been reporting on that could be submitted within the performance period. For groups that submitted 5 or fewer quality measures and do not meet the CAHPS for MIPS sampling requirements, the quality denominator will be reduced by 10 points. For groups that submitted 6 or more quality measures and do not meet the CAHPS for MIPS sampling requirements, we will score the 6 measures with the highest achievement points. The notification will also encourage groups to select other relevant improvement activities that can be completed within the performance period. We refer readers to section III.I.3.h.(4)(b) of this final rule for further information on submission criteria for the improvement activities performance category. After consideration of public comments, we are finalizing our proposal to amend § 414.1380 to add paragraph (b)(1)(vii)(B) to state that we will reduce the total available measure achievement points for the quality performance category by 10 points for groups that submit 5 or fewer quality measures and register for the CAHPS for PO 00000 Frm 00009 Fmt 4701 Sfmt 4700 59843 MIPS survey, but do not meet the minimum beneficiary sampling requirements. We do not want groups to register for the CAHPS for MIPS survey if they know in advance that they are unlikely to be able to meet the sampling requirement, so we solicited comments on whether we should limit this proposed policy to groups for only one MIPS performance period. For example, for the performance period following the application of this proposed policy, a notice could be provided to groups during registration indicating that if the sampling requirement is not met for a second consecutive performance period, the proposed policy will not be applied. This would provide notice to the group that they may not meet the sampling requirement needed for the CAHPS for MIPS survey and may need to look for alternate measures but does not preclude the group from registering for the CAHPS for MIPS survey if they expect to meet the minimum beneficiary sampling requirements in the second MIPS performance period. We thank commenters for their suggestions and may consider them for future rulemaking. (iv) Assigning Measure Achievement Points for Topped Out Measures We refer readers to CY 2017 Quality Payment Program final rule (82 FR 53721 through 53727) for our established policies for scoring topped out measures. Under § 414.1380(b)(1)(xiii)(A), for the 2020 MIPS payment year, 6 measures will receive a maximum of 7 measure achievement points, provided that the applicable measure benchmarks are identified as topped out again in the benchmarks published for the 2018 MIPS performance period. Under § 414.1380(b)(1)(xiii)(B), beginning with the 2021 MIPS payment year, measure benchmarks (except for measures in the CMS Web Interface) that are identified as topped out for 2 or more consecutive years will receive a maximum of 7 measure achievement points beginning in the second year the measure is identified as topped out (82 FR 53726 through 53727). As part of our technical updates to § 414.1380(b)(1) outlined in section III.I.3.i.(1)(b) of this final rule, our previously finalized topped out scoring policies are now referenced at § 414.1380(b)(1)(iv). We refer readers to the 2018 MIPS Quality Benchmarks’ file that is located on the Quality Payment Program resource library (https://www.cms.gov/ Medicare/Quality-Payment-Program/ Resource-Library/Resource-library.html) to determine which measure E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations benchmarks are topped out for 2018 and would be subject to the cap if they are also topped out in the 2019 MIPS Quality Benchmarks’ file. We note that the final determination of which measure benchmarks are subject to the topped out cap will not be available until the 2019 MIPS Quality Benchmarks’ file is released in late 2018. We did not propose to apply our previously finalized topped out scoring policy to the CAHPS for MIPS survey (82 FR 53726). Because the CAHPS for MIPS survey was revised in 2018 (82 FR 53632), we do not have historical benchmarks for the 2018 performance period, so the topped out policy would not be applied for the 2019 performance period. Last year, we received limited feedback when we sought comment on how the topped out scoring policy should be applied to CAHPS for MIPS survey. In CY 2019 PFS proposed rule, we sought feedback on potential ways we can score CAHPS for MIPS Summary Survey Measures (SSM) (83 FR 35948). For example, we could score all SSMs, which means there would effectively be no topped out scoring for CAHPS for MIPS SSMs, or we could cap the SSMs that are topped out and score all other SSMs. We sought comment on these approaches and additional approaches to the topped out scoring policy for CAHPS for MIPS SSMs. We noted that we encourage groups to report the CAHPS for MIPS survey as it incorporates beneficiary feedback. We thank commenters for their suggestions and will consider them for future rulemaking. As the MIPS program continues to mature, we are looking to find ways to improve our policies, including what to do with measures that do not meet the case minimum. Although many MIPS eligible clinicians can meet the 20-case minimum requirement, we recognize that small practices and individual MIPS eligible clinicians may have difficulty meeting this standard. Although we process data from the CY 2017 MIPS performance period to VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 (v) Scoring Measures That Do Not Meet Case Minimum, Data Completeness, and Benchmarks Requirements In the CY 2017 Quality Payment Program final rule (81 FR 77288 through PO 00000 Frm 00010 Fmt 4701 Sfmt 4700 77289), we established scoring policies for a measure that is submitted but is unable to be scored because it does not meet the required case minimum, does not have a benchmark, or does not meet the data completeness requirement. As part of our technical updates to § 414.1380(b)(1) discussed in section III.I.3.i.(1)(b) of this final rule, our previously finalized scoring policies are now referenced at § 414.1380(b)(1)(i)(A) and (B). A summary of the current and proposed policies is provided in Table 50. For more of the statutory background and details on current policies, we refer readers to the CY 2017 and CY 2018 Quality Payment Program final rules (81 FR 77288 through 77289 and 82 FR 53727 through 53730, respectively). determine how often submitted measures do not meet case minimums, we invited public comment on ways we can improve our case-minimum policy. In determining future improvements to our case minimum policy, our goal is to E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.065</GPH> amozie on DSK3GDR082PROD with RULES3 59844 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations balance the concerns of MIPS eligible clinicians who are unable to meet the case minimum requirement and for whom we cannot capture enough data to reliably measure performance, while not creating incentives for MIPS eligible clinicians to choose measures that do not meet case minimum even though other more relevant measures are available. We thank commenters for their suggestions and will consider them for future rulemaking. In the CY 2019 PFS proposed rule (83 FR 35949), we proposed to maintain the policies finalized for the CY 2018 MIPS performance period regarding measures that do not meet the case-minimum requirement, do not have a benchmark, or do not meet the data-completeness criteria for the CY 2019 MIPS performance period, and to amend § 414.1380(b)(1)(i) accordingly. We also proposed to assign zero points for measures that do not meet data completeness starting with the CY 2020 MIPS performance period and to amend § 414.1380(b)(1)(i)(B)(1) accordingly (83 FR 35949). This policy is part of our effort to move toward complete and accurate reporting that reflects meaningful effort to improve the quality of care that patients receive. Measures submitted by small practices would continue to receive 3 points for all future CY MIPS performance periods, although we may revisit this policy through future rulemaking. We requested comments on the proposals above. These comments and our responses are discussed below. Comment: Several commenters supported the proposal to maintain the policies finalized for the CY 2018 MIPS performance period regarding measures that do not meet the case minimum requirement, do not have a benchmark, or do not meet the data-completeness criteria for the CY 2019 MIPS performance period. Response: We thank commenters for their support. However, we want to stress that these policies were not meant to be permanent and as clinicians continue to gain experience with the program we will revisit the appropriateness of these policies in future rulemaking. Comment: A few commenters did not support our proposal to reduce points for measures that do not meet data completeness to zero starting with the CY 2020 MIPS performance period because of concerns that it would add complexity and burden as clinicians are continuing to learn the program. A few commenters suggested that CMS should return to assigning these measures 3 points or, at a minimum, continue to VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 assign them 1 point or provide special scoring for MIPS eligible clinicians with significant administrative burdens. A few commenters recommended that clinicians should at least get some credit for attempting to report and, through no fault of their own, fail to meet the data completeness threshold, citing the difficulty of getting all the necessary data from hospitals and/or their billing companies to report on 60 percent of all applicable patients. Response: We understand and recognize commenters’ concerns. However, as the program is being fully implemented, we want to ensure that our policies align with our goal of improving quality. This scoring policy was intended to be temporary, and we believe that data completeness is something that is within the direct control of clinicians. Although we understand that many clinicians have administrative burdens and we continuously strive to reduce paperwork, we also believe that it is important to develop policies that align with the program’s goal to improve quality of care. By the fourth year of implementation, we believe this policy is no longer needed and that removing this policy helps streamline our scoring policies. After consideration of public comments, we are finalizing the proposal to maintain the policies finalized for the CY 2018 MIPS performance period regarding measures that do not meet the case-minimum requirement, do not have a benchmark, or do not meet the data-completeness criteria for the CY 2019 MIPS performance period, and the amending of § 414.1380(b)(1)(i) accordingly. After consideration of public comments, we are finalizing our proposal to assign zero points for measures that do not meet data completeness starting with the CY 2020 MIPS performance period and to amend § 414.1380(b)(1)(i)(B)(1) accordingly. Measures submitted by small practices will continue to receive 3 points for all future MIPS performance periods. (vi) Scoring Flexibility for Measures With Clinical Guideline Changes During the Performance Period In the CY 2018 Quality Payment Program final rule (82 FR 53714 through 53716), we finalized that, beginning with the 2018 MIPS performance period, we will assess performance on measures considered significantly impacted by ICD–10 updates based only on the first 9 months of the 12-month performance period (for example, January 1, 2018, through September 30, 2018, for the 2018 MIPS performance PO 00000 Frm 00011 Fmt 4701 Sfmt 4700 59845 period). We noted that performance on measures that are not significantly impacted by changes to ICD–10 codes would continue to be assessed on the full 12-month performance period (January 1 through December 31). Lastly, we finalized that we will publish the list of measures requiring a 9-month assessment process on the CMS website by October 1st of the performance period if technically feasible, but by no later than the beginning of the data submission period (for example, January 2, 2019, for the 2018 MIPS performance period). As part of our technical updates to § 414.1380(b)(1) outlined in section III.I.3.i.(1)(b) of this final rule, these previously finalized policies are now referenced at § 414.1380(b)(1)(viii). We remain concerned about instances where clinical guideline changes or other changes to evidence supporting a measure occur during the performance period that may significantly impact a measure. Clinical guidelines and protocols developed by clinical experts and specialty medical societies often underpin quality measures. At times, measure stewards must amend quality measures to reflect new research and changed clinical guidelines, and sometimes, as a result of the change in these guidelines, adherence to guidelines in the existing measures could result in patient harm or otherwise provide misleading results as to good quality care. We sought comment in the CY 2018 Quality Payment Program final rule regarding whether we should apply scoring flexibility to measures significantly impacted by clinical guideline changes (82 FR 53716). We refer readers to the CY 2019 PFS proposed rule for a summary of the comments we received (83 FR 35949 through 35950). We remain concerned that findings of evidence-based research, providing the basis for sound clinical practice guidelines and recommendations that are the foundation of a quality measure, may change outside of the rulemaking cycle. As the clinical evidence and guidelines change, approved measures may no longer reflect the most up-todate clinical evidence and could be contrary to patient well-being. There may be instances in which changes to clinical guidelines are so significant, that an expedited review is needed outside of the rulemaking cycle because measures may result in a practice that is harmful to patients. To further align with policies adopted within other value based programs such as the Hospital VBP Program (83 FR 20409), we proposed to suppress a measure without rulemaking, if during the performance period a measure is E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59846 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations significantly impacted by clinical guideline changes or other changes that CMS believes may pose patient safety concerns (83 FR 35950). We would rely on measure stewards for notification in changes to clinical guidelines. We will publish on the CMS website suppressed measures whenever technically feasible, but by no later than the beginning of the data submission period. In the CY 2019 PFS proposed rule (83 FR 35950), we proposed policies to provide scoring flexibility in the event that we need to suppress a measure during a performance period. Scoring for a suppressed measure would result in a zero achievement points for the measure and a reduction of the total available measure achievement points by 10 points. We believe that this approach effectively removes the impact of the eligible clinician’s inability to receive measure achievement points for the measure, if a submitted measure is later suppressed. We also proposed to add a new paragraph at § 414.1380(b)(1)(vii) that, beginning with the 2019 MIPS performance period, CMS will reduce the total available measure achievement points for the quality performance category by 10 points for MIPS eligible clinicians that submit a measure significantly impacted by clinical guideline changes or other changes that CMS believes may pose patient safety concerns (83 FR 35950). We requested comments on the proposal above. These comments and our responses are discussed below. Comment: A few commenters supported the proposal because it holds the clinician harmless from clinical guideline changes that impact quality measures. One commenter noted that it is important that clinicians are protected from any adverse impacts on their scoring when they are following updated clinical guidelines to ensure proper patient care and safety. Response: We appreciate the support of the proposal. Comment: Several commenters did not support the proposal. Commenters questioned whether there would be an expectation that the clinician would continue collecting data on the measure, or whether they would be allowed to submit the measure with less than 12 months’ data for the suppressed measure. A few commenters stated the policy should only be applied if the clinical guideline change relates to patient harm or patient safety, in which case data collection on the quality measure should cease immediately. A few commenters indicated that clinicians invest significant time and resources to assess and improve their VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 performance over the course of the performance period, and thus suppressing the scoring of a quality measure, unless patient harm is involved, does not appropriately recognize these efforts. One commenter suggested that CMS establish an attestation process through the EIDM system to allow clinicians the option to attest their intent to report the measure, and CMS should adjust their scoring accordingly. Response: We appreciate the commenters’ suggestions. There are rare instances in which changes to clinical knowledge and guidelines can significantly impact measure specifications and the intent of the measure, which we believe requires suppression of scoring so as to encourage the clinicians to follow the guidelines that are best for the patient, rather than tracking the guidelines that were finalized in the measure set, which may negatively impact patient care. Clinical guideline changes that occur between rulemaking cycles would need to be significant enough that the change in the most up-to-date clinical evidence could result in patient harm if the clinician does not follow these new guidelines or otherwise provide misleading results as to what is measured as good quality care. We believe there are rare instances in which we should not delay our support of the use of the most current clinical evidence by continuing to require the collection of data and scoring the measure until the next rulemaking cycle. For example, a guideline may be updated because clinical evidence indicates that a new medication should replace a medication specified in a quality measure. If this occurs between rulemaking cycles, we would not want the scoring policy to disadvantage the clinicians adopting the updated guideline and using the recommended medication. We envision that this policy would be applied in two circumstances. First, there is a newly issued or updated guideline where there is wide consensus that would result in a significant change to a quality measure. In these cases, it would be expected that clinicians would adopt clinical processes to support the new guideline which may not be compatible with the existing measures and could provide misleading results or patient harm. In this case, we anticipate the quality measure would be reviewed and updated during the next rulemaking process. Second, we envision using this policy in rare cases where there is a new or revised guideline, even if there is no broad consensus within the specialty, because some clinicians will begin to PO 00000 Frm 00012 Fmt 4701 Sfmt 4700 adopt the new guideline which would not be consistent with the quality measures and scoring the measure could cause misleading results for those clinicians. We believe it important to suppress the measure until guideline and quality measure are reviewed by the Measures Application Partnership (MAP) and other processes to support the Annual List of Measures, including rulemaking. We do not envision using this policy solely based on indications that guideline revisions are anticipated but not completed. Until the guideline is updated, clinicians would be expected to follow the existing guideline and it would not be prudent to use the scoring policy. Nor would we activate the policy if the guideline change does not significantly impact the measure results. In the event of the need for the special scoring policy, we would communicate to clinicians through multiple channels regarding the changes. We appreciate that clinicians invest significant time and resources to select measures, we also believe it is critical that the measure results do not cause patient harm or otherwise harm clinician performance by scoring potentially misleading data. We believe suppressing the measure and reducing the total possible achievement points by 10 would recognize this effort by not forcing clinicians in the middle of a performance to select a new measure to report. We appreciate the time and resources clinicians expend to collect data for a quality measure; however, we believe the policy will only be used in rare occasions, which will limit disruption to clinicians. We also believe that the policy will not disadvantage the clinician and will ‘‘hold harmless’’ any clinician submitting data on the measure. Scoring would be suppressed for any clinician that submitted data on the measure prior to the announcement. Similarly, given how rarely we anticipate we will need to use this policy, we do not believe we require a process for attestation regarding which measures will be selected prior to the performance period. Comment: A few commenters recommended regular communication between CMS and measure stewards and supported the proposal that it would be the responsibility of the measure steward to notify CMS of changes to the clinical guidelines that may impact existing quality measures. One commenter requested that CMS allow multiple sources, rather than just measure stewards, to identify potential significant changes to clinical guidelines that may pose patient safety E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations risks. Another commenter stated that only measure stewards should notify CMS of significant changes to clinical guidelines. Response: We regularly monitor changes to quality measures and work closely with clinical organizations that maintain clinical guidelines and measure stewards to identify quality measures impacted by significant changes to clinical guidelines during the performance period. We will mainly rely on measure stewards to identify significant changes, especially those relating to potential patient harm. We clarify that measure stewards are not necessarily the owner and/or developer of the clinical guidelines. In many instances measure stewards defer to the clinical organizations or stakeholders who own, maintain and update the clinical guideline when changes are warranted. We intend to continue to work collaboratively with measure stewards, clinical organizations, measure owners and other key stakeholders responsible for the maintenance of these guidelines prior to deciding to suppress the scoring of a measure. As noted above, if we decide to suppress these measures, we would notify clinicians through multiple means. After consideration of public comments, we are finalizing a modification of our proposal and adding a new paragraph at § 414.1380(b)(1)(vii) stating that, beginning with the 2021 MIPS payment year, we will reduce the denominator of available measure achievement points for the quality performance category by 10 points for MIPS eligible clinicians for each measure submitted that is significantly impacted by clinical guideline changes or other changes when we believe adherence to the guidelines in the existing measures could result in patient harm or otherwise provide misleading results as to good quality care. To clarify, we regularly monitor changes to quality measures and clinical guidelines and we will rely mainly on measure stewards, who often defer to the clinical organizations or other stakeholders who own, maintain and update the clinical guideline when a guideline change is warranted, for notification in changes to clinical guidelines. We will publish on the CMS website suppressed measures whenever technically feasible, but by no later than the beginning of the data submission period. (vii) Scoring for MIPS Eligible Clinicians That Do Not Meet Quality Performance Category Criteria In the CY 2018 Quality Payment Program final rule (82 FR 53732), we VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 finalized that, beginning with the 2021 MIPS payment year, we will validate the availability and applicability of quality measures only with respect to the collection type that a MIPS eligible clinician utilizes for the quality performance category for a performance period, and only if a MIPS eligible clinician collects via claims only, MIPS CQMs only, or a combination of MIPS CQMs and claims collection types. We will not apply the validation process to any data collection type that the MIPS eligible clinician does not utilize for the quality performance category for the performance period. We sought comment on how to modify the validation process for the 2021 MIPS payment year when clinicians may submit measures collected via multiple collection types. As discussed in section III.I.3.h.(1)(b) of this final rule, we proposed to revise our terminology regarding data submission. This updated terminology will more accurately reflect our current submissions and validation policies. In the CY 2019 PFS proposed rule (83 FR 35950), we proposed to modify our validation process to provide that it only applies to MIPS CQMs and the claims collection type, regardless of the submitter type chosen. For example, this policy would not apply to eCQMs even if they are submitted by a registry. We note that a MIPS eligible clinician may not have available and applicable quality measures. If we are unable to score the quality performance category, then we may reweight the clinician’s score according to the reweighting policies described in sections III.I.3.i.(2)(b)(ii) and III.I.3.i.(2)(b)(iii) of this final rule. We did not receive any comments on this proposal. We are finalizing our proposal to modify our validation process to provide that it only applies to MIPS CQMs and the claims collection type, regardless of the submitter type chosen. (viii) Small Practice Bonus In the CY 2018 Quality Payment Program final rule (82 FR 53788), we finalized at § 414.1380(c)(4) to add a small practice bonus of 5 points to the final score for the 2020 MIPS payment year for MIPS eligible clinicians, groups, APM Entities, and virtual groups that meet the definition of a small practice as defined at § 414.1305 and submit data on at least one performance category in the 2018 MIPS performance period. We continue to believe an adjustment for small practices is generally appropriate due to the unique challenges small practices experience related to financial and other resources, PO 00000 Frm 00013 Fmt 4701 Sfmt 4700 59847 as well as the performance gap we have observed (based on historical PQRS data) for small practices in comparison to larger practices. We believe a small practice bonus specific to the quality performance category is preferable for the 2021 MIPS payment year and future years. We believe it is appropriate to apply a small practice bonus points to the quality performance category based on observations using historical data, which indicates that small practices are less likely to submit quality performance data, less likely to report as a group and use the CMS Web Interface, and more likely to have lower performance rates in the quality performance category than other practices. We want the final score to reflect performance, rather than the ability and infrastructure to support submitting quality performance category data. We considered whether we should continue to apply the small practice bonus through bonus points in all 4 performance categories, but believe the need for doing so is less compelling. The improvement activities performance category already includes special scoring for small practices (please refer to § 414.1380(b)(3) and see section III.I.3.i.(1)(e) of this final rule for more information). In addition, for the Promoting Interoperability performance category, small practices can apply for a significant hardship exception if they have issues acquiring an EHR (see section III.I.3.h.(5) of this final rule). Finally, the cost performance category does not require submission of any data; therefore, there is less concern about a small practice being burdened by those requirements. For these reasons, we proposed to transition the small practice bonus to the quality performance category. Starting with the 2021 MIPS payment year, we proposed at § 414.1380(b)(1)(v)(C) to add a small practice bonus of 3 points in the numerator of the quality performance category for MIPS eligible clinicians in small practices if the MIPS eligible clinician submits data to MIPS on at least 1 quality measure (83 FR 35950). Because MIPS eligible clinicians in small practices are not measured on the readmission measure and are not able to participate in the CMS Web Interface, they generally have a quality performance category denominator of 60 total possible measure achievement points. Thus, our proposal of 3 measure bonus points generally represents 5 percent of the quality performance category score. As described in section III.I.3.i.(2)(b)(iii) of this final rule, for clinicians in many small practices, the E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59848 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations quality performance category weight may be up to 85 percent of the final score. (For example, if a small practice applies for the Promoting Interoperability significant hardship application and does not meet the sufficient case minimum for cost measures, then the weights of Promoting Interoperability and cost performance categories are redistributed to quality and the quality performance category weight would be 85 percent.) With a weight of 85 percent, a small practice bonus of 3 points added to the quality performance category will result in 4.25 bonus points added to the final score for clinicians in small practices.29 We believe this is appropriate because it is similar to the impact of the small practice bonus we finalized for the 2020 MIPS payment year (5 points added to the final score). Although we recognize that the impact of the small practice bonus for MIPS eligible clinicians in small practices who do not receive reweighting for the cost and/or Promoting Interoperability performance categories will be less than 4.25 points added to the final score, we believe a consistent approach is preferable for simplicity, and we do not believe that a larger bonus is appropriate as that could potentially inflate the quality performance category score and the final score and mask poor performance. We requested comments on the proposal above. These comments and our responses are discussed below. Comment: Some commenters supported the proposal and recommended that CMS continue to evaluate the least complicated method to apply the small practice bonus in future years. One commenter indicated that a small practice bonus should be retained as long as possible to support small practices. A few commenters recommended stability over several performance periods for the small practice bonus, with incentives maintained over time with no changes from year-to-year. One commenter recommended that CMS codify the small practice bonus for at least 3 years. Response: We will evaluate MIPS data to determine whether any future adjustment is still needed based on analysis of the performance of small group practices compared to larger practices. While we appreciate commenters’ recommendations for stability in the bonus over time, we believe that we must be guided by the annual analysis of small practices’ experience with the Quality Payment 29 We get 4.25 points using the following calculation: (3 measure bonus point/60 total measure points) * 85 percent * 100 = 4.25. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 Program to determine if the adjustment is still warranted. Any extension to the small practice bonus would be proposed through future rulemaking. Comment: One commenter recommended bonus points be applied evenly across the following performance categories: Quality; improvement activities; and Promoting Interoperability. Another commenter indicated that it did not support a bonus based on the size or location of the practice and recommended aligning the four performance categories and awarding bonuses for activities that apply across the performance categories. One commenter recommended that the clinician be allowed the option to have bonus points added to a performance category of his or her choice. A few commenters stated that small practices are consistently disadvantaged compared to large health systems for not only quality reporting, but also requirements of other performance categories including Promoting Interoperability and improvement activities. Response: We considered dividing the small practice bonus between the performance categories; however, we believe that spreading the bonus across performance categories may not be appropriate, and the other performance categories already take small practices into account. As stated earlier, the improvement activities performance category already includes special scoring for small practices. The Promoting Interoperability performance category has a hardship exception for small practices. The cost performance category does not require submission of any data. For these reasons, we believe that it is appropriate for the small practice bonus to be in the quality performance category. Comment: Many commenters did not support reducing the small practice bonus from 5 points in the final score to 3 measure bonus points in the quality performance category because of concerns that small practices will receive less points, which may not support small practices sufficiently. Several commenters stated that the bonus needs to be significant enough so that adjustments provide more equitable scoring to small practices. One commenter recommended that if the bonus is applied in the quality performance category, 5 points should be awarded. Response: We understand commenters’ concerns. We recently estimated quality performance category scores for the 2019 MIPS performance period using data from the 2017 MIPS performance period. This new data was PO 00000 Frm 00014 Fmt 4701 Sfmt 4700 not available before the publication of the proposed rule. In this new analysis, we found that the number of eligible clinicians whose quality performance category was reweighted to 85 percent of the final score was lower than we anticipated. We found that for approximately three-fourths of the clinicians in small practices (and those not subject to the APM scoring standard), quality was weighted between 45 and 60 percent when we applying our proposed CY 2019 performance period policies to MIPS year 1 data. Thus, the 3 bonus points proposed (which generally represents 5 percent of the quality performance category score for small practices) would represent a lower overall bonus when added to the final score than we had originally anticipated. While we still believe that the small practice bonus should be applied to the quality category performance score, it was not our intention to lower the overall impact on the final score. With our updated impact analysis in this final rule, we discovered that trends identified when we originally established the small practice bonus still exist. For example, in the CY 2018 Quality Payment Program proposed rule (82 FR 30139 through 30140), we noted that clinicians in practices with more than 100 clinicians may perform better in the Quality Payment Program on average compared to clinicians in smaller practices. We believed this trend was due primarily to two factors: Participation rates and Web Interface reporting. While we estimate more clinicians in small practices are participating in MIPS in our updated model in this final rule compared to our estimates in the 2019 PFS proposed rule, we still see a gap in quality participation when comparing clinicians in small practices to clinicians in large practices (89.8 percent compared to 100.0 percent respectively). We also noticed a discrepancy in performance among those who submitted data for the quality performance category. Prior to applying a small practice bonus, the average quality score for submitters in small practices was 62 percent compared to 82 percent for clinicians in large groups. It is unclear whether the cause of the discrepancy is related to Web Interface reporting, to performance, or to factors related to data collection. While we continue to analyze the implications of these results, we believe increasing the small practice bonus from 3 to 6 measure bonus points for 1 year would be appropriate to ensure that we are correctly incentivizing participation E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations during the transition years without lowering the impact of the small practice bonus. The other bonuses in the quality performance category (for highpriority measures and end-to-end electronic reporting) are capped at 10 percent of the denominator of the quality performance category, which in almost all cases for small practices is 60 total possible measure achievement points. Setting the bonus at 6 points generally represents 10 percent of the quality performance category score. For those clinicians who have six measures and for whom the quality performance category weight is 45 percent, then the small practice bonus would equate to 4.5 final score points. For those with a quality performance category weight of 60 percent, the small practice bonus would equate to 6 final score points. We recognize that for some practices whose quality score is reweighted to 85 percent of their final score, this may account for a large part of the final score; however, based on the new CY 2017 MIPS performance period data, we do not believe this will be the case for a large proportion of small practices. On average, we estimate this change to the small practice bonus will add 4.4 points to the final score for clinicians in small practices who submit quality information to MIPS. We want to remind readers that the small practice bonus was only meant to be temporary and as we further analyze CY 2017 MIPS performance period data we expect that the bonus will likely be reduced or removed in future rulemaking. While we currently believe that it is appropriate due to the unique challenges small practices experience related to financial and other resources, as well as the performance gap for small practices in comparison to larger practices, we believe that upon further analysis of CY 2017 MIPS performance period data the small practice bonus may not address the underlying reasons for the disparate performance between small practices and other clinicians. As a result, we intend to revisit this bonus during next year’s rulemaking cycle. Comment: Many commenters stated that the small practice bonus should not be embedded in the quality performance category and should be a standalone bonus at the final score level to reduce complication in scoring, provide greater flexibility, and reduce burden on small practices. Several commenters stated that the quality performance category is contributing less to the final score, since it is being reduced from 50 percent to 45 percent, and may be reduced in the future, which would continually reduce the small practice bonus. A few commenters noted that moving the VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 bonus to the quality performance category provides additional scoring complexity and will not be equitable, since the bonus will be applied to small practices regardless of the number of measures submitted for the quality performance category. For example, the bonus of 3 points for a clinician being scored on one quality measure would translate to a higher contribution to the final score than applying a bonus of 3 points for a clinician being scored on 6 measures. One commenter was concerned that moving the small practices bonus to the quality performance category will remove the opportunity for a bonus from clinicians who do not, or cannot, report quality measures. Response: We believe it is more appropriate for the small practice bonus to reside in the quality performance category because small practices have different reporting options than larger practices (for example, only small practices are able to submit data via Medicare Part B claims, but they cannot do so via the Web Interface), and burdens associated with submitting data could affect the quality performance category score. We also believe there is at least one quality measure that is relevant to the vast majority of clinicians in the Quality Payment Program. The small practice bonus is available to any small practice submitting at least one quality measure. We reiterate that we have special policies to assist small practices in the improvement activities and Promoting Interoperability performance categories, which limit the need for a small practice bonus in those performance categories. The cost performance category does not require additional burden to submit information and does not have the same reporting restrictions as the quality performance category. Over time, we will monitor the weight of the quality performance category and the small practice contribution to the final score to determine if the amount of the small practice bonus needs to be adjusted. We acknowledge that moving the small practice bonus may add to the complexity of scoring, but, on balance, we believe it is appropriate to encourage the submission of quality measures. Also, we note that previously the small practice bonus was added to the final score regardless of the number of quality measures that were submitted. Although the bonus is now in the quality category, the equity of the bonus does not change with this policy. In addition, we will continue to monitor data to evaluate the performance of small practices in the quality performance category to PO 00000 Frm 00015 Fmt 4701 Sfmt 4700 59849 determine differences between small and large practices and propose any necessary changed in future rulemaking. Comment: One commenter requested clarification on how CMS will extend the small practice bonus to MIPS APMs. Response: The small practice bonus will be applied to the final quality performance category score for MIPS APMs at the MIPS APM entity-level. For further discussion on our MIPS APM scoring policies, we refer readers to section III.I.3.h.(6) of this final rule. Comment: One commenter indicated that the bonus score changes based on the reweighting of certain performance categories for clinicians, which they believe gives an advantage to clinicians who have a higher percentage of the score weighed to the quality performance category. One commenter did not support moving the bonus to the quality performance category, because the potential to reweight performance categories results in a bonus that is not predictable during the performance period for clinicians, who do not know which performance categories will be reweighted. Response: We appreciate that there might be differences in the reweighting of performance categories for small practices. As stated previously, we believe the quality performance category is an important component of the Quality Payment Program. While it was our intention to apply a bonus to the quality performance category with a cap approximately equal to the final score small practice bonus for the 2018 MIPS performance period/2020 MIPS payment year, we recognize that due to reweighting, the magnitude of the bonus will vary; however, in order to reduce complexity, we believe that a uniform bonus of 6 measure bonus points added to the numerator for quality is appropriate. As discussed in our response above, the policy is consistent with our other quality performance category bonuses because, for most clinicians, 6 measure bonus points is 10 percent of the 60-point denominator within the quality performance category. In addition, clinicians can predict whether their scores will be reweighted based on eligibility and special status information in the lookup tool. We will monitor the extent to which reweighting the quality performance category contribution to the final score affects quality measure bonus points awarded and so that we may keep the bonuses as equitable as possible. Comment: A few commenters indicated that the small practice bonus should be extended to rural practices and different practice sizes. One E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59850 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations commenter recommended extending the bonus to all rural practices, regardless of practice size, because of the belief that all rural practices struggle with access to resources. One commenter indicated a belief that the program offers few bonus points and opportunities for high scores for small and rural practices, which may result in a skewed scoring system that rewards large groups with resources to support participation. One commenter recommended that the small practice bonus be available to groups with 10 or less participants, to align the definition with virtual group requirements. One commenter indicated that groups with more than 15 clinicians should be considered a small practice for purposes of the bonus. Response: As discussed in the CY 2018 Quality Program final rule (82 FR 53778), we observed that performance for rural MIPS eligible clinicians is very similar to performance for non-rural MIPS clinicians once we account for practice size, so we do not believe a bonus for MIPS clinicians practicing in a rural setting is appropriate at this time. Additionally, we discussed in the CY 2018 Quality Payment Program final rule (82 FR 53777) that we believe it is important to maintain a consistent definition of small practices within the Quality Payment Program. In addition, we have not seen discrepancies between simulated MIPS final scores for practices of 16 to 24 clinicians and for practices of 15 or fewer clinicians. However, we will continue to monitor this issue and assess whether there are scoring differences between small rural and small urban practices and, if so, address it in future rulemaking. Comment: One commenter requested that CMS articulate how the policies proposed align with other CMS efforts to support the long-term, sustainable transformation of small practices and those serving rural and underserved communities. Response: We recognize the unique challenges that eligible clinicians in small practices face and have established a unique set of policies to reduce their participation burden and ease their transition into the program. The special policies include the provisions related to the assignment of 3 points for measures that do not meet data completeness criteria which are finalized in section III.I.3.i.(1)(b)(v) of this final rule; the significant hardship exception for Promoting Interoperability performance category and the associated reweighting policies available for small practices that do not have CEHRT (2018 Quality Payment Program final rule (82 FR 53683)); special scoring provisions available for the improvement activities VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 performance category (82 FR 53656), and the provisions related to the lowvolume threshold at section III.I.3.c. of this final rule. We are also continuing the Small, Underserved, and Rural Support initiative, which provides nocost technical assistance to MIPS eligible clinicians in small practices. The initiative offers customized, one-onone support to help MIPS eligible clinicians in small practices familiarize themselves with the program requirements, develop a strategy to successfully participate, and continue improving outcomes for beneficiaries. See: https://qpp.cms.gov/about/smallunderserved-rural-practices for further information. As discussed in the response above, we have estimated quality performance category scores using data from the 2017 MIPS performance period. As a result of this new data that was not available before the publication of the proposed rule we believe increasing the small practice bonus from 3 to 6 measure bonus points would be appropriate to ensure that we are correctly incentivizing participation without lowering the final score of small practices. The other bonuses in the quality performance category (for highpriority measures and end-to-end electronic reporting) are capped at 10 percent of the denominator of the quality performance category, which in almost all cases for small practices is 60 total possible measure achievement points. Setting the bonus at 6 points generally represents 10 percent of the quality performance category score. After consideration of public comments, we are not finalizing as proposed the proposal to amend § 414.1380(b)(1)(v)(C) to add, beginning with the 2021 MIPS payment year, a small practice bonus of 3 measure bonus points in the numerator of the quality performance category for MIPS eligible clinicians in small practices if the MIPS eligible clinician submits data to MIPS on at least 1 quality measure. Instead, based on the rationale discussed previously, we are finalizing the amendment of § 414.1380(b)(1)(v)(C) to add, beginning with the 2021 MIPS payment year, a small practice bonus of 6 measure bonus points in the numerator of the quality performance category for MIPS eligible clinicians in small practices if the MIPS eligible clinician submits data to MIPS on at least 1 quality measure. (ix) Incentives To Report High-Priority Measures In the CY 2017 Quality Payment Program final rule, we established a cap on high-priority measure bonus points PO 00000 Frm 00016 Fmt 4701 Sfmt 4700 for the first 2 years of MIPS at 10 percent of the denominator (total possible measure achievement points the MIPS eligible clinician could receive in the quality performance category) of the quality performance category (81 FR 77294). As part of our proposed technical updates to § 414.1380(b)(1) discussed in section III.I.3.i.(1)(b) of this final rule, our previously established policy on incentives to report highpriority measures is now referenced at § 414.1380(b)(1)(v)(A). In the CY 2019 PFS proposed rule, we proposed to maintain the cap on measure bonus points for reporting high-priority measures for the 2021 MIPS payment year, and to amend § 414.1380(b)(1)(v)(A)(1)(ii), accordingly (83 FR 35951). We requested comments on the proposal above. These comments and our responses are discussed below. Comment: One commenter supported the proposal to maintain the cap on measure bonus points for reporting high-priority measures for the 2019 performance period/2021 MIPS payment year. Response: We thank the commenter for its support of our proposal. After consideration of public comments, we are finalizing our proposal to maintain the cap on measure bonus points for reporting high-priority measures for the 2021 MIPS payment year, and to amend § 414.1380(b)(1)(v)(A)(1)(ii), accordingly. We established the scoring policies for high-priority measure bonus points in the CY 2017 Quality Payment Program final rule (81 FR 77293). We noted that, in addition to the required measures, CMS Web Interface reporters may also report the CAHPS for MIPS survey and receive measure bonus points for submitting that measure (81 FR 77293). We refer readers to § 414.1380(b)(1)(v)(A) for more details on the high-priority measure bonus points scoring policies. For the 2021 MIPS payment year, we proposed to modify the policies finalized in the CY 2017 Quality Payment Program final rule (and amend § 414.1380(b)(1)(v)(A) accordingly) to discontinue awarding measure bonus points to CMS Web Interface reporters for reporting high-priority measures (83 FR 35951). As we continue to move forward in implementing the MIPS program, we no longer believe that it is appropriate to award CMS Web Interface reporters measure bonus points to be consistent with other policies regarding selection of measures. Based on additional data analyses since the first-year policy was implemented, E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations we have found that practices that elect to report via CMS Web Interface generally perform better than other practices that select other collection types. Therefore, the benefit of the bonus points is limited and instead we believe will create higher than normal scores. Bonus points were created as transition policies which were not meant to continue through the life of the program. Measure bonus points are also used to encourage the selection of additional high-priority measures. As the program matures, we have established other policies related to measures selection, such as applying a cap of 7 measure achievement points if a clinician selects and submits a measure that has been topped out for 2 or more years; however, we have excluded CMS Web Interface reporters from the topped out policies because reporters have no choice in measures. By the same logic, since CMS Web Interface reporters have no choice in measures, we do not believe it is appropriate to continue to provide additional high-priority measure bonuses for reporting CMS Web Interface measures. We note the CMS Web Interface users may still elect to report the CAHPS for MIPS survey in addition to the CMS Web Interface, and if they do, they would receive the high priority bonus points for reporting the survey. We requested comments on the proposal above. These comments and our responses are discussed below. Comment: A few commenters supported the proposal to discontinue awarding high-priority measure bonus points to CMS Web Interface reporters because it strengthens the incentive to report high-priority measures for those who actively elect to report these measures and reduces the advantage for the large practices that are able to report through CMS Web Interface. One commenter expressed support for the proposal because groups who report via Web Interface perform better than groups who use alternative data collection types, have an increased probability of earning higher quality performance category and overall higher MIPS scores, and can still earn bonus points for reporting CAHPS for MIPS survey measures. Response: We thank the commenters for their support as we look for ways to improve our scoring policy. Comment: Several commenters did not support the proposal to remove high-priority bonus points for CMS Web Interface reporters. One commenter stated it would disincentivize clinicians and groups from participating in APMs and stated that ACOs do not have an VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 alternative submission method. Another commenter suggested that the bonus points should continue for non-MIPS APM participants because these submitters voluntarily choose a larger and more difficult and complex set of measures than are required. A few commenters stated that there is not an option to submit additional highpriority measures to earn these bonus points and that this proposal disadvantages ACOs which have demonstrated a high commitment to quality as evidenced by recent MIPS performance feedback reports. One commenter recommended that CMS should not remove all bonus points until it proposes to do the same for the other collection types. A few commenters suggested delaying removal of the bonus points to allow clinicians sufficient notice and until further information and insight is gained about performance in these measures. One commenter stated that the policy penalizes Web Interface reporters for their commitment to measures that truly reflects their practices. Response: The high priority measure bonus points were intended to encourage the selection of certain measures. As we work towards improving our scoring policy to align with our goals of improving quality of care, we no longer believe we should award bonus points to CMS Web Interface reporters because they do not select individual measures to report, rather the Web Interface is a measurement set. This bonus policy was meant to be temporary, and we believe that as the MIPS program goes into its third year it is an appropriate time to begin to limit the assignment of high priority bonus points. While we recognize the commenters’ concerns, the removal of the bonus was not intended to penalize Web Interface reporters and we still have several special policies available for Web Interface reporters. We have excluded CMS Web Interface reporters from the topped out measure cap (82 FR 53576), so although they are no longer able to receive this bonus, they are still able to receive maximum achievement points for all measures, even though some of the CMS Web Interface measures may be considered topped out. Additionally, CMS Web Interface reporters are still able to receive measure bonus points for reporting the CAHPS for MIPS survey and for end-to-end reporting. We will consider commenters’ concerns in future rulemaking. After consideration of public comments, we are finalizing our proposal, beginning with the 2021 MIPS payment year, to discontinue awarding PO 00000 Frm 00017 Fmt 4701 Sfmt 4700 59851 measure bonus points to CMS Web Interface reporters for reporting highpriority measures and to amend § 414.1380(b)(1)(v)(A) accordingly. As part of our move towards fully implementing the high value measures as discussed in section III.I.3.h.(2)(b)(iv) of this final rule, we believe that bonus points for high priority measures for all collection types may no longer be needed, and as a result, we intend to consider in future rulemaking whether to modify our scoring policy to no longer offer high priority bonus points after the 2021 MIPS payment year (83 FR 35951). We thank commenters for suggestions and may consider them for future rulemaking. (x) Incentives To Use CEHRT To Support Quality Performance Category Submissions Section 1848(q)(5)(B)(ii) of the Act requires the Secretary to encourage MIPS eligible clinicians to report on applicable quality measures through the use of CEHRT. Under § 414.1380(b)(1)(xv), 1 bonus point is available for each quality measure submitted with end-to-end electronic reporting, under certain criteria. In order to receive the bonus for end-toend reporting, eligible clinicians must use the 2015 Edition CEHRT. We refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77297) and section III.I.3.h.(2)(b)(i) of this final rule for further discussion on our certification requirements for the endto-end reporting bonus. As part of our proposed technical updates to § 414.1380(b)(1) discussed in section III.I.3.i.(1)(b) of this final rule, our previously established electronic endto-end reporting bonus point scoring policy is now referenced at § 414.1380(b)(1)(v)(B). In the CY 2019 PFS proposed rule, we proposed to maintain the cap on measure bonus points for end-to-end electronic reporting for the 2021 MIPS payment year (83 FR 35951). We also proposed to continue to assign bonus points for end-to-end electronic reporting for the 2021 MIPS payment year, as we have seen that this policy encourages electronic reporting. We proposed to amend § 414.1380(b)(1)(v)(B) accordingly. We requested comments on the proposal above. These comments and our responses are discussed below. Comment: Several commenters supported maintaining the bonus points for end-to-end electronic reporting for the 2021 MIPS payment year and requested that CMS continue to assign them in future years. One commenter E:\FR\FM\23NOR3.SGM 23NOR3 59852 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations amozie on DSK3GDR082PROD with RULES3 noted that continuing the bonus points beyond the 2021 MIPS payment year will allow clinicians in smaller practices who are not yet capable of end-to-end electronic reporting an opportunity to do so. Another commenter supported the bonus only if those that are not able to submit using end-to-end electronic reporting have access to CEHRT at no cost to the clinician. One commenter suggested that CMS continue the bonus points until the program is more mature and additional data on performance and reporting is gathered. A few commenters who supported maintaining the bonus points beyond the 2021 MIPS payment year, stated that the removal of the bonus points would result in increased administrative burden to CMS and clinicians, and would adversely affect the ability for clinicians with limited quality measures available to earn bonus points. Response: While we signaled our intent to discontinue bonus points for end-to-end electronic reporting in the future (83 FR 35951), we are taking into consideration the suggestions we received on additional ways we can incentivize and encourage these reporting methods for future rulemaking. After consideration of public comments, we are finalizing our proposals to continue to assign and maintain the cap on measure bonus points for end-to-end electronic reporting for the 2021 MIPS payment year and to amend § 414.1380(b)(1)(v)(B) accordingly. We also proposed to modify our endto-end reporting bonus point scoring policy based on the changes to the submission terminology discussed in section III.I.3.h.(1)(b) of this final rule (83 FR 35951). We proposed that the end-to-end reporting bonus can only apply to the subset of data submitted by direct, log in and upload, and CMS Web Interface that meet the criteria finalized in the CY 2017 Quality Payment Program final rule (81 FR 77297 through 77298). However, the end-to-end VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 reporting bonus would not be applied to the claims submission type because it does not meet the criteria discussed above. This is not a policy change but rather a clarification of our current process in light of the proposed terminology changes. We did not receive any comments on this proposal. After consideration of public comments, we are finalizing our proposals to modify our end-to-end reporting bonus point scoring policy based on the changes to the submission terminology and only apply the bonus to the subset of data submitted by direct, log in and upload, and CMS Web Interface that meet the criteria finalized in the CY 2017 Quality Payment Program final rule (81 FR 77297 through 77298). As discussed in section III.I.3.i.(1)(b)(x) of this final rule, we believe that in the future, bonus points for end-to-end reporting for all submission types will no longer be needed as we move towards fully implementing the program, and as a result we intend to consider in future rulemaking modifying our scoring policy to no longer offer end-to-end reporting bonus points after the 2021 MIPS payment year (83 FR 35951). Consistent with the section 1848(q)(5)(B)(ii) of the Act, which requires the Secretary to encourage the use of CEHRT for quality reporting, we will continue to be committed to ways that we can incentivize and encourage these reporting methods. We invited comment on other ways that we can encourage the use of CEHRT for quality reporting. We thank commenters for suggestions and will consider them for future rulemaking. (xi) Calculating Total Measure Achievement and Measure Bonus Points (A) Calculating Total Measure Achievement and Measure Bonus Points for Non-CMS Web Interface Reporters In the CY 2017 and 2018 Quality Payment Program final rules (81 FR PO 00000 Frm 00018 Fmt 4701 Sfmt 4700 77300, and 82 FR 53733 through 53736, respectively), we established the policy for calculating total measure achievement and measure bonus points for Non-CMS Web Interface reporters. We refer readers to § 414.1380(b)(1) for more details on these policies. We did not propose any changes to the policy for scoring submitted measures collected across multiple collection types; however, we provided a summary of how this policy will be scored using our new terminology (83 FR 35952). We noted that CMS Web Interface and facility-based measurement each have a comprehensive set of measures that meet the proposed MIPS category requirements. As a result, we did not combine CMS Web Interface measures or facility-based measurement with other ways groups can be scored for data submitted for MIPS (other than CAHPS for MIPS, which can be submitted in conjunction with the CMS Web Interface). We refer readers to section III.I.3.i.(1)(d) of this final rule for a description of our policies on facilitybased measurement (83 FR 35956 through 35963). Although we have established a policy to account for scoring in circumstances when the same measure is collected via multiple collection types, we anticipate that this will be a rare circumstance and do not encourage clinicians to submit the same measure collected via multiple collection types. Table 51 is included in this final rule for illustrative purposes and clarity due to the changes in terminology discussed in section III.I.3.h.(1)(b) of this final rule (83 FR 35893 through 35895). For further discussion of this example, we refer readers to the CY 2018 Quality Payment Program final rule (82 FR 53734). BILLING CODE 4120–01–P E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 59853 TABLE 51: Example Assigning Total Measure Achievement and Bonus Points for an Individual MIPS Eligible Clinician Who Submits Measures Collected Across Multiple Collection Measure Achievement Points Six Scored Measures High-Priority Measure Bonus Points 7.1 7.1 (Outcome measure with highest achievement (required outcome measure does not receive bonus points) Measure A (Outcome) Measure C (high priority patient safety measure that meets requirements for additional bonus points) 6.2 (points not considered because it is lower than the 8.2 points for the same claims 5.1 (points not considered because it is lower than the 4.1 (points not considered because it is lower than the 7.1 points for the same MIPSCQM) Measure A (Outcome) amozie on DSK3GDR082PROD with RULES3 Measure C (High priority patient safety measure that meets requirements for additional bonus Measure D (outcome measure <50% of data submitted) 6.0 No bonus points because the MIPSCQMof the same measure satisfies requirement for outcome measure. 6.0 (no high priority bonus points because below data 1.0 Measure I (high priority patient safety measure that is below case VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 No bonus (Bonus applied to the MIPS CQMs) (no high priority bonus points because below PO 00000 Frm 00019 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.066</GPH> Measure B Incentive for CEHRT Measure Bonus Points Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations BILLING CODE 4120–01–C We did not propose any changes to our policy regarding scoring measure achievement points and bonus points when using multiple collection types for non-Web Interface MIPS eligible clinicians in the quality performance category for the 2019 MIPS performance period. amozie on DSK3GDR082PROD with RULES3 (B) Calculating Total Measure Achievement and Measure Bonus Points for CMS Web Interface Reporters In the CY 2017 and 2018 Quality Payment Program final rules (81 FR 77302 through 77306, and 82 FR 53736 through 82 FR 53737, respectively), we finalized the scoring policies for CMS Web Interface reporters. As part of our technical updates to § 414.1380(b)(1) discussed in section III.I.3.i.(1)(b) of this final rule, our previously established policies for CMS Web Interface reporters are now referenced at § 414.1380(b)(1)(i)(A)(2)(i) and (b)(1)(v)(A). (xii) Future Approaches To Scoring the Quality Performance Category As we discuss in section III.I.3.h.(2)(b)(iv) of this final rule, we anticipate making changes to the quality performance category to reduce burden and increase the value of the measures we are collecting. We discussed that existing measures have differing levels of value and our approaches for implementing a system where points are awarded based on the value of the measure. Should we adopt these approaches, we anticipate needing to modify our scoring approaches accordingly. In addition, we have received stakeholder feedback requesting that we simplify scoring for the quality performance category. Therefore, we solicited comment on the following approaches to scoring that we may consider in future rulemaking and whether these approaches move the clinicians towards reporting high value measures and more accurate VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 performance measurement (83 FR 35954 through 35955). One option for simplification is restructuring the quality requirements with a pre-determined denominator, for example, 50 points, but no specific requirements regarding the number of measures that must be submitted. Further, we would categorize MIPS and QCDR measures by value, because we recognize that not all measures are created equal. We seek to ensure that the collection and submission of data is valuable to clinicians and worth the cost and burden of collection of information. A system to classify measures as a particular value (for example, gold, silver, or bronze) is discussed in section III.I.3.h.(2)(b)(iv) of this final rule. In this approach, the highest tier would include measures that are considered ‘‘gold’’ standard, such as outcome measures, composite measure, or measures that address agency priorities (such as opioids). The CAHPS for MIPS survey, which collects patient experience data, may also be considered a high-value measure. Measures considered in the second tier, or at a ‘‘silver’’ standard, would be process measures that are directly related to outcomes and have a good gap in performance (there is no high, unwavering performance) and demonstrate room for improvement, or topped out outcome measures. Lower value measures, such as standard of care process measures or topped out process measures, would have scoring caps in place that would reflect the measure’s status as a ‘‘bronze measure.’’ In this scenario, we could envision awarding points for achievement as follows: Up to 15 to 20 points in the top tier; up to 10 points in the next tier; and up to 5 points in the lowest tier. Similar to the structure of the improvement activities performance category, a clinician that chooses a top-tier measure would not have to submit as many measures to MIPS. We would still want to ensure the PO 00000 Frm 00020 Fmt 4701 Sfmt 4700 submission of high value measures and might include requirements that restrict the number of lower tier measures that could be submitted; alternatively, we could add a requirement that a certain number of higher tier measures would need to be submitted. With this approach, we could still incentivize reporting on high-priority measures by classifying them as ‘‘gold’’ standard measures which would be eligible for up to 15 to 20 achievement points. Alternatively, we could keep our current approach for the quality performance category requiring 6 measures including one outcome measure, with every measure worth up to 10 measure achievement points in the denominator but change the minimum number of measure achievement points available to vary by the measure tier. For example, high-tier measures could qualify for high priority bonus and/or have a higher potential floor (for example, 5 measure achievement points instead of the floor of 3 measure achievement points for ‘‘gold’’ standard measures, which would be eligible for up to 10 measure achievement points.); whereas low-tier measures could have a lower floor (for example, 1 measure achievement point instead of the floor of 3 measure achievement points for ‘‘bronze standard’ measures). Taking into consideration the potential future quality performance category change, we also believe that removing the validation process to determine whether the eligible clinician has measures that are available and applicable would simplify the quality performance category significantly. Several stakeholders have expressed their confusion with the validation process. A move to sets of measures in the quality performance category, potentially with some criteria to define the clinicians for whom these measures are applicable, would eliminate the need for a validation process for measures that are available and E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.067</GPH> 59854 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations applicable. Moving to sets of measures would also enable us to develop more robust benchmarks. We also believe that in the next few years, we could remove the validation process for measures that are available and applicable if we set the denominator at a pre-determined level (as outlined in the example above at 50 points) and let clinicians determine the best method to achieve 50 points. For the 2019 and 2020 MIPS payment years, MIPS eligible clinicians and groups who report on QCDR measures that do not have an available benchmark based on the baseline or performance period but meet data completeness are assigned a score of 3 measure achievement points (small practices receive 3 points regardless of whether they meet data completeness). Through stakeholder engagement, particularly feedback provided by QCDRs who have developed their own measures, we have heard that MIPS eligible clinicians are hesitant to report QCDR measures without established benchmarks. Eligible clinicians have voiced concern on reporting on QCDR measures without benchmarks because they are not certain that a benchmark could be calculated and established for the MIPS performance period, and they would therefore be limited to a 3-point score for that QCDR measure. In addition, QCDRs have inquired about the possibility of creating QCDR benchmarks. To encourage reporting of QCDR measures, we sought comment on an approach to develop QCDR measure benchmarks based off historical measure data. This may require QDCRs to submit historical data in a form and manner that meets benchmarking needs as required by CMS. We anticipate that the historical QCDR measure data would need to be submitted at the time of selfnomination of the QCDR measure, during the self-nomination period. Detailed discussion of the selfnomination period timeline and requirements can be found in section III.I.3.k of this final rule. Our concern with utilizing historical data provided by QCDRs to develop benchmarks is whether QCDRs have the capability to filter through their historical measure data to extract only data from MIPS eligible clinicians and groups prior to submitting the historical data to CMS for QCDR measure benchmarking consideration. Furthermore, once the historical data is submitted by the QCDR, CMS would analyze the data to ensure that it met benchmarking standards prior to it being accepted to form a benchmark. However, to perform this analysis CMS may need additional data elements such as the sources of the VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 data, data completeness, and the collection period. In addition to seeking comment on developing QCDR measure benchmarks from historical data, we also solicited comment as to how our aforementioned concerns may be addressed in future rulemaking. We also recognize that improving the electronic capture, calculation, and reporting of quality measures is also an important component of reducing provider burden. We invited comment on how we can incorporate incentives for the use of electronic clinical quality measurement into the future approaches described under this section, as well as other ways to encourage more efficient technology-enabled measurement approaches. We solicited comment on these approaches and other approaches to simplify scoring, provide incentives to submit more impactful measures that assess outcomes rather than processes, and develop data that can show differences in performance and determine clinicians that provide high value care (83 FR 35954 through 35955). We thank commenters for suggestions and will consider them for future rulemaking. (xiii) Improvement Scoring for the MIPS Quality Performance Category Percent Score Section 1848(q)(5)(D)(i) of the Act stipulates that, beginning with the second year to which the MIPS applies, if data sufficient to measure improvement is available, the improvement of the quality performance category score for eligible clinicians should be measured. To measure improvement, we require a direct comparison of data from one Quality Payment Program year to another (82 FR 52740). For more descriptions of our current policies, we refer readers to the CY 2018 Quality Payment Program final rule (82 FR 53737 to 53747). As part of our technical updates to § 414.1380(b)(1) discussed in section III.I.3.i.(1)(b) of this final rule, our previously established improvement scoring policies are now referenced at § 414.1380(b)(1)(vi). In the CY 2018 Quality Payment Program final rule, we adopted a policy that MIPS eligible clinicians must fully participate to receive a quality performance category improvement percent score greater than zero (82 FR 53743 through 53745). In § 414.1380(b)(1)(vi)(F), we determined ‘‘participation’’ to mean compliance with § 414.1330 and § 414.1340 in the current performance period. We issued a technical correction for the CY 2018 Quality Payment Year final rule, PO 00000 Frm 00021 Fmt 4701 Sfmt 4700 59855 replacing § 414.1330 with § 414.1335 since § 414.1335 is more specific because it discusses the quality performance category requirements. We finalized at § 414.1380(b)(1)(vi)(C)(4) that we would compare the 2018 performance to an assumed 2017 quality performance category achievement percent score of 30 percent if a MIPS eligible clinician earned a quality performance category score less than or equal to 30 percent in the previous year (82 FR 53744 through 53745). In the CY 2019 PFS proposed rule, we proposed to continue this policy for the 2019 MIPS performance period and amend § 414.1380(b)(1)(vi)(C)(4), accordingly (83 FR 35955). We proposed to compare the 2019 performance to an assumed 2018 quality performance category achievement percent score of 30 percent. The following is a summary of the public comments on the proposal and our responses: Comment: One commenter supported the proposal. Response: We thank the commenter for its support. After consideration of public comments, we are finalizing the proposal to continue our previously established policy for the 2019 MIPS performance period and amend § 414.1380(b)(1)(vi)(C)(4), accordingly. Specifically, we will compare the 2019 performance to an assumed 2018 quality performance category achievement percent score of 30 percent if a MIPS eligible clinician earned a quality performance category score less than or equal to 30 percent in the previous year. (xiv) Calculating the Quality Performance Category Percent Score Including Achievement and Improvement Points In the CY 2017 and CY 2018 Quality Payment Program final rules (81 FR 77300 and 82 FR 53747 through 53748, respectively), we finalized the policies on incorporating the improvement percent score into the quality performance category percent score. As part of our technical updates to § 414.1380(b)(1) discussed in section III.I.3.i.(1)(b) of this final rule, our previously established policies are now referenced at § 414.1380(b)(1)(vii). (c) Scoring the Cost Performance Category (i) Scoring Achievement in the Cost Performance Category For a description of the statutory basis and our existing policies for scoring achievement in the cost performance E:\FR\FM\23NOR3.SGM 23NOR3 59856 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations amozie on DSK3GDR082PROD with RULES3 category, we refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77308 through 77311) and the CY 2018 Quality Payment Program final rule (82 FR 53748 through 53749). In the CY 2017 Quality Payment Program final rule (81 FR 77308 through 77309), we established that we will determine cost measure benchmarks based on cost measure performance during the performance period. We also established that at least 20 MIPS eligible clinicians or groups must meet the minimum case volume that we specify for a cost measure in order for a benchmark to be determined for the measure, and that if a benchmark is not determined for a cost measure, the measure will not be scored. We proposed to codify these final policies at § 414.1380(b)(2)(i) (83 FR 35955 through 35956). While we did not receive any public comments for this proposal, we are finalizing our proposal to codify these final policies at § 414.1380(b)(2)(i). (ii) Scoring Improvement in the Cost Performance Category For a description of the statutory basis and our existing policies for scoring improvement in the cost performance category, we refer readers to the CY 2018 Quality Payment Program final rule (82 FR 53749 through 53752). Section 51003(a)(1)(B) of the Bipartisan Budget Act of 2018 modified section 1848(q)(5)(D) of the Act such that the cost performance category score shall not take into account the improvement of the MIPS eligible clinician for each of the second, third, fourth, and fifth years for which the MIPS applies to payments. We do not believe this change requires us to remove our existing methodology for scoring improvement in the cost performance category (see 82 FR 53749 through 53752), but it does prohibit us from including an improvement component in the cost performance category percent score for each of the 2020 through 2023 MIPS payment years. Therefore, we proposed to revise § 414.1380(b)(2)(iv)(E) to provide that the maximum cost improvement score for the 2020, 2021, 2022, and 2023 MIPS payment years is zero percentage points (83 FR 35955). Under our existing policy (82 FR 53751 through 53752), the maximum cost improvement score for the 2020 MIPS payment year is 1 percentage point, but due to the statutory changes and under our proposal, the maximum cost improvement score for the 2020 MIPS payment year would be zero percentage points. We also proposed at § 414.1380(a)(1)(ii) to modify the VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 performance standards to reflect that the cost performance category percent score will not take into account improvement until the 2024 MIPS payment year (83 FR 35956). The following is a summary of the public comments received on these proposals and our responses: Comment: A few commenters supported the proposals to set the maximum cost improvement score for the 2020, 2021, 2022, and 2023 MIPS payment years at zero percentage points. Response: We thank the commenter for their support. Comment: Several commenters requested that the cost performance category score be determined in a different manner because of the proposed inclusion of episode-based measures. A few commenters recommended that the new measures have a lower weight in determining the cost performance category score than the previously-established MSPB and total per capita cost measures. A few commenters recommend that similar to the quality performance category, only the 6 measures with the highest scores among those for which the clinician or group met the case minimum should be included in calculating the cost performance category score. Likewise, a few commenters recommended that similar to the quality performance category, scores for cost measures should not be below 3 out of 10 points. One commenter recommended that a cost performance category score not be calculated if a clinician or group only meets the case minimum for a single cost measure. Response: We do not believe that the inclusion of new measures in the cost performance category necessitates a change in the determination of the cost performance category score. Measures in the cost performance category differ from quality measures because they do not require reporting on the part of the clinicians outside of the usual claims submission process. Therefore, there is no choice of measures for clinicians nor burden of reporting. We believe that this is an important consideration in maintaining a simpler scoring mechanism in the cost performance category and scoring all measures for which an individual or group meets the case minimum. Some groups due to their size and comprehensiveness will meet the case minimum for all cost measures. Other individuals and groups will meet the case minimum for fewer measures. A scoring policy that would only score the top 6 measures in the cost performance category would provide an advantage for those groups with more than 6 measures because it would disregard those measures on which PO 00000 Frm 00022 Fmt 4701 Sfmt 4700 performance was poorest. For example, a group that met the case minimum for 10 measures and scored in the lowest decile for the total per capita cost score and the highest decile for all other measures, would have the score for the total per capita measure dropped and would receive the highest possible score in the cost performance category. A group that met the case minimum for only 6 measures, and also performed in the lowest decile for the total per capita cost score and the highest decile for the other 5 cost measures for which it met the case minimum, would not have performance on this measure disregarded and receive a lower score. We believe that not scoring clinicians and groups that meet the case minimum for only a single measure would fail to recognize that a single measure, such as total per capita cost, could reflect care provided to a large number of patients. After consideration of the public comments, we are finalizing as proposed our proposal to revise § 414.1380(b)(2)(iv)(E) to provide that the maximum cost improvement score for the 2020, 2021, 2022, and 2023 MIPS payment years is zero percentage points. We are also finalizing as proposed our proposal at § 414.1380(a)(1)(ii) to modify the performance standards to reflect that the cost performance category percent score will not take into account improvement until the 2024 MIPS payment year. (d) Facility-Based Measures Scoring Option for the 2021 MIPS Payment Year for the Quality and Cost Performance Categories (i) Background In the CY 2018 Quality Payment Program final rule, we established a facility-based measurement scoring option for clinicians that meet certain criteria beginning with the 2019 MIPS performance period/2021 MIPS payment year (82 FR 53752 through 53767). We originally proposed a facility-based measurement scoring option for the 2018 MIPS performance period. We did not finalize the policy because we were concerned that we would not have the operational ability to inform clinicians early enough in the 2018 MIPS performance period to allow them to consider the consequences and benefits of participation (82 FR 53755). (ii) Facility-Based Measurement Applicability (A) General In the CY 2018 Quality Payment Program final rule, we limited facilitybased reporting to the inpatient hospital in the first year for several reasons, E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations amozie on DSK3GDR082PROD with RULES3 including because a more diverse group of clinicians (and specialty types) provide services in an inpatient setting than in other settings, and because the Hospital Value-Based Purchasing (VBP) Program adjusts payment to hospitals for inpatient services in connection with their performance under that program (82 FR 53753 through 53755). We also limited measures applicable for facilitybased measurement to those used in the Hospital VBP Program because the Hospital VBP Program compares hospital performance on a series of different measures intended to capture the breadth of inpatient care in the facility (82 FR 53753). We noted that we were open to the consideration of additional facility types in the future but recognized that adding a facility type would be dependent upon whether CMS has established a value-based purchasing program for that facility type, the applicability of measures, and our ability to appropriately attribute a clinician to a facility (82 FR 53754). Please note that when we use the term value-based purchasing, we are referring in general to value-based purchasing programs or scores, and not specifically the Hospital VBP Program, unless specifically stated. We did not propose to add additional facility types for facility-based measurement, but we are interested in potentially expanding to other settings in future rulemaking. Therefore, in section III.I.3.i.(1)(d)(vii) of this final rule, we outline several issues on which we requested feedback and would need to be resolved in order to expand this option to a wider group of facility-based clinicians in future years. (B) Facility-Based Measurement by Individual Clinicians In the CY 2018 Quality Payment Program final rule, we established individual eligibility criteria for facilitybased measurement at § 414.1380(e)(2)(i). We established that a MIPS eligible clinician who furnishes 75 percent or more of his or her covered professional services in sites of service identified by the POS codes used in the HIPAA standard transaction as an inpatient hospital or emergency room based on claims for a period prior to the performance period as specified by CMS (82 FR 53756 through 53757) is eligible as an individual for facility-based measurement. We had noted, as a part of our proposal summary, that we would use the definition of professional services in section 1848(k)(3)(A) of the Act in applying this standard (82 FR 53756). For purposes of determining eligibility for facility-based measurement, we discussed CMS using VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 data from the period between September 1 of the calendar year, 2 years preceding the MIPS performance period, through August 31 of the calendar year preceding the MIPS performance period, with a 30-day claims run out but did not finalize that as part of the applicable regulation (82 FR 53756 through 53757). Because we are using the quality measures associated with the inpatient hospital to determine the MIPS quality and cost performance category score, we wanted to ensure that eligible clinicians contributed to care in that setting during that time period. We indicated that CMS will use POS code 21 (inpatient) and POS code 23 (emergency department) for this purpose (82 FR 53756). Commenters on our proposal (as summarized in the CY 2018 Quality Payment Program final rule (82 FR 53756 through 53757)) expressed concern that adopting the definition that we did for facility-based clinicians would limit the number of clinicians who would be eligible. In the CY 2019 PFS proposed rule, we proposed to modify our determination of a facility-based individual at § 414.1380(e)(2)(i) in four ways (83 FR 35957). First, we proposed to add oncampus outpatient hospital (as identified in the POS code in the HIPAA standard transaction, that is, POS code 22) to the settings that determine whether a clinician is facility-based. Second, we proposed that a clinician must have at least a single service billed with the POS code used for the inpatient hospital or emergency room. Third, we proposed that, if we are unable to identify a facility with a value-based purchasing score to attribute as a clinician’s performance, that clinician is not eligible for facilitybased measurement. Fourth, we proposed to align the time period for determining eligibility for facility-based measurement with changes to the dates used to determine MIPS eligibility and special status detailed in section III.I.3.b. of this final rule. We explain these four proposals from the proposed rule in this section. In the CY 2019 PFS proposed rule, we stated our belief that these proposals will further expand the opportunity for facility-based measurement and eliminate issues associated with the provision of observation services while still restricting eligibility to those who work in an inpatient setting. First, we proposed to add the oncampus outpatient hospital (POS code 22) to the list of sites of service used to determine eligibility for facility-based measurement (83 FR 35957). We agree with commenters that limiting the eligibility to our current definition may PO 00000 Frm 00023 Fmt 4701 Sfmt 4700 59857 prevent some clinicians who are largely hospital-based from being eligible. However, expanding eligibility without taking into account the relationship between the clinician and the facility and facility’s performance could result in unfairly attributing to a clinician performance for which the clinician is not responsible or has little to no role in improving. We do believe that a significant provision of services in the on-campus outpatient hospital are reflected in the quality captured by the Hospital VBP Program. For example, patients in observation status are typically treated by the same staff and clinicians as those who meet the requirements for inpatient status. Although there are some clinical differences that may result in a patient having observation status, we believe that the quality of care provided to these patients in this same setting would be comparable, reflecting the overall healthcare system at that particular location. In the CY 2019 PFS proposed rule, we stated our conviction, based on this that a sufficient nexus exists for attributing the hospital’s VBP Total Performance Score to clinicians that provide services in on-campus outpatient hospital settings. Second, we proposed to require that clinicians bill at least a single service with the POS codes for inpatient hospital or the emergency room in order to be eligible for facility-based measurement (83 FR 35957). Although we generally believe that clinicians who provide services in the outpatient hospital can affect the quality of care for inpatients, we noted in the CY 2019 PFS proposed rule our belief that a clinician who is measured according to the performance of a hospital should at least have a minimal presence in the inpatient or emergency room setting. We explained our concern about attributing inpatient facility performance to clinicians who provide at least 75 percent of their services at on-campus outpatient hospitals (with POS code 22) when such clinicians exclusively provide outpatient services that are unrelated to inpatient hospital service by describing an example: A dermatologist who provides office-based services in a hospital-owned clinic but who never admits or treats patients within the inpatient or emergency room setting does not meaningfully contribute to the quality of care for patients measured under the Hospital VBP Program. We stated in the CY 2019 PFS proposed rule how we had considered different ways to best identify those who contribute to the quality of care in the inpatient setting while keeping the E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59858 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations facility-based scoring option as simple as possible. We provided one explanation of an alternative we had considered: Separately measuring the HCPCS codes for observation services; however, as also noted in the proposed rule, we believe that such a measurement may not fairly consider services provided by clinicians for whom observations services may be embedded in a global code for a procedure rather than billed as a separate observation service. We also considered requiring a clinician to provide a certain percentage of services with the inpatient hospital POS. We described how we had not identified a threshold (other the one claim threshold we proposed) that would more meaningfully differentiate clinicians who provide services with the outpatient hospital POS code versus those who do not contribute to the services that would be measured under the Hospital VBP Program. We identified our goal of ensuring that the program rules are clear and easily applied to clinicians, so as to both avoid confusion on program participation requirements and to meet overall agency goals to increase transparency in the agency’s activities. Our proposal of using a single service as the threshold would provide a simple, bright-line to differentiate those who never provide inpatient services from clinicians that do provide inpatient services as well as outpatient services. We explained in the proposed rule that this would limit the chance of clinicians who exclusively practice in the outpatient setting being measured on the Hospital VBP Program’s performance of an unrelated hospital. We recognized this requirement of one service with the inpatient or emergency department POS may not demonstrate a significant presence in a particular facility and solicited comment on whether a better threshold could be used to identify those who are contributing to the quality of care for patients in the inpatient setting without creating unnecessary or inappropriate barriers to eligibility for facility-based measurement. We explained in the proposed rule our rationale and reasoning for these first two proposals as being based in large part on our analysis of the previously finalized policy for eligibility for the facility-based measurement scoring option. Using claims data, we had identified all clinicians that would be MIPS eligible as either an individual or group, and identified the POS codes submitted for PFS services provided by those clinicians. We then modeled the VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 existing final policy based on inpatient and ER services. Although almost all ER physicians would be scored under facility-based measurement, a relatively small percentage of clinicians in other specialties, even those which we expected to have significant presence in the hospital, would be eligible for the facility-based measurement scoring option. For example, only 13.45 percent of anesthesiologists would be eligible for the facility-based measurement scoring option under the policy finalized in the CY 2018 Quality Payment Program final rule. Adding the on-campus outpatient hospital POS code substantially increased eligibility for the facility-based measurement scoring option in our modeling, even after we adjusted for requiring one service with the inpatient or emergency department POS. Under our proposal, our model illustrated that 72.55 percent of anesthesiologists would be eligible. However, the model did not show that the proposal would substantially increase the number of clinicians eligible for the facility-based measurement scoring option who, based on specialty identification, may not have a significant presence in the hospital. For example, the modeling of the proposed policy projected an increase in the percentage of family physicians eligible for the facility-based measurement scoring option from 11.34 percent to 13.86 percent, which is still a very small percentage of those clinicians. Third, we proposed to add a new criterion (to be codified at § 414.1380(e)(2)(i)(C)) that stated to be eligible for facility-based measurement, we must be able to attribute a clinician to a particular facility that has a valuebased purchasing score (83 FR 35957 through 35958). We explained in the proposed rule how, for facility-based measurement to be applicable, we must be able to attribute a clinician to a facility with a value-based purchasing score. Based on our definition of facility-based measurement, we stated that this means a clinician must be associated with a hospital with a Hospital VBP Program Total Performance Score. We explained our concern that the proposed expansion of eligibility for facility-based measurement would increase the number of clinicians eligible for facilitybased measurement but to whom we would be unable to attribute the performance of a particular facility that has a value-based purchasing score. As we noted in the CY 2018 Quality Payment Program final rule (82 FR 53766), some hospitals do not have a PO 00000 Frm 00024 Fmt 4701 Sfmt 4700 Hospital VBP Program Total Performance Score that could be used to determine a MIPS quality and cost performance category score, such as hospitals in the state of Maryland. Hence, clinicians associated with those hospitals would not be able to use facility-based measurement but could report quality measures through another method and have cost measures calculated if applicable. We explained that, under our proposal, a similar result, although relatively rare, would happen if we could not attribute a clinician identified as facility-based to a specific facility; those clinicians who are identified as facility-based but whom we cannot attribute to a hospital would have to participate in MIPS quality reporting through another method, or they would receive a score of zero in the quality performance category. Therefore, we proposed to add the requirement to § 414.1380(e)(2)(i)(C) that a clinician must be able to be attributed to a particular facility with a value-based purchasing score under the methodology specified in § 414.1380(e)(5) to be eligible for facility-based measurement. The crossreference to paragraph (e)(5) is to the methodology we also proposed for determining the applicable facility score to be used. Our proposed new regulatory text at § 414.1380(e)(2)(i)(C) addresses both attribution to a facility and the need for that facility to have a value-based purchasing score by conditioning eligibility for facility-based scoring for an individual clinician on the clinician being attributed under the methodology in paragraph (e)(5) to a facility with a value-based purchasing score. Fourth, we proposed to change the dates of determining eligibility for facility-based measurement (83 FR 35958). In section III.M.3.b. of the proposed rule, we proposed to modify the dates of the MIPS determination period that would provide eligibility determination for small practice size, non-patient facing, low-volume threshold, ASC, hospital-based, and facility-based determination periods. To align this regulation controlling facilitybased scoring with these other determination periods, we proposed that CMS would use data from the initial 12-month segment beginning on October 1 of the calendar year 2 years prior to the applicable performance period and ending on September 30 of the calendar year preceding the applicable performance period, with a 30-day claims run out, in determining eligibility for facility-based measurement. E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations The following is a summary of the public comments received on these proposals and our responses: Comment: Many commenters supported the four proposed changes to the determination of a facility-based individual. Response: We appreciate the commenters’ support. Comment: One commenter recommended that CMS include the place of service code used for the offcampus outpatient hospital (POS code 19) in determining individual eligibility for facility-based measurement, noting that many clinicians work in both oncampus and off-campus outpatient hospital settings. The commenter further suggested the inclusion of the measures from the Hospital Outpatient Quality Reporting Program. Response: While we are finalizing our proposal to add on the on-campus outpatient code (POS code 22), we disagree that the off-campus outpatient hospital setting (POS code 19) indicates that a clinician has a significant impact on the quality and cost within an inpatient hospital setting in the way that POS code 22 might. A clinician may work at an off-campus outpatient hospital setting that is miles from the hospital and not have any involvement with patients that are hospitalized. We do not believe the Hospital VBP Program measures, which reflect the quality of care furnished to patients in hospitals in inpatient settings, are applicable to (or relate to the performance of) those clinicians who primarily bill within the off-campus outpatient hospital setting; therefore, we do not believe such clinicians should be eligible for facility-based measurement. While the measures used in the Hospital Outpatient Quality Reporting Program do reflect quality for the offcampus outpatient hospital, section 1848(q)(2)(C)(ii) of the Act provides that we may not use measures for hospital outpatient departments, except in the case of items and services furnished by emergency physicians, radiologists, and anesthesiologists. Our determination of facility-based measurement does not consider the specialty of clinicians, so we therefore do not believe it is appropriate or consistent with the statutory authority to add this setting or these measures at this time. Comment: One commenter recommended that the threshold of services required to be provided in facilities to be eligible for facility-based measurement be reduced from 75 percent to more than 50 percent of services, because clinicians often work in multiple settings. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 Response: As we stated in the CY 2018 Quality Payment Program final rule (82 FR 53757), we believe the 75 percent threshold is appropriate to use because it is similar to our determination of hospital-based eligible clinicians in the Promoting Interoperability performance category. In the context of our proposal to change the eligibility criteria for facility-based measurement, we still believe that a 75 percent threshold indicates that a clinician is spending much of their clinical time working in a hospital and the quality of their work is reflected in that setting. Clinicians who work in more varied settings may be better measured through another method of participating in MIPS. Comment: One commenter recommended that CMS not include the requirement to bill at least a single service with the POS code used for the inpatient hospital or emergency room as this requirement could easily be gamed. Response: We continue to believe that that using a single service as the threshold provides a simple, bright line to differentiate those who never provide inpatient services from clinicians that do provide inpatient services, as well as outpatient services. We will monitor this requirement and may consider changing it in future rulemaking if we find evidence or examples of gaming, such as that clinicians are providing services in the inpatient setting primarily so they may meet the requirements of facility-based measurement. Comment: Several commenters supported the facility-based measurement and the proposed policies because this option would reduce burden and recognize the joint accountability for measures in the hospital environment. Response: We appreciate the commenters’ support as we begin to implement facility-based measurement in the 2019 MIPS performance period/ 2021 MIPS payment year. Comment: Several commenters requested that CMS provide more data analysis on the implementation of facility-based measurement. A few commenters noted concerns with how the facility-based scoring option could contribute to an uneven playing field. Commenters’ concerns highlighted that automatically applying a quality and cost score eliminates incentives to coordinate care which may place these clinicians at an unfair advantage over those who must report on measures and take steps to perform well on those measures. Hence, commenters encouraged CMS to closely monitor the impact of the facility-based scoring PO 00000 Frm 00025 Fmt 4701 Sfmt 4700 59859 option policy. One commenter suggested that CMS provide more data on how MIPS eligible clinicians might score in the facility-based scoring option. Another commenter suggested that CMS provide data on the percentage of certain specialists who would be eligible. A few commenters suggested that CMS should closely monitor how facility-based measurement impacts total MIPS scores between specialties and groups working within the same hospital, as well as the effect of facility-based measurement on those who are not eligible. One commenter suggested that CMS provide more information via educational resources; another commenter requested that CMS explain how the Hospital VBP Program Total Performance Score is converted into MIPS scoring and requirements for group reporting options. Response: We recognize the value of data analysis when developing additional scoring options for MIPS eligible clinicians. We continue to believe that the facility-based scoring option will reduce administrative burden by streamlining reporting and allowing clinicians to focus on quality improvement. We disagree that clinicians have an advantage under facility-based scoring option given that we have established an eligibility threshold to identify those clinicians that have a significant impact on the care delivered within the facility and the facility’s performance under the Hospital VBP Program. The scoring methodology developed for facilitybased measurement translates scores in the Hospital VBP Program to scores in the Quality and Cost performance category. Because that translation takes into account the distribution of scores in the Hospital VBP program, which is analogous to the distribution of scores in MIPS, clinicians who are scored using facility-based measurement will have a similar range of scores as those who are not eligible for facility-based measurement. We will continue to monitor the impact of the finalized facility-based scoring policies in efforts to avoid unfair advantages within the MIPS program. Comment: Several commenters expressed concern about the availability of facility-based measurement beginning in the 2019 MIPS performance period/ 2021 MIPS payment year. The commenters expressed concern that the measures included in the Hospital VBP Program were not representative of the care provided by clinicians and would distract from efforts to focus on measures on which these clinicians could have an effect. A few commenters E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59860 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations supported facility-based measurement as a short-term solution to reducing administrative burden for clinicians who primarily work within an inpatient setting but encouraged movement towards measures that are more meaningful for certain specialists who also predominantly work within an inpatient setting. Response: We recognize that the Hospital VBP Program was not designed to measure clinicians’ performance but rather hospitals’ performance. However, we believe that by using the established 75 percent threshold to identify clinicians as eligible for facility-based scoring, we are distinguishing between those clinicians who ultimately have a significant impact on the hospital’s performance score for the care and cost rendered within that facility versus those who do not. We therefore believe that the Hospital VBP Program measures do reflect the performance of the clinicians in a team-based environment. We note that there may be more opportunities for clinicians, particularly specialists who wish to report on more clinically meaningful measures, to participate in MIPS using qualified registries or QCDRs that may be related to care provided to those specific patients in a facility setting, and we encourage clinicians who find the MIPS measures more meaningful in the context of their patient population to report in that manner. After consideration of the public comments, we are finalizing our proposals to add the on-campus outpatient hospital (POS code 22) to the list of sites of service used to determine eligibility for facility-based measurement and to require that clinicians bill at least a single service with the POS codes for inpatient hospital or the emergency room in order to be eligible for facility-based measurement as reflected in the regulation text at § 414.1380(e)(2)(i)(A) and (B). We are also finalizing our proposal that we must be able to attribute a clinician to a particular facility that has a value-based purchasing score under the methodology specified in § 414.1380(e)(5) to meet eligibility for facility-based measurement as codified at § 414.1380(e)(2)(i)(C). We are also finalizing our proposed policy that CMS would use data from the initial 12month segment beginning on October 1 of the calendar year 2 years prior to the applicable performance period and ending on September 30 of the calendar year preceding the applicable performance period, with a 30-day claims run out to determine eligibility for facility-based measurement. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 (C) Facility-Based Measurement by Group In the CY 2018 Quality Payment Program final rule (82 FR 53757), we finalized at § 414.1380(e)(2)(ii) that a MIPS eligible clinician is eligible for facility-based measurement under MIPS if they are determined to be facilitybased as part of a group. We established at § 414.1380(e)(2)(ii) that a facilitybased group is a group in which 75 percent or more of its eligible clinician NPIs billing under the group’s TIN meet the requirements at § 414.1380(e)(2)(i) (82 FR 53758). We did not propose any changes to the determination of a facility-based group but acknowledged that our proposal to change how individual clinicians are determined to be eligible for facility-based measurement will necessarily have a practical impact for practice groups. For more of the statutory background and descriptions of our current policies on determining a facility-based group, we refer readers to the CY 2018 Quality Payment Program final rule (82 FR 53757 through 53758). (iii) Facility Attribution for FacilityBased Measurement In the CY 2018 Quality Payment Program final rule (82 FR 53759), we finalized at § 414.1380(e)(5) a method to identify the hospital whose scores would be associated with a MIPS eligible clinician or group for purposes of facility-based measurement scoring. However, because of a discrepancy in the preamble and the proposed regulation text in the CY 2018 Quality Payment Program proposed rule (82 FR 53759), we indicated we would address this issue as part of the next Quality Payment Program rulemaking cycle. Under the current regulation text § 414.1380(e)(5), a facility-based clinician or group receives a score under the facility-based measurement scoring standard derived from the value-based purchasing score for the facility at which the clinician or group provided services to the most Medicare beneficiaries during the year claims are drawn (that is, the 12-month period described in paragraph (e)(2)). Although we did not propose any changes, we are revising this section to replace the word ‘‘segment’’ with ‘‘period’’ for clarity purposes. If an equal number of Medicare beneficiaries are treated at more than one facility, then we will use the valuebased purchasing score for the highestscoring facility (82 FR 53759 through 53760). For more of the statutory background and descriptions of our current policies for attributing a facility PO 00000 Frm 00026 Fmt 4701 Sfmt 4700 to a MIPS eligible clinician, we refer readers to the CY 2018 Quality Payment Program final rule (82 FR 53759 through 53760). In considering the issue of facility attribution for a facility-based group, we stated in the CY 2019 PFS proposed rule that we believe that a change to facilitybased attribution is appropriate to better align the policy with the determination of a facility-based group at § 414.1380(e)(2)(ii). A facility-based group is one in which 75 percent or more of the eligible clinician NPIs billing under the group’s TIN are eligible for facility-based measurement as individuals. Additionally, under the current regulation, the value-based purchasing score for the highest scoring facility would be used in the case of a tie among the number of facilities at which the group provided services to Medicare beneficiaries. We proposed to revise § 414.1380(e)(5) to differentiate how a facility-based clinician or group receives a score based on whether they participate as a clinician or a group (83 FR 35958). We proposed to remove ‘‘or group’’ from § 414.1380(e)(5) and redesignate that paragraph as (e)(5)(i) so that it only applies to individual MIPS eligible clinicians (83 FR 35958). Under our proposal, newly redesignated paragraph (e)(5)(i) would retain the rule for facility attribution for an individual MIPS eligible clinician as finalized in the CY 2018 Quality Payment Program final rule; we also proposed a few minor edits to the paragraph for grammar and to improve the sentence flow. We also proposed to add a new paragraph (e)(5)(ii) to provide that a facility-based group receives a score under the facilitybased measurement scoring standard derived from the value-based purchasing score for the facility at which the plurality of clinicians identified as facility-based would have had their score determined under the methodology described in § 414.1380(e)(5)(i) if the clinicians had been scored under facility-based measurement as individuals (83 FR 35958). We made this proposal because of our wish to emphasize the connection between an individual clinician and a facility. We explained in the CY 2019 PFS proposed rule that using the plurality of clinicians reinforces the connection between an individual clinician and facility and is more easily understandable for larger groups. The following is a summary of the public comments received on these proposals and our responses: Comment: A few commenters suggested that CMS consider additional rules or standards for attribution of a E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations clinician or group to a facility for purposes of using that facility’s Total Performance Score. One commenter requested that CMS consider using an eligible clinician’s/group’s second most utilized facility in cases where the top utilized facility does not have a Hospital VBP Program Total Performance Score. Another commenter encouraged CMS develop a group level attribution methodology to account for groups that practice in multiple sites and the commenter believed that an accountability model will be more meaningful and actionable for these groups. Response: We are finalizing our proposal that if we are unable to identify a particular facility with a value-based purchasing score under the methodology specified in § 414.1380(e)(5), such as those facilities in the state of Maryland, to attribute for use as an individual clinician’s performance, then that clinician is not eligible for facility-based measurement. We are concerned that using a hospital other than the most utilized could result in assigning a score based on a hospital at which the clinician rarely works. For example, in the case of using the second most utilized facility, an individual clinician may have primarily worked in the facility without a Hospital VBP Program Total Performance Score and then only have seen a single patient at the second most utilized hospital with a Hospital VBP Total Performance Score. However, we will consider looking into this issue in future rulemaking, including whether it may be appropriate to allow for the score to be based upon a facility other than the one at which a clinician provides services to the most patients. We understand that some groups that may be facility-based include clinicians that practice in a number of different facilities. However, we believe this issue is similar to that experienced in other clinician groups that may have a diversity of clinicians and settings. In section III.I.3.e of the proposed rule (83 FR 35891), we requested comments on developing an opportunity for clinicians to participate in MIPS as subgroups. We believe that our consideration of that issue could inform the determination of members of a group that practice in a single TIN but who serve patients in many different facilities. After consideration of the public comments, we are finalizing our proposals to remove ‘‘or group’’ from § 414.1380(e)(5); redesignate that paragraph as (e)(5)(i) so that it only applies to individual MIPS eligible clinicians; and add a new paragraph (e)(5)(ii) to § 414.1380(e)(5) regarding VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 group scoring methodologies in which a facility-based group receives a score under the facility-based measurement scoring standard derived from the valuebased purchasing score for the facility at which the plurality of clinicians identified as facility-based would have had their score determined under the methodology described in § 414.1380(e)(5)(i) if the clinicians had been scored under facility-based measurement as individuals. (iv) No Election of Facility-Based Measurement In the CY 2018 Quality Payment Program final rule (82 FR 53760), we did not finalize our proposal for how individual MIPS eligible clinicians or groups who wish to have their quality and cost performance category scores determined based on a facility’s performance would elect to do so through an attestation. We did finalize, and reflect in the introductory text at § 414.1380(e), that an individual clinician or group would elect to use a facility-based score. In the CY 2019 PFS proposed rule (82 FR 53760), we specified that such clinicians or groups would be required to submit their election during the data submission period through the attestation submission mechanism established for the improvement activities and the Promoting Interoperability performance categories. An alternative approach, which likewise was not finalized, did not require an election process, but instead would have automatically applied a facility-based measurement to MIPS eligible clinicians and groups who met the eligibility criteria for facilitybased measurement, if such an application were technically feasible (82 FR 53760). We noted in the CY 2018 Quality Payment Program final rule (82 FR 53760) that we would examine both the attestation process and the opt-out process, and work with stakeholders to identify a new proposal in future rulemaking. We explained in the CY2018 Quality Payment Program final rule (82 FR 53760) our interest in a process that would impose less burden on clinicians than an attestation requirement and requested comment on automatically assigning a clinician or group a facility-based score, but with a notice and opportunity to opt-out of facility-based measurement. We summarized those comments in the CY 2019 PFS proposed rule (83 FR 35958). After further considering the advantages and disadvantages of an optin or an opt-out process, we proposed a modified policy that would not require an election process. We proposed to automatically apply facility-based PO 00000 Frm 00027 Fmt 4701 Sfmt 4700 59861 measurement to MIPS eligible clinicians and groups who are eligible for facilitybased measurement and who would benefit by having a higher combined quality and cost performance category score (83 FR 35959). Under our proposal, if the MIPS eligible clinician or group is eligible for facility-based measurement, we would calculate a combined quality and cost performance category score. We proposed to use the facility-based score to determine the MIPS quality and cost performance category scores, unless we received another submission of quality data for or on behalf of that clinician or group and the combined quality and cost performance category score for the other submission results in a higher combined quality and cost performance score. If the other submission has a higher combined quality and cost performance score, then we would not apply the facility-based performance scores for either the quality or cost performance categories (83 FR 35959). Under our proposal, the combined score for the quality and cost performance categories would determine the scores to be used for both the quality and cost performance categories, for both individual clinicians and for groups that meet the requirements of paragraph (e)(2). We did not propose to adopt a formal opt-out process because, under our proposal, the higher of the combined quality and cost performance scores for the clinician or clinician group would be used, which would only benefit the clinician or group. We explained in the proposed rule our strong commitment to reducing burden as part of the Quality Payment Program and that we believe that requiring a clinician or group to elect a measurement process (or to opt-out of a measurement process) based on facility performance would add unnecessary burden. In MIPS, we score clinicians as individuals unless they submit data as a group. We stated in the proposed rule that the same policy should apply to facility-based measurement, even though there are no submission requirements for the quality performance category for individuals under facility-based measurement. We proposed to revise § 414.1380(e)(4) to state that there are no submission requirements for individual clinicians in facility-based measurement, but a group must submit data in the improvement activities or Promoting Interoperability performance categories in order to be measured as a group under facility-based measurement. We explained how, if a group does not E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59862 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations submit improvement activities or Promoting Interoperability measures, we would apply facility-based measurement to the individual clinicians and such clinicians would not be scored as a group under our proposal. In the case of virtual groups, MIPS eligible clinicians will have formed virtual groups prior to the MIPS performance period; as a result, virtual groups eligible for facility-based measurement will always be measured as a virtual group (83 FR 35959). Although we can calculate a score for a TIN without the submission of data by the TIN, we would not be certain if the clinicians in that group actually wanted to be measured as a group without an active submission (in other words, if the group did not submit data as a group). As we explained in the proposed rule, we view submission of data on the improvement activities or Promoting Interoperability measures as an indication by the clinicians in that group that they want to be scored as a group; using the choice to submit data as a group to identify a group in the context of facility-based scoring would preserve and respect choices made by clinicians and groups while avoiding the burden of an election process to be scored as a group solely for the purpose of facility-based scoring. We solicited comment specifically on this proposal and other means to achieve the same ends. In the CY 2018 Quality Payment Program final rule, we established that if a clinician or group elects facilitybased measurement but also submits MIPS quality data, then the clinician or group would be measured on the method that results in the higher quality score (82 FR 53767). We proposed to adopt this same scoring principle in conjunction with our proposal not to use (or require) an election process. Therefore, we proposed at § 414.1380(e)(6)(vi) that the MIPS quality and cost score for clinicians and groups eligible for facility-based measurement would be based on the facility-based measurement scoring methodology described in § 414.1380(e)(6) unless the clinician or group receives a higher combined score for the MIPS quality and cost performance categories through data submitted to CMS for MIPS (83 FR 35959). We stated in the proposed rule that this policy is not applicable to any MIPS eligible clinicians scored under the APM scoring standard described at § 414.1370; we further clarify here that this includes Shared Savings Program participant TINs in ACOs that have failed to complete web interface VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 reporting, unless these measures are specifically required under the terms of the applicable APM. We also proposed conforming changes in two other sections of regulatory text. We proposed to revise the introductory text at § 414.1380(e) to remove ‘‘elect to,’’ and therefore, reflect that clinicians and groups who are determined to be facility-based will receive MIPS quality and cost performance categories under the methodology in paragraph (e) (83 FR 35959 through 35960). Because of our proposal to not require clinicians to optin into facility-based measurement, we acknowledged that there may be clinicians that will continue to submit data via other methods. We explained that these clinicians and groups are not prohibited from submitting quality measures to CMS for purposes of MIPS. However, under our proposal, if a higher combined quality and cost score is achieved using data submitted to CMS for purposes of MIPS, then we will use the MIPS scores based on the submission. We also proposed to revise § 414.1380(e)(4) and (e)(6)(v)(A) to reflect that facility-based measurement does not require election and to replace the phrase ‘‘clinicians that elect facilitybased measurement’’ with ‘‘clinicians and groups scored under facility-based measurement’’ (83 FR 35960) as part of this policy. The following is a summary of the public comments received on these proposals and our responses: Comment: Many commenters supported our proposal to automatically apply facility-based measurement to MIPS eligible clinicians and groups who are eligible for facility-based measurement and who would benefit by having a higher combined quality and cost performance category score. Response: We thank the commenters for their support. Comment: A few commenters opposed our proposal to require a group to submit information in the improvement activities or Promoting Interoperability performance categories to be measured as a facility-based group. A few of these commenters requested that rather than requiring the submission of information in these categories, CMS offer an election process. One commenter questioned how a group that was excluded from both the improvement activities and Promoting Interoperability performance categories could participate as a facilitybased group. One commenter suggested that it would be difficult to complete an improvement activity if members of the group practice at more than one facility. Response: We continue to believe that our proposal of a clinician receiving the PO 00000 Frm 00028 Fmt 4701 Sfmt 4700 higher of the quality and cost performance score available would only benefit the individual MIPS eligible clinician or group. If we do not require groups to submit data in the improvement activity or Promoting Interoperability performance categories, then we will be unable to tell whether the clinician should be measured as part of a group. We will consider whether there would be an opportunity for a facility-based group to elect to participate without submitting data on another performance category in the future as feasible. We do not believe that we would need to establish additional policies for groups that would have their improvement activities performance score re-weighted specifically because we generally expect reweighting to occur for the improvement activities performance category only in rare cases of extreme and uncontrollable events. We do note that the clinicians in a facility-based group who meet the requirements for facility-based measurement as individuals will have scores in the quality and cost performance categories determined for them as individuals if there is no data submission from the group in the improvement activity or Promoting Interoperability performance categories. Comment: Commenters encouraged CMS to provide as much information as possible to eligible clinicians including information on eligibility for facilitybased measurement, clinician type, potential performance score under facility-based scoring, and to which facility the eligible clinician will be attributed. Several commenters noted that more information would give clinicians the opportunity to assess the advantages and disadvantages of various reporting options under MIPS. One commenter stated that more information will avoid confusion as to how the facility-based scoring option will work during the performance period. A few commenters noted concerns with the timing of receiving information about facility-based measurement. Some commenters noted the risk of a clinician assuming that he or she will meet the criteria for facility-based measurement when that may not be the case. Another commenter noted that the timing is important in making decisions as to whether to report as a group or an individual under the facility-based scoring option. Response: We intend to provide as much information as possible as early as possible to clinicians about their eligibility and the hospital performance upon which a MIPS eligible clinician’s score would be based. We acknowledge E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations that clinicians may want to consider this information to make financial and operational decisions, regardless of not having to be required to opt-in to facility-based scoring. We intend to provide additional information to clinicians regarding their status with facility-based measurement eligibility, facility attribution, and a preview score based on data from the previous performance period. We anticipate that this information will be released during the first quarter of the performance period, if technically feasible, beginning with the 2019 performance period, and we aim to notify clinicians as soon as this information is available. Comment: Many commenters expressed concern with our proposal to not require an opt-in or offer an opt-out for facility-based measurement. A few commenters noted that performing this calculation automatically would reduce the control that clinicians have over their participation in MIPS. A few commenters suggested that automatically calculating a score for facility-based clinicians would reduce the incentive to participate in clinical data registries. A few commenters suggested that not requiring an opt-in would provide a performance advantage to facility-based clinicians over those who are not eligible for facility-based measurement. One commenter expressed concern that clinicians could have measures displayed on Physician Compare from facility-based measurement. Response: Receiving the higher of the combined quality and cost performance scores available would only benefit the applicable individual MIPS eligible clinician or group; however, we are uncertain that facility-based clinicians would necessarily perform better than those who submit MIPS data, because the opportunity to submit data via other methods provides individual clinicians or groups the opportunity to select quality measures. We continue to believe that adding a formal opt-in or opt-out process would add unnecessary burden for both individual clinicians and groups. Additionally, we believe that those MIPS eligible clinicians who will not be required to submit MIPS data will benefit from a reduction in administrative burden while being measured in a facility in which their care has a significant impact on the facility’s performance. We note that clinicians who wish to better control their performance in MIPS may submit measures through another method. Hence, we are finalizing our proposal to not require an opt-in or opt-out for facility-based measurement. Additionally, we did not propose any VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 policies for how facility-based measures, other than the scores derived from those measures and included as quality and cost performance category scores, will be displayed on Physician Compare, but we thank commenters for their input and will take this input into consideration in future years. Comment: One commenter requested clarification on how CMS would score a facility-based clinician who submits data on the quality performance category but does not have a cost performance category score, and thus, the cost performance category weight would need to be redistributed to the quality performance category. Response: The cost performance category can be reweighted to 0 percent if there are not sufficient cost measures applicable and available (for example, if the clinician does not meet the minimum case requirements for the cost measures). In cases in which a clinician or group does not have a score in the cost performance category, in general, the weight of the cost performance category would be redistributed to the quality performance category. In that case, the points assigned under § 414.1380(b) for purposes of calculating/assigning the MIPS final score in the cost and quality categories will be compared to the points that contribute to the final score from the quality and cost scores established under facility-based measurement. For example, a clinician whose data was submitted on their behalf by a thirdparty intermediary and received a MIPS quality performance category percent score of 50 percent but did not meet the case minimum for cost measures, would have a total of 30 points as the combined score for the quality and cost performance categories. If that same clinician were eligible for facility-based measurement, the score based on that third party intermediary submission would be used unless the combination of the quality and cost scores established under facility-based measurement (as calculated under § 414.1380(e)(6)) resulted in more than 30 points towards the final score. Comment: One commenter requested guidance and language as to how to account for MIPS eligible clinicians who wish to use their facility’s Hospital VBP Program Total Performance Score for the quality and cost performance categories, yet still use a QCDR to report. Response: Our proposed policy to not require an opt-in or offer an opt-out for facility-based measurement anticipates that there may be some clinicians and groups who will both receive a score based upon facility-based measurement and submit quality measures via various PO 00000 Frm 00029 Fmt 4701 Sfmt 4700 59863 collection types. These clinicians may believe these quality measures better represent their performance or that they will perform better submitting these measures. In all cases, under the policy we are finalizing here, we will compare combined performance in these two categories and assign the clinician or group the higher combined score, whether based on the facility-based measurement or through another submission type. We note that facilitybased measurement only applies to the quality and cost performance categories; the Promoting Interoperability and improvement activity performance categories would still require reporting on the part of the clinicians or group. After consideration of the public comments, we are finalizing our proposal to automatically apply facilitybased measurement to MIPS eligible clinicians and groups who are eligible for facility-based measurement and those who have a higher combined quality and cost performance category score. Additionally, we are finalizing our proposal to revise § 414.1380(e)(4) to state that there are no submission requirements for individual clinicians in facility-based measurement and that a group must submit data in the improvement activities or Promoting Interoperability performance categories to be measured as a group under facility-based measurement. Additionally, we are also revising the proposed regulation text for § 414.1380(e)(4) by adding ‘‘to be’’ between ‘‘clinicians’’ and ‘‘scored’’ to clarify that this paragraph is establishing the data submissions necessary for facility-based scoring to be possible as opposed to a provision governing MIPS reporting as a whole for all categories. We are also finalizing the conforming changes at § 414.1380(e)(4) and (e)(6) to revise text that referred to an election by the clinician or group to use facility-based scoring. Additionally, while we did not propose any changes, we are revising § 414.1380(e) to state, for the payment in 2021 MIPS payment year and subsequent years and subject to paragraph (e)(6)(vi) of this section, a MIPS eligible clinician or group will be scored under the quality and cost performance categories under the methodology described in this paragraph (e). These technical changes are made to conform to our policy in this section to not require or offer an election and to improve readability. (v) Facility-Based Measures (A) Background Section 1848(q)(2)(C)(ii) of the Act provides that the Secretary may use E:\FR\FM\23NOR3.SGM 23NOR3 59864 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations amozie on DSK3GDR082PROD with RULES3 measures used for payment systems other than for physicians, such as measures for inpatient hospitals, for purposes of the quality and cost performance categories. However, the Secretary may not use measures for hospital outpatient departments, except in the case of items and services furnished by emergency physicians, radiologists, and anesthesiologists. In the CY 2018 Quality Payment Program proposed rule, we proposed to include for the 2020 MIPS payment year all the measures adopted for the FY 2019 Hospital VBP Program on the MIPS list of quality measures and cost measures for purposes of facility-based measurement (82 FR 30125). We noted how these measures meet the definition of additional system-based measures provided in section 1848(q)(2)(C)(ii) of the Act (82 FR 30125). In the CY 2018 Quality Payment Program final rule, we did not finalize our proposal that the facility-based measures available for the 2018 MIPS performance period would be the measures adopted for the FY 2019 Hospital VBP Program; nor did we finalize our proposal that, for the 2020 MIPS payment year, facility-based individual MIPS eligible clinicians or groups that were attributed to a facility would be scored on all measures on which the facility is scored via the Hospital VBP Program’s Total Performance Score methodology (82 FR 53762). We did finalize a facility-based measurement scoring standard but not the specific instance of using the FY 2019 Hospital VBP Program Total Performance Score methodology (82 FR 53755). We expressed our belief that using all measures from the Hospital VBP Program is appropriate; nevertheless, because we did not finalize the facility-based measurement scoring option for the 2018 MIPS performance period/2020 MIPS payment year, it was not appropriate to adopt these policies at that time (82 FR 53762 through 53763). We noted that we intended to propose measures that would be available for facility-based measurement for the 2019 MIPS performance period/2021 MIPS payment year in future rulemaking (82 FR 53763). (B) Measures in Facility-Based Scoring As we noted in the proposed CY 2019 PFS rule, we continue to believe it is appropriate to adopt all the measures for the Hospital VBP Program into MIPS for purposes of facility-based scoring; these Hospital VBP Program measures meet the definition of additional systembased measures provided in section 1848(q)(2)(C)(ii) of the Act. We also VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 stated how it is appropriate to adopt the performance periods for the measures, which generally are consistent with the dates that we use to determine eligibility for facility-based measurement. Beginning with the 2019 MIPS performance period, we proposed at § 414.1380(e)(1)(i) to adopt for facilitybased measurement, the measure set that we finalize for the fiscal year Hospital VBP Program for which payment begins during the applicable MIPS performance period. For the 2019 MIPS performance period (which runs on the 2019 calendar year), we proposed to adopt the FY 2020 Hospital VBP Program measure set, for which payment begins on October 1, 2019. The performance period for these measures varies but performance ends in 2018 for all measures. We also proposed at § 414.1380(e)(1)(ii) that, starting with the 2021 MIPS payment year, the scoring methodology applicable for MIPS eligible clinicians scored with facility-based measurement is the Total Performance Score methodology adopted for the Hospital VBP Program, for the fiscal year for which payment begins during the applicable MIPS performance period. Additionally, we note a typographical error in the CY 2019 PFS proposed rule (83 FR 35960) in which we state FY 2019 instead of FY 2020, which we believe commenters have likely understood given the comments we have received on FY 2020 measures. However, we provide additional clarification in this final rule. We noted in the proposed rule that this approach of adopting all the measures in the Hospital VBP Program can be applied to other value-based purchasing programs in the future, should we decide to expand facilitybased measurement to settings other than hospitals. In the CY 2018 Quality Payment Program final rule we also established at § 414.1380(e)(6)(i) that the available quality and cost measures for facilitybased measurement are those adopted under the value-based purchasing program of the facility for the year specified. We established at § 414.1380(e)(6)(ii) that we will use the benchmarks adopted under the valuebased purchasing program of the facility program for the year specified (82 FR 53763 through 53764). We noted that we would determine the particular valuebased purchasing program to be used for facility-based measurement in future rulemaking but would routinely use the benchmarks associated with that program (82 FR 53764). Likewise, at § 414.1380(e)(6)(iii), we established that PO 00000 Frm 00030 Fmt 4701 Sfmt 4700 the performance period for facilitybased measurement is the performance period for the measures adopted under the value-based purchasing program of the facility program for the year specified (82 FR 53755). We noted that these provisions referred to the general parameters of our method of facilitybased measurement and that we would address specific programs and years in future rulemaking (82 FR 53763). For the CY 2019 performance period, we proposed regulation text for these three provisions to specify that the measures, performance period, and benchmark period for facility-based measurement are the measures, performance period, and benchmark period established for the value-based purchasing program used to determine the score as described in § 414.1380(e)(1) (83 FR 35960). We provided an example in the proposed rule to illustrate this policy: For the 2019 MIPS performance period and 2021 MIPS payment year, the measures used would be those for the FY 2019 Hospital VBP Program along with the associated benchmarks and performance periods. As explained earlier, we intended this to mean that for the 2019 MIPS performance period and 2021 MIPS payment year, the measures used would be those for the FY 2020 Hospital VBP Program along with the associated benchmarks and performance periods. The following is a summary of the public comments received on these proposals and our responses: Comment: Several commenters noted their appreciation of the facility-based scoring option but requested that CMS consider additional measures that are more relevant to specific specialties as that would capture clinically meaningful information. One commenter suggested CMS develop episode-based risk adjusted measures even if they are not used in the Hospital VBP Program. Another commenter suggested that CMS consider additional avenues to collect more meaningful information. Response: Section 1848(q)(2)(C)(ii) of the Act provides that the Secretary may use measures used for payment systems other than for physicians, such as measures for inpatient hospitals, for purposes of the quality and cost performance categories. Based on this statutory requirement and because we want to align incentives between clinicians and hospitals, we proposed to use measures that are developed and implemented in other programs, as opposed to new measures that reflect a facility’s performance. Due to this limitation, we note that there may be additional avenues for clinicians to participate in MIPS using qualified E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations amozie on DSK3GDR082PROD with RULES3 registries or QCDRs that measure quality for services that may be provided in a facility setting, such as inpatient surgeries, without being measured in facility-based measurement. After consideration of the public comments, we are finalizing the proposed regulation text at § 414.1380(e)(1)(i) that the measures for facility-based measurement will be the measure set finalized for the fiscal year value-based purchasing program for which payment begins during the applicable MIPS performance period. We are also finalizing the proposed regulation text at § 414.1380(e)(1)(ii) that, beginning with the 2021 MIPS payment year, the scoring methodology applicable for MIPS eligible clinicians scored with facility-based measurement is the Total Performance Score methodology adopted for the Hospital VBP Program for the fiscal year for which payment begins during the applicable MIPS performance period. This means that for the 2021 MIPS payment year, the Total Performance VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 Score for FY 2020 will be applied for the MIPS performance year 2019. Additionally, while we did not propose any changes, we are revising the regulation text at § 414.1380(e)(1)(i) to stated that the measures used for facility-based measurement are the measure set finalized for the fiscal year VBP program for which payment begins during the applicable MIPS performance period. This update is not intended to be substantive in nature, but rather to bring more clarity to the regulatory text. We have also made a technical revision in which we revise § 414.1380(e)(6)(ii), (iv), and (v) to reference only (e)(1) rather than (e)(1)(i) for improvements in readability and clarity of the regulation. (C) Measures for MIPS 2019 Performance Period/2021 MIPS Payment Year For informational purposes, we provided a list of measures included in the FY 2020 Hospital VBP Program that would be used in determining the quality and cost performance category PO 00000 Frm 00031 Fmt 4701 Sfmt 4700 59865 scores for the 2019 MIPS performance period/2021 MIPS payment year. The FY 2020 Hospital VBP Program has adopted 12 measures covering 4 domains (83 FR 20412 through 20413). The performance period for measures in the Hospital VBP Program varies depending on the measure, and some measures include multi-year performance periods. We noted in the proposed rule that these measures are determined through separate rulemaking (83 FR 38244); the applicable rulemaking is usually the Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System rule. We are using these measures, benchmarks, and performance periods for the purposes of facility-based measurement based on § 414.1380(e)(1) as finalized here. We repeat the list of measures finalized for the FY 2020 Hospital VBP measure set and Total Performance Score in Table 52. BILLING CODE 4120–01–P E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations BILLING CODE 4120–01–C (vi) Scoring Facility-Based Measurement amozie on DSK3GDR082PROD with RULES3 (A) Scoring Achievement in FacilityBased Measurement In the CY 2018 Quality Payment Program final rule, we adopted certain scoring policies for clinicians and groups in facility-based measurement. We established at § 414.1380(e)(6)(iv) and (v) that the quality and cost performance category percent scores would be established by determining the percentile performance of the facility in the value-based purchasing program for the specified year, then awarding scores associated with that same percentile performance in the MIPS quality and cost performance categories for those MIPS eligible clinicians who are not scored using facility-based measurement for the MIPS VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 payment year (82 FR 53764). We also finalized at § 414.1380(e)(6)(v)(A) that clinicians scored under facility-based measurement would not be scored on other cost measures (82 FR 53767). For detailed descriptions of the current policies related to scoring achievement in facility-based measurement, we refer readers to the CY 2018 Quality Payment Program final rule (82 FR 53763). Because we proposed to not require or allow an optin process for facility-based measurement, we proposed a change to the determination of the quality and cost performance category scores. We proposed that the quality and cost performance category percent scores would be established by determining the percentile performance of the facility in the Hospital VBP Program for the specified year, then awarding a PO 00000 Frm 00032 Fmt 4701 Sfmt 4700 score associated with that same percentile performance in the MIPS quality and cost performance categories for those MIPS eligible clinicians who are not eligible to be scored under facility-based measurement for the MIPS payment year (83 FR 35961). Under our proposal, the determination of percentile performance would be independent of those clinicians who would not have their quality or cost scores determined until we make the determination of their status under facility-based measurement. The following is a summary of the public comments received on these proposals and our responses: Comment: A few commenters supported our proposal that the quality and cost performance category percent scores for clinicians in facility-based measurement would be established by E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.068</GPH> 59866 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations determining the percentile performance of the facility in the Hospital VBP Program for the specified year, then awarding a score associated with that same percentile performance in the MIPS quality and cost performance categories for those MIPS eligible clinicians who are not eligible to be scored under facility-based measurement for the MIPS payment year. Response: We thank the commenters for their support. After consideration of the public comments, we are finalizing our proposal to change the determination of the quality and cost performance category scores at § 414.1380(e)(6)(iv) and (v) to establish both scores by determining the percentile performance of the facility in value-based purchasing program for the specified year, then awarding a score associated with that same percentile performance in the MIPS quality and cost performance categories for those MIPS eligible clinicians who are not eligible to be scored under facility-based measurement for the MIPS payment year. Also, we have revised the last sentence in paragraphs (e)(6)(iv) and (v) to more clearly state that a clinician or group receiving a facility-based performance score will not earn improvement points based on prior performance in the MIPS quality or cost categories. After further considering the issue, we stated in the CY 2019 PFS proposed rule our position that it is not possible to assess improvement in the quality performance category for those who are measured under facility-based measurement in 1 year and then through another method in the following year. Our method of assessing and rewarding improvement in the MIPS quality performance category separates points awarded for measure performance from those received for bonus points (82 FR 53745). Our method of determining the quality performance category score using facility-based measurement does not allow for the separation of achievement from bonus points. For this reason, we proposed at § 414.1380(b)(1)(vi)(A)(4) 30 to not assess improvement for MIPS-eligible clinicians who are scored in MIPS through facility-based measurement in 1 year but through another method in the following year (83 FR 39561). We did not receive any public comments on this proposal, so we will finalize our proposal to add regulatory text at § 414.1380(e)(6)(iv) and (v) and our proposal at § 414.1380(b)(1)(vi)(A)(4) to not assess improvement for MIPS-eligible clinicians who are scored in MIPS through facility-based measurement in 1 year but through another method in the following year. (B) Scoring Improvement in FacilityBased Measurement In the CY 2018 Quality Payment Program final rule, we finalized that we would not give a clinician or group participating in facility-based measurement the opportunity to earn improvement points based on prior performance in the MIPS quality and cost performance categories; we noted that the Hospital VBP Program already takes improvement into account in determining the Total Performance Score (82 FR 53764 through 53765). We proposed to add this previously finalized policy to regulatory text at § 414.1380(e)(6)(iv) and (v) (83 FR 35961). We did not address in the CY 2018 Quality Payment Program final rule a policy for a clinician or group who participates in facility-based measurement for one performance period, and then does not participate in facility-based measurement in a subsequent performance period (for example, a clinician who is scored using facility-based measurement in the 2019 MIPS performance period and is not eligible for facility-based measurement in the 2020 MIPS performance period). (vii) Expansion of Facility-Based Measurement To Use in Other Settings VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 We initiated the process of facilitybased measurement focusing on the inpatient hospital setting, but have noted in the past our policy goal of expanding the concept into other facilities and programs and future, in particular to use the post-acute care (PAC) and the end-stage renal disease (ESRD) settings as the basis for facilitybased measurement and scoring. In the proposed rule, we summarized a number of issues and topics related to the use of PAC and ESRD facilities (83 FR 35962 through 35963). We solicited comment on these topics, including: • How to attribute the quality and cost of care for patients in PAC settings to clinicians; • Whether using a value-based purchasing program, that is, a similar approach to § 414.1380(e)(1), could work for PAC given the number and variation of PAC settings and clinicians; 30 The codification was misidentified in the preamble of the proposed rule as § 414.1380(b)(1)(xi)(A)(4) but the regulation text was proposed, at 83 FR 36081, to be codified at § 414.1380(b)(1)(vi)(A)(4), where we are finalizing it. PO 00000 Frm 00033 Fmt 4701 Sfmt 4700 59867 • The level of influence MIPS-eligible clinicians have in determining performance on quality measures for individual settings and programs in the PAC setting; • Which PAC QRP measures may be best utilized to measure clinician performance; • Methods to identify the appropriate measures for scoring, and what measures would be most influenced by clinicians; • Whether all measures that are reported as part of the PAC QRPs should be included or whether we should identify a subset of measures; • Whether we should limit facilitybased measurement to specific PAC settings and programs such as the IRF QRP or LTCH QRP, or whether we should consider all PAC settings in the facility-based measurement discussion; • The extent to which the quality measures of dialysis centers reflect clinician performance; and • Practical and policy considerations related to whether we could to attribute the performance of a specific ESRD facility to an individual clinician. We appreciate the comments received in response to these considerations and may consider these suggestions in policies that will be proposed as part of future rulemaking. (e) Scoring the Improvement Activities Performance Category For our previously established policies regarding scoring the improvement activities performance category, we refer readers to § 414.1380(b)(3) and the CY 2018 Quality Payment Program final rule (82 FR 53767 through 53769). We also refer readers to § 414.1355 and the CY 2018 Quality Payment Program final rule (82 FR 53648 through 53662) and CY 2017 Quality Payment Program final rule (81 FR 77177 through 77199) for previously established policies regarding the improvement activities performance category generally. (i) Regulatory Text Updates In the CY 2019 PFS proposed rule, we proposed updates to both §§ 414.1380(b)(3) and 414.1355 to more clearly and concisely capture previously established policies (83 FR 35963). We also proposed one substantive change with respect to patient-centered medical homes and comparable specialty practices (83 FR 35963). These are discussed in more detail in this section. E:\FR\FM\23NOR3.SGM 23NOR3 59868 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations (A) Improvement Activities Performance Category Score and Total Required Points In an effort to more clearly and concisely capture previously established policies, we proposed updates to § 414.1380(b)(3) and refer readers to the CY 2019 PFS proposed rule for more details (83 FR 35963). We also clarified that the improvement activities performance category score cannot exceed 100 percent (83 FR 35963). We solicited comments on the above proposal. We did not receive any comments on this proposal. We are finalizing our changes to regulation text at § 414.1380(b)(3) as proposed. (B) Weighting of Improvement Activities In an effort to more clearly and concisely capture previously established policies, we proposed updates to § 414.1380(b)(3) and refer readers to the CY 2019 PFS proposed rule for more details (83 FR 35963). We solicited comments on the above proposal. We did not receive any comments on this proposal. We are finalizing our changes to regulation text at § 414.1380(b)(3) as proposed. amozie on DSK3GDR082PROD with RULES3 (C) APM Improvement Activities Performance Category Score In an effort to more clearly and concisely capture previously established policies, we proposed updates to § 414.1380(b)(3)(i) and refer readers to the CY 2019 PFS proposed rule for more details (83 FR 35963). We solicited comments on the above proposal. We did not receive any comments on this proposal. We are finalizing our changes to regulation text at § 414.1380(b)(3)(i) as proposed. (D) Patient-Centered Medical Homes and Comparable Specialty Practices In the CY 2019 PFS proposed rule (83 FR 35963), we proposed to modify our regulations at § 414.1380(b)(3)(ii) to more clearly and concisely capture our previously established policies for patient-centered medical homes and comparable specialty practices and refer readers to the CY 2019 PFS proposed rule for more details. In addition, it had come to our attention that in the preamble of the CY 2017 Quality Payment Program final rule (81 FR 77186 and 77179), the terminology ‘‘automatic’’ was used in reference to patient-centered medical home or comparable specialty practice improvement activities scoring credit. In that rule (81 FR 77186), in response to one comment, we stated, ‘‘. . . any MIPS eligible clinician or group that does not qualify by October 1st of the performance year as a certified patient- VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 centered medical home or comparable specialty practice cannot receive automatic credit as such for the improvement activities performance category.’’ In response to another comment in that rule (81 FR 77179), we stated, ‘‘Other certifications that are not for patient-centered medical homes or comparable specialty practices would also not qualify automatically for the highest score.’’ While we used the term ‘‘automatic’’ then, we have since come to realize it is inaccurate because an eligible clinician or group must attest to their status as a patient-centered medical home or comparable specialty practice in order to receive full credit for the improvement activities performance category. In the CY 2018 Quality Payment Program final rule (82 FR 53649), in response to comments we received regarding patient-centered medical homes or comparable specialty practices receiving full credit for the improvement activities performance category for MIPS, we stated that we would like to make clear that credit is not automatically granted; MIPS eligible clinicians and groups must attest in order to receive the credit. Therefore, in the CY 2019 PFS proposed rule (83 FR 35963), we proposed codifying at § 414.1380(b)(3)(ii) to require that an eligible clinician or group must attest to their status as a patient-centered medical home or comparable specialty practice in order to receive this credit. Specifically, MIPS eligible clinicians who wish to claim this status for purposes of receiving full credit in the improvement activities performance category must attest to their status as a patient-centered medical home or comparable specialty practice for a continuous 90-day minimum during the performance period. We solicited comments on the above proposal. We received the following comment on this proposal. Comment: One commenter supported the proposal to modify current regulations to more clearly and concisely capture previously established policies for patient-centered Medical Homes and comparable specialty practices. Response: We thank the commenter for your support. After consideration of the comment we received, we are finalizing our changes to regulation text at § 414.1380(b)(3)(ii) as proposed. (E) Improvement Activities Performance Category Weighting for Final Scoring In the CY 2019 PFS proposed rule (83 FR 35963), in an effort to more clearly PO 00000 Frm 00034 Fmt 4701 Sfmt 4700 and concisely capture previously established policies, we proposed to make technical changes to § 414.1355(b) to state that unless a different scoring weight is assigned by CMS under section 1848(q)(5)(F) of the Act, performance in the improvement activities performance category comprises 15 percent of a MIPS eligible clinician’s final score for the 2019 MIPS payment year and for each MIPS payment year thereafter). We stated that we believe these changes would better align the regulation text with the text of the statute. We solicited comments on the above proposal. We did not receive any comments on this proposal. We are finalizing our changes to regulation text at § 414.1355(b) as proposed. (ii) CEHRT Bonus In the CY 2017 Quality Payment Program final rule (81 FR 77202 through 77209) and the CY 2018 Quality Payment Program final rule (82 FR 53664 through 53670), we established that certain activities in the improvement activities performance category will qualify for a bonus under the Promoting Interoperability performance category if they are completed using CEHRT. This bonus is applied under the Promoting Interoperability performance category and not under the improvement activities performance category. In the CY 2019 PFS proposed rule (83 FR 35932), we proposed a new approach for scoring the Promoting Interoperability performance category that is aligned with our MIPS program goals of flexibility and simplicity. We refer readers to section III.I.3.h.(5)(g) of this final rule for a summary of the comments we received regarding this proposal and our responses. (f) Scoring the Promoting Interoperability Performance Category We refer readers to section III.I.3.h.(5) of this final rule, where we discuss our proposals for scoring the Promoting Interoperability performance category. (2) Calculating the Final Score For a description of the statutory basis and our policies for calculating the final score for MIPS eligible clinicians, we refer readers to § 414.1380(c), the discussion in the CY 2017 Quality Payment Program final rule (81 FR 77319 through 77329), and the discussion in the CY 2018 Quality Payment Program final rule (82 FR 53769 through 53785). In this final rule, we discuss our proposal to continue the complex patient bonus for the 2021 MIPS payment year, as well as a E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations modification to the final score calculation for the 2021 MIPS payment year. Finally, we discuss refinements to reweighting policies. (a) Accounting for Risk Factors Section 1848(q)(1)(G) of the Act requires us to consider risk factors in our scoring methodology. Specifically, it provides that the Secretary, on an ongoing basis, shall, as the Secretary determines appropriate and based on individuals’ health status and other risk factors, assess appropriate adjustments to quality measures, cost measures, and other measures used under MIPS and assess and implement appropriate adjustments to payment adjustments, final scores, scores for performance categories, or scores for measures or activities under MIPS. In doing so, the Secretary is required to take into account the relevant studies conducted under section 2(d) of the Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act) and, as appropriate, other information, including information collected before completion of such studies and recommendations. amozie on DSK3GDR082PROD with RULES3 (i) Considerations for Social Risk In the CY 2019 PFS proposed rule (83 FR 35964), we summarized our efforts related to social risk and the relevant studies conducted under section 2(d) of the IMPACT Act. We received several comments suggesting various approaches to adjust for social risk factors in the Quality Payment Program going forward. We thank commenters for their input and will take this input into consideration in future years. We also plan to continue working with ASPE, the public, and other key stakeholders on this important issue to identify policy solutions that achieve the goals of attaining health equity for all beneficiaries and minimizing unintended consequences. (ii) Complex Patient Bonus for the 2021 MIPS Payment Year In the CY 2018 Quality Payment Program final rule, under the authority in section 1848(q)(1)(G) of the Act, we finalized at § 414.1380(c)(3) a complex patient bonus of up to 5 points to be added to the final score for the 2020 MIPS payment year (82 FR 53771 through 53776). We intended for this bonus to serve as a short-term strategy to address the impact patient complexity may have on MIPS scoring while we continue to work with stakeholders on methods to account for patient risk factors. Our overall goal for the complex patient bonus was twofold: (1) To protect access to care for VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 complex patients and provide them with excellent care; and (2) to avoid placing MIPS eligible clinicians who care for complex patients at a potential disadvantage while we review the completed studies and research to address the underlying issues. We noted that we would assess on an annual basis whether to continue the bonus and how the bonus should be structured (82 FR 53771). For a detailed description of the complex patient bonus finalized for the 2020 MIPS payment year, please refer to the CY 2018 Quality Payment Program final rule (82 FR 53771 through 53776). For the 2019 MIPS performance period/2021 MIPS payment year, we proposed in the CY 2019 PFS proposed rule to continue the complex patient bonus as finalized for the 2018 MIPS performance period/2020 MIPS payment year and to revise § 414.1380(c)(3) to reflect this policy (83 FR 35964 through 35965). Although we intended to maintain the complex patient bonus as a short-term solution, we did not believe we had sufficient information available at the time of the proposed rule to develop a long-term solution to account for patient risk factors in MIPS such that we would be able to propose a different approach for the 2019 MIPS performance period/2021 MIPS payment year. At the time of the proposed rule, we did not believe additional data sources were available that would be feasible to use as the basis for a different approach to account for patient risk factors in MIPS. In the CY 2019 PFS proposed rule, we noted our intention to analyze data when feasible from the 2017 MIPS performance period to identify differences in performance that are consistent across performance categories and that we may, in the future, shift the complex patient bonus to specific performance categories (83 FR 35965). In the absence of data analysis from the first year of MIPS, we did not believe that a change was appropriate at that time. Therefore, we stated that while we work with stakeholders to identify a long-term approach to account for patient risk factors in MIPS, we believed it was appropriate to continue the complex patient bonus for another year to support MIPS eligible clinicians who treat patients with risk factors, as well as to maintain consistency with the 2020 MIPS payment year and minimize confusion. We had received significant feedback from MIPS eligible clinicians that consistency in the MIPS program over time is valued when possible in order to minimize confusion and to help MIPS eligible clinicians predict how they will be scored under MIPS. PO 00000 Frm 00035 Fmt 4701 Sfmt 4700 59869 Therefore, we stated our belief that it is appropriate to maintain consistent policies for the complex patient bonus in the 2021 MIPS payment year until we have sufficient evidence and new data sources that support an updated approach to account for patient risk factors. Although we did not propose changes to the complex patient bonus for the 2021 MIPS payment year, we stated that the dates used in the calculation of the complex patient bonus may change as a result of other proposals we made in the CY 2019 PFS proposed rule (83 FR 35885 through 35886). For the 2020 MIPS payment year, we finalized that we will use the second 12-month segment of the eligibility determination period to calculate average HCC risk scores and the proportion of full benefit or partial benefit dual eligible beneficiaries for MIPS eligible clinicians (82 FR 53771 through 53772). We proposed to change the dates of the eligibility determination period (now referred to as the MIPS determination period) beginning with the 2021 MIPS payment year (83 FR 35885 through 35886). Specifically, the second 12month segment would begin on October 1 of the calendar year preceding the applicable performance period and end on September 30 of the calendar year in which the applicable performance period occurs. We indicated that if this proposed change to the MIPS determination period is finalized, then beginning with the 2021 MIPS payment year, the second 12-month segment of the MIPS determination period (beginning on October 1 of the calendar year preceding the applicable performance period and ending on September 30 of the calendar year in which the applicable performance period occurs) would be used when calculating average HCC risk scores and proportion of full benefit or partial benefit dual eligible beneficiaries for MIPS eligible clinicians. We solicited comments on the above proposals. These comments and our responses are discussed below. Comment: Several commenters supported our proposal to continue the complex patient bonus for the 2019 MIPS performance period/2021 MIPS payment year. Commenters stated that the bonus helps to create fairer scoring for MIPS eligible clinicians. Some commenters requested that we continue the bonus beyond the 2019 MIPS performance period/2021 MIPS payment year. A few commenters supported the complex patient bonus but requested that we increase the complex patient bonus above the proposed 5 points, stating that 5 points E:\FR\FM\23NOR3.SGM 23NOR3 59870 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations will have a minimal impact on the final score. Response: We thank commenters for their support of our proposal to maintain the complex patient bonus for the 2019 MIPS performance period/2021 MIPS payment year. We plan to review available information, including any updated data, in future years to determine if it is appropriate to modify our approach to adjusting for social risk factors. As we stated in the CY 2018 Quality Payment Program final rule (82 FR 53775), we believe a complex patient bonus of 5 points added to the final score is appropriate and is justified by information currently available at this time. Comment: Several commenters did not support our approach for the complex patient bonus. Commenters pointed out limitations in the use of HCC and dual-eligibility to calculate the complex patient bonus. For instance, commenters stated that these indicators are not sufficient to adjust for differences in performance and suggested other indicators that might be more appropriate (such as income or education). Commenters urged us to continue to explore alternative methods to adjust for patient complexity in future years. Response: We understand that both HCC risk scores and dual eligibility have some limitations as proxies for social risk factors. However, we are not aware of data sources for indicators such as income and education that are readily available for all Medicare beneficiaries that would be more complete indices of a patient’s complexity. We have decided to pair the HCC risk score with the proportion of dual eligible patients to create a more complete complex patient indicator than can be captured using HCC risk scores alone. We will evaluate additional options in future years based on any updated data or additional information in order to better account for social risk factors while minimizing unintended consequences. Comment: One commenter recommended that we use the 12-month performance period to determine the complex patient bonus, stating that it is the most accurate representation of the patient population of a MIPS eligible clinician. Response: We believe that aligning the time period for assigning beneficiaries for purposes of calculating the complex patient bonus with the MIPS determination period is preferable for simplicity. In addition, when we designed our systems, we incorporated user feedback that requested eligibility information be connected to data submission. In order to be able to provide this information on the complex patient bonus at or near the time of data submission, it is necessary to use the second 12-month segment of the MIPS determination period as proposed to identify beneficiaries for purposes of assigning HCC risk scores and full benefit or partial benefit dual eligible beneficiaries to MIPS eligible clinicians, rather than the performance period. We note that this second 12-month segment begins 3 months before the year in which the performance period occurs and ends 9 months into the year in which the performance period occurs, creating a considerable overlap between the MIPS determination period and the year in which the performance period occurs (9 months). After consideration of public comments, we are finalizing our proposal to continue the complex patient bonus for the 2019 MIPS performance period/2021 MIPS payment year as proposed. We are also finalizing the changes to the regulation text at § 414.1380(c)(3) as proposed. We are also modifying the timing used to calculate the complex patient bonus based on our changes to the MIPS determination period finalized in III.I.3.b. of this final rule. The second 12-month segment of the MIPS determination period will be used when calculating average HCC risk scores and the proportion of full benefit or partial benefit dual eligible beneficiaries for MIPS eligible clinicians. (b) Final Score Performance Category Weights (i) General Weights Section 1848(q)(5)(E)(i) of the Act specifies weights for the performance categories included in the MIPS final score: In general, 30 percent for the quality performance category; 30 percent for the cost performance category; 25 percent for the Promoting Interoperability (formerly advancing care information) performance category; and 15 percent for the improvement activities performance category. For more of the statutory background and descriptions of our current policies, we refer readers to the CY 2017 and CY 2018 Quality Payment Program final rules (81 FR 77320 and 82 FR 53779, respectively). Under the proposals we are finalizing in sections III.I.3.h.(3)(a) and III.I.3.h.(2)(a)(ii) of this final rule, for the 2021 MIPS payment year, the cost performance category will make up 15 percent and the quality performance category will make up 45 percent of a MIPS eligible clinician’s final score. Table 53 summarizes the weights specified for each performance category. TABLE 53—FINALIZED WEIGHTS BY MIPS PERFORMANCE CATEGORY AND MIPS PAYMENT YEAR 2019 MIPS payment year (previously finalized) (percent) Performance category amozie on DSK3GDR082PROD with RULES3 Quality .......................................................................................................................................... Cost .............................................................................................................................................. Improvement Activities ................................................................................................................. Promoting Interoperability ............................................................................................................ (ii) Flexibility for Weighting Performance Categories Under section 1848(q)(5)(F) of the Act, if there are not sufficient measures and activities applicable and available to each type of MIPS eligible clinician involved, the Secretary shall assign VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 different scoring weights (including a weight of zero) for each performance category based on the extent to which the category is applicable to the type of MIPS eligible clinician involved and for each measure and activity with respect to each performance category based on the extent to which the measure or PO 00000 Frm 00036 Fmt 4701 Sfmt 4700 60 0 15 25 2020 MIPS payment year (previously finalized) (percent) 50 10 15 25 2021 MIPS payment year (finalized) (percent) 45 15 15 25 activity is applicable and available to the type of MIPS eligible clinician involved. Under section 1848(q)(5)(B)(i) of the Act, in the case of a MIPS eligible clinician who fails to report on an applicable measure or activity that is required to be reported by the clinician, the clinician must be treated as E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations amozie on DSK3GDR082PROD with RULES3 achieving the lowest potential score applicable to such measure or activity. In this scenario of failing to report, the MIPS eligible clinician would receive a score of zero for the measure or activity, which would contribute to the final score for that MIPS eligible clinician. Assigning a scoring weight of zero percent and redistributing the weight to the other performance categories differs from the scenario of a MIPS eligible clinician failing to report on an applicable measure or activity that is required to be reported. (A) Scenarios Where the Quality, Cost, Improvement Activities, and Promoting Interoperability Performance Categories Would Be Reweighted In the CY 2017 and CY 2018 Quality Payment Program final rules (81 FR 77322 through 77325 and 82 FR 53779 through 53780, respectively), we explained our interpretation of what it means for there to be sufficient measures applicable and available for the quality and cost performance categories, and we finalized policies for the 2019 and 2020 MIPS payment years under which we would assign a scoring weight of zero percent to the quality or cost performance category and redistribute its weight to the other performance categories in the event there are not sufficient measures applicable and available, as authorized by section 1848(q)(5)(F) of the Act. For the quality performance category, we stated that having sufficient measures applicable and available means that we can calculate a quality performance category percent score for the MIPS eligible clinician because at least one quality measure is applicable and available to the clinician (82 FR 53780). For the cost performance category, we stated that having sufficient measures applicable and available means that we can reliably calculate a score for the cost measures that adequately captures and reflects the performance of a MIPS eligible clinician (82 FR 53780). We established that if a MIPS eligible clinician is not attributed enough cases for a cost measure (in other words, has not met the required case minimum for the measure), or if a cost measure does not have a benchmark, then the measure will not be scored for that clinician (81 FR 77323). We stated that if we do not score any cost measures for a MIPS eligible clinician in accordance with this policy, then the clinician would not receive a cost performance category percent score (82 FR 53780). In the CY 2019 PFS proposed rule, we proposed to codify these policies for the quality and cost performance categories at § 414.1380(c)(2)(i)(A)(1) and (2), VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 respectively, and to continue them for the 2021 MIPS payment year and each subsequent MIPS payment year (83 FR 35966). For the Promoting Interoperability performance category, in the CY 2017 Quality Payment Program final rule (81 FR 77238 through 77245) and the CY 2018 Quality Payment Program final rule (82 FR 53680 through 53687), we established policies for assigning a scoring weight of zero percent to the Promoting Interoperability performance category and redistributing its weight to the other performance categories in the final score. We proposed to codify those policies under § 414.1380(c)(2)(i) and (iii) (83 FR 35966). For the improvement activities performance category, we stated in the CY 2019 proposed rule (83 FR 35967 through 35968) that we continue to believe that all MIPS eligible clinicians will have sufficient activities applicable and available, except for limited extreme and uncontrollable circumstances, such as natural disasters, where a clinician is unable to report improvement activities, and circumstances where a MIPS eligible clinician joins a practice in the final 3 months of the performance period as discussed in the CY 2019 PFS proposed rule (83 FR 35967 through 35968). We stated that, barring these circumstances, we believe that all MIPS eligible clinicians will have sufficient improvement activities applicable and available (82 FR 53780). We solicited comments on the above proposals. These comments and our responses are discussed below. Comment: One commenter supported our reweighting policies, stating that they provide flexibility for MIPS eligible clinicians who are unable to participate in specific performance categories. Response: We thank this commenter for its support. Comment: One commenter expressed concern with our reweighting policies, because the commenter believes MIPS eligible clinician may expend resources to submit data to us, and then receive reweighting based on our determination that there are not sufficient measures or activities applicable and available. Response: Our reweighting policies would not lead us to reweight a MIPS eligible clinician after they submit data for a given performance category. Rather, we would consider whether these policies are applicable in the event that we do not receive any data for a MIPS eligible clinician for a particular performance category. If we determine that the clinician is eligible for reweighting under our policies, then we would redistribute the weight of the PO 00000 Frm 00037 Fmt 4701 Sfmt 4700 59871 performance category, rather than awarding a score of zero to the clinician for that performance category. After consideration of public comments, we are finalizing our proposal to codify the reweighting policies for the quality and cost performance categories at § 414.1380(c)(2)(i)(A)(1) and (2), respectively, and to continue them for the 2021 MIPS payment year and each subsequent MIPS payment year, as proposed. We are also finalizing our proposal to codify the Promoting Interoperability reweighting policies under § 414.1380(c)(2)(i) and (iii) as proposed. (B) Reweighting the Quality, Cost, and Improvement Activities Performance Categories for Extreme and Uncontrollable Circumstances For a summary of the final policy we adopted beginning with the 2018 MIPS performance period/2020 MIPS payment year to reweight the quality, cost, and improvement activities performance categories based on a request submitted by a MIPS eligible clinician, group, or virtual group that was subject to extreme and uncontrollable circumstances, we refer readers to the CY 2018 Quality Payment Program final rule (82 FR 53780 through 53783). In the proposed rule (83 FR 35966), we proposed to codify this policy at § 414.1380(c)(2)(i)(A)(5), but we inadvertently referred to the wrong paragraph of the regulation text, and the citation should have read § 414.1380(c)(2)(i)(A)(6). We proposed a few minor modifications to our extreme and uncontrollable circumstances policy (83 FR 35967). First, beginning with the 2019 MIPS performance period/2021 MIPS payment year, we proposed at § 414.1380(c)(2)(i)(A)(5) (which should have read § 414.1380(c)(2)(i)(A)(6)) that, if a MIPS eligible clinician submits an application for reweighting based on extreme and uncontrollable circumstances, but also submits data on the measures or activities specified for the quality or improvement activities performance categories in accordance with § 414.1325, he or she would be scored on the submitted data like all other MIPS eligible clinicians, and the categories would not be reweighted (83 FR 35967). We proposed this modification to align with a similar policy for the Promoting Interoperability performance category (82 FR 53680 through 53682). We stated that if a MIPS eligible clinician reports on measures or activities specified for the quality or improvement activities performance categories, then we assume the clinician E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59872 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations believes there are sufficient measures or activities applicable and available to the clinician. For most quality measures and improvement activities, the data submission occurs after the end of the MIPS performance period, so clinicians would know about the extreme and uncontrollable circumstance prior to submission. However, for the quality performance category, measures submitted via the Medicare Part B claims collection type are submitted by adding quality data codes to a claim. As a result, it is possible that a MIPS eligible clinician could have submitted some Medicare Part B claims collection type data prior to the submission of a reweighting application for extreme and uncontrollable events. Under our proposal, we would score the quality performance category because we have received data. However, we previously finalized at § 414.1380(c) that if a MIPS eligible clinician is scored on fewer than two performance categories, he or she will receive a final score equal to the performance threshold (81 FR 77320 through 77321 and 82 FR 53778 through 53779). If a clinician experiences an extreme and uncontrollable event that affects all of the performance categories, then under our proposal, the clinician would only be scored on the quality performance category if they submit data for only that category. The clinician would also have to submit data for the improvement activities or the Promoting Interoperability performance categories in order to be scored on two or more performance categories and receive a final score different than the performance threshold. This proposal did not include administrative claims data that we receive through the claims submission process and use to calculate the cost measures and certain quality measures. As finalized in the CY 2017 Quality Payment Program final rule (81 FR 77094 through 77095), and as we are codifying in this final rule at § 414.1325(a)(2), there are no data submission requirements for the cost performance category and for certain quality measures used to assess performance in the quality performance category. Please see section III.I.3.h.(1)(b) of this final rule for a description of collection types, submission types, and submitter types. We calculate performance on these measures using administrative claims data, and clinicians are not required to submit any additional data for these measures. Therefore, we stated that we did not believe that it would be appropriate to void a reweighting application based on administrative VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 claims data we receive for measures that do not require data submission for purposes of MIPS. We also proposed to apply the policy we finalized for virtual groups in the CY 2018 Quality Payment Program final rule (82 FR 53782 through 53783) to groups submitting reweighting applications for the quality, cost, or improvement activities performance categories based on extreme and uncontrollable circumstances (83 FR 35967). For groups, we would evaluate whether sufficient measures and activities are applicable and available to MIPS eligible clinicians in the group on a case-by-case basis and determine whether to reweight a performance category based on the information provided for the individual clinicians and practice location(s) affected by extreme and uncontrollable circumstances and the nature of those circumstances. In the CY 2019 PFS proposed rule (83 FR 35967), we stated that although we did not specifically propose to apply this policy to groups in the CY 2018 Quality Payment Program proposed rule, our intention was to apply the same policy for groups and virtual groups, and thus if we adopt this proposal, we would apply the policy to groups beginning with the 2018 performance period/2020 MIPS payment year. We solicited comments on the above proposals. These comments and our responses are discussed below. Comment: One commenter supported our proposal for groups, stating that all MIPS eligible clinicians in the group will likely be facing the same barriers and a group application will reduce administrative burden and redundancy. Response: We thank the commenter for its support of our proposal to apply the same policy we established for virtual groups to groups. Under the proposed policy, we would evaluate whether sufficient measures and activities are applicable and available to MIPS eligible clinicians in the group on a case-by-case basis and determine whether to reweight a performance category based on the information provided for the individual clinicians and practice location(s) affected by extreme and uncontrollable circumstances and the nature of those circumstances. Comment: One commenter expressed concern that MIPS eligible clinicians who submit an application for reweighting based on extreme and uncontrollable circumstances, but who also report via Medicare Part B claims collection type may be unfairly penalized if claims data is received prior to the extreme and uncontrollable PO 00000 Frm 00038 Fmt 4701 Sfmt 4700 event. Another commenter suggested that we should score data received from MIPS eligible clinicians who submit a reweighting application only if they would receive a score that would result in a payment adjustment no lower than a neutral adjustment. Response: If a MIPS eligible clinician reports via Medicare Part B claims collection type for the quality performance category, and we receive an application for reweighting for the clinician based on extreme and uncontrollable circumstances, their Medicare Part B claims data would only contribute to their final score if they also submit data for either the Promoting Interoperability or the improvement activities performance categories. We previously finalized at § 414.1380(c) that if a MIPS eligible clinician is scored on fewer than two performance categories, he or she will receive a final score equal to the performance threshold (81 FR 77320 through 77321 and 82 FR 53778 through 53779). The clinician’s cost performance category score would not contribute to their final score because as we discuss above, there are no data submission requirements for the cost performance category, and we do not believe that it would be appropriate to void a reweighting application based on administrative claims data we receive for measures that do not require data submission for purposes of MIPS. We assume that if a MIPS eligible clinician submits data to us following the submission of an application for reweighting based on extreme and uncontrollable circumstances, the clinician believes there are sufficient measures or activities applicable and available to them and would like their data to contribute to their final score. However, once the data is submitted, it will be scored based on performance in accordance with our policies, and the clinician could receive a negative payment adjustment. After consideration of public comments, we are finalizing our proposal to codify the final policy we adopted beginning with the 2018 MIPS performance period/2020 MIPS payment year to reweight the quality, cost, and improvement activities performance categories based on a request submitted by a MIPS eligible clinician, group, or virtual group that was subject to extreme and uncontrollable circumstances. We are finalizing our proposal that, beginning with the 2019 performance period/2021 MIPS payment year, if a MIPS eligible clinician submits an application for reweighting based on extreme and uncontrollable circumstances, but also E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations amozie on DSK3GDR082PROD with RULES3 submits data on the measures or activities specified for the quality or improvement activities performance categories in accordance with § 414.1325, he or she will be scored on the submitted data like all other MIPS eligible clinicians, and the categories will not be reweighted. We are also finalizing our proposal, beginning with the 2018 performance period/2020 MIPS payment year, that, for groups, we will evaluate whether sufficient measures and activities are applicable and available to MIPS eligible clinicians in the group on a case-by-case basis and determine whether to reweight a performance category based on the information provided. We are finalizing the regulation text at § 414.1380(c)(2)(i)(A)(6) as proposed. (C) Reweighting the Quality, Cost, Improvement Activities, and Promoting Interoperability Performance Categories for MIPS Eligible Clinicians Who Join a Practice in the Final 3 Months of the Performance Period Year Beginning with the 2019 MIPS performance period, we proposed that a MIPS eligible clinician who joins an existing practice (existing TIN) during the final 3 months of the calendar year in which the MIPS performance period occurs (the performance period year) that is not participating in MIPS as a group would not have sufficient measures applicable and available (83 FR 35967 through 35968). We also proposed that a MIPS eligible clinician who joins a practice that is newly formed (new TIN) during the final 3 months of the performance period year would not have sufficient measures applicable and available, regardless of whether the clinicians in the practice report for purposes of MIPS as individuals or as a group (83 FR 35967 through 35968). In each of these scenarios, we proposed to reweight all four of the performance categories to zero percent for the MIPS eligible clinician and, because he or she would be scored on fewer than two performance categories, the MIPS eligible clinician would receive a final score equal to the performance threshold and a neutral MIPS payment adjustment under the policy at § 414.1380(c) (83 FR 35967 through 35968). We proposed to codify these policies at § 414.1380(c)(2)(i)(A)(3). We proposed this policy because we are not currently able to identify these MIPS eligible clinicians (or groups if the group is formed in the final 3 months of the performance period year) at the start of the MIPS submission period. When we designed our systems, we incorporated user feedback that VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 requested eligibility information be connected to the submission process. In order to submit data, an individual TIN/ NPI or the group TIN must be in the files generated from the MIPS eligibility determination periods. As discussed in the CY 2019 PFS proposed rule (83 FR 35885 through 35886), we have two 12month determination periods for eligibility. We proposed and are finalizing in section III.II.3.b. of this final rule that the second 12-month segment of the MIPS eligibility determination period will end on September 30 of the calendar year in which the applicable MIPS performance period occurs; therefore, we will have no eligibility information about clinicians who join a practice after September 30 of the performance period year. MIPS eligible clinicians who join an existing practice (existing TIN) in the final 3 months of the performance period year that is not participating in MIPS as a group will not be identified by our systems, and we will not have the ability to inform them that they are eligible or to receive MIPS data from them. Similarly, practices that form (new TIN) in the final 3 months of the performance period year will not be in the MIPS determination files. Accordingly, we stated that the measures and activities would not be available because any data from these MIPS eligible clinicians would not be accessible to us. If a MIPS eligible clinician joins a practice (existing TIN) in the final 3 months of the performance period year, and the practice is not newly formed and is reporting as a group for the performance period, the MIPS eligible clinician will be able to report as part of that group. In this case, we are able to accept data for the group because the TIN would be in our MIPS eligibility determination files. Therefore, we stated that we believe the measures and activities would be available in this scenario, and reweighting would not be necessary for the MIPS eligible clinician. We noted that, if a MIPS eligible clinician’s TIN/NPI combination was not part of the group practice during the MIPS determination period, the TIN/NPI combination will not be identified in our system at the start of the MIPS data submission period; however, if the MIPS eligible clinician qualifies to receive the group final score under our proposal, we would apply the group final score to the MIPS eligible clinician’s TIN/NPI combination as soon as the information becomes available. Please see section III.I.3.j.(1) of this final rule for more information about PO 00000 Frm 00039 Fmt 4701 Sfmt 4700 59873 assigning group scores to MIPS eligible clinicians. We solicited comments on the above proposals. These comments and our responses are discussed below. Comment: Several commenters supported our proposal to reweight MIPS eligible clinicians who form a new practice in the final 3 months of the performance period year or join an existing practice that does not participate in MIPS as a group. Response: We thank commenters for their support of our proposal. Comment: One commenter requested that we extend this policy to the 2018 performance period as well. Response: We note that we did not propose to apply the policy to the 2018 performance period, and as such, we will not be extending it in this final rule. Comment: One commenter did not support our proposal to treat MIPS eligible clinicians who join a new or existing practice in the final 3 months of the performance period year differently depending on whether the practice reports as a group. The commenter also requested that we reweight MIPS eligible clinicians who switch practices at any time during the performance period, because a MIPS eligible clinician’s previous practice may not report on their behalf and because clinicians are impacted by training and other requirements associated with switching practices that may impact performance. Response: A MIPS eligible clinician who joins an existing practice that is participating in MIPS as a group would have the opportunity to contribute to the group’s performance and final score. We refer readers to section III.I.3.j.(1) of this final rule for a discussion of which MIPS eligible clinicians may receive a group final score. We do not believe it would be appropriate to reweight the performance categories for MIPS eligible clinicians who change practices at any time during the performance period year because, consistent with our discussion in the CY 2019 PFS proposed rule (83 FR 35967 through 35968), we would be able to identify these clinicians at the beginning of the MIPS submission period if they change practices prior to the final 3 months of the performance period year. We also believe MIPS eligible clinicians who change practices prior to the final 3 months of the performance period year generally should have sufficient time to prepare for MIPS reporting, in the event that their prior practice does not submit data for them. After consideration of public comments, we are finalizing as E:\FR\FM\23NOR3.SGM 23NOR3 59874 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations amozie on DSK3GDR082PROD with RULES3 proposed our proposal to reweight the quality, cost, improvement activities, and Promoting Interoperability performance categories to zero percent for MIPS eligible clinicians who join an existing practice (existing TIN) during the final 3 months of the performance period year that is not participating in MIPS as a group, or a practice that is newly formed (new TIN) during the final 3 months of the performance period year regardless of whether the clinicians in the practice report for purposes of MIPS as individuals or as a group. We are finalizing the proposed regulation text at § 414.1380(c)(2)(i)(A)(3) as proposed. (D) Automatic Extreme and Uncontrollable Circumstances Policy Beginning With the 2020 MIPS Payment Year In conjunction with the CY 2018 Quality Payment Program final rule, and due to the impact of Hurricanes Harvey, Irma, and Maria, we issued an interim final rule with comment period (IFC) in which we adopted on an interim final basis a policy for automatically reweighting the quality, improvement activities, and advancing care information (now referred to as Promoting Interoperability) performance categories for the transition year of MIPS (the 2017 performance period/ 2019 MIPS payment year) for MIPS eligible clinicians who are affected by extreme and uncontrollable circumstances affecting entire regions or locales (82 FR 53895 through 53900). In the CY 2019 PFS proposed rule (83 FR 35968), we stated that we believe that a similar automatic extreme and uncontrollable circumstances policy would be appropriate for any year of the MIPS program to account for natural disasters and other extreme and uncontrollable circumstances that impact an entire region or locale. As we discussed in the interim final rule (82 FR 53897), we believe such a policy would reduce burden on clinicians who have been affected by widespread catastrophes and would align with existing policies for other Medicare programs. We proposed at § 414.1380(c)(2)(i)(A)(7) and (c)(2)(i)(C)(3) to apply the automatic extreme and uncontrollable circumstances policy we adopted for the transition year to subsequent years of the MIPS program, beginning with the 2018 MIPS performance period and the 2020 MIPS payment year, with a few additions to address the cost performance category (83 FR 35968). We note that we inadvertently referred to the wrong paragraph of the regulation text in the proposed rule, and the VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 citation should have read § 414.1380(c)(2)(i)(A)(8) instead of § 414.1380(c)(2)(i)(A)(7). For a description of the policy we adopted for the MIPS transition year, we refer readers to the discussion in the interim final rule (82 FR 53895 through 53900). In the interim final rule (82 FR 53897), we stated that we were not including the cost performance category in the automatic extreme and uncontrollable circumstances policy for the transition year because the cost performance category is weighted at zero percent in the final score for the 2017 MIPS performance period/2019 MIPS payment year. We finalized a 10 percent weight for the cost performance category for the 2018 MIPS performance period/2020 MIPS payment year (82 FR 53643) and are finalizing a 15 percent weight for the 2019 performance period/ 2021 MIPS payment year (see section III.I.3.h.(3)(a) of this final rule). In the CY 2019 PFS proposed rule (83 FR 35968), we stated that for the reasons discussed in the CY 2018 Quality Payment Program final rule (82 FR 53781), we believe a MIPS eligible clinician’s performance on measures calculated based on administrative claims data, such as the measures specified for the cost performance category, could be adversely affected by a natural disaster or other extreme and uncontrollable circumstance, and that the cost measures may not be applicable to that MIPS eligible clinician. Therefore, we proposed to include the cost performance category in the automatic extreme and uncontrollable circumstances policy beginning with the 2018 MIPS performance period/2020 MIPS payment year (83 FR 35968). Under our policy for the transition year, if a MIPS eligible clinician in an affected area submits data for any of the MIPS performance categories by the applicable submission deadline for the 2017 MIPS performance period, he or she will be scored on each performance category for which he or she submits data, and the performance category will not be reweighted to zero percent in the final score (82 FR 53898). Our policy for the transition year did not include measures that are calculated based on administrative claims data (82 FR 53898). As finalized in the CY 2017 Quality Payment Program final rule (81 FR 77094 through 77095), and as we are codifying in this final rule at § 414.1325(a)(2), there are no data submission requirements for the cost performance category, and we will calculate performance on the measures specified for the cost performance category using administrative claims PO 00000 Frm 00040 Fmt 4701 Sfmt 4700 data. We proposed for the cost performance category, if a MIPS eligible clinician is located in an affected area, we would assume the clinician does not have sufficient cost measures applicable to him or her and assign a weight of zero percent to that category in the final score, even if we receive administrative claims data that would enable us to calculate the cost measures for that clinician (83 FR 35968). In the interim final rule (82 FR 53897), we did not include an automatic extreme and uncontrollable circumstances policy for groups or virtual groups, and we stated in the CY 2019 PFS proposed rule (83 FR 35968) that we continue to believe such a policy is not necessary. Unless we receive data from a TIN indicating that the TIN would like to be scored as a group for MIPS, performance by default is assessed at the individual MIPS eligible clinician level. Similarly, performance is not assessed at the virtual group level unless the member TINs submit an application in accordance with § 414.1315. We stated that if we receive data from a group or virtual group, we would score that data, even if individual MIPS eligible clinicians within the group or virtual group are impacted by an event that would be included in our automatic extreme and uncontrollable circumstances policy. Regardless of whether we receive data from a group or virtual group, we would have no mechanism to determine whether the group or virtual group did not submit data, or submitted data and performed poorly, because it had been affected by an extreme and uncontrollable event unless the group notifies us of its circumstances. Instead of establishing a threshold for groups or virtual groups to receive automatic reweighting based on the number of clinicians in the group or virtual group impacted by extreme and uncontrollable events, we stated that we believe it is preferable that these groups and virtual groups submit an application for reweighting based on extreme and uncontrollable circumstances under our existing policy (82 FR 53780 through 53783) where they may be eligible for reweighting if they establish that the group or virtual group was sufficiently impacted by the extreme and uncontrollable event. We solicited comments on the above proposals. These comments and our responses are discussed below. Comment: Several commenters supported our proposed application of the automatic extreme and uncontrollable policy starting with the 2018 MIPS performance period/2020 MIPS payment year to reduce burden on E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations impacted MIPS eligible clinicians. A few commenters supported our proposal to extend the automatic extreme and uncontrollable policy to include the cost performance category for the 2018 MIPS performance period/2020 MIPS payment year and future years. Response: We thank commenters for their support of our proposals. Comment: One commenter suggested that we only score performance categories (including the cost performance category) for MIPS eligible clinicians impacted by the automatic extreme and uncontrollable policy if they would receive a positive or neutral payment adjustment. Response: If a MIPS eligible clinician reports via Medicare Part B claims collection type for the quality performance category, and we receive data for the clinician prior to a triggering event for the automatic extreme and uncontrollable circumstances policy, their Medicare Part B claims data would only contribute to their final score if they also submit data for either the Promoting Interoperability or the improvement activities performance categories. We previously finalized at § 414.1380(c) that if a MIPS eligible clinician is scored on fewer than two performance categories, he or she will receive a final score equal to the performance threshold (81 FR 77320 through 77321 and 82 FR 53778 through 53779). We assume that if a MIPS eligible clinician submits data to us following a triggering event, the clinician believes there are sufficient measures or activities applicable and available to them and would like their data to contribute to their final score. However, once the data is submitted, it will be scored based on performance in accordance with our policies, and the clinician could receive a negative payment adjustment. Comment: One commenter disagreed with our decision to not propose an automatic extreme and uncontrollable circumstances policy for groups, because clinicians who choose to report as group for purposes of MIPS conduct all aspects of MIPS at a group level. Response: We continue to believe that a group policy is not necessary and that there are barriers to implementing such a policy. For example, because group reporting is optional, we would have no mechanism to determine who would have been intending to report without receiving a data submission. Additionally, some groups may be split between areas that are impacted by the triggering event and areas that are not. We do not believe that it would be appropriate to make a decision about VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 how the group is impacted without additional information. We believe our application-based extreme and uncontrollable circumstances policy provides the mechanism for such an assessment. Finally, we note that if all the MIPS eligible clinicians in a group are located in an area affected by the extreme and uncontrollable circumstance, and the group is not able to submit for MIPS as a group, then all the MIPS eligible clinicians in the group would be considered as individuals and covered by the automatic extreme and uncontrollable circumstances policy. After consideration of public comments received, we are finalizing these proposals and the regulation text at § 414.1380(c)(2)(i)(A)(8) and (c)(2)(i)(C)(3) as proposed. iii. Extreme and Uncontrollable Circumstance Policy for the 2017 Performance Period/2019 MIPS Payment Year As discussed in the preceding section III.I.3.i.(2)(b)(ii)(D), in conjunction with the CY 2018 Quality Payment Program final rule, and due to the impact of Hurricanes Harvey, Irma, and Maria, we issued an interim final rule with comment period (IFC) in which we adopted on an interim final basis a policy for automatically reweighting the quality, improvement activities, and advancing care information (now referred to as Promoting Interoperability) performance categories for the transition year of MIPS (the 2017 performance period/2019 MIPS payment year) for MIPS eligible clinicians who are affected by extreme and uncontrollable circumstances affecting entire regions or locales (82 FR 53895 through 53900). In the CY 2019 PFS proposed rule (83 FR 35968), we proposed to codify this policy for the quality and improvement activities performance categories at § 414.1380(c)(2)(i)(A)(6) and for the advancing care information (now Promoting Interoperability) performance category at § 414.1380(c)(2)(i)(C)(3). We note that we inadvertently referred to the wrong paragraph of the regulation text in the proposed rule, and the citation should have read § 414.1380(c)(2)(i)(A)(7) instead of § 414.1380(c)(2)(i)(A)(6). A summary of the comments we received on the IFC and our responses are included below. Comment: Many commenters supported the automatic extreme and uncontrollable circumstance policy for the 2017 MIPS performance period. Several commenters stated that the policy is appropriate given the burden these events have had on impacted PO 00000 Frm 00041 Fmt 4701 Sfmt 4700 59875 MIPS eligible clinicians. Several commenters supported the flexibility afforded by this policy and noted that the policy will allow impacted MIPS eligible clinicians to focus on providing patient care during natural disasters without having to focus on MIPS reporting. Several commenters supported our policy to allow clinicians impacted by extreme and uncontrollable events to report for MIPS if they choose because commenters believe some MIPS eligible clinicians may be less impacted by natural disasters and may have interest in reporting for MIPS. One commenter supported including events that have been designated by FEMA in the automatic extreme and uncontrollable circumstance policy. Another commenter supported using the practice location listed in PECOS to determine eligibility for the automatic extreme and uncontrollable policy. Response: We believe that the automatic extreme and uncontrollable circumstance policy is appropriate to provide relief to MIPS eligible clinicians experiencing natural disasters and will help to ensure they are able to focus on providing patient care. In the CY 2018 Quality Payment Program final rule, we noted that we anticipate the types of events that could trigger this policy would be events designated as FEMA major disasters or a public health emergency declared by the Secretary, although we will review each situation on a case-by-case basis (82 FR 53897). Comment: One commenter urged CMS to develop a clear communications plan for alerting MIPS eligible clinicians that they are eligible for the automatic extreme and uncontrollable circumstance policy. Response: We agree that it will be important to effectively alert MIPS eligible clinicians who we determine are covered by the automatic extreme and uncontrollable circumstance policy. Similar to other CMS programs, we communicated applicability information through routine communication channels, including, but not limited to, issuing memos, emails, and notices on the QPP website, qpp.cms.gov. Comment: One commenter stated that providing MIPS eligible clinicians who are impacted by extreme and uncontrollable events with a final score that is equal to the performance threshold if they report on only one performance category does not recognize their efforts for that performance category. Instead, commenter stated CMS should score the MIPS eligible clinician on that category. Response: We continue to believe that the final score for MIPS should be a composite score. Therefore, for MIPS E:\FR\FM\23NOR3.SGM 23NOR3 59876 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations amozie on DSK3GDR082PROD with RULES3 eligible clinicians who are subject to the automatic extreme and uncontrollable circumstance policy, we will continue to apply our general MIPS policy codified at § 414.1380(c) that MIPS eligible clinicians who are scored on fewer than 2 performance categories receive a score equal to the performance threshold (82 FR 53958). MIPS eligible clinicians who are located in an area affected by extreme and uncontrollable circumstances who submit data for the quality performance category would also have to submit data for the Promoting Interoperability or improvement activities performance categories in order for the data submitted to contribute to their final score. Comment: One commenter stated that scoring data that are submitted by impacted MIPS eligible clinicians is unfair because they are being assessed against MIPS eligible clinicians who were not impacted by natural disasters. Response: Because the performance threshold is set very low (at 3 points) for the 2017 MIPS performance period, we believe that MIPS eligible clinicians who are eligible for the automatic extreme and uncontrollable circumstance policy but submit data will easily exceed the performance threshold and thus will not be negatively impacted. Furthermore, we assume that MIPS eligible clinicians who are located in an area affected by extreme and uncontrollable circumstances but then submit data for more than one performance category believe there are sufficient measures or activities applicable and available to them and would like their data to contribute to their final score. Comment: One commenter suggested that CMS should not score Medicare Part B claims measures that are submitted by MIPS eligible clinicians impacted by extreme and uncontrollable events. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 Response: If a MIPS eligible clinician reports via Medicare Part B claims for the quality performance category and we receive data prior to the extreme and uncontrollable event, their Medicare Part B claims data would only contribute to their final score if they also submit data for either the Promoting Interoperability or improvement activities performance categories. We previously finalized at § 414.1380(c) that if a MIPS eligible clinician is scored on fewer than two performance categories, he or she will receive a final score equal to the performance threshold (81 FR 77320 through 77321 and 82 FR 53778 through 53779). Comment: One commenter suggested that CMS consider providing a positive payment adjustment for MIPS eligible clinicians who are eligible for the automatic extreme and uncontrollable circumstance policy instead of providing a neutral payment adjustment because this will help to incentivize MIPS eligible clinicians to return to affected areas. Response: It is unclear to us how a positive payment adjustment would incentivize clinicians to return to affected areas, or how we would go about verifying whether and why they have returned, since many factors influence clinician choice in practice location. After consideration of the public comments, we are adopting the IFC as a final rule without any modifications. We are finalizing the regulation text at § 414.1380(c)(2)(i)(A)(7) and § 414.1380(c)(2)(i)(C)(3) as proposed. (iv) Redistributing Performance Category Weights In the CY 2017 and CY 2018 Quality Payment Program final rules, we established policies for redistributing the weights of performance categories for the 2019 and 2020 MIPS payment PO 00000 Frm 00042 Fmt 4701 Sfmt 4700 years in the event that a scoring weight different from the generally applicable weight is assigned to a category or categories (81 FR 77325 through 77329; 82 FR 53783 through 53785, 53895 through 53900). We proposed to codify these policies under § 414.1380(c)(2)(ii) (83 FR 35969). For the 2021 MIPS payment year, we proposed at § 414.1380(c)(2)(ii)(B) to apply similar reweighting policies as finalized for the 2020 MIPS payment year (83 FR 35969). We note that we inadvertently referred to the wrong paragraph of the regulation text in the proposed rule, and the citation should have read § 414.1380(c)(2)(ii)(C) instead of § 414.1380(c)(2)(ii)(B). In general, we would redistribute the weight of a performance category or categories to the quality performance category. We stated that redistributing weight to the quality performance category is appropriate because of the experience MIPS eligible clinicians have had reporting on quality measures under other CMS programs. We proposed to continue to redistribute the weight of the quality performance category to the improvement activities and Promoting Interoperability performance categories (83 FR 35969). However, for the 2021 MIPS payment year, based on our proposal to weight the cost performance category at 15 percent, we proposed to reweight the Promoting Interoperability performance category to 45 percent and the improvement activities performance category to 40 percent when the quality performance category is weighted at zero percent (83 FR 35969). We chose to weigh Promoting Interoperability higher in order to align with goals of interoperability and for simplicity because we generally have avoided assigning partial percentage points to performance category weights. Reweighting scenarios under the proposal are presented in Table 54. E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations Interoperability performance category to the quality performance category is appropriate because MIPS eligible clinicians have had more experience reporting on quality measures under other CMS programs than reporting on improvement activities. We would redistribute the cost performance category weight equally to the quality and improvement activities performance categories (5 percent to each) under this alternative policy. ER23NO18.070</GPH> considered, we would redistribute the weight of the Promoting Interoperability performance category to the quality and improvement activities performance categories (83 FR 35969 through 35970). We would redistribute 15 percent of the Promoting Interoperability performance category weight to the quality performance category, and 10 percent to the improvement activities performance category. We stated that redistributing more of the weight of the Promoting VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00043 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.069</GPH> amozie on DSK3GDR082PROD with RULES3 We stated that we have heard from stakeholders in previous years that our reweighting policies place undue weight on the quality performance category, and, although we continue to believe the policies are appropriate, we solicited comment on alternative redistribution policies in which we would also redistribute weight to the improvement activities performance category (see Table 55). Under the alternative redistribution policy we 59877 amozie on DSK3GDR082PROD with RULES3 59878 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations We solicited comments on the above proposals. These comments and our responses are discussed below. Comment: A few commenters supported our proposed reweighting policies for the 2019 MIPS performance period/2021 MIPS payment year. Response: We thank commenters for their support of our proposal. Comment: Several commenters supported the alternative policy we considered to reweight to both quality and improvement activities, and stated our primary proposal which generally reweights to quality, places undue weight on the quality performance category. Some commenters stated that reweighting to the improvement activities performance category is appropriate given the importance of practice improvement. A few commenters stated that the quality performance category is particularly challenging, and therefore, placing additional weight on this performance category would not be fair to MIPS eligible clinicians who receive reweighting for the cost or Promoting Interoperability performance categories. A few commenters also mentioned that our reweighting policies place undue burden on small and rural practices who have particular difficulty performing well on the quality performance category. A few commenters requested that we redistribute all of the weight of the Promoting Interoperability or cost performance categories to the improvement activities performance category, in order to avoid placing undue focus on quality and due to the importance of quality improvement. Response: We continue to believe reweighting to the quality performance category is appropriate as the quality performance category is a critical component of value-based care, and therefore, we believe performance on quality measures is important. While there is variation in performance for the quality performance category, for the improvement activities we are only assessing whether the MIPS eligible clinician completed activities. We believe that reweighting to the quality performance category will encourage MIPS eligible clinicians to report on the quality performance category due to the higher category weight (that is, a zero score for this performance category would have more significant impact), particularly those clinicians who may have only reported to the improvement activities performance category, and will minimize complexity. We believe it is important to encourage MIPS eligible clinicians to report on quality while the performance threshold is still relatively low. In regards to the concern on small VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 and rural practice performance in the quality performance category, we note that small practices that report quality measures can receive the small practice bonus we are finalizing in section III.I.3.i.(1)(b)(viii) of this final rule and we have not seen differences in performance for rural practices. We plan to review available approaches to reweighting in future years including impact on small and rural practices and may revisit our policies to ensure they are fair and not overly complex. Comment: One commenter disagreed with our proposal to reweight the quality performance category to the improvement activities and Promoting Interoperability performance categories, because the commenter noted concern with our discussion of available and applicable measures for the quality performance category and reweighting this category would place greater weight on other performance categories. Another commenter noted that reweighting the quality performance category may lead to MIPS eligible clinicians inaccurately receiving a positive, neutral, or negative payment adjustment. Response: We believe reweighting to the improvement activities and Promoting Interoperability performance categories in the rare cases when the quality performance category is reweighted is appropriate because MIPS eligible clinicians have limited experience being scored on the cost performance category. We also expect the cases when a MIPS eligible clinician does not have any quality measures to be very rare. After consideration of public comments, we are finalizing these proposals and the regulation text at § 414.1380(c)(2)(ii)(A) through (C) as proposed. Because the cost performance category was zero percent of a MIPS eligible clinician’s final score for the 2017 MIPS performance period, we stated in the CY 2019 PFS proposed rule (83 FR 35970) that it is not appropriate to redistribute weight to the cost performance category for the 2019 MIPS performance period because MIPS eligible clinicians have limited experience being scored on cost measures for purposes of MIPS. In addition, we were concerned that there would be limited measures in the cost performance category under our proposals for the 2019 MIPS performance period and stated that it may be appropriate to delay shifting additional weight to the cost performance category until additional measures are developed. However, we also noted that cost is a critical PO 00000 Frm 00044 Fmt 4701 Sfmt 4700 component of the Quality Payment Program and believe placing additional emphasis on the cost performance category in future years may be appropriate. Therefore, we solicited comment on redistributing weight to the cost performance category in future years. We thank commenters for their input and will take this input into consideration in future years. (c) Final Score Calculation We proposed to revise the formula at § 414.1380(c) for calculating the final score (83 FR 35970). We did not propose to continue to add the small practice bonus to the final score for the 2021 MIPS payment year and proposed to add a small practice bonus to the quality performance category score instead starting with the 2021 MIPS payment year (83 FR 35950 through 35951). Therefore, we proposed to revise the formula to omit the small practice bonus from the final score calculation beginning with the 2021 MIPS payment year (83 FR 35970). We requested public comments on this proposal. Although we received several comments on the small practice bonus, we did not receive any comments on our proposed revisions to the formula to calculate the final score. We discuss our policy for our revised small practice bonus in the quality performance category in section III.I.3.i.(1)(b)(viii) of this final rule. After consideration of public comments, we are finalizing our proposed revisions to § 414.1380(c) as proposed. In the CY 2019 PFS proposed rule, we solicited comments on approaches to simplify calculation of the final score (83 FR 35970). We thank commenters for their input and will take this input into consideration in future years. j. MIPS Payment Adjustments (1) Final Score Used in Payment Adjustment Calculation For our previously established policies regarding the final score used in payment adjustment calculations, we refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77330 through 77332) and the CY 2018 Quality Payment Program final rule (82 FR 53785 through 53787). Under our policies, for groups submitting data using the TIN identifier, we will apply the group final score to all the TIN/NPI combinations that bill under that TIN during the performance period (82 FR 53785). We proposed to modify this policy for the application of the group final score, beginning with the 2019 E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations performance period/2021 MIPS payment year (83 FR 35971). We proposed a 15-month window that starts with the second segment of the MIPS determination period (October 1 prior to the MIPS performance period through September of the MIPS performance period) and also includes the final 3 months of the calendar year of the performance period (October 1 through December 31 of the performance period year) (83 FR 35971). We proposed for groups submitting data using the TIN identifier, we would apply the group final score to all of the TIN/NPI combinations that bill under that TIN during the proposed 15-month window (83 FR 35971). We stated that we believe that partially aligning with the second segment of the MIPS determination period creates consistency with our eligibility policies that informs a group or eligible clinician of who is eligible. We refer readers to the CY 2019 PFS proposed rule (83 FR 35884 through 35886) where we discuss our proposals related to MIPS determination periods. We noted that, if a MIPS eligible clinician’s TIN/NPI combination was not part of the group practice during the MIPS determination period, the TIN/ NPI combination would not be identified in our system at the start of the MIPS data submission period; however, if the MIPS eligible clinician qualifies to receive the group final score under our proposal, we would apply the group final score to the MIPS eligible clinician’s TIN/NPI combination as soon as the information becomes available. We solicited comments on the above proposal. Comment: One commenter supported the concept of assigning a group score to clinicians who are in a group during the final 3 months of the calendar year of the performance period, stating that it is administratively burdensome for large organizations to track clinicians who join their practice during the last 3 months of the calendar year of the performance period and determine whether or not their previous practice intends to submit data on their behalf for the same calendar year of the performance period. Response: We thank the commenter for their support. Comment: One commenter expressed concern with the 15-month gap between the end of the first segment of the MIPS determination period and the end of the calendar year of the MIPS performance period for clinicians in groups who qualify for a group final score. The commenter stated that many clinicians move from one TIN to another and recommended we allow groups to report both on behalf of individual clinicians VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 or as a group for all clinicians who have assigned their billing rights to the TIN during the calendar year of the performance period. Response: We realize that the first segment of the MIPS determination period, as codified in this final rule at § 414.1305, ends 15 months before the end of the calendar year of the performance period; however, we believe the performance of a group should coincide, to the extent possible, with clinicians who are in the group during the performance period. Therefore, we believe it is appropriate to use the 15-month window which includes the second segment of the MIPS determination period and the last 3 months of the calendar year of the performance period. We note that group reporting is an option and practices may elect to submit for individual eligible clinicians, rather than as a group, as long as eligible clinicians are identified prior to end of the second segment of the MIPS determination period. As discussed in section III.I.3.i.(2)(b)(ii)(C) of this final rule, we do not have the ability to accept data for new group practices formed in the last 3 months of the calendar year of the performance period, or for individual MIPS eligible clinicians who switch practices in the last 3 months of the calendar year of the performance period if their new practice is not participating in MIPS as a group. Comment: One commenter did not support the proposed 15-month window, citing the need for additional clarity and guidance to avoid complexity and confusion, and suggested that CMS provide examples of how this policy would apply in different scenarios. This commenter also recommended that CMS consider the implications of the proposal on clinician employment and how the proposal may negatively impact the ability of clinicians to switch practices. Response: We do not agree that this proposal would cause confusion or add complexity. We believe the 15-month window aligns with our eligibility policies and better informs clinicians about their eligibility, streamlining the program. For example, for the 2019 MIPS performance period, if an eligible clinician joins a group practice in November of 2019 and that group practice existed prior to the last 3 months of the year (that is, prior to October 1, 2019) and submits MIPS data as a group, we would apply the group final score to that eligible clinician if the clinician bills under the group’s TIN during the proposed 15-month window. Another example is a MIPS eligible clinician who joins a group practice in October of 2018 and that group practice PO 00000 Frm 00045 Fmt 4701 Sfmt 4700 59879 submits MIPS data as a group for the 2019 MIPS performance period; for the 2019 performance period, we would apply the group final score to that eligible clinician if the clinician bills under the group’s TIN during the proposed 15-month window. We appreciate the suggestion to consider the policy’s implications on clinician employment and will take this into consideration in future rulemaking. After consideration of the comments we received, we are finalizing our proposed 15-month window that starts with the second segment of the MIPS determination period (October 1 prior to the calendar year of the performance period through September 30 of the calendar year of the performance period) and also includes the final 3 months of the calendar year of the performance period (October 1 through December 31 of the calendar year of the performance period). We are also finalizing that for groups submitting data using the TIN identifier, we will apply the group final score to all of the TIN/NPI combinations that bill under that TIN during the 15-month window. We refer readers to section III.I.3.i.(2)(b)(ii)(C) of this final rule for a detailed discussion of the reweighting of the quality, cost, improvement activities and Promoting Interoperability performance categories for MIPS eligible clinicians who join a group practice in the final 3 months of the calendar year of the performance period. (2) Establishing the Performance Threshold Under section 1848(q)(6)(D)(i) of the Act, for each year of MIPS, the Secretary shall compute a performance threshold with respect to which the final scores of MIPS eligible clinicians are compared for purposes of determining the MIPS payment adjustment factors under section 1848(q)(6)(A) of the Act for a year. The performance threshold for a year must be either the mean or median (as selected by the Secretary, and which may be reassessed every 3 years) of the final scores for all MIPS eligible clinicians for a prior period specified by the Secretary. Section 1848(q)(6)(D)(iii) of the Act included a special rule for the initial 2 years of MIPS, which requires the Secretary, prior to the performance period for such years, to establish a performance threshold for purposes of determining the MIPS payment adjustment factors under section 1848(q)(6)(A) of the Act and an additional performance threshold for purposes of determining the additional MIPS payment adjustment factors under section 1848(q)(6)(C) of the Act, each of E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59880 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations which shall be based on a period prior to the performance period and take into account data available for performance on measures and activities that may be used under the performance categories and other factors determined appropriate by the Secretary. Section 51003(a)(1)(D) of the Bipartisan Budget Act of 2018 amended section 1848(q)(6)(D)(iii) of the Act to extend the special rule to apply for the initial 5 years of MIPS instead of only the initial 2 years of MIPS. In addition, section 51003(a)(1)(D) of the Bipartisan Budget Act of 2018 added a new clause (iv) to section 1848(q)(6)(D) of the Act, which includes an additional special rule for the third, fourth, and fifth years of MIPS (the 2021 through 2023 MIPS payment years). This additional special rule provides, for purposes of determining the MIPS payment adjustment factors under section 1848(q)(6)(A) of the Act, in addition to the requirements specified in section 1848(q)(6)(D)(iii) of the Act, the Secretary shall increase the performance threshold for each of the third, fourth, and fifth years to ensure a gradual and incremental transition to the performance threshold described in section 1848(q)(6)(D)(i) of the Act (as estimated by the Secretary) with respect to the sixth year (the 2024 MIPS payment year) to which the MIPS applies. To determine a performance threshold to propose for the third year of MIPS (2019 MIPS performance period/2021 MIPS payment year), in the CY 2019 PFS proposed rule (83 FR 35971), we again relied upon the special rule in section 1848(q)(6)(D)(iii) of the Act, as amended by 51003(a)(1)(D) of the Bipartisan Budget Act of 2018. As required by section 1848(q)(6)(D)(iii) of the Act, we considered data available from a prior period with respect to performance on measures and activities that may be used under the MIPS performance categories. In accordance with newly added clause (iv) of section 1848(q)(6)(D) of the Act, we also considered which data could be used to estimate the performance threshold for the 2024 MIPS payment year to ensure a gradual and incremental transition from the performance threshold we would establish for the 2021 MIPS payment year. In the CY 2019 PFS proposed rule (83 FR 35971), we noted that we considered using the final scores for the 2017 MIPS performance period/2019 MIPS payment year; however, the data used to calculate the final scores was submitted through the first quarter of 2018, and final scores for MIPS eligible clinicians were not available in time for us to use in our VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 analyses. We noted that if technically feasible, we would consider using the actual data used to determine the final scores for the 2019 MIPS payment year to estimate a performance threshold for the 2024 MIPS payment year in the final rule. Because the final scores for MIPS eligible clinicians were not yet available at the time of the CY 2019 PFS proposed rule, we reviewed the data relied upon for the CY 2017 Quality Payment Program final rule regulatory impact analysis (81 FR 77514 through 77536) as we believed it was the best data available to us to estimate the actual data for the 2017 MIPS performance period/2019 MIPS payment year (83 FR 35971). Please refer to the CY 2019 PFS proposed rule (83 FR 35971 through 35973) for more details about the data we used. In accordance with section 1848(q)(6)(D)(i) of the Act, the performance threshold for the 2024 MIPS payment year would be either the mean or median of the final scores for all MIPS eligible clinicians for a prior period specified by the Secretary. In the CY 2019 PFS proposed rule (83 FR 35972), we stated that when we analyzed the estimated final scores for the first year of the program (the 2019 MIPS payment year), the mean final score was between 63.50 and 68.98 points and the median was between 77.83 and 82.5 points based on the different participation assumptions. For purposes of estimating the performance threshold for the 2024 MIPS payment year, we used the mean final score based on data used for the CY 2017 Quality Payment Program final rule regulatory impact analysis (81 FR 77514 through 77536), which resulted in an estimated performance threshold between 63.50 and 68.98 points for the 2024 MIPS payment year. We noted that this is only an estimation we are providing in accordance with section 1848(q)(6)(D)(iv) of the Act, and we will propose the actual performance threshold for the 2024 MIPS payment year in future rulemaking. We proposed a performance threshold of 30 points for the 2021 MIPS payment year to be codified at § 414.1405(b)(6) (83 FR 35972). A performance threshold of 30 points would be a modest increase over the performance threshold for the 2020 MIPS payment year (15 points), and we stated that we believe it would provide a gradual and incremental transition to the performance threshold we will establish for the 2024 MIPS payment year, which we have estimated would be between 63.50 and 68.98 points. PO 00000 Frm 00046 Fmt 4701 Sfmt 4700 We stated that we want to encourage continued participation and the collection of meaningful data by MIPS eligible clinicians. A higher performance threshold would help MIPS eligible clinicians strive to achieve more complete reporting and better performance and prepare MIPS eligible clinicians for the 2024 MIPS payment year. However, a performance threshold set too high could also create a performance barrier, particularly for MIPS eligible clinicians who did not previously participate in PQRS or the EHR Incentive Programs. Additionally, we stated that we believe a modest increase from the performance threshold for the 2020 MIPS payment year would be particularly important to reduce the burden for MIPS eligible clinicians in small or solo practices. We stated that we believe that active participation of MIPS eligible clinicians in MIPS will improve the overall quality, cost, and care coordination of services provided to Medicare beneficiaries. In the CY 2019 PFS proposed rule (83 FR 35972), we noted that we heard from stakeholders requesting that we continue a low performance threshold and from stakeholders that requested we ramp up the performance threshold to help MIPS eligible clinicians prepare for a future performance threshold of the mean or median of final scores and to meaningfully incentivize higher performance. We also noted that we heard from stakeholders who stated a higher performance threshold may incentivize higher performance by MIPS eligible clinicians through higher positive MIPS payment adjustments for those who exceed the performance threshold. We noted our belief that a performance threshold of 30 points for the 2021 MIPS payment year would provide a gradual and incremental increase from the performance threshold of 15 points for the 2020 MIPS payment year and could incentivize higher performance by MIPS eligible clinicians. We also noted our belief that a performance threshold of 30 points represents a meaningful increase compared to 15 points, while maintaining flexibility for MIPS eligible clinicians in the pathways available to achieve this performance threshold, and we provided examples to support our belief in the CY 2019 PFS proposed rule (83 FR 35972). We invited public comment on the proposal to set the performance threshold for the 2021 MIPS payment year at 30 points (83 FR 35972). Alternatively, we considered whether the performance threshold should be set at a higher or lower number, for example, 25 points or 35 points, and also sought comment on E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations alternative numerical values for the performance threshold for the 2021 MIPS payment year (83 FR 35972). We solicited comments on the above proposal. Comment: Many commenters supported the proposed performance threshold of 30 points, indicating that the increase is reasonable; is aligned with what they believe to be Congress’s intent to ensure that clinicians continue to be held accountable for quality and cost; is not a significant change from the prior year; encourages clinicians to increase their engagement and performance in MIPS; and is low enough to protect eligible clinicians who may not have experience reporting in MIPS from negative payment adjustments. One commenter stated that raising the performance threshold may help limit the flattening impact of the overall cost performance category score. One commenter stated the modest increase would not disadvantage small practices if the small practice bonus and other special scoring policies remain available to them and is reasonable considering that a fair portion of clinicians are excluded from MIPS under the low-volume threshold. Response: We thank the commenters for their support. Comment: Many commenters did not support the proposed performance threshold of 30 points and stated it is too high, is not gradual enough, would be unduly taxing, and many eligible clinicians are still adapting to the complexities of the MIPS program. Several commenters did not support the performance threshold citing the number of policy changes to the MIPS program and stated that group practices and clinicians, including newly eligible clinicians, should gain experience with MIPS policy changes, including changes to episode-based cost measures and the restructuring of the Promoting Interoperability performance category, before the performance threshold is raised. Several commenters recommended a performance threshold of 20 points given the number of changes being proposed. Commenters also indicated 20 points would help newly eligible clinicians adjust to program reporting requirements and that it could be met or exceeded by reporting on 6 quality measures that receive at least 3 points per measure and one high weighted improvement activity or 2 medium weighted improvement activities to avoid a negative MIPS payment adjustment. A few commenters indicated that clinicians need more time to be educated about the MIPS program. Response: We acknowledge the concerns submitted by many VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 commenters. We recognize that many requirements and scoring policies in the MIPS program have changed since the 2017 MIPS performance period/2019 MIPS payment year, but we believe the proposed performance threshold of 30 points is an appropriate increase that encourages increased participation and engagement in the MIPS program and that incentivizes clinicians to transition to value-based care with a focus on the delivery of high-value care. We also do not believe that increasing the performance threshold to 30 points is unreasonable or too steep, but is rather a moderate step that encourages clinicians to gain experience with all MIPS performance categories. In the CY 2019 PFS proposed rule, we estimated the performance threshold we would establish for the 2024 MIPS payment year would be between 63.50 and 68.98 points. This information was based on year 1 estimates from the regulatory impact analysis (83 FR 35972; 81 FR 77514 through 77536). When we looked at the actual final scores for MIPS eligible clinicians for the 2017 MIPS performance period/2019 MIPS payment year, we found the mean final score was 74.01 points and the median final score was 88.97 points. As discussed in section VII.F.8.d. of the Regulatory Impact Analysis (RIA) of this final rule, we also estimated the potential final scores for the 2019 MIPS performance period/2021 MIPS payment year. In the RIA, we updated our estimates by using data submitted for the first year of MIPS (2017 MIPS performance period/2019 MIPS payment year) and applying the scoring and eligibility policies for the third year of MIPS (the 2019 MIPS performance period/2021 MIPS payment year). In the RIA, we estimated the mean final score for the 2019 performance period/2021 MIPS payment year at 69.53 points and the median final score at 78.72 points. Based on these numbers, we estimate the performance threshold that we would establish for the 2024 MIPS payment year would likely be over 65 points. We believe that if we set the performance threshold at 20 points (or another number lower than 30 points) for the 2021 MIPS payment year, then the increases in the performance threshold for each of the 2022 and 2023 MIPS payment years would have to be steeper to ensure a gradual and incremental transition to the performance threshold for the 2024 MIPS payment year, in accordance with 1848(q)(6)(D)(iv) of the Act. Additionally, we recognize that some policy changes, such as those finalized in this final rule for the Promoting Interoperability performance category, PO 00000 Frm 00047 Fmt 4701 Sfmt 4700 59881 the impact of topped out measures on the quality performance category, the increased weighting of the cost performance category, and the introduction of episode-based cost measures may dampen final scores because it will be more difficult to achieve a perfect performance category score of 100 percent. However, we believe there are also many options for a MIPS eligible clinician, including a newly eligible clinician, to earn a final score at or above a performance threshold of 30 points that do not require a perfect score in every performance category and that these policies do not preclude a MIPS eligible clinician from performing well. For example, a MIPS eligible clinician that submits the maximum number of improvement activities (achieving 40 points out of a possible 40 points) that is weighted at 15 percent of the final score (100 percent improvement activities performance category score × 15 percent × 100 equals 15 points toward the final score) and achieves a quality performance category score of 35 percent 31 that could be achieved through a minimum of complete reporting of quality measures at varying levels of performance (35 percent quality performance category score × 45 percent × 100 equals 15.75 points toward the final score) would qualify for 30.75 points and exceed the performance threshold. When we also consider the cost and Promoting Interoperability performance categories scores, clinicians have even more options to exceed a 30-point performance threshold. While the performance threshold could be met or exceeded without clinician participation in the quality performance category, we encourage clinicians to participate in multiple performance categories, including the quality performance category, to help facilitate successful participation in MIPS when the performance threshold will be increased in future years and to align with the MIPS program’s focus on value-based care and the delivery of high quality care for Medicare beneficiaries. We agree with commenters about the need to educate clinicians, including newly eligible clinicians, about MIPS program policies and policy changes from year to year and encourage 31 The score for the quality performance category would be (6 measure achievement points × 1 measure plus 3 measure achievement points × 5 measures)/60 total possible achievement points or 35 percent. This assumes an outcome measure is submitted. That score could be higher if the clinician qualifies for bonuses in the quality performance category. E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59882 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations clinicians to utilize the resources available to educate clinicians about the MIPS program at the CMS Quality Payment Program Resource library at https://www.cms.gov/Medicare/QualityPayment-Program/Resource-Library/ Resource-library.html. Comment: Several commenters recommended a lower performance threshold specifically for eligible clinicians in their first year of MIPS eligibility, citing that this flexibility is more equitable and allows for a greater chance of successful participation, is a reasonable approach, and that 30 points creates an unlevel playing field. A few commenters recommended 25 points and other scoring accommodations for newly eligible clinicians, including occupational therapists and physical therapists. A few commenters suggested alternative performance thresholds for newly eligible clinicians including 3 points and a modified ‘‘pick your pace’’ threshold for these clinicians. One commenter recommended a performance threshold of 20 points and stated a 30-point performance threshold is a very high standard for eligible clinicians in their first year of eligibility. Response: As described in section III.I.3.j.(2) of this final rule, the MIPS program is still ramping up, and we will continue to increase the performance threshold to ensure a gradual and incremental transition to the performance threshold for the 2024 MIPS payment year (year 6). Therefore, a clinician who is a MIPS eligible clinician beginning with the 2021 MIPS payment year would have 4 years in the program to ramp up to year 6. Conversely, a clinician who first becomes a MIPS eligible clinician in a later year would be afforded less time to ramp up the closer the program gets to year 6. We refer readers to section III.I.3.a. of this final rule for our discussion of new eligible clinician types. Comment: Many commenters stated that CMS should not increase the performance threshold until there is actual MIPS participation data available to analyze and share with clinicians, indicating that there is insufficient historical MIPS data on which to set benchmarks and determine the feasibility of the current performance threshold, the program is still in its early stages, and that use of actual data would provide eligible clinicians a greater sense of how they performed in the program overall. Response: We appreciate the commenters’ concerns with the proposed performance threshold and their request for a delay in increasing the performance threshold until we VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 have more information about how clinicians are actually performing under MIPS. As discussed earlier in this section, we estimate that we would likely set the performance threshold for the 2024 MIPS payment year at over 65 points. We did analyze the actual final scores for the 2019 MIPS payment year and found the mean final score was 74.01 points and the median final score was 88.97 points for MIPS eligible clinicians. We believe that setting the performance threshold at 30 points for the 2019 performance period/2021 MIPS payment year is appropriate because it encourages increased participation and prepares clinicians for the additional participation requirements to meet or exceed the performance thresholds that will be set for later years. Additionally, we do not believe that keeping the performance threshold at 15 points (which was the performance threshold for the 2020 MIPS payment year) would provide the gradual and incremental transition to the performance threshold for the 2024 MIPS payment year required by section 1848(q)(6)(D)(iv) of the Act. We also note that eligible clinicians have received performance feedback based on their performance in year 1 of MIPS. As previously finalized in the CY 2018 Quality Payment Program final rule (82 FR 53801 through 53802), on an annual basis, beginning July 1, 2018, performance feedback will be provided to MIPS eligible clinicians and groups for the quality and cost performance categories for the 2017 performance period, and if technically feasible, for the improvement activities and advancing care information (now known as Promoting Interoperability) performance categories. For details on the release of the feedback reports for the first year of MIPS, we refer readers to section III.I.3.g. of this final rule. Comment: Several commenters did not support the proposed performance threshold of 30 points, stating their belief that it burdens smaller practices, especially individual clinicians who are unable to afford CEHRT. A few commenters recommended that CMS consider a bonus for solo practitioners. Response: We acknowledge the concerns of commenters regarding the potential burden on small practices, particularly solo practitioners. We also recognize the unique challenges for solo practitioners who participate in MIPS and have established a set of policies for small practices that apply to solo practitioners as well. The special policies available for small practices include the small practice bonus which is finalized in section III.I.3.i.(1)(b)(viii) of this final rule; the provisions related PO 00000 Frm 00048 Fmt 4701 Sfmt 4700 to the assignment of 3 points for measures that do not meet data completeness criteria which are finalized in section III.I.3.i.(1)(b)(v) of this final rule; the significant hardship exception for Promoting Interoperability performance category and the associated reweighting policies available for small practices (CY 2018 Quality Payment Program final rule (82 FR 53683)); and special scoring provisions available for the improvement activities performance category (81 FR 77185, 77188; 82 FR 53656. We also note that clinicians in small practices are more likely than clinicians in larger practices to fall below one of the low-volume criteria and would not be required to submit to MIPS; however, if they exceed at least one, but not all, of the low volume criteria, then they would be able to take advantage of the opt-in policy. We refer readers to section III.I.3.c. of this final rule for more details. Comment: A few commenters recommended a more modest increase to the performance threshold and asked us to consider specialty-specific performance thresholds, or special scoring policies for clinicians in specialty practices, stating this would allow for more fair comparisons among clinicians. One commenter stated concerns with ambulatory surgical center-based clinicians being able to meet a 30-point threshold and requested that CMS consider scoring relief for ambulatory surgical center-based clinicians and groups. One commenter stated concerns for certified registered nurse anesthetists (CRNAs) meeting the performance threshold, citing the lack of anesthesia-related measures, low achievable points due to quality measure benchmarking, the lack of applicable cost measures, and the inability of CRNAs to participate in the Promoting Interoperability performance category that places a significant amount of time, money and resources into achieving performance scores to meet the minimum performance threshold. One commenter did not support the proposed performance threshold and believed that clinicians who are not capable of submitting data for more than one MIPS performance category could not meet the performance threshold. Response: We appreciate the unique challenges faced by MIPS eligible clinicians that are in specialty practices, including clinicians based in ambulatory surgical centers and CRNAs. However, we believe that different performance criteria for certain types of clinicians would create more confusion and burden than a cohesive set of criteria. We also do not believe the E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations proposed increase in the performance threshold is overly aggressive or unfair to specialty practices and note that there are multiple pathways for clinicians, including specialty practices, to meet or exceed the performance threshold. We also believe that except for a few circumstances, such as extreme and uncontrollable circumstances, rare cases where there are no quality measures, or clinicians joining an existing practice (existing TIN) during the final 3 months of the calendar year in which the performance period occurs (the performance period year) that is not participating in MIPS as a group, most MIPS eligible clinicians would have sufficient measures and activities available and applicable to them for the quality and improvement activities performance categories and would be scored on these two categories. We also have policies in place, such as data validation process discussed in section III.I.3.i.(1)(b)(vii) of this final rule, to assess if clinicians have fewer than 6 measures available and applicable for the quality performance category. We refer the readers to the discussion of our reweighting policies for extreme and uncontrollable circumstances at section III.I.3.i.(2)(b)(ii) of this final rule. Comment: A few commenters supported keeping a performance threshold of 15 points to minimize administrative burdens as part of the ‘‘Patients over Paperwork’’ initiative and to give clinicians adequate time to adjust their practice to meet the program’s requirements. Response: We are mindful of the efforts and requirements for eligible clinician participation in MIPS and agree that many clinicians need time to become familiar with the program’s policies and requirements and gain experience with increased participation under the MIPS program. However, we do not believe that maintaining the performance threshold at 15 points for the 2019 performance period/2021 MIPS payment year appropriately encourages clinicians to actively participate in MIPS and incentivizes clinicians to transition to value-based care with a focus on the delivery of high-value care. Additionally, we do not believe that keeping the performance threshold at 15 points (which was the performance threshold for the 2020 MIPS payment year) would provide the gradual and incremental transition to the performance threshold for the 2024 MIPS payment year that the statute requires. We believe a meaningful increase to a performance threshold of 30 points maintains appropriate flexibility for clinicians to meet or exceed the performance threshold, VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 while requiring increased participation over the level of engagement required to meet or exceed the 15-point threshold for year 2 of MIPS. We also believe the increased participation better prepares clinicians to succeed under MIPS in future years, will encourage a transition to the MIPS program’s focus on valuebased care, and will improve the overall quality, cost, and care coordination of services to Medicare beneficiaries. Comment: Several commenters recommended a higher performance threshold believing that the proposed performance threshold punishes eligible clinicians who have invested time and money to achieve high MIPS performance, compromises the ability of high performers to earn the maximum payment adjustment, and dilutes program effectiveness to drive quality improvement and reduce spending growth. A few commenters recommended a performance threshold between 30 points and 60 points. One commenter recommended a performance threshold of 50 points, stating it would better reward clinicians and groups who are engaged with the program and encourage the examination of alternative payment models. Response: The MIPS statute requires budget neutrality, and clinicians will receive a positive, negative, or neutral payment adjustment factor that is determined by their performance and the distribution of final scores across all MIPS eligible clinicians; accordingly, high performers would likely receive higher payment adjustments if fewer MIPS eligible clinicians meet or exceed the performance threshold. While a higher performance threshold provides a greater financial reward for high performers, we believe the proposal of 30 points is warranted to encourage clinician participation in MIPS and to encourage a movement toward valuebased care with a focus on the delivery of high quality care. We also believe that the additional performance threshold for exceptional performance discussed later in section III.I.3.j.(3) of this final rule provides an additional financial incentive and financial reward for high performers and will continue to incentivize their exceptional performance. Moreover, we believe setting the performance threshold higher than 30 points would not provide a gradual and incremental transition to the performance threshold for the 2024 MIPS payment year, as required by the statute, but rather would result in a sharp increase over the performance threshold of 15 points for the 2020 MIPS payment year. After consideration of the comments, we are finalizing our proposal to set the PO 00000 Frm 00049 Fmt 4701 Sfmt 4700 59883 performance threshold at 30 points for the 2021 MIPS payment year as proposed. We are codifying the performance threshold for the 2021 MIPS payment year and finalizing the regulation text at § 414.1405(b)(6) as proposed. We also solicited comment on our approach to estimating the performance threshold for the 2024 MIPS payment year, which in the CY 2019 PFS proposed rule we based on the estimated mean final score for the 2019 MIPS payment year (83 FR 35972). We were particularly interested in whether we should use the median, instead of the mean, and whether in the future we should estimate the mean or median based on the final scores for another MIPS payment year. We also solicited comment on whether establishing a path forward to a performance threshold for the 2024 MIPS payment year that provides certainty to clinicians and ensures a gradual and incremental increase from the performance threshold for the 2021 MIPS payment year to the estimated performance threshold for the 2024 MIPS payment year would be beneficial, and whether it would be beneficial for MIPS eligible clinicians to know in advance the performance threshold for the 2022 and 2023 MIPS payment years to encourage and facilitate increased clinician engagement and prepare clinicians for meeting the performance threshold for the 2024 MIPS payment year. We thank commenters for their input on these topics and will take this input into consideration in future years. (3) Additional Performance Threshold for Exceptional Performance Section 1848(q)(6)(D)(ii) of the Act requires the Secretary to compute, for each year of the MIPS, an additional performance threshold for purposes of determining the additional MIPS payment adjustment factors for exceptional performance under section 1848(q)(6)(C) of the Act. For each such year, the Secretary shall apply either of the following methods for computing the additional performance threshold: (1) The threshold shall be the score that is equal to the 25th percentile of the range of possible final scores above the performance threshold determined under section 1848(q)(6)(D)(i) of the Act; or (2) the threshold shall be the score that is equal to the 25th percentile of the actual final scores for MIPS eligible clinicians with final scores at or above the performance threshold for the prior period described in section 1848(q)(6)(D)(i) of the Act. Under section 1848(q)(6)(C) of the Act, a MIPS eligible clinician with a E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59884 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations final score at or above the additional performance threshold will receive an additional MIPS payment adjustment factor and may share in the $500,000,000 of funding available for the year under section 1848(q)(6)(F)(iv) of the Act. As we discussed in the CY 2019 PFS proposed rule (83 FR 35971), we relied on the special rule under section 1848(q)(6)(D)(iii) of the Act, as amended by section 51003(a)(1)(D) of the Bipartisan Budget Act of 2018, to propose a performance threshold of 30 points for the 2021 MIPS payment year. The special rule under section 1848(q)(6)(D)(iii) of the Act also applies for purposes of establishing an additional performance threshold for a year. For the 2021 MIPS payment year, we proposed to again decouple the additional performance threshold from the performance threshold (83 FR 35973 through 35974). During the time period in which we were drafting the CY 2019 PFS proposed rule, we did not have actual MIPS final scores for a prior performance period. We noted in the CY 2019 PFS proposed rule (83 FR 35973) that if we did not decouple the additional performance threshold from the performance threshold, then we would have to set the additional performance threshold at the 25th percentile of possible final scores above the performance threshold. With a performance threshold set at 30 points, the range of total possible points above the performance threshold is 30.01 to 100 points and the 25th percentile of that range is 47.5, which is less than one-half of the possible 100 points in the MIPS final score. We stated that we do not believe it would be appropriate to lower the additional performance threshold to 47.5 points because we do not believe a final score of 47.5 points demonstrates exceptional performance by a MIPS eligible clinician, as these additional incentives should only be available to those clinicians with very high performance on the MIPS measures and activities. Therefore, we relied on the special rule under section 1848(q)(6)(D)(iii) of the Act and proposed at § 414.1405(d)(5) to set the additional performance threshold at 80 points for the 2021 MIPS payment year, which is higher than the 25th percentile of the range of the possible final scores above the performance threshold (83 FR 35973). As required by section 1848(q)(6)(D)(iii) of the Act, we took into account the data available and the modeling described in the CY 2019 PFS proposed rule to estimate final scores for the 2021 MIPS payment year (83 FR 35973). We stated that we believed 80 VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 points was appropriate to incentivize clinicians who have made greater strides to meaningfully participate in the MIPS program to perform at even higher levels. An additional performance threshold of 80 points would require a MIPS eligible clinician to perform well on at least two performance categories. We stated that, generally, a MIPS eligible clinician could receive a maximum score of 45 points for the quality performance category, which is below the 80-point additional performance threshold. In addition, 80 points is at a high enough level that MIPS eligible clinicians must submit data for the quality performance category to achieve this target. We noted the additional performance threshold at 80 points could increase the incentive for excellent performance while keeping the focus on quality performance. We also stated an increase would encourage increased engagement and further incentivize clinicians whose performance meets or exceeds the additional performance threshold, recognizing that a fixed amount is available for a year under section 1848(q)(6)(F)(iv) of the Act to fund the additional MIPS payment adjustments and that the more clinicians who receive an additional MIPS payment adjustment, the lower the average clinician’s additional MIPS payment adjustment will be. For future years, we stated that we may consider additional increases to the additional performance threshold. We solicited comments on these proposals. Comment: Many commenters recommended the additional performance threshold remain at 70 points. Several commenters stated it would be more difficult to reach 80 points rather than 70 points because of proposed changes to the Promoting Interoperability performance category, changes to quality measures, more topped out measures, the increased weighting of the cost performance category, the introduction of episodebased cost measures, and the removal of bonus points. One commenter recommended that the additional performance threshold remain at 70 points for at least another year because clinicians are still learning to interpret their feedback reports and make adjustments to their practices accordingly. One commenter stated that clinicians in specialty practices without a significant breadth of reportable measures would be adversely affected while those specialties that do have large numbers of measures with full scoring potential would benefit and that this was unfair and would discourage PO 00000 Frm 00050 Fmt 4701 Sfmt 4700 high performance for those clinicians and groups within specialties. One commenter indicated that the increase may cause more clinicians to report on measures that bring more points rather than the most value to their patients and practice. Another commenter stated the increase seemed arbitrary and that clinicians who earn 70 points should be considered exceptional. One commenter stated that keeping the additional performance threshold at 70 points would allow the payment adjustment to be spread more evenly rather than to only a select few and alleviate some of the lack of positive payment adjustment incentive due to the very low 30-point performance threshold. A few commenters stated the additional performance threshold should not be increased until information is available and data shared with clinicians from the first 2 years of the program about the number of eligible clinicians who were able to earn the additional payment adjustment, including the number of psychiatrists who exceeded the additional performance threshold during the 2017 MIPS performance period. Response: We note that many commenters recommended that we maintain 70 points for the additional performance threshold for the 2019 performance period/2021 MIPS payment year. However, we believe for year 3 it is appropriate to raise the bar on what is rewarded as exceptional performance and that increasing the additional performance threshold will encourage clinicians to increase their focus on value-based care and enhance the delivery of high quality care for Medicare beneficiaries. Based on our current data, our belief that raising the additional performance threshold will incentivize continued improved performance, and our concern that policy changes may make it challenging for clinicians to reach an additional performance threshold of 80 points while they are becoming familiar and comfortable with the policy changes, we believe it is important to raise the additional performance threshold, but by less than the original amount proposed. Therefore, for year 3 of the MIPS program, we are finalizing the additional performance threshold at 75 points, which is halfway between our proposal of 80 points and the level recommended by many commenters of 70 points. We appreciate commenters’ concerns about the proposed policy changes for MIPS impacting clinicians’ ability to exceed the additional performance threshold. While we recognize that some of the policy changes being E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations finalized in this rule, including new scoring policies for the Promoting Interoperability performance category, changes to quality measures, the identification of more topped out measures, the increased weighting of the cost performance category, and the introduction of episode-based cost measures, may make it more challenging for clinicians to achieve higher scores while they are becoming more familiar and comfortable with these new policies, we also believe these policy changes help simplify and streamline the MIPS program and reduce overall burden after an initial adjustment period. Thus, we believe it is appropriate to slightly increase the additional performance threshold for year 3 and will consider raising it more in future years. In addition, despite these changes, we believe that 75 points is achievable for many clinicians. Based on our most current data, we estimated for the 2019 performance period/2021 MIPS payment year a mean final score of 69.53 points and a median final score of 78.72 points as discussed elsewhere in this section and in section VII.F.8.d. of the RIA of this final rule. We also believe a modest increase above the additional performance threshold for the 2018 MIPS performance period/2020 MIPS payment year would result in an additional performance threshold that is attainable and that would allow for multiple pathways for clinicians, including clinicians in specialty practices whose choice of applicable and available measures will likely vary according to specialty, to perform exceptionally well and would encourage higher performance by clinicians for year 3 of the MIPS program. We acknowledge that the number of quality measures available to clinicians can vary by specialty and practice. We believe our quality performance category scoring validation policy accounts for certain instances where clinicians have less than 6 measure available. We believe these adjustments allow us to develop a fair comparison across different MIPS eligible clinicians and would not preclude clinicians from reaching the final additional performance threshold. We also note that we have shared performance feedback with clinicians and groups based on their performance in year 1 of MIPS and recognize that clinicians may make adjustments to their clinical practice in response to that feedback, and because we are trying to balance that year 3 is a transition year with the goal of encouraging clinicians to improve their performance and to deliver value-based, high quality care, VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 we believe that a moderate increase to 75 points is appropriate. Comment: Many commenters supported the proposal to increase the additional performance threshold for exceptional performance to 80 points for the 2021 MIPS payment year and stated it encourages strong performance from clinicians and health systems, supports continuous performance improvement, motivates and holds clinicians accountable to deliver quality care, creates a competitive playing field for high performers, rewards clinicians who have invested time and resources and have demonstrated success under MIPS performance standards, seems reasonable, and is an appropriate increase for year 3 of the program. One commenter supported the proposal because it ensures clinicians are considering both cost and quality. One commenter stated that raising the threshold may help with flattening the overall cost performance score. One commenter supported the proposal because it is high enough to identify exceptional scores, but was uncertain if it would translate into improved patient outcomes or would meet CMS objectives. One commenter supported the proposal should CMS continue its policies that provide bonus points in the MIPS program and allow for claimsbased reporting. Response: We received many comments in support of our proposal for an additional performance threshold of 80 points. We agree with the commenters that raising the performance threshold encourages strong clinician performance, participation in multiple performance categories, and continuous performance improvement; provides an appropriate financial reward for high performers; and promotes a focus on the delivery of high quality, value-based care by clinicians. We also note that there were many commenters recommending that the additional performance threshold remain at 70 points and other commenters recommending 75 points. We have considered the totality of the comments and are swayed by the comments requesting a more modest increase to the additional performance threshold. We have also considered the updated regulatory impact analysis which incorporates Quality Payment Program year 1 data to estimate performance for the 2019 performance period/2021 MIPS payment year in section VII.F.8.d. of this final rule and found a mean score of 69.53 points and a median final score of 78.72 points. Given these findings, we believe that a small decrease from the proposed PO 00000 Frm 00051 Fmt 4701 Sfmt 4700 59885 additional performance threshold of 80 points that would fall between the mean and the median would help the additional performance threshold remain attainable and would allow for a larger number of clinicians to receive the additional payment adjustment. We also believe an increase in the additional performance threshold would incentivize clinicians to increase their focus on value-based care with an emphasis on the delivery of high quality care for patients, but that an increase of 10 points is too steep, and thus, are finalizing an additional performance threshold of 75 points that is midway between our original proposal of 80 points and the additional performance threshold for the 2018 MIPS performance period/2020 MIPS payment year of 70 points. Comment: A few commenters stated an increase to 80 points would disproportionately impact small practices and make it difficult for them to participate successfully in the MIPS program. One commenter recommended CMS should not increase the additional performance threshold until data was available to consider the impact on small practices and then set a fair threshold. Response: We recognize the unique challenges to eligible clinicians in small practices participating in MIPS and believe the special policies for small practices provide some relief for small practices seeking to perform well. We refer readers to special policies for small practices including: The small practice bonus which is finalized in section III.I.3.i.(1)(b)(viii) of this final rule; the significant hardship exception for the Promoting Interoperability performance category available for small practices (CY 2018 Quality Payment Program final rule 82 FR 53683); the special scoring provisions available for the improvement activities performance category (81 FR 77185, 77188; 82 FR 53656); and the provisions related to the assignment of 3 points for measures that do not meet data completeness criteria which are finalized in section III.I.3.i.(1)(b)(v) of this final rule). We also note that small practices are more likely than larger practices to fall below one or more of the provisions related to the low-volume threshold and would be able to take advantage of the opt-in policy and refer readers to a discussion of the low-volume threshold at section III.I.3.c. of this final rule. We also analyzed the data referenced in section VII.F.8.d. of the RIA of this final rule, and found that more small practices than larger practices may find it harder to meet or exceed the additional performance threshold. We E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59886 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations agree with commenters referenced here and elsewhere in this section that an additional performance threshold of 80 points is too steep of an increase from 70 points, but we believe that an increase is appropriate for year 3 and that the current policies that provide flexibilities for small practice provide a pathway for a successful transition for clinicians who have made a commitment toward value and the delivery of high quality care in the MIPS program. Based on these competing concerns, as noted above, we are finalizing an additional performance threshold of 75 points. We also note that the additional performance threshold rewards exceptional performance in the MIPS program and a clinician could successfully participate in MIPS by meeting or exceeding the performance threshold and receive a neutral or positive payment adjustment. Comment: A few commenters recommended 75 points because it is a more modest, 5-point increase from the previous performance threshold of 70 points. One commenter supported 75 points believing the increase seems fair because the threshold is more attainable for many eligible clinicians who are specialists, such as those practicing interventional pain management, who may have difficulty identifying relevant measures that improve patient quality of care. One commenter supported 75 points should CMS finalize its proposal to remove claims-based reporting and finalize its proposal to remove bonus points for improvement activities completed using CEHRT. Response: We agree with an additional performance threshold of 75 points. We believe for year 3 it is appropriate to raise the bar on what is rewarded as exceptional performance and that increasing the additional performance threshold will encourage clinicians to increase their focus on value-based care and promote the delivery of high quality care for patients. We also believe that a more modest increase of 5 points, rather than an increase of 10 points, over the additional performance threshold for year 2 is appropriate because year 3 is still a transition year and we want to encourage increased clinician engagement and increased performance in the MIPS program that drives toward the delivery of value-based, high quality care for Medicare beneficiaries. We also note that some commenters stated that the proposed 10-point increase may have unintended consequences especially because of the impact that proposed policy changes could have on final scores as clinicians are becoming VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 familiar with these changes. We want to reward exceptional performance that, given the impact of the policy changes in this final rule, could be less than 80 points. As such, we are swayed by comments that an increase to 75 points is more modest and a reasonable halfway point that still would raise the bar on what is rewarded as exceptional performance for the 2019 MIPS performance period. We note that a lower additional performance threshold could reduce the maximum additional payment adjustment that a MIPS eligible clinician could potentially receive if the funds available (up to $500 million for the year) are distributed over more clinicians that score above the lower additional performance threshold. For the reasons discussed above, we believe 75 points is appropriate for year 3 and note that the additional performance threshold will be raised in future years. Comment: A few commenters recommended a higher additional performance threshold for exceptional performers. One commenter recommended an additional performance threshold of 85 points to further efforts to engage clinicians and groups through financial incentives tied to metric performance. One commenter recommended a steeper scale for awarding exceptional performance for scores of 90 points or greater. Response: We believe that a steeper increase in the additional performance threshold is not appropriate given that MIPS is still in a transition period and because of the MIPS policy changes we are making in this final rule that include scoring changes to the Promoting Interoperability performance category and the addition of episode-based cost measures to the cost performance category, that could impact final scores for year 3 of the MIPS program as eligible clinicians become more familiar and comfortable with these policy changes. We want to reward exceptional performance that, given the impact of our policy changes in this final rule, could include performance below 85 or 90 points, particularly for small practices which may not have sufficient case minimum to achieve maximum quality performance category score. We recognize a higher additional performance threshold will allow for a higher financial reward for high performers, but we want to encourage participation with wider availability of this funding. Comment: One commenter recommended that CMS increase the thresholds in the CY 2020 performance period and going forward because higher thresholds will result in a wider PO 00000 Frm 00052 Fmt 4701 Sfmt 4700 array of payment adjustments, thereby encouraging more participation and rewarding those that invest in improving their quality of care. Response: We thank the commenter for the input and will take this comment into consideration in future rulemaking. After consideration of the comments, we are not finalizing our proposal of 80 points for the additional performance threshold and instead are finalizing 75 points for the additional performance threshold for the 2021 MIPS payment year. We are codifying the additional performance threshold for the 2021 MIPS payment year and finalizing the proposed regulation text at § 414.1405(d)(5) with modification to reflect 75 points instead of 80 points. (4) Application of the MIPS Payment Adjustment Factors (a) Application to the Medicare Paid Amount for Covered Professional Services In the CY 2018 Quality Payment Program final rule (82 FR 53795), we finalized the application of the MIPS payment adjustment factor, and if applicable, the additional MIPS payment adjustment factor, to the Medicare paid amount for items and services paid under Part B and furnished by the MIPS eligible clinician during the year. Sections 51003(a)(1)(A)(i) and 51003(a)(1)(E) of the Bipartisan Budget Act of 2018 amended sections 1848(q)(1)(B) and 1848(q)(6)(E) of the Act, respectively, by replacing the references to ‘‘items and services’’ with ‘‘covered professional services’’ (as defined in section 1848(k)(3)(A) of the Act). Covered professional services as defined in section 1848(k)(3)(A) of the Act are those services for which payment is made under, or is based on, the Medicare PFS and which are furnished by an eligible professional. As a result of these changes, the MIPS payment adjustment factor determined under section 1848(q)(6)(A), and as applicable, the additional MIPS payment adjustment factor determined under section 1848(q)(6)(C) of the Act, will be applied to Part B payments for covered professional services furnished by a MIPS eligible clinician during a year beginning with the 2019 MIPS payment year and not to Part B payments for other items and services. To conform with these amendments to the statute, we proposed to revise § 414.1405(e) to apply the MIPS payment adjustment factor and, if applicable, the additional MIPS payment adjustment factor, to the E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations amozie on DSK3GDR082PROD with RULES3 Medicare Part B paid amount for covered professional services furnished by a MIPS eligible clinician during a MIPS payment year (beginning with 2019) (83 FR 35973 through 35974). We also proposed to revise § 414.1405(e) to specify the formula for applying these adjustment factors in a manner that more closely tracks the statutory formula under section 1848(q)(6)(E) of the Act (83 FR 35973 through 35974). Specifically, we proposed the following formula: In the case of covered professional services (as defined in section 1848(k)(3)(A) of the Act) furnished by a MIPS eligible clinician during a MIPS payment year beginning with 2019, the amount otherwise paid under Part B with respect to such covered professional services and MIPS eligible clinician for such year, is multiplied by 1, plus the sum of: The MIPS payment adjustment factor divided by 100, and as applicable, the additional MIPS payment adjustment factor divided by 100 (83 FR 35974). We did not receive any comments on this proposal. We are finalizing our proposed changes to the regulation text at § 414.1405(e) as proposed. We also refer readers to section III.I.3.a. of this final rule where we discuss the covered professional services to which the MIPS payment adjustment could be applied. We also refer readers to section III.I.3.c.(3) of this final rule where we discuss other conforming edits to the regulation text at §§ 414.1310(a), 414.1310(b), and 414.1310(d) that specify the circumstances when the MIPS payment adjustment would not apply to payments for covered professional services furnished by MIPS eligible clinicians on or after January 1, 2019. (b) Application for Non-Assigned Claims for Non-Participating Clinicians In the CY 2018 Quality Payment Program final rule, we did not address the application of the MIPS payment adjustment for non-assigned claims for non-participating clinicians. In the CY 2018 Quality Payment Program final rule (82 FR 53795), we responded to a comment requesting guidance on how the MIPS payment adjustment and the calculation of the Medicare limiting charge amount would be applied for non-participating clinicians, and we stated our intention to address these issues in future rulemaking. Beginning with the 2019 MIPS payment year, we proposed that the MIPS payment adjustment does not apply for nonassigned claims for non-participating clinicians (83 FR 35974). This approach is consistent with the policy for VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 application of the value modifier that was finalized in the CY 2015 PFS final rule (79 FR 67950 through 67951). Sections 1848(q)(6)(A) and 1848(q)(6)(C) of the Act require that we specify a MIPS payment adjustment factor, and if applicable, an additional MIPS payment adjustment factor for each MIPS eligible clinician, and section 1848(q)(6)(E) of the Act (as amended by section 51003(a)(1)(E) of the Bipartisan Budget Act of 2018) requires that these payment adjustment factor(s) be applied to adjust the amount otherwise paid under Part B for covered professional services furnished by the MIPS eligible clinician during the MIPS payment year. When non-participating clinicians choose not to accept assignment for a claim, Medicare makes payment directly to the beneficiary, and the clinician collects payment from the beneficiary. This is referred to as a non-assigned claim. Application of the MIPS payment adjustment to these non-assigned claims would not affect payment to the MIPS eligible clinician. Rather, it would only affect Medicare payment to the beneficiary. If the MIPS payment adjustment were to be applied to nonassigned services, then the Medicare payment to a beneficiary would be increased when the MIPS payment adjustment is positive and decreased when the MIPS payment adjustment is negative. Although the statute does not directly address this situation, it does suggest that the MIPS payment adjustment is directed toward payment to the MIPS eligible clinician and the covered professional services they furnish. We continue to believe that it is important that beneficiary liability not be affected by the MIPS payment adjustment and that the MIPS payment adjustment should be applied to the amount that Medicare pays to MIPS eligible clinicians. On that basis, we proposed to apply the MIPS payment adjustment to claims that are billed and paid on an assignment-related basis, and not to any non-assigned claims, beginning with the 2019 MIPS payment year (83 FR 35974). We do not expect this proposal would be likely to affect a clinician’s decision to participate in Medicare or to otherwise accept assignment for a particular claim, but we solicited comment on whether stakeholders and others believe clinician behavior would change as a result of this policy. We solicited comments on the above proposal. Comment: A few commenters supported the proposal to apply the adjustment to claims that are billed and paid on an assignment-related basis and not to any non-assigned claims. PO 00000 Frm 00053 Fmt 4701 Sfmt 4700 59887 Response: We thank the commenters for their support. Comment: One commenter recommended that this policy be revisited in the next year and evaluated for unintended consequences, including whether there are any adverse effects on Medicare beneficiaries who see a nonparticipating clinician who does not accept assignment for a claim. Response: We thank the commenter for the input and will take this comment into consideration in future rulemaking. After consideration of the comments, we are finalizing our proposal to apply the MIPS payment adjustment to claims that are billed and paid on an assignment-related basis, and not to any non-assigned claims, beginning with the 2019 MIPS payment year. (c) Waiver of the Requirement To Apply the MIPS Payment Adjustment Factors to Certain Payments in Models Tested Under Section 1115A of the Act (i) Overview CMS tests models under section 1115A of the Act that may include model-specific payments made only to model participants under the terms of the model and not to any other providers of services or suppliers. Some of these model-specific payments may be considered payments for covered professional services furnished by a MIPS eligible clinician, meaning that the MIPS payment adjustment factor, and, as applicable, the additional MIPS payment adjustment factor (collectively referred to as the MIPS payment adjustment factors) applied under § 414.1405(e) of our regulations would normally apply to those payments. (ii) Summary of Proposals and Comments Received Section 1115A(d)(1) of the Act authorizes the Secretary to waive requirements of Title XVIII of the Act (and certain other requirements) as may be necessary solely for the purposes of testing models under section 1115A. We stated in the proposed rule (83 FR 35974 through 35975) that we believe it is necessary to waive the requirement to apply the MIPS payment adjustment factors to a model-specific payment or payments (to the extent such a payment or payments are subject to the requirement to apply the MIPS payment adjustment factors) for purposes of testing a section 1115A model under which such model-specific payment or payments are made in a specified payment amount (for example, $160 per-beneficiary, per-month); or paid according to a methodology for calculating a model-specific payment E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59888 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations that is applied in a consistent manner to all model participants. In both cases, applying the MIPS payment adjustment factors to these model-specific payments would introduce variation in the amounts of model-specific payments paid across model participants, which could compromise the model test and the evaluation thereof. We proposed to amend § 414.1405 to add a new paragraph (f) to specify that the MIPS payment adjustment factors applied under § 414.1405(e) would not apply to certain model-specific payments as described above for the duration of a section 1115A model’s testing beginning in the 2019 MIPS payment year (83 FR 35974 through 35975). We proposed to use the authority under section 1115A(d)(1) of the Act to waive the requirement to apply the MIPS payment adjustment factors under section 1848(q)(6)(E) of the Act and § 414.1405(e) specifically for these types of payments because the waiver is necessary solely for purposes of testing models that involve such payments (83 FR 35974 through 35975). To illustrate how the proposed waiver would apply, and to provide notice regarding one model-specific payment to which this proposed waiver would apply, we included an example in the proposed rule involving the Monthly Enhanced Oncology Services (MEOS) payment in the Oncology Care Model (OCM) (83 FR 35975). We solicited comment on this proposal. The following is a summary of the public comments received in response to our request for comment and our responses: Comment: A few commenters supported our proposal to waive the application of the MIPS payment adjustment factors to certain modelspecific payments. The commenters agreed that these waivers are necessary to test models that would involve these types of model-specific payments, and without such waivers the evaluation of certain models could be compromised. Response: We appreciate the commenters’ support. Comment: One commenter noted that the proposed amendment at § 414.1405(f) is ambiguous as to whether paragraphs (l), (2), and (3) refer to three different classes of payments, or to one class of payments that meet all three conditions. The commenter suggested that we clarify our intended policy. Response: We clarify that only payments meeting all three conditions set forth at § 414.1405(f) will qualify for the waiver of the MIPS payment adjustment factors under section 1848(q)(6)(E) of the Act and VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 § 414.1405(e). We have amended § 414.1405(f) to specify that payments must meet all three conditions to reduce any potential ambiguity, and made further amendments to § 414.1405(f) for greater clarity and readability and to more closely align with the policy described in the preamble text of the proposed rule, including to clarify that the regulatory text in § 414.1405(f)(3) refers to payments made in a consistent manner to all model participants, including those participants subject to the MIPS payment adjustment factors and participants not subject to the MIPS payment adjustment factors. After considering public comments, we are finalizing our proposal to use the authority under section 1115A(d)(1) of the Act to waive the requirement to apply the MIPS payment adjustment factors under section 1848(q)(6)(E) of the Act and § 414.1405(e) specifically for payments specified at § 414.1405(f) with the clarifying amendments described herein. As discussed in the CY 2019 PFS proposed rule (83 FR 35975), one model-specific payment to which this finalized waiver will apply is the Monthly Enhanced Oncology Services (MEOS) payment in the Oncology Care Model (OCM). The duration of this waiver will begin with the 2019 MIPS payment year and continue for the duration of OCM. We proposed to provide the public with notice that this proposed new regulation applies to model-specific payments that the Innovation Center elects to test in the future in two ways: first, we would update the Quality Payment Program website (www.qpp.cms.gov) when new modelspecific payments subject to this proposed waiver are announced; and second, we would provide a notice in the Federal Register to update the public on any new model-specific payments to which this waiver would apply (83 FR 35974 through 35975). We solicited comment on this proposal. The following is a summary of the public comments received in response to our request for comment and our responses: Comment: One commenter urged CMS to denote which models and model specific payments are subject to this new policy on the Quality Payment Program website and Federal Register as soon as possible. Response: We plan to provide the public with notice as soon as practicable for model-specific payments subject to this waiver via the Quality Payment Program website (www.qpp.cms.gov), and separate notice in the Federal Register. PO 00000 Frm 00054 Fmt 4701 Sfmt 4700 After considering public comments, we are finalizing our policy as proposed to provide the public with notice in the following two ways: (1) We will update the Quality Payment Program website (www.qpp.cms.gov) when new modelspecific payments subject to this waiver are announced; and (2) we will provide a notice in the Federal Register to update the public on any new modelspecific payments to which this waiver will apply. (d) CY 2018 Exclusion of MIPS Eligible Clinicians Participating in the Medicare Advantage Qualifying Payment Arrangement Incentive (MAQI) Demonstration (i) Overview In conjunction with releasing the CY 2019 PFS proposed rule, CMS announced the Medicare Advantage Qualifying Payment Arrangement Incentive (MAQI) Demonstration, established by CMS using our demonstration authority under section 402 of the Social Security Amendments of 1967 (as amended). The MAQI Demonstration is designed to test whether excluding MIPS eligible clinicians who participate to a sufficient degree in certain payment arrangements with Medicare Advantage Organizations (MAOs) from the MIPS reporting requirements and payment adjustments will increase or maintain participation in payment arrangements similar to Advanced APMs with MAOs and change the manner in which clinicians deliver care. (ii) Summary of Proposals We proposed to use the authority in section 402(b) of the Social Security Amendments of 1967 (as amended) to waive requirements of section 1848(q)(6)(E) of the Act and the regulations implementing it in order to waive the payment consequences (positive, negative or neutral adjustments) of the MIPS and to waive the associated MIPS reporting requirements in 42 CFR part 414 adopted to implement the payment consequences, subject to conditions outlined in the Demonstration. We noted, relating to our proposal to waive payment consequences, that the Demonstration would have the effect of removing MIPS eligible clinicians from the population across which positive and negative payment adjustments are calculated under MIPS, and because of the requirement to ensure budget neutrality with regard to the MIPS payment adjustments under section 1848(q)(6)(F)(ii) of the Act, the Demonstration may affect the payment E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations amozie on DSK3GDR082PROD with RULES3 adjustments for other MIPS eligible clinicians. We proposed that these waivers would be applicable for a MIPS eligible clinician participating in the Demonstration if they meet combined thresholds for Medicare payments or patients through Qualifying Payment Arrangements with MAOs and Advanced APMs, and that these thresholds would match the thresholds for participation in Advanced APMs under the Medicare Option of the Quality Payment Program. We also proposed to calculate thresholds based on aggregate participation in Advanced APMs and Qualifying Payment Arrangements with MAOs, without applying a specific minimum threshold to participation in either type of payment arrangement. For purposes of the Demonstration, we proposed to make determinations about clinicians’ Qualifying Payment Arrangements with MAOs, consistent with the criteria used for Other Payer Advanced APMs under the Quality Payment Program and as set forth in § 414.1420. We proposed to begin the MAQI Demonstration in CY 2018, with the 2018 Performance Period, and operate the project for a total of 5 years. We also noted in the proposed rule that, for eligible clinicians who are excluded from the MIPS reporting requirements and payment adjustment under the MAQI Demonstration, we would waive the provision in section 1848(q)(1)(A)(iii) of the Act requiring that the Secretary shall permit any eligible clinician to voluntarily report on applicable measures and activities. We clarify that, with this waiver, the Demonstration will prohibit voluntary reporting under the MIPS by eligible clinicians who participate in the Demonstration and are not subject to the MIPS reporting requirements and payment adjustment for a given year. This last waiver is intended to prevent potential gaming in the form of an eligible clinician intentionally submitting data showing poor performance for a year for which they are not subject to the MIPS reporting requirements and payment adjustment pursuant to the terms of the Demonstration in order to show improvement in their performance in future years when that improvement could result in higher MIPS scoring. (iii) Applicable Waivers Section 402(b) of the Social Security Amendments of 1967 (as amended) authorizes the Secretary to waive requirements of Title XVIII that relate to payment and reimbursement in order to carry out demonstrations under section VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 402(a). We proposed to use this authority to waive certain requirements of section 1848(q) of the Act and the regulations implementing it, specifically the payment consequences (positive, negative or neutral adjustments) of the MIPS and the associated MIPS reporting requirements in 42 CFR part 414 (adopted to implement the payment consequences), subject to conditions outlined in the Demonstration. We solicited comment on these proposals. The following is a summary of the public comments, relating to proposed waivers, received in response to our request for comment and our responses: Comment: Many commenters supported the proposal to use demonstration waiver authority (under section 402 of the Social Security Amendments of 1967 (as amended)) to test the MAQI Demonstration. Response: We appreciate the commenters’ support of the MAQI Demonstration. Comment: Many commenters urged CMS to use its waiver authority in the MAQI Demonstration to allow another path towards QP status and provide eligible clinicians with the 5 percent incentive payment offered to QPs. Response: Demonstration projects under the authority of section 402(a)(1)(A) of the Social Security Amendments of 1967 are intended to test whether changes in payment or reimbursement will increase the efficiency or economy of health care services. Our actuarial analyses determined that a demonstration design that would grant QP status, including a 5 percent incentive payment, to eligible clinicians who met the thresholds would have introduced a significant level of new costs to CMS, without adequate evidence for realizing an equal amount of savings from the proposed interventions. Without a basis to believe that the economy or efficiency of health care services would be increased, we do not believe that it is appropriate to design a demonstration with such parameters. Considering that the proposed exclusions from MIPS reporting and payment consequences under the MAQI Demonstration are not anticipated to have a net cost to CMS, we plan to test whether these exclusions will increase or maintain clinician participation in payment arrangements with MAOs that are similar to Advanced APMs and change the manner in which clinicians deliver care. This test is consistent with the standards set forth in section 402(a)(1)(A) of the Social Security Amendments of 1967. Comment: Some commenters urged CMS to monitor the impact of the PO 00000 Frm 00055 Fmt 4701 Sfmt 4700 59889 Demonstration on MIPS payment adjustments, including one commenter that expressed concern that the MIPSeligible population pool would be reduced and another commenter that expressed concern about whether the potential benefits being tested under the MAQI Demonstration outweigh any potential impacts on the level of MIPS payment adjustments. Response: We agree that it will be important to monitor the impact of the Demonstration on payments received by MIPS eligible clinicians to whom the waivers do not apply, but we note that it may be challenging to draw significant conclusions from such monitoring as there are many variables that may impact and influence a clinician’s final MIPS payment adjustment. We plan to share information on participation levels in the MAQI Demonstration with the public as soon as this information is available. Comment: A few commenters commended CMS on starting the MAQI Demonstration in 2018, while a few commenters advised CMS to clarify the timeline associated with a CY 2018 implementation of the Demonstration and when determinations would be made under the Demonstration to identify participating eligible clinicians who are excluded from the MIPS reporting requirements and payment adjustments. Response: We appreciate certain commenters’ support for beginning the Demonstration in CY 2018, and note that by doing so, clinicians that meet threshold levels of participation in Qualifying Payment Arrangements with MAOs in 2018 can be considered for exclusion from the MIPS reporting requirements and payment adjustment under the Demonstration a year before participation in such Qualifying Payment Arrangements could be considered under the All-Payer Combination Option. We anticipate collecting Qualifying Payment Arrangement and threshold information for eligible clinicians participating in the Demonstration starting in late fall of 2018, and making final CMS determinations on whether eligible clinicians meet the criteria to be excluded from the MIPS reporting requirements and payment adjustment, based on this submitted information, by December 2018 or (January 2019 at the latest). We note that eligible clinicians participating in the MAQI Demonstration in 2018 will be evaluated to determine whether they meet the criteria to be excluded from MIPS reporting requirements for the 2018 MIPS performance year, and from the E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59890 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations MIPS payment adjustment for the corresponding 2020 MIPS payment year. Comment: Some commenters recommended that CMS make changes to the Demonstration criteria relating to clinician eligibility for the exclusion from the MIPS reporting requirements and payment adjustment, such as Qualifying Payment Arrangements and thresholds. Response: As noted in the proposed rule, we intend to use criteria and requirements that are consistent with the Medicare and Other Payer Advanced APM Options under the Quality Payment Program. Changing the clinician eligibility for exclusion from the MIPS reporting requirements and payment adjustment would not be consistent with this intent. We also received comments on other provisions associated with the Demonstration. Comment: Some commenters advised CMS to make changes to the Demonstration application and data collection process. Response: The application and data collection process are outside the scope of the proposals in the CY 2019 PFS proposed rule; however, we will seek to balance reporting burden with the need to solicit information necessary to ensure that the demonstration is being implemented, tested and evaluated appropriately. Comment: A few commenters requested additional agency focus in helping physicians and practices better understand their options under Medicare, Medicare Advantage, the Quality Payment Program, the MAQI Demonstration and other value-based payment arrangements. Response: We are committed to reaching our stakeholders, including clinicians, the technology community, private payers, and beneficiaries, to raise awareness that Medicare is evolving quickly to a value-based system. In addition to raising awareness that change is occurring, we will continue current efforts to engage in a learning process with stakeholders where they may voice opinions and suggestions to help collaboratively drive the goals of the Quality Payment Program. We will continue to set expectations that this will be an iterative process, and, while change will not happen overnight, we are committed to continuing our work to improve how Medicare pays for quality and value, instead of the quantity of services. We will continue to reach out to the clinician community and others to partner in the development of ongoing education, support, and technical assistance materials and activities to VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 help clinicians understand program and model requirements, how to use available tools to enhance their practices, improve quality, reduce expenditures, and progress to participation in Advanced APMs if that is the best choice for their practice. We are offering support in the form of fact sheets, webinars, online courses, and direct technical assistance to help clinicians successfully participate in the Quality Payment Program, the MIPS or the Advanced APM track. This range of support to help clinician practices actively participate in the Quality Payment Program that can be found at the following website at https:// qpp.cms.gov/. We also discussed that the Demonstration would waive the provision in section 1848(q)(1)(A)(iii) of the Act that the Secretary shall permit any eligible clinician to voluntarily report on applicable measures and activities, so that the Demonstration would prohibit reporting under the MIPS by eligible clinicians who participate in the Demonstration and meet the thresholds to be excluded from the MIPS reporting requirements and payment adjustment for a given year. We did not receive any comments on this proposal. We explained that this waiver is necessary to prevent the potential gaming opportunity wherein participating clinicians could intentionally report artificially poor performance under the MIPS for years in which they receive waivers from MIPS payment consequences, then receive artificially inflated quality improvement points under MIPS in later years when they do not receive waivers from MIPS payment consequences. We note here that by prohibiting reporting under MIPS we are also, in effect, disallowing MIPS performance feedback for those clinicians who participate in the Demonstration and meet the criteria to be excluded from the MIPS reporting requirements and payment adjustments. Eligible clinicians who participate in the Demonstration but are not excluded from the MIPS reporting requirements and payment adjustment (whether through participation in the Demonstration or otherwise) would continue to be MIPS eligible clinicians who are subject to the MIPS reporting requirements and payment adjustment as usual. (iv) Summary of Finalized Policies After considering public comments, we are finalizing our proposals to implement the MAQI Demonstration in CY 2018 and use the authority in section 402(b) of the Social Security Amendments of 1967 (as amended) to PO 00000 Frm 00056 Fmt 4701 Sfmt 4700 waive certain requirements of section 1848(q)(6)(E) of the Act, specifically the payment consequences (positive, negative or neutral adjustments) of the MIPS and the associated MIPS reporting requirements in 42 CFR part 414 adopted to implement the payment consequences, subject to conditions outlined in the Demonstration. We are also finalizing that we will waive the provision in section 1848(q)(1)(A)(iii) of the Act that the Secretary shall permit any eligible clinician to voluntarily report on applicable measures and activities, so that the Demonstration will prohibit reporting under the MIPS by eligible clinicians who participate in the Demonstration and meet the thresholds that will trigger application of the waivers from the MIPS reporting requirements and payment adjustment for a given year. Related to this waiver of the last sentence of section 1848(q)(1)(A)(iii) of the Act, MAQI Participants who are not subject to the MIPS reporting requirements and payment adjustments will therefore not receive MIPS performance feedback under section 1848(q)(12) of the Act. In addition, we are also announcing our final policies that, under the waivers identified previously: (1) Eligibility for exclusion from the MIPS reporting requirements and payment adjustment under the MAQI Demonstration will be determined using thresholds of combined participation in Qualifying Payment Arrangements and Advanced APMs that are the same as the QP thresholds under the Medicare Option of the Quality Payment Program codified at § 414.1430(a); and (2) Qualifying Payment Arrangements under the MAQI Demonstration will be identified using criteria consistent with those used to identify Other Payer Advanced APMs codified at § 414.1420. To qualify for exclusion from the MIPS reporting requirements and payment adjustment under the MAQI Demonstration, a MAQI participating clinician must meet combined thresholds for Medicare payments or patients through Qualifying Payment Arrangements with MAOs and Advanced APMs, using Demonstration thresholds that match the thresholds for participation in Advanced APMs under the Medicare Option of the Quality Payment Program, and based on aggregate participation in Advanced APMs and Qualifying Payment Arrangements with MAOs, without applying a specific minimum threshold to participation in either type of payment arrangement. E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations (e) Example of Adjustment Factors amozie on DSK3GDR082PROD with RULES3 In the CY 2019 PFS proposed rule (83 FR 35978 through 35981), we provided a figure and several tables as illustrative examples of how various final scores would be converted to a MIPS payment adjustment factor, and potentially an additional MIPS payment adjustment factor, using the statutory formula and based on our proposed policies for the 2021 MIPS payment year. We updated the figure and tables based on the policies we are adopting in this final rule, as follows. Figure 3 provides an example of how various final scores would be converted to a MIPS payment adjustment factor, and potentially an additional MIPS payment adjustment factor, using the statutory formula and based on the policies adopted in this final rule for the 2021 MIPS payment year. In Figure 3, the performance threshold is 30 points. The applicable percentage is 7 percent for the 2021 MIPS payment year. The MIPS payment adjustment factor is determined on a linear sliding scale from zero to 100, with zero being the lowest possible score which receives the negative applicable percentage (negative 7 percent for the 2021 MIPS payment year) and resulting in the lowest payment adjustment, and 100 being the highest possible score which receives the highest positive applicable percentage and resulting in the highest payment adjustment. However, there are two modifications to this linear sliding scale. First, there is an exception for a final score between zero and one-fourth VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 of the performance threshold (zero and 7.5 points based on the performance threshold of 30 points for the 2021 MIPS payment year). All MIPS eligible clinicians with a final score in this range would receive the lowest negative applicable percentage (negative 7 percent for the 2021 MIPS payment year). Second, the linear sliding scale line for the positive MIPS payment adjustment factor is adjusted by the scaling factor, which cannot be higher than 3.0. If the scaling factor is greater than zero and less than or equal to 1.0, then the MIPS payment adjustment factor for a final score of 100 would be less than or equal to 7 percent. If the scaling factor is above 1.0, but less than or equal to 3.0, then the MIPS payment adjustment factor for a final score of 100 would be higher than 7 percent. Only those MIPS eligible clinicians with a final score equal to 30 points (which is the performance threshold in this example) would receive a neutral MIPS payment adjustment. Because the performance threshold is 30 points, we anticipate that more clinicians will receive a positive adjustment than a negative adjustment and that the scaling factor would be less than 1 and the MIPS payment adjustment factor for each MIPS eligible clinician with a final score of 100 points would be less than 7 percent. Figure 3 illustrates an example of the slope of the line for the linear adjustments and has been updated from prior rules, but it could change PO 00000 Frm 00057 Fmt 4701 Sfmt 4700 59891 considerably as new information becomes available. In this example, the scaling factor for the MIPS payment adjustment factor is 0.159. In this example, MIPS eligible clinicians with a final score equal to 100 would have a MIPS payment adjustment factor of 1.11 percent (7 percent × 0.159). (Note that this is prior to adding the additional payment adjustment for exceptional performance, which is explained below.) The additional performance threshold is 75 points. An additional MIPS payment adjustment factor of 0.5 percent starts at the additional performance threshold and increases on a linear sliding scale up to 10 percent. This linear sliding scale line is also multiplied by a scaling factor that is greater than zero and less than or equal to 1.0. The scaling factor will be determined so that the estimated aggregate increase in payments associated with the application of the additional MIPS payment adjustment factors is equal to $500,000,000. In Figure 3, the example scaling factor for the additional MIPS payment adjustment factor is 0.358. Therefore, MIPS eligible clinicians with a final score of 100 would have an additional MIPS payment adjustment factor of 3.58 percent (10 percent × 0.358). The total adjustment for a MIPS eligible clinician with a final score equal to 100 would be 1 + 0.0111 + 0.0358 = 1.0469, for a total positive MIPS payment adjustment of 4.69 percent. BILLING CODE 4120–01–P E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations amozie on DSK3GDR082PROD with RULES3 The final MIPS payment adjustments will be determined by the distribution of final scores across MIPS eligible clinicians and the performance threshold. More MIPS eligible clinicians above the performance threshold means the scaling factors would decrease because more MIPS eligible clinicians receive a positive MIPS payment adjustment factor. More MIPS eligible VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 clinicians below the performance threshold means the scaling factors would increase because more MIPS eligible clinicians would receive a negative MIPS payment adjustment factor and relatively fewer MIPS eligible clinicians would receive a positive MIPS payment adjustment factor. Table 56 illustrates the changes in payment adjustments based on the final PO 00000 Frm 00058 Fmt 4701 Sfmt 4700 policies from the 2019 MIPS payment year and the 2020 MIPS payment year, and on final policies for the 2021 MIPS payment year adopted in this final rule, as well as the statutorily required increase in the applicable percent as required by section 1848(q)(6)(B) of the Act. E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.071</GPH> 59892 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 59893 TABLE 56: Illustration of Point System and Associated Adjustments Comparison Between the 2019 MIPS payment year, the 2020 MIPS payment year and 2021 MIPS payment year amozie on DSK3GDR082PROD with RULES3 70.0100 Positive MIPS payment adjustment greater than 0% on a linear sliding scale. The linear sliding scale ranges from 0 to 4% for scores from 3.00 to 100.00. This sliding scale is multiplied by a scaling factor greater than zero but not exceeding 3.0 to preserve budget neutrality. PLUS An additional MIPS payment adjustment for exceptional performance. The additional MIPS payment adjustment starts at 0.5% and increases on a linear sliding scale. The linear sliding scale ranges from 0.5 to 10% for scores from 70.00 to 100.00. This sliding scale is multiplied by a scaling factor not greater than 1.0 in order to proportionately distribute the available funds for BILLING CODE 4120–01–C We note that in this final rule, with the exception of the increase in our small practice bonus in the quality performance category from 3 measure bonus points to 6 measure bonus points, VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 Positive MIPS payment adjustment greater than 0% on a linear sliding scale. The linear sliding scale ranges from 0 to 5% for scores from 15.00 to 100.00. This sliding scale is multiplied by a scaling factor greater than zero but not exceeding 3.0 to 70.0100 Positive MIPS payment adjustment greater than 0% on a linear sliding scale. The linear sliding scale ranges from 0 to 5% for scores from 15.00 to 100.00. This sliding scale is multiplied by a scaling factor greater than zero but not exceeding 3.0 to preserve budget neutrality. PLUS An additional MIPS payment adjustment for exceptional performance. The additional MIPS payment adjustment starts at 0.5% and increases on a linear sliding scale. The linear sliding scale ranges from 0.5 to 10% for scores from 70.00 to 100.00. This sliding scale is multiplied by a scaling factor not greater than 1.0 in order to proportionately distribute the available funds for our scoring algorithms have not changed from the CY 2019 PFS proposed rule and that the only policy change from the CY 2019 PFS proposed rule reflected in Figure 3 and Table 56 is that final scores greater than or equal to 75 points qualify PO 00000 Frm 00059 Fmt 4701 Sfmt 4700 Positive MIPS payment adjustment greater than 0% on a linear sliding scale. The linear sliding scale ranges from 0 to 7% for scores from 30.00 to 100.00. This sliding scale is multiplied by a scaling factor greater than zero but not exceeding 3.0 to 75.0100 Positive MIPS payment adjustment greater than 0% on a linear sliding scale. The linear sliding scale ranges from 0 to 7% for scores from 30.00 to 100.00. This sliding scale is multiplied by a scaling factor greater than zero but not exceeding 3.0 to preserve budget neutrality. PLUS An additional MIPS payment adjustment for exceptional performance. The additional MIPS payment adjustment starts at 0.5% and increases on a linear sliding scale. The linear sliding scale ranges from 0.5 to 10% for scores from 75.00 to 100.00. This sliding scale is multiplied by a scaling factor not greater than 1.0 in order to proportionately distribute the available funds for for the additional payment adjustment for exceptional performance discussed at section III.I.3.j.(3) of this final rule. Please refer to the CY 2019 PFS proposed rule (83 FR 35979 through 35981) for examples of scenarios in E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.072</GPH> Positive MIPS payment adjustment greater than 0% on a linear sliding scale. The linear sliding scale ranges from 0 to 4% for scores from 3.00 to 100.00. This sliding scale is multiplied by a scaling factor greater than zero but not exceeding 3.0 to 59894 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations which MIPS eligible clinicians can achieve a final score at or above the performance threshold of 30 points for the 2021 MIPS payment year. amozie on DSK3GDR082PROD with RULES3 k. Third Party Intermediaries We refer readers to § 414.1400, the CY 2017 Quality Payment Program final rule (81 FR 77362 through 77390) and the CY 2018 Quality Payment Program final rule (82 FR 53806 through 53819) for our previously established policies regarding third party intermediaries. In the CY 2019 PFS proposed rule (83 FR 35981 through 35986), we proposed to: (1) Define third party intermediary and require third party intermediaries to be based in the U.S.; (2) update certification requirements for data submission; (3) update the definition of Qualified Clinical Data Registry (QCDR); revise the self-nomination period for QCDRs; update of information required for QCDRs at the time of selfnomination; update consideration criteria for approval of QCDR measures; define the topped out timeline for QCDR measures; (4) revise the self-nomination period for qualified registries; (5) define health IT vendor; (6) update the definition, criteria, and requirements for CMS-approved survey vendor; auditing criteria; and (7) revise probation and disqualification criteria. We finalize these proposals in the manner discussed herein. (1) Third Party Intermediaries Definition In the CY 2019 PFS proposed rule (83 FR 35981), at § 414.1305, we proposed a new definition to define a third party intermediary as an entity that has been approved under § 414.1400 to submit data on behalf of a MIPS eligible clinician, group, or virtual group for one or more of the quality, improvement activities, and Promoting Interoperability performance categories. A QCDR, qualified registry, health IT vendor, or CMS-approved survey vendor are considered third party intermediaries. We also proposed to change the section heading at § 414.1400 from ‘‘Third party data submissions’’ to ‘‘Third party intermediaries’’ to elucidate the definition and function of a third party intermediary (83 FR 35981). As discussed in the CY 2019 PFS proposed rule (83 FR 35981), CMS IT systems are required to adhere to multiple agency and federal security standards and policy. CMS policy prohibits non-U.S. citizens from accessing CMS IT systems, and also requires all CMS program data to be retained in accordance with U.S. Federal policy, specifically National Institute of Standards and Technology VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 (NIST) Special Publication (SP) 800–63, which outlines enrollment and identity proofing requirements (levels of assurance) for federal IT system access. Access to the Quality Payment Program would necessitate passing a remote or in-person Federated Identity Proofing process (that is, Equifax or equivalent). A non-U.S. based third party intermediary’s potential lack of a SSN, TIN, U.S. based address, and other elements required for identity proofing and identity verification would impact their ability to pass the necessary background checks. An inability to pass identity proofing may limit or fully deny access to the Quality Payment Program if the intent is to interact with the Quality Payment Program outside of the U.S. for the purposes of reporting and storing data. These requirements are existing federal policies applicable to all HHS/ CMS FISMA systems and assets, and the requirements are not specific to the Quality Payment Program. More information on these policies is available at the following websites: HHS Information Security and Privacy Policy (IS2P) (https://www.hhs.gov/about/ agencies/asa/ocio/cybersecurity/ index.html); CMS Information Systems Security and Privacy Policy (IS2P2) (https://www.cms.gov/ResearchStatistics-Data-and-Systems/CMSInformation-Technology/ InformationSecurity/Info-SecurityLibrary-Items/CMS-InformationSystems-Security-and-Privacy-PolicyIS2P2.html); OMB Memorandum 04–04, E-Authentication Guidance for Federal Agencies (https://georgewbushwhitehouse.archives.gov/omb/ memoranda/fy04/m04-04.pdf); and NIST SP 800–63 Digital Identity Guidelines (https://pages.nist.gov/80063-3/). Therefore, in the CY 2019 PFS proposed rule (83 FR 35982) we proposed to amend § 414.1400(a)(4) to indicate that a third party intermediary’s principle place of business and retention of associated CMS data must be within the U.S. We would like to note, third party intermediaries that are authorized by us to submit data on behalf of MIPS eligible clinicians, groups, or virtual groups have not otherwise been evaluated for the capabilities, quality, or any other features or its products. The United States Government and CMS do not endorse or recommend any third party intermediary or its products. Prior to selecting or using any third party intermediary or its products, MIPS eligible clinicians, groups or virtual groups should perform their own due diligence on the entity and its products, PO 00000 Frm 00060 Fmt 4701 Sfmt 4700 including contacting the entity directly to learn more about its products. The following is a summary of the public comments received on the ‘‘Third Party Intermediaries Definition’’ proposals and our responses: Comment: One commenter appeared to advocate that clinicians who must comply with MACRA should be prohibited from using online and/or software-based third party intermediaries that do not use attorneys to advise clinicians on the law. The commenter stated that, in order to protect clinicians from failure to comply with MACRA and to achieve higher MACRA compliance rates, CMS should restrict MIPS participants from using online or software-based third party intermediaries entirely unless the use is through an EMR/EHR dashboard. In addition, the commenter stated that CMS should only allow clinicians to achieve compliance themselves or to achieve compliance through the use of an attorney or an EMR/EHR dashboard. Response: We do not believe it is appropriate to require third party intermediaries to furnish legal advice to clinicians. If a clinician wishes to receive legal advice regarding compliance with MACRA, or any other law or regulation, the clinician may hire his or her own legal counsel. To the extent the commenter is advocating to eliminate a clinician’s ability to report MIPS data through a third party intermediary, the comment is outside the scope of the rulemaking. Comment: One commenter provided a comment related to the proposed opt-in policy. The commenter encouraged us to allow third-party intermediaries, such as qualified registries, to opt-in on behalf of clinicians and groups as a function of the services they provide and that the clinician opt-in should be at the TIN/NPI level. Response: The opt-in policy is discussed in section III.I.3.c.(5) in this final rule, where we finalized that a clinician who is eligible to opt-in would be required to make an affirmative election to opt-in to participate in MIPS, elect to be a voluntary reporter, or by not submitting any data the clinician is choosing to not report. We believe that an election to opt-in to MIPS must be made by the clinician or group through a definitive opt-in decision to participate in MIPS regardless of the way in which the data is submitted. We agree that after this decision is confirmed by the clinician or group it should be deliverable through a third party intermediary, if a clinician or group is utilizing a third party intermediary for their data submission. As a result, the third party intermediary E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations amozie on DSK3GDR082PROD with RULES3 should be able to transmit the clinician’s opt-in decision to CMS. Therefore, we are amending § 414.1400(a)(4)(iv) that if the clinician chooses to opt-in in accordance with § 414.1310, the third party intermediary must be able to transmit that decision to CMS. We refer readers to section III.I.3.c.(5) of this final rule for more information regarding low volume threshold exclusion. After consideration of the public comments received, we are finalizing our proposal, as proposed, at § 414.1305, to define a third party intermediary as an entity that has been approved under § 414.1400 to submit data on behalf of a MIPS eligible clinician, group, or virtual group for one or more of the quality, improvement activities, and Promoting Interoperability performance categories. A QCDR, qualified registry, health IT vendor, or CMS-approved survey vendor are considered third party intermediaries. We are also finalizing our proposal, as proposed, to change the section heading at § 414.1400 from ‘‘Third party data submissions’’ to ‘‘Third party intermediaries’’ to elucidate the definition and function of a third party intermediary. In addition, we are finalizing our proposal, as proposed, to amend previously finalized policies at § 414.1400(a)(4) to indicate that a third party intermediary’s principle place of business and retention of associated CMS data must be within the U.S. Lastly, we are amending § 414.1400(a)(4)(iv) to state that if the clinician chooses to opt-in in accordance with § 414.1310, the third party intermediary must be able to transmit that decision to CMS. (2) Certification We previously finalized in the CY 2018 Quality Payment Program final rule (82 FR 53807) at § 414.1400(a)(5), that all data submitted to us by a third party intermediary on behalf of a MIPS eligible clinician, group or virtual group must be certified by the third party intermediary to the best of its knowledge as true, accurate, and complete; and that this certification must occur at the time of the submission and accompany the submission. We have discovered it is not operationally feasible to require certification at the time of submission, or to require that the certification accompany the submission, for submission types by third party intermediaries, including data via direct, login and upload, login and attest, CMS Web Interface or Medicare Part B claims. We refer readers to section III.I.3.h.(1)(b) of this final rule for our proposed modifications to the VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 previously established data submission terminology. In order to address these various submission types that are currently available, in the CY 2019 PFS proposed rule (83 FR 35982), we proposed to amend § 414.1400(a)(5) to state that all data submitted to CMS by a third party intermediary must be certified as true, accurate, and complete to the best of its knowledge and that such certification must be made in a form and manner and at such time as specified by CMS. We did not receive any public comments on our proposed amendments to the certification requirement imposed on third party intermediaries. We are finalizing our proposal, as proposed, at § 414.1400(a)(5) to state that all data submitted to CMS by a third party intermediary on behalf of a MIPS eligible clinician, group or virtual group must be certified by the third party intermediary as true, accurate, and complete to the best of its knowledge, and that such certification must be made in a form and manner and at such time as specified by CMS. (3) Qualified Clinical Data Registries (QCDRs) We refer readers to the CY 2018 Quality Payment Program final rule (82 FR 53807 through 53815) and § 414.1400 for our previously finalized policies regarding QCDRs. In the CY 2019 PFS proposed rule (83 FR 35982 through 35984) we proposed to update the following: The definition of QCDR, the self-nomination period for QCDRs, information required for QCDRs at the time of self-nomination, and consideration of criteria for approval of QCDR measures. (a) Proposed Update to the Definition of a QCDR In the CY 2017 Quality Payment Program final rule (81 FR 77363 through 77364) at § 414.1305, we finalized the definition of a QCDR to be a CMSapproved entity that has self-nominated and successfully completed a qualification process to determine whether the entity may collect medical or clinical data for the purpose of patient and disease tracking to foster improvement in the quality of care provided to patients. As described in the CY 2019 PFS proposed rule (83 FR 35982), we want to ensure that QCDRs that participate in MIPS have access to clinical expertise in quality measurement and are able to provide and demonstrate an understanding of the clinical medicine, evidence-based gaps in care, and opportunities for improvement in the PO 00000 Frm 00061 Fmt 4701 Sfmt 4700 59895 quality of care delivered to patients and priorities that are important to MIPS eligible clinicians. From our experiences with QCDRs to date, we have discovered that certain entities with predominantly technical backgrounds have limited understanding of medical quality metrics or the process for developing quality measures are seeking approval as a QCDR. A large number of entities that do not have the necessary clinical expertise to foster quality improvement have self-nominated or indicated their interest in becoming QCDRs. In reviewing previous QCDR measure submissions during the self-nomination and QCDR measure review and approval cycles in MIPS, we have observed that some entities were developing QCDR measures without a complete understanding of measure constructs (such as what is required of a composite measure or what it means to risk-adjust), and in some instances, QCDRs were developing QCDR measures in clinical areas in which they did not have expertise. We are concerned that QCDR measures submitted by such entities for approval have not undergone the same consensus development, scientific rigor, and clinical assessment that is required for measure development, compared to those QCDR measures that are developed by specialty societies and other entities with clinical expertise. We recognize the importance of these organizations’ expertise within the Quality Payment Program; however, do not believe that these types of entities with the absence of clinical expertise in quality measurement, meet the intent of QCDRs. We believe that with the increasing interest in QCDRs and QCDR measure development, it is important to ensure that QCDRs that participate in MIPS are first and foremost in the business of improving the quality of care clinicians provide to their patients through quality measurement and/or disease tracking and have the clinical expertise to do so. In the CY 2019 PFS proposed rule (83 FR 35982 through 35983), we proposed beginning with the 2022 MIPS payment year, to amend § 414.1305 to modify the definition of a QCDR to state that the approved entity must have clinical expertise in medicine and quality measure development. Specifically, a QCDR would be defined as an entity with clinical expertise in medicine and in quality measurement development that collects medical or clinical data on behalf of a MIPS eligible clinician for the purpose of patient and disease tracking to foster improvement in the quality of care provided to patients. E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59896 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations As described in the CY 2019 PFS proposed rule (83 FR 35983), under § 414.1400(b)(2)(ii), an entity that uses an external organization for purposes of data collection, calculation, or transmission may meet the definition of a QCDR as long as the entity has a signed, written agreement that specifically details the relationship and responsibilities of the entity with the external organization effective as of September 1 the year prior to the year for which the entity seeks to become a QCDR. Thus, we expect entities without clinical expertise in medicine and quality measure development that want to become QCDRs would collaborate or align with entities with such expertise in accordance with § 414.1400(b)(2)(ii). As a part of the self-nomination process, we will look for entities that have quality improvement, measure development, as well as clinical expertise. We will also follow up with the entity via, for example, email or teleconference, should we question whether or not the entity meets our standards. Alternatively, such entities may seek to qualify as another type of third party intermediary, such as a qualified registry. Becoming a qualified registry does not require the level of measure development expertise that is needed to be a QCDR that develops measures. The following is a summary of the public comments received on the proposal to update the definition of a QCDR and our responses: Comment: Many commenters supported the proposal to modify the definition of a QCDR to limit approval to entities that have clinical expertise in medicine and quality measure development. Several commenters recommended CMS provide clarification on how such clinical and quality measure development expertise will be evaluated, with one commenter suggesting the definition of clinical expertise include having a majority-led physician Board of Directors or governing body and that expertise in clinical measure development include demonstrated QCDR measure development processes that take into account the CMS Blueprint for measure development and maintenance activities. A few commenters stated that CMS should establish processes for denying applications and/or measures that appear to not have had any clinical influence rather than requiring the entire entity to have ‘‘expertise’’ and provide a definition of what constitutes ‘‘clinical expertise in medicine and quality measure development.’’ Response: We appreciate the commenters’ support to update the VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 definition of a QCDR, limiting approval to entities that have clinical expertise in medicine and quality measure development. Specifically, we proposed that a QCDR would be defined as an entity with clinical expertise in medicine and in quality measurement development that collects medical or clinical data on behalf of a MIPS eligible clinician for the purpose of patient and disease tracking to foster improvement in the quality of care provided to patients. We appreciate the commenters’ suggestion that CMS provide more clarification on how such clinical and quality measure development expertise will be evaluated. For example, while not exhaustive, some aspects that may be considered during our evaluation are a QCDR’s: Previous measure development experience (serving on an NQF TEP, for example); experience with the measure development Blueprint process, which can be found at https:// www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/MMS/Downloads/ Blueprint-130.pdf; ability to create and use multi-strata and composite measures where appropriate; ability to risk adjust its own QCDR outcomes measures; technical expertise to run a registry; and ability to reliably collect, retain, aggregate, disseminate, and analyze data from their clinicians. We appreciate the commenter’s suggestion to include having a majority-led physician Board of Directors or governing body, but we do not mandate that the QCDR be led by a majority of physicians. We do consider clinical expertise and experience in QCDR measure development and maintenance important, as shown in our updated definition of a QCDR. Comment: One commenter expressed concern regarding how CMS will allow technical entities to partner with an external organization to gain clinical expertise, citing its opinion that doing so would render the policy ineffective if this enables technical entities to bypass this requirement too easily. Another commenter stated that neither small nor large EHR vendors should be allowed to enter the QCDR space due to the former potentially collecting skewed data related to certain practice arrangements and patient populations and the latter potentially lacking the perspective of care improvement in medical specialties. Response: We disagree that allowing technical entities to partner with an external organization to gain clinical expertise would render the policy ineffective. The policy is intended to include entities that are able to meet the definition, whether that be by a PO 00000 Frm 00062 Fmt 4701 Sfmt 4700 partnership with a clinical entity, or on their own. In addition, we disagree that neither small nor large EHR vendors should be allowed to collaborate to become a QCDR. As stated in the proposed rule, entities without clinical expertise in medicine and quality measure development, such as small or large EHR vendors, may collaborate or align with entities with such expertise in accordance with § 414.1400(b)(2)(ii). In general, we do not believe that Health IT vendors, including EHR vendors, alone have the necessary clinical expertise. Having the option to collaborate could alleviate the likelihood of skewed data or the absence of perspective regarding care improvement in medical specialties, because a collaboration with a clinical organization would provide knowledge of patient populations, practice arrangements, and care improvement. Comment: A few commenters disagreed with the proposed update to the definition of a QCDR, citing their beliefs that the updated definition is contrary to the promotion of the benefits of technology; will impose artificial barriers to entry into the market; dictate who can provide services to physicians instead of letting the free market decide; and discriminate against potential vendors because of a perceived advantage at quality measurement based on education, experience, etc. The commenters stated that CMS should only require QCDRs to collaborate with specialty societies in the development of measures to ensure validity, clinical relevance, and proper risk adjustment. Response: We disagree that the modified definition of QCDR opposes promoting the benefits of technology because there are many options through which MIPS eligible clinicians can utilize different third-party intermediaries to submit data, and this proposed change will not impact the ability for MIPS eligible clinicians to use these mechanisms. We also disagree that the modified definition of QCDR imposes barriers into the market or discriminates against potential vendors because we offer vendors with more of a technical background the opportunity to partner with an organization with greater clinical expertise in order to meet the new QCDR definition. The intent of the modified definition is to promote useful measure development and to emphasize that clinical expertise is critical in gaining useful measures. Furthermore, we believe that updating the definition of a QCDR will help organizations understand the criteria in which we evaluate them against. We want to ensure that the vendors we approve to participate as a QCDR are of E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations a higher standard and understand the clinical science based off which they develop measures. It is important that QCDRs also understand how to construct measures, the analytics, and are able to ensure the measures are reliable and valid, not doing so may negatively impact the clinician’s reporting and final score. Health IT vendors and/or EHR vendors should collaborate with clinical organizations such as specialty societies for their experience not only in measure development but for their clinical expertise as well. Comment: Some commenters stated that CMS should develop a process by which a clinician who believes they are unsupported by a QCDR can submit information to CMS for further investigation. Response: If an eligible clinician would like to bring information to CMS’ attention regarding a QCDR being unsupportive as it pertains to reporting issues, we suggest the clinician contact the Quality Payment Program Service Center by emailing: QPP@cms.hhs.gov. Comment: One commenter noted that the proposed change may preclude its continued approval by CMS as a QCDR because it does not dictate the timeline in which specialty societies perform measure development and without this approval, it would not be able to assist them in measure development when necessary. Response: Our updated definition of a QCDR would be effective beginning with the 2022 MIPS payment year; and to clarify, we will not be ‘‘grandfathering’’ in existing QCDRs who do not meet the updated QCDR definition for the 2020 performance period. In coordination with the finalization of the new QCDR definition and the publication of the CY 2019 PFS final rule, we intend to notify existing QCDRs as to whether they would meet the new QCDR definition or not based on information submitted for a previous MIPS payment year. Comment: A few commenters stated that CMS should finalize its proposal for the 2019 performance year instead of the 2020 performance year because removing non-clinician led vendors from the list of QCDRs will not pose a significant burden on eligible clinicians or group practices in 2019. Response: While we appreciate commenters’ support, we would like to keep the effective timeframe of this policy (that is, the 2020 performance year) as proposed to provide existing QCDRs that would not meet the updated QCDR definition with an appropriate amount of time to comply or take other paths. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 Comment: Many commenters who supported the proposal to update the definition of a QCDR also provided recommendations including: Development of a separate definition for QCDRs put forth by technology companies to differentiate them from QCDRs managed by specialty societies; requiring third-party entities that are not specialty societies that would like to become QCDRs to collaborate with specialty society QCDRs; and expansion of the definition of a QCDR to align with the 21st Century Cures Act (especially with regard to entities being clinicianled) or at minimum, revision of the definition to include clinical expertise in medicine, quality improvement, and quality measure/guideline development, as well as providing methods to ensure data quality, routine metric reporting, and quality improvement consultation. Response: We do not agree that separate definitions are necessary to differentiate between QCDRs, as the definition includes criteria set for all QCDRs; or that the definition requires criteria as prescriptive as entities being clinician-led. There are flexibilities in place, such as collaboration with other entities such as large healthcare systems, regional collaboratives, or specialty societies, in order for vendors to meet the criteria in the definition. We believe we cover the areas of clinical expertise, measure development, and quality improvement work through this new definition. We believe that experience with data quality and routine metric reporting is related to their measure development experience and their registry experience, which is covered by the new QCDR definition and the criteria of requiring that the vendor must exist by January 1 of the performance period and have 25 participants submitting data to the QCDR (not necessarily for purposes of MIPS). After consideration of the public comments received, we are finalizing our proposal to update the definition of a QCDR at § 414.1305 beginning with the 2022 MIPS payment year, as proposed, to state that a QCDR is an entity with clinical expertise in medicine and in quality measurement development that collects medical or clinical data on behalf of a MIPS eligible clinician for the purpose of patient and disease tracking to foster improvement in the quality of care provided to patients. (b) Establishment of an Entity Seeking To Qualify as a QCDR In the CY 2017 Quality Payment Program final rule (81 FR 77364), we require at § 414.1400(c)(2) that the PO 00000 Frm 00063 Fmt 4701 Sfmt 4700 59897 QCDR must have at least 25 participants by January 1 of the performance period. These participants do not need to use the QCDR to report MIPS data to us; rather, they need to submit data to the QCDR for quality improvement. We realize that a QCDR’s lack of preparedness to accept data from MIPS eligible clinicians and groups beginning on January 1 of the performance period may negatively impact a clinician’s ability to use a QCDR to report, monitor the quality of care they provide to their patients (and act on these results) and may inadvertently increase clinician burden. For these reasons, we proposed to redesignate § 414.1400(c)(2) as § 414.1400(b)(2)(i) to state that beginning with the 2022 MIPS Payment Year, the QCDR must have at least 25 participants by January 1 of the year prior to the performance period (83 FR 35983). These participants do not need to use the QCDR to report MIPS data to us; rather, they need to submit data to the QCDR for quality improvement. The following is a summary of the public comments received on the ‘‘Establishment of an Entity Seeking To Qualify as a QCDR’’ proposals and our responses: Comment: Many commenters disagreed with the proposal to require QCDRs to have 25 participants by January 1 of the year prior to performance period. Commenters noted it would place an undue burden on QCDRs serving small specialties and inhibit the ability of new registries to qualify as QCDRs, thus discouraging the use of QCDRs to report MIPS data. One commenter suggested CMS work with stakeholders to develop a timeline that is feasible and leads to properly functioning QCDRs that can meet the goals of the MIPS program and the requirements of the MACRA law. Another commenter stated that the existing requirement is sufficient to ensure QCDR preparedness, while another commenter stated that the threshold should be lowered or removed completely, at least for those QCDRs that have already been in operation and have lost participants when the low volume threshold increased significantly. Response: We disagree with commenters that this proposed policy would cause undue burden or the ability of new entities to qualify as QCDRs. To clarify, this requirement would demonstrate that the entity has prior registry experience and the capability to accept, aggregate, calculate, provide feedback to their participants on, retain, and submit the data to CMS on the behalf of MIPS eligible clinicians. We have previously experienced during E:\FR\FM\23NOR3.SGM 23NOR3 59898 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations the past two performance periods that there have been instances of new QCDRs that are not ready to accept data from eligible clinicians from the start of the performance period due to operational issues within the QCDR, including instances of QCDRs withdrawing during the performance period because of reporting inexperience. We proposed this requirement to ensure that organizations have this experience prior to selfnomination. We continue to provide educational materials for QCDRs on what is necessary to meet program criteria and requirements. We clarify that the requirement to have at least 25 participants by January 1 of the year prior to performance period does not require that the entity’s prior registry experience be under MIPS or any other CMS program or that the participants be MIPS eligible clinicians. With increasing stakeholder interest in the use of third-party intermediaries to report for MIPS, we believe the threshold of 25 participants is a reasonable thresholds for QCDRs to attain. After consideration of the public comments received, we are finalizing our proposal, as proposed, to redesignate § 414.1400(c)(2) as § 414.1400(b)(2)(i) to state that beginning with the 2022 MIPS Payment Year, the QCDR must have at least 25 participants by January 1 of the year prior to the applicable performance period. amozie on DSK3GDR082PROD with RULES3 (c) Self-Nomination Process We refer readers to the CY 2018 Quality Payment Program final rule (82 FR 53808 through 53813) for our previously established policies regarding the simplified self-nomination process for existing QCDRs in MIPS that are in good standing and web-based submission of self-nomination forms. We did not propose any changes to those policies in this final rule; however, in the CY 2019 PFS proposed rule (83 FR 35983), we proposed to update: (1) The self-nomination period; and (2) information required at the time of self-nomination. (i) Self-Nomination Period Under § 414.1400(b), QCDRs must self-nominate from September 1 of the year prior to the applicable performance period until November 1 of the same year and must, among other things, provide all information requested by us at the time of self-nomination. As indicated in the CY 2017 Quality Payment Program final rule (81 FR 77366), our goal has been to publish the list of approved QCDRs along with their VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 approved QCDR measures prior to the beginning of the applicable performance period. We have received feedback from entities that have self-nominated to be a QCDR about the need for additional time to respond to requests for information during the review process, particularly with respect to QCDR measures that the entity intends to submit to us for the applicable performance period. In addition, based on our observations of the previous two self-nomination cycles, we anticipate an increase in the number of QCDR measure submissions for our review and consideration. For the transition year of MIPS, we received over 1,000 QCDR measure submissions for review, and for the CY 2018 performance period, we received over 1,400 QCDR measure submissions. In order for us to process, review, and approve the QCDR measure submissions and provide QCDRs with sufficient time to respond to requests for information during the review process, while still meeting our goal to publish the list of approved QCDRs along with their approved QCDR measures prior to the start of the applicable performance period, we believe that an earlier selfnomination period is needed. Therefore, in the CY 2019 PFS proposed rule (83 FR 35983), we proposed to update the self-nomination period from September 1 of the year prior to the applicable performance period until November 1 to July 1 of the calendar year prior to the applicable performance period until September 1. Therefore, in the CY 2019 PFS proposed rule (83 FR 35983), we also proposed to amend § 414.1400(b)(1) to provide that, beginning with the 2022 MIPS payment year, entities seeking to qualify as QCDRs must self-nominate during a 60day period beginning on July 1 of the calendar year prior to the applicable performance period and ending on September 1 of the same year; must provide all information required by us at the time of self-nomination; and must provide any additional information requested by us during the review process. For example, for the 2022 MIPS payment year, the applicable performance period would be CY 2020, as discussed in section III.I.3.g. of this final rule. Therefore for the CY 2020 performance period, the self-nomination period would begin on July 1st, 2019 and end on September 1st, 2019, and we will make QCDRs aware of this through our normal communication channels. We believe that updating the selfnomination period would allow for additional review time and measure discussions with QCDRs. PO 00000 Frm 00064 Fmt 4701 Sfmt 4700 We refer readers to section III.I.3.k.(3)(c)(ii) of this final rule for a summary of the public comments received on these proposals and our responses. (ii) Information Required at the Time of Self-Nomination We refer readers to the CY 2018 Quality Payment Program final rule (82 FR 53814), where we finalized that as a part of the self-nomination review and approval process for the CY 2018 performance period and future years, we will assign QCDR measure IDs to approved QCDR measures, and the same measure ID must be used by any other QCDRs that have received permission to also report the measure. We have received some questions from stakeholders as to whether the QCDR measure ID must be utilized or whether it is optional. As stated in the CY 2018 Quality Payment Program final rule, QCDRs, including any other QCDRs that have received permission to also report the measure, must use the CMSassigned QDCR measure ID. It is important that the CMS-assigned QCDR measure ID is posted and used accordingly, because without this ID we are not able to accurately identify and calculate the QCDR measures according to their specifications. Therefore, in the CY 2019 PFS proposed rule (83 FR 35983), we proposed to update § 414.1400(b)(3)(iii) to state that QCDRs must include their CMS-assigned QCDR measure ID number when posting their approved QCDR measure specifications, and also when submitting data on the QCDR measures to us. The following is a summary of the public comments received on the ‘‘SelfNomination Process’’ proposals and our responses: Comment: Several commenters noted they would support the proposed change to the self-nomination timeline if CMS would adopt multi-year approval of QCDRs as they noted doing so would reduce burden, alleviate a shortened nomination timeline, potentially strengthen the measure development process in future years, encourage uptake of new measures, allow for uninterrupted data collection, and allow for more consistent and robust data collection and benchmarking. Response: In the CY 2018 Quality Payment Program final rule (82 FR 53808), we discussed our concerns with multi-year approval and sought comment from stakeholders as to how to mitigate our concerns. Moreover, a multi-year approval process would not take into consideration potential changes in criteria or requirements of participation for QCDRs that may occur E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations as the MIPS program develops through future program years. We did not receive any suggestions or responses from stakeholders that would alleviate our concerns with adopting this policy. Therefore, we continue to believe multiyear approval of QCDRs is inappropriate at this time. Comment: One commenter stated that in order to encourage QCDRs to continue seeking QCDR status, CMS should work with specialty-led QCDR stewards to further improve the selfnomination process and ensure a viable and private sector-run reporting option to alleviate burden and increase evidence-based decisions. Response: We value stakeholder input and conduct process improvement on an ongoing basis. We will continue to seek opportunities to receive input throughout the year. Comment: Many commenters disagreed with the proposal to change the QCDR self-nomination period, citing their beliefs that maintaining the September 1 through November 1 selfnomination period without change is necessary to minimize additional burden and constraints on QCDRs; provide QCDRs the time to prepare data to support measures in the application process; provide QCDRs an opportunity to gain insight into recent policy changes; and negate potentially adverse impacts to the life cycle of QCDRs, the maintenance process for existing QCDR measures, and/or development of new measures. One commenter stated that due to additional data being required as part of the self-nomination process, the revised self-nomination period would be more difficult. Another commenter suggested the change should not be implemented until the CY 2021 performance period and noted QCDR approval will need to expand beyond 12 months to avoid a scenario where a QCDR is only approved for a few months before they must go through the self-nomination process again. Finally, another commenter suggested the selfnomination period be extended to 90 days due to its belief that the 60-day period is excessively challenging and burdensome in terms of the information required and additional requests to which QCDRs must be respond. Response: As described in the CY 2019 PFS proposed rule (83 FR 35983), we have heard from QCDRs that they need additional time to respond to our requests for additional information during the QCDR measure review process, as well as requests for feedback or measure harmonization across QCDRs in a more extensive manner that would not be feasible with the current timeline. We believe with sufficient VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 notice, providing stakeholders with educational material, and the implementation of the simplified selfnomination process we are minimalizing additional burden on QCDRs. Through the publication of selfnomination reference material prior to the self-nomination period, as we have done for the 2019 self-nomination period, we intend on giving QCDRs the utmost resources and support as they prepare to self-nominate prior to the closing of the self-nomination period. We plan to post self-nomination material prior to the start of the selfnomination period in July, thereby giving stakeholders’ time to prepare the necessary materials needed, inclusive of the additional information requested as a part of the self-nomination process. As we develop QCDR and qualified registry related policies for future rulemaking, we will factor in how the proposals impact an entity’s ability to selfnominate and participate in the program prior to deciding what year to implement the policies for. We do not believe that delaying the finalization of this proposal until the 2021 performance period of MIPS would benefit the QCDRs, as we have previously explained, QCDR selfnomination must occur on an annual basis to take into consideration policy, participation requirement, and considerations to a QCDR or registry’s standing (if they are on probation or have been precluded). We believe the benefits of moving up the self-nomination period to allow for additional time and discussion of QCDR measures is beneficial for both QCDRs and CMS. We disagree that the selfnomination period needs to be extended to a 90-day period, we believe with the resource materials provided, as well as us offering to meet with QCDRs prior to self-nomination to discuss their QCDR measures and receive preliminary feedback, QCDRs have the ability to better prepare for the self-nomination period. Comment: A few commenters supported the proposal to update the QCDR self-nomination timeline. One commenter stated that CMS should use the updated nomination period to facilitate additional discussion with QCDRs regarding measure development. Another commenter stated that CMS should change its expectations for providing data for measures accordingly and allow a transition year to lessen the impact on the measure development life cycle and maintenance of existing measures. Response: We agree that this change in the self-nomination period will allow for additional conversations on measure PO 00000 Frm 00065 Fmt 4701 Sfmt 4700 59899 development and QCDR measure feedback. We disagree with the implementation of a transition year, considering that on annual basis we must review performance data to evaluate whether the measure demonstrates a gap in performance or whether the measure demonstrates topped out performance where no meaningful measurement can be obtained. As previously mentioned, QCDR measures do not have to go through the NQF’s Measures Application Partnership (MAP) committee prior to implementing them in MIPS. If a QCDR is unable to provide performance data reflecting a gap, the QCDR may provide for our consideration citations to recent studies or clinical journals that demonstrate a need for measurement. Comment: One commenter suggested CMS provide a definition of ‘‘minimal changes’’ regarding the QCDR selfnomination process as well as specifications around data requests to support QCDR measures. Response: In the CY 2018 Quality Payment Program final rule (82 FR 53811), we stated that minimal changes include, but are not limited to: Limited changes to performance categories, adding or removing MIPS quality measures, and adding or updating existing services and/or cost information. Additional educational resources are available in the QPP resource library at https://qpp.cms. gov/. Comment: One commenter recommended changes to the QCDR self-nomination process, including updating QCDR self-nomination application and materials to outline all of the information needed to determine QCDR status to avoid delays and misunderstandings and providing at least a 60-day notice of any changes to the QCDR vetting process, including review of measures and a minimum of 30 days to appeal changes. The commenter further stated that changes to the 2019 QCDR application requirements should not be made until after the final rule is released due to the current QCDR application timeline closing on November 1 coinciding with publication of the final rule and that since the majority of specialty QCDRs stewards are currently submitting QCDR applications, CMS should allow these QCDRs to fully comment on these new proposed standards to which they are being held and which they may not support. Alternatively, the commenter suggested CMS allow for a nimble 2019 QCDR application process, including changes to the licensing standards given E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59900 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations the significant changes CMS proposes for 2019. Response: To clarify, we proposed that the self-nomination period be moved for the 2020 performance period, not the 2019 performance period as indicated by the commenter, to allow for sufficient time and notice of the changes. We will continue to provide educational materials that will outline all of the information needed to evaluate a QCDR’s ability to meet participation standards and QCDR measure evaluation criteria prior to the start of the self-nomination period. With the publication of this final rule, we intend on communicating any changes to the review process. For the 2019 performance period, it is not feasible to allow for a minimum of 30 days to appeal changes due to our goal of approving and publicizing the QCDRs by the start of the performance period. By moving up the self-nomination period, we will be able to allow QCDRs to have more time to consider our QCDR measure feedback. Additionally, moving the timeline to earlier in the year will allow CMS to review the measures fully and provide feedback to the QCDR who submitted the measures. The earlier selfnomination will also allow QCDRs who submit clinically similar measures to another QCDR and whose measure(s) are rejected to reach out to the QCDR whose measures are approved to attempt to enter into a licensing use agreement with the QCDR with the approved measures if desired. It is the goal of CMS to post the most comprehensive list of approved QCDRs and their measures before the start of the performance period so that eligible clinicians intending to use a QCDR can review these materials and select the QCDR that best meets their needs. In this way, the eligible clinician may begin submitting data to the QCDR at the start of the performance period. By doing so, the clinician will be more likely to receive timely feedback from the QCDR regarding his/her performance (earlier in the year) which will allow for quality improvement to occur during the performance period instead of receiving this data later in the year or after the conclusion of the performance period. The CY 2019 performance period selfnomination form reflects the proposed MIPS quality measures, Promoting Interoperability measures, and Improvement Activities as proposed in the CY 2019 PFS proposed rule. We include disclaimer language that indicates that measures and activity availability are subject to change, pending upon what is finalized in the final rule. We continuously take into VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 consideration stakeholder feedback as we look into process improvements and policy development for future program years. We appreciate the commenters’ suggestions, and ask that they provide more detail as to the changes to the licensing standards that they recommend we implement for future consideration. After consideration of the public comments received, we are finalizing our proposal to amend § 414.1400(b)(1) to provide that, beginning with the 2022 MIPS payment year, entities seeking to qualify as QCDRs must self-nominate during a 60-day period beginning on July 1 of the calendar year prior to the applicable performance period and ending on September 1 of the same year; must provide all information required by us at the time of self-nomination; and must provide any additional information requested by us during the review process. In addition, we are finalizing our proposal to update § 414.1400(b)(3)(iii) to state that QCDRs must include their CMS-assigned QCDR measure ID number when posting their approved QCDR measure specifications, and also when submitting data on the QCDR measures to us. (d) QCDR Measure Requirements We refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77374 through 77375) for where we previously finalized standards and criteria used for selecting and approving QCDR measures. We finalized that QCDR measures must: Provide specifications for each measure, activity, or objective the QCDR intends to submit to CMS; and provide CMS descriptions and narrative specifications for each measure, activity, or objective no later than November 1 of the applicable performance period for which the QCDR wishes to submit quality measures or other performance category (improvement activities and Promoting Interoperability) data starting with the 2018 performance period and in future program years. In the CY 2019 PFS proposed rule (83 FR 35983), we proposed to consolidate our previously finalized standards and criteria used for selecting and approving QCDR measures at § 414.1400(e) and (f) at § 414.1400(b)(3). We also proposed to apply certain criteria used under the Call for Quality Measures Process when considering QCDR measures for possible inclusion in MIPS beginning with the MIPS 2021 payment year (83 FR 35983). In the CY 2018 Quality Payment Program final rule (82 FR 53814), we noted our interest in elevating the standards for which QCDR measures are selected and approved for use and PO 00000 Frm 00066 Fmt 4701 Sfmt 4700 sought comment on whether the standards and criteria used for selecting and approving QCDR measures should be more closely aligned with those used for the Call for Quality Measures process described in the CY 2017 Quality Payment Program final rule (81 FR 77151). Some commenters expressed concern with this alignment, stating that the Call for Measures process is cumbersome, and would increase burden. Other commenters expressed the belief that the Call for Measures process does not recognize the uniqueness of QCDRs, and is not agile. We would like to clarify that our intention with any future alignment is to work towards consistent standards and evaluation criteria that would be applicable to all MIPS quality measures, including QCDR measures. We understand that some of the criteria under the Call for Measures process may be difficult for QCDRs to meet prior to submitting a particular measure for approval; however, we believe that the criteria under the Call for Measures process helps ensure that any new measures are reliable and valid for use in the program. Having a greater alignment in measure standards helps ensure that MIPS eligible clinicians and groups are able to select from an array of measures that are considered to be higher quality and provide meaningful measurement. As such, we believe that as we gain additional experience with QCDRs in MIPS, it would be appropriate to further align these criteria for QCDR measures with those of MIPS quality measures in future program years. Therefore, in addition to the QCDR measure criteria previously finalized at § 414.1400(f), we proposed in the CY 2019 PFS proposed rule (83 FR 35984) to apply select criteria used under the Call for Measures Process, as described in the CY 2018 Quality Payment Program final rule (82 FR 53636). Specifically, in addition to the QCDR measure criteria at proposed § 414.1400(b)(3), we proposed in the CY 2019 PFS proposed rule (83 FR 35984) to apply the following criteria beginning with the 2021 MIPS payment year when considering QCDR measures for possible inclusion in MIPS: • Measures that are beyond the measure concept phase of development. • Preference given to measures that are outcome-based rather than clinical process measures. • Measures that address patient safety and adverse events. • Measures that identify appropriate use of diagnosis and therapeutics. • Measures that address the domain for care coordination. E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations • Measures that address the domain for patient and caregiver experience. • Measures that address efficiency, cost and resource use. • Measures that address significant variation in performance. We believe that as we gain additional experience with QCDRs in MIPS, it would be appropriate to further align these criteria for QCDR measures with those of MIPS quality measures in future program years. Specifically, we are considering proposing to require reliability and feasibility testing as an added criteria in order for a QCDR measure to be considered for MIPS in future rulemaking. In addition, we refer readers to the CMS Quality Measure Development Plan at https://www.cms.gov/Medicare/ Quality-Initiatives-Patient-AssessmentInstruments/Value-Based-Programs/ MACRA-MIPS-and-APMs/FinalMDP.pdf for more information regarding the measure development process. The following is a summary of the public comments received on the ‘‘QCDR Measure Requirements’’ proposals and our responses: Comment: A few commenters stated that CMS should offer multi-year approval of QCDR measures to maximize stability and predictability while minimizing redundancy. The commenters further stated that QCDRs should be allowed to make minor modifications to measures under this multi-year approval process based on updated guidelines, evidence, or measure methodologies and if QCDR measures were approved for 2 to 3 years, the earlier self-nomination deadline would not be as problematic for registry vendors and would streamline CMS’ process. Response: We disagree that offering multi-year approval of QCDR measures would minimize redundancy, as this may actually lead to duplicative measures which is counter intuitive to our meaningful measures initiative. Multi-year approvals of QCDR measures does not account for the possibility of there being more robust QCDR measures of similar concepts being submitted for CMS consideration. We may consider a similar process for future years, which is used with MIPS quality measures, where we’d continue to evaluate all the measures on an annual basis and compare them to those submitted during the measure consideration period (selfnomination period) to determine what QCDR measures would be best to include for the upcoming performance period. QCDRs making changes to their measures would have to self-nominate those changes for CMS’ approval, and if we receive measures of similar concept VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 that are more robust they may be considered to replace the existing approved QCDR measures. Comment: One commenter supported the proposal to include the CMSassigned QCDR measure ID number when posting the approved QCDR measure specifications, and also when submitting data on the QCDR measures to CMS. Response: We appreciate the commenter’s support. Comment: One commenter stated that CMS should not approve highly duplicative measure concepts submitted at a later time as doing so increases confusion among physicians and competition among QCDRs while disregarding the time, resources, and intellectual property rights of the measure owners. Some commenters noted that measures are misaligned, overlapping and duplicative across QCDR and MIPS measures. Response: We agree that duplicative measures are counterintuitive to the Meaningful Measures initiative that promotes more focused quality measure development towards outcomes that are meaningful to patients, families and their providers. It is our intent to move toward measure harmonization, which supports our efforts to increase measure alignment and eliminate redundancy both within the MIPS measure set and across CMS programs. Comment: A few commenters supported the proposal to update QCDR measure criteria and encouraged CMS to have dialogue with QCDRs regarding the submission of measures. One commenter stated that CMS should expand the policy toward having a common national framework for endorsement of measures by a national consensus body (which currently is the National Quality Forum) and set expectations when accepting QCDR measures that measure stewards would be expected to get endorsement after a certain defined time period. Response: We will continue dialogue with QCDRs during our scheduled calls. As far as expanding our policy toward having a common national framework for endorsement of measures by a national consensus body, we agree this would be valuable and encourage QCDRs to have their measures NQF endorsed. However, it is not a necessary requirement at this time because of its potential increase in burden and potential unintended impacts on the ability of QCDRs to adapt their measures. Comment: A few commenters stated that CMS should work with both specialty societies and vendors in facilitating the time and effort needed to PO 00000 Frm 00067 Fmt 4701 Sfmt 4700 59901 successfully encourage reporting of specialty-specific process and outcome measures while ensuring proper review and that appropriate data can be collected and shared. One commenter suggested CMS develop a review process where CMS and its contractor consult with appropriate physician experts and QCDR stewards to ensure sufficient clinical expert review on the importance and relevancy of a measure. Response: We hold QCDR measure preview calls to provide a forum to work with both specialty societies and vendors wishing to self-nominate QCDR measures. New entities wishing to review QCDR measure concepts with CMS, may request a meeting with CMS by contacting the Quality Payment Program Service Center at QPP@ cms.hhs.gov. Existing QCDRs may contact our contractor support team to set up a QCDR measure preview call. We have several measure experts as part of our review process, many of which have specialty specific expertise. Furthermore, we hold calls prior to selfnomination to allow experts to discuss their QCDR measure concepts, and will also continue to schedule calls with QCDRs after the self-nomination period closes to provide feedback, which provides time for QCDRs to invite their clinical experts to provide additional information and explanation that would provide us with clarifications that may lead to a QCDR measure reexamination. Comment: Many commenters did not support the proposal to align QCDR measure requirements with the criteria used under the Call for Quality Measures Process due to their beliefs that applying this criteria to QCDR measures fails to recognize the unique role of QCDRs who fill critical gaps in traditional quality measure sets as they support different specialties, and that doing so would limit the number of measures available for QCDR participants, would create more stringent standards for QCDR measures resulting in additional burden, and be counterproductive toward the goal of encouraging the use of QCDRs. Commenters stated that rather than require these criteria, the criteria should be made optional, but strongly preferred, as there are existing evidencebased process measures that are still valuable to improving patient care and should still be considered for inclusion in the QCDR program; and that since some outcome measures which evaluate degenerative or rare incidences, conditions that are terminal with limited treatment options, or conditions which result in increased co-morbidities require measurement over the course of multiple years to have sufficient E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59902 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations statistical power, CMS should continue the use of certain process measures until they can be easily converted to meaningful outcome measures. Response: We believe that our process seeks to ensure reliable measures and expect all measures in the program, including QCDRs, to be held to that standard. We believe that it is imperative to raise the bar with QCDR measures in order to ensure that we move away from standard of care, lowbar, process, and/or duplicative measures. Specifically, we are considering proposing to require reliability and feasibility testing as an added criteria in order for a QCDR measure to be considered for MIPS in future rulemaking. In the CY 2018 Quality Payment Program final rule (82 FR 53814), we state that as the MIPS program progresses in its implementation, we are interested in elevating the standards for which QCDR measures are selected and approved for use. As a part of our QCDR measure review process, we do consider the complexity of what is being measured, while being mindful that measures with high performance do not provide value with regards to the quality performance category in MIPS. There are process measures in MIPS that are considered high priority, we believe it is important to retain those so long as they demonstrate room for improvement and lead to meaningful outcomes. Comment: One commenter suggested CMS clarify the process by which a measure would be assigned within the domains provided under the proposed alignment with the Call for Quality Measures process and offer greater transparency in the rationale for this assignment or outcome status. In addition, the commenter recommended that CMS defer to the rationale and status identified by the QCDR, in particular for clinician-led registries. Response: During the self-nomination process, we ask the QCDR to assign their QCDR measure a NQS domain, Meaningful Measure Area, whether or not their measure is high priority and/ or an outcome measure. As a part of the vetting process, we review those selections and will reach out to the QCDR should we not agree with their assignment. Comment: One commenter stated that due to the announcement of approved measures continuing to occur on a fixed schedule shortly before the start of each MIPS performance period despite the rolling submission process for new MIPS measures through the Call for Quality Measures Process, CMS should transition to a rolling review and approval process for QCDR measures to VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 allow stakeholders more time to implement new measures prior to the MIPS performance period. This commenter also stated that if CMS is unwilling to move to a rolling review and approval process, the quality category performance period should be reduced. The commenter noted that the rolling submission process has not benefited measure owners, QCDRs, registries, and EHR vendors, all of which have very little time to modify their systems to include new measures post-approval and prior to the start of the next MIPS performance period. Response: We note that a rolling review basis would adversely impact our ability to limit the number of duplicative measures that are similar in concept, which is inconsistent with the meaningful measure initiative. We believe that the change in the selfnomination period would allow for increased time in the measure review process, as well as provide additional time for QCDRs to respond to feedback provided by CMS. We do not believe a rolling review and approval process is appropriate, as it is not a process that is used for MIPS quality measures. We do not agree that the quality performance period should be reduced dependent on whether or not a rolling review and approval process is implemented as there is no correlation between the two processes. Comment: One commenter suggested CMS should require measure developers to include a section in each measure that specifies how eligible clinicians and TINs should be attributed for that measure to assist in preventing different interpretations for measure attribution which could lead to TIN/NPI mismatches and resulting determinations by CMS that submitted data is inaccurate. Response: We agree that attribution should be clearly stated in the QCDR measure specifications and appreciate the commenter’s feedback. We will take this suggestion into consideration as we review QCDR measure concepts, and will share this feedback with the QCDRs for their consideration. After consideration of the public comments received, we are finalizing our proposal to consolidate our previously finalized standards and criteria used for selecting and approving QCDR measures at § 414.1400(e) and (f) at § 414.1400(b)(3) and to apply certain criteria used under the Call for Quality Measures Process when considering QCDR measures for possible inclusion in MIPS beginning with the MIPS 2021 payment year. We are also finalizing our proposal to apply select criteria used under the Call for Measures Process, as PO 00000 Frm 00068 Fmt 4701 Sfmt 4700 described in the CY 2018 Quality Payment Program final rule (82 FR 53636) in addition to the QCDR measure criteria previously finalized at § 414.1400(f). Specifically, in addition to the QCDR measure criteria that we are finalizing at § 414.1400(b)(3), we are also finalizing our proposal to apply the following criteria beginning with the 2021 MIPS payment year when considering QCDR measures for possible inclusion in MIPS: • Measures that are beyond the measure concept phase of development. • Preference given to measures that are outcome-based rather than clinical process measures. • Measures that address patient safety and adverse events. • Measures that identify appropriate use of diagnosis and therapeutics. • Measures that address the domain for care coordination. • Measures that address the domain for patient and caregiver experience. • Measures that address efficiency, cost and resource use. • Measures that address significant variation in performance. (e) QCDRs Seeking Permission From Another QCDR To Use an Existing, Approved QCDR Measure In the CY 2018 Quality Payment Program final rule (82 FR 53813), we finalized that beginning with the 2018 performance period and for future program years, QCDR vendors may seek permission from another QCDR to use an existing measure that is owned by the other QCDR. We intended for this policy to help reduce the number of QCDR measures that are similar in concept or clinical topic, or duplicative of other QCDR measures that are being approved. Furthermore, having multiple QCDRs report on the same QCDR measure allows for a larger cohort of clinicians to report on the measure, which helps establish more reliable benchmarks and may give some eligible clinicians or group a better chance of obtaining a higher score on a particular measure. However, we have experienced that this policy has created unintended financial burden for QCDRs requesting permission from other QCDRs who own QCDR measures, as some QCDRs charge a fee for the use of their QCDR measures. MIPS quality measures, while stewarded by specific specialty societies or organizations, are generally available for third party intermediaries, MIPS eligible clinicians, and groups to report on for purposes of MIPS without a fee for use. Similarly, we believe, that once a QCDR measure is approved for reporting in MIPS, it should be generally available for other E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations QCDRs to report on for purposes of MIPS without a fee for use. In the CY 2019 PFS proposed rule (83 FR 35984), we proposed at § 414.1400(b)(3)(ii)(C) that beginning with the 2021 MIPS payment year, as a condition of a QCDR measure’s approval for purposes of MIPS, the QCDR measure owner would be required to agree to enter into a license agreement with CMS permitting any approved QCDR to submit data on the QCDR measure (without modification) for purposes of MIPS and each applicable MIPS payment year. In the CY 2019 PFS proposed rule (83 FR 35984) we also proposed at § 414.1400(b)(3)(iii) that other QCDRs would be required to use the same CMSassigned QCDR measure ID. If a QCDR refuses to enter into such a license agreement, the QCDR measure would be rejected and another QCDR measure of similar clinical concept or topic may be approved in its place. The following is a summary of the public comments received on the ‘‘QCDRs Seeking Permission from another QCDR to Use an Existing, Approved QCDR Measure’’ proposals and our responses: Comment: Many commenters disagreed with CMS’ proposal to require QCDRs to enter into a measure licensing agreement with CMS beginning with the 2021 MIPS payment year, stating that QCDRs would be required to attest to these measures before knowledge that this proposal would be finalized and that they, therefore, did not know that they would be required to enter into mandatory licensing agreements for these measures at the time of attestation. Commenters specifically stated that this timeline would violate the Administrative Procedure Act. Other commenters stated that should the proposal be finalized, it would be unreasonable for QCDR measure stewards to implement the policy by January 1 of the 2019 performance period given that the self-nomination period closes prior to publication of the CY 2019 PFS final rule. Commenters stated that the proposal, if it is finalized, should be delayed at least 1 year to give QCDRs an opportunity to decide whether to continue participating in the program. One commenter stated that some specialty societies may delay their QCDR application until this issue has been addressed by CMS. Response: Based on the feedback and concerns raised by stakeholders, in the interim, we are not finalizing this proposal. Rather, while we believe our proposal is consistent with the Administrative Procedure Act, we are persuaded by the other concerns raised by stakeholders on the implementation VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 of this policy and are therefore retaining our existing policy that QCDR vendors may seek permission from another QCDR to use an existing measure that is owned by the other QCDR (82 FR 53813). Comment: Many commenters disagreed with the proposal to require QCDR measure owners to allow other QCDRs to submit data on the QCDR measure as a condition of measure approval. Reasons cited for disagreeing with the proposal include beliefs that it does not acknowledge the cost in developing complex measures; would unfairly reduce costs for QCDRs that do not develop their own measures while increasing costs for QCDRs that do; would compromise the intellectual property of measure stewards as CMS would have a mandatory, exclusive, and unfettered right to sublicense their QCDR measures for MIPS purposes as a condition of measure approval; would undermine the smooth operation of the QCDR measure market; is an arbitrary and capricious reversal of existing policy; violates intellectual property law, judicial precedent, executive order, and copyrights; nullifies the rights of copyright owners to collect reasonable royalties, maintain measure integrity, and limit inappropriate use; might remove the right of QCDR developers to have input into how CMS uses their measures; may result in a developer having to seek CMS’s approval prior to working with another payer entity for reporting of its measures; and ignores the time and resources spent in developing and maintaining measures. Response: As noted above we are not finalizing this proposal. We note that we do not believe this proposal would have violated intellectual property rights or law, as QCDRs would not have been required to submit QCDR measures for approval, and if a QCDR had refused to enter into such a license agreement, the QCDR measure would have been rejected and another QCDR measure of similar clinical concept or topic may have been approved in its place. We will take the many concerns raised by commenters into consideration as we work with stakeholders to address this issue in the future. Comment: Many commenters disagreed with the proposal to require QCDR measure owners to allow other QCDRs to submit data on the QCDR measure as a condition of measure approval believing it contradicts the intent of the Meaningful Measure Initiative by eliminating the incentive to develop innovative quality measures that focus on meaningful outcomes; will disincentivize societies from investing in the development of new and PO 00000 Frm 00069 Fmt 4701 Sfmt 4700 59903 improved measures; may increase the incidence of inappropriate use of measures by QCDRs lacking the necessary clinical breadth of exposure/ experience resulting in lower quality data being collected, decreased reliability and validity of results, and potential misclassification of providers; would negatively impact the quality of available measures and physician community support for the Quality Payment Program in general; would disincentivize QCDRs from remaining in business, resulting in loss of significant private sector knowledge and experience, as well as increasing the financial burden on the government to hire more federal contractors to replace lost innovation and creativity; and disregards the original intent of QCDRs to submit data on non-MIPS measures focused on disease, condition, procedure, or therapy-specific patient populations. Response: We do not believe this proposed policy contradicts the Meaningful Measure Initiative, which seeks to reduce the number of duplicative measures in quality performance programs, thereby reducing clinician burden and complexity. However, as noted above we are not finalizing this proposal. We also note that with the finalization of the updated QCDR definition, we believe we will be able to negate any concerns of inappropriate use of QCDR measures by QCDRs who do not have the clinical expertise needed to understand the measure at hand. We have observed increasing interest in stakeholders becoming QCDRs, and believe that they will continue to drive innovation and competition within the market. Comment: A few commenters suggested alternatives to the proposal to require QCDRs to license their measures to CMS. These alternatives include encourage licensing agreements between QCDRs and reinforcing the ability of QCDRs to develop their own measures should they elect not to license them from other QCDRs. One commenter suggested that CMS should create a ‘‘measure complexity score’’ with a corresponding, volume-based, licensing fee payable to the QCDR holding the original measure in conjunction with an annual consolidation of measures to support harmonization requiring stakeholders to collaborate on a ‘‘shared’’ measure creation (with licensing fees split evenly) or lose the opportunity for future licensing fee payments. Another commenter recommended CMS propose including a cost-based algorithm that would be used to determine a specific QCDR measure fee which would protect organizations E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59904 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations that could not afford the development of a quality measure or that were not able to develop a measure because a similar measure exists, as well as preventing QCDR measure developers from assigning unreasonable fees to their measures. One commenter recommended CMS establish a pilot program that would encourage collaboration across QCDRs and require users of QCDR measures to agree to adhere to certain requirements of the measure steward, as well as share measure performance information to implement and test measure changes, progressing all concepts to patientcentered outcome measures through measure retirement. Another commenter recommended that CMS follow NQF’s example that anyone can report the measure scores and there has to be public/free access for the measures to be used in clinical care, but the measure steward should be permitted to require licensing and fees for anyone who wants to use the measures for more sophisticated purposes, such as programming into software that will result in sales/profit. Other commenters cited their opinions that should the proposal be finalized, it should be done with modification to require a standard data dictionary be used for all QCDR measures and include risk adjustment as well as the same standard methodology used by the measure developer. Response: We note that the suggestion to encourage licensing agreements between QCDRs was implemented in the CY 2018 Quality Payment Program final rule (82 FR 53813 through 53814); however, we have decided not to finalize the measure licensure policy at this time. Our goal in enacting such a policy was to promote measure harmonization and decrease the number of duplicative QCDR measures in the program. We appreciate the suggestion of a ‘‘measure complexity score’’ but envision such an approach would be difficult to implement. We would need additional information from stakeholders prior to implementing such a policy, such as how would CMS know how to correlate the volume and complexity to a specific score? What would that entail if on an annual basis the number of QCDRs who submit a similar measure concept increases, and what would they have to do in order to be a part of the harmonization effort? We request clarification on how a costbased algorithm can be developed, and would also like to clarify that CMS does not regulate the minimum or maximum amounts that a QCDR may charge as a licensing fee. We thank the commenter for their suggestion of implementing a pilot VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 program where QCDRs would need to share measure performance information, test and implement measure changes, and work towards patient-centered outcome measures. We agree that the sharing of performance data, testing results, and moving towards outcome based measures are all important, but will need to look into the feasibility and operations of implementing such requirements. With regards to the development of a standard data dictionary, as described in the CY 2018 Quality Payment Program final rule (82 FR 53813), we encourage QCDR measure developer to utilize the current Measure Development Plan available at https://www.cms.gov/Medicare/QualityPayment-Program/MeasureDevelopment/2018-MDP-annualreport.PDF. Furthermore, as explained through posted sub-regulatory documents for the 2019 self-nomination period, the current Blueprint for the CMS Measures Management System available at https://www.cms.gov/ Medicare/Quality-Initiatives-PatientAssessment-Instruments/MMS/ Downloads/BlueprintVer14.pdf. Both resources provide information on standardized terminology, measure concepts and constructs. Comment: Many commenters requested CMS work with them to adopt a market-based solution to create safeguards to protect the proper implementation of QCDR measures and enforce the intellectual property rights of developers of QCDR measures, while also ensuring that the measures are readily available to other QCDRs with clinical expertise and experience in quality measure development. Response: We will look to provide listening sessions to better understand and explore the feasibility of this approach. Comment: Many commenters expressed concern with CMS’ requests for harmonization of similar MIPS measures due to their belief that some vendors may be misusing measures and diminishing the integrity of the data, the quality of feedback to physicians, and ability to compare performance. The commenters further cited their belief that such harmonization can lead to inconsistencies in implementation, yielding incomparable results and inaccurate benchmarking due to lack of accountability and standardization across registries which may be employing different methods for obtaining, risk adjusting, and aggregating data, thereby creating variations in how clinicians are measured and how their care is classified. PO 00000 Frm 00070 Fmt 4701 Sfmt 4700 Response: To clarify, in the CY 2019 PFS proposed rule (83 FR 35984), we indicated that the QCDRs would be required to use the QCDR measure without any modification, and would have to report on the measure utilizing the CMS assigned measure ID. We encourage QCDRs to work together through measure harmonization, and to reach out to QCDR measure owners when they believe a revision to the measure specification is appropriate, for the QCDR measure owner to consider. Comment: A few commenters suggested the proposal to require QCDRs to license measures to CMS should include allowing qualified registries and other non-QCDR submitter types to also report QCDR measures; only counting measures developed by a QCDR to count toward the 30 measure threshold; and requiring QCDR measure owners to provide detailed specifications including ICD– 10–CM codes, CPT codes, required clinical data elements, et cetera, so that all QCDR registries administer the specification uniformly, and developing a system to properly record and track ownership rights, including making ownership information CMS collects available to QCDRs to better facilitate sharing of QCDR measures between QCDR stewards. Commenters also suggested that CMS reserve the right of the measure owner to review interim performance results of other QCDRs utilizing their measures with full cooperation of the other QCDRs to ensure performance results do not vary significantly between QCDRs, thereby ensuring alignment on execution of the measure specification between QCDRs before performance is scored and future benchmarks are impacted. Response: To clarify, we are only allowing other QCDRs to report on the QCDR measures. Other submitter types would not have the QCDR measures available for reporting. As discussed in the CY 2018 Quality Payment Program final rule (82 FR 53811), QCDRs have the capability to develop and submit for consideration up to 30 QCDR measures per performance period. However, there is no limit as to the number of MIPS quality measures they intend on supporting for a given performance period. We disagree that QCDR measures should be available for reporting by non-QCDR submitter types. As we provide QCDRs with feedback on harmonizing or using QCDR measures owned by other QCDRs, we encourage them to reach out to the QCDRs specifically for the detailed specification inclusive of ICD–10 and CPT codes, as each measure owner is responsible for tracking ownership E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations rights. The MIPS quality measures provide a detailed measure specification to allow consistency in implementation, but data abstraction may include multiple methods. We would require QCDRs to follow a similar approach, where QCDRs would need to provide a detailed specification to the QCDRs approved to submit the QCDR measure. This would include any applicable ICD– 10–CM codes, CPT codes, required clinical data elements, et cetera, to allow implementation with minimal variance. We would like to hear from QCDRs on whether or not they would find this useful; and if this effort will increase burden on their end regarding measure specification development. We will take the suggestion that CMS reserve the right of the measure owner to review interim performance results of other QCDRs utilizing their measures into consideration for future rulemaking. Comment: A few commenters stated that the proposal blurs the line between QCDR measures and Quality Payment Program measures and would eliminate the ability for a QCDR to ‘‘test’’ a measure in the sandbox of their own QCDR before submitting it to CMS to become a Quality Payment Program measure under the Measures Under Consideration (MUC) process. Finally, one commenter suggested that if a measure owner was ready to make a measure available for reporting by all of the Quality Payment Program, they should submit it to CMS under the MUC process. Response: The QCDR measure approval process is not intended to act as a test bed for measure concepts, we expect QCDRs to have measures that are analytically sound, are reliable, and feasible. Furthermore, we certainly encourage that if a measure owner is ready to make a measure available for reporting by all of the Quality Payment Program, they should submit it to CMS under the MUC process as discussed in section III.I.3.h.(2)(b)(i) of the CY 2019 PFS proposed rule (83 FR 35898 through 35899). Comment: One commenter stated its belief that the proposal does not align with the intended purpose of the MACRA grant for measure development, which they further noted demonstrates the federal government’s recognition of measure development expense. A second commenter stated that the proposal lacks provisions on how to determine whether a specific measure is intended for another population and that the absence of such provisions can lead to inappropriate implementations in patient populations with the inability of the measure owner to review data VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 collected on their measures and maintain the measures appropriately. Response: We do not believe this policy would not align with the MACRA grant for measure development, since generally across all quality programs we are looking to reduce the number of duplicative measures available for reporting and to transition to more outcomes based measures. We believe that QCDRs exist to address measurement gaps as identified by the specialists and that QCDRs are intended to address gaps in measurement that would better reflect a clinician’s scope of practice. Based on the updates to the QCDR definition we have finalized in this final rule (in the above section) for the 2020 performance period of MIPS, we believe we will be able to further vet QCDR applications to ensure that approved QCDRs would have the clinical expertise and measure development experience. We are also streamlining the number of measures available to clinicians in order to align with our Meaningful Measures initiative. We note that our review and approval of the QCDR measures will follow our existing process utilizing the QCDR measure evaluation criteria as detailed through sub-regulatory guidance in the 2019 QCDR Measure Development Handbook, located in the 2019 Self-Nomination Toolkit on the Quality Payment Program Resource Library web page at https:// www.cms.gov/Medicare/QualityPayment-Program/Resource-Library/ 2018-Resources.html. Once the QCDR measures have been finalized for the performance period, and the specification has been finalized, we intend to post the list of QCDR measure specifications for QCDRs to review and consider prior to deciding whether or not they wish to support additional QCDR measures. As a part of this consideration, we encourage QCDRs to review the measure specifications to determine the populations addressed. Comment: A few commenters supported the proposal to require QCDRs to enter into licensing agreements with CMS as a condition of approval. Reasons cited include their beliefs that the proposal allows different vendors to have the ability to address different specialty needs appropriately thereby providing greater choice to eligible clinicians, increases the effectiveness of quality measurement, and increases the relevance and usefulness of measures in evaluating the quality of care provided to patients nationally by increasing the number of providers reporting data. Response: We thank the commenters for their support but as noted previously PO 00000 Frm 00071 Fmt 4701 Sfmt 4700 59905 we are not finalizing this policy at this time. Comment: A few commenters stated that CMS should adopt a model where one measure is supported by one entity that represents a single clinical domain or subspecialty as they noted doing so will enhance consistency and validity across measurements; allow for a single method for data aggregation, analytics, and reporting; reduce benchmarking issues; decrease the risk of clinicians being misclassified in the quality of care they provide; and remedy CMS’ lack of ability to co-aggregate data from multiple data sources and properly riskadjust measures. The commenters noted that the approved registry should be required to meet standards for data which include rigor in explicitly defining data elements used in the measurement, serve as a single source of data aggregation and data normalization to secure data integrity, apply approved and consistent statistical standards for analytics, respond to clinical and methodological questions, and be responsible for reporting requirements as defined by CMS. One commenter further noted that CMS policy should require QCDRs to always refer eligible clinician questions on specific measures back to the measure steward, prohibit vendors and other QCDRs from specifying CQMs into eCQMs without permission, require QCDRs to use current measure specifications, and require CMS to publicly post complete measure specifications, where appropriate, to the CMS Quality Payment Program resources website to ensure all registries are implementing the most updated measure specifications. Response: We are not looking to set limitations, such as, one clinical domain being assigned to one entity. We have multiple instances where there are a few QCDRs covering similar areas (that is, surgery, anesthesia, rheumatology). We would appreciate thoughts on how we can reduce benchmarking issues to thereby incentivize QCDR measure reporting. QCDRs are required to meet CMS data aggregation and reporting requirements and agree that it is important that QCDRs are able to meet data integrity standards in using data elements for purposes of measurement. We believe there are circumstances out of CMS’ control where the clinician will reach out to the QPP service center for assistance with a measure related question or to the QCDR they are specifically working with. It would not be feasible to set such a requirement when we could not monitor that it would be followed. We encourage clinicians who have questions on the E:\FR\FM\23NOR3.SGM 23NOR3 59906 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations amozie on DSK3GDR082PROD with RULES3 QCDR measure specifications to reach out directly to the QCDR measure owner in order to gain clarity on their questions. We agree, however, that the QCDR must use the measure in its original state. QCDRs have to use the measure in its ‘‘as is’’ state; meaning, how it was approved for the given performance period. We post QCDR measure specifications, inclusive of: The measure’s specialty; QCDR name; measure title; measure description; denominator; numerator; denominator exclusions; denominator exceptions; numerator exclusions; data source used; NQF number (if applicable); NQS domain; whether the measure is high priority, outcome; measure type; whether the measure is inverse, proportional, continuous variable, ratio; the range of scores if the measure is continuous variable or ratio measures; number of performance rates submitted; overall performance rate; whether the measure is risk-adjusted; if riskadjusted, and which score is riskadjusted within the QPP resource library. The systems are programmed on an annual basis to only accept those QCDR measures and correlated specifications as approved for the upcoming performance period. Based on the feedback and concerns raised by stakeholders, in the interim, we are not finalizing at § 414.1400(b)(3)(ii)(C) that as a condition of a QCDR measure’s approval for purposes of MIPS, the QCDR measure owner would be required to agree to enter into a license agreement with CMS, permitting any approved QCDR to submit data on the QCDR measure (without modification) for purposes of MIPS and each applicable MIPS payment year. Rather we are retaining our existing policy that QCDR vendors may seek permission from another QCDR to use an existing measure that is owned by the other QCDR (82 FR 53813). We remain very concerned about duplicative measures and their impact to our meaningful measures initiative. We are eager to work with the stakeholder community to determine solutions for this issue and will continue to look for policy resolutions to address this issue. We are finalizing our proposal at § 414.1400(b)(3)(iii) that other QCDRs would be required to use the same CMSassigned QCDR measure ID. (4) Qualified Registries We refer readers to § 414.1400 and the CY 2018 Quality Payment Program final rule (82 FR 53815 through 53818) for our previously finalized policies regarding qualified registries. In the CY 2019 PFS proposed rule (83 FR 35984), VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 we proposed to update: Information required for qualified registries at the time of self-nomination and the selfnomination period for qualified registries. (a) Establishment of an Entity Seeking To Qualify as a Qualified Registry In the CY 2017 Quality Payment Program final rule (81 FR 77383), we state at § 414.1400(h)(2) that the qualified registry must have at least 25 participants by January 1 of the performance period. These participants do not need to use the qualified registry to report MIPS data to us; rather, they need to submit data to the qualified registry for quality improvement. We realize that a qualified registry’s lack of preparedness to accept data from MIPS eligible clinicians and groups beginning on January 1 of the performance period may negatively impact a clinician’s ability to use a Qualified Registry to report, monitor the quality of care they provide to their patients (and act on these results) and may inadvertently increase clinician burden. For these reasons, in the CY 2019 PFS proposed rule (83 FR 35984), we proposed to redesignate § 414.1400(h)(2) as § 414.1400(c)(2) to state that beginning with the 2022 MIPS Payment Year, the qualified registry must have at least 25 participants by January 1 of the year prior to the applicable performance period. These participants do not need to use the qualified registry to report MIPS data to us; rather, they need to submit data to the qualified registry for quality improvement. We did not receive any comments on the ‘‘Establishment of an Entity Seeking To Qualify as a Qualified Registry.’’ We are finalizing our proposal to redesignate § 414.1400(h)(2) as § 414.1400(c)(2) to state that beginning with the 2022 MIPS Payment Year, the qualified registry must have at least 25 participants by January 1 of the year prior to the applicable performance period. (b) Self-Nomination Process We refer readers to § 414.1400(g), the CY 2017 and CY 2018 Quality Payment Program final rules (81 FR 77383 and 82 FR 53815, respectively) for our previously established policies regarding the self-nomination process for qualified registries. We did not propose any changes to this policy. (c) Self-Nomination Period Under the previously finalized policy at § 414.1400(g), qualified registries must self-nominate from September 1 of the year prior to the applicable performance period until November 1 of PO 00000 Frm 00072 Fmt 4701 Sfmt 4700 the same year and must, among other things, provide all information requested by us at the time of selfnomination. To maintain alignment with the timelines proposed for QCDR self-nomination, as discussed in section III.I.3.k.(3)(c) of this final rule, we also proposed in the CY 2019 PFS proposed rule (83 FR 35985) to update the selfnomination period from September 1 of the year prior to the applicable performance period until November 1 to July 1 of the calendar year prior to the applicable performance period until September 1. Specifically, we proposed in the CY 2019 PFS proposed rule (83 FR 35985) at § 414.1400(c)(1) that, beginning with the 2022 MIPS payment year, entities seeking to qualify as qualified registries must self-nominate during a 60-day period beginning on July 1 of the calendar year prior to the applicable performance period and ending on September 1 of the same year; must provide all information required by us at the time of self-nomination; and must provide any additional information requested by us during the review process. For example, for the 2022 MIPS payment year, the applicable performance period would be CY 2020, as discussed in section III.I.3.g. of this final rule. Therefore, the selfnomination period for qualified registries would begin on July 1, 2019 and end on September 1, 2019. We did not receive any comments on the ‘‘Self-nomination Period’’ for Qualified Registries. We are finalizing our proposal to amend § 414.1400(c)(1) to provide that, beginning with the 2022 MIPS payment year, entities seeking to qualify as qualified registries must selfnominate during a 60-day period beginning on July 1 of the calendar year prior to the applicable performance period and ending on September 1 of the same year; must provide all information required by us at the time of self-nomination; and must provide any additional information requested by us during the review process. (5) Health IT Vendors or Other Authorized Third Parties That Obtain Data From MIPS Eligible Clinicians’ Certified EHR Technology (CEHRT) We refer readers to § 414.1400 and the CY 2017 Quality Payment Program final rule (81 FR 77377 through 77382) for our previously finalized policies regarding health IT vendors or other authorized third parties that obtain data from MIPS eligible clinicians. We finalized that health IT vendors that obtain data from a MIPS eligible clinician, like other third party intermediaries, would have to meet all criteria designated by us as a condition E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations amozie on DSK3GDR082PROD with RULES3 of their qualification or approval to participate in MIPS as a third party intermediary. This includes submitting data in the form and manner specified by us. In the CY 2019 PFS proposed rule (83 FR 35985), we proposed to codify these policies at § 414.1400(d). Although we specified criteria for a health IT vendor in the CY 2017 Quality Payment Program final rule, we failed to codify the definition of a health IT vendor. Therefore, in the CY 2019 PFS proposed rule (83 FR 35985), we proposed to define at § 414.1305, that health IT vendor means an entity that supports the health IT requirements on behalf of a MIPS eligible clinician (including obtaining data from a MIPS eligible clinician’s CEHRT). As indicated in footnote 1 of the CY 2017 Quality Payment Program final rule (81 FR 77014 through 77015), the term ‘‘health IT vendor’’ encompasses many types of entities that support the health IT requirements on behalf of a MIPS eligible clinician. A ‘‘health IT vendor’’ may or may not also be a ‘‘health IT developer’’ for the purposes of the ONC Health IT Certification Program (Program), and, in some cases, the developer and the vendor of a single product may be different entities. Under the Program, a health IT developer constitutes a vendor, self-developer, or other entity that presents health IT for certification or has health IT certified under the Program. Other health IT vendors may maintain a range of data transmission, aggregation, and calculation services or functions, such as organizations which facilitate health information exchange. We did not receive any comments on the ‘‘Health IT Vendors or Other Authorized Third Parties That Obtain Data From MIPS Eligible Clinicians’ Certified EHR Technology (CEHRT).’’ Therefore, we are finalizing our proposal to codify our previously established policies at § 414.1400(d). We are also finalizing our proposal to define at § 414.1305, that health IT vendor means an entity that supports the health IT requirements on behalf of a MIPS eligible clinician (including obtaining data from a MIPS eligible clinician’s CEHRT). (6) CMS-Approved Survey Vendors In the CY 2017 Quality Payment Program final rule (81 FR 77386), we finalized the criteria, required forms, and vendor business requirements needed to participate in MIPS as a CMSapproved survey vendor. In the CY 2019 PFS proposed rule (83 FR 35985), we proposed at § 414.1400(e) to codify these previously finalized criteria and requirements. Accordingly, we VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 proposed in the CY 2019 PFS proposed rule (83 FR 35985) at § 414.1400(e) that an entity seeking to be a CMS-approved survey vendor for any MIPS performance period must submit a survey vendor application to CMS in a form and manner specified by CMS for each MIPS performance period for which it wishes to transmit such data. We also proposed to require that the application and any supplemental information requested by CMS must be submitted by deadlines specified by CMS. In addition, we proposed that a CMS-approved survey vendor must meet several criteria. First, we proposed to require that an entity have sufficient experience, capability, and capacity to accurately report CAHPS data, including: • At least 3 years of experience administering mixed-mode surveys (surveys that employ multiple modes to collect data) that include mail survey administration followed by survey administration via Computer Assisted Telephone Interview (CATI); • At least 3 years of experience administering surveys to a Medicare population; • At least 3 years of experience administering CAHPS surveys within the past 5 years; • Experience administering surveys in English and one of the following languages: Cantonese; Korean; Mandarin; Russian; or Vietnamese; • Use of equipment, software, computer programs, systems, and facilities that can verify addresses and phone numbers of sampled beneficiaries, monitor interviewers, collect data via CATI, electronically administer the survey and schedule callbacks to beneficiaries at varying times of the day and week, track fielded surveys, assign final disposition codes to reflect the outcome of data collection of each sampled case, and track cases from mail surveys through telephone follow-up activities; and • Employment of a program manager, information systems specialist, call center supervisor and mail center supervisor to administer the survey. Furthermore, we proposed in the CY 2019 PFS proposed rule (83 FR 35985) that to be a CMS-approved survey vendor, the entity must also meet the following criteria: • It must have certified that it has the ability to maintain and transmit quality data in a manner that preserves the security and integrity of the data; • The entity must have successfully completed, and required its subcontractors to successfully complete, vendor training(s) administered by CMS or its contractors; PO 00000 Frm 00073 Fmt 4701 Sfmt 4700 59907 • The entity must have submitted a quality assurance plan and other materials relevant to survey administration, as determined by CMS, including cover letters, questionnaires and telephone scripts; • The entity must have agreed to participate and cooperate, and have required its subcontractors to participate and cooperate, in all oversight activities related to survey administration conducted by CMS or its contractors; and • The entity must have sent an interim survey data file to CMS that establishes the entity’s ability to accurately report CAHPS data. We also refer readers to the CY 2018 Quality Payment Program final rule (82 FR 53818 through 53819) for our previously established policies regarding the updated survey vendor application deadline. The following is a summary of the public comments received on the ‘‘CMSApproved Survey Vendors’’ proposals and our responses: Comment: A few commenters commended CMS for making the CAHPS for Physician Quality Reporting System (PQRS) survey available in Cantonese, Korean, Mandarin, Russian, Spanish, and Vietnamese and for making the Medicare Accountable Care Organization CAHPS survey available in Cantonese, Korean, Mandarin, Portuguese, Russian, Spanish, and Vietnamese. These commenters encouraged CMS to work with stakeholders to develop validated translations of all CAHPS surveys used in MIPS and APMs in at least the top ten primary languages among Medicare beneficiaries. Response: We appreciate the commenters’ feedback. We have made the CAHPS for MIPS survey available in Spanish and we will continue to work with stakeholders to develop additional translations of the surveys. In addition, because the CAHPS for MIPS survey is available in Spanish and may become available in other languages in the future, we believe it is appropriate to modify our proposed requirement at § 414.1400(e)(1)(iv) to more broadly state that an entity must have experience administering surveys in English and at least one other language for which a translation of the CAHPS for MIPS survey is available. These languages currently consist of Cantonese, Korean, Mandarin, Russian, Spanish, and Vietnamese. After consideration of the public comments received, we are finalizing our proposal at § 414.1400(e) to state that entities seeking to be a CMSapproved survey vendor for any MIPS E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59908 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations performance period must submit a survey vendor application to CMS in a form and manner specified by CMS for each MIPS performance period for which it wishes to transmit such data; and that the application and any supplemental information requested by CMS must be submitted by deadlines specified by CMS. We are also finalizing our proposal at § 414.1400(e) that a CMS-approved survey vendor must meet several criteria that consists of the following: An entity must have sufficient experience, capability, and capacity to accurately report CAHPS data, including: • At least 3 years of experience administering mixed-mode surveys (surveys that employ multiple modes to collect data) that include mail survey administration followed by survey administration via Computer Assisted Telephone Interview (CATI); • At least 3 years of experience administering surveys to a Medicare population; • At least 3 years of experience administering CAHPS surveys within the past 5 years; • Experience administering CAHPS surveys in English and at least one other language for which a translation of the CAHPS for MIPS survey is available. These languages currently consist of Cantonese, Korean, Mandarin, Russian, Spanish or Vietnamese; • Use of equipment, software, computer programs, systems, and facilities that can verify addresses and phone numbers of sampled beneficiaries, monitor interviewers, collect data via CATI, electronically administer the survey and schedule callbacks to beneficiaries at varying times of the day and week, track fielded surveys, assign final disposition codes to reflect the outcome of data collection of each sampled case, and track cases from mail surveys through telephone follow-up activities; and • Employment of a program manager, information systems specialist, call center supervisor and mail center supervisor to administer the survey. In addition, we are finalizing without change our proposal that an entity must have certified that it has the ability to maintain and transmit quality data in a manner that preserves the security and integrity of the data; the entity must have successfully completed, and has required its subcontractors to successfully complete, vendor training(s) administered by CMS or its contractors; the entity must have submitted a quality assurance plan and other materials relevant to survey administration, as determined by CMS, VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 including cover letters, questionnaires and telephone scripts; the entity must have agreed to participate and cooperate, and have required its subcontractors to participate and cooperate, in all oversight activities related to survey administration conducted by CMS or its contractors; and the entity must have sent an interim survey data file to CMS that establishes the entity’s ability to accurately report CAHPS data. (7) Auditing of Third Party Intermediaries Submitting MIPS Data In the CY 2018 Quality Payment Program final rule (82 FR 53819), we established at § 414.1400(j) policies regarding auditing of third party intermediaries submitting MIPS data. In the CY 2019 PFS proposed rule (83 FR 35985), we did not propose any changes to these policies. In this final rule, the provision that currently appears at § 414.1400(j) is redesignated as § 414.1400(g) and contains no substantive changes. (8) Remedial Action and Termination of Third Party Intermediaries In the CY 2017 Quality Payment Program final rule (81 FR 77548), we finalized the criteria for probation and disqualification for third party intermediaries at § 414.1400(k). In the CY 2019 PFS proposed rule (83 FR 35986), we proposed to revise the numbering of this section and the title to more accurately describe the policies in this section. Specifically, we proposed to renumber this section as § 414.1400(f) and to rename it as ‘‘remedial action and termination of third party intermediaries.’’ Additionally, we proposed in the CY 2019 PFS proposed rule (83 FR 35986) changes to § 414.1400(f) to amend, clarify, and streamline our policies related to remedial action and termination. Our intent with these policies is to identify and remedy noncompliance with the applicable third party intermediary criteria, as well as identify issues that may impact the accuracy of or our ability to use the data submitted by third party intermediaries. Accordingly, in the CY 2019 PFS proposed rule (83 FR 35986), we proposed to amend § 414.1400(f)(1) to state that we may take remedial action for noncompliance with applicable third party intermediary criteria for approval (a deficiency) or for the submission of inaccurate, unusable, or otherwise compromised data. In the CY 2017 Quality Payment Program final rule, we finalized our policy regarding data inaccuracies at § 414.1400(k)(4). In the PO 00000 Frm 00074 Fmt 4701 Sfmt 4700 CY 2019 PFS proposed rule (83 FR 35986), we proposed at § 414.1400(f)(3) to expand data inaccuracies to include a determination by us that data is inaccurate, unusable, or otherwise compromised. However, we did not propose to change the factors we may consider to make such a determination. In the CY 2019 PFS proposed rule (83 FR 35986), we also proposed to move the notification requirement at § 414.1400(k)(6) to § 414.1400(f)(1) and to apply the requirement to all deficiencies and data errors. Based on our early experience with third party intermediaries under MIPS and the challenges for both third party intermediaries and us in regards to timing and trying to resolve deficiencies and data errors within the various reporting and performance periods, we proposed in the CY 2019 PFS proposed rule (83 FR 35986) to amend the timeframes by which a third party intermediary must submit a Corrective Action Plan (CAP) to us or come into compliance. Specifically, we proposed § 414.1400(f)(2), which requires third party intermediaries to submit a CAP or correct the deficiencies or data errors by the date specified by us (83 FR 35986). Additionally, we proposed in the CY 2019 PFS proposed rule (83 FR 35986) to consolidate at § 414.1400(f)(1) the grounds for remedial action against a third party intermediary currently specified at § 414.1400(k)(1) and (4) and to consolidate at § 414.1400(f)(2) the grounds for terminating a third party intermediary currently found at § 414.1400(k)(3), (5) and (7). Therefore, we proposed at § 414.1400(f)(1) that if at any time we determine that a third party intermediary has ceased to meet one or more of the applicable criteria for approval, or has submitted data that is inaccurate, unusable, or otherwise compromised, we may take certain remedial actions (for example, request a CAP) (83 FR 35986). In the CY 2019 PFS proposed rule (83 FR 35986), we also proposed at § 414.1400(f)(2) that we may terminate, immediately or with advance notice, the ability of a third party intermediary to submit MIPS data on behalf of a MIPS eligible clinician, group, or virtual group for one or more of the following reasons: We have grounds to impose remedial action, we have not received a CAP within the specified time period or the CAP is not accepted by us, or the third party intermediary fails to correct the deficiencies or data errors by the date specified by us. Additionally, in the CY 2019 PFS proposed rule (83 FR 35986), we proposed to consolidate at § 414.1400(f)(1) the actions we may take E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations if we identify a deficiency or data error that are set forth at § 414.1400(k)(3) and (7). Thus, we proposed at § 414.1400(f)(1) in the CY 2019 PFS proposed rule (83 FR 35986) that if we determine a third party intermediary has ceased to meet one or more of the applicable criteria for approval, or has submitted data that is inaccurate, unusable, or otherwise compromised, we may require the third party intermediary to submit a CAP to us to address the identified deficiencies or data issue, including the actions it will take to prevent the deficiencies or data issues from recurring. We proposed to require that the CAP be submitted to CMS by a date specified by CMS. In the CY 2019 PFS proposed rule (83 FR 35986), we also proposed that CMS may determine that submitted data is inaccurate, unusable, or otherwise compromised if the submitted data: (1) Includes, without limitation, TIN/NPI mismatches, formatting issues, calculation errors, or data audit discrepancies; and (2) affects more than 3 percent (but less than 5 percent) of the total number of MIPS eligible clinicians or group for which data was submitted by the third party intermediary. In addition, we proposed in the CY 2019 PFS proposed rule (83 FR 35986) that if the third party intermediary has a data error rate of 3 percent or more, we will publicly disclose the entity’s data error rate on the CMS website until the data error rate falls below 3 percent. We clarify in this final rule that CMS may determine that submitted data is inaccurate, unusable, or otherwise compromised if the submitted data affects more than 3 percent of the total number of MIPS eligible clinicians or group for which data was submitted by the third party intermediary. In the CY 2017 Quality Payment Program final rule (81 FR 77387 through 77388), we explained that if a third party intermediary has data inaccuracies including (but not limited to) TIN/NPI mismatches, formatting issues, calculation errors, data audit discrepancies affecting in excess of 3 percent (but less than 5 percent) of the total number of MIPS eligible clinicians or groups submitted by the third party intermediary, we would annotate on the CMS qualified posting that the third party intermediary furnished data of poor quality and would place the entity on probation for the subsequent MIPS performance period. If a third party intermediary does not reduce their data error rate below 3 percent for the subsequent performance period, the third party intermediary would continue to be on probation and have their listing on the CMS website VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 continue to note the poor quality of the data they are submitting for MIPS for one additional performance year. After 2 years on probation, the third party intermediary would be disqualified for the subsequent performance year. We also explained that data errors affecting in excess of 5 percent of MIPS eligible clinicians or group submitted by the third party intermediary may lead to the disqualification of the third party intermediary from participation for the following performance period (that is, without first placing the third party intermediary on probation). Accordingly, it was always our intent that data errors affecting in excess of 3 percent of the MIPS eligible clinicians or group submitted by a third party intermediary would result in remedial action or disqualification (termination) of the third party intermediary. In this final rule, we are correcting an obvious error in the regulation text we proposed at § 414.1400(f)(3)(ii) to clarify that if submitted data is inaccurate, unusable, or otherwise compromised if errors in the submitted data affect more than 3 percent of the total number of MIPS eligible clinicians or group for which data was submitted by the third party intermediary. Finally, we proposed to remove our probation policy. Therefore, we proposed in the CY 2019 PFS proposed rule (83 FR 35986) to remove the definition of probation at § 414.1400(k)(2) and references to probation in § 414.1400(k)(1), (3) and (5). The following is a summary of the public comments received on the ‘‘Remedial Action and Termination of Third Party Intermediaries’’ proposals and our responses: Comment: One commenter stated that CMS should put in place a safe harbor policy in order to minimize the impact on clinicians when a data issue outside of a clinician’s or group’s control occurs due to a third party intermediary. The commenter indicated that, under those circumstances, CMS should automatically consider the clinician or group to have satisfied the quality performance category. The commenter cited concerns with the transition and upgrade to 2015 CEHRT and references data issues under 2016 PQRS related to the 2014 CEHRT upgrade. Response: We do not agree that we should create a safe harbor policy to address the circumstances described by the commenter. Instead, we believe it would be appropriate to address data issues on a case-by-case basis. As we discussed in the CY 2018 Quality Payment Program final rule (82 FR 53807), we expect third party PO 00000 Frm 00075 Fmt 4701 Sfmt 4700 59909 intermediaries to develop processes to ensure that the data and information they submit to CMS on behalf of MIPS eligible clinicians, groups, and virtual groups are true, accurate, and complete; we also rely on the third party intermediaries to address these issues in its arrangements and agreements with other entities, including MIPS eligible clinicians, groups, and virtual groups. Comment: One commenter agreed with the proposal to remove the probation policy. Response: We appreciate the commenter’s support. Comment: A few commenters disagreed with our proposal at § 414.1400(f)(2) because it would allow us to immediately or with advance notice terminate a third party intermediary’s ability to submit MIPS data without first placing the third party intermediary on probation. The commenters believe that termination should occur only with advance notice through a clearly defined process that reflects the current procedure set forth at § 414.1400(f). Commenters suggested that CMS’ termination procedure include formal consideration of a CAP. Response: We appreciate the commenters’ concerns, and therefore, we expect that in most circumstances, we would take remedial action, including imposition of a CAP, prior to terminating the ability of a third party intermediary to submit MIPS data on behalf of a MIPS eligible clinician, group, or virtual group. Before deciding whether to terminate a third party intermediary’s ability to submit MIPS data, we would take into account a third party intermediary’s actions, the severity of the non-compliance or errors at issue, and the potential for undue hardship or negative impact on affected eligible clinicians. In addition, we would expect to provide advance notice of most terminations; we would likely impose immediate termination on a third party intermediary’s ability to submit MIPS data only in circumstances where egregious non-compliance or data errors have occurred. However, if we have not received a CAP within the specified time period or the CAP is not accepted by us, or the third party intermediary fails to correct the deficiencies or data errors by the date specified by us, we may terminate the third party intermediary, immediately or with advance notice. Comment: A few commenters stated that the proposed termination policy could result in undue hardship on or negatively impact affected eligible clinicians should termination occur during a performance period. E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59910 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations Response: We recognize that termination of a third party intermediary’s ability to submit MIPS data during a performance period may result in undue hardship on eligible clinicians who are supported by the third party intermediary. Therefore, we would consider whether a third party intermediary is supporting eligible clinicians in deciding when to terminate the ability of the third party intermediary to submit MIPS data. In addition, we will consider for future rulemaking whether a third party intermediary should be required to submit to CMS a transition plan that addresses how submission of data would be handled in the event that termination occurs during a performance period. Comment: A few commenters representing QCDRs and qualified registries stated that CMS should clearly define, and provide examples of, a ‘‘data error’’ for purposes of determining a third party intermediary’s data error rate, which may be disclosed publicly by CMS if it exceeds 3 percent. In addition, the commenters stated that CMS should set forth how the data error rate is calculated and develop a report that describes and differentiates data errors and other ‘‘issues’’ that should be brought to a third party intermediary’s attention. Response: The ‘‘data error rate’’ measures the amount of data submitted by a third party intermediary that was ‘‘inaccurate, unusable, or otherwise compromised.’’ Additional material regarding data inaccuracies and error rates is available in the ‘‘2019 Qualified Clinical Data Registry (QCDR) Fact Sheet’’ and the ‘‘2019 Qualified Registry Fact Sheet’’ in the 2019 Self-Nomination Toolkit for QCDRs & Registries, located in the Quality Payment Program Resource Library at https:// www.cms.gov/Medicare/QualityPayment-Program/Resource-Library/ 2018-Resources.html. We appreciate the suggestion of creating a report that describes data errors and ‘‘other issues,’’ however, we believe that our existing material addresses the commenters’ concern. After consideration of the public comments received, we are finalizing our proposal to revise the numbering of § 414.1400(k) as § 414.1400(f) and to rename it as ‘‘remedial action and termination of third party intermediaries.’’ We are also finalizing our proposal to amend, clarify, and streamline our policies related to remedial action and termination as follows: • We are finalizing § 414.1400(f)(1) to state that CMS may take one or more of VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 the following remedial actions if we determine that a third party intermediary has ceased to meet one or more of the applicable third party intermediary criteria for approval or has submitted data that is inaccurate, unusable, or otherwise compromised: We will require the third party intermediary to submit by a deadline specified by CMS a CAP that addressed the identified deficiencies or data issue, including the actions it will take to prevent the deficiencies or data issues from recurring; or we will publicly disclose the entity’s data error rate on the CMS website until the data error rate falls below 3 percent. • We are finalizing § 414.1400(f)(2) to state that CMS may immediately or with advance notice terminate the ability of a third party intermediary to submit MIPS data on behalf of a MIPS eligible clinician group, or virtual group for one or more of the following reasons: CMS has grounds to impose remedial action; CMS has not received a CAP within the specified time period or the CAP is not accepted by CMS; or, the third party intermediary fails to correct the deficiencies or data errors by the date specified by CMS. • We are finalizing § 414.1400(f)(3) to state that, for purposes of paragraph (f), CMS may determine that submitted data is inaccurate, unusable, or otherwise compromised if it: Includes, without limitation, TIN/NPI mismatches, formatting issues, calculation errors, or data audit discrepancies; and affects more than 3 percent of the total number of MIPS eligible clinicians or group for which data was submitted by the third party intermediary. l. Public Reporting on Physician Compare This section contains our approach for public reporting on Physician Compare for year 3 of the Quality Payment Program (2019 data available for public reporting in late 2020) and future years, including MIPS, APMs, and other information as required by the MACRA and building on our previously finalized public reporting policies (see 82 FR 53819 through 53832). Physician Compare (https:// www.medicare.gov/physiciancompare) draws its operating authority from section 10331(a)(1) of the Affordable Care Act. Consistent with section 10331(a)(2) of the Affordable Care Act, Physician Compare initiated a phased approach to publicly reporting performance scores that provide comparable information on quality and patient experience measures. A complete history of public reporting on Physician Compare is detailed in the CY PO 00000 Frm 00076 Fmt 4701 Sfmt 4700 2016 PFS final rule (80 FR 71117 through 71122). More information about Physician Compare, including the history of public reporting and regular updates about what information is currently available, can also be accessed on the Physician Compare Initiative website at https://www.cms.gov/ medicare/quality-initiatives-patientassessment-instruments/physiciancompare-initiative/. As discussed in the CY 2018 Quality Payment Program final rule (82 FR 53820), Physician Compare has continued to pursue a phased approach to public reporting under the MACRA in accordance with section 1848(q)(9) of the Act. Generally, all data available for public reporting on Physician Compare must meet our established public reporting standards under § 414.1395(b). In addition, for each program year, CMS provides a 30-day preview period for any clinician or group with Quality Payment Program data before the data are publicly reported on Physician Compare under § 414.1395(d). All data available for public reporting—measure rates, scores, and attestations, objectives, etc.—are available for review and correction during the targeted review process. See the CY 2018 Quality Payment Program final rule for details on this process (82 FR 53820). Lastly, section 104(e) of the MACRA requires the Secretary to make publicly available, on an annual basis, in an easily understandable format, information for physicians and, as appropriate, other eligible clinicians related to items and services furnished to Medicare beneficiaries under Title XVIII of the Act. In accordance with section 104(e) of the MACRA, we finalized a policy in the CY 2016 PFS final rule (80 FR 71131) to add utilization data to the Physician Compare downloadable database. We believe section 10331 of the Affordable Care Act supports the overarching goals of the MACRA by providing the public with performance information that will help them make informed decisions about their health care, while encouraging clinicians to improve the quality of care they provide to their patients. In accordance with section 10331 of the Affordable Care Act, section 1848(q)(9) of the Act, and section 104(e) of the MACRA, we plan to continue to publicly report performance information on Physician Compare. As such, the following sections discuss the information previously finalized for inclusion on Physician Compare for all program years, as well as our finalized policies for public reporting on Physician Compare for year 3 of the Quality E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations Payment Program (2019 data available for public reporting in late 2020) and future years. We received several miscellaneous comments, but since these were not applicable to specific proposals made, these comments are outside the scope of this section and the proposed rule. amozie on DSK3GDR082PROD with RULES3 (1) Final Score, Performance Categories, and Aggregate Information In the CY 2018 Quality Payment Program final rule (82 FR 53823), we finalized a policy to publicly report on Physician Compare, either on profile pages or in the downloadable database, the final score for each MIPS eligible clinician and the performance of each MIPS eligible clinician for each performance category, and to periodically post aggregate information on the MIPS, including the range of final scores for all MIPS eligible clinicians and the range of performance of all the MIPS eligible clinicians for each performance category, as technically feasible, for all future years. We will use statistical testing and user testing, as well as consultation with the Physician Compare Technical Expert Panel convened by our contractor, to determine how and where these data are best reported on Physician Compare. A summary of the previously finalized policies related to each performance category of MIPS data, as well as finalized policies for year 3 and future years, follows. It is important to note just because performance information is available for public reporting, it does not mean all data under all performance categories will be included on either public-facing profile pages or the downloadable database. These data must meet the public reporting standards, first. And, second, we are careful to ensure that we do not include too much information on public-facing profile pages in an effort not to overwhelm website users. Although all information submitted under MIPS is technically available for public reporting, we will continue our phased approach to making this information public. (2) Quality In the CY 2018 Quality Payment Program final rule (82 FR 53824), we finalized a policy to make all measures under the MIPS quality performance category available for public reporting on Physician Compare, either on profile pages or in the downloadable database, as technically feasible. This includes all available measures across all collection types for both MIPS eligible clinicians and groups, for all future years. We will use statistical testing and website user VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 testing to determine how and where measures are reported on Physician Compare. We will not publicly report first year quality measures, meaning any measure in its first year of use in the quality performance category, under § 414.1395(c). We will also include the total number of patients reported on for each measure included in the downloadable database (82 FR 53824). We proposed to modify § 414.1395(b) to reference ‘‘collection types’’ instead of ‘‘submission mechanisms’’ to accurately update the terminology (83 FR 35987), consistent with the proposal to add this term and its definition under § 414.1305. We also proposed to revise § 414.1395(c) to indicate that we will not publicly report first year quality measures for the first 2 years a measure is in use in the quality performance category (83 FR 35987). We proposed this change to encourage clinicians and groups to report new measures, get feedback on those measures, and learn from the early years of reporting measures before measure are made public. We requested comment on these proposals. The following is a summary of the comments we received on these proposals and our responses. Comment: Most commenters supported not publicly reporting first year data on quality measures for the first 2 years to encourage adoption of new measures and allow clinicians and groups to get experience with and feedback on these measures before they are publicly reported. One commenter noted concern with delaying the public reporting of first year quality measures for the first 2 years they are in use, stating it would slow the progress toward full Quality Payment Program implementation and in fostering evaluation of more clinicians reporting a consistent set of measures. A few commenters suggested that 3 years is a more appropriate length of time for delaying publicly reporting first year measures, stating this timeframe would allow CMS to adequately evaluate meaningful trends over time and provide clinicians with an adequate period to fix data collection issues and give clinicians more time to respond to performance feedback. A few commenters requested that public reporting on Physician Compare be delayed until the transition years to full Quality Payment Program implementation end and there is more predictability, continuity, consistency, and decreased complexity in the program. In addition, several commenters submitted suggestions regarding transparency of publicly reported performance data. One PO 00000 Frm 00077 Fmt 4701 Sfmt 4700 59911 commenter requested that Physician Compare note for publicly reported measures if a change to clinical guidelines occurred during the performance year, so that the data provided is not misleading to the public. Response: We agree that not publicly reporting first year data on quality measures for the first 2 years they are in use is sufficient time to gain experience with them before they are considered for public reporting and believe 2 years also meets the goal of providing more timely and transparent information to the public on clinician performance for making their healthcare decisions. We believe that waiting 3 years to publicly report first year measures unnecessarily hinders the ability to provide the public with transparent performance information after clinicians have already received such feedback and also reduces the non-financial incentive for clinicians to improve their performance. Additionally, we do not believe that delaying the public reporting of first year quality measures for the first 2 years they are in use delays Quality Payment Program implementation or evaluation of more clinicians reporting a consistent set of measures, since, at this time, eligible clinicians and groups have the flexibility to select from a broad list of measures and do not all need to report the exact same measures. Regarding the comment suggesting public reporting be delayed until the Quality Payment Program is fully implemented, we note that we are required under section 1848(q)(9)(A) and (D) of the Act to publicly report certain MIPS eligible clinician and group performance information on Physician Compare. However, we do recognize that we are in early stages of MIPS, which is why we are continuing to publicly report this information under a phased approach. In response to the suggestion to indicate, on Physician Compare, when a measure specification has changed, we note that if there are significant changes to a clinical guideline during the performance year and the measure specifications do not reflect the current standard of care, the measure is suppressed from MIPS scoring. Refer to III.I.3.i.(1)(b)(vii) of this final rule for more information on the scoring policy. Only data that meet our established public reporting standards under § 414.1395(b) will be publically reported on Physician Compare. Regarding the comments supporting data transparency, we agree that for public reporting to be meaningful to all stakeholders, transparency is key. Each year we strive to actively share information, via the Physician Compare E:\FR\FM\23NOR3.SGM 23NOR3 59912 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations amozie on DSK3GDR082PROD with RULES3 initiative page and other channels, on our public reporting efforts as testing is completed and measures to be publicly reported are finalized. Last year in response to similar comments, we produced additional educational materials about the 5-star rating methodology and cut-offs, for example. We will continue our educational efforts as public reporting on Physician Compare evolves. We also reiterate our belief in the importance of clinicians reviewing their data for accuracy prior to it being publicly reported. All performance data publicly reported on Physician Compare will reflect the scores eligible clinicians and groups receive in their MIPS performance feedback, which are available for review and correction during the targeted review process. After consideration of the comments, we are finalizing our proposal to revise § 414.1395(c) to indicate that we will not publicly report first year quality measures for the first 2 years a measure is in use in the quality performance category. We did not receive any comments on changing ‘‘submission mechanism’’ to ‘‘collection type’’ for the purposes of public reporting, and as a result are finalizing our proposal to modify § 414.1395(b) to reference ‘‘collection types’’ instead of ‘‘submission mechanisms’’. (3) Cost In the CY 2018 Quality Payment Program final rule (82 FR 53825), we finalized a policy to include on Physician Compare a subset of cost measures that meet the public reporting standards at § 414.1395(b), either on profile pages or in the downloadable database, if technically feasible, for all future years. This includes all available cost measures, and applies to both MIPS eligible clinicians and groups. We will use statistical testing and website user testing to determine how and where measures are reported on Physician Compare. We previously finalized that we will not publicly report first year cost measures, meaning any measure in its first year of use in the cost performance category, under § 414.1395(c). Consistent with our proposal for first year quality measures, we proposed to revise § 414.1395(c) to indicate that we will not publicly report first year cost measures for the first 2 years a measure is in use in the cost performance category (83 FR 35987). We proposed this change to help clinicians and groups get feedback on these measures and learn from the early years of these new measures being calculated before measure are made public (83 FR 35987). VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 We requested comment on this proposal. The following is a summary of the comments we received on this proposal and our responses. Comment: Most commenters supported not publicly reporting first year data on cost measures for the first 2 years to encourage adoption of new measures and allow clinicians and groups to get experience with and feedback on these measures before they are publicly reported. One commenter expressed concern that delaying the public reporting of first year cost measures for the first 2 years they are in use, stating it would slow the progress toward full Quality Payment Program implementation and in fostering evaluation of more clinicians reporting a consistent set of measures. Another commenter recommended, separately from the other cost measures, that we consider extending the timeframe for which the new episode-based cost measures are publicly reported, so that there is time to gain experience with collecting and analyzing these measures. Response: We agree that not publicly reporting first-year data on cost measures for the first 2 years they are in use is sufficient time to gain experience with them, including for the new episode-based cost measures, before they are considered for public reporting and believe 2 years also meets the goal of providing more timely and transparent information to the public on clinician performance for making their healthcare decisions. We believe that waiting 3 years to publicly report first year measures hinders the ability to provide the public with transparent information after clinicians will have already received such feedback and also reduces the non-financial incentive for clinicians to improve their performance. Additionally, we do not believe that delaying the public reporting of first year quality measures for the first 2 years they are in use delays Quality Payment Program implementation and in fostering evaluation of more clinicians reporting a consistent set of measures, as the cost performance category’s full implementation is already delayed. We also do not believe there is a need or benefit to set a different timeframe for episode-based measures than there is for other cost measures that will also have 2 years of usage prior to being considered for public reporting. After consideration of the comments, we are finalizing our proposal to revise § 414.1395(c) to indicate that we will not publicly report first year cost PO 00000 Frm 00078 Fmt 4701 Sfmt 4700 measures for the first 2 years a measure is in use. (4) Improvement Activities In the CY 2018 Quality Payment Program final rule (82 FR 53826), we finalized a policy to include a subset of improvement activities information on Physician Compare, either on the profile pages or in the downloadable database, if technically feasible, for all future years. This includes all available activities reported via all available collection types, and applies to both MIPS eligible clinicians and groups. For those eligible clinicians and groups that successfully meet the improvement activities performance category requirements, this information will be posted on Physician Compare as an indicator. We also finalized for all future years to publicly report first year activities if all other public reporting criteria are satisfied. (5) Promoting Interoperability (PI) In the CY 2018 Quality Payment Program final rule (82 FR 53827), we finalized a policy to include an indicator on Physician Compare for any eligible clinician or group who successfully meets the Promoting Interoperability performance category, as technically feasible, for all future years. ‘‘Successful’’ performance is defined as obtaining the base score of 50 percent (82 FR 53826). We also finalized a policy to include on Physician Compare, either on the profile pages or in the downloadable database, as technically feasible, additional information, including, but not limited to, objectives, activities, or measures specified in the CY 2018 Quality Payment Program final rule (82 FR 53827; see 82 FR 53663 through 53688). This includes all available objectives, activities, or measures reported via all available collection types, and applies to both MIPS eligible clinicians and groups (82 FR 53827). We will use statistical testing and website user testing to determine how and where objectives, activities, and measures are reported on Physician Compare. We also finalized for all future years to publicly report first year Promoting Interoperability objectives, activities, and measures if all other public reporting criteria are satisfied. In addition, we finalized that we will indicate ‘‘high’’ performance, as technically feasible and appropriate, in year 2 of the Quality Payment Program (2018 data available for public reporting in late 2019). ‘‘High’’ performance is defined as obtaining a score of 100 percent (82 FR 53826 through 53827). E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations As the Quality Payment Program progresses into year 3, and consistent with our work to simplify the requirements under the Promoting Interoperability performance category of MIPS, we proposed not to include the indicator of ‘‘high’’ performance and to maintain only an indicator for ‘‘successful’’ performance in the Promoting Interoperability performance category beginning with year 2 of the Quality Payment Program (2018 data available for public reporting in late 2019) (83 FR 35988). Not including the ‘‘high’’ performance indicator while maintaining the ‘‘successful’’ performance indicator continues to provide useful information to patients and caregivers without burdening website users with the additional complexity of accurately differentiating between ‘‘successful’’ and ‘‘high’’ performance, as this proved difficult for users in testing. User testing to date shows that website users value this information overall, however, as they appreciate knowing clinicians and groups are effectively using EHR technology to improve care quality (83 FR 35988). We requested comment on our proposal not to include the indicator for ‘‘high’’ performance in the Promoting Interoperability performance category beginning with year 2 of the Quality Payment Program (2018 data available for public reporting in late 2019) (83 FR 35988). The following is a summary of the comments we received on our proposal and our responses. Comment: The majority of commenters supported the proposal to move to a designation of ‘‘successful’’ only and to remove the ‘‘high’’ designation in the Promoting Interoperability performance category, as it offers a clear indication that clinicians are effectively using EHRs and would make the user experience more straightforward than delineating between multiple indicators. One commenter opposed the proposal to only include a ‘‘successful’’ indicator, since in future years it would be difficult to be ‘‘successful,’’ as defined, when the base scores, performance scores, and bonus scores are changed or removed. Another commenter requested clarification on how ‘‘successful’’ would be defined when the Promoting Interoperability performance category no longer includes a base score. Response: We agree that moving from having both a ‘‘successful’’ and ‘‘high’’ indicator of an eligible clinician or group’s Promoting Interoperability performance to having a single indicator of ‘‘successful’’ not only shows that VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 clinicians are effectively using EHRs, but also is easier for patients to understand. Additionally, it is more technically feasible to designate a single ‘‘successful’’ indicator than both a ‘‘successful’’ and ‘‘high’’ indicator as the Promoting Interoperability performance category scoring methodology evolves and as we evaluate operational facets of the data. We wish to also clarify that having only a ‘‘successful’’ indicator will apply to individuals and groups who have a Promoting Interoperability performance category score above zero. After consideration of the public comments received, we are finalizing our proposal to not include the indicator of ‘‘high’’ performance and to maintain only an indicator for ‘‘successful’’ performance in the Promoting Interoperability performance category beginning with year 2 of the Quality Payment Program. We note that in the CY 2017 Quality Payment Program final rule (81 FR 77397), we finalized a policy to include, as technically feasible, additional indicators, including but not limited to indicators such as, identifying if the eligible clinician or group scores high performance in patient access, care coordination and patient engagement, or health information exchange. We have since determined that it is not technically feasible to include an indicator of ‘‘high’’ performance that meets our public reporting standards as defined at § 414.1395(b) for year 1 of the Quality Payment Program. The reason we are not reporting this indicator, is because based upon conducting analysis against our public reporting standards, the scoring variability in the Promoting Interoperability performance category of the Quality Payment Program (year 1 to year 3) creates challenges that we are still uncovering for making the data useful to Physician Compare’s primary patient and caregiver audience. Additionally, in reviewing the year 1 data (which was not available at the time the CY 2019 proposed rule was released) we have learned through user testing that patients and caregivers find clinician and group usage of EHR technology to generally be a meaningful indicator of quality, regardless of whether ‘‘successful’’ or ‘‘high’’ was noted. That is, including the word ‘‘high’’ did not result in patients and caregivers believing the clinician or group to be of higher quality than those that had the word ‘‘successful’’ next to their Promoting Interoperability performance category indicator. Therefore, the high performing indicator will not be reported in year 1, 2, 3 or PO 00000 Frm 00079 Fmt 4701 Sfmt 4700 59913 future years of the Quality Payment Program on Physician Compare. As noted above, we previously defined ‘‘successful’’ performance as obtaining the base score of 50 percent (82 FR 53826). As discussed in section III.I.3.h.(5) of this final rule, the Promoting Interoperability performance category will no longer have a base score beginning with year 3. To account for this change, we are finalizing a modified definition of ‘‘successful’’ performance to mean a Promoting Interoperability performance category score above zero beginning with year 3. We will include the modified indicator (above zero) for years 1, 2, and 3 to avoid confusion and preserve year-toyear comparability, and the previously finalized indicator (base score) for years 1 and 2 for transparency and consistency with our previously finalized policy, as technically feasible. We also solicited comment on the type of EHR utilization performance information stakeholders would like CMS to consider adding to Physician Compare. This information may be considered for possible future inclusion on the website. We did not receive any comments. (6) Achievable Benchmark of Care (ABCTM) Benchmarks are important to ensuring that the quality data published on Physician Compare are accurately understood. A benchmark allows website users to more easily evaluate the information published by providing a point of comparison between groups and between clinicians. In the CY 2018 Quality Payment Program final rule (82 FR 53829), we finalized a policy to use the Achievable Benchmark of Care (ABCTM) methodology to determine a benchmark for the quality, cost, improvement activities, and Promoting Interoperability data, as feasible and appropriate, by measure and collection type for each year of the Quality Payment Program based on the most recently available data each year. We also finalized a policy to use this benchmark as the basis of a 5-star rating for each available measure, as feasible and appropriate. For a detailed discussion of the ABCTM methodology, and more information about how this benchmark together with the equal ranges method is currently used to determine the 5-star rating system for Physician Compare, see the CY 2018 Quality Payment Program final rule (82 FR 53827 through 53829). Additional information, including the Benchmark and Star Rating Fact Sheet, is available on the Physician Compare Initiative website at https://www.cms.gov/ E:\FR\FM\23NOR3.SGM 23NOR3 59914 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations amozie on DSK3GDR082PROD with RULES3 Medicare/Quality-Initiatives-PatientAssessment-Instruments/physiciancompare-initiative/. We appreciate comments received for this section, but since no proposals were made, these comments are outside the scope of this section and the proposed rule. (a) Historical Data-Based Benchmarks Benchmarks, and the resulting star rating, are valuable tools for patients and caregivers to use to best understand the performance information included on Physician Compare. Benchmarks can also help the clinicians and groups reporting performance information understand their performance relative to their peers, and therefore, help foster continuous quality improvement. In the initial years of the Quality Payment Program, we anticipated year-to-year changes in the measures available. As noted, we previously finalized a policy to determine the benchmark using the most recently available data (82 FR 53829). This ensured that a benchmark could be calculated despite potential year-to-year measure changes, but it also meant that the benchmark was not known to clinicians and groups prior to the performance period. By year 3 of the Quality Payment Program (2019 data available for public reporting in late 2020), we expect enough year-to-year stability in the measures available for reporting across all MIPS performance categories to use historical data to produce a reliable and statistically sound benchmark for most measures, by measure and collection type (83 FR 35988). Therefore, we proposed to modify our existing policy to use the ABCTM methodology to determine benchmarks for the quality, cost, improvement activities, and Promoting Interoperability performance categories based on historical data, as feasible and appropriate, by measure and collection type beginning with year 3 of the Quality Payment Program (2019 data available for public reporting in late 2020) (83 FR 35988). Specifically, benchmarks would be based on performance data from a baseline period or, if such data is not available, performance data from the performance period. The baseline period would be the 12-month calendar year that is 2 years prior to the applicable performance period. The benchmarks would be published prior to the start of the performance period, as technically feasible. For example, for the CY 2019 performance period, the benchmark developed using the ABCTM methodology would be calculated using CY 2017 performance period data and would be published by the start of CY VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 2019, as feasible and appropriate. If historical data is not available for a particular measure, we would indicate that and calculate the benchmark using performance data from the performance period. In this example, we would use CY 2019 performance period data to calculate the benchmark for CY 2019 performance period measures, as needed. This approach of utilizing historical data would be consistent with how the MIPS benchmarks are calculated for purposes of scoring the quality performance category. But, most importantly, this approach would provide eligible clinicians and groups with valuable information about the benchmark to meet to receive a 5-star rating on Physician Compare before data collection starts for the performance period (83 FR 35988). We requested comment on this proposal. The following is a summary of the comments we received regarding our proposal to modify our existing policy to use the ABCTM methodology to determine benchmarks for the quality, cost, improvement activities, and Promoting Interoperability performance categories based on historical data, as feasible and appropriate, by measure and collection type beginning with year 3 of the Quality Payment Program (2019 data available for public reporting in late 2020) and our responses. Comment: Two commenters supported using benchmarks based on performance from a prior period so that clinicians are able to understand how their measure scores will translate into a 5-star rating. One commenter cautioned that historical benchmarks may penalize those clinicians who successfully managed costs at the onset of the benchmark while inadvertently incentivizing high spenders. Another commenter questioned whether there was enough stability year-to-year in MIPS to create valid and reliable benchmarks. Another commenter noted concern that historical benchmarks would be based on data from a small number of clinicians from various legacy programs such as the Physician Quality Reporting System (PQRS). Another commenter cautioned that CMS needs to consider certain clinicians’ ability to affect quality and cost when treating patients. One commenter recommended we postpone using benchmarks for measures with no historical data, for example, a new MIPS measure with no performance data from a prior performance year. Response: Regarding the concern that historical benchmarks would be based on data from a small number of clinicians from various legacy programs such as the PQRS, we wish to clarify PO 00000 Frm 00080 Fmt 4701 Sfmt 4700 that only historical MIPS data will be used to create benchmarks; for example, year 3, which is 2019 data available for public reporting in late 2020, would use year 1 (CY 2017) MIPS data. Additionally, since these benchmarks will be based on the MIPS performance information that eligible clinicians choose to report, we assume that these measures, upon which the benchmarks will be based, reflect the areas in which eligible clinicians and groups believe they can most affect quality of care furnished. Since we are finalizing that we will not publicly report first year measures for the first 2 years they are in the program, new measures, which have no prior MIPS performance data, would not be available for public reporting until the third year they are in use, at which point there should be historical data upon which to set a historical benchmark if eligible clinicians and groups reported them. If, however, a measure does not meet our public reporting standards, for example due to lack of performance data available or insufficient sample size, then the measure would not be available for public reporting, and would not need a benchmark. Regarding the concern about stability of data, we do believe that if a measure is in use for multiple years of MIPS that the performance should stabilize. We do not expect that clinicians and groups who manage costs effectively in 2017 should suffer a penalty by comparing their 2019 data to 2017 benchmarks. We appreciate the comment about high spenders and will plan to analyze impact. That said, we appreciate the concerns raised and will continuously evaluate the data against our public reporting standards for yearto-year stability. We will also monitor whether the historical benchmarking approach inadvertently creates negative incentives, though early testing has not shown this to be the case. Regarding the suggestion to postpone using benchmarks for measures without historical data, we disagree and believe it is important for website users to understand clinician performance in a meaningful way. Our testing and experience to date has shown that the next best way to create benchmarks for information reported on Physician Compare, in the absence of historical data, is by using information from the most recent performance period. After consideration of the comments, we are finalizing our proposal to modify our existing policy to use the ABCTM methodology to determine benchmarks for the quality, cost, improvement activities, and Promoting Interoperability performance categories E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations amozie on DSK3GDR082PROD with RULES3 based on historical data, as feasible and appropriate, by measure and collection type beginning with year 3 of the Quality Payment Program (2019 data available for public reporting in late 2020). Specifically, benchmarks will be based on performance data from a baseline period or, if such data is not available, performance data from the performance period. The baseline period will be the 12-month calendar year that is 2 years prior to the applicable performance period. The benchmarks will be published prior to the start of the performance period, as technically feasible. (b) QCDR Measure Benchmarks Currently, only MIPS measures are star rated on Physician Compare. QCDR measures, as that term is used in § 414.1400(e), are publicly reported as percent performance rates. As more QCDR measure data is available for public reporting, and appreciating the value of star rating the measures presented to website users, we believe star rating the QCDR measures will greatly benefit patients and caregivers as they work to make informed health care decisions. Particularly in the quality performance category, we believe that reporting all measure data in the same way will ease the burden of interpretation placed on site users and make the data more useful to them. Therefore, we proposed (83 FR 35988 through 35989) to further modify our existing policy to extend the use of the ABCTM methodology and equal ranges method to determine, by measure and collection type, a benchmark and 5-star rating for QCDR measures, as that term is used in proposed § 414.1400(b)(3), as feasible and appropriate, using current performance period data in year 2 of the Quality Payment Program (2018 data available for public reporting in late 2019), and using historical benchmark data when possible as proposed above, beginning with year 3 of the Quality Payment Program (2019 data available for public reporting in late 2020). We requested comment on this proposal. The following is a summary of the comments we received to further modify our existing policy to extend the use of the ABCTM methodology and equal ranges method to determine, by measure and collection type, a benchmark and 5star rating for QCDR measures and our responses. Comment: One commenter supported using the ABCTM methodology to create a benchmark for MIPS and QCDR measures, as well as creating a 5-star rating for QCDR measures, beginning with year 3 of the Quality Payment Program. Several commenters expressed VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 concern about QCDR benchmarks, noting that measure scores could be misinterpreted on Physician Compare, particularly if the ABCTM methodology is used, since it may differ from the QCDR’s own rating methodology and further confuse patients. One commenter also noted that use of the ABCTM methodology for QCDR measures would cause clinician confusion and potentially misrepresent clinicians in the public domain if it results in benchmarks that are also different from the ones used in the MIPS scoring methodology. Another commenter noted the sample size for some QCDR measures will be too small for public reporting and encouraged CMS to work with QCDR measure owners in establishing benchmarks for QCDR measures. Response: We reiterate our belief that star rating the QCDR measures will greatly benefit patients and caregivers. Because the QCDRs do not uniformly measure performance and each uses their own methodology, as commenters pointed out, in our experience it makes it more difficult for patients to use this information to make informed healthcare decisions. Regarding the concern about differences in MIPS scoring benchmarks and public reporting benchmarks, we note that we will continue to evaluate approaches to alignment, but reiterate that it is not always necessary or ideal to use the same methodology for scoring and public reporting given the unique goals of each. QCDR measures will undergo the same statistical testing as other measures do to ensure they meet our public reporting standards before they are publicly reported, and this testing does account for sample size concerns. After consideration of the comments, we are finalizing our proposal to further modify our existing policy to extend the use of the ABCTM methodology and equal ranges method to determine, by measure and collection type, a benchmark and 5-star rating for QCDR measures, as that term is used in proposed § 414.1400(b)(3), as feasible and appropriate. This benchmark will use current performance period data in year 2 of the Quality Payment Program (2018 data available for public reporting in late 2019), and using historical benchmark data when possible as proposed above, beginning with year 3 of the Quality Payment Program (2019 data available for public reporting in late 2020). (7) Voluntary Reporting In the CY 2018 Quality Payment Program final rule (82 FR 53830), we finalized a policy to make available for PO 00000 Frm 00081 Fmt 4701 Sfmt 4700 59915 public reporting all data submitted voluntarily across all MIPS performance categories, regardless of collection type, by eligible clinicians and groups that are not subject to the MIPS payment adjustments, as technically feasible, for all future years. If an eligible clinician or group that is not subject to the MIPS payment adjustment chooses to submit data on quality, cost (if applicable), improvement activities, or Promoting Interoperability, these data are available for public reporting. We also finalized that during the 30-day preview period, these eligible clinicians and groups may opt out of having their data publicly reported on Physician Compare (82 FR 53830). If these eligible clinicians and groups do not opt out during the 30-day preview period, their data will be available for inclusion on Physician Compare if the data meet all public reporting standards at § 414.1395(b). (8) APM Data In the CY 2018 Quality Payment Program final rule (82 FR 53830), we finalized a policy to publicly report the names of eligible clinicians in Advanced APMs and the names and performance of Advanced APMs and APMs that are not considered Advanced APMs related to the Quality Payment Program, such as Track 1 Shared Savings Program Accountable Care Organizations (ACOs), as technically feasible, for all future years. We also finalized a policy to link clinicians and groups and the APMs they participate in on Physician Compare, as technically feasible. 4. Overview of the APM Incentive a. Overview Section 1833(z) of the Act requires that an incentive payment be made (or, in years after 2025, a different PFS update) to QPs for achieving threshold levels of participation in Advanced APMs. In the CY 2017 Quality Payment Program final rule (81 FR 77399 through 77491), we finalized the following policies: • Beginning in payment year 2019, if an eligible clinician participated sufficiently in an Advanced APM during the QP Performance Period, that eligible clinician may become a QP for the year. Eligible clinicians who are QPs are excluded from the MIPS reporting requirements for the performance year and payment adjustment for the payment year. • For payment years from 2019 through 2024, QPs receive a lump sum incentive payment equal to 5 percent of their prior year’s estimated aggregate payments for Part B covered E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59916 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations professional services. Beginning in payment year 2026, QPs receive a higher update under the PFS for the year than non-QPs. • For payment years 2019 and 2020, eligible clinicians may become QPs only through participation in Advanced APMs. • For payment years 2021 and later, eligible clinicians may become QPs through a combination of participation in Advanced APMs and Other Payer Advanced APMs (which we refer to as the All-Payer Combination Option). In the CY 2018 Quality Payment Program final rule (82 FR 53832 through 53895), we finalized clarifications, modifications, and additional details pertaining to Advanced APMs, Qualifying APM Participant (QP) and Partial QP determinations, Other Payer Advanced APMs, Determination of Other Payer Advanced APMs, Calculation of All-Payer Combination Option Threshold Scores and QP Determinations, and Physician-Focused Payment Models (PFPMs). In the CY 2019 PFS proposed rule (83 FR 35989 through 36006), we proposed clarifications and modifications to policies that we previously finalized pertaining to Advanced APMs, QP and Partial QP determinations, Other Payer Advanced APMs, Determination of Other Payer Advanced APMs, and the Calculation of All-Payer Combination Option Threshold Scores and QP Determinations. In this CY 2019 PFS final rule, we respond to public comments on those proposals and announce our final policies. The following is a summary of the general public comments received on Advanced APMs and our responses: Comment: Many commenters encouraged us to accelerate our efforts to develop more Advanced APM opportunities for clinicians. These commenters noted that Advanced APMs have great potential to incentivize highquality and coordinated care while driving down overall costs, and encouraged us to continue developing Advanced APMs to offer clinicians more opportunity to participate in valuebased payment and care delivery. Some commenters noted concern that no progress has been made in creating more opportunities for specialists and nonphysician professionals to participate in Advanced APMs. The commenters encouraged CMS to develop Advanced APMs that provide opportunities for specialists and non-physician professionals, and to create additional pathways for specialists and nonphysician professionals to meaningfully participate in existing Advanced APMs. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 Response: We agree that APMs represent an important step forward in our efforts to move our healthcare system from volume-based to valuebased care. We note that in 2018 a number of additional Advanced APM opportunities were made available, including the introduction of the Medicare ACO Track 1+ Model, and the introduction of new participants into some existing Advanced APMs, such as the Next Generation ACO Model and Comprehensive Primary Care Plus (CPC+) Model. In 2019, there will be even more available Advanced APM opportunities including the Bundled Payments for Care Improvement Advanced Model, which began in October 2018, and the Maryland Total Cost of Care (which includes the Care Redesign Program and the Maryland Primary Care Program). Additionally, we are in the process of developing several new APMs and Advanced APMs, and continue to work with stakeholders on new model concepts. Comment: Some commenters suggested CMS establish a clear pathway for clinicians to transition from MIPS to MIPS APMs and then to Advanced APMs. The commenters noted that MIPS APMs represent a stepping stone between MIPS and Advanced APMs providing clinicians a necessary glide path into risk-based contracts. Response: The Quality Payment Program represents a significant opportunity to collaborate with the clinical community to advance policy that pays for what works—both for clinicians and patients—to create a simpler, sustainable Medicare program. We believe that the Quality Payment Program provides new opportunities to improve care delivery by supporting and rewarding clinicians as they find new ways to engage patients, families, and caregivers and to improve care coordination and population health management. In addition, we believe that by developing a program that is flexible instead of one-size-fits-all, clinicians will be able to choose to participate in a way that is best for them, their practice, and their patients. For clinicians interested in APMs, including MIPS APMs and Advanced APMs, we believe that by setting ambitious yet achievable goals, eligible clinicians will move with greater certainty toward these new approaches that incentivize the delivery of highvalue care. We will continue to reach out to the clinician community and others to partner in the development of ongoing education, support, and technical assistance materials and activities to PO 00000 Frm 00082 Fmt 4701 Sfmt 4700 help clinicians understand Quality Payment Program requirements, how to use available tools to enhance their practices, improve quality, reduce cost, and progress to participation in APMs and Advanced APMs if that is the best choice for their practice. Comment: Many commenters requested that we implement and test new models recommended by the Physician-Focused Payment Model Technical Advisory Committee (PTAC). The commenters noted that the stakeholder community is also well aware the Department has not selected any PTAC recommended models for testing. Specifically, the commenters noted that the PTAC had received 27 proposals for new physician-focused payment models, 15 of which have been reviewed by the PTAC with comments and recommendations sent to the Secretary. Of those, the commenters stated that 10 proposals were recommended favorably with six recommended for limited scale testing and four recommended for implementation, but the agency has taken no action to test or implement any of the recommended models. Some commenters suggested we provide more direct, regular feedback to the PTAC and stakeholders to ensure they can address concerns and shortcomings earlier in the development process, so that the PTAC comment and recommendation process can yield physician-led APMs that will be tested and implemented. The commenters also requested that we provide technical assistance to stakeholders working to develop proposals for the PTAC, and specifically that we make claims data available to allow for more detailed financial modeling to be part of the development process. Many commenters requested that we establish a clear process and timeline for responding to PTAC proposals in the future. The commenters suggested that a 60-day window from the date that the Secretary receives a recommendation from the PTAC would be appropriate. Response: We believe that PTAC can help us make the shift from a healthcare system that pays for volume to one that pays for value. The commitment to health care payment innovation by the PTAC and the broader stakeholder community is evident in the number and types of specialties represented in the proposals being submitted to PTAC. CMS’ Center for Medicare and Medicaid Innovation (CMS Innovation Center) staff have met with stakeholders about proposed models, including some stakeholders that have submitted proposed physician-focused payment models to the PTAC. E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations We note that while it seems unlikely that all of the features of any PTACreviewed proposed model will be tested exactly as presented in the proposal, certain features of proposed models may be incorporated into new or existing models. As the CMS Innovation Center launches new value-based payment and service delivery models, the PTAC’s critical review of proposals will be a valuable resource. Additionally, the CMS Innovation Center will further engage with stakeholders that have submitted proposals related to new or existing models to leverage their experiences in the field. While we will not provide technical assistance to individual stakeholders before they submit proposals, we encourage potential submitters to review the detailed responses from the Secretary to past comments and recommenations from the PTAC to guide development of their proposals. We also encourage stakeholders designing proposals to review the data resources available on the Office of the Assistance Secretary for Planning and Evaluation (ASPE) website at https:// aspe.hhs.gov/resources-publiccomment-physician-focused-paymentmodel-technical-advisory-committee. Lastly, available from the CMS Innovation Center website is a toolkit for Alternative Payment Model Design (APM Toolkit) to serve as a resource for any entities or individuals interested in developing ideas for APMs (https:// www.cms.gov/Medicare/QualityPayment-Program/Resource-Library/ Alternative-Payment-Model-APMDesign-Toolkit.pdf provides a detailed and comprehensive set of resources to help design an APM). We note that PTAC meets on a periodic basis to review proposals for physician-focused payment models submitted by individuals and stakeholder entities. The PTAC prepares comments and recommendations on proposals that are received, determining whether such models meet the criteria established by the Secretary for physician-focused payment models in the CY 2017 Quality Payment Program final rule with comment period (81 FR 77008, 77496–77499) and codified at § 414.1465. The PTAC’s comments and recommendations generally must be discussed during their public meetings and must be submitted to the Secretary. Subsequently, the Secretary reviews the comments and recommendations submitted by PTAC and posts a detailed response to these recommendations on the CMS Innovation Center website at https://innovation.cms.gov/initiatives/ pfpms/. Given this standard timeline, we do not believe it would be realistic VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 to set a strict 60-day timeframe for responding to physician-focused payment models recommended by the PTAC. As discussed in the CY 2018 Quality Payment Program final rule, the variation in the number and nature of proposals makes it difficult to establish such a deadline. However, HHS will continue to make every effort to respond expeditiously to the PTAC’s comments and recommendations. b. Terms and Definitions In the CY 2019 PFS proposed rule, we explained that as we continue to develop the Quality Payment Program, we have identified the need to propose changes to some of the previously finalized definitions. A complete list of the original definitions is available in the CY 2017 Quality Payment Program final rule (81 FR 77537 through 77540). In the CY 2018 Quality Payment Program final rule, to consolidate our regulations and avoid unnecessarily defining a term, we finalized removal of the defined term for ‘‘Advanced APM Entity’’ in § 414.1305 and replaced instances of that term throughout the regulation with ‘‘APM Entity.’’ Similarly, we finalized replacing ‘‘Advanced APM Entity group’’ with ‘‘APM Entity group’’ where it appears throughout our regulations (82 FR 53833). We noted that these changes were technical and had no substantive effect on our policies. In the CY 2019 PFS proposed rule, to further consolidate our regulations and to clarify any potential ambiguity, we proposed to revise the definition of Qualifying APM Participant (QP) at § 414.1305 to provide that a QP is an eligible clinician determined by CMS to have met or exceeded the relevant QP payment amount or QP patient count threshold for the year based on participation in or with an APM Entity that is participating in an Advanced APM. The current definition of QP is based on an eligible clinician’s participation in an Advanced APM Entity, which no longer is a defined term. Simply replacing the term ‘‘Advanced APM Entity’’ with the term ‘‘APM Entity,’’ as we had in the CY 2018 Quality Payment Program final rule, does not fully convey the definition of QP because, as noted at the time, an APM Entity can participate in an APM that is, or is not, an Advanced APM; and QP status is attainable only through participation in an Advanced APM (82 FR 53833). Again we note that this proposed change is technical and will not have a substantive effect on our policies. We solicited comments on this proposal. PO 00000 Frm 00083 Fmt 4701 Sfmt 4700 59917 We did not receive any comments in response to this proposal. We are finalizing our proposal to revise the definition of Qualifying APM Participant (QP) at § 414.1305 to provide that a QP is an eligible clinician determined by CMS to have met or exceeded the relevant QP payment amount or QP patient count threshold for the year based on participation in or with an APM Entity that is participating in an Advanced APM. c. Advanced APMs (1) Overview In the CY 2017 Quality Payment Program final rule (81 FR 77408), we finalized the criteria that define an Advanced APM based on the requirements set forth in sections 1833(z)(3)(C) and (D) of the Act. An Advanced APM is an APM that: • Requires its participants to use certified EHR technology (CEHRT) (81 FR 77409 through 77414); • Provides for payment for covered professional services based on quality measures comparable to measures under the quality performance category under MIPS (81 FR 77414 through 77418); and • Either requires its participating APM Entities to bear financial risk for monetary losses that are in excess of a nominal amount, or is a Medical Home Model expanded under section 1115A(c) of the Act (81 FR 77418 through 77431). We refer to this criterion as the financial risk criterion. (2) Summary of Proposals In the CY 2019 PFS proposed rule (83 FR 35989–35992), we included the following proposals, each of which is discussed in further detail below: Use of CEHRT • We proposed to revise § 414.1415(a)(i) to specify that an Advanced APM must require at least 75 percent of eligible clinicians in each APM Entity use CEHRT as defined at § 414.1305 to document and communicate clinical care with patients and other health care professionals. MIPS-Comparable Quality Measures • We proposed to revise § 414.1415(b)(2) to clarify, effective January 1, 2020, that at least one of the quality measures upon which an Advanced APM bases the payment must either be finalized on the MIPS final list of measures, as described in § 414.1330; endorsed by a consensus-based entity; or determined by CMS to be evidencedbased, reliable, and valid. • We also proposed to revise § 414.1415(b)(3), effective January 1, 2020, to provide that at least one E:\FR\FM\23NOR3.SGM 23NOR3 59918 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations In the CY 2019 PFS proposed rule, we proposed that, beginning for CY 2019, to be an Advanced APM, the APM must require at least 75 percent of eligible clinicians in each APM Entity use CEHRT as defined at § 414.1305 to document and communicate clinical care with patients and other health care professionals. According to data collected by the Office of the National Coordinator for Health Information Technology (ONC), over 3 in 4 office-based physicians adopted a certified EHR in CY 2015,32 and approximately 9 in 10 clinicians have 2015 Edition certified technology available from their EHR developer.33 Additionally, in response to the CY 2017 Quality Payment Program proposed rule, commenters encouraged us to raise the CEHRT use criterion to 75 percent (see 81 FR 77411). We believe that this proposed change aligns with the increased adoption of CEHRT among providers and suppliers that is already happening, and will encourage further CEHRT adoption. We further believe that most existing Advanced APMs already include provisions that would require participants to adhere to the level of CEHRT use specified in our regulations, and therefore this increase will not negatively impact the Advanced APM status of those APMs. We solicited comment on this proposal. The following is a summary of the public comments received on this proposal and our responses: Comment: Many commenters supported our proposal to increase the Advanced APM minimum CEHRT use threshold from 50 percent to 75 percent in 2019. Some commenters noted that the use of CEHRT is a fundamental component of any Advanced APM and that such APMs are more likely to be successful if physicians are able to receive information on their patients in a seamless manner, as well as document and communicate clinical care with patients and other health care professionals. Response: We appreciate the commenters’ support of our proposal to increase the Advanced APM minimum CEHRT use threshold from 50 percent to 75 percent beginning in 2019. Comment: Many commenters requested that CMS not finalize the proposed increase in the Advanced APM minimum CEHRT use threshold from 50 percent to 75 percent beginning in 2019. Some commenters stated that such an increase could be too burdensome for some APM participants, especially in light of the regulatory requirement to upgrade from 2014 Edition CEHRT to 2015 Edition CEHRT in CY 2019. Other commenters noted the proposed increase could create a barrier to entry into Advanced APMs or create additional obstacles in designing APMs targeted for small or rural practices. Response: We do not believe that the proposed increase in the Advanced APM minimum CEHRT use threshold from 50 to 75 percent will be 32 Office of the National Coordinator for Health Information Technology. ’Office-based Physician Electronic Health Record Adoption,’ Health IT Quick-Stat #50. dashboard.healthit.gov/quickstats/ pages/physician-ehr-adoption-trends.php. December 2016. 33 Office of the National Coordinator for Health Information Technology. ’2015 Edition Market Readiness for Hospitals and Clinicians,’ Health IT Quick-Stat #55. dashboard.healthit.gov/quickstats/ pages/2015-edition-market-readiness-hospitalsclinicians.php. October 2018. outcome measure, for which measure results are included as a factor when determining payment to participants under the terms of the APM must either be finalized on the MIPS final list of measures as described in § 414.1330, endorsed by a consensus-based entity; or determined by CMS to be evidencebased, reliable, and valid. Bearing Financial Risk for Monetary Losses • We proposed to revise § 414.1415(c)(3)(i)(A) to maintain the generally applicable revenue-based nominal amount standard at 8 percent of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities for QP Performance Periods 2021 through 2024. (3) Use of CEHRT (a) Overview In the CY 2017 Quality Payment Program final rule, we finalized that an Advanced APM must require at least 50 percent of eligible clinicians in each APM Entity to use CEHRT as defined at § 414.1305 to document and communicate clinical care with patients and other health care professionals. Further, we proposed but did not finalize an increase to the requirement wherein Advanced APMs must require 75 percent CEHRT use in the subsequent year. Instead we maintained the 50 percent CEHRT use requirement for the second performance year and beyond and indicated that we would consider making any potential changes through future rulemaking (81 FR 77412). amozie on DSK3GDR082PROD with RULES3 (b) Increasing the CEHRT Use Criterion for Advanced APMs VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00084 Fmt 4701 Sfmt 4700 burdensome for APM participants. As noted above, approximately 9 in 10 clinicians have 2015 Edition certified technology available from their most recently reported EHR developer, and we believe it is appropriate to require the use of 2015 Edition CEHRT beginning in CY 2019. Also, in the CY 2017 Quality Payment Program final rule, we acknowledged that eligible clinicians would be expected to upgrade from technology certified to the 2014 Edition to technology certified to the 2015 Edition for use in 2018, and that some eligible clinicians who had not yet adopted CEHRT may wish to delay acquiring CEHRT products until a 2015 Edition certified product is available. We also note that the requirement to use 2015 Edition CEHRT was delayed in the CY 2018 Quality Payment Program final rule (82 FR 53671–53672), to provide eligible clinicians an additional year to upgrade from technology certified to the 2014 Edition to technology certified to the 2015 Edition for use in 2019. Further, we note that most current Advanced APMs already include provisions that would require participants to adhere to this new level of CEHRT use specified in our regulations, and therefore this increase will not negatively impact the Advanced APM status of those APMs. Moving forward, though, we will consider the applicability of the CEHRT requirement for any potential models designed specifically for small or rural practices. Comment: Many commenters requested that we consider delaying our proposal to increase the Advanced APM minimum CEHRT use threshold from 50 percent to 75 percent until CY 2020. Commenters stated there already is a regulatory requirement to upgrade to 2015 edition CEHRT in CY 2019 and that clinicians participating in Advanced APMs should not be subject to additional health information technology requirements in a single year. Commenters also noted that maintaining the current Advanced APM minimum CEHRT use threshold for an additional year will allow time for organizations and clinicians to implement the upgrade to 2015 edition CEHRT and not discourage smaller practices that are in the process of upgrading their systems from participating in Advanced APMs. Response: We appreciate commenters’ concerns, but as noted previously in this final rule, the requirement to use 2015 Edition CEHRT was delayed in the CY 2018 Quality Payment Program final rule (82 FR 53671 through 53672), to provide eligible clinicians an additional year to upgrade from technology E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations certified to the 2014 Edition to technology certified to the 2015 Edition for use in 2019. We believe organizations and clinicians had sufficient time to implement upgrades and that it is appropriate to require the use of 2015 Edition CEHRT beginning in CY 2019. Thus, we believe a delay in implementation of the increase in the Advanced APM minimum CEHRT use threshold increase is unnecessary. Comment: Many commenters requested that CMS phase in the increase in the Advanced APM minimum CEHRT use threshold over time, or develop a glide path more reflective of the multi-year contracting cycles of APMs given that current contracts with Advanced APMs, were signed with the current Advanced APM minimum CEHRT use threshold in place. Some commenters also suggested that CMS could retain the current 50 percent Advanced APM minimum CEHRT use threshold, but allow APM Entities to attest that an additional percentage of eligible clinicians are either using CEHRT or other health information technology that augments or is an extension of CEHRT to achieve the specific goals of the APM. Response: We reiterate that in the CY 2017 Quality Payment Program final rule, we stated that setting the threshold at 50 percent of eligible clinicians would allow APMs sufficient room to meet this requirement even if the APM includes some participants who do not have internet access, lack face-to-face interactions with patients, or are hospital-based. At that time, we recognized commenters’ concerns that raising the threshold to 75 percent in 2018 risked creating an overly rigorous standard for Advanced APMs and that it would be prudent to wait until we have more information on how the threshold would impact specific APMs, such as specialty APMs, before increasing the threshold. As noted previously in this final rule, we now understand that certified EHR adoption has been more widespread, and therefore do not believe that it is necessary to phase in the increase in the Advanced APM minimum CEHRT use threshold over time any more so than we already have by maintaining the threshold at 50 percent for the 2017 and 2018 QP performance periods. We also note that most current Advanced APMs already include provisions that require participants to adhere to this new level of CEHRT use specified in our regulations, and therefore this increase will not negatively impact the Advanced APM status of those APMs. Comment: One commenter suggested that CMS provide flexibility for APM VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 Entities participating in Advanced APMs by allowing them to include eligible clinicians in the 75 percent threshold calculation who are actively working with their EMR vendors to transition to the 2015 Edition CEHRT. The commenter noted that there may be instances where EMR vendors are finalizing their certification process during the 2019 performance year, and that may prevent an APM Entity from fully complying with the 75 percent threshold. Response: We reiterate that the Advanced APM CEHRT use criterion applies to APMs and the requirements they impose on participating APM Entities, not to the individual APM Entities participating in APMs. This means that once an APM has been determined to be an Advanced APM (by requiring the specified percentage of eligible clinicians in each of its participating APM Entities to use CEHRT), the methods used in the Advanced APM to ascertain whether the required percentage of CEHRT use is met may be unique to each APM and may not involve a threshold calculation. We acknowledge there may be instances where EMR vendors are finalizing their certification process, but as noted previously, the requirement to use 2015 Edition CEHRT was delayed to provide eligible clinicians an additional year to upgrade from technology certified to the 2014 Edition to technology certified to the 2015 Edition for use in 2019. Therefore, we believe it is appropriate to require the use of 2015 Edition CEHRT beginning in CY 2019. Comment: Many commenters noted that the proposed increase in the Advanced APM minimum CEHRT use threshold could limit the ability of nonphysician professionals, such as physical therapists, occupational therapists, audiologists, and speechlanguage pathologists, to meaningfully participate in APMs. The commenters noted that current CEHRT requirements are designed for prescribing professionals and do not capture tasks performed by non-physician professionals using different types of EHRs. Specifically, the commenters stated that the EHRs non-physician professionals often use have not been taken into account by ONC in developing the CEHRT standards and certification criteria, and therefore, they would not be able to meet the definition of CEHRT required for purposes of the Advanced APM minimum CEHRT use threshold. The commenters suggested that CMS establish a dedicated CEHRT program for non-physician and nonprescribing professionals and that CMS offer assistance in the form of funding PO 00000 Frm 00085 Fmt 4701 Sfmt 4700 59919 and technical support to help these types of clinicians participate in Advanced APMs. Response: We reiterate that the Advanced APM minimum CEHRT use threshold applies to APMs and the requirements they impose on participating APM Entities, not to the individual APM Entities participating in APMs. We also note that the Advanced APM minimum CEHRT use threshold does not mean that all eligible clinicians in each participating APM Entity are required to use CEHRT, and that the methods used in the Advanced APM to ascertain whether the required percentage of CEHRT use is met may be unique to each APM. This means there can be a percentage of eligible clinicians participating in an APM Entity who are not using CEHRT and the APM Entity will still be in compliance with the APM’s terms and conditions. Understanding this may have a greater effect on non-physician or nonprescribing eligible clinicians, moving forward, we will monitor this issue for new APMs and will consider possible solutions to facilitate participation in Advanced APMs by non-physician or non-prescribing eligible clinicians that may not use CEHRT due to lack of certified systems for that specific specialty. After considering public comments, we are finalizing our proposal that, for QP Performance Periods beginning in 2019, to be an Advanced APM, the APM must require at least 75 percent of eligible clinicians in each APM Entity (or, for APMs in which hospitals are the APM Entities, each hospital, as specified in our current regulation) to use CEHRT as defined at § 414.1305 to document and communicate clinical care with patients and other health care professionals. We are amending § 414.1414(a)(1) to reflect this change. (4) MIPS-Comparable Quality Measures (a) Overview In the CY 2017 Quality Payment Program final rule, we explained that one of the criteria for an APM to be an Advanced APM is that it must provide for payment for covered professional services based on quality measures comparable to measures under the performance category described in section 1848(q)(2)(A) of the Act, which is the MIPS quality performance category. We generally refer to these measures in the remainder of this discussion as ‘‘MIPS-comparable quality measures.’’ We also explained that we interpret this criterion to require the APM to incorporate quality measure results as a factor when determining E:\FR\FM\23NOR3.SGM 23NOR3 59920 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations amozie on DSK3GDR082PROD with RULES3 payment to participants under the terms of the APM (81 FR 77414). In the CY 2017 Quality Payment Program proposed rule, we proposed that to be an Advanced APM, an APM must base payment on quality measures that are evidence-based, reliable, and valid; and that at least one measure must be an outcome measure unless there is not an applicable outcome measure on the MIPS quality list at the time the APM is developed. The required outcome measure does not have to be one of those on the MIPS quality measure list. We did not specify that the outcome measure is required to be evidence-based, reliable, and valid. (81 FR 28302). We finalized these policies in the CY 2017 Quality Payment Program final rule and codified at § 414.1415(b). (b) General Quality Measures: EvidenceBased, Reliable, and Valid In the CY 2017 Quality Payment Program final rule, we codified at § 414.1415(b)(2) that at least one of the quality measures upon which an Advanced APM bases the payment must have an evidence-based focus, be reliable, and valid, and meet at least one of the following criteria: Used in the MIPS quality performance category as described in § 414.1330; endorsed by a consensus-based entity; developed under section 1848(s) of the Act; submitted in response to the MIPS Call for Quality Measures under section 1848(q)(2)(D)(ii) of the Act; or any other quality measures that CMS determines to have an evidence-based focus and to be reliable and valid. It has come to our attention that some have interpreted § 414.1415(b)(2) to mean that measures on the MIPS final list or submitted in response to the MIPS Call for Quality Measures necessarily are MIPS-comparable quality measures, even if they are not evidence-based, reliable, and valid. We did not intend to imply that any measure that was merely submitted in response to the annual call for quality measures or developed using Quality Payment Program funding will automatically qualify as MIPScomparable even if the measure was never endorsed by a consensus-based entity, adopted under MIPS, or otherwise determined to be evidencebased, reliable, and valid. Although we believe such measures may be evidencebased, reliable, and valid, we did not intend to consider them so for purposes of § 414.1415(b)(2) without independent verification by a consensus-based entity, or based on our own assessment and determination, that they are evidencebased, reliable, and valid. We further VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 believe the same principle applies to Qualified Clinical Data Registry (QCDR) measures. If QCDR measures are endorsed by a consensus-based entity they are presumptively considered MIPS-comparable quality measures for purposes of § 414.1415(b)(2); otherwise we would have needed independent verification, or to make our own assessment and determination, that the measures are evidence-based, reliable, and valid before considering them to be MIPS-comparable quality measures (see 81 FR 77415 through 77417). Because of the potential ambiguity in the existing definition and out of an abundance of caution to avoid any adverse impact on APM entities, eligible clinicians, or other commenters, we have used the more permissive interpretation of the regulation text, wherein measures developed under section 1848(s) of the Act and submitted in response to the MIPS Call for Quality Measures will meet the quality criterion in implementing the program thus far, and intend to use this interpretation for the 2019 QP Performance Period until our new proposal described, in this final rule, is effective on January 1, 2020. Recognizing that APMs and other payer payment arrangements that we might consider for Advanced APM and Other Payer Advanced APM determinations are well into development for 2019, we proposed to amend § 414.1415(b)(2) to be effective as of January 1, 2020. Specifically, we proposed that at least one of the quality measures upon which an Advanced APM bases payment must be finalized on the MIPS final list of measures, as described in § 414.1330; be endorsed by a consensus-based entity; or otherwise determined by CMS to be evidenced-based, reliable, and valid. That is, for QP Performance Period 2020 and all future QP Performance Periods, we would treat any measure that is either included in the MIPS final list of measures or has been endorsed by a consensus-based entity as presumptively evidence-based, reliable, and valid. All other measures would need to be independently determined by CMS to be evidence-based, reliable, and valid, to be considered MIPScomparable quality measures. We solicited comment on this proposal. The following is a summary of the public comments received on this proposal and our responses: Comment: Many commenters supported the proposal. Some commenters suggested that Advanced APMs should be required to include more than one MIPS-comparable quality measure. PO 00000 Frm 00086 Fmt 4701 Sfmt 4700 Response: We appreciate the commenters’ support of our proposal. We reiterate that the quality measures criterion stipulates that to be an Advanced APM an APM must require at least one of the quality measures upon which an Advanced APM bases payment to be MIPS-comparable. This does not preclude an Advanced APM from including more than one MIPScomparable quality measure. However, we also note that under the statute, not all quality measures under which an APM is assessed are required to be MIPS-comparable and not all payments under the APM must be based on MIPScomparable quality measures. As such, we believe that by requiring only one quality measures upon which an Advanced APM bases payment to be MIPS-comparable, APMs have the latitude to base payment on quality measures that meet the goals of the APM and assess the quality of care provided to the population of patients that the APM participants are serving. Comment: One commenter suggested that CMS consider Core Quality Measure Collaborative (CQMC) endorsement as meeting the criterion for a measure being endorsed by a consensus-based entity. The commenter noted that as more health care providers move toward the adoption of the CQMC Core Measure Sets, using the CQMC multi-stakeholder, consensus-based process in determining MIPScomparable measures would further CMS’s goal of alignment between its programs and the CQMC Core Measure Sets. Response: We note that, under MIPS, we currently try to align with the CQMC measures as much as possible. However, for a measure to meet the criterion of MIPS-comparable, only measures on the list of consensus-endorsed measures maintained by the NQF will currently meet the criterion as being endorsed by a consensus-based entity because NQF is the consensus-based entity that endorses standardized healthcare performance measures for CMS as defined under 1890(b)(2) and (3) of the Act. Therefore, CQMC endorsement does not currently meet the criterion for a measure being endorsed by a consensus-based entity. We also note, that we believe the revised criteria for the MIPS-comparable measures used in Advanced APMs do not prevent an APM from using a core measure set or using measures developed and included in other CMS programs, but instead provides the criteria for what constitutes a MIPScomparable measure to meet the Advanced APM requirement (81 FR 77417). Not all quality measures upon E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations which an APM bases payment are required to be MIPS-comparable, and not all payments under the APM must be based on MIPS-comparable measures. However, at least some payments must be tied to MIPS-comparable measures. Comment: Some commenters expressed concern that designating measures determined to be evidencedbased, reliable, and valid by CMS as MIPS-comparable amounts to bypassing the standard vetting process of consensus-based entities; publishing in applicable specialty-appropriate, peerreviewed journals; notice-and-comment rulemaking or separate publication in the Federal Register. The commenters suggested that all MIPS-comparable quality measures for the Advanced APM pathway should go through a fair and standard vetting process open to the medical profession rather than being independently determined and approved by CMS. Response: As finalized in the CY 2017 Quality Payment Program final rule, we established an Innovation Center quality measure review process for those measures that are not NQF-endorsed or included on the final MIPS measure list. The sole purpose of this process is to assess for purposes of the Advanced APM MIPS-comparable measure criterion whether these measures have an evidence-based focus, and are reliable and valid (81 FR 77418). In most instances, the Innovation Center internal committee responsible for this review process will make this determination for measures that were tested for use in Innovation Center models using internal analyses and other experts to demonstrate that the measure meets these criteria, and thus can be used as a MIPS-comparable measure before it is considered for inclusion in MIPS or submitted to the consensus based entity for endorsement consideration. The Innovation Center committee is not a substitute for those existing processes but allows the Innovation Center to innovate by using new measures that meet the same standards as MIPS measures. Therefore, we appreciate the commenters’ concerns but do not believe that the Innovation Center quality measure review process bypasses the currently established vetting process for quality measures. After considering public comments, we are finalizing our proposal to revise § 414.1415(b)(2) to clarify, effective January 1, 2020, to clarify that at least one of the quality measures upon which an Advanced APM bases payment must either be finalized on the MIPS final list of measures, as described in § 414.1330; endorsed by a consensus-based entity; VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 or determined by CMS to be evidencedbased, reliable, and valid. (c) Outcome Measures: Evidence-Based, Reliable, and Valid In § 414.1415(b)(3), we generally require that the measures upon which an Advanced APM bases payment must include at least one outcome measure, but specify that this requirement does not apply if CMS determines that there are no available or applicable outcome measures in the MIPS quality measure lists for the Advanced APM’s first QP Performance Period. We note that the current regulation does not require that the outcome measure be evidencebased, reliable, and valid. Although it was our general expectation when developing the CY 2017 Quality Payment Program final rule that outcome measures will meet this standard, we did not explicitly include this requirement. In the CY 2019 PFS proposed rule, we proposed to modify § 414.1415(b)(3) to explicitly require that an outcome measure must be evidence-based, reliable, and valid (unless, as specified in the current regulation, there is no available or applicable outcome measure), so that at least one outcome measure used for purposes of § 414.1415(b)(1) must also be: • Finalized on the MIPS final list of measures, as described in § 414.1330; • Endorsed by a consensus-based entity; or • Determined by CMS to be evidencebased, reliable, and valid. We proposed that this change would have an effective date of January 1, 2020, and would specifically require that at least one outcome measure for which measure results are included as a factor when determining payment to participants under the terms of the APM must also be a MIPS-comparable quality measure. This is intended to align with our parallel proposal for the Other Payer Advanced APM criteria that we discuss in section III.I.4.e.(3)(d)(iii) of this final rule. We solicited comment on this proposal. The following is a summary of the public comments received on this proposal and our responses: Comment: Commenters supported the proposal to explicitly require that an outcome measure must be finalized on the MIPS final list of measures; be endorsed by a consensus-based entity; or otherwise determined by CMS to be evidenced-based, reliable, and valid. One commenter noted that this proposal is reasonable given the general growth in the use of outcome measures. PO 00000 Frm 00087 Fmt 4701 Sfmt 4700 59921 Response: We appreciate the commenters’ support, but note that our proposal does not eliminate the exception for models where there are no available or applicable outcome measures at the performance start date of the model. Comment: One commenter expressed concerns with the proposal to explicitly require that an outcome measure must be finalized on the MIPS final list of measures; be endorsed by a consensusbased entity; or otherwise determined by CMS to be evidenced-based, reliable, and valid. The commenter noted that there is little variation in outcomes for many surgical procedures as judged by existing outcome measures, and that outcome measures alone are not sufficient to verify that the highest quality care is made available to patients. The commenter suggested CMS implement a framework that could provide a much clearer picture of the quality of care provided to the patient and includes elements such as: Standards-based facility-level verification programs; patient reported experience and outcomes measures; and traditional quality measures including registry and claims-based measures. Response: We acknowledge the commenter’s concerns regarding this use of outcomes measures and appreciate the commenter’s suggestions. The Advanced APM requirement for inclusion of one MIPS-comparable measure that is also an outcome measure does not represent a quality measure strategy for Advanced APMs. Rather, the statute identifies outcome measures as a priority measure type, and we wanted to encourage the use of outcome measures for quality performance assessment in APMs. The quality strategy for most Advanced APMs typically includes quality and/or utilization measures that correspond with the key payment and practice transformation activities being tested in the APM. This is why the majority of APMs include more than just one quality measure and many different types of quality performance measures (for example, process, clinical outcome, patient experience of care or patient reported outcome measures) to assess the clinical care provided by eligible clinicians under the APM. Our goal in developing APMs is to ensure that all patients realize better care, improved clinical outcomes and more efficient cost-effective care. We believe our requirement that at least one outcome measure for which measure results are included as a factor when determining payment to participants under the terms of the APM must also be a MIPS- E:\FR\FM\23NOR3.SGM 23NOR3 59922 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations comparable quality measure further reinforces these goals. Comment: One commenter expressed concern that CMS is placing too much emphasis on outcome measures. Specifically, the commenter suggested that CMS continue to support the use of process measures until meaningful outcome measures are available in more specialty areas. Response: We note that we require only one of the quality measures to be an outcome measure, and have established an exception for models where there is no available or applicable outcome measure at the performance start date of the model. As such, we do not agree that we are emphasizing outcome measures over process measures. After considering public comments, we are finalizing our proposal to revise § 414.1415(b)(3), effective January 1, 2020, to require that at least one outcome measure, for which measure results are included as a factor when determining payment to participants under the terms of the APM, must either be finalized on the MIPS final list of measures as described in § 414.1330, endorsed by a consensus-based entity; or determined by CMS to be evidencebased, reliable, and valid. As specified in the current regulation, this requirement does not apply if CMS determines that there are no available or applicable outcome measures included in the MIPS quality measures list for the Advanced APM’s first QP Performance Period. (5) Bearing Financial Risk for Monetary Losses amozie on DSK3GDR082PROD with RULES3 (a) Overview In the CY 2017 Quality Payment Program final rule, we finalized the amount of the generally applicable revenue-based nominal amount standard at 8 percent for the first two QP Performance Periods only, and we sought comment on what the revenuebased nominal amount standard should be for the third and subsequent QP Performance Periods. Specifically, we sought comment on: (1) Setting the revenue-based standard for 2019 and later at up to 15 percent of revenue; or (2) setting the revenue-based standard at 10 percent so long as risk is at least equal to 1.5 percent of expected expenditures for which an APM Entity is responsible under an APM (81 FR 77427). In the CY 2018 Quality Payment Program final rule, we finalized our proposal to maintain the generally applicable revenue-based nominal amount standard at 8 percent for the VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 2019 and 2020 QP Performance Periods at § 414.1415(c)(3)(i)(A). We also specified that the standard is based on the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities. We stated that we will address the nominal amount standard for QP Performance Periods after 2020 in future rulemaking (82 FR 53838). (b) Generally Applicable Nominal Amount Standard We proposed to amend § 414.1415(c)(3)(i)(A) to maintain the generally applicable revenue-based nominal amount standard at 8 percent of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities for QP Performance Periods 2021 through 2024. We solicited comment on this proposal. The following is a summary of the public comments received on this proposal and our responses: Comment: Many commenters supported our proposal to maintain the 8 percent generally applicable revenuebased standard for QP performance periods 2021–2024. Commenters noted that maintaining the 8 percent revenuebased standard through the 2024 QP performance period will promote consistency for participants across performance periods and further support CMS’ efforts to transition clinicians into Advanced APMs. Response: We appreciate the commenters’ support of our proposal to maintain the 8 percent generally applicable revenue-based standard for QP performance periods 2021–2024. Comment: Two commenters suggested that we limit the generally applicable revenue-based nominal amount standard to only include the average estimated total Part B revenue of participating providers and suppliers in APM Entities, rather than the average estimated total Part A and Part B revenues of providers and suppliers in APM Entities. The commenters stated that by including Part A revenue, CMS significantly disadvantages APM Entities, such as ACOs, that have hospital participants. The commenters noted that the APM Incentive Payment is based on payments for Part B covered professional services under the Medicare PFS, and as such, recommends that we revise the generally applicable revenue-based nominal amount standard to only consider Part B revenue under the Medicare PFS. Response: We note that we did not propose to make changes to the types of PO 00000 Frm 00088 Fmt 4701 Sfmt 4700 revenue that are included in the generally applicable revenue-based nominal amount standard. However, we note that we disagree that the generally applicable revenue-based nominal amount standard should only include Part B revenues, as many APM Entities participating in Advanced APMs often include hospitals and other types of institutional providers or suppliers that may receive both Part A and B revenues. Additionally, the generally applicable revenue-based nominal amount standard is inclusive only of the Medicare Part A and B revenues of providers and suppliers in participating APM Entities; therefore, if the providers and suppliers in a given APM Entity have only Medicare Part B revenues, only such revenues will be considered. Comment: Some commenters suggested we reconsider establishing a separate, lower nominal amount standard for small and rural practices. The commenters stated that a lower revenue-based nominal amount standard is necessary to ensure that the challenging operational risks and expenses, which put such practices at greater financial risk when compared to larger practices, do not prevent participation in Advanced APMs. The commenters suggested establishing a nominal amount standard for small and rural practices that would be aligned with the Medical Home Model nominal amount standard or set equal to the percentage of the APM incentive payment that an eligible clinician might attain based on their participation in an Advanced APM. The commenters noted that a lower revenue-base nominal amount standard may encourage greater participation in APMs by small and rural practices. Response: We will continue to monitor the impact of the generally applicable revenue-based nominal amount standard and Medical Home Model nominal amount standard on small practices and those in rural areas. We did not include any proposals in the CY 2019 PFS proposed rule regarding a separate standard for small or rural practices, but may consider revisiting establishing a lower revenue-based nominal amount standard for small practices and those in rural areas in future rulemaking. Comment: Some commenters requested CMS consider the financial and administrative risk that nonphysician practitioners face when joining Advanced APMs. Specifically, the commenters suggested that CMS should adopt a more inclusive interpretation of financial risk for monetary losses by including any losses incurred in the operation of the APM E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations Entity rather than limiting financial risk only to losses or increased spending in the Medicare program. The commenters stated that the magnitude of risk CMS currently requires for participation in an Advanced APM may prevent many eligible clinicians from considering participation in the limited Advanced APMs available. Response: As we stated in the CY 2018 Quality Payment Program final rule, we recognize the substantial investments that many APM Entities make to become successful APM participants, and also the financial and administrative burden that eligible clinicians of all types face when deciding to join an APM Entity. Nonetheless, as we discussed in the CY 2017 Quality Payment Program final rule, we continue to believe that there would be significant complexity involved in creating an objective and enforceable standard for determining whether an entity’s business risk exceeds a nominal amount. We also reiterate that business risk is generally a cost that is unrelated to performancebased payment under an APM. No matter how well or poorly an APM Entity performs when assessed for purposes of the APM, costs associated with business risk are not reduced or increased correspondingly. Therefore, we maintain our view that business risk is not analogous to performance risk in the APM context because the costs of those activities and investments are not incorporated into the performancebased financial calculations of an APM, and are therefore not appropriate for consideration for purposes of the Advanced APM financial risk criterion (81 FR 77420). After considering public comments, we are finalizing our proposal to revise § 414.1415(c)(3)(i)(A) to maintain the generally applicable revenue-based nominal amount standard at 8 percent of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities for QP Performance Periods 2021 through 2024. We continue to believe that 8 percent of Medicare Parts A and B revenues of all providers and suppliers in participating APM Entities generally represents an appropriate standard for more than a nominal amount of financial risk at this time. We also believe that maintaining a consistent standard for several more years will help APM Entities to plan for multi-year Advanced APM participation. We further believe that maintaining a consistent standard will allow us to evaluate how APM Entities succeed within these parameters over the applicable timeframe. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 We also sought comment on whether, as APM entities and participating eligible clinicians grow more comfortable with assuming risk, we should consider increasing the nominal amount standard. Specifically, we requested comments on whether we should consider raising the revenuebased nominal amount standard to 10 percent, and the expenditure-based nominal amount standard to 4 percent starting for QP Performance Periods in 2025 and later. Several comments stated we should consider raising the revenue-based nominal amount standard to 10 percent, and the expenditure-based nominal amount standard to 4 percent starting for QP Performance Periods in 2025 and later. We thank commenters for their feedback and will take this input into consideration for future years. (6) Summary of Final Policies Use of CEHRT • We are finalizing revisions to § 414.1415(a)(i) to specify that an Advanced APM must require at least 75 percent of eligible clinicians in each APM Entity, or, for APMs in which hospitals are the APM Entities, each hospital, to use CEHRT as defined at § 414.1305 to document and communicate clinical care with patients and other health care professionals. MIPS-Comparable Quality Measures • We are finalizing revisions to clarify at § 414.1415(b)(2), effective January 1, 2020, that at least one of the quality measures upon which an Advanced APM bases the payment in paragraph (b)(1) of this section must either be finalized on the MIPS final list of measures, as described in § 414.1330; endorsed by a consensus-based entity; or determined by CMS to be evidencedbased, reliable, and valid. • We are finalizing revisions at § 414.1415(b)(3), effective January 1, 2020, to provide that at least one outcome measure, for which measure results are included as a factor when determining payment to participants under the terms of the APM must either be finalized on the MIPS final list of measures as described in § 414.1330, endorsed by a consensus-based entity; or determined by CMS to be evidencebased, reliable, and valid. Bearing Financial Risk for Monetary Losses • We are finalizing revisions at § 414.1415(c)(3)(i)(A) to maintain the generally applicable revenue-based nominal amount standard at 8 percent of the average estimated total Medicare Parts A and B revenue of all providers PO 00000 Frm 00089 Fmt 4701 Sfmt 4700 59923 and suppliers in participating APM Entities for QP Performance Periods 2021 through 2024. d. Qualifying APM Participant (QP) and Partial QP Determinations (1) Overview We finalized policies relating to QP and Partial QP determinations in the CY 2017 Quality Payment Program final rule (81 FR 77433 through 77450). (2) Summary of Proposals In the CY 2019 PFS proposed rule (83 FR 3599 through 35994), we included the following proposals, each of which is discussed in further detail below: QP Performance Period • We proposed that for each of the three QP determinations, we will allow for claims run-out for 60 days (approximately 2 months), before calculating the Threshold Scores so that the three QP determinations can be completed approximately 3 months after the end of that determination time period. Partial QP Election To Report to MIPS • We proposed that when an eligible clinician is determined to be a Partial QP for a year at the individual eligible clinician level, the individual eligible clinician will make an election whether to report to MIPS. If the eligible clinician elects to report to MIPS, they will be subject to the MIPS reporting requirements and payment adjustment. If the eligible clinician elects not to report, they will be excluded from the MIPS reporting requirements and payment adjustment. In the absence of an explicit election to report to MIPS, the eligible clinician will be excluded from the MIPS reporting requirements and payment adjustment. This means that no actions other than the eligible clinician’s affirmative election to participate in MIPS will result in that eligible clinician becoming subject to the MIPS reporting requirements and payment adjustment. (3) QP Performance Period In the CY 2017 Quality Payment Program final rule, we finalized for the timing of QP determinations that a QP Performance Period runs from January 1 through August 31 of the calendar year that is 2 years prior to the payment year (81 FR 77446–77447). During that QP Performance Period, we will make QP determinations at three separate snapshot dates (March 31, June 30, and August 31), each of which will be a final determination for the eligible clinicians who are determined to be QPs. The QP Performance Period and the three E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59924 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations separate QP determinations apply similarly for both the group of eligible clinicians on a Participation List and the individual eligible clinicians on an Affiliated Practitioner List. We also finalized that for each of the three QP determinations, we will allow for claims run-out for 3 months, or 90 days, before calculating the Threshold Scores so that QP determinations will be completed approximately 4 months after each snapshot date. As a result, the last of these three QP determinations is complete on or around January 1 of the subsequent calendar year, which is the year immediately prior to the MIPS payment year. For most MIPS data submission types, January 1 of the subsequent calendar year is also the beginning of the MIPS data submission period. This way, eligible clinicians know of their QP status prior to or near the beginning of the MIPS data submission period and know whether they should report any performance period data to MIPS for the applicable MIPS payment year. Upon further consideration and based on our experience implementing the program to date, we believe providing eligible clinicians notification of their QP status more quickly after each of the three QP determination snapshot dates, and prior to the beginning of the MIPS data submission period after the last determination, will potentially reduce burden for eligible clinicians and APM Entities while improving their overall experience participating in the program. We proposed that beginning in 2019 for each of the three QP determination dates, we will allow for claims run-out for 60 days (approximately 2 months), before calculating the Threshold Scores so that the three QP determinations will be completed approximately 3 months after the end of that determination time period. We note that this proposal does not affect the QP Performance Period per se, but rather the date by which claims for services furnished during the QP Performance Period will need to be processed for those services to be included in calculating the Threshold Scores. To the extent that claims are used for calculating the Threshold Scores, such claims will have to be processed by no later than 60 days after each of the three QP determination dates, for information on the claims to be included in our calculations. We solicited comment on this proposal. The following is a summary of the public comments received on this proposal and our responses: Comment: Many commenters supported the proposal to allow for claims run-out of 60 days VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 (approximately 2 months), before calculating the QP threshold scores so that the three QP determinations can be completed approximately 3 months after the end of that determination time period. Commenters noted the importance for APM Entities to have information about their QP status as soon as possible after each snapshot to determine if they will need to take any additional action to report to MIPS or seek a QP determination under the AllPayer Combination Option should they fall short of the QP thresholds under the Medicare Option. Response: We appreciate the commenters’ support of our proposal to allow for a claims run-out of 60 days before calculating the QP threshold scores so that the three QP determinations can be completed approximately 3 months after the end of that determination time period. After considering public comments, we are finalizing our proposal that for each of the three QP determinations, we will allow for claims run-out for 60 days (approximately 2 months), before calculating the Threshold Scores so that the three QP determinations can be completed approximately 3 months after the end of that determination time period. (4) Partial QP Election To Report to MIPS (a) Overview Section 1848(q)(1)(C)(ii)(II) of the Act excludes from the definition of MIPS eligible clinician an eligible clinician who is a Partial QP for a year and who does not report on applicable measures and activities as required under MIPS for the year. However, under section 1848(q)(1)(C)(vii) of the Act, an eligible clinician who is a Partial QP for a year and reports on applicable measures and activities as required under the MIPS is considered to be a MIPS eligible clinician for the year. In the CY 2017 Quality Payment Program final rule, we finalized that following a determination that eligible clinicians in an APM Entity group in an Advanced APM are Partial QPs for a year, the APM Entity will make an election whether to report on applicable measures and activities as required under MIPS. If the APM Entity elects to report to MIPS, all eligible clinicians in the APM Entity will be subject to the MIPS reporting requirements and payment adjustments for the relevant year. If the APM Entity elects not to report, all eligible clinicians in the APM Entity group will be excluded from the MIPS reporting requirements and PO 00000 Frm 00090 Fmt 4701 Sfmt 4700 payment adjustments for the relevant year (81 FR 77449). We also finalized that in cases where the Partial QP determination is made at the individual eligible clinician level, if the individual eligible clinician is determined to be a Partial QP, the eligible clinician will make the election whether to report on applicable measures and activities as required under MIPS and, as a result, be subject to the MIPS reporting requirements and payment adjustment (81 FR 77449). If the individual eligible clinician elects to report to MIPS, he or she will be subject to the MIPS reporting requirements and payment adjustments for the relevant year. If the individual eligible elects not to report to MIPS, he or she will be excluded from the MIPS reporting requirements and payment adjustments for the relevant year. We note that QP determinations are made at the individual eligible clinician level when the clinician is identified as participating in an Advanced APM on an Affiliated Practitioner List rather than a Participation List, or when an eligible clinician is in more than one APM Entity group in one or more Advanced APMs, and does not achieve QP status as part of any single APM Entity group (see § 414.1425(b)(2) and (c)(4) our regulations). We also clarified how we consider the absence of an explicit election to report to MIPS or to be excluded from MIPS. We finalized that for situations in which the APM Entity is responsible for making the decision on behalf of all eligible clinicians in the APM Entity group, the group of Partial QPs will not be considered MIPS eligible clinicians unless the APM Entity opts the group into MIPS participation, so that no actions other than the APM Entity’s election for the group to participate in MIPS will result in MIPS participation (81 FR 77449). For eligible clinicians who are determined to be Partial QPs individually, we finalized that we will use the eligible clinician’s actual MIPS reporting activity to determine whether to exclude the Partial QP from MIPS in the absence of an explicit election. Therefore, if an eligible clinician who is individually determined to be a Partial QP submits information to MIPS (not including information automatically populated or calculated by CMS on the Partial QP’s behalf), we will consider the Partial QP to have reported, and thus to be participating in MIPS. Likewise, if such an individual does not take any action to submit information to MIPS, we will consider the Partial QP to have elected to be excluded from MIPS (81 FR 77449). E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations amozie on DSK3GDR082PROD with RULES3 (b) Alignment of Partial QP Election Policies We proposed that when an eligible clinician is determined to be a Partial QP for a year at the individual eligible clinician level, the individual eligible clinician will make an election whether to report to MIPS. If the eligible clinician elects to report to MIPS, they will be subject to MIPS reporting requirements and payment adjustments. If the eligible clinician elects to not report to MIPS, they will not be subject to the MIPS reporting requirements and payment adjustment. If the eligible clinician does not make any election, they will not be subject to the MIPS reporting requirements and payment adjustment. We note that this proposed policy change would affect only situations where the Partial QP makes no election to either report to MIPS or to be excluded from the MIPS reporting requirements and payment adjustment. Under our proposed policy, all Partial QPs retain the full right to affirmatively decide through the election process whether or not to be subject to the MIPS reporting requirements and payment adjustment; whereas, if the Partial QP does not make any election, they will not be subject to the MIPS reporting requirements and payment adjustment. We solicited comment on this proposal. The following is a summary of the public comments received on this proposal and our responses: Comment: Some commenters supported our proposal. Specifically, the commenters supported our proposal to exclude eligible clinicians determined to be a Partial QP for a year at the individual eligible clinician level from the MIPS reporting requirements and payment adjustment, in the absence of an explicit election to report to MIPS. Commenters noted this proposal will help to avoid confusion and prevent inadvertently subjecting eligible clinicians to MIPS reporting requirements and payment adjustments when information has been reported on their behalf. Response: We appreciate the commenters’ support of our proposal to align the Partial QP election policy for eligible clinicians who are determined to be Partial QPs individually and for eligible clinicians who are determined to be Partial QPs at the APM Entity level. Comment: One commenter expressed concern that our proposal may create additional confusion for eligible clinicians. Specifically, the commenter noted that many eligible clinicians may VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 not be aware that they attained Partial QP status, and that an affirmative election is required to participate in MIPS. The commenter also noted that such clinicians may assume that their MIPS data is being reported on their behalf by their practice or TIN, and as a result may inadvertently forego a potential positive MIPS payment adjustment. The commenter suggested an alternative approach where CMS would apply the policy which yields the most advantageous MIPS final score and subsequently the most advantageous MIPS payment adjustment. The commenter noted that this alternative approach would work in such a manner that in cases where data is submitted by a Partial QP, or on their behalf, that would earn the Partial QP a MIPS final score resulting in a positive MIPS payment adjustment, CMS would use that data to provide them a MIPS final score, regardless of whether they made an election to participate in MIPS. In cases where data is submitted by a Partial QP, or on their behalf, that would earn the Partial QP a MIPS final score resulting in a negative MIPS payment adjustment, CMS would not use that data to provide them a MIPS final score, and they would be exempt from MIPS based on the Partial QP status. The commenter noted this alternative approach would eliminate all potential unintended consequences and would be consistent with other CMS policies to use data that yields the most advantageous result. The commenter also noted the alternative approach may further incentivize participation in APMs and reduce burden on both eligible clinicians and CMS because eligible clinicians would no longer have to make an election to affirmatively optin or opt-out of MIPS. Response: We acknowledge that our proposal could, in certain limited instances, create additional confusion for eligible clinicians, particularly eligible clinicians who may not be aware that they attained Partial QP status and an affirmative election is required for them to participate in MIPS. However, we note that clinicians’ QP status, including Partial QP status, is accessible via the QPP Participation Status Tool via the Quality Payment Program website at https://qpp.cms.gov/ participation-lookup. We also continue to believe our proposed approach will allow for greater operational simplicity while minimizing the possibility of unexpected participation in MIPS. We reiterate that all Partial QPs retain the full right to affirmatively decide through the election process whether or not to be PO 00000 Frm 00091 Fmt 4701 Sfmt 4700 59925 subject to the MIPS reporting requirements and payment adjustment. After considering public comments, we are finalizing our proposal that when an eligible clinician is determined to be a Partial QP for a year at the individual eligible clinician level, the individual eligible clinician will make an election whether to report to MIPS. If the eligible clinician elects to report to MIPS, they will be subject to the MIPS reporting requirements and payment adjustment. If the eligible clinician elects not to report, they will be excluded from the MIPS reporting requirements and payment adjustment. In the absence of an explicit election to report to MIPS, the eligible clinician will be excluded from the MIPS reporting requirements and payment adjustment. This means that no actions other than the eligible clinician’s affirmative election to participate in MIPS would result in that eligible clinician becoming subject to the MIPS reporting requirements and payment adjustment. (5) Summary of Final Policies In this section, we are finalizing the following policies: QP Performance Period • We are finalizing our proposal that for each of the three QP determinations, we will allow for claims run-out for 60 days (approximately 2 months), before calculating the Threshold Scores so that the three QP determinations can be completed approximately 3 months after the end of that determination time period. Partial QP Election To Report to MIPS • We are finalizing our proposal that when an eligible clinician is determined to be a Partial QP for a year at the individual eligible clinician level, the individual eligible clinician will make an election whether to report to MIPS. If the eligible clinician elects to report to MIPS, they will be subject to the MIPS reporting requirements and payment adjustment. If the eligible clinician elects not to report, they will be excluded from the MIPS reporting requirements and payment adjustment. In the absence of an explicit election to report to MIPS, the eligible clinician will be excluded from the MIPS reporting requirements and payment adjustment. This means that no actions other than the eligible clinician’s affirmative election to participate in MIPS would result in that eligible clinician becoming subject to the MIPS reporting requirements and payment adjustment. E:\FR\FM\23NOR3.SGM 23NOR3 59926 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations e. All-Payer Combination Option (1) Overview APM criteria with payers other than Medicare. It also encourages sustained participation in Advanced APMs across multiple payers. We finalized that the QP determinations under the All-Payer Combination Option are based on payment amounts or patient counts as illustrated in Tables 36 and 37, and Figures 1 and 2 of the CY 2017 Quality Payment Program final rule (81 FR 77460 through 77461). We also finalized that, in making QP determinations with respect to an eligible clinician, we will use the Threshold Score that is most advantageous to the eligible clinician toward achieving QP status, or if QP status is not achieved, Partial QP status, for the year (81 FR 77475). ER23NO18.074</GPH> BILLING CODE 4120–01–P VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00092 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.073</GPH> amozie on DSK3GDR082PROD with RULES3 Section 1833(z)(2)(B)(ii) of the Act requires that beginning in payment year 2021, in addition to the Medicare Option, eligible clinicians may become QPs through the Combination All-Payer and Medicare Payment Threshold Option, which we refer to as the AllPayer Combination Option. In the CY 2017 Quality Payment Program final rule, we finalized our overall approach to the All-Payer Combination Option (81 FR 77459). The Medicare Option focuses on participation in Advanced APMs, and we make QP determinations under this option based on Medicare Part B covered professional services attributable to services furnished through an APM Entity. The All-Payer Combination Option does not replace or supersede the Medicare Option; instead, it will allow eligible clinicians to become QPs by meeting the QP thresholds through a pair of calculations that assess a combination of both Medicare Part B covered professional services furnished through Advanced APMs and services furnished through Other Payer Advanced APMs. We finalized that beginning in payment year 2021, we will conduct QP determinations sequentially so that the Medicare Option is applied before the All-Payer Combination Option (81 FR 77438). The All-Payer Combination Option encourages eligible clinicians to participate in payment arrangements that satisfy the Other Payer Advanced Unlike the Medicare Option, where we have access to all of the information necessary to determine whether an APM meets the criteria to be an Advanced APM, we cannot determine whether an other payer arrangement meets the criteria to be an Other Payer Advanced APM without receiving information about the payment arrangement from an external source. Similarly, we do not have the necessary payment amount and patient count information to determine under the All-Payer Combination Option whether an eligible clinician meets the payment amount or patient VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 count threshold to be a QP without receiving certain information from an external source. In the CY 2018 Quality Payment Program final rule, we established additional policies to implement the All-Payer Combination Option and finalized certain modifications to our previously finalized policies (82 FR 53844 through 53890). A detailed summary of those policies can be found at 82 FR 53874 through 53876 and 53890 through 53891. In relevant part, we finalized the following: PO 00000 Frm 00093 Fmt 4701 Sfmt 4700 59927 Payer Initiated Process • We finalized at § 414.1445(a) and (b)(1) that certain other payers, including payers with payment arrangements authorized under Title XIX (the Medicaid statute), Medicare Health Plan payment arrangements, and payers with payment arrangements aligned with a CMS Multi-Payer Model, can request that we determine whether their other payer arrangements are Other Payer Advanced APMs starting prior to the 2019 QP Performance Period and each year thereafter. We finalized that Remaining Other Payers, including E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.075</GPH> amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 59928 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations commercial and other private payers, could request that we determine whether other payer arrangements are Other Payer Advanced APMs starting in 2019 prior to the 2020 QP Performance Period, and annually each year thereafter. We generally refer to this process as the Payer Initiated Other Payer Advanced APM Determination Process (Payer Initiated Process), and we finalized that the Payer Initiated Process would generally involve the same steps for each payer type for each QP Performance Period. If a payer uses the same other payer arrangement in other commercial lines of business, we finalized our proposal to allow the payer to concurrently request that we determine whether those other payer arrangements are Other Payer Advanced APMs as well. This policy is relevant only to the initial year of Payer Initiated Other Payer Advanced APM determinations for which these submissions can be made only by payers with arrangements under Title XIX, Medicare Health Plans, or arrangements aligned with CMS multi-payer models. amozie on DSK3GDR082PROD with RULES3 Eligible Clinician Initiated Process • We finalized at § 414.1445(a) and (b)(2) that, through the Eligible Clinician Initiated Process, APM Entities and eligible clinicians participating in other payer arrangements would have an opportunity to request that we determine for the year whether those other payer arrangements are Other Payer Advanced APMs. The Eligible Clinician Initiated Process can be used to submit requests for determinations before the beginning of a QP Performance Period for other payer arrangements authorized under Title XIX. The Eligible Clinician Initiated Process is available for the 2019 QP Performance Period and each year thereafter. Submission of Information for Other Payer Advanced APM Determinations • We finalized that, for each other payer arrangement for which a payer requests us to make an Other Payer Advanced APM determination, the payer must complete and submit the Payer Initiated Submission Form by the relevant Submission Deadline. • We finalized that, for each other payer arrangement for which an APM Entity or eligible clinician requests us to make an Other Payer Advanced APM determination, the APM Entity or eligible clinician must complete and submit the Eligible Clinician Initiated Submission Form by the relevant Submission Deadline. • We removed the requirement, previously established at VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 § 414.1445(b)(3), that payers must attest to the accuracy of information submitted by eligible clinicians, and we also removed the related attestation requirement at § 414.1460(c). Instead, we finalized an additional requirement at § 414.1445(d) that an APM Entity or eligible clinician that submits information under § 414.1445(c) must certify that, to the best of its knowledge, the information it submits to us is true, accurate, and complete. QP Determinations Under the All-Payer Combination Option • We finalized at § 414.1440(e) that eligible clinicians may request that we make QP determinations at the individual eligible clinician level and that APM Entities may request that we make QP determinations at the APM Entity level. • We finalized at § 414.1440(d)(1) that we will make QP determinations under the All-Payer Combination Option based on eligible clinicians’ participation in Advanced APMs and Other Payer Advanced APMs for three time periods of the QP Performance Period: January 1 through March 31; January 1 through June 30; and January 1 through August 31. We finalized that we will use patient or payment data for the same time periods to calculate both the Medicare and the other payer portion of the Threshold Score calculation under the All-Payer Cominbation Option. • We finalized at § 414.1440(e)(4) that, to request a QP determination under the All-Payer Combination Option, APM Entities or eligible clinicians must submit all of the payment amount and patient count information sufficient for us to make QP determinations by December 1 of the calendar year that is 2 years to prior to the payment year, which we refer to as the QP Determination Submission Deadline. In this section of the final rule, we address policies within the following topics: Other Payer Advanced APM Criteria; Other Payer Advanced APM determinations; and Calculation of the All-Payer Combination Option Threshold Scores and QP Determinations. (2) Summary of Proposals In the CY 2019 PFS proposed rule (83 FR 35999–36006), we included the following proposals, each of which is discussed below: Other Payer Advanced APM Criteria • We proposed to change the CEHRT use criterion so that in order to qualify as an Other Payer Advanced APM as of January 1, 2020, the other payer PO 00000 Frm 00094 Fmt 4701 Sfmt 4700 arrangement must require at least 75 percent of participating eligible clinicians in each APM Entity use CEHRT. • We proposed to allow payers and eligible clinicians to submit evidence as part of their request for an Other Payer Advanced APM determination that CEHRT is used by the requisite percentage of eligible clinicians participating in the payment arrangement (50 percent for 2019, and 75 percent for 2020 and beyond) to document and communicate clinical care, whether or not CEHRT use is explicitly required under the terms of the payment arrangement. • We proposed the following clarification to § 414.1420(c)(2), effective January 1, 2020, to provide that at least one of the quality measures used in the payment arrangement in paragraph (c)(1) of this regulation must be: ++ Finalized on the MIPS final list of measures, as described in § 414.1330; ++ Endorsed by a consensus-based entity; or ++ Determined by CMS to be evidenced-based, reliable, and valid. • We proposed to revise § 414.1420(c)(3) to require that, effective January 1, 2020, unless there is no applicable outcome measure on the MIPS quality measure list, an Other Payer Advanced APM must use an outcome measure, that must be: ++ Finalized on the MIPS final list of measures, as described in § 414.1330; ++ Endorsed by a consensus-based entity; or ++ Determined by CMS to be evidenced-based, reliable, and valid. • We also proposed to revise our regulation at § 414.1420(c)(3)(i) to provide that, for payment arrangements determined to be Other Payer Advanced APMs for the 2019 performance year that did not include an outcome measure that is evidence-based, reliable, and valid, and that are resubmitted for an Other Payer Advanced APM determination for the 2020 performance year (whether for a single year, or for a multi-year determination as proposed in section III.I.4.e.(4)(b) of this final rule), we would continue to apply the current regulation for purposes of those determinations. This proposed revision also applies to payment arrangements in existence prior to the 2020 performance year that are submitted for determination to be Other Payer Advanced APMs for the 2020 performance year and later. E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations Determination of Other Payer Advanced APMs • We proposed details regarding the Payer Initiated Process for Remaining Other Payers. To the extent possible, we aligned the Payer Initiated Process for Remaining Other Payers with the previously finalized Payer Initiated Process for Medicaid, Medicare Health Plans, and CMS Multi-Payer Models. • We proposed to eliminate the Payer Initiated Process that is specifically for CMS Multi-Payer Models. We believe that payers aligned with CMS MultiPayer Models can submit their arrangements through the Payer Initiated Process for Remaining Other Payers proposed in section III.I.4.e.(4)(c) of this final rule, or through the Medicaid or Medicare Health Plan payment arrangement submission processes. amozie on DSK3GDR082PROD with RULES3 Calculation of All-Payer Combination Option Threshold Scores and QP Determinations • We proposed to add a third alternative to allow requests for QP determinations at the TIN level in instances where all clinicians who reassigned billing rights under the TIN participate in a single APM Entity. We proposed to modify our regulation at § 414.1440(d) by adding this third alternative to allow QP determinations at the TIN level in instances where all clinicians who have reassigned billing under the TIN participate in a single APM Entity, as well as to assess QP status at the most advantageous level for each eligible clinician. • We also clarified that, in making QP determinations using the All-Payer Combination Option, eligible clinicians may meet the minimum Medicare threshold using one method, and the All-Payer threshold using the same or a different method. We proposed to codify this clarification by adding § 414.1440(d)(4). • We proposed to extend the weighting methodology that is used to ensure that an eligible clinician does not receive a lower score on the Medicare portion of their all-payer calculation under the All-Payer Combination Option than the Medicare Threshold Score they received at the APM Entity level in order to apply a similar policy to the proposed TIN level Medicare Threshold Scores. (3) Other Payer Advanced APM Criteria (a) Overview In general, our goal is to align the Advanced APM criteria under the Medicare Option and the Other Payer Advanced APM criteria under the All- VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 Payer Combination Option as permitted by statute and as feasible and appropriate. We believe this alignment helps simplify the Quality Payment Program and encourage participation in Other Payer Advanced APMs (82 FR 53847). (b) Investment Payments Some stakeholders have requested that we take into account ‘‘business risk’’ costs such as IT, personnel, and other administrative costs associated with APM Entities’ participation in Other Payer Advanced APMs when implementing the financial risk standard. We did not propose to modify our financial risk standard in response to this suggestion, and note that financial risk in the context of Other Payer Advanced APMs is defined both in the Act (at section 1833(z)(2)(B)(iii)(II)(cc) for payment years 2021 and 2022, and section 1833(z)(3)(B)(iii)(II)(cc) for subsequent years) and our regulations at § 414.1420(d) so as to require that APM Entities in the payment arrangement must assume financial risk when actual expenditures exceed expected expenditures. However, we note that a payment arrangement with an other payer, like some APMs, can be structured so that the APM provides an investment payment to the participating APM Entities to assist with the practice transformation that may be required for participation in the payment arrangement. This investment payment could be structured in various ways; for example, it could be structured similarly to the Medicare ACO Investment Model under, which expected shared savings payment were pre-paid to encourage new ACOs to form in rural and underserved areas and to assist existing ACOs in meeting certain criteria; or it could be structured so that the payment is made specifically to encourage participating APM Entities to continue to make staffing, infrastructure, and operations investments as a means of practice transformation; or it could have a different structure entirely. Although CMS did not solicit comments regarding our statement on investment payments, the following is a summary of the public comments we received: Comment: Many commenters expressed concern that CMS will continue the current policy that does not include investment payments in the definition and calculation of risk. The commenters stated that this approach fails to recognize the significant investment that APM Entities and eligible clinicians make in start-up and PO 00000 Frm 00095 Fmt 4701 Sfmt 4700 59929 overhead costs in the development and operations of APMs. Some commenters suggested that CMS should develop a method to capture and quantify such risk. Response: We reiterate that our policy has not changed. As we discussed in the CY 2017 Quality Payment Program final rule, we continue to believe that there would be significant complexity involved in creating an objective and enforceable standard for determining whether an entity’s investment risk or business risk exceeds a nominal amount (81 FR 77420). Therefore, we maintain our view that investment risk or business risk is not analogous to performance risk in the APM context because the costs of those activities and investments are not incorporated into the performance-based financial calculations of an APM, and therefore, are not appropriate for consideration for purposes of the Advanced APM financial risk criterion (81 FR 77420). Other Payer Advanced APMs, like Advanced APMs, can be designed so that they include investment payments for participants, but those investment payments will not be considered financial risk when assessing whether a payment arrangement meets the Other Payer Advanced APM financial risk criterion. (c) Use of CEHRT (i) Overview In the CY 2017 Quality Payment Program final rule, we finalized that to be an Other Payer Advanced APM, the other payer arrangement must require at least 50 percent of participating eligible clinicians in each APM Entity, or each hospital if hospitals are the APM Entities, to use CEHRT to document and communicate clinical care (81 FR 77465). This CEHRT use criterion directly paralleled the criterion established for Advanced APMs in § 414.1415(a)(1)(i). In the CY 2018 Quality Payment Program final rule, we finalized that we would presume that an other payer arrangement meets the 50 percent CEHRT use criterion if we receive information and documentation from the eligible clinician through the Eligible Clinician Initiated Process showing that the other payer arrangement requires the requesting eligible clinician to use CEHRT to document and communicate clinical care (see § 414.1445(c)(2)). (ii) Increasing the CEHRT Use Criterion for Other Payer Advanced APMs We proposed to change the current CEHRT use criterion for Other Payer E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59930 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations Advanced APMs so that in order to qualify as an Other Payer Advanced APM as of January 1, 2020, the other payer arrangement must require at least 75 percent of participating eligible clinicians in each APM Entity to use CEHRT; this aligns with our proposals for the CEHRT use criterion for Advanced APMs. According to data collected by ONC, since the CY 2017 Quality Payment Program final rule was published, EHR adoption has been widespread, and we want to encourage continued adoption. Additionally, in response to the CY 2017 Quality Payment Program proposed rule stakeholders encouraged us to raise the CEHRT use criterion to 75 percent (see 81 FR 77411). We believe that this proposed change aligns with the increased adoption of CEHRT among providers and suppliers that is already happening, and will encourage further CEHRT adoption. (83 FR 35990). We solicited comment on this proposal. The following is a summary of the public comments received in response to our request for comment and our responses: Comment: A few commenters supported increasing the CEHRT use criterion as of January 1, 2020, to 75 percent of participating eligible clinicians in each APM Entity. Response: We appreciate the support for our proposal to change the Other Payer Advanced APM CEHRT use criterion to 75 percent. Comment: Many commenters expressed concern with the proposed change to the current CEHRT use criterion stating that raising it to 75 percent of participating eligible clinicians in each APM Entity may be too burdensome. A few commenters noted that the CEHRT use criterion should not be increased by any amount. One commenter stated that the CEHRT use criterion should remain at 50 percent and allow APM entities to attest that APM participants are using health IT. Some commenters stated the increase is premature as the All-Payer Combination Option is beginning in 2019. Some commenters suggested that the increase in the threshold should occur over a longer period of time to accommodate multi-year cycles of APM contracts. Response: We do not believe that such an increase in the Other Payer Advanced APM minimum CEHRT use threshold will be burdensome for APM participants. According to data collected by ONC, certified EHR adoption has been widespread with over 3 in 4 officebased physicians adopted a certified EHR in CY 2015, and we want to VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 continue to encourage such adoption and use of CEHRT. Further, regarding the comments that the increase in the threshold should occur over a longer period of time to accommodate multiyear cycles of APM contracts, we remind the commenters that, although we proposed the same increase in the Advanced APM minimum CEHRT use threshold beginning January 1, 2019, the proposed increase for Other Payer Advanced APMs would not apply until January 1, 2020. We believe this is a sufficient amount of lead time, especially given the widespread adoption of EHRs. After considering public comments, we are finalizing our proposal to change the current CEHRT use criterion for Other Payer Advanced APMs so that in order to qualify as an Other Payer Advanced APM as of January 1, 2020, the other payer arrangement must require at least 75 percent of participating eligible clinicians in each APM Entity to use CEHRT. (iii) Evidence of CEHRT Use In the CY 2017 Quality Payment Program final rule, we adopted a CEHRT use criterion for Other Payer Advanced APMs that directly paralleled the CEHRT use criterion for Advanced APMs wherein Other Payer Advanced APMs must require at least 50 percent of eligible clinicians in each participating APM Entity, or each hospital if hospitals are the APM Entities, to use CEHRT to document and communicate clinical care. We have since heard from payers and other stakeholders that CEHRT is often used under other payer arrangements even if it is not expressly required under the payment arrangement. Because CEHRT use is increasingly common among eligible clinicians, payers may not believe it is necessary to specifically require the use of CEHRT under the terms of an Other Payer payment arrangement. Given this, we believe our current policy may needlessly exclude certain existing payment arrangements that could meet the statutory requirements for Other Payer Advanced APMs— including some where the majority of eligible clinicians use CEHRT, even if they are not explicitly required to do so under the terms of their payment arrangements. We proposed that a payer or eligible clinician must provide documentation to CMS that CEHRT is used to document and communicate clinical care under the payment arrangement by at least 50 percent of eligible clinicians in 2019, and 75 percent of the eligible clinicians in 2020 and beyond, whether or not PO 00000 Frm 00096 Fmt 4701 Sfmt 4700 such CEHRT use is explicitly required under the terms of the payment arrangement. We specifically proposed to modify the regulation at § 414.1420(b) to specify that to be an Other Payer Advanced APM, CEHRT must be used by at least 50 percent of eligible clinicians participating in the arrangement in 2019 (or, beginning in 2020, 75 percent) of such eligible clinicians). We solicited comment on this proposal. The following is a summary of the public comments received in response to our request for comment and our responses: Comment: Many commenters expressed support for CMS’ proposal that a payer or eligible clinician must provide documentation to CMS that CEHRT is used by at least 50 percent of eligible clinicians in 2019, and 75 percent of eligible clinicians in 2020 and beyond, whether or not such CEHRT use is explicitly required under the terms of the payment arrangement. Response: We appreciate the support for our proposal to allow for documentation that CEHRT is used at required levels by eligible clinicians. After considering public comments, we are finalizing our proposal that a payer or eligible clinician must provide documentation to CMS that CEHRT is used to document and communicate clinical care under the payment arrangement by at least 50 percent of eligible clinicians in 2019, and 75 percent of the eligible clinicians in 2020 and beyond, whether or not such CEHRT use is explicitly required under the terms of the payment arrangement. Specifically, we are finalizing our proposal to modify the regulation at § 414.1420(b) to specify that to be an Other Payer Advanced APM, CEHRT must be used by at least 50 percent of eligible clinicians participating in the arrangement in 2019 (or, beginning in 2020, 75 percent) of such eligible clinicians. (d) MIPS Comparable Quality Measures (i) Overview In the CY 2017 Quality Payment Program final rule, we explained that one of the criteria for a payment arrangement to be an Other Payer Advanced APM is that it must apply quality measures comparable to those under the MIPS quality performance category (81 FR 77465). In the CY 2017 Quality Payment Program proposed rule, we proposed that to be an Other Payer Advanced APM, a payment arrangement must have quality measures that are evidence- E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations amozie on DSK3GDR082PROD with RULES3 based, reliable, and valid; and that at least one measure must be an outcome measure if there is an applicable outcome measure on the MIPS quality measure list. We generally refer to these measures in the remainder of this discussion as ‘‘MIPS-comparable quality measures.’’ We did not specify in our regulation that the outcome measure is required to be evidence-based, reliable, and valid (81 FR 77466). We finalized these policies in the CY 2017 Quality Payment Program final rule and codified them in the regulation at § 414.1420(c). (ii) General Quality Measures: EvidenceBased, Reliable, and Valid In the CY 2017 Quality Payment Program final rule, we codified at § 414.1420(c)(2) that at least one of the quality measures used in the payment arrangement with an APM Entity must have an evidence-based focus, be reliable, and valid, and meet at least one of the following criteria: • Used in the MIPS quality performance category as described in § 414.1330; • Endorsed by a consensus-based entity; • Developed under section 1848(s) of the Act; • Submitted in response to the MIPS Call for Quality Measures under section 1848(q)(2)(D)(ii) of the Act; or • Any other quality measures that CMS determines to have an evidencebased focus and to be reliable and valid. It has come to our attention that, as with the comparable policy for Advanced APMs as discussed at 81 FR 28302, some have read the regulation at § 414.1420(c)(2) to mean that measures on the MIPS final list or submitted in response to the MIPS Call for Quality Measures necessarily are MIPS– comparable quality measures, even if they have not been determined to be evidence-based, reliable, and valid. We did not intend to imply that any measure that was merely submitted in response to the annual call for quality measures or developed using Quality Payment Program funding would automatically qualify as MIPScomparable regardless of whether the measure was endorsed by a consensusbased entity, adopted under MIPS, or otherwise determined to be evidencebased, reliable, and valid. While we believe such measures may be evidencebased, reliable, and valid, we did not intend to consider them so for purposes of § 414.1420(c)(2) without independent verification by a consensus-based entity or based on our own assessment and determination that they are evidencebased, reliable, and valid. We further believe the same principle applies to VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 QCDR measures. If QCDR measures are endorsed by a consensus-based entity they are presumptively considered MIPS-comparable quality measures for purposes of § 414.1420(c)(2); otherwise we would have needed independent verification, or to make our own assessment and determination, that the measures are evidence-based, reliable, and valid before considering them to be MIPS-comparable (see 81 FR 77415 through 77417). Because of the potential ambiguity in the existing definition and out of an abundance of caution in order to avoid any adverse impact on APM entities, eligible clinicians or other stakeholders, we have used the more permissive interpretation of the text, wherein measures developed under section 1848(s) of the Act and submitted in response to the MIPS Call for Quality Measures will meet the quality criterion in implementing the program thus far, and intend to use this interpretation for the 2019 QP Performance Period. Recognizing that APMs and other payer arrangements that we might consider for Advanced APM and Other Payer Advanced APM determinations are well into development for 2019, we proposed to use this interpretation until our new proposal described below is effective on January 1, 2020. Therefore, at § 414.1420(c)(2), we proposed, effective January 1, 2020, that at least one of the quality measures used in the payment arrangement with an APM Entity must meet at least one of the following criteria: • Finalized on the MIPS final list of measures, as described in § 414.1330; • Endorsed by a consensus-based entity; or • Otherwise determined by CMS to be evidenced-based, reliable, and valid. That is, for QP Performance Period 2020 and all future QP Performance Periods, we would treat any measure that is either included in the MIPS final list of measures or has been endorsed by a consensus-based entity as presumptively evidence-based, reliable, and valid. All other measures would need to be independently determined by CMS to be evidence-based, reliable, and valid, in order to be considered MIPScomparable quality measures. We solicited comment on this proposal. The following is a summary of the public comments received in response to our request for comment and our responses: Comment: A few commenters supported the proposal that at least one of the quality measures used in the payment arrangement with and APM Entity must meet at least one of the PO 00000 Frm 00097 Fmt 4701 Sfmt 4700 59931 three proposed criteria to assure that it is evidence-based, reliable, and valid. Response: We appreciate the support for our proposal. Comment: One commenter urged CMS to include a fourth way to determine a quality measure is ‘‘MIPSlike’’ by clarifying that all Medicare Advantage Star Rating measures are determined to be evidence-based, reliable, and valid by CMS. The commenter stated that these metrics were determined by CMS to be valid and reliable enough to use as a basis of MA plan payment. Response: We believe that all active Medicare Advantage Star Rating quality measures (https://www.cms.gov/ Medicare/Prescription-Drug-Coverage/ PrescriptionDrugCovGenIn/ PerformanceData.html) are evidencedbased, reliable, and valid when used at the health plan level. However, if a payer has changed the unit of analysis from applying it at the health plan level to using it at the provider level, as would likely be necessary in this context, this may have affected the reliability and validity of the measure. As such, we believe it is important that all such measures be independently determined by CMS to be evidencedbased, reliable, and valid in the context of their use in the payment arrangement in order to satisfy the Other Payer Advanced APM criterion. We would note that this determination that a quality measure is MIPS-comparable would be made using the information collected by CMS as part of the data submission process for Other Payer Advanced APM determinations. After considering public comments, we are finalizing our proposal to revise § 414.1420(c)(2) to clarify, effective as of January 1, 2020, that at least one of the quality measures used in the payment arrangement with an APM Entity must either be finalized on the MIPS final list of measures, as described in § 414.1330; endorsed by a consensus-based entity; or determined by CMS to be evidencedbased, reliable, and valid. (iii) Outcome Measures: EvidenceBased, Reliable, and Valid In § 414.1420(c)(3), we generally require that, to be an Other Payer Advanced APM, the payment arrangement must use an outcome measure if there is an applicable outcome measure on the MIPS quality measure list. We note that the current regulation does not require that the outcome measure be evidence-based, reliable, and valid. We proposed to revise § 414.1420(c)(3), to explicitly require that, unless there is no applicable E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59932 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations outcome measure on the MIPS quality measure list, at least one outcome measure that is used in the payment arrangement must be evidence-based, reliable, and valid. This proposal would have an effective date of January 1, 2020, and would specifically require that an outcome measure must also be MIPS-comparable. This proposal aligns with the similar proposal for Advanced APMs discussed at section III.I.4.e.(3)(d)(ii) of this final rule, so that an outcome measure used in the payment arrangement must also be: • Finalized on the MIPS final list of measures, as described in § 414.1330; • Endorsed by a consensus-based entity; or • Determined by CMS to be evidencebased, reliable, and valid. The proposal would have an effective date of January 1, 2020. This proposed effective date is intended to provide stakeholders sufficient notice of, and opportunity to respond to, this change in our regulation because the current regulation does not explicitly require that an outcomes measures must be evidence-based, reliable, and valid and, as a result some Other Payer Advanced APMs that were submitted for determination in CY 2018 for the CY 2019 performance year may not include outcomes measures that are evidencebased, reliable, and valid. We also proposed that, for such payment arrangements that are determined to be Other Payer Advanced APMs for the 2019 performance year and did not include an outcome measure that is evidence-based, reliable, and valid, and that are resubmitted for an Other Payer Advanced APM determination for the 2020 performance year (whether for a single year, or for a multi-year determination as proposed in section III.I.4.e.(4)(b) of this final rule), we will continue to apply the current regulation for purposes of those determinations. Additionally, payment arrangements in existence prior to the 2020 performance year that are submitted for determination to be Other Payer Advanced APMs for the 2020 performance year and later, will be assessed under the rules of the current regulation meaning they do not need to include an outcome measure that is evidence-based, reliable, and valid to be an Other Payer Advanced APM. For all other payment arrangements the proposed revised regulation would apply beginning in CY 2020. We solicited comment on this proposal. The following is a summary of the public comments received in response to our request for comment and our responses: VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 Comment: One commenter supported the proposal that at least one outcome measure must be among the quality measures used in the payment arrangement with an APM Entity, and that the outcome measure must meet at least one of the three proposed criteria to assure that it is evidence-based, reliable, and valid. Response: We appreciate the support for our proposal. After considering public comments, we are finalizing our proposal to revise § 414.1420(c)(3), effective January 1, 2020, to explicitly require that, unless there is no applicable outcome measure on the MIPS quality measure list, at least one outcome measure that applies in the payment arrangement must either be finalized on the MIPS final list of measures as described in § 414.1330, endorsed by a consensus-based entity, or determined by CMS to be evidencebased, reliable, and valid. (e) Financial Risk for Monetary Losses (i) Overview In the CY 2018 Quality Payment Program final rule, we finalized our proposal to add a revenue-based nominal amount standard to the generally applicable nominal amount standard for Other Payer Advanced APMs that is parallel to the generally applicable revenue-based nominal amount standard for Advanced APMs. Specifically, we finalized that an other payer arrangement would meet the total risk component of the proposed nominal risk standard if, under the terms of the other payer arrangement, the total amount that an APM Entity potentially owes the payer or foregoes is equal to at least: For the 2019 and 2020 QP Performance Periods, 8 percent of the total combined revenues from the payer of providers and suppliers in participating APM Entities. This standard is in addition to the previously finalized expenditure-based standard. We explained that a payment arrangement would only need to meet one of the two standards. We would use this standard only for other payer arrangements where financial risk is expressly defined in terms of revenue in the payment arrangement. (ii) Generally Applicable Nominal Amount Standard We proposed to amend § 414.1420(d)(3)(i) to maintain the generally applicable revenue-based nominal amount standard at 8 percent of the total combined revenues from the payer of providers and suppliers in participating APM Entities for QP Performance Periods 2019 through 2024. PO 00000 Frm 00098 Fmt 4701 Sfmt 4700 This change is consistent with the proposed amendment to our regulation to maintain the generally applicable revenue-based nominal standard at 8 percent for Advanced APMs during the same timeframe. We solicited comment on this proposal. The following is a summary of the public comments received in response to our request for comment and our responses: Comment: Commenters expressed support for the proposal to maintain the general applicable revenue-based nominal amount standard at 8 percent for QP Performance Periods 2021 through 2024. Response: We appreciate the support for our proposal to maintain the generally applicable revenue-based nominal amount standard. After considering public comments, we are finalizing our proposal to revise § 414.1420(d)(3)(i) to maintain the generally applicable revenue-based nominal amount standard at 8 percent of the total combined revenues from the payer of providers and suppliers in participating APM Entities for QP Performance Periods 2021 through 2024. (4) Determination of Other Payer Advanced APMs (a) Overview In the CY 2017 Quality Payment Program final rule, we specified that an APM Entity or eligible clinician must submit, by a date and in a manner determined by us, information necessary to identify whether a given payment arrangement satisfies the Other Payer Advanced APM criteria (81 FR 77480). In the CY 2018 Quality Payment Program final rule, we codified at § 414.1445 the Payer Initiated Other Payer Advanced APM Determination Process and the Eligible Clinician Initiated Other Payer Advanced APM Determination Process pertaining to the determination of Other Payer Advanced APMs, as well as specifying the information required for Other Payer Advanced APM determinations (82 FR 53814 through 53873). (b) Multi-Year Other Payer Advanced APM Determinations In the CY 2018 Quality Payment Program final rule, we finalized that Other Payer Advanced APM determinations made in response to requests submitted either through the Payer Initiated Other Payer Advanced APM Determination Process (Payer Initiated Process) or the Eligible Clinician Initiated Other Payer E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations Advanced APM Determination Process (Eligible Clinician Initiated Process) would be in effect for only one year at a time. We sought additional comment regarding the current duration of payment arrangements and whether creating a multi-year determination process would encourage the creation of more multi-year payment arrangements as opposed to payment arrangements that are for one year only. We also sought comment on what kind of information should be submitted annually after the first year to update an Other Payer Advanced APM determination (82 FR 53869 through 53870). After consideration of this feedback, we proposed to maintain the annual submission process with the modifications outlined below for both the Payer Initiated Process and the Eligible Clinician Initiated Process. We proposed that beginning with the 2019 and 2020 submission periods for Other Payer Advanced APM determinations for performance year 2020, after the first year that a payer, APM Entity, or eligible clinician (which we refer to as the ‘‘requester’’ in the remainder of this discussion) submits a multi-year payment arrangement that we determine to be an Other Payer Advanced APM for that year, the requester would need to submit information only on changes to the payment arrangement that are relevant to the Other Payer Advanced APM criteria for each successive year for the remaining duration of the payment arrangement. In the initial submission, the requester would certify as usual that the information provided about the payment arrangement using the Payer Initiated Process or Eligible Clinician Initiated Process, as applicable, is true, accurate, and complete; would authorize CMS to verify the information; and would certify that they would submit revised information in the event of a material change to the payment arrangement. For multi-year payment arrangements, we proposed to require as part of the submission that the certifying official for the requester must agree to review the submission at least once annually, to assess whether there have been any changes to the information since it was submitted, and to submit updated information notifying us of any changes to the payment arrangement that would be relevant to the Other Payer Advanced APM criteria, and thus, to our determination of the arrangement to be an Other Payer Advanced APM, for each successive year of the arrangement. Absent the submission by the requester of updated information to reflect VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 changes to the payment arrangement, we would continue to apply the original Other Payer Advanced APM determination for each successive year through the earlier of the end of that multi-year payment arrangement or 5 years. We solicited comment on this proposal. The following is a summary of the public comments received in response to our request for comment and our responses: Comment: Many commenters supported the proposal that the requester would need to submit information only on any changes to the payment arrangement that are relevant to the Other Payer Advanced APM criteria for each successive year for the remaining duration of the payment arrangement. Response: We appreciate the support for our proposal to allow for multi-year submissions of payment arrangements. After considering public comments, we are finalizing our proposal to maintain the annual submission process with the modifications outlined above for both the Payer Initiated Process and the Eligible Clinician Initiated Process. For multi-year payment arrangements, we proposed to require as part of the submission that the certifying official for the requester must agree to review the submission at least once annually, to assess whether there have been any changes to the information since it was submitted, and to submit updated information notifying us of any changes to the payment arrangement that would be relevant to the Other Payer Advanced APM criteria, and thus, to our determination of the arrangement to be an Other Payer Advanced APM, for each successive year of the arrangement. Absent the submission by the requester of updated information to reflect changes to the payment arrangement, we would continue to apply the original Other Payer Advanced APM determination for each successive year through the earlier of the end of that multi-year payment arrangement or 5 years. We solicited comment on this proposal. The following is a summary of the public comments received in response to our request for comment and our responses: Comment: Many commenters supported our proposal to require as part of the submission that the certifying official for the requester must agree to review the submission at least once annually, to assess whether there have been any changes to the information since it was submitted, and to submit PO 00000 Frm 00099 Fmt 4701 Sfmt 4700 59933 updated information notifying us of any changes to the payment arrangement that would be relevant to the Other Payer Advanced APM criteria, and thus, to our determination of the arrangement to be an Other Payer Advanced APM, for each successive year of the arrangement. Commenters supported the proposal that this process remain in place through the earlier of the end of the multi-payment arrangement or 5 years. Response: We appreciate the support for our proposal. After considering public comments, we are finalizing our proposal to require as part of the submission that the certifying official for the requester must agree to review the submission at least once annually, to assess whether there have been any changes to the information since it was submitted, and to submit updated information notifying us of any changes to the payment arrangement that would be relevant to the Other Payer Advanced APM criteria, and thus, to our determination of the arrangement to be an Other Payer Advanced APM, for each successive year of the arrangement. Absent the submission by the requester of updated information to reflect changes to the payment arrangement, we will continue to apply the original Other Payer Advanced APM determination for each successive year through the earlier of the end of that multi-year payment arrangement or 5 years. (c) Payer Initiated Other Payer Advanced APM Determination Process (Payer Initiated Process)—Remaining Other Payers In the CY 2018 Quality Payment Program final rule, we finalized that we will allow certain other payers, including payers with payment arrangements authorized under Title XIX, Medicare Health Plan payment arrangements (Medicare Advantage plans, section 1876 cost plans PACE organization operated under section 1894 of the Act, and similar plans, other than an APM under section 1833(z)(3)(C) of the Act, that provide Medicare benefits under demonstration or waiver authority), and payers with payment arrangements aligned with a CMS Multi-Payer Model to use the Payer Initiated Process to request that we determine whether their other payer arrangements are Other Payer Advanced APMs starting prior to the 2019 QP Performance Period and each year thereafter (82 FR 53854). We codified this policy at § 414.1445(b)(1). We also finalized that the Remaining Other Payers, including commercial and other private payers, may request that E:\FR\FM\23NOR3.SGM 23NOR3 59934 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations amozie on DSK3GDR082PROD with RULES3 we determine whether other payer arrangements are Other Payer Advanced APMs starting prior to the 2020 QP Performance Period and each year thereafter (82 FR 53867). In the CY 2019 PFS proposed rule, we proposed details regarding the Payer Initiated Process for the Remaining Other Payers that were not among those other payers permitted to use the Payer Initiated Process to submit their arrangements for Other Payer Advanced APM Determinations in 2018 (Remaining Other Payers). To the extent possible, we are aligning the Payer Initiated Process for Remaining Other Payers with the previously finalized Payer Initiated Process for Medicaid, Medicare Health Plans, and CMS MultiPayer Models. In the CY 2018 Quality Payment Program final rule, we finalized that the Payer Initiated Process will be voluntary for all payers (82 FR 53855). We note that the Payer Initiated Process will be similarly voluntary for payers that were permitted to submit payment arrangements in 2018 and for Remaining Other Payers starting in 2019. Guidance and Submission Form: As we have for the other payers included in the Payer Initiated Process (82 FR 53874), we intend to make guidance available regarding the Payer Initiated Process for Remaining Other Payers prior to their first Submission Period, which will occur during 2019. We intend to modify the submission form (which we refer to as the Payer Initiated Submission Form) for use by Remaining Other Payers to request Other Payer Advanced APM determinations, and to make this Payer Initiated Submission Form available to Remaining Other Payers prior to the first Submission Period. We proposed that a Remaining Other Payer will be required to use the Payer Initiated Submission Form to request that we make an Other Payer VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 Advanced APM determination. We intend for the Payer Initiated Submission Form to include questions that are applicable to all payment arrangements and some questions that are specific to a particular type of payment arrangement, and we intend for it to include a way for payers to attach supporting documentation. We solicited comment on this proposal. The following is a summary of the public comments received in response to our request for comment and our responses: Comment: Commenters supported the proposal to require Remaining Other Payers to use the Payer Initiated Submission Form to request that CMS make an Other Payer Advanced APM determination. Response: We appreciate the support for our proposal. After considering public comments, we are finalizing our proposal that Remaining Other Payers will use the Payer Initiated Submission Form to request that CMS make an Other Payer Advanced APM determination. We proposed that Remaining Other Payers may submit requests for review of multiple other payer arrangements through the Payer Initiated Process, though we would make separate determinations as to each other payer arrangement and a payer would be required to use a separate Payer Initiated Submission Form for each other payer arrangement. Remaining Other Payers may submit other payer arrangements with different tracks within that arrangement as one request along with information specific to each track. We solicited comment on this proposal. We did not receive any comment in response to this proposal. PO 00000 Frm 00100 Fmt 4701 Sfmt 4700 We are finalizing our proposal that Remaining Other Payers may submit requests for review of multiple other payer arrangements through the Payer Initiated Process, though we would make separate determinations as to each other payer arrangement and a payer would be required to use a separate Payer Initiated Submission Form for each other payer arrangement. Submission Period: We proposed that the Submission Period for the Payer Initiated Process for use by Remaining Other Payers to request Other Payer Advanced APM determinations will open on January 1 of the calendar year prior to the relevant QP Performance Period for which we would make Other Payer Advanced APM determinations. We solicited comment on this proposal. The following is a summary of the public comments received in response to our request for comment and our responses: Comment: One commenter supported the CMS proposal that the Payer Initiated Process for use by Remaining Other Payers to request Other Payer Advanced APM determinations would open on January 1. Response: We appreciate the support for our proposal. After considering public comments, we are finalizing our proposal that the Payer Initiated Process for use by Remaining Other Payers to request Other Payer Advanced APM determinations would open on January 1. The finalized timeline for the Payer Initiated Process for Remaining Other Payers as well as the previously finalized timeline for the Payer Initiated Process for Medicaid and Medicare Health Plans, is summarized in Table 59 alongside the final timeline for the Eligible Clinician Initiated Process. E:\FR\FM\23NOR3.SGM 23NOR3 CMS Determination: Upon the timely receipt of a Payer Initiated Submission Form, we will use the information submitted to determine whether the other payer arrangement meets the Other Payer Advanced APM criteria. We proposed that if we find that the Remaining Other Payer has submitted incomplete or inadequate information, we will inform the payer and allow them to submit additional information no later than 15 business days from the date we inform the payer of the need for additional information. For each other payer arrangement for which the Remaining Other Payer does not submit sufficient information in a timely fashion, we will not make a determination in response to that request submitted via the Payer Initiated Submission Form. As a result, the other payer arrangement will not be considered an Other Payer Advanced APM for the year. These determinations are final and not subject to reconsideration. We solicited comment on this proposal. We did not receive any comments in response to this proposal. We are finalizing our proposal that if we find that the Remaining Other Payer has submitted incomplete or inadequate information, we would inform the payer VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 and allow them to submit additional information no later than 15 business days from the date we inform the payer of the need for additional information. CMS Notification: We intend to notify Remaining Other Payers of our determination for each request as soon as practicable after the relevant Submission Deadline. We note that Remaining Other Payers may submit information regarding an other payer arrangement for a subsequent QP Performance Period even if we have determined that the other payer arrangement is not an Other Payer Advanced APM for a prior year. CMS Posting of Other Payer Advanced APMs: We intend to post on the CMS website a list (which we refer to as the Other Payer Advanced APM List) of all other payer arrangements that we determine to be Other Payer Advanced APMs. Prior to the start of the relevant QP Performance Period, we intend to post a list of the payment arrangements that we determine to be Other Payer Advanced APMs through the Payer Initiated Process, and Other Payer Advanced APMs under Title XIX through the Eligible Clinician Initiated Process. After the QP Performance Period, we will update this list to include payment arrangements that we determine to be Other Payer Advanced PO 00000 Frm 00101 Fmt 4701 Sfmt 4700 59935 APMs based on other requests through the Eligible Clinician Initiated Process. We intend to post the list of other payer arrangements that we determine to be Other Payer Advanced APMs through the Payer Initiated Process prior to the start of the relevant QP Performance Period, and then to update the list to include payment arrangements that we determine to be Other Payer Advanced APMs based on requests received through the Eligible Clinician Initiated Process. (d) Payer Initiated Process—CMS MultiPayer Models In the CY 2018 Quality Payment Program final rule, we finalized that beginning for the first QP Performance Period under the All-Payer Combination Option, payers with a payment arrangement aligned with a CMS MultiPayer Model may request that we determine whether that aligned payment arrangement is an Other Payer Advanced APM. In the CY 2019 PFS proposed rule, we proposed to eliminate the Payer Initiated Process and submission form that are specifically for CMS MultiPayer Models. We believe that payers aligned with CMS Multi-Payer Models can submit their arrangements through the Payer Initiated Process for E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.076</GPH> amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 59936 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations Remaining Other Payers we have proposed in section III.I.4.g.(3)(c) of this final rule, or through the existing Medicaid or Medicare Health Plan payment arrangement submission process, as applicable. We solicited comment on this proposal. We did not receive any comment in response to this proposal. We are finalizing our proposal to eliminate the Payer Initiated Process and submission form that are specifically for CMS Multi-Payer Models. (5) Calculation of All-Payer Combination Option Threshold Scores and QP Determinations (a) Overview In the CY 2017 Quality Payment Program final rule, we finalized our overall approach to the All-Payer Combination Option (81 FR 77463). Beginning in 2021, in addition to the Medicare Option, an eligible clinician may alternatively become a QP through the All-Payer Combination Option, and an eligible clinician need only meet the QP threshold under one of the two options to be a QP for the payment year (81 FR 77459). We finalized that we will conduct the QP determination sequentially so that the Medicare Option is applied before the All-Payer Combination Option (81 FR 77459). In the CY 2017 Quality Payment Program final rule, we finalized that we will calculate Threshold Scores under the Medicare Option through both the payment amount and the patient count methods, compare each Threshold Score to the relevant QP and Partial QP Thresholds, and use the most advantageous scores to make QP determinations (81 FR 77457). We finalized the same approach for the AllPayer Combination Option wherein we will use the most advantageous method for QP determinations with the data that has been provided (81 FR 77475). amozie on DSK3GDR082PROD with RULES3 (b) QP Determinations Under the AllPayer Combination Option In the CY 2018 Quality Payment Program final rule, we finalized that an eligible clinician may request a QP determination at the eligible clinician level, and that an APM Entity may request a QP determination at the APM Entity Level (82 FR 53880 through 53881). In the event that we receive a request for QP determination from an individual eligible clinician and also separately from that individual eligible clinician’s APM Entity, we would make a determination at both levels. The eligible clinician could become a QP on VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 the basis of either of the two determinations (82 FR 53881). We proposed to add a third alternative to allow requests for QP determinations at the TIN level in instances where all clinicians who have reassigned billing rights under the TIN participate in a single (meaning the same) APM Entity. Therefore, this option would be available to all TINs participating in Full TIN APMs, such as the Medicare Shared Savings Program. It would also be available to any other TIN for which all clinicians who have reassigned their billing rights to the TIN are participating in the same APM Entity. We solicited comment on this proposal. The following is a summary of the public comments received in response to our request for comment and our responses: Comment: Many commenters supported the proposal to add a third alternative to allow requests for QP determinations at the TIN level in instances where all clinicians who have reassigned billing rights under the TIN participate in a single APM Entity. Response: We appreciate the support for our proposal. After considering public comments, we are finalizing our proposal to add a third alternative to allow requests for QP determinations at the TIN level in instances where all clinicians who have reassigned billing rights under the TIN participate in a single APM Entity. We proposed that, similar to our existing policies for individual and APM Entity requests for QP determinations under the All-Payer Combination Option, we would assess QP status based on the most advantageous result for each individual eligible clinician. That is, if we receive any combination of QP determination requests (at the TIN-level, APM Entity level, or individual level) we will make QP assessments at all requested levels and determine QP status on the basis of the QP assessment that is most advantageous to the eligible clinician. We solicited comment on this proposal. The following is a summary of the public comments received in response to our request for comment and our responses: Comment: Many commenters supported the proposal to assess QP status based on the most advantageous result for each individual eligible clinician. Response: We appreciate the support for our proposal. After considering public comments, we are finalizing our proposal to assess PO 00000 Frm 00102 Fmt 4701 Sfmt 4700 QP status based on the most advantageous result for each individual eligible clinician. (c) Use of Individual or APM Entity Information for Medicare Payment Amount and Patient Count Calculation Under the All-Payer Combination Option (i) Flexibility in the Medicare Option and All-Payer Combination Option Threshold Methods In the CY 2018 Quality Payment Program final rule, we finalized that when we make QP determinations at the individual eligible clinician level, we would use the individual eligible clinician payment amounts and patient counts for the Medicare calculations in the All-Payer Combination Option. When we make QP determinations at the APM Entity level, we will use APM Entity level payment amounts and patient counts for the Medicare calculations in QP determinations under the All-Payer Combination Option. Eligible clinicians assessed at the individual eligible clinician level under the Medicare Option at § 414.1425(b)(2) will be assessed at the individual eligible clinician level only under the All-Payer Combination Option. We codified these policies at § 414.1440(d)(2) (82 FR 53881). We noted in the CY 2019 PFS proposed rule that some may have read our regulation at § 414.1440(d)(2) to suggest that consistency is required across the two thresholds requiring eligible clinicians or APM Entities to meet the minimum Medicare threshold needed to qualify for the All-Payer Combination Option and the All-Payer threshold using the same method— either payment amounts or patient counts. Although we did not directly address this specific question in our current regulation or in prior rulemaking, we are clarifying that eligible clinicians or APM Entities can meet the minimum Medicare threshold for the All-Payer Combination option using one method (whichever is most favorable), and the All-Payer threshold for the All-Payer Combination Option using either the same, or the other method. All data submitted to us for Other Payer Advanced APM determinations and, when applicable, QP determinations using the All-Payer Combination Option will be considered and evaluated; and eligible clinicians (or APM Entities or TINs, as appropriate) may submit all data relating to both the payment amount and patient count methods. To avoid any potential ambiguity for the future, we proposed a change to § 414.1440(d) E:\FR\FM\23NOR3.SGM 23NOR3 59937 Comment: Some commenters supported the proposal to allow eligible clinicians or APM Entities to meet the minimum Medicare threshold using the most favorable of the payment amount or patient count method, and then to meet the All-Payer threshold using either the same method or the other method. Response: We appreciate the support for our proposal. After considering public comments, we are finalizing our proposal with the correction noted above, that we are amending the text in our regulation at § 414.1440(d)(1) to expressly allow eligible clinicians or APM Entities to meet the minimum Medicare threshold using the most favorable of the payment amount or patient count method, and then to meet the All-Payer threshold using either the same method or the other method. In the CY 2019 PFS proposed rule, we proposed to extend the same weighting methodology to TIN level Medicare Threshold Scores in situations where a TIN is assessed under the Medicare Option as part of an APM Entity group, and receives a Medicare Threshold Score at the APM Entity group level. In this scenario, we believe that the Medicare portion of the TIN’s All-Payer Combination Option Threshold Score should not be lower than the Medicare Threshold Score that they received by participating in an APM Entity group (82 FR 53881–53882). We note this extension of the weighting methodology would only apply to a TIN when that TIN represents a subset of the eligible clinicians in the APM Entity, because when the TIN and the APM Entity are the same there is no need for this weighted methodology. We would multiply the TIN’s APM Entity group Medicare Threshold Score by the total Medicare payments or patients for that TIN as follows: We proposed to calculate the TIN’s Threshold Scores both on its own and with this weighted methodology, and then use the most advantageous score when making a QP determination. We believe that, as it does for QP determinations made at the APM Entity level, this approach promotes consistency between the Medicare Option and the All-Payer Combination Option to the extent possible. Additionally, the proposed application of this weighting approach in the case of a TIN level QP determination would be consistent with our established policy. We solicited comment on this proposal. The following is a summary of the public comments received in response to our request for comment and our responses: Comment: Commenters supported the proposal to extend the same weighting VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 (ii) Extending the Medicare Threshold Score Weighting Methodology to TIN Level All-Payer Combination Option Threshold Score Calculations In the CY 2018 Quality Payment Program final rule, we explained that we recognize that in many cases an individual eligible clinician’s Medicare Threshold Scores would likely differ from the corresponding Threshold Scores calculated at the APM Entity group level, which would benefit those eligible clinicians whose individual Threshold Scores would be higher than the group Threshold Scores and disadvantage those eligible clinicians PO 00000 Frm 00103 Fmt 4701 Sfmt 4700 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.288</GPH> whose individual Threshold Scores are equal to or lower than the group Threshold Scores (82 FR 53881–53882). In situations where eligible clinicians are assessed under the Medicare Option as an APM Entity group, and receive a Medicare Threshold Score at the APM Entity group level, we believe that the Medicare portion of their All-Payer calculation under the All-Payer Combination Option should not be lower than the Medicare Threshold Score that they received by participating in an APM Entity group. To accomplish this outcome, we finalized a modified weighting methodology. We finalized that when the eligible clinician’s Medicare Threshold Score calculated at the individual level would be lower than the Medicare Threshold Score calculated at the APM Entity group level, we would apply a weighting methodology to calculate the Threshold Score for the eligible clinician. This methodology allows us to apply the APM Entity group level Medicare Threshold Score (if higher than the individual eligible clinician level Medicare Threshold Score), to the eligible clinician, under either the payment amount or patient count method, but weighted to reflect the individual eligible clinician’s Medicare volume. We multiply the eligible clinician’s APM Entity group Medicare Threshold Score by the total Medicare payments or patients made to that eligible clinician as follows: to codify this clarification. We proposed to add a new § 414.1440(d)(4) to expressly allow eligible clinicians or APM Entities to meet the minimum Medicare threshold using the most favorable of the payment amount or patient count method, and then to meet the All-Payer threshold using either the same method or the other method. We note that, in the preamble in the CY 2019 PFS proposed rule, we indicated that we would codify this proposed policy by adding a new § 414.1440(d)(4) to our regulations. However, the corresponding proposed regulation text included the proposed policy as an amendment to the regulation text at § 414.1440(d)(1). We intended to propose the policy reflected in the propoed regulation text, and due to a clerical error, inadvertently neglected to revise the description of the proposal in the preamble. As such, rather than adding a new § 414.1440(d)(4), we intended to propose to amend the regulation at § 414.1440(d)(1) to expressly allow eligible clinicians or APM Entities to meet the minimum Medicare threshold using the most favorable of the payment amount or patient count method, and then to meet the All-Payer threshold using either the same method or the other method. We solicited comment on this proposal. The following is a summary of the public comments received in response to our request for comment and our responses: ER23NO18.077</GPH> amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 59938 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations amozie on DSK3GDR082PROD with RULES3 methodology to TIN level Medicare Threshold Scores in situations where a TIN is assessed under the Medicare Option as part of an APM Entity group, and receives a Medicare Threshold Score at the APM Entity group level. Response: We appreciate support for our proposal. After considering public comments, we are finalizing our proposal to extend the same weighting methodology to TIN level Medicare Threshold Scores in situations where a TIN is assessed under the Medicare Option as part of an APM Entity group, and receives a Medicare Threshold Score at the APM Entity group level. (6) Summary of Final Policies In this section, we are finalizing the following policies: Other Payer Advanced APM Criteria: • We are finalizing our proposal to change the CEHRT use criterion so that in order to qualify as an Other Payer Advanced APM as of January 1, 2020, the percentage of eligible clinicians participating in the other payer arrangement who are using CEHRT must be 75 percent. • We are finalizing our proposal to allow payers and eligible clinicians to submit evidence as part of their request for an Other Payer Advanced APM determination that CEHRT is used by the requisite percentage of eligible clinicians participating in the payment arrangement (50 percent for 2019, and 75 percent for 2020 and beyond) to document and communicate clinical care, whether or not CEHRT use is explicitly required under the terms of the payment arrangement. We codifying this change at § 414.1420(b). • We are finalizing the following clarification to § 414.1420(c)(2), effective January 1, 2020, to provide that at least one of the quality measures used in the payment arrangement in paragraph (c)(1) of this regulation must be: ++ Finalized on the MIPS final list of measures, as described in § 414.1330; ++ Endorsed by a consensus-based entity; or ++ Determined by CMS to be evidenced-based, reliable, and valid. • We are finalizing our proposal to revise § 414.1420(c)(3) to require that, effective January 1, 2020, unless there is no applicable outcome measure on the MIPS quality measure list, an Other Payer Advanced APM must use an outcome measure, that meets the proposed criteria in paragraph (c)(2) of this regulation. • We are also finalizing our proposal at § 414.1420(c)(3)(i) that, for payment arrangements determined to be Other VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 Payer Advanced APMs for the 2019 performance year which did not include an outcome measure that is evidencebased, reliable, and valid, that are resubmitted for an Other Payer Advanced APM determination for the 2020 performance year (whether for a single year, or for a multi-year determination as proposed in section III.I.4.g.(3)(b) of this final rule), we would continue to apply the current regulation for purposes of those determinations. This revision also applies to payment arrangements in existence prior to the 2020 performance year that are submitted for determination to be Other Payer Advanced APMs for the 2020 performance year and later. Determination of Other Payer Advanced APMs • We are finalizing details regarding the Payer Initiated Process for Remaining Other Payers. To the extent possible, we are aligning the Payer Initiated Process for Remaining Other Payers with the previously finalized Payer Initiated Process for Medicaid, Medicare Health Plans, and CMS MultiPayer Models. • We are finalizing our proposal to eliminate the Payer Initiated Process that is specifically for CMS Multi-Payer Models. We believe that payers aligned with CMS Multi-Payer Models can submit their arrangements through the Payer Initiated Process for Remaining Other Payers that we are finalizing as described in section III.I.4.g.(3)(c) of this final rule, or through the Medicaid or Medicare Health Plan payment arrangement submission processes. Calculation of All-Payer Combination Option Threshold Scores and QP Determinations • We are finalizing our proposal to add a third alternative to allow requests for QP determinations at the TIN level in instances where all clinicians who reassigned billing rights under the TIN participate in a single APM Entity. We are finalizing this proposal to revise § 414.1440(d), by adding this third alternative to allow QP determinations at the TIN level in instances where all clinicians who have reassigned billing under the TIN participate in a single APM Entity, as well as to assess QP status at the most advantageous level for each eligible clinician. • We also are finalizing our clarification that, in making QP determinations using the All-Payer Combination Option, eligible clinicians may meet the minimum Medicare threshold using one method, and the All-Payer threshold using the same or a PO 00000 Frm 00104 Fmt 4701 Sfmt 4700 different method. We are finalizing our proposal with a correction to codify this clarification by amending § 414.1440(d)(1). • We are finalizing our proposal to extend the same weighting methodology to TIN level Medicare Threshold Scores in situations where a TIN is assessed under the Medicare Option as part of an APM Entity group, and receives a Medicare Threshold Score at the APM Entity group level. 5. Quality Payment Program Technical Correction: Regulation Text Changes a. Overview We proposed certain technical revisions to our regulations in order to correct several technical errors and to reconcile the text of several of our regulations with the final policies we adopted through notice and comment rulemaking. b. Regulation Text Changes We proposed a technical correction to § 414.1415(b)(1) of our regulations to specify that an Advanced APM must require quality measure performance as a factor when determining payment to participants for covered professional services under the terms of the APM (83 FR 36005). The addition of the word ‘‘quality’’ better aligns with section 1833(z)(3)(D) of the Act and with the policy that was finalized in the CY 2017 Quality Payment Program final rule (81 FR 77406), and corrects a clerical error we made in the course of revising the text of § 414.1415(b)(1) for inclusion in the CY 2017 QPP final rule. This proposed revision would not change our current policy for this Advanced APM criterion. We solicited comment on this proposal. We did not receive any comments in response to this proposal. We are finalizing the technical correction to § 414.1415(b)(1) to specify that an Advanced APM must require quality measure performance as a factor when determining payment to participants for covered professional services under the terms of the APM. We also proposed technical corrections to § 414.1420(d)(3)(ii)(B) (83 FR 36005). These changes align with the generally applicable nominal amount standard for Other Payer Advanced APMs that was finalized in the CY 2017 Quality Payment Program final rule, and the change to the generally applicable nominal amount standard in the CY 2018 Quality Payment Program final rule where we established a revenuebased nominal amount standard as part of the Other Payer Advanced APM E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations criteria (82 FR 53849–53850). We finalized that a payment arrangement must require APM Entities to bear financial risk for at least 3 percent of the expected expenditures for which an APM Entity is responsible under the payment arrangement, and that a payment arrangement’s level of marginal risk must be at least 30 percent of losses in excess of the expected expenditures, and the maximum allowable minimum loss rate must be 4 percent (81 FR 77471). Due to a clerical oversight, we inadvertently published two conflicting provisions in regulation text. At § 414.1420(d)(3)(i), we correctly finalized that a payment arrangement must require APM Entities to bear financial risk for at least 3 percent of the expected expenditures for which an APM Entity is responsible under the payment arrangement, and at § 414.1420(d)(3)(ii)(B) we incorrectly finalized that the risk arrangement must have a total potential risk of at least 4 percent of expected expenditures. We are effectuating this change by removing the Other Payer Advanced APM Criteria, Financial Risk, Generally Applicable Nominal Amount Standard provision at § 414.1420(d)(3)(ii)(B) and consolidating § 414.1420(d)(3)(ii)(A) into § 414.1420(d)(3)(ii). We solicited comment on this proposal. The following is a summary of the public comments received in response to our request for comment and our responses: Comment: One commenter thanked the agency for making the technical correction to clarify that an Other Payer payment arrangement must require APM Entities to bear financial risk for at least 3 percent, not 4 percent. Response: We thank the commenter for their support of this technical correction. After considering public comments, we are finalizing this technical correction by removing the Other Payer Advanced APM Criteria, Financial Risk, Generally Applicable Nominal Amount Standard provision at § 414.1420(d)(3)(ii)(B) and consolidating § 414.1420(d)(3)(ii)(A) into § 414.1420(d)(3)(ii). In the CY 2017 Quality Payment Program final rule, we finalized a capitation standard for the financial risk criterion under the Advanced APM Criteria and the Other Payer Advanced APM Criteria, respectively. We finalized that full capitation arrangements would meet the Advanced APM financial risk criterion and Other Payer Advanced APM financial risk criterion, and would not separately need to meet the generally applicable financial risk VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 standard and generally applicable nominal amount standard in order to satisfy the financial risk criterion for Advanced APMs and Other Payer Advanced APMs (81 FR 77431; 77472). We proposed to clarify the application of the capitation standard by revising § 414.1415(c) and § 414.1420(d) to refer to the full capitation exception that is expressed in paragraphs (c)(6) and (d)(7), respectively (83 FR 36006). We solicited comment on this proposal. We did not receive any comments in response to this proposal. We are finalizing our proposal to clarify the application of the capitation standard by revising § 414.1415(c) and § 414.1420(d) to refer to the full capitation exception that is expressed in paragraphs (c)(6) and (d)(7), respectively. In finalizing §§ 414.1415(c)(6) and 414.1420(d)(7), we specified that a capitation arrangement means a payment arrangement in which a per capita or otherwise predetermined payment is made under the APM for all items and services for which payment is made through the APM furnished to a population of beneficiaries, and no settlement is performed to reconcile or share losses incurred or savings earned by the APM Entity. This language does not completely reflect our definition of capitation risk arrangements as discussed in the preamble at 81 FR 77430 where we state that, ‘‘capitation risk arrangements, as defined here, involve full risk for the population of beneficiaries covered by the arrangement, recognizing that it might require no services whatsoever or could require exponentially more services than were expected in calculating the capitation rate. . . . [a] capitation risk arrangement adheres to the idea of a global budget for all items and services to a population of beneficiaries during a fixed period of time.’’ Therefore, we proposed to revise these regulations to align the Advanced APM Criteria, Financial Risk, Capitation provision at § 414.1415(c)(6), and the Other Payer Advanced APM Criteria, Financial Risk, Capitation provision at § 414.1420(d)(7) with the definition of capitation risk arrangements that we expressed in the preamble of the CY 2017 Quality Payment Program final rule at 81 FR 77430–77431 (83 FR 36006). We solicited comment on this proposal. We did not receive any comments in response to this proposal. We are finalizing our proposal to revise the Advanced APM Criteria, Financial Risk, Capitation provision at § 414.1415(c)(6), and the Other Payer PO 00000 Frm 00105 Fmt 4701 Sfmt 4700 59939 Advanced APM Criteria, Financial Risk, Capitation provision at § 414.1420(d)(7) to align with the definition of capitation risk arrangements that we expressed in the preamble of the CY 2017 Quality Payment Program final rule at 81 FR 77430–77431. We also proposed a technical correction to remove the ‘‘; or’’ and replace it with a ‘‘.’’ at § 414.1420(d)(3)(i) because the paragraph that follows that section does not specify a standard that is necessarily an alternative to the standard under § 414.1420(d)(3)(i), but rather expresses a standard that is independent of the standard under § 414.1420(d)(3)(i) (83 FR 36006). As indicated in the CY 2018 Quality Payment Program final rule at 82 FR 53849–53850, where we established a revenue-based nominal amount standard for Other Payer Advanced APMs, in order to meet the generally applicable nominal amount standard under the Other Payer Advanced APM criteria, the total amount that an APM Entity potentially owes the payer or foregoes under a payment arrangement must be equal to at least: For the 2019 and 2020 QP Performance Periods, 8 percent of the total combined revenues from the payer to providers and other entities under the payment arrangement; or, 3 percent of the expected expenditures for which an APM Entity is responsible under the payment arrangement. We solicited comment on this proposal. We did not receive any comments in response to this proposal. We are finalizing our proposal to remove the ‘‘; or’’ and replace it with a ‘‘.’’ at § 414.1420(d)(3)(i) because the paragraph that follows that section does not specify a standard that is necessarily an alternative to the standard under § 414.1420(d)(3)(i), but rather expresses a standard that is independent of the standard under § 414.1420(d)(3)(i). We also proposed to revise § 414.1440(d)(3) to correct a typographical error by replacing the ‘‘are’’ with ‘‘is’’ in the third clause of the second sentence (83 FR 36006). We solicited comment on this proposal. We did not receive any comments in response to this proposal. We are finalizing our proposal to revise § 414.1440(d)(3) to correct a typographical error by replacing the ‘‘are’’ with ‘‘is’’ in the third clause of the second sentence. c. Summary of Final Policies We are finalizing these technical corrections to our regulations at §§ 414.1415(b)(1), 414.1420(d)(3)(ii), E:\FR\FM\23NOR3.SGM 23NOR3 59940 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 414.1415(c), 414.1420(d), 414.1415(c)(6), 414.1420(d)(7), 414.1420(d)(3)(i), and 414.1440(d)(3) as proposed. IV. Requests for Information This section addressed two requests for information (RFI). A. Request for Information on Promoting Interoperability and Electronic Healthcare Information Exchange Through Possible Revisions to the CMS Patient Health and Safety Requirements for Hospitals and Other Medicare- and Medicaid-Participating Providers and Suppliers In the CY 2019 PFS proposed rule (83 FR 35704 through 36368), we included an RFI related to promoting interoperability and electronic health care information exchange (83 FR 36006 through 36009). We received approximately 79 timely pieces of correspondence on this RFI. We appreciate the input provided by commenters. B. Request for Information on Price Transparency: Improving Beneficiary Access to Provider and Supplier Charge Information In the CY 2019 PFS proposed rule (83 FR 35704 through 36368), we included an RFI related to price transparency and improving beneficiary access to provider and supplier charge information (83 FR 36009 through 36010). We received approximately 94 timely pieces of correspondence on this RFI. We appreciate the input provided by commenters. V. Medicare Shared Savings Program; Accountable Care Organizations— Pathways to Success amozie on DSK3GDR082PROD with RULES3 A. Statutory and Regulatory Background On March 23, 2010, the Patient Protection and Affordable Care Act (Pub. L. 111–148) was enacted, followed by enactment of the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111–152) on March 30, 2010, which amended certain provisions of the Patient Protection and Affordable Care Act (hereinafter collectively referred to as ‘‘the Affordable Care Act’’). Section 3022 of the Affordable Care Act amended Title XVIII of the Act (42 U.S.C. 1395 et seq.) by adding section 1899 to the Act to establish the Shared Savings Program to facilitate coordination and cooperation among health care providers to improve the quality of care for Medicare FFS beneficiaries and reduce the rate of growth in expenditures under Medicare Parts A and B. See 42 U.S.C. 1395jjj. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 The final rule establishing the Shared Savings Program appeared in the November 2, 2011 Federal Register (Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations; Final Rule (76 FR 67802) (hereinafter referred to as the ‘‘November 2011 final rule’’)). We viewed this final rule as a starting point for the program, and because of the scope and scale of the program and our limited experience with shared savings initiatives under FFS Medicare, we built a great deal of flexibility into the program rules. Through subsequent rulemaking, we have revisited and amended Shared Savings Program policies in light of the additional experience we gained during the initial years of program implementation as well as from testing through the Pioneer ACO Model, the Next Generation ACO Model and other initiatives conducted by the Center for Medicare and Medicaid Innovation (Innovation Center) under section 1115A of the Act. A major update to the program rules appeared in the June 9, 2015 Federal Register (Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations; Final Rule (80 FR 32692) (hereinafter referred to as the ‘‘June 2015 final rule’’)). A final rule addressing changes related to the program’s financial benchmark methodology appeared in the June 10, 2016 Federal Register (Medicare Program; Medicare Shared Savings Program; Accountable Care Organizations—Revised Benchmark Rebasing Methodology, Facilitating Transition to Performance-Based Risk, and Administrative Finality of Financial Calculations (81 FR 37950) (hereinafter referred to as the ‘‘June 2016 final rule’’)). We have also made use of the annual calendar year (CY) Physician Fee Schedule (PFS) rules to address updates to the Shared Savings Program quality measures, scoring, and quality performance standard, the program’s beneficiary assignment methodology and certain other issues.34 34 See for example: Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule, Clinical Laboratory Fee Schedule & Other Revisions to Part B for CY 2014; Final Rule (78 FR 74230, Dec. 10, 2013). Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule, Clinical Laboratory Fee Schedule & Other Revisions to Part B for CY 2015; Final Rule (79 FR 67548, Nov. 13, 2014). Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule, Clinical Laboratory Fee Schedule & Other Revisions to Part B for CY 2016; Final Rule (80 FR 70886, Nov. 16, 2015). Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule, Clinical Laboratory Fee Schedule & Other Revisions to Part B for CY 2017; Final Rule (81 FR 80170, Nov. 15, 2016). Medicare Program; Revisions PO 00000 Frm 00106 Fmt 4701 Sfmt 4700 Policies applicable to Shared Savings Program ACOs have continued to evolve based on changes in the law. The Medicare Access and CHIP Reauthorization Act of 2015 (Pub. L. 114–10) (MACRA) established the Quality Payment Program. In the CY 2017 Quality Payment Program final rule with comment period (81 FR 77008), CMS established regulations for the Merit-Based Incentive Payment System (MIPS) and Advanced Alternative Payment Models (APMs) and related policies applicable to eligible clinicians who participate in the Shared Savings Program. The requirements for assignment of Medicare FFS beneficiaries to ACOs participating under the program were amended by the 21st Century Cures Act (Pub. L. 114–255). Accordingly, we revised the program’s regulations in the CY 2018 PFS final rule to reflect these new requirements. On February 9, 2018, the Bipartisan Budget Act of 2018 was enacted (Pub. L. 115–123), amending section 1899 of the Act to provide for the following: Expanded use of telehealth services by physicians or practitioners participating in an applicable ACO to a prospectively assigned beneficiary, greater flexibility in the assignment of Medicare FFS beneficiaries to ACOs by allowing ACOs in tracks under retrospective beneficiary assignment a choice of prospective assignment for the agreement period, permitting Medicare FFS beneficiaries to voluntarily identify an ACO professional as their primary care provider and mandating that any such voluntary identification will supersede claims-based assignment, and allowing ACOs under certain two-sided models to establish CMS-approved beneficiary incentive programs. On August 17, 2018 a proposed rule, titled ‘‘Medicare Program; Medicare Shared Savings Program; Accountable Care Organizations—Pathways to Success’’ (hereinafter referred to as the ‘‘August 2018 proposed rule’’), appeared in the Federal Register (83 FR 41786). This proposed rule would provide a new direction for the Shared Savings Program by establishing pathways to success through redesigning the participation options available under the program to encourage ACOs to transition to two-sided models (in which they may share in savings and are also accountable for repaying any shared losses). As part of the proposed redesign of the program, we proposed to to Payment Policies under the Physician Fee Schedule, Clinical Laboratory Fee Schedule & Other Revisions to Part B for CY 2018; Final Rule (82 FR 52976, Nov. 15, 2017). E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations establish two tracks under the program—the BASIC track and the ENHANCED track. These new participation options were designed to increase savings for the Trust Funds and mitigate losses, reduce gaming opportunities, and promote regulatory flexibility and free-market principles. The August 2018 proposed rule would also provide new tools to support coordination of care across settings and strengthen beneficiary engagement; ensure rigorous benchmarking; and promote the use of interoperable electronic health record technology among ACO providers/suppliers. We received 470 timely pieces of correspondence in response to the August 2018 proposed rule. In the following sections of this final rule, we address a subset of the proposals described in the August 2018 proposed rule. We summarize and respond to the significant public comments on these proposals and discuss our final policies with respect to these issues after taking into consideration the public comments we received on this subset of proposals. We are not addressing the other topics included in the August 2018 proposed rule at this time. We will summarize and respond to public comments on these other proposed policies in a forthcoming final rule. We also received comments that are outside the scope of the August 2018 proposed rule. We may consider these comments when evaluating current Shared Savings Program policies and contemplating future refinements to the program. amozie on DSK3GDR082PROD with RULES3 B. Finalization of Certain Provisions of the Shared Savings Program August 2018 Proposed Rule In this section of the final rule, we discuss the proposal, the comments received, and the final action that we are taking for the following proposals in the August 2018 proposed rule: • A voluntary 6-month extension for existing ACOs whose participation agreements expire on December 31, 2018, and the methodology for determining financial and quality performance for this 6-month performance year from January 1, 2019 through June 30, 2019. We believe it is necessary to finalize the extension before these ACOs’ participation agreements expire on December 31, 2018, so that they can continue their participation in the program without interruption. It is also necessary to finalize the methodology for determining ACO quality and financial performance for the extension period in advance of the 6-month performance year beginning on January 1, 2019. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 • Implementation of the provisions of section 50331 of the Bipartisan Budget Act of 2018 on voluntary alignment. The Bipartisan Budget Act was enacted earlier this year, and we believe it is most consistent with the requirements of the statute to revise our voluntary alignment policies effective with assignment for performance years starting on January 1, 2019, to reflect the additional flexibility given to beneficiaries in selecting their primary care provider. • A modification to the definition of primary care services used in assigning beneficiaries to ACOs to reflect recent code changes. Including these codes in the definition of primary care services will improve the accuracy of the assignment methodology and help to ensure that beneficiaries are assigned to the ACO that is responsible for coordinating their overall care. • Relief for ACOs and their clinicians impacted by extreme and uncontrollable circumstances in performance year 2018 and subsequent years. We believe it is necessary to finalize the changes to the extreme and uncontrollable circumstances policies for the Shared Savings Program as quickly as possible to ensure that relief is available for ACOs affected by the recent hurricanes in North Carolina and Florida and other disasters during 2018. • Revisions to program requirements to further promote interoperability among ACO providers and suppliers. We believe it is necessary to finalize changes to our CEHRT use requirements to align with the Quality Payment Program. We are also making technical changes to update the authority citation for 42 CFR part 425 to conform with OFR requirements. The changes will be effective on December 31, 2018. Applicability or implementation dates may vary, depending on the policy, and the timing specified in this final rule. By indicating that a provision is applicable to a performance year (PY) or agreement period, activities related to implementation of the policy may precede the start of the performance year or agreement period. 1. Participation Options for Agreement Periods Beginning in 2019 In this final rule, we are addressing a subset of the proposals in the August 2018 proposed rule for participation options for agreement periods beginning in 2019. In the August 2018 proposed rule, we stated that we would forgo an application cycle for a January 1, 2019 agreement start date and proposed to allow for a July 1, 2019 agreement start PO 00000 Frm 00107 Fmt 4701 Sfmt 4700 59941 date. We proposed an approach for determining financial and quality performance for two 6-month performance years during 2019, with the first from January 1, 2019 through June 30, 2019, for ACOs with participation agreements expiring on December 31, 2018, that elect a voluntary 6-month extension, and the second from July 1, 2019 through December 31, 2019, for ACOs entering a new agreement period beginning July 1, 2019. We also proposed an approach for determining financial and quality performance for the performance period from January 1, 2019 through June 30, 2019 for an ACO starting a 12-month performance year on January 1, 2019, that terminates its participation agreement with an effective date of termination of June 30, 2019, and enters a new agreement period beginning on July 1, 2019, referred to as ‘‘early renewals.’’ In this final rule, we are addressing our proposals to allow for a voluntary 6month extension for ACOs whose agreement periods expire on December 31, 2018, and to establish a methodology for determining financial and quality performance for the 6month performance year from January 1, 2019 through June 30, 2019. These proposals were necessary to prevent some ACOs from experiencing an involuntary gap in participation as a result of our decision to forgo an application cycle in 2018 for a January 1, 2019 agreement start date. Therefore, in this section of the final rule, we summarize and respond to comments and address final actions specific to our proposals regarding the 6-month extension and the methodology for determining financial and quality performance for the 6-month performance year from January 1, 2019 through June 30, 2019. As we describe in this section, some modifications to our proposals are necessary because of the limited scope of this final rule. In a forthcoming final rule, we anticipate summarizing and responding to public comments on the other proposed policies related to determining financial and quality performance in 2019 for the following: (1) The performance period from January 1, 2019 through June 30, 2019, for ACOs starting a 12-month performance year on January 1, 2019, that terminate their participation agreement with an effective date of termination of June 30, 2019, and enter a new agreement period beginning on July 1, 2019; and (2) the 6-month performance year from July 1, 2019 through December 31, 2019, for ACOs entering an agreement period beginning on July 1, 2019. E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59942 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations a. Voluntary Extension for a 6-Month Performance Year From January 1, 2019 Through June 30, 2019, for ACOs Whose Current Agreement Period Expires on December 31, 2018 In section II.A.7. of the August 2018 proposed rule (83 FR 41847), we explained that we were forgoing the application cycle that otherwise would take place during CY 2018 for a January 1, 2019 start date for new Shared Savings Program participation agreements, initial use of the Skilled Nursing Facility (SNF) 3-day rule waiver, and entry into the Track 1+ Model, and we proposed to offer a July 1, 2019 start date as the initial opportunity for ACOs to enter an agreement period under the proposed BASIC track or ENHANCED track, which would be offered under the proposed redesign of the program’s participation options. We proposed the July 1, 2019 start date as a one-time opportunity, and thereafter we would resume our typical process of offering an annual application cycle that allows for review and approval of applications in advance of a January 1 agreement start date. We proposed that ACOs that entered a first or second agreement period with a start date of January 1, 2016 could elect to extend their agreement period for an optional fourth performance year, defined as the 6-month period from January 1, 2019 through June 30, 2019. This election to extend the agreement period would be voluntary and an ACO could choose not to extend its agreement period, in which case it would conclude its participation in the program with the expiration of its current agreement period on December 31, 2018. We proposed that the ACO’s voluntary election to extend its agreement period must be made in the form and manner and according to the timeframe established by CMS, and that an ACO executive who has the authority to legally bind the ACO must certify the election. We explained our expectation that this election process, if finalized, would begin in 2018 following the publication of the final rule, as part of the annual certification process in advance of 2019 (described in section II.A.7.c.(2) of the August 2018 proposed rule (83 FR 41855)). We noted that this optional 6-month agreement period extension would be a one-time exception for ACOs with agreements expiring on December 31, 2018, and would not be available to other ACOs that are currently participating in a 3year agreement in the program, or to future program entrants. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 In the August 2018 proposed rule, we noted that under the existing provision at § 425.210, the ACO must provide a copy of its participation agreement with CMS to all ACO participants, ACO providers/suppliers, and other individuals and entities involved in ACO governance. Further, all contracts or arrangements between or among the ACO, ACO participants, ACO providers/ suppliers, and other individuals or entities performing functions or services related to ACO activities must require compliance with the requirements and conditions of the program’s regulations, including, but not limited to, those specified in the participation agreement with CMS. We proposed that an ACO that elects to extend its participation agreement by 6 months must notify its ACO participants, ACO providers/ suppliers and other individuals or entities performing functions or services related to ACO activities of this continuation of participation and must require their continued compliance with the program’s requirements for the 6month performance year from January 1, 2019 through June 30, 2019. As discussed in section II.A.2. of the August 2018 proposed rule (83 FR 41799 through 41800), we proposed modifications to the definition of ‘‘agreement period’’ in § 425.20 to broaden the definition to generally refer to the term of the participation agreement. We also proposed to add a provision at § 425.200(b)(2) specifying that the term of the participation agreement is 3 years and 6 months for an ACO that entered an agreement period starting on January 1, 2016, that elects to extend its agreement period until June 30, 2019, and this election is made in the form and manner and according to the timeframe established by CMS, and certified by an ACO executive who has the authority to legally bind the ACO (83 FR 41849). For consistency, we also proposed minor formatting changes to the existing provision at § 425.200(b)(2) and (b)(3) to italicize the header text. We also proposed to revise the definition of ‘‘performance year’’ in § 425.20 to mean the 12-month period beginning on January 1 of each year during the agreement period, unless otherwise specified in § 425.200(c) or noted in the participation agreement. We also proposed revisions to § 425.200(c) to make necessary formatting changes and specify additional exceptions to the definition of performance year as a 12-month period. Specifically, we proposed to add a provision specifying that for an ACO that entered a first or second agreement period with a start date of January 1, PO 00000 Frm 00108 Fmt 4701 Sfmt 4700 2016, and that elects to extend its agreement period by a 6-month period, the ACO’s fourth performance year is the 6-month period between January 1, 2019, and June 30, 2019. Similarly, we proposed to add a provision specifying that for an ACO that entered an agreement period with a start date of July 1, 2019, the ACO’s first performance year of the agreement period is defined as the 6-month period between July 1, 2019, and December 31, 2019 (83 FR 41849). In light of the proposed modifications to § 425.200(c) to establish two 6-month performance years during CY 2019, we proposed revisions to the regulation at § 425.200(d), which reiterates an ACO’s obligation to submit quality measures in the form and manner required by CMS for each performance year of the agreement period, to address the quality reporting requirements for ACOs participating in a 6-month performance year during CY 2019 (83 FR 41849). We also considered forgoing an application cycle for a 2019 start date altogether and allowing ACOs to enter agreement periods under the proposed BASIC track and ENHANCED track for the first time beginning on January 1, 2020. This approach would allow ACOs additional time to consider the redesign of the program, make organizational and operational plans, and implement business and investment decisions, and would avoid the complexity of needing to determine performance based on 6month performance years during CY 2019. However, we noted that our proposed approach of offering an application cycle during 2019 for an agreement period start date of July 1, 2019 would allow for a more rapid progression of ACOs to the redesigned participation options, starting in mid2019. We further noted that, under this alternative, we would also want to offer ACOs that started a first or second agreement period on January 1, 2016, a means to continue their participation between the conclusion of their current 3-year agreement period (December 31, 2018) and the start of their next agreement period (January 1, 2020), should the ACO wish to continue in the program. We indicated that under that alternative, which would postpone the start date for the new participation options to January 1, 2020, we would allow ACOs that started a first or second agreement period on January 1, 2016, to elect a 12-month extension of their current agreement period to cover the duration of CY 2019. We sought comment on these proposals and the related considerations, as well as the alternatives considered. E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations Comment: Regarding the program’s application cycles, most commenters generally supported CMS’ decision to forgo an application cycle during CY 2018 for a January 1, 2019 agreement start date. Several commenters explained their support for this decision was due to the significant revisions to program policies contained in the proposed rule. Response: We thank commenters for their support of our decision to forgo the application cycle that otherwise would take place during CY 2018 for a January 1, 2019 start date for new Shared Savings Program participation agreements. Comment: Of the comments addressing the length of the extension for ACOs with agreement periods expiring December 31, 2018, a few commenters generally supported the proposed participation options for agreement periods beginning in 2019, including the proposed 6-month extension. Several commenters stated their support for CMS’ proposal to allow ACOs with agreement periods ending December 31, 2018, to extend their agreements through June 30, 2019. Several commenters suggested that CMS allow ACOs whose agreement periods expire on December 31, 2018, an option to extend their current participation agreement by either 6 months or 12 months. In addition, many commenters supported allowing these ACOs the opportunity to elect a voluntary 12month extension of their current agreement period, for a fourth performance year from January 1, 2019 through December 31, 2019. One commenter, whose comment was primarily focused on the applicability of policies to Track 1 ACOs, specifically recommended that this 12-month extension option should be offered for Track 1 ACOs. One commenter suggested that CMS permit Track 3 ACOs a 12-month extension for the performance year from January 1, 2019 through December 31, 2019, and that CMS apply certain aspects of the proposed program redesign, including the use of factors based on regional FFS expenditures in establishing, updating and adjusting the ACO’s historical benchmark and the availability of beneficiary incentive programs, during this optional fourth 12-month performance year, enabling these Track 3 ACOs to gain experience with these policies before deciding whether to continue their participation in the Shared Savings Program in the ENHANCED track. Some commenters explained that providing a 12-month extension option would give ACOs additional time to VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 analyze program changes and prepare for the application process. One commenter expressed concern that a 6month extension would provide a limited and inadequate amount of time for ACOs to consider participation options under a redesigned program, if a final rule establishing a July 1, 2019 start date is not issued until later in 2018. This commenter expressed the belief that this limited time to consider participation options in advance of a July 1, 2019 start date (if finalized) and general uncertainty about program policies would result in program attrition, due to ACOs and ACO participants electing not to continue in the program at the end of their current agreement. One commenter explained a 12-month extension would give ACOs additional time to evaluate whether they have the appropriate structure in place, implement processes to comply with new regulations, and make necessary changes to their ACO participant and ACO provider/supplier networks. One commenter explained a 12-month extension would provide current ACOs with additional time and experience under their current agreement periods. Some commenters explained that providing a 12-month extension could avoid the complexity and increased burden on providers, practices, ACOs, and CMS that could potentially result from ACOs’ participation in two, 6month performance years in CY 2019. Other commenters raised concerns about making ACO participant list changes, and modifying agreements with their ACO participants, to allow for participation in two, 6-month performance years during CY 2019, with each performance year under a separate participation agreement: The first 6month performance year under their current participation agreement (in an extension of their current agreement period); and the second 6-month performance year under a new participation agreement under one of the proposed redesigned participation options. Some commenters requesting a 12-month extension, or the choice between a 6-month or a 12-month extension, also raised concerns about the methodology for determining financial and quality performance for two, 6-month performance years during CY 2019. We summarize and respond to comments related to the methodology for determining performance for the 6-month performance year from January 1, 2019 through December 31, 2019, and other program policies applicable to ACOs participating in this 6-month performance year, in sections V.B.1.b. and V.B.1.c. of this final rule. PO 00000 Frm 00109 Fmt 4701 Sfmt 4700 59943 Response: We are not addressing in this final rule, comments on the timing for implementing the proposed redesign of the Shared Savings Program’s participation options. However, we believe it is important to allow for continuity in participation for ACOs whose participation agreements expire December 31, 2018. We appreciate commenters’ concerns about preparing to enter a new agreement period in light of uncertainty around the participation options that may be available. However, we note that, based on the proposals in the August 2018 proposed rule, ACOs whose agreement periods expire on December 31, 2018, that were interested in continuing their participation in the program have had an opportunity to identify their likely ACO participants for the proposed 6-month performance year from January 1, 2019 through June 30, 2019, and have received preliminary feedback from CMS for ACO participant list additions for the performance year beginning on January 1, 2019. Moreover, we believe these ACOs generally have begun preparing the necessary revisions to their agreements with ACO participants and ACO providers/ suppliers and, if under a two-sided model to extend their repayment mechanism in anticipation of the possibility that we would finalize the proposed 6-month extension period. We believe these ACOs have also been weighing their participation options in advance of applying to renew for a subsequent agreement period, and will have additional time to make these determinations during the 6-month extension (if elected). In particular, ACOs reaching the conclusion of their second agreement period under Track 1, would have been weighing their participation options under two-sided models, given the current requirement that ACOs transition to a two-sided model by the start of their third agreement period. In fact, the 6-month extension allows ACOs completing their second agreement period in Track 1 to continue participation under their current agreement period and thereby receive additional time under a onesided model that otherwise would not have been available to these ACOs under the program’s current regulations. We also believe it is important to ensure we retain the flexibility to allow ACOs to more rapidly transition, starting as early as July 1, 2019, to the proposed new participation options, should they be finalized, including the participation options that would be Advanced APMs that would allow eligible clinicians participating in the ACO to qualify for incentive payments E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59944 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations under the Quality Payment Program. We believe that rapid transition to the new participation options would drive more meaningful systematic change in ACOs, which have the potential to control their assigned beneficiaries’ Medicare Parts A and B FFS expenditures by coordinating care across care settings, and thus to achieve significant change in spending. At this time, we believe the proposed 6-month extension for a 6-month performance year from January 1, 2019 through June 30, 2019, strikes an appropriate balance between these factors. To reduce the possibility for selective participation bias that could adversely affect the Trust Funds, we believe the same option for extending their current participation agreement should be made available to all eligible ACOs whose agreement periods expire December 31, 2018, as opposed to offering ACOs the option to choose between either a 6-month or a 12-month extension, or offering extensions of different lengths to ACOs based on their current participation track. For example, we believe that if we offered a choice regarding the length of the extension, only ACOs that would expect to benefit from being rebased under new program policies would elect a 6-month extension in order to allow the regional rebasing policies to apply sooner. We also decline to adopt the commenter’s suggestions that we finalize certain aspects of the proposed program redesign, such as the proposed modifications to the methodology for establishing, adjusting and updating an ACO’s historical benchmark, and certain payment and program flexibilities for eligible ACOs participating under twosided models, and apply these policies to a subset of the ACOs electing the voluntary extension. Continuing to apply the current benchmarking methodology during the optional fourth performance year maintains ACOs’ existing historical benchmarks, allowing them to continue to build on their experience within their current agreement period and provides a more predictable and stable benchmark during the 6-month extension period. We also decline to allow only ACOs that are eligible for and elect the extension to have access to and make use of additional program and payment flexibilities (such as a SNF 3-day rule waiver, unless previously approved, or a beneficiary incentive program) as a way of allowing these organizations to gain experience with these policies in advance of their broader availability (if finalized) to eligible ACOs participating in the program. Our proposals to extend the availability of a SNF 3-day rule waiver and to give ACOs the VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 opportunity to offer beneficiary incentive programs were developed in conjunction with our proposed changes to the participation options for ACOs participating in the Shared Savings Program. Therefore, we believe these proposals need to be considered together as part of a forthcoming final rule addressing our proposals for the overall redesign of the Shared Savings Program. Further, we believe it would be cumbersome to determine ACOs’ eligibility for these flexibilities prior to the start of the performance year beginning January 1, 2019, particularly given the absence of a formal application cycle during CY 2018 during which ACOs could elect to apply for such opportunities. Comment: One commenter pointed to the Regulatory Impact Analysis of the August 2018 proposed rule (83 FR 41926), and our estimate that a 12month extension for ACOs whose participation agreements expire on December 31, 2018, would reduce overall Federal spending by approximately an additional $100 million, as further justification for allowing a 12-month rather than a 6month extension. Response: We believe it is important to allow for continuity in participation for ACOs whose agreement periods expire on December 31, 2018. We also believe it is important to ensure ACOs more rapidly transition to new participation options in the event we finalize a mid-year start date for those participation options in 2019. At this time, we believe the proposed 6-month extension for a 6-month performance year from January 1, 2019 through June 30, 2019, strikes an appropriate balance between these factors. The estimated impact of a 12-month extension for ACOs whose current agreement periods expire on December 31, 2018, is not comparable to the impact estimated for a 6-month extension for this same group of ACOs. To explain further, the impact estimate for a 12-month extension was estimated under a different hypothetical baseline. Differences in participation resulting from a 6-month or a 12-month extension were not a major factor in the impact estimate because under the proposed approach, a 12-month extension would not have changed the ultimate date that renewing ACOs would be required to transition to performance-based risk under the proposed redesign. For example, for Track 1 ACOs, a 12-month extension for performance year 2019 under Track 1 would result in the Track 1 ACO being eligible to participate in proposed BASIC track Level B during performance year 2020, whereas with a PO 00000 Frm 00110 Fmt 4701 Sfmt 4700 6-month extension for a performance year from January 1, 2019 through June 30, 2019, under Track 1, would permit the ACO up to 1.5 years under proposed BASIC track Level B, because the ACO would not automatically transition from Level B to Level C at the start of performance year 2020 under the policies included in the proposed rule. In either event, however, the ACO would be required to participate in performance-based risk under Level C, D, or E of the BASIC track by performance year 2021. There were also a number of other competing factors working in different directions, such as the benchmark the ACO participates under, and the availability of Advanced APM incentive payments, which ultimately led to our projection that the 12-month extension would result in somewhat greater savings over 10 years when compared to the modeling of the proposed 6-month extension. Comment: One commenter expressed confusion over whether the voluntary election for a 6-month performance year from January 1, 2019 through June 30, 2019, was an option for ACOs within an agreement period (such as an ACO that entered an agreement period on January 1, 2018) as part of the proposed early renewal process. Response: The optional 6-month extension is only available for ACOs with agreements expiring on December 31, 2018, and would not be available to other ACOs that are currently participating in a 3-year agreement period in the program because their agreements are not expiring. Thus, these ACOs do not require the option of a 6month extension because their current agreement periods will continue during 2019 and they will not experience a gap in participation as a result of our decision to forgo the application cycle in 2018 for an agreement start date of January 1, 2019. Comment: One commenter suggested that all Track 3 ACOs should be offered an extension of their current agreement period, regardless of the ACO’s agreement period start date. Response: We proposed that the onetime, 6-month extension would only be available to ACOs whose agreement periods expire on December 31, 2018, in order to ensure that these ACOs would be able to continue participation in the Shared Savings Program without any gap. At this time, we decline the commenter’s alternative suggestion that we offer a similar 6-month extension to ACOs whose agreement periods expire in subsequent years. These ACOs would not need a 6-month extension because we anticipate a typical, annual application cycle would be available in E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations future years so that these ACOs could renew their participation agreements and continue their participation in the program without interruption. Comment: Some commenters urged CMS to provide additional guidance and education to ACOs on how ACOs should modify their agreements with their ACO participants for the 2019 performance periods. Several ACOs, with agreement periods expiring on December 31, 2018, submitted comments describing the burden of executing updated participation agreements with their ACO participants to account for the 6-month extension and the start of a new agreement period under one of the new participation options. These commenters explained that expecting the program would offer an application cycle in CY 2018 for a January 1, 2019 agreement start date, their newly executed ACO participant agreements were structured according to the program’s current policies (under the program’s regulations and, as applicable, the terms of the Track 1+ Model) and do not account for the 6month extension or modified participation options under the proposed redesign of the program. One commenter expressed concern that the extension would cause some ACO participants to be operating under a different ACO participation agreement, depending on whether they started participating in the ACO prior to January 1, 2019, or after January 1, 2019, resulting in different sets of expectations, for example with respect to the distribution of shared savings. According to one commenter, the time and cost spent on revising agreements with their ACO participants would significantly burden the ACO and its participants, and delay the execution of many initiatives to reduce costs and improve the quality of care as the ACO would spend time executing revised agreements with its ACO participants rather than focusing on other aspects of its operations. One commenter requested that ACOs whose agreement periods expire on December 31, 2018, be given ample time to secure extensions to their agreements with ACO participants for 2019. Response: To prepare for the extension period, ACOs electing to extend their participation agreement with CMS must update their ACO participant agreements and SNF affiliate agreements, as applicable, before the beginning of the next performance year to reflect the extension of their current agreement period. As part of the annual certification process in advance of 2019, ACOs electing the 6-month extension will be required to certify that they have VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 notified their ACO participants and SNF affiliates, if applicable, of their continued participation in the Shared Savings Program in 2019, and that their ACO participant agreements and SNF affiliate agreements, if applicable, have been updated. However, ACOs will not be required to submit ACO participant agreement or SNF affiliate agreement extensions to CMS. ACOs electing the extension would need to extend all current ACO participant and/or SNF affiliate agreements on or before December 31, 2018, so that entities will continue to be ACO participants or SNF affiliates, as applicable, for the performance year beginning on January 1, 2019. Additionally, the ACO will need to execute ACO participant agreements with any new ACO participants to be added to its ACO participant list effective January 1, 2019. We also note that these ACOs would have been required to revise their ACO participant and SNF affiliate agreements, as applicable, if they had been renewing their participation agreements for a new agreement period beginning January 1, 2019. We also note that we now allow ACOs, ACO participants and SNF affiliates to digitally sign their agreements, which should help to reduce any burden associated with extending agreements. We believe that the timing of the issuance of this final rule will permit sufficient time for ACOs electing to extend their participation agreements to take the necessary steps to extend their ACO participant and SNF affiliate agreements, as applicable, before the start of the 6-month performance year beginning January 1, 2019. In response to the commenter’s concern that the extension would cause some ACO participants to be operating under different sets of expectations (depending on whether they started participating in the ACO prior to January 1, 2019 or after January 1, 2019), we note that for ACOs that elect the 6month extension, the payment methodology under the ACO’s current track would be applicable to determining the ACO’s shared savings or shared losses, if applicable, for the 6month performance year from January 1, 2019 through June 30, 2019. This is the same payment methodology that has applied to the ACO for the duration of its agreement period, beginning on January 1, 2016. Further, we note that with the exception of the requirements specified at § 425.116, the ACO and its ACO participants have significant flexibility to determine the contractual terms that would apply with respect to all ACO PO 00000 Frm 00111 Fmt 4701 Sfmt 4700 59945 participant agreements, including with respect to the use/distribution of shared savings (and payment of shared losses). Comment: One commenter explained that current and prospective ACOs and their leaders are evaluating their options with respect to not only the Shared Savings Program start date, but also to participation in other potential models such as the Direct Provider Contracting (DPC) models anticipated to be tested by CMS’ Innovation Center. The commenter urged CMS to take the whole payment model landscape into account and to take any measures necessary to maximize the level of certainty for healthcare providers and to incentivize participation in higher-risk models over lower-risk models. For example, the commenter recommended that participants in the Shared Savings Program or current Innovation Center models should not be excluded from switching to a DPC model if and when such a model becomes available, regardless of where they are in their current agreement period or the lifecycle of their current model. Response: We work to align and otherwise create synergies between the Shared Savings Program and the payment and service delivery models tested by the Innovation Center. We have policies in place to take into account overlap between the Shared Savings Program and Innovation Center models, which are designed to test new payment and service delivery models for the purpose of innovating in the areas of healthcare delivery and shared accountability for quality and financial performance, whenever possible. We continue to monitor these policies and make refinements as we gain experience and lessons learned from these interactions. When new models are announced, we encourage ACOs and their leaders to engage in dialogue with the Innovation Center and Shared Savings Program staff to inform their decision-making regarding the participation options. After considering the comments received, we are finalizing our proposal to allow ACOs that entered a first or second agreement period beginning on January 1, 2016, to voluntarily elect a 6month extension of their current agreement period for a fourth performance year from January 1, 2019 through June 30, 2019. For the reasons discussed, we believe this extension is necessary in order to avoid an involuntary gap in participation and to provide ACOs with an opportunity to prepare for a more rapid transition to the proposed new participation options, including new Advanced APMs that would allow eligible clinicians E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59946 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations participating in these ACOs to qualify for incentive payments under the Quality Payment Program. We received no comments on the proposed modifications to the definitions of ‘‘agreement period’’ and ‘‘performance year’’ in § 425.20 or to the regulation at § 425.200 to establish the 6-month extension and to make certain technical and conforming changes. We are finalizing as proposed the modifications to the definition of ‘‘agreement period’’ in § 425.20 to broaden the definition to generally refer to the term of the participation agreement and the revisions to § 425.200(a) to allow for agreement periods greater than 3 years. We are also finalizing our proposal to add a provision at § 425.200(b)(2) specifying that the term of the participation agreement is 3 years and 6 months for an ACO that entered an agreement period starting on January 1, 2016, that elects to extend its agreement period until June 30, 2019, and this election is made in the form and manner and according to the timeframe established by CMS, and certified by an ACO executive who has the authority to legally bind the ACO. For consistency, we are also finalizing as proposed the minor formatting changes to the existing provisions at § 425.200(b)(2) and (b)(3) to italicize the header text. We are also finalizing as proposed the revision to the definition of ‘‘performance year’’ in § 425.20 to mean the 12-month period beginning on January 1 of each year during the agreement period, unless otherwise specified in § 425.200(c) or noted in the participation agreement. Therefore, we are also finalizing the proposed revisions to § 425.200(c) to make necessary formatting changes and specify an additional exception to the definition of performance year as a 12month period. Specifically, we are finalizing our proposal to add a provision specifying that for an ACO that entered a first or second agreement period with a start date of January 1, 2016, and that elects to extend its agreement period by a 6-month period, the ACO’s fourth performance year is the 6-month period between January 1, 2019, and June 30, 2019. In light of the modifications we are finalizing to § 425.200(c) to establish a 6-month performance year during CY 2019, we are also finalizing the proposed revisions to the regulation at § 425.200(d), which reiterates an ACO’s obligation to submit quality measures in the form and manner required by CMS for each performance year of the agreement period, to address the quality reporting requirements for ACOs VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 participating in the 6-month performance year from January 1, 2019 through June 30, 2019. As described elsewhere in this final rule, ACOs electing the voluntary 6-month extension will be required to report quality measures for the 2019 reporting period, based on CY 2019, consistent with the existing quality reporting process and methodology. b. Methodology for Determining Financial and Quality Performance for the 6-Month Performance Year From January 1, 2019 Through June 30, 2019 (1) Background and Description of Methodology Under our proposed approach to determining performance for the 6month performance year from January 1, 2019 through June 30, 2019, after the conclusion of CY 2019, CMS would reconcile the financial and quality performance of ACOs that participated in the Shared Savings Program during 2019. For ACOs that extended their agreement period for the 6-month performance year from January 1, 2019 through June 30, 2019, CMS would first reconcile the ACO based on its performance during the entire 12-month calendar year, and then pro-rate the calendar year shared savings or shared losses to reflect the ACO’s participation for only half of the calendar year. In the August 2018 proposed rule, we explained this approach would avoid a more burdensome interim payment process that could accompany an alternative proposal to instead implement, for example, an 18-month performance year. Consistent with the 18- and 21-month performance years offered for the first cohorts of Shared Savings Program ACOs, such a policy could require ACOs to establish a repayment mechanism that otherwise might not be required, create uncertainty over whether the ACO may ultimately need to repay CMS based on final results for the extended performance year, and delay ACOs seeing a return on their investment in program participation if eligible for shared savings. We explained our belief that the proposed approach would allow continuity in program operations, including operations that occur on a calendar year basis. Specifically, the proposed approach would allow payment reconciliation to remain on a calendar year basis, which would be most consistent with the calendar yearbased methodology for calculating benchmark expenditures, trend and update factors, risk adjustment, county expenditures and regional adjustments. PO 00000 Frm 00112 Fmt 4701 Sfmt 4700 We explained that deviating from a 12month reconciliation calculation by using fewer than 12 months of performance year expenditures could interject actuarial biases relative to the benchmark expenditures, which are based on 12-month benchmark years. As a result, we believed the proposed approach of reconciling ACOs based on a 12-month period would protect the actuarial soundness of the financial reconciliation methodology. We also explained our belief that the alignment of the proposed approach with the standard methodology used to perform the same calculations for 12-month performance years that correspond to a calendar year would make it easier for ACOs and other program stakeholders to understand the proposed methodology. As is the case with typical calendar year reconciliations in the Shared Savings Program, we anticipated results with respect to participation during CY 2019 would be made available to ACOs in summer 2020. We explained that this would allow those ACOs that are eligible to share in savings as a result of their participation in the program during CY 2019 to receive payment of shared savings following the conclusion of the calendar year consistent with the standard process and timing for annual payment reconciliation under the program. In section II.A.7.b.2 of the August 2018 proposed rule (83 FR 41851 through 41853), we described in detail our proposed approach to determining an ACO’s performance for the 6-month performance year from January 1, 2019 through June 30, 2019. We also proposed that these policies would apply to ACOs that begin a 12-month performance year on January 1, 2019, but elect to terminate their participation agreement with an effective date of termination of June 30, 2019, in order to enter a new agreement period starting on July 1, 2019 (early renewals). Our proposed policies addressed the following: (1) The ACO participant list that will be used to determine beneficiary assignment; (2) the approach to assigning beneficiaries; (3) the quality reporting period; (4) the benchmark year assignment methodology and the methodology for calculating, adjusting and updating the ACO’s historical benchmark; and (5) the methodology for determining shared savings and shared losses. We proposed to specify these policies for reconciling the 6-month period from January 1, 2019 through June 30, 2019, in paragraph (b) of a new section of the regulations at § 425.609. We proposed to use the ACO participant list for the performance year beginning January 1, 2019, to determine E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations beneficiary assignment as specified in §§ 425.402 and 425.404, and according to the ACO’s track as specified in § 425.400. As discussed in section II.A.7.c. of the August 2018 proposed rule (83 FR 41855 through 41856), we proposed to allow all ACOs, including ACOs entering a 6-month performance year, to make changes to their ACO participant list in advance of the performance year beginning January 1, 2019. Related considerations are discussed in section V.B.1.c.(2) of this final rule. To determine beneficiary assignment, we proposed to consider the allowed charges for primary care services furnished to the beneficiary during a 12month assignment window, allowing for a 3 month claims run out. For the 6month performance year from January 1, 2019 through June 30, 2019, we proposed to determine the assigned population using the following assignment windows: • For ACOs under preliminary prospective assignment with retrospective reconciliation, the assignment window would be CY 2019. • For ACOs under prospective assignment, Medicare FFS beneficiaries would be prospectively assigned to the ACO based on the beneficiary’s use of primary care services in the most recent 12 months for which data are available. For example, in determining prospective beneficiary assignment for the January 1, 2019 through June 30, 2019 performance year we could use an assignment window from October 1, 2017 through September 30, 2018, to align with the off-set assignment window typically used to determine prospective assignment prior to the start of a calendar year performance year. Beneficiaries would remain prospectively assigned to the ACO at the end of CY 2019 unless they meet any of the exclusion criteria under § 425.401(b) during the calendar year. As discussed in section II.A.7.c.(4) of the August 2018 proposed rule (83 FR 41856), to determine ACO performance during a 6-month performance year, we proposed to use the ACO’s quality performance for the 2019 reporting period, and to calculate the ACO’s quality performance score as provided in § 425.502. We also proposed to use a different quality measure sampling methodology depending on whether an ACO participates in both a 6-month performance year (or performance period) beginning on January 1, 2019, and a 6-month performance year beginning on July 1, 2019, or only participates in a 6-month performance year from January 1, 2019 through June 30, 2019. As described in section VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 V.B.1.c.(4) of this final rule, given the limited scope of this final rule, at this time, we are finalizing only our proposal to use the ACO’s latest certified participant list (the ACO participant list effective on January 1, 2019) to determine the quality reporting samples for the 2019 reporting period for ACOs that extend their prior participation agreement for the 6-month performance year from January 1, 2019 to June 30, 2019. Consistent with current program policy, we proposed to determine assignment for the benchmark years based on the most recent certified ACO participant list for the ACO effective for the performance year beginning January 1, 2019. This would be the participant list the ACO certified prior to the start of its agreement period unless the ACO has made changes to its ACO participant list during its agreement period as provided in § 425.118(b). If the ACO has made subsequent changes to its ACO participant list, we would adjust its historical benchmark to reflect the most recent certified ACO participant list. See the Medicare Shared Savings Program, ACO Participant List and Participant Agreement Guidance (July 2018, version 5), available at https://www.cms.gov/ Medicare/Medicare-Fee-for-ServicePayment/sharedsavingsprogram/ Downloads/ACO-Participant-ListAgreement.pdf. For the 6-month performance year from January 1, 2019 through June 30, 2019, we proposed to determine the benchmark and calculate performance year expenditures for assigned beneficiaries as though the performance year were the entire calendar year. The ACO’s historical benchmark would be determined according to the methodology applicable to the ACO based on its agreement period in the program. We would apply the methodology for establishing, updating and adjusting the ACO’s historical benchmark as specified in § 425.602 (for ACOs in a first agreement period) or § 425.603 (for ACOs in a second agreement period), except that data from CY 2019 would be used in place of data for the 6-month performance year in certain calculations, as follows: • The benchmark would be adjusted for changes in severity and case mix between benchmark year 3 and CY 2019 using the methodology that accounts separately for newly and continuously assigned beneficiaries using prospective HCC risk scores and demographic factors as described under §§ 425.604(a)(1) through (3), 425.606(a)(1) through (3), and 425.610(a)(1) through (3). PO 00000 Frm 00113 Fmt 4701 Sfmt 4700 59947 • The benchmark would be updated to CY 2019 according to the methodology for using growth in national Medicare FFS expenditures for assignable beneficiaries described under §§ 425.602(b) (for ACOs in a first agreement period) and 425.603(b) (for ACOs in a second agreement period beginning January 1, 2016). For determining financial performance during the 6-month performance year from January 1, 2019 through June 30, 2019, we would apply the methodology for determining shared savings and shared losses according to the approach specified for the ACO’s track under the terms of the participation agreement that was in effect on January 1, 2019: § 425.604 (Track 1), § 425.606 (Track 2) or § 425.610 (Track 3) and, if applicable, the terms of the ACO’s participation agreement for the Track 1+ Model authorized under section 1115A of the Act. (See discussion in section II.F. of the August 2018 proposed rule (83 FR 41912 through 41914) concerning applicability of proposed policies to Track 1+ Model ACOs.) However, some exceptions to the otherwise applicable methodology were needed because we proposed to calculate the expenditures for assigned beneficiaries over the full CY 2019 for purposes of determining shared savings and shared losses for the 6-month performance year from January 1, 2019 through June 30, 2019. We proposed to use the following steps to calculate shared savings and shared losses: • Average per capita Medicare expenditures for Parts A and B services for CY 2019 would be calculated for the ACO’s performance year assigned beneficiary population. • We would compare these expenditures to the ACO’s updated benchmark determined for the calendar year as previously described. • We would apply the MSR and MLR (as applicable). ++ The ACO’s assigned beneficiary population for the performance year starting on January 1, 2019, would be used to determine the MSR for Track 1 ACOs and the variable MSR/MLR for ACOs in a two-sided model that selected this option at the start of their agreement period. In the event a twosided model ACO selected a fixed MSR/ MLR at the start of its agreement period, and the ACO’s performance year assigned population is below 5,000 beneficiaries, we proposed that the MSR/MLR would be determined based on the number of assigned beneficiaries as described in section II.A.6.b. of the August 2018 proposed rule (83 FR 41837 through 41839). E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59948 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations ++ To qualify for shared savings, the ACO’s average per capita Medicare expenditures for its performance year assigned beneficiaries during CY 2019 must be below its updated benchmark for the year by at least the MSR established for the ACO. ++ To be responsible for sharing losses with the Medicare program, the ACO’s average per capita Medicare expenditures for its performance year assigned beneficiaries during CY 2019 must be above its updated benchmark for the year by at least the MLR established for the ACO. • We would determine the shared savings amount if we determine the ACO met or exceeded the MSR, and if the ACO met the minimum quality performance standards established under § 425.502 as described in the August 2018 proposed rule and section V.B.1.c.(4) of this final rule, and otherwise maintained its eligibility to participate in the Shared Savings Program. We would determine the shared losses amount if we determine the ACO met or exceeded the MLR. To determine these amounts, we would do the following: ++ We would apply the final sharing rate or loss sharing rate to first dollar savings or losses. ++ For ACOs that generated savings that met or exceeded the MSR, we would multiply the difference between the updated benchmark expenditures and performance year assigned beneficiary expenditures by the applicable final sharing rate based on the ACO’s track and its quality performance as calculated under § 425.502. ++ For ACOs that generated losses that met or exceeded the MLR, we would multiply the difference between the updated benchmark expenditures and performance year assigned beneficiary expenditures by the applicable shared loss rate based on the ACO’s track and its quality performance as calculated under § 425.502 (for ACOs in tracks where the loss sharing rate is determined based on the ACO’s quality performance). • We would adjust the shared savings amount, if any, for sequestration by reducing by 2 percent and compare the sequestration-adjusted shared savings amount to the applicable performance payment limit based on the ACO’s track. • We would compare the shared losses amount, if any, to the applicable loss sharing limit based on the ACO’s track. • We would pro-rate any shared savings amount, as adjusted for sequestration and the performance payment limit, or any shared losses VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 amount, as adjusted for the loss sharing limit, by multiplying by one half, which represents the fraction of the calendar year covered by the 6-month performance year. This pro-rated amount would be the final amount of shared savings that would be paid to the ACO for the 6-month performance year or the final amount of shared losses that would be owed by the ACO for the 6month performance year. We sought comment on these proposals. Comment: In general, some commenters supported CMS’ proposed policies governing how shared savings and shared losses would be calculated for the 6-month performance year from January 1, 2019 through June 30, 2019. Some commenters noted there is significant complexity with this approach and urged CMS to clarify and provide additional guidance and education to ACOs concerning how certain operational details will be addressed. Commenters raised concerns about certain aspects of the methodology for determining quality and financial performance for a 6-month performance year under the proposed approach, and other aspects of program participation affected by a 6-month performance year, which we summarize elsewhere within section V.B.1.b. and V.B.1.c. of this final rule, including (but not limited to) the approach to determining beneficiary assignment, flexibilities for making ACO participant list changes, quality reporting considerations, and interactions with the Quality Payment Program policies. Response: We appreciate commenters’ support for the proposed approach for determining financial and quality performance for the 6-month performance year from January 1, 2019 through June 30, 2019. As discussed in the August 2018 proposed rule, we continue to believe in the importance of using this approach to maintain alignment with program calculations made on a 12-month basis. This approach maintains alignment with the program’s existing methodology by using 12 months of expenditure data (for CY 2019) in determining the ACO’s financial performance and a 12-month period for quality measure assessment. In sections V.B.1.b. and V.B.1.c. of this final rule we respond to comments on the specific aspects of the methodology for determining financial and quality performance for the 6-month performance year from January 1, 2019 through June 30, 2019, and other aspects of program participation affected by a 6month performance year. We acknowledge that this approach will add complexity to program policies and PO 00000 Frm 00114 Fmt 4701 Sfmt 4700 certain operational processes. To assist ACOs in understanding the operational details of participation in a 6-month performance year from January 1, 2019 through June 30, 2019, we anticipate providing education and offering outreach to ACOs on these policies through the various methods available, including guidance documents, webinars, FAQs and a weekly newsletter. Comment: A few commenters expressed support for the proposed approach to determining beneficiary assignment for the 6-month performance year from January 1, 2019 through June 30, 2019. Response: In finalizing the 6-month agreement period extension for ACOs that started a first or second agreement period on January 1, 2016, we believe it is appropriate to finalize our proposed approach to determining beneficiary assignment for the performance year from January 1, 2019 through June 30, 2019. To determine beneficiary assignment for the 6-month performance year, we proposed to consider the allowed charges for primary care services furnished to beneficiaries during a 12-month assignment window, allowing for a 3-month claims run out. For ACOs under preliminary prospective assignment with retrospective reconciliation, the assignment window would be CY 2019. For ACOs under prospective assignment, Medicare FFS beneficiaries would be prospectively assigned to the ACO based on beneficiaries’ use of primary care services in the most recent 12 months for which data are available. For example, in determining prospective beneficiary assignment for the January 1, 2019 through June 30, 2019 performance year, we could use an assignment window from October 1, 2017 through September 30, 2018, to align with the off-set assignment window typically used to determine prospective assignment prior to the start of a calendar year performance year. Beneficiaries would remain prospectively assigned to the ACO for the performance year unless they meet any of the exclusion criteria under § 425.401(b) during the calendar year. This approach would maintain alignment with our methodology for assigning beneficiaries to ACOs participating in a 12-month performance year, and allow us to use the same methodology to determine beneficiary assignment for all ACOs participating in a performance year beginning January 1, 2019. This approach would also be consistent with the methodology used to assign beneficiaries for the historical benchmark period. E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations Comment: One commenter noted that the proposal to pro-rate shared savings and shared losses to reflect the 6-month period of participation from January 1, 2019 through June 30, 2019, fails to account for habitual behavior of Medicare beneficiaries. The commenter explained that most annual wellness visits are performed in the 3rd and 4th quarters of the calendar year, and quarter 1 and quarter 2 of the calendar year typically show lower healthcare utilization. According to the commenter, Medicare beneficiaries tend to wait to visit the doctor until their deductible is met, which usually occurs towards the end of the calendar year. The commenter indicated that this delay occurs even for preventive services, like annual wellness visits, that are free at the point of delivery. The commenter also seems to have an incorrect understanding that we are using only quarter 1 and quarter 2 data to determine financial performance for the 6-month performance year from January 1, 2019 through June 30, 2019, suggesting that an approach that only accounts for 6 months of expenditures would result in quality and financial performance determinations that do not fairly reflect the ACO’s quality of care and expenditures for assigned beneficiaries. Another commenter explained that Medicare expenditures demonstrate strong and well-known seasonality which would skew performance results when comparing performance from the first 6 months of the calendar year against a pro-rated benchmark which represents an annual average. Response: Under the proposed approach to determining financial and quality performance for the 6-month performance year from January 1, 2019 through June 30, 2019, as restated in this section of this final rule, we would continue to determine beneficiary assignment and expenditures on a 12month basis. To determine beneficiary assignment, we would consider the allowed charges for primary care services furnished to the beneficiary during a 12-month assignment window, allowing for a 3-month claims run out. We would maintain the calendar yearbased methodology for calculating benchmark expenditures, trend and update factors, and risk adjustment. To determine shared savings and shared losses, we would calculate average per capita Medicare expenditures for Parts A and B services for CY 2019 for the ACO’s performance year assigned beneficiary population and compare this amount to the updated historical benchmark. We would then pro-rate any VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 shared savings or shared losses by multiplying the amounts by one-half, which represents the fraction of the calendar year covered by the 6-month performance year. We believe this approach addresses the commenters’ concerns, because we would capture assigned beneficiaries’ expenditures for the entire CY 2019, which we would compare to a benchmark also based on 12 months of expenditures to maintain consistency and avoid any seasonality or other variation in expenditures that could result from the use of different timeframes. We continue to believe that this approach to reconciling ACOs for the 6-month performance year from January 1, 2019 through June 30, 2019, based on expenditures for the 12-month period corresponding to CY 2019 would protect the actuarial soundness of the financial reconciliation methodology. Comment: A few commenters urged CMS to apply the regional benchmarking methodology in determining the historical benchmark for ACOs that first entered the program in 2013 or 2016 that elect a 6-month extension. One commenter stated that under the program’s current policies, the regional rebasing methodology would apply to ACOs that renew for a second or third agreement period beginning January 1, 2019. This commenter also pointed to CMS’ proposal in the August 2018 proposed rule to incorporate regional expenditures in benchmark calculations beginning with an ACO’s first agreement period for agreement periods beginning on July 1, 2019, and in subsequent years to underscore the urgency for ACOs that may be entering their seventh performance year of program participation without any regional adjustment to be under a benchmarking approach that could help to sustain their accountable care programs and allow them to drive further cost reductions. Several other commenters suggested that CMS rebase the historical benchmark for ACOs electing the extension from January 1, 2019 through June 30, 2019, so that the ACO’s historical benchmark years would be 2016, 2017, and 2018 (as opposed to 2013, 2014, and 2015 under the ACO’s current agreement period), using a regional rebasing methodology. One commenter explained that rebasing these ACOs’ benchmarks using regional factors would remove the drawback related to a delay in agreement period renewal for the organizations on the leading edge of the Shared Savings Program. This commenter also explained that benchmark rebasing would account for non-claims based PO 00000 Frm 00115 Fmt 4701 Sfmt 4700 59949 payments during 2016, 2017, 2018 in the ACO’s historical benchmark, and would eliminate the delay in aligning the benchmark with the full range of services included in calculating performance year expenditures. Response: We appreciate the comments, but we decline to accept the commenters’ suggestions to reset the benchmark for ACOs electing the 6month extension to their current agreement period. As proposed, the 6month extension allows for continued participation under the ACO’s current agreement period, which would not meet the conditions for applying the program’s methodology for rebasing the ACO’s historical benchmark under § 425.603(a). Accordingly, we would continue to update and adjust the benchmarks for ACOs electing this extension using the methodology specified under §§ 425.602 and 425.603(b), as applicable. We also note that for ACOs with second agreement periods beginning on January 1, 2016, that elect the voluntary 6-month extension, the benchmark rebasing methodology that was used to determine their benchmark for their second agreement period accounts for a portion of the savings they generated in their prior agreement period as an adjustment to their historical benchmark. This adjustment coupled with the additional time they will be allowed to participate under their existing historical benchmark should continue to provide a strong incentive during the extension period. (2) Use of Authority Under Section 1899(i)(3) of the Act In the August 2018 proposed rule (83 FR 41851), we explained our belief that the proposal to determine shared savings and shared losses for the 6month performance year starting on January 1, 2019, using expenditures for the entire CY 2019 and then pro-rating these amounts to reflect the shorter performance year, requires the use of our authority under section 1899(i)(3) of the Act to use other payment models. Section 1899(d)(1)(B)(i) of the Act specifies that, in each year of the agreement period, an ACO is eligible to receive payment for shared savings only if the estimated average per capita Medicare expenditures under the ACO for Medicare FFS beneficiaries for Parts A and B services, adjusted for beneficiary characteristics, is at least the percent specified by the Secretary below the applicable benchmark under section 1899(d)(1)(B)(ii) of the Act. We explained our belief that the proposed approach to calculating the expenditures for assigned beneficiaries E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59950 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations over the full calendar year, comparing this amount to the updated benchmark for 2019, and then pro-rating any shared savings (or shared losses, which already are implemented using our authority under section 1899(i)(3) of the Act) for the 6-month performance year involves an adjustment to the estimated average per capita Medicare Part A and Part B FFS expenditures determined under section 1899(d)(1)(B)(i) of the Act that is not based on beneficiary characteristics. Such an adjustment is not contemplated under the plain language of section 1899(d)(1)(B)(i) of the Act. As a result, we stated it would be necessary to use our authority under section 1899(i)(3) of the Act to calculate performance year expenditures and determine the final amount of any shared savings (or shared losses) for a 6-month performance year during 2019, in the proposed manner. In order to use our authority under section 1899(i)(3) of the Act to adopt an alternative payment methodology to calculate shared savings and shared losses for the proposed 6-month performance year from January 1, 2019 through June 30, 2019, we must determine that the alternative payment methodology will improve the quality and efficiency of items and services furnished to Medicare beneficiaries, without additional program expenditures. We explained our belief that the proposed approach of allowing ACOs that started a first or second agreement period on January 1, 2016, to extend their agreement period for a 6month performance year and of allowing entry into the program’s redesigned participation options beginning on July 1, 2019, if finalized, would support continued participation by current ACOs that must renew their agreements to continue participating in the program, while also resulting in more rapid progression to two-sided risk by ACOs within current agreement periods and ACOs entering the program for an initial agreement period. As discussed in the Regulatory Impact Analysis of the August 2018 proposed rule (83 FR 41915 through 41928), we explained our belief that this approach would continue to allow for lower growth in Medicare FFS expenditures based on projected participation trends. Therefore, we did not believe that the proposed methodology for determining shared savings or shared losses for ACOs in a 6-month performance year during 2019 would result in an increase in spending beyond the expenditures that would otherwise occur under the statutory payment methodology in section 1899(d) of the Act. Further, we noted that the proposed approach to VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 measuring ACO quality performance for a 6-month performance year based on quality data reported for CY 2019 would maintain accountability for the quality of care ACOs provide to their assigned beneficiaries. Participating ACOs would also have an incentive to perform well on the quality measures in order to maximize the shared savings they may receive and minimize any shared losses they may be required to pay in tracks where the loss sharing rate is determined based on the ACO’s quality performance. Therefore, we noted our expectation that this proposed approach to reconciling ACOs for a 6-month performance year during 2019 would continue to lead to improvement in the quality of care furnished to Medicare FFS beneficiaries. As discussed in the Regulatory Impact Analysis section of this final rule (section VII.), we believe the approach to determining shared savings and shared losses for the 6-month performance year from January 1, 2019 through June 30, 2019, for ACOs that elect to voluntarily extend their agreement period meets the requirements for use of our authority under section 1899(i)(3) of the Act. The considerations we described in the August 2018 proposed rule were relevant in making this determination. Specifically, we do not believe that the methodology for determining shared savings or shared losses for ACOs in a 6-month performance year from January 1, 2019 through June 30, 2019, (as finalized in this section) will result in an increase in spending beyond the expenditures that would otherwise occur under the statutory payment methodology in section 1899(d) of the Act. Finalizing the voluntary 6-month extension for ACOs whose agreement periods expire on December 31, 2018, will support continued participation by these ACOs, and therefore, also allow for lower growth in Medicare FFS expenditures based on projected participation trends. Further, we believe the approach we are finalizing for reconciling ACOs for a 6-month performance year from January 1, 2019 through June 30, 2019, will lead to continued improvement in the quality of care furnished to Medicare FFS beneficiaries. As described in section V.B.1.c.(4) of this final rule, the approach to measuring ACO quality performance for the 6-month performance year from January 1, 2019 through June 30, 2019, based on quality data reported for CY 2019, will maintain accountability for the quality of care ACOs provide to their assigned beneficiaries. Participating ACOs will PO 00000 Frm 00116 Fmt 4701 Sfmt 4700 have an incentive to perform well on the quality measures in order to maximize the shared savings they may receive and minimize any shared losses they may be required to pay in two-sided risk tracks where the loss sharing rate is determined based on the ACO’s quality performance. (3) Final Policies After consideration of the public comments received, we are finalizing, with modifications, the proposed approach to determine financial and quality performance for ACOs participating in a 6-month performance year from January 1, 2019 through June 30, 2019, as specified in paragraphs (a) and (b) of a new section of the regulations at § 425.609. These modifications are necessary because this final rule only addresses the 6-month extension period, and does not address our proposal to establish a July 1, 2019 agreement start date. In summary, we will do the following to determine an ACO’s financial and quality performance during the 6-month performance year from January 1, 2019 through June 30, 2019: We will compare the ACO’s historical benchmark updated to CY 2019 to the expenditures during CY 2019 for the ACO’s performance year assigned beneficiaries. If the difference is positive and is greater than or equal to the MSR and the ACO has met the quality performance standard, the ACO will be eligible for shared savings. If the ACO is in a twosided model and the difference between the updated benchmark and assigned beneficiary expenditures is negative and is greater than or equal to the MLR (in absolute value terms), the ACO will be liable for shared losses. ACOs will share in first dollar savings and losses. The amount of any shared savings will be determined using the applicable final sharing rate, which is determined based on the ACO’s track for the applicable agreement period, and taking into account the ACO’s quality performance for 2019. We will adjust the amount of shared savings for sequestration, and then cap the amount of shared savings at the applicable performance payment limit for the ACO’s track. Similarly, the amount of any shared losses will be determined using the loss sharing rate for the ACO’s track and, as applicable, for ACOs in tracks with a loss sharing rate that depends upon quality performance, the ACO’s quality performance for 2019.We will then cap the amount of shared losses at the applicable loss sharing limit for the ACO’s track. We will then pro-rate any shared savings or shared losses by E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations multiplying by one-half, which represents the fraction of the calendar year covered by the 6-month performance year. This pro-rated amount will be the final amount of shared savings earned or shared losses owed by the ACO for the 6-month performance year. Because we are not addressing the proposed July 1, 2019 agreement period start date for the proposed new BASIC track and ENHANCED track at this time, we note the following differences between our proposed approach (which contemplated that ACOs may be participating in both a 6-month performance year from January 1, 2019 through June 30, 2019, and a 6-month performance year from July 1, 2019 through December 31, 2019) and our final policies (which are limited to the 6-month performance year from January 1, 2019 through June 30, 2019, for eligible ACOs that elect to extend their agreement period, which would otherwise expire on December 31, 2018): • We are omitting references that we proposed to include in § 425.609(b) in order to establish the applicability of these policies to ACOs that begin a 12month performance year on January 1, 2019, but elect to terminate their participation agreement with an effective date of termination of June 30, 2019, in order to enter a new agreement period starting on July 1, 2019 (early renewals). We are also making clarifying revisions to the introductory text in § 425.609(b). • As described in section V.B.1.c.(4) of this final rule we are finalizing a subset of our proposals for identifying the ACO participant list used in determining quality reporting samples for ACOs participating in a 6-month performance year from January 1, 2019 through June 30, 2019. We are finalizing our proposal to use the ACO’s latest certified ACO participant list (the ACO participant list effective on January 1, 2019) to determine the quality reporting samples for the 2019 reporting period. • We are not addressing at this time the proposals for modifying the MSR/ MLR to address small population sizes (83 FR 41837 through 41839). Therefore, the policies for determining shared savings and shared losses in the event the ACO’s assigned population falls below 5,000, as specified under the program’s current regulations at § 425.110, would apply to ACOs participating in a 6-month performance year from January 1, 2019 through June 30, 2019. Therefore, we will specify in § 425.609(b)(3)(ii)(C)(1) that the ACO’s performance year assigned beneficiary population is used to determine the VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 59951 MSR for Track 1 ACOs and the variable MSR/MLR for ACOs in a two-sided model that selected this option at the start of their agreement period. For twosided model ACOs that selected a fixed MSR/MLR at the start of the ACO’s agreement period, this fixed MSR/MLR is applied. In the event an ACO’s performance year assigned population identified in § 425.609(b)(1) is below 5,000 beneficiaries, the MSR/MLR is determined according to § 425.110(b). • We are also reserving paragraph (c) of § 425.609 in the event that we finalize policies for a second 6-month performance year during CY 2019 in the future. In section V.B.1.c. of this final rule, we discuss our decision to finalize other provisions from the August 2018 proposed rule related to determining performance for the 6-month performance year, as specified in paragraphs (d) and (e) of § 425.609. allow for the 6-month performance year and related revisions to the program’s regulations. As discussed in section II.A.7.c. of the August 2018 proposed rule (83 FR 41854 through 41860), these proposals were developed, in part, based on our proposal to offer an application cycle in CY 2019 for a July 1, 2019 start date. Therefore, we considered that some ACOs would participate in the program for both the 6-month performance year (or performance period) from January 1, 2019 through June 30, 2019, and the 6month performance year from July 1, 2019 through December 31, 2019, while other ACOs would only participate in one of these performance years. In this final rule, we do not address the considerations related to the proposed July 1, 2019 agreement period start date because we are not addressing the proposal to offer that start date at this time. c. Applicability of Program Policies to ACOs Participating in a 6-Month Performance Year In the August 2018 proposed rule (83 FR 41854), we proposed that program requirements under 42 CFR part 425 that are applicable to the ACO under the ACO’s chosen participation track and based on the ACO’s agreement start date would be applicable to an ACO participating in a 6-month performance year, unless otherwise stated. We received no comments on this general proposal and we are finalizing this general approach as proposed. As we explained in the August 2018 proposed rule, this approach will allow routine program operations to continue to apply for ACOs participating under a shorter performance year. Further, it will ensure consistency in the applicability and implementation of our requirements across all program participants, including ACOs participating in a 6month performance year. In section V.B.1.b. of this final rule, we describe limited exceptions to our general policies for determining financial and quality performance which are necessary to ensure calculations can continue to be performed on a calendar year basis and using the most relevant data. In this section, we describe program participation options affected by our decision to forgo an application cycle in CY 2018 for a January 1, 2019 start date, and offer a voluntary extension to allow ACOs whose agreement periods expire on December 31, 2018, to continue their participation in the program for a 6month performance year from January 1, 2019 through June 30, 2019. We discuss modifications to program policies to (1) Unavailability of an Application Cycle for Use of a SNF 3-Day Rule Waiver Beginning January 1, 2019 Eligible ACOs may apply for use of a SNF 3-day rule waiver at the time of application for an initial agreement or to renew their participation. Further, as described in sections II.B.2.a. and II.F. of the August 2018 proposed rule (83 FR 41860, 41912), ACOs within a current agreement period under Track 3, or the Track 1+ Model may apply for a SNF 3day rule waiver, which, if approved, would begin at the start of their next performance year. In light of our decision to forgo an application cycle in CY 2018 for a January 1, 2019 agreement period start date, we are also not offering an opportunity for ACOs to apply for a start date of January 1, 2019, for initial use of a SNF 3-day rule waiver. We proposed that, if finalized, the next available application cycle for a SNF 3day rule waiver would occur in advance of a July 1, 2019 start date. Absent further rulemaking to establish participation options for a start date in 2019 that includes an opportunity for ACOs within existing agreement periods in Track 3 or the Track 1+ Model to apply for a SNF 3-day rule waiver, these ACOs would not have the opportunity to apply to begin use of the waiver until January 1, 2020. PO 00000 Frm 00117 Fmt 4701 Sfmt 4700 (2) Annual Certifications and ACO Participant List Modifications At the end of each performance year, ACOs complete an annual certification process. At the same time as this annual certification process, CMS also requires ACOs to review, certify and electronically sign official program E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59952 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations documents to support the ACO’s participation for the upcoming performance year. As we stated in the August 2018 proposed rule (83 FR 41855), requirements for this annual certification, and other certifications that occur on an annual basis, continue to apply to all currently participating ACOs in advance of the performance year beginning on January 1, 2019. Each ACO is required to certify its list of ACO participant TINs before the start of its agreement period, before every performance year thereafter, and at such other times as specified by CMS in accordance with § 425.118(a). A request to add ACO participants must be submitted prior to the start of the performance year in which these additions would become effective. An ACO must notify CMS no later than 30 days after termination of an ACO participant agreement, and the entity is deleted from the ACO participant list effective as of the termination date of the ACO participant agreement. Absent unusual circumstances, the ACO participant list that was certified prior to the start of the performance year is used to determine beneficiary assignment for the performance year and therefore also the ACO’s quality reporting samples and financial performance. See § 425.118(b)(3) and see also Medicare Shared Savings Program ACO Participant List and Participant Agreement Guidance (July 2018, version 5), available at https:// www.cms.gov/medicare/medicare-feefor-service-payment/ sharedsavingsprogram/downloads/acoparticipant-list-agreement.pdf. As we explained in the August 2018 proposed rule (83 FR 41855), these policies would apply for ACOs participating in a 6month performance year consistent with the terms of the existing regulations. As we explained in the August 2018 proposed rule (83 FR 41855), ACOs that started a first or second agreement period on January 1, 2016, that extend their agreement period for a 6-month performance year beginning on January 1, 2019, would have the opportunity during 2018 to make changes to their ACO participant list to be effective for the 6-month performance year from January 1, 2019, to June 30, 2019. To prepare for the possible implementation of this 6-month performance year, we allowed ACOs that started a first or second agreement period on January 1, 2016, to submit change requests in accordance with usual program procedures to indicate additions, updates, and deletions to their existing ACO participant lists, and if applicable, SNF affiliate lists. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 The program’s current regulations prevent duplication of shared savings payments; thus, under § 425.114, ACOs may not participate in the Shared Savings Program if they include an ACO participant that participates in another Medicare initiative that involves shared savings. In addition, under § 425.306(b)(2), each ACO participant that submits claims for services used to determine the ACO’s assigned population must be exclusive to one Shared Savings Program ACO. If, during a benchmark or performance year (including the 3-month claims run out for such benchmark or performance year), an ACO participant that participates in more than one ACO submits claims for services used in assignment, then CMS will not consider any services billed through the TIN of the ACO participant when performing assignment for the benchmark or performance year; and the ACO may be subject to the pre-termination actions set forth in § 425.216, termination under § 425.218, or both. Comment: Some commenters urged CMS to provide ACOs with opportunities to add and delete ACO participants throughout the performance years (or performance periods) during 2019 and to clarify when such opportunities would be available. These commenters urged CMS to provide additional guidance and education to ACOs on when participant list changes would be permitted. One commenter suggested that CMS should provide an additional opportunity for ACOs with agreement periods expiring on December 31, 2018, to add ACO participants and/or SNF affiliate TINs and CCNs for performance year 2019 because of the short period of time between the issuance of the proposed rule (August 9, 2018) and the final deadline for adding ACO participants for performance year 2019 (September 28, 2018). The commenter explained that the proposed rule caused confusion and uncertainty, and as a result, the commenter believes many ACO participants missed the deadline to be added to the ACO participant lists of other ACOs. The commenter suggested that we should offer an additional opportunity to add ACO participants, with the deadline set for 1 month after publication of a final rule. Response: During 2018, we allowed ACOs that started a first or second agreement period on January 1, 2016, to submit ACO participant change requests in accordance with usual program procedures to indicate additions, updates, and deletions to their existing ACO participant lists and, if applicable, SNF affiliate lists. We noted that the PO 00000 Frm 00118 Fmt 4701 Sfmt 4700 final disposition of any change request submitted by an ACO that started a first or second agreement period on January 1, 2016, would be contingent upon issuance of a final rule establishing an opportunity for these ACOs to continue their participation during 2019 without a gap in participation. As discussed in section V.B.1. of this final rule, we are finalizing the proposed 6-month extension for ACOs whose current participation agreement expire on December 31, 2018. As a result, all ACOs, including those ACOs that will be eligible to elect the voluntary 6-month extension that we are finalizing this final rule, had multiple opportunities to submit change requests to add ACO participants and/or SNF affiliates for performance years starting on January 1, 2019. We also launched a new ACO management system during 2018 that is more user friendly, provides faster feedback, and encourages ACOs to submit change requests to add ACO participants and SNF affiliates with fewer errors than the system that was available in previous years. We do not believe it is operationally feasible to extend the date for ACOs to submit change requests after September 28, 2018, the date we communicated to ACOs as being the deadline to add ACO participants to be effective for performance years beginning on January 1, 2019. Allowing change requests seeking to add new ACO participants to be submitted very close to the end of the calendar year would not provide sufficient time to review and screen providers/suppliers for program integrity issues and create 2019 assignment list reports, and may have other operational impacts (such as on timely production of certain other program reports). We note, however, ACO participants can be terminated and deleted from the ACO participant list at any time during a performance year. The ACO participant is no longer an ACO participant as of the termination effective date of the ACO participant agreement. Absent unusual circumstances, however, the ACO participant data will continue to be utilized for certain operational purposes. (3) Repayment Mechanism Requirements ACOs must demonstrate that they have in place an adequate repayment mechanism prior to entering a two-sided model. The repayment mechanism must be in effect for the duration of an ACO’s participation in a two-sided model and for a sufficient period of time after the conclusion of the agreement period to permit CMS to calculate the amount of E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations shared losses owed and to collect this amount from the ACO (§ 425.204(f)(4)). We noted in our ‘‘Repayment Mechanism Arrangements’’ guidance document that we would consider this standard to be satisfied by a repayment mechanism arrangement that remains in effect for 24 months after the end of the agreement period. See Medicare Shared Savings Program & Medicare ACO Track 1+ Model, Repayment Mechanism Arrangements, Guidance Document (July 2017, version #6), available at https://www.cms.gov/Medicare/ Medicare-Fee-for-Service-Payment/ sharedsavingsprogram/Downloads/ Repayment-Mechanism-Guidance.pdf (herein Repayment Mechanism Arrangements Guidance). In the August 2018 proposed rule (83 FR 41856), we noted that ACOs that started a first or second agreement period on January 1, 2016, in a twosided model would have in place under current program policies a repayment mechanism arrangement that would cover the 3 years between January 1, 2016 and December 31, 2018, plus a 24month tail period until December 31, 2020. We would expect an ACO with an agreement period ending December 31, 2018, that extends its agreement for the 6-month performance year from January 1, 2019 through June 30, 2019, to likewise extend the term of its repayment mechanism so that it will be in effect for the duration of the ACO’s participation in a two-sided model plus 24 months following the conclusion of the agreement period (that is, until June 30, 2021). This would allow us sufficient time to perform financial calculations for the 6-month performance year from January 1, 2019 through June 30, 2019, and to use the arrangement to collect shared losses for that performance year, if necessary. In a forthcoming final rule, we expect to summarize and respond to comments on our proposed changes to § 425.204(f) regarding repayment mechanism requirements for ACOs that are in a twosided model. Comment: One commenter expressed concern over the lack of current guidance on the required amount of a repayment mechanism arrangement (particularly for Track 1+ Model ACOs) and on how to execute changes to an existing repayment mechanism arrangement in order to support an ACO’s participation during the 6-month performance year from January 1, 2019 through June 30, 2019. The commenter also indicated that changing repayment mechanism amounts mid-year would likely result in extra costs to an ACO. Response: We appreciate the commenter’s concern. We may require a VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 Track 1+ Model ACO to adjust its repayment mechanism amount if, during the ACO’s agreement period, changes in the ACO’s participant composition occur that result in the application of a relatively higher or lower loss sharing limit. For example, if a Track 1+ Model ACO reports changes to its composition during the annual certification process in advance of the next performance year, and we determine that the ACO no longer qualifies for a revenue-based loss sharing limit, we may require the ACO to demonstrate that its repayment mechanism is sufficient to support losses for a higher amount under a benchmark-based loss sharing limit (83 FR 41841). We will notify an ACO if there is a significant change in its repayment mechanism amount warranting modification of its repayment mechanism arrangement and will specify the process for submitting to us revised repayment mechanism arrangement documentation for review. With regard to ACOs participating under Track 2 or Track 3, we clarify that, for the 6-month performance year from January 1, 2019 through June 30, 2019, we will not require any such ACO that elects to extend its participation agreement for such performance year to modify the amount we previously approved for the ACO’s repayment mechanism arrangement. In addition, we have notified ACOs participating under a two-sided model that if they elect the 6-month extension from January 1, 2019 through June 30, 2019 then we expect that they will extend their repayment mechanisms in accordance with § 425.204(f)(4). As we noted in our Repayment Mechanism Arrangements Guidance, we would consider § 425.204(f)(4) to be satisfied by a repayment mechanism arrangement that remains in effect for 24 months after the end of the agreement period. Accordingly, an ACO participating under a two-sided model that elects the 6-month extension from January 1, 2019 through June 30, 2019, should extend the term of its repayment mechanism until June 30, 2021. We acknowledge that amending certain repayment mechanism arrangements could come at additional costs to ACOs. However, we believe it necessary that the repayment mechanism arrangements comply with Shared Savings Program and Track 1+ Model policy to ensure the ACO can repay losses for which it may be liable. (4) Quality Reporting and Quality Measure Sampling As described in the August 2018 proposed rule (83 FR 41856 through PO 00000 Frm 00119 Fmt 4701 Sfmt 4700 59953 41858), to determine an ACO’s quality performance for the 6-month performance year from January 1, 2019 through June 30, 2019, we proposed to use the ACO’s quality performance for the 2019 reporting period as determined under § 425.502. Under this proposed approach, we would account for the ACO’s quality performance using quality measure data reported for the 12-month CY 2019. As we explained in the August 2018 proposed rule, the following considerations support this proposed approach. For one, use of a 12-month period for quality measure assessment maintains alignment with the program’s existing quality measurement approach, and aligns with the proposed use of 12 months of expenditure data (for CY 2019) in determining the ACO’s financial performance. Also, this approach would continue to align the program’s quality reporting period with policies under the Quality Payment Program. ACO professionals that are MIPS eligible clinicians (not QPs based on their participation in an Advanced APM or otherwise excluded from MIPS) would continue to be scored under MIPS using the APM scoring standard that covers all of 2019. Second, the measure specifications for the quality measures used under the program require 12 months of data. See for example, the Shared Savings Program ACO 2018 Quality Measures Narrative Specification Document (January 20, 2018), available at https://www.cms.gov/ Medicare/Medicare-Fee-for-ServicePayment/sharedsavingsprogram/ Downloads/2018-reporting-yearnarrative-specifications.pdf. Third, in light of our proposal to use 12 months of expenditures (based on CY 2019) in determining shared savings and shared losses for a 6-month performance year, it would also be appropriate to hold ACOs accountable for the quality of the care furnished to their assigned beneficiaries during this same timeframe. Fourth, and lastly, using an annual quality reporting cycle for the 6month performance year would avoid the need to introduce new reporting requirements, and therefore, potential additional burden on ACOs. The ACO participant list is used to determine beneficiary assignment for purposes of generating the quality reporting samples. Beneficiary assignment is performed using the applicable assignment methodology under § 425.400, either preliminary prospective assignment or prospective assignment, with excluded beneficiaries removed under § 425.401(b), as applicable. The samples for claimsbased measures are typically E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59954 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations determined based on the assignment list for calendar year quarter 4. The sample for quality measures reported through the CMS Web Interface is typically determined based on the beneficiary assignment list for calendar year quarter 3. The CAHPS for ACOs survey sample is typically determined based on the beneficiary assignment list for calendar year quarter 2. For purposes of determining the quality reporting samples for the 2019 reporting period, we proposed to use the ACO’s most recent certified ACO participant list available at the time the quality reporting samples are generated, and the assignment methodology most recently applicable to the ACO for a 2019 performance year. We explained our belief that the use of the ACO’s most recent certified ACO participant list to assign beneficiaries according to the assignment methodology applicable based on the ACO’s most recent participation in the program during 2019 would result in the most relevant beneficiary samples for 2019 quality reporting. Additionally, we believed this proposed approach to determining the ACO’s quality reporting samples was also appropriate for an ACO that participated in only one 6-month performance year during 2019 because the most recent certified ACO participant list applicable for the performance year would also be the certified ACO participant list that is used to determine financial performance. We proposed two approaches to determine the certified ACO participant list, assignment methodology, and assignment window that would be used to generate the quality reporting samples for measuring quality performance of ACOs participating in the 6-month performance year from January 1, 2019 through June 30, 2019. One approach was applicable to ACOs that enter a new agreement period under the proposed July 1, 2019 agreement start date, including ACOs that extended their prior participation agreement for the 6-month performance year from January 1, 2019, to June 30, 2019. For ACOs that enter a new agreement period beginning on July 1, 2019, we proposed to use the certified ACO participant list for the performance year starting on July 1, 2019, to determine the quality reporting samples for the 2019 reporting period. This most recent certified ACO participant list would therefore be used to determine the quality reporting samples for the 2019 reporting year. A second approach was proposed for an ACO that extends its participation for the first 6 months of 2019, but does not enter a new VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 agreement period beginning on the proposed July 1, 2019 agreement start date. This second approach is relevant to the policies we are finalizing in this final rule, for the 6-month performance year from January 1, 2019 through June 30, 2019, for ACOs whose current participation agreements expire on December 31, 2018, and that voluntarily elect to extend their agreement period for a fourth performance year. Under this approach, we proposed to use the ACO’s latest certified participant list (the ACO participant list effective on January 1, 2019) to determine the quality reporting samples for the 2019 reporting period. Beneficiary assignment for purposes of generating the quality reporting samples would be based on the assignment methodology applicable to the ACO during its 6month performance year from January 1, 2019 through June 30, 2019, under § 425.400, either preliminary prospective assignment or prospective assignment, with excluded beneficiaries removed under § 425.401(b), as applicable. We anticipated that the assignment windows for the quality reporting samples would be as follows, based on our operational experience: (1) Samples for claims-based measures would be determined based on the assignment list for calendar year quarter 4; (2) the sample for CMS Web Interface measures would be determined based on the assignment list for calendar year quarter 3; and (3) the sample for the CAHPS for ACOs survey would be determined based on the assignment list for calendar year quarter 2. We noted that this approach would maintain alignment with the assignment windows currently used for establishing quality reporting samples for these measures. We proposed to specify the certified ACO participant list that would be used in determining the quality reporting samples for measuring quality performance for the 6-month performance year from January 1, 2019 through June 30, 2019, in a new section of the regulations at § 425.609(b). Comment: Some commenters requested clarification about how quality reporting will take place for 6month performance periods based on 12 months of data. Specifically, these commenters stated their assumption that all ACOs would only be responsible for reporting quality one time, during the typical January to March timeframe following the end of 2019. One commenter expressed concern that the proposed approach for two 6-month performance years and two financial reconciliations for performance years in CY 2019 would also require two separate quality reporting samples for PO 00000 Frm 00120 Fmt 4701 Sfmt 4700 measures reported through the CMS Web Interface. The commenter was concerned about the burden that would be imposed on ACOs by such a requirement, given that annual quality reporting requires a significant amount of ACO resources. Response: We proposed to determine quality performance for the 6-month performance years during 2019 based on an ACO’s quality performance during the 12-month CY 2019 in order to align with the program’s existing quality reporting methodology, measure specifications which require 12-months of data, and the APM scoring standard under MIPS. In addition, because we proposed to use quality performance during all of CY 2019, we proposed that ACOs would only have to report quality once for CY 2019, regardless of whether they complete their participation in the program following the conclusion of the 6-month performance year from January 1, 2019 through June 30, 2019, or they renew for a new agreement period beginning on July 1, 2019 (if finalized as proposed). Therefore, ACOs participating in the 6-month performance year from January 1, 2019 through June 30, 2019, and the 6-month performance year from July 1, 2019 through December 31, 2019 (if finalized as proposed), would report quality for one beneficiary sample for CY 2019. We also note that for the 2019 reporting period, ACOs would be required to report quality data through the CMS Web Interface, according to the method and timing of submission established by CMS. The period for reporting quality data through the CMS Web Interface typically occurs for a 12week period between January and March, following the conclusion of the calendar year. Thus, ACOs that participate in a 6-month performance year from January 1, 2019 through June 30, 2019, along with all other Shared Savings Program ACOs would be required to report for the 2019 reporting period, and would report quality data through the CMS Web Interface during the designated reporting period in early 2020. Further, ACOs participating in the 6-month performance year from January 1, 201 through June 30, 2019, would be required to contract with a CMSapproved vendor to administer the CAHPS for ACOs survey for the 2019 reporting period, consistent with program-wide policies applicable to all other ACOs. We would apply the program’s sampling methodology, as we have described in the August 2018 proposed rule and this section of this final rule, to determine the beneficiaries eligible for the samples for claims-based measures (as calculated by CMS), CMS E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations amozie on DSK3GDR082PROD with RULES3 Web Interface reporting, and the CAHPS for ACOs survey. After consideration of the comments, we are finalizing without modification our proposal to determine an ACO’s quality performance for the 6-month performance year from January 1, 2019 through June 30, 2019, using the ACO’s quality performance for the 12-month CY 2019 (2019 reporting period) as determined under § 425.502. We are also finalizing a subset of our proposals for identifying the ACO participant list used in determining quality reporting samples for ACOs participating in a 6month performance year from January 1, 2019 through June 30, 2019. Given the limited scope of this final rule we are finalizing our proposal to use an ACO’s latest certified ACO participant list for the performance year from January 1, 2019 through June 30, 2019, (the ACO participant list effective on January 1, 2019) to determine the quality reporting samples for the 2019 reporting period. We are not addressing at this time our proposals related to the proposed July 1, 2019 agreement start date, including the policies for determining the quality reporting samples for ACOs that extend their participation agreement for the 6month performance year from January 1, 2019 through June 30, 2019, and continue their participation in the program in a new agreement period beginning on July 1, 2019. We anticipate summarizing and responding to comments received on these proposals in a forthcoming final rule. (5) Applicability of Extreme and Uncontrollable Circumstances Policies In section II.E.4 of the August 2018 proposed rule (83 FR 41899 through 41906), we proposed to extend the policies for addressing the impact of extreme and uncontrollable circumstances on ACO financial and quality performance results for performance year 2017 to performance year 2018 and subsequent years. As discussed in section V.B.2.d of this final rule, we are finalizing this proposal. In section II.E.4. of the August 2018 proposed rule, we indicated that if finalized, these policies would apply to ACOs participating in the 6-month performance year from January 1, 2019 through June 30, 2019. There were no comments directed specifically at our proposals with respect to the applicability of these policies for addressing the impact of extreme and uncontrollable circumstances on ACOs participating in a 6-month performance year from January 1, 2019 through June 30, 2019. We direct readers to review section V.B.2.d. of this final rule, for a more VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 comprehensive discussion of the modifications to the program’s extreme and uncontrollable circumstances policies that we are finalizing with this final rule. We are finalizing as proposed the policies for determining the financial and quality performance for the 6month performance year from January 1, 2019 through June 30, 2019, for ACOs affected by extreme and uncontrollable circumstances during CY 2019. In addition, we are also finalizing our proposal to specify, in a new section of the regulations at § 425.609(d), the following policies related to determining the financial and quality performance for the 6-month performance year from January 1, 2019 through June 30, 2019, for an ACO affected by extreme and uncontrollable circumstances during CY 2019: (1) In calculating the amount of shared losses owed by the ACO, CMS makes adjustments to the amount determined under § 425.609(b), as specified in § 425.606(i) (Track 2) or § 425.610(i) (Track 3), as applicable; and (2) in determining the ACO’s quality performance score for the 2019 quality reporting period, CMS uses the alternative scoring methodology specified in § 425.502(f). (6) Payment and Recoupment for 6Month Performance Years In the August 2018 proposed rule (83 FR 41858), we proposed policies regarding CMS’ notification to ACOs of shared savings and shared losses and the timing for ACOs’ repayment of shared losses for both the 6-month performance year (or performance period) from January 1, 2019 through June 30, 2019, and the 6-month performance year from July 1, 2019 through December 31, 2019. In this final rule, we are addressing the proposals specific to the 6-month performance year from January 1, 2019 through June 30, 2019. In a forthcoming final rule, we anticipate discussing comments received on the proposals related to payment and recoupment for the 6-month performance year from July 1, 2019 through December 31, 2019, and the performance period from January 1, 2019 through June 30, 2019, for ACOs that terminate their agreement effective June 30, 2019, and enter a new agreement period starting on July 1, 2019. We anticipate this final rule would include a discussion of our proposal to reduce the shared savings payment for one 6-month performance year (or performance period) by the amount of any shared losses owed for the other 6-month performance year (or performance period). PO 00000 Frm 00121 Fmt 4701 Sfmt 4700 59955 In the August 2018 proposed rule, we proposed that the following policies would be applicable to ACOs that elect a 6-month extension for the performance year from January 1, 2019 through June 30, 2019. Because we proposed to perform financial reconciliation for this 6-month performance year after the end of CY 2019, we anticipated that financial performance reports for the 6-month performance year would be available in Summer 2020, similar to the expected timeframe for issuing financial performance reports for the 12-month 2019 performance year (and for 12month performance years generally). We proposed to apply the same policies regarding notification of shared savings and shared losses and the timing of repayment of shared losses to ACOs in a 6-month performance year that apply under our current regulations to ACOs in 12-month performance years. For the 6-month performance year from January 1, 2019 through June 30, 2019, we proposed to specify in a new regulation at § 425.609 that CMS would notify the ACO of shared savings or shared losses, consistent with the notification requirements specified in § 425.604(f) (Track 1), § 425.606(h) (Track 2), and § 425.610(h) (Track 3). Specifically, we proposed that the following approach: (1) CMS notifies an ACO in writing regarding whether the ACO qualifies for a shared savings payment, and if so, the amount of the payment due; (2) CMS provides written notification to an ACO of the amount of shared losses, if any, that it must repay to the program; (3) if an ACO has shared losses, the ACO must make payment in full to CMS within 90 days of receipt of notification. We proposed to specify policies on payment and recoupment for ACOs in a 6-month performance year during CY 2019 in a new section of the regulations at § 425.609(e). Comment: Some commenters urged CMS to provide additional guidance and education to ACOs on whether there will be any disruptions in providing performance results to ACOs participating in a 6-month performance year in CY 2019. Response: We anticipate determining financial and quality performance for ACOs participating in the 6-month performance year from January 1, 2019 through June 30, 2019, according to the typical annual projected timeline for making these determinations, and for issuing performance reports to ACOs. The ACO’s annual financial reconciliation report, quality performance reports, and additional informational reports and files, are E:\FR\FM\23NOR3.SGM 23NOR3 59956 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations amozie on DSK3GDR082PROD with RULES3 typically made available in the summer following the conclusion of a 12-month performance year. We also plan to provide ACOs that participate in the 6month performance year from January 1, 2019 through June 30, 2019, quarterly reports for the third and fourth quarter of CY 2019 (see discussion in section V.B.1.c.(8) of this final rule). We anticipate that we will make available to ACOs an annual schedule for report delivery for 2019. For example, see the 2018 Shared Savings Program report schedule included as Table 12 in the Medicare Shared Savings Program, Shared Savings and Losses and Assignment Methodology Specifications (May 2018, version 6) available at https://www.cms.gov/Medicare/ Medicare-Fee-for-Service-Payment/ sharedsavingsprogram/programguidance-and-specifications.html. We are finalizing without modification our proposal to specify in a new section of the regulations at § 425.609(e) that CMS will notify the ACO of shared savings or shared losses for the 6-month performance year from January 1, 2019 through June 30, 2019, consistent with the notification requirements specified in §§ 425.604(f), 425.606(h), and 425.610(h), as applicable. Specifically, we will notify an ACO in writing regarding whether the ACO qualifies for a shared savings payment, and if so, the amount of the payment due. CMS will provide written notification to an ACO of the amount of shared losses, if any, that the ACO must repay to the program. If an ACO has shared losses, the ACO must make payment in full to CMS within 90 days of receipt of notification. (7) Interactions With the Quality Payment Program In the August 2018 proposed rule (83 FR 41859), we took into consideration how the proposed July 1, 2019 start date could interact with other Medicare initiatives, particularly the Quality Payment Program timelines relating to participation in APMs. In the CY 2018 Quality Payment Program final rule with comment period, we finalized a policy for APMs that start or end during the QP Performance Period. Specifically, under § 414.1425(c)(7)(i), for Advanced APMs that start during the QP Performance Period and are actively tested for at least 60 continuous days during a QP Performance Period, CMS will make QP determinations and Partial QP determinations for eligible clinicians in the Advanced APM using claims data for services furnished during those dates on which the Advanced APM is actively tested. CMS performs QP determinations for eligible VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 clinicians in an APM entity three times during the QP Performance Period using claims data for services furnished from January 1 through each of the respective QP determination dates: March 31, June 30, and August 31 (§ 414.1425(b)(1)). We explained that this meant that an APM (such as a two-sided model of the Shared Savings Program) would need to begin operations by July 1 of a given performance year in order to be actively tested for at least 60 continuous days before August 31—the last date on which QP determinations are made during a QP Performance Period (as specified in § 414.1425(b)(1)). Therefore, we believed that our proposed July 1, 2019 start date for the proposed new participation options under the Shared Savings Program would align with Quality Payment Program rules and requirements for participation in Advanced APMs. However, we did not address QP determinations for eligible clinicians participating in an ACO whose agreement period expires on December 31, 2018, that elects a voluntary extension for the 6-month performance year from January 1, 2019 through June 30, 2019, and does not continue in the program past June 30, 2019. Further, as described in section II.A.7.c.(4) of the August 2018 proposed rule (83 FR 41856), our proposal to use a 12-month period for quality measure assessment for either 6-month performance year during 2019 would maintain alignment with the program’s existing quality measurement approach, and align with the proposed use of 12 months of expenditure data (for CY 2019) in determining the ACO’s financial performance for a 6-month performance year. Also, this approach would continue to align the program’s quality reporting period with policies under the Quality Payment Program (83 FR 41856). We explained that ACO professionals that are MIPS eligible clinicians (not QPs based on their participation in an Advanced APM or otherwise excluded from MIPS) would continue to be scored under MIPS using the APM scoring standard that covers all of 2019. Comment: One commenter indicated that, as proposed, it appears ACOs in a two-sided model may lose Advanced APM Entity status and sought clarity on the Advanced APM status for all participating ACOs. This commenter was specifically concerned about the Advanced APM status of the Track 1+ Model. Response: We believe the comment reflects the need for clarification about whether eligible clinicians in an ACO that is participating in a track that meets PO 00000 Frm 00122 Fmt 4701 Sfmt 4700 the Advanced APM criteria and that elects to extend for the 6-month performance year from January 1, 2019 through June 30, 2019, but does not continue its participation in the Shared Savings Program past June 30, 2019, would be eligible to become QPs during the 2019 QP Performance Period. Eligible clinicians who become QPs will earn the Advanced APM incentive payment and will not be subject to the MIPS reporting requirements and payment adjustments for the applicable year. The commenter may have been concerned that an agreement period that ends prior to the end of the QP performance period (August 31, 2019) would be considered an early termination and that the ACO would therefore lose its status as participating in an Advanced APM, which is not the case under our previously-finalized policy for Advanced APMs that start or end during a performance period. For an ACO that is in a track that meets the Advanced APM criteria and elects to extend for the 6-month performance year from January 1, 2019 through June 30, 2019, the agreement period would end during the QP performance period. However, because the ACO would have been active for more than 60 days, it would continue to be an APM entity in an Advanced APM in 2019 (§ 414.1425(c)(7)). Therefore, clinicians who obtain QP status based on the March 31, 2019, or June 30, 2019 snapshot through participation in an ACO with a 6-month extension of its agreement period will: Maintain QP status, be exempt from MIPS, and receive the APM incentive payment, as long as their ACO completes its agreement period by remaining in the program through June 30, 2019. We also believe there is a need to clarify what happens to an eligible clinician’s QP status if they are participating in an ACO that is in a track that meets the Advanced APM criteria and elects to extend for the 6-month performance year from January 1, 2019 through June 30, 2019, and either voluntarily terminates or is involuntarily terminated prior to June 30, 2019. If their ACO terminates or is involuntarily terminated any time after March 31, 2019, and before August 31, 2019, then eligible clinicians previously determined to have had QP status would lose their status as a result of the termination, and would instead be scored under MIPS using the APM Scoring Standard (§ 414.1425(c)(5) and (6)). If their ACO terminates before March 31, 2019, then the eligible clinicians would not be scored under the APM Scoring Standard and will be E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations assessed under regular MIPS scoring rules (§§ 414.1370(e) and 414.1425(b)(1)). Comment: Some commenters requested clarification on how quality reporting for a 6-month performance period based on 12-months of data for 2019 will satisfy the MIPS quality reporting requirements for MIPS eligible clinicians in ACOs that elect to extend their participation agreement for the 6month performance year from January 1, 2019 through June 30, 2019. One commenter indicated there was no discussion of how the proposed 6month extension period would impact scoring under the APM scoring standard. Response: We believe the comments reflect the need for clarification about whether 2019 quality performance for a 6-month performance year under the Shared Savings Program will count the same as a full year of performance for purposes of the APM scoring standard if the ACO ends its current agreement period at the end of the 6-month extension and chooses to not renew its agreement with a July 1, 2019 start date (if finalized as proposed). That is, would the 2019 quality reporting for the 6month performance year count toward the final MIPS score in the same way that it would for an ACO that is participating in a full 12-month performance year in the program. As discussed in this section of this final rule, we are finalizing a policy of using a 12-month period for quality performance assessment for the 6-month performance year from January 1, 2019 through June 30, 2019, in order to maintain alignment with the program’s existing quality measurement approach, and with policies under the Quality Payment Program. ACO professionals that are MIPS eligible clinicians (not QPs based on their participation in an Advanced APM or otherwise excluded from MIPS) participating in an ACO that completes a 6-month performance year from January 1, 2019 through June 30, 2019, would continue to be scored under MIPS using the APM Scoring Standard, based on quality data submitted for all of 2019 during the regular submission period in early 2020. Thus, for a Track 1 ACO in a 6-month performance year from January 1, 2019 through June 30, 2019, whose agreement period expires and the ACO does not renew to continue program participation, the ACO would be scored under the MIPS APM scoring rules for quality reporting based on the entire CY 2019. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 (8) Sharing CY 2019 Aggregate Data With ACOs in 6-Month Performance Year From January 1, 2019 Through June 30, 2019 Under the program’s current regulations at § 425.702, we share aggregate data with ACOs during the agreement period. This includes providing data at the beginning of each performance year, during each quarter, and in conjunction with the annual reconciliation. In the August 2018 proposed rule (83 FR 41859), for ACOs that started a first or second agreement period on January 1, 2016, that extend their agreement for an additional 6month performance year from January 1, 2019 through June 30, 2019, we proposed to continue to deliver aggregate reports for all four quarters of CY 2019 based on the ACO participant list in effect for the 6-month performance year. This would give ACOs a more complete understanding of the Medicare FFS beneficiary population that is the basis for reconciliation for the 6-month performance year by allowing them to continue to receive data, including demographic characteristics and expenditure/utilization trends for their assigned population for the entire calendar year. We believed this proposed approach would allow us to maintain transparency by providing ACOs with data that relates to the entire period for which the expenditures for the beneficiaries assigned to the ACO for the 6-month performance year would be compared to the ACO’s benchmark (before pro-rating any shared savings or shared losses to reflect the length of the performance year), and maintain consistency with the reports delivered to ACOs that participate in a 12-month performance year 2019. Otherwise, we could be limited to providing ACOs with aggregate reports only for the first and second quarters of 2019, even though under our proposed methodology for assessing the financial performance of ACOs in a 6-month performance year, the financial reconciliation for the 6-month performance year would involve consideration of expenditures from outside this period during 2019. We proposed to specify this policy in revisions to § 425.702. Comment: Some commenters urged CMS to provide additional guidance and education to ACOs on whether there will be any disruptions in sharing claims files with ACOs participating in a 6-month performance year in CY 2019. Response: In the August 2018 proposed rule, we did not describe in detail the applicability of the program’s PO 00000 Frm 00123 Fmt 4701 Sfmt 4700 59957 policies on sharing beneficiaryidentifiable claims data with ACOs under § 425.704. We proposed, generally, that unless otherwise stated, program requirements under 42 CFR part 425 that are applicable to the ACO under the ACO’s chosen participation track and based on the ACO’s agreement start date would be applicable to an ACO participating in a 6-month performance year. Therefore, we would continue to provide beneficiaryidentifiable claims data (referred to as claim and claim line feed files) to ACOs only during their participation in the program, including during the 6-month performance year from January 1, 2019 through June 30, 2019. ACOs would receive monthly Part A, B and D claim and claim line feed files during the 6month performance year based on the ACO participant list they certify before the start of the performance year. Consistent with the program’s current data sharing policies, we would discontinue delivery of beneficiaryidentifiable data to ACOs when their participation agreement is no longer in effect. After consideration of the comments received, we are finalizing our proposal to deliver to ACOs participating in a 6-month performance year from January 1, 2019 through June 30, 2019, aggregate reports for all four quarters of CY 2019 based on the ACO participant list in effect for the performance year. This policy is specified in revisions to § 425.702. (9) Technical or Conforming Changes To Allow for 6-Month Performance Years In the August 2018 proposed rule (83 FR 41859 through 41860), we proposed to make certain technical, conforming changes to certain provisions of the regulations, including additional changes to provisions discussed elsewhere in the proposed rule, to reflect our proposal to add a new provision at § 425.609 to govern the calculation of the financial and quality results for the proposed 6-month performance years within CY 2019. In this final rule, we are addressing only the proposals specific to the 6-month performance year from January 1, 2019 through June 30, 2019. In a forthcoming final rule, we anticipate discussing comments received on the proposed 6-month performance year from July 1, 2019 through December 31, 2019, and the proposed 6-month performance period from January 1, 2019 through June 30, 2019, for ACOs that terminate their agreement effective June 30, 2019, and enter a new agreement period starting on July 1, 2019. E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59958 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations The following proposals discussed in the August 2018 proposed rule would be applicable to ACOs that elect a 6-month extension for the performance year from January 1, 2019 through June 30, 2019. Our proposal that the policies on reopening determinations of shared savings and shared losses to correct financial reconciliation calculations (§ 425.315) would apply with respect to applicable payment determinations for performance years within CY 2019. To clarify, we proposed to amend § 425.315 to incorporate a reference to the proposed provision for notification of shared savings and shared losses for ACOs in a 6-month performance year within CY 2019, as specified in § 425.609(e). Our proposal to add a reference to § 425.609 in § 425.100 in order to include ACOs that participate in a 6-month performance year during 2019 in the general description of ACOs that are eligible to receive payments for shared savings under the program. Our proposal to amend § 425.400(a)(1)(ii), which describes the step-wise process for determining beneficiary assignment for each performance year, to specify that this process would apply to ACOs participating in a 6-month performance year within CY 2019, and that assignment would be determined based on the beneficiary’s utilization of primary care services during the entirety of CY 2019, as specified in § 425.609. Our proposal to further revise § 425.400(c)(1)(iv), on the use of certain Current Procedural Terminology (CPT) codes and Healthcare Common Procedure Coding System (HCPCS) codes in determining beneficiary assignment, to specify that it would be used in determining assignment for performance years starting on January 1, 2019, and subsequent years. We note that we also proposed certain other revisions to this provision in section II.E.3. of the August 2018 proposed rule (83 FR 41896), as discussed in section V.B.2.c. of this final rule. Our proposal to revise § 425.401(b), describing the exclusion of beneficiaries from an ACO’s prospective assignment list at the end of a performance year or benchmark year and quarterly during each performance year, to specify that these exclusions would occur at the end of CY 2019 for purposes of determining assignment to an ACO in a 6-month performance year in accordance with §§ 425.400(a)(3)(ii) and 425.609. Our proposal, as part of the proposed revisions to § 425.402(e)(2), which, as described in section II.E.2. of the August 2018 proposed rule (83 FR 41894), VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 specifies that beneficiaries who have designated a provider or supplier outside the ACO as responsible for coordinating their overall care will not be added to the ACO’s list of assigned beneficiaries for a performance year under the claims-based assignment methodology, to allow the same policy to apply to ACOs participating in a 6-month performance year during CY 2019. We are finalizing our proposed revisions to § 425.402(e)(2), as described in section V.B.2.b. of this final rule. Our proposal to revise § 425.404(b), on the special assignment conditions for ACOs that include FQHCs and RHCs that provide services used in determining beneficiary assignment, to specify its applicability in determining assignment for performance years starting on January 1, 2019, and subsequent performance years. We also proposed to incorporate references to § 425.609 in the regulations that govern establishing, adjusting, and updating the benchmark, including the existing provisions at §§ 425.602 and 425.603, to specify that the annual risk adjustment and update to the ACO’s historical benchmark for the 6-month performance year from January 1, 2019 through June 30, 2019, would use factors based on the entirety of CY 2019. For clarity and simplicity, we proposed to add a paragraph to each of these sections to explain the following: (1) Regarding the annual risk adjustment applied to the historical benchmark, when CMS adjusts the benchmark for the 6-month performance year from January 1, 2019 through June 30, 2019, the adjustment will reflect the change in severity and case mix between benchmark year 3 and CY 2019; (2) Regarding the annual update to the historical benchmark, when CMS updates the benchmark for the 6-month performance year from January 1, 2019 through June 30, 2019, the update to the benchmark will be based on growth between benchmark year 3 and CY 2019. We also proposed to incorporate references to § 425.609 in the following provisions regarding the calculation of shared savings and shared losses: §§ 425.604, 425.606, and 425.610. For clarity and simplicity, we proposed to add a paragraph to each of these sections explaining that shared savings or shared losses for the 6-month performance year from January 1, 2019 through June 30, 2019, are calculated as described in § 425.609. That is, all calculations will be performed using CY 2019 data in place of performance year data. There were no comments directed specifically at our proposed technical PO 00000 Frm 00124 Fmt 4701 Sfmt 4700 and conforming changes to allow for 6-month performance years. We are finalizing as proposed the technical and conforming changes to the Shared Savings Program regulations as previously described in this section of this final rule, to allow them to apply to ACOs participating in a 6-month performance year from January 1, 2019 through June 30, 2019. (10) Payment Consequences of Early Termination In the August 2018 proposed rule (83 FR 41845 through 41847), we proposed policies to govern the payment consequences of early termination for performance years beginning in 2019 and subsequent years, including for ACOs participating in 6-month performance years from January 1, 2019 through June 30, 2019, and July 1, 2019 through December 31, 2019, as well as for ACOs participating in 12-month performance years. We proposed to impose payment consequences for early termination by holding ACOs in twosided models liable for pro-rated shared losses. This approach would apply to ACOs that voluntarily terminate their participation more than midway through a 12-month performance year and all ACOs that are involuntarily terminated by CMS. ACOs would be ineligible to share in savings for a performance year if the effective date of their termination from the program is prior to the last calendar day of the performance year; but, we would allow an exception for ACOs that are participating in a 12-month performance year under the program as of January 1, 2019, that terminate their agreement with an effective date of June 30, 2019, and enter a new agreement period under the proposed BASIC track or ENHANCED track beginning July 1, 2019. In these cases, we would perform separate reconciliations to determine shared savings and shared losses for the ACO’s first 6 month period of participation in 2019 and for the ACO’s 6-month performance year from July 1, 2019, to December 31, 2019, under the subsequent participation agreement. In a forthcoming final rule we anticipate addressing comments received on proposals for the payment consequences of early termination from 12-month performance years and from 6-month performance years beginning on July 1, 2019, should we finalize the proposal to offer a July 1, 2019 start date for the new participation options. Therefore, in this section of this final rule we focus specifically on the proposals regarding the payment consequences of early termination as they relate to the 6-month performance E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations year from January 1, 2019 through June 30, 2019. We proposed that an ACO would be eligible to receive shared savings for a 6-month performance year during 2019 if it completes the term of the performance year, regardless of whether the ACO chooses to continue its participation in the program. That is, we would reconcile ACOs that started a first or second agreement period January 1, 2016, that extend their agreement period for a fourth performance year, and complete this performance year (concluding on June 30, 2019). For an ACO that participates for a portion of a 6-month performance year during 2019, we proposed the following: (1) If the ACO terminates its participation agreement effective before the end of the performance year, we would not reconcile the ACO for shared savings or shared losses (if a two-sided model ACO); (2) if CMS terminates a two-sided model ACO’s participation agreement effective before the end of the performance year, the ACO would not be eligible for shared savings and we would reconcile the ACO for shared losses and pro-rate the amount reflecting the number of months during the performance year that the ACO was in the program. We proposed to specify these policies in amendments to § 425.221(b). We also proposed to revise the regulation at § 425.221 to streamline and reorganize the provisions in paragraph (b), which we believed necessary to incorporate the proposed new requirements. We sought comment on these proposals. We are not addressing our proposed modifications to program policies to impose payment consequences for early termination in this final rule. Accordingly, for ACOs participating in a performance year starting on January 1, 2019, we will continue to apply the program’s current policies for payment consequences of early termination. We believe that continuing to use the current approach would be simpler, both from the standpoint of CMS as the regulatory entity and operator of the program, and for ACOs as regulated entities already familiar with the current policies. Under this approach, ACOs that terminate from a performance year starting on January 1, 2019, with an effective date of termination prior to the end of their performance year will not be eligible for shared savings or accountable for shared losses. At this time, we are finalizing a subset of our proposed policies for determining payment consequences of early termination, to account for ACOs participating in a 6-month performance VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 year from January 1, 2019 through June 30, 2019. Specifically, we are finalizing without modification our proposal that an ACO participating in a 6-month performance year from January 1, 2019 through June 30, 2019, is eligible for shared savings if the following conditions are met: CMS has designated or approved an effective date of termination that is the last calendar day of the performance year (June 30, 2019); the ACO has completed all close-out procedures specified in § 425.221(a) by the deadline specified by CMS (if applicable); and the ACO has satisfied the criteria for sharing in savings for the performance year. Consistent with our existing policies, if the participation agreement is terminated at any time by CMS under § 425.218, the ACO will not be eligible to receive shared savings for the performance year during which the termination becomes effective, and will not be accountable for any shared losses. Further, for an ACO participating in a 6-month performance year from January 1, 2019 through June 30, 2019, that elects to terminate early, we will apply the payment consequences of early termination consistent with the current regulations, and the ACO will not be eligible to receive shared savings for the performance year and will not be accountable for any shared losses. We are finalizing the proposed revisions to § 425.221 to allow us to consistently apply current program policies on the payment consequences of early termination or agreement expiration to ACOs in a 6-month performance year from January 1, 2019 through June 30, 2019. We are amending § 425.221(b) to remove references to December 31st of a performance year and instead to refer to the last calendar day of the performance year, so that the regulatory provisions will apply to ACOs regardless of whether they are participating in a 12-month or 6-month performance year. We are not addressing at this time the other proposed revisions to the regulation at § 425.221, including the proposals to streamline and reorganize the provisions in paragraph (b). 2. Updating Program Policies a. Overview This section addresses various proposed revisions described in the August 2018 proposed rule (83 FR 41894 through 41911) that are designed to update policies under the Shared Savings Program. We proposed to revise our regulations governing the assignment process in order to align our voluntary alignment policies with the requirements of section 50331 of the PO 00000 Frm 00125 Fmt 4701 Sfmt 4700 59959 Bipartisan Budget Act of 2018 and to update the definition of primary care services. We also proposed to extend the policies that we recently adopted for ACOs impacted by extreme and uncontrollable circumstances during 2017 to 2018 and subsequent performance years. We also solicited comment on considerations related to supporting ACOs’ activities to address the national opioid crisis and the agency’s meaningful measures initiative. We proposed to discontinue use of the quality performance measure that assesses the level of adoption of CEHRT by the eligible clinicians in an ACO and proposed instead that ACOs be required to certify upon application to participate in the Shared Savings Program and annually thereafter that the percentage of eligible clinicians participating in the ACO using CEHRT to document and communicate clinical care to their patients or other health care providers meets or exceeds certain thresholds. b. Revisions to Policies on Voluntary Alignment (1) Background Section 50331 of the Bipartisan Budget Act of 2018 amended section 1899(c) of the Act (42 U.S.C. 1395jjj(c)) to add a new paragraph (2)(B) that requires the Secretary, for performance year 2018 and each subsequent performance year, to permit a Medicare FFS beneficiary to voluntarily identify an ACO professional as the primary care provider of the beneficiary for purposes of assigning such beneficiary to an ACO, if a system is available for electronic designation. A voluntary identification by a Medicare FFS beneficiary under this provision supersedes any claimsbased assignment otherwise determined by the Secretary. Section 50331 also requires the Secretary to establish a process under which a Medicare FFS beneficiary is notified of his or her ability to designate a primary care provider or subsequently to change this designation. An ACO professional is defined under section 1899(h) of the Act as a physician as defined in section 1861(r)(1) of the Act and a practitioner described in section 1842(b)(18)(C)(i) of the Act. As we stated in the August 2018 proposed rule (83 FR 41894), we believe that section 50331 requires certain revisions to our current beneficiary voluntary alignment policies in § 425.402(e). Prior to enactment of the Bipartisan Budget Act of 2018, section 1899(c) of the Act required that beneficiaries be assigned to an ACO based on their use of primary care services furnished by a physician as E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59960 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations defined in section 1861(r)(1) of the Act, and beginning January 1, 2019, services provided in RHCs/FQHCs. In order to satisfy this statutory requirement, we currently require that a beneficiary receive at least one primary care service during the beneficiary assignment window from an ACO professional in the ACO who is a physician with a specialty used in assignment in order to be assigned to the ACO (see § 425.402(b)(1)). As currently provided in § 425.404(b), for performance year 2019 and subsequent performance years, for purposes of the assignment methodology in § 425.402, CMS treats a service reported on an FQHC/RHC claim as a primary care service performed by a primary care physician. After identifying the beneficiaries who have received a primary care service from a physician in the ACO, we use a twostep, claims-based methodology to assign beneficiaries to a particular ACO for a calendar year (see § 425.402(b)(2) through (4)). In the CY 2017 PFS final rule (81 FR 80501 through 80510), we augmented this claims-based beneficiary assignment methodology by finalizing a policy under which beneficiaries, beginning in 2017 for assignment for performance year 2018, may voluntarily align with an ACO by designating a ‘‘primary clinician’’ they believe is responsible for coordinating their overall care using MyMedicare.gov, a secure online patient portal. MyMedicare.gov contains a list of all of the Medicare-enrolled practitioners who appear on the Physician Compare website and beneficiaries may choose any practitioner present on Physician Compare as their primary clinician. Notwithstanding the assignment methodology in § 425.402(b), beneficiaries who designate an ACO professional whose services are used in assignment as responsible for their overall care will be prospectively assigned to the ACO in which that ACO professional participates, provided the beneficiary meets the eligibility criteria established at § 425.401(a) and is not excluded from assignment by the criteria in § 425.401(b), and has had at least one primary care service during the assignment window with an ACO professional in the ACO who is a primary care physician as defined under § 425.20 or a physician with one of the primary specialty designations included in § 425.402(c) (see § 425.402(e)). Such beneficiaries will be added prospectively to the ACO’s list of assigned beneficiaries for the subsequent performance year, superseding any assignment that might have otherwise occurred under the VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 claims-based methodology. Further, beneficiaries may change their designation at any time through MyMedicare.gov; the new choice will be incorporated when we perform assignment for the subsequent performance year. Beneficiaries who designate a provider or supplier outside an ACO, who is a primary care physician, a physician with a specialty designation that is considered in the assignment methodology, or a nurse practitioner, physician assistant, or clinical nurse specialist, as responsible for coordinating their overall care will not be added to an ACO’s list of assigned beneficiaries, even if they would otherwise meet the criteria for claims-based assignment. (2) Summary of Proposed Revisions Section 1899(c) of the Act, as amended by section 50331 of the Bipartisan Budget Act of 2018, requires the Secretary to permit a Medicare FFS beneficiary to voluntarily identify an ACO professional as their primary care provider for purposes of assignment to an ACO. Under our current methodology, a beneficiary may select any practitioner who has a record on the Physician Compare website as their primary clinician; however, we will only assign the beneficiary to an ACO if they have chosen a practitioner who is a primary care physician (as defined at § 425.20), a physician with one of the primary specialty designations included in § 425.402(c), or a nurse practitioner, physician assistant, or clinical nurse specialist. Therefore, we proposed to modify our current voluntary alignment policies at § 425.402(e)(2)(iii) to provide that we will assign a beneficiary to an ACO based upon their selection of any ACO professional, regardless of specialty, as their primary clinician. Under this proposal, a beneficiary may select a practitioner with any specialty designation, for example, a specialty of allergy/immunology or surgery, as their primary care provider and be eligible for assignment to the ACO in which the practitioner is an ACO professional. Specifically, we proposed to revise § 425.402(e)(2)(iii) to remove the requirement that the ACO professional designated by the beneficiary be a primary care physician as defined at § 425.20, a physician with a specialty designation included at § 425.402(c), or a nurse practitioner, physician assistant, or clinical nurse specialist. In addition, the provision at § 425.402(e)(2)(iv) addresses beneficiary designations of clinicians outside the ACO as their primary clinician. The current policy at § 425.402(e)(2)(iv) provides that a beneficiary will not be assigned to an PO 00000 Frm 00126 Fmt 4701 Sfmt 4700 ACO for a performance year if the beneficiary has designated a provider or supplier outside the ACO who is a primary care physician as defined at § 425.20, a physician with a specialty designation included at § 425.402(c), or a nurse practitioner, physician assistant, or clinical nurse specialist as their primary clinician responsible for coordinating their overall care. Consistent with the proposed revisions to § 425.402(e)(2)(iii) to incorporate the requirements of section 50331 of the Bipartisan Budget Act, we proposed to revise § 425.402(e)(2)(iv) to indicate that if a beneficiary designates any provider or supplier outside the ACO as their primary clinician responsible for coordinating their overall care, the beneficiary will not be added to the ACO’s list of assigned beneficiaries for a performance year. Section 1899(c) of the Act, as amended by section 50331 of the Bipartisan Budget Act of 2018, requires the Secretary to allow a beneficiary to voluntarily align with an ACO, and does not impose any restriction with respect to whether the beneficiary has received any services from an ACO professional (see section 1899(c)(2)(B)(i) of the Act). As we explained in the August 2018 proposed rule (83 FR 41895), we believe the requirement in section 1899(c)(2)(B)(iii) of the Act that a beneficiary’s voluntary identification shall supersede any claims-based alignment is also consistent with eliminating the requirement that the beneficiary have received a service from an ACO professional in order to be eligible to be assigned an ACO. Therefore, we proposed to remove the requirement at § 425.402(e)(2)(i) that a beneficiary must have received at least one primary care service from an ACO professional who is either a primary care physician or a physician with a specialty designation included in § 425.402(c) within the 12-month assignment window in order to be assigned to the ACO. Under this proposal, a beneficiary who selects a primary clinician who is an ACO professional, but who does not receive any services from an ACO participant during the assignment window, will remain eligible for assignment to the ACO. We stated that we believe this approach would reduce burden on beneficiaries and their practitioners by not requiring practitioners to provide unnecessary care during a specified period of time in order for a beneficiary to remain eligible for assignment to the ACO. Consistent with this proposal, we proposed to remove § 425.402(e)(2)(i) in its entirety. E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations We noted that, under this proposal, if a beneficiary does not change their primary clinician designation, the beneficiary will remain assigned to the ACO in which that practitioner participates during the ACO’s entire agreement period and any subsequent agreement periods under the Shared Savings Program, even if the beneficiary no longer seeks care from any ACO professionals. Because a beneficiary who has voluntarily identified a Shared Savings Program ACO professional as their primary care provider will remain assigned to the ACO regardless of where they seek care, this proposed change could also impact assignment under certain Innovation Center models in which overlapping beneficiary assignment is not permitted. As we explained in the August 2018 proposed rule (83 FR 41895), we believe our proposed policy is consistent with the requirement under section 1899(c)(2)(B)(iii) of the Act that a voluntary identification by a beneficiary shall supersede any claims-based assignment. However, we also believe it could be appropriate, in limited circumstances, to align a beneficiary to an entity participating in certain specialty and disease-specific Innovation Center models, such as the Comprehensive ESRD Care (CEC) Model. CMS implemented the CEC Model to test a new system of payment and service delivery that CMS believes will lead to better health outcomes for Medicare beneficiaries living with ESRD, while lowering costs to Medicare Parts A and B. Under the model, CMS is working with groups of health care providers, dialysis facilities, and other suppliers involved in the care of ESRD beneficiaries to improve the coordination and quality of care that these individuals receive. We believe that an ESRD beneficiary, who is otherwise eligible for assignment to an entity participating in the CEC Model, could benefit from the focused attention on and increased care coordination for their ESRD available under the CEC Model. Such a beneficiary could be disadvantaged if they were unable to receive the type of specialized care for their ESRD that will be available from an entity participating in the CEC Model. Furthermore, we believe it could be difficult for the Innovation Center to conduct a viable test of a specialty or disease-specific model, if we were to require that beneficiaries who have previously designated an ACO professional as their primary clinician remain assigned to the Shared Savings Program ACO under all circumstances. Currently, the CEC Model completes its VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 annual PY prospective assignment lists prior to the Shared Savings Program in order to identify the beneficiaries who may benefit from receiving specialized care from an entity participating in the CEC Model. Additionally, on a quarterly basis, a beneficiary may be assigned to the CEC Model who was previously assigned to a Track 1 or Track 2 ACO. As a result, we believe that in some instances it may be necessary for the Innovation Center to use its authority under section 1115A(d)(1) of the Act to waive the requirements of section 1899(c)(2)(B) of the Act solely as necessary for purposes of testing a particular model. Therefore, we proposed to create an exception to the general policy that a beneficiary who has voluntarily identified a Shared Savings Program ACO professional as their primary care provider will remain assigned to the ACO regardless of where they seek care. Specifically, we proposed that we would not assign such a beneficiary to the ACO when the beneficiary is also eligible for assignment to an entity participating in a model tested or expanded under section 1115A of the Act under which claims-based assignment is based solely on claims for services other than primary care services and for which there has been a determination by the Secretary that a waiver under section 1115A(d)(1) of the Act of the requirement in section 1899(c)(2)(B) of the Act is necessary solely for purposes of testing the model. Under this proposal, if a beneficiary selects a primary clinician who is a Shared Savings Program ACO professional and the beneficiary is also eligible for alignment to a specialty care or disease specific model tested or expanded under section 1115A of the Act under which claims-based assignment is based solely on claims for services other than primary care services and for which there has been a determination that a waiver of the requirement in section 1899(c)(2)(B) is necessary solely for purposes of testing the Model, the Innovation Center or its designee would notify the beneficiary of their alignment to an entity participating in the model. Additionally, although such a beneficiary may still voluntarily identify his or her primary clinician and may seek care from any clinician, the beneficiary would not be assigned to a Shared Savings Program ACO even if the designated primary clinician is an ACO professional in a Shared Savings Program ACO. In the August 2019 proposed rule (83 FR 41896), we indicated that we would include a list of any models that meet these criteria on the Shared Savings PO 00000 Frm 00127 Fmt 4701 Sfmt 4700 59961 Program website, to supplement the information already included in the beneficiary assignment reports we currently provide to ACOs (as described under § 425.702(c)), so that ACOs can know why certain beneficiaries, who may have designated an ACO professional as their primary clinician, are not assigned to them. Similar information would also be shared with 1–800–MEDICARE to ensure that Medicare customer service representatives are able to help beneficiaries who may be confused as to why they are not aligned to the ACO in which their primary clinician is participating. Section 1899(c)(2)(B)(ii) of the Act, as amended by section 50331 of the Bipartisan Budget Act, requires the Secretary to establish a process under the Shared Savings Program through which each Medicare FFS beneficiary is notified of the ability to identify an ACO professional as his or her primary care provider and informed of the process that may be used to make and change such identification. In the August 2018 proposed rule (83 FR 41896), we stated our intent to implement section 1899(c)(2)(B)(ii) of the Act under the beneficiary notification process at § 425.312. We are not addressing this topic at this time. We will summarize and respond to public comments on this proposed policy in a forthcoming final rule. We proposed to apply these modifications to our policies under the Shared Savings Program regarding voluntary alignment beginning for performance years starting on January 1, 2019, and subsequent performance years. We proposed to incorporate these new requirements in the regulations by redesignating § 425.402(e)(2)(i) through (iv) as § 425.402(e)(2)(i)(A) through (D), adding a paragraph heading for newly redesignated § 425.402(e)(2)(i), and including a new § 425.402(e)(2)(ii). We noted that as specified in § 425.402(e)(2)(ii) a beneficiary who has designated an ACO professional as their primary clinician must still be eligible for assignment to an ACO by meeting the criteria specified in § 425.401(a). These criteria establish the minimum requirements for a beneficiary to be eligible to be assigned to an ACO under our existing assignment methodology, and we believe it is appropriate to impose the same basic limitations on the assignment of beneficiaries on the basis of voluntary alignment. We do not believe it would be appropriate, for example, to assign a beneficiary to an ACO if the beneficiary does not reside in the United States, or if the other eligibility requirements are not met. E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59962 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations We requested comments on our proposals to implement the new requirements governing voluntary alignment under section 50331 of the Bipartisan Budget Act of 2018. We also sought comment on our proposal to create a limited exception to our proposed policies on voluntary alignment to allow a beneficiary to be assigned to an entity participating in a model tested or expanded under section 1115A of the Act when certain criteria are met. In addition, we welcomed comments on how we might increase beneficiary awareness and further improve the electronic process through which a beneficiary may voluntarily identify an ACO professional as their primary care provider through My.Medicare.gov for purposes of assignment to an ACO. Comment: Many commenters supported the proposed policies to implement the new requirements governing voluntary alignment under section 50331 of the Bipartisan Budget Act of 2018. In particular, many commenters supported the proposal to remove the requirement that a beneficiary must have received at least one primary care service from an ACO professional who is either a primary care physician or a physician with a specialty designation included in § 425.402(c) within the 12-month assignment window in order to be assigned to the ACO. Commenters were in favor of removing this requirement because it would allow a beneficiary to select a NP, PA, or CNS, who is participating in an ACO, as their primary clinician to voluntarily align to the ACO even if they do not receive care from any physicians participating in the ACO. Commenters suggested this more inclusive policy supports CMS’ goals of improving patient access and quality of care, and is consistent with patientcentered health care delivery. Additionally, some commenters specifically supported the proposal to allow a beneficiary to voluntarily designate any ACO professional, regardless of specialty, as their primary care provider for purposes of assignment to an ACO. In particular, commenters representing neurologists and palliative care practitioners were supportive of this proposed change. In addition, one commenter agreed that the proposed policy would allow ‘‘the opportunity for patients to choose and establish a medical home with their clinician.’’ The commenter also supported voluntary alignment because it results in prospective beneficiary attribution, which the commenter preferred over the preliminary VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 prospective assignment methodology with retrospective reconciliation. Response: We appreciate the commenters’ support for the proposed policies to implement the new requirements governing voluntary alignment under section 50331 of the Bipartisan Budget Act of 2018. Comment: A few commenters proposed a change to section 1899(h)(1)(A) of the Act. Section 1899(c) of the Act requires the Secretary to determine an appropriate method to assign Medicare FFS beneficiaries to an ACO based on their utilization of primary care services provided under this title by an ACO professional described in subsection (h)(1)(A). Section 1899(h)(1)(A) of the Act constitutes one element of the definition of the term ‘‘ACO professional’’. Specifically, this provision establishes that a physician (as defined in section 1861(r)(1)) is an ACO professional for purposes of the Shared Savings Program. Section 1861(r)(1) of the Act in turn defines the term physician as a doctor of medicine or osteopathy legally authorized to practice medicine and surgery by the State in which he performs such function or action. One commenter proposed a change to allow for ‘‘private NP led practices and NP led clinics’’ to be included as ACO professionals described in section 1899(h)(1)(A) of the Act. The commenter recommended this change in particular for rural areas, stating that NPs account for 1 in 4 medical providers in rural areas. Response: Because commenters are requesting a change to the statute, these suggestions are outside the scope of this final rule. However, as many commenters noted above, the proposed changes to the voluntary alignment methodology will allow a beneficiary to align with a NP, PA, or CNS participating in an ACO and ultimately be assigned to the ACO regardless of whether they receive care from a physician in the ACO. Additionally, we agree these non-physician practitioners play an important role in coordinating patient care and providing primary care services, as such we have included primary care services furnished by NPs, PAs, and CNSs in step 1 of our two-step claims-based assignment methodology (see § 425.402(b)). Comment: Some commenters opposed the proposed changes to the voluntary alignment methodology. One commenter expressed concern about beneficiary confusion if their practitioners participate in different ACOs or the beneficiary selects a practitioner outside of an ACO as their primary care provider. Similarly, one PO 00000 Frm 00128 Fmt 4701 Sfmt 4700 commenter expressed concern about an ACO’s ability to maintain an assigned population of 5,000 beneficiaries if beneficiaries can select any ACO professional regardless of specialty as their primary care provider. A few commenters disagreed with including all practitioner specialties citing differences in training, education, knowledge, and experience. Another commenter expressed concern about whether specialists are willing to take on the role of a primary care physician and manage the overall care of beneficiaries assigned to the ACO through voluntary alignment. Some commenters disagreed with the proposal to remove the requirement that a beneficiary receive a primary care service from an ACO professional, with a physician specialty used in assignment, during the assignment window. One commenter stated that removing the requirement would exacerbate a ‘‘leakage’’ problem that they described as a scenario where assigned beneficiaries receive some or all of their care from providers and suppliers outside the ACO. One commenter suggested beneficiaries should be required to renew their selection of their primary care clinician one year following the beneficiary’s entry into a long-term care setting. Another commenter suggested that beneficiaries who voluntarily align with an ACO be required to receive a minimum number of primary care services from ACO professionals within the same ACO in order to remain aligned to the ACO. Response: We disagree with these comments. We believe that when a beneficiary selects a primary clinician, they are identifying their primary care provider, regardless of specialty or whether the beneficiary has received a recent primary care service. We believe they are informing CMS that they view the practitioner as their primary care provider and responsible for managing their overall care. We also believe all practitioners, regardless of specialty, play an important role in coordinating care for beneficiaries and if a beneficiary selects a practitioner as their primary clinician, the beneficiary should be treated as having made an informed election. Although we understand the concern that an ACO could lose assigned beneficiaries due to their voluntary alignment with another ACO, we note that our experience to date shows that the majority of beneficiaries who voluntarily align to an ACO would have been assigned to the same ACO via our two-step claims-based assignment methodology under § 425.402(b). We E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations also believe requiring beneficiaries to renew their primary clinician selection would create additional unnecessary burden on beneficiaries. Beneficiaries who have designated a primary clinician must have established a MyMedicare.gov account, which likely indicates that they are actively engaged in reviewing and managing their health information. We believe these engaged beneficiaries will also manage and update their primary clinician selections as necessary. We also disagree with establishing a requirement that a beneficiary receive a minimum number of primary care services from ACO providers/suppliers in the ACO in order to honor a beneficiary’s voluntary alignment selection. We believe our proposed approach is in accordance with the requirement under section 1899(c) of the Act, as amended by section 50331 of the Bipartisan Budget Act of 2018, that primary care provider selections take precedence over any claims-based assignment. Comment: A few commenters suggested CMS simplify the process by which a beneficiary selects their primary clinician. Commenters suggested that, in addition to the electronic means of voluntary alignment, CMS allow beneficiaries to voluntarily align with their primary clinician through the ACO, at the point of care, through 1–800 Medicare, a smart phone application, or Physician Compare. One commenter noted they had experienced difficulties with CMS’ operationalization of the voluntary alignment policy through MyMedicare.gov. Response: Currently, if beneficiaries need help in designating a primary clinician, they can call 1–800 Medicare to have a representative walk them through the process or use the ‘‘Empowering Patients to Make Decisions About Their Healthcare: Register for MyMedicare.gov and Select Your Primary Clinician’’ fact sheet available at https://www.cms.gov/ Medicare/Medicare-Fee-for-ServicePayment/sharedsavingsprogram/ Downloads/vol-alignment-bene-factsheet.pdf. We plan to continue to make refinements to our implementation of voluntary alignment in order to improve the user experience for beneficiaries and will take the commenters’ suggestions into consideration in developing future policies regarding voluntary alignment. Comment: One commenter disagreed with allowing beneficiaries to voluntarily align with an ACO professional. The commenter cited difficulty tracking the cost of beneficiaries who are not assigned to an ACO through our two-step claims-based VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 assignment methodology. Another commenter suggested we not hold an ACO accountable for a voluntarily aligned beneficiary for a performance year if the beneficiary does not receive any services from their primary clinician in the ACO during that performance year. Another commenter opposed voluntary alignment because they believe the costs for voluntarily aligned beneficiaries are not reflected in an ACO’s historical benchmark. Response: Consistent with section 1899(c)(2)(B)(i) of the Act, we are required to allow beneficiaries to voluntarily identify an ACO professional as their primary care provider for purposes of assignment to an ACO if a system is available for electronic designation. To aid ACOs in identifying and tracking costs and Medicare services for voluntarily aligned beneficiaries, we provide ACOs with quarterly aggregate reports (see § 425.702) that identify beneficiaries who have voluntarily aligned with the ACO, as well as monthly claim and claim line feed files (see § 425.704) to aid ACOs in their operations. Additionally, as previously stated, we have found the majority of beneficiaries who voluntarily align to an ACO would have been assigned to the same ACO in the applicable performance year based on our two-step assignment methodology. As required under section 1899(b)(2)(A) of the Act and the regulation at § 425.100(a), ACOs participating in the Shared Savings Program must agree to become accountable for the quality, cost, and overall care of the Medicare fee-forservice beneficiaries assigned to the ACO. Beneficiaries who voluntarily align to an ACO are prospectively assigned to the ACO for the performance year. Under the prospective assignment methodology, ACOs are accountable for their assigned beneficiary population regardless of where the beneficiaries receive the plurality of their primary care services during the performance year. We believe this is an appropriate approach when a beneficiary selects a practitioner as their primary clinician. As we stated earlier, we believe that when a beneficiary selects a primary clinician, the beneficiary is making an informed decision and identifying for CMS the provider or supplier whom they consider to be responsible for managing their overall care. The historical benchmark reflects the beneficiary population who received the plurality of their primary care services from the ACO during the three benchmark years and, in our experience, there is a high correlation between the PO 00000 Frm 00129 Fmt 4701 Sfmt 4700 59963 beneficiaries who are assigned based on our two-step claims-based assignment methodology and voluntarily aligned beneficiaries. As a result, we believe our current benchmarking methodology provides for a population of assigned beneficiaries during the benchmark years that is comparable to the population assigned during the performance years. We also note, in the future, when an ACO renews for a new agreement period and its previous performance years become historical benchmark years, beneficiaries who were voluntarily aligned to the ACO for those years will then be included in the historical benchmark calculations for the ACO’s new agreement period. Comment: One commenter stated the current voluntary alignment process can be confusing and causes unnecessary delays in assigning beneficiaries to the ACO in which their primary clinician participates. The commenter suggested a rolling voluntary alignment process allowing beneficiaries who voluntarily align with an ACO to be added to the assignment list for that ACO during a performance year. Response: We understand that our policy of performing beneficiary assignment annually can cause a delay between when a beneficiary selects their primary clinician and when the beneficiary is assigned to the ACO. However, we believe this approach reduces complexity and burden. For example, ACOs are able to clearly identify a date by which to communicate to their beneficiaries regarding the opportunity to designate a primary clinician if they would like to align with an ACO professional. Comment: One commenter expressed concern that physicians with a specialty designation not used in assignment would become subject to the exclusivity requirements, which would limit an ACO participant to participation in a single ACO. The commenter opposed any policy that would require an ACO participant to be exclusive to a single Shared Savings Program ACO in the event that a beneficiary voluntarily aligns to a practitioner billing under the TIN of that ACO participant. Response: We agree with the concerns raised by the commenter and believe it is important to clarify the operational process we will implement if a beneficiary designates a clinician billing under the TIN of an ACO participant that participates in more than one Shared Savings Program ACO (as permitted under certain circumstances under § 425.306(b)) as their primary clinician. ACO participants that do not bill for services that are considered in assignment will not be required to be E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59964 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations exclusive to a single Shared Savings Program ACO as a result of the changes to the voluntary alignment methodology. In the circumstance where a beneficiary aligns with a clinician billing under an ACO participant TIN that is participating in more than one Shared Savings Program ACO, we will determine where the beneficiary received the plurality of their primary care services under our claims-based assignment methodology under § 425.402(b). If the beneficiary did not receive the plurality of their primary care services from ACO professionals in either ACO, we will not assign the beneficiary to either of the ACOs. However, consistent with § 425.402(c)(2)(iv), we will honor the beneficiary’s selection of a primary clinician and will not align the beneficiary to another ACO in which their primary clinician is not participating. We did not receive any public comments on the proposal not to voluntarily align a beneficiary to the ACO in which their primary clinician participates when the beneficiary is also eligible for assignment to an entity participating in a model tested or expanded under section 1115A of the Act under which claims-based assignment is based solely on claims for services other than primary care services (for example, CEC). After considering the comments received in response to the proposals to revise the voluntary alignment methodology, we are finalizing the policies as proposed. Specifically, we are finalizing the policy to assign a beneficiary to an ACO based upon their selection of any ACO professional, regardless of specialty, as their primary clinician. We are also finalizing our proposal to remove the requirement that a beneficiary must have received at least one primary care service from an ACO professional who is either a primary care physician or a physician with a specialty designation included in § 425.402(c) within the 12-month assignment window in order to be assigned to the ACO. Lastly, we are finalizing a policy not to voluntarily align a beneficiary to an ACO when the beneficiary is also eligible for assignment to an entity participating in a model tested or expanded under section 1115A of the Act under which claims-based assignment is based solely on claims for services other than primary care services. Accordingly, we are also finalizing the proposed revisions to § 425.402(e)(2) without modification. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 c. Revisions to the Definition of Primary Care Services Used in Beneficiary Assignment (1) Background Section 1899(c)(1) of the Act, as amended by the 21st Century Cures Act and the Bipartisan Budget Act of 2018, provides that for performance years beginning on or after January 1, 2019, the Secretary shall assign beneficiaries to an ACO based on their utilization of primary care services provided by a physician and all services furnished by RHCs and FQHCs. However, the statute does not specify which kinds of services may be considered primary care services for purposes of beneficiary assignment. We established the initial list of services that we considered to be primary care services in the November 2011 final rule (76 FR 67853). In that final rule, we indicated that we intended to monitor this issue and would consider making changes to the definition of primary care services to add or delete codes used to identify primary care services, if there were sufficient evidence that revisions were warranted. We have updated the list of primary care service codes in subsequent rulemaking to reflect additions or modifications to the codes that have been recognized for payment under the Medicare PFS, as summarized in the CY 2018 PFS proposed rule (82 FR 34109 and 34110). Subsequently, in the CY 2018 PFS final rule, we revised the definition of primary care services to include three additional chronic care management service codes, 99487, 99489, and G0506, and four behavioral health integration service codes, G0502, G0503, G0504 and G0507 (82 FR 53212 and 53213). These additions are effective for purposes of performing beneficiary assignment under § 425.402 for performance year 2019 and subsequent performance years. Accounting for these recent changes, we define primary care services in § 425.400(c) for purposes of assigning beneficiaries to ACOs under § 425.402 as the set of services identified by the following HCPCS/CPT codes: CPT codes: (1) 99201 through 99215 (codes for office or other outpatient visit for the evaluation and management of a patient). (2) 99304 through 99318 (codes for professional services furnished in a Nursing Facility, excluding services furnished in a SNF which are reported on claims with place of service code 31). (3) 99319 through 99340 (codes for patient domiciliary, rest home, or custodial care visit). PO 00000 Frm 00130 Fmt 4701 Sfmt 4700 (4) 99341 through 99350 (codes for evaluation and management services furnished in a patients’ home). (5) 99487, 99489 and 99490 (codes for chronic care management). (6) 99495 and 99496 (codes for transitional care management services). HCPCS codes: (1) G0402 (the code for the Welcome to Medicare visit). (2) G0438 and G0439 (codes for the Annual Wellness Visits). (3) G0463 (code for services furnished in electing teaching amendment hospitals). (4) G0506 (code for chronic care management). (5) G0502, G0503, G0504 and G0507 (codes for behavioral health integration). As discussed in the CY 2018 PFS final rule (82 FR 53213), a commenter recommended that CMS consider including the advance care planning codes, CPT codes 99497 and 99498, in the definition of primary care services in future rulemaking. We indicated that we would consider whether CPT codes 99497 and 99498 or any additional existing HCPCS/CPT codes should be added to the definition of primary care services in future rulemaking for purposes of assignment of beneficiaries to ACOs under the Shared Savings Program. In addition, effective for CY 2018, the HCPCS codes for behavioral health integration G0502, G0503, G0504 and G0507 have been replaced by CPT codes 99492, 99493, 99494, 99484 (82 FR 53078). CPT codes 99304 through 99318 are used for reporting evaluation and management (E&M) services furnished by physicians and other practitioners in a SNF (reported on claims with POS code 31) or a nursing facility (reported on claims with POS code 32). Based on stakeholder input, we finalized a policy in the CY 2016 PFS final rule (80 FR 71271 through 71272) effective for performance year 2017 and subsequent performance years, to exclude services identified by CPT codes 99304 through 99318 from the definition of primary care services for purposes of the beneficiary assignment methodology when the claim includes the POS code 31 modifier designating the services as having been furnished in a SNF. We established this policy to recognize that SNF patients are shorter stay patients who are generally receiving continued acute medical care and rehabilitative services. Although their care may be coordinated during their time in the SNF, they are then transitioned back into the community to the primary care professionals who are typically responsible for providing care to meet their true primary care needs. We E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations amozie on DSK3GDR082PROD with RULES3 continue to believe that it is appropriate for SNF patients to be assigned to ACOs based on care received from primary care professionals in the community (including nursing facilities), who are typically responsible for providing care to meet the true primary care needs of these beneficiaries. As we discussed in the August 2019 proposed rule (83 FR 41897), ACOs serving special needs populations, including beneficiaries receiving long term care services, and other stakeholders have recently suggested that we consider an alternative method for determining operationally whether services identified by CPT codes 99304 through 99318 were furnished in a SNF. Instead of indirectly determining whether a beneficiary was a SNF patient when the services were furnished based on physician claims data, these stakeholders suggest we more directly determine whether a beneficiary was a SNF patient based on SNF facility claims data. These commenters recommended that CMS use contemporaneous SNF Medicare facility claims to determine whether a professional service identified by CPT codes 99304 through 99318 was furnished in a SNF, and therefore, should not be used for purposes of the beneficiary assignment methodology under § 425.402. Specifically, these commenters suggested that we determine whether services identified by CPT codes 99304 through 99318 were furnished in a SNF by determining whether the beneficiary also received SNF facility services on the same date of service. In the August 2018 proposed rule (83 FR 41897 through 41899), we proposed to make changes to the definition of primary care services in § 425.400(c) to add new codes and to revise how we determine whether services identified by CPT codes 99304 through 99318 were furnished in a SNF. (2) Proposed Revisions Based on feedback from ACOs and our further review of the HCPCS and CPT codes currently recognized for payment under the PFS, we believe it would be appropriate to amend the definition of primary care services to include certain additional codes. Specifically, we proposed to revise the definition of primary care services in § 425.400(c) to include the following HCPCS and CPT codes: (1) Advance care planning service codes; CPT codes 99497 and 99498; (2) administration of health risk assessment service codes; CPT codes 96160 and 96161; (3) prolonged evaluation and management or psychotherapy service(s) beyond the VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 typical service time of the primary procedure, CPT codes 99354 and 99355; (4) annual depression screening service code, HCPCS code G0444; (5) alcohol misuse screening service code, HCPCS code G0442; and (6) alcohol misuse counseling service code, HCPCS code G0443. In addition, in the CY 2019 PFS proposed rule (see 83 FR 35841 through 35844), CMS proposed to create three new HCPCS codes to reflect the additional resources involved in furnishing certain evaluation and management services: (1) GPC1X add-on code, for the visit complexity inherent to evaluation and management associated with certain primary care services, (2) GCG0X add-on code, for visit complexity inherent to evaluation and management associated with endocrinology, rheumatology, hematology/oncology, urology, neurology, obstetrics/gynecology, allergy/immunology, otolaryngology, or interventional pain managementcentered care, and (3) GPRO1, an additional add-on code for prolonged evaluation and management or psychotherapy services beyond the typical service time of the primary procedure. As we explained in the August 2018 proposed rule (83 FR 41897), we believe it would be appropriate to include these codes in the definition of primary care services under the Shared Savings Program because these codes are used to bill for services that are similar to services that are already included in the list of primary care codes at § 425.400(c). We also expect that primary care physicians, nurse practitioners, physician assistants, and clinical nurse specialists frequently furnish these services as part of their overall management of a patient. As a result, we believe that including these codes would increase the accuracy of the assignment process by helping to ensure that beneficiaries are assigned to the ACO or other entity that is actually managing the beneficiary’s care. The following provides additional information about the HCPCS and CPT codes that we proposed to add to the definition of primary care services: • Advance care planning (CPT codes 99497 and 99498): Effective January 1, 2016, CMS pays for voluntary advance care planning under the PFS (80 FR 70955 through 70959). See CMS, Medicare Learning Network, ‘‘Advance Care Planning’’ (ICN 909289, August 2016), available at https://www.cms.gov/ Outreach-and-Education/MedicareLearning-Network-MLN/MLNProducts/ Downloads/AdvanceCarePlanning.pdf. Advance care planning enables Medicare beneficiaries to make PO 00000 Frm 00131 Fmt 4701 Sfmt 4700 59965 important decisions that give them control over the type of care they receive and when they receive it. Medicare pays for advance care planning either as a separate Part B service when it is medically necessary or as an optional element of a beneficiary’s Annual Wellness Visit. We believe it would be appropriate to include both Advance Care Planning codes 99497 and 99498 in the definition of primary care services under the Shared Savings Program because the services provided as part of advance care planning include counseling and other evaluation and management services similar to the services included in Annual Wellness Visits and other evaluation and management service codes that are already included in the list of primary care codes. • Administration of health risk assessment (CPT codes 96160 and 96161): In the CY 2017 PFS final rule (81 FR 80330 through 80331), we added two new CPT codes, 96160 and 96161, to the PFS, effective for CY 2017, to be used for payment for the administration of health risk assessment. These codes are ‘‘add-on codes’’ that describe additional resource components of a broader service furnished to the patient that are not accounted for in the valuation of the base code. For example, if a health risk assessment service were administered during a physician office visit, then the physician would bill for both the appropriate office visit code and the appropriate health risk assessment code. We believe it would be appropriate to include CPT codes 96160 and 96161 in the definition of primary care services because these add-on codes frequently represent additional practice expenses related to office visits for evaluation and management services that are already included in the definition of primary care services. • Prolonged evaluation and management or psychotherapy service(s) beyond the typical service time of the primary procedure (CPT codes 99354 and 99355): These two codes are also ‘‘add-on codes’’ that describe additional resource components of a broader service furnished in the office or other outpatient setting that are not accounted for in the valuation of the base codes. Code 99354 is listed on a claim to report the first hour of additional face-to-face time with a patient and code 99355 is listed separately for each additional 30 minutes of face-to-face time with a patient beyond the time reported under code 99354. Codes 99354 and 99355 would be billed separately in addition to the base office or other outpatient evaluation and management or E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59966 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations psychotherapy service. (See Medicare Claims Processing Manual Chapter 12, Sections 30.6.15.1 Prolonged Services With Direct Face-to-Face Patient Contact Service (Codes 99354–99357) available at https://www.cms.gov/Regulationsand-Guidance/Guidance/Manuals/ downloads/clm104c12.pdf; also see CMS, MLN Matters, Prolonged Services (Codes 99354–99359) (Article Number MM5972, Revised March 7, 2017), available at https://www.cms.gov/ Outreach-and-Education/MedicareLearning-Network-MLN/ MLNMattersArticles/downloads/ mm5972.pdf.) Although we do not currently include prolonged services codes CPT codes 99354 and 99355 on our list of primary care services, based on further review we believe it would be appropriate to include them on our list of primary care services to more accurately assign beneficiaries to ACOs based on all the allowed charges for the primary care services furnished to beneficiaries. In the August 2018 proposed rule (83 FR 41898), we noted that the definitions of codes 99354 and 99355 also include prolonged services for certain psychotherapy services, which are not currently included on our list of primary care services. Therefore, we proposed to include the allowed charges for CPT codes 99354 and 99355, for purposes of assigning beneficiaries to ACOs, only when the base code is also on the list of primary care services. • Annual depression screening (HCPCS code G0444), alcohol misuse screening (HCPCS code G0442), and alcohol misuse counseling (HCPCS code G0443): Effective October 14, 2011, all Medicare beneficiaries are eligible for annual depression screening and alcohol misuse screening. (See CMS Manual System, Screening for Depression in Adults (Transmittal 2359, November 23, 2011) available at https:// www.cms.gov/Regulations-andGuidance/Guidance/Transmittals/ downloads/R2359CP.pdf; and see CMS, MLN Matters, Screening and Behavioral Counseling Interventions in Primary Care to Reduce Alcohol Misuse (Article Number MM7633, Revised June 4, 2012), available at https://www.cms.gov/ Outreach-and-Education/MedicareLearning-Network-MLN/ MLNMattersArticles/downloads/ mm7633.pdf). Although these three codes have been in use since before the implementation of the Shared Savings Program in 2012, based on further review of these services, we believe that it would be appropriate to consider these services in beneficiary assignment. Annual depression screening may be covered if it is furnished in a primary VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 care setting that has staff-assisted depression care supports in place to assure accurate diagnosis, effective treatment, and follow-up. Alcohol misuse screening and counseling are screening and behavioral counseling interventions in primary care to reduce alcohol misuse. All three of these codes include screening and counseling services similar to counseling and other evaluation and management services included in the codes already on the list of primary care codes. In the CY 2019 PFS proposed rule (see 83 FR 35841 through 35844), we proposed to create three new HCPCS G-codes as part of a broader proposal to simplify the documentation requirements and to more accurately pay for services represented by CPT codes 99201 through 99215 (codes for office or other outpatient visit for the evaluation and management of a patient). All three of these codes are ‘‘add-on codes’’ that describe additional resource components of a broader service furnished to the patient that are not accounted for in the valuation of the base codes. HCPCS code GPC1X is intended to capture the additional resource costs, beyond those involved in the base evaluation and management codes, of providing face-to-face primary care services for established patients. HCPCS code GPC1X would be billed in addition to the base evaluation and management code for an established patient when the visit includes primary care services. In contrast, new HCPCS code GCG0X is an add-on code intended to reflect the complexity inherent to evaluation and management services associated with endocrinology, rheumatology, hematology/oncology, urology, neurology, obstetrics/gynecology, allergy/immunology, otolaryngology, cardiology, and interventional pain management-centered care. As we stated in the August 2018 proposed rule (83 FR 41899), we believe it would be appropriate to include both proposed new HCPCS codes GCG0X and GPC1X in our definition of primary care services because they represent services that are currently included in CPT codes 99201 through 99215, which are already included in the list of primary care codes in § 425.400(c). Finally, proposed new HCPCS code GPRO1 (prolonged evaluation and management or psychotherapy services beyond the typical service time of the primary procedure, in the office or other outpatient setting requiring direct patient contact beyond the usual service; 30 minutes) is modeled on CPT code 99354, a prolonged services code discussed earlier in this section which PO 00000 Frm 00132 Fmt 4701 Sfmt 4700 we proposed to add to our list of primary care services. HCPCS code GPRO1 is intended to reflect prolonged evaluation and management or psychotherapy service(s) of 30 minutes duration beyond the typical service time of the primary or base service, whereas existing CPT code 99354 reflects prolonged services of 60 minutes duration. As is the case for code 99354, code GPRO1 would be billed separately in addition to the base office or other outpatient evaluation and management or psychotherapy service. We stated that we believe it would be appropriate to include proposed HCPCS code GPRO1 on our list of primary care services for the same reasons we proposed to add CPT code 99354 to our list of primary care services. Because the proposed definition of HCPCS code GPRO1 also includes prolonged services for certain psychotherapy services, which are not currently included on our list of primary care services, we proposed to include the allowed charges for HCPCS code GPRO1, for purposes of assigning beneficiaries to ACOs, only when the base code is also on the list of primary care services. We proposed to include these codes in the definition of primary care services when performing beneficiary assignment under § 425.402, for performance years starting on January 1, 2019, and subsequent years. However, we noted that our proposal to include the three proposed new ‘‘add-on codes’’, GPC1X, GCG0X, and GPRO1, was contingent on CMS finalizing its proposal to create these new codes for use starting in 2019. As discussed in section V.B.2.c.(1) of this final rule, ACOs and other commenters have expressed concerns regarding our current policy of identifying services billed under CPT codes 99304 through 99318 furnished in a SNF by using the POS modifier 31. We continue to believe it is appropriate to exclude from assignment services billed under CPT codes 99304 through 99318 when such services are furnished in a SNF. However, as we explained in the August 2018 proposed rule (83 FR 41899), we agree with commenters that it might increase the accuracy of beneficiary assignment for these vulnerable and generally high cost beneficiaries if we were to revise our method for determining whether services identified by CPT codes 99304 through 99318 were furnished in a SNF to focus on whether the beneficiary also received SNF facility services on the same day. We believe it would be feasible for us to directly and more precisely determine whether services identified by CPT codes 99304 through E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 99318 were furnished in a SNF by analyzing our facility claims data files rather than by using the POS modifier 31 in our professional claims data files. Operationally, we would exclude professional services claims billed under CPT codes 99304 through 99318 from use in the assignment methodology when there is a SNF facility claim in our claims files with dates of service that overlap with the date of service for the professional service. Therefore, we proposed to revise the regulation at § 425.400(c)(1)(iv)(A)(2), effective for performance years starting on January 1, 2019 and subsequent performance years, to remove the exclusion of claims including the POS code 31 and in its place to indicate more generally that we will exclude services billed under CPT codes 99304 through 99318 when such services are furnished in a SNF. Under our current process, if CMS’ HCPCS committee or the American Medical Association’s CPT Editorial Panel modifies or replaces any of the codes that we designate as primary care service codes in § 425.400(c), we must revise the primary care service codes listed in § 425.400(c) as appropriate through further rulemaking before the revised codes can be used for purposes of assignment. As noted previously, effective for CY 2018, the HCPCS codes for behavioral health integration G0502, G0503, G0504 and G0507 have been replaced by CPT codes 99492, 99493, 99494 and 99484. Therefore, consistent with our current process, we proposed to revise the primary care service codes in § 425.400(c)(1)(iv) to replace HCPCS codes G0502, G0503, G0504 and G0507 with CPT codes 99492, 99493, 99494 and 99484 for performance years starting on January 1, 2019, and subsequent performance years. We also noted that the regulations text at § 425.400(c)(1)(iv) includes brief descriptions for the HCPCS codes that we have designated as primary care service codes, but does not include such descriptions for the CPT codes that we have designated as primary care service codes. For consistency, we proposed a technical change to the regulations at § 425.400(c)(1)(iv)(A) to also include descriptions for the CPT codes. We also noted that one of the Chronic Care Management (CCM) codes, CPT code 99490, is inadvertently listed in the regulations text at § 425.400(c)(1)(iv)(A)(6) along with the codes for Transitional Care Management (TCM) services. We proposed a technical change to the regulations to move CPT code 99490 up to § 425.400(c)(1)(iv)(A)(5) with the other CCM codes. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 We welcomed comments on the new codes we proposed to add to the definition of primary care services used for purposes of assigning beneficiaries to Shared Savings Program ACOs. In addition, we sought comment on our proposal to revise our method for excluding services identified by CPT codes 99304 through 99318 when furnished in a SNF. We also sought comment on the other proposed technical changes to § 425.400(c)(1)(iv). We also welcomed comments on any additional existing HCPCS/CPT codes that we should consider adding to the definition of primary care services in future rulemaking. Comment: Some commenters supported the proposed changes to the definition of primary care services. One commenter suggested we include the Initial Preventive Physician Examination, or Welcome to Medicare Visit, as well as the annual wellness visit CPT codes in the definition. Response: We appreciate the commenters’ support for the proposed amendments to the definition of primary care services. We also note we currently include the Welcome to Medicare (G0402) and annual wellness visit (G0438 and G0439) CPT codes in the definition of primary care services under § 425.400(c). Comment: Many commenters supported the proposal to modify § 425.400(c)(1)(iv)(A)(2) to remove the exclusion of claims including the POS code 31 and in its place indicate more generally that we will exclude services billed under CPT codes 99304 through 99318 from use in the assignment methodology when such services are furnished in a SNF, as determined based on whether there is a SNF facility claim with dates of service that overlap with the date of service for the professional service. One commenter supported this proposal because they noted it would better identify beneficiaries who have received short-term care and appropriately exclude them from assignment. Response: We appreciate the commenters’ support for the proposal to modify § 425.400(c)(1)(iv)(A)(2) to remove the exclusion of claims including the POS code 31 modifier and in its place to exclude services billed under CPT codes 99304 through 99318 when such services are furnished in a SNF. We are finalizing the policy as proposed. Comment: Concerning the proposal to remove the exclusion of claims including the POS code 31, one commenter suggested we use a longer claims run-out period to account for the institutional billing practices for SNFs. PO 00000 Frm 00133 Fmt 4701 Sfmt 4700 59967 This commenter also stated they would ‘‘welcome transparency related to POS 31 and 32 claims-based attribution’’ in the claim and claims line feed files we provide to participating ACOs under § 425.704. Response: As we noted in the 2011 Shared Savings Program final rule (76 FR 67837), a 3-month claims run-out results in a completion percentage of approximately 98.5 percent for physician services and 98 percent for Part A services. Additionally, the claim and claim line feed files furnished to ACOs under § 425.704 contain Parts A and B claims data regarding beneficiaries who are either prospectively assigned to the ACO or who may be assigned to the ACO at the end of the performance year, depending on the assignment methodology under which the ACO participates. As long as the beneficiary has not declined to share their claims data, and the claim does not include protected health information related to substance use disorder treatment, ACOs receive both the claims for physician services and the facility level claims that would be used to determine whether a service billed under CPT codes 99304 through 99318 was furnished in a SNF. Comment: A few commenters suggested we only include the newly proposed CPT/HCPCS codes under step 1 of the two-step assignment methodology. The commenters stated these codes should be used for ‘‘assigning beneficiaries on the basis of care furnished specifically by primary care physicians and not all ACO professionals.’’ Response: We disagree with these comments. We continue to believe our current assignment methodology generally provides an appropriate balance between maintaining a strong emphasis on primary care while ultimately allowing for assignment of beneficiaries on the basis of how they actually receive their primary care services (80 FR 32748). We also note that the list of specialty types included in step 1 and step 2 of the assignment methodology was informed by CMS medical officers knowledgeable about the services typically performed by physicians and non-physician practitioners (80 FR 32750) as well as comments received in response to the 2014 Shared Savings Program proposed rule. Comment: One commenter suggested an alternative assignment methodology that the commenter believed would be similar to a methodology discussed in the CY 2019 PFS proposed rule which would distinguish between primary and secondary specialties for practitioners E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59968 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations billing under the same TIN as part of a multispecialty group. The commenter stated this approach would improve the accuracy of the assignment methodology by focusing on evaluation and management services furnished by primary care providers, rather than specialists. Alternatively, this commenter suggested an assignment methodology similar to methodologies used by state agencies. According to the commenter, this assignment methodology would allow for exclusions, attribution, and tie-breaking steps to support a valid beneficiary population. Response: We encourage the commenter to review our assignment methodology under the Shared Savings Program regulations at 42 CFR part 425, subpart E. Our current assignment methodology emphasizes primary care services provided by primary care clinicians in step one, before considering primary care services furnished by certain specialists in step two. However, we will continue to monitor this issue to determine whether there have been any changes or refinements that would allow us to more precisely identify both primary and secondary practitioner specialties in Medicare claims data and whether those changes should be accounted for in the assignment methodology used in the Shared Savings Program. Any changes to our assignment methodology would be proposed through future rulemaking for the Shared Savings Program. As discussed earlier in this final rule, the proposal to create three new HCPCS G-codes as part of a broader proposal to simplify the documentation requirements and to more accurately pay for the office or other outpatient evaluation and management services represented by CPT codes 99201 through 99215 is not being finalized. Therefore, the proposal to include HCPCS ‘‘add-on codes’’, GPC1X, GCG0X, and GPRO1 in the definition of ‘‘primary care services’’ will not be finalized at this time. We will revisit this proposal in future rulemaking and continue to monitor the annual rulemaking for the PFS to determine if we should propose any changes to the definition of primary care services for the Shared Savings Program to reflect proposed HCPCS/CPT coding changes. We received no comments on the proposed technical changes to § 425.400(c)(1)(iv). After considering the comments received, we are finalizing our proposed revisions to the definition of primary care services, with the exception of the proposal to include the three add-on HCPCS codes GPC1X, GCG0X, and GPRO1. Specifically, we VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 are revising the definition of primary care services in § 425.400(c) to add CPT codes 99497, 99498, 96160, 96161, 99354, and 99355, and HCPCS codes G0444, G0442, and G0443. Additionally, we are finalizing, as proposed, the revisions to our method for excluding services identified by CPT codes 99304 through 99318 when furnished in a SNF and the proposed technical changes to § 425.400(c)(1)(iv). Consistent with the approach we have taken in the past when implementing changes to the assignment methodology, we will adjust ACOs’ historical benchmarks for the performance year starting on January 1, 2019, to account for the changes to the assignment methodology that we are finalizing in this final rule. d. Extreme and Uncontrollable Circumstances Policies for the Shared Savings Program (1) Background Following the 2017 California wildfires and Hurricanes Harvey, Irma, Maria, and Nate, stakeholders expressed concerns that the effects of these types of disasters on ACO participants, ACO providers/suppliers, and the assigned beneficiary population could undermine an ACO’s ability to successfully meet the quality performance standards, and adversely affect financial performance, including, in the case of ACOs under performance-based risk, increasing shared losses. To address these concerns, we published an interim final rule with comment period titled Medicare Program; Medicare Shared Savings Program: Extreme and Uncontrollable Circumstances Policies for Performance Year 2017 (hereinafter referred to as the Shared Savings Program IFC) that appeared in the December 26, 2017 Federal Register (82 FR 60912). In the Shared Savings Program IFC, we established policies for addressing ACO quality performance scoring and the determination of the shared losses owed by ACOs participating under performance-based risk tracks for ACOs that were affected by extreme or uncontrollable circumstances during performance year 2017. The policies adopted in the Shared Savings Program IFC were effective for performance year 2017, including the applicable quality data reporting period for the performance year. We have considered the comments received on the Shared Savings Program IFC in developing the policies for 2018 and subsequent years. The extreme and uncontrollable circumstances policies established in the Shared Savings Program for PO 00000 Frm 00134 Fmt 4701 Sfmt 4700 performance year 2017 align with the policies established under the Quality Payment Program for the 2017 MIPS performance period and subsequent MIPS performance periods (see CY 2018 Quality Payment Program final rule with comment, 82 FR 53780 through 53783 and Quality Payment Program IFC, 82 FR 53895 through 53900). In particular, in the Shared Savings Program IFC (82 FR 60914), we indicated that we would determine whether an ACO had been affected by an extreme and uncontrollable circumstance by determining whether 20 percent or more of the ACO’s assigned beneficiaries resided in counties designated as an emergency declared area in performance year 2017 as determined under the Quality Payment Program or the ACO’s legal entity was located in such an area. In the Quality Payment Program IFC (82 FR 53897), we explained that we anticipated that the types of events that could trigger the extreme and uncontrollable circumstances policies would be events designated a Federal Emergency Management Agency (FEMA) major disaster or a public health emergency declared by the Secretary, although we indicated that we would review each situation on a case-by-case basis. Because ACOs may face extreme and uncontrollable circumstances in 2018 and subsequent years, we proposed to extend the policies adopted in the Shared Savings Program IFC for addressing ACO quality performance scoring and the determination of the shared losses owed for ACOs affected by extreme or uncontrollable circumstances to performance year 2018 and subsequent performance years. In addition, in the Shared Savings Program IFC, we indicated that we planned to observe the impact of the 2017 hurricanes and wildfires on ACOs’ expenditures for their assigned beneficiaries during performance year 2017, and might revisit the need to make adjustments to the methodology for calculating the benchmark in future rulemaking. We considered this issue further in the August 2018 proposed rule (see 83 FR 41904 through 41906). (2) Proposed Revisions The financial and quality performance of ACOs located in areas subject to extreme and uncontrollable circumstances could be significantly and adversely affected. Disasters may have several possible effects on ACO quality and financial performance. For instance, displacement of beneficiaries may make it difficult for ACOs to access medical record data required for quality E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations reporting, as well as, reduce the beneficiary response rate on survey measures. Further, for practices damaged by a disaster, the medical records needed for quality reporting may be inaccessible. We also believe that disasters may affect the infrastructure of ACO participants, ACO providers/suppliers, and potentially the ACO legal entity itself, thereby disrupting routine operations related to their participation in the Shared Savings Program and achievement of program goals. The effects of a disaster could include challenges in communication between the ACO and its participating providers and suppliers and in implementation of and participation in programmatic activities. Catastrophic events outside the ACO’s control can also increase the difficulty of coordinating care for patient populations, and due to the unpredictability of changes in utilization and cost of services furnished to beneficiaries, may have a significant impact on expenditures for the applicable performance year and the ACO’s benchmark in the subsequent agreement period. These factors could jeopardize ACOs’ ability to succeed in the Shared Savings Program, and ACOs, especially those in performance-based risk tracks, may reconsider whether they are able to continue their participation in the program. As we stated in the August 2018 proposed rule (83 FR 41900), because widespread disruptions could occur during 2018 or subsequent performance years, we believe it is appropriate to have policies in place to change the way in which we assess the quality and financial performance of Shared Savings Program ACOs in any affected areas. Accordingly, we proposed to extend the automatic extreme and uncontrollable circumstances policies under the Shared Savings Program that were established for performance year 2017 to performance year 2018 and subsequent performance years. Specifically, we proposed that the Shared Savings Program extreme and uncontrollable circumstances policies for performance year 2018 and subsequent performance years would apply when we determine that an event qualifies as an automatic triggering event under the Quality Payment Program. As we discussed in the Shared Savings Program IFC (82 FR 60914), we believe it is also appropriate to extend these policies to encompass the quality reporting period, unless the reporting period is extended, because if an ACO is unable to submit its quality data as a result of a disaster occurring during the quality data submission VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 window, we would not have the quality data necessary to measure the ACO’s quality performance for the performance year. For example, if an extreme and uncontrollable event were to occur in February 2019, which we anticipate would be during the quality data reporting period for performance year 2018, then the extreme and uncontrollable circumstances policies would apply for quality data reporting and quality performance scoring for performance year 2018, if the reporting period is not extended. We explained that we do not believe it is appropriate to extend this policy to encompass the quality data reporting period if the reporting period is extended because affected ACOs would have an additional opportunity to submit their quality data, enabling us to measure their quality performance in the applicable performance year. Accordingly, we also proposed that the policies regarding quality reporting would apply with respect to the determination of the ACO’s quality performance in the event that an extreme and uncontrollable event occurs during the applicable quality data reporting period for a performance year and the reporting period is not extended. However, we noted that, because a disaster that occurs after the end of the performance year would have no impact on the determination of an ACO’s financial performance for that performance year, it would not be appropriate to make an adjustment to shared losses in the event an extreme or uncontrollable event occurs during the quality data reporting period. Comment: Commenters overwhelmingly supported adopting permanent policies to mitigate the impacts of extreme and uncontrollable circumstances. Several commenters supported finalizing the proposals without modification; however, the majority of commenters suggested modifications to the proposed policies or requested that CMS adopt additional means of providing relief to disaster affected ACOs. The comments and recommendations are discussed below in sections V.B.2.d.(1), (2), and (3) of this final rule. Response: We appreciate commenters’ support for adopting permanent policies to provide relief to ACOs that are affected by extreme and uncontrollable circumstances. Comment: A few commenters recommended that CMS take into consideration whether an ACO has experienced an extreme and uncontrollable event during its agreement period when applying certain policies proposed in other sections of PO 00000 Frm 00135 Fmt 4701 Sfmt 4700 59969 the August 2018 proposed rule, if finalized. These included proposed policies related to monitoring for financial performance, repayment mechanism amounts, reconciliation after termination and the determination of participant Medicare FFS revenue and prior participation for purposes of determining participation options. Response: We thank commenters for their suggestions on ways to further limit the potential negative impacts of extreme and uncontrollable circumstances on ACOs affected by such events. We believe that these suggestions fall outside the scope of the proposals described in section II.E.4 of the August 2018 proposed rule that we are addressing in this final rule. We anticipate discussing our proposals related to other sections of the August 2018 proposed rule in a forthcoming final rule and will address comments related to those sections at that time. (a) Modification of Quality Performance Scores for All ACOs in Affected Areas As we explained in the Shared Savings Program IFC (82 FR 60914 through 60916), ACOs and their ACO participants and ACO providers/ suppliers are frequently located across several different geographic regions or localities, serving a mix of beneficiaries who may be differentially impacted by hurricanes, wildfires, or other triggering events. Therefore, for 2017, we established a policy for determining when an ACO, which may have ACO participants and ACO providers/ suppliers located in multiple geographic areas, would qualify for the automatic extreme and uncontrollable circumstance policies for the determination of quality performance. Specifically, we adopted a policy for performance year 2017 of determining whether an ACO had been affected by extreme and uncontrollable circumstances by determining whether 20 percent or more of the ACO’s assigned beneficiaries resided in counties designated as an emergency declared area in the performance year, as determined under the Quality Payment Program as discussed in the Quality Payment Program IFC (82 FR 53898) or the ACO’s legal entity was located in such an area. For 2017, we adopted a policy under which the location of an ACO’s legal entity was determined based on the address on file for the ACO in CMS’ ACO application and management system. We used 20 percent of the ACO’s assigned beneficiary population as the minimum threshold to establish an ACO’s eligibility for the policies regarding quality reporting and quality E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59970 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations performance scoring for 2017 because, as we stated in the Shared Savings Program IFC, we believe the 20 percent threshold provides a reasonable way to identify ACOs whose quality performance may have been adversely affected by an extreme or uncontrollable circumstance, while excluding ACOs whose performance would not likely be significantly affected. The 20 percent threshold was selected to account for the effect of an extreme or uncontrollable circumstance on an ACO that has the minimum number of assigned beneficiaries to be eligible for the program (5,000 beneficiaries), and in consideration of the average total number of unique beneficiaries for whom quality information is required to be reported in the combined CAHPS survey sample (860 beneficiaries) and the CMS Web Interface sample (approximately 3,500 beneficiaries). (There may be some overlap between the CAHPS sample and the CMS Web Interface sample.) Therefore, we estimated that an ACO with an assigned population of 5,000 beneficiaries typically would be required to report quality information on a total of 4,000 beneficiaries. Thus, we indicated that we believe the 20 percent threshold ensures that an ACO with the minimum number of assigned beneficiaries would have an adequate number of beneficiaries across the CAHPS and CMS Web Interface samples in order to fully report on these measures. However, we also noted that it is possible that some ACOs that have fewer than 20 percent of their assigned beneficiaries residing in affected areas may have a legal entity that is located in an emergency declared area. Consequently, their ability to quality report may be equally impacted because the ACO legal entity may be unable to collect the necessary information from their ACO participants or may experience infrastructure issues related to capturing, organizing, and reporting the data to CMS. We stated that if less than 20 percent of the ACO’s assigned beneficiaries reside in an affected area and the ACO’s legal entity is not located in a county designated as an affected area, then we believe that there is unlikely to be a significant impact upon the ACO’s ability to report or on the representativeness of the quality performance score that is determined for the ACO. For performance year 2017, we determined what percentage of the ACO’s performance year assigned population was affected by a disaster based on the final list of beneficiaries assigned to the ACO for the performance year. Although beneficiaries are VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 assigned to ACOs under Track 1 and Track 2 based on preliminary prospective assignment with retrospective reconciliation after the end of the performance year, these ACOs were able to use their quarterly assignment lists, which include beneficiaries’ counties of residence, for early insight into whether they were likely to meet the 20 percent threshold. In the Shared Savings Program IFC, we modified the quality performance standard specified under § 425.502 by adding a new paragraph (f) to address potential adjustments to the quality performance scores for performance year 2017 of ACOs determined to be affected by extreme and uncontrollable circumstances. We also modified § 425.502(e)(4) to specify that an ACO receiving the mean Shared Savings Program ACO quality score for performance year 2017 based on the extreme and uncontrollable circumstances policies would not be eligible for bonus points awarded based on quality improvement in that year because quality data would not be available to determine if there was improvement from year to year. In the Shared Savings Program IFC, we established policies with respect to quality reporting and quality performance scoring for the 2017 performance year. In anticipation of any future extreme and uncontrollable events, in the August 2018 proposed rule (83 FR 41901) we proposed to extend these policies, with minor modifications, to subsequent performance years as well. In order to avoid confusion and reduce unnecessary burdens on affected ACOs, we proposed to align our policies for 2018 and subsequent years with policies established for the Quality Payment Program in the final rule with comment period, entitled CY 2018 Updates to the Quality Payment Program (82 FR 53568). Specifically, we proposed to apply determinations made under the Quality Payment Program with respect to whether an extreme and uncontrollable circumstance has occurred and the identification of the affected geographic areas and the applicable time periods. Generally, in line with the approach taken for 2017 in the Quality Payment Program IFC (82 FR 53897), we anticipated that the types of events that would be considered an automatic triggering event would be events designated as a Federal Emergency Management Agency (FEMA) major disaster or a public health emergency declared by the Secretary, but indicated that CMS would review each situation on a caseby-case basis. We also proposed that PO 00000 Frm 00136 Fmt 4701 Sfmt 4700 CMS would have sole discretion to determine the time period during which an extreme and uncontrollable circumstance occurred, the percentage of the ACO’s assigned beneficiaries residing in the affected areas, and the location of the ACO legal entity. Additionally, we proposed to determine an ACO’s legal entity location based on the address on file for the ACO in CMS’ ACO application and management system. In the Shared Savings Program IFC, we established a policy for performance year 2017 under which we determined the percentage of the ACO’s assigned population that was affected by a disaster based on the final list of beneficiaries assigned to the ACO for the performance year. We begin producing the final list of assigned beneficiaries after allowing for 3 months of claims run out following the end of a performance year. However, the quality reporting period ends before the 3-month claims run out period ends. Therefore, in the August 2018 proposed rule we expressed concern that if, for future performance years, we continue to calculate the percentage of affected beneficiaries based on the ACO’s final list of assigned beneficiaries, it would not be operationally feasible for us to notify an ACO as to whether it meets the 20 percent threshold prior to the end of the quality reporting period because the final list of assigned beneficiaries is not available until after the close of the quality reporting period. We explained that we now believe it would be appropriate to base this calculation on the list of assigned beneficiaries used to generate the Web Interface quality reporting sample, which would be available with the quarter three program reports, generally in November of the applicable performance year. We also indicated this report would be available to ACOs participating in the proposed 6month performance year from January 1, 2019 through June 30, 2019. By basing the calculation on the list of assigned beneficiaries used to generate the Web Interface quality reporting sample, we would be able to notify ACOs earlier as to whether they exceed the 20 percent threshold, and ACOs could then use this information to decide whether to report quality data for the performance year. Therefore, for performance year 2018 and subsequent performance years, we proposed to determine the percentage of an ACO’s assigned beneficiaries that reside in an area affected by an extreme and uncontrollable circumstance using the list of assigned beneficiaries used to generate the Web Interface quality reporting sample. We indicated that we E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations could use this assignment list report regardless of the date(s) the natural disaster occurred. The assignment list report provides us with a list of beneficiaries who have received the plurality of their primary care services from ACO professionals in the ACO at a specific point in time. As this is the list that is used to determine the quality reporting sample, we believe it is appropriate to use the same list to determine how many of the ACO’s beneficiaries reside in an area affected by a disaster, such that the ACO’s ability to report quality data could be compromised. We proposed to revise § 425.502(f) to reflect this proposal for performance year 2018 and subsequent years. In the Shared Savings Program IFC (82 FR 60916), we described the policies under the MIPS APM scoring standard that would apply for performance year 2017 for MIPS eligible clinicians in an ACO that did not completely report quality. The existing tracks of the Shared Savings Program (Track 1, Track 2 and Track 3), and the Track 1+ Model are all MIPS APMs under the APM scoring standard.35 If finalized, we expect the BASIC track and ENHANCED track (based on Track 3) proposed in the August 2018 proposed rule would similarly be considered MIPS APMs under the APM scoring standard. In the August 2018 proposed rule (83 FR 41902), we noted, for purposes of the APM scoring standard, MIPS eligible clinicians in an ACO that has been affected by an extreme and uncontrollable circumstance and does not report quality for a performance year, and therefore, receives the mean ACO quality score under the Shared Savings Program, would have the MIPS quality performance category reweighted to zero percent resulting in MIPS performance category weighting of 75 percent for the Promoting Interoperability performance category and 25 percent for the Improvement Activities performance category under the APM scoring standard per our policy at § 414.1370(h)(5)(i)(B). In the event an ACO that has been affected by an extreme and uncontrollable circumstance is able to completely and accurately report all quality measures for a performance year, and therefore receives the higher of the ACO’s quality performance score or the mean quality performance score under the Shared Savings Program, we would not 35 See, for example Alternative Payment Models in the Quality Payment Program as of February 2018, available at https://www.cms.gov/Medicare/ Quality-Payment-Program/Resource-Library/ Comprehensive-List-of-APMs.pdf. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 reweight the MIPS quality performance category to zero percent under the APM scoring standard. Additionally, unless otherwise excepted, the ACO participants will receive a Promoting Interoperability (PI) (formerly called Advancing Care Information (ACI)) performance category score under the APM scoring standard based on their reporting, which could further increase their final score under MIPS. We proposed to revise § 425.502(f) to extend the policies established for performance year 2017 to performance year 2018 and subsequent performance years. Specifically, we proposed that for performance year 2018 and subsequent performance years, including the applicable quality data reporting period for the performance year if the reporting period is not extended, in the event that we determine that 20 percent or more of an ACO’s assigned beneficiaries, as determined using the list of beneficiaries used to generate the Web Interface quality reporting sample, reside in an area that is affected by an extreme and uncontrollable circumstance, as determined under the Quality Payment Program, or that the ACO’s legal entity is located in such an area, we would use the following approach to calculate the ACO’s quality performance score as specified in proposed revisions to paragraphs (e) and (f) of § 425.502. • The ACO’s minimum quality score would be set to equal the mean quality performance score for all Shared Savings Program ACOs for the applicable performance year. • If the ACO is able to completely and accurately report all quality measures, we would use the higher of the ACO’s quality performance score or the mean quality performance score for all Shared Savings Program ACOs. If the ACO’s quality performance score is used, the ACO would also be eligible for quality improvement points. • If the ACO receives the mean Shared Savings Program quality performance score, the ACO would not be eligible for bonus points awarded based on quality improvement during the applicable performance year. • If an ACO receives the mean Shared Savings Program ACO quality performance score for a performance year, in the next performance year for which the ACO reports quality data and receives a quality performance score based on its own performance, we would measure quality improvement based on a comparison between the ACO’s performance in that year and in the most recently available prior performance year in which the ACO reported quality. Under this approach, PO 00000 Frm 00137 Fmt 4701 Sfmt 4700 59971 the comparison would continue to be between consecutive years of quality reporting, but these years may not be consecutive calendar years. Additionally, we proposed to address the possibility that ACOs that have a 6month performance year (or performance period) during 2019 may be affected by extreme and uncontrollable circumstances. In this final rule, we are addressing the proposals specific to the 6-month performance year from January 1, 2019 through June 30, 2019. In a forthcoming final rule, we anticipate discussing comments received on the proposals related to policies for the 6-month performance year from July 1, 2019 through December 31, 2019, and the performance period from January 1, 2019 through June 30, 2019, for ACOs that terminate their agreement effective June 30, 2019, and enter a new agreement period starting on July 1, 2019. We anticipate this discussion will include a description of the applicability of policies for addressing extreme and uncontrollable circumstances. As described in section II.A.7 of the August 2018 proposed rule, we proposed to use 12 months of data, based on the calendar year, to determine quality performance for the 6-month performance year from January 2019 through June 2019 (83 FR 41856 through 41858). We explained our belief that it is necessary to account for disasters occurring in any month(s) of CY 2019 for ACOs participating in a 6-month performance year during 2019 regardless of whether the ACO is actively participating in the Shared Savings Program at the time of the disaster. Therefore, for ACOs with a 6month performance year from January 1, 2019 through June 30, 2019, affected by a disaster in any month of 2019, we would use the alternative scoring methodology specified in § 425.502(f) to determine the quality performance score for the 2019 quality reporting period, if the reporting period is not extended. For example, assume that an ACO participates in the Shared Savings Program for a 6-month performance year from January 1, 2019 through June 30, 2019, and does not continue its participation in the program for a new agreement period beginning July 1, 2019 (as proposed). Further assume that we determine that 20 percent or more of the ACO’s assigned beneficiaries, as determined using the list of beneficiaries used to generate the Web Interface quality reporting sample, reside in an area that is affected by an extreme and uncontrollable circumstance, as determined under the E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59972 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations Quality Payment Program, in September 2019. The ACO’s quality performance score for the 2019 reporting period would be adjusted according to the policies in § 425.502(f). We proposed to specify the applicability of the alternative scoring methodology in § 425.502(f) for the 6month performance year from January 1, 2019 through June 30, 2019, in the proposed new section of the regulations at § 425.609(d). We solicited comments on the proposed policies for assessing the quality performance of ACOs affected by an extreme or uncontrollable circumstance during performance year 2018 and subsequent years, including the applicable quality data reporting period for the performance year, unless the reporting period is extended. Comment: One commenter incorrectly stated that CMS proposed to continue to use a threshold of 25 percent to determine the applicability of the proposed alternative quality scoring policies (rather than the actual 20 percent proposed) and noted that they agreed that this threshold was reasonable. This commenter also suggested that CMS consider other percentage thresholds, such as 5 percent or 10 percent, as test cases. The same commenter also encouraged CMS to look at the percentage of an ACO’s physicians and other health clinicians located in an impacted area as another means of determining which ACOs should be automatically eligible for the alternative quality scoring policy. This commenter suggested, for example, using a threshold of 50 percent of NPIs located in an impacted area, based on the practice locations listed in the Provider Enrollment, Chain, and Ownership System (PECOS). Response: We are finalizing our proposal to continue to use 20 percent of assigned beneficiaries residing in a disaster-affected as one of the criteria for determining whether an ACO is eligible for the alternative quality scoring methodology. We will continue to monitor this criterion as we gain more experience with these policies. However, at present we believe that the 20 percent threshold, which was influenced by considerations related to ensuring a sufficient population size to allow affected ACOs to fully report on quality, remains a reasonable level. While we considered the commenter’s suggestion to expand the criteria for identifying affected ACOs to include ACOs for which 50 percent or more of the NPIs billing under the ACO participant TINs are located in an impacted area, we believe that including this additional criterion would create VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 additional operational complexity and less transparency as we do not currently include information on the location of ACO providers/suppliers in program reports. Comment: Several commenters stated that the proposed policy of using the higher of an ACO’s own quality score in the affected year or the national mean score unfairly penalizes ACOs that have had historically high quality performance. One commenter also noted that this approach could unfairly reward ACOs with historically low quality performance to the detriment of the Medicare Trust Funds. These commenters recommended that CMS should adopt an approach that considers an ACO’s own quality score from one or more prior years, if available. Some of the commenters explained this approach would be similar to a policy used in Medicare Advantage. Commenters offered various suggestions on how to implement a policy that considers an ACO’s historic quality performance. A few commenters recommended that CMS use the highest of the ACO’s quality score for the affected performance year, the ACO’s quality score for the prior performance year (if available), or the national mean quality score. One commenter recommended following this approach for each individual quality measure. Suggestions from other commenters included: Using the higher of the ACO’s average quality score for the prior two years and the national mean for ACOs in their third or subsequent year in the program and using the national average score for ACOs in their first or second year in the program; Using the higher of the affected year quality score and the prior year quality score, if one is available, and otherwise using the higher of the affected year score and the national mean score; Using the ACO’s historical quality performance instead of the mean when an ACO is in its third or subsequent performance year in the program. Several commenters also recommended that the proposed policies in this section be extended to include all ACOs affected by a natural disaster, not just those that cannot report quality data. A few commenters provided suggestive evidence that quality outcome measures such as readmission measures may be subject to immediate and significant impacts in the event of a natural disaster, which could have an adverse impact on an ACO’s quality score, particularly given the non-linear nature of the program’s quality scoring methodology under which an ACO receives zero points on PO 00000 Frm 00138 Fmt 4701 Sfmt 4700 a measure if it falls below the 30th percentile. Several commenters requested that that those ACOs whose scores on readmissions measures (ACO– 8, all-cause readmissions and ACO–35, SNF readmissions) fall below the 30th percentile should be eligible to have their quality score adjusted to account for the natural disaster. Response: We acknowledge that for some ACOs, the mean quality score could be lower, or higher, than the score those ACOs would have received in the absence of a disaster. However, we have concerns with the recommended alternatives which would potentially apply an ACO’s score from the prior year or apply a score that is an average of prior year scores, particularly for ACOs in their early years of participation in the Shared Savings Program and for which the prior years may have included a higher number of pay-for-reporting measures, thus making the quality scores incomparable. Likewise, in section III.F.1.b. of this final rule we are finalizing several quality measures for use beginning in performance year 2019. These measures will be pay-for-reporting for the first 2 years of use (2019 and 2020). All else being equal, the addition of these new pay-for-reporting measures will increase ACOs’ quality scores. Also, we note that ACO quality performance can vary from year to year and the fact that an ACO had a high quality score in prior years does not necessarily guarantee that the ACO would have had an above average score in the affected year in the absence of the natural disaster. Lastly, we would remind commenters that the national mean quality score includes the quality scores of 100 percent earned by ACOs in their first performance year, thus increasing the mean. For these reasons, we are declining at this time to adopt commenters’ recommendations that we consider prior year quality scores as part of determining the quality performance scores of ACOs affected by extreme and uncontrollable circumstances and are finalizing the proposed policy. We are also declining to adopt the commenter’s recommendation to give special consideration to ACOs based on their performance on the ACO–8 and ACO– 35 readmissions measures. We would also like to clarify that both the policy that we finalized for performance year 2017 in the Shared Savings Program IFC and the policy we are finalizing in this rule for performance year 2018 and subsequent performance years would apply to all ACOs deemed to be affected by an extreme and uncontrollable circumstance (20 percent or more of assigned beneficiaries residing in an E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations affected area or legal entity located in such an area), including those ACOs that were able to report quality and those for which scores on ACO–8 and ACO–35 fell below the 30th percentile. We will continue to monitor quality performance among ACOs affected by extreme and uncontrollable circumstances, and as we gain more experience will consider whether any changes to the finalized policy are warranted. Comment: One commenter agreed with setting a disaster-affected ACO’s quality score to the national mean but opposed using the mean score to calculate ‘‘future benchmarks or subsequent year thresholds until complete and accurate reporting can be achieved.’’ They noted that ‘‘setting quality benchmarks to an artificial mean is not a valid approach to determine legitimate savings and losses.’’ Response: We clarify that ACOs’ quality performance scores are not used to calculate quality measure benchmarks. Rather, the quality measure benchmarks are calculating using actual ACO performance and all other available and applicable Medicare FFS data. Comment: One commenter recommended that all affected ACOs should receive the higher of the 2018 or 2019 Star Rating for each CAHPS measure. Response: We note that the Shared Savings Program does not provide a Star Rating to ACOs based on their CAHPS performance. Star Ratings are used for Medicare Advantage and Medicare Prescription Drug plans to provide quality and performance information to Medicare beneficiaries to assist them in choosing their health and drug services and, solely for Medicare Advantage plans, to implement the quality bonus payment adopted by Congress in the Patient Protection and Affordable Care Act. We believe that incorporating Star Ratings into the Shared Savings Program would need to be part of a larger effort that was not contemplated in the August 2018 proposed rule. In contrast, we believe our proposal of using the higher of an ACO’s own calculated quality score or the mean quality score serves as a way to mitigate negative impacts for disaster-affected ACOs in manner that can be readily incorporated into the existing structure of the Shared Savings Program quality scoring methodology. Comment: A few commenters recommended that CMS remove claims associated with disaster-impacted beneficiaries and time periods or claims with disaster payment modifier codes when calculating the numerator and denominator of the readmissions VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 measures and other claims-based quality measures. Response: As we describe in section V.B.2.b. of this final rule, we have examined the use of existing disaster payment modifiers during 2017 and have found their utilization to be low overall and to vary across ACOs, including those with comparably high shares of beneficiaries residing in disaster affected areas. Therefore, we have concerns that these codes would not serve as a useful means for comprehensively identifying relevant claims. We also have concerns about removing claims for beneficiaries residing in affected areas during affected time periods. In addition to adding considerable complexity, this approach could lead to the elimination of a large number of claims for some ACOs. This could lead to bias if the claims removed are systematically different from other claims for reasons apart from the natural disaster, such as because they are concentrated in a specific geographic area or time period and may also make it more difficult for CMS to provide an oversample of beneficiaries to ACOs for the CMS Web Interface sample. Comment: One commenter requested that CMS provide additional clarity before finalizing any of the policies for extreme and uncontrollable circumstances proposed in the August 2018 proposed rule. In particular, the commenter requested that CMS provide additional clarification on how the agency would determine and announce whether the extreme and uncontrollable circumstances policies would apply or if the reporting period would be extended. Response: We intend to make an initial determination about whether an ACO meets the criteria for being considered a disaster-affected ACO after quarter 3 assignment has been determined and before the start of the quality reporting period. We will make the final determination with respect to affected ACOs after the end of the calendar year in order to capture any additional extreme and uncontrollable circumstances that may occur in the remainder of the year or during the quality reporting period, if not extended. We will continue to use the quarter 3 assignment list as the basis for this final determination. In the event that CMS decides to extend the quality reporting period, we would provide notification to ACOs through existing communication channels such as the Shared Savings Program newsletter or an email blast. We also note that if an ACO is determined to be an affected ACO as a result of an extreme or uncontrollable circumstance during the PO 00000 Frm 00139 Fmt 4701 Sfmt 4700 59973 performance year, the alternative quality scoring methodology would apply, regardless of whether the quality reporting period is extended. Comment: One commenter recommended that CMS adopt the same period as any Declaration of Emergency by the Secretary when determining the applicable time period for an extreme and uncontrollable circumstance instead of an alternative period selected by CMS that may not be as well-aligned with the reality of health services instability for areas under a declaration of emergency. Another commenter encouraged CMS to be transparent regarding the criteria used to determine the applicable time period and to work closely with Medicare Administrative Contractors and the Federal Emergency Management Agency to communicate these policies to ACOs. Response: We are finalizing our proposals for extreme and uncontrollable circumstances, including our proposal that CMS will have the sole discretion to determine the time period during which an extreme and uncontrollable circumstance occurred. Although we are not adopting fixed criteria for determining the applicable time periods, we note that for performance year 2017 we used the time periods associated with public health emergencies declared by the Secretary and listed on the CMS Emergency Response and Recovery website (now renamed the Emergency Preparedness & Response Operations website at https:// www.cms.gov/About-CMS/AgencyInformation/Emergency/EPRO/EPROHome.html). We anticipate continuing this practice, which we believe to be transparent, going forward. Furthermore, for events for which the public health emergency declaration spans calendar years, we intend to treat the portion of the period falling within each year as if it were a separate event for purposes of identifying ACOs eligible for the alternative quality scoring methodology and for computing any adjustment to shared losses. Comment: One commenter expressed concerns about what they described as CMS’ ‘‘one-size-fits-all’’ approach for determining the time period during which an ACO would be subject to the extreme and uncontrollable circumstances policies. They encouraged CMS to allow ACOs an opportunity to request relief from shared losses and negative quality adjustments over a longer period of time, up to a full performance year, to be evaluated by CMS on a case-by-case basis. The commenter noted that the impact of a disaster occurring early in the year may have a different impact E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59974 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations than one occurring later in the year and there may be long-lasting effects, which should not have counted against affected ACOs. They stated that the hardship exemption, which would be approved by CMS on a case-by-case basis, would have limited effect on the Trust Funds, but would be important for the integrity of the program by establishing a formal process for ACOs to request an exemption based on extenuating circumstances. Response: We have elected to adopt automatic policies to address extreme and uncontrollable circumstances in lieu of hardship requests that must be considered on a case-by-case basis in order to increase certainty and reduce administrative burden for both ACOs and CMS. We will continue to monitor the impact of the policies that we are finalizing in this rule, and as we gain more experience, if warranted, we will propose additional modifications through future notice and comment rulemaking. After considering the comments received, we are finalizing our proposals to extend the policies for determining the quality scores for ACOs affected by extreme and uncontrollable circumstances established for performance year 2017 to performance year 2018 and subsequent performance years. Specifically, we are revising §§ 425.502(e) and 425.502(f) to state that for performance year 2018 and subsequent performance years, including the applicable quality data reporting period for the performance year, if the reporting period is not extended, in the event that we determine that 20 percent or more of an ACO’s assigned beneficiaries, as determined using the list of assigned beneficiaries used to generate the Web Interface quality reporting sample, reside in an area that is affected by an extreme and uncontrollable circumstance, as determined under the Quality Payment Program, or that the ACO’s legal entity is located in such an area, we will use the following approach to calculate the ACO’s quality performance score: • The ACO’s minimum quality score will be set to equal the mean quality performance score for all Shared Savings Program ACOs for the applicable performance year. • If the ACO is able to completely and accurately report all quality measures, we will use the higher of the ACO’s quality performance score or the mean quality performance score for all Shared Savings Program ACOs. If the ACO’s quality performance score is used, the ACO will also be eligible for quality improvement points. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 • If the ACO receives the mean Shared Savings Program quality performance score, the ACO will not be eligible for bonus points awarded based on quality improvement during the applicable performance year. • If an ACO receives the mean Shared Savings Program ACO quality performance score for a performance year, in the next performance year for which the ACO reports quality data and receives a quality performance score based on its own performance, we will measure quality improvement based on a comparison between the ACO’s performance in that year and in the most recently available prior performance year in which the ACO reported quality. We clarify that if an ACO reports quality data in a year in which it is affected by an extreme and uncontrollable circumstance, but receives the national mean quality score, we will use the ACO’s own quality performance score to determine quality improvement bonus points in the following year. For example, if an ACO reported quality data in years 1, 2, and 3 of an agreement period, but received the national mean quality score in year 2 as the result of an extreme or uncontrollable circumstance, we would determine quality improvement bonus points for year 3 by comparing the ACO’s year 3 quality score with its year 2 score. If the ACO received the mean score in year 2 because it did not report quality, we would compare year 3 with year 1 to determine the bonus points for year 3. We also want to clarify one point regarding the interaction between this alternative quality scoring methodology and MIPS. As we noted above, the MIPS quality performance category is reweighted to zero if a disaster-affected ACO receives the mean quality score under the Shared Savings Program’s extreme and uncontrollable circumstance policy, because it did not or could not report quality data at the ACO (APM Entity) level, regardless of whether or not any of the ACOs participant TINs reported quality outside the ACO. This reweighting under MIPS results in MIPS performance category weighting of 75 percent for the PI performance category and 25 percent for IA performance category. If, for any reason, the PI performance category also is reweighted to zero, which could be more likely when there is a disaster, there would be only one performance category triggering the policy under which the ACO in question would receive a neutral (threshold) MIPS score, as per § 414.1380(c) (see discussion at 83 FR PO 00000 Frm 00140 Fmt 4701 Sfmt 4700 53778). If any of the ACO’s participant TINs do report PI, then the TIN or TINs’ PI performance category scores will be used to score the ACO under the MIPS scoring standard, the PI performance category will not be reweighted, and the policy to assign a neutral (threshold) MIPS score will not be triggered. (b) Mitigating Shared Losses for ACOs Participating in a Performance-Based Risk Track In the Shared Savings Program IFC (82 FR 60916) we modified the payment methodology for performance year 2017 for performance-based risk tracks established under the authority of section 1899(i) of the Act, to mitigate shared losses owed by ACOs affected by extreme and uncontrollable circumstances during 2017. Under this approach, we reduced the ACO’s shared losses, if any, determined to be owed for performance year 2017 under the existing methodology for calculating shared losses in the Shared Savings Program regulations at 42 CFR part 425 subpart G by an amount determined by multiplying the shared losses by two factors: (1) The percentage of the total months in the performance year affected by an extreme and uncontrollable circumstance; and (2) the percentage of the ACO’s assigned beneficiaries who resided in an area affected by an extreme and uncontrollable circumstance. For performance year 2017, we determined the percentage of the ACO’s performance year assigned beneficiary population that was affected by the disaster based on the final list of beneficiaries assigned to the ACO for the performance year. For example, assume that an ACO was determined to owe shared losses of $100,000 for performance year 2017, a disaster was declared for October through December during the performance year, and 25 percent of the ACO’s assigned beneficiaries resided in the disaster area. In this scenario, we would have adjusted the ACO’s shared losses in the following manner: $100,000¥($100,000 × 0.25 × 0.25) = $100,000¥$6,250 = $93,750. The policies for performance year 2017 are specified in paragraph (i) in § 425.606 for ACOs under Track 2 and § 425.610 for ACOs under Track 3. In the August 2018 proposed rule (83 FR 41903), we stated our belief that it would be appropriate to continue to apply these policies in performance year 2018 and subsequent years to address stakeholders’ concerns that ACOs participating under a performance-based risk track could be held responsible for sharing losses with the Medicare program resulting from catastrophic events outside the ACO’s control given E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations the increase in utilization, difficulty of coordinating care for patient populations leaving the impacted areas, and the use of natural disaster payment modifiers making it difficult to identify whether a claim would otherwise have been denied under normal Medicare FFS rules. Absent this relief, we believe that ACOs participating in performancebased risk tracks might reconsider whether they are able to continue their participation in the Shared Savings Program under a performance-based risk track. The approach we adopted for performance year 2017 in the Shared Savings Program IFC, and which we proposed to continue for performance year 2018 and subsequent years, balances the need to offer relief to affected ACOs with the need to continue to hold those ACOs accountable for losses incurred during the months in which there was no applicable disaster declaration and for the portion of their final assigned beneficiary population that was outside the area affected by the disaster. In the August 2018 proposed rule, we explained our belief that, consistent with the policy adopted for performance year 2017 in the Shared Savings Program IFC, it would be appropriate to continue to use the final assignment list report for the performance year for purposes of this calculation. This final assignment list report would be available at the time we conduct final reconciliation and provides the most complete information regarding the extent to which an ACO’s assigned beneficiary population was affected by a disaster. Additionally, we proposed to also address the possibility that ACOs that have a 6-month performance year during 2019 may be affected by extreme and uncontrollable circumstances. In this final rule, we are addressing the proposals specific to the 6-month performance year from January 1, 2019 through June 30, 2019. In a forthcoming final rule, we anticipate discussing comments received on the proposals related to policies for the 6-month performance year from July 1, 2019 through December 31, 2019, and the performance period from January 1, 2019 through June 30, 2019 for ACOs that terminate their agreement effective June 30, 2019, and enter a new agreement period starting on July 1, 2019. We anticipate this discussion will include a description of the applicability of policies for determining shared losses for ACOs affected by extreme and uncontrollable circumstances. As described in section II.A.7. of the August 2018 proposed rule (83 FR 41849 through 41853) and the proposed VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 provision at § 425.609, we proposed to use 12 months of expenditure data, based on the calendar year, to perform financial reconciliation for the 6-month performance year from January 1, 2019 through June 30, 2019. Accordingly, for ACOs participating in a 6-month performance year during the first half of 2019, we believed it would be necessary to account for disasters occurring in any month(s) of CY 2019, regardless of whether the ACO is actively participating in the Shared Savings Program at the time of the disaster. For ACOs with a 6-month performance year that are affected by an extreme or uncontrollable circumstance during CY 2019, we proposed to first determine shared losses for the ACO over the full calendar year, adjust the shared losses for extreme and uncontrollable circumstances, and then determine the portion of shared losses for the 6-month performance year according to the methodology proposed under § 425.609. For example, assume that: A disaster was declared for October 2019 through December 2019; an ACO is being reconciled for its participation during the performance year from January 1, 2019 through June 30, 2019; the ACO is determined to have shared losses of $100,000 for CY 2019; and 25 percent of the ACO’s assigned beneficiaries reside in the disaster area. In this scenario, we would adjust the ACO’s losses in the following manner: $100,000¥($100,000 × 0.25 × 0.25) = $100,000¥$6,250 = $93,750, then we would multiply these losses by the portion of the year the ACO participated = $93,750 × 0.5 = $46,875. Therefore, we proposed to amend §§ 425.606(i) and 425.610(i) to extend the policies regarding extreme and uncontrollable circumstances that were established for performance year 2017 to performance year 2018 and subsequent years. In addition, we proposed to include a provision at § 425.609(d) to provide that the policies on extreme and uncontrollable circumstances would apply to the determination of shared losses for ACOs participating in a 6month performance year during 2019. In the August 2018 proposed rule (83 FR 41904), we noted that to the extent that our proposal to extend the policies adopted in the Shared Savings Program IFC to 2018 and subsequent performance years constitutes a proposal to change the payment methodology for 2018 after the start of the performance year, we believe that consistent with section 1871(e)(1)(A)(ii) of the Act, and for the reasons discussed in section II.E.4 of the August 2018 proposed rule (83 FR 41899 through 41906), it would be contrary to the PO 00000 Frm 00141 Fmt 4701 Sfmt 4700 59975 public interest not to propose to establish a policy under which we would have the authority to adjust the shared losses calculated for ACOs in Track 2 and Track 3 for performance year 2018 to reflect the impact of any extreme or uncontrollable circumstances that may occur during the year. We also explained that these proposed policies would not change the status of those payment models that meet the criteria to be Advanced APMs under the Quality Payment Program (see § 414.1415). Our proposed policies would reduce the amount of shared losses owed by ACOs affected by a disaster, but the overall financial risk under the payment model would not change and participating ACOs would still remain at risk for an amount of shared losses in excess of the Advanced APM generally applicable nominal amount standard. Additionally, these policies would not prevent an eligible clinician from satisfying the requirements to become a QP for purposes of the APM Incentive Payment (available for payment years through 2024) or higher physician fee schedule updates (for payment years beginning in 2026) under the Quality Payment Program. We also emphasized that all ACOs would continue to be entitled to share in any savings they may achieve for a performance year. ACOs in all tracks of the program will continue to receive shared savings payments, if any, as determined under subpart G of the regulations. The calculation of savings and the determination of shared savings payment amounts for a performance year would not be affected by the proposed policies to address extreme and uncontrollable circumstances, except that the quality performance score for an affected ACO may be adjusted as described in section II.E.4 of the proposed rule. We solicited comments on the proposed policies for assessing the financial performance of ACOs affected by an extreme or uncontrollable circumstance during performance year 2018 and subsequent years. Comment: Several commenters noted that ACOs are likely to experience increased expenditures as the result of a natural disaster. One commenter noted that studies have shown that natural disasters materially increase Medicare costs per beneficiary. A few other commenters noted that costs can increase because of the impact of the disaster on beneficiaries’ health, safety and anxiety causing increased utilization of services but also because waivers effected during declared Public E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59976 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations Health Emergencies relax Medicare payment rules allowing more services to be covered than usual. Another commenter stated that an ACO may experience expenditure increases because its assigned beneficiaries migrate to areas with higher FFS payment rates in search of health care services in the wake of a natural disaster. This commenter noted that ACOs based in Puerto Rico could be significantly affected given that after a natural disaster many beneficiaries migrate to the U.S. mainland where the FFS payment rates are substantially higher than on the island. Several commenters shared the opinion that the proposed policy of adjusting shared losses adequately addresses the situation of ACOs that would have had shared losses in the absence of a natural disaster, but had higher shared losses as the result of the disaster. However, they expressed concern that the policy does not provide relief to ACOs that receive a smaller shared savings payment as a result of the disaster or ACOs for which an expenditure increase resulting from a disaster causes the ACO to fall short of its MSR (and thus miss out on shared savings entirely) or to exceed its MLR (and thus owe shared losses when it otherwise would not have had shared losses). A few commenters recommended addressing this issue by modifying the update that is applied to an ACO’s benchmark for a performance year that is affected by an extreme and uncontrollable circumstance. For example, these commenters recommended that CMS apply a growth rate that is the higher of the national growth rate for assignable beneficiaries or the regional growth rate for assignable beneficiaries (excluding an ACO’s own assigned beneficiaries). They suggested that their recommendation should be used instead of the ‘‘current policy’’ for accounting for the impact of disasters on performance year expenditures, which they believed relies on the use of natural disaster payment modifiers. A few other commenters recommended that CMS use a blend of national and regional expenditure growth rates to update the benchmark as proposed in the August 2018 rule in ‘‘normal times’’ but use a purely regional growth rate in the event of an extreme and uncontrollable circumstance. The same commenters also suggested that CMS remove claims associated with disaster-affected beneficiaries during the relevant time periods or claims with a natural disaster payment modifier code, pending changes to improve these codes, when VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 calculating performance or benchmark year expenditures. It was unclear, however, whether they meant for these claims adjustments to be made instead of or in addition to their recommended changes to the update factors applied to the historical benchmark. Several commenters raised concerns about the existing natural disaster modifier codes and whether, in their current form, they could be used to try to capture the negative impact on an ACO’s performance. They noted that some health care providers may not be aware of the existence of such codes and that the codes may not be used properly due to lack of training and competing priorities during an emergency event. They also noted that the existing codes do not capture instances of ‘‘unsafe place of discharge’’, which they believe is a common reason for lengths of stay to be increased during a disaster and recommended that CMS expand existing modifier codes or add a new code to cover this circumstance. A few commenters recommended providing proper education on the use of such codes, which would allow these codes to serve as a more accurate means for identifying the impacts of natural disasters. Another commenter recommended that CMS allow an additional 6 to 12 months for providers to submit such codes to be considered in expenditure calculations. Response: We are finalizing our proposed approach to mitigate shared losses for ACOs affected by extreme and uncontrollable circumstances without modification in this final rule. We acknowledge commenters’ concerns regarding the potential impact of extreme and uncontrollable circumstances on the financial performance of ACOs that do not owe shared losses and we appreciate the commenters’ recommendations for how to mitigate these impacts. However, because we did not propose to make any adjustments under these circumstances, these recommendations are outside the scope of this rulemaking. We will continue to monitor the financial performance of ACOs affected by extreme and uncontrollable circumstances, and as we gain more experience will consider whether any changes to our policies for mitigating the effects of extreme and uncontrollable circumstances are warranted. Furthermore, we note that although we considered the use of natural disaster payment modifiers in developing the original extreme and uncontrollable circumstances policy for performance year 2017, we did not adopt a policy that used such codes in PO 00000 Frm 00142 Fmt 4701 Sfmt 4700 the Shared Savings Program IFC, nor did we propose in the August 2018 proposed rule to use such codes to adjust benchmark or performance year expenditure calculations for performance year 2018 or subsequent years. We have examined the existing natural disaster payment modifiers (specifically the ‘‘DR’’ condition code used on institutional claims and the ‘‘CR’’ modifier code used on Part B institutional and non-institutional claims) in 2017 claims for ACO assigned beneficiaries. We found that these codes were not widely or consistently used and that there appears to be variation in their use among ACOs. For example, among 69 ACOs with 90 percent or more of assigned beneficiaries residing in a disaster affected area, we found that only 0.01 percent of institutional claims and only 0.0006 percent of noninstitutional claims included such a code. Among this same group of ACOs, the total number of claims (institutional or non-institutional) containing one of these codes ranged from 0 to 155 with a mean of 14 and a median of 8. In a separate analysis, we found that claims completion rates were comparable in disaster-affected and non-affected years which suggests that the low levels of modifier usage are not necessarily due to delayed claim submission. Based on these analyses, as well as the comments offered in response to the August 2018 proposed rule, we also have concerns that these codes would not serve as a useful means for comprehensively identifying relevant claims. As we described in the August 2018 proposed rule, and have recounted in this final rule, we have some concerns about removing claims for affected beneficiaries and time periods from benchmark year expenditure calculations. As we develop additional experience, we may revisit this policy and, if warranted, propose modifications to performance or benchmark year expenditure calculations for ACOs affected by extreme and uncontrollable circumstances through further notice and comment rulemaking. We also note that, although the policies regarding extreme and uncontrollable circumstances we are finalizing in this final rule do not include an explicit adjustment to the shared savings payment of a disasteraffected ACO, our alternative methodology for quality scoring can indirectly increase an ACO’s shared savings payment. In performance year 2017, 62 of 117 disaster-affected ACOs received the national mean quality score, as it was higher than the score the E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations amozie on DSK3GDR082PROD with RULES3 ACO would have received in the absence of the policy. After considering the comments received, we are finalizing our proposal to extend the policy for mitigating shared losses owed by ACOs affected by extreme and uncontrollable circumstances established for performance year 2017 to performance year 2018 and subsequent performance years. We are revising §§ 425.606(i) and 425.610(i) to indicate that we will reduce the amount of shared losses calculated for the performance year by an amount determined by multiplying (1) the percentage of the total months in the performance year affected by an extreme and uncontrollable circumstance; and (2) the percentage of the ACO’s assigned beneficiaries who reside in an area affected by an extreme and uncontrollable circumstance. We are also finalizing our proposal, through a new provision at § 425.609(d), to adjust shared losses for ACOs with a 6month performance year from January 1, 2019 through June 30, 2019. For ACOs in a 6-month performance year we will first determine shared losses for the ACO over the full calendar year, reduce the ACO’s shared losses for the calendar year for extreme and uncontrollable circumstances, and then determine the portion of shared losses for the 6-month performance year. (c) Determination of Historical Benchmarks for ACOs in Affected Areas In the Shared Savings Program IFC, we sought comment on how to address the impact of extreme and uncontrollable circumstances on the expenditures for an ACO’s assigned beneficiary population for purposes of determining the benchmark (82 FR 60917). As we explained in the Shared Savings Program IFC (82 FR 60913), the impact of disasters on an ACO’s financial performance could be unpredictable as a result of changes in utilization and cost of services furnished to the Medicare beneficiaries it serves. In some cases, ACO participants might be unable to coordinate care because of migration of patient populations leaving the impacted areas. On the other hand, patient populations remaining in impacted areas might receive fewer services and have lower overall costs to the extent that healthcare providers are unable to reopen their offices because they lack power and water or have limited access to fuel for operating alternate power generators. Significant changes in costs incurred, whether increased or decreased, as a result of an extreme or uncontrollable circumstance may impact the benchmark determined VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 for the ACO’s subsequent agreement period in the Shared Savings Program, as performance years of the current agreement period become the historical benchmark years for the subsequent agreement period. An increase in expenditures for a particular calendar year would result in a higher benchmark value when the same calendar year is used to determine the ACO’s historical benchmark, and in calculating adjustments to the rebased benchmark based on regional FFS expenditures. Likewise, a decrease in expenditures for a particular calendar year would result in a lower benchmark value when the same calendar year is used to determine the ACO’s historical benchmark. While considering options for adjusting ACOs’ historical benchmarks to account for disasters occurring during a benchmark year, we considered the effect that the proposed regional factors, that are discussed in section II.D.3. of the August 2018 proposed rule (83 FR 41886 through 41891), might have on the historical benchmarks for ACOs located in a disaster area. After review, we explained that we believe that when regional factors are applied to an ACO’s historical benchmark, the regional factors would inherently adjust for variations in expenditures from year to year, and thus would also adjust for regional variations in expenditures related to extreme and uncontrollable circumstances. For example, assume that an ACO experienced a reduction in beneficiary expenditures in performance year 2017 because a portion of its assigned beneficiaries resided in counties that were impacted by a disaster. Then, also assume expenditures returned to their previously higher level in 2018 and this ACO subsequently renewed its ACO participation agreement in 2020. In 2020, when the ACO’s historical benchmark would be reset (rebased), the expenditures for 2017 (now a historical benchmark year) would be subject to a higher regional trend factor because expenditures increased back to the expected level in 2018, which would increase the 2017 benchmark year expenditures. Additionally, this ACO could also have its historical benchmark increased even further as a result of its performance compared to others in its region, as reflected in the regional adjustment to the ACO’s historical benchmark. In contrast, consider an ACO that experienced an increase in beneficiary expenditures in performance year 2017 because a portion of its assigned beneficiaries resided in counties that were impacted by a disaster. Then, assume expenditures PO 00000 Frm 00143 Fmt 4701 Sfmt 4700 59977 returned to their previously lower level in 2018 and this ACO renewed its ACO participation agreement in 2020. In 2020, when the ACO’s historical benchmark would be reset, the expenditures for 2017 would be subject to a lower regional trend factor because expenditures decreased back to the expected level in 2018, which would decrease the 2017 benchmark year expenditures. Additionally, this ACO could also have its historical benchmark decreased further as a result of its performance compared to others in its region, as reflected in the regional adjustment to the ACO’s historical benchmark. Our expectation that the proposed regional factors that would be used to establish an ACO’s historical benchmark would also adjust for variations in expenditures related to extreme and uncontrollable circumstances was supported by a preliminary analysis of data for areas that were affected by the disasters that occurred in performance year 2017. Our analysis of the data showed that, as a result of the disasters in these areas, expenditure trends for the performance year appeared below projections. For these areas, the expenditures began to increase after the disaster incident period ended, but expenditures were still below expectations for the year. Based on the expenditure trends beginning to return to expected levels after the disaster period, it would be reasonable to expect that expenditures would continue to increase to expected levels in 2018. This difference between the lower than expected levels of expenditures in 2017 and a return to expected expenditures in 2018, would result in a higher regional trend factor being applied to 2017 expenditures when they are used to determine an ACO’s historical benchmark. Although our analysis for the proposed rule was performed using the proposed regional factors, we expect that our existing benchmarking methodology at § 425.603, which also incorporates regional factors in the determination of an ACO’s historical benchmark for its second or subsequent agreement period beginning in 2017 or later years, would have a similar result. In the August 2018 proposed rule (83 FR 41905), in considering whether it might be necessary to make an additional adjustment to ACOs’ historical benchmarks to account for expenditure variations related to extreme and uncontrollable circumstances, we considered an approach where we would adjust the historical benchmark by reducing the weight of expenditures for beneficiaries who resided in a disaster area during a E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59978 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations disaster period and placing a correspondingly larger weight on expenditures for beneficiaries residing outside the disaster area during the disaster period. Such an approach would be expected to proportionally increase the historical benchmark for ACOs that experienced a decrease in expenditures, and conversely proportionally decrease the historical benchmark for ACOs that experienced an increase in expenditures for their assigned beneficiaries who were impacted by a disaster. Under this approach, for each of the historical benchmark years, we would identify each ACO’s assigned beneficiaries who had resided in a disaster area during a disaster period. The portion of expenditures for these assigned beneficiaries that was impacted by the disaster would be removed from the applicable historical benchmark year(s). The removal of these expenditures from the historical benchmark year(s) would allow the historical benchmark calculations to include only expenditures that were not impacted by the disaster. We believe this methodology for calculating benchmark expenditures would adjust for expenditure increases or decreases that may occur as a result of impacts related to a disaster. We noted that if we were to implement such an adjustment to the historical benchmark, we believed it would be appropriate to avoid making minor historical benchmark adjustments for an ACO that was not significantly affected by a disaster by establishing a minimum threshold for the percentage of an ACO’s beneficiaries located in a disaster area. Based on data from 2017, quarter 3, over 80 percent of ACOs had less than 50 percent of their assigned beneficiaries residing in disaster counties, with over 75 percent having less than 10 percent of their assigned beneficiaries residing in disaster counties. Based on this data, we noted our belief that a minimum threshold of 50 percent of assigned beneficiaries residing in disaster counties could be an appropriate threshold for the adjustment to historical benchmarks because historical benchmarks are calculated based on the ACO’s entire assigned beneficiary population in each benchmark year, rather than a sample as is used for quality reporting. However, we were concerned that this methodology for calculating an adjustment might not be as accurate as the inherent adjustment that would result from applying regional factors when resetting the benchmark and may impact other expected expenditure variations occurring in the impacted VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 areas. For example, if an additional disaster adjustment were to be applied, it might have unintended impacts when expenditure truncation is applied, it might inappropriately weight and not account for expected variations in expenditures between areas that were and were not impacted by the disaster, and it might compound effects that have already been offset by the regional adjustment. In addition, the expenditures, as adjusted, may not be representative of the ACO’s actual performance and aggregate assigned beneficiary population during the benchmark period. In summary, we noted our belief that the regional factors that we had proposed to apply as part of the methodology for determining an ACO’s historical benchmark would reduce the expenditures in a historical benchmark year when they are greater than expected (relative to other historical benchmark years) as a result of a disaster and conversely increase expenditures in a historical benchmark year when they are below the expected amount. For these reasons, we believed that the proposal in section II.D.3. of the August 2018 proposed rule (83 FR 41887 through 41888) to apply regional factors when determining ACOs’ historical benchmarks, starting with an ACO’s first agreement period for agreement periods starting on July 1, 2019, and in subsequent years, would be sufficient to address any changes in expenditures during an ACO’s historical benchmark years as a result of extreme and uncontrollable circumstances, and an additional adjustment, such as the method discussed previously in this section would not appear to be necessary. However, we noted that we would continue to evaluate the impact of the 2017 disasters on ACOs’ assigned beneficiary expenditures, and that we intended to continue to consider whether it might be appropriate to make an additional adjustment to the historical benchmark to account for expenditures that may have increased or decreased in a historical benchmark year as a result of an extreme or uncontrollable circumstance. We solicited comments on these issues, including whether it is necessary to adjust ACOs’ historical benchmarks to account for extreme and uncontrollable circumstances that might occur during a benchmark year, and appropriate methods for making such benchmark adjustments. We also noted that the proposal in section II.D.3. of the August 2018 proposed rule to apply regional factors to determine ACOs’ historical benchmarks would apply starting with an ACO’s first agreement PO 00000 Frm 00144 Fmt 4701 Sfmt 4700 period for agreement periods starting on July 1, 2019, and in subsequent years and would therefore have no effect on benchmarks for ACOs in a first agreement period starting before July 1, 2019 (see 83 FR 41887). Accordingly, we solicited comments on whether and how an adjustment should be made for ACOs whose benchmarks do not reflect regional factors. We also invited comments on any additional areas where relief may be helpful or other ways to mitigate unexpected issues that may arise in the event of an extreme and uncontrollable circumstance. Comment: A few commenters noted that expenditure increases in a performance year due to a natural disaster could lead to unjustly high benchmark year expenditures in an ACO’s subsequent agreement period which could create vulnerabilities for the Trust Funds. As described in the prior section V.B.2.d.(2) of this final rule, we received a few comments recommending modifications to the update that is applied to an ACO’s benchmark for a performance year that is affected by an extreme and uncontrollable circumstance. Another commenter suggested removing claims from benchmark and performance year expenditures that have a disaster modifier code or are associated with a beneficiary residing a disaster-affected area during an affected time period. Response: As discussed in the prior section V.B.2.d.(2) of this final rule, we intend to further consider commenters’ recommendations that we address the financial impacts of extreme and uncontrollable circumstances through the update that is applied to the historical benchmark and how this approach could mitigate potential negative impacts to ACOs or to the Medicare Trust Funds for the performance year in which a disaster occurs, performance years for which there was a disaster in one or more of the benchmark years, or cases where an ACO was affected by disasters in both the benchmark period and the performance year. As described in the prior section V.B.2.d.(2) of this final rule, we have concerns about commenters’ recommendation to exclude claims with a natural disaster modifier code, or claims associated with disaster affected beneficiaries and time periods from benchmark or performance year expenditures. As we develop additional experience, we may revisit this policy and, if warranted, propose modifications to our methodology for calculating performance year or benchmark year expenditures through further notice and comment rulemaking. E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations Comment: One commenter opposed using regional factors as currently calculated by CMS to address concerns about the effect of extreme and uncontrollable circumstances on ACOs’ historical benchmarks. This commenter disagreed with CMS’ current approach, which includes ACO assigned beneficiaries when calculating regional expenditures. They stated that ‘‘[A]bsent a reform that addresses the underlying issue with the regional adjustment factor, applying it to ACOs in a region recovering from an extreme or uncontrollable circumstance will perpetuate the flaws.’’ Response: We continue to believe that the use of regional factors in establishing and updating the benchmark will provide an inherent adjustment for regional variations in expenditures related to extreme and uncontrollable circumstances. As the commenter notes, and under the June 2016 final rule, regional expenditure calculations in the Shared Savings Program are based on all assignable beneficiaries in an ACO’s regional service area including ACO assigned beneficiaries. We have detailed in that earlier rule our reasons for not excluding assigned beneficiaries from these calculations (see 81 FR 37960). Furthermore, we do not believe that inclusion of an ACO’s assigned beneficiaries would reduce the effectiveness of regional factors to inherently adjust for regional variations in expenditures related to extreme and uncontrollable circumstances as we have no reason to believe that such an event would have a differential impact on expenditures for assigned beneficiaries relative to expenditures for assignable beneficiaries that are not assigned to an ACO. After considering comments we received on the determination of historical benchmarks for ACOs in areas affected by extreme and uncontrollable circumstances, we are not making any changes to the benchmarking methodology to address such events at this time. We will continue to monitor the impact of extreme and uncontrollable circumstances on benchmark expenditures and, if applicable, the extent to which any impact is mitigated by the use of regional factors in establishing and updating the benchmark. If warranted, we will propose additional modifications to our benchmarking methodology to address the effects of extreme and uncontrollable circumstances through future notice and comment rulemaking. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 e. Program Data and Quality Measures In section II.E.5. of the August 2018 proposed rule (41906 through 41908), we solicited comments on possible changes to the quality measure set and modifications to program data shared with ACOs to support CMS’ Meaningful Measures initiative and respond to the nation’s opioid misuse epidemic. As part of the Meaningful Measures initiative, the agency’s efforts are focused on updating quality measures, reducing regulatory burden, and promoting innovation (see CMS Press Release, CMS Administrator Verma Announces New Meaningful Measures Initiative and Addresses Regulatory Reform; Promotes Innovation at LAN Summit, October 30, 2017, available at https://www.cms.gov/Newsroom/ MediaReleaseDatabase/Press-releases/ 2017-Press-releases-items/2017-1030.html). Under the Meaningful Measures initiative, we are working towards assessing performance on only those core issues that are most vital to providing high-quality care and improving patient outcomes, with an emphasis on outcome-based measures, reducing unnecessary burden on providers, and putting patients first. When we developed the quality reporting requirements under the Shared Savings Program, we considered the quality reporting requirements under other initiatives, such as the Physician Quality Reporting System (PQRS) and Million Hearts Initiative, and consulted with the measures community to ensure that the specifications for the measures used under the Shared Savings Program are up-to-date and reduce reporting burden. Since the Shared Savings Program was first established in 2012, we have not only updated the quality measure set to reduce reporting burden, but also to focus on more meaningful outcomebased measures. The most recent updates to the Shared Savings Program quality measure set were made in the CY 2017 PFS Final Rule (81 FR 80484 through 80489) to adopt the ACO measure recommendations made by the Core Quality Measures Collaborative, a multi-stakeholder group with the goal of aligning quality measures for reporting across public and private stakeholders in order to reduce provider reporting burden. Currently, more than half of the 31 Shared Savings Program quality measures are outcome-based, including— • Patient-reported outcome measures collected through the CAHPS for ACOs Survey that strengthen patient and caregiver experience; PO 00000 Frm 00145 Fmt 4701 Sfmt 4700 59979 • Outcome measures supporting care coordination and effective communication, such as unplanned admission and readmission measures; and • Intermediate outcome measures that address the effective treatment of chronic disease, such as hemoglobin A1c control for patients with diabetes and control of high blood pressure. As we explained in the August 2018 proposed rule (83 FR 41906), it is important that the quality reporting requirements under the Shared Savings Program align with the reporting requirements under other Medicare initiatives and those used by other payers in order to minimize the need for Shared Savings Program participants to devote excessive resources to understanding differences in measure specifications or engaging in duplicative reporting. We sought comment, including recommendations and input on meaningful measures, on how we may be able to further advance the quality measure set for ACO reporting, consistent with the requirement under section 1899(b)(3)(C) of the Act that the Secretary seek to improve the quality of care furnished by ACOs by specifying higher standards, new measures, or both. One particular area of focus by the Department of Health and Human Services is the opioid misuse epidemic. The Centers for Disease Control and Prevention (CDC) reports that the number of people experiencing chronic pain lasting more than 3 months is estimated to include 11 percent of the adult population. According to a 2016 CDC publication, 2 million Americans had opioid use disorder (OUD) associated with prescription opioids in 2014 (https://www.cdc.gov/ drugoverdose/prescribing/ guideline.html). Since the implementation of Medicare Part D in 2006 to cover prescription medications, the Medicare program has become the largest payer for prescription opioids in the United States (Zhou et al., 2016; https://www.ncbi.nlm.nih.gov/pmc/ articles/PMC4955937/). Safe and effective opioid prescribing for older adults is of particular importance because misuse and abuse of opioids can lead to increased adverse events in this population (for example, increased falls, fractures, hospitalization, ER visits, mortality), especially given the high prevalence of polypharmacy in the elderly. Polypharmacy is the simultaneous use of multiple drugs by a single patient, for one or more conditions, which increases the risk of adverse events. For example, a study by MedPAC found that some beneficiaries E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59980 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations who use opioids fill more than 50 prescriptions among 10 drug classes annually (https://www.medpac.gov/docs/ default-source/reports/chapter-5polypharmacy-and-opioid-use-amongmedicare-part-d-enrollees-june-2015report-.pdf?sfvrsn=0, MedPAC, 2015). As part of a multifaceted response to address the growing problem of overuse and abuse of opioids in the Part D program, CMS adopted a policy in 2013 requiring Medicare Part D plan sponsors to implement enhanced drug utilization review. Between 2011 through 2014, there was a 26 percent decrease or 7,500 fewer Medicare Part D beneficiaries identified as potential opioid overutilizers which may be due, at least in part, to these new policies. On January 5, 2017, CMS released its Opioid Misuse Strategy. This document outlines CMS’ strategy and the array of actions underway to address the national opioid misuse epidemic and is available at https://www.cms.gov/Outreach-andEducation/Outreach/Partnerships/ Downloads/CMS-Opioid-MisuseStrategy-2016.pdf. We aim to align our policies under the Shared Savings Program with the priorities identified in the Opioid Misuse Strategy and the Department of Health and Human Services Strategy to Combat Opioid Abuse, Misuse, and Overdose 36 and to help ACOs and their participating providers and suppliers in responding to and managing opioid use, and are therefore considering several actions to improve alignment. Specifically, as we described in the August 2018 proposed rule, we are considering what information regarding opioid use, including information developed using aggregate Medicare Part D data, could be shared with ACOs. We are also considering the addition of one or more measures specific to opioid use to the ACO quality measures set. The potential benefits of such policies would be to focus ACOs on the appropriate use of opioids for their assigned beneficiaries and support their opioid misuse prevention efforts. First, we are considering what information, including what aggregated Medicare Part D data, could be useful to ACOs to combat opioid misuse in their assigned beneficiary population. We recognize the importance of available and emerging resources regarding the opioid epidemic at the federal, state, and local level, and intend to work with our federal partners to make relevant resources available in a timely manner to support ACOs’ goals and activities. 36 https://www.hhs.gov/opioids/sites/default/ files/2018-09/opioid-fivepoint-strategy-20180917508compliant.pdf. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 We will also continue to share information with ACOs highlighting Federal opioid initiatives, such as the CDC Guideline for Prescribing Opioids for Chronic Pain (https://www.cdc.gov/ drugoverdose/prescribing/ guideline.html), which reviews the CDC’s recommended approach to opioid prescribing, and the Surgeon General’s report on Substance Use and Addiction, Facing Addiction in America: The Surgeon General’s Report on Alcohol, Drugs, and Health, (https:// addiction.surgeongeneral.gov/) which focuses on educating and mobilizing prescribers to take action to end the opioid epidemic by improving prescribing practices, informing patients about the risks of and resources for opioid addiction, and encouraging health care professionals to take a pledge to end the opioid crisis. We also intend to continue to highlight information about the opioid crisis and innovations for opioid treatment and prevention strategies in ACO communications and webinars by including topics such as innovative uses of health IT for opioid use disorder treatment and specifically for electronic clinical decision support consistent with the CDC guidelines, as available. Although we recognize that not all beneficiaries assigned to Shared Savings Program ACOs have Part D coverage, we believe a sufficient number do have Part D coverage to make aggregate Part D data regarding opioid use helpful for the ACOs. As an example, we have found the following information for performance year 2016: • Approximately 70 percent of beneficiaries assigned to ACOs participating in the Shared Savings Program had continuous Part D coverage. • For assigned beneficiaries with continuous Part D enrollment, almost 37 percent had at least one opioid prescription. This percentage ranged from 10.6 percent to 58.3 percent across ACOs. • The mean number of opioid medications filled per assigned beneficiary (with continuous Part D coverage) varied across ACOs, ranging from 0.3 to 4.5 prescriptions filled, with an average of 2.1 prescriptions filled. • The number of opioid prescriptions filled for each assigned beneficiary with at least one opioid prescription filled varied across ACOs and ranged from 2.6 to 8.4 prescriptions, with an average of 5.5 opioid prescriptions filled. ACOs currently receive, as part of the monthly claims and claims line feed data, Part D prescription drug event (PDE) data on prescribed opioids for their assigned beneficiaries who have PO 00000 Frm 00146 Fmt 4701 Sfmt 4700 not opted out of data sharing. We encourage ACOs to use this beneficiarylevel data in their care delivery practices. In the August 2018 proposed rule (83 FR 41907), we sought suggestions for other types of aggregate data related to opioid use that could be added for informational purposes to the aggregate quarterly and annual reports CMS provides to ACOs. The aim would be for ACOs to utilize this additional information to improve population health management for assigned beneficiaries, including prevention, identifying anomalies, and coordinating care. The type of aggregate data should be highly relevant for a populationbased program at the national level and have demonstrated value in quality improvement initiatives. We noted that we are particularly interested in high impact aggregate data that would reflect gaps in quality of care, patient safety, multiple aspects of care, and drivers of cost. We aim to provide aggregate data that have validity for longitudinal analysis to enable both ACOs and the Shared Savings Program to trend performance across time and monitor for changes. Aggregate data on both processes and outcomes are appropriate, provided that the data are readily available. Types of aggregate data that we have begun to consider, based on the information available from prescription drug event records for assigned beneficiaries enrolled in Medicare Part D, include filled prescriptions for opioids (percentage of the ACO’s assigned beneficiaries with any opioid prescription, number of opioid prescriptions per opioid user), number of beneficiaries with a concurrent prescription of opioids and benzodiazepines; and number of beneficiaries with opioid prescriptions above a certain daily Morphine Equivalent Dosage threshold. We also sought comments on measures that could be added to the quality measure set for the purpose of addressing the opioid epidemic and addiction, more generally. We sought comment on measures related to various aspects of opioid use, such as prevention, pain management, or opioid use disorder treatment, and on measures related to addiction. In particular, we noted that we were considering the following relevant NQF-endorsed measures, with emphasis on Medicare beneficiaries with Part D coverage who are 18 years or older without cancer or enrolled in hospice: • NQF #2940 Use of Opioids at High Dosage in Persons Without Cancer: Analyzes the proportion (XX out of 1,000) of Medicare Part D beneficiaries E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 18 years or older without cancer or enrolled in hospice receiving prescriptions for opioids with a daily dosage of morphine milligram equivalent (MME) greater than 120 mg for 90 consecutive days or longer. • NQF #2950 Use of Opioids from Multiple Providers in Persons Without Cancer: Analyzes the proportion (XX out of 1,000) of Medicare Part D beneficiaries 18 years or older without cancer or enrolled in hospice receiving prescriptions for opioids from four (4) or more prescribers AND four (4) or more pharmacies. • NQF #2951 Use of Opioids from Multiple Providers and at High Dosage in Persons Without Cancer: Analyzes the proportion (XX out of 1,000) of Medicare Part D beneficiaries 18 years or older without cancer or enrolled in hospice with a daily dosage of morphine milligram equivalent (MME) greater than 120 mg for 90 consecutive days or longer, AND who received opioid prescriptions from four (4) or more prescribers AND four (4) or more pharmacies. In addition, we sought input on potential measures for which data are readily available, such as measures that might be appropriately calculated using Part D data, and that capture performance on outcomes of appropriate opioid management. We requested that comments on measures that are not already NQF endorsed include descriptions of reliability, validity, benchmarking, the population in which the measure was tested, along with the data source that was used, and information on whether the measure is endorsed and by what organization. We recognized that measures of the various aspects of opioid use may involve concepts related to integrated, coordinated, and collaborative care, including as applicable for co-occurring and/or chronic conditions, as well as measures that reflect the impact of interventions on patient outcomes, including direct and indirect patient outcome measures. We also sought comment on opioid-related measures that would support effective measurement alignment of substance use disorders across programs, settings, and varying interventions. Comment: A majority of commenters supported CMS’ focus on burden reduction stating that they are encouraged by the administration’s efforts to reduce reporting burden for healthcare providers. However, one commenter cautioned that although decreasing burden is a laudable goal, removing process measures could unfairly impact the quality scores of healthcare providers who care for VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 vulnerable patients exposed to the harshest social determinants of health. Several commenters suggested that CMS strive toward a core measure set that identifies and harmonizes measures across multiple CMS programs, so that incentives and goals are aligned across healthcare providers and care settings. Several commenters supported the agency’s Meaningful Measures Initiative stating that CMS should not only consider whether a measure is a process measure, but also whether the measure is considered a low-value process measure, before removing it from the Shared Savings Program quality measure set. In addition, these commenters supported CMS’ move toward the use of outcome measures, as the emphasis on improved health outcomes is an appropriate focus and goal. Several commenters suggested future potential refinements to the Shared Savings Program measure set. One commenter urged CMS to better align the Shared Savings Program with Medicare Advantage, suggesting that there should be fewer measures that are included in a roadmap for implementation in both programs, because the different measures and the differing standards for compliance that are currently used cause confusion and require the use of limited provider and staff resources. In addition, this commenter stated that with a roadmap of measures, organizations would be able to focus their energies on achieving these metrics in a systematic and deliberate fashion. Another commenter expressed concern with the timing and burden of quality measurement and payment, suggesting that we streamline quality efforts to include ten specific outcome measures that have a social and public health impact and offering a financial incentive in connection with each measure to encourage physicians to drive, fund, and sustain continued quality efforts. A few commenters suggested that CMS should focus on the prevention, treatment, and management of behavioral health. They stated that in the absence of effective behavioral health assessment tools, the vast majority of people with mental health conditions go unidentified in primary care settings, which in most cases leads to non-adherent patients and higher total medical costs. In addition, they stated that behavioral health is central to the prevention, treatment, and management of the preventable manifestations of diseases and health conditions. They suggested that CMS consider including broader measures PO 00000 Frm 00147 Fmt 4701 Sfmt 4700 59981 that would encourage behavioral health and medical providers to work collaboratively to provide coordinated care. Several commenters suggested that CMS consider developing a quality measure set that would evaluate the breadth of chronic conditions common in the patient population assigned to Shared Savings Program ACOs and use appropriate outcome measures to ensure assigned beneficiaries are receiving the necessary care. They noted that the proposed Shared Savings Program quality measure set discussed in section III.F.1.c. of the CY 2019 PFS proposed rule (83 FR 35876 through 35878) does not include measures related to respiratory conditions, like chronic obstructive pulmonary disease or asthma, diabetes, or additional conditions like heart failure. They encouraged CMS to include measures that evaluate the quality of care for these conditions, such as, measures focused on the delivery of comprehensive lower extremity exams for diabetic patients, and rates of complications such as amputation. They stated that greater emphasis on management of chronic conditions is necessary to promote quality and improve patient outcomes. Another commenter suggested CMS should increase the number of claimsbased measures in the Shared Savings Program measure set and provide ACOs with user-friendly, actionable reports that detail the ACO-specific data used to calculate specific measure performance. One commenter suggested that CMS consider quality measures that reinforce shared decision making, as part of treatment plans that align with the individual’s goals as this is a foundational component of high-quality patient-centered care. Response: We thank the commenters for their thoughtful input on the quality measures used to assess the performance of ACOs under the Shared Savings Program. As we plan for future updates and changes to the Shared Savings Program quality measure set, we will consider this feedback in the development of our proposals. Comment: The majority of commenters that addressed the potential inclusion of measures related to opioid use in the Shared Savings Program quality measure set were supportive of this effort. A few commenters noted that continued support and recognition for integration of EHRs and electronic sharing of health information, would promote improved communication between healthcare providers, which may help curb opioid abuse and addiction. E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59982 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations Several commenters supported CMS’ efforts to consider the possible addition of opioid use measures to the Shared Savings Program quality measure set in future program years, but some commenters recommended that CMS work with the measure developer and NQF to reduce the dosage threshold of two of the measures discussed in the August 2018 proposed rule to 90 MME per day to align with the CDC guidelines for Prescribing Opioids for Chronic Pain. Another commenter agreed that promoting the measurement of opioid use and overuse, monitoring, and education through quality reporting is an important step in understanding and addressing the opioid crisis. A few commenters recommended that CMS utilize the Prescription Drug Monitoring Program (PDMP) Query measure, as most states have implemented PDMPs, and the PDMP Query measure is a reasonable step to improve and measure quality in opioid prescribing. Another commenter stated that in general they support CMS’ considering the addition of opioid use measures to the Shared Savings Program measure set; however, they expressed their belief that opioid dosage measures are of lowvalue to the program because, ‘‘. . . since the issuance of Centers for Disease Control (CDC) and Prevention guidelines, there have been many reports of patients who have been successfully managed on opioid analgesics for long periods of time.’’ This commenter noted that implementing a quality measure that could force a health provider to abruptly reduce or discontinue this medication regimen could have extreme adverse outcomes such as depression, loss of function, or even suicide. The commenter suggested CMS consider quality measures other than dosage measures when determining the most appropriate metrics to help address and respond to the opioid crisis. One commenter expressed concern with the specific opioid related measures on which CMS sought comment for potential inclusion in the Shared Savings Program quality measure set. The commenter stated that quality measurement needs to focus on utilization of preventive strategies, such as screening and treatment for substance abuse, as well as pain management. This commenter disagreed with the potential inclusion of NQF #2940: Use of Opioids at Higher Dosage in Persons Without Cancer because a measure that focuses only on daily dose and duration of therapy involving prescription opioid analgesics, on its own is not a good indication of quality patient care. In addition, they expressed concerns with VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 the potential inclusion of NQF #2950: Use of Opioids from Multiple Providers in Persons Without Cancer and NQF #2951: Use of Opioids from Multiple Providers and at High Dosage in Persons Without Cancer in the Shared Savings Program measure set, as these measures were developed with the intention of determining the quality of care provided by prescription drug health plans and because of the lack of information on the feasibility of ACOs’ collecting and reporting pharmacy claims data. Another commenter noted that the three opioid measures CMS suggested for inclusion in the Shared Savings Program measure set are appropriately focused on the right patient population and address the major risks associated with opioid misuse—high dosages and multiple prescriptions. However, the commenter urged CMS to conduct testing to ensure the measures provide accurate, reliable data at the ACO level, as they are currently endorsed at the health plan level not the ACO level. The commenter suggested that the measures should be reported on a voluntary or pay-for-reporting basis rather than as pay-for-performance measures for the first few years after they are added to the measure set. Another commenter expressed concern that including measures that are so specific will distract ACOs from focusing on what works for them and their assigned beneficiary population. As an alternative, the commenter suggested CMS provide webinars, education, tools, and data for ACOs to incorporate into their current structure for care management and patient engagement. Several commenters recommended that CMS provide aggregated data to ACOs on opioid use, but they also urged CMS to go further and provide aggregated beneficiary data on the use of all prescribed medications and their related diagnoses. Similarly, another commenter encouraged CMS to continue to add more real-time data to the quarterly quality reports so providers can leverage this data to improve patient care, address social inequities in health, correct inefficiencies to drive down costs, and help to address the nation’s opioid epidemic and other pressing health crises. Response: We thank the commenters for their thoughtful input on the possible addition of measures related to opioid use to the quality measure set for the Shared Savings Program. As we plan for future updates and changes to the Shared Savings Program quality measure set, we will consider this feedback from commenters before PO 00000 Frm 00148 Fmt 4701 Sfmt 4700 making any proposals with respect to the addition of opioid use measures. f. Promoting Interoperability Consistent with the call in the 21st Century Cures Act for interoperable access, exchange, and use of health information, the final rule entitled, 2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications (2015 Edition final rule) (80 FR 62601) under 45 CFR part 170 37 focused on health IT certification criteria that support patient care, patient participation in care delivery, and electronic exchange of interoperable health information. The 2015 Edition final rule, which was issued on October 16, 2015, aimed to improve interoperability by adopting new and updated vocabulary and content standards for the structured recording and exchange of health information and to facilitate the accessibility and exchange of data by including enhanced data export, transitions of care, and application programming interface capabilities. These policies are relevant to assessing the use of CEHRT under the Quality Payment Program, Shared Savings Program, and other value based payment initiatives. Under the Shared Savings Program, section 1899(b)(2)(G) of the Act requires participating ACOs to define processes to report on quality measures and coordinate care, such as through the use of telehealth, remote patient monitoring, and other such enabling technologies. Consistent with the statute, ACOs participating in the Shared Savings Program are required to coordinate care across and among primary care physicians, specialists, and acute and post-acute providers and suppliers and to have a written plan to encourage and promote the use of enabling technologies for improving care coordination, including the use of electronic health records and electronic exchange of health information (§ 425.112(b)(4)). Additionally, since the inception of the program in 2012, CMS has assessed the level of CEHRT use by certain clinicians in the ACO using a double-weighted quality measure (Use of Certified EHR Technology, ACO–11) as part of the quality reporting requirements for each performance year. Based on previously-finalized policies, for the 2018 performance year, we will use data derived from the Quality 37 For more information, see https:// www.healthit.gov/sites/default/files/understandingcertified-health-it-2.pdf. E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations Payment Program’s Promoting Interoperability performance category to calculate the percentage of eligible clinicians participating in an ACO who successfully meet the Advancing Care Information Performance Category Base Score for purposes of ACO–11. Because the measure is used in determining an ACO’s quality score and for determining shared savings or shared losses under the Shared Savings Program, all eligible clinicians participating in Shared Savings Program ACOs must submit data for the Quality Payment Program’s Advancing Care Information performance category for performance year 2018, including those eligible clinicians who are participating in Shared Savings Program tracks that have been designated as Advanced APMs and who have met the QP threshold or are otherwise not subject to the MIPS reporting requirements. In the August 2018 proposed rule (83 FR 41908), we noted that some alternative payment models tested by the Innovation Center, require all participants to use CEHRT even though certain tracks within those Models do not meet the financial risk standard for designation as Advanced APMs. The primary rationale for this requirement is to promote CEHRT use by eligible clinicians and organizations participating in APMs by requiring them to demonstrate a strong commitment to the exchange of health information, regardless of whether they are participating in an APM that meets the criteria to be designated as an Advanced APM. Under the Quality Payment Program, an incentive payment will be made to certain Qualifying APM Participants (QPs) participating in Advanced APMs. Beginning in 2017, an eligible clinician can become a QP for the year by participating sufficiently in an Advanced APM during the QP performance period. Eligible clinicians who are QPs for a year receive a lump sum APM incentive payment for payment years from 2019 through 2024, and are excluded from the MIPS reporting requirements for the performance year and the MIPS payment adjustment for the payment year. In the CY 2017 Quality Payment Program final rule (81 FR 77408), we finalized the criteria that define an Advanced APM based on the requirements set forth in sections 1833(z)(3)(C) and (D) of the Act. An Advanced APM is an APM that, among other criteria, requires its participants to use CEHRT. In the CY 2017 Quality Payment Program final rule, we established that Advanced APMs meet this requirement if the APM either—(1) VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 requires at least 50 percent of eligible clinicians in each participating APM Entity, or for APMs in which hospitals are the APM Entities, each hospital, to use CEHRT to document and communicate clinical care to their patients or other health care providers; or (2) for the Shared Savings Program, applies a penalty or reward to an APM Entity based on the degree of the use of CEHRT of the eligible clinicians in the APM Entity (§ 414.1415(a)(1)(i) and (ii)). In the CY 2017 PFS final rule, we updated the title and specifications of the EHR quality measure (ACO–11) to align with the Quality Payment Program criterion on CEHRT use in order to ensure that certain tracks under the Shared Savings Program could meet the criteria to be Advanced APMs. Specifically, we revised the ACO–11 measure to assess ACOs on the degree of CEHRT use by all eligible clinicians participating in the ACO. Performance on the measure is determined by calculating the percentage of eligible clinicians participating in the ACO who successfully meet the Promoting Interoperability Performance Category Base Score. In light of our additional experience with the Shared Savings Program, our desire to continue to promote and encourage CEHRT use by ACOs and their ACO participants and ACO providers/suppliers, and our desire to better align with the goals of the Quality Payment Program and the criteria for participation in certain alternative payment models tested by the Innovation Center, in the August 2018 proposed rule, we indicated that we believe it would be appropriate to amend our regulations related to CEHRT use and the eligibility requirements for ACOs to participate in the Shared Savings Program. Specifically, we proposed to add a requirement that all ACOs demonstrate a specified level of CEHRT use in order to be eligible to participate in the Shared Savings Program. Additionally, we proposed that, as a condition of participation in a track, or a payment model within a track, that meets the financial risk standard to be an Advanced APM, ACOs must certify that the percentage of eligible clinicians participating in the ACO who use CEHRT to document and communicate clinical care to their patients or other health care providers meets or exceeds the threshold required for Advanced APMs as defined under the Quality Payment Program (§ 414.1415(a)(1)(i)). In conjunction with this proposed new eligibility requirement, we proposed to retire the EHR quality measure (ACO–11) related PO 00000 Frm 00149 Fmt 4701 Sfmt 4700 59983 to CEHRT use, thereby reducing reporting burden, effective for quality reporting for performance years starting on January 1, 2019, and subsequent performance years. In addition, consistent with our proposal to align with the Advanced APM criterion on use of CEHRT, we proposed to apply the definition of CEHRT under the Quality Payment Program (§ 414.1305), including any subsequent updates to this definition, for purposes of the Shared Savings Program by adding a definition of ‘‘CEHRT’’ to § 425.20. First, we proposed that for performance years starting on January 1, 2019, and subsequent performance years, ACOs in a track or a payment model within a track that does not meet the financial risk standard to be an Advanced APM would have to attest and certify upon application to participate in the Shared Savings Program, and subsequently, as part of the annual certification process, that at least 50 percent of the eligible clinicians participating in the ACO use CEHRT to document and communicate clinical care to their patients or other health care providers. ACOs would be required to submit this certification in the form and manner specified by CMS. We stated that our proposed requirement aligned with the requirements regarding CEHRT use in many alternative payment models being tested by the Innovation Center. Additionally, we noted that at the time of application, ACOs must have a written plan to use enabling technologies, such as electronic health records and other health IT tools, to coordinate care (§ 425.112(b)(4)(i)(C)). Over the years, successful ACOs have impressed upon us the importance of ‘‘hitting the ground running’’ on the first day of their participation in the Shared Savings Program, rather than spending the first year or two developing their care processes. We stated our belief that requiring ACOs that are entering a track or a payment model within a track that does not meet the financial risk standard to be an Advanced APM to certify that at least 50 percent of the eligible clinicians participating in the ACO use CEHRT would align with existing requirements under the Shared Saving Program and many Innovation Center alternative payment models and encourage participation by organizations that are more likely to meet the program goals. In addition, we stated that such a requirement would also promote greater emphasis on the importance of CEHRT use for care coordination. Finally, we noted that in the CY 2019 PFS proposed rule, we had proposed to increase the threshold of E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59984 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations CEHRT use required for APMs to meet criteria for designation as Advanced APMs under the Quality Payment Program to 75 percent (see 83 FR 35990). Given our proposed updates and modifications to the Shared Savings Program tracks in the August 2018 proposed rule, as well as the proposed changes to the requirements regarding CEHRT use under the Quality Payment Program, we explained that we believe it is important that only those ACOs that are likely to be able to meet or exceed the threshold designated for Advanced APMs should be eligible to enter and continue their participation in the Shared Savings Program. Because of this, and also our desire to align requirements across the different payment models and tracks in Shared Savings Program, as explained in more detail later in this section, we also considered whether to propose to require all Shared Savings Program ACOs, including ACOs in tracks or payment models within tracks that would not meet the financial criteria to be designated as Advanced APMs, to meet the 75 percent threshold proposed under the Quality Payment Program. We proposed changes to the regulations at § 425.204(c) (to establish the new application requirement) and § 425.302(a)(3)(iii) (to establish the new annual certification requirement). We also proposed to add a new provision at § 425.506(f)(1) to indicate that for performance years starting on January 1, 2019, and subsequent performance years, all ACOs in a track or a payment model within a track that does not meet the financial risk standard to be an Advanced APM must certify that at least 50 percent of their eligible clinicians use CEHRT to document and communicate clinical care to their patients or other health care providers. We noted that this proposal, if finalized, would not affect the previouslyfinalized requirements for MIPS eligible clinicians reporting on the Promoting Interoperability (PI) performance category under MIPS. In other words, MIPS eligible clinicians who are participating in ACOs would continue to report as usual on the Promoting Interoperability performance category. We welcomed comment on these proposed changes. We also sought comment on whether the percentage of CEHRT use should be set at a level higher than 50 percent for ACOs in a track or a payment model within a track that does not meet the financial risk standard to be an Advanced APM given that average ACO performance on the Use of Certified EHR Technology measure (ACO–11) has substantially VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 exceeded 50 percent, with ACOs reporting that on average roughly 80 percent of primary care physicians in their ACOs meet meaningful use requirements,38 suggesting that a higher threshold may be warranted now or in the future. We noted that a higher threshold percentage (such as 75 percent) would align with the proposed changes to the CEHRT use requirement under the Quality Payment Program that were included in the CY 2019 PFS proposed rule. Further, for ACOs in tracks or models that meet the financial risk standard to be Advanced APMs under the Quality Payment Program, we proposed to align the proposed CEHRT use threshold with the criterion on use of CEHRT established for Advanced APMs under the Quality Payment Program. We noted that, although it would be ideal for all ACOs to meet the same CEHRT thresholds to be eligible for participation in the Shared Savings Program, there may be reasons why it may be desirable for ACOs in tracks or payment models within a track that do not meet the financial risk standard for Advanced APMs to have a different threshold requirement for CEHRT use than more sophisticated ACOs that are participating in tracks or payment models that qualify as Advanced APMs under the Quality Payment Program. For example, we noted that in order for an APM to meet the criteria to be an Advanced APM under the Quality Payment Program, it must currently require at least 50 percent of eligible clinicians in each participating APM entity to use CEHRT to document and communicate clinical care to their patients or other health care providers (in addition to certain other criteria). However, as previously noted, in the CY 2019 PFS proposed rule, we proposed to increase this threshold level under the Quality Payment Program to 75 percent of eligible clinicians in each participating Advanced APM entity. Therefore, for performance years starting on January 1, 2019, and subsequent performance years for Shared Savings Program tracks (or payment models within tracks) that meet the financial risk standard to be an Advanced APM, we proposed to align the CEHRT requirement with the Quality Payment Program Advanced APM CEHRT use criterion at § 414.1415(a)(1)(i). Specifically, we proposed that such ACOs would be 38 This estimate is based on calculations of primary care physician CEHRT use prior to the changes made to ACO–11 to align with the Quality Payment Program, which became effective for quality reporting for performance year 2017. PO 00000 Frm 00150 Fmt 4701 Sfmt 4700 required to certify that they meet the higher of the 50 percent threshold proposed for ACOs in a track (or a payment model within a track) that does not meet the financial risk standard to be an Advanced APM or the CEHRT use criterion for Advanced APMs under the Quality Payment Program at § 414.1415(a)(1)(i). We stated that requiring these ACOs to meet the higher of the 50 percent threshold proposed for ACOs in a track (or a payment model within a track) that does not meet the financial risk standard to be an Advanced APM or the CEHRT use criterion for Advanced APMs would ensure alignment of eligibility requirements across all Shared Savings Program ACOs, while also ensuring that if the CEHRT use criterion for Advanced APMs were higher than 50 percent, those Shared Savings Program tracks (or payment models within a track) that meet the financial risk standard to be an Advanced APM would also meet the CEHRT threshold established under the Quality Payment Program. We anticipated that for performance years starting on January 1, 2019, the tracks (or payment models within tracks) that would be required to meet the CEHRT threshold designated at § 414.1415(a)(1)(i) would include Track 2, Track 3, and the Track 1+ Model, and for performance years starting on July 1, 2019, would include the proposed BASIC track, Level E, and the proposed ENHANCED track. ACOs in these tracks (or a payment model within such a track) would be required to attest and certify that the percentage of the eligible clinicians in the ACO that use CEHRT to document and communicate clinical care to their patients or other health care providers meets or exceeds the level of CEHRT use specified under the Quality Payment Program regulation at § 414.1415(a)(1)(i). We noted that although this proposal might cause Shared Savings Program ACOs in different tracks (or different payment models within the same track) to be held to different requirements regarding CEHRT use, we believed it would be appropriate to ensure not only that ACOs that are still new to participation in the Shared Savings Program would not be excluded from the program due to a requirement that a high percentage of eligible clinicians participating in the ACO use CEHRT, but also that eligible clinicians in ACOs further along the risk continuum would have the opportunity to participate in an Advanced APM for purposes of the Quality Payment Program. We proposed to add a new provision to the regulations at § 425.506(f)(2) to E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations establish the CEHRT requirement for performance years starting on January 1, 2019, and subsequent performance years for ACOs in a track or a payment model within a track that meets the financial risk standard to be an Advanced APM under the Quality Payment Program. These ACOs would be required to certify that the percentage of eligible clinicians participating in the ACO that use CEHRT to document and communicate clinical care to their patients or other health care providers meets or exceeds the higher of 50 percent or the threshold for CEHRT use by Advanced APMs at § 414.1415(a)(1)(i). We sought comment on this proposal. We also sought comment on whether we should apply the same standard regarding CEHRT use across all Shared Savings Program ACOs, including ACOs participating in tracks or payment models within tracks that do not meet the financial risk standard to be designated as Advanced APMs, specifically Track 1 and the proposed BASIC track, Levels A through D, or maintain the proposed 50 percent requirement for these ACOs as they gain experience on the glide path to performance-based risk. We stated that, as a part of these proposals to require ACOs to certify that a specified percentage of their eligible clinicians use CEHRT, CMS would reserve the right to monitor, assess, and/ or audit an ACO’s compliance with respect to its certification of CEHRT use among its participating eligible clinicians, consistent with §§ 425.314 and 425.316, and to take compliance actions (including warning letters, corrective action plans, and termination) as set forth at §§ 425.216 and 425.218 when ACOs fail to meet or exceed the required CEHRT use thresholds. Additionally, we proposed to adopt for purposes of the Shared Savings Program the same definition of ‘‘CEHRT’’ as is used under the Quality Payment Program. We proposed to amend § 425.20 to incorporate a definition of CEHRT consistent with the definition at § 414.1305, including any subsequent updates or revisions to that definition. Consistent with this proposal and to ensure alignment with the requirements regarding CEHRT use under the Quality Payment Program, we also proposed to amend § 425.20 to incorporate the definition of ‘‘eligible clinician’’ at § 414.1305 that applies under the Quality Payment Program. Additionally, we stated that if the proposal to introduce a specified threshold of CEHRT use as an eligibility requirement for participation in the Shared Savings Program is finalized, we believed this new requirement should VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 replace the current ACO quality measure that assesses the Use of Certified EHR Technology (ACO–11). We explained that the proposed new eligibility requirement, which would be assessed through the application process and annual certification, would help to meet the goals of the program and align with the approach used in other MIPS APMs. Moreover, the proposed new requirement would render reporting on the Use of Certified EHR Technology quality measure unnecessary in order for otherwise eligible tracks (and payment models within tracks) to meet the Advanced APM criterion regarding required use of CEHRT under § 414.1415(a)(1)(i). As a result, continuing to require ACOs to report on this measure would impose undue reporting burden on eligible clinicians that meet the QP threshold and would otherwise not be required to report the Promoting Interoperability performance category for purposes of the Quality Payment Program. Therefore, we proposed to remove the Use of Certified EHR Technology measure (ACO–11) from the Shared Savings Program quality measure set, effective with quality reporting for performance years starting on January 1, 2019, and subsequent performance years. We proposed corresponding changes to the regulation at § 425.506. We also reiterated that the removal of the Use of Certified EHR Technology measure (ACO–11) from the quality measure set used under the Shared Savings Program, if finalized, would not affect policies under MIPS for reporting on the Promoting Interoperability performance category and scoring under the APM Scoring Standard for MIPS eligible clinicians in MIPS APMs. In other words, eligible clinicians subject to MIPS (such as eligible clinicians in the proposed BASIC track, Levels A through D, Track 1, and other MIPS eligible clinicians who are required to report on the Promoting Interoperability performance category for purposes of the Quality Payment Program) would continue to report as usual on the Promoting Interoperability performance category. However, data reported for purposes of the Promoting Interoperability performance category under MIPS would not be used to assess the ACO’s quality performance under the Shared Savings Program. We welcomed public comment on the proposal to remove the quality measure on Use of Certified EHR Technology (ACO–11) from the Medicare Shared Savings Program measure set, effective for quality reporting for performance PO 00000 Frm 00151 Fmt 4701 Sfmt 4700 59985 years starting on January 1, 2019, and subsequent performance years. Finally, as discussed previously in this section, in the CY 2017 Quality Payment Program final rule, CMS finalized a separate Advanced APM CEHRT use criterion that applies for the Shared Savings Program at § 414.1415(a)(1)(ii). To meet the Advanced APM CEHRT use criterion under the Shared Savings Program, a penalty or reward must be applied to an APM Entity based upon the degree of CEHRT use among its eligible clinicians. We believed that this alternative criterion was appropriate to assess the Advanced APM CEHRT use requirement under the Shared Savings Program because, at the time, a specific level of CEHRT use was not required for participation in the program (81 FR 77412). As we explained in the August 2018 proposed rule (83 FR 41911), our proposal to impose specific CEHRT use requirements on ACOs participating in the Shared Savings Program would eliminate the need for the separate CEHRT use criterion applicable to the Shared Savings Program APMs found at § 414.1415(a)(1)(ii). We noted that if the proposal to incorporate specific requirements regarding the use of CEHRT by Shared Savings Program ACOs were finalized, ACOs seeking to participate in a Shared Savings Program track (or payment model within a track) that meets the financial risk standard to be an Advanced APM would be required to demonstrate that the percentage of eligible clinicians in the ACO using CEHRT to document and communicate clinical care to their patients or other health care providers meets or exceeds the higher of 50 percent or the percentage specified in the CEHRT use criterion for Advanced APMs at § 414.1415(a)(1)(i). As a result, a separate CEHRT use criterion for APMs under the Shared Savings Program would no longer be necessary. Therefore, we proposed to revise the separate Shared Savings Program CEHRT use criterion at § 414.1415(a)(1)(ii) so that it would apply only for QP Performance Periods under the Quality Payment Program prior to 2019. We sought comment on this proposal. Comment: Several commenters supported the continued recognition for integration of Electronic Medical Records (EMRs) and the sharing of health information between providers and suppliers. Response: We thank the commenters for their support. Comment: A majority of commenters supported our proposal to replace ACO– E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59986 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 11—Use of Certified EHR Technology with a requirement that ACOs certify regarding the percentage of eligible clinicians participating in the ACO that use CEHRT to document and communicate clinical care to their patients or other health care providers. In addition, many commenters urged CMS to clarify that MIPS eligible clinician participating in Shared Savings Program ACOs would not be required to report Promoting Interoperability (PI) and would instead see PI performance category weights redistributed equally to the Quality and Improvement Activities performance categories. Response: As noted in the August 2018 proposed rule (83 FR 41909), the proposal to replace ACO–11: Use of Certified EHR Technology with a requirement that ACOs certify regarding the level of CEHRT use by eligible clinicians in the ACO would not affect any previously finalized requirements for MIPS eligible clinicians reporting on the PI performance category under MIPS. MIPS eligible clinicians who are participating in ACO tracks that are not Advanced APMs and/or who are not QPs would continue to report as usual on the PI performance category. Comment: Several commenters asked CMS to clarify the proposals for Promoting Interoperability in the August 2018 proposed rule, in the final rule. Specifically, the commenters requested clarification on when complete implementation of the 2015 CEHRT edition was required for ACOs participating in the Shared Savings Program, as the proposal discussed in the August 2018 proposed rule would require an ACO to attest to the percentage of eligible clinicians utilizing CEHRT at the time of application and annually thereafter. The commenters stated that a requirement that they attest to meeting the CEHRT use threshold at the time of application would negatively impact ACOs whose participants make CEHRT decisions (such as upgrades) based on a minimum consecutive 90-day reporting period as set forth by the Quality Payment Program The commenters stated that clarification of the deadline for implementation was needed so healthcare organizations could have a clear understanding of the expectations, allowing them to plan accordingly, especially for those organizations that participate in more than one regulatory program. In addition, several commenters requested that CMS clarify its operational expectations with respect to the proposed new certification requirement, so that ACOs can confirm that they are able to confidently certify VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 with respect to the level of CEHRT use in their ACO. Response: We understand that ACOs need to know the deadline by which they must meet the proposed new requirements regarding the use of CEHRT and have an understanding of how they would be required to demonstrate that they have met the requirement. As we explained in the August 2018 proposed rule, we believe it is appropriate to ensure that ACOs new to participation in the Shared Savings Program not be excluded from the program due to a requirement that a high percentage of eligible clinicians participating in the ACO use CEHRT. At the same time, however, we also sought to align with the CEHRT use requirements under the Quality Payment Program to ensure that eligible clinicians in ACOs further along the risk continuum would have the opportunity to participate in an Advanced APM for purposes of the Quality Payment Program. While our proposal was intended to require that ACOs achieve the applicable CEHRT use threshold starting in the 2019 performance year, we understand from commenters that the requirement that ACOs certify that the percentage of eligible clinicians in the ACO that use CEHRT meets the applicable threshold at time of application could pose an operational challenge. For example, a commenter stated that, ACOs not yet operating on 2015 edition CEHRT may have implementation and cost barriers related to the upgrade of CEHRT that may place them in a non-complaint situation, given the short timeframe between the publication of the final rule and the start of performance year 2019. Based on the comments received in response to the proposals in the August 2018 proposed rule and our desire to align with the Quality Payment Program, under which eligible clinicians must certify regarding their CEHRT use by the last day of the reporting period, we are not finalizing our proposal to require ACOs to certify at the time of application that they meet the applicable CEHRT requirements. However, we are finalizing our proposal to require ACOs to certify annually that the percentage of eligible clinicians participating in the ACO that use CEHRT to document and communicate clinical care to their patients or other health care providers meets or exceeds the applicable percentage during the current performance year. ACOs will be required to submit this certification in the form and manner specified by CMS for performance years starting on January 1, 2019, and all subsequent performance years. For performance PO 00000 Frm 00152 Fmt 4701 Sfmt 4700 years starting on January 1, 2019, the annual certification will occur in the spring of 2019 for ACOs extending their participation agreement for 6 months, and in the fall of 2019 for ACOs that have a 12-month performance year during 2019. We believe this final policy is not only responsive to commenters’ concerns regarding the timing of the certification but also enables timely implementation of the requirement starting in 2019. As noted above, a majority of commenters supported our proposal to replace ACO– 11—Use of Certified EHR Technology with a requirement that ACOs certify regarding the percentage of eligible clinicians participating in the ACO that use CEHRT to document and communicate clinical care to their patients or other health care providers starting January 1, 2019. We also note that this new requirement aligns more closely with the requirements regarding CEHRT use imposed under the Next Generation ACO Model, which requires that participating ACOs certify compliance with the CEHRT use requirement in the fall of each performance year. As stated in the August 2018 proposed rule, we currently require that ACOs must have in place at the time of application a written plan to use enabling technologies, such as electronic health records and other health IT tools, to coordinate care (§ 425.112(b)(4)(i)(C)). Because this policy is already in place, we believe that our decision not to finalize the proposal to require ACOs to certify with respect to their use of CEHRT at time of application to the Shared Savings Program will not undermine the policies under the program designated to promote and encourage the use of CEHRT. Although the comments requesting clarification of our CEHRT proposals were not specific regarding the Shared Savings Program track for which they were seeking clarification, in this final rule we are clarifying the CEHRT threshold requirement for ACOs participating in an Advanced APM. Our intent at the time we proposed this policy was to preserve a minimum threshold of 50 percent CEHRT use for all ACOs in the Shared Savings Program, even if the requirement at § 414.1415(a)(1)(i) were revised through future rulemaking to be below 50 percent. However, we now recognize that this proposed ‘‘higher of’’ policy generated undue complexity. In the unlikely event that the requirement for CEHRT use at § 414.1415(a)(1)(i) were to be reduced to below 50 percent in the future, we would have the opportunity E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations to revisit the Shared Savings Program threshold through future rulemaking. Accordingly, we are revising the proposed regulation at § 425.506(f)(2) to remove the reference to the 50 percent threshold and to indicate that ACOs participating in a Shared Savings Program track that meets the financial risk standard to be an Advanced APM, would be required to demonstrate that the percentage of eligible clinicians in the ACO using CEHRT to document and communicate clinical care to their patients or other health care providers meets or exceeds the percentage specified in the CEHRT use criterion for Advanced APMs under § 414.1415(a)(1)(i). Comment: Several commenters suggested modifications to CMS’ proposal to require ACOs to certify that the percentage of eligible clinicians in the ACO using CEHRT meets the applicable threshold. Several commenters suggested that CMS delay the implementation of the certification requirement attestation until performance year 2020 to avoid inadvertently penalizing Track 1 ACOs that may not have sufficient time to meet the new CEHRT requirement. Several other commenters expressed concern that meeting the 50 percent CEHRT threshold would be a hardship for ACOs in Track 1, especially ACOs composed of independent physician practices and rural practices. These commenters recommended that CMS not finalize this this new requirement, but if CMS were to finalize the 50 percent threshold, these commenters believed that CMS should extend exemptions to low-revenue ACOs or those ACOs in which the plurality of eligible clinicians qualify for a hardship exemption from the Promoting Interoperability performance category under the MIPS. Another commenter suggested that CMS require ACOs in a track (or payment model within a track) that meets the financial risk standard to be an Advanced APM to meet the 50 percent CEHRT requirement in the first performance year and then increase to 75 percent in the second performance year. Response: We disagree with the suggestions that we delay implementation of the proposed new CEHRT use requirement or impose differential requirements for ACOs, depending on their performance year or other attributes. Since the inception of the Shared Savings Program in 2012, we have assessed the level of CEHRT use by certain clinicians in ACOs (ACO–11: Use of Certified EHR Technology) as part of the quality reporting requirements for each performance year. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 In the CY 2017 PFS final rule, we revised the ACO–11 measure to assess ACOs on the degree of CEHRT use by eligible clinicians participating in the ACO in order to align with the Quality Payment Program. Starting in 2017, performance on this measure has been determined by calculating the percentage of eligible clinicians participating in the ACO who successfully meet the Promoting Interoperability Category Base Score. We believe that this experience offers a foundation on which ACOs can build and create processes that allow them to determine the percentage of eligible clinicians participating in the ACO that use CEHRT during an applicable performance year. As noted in the August 2018 proposed rule (83 FR 41909 through 41910), average ACO performance on ACO–11: Use of Certified EHR Technology has substantially exceeded 50 percent, with ACOs reporting that on average roughly 80 percent of primary care physicians in their ACOs meet meaningful use requirements.39 As a result, we do not believe it is unreasonable to expect Track 1 ACOs to meet the requirement that 50 percent or more of the eligible clinicians participating in the ACO use CEHRT beginning in the performance year starting on January 1, 2019. Furthermore, as noted above, our proposal to require ACOs to certify that they meet the applicable CEHRT threshold has no impact on the previously-finalized policy that MIPS eligible clinicians participating in ACOs will continue to report on the PI performance category. Under this policy, MIPS-eligible clinicians are required to use the 2015 version of CEHRT for purposes of reporting the promoting interoperability performance category (§ 414.1305). Accordingly, we believe our proposal to require this version to be used by eligible clinicians participating in Shared Savings Program ACOs aligns with existing requirements under the MIPS and does not impose a new requirement on ACOs. Further, we believe our decision not to finalize the requirement that ACOs certify with respect their level of CEHRT use as part of the application process, and to implement the requirement solely through the annual certification during the performance year, will allow additional time for ACOs to update any internal processes as needed in order to meet this requirement during the 39 This estimate is based on calculations of CEHRT use by primary care physicians prior to the changes made to ACO–11 to align with the Quality Payment Program, which became effective for quality reporting for performance year 2017. PO 00000 Frm 00153 Fmt 4701 Sfmt 4700 59987 performance year starting on January 1, 2019. In addition, as noted above, over the years successful ACOs have provided feedback that it is important to ‘‘hit the ground running’’ on their first day of participation in the Shared Savings Program, rather than spending several years developing their care processes. Based on this feedback, as well as commenters who supported the CEHRT proposal, we believe it is important to implement the proposed CEHRT use thresholds starting January 1, 2019. We believe that the use of these thresholds to assess CEHRT use by ACOs participating in the Shared Savings Program aligns with existing requirements under the program and encourages participation by organizations that are more likely to meet the program goals. We received no comments on our proposals to change the regulation at § 425.204(c) to establish the new application requirement and the regulation at § 425.302(a)(3)(iii) to establish the new annual certification requirement. We also received no comments on our proposal to amend § 425.20 to incorporate a definition of ‘‘CEHRT’’ consistent with the definition at § 414.1305, including any subsequent updates or revisions to that definition, and to incorporate the definition of ‘‘eligible clinician’’ at § 414.1305 that applies under the Quality Payment Program. In addition, we received no comments on our proposal to amend the separate Shared Savings Program CEHRT use criterion at § 414.1415(a)(1)(ii) so that it applies only for QP Performance Periods under the Quality Payment Program prior to 2019. Furthermore, we received no comments on our proposal to add a new provision to the regulation at § 425.506 to establish the CEHRT requirement for performance years starting on January 1, 2019, and subsequent performance years for ACOs in a track or payment model within a track that does not meet the financial risk standard to be an Advanced APM and ACOs in a track or payment model within a track that meets the financial risk standard to be an Advanced APM. After considering the comments received, we are finalizing with modification our proposal that for performance years starting on January 1, 2019, and subsequent performance years, ACOs in a track that does not meet the financial risk standard to be an Advanced APM must certify that at least 50 percent of the eligible clinicians participating in the ACO use CEHRT to document and communicate clinical care to their patients or other health care providers. Specifically, we are finalizing E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59988 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations the requirement that ACOs make this certification annually in the form and manner specified by CMS, but, for the reasons discussed above, we are not finalizing the proposal to require ACOs to make this certification at the time of application. Accordingly, for performance years starting on January 1, 2019, and subsequent performance years, ACOs in a track that does not meet the financial risk standard to be an Advanced APM must certify annually that at least 50 percent of the eligible clinicians participating in the ACO use CEHRT to document and communicate clinical care to their patients or other health care providers. We reiterate that this final policy does not affect the previously finalized requirements for MIPS eligible clinicians reporting on the Promoting Interoperability (PI) performance category under MIPS. Accordingly, MIPS eligible clinicians who are participating in ACOs under a payment track that is not an Advanced APM and/or who are not QPs would continue to report as usual on the Promoting Interoperability performance category. Similarly, after considering the comments received, we are also finalizing with modification our proposal with respect to ACOs in Shared Savings Program tracks that meet the financial risk standard to be an Advanced APM. We proposed that these ACOs would be required to certify at the time of application and annually thereafter that they meet the higher of the 50 percent threshold proposed for ACOs in a track that does not meet the financial risk to be an advanced APM or the CEHRT use criterion for Advanced APMs under the Quality Payment Program at § 414.1415(a)(1)(i). For the reasons discussed previously, we not finalizing the requirement that ACOs certify that they meet the higher of the 50 percent threshold or the applicable threshold under the Quality Payment Program. Rather, ACOs will be required to certify only that they meet the applicable threshold established under the Quality Payment Program. In addition, as also discussed, we are not finalizing our proposal that ACOs certify that they meet the CEHRT requirement at the time of application. Accordingly, for performance years starting on January 1, 2019, and subsequent years, ACOs in a track that meets the financial risk standard to be an Advanced APM must certify annually that the percentage of eligible clinicians participating in the ACO that use CEHRT to document and communicate clinical care to their patients or other health care providers meets or exceeds the threshold VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 established under the Quality Payment Program at § 414.1415(a)(1)(i). We are finalizing the proposed new provision at § 425.506(f) with conforming modifications to reflect the policies we are finalizing in this final rule. As part of these modifications, we are omitting the reference to ‘‘a payment model within a track’’ because we are not addressing the proposal to create the BASIC track, with separate payment models at Levels A through E, at this time. We anticipate summarizing and responding to comments received on this proposal and other proposals related to the participation options under the Shared Savings Program in a forthcoming final rule. For the reasons discussed previously in this section, we are not finalizing the proposed changes to the regulation at § 425.204(c) to establish the new application requirement; but, we are finalizing the proposed changes to the regulation at § 425.302(a)(3)(iii) to establish the new annual certification requirement. In addition, we are finalizing our proposed amendments to § 425.20 to incorporate a definition of ‘‘CEHRT’’ consistent with the definition at § 414.1305, including any subsequent updates or revisions to that definition, and to incorporate the definition of ‘‘eligible clinician’’ at § 414.1305 that applies under the Quality Payment Program. We are also finalizing our proposal to amend the separate Shared Savings Program CEHRT use criterion at § 414.1415(a)(1)(ii) so that it applies only for QP Performance Periods under the Quality Payment Program prior to 2019. As noted in the August 2018 proposed rule (83 FR 41910), CMS reserves the right to monitor, assess, and/or audit an ACO’s compliance with respect to its certification of CEHRT use among its participating eligible clinicians, consistent with §§ 425.314 and 425.316, and to take compliance actions (including warning letters, corrective action plans, and termination) as set forth at §§ 425.216 and 425.218 when ACOs fail to meet or exceed the required CEHRT use thresholds. Finally, after considering the comments received in response to the proposal to remove ACO–11: Use of Certified EHR Technology measure from the Shared Savings Program quality measure set, we are finalizing our proposal effective with quality reporting for performance years starting on January 1, 2019, and subsequent performance years. We are also finalizing the corresponding revisions to the regulation at § 425.506 to reflect this change. PO 00000 Frm 00154 Fmt 4701 Sfmt 4700 3. Applicability of Final Policies to Track 1+ Model ACOs a. Background In the August 2018 proposed rule (83 FR 41912), we discussed the applicability of proposed policies to Track 1+ Model ACOs. We explained that the Track 1+ Model was established under the Innovation Center’s authority at section 1115A of the Act, to test innovative payment and service delivery models to reduce program expenditures while preserving or enhancing the quality of care for Medicare, Medicaid, and Children’s Health Insurance Program beneficiaries. We noted that 55 Shared Savings Program Track 1 ACOs entered into the Track 1+ Model beginning on January 1, 2018. This includes 35 ACOs that entered the model within their current agreement period (to complete the remainder of their agreement period under the model) and 20 ACOs that entered into a new 3-year agreement period under the model. To enter the Track 1+ Model, ACOs must be approved to participate in the model and are required to agree to the terms and conditions of the model by executing a Track 1+ Model Participation Agreement available at https://www.cms.gov/Medicare/ Medicare-Fee-for-Service-Payment/ sharedsavingsprogram/Downloads/ track-1plus-model-par-agreement.pdf. Track 1+ Model ACOs are also required to have been approved to participate in the Shared Savings Program (Track 1) and to have executed a Shared Savings Program Participation Agreement. As indicated in the Track 1+ Model Participation Agreement, in accordance with its authority under section 1115A(d)(1) of the Act, CMS has waived certain provisions of law that otherwise would be applicable to ACOs participating in Track 1 of the Shared Savings Program, as necessary for purposes of testing the Track 1+ Model, and established alternative requirements for the ACOs participating in the Track 1+ Model. We explained that, unless stated otherwise in the Track 1+ Model Participation Agreement, the requirements of the Shared Savings Program under 42 CFR part 425 continue to apply. Consistent with § 425.212, Track 1+ Model ACOs are subject to all applicable regulatory changes, including but not limited to changes to the regulatory provisions referenced within the Track 1+ Model Participation Agreement, that become effective during the term of the ACO’s Shared Savings Program Participation Agreement and Track 1+ Model E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations Participation Agreement, unless otherwise specified through rulemaking or amendment to the Track 1+ Model Participation Agreement. We noted that the terms of the Track 1+ Model Participation Agreement permit the parties (CMS and the ACO) to amend the agreement at any time by mutual written agreement. amozie on DSK3GDR082PROD with RULES3 b. Unavailability of Application Cycles for Entry Into the Track 1+ Model in 2019 In the August 2018 proposed rule (83 FR 41912 through 41913), we discussed the unavailability of application cycles for entry into the Track 1+ Model in 2019 and 2020. We explained that an ACO’s opportunity to join the Track 1+ Model aligns with the Shared Savings Program’s application cycle. The original design of the Track 1+ Model included 3 application cycles for ACOs to apply to enter or, if eligible and if applicable, to renew their participation in the Track 1+ Model for an agreement period start date of 2018, 2019, or 2020. The 2018 application cycle is closed, and as discussed elsewhere in the August 2018 proposed rule, 55 ACOs began participating in the Track 1+ Model on January 1, 2018. As discussed in section II.A.7 of the August 2018 proposed rule (83 FR 41847) and section V.B.1.a of this final rule, we are not offering an application cycle for a January 1, 2019 start date for new agreement periods under the Shared Savings Program. Therefore, we similarly are not offering a start date of January 1, 2019, for participation in the Track 1+ Model. We explained that existing Track 1+ Model ACOs would be able to complete the remainder of their current agreement period in the model. Additionally, as discussed in section II.A.7.c.(1) of the August 2018 proposed rule (83 FR 41854 through 41855) and section V.B.1.c.(1) of this final rule, ACOs currently participating in the Track 1+ Model will not have the opportunity to apply to use a SNF 3-day rule waiver starting on January 1, 2019, under our decision to forgo an annual application cycle for a January 1, 2019 start date in the Shared Savings Program. We proposed that, if finalized, the next available application cycle for a SNF 3day rule waiver would occur in advance of a July 1, 2019 start date. We will address proposals related to future application cycles in subsequent rulemaking. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 c. Applicability of Proposed Policies to Track 1+ Model ACOs Through Revised Program Regulations or Revisions to Track 1+ Model Participation Agreements In section II.F of the August 2018 proposed rule (83 FR 41913 through 41914), we provided a comprehensive discussion of the applicability of the proposed policies to Track 1+ Model ACOs to allow these ACOs to better prepare for their future years of participation in the program and the Track 1+ Model. We explained that there are two ways in which the proposed policies would become applicable to Track 1+ Model ACOs: (1) Through revisions to existing regulations that currently apply to Track 1+ Model ACOs; and (2) through revisions to the ACO’s Track 1+ Model Participation Agreement. We sought comment on these considerations, and any other issues that we may not have discussed related to the effect of the proposed policies on ACOs that entered the Track 1+ Model beginning in 2018. We note that these ACOs will complete their participation in the Track 1+ Model by no later than December 31, 2020 (for ACOs that entered the model at the start of a 3-year agreement period), or sooner in the case of ACOs that entered the model at the start of their second or third performance year within their current 3year agreement period. Generally, comments regarding the application of specific proposals to Track 1+ Model ACOs have been addressed as part of the discussion of comments in the relevant section of this final rule. Accordingly, in this section of this final rule, we are not repeating comments related to the applicability of the proposed policies to ACOs participating in the Track 1+ Model. Therefore, unless specified otherwise, the changes to the program’s regulations finalized in this final rule that are applicable to Shared Savings Program ACOs within a current agreement period will apply to ACOs in the Track 1+ Model in the same way that they apply to ACOs in Track 1, so long as the applicable regulation has not been waived under the Track 1+ Model. Similarly, to the extent that certain requirements of the regulations that apply to ACOs under Track 2 or Track 3 have been incorporated for ACOs in the Track 1+ Model under the terms of the Track 1+ Model Participation Agreement, changes to the regulations as finalized in this final rule will also apply to ACOs in the Track 1+ Model in the same way that they apply to ACOs in Track 2 or Track 3. For PO 00000 Frm 00155 Fmt 4701 Sfmt 4700 59989 example, the following policies apply to Track 1+ Model ACOs: • Revisions to voluntary alignment policies (section V.B.2.b. of this final rule), applicable for the performance year beginning on January 1, 2019, and subsequent performance years. • Revisions to the definition of primary care services used in beneficiary assignment (section V.B.2.c. of this final rule), applicable for the performance year beginning on January 1, 2019, and subsequent performance years. • Discontinuation of quality measure ACO–11; requirement to attest as part of the annual certification that a specified percentage of the ACO’s eligible clinicians use CEHRT (section V.B.2.f. of this final rule), applicable for the performance year beginning on January 1, 2019, and subsequent performance years. We will also apply the following policies finalized in this final rule to Track 1+ Model ACOs through an amendment to the Track 1+ Model Participation Agreement executed by CMS and the ACO: • Annual certification that the percentage of eligible clinicians participating in the ACO that use CEHRT to document and communicate clinical care to their patients or other health care providers meets or exceeds the threshold established under § 414.1415(a)(1)(i) (section V.B.2.f. of this final rule). This certification is required to ensure the Track 1+ Model continues to meet the CEHRT criterion to qualify as an Advanced APM for purposes of the Quality Payment Program. • For ACOs that started a first or second Shared Savings Program participation agreement on January 1, 2016, and entered the Track 1+ Model on January 1, 2018, and that elect to extend their Shared Savings Program participation agreement for the 6-month performance year from January 1, 2019 through June 30, 2019 (as described in section V.B.1 of this final rule): ++ As described in section V.B.1.c.(3) of this final rule, the ACO should extend its repayment mechanism so that it remains in effect for 24 months after the end of the agreement period (June 30, 2021). ++ As described in section V.B.1.c.(10) of this final rule, the ACO is eligible for shared savings if the following conditions are met: The ACO completed the 6-month performance year starting on January 1, 2019; the ACO has completed all close-out procedures specified in § 425.221(a) by the deadline specified by CMS (if applicable); and the ACO has satisfied E:\FR\FM\23NOR3.SGM 23NOR3 59990 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations the criteria for sharing in savings for the performance year. ++ We will determine performance for the 6-month performance year from January 1, 2019 through June 30, 2019, according to the approach specified in a new section of the regulations at § 425.609(b), applying the financial methodology for calculating shared losses specified in the ACO’s Track 1+ Model Participation Agreement. ++ We will continue to share aggregate report data with the ACO for the entire CY 2019, consistent with the approach described in section V.B.1.c.(8) of this final rule, and the terms of the ACO’s Track 1+ Model Participation Agreement. • Extreme and uncontrollable circumstances policies for determining shared losses for performance years 2018 and subsequent years, consistent with the policies specified in § 425.610(i) (section V.B.2.d. of this final rule) and, for ACOs that elect to extend their Shared Savings Program participation agreement for the 6-month performance year from January 1, 2019 through June 30, 2019, in § 425.609(d) (section V.B.1.c.(5) of this final rule). VI. Collection of Information Requirements Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. chapter 35), we are required to publish a 30-day notice in the Federal Register and solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget (OMB) for review and approval. We solicited comments in the notice of proposed rulemaking that published in the July 27, 2018 Federal Register (83 FR 35704). For the purpose of transparency, we are republishing the discussion of the information collection requirements along with a reconciliation of the public comments we received. A. Wages To derive average costs, we used data from the U.S. Bureau of Labor Statistics’ May 2017 National Occupational Employment and Wage Estimates for all salary estimates (https://www.bls.gov/ oes/current/oes_nat.htm). In this regard, Table 60 presents the mean hourly wage, the cost of fringe benefits and overhead (calculated at 100 percent of salary), and the adjusted hourly wage. Private Sector Wages: The adjusted hourly wage is used to calculate the labor costs associated with our finalized requirements. TABLE 60—NATIONAL OCCUPATIONAL EMPLOYMENT AND WAGE ESTIMATES Occupation code Occupation title amozie on DSK3GDR082PROD with RULES3 All Occupations (for Individuals’ Wages) ......................................................... Billing and Posting Clerks ................................................................................ Computer Systems Analysts ............................................................................ Family and General Practitioner ...................................................................... Licensed Practical Nurse (LPN) ...................................................................... Medical Assistant ............................................................................................. Medical Secretary ............................................................................................ Physicians ........................................................................................................ Practice Administrator (Medical and Health Services Managers) ................... Registered Nurse ............................................................................................. As indicated, we adjusted our employee hourly wage estimates by a factor of 100 percent. This is necessarily a rough adjustment, both because fringe benefits and overhead costs vary significantly from employer to employer, and because methods of estimating these costs vary widely from study to study. Nonetheless, we believe that doubling the hourly wage to estimate total cost is a reasonably accurate estimation method. Wages for Individuals: For beneficiaries who elect to complete the CAHPS for MIPS survey, we believe that the burden will be addressed under All Occupations (see Table 60) at $24.34/hr since the group of individual respondents varies widely from working and nonworking individuals and by respondent age, location, years of employment, and educational attainment, etc. Unlike our private sector adjustment to the respondent hourly wage, we did not adjust this figure for fringe benefits and overhead since the individuals’ activities will VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 00–0000 43–3021 15–1121 29–1062 29–2061 31–9092 43–6013 29–1060 11–9111 29–1141 occur outside the scope of their employment. B. Information Collection Requirements (ICRs) 1. ICRs Regarding the Clinical Laboratory Fee Schedule (CLFS) (Section III.A. of This Final Rule) Section 1834A of the Act, as established by section 216(a) of the Protecting Access to Medicare Act of 2014 (PAMA), required significant changes to how Medicare pays for clinical diagnostic laboratory test (CDLTs) under the CLFS. The CLFS final rule, titled ‘‘Medicare Clinical Diagnostic Laboratory Tests Payment System Final Rule’’ (CLFS final rule), was published in the Federal Register on June 23, 2016, and implemented section 1834A of the Act. Under that rule (81 FR 41036), ‘‘reporting entities’’ must report to CMS during a ‘‘data reporting period’’ ‘‘applicable information’’ (that is, certain private payor data) collected during a ‘‘data collection period’’ for their component ‘‘applicable laboratories.’’ In general, the PO 00000 Frm 00156 Fmt 4701 Sfmt 4700 Mean hourly wage ($/hr) 24.34 18.49 44.59 100.27 21.98 16.15 17.25 103.22 53.69 35.36 Fringe benefits and overhead costs ($/hr) n/a 18.49 44.59 100.27 21.98 16.15 17.25 103.22 53.69 35.36 Adjusted hourly wage ($/hr) n/a 36.98 89.18 200.54 43.96 32.30 34.50 206.44 107.38 70.72 payment amount for each CDLT on the CLFS furnished beginning January 1, 2018, is based on the applicable information collected during the 6-month data collection period and reported to us during the 3-month data reporting period, and is equal to the weighted median of the private payor rates for the CDLT. An applicable laboratory is defined at § 414.502, in part, as an entity that is a laboratory (as defined under the Clinical Laboratory Improvement Amendments (CLIA) definition at § 493.2) that bills Medicare Part B under its own National Provider Identifier (NPI). In addition, an applicable laboratory is an entity that receives more than 50 percent of its Medicare revenues during a data collection period from the CLFS and/or the PFS. We refer to this component of the applicable laboratory definition as the ‘‘majority of Medicare revenues threshold.’’ The definition of applicable laboratory also includes a ‘‘low expenditure threshold’’ component, which requires an entity to receive at least $12,500 of its Medicare revenues E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations from the CLFS during a data collection period for its CDLTs that are not advanced diagnostic laboratory tests (ADLTs). In determining payment rates under the private payor rate-based CLFS, one of our goals is to obtain as much applicable information as possible from the broadest possible representation of the national laboratory market on which to base CLFS payment amounts, for example, from independent laboratories, hospital outreach laboratories, and physician office laboratories, without imposing undue burden on those entities. We believe it is important to achieve a balance between collecting sufficient data to calculate a weighted median that appropriately reflects the private market rate for a CDLT, and minimizing the reporting burden for entities. In response to stakeholder feedback in the proposed rule (see section III.A.3 of this final rule for a discussion of this feedback) and in the interest of facilitating our goal, we are finalizing the revision to the majority of Medicare revenues threshold component of the definition of applicable laboratory at § 414.502(3) to exclude Medicare Advantage (MA) payments under Medicare Part C from the definition of total Medicare revenues (that is, the denominator of the majority of Medicare threshold equation). Specifically, this revision could allow additional laboratories of all types serving a significant population of beneficiaries enrolled in Medicare Part C to meet the majority of Medicare revenues threshold and potentially qualify as applicable laboratories (provided they meet all other requirements for applicable laboratory status) and report data to us. In addition, in response to stakeholder feedback (see section III.A.4 of this final rule for a discussion of this feedback) in response to the comment solicitation in the proposed rule and in the interest of obtaining as much applicable information as possible, we are finalizing a revision to the definition of applicable laboratory at § 414.502 to include a hospital that bills Medicare on the Form CMS–1450 14x Type of Bill (OMB control number: 0938–0997) and its electronic equivalent. As such, we believe the finalized changes may result in more applicable information being reported, which we will use to set CLFS payment rates. However, with regard to the CLFSrelated requirements and burden, as we noted in the proposed rule, section 1834A(h)(2) of the Act provides that the Paperwork Reduction Act in chapter 35 of title 44 of the U.S.C. shall not apply to information collected under section VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 1834A of the Act (which is the new private payor rate-based CLFS). For a complete discussion of our finalized revisions to the definition of applicable laboratory in § 414.502 related to the majority of Medicare revenues threshold and use of the Form CMS–1450 14X TOB, we refer readers to sections III.A.4.a of this final rule. 2. ICRs Regarding Appropriate Use Criteria (AUC) for Advanced Diagnostic Imaging Services (§ 414.94 and Section III.D. of this final rule) Consultations: In the CY19 PFS proposed rule, we proposed to revise § 414.94(j) to allow the AUC consultation, when not performed personally by the ordering professional, to be performed by auxiliary personnel (as defined in § 410.26(a)(1)) under the direction of, and incident to, the ordering professional’s services. In this final rule, we did not finalize this proposal but, instead, revised the regulation to specify that clinical staff acting under the direction of the ordering professional may perform the AUC consultation. The revised AUC consultation requirements and burden will be submitted to OMB for approval under control number 0938–1345 (CMS–10654). General practitioners make up a large group of practitioners who order applicable imaging services and will be required to consult AUC under this program so we use ‘‘family and general practitioner’’ from the list of BLS occupation titles (see Table 60) to calculate the following cost estimates. While we proposed to modify the consultation requirement to allow auxiliary personnel, working under the direction of the ordering professional, to interact with the CDSM for AUC consultation, in this final rule we changed this estimate from using the ‘‘registered nurse’’ occupation to using the ‘‘medical assistant’’ occupation to calculate our revised cost estimates for our final policy to allow clinical staff acting under the direction of the ordering professional to perform the AUC consultation. To derive the burden associated with the requirements under § 414.94(j), we estimate it will take 2 minutes (0.033 hr) at $70.72/hr for auxiliary personnel in the form of a registered nurse to consult with a qualified CDSM. The Medicare Benefit Policy Manual (Pub. 100–02), Chapter 15, Section 60.2 IOM 100–02, requires that an incidental service performed by the nonphysician practitioner must have followed from a direct, personal, professional service furnished by the physician. Therefore, to estimate the percentage of PO 00000 Frm 00157 Fmt 4701 Sfmt 4700 59991 consultations available to be performed incident to, we analyzed 2014 Medicare Part B claims comparing evaluation and management visits for new (CPT codes 99201, 99202, 99203, 99204, and 99205) relative to established (CPT codes 99211, 99212, 99213, 99214, 99215) patients with place of service codes 11 (physician’s office). We found that approximately 10 percent of all claims incurred were for new patients. Therefore, we also estimate that 90 percent or 38,863,636 of the total consultations (43,181,818 total consultations × 0.90) will be performed by such auxiliary personnel, with the remaining 10 percent (43,181,818 × 0.10) performed by the ordering professional. In this final rule and after review of public comments (see below), we revised § 414.94(j) to allow ordering professionals to delegate the AUC consultation to clinical staff acting under the direction of the ordering professional. To reflect this change, we updated our burden estimates to reflect the final policy and revised our estimates to replace a registered nurse with medical assistant to perform the AUC consultation. In aggregate, we estimate an annual burden of 1,282,500 hours (38,863,636.2 consultations × 0.033 hr/consultation) at a cost of $41,424,750 (1,282,500 hr × $32.30/hr) or $1.07 per consultation performed by clinical staff under the direction of the ordering professional. We will continue to monitor our burden estimates and, if necessary, adjust them for more precision once the program begins. Additionally, the CY 2018 Physician Fee Schedule final rule (82 FR 52976) explicitly discussed and provided a voluntary period for ordering professionals to begin to familiarize themselves with qualified CDSMs. During the current 18-month voluntary participation period, we estimate there may be 10,230,000 consultations based on market research from current applicants for the qualification of their CDSMs for advanced diagnostic imaging services. Based on feedback from CDSMs with experience in AUC consultation, as well as standards recommended by the Office of the National Coordinator (ONC) 40 and the Healthcare Information Management Systems Society (HIMSS),41 we estimate it will take 2 minutes (0.033 hr) at $200.54/hr for a family and general practitioner or 2 minutes at $32.30/hr for a medical assistant to use a qualified CDSM to consult specified applicable 40 https://ecqi.healthit.gov/cds#quicktabs-tabs_ cds3. 41 https://www.himss.org/improving-outcomes-cdspractical-pearls-new-himss-guidebook. E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59992 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations AUC. The inclusion of a medical assistant in this calculation is reflective of our modifications in the final rule as discussed above. As mentioned previously, we estimate that as many as 90-percent of practices could use auxiliary personnel working under the direction of the ordering professional to interact with the CDSM for AUC consultation. Consequently, we estimate a total burden of 337,590 hours (10,230,000 consultations × 0.033 hr) at a cost of $16,583,771 ([337,590 hr × 0.10 × $200.54/hr] + [337,590 hr × 0.90 × $32.30/hr]). Annually, we estimate 112,530 hours (337,590 hr/3 yr) at a cost of $5,527,924 ($16,583,771/3 yr). We are annualizing the one-time burden (by dividing our estimates by OMB’s 3-year approval period) since we do not anticipate any additional burden after the 18-month voluntary participation period ends. Beginning January 1, 2020, we anticipate 43,181,818 responses in the form of consultations based on the aforementioned market research, as well as Medicare claims data for advanced diagnostic imaging services. As noted earlier, we estimate it will take 2 minutes (0.033 hr) at $200.54/hr for a family and general practitioner or 2 minutes at $32.30/hr for a medical assistant to use a qualified CDSM to consult specified applicable AUC. In aggregate, we estimate an annual burden of 1,425,000 hours (43,181,818 consultations × 0.033 hr/consultation) at a cost of $70,001,700 ([0.1 × 1,425,000 hr × $200.54/hr] + [0.9 × 1,425,000 hr × $32.30/hr]). Annual Reporting: Consistent with section 1834(q)(4)(B) of the Act, we finalized at § 414.94(k) the reporting requirement of AUC consultation information and in the CY 2018 PFS final rule (82 FR 52976) we estimated the burden of implementing the onetime voluntary reporting period beginning in July 2018, and will be implementing the mandatory annual reporting requirement beginning January 1, 2020. Specifically, § 414.94(k) requires Medicare claims for advanced diagnostic imaging services, paid for under an applicable payment system (as defined in § 414.94(b)) and ordered on or after January 1, 2020, to include the following information: (1) Which qualified CDSM was consulted by the ordering professional; (2) whether the service ordered would adhere to specified applicable AUC, would not adhere to specified applicable AUC, or whether specified applicable AUC was not applicable to the service ordered; and (3) the NPI of the ordering professional (if different from the furnishing professional). The reporting VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 requirement will not have any impact on any Medicare claim forms because the forms’ currently approved data fields, instructions, and burden are not expected to change. Consequently, there is no need for review by OMB under the authority of the PRA; however, we have assessed the impact and include an analysis to this effect in the regulatory impact section of this final rule. Significant Hardship Exception: We proposed and are finalizing revisions to § 414.94(i)(3) that provide for a significant hardship exception for ordering professionals who experience a significant hardship affecting their consultation of AUC when ordering an advanced diagnostic imaging service. The revisions establish a process whereby all ordering professionals can self-attest that they are experiencing a significant hardship at the time of placing an advanced diagnostic imaging order. Although this is not a certification being used as a substitute for a collection of AUC consultation information because no consultation is required by statute to take place, the significant hardship exception process consists of appending to the order for an applicable imaging service the significant hardship information for inclusion on the Medicare claim in lieu of the AUC consultation information. This imposes no burden beyond providing identifying information and attesting to the applicable information. In this regard, the use of this process is not ‘‘information’’ as defined under 5 CFR 1320.3(h), and therefore, is exempt from requirements of the PRA. Recordkeeping: Section 1834(q)(4)(C) of the Act provides for certain exceptions to the aforementioned AUC consultation requirement; therefore we believe that some claims for advanced diagnostic imaging services will not contain AUC consultation information, such as in the case of an ordering professional with a significant hardship. However, ordering professionals will store documentation supporting the selfattestation of a significant hardship. Storage of this information could involve the use of automated, electronic, or other forms of information technology at the discretion of the ordering professional. We estimate that the average time for office clerical activities associated with this storage of information to be 10 minutes (0.167 hr) at $34.50/hr for a medical secretary to perform 6,699 recordkeeping actions, since consultation will not take place in the year when a hardship is incurred and 2016 data from the Medicare EHR Incentive Program and the first 2019 payment year MIPS eligibility and special status file suggests this estimate PO 00000 Frm 00158 Fmt 4701 Sfmt 4700 of those seeking hardship (OMB control number 0938–1314; CMS–10621). In aggregate we estimate an annual burden of 1,119 hours (6,699 recordkeeping activities × 0.167 hr/activity) at a cost of $38,596 (0.167 hr/activity × 6,699 recordkeeping activities × $34.50/hr). We solicited comments to inform these burden estimates. The following is a summary of the comments we received regarding these burden estimates. Comment: Commenters questioned the assumptions in CMS’s calculations as part of the proposal to modify the AUC consultation requirement to allow auxiliary personnel, working under the direction of the ordering professional, to interact with the CDSM for AUC consultation. These commenters suggested using the ‘‘medical assistant’’ rather than the ‘‘registered nurse’’ occupation to calculate our revised cost estimates. Response: As stated in this rule, we have finalized a change in the consulting requirement at 414.94(j) to allow ordering professionals to delegate the consultation to clinical staff acting under the direction of the ordering professional. In aggregate, we update our proposed estimate of an annual burden of 1,282,500 hours at a cost of $90,698,400 or $2.33 per consultation to an annual burden of 1,282,500 hours (38,863,636.2 consultations × 0.033 hr/ consultation) at a cost of $41,424,750 (1,282,500 hr × $32.30/hr) or $1.07 per consultation using the medical assistant occupation code 31–9092 with mean hourly wage of $16.15 and 100 percent fringe benefits. Comment: A few commenters disagreed that the reporting requirement will not have any impact on any Medicare claim forms. These commenters observed that the electronic claim standard for the institutional provider (837i) does not capture or have a placeholder for reporting the ordering physician’s NPI. Response: We appreciate the opportunity to clarify our analysis and the distinctions between reporting AUC consultation information and standardized communications on Medicare claims forms. The X12N insurance subcommittee develops and maintains standards for healthcare administrative transactions on professional (837p), institutional (837i), and dental (837d) transactions when submitting healthcare claims for a service or encounter. The current mandated version of 837 transactions is 5010TM. While we have not finalized a process for implementing the reporting requirements at § 414.94(k), we clarify that implementation of changes to the E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations claim form transactions would not take place outside of the existing process we described. After considering the comments, we are updating the proposed impact estimate of consultations by ordering professionals. First, we modified our calculation of the effort by a registered nurse to the effort of a 2-minute consultation with a qualified CDSM by a medical assistant (occupation code 31–9092) with mean hourly wage of $16.15 and 100 percent fringe benefits for 90 percent of consultations (1,282,500 hours) to be $41,424,750 (1,282,500 hours × $32.30/hour). Consequently, we have updated our estimated total burden during the voluntary period to 337,590 hours (10,230,000 consultations × 0.033 hr) at a cost of $16,583,771.16 ([337,590 hr × 0.10 × $200.54/hr] + [337,590 hr × 0.90 × $32.30/hr]). Annually, this estimate represents 112,530 hours (337,590 hr/3 yr) at a cost of $5,527,923.72 ($16,583,771.16/3 yr). Additionally, we update our aggregate estimate of annual burden beginning January 1, 2020 of 1,425,000 hours (43,181,818 consultations × 0.033 hr/consultation) at a cost of $70,001,700 ([0.1 × 1,425,000 hr × $200.54/hr] + [0.9 × 1,425,000 hr × $32.30/hr]). amozie on DSK3GDR082PROD with RULES3 3. ICRs Regarding the Medicare Shared Savings Program (Part 425 and Section III.F. of This Final Rule) Section 1899(e) of the Act provides that chapter 35 of title 44 of the U.S. Code, which includes such provisions as the PRA, shall not apply to the Shared Savings Program. 4. ICRs Regarding the Physician SelfReferral Law (42 CFR Part 411 and Section III.G. of This Final Rule) Section 1877 of the Act, also known as the physician self-referral law: (1) Prohibits a physician from making referrals for certain designated health services (DHS) payable by Medicare to an entity with which he or she (or an immediate family member) has a financial relationship (ownership or compensation), unless an exception applies; and (2) prohibits the entity from filing claims with Medicare (or billing another individual, entity, or third party payer) for those referred services. The statute establishes a number of specific exceptions, and grants the Secretary the authority to create regulatory exceptions for financial relationships that pose no risk of program or patient abuse. Additionally, the statute mandates refunding any amount collected under a bill for an item or service furnished under a prohibited referral. Finally, the statute imposes reporting requirements VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 and provides for sanctions, including civil monetary penalty provisions. As discussed in section III.G. of this rule, we are finalizing regulatory updates to implement section 50404 of the Bipartisan Budget Act of 2018 (Pub. L. 115–123, enacted February 9, 2018), which added provisions to section 1877(h)(1) of the Act pertaining to the writing and signature requirements in certain compensation arrangement exceptions to the physician self-referral law’s referral and billing prohibitions. Although we believe that the newly enacted provisions in section 1877(h)(1) of the Act are principally intended merely to codify in statute existing CMS policy and regulations with respect to compliance with the writing and signature requirements, we are finalizing revisions to our regulations at 42 CFR 411.354(e) and 411.353(g) to address any actual or perceived difference between the statutory and regulatory language, to codify in regulation our longstanding policy regarding satisfaction of the writing requirement found in many of the exceptions to the physician self-referral law, and to make the Bipartisan Budget Act of 2018 policies applicable to compensation arrangement exceptions issued using the Secretary’s authority in section 1877(b)(4) of the Act. The burden associated with the writing and signature requirements is the time and effort necessary to prepare written documents and obtain signatures of the parties. Although the writing and signature requirements are subject to the PRA, we believe the associated burden is exempt under 5 CFR 1320.3(b)(2). We believe that the time, effort, and financial resources necessary to comply with the writing and signature requirements will be incurred by persons during the normal course of their activities and in the absence of federal regulation. Specifically, we believe that, for normal business operations purposes, health care providers and suppliers document their financial arrangements with physicians and others in order to identify and be able to enforce the legal obligations of the parties. Therefore, we believe that the writing and signature requirements should be considered usual and customary business practices. We did not receive any public comments regarding our position that the burden associated with these requirements is a usual and customary business practice that is exempt from the PRA. PO 00000 Frm 00159 Fmt 4701 Sfmt 4700 59993 5. The Quality Payment Program (Part 414 and Section III.I. of This Final Rule) Summary: For the PRA, the Quality Payment Program is comprised of a series of ICRs associated with MIPS and Advanced APMs. The MIPS ICRs consist of registration for virtual groups; qualified registry and QCDR selfnomination; CAHPS survey vendor applications; Quality Payment Program Identity Management Application Process; quality performance category data submission by Medicare Part B claims collection type, QCDR and MIPS CQM collection type, eCQM collection type, and CMS web interface submission type; CAHPS for MIPS survey beneficiary participation; group registration for CMS web interface; group registration for CAHPS for MIPS survey; call for quality measures; reweighting applications for Promoting Interoperability and other performance categories; Promoting Interoperability performance category data submission; call for Promoting Interoperability measures; improvement activities performance category data submission; nomination of improvement activities; and opt-out of Physician Compare for voluntary participants. ICRs for Advanced APMs consist of Partial Qualifying APM participant (QP) election; Other Payer Advanced APM identification: Payer Initiated and Eligible Clinician Initiated Processes; and submission of data for All-Payer QP determinations under the All-Payer Combination Option. The following ICRs reflect this final rule’s policies, as well as policies in the CY 2017 (81 FR 77008) and CY 2018 (82 FR 53568) Quality Payment Program final rules. In discussing each ICR, we reference the specific policies and whether they are finalized in this final rule or finalized in the CY 2017 or CY 2018 Quality Payment Program final rules. As described in this section in more detail, three ICRs (Quality: CMS Web Interface, Promoting Interoperability Performance Category: Data Submission, and Voluntary Participants Election to Opt-Out of Performance Data Display on Physician Compare) show a reduction in burden due to changes in policies that we are finalizing in this final rule. Most of the burden estimates discussed in this section are reductions in burden compared to currently approved estimates and reflect adjustments due to the use of data from the 2017 MIPS performance period or revised perrespondent burden assumptions. Finally, we added one ICR to incorporate a collection previously mentioned in the CY 2018 Quality E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 59994 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations Payment Program final rule for which collection had not yet started: Submission of Data for All-Payer QP Determinations (82 FR 53886). See section V.B.5. of this final rule for a summary of the ICRs, the overall burden estimates, changes in burden estimates due to policies established in this final rule, and a summary of the policy and data changes affecting each ICR. The revised requirements and burden estimates for all Quality Payment Program ICRs (except for CAHPS for MIPS and virtual groups election) will be submitted to OMB for approval under control number 0938–1314 (CMS– 10621). The revised CAHPS for MIPS ICRs will be submitted to OMB for approval under control number 0938– 1222 (CMS–10450). The Virtual Groups Election is approved under OMB control number 0938–1343 (CMS–10652). With regard to Quality Payment Program respondents, we selected BLS occupations Billing and Postal Clerks, Computer Systems Analysts, Physicians, Practice Administrator, and Licensed Practical Nurse (see Wage Estimates in section V.A. of this final rule) based on a study (Casalino et al., 2016) that collected data on the staff in physician’s practices involved in the quality data submission process.42 To calculate the cost for virtual groups to prepare their written formal agreements, we used wage estimates for Legal Support Workers, All Others. Respondent estimates for the quality, Promoting Interoperability, and improvement activities performance categories are modeled using data from the 2017 MIPS performance period with the sole exception of 286 CMS Web Interface respondents, which is based on the number of groups who registered for using the CMS Web Interface during the 2018 MIPS performance period. As discussed in section III.I.3.a. of this final rule, we are finalizing with modification our proposal to expand MIPS to additional clinician types starting with the 2019 MIPS performance period/2021 MIPS payment year; these new clinician types include physical therapists, occupational therapists, qualified speech-language pathologists, qualified audiologists, clinical psychologists, and registered dieticians or nutrition professionals. In addition, in section III.I.3.c. of this final rule, we are finalizing the low-volume threshold in the following manner: If a MIPS eligible clinician meets or exceeds one, but not 42 Lawrence P. Casalino et al., ‘‘US Physician Practices Spend More than $15.4 Billion Annually to Report Quality Measures,’’ Health Affairs, 35, no. 3 (2016): 401–406. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 all, of the low-volume threshold criterion, including as defined by dollar amount ($90,000), beneficiary count (200), or covered professional services to Part-B enrolled individuals (minimum threshold of 200) then the clinician may elect to submit data and opt-in to MIPS. If a MIPS eligible clinician does not meet at least one of these low-volume determinations or meets at least one, but not all, of these low-volume determinations and elects not to opt-in, the clinician is not eligible and is excluded from MIPS. If the clinician is excluded and submits data, the clinician will be a voluntary reporter. These policies will expand the number of potential MIPS eligible clinicians, but we do not anticipate an incremental increase in the burden because the affected clinicians were assumed to be voluntary reporters in prior rules. In the CY 2018 Quality Payment Program final rule, clinicians who participated in 2016 PQRS, and who were not determined to be QPs based on their participation in Advanced APMs during CY 2017 and were not MIPS eligible, were assumed to be voluntary reporters in MIPS (82 FR 53908) with their burden accounted for within our estimates. Therefore, the finalized expansion in MIPS eligibility does not change the total number of respondents, but instead shifts a certain number of assumed voluntary reporters to MIPS eligible clinicians. Additionally, clinicians or groups agreeing to opt-in or voluntarily report will simply select the option of opt-in participation or to remain excluded and voluntarily report prior to submitting data; therefore, we do not believe a commensurate revision to the burden hours is necessary for any of our burden estimates. We realize that clinicians or groups in small practices who submit quality data via Medicare Part B claims do not have to log in the Quality Payment Program portal to submit data; however, we assume the clinicians or groups electing to opt-in would also submit data for the improvement activities performance category as well. Therefore, the effort to elect to opt-in is included in the burden estimate for the improvement activities performance category. We also note that third party intermediaries can be authorized to communicate this opt-in on behalf of clinicians. Our participation estimates are reflected in Tables 64, 65, and 66 for the quality performance category, Table 77 for the Promoting Interoperability performance category, and Table 79 for the improvement activities performance category. PO 00000 Frm 00160 Fmt 4701 Sfmt 4700 Due to data limitations, our burden estimates may overstate the total burden for data submission under the quality, Promoting Interoperability, and improvement activities performance categories. This is due to two primary reasons. First, we anticipate the number of QPs to increase because of total expected growth in Advanced APM participation. The additional QPs will be excluded from MIPS and likely not report. Second, it is difficult to predict what eligible clinicians who may report voluntarily will do in the 2019 MIPS performance period compared to the 2017 MIPS performance period and, therefore, the actual number of participants and how they elect to submit data may be different than our estimates. However, we believe our estimates are the most appropriate given the available data. The following is a summary of general public comments received regarding our request for comment on our information collections and our responses. We received several general comments regarding the burden of data collection associated with the Quality Payment Program. Comment: One commenter requested CMS provide a table in the Collection of Information section of the final rule consistent with the summary table provided in previous years’ final rules which summarizes annual recordkeeping and submission requirements as well as the total burden estimate for the cost of reporting to the Quality Payment Program. The commenter stated its belief that this information is important for policymakers to consider the total cost of pay-for-performance programs in light of the utility of the information collected. Response: We have provided total burden summary information by OMB control number including the total burden estimate for the cost of reporting to the Quality Payment Program in the table notes for Table 91. For more details, please refer to the Supporting Statement A of the Paperwork Reduction Act package for each OMB control number. Comment: One commenter noted that based on the burden estimates provided in the proposed rule as well as the additional time spent analyzing feedback data and implementing care improvements, clinicians and their staff are spending too much time and money reporting data and not enough time on patient care. Further, the commenter requested that CMS continue finalizing policies that will reduce administrative burden and make the Quality Payment E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations Program more cohesive, holistic, and simplified. Response: We will continue refining the Quality Payment Program with the goal of reducing administrative, operational, and reporting burden while balancing the goal of improving quality of care. After consideration of the public comments, we are not making any changes to our burden estimate methodology, but have updated the burden estimates to reflect the availability of participation data from the 2017 MIPS performance period. Framework for Understanding the Burden of MIPS Data Submission: Because of the wide range of information collection requirements under MIPS, Table 61 presents a framework for understanding how the organizations permitted or required to submit data on behalf of clinicians vary across the types of data, and whether the clinician is a MIPS eligible clinician or other eligible clinician voluntarily submitting data, MIPS APM participant, or an Advanced APM participant. As shown in the first row of Table 61, MIPS eligible clinicians that are not in MIPS APMs and other clinicians voluntarily submitting data will submit data either as individuals, groups, or virtual groups for the quality, Promoting Interoperability, and improvement activities performance categories. Note that virtual groups are subject to the same data submission requirements as groups, and therefore, we will refer only to groups for the remainder of this section unless otherwise noted. Because MIPS eligible clinicians are not required to submit any additional information for assessment under the cost performance category, the administrative claims data used for the cost performance category is not represented in Table 61. For MIPS eligible clinicians participating in MIPS APMs, the organizations submitting data on behalf of MIPS eligible clinicians will vary between performance categories and, in some instances, between MIPS APMs. For the 2019 MIPS performance period, the quality data submitted by Shared Savings Program ACOs, Next Generation ACOs, and other APM Entities on behalf of their participant MIPS eligible clinicians will fulfill any MIPS submission requirements for the quality performance category. For the Promoting Interoperability performance category, group TINs may submit data on behalf of eligible clinicians in MIPS APMs, or eligible clinicians in MIPS APMs may submit 59995 data individually. For the improvement activities performance category, we will assume no reporting burden for MIPS APM participants. In the CY 2017 Quality Payment Program final rule, we describe that for MIPS APMs, we compare the requirements of the specific MIPS APM with the list of activities in the Improvement Activities Inventory and score those activities in the same manner that they are otherwise scored for MIPS eligible clinicians (81 FR 77185). Although the policy allows for the submission of additional improvement activities if a MIPS APM receives less than the maximum improvement activities performance category score, to date all MIPS APM have qualified for the maximum improvement activities score. Therefore, we assume that no additional submission will be needed. Advanced APM participants who are determined to be Partial QPs may incur additional burden if they elect to participate in MIPS, which is discussed in more detail in the CY 2018 Quality Payment Program final rule (82 FR 53841 through 53844), but other than the election to participate in MIPS, we do not have data to estimate that burden. TABLE 61—CLINICIANS OR ORGANIZATIONS SUBMITTING MIPS DATA ON BEHALF OF CLINICIANS, BY TYPE OF DATA AND CATEGORY OF CLINICIAN * amozie on DSK3GDR082PROD with RULES3 Type of data submitted Category of clinician Quality performance category Promoting interoperability performance category Improvement activities performance category Other data submitted on behalf of MIPS eligible clinicians MIPS Eligible Clinicians (not in MIPS APMs) and Other Eligible Clinicians Voluntarily Submitting Data a. As group or individual clinicians. As group or individual clinicians. Clinicians who are hospital-based, ambulatory surgical centerbased, non-patient facing, physician assistants, nurse practitioners, clinician nurse specialists, certified registered nurse anesthetists, physical therapists, occupational therapists, qualified speech-language pathologists, qualified audiologists, clinical psychologists, and registered dieticians or nutrition professionals are automatically eligible for a zero percent weighting for the Promoting Interoperability performance category. Clinicians who submit an application and are approved for significant hardship or other exceptions are also eligible for a zero percent weighting. As group or individual clinicians. Groups electing to use a CMS-approved survey vendor to administer CAHPS must register. Groups electing to submit via CMS Web Interface for the first time must register. Virtual groups must register via email. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00161 Fmt 4701 Sfmt 4700 E:\FR\FM\23NOR3.SGM 23NOR3 59996 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations TABLE 61—CLINICIANS OR ORGANIZATIONS SUBMITTING MIPS DATA ON BEHALF OF CLINICIANS, BY TYPE OF DATA AND CATEGORY OF CLINICIAN *—Continued Type of data submitted Category of clinician Quality performance category Promoting interoperability performance category Improvement activities performance category Other data submitted on behalf of MIPS eligible clinicians Eligible Clinicians participating in the Shared Savings Program or Next Generation ACO Model (both MIPS APMs). ACOs submit to the CMS Web Interface and CAHPS for ACOs on behalf of their participating MIPS eligible clinicians. [These submissions are not included in burden estimates for this final rule because quality data submission to fulfill requirements of the Shared Savings Program and for purposes of testing and evaluating the Next Generation ACO Model are not subject to the PRA].b Each MIPS eligible clinician in the APM Entity reports data for the Promoting Interoperability performance category through either group TIN or individual reporting. [Burden estimates for this final rule assume group TIN-level reporting].c Advanced APM Entities will make election for participating MIPS eligible clinicians. Eligible Clinicians participating in Other MIPS APMs. APM Entities submit to MIPS on behalf of their participating MIPS eligible clinicians. [These submissions are not included in burden estimates for this final rule because quality data submission for purposes of testing and evaluating Innovation Center models tested under Section 1115A of the Social Security Act (or Section 3021 of the Affordable Care Act) are not subject to the PRA]. Each MIPS eligible clinician in the APM Entity reports data for the Promoting Interoperability performance category through either group TIN or individual reporting. [The burden estimates for this final rule assume group TIN-level reporting]. CMS will assign the improvement activities performance category score to each APM Entity group based on the activities involved in participation in the Shared Savings Program.d The burden estimates for this final rule assume no improvement activity reporting burden for APM participants because we assume the MIPS APM model provides a maximum improvement activity performance category score.]. CMS will assign the same improvement activities performance category score to each APM Entity based on the activities involved in participation in the MIPS APM. [The burden estimates for this final rule assume no improvement activities performance category reporting burden for APM participants because we assume the MIPS APM model provides a maximum improvement activity score]. Advanced APM Entities will make election for participating eligible clinicians. amozie on DSK3GDR082PROD with RULES3 * Because the cost performance category relies on administrative claims data, MIPS eligible clinicians are not required to provide any additional information, and therefore, the cost performance category is not represented in this table. a Virtual group participation is limited to MIPS eligible clinicians, specifically, solo practitioners and groups consisting of 10 eligible clinicians or fewer. b Sections 1899 and 1115A of the Act (42 U.S.C. 1395jjj and 42 U.S.C. 1315a, respectively) state the Shared Savings Program and testing, evaluation, and expansion of Innovation Center models are not subject to the PRA. c Both group TIN and individual clinician Promoting Interoperability data will be accepted. If both group TIN and individual scores are available for the same APM Entity, CMS will use the higher score for each TIN/NPI. The TIN/NPI scores are then aggregated for purposes of calculating the APM Entity score. d APM Entities participating in MIPS APMs do not need to submit improvement activities data unless the CMS-assigned improvement activities scores are below the maximum improvement activities score. The policies finalized in the CY 2017 and the CY 2018 Quality Payment Program final rules and this final rule create some additional data collection requirements not listed in Table 61. These additional data collections, some of which were previously approved by OMB under the control numbers 0938– 1314 (Quality Payment Program) and 0938–1222 (CAHPS for MIPS), are as follows: Additional approved ICRs related to MIPS third-party intermediaries • Self-nomination of new and returning QCDRs (81 FR 77507 through 77508 and 82 FR 53906 through 53908) (OMB 0938–1314). VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 • Self-nomination of new and returning registries (81 FR 77507 through 77508 and 82 FR 53906 through 53908) (OMB 0938–1314). • Approval process for new and returning CAHPS for MIPS survey vendors (82 FR 53908) (OMB 0938– 1222). Additional ICRs related to the data submission and the quality performance category • CAHPS for MIPS survey completion by beneficiaries (81 FR 77509 and 82 FR 53916 through 53917) (OMB 0938– 1222). PO 00000 Frm 00162 Fmt 4701 Sfmt 4700 • Quality Payment Program Identity Management Application Process (82 FR 53914). Additional ICRs related to the Promoting Interoperability performance category • Reweighting Applications for Promoting Interoperability and other performance categories (82 FR 53918) (OMB 0938–1314). Additional ICRs related to call for new MIPS measures and activities • Nomination of improvement activities (82 FR 53922) (OMB 0938– 1314). E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations • Call for new Promoting Interoperability measures (OMB 0938– 1314). • Call for new quality measures (OMB 0938–1314). Additional ICRs related to MIPS • Opt out of performance data display on Physician Compare for voluntary reporters under MIPS (82 FR 53924 through 53925) (OMB 0938–1314). Additional ICRs related to APMs • Partial QP Election (81 FR 77512 through 77513 and 82 FR 53922 through 53923) (OMB 0938–1314). • Other Payer Advanced APM determinations: Payer Initiated Process (82 FR 53923 through 53924) (OMB 0938–1314). • Other Payer Advanced APM determinations: Eligible Clinician Initiated Process (82 FR 53924) (OMB 0938–1314). • Submission of Data for All-Payer QP Determinations (New data collection for the 2019 performance period) (OMB 0938–1314). 6. Quality Payment Program ICRs Regarding the Virtual Group Election (§ 414.1315) This final rule does not include any new or revised reporting, recordkeeping, or third-party disclosure requirements related to the virtual group election. The virtual group election requirements and burden are currently approved by OMB under control number 0938–1343 (CMS–10652). Consequently, we have not made any virtual group election changes under that control number. amozie on DSK3GDR082PROD with RULES3 7. Quality Payment Program ICRs Regarding Third-Party Intermediaries (§ 414.1400) Under MIPS, the quality, Promoting Interoperability, and improvement activities performance category data may be submitted via relevant thirdparty intermediaries, such as qualified registries, QCDRs, and health IT vendors. Data on the CAHPS for MIPS survey, which counts as one quality performance category measure, or can be used for completion of an improvement activity, can be submitted via CMS-approved survey vendors. In the CY 2018 Quality Payment Program final rule, we combined the burden for self-nomination of qualified registries and QCDRs (82 FR 53906). For this final rule, we determined that requirements for self-nomination for qualified registries were sufficiently different from QCDRs that it is necessary to estimate the two independently. The change will align the burden more closely to the requirements for QCDRs and qualified registries to self-nominate, VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 not because of any change in policy in this final rule, but because of changes in our initial assumptions. Specifically, while the processes for self-nomination are similar, QCDRs have the option to submit QCDR measures for the quality performance category. Therefore, differences between QCDRs and registries self-nomination are associated with the preparation of QCDR measures for approval. The burden associated with qualified registry self-nomination, QCDR self-nomination, and the CAHPS for MIPS survey vendor applications follow: Qualified Registry Self-Nomination: The requirements and burden associated with qualified registry self-nomination will be submitted to OMB for approval under control number 0938–1314 (CMS–10621). Qualified registries interested in submitting MIPS data to us on their participants’ behalf need to complete a self-nomination process to be considered qualified to submit on behalf of MIPS eligible clinicians or groups (82 FR 53815). In the CY 2018 Quality Payment Program final rule, previously approved qualified registries in good standing (that are not on probation or disqualified) that wish to self-nominate using the simplified process can attest, in whole or in part, that their previously approved form is still accurate and applicable (82 FR 53815). In the same rule, qualified registries in good standing that would like to make minimal changes to their previously approved self-nomination application from the previous year, may submit these changes, and attest to no other changes from their previously approved qualified registry application for CMS review during the self-nomination period, from September 1 to November 1 (82 FR 53815). This simplified selfnomination process will begin for the 2019 MIPS performance period. The CY 2017 Quality Payment Program final rule provided the definition of a qualified registry to be a medical registry, a maintenance of certification program operated by a specialty body of the American Board of Medical Specialties or other data intermediary that, with respect to a particular performance period, has selfnominated and successfully completed a vetting process (as specified by CMS) to demonstrate its compliance with the MIPS qualification criteria specified by CMS for that performance period (81 FR 77382). For this final rule, we have adjusted the number of respondents (from 120 to 150) based on more recent data and a revised definition of ‘‘respondent’’ to PO 00000 Frm 00163 Fmt 4701 Sfmt 4700 59997 account for self-nomination applications received but not approved. We have also adjusted our per respondent time estimate (from 10 hours to 3 hours) based on our review of the current burden estimates against the existing policy. Finally, we have provided a range of time estimates (from 10 hours to 0.5 hours) which reflect the availability of a simplified selfnomination process for previously approved qualified registries. For the 2017 MIPS performance period, we received 138 applications for nomination to be a qualified registry and 145 applications for the 2018 MIPS performance period. In continuance of this trend for the 2019 MIPS performance period, we estimate 150 nomination applications will be received from qualified registries desiring approval to report MIPS data, an increase of 30 respondents from our currently approved estimate. For this final rule, the burden associated with qualified registry selfnomination will vary depending on the number of existing qualified registries that will elect to use the simplified selfnomination process in lieu of the full self-nomination process as described in the CY 2018 Quality Payment Program final rule (82 FR 53815). The selfnomination form is submitted electronically using the web-based tool JIRA. For the 2018 MIPS performance period, 141 qualified registries were approved to submit MIPS data. In section III.I.3.k.(3)(a) of this final rule, we have finalized our proposal to modify the definition of a QCDR to be an entity with clinical expertise in medicine and in quality measurement development that collects medical or clinical data on behalf of a MIPS eligible clinician for the purpose of patient and disease tracking to foster improvement in the quality of care provided to patients. This revised definition of a QCDR may result in previously approved QCDRs who no longer meet the new definition to decide to instead seek approval as qualified registries. However, we have not received any notifications of intent and do not have data to support changing our estimate of 150 qualified registries who will submit applications during the self-nomination period for the CY 2020 performance period. In the CY 2018 Quality Payment Program final rule, we estimated the burden associated with self-nomination of a qualified registry to be 10 hours, similar to PQRS (82 FR 53907). For this final rule, we reduced our estimate to 3 hours because registries no longer provide an XML submission, calculated measure, or measure flow as part of the E:\FR\FM\23NOR3.SGM 23NOR3 59998 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations self-nomination process and are not subject to a mandatory interview, which were done previously as part of the PQRS qualified registry self-nomination process, upon which the previous assumption of 10 hours was based. As described in the CY 2017 Quality Payment Program final rule, the full self-nomination process requires the submission of basic information, a description of the process the qualified registry will use for completion of a randomized audit of a subset of data prior to submission, and the provision of a data validation plan along with the results of the executed data validation plan by May 31 of the year following the performance period (81 FR 77383 through 77384). For the simplified self-nomination process, we have estimated 0.5 hours per qualified registry to submit a nomination, a reduction of 9.5 hours from currently approved estimates. As shown in Table 62, we estimate that the staff involved in the qualified registry self-nomination process will be mainly computer systems analysts or their equivalent, who have an adjusted labor cost of $89.18/hour. Assuming that the time associated with the selfnomination process ranges from a minimum of 0.5 hours (for the simplified self-nomination process) to 3 hours (for the full self-nomination process) per qualified registry, we estimate that the annual burden will range from 97.5 hours ([141 qualified registries × 0.5 hr] + [9 qualified registries × 3 hr]) to 450 hours (150 qualified registries × 3 hr) at a cost ranging from $8,695 (97.5 hr × $89.18/ hr) to $40,131 (450 hr × $89.18/hr), respectively (see Table 62). Independent of the change to our per response time estimate, the increase in the number of respondents results in an adjustment of 300 hours and $26,754 (30 registries × 10 hr × $89.18/hr). Accounting for the change in the number of qualified registries, the change in time per qualified registry to self-nominate results in an adjustment of between ¥1,402.5 hours and ¥125,075 ([(141 registries × ¥9.5 hr)] + [(9 registries × ¥7 hr)] at $89.18/hr) and ¥1,050 hours and ¥$93,639 (150 registries × ¥7 hr × $89.18/hr). When these two adjustments are combined, the net impact ranges between ¥1,102.5 (¥1,402.5 + 300) and ¥750 (¥1,050 + 300) hours and ¥$98,321 (¥$125,075 + $26,754) and ¥$66,885 (¥$93,639 + $26,754). Qualified registries must comply with requirements on the submission of MIPS data to CMS. The burden associated with the qualified registry submission requirements will be the time and effort associated with calculating quality measure results from the data submitted to the qualified registry by its participants and submitting these results, the numerator and denominator data on quality measures, the Promoting Interoperability performance category, and improvement activities data to us on behalf of their participants. These requirements are currently approved by OMB under control number 0938–1314 (CMS–10621). We expect that the time needed for a qualified registry to accomplish these tasks will vary along with the number of MIPS eligible clinicians submitting data to the qualified registry and the number of applicable measures. However, we believe that qualified registries already perform many of these activities for their participants. We believe the estimates discussed earlier and shown in Table 62 represents the upper bound of registry burden, with the potential for less additional MIPS burden if the registry already provides similar data submission services. Based on the assumptions previously discussed, we provide an estimate of the total annual burden associated with a qualified registry self-nominating to be considered ‘‘qualified’’ to submit quality measures results and numerator and denominator data on MIPS eligible clinicians. TABLE 62—ESTIMATED BURDEN FOR QUALIFIED REGISTRY SELF-NOMINATION amozie on DSK3GDR082PROD with RULES3 Minimum burden Maximum burden Number of Qualified Registry Simplified Self-Nomination Applications submitted (a) ............................................ Number of Qualified Registry Full Self-Nomination Applications submitted (b) ..................................................... Total Annual Hours Per Qualified Registry for Simplified Process (c) ................................................................... Total Annual Hours Per Qualified Registry for Full Process (d) ............................................................................. 141 9 0.5 3 0 150 0.5 3 Total Annual Hours for Qualified Registries (e) = (a) * (c) + (b) * (d) ............................................................. 97.5 450 Cost Per Simplified Process Per Registry (@computer systems analyst’s labor rate of $89.18/hr.) (f) ................ Cost Per Full Process Per Registry (@computer systems analyst’s labor rate of $89.18/hr.) (g) ......................... $44.59 $267.54 $44.59 $267.54 Total Annual Cost for Qualified Registries (h) = (a) * (f) + (b) * (g) ................................................................ $8,695 $40,131 Both the minimum and maximum burden shown in Table 62 will be submitted for approval to OMB under control number 0938–1314 (CMS– 10621) and reflect adjustments due to review of self-nomination process and the number of respondents. For purposes of calculating total burden associated with the final rule as shown in Table 89, only the maximum burden is used. We received no public comments related to the burden estimates for qualified registry self-nomination. The burden estimates have not been updated VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 from the CY 2019 PFS proposed rule (83 FR 36016 through 36018). QCDR Self-Nomination: 43 The requirements and burden associated with QCDR self-nomination will be submitted to OMB for approval under control number 0938–1314 (CMS– 10621). QCDRs interested in submitting quality, Promoting Interoperability, and improvement activities performance category data to us on their participants’ 43 We do not anticipate any changes in the CEHRT process for health IT vendors as we transition to MIPS. Hence, health IT vendors are not included in the burden estimates for MIPS. PO 00000 Frm 00164 Fmt 4701 Sfmt 4700 behalf will need to complete a selfnomination process to be considered qualified to submit on behalf of MIPS eligible clinicians or groups. In the CY 2018 Quality Payment Program final rule, previously approved QCDRs in good standing (that are not on probation or disqualified) that wish to self-nominate using the simplified process can attest, in whole or in part, that their previously approved form is still accurate and applicable (82 FR 53808). Existing QCDRs in good standing that would like to make minimal changes to their previously approved self-nomination application E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations from the previous year, may submit these changes, and attest to no other changes from their previously approved QCDR application, for CMS review during the self-nomination period, from September 1 to November 1 (82 FR 53808). This simplified self-nomination process will begin for the 2019 MIPS performance period. For this final rule, the burden associated with QCDR self-nomination will vary depending on the number of existing QCDRs that will elect to use the simplified self-nomination process in lieu of the full self-nomination process as described in the CY 2018 Quality Payment Program final rule (82 FR 53808 through 53813). The selfnomination form is submitted electronically using the web-based tool JIRA. For the 2018 MIPS performance period, 150 QCDRs were approved to submit MIPS data. For this CY 2019 Quality Payment Program final rule, we have adjusted the number of respondents (from 113 to 200) based on more recent data and a revised definition of ‘‘respondent’’ to account for self-nomination applications received but not approved. We have also adjusted the time burden estimates per respondent based on our review of the current burden estimates against the existing policy as well as provided a range of time burden estimates which reflect the availability of a simplified self-nomination process for previously approved QCDRs. For the 2017 MIPS performance period, we received 138 self-nomination applications from QCDRs and for the 2018 MIPS performance period, we received 176 self-nomination applications. In continuance of this trend for the 2019 MIPS performance period, we estimate 200 self-nomination applications will be received from QCDRs desiring approval to report MIPS data, an increase of 87 respondents. In section III.I.3.k.(3)(a) of this final rule, we have finalized our proposal to modify the definition of a QCDR to be an entity with clinical expertise in medicine and in quality measurement development that collects medical or clinical data on behalf of a MIPS eligible clinician for the purpose of patient and disease tracking to foster improvement in the quality of care provided to patients. This revised definition of a QCDR may result in previously approved QCDRs who no longer meet the new definition to decide to instead seek approval as qualified registries or collaborate with another previously approved QCDR to meet the requirements of the new definition. However, we have not received any notifications of intent and do not have VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 data to support changing our estimate of 200 QCDRs who will submit applications during the self-nomination period for the CY 2020 performance period. In addition, we have not accounted for any costs associated with QCDRs collaborating to meet the requirements of the new definition as electing to do so would be a business decision made by individual entities which is not required or endorsed by CMS and considering the alternate path of seeking to be a qualified registry would be available for entities seeking to continue participating in MIPS. We estimate that the self-nomination process for QCDRs to submit on behalf of MIPS eligible clinicians or groups for MIPS will involve approximately 3 hours per QCDR to submit information required at the time of self-nomination as described in the CY 2017 Quality Payment Program final rule including basic information about the QCDR, describing the process it will use for completion of a randomized audit of a subset of data prior to submission, providing a data validation plan, and providing results of the executed data validation plan by May 31 of the year following the performance period (81 FR 77383 through 77384). However, for the simplified self-nomination process, we estimate 0.5 hours per QCDR to submit this information. The aforementioned modification to the definition of a QCDR is not expected to affect the estimated time for submitting the full or simplified self-nomination. The self-nomination form is submitted electronically using the web-based tool JIRA. In addition, QCDRs calculate their measure results. QCDRs must possess benchmarking capabilities (for QCDR measures) that compare the quality of care a MIPS eligible clinician provides with other MIPS eligible clinicians performing the same quality measures. For QCDR measures, the QCDR must provide to us, if available, data from years prior (for example, 2017 data for the 2019 MIPS performance period) before the start of the performance period. In addition, the QCDR must provide to us, if available, the entire distribution of the measure’s performance broken down by deciles. As an alternative to supplying this information to us, the QCDR may post this information on their website prior to the start of the performance period, to the extent permitted by applicable privacy laws. The time it takes to perform these functions may vary depending on the sophistication of the entity, but we estimate that a QCDR will spend an additional 1 hour performing these activities per measure and assume PO 00000 Frm 00165 Fmt 4701 Sfmt 4700 59999 that each QCDR will submit information for 9 QCDR measures, for a total burden of 9 hours per QCDR (1 hr per measure × 9 measures). The estimated average of 9 measures per QCDR is based on the number of QCDR measure submissions received in the 2017 and 2018 MIPS performance periods and is the same for each QCDR regardless of whether they elect to use the simplified or full selfnomination process. In the 2017 MIPS performance period, we received over 1,000 QCDR measure submissions. In the 2018 MIPS performance period, we received over 1,400 QCDR measure submissions. For the 2019 MIPS performance period, we anticipate this trend will continue, and therefore, estimate we will receive a total of approximately 1,800 QCDR measure submissions, resulting in an average of 9 measure submissions per QCDR (1,800 measure submissions/200 QCDRs). In the CY 2018 Quality Payment Program final rule, the burden associated with self-nomination of a QCDR was estimated to be 10 hours (82 FR 53907). For this final rule, we are increasing the burden associated with self-nomination to 12 hours. Because QCDRs are no longer required to provide an XML submission and are not subject to a mandatory interview; both of which were completed as part of the PQRS QCDR self-nomination process upon which the previous assumption of 10 hours was based, we are eliminating 1 hour from our previous burden assumption. Simultaneously, we are increasing our burden assumption by 3 hours to account for an increase in the number of QCDR measure submissions being submitted. These two adjustments result in a net increase of 2 hours per respondent from our previously approved burden estimates. As shown in Table 63, we estimate that the staff involved in the QCDR selfnomination process will continue to be computer systems analysts or their equivalent, who have an average labor cost of $89.18/hr. Assuming that the hours per QCDR associated with the self-nomination process ranges from a minimum of 9.5 hours (for the simplified self-nomination process) to 12 hours (for the full self-nomination process), we estimate that the annual burden will range from 2,025 hours ([150 QCDRs × 9.5 hr] + [50 QCDRs × 12 hr]) to 2,400 hours (200 QCDRs × 12 hr) at a cost ranging between $180,590 (2,025 hr × $89.18/hr) and $214,032 (2,400 hr × $89.18/hr), respectively (see Table 63). Independent of the change to our per response time estimate, the increase in the number of respondents results in an E:\FR\FM\23NOR3.SGM 23NOR3 60000 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations adjustment of 870 hours and $77,587 (87 registries × 10 hr × $89.18/hr). Accounting for the change in the number of qualified registries, the change in time per QCDR to selfnominate results in an adjustment of between 25 hours and $2,230 ([150 registries × ¥0.5 hr] + [50 registries × 2 hr] at $89.18/hr) and 400 hours and $35,672 (200 registries × 2 hr × $89.18/ hr). When these two adjustments are combined, the net impact ranges between 895 (870 + 25) hours at $79,817 ($77,587 + $2,230) and 1,270 (870 + 400) hours at $113,259 ($77,587 + $35,672). QCDRs must comply with requirements on the submission of MIPS data to CMS. The burden associated with the QCDR submission requirements will be the time and effort associated with calculating quality measure results from the data submitted to the QCDR by its participants and submitting these results, the numerator and denominator data on quality measures, the Promoting Interoperability performance category, and improvement activities data to us on behalf of their participants. These requirements are currently approved by OMB under control number 0938–1314 (CMS–10621). We expect that the time needed for a QCDR to accomplish these tasks will vary along with the number of MIPS eligible clinicians submitting data to the QCDR and the number of applicable measures. However, we believe that QCDRs already perform many of these activities for their participants. We believe the estimate noted in this section represents the upper bound of QCDR burden, with the potential for less additional MIPS burden if the QCDR already provides similar data submission services. We finalized in the CY 2018 Quality Payment Program final rule that QCDR vendors may seek permission from another QCDR to use an existing measure that is owned by the other QCDR (82 FR 53813). However, some QCDR measure stewards charge a fee for the use of their QCDR measures. We have not accounted for QCDR measure licensing costs as part of our burden estimate due to the election to license a QCDR measure being a business decision made by individual QCDRs which is not required or endorsed by CMS for participation in MIPS. Based on the assumptions previously discussed, we provide an estimate of the total annual burden associated with a QCDR self-nominating to be considered ‘‘qualified’’ to submit quality measures results and numerator and denominator data on MIPS eligible clinicians. TABLE 63—ESTIMATED BURDEN FOR QCDR SELF-NOMINATION amozie on DSK3GDR082PROD with RULES3 Minimum burden Maximum burden Number of QCDR Simplified Self-Nomination Applications submitted (a) .............................................................. Number of QCDR Full Self-Nomination Applications submitted (b) ....................................................................... Total Annual Hours Per QCDR for Simplified Process (c) ..................................................................................... Total Annual Hours Per QCDR for Full Process (d) ............................................................................................... 150 50 9.5 12 0 200 9.5 12 Total Annual Hours for QCDRs (e) = (a) * (c) + (b) * (d) ................................................................................ 2,025 2,400 Cost Per Simplified Process Per QCDR (@computer systems analyst’s labor rate of $89.18/hr.) (f) ................... Cost Per Full Process Per QCDR (@computer systems analyst’s labor rate of $89.18/hr.) (g) ........................... $847.21 $1,070.16 $847.21 $1,070.16 Total Annual Cost for QCDRs (h) = (a) * (f) + (b) * (g) ................................................................................... $180,590 $214,032 Both the minimum and maximum burden shown in Table 63 will be submitted for approval to OMB under control number 0938–1314 (CMS– 10621) and reflect adjustments due to the review of self-nomination process and the number of respondents. For purposes of calculating total burden associated with the final rule as shown in Table 89, only the maximum burden will be used. We received no public comments related to the burden estimates for QCDR self-nomination. The burden estimates have not been updated from the CY 2019 PFS proposed rule (83 FR 36018 through 36019), however we have provided additional elaboration on the updated requirements for QCDRs electing to self-nominate and our rationale for why the burden estimates do not require additional revision. CMS-Approved CAHPS for MIPS Survey Vendors: This rule does not include any new or revised reporting, recordkeeping, or third-party disclosure requirements related to CMS-approved CAHPS for MIPS survey vendors. The VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 CMS-approved CAHPS for MIPS survey vendor requirements and burden are currently approved by OMB under control number 0938–1222 (CMS– 10450). Consequently, we have not made any MIPS survey vendor changes under that control number. 8. Quality Payment Program ICRs Regarding Data Submission (§§ 414.1325 and 414.1335) Under our current policies, two groups of clinicians will submit quality data under MIPS: Those who submit as MIPS eligible clinicians and other eligible clinicians who opt to submit data voluntarily but will not be subject to MIPS payment adjustments. Although the finalized expansion of the definition of a MIPS eligible clinician to new clinician types and the opt-in process for MIPS participation discussed in sections III.I.3.a and III.I.3.c.(6) of this final rule could affect respondent counts, all of the new potential respondents had the opportunity to participate in PQRS and as a voluntary reporter in MIPS. Therefore, consistent PO 00000 Frm 00166 Fmt 4701 Sfmt 4700 with our assumptions in the CY 2017 and CY 2018 Quality Payment Program final rules that PQRS participants that are not QPs will have participated in MIPS as voluntary respondents (81 FR 77501 and 82 FR 53908, respectively), we anticipate that this rule’s finalized expansion of the definition of a MIPS eligible clinician will not have any incremental effect on any of our currently approved burden estimates. For the purpose of the following analyses, we assume that clinicians who participated in MIPS and who are not QPs in Advanced APMs in the 2017 MIPS performance period will continue to submit quality data in the 2019 MIPS performance period. We assume that 100 percent of APM Entities in MIPS APMs will submit quality data to CMS as required under their models. We estimate a total of 964,246 clinicians participated as individuals or groups in the 2017 MIPS performance period; this number differs from the currently approved estimate (OMB 0938–1314, CMS–10621) of 758,267 due to the availability of updated data. E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations As discussed in section III.I.3.h.(1)(b) of this final rule, we are replacing the term ‘‘submission mechanism’’ with the terms ‘‘collection type’’ and ‘‘submission type.’’ ‘‘Submission mechanism’’ is presently used to refer not only to the mechanism by which data is submitted, but also to certain types of measures and activities on which data are submitted to the entities submitting such data in the Quality Payment Program. We assume that clinicians and groups will continue to submit quality data for the same collection types they used during the CY 2017 performance period. In addition, we assume that the 80 TINs that elect to form 16 virtual groups will continue to collect and submit MIPS data using the same collection and submission types as they did during the 2017 MIPS performance period, but the submission will be at the virtual group, rather than group level. Our burden estimates for the quality performance category do not include the burden for the quality data that APM Entities submit to fulfill the requirements of their models. The burden is excluded as sections 1899(e) and 1115A(d)(3) of the Act (42 U.S.C. 1395jjj(e) and 1315a(d)(3), respectively) state the Shared Savings Program and the testing, evaluation, and expansion of Innovation Center models tested under section 1115A of the Act (or section 3021 of the Affordable Care Act) are not subject to the PRA.44 Tables 64, 65, and 66 explain our revised estimates of the number of organizations (including groups, virtual groups, and individual MIPS eligible clinicians) submitting data on behalf of clinicians segregated by collection type. Table 64 provides our estimated counts of clinicians that will submit quality performance category data as MIPS individual clinicians or groups in the 2019 MIPS performance period based on data from the 2017 MIPS performance period. For the 2019 MIPS performance period, respondents will have the option to submit quality performance category data via Medicare Part B claims, direct, and log in and upload submission types, and CMS Web Interface. At the time of the CY 2019 PFS proposed rule, participation data by submission type and user research data to inform burden assumptions was not available to estimate burden by submission type. As a result, we estimate the burden for collecting data via collection type: Claims, QCDR and MIPS CQMs, eCQMs, and the CMS Web Interface. While we have more information about MIPS submissions, for this final rule, we believe it is important to continue to estimate burden by collection type because the public was able to comment on our assumptions using this framework. As we gain more experience with the program, we may revise this approach through future rulemaking. For the Medicare Part B claims collection type, in section III.I.3.h.(1)(b) of this rule, we finalized limiting the Medicare Part B claims collection type to small practices beginning with the 2021 MIPS payment year and allowing clinicians in small practices to report Medicare Part B claims as a group or as individuals. We assumed in our currently approved burden analysis that any clinician that submits quality data codes to us for the Medicare Part B claims collection type is intending to do so for the Quality Payment Program. We made this assumption originally in the CY 2017 Quality Payment Program final rule to ensure that we fully accounted for any burden that may have resulted from our policies (81 FR 77501 through 77504). In some cases, however, clinicians may be submitting quality data codes not only for the Medicare Part B claims collection type, but also for MIPS CQM and QCDR collection types. Some registries and QCDRs utilize data from claims to populate their datasets when submitting on behalf of clinicians. We are not able to separate out when a clinician submits a quality data code solely for the Medicare Part B claim collection type or when a clinician is also submitting these codes for MIPS CQM or QCDR collection types. In addition, we see a large number of voluntary reporters for the Medicare Part B claims collection type. Approximately 70 percent of the 257,260 clinicians we estimate will submit quality data via Medicare Part B claims (see Table 64) are MIPS eligible clinicians while the other 30 percent are voluntary reporters which means our burden include estimates for a large number of voluntary reporters. Of these clinicians who are not scored as part of an APM, approximately 55 percent are in practices with more than 15 clinicians; however, over 91 percent of the number in practices larger than 15 clinicians are either voluntary reporters, group reporters, or are also reporting quality data through another collection type. Approximately 10,700 individual clinicians in non-small practices are both MIPS eligible and scored based 44 Our estimates do reflect the burden on MIPS APM participants of submitting Promoting Interoperability performance category data, which is outside the requirements of their models. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00167 Fmt 4701 Sfmt 4700 60001 only on Medicare Part B claims data and of these, 52 percent also qualify for facility-based reporting, and therefore, will not be required to submit quality data in order to receive facility-based quality and cost scores. It is unclear why many clinicians are submitting quality data via an alternate collection type, and we currently lack data to accurately estimate both the number of clinicians who will be impacted by these finalized policies and the potential behavioral response of those clinicians who will be required to switch to another collection type. As a result, we will continue using the assumption that all clinicians (except QPs) who submitted data via the Medicare Part B claims collection type in the 2017 MIPS performance period will continue to do so for MIPS in order to avoid overstating the impact of the change. We intend to update this burden estimate with additional data as it becomes available. We solicited comment on potential other assumptions for capturing the Medicare Part B claims burden, but no comments were received. Using our revised terminology, clinicians who used a QCDR or Registry will now collect measures via QCDR or MIPS CQM collection type; clinicians who used the EHR submission type will elect the eCQM collection type, and groups that elected the CMS Web Interface for MIPS will continue to elect the CMS Web Interface for MIPS. Table 64 shows that in the 2019 MIPS performance period, an estimated 257,260 clinicians will submit data as individuals for the Medicare Part B claims collection type; 324,693 clinicians will submit data as individuals or as part of groups for the MIPS CQM or QCDR collection types; 243,062 clinicians will submit data as individuals or as part of groups via eCQM collection types; and 139,231 clinicians will submit as part of groups via the CMS Web Interface. Table 64 provides estimates of the number of clinicians to collect quality measures data via each collection type, regardless of whether they decide to submit as individual clinicians or as part of groups. Because our burden estimates for quality data submission assume that burden is reduced when clinicians elect to submit as part of a group, we also separately estimate the expected number of clinicians to submit as individuals or part of groups. E:\FR\FM\23NOR3.SGM 23NOR3 60002 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations TABLE 64—ESTIMATED NUMBER OF CLINICIANS SUBMITTING QUALITY PERFORMANCE CATEGORY DATA BY COLLECTION TYPE Medicare Part B claims Number of clinicians to collect data by collection type (as individual clinicians or groups) in Quality Payment Program Year 3 (excludes QPs) (a) ...................................... * Number of clinicians to collect data by collection type (as individual clinicians or groups) in Quality Payment Program Year 2 (excludes QPs) (b) ...................................... Difference between Year 3 and Year 2 (c) = (a) ¥ (b) ...... QCDR/MIPS CQM eCQM CMS web interface Total 257,260 324,693 243,062 139,231 964,246 278,039 ¥20,779 255,228 +69,465 131,133 +111,929 93,867 +45,364 758,267 +205,979 * Currently approved by OMB under control number 0938–1314 (CMS–10621). In the CY 2018 Quality Payment Program final rule (82 FR 53625 through 53626), beginning with the 2019 MIPS performance period, we allowed MIPS eligible clinicians to submit data for multiple collection types for a single performance category. Therefore, we captured the burden of any eligible clinician that may have historically collected via multiple collection types, as we assume they will continue to collect via multiple collection types and that our MIPS scoring methodology will take the highest score where the same measure is submitted via multiple collection types. Hence, the estimated numbers of individual clinicians and groups to collect via the various collection types are not mutually exclusive and reflect the occurrence of individual clinicians or groups that collected data via multiple collection types during the MIPS 2017 performance period. Table 65 uses methods similar to those described for Table 64 to estimate the number of clinicians that will submit data as individual clinicians via each collection type in the 2019 MIPS performance period. We estimate that approximately 257,260 clinicians will submit data as individuals using the Medicare Part B claims collection type; approximately 71,439 clinicians will submit data as individuals using MIPS CQMs or QCDR collection types; and approximately 47,557 clinicians will submit data as individuals using eCQMs collection type. TABLE 65—ESTIMATED NUMBER OF CLINICIANS SUBMITTING QUALITY PERFORMANCE CATEGORY DATA AS INDIVIDUALS BY COLLECTION TYPE Medicare Part B claims Number of Clinicians to submit data as individuals in Quality Payment Program Year 3 (excludes QPs) (a) ............ * Number of Clinicians to submit data as individuals in Quality Payment Program Year 2 (excludes QPs) (b) .... Difference between Year 3 and Year 2 (c) = (a) ¥ (b) ...... QCDR/MIPS CQM eCQM CMS web interface Total 257,260 71,439 47,557 0 376,256 278,039 ¥20,779 104,281 ¥32,842 52,709 ¥5,152 0 0 435,029 ¥58,773 amozie on DSK3GDR082PROD with RULES3 * Currently approved by OMB under control number 0938–1314 (CMS–10621). To be consistent with the policy in the CY 2018 Quality Payment Program final rule that for MIPS eligible clinicians who collect measures via Medicare Part B claims, MIPS CQM, eCQM, or QCDR collection types and submit more than the required number of measures (82 FR 53735 through 54736), we will score the clinician on the required measures with the highest assigned measure achievement points. Therefore, our columns in Table 65 are not mutually exclusive. Table 66 provides our estimated counts of groups or virtual groups that will submit quality data on behalf of clinicians for each collection type in the 2019 MIPS performance period and reflects our assumption that the formation of virtual groups will reduce burden. We assume that groups that submitted quality data as groups in the 2017 MIPS performance period will continue to submit quality data either as groups or virtual groups for the same collection types as they did as a group VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 or TIN within a virtual group for the 2019 MIPS performance period. First, we estimated the number of groups or virtual groups that will collect data via each collection type during the 2019 MIPS performance period using data from the 2017 MIPS performance period. The second and third steps in Table 66 reflect our currently approved assumption that virtual groups will reduce the burden for quality data submission by reducing the number of organizations that will submit quality data on behalf of clinicians. We assume that 40 groups that previously collected on behalf of clinicians via QCDR or MIPS CQM collection types will elect to form 8 virtual groups that will collect via QCDR and MIPS CQM collection types. We assume that another 40 groups that previously collected on behalf of clinicians via eCQM collection types will elect to form another 8 virtual groups that will collect via eCQM collection types. Hence, the second step in Table 66 is to subtract out the PO 00000 Frm 00168 Fmt 4701 Sfmt 4700 estimated number of groups under each collection type that will elect to form virtual groups, and the third step in Table 66 is to add in the estimated number of virtual groups that will submit on behalf of clinicians for each collection type. Specifically, we assume that 10,542 groups and virtual groups will submit data for the QCDR or MIPS CQM collection types on behalf of 253,254 clinicians; 4,304 groups and virtual groups will submit for eCQM collection types on behalf of 195,505 eligible clinicians; and 286 groups will submit data via the CMS Web Interface on behalf of 139,231 clinicians. Because we are using 2017 MIPS performance period participation data to estimate participation for the 2019 MIPS performance period, our estimates do not account for the finalized policy to allow only groups that meet the definition of a small practice to submit quality data via the Medicare Part B claims collection type. Due to a lack of E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations historic data identifying which clinicians in small practices would want to submit via the Medicare Part B claims collection type and elect to be measured as part of a group, we continue to assume these clinicians submitting Medicare Part B claims will participate as individuals but will review this 60003 assumption for future performance periods. TABLE 66—ESTIMATED NUMBER OF GROUPS AND VIRTUAL GROUPS SUBMITTING QUALITY PERFORMANCE CATEGORY DATA BY COLLECTION TYPE ON BEHALF OF CLINICIANS Medicare Part B claims Number of groups to collect data by collection type (on behalf of clinicians) in Quality Payment Program Year 3 (excludes QPs) (a) ........................................................... Subtract out: Number of groups to collect data by collection type on behalf of clinicians in Quality Payment Program Year 3 that will submit as virtual groups in Quality Payment Program Year 3 (b) ........................................... Add in: Number of virtual groups to collect data by collection type on behalf of clinicians in Quality Payment Program Year 3 (c) ................................................................ Number of groups to collect data by collection type on behalf of clinicians in Quality Payment Program Year 3 (d) = (a)¥(b) + (c) ................................................................. * Number of groups to collect data by collection type on behalf of clinicians in Quality Payment Program Year 2 (e) ..................................................................................... Difference between Year 3 and Year 2 (f) = (d)¥(e) ......... QCDR/MIPS CQM CMS web interface eCQM Total 0 10,574 4,336 286 15,196 0 40 40 0 80 0 8 8 0 16 0 10,542 4,304 286 15,132 0 0 2,936 +7,606 1,509 +2,795 296 ¥10 4,741 +10,391 * Currently approved by OMB under control number 0938–1314 (CMS–10621). The burden estimates associated with submission of quality performance category data have some limitations. We believe it is difficult to quantify the burden accurately because clinicians and groups may have different processes for integrating quality data submission into their practices’ work flows. Moreover, the time needed for a clinician to review quality measures and other information, select measures applicable to their patients and the services they furnish, and incorporate the use of quality measures into the practice workflows is expected to vary along with the number of measures that are potentially applicable to a given clinician’s practice and by the collection type. For example, clinicians submitting data via the Medicare Part B claims collection type need to integrate the capture of quality data codes for each encounter whereas clinicians submitting via the eCQM collection types may have quality measures automated as part of their EHR implementation. We believe the burden associated with submitting quality measures data will vary depending on the collection type selected by the clinician, group, or third-party. As such, we separately estimated the burden for clinicians, groups, and third parties to submit quality measures data by the collection type used. For the purposes of our burden estimates for the Medicare Part B claims, MIPS CQM and QCDR, and eCQM collection types, we also assume that, on average, each clinician or group will submit 6 quality measures. In terms of the quality measures available for clinicians and groups to report for the 2019 MIPS performance period, the total number of quality measures will be 257. These measures are stratified by collection type in Table 67, as well as counts of new, removed, and substantively changed measures. TABLE 67—SUMMARY OF QUALITY MEASURES FOR THE 2019 MIPS PERFORMANCE PERIOD Number of measures finalized as new amozie on DSK3GDR082PROD with RULES3 Collection type Number of measures finalized for removal Number of measures finalized with a substantive change Number of measures remaining for CY 2019 Medicare Part B Claims Specifications ........................................................... MIPS CQMs Specifications ............................................................................. eCQM Specifications ....................................................................................... Survey—CSV ................................................................................................... CMS Web Interface Measure Specifications ................................................... Administrative Claims ...................................................................................... 0 6 2 0 0 0 7 21 6 0 1 0 1 0 0 0 4 0 64 233 50 1 10 1 Total .......................................................................................................... 8 * 26 5 * 257 * A measure may be applicable to more than one collection type but will only be counted once in the total. For the 2019 MIPS performance period, there is a net reduction of 18 quality measures across all collection types. We do not anticipate that VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 removing these measures will increase or decrease the reporting burden on clinicians and groups. PO 00000 Frm 00169 Fmt 4701 Sfmt 4700 Quality Payment Program Identity Management Application Process: The requirements and burden associated with the application process will be E:\FR\FM\23NOR3.SGM 23NOR3 60004 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations submitted to OMB for approval under control number 0938–1314 (CMS– 10621). In the CY 2018 Quality Payment Program final rule, the time associated with the Identity Management Application Process was described as ‘‘Obtain Account in CMS-Specified Identity Management System’’ and included in the ICR for Quality Data Submission by Clinicians and Groups: EHR Submission for a total burden of 54,218 hours (1 hr × 54,218 respondents) (82 FR 53914). After our review of the quality data submission process, we determined the burden associated with the application process (3,741 hours) should be accounted for in a separate ICR. Our per respondent burden estimate remains unchanged at 1 hour per response. For an individual, group, or thirdparty to submit MIPS quality, improvement activities, or Promoting Interoperability performance category data using either the log in and upload or the log in and attest submission type or to access feedback reports, the submitter must have a CMS Enterprise Portal user account. Once the user account is created, registration is not required again for future years. Based on the number of new TINs registered in the 2017 MIPS performance period, we estimate 3,741 eligible clinicians, groups, or thirdparties will register for new accounts for the 2019 MIPS performance period. As shown in Table 68, it will take 1 hour at $89.18/hr for a computer systems analyst (or their equivalent) to obtain an account for the CMS Enterprise Portal. In aggregate, we estimate an annual burden of 3,741 hours (3,741 registrations × 1 hr/registration) at a cost of $333,622 (3,741 hr × $89.18/hr) or $89.18 per registration. TABLE 68—ESTIMATED BURDEN FOR QUALITY PAYMENT PROGRAM IDENTITY MANAGEMENT APPLICATION PROCESS amozie on DSK3GDR082PROD with RULES3 Burden estimate Number of New TINs completing the Identity Management Application Process (a) ........................................................................ 3,741 Total Hours Per Application (b) ........................................................................................................................................................... 1 Total Annual Hours for completing the Identity Management Application Process (c) = (a) * (b) .............................................. 3,741 Cost Per Application @ computer systems analyst’s labor rate of $89.18/hr.) (d) ............................................................................ $89.18 Total Annual Cost for completing the Identity Management Application Process (e) = (a) * (d) ................................................ $333,622 We received no public comments related to the burden estimates for the Identity Management Application Process. The burden estimates have not been updated from the CY 2019 PFS proposed rule (83 FR 36022 through 36023). Quality Data Submission by Clinicians: Medicare Part B ClaimsBased Collection Type: The requirements and burden associated with clinicians’ Medicare Part B claimsbased data submissions will be submitted to OMB for approval under control number 0938–1314 (CMS– 10621). As noted in Table 64, based on 2017 MIPS performance period data, we assume that 257,260 individual clinicians will collect and submit quality data via the Medicare Part B claims collection type. We continue to anticipate that the Medicare Part B claims submission process for MIPS is operationally similar to the way the claims submission process functioned under the PQRS. Specifically, clinicians will need to gather the required information, select the appropriate QDCs, and include the appropriate QDCs on the Medicare Part B claims they submit for payment. Clinicians will collect QDCs as additional (optional) line items on the CMS–1500 claim form or the electronic equivalent HIPAA transaction 837–P, approved by OMB under control number 0938–1197. This VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 final rule’s provisions do not necessitate the revision of either form. In this final rule, we have adjusted the number of respondents based on more recent data and adjusted our per respondent time estimates so that they correctly align with the number of required measures for which MIPS data must be submitted (6 measures) in comparison to the number of measures previously required under PQRS (9 measures). The total estimated burden of Medicare Part B claims-based submission will vary along with the volume of Medicare Part B claims on which the submission is based. Based on our experience with PQRS, we estimate that the burden for submission of MIPS quality data will range from 0.15 to 7.2 hours per clinician, a reduction from the range of 0.22 to 10.8 hours as set out in the CY 2018 Quality Payment Program final rule (82 FR 53912). In the same rule, the 33 percent reduction in the number of measures (from 9 to 6) was erroneously omitted from our burden calculations; it is reflected in this final rule’s burden estimates. The wide range of estimates for the time required for a clinician to submit quality measures via Medicare Part B claims reflects the wide variation in complexity of submission across different clinician quality measures. As shown in Table 69, we estimate that the cost of quality data submission using PO 00000 Frm 00170 Fmt 4701 Sfmt 4700 Medicare Part B claims will range from $13.38 (0.15 hr × $89.18/hr) to $642.10 (7.2 hr × $89.18/hr). The burden will involve becoming familiar with MIPS data submission requirements. We believe that the start-up cost for a clinician’s practice to review measure specifications is 7 hours, consisting of 3 hours at $107.38/hr for a practice administrator, 1 hour at $206.44/hr for a clinician, 1 hour at $43.96/hr for an LPN/medical assistant, 1 hour at $89.18/ hr for a computer systems analyst, and 1 hour at $36.98/hr for a billing clerk. The estimate for reviewing and incorporating measure specifications for the claims collection type is higher than that of QCDRs/Registries or eCQM collection types due to the more manual, and therefore, more burdensome nature of claims measures. Considering both data submission and start-up requirements, the estimated time (per clinician) ranges from a minimum of 7.15 hours (0.15 hr + 7 hr) to a maximum of 14.2 hours (7.2 hr + 7 hr). In this regard the total annual burden ranges from 1,819,082 hours (7.15 hr × 254,417 clinicians) to 3,612,721 hours (14.2 hr × 254,417 clinicians). The estimated annual cost (per clinician) ranges from $712.08 ($13.38 + $322.14 + $89.18 + $43.96 + $36.98 + $206.44) to a maximum of $1,340.80 ($642.10 + $322.14 + $89.18 + $43.96 + $36.98 + $206.44). The total annual burden ranges from a minimum E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations of $183,189,701 (257,260 clinicians × $712.08) to a maximum of $344,934,208 (257,260 clinicians × $1,340.80). Table 69 summarizes the range of total annual burden associated with clinicians submitting quality data via Medicare Part B claims. Independent of the change in the number of respondents, the change in estimated time per clinician results in a burden adjustment of between ¥19,463 hours at ¥$1,860,081 (278,039 clinicians × ¥0.07 hr × $89.18/hr) and ¥1,000,941 hours at ¥$89,261,641 (278,039 clinicians × ¥3.6 hr × $89.18/ hr). Accounting for the change in the time burden per respondent, the decrease in number of respondents results in a total adjustment of between ¥148,713 hours at ¥$14,810,552 (¥20,799 respondents × $712.08/ respondent) and ¥295,346 hours at 60005 ¥$27,887,299 (¥20,779 respondents × $1,340.80/respondent). When these two adjustments are combined, the net adjustment ranges between ¥168,176 (¥19,463 ¥148,713) hours at ¥$16,670,633 (¥$1,860,081 ¥$14,810,552) and ¥1,296,287 (¥1,000,941 ¥295,346) hours at ¥$117,148,940 (¥$89,261,641 ¥$27,887,299). TABLE 69—ESTIMATED BURDEN FOR QUALITY PERFORMANCE CATEGORY: CLINICIANS USING THE MEDICARE PART B CLAIMS COLLECTION TYPE amozie on DSK3GDR082PROD with RULES3 Minimum burden Median burden Maximum burden estimate Number of Clinicians (a) .............................................................................................................. Hours Per Clinician to Submit Quality Data (b) .......................................................................... Number of Hours Practice Administrator Review Measure Specifications (c) ............................ Number of Hours Computer Systems Analyst Review Measure Specifications (d) ................... Number of Hours LPN Review Measure Specifications (e) ........................................................ Number of Hours Billing Clerk Review Measure Specifications (f) ............................................. Number of Hours Clinician Review Measure Specifications (g) ................................................. Annual Hours per Clinician (h) = (b) + (c) + (d) + (e) + (f) + (g) ................................................ 257,260 0.15 3 1 1 1 1 7.15 257,260 1.05 3 1 1 1 1 8.05 257,260 7.2 3 1 1 1 1 14.2 Total Annual Hours (i) = (a) * (h) ......................................................................................... 1,839,409 2,070,943 3,653,092 Cost to Submit Quality Data (@ computer systems analyst’s labor rate of $89.18/hr.) (j) ........ Cost to Review Measure Specifications (@ practice administrator’s labor rate of $107.38/hr.) (k) ............................................................................................................................................. Cost to Review Measure Specifications (@ computer systems analyst’s labor rate of $89.18/ hr.) (l) ........................................................................................................................................ Cost to Review Measure Specifications (@ LPN’s labor rate of $43.96/hr.) (m) ....................... Cost to Review Measure Specifications (@ billing clerk’s labor rate of $36.98/hr.) (n) ............. Cost to Review Measure Specifications (@ physician’s labor rate of $206/44/hr.) (o) .............. $13.38 $93.64 $642.10 $322.14 $322.14 $322.14 $89.18 $43.96 $36.98 $206.44 $89.18 $43.96 $36.98 $206.44 $89.18 $43.96 $36.98 $206.44 Total Annual Cost Per Clinician (p) = (j) + (k) + (l) + (m) + (n) + (o) .................................. $712.08 $792.34 $1,340.80 Total Annual Cost (q) = (a) * (p) ................................................................................... $183,189,701 $203,837,388 $344,934,208 We received no public comments related to the burden estimates for quality performance category: Clinicians using the Medicare Part B claims collection type. However, the burden estimates have been updated from the CY 2019 PFS proposed rule to reflect availability of data from the 2017 MIPS performance period (83 FR 36023 through 36024). Quality Data Submission by Individuals and Groups Using MIPS CQM and QCDR Collection Types: This final rule does not include any new or revised reporting, recordkeeping, or third-party disclosure requirements related to this CQM and QCDR collection types. However, we have adjusted the number of respondents based on more recent data. The adjusted burden will be submitted to OMB for approval under control number 0938– 1314 (CMS–10621). As noted in Tables 64, 65, and 66, and based on 2017 MIPS performance period data, we assume that 324,693 clinicians will submit quality data as individuals VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 or groups using MIPS CQM or QCDR collection types. Of these, we expect 71,439 clinicians, as shown in Table 65, will submit as individuals and 10,542 groups, as shown in Table 66, are expected to submit on behalf of the remaining 253,254 clinicians. Given that the number of measures required is the same for clinicians and groups, we expect the burden to be the same for each respondent collecting data via MIPS CQM or QCDR, whether the clinician is participating in MIPS as an individual or group. Under the MIPS CQM and QCDR collection types, the individual clinician or group may either submit the quality measures data directly to us, log in and upload a file, or utilize a thirdparty intermediary to submit the data to us on the clinician’s or group’s behalf. We estimate that the burden associated with the QCDR collection type is similar to the burden associated with the MIPS CQM collection type; therefore, we discuss the burden for both together below. For MIPS CQM and PO 00000 Frm 00171 Fmt 4701 Sfmt 4700 QCDR collection types, we estimate an additional time for respondents (individual clinicians and groups) to become familiar with MIPS submission requirements and, in some cases, specialty measure sets and QCDR measures. Therefore, we believe that the burden for an individual clinician or group to review measure specifications and submit quality data total 9.083 hours at $858.86. This consists of 3 hours at $89.18/hr for a computer systems analyst (or their equivalent) to submit quality data along with 2 hours at $107.38/hr for a practice administrator, 1 hour at $89.18/hr for a computer systems analyst, 1 hour at $43.96/hr for a LPN/medical assistant, 1 hour at $36.98/hr for a billing clerk, and 1 hour at $206.44/hr for a clinician to review measure specifications. Additionally, clinicians and groups will need to authorize or instruct the qualified registry or QCDR to submit quality measures’ results and numerator and denominator data on quality measures to us on their behalf. We E:\FR\FM\23NOR3.SGM 23NOR3 60006 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations estimate that the time and effort associated with authorizing or instructing the quality registry or QCDR to submit this data will be approximately 5 minutes (0.083 hours) per clinician or group (respondent) for a cost of $7.40 (0.083 hr × $89.18/hr for a computer systems analyst). In aggregate, we estimate an annual burden of 744,633 hours (9.083 hr/ response × 81,981 groups plus clinicians submitting as individuals) at a cost of $71,016,861 (81,981 responses × $866.26/response). The decrease in number of respondents results in a total adjustment of ¥229,219 hours at ¥$21,860,937 (¥25,236 respondents × $866.26/respondent). Based on these assumptions, we have estimated in Table 70 the burden for these submissions. TABLE 70—ESTIMATED BURDEN FOR QUALITY PERFORMANCE CATEGORY: CLINICIANS (PARTICIPATING INDIVIDUALLY OR AS PART OF A GROUP) USING THE MIPS CQM/QCDR COLLECTION TYPE amozie on DSK3GDR082PROD with RULES3 Burden estimate Number of clinicians submitting as individuals (a) .............................................................................................................................. Number of groups submitting via QCDR or MIPS CQM on behalf of individual clinicians (b) ........................................................... Number of Respondents (groups plus clinicians submitting as individuals) (c) = (a) + (b) ................................................................ Hours Per Respondent to Report Quality Data (d) ............................................................................................................................. Number of Hours Practice Administrator Review Measure Specifications (e) ................................................................................... Number of Hours Computer Systems Analyst Review Measure Specifications (f) ............................................................................ Number of Hours LPN Review Measure Specifications (g) ................................................................................................................ Number of Hours Billing Clerk Review Measure Specifications (h) .................................................................................................... Number of Hours Clinician Review Measure Specifications (i) .......................................................................................................... Number of Hours Per Respondent to Authorize Qualified Registry to Report on Respondent’s Behalf (j) ....................................... Annual Hours Per Respondent (k) = (d) + (e) + (f) + (g) + (h) + (i) + (j) ........................................................................................... 71,439 10,542 81,981 3 2 1 1 1 1 0.083 9.083 Total Annual Hours (l) = (c) * (k) ................................................................................................................................................. 744,633 Cost Per Respondent to Submit Quality Data (@ computer systems analyst’s labor rate of $89.18/hr.) (m) ................................... Cost to Review Measure Specifications (@ practice administrator’s labor rate of $107.38/hr.) (n) .................................................. Cost Computer System’s Analyst Review Measure Specifications (@ computer systems analyst’s labor rate of $89.18/hr.) (o) ... Cost LPN Review Measure Specifications (@ LPN’s labor rate of $43.96/hr.) (p) ............................................................................ Cost Billing Clerk Review Measure Specifications (@ clerk’s labor rate of $36.98/hr.) (q) ............................................................... Cost Clinician Review Measure Specifications (@ physician’s labor rate of $206.44/hr.) (r) ............................................................ Cost for Respondent to Authorize Qualified Registry/QCDR to Report on Respondent’s Behalf (@ computer systems analyst’s labor rate of $89.18/hr.) (s) .............................................................................................................................................................. $267.54 $214.76 $89.18 $43.96 $36.98 $206.44 Total Annual Cost Per Respondent (t) = (m) + (n) + (o) + (p) + (q) + (r) + (s) ........................................................................... $866.26 Total Annual Cost (u) = (c) * (t) ............................................................................................................................................ $71,016,861 We received no public comments related to the burden estimates for quality performance category: Clinicians using the MIPS CQM/QCDR collection type. However, the burden estimates have been updated from the CY 2019 PFS proposed rule to reflect availability of data from the 2017 MIPS performance period (83 FR 36024 through 36025). Quality Data Submission by Clinicians and Groups: eCQM Collection Type: This final rule does not include any new or revised reporting, recordkeeping, or third-party disclosure requirements related to the eCQM collection type. However, we have adjusted the number of respondents based on more recent data. The adjusted burden will be submitted to OMB for approval under control number 0938– 1314 (CMS–10621). As noted in Tables 64, 65, and 66, based on 2017 MIPS performance period data, we assume that 243,062 clinicians will elect to use the eCQM collection type; 47,557 clinicians are expected to submit eCQMs as individuals; and 4,304 groups are expected to submit eCQMs VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 on behalf of the remaining 195,505 clinicians. We expect the burden to be the same for each respondent using the eCQM collection type, whether the clinician is participating in MIPS as an individual or group. In the CY 2018 Quality Payment Program final rule, the time required for users to obtain an account for the CMS Enterprise Portal was included in this Quality Data Submission by Clinicians and Groups: eCQM Collection Type ICR (82 FR 53914). However, in this final rule, we are finalizing a separate ICR for this activity (now described as the Quality Payment Program Identity Management Application Process; see Table 68) and therefore, reduce (by 1 hour) our per respondent burden estimate for this ICR commensurately. We have also adjusted the number of respondents based on more recent data. Under the eCQM collection type, the individual clinician or group may either submit the quality measures data directly to us from their eCQM, log in and upload a file, or utilize a health IT PO 00000 Frm 00172 Fmt 4701 Sfmt 4700 $7.40 vendor to submit the data to us on the clinician’s or group’s behalf. To prepare for the eCQM collection type, the clinician or group must review the quality measures on which we will be accepting MIPS data extracted from eCQMs, select the appropriate quality measures, extract the necessary clinical data from their CEHRT, and submit the necessary data to the CMS-designated clinical data warehouse or use a health IT vendor to submit the data on behalf of the clinician or group. We assume the burden for collecting quality measures data via eCQM is similar for clinicians and groups who submit their data directly to us from their CEHRT and clinicians and groups who use a health IT vendor to submit the data on their behalf. This includes extracting the necessary clinical data from their CEHRT and submitting the necessary data to the CMS-designated clinical data warehouse. We continue to estimate that it will take no more than 2 hours at $89.18/hr for a computer systems analyst to submit the actual data file. The burden E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations will also involve becoming familiar with MIPS submission. In this regard, we estimate it will take 6 hours for a clinician or group to review measure specifications. Of that time, we estimate 2 hours at $107.38/hr for a practice administrator, 1 hour at $206.44/hr for a clinician, 1 hour at $89.18/hr for a computer systems analyst, 1 hour at $43.96/hr for a LPN/medical assistant, and 1 hour at $36.98/hr for a billing clerk. In aggregate we estimate an annual burden of 414,888 hours (8 hr × 51,861 groups and clinicians submitting as individuals) at a cost of $39,916,374 (51,861 responses × $769.68/response) (see Table 71). Independent of the change in the number of respondents, removing the time burden associated with completing the Quality Payment Program Identity Management Application Process results in an adjustment to the total burden of ¥54,218 hours and 60007 ¥$4,835,161 (54,218 respondents × ¥1 hr × $89.18/hr). Accounting for the change in the per respondent time estimate, the decrease in number of respondents results in a total adjustment of ¥18,856 hours at ¥$1,814,136 (¥2,357 respondents × $769.68/ respondent). When these two adjustments are combined, the net adjustment is ¥73,074 (¥54,218– 18,856) hours at ¥$6,649,297 (¥$4,835,161–$1,814,136). TABLE 71—ESTIMATED BURDEN FOR QUALITY PERFORMANCE CATEGORY: CLINICIANS (SUBMITTING INDIVIDUALLY OR AS PART OF A GROUP) USING THE ECQM COLLECTION TYPE Burden estimate Number of clinicians submitting as individuals (a) .............................................................................................................................. Number of Groups submitting via EHR on behalf of individual clinicians (b) ..................................................................................... Number of Respondents (groups and clinicians submitting as individuals) (c) = (a) + (b) ................................................................ Hours Per Respondent to Submit MIPS Quality Data File to CMS (d) .............................................................................................. Number of Hours Practice Administrator Review Measure Specifications (e) ................................................................................... Number of Hours Computer Systems Analyst Review Measure Specifications (f) ............................................................................ Number of Hours LPN Review Measure Specifications (g) ................................................................................................................ Number of Hours Billing Clerk Review Measure Specifications (h) .................................................................................................... Number of Hours Clinicians Review Measure Specifications (i) ......................................................................................................... Annual Hours Per Respondent (j) = (d) + (e) + (f) + (g) + (h) + (i) .................................................................................................... 47,557 4,304 51,861 2 2 1 1 1 1 8 Total Annual Hours (k) = (c) * (j) ................................................................................................................................................. 414,888 amozie on DSK3GDR082PROD with RULES3 Cost Cost Cost Cost Cost Cost Per Respondent to Submit Quality Data (@ computer systems analyst’s labor rate of $88.10/hr.) (l) ..................................... to Review Measure Specifications (@ practice administrator’s labor rate of $105.16/hr.) (m) ................................................. to Review Measure Specifications (@ computer systems analyst’s labor rate of $88.10/hr.) (n) ............................................. to Review Measure Specifications (@ LPN’s labor rate of $43.12/hr.) (o) ................................................................................ to Review Measure Specifications (@ clerk’s labor rate of $36.12/hr.) (p) ............................................................................... to D21Review Measure Specifications (@ physician’s labor rate of $202.08/hr.) (q) ............................................................... $178.36 $214.76 $89.18 $43.96 $36.98 $206.44 Total Cost Per Respondent (r) = (l) + (m) + (n) + (o) + (p) + (q) ................................................................................................ $769.68 Total Annual Cost (s) = (c) * (r) ............................................................................................................................................ $39,916,374 We received no public comments related to the burden estimates for quality performance category: Clinicians using the eCQM collection type. However, the burden estimates have been updated from the CY 2019 PFS proposed rule to reflect availability of data from the 2017 MIPS performance period (83 FR 36025 through 36026). Quality Data Submission via CMS Web Interface: The finalized requirements and burden associated with CMS Web Interface data submission will be submitted to OMB for approval under control number 0938–1314 (CMS–10621). As discussed in section III.I.3.h.(2)(a)(iii)(A)(bb) of this rule, we are finalizing a 33 percent reduction in the number of measures (from 15 to 10 measures) for which clinicians are required to submit quality data via the CMS Web Interface. To account for the decrease in measures, we are also finalizing a decrease to our per respondent time estimate. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 We assume that 286 groups will submit quality data via the CMS Web Interface based on the number of groups who registered for using the CMS Web Interface during the 2018 MIPS performance period. This is a decrease of 10 groups from the currently approved number provided in the CY 2018 Quality Payment Program final rule (82 FR 53915) due to receipt of more current data. We estimate that approximately 91,757 clinicians will submit via this method. The burden associated with the group submission requirements is the time and effort associated with submitting data on a sample of the organization’s beneficiaries that is prepopulated in the CMS Web Interface. In the CY 2018 Quality Payment Program final rule, we estimated that it would take, on average, 74 hours for each group to submit quality measures data via the CMS Web Interface (82 FR 53915). Of those hours, approximately half (or 37 hr) are unaffected by the number of required PO 00000 Frm 00173 Fmt 4701 Sfmt 4700 measures while the other half (37 hr) are affected proportionately by the number of required measures (37 hr × 33 percent reduction = 24.67 hr). Accounting for the finalized reduction in required measures, our revised estimate for the time to submit data via the CMS Web Interface for the 2019 MIPS performance period is 61.67 hours (37 hr + 24.67 hr), a reduction of 12.33 hours or approximately 18 percent of the currently approved 74 hour time estimate. Considering only the time which varies based on the number of required measures, the process of entering or uploading data requires approximately 2.74 hours of a computer systems analyst’s time per measure (24.67 hr/9 measures). Our estimate for submission includes the time needed for each group to populate data fields in the web interface with information on approximately 248 eligible assigned Medicare beneficiaries and submit the data (we will partially pre-populate the CMS Web Interface with claims data E:\FR\FM\23NOR3.SGM 23NOR3 60008 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations from their Medicare Part A and B beneficiaries). The patient data either can be manually entered, uploaded into the CMS Web Interface via a standard file format, which can be populated by CEHRT, or submitted directly. Each group must provide data on 248 eligible assigned Medicare beneficiaries (or all eligible assigned Medicare beneficiaries if the pool of eligible assigned beneficiaries is less than 248) for each measure. In aggregate, we estimate an annual burden of 17,637 hours (286 groups × 61.67 hr) at a cost of $1,572,837 (17,637 hr × $89.18/hr). Independent of the change in the number of respondents, the decrease in total burden resulting from the decrease in required measures is ¥3,650 hours at ¥$325,566 (296 groups × ¥12.33 hr × $89.18/hr). Accounting for the decrease in total time, the decrease in number of respondents results in a total adjustment of ¥616.7 hours at ¥$54,994 (¥10 respondents × 61.67 hr × $89.18/hr). When these adjustments are combined, the net adjustment is ¥4,267 (¥3,650– 617) hours at ¥$380,560 (¥$325,566– $54,994). Based on the assumptions discussed in this section, Table 72 summarizes the burden for groups submitting to MIPS via the CMS Web Interface. TABLE 72—ESTIMATED BURDEN FOR QUALITY DATA SUBMISSION VIA THE CMS WEB INTERFACE amozie on DSK3GDR082PROD with RULES3 Burden estimate Number of Eligible Group Practices (a) .............................................................................................................................................. Total Annual Hours Per Group to Submit (b) .............................................................................................................................. 286 61.67 Total Annual Hours (c) = (a) * (b) ................................................................................................................................................ 17,637 Cost Per Group to Report (@ computer systems analyst’s labor rate of $89.18/hr.) (d) ................................................................... $5,499 Total Annual Cost (e) = (a) * (d) .................................................................................................................................................. $1,572,837 We received no public comments related to the burden estimates for quality data submission via the CMS Web Interface. However, the burden estimates have been updated from the CY 2019 PFS proposed rule to reflect the change in the number of required measures from 9 in the proposed rule to 10 in the final rule (83 FR 36026 through 36027). Beneficiary Responses to CAHPS for MIPS Survey: This rule does not include any new or revised reporting, recordkeeping, or third-party disclosure requirements related to the CAHPS for MIPS survey. However, we have adjusted our currently approved burden estimates based on more recent data. The adjusted burden will be submitted to OMB for approval under control number 0938–1222 (CMS–10450). In this final rule, we have adjusted the number of groups electing to report on the CAHPS for MIPS survey as well as the average number of beneficiaries per group based on more recent data. Under MIPS, groups of 25 or more clinicians can elect to contract with a CMS-approved survey vendor and use the CAHPS for MIPS survey as one of their 6 required quality measures. Beneficiaries that choose to respond to the CAHPS for MIPS survey will experience burden. The usual practice in estimating the burden on public respondents to surveys such as CAHPS is to assume VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 that respondent time is valued, on average, at civilian wage rates. As explained in section V.A. of this final rule, BLS data sets out an average hourly wage for civilians in all occupations at $24.34/hr. Although most Medicare beneficiaries are retired, we believe that their time value is unlikely to depart significantly from prior earnings expense, and we have used the average hourly wage to compute our cost estimate for the beneficiaries’ time. For the 2019 MIPS performance period, we assume that 143 groups will elect to report on the CAHPS for MIPS survey, which is equal to the number of groups that have registered and have a sufficient beneficiary sample size to conduct the CAHPS for MIPS survey in the 2018 MIPS performance period; a decrease of 318 from the 461 groups currently approved by OMB. Table 73 shows the estimated annual burden for beneficiaries to participate in the CAHPS for MIPS Survey. Based on the number of complete and partially complete surveys for groups participating in CAHPS for MIPS survey administration for the 2018 MIPS performance period, we assume that an average of 273 beneficiaries will respond per group for the 2019 MIPS performance period. Therefore, the CAHPS for MIPS survey will be administered to approximately 39,039 PO 00000 Frm 00174 Fmt 4701 Sfmt 4700 beneficiaries per year (143 groups × an average of 273 beneficiaries per group responding). This is a decrease of 93,268 from our currently approved 132,307 beneficiary estimate. The CAHPS for MIPS survey that will be administered in the 2019 MIPS performance period is unchanged from the survey administered in the 2018 MIPS performance period. In that regard, we continue to estimate an average administration time of 12.9 minutes (or 0.215 hr) at a pace of 4.5 items per minute for the English version of the survey. For the Spanish version, we estimate an average administration time of 15.5 minutes (assuming 20 percent more words in the Spanish translation). However, since less than 1 percent of surveys were administered in Spanish for reporting year 2016, our burden estimate reflects the time for administering the English version of the survey. Given that we expect approximately 39,039 respondents, we estimate an annual burden of 8,393 hours (39,039 respondents × 0.215 hr/respondent) at a cost of $204,286 (8,393 hr × $24.34/hr). The decrease in the number of beneficiaries responding to the CAHPS for MIPS survey results in an adjustment to the total time burden of ¥20,715 hours and ¥$503,556 (¥93,268 beneficiaries × 0.215 hr × $24.34/hr). E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60009 TABLE 73—ESTIMATED BURDEN FOR BENEFICIARY PARTICIPATION IN CAHPS FOR MIPS SURVEY Burden estimate Number of Eligible Group Practices Administering CAHPS for MIPS (a) .......................................................................................... Number of Beneficiaries Per Group Responding to Survey (b) .......................................................................................................... Number of Total Beneficiary Respondents (c) = (a) * (b) ................................................................................................................... Number of Hours Per Beneficiary Respondent (d) ............................................................................................................................. Cost (@ labor rate of $24.34/hr.) (e) .................................................................................................................................................. 143 273 39,039 0.215 $24.34/hr Total Annual Hours (f) = (c) * (d) ................................................................................................................................................. 8,393 Total Annual Cost for Beneficiaries Responding to CAHPS for MIPS (g) = (c) * (e) .......................................................... $204,286 We received no public comments related to the burden estimates for beneficiary participation in CAHPS for MIPS survey. However, the burden estimates have been updated from the CY 2019 PFS proposed rule to reflect availability of data from the 2018 MIPS performance period (83 FR 36027). Group Registration for CMS Web Interface: This rule does not include any new or revised reporting, recordkeeping, or third-party disclosure requirements related to the group registration for CMS Web Interface. However, we have adjusted our currently approved burden estimates based on more recent data. The adjusted burden will be submitted to OMB for approval under control number 0938–1222 (CMS–10450). In this final rule, we have adjusted the number of respondents based on more recent data and adjusted our per response time estimate based on our review of the currently approved estimates against the existing registration process. Groups interested in participating in MIPS using the CMS Web Interface for the first time must complete an on-line registration process. After first time registration, groups will only need to opt out if they are not going to continue to submit via the CMS Web Interface. In Table 74, we estimate that the registration process for groups under MIPS involves approximately 0.25 hours at $89.18/hr for a computer systems analyst (or their equivalent) to register the group. Although the registration process remains unchanged from the CY 2018 Quality Payment Program final rule, a review of the steps required for registration warranted a reduction of 0.75 hours in estimated burden per group (82 FR 53917). We assume that approximately 67 groups will elect to use the CMS Web Interface for the first time during the 2019 MIPS performance period based on the number of new registrations received during the CY 2018 registration period; an increase of 57 compared to the number of groups currently approved by OMB under control number 0938–1314 (CMS–10621). In aggregate, we estimate a burden of 16.75 hours (67 new registrations × 0.25 hr/ registration) at a cost of $1,494 (16.75 hr × $89.18/hr). Independent of the decrease in time burden per group, the increase in the number of groups registering to submit MIPS data via the CMS Web Interface results in an adjustment to the total time burden of 57 hours at $5,083 (57 groups × 1 hr × $89.18/hr). Accounting for the increase in the number of groups, the decrease in time burden per group to register results in an adjustment to the total burden of ¥50.25 hours at ¥$4,481 (67 groups × ¥0.75 hrs × $89.18/hr). When these adjustments are combined, the net adjustment is 6.75 hours (57¥50.25) at $602 ($5,083¥$4,481). TABLE 74—ESTIMATED BURDEN FOR GROUP REGISTRATION FOR CMS WEB INTERFACE amozie on DSK3GDR082PROD with RULES3 Burden estimate Number of New Groups Registering for CMS Web Interface (a) ....................................................................................................... Annual Hours Per Group (b) ............................................................................................................................................................... 67 0.25 Total Annual Hours (c) = (a) * (b) ................................................................................................................................................ 16.75 Labor Rate to Register for CMS Web Interface @ computer systems analyst’s labor rate) (d) ........................................................ $89.18/hr Total Annual Cost for CMS Web Interface Group Registration (e) = (a) * (d) ............................................................................ $1,494 We received no public comments related to the burden estimates for group registration for the CMS Web Interface. The burden estimates have not been updated from the CY 2019 PFS proposed rule (83 FR 36027 through 36028). Group Registration for CAHPS for MIPS Survey: This rule does not include any new or revised reporting, recordkeeping, or third-party disclosure requirements related to the group registration for the CAHPS for MIPS VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 Survey. However, we have adjusted our currently approved burden estimates based on more recent data. The adjusted burden will be submitted to OMB for approval under control number 0938– 1222 (CMS–10450). In this final rule, we have adjusted our currently approved number of respondents based on more recent data and adjusted our per respondent time estimate based on our review of the current burden estimates against the existing registration process. PO 00000 Frm 00175 Fmt 4701 Sfmt 4700 Under MIPS, the CAHPS for MIPS survey counts for 1 measure toward the MIPS quality performance category and, as a patient experience measure, it also fulfills the requirement to submit at least one high priority measure in the absence of an applicable outcome measure. Groups that wish to administer the CAHPS for MIPS survey must register by June of the applicable 12month performance period, and electronically notify CMS of which vendor they have selected to administer E:\FR\FM\23NOR3.SGM 23NOR3 60010 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations the survey on their behalf. For the 2019 MIPS performance period, we assume that 282 groups will enroll in the MIPS for CAHPS survey based on the number of groups which elected to register during the CY 2018 registration period; a decrease of 179 compared to the number of groups currently approved by OMB under the aforementioned control number (82 FR 53917). As shown in Table 75, we assume that the staff involved in the group registration for CAHPS for MIPS Survey will mainly be computer systems analysts (or their equivalent) who have an average labor cost of $89.18/hr. We assume the CAHPS for MIPS Survey registration burden consists of 0.25 hours to register for the survey as well as 0.5 hours to select the CAHPS for MIPS Survey vendor that will be used and electronically notifying CMS of this selection. In this regard, the total time for CAHPS for MIPS registration is 0.75 hours. Although the registration process remains unchanged from the CY 2018 Quality Payment Program final rule, after we reviewed the steps required for registration more thoroughly, we believe that the burden was less than we had originally estimated. Therefore, we have adjusted the estimated burden from 1.5 hours to 0.75 hours per respondent. In aggregate, we estimate an annual burden of 211.50 hours (282 groups × 0.75 hr per group) at a cost of $18,862 (211.50 hr × $89.18/hr). Independent of the change in time per group, the decrease in the number of groups registering results is an adjustment to the total burden of ¥268.5 hours at ¥$23,945 (¥179 groups × 1.5 hrs × $89.18/hr). Accounting for the decrease in the number of groups registering, the decrease in time per group to register results in an adjustment to the total burden of ¥211.5 hours at ¥$18,862 (282 groups × ¥0.75 hr × $89.18/hr). When these adjustments are combined, the net adjustment is ¥480 hours (¥268.5¥211.5) at ¥$42,807 (¥$23,945¥$18,862). TABLE 75—ESTIMATED BURDEN FOR GROUP REGISTRATION FOR CAHPS FOR MIPS SURVEY Burden estimate # of Groups Registering for CAHPS (a) .............................................................................................................................................. Total Annual Hours for CAHPS Registration (b) ................................................................................................................................. 282 0.75 Total Annual Hours for CAHPS Registration (c) = (a) * (b) ......................................................................................................... 211.5 Labor Rate to Register for CAHPS (computer systems analyst) (d) .................................................................................................. $89.18/hr Total Annual Cost for CAHPS Registration (e) = (a) * (d) ........................................................................................................... $18,862 amozie on DSK3GDR082PROD with RULES3 We received no public comments related to the burden estimates for group registration for the CAHPS for MIPS survey. However, the burden estimates have been updated from the CY 2019 PFS proposed rule to reflect availability of data from the 2018 MIPS performance period (83 FR 36028 through 36029). 9. Quality Payment Program ICRs Regarding the Nomination of Quality Measures This rule does not include any new or revised reporting, recordkeeping, or third-party disclosure requirements related to the nomination of quality measures. However, we have adjusted our currently approved burden estimates based on more recent data. We have also accounted for burden associated with policies that have been finalized but whose burden were erroneously excluded from our estimates. The new and adjusted burden will be submitted to OMB for approval under control number 0938–1314 (CMS–10621). As discussed in section III.I.3.h.(2)(b)(i) of this final rule, quality measures are selected annually through a call for quality measures under consideration, with a final list of quality measures being published in the Federal Register by November 1 of each year. Under section 1848(q)(2)(D)(ii) of the Act, the Secretary must solicit a VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 ‘‘Call for Quality Measures’’ each year. Specifically, the Secretary must request that eligible clinician organizations and other relevant stakeholders identify and submit quality measures to be considered for selection in the annual list of MIPS quality measures, as well as updates to the measures. Under section 1848(q)(2)(D)(ii) of the Act, eligible clinician organizations are professional organizations as defined by nationally recognized specialty boards of certification or equivalent certification boards. As we described in the CY 2017 Quality Payment Program final rule (81 FR 77137), we will accept quality measures submissions at any time, but only measures submitted during the timeframe provided by us through the pre-rulemaking process of each year will be considered for inclusion in the annual list of MIPS quality measures for the performance period beginning 2 years after the measure is submitted. This process is consistent with the prerulemaking process and the annual call for measures, which are further described at https://www.cms.gov/ Medicare/Quality-Initiatives-PatientAssessment-Instruments/ QualityMeasures/Pre-Rule-Making.html. To identify and submit a quality measure, eligible clinician organizations and other relevant stakeholders use a one-page online form that requests PO 00000 Frm 00176 Fmt 4701 Sfmt 4700 information on background, a gap analysis which includes evidence for the measure, reliability, validity, endorsement and a summary which includes how the proposed measure relates to the Quality Payment Program and the rationale for the measure. In addition, proposed measures must be accompanied by a completed Peer Review Journal Article form. As shown in Table 76, we estimate that approximately 140 organizations, including clinicians, CEHRT developers, and vendors, will submit measures for the Call for Quality Measures process; an increase of 100 compared to the number of organizations currently approved by OMB. In keeping with the focus on clinicians as the primary source for recommending new quality measures, we are using practice administrators and clinician time for our burden estimates. We also estimate it will take 0.5 hours per organization to submit an activity to us, consisting of 0.3 hours at $107.38/ hr for a practice administrator to make a strategic decision to nominate and submit a measure and 0.2 hours at $206.44/hr for clinician review time. The 0.5 hour estimate assumes that submitters will have the necessary information to complete the nomination form readily available, which we believe is a reasonable assumption. Additionally, some submitters familiar E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations with the process or who are submitting multiple measures may require significantly less time, while other submitters may require more if the opposite is true; on average we believe 0.5 hours is a reasonable average across all submitters. Consistent with the CY 2017 Quality Payment Program final rule, we also estimate it will take 4 hours at $206.44/ hr for a clinician (or equivalent) to complete the Peer Review Journal Article Form (81 FR 77153 through 77155). This assumes that measure information is available and testing is complete in order to have the necessary information to complete the form, which we believe is a reasonable assumption. Although the requirement for completing the Peer Review Journal Article was previously included in the CY 2017 Quality Payment Program final rule, the time required for completing the form was erroneously excluded from our burden estimates. As shown in Table 76, in aggregate we estimate an annual burden of 630 hours (140 organizations × 4.5 hr/response) at a cost of $125,896 (140 × [(0.3 hr × $107.38/hr) + (4.2 hr × $206.44/hr)]. 60011 Independent of the change in time per organization, the change in the number of organizations nominating new quality measures results in an adjustment of 50 hours at $7,350 (100 organizations × [(0.3 hr × $107.38/hr) + (0.2 hr x $206.44/hr)]). When accounting for the change in respondents, the change in burden to nominate a quality measure results in an adjustment of 560 hours at $115,606 (140 organizations × 4 hr × $206.44/hr). When these adjustments are combined, the total adjustment is 610 hours (560 + 50) at $122,956 ($7,350 + $115,606). TABLE 76—ESTIMATED BURDEN FOR CALL FOR QUALITY MEASURES Burden estimate # of Organizations Nominating New Quality Measures (a) ................................................................................................................. # of Hours Per Practice Administrator to Identify and Propose Measure (b) ..................................................................................... # of Hours Per Clinician to Identify Measure (c) ................................................................................................................................. # of Hours Per Clinician to Complete Peer Review Article Form (d) ................................................................................................. Annual Hours Per Response (e) = (b) + (c) + (d) ............................................................................................................................... 140 0.30 0.20 4.00 4.50 Total Annual Hours (f) = (a) * (e) .......................................................................................................................................... 630 Cost to Identify and Submit Measure (@ practice administrator’s labor rate of $107.38/hr.) (g) ...................................................... Cost to Identify Quality Measure and Complete Peer Review Article Form (@ physician’s labor rate of $206.44/hr.) (h) ............... $32.21 $867.05 Total Annual Cost Per Respondent (i) = (g) + (h) ................................................................................................................ $899.26 Total Annual Cost (j) = (a) * (i) ............................................................................................................................................. $125,896 We received no public comments related to the burden estimates for the Call for Quality Measures. The burden estimates have not been updated from the CY 2019 PFS proposed rule (83 FR 36029 through 36030). amozie on DSK3GDR082PROD with RULES3 10. Quality Payment Program ICRs Regarding Promoting Interoperability Data (§§ 414.1375 and 414.1380) The finalized requirements and burden discussed under this section will be submitted to OMB for approval under control number 0938–1314 (CMS–10621). For the 2019 MIPS performance period, clinicians and groups can submit Promoting Interoperability data through direct, log in and upload, or log in and attest submission types. We have worked to further align the Promoting Interoperability performance category with other MIPS performance categories. With the exception of submitters who elect to use the log in and attest submission type for the Promoting Interoperability performance category which is not available for the quality performance category, we anticipate that most organizations will use the same data submission type for the both of these performance categories and that the clinicians, practice VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 managers, and computer systems analysts involved in supporting the quality data submission will also support the Promoting Interoperability data submission process. Hence, the following burden estimates show only incremental hours required above and beyond the time already accounted for in the quality data submission process. Although this analysis assesses burden by performance category and submission type, we emphasize that MIPS is a consolidated program and submission analysis and decisions are expected to be made for the program as a whole. Reweighting Applications for Promoting Interoperability and Other Performance Categories: As established in the CY 2017 and CY 2018 Quality Payment Program final rules, MIPS eligible clinicians who meet the criteria for a significant hardship or other type of exception may submit an application requesting a zero percent weighting for the Promoting Interoperability performance category in the following circumstances: insufficient internet connectivity, extreme and uncontrollable circumstances, lack of control over the availability of CEHRT, clinicians who are in a small practice, and decertified EHR technology (81 FR PO 00000 Frm 00177 Fmt 4701 Sfmt 4700 77240 through 77243 and 82 FR 53680 through 53686). In addition, as finalized in the CY 2018 Quality Payment Program final rule, MIPS eligible clinicians and groups citing extreme and uncontrollable circumstances may also apply for a reweighting of the quality, cost, and/or improvement activities performance categories (82 FR 53783 through 53785). Respondents who apply for a reweighting for any of these performance categories have the option of applying for reweighting for the Promoting Interoperability performance category on the same online form. Since we do not have data on the number of reweighting applications submitted for the 2018 MIPS performance period for this rule, we assume that respondents applying for a reweighting of the Promoting Interoperability performance category due to extreme and uncontrollable circumstances will also request a reweighting of at least one of the other performance categories simultaneously and not submit multiple reweighting applications. As data availability allows, we will estimate the reporting burden for each reweighting application under separate ICRs in future rulemaking. Table 77 summarizes the burden for clinicians to apply for reweighting the E:\FR\FM\23NOR3.SGM 23NOR3 60012 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations Promoting Interoperability performance category to zero percent due to a significant hardship exception (including a significant hardship exception for small practices) or as a result of a decertification of an EHR. Based on the number of reweighting applications received for the 2017 MIPS performance period, we assume 6,041 respondents (eligible clinicians or groups) will submit a request to reweight the Promoting Interoperability performance category to zero percent due to a significant hardship (including clinicians in small practices) or EHR decertification. We estimate that 3,344 respondents (eligible clinicians or groups) will submit a request for reweighting the Promoting Interoperability performance category to zero percent due to extreme and uncontrollable circumstances, insufficient internet connectivity, lack of control over the availability of CEHRT, or as a result of a decertification of an EHR. An additional 2,697 respondents will submit a request for reweighting the Promoting Interoperability performance category to zero percent as a small practice experiencing a significant hardship. In total, this represents a decrease of 34,604 from the number of respondents currently approved by OMB. In the CY 2019 PFS proposed rule, we lacked the detailed data necessary to independently estimate the number of reweighting applications submitted by clinicians in a small practice who were of an eligible clinician type and are not eligible to have the Promoting Interoperability performance category reweighted for any other reason (for example, because they are hospitalbased, ASC-based, or non-patient facing), and therefore, assumed all clinicians in small practices that met these criteria would apply for reweighting of the Promoting Interoperability performance category. Data from the 2017 MIPS performance period has sufficient detail to allow for this analysis, resulting in a decrease of 78,573 from the estimate of 81,270 clinicians in a small practice cited in the CY 2019 PFS proposed rule (83 FR 36030). The total of 6,041 respondents represents a decrease of 34,604 from the number of respondents currently approved by OMB. The application to request a reweighting to zero percent only for the Promoting Interoperability performance category is a short online form that requires identifying the type of hardship experienced or whether decertification of an EHR has occurred and a description of how the circumstances impair the clinician or group’s ability to submit Promoting Interoperability data, as well as some proof of circumstances beyond the clinician’s control. The application for reweighting of the quality, cost, Promoting Interoperability, and/or improvement activities performance categories due to extreme and uncontrollable circumstances requires the same information with the exception of there being only one option for the type of hardship experienced. We estimate it will take 0.25 hours at $89.18/hr for a computer system analyst to submit the application. This is a reduction from the 0.5 hours estimated in the CY 2018 Quality Payment Program final rule due to a revised assessment of the application process (82 FR 53918). As shown in Table 77, in aggregate, we estimate an annual burden of 1,510.25 hours (6,041 applications × 0.25 hr/application) at a cost of $134,684 (1,510.25 hr × $89.18/ hr). Independent of the change to the number of respondents, the decrease in the amount of time to submit a reweighting application results in an adjustment of ¥10,161.25 hours at ¥$906,180 (40,645 respondents × ¥0.25 hr × $89.18/hr). Accounting for the decrease in time per respondent, the decrease in the number of respondents submitting reweighting applications results in an adjustment of ¥8,651 hours at ¥$771,496 (¥34,604 respondents × 0.25 hr × $89.18hr). When these adjustments are combined, the total adjustment is ¥18,812.25 hours (¥10,161.25¥8,651) at $1,677,676 (¥$906,180¥$771,496). TABLE 77—ESTIMATED BURDEN FOR REWEIGHTING APPLICATIONS FOR PROMOTING INTEROPERABILITY AND OTHER PERFORMANCE CATEGORIES amozie on DSK3GDR082PROD with RULES3 Burden estimate # of Eligible Clinicians or Groups Applying Due to Significant Hardship and Other Exceptions (a) .................................................. # of Eligible Clinicians or Groups Applying Due to Significant Hardship for Small Practice (b) ........................................................ 3,344 2,697 Total Respondents Due to Hardships, Other Exceptions and Hardships for Small Practices (c) .............................................. 6,041 Hours Per Applicant per application submission (d) ........................................................................................................................... 0.25 Total Annual Hours (e) = (a) * (c) ................................................................................................................................................ Labor Rate for a computer systems analyst (f) ................................................................................................................................... 1,510.25 $89.18/hr Total Annual Cost (g) = (a) * (f) ................................................................................................................................................... $134,684 The following is a summary of the public comments received on the Quality Payment Program ICRs regarding reweighting applications for Promoting Interoperability and other performance categories: Comment: One commenter noted that CMS’s estimate of 15 minutes to complete and submit the Promoting Interoperability reweighting application is low and should be increased to an estimate of between 30 minutes and 1 hour. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 Response: We understand that some respondents may require additional time to submit a reweighting application above the 15 minutes we estimate, but we believe this estimate is a reasonable average across all respondents as the application process requires limited basic information about the clinician or submitter, a small number of check boxes and drop-down selections, and a free text field to provide justification for the requested application. In addition, PO 00000 Frm 00178 Fmt 4701 Sfmt 4700 we believe increased familiarity with the process in its second year also reduces the average time across all respondents. After consideration of public comments, we are making no changes to our estimates as a result of public comments received. However, the burden estimates have been updated from the CY 2019 PFS proposed rule to reflect availability of data from the 2017 MIPS performance period (83 FR 36030 through 36031). E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations Submitting Promoting Interoperability Data: In this final rule, we have adjusted the estimated number of respondents based on data from the 2017 MIPS performance period and the estimated per respondent time due to the net reduction of 3 measures (6 removed measures and 3 new measures) for which clinicians are required to submit data, which we are finalizing as discussed in section III.I.3.h.(5)(f) of this final rule. A variety of organizations will submit Promoting Interoperability data on behalf of clinicians. Clinicians not participating in a MIPS APM may submit data as individuals or as part of a group. In the CY 2017 Quality Payment Program final rule (81 FR 77258 through 77260, 77262 through 77264), we established that eligible clinicians in MIPS APMS other than the Shared Savings Program may submit data for the Promoting Interoperability performance category as individuals or as part of a group, whereas eligible clinicians participating in the Shared Savings Program are limited to submitting data through the ACO participant TIN. In section III.I.3.h.(6)(d)(ii) of this final rule, we are finalizing our proposal to extend this flexibility to allow for both individual and group reporting by eligible clinicians participating in the Shared Savings Program. As shown in Table 78, based on data from the 2017 MIPS performance period, we estimate that a total of 93,933 respondents consisting of 81,456 individual MIPS eligible clinicians and 12,413 groups will submit Promoting Interoperability data. Similar to the process shown in Table 66 for groups reporting via QCDR/MIPS CQM and eCQM collection types, we have adjusted the group reporting data from the 2017 MIPS performance period to account for virtual groups, as the option to submit data as a virtual group was not available until the 2018 MIPS performance period. These estimates reflect that under the policies in the CY 2017 Quality Payment Program final rule and in the CY 2018 Quality Payment Program final rule, certain MIPS eligible clinicians will be eligible for automatic reweighting of the Promoting Interoperability performance category to zero percent, including MIPS eligible clinicians that are hospital-based, ambulatory surgical center-based, non-patient facing clinicians, physician assistants, nurse practitioners, clinician nurse specialists, and certified registered nurse anesthetists (81 FR 77238 through 77245 and 82 FR 53680 through 53687). As discussed in section III.I.3.h.(5)(h)(ii) of this final rule, starting with the 2021 MIPS payment year, we are finalizing a policy to automatically reweight the Promoting Interoperability performance 60013 category for clinician types new to MIPS: Physical therapists; occupational therapists; qualified speech-language pathologists or qualified audiologist; clinical psychologists; and registered dieticians or nutrition professionals. These estimates also account for the reweighting policies finalized in the CY 2017 and CY 2018 Quality Payment Program final rules, including exceptions for MIPS eligible clinicians who have experienced a significant hardship (including clinicians who are in small practices), as well as exceptions due to decertification of an EHR. Further, we assume that Shared Savings Program Track 1 ACOs will submit data at the ACO participant TINlevel, APM Entities electing the onesided track in the CEC model will submit data at the group TIN-level, and APM Entities in the OCM (one-sided risk arrangement) will submit data at APM Entity level; these entities are included in our estimate of the number of groups submitting data. Our respondent estimate is based on existing data and does not consider policies finalized in section V of this final rule, as well as additional policies that were proposed in the August 2018 proposed rule and may be finalized in a future rule, which may change the number of Shared Saving Program ACOs that are required to submit Promoting Interoperability data for future years.45 TABLE 78—ESTIMATED NUMBER OF RESPONDENTS TO SUBMIT PROMOTING INTEROPERABILITY PERFORMANCE DATA ON BEHALF OF CLINICIANS amozie on DSK3GDR082PROD with RULES3 Number of respondents Number of individual clinicians to submit Promoting Interoperability (a) ............................................................................................ Number of groups to submit Promoting Interoperability(b) ................................................................................................................. Subtract: Number of groups to submit Promoting Interoperability on behalf of clinicians in Quality Payment Program Year 3 that will submit as virtual groups in Quality Payment Program Year 3 (c) ............................................................................................ Add in: Number of virtual groups to submit Promoting Interoperability on behalf of clinicians in Quality Payment Program Year 3 (d) ..................................................................................................................................................................................................... Number of groups to submit Promoting Interoperability on behalf of clinicians in Quality Payment Program Year 3 (e) = (b)¥(c) + (d) .................................................................................................................................................................................................. 81,456 12,477 Total (f) = (a) + (e) ....................................................................................................................................................................... 93,869 In the CY 2018 Quality Payment Program final rule, we estimated it takes 3 hours for a computer system analyst to collect and submit Promoting Interoperability performance category data (82 FR 53920). For this final rule, we estimate the time required to submit such data should be reduced by 20 minutes to 2.67 hours due to the reduction in the number of measures for which clinicians are required to submit data, which we are finalizing as discussed in section III.I.3.h.(5)(f) of this final rule. As shown in Table 78, the total time for an organization to submit data on the specified Promoting Interoperability objectives and measures is estimated to be 250,317 hours (93,869 respondents × 2.67 incremental hours for a computer analyst’s time above and beyond the clinician, practice manager, and computer system’s analyst time 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00179 Fmt 4701 Sfmt 4700 16 12,413 required to submit quality data) at a cost of $22,323,300 (250,317 hr × $89.18/hr). Independent of the change in the number of respondents, the reduction in estimated time to submit Promoting Interoperability data results in a decrease in burden of ¥72,738.33 hours at ¥$6,486,805 (218,215 respondents × ¥0.33 hr × $89.18/hr). Accounting for the decreased per respondent time, the decrease in the number of respondents 45 https://www.gpo.gov/fdsys/pkg/FR-2018-08-17/ pdf/2018-17101.pdf. VerDate Sep<11>2014 80 E:\FR\FM\23NOR3.SGM 23NOR3 60014 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations results in an adjustment to the total burden of ¥331,589.33 hours at ¥$29,571,137 (¥124,346 respondents × 2.67 hrs × $89.18/hr). When these adjustments are combined, the total adjustment is ¥404,327.67 hours (¥72,738.33 ¥331,589.33) at ¥$36,057,941 (¥$6,486,805 ¥$29,571,137). TABLE 79—ESTIMATED BURDEN FOR PROMOTING INTEROPERABILITY PERFORMANCE CATEGORY DATA SUBMISSION Burden estimate Number of individual clinicians to submit Promoting Interoperability (a) ............................................................................................ Number of groups to submit Promoting Interoperability (b) ................................................................................................................ 81,456 12,413 Total (c) = (a) + (b) ....................................................................................................................................................................... 93,869 Total Annual Hours Per Respondent (b) ...................................................................................................................................... 2.67 Total Annual Hours (c) = (a) * (b) ....................................................................................................................................................... 250,317 Labor rate for a computer systems analyst to submit Promoting Interoperability data/hr.) (d) .......................................................... $89.18/hr Total Annual Cost (e) = (a) * (d) .................................................................................................................................................. $22,323,300 amozie on DSK3GDR082PROD with RULES3 The following is a summary of the public comments received on the Quality Payment Program ICRs regarding Promoting Interoperability Data: Comment: One commenter noted that CMS should consider and reduce the operational burden imposed on clinicians and medical practice staff by the required measures and reporting processes associated with the Quality Payment Program specifically and all quality reporting programs in general. The commenter cited the 20 minute reduction in burden associated with the proposed reduction in Promoting Interoperability measures as evidence of its belief that reducing the number of measures is not enough to reduce the total burden on respondents. The commenter also noted its belief that frustration and clinician burnout are increased due to the documentation requirements and workflow modifications associated with quality reporting programs. Response: We thank the commenter for its input. We recognize there is additional burden on clinicians and practice staff beyond the reporting burden estimated in the Collection of Information section of this policy which only accounts for the time required for record keeping, reporting, and thirdparty disclosures associated with the policy. CMS does consider the operational burden imposed on clinicians and practice staff and weighs it against the goal of improving quality of care prior to finalizing policy decisions. On balance, we believe that any potential additional burden is outweighed by increased quality and improved patient outcomes. We will continue to monitor this balance and will continue to propose efficiencies and policies that will help to further reduce burden. After consideration of public comments, we are making no changes to our estimates as a result of public comments received. However, the burden estimates have been updated from the CY 2019 PFS proposed rule to reflect availability of data from the 2017 MIPS performance period (83 FR 36031 through 36032). 11. Quality Payment Program ICRs Regarding the Nomination of Promoting Interoperability (PI) Measures This rule does not include any new or revised reporting, recordkeeping, or third-party disclosure requirements related to the nomination of Promoting Interoperability measures. However, we have adjusted our currently approved burden estimates based data from the 2017 MIPS performance period. The adjusted burden will be submitted to OMB for approval under control number 0938–1314 (CMS–10621). Consistent with our requests for stakeholder input on quality measures and improvement activities, we also request potential measures for the Promoting Interoperability performance category that measure patient outcomes, emphasize patient safety, support improvement activities and the quality performance category, and build on the advanced use of CEHRT using 2015 Edition standards and certification criteria. Promoting Interoperability measures may be submitted via a designated submission form that includes the measure description, measure type (if applicable), reporting requirement, and CEHRT functionality used (if applicable). We estimate 47 organizations will submit Promoting Interoperability measures, based on the number of organizations submitting measures during the CY 2017 nomination period. This is an increase of 7 from the estimate currently approved by OMB under the aforementioned control number. We estimate it will take 0.5 hours per organization to submit an activity to us, consisting of 0.3 hours at $107.38/hr for a practice administrator to make a strategic decision to nominate that activity and submit an activity to us via email and 0.2 hours at $206.44/hr for a clinician to review the nomination. As shown in Table 80, in aggregate, we estimate an annual burden of 235 hours (47 organizations × 0.5 hr/response) at a cost of $3,455 (47 × [(0.3 h × $107.38/ hr) + (0.2 hr × $206.44/hr)]. The increase in the number of respondents results in an adjustment of 3.5 hours and $514.50 (7 respondents × 0.5 hrs × $73.50 per respondent). TABLE 80—ESTIMATED BURDEN FOR CALL FOR PROMOTING INTEROPERABILITY MEASURES Burden estimate # of Organizations Nominating New Promoting Interoperability Measures (a) ................................................................................... # of Hours Per Practice Administrator to Identify and Propose Measure (b) ..................................................................................... # of Hours Per Clinician to Identify Measure (c) ................................................................................................................................. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00180 Fmt 4701 Sfmt 4700 E:\FR\FM\23NOR3.SGM 23NOR3 47 0.30 0.20 60015 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations TABLE 80—ESTIMATED BURDEN FOR CALL FOR PROMOTING INTEROPERABILITY MEASURES—Continued Burden estimate Annual Hours Per Respondent (d) = (b) + (c) .................................................................................................................................... 0.50 Total Annual Hours (e) = (a) * (d) ................................................................................................................................................ 23.50 Cost to Identify and Submit Measure (@practice administrator’s labor rate of $107.38/hr.) (f) ......................................................... Cost to Identify Improvement Measure (@physician’s labor rate of $206.44/hr.) (g) ......................................................................... $32.21 $41.29 Total Annual Cost Per Respondent (h) = (f) + (g) ....................................................................................................................... Total Annual Cost (i) = (a) * (h) ................................................................................................................................................... $73.50 $3,455 We received no public comments related to the burden estimates for the Call for Promoting Interoperability Measures. The burden estimates have not been updated from the CY 2019 PFS proposed rule (83 FR 36032 through 36033). 12. Quality Payment Program ICRs Regarding Improvement Activities Submission (§§ 414.1305, 414.1355, 414.1360, and 414.1365) amozie on DSK3GDR082PROD with RULES3 This rule does not include any new or revised reporting, recordkeeping, or third-party disclosure requirements related to the submission of Improvement Activities data. However, we have adjusted our currently approved burden estimates based on more recent data. The adjusted burden will be submitted to OMB for approval under control number 0938–1314 (CMS–10621). We refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77511 through 77512) and the CY 2018 Quality Payment Program final rule (82 FR 53920 through 53922) for our previous burden estimates for improvement activities under the Quality Payment Program. The CY 2018 Quality Payment Program final rule provides: (1) That for activities that are performed for at least a continuous 90 days during the performance period, MIPS eligible clinicians must submit a ‘‘yes’’ response for activities within the Improvement Activities Inventory (82 FR 53651); (2) that the term ‘‘recognized’’ is accepted as equivalent to the term ‘‘certified’’ when referring to the requirements for a patient-centered medical home to VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 receive full credit for the improvement activities performance category for MIPS (82 FR 53649); and (3) that for the 2020 MIPS payment year and future years, to receive full credit as a certified or recognized patient-centered medical home or comparable specialty practice, at least 50 percent of the practice sites within the TIN must be recognized as a patient-centered medical home or comparable specialty practice (82 FR 53655). In the CY 2017 Quality Payment Program final rule, we describe how we determine MIPS APM scores (81 FR 77185). We compare the requirements of the specific MIPS APM with the list of activities in the Improvement Activities Inventory and score those activities in the same manner that they are otherwise scored for MIPS eligible clinicians (81 FR 77817 through 77831). If, by our assessment, the MIPS APM does not receive the maximum improvement activities performance category score, then the APM Entity can submit additional improvement activities, although, as we noted, we anticipate that MIPS APMs in the 2019 MIPS performance period will not need to submit additional improvement activities as the models will already meet the maximum improvement activities performance category score (81 FR 77185). A variety of organizations and in some cases, individual clinicians, will submit improvement activity performance category data. For clinicians who are not part of APMs, we assume that clinicians submitting quality data as part of a group through direct, log in and upload submission PO 00000 Frm 00181 Fmt 4701 Sfmt 4700 types, and CMS Web Interface will also submit improvement activities data. As finalized in the CY 2017 Quality Payment Program final rule (81 FR 77264), APM Entities only need to report improvement activities data if the CMS-assigned improvement activities score is below the maximum improvement activities score. Our CY 2018 Quality Payment Program final rule burden estimates assumed that all APM Entities will receive the maximum CMS-assigned improvement activities score (82 FR 53921 through 53922). As represented in Table 81, based on 2017 MIPS performance period data, we estimate that 125,713 clinicians will submit improvement activities as individuals during the 2019 MIPS performance period and 16,478 groups will submit improvement activities on behalf of clinicians. Similar to the process shown in Table 77 for groups submitting Promoting Interoperability data, we have adjusted the group reporting data from the 2017 MIPS performance period to account for virtual groups, as the option to submit data as a virtual group was not available until the 2018 MIPS performance period. Our burden estimates assume there will be no improvement activities burden for MIPS APM participants. We will assign the improvement activities performance category score at the APM level. We also assume that the MIPS APM models for the 2019 MIPS performance period will qualify for the maximum improvement activities performance category score and the APM Entities will not need to submit any additional improvement activities. E:\FR\FM\23NOR3.SGM 23NOR3 60016 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations As described in section III.I.3.h.(4)(b) of this final rule, for purposes of the 2021 MIPS payment year, we have finalized § 414.1360(a)(1) to more accurately reflect the data submission process for the improvement activities performance category. In particular, instead of ‘‘via qualified registries; EHR submission mechanisms; QCDR, CMS Web Interface; or attestation,’’ as currently stated, we have revised the first sentence to state that data will be submitted ‘‘via direct, log in and upload, and log in and attest.’’ The revision will more closely align with the actual submission experience users have. In the CY 2018 Quality Payment Program final rule, we estimated it would take 1 hour for a computer system analyst to submit data on the specified improvement activities (82 FR 53922). We are finalizing to decrease this burden estimate since the actual submission experience of the user is such that improvement activities data is submitted as part of the process for submitting quality and Promoting Interoperability data, resulting in less additional required time to submit improvement activities data. As a result, we estimate that the per response time required per individual or group is 5 minutes at $89.18/hr for a computer system analyst to submit by logging in and manually attesting that certain activities were performed in the form and manner specified by CMS with a set of authenticated credentials. Additionally, as stated in the CY 2018 Quality Payment Program final rule, the same improvement activity may be reported across multiple performance periods so many MIPS eligible clinicians will not have any additional information to submit for the 2019 MIPS performance period (82 FR 53921). As discussed in section III.I.3.h.(4)(d)(ii) of this final rule, we are also finalizing for CY 2019 and future years to: Add 6 new improvement activities; modify 5 existing improvement activities; and remove 1 existing improvement activity. Because MIPS eligible clinicians are still required to submit the same number of activities, we do not expect these provisions to affect our collection of information burden estimates. In addition, in order for an eligible clinician or group to receive credit for being a patient-centered medical home or comparable specialty practice, the eligible clinician or group must attest in the same manner as any other improvement activity. As shown in Table 82, we estimate an annual burden of 11,333.7 hours (136,004 responses × 5 minutes/60) at a cost of $1,010,736 (11,333.7 hr × $89.18/ hr). Independent of the change to our per response time estimate, the decrease in the number of respondents results in an adjustment of ¥303,782 hours at ¥$27,091,279 (¥303,782 respondents × 1 hr × $89.18/hr). Accounting for the change in number of respondents, the decrease in the time to submit improvement activities data results in an adjustment of ¥124,670.33 hours at ¥$11,118,100.33 (136,004 respondents × 55 minutes/60 × $89.18/hr). When these adjustments are combined, the total adjustment is ¥428,452.33 hours (¥303,782¥124,670.33) hours at ¥$38,209,379.33 (¥$27,091,279¥$11,118,100.33). TABLE 82—ESTIMATED BURDEN FOR IMPROVEMENT ACTIVITIES SUBMISSION Total Number of Respondents (Groups, Virtual Groups, and Individual Clinicians) to submit improvement activities data on behalf of clinicians during the 2019 MIPS performance period (a) ..................................................................................................... Total Annual Hours Per Respondent (b) ............................................................................................................................................. Total Annual Hours (c) ................................................................................................................................................................. Labor rate for a computer systems analyst to submit improvement activities (d) .............................................................................. 136,004 5 minutes 11,333.7 $89.18/hr Total Annual Cost (e) = (a) * (d) .................................................................................................................................................. $1,010,736 VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00182 Fmt 4701 Sfmt 4700 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.078</GPH> amozie on DSK3GDR082PROD with RULES3 Burden estimate Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations amozie on DSK3GDR082PROD with RULES3 The following is a summary of the public comments received on the Quality Payment Program ICRs regarding Improvement Activities Submission: Comment: One commenter noted that CMS’s estimate of 5 minutes to submit data for the Improvement Activities performance category is low and should be increased to an estimate of between 15 and 30 minutes. Response: We thank the commenter for its input. We understand that some respondents may require additional time to submit improvement activities data above the 5 minutes we estimate, but we believe this estimate is a reasonable average across all respondents as it reflects the actual submission experience of the user. User experiences from the 2017 MIPS performance period reflect that the majority of users submit improvement activities data as part of the login and upload or direct submission types which allow multiple performance categories (i.e., quality and promoting interoperability) worth of data to be submitted at once. This results in less additional required time to submit improvement activities data which consists of manually attesting that certain activities were performed. In addition, as previously stated in the CY 2018 Quality Payment Program final rule, the same improvement activity may be reported across multiple performance periods so many MIPS eligible clinicians will not have any additional information to submit for the 2019 MIPS performance period, further reducing the average time spent reporting improvement activities data across all MIPS eligible clinicians (82 FR 53921). After consideration of public comments, we are making no changes to our estimates as a result of public comments received. However, the burden estimates have been updated from the CY 2019 PFS proposed rule to reflect availability of data from the 2017 MIPS performance period (83 FR 36033 through 36034). 13. Quality Payment Program ICRs Regarding the Nomination of Improvement Activities (§ 414.1360) The finalized requirements and burden discussed under this section will be submitted to OMB for approval under control number 0938–1314 (CMS–10621). We refer readers to the VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 CY 2018 Quality Payment Program final rule for our previous burden estimates for nomination of improvement activities under the Quality Payment Program (82 FR 53922). In this final rule, we have adjusted the number of respondents based on more recent data and adjusted our per response time estimate based on our review of our currently approved burden estimates against the existing process for nomination of improvement activities. As discussed in section III.I.3.h.(4)(d)(i)(A) of this final rule, we are also finalizing to adopt one new criteria and remove one existing criteria for nominating new improvement activities beginning with the CY 2019 performance period and future years. Furthermore, we have made clarifications to: (1) Considerations for selecting improvement activities for the CY 2019 performance period and future years; and (2) the weighting of improvement activities. We believe these policy changes will not affect our currently approved burden estimates since they do not substantively impact the level of effort previously estimated to nominate an Improvement Activity. As discussed in section III.I.3.h.(4)(d)(i)(D) of this final rule, we are finalizing changing the performance year for which the nominations will apply, such that improvement activities nominations received in a particular year will be vetted and considered for the next year’s rulemaking cycle for possible implementation in the following year. Also, as discussed in section III.I.3.h.(4)(d)(i)(D) of this final rule, we are finalizing changing the submission timeframe for the Call for Activities from February 1st through March 1st to February 1st through June 30th, providing approximately four additional months for stakeholders to submit nominations. We believe these policy changes will not affect our currently approved burden estimates since we believe that the number of nominations is unlikely to change, but the quality of the nominations is likely to increase given the additional time provided. For the 2018 MIPS performance period, we provided opportunity for stakeholders to propose new activities formally via the Annual Call for Activities nomination form that was posted on the CMS website (82 FR 53657). The 2018 Annual Call for PO 00000 Frm 00183 Fmt 4701 Sfmt 4700 60017 Activities lasted from March 2, 2017 through March 1, 2018, for which we received 72 nominations consisting of a total of 125 activities which were evaluated for the Improvement Activities Under Consideration (IAUC) list for possible inclusion in the CY 2019 Improvement Activities Inventory. Based on the number of activities being evaluated during the 2018 Annual Call for Activities (125 activities), we estimate that the total number of nominations we will receive for the 2019 Annual Call for Activities will continue to be 125, unchanged from the number of activities evaluated in CY 2018, which is a decrease from the 150 nominations currently approved by OMB. In the CY 2018 Quality Payment Program final rule, we estimated that it takes 0.5 hours to nominate an improvement activity (82 FR 53922). As shown in Table 83, due to a review of the nomination process including the criteria required to nominate an improvement activity, we now estimate it will take 2 hours (per organization) to submit an activity to us. Of those hours, we estimate it will take 1.2 hours at $107.38/hr for a practice administrator or equivalent to make a strategic decision to nominate and submit that activity and 0.8 hours at $206.44/hr for a clinician’s review. In aggregate, we estimate an annual burden of 250 hours (125 nominations × 2 hr/nomination) at a cost of $36,751 (125 × [(1.2 hr × $107.38/hr) + (0.8 hr × $206.44/hr)]). The percentage of practice administrator and clinician labor in relation to the total is unchanged from the CY 2018 Quality Payment Program final rule (82 FR 53922). Independent of the change to our per response time estimate, the decrease in the number of nominations results in an adjustment of ¥12.5 hours and ¥$1,837 (¥25 activities × [(0.3 hr × $107.38/hr) + (0.2 hr × $206.44/hr)]). Accounting for the decrease in the number of nominated improvement activities, the increase in time per nominated improvement activity results in an adjustment of 187.5 hours and $27,563 (125 activities × [(0.9 hr × $107.38/hr) + (0.6 hr × $206.44/hr)]). When these adjustments are combined, the total adjustment is 175 hours (187.5¥12.5) and $25,726 ($27,563¥$1,837). E:\FR\FM\23NOR3.SGM 23NOR3 60018 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations TABLE 83—ESTIMATED BURDEN FOR NOMINATION OF IMPROVEMENT ACTIVITIES amozie on DSK3GDR082PROD with RULES3 Burden estimate Number of Organizations Nominating New Improvement Activities (a) .............................................................................................. Number of Hours Per Practice Administrator to Identify and Propose Activity (b) ............................................................................. Number of Hours Per Clinician to Identify Activity (c) ......................................................................................................................... 125 1.2 0.8 Annual Hours Per Respondent (d) = (b) + (c) .................................................................................................................................... 2 Total Annual Hours (e) = (a) * (d) ................................................................................................................................................ 250 Cost to Identify and Submit Activity (@practice administrator’s labor rate of $107.38/hr.) (f) ........................................................... Cost to Identify Improvement Activity (@physician’s labor rate of $206.44/hr.) (g) ........................................................................... Total Annual Cost Per Respondent (h) = (f) + (g) .............................................................................................................................. $128.86 $165.15 $294.01 Total Annual Cost (i) = (a) * (h) ................................................................................................................................................... $36,751 The following is a summary of the public comments received on the Quality Payment Program ICRs regarding Improvement Activities Submission: Comment: One commenter noted that the burden estimate of 2 hours for nomination of Improvement Activities is low due to the time needed by clinicians and their staff to assess a need in their practice situation, formulate a creative solution, and determine how they would implement it in their practice in addition to documenting and submitting the improvement activity to CMS. Response: We recognize there is additional burden on respondents associated with development of a new improvement activity beyond the reporting burden estimated in the Collection of Information section of this policy which only accounts for the time required for record keeping, reporting, and third-party disclosures associated with the policy. We understand that some respondents may require additional time above the 2 hours we estimate for completing the process for nominating an improvement activity, but given that we do not include development of an improvement activity in our burden estimate, we believe this estimate is a reasonable average across all respondents based on our review of the nomination process, the information required to complete the nomination form, and the criteria required to nominate an improvement activity. After consideration of public comments, we are making no changes to our estimates as a result of public comments received. The burden estimates have not been updated from the CY 2019 PFS proposed rule (83 FR 36034 through 36035). VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 14. Quality Payment Program ICRs Regarding CMS Study on Factors Associated With Reporting Quality Measures During each performance year, eligible clinicians are recruited to participate in the CMS study on the burden associated with reporting quality measures. Eligible clinicians who are interested in participating can sign up whereby an adequate sample size is then selected by CMS from this group of potential participants. This study is ongoing, and participants are recruited on a yearly basis. Current participants can sign up when the study year ends. Section 1848(s)(7) of the Act, as added by section 102 of the MACRA (Pub. L. 114–10) states that Chapter 35 of title 44, United States Code, shall not apply to the collection of information for the development of quality measures. Consequently, we are not setting out such burden since the study shall inform us (and our contractors) on the root causes of clinicians’ performance measure data collection and data submission burdens and challenges that hinders accurate and timely quality measurement activities. We refer readers to the discussion of this policy in section VII.F.7 of this final rule. 15. Quality Payment Program ICRs Regarding the Cost Performance Category (§ 414.1350) The cost performance category relies on administrative claims data. The Medicare Parts A and B claims submission process (OMB control number 0938–1197) is used to collect data on cost measures from MIPS eligible clinicians. MIPS eligible clinicians are not required to provide any documentation by CD or hardcopy. Moreover, the provisions of this final rule do not result in the need to add or revise or delete any claims data fields. Therefore, we do not anticipate any new or additional submission requirements PO 00000 Frm 00184 Fmt 4701 Sfmt 4700 and/or burden for MIPS eligible clinicians resulting from the cost performance category. We received no public comments related to burden for the cost performance category. 16. Quality Payment Program ICRs Regarding Partial QP Elections (§ 414.1430) This rule does not include any new or revised reporting, recordkeeping, or third-party disclosure requirements related to QP elections. However, we have adjusted our currently approved burden estimates based on more recent data. The adjusted burden will be submitted to OMB for approval under control number 0938–1314 (CMS– 10621). APM Entities may face a data submission burden under MIPS related to Partial QP elections. Advanced APM participants will be notified about their QP or Partial QP status as soon as possible after each QP determination. Where Partial QP status is earned at the APM Entity level, the burden of Partial QP election will be incurred by a representative of the participating APM Entity. Where Partial QP status is earned at the eligible clinician level, the burden of Partial QP election will be incurred by the eligible clinician. For the purposes of this burden estimate, we assume that all MIPS eligible clinicians determined to be Partial QPs will participate in MIPS. Based on our predictive QP analysis for the 2019 QP performance period, we estimate that 6 APM Entities and 75 eligible clinicians will make the election to participate as a Partial QP in MIPS (see Table 84), an increase of 64 from the 17 elections currently approved by OMB under the aforementioned control number. We estimate it will take the APM Entity representative or eligible clinician 15 minutes (0.25 hr) to make this election. In aggregate, we estimate E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations an annual burden of 20.25 hours (81 respondents × .25 hr/election) at a cost of $1,805.90 (20.25 hours × $89.18/hr). The increase in the number of Partial QP elections results in an adjustment of 60019 16 hours and $1,431 (64 elections × 0.25 hrs × $89.18/hr). TABLE 84—ESTIMATED BURDEN FOR PARTIAL QP ELECTION Burden estimate Number of respondents making Partial QP election (6 APM Entities, 75 eligible clinicians) (a) ....................................................... Total Hours Per Respondent to Elect to Participate as Partial QP (b) ............................................................................................... Total Annual Hours (c) = (a) * (b) ....................................................................................................................................................... Labor rate for computer systems analyst (d) ...................................................................................................................................... 81 0.25 hours 20.25 hours $89.18/hr Total Annual Cost (d) = (c) * (d) .................................................................................................................................................. $1,805.90 We received no public comments related to the burden estimates for Partial QP Election. The burden estimates have not been updated from the CY 2019 PFS proposed rule (83 FR 36036). 17. Quality Payment Program ICRs Regarding Other Payer Advanced APM Determinations: Payer-Initiated Process (§ 414.1440) and Eligible Clinician Initiated Process (§ 414.1445) As indicated below, the finalized requirements and burden discussed under this section will be submitted to OMB for approval under control number 0938–1314 (CMS–10621). Payer Initiated Process (§ 414.1440): This rule does not include any new or revised reporting, recordkeeping, or third-party disclosure requirements related to the Payer Initiated Process. However, we have adjusted our currently approved burden estimates based on more recent data. The adjusted burden will be submitted to OMB for approval under control number 0938– 1314 (CMS–10621). Beginning in Quality Payment Program Year 3, the All-Payer Combination Option will be an available pathway to QP status for eligible clinicians participating sufficiently in Advanced APMs and Other Payer Advanced APMs. The All-Payer Combination Option allows for eligible clinicians to achieve QP status through their participation in both Advanced APMs and Other Payer Advanced APMs. In order to include an eligible clinician’s participation in Other Payer Advanced APMs in their QP threshold score, we will need to determine if certain payment arrangements with other payers meet the criteria to be Other Payer Advanced APMs. To provide eligible clinicians with advance notice prior to the start of a given performance period, and to allow other payers to be involved prospectively in the process, the 2018 CY Quality Payment Program final rule established a payer-initiated process for identifying payment arrangements that qualify as Other Payer Advanced APMs (82 FR 53844). The payer-initiated process for Other Payer Advanced APM determinations began in CY 2018 for Medicaid, Medicare Health Plans, and payers participating in CMS multi-payer models. Payers seeking to submit payment arrangement information for Other Payer Advanced APM determination through the payerinitiated process are required to complete a Payer Initiated Submission Form, instructions for which is available at https://qpp.cms.gov/. Determinations made in 2018 are applicable for the Quality Payment Program Year 3. Also in the CY 2018 Quality Payment Program final rule we established our intent to finalize that the remaining other payers, including commercial and other private payers, may request that we determine whether other payer arrangements are Other Payer Advanced APMs starting prior to the 2020 QP performance period and each performance period thereafter (82 FR 53867). As a result, in this final rule, we finalized our proposal to eliminate the Payer Initiated Process that is specifically for CMS Multi-Payer Models. We believe that payers aligned with CMS Multi-Payer Models can submit their arrangements through the Payer Initiated Process for Remaining Other Payers in section III.I.4.e.(4)(c) of this final rule, or through the Medicaid or Medicare Health Plan payment arrangement submission processes. As shown in Table 85, we estimate that in 2019 for the 2020 QP performance period 215 payer-initiated requests for Other Payer Advanced APM determinations will be submitted (15 Medicaid payers, 100 Medicare Advantage Organizations, and 100 remaining other payers), a decrease of 85 from the 300 total requests currently approved by OMB under the aforementioned control number. We estimate it will take 10 hours at $89.18/ hr for a computer system analyst per arrangement submission. In aggregate, we estimate an annual burden of 2,150 hours (215 submissions × 10 hr/ submission) at a cost of $191,737 (2,150 hr × $89.18/hr). The decrease in the number of payer-initiated requests results in an adjustment of ¥850 hours and ¥$75,803 (¥85 requests × 10 hr × $89.18/hr). TABLE 85—ESTIMATED BURDEN FOR OTHER PAYER ADVANCED APM IDENTIFICATION DETERMINATIONS: PAYER-INITIATED PROCESS amozie on DSK3GDR082PROD with RULES3 Burden estimate Number of other payer payment arrangements (15 Medicaid, 100 Medicare Advantage Organizations, 100 remaining other payers) (a) .............................................................................................................................................................................................. Total Annual Hours Per other payer payment arrangement (b) ......................................................................................................... 215 10 Total Annual Hours (c) = (a) * (b) ................................................................................................................................................ 2,150 Labor rate for a computer systems analyst (d) ................................................................................................................................... $89.18/hr VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00185 Fmt 4701 Sfmt 4700 E:\FR\FM\23NOR3.SGM 23NOR3 60020 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations TABLE 85—ESTIMATED BURDEN FOR OTHER PAYER ADVANCED APM IDENTIFICATION DETERMINATIONS: PAYER-INITIATED PROCESS—Continued Burden estimate Total Annual Cost for Other Payer Advanced APM determinations (e) = (a) * (d) ..................................................................... We received no public comments related to the burden estimates for Other Payer Advanced APM Identification Determinations: Payer-Initiated Process. The burden estimates have been updated from the CY 2019 PFS proposed rule to reflect updated respondent estimates (83 FR 36036 through 36037). Eligible Clinician Initiated Process (§ 414.1445): This rule does not include any new or revised reporting, recordkeeping, or third-party disclosure requirements related to the Eligible Clinician Initiated Process. However, we have adjusted our currently approved burden estimates based on more recent data. The adjusted burden will be submitted to OMB for approval under control number 0938–1314 (CMS– 10621). Beginning in Quality Payment Program Year 3, the All-Payer Combination Option will be an available pathway to QP status for eligible clinicians participating sufficiently in Advanced APMs and Other Payer Advanced APMs. The All-Payer Combination Option allows for eligible clinicians to achieve QP status through their participation in both Advanced APMs and Other Payer Advanced APMs. In order to include an eligible clinician’s participation in Other Payer Advanced APMs in their QP threshold score, we will need to determine if certain payment arrangements with other payers meet the criteria to be Other Payer Advanced APMs. To provide eligible clinicians with advanced notice prior to the start of a given performance period, and to allow other payers to be involved prospectively in the process, the CY 2018 Quality Payment Program final rule provided a payer-initiated identification process for identifying payment arrangements that qualify as Other Payer Advanced APMs (82 FR 53854). In the same rule, under the Eligible Clinician Initiated Process, APM Entities and eligible clinicians participating in other payer arrangements will have an opportunity to request that we determine for the year whether those other payer arrangements are Other Payer Advanced APMs (82 FR 53857—53858). However, to appropriately implement the statutory requirement to exclude from the All Payer Combination Option QP threshold calculations certain Title XIX payments and patients, we determined it will be problematic to allow APM Entities and eligible clinicians to request determinations for Title XIX payment arrangements after the conclusion of the QP performance period because any late-identified Medicaid APM or Medicaid Medical Home Model that meets the Other Payer Advanced APM criteria could unexpectedly affect QP threshold calculations for every other clinician in that state (or county). Thus, the CY 2018 Quality Payment Program final rule provided that APM Entities and eligible clinicians may request determinations for any Medicaid payment arrangements in which they are participating at an earlier point, prior to the start of a given QP performance period (82 FR 53858). This will allow all clinicians in a given state $191,737 or county to know before the beginning of the performance period whether their Title XIX payments and patients will be excluded from the all-payer calculations that are used for QP determinations for the year under the All-Payer Combination Option. This Medicaid specific eligible clinician-initiated determination process for Other Payer Advanced APMs also began in CY 2018, and determinations made in 2018 are applicable for the Quality Payment Program Year 3. Eligible clinicians or APM Entities seeking to submit payment arrangement information for Other Payer Advanced APM determination through the Eligible Clinician-Initiated process are required to complete an Eligible Clinician Initiated Submission Form, instructions for which is available at https:// qpp.cms.gov/. As shown in Table 86, we estimate that 150 other payer arrangements will be submitted by APM Entities and eligible Other Payer Advanced APM determinations, an increase of 75 from the 75 total requests currently approved by OMB under the aforementioned control number. We estimate it will take 10 hours at $89.18/hr for a computer system analyst per arrangement submission to submit this data. In aggregate, we estimate an annual burden of 1,500 hours (150 submissions × 10 hr/submission) at a cost of $133,770 (1,500 hr × $89.18/hr). The increase in the number of clinicianinitiated requests results in an adjustment of 750 hours and $66,885 (75 requests × 10 hr × $89.18/hr). TABLE 86—ESTIMATED BURDEN FOR OTHER PAYER ADVANCED APM DETERMINATIONS: ELIGIBLE CLINICIAN INITIATED PROCESS amozie on DSK3GDR082PROD with RULES3 Burden estimate Number of other payer payment arrangements from APM Entities and eligible clinicians ................................................................ Total Annual Hours Per other payer payment arrangement (b) ......................................................................................................... 150 10 Total Annual Hours (c) = (a) * (b) ................................................................................................................................................ 1,500 Labor rate for a computer systems analyst (d) ................................................................................................................................... $89.18/hr Estimated Total Annual Cost for Other Payer Advanced APM determinations (e) = (a) * (d) .................................................... $133,770 We received no public comments related to the burden estimates for Other VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 Payer Advanced APM Identification Determinations: Eligible Clinician PO 00000 Frm 00186 Fmt 4701 Sfmt 4700 Initiated Process. The burden estimates have not been updated from the CY E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 2019 PFS proposed rule (83 FR 36037 through 36038). Submission of Data for QP Determinations under the All-Payer Combination Option (§ 414.1440): The following reflects the burden associated with the first year of data collection resulting from policies set out in the CY 2018 Quality Payment Program final rule. Because no collection of data was required prior to the CY 2019 performance period, the requirements and burden were not submitted to OMB for approval. However, by virtue of this rulemaking, the requirements and burden will be submitted to OMB for approval under control number 0938– 1314 (CMS–10621). The CY 2017 Quality Payment Program final rule provided that either APM Entities or individual eligible clinicians must submit by a date and in a manner determined by us: (1) Payment arrangement information necessary to assess whether each other payer arrangement is an Other Payer Advanced APM, including information on financial risk arrangements, use of CEHRT, and payment tied to quality measures; (2) for each payment arrangement, the amounts of payments for services furnished through the arrangement, the total payments from the payer, the numbers of patients furnished any service through the arrangement (that is, patients for whom the eligible clinician is at risk if actual expenditures exceed expected expenditures), and (3) the total number of patients furnished any service through the arrangement (81 FR 77480). The rule also specified that if we do not receive sufficient information to complete our evaluation of another payer arrangement and to make QP determinations for an eligible clinician using the All-Payer Combination Option, we will not assess the eligible clinicians under the All-Payer Combination Option (81 FR 77480). In the CY 2018 Quality Payment Program final rule, we explained that in order for us to make QP determinations under the All-Payer Combination Option using either the payment amount or patient count method, we will need to receive all of the payment amount and patient count information: (1) Attributable to the eligible clinician or APM Entity through every Other Payer Advanced APM; and (2) for all other payments or patients, except from excluded payers, made or attributed to the eligible clinician during the QP performance period (82 FR 53885). We also finalized that eligible clinicians and APM Entities will not need to submit Medicare payment or patient information for QP determinations under the All-Payer Combination Option (82 FR 53885). The CY 2018 Quality Payment Program final rule noted that we will need this payment amount and patient count information for the periods January 1 through March 31, January 1 through June 30, and January 1 through August 31 (82 FR 53885). We noted that the timing may be challenging for APM Entities or eligible clinicians to submit information for the August 31 snapshot date. If we receive information for either the March 31 or June 30 snapshots, but not the August 31 snapshot, we will use that information to make QP determinations under the All-Payer Combination Option. This payment amount and patient count information is to be submitted in a way that allows us to distinguish information from January 1 through March 31, January 1 through June 30, and January 1 through August 31 so that we can make QP determinations based on the two finalized snapshot dates (82 FR 30203 through 30204). The CY 2018 Quality Payment Program final rule specified that APM Entities or eligible clinicians must submit all of the required information about the Other Payer Advanced APMs in which they participate, including those for which there is a pending request for an Other Payer Advanced APM determination, as well as the payment amount and patient count 60021 information sufficient for us to make QP determinations by December 1 of the calendar year that is 2 years to prior to the payment year, which we refer to as the QP Determination Submission Deadline (82 FR 53886). In section III.I.4.e.(5)(b) of this final rule, we are finalizing the addition of a third alternative to allow QP determinations at the TIN level in instances where all clinicians who have reassigned billing rights to the TIN participate in a single (the same) APM Entity. This option will therefore be available to all TINs participating in Full TIN APMs, such as the Medicare Shared Savings Program. It will also be available to any other TIN for which all clinicians who have reassigned billing rights to the TIN participating in a single APM Entity. To make QP determinations under the All-Payer Combination Option at the TIN level as finalized using either the payment amount or patient count method, we will need to receive, by December 1 of the calendar year that is 2 years to prior to the payment year, all of the payment amount and patient count information: (1) Attributable to the eligible clinician, TIN, or APM Entity through every Other Payer Advanced APM; and (2) for all other payments or patients, except from excluded payers, made or attributed to the eligible clinician(s) during the QP performance period for the periods January 1 through March 31, January 1 through June 30, and January 1 through August 31. As shown in Table 87, we assume that 4 APM Entities, 225 TINs, and 80 eligible clinicians will submit data for QP determinations under the All-Payer Combination Option in 2019. We estimate it will take the APM Entity representative, TIN representative, or eligible clinician 5 hours at $107.38/hr for a practice administrator to complete this submission. In aggregate, we estimate an annual burden of 1,545 hours (309 respondents × 5 hr) at a cost of $165,902 (1,545 hr × $107.38/hr). TABLE 87—ESTIMATED BURDEN FOR THE SUBMISSION OF DATA FOR ALL-PAYER QP DETERMINATIONS amozie on DSK3GDR082PROD with RULES3 Burden estimate # of APM Entities submitting data for All-Payer QP Determinations (a) ............................................................................................ # of TINs submitting data for All-Payer QP Determinations (b) .......................................................................................................... # of eligible submitting data for All-Payer QP Determinations (c) ...................................................................................................... Hours Per respondent QP Determinations (d) .................................................................................................................................... 4 225 80 5 Total Hours (g) = [(a) * (d)] + [(b) * (d)] + [(c) * (d)] .................................................................................................................... 1,545 Labor rate for a Practice Administrator ($107.38) (h) ......................................................................................................................... $107.38/hr Total Annual Cost for Submission of Data for All-Payer QP Determinations (i) = (g) * (h) ........................................................ $165,902 VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00187 Fmt 4701 Sfmt 4700 E:\FR\FM\23NOR3.SGM 23NOR3 60022 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations We received no public comments related to the burden estimates for the Submission of Data for All-Payer QP Determinations. The burden estimates have been updated from the CY 2019 PFS proposed rule to reflect updated respondent estimates (83 FR 36038 through 36039). 18. Quality Payment Program ICRs Regarding Voluntary Participants Election To Opt-Out of Performance Data Display on Physician Compare (§ 414.1395) This rule does not include any new or revised reporting, recordkeeping, or third-party disclosure requirements related to the election by voluntary participants to opt-out of public reporting on Physician Compare. However, we have adjusted our currently approved burden estimates based on more recent data. The adjusted burden will be submitted to OMB for approval under control number 0938– 1314 (CMS–10621). We estimate that 10 percent of the total clinicians and groups who will voluntarily participate in MIPS will also elect not to participate in public reporting. This results in a total of 11,617 (10 percent × 116,174 voluntary MIPS participants), a decrease of 10,783 from the total respondents currently approved by OMB under the aforementioned control number due to the reduction in voluntary participation in MIPS overall. As we discussed earlier in this section of the final rule, voluntary respondents are clinicians that are not QPs and are expected to be excluded from MIPS after applying the eligibility requirements discussed in section III.I.3.a. of this final rule, but have elected to submit data to MIPS. In implementing the finalized opt-in policy, we estimate that 33 percent of clinicians that exceed 1 of the lowvolume criteria, but not all 3, will elect to opt-in to MIPS, become MIPS eligible, and no longer be considered a voluntary reporter. This logic was also applied in the regulatory impact analysis of this rule. Table 88 shows that for these voluntary participants, we estimate it will take 0.25 hours at $89.18/hr for a computer system analyst to submit a request to opt-out. In aggregate, we estimate an annual burden of 2,904.25 hours (11,617 requests × 0.25 hr/ request) at a cost of $259,001 (2,904.25 hr × $89.18/hr). The decrease in the number of respondents due to policies finalized in this rule results in a decrease of ¥2,695.75 hours (¥10,783 respondents × 0.25 hr) and ¥$240,407 (¥2,695.75 hours × $89.18/hr). TABLE 88—ESTIMATED BURDEN FOR VOLUNTARY PARTICIPANTS TO ELECT OPT OUT OF PERFORMANCE DATA DISPLAY ON PHYSICIAN COMPARE Burden estimate # of Voluntary Participants Opting Out of Physician Compare (a) ..................................................................................................... Total Annual Hours Per Opt-out Requester (b) .................................................................................................................................. 11,617 0.25 Total Annual Hours for Opt-out Requester (c) = (a) * (b) ............................................................................................................ 2,904.25 Labor rate for a computer systems analyst (d) ................................................................................................................................... $89.18/hr Total Annual Cost for Opt-out Requests (e) = (a) * (d) ............................................................................................................... $259,001 amozie on DSK3GDR082PROD with RULES3 We received no public comments related to the burden estimates for voluntary participants to elect to opt out of performance data display on Physician Compare. However, the burden estimates have not been updated from the CY 2019 PFS proposed rule to reflect availability of data from the 2017 MIPS performance period (83 FR 36039). VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 19. Summary of Annual Quality Payment Program Burden Estimates Table 89 summarizes this final rule’s burden estimates for the Quality Payment Program. To understand the burden implications of the policies finalized in this rule, we have also estimated a baseline burden of continuing the policies and information collections set forth in the CY 2018 Quality Payment Program final rule into PO 00000 Frm 00188 Fmt 4701 Sfmt 4700 the 2019 MIPS performance period. Our baseline burden estimates reflect the recent availability of data sources to more accurately reflect the number of the respondents for the quality, Promoting Interoperability, and improvement activities performance categories and the number of organizations exempt from the Promoting Interoperability performance category. BILLING CODE 4120–01–P E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60023 TABLE 89: Summary of Finalized Quality Payment Program Burden Estimates and Change Currently Approved Total Burden Finalized Total Burden Hours Change in Total Burden Hours 278,039 257,260 -20,779 4,949,094 3,653,092 -1,296,002 107,217 81,981 -25,236 973,852 744,633 -229,219 54,218 51,861 -2,357 487,962 414,888 -73,074 296 286 -10 21,904 17,636.7 -4,267.3 10 67 57 10 16.75 6.75 40 140 100 20 630 610 40,645 6,041 -34,604 20,323 1,510 -18,813 218,215 93,869 -124,346 654,645 250,317 -404,328 40 47 7 20 23.5 3.5 439,786 136,004 -303,782 439,786 11,334 -428,452 150 125 -25 75 250 175 17 81 64 4.25 20.25 16 300 215 -85 3,000 2,150 -850 75 150 75 750 1,500 750 0 309 309 0 1,545 1,545 *These two ICRs were combined in a single ICR in the CY 2018 Quality Payment Program fmal rule (82 FR 53906 through 53907). BILLING CODE 4120–01–C VerDate Sep<11>2014 19:26 Nov 21, 2018 Table 90 provides the reasons for changes in the estimated burden for Jkt 247001 PO 00000 Frm 00189 Fmt 4701 Sfmt 4700 information collections in this final rule. We have divided the reasons for E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.079</GPH> amozie on DSK3GDR082PROD with RULES3 Compare) Opt Out for 60024 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations our change in burden into those related to new policies and those related to changes in the baseline burden of continued Quality Payment Program Year 2 policies that reflect updated data and methods. TABLE 90—REASONS FOR CHANGE IN BURDEN COMPARED TO THE CURRENTLY APPROVED CY 2018 INFORMATION COLLECTION BURDENS Table in collection of information Changes in burden due to finalized Year 3 policies Changes to ‘‘baseline’’ of burden continued Year 2 policy (italics are changes in number of respondents’ due to updated data) Table 62: Qualified Registry Self-Nomination. None ....................................................... Table 63: QCDR Self-Nomination .......... None ....................................................... Table 68: Quality Payment Program Identity Management Application Process. None ....................................................... Table 69: Quality Performance Category Medicare Part B Claims Collection Type. None ....................................................... After a review of the self-nomination process, we determined it is more accurate to separately assess the burden of Qualified Registry and QCDR self-nomination rather than aggregate them in the same ICR. Review of self-nomination process resulted in a decrease in estimated time needed to complete simplified self-nomination (¥9.5 hr. computer system analyst time) and full self-nomination (¥7 hr. computer system analyst time). Increase in the number of respondents as the number of qualified registries enrolling increases and the basis for estimating the number of respondents is updated to reflect the number of self-nomination applications received in place of the number of qualified registries being approved. After a review of the self-nomination process, we determined it is more accurate to separately assess the burden of Qualified Registry and QCDR self-nomination rather than aggregate them in the same ICR. Review of self-nomination process resulted in an increase in estimated time needed to complete simplified self-nomination (¥0.5 hr. computer system analyst time) and full self-nomination (+2 hr. computer system analyst time). Increase in the number of respondents as the number of QCDRs enrolling increases and the basis for estimating the number of respondents is updated to reflect the number of self-nomination applications received in place of the number of QCDRs being approved. Decreased number of respondents due to updates to the identity management system being used for data submission in the 2018 MIPS performance period; only new respondents submitting quality data using the CMS Enterprise Portal need to create a new account, versus system where all respondents submitting via EHR needed to register for user account annually. Decreased number of respondents due to updated data from 2017 MIPS performance period. Table 70: Quality Performance Category QCDR/MIPS CQM Collection Type. Table 71: Quality Performance Category eCQM Collection Type. Table 72: Quality Performance Category CMS Web Interface. amozie on DSK3GDR082PROD with RULES3 Table 73: Beneficiary Responses to CAHPS for MIPS Survey. None ....................................................... None ....................................................... Decrease in number of required measures resulted in reduction in estimated time needed to submit data (¥12.33 hrs computer system analyst time). None ....................................................... Table 74: Registration for CMS Web Interface. None ....................................................... Table 75: Registration for CAHPS for MIPS Survey. None ....................................................... Table 76: Call for Quality Measures ....... None ....................................................... Table 77: Reweighting Applications for Promoting Interoperability and Other Performance Categories. None ....................................................... Table 79: Promoting Interoperability Performance Category Data Submission. Table 80: Call for Promoting Interoperability Measures. Table 82: Improvement Activities Submission. VerDate Sep<11>2014 19:26 Nov 21, 2018 Decrease in number of required measures resulted in reduction in estimated time needed to submit data (¥.33 hr computer system analyst time). None ....................................................... None ....................................................... Jkt 247001 PO 00000 Frm 00190 Fmt 4701 Correction to estimate to account for reduced number of required measures compared to PQRS (6 in MIPS; 9 in PQRS) reduced estimated time to submit data. Decreased number of respondents due to updated data from 2017 MIPS performance period. Decreased number of respondents due to updated data from 2017 MIPS performance period. Decrease in the number of respondents due to updated data from the 2018 MIPS performance period as fewer eligible group practices elected to submit data using the CMS Web Interface. Decrease in the number of respondents due to updated data from the 2018 MIPS performance period as fewer eligible group practices elect to have vendors administer the CAHPS for MIPS survey and fewer beneficiaries per group respond to the survey, on average. Increase in the number of respondents due to updated data from the 2018 MIPS performance period as more groups register to submit data using the CMS Web Interface. Review of registration process resulted in decrease in estimated time to register. (¥0.75 hr. computer system analyst time). Decrease in the number of respondents due to updated data from the 2018 MIPS performance period as fewer eligible group practices elect to have vendors administer the CAHPS for MIPS survey. Review of registration process resulted in decrease in estimated time to register. (¥0.75 hr. computer system analyst time). Increase in the number of new quality measures being nominated. Inclusion of time required to complete Peer Review Journal Article Form resulted in increase in time to nominate a quality measure. This was a requirement in the CY 2017 Quality Payment Program final rule (81 FR 77153 through 77155) but was not included in burden estimates. (+4 hrs Physician time). Decrease in the number of respondents due to updated data from 2017 MIPS performance period. Review of application process resulted in decrease in estimated time to apply (¥0.25 hr computer system analyst time). Decrease in the number of respondents due to updated data from 2017 MIPS performance period. Increase in the number of new Promoting Interoperability measures being nominated. Decrease in the number of respondents due to updated data from 2017 MIPS performance period. Sfmt 4700 E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60025 TABLE 90—REASONS FOR CHANGE IN BURDEN COMPARED TO THE CURRENTLY APPROVED CY 2018 INFORMATION COLLECTION BURDENS—Continued Changes in burden due to finalized Year 3 policies Table in collection of information Changes to ‘‘baseline’’ of burden continued Year 2 policy (italics are changes in number of respondents’ due to updated data) Table 83: Nomination of Improvement Activities. None ....................................................... Table 84: Partial QP Election ................. None ....................................................... Table 85: Other Payer Advanced APM Identification: Other Payer Initiated Process. Table 86: Other Payer Advanced APM Identification: Eligible Clinician Initiated Process. Table 87: Submission of Data for AllPayer QP Determinations under the All-Payer Combination Option. Table 88: Voluntary Participants to Elect to Opt Out of Performance Data Display on Physician Compare. None ....................................................... None ....................................................... Reflects new policy in this final rule. ..... Decrease in the number of respondents due to updated data from 2017 MIPS performance period. Review of submission process resulted in decrease in estimated to submit (¥0.92 hr computer system analyst time). Review of nomination process resulted in increase in estimated time to nominate a new improvement activity (+0.9 hrs Practice Administrator time; +0.6 hrs Physician time). Increase in the number of respondents due to additional APM Entities and eligible clinicians electing to participate as a Partial QP in MIPS. Decrease in the number of anticipated other payer arrangements submitted for identification as Other Payer Advanced APMs. Increase in the number of anticipated other payer arrangements submitted by APM Entities and eligible clinicians for identification as Other Payer Advanced APMs. None. None. C. Summary of Annual Burden Estimates for Finalized Requirements TABLE 91—ANNUAL REQUIREMENTS AND BURDEN Regulation section(s) under Title 42 of the CFR § 414.94(j) (AUC consultations) Voluntary period. § 414.94(j) (AUC consultations) Beginning Jan 1, 2020. § 414.94 (AUC recordkeeping) ........................ OMB control No. *** Respondents 0938–1345 10,230,000 3,410,000 0938–1345 586,386 43,181,818 0938–1345 586,386 6,699 Responses Burden per response (hours) Total annual burden (hours) Labor cost of reporting ($/hr) Total cost ($) * (See Subtotal 0938–1314 (**) (517,537) 0.033 ............... (2 min) ............. 0.033 ............... (2 min) ............. 0.167 ............... (10 min) ........... varies ............... (See Subtotal 0938–1222 (93,447) (93,447) varies ............... (21,195) varies ............... (546,362) Total .......................................................... ...................... 10,722,939 45,987,533 Varies .............. (932,880) Varies .............. (146,488,260) Quality Under Quality Under Payment Program Table 89). Payment Program Table 89). 112,530 Varies .............. 5,527,924 1,425,000 Varies .............. 70,001,700 1,119 34.50 ............... 38,596 (2,450,334) varies ............... (221,510,118) * For the PRA, this rule will not impose any non-labor costs. ** We are unable to accurately calculate a total number of respondents for the Quality Payment Program. In many cases, individuals, groups, and entities have responded to multiple data collections and there is no unified way to identify unique respondents. *** OMB and CMS’ PRA package ID numbers: OMB 0938–1345 (CMS–10654), OMB 0938–1314 (CMS–10621), and OMB 0938–1222 (CMS–10450). **** For OMB 0938–1314 (CMS–10621), the estimated total number of respondents across all ICRs for the CY 2019 performance period is 644,144 while estimated total burden hours are 5,109,042 at a cost of $482,416,597. (CMS–10450), the estimated total number of respondents across all ICRs for the CY 2019 performance period is 39,336 while estimated total burden hours are 8,755 at a cost of $236,525. For OMB 0938–1343 (CMS–10652), the estimated total number of respondents across all ICRs for the CY 2019 performance period is 16 while estimated total burden hours are 160 at a cost of $13,506. VII. Regulatory Impact Analysis amozie on DSK3GDR082PROD with RULES3 A. Statement of Need This final rule makes payment and policy changes under the Medicare PFS and implements required statutory changes under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), the Achieving a Better Life Experience Act (ABLE), the Protecting Access to Medicare Act of 2014 (PAMA), section 603 of the Bipartisan Budget Act of 2015, the Consolidated Appropriations Act of 2016, the Bipartisan Budget Act of 2018, and section 2001(a) of the SUPPORT for Patients and Communities Act of 2018. This final rule also makes changes to payment policy and other related policies for Medicare Part B. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 This final rule is necessary to make policy changes under Medicare fee-forservice. Therefore, we included a detailed regulatory impact analysis (RIA) to assess all costs and benefits of available regulatory alternatives and explained the selection of these regulatory approaches that we believe adhere to section 1834(q) of the Act and, to the extent feasible, maximize net benefits. This final rule also makes payment and policy changes under the Medicare PFS and makes required statutory changes under the MACRA, as amended by section 51003 of the Bipartisan Budget Act of 2018. The new policies for CY 2019 are detailed throughout this final rule. For example, the policies associated with PO 00000 Frm 00191 Fmt 4701 Sfmt 4700 modernizing Medicare physician payment by recognizing communication technology-based services are described in section II.D. of this final rule, while the policies associated with E/M visits are described in section II.I. of this final rule. Several policies addressing the use of innovative technology that enables remote services will expand access to care and create more opportunities for patients to access more personalized care management, as well as connect with their physicians more quickly. These policies support access to care using telecommunications technology by paying clinicians for virtual checkins (brief, non-face-to-face appointments via communications technology), paying clinicians for evaluation of patientsubmitted photos or videos, and E:\FR\FM\23NOR3.SGM 23NOR3 60026 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations amozie on DSK3GDR082PROD with RULES3 expanding Medicare-covered telehealth services to include prolonged preventive services. Several policies in the final rule will also give physicians more time to spend with their patients, especially those with complex needs, rather than on paperwork. Specifically, there are provisions that simplify certain documentation requirements for E/M visits, which make up about 40 percent of allowed charges under the PFS and consume much of clinicians’ time; reduce supervision requirements for radiologist assistants during diagnostic test services; and remove burdensome and overly complex functional reporting requirements for outpatient therapy. In addition, section VII.H. of this final rule, the RIA, details the economic effect of these policies on Medicare providers and beneficiaries. B. Overall Impact We examined the impact of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (February 2, 2013), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96–354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104–4), Executive Order 13132 on Federalism (August 4, 1999), the Congressional Review Act (5 U.S.C. 804(2)), and Executive Order 13771 on Reducing Regulation and Controlling Regulatory Costs (January 30, 2017). Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). An RIA must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). We estimated, as discussed in this section, that the PFS policies included in this final rule would redistribute more than $100 million in 1 year. Therefore, we estimate that this rulemaking is ‘‘economically significant’’ as measured by the $100 million threshold, and hence also a major rule under the Congressional Review Act. Accordingly, we prepared an RIA that, to the best of our ability, presents the costs and benefits of the rulemaking. The RFA requires agencies to analyze options for regulatory relief of small entities. For purposes of the VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals, practitioners and most other providers and suppliers are small entities, either by nonprofit status or by having annual revenues that qualify for small business status under the Small Business Administration standards. (For details see the SBA’s website at https:// www.sba.gov/content/table-smallbusiness-size-standards (refer to the 620000 series)). Individuals and states are not included in the definition of a small entity. The RFA requires that we analyze regulatory options for small businesses and other entities. We prepare a regulatory flexibility analysis unless we certify that a rule would not have a significant economic impact on a substantial number of small entities. The analysis must include a justification concerning the reason action is being taken, the kinds and number of small entities the rule affects, and an explanation of any meaningful options that achieve the objectives with less significant adverse economic impact on the small entities. Approximately 95 percent of practitioners, other providers, and suppliers are considered to be small entities, based upon the SBA standards. There are over 1 million physicians, other practitioners, and medical suppliers that receive Medicare payment under the PFS. Because many of the affected entities are small entities, the analysis and discussion provided in this section, as well as elsewhere in this final rule is intended to comply with the RFA requirements regarding significant impact on a substantial number of small entities. For example, the effects of changes to payment rates for practitioners, other providers, and suppliers are discussed in VII.C. of this final rule. Alternative options considered to the payment rates are discussed generally in section VII.F. of this final rule. In addition, section 1102(b) of the Act requires us to prepare an RIA if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area for Medicare payment regulations and has fewer than 100 beds. The PFS does not reimburse for services provided by rural hospitals; the PFS pays for physicians’ services, which can be furnished by physicians and nonphysician practitioners in a variety of PO 00000 Frm 00192 Fmt 4701 Sfmt 4700 settings, including rural hospitals. We did not prepare an analysis for section 1102(b) of the Act because we determined, and the Secretary certified, that this final rule would not have a significant impact on the operations of a substantial number of small rural hospitals. Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits on state, local, or tribal governments or on the private sector before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2018, that threshold is approximately $150 million. This final rule will impose no mandates on state, local, or tribal governments or on the private sector. Executive Order 13132 establishes certain requirements that an agency must meet when it issues a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has Federalism implications. Since this regulation does not impose any costs on state or local governments, the requirements of Executive Order 13132 are not applicable. Executive Order 13771, entitled Reducing Regulation and Controlling Regulatory Costs (82 FR 9339), was issued on January 30, 2017. This final rule is considered an E.O. 13771 deregulatory action because it is expected to result in regulatory cost savings. The estimated impact would be $71 million in cost savings in 2019, $3.986 billion in costs in 2020, $387 million in cost savings in 2021, $450 million cost savings in 2022, and $557 million in cost savings in 2023 and thereafter. Annualizing these costs and cost savings in perpetuity and discounting at 7 percent back to 2016, we estimated that this rule would generate $190 million in annualized net cost savings for E.O. 13771 accounting purposes. Details on the estimated cost savings of this rule can be found in the following analyses. We prepared the following analysis, which together with the information provided in the rest of this preamble, meets all assessment requirements. The analysis explains the rationale for and purposes of this final rule; details the costs and benefits of the rule; analyzes alternatives; and presents the measures we would use to minimize the burden on small entities. As indicated elsewhere in this final rule, we are implementing a variety of changes to our regulations, payments, or payment policies to ensure that our payment E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations systems reflect changes in medical practice and the relative value of services, and implementing statutory provisions. We provided information for each of the policy changes in the relevant sections of this final rule. We are unaware of any relevant federal rules that duplicate, overlap, or conflict with this final rule. The relevant sections of this final rule contain a description of significant alternatives if applicable. C. Changes in Relative Value Unit (RVU) Impacts 1. Resource-Based Work, PE, and MP RVUs Section 1848(c)(2)(B)(ii)(II) of the Act requires that increases or decreases in RVUs may not cause the amount of expenditures for the year to differ by more than $20 million from what expenditures would have been in the absence of these changes. If this threshold is exceeded, we make adjustments to preserve budget neutrality. Our estimates of changes in Medicare expenditures for PFS services compared payment rates for CY 2018 with payment rates for CY 2019 using CY 2017 Medicare utilization. The payment impacts in this final rule reflect averages by specialty based on Medicare utilization. The payment impact for an individual practitioner could vary from the average and would depend on the mix of services he or she furnishes. The average percentage change in total revenues will be less than the impact displayed here because practitioners and other entities generally furnish services to both Medicare and nonMedicare patients. In addition, practitioners and other entities may receive substantial Medicare revenues for services under other Medicare payment systems. For instance, independent laboratories receive approximately 83 percent of their Medicare revenues from clinical laboratory services that are paid under the Clinical Laboratory Fee Schedule (CLFS). The annual update to the PFS conversion factor (CF) was previously calculated based on a statutory formula; for details about this formula, we refer 60027 readers to the CY 2015 PFS final rule with comment period (79 FR 67741 through 67742). Section 101(a) of the MACRA repealed the previous statutory update formula and amended section 1848(d) of the Act to specify the update adjustment factors for CY 2015 and beyond. The update adjustment factor for CY 2019, as required by section 53106 of the Bipartisan Budget Act of 2018, is 0.25 percent before applying other adjustments. To calculate the CF for this year, we multiplied the product of the current year CF and the update adjustment factor by the budget neutrality adjustment described in the preceding paragraphs. We estimated the CY 2019 PFS CF to be 36.0391 which reflects the budget neutrality adjustment under section 1848(c)(2)(B)(ii)(II) and the 0.25 percent update adjustment factor specified under section 1848(d)(18) of the Act. We estimate the CY 2019 anesthesia CF to be 22.2730, which reflects the same overall PFS adjustments with the addition of anesthesia-specific PE and MP adjustments. TABLE 92—CALCULATION OF THE FINAL CY 2019 PFS CONVERSION FACTOR CY 2018 Conversion Factor ......................................................................................... Statutory Update Factor ........................................................................................ CY 2019 RVU Budget Neutrality Adjustment ....................................................... CY 2019 Conversion Factor ......................................................................................... ................................................................... 0.25 percent (1.0025) ............................... ¥0.14 percent (0.9986) ............................ ................................................................... 35.9996 ........................ ........................ 36.0391 TABLE 93—CALCULATION OF THE FINAL CY 2019 ANESTHESIA CONVERSION FACTOR amozie on DSK3GDR082PROD with RULES3 CY 2018 National Average Anesthesia Conversion Factor ......................................... Statutory Update Factor ........................................................................................ CY 2019 RVU Budget Neutrality Adjustment ....................................................... CY 2019 Anesthesia Fee Schedule Practice Expense and Malpractice Adjustment. CY 2019 Conversion Factor ......................................................................................... Table 94 shows the payment impact on PFS services of the policies contained in this final rule. To the extent that there are year-to-year changes in the volume and mix of services provided by practitioners, the actual impact on total Medicare revenues would be different from those shown in Table 94 (CY 2019 PFS Estimated Impact on Total Allowed Charges by Specialty). The following is an explanation of the information represented in Table 94. • Column A (Specialty): Identifies the specialty for which data are shown. • Column B (Allowed Charges): The aggregate estimated PFS allowed charges for the specialty based on CY VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 ................................................................... 0.25 percent (1.0025) ............................... ¥0.14 percent (0.9986) ............................ 0.27 percent (1.0027) ............................... 22.1887 ........................ ........................ ........................ ................................................................... 22.2730 2017 utilization and CY 2018 rates. That is, allowed charges are the PFS amounts for covered services and include coinsurance and deductibles (which are the financial responsibility of the beneficiary). These amounts have been summed across all services furnished by physicians, practitioners, and suppliers within a specialty to arrive at the total allowed charges for the specialty. • Column C (Impact of Work RVU Changes): This column shows the estimated CY 2019 impact on total allowed charges of the changes in the work RVUs, including the impact of changes due to potentially misvalued codes. PO 00000 Frm 00193 Fmt 4701 Sfmt 4700 • Column D (Impact of PE RVU Changes): This column shows the estimated CY 2019 impact on total allowed charges of the changes in the PE RVUs. • Column E (Impact of MP RVU Changes): This column shows the estimated CY 2019 impact on total allowed charges of the changes in the MP RVUs. • Column F (Combined Impact): This column shows the estimated CY 2019 combined impact on total allowed charges of all the changes in the previous columns. Column F may not equal the sum of columns C, D, and E due to rounding. E:\FR\FM\23NOR3.SGM 23NOR3 60028 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations TABLE 94—CY 2019 PFS ESTIMATED IMPACT ON TOTAL ALLOWED CHARGES BY SPECIALTY Specialty Allowed charges (mil) Impact of work RVU changes (%) Impact of PE RVU changes (%) Impact of MP RVU changes (%) Combined impact (%) (A) (B) (C) (D) (E) (F) Allergy/Immunology .............................................................. Anesthesiology ..................................................................... Audiologist ............................................................................ Cardiac Surgery ................................................................... Cardiology ............................................................................ Chiropractor ......................................................................... Clinical Psychologist ............................................................ Clinical Social Worker .......................................................... Colon and Rectal Surgery ................................................... Critical Care ......................................................................... Dermatology ......................................................................... Diagnostic Testing Facility ................................................... Emergency Medicine ........................................................... Endocrinology ...................................................................... Family Practice .................................................................... Gastroenterology .................................................................. General Practice .................................................................. General Surgery ................................................................... Geriatrics .............................................................................. Hand Surgery ....................................................................... Hematology/Oncology .......................................................... Independent Laboratory ....................................................... Infectious Disease ................................................................ Internal Medicine .................................................................. Interventional Pain Mgmt ..................................................... Interventional Radiology ...................................................... Multispecialty Clinic/Other Phys .......................................... Nephrology ........................................................................... Neurology ............................................................................. Neurosurgery ....................................................................... Nuclear Medicine ................................................................. Nurse Anes/Anes Asst ......................................................... Nurse Practitioner ................................................................ Obstetrics/Gynecology ......................................................... Ophthalmology ..................................................................... Optometry ............................................................................ Oral/Maxillofacial Surgery .................................................... Orthopedic Surgery .............................................................. Other .................................................................................... Otolarngology ....................................................................... Pathology ............................................................................. Pediatrics ............................................................................. Physical Medicine ................................................................ Physical/Occupational Therapy ........................................... Physician Assistant .............................................................. Plastic Surgery ..................................................................... Podiatry ................................................................................ Portable X-Ray Supplier ...................................................... Psychiatry ............................................................................. Pulmonary Disease .............................................................. Radiation Oncology and Radiation Therapy Centers .......... Radiology ............................................................................. Rheumatology ...................................................................... Thoracic Surgery .................................................................. Urology ................................................................................. Vascular Surgery ................................................................. $239 1,982 68 293 6,616 754 776 728 166 342 3,489 734 3,121 482 6,207 1,754 428 2,090 197 214 1,741 646 649 10,766 868 384 149 2,188 1,529 802 50 1,242 4,060 637 5,451 1,309 67 3,741 31 1,222 1,165 61 1,107 3,950 2,438 376 1,974 99 1,187 1,714 1,765 4,907 541 357 1,738 1,141 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 ¥1 0 1 0 0 ¥1 3 3 1 ¥1 1 ¥5 0 0 0 0 0 0 0 0 ¥1 ¥2 0 0 1 1 0 0 0 0 ¥1 0 0 0 ¥1 ¥1 0 0 4 0 ¥1 0 0 ¥1 0 0 2 1 1 0 0 0 0 0 1 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 ¥1 0 1 0 0 ¥1 3 2 1 ¥1 1 ¥5 0 0 0 0 0 0 0 0 ¥1 ¥2 ¥1 0 1 2 0 0 0 0 ¥1 0 0 0 ¥1 ¥1 0 0 4 0 ¥2 0 0 ¥1 0 0 2 1 1 0 ¥1 0 0 0 1 2 Total .............................................................................. 92,733 0 0 0 0 amozie on DSK3GDR082PROD with RULES3 * Column F may not equal the sum of columns C, D, and E due to rounding. 2. CY 2019 PFS Impact Discussion a. Changes in RVUs The most widespread specialty impacts of the RVU changes are generally related to the changes to RVUs VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 for specific services resulting from the misvalued code initiative, including RVUs for new and revised codes. The estimated impacts for some specialties, including clinical psychologists, PO 00000 Frm 00194 Fmt 4701 Sfmt 4700 vascular surgery, interventional radiology, and podiatry, reflect increases relative to other physician specialties. These increases can largely be attributed to finalized increases in E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations value for particular services following the recommendations from the American Medical Association (AMA)’s Relative Value Scale Update Committee (RUC) and CMS review, increased payments as a result of finalized updates to supply and equipment pricing, and the implementation of new payment policies associated with communication technology-based services. The estimated impacts for several specialties, including diagnostic testing facilities, independent labs, pathology, and ophthalmology, reflect decreases in payments relative to payment to other physician specialties. These decreases can largely be attributed to revaluation of individual procedures reviewed by the AMA’s committee and CMS, decreased payments as a result of finalized updates to supply and equipment pricing, and continued implementation of previously finalized code-level reductions that are being phased-in over several years. We note that the estimated impacts for many specialties differ significantly relative to the estimates included in the proposed rule. These changes reflect changes between the proposed and final policies based on our consideration of public comments. We note that the most significant of these changes relates to the various elements of the proposed changes in coding and payment for office/outpatient E/M visits, none of which are being finalized for CY 2019. For independent laboratories, it is important to note that these entities receive approximately 83 percent of their Medicare revenues from services that are paid under the CLFS. As a result, the estimated 2 percent reduction for CY 2019 is only applicable to approximately 17 percent of the Medicare payment to these entities. We often receive comments regarding the changes in RVUs displayed on the specialty impact table (Table 94), including comments received in response to the proposed rates. We remind stakeholders that although the estimated impacts are displayed at the specialty level, typically the changes are driven by the valuation of a relatively small number of new and/or potentially misvalued codes. The percentages in Table 94 are based upon aggregate estimated PFS allowed charges summed across all services furnished by physicians, practitioners, and suppliers within a specialty to arrive at the total allowed charges for the specialty, and compared to the same summed total from the previous calendar year. Therefore, they are averages, and may not necessarily be representative of what is happening to the particular services furnished by a single practitioner within any given specialty. b. Impact Column F of Table 94 displays the estimated CY 2019 impact on total allowed charges, by specialty, of all the RVU changes. A table showing the estimated impact of all of the changes on total payments for selected high volume procedures is available under ‘‘downloads’’ on the CY 2019 PFS final rule website at https://www.cms.gov/ Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeeSched/. We selected these procedures for sake of illustration from among the procedures 60029 most commonly furnished by a broad spectrum of specialties. The change in both facility rates and the nonfacility rates are shown. For an explanation of facility and nonfacility PE, we refer readers to Addendum A on the CMS website at https://www.cms.gov/ Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeeSched/. c. Estimated Impacts of Implementing the Payment and Coding Changes for Office/Outpatient E/M Services for CY 2021 Although we are not finalizing changes to E/M coding and payment for CY 2019, we are finalizing certain changes for CY 2021. We provide the following impact estimate only for illustrative purposes. Table 95 illustrates the estimated specialty level impacts associated with implementing our finalized policies for E/M coding and payment in CY 2019, rather than delaying until CY 2021. Table 24C shows the estimated impacts of adopting single payment rates for new and established patient E/M visit levels 2–4 (with the rates determined using input values that reflect the weighted average of 2018 inputs for codes describing those visit levels), keeping separate rates for new and established patient E/M visit level 5 (with the rates determined using the 2018 input values for level 5 visits), and adopting add-on codes with equal rates to adjust for the inherent visit complexity of primary care and non-procedural specialty care (with the rates determined using the input values from the proposed rule for the non-procedural specialty care complexity code). amozie on DSK3GDR082PROD with RULES3 TABLE 95—ESTIMATED SPECIALTY LEVEL IMPACTS OF FINAL E/M PAYMENT AND CODING POLICIES IF IMPLEMENTED FOR 2019 Specialty Allowed charges (mil) Impact of work RVU changes % Impact of PE RVU changes % Impact of MP RVU changes % Combined impact % (A) (B) (C) (D) (E) (F) Allergy/Immunology .............................................................. Anesthesiology ..................................................................... Audiologist ............................................................................ Cardiac Surgery ................................................................... Cardiology ............................................................................ Chiropractor ......................................................................... Clinical Psychologist ............................................................ Clinical Social Worker .......................................................... Colon and Rectal Surgery ................................................... Critical Care ......................................................................... Dermatology ......................................................................... Diagnostic Testing Facility ................................................... Emergency Medicine ........................................................... Endocrinology ...................................................................... Family Practice .................................................................... Gastroenterology .................................................................. General Practice .................................................................. General Surgery ................................................................... VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00195 $239 1,981 68 294 6,618 754 776 728 166 342 3,486 733 $3,121 482 6,208 1,757 429 2,093 Fmt 4701 Sfmt 4700 0 ¥1 ¥1 ¥1 ¥1 ¥1 ¥1 ¥2 0 ¥2 1 0 ¥2 ¥1 1 ¥2 2 0 E:\FR\FM\23NOR3.SGM 0 0 1 ¥1 ¥1 0 1 2 1 ¥1 3 ¥5 ¥1 ¥1 1 ¥1 1 0 23NOR3 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 ¥2 0 ¥2 ¥2 ¥1 0 0 0 ¥3 4 ¥5 ¥2 ¥2 2 ¥3 3 ¥1 60030 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations amozie on DSK3GDR082PROD with RULES3 TABLE 95—ESTIMATED SPECIALTY LEVEL IMPACTS OF FINAL E/M PAYMENT AND CODING POLICIES IF IMPLEMENTED FOR 2019—Continued Specialty Allowed charges (mil) Impact of work RVU changes % Impact of PE RVU changes % Impact of MP RVU changes % Combined impact % (A) (B) (C) (D) (E) (F) Geriatrics .............................................................................. Hand Surgery ....................................................................... Hematology/Oncology .......................................................... Independent Laboratory ....................................................... Infectious Disease ................................................................ Internal Medicine .................................................................. Interventional Pain Mgmt ..................................................... Interventional Radiology ...................................................... Multispecialty Clinic/Other Phys .......................................... Nephrology ........................................................................... Neurology ............................................................................. Neurosurgery ....................................................................... Nuclear Medicine ................................................................. Nurse Anes/Anes Asst ......................................................... Nurse Practitioner ................................................................ Obstetrics/Gynecology ......................................................... Ophthalmology ..................................................................... Optometry ............................................................................ Oral/Maxillofacial Surgery .................................................... Orthopedic Surgery .............................................................. Other .................................................................................... Otolarngology ....................................................................... Pathology ............................................................................. Pediatrics ............................................................................. Physical Medicine ................................................................ Physical/Occupational Therapy ........................................... Physician Assistant .............................................................. Plastic Surgery ..................................................................... Podiatry ................................................................................ Portable X-Ray Supplier ...................................................... Psychiatry ............................................................................. Pulmonary Disease .............................................................. Radiation Oncology and Radiation Therapy Centers .......... Radiology ............................................................................. Rheumatology ...................................................................... Thoracic Surgery .................................................................. Urology ................................................................................. Vascular Surgery ................................................................. 197 214 1,741 646 649 10,767 868 386 149 2,190 1,529 804 50 1,242 4,065 638 5,448 $1,309 68 3,743 31 1,210 1,165 61 1,107 3,950 2,457 377 1,974 99 1,187 1,715 1,766 4,911 541 358 1,738 1,148 ¥1 1 0 ¥1 ¥1 0 1 0 ¥1 ¥1 ¥1 ¥1 ¥1 ¥2 2 2 ¥1 0 0 0 ¥1 3 ¥1 1 ¥1 ¥1 2 0 4 0 3 ¥1 ¥1 ¥1 0 ¥1 2 0 ¥1 1 ¥1 3 ¥1 0 2 ¥2 ¥1 ¥1 0 ¥1 ¥1 0 1 2 ¥2 ¥1 0 1 3 3 ¥1 0 0 ¥2 1 0 6 0 2 ¥1 ¥1 ¥1 ¥1 ¥1 3 ¥2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 ¥1 3 0 3 ¥1 0 3 ¥2 ¥2 ¥2 ¥1 ¥1 ¥3 ¥2 3 5 ¥3 ¥1 1 1 2 5 ¥2 1 ¥2 ¥3 4 1 10 0 5 ¥2 ¥1 ¥2 ¥1 ¥2 4 ¥2 Total .............................................................................. 92,771 0 0 0 0 Under our finalized policies, specialties that disproportionately report lower level visits, such as podiatry, and specialties that report office/outpatient visits in conjunction with minor procedures, such as dermatology, would see significant increases. Specialties that predominantly furnish higher level visits would have their negative redistribution significantly mitigated by the maintenance of the level 5 visit and the add-on codes for inherent visit complexity for primary and nonprocedural specialty care. We note that our original proposal was developed more generally to maintain overall RVUs within the codes describing office/outpatient visits, but, after consideration of public comments, we are not finalizing several elements of VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 those proposals, including and especially the multiple procedure payment reduction. As a result, implementation with the values and policies as altered, would require offsetting reductions in overall PFS payments. Following our current methodology, these reductions, required by statute, would be applied through a budget neutrality adjustment in the PFS CF, consistent with our established methodology. As a result of such an adjustment, specialties that do not furnish office/outpatient visits generally would see overall reductions in payment of approximately 2.0 percent, as generally reflected in the Table 95. Given that overall payment for the office/outpatient E/M codes would increase, and because these services are reported by most specialities, the overall PO 00000 Frm 00196 Fmt 4701 Sfmt 4700 changes for most specialties are generally offsetting. However, for physician specialties and suppliers that do not report office/outpatient E/M services, the reduction would be approximately ¥2.0 percent. As discussed in section II.H., of this final rule, based on the statements by commenters that the medical community, through the CPT process, has committed itself to considering revisions to the office/outpatient visit codes and given the history of collaboration between CMS and the medical community, we expect to consider any possible changes in CPT coding, as well as recommendations regarding valuation for services, from the RUC and other stakeholders, through our annual rulemaking process, between now and implementation for E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations CY 2021. We note that any potential coding changes, and recommendations in overall valuation for new or existing codes, could have significant impact on the actual change in overall RVUs for office/outpatient visits relative to the rest of the PFS. Given the various factors that will be considered by the variety of stakeholders involved in the CPT and RUC processes, we do not believe we can estimate with any degree of certainty what the impact of potential changes might be. We also, note, however, that any changes in coding and payment for these services would be subject to notice and comment rulemaking. With regard to the documentation policies we are finalizing for CY 2021, our intent is to allow clinicians a choice in how levels 2 through 5 visits are documented—using current framework, MDM or time. Assuming the current code set for E/M office/outpatient visits is maintained for CY 2021, when a level 2 through 4 visit (which comprises the majority of visits currently furnished) is documented using the current framework or MDM, documentation will be simplified by applying a minimum level 2 documentation standard to level 2 through 4 visits. When a level 2 through 4 visit is documented using time, practitioners should report the appropriate code based on the time defined as typical under the CPT code descriptors for office/outpatient E/M visits. Practitioners will be required to document that the visit was medically necessary and the billing practitioner spent at least the amount of time included in the CPT as typical face-toface with the patient. The extended visit code can be reported with a level 2 through 4 visit when the time of the overall visit is between 34 and 69 minutes (for established patients) and between 38 and 89 minutes (for new patients) of face-to-face time with the billing practitioner. (See section II.I. of this final rule. For example, a level 2 through 4 extended visit will require the billing practitioner to spend and document that he or she spent at least 35 minutes face-to-face with the patient. We are also finalizing a policy to require minimal documentation to support reporting of the add-on codes that we are finalizing for use with the level 2 through 4 visit codes. These add-on codes are to reflect the inherent complexity in E/M services for primary care, and for other non-procedural specialty care, and for extended visits). For level 5 E/M visits, again assuming the current code set remains in place for CY 2021, we will allow the visit to be documented using the current framework, MDM or time. When VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 documenting using MDM, the current definition of level 5 MDM will apply. When documenting a level 5 visit using time, we will require the billing practitioner to document that they spent at least the typical time for the reported level 5 CPT code, face-to-face with the patient (currently 40 minutes for an established patient and 60 minutes for a new patient). The add-on codes that we are finalizing for use with the level 2 through 4 visits (the inherent complexity add-on codes for primary care and other non-procedural specialty care and extended visits) will not be reportable with level 5 visits. We note that the current coding for prolonged visits would continue to be reportable with level 5 visits. As discussed elsewhere in this section of the final rule, we estimate this approach would lead to significant burden reduction for practitioners, while allowing preparatory time and time for potential refinement over the next few years as we take into account any feedback from stakeholders on these changes, as well as any potential revisions to the E/M code set. D. Effect of Changes Related to Telehealth As discussed in section II.D. of this final rule, we are adding two new codes, HCPCS codes G0513 and G0514, to the list of Medicare telehealth services. Although we expect these changes to have the potential to increase access to care in rural areas, based on recent telehealth utilization of services already on the list, including services similar to the proposed additions, we estimate there will only be a negligible impact on PFS expenditures from these additions. For example, for services already on the list, they are furnished via telehealth, on average, less than 0.1 percent of the time they are reported overall. This addition was responsive to longstanding stakeholder interest in expanding Medicare payment for telehealth services. The restrictions placed on Medicare telehealth by the statute limit the magnitude of utilization; however, we believe there is value in allowing physicians and patients the greatest flexibility when appropriate. E. Effect of Changes to Payment to Provider-Based Departments (PBDs) of Hospitals Paid Under the PFS As discussed in section II.G. of this final rule, we are finalizing a PFS Relativity Adjuster of 40 percent for CY 2019, meaning that nonexcepted items and services furnished by nonexcepted off-campus PBDs will be paid under the PFS at a rate that is 40 percent of the OPPS rate. In finalizing our policy to PO 00000 Frm 00197 Fmt 4701 Sfmt 4700 60031 maintain the PFS Relativity Adjuster at 40 percent, we updated our analysis to include a full year of claims data. We estimated site-specific PFS rates for the technical component of a service for the entire range of HCPCS codes furnished in nonexcepted off campus PBDs. Next we compared the sum of the sitespecific payment rates under the PFS, weighted by OPPS claims volume, to the sum of payment rates under the OPPS, also weighted by OPPS claims volume. This calculation resulted in a relative rate of approximately 40 percent, supporting our policy to maintain the PFS Relativity Adjuster at 40 percent. We are finalizing the PFS Relativity Adjuster of 40 percent, as proposed. There will be no additional savings for CY 2019 relative to CY 2018 because we are maintaining the current PFS Relativity Adjuster of 40 percent, which was finalized for CY 2018. F. Other Provisions of the Final Regulation 1. Part B Drugs: Application of an AddOn Percentage for Certain Wholesale Acquisition Cost (WAC)-Based Payments In section II.M. of this final rule, we finalized the following policy: Effective January 1, 2019, Wholesale Acquisition Cost (WAC)-based payments for Part B drugs made under section 1847A(c)(4) of the Act will utilize a 3 percent addon in place of the 6 percent add-on that is currently being used. We also will permit Medicare Administrative Contractors (MACs) to use an add-on percentage of up to 3 percent for WACbased payments for new drugs. We anticipate that the reduction to the add-on payment made for a subset of Part B drugs will result in savings to the Medicare program. The 3 percent add-on is consistent with MedPAC’s analysis and recommendations, as well as discounts observed by MedPAC in their June 2017 Report to the Congress. We have also considered how CMS’ experience with WAC-based pricing for recently marketed new drugs and biologicals compares to MedPAC’s findings. Although the number of new drugs that are priced using WAC is very limited, the average difference between WAC and Average Sales Price (ASP)based payment limits for a group of 3 recently approved drugs and biologicals that appeared on the ASP Drug Pricing Files (including one biosimilar biological product) was 9.0 percent. Excluding the biosimilar biological product results in a difference of 3.5 percent. The difference was determined by comparing a partial quarter WACbased payment amount determined E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 60032 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations under section 1847A(c)(4) of the Act to the next quarter’s ASP-based payment amount. These findings are in general agreement with MedPAC’s findings. Although we are able to provide examples of the relative differences between ASP and WAC based payment limits, and we anticipate some savings from the change in policy, we cannot estimate the magnitude of savings over time because we cannot determine how many new drugs and biologicals subject to partial quarter pricing will appear on the ASP Drug Pricing files in the future or how many Part B claims for these products will be paid. This limitation also applies to contractor-priced drugs and biologicals that have HCPCS codes and are in their first quarter of sales. Finally, the claims volume for contractor-priced drugs and biologicals that are billed using miscellaneous or Not Otherwise Classified codes, such as J3490 and J3590, cannot be quantified. We would like to note that for the three drugs discussed in the preceding paragraph, Medicare Part B payments for individual doses of each drug range from approximately $3,000 to $10,000. The payment changes finalized in this rule would result in a little less than $100 to $300 savings in Medicare allowed charges for each dose. Although we cannot estimate the overall savings to the Medicare Program or to beneficiaries, we would like to note that this change in policy is likely to decrease copayments for individual beneficiaries who are prescribed new drugs. Given that launch prices for single doses for some new drugs may range from tens to hundreds of thousands of dollars, a 3 percentage point reduction in the total payment allowance will reduce a patient’s 20 percent Medicare Part B copayment. This reduction can result in savings to an individual beneficiary and can help Medicare beneficiaries particularly those without supplementary insurance, afford to pay for new drugs by reducing out of pocket expenses. The 3 percent add-on is expected to reduce the difference between acquisition cost and certain WAC-based Part B drug payments. Based on MedPAC’s June 2017 Report to Congress, and for reasons discussed in section II.M. of this rule, we do not anticipate that this change will result in payments amounts that are below acquisition cost or that the new policy will impair providers or patients’ access to Part B drugs. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 2. Changes to the Regulations Associated With the Ambulance Fee Schedule As discussed in section III B.2. of this final rule, section 50203(a) of the Bipartisan Budget Act of 2018 amended section 1834(l)(12)(A) and (l)(13)(A) of the Act to extend the payment add-ons set forth in those subsections through December 31, 2022. The ambulance extender provisions are enacted through legislation that is self-implementing. A plain reading of the statute requires only a ministerial application of the mandated rate increase and does not require any substantive exercise of discretion on the part of the Secretary. As a result, there were no policy proposals associated with these legislative provisions or associated impact in this rule. We are finalizing our proposal without modification to revise the dates in § 414.610(c)(1)(ii) and (c)(5)(ii) to conform the regulations to these self-implementing statutory requirements. In addition, as discussed in section III.B.3. of this final rule, section 53108 of the BBA amended section 1834(l)(15) of the Act to increase the payment reduction from 10 percent to 23 percent effective for ambulance services furnished on or after October 1, 2018 consisting of non-emergency basic life support services involving transports of an individual with end stage renal disease for renal dialysis services furnished other than on an emergency basis by a provider of services or a renal dialysis facility. The 10 percent reduction applies for such ambulance services furnished during the period beginning on October 1, 2013 and ending on September 30, 2018. This statutory requirement is selfimplementing. A plain reading of the statute requires only a ministerial application of the mandated rate decrease and does not require any substantive exercise of discretion on the part of the Secretary. As a result, there were no policy proposals associated with these legislative provisions or associated impact in this rule. We are finalizing our proposal without modification to revise § 414.610(c)(8) to conform the regulations to this selfimplementing statutory requirement. 3. Clinical Laboratory Fee Schedule: Change to the Majority of Medicare Revenues Threshold in Definition of Applicable Laboratory As discussed in section III. A. of this final rule, section 1834A of the Act, as established by section 216(a) of the Protecting Access to Medicare Act of 2014 (PAMA), required significant PO 00000 Frm 00198 Fmt 4701 Sfmt 4700 changes to how Medicare pays for Clinical Diagnostic Laboratory Tests (CDLTs) under the Clinical Laboratory Fee Schedule (CLFS). The CLFS final rule titled, Medicare Clinical Diagnostic Laboratory Tests Payment System final rule, published in the Federal Register on June 23, 2016, implemented section 1834A of the Act. Under the CLFS final rule (81 FR 41036), ‘‘reporting entities’’ must report to CMS during a ‘‘data reporting period’’ ‘‘applicable information’’ (that is, certain private payor data) collected during a ‘‘data collection period’’ for their component ‘‘applicable laboratories.’’ In general, the payment amount for each CDLT on the CLFS furnished beginning January 1, 2018, is based on the applicable information collected during the 6month data collection period and reported to us during the 3-month data reporting period, and is equal to the weighted median of the private payor rates for the CDLT. An applicable laboratory is defined at § 414.502, in part, as an entity that is a laboratory (as defined under the Clinical Laboratory Improvement Amendments (CLIA) definition at § 493.2) that bills Medicare Part B under its own National Provider Identifier (NPI). In addition, an applicable laboratory is an entity that receives more than 50 percent of its Medicare revenues during a data collection period from the CLFS and/or the PFS. We refer to this component of the applicable laboratory definition as the ‘‘majority of Medicare revenues threshold.’’ The definition of applicable laboratory also includes a ‘‘low expenditure threshold’’ component which requires an entity to receive at least $12,500 of its Medicare revenues from the CLFS during a data collection period, for its CDLTs that are not advanced diagnostic laboratory tests (ADLTs). In determining payment rates under the private payor rate-based CLFS, one of our objectives is to obtain as much applicable information as possible from the broadest possible representation of the national laboratory market on which to base CLFS payment amounts, for example, from independent laboratories, hospital outreach laboratories, and physician office laboratories, without imposing undue burden on those entities. We believe it is important to achieve a balance between collecting sufficient data to calculate a weighted median that appropriately reflects the private market rate for a CDLT, and minimizing the reporting burden for entities. In response to stakeholder feedback and in the interest of facilitating this objective, we are finalizing the revision to the majority of E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations Medicare revenues threshold component in the third paragraph of the definition of applicable laboratory at § 414.502 to exclude Medicare Advantage (MA) payments under Medicare Part C from the definition of total Medicare revenues (that is, the denominator of the majority of Medicare threshold equation). We believe this change would increase the opportunity for laboratories with a significant Medicare Part C revenue component to meet the majority of Medicare revenues threshold and qualify as an applicable laboratory (provided all other requirements for applicable laboratory status are met). We believe this will result in a broader representation of the laboratory industry reporting applicable information from which to determine payment rates under the CLFS. For a complete discussion of this revision to the majority of Medicare revenues threshold component of the definition of applicable laboratory under the Medicare CLFS, we refer readers to section III A. of this final rule. Therefore, in response to stakeholder feedback and in the interest of obtaining as much applicable information as possible, we are finalizing the revision of the definition of applicable laboratory at § 414.502 to include a hospital laboratory that bills Medicare on the Form CMS–1450 14x bill type and its electronic equivalent. For a complete discussion of this revision to the definition of applicable laboratory under the Medicare CLFS, we refer readers to section III.A. of this final rule. a. Estimation of Increased Reporting To estimate the potential impact of excluding MA plan payments from total Medicare revenues (that is, the denominator of the low expenditure threshold) on the number of laboratories meeting the majority of Medicare revenues threshold, using CY 2017 Medicare claims data, we compared the number of billing NPIs that would have met the majority of Medicare revenues threshold with MA plan revenues included in total Medicare revenues (which is the current requirement) versus the number of billing NPIs that would meet the majority of Medicare revenues threshold had MA plan payments been excluded from total Medicare revenues. We found that excluding MA plan payments from total Medicare revenues increased the level of laboratories meeting the majority of Medicare revenues threshold by approximately 49 percent. In other words, we estimate that excluding MA plan payments from total Medicare revenues (the denominator) of the majority of Medicare revenues threshold, and keeping the numerator constant (that is revenues from only the CLFS and or PFS) yields an increase of 49 percent in the number of laboratories meeting the majority of Medicare revenues threshold. 60033 Our summary analysis of data reporting from the initial data reporting period under the Medicare CLFS private payor rate-based payment system, indicates that we received applicable information from 1,942 applicable laboratories and they reported over 4.9 million records. Applying the projected 49 percent increase to the number of applicable laboratories from the first data reporting period (1,942 × 1.49) yields an estimated 2,893 laboratories that would meet the majority of Medicare revenues threshold, which reflects an additional 951 laboratories. Provided all other requirements for applicable laboratory status are met (including the low expenditure threshold of receiving at least $12,500 in CLFS revenues during a data collection period) a laboratory would report applicable information for the next data reporting period. To determine the estimated reporting burden for an applicable laboratory, we looked at the distribution of reported records that occurred for the first data reporting period. The average number of records reported for an applicable laboratory for the first data reporting period was 2,573. The largest amount of records reported for an applicable laboratory was 457,585 while the smallest amount reported was 1 record. A summary of the distribution of reported records from the first data collection period is illustrated in the Table 96. TABLE 96—SUMMARY OF RECORDS REPORTED FOR FIRST DATA REPORTING PERIOD amozie on DSK3GDR082PROD with RULES3 [By applicable laboratory] Percentile distribution of records Total records Average records Min records Max records 10th 25th 50th 75th 90th 4,995,877 2,573 1 457,585 23 79 294 1,345 4,884 Presuming that all of the additional laboratories that are projected to meet the majority of Medicare revenues threshold, that is approximately 951, also meet all of the criteria necessary to receive applicable laboratory status, as defined at § 414.502, they would be an applicable laboratory and report applicable information for the next data reporting period, January 1, 2020 through March 31, 2020. Using the midpoint of the percentile distribution of reported records from the initial data reporting period, that is approximately 300 records reported per applicable laboratory (50th percentile for the first data reporting period was 294), we estimate an additional 285,300 records would be reported for the next data VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 reporting period (951 laboratories × 300 records per laboratory = 285,300). This represents an increase in data reporting of about 5 percent over the number of records reported for the initial data reporting period (285,300 additional records/4,995,877 = 0.05). In other words, using the approximate mid-point of reported records for the first data reporting period, we estimate that our proposed change to the majority of Medicare revenues threshold would increase the total amount of records reported by approximately 5 percent. As illustrated in Table 96, the number of records reported varies greatly, depending on the volume of services performed by a given laboratory. Laboratories with larger test volumes, PO 00000 Frm 00199 Fmt 4701 Sfmt 4700 for instance at the 90th percentile, should expect to report more records as compared to the midpoint used for this analysis. Laboratories with smaller test volume, for instance at the 10th percentile, should expect to report fewer records as compared to the midpoint. We estimate that the inclusion of 14X type of bills would yield an increase of 39 percent in the total number of laboratories meeting the majority of Medicare revenues threshold. Applying the projected 39 percent increase to the number of applicable laboratories from the first data reporting period (1,942 × 1.39) yielded an estimated 2,699 laboratories that would meet the majority of Medicare revenues threshold, which reflects approximately E:\FR\FM\23NOR3.SGM 23NOR3 60034 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations amozie on DSK3GDR082PROD with RULES3 757 additional laboratories. Provided all other required criteria for applicable laboratory status are met (including the low expenditure threshold of receiving at least $12,500 in CLFS revenues during a data collection period) a laboratory would report applicable information for the next data reporting period. Using the mid-point of the percentile distribution of reported records from the initial data reporting period, that is approximately 300 records reported per applicable laboratory (50th percentile for the first data reporting period was 294), we estimated an additional 221,100 records would be reported for the next data reporting period (757 laboratories × 300 records per laboratory = 227,100). This represents an increase in data reporting of about 5 percent over the number of records reported for the initial data reporting period (227,100 additional records/4,995,877 = 0.05). b. Minimal Impact Expected on CLFS Rates We note that there would only be an associated Medicare cost or savings to the extent that the additional applicable laboratories are paid at a higher or lower private payor rate, as compared to other laboratories that reported previously, and only to the extent that the volume of services performed by these ‘‘additional’’ applicable laboratories is significant enough to make an impact on the weighted median of private payor rates. We have no reason to believe that increasing the level of participation, either by excluding MA plan payments from total Medicare revenues or including laboratories that bill Medicare Part B on the Form CMS–1450 14x bill type would result in a measurable cost difference under the CLFS. Given that the largest laboratories with the highest test volumes, by definition, dominate the weighted median of private payor rates, and that the largest laboratories reported data for the determination of CY 2018 CLFS rates and are expected to report again, we do not expect the additional reported data resulting from our proposed change to the majority of Medicare revenues threshold to have a predictable, direct impact on CLFS rates because of the reasons stated above. However, we believe that this proposal responds directly to stakeholder concerns regarding the number of applicable laboratories reporting applicable information for the initial data reporting period. Therefore, in an effort to increase the number of laboratories qualifying for applicable laboratory status, we are finalizing a change to the majority of Medicare revenues threshold so that laboratories VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 furnishing tests to a significant level of Medicare Part C enrollees may qualify as applicable laboratories and report data to us. In addition, as part of the same effort to increase the number of laboratories qualifying for applicable laboratory status, we are finalizing a change in the definition of applicable laboratory to include an entity that bills Medicare Part B on the Form CMS–1450 14x bill type. We note that other laboratory types, such as independent laboratories and physician office laboratories, are required under the current definition of an applicable laboratory to determine applicable laboratory status and must report applicable information. The use of Form CMS–1450 14x TOB to define an applicable laboratory would assist hospital outreach laboratories to comply with their obligation to assess applicable laboratory status for any outreach laboratories and report applicable information if they meet the requirements to be an applicable laboratory. As such, the hospital could use the revenues from the CLFS and PFS as the numerator compared to the total revenues for the 14X TOB to determine applicable laboratory status. Alternatively, a hospital could get an NPI for its outreach laboratory. Comment: One commenter disagreed with our using the number of laboratories reporting applicable information during the first data reporting period as a baseline for estimating the number of additional laboratories that would report applicable information as a result of excluding MA plan payments under Part C from total Medicare revenues. The commenter stated that because the OIG estimated that 5 percent of all laboratories paid under Medicare Part B, or about 12,500 laboratories, would qualify as applicable laboratories and would be required to report applicable information to CMS. The commenter stated that because the OIG’s estimate is far greater than the number of laboratories that actually reported (that is 1,942), we should not have used the number of laboratories reporting applicable information during the first data reporting period as a baseline. Response: We believe that it is more appropriate to use the actual reporting levels (1,942 laboratories) from the initial data reporting period as a baseline for projecting increased data reporting under our final policy rather than an estimation of laboratories determined as applicable. We acknowledge that the OIG estimated that 5 percent of all laboratories paid under Medicare Part B, or about 12,500 laboratories, would qualify as applicable PO 00000 Frm 00200 Fmt 4701 Sfmt 4700 laboratories. It is important to note that individual laboratories determine whether they meet the requirements to be an applicable laboratory and that neither OIG nor CMS had the benefit of experience with collecting private payor data before those estimates were made. We believe that using the actual number of laboratories that reported is the more reliable method to develop our estimates of future potential applicable laboratories. We believe that it is would be inappropriate here to estimate future changes using an estimate as a baseline when there is actual experience (for example, number of reporters) that can base used as a baseline. 4. Appropriate Use Criteria for Advanced Diagnostic Imaging Services Section 1834(q)(2) of the Act, as added by section 218(b) of the PAMA, established a program to promote the use of AUC for applicable imaging services furnished in an applicable setting. The CY 2016 PFS final rule with comment period established an evidence-based process and transparency requirements for the development of AUC and stated that the AUC development process requirements, as well as the application process that organizations must comply with to become qualified provider-led entities (PLEs) did not impact CY 2016 physician payments under the PFS (80 FR 71362). The CY 2017 PFS final rule identified the requirements clinical decision support mechanisms (CDSMs) must meet for qualification and stated that the CDSM requirements, as well as the application process that CDSM developers must comply with for their mechanisms to be specified as qualified under this program, did not impact CY 2017 physician payments under the PFS (81 FR 80546). The CY 2018 PFS final rule established the effective date of January 1, 2020, on which the AUC consulting and reporting requirements will begin, and extended the voluntary consulting and reporting period to 18 months. Therefore, we stated these proposals did not impact CY 2018 physician payments under the PFS (82 FR 53349) and noted we would provide an impact statement when applicable in future rulemaking. This final rule modifies the Medicare AUC Program and addresses the impacts related to the actions taken by ordering professionals who order advanced diagnostic imaging services and those who furnish the advanced diagnostic imaging services, including the professional and technical portions of the services. We finalized a modification to the AUC consultation requirement for ordering professionals E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations amozie on DSK3GDR082PROD with RULES3 specified in our regulation at § 414.94(j) to allow clinical staff under the direction of the ordering professional to perform the AUC consultation; therefore, this analysis estimates the impact of AUC consultations. We also clarified the requirement that reporting AUC consultation information across claims for both the furnishing professional and furnishing facility is required in § 414.94(k), and this analysis estimates the impact of the statutorily required reporting AUC consultation information. In addition, we modified the significant hardship exceptions in § 414.94(i) as proposed, therefore this analysis estimates the impact of a selfattestation process for ordering professionals. We also estimated the further reaching impacts of the AUC program in the detailed analysis that follows, assuming that some ordering professionals will voluntarily choose to purchase a qualified CDSM integrated within their existing electronic health record (EHR) and others may voluntarily choose to purchase an EHR system in order to obtain an integrated qualified CDSM. We believe that in the beginning of this program due to the additional action required on the part of the ordering professional, it may take longer for a Medicare beneficiary to obtain an order for an advanced diagnostic imaging service, and therefore, we have calculated an estimated impact to Medicare beneficiaries. This final rule includes a discussion of the proposed options along with the final policy to report the required claims-based AUC consultation information in the form of G-codes and HCPCS modifiers. We estimated the impact to use existing coding methods (G-codes and HCPCS modifiers) to report that information. Finally, we measured the estimated impact on furnishing professionals and facilities of the finalized proposal to include independent diagnostic testing facilities (IDTFs) as an applicable setting in § 414.94(b). While the AUC consultation and reporting requirements of this program are effective beginning January 1, 2020 with an educational and operations testing period, we attempt in this analysis to identify areas of potential qualitative benefits to both Medicare beneficiaries and the Medicare program. a. Impact of Required AUC Consultations by Ordering Professionals In this final rule, we modified the AUC program largely in response to public comments and recommendations as we believe these modifications are also important in minimizing burden of the AUC program on ordering VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 professionals, furnishing professionals, and facilities. Specifically, we included a proposal regarding who, other than the ordering professional, may conduct the AUC consultation through a qualified CDSM and still meet the requirements of our regulations. In the CY 2018 PFS final rule (82 FR 53349), we based our estimate for the AUC consultation requirement on the 2 minute effort of a family and general practitioner resulting in an annual burden of 1,425,000 hours (43,181,818 consultations (Part B analytics 2014 claims data) × 0.033 hr/ consultation) at a cost of $275,139,000. An important difference from last year’s analysis is that this year’s analysis includes estimates for nonphysician practitioners that order advanced diagnostic imaging services. For the purposes of this analysis, we assumed that orders for advanced diagnostic imaging services will be placed by ordering professionals that are non-physician practitioners in the same percent as the numbers of nonphysician practitioners are relative to the total number of non-institutional providers. Therefore, this analysis assumed that 40 percent of all advanced diagnostic imaging services will be ordered by non-physician practitioners. While non-physician practitioners may not order advanced diagnostic imaging services in the same proportion as their numbers, we did not have other data to use for this estimate. We specifically solicited comment and data on alternative assumptions about the number of non-physician practitioners who order advanced imaging services. We did not receive comments on this aspect of our estimate. In addition, we had proposed, but did not finalize, that auxiliary personnel may perform the AUC consultation when under the direction of, and incident to, the ordering professional’s services. We finalized that the AUC consultation task may be delegated by the ordering professional to clinical staff under the direction of the ordering professional. The final estimate below, after taking into account public comments, is applicable given the change in policy from proposed rule to final rule. In the CY 2019 PFS proposed rule, we estimated that the majority, or as many as 90 percent, of practices will employ the use of auxiliary personnel, working under the direction of the ordering professional, to interact with the CDSM for AUC consultation for advanced diagnostic imaging orders. We also considered leaving the policy unchanged, and smaller modifications to that could expand who performs the consultation to a single type of nonphysician practitioner. We originally PO 00000 Frm 00201 Fmt 4701 Sfmt 4700 60035 proposed this modification because we believed it maximized burden reduction effort as illustrated in the following updated estimate of consultation burden. To estimate the burden of this proposed policy, we calculated the effort of a 2-minute consultation with a qualified CDSM by a registered nurse (occupation code 29–1141) with mean hourly wage of $35.36 and 100 percent fringe benefits to be $2.33/consultation ($35.36/hour × 2 × 0.033 hour). If 90 percent of AUC consultations (1,282,500 hours) are performed by auxiliary personnel as proposed then annually the burden estimate would be $90,698,400 (1,282,500 hours × $70.72/ hour) to consult. We acknowledged that some AUC consultations will be performed by the ordering professional, therefore the remaining total annual burden we estimated was $28,576,950 for the consultation requirement as it was proposed. As a result of these assumptions and calculations, we estimated a reduction in the burden of the statutorily required AUC consultation burden from $275,139,000 (as fully discussed in the CY 2018 PFS final rule) to $122,508,675, which resulted in a net burden reduction of $152,630,325. The following is a summary of the comments we received on the proposed estimated impact of consultations by ordering professionals. Comment: In general, several commenters found CMS’ proposed estimate of the burden of the Medicare AUC program to be sensible. A few commenters disagreed with the proposed burden estimate of 2 minutes to consult a qualified CDSM. One commenter suggested the time was too short and noted that the Medicare Imaging Demonstration Evaluation Report to Congress 46 indicated 3.3 additional minutes to order an advanced diagnostic imaging service, while another commenter questioned whether the estimate of burden included calculations for the time and effort of the ordering professional to look up the CDSM username and password, wait for web pages to load, conduct the AUC consultation, and record the results. Additionally, a few commenters stated that more complex clinical situations will require additional time to perform an AUC consultation, as well as consultations involving new patients with new clinical scenarios. In contrast, a few other commenters suggested that 46 Timbie JW, Hussey PS, Burgette L, et al. Medicare imaging demonstration evaluation report for the report to congress. April 2014. RR–706– CMMS. E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 60036 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations the 2 minute estimate to perform AUC consultation overestimated the time and effort, stating that accessing one no fee website for a qualified CDSM to perform an AUC consultation takes a healthcare provider less than 50 seconds. Response: Based on the average of two estimates provided ([3.3 min + 0.8 min]/ 2 = 2.1 min), we continue to believe that 2 minutes is a reasonable estimate of the time and effort to consult one of the currently qualified clinical decision support mechanisms available under this program. We will continue to supplement these estimates with published evidence as the AUC consultation and reporting requirements are implemented beginning January 1, 2020. Comment: A few commenters agreed with our estimates that as many as 90 percent of practices would use other personnel working under the direction of the ordering professional to interact with the CDSM. One commenter noted that most family physicians and general practitioners would not employ a registered nurse for the purpose of AUC consultation and instead would rely upon a licensed practical nurse or medical assistant. The commenter also noted that we are likely overestimating the costs in question because if CMS anticipates a registered nurse is needed, then such a professional would be cost prohibitive for most family medicine practices. Response: As a result of the finalized policy at § 414.94(j) and after reading the public comments, we have updated our estimate to account for the $16.15 mean hourly wage and fringe benefits of a medical assistant (BLS #31–9092) to perform the AUC consultation. If 90 percent of consultations (1,282,500 hours) are performed by such an individual then annually the burden estimate would be $41,424,750 (1,282,500 hours × $32.30/hour) to consult. Comment: One commenter suggested that not all clinical situations will require the ordering professional to consult a CDSM and report the AUC adherence, but rather noted that first the ordering professional must determine if the patient’s clinical scenario is within a priority clinical area. Additionally, one commenter stated that additional time and effort should be considered to estimate the interaction that will likely be required between the ordering professional and auxiliary personnel to complete the AUC consultation within the CDSM. Finally, one commenter suggested that CMS also estimate the time and effort for the furnishing professional to perform the AUC VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 consultation on behalf of the ordering professional. Response: We remind all commenters that an AUC consultation must take place for any applicable imaging service furnished in an applicable setting and paid for under an applicable payment system, regardless of whether the patient’s clinical scenario falls within a priority clinical area. Therefore, we believe that there is not additional time and effort needed to make this determination as it does not change the estimation of burden for the AUC consultation requirement at § 414.94(j). As a result of the finalized policy at § 414.94(j), the furnishing professional cannot perform the AUC consultation on behalf of the ordering professional; therefore, we did not include this additional estimate. When the consultation and reporting requirements are implemented beginning January 1, 2020, we may have data to support additional time for other supportive consultations, such as that between clinical staff and the ordering professional. However, at this time we have no experience or data to suggest the type or time of these interactions, and did not receive estimates or experience from commenters to suggest the level of effort required to change this AUC consultation burden estimate further. Comment: A few commenters requested that CMS consider situations where multiple consultations occur for the same advanced diagnostic imaging service for the same Medicare beneficiary, such as in the case of obtaining a second opinion. One commenter expected that the estimate of burden would include calculations for the time and effort required of the ordering professional to consult more than one CDSM. Another commenter noted situations resulting in the Medicare beneficiary being unable to receive an order during the encounter and forced to return to the practice such as in the case of technical issues with a CDSM. Finally, one commenter asked that CMS consider an assumption that some ordering professionals will decide not to use a qualified CDSM and instead refer the patient to a specialist for AUC consultation. Response: If we can consider that a patient is referred to a specialist in lieu of receiving an order from their general practitioner, then we recognize that no second consultation would occur and that a specialist acting as an ordering professional may choose to delegate the AUC consultation to another individual such as someone on their clinical staff. If there are technical difficulties that result in a significant hardship for the PO 00000 Frm 00202 Fmt 4701 Sfmt 4700 ordering professional to consult specified applicable AUC, then no consultation is required and no additional time and effort to perform the consultation would take place. While multiple consultations may take place, such as in the case of consulting more than one CDSM, it is not a requirement. We will continue to look for published evidence on these experiences after the AUC consultation and reporting requirements are implemented beginning January 1, 2020. Comment: A few commenters noted that additional costs should be considered on the part of the ordering professional and/or personnel under their supervision. One commenter asked that CMS consider the time and effort to educate ordering professionals and auxiliary personnel on how to use a CDSM. Response: We agree with the commenter that we unintentionally excluded the time and effort to undertake educational training activities related to performing an AUC consultation. As a result we have included the time and effort of a general practitioner (occupation code 29–1062) with mean hourly wage of $100.27 plus 100-percent to account for fringe benefits to attend a one-time, 1.0 hour training. The hour is representative of training incurred by physicians for a single topic as part of the process of maintaining credentials. Some physicians may not need to undertake educational training activities related to this program. Others may undertake training activities in lieu of an alternative continuing education training resulting in no net increase to their training costs. If all 579,687 ordering professionals subject to this program attend a one-time, 1.0 hour training, then we estimate the total burden to be $116,250,431 ($100.27 × 2 × 1.0 hour × 579,687). We recognize that some ordering professionals may be specialists with higher mean hourly wage and other ordering professionals are not physicians (for example, nurse practitioners, physician assistants) with lower mean hourly wage, however without any additional evidence or specific estimates from commenters, we could not inform this burden estimate further. After considering the comments, we are updating the proposed impact estimate of consultations by ordering professionals. First, we modified our calculation of the effort by a registered nurse to the effort of a 2-minute consultation with a qualified CDSM by a medical assistant (occupation code 31–9092) with mean hourly wage of $16.15 and 100 percent fringe benefits E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations amozie on DSK3GDR082PROD with RULES3 for 90 percent of consultations (1,282,500 hours) to be $41,424,750 (1,282,500 hours × $32.30/hour). We acknowledged that some AUC consultations will not be performed by these individuals, therefore the remaining total annual burden we estimate is $28,576,950 (142,500 hours × $200.54/hour) for this proposed consultation requirement. As a result of these assumptions and calculations, we estimated a reduction in burden of the statutorily required consultation from cost of $275,139,000 to $70,001,700, which results in a net burden reduction of $205,137,300. In section VII.G. of this RIA, Alternatives Considered, we provide a detailed estimate of the burden of an ordering professional voluntarily choosing to consult a second, free CDSM for 300,717 services annually. If 90 percent of those consultations (300,717 services × 90 percent × 0.033 hr/service) for 8,931.285 total hours were performed by a medical assistant at a rate of $32.30/hour for a total of $288,480.50 (8,931.285 × $32.30/hour) and 10 percent of consultations (300,717 services × 10 percent × 0.033 hr/service) for 992.376 total hours were performed by the ordering professional at a rate of $200.54/hour for a total of $199,011.08 then annually the burden estimate would be 9,923.661 total hours (8,931.285 hours + 992.376 hours) and $487,491.58 ($288,480.50 + $199,011.08) to perform the second consultation. We also estimated the burden of this one-time effort to undertake educational training activities related to the impact of consultations by ordering professionals. As a result we have included the time and effort of a general practitioner (occupation code 29–1062) with mean hourly wage of $100.27 plus 100-percent to account for fringe benefits to attend a one-time, 1.0 hour training. Based on our proposed estimate in section VII.F.4.b. of this RIA, if 579,687 ordering professionals are subject to this program, and all attend training for the same amount of time, then we estimate the total one-time burden of education and training to be $116,250,431 ($200.54/hr × 1.0 hour × 579,687). Since not all physicians would undertake educational training activities, this estimate should be considered an upper bound. b. Impact of Significant Hardship Exceptions for Ordering Professionals We previously identified significant hardship exceptions to the requirement that ordering professionals consult specified applicable AUC when ordering applicable imaging services (81 VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 FR 80170). Our original intention was to design the AUC hardship exception process in alignment with the EHR Incentive Program and then the MIPS ACI performance category (now Promoting Interoperability). However, in this final rule, we modified the significant hardship exception criteria under § 414.94(i)(3) to be specific to the Medicare AUC program and independent of other Medicare programs both in policy and process. Specifically, we finalized the policy that all ordering professionals self-attest if they are experiencing a significant hardship at the time of placing an advanced diagnostic imaging order. Since the Medicare EHR Incentive Program has ended and we are unable to continue referring to a regulation that is no longer in effect, we did not consider leaving this policy unchanged. We also considered using a significant hardship application submission process. However, we believe that the self-attestation process maximizes burden reduction effort as illustrated in the following updated estimate of ordering professionals subject to an AUC consultation burden. To estimate the impact of our modification and create a hardship exception specific to this program we attempted to identify how many ordering professionals would be subject to this program. Medicare non-institutional Part B claims for the first 6 months of 2014 shows that for claims for an advanced diagnostic imaging service that listed an NPI for the ordering/referring provider, up to 90-percent of claims include only 18 different provider specialties. These specialties include: Emergency Medicine; Internal Medicine; Family Practice; Cardiology; Hematology/ Oncology; Orthopedic Surgery; Neurology; Urology; Physician Assistant; Nurse Practitioner; Pulmonary Disease; General Surgery; Neurosurgery; Medical Oncology; Gastroenterology; Radiation Oncology; Otolaryngology; and Diagnostic Radiology. We then used CMS data that served to create Table II.8 of the 2014 Medicare Statistics Book and were able to identify how many practitioners in each of those specialties were participating in Medicare program. Table II.8 of the 2014 Medicare Statistics Book combines many of these specialties into higher level groupings and displays the total number of practitioners participating in the Medicare program. However, we used more granular information that identifies the number of practitioners participating in the Medicare program by an individual specialty rather than PO 00000 Frm 00203 Fmt 4701 Sfmt 4700 60037 higher level groupings (table available at https://www.cms.gov/ResearchStatistics-Data-and-Systems/StatisticsTrends-and-Reports/ CMSProgramStatistics/2016/ Downloads/PROVIDERS/2016_CPS_ MDCR_PROVIDERS_6.pdf). For example, Table II.8 of the 2014 Medicare Statistics Book combines all surgeons into one category whereas we used detailed information for the individual surgical specialties of general surgery and orthopedic surgery for this estimate. Using this more specific data for the 18 specialties, we estimate the count of practitioners that will be ordering professionals under the AUC program to be 586,386. There are limitations as we do not have data on the actual number of practitioners who order advanced diagnostic imaging services because information about the ordering professional is not currently required to be included on the Medicare claim form for advanced diagnostic imaging services. In the absence of data on the breadth of professionals who would be required to consult AUC, we assumed that all professionals in the specialties listed earlier could potentially be subject to these requirements because some professionals within a specialty may order these imaging services. We specifically requested comments and data on the numbers of professionals in the specialties that actually order advanced imaging services. We did not receive comments on this estimate. With respect to the significant hardship exceptions, based on 2016 data from the Medicare EHR Incentive Program and the 2019 payment year MIPS eligibility and special status file, we estimated that 6,699 respondents in the form of eligible clinicians, groups, or virtual groups will submit a request for a reweighting to zero for the advancing care information performance category due to extreme and uncontrollable circumstances or as a result of a decertification of an EHR. For the purposes of this analysis, we cautiously estimated that each of the 6,699 respondents represents a unique ordering professional and that all respondents who experience extreme and uncontrollable circumstances or have an EHR that is decertified are ordering professionals who would selfattest to a significant hardship exception under the AUC program. Nevertheless, we have used this information to update our estimate that there are 579,687 ordering professionals subject to this program. We believe that the proposed significant hardship exception at E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 60038 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations § 414.94(i) would further reduce the burden of this program as finalized for four reasons. First, due to the availability of a significant hardship exception there will likely be fewer ordering professionals consulting specified applicable AUC. Second, the self-attestation process is a less burdensome proposal when compared to the alternative of a hardship application process that may have both regulatory impact and information collection requirements. We estimate the impact of a significant hardship exception application in section VII.G. of this RIA, Alternatives Considered. Third, any application or case-by-case determination would necessitate immediate infrastructure development by CMS directly or through one or more MACs, which adds burden and impact to this program. Finally, the proposed self-attestation process requires no verification on the part of the furnishing professional or facility required to report AUC consultation information on the Medicare claim, thus minimizing burden for both ordering professionals, furnishing professionals and facilities. While some of the efficiencies gained from a self-attestation process are qualitative in nature and difficult to measure, such as the streamlined reporting, we believe that relative to other regulatory approaches this proposal uses a least burdensome approach. We recognize that ordering professionals would store documentation supporting the selfattestation of a significant hardship. Storage of this information could involve the use of automated, electronic, or other forms of information technology at the discretion of the ordering professional. We estimated that the average time for office clerical activities associated with this task to be 10 minutes. To estimate the burden of this storage, we expected that a Bureau of Labor Statistics (BLS) occupation title 43–6013 Medical Secretary with a mean hourly rate of $17.25 and 100-percent fringe benefits would result in a calculated effort of 10 minutes of clerical work to be $5.76 ($17.25/hour × 2 × 0.167 hour). If 6,699 separate ordering professionals require that a Medical Secretary perform the same clerical activity on an annual basis, then this equates to a cost of approximately $38,596 per year. We solicited comment to inform these burden estimates. We did not receive comments on these burden estimates and have finalized these estimates as proposed. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 c. Impact of Consultations Beyond the Impact To Ordering Professionals Although we have already discussed the time and effort to consult specified applicable AUC through a qualified CDSM here and in previous rulemaking (81 FR 80170), we believe the impact of this program is extensive as it will apply to every advanced diagnostic imaging service (for example, magnetic resonance imaging (MRI), computed tomography (CT) or positron emission tomography (PET)). Therefore, we also have described in this detailed analysis the estimated impacts of AUC consultation beyond the act of consulting specified applicable AUC which would be an upper bound. (1) Transfers From Ordering Professionals to Qualified CDSMs and EHR Systems The first additional impact we identified is upstream in the workflow of the AUC consultation and represents the acquisition cost, training, and maintenance of a qualified CDSM. These tools may be modules within or available through certified EHR technology (as defined in section 1848(o)(4)) of the Act or private sector mechanisms independent from certified EHR technology or established by the Secretary. Currently, none are established by the Secretary. Additionally, for the purposes of this program, as required by statute, one or more of such mechanisms is available free of charge. For this impact analysis we will illustrate three potential scenarios as low, medium, and higher burden assessments of this consultation requirement. First, we assume that some number of ordering professionals consults a qualified CDSM available free of charge. Second, we assume that some number purchase a qualified CDSM to integrate within an existing EHR system. Third, we assume that some do not currently have an EHR system and, as a result of the statutory requirement to consult with AUC, would purchase an EHR system with an integrated qualified CDSM to consult specified applicable AUC for the purposes of this program. In the lowest estimate of burden, every AUC consultation would take place using a qualified CDSM available free of charge integrated into an EHR system and add no additional cost to the requirement in § 414.94(j) of this final rule. While we did not base this estimate on absolute behaviors by all those who have ordered advanced diagnostic imaging services, we believe it is reasonable to estimate that as many as 75 percent of an assumed annual 40,000,000 orders for advanced PO 00000 Frm 00204 Fmt 4701 Sfmt 4700 diagnostic imaging services could occur at no additional cost beyond the time and effort to perform the consultation. This may be an underestimate of orders that occur at no additional cost beyond time and effort because multiple free qualified CDSMs are available. In contrast, some ordering professionals may voluntarily choose to purchase a qualified CDSM that is integrated within their EHR. To estimate how many ordering professionals may choose to purchase an integrated qualified CDSM, we consulted the 2015 National Electronic Health Records Survey 47 (NEHRS), which is conducted by the National Center for Health Statistics (NCHS) and sponsored by the Office of the National Coordinator for Health Information Technology (ONC). NEHRS is a nationally representative mixed mode survey of office-based physicians that collects information on physician and practice characteristics, including the adoption and use of EHR systems. In the United States in 2015, 86.9 percent of office-based physicians used any EHR/EMR, with significantly higher adoption by general or family practice physicians (92.7 percent, pvalue <0.05), and slightly lower for medical non-primary care physicians (84.4 percent). Given that approximately 87 percent of office-based physicians have adopted EHR systems, we believe it is likely that the majority will prefer a qualified CDSM integrated with EHR. While we note that qualified CDSMs available free of charge are also integrated within one or more EHR systems, the following illustrative exercise estimates the time and effort to purchase, install, train, and maintain a qualified CDSM integrated into an EHR system. Since section 1834(q)(1)(c)(iii) requires that one or more free CDSMs be available, this is an illustrative exercise rather than an estimate of the burden of the statutory requirement. Again, as stated above, we do not have data on the number of clinicians who order advanced diagnostic imaging services, and we have made overarching assumptions to look at particular specialty areas that in our claims analysis order these advanced diagnostic imaging services. We assumed all individual clinicians in these specialty areas could potentially be subject to these requirements. Adding the number of clinicians in each of the specialty areas results in 586,386 ordering professionals. We also did not make a distinction between individual 47 Jamoom E, Yang N. Table of Electronic Health Record Adoption and Use among Office-based Physicians in the U.S., by State: 2015 National Electronic Health Records Survey. 2016. E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations professionals and groups, as further explained below. To calculate the impact of a single purchase, we believe based on market research that ordering professionals, either in groups or individually, would spend an estimated $15,000 for a onetime purchase of an integrated qualified CDSM, including installation and training. We assume that all of these costs are based on market research and incurred over the course of 5 years. We also assume that the $15,000 purchase would be made by each ordering professional and did not take into account the potential that a group practice might incur a discounted price per user based on the number of ordering professionals in the practice. These assumptions could significantly alter the impact estimate and we sought comment on such assumptions. Given the difficult nature of deriving these illustrative estimates based on limited data, we solicited comment and information on the preference that physicians and practitioners might have for using an integrated qualified CDSM—a free CDSM or a CDSM that is not free but integrated within an existing EHR system. Also, if purchased, whether this would be purchased at the group practice level to be made available to all clinicians in the practice for the same cost that would be incurred by a single practitioner purchasing the same qualified CDSM, and whether the cost of purchasing a CDSM would be incurred in a single year or over multiple years. For the purposes of estimating the transfer of costs from ordering professionals to qualified CDSM developers, of the estimated 579,687 practitioners that are likely subject to this program, we excluded 181,653 ordering professionals with specialties whose practitioners order on average fewer than 20 advanced diagnostic imaging services per year (physician assistant, nurse practitioner, and diagnostic radiology). The assumption is that lower volume ordering professionals would select a qualified CDSM that is free of charge. This updates the estimate to consider 398,034 ordering professionals who may purchase an integrated qualified CDSM. To this end, if we assume 346,290 (398,034 ordering professionals × 87 percent) ordering professionals already have an EHR system and 30 percent of these ordering professionals (346,290 × 30 percent, or 103,887) make this purchase for $15,000 and spend $1,000 annually to maintain their system for 5 years (initial acquisition cost in year 1 and maintenance costs in years 2–5), then the total annual cost is estimated VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 60039 to be $394,770,600 ((103,887 × $19,000)/ 5 years)). It is also reasonable to assume that some ordering professionals may not need additional training in using a qualified CDSM because the EHR Incentive Program required CDS as a core measure. In addition, the EHR Incentive Program incentivized use of computerized provider order entry (CPOE)—an electronic submission of pharmacy, laboratory, or radiology orders. To determine readiness among Medicare practitioners for these and other measures, the 2011 Meaningful Use Census 48 (RTI International, 2012) observed that those participating in the EHR Incentive Program in 2011 on average met and exceeded the established 30 percent threshold for meaningful use of CPOE in Stage 1. Analysis of the distribution of performance on these measures shows that 86 percent of eligible participants were well over the established thresholds. It is important to note that the CPOE measure had a higher threshold in Stage 2, and 60 percent of eligible participants in 2011 attested to meaningful use are already meeting this higher threshold. This report suggests that some ordering professionals may be well prepared to adopt a qualified clinical decision support mechanism, as this experience offset may yield lower costs and burden to learn to incorporate decision support into the ordering workflow through shorter training times. Additionally, some ordering professionals may voluntarily choose to purchase a certified EHR system to use a qualified CDSM already integrated within the EHR. The first estimate of capital costs for certified EHR system was identified in the first year of the EHR incentive program as an estimated cost of approximately $54,000 (75 FR 44518), which adjusted for inflation using the Consumer Price Index for All Urban Consumers (CPI–U) U.S. city average series for all items, not seasonally adjusted, represents $62,050.40 in 2018. If we assume that 346,290 ordering professionals subject to this program have adopted EHR, then we will also assume that 51,744 ordering professionals (398,034 ordering professionals × 13 percent) have not adopted an EHR system. Most physicians who have not yet invested in the hardware, software, testing, and training to implement EHRs may continue to work outside the EHR for a number of reasons—lack of standards, lack of interoperability, limited physician acceptance among their peers, maintenance costs, and lack of capital. Adoption of EHR technology necessitates major changes in business processes and practices throughout a provider’s office or facility. Business process reengineering on such a scale is not undertaken lightly. Therefore, while we cannot estimate the business decisions of all ordering professionals, we assume for the purposes of this analysis that as a result of this program some ordering professionals will purchase an EHR system in order to access a qualified CDSM that is integrated into that EHR system for the purposes of acquiring long-term process efficiencies in consulting specified applicable AUC. We do not have data on the characteristics of physicians who have not purchased an EHR system. However, for the purpose of estimating the transfer of costs from ordering professionals to EHR systems, we will assume based on research from business advisors 49 that 30 percent, or 15,523 ordering professionals (51,744 ordering professionals × 30 percent) will seek to purchase an EHR system at an estimated cost of $62,050.40 for a total one-time cost of $963,208,359.20 in EHR system and integrated qualified CDSM infrastructure. As we believe not every ordering professional in this example would purchase such infrastructure immediately, for the purposes of this estimate, we annualized this cost over 5 years to $192,641,671.84/year. We recognize that qualified CDSMs may be modules within or available through certified EHR technology (as defined in section 1848(o)(4) of the Act) or private sector mechanisms independent from certified EHR technology or established by the Secretary. We recognize that due to the limited data available to make these assumptions our estimates are likely high and we sought comment and information about these assumptions. These estimates might be viewed as an upper bound of the impact of this program beyond consultation with a free tool and note that at the time of publication there were three free tools available as indicated on the CMS website at https://www.cms.gov/ Medicare/Quality-Initiatives-PatientAssessment-Instruments/AppropriateUse-Criteria-Program/CDSM.html. 48 Vincent, A. EHR Incentive Program: 2011 Meaningful Use Census. RTI Internatoinal. November 2012. 49 McCormack M, ‘‘EHR Software Buyer Report— 2014’’ available at https://www.softwareadvice.com/ resources/ehr-buyer-report-2014/. PO 00000 Frm 00205 Fmt 4701 Sfmt 4700 E:\FR\FM\23NOR3.SGM 23NOR3 60040 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations amozie on DSK3GDR082PROD with RULES3 (2) Impact to Medicare Beneficiaries Additionally, we believe that the additional 2-minute consultation will impact the Medicare beneficiary when their advanced diagnostic imaging service is ordered by the ordering professional by introducing additional time to their office visit. To estimate this annual cost, we multiplied the annual burden of 1,425,000 hours by the BLS occupation code that represents all occupations in the BLS (00–0000) as mean hourly wage plus 100 percent fringe ($47.72/hr) for a total estimate of $68,001,000 per year. Over time, there may be process efficiencies implemented in one or more practices similar to the benefits of deploying CDS 50 (Berner, 2009; Karsh, 2009) that decrease this estimate. For example, we will assume that every time an advanced diagnostic imaging service is ordered, it is the result of a visit by a Medicare beneficiary for evaluation and management. Then, let us assume that 50 percent of practices implemented an improvement process that streamlined the AUC consultation such that Medicare beneficiaries who visited those practices spent the same amount of time in the physician’s office regardless of whether an advanced diagnostic imaging service was ordered. As a result of this improvement process in practice we could estimate such efficiency would offset the estimated burden by $34,000,500 annually. Although we could not at the time of the proposed rule identify a concrete solution, we sought comment on this detailed analysis to inform future rulemaking. The following is a summary of the comments we received on the proposed estimated impact of consultations beyond ordering professionals. Comment: Commenters responded to our solicitation for comment and information on the preference that physicians and practitioners might have for purchasing an integrated qualified CDSM. One commenter suggested that CMS did not reasonably estimate the percentage of practices that would purchase an integrated CDSM relative to using a free qualified CDSM. This commenter noted that most health systems prefer to go with a commercial product for accountability, attempted standardization, and support when a 50 Berner ES. Clinical decision support systems: State of the Art. AHRQ Publication No. 09–0069– EF. Rockville, Maryland: Agency for Healthcare Research and Quality. June 2009. Karsh B–T. Clinical practice improvement and redesign: How change in workflow can be supported by clinical decision support. AHRQ Publication No. 09–0054– EF. Rockville, Maryland: Agency for Healthcare Research and Quality. June 2009. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 system goes down or requires updating. To this end, the commenter also asked that CMS estimate the cost of maintenance to a CDSM. In contrast, another commenter asked that CMS provide additional information in the final rule as to how it arrived at the maintenance estimate of $1,000 per year for an integrated CDSM. Response: We appreciate these comments acknowledging the challenges with determining the percentage of practices that would purchase an integrated CDSM relative to using a free and non-integrated CDSM. While we did not receive any more precise information to change the estimated percent of practitioners that would purchase an integrated CDSM, we will continue to evaluate these estimates as information and published evidence becomes available once the AUC consultation and reporting requirements are implemented beginning January 1, 2020. To clarify our estimate of maintenance, we performed market research by gathering information from IT experts suggesting annualized costs between 5 percent and 10 percent of initial purchase cost. Comment: A few commenters questioned the lack of ancillary costs attributed to the estimation of using a free qualified CDSM. One commenter cited the need for internet access to use the free tool. Another commenter cited AUC conferences, town hall meetings, as well as other forms of professional education to learn about CDSM consultation. Response: We continue to believe that a free tool is a qualified CDSM available free of charge. Any ordering professional without internet access would continue to remain eligible for a significant hardship exception from performing an AUC consultation and would instead communicate to the furnishing professional their hardship. We have included updates to our estimate in this final rule to account for education and training of all ordering professionals that we estimated would be subject to this program irrespective of what qualified CDSM is used to perform the AUC consultation. After reviewing all comments, for purposes of this RIA we are finalizing our proposed estimate representing the acquisition cost, and maintenance of a qualified CDSM. However, we note that these estimates are based on multiple assumptions, which could change the estimate in significant ways, and as such may be an overestimate of burden as a free qualified CDSM is required by law. PO 00000 Frm 00206 Fmt 4701 Sfmt 4700 d. Considering the Impact of ClaimsBased Reporting In the CY 2018 PFS proposed rule (82 FR 34094), we discussed using a combination of G-codes and modifiers to report the AUC consultation information on the Medicare claim. We received numerous public comments objecting to this potential solution. In the 2018 PFS final rule, we agreed with many of the commenters that additional approaches to reporting AUC consultation information on Medicare claims should be considered, and in the opinion of some commenters, reporting unique consultation identifiers (UCIs) would be a less burdensome and preferred approach. We had the opportunity to engage some stakeholders and we understand that some commenters from the previous rule continue to be in favor of a UCI. Practically examining the workflow of an order for an advanced diagnostic imaging service before and after implementation of the Medicare AUC program, we see that in general the process remains largely unchanged. Before and after the implementation of this program, an ordering professional could employ support staff to transmit an order for an advanced diagnostic imaging service from his or her office to an imaging facility, physician office, or hospital that furnishes advanced diagnostic imaging services. After implementation of this program, the ordering professionals, furnishing professionals and facilities must adapt this existing workflow to accommodate new information not previously required on orders for advanced diagnostic imaging services. We considered leaving the policy unchanged, and we also considered writing new regulations requiring larger modifications to the form and manner by which AUC consultation information is communicated from the ordering professional to the furnishing professional or facility. However, we believe this final rule minimizes burden and maximizes efficiency by reporting through established coding methods, to include G-codes and modifiers, to report the required AUC information on Medicare claims. (1) Impact on Transmitting Order for Advanced Diagnostic Imaging Services We estimate that including AUC consultation information on the order to the furnishing professional or facility is estimated as the additional 5 minutes spent by a medical secretary (BLS #43– 6013) at a mean hourly rate of $17.25 plus 100 percent fringe to transmit the order for the advanced diagnostic E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations amozie on DSK3GDR082PROD with RULES3 imaging service. Taking into account transmissions through an EHR that could occur on the order of seconds, a facsimile transmission that could occur on the order of few minutes, or a telephone call that occur on the order of several minutes, we believe the estimate of 5 minutes is an estimate that accounts for different transmittal methods, such as through an integrated EHR system, by facsimile, or via telephone call directly to the office of the furnishing professional or facility. In aggregate, if we assume that 40,000,000 advanced diagnostic imaging services are ordered annually, then the total annual burden to communicate additional information in the order is estimated as $114,540,000 ($17.25/hr × 2 × 0.083 hr × 40,000,000 orders). (2) Impact on CDSM Developers While we did not finalize use of a UCI to report AUC consultation information, the following section remains important to understanding the impact of standardizing the UCI should we move forward with such additional modifications in the future. We believe that in considering a distinct UCI we also considered updating the requirements of a qualified CDSM in § 414.94(g)(1)(vi)(B). This would incur additional costs for the developers of these mechanisms to accommodate formatting changes if instructed by CMS. We continue to believe that participation by CDSM developers in this program is voluntary, that any considerations of proposed changes to this policy maximize benefits and minimize burden to ordering professionals and furnishing professionals and facilities. Internally, CMS has explored the possibility of using a UCI to determine feasibility, and provide a detailed estimate of costs to develop, test, and implement an update in the form and manner of the UCI generated by the CDSM. To estimate the costs to develop, test, and implement this update, we will provide a relevant case study. In 1998, the Year 2000 Information and Readiness Disclosure Act (Pub. L. 105– 271, enacted October 19, 1998) was passed to ensure continuity of operations in the year 2000. At the time of passage, millions of information technology computer systems, software programs, and semiconductors were not capable of recognizing certain dates after December 31, 1999, and without modification would read dates in the year 2000 and thereafter as if those dates represented the year 1900 or thereafter, or would have failed to process those dates entirely. The federal government had budgeted $8,300,000,000 to VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 continue processing dates in 2000 and beyond (Department of Commerce, 1999). Additional estimates to repair the date in a form and manner accommodating the year 2000 varied, but one estimate 51 from analysis of the 1998–99 budget bill of the state of California estimated $241,000,000 to repair 3,000 systems, or $80,333.33 per system, which adjusted for inflation using the CPI–U, U.S. city average series for all items, not seasonally adjusted, represents $123,775.95 per system in 2018. If all 16 qualified CDSMs performed an update to the formatting of the UCI to appear on certification or documentation of every AUC consultation, then the one-time total cost incurred by all CDSM developers would be $1,980,415.20. Although this does not represent a direct transfer of costs from CDSM developers to savings and efficiencies for ordering professionals, furnishing professionals and facilities, we do believe that as a result of such a policy modification that the ordering professional could directly communicate a single AUC UCI, and furnishing professionals and facilities can report UCI in place of identifying each individual CDSM qualified for the purposes of this program. The following is a summary of the comments we received on the proposed estimated impact of claims-based reporting. Comment: One commenter noted that there is no standardized form and manner for submitting the AUC consultation information with the order for an advanced diagnostic imaging service. This commenter observed that each imaging facility has its own way of accepting an imaging order, therefore, the commenter stated it will be burdensome for the imaging facility to coordinate accurate information for one, let alone multiple imaging services with the many ordering clinicians from whom they receive imaging orders. The commenter also stated that facilities would need to invest considerable resources to develop an appropriate workflow to comply with this policy, such as additional staff time to translate AUC consultation information into appropriate codes and modifiers for billing. Response: We appreciate this experience of order transmission as we included in the proposed rule burden estimates for the communication 51 LAO Analysis of the 1998–99 Budget Bill Information Technology Issues. Information Technology Issues Analysis of the 1998–99 Budget Bill. The Year 2000 (‘‘Y2K’’) Computer Problem. Published February 18, 1998. Accessed March 25, 2018 at https://www.lao.ca.gov/analysis_1998/info_ tech_anl98.html. PO 00000 Frm 00207 Fmt 4701 Sfmt 4700 60041 between staff of the ordering professional to those furnishing the applicable imaging service ordered in section VII.F.4.d.(1) of this RIA. We also included in section VII.F.4.e. of the proposed rule a burden estimate to account for the potential of updates to billing software to accommodate possible changes in workflow that would accommodate this policy. As we did not require in this final rule a specific form and manner standardized to transmit AUC consultation information, we did not update this area of our burden estimate in this final rule. Comment: A few commenters expected additional time estimated for communication between ordering and furnishing professionals. For example, one commenter provided the scenario of a furnishing professional or facility receiving an order for an applicable imaging service but the order does not contain AUC consultation information. In another example, a patient obtains an advanced diagnostic imaging service as part of a clinical trial protocol that does not adhere to the AUC consulted. To this end, a few commenters requested that CMS allow the work associated with the additional consultation and communication time between the ordering and furnishing physicians and their teams be separately billable for the purposes of the AUC requirement. Response: We disagree that additional time for communication between ordering professionals and those furnishing advanced diagnostic imaging services should be included for instances where AUC consultation information was not initially communicated. We remind the commenters that the estimated burden included communicating AUC consultation information for all advanced diagnostic imaging services. In other words, whether the information was initially communicated or whether there was an initial failure and the information was then subsequently communicated, that communication has been accounted in our 5 minute estimate per service. We did not propose to authorize a separately billable service by ordering or furnishing professionals or their teams to communicate and therefore cannot estimate the cost of billing Medicare for time to transmit AUC consultation information. After reviewing the comments, we are finalizing the proposed estimate of impact of claims based reporting. We note that before and after the implementation of this program, an ordering professional could employ support staff to transmit an order for an advanced diagnostic imaging service E:\FR\FM\23NOR3.SGM 23NOR3 60042 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations from his or her office to an imaging facility, physician office, or hospital that furnishes advanced diagnostic imaging services. As a result of the flexibility afforded to the means of order communication and transmission, there are many market-based solutions available to adapt this existing workflow to accommodate new information not previously required on orders for advanced diagnostic imaging services. amozie on DSK3GDR082PROD with RULES3 e. Impact on Furnishing Professionals and Facilities We expect that an AUC consultation must take place for every applicable imaging service furnished in an applicable setting and paid for under an applicable payment system. In the CY 2017 PFS final rule (81 FR 80170), we codified the definition of applicable setting in § 414.94(b) to include a physician’s office, a hospital outpatient department (including an emergency department), an ambulatory surgical center, and any other provider-led outpatient setting determined appropriate by the Secretary. In this final rule, we finalize as proposed adding IDTFs to the definition of applicable settings under this program. This was based on the following factors from 2016 CMS Statistics: (1) An IDTF is independent both of an attending or consulting physician’s office and of a hospital; (2) diagnostic procedures when performed by an IDTF are paid under the PFS; (3) independent facilities have increased 5,120 percent from 4,828 in 1990 to 252,044 in 2015; (4) Of those facilities, 1,125 received total payments in excess of $100,000 in 2015; (5) there were 37,038 radiology non-institutional providers utilized by fee-for-service Medicare beneficiaries for all Part B non-institutional provider services in 2015, of which 14,341 received total payments in excess of $100,000 in 2015. Taken together, we believe this will result in a more even application of the Medicare AUC program. To estimate this impact, we assume based on data derived from the CCW’s 2014 Part B non-institutional claim line file, which includes services covered by the Part B benefit that were furnished during CY 2014, that approximately 40,000,000 advanced diagnostic imaging services are furnished annually, but questioned whether for the purposes of this estimate we should attribute equal weight for these services furnished by each of the following places: (1) A physician’s office; (2) a hospital outpatient department; (3) an ambulatory surgical center; and (4) an IDTF. Therefore, we sought to determine the frequency of advanced diagnostic VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 imaging services furnished by each setting. For this estimation, we analyzed 2014 Medicare Part B claims data to weight the various applicable settings subject to this program. For this estimate, we analyzed a count of total services furnished for the following 7 Current Procedural Terminology (CPT) codes for advanced diagnostic imaging studies: 70450—computed tomography, head or brain, without contrast material; 74177—computed tomography, abdomen and pelvis, without contrast material; 70553—magnetic resonance (e.g., proton) imaging, brain (including brain stem), without contrast material, followed by contrast material(s) and further sequences; 72148—magnetic resonance (e.g., proton) imaging, spinal canal and contents, lumbar, without contrast material; 78452—Myocardial perfusion imaging, tomographic singlephoton emission computed tomography (SPECT) including attenuation correction, qualitative or quantitative wall motion, ejection fraction by first pass or gated technique, additional quantification, when performed, multiple studies, at rest and/or stress (exercise or pharmacologic) and/or redistribution and/or rest reinjection; 78492—myocardial imaging, positron emission tomography (PET), perfusion, multiple studies at rest and/or stress; 78803—radiopharmaceutical localization of tumor or distribution of radiopharmaceutical agent(s), tomographic SPECT; which represented 10,000,000 total services or approximately a 25 percent sample of the 40,000,000 total advanced diagnostic imaging services furnished under Part B in 2014. In this sample, we found the following total services and percent of total services for each of the following settings: (1) Physician’s office, 2,997,460 total services, 28.5 percent; (2) hospital outpatient department, 7,465,279 total services, 70.9 percent; (3) ambulatory surgical center, 1,062 total services, 0.01 percent; (4) IDTF, 58,900 total services, 0.6 percent. We also examined whether the total services furnished in 2015 for each setting increased more than 10 percent from 2014. We found the following total services and percent change from 2014 for each of the following settings: (1) Physician’s office, 2,944,144 total services, 2 percent decrease; (2) hospital outpatient department, 7,854,997 total services, 5 percent increase; (3) ambulatory surgical center, 2,900 total services, 173 percent increase; (4) IDTF, 65,479 total services, 11 percent increase. Taken together, we believe these estimates that attribute 70 percent of all advanced diagnostic PO 00000 Frm 00208 Fmt 4701 Sfmt 4700 imaging services to outpatient, 28 percent to physician’s office, and 1 percent each to ambulatory surgical centers and independent diagnostic testing facilities, respectively is generalizable to the total number of visits by Medicare beneficiaries to each of those applicable settings, respectively. We do not expect that for the purposes of this program furnishing professionals and facilities will need to create new billing practices; however, we assume that the majority of furnishing professionals and facilities will work to alter billing practices through automation processes that accommodate AUC consultation information when furnishing advanced diagnostic imaging services to Medicare beneficiaries. Therefore, we believe a transfer of costs and benefits will be made from furnishing professionals and facilities to medical billing companies to create, test, and implement changes in billing practice for all affected furnishing professionals and facilities. As mentioned earlier, the 2016 CMS Statistics identified 37,038 radiology non-institutional providers (Table II.8), and 5,470 ambulatory surgical centers (Table II.5) as of December 31, 2015. Because the classification of independent facilities includes both diagnostic radiology and diagnostic laboratory tests, we will assume that 50 percent of the 252,044 facilities existing in 2015 according to 2016 CMS Statistics (126,022 facilities) furnish advanced diagnostic imaging services. The American Hospital Association (AHA) Hospital Statistics published in 2018 by Health Forum, an affiliate of the AHA, identifies the total number of all U.S. registered hospitals to be 5,534. Taken together, we have identified an estimated 174,064 furnishing professionals (37,038 radiologists + 5,470 ASCs + 126,022 independent diagnostic testing facilities + 5,534 hospitals). We will assume for the purposes of this calculation that every identified furnishing professional and facility will choose to update their processes for the purposes of this program in the same way by purchasing an automated solution to reporting AUC consultation information. The effective date of January 1, 2020 provides some but not extensive time to prepare to update billing processes to accept and report AUC consultation information. Requirements at § 414.94(k) include the following additional information that must be reported: (1) The qualified CDSM consulted by the ordering professional; (2) information indicating whether the service ordered would or would not E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations adhere to specified applicable AUC, or whether the specified applicable AUC consulted was not applicable to the service ordered; (3) the NPI of the ordering professional who consulted specified applicable AUC as required in paragraph (j) of this section, if different from the furnishing professional. Although we are not familiar with any automated billing solution currently available that accommodates this new information, we based our estimate on medical billing and coding for experienced professionals (https:// www.mb-guide.org/), which provides estimates ranging from $1,000 to $50,000 for medical billing software. For example,52 the basic Medisoft software program costs around $1300 while a premium can cost $11,900 for an unlimited amount of users. In another example,7 a simple claims processing interface through McKesson’s Relay Health Clearinghouse costs $200 for preliminary set up, and added monthly service fees that were not described explicitly. Therefore, for the purposes of this calculation such a solution will be estimated to cost each furnishing professional or facility an estimated $10,000. This estimate is based on the assumption that the number of available furnishing professionals and facilities does not equal the number of professionals and facilities furnishing advanced diagnostic imaging services in the Medicare program and although we recognize that more than one furnishing professional or facility may use the same billing service, the combined effectiveness for an automated solution may decrease overall cost. Although we note that this estimate is based on certain assumptions, we estimate that the one-time update will cost $1,740,640,000 (174,064 × $10,000). The Congressional Budget Office estimates that section 218 of the PAMA would save approximately $200,000,000 in benefit dollars over 10 years from FY 2014 through 2024, which could be the result of identification of outlier ordering professionals and also includes section 218(a) of the PAMA—a payment deduction for computed tomography equipment that is not up to a current technology standard. Because we have not yet proposed a mechanism or calculation for outlier ordering professional identification and prior authorization, we are unable to quantify the impact of prior authorization at this time. The following is a summary of the comments we received on the proposed 52 https://www.mb-guide.org/medical-billingsoftware-prices.html. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 estimated impact on furnishing professionals and facilities. Comment: A few commenters noted that the Medicare claim form would change as a result of the Medicare AUC program. These commenters observed that the electronic claim standard for the institutional provider (837i) does not capture or have a placeholder for reporting the ordering physician’s NPI. These commenters stated that hospitals and health systems would need to make sweeping and costly system changes to interface with a modified 837i as a result. Response: We appreciate the opportunity to clarify our sentence and recognize the overlap between reporting AUC consultation information and standardized communications on Medicare claims forms. The X12N insurance subcommittee develops and maintains standards for healthcare administrative transactions on professional (837p), institutional (837i), and dental (837d) transactions when submitting healthcare claims for a service or encounter. The current mandated version of 837 transactions is 5010TM. While we have not finalized a process for implementing the reporting requirements at § 414.94(k), we clarify that implementation of changes to the claim form transactions would not take place outside of the existing process we described. After reviewing all comments, we are finalizing our proposed estimate without modification. However, we note that these estimates are based on multiple assumptions and as such may be an overestimate of burden. f. Appropriate Use Criteria for Advanced Diagnostic Imaging Services We believe that the first 5 years of this program will be dedicated to implementation activities, from installation of the technology to training to operational and behavioral changes. Information on the benefits of adopting qualified CDSMs or automating billing practices specifically meeting the requirements in this final rule does not yet exist—and information on benefits overall is limited. Nonetheless, we believe there are benefits that can be obtained by ordering professionals, furnishing professionals and facilities, beneficiaries and technology infrastructure developers including qualified CDSM developers, EHR systems developers, and medical billing practices. We describe these estimated benefits in more detail in the following sections. PO 00000 Frm 00209 Fmt 4701 Sfmt 4700 60043 (1) Estimates of Savings It has been suggested that one-third of imaging procedures are inappropriate, costing the United States between $3 billion and $10 billion annually 53 (Stein, 2003). Data derived from the CCW 2014 Part B non-institutional claim line file, which includes services covered by the Part B benefit that were furnished during CY 2014, identified approximately $3,300,000,000 in total payments for advanced diagnostic imaging services. For illustrative purposes, if implementation of this program were to lead to a 30 percent decrease in total payments, then we could potentially expect $990,000,000 in fewer payments annually. To address this suggestion, the insertion of a pause in the ordering workflow to introduce AUC is a potentially beneficial and costeffective solution. Some believe that savings could be achieved through the reduction of inappropriate orders, and expenses associated with radiology benefit managers.54 Indeed, the Institute for Clinical Systems Improvement in Bloomington, Minnesota, performed a clinical decision support pilot project 55 to (1) improve the utility of diagnostic radiology tests ordered, (2) reduce radiation exposure, (3) increase efficiency, (4) aid in shared decision making, and (5) save Minnesota $84,000,000 in 3 years. While not directly tested in Miliard et al., we believe this estimate may be generalizable on a national level and applicable to the Medicare AUC program, as both activities seek to achieve improvements in quality and decrease costs. Therefore, if savings estimated in Minnesota were a general representation of the nation, and on average a single state achieved 50percent of that representative savings, annualized over 3 years this estimate could be extrapolated to account for $700,000,000 savings per year (($84,000,000/3 years) × 50-percent × 50 states). It is hypothesized 56 that these benefits are the result of educating ordering professionals on the appropriate test for a set of clinical symptoms, rather than just adding time and electronic obstacles between 53 Stein C. Code red: partners program aims to rein in skyrocketing costs of diagnostic imaging. Boston Globe, 2003. 54 Hardy, K. Decision Support for Rad Reports. Radiology Today. Vol. 11, No. 1, p. 16., 2010. 55 Miliard, M. Nuance, ICSI aim to prevent unnecessary imaging tests. Healthcare IT News. November 10, 2010. 56 Sistrom CL, Dang PA, Weilburg JB, et al., Effect of Computerized Order Entry with Integrated Decision Support on the Growth of Outpatient Procedure Volumes: Seven-year Time Series Analysis. Radiology. 251(1), 2009. E:\FR\FM\23NOR3.SGM 23NOR3 60044 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations amozie on DSK3GDR082PROD with RULES3 ordering physicians and advanced diagnostic imaging services as such transfer of knowledge can alter clinical practice. The Center for Health Care Solutions at Virginia Mason Medical Center in Seattle, Washington examined approaches to control imaging utilization, including external authorization methods and clinical decision support systems. A retrospective cohort study 57 was performed by Blackmore and colleagues in 2011 of the staged implementation of evidence-based clinical decision support for the following advanced diagnostic imaging services: Lumbar MRI; brain MRI; and sinus CT. Brain CT was included as a control. The number of patients imaged as a proportion of patients with selected clinical conditions before and after the decision support interventions were determined from billing data from a regional health plan and from institutional radiology information systems. The imaging utilization rates after the implementation of clinical decision support resulted in decreases for lumbar MRI (p-value = 0.001), head MRI (pvalue = 0.05), and sinus CT (p-value = 0.003), while a decrease in control service head CT was not statistically significant (p-value = 0.88). Although there are limitations to this retrospective claims data analysis, the authors concluded that clinical decision support is associated with large decreases in the inappropriate utilization of advanced diagnostic imaging services. It seems reasonable from this and other studies 58 of local implementation of clinical decision support to assume that there may be some savings when regulations become effective January 1, 2020; however, there are also a few hesitations to extrapolating these and other findings broadly to the Medicare population. First, ordering professionals in this program are aware that CMS will pay for advanced diagnostic imaging services that do not adhere to the specified applicable AUC consulted. This awareness may impact the level of interest or extent of behavior modification from exposing ordering professionals to a qualified CDSM. Second, the statute distinguishes 57 Blackmore, CC; Mecklenburg, RS; Kaplan GS. Effectiveness of Clinical Decision Support in Controlling Inappropriate Imaging. Journal of the American College of Radiology. 8(1) 2011. 58 Curry, L. and Reed, M.H. Electronic decision support for diagnostic imaging in a primary care setting. J Am Med Inform Assoc. 2011; 18: 267–270; Ip, I.K., Schneider, L.I., Hanson, R. et al. Adoption and meaningful use of computerized physician order entry with an integrated clinical decision support system for radiology: ten-year analysis in an urban teaching hospital. J Am Coll Radiol. 2012; 9: 129–136. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 between the ordering professional, furnishing professional and facility, recognizing that the professional who orders an applicable imaging service is usually not the same professional or facility reporting to Medicare for that service when furnished. As a result, some ordering professionals may believe that since they are not required to submit AUC consultation information directly to CMS, there are no direct consequences of adhering to specified applicable AUC. Third, many advanced diagnostic imaging services may not have relevant or applicable AUC. Indeed a recent study 59 implementing CDS was only able to prospectively generate a score for 26 percent and 30 percent of requests for advanced diagnostic imaging services before and after implementation of decision support, respectively. Without AUC available, there can be no decision support intervention into the workflow of the ordering professional. Fourth, even when an ordering professional identifies an advanced diagnostic imaging service recognized as adhering to specified applicable AUC from one qualified PLE, discordance between AUC from different specialty societies has been reported,60 suggesting that full benefits and savings cannot be realized without standard levels of appropriateness. Taken together, these concerns will form the basis for our continued examination of the impact of this and future rulemaking to maximize the benefits of this program. (2) Benefits to Medicare Beneficiaries Although qualified CDSMs are not required to demonstrate that their tools provide measurable benefits, we believe that as a result of installation and use, some ordering professionals may find benefits to the patients they serve. For example, if a qualified CDSM creates a flag or alert to obsolete tests, then the patient will benefit from avoiding unnecessary testing. The same outcome would be likely if a qualified CDSM implemented algorithms that recognize advanced diagnostic imaging services that may produce inaccurate results because of medications being taken by the patient. In addition, if the CDSM provides standardized processes for advanced diagnostic imaging orders or clarification for confusing test names, 59 Moriarity, AK, Klochko C, O’Brien M, Halabi S. The Effect of Clinical Decision Support for Advanced Inpatient Imaging. Journal of American College of Radiology. 12(4) 2015. 60 Winchester DE et al., Discordance Between Appropriate Use Criteria for Nuclear Myocardial Perfusion Imaging from Different Specialty Societies: a potential concern for health policy. JAMA Cardiol. 1(2) 2016:207–210. PO 00000 Frm 00210 Fmt 4701 Sfmt 4700 then the patient benefits from a potential decrease in medical errors and less exposure. Finally, we believe it is reasonable to assume that some improvements in shared decision making could result from use of a qualified CDSM, because some CDSMs could provide cost information associated with advanced diagnostic imaging services and/or identify situations of repeated testing. The following is a summary of the comments we received on the proposed estimated benefits that can be obtained by ordering professionals, furnishing professionals and facilities, beneficiaries and technology infrastructure developers including qualified CDSM developers, EHR systems developers, and medical billing practices. Comment: A few commenters disagreed that there are any benefits to the Medicare AUC program. As an example, one commenter submitted their experience with a CDSM and found that a change in utilization was not significant. Additionally, a few commenters indicated that every dollar spent on this program is a dollar that cannot be used elsewhere, more specifically, for patient care. One commenter disagreed with these comments, citing a published study 61 that exposing ordering professionals to evidence based medicine improves quality and reduces inappropriate utilization. Another commenter cited several evidence-based studies 15 62 63 that demonstrate the improvement in the quality of clinical outcomes and reduction of cost resulting from engagement using AUC. Response: We thank the commenters for sharing their experience, and experiences cited in peer-reviewed published literature. This RIA is presented in conjunction with statutory AUC program requirements. We provide these estimates in addition to policies that are consistent with statute and finalized in this rule. However, we note that these estimates are based on multiple assumptions and as such may be an overestimate of burden as a free qualified CDSM is available and required by law. 61 Huber TC, Krishmaraj A, Patrie J, et al. Impact of a commercially available clinical decision support program on provider ordering habits. J Am Coll Radiol. 2018:15:951–7. 62 Bunt CW, Burke HB, Towbin AJ, et al. Pointof-care estimated radiation exposure and imaging guidelines can reduce pediatric radiation burden. J Am Board Fam Med. 2015:28:343–50. 63 Tajmir S, Raja AS, Ip IK, et al. Impact of clinical decision support on radiography for acute ankle injuries: a randomized trial. West J Emerg Med. 2017:18(3):487–95. E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 5. Medicaid Promoting Interoperability Program Requirements for Eligible Professionals (EPs) Medicaid Promoting Interoperability Program Requirements for Eligible Professionals (EPs) In the Medicaid Promoting Interoperability Program, to keep electronic clinical quality measure (eCQM) specifications current and minimize complexity, we proposed to align the eCQMs available for Medicaid EPs in 2019 with those available for MIPS eligible clinicians for the CY 2019 performance period. We explained that we anticipated that this proposal would reduce burden for Medicaid EPs by aligning the requirements for multiple reporting programs, and that the system changes required for EPs to implement this change would not be significant, as many EPs are expected to report eCQMs to meet the quality performance category of MIPS and therefore should be prepared to report on those eCQMs for 2019. We explained that we expected that this proposal would have only a minimal impact on states, by requiring minor adjustments to state systems for 2019 to maintain current eCQM lists and specifications. State expenditures to make any systems changes required as a result of this proposal would be eligible for ninety percent enhanced Federal financial participation. After careful consideration of the comments received on this proposal, we are finalizing it without change. See discussion of comments in section III.E. of this final rule. For 2019, we proposed that Medicaid EPs would report on any six eCQMs that are relevant to the EP’s scope of practice, including at least one outcome measure, or if no applicable outcome measure is available or relevant, at least one high priority measure, regardless of whether they report via attestation or electronically. This policy would generally align with the MIPS data submission requirement for eligible clinicians using the eCQM collection type for the quality performance category, which is established in § 414.1335(a)(1). After careful consideration of the comments received on this proposal, we are finalizing it without change, and also explain that if no outcome or high priority measure is relevant to a Medicaid EP’s scope of practice, he or she may report on any six eCQMs that are relevant. We also proposed that the eCQM reporting period for EPs in the Medicaid Promoting Interoperability Program would be a full CY in 2019 for EPs who have demonstrated meaningful use in a prior year, in order to align with the VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 corresponding performance period for the quality performance category in MIPS. This proposal is also finalized without change, after careful consideration of comments received. (See discussion of comments in section III.E. of this final rule.) We continue to align Medicaid Promoting Interoperability Program requirements with requirements for other CMS quality programs, such as MIPS, to the extent practicable, to reduce the burden of reporting different data for separate programs. In order to help states to make incentive payments to Medicaid EPs by December 31, 2021, consistent with section 1903(t)(4)(A)(iii) of the Act, we proposed to amend § 495.4 to provide that the EHR reporting period in 2021 for all EPs in the Medicaid Promoting Interoperability Program would be a minimum of any continuous 90-day period within CY 2021, provided that the end date for this period falls before October 31, 2021, to help ensure that the state can issue all Medicaid Promoting Interoperability Program payments on or before December 31, 2021. Similarly, we proposed to change the eCQM reporting period in 2021 for EPs in the Medicaid Promoting Interoperability Program to a minimum of any continuous 90-day period within CY 2021, provided that the end date for this period falls before October 31, 2021, to help ensure that the state can issue all Medicaid Promoting Interoperability Program payments on or before December 31, 2021. We proposed to allow states the flexibility to set alternative, earlier final deadlines for EHR or eCQM reporting periods for Medicaid EPs in CY 2021, with prior approval from CMS, through their State Medicaid HIT Plans (SMHP). Providing states with the flexibility to set an alternative, earlier last possible date for the EHR or eCQM reporting period for Medicaid EPs in 2021 would make it easier for states to ensure that all payments are made by the December 31, 2021 deadline, especially for states whose prepayment process may take longer than the 61 days provided for by an October 31, 2021 deadline. We explained that we expect that this proposal would have only a minimal impact on states, by requiring minor adjustments to state systems to meet specifications for the proposed reporting periods, especially because we are also proposed to permit states to set a different end date for all EHR and eCQM reporting periods for Medicaid EPs in 2021. As previously noted, state expenditures for any systems changes required as a result of this proposal would be eligible for 90 percent enhanced Federal financial PO 00000 Frm 00211 Fmt 4701 Sfmt 4700 60045 participation. After careful consideration of the comments received on this proposal, as discussed above in section III.E. of this final rule, we are finalizing it without change. However, in light of comments received from EPs, we are also considering whether to propose in future rulemaking that no state may set a reporting period deadline for CY 2021 that is earlier than June 30, 2021, or an attestation deadline for CY 2021 that is earlier than July 1, 2021. Finally, we proposed changes to the EP Meaningful Use Objective 6, (Coordination of care through patient engagement) Measure 1 (View, Download, or Transmit) and Measure 2 (Secure Electronic Messaging), and to EP Meaningful Use Objective 8, Measure 2 (Syndromic surveillance reporting). We proposed to amend these measures in response to feedback about the burdens they create for EPs seeking to demonstrate meaningful use, and about how they may not be fully aligned with how states and public health agencies collect syndromic surveillance data. These proposed amendments were expected to reduce EP burden. Again, we expected that any changes these proposals might require to state systems would be minimal and that state expenditures to make any such changes would also be eligible for 90 percent enhanced federal financial participation. After careful consideration of the comments received on these proposals, as discussed in section III.E. of this final rule, we are finalizing them without change. 6. Medicare Shared Savings Program In section III.F.1.b. of this final rule, we summarize the proposed certain modifications to the quality measure set used to assess the quality of performance of ACOs participating in the Shared Savings Program. Specifically we proposed: (1) The addition of two Patient Experience of Care Survey measures, and (2) the removal of four claims-based outcome measures. After consideration of the comments received, we are finalizing these proposed modifications to the quality measure set for the Shared Savings Program in sections III.F. of this final rule. The modifications to the Shared Savings Program quality measure set reduce the number of measures in the Shared Savings Program quality measure set from 31 to 23 measures, making the quality measure set more outcome oriented. This reduction in the number of measure is expected to reduce ACO reporting burden and E:\FR\FM\23NOR3.SGM 23NOR3 60046 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations improve quality outcomes for beneficiaries. amozie on DSK3GDR082PROD with RULES3 7. Physician Self-Referral Law The physician self-referral law provisions are discussed in section III.G. of this final rule. We are finalizing regulatory updates to implement the provisions of section 50404 of the Bipartisan Budget Act of 2018 pertaining to the writing and signature requirements in certain compensation arrangement exceptions to the statute’s referral and billing prohibitions. The regulatory language for the writing requirement reflects current policy, so we do not anticipate that it will have an impact. We expect that the update regarding temporary non-compliance with signature arrangements will reduce burden by giving parties additional time to obtain all required signatures. 8. Changes Due to Updates to the Quality Payment Program In section III.I. of this final rule, we included our finalized policies for the Quality Payment Program. In this section of the final rule, we present the overall and incremental impacts to the number of expected QPs and associated APM incentive payments. In MIPS, we analyze the total impact and incremental impact of statutory changes to eligibility from the Bipartisan Budget Act of 2018, as well as final policies to expand MIPS eligibility by expanding the MIPS eligible clinician definition and adding a third criterion for the lowvolume threshold and an opt-in policy option for any clinician that exceeds at least one, but not all, of the low-volume threshold criteria. Finally, we estimate the payment impacts by practice size based on various final policies to modify the MIPS final score, such as the new Promoting Interoperability performance category policies, for the performance threshold and additional performance threshold, and as required by the Bipartisan Budget Act of 2018, the impact of applying the MIPS payment adjustments to covered professional services (services for which payment is made under, or is based on, the PFS and that are furnished by an eligible clinician) rather than items and services covered under Part B. The submission period for the first MIPS performance period ended in early 2018; however, the final data sets were not available in time to incorporate into the CY 2019 PFS proposed rule analysis (83 FR 36057). We stated in the proposed rule that if technically feasible, we intended to use data from the CY 2017 MIPS performance period for the final rule. In this analysis, we have updated our analyses from the VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 proposed rule to consider data submitted for the 2017 MIPS performance period (which we refer to in this section as Quality Payment Program Year 1 data). In section VII.F.8.b. of this final rule, we summarize the high level findings of updating our model with Quality Payment Program Year 1 data. a. Estimated Incentive Payments to QPs in Advanced APMs and Other Payer Advanced APMs From 2019 through 2024, through the Medicare Option, eligible clinicians receiving a sufficient portion of Medicare Part B payments for covered professional services or seeing a sufficient number of Medicare patients through Advanced APMs as required to become QPs, for the applicable performance period, will receive a lump-sum APM Incentive Payment equal to 5 percent of their estimated aggregate payment amounts for Medicare covered professional services in the preceding year. In addition, beginning in payment year 2021, in addition to the Medicare Option, eligible clinicians may become QPs through the All-Payer Combination Option. The All-Payer Combination Option will allow eligible clinicians to become QPs by meeting the QP thresholds through a pair of calculations that assess a combination of both Medicare Part B covered professional services furnished through Advanced APMs and services furnished through Other Payer Advanced APMs. The APM Incentive Payment is separate from and in addition to the payment for covered professional services furnished by an eligible clinician during that year. Eligible clinicians who become QPs for a year would not need to report to MIPS and would not receive a MIPS payment adjustment to their Part B PFS payments. Eligible clinicians who do not become QPs, but meet a slightly lower threshold to become Partial QPs for the year, may elect to report to MIPS and, if they elect to report, would then be scored under MIPS and receive a MIPS payment adjustment, but will not receive the APM Incentive Payment. For the 2019 Medicare QP Performance Period, we define Partial QPs to be eligible clinicians in Advanced APMs who collectively have at least 40 percent, but less than 50 percent, of their payments for Part B covered professional services through an APM Entity, or collectively furnish Part B covered professional services to at least 20 percent, but less than 35 percent, of their Medicare beneficiaries through an APM Entity. If the Partial QP elects to PO 00000 Frm 00212 Fmt 4701 Sfmt 4700 be scored under MIPS, they would be subject to all MIPS requirements and would receive a MIPS payment adjustment. This adjustment may be positive, negative or neutral. If an eligible clinician does not meet either the QP or Partial QP standards, and does not meet any another exemption category, the eligible clinician would be subject to MIPS, would report to MIPS, and would receive the corresponding MIPS payment adjustment. Beginning in payment year 2026, payment rates for services furnished by clinicians who achieve QP status for a year would be increased each year by 0.75 percent for the year, while payment rates for services furnished by clinicians who do not achieve QP status for the year would be increased by 0.25 percent. In addition, MIPS eligible clinicians would receive positive, neutral, or negative MIPS payment adjustments to payment for their Part B PFS services in a payment year based on performance during a prior performance period. Although MACRA amendments established overall payment rate and procedure parameters until 2026 and beyond, this impact analysis covers only the third payment year (2021 MIPS payment year) of the Quality Payment Program in detail. In section III.I.4.g.(4)(b) of this final rule, we summarized our finalized policy to add a third alternative to allow requests for QP determinations at the TIN level in instances where all clinicians who have reassigned billing rights under the TIN participate in a single APM Entity. This option will therefore be available to all TINs participating in Full TIN APMs, such as the Medicare Shared Savings Program. It will also be available to any other TIN for whom all clinicians who have reassigned billing rights to the TIN are participating in a single APM Entity. We also finalized that this third alternative will only be available to eligible clinicians who meet the Medicare threshold at the APM Entity level; it will not be available for eligible clinicians who meet the Medicare threshold individually. In section III.I.4.g.(4)(c)(ii) of this final rule, we also discussed our finalized policy to extend the same weighting methodology to TIN level Medicare Threshold Scores in situations where a TIN is assessed under the Medicare Option as part of an APM Entity group, and receives a Medicare Threshold Score at the APM Entity group level. In this scenario, we believe that the Medicare portion of the TIN’s All-Payer Combination Option Threshold Score should not be lower than the Medicare Threshold Score that they received by E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations participating in an APM Entity group (82 FR 53881 through 53882). We note this extension of the weighting methodology will only apply to a TIN when that TIN represents a subset of the eligible clinicians in the APM Entity, because when the TIN and the APM Entity are the same there is no need for this weighted methodology. We finalized our proposal to calculate the TIN’s QP Threshold Scores both on its own and with this weighted methodology, and then use the most advantageous score when making a QP determination. We believe that, as it does for QP determinations made at the APM Entity level, this approach promotes consistency between the Medicare Option and the All-Payer Combination Option to the extent possible. Additionally, the application of this weighting approach in the case of a TIN level QP determination is consistent with our established policy. These finalized policies affect the estimated number of QPs for the 2021 payment year. We estimate that approximately 8,100 eligible clinicians in 8 APM Entities representing approximately 225 TINs will become QPs due to these finalized policies representing TIN level QP determinations under the All-Payer Combination Option. Therefore, they will be excluded from MIPS, and qualify for the lump sum incentive payment based on 5 percent of their Part B allowable charges for covered professional services, which are estimated to be approximately $545 million in the 2019 performance year. We also estimated the corresponding increase of the APM incentive payment of 5 percent of Part B allowed charges for these QPs will be approximately $27 million for the 2021 payment year. However, we note that the majority, if not all, of the 8,100 eligible clinicians that would become QPs if these policies are finalized, had already attained QP status in the 2018 QP performance period. Therefore, the associated APM incentive payments for these 8,100 would not be additional impacts in comparison to previous performance years, only additional impacts in the absence of finalizing these proposed policies. Overall, we estimated that between 165,000 and 220,000 eligible clinicians will become QPs, therefore be excluded from MIPS, and qualify for the lump sum incentive payment based on 5 percent of their Part B allowable charges for covered professional services in the preceding year, which are estimated to be between approximately $12,000 million and $16,000 million in total for the 2019 performance year. We VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 estimated that the aggregate total of the APM incentive payment of 5 percent of Part B allowed charges for QPs will be between approximately $600 and $800 million for the 2021 payment year. The estimated number of QPs in this final rule is slightly higher than the estimates of 160,000 and 215,000 clinicians included in the proposed rule due to more updated information being available for the final rule. The proposed rule used the APM Participation Lists on the most recent MDM provider extract for the Predictive QP determination file for 2018, whereas this final rule uses the APM Participation Lists on the most recent MDM provider extract for the Second QP determination file for the 2018 performance period. This more updated information did not significantly change the estimated amount of total Part B allowed charges and the amount of total APM incentive payments. We projected the number of eligible clinicians that will be QPs, and thus excluded from MIPS, using several sources of information. First, the projections are anchored in the most recently available public information on Advanced APMs. The projections reflect Advanced APMs that will be operating during the 2019 QP performance period, as well as Advanced APMs anticipated to be operational during the 2019 QP performance period. The projections also reflect an estimated number of eligible clinicians that would attain QP status through the All-Payer Combination Option. The following APMs are expected to be Advanced APMs in performance year 2019: Next Generation ACO Model, Comprehensive Primary Care Plus (CPC+) Model, Comprehensive ESRD Care (CEC) Model (Two-Sided Risk Arrangement), Vermont All-Payer ACO Model (Vermont Medicare ACO Initiative),64 Comprehensive Care for Joint Replacement Payment Model (CEHRT Track), Oncology Care Model (TwoSided Risk Arrangements), Medicare ACO Track 1+ Model, Bundled Payments for Care Improvement Advanced, Maryland Total Cost of Care Model (Maryland Care Redesign Program; Maryland Primary Care Program), and the Shared Savings Program Tracks 2 and 3. We used the APM Participant Lists (see 81 FR 77444 through 77445 for information on the APM participant lists and QP determination) on the most recent MDM 64 Vermont ACOs are participating in an Advanced APM during 2018 through a version of the Next Generation ACO Model. The Vermont Medicare ACO Initiative is expected to be an Advanced APM beginning in CY 2019. PO 00000 Frm 00213 Fmt 4701 Sfmt 4700 60047 provider extract for the Second QP determination file for 2018 QP performance period to estimate QPs, total Part B allowed charges for covered professional services, and the aggregate total of APM incentive payments for the 2019 QP performance period. We examine the extent to which Advanced APM participants would meet the QP thresholds of having at least 50 percent of their Part B covered professional services or at least 35 percent of their Medicare beneficiaries furnished Part B covered professional services through the APM Entity. b. Updates to MIPS Estimates Using Quality Payment Program Year 1 Data In the CY 2019 PFS proposed rule (83 FR 36058 through 36068), the RIA modeled MIPS eligibility and performance using data from the Physician Quality Reporting System (PQRS), the Value Modifier, and the Medicare/Medicaid EHR Incentive programs to account for the absence of MIPS performance data. We indicated, that if feasible, we would integrate performance data from the CY 2017 MIPS performance period (which we refer to in this section of the final rule as Quality Payment Program Year 1 data). The model in the 2019 PFS proposed rule had several assumptions to proxy MIPS performance and we noted the limitations of the model (83 FR 36067). In this final rule, we integrated Quality Payment Program Year 1 data into our model estimates and we chose to summarize in this section important differences or findings that are needed for context when interpreting the RIA in this final rule. It should be noted that although we are using Quality Payment Program Year 1 data, the estimates described in this RIA reflect the impact of the finalized policies in this final rule and do not reflect actual CY 2017 MIPS performance period/2019 MIPS payment year results. First, the Quality Payment Program Year 1 data had more complete group and individual participation and performance data. In the CY 2019 PFS proposed rule (83 FR 36053 through 36061), we estimated group reporting solely based on the submission of quality data as a group to 2016 PQRS. For this final rule, we were able to identify group reporting through submissions to quality, improvement activities or Promoting Interoperability performance categories. As a result, we observed higher group reporting than was previously estimated using PQRS performance data. This finding led to a 42 percent increase (from approximately 390,000 in the CY 2019 PFS proposed E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 60048 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations rule to 553,000 in this final rule) in group reporters who otherwise would not have been MIPS eligible clinicians. (See section VII.F.8.c. for more details on eligibility.) The second benefit of group and individual level data through the Quality Payment Program Year 1 data led to our improved ability to better estimate group and individual scores and to appropriately apply scoring policies at the group and individual level. (See section VII.F.8.d.(2) for more details on methodologies for estimating the performance category scores.) Second, we observed an increase in participation among small practices than previously estimated in the CY 2019 PFS proposed rule. The number of clinicians in small practices (who we believe are estimated to be in MIPS year 3) estimated to submit data increased from 79.7 percent to 89.9 percent. We believe this is related to our policies for the 2017 MIPS performance period which was designed to encourage participation, engage clinicians and help them transition smoothly into MIPS. (See section VII.F.8.d.(3) for more details.) Third, the Quality Payment Program Year 1 data allowed for the direct observation of performance for the MIPS performance categories. With the availability of actual advancing care information and improvement activities performance category data from the Quality Payment Program Year 1, we improved our estimates for the Promoting Interoperability and improvement activities performance category scores at the individual and group level for the 2019 MIPS performance period/2021 MIPS payment year. This led to more variation in performance at the individual and group level for these performance categories compared to the model in the 2019 PFS proposed rule and to the ability to accurately assess which clinicians are measured on Promoting Interoperability or are reweighted (see section III.I.3.h.(5) of this final rule for more details). Finally, the Quality Payment Program Year 1 data improved our ability to estimate who is excluded from MIPS, such as newly enrolled clinicians. We found that the previous proxy for the CY 2019 PFS proposed rule overestimated the number of newly enrolled clinicians than the observed with the Quality Payment Program Year 1 data. As a result, fewer clinicians were excluded from MIPS compared to the CY 2019 PFS proposed rule. (See section VII.F.8.c.(2) of this final rule for more details.) In summary, the estimates presented in the RIA of this final rule differ from VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 the CY 2019 PFS proposed rule due to our ability to improve our estimates of eligibility and performance in MIPS. As a result of data source and methodology changes for the final policies of this final rule, we observe a slight decrease in final scores. For example, the mean and median final scores in the CY 2019 PFS proposed rule analysis were 73.41 and 82.41 respectively,65 and the mean and median in this final rule are 69.53 and 78.72, respectively. As a result, a higher percentage of clinicians submitting data have scores below the final performance threshold of 30 points for this final rule (8.8 percent) compared to the CY 2019 PFS proposed rule (3.9 percent). Given the increase in participation, we are not surprised by these changes. However, it should be noted we are still using historic data to predict future performance. Therefore, behaviors due to policies in MIPS Year 1 may not reflect behaviors in Year 3. For example, MIPS eligible clinicians had to earn 3 out of 100 points to receive at least a neutral payment adjustment in CY 2017 MIPS performance period/CY 2021 MIPS payment year and therefore may have only submitted a limited amount of information. As the performance threshold increases in Year 3, we anticipate clinicians will continue to participate and will likely increase their performance to meet the higher performance threshold. Therefore, the results presented in this final rule may not accurately reflect performance for CY 2019 performance period/CY 2021 payment year, which is an important limitation of our findings. See section VII.F.8.f. for more limitations of this rule. c. Estimated Number of Clinicians Eligible for MIPS Eligibility (1) Summary of Final Policies Related to MIPS Eligibility and Application of MIPS Payment Adjustments In section III.I.3 of this final rule, we finalized three sets of policy changes that would impact the number of MIPS eligible clinicians starting with CY 2019 MIPS performance period and the associated CY 2021 MIPS payment year. Two of the changes were finalized as proposed and affect the low-volume threshold. The third policy affects the definition of a MIPS eligible clinician and was finalized with modifications. In section III.I.3.c.(2) of this final rule, we finalized as proposed changes to our policy to comply with the Bipartisan 65 The mean and median was not published in the CY 2019 PFS proposed rule RIA, but the methodology is summarized in the CY 2019 PFS proposed rule (83 FR 36058 through 36066). PO 00000 Frm 00214 Fmt 4701 Sfmt 4700 Budget Act of 2018. Specifically, we updated the low-volume threshold starting with the 2020 MIPS payment year to be based on covered professional services (services for which payment is made under, or is based on the PFS and that are furnished by an eligible clinician) rather than items and services covered under Part B, as provided in section 1848(q)(1)(B) as amended by section 51003(a)(1)(A)(i) of the Bipartisan Budget Act of 2018. This finalized policy may affect the previously finalized calculation for the low-volume threshold for certain clinicians because payment for items, such as Part B drugs, which were previously considered in the lowvolume determination, are now excluded. In addition, section 51003(a)(1)(E) of the Bipartisan Budget Act of 2018 revised section 1848(q)(6)(E) to apply the MIPS payment adjustments to covered professional services rather than to items and services covered under Part B. This change is effective with the 2019 MIPS payment year. Its effect on the amount of payment adjustments under MIPS is included in this analysis. Second, in section III.I.3.a. of this final rule, beginning with the 2021 MIPS payment year, we finalized with modification the expansion of the definition of MIPS eligible clinicians to include physical therapists, occupational therapists, speechlanguage pathologists, audiologists, clinical psychologists, and registered dietitians or nutrition professionals. This finalized list differs from the proposed list of physical therapists, occupational therapists, clinical social workers, and clinical psychologists (83 FR 36058). Specifically, we finalized the definition of MIPS eligible clinician, as identified by a unique billing TIN and NPI combination used to assess performance, as any of the following: A physician (as defined in section 1861(r) of the Act); a physician assistant, nurse practitioner, and clinical nurse specialist (as such terms are defined in section 1861(aa)(5) of the Act); a certified registered nurse anesthetist (as defined in section 1861(bb)(2) of the Act), physical therapist, occupational therapist, speech-language pathologist, audiologist, clinical psychologist, and registered dietitian or nutrition professional; and a group that includes such clinicians. Third, as discussed in sections III.I.3.c.(4) and III.I.3.c.(5) of this final rule, in addition to the amendments to comply with Bipartisan Budget Act of 2018, we finalized as proposed our definition of the low-volume threshold by adding a third criterion (for ‘‘covered E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations professional services’’). The low-volume threshold now includes a third criterion: Set at 200 covered professional services to Part B-enrolled individuals. Taken together, the lowvolume threshold is as follows: (1) Those with $90,000 or less in allowed charges for covered professional services; or (2) 200 or fewer Part B-enrolled individuals who are furnished Medicare PFS services; or (3) 200 or fewer covered professional services. The low volume threshold assessment is applied at the TIN/NPI level for individual reporting, the TIN level for group reporting, or the APM Entity Level for reporting under the APM scoring standard. We also finalized as proposed for any clinician who exceeds the low-volume threshold on at least one, but not all three, lowvolume threshold criteria may elect to opt-in to MIPS to be measured on performance, thereby qualifying to receive a positive, neutral, or negative MIPS payment adjustment based on performance. The absence of the opt-in election within this cohort means they are not MIPS eligible clinicians. If a MIPS eligible clinician does not meet at least one of these low-volume criteria, they are excluded from MIPS. For purposes of this impact analysis we refer to these revisions to the lowvolume threshold and its application collectively as the ‘‘opt-in policy’’. We discuss how the three finalized policy changes impact MIPS eligibility and payments, later in this section. amozie on DSK3GDR082PROD with RULES3 (2) Methodology To Assess MIPS Eligibility (a) Clinicians Included in the Model Prior to Applying the Low-Volume Threshold Exclusion To estimate the number of MIPS eligible clinicians for the CY 2019 performance period in this final rule, our scoring model used the first determination period from CY 2020 MIPS payment year eligibility file as described in the CY 2018 Quality Payment Program Final Rule (82 FR 53587 through 53592). The first determination period from the CY 2020 MIPS payment year eligibility file was selected to maximize the overlap with the performance period data used in the model. In addition, the low-volume threshold for with the 2020 MIPS payment year was originally finalized in the CY 2018 Quality Payment Program final rule (82 FR 53587 through 53592) as using Part B items and services, but was later finalized in section III.I.3.c of this final rule to be based on covered professional services (services for which payment is made under, or is based on VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 the PFS and that are furnished by an eligible clinician). Therefore, this data file provided the information to calculate a baseline as well as understand the incremental impact of basing the low-volume threshold on covered professional services rather than all items and services under Part B. We included 1.5 million clinicians (see Table 97) who had PFS claims from September 1, 2016 to August 31, 2017 and included a 30-day claim run-out.We excluded individual clinicians who were affected by the automatic extreme and uncontrollable policy finalized for the 2017 MIPS performance period/2019 MIPS payment year in section III.I.3.i.(2)(b)(ii)(B) of this final rule as we are unable to predict how these clinicians would perform in a year where there was no extreme and uncontrollable event. Clinicians are ineligible for MIPS (and are excluded from MIPS payment adjustment) if they are newly enrolled to Medicare; are QPs; are partial QPs who elect to not participate in MIPS; are not one of the clinician types included in the definition for MIPS eligible clinician; or do not exceed the lowvolume threshold. Therefore, we excluded these clinicians when calculating those clinicians eligible for MIPS. For our baseline population, we restricted to clinicians who are a physician (as defined in section 1861(r) of the Act); a physician assistant, nurse practitioner, and clinical nurse specialist (as such terms are defined in section 1861(aa)(5) of the Act); a certified registered nurse anesthetist (as defined in section 1861(bb)(2) of the Act). For the estimated MIPS eligible population for the CY 2021 MIPS payment year, we added in clinicians who are physical therapists, occupational therapists, speechlanguage pathologist, audiologist, clinical psychologist, and registered dietitian or nutrition professional. As noted previously, we excluded QPs from our scoring model, since these clinicians are not eligible for MIPS. To determine which QPs should be excluded, we used the QP List for the first snapshot date of the 2018 QP performance period because these data were available by TIN and NPI and could be merged into our model. This data also included participants in APMs, such as the Medicare ACO Track 1+ Model, which were not available models in the 2017 QP performance period. From this data, we calculated the QP determinations as described in the Qualifying APM Participant definition at § 414.1305 for the 2019 QP performance period. We assumed that PO 00000 Frm 00215 Fmt 4701 Sfmt 4700 60049 all partial QPs would participate in MIPS and included them in our scoring model and eligibility counts. The estimated number of QPs excluded from our model is lower than the projected number of QPs (165,000 to 220,000) for the 2019 QP performance period due to the expected growth in APM participation. Due to data limitations, we could not identify specific clinicians who may become QPs in the 2019 Medicare QP Performance Period; hence, our model may overestimate the fraction of clinicians and allowed charges for covered professional services that will remain subject to MIPS after the exclusions. We also excluded newly enrolled Medicare clinicians from our model. To identify newly enrolled Medicare clinicians, we used the indicator that was used for the 2017 MIPS performance period/2019 MIPS payment year. The number of newly enrolled clinicians identified using this approach and data source was approximately one third the estimated number of newly enrolled clinicians estimated in the proposed rule which indicates we overestimated the number of newly enrolled clinicians in the CY 2019 PFS proposed rule impact analysis and that more clinicians are eligible for MIPS. In section III.I.3.j.(4)(c) of this final rule, we finalized that beginning with the 2019 MIPS payment year the MIPS payment adjustment factors would not apply to certain model-specific payments for the duration of a section 1115A model’s testing. Due to the aggregated data in our analysis, we were not able to incorporate this policy into our estimate. In section III.I.3.j.(4)(d) of the final rule, we finalized the proposal to waive the payment consequences (positive, negative or neutral adjustments) of MIPS and to waive the associated MIPS reporting requirements adopted to implement the payment consequences for certain participating clinicians in the MAQI Demonstration subject to conditions outlined in the Demonstration, starting with the 2020 MIPS payment period. Removing eligible clinicians from MIPS may affect the payment adjustments for other MIPS eligible clinicians in each year the waiver is offered. At this time we are unable to identify specific clinicians that would be affected by this proposal (that is, removed from the MIPS payment adjustments), but estimate the first year number of clinicians to be less than 0.1 percent of all MIPS eligible clinicians. We plan to monitor the impact of the MAQI Demonstration on payments received by MIPS eligible E:\FR\FM\23NOR3.SGM 23NOR3 60050 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations clinicians to whom the waivers do not apply; however, we note that it may be challenging to draw significant conclusions from such monitoring as there are many variables that may impact and influence a clinician’s final MIPS adjustment. Due to the lack of information currently available we are unable to account for this proposal in the eligibility or payment adjustment tables. (b) Assumptions Related to Applying the Low-Volume Threshold Exclusion amozie on DSK3GDR082PROD with RULES3 The low-volume threshold policy may be applied at the individual (that is, TIN/NPI) or group (that is, TIN or APM entity) levels based on how data are submitted. If no data are submitted, then the low-volume threshold is applied at the TIN/NPI level. A clinician or group that exceeds at least one but not all three low-volume threshold criteria may become MIPS eligible by electing to optin and subsequently submitting data to MIPS, thereby getting measured on performance and receiving a MIPS payment adjustment. Table 97 compares the MIPS eligibility status and the associated PFS allowed charges from the CY 2019 PFS proposed rule (83 FR 36060) with the estimates of MIPS eligibility and the associated PFS allowed charges after using Quality Payment Program Year 1 data and applying the finalized policies for the CY 2019 MIPS performance period. For the purposes of modeling, we made assumptions on group reporting to apply the low-volume threshold. One extreme and unlikely assumption is that no practices elect group reporting and the low-volume threshold would always be applied at the individual level. Although we believe a scenario in which only these clinicians would participate as individuals is unlikely, this assumption is important because it quantifies the minimum number of MIPS eligible clinicians. For final rule model, we estimate there are approximately 217,000 clinicians 66 who would be MIPS eligible because they exceed the low volume threshold as individuals and are not otherwise 66 The count of 216,612 MIPS eligible clinicians for required eligibility includes those who participated in MIPS (196,236 MIPS eligible clinicians) as well as those who did not participate (17,376 MIPS eligible clinicians). VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 excluded. In Table 97,67 we identify clinicians under this assumption as having ‘‘required eligibility.’’ Using this assumption, the number of clinicians with required eligibility in this final rule and their associated PFS allowed charges are very similar to the estimate in the CY 2019 PFS proposed rule (approximately 218,000 clinicians). Based on CY 2017 Quality Payment Program Year 1 data, we anticipate that group and APM Entities that submitted to MIPS as a group and APM Entity will continue to do so for the CY 2019 MIPS performance period. Therefore, if we revise our model’s group reporting assumption such that all clinicians that were participating in ACOs in 2017 (including ACOs participating under the Shared Savings Program or Next Generation ACO Model) or who reported to the Quality Payment Program Year 1 as a group would continue to do so in MIPS, then the MIPS eligible clinician population would be approximately 770,000 clinicians if we only include the 218,000 required clinicians and the 553,000 clinicians who are only eligible because of group reporting. In Table 97, we identify these clinicians who do not meet the low-volume threshold individually but are anticipated to submit to MIPS as a group based on Quality Payment Program Year 1 data as having ‘‘group eligibility.’’ Updating the data source for identifying group reporting led to a 42 percent increase (from approximately 390,000 in the proposed rule to 553,000 in this final rule) in clinicians in the ‘‘group eligibility’’ category. We also observed a 33 percent increase in the PFS allowed charges in MIPS from $10,262 million in the proposed rule to $13,662 million in this final rule for the clinicians in the ‘‘group eligibility’’ category. The previous estimate presented in the proposed rule likely underestimated the number of clinicians using group reporting since previously group reporting could only be identified through the submission of quality data to PQRS. With the availability of CY 2017 Quality Payment Program Year 1 data, we can identify group reporting through the submission of improvement activities, Promoting Interoperability, or quality performance category data.To model the proposed opt-in policy, we 67 Estimates for the proposed rule available at 83 FR 36060. PO 00000 Frm 00216 Fmt 4701 Sfmt 4700 assumed that 33 percent of the clinicians who exceed at least one lowvolume threshold and submitted data to CY 2017 MIPS performance period would elect to opt-in to MIPS. We selected a random sample of 33 percent of clinicians without accounting for performance. We believe this assumption of 33 percent is reasonable because some clinicians may choose not to submit data due to performance, practice size, or resources or alternatively, some may submit data, but elect to be a voluntary reporter and not be subject to a MIPS payment adjustment based on their performance. Similar to the proposed rule (83 FR 36060), we applied a 33 percent opt-in assumption to estimate opt-in eligibility in this final rule. We sought comment on these assumptions in the proposed rule, including whether modeling eligibility only among clinicians or groups who submitted at least 6 quality measures to PQRS would be more appropriate. As we describe in more detail below, we also explored an alternate opt-in assumption where only high-performers would opt-in to MIPS. In the alternate model, we saw a difference in the maximum payment adjustment of approximately one-tenth of a percent. Given the minimal differences between the two alternatives, we elected to continue the assumption from the CY 2019 PFS proposed rule and present results with the 33 percent random opt-in for this impact analysis. This 33 percent participation assumption is identified in Table 97 as ‘‘Opt-In eligibility’’. In the final rule analysis, we estimate an additional 28,000 clinicians would be eligible through this policy for a total MIPS eligible population of approximately 798,000. The leads to an associated $66.6 billion allowed PFS charges estimated to be included in the 2019 MIPS performance period. We observed a decrease of approximately 14,000 clinicians compared to the proposed rule in the ‘‘opt-in eligibility’’ category after updating the data source and applying the finalized policies. This observed decrease in the number of clinicians that would elect to opt-in to MIPS is because there were fewer clinicians from which to randomly select for optin eligibility due to the increase in group reporting. E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60051 TABLE 97—DESCRIPTION OF MIPS ELIGIBILITY STATUS FOR CY 2021 MIPS PAYMENT YEAR USING THE PROPOSED AND FINALIZED ASSUMPTIONS *** Predicted participation status in MIPS among clinicians * Eligibility status Proposed rule estimates Final Rule estimates † Legacy data * QPP Year 1 data Number of clinicians PFS allowed charges ($ in mil) **** Number of clinicians PFS allowed charges ($ in mil) **** Required eligibility (always subject to a MIPS payment adjustment because individual clinicians exceed the low-volume threshold in all 3 criteria). Group eligibility (only subject to payment adjustment because clinicians’ groups exceed lowvolume threshold in all 3 criteria and submit as a group). Opt-In eligibility assumptions (only subject to a positive, neutral, or negative adjustment because the individual or group exceeds the lowvolume threshold in at least 1 criterion but not all 3, and they elect to opt-in to MIPS and submit data). Participate in MIPS ....... Do not participate in MIPS. 186,549 31,921 43,546 7,605 199,236 17,376 47,653 3,916 Submit data as a group 389,670 10,262 553,475 13,662 Elect to opt-in and submit data. 42,025 2,099 27,903 1,380 Total Number of MIPS Eligible Clinicians ..... Not MIPS eligible: Potentially MIPS eligible (not subject to payment adjustment for non-participation; could be eligible for one of two reasons: 1) meet group eligibility or 2) opt-in eligibility criteria). Below the low-volume threshold (never subject to payment adjustment; both individual and group is below all 3 low-volume threshold criteria). Excluded for other reasons (Non-eligible clinician type, newly enrolled, QP). .................................. 650,165 63,512 ** 797,990 66,611 Do not opt-in; or ........... Do not submit as a group. 482,574 11,695 390,244 9,290 Not applicable ............... 88,070 690 77,617 404 Not applicable ............... 302,172 13,688 209,403 9,735 Total Number of Clinicians Not MIPS Eligible. .................................. 872,816 26,073 677,264 19,429 Total Number of Clinicians (MIPS and Not MIPS Eligible). .................................. 1,522,981 89,585 1,475,254 86,040 amozie on DSK3GDR082PROD with RULES3 * Participation in MIPS defined as previously submitting quality or EHR data for PQRS. Group reporting based on 2016 PQRS group reporting. ** Updated Estimated MIPS Eligible Population. *** Facility-based eligible clinicians are not modeled separately in this table and are captured in the individual eligible category. This table does not consider the impact of the MAQI Demonstration waiver. This table also does not include clinicians impacted by the automatic extreme and uncontrollable policy (approximately 22,000 clinicians and $3.7 billion in PFS allowed charges). † These estimates reflect the finalized policies, which differ from the proposed rule (that is, change in MIPS eligible clinician types and those identified as QPs). **** Allowed charges estimated using 2016 and 2017 dollars. Low-volume threshold is calculated using allowed charges. MIPS payment adjustments are applied to the paid amount. There are approximately 390,000 clinicians who are not MIPS eligible, but could be if their practice decides to participate. We describe this group as ‘‘Potentially MIPS eligible.’’ This is the unlikely scenario in which all group practices elect to submit data as a group and all clinicians that could elect to optinto MIPS do elect to opt-in. This assumption is important because it quantifies the maximum number of MIPS eligible clinicians. When this unlikely scenario is modeled, we estimate that the MIPS eligible clinician population could be as high as 1.2 million clinicians. We observed a decrease of approximately 92,000 clinicians compared to the model in the VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 proposed rule after updating the data source and applying the finalized policies. This observed decrease is due to the increase in group reporting. Finally, there are some clinicians who would not be MIPS eligible either because they are below the low-volume threshold on all three criteria (approximately 78,000) or because they are excluded for other reasons (approximately 209,000). We observed a decrease of approximately 93,000 clinicians after updating the data source and applying the finalized policies. This observed decrease is due to much lower estimated number of newly enrolled clinicians but slightly higher number of PO 00000 Frm 00217 Fmt 4701 Sfmt 4700 QPs in the 2017 Quality Payment Program Year 1 data. Since eligibility among some clinicians is contingent on submission to MIPS as a group or election to optin, we will not know the exact number of MIPS eligible clinicians until the submission period for the CY 2019 MIPS performance period is closed. For this impact analysis, we are using the estimated population of 797,990 MIPS eligible clinicians described above. We received the following comments on our methodology: Comment: One commenter requested CMS explain how the number of clinicians affected by the proposed MIPS opt-in policy for the 2021 E:\FR\FM\23NOR3.SGM 23NOR3 60052 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations payment year was estimated. The commenter supported the proposed MIPS opt-in policy starting in 2019 but would like to know how CMS estimated the number of clinicians that would be impacted by the policy. Response: For the proposed rule, to estimate the number of clinicians that may elect to opt-in to MIPS, we randomly selected 33 percent of clinicians that met at least one but not all the low-volume criteria and submitted data to 2016 PQRS. This led to an estimated 42,025 number of clinicians that will opt-in to MIPS. For this final rule, we randomly selected 33 percent of clinicians that met at least one but not all the lowvolume criteria and submitted to CY 2017 MIPS performance period. This led to an estimated 27,903 number of clinicians that will opt-in to MIPS. We also estimated the impact if we had assumed only those who expect to perform well would elect to opt-in. In the alternate model assumption where only high performers would opt-in to MIPS, we assumed 100 percent of clinicians with final scores above the additional performance threshold would opt-in and 50 percent of clinicians above the performance threshold but below the additional performance threshold would opt-in. We observed a decrease in the budget neutral pool from $310 million to $296 comparing the model with the 33 percent random optin to the model where only highperformers opt-in. We observed a minimal impact to the maximum payment adjustment compared to the model with 33 percent random opt-in (4.7 percent versus 4.6 percent). We refer readers to section III.I.3.c.(5) of this final rule for additional results on that analysis. Because we did not see much difference in results, we present the model with the 33 percent random optin this impact analysis. Comment: One commenter recommended CMS present specialtyspecific data for exemption criteria. Specifically, the commenter recommended CMS present specialty specific information on the number of clinicians exempt from MIPS because they are newly enrolled in Medicare and/or Qualified Participants (QPs) or Partial QPs in Advanced APMs, and the number of clinicians assigned to certain special categories (for example, nonpatient facing, hospital-based, facilitybased, and ASC-based for the purposes of the ACI exemption). The commenter noted the provision of this information will allow for the assessment of how many clinicians are exempt by specialty and for member education activities. Response: We appreciate that some stakeholders would like specialty specific information; however, given the numerous assumptions for group reporting and opt-in participation, we believe presenting the overall number of MIPS eligible clinicians is the most transparent way to present the information. After consideration of the public comments, we have updated our methodology to estimate the number of MIPS eligible clinicians for the 2019 MIPS performance period/2021 MIPS payment year to account for the Quality Payment Program Year 1 data and the policies finalized in this final rule. (3) Impact of MIPS Eligibility Finalized Policies We illustrate in Table 98 68 how each finalized policy for the CY 2021 payment year affects the estimated number of MIPS eligible clinicians. The baseline is the number of individuals that would have been MIPS eligible clinicians for the 2019 MIPS performance period/2021 MIPS payment year if this regulation did not exist. In the CY 2019 PFS proposed rule (83 FR 36060), we estimated the baseline was 591,010. After updating the model to reflect the updated data sources, the new baseline population is 751,498. All incremental impact estimates are relative to this baseline. TABLE 98—INCREMENTAL CHANGE TABLE FOR FINALIZED POLICIES FOR 2021 MIPS PAYMENT YEAR Policy changes * Estimated number of MIPS eligible clinicians impacted by policy change Estimated effect of policy changes on number of MIPS eligible clinicians N/A 751,498 N/A 79,375 64,382 N/A ¥1,651 749,847 ¥0.2 79,160 64,266 ¥0.2% 20,240 770,087 2.5 N/A 65,231 1.3% 27,903 797,990 6.2 N/A 66,611 3.5% amozie on DSK3GDR082PROD with RULES3 Baseline: Applying previously finalized policy for the 2021 payment year if this regulation did not exist ......................... Policy Change 1: Low-volume threshold (LVT) determination based on covered professional services (as required by Bipartisan Budget Act of 2018) ............ Policy Change 2: Expansion of eligible clinician types to include physical therapists, occupational therapists, qualified speech-language pathologist, or qualified audiologist, clinical psychologist, and registered dietician or nutrition professional based with policy change 1 ............................................... Policy Change 3: Cumulative change of Opt-in Policy with policy changes 1 and 2 ** ................................................. Estimated % change from baseline Estimated Part B allowed charges (mil) *** Estimated PFS allowed charges (mil) *** Estimated % change in PFS from baseline * This table does not consider the impact of the MAQI Demonstration waiver and does not include clinicians impacted by the extreme and uncontrollable policy. ** Model assumption is 33 percent clinicians who are eligible will elect to opt-in. *** Allowed charges estimated using 2016 and 2017 dollars. Low-volume threshold is calculated using allowed charges. MIPS payment adjustments are applied to the paid amount. 68 Estimates for the proposed rule available at 83 FR 36061. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00218 Fmt 4701 Sfmt 4700 E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations First, as shown in Table 98, the first row shows the effect of changing the application of the MIPS payment adjustments, as required by section 51003(a)(1)(E) of the Bipartisan Budget Act of 2018 to apply them to covered professional services (services for which payment is made under, or is based on, the Medicare PFS and are furnished by an eligible clinician) rather than to items and services covered under Part B. As shown, the baseline allowed charges for Part B is $79.4 billion, compared with $64.4 billion in covered professional services, which is a difference of almost $15 billion. Beginning in the 2019 MIPS payment year, payment adjustments will only be applied to the total paid amount for covered professional services. In Table 98, under the first policy change, basing the low-volume threshold on covered professional services (services provided under the PFS rather than items and services covered under Part B) has minimal impact in terms of clinicians (less than half of one percent decrease). When the second policy change, to expand the definition of MIPS eligible clinician types, was added to the first policy change, the total effect is small. The change in the potential MIPS eligible clinician population increased by less than 3 percent and the allowed charges in the PFS increased by 1.3 percent. When the third policy change, which implements the opt-in policy, is added to the other two policies, the estimated number of MIPS eligible clinicians increases by 6.2 percent. The estimated increase in the allowed charges in the PFS is 3.5 percent. d. Estimated Impacts on Payments to MIPS Eligible Clinicians amozie on DSK3GDR082PROD with RULES3 (1) Summary of Approach In sections III.I.3.h., III.I.3.i. and III.I.3.j. of this final rule, we finalized several proposals which impact the measures and activities that impact the performance category scores, final score calculation, and the MIPS payment adjustment. We discuss these changes in more detail in section VII.F.8.d.(2) of this RIA as we describe our methodology to estimate MIPS payments for the 2021 MIPS payment year. We note that many of the MIPS policies from the CY 2018 Quality Payment Program final rule were only defined for the 2018 MIPS performance period and 2020 MIPS payment year (including the performance threshold, the additional performance threshold, the policy for redistributing the weights of the performance categories, and many VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 scoring policies for the quality performance category) which precludes us from developing a baseline for the 2019 MIPS performance period and 2021 MIPS payment year if there was no new regulatory action. Therefore, our impact analysis looks at the total effect of the finalized MIPS policy changes on the MIPS final score and payment adjustment for CY 2019 MIPS performance period/CY 2021 MIPS payment year. The payment impact for a MIPS eligible clinician is based on the clinician’s final score, which is a value determined by their performance in the four MIPS performance categories: Quality, cost, improvement activities, and Promoting Interoperability. As described in the CY 2019 PFS proposed rule (83 FR 36061), the performance and participation data submitted for the 2017 MIPS performance period were not available to estimate the final score and the projected payment adjustments for MIPS eligible clinicians. This analysis has been updated with the Quality Payment Program Year 1 data and those results are presented in this final rule. We refer readers to CY 2019 PFS proposed rule (83 FR 36061 through 36066) for additional details on how we estimated the final scores and payment adjustments in the proposed rule. The estimated payment impacts presented in this final rule reflect averages by practice size based on Medicare utilization. The payment impact for a MIPS eligible clinician could vary from the average and would depend on the combination of services that the MIPS eligible clinician furnishes. The average percentage change in total revenues would be less than the impact displayed here because MIPS eligible clinicians generally furnish services to both Medicare and non-Medicare patients; this program does not impact payment from nonMedicare patients. In addition, MIPS eligible clinicians may receive Medicare revenues for services under other Medicare payment systems, such as the Medicare Federally Qualified Health Center Prospective Payment System or Medicare Advantage that would not be affected by MIPS payment adjustment factors. (2) Methodology To Assess Impact To estimate participation in MIPS for the CY 2019 Quality Payment Program for this final rule, we used CY 2017 Quality Payment Program Year 1 performance period data. Our scoring model includes the 797,990 estimated number of MIPS eligible clinicians as described in section VII.F.8.c of this RIA. PO 00000 Frm 00219 Fmt 4701 Sfmt 4700 60053 To estimate the impact of MIPS on eligible clinicians, we used the Quality Payment Program Year 1 submission data, including data submitted for the quality, improvement activities, and advancing care information performance categories, CAHPS for MIPS and CAHPS for ACOs, the total per capita cost measure, Medicare Spending Per Beneficiary (MSPB) measures and other data sets.69 We calculated a hypothetical final score for the 2019 MIPS performance period/2021 MIPS payment year for each MIPS eligible clinician based on quality, cost, Promoting Interoperability, and improvement activities performance categories. Starting in CY 2018 MIPS performance period, solo practitioner or a group of 10 or fewer eligible clinicians may elect to participate in MIPS as a virtual group (82 FR 53604). We had two virtual groups register for the 2018 performance period, of which one had all its participants participating in a MIPS APM for the 2018 performance period. While we anticipate an increase in the number of virtual groups for the 2019 MIPS performance period, we did not attempt to model virtual groups in this model as the participants in one virtual group who are in a MIPS APM would receive the MIPS APM score which left just one virtual group to measure. (a) Methodology To Estimate the Quality Performance Category Score We estimated the quality performance category score using measures submitted to MIPS for the 2017 performance period. For the quality measures, we started with the assigned measure achievement points assigned for the 2017 MIPS performance period. As finalized as proposed in III.I.3.i.(1)(b)(iii)(A) of this final rule, we applied a 3-point floor for measures that cannot be reliably scored against a baseline benchmark in the 2019 MIPS performance period. As described in section III.I.3.h.(2)(b)(iii) of this final rule, we finalized the proposal to remove many measures that were previously able to be reported in PQRS and in previous MIPS performance periods. For our estimates, we assumed that clinicians who reported Medicare Part B claims, eCQM, MIPS CQM and QCDR measures that are removed would find alternate measures; therefore, we assigned points to these measures and included them in our scoring model. For CY 2019, we maintained the policies for 69 2016 PQRS and Value Modifier data was used for the improvement score for the quality performance category. E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 60054 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations scoring measures that do not meet the quality category requirements (case minimum, benchmark, and data completeness) as described in the CY 2018 Quality Payment Program final rule (82 FR 53727 through 53730). As finalized in the CY 2018 Quality Payment Program final rule, we also applied a 7-point cap for measures that are topped out for two or more years (82 FR 53721 through 53727). As stated in section III.I.3.h.(2)(a)(iii)(A)(bb) of this final rule, we finalized the proposal to remove several Web Interface measures. For that collection type, which has a standard set of measures, we estimated performance on the measures that we propose to continue. As finalized in sections III.I.3.i.(1)(b)(ix) and (x) of this final rule, we maintained the cap on bonus points for high-priority measures and end-to-end electronic bonus points at 10 percent of the denominator and, beginning with the 2019 MIPS performance period, discontinue high priority bonus points for CMS Web Interface Reporters. Because we are able to use MIPS performance data in our models, we assigned 1 point for each measure that was submitted with endto-end electronic reporting with a cap of 10 percent of the total possible measure achievement points. To be consistent with our small practice bonus finalized policy in section III.I.3.i.(1)(b)(viii) of this final rule, we added 6 measure achievement points to the quality performance category score for small practices that had a quality performance category score greater than 0 points. As finalized in the CY 2018 Quality Payment Program final rule (82 FR 53625 through 52626) and further discussed in III.I.3.h.(2)(a)(iii) of this final rule, we are allowing MIPS eligible clinicians and groups to submit data collected via multiple collection types within a performance category beginning with the 2019 performance period. The requirements for the performance categories remain the same regardless of the number of collection types used. We do not apply the validation process that is discussed in section III.I.3.i.(1)(b)(vii) of this final rule. To estimate the impact of improvement for the quality performance category, we estimated a quality performance category percent score using 2019 MIPS data, 2015 and 2018 CAHPS for ACOs and MIPS data, and 2016 PQRS VM data. For MIPS eligible clinicians with an estimated quality performance category score less than or equal to a 30 percent score in the previous year, we compared 2019 VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 performance to an assumed 2018 quality score of 30 percent for their improvement score as described in III.I.3.i.(1)(b)(xiii) of this final rule. Due to data limitations, we are unable to model all the finalized policies in this rule. We are not able to incorporate the policy to reduce the denominator for the quality performance category score by 10 points for groups that registered for CAHPS for MIPS but were unable to report due to insufficient sample size as discussed in section III.I.3.i.(1)(b)(iii)(B) of this final rule. We also did not apply the finalized scoring policy for measures that are significantly impacted by clinical guideline or other changes discussed in section III.I.3.i.(1)(b)(vi) of this final rule. Our model applied the MIPS APM scoring standards finalized in section III.I.3.h.(6) of this final rule to quality data from MIPS eligible clinicians that participated in the Shared Savings Program, and the Next Generation ACO Model in 2017. (b) Methodology To Estimate the Cost Performance Category Score In section III.I.3.h.(3)(b)(ii) of this final rule, we finalized the proposal to add 8 episode-based measures to the cost performance category beginning with the 2019 performance period. For the episode-based measures, we used the episode specifications proposed in the CY 2019 PFS proposed rule (83 FR 35902 through 35903) and claims data from June 2016 through May 2017. As discussed in section III.I.3.h.(3)(b)(ii) of this final rule, we made updates to the specifications for three episode measures. Due to timing constraints we were not able to incorporate the updated specifications into this impact analysis; however, we anticipate that the updates will only have a marginal effect on the cost measure scores. We estimated the cost performance category score using the total per capita cost measure and Medicare Spending Per Beneficiary (MSPB) measures from the CY 2017 Quality Payment Period Year 1 data that was presented in the MIPS feedback reports. Cost measure scores were used only when the associated case size met or exceeded the previously finalized or newly finalized case minimum: 20 for the total per capita cost measure, 35 for MSPB, 10 for procedural episodes, and 20 for acute medical inpatient medical condition episodes. The cost measures are computed for both the TIN/NPI and the TIN. For clinicians participating as individuals, the TIN/NPI level score was used if available and if the minimum case size was met. For clinicians participating as groups, the TIN level PO 00000 Frm 00220 Fmt 4701 Sfmt 4700 score was used, if available, and if the minimum case size was met. For clinicians with no measures meeting the minimum case requirement, we did not estimate a score for the cost performance category, and the weight for the cost performance category was reassigned to the quality performance category. The raw cost measure scores were mapped to scores on the scale of 1–10, using benchmarks based on all measures that met the case minimum during the relevant performance period. For the episode-based cost measures, separate benchmarks were developed for TIN/NPI level scores and TIN level scores. For each clinician, a cost performance category score was computed as the average of the measure scores available for the clinician. (c) Methodology To Estimate the Facility-Based Measurement Scoring As discussed in section III.I.3.i.(1)(d) of this final rule, we are implementing facility-based measurement for the 2019 MIPS performance period. In facilitybased measurement, we determine the eligible clinician’s MIPS score based on Hospital VBP Total Performance Score for eligible clinicians or groups who meet the eligibility criteria, which we designed to identify those who primarily furnish services within a hospital. Given that we are not requiring eligible clinicians to opt-in to facilitybased measurement, it is possible that a MIPS eligible clinician or a group is automatically eligible for facility-based measurement but they participate in MIPS as an individual or a group. In these cases, we use the higher combined quality and cost performance category score from facility-based scoring compared to the combined quality and cost performance category score from MIPS submission based scoring. Data was not available to attribute specific Hospital VBP Total Performance Score to MIPS eligible clinicians, hence we made the following assumptions. For MIPS eligible clinicians and groups who are eligible for facility-based measurement and who submitted quality data to the Quality Payment Program for the 2017 MIPS performance period, we did not estimate a facility-based score. We instead calculated a MIPS quality and cost score based on the available quality measures and cost data. Some clinicians who submitted Quality Payment Program quality data may receive a higher combined quality and cost score through facility-based measurement, but we are unable to identify those clinicians due to data limitations and therefore believe the score based on E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations amozie on DSK3GDR082PROD with RULES3 their submitted data is more likely to reflect their performance. For MIPS eligible clinicians that did not submit data to the Quality Payment Program for the 2017 MIPS performance period and were eligible for facilitybased measurement, we estimated a facility-based score by taking the median MIPS quality and cost performance score. We believe it is important to develop an estimate for this cohort because we would have otherwise assigned this group a quality performance category percent score of zero percent which we believe would underestimate their MIPS final score. Given the data limitations in assigning a specific hospital score to a clinician, we selected the median MIPS quality and cost performance scores as that represents the quality and cost performance category scores that a clinician working in a hospital with median performance would receive. (d) Methodology To Estimate the Promoting Interoperability Performance Category Score As discussed in section III.I.3.h.(5)(d)(ii) of this final rule, we finalized the proposal to modify the measures and scoring for the Promoting Interoperability performance category score. We simplified scoring by eliminating the concept of base and performance scores and focusing on a smaller set of measures which are scored on performance. We estimated Promoting Interoperability performance category scores using the advancing care information performance category data from the CY 2017 Quality Payment Period Year 1 data. The Promoting Interoperability performance category scores were based on the individual level for individual submissions and on the group level for clinicians that were part of a group submission or part of an APM entity. For the e-Prescribing objective, we only estimated the e-Prescribing measure and did not assume any bonus points for the Query of Prescription Drug Monitoring Program (PDMP) or the Verify Opioid Treatment Agreement measures. To estimate the e-Prescribing measure, we used the reported numerator and denominator values for the e-Prescribing measure for the advancing care information performance category, unless a measure exclusion applied. For the Health Information Exchange objective, we used the required measures in the Health Information Exchange objective from the advancing care information performance category to proxy performance for the two finalized measures in the Promoting VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 Interoperability objective. We used the Send Summary of Care measure and the Health Information Exchange transition measure for the Support Electronic Referral Loops by Sending Health Information measure. For MIPS eligible clinicians that reported data using 2015 CEHRT, we used the Request/Accept Summary of Care measure for the Support Electronic Referral Loops by Receiving and Incorporating Health Information. If this information was not available, then we used just the Send Summary of Care measure. If there was an exclusion for the Send Summary of Care measure or the Health Information Exchange transition measure, then for purpose of this model, we reweighted the measure to the Patient Electronic Access objective. For the Provider to Patient Exchange objective, we used the Provide Patient Access measure to estimate performance for the finalized Provide Patients Electronic Access to Their Health Information measure. For the Public Health and Clinical Data Exchange objective, we estimated the score by using the reported responses for the following advancing care information measures: Immunization Registry Reporting, Syndromic Surveillance Reporting, Electronic Case Reporting, Public Health Registry Reporting, Clinical Data Registry Reporting and Specialized Registry Reporting. To calculate the Promoting Interoperability performance category, we summed the performance category measure scores and divided the total sum by the total number of possible points (100), as described in section III.I.3.i.(1)(d) of this final rule. As discussed in section III.I.3.i.(1)(d) of this final rule, a TIN/NPI must report on all required measures in the Promoting Interoperability performance category and complete all actions included in the Security Risk Analysis measure during the year to receive a non-zero performance category score. For APM Entities, we aggregated the scores of the participants consistent with the requirements for the 2017 MIPS performance period. For eligible clinicians who did not submit a required Promoting Interoperability measure and did not complete all actions included in the Security Risk Analysis measure, we evaluated whether the MIPS eligible clinician could have their Promoting Interoperability performance category reweighted and applied the reweighting policies described in section III.I.3.h.(5)(d) of this final rule. For the Registry Reporting measures, which did not have an exclusion defined for the PO 00000 Frm 00221 Fmt 4701 Sfmt 4700 60055 2017 MIPS performance period, we assumed that failure to submit data or submissions with all ‘‘No’’ answers implied a request for exclusion. A group was only reweighted for the Promoting Interoperability performance category if all the TIN/NPIs were eligible for reweighting, thereby reweighting only applying to 24 percent of MIPS eligible clinicians as opposed to 62 percent of MIPS eligible clinicians scores in the CY 2019 PFS proposed rule (83 FR 36063) in which Promoting Interoperability was always assessed at the individual level. As finalized in the CY 2017 (81 FR 77069 through 77070) and CY 2018 (82 FR 53625 through 52626) Quality Payment Program final rules, the Promoting Interoperability performance category weight is set equal to 0 percent, and the weight is redistributed to the quality or improvement activities performance category for non-patient facing MIPS eligible clinicians, hospitalbased MIPS eligible clinicians, ASCbased MIPS eligible clinicians, or those who request and are approved for a significant hardship or other type of exception, including a significant hardship exception for small practices, or clinicians who are granted an exception based on decertified EHR technology (82 FR 53780 through 53786). We also finalized in section III.I.3.h.(5)(h) of this final rule to continue automatic reweighting for NPs, PAs, CNSs and CRNAs and to add an automatic reweighting policy for physical therapists, occupational therapist, speech-language pathologists, audiologists, clinical psychologists, and registered dietitians or nutrition professionals, which we have incorporated into our model. We used the non-patient facing and hospitalbased indicators and specialty and small practice indicators as calculated in the initial MIPS eligibility run for the 2017 MIPS performance period (81 FR 77069 through 77070). For significant hardship exceptions, we used the approved significant hardship file for the 2017 MIPS performance period. If a TIN/NPI did not report on all required measures and did not qualify for reweighting for a required measure, then their Promoting Interoperability performance category score was set to zero percent. (e) Methodology To Estimate the Improvement Activities Performance Category Score We modeled the improvement activities performance category score based on CY 2017 Quality Payment Period Year 1 data and APMs participation in the 2017 MIPS performance period. We did not make E:\FR\FM\23NOR3.SGM 23NOR3 60056 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations any policy changes that impact scoring for the improvement activities performance category. Our model identified participants in APMs during the 2017 performance period, including but not limited to those in the Shared Savings Program, Next Generation ACO Model, and assigned them an improvement activity score of 100 percent, consistent with our policy to assign an improvement activities score of 100 percent to ACO participants who were not excluded due to being QPs. Clinicians and groups not participating in a MIPS APM were assigned their CY 2017 Quality Payment Period Year 1 improvement activities performance category score. amozie on DSK3GDR082PROD with RULES3 (f) Methodology To Estimate the Complex Patient Bonus In sections III.I.3.i.(2)(a)(ii) of this final rule, we finalized the proposed policy to continue the complex patient bonus. Consistent with the policy to define complex patients as those with high medical risk or with dual eligibility, our scoring model calculated the bonus by using the average Hierarchical Condition Category (HCC) risk score, as well as the MIPS eligible clinician’s patients dual eligible proportion calculated for each NPI in the 2016 Physician and Other Supplier Public Use File. The dual eligible proportion for each MIPS eligible clinician was multiplied by 5. We also generated a group average HCC risk score by weighing the scores for individual clinicians in each group by the number of beneficiaries they have seen. We generated group dual eligible proportions using the weighted average dual eligible patient ratio for all MIPS eligible clinicians in the groups, which was then multiplied by 5. The complex patient bonus was calculated by adding together the average HCC risk score and the percent of dual eligible patients multiplied by 5, with a 5-point cap. (g) Methodology To Estimate the Final Score As finalized in sections III.I.3.h.(2)(a)(ii), III.I.3.h.(3)(a), III.I.3.h.(4)(a), III.I.3.h.(5)(d)(i) and summarized in section III.I.3.i.(2)(b) of this final rule, our model assigns a final score for each TIN/NPI by multiplying each performance category score by the corresponding performance category weight, adding the products together, multiplying the sum by 100 points, and adding the complex patient bonus. After adding any applicable bonus for complex patients, we reset any final scores that exceeded 100 points equal to 100 points. For MIPS eligible clinicians who were assigned a weight of zero VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 percent for the Promoting Interoperability due to a significant hardship or other type of exception, the weight for the Promoting Interoperability performance category was redistributed to the quality performance category. For MIPS eligible clinicians who did not have a cost performance category score, the weight for the cost performance category was redistributed to the quality performance category. In our scoring model, we did not address scenarios where a zero percent weight would be assigned to the quality performance category or the improvement activities performance category. (h) Methodology To Estimate the MIPS Payment Adjustment As described in the CY 2018 Quality Payment Program final rule (82 FR 53785 through 53787), we applied a hierarchy to determine which final score should be used for the payment adjustment for each MIPS eligible clinician when more than one final score is available (for example if a clinician qualifies for a score for an APM entity and a group score, we select the APM entity score). We then calculated the parameters of an exchange function in accordance with the statutory requirements related to the linear sliding scale, budget neutrality, minimum and maximum adjustment percentages and additional payment adjustment for exceptional performance (as finalized under § 414.1405), using a performance threshold of 30 points and the additional performance threshold of 75 points (as finalized in sections III.I.3.j.(2) and III.I.3.j.(3) of this final rule). We used these resulting parameters to estimate the positive or negative MIPS payment adjustment based on the estimated final score and the PFS paid amount. We considered other performance thresholds which are discussed in section VII.G. of this RIA. (3) Impact of Payments by Practice Size Using the assumptions provided above, our model estimates that $310 million would be redistributed through budget neutrality and that the maximum positive payment adjustments are 4.7 percent after considering the MIPS payment adjustment and the additional MIPS payment adjustment for exceptional performance. The observed decrease in the funds available for redistribution and the maximum positive payment adjustment from the proposed rule to the final rule is due to the change in the data sources used to estimate final scores for MIPS eligible PO 00000 Frm 00222 Fmt 4701 Sfmt 4700 clinicians and the decrease in the additional performance threshold. The use of 2017 Quality Payment Program Year 1 data to estimate the impact of the 2019 Quality Payment Program Year 3 finalized policies led to lower average final scores compared to the proposed rule. The main contributors to the lower estimated final scores were the changes in the estimated quality and Promoting Interoperability performance categories scores. The average quality scores were lower because some of the group reporters did not have quality data. As described in section VII.F.8.c.(2) of this final rule, we previously identified group reporters based on the submission of quality data submitted to PQRS; therefore, all group reporters submitted quality data and had a quality score. As a result of the 2017 Quality Payment Program Year 1 data, we can identify group reporters through submissions for the improvement activities or the Promoting Interoperability performance category who may not have submitted quality data. Therefore, these new groups in the estimated MIPS population received a zero (or close to zero) quality performance category score for not submitting quality data. Table 99 shows the impact of the payments by practice size and whether clinicians are expected to submit data to MIPS.70 We estimate that a smaller proportion of clinicians in small practices (1–15 clinicians) who participate in MIPS will receive a positive or neutral payment adjustment compared to larger size practices. Overall, clinicians in small practices participating in MIPS would receive a 1.2 percent increase in their paid amount, which is similar to the payment amount received by MIPS eligible clinicians in practices with 16 to 24 and 25 to 99 clinicians. After considering the positive adjustments and subtracting the negative adjustments, eligible clinicians in small practices would have an increase in funds which is consistent with all MIPS eligible clinicians. Table 99 also shows that 91.2 percent of MIPS eligible clinicians that participate in MIPS are expected to receive positive or neutral payment adjustments. The combined impact of negative and positive adjustments and exceptional performance payment as percent of paid 70 The proposed rule estimated MIPS participation and performance using historical PQRS and EHR data because MIPS CY 2017 performance period data were not available in time for analysis in the proposed rule (83 36058 through 36066). This final rule presents the results from analysis of MIPS CY 2019 performance period data. Previous estimates are available in the proposed (83 FR 36066). E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations amount among those that do not submit data to MIPS was not the maximum negative payment adjustment possible because not all MIPS eligible clinicians that do not submit to MIPS receive a final score of zero. Indeed, some MIPS eligible clinicians that do not submit data to MIPS may receive final scores above zero through the cost performance category, which does not require submission to MIPS. Among those who we estimate would not submit data to MIPS, 90 percent are in small practices (15,680 out of 17,376 clinicians). To 60057 address participation concerns, we have policies targeted towards small practices including technical assistance and special scoring policies to minimize burden and facilitate small practice participation in MIPS or APMs. TABLE 99—MIPS ESTIMATED PAYMENT YEAR 2021 IMPACT ON TOTAL ESTIMATED PAID AMOUNT BY PARTICIPATION STATUS AND PRACTICE SIZE * a Number of MIPS eligible clinicians Practice size * Percent MIPS eligible clinicians with positive or neutral payment adjustment (percent) Percent MIPS eligible clinicians with a positive adjustment with exceptional payment adjustment (percent) Percent MIPS eligible clinicians with negative payment adjustment (percent) Combined Impact of negative and positive adjustments and exceptional performance payment as percent of paid amount * * (percent) Among those submitting data * * * (1) (2) (3) (4) 1–15 ................................................. 16–24 ............................................... 25–99 ............................................... 100+ ................................................. Overall ............................................. 140,251 41,226 185,140 413,997 780,614 80.1 86.1 89.8 96.1 91.2 47.2 41.4 48.6 69.0 58.8 19.9 13.9 10.2 3.9 8.8 1.2 1.1 1.3 2.0 1.5 0.0 0.0 0.0 0.0 0.0 100.0 100.0 100.0 100.0 100.0 ¥6.3 ¥6.6 ¥6.6 ¥6.9 ¥6.4 Among those not submitting data (1) (2) (3) (4) 1–15 ................................................. 16–24 ............................................... 25–99 ............................................... 100+ ................................................. Overall ............................................. 15,680 629 860 207 17,376 0.0 0.0 0.0 0.0 0.0 amozie on DSK3GDR082PROD with RULES3 * Practice size is the total number of TIN/NPIs in a TIN. ** 2016 and 2017 data used to estimate 2019 performance period payment adjustments. Payments estimated using 2016 and 2017 dollars. *** Includes facility-based clinicians whose quality data is submitted through hospital programs. a This table does not account for clinicians that are in the MAQI Demonstration waiver. The following is a summary of the public comments received regarding the estimated impact on payments for MIPS eligible clinicians: Comment: A few commenters encouraged CMS to use Year 1 MIPS participation data to inform changes to the program, citing that actual QPP data is needed for assessing the best ways to improve the program and how these changes will impact clinicians financially. Response: We thank the commenter for this suggestion. As described in this RIA for this final rule, the 2017 Quality Payment Program Year 1 data were available in time to assess impact of the finalize policies and are now presented in this final rule. Comment: A few commenters recommended CMS present specialty specific tables. Specifically, they requested the estimated payment impact table by specialty as presented in previous years and additional performance data by specialty on each performance category (Data on reporting and performance rates for quality VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 measures (similar to what was released via the PQRS Experience Reports); Statistics on clinical improvement activities reported; Statistics on clinician attribution to cost measures and performance on cost measures.). This would allow for better understanding of MIPS for their stakeholders. Response: We chose to only present the payment impact by practice size in this final rule; however, we may provide additional analyses via the Quality Payment Program website or other forums. After consideration of public comments, we have updated our analyses to incorporate the Quality Payment Program Year 1 data and the final policies. PO 00000 Frm 00223 Fmt 4701 Sfmt 4700 e. Potential Costs of Compliance With the Promoting Interoperability and Improvement Activities Performance Categories for Eligible Clinicians (1) Potential Costs of Compliance With Promoting Interoperability Performance Category In section III.I.3.h.(5)(c) of this final rule, we discussed the requirement to use EHR technology certified to the 2015 Edition beginning with the 2019 MIPS performance period for the Promoting Interoperability performance category. As discussed in section V.B.3 of this final rule, we assumed a slight decrease in overall information collection burden costs for the Promoting Interoperability performance category related to having fewer measures to submit. With respect to any costs unrelated to data submission, although this final rule would require some investment in systems updates, our policy prior to this regulation as reflected in § 414.1305, is that 2015 Edition CEHRT will be required beginning with the 2019 MIPS E:\FR\FM\23NOR3.SGM 23NOR3 60058 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations performance period/2021 MIPS payment year (82 FR 53671). Therefore, we do not anticipate any additional costs due to this regulation. The following is a summary of the public comments received regarding these assumptions: Comment: A few commenters stated that complying with Promoting Interoperability performance category is a financial burden for many clinicians due to their practice size and their administrative capability, and the costs required by the EMR and EHR vendors. One commenter suggested that state and federal legislation ought to take these challenges into account, while another commenter suggested CMS work with stakeholders to establish mechanisms for providers to be compensated for creating interoperable data. Response: We reiterate that this policy was finalized in the CY 2018 Quality Payment Program final rule (82 FR 53671) and thus this is not a new obligation for this final rule. We do have policies that recognize challenges, such as significant hardship exceptions for small practices. After consideration of public comments, we are not making any modifications on our potential cost for compliance with Promoting Interoperability performance category. amozie on DSK3GDR082PROD with RULES3 (2) Potential Costs of Compliance With Improvement Activities Performance Category Under the policies established in the CY 2017 Quality Payment Program final rule, the costs for complying with the improvement activities performance category requirements could have potentially led to higher expenses for MIPS eligible clinicians. Costs per fulltime equivalent primary care clinician for improvement activities will vary across practices, including for some activities or certified patient-centered medical home practices, in incremental costs per encounter, and in estimated costs per (patient) member per month. Costs for compliance with previously finalized policies may vary based on panel size (number of patients assigned to each care team) and location of practice among other variables. For example, Magill (2015) conducted a study of certified patient-centered medical home practices in two states.71 That study found that costs associated with a full-time equivalent primary care clinician, who was associated with certified patient-centered medical home practices, varied across practices. 71 Magill et al. ‘‘The Cost of Sustaining a PatientCentered Medical Home: Experience from 2 States.’’ Annals of Family Medicine, 2015; 13:429–435. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 Specifically, the study found an average cost of $7,691 per month in Utah practices, and an average of $9,658 in Colorado practices. Consequently, incremental costs per encounter were $32.71 for certified patient-centered medical home practices in Utah and $36.68 in Colorado (Magill, 2015). The study also found that the average estimated cost per patient member, per month, for an assumed panel of 2,000 patients was $3.85 in Utah and $4.83 in Colorado. However, given the lack of comprehensive historical data for improvement activities, we are unable to quantify those costs in detail at this time. The findings presented in these papers have not changed. We have improvement activities information from the 2017 performance period, but additional analysis would be required before using that data to report the costs and benefits of implementing the improvement activities; and we are not able to do this in time for publication of this final rule. We have considered factors that also contribute to the difficulty of identifying compliance costs for the improvement activities performance category in the CY 2018 Quality Payment Program final rule (82 FR 53845). We believe that because we finalized an opt-in policy (as described in section II.C.2.c of this final rule), we would add approximately 28,000 additional clinicians to the MIPS eligible clinicians. In section V.B.4 of this final rule, we assumed that those who have elected to opt-in have already been voluntary reporters in MIPS and would not have additional compliance costs as a result of this regulation. Thus, we believe the overall potential cost of compliance would not increase because of this final rule. Further, we anticipate that the vast majority of clinicians submitting improvement activities data to comply with existing MIPS policies could continue to submit the same activities under the policies established in this final rule. Previously finalized improvement activities continue to apply for the current and future years unless otherwise modified per rulemaking (82 FR 54175). We refer readers to Table H in the Appendix of the CY 2017 Quality Payment Program final rule (81 FR 77177 through 77199) and Tables F and G in the Appendix of the CY 2018 Quality Payment Program final rule (82 FR 54175 through 54229) for our previously finalized 112 improvement activities established in the Improvement Activities Inventory. In section III.I.3.h.(4)(d)(ii) of this final rule, we finalized 6 new improvement PO 00000 Frm 00224 Fmt 4701 Sfmt 4700 activities, 5 modifications, and 1 removal of an existing activity. Similarly, we believe that third parties who submit data on behalf of clinicians who prepared to submit data in the transition year will not incur additional costs as a result of this final rule. We requested comments that provide additional information that would enable us to quantify the costs, costs savings, and benefits associated with implementation of improvement activities in the inventory, but did not receive comments with information that would enable us to quantify the costs, costs savings, and benefits associated with the implementation and compliance with the requirements of the improvement activities performance category: In section III.I.3.h.(4)(e) of this final rule, we discuss how eligible clinicians can participate in the CMS study on burdens associated with reporting quality measures for each MIPS performance period. Eligible clinicians who are interested in participating can sign up and an adequate sample size is then selected by CMS from these potential participants. In the CY 2018 Quality Payment Program final rule, the sample size for the CY 2018 performance period was set at a minimum of 102 MIPS eligible clinicians (81 FR 77196). Each study participant is required to complete a survey prior to submitting MIPS data and another survey after submitting MIPS data. In section III.I.3.h.(4)(e) of this final rule, for the CY 2019 performance period, we finalized the increase to the sample size to a minimum of 200 MIPS eligible clinicians. However, we made the focus group a requirement only for a selected subset of the study participants, using purposive sampling and random sampling methods, beginning with the CY 2019 performance period and future years. Completing each survey is estimated to require approximately 15 minutes; therefore, the annual hourly burden per participant is approximately 30 minutes. The annual hourly burden associated with the increase in sample size by 98 clinicians (from 102 clinicians to 200) is estimated to be 49 hours (98 clinicians × 0.5 hours). Using the hourly rate for physicians in section V.A of this final rule, the total estimated annual cost burden is estimated to be $10,116 ($206.44/hour × 49 hours). While the sample size of the study is increasing, we did not make a change to the sample size of MIPS eligible clinicians participating in the focus group, so no burden is estimated for participating in that activity. We did E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations receive a comment on the burden associated with the study. amozie on DSK3GDR082PROD with RULES3 f. Assumptions & Limitations We note several limitations to our estimates of MIPS eligible clinicians’ eligibility and participation, negative MIPS payment adjustments, and positive payment adjustments for the 2021 MIPS payment year. We based our analyses on the data prepared to support the 2018 performance period initial determination of clinician and special status eligibility (available via the NPI lookup on qpp.cms.gov),72 participant lists using the APM Participation List for the first snapshot date of the 2018 QP performance period, CY 2017 Quality Payment Program Year 1 data and CAHPS for ACOs. The scoring model results presented in this final rule assume that CY 2017 Quality Payment Program Year 1 data submissions and performance are representative of CY 2017 Quality Payment Program Year 3 data submissions and performance. The scoring model does not reflect the growth in Advanced APM participation between 2018 and 2019 (Quality Payment Program Years 2 and 3) because that data is not available at the detailed level needed for our scoring analysis. The estimated performance for CY 2019 MIPS performance period using Quality Payment Program Year 1 data may be underestimated because the performance threshold to avoid a negative payment adjustment for the 2017 MIPS performance period/2019 MIPS payment year was significantly lower (3 out of 100 points) than the performance threshold for the 2019 MIPS performance period/2021 MIPS payment year (30 out of 100). We anticipate clinicians may submit more performance categories to meet the higher performance threshold to avoid a negative payment adjustment. In our MIPS eligible clinician assumptions, we assumed that 33 percent of the opt-in eligible clinicians that participated in the CY 2017 Quality Payment Program Year 1 would elect to opt-in to the MIPS program. It is difficult to predict whether clinicians will elect to opt-in to participate in MIPS with the finalized policy. There are additional limitations to our estimates: (1) We only estimated the potential impact of facility-based scoring for MIPS eligible clinicians that are eligible for facility-based measurement and would have a quality 72 The time period for this eligibility file (September 1, 2016 to August 31, 2017) maximizes the overlap with the performance data in our model. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 performance category score of zero from failure to submit quality data; (2) because we used historic data, we assumed participation in the three performance categories in MIPS Year 1 would be similar to MIPS Year 3 performance; and (3) to the extent that there are year-to-year changes in the data submission, volume and mix of services provided by MIPS eligible clinicians, the actual impact on total Medicare revenues will be different from those shown in Table 99. Due to the limitations described, there is considerable uncertainty around our estimates that is difficult to quantify in detail. 9. Medicare Shared Savings Program; Accountable Care Organizations— Pathways to Success This final rule includes certain provisions originally proposed for the Medicare Shared Savings Program (Shared Savings Program) in a proposed rule titled ‘‘Medicare Program; Medicare Shared Savings Program; Accountable Care Organizations—Pathways to Success’’ (hereinafter referred to as the ‘‘August 2018 proposed rule’’) that appeared in the Federal Register on August 17, 2018 (83 FR 41786). As described in section V. of this final rule, certain provisions of the August 2018 proposed rule are being finalized in this final rule in order to ensure that certain payment and policy changes for the Medicare Shared Savings Program are in place prior to the start of performance years under the program that begin on January 1, 2019. In a forthcoming final rule, we anticipate summarizing and responding to public comments on the remaining proposals in the August 2018 proposed rule that are not addressed in this final rule. The most consequential of the changes to the Medicare Shared Savings Program being finalized in this final rule is the option for existing ACOs whose agreement periods expire on December 31, 2018, to elect an extension to their current agreement period for a fourth performance year, defined as the period from January 1, 2019, through June 30, 2019. Absent the voluntary 6-month extension as finalized in this rule, approximately 203 ACOs would be required to leave the program at least temporarily until the availability of an opportunity to enter a new agreement period for program participation. We estimate that up to 200 ACOs would elect the extension for the first 6 months of 2019, and therefore, would continue to improve care coordination and efficiency, and have the opportunity to receive shared savings for such period estimated to total approximately $170 PO 00000 Frm 00225 Fmt 4701 Sfmt 4700 60059 million. As noted in the August 2018 proposed rule (83 FR 41922), we assumed that ACOs dropping out of the program may continue to produce residual savings in certain years following their exit from the program because of efficient practices put in place that may continue even after participation in the program ends. Therefore, while we estimate that ACOs electing the extension would produce additional savings on claims exceeding the cost of the anticipated $170 million in shared savings payments for the extension period, we note that lesser residual claims savings would also be expected for the baseline where such ACOs are not allowed to extend their participation in the program in the first 6 months of 2019 and therefore would not earn shared savings payments for that period. However, when considering the residual difference in savings on claims attributable to the 6-month extension period over the 12 months following the end of the extension we estimate that the $170 million in shared savings payments for the extension period would be fully offset by the effect of the extension on preserving a higher savings trajectory than the up to 200 ACOs that are expected to elect the extension would have exhibited absent the extension. Lastly, we note that the modifications to the Shared Savings Program finalized in this rule that rely on the authority of section 1899(i)(3) of the Act, including most notably the methodology for determining the financial performance for the 6-month performance year from January 1, 2019, through June 30, 2019, for ACOs that voluntarily elect the extension, based on the entire 12-month CY 2019 and pro-rating the amount of any shared savings or shared losses to reflect the ACO’s participation during a 6-month period, comply with requirements of section 1899(i)(3)(B). The considerations we described in the August 2018 proposed rule (83 FR 41851) (as well as those considerations discussed in section V.B.1. of this final rule) were relevant in making this determination. Specifically, we do not believe that the methodology for determining the financial performance of ACOs in a 6-month performance year from January 1, 2019, through June 30, 2019, would result in an increase in spending beyond the expenditures that would otherwise occur under the statutory payment methodology prescribed in section 1899(d) of the Act. Finalizing the voluntary 6-month extension for ACOs whose agreement periods expire on December 31, 2018, supports continued participation by these ACOs, and therefore also allows E:\FR\FM\23NOR3.SGM 23NOR3 60060 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations for lower growth in Medicare FFS expenditures based on projected participation trends. The extension is estimated to produce net savings over the baseline non-extension scenario when considering the residual benefit to savings on claims for Parts A and B services over a period of one or more years after the end of the 6-month extension period. Further, we believe the approach we are finalizing for determining the performance of ACOs for the 6-month performance year from January 1, 2019, through June 30, 2019, would continue to lead to improvement in the quality of care furnished to Medicare FFS beneficiaries. As described in section V.B.1.c.4. of this final rule, the approach to measuring ACO quality performance for the 6month performance year from January 1, 2019, through June 30, 2019, based on quality data reported for CY 2019, would maintain accountability for the quality of care ACOs provide to their assigned beneficiaries. Participating ACOs would have an incentive to perform well on the quality measures in order to maximize any shared savings they may receive and minimize any shared losses they must pay in tracks where the loss sharing rate is determined based on the ACO’s quality performance. The anticipated forthcoming final rule will provide a detailed estimate of the impact of all other changes that may be finalized from the August 2018 proposed rule. G. Alternatives Considered This final rule contains a range of policies, including some provisions related to specific statutory provisions. The preceding preamble provides descriptions of the statutory provisions that are addressed, identifies those policies when discretion has been exercised, presents rationale for our proposed policies and, where relevant, alternatives that were considered. For purposes of the payment impact on PFS services of the policies contained in this final rule, we presented the estimated impact on total allowed charges by specialty. The alternatives we considered, as discussed in the preceding preamble sections, would result in different payment rates, and therefore, result in different estimates than those shown in Table 94 (CY 2019 PFS Estimated Impact on Total Allowed Charges by Specialty). 1. E/M Coding and Payment Alternatives Considered For the CY 2019 PFS proposed rule, we considered a number of other options for simplifying coding and payment for E/M services to align with the proposed reduction in documentation requirements and better account for the resources associated with inherent complexity, visit complexity, and visits furnished on the same day as a 0-day global procedure. For example, as we noted in the proposed rule, we considered establishing single payment rates for new and established patients for combined E/M visit levels 2 through 4, as opposed to combined E/M visit levels 2 through 5, as we proposed. We considered the potential impacts of making this change in isolation. TABLE 100—UNADJUSTED ESTIMATED SPECIALTY IMPACTS OF SINGLE PFS RATE FOR OFFICE/OUTPATIENT E/M LEVELS 2 THROUGH 4 [As displayed in the CY 2019 PFS proposed rule] Allowed charges (millions) Specialty Podiatry .................................................................................................................................................................... Dermatology ............................................................................................................................................................. Hand Surgery ........................................................................................................................................................... Oral/Maxillofacial Surgery ........................................................................................................................................ Otolaryngology ......................................................................................................................................................... Cardiology ................................................................................................................................................................ Hematology/Oncology .............................................................................................................................................. Neurology ................................................................................................................................................................. Rheumatology .......................................................................................................................................................... Endocrinology .......................................................................................................................................................... $2,022 3,525 202 57 1,220 6,723 1,813 1,565 559 482 Impact (percent) 10 6 5 4 4 ¥3 ¥3 ¥3 ¥6 ¥8 Note: All other specialty level impacts were within +/¥3%. amozie on DSK3GDR082PROD with RULES3 Table 100 shows the specialties that would experience the greatest increase or decrease by establishing single payment rates for E/M visit levels 2 through 4, while maintaining the value of the level 1 and the level 5 E/M visits. We note that this alternative is similar to the policy we are finalizing for CY 2021. However, we are also finalizing VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 the inherent visit complexity add-on codes that will likely result in mitigating some of the more significant estimated specialty-level impacts of establishing a single rate for the level 2– 4 visits. While considering whether to finalize a single payment rate for new and established office/outpatient E/M visit PO 00000 Frm 00226 Fmt 4701 Sfmt 4700 levels 2–5, we explored a number of alternative scenarios based on commenters’ varied responses to aspects of our proposal. For example, we considered the potential impacts on finalizing all elements of the proposal except for the MPPR and the single PE/ hr value across the office/outpatient E/ M code set. E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60061 amozie on DSK3GDR082PROD with RULES3 TABLE 101—SPECIALTY LEVEL IMPACTS OF FINALIZING AS PROPOSED WITH THE EXCEPTION OF THE MPPR AND PE/hr ADJUSTMENTS Specialty Allowed charges (mil) Impact of work RVU changes (%) Impact of PE RVU changes (%) Impact of MP RVU changes (%) Combined impact (%) (A) (B) (C) (D) (E) (F) Allergy/Immunology .............................................................. Anesthesiology ..................................................................... Audiologist ............................................................................ Cardiac Surgery ................................................................... Cardiology ............................................................................ Chiropractor ......................................................................... Clinical Psychologist ............................................................ Clinical Social Worker .......................................................... Colon And Rectal Surgery ................................................... Critical Care ......................................................................... Dermatology ......................................................................... Diagnostic Testing Facility ................................................... Emergency Medicine ........................................................... Endocrinology ...................................................................... Family Practice .................................................................... Gastroenterology .................................................................. General Practice .................................................................. General Surgery ................................................................... Geriatrics .............................................................................. Hand Surgery ....................................................................... Hematology/Oncology .......................................................... Independent Laboratory ....................................................... Infectious Disease ................................................................ Internal Medicine .................................................................. Interventional Pain Mgmt ..................................................... Interventional Radiology ...................................................... Multispecialty Clinic/Other Phys .......................................... Nephrology ........................................................................... Neurology ............................................................................. Neurosurgery ....................................................................... Nuclear Medicine ................................................................. Nurse Anes/Anes Asst ......................................................... Nurse Practitioner ................................................................ Obstetrics/Gynecology ......................................................... Ophthalmology ..................................................................... Optometry ............................................................................ Oral/Maxillofacial Surgery .................................................... Orthopedic Surgery .............................................................. Other .................................................................................... Otolarngology ....................................................................... Pathology ............................................................................. Pediatrics ............................................................................. Physical Medicine ................................................................ Physical/Occupational Therapy ........................................... Physician Assistant .............................................................. Plastic Surgery ..................................................................... Podiatry ................................................................................ Portable X-Ray Supplier ...................................................... Psychiatry ............................................................................. Pulmonary Disease .............................................................. Radiation Oncology And Radiation Therapy Centers ......... Radiology ............................................................................. Rheumatology ...................................................................... Thoracic Surgery .................................................................. Urology ................................................................................. Vascular Surgery ................................................................. $239 1,981 68 294 6,618 754 776 728 166 342 3,486 733 3,121 482 6,208 1,757 429 2,093 197 214 1,741 646 649 10,767 868 386 149 2,190 1,529 804 50 1,242 4,065 638 5,448 1,309 68 3,743 31 1,210 1,165 61 1,107 3,950 2,457 377 1,974 99 1,187 1,715 1,766 4,911 541 358 1,738 1,148 1 0 0 ¥1 0 0 0 ¥1 0 ¥1 3 0 ¥1 0 0 ¥1 0 0 ¥2 3 ¥1 0 ¥1 ¥1 2 0 ¥1 ¥2 ¥1 0 ¥1 ¥1 1 3 0 1 1 1 ¥1 4 0 ¥1 ¥1 0 1 1 0 0 0 ¥2 ¥1 0 0 ¥1 3 0 1 0 1 ¥1 ¥1 0 2 2 1 ¥1 4 ¥4 0 ¥1 0 0 0 0 ¥1 2 ¥1 4 ¥1 0 3 ¥1 ¥1 ¥1 ¥1 0 ¥1 0 1 3 ¥1 0 1 2 3 4 ¥1 0 0 ¥2 2 1 ¥3 0 1 ¥2 ¥1 ¥1 0 ¥1 3 ¥2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 ¥1 1 ¥2 ¥1 ¥1 1 2 2 ¥2 7 ¥5 ¥1 ¥1 0 ¥1 0 1 ¥4 5 ¥2 3 ¥2 ¥1 5 ¥1 ¥2 ¥3 ¥2 0 ¥2 ¥1 1 6 ¥1 1 2 3 3 8 ¥1 ¥1 ¥1 ¥2 3 3 ¥4 0 1 ¥4 ¥2 ¥1 0 ¥2 6 ¥1 Total .............................................................................. 92,771 0 0 0 0 We also explored an alternative of finalizing all elements of the proposal VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 except for separate coding for podiatric E/M visits and the application of a PO 00000 Frm 00227 Fmt 4701 Sfmt 4700 single PE/hr across the office/outpatient E/M codes. E:\FR\FM\23NOR3.SGM 23NOR3 60062 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations amozie on DSK3GDR082PROD with RULES3 TABLE 102—SPECIALTY LEVEL IMPACTS OF FINALIZING AS PROPOSED WITH THE EXCEPTION OF THE SEPARATE PODIATRIC G CODES AND PE/hr ADJUSTMENTS Specialty Allowed charges (mil) Impact of work RVU changes (%) Impact of PE RVU changes (%) Impact of MP RVU changes (%) Combined impact (%) (A) (B) (C) (D) (E) (F) Allergy/Immunology .............................................................. Anesthesiology ..................................................................... Audiologist ............................................................................ Cardiac Surgery ................................................................... Cardiology ............................................................................ Chiropractor ......................................................................... Clinical Psychologist ............................................................ Clinical Social Worker .......................................................... Colon And Rectal Surgery ................................................... Critical Care ......................................................................... Dermatology ......................................................................... Diagnostic Testing Facility ................................................... Emergency Medicine ........................................................... Endocrinology ...................................................................... Family Practice .................................................................... Gastroenterology .................................................................. General Practice .................................................................. General Surgery ................................................................... Geriatrics .............................................................................. Hand Surgery ....................................................................... Hematology/Oncology .......................................................... Independent Laboratory ....................................................... Infectious Disease ................................................................ Internal Medicine .................................................................. Interventional Pain Mgmt ..................................................... Interventional Radiology ...................................................... Multispecialty Clinic/Other Phys .......................................... Nephrology ........................................................................... Neurology ............................................................................. Neurosurgery ....................................................................... Nuclear Medicine ................................................................. Nurse Anes/Anes Asst ......................................................... Nurse Practitioner ................................................................ Obstetrics/Gynecology ......................................................... Ophthalmology ..................................................................... Optometry ............................................................................ Oral/Maxillofacial Surgery .................................................... Orthopedic Surgery .............................................................. Other .................................................................................... Otolarngology ....................................................................... Pathology ............................................................................. Pediatrics ............................................................................. Physical Medicine ................................................................ Physical/Occupational Therapy ........................................... Physician Assistant .............................................................. Plastic Surgery ..................................................................... Podiatry ................................................................................ Portable X-Ray Supplier ...................................................... Psychiatry ............................................................................. Pulmonary Disease .............................................................. Radiation Oncology And Radiation Therapy Centers ......... Radiology ............................................................................. Rheumatology ...................................................................... Thoracic Surgery .................................................................. Urology ................................................................................. Vascular Surgery ................................................................. $239 1,981 68 294 6,618 754 776 728 166 342 3,486 733 3,121 482 6,208 1,757 429 2,093 197 214 1,741 646 649 10,767 868 386 149 2,190 1,529 804 50 1,242 4,065 638 5,448 1,309 68 3,743 31 1,210 1,165 61 1,107 3,950 2,457 377 1,974 99 1,187 1,715 1,766 4,911 541 358 1,738 1,148 1 0 0 ¥1 0 0 0 0 0 ¥1 1 0 0 0 0 ¥1 0 0 ¥2 1 ¥1 0 ¥1 ¥1 2 1 ¥1 ¥1 ¥1 0 ¥1 0 0 3 0 1 1 1 ¥1 2 0 ¥1 ¥1 0 0 1 5 0 0 ¥2 0 0 ¥1 ¥1 2 0 1 0 2 ¥1 ¥1 1 2 2 0 ¥1 1 ¥4 0 ¥1 0 0 0 0 ¥1 1 ¥1 4 ¥1 0 2 ¥1 ¥1 ¥1 ¥1 0 ¥1 0 1 2 ¥1 0 1 1 4 2 ¥1 0 0 ¥1 1 1 5 0 1 ¥1 0 ¥1 ¥1 ¥1 3 ¥1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 0 1 ¥2 ¥1 0 1 2 0 ¥2 2 ¥4 ¥1 ¥1 0 ¥1 0 0 ¥3 2 ¥2 4 ¥2 ¥1 4 0 ¥2 ¥2 ¥2 0 ¥2 0 1 5 ¥1 1 2 1 3 4 ¥1 ¥1 ¥1 ¥1 1 2 10 1 1 ¥4 ¥1 0 ¥2 ¥2 5 ¥1 Total .............................................................................. 92,771 0 0 0 0 We considered alternatives that included finalizing all elements of the proposal, except for the PE/hr change and separate coding for podiatric E/M VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 visits and establishing a single payment rate for office/outpatient new and established E/M visit levels 2 through 4, rather than a single payment rate for PO 00000 Frm 00228 Fmt 4701 Sfmt 4700 office/outpatient E/M levels 2 through 5 as proposed. Table 103 illustrates the specialty level impacts of this alternative. E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60063 amozie on DSK3GDR082PROD with RULES3 TABLE 103—SPECIALTY LEVEL IMPACT OF FINALIZING SINGLE PFS RATES FOR OFFICE/OUTPATIENT E/M LEVELS 2 THROUGH 4 AND OTHER PROPOSED ELEMENTS WITH THE EXCEPTION OF PE/hr ADJUSTMENT AND THE G-CODES FOR PODIATRIC VISITS Specialty Allowed charges (mil) Impact of work RVU changes (%) Impact of PE RVU changes (%) Impact of MP RVU changes (%) Combined impact (%) (A) (B) (C) (D) (E) (F) Allergy/Immunology .............................................................. Anesthesiology ..................................................................... Audiologist ............................................................................ Cardiac Surgery ................................................................... Cardiology ............................................................................ Chiropractor ......................................................................... Clinical Psychologist ............................................................ Clinical Social Worker .......................................................... Colon And Rectal Surgery ................................................... Critical Care ......................................................................... Dermatology ......................................................................... Diagnostic Testing Facility ................................................... Emergency Medicine ........................................................... Endocrinology ...................................................................... Family Practice .................................................................... Gastroenterology .................................................................. General Practice .................................................................. General Surgery ................................................................... Geriatrics .............................................................................. Hand Surgery ....................................................................... Hematology/Oncology .......................................................... Independent Laboratory ....................................................... Infectious Disease ................................................................ Internal Medicine .................................................................. Interventional Pain Mgmt ..................................................... Interventional Radiology ...................................................... Multispecialty Clinic/Other Phys .......................................... Nephrology ........................................................................... Neurology ............................................................................. Neurosurgery ....................................................................... Nuclear Medicine ................................................................. Nurse Anes/Anes Asst ......................................................... Nurse Practitioner ................................................................ Obstetrics/Gynecology ......................................................... Ophthalmology ..................................................................... Optometry ............................................................................ Oral/Maxillofacial Surgery .................................................... Orthopedic Surgery .............................................................. Other .................................................................................... Otolarngology ....................................................................... Pathology ............................................................................. Pediatrics ............................................................................. Physical Medicine ................................................................ Physical/Occupational Therapy ........................................... Physician Assistant .............................................................. Plastic Surgery ..................................................................... Podiatry ................................................................................ Portable X-Ray Supplier ...................................................... Psychiatry ............................................................................. Pulmonary Disease .............................................................. Radiation Oncology And Radiation Therapy Centers ......... Radiology ............................................................................. Rheumatology ...................................................................... Thoracic Surgery .................................................................. Urology ................................................................................. Vascular Surgery ................................................................. $239 1,981 68 294 6,618 754 776 728 166 342 3,486 733 3,121 482 6,208 1,757 429 2,093 197 214 1,741 646 649 10,767 868 386 149 2,190 1,529 804 50 1,242 4,065 638 5,448 1,309 68 3,743 31 1,210 1,165 61 1,107 3,950 2,457 377 1,974 99 1,187 1,715 1,766 4,911 541 358 1,738 1,148 1 ¥1 ¥1 ¥1 0 ¥1 ¥1 ¥1 ¥1 ¥1 0 0 ¥1 0 1 ¥1 ¥1 0 0 0 1 0 ¥1 0 1 0 ¥1 ¥2 0 ¥1 ¥1 ¥1 2 2 ¥1 0 0 0 ¥1 1 ¥1 1 ¥1 ¥1 1 0 3 0 0 ¥2 0 0 ¥1 ¥1 1 0 1 0 1 ¥1 ¥1 0 1 2 0 ¥1 0 ¥4 0 ¥1 1 0 0 0 0 0 0 4 ¥1 0 2 ¥1 ¥1 ¥1 0 0 ¥1 0 1 2 ¥1 ¥1 1 0 4 1 ¥1 0 0 ¥1 1 0 4 1 1 ¥1 0 ¥1 ¥1 0 2 ¥1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 ¥1 1 ¥1 ¥1 ¥1 1 1 ¥1 ¥2 0 ¥4 ¥1 ¥1 2 ¥2 ¥1 0 ¥1 0 1 4 ¥2 1 3 ¥1 ¥2 ¥2 0 ¥1 ¥2 ¥1 3 4 ¥2 0 1 0 3 2 ¥2 1 ¥2 ¥2 2 1 8 1 1 ¥3 ¥1 ¥1 ¥2 ¥1 4 ¥1 Total .............................................................................. 92,771 0 0 0 0 In this scenario, specialties that furnish a large volume of standalone office/outpatient E/M visits in VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 conjunction with minor procedures see decreases in overall impacts, while specialties who tend to only bill E/M PO 00000 Frm 00229 Fmt 4701 Sfmt 4700 office/outpatient visits see minor increases and in many instances, the application of the MPPR adjustment is E:\FR\FM\23NOR3.SGM 23NOR3 60064 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations not enough to overcome the negative impacts of the single payment rate on specialties that bill a higher volume of level 4 visits relative to their overall allowed services. We also modeled the specialty level impacts associated with finalizing all elements of the proposal with the exception of the PE/hr adjustment and the MPPR, but establishing a single payment rate for office/outpatient new and established E/M visit levels 2–4, rather than a single payment rate for office/outpatient E/M levels 2–5 as proposed. Table 104 illustrates the specialty level impacts for this alternative. amozie on DSK3GDR082PROD with RULES3 TABLE 104—SPECIALTY LEVEL IMPACT OF FINALIZING SINGLE PFS RATES FOR OFFICE/OUTPATIENT E/M LEVELS 2 THROUGH 4 AND OTHER ELEMENTS AS PROPOSED Specialty Allowed charges (mil) Impact of work RVU changes (%) Impact of PE RVU changes (%) Impact of MP RVU changes (%) Combined impact (%) (A) (B) (C) (D) (E) (F) Allergy/Immunology .............................................................. Anesthesiology ..................................................................... Audiologist ............................................................................ Cardiac Surgery ................................................................... Cardiology ............................................................................ Chiropractor ......................................................................... Clinical Psychologist ............................................................ Clinical Social Worker .......................................................... Colon And Rectal Surgery ................................................... Critical Care ......................................................................... Dermatology ......................................................................... Diagnostic Testing Facility ................................................... Emergency Medicine ........................................................... Endocrinology ...................................................................... Family Practice .................................................................... Gastroenterology .................................................................. General Practice .................................................................. General Surgery ................................................................... Geriatrics .............................................................................. Hand Surgery ....................................................................... Hematology/Oncology .......................................................... Independent Laboratory ....................................................... Infectious Disease ................................................................ Internal Medicine .................................................................. Interventional Pain Mgmt ..................................................... Interventional Radiology ...................................................... Multispecialty Clinic/Other Phys .......................................... Nephrology ........................................................................... Neurology ............................................................................. Neurosurgery ....................................................................... Nuclear Medicine ................................................................. Nurse Anes/Anes Asst ......................................................... Nurse Practitioner ................................................................ Obstetrics/Gynecology ......................................................... Ophthalmology ..................................................................... Optometry ............................................................................ Oral/Maxillofacial Surgery .................................................... Orthopedic Surgery .............................................................. Other .................................................................................... Otolarngology ....................................................................... Pathology ............................................................................. Pediatrics ............................................................................. Physical Medicine ................................................................ Physical/Occupational Therapy ........................................... Physician Assistant .............................................................. Plastic Surgery ..................................................................... Podiatry ................................................................................ Portable X-Ray Supplier ...................................................... Psychiatry ............................................................................. Pulmonary Disease .............................................................. Radiation Oncology And Radiation Therapy Centers ......... Radiology ............................................................................. Rheumatology ...................................................................... Thoracic Surgery .................................................................. Urology ................................................................................. Vascular Surgery ................................................................. $239 1,981 68 294 6,618 754 776 728 166 342 3,486 733 3,121 482 6,208 1,757 429 2,093 197 214 1,741 646 649 10,767 868 386 149 2,190 1,529 804 50 1,242 4,065 638 5,448 1,309 68 3,743 31 1,210 1,165 61 1,107 3,950 2,457 377 1,974 99 1,187 1,715 1,766 4,911 541 358 1,738 1,148 0 ¥1 ¥1 ¥1 ¥1 ¥1 ¥1 ¥1 0 ¥2 2 0 ¥1 ¥1 1 ¥2 2 0 ¥1 1 0 ¥1 ¥1 0 1 0 ¥1 ¥1 0 ¥1 ¥1 ¥1 2 2 ¥1 0 1 0 ¥1 3 ¥1 1 ¥1 ¥1 2 0 ¥1 0 3 ¥1 0 ¥1 0 ¥1 2 0 0 0 1 ¥1 ¥1 ¥1 1 2 1 ¥1 3 ¥5 0 ¥1 1 0 1 0 0 2 0 3 0 0 2 ¥1 ¥1 0 0 0 ¥1 0 1 2 ¥1 ¥1 1 1 3 3 ¥1 0 0 ¥2 2 1 ¥4 0 2 ¥1 ¥1 ¥1 0 ¥1 3 ¥2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 ¥2 0 ¥2 ¥2 ¥2 0 1 1 ¥3 5 ¥5 ¥2 ¥1 3 ¥2 4 0 ¥1 3 0 3 ¥1 0 3 ¥1 ¥2 ¥1 ¥1 ¥1 ¥2 ¥2 3 5 ¥2 ¥1 1 1 2 6 ¥2 1 ¥2 ¥3 4 1 ¥5 0 5 ¥1 ¥1 ¥2 0 ¥2 5 ¥2 Total .............................................................................. 92,771 0 0 0 0 VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00230 Fmt 4701 Sfmt 4700 E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations amozie on DSK3GDR082PROD with RULES3 2. E/M Documentation Alternatives Considered We considered several alternatives to our final policies on documentation of E/M office/outpatient visits. Under all of these alternatives, we would finalize the documentation proposals that are not associated with coding and payment changes (the documentation proposals for home visits and avoiding redundant data recording that we are finalizing for January 1, 2019 as proposed). Regarding the rest of the documentation policies, one alternative we considered was to maintain all five current E/M office/outpatient visit levels and eliminate additional documentation requirements. Under this option, there would be no minimum documentation standard because payment rates for multiple code levels would not be combined, but we could still have allowed choice in documentation methodology (current framework, MDM or time). Overall payments would likely change due to increased ability to use different key components to reach different code levels relative to the status quo. There would be no new add-on codes for primary care, other non-procedural specialty care or prolonged services, since the current code set would continue to differentiate levels of complexity. We estimate that this alternative would have reduced the documentation burden for office/ outpatient visits by approximately 5 percent or 0.32 minutes per impacted visit. However, this alternative could result in significant and unpredictable redistributive effects as there would be a financial incentive to code to the highest possible visit level. Given that possibility, we chose not to finalize this alternative. Another alternative was our proposed policies, which in the proposed rule we estimated would have reduced administrative burden by approximately 1.6 minutes per impacted visit. A large part of this time savings was attributed to the associated application of the minimum level 2 visit documentation standard to most visits (levels 2 through 5). We did not finalize this proposal because we were persuaded by public comments (detailed elsewhere in this final rule), indicating that Medicare should continue to recognize distinctions in visit complexity among the current level 2 through 5 visits. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 3. Modernizing Medicare Physician Payment by Recognizing Communication Technology-Based Services Alternatives Considered We considered not finalizing our proposal in the CY 2019 PFS proposed rule to recognize a discrete set of services that are defined by and inherently involve the use of communication technology. If we had not finalized making separate coding and payment for HCPCS codes G2010 ((Remote evaluation of recorded video and/or images submitted by an established patient (e.g., store and forward), including interpretation with follow-up with the patient within 24 business hours, not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment) and G2012 ((Brief communication technology-based service, e.g. virtual check-in, by a physician or other qualified health care professional who can report evaluation and management services, provided to an established patient, not originating from a related E/ M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment; 5–10 minutes of medical discussion) for CY 2019, we estimate that there would have been a 0.2 percent increase to the CF, based on our estimate that usage of these services will result in fewer than 1 million visits in the first year but will eventually result in more than 19 million visits per year, ultimately increasing payments under the PFS by about 0.2 percent. 4. Alternatives Considered for the AUC Program For the purposes of estimating potential alternatives to the proposals in the CY 2019 PFS proposed rule for the AUC program, we considered the alternative scenarios below. a. Consultation With More Than One Qualified CDSM We considered an alternative scenario that would result in ordering professionals or auxiliary staff consulting more than one qualified CDSM prior to ordering advanced diagnostic imaging. In this scenario, we assumed a goal of decreasing the frequency that a ‘‘not applicable’’ consultation result would be reported on Medicare claims. One outcome of reducing ‘‘not applicable’’ responses is the potential to improve the quality and quantity of claims-based data available for calculating outlier ordering PO 00000 Frm 00231 Fmt 4701 Sfmt 4700 60065 professionals. In future rulemaking the agency will establish the methodology to identifying outlier ordering professionals. Reducing ‘‘not applicable’’ responses will increase responses for adherence or nonadherence thereby increasing the total number of responses that can be used to calculate outlier ordering professionals. Additionally, according to the Medicare Imaging Demonstration Evaluation Report,1 clinicians were conceptually interested in learning about how to improve ordering patterns. Ordering professionals receiving ‘‘not applicable’’ responses for some of their orders may not be able to achieve desired learning directly through the CDSM and may have to seek information elsewhere. Therefore reducing the number of ‘‘not applicable’’ responses may allow ordering professionals to achieve more of their learning within the CDSM. In this assumption, the ordering professional or auxiliary personnel would consult their primary, qualified CDSM to find that such AUC were not available. For example, a consultation using CDSM 1 for a patient with unspecified abdominal pain results in no specified applicable AUC being available, and therefore, provides a ‘‘not applicable’’ result. In this clinical scenario, we know that specified applicable AUC are available (https:// acsearch.acr.org/docs/69467/Narrative/) in qualified CDSM 2 and that CDSM 2 is available free of charge. Second, we assumed that additional requirements to reduce ‘‘not applicable’’ consultation outcomes, through tighter stipulations on AUC consultation, would change behavior in that a second consultation would occur (qualified CDSM 2). For example, we know that all CDSMs are required, consistent with § 414.94(g)(1)(iii) of our regulations to make available, at a minimum, specified applicable AUC that reasonably address common and important clinical scenarios within all priority clinical areas. Therefore, there may be clinical scenarios (for example, unspecified abdominal pain) outside of priority clinical areas that are not addressed within all qualified CDSMs. However, tighter requirements on AUC consultation—to consult a second CDSM when a ‘‘not applicable’’ response is the result of the first consultation in specific clinical scenarios—would reduce ‘‘not applicable’’ reporting on Medicare claims and would motivate ordering professionals to access a secondary CDSM that is qualified and available free of charge. CMS did not propose to require any ordering professional to E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 60066 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations perform any additional AUC consultation if the initial consultation yields a result of ‘‘not applicable.’’ Rather, the ordering professional would have completely satisfied their AUC consultation requirement under § 414.94(j) with the first AUC consultation, regardless of the determination of the qualified CDSM. Based on these assumptions, we identified examples of the advanced diagnostic imaging services that are outside the priority clinical areas yet have AUC available for a specific clinical scenario in a qualified, free CDSM. We focused our analysis on abdominal pain (any locations and flank pain). In addition, we identified the top five advanced diagnostic imaging services from data derived from the CCW’s 2014 Part B non-institutional claim line file, which includes services covered by the Part B benefit that were furnished during calendar year 2014. These data are available at https:// www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Appropriate-Use-CriteriaProgram/data.html. We estimated the burden of consulting a second, free CDSM to reduce the frequency of ‘‘not applicable’’ responses, which we did not propose. We did this by calculating the number of advanced diagnostic imaging services for unspecified abdominal pain based on 2014 claims data (Computed tomography of abdomen & pelvis with contrast—CPT 74177—299,644 services; Computed tomography of abdomen & pelvis with and without contrast—CPT 74176— 233,088 services; Computed tomography of abdomen and pelvis; without contrast material in one or both body regions, followed by contrast material(s) and further sections in one or both body regions—CPT 74178—36,992 services; Diagnostic nuclear medicine procedures on the gastrointestinal system with pharmacologic intervention—CPT 78227—20,997 services; Diagnostic nuclear medicine procedures on the gastrointestinal system—CPT 78226– 10,713 services). According to the Medicare Imaging Demonstration Evaluation Report,1 clinicians were conceptually interested in learning about how to improve ordering patterns, and in the context of clinical practice, most clinician focus group participants noted that they expected that a clinical decision support tool would provide more detailed feedback that would help clinicians reduce the number of inappropriately rated orders. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 Unfortunately, data compiled 73 as of 2002 suggested that appropriateness criteria could not be applied to 41percent of MRI imaging requests. These gaps in appropriateness criteria often prompt local providers to augment the criteria produced by professional societies with their own decisions on appropriateness. One study 74 has shown that clinicians use appropriateness criteria far less often than other resources, such as specialist consults and UpToDate (Wolters Kluwer Health), to guide the management of their patients. In order to meet the expressed needs of ordering professionals, and direct ordering behaviors towards qualified CDSMs with specific applicable AUC, we considered pursuing tighter requirements in the context of the following impact estimate. If we assume that 50 percent of these 601,434 total services required a second consultation because the specified applicable AUC were available in CDSM 1 then this estimate would be the time and effort for a 2-minute repeat consultation with another qualified CDSM available free of charge for 300,717 services annually (601,434 services × 50 percent). If 90 percent of those consultations (300,717 services × 90 percent × 0.033 hr/service) for 8,931.285 total hours were performed by a medical assistant (occupation code 31–9092) at a rate of $32.30/hour for a total of $288,480.50 and 10 percent of consultations (300,717 services × 10 percent × 0.033 hr/service) for 992.376 total hours were performed by the ordering professional at a rate of $200.54/hour for a total of $199,011.08 then annually the burden estimate would be 9,923.661 total hours (8,931.285 hours + 992.376 hours) and $487,491.58 ($288,480.50 + $199,011.08) to perform the second consultations. This analysis was limited to abdominal pain because that is one example of a clinical scenario that falls outside of the priority clinical areas. In the proposed rule we did not propose tighter requirements on the frequency to which ordering professionals or applicable staff would be required to consult at this time this was due to the agency’s efforts to minimize burden whereas a second consultation would 73 Levy, G et al. 2006. Nonradiologist utilization of American College of Radiology appropriateness criteria in apreauthorization center for MRI requests: Applicability and effects. AJR Am J Roentgenol, 187(4), 855–858. doi: 10.2214/ AJR.05.1055. 74 Bautista, AB et al. 2009. Do clinicians use the American College of Radiology appropriateness criteria in the management of their patients? AJR Am J Roentgenol, 192(6), 1581–1585. doi: 10.2214/ AJR.08.1622. PO 00000 Frm 00232 Fmt 4701 Sfmt 4700 result in added time and cost to the ordering professional. b. Significant Hardship Application Process To illustrate the consideration that a self-attestation of a significant hardship exception is a less burdensome approach, we compared this to the alternative consideration of requiring a significant hardship exception application process to review and approve applicants in near real-time. We recognize that there are some benefits to a significant hardship exception application that could not be directly quantified. For instance, some ordering professionals may gain confidence knowing that they have documentation confirming that a significant hardship exception application was submitted and/or received by CMS. Those same ordering professionals and others may appreciate a process that includes receipt of a determination from CMS as to the acceptance of their application for significant hardship exception. Finally some furnishing professionals and facilities that provide advanced diagnostic imaging services as a result of orders placed by ordering professionals could have reassurance knowing that such ordering professionals have a significant hardship exception granted by CMS and confirmed for 1 year. As a basis for comparison of the significant hardship exception application to self-attestation, we estimate that such an application would be similar to the existing application (CMS–10621, OCN 0938–1314) to request a reweighting to zero for the advancing care information performance category (renamed the promoting interoperability performance category) due to significant hardship. This is a short online form that requires identifying which type of hardship applies, and a description of how the circumstances impair the ability to submit advancing care information data, as well as some proof of circumstances. The estimate for the $44.59 mean hourly wage and 100-percent fringe benefits of a computer system analyst (BLS #15– 1121) to submit this application is 0.5 hours. Given that we would expect 6,699 AUC hardship applications per year, the annual total burden hours are estimated to be 3349.50 hours (6,699 respondents × 0.5 burden hours per respondent). The estimated total annual burden is $298,708.41 (3349.50 hours × $89.18 per hour). Based in part on the cost and burden estimates, we did not propose the use of a significant hardship exception application. E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations amozie on DSK3GDR082PROD with RULES3 5. Alternatives Considered for the Quality Payment Program For purposes of the payment impact on the Quality Payment Program, we view the performance threshold and the additional performance threshold, as the critical factors affecting the distribution of payment adjustments. We ran two separate models with performance thresholds of 25 and 35 respectively (as an alternative to the finalized performance threshold of 30) to estimate the impact of a moderate and aggressive increase in the performance threshold. A lower performance threshold would be a more gradual transition and could potentially allow more clinicians to meet or exceed the performance threshold. The lower performance threshold would lower the amount of budget neutral dollars to redistribute and increase the number of clinicians with a positive payment adjustment but the scaling factor would be lower. In contrast, a more aggressive increase would likely lead to higher positive payment adjustments for clinicians that exceed the performance threshold because the budget neutral pool would be redistributed among fewer clinicians. We ran each of these models using the finalized additional performance threshold of 75. In the model with a performance threshold of 25, we estimate that $271 million would be redistributed through budget neutrality. There would be a maximum payment adjustment of 4.5 percent after considering the MIPS payment adjustment and the additional MIPS payment adjustment for exceptional performance. In addition, 7.2 percent of MIPS eligible clinicians would receive a negative payment adjustment among those that submit data. In the model with a performance threshold of 35, we estimate that $349 million would be redistributed through budget neutrality, and that there would be a maximum payment adjustment of 4.9 percent after considering the MIPS payment adjustment and the additional MIPS payment adjustment for exceptional performance. In addition, 10.5 percent of MIPS eligible clinicians would receive a negative payment adjustment among those that submit data. We finalized a performance threshold of 30 because we believe increasing the performance threshold to 30 points was not unreasonable or too steep, but rather a moderate step that encourages clinicians to gain experience with all MIPS performance categories. We refer readers to section III.I.3.j.(2) of this final rule for additional rationale on the selection of performance threshold. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 To evaluate the impact of modifying the additional performance threshold, we ran two models with additional performance thresholds of 70 and 80 as an alternative to the finalized 75 points. We ran each of these models using a performance threshold of 30. The benefit of the model with the additional performance threshold of 70 would maintain the additional performance threshold that was in years 2 and 3. In the model with the additional performance threshold of 70, we estimate that $310 million would be redistributed through budget neutrality, and there would be a maximum payment adjustment of 3.9 percent after considering the MIPS payment adjustment and the additional MIPS payment adjustment for exceptional performance. In addition, 8.8 percent of MIPS eligible clinicians would receive a negative payment adjustment among those that submit data. In the model with an additional performance threshold of 80, for which the benefit was to assess the impact of the proposed additional performance threshold in the 2019 PFS proposed rule, we estimate that $310 million would be redistributed through budget neutrality, and that there would be a maximum payment adjustment of 6.1 percent after considering the MIPS payment adjustment and the additional MIPS payment adjustment for exceptional performance among those that submit data. Also, that 8.8 percent of MIPS eligible clinicians will receive a negative payment adjustment. We finalized the additional performance threshold at 75 points, which is halfway between our proposal of 80 and the CY 2018 MIPS performance period additional performance threshold at 70 because we believe raising the additional performance threshold, but for less than the original amount proposed, would incentivize continued improved performance while accounting for policy changes in the third year of the program. We refer readers to section III.I.3.j.(3) of this final rule for additional rationale on the selection of additional performance threshold. To examine the impact of changes to the low-volume threshold on the number of MIPS eligible clinicians, we ran estimates for three different lowvolume threshold criteria. As we discuss in section III.I.3.c of this final rule, we analyzed the impact of alternate low-volume thresholds because the low-volume threshold can affect the number of MIPS eligible clinicians and some public commenters were concerned about the associated PO 00000 Frm 00233 Fmt 4701 Sfmt 4700 60067 impacts of the exclusions on the MIPS payment adjustments. When we set the third low volume threshold at 100 as an alternative to 200 covered professional services, we estimate that 32,828 clinicians would elect to opt-in for a total population of 802,915. When we apply the opt-in policy without adding the third finalized low-volume criterion at 200 covered professional services, we estimate that 12,242 clinicians would elect to opt-in for a total population of 782,329. When we lower the lowvolume threshold criteria to $30,000 or fewer allowed charges for covered professional services; 100 or fewer Part B-enrolled individuals; and 100 or fewer furnished covered professional services to Medicare Part B-enrolled beneficiaries, we estimate a total of 871,238 MIPS eligible clinicians. To assess the impact of the number of MIPS eligible clinicians on payment adjustments, we ran a model with the lowest low-volume threshold and, therefore, highest number of MIPS eligible clinicians (871,238). We estimate that $440 million would be redistributed through budget neutrality. There would be a maximum payment adjustment of 5.0 percent after considering the MIPS payment adjustment and the additional MIPS payment adjustment for exceptional performance. In addition, 9.7 percent of MIPS eligible clinicians would receive a negative payment adjustment among those that submit data. These alternative low-volume thresholds were not selected because we did not observe a meaningful difference on the maximum payment adjustment from the finalized low-volume threshold in this final rule. As we stated in section III.I.3.c.(4) of this final rule, we will continue to strike a balance between ensuring sufficient participation in MIPS while also addressing the needs of small practices that may find it difficult to meet the program requirements. We refer readers to section III.I.3.c.(4) of this final rule for additional rationale on the selection of the low-volume threshold. H. Impact on Beneficiaries There are a number of changes in this final rule that will have an effect on beneficiaries. In general, we believe that many of these changes, including those intended to improve accuracy in payment through regular updates to the inputs used to calculate payments under the PFS, will have a positive impact and improve the quality and value of care provided to Medicare providers and beneficiaries. E:\FR\FM\23NOR3.SGM 23NOR3 60068 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 1. Evaluation and Management Documentation All health care practitioners, as part of their routine record keeping activities, create and maintain documentation in the patient medical record for clinical and payment purposes. It is standard industry practice that when healthcare practitioners bill insurers, payers and health plans, such as Medicare, state plans under Title XIX, and commercial or other third party payers, for office and outpatient E/M services, that health care practitioners report the services using the common coding framework and definitions developed and maintained by the AMA CPT Editorial Panel. The 1995/1997 E/M services documentation guidelines provide guidance to medical practitioners regarding medical record documentation of E/M services based on the AMA CPT coding framework and definitions. In response to comments received from RFIs released to the public under our Patients Over Paperwork Initiative, we proposed to address medical documentation by simplifying the payment framework for E/M services and allowing greater flexibility on the components practitioners could choose to document when billing Medicare for E/M visits. We estimate that the E/M visit documentation changes finalized in section II.I. of this final rule may significantly reduce the amount of time practitioners spend documenting office/ outpatient E/M visits. Although little research is available on exactly how much time physicians and nonphysician practitioners (NPPs) spend specifically documenting E/M visits, according to one recent estimate, primary care physicians spend on average, 84 minutes or 1.4 hours per day (24 percent of the time that they spend working within an EHR) documenting progress notes.75 Another study found that primary care physicians spend an average of 2.1 hours per day writing progress notes (both in-clinic and remote access).76 Assuming an average of 20 patient visits per day, one E/M visit per patient, and using the higher figure of 2.1 hours per day spent documenting these visits, in our proposed rule we estimated that documentation of an average outpatient/ office E/M visit takes 6.3 minutes.77 We stated our belief that our proposals to reduce redundancy in visit documentation, to allow auxiliary staff and the beneficiary to enter certain information in the medical record that would be verified but not required to be re-documented by the billing practitioner, to allow the choice of visit level and documentation based on MDM or time as alternatives to the current framework, and to require only minimum documentation (the amount required for a level 2 visit) for all visits except level 1 visits may reduce the documentation time by one quarter of the current time for the average office/ outpatient visit. Under this assumption, we estimated these proposals would save clinicians approximately 1.6 minutes of time per office/outpatient E/ M visit billed to Medicare. For a fulltime practitioner whose panel of patients is 40 percent Medicare (60 percent other payers), this would translate to approximately 51 hours saved per year.78 We noted that stakeholders had emphasized to us in public comments that whatever reductions may be made to the E/M documentation guidelines for purposes of Medicare payment, physicians and non-physician practitioners will still need to document substantial information in their progress notes for clinical, legal, operational, quality reporting and other purposes, as well as potentially for other payers. Furthermore, we recognized that there may be a ramp-up period for physicians and non-physician practitioners to implement the proposed documentation changes in their clinical workflow and EHR such that the effects of mitigating documentation burden may not be immediately realized. Accordingly, we believed the total amount of time practitioners spend on E/M visit documentation may remain high, despite the time savings that we estimated in our proposed rule could result from our E/M documentation proposals. These and all other improvements to payment accuracy that we proposed for CY 2019 were described in greater detail in section II.I. of the proposed rule. We welcomed public comments on our assumptions for the estimated reduction in 75 Arndt BG, Beasley JW, Watkinson MD, et al. Tethered to the EHR: Primary care physician workload assessment using EHR event log data and time-motion observations. Ann Fam Med. 2017;15:427–33. 76 Tai-Seale M, Olson CW, Li J, et al. Electronic health record logs indicate that physicians split time evenly between seeing patients and desktop medicine. Health Aff (Milwood). 2017;36:655–62. 77 20 patient visits per day based on the average number reported in the Physicians Foundation 2016 Survey of America’s Physicians, available online at https://physiciansfoundation.org/wp-content/ uploads/2018/01/Biennial_Physician_Survey_ 2016.pdf. 78 Forty percent of 20 total patients per day = 8 Medicare vists per day. (8 visits per day)*(1.6 minutes per visit)*(240 days per year) = 51.2 hours. amozie on DSK3GDR082PROD with RULES3 I. Burden Reduction Estimates VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00234 Fmt 4701 Sfmt 4700 documentation burden related to our E/ M visit proposals. Comment: We received many public comments on our assumptions regarding the potential burden reduction associated with our E/M proposals. The commenters stated that CMS overestimated how much the proposals would reduce burden, and noted they would reduce burden less than CMS estimated or, according to some commenters, might increase burden overall. Some commenters stated that the time and labor saved on documentation would be time currently spent after hours and on weekends, so it would not translate into additional ‘‘work time’’ or availability to see more patients. They stated that documentation time, in general, would remain high, due to the need to continue documenting for clinical, legal and many other purposes such as risk adjustment, quality reporting and other payers. Many of the commenters stated concerns that other payers including Medicaid and secondary payers might not adopt the same policies as Medicare, and that incongruities in documentation rules between payers would necessitate extra effort by practices to assess the best or required documentation method, among so many choices, for different patients. They noted that which payer(s) a given patient has is not always known at the outset of the visit. Many commenters stated there would be significant burden and cost to update EHRs and educate and train coders, staff and auditors. Also, they noted that without appropriate medical documentation for each visit, the proposals might result in insufficient documentation by one member of the care team that another member might have to make up for, and that fractured care from incomplete or insufficient documentation might inadvertently create additional burdens, as well as impact quality of care. While many commenters supported allowing a choice in documentation methodology (current framework, medical decisionmaking, or time), other commenters noted such a policy would increase burden due to increased variation in how visits would be documented, and the need to restructure EHR templates to accommodate different options and decide which method was best for a given patient or practice. Most of the commenters noted our proposals regarding billing eligibility and supporting documentation for the proposed add-on codes for primary care, other specialty care, prolonged services, and documenting using time were unclear and might create new burdens that would equal or exceed the current E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations burden. Some commenters stated that our proposals layered on complexity that would counteract the goal of reducing administrative burden, and that the negative impacts of the payment proposals would outweigh positive impacts of documentation changes. Other commenters were concerned about impacts on MA plan payments, plan quality, and provider access. Some commenters were concerned that paying for visits based on a single rate would not allow an understanding of the complexity of care being delivered and might lead to abuse. Another commenter noted that the proposed add-on codes to account for care complexity would increase complexity and result in a need for perpetual fixes from unanticipated consequences. Similar to other commenters, this commenter was concerned that a single payment rate would redistribute payments without reducing the burden associated with determining the right codes, because the coding structure would remain the same. The commenter also expressed concern that practitioners would be less willing to see complex patients, and that the proposal would incentivize gaming by certain specialties to make up for lost revenue. The commenter’s preferred approach was to simplify the current guidelines and rather than implement a single payment rate, CMS should wait for the AMA/CPT’s E/M workgroup results. Finally, the commenter recommended that if CMS finalized as proposed, CMS should phase implementation and create a monitoring process. Response: We understand that practitioners would continue to need to document substantial information in the medical record for clinical, legal and many other purposes such as risk adjustment, quality reporting, productivity measures and potentially other payers. In making our proposal, we did not aim to eliminate the need to document any history, exam, and/or MDM, but rather, we ocused on eliminating unnecessary, and outdated requirements that are associated with payment for visit ‘‘levels.’’ This would allow the practitioner to document what is clinically relevant and needed to support the service within whatever framework they chose to apply—along with medical necessity—rather than outdated aspects of the current guidelines. We understand that other payers might not adopt the same approach, at least not in the short term. The AMA/CPT has stated an intention to revise the E/M code set by 2020 or 2021, which would help to establish uniformity among payers. However, we agree with the commenters that it would be critical to allow time for education, changing workflows and billing 60069 systems. We understand that particularly in the initial year(s) of any changes, there would be a cost to these activities for practitioners and providers, including a cost to update EHRs. We are reducing our estimate of burden reduction to account for these issues. We note that we believe that time physicians spend fulfilling current documentation requirements on evenings and weekends are burdensome, and that even if that additional time would not necessarily be spent seeing additional patients, that time is a quantifiable resource cost to physicians and other practitioners. After considering the comments, we adjusted our proposed burden reduction estimate, including our estimates on the documentation of an average outpatient/ office E/M. We are still assuming an average of 20 patient visits per day, one E/M visit per patient, but instead are using the more conservative figure of 1.4 hours per day spent documenting E/M visits that we identified in our review of available research. As a result, we estimate that documentation of an average outpatient/office E/M visit takes 4.2 minutes versus our initial estimate of 6.3 minutes. The final rule estimated time savings is monetized into practitioner wages and summarized as follows. TABLE 105—ESTIMATED BURDEN REDUCTION FOR E/M DOCUMENTATION FINAL POLICIES amozie on DSK3GDR082PROD with RULES3 [Practitioner wages] 2019 2020 2021 2022 2023 and annually thereafter Grand Total ...................................................... $84,059,794.68 $84,059,794.68 $298,522,913.92 $405,754,473.54 $512,986,033.15 We calculated the time savings associated with documentation changes annually, and converted this time to practitioner wages using 2016 hourly wage data from the Bureau of Labor Statistics (BLS) 79 multiplied by two to adjust for overhead and benefits. We adjusted for the estimated proportion of impacted visits furnished by NPPs earning lower wages than physicians, which we acknowledge is unclear due to the ability to report services as ‘‘incident to’’ a physician when they are furnished directly by an NPP. We approximated the portion attributable to NPP wages using the number of visits directly reported by NPPs (reported with a specialty of NP, PA, CNS or CNM). The estimated savings for 2019 and 2020 are for the initial changes to documentation in these years (those not impacted by coding and payment changes, including provisions to no longer require documentation of the medical necessity of a home visit in lieu of an office visit and to expand current policy reducing the need to redocument prior data in the medical record). These savings would impact levels 2 through 5 visits, and are estimated to save 0.11 minutes 80 per impacted visit, which translates into approximately $84 million in wages across all impacted visits. Additional savings are estimated annually starting in 2021 for the 79 https://www.bls.gov/oes/2016/may/oes_ nat.htm. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 80 2.5% of the 4.2 minutes we estimate that it currently takes to document an office/outpatient E/M visit. PO 00000 Frm 00235 Fmt 4701 Sfmt 4700 finalized payment and coding-related changes. These savings would impact levels 3 and 4 visits, and are estimated to save 0.63 minutes 81 per impacted visit, which translates into approximately $513 million annually in wages across all impacted visits. We assume half of these estimated savings in year 1 (2021), 75 percent in year 2 (2022) and 100 percent each subsequent year (2023 and each year thereafter) to account for information provided in the public comments that there is 81 We reduced the final rule time savings estimate of 25% (1.1 minutes) to 15 percent (0.63 minutes). We reduced it by 10 percentage points to account for the burden of documenting level 5 visits, as well as the level 2–4 combined visit. This is to account for the uncertainty of the future code structure/ definitions, as well as public comments that introducing variation in documentation choices and methods and providing for a bare bones minimum standard could increase burden). E:\FR\FM\23NOR3.SGM 23NOR3 60070 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations amozie on DSK3GDR082PROD with RULES3 potentially off-setting burden associated with the continued need to document for MA and potentially other payers, quality reporting, and clinical, legal and other purposes, as well as ramp-up costs to update EHRs and conduct training and education. The estimate assumes very minimal burden associated with use and documentation of the add-on codes for primary care and other specialty care, as well as the extended visit add-on code and otherwise documenting using time, as we are clarifying these policies and establishing minimal documentation rules discussed in section II.I. of this final rule. We intend to allow flexibility in how office/outpatient visits are documented and to allow a choice in using the current framework, medical decision-making or time, though we will take into consideration any changes in the code set that may impact these options in future years. 2. Modernizing Medicare Physician Payment by Recognizing Communication Technology-Based Services As noted in section II.D. of this final rule, for CY 2019, we aimed to increase access for Medicare beneficiaries to physicians’ services that are routinely furnished via communication technology by clearly recognizing a discrete set of services that are defined by and inherently involve the use of communication technology. Accordingly, we made several proposals for modernizing Medicare physician payment for communication technology-based services. The use of communication technology-based services will provide new options for physicians to treat patients. These services could help to avoid unnecessary office visits, could consist of services that are already occurring but are not being separately paid, or could constitute new services. Medicare would pay $14 per visit in the first year for these communication technology-based services, compared with $92 per visit for the corresponding established patient visits. Practitioners have a choice of when to use the communication technologybased services. Because of the low payment rate relative to that for an office visit, we are assuming that usage of these services will be relatively low. In addition, we expect that the number of new or newly billable visits and subsequent treatments will outweigh the number of times that communication technology-based services will be used instead of more costly services. As a result, we expect that the financial impact of paying for the communication VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 technology-based services will be an increase in Medicare costs. We estimate that usage of these services will result in fewer than 1 million visits in the first year but will eventually result in more than 19 million visits per year, ultimately increasing payments under the PFS by about 0.2 percent. In order to maintain budget neutrality in setting proposed rates for CY 2019, we assumed the number of services that would result in a 0.2 percent reduction in the CF. As with all estimates, and particularly those for new separately billable services, this outcome is highly uncertain. Because recognition of communication technology-based services is a new area for healthcare coverage, the available information on which to base estimates is limited and is usually not directly applicable, particularly to a new Medicare payment. The cost and utilization estimates are based on Medicare claims data together with a study published in Health Affairs,82 which examined the cost and utilization of telehealth in the private sector. While this study was the most applicable for an estimate, we note that the results from this program may be different because Medicare experience may differ from private sector behavior and because the study was limited to acute respiratory infection visits. We also note that the study cites the use of direct-to-consumer telehealth companies, many of which provide access to care 24 hours per day, 7 days per week, 365 days per year, whereas the services described by HCPCS codes G2010 and G2012 are limited to only established patients. We proposed to make separate payment for these services when furnished by RHCs and FQHCs. A potential estimate of utilization and overall cost of these services by RHCs and FQHCs could be derived by comparing their use of chronic care management and other care management services to the same services furnished by practitioners paid under the PFS, since these care management services are also separately billable and do not take place in-person. Based on this comparison, and without considering potential variables and issues specific to these services, the impact the finalized policy would be less than $1 million in additional Medicare spending in the first year and could eventually result in up to $20 million in spending per year in future years. These estimates are uncertain and could change after further consideration 82 Ashwood, J.S. (2017 March) Direct-ToConsumer Telehealth May Increase Access To Care But Does Not Decrease Spending. Health Affairs. PO 00000 Frm 00236 Fmt 4701 Sfmt 4700 of the potential variables and issues specific to these services. 3. Outpatient Therapy Services As noted in section II.M. of this final rule, we are finalizing our proposal to end functional reporting for outpatient therapy services as part of our burden reduction efforts in response to the RFI on CMS Flexibilities and Efficiencies that was issued in the CY 2018 PFS proposed rule (82 FR 34172 through 34173). Under our functional reporting system therapy practitioners and providers are required to report, whenever functional reporting is required, non-payable HCPCS G-codes and modifiers—typically in pairs—to convey information about the beneficiary’s functional limitation category and functional status throughout the PT, OT, or SLP episode of care. In addition, each time functional reporting is required on the claim, the therapy provider must also document the functional reporting Gcodes and their modifiers in the medical record. In this final rule, we are finalizing our proposal to eliminate this requirement that therapy practitioners and providers report HCPCS G-codes and modifiers or document in the medical record to convey functional reporting status for PT, OT or SLP episode of care. To quantify the amount of burden reduction, we estimated the total amount of time that therapy practitioners spend doing functional reporting. To do this, we first looked at our data for CY 2017 for professional claims by the type of plan of care reported primarily by therapists in private practice (TPPs), including physical therapists, occupational therapists, and speech-language pathologists. We found that the overall utilization of the 42 functional reporting HCPCS G-codes totaled 15,456,421 single units, or 7,728,211 pairs. We then considered the time, on average, it might take to report on the claim and document in the medical record each pair of HCPCS G-codes. We noted this includes the time it takes to make the initial determination of the HCPCS G-code functional limitation category, as well as the time needed to make each initial and/or subsequent assignments for the applicable severity modifiers in order to define the patient’s functional status. We then made the assumption that it would take between 1 minute and 1.5 minutes, on average, to report the HCPCS G-code and modifier pair each time functional reporting is required. Using the total utilization of G-code pairs and the range of 1 minute to 1.5 minutes, we E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations amozie on DSK3GDR082PROD with RULES3 calculated that TPPs would have saved between 128,804 and 193,206 hours (or 7,728,211 to 11,592,317 minutes) collectively in CY 2017 if the functional reporting requirements had not been in place. We continue to believe this is a reasonable projection for the potential savings to TPPs, physicians and certain nonphysician practitioners in future years with the finalization of our proposal to end functional reporting effective January 1, 2019. Because therapy services are also furnished by providers of outpatient therapy services such as hospitals, SNFs and rehabilitation agencies that submit institutional claims, typically representing a greater amount of expenditures than practitioners submitting professional claims, we calculated additional savings for these providers using the same time assumptions of 1 to 1.5 minutes to report the HCPCS G-code and modifier pair each time functional reporting is required. Our 2017 data showed a total utilization of the functional reporting HCPCS G-codes is 29,053,921 single units, or 14,526,961 pairs, indicating that therapy providers would collectively save between 242,116 to 363,174 hours (or 14,526,961 to 21,790,442 minutes) for CY 2017 if the functional reporting requirements had not been effective during that year. As discussed in section II.M. of this final rule, we received many comments on our burden reduction proposal to eliminate our functional reporting requirements, and nearly all comments were supportive. We believe it is reasonable to estimate that in CY 2019 TPPs and other practitioners submitting professional claims and therapists working for providers submitting institutional claims will collectively save, at a minimum, the same number of collective hours we calculated they would save for CY 2017, as specified previously in this RIA, with dates of service on and after January 1, 2019. 4. Physician Supervision of Diagnostic Imaging Procedures We believe that the changes to the physician supervision requirements for RAs furnishing diagnostic imaging procedures as described in section II.F. of this final rule will significantly reduce burden for physicians. While approximately 215,000 diagnostic imaging services per year are currently performed that require personal supervision, we are not able to determine the number of these services that are performed by an RA due to limitations in the claims data. As a result, we are not able to quantify the amount of time potentially saved by VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 physicians and practitioners under the policy we are finalizing to require direct supervision of diagnostic imaging procedures done by RAs in cases where personal supervision would ordinarily be required. That said, stakeholders representing the practitioner community have indicated that changing the required supervision level for RAs will result in a redistribution of workload from radiologists to RAs, potentially resulting in improved practice efficiency and patient satisfaction. Stakeholders have stated that practitioners that utilize RAs have experienced improvements in practice efficiency, as use of RAs allows radiologists more time for professional services such as interpretation of images, and these practitioners cite greater flexibility that results in reduced wait times. Furthermore, stakeholders contend that the Medicare supervision requirements currently create disincentives to use RAs, as practitioners cannot make full use of them for Medicare patients, and the change to the supervision requirement would allow RAs to be more fully utilized. For these reasons, we believe the change in supervision requirements we are finalizing for RAs will contribute to burden reduction for physicians and practitioners providing diagnostic imaging procedures for Medicare beneficiaries. 5. Beneficiary Liability Many proposed policy changes could result in a change in beneficiary liability as it relates to coinsurance (which is 20 percent of the fee schedule amount, if applicable for the particular provision after the beneficiary has met the deductible). To illustrate this point, as shown in our public use file Impact on Payment for Selected Procedures available on the CMS website at https:// www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/ PhysicianFeeSched/, the CY 2018 national payment amount in the nonfacility setting for CPT code 99203 (Office/outpatient visit, new) was $109.80, which means that in CY 2018, a beneficiary would be responsible for 20 percent of this amount, or $21.96. Based on this final rule, using the CY 2019 CF, the CY 2019 national payment amount in the nonfacility setting for CPT code 99203, as shown in the Impact on Payment for Selected Procedures public use file, is $109.92, which means that, in CY 2019, the final beneficiary coinsurance for this service would be $21.98. PO 00000 Frm 00237 Fmt 4701 Sfmt 4700 60071 J. Impact on Beneficiaries in the Quality Payment Program There are several changes in this rule that would have an effect on beneficiaries. In general, we believe that many of these changes, including those intended to improve accuracy in payment through regular updates to the inputs used to calculate payments under the PFS, would have a positive impact and improve the quality and value of care provided to Medicare beneficiaries. For example, several of the new proposed measures include patientreported outcomes, which may be used to help patients make more informed decisions about treatment options. Patient-reported outcome measures provide information on a patient’s health status from the patient’s point of view and may also provide valuable insights on factors such as quality of life, functional status, and overall disease experience, which may not otherwise be available through routine clinical data collection. Patient-reported outcomes are factors frequently of interest to patients when making decisions about treatment.83 Further, the proposed policy changes in the Promoting Interoperability performance category shifts the focus to the interoperable, seamless exchange of electronic information. With the requirement that program participants use 2015 Edition CEHRT, the interoperable exchange of patient health information should be easier because the certification criteria are designed to facilitate information exchange. In combination with the newly proposed Promoting Interoperability measure to receive and incorporate health information, beneficiaries should begin to experience improved care coordination and care transitions because clinicians have improved access to the beneficiaries’ health information across the spectrum of care. Impact on Other Health Care Programs and Providers We estimate that CY 2019 Quality Payment Program will not have a significant economic effect on eligible clinicians and groups and believe that MIPS policies, along with increasing participation in APMs over time may succeed in improving quality and reducing costs. This may in turn result in beneficial effects on both patients and some clinicians, and we intend to continue focusing on clinician-driven, patient-centered care. 83 Institute of Medicine. 2013. Delivering HighQuality Cancer Care: Charting a New Course for a System in Crisis. Washington, DC: The National Academies Press. https://doi.org/10.17226/18359. E:\FR\FM\23NOR3.SGM 23NOR3 60072 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations K. Estimating Regulatory Familiarization Costs If regulations impose administrative costs on private entities, such as the time needed to read and interpret this rule, we should estimate the cost associated with regulatory review. Due to the uncertainty involved with accurately quantifying the number of entities that will review the rule, we assume that the total number of unique commenters on last year’s rule will be the number of reviewers of this rule. We acknowledge that this assumption may understate or overstate the costs of reviewing this rule. It is possible that not all commenters reviewed last year’s rule in detail, and it is also possible that some reviewers chose not to comment on the rule. For these reasons we thought that the number of past commenters would be a fair estimate of the number of reviewers of this rule. We welcomed any comments on the approach in estimating the number of entities which will review this rule. We also recognize that different types of entities are in many cases affected by mutually exclusive sections of this rule, and therefore for the purposes of our estimate we assume that each reviewer reads approximately 50 percent of the rule. We sought comments on this assumption. Using the wage information from the BLS for medical and health service managers (Code 11–9111), we estimate that the cost of reviewing this rule is $107.38 per hour, including overhead and fringe benefits https://www.bls.gov/ oes/current/oes_nat.htm. Assuming an average reading speed, we estimate that it would take approximately 8.0 hours for the staff to review half of this rule. For each facility that reviews the rule, the estimated cost is $859.04 (8.0 hours × $107.38). Therefore, we estimated that the total cost of reviewing this regulation is $5,105,275 ($859.04 × 5,943 reviewers). L. Accounting Statement As required by OMB Circular A–4 (available at https:// www.whitehouse.gov/omb/circulars/ a004/a-4.pdf), in Tables 106 and 107 (Accounting Statements), we have prepared an accounting statement. This estimate includes growth in incurred benefits from CY 2018 to CY 2019 based on the FY 2019 President’s Budget baseline. TABLE 106—ACCOUNTING STATEMENT: CLASSIFICATION OF ESTIMATED EXPENDITURES Category Transfers CY 2019 Annualized Monetized Transfers .............................................. From Whom To Whom? ........................................................................... Estimated increase in expenditures of $0.3 billion for PFS CF update. Federal Government to physicians, other practitioners and providers and suppliers who receive payment under Medicare. TABLE 107—ACCOUNTING STATEMENT: CLASSIFICATION OF ESTIMATED COSTS, TRANSFER, AND SAVINGS Category Transfer CY 2019 Annualized Monetized Transfers of beneficiary cost coinsurance. From Whom to Whom? ............................................................................ M. Conclusion The analysis in the previous sections, together with the remainder of this preamble, provided an initial Regulatory Flexibility Analysis. The previous analysis, together with the preceding portion of this preamble, provides an RIA. In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget. List of Subjects 42 CFR Part 405 Administrative practice and procedure, Diseases, Health facilities, Health professions, Medical devices, Medicare, Reporting and recordkeeping requirements, Rural areas, X-rays. amozie on DSK3GDR082PROD with RULES3 42 CFR Part 410 Health facilities, Health professions, Kidney diseases, Laboratories, Medicare, Reporting and recordkeeping requirements, Rural areas, X-rays. 42 CFR Part 411 Diseases, Medicare, Reporting and recordkeeping requirements. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 $0.1 billion. Beneficiaries to Federal Government. 42 CFR Part 414 Administrative practice and procedure, Biologics, Drugs, Health facilities, Health professions, Kidney diseases, Medicare, Reporting and recordkeeping requirements. 42 CFR Part 415 Health facilities, Health professions, Medicare, Reporting and recordkeeping requirements. 42 CFR Part 425 Administrative practice and procedure, Health facilities, Health professions, Medicare, Reporting and recordkeeping requirements. 42 CFR Part 495 Administrative practice and procedure, Health facilities, Health maintenance organizations (HMO), Health professions, Health records, Medicaid, Medicare, Penalties, Reporting and recordkeeping requirements. For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services amends 42 CFR chapter IV as set forth below: PO 00000 Frm 00238 Fmt 4701 Sfmt 4700 PART 405—FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED 1. The authority citation for part 405 is revised to read as follows: ■ Authority: 42 U.S.C. 405(a), 1302, 1320b– 12, 1395x, 1395y(a), 1395ff, 1395hh, 1395kk, 1395rr, and 1395ww(k)) and 42 U.S.C. 263a. 2. Section 405.2401 is amended in paragraph (b) by— ■ a. Revising the introductory text of the definition of ‘‘Federally qualified health center’’; and ■ b. Revising the definition of ‘‘Secretary’’. The revisions read as follows: ■ § 405.2401 Scope and definitions. * * * * * (b) * * * Federally qualified health center (FQHC) means an entity that has entered into an agreement with CMS to meet Medicare program requirements under § 405.2434 and— * * * * * E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations Secretary means the Secretary of Health and Human Services or his or her delegate. * * * * * ■ 3. Section 405.2462 is amended by revising paragraph (g) introductory text to read as follows: § 405.2462 services. Payment for RHC and FQHC * * * * * (g) To receive payment, the RHC or FQHC must do all of the following: * * * * * ■ 4. Section 405.2464 is amended by— ■ a. Revising paragraphs (a)(1), (b) heading, (b)(1), (c), and (d); and ■ b. Adding a new paragraph (e) The revisions and additions read as follows: amozie on DSK3GDR082PROD with RULES3 § 405.2464 Payment rate. (a) * * * (1) Except as specified in paragraphs (d) and (e) of this section, an RHC that is authorized to bill under the reasonable cost system is paid an allinclusive rate that is determined by the MAC at the beginning of the cost reporting period. * * * * * (b) Payment rate for FQHCs that are authorized to bill under the prospective payment system. (1) Except as specified in paragraphs (d) and (e) of this section, a per diem rate is calculated by CMS by dividing total FQHC costs by total FQHC daily encounters to establish an average per diem cost. * * * * * (c) Payment for care management services. For chronic care management services furnished between January 1, 2016 and December 31, 2017, payment to RHCs and FQHCs is at the physician fee schedule national non-facility payment rate. For care management services furnished on or after January 1, 2018, payment to RHCs and FQHCs is at the rate set for each of the RHC and FQHC payment codes for care management services. (d) Payment for FQHCs that are authorized to bill as grandfathered tribal FQHCs. Grandfathered tribal FQHCs are paid at the outpatient per visit rate for Medicare as set annually by the Indian Health Service for each beneficiary visit for covered services. There are no adjustments to this rate. (e) Payment for communication technology-based and remote evaluation services. For communication technology-based and remote evaluation services furnished on or after January 1, 2019, payment to RHCs and FQHCs is at the rate set for each of the RHC and FQHC payment codes for VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 communication technology-based and remote evaluation services. PART 410—SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS 5. The authority citation for part 410 is revised to read as follows: ■ Authority: 42 U.S.C. 1302, 1395m, 1395hh, 1395rr, and 1395ddd. 6. Section 410.32 is amended by adding paragraph (b)(4) to read as follows: ■ § 410.32 Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions. * * * * * (b) * * * (4) Supervision requirement for RRA or RPA. Diagnostic tests that are performed by a registered radiologist assistant (RRA) who is certified and registered by the American Registry of Radiologic Technologists or a radiology practitioner assistant (RPA) who is certified by the Certification Board for Radiology Practitioner Assistants, and that would otherwise require a personal level of supervision as specified in paragraph (b)(3) of this section, may be furnished under a direct level of physician supervision to the extent permitted by state law and state scope of practice regulations. * * * * * § 410.59 [Amended] 7. Section 410.59 is amended by removing paragraph (a)(4). ■ § 410.60 [Amended] 8. Section 410.60 is amended by removing paragraph (a)(4). ■ 9. Section 410.61 is amended by revising paragraph (c) to read as follows: ■ § 410.61 Plan of treatment requirements for outpatient rehabilitation services. * * * * * (c) Content of the plan. The plan prescribes the type, amount, frequency, and duration of the physical therapy, occupational therapy, or speechlanguage pathology services to be furnished to the individual, and indicates the diagnosis and anticipated goals. * * * * * § 410.62 [Amended] 10. Section 410.62 is amended by removing paragraph (a)(4). ■ 11. Section 410.78 is amended by— ■ a. Adding paragraphs (b)(3)(ix), (x), (xi), and (xii); ■ b. Revising paragraph (b)(4) introductory text, and ■ PO 00000 Frm 00239 Fmt 4701 Sfmt 4700 60073 c. Adding paragraph (b)(4)(iv). The additions and revision read as follows: ■ § 410.78 Telehealth services. * * * * * (b) * * * (3) * * * (ix) A renal dialysis facility (only for purposes of the home dialysis monthly ESRD-related clinical assessment in section 1881(b)(3)(B) of the Act); (x) The home of an individual (only for purposes of the home dialysis ESRDrelated clinical assessment in section 1881(b)(3)(B) of the Act). (xi) A mobile stroke unit (only for purposes of diagnosis, evaluation, or treatment of symptoms of an acute stroke provided in accordance with section 1834(m)(6) of the Act). (xii) The home of an individual (only for purposes of treatment of a substance use disorder or a co-occurring mental health disorder, furnished on or after July 1, 2019, to an individual with a substance use disorder diagnosis. (4) Except as provided in paragraph (b)(4)(iv) of this section, originating sites must be: * * * * * (iv) The geographic requirements specified in paragraph (b)(4) of this section do not apply to the following telehealth services: (A) Home dialysis monthly ESRDrelated clinical assessment services furnished on or after January 1, 2019, at an originating site described in paragraphs (b)(3)(vi), (ix) or (x) of this section, in accordance with section 1881(b)(3)(B) of the Act; and (B) Services furnished on or after January 1, 2019, for purposes of diagnosis, evaluation, or treatment of symptoms of an acute stroke. (C) Services furnished on or after July 1, 2019 to an individual with a substance use disorder diagnosis, for purposes of treatment of a substance use disorder or a co-occurring mental health disorder. * * * * * § 410.105 [Amended] 12. Section 410.105 is amended— a. In paragraph (c)(1)(ii) by removing the phrase ‘‘that are consistent with the patient function reporting on the claims for services’’; and ■ b. By removing paragraph (d). ■ ■ PART 411—EXCLUSIONS FROM MEDICARE AND LIMITATIONS ON MEDICARE PAYMENT 13. The authority citation for part 411 is revised to read as follows: ■ Authority: 42 U.S.C. 1302, 1395w–101 through 1395w–152, 1395hh, and 1395nn. E:\FR\FM\23NOR3.SGM 23NOR3 60074 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 14. Section 411.353 is amended by— a. Revising paragraph (g)(1); and b. Removing and reserving paragraph (g)(2). The revision reads as follows: ■ ■ ■ § 411.353 Prohibition on certain referrals by physicians and limitations on billing. * * * * * (g) * * * (1) An entity may submit a claim or bill and payment may be made to an entity that submits a claim or bill for a designated health service if— (i) The compensation arrangement between the entity and the referring physician fully complies with an applicable exception in this subpart except with respect to the signature requirement of the exception; and (ii) The parties obtain the required signature(s) within 90 consecutive calendar days immediately following the date on which the compensation arrangement became noncompliant and the compensation arrangement otherwise complies with all criteria of the applicable exception. (2) [Reserved] ■ 15. Section 411.354 is amended by adding paragraph (e) to read as follows: § 411.354 Financial relationship, compensation, and ownership or investment interest. * * * * * (e) Special rule on compensation arrangements—(1) Application. This paragraph (e) applies only to compensation arrangements as defined in section 1877 of the Act and this subpart. (2) Writing requirement. In the case of any requirement in this subpart for a compensation arrangement to be in writing, such requirement may be satisfied by a collection of documents, including contemporaneous documents evidencing the course of conduct between the parties. PART 414—PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES 16. The authority citation for part 414 is revised to read as follows: ■ Authority: 42 U.S.C. 1302, 1395hh, and 1395rr(b)(l). 17. Section 414.65 is amended by— a. Revising paragraph (a) introductory text; ■ b. Removing paragraph (a)(1); ■ c. Redesignating paragraphs (a)(2) and (3), as paragraphs (a)(1) and (2), respectively; and ■ d. Adding paragraph (b)(3). The revision and addition reads as follows: amozie on DSK3GDR082PROD with RULES3 ■ ■ VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 § 414.65 Payment for telehealth services. (a) Professional service. The Medicare payment amount for telehealth services described under § 410.78 of this chapter is equal to the current fee schedule amount applicable for the service of the physician or practitioner, subject to paragraphs (a)(1) and (2) of this section, but must be made in accordance with the following limitations: * * * * * (b) * * * (3) No originating site facility fee payment is made to an originating site described in § 410.78(b)(3)(x), (xi), or (xii); or to an originating site for services furnished under the exception at § 410.78(b)(4)(iv)(A) or (B) of this chapter. * * * * * ■ 18. Section 414.94 is amended— ■ a. In paragraph (b), by revising the definition of ‘‘Applicable setting’’; and ■ b. By revising paragraphs (i)(3), (j), and (k) introductory text. The revisions read as follows: § 414.94 Appropriate use criteria for advanced diagnostic imaging services. * * * * * (b) * * * Applicable setting means a physician’s office, a hospital outpatient department (including an emergency department), an ambulatory surgical center, an independent diagnostic testing facility, and any other providerled outpatient setting determined appropriate by the Secretary. * * * * * (i) * * * (3) Significant hardships for ordering professionals who experience any of the following: (i) Insufficient internet access. (ii) EHR or CDSM vendor issues. (iii) Extreme and uncontrollable circumstances. (j) Consulting. (1) Except as specified in paragraphs (i) and (j)(2) of this section, ordering professionals must consult specified applicable AUC through qualified CDSMs for applicable imaging services furnished in an applicable setting, paid for under an applicable payment system, and ordered on or after January 1, 2020. (2) Ordering professionals may delegate the consultation with specified applicable AUC required under paragraph (j)(1) of this section to clinical staff acting under the direction of the ordering professional. (k) Reporting. The following information must be reported on Medicare claims for advanced diagnostic imaging services furnished in an applicable setting, paid for under an PO 00000 Frm 00240 Fmt 4701 Sfmt 4700 applicable payment system defined in paragraph (b) of this section, and ordered on or after January 1, 2020: * * * * * ■ 19. Section 414.502 is amended in the definition of ‘‘Applicable laboratory’’ by adding paragraph (2)(i), adding and reserving paragraph (2)(ii), and revising paragraph (3) introductory text to read as follows: § 414.502 Definitions. * * * * * Applicable laboratory * * * (2) * * * (i) For hospital outreach laboratories—bills Medicare Part B on the CMS 1450 under bill type 14x; (ii) [Reserved] (3) In a data collection period, receives more than 50 percent of its Medicare revenues, which includes feefor-service payments under Medicare Parts A and B, prescription drug payments under Medicare Part D, and any associated Medicare beneficiary deductible or coinsurance for services furnished during the data collection period from one or a combination of the following sources: * * * * * ■ 20. Section 414.610 is amended— ■ a. In paragraphs (c)(1)(ii) introductory text and (c)(5)(ii) by removing the date ‘‘December 31, 2017’’ and adding in its place the date ‘‘December 31, 2022’’; and ■ b. By revising paragraph (c)(8). The revision reads as follows: § 414.610 Basis of payment. * * * * * (c) * * * (8) Transport of an individual with end-stage renal disease for renal dialysis services. For ambulance services furnished during the period October 1, 2013 through September 30, 2018, consisting of non-emergency basic life support (BLS) services involving transport of an individual with endstage renal disease for renal dialysis services (as described in section 1881(b)(14)(B) of the Act) furnished other than on an emergency basis by a provider of services or a renal dialysis facility, the fee schedule amount otherwise applicable (both base rate and mileage) is reduced by 10 percent. For such services furnished on or after October 1, 2018, the fee schedule amount otherwise applicable (both base rate and mileage) is reduced by 23 percent. * * * * * § 414.904 [Amended] 21. Section 414.904 is amended in paragraph (e)(4) by removing the phrase ■ E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations ‘‘acquisition cost or the applicable Medicare Part B drug payment’’ and adding in its place the phrase ‘‘acquisition cost or the Medicare Part B drug payment’’. ■ 22. Section 414.1305 is amended by— ■ a. Revising the definition of ‘‘Ambulatory Surgical Center (ASC)based MIPS eligible clinician’’; ■ b. Adding in alphabetical order definitions for ‘‘Collection type’’ and ‘‘Health IT vendor’’; ■ c. Revising the definitions of ‘‘High priority measure’’, ‘‘Hospital-based MIPS eligible clinician’’, and ‘‘Lowvolume threshold’’; ■ d. Adding in alphabetical order a definition for ‘‘MIPS determination period’’; ■ e. Revising the definitions of ‘‘MIPS eligible clinician’’, ‘‘Non-patient facing MIPS eligible clinician’’, ‘‘Qualified Clinical Data Registry (QCDR)’’, ‘‘Qualifying APM Participant (QP)’’, and ‘‘Small practice’’; and ■ f. Adding in alphabetical order a definition for ‘‘Submission type’’, ‘‘Submitter type’’, and ‘‘Third party intermediary’’. The revisions and additions read as follows: § 414.1305 Definitions. amozie on DSK3GDR082PROD with RULES3 * * * * * Ambulatory Surgical Center (ASC)based MIPS eligible clinician means: (1) For the 2019 and 2020 MIPS payment years, a MIPS eligible clinician who furnishes 75 percent or more of his or her covered professional services in sites of service identified by the Place of Service (POS) codes used in the HIPAA standard transaction as an ambulatory surgical center setting based on claims for a period prior to the performance period as specified by CMS; and (2) Beginning with the 2021 MIPS payment year, a MIPS eligible clinician who furnishes 75 percent or more of his or her covered professional services in sites of service identified by the POS codes used in the HIPAA standard transaction as an ambulatory surgical center setting based on claims for the MIPS determination period. * * * * * Collection type means a set of quality measures with comparable specifications and data completeness criteria, as applicable, including, but not limited to: electronic clinical quality measures (eCQMs); MIPS Clinical Quality Measures (MIPS CQMs), QCDR measures, Medicare Part B claims measures, CMS Web Interface measures, the CAHPS for MIPS survey, and administrative claims measures. * * * * * VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 Health IT vendor means an entity that supports the health IT requirements on behalf of a MIPS eligible clinician (including obtaining data from a MIPS eligible clinician’s CEHRT). * * * * * High priority measure means: (1) For the 2019 and 2020 MIPS payment years, an outcome (including intermediate-outcome and patientreported outcome), appropriate use, patient safety, efficiency, patient experience, or care coordination quality measure. (2) Beginning with the 2021 MIPS payment year, an outcome (including intermediate-outcome and patientreported outcome), appropriate use, patient safety, efficiency, patient experience, care coordination, or opioid-related quality measure. Hospital-based MIPS eligible clinician means: (1) For the 2019 and 2020 MIPS payment years, a MIPS eligible clinician who furnishes 75 percent or more of his or her covered professional services in sites of service identified by the Place of Service (POS) codes used in the HIPAA standard transaction as an inpatient hospital, on-campus outpatient hospital, off campus-outpatient hospital, or emergency room setting based on claims for a period prior to the performance period as specified by CMS; and (2) Beginning with the 2021 MIPS payment year, a MIPS eligible clinician who furnishes 75 percent or more of his or her covered professional services in sites of service identified by the POS codes used in the HIPAA standard transaction as an inpatient hospital, oncampus outpatient hospital, off campus outpatient hospital, or emergency room setting based on claims for the MIPS determination period. * * * * * Low-volume threshold means: (1) For the 2019 MIPS payment year, the low-volume threshold that applies to an individual eligible clinician, group, or APM Entity group that, during the low-volume threshold determination period described in paragraph (4) of this definition, has Medicare Part B allowed charges less than or equal to $30,000 or provides care for 100 or fewer Medicare Part B-enrolled individuals. (2) For the 2020 MIPS payment year, the low-volume threshold that applies to an individual eligible clinician, group, or APM Entity group that, during the low-volume threshold determination period described in paragraph (4) of this definition, has allowed charges for covered professional services less than or equal to $90,000 or furnishes covered professional services to 200 or fewer Medicare Part B-enrolled individuals. PO 00000 Frm 00241 Fmt 4701 Sfmt 4700 60075 (3) Beginning with the 2021 MIPS payment year, the low-volume threshold that applies to an individual eligible clinician, group, or APM Entity group that, during the MIPS determination period, has allowed charges for covered professional services less than or equal to $90,000, furnishes covered professional services to 200 or fewer Medicare Part B-enrolled individuals, or furnishes 200 or fewer covered professional services to Medicare Part Benrolled individuals. (4) For the 2019 and 2020 MIPS payment years, the low-volume threshold determination period is a 24month assessment period consisting of: (i) An initial 12-month segment that spans from the last 4 months of the calendar year 2 years prior to the performance period through the first 8 months of the calendar year preceding to the performance period; and (ii) A second 12-month segment that spans from the last 4 months of the calendar year 1 year prior to the performance period through the first 8 months of the calendar year performance period. An individual eligible clinician, group, or APM Entity group that is identified as not exceeding the low-volume threshold during the initial 12-month segment will continue to be excluded under § 414.1310(b)(1)(iii) for the applicable year regardless of the results of the second 12-month segment analysis. For the 2019 MIPS payment year, each segment of the low-volume threshold determination period includes a 60-day claims run out. For the 2020 MIPS payment year, each segment of the lowvolume threshold determination period includes a 30-day claims run out. * * * * * MIPS determination period means: (1) Beginning with the 2021 MIPS payment year, a 24-month assessment period consisting of: (i) An initial 12-month segment beginning on October 1 of the calendar year 2 years prior to the applicable performance period and ending on September 30 of the calendar year preceding the applicable performance period, and that includes a 30-day claims run out; and (ii) A second 12-month segment beginning on October 1 of the calendar year preceding the applicable performance period and ending on September 30 of the calendar year in which the applicable performance period occurs. (2) Subject to § 414.1310(b)(1)(iii), an individual eligible clinician, group, or APM Entity group that is identified as not exceeding the low-volume threshold E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 60076 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations or as having special status during the first segment of the MIPS determination period will be identified as such for the applicable MIPS payment year regardless of the results of the second segment of the MIPS determination period. An individual eligible clinician, group, or APM Entity group for which the unique billing TIN and NPI combination is established during the second segment of the MIPS determination period will be assessed based solely on the results of such segment. MIPS eligible clinician as identified by a unique billing TIN and NPI combination used to assess performance, means any of the following (except as excluded under § 414.1310(b)): (1) For the 2019 and 2020 MIPS payment years: (i) A physician (as defined in section 1861(r) of the Act); (ii) A physician assistant, a nurse practitioner, and clinical nurse specialist (as such terms are defined in section 1861(aa)(5) of the Act); (iii) A certified registered nurse anesthetist (as defined in section 1861(bb)(2) of the Act); and (iv) A group that includes such clinicians. (2) For the 2021 MIPS payment year and future years: (i) A clinician described in paragraph (1) of this definition; (ii) A physical therapist or occupational therapist; (iii) A qualified speech-language pathologist; (iv) A qualified audiologist (as defined in section 1861(ll)(3)(B) of the Act); (v) A clinical psychologist (as defined by the Secretary for purposes of section 1861(ii) of the Act); (vi) A registered dietician or nutrition professional; and (vii) A group that includes such clinicians. * * * * * Non-patient facing MIPS eligible clinician means: (1) For the 2019 and 2020 MIPS payment year, an individual MIPS eligible clinician who bills 100 or fewer patient facing encounters (including Medicare telehealth services defined in section 1834(m) of the Act), as described in paragraph (3) of this definition, during the non-patient facing determination period described in paragraph (4) of this definition, and a group or virtual group provided that more than 75 percent of the NPIs billing under the group’s TIN or virtual group’s TINs, as applicable, meet the definition VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 of a non-patient facing individual MIPS eligible clinician. (2) Beginning with the 2021 MIPS payment year, an individual MIPS eligible clinician who bills 100 or fewer patient facing encounters (including Medicare telehealth services defined in section 1834(m) of the Act), as described in paragraph (3) of this definition, during the MIPS determination period, and a group or virtual group provided that more than 75 percent of the NPIs billing under the group’s TIN or virtual group’s TINs, as applicable, meet the definition of a non-patient facing individual MIPS eligible clinician. (3) For purposes of this definition, a patient-facing encounter is an instance in which the individual MIPS eligible clinician or group bills for items and services furnished such as general office visits, outpatient visits, and procedure codes under the PFS, as specified by CMS. (4) For the 2019 and 2020 MIPS payment year, the non-patient facing determination period is a 24-month assessment period consisting of: (i) An initial 12-month segment that spans from the last 4 months of the calendar year 2 years prior to the performance period through the first 8 months of the calendar year preceding the performance period; and (ii) A second 12-month segment that spans from the last 4 months of the calendar year 1 year prior to the performance period through the first 8 months of the calendar year performance period. An individual eligible MIPS clinician, group, or virtual group that is identified as non-patient facing during the initial 12-month segment will continue to be considered non-patient facing for the applicable year regardless of the results of the second 12-month segment analysis. For the 2019 MIPS payment year, each segment of the non-patient facing determination period includes a 60-day claims run out. For the 2020 MIPS payment year and future years, each segment of the non-patient facing determination period includes a 30-day claims run out. * * * * * Qualified clinical data registry (QCDR) means: (1) For the 2019, 2020 and 2021 MIPS payment year, a CMS-approved entity that has self-nominated and successfully completed a qualification process to determine whether the entity may collect medical or clinical data for the purpose of patient and disease tracking to foster improvement in the quality of care provided to patients. (2) Beginning with the 2022 MIPS payment year, an entity that PO 00000 Frm 00242 Fmt 4701 Sfmt 4700 demonstrates clinical expertise in medicine and quality measurement development experience and collects medical or clinical data on behalf of a MIPS eligible clinician for the purpose of patient and disease tracking to foster improvement in the quality of care provided to patients. * * * * * Qualifying APM participant (QP) means an eligible clinician determined by CMS to have met or exceeded the relevant QP payment amount or QP patient count threshold under § 414.1430(a)(1), (a)(3), (b)(1), or (b)(3) for a year based on participation in an APM Entity that is also participating in an Advanced APM. * * * * * Small practice means: (1) For the 2019 MIPS payment year, a TIN consisting of 15 or fewer eligible clinicians. (2) For the 2020 MIPS payment year, a TIN consisting of 15 or fewer eligible clinicians during a 12-month assessment period that spans from the last 4 months of the calendar year 2 years prior to the performance period through the first 8 months of the calendar year preceding the performance period and includes a 30day claims run out. (3) Beginning with the 2021 MIPS payment year, a TIN consisting of 15 or fewer eligible clinicians during the MIPS determination period. * * * * * Submission type means the mechanism by which the submitter type submits data to CMS, including, but not limited to: Direct, log in and upload, log in and attest, Medicare Part B claims and the CMS Web Interface. Submitter type means the MIPS eligible clinician, group, virtual group, or third party intermediary acting on behalf of a MIPS eligible clinician, group, or virtual group, as applicable, that submits data on measures and activities under MIPS. Third party intermediary means an entity that has been approved under § 414.1400 to submit data on behalf of a MIPS eligible clinician, group, or virtual group for one or more of the quality, improvement activities, and promoting interoperability performance categories. * * * * * ■ 23. Section 414.1310 is amended by revising paragraphs (a), (b)(1)(ii), (iii), (d), (e)(1) and (2) to read as follows: § 414.1310 Applicability. (a) Program implementation. Except as specified in paragraph (b) of this section, MIPS applies to payments for E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations covered professional services furnished by MIPS eligible clinicians on or after January 1, 2019. (b) * * * (1) * * * (ii) Is a Partial Qualifying APM Participant and does not elect to participate in MIPS as a MIPS eligible clinician; or (iii) Does not exceed the low-volume threshold. Beginning with the 2021 MIPS payment year, if an individual eligible clinician, group, or APM Entity group in a MIPS APM exceeds at least one, but not all, of the low-volume threshold criteria and elects to participate in MIPS as a MIPS eligible clinician, the individual eligible clinician, group, or APM Entity group is treated as a MIPS eligible clinician for the applicable MIPS payment year. For such solo practitioners and groups that elect to participate in MIPS as a virtual group (except for APM Entity groups in MIPS APMs), the virtual group election under § 414.1315 constitutes an election under this paragraph and results in the solo practitioners and groups being treated as MIPS eligible clinicians for the applicable MIPS payment year. For such APM Entity groups in MIPS APMs, only the APM Entity group election can result in the APM Entity group being treated as MIPS eligible clinicians for the applicable MIPS payment year. * * * * * (d) Clarification. In no case will a MIPS payment adjustment factor (or additional MIPS payment adjustment factor) apply to payments for items and services furnished during a year by a eligible clinician, including an eligible clinician described in paragraph (b) or (c) of this section, who is not a MIPS eligible clinician, including an eligible clinician who voluntarily reports on applicable measures and activities under MIPS. (e) * * * (1) Except as provided under § 414.1370(f)(2), each MIPS eligible clinician in the group will receive a MIPS payment adjustment factor (or additional MIPS payment adjustment factor) based on the group’s combined performance assessment. (2) For individual MIPS eligible clinicians to participate in MIPS as a group, all of the following requirements must be met: (i) Groups must meet the definition of a group at all times during the applicable performance period. (ii) Individual eligible clinicians that elect to participate in MIPS as a group must aggregate their performance data across the group’s TIN. (iii) Individual eligible clinicians that elect to participate in MIPS as a group VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 will have their performance assessed at the group level across all four MIPS performance categories. (iv) Groups must adhere to an election process established by CMS, as applicable. * * * * * ■ 24. Section 414.1315 is revised to read as follows: § 414.1315 Virtual groups. (a) Eligibility. (1) For a MIPS payment year, a solo practitioner or a group of 10 or fewer eligible clinicians may elect to participate in MIPS as a virtual group with at least one other such solo practitioner or group. The election must be made prior to the start of the applicable performance period and cannot be changed during the performance period. A solo practitioner or group may elect to be in no more than one virtual group for a performance period, and, in the case of a group, the election applies to all MIPS eligible clinicians in the group. (2) Except as provided under § 414.1370(f)(2), each MIPS eligible clinician in the virtual group receives a MIPS payment adjustment factor and, if applicable, an additional MIPS payment adjustment factor based on the virtual group’s combined performance assessment. (b) Election deadline. The election deadline is December 31 of the calendar year preceding the applicable performance period. (c) Election process. For the 2020 MIPS payment year and future years, the virtual group election process is as follows: (1) Stage 1: Virtual group eligibility determination. (i) For the 2020 MIPS payment year, the virtual group eligibility determination period is an assessment period of up to 5 months beginning on July 1 and ending as late as November 30 of the calendar year preceding the applicable performance period, and that includes a 30-day claims run out. (ii) Beginning with the 2021 MIPS payment year, the virtual group eligibility determination period is the first segment of the MIPS determination period. (2) Stage 2: Virtual group formation. (i) Solo practitioners and groups that elect to participate in MIPS as a virtual group must establish a formal written agreement that satisfies paragraph (c)(3) of this section prior to the election. (ii) A designated virtual group representative must submit an election, on behalf of the solo practitioners and groups that compose a virtual group, to participate in MIPS as a virtual group PO 00000 Frm 00243 Fmt 4701 Sfmt 4700 60077 for a performance period in a form and manner specified by CMS by the election deadline specified in paragraph (b) of this section. The virtual group election must include each TIN and NPI associated with the virtual group and contact information for the virtual group representative. (iii) After an election is made, the virtual group representative must contact their designated CMS contact to update any election information that changed during a performance period at least one time prior to the start of data submission. (3) Virtual group agreement. The virtual group arrangement must be set forth in a formal written agreement among the parties, consisting of each solo practitioner and group that composes a virtual group. The agreement must comply with the following requirements: (i) Identifies each party by name, TIN, and each NPI under the TIN, and includes as parties only the solo practitioners and groups that compose the virtual group. (ii) Is for a term of at least one performance period. (iii) Requires each party to notify each NPI under the party’s TIN regarding their participation in the MIPS as a virtual group. (iv) Sets forth each NPI’s rights and obligations in, and representation by, the virtual group, including, but not limited to, the reporting requirements and how participation in the MIPS as a virtual group affects the NPI’s ability to participate in the MIPS outside of the virtual group. (v) Describes how the opportunity to receive payment adjustments will encourage each member of the virtual group (and each NPI under each TIN in the virtual group) to adhere to quality assurance and improvement. (vi) Requires each party to update its Medicare enrollment information, including the addition or removal of NPIs billing under its TIN, on a timely basis in accordance with Medicare program requirements and to notify the other parties of any such changes within 30 days of the change. (vii) Requires completion of a closeout process upon termination or expiration of the agreement that requires each party to furnish all data necessary for the parties to aggregate their data across the virtual group’s TINs. (viii) Expressly requires each party to participate in the MIPS as a virtual group and comply with the requirements of the MIPS and all other applicable laws (including, but not limited to, Federal criminal law, the Federal False Claims Act, the Federal E:\FR\FM\23NOR3.SGM 23NOR3 60078 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations anti-kickback statute, the Federal civil monetary penalties law, the Federal physician self-referral law, and the Health Insurance Portability and Accountability Act of 1996). (ix) Is executed on behalf of each party by an individual who is authorized to bind the party. (d) Virtual group reporting requirements. For solo practitioners and groups of 10 or fewer eligible clinicians to participate in MIPS as a virtual group, all of the following requirements must be met: (1) Virtual groups must meet the definition of a virtual group at all times during the applicable performance period. (2) Solo practitioners and groups of 10 or fewer eligible clinicians that elect to participate in MIPS as a virtual group must aggregate their performance data across the virtual group’s TINs. (3) Solo practitioners and groups of 10 or fewer eligible clinicians that elect to participate in MIPS as a virtual group will have their performance assessed at the virtual group level across all four MIPS performance categories. (4) Virtual groups must adhere to the election process described in paragraph (c) of this section. ■ 25. Section 414.1320 is amended by revising paragraphs (b)(2) and (c)(2) and adding paragraphs (d) and (e) to read as follows: § 414.1320 MIPS performance period. amozie on DSK3GDR082PROD with RULES3 * * * * * (b) * * * (2) Promoting Interoperability and improvement activities performance categories is a minimum of a continuous 90-day period within CY 2018, up to and including the full CY 2018 (January 1, 2018 through December 31, 2018). (c) * * * (2) Promoting Interoperability and improvement activities performance categories is a minimum of a continuous 90-day period within CY 2019, up to and including the full CY 2019 (January 1, 2019 through December 31, 2019). (d) Beginning with the 2022 MIPS payment year, the performance period for: (1) The quality and cost performance categories is the full calendar year (January 1 through December 31) that occurs 2 years prior to the applicable MIPS payment year. (2) The improvement activities performance categories is a minimum of a continuous 90-day period within the calendar year that occurs 2 years prior to the applicable MIPS payment year, up to and including the full calendar year. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 (e) For purposes of the 2022 MIPS payment year, the performance period for: (1) The Promoting Interoperability performance category is a minimum of a continuous 90-day period within the calendar year that occurs 2 years prior to the applicable MIPS payment year, up to and including the full calendar year. (2) [Reserved] ■ 26. Section 414.1325 is revised to read as follows: § 414.1325 Data submission requirements. (a) Applicable performance categories. (1) Except as provided in paragraph (a)(2) of this section or under § 414.1370, as applicable, individual MIPS eligible clinicians and groups must submit data on measures and activities for the quality, improvement activities, and Promoting Interoperability performance categories in accordance with this section. Except for the Medicare Part B claims submission type, the data may also be submitted on behalf of the individual MIPS eligible clinician or group by a third party intermediary described at § 414.1400. (2) There are no data submission requirements for: (i) The cost performance category or administrative claims-based quality measures. Performance in the cost performance category and on such measures is calculated by CMS using administrative claims data, which includes claims submitted with dates of service during the applicable performance period that are processed no later than 60 days following the close of the applicable performance period. (ii) The quality and cost performance categories, as applicable, for MIPS eligible clinicians and groups that are scored under the facility-based measurement scoring methodology described in § 414.1380(e). (b) Data submission types for individual MIPS eligible clinicians. An individual MIPS eligible clinician may submit their MIPS data using: (1) For the quality performance category, the direct, login and upload, and Medicare Part B claims (beginning with the 2021 MIPS payment year for small practices only) submission types. (2) For the improvement activities or Promoting Interoperability performance categories, the direct, login and upload, or login and attest submission types. (c) Data submission types for groups. Groups may submit their MIPS data using: (1) For the quality performance category, the direct, login and upload, Medicare Part B claims (beginning with PO 00000 Frm 00244 Fmt 4701 Sfmt 4700 the 2021 MIPS payment year, for small practices only), and CMS Web Interface (for groups consisting of 25 or more eligible clinicians or a third party intermediary submitting on behalf of a group) submission types. (2) For the improvement activities or Promoting Interoperability performance categories, the direct, login and upload, or login and attest submission types. (d) Use of multiple data submission types. Beginning with the 2021 MIPS payment year, MIPS eligible clinicians, groups, and virtual groups may submit their MIPS data using multiple data submission types for any performance category described in paragraph (a)(1) of this section, as applicable; provided, however, that the MIPS eligible clinician, group, or virtual group uses the same identifier for all performance categories and all data submissions. (e) Data submission deadlines. The data submission deadlines are as follows: (1) For the direct, login and upload, login and attest, and CMS Web Interface submission types, March 31 following the close of the applicable performance period or a later date as specified by CMS. (2) For the Medicare Part B claims submission type, data must be submitted on claims with dates of service during the applicable performance period that must be processed no later than 60 days following the close of the applicable performance period. ■ 27. Section 414.1330 is revised to read as follows: § 414.1330 Quality performance category. (a) For a MIPS payment year, CMS uses the following quality measures, as applicable, to assess performance in the quality performance category: (1) Measures included in the MIPS final list of quality measures established by CMS through rulemaking; (2) QCDR measures approved by CMS under § 414.1400; (3) Facility-based measures described in § 414.1380; and (4) MIPS APM measures described in § 414.1370. (b) Unless a different scoring weight is assigned by CMS, performance in the quality performance category comprises: (1) 60 percent of a MIPS eligible clinician’s final score for MIPS payment year 2019. (2) 50 percent of a MIPS eligible clinician’s final score for MIPS payment year 2020. (3) 45 percent of a MIPS eligible clinician’s final score for MIPS payment year 2021. E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 28. Section 414.1335 is amended by revising paragraphs (a)(1) through (3) to read as follows: ■ § 414.1335 Data submission criteria for the quality performance category. (a) * * * (1) For Medicare Part B claims measures, MIPS CQMs, eCQMs, or QCDR measures. (i) Except as provided in paragraph (a)(1)(ii) of this section, submit data on at least six measures, including at least one outcome measure. If an applicable outcome measure is not available, report one other high priority measure. If fewer than six measures apply to the MIPS eligible clinician or group, report on each measure that is applicable. (ii) MIPS eligible clinicians and groups that report on a specialty or subspecialty measure set, as designated in the MIPS final list of quality measures established by CMS through rulemaking, must submit data on at least six measures within that set, including at least one outcome measure. If an applicable outcome measure is not available, report one other high priority measure. If the set contains fewer than six measures or if fewer than six measures within the set apply to the MIPS eligible clinician or group, report on each measure that is applicable. (2) For CMS Web Interface measures. (i) Report on all measures included in the CMS Web Interface. The group is required to report on at least one measure for which there is Medicare patient data. (ii) [Reserved] (3) For the CAHPS for MIPS survey. (i) For the 12-month performance period, a group that wishes to voluntarily elect to participate in the CAHPS for MIPS survey must use a survey vendor that is approved by CMS for the applicable performance period to transmit survey measures data to CMS. (ii) [Reserved] * * * * * ■ 29. Section 414.1340 is amended by revising paragraphs (a) introductory text, (b) introductory text, and (c) to read as follows: amozie on DSK3GDR082PROD with RULES3 § 414.1340 Data completeness criteria for the quality performance category. (a) MIPS eligible clinicians and groups submitting quality measures data on QCDR measures, MIPS CQMs, or eCQMs must submit data on: * * * * * (b) MIPS eligible clinicians and groups submitting quality measure data on Medicare Part B claims measures must submit data on: * * * * * VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 (c) Groups submitting quality measures data on CMS Web Interface measures or the CAHPS for MIPS survey must submit data on the sample of the Medicare Part B patients CMS provides, as applicable. (1) For CMS Web Interface measures. (i) The group must report on the first 248 consecutively ranked beneficiaries in the sample for each measure or module. If the sample of eligible assigned beneficiaries is less than 248, then the group must report on 100 percent of assigned beneficiaries. (ii) [Reserved] (2) [Reserved] ■ 30. Section 414.1350 is revised to read as follows: § 414.1350 Cost performance category. (a) Specification of cost measures. For purposes of assessing performance of MIPS eligible clinicians on the cost performance category, CMS specifies cost measures for a performance period. (b) Attribution. (1) Cost measures are attributed at the TIN/NPI level. (2) For the total per capita cost measure, beneficiaries are attributed using a method generally consistent with the method of assignment of beneficiaries under § 425.402 of this chapter. (3) For the Medicare Spending per Beneficiary (MSPB) measure, an episode is attributed to the MIPS eligible clinician who submitted the plurality of claims (as measured by allowed charges) for Medicare Part B services rendered during an inpatient hospitalization that is an index admission for the MSPB measure during the applicable performance period. (4) For the acute condition episodebased measures specified for the 2017 performance period, an episode is attributed to each MIPS eligible clinician who bills at least 30 percent of inpatient evaluation and management (E&M) visits during the trigger event for the episode. (5) For the procedural episode-based measures specified for the 2017 performance period, an episode is attributed to each MIPS eligible clinician who bills a Medicare Part B claim with a trigger code during the trigger event for the episode. (6) For the acute inpatient medical condition episode-based measures specified beginning with the 2019 performance period, an episode is attributed to each MIPS eligible clinician who bills inpatient E&M claim lines during a trigger inpatient hospitalization under a TIN that renders at least 30 percent of the inpatient E&M claim lines in that hospitalization. PO 00000 Frm 00245 Fmt 4701 Sfmt 4700 60079 (7) For the procedural episode-based measures specified beginning with the 2019 performance period, an episode is attributed to each MIPS eligible clinician who renders a trigger service as identified by HCPCS/CPT procedure codes. (c) Case minimums. (1) For the total per capita cost measure, the case minimum is 20. (2) For the Medicare spending per beneficiary measure, the case minimum is 35. (3) For the episode-based measures specified for the 2017 performance period, the case minimum is 20. (4) For the procedural episode-based measures specified beginning with the 2019 performance period, the case minimum is 10. (5) For the acute inpatient medical condition episode-based measures specified beginning with the 2019 performance period, the case minimum is 20. (d) Scoring weight. Unless a different scoring weight is assigned by CMS under section 1848(q)(5)(F) of the Act, performance in the cost performance category comprises: (1) Zero percent of a MIPS eligible clinician’s final score for MIPS payment year 2019. (2) 10 percent of a MIPS eligible clinician’s final score for MIPS payment year 2020. (3) 15 percent of a MIPS eligible clinician’s final score for MIPS payment year 2021. ■ 31. Section 414.1355 is amended by revising paragraphs (a), (b) introductory text, and (c) to read as follows: § 414.1355 Improvement activities performance category. (a) For a MIPS payment year, CMS uses improvement activities included in the MIPS final inventory of improvement activities established by CMS through rulemaking to assess performance in the improvement activities performance category. (b) Unless a different scoring weight is assigned by CMS under section 1848(q)(5)(F) of the Act, performance in the improvement activities performance category comprises: * * * * * (c) The following are the list of subcategories, of which, with the exception of Participation in an APM, include activities for selection by a MIPS eligible clinician or group: (1) Expanded practice access, such as same day appointments for urgent needs and after-hours access to clinician advice. (2) Population management, such as monitoring health conditions of E:\FR\FM\23NOR3.SGM 23NOR3 60080 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations amozie on DSK3GDR082PROD with RULES3 individuals to provide timely health care interventions or participation in a QCDR. (3) Care coordination, such as timely communication of test results, timely exchange of clinical information to patients or other clinicians, and use of remote monitoring or telehealth. (4) Beneficiary engagement, such as the establishment of care plans for individuals with complex care needs, beneficiary self-management assessment and training, and using shared decision making mechanisms. (5) Patient safety and practice assessment, such as through the use of clinical or surgical checklists and practice assessments related to maintaining certification. (6) Participation in an APM. (7) Achieving health equity, such as for MIPS eligible clinicians that achieve high quality for underserved populations, including persons with behavioral health conditions, racial and ethnic minorities, sexual and gender minorities, people with disabilities, people living in rural areas, and people in geographic HPSAs. (8) Emergency preparedness and response, such as measuring MIPS eligible clinician participation in the Medical Reserve Corps, measuring registration in the Emergency System for Advance Registration of Volunteer Health Professionals, measuring relevant reserve and active duty uniformed services MIPS eligible clinician activities, and measuring MIPS eligible clinician volunteer participation in domestic or international humanitarian medical relief work. (9) Integrated behavioral and mental health, such as measuring or evaluating such practices as: Co-location of behavioral health and primary care services; shared/integrated behavioral health and primary care records; cross training of MIPS eligible clinicians, and integrating behavioral health with primary care to address substance use disorders or other behavioral health conditions, as well as integrating mental health with primary care. ■ 32. Section 414.1360 is amended by revising paragraph (a)(1) to read as follows: § 414.1360 Data submission criteria for the improvement activities performance category. (a) * * * (1) Via direct, login and upload, and login and attest. For the applicable performance period, submit a yes response for each improvement activity that is performed for at least a VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 continuous 90-day period during the applicable performance period. * * * * * § 414.1365 [Removed] 33. Section 414.1365 is removed. ■ 34. Section 414.1370 is amended by revising paragraphs (b)(3), (f)(2), (g)(4), (h)(4) introductory heading, (h)(5)(i)(A) and (B), and (h)(5)(ii) introductory text. The revisions read as follows: ■ § 414.1370 MIPS. APM scoring standard under * * * * * (b) * * * (3) The APM bases payment on quality measures and cost/utilization; and * * * * * (f) * * * (2) MIPS eligible clinicians who participate in a group or have elected to participate in a virtual group and who are also on a MIPS APM Participation List will be included in the assessment under MIPS for purposes of producing a group or virtual group score and under the APM scoring standard for purposes of producing an APM Entity score. The MIPS payment adjustment for these eligible clinicians is based solely on their APM Entity score; if the APM Entity group is exempt from MIPS all eligible clinicians within that APM Entity group are also exempt from MIPS. (g) * * * (4) Promoting Interoperability. (i) For the 2019 and 2020 MIPS payment years, each Shared Savings Program ACO participant TIN must report data on the Promoting Interoperability performance category separately from the ACO, as specified in § 414.1375(b)(2). The ACO participant TIN scores are weighted according to the number of MIPS eligible clinicians in each TIN as a proportion of the total number of MIPS eligible clinicians in the APM Entity group, and then aggregated to determine an APM Entity score for the ACI performance category. (ii) For the 2019 and 2020 MIPS payment years, for APM Entities in MIPS APMs other than the Shared Savings Program, CMS uses one score for each MIPS eligible clinician in the APM Entity group to derive a single average APM Entity score for the Promoting Interoperability performance category. Beginning with the 2021 MIPS payment year, for APM Entities in MIPS APMs including the Shared Savings Program, CMS uses one score for each MIPS eligible clinician in the APM Entity group to derive a single average APM Entity score for the Promoting Interoperability performance category. PO 00000 Frm 00246 Fmt 4701 Sfmt 4700 The score for each MIPS eligible clinician is the higher of either: (A) A group score based on the measure data for the Promoting Interoperability performance category reported by a TIN for the MIPS eligible clinician according to MIPS submission and reporting requirements for groups; or (B) An individual score based on the measure data for the Promoting Interoperability performance category reported by the MIPS eligible clinician according to MIPS submission and reporting requirements for individuals. (iii) In the event that a MIPS eligible clinician participating in a MIPS APM receives an exception from the Promoting Interoperability performance category reporting requirements, such eligible clinician will be assigned a null score when CMS calculates the APM Entity’s Promoting Interoperability performance category score under the APM scoring standard. (A) If all MIPS eligible clinicians in an APM Entity have been excepted from reporting the Promoting Interoperability performance category, the performance category weight will be reweighted to zero for the APM Entity for that MIPS performance period. (B) [Reserved] (h) * * * (4) Promoting Interoperability. * * * (5) * * * (i) * * * (A) In 2017, the improvement activities performance category is reweighted to 25 percent and the Promoting Interoperability performance category is reweighted to 75 percent; and (B) Beginning in 2018, the Promoting Interoperability performance category is reweighted to 75 percent and the improvement activities performance category is reweighted to 25 percent. (ii) If CMS reweights the Promoting Interoperability performance category to zero percent: * * * * * ■ 35. Section 414.1375 is amended by revising the section heading, paragraphs (a), (b) introductory text, and (b)(2) to read as follows: § 414.1375 Promoting Interoperability (PI) performance category. (a) Final score. Unless a different scoring weight is assigned by CMS under sections 1848(o)(2)(D), 1848(q)(5)(E)(ii), or 1848(q)(5)(F) of the Act, performance in the Promoting Interoperability performance category comprises 25 percent of a MIPS eligible clinician’s final score for each MIPS payment year. E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations (b) Reporting for the Promoting Interoperability performance category. To earn a performance category score for the Promoting Interoperability performance category for inclusion in the final score, a MIPS eligible clinician must: * * * * * (2) Report MIPS—Promoting Interoperability objectives and measures. Report on the objectives and associated measures as specified by CMS for the Promoting Interoperability performance category for the performance period as follows: (i) For the 2019 and 2020 MIPS payment years: For each base score measure, as applicable, report the numerator (of at least one) and denominator, or yes/no statement, or claim an exclusion for each measure that includes an option for an exclusion; and (ii) For the 2021 and 2022 MIPS payment years: (A) Report that the MIPS eligible clinician completed the actions included in the Security Risk Analysis measure during the year in which the performance period occurs; and (B) For each required measure, as applicable, report the numerator (of at least one) and denominator, or yes/no statement, or an exclusion for each measure that includes an option for an exclusion. * * * * * ■ 36. Section 414.1380 is revised to read as follows: amozie on DSK3GDR082PROD with RULES3 § 414.1380 Scoring. (a) General. MIPS eligible clinicians are scored under MIPS based on their performance on measures and activities in four performance categories. MIPS eligible clinicians are scored against performance standards for each performance category and receive a final score, composed of their performance category scores, and calculated according to the final score methodology. (1) Performance standards. (i) For the quality performance category, measures are scored between zero and 10 measure achievement points. Performance is measured against benchmarks. Measure bonus points are available for submitting high-priority measures, submitting measures using end-to-end electronic reporting, and in small practices that submit data on at least 1 quality measure. Beginning with the 2020 MIPS payment year, improvement scoring is available in the quality performance category. (ii) For the cost performance category, measures are scored between 1 and 10 VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 points. Performance is measured against a benchmark. Starting with the 2024 MIPS payment year, improvement scoring is available in the cost performance category. (iii) For the improvement activities performance category, each improvement activity is assigned a certain number of points. The points for all submitted activities are summed and scored against a total potential performance category score of 40 points. (iv) For the Promoting Interoperability performance category, each measure is scored against a maximum number of points. The points for all submitted measures are summed and scored against a total potential performance category score of 100 points. (2) [Reserved] (b) Performance categories. MIPS eligible clinicians are scored under MIPS in four performance categories. (1) Quality performance category. (i) Measure achievement points. For the 2019, 2020, and 2021 MIPS payment years, MIPS eligible clinicians receive between 3 and 10 measure achievement points (including partial points) for each measure required under § 414.1335 on which data is submitted in accordance with § 414.1325 that has a benchmark at paragraph (b)(1)(ii) of this section, meets the case minimum requirement at paragraph (b)(1)(iii) of this section, and meets the data completeness requirement at § 414.1340. The number of measure achievement points received for each such measure is determined based on the applicable benchmark decile category and the percentile distribution. MIPS eligible clinicians receive zero measure achievement points for each measure required under § 414.1335 on which no data is submitted in accordance with § 414.1325. MIPS eligible clinicians that submit data in accordance with § 414.1325 on a greater number of measures than required under § 414.1335 are scored only on the required measures with the greatest number of measure achievement points. Beginning with the 2021 MIPS payment year, MIPS eligible clinicians that submit data in accordance with § 414.1325 on a single measure via multiple collection types are scored only on the data submission with the greatest number of measure achievement points. (A) Lack of benchmark or case minimum. (1) Except as provided in paragraph (b)(1)(i)(A)(2) of this section, for the 2019, 2020, and 2021 MIPS payment years, MIPS eligible clinicians receive 3 measure achievement points for each submitted measure that meets the data completeness requirement, but PO 00000 Frm 00247 Fmt 4701 Sfmt 4700 60081 does not have a benchmark or meet the case minimum requirement. (2) The following measures are excluded from a MIPS eligible clinician’s total measure achievement points and total available measure achievement points: (i) Each submitted CMS Web Interface-based measure that meets the data completeness requirement, but does not have a benchmark or meet the case minimum requirement, or is redesignated as pay-for-reporting for all Shared Savings Program accountable care organizations by the Shared Savings Program; and (ii) Each administrative claims-based measure that does not have a benchmark or meet the case minimum requirement. (B) Lack of complete data. (1) Except as provided in paragraph (b)(1)(i)(B)(2) of this section, for each submitted measure that does not meet the data completeness requirement: (i) For the 2019 MIPS payment year, MIPS eligible clinicians receive 3 measure achievement points; (ii) For the 2020 and 2021 MIPS payment years, MIPS eligible clinicians other than small practices receive 1 measure achievement point, and small practices receive 3 measure achievement points; and (iii) Beginning with the 2022 MIPS payment year, MIPS eligible clinicians other than small practices receive zero measure achievement points, and small practices receive 3 measure achievement points. (2) MIPS eligible clinicians receive zero measure achievement points for each submitted CMS Web Interfacebased measure that does not meet the data completeness requirement. (ii) Benchmarks. Benchmarks will be based on collection type, from all available sources, including MIPS eligible clinicians and APMs, to the extent feasible, during the applicable baseline or performance period. (A) Each benchmark must have a minimum of 20 individual clinicians or groups who reported the measure meeting the case minimum requirement at paragraph (b)(1)(iii) of this section and the data completeness requirement at § 414.1340 and having a performance rate that is greater than zero. (B) CMS Web Interface collection type uses benchmarks from the corresponding reporting year of the Shared Savings Program. (iii) Minimum case requirements. Except for the all-cause hospital readmission measure, the minimum case requirement is 20 cases. For the allcause hospital readmission measure, the minimum case requirement is 200 cases. E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 60082 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations (iv) Topped out measures. CMS will identify topped out measures in the benchmarks published for each Quality Payment Program year. (A) For the 2020 MIPS payment year, each topped out measure specified by CMS through rulemaking receives no more than 7 measure achievement points, provided that the benchmark for the applicable collection type is identified as topped out in the benchmarks published for the 2018 MIPS performance period. (B) Beginning with the 2021 MIPS payment year, each measure (except for measures in the CMS Web Interface) for which the benchmark for the applicable collection type is identified as topped out for 2 or more consecutive years receives no more than 7 measure achievement points in the second consecutive year it is identified as topped out, and beyond. (v) Measure bonus points. MIPS eligible clinicians receive measure bonus points for the following measures, except as otherwise required under § 414.1335, regardless of whether the measure is included in the MIPS eligible clinician’s total measure achievement points. (A) High priority measures. Subject to paragraph (b)(1)(v)(A)(1) of this section, MIPS eligible clinicians receive 2 measure bonus points for each outcome and patient experience measure and 1 measure bonus point for each other high priority measure. Beginning with the 2021 MIPS payment year, MIPS eligible clinicians do not receive such measure bonus points for CMS Web Interface measures. (1) Limitations. (i) Each high priority measure must have a benchmark at paragraph (b)(1)(ii) of this section, meet the case minimum requirement at (b)(1)(iii) of this section, meet the data completeness requirement at § 414.1340, and have a performance rate that is greater than zero. (ii) For the 2019, 2020, and 2021 MIPS payment years, the total measure bonus points for high priority measures cannot exceed 10 percent of the total available measure achievement points. (iii) Beginning with the 2021 MIPS payment year, MIPS eligible clinicians that collect data in accordance with § 414.1325 on a single measure via multiple collection types receive measure bonus points only once. (B) End-to-end electronic reporting. Subject to paragraph (b)(1)(v)(B)(1) of this section, MIPS eligible clinicians receive 1 measure bonus point for each measure (except claims-based measures) submitted with end-to-end electronic reporting for a quality measure under VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 certain criteria determined by the Secretary. (1) Limitations. (i) For the 2019, 2020, and 2021 MIPS payment years, the total measure bonus points for measures submitted with end-to-end electronic reporting cannot exceed 10 percent of the total available measure achievement points. (ii) Beginning with the 2021 MIPS payment year, MIPS eligible clinicians that collect data in accordance with § 414.1325 on a single measure via multiple collection types receive measure bonus points only once. (C) Small practices. Beginning with the 2021 MIPS payment year, MIPS eligible clinicians in small practices receive 6 measure bonus points if they submit data to MIPS on at least 1 quality measure. (vi) Improvement scoring. Improvement scoring is available to MIPS eligible clinicians that demonstrate improvement in performance in the current MIPS performance period compared to performance in the performance period immediately prior to the current MIPS performance period based on measure achievement points. (A) Improvement scoring is available when the data sufficiency standard is met, which means when data are available and a MIPS eligible clinician has a quality performance category achievement percent score for the previous performance period and the current performance period. (1) Data must be comparable to meet the requirement of data sufficiency which means that the quality performance category achievement percent score is available for the current performance period and the previous performance period and quality performance category achievement percent scores can be compared. (2) Quality performance category achievement percent scores are comparable when submissions are received from the same identifier for two consecutive performance periods. (3) If the identifier is not the same for 2 consecutive performance periods, then for individual submissions, the comparable quality performance category achievement percent score is the highest available quality performance category achievement percent score associated with the final score from the prior performance period that will be used for payment for the individual. For group, virtual group, and APM Entity submissions, the comparable quality performance category achievement percent score is the average of the quality performance category achievement percent score PO 00000 Frm 00248 Fmt 4701 Sfmt 4700 associated with the final score from the prior performance period that will be used for payment for each of the individuals in the group. (4) Improvement scoring is not available for clinicians who were scored under facility-based measurement in the performance period immediately prior to the current MIPS performance period. (B) The improvement percent score may not total more than 10 percentage points. (C) The improvement percent score is assessed at the performance category level for the quality performance category and included in the calculation of the quality performance category percent score as described in paragraph (b)(1)(vii) of this section. (1) The improvement percent score is awarded based on the rate of increase in the quality performance category achievement percent score of MIPS eligible clinicians from the previous performance period to the current performance period. (2) An improvement percent score is calculated by dividing the increase in the quality performance category achievement percent score from the prior performance period to the current performance period by the prior performance period quality performance category achievement percent score multiplied by 10 percent. (3) An improvement percent score cannot be lower than zero percentage points. (4) For the 2020 and 2021 MIPS payment year, we will assume a quality performance category achievement percent score of 30 percent if a MIPS eligible clinician earned a quality performance category score less than or equal to 30 percent in the previous year. (5) The improvement percent score is zero if the MIPS eligible clinician did not fully participate in the quality performance category for the current performance period. (D) For the purpose of improvement scoring methodology, the term ‘‘quality performance category achievement percent score’’ means the total measure achievement points divided by the total available measure achievement points, without consideration of measure bonus points or improvement percent score. (E) For the purpose of improvement scoring methodology, the term ‘‘improvement percent score’’ means the score that represents improvement for the purposes of calculating the quality performance category percent score as described in paragraph (b)(1)(vii) of this section. (F) For the purpose of improvement scoring methodology, the term ‘‘fully participate’’ means the MIPS eligible E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations clinician met all requirements in §§ 414.1335 and 414.1340. (vii) Quality performance category score. A MIPS eligible clinician’s quality performance category percent score is the sum of all the measure achievement points assigned for the measures required for the quality performance category criteria plus the measure bonus points in paragraph (b)(1)(v) of this section. The sum is divided by the sum of total available measure achievement points. The improvement percent score in paragraph (b)(1)(vi) of this section is added to that result. The quality performance category percent score cannot exceed 100 percentage points. (A) Beginning with the 2021 MIPS payment year, for each measure that a MIPS eligible clinician submits that is significantly impacted by clinical guideline changes or other changes that CMS believes may result in patient harm or misleading results, the total available measure achievement points are reduced by 10 points. (B) Beginning with the 2021 MIPS payment year, for groups that submit 5 or fewer measures and register for the CAHPS for MIPS survey but do not meet the minimum beneficiary sampling requirements, the total available measure achievement points are reduced by 10 points. (viii) ICD–10 updates. Beginning with the 2018 MIPS performance period, measures significantly impacted by ICD–10 updates, as determined by CMS, will be assessed based only on the first 9 months of the 12-month performance period. For purposes of this paragraph (b)(1)(viii), CMS will make a determination as to whether a measure is significantly impacted by ICD–10 coding changes during the performance period. CMS will publish on the CMS website which measures require a 9month assessment process by October 1st of the performance period if technically feasible, but by no later than the beginning of the data submission period at § 414.1325(f)(1). (2) Cost performance category. For each cost measure attributed to a MIPS eligible clinician, the clinician receives one to ten achievement points based on the clinician’s performance on the measure during the performance period compared to the measure’s benchmark. Achievement points are awarded based on which benchmark decile range the MIPS eligible clinician’s performance on the measure is between. CMS assigns partial points based on the percentile distribution. (i) Cost measure benchmarks are determined by CMS based on cost measure performance during the VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 performance period. At least 20 MIPS eligible clinicians or groups must meet the minimum case volume specified under § 414.1350(c) for a cost measure in order for a benchmark to be determined for the measure. If a benchmark is not determined for a cost measure, the measure will not be scored. (ii) A MIPS eligible clinician must meet the minimum case volume specified under § 414.1350(c) to be scored on a cost measure. (iii) The cost performance category percent score is the sum of the following, not to exceed 100 percent: (A) The total number of achievement points earned by the MIPS eligible clinician divided by the total number of available achievement points; and (B) The cost improvement score, as determined under paragraph (b)(2)(iv) of this section. (iv) The cost improvement score is determined for a MIPS eligible clinician that demonstrates improvement in performance in the current MIPS performance period compared to their performance in the immediately preceding MIPS performance period. (A) The cost improvement score is determined at the measure level for the cost performance category. (B) The cost improvement score is calculated only when data sufficient to measure improvement is available. Sufficient data is available when a MIPS eligible clinician or group participates in MIPS using the same identifier in 2 consecutive performance periods and is scored on the same cost measure(s) for 2 consecutive performance periods. If the cost improvement score cannot be calculated because sufficient data is not available, then the cost improvement score is zero. (C) The cost improvement score is determined by comparing the number of measures with a statistically significant change (improvement or decline) in performance; a change is determined to be significant based on application of a t-test. The number of cost measures with a significant decline is subtracted from the number of cost measures with a significant improvement, with the result divided by the number of cost measures for which the MIPS eligible clinician or group was scored for 2 consecutive performance periods. The resulting fraction is then multiplied by the maximum cost improvement score. (D) The cost improvement score cannot be lower than zero percentage points. (E) The maximum cost improvement score for the 2020, 2021, 2022, and 2023 MIPS payment years is zero percentage points. PO 00000 Frm 00249 Fmt 4701 Sfmt 4700 60083 (v) A cost performance category percent score is not calculated if a MIPS eligible clinician or group is not attributed any cost measures for the performance period because the clinician or group has not met the minimum case volume specified by CMS for any of the cost measures or a benchmark has not been created for any of the cost measures that would otherwise be attributed to the clinician or group. (3) Improvement activities performance category. Subject to paragraphs (b)(3)(i) and (ii) of this section, the improvement activities performance category score equals the total points for all submitted improvement activities divided by 40 points, multiplied by 100 percent. MIPS eligible clinicians (except for nonpatient facing MIPS eligible clinicians, small practices, and practices located in rural areas and geographic HPSAs) receive 10 points for each mediumweighted improvement activity and 20 points for each high-weighted improvement activity required under § 414.1360 on which data is submitted in accordance with § 414.1325. Nonpatient facing MIPS eligible clinicians, small practices, and practices located in rural areas and geographic HPSAs receive 20 points for each mediumweighted improvement activity and 40 points for each high-weighted improvement activity required under § 414.1360 on which data is submitted in accordance with § 414.1325. (i) For MIPS eligible clinicians participating in APMs, the improvement activities performance category score is at least 50 percent. (ii) For MIPS eligible clinicians in a practice that is certified or recognized as a patient-centered medical home or comparable specialty practice, as determined by the Secretary, the improvement activities performance category score is 100 percent. For the 2019 MIPS payment year, at least one practice site within a group’s TIN must be certified or recognized as a patientcentered medical home or comparable specialty practice. For the 2020 MIPS payment year and future years, at least 50 percent of the practice sites within a group’s TIN must be recognized as a patient-centered medical home or comparable specialty practice. MIPS eligible clinicians that wish to claim this status for purposes of receiving full credit in the improvement activities performance category must attest to their status as a patient-centered medical home or comparable specialty practice in order to receive this credit. A practice is certified or recognized as E:\FR\FM\23NOR3.SGM 23NOR3 60084 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations a patient-centered medical home if it meets any of the following criteria: (A) The practice has received accreditation from one of four accreditation organizations that are nationally recognized; (1) The Accreditation Association for Ambulatory Health Care; (2) The National Committee for Quality Assurance (NCQA); (3) The Joint Commission; or (4) The Utilization Review Accreditation Commission (URAC). (B) The practice is participating in a Medicaid Medical Home Model or Medical Home Model. (C) The practice is a comparable specialty practice that has received the NCQA Patient-Centered Specialty Recognition. (D) The practice has received accreditation from other certifying bodies that have certified a large number of medical organizations and meet national guidelines, as determined by the Secretary. The Secretary must determine that these certifying bodies must have 500 or more certified member practices, and require practices to include the following: (1) Have a personal physician/ clinician in a team-based practice. (2) Have a whole-person orientation. (3) Provide coordination or integrated care. (4) Focus on quality and safety. (5) Provide enhanced access. (4) Promoting Interoperability performance category. (i) For the 2019 and 2020 MIPS payment years, a MIPS eligible clinician’s Promoting Interoperability performance category score equals the sum of the base score, performance score, and any applicable bonus scores, not to exceed 100 percentage points. A MIPS eligible clinician cannot earn a performance score or bonus score unless they have earned a base score. (A) A MIPS eligible clinician earns a base score by reporting for each base score measure, as applicable: The numerator (of at least one) and denominator, or a yes/no statement, or an exclusion. (B) A MIPS eligible clinician earns a performance score by reporting on the performance score measures specified by CMS. A MIPS eligible clinician may earn up to 10 or 20 percentage points as specified by CMS for each performance score measure reported. (C) A MIPS eligible clinician may earn the following bonus scores: (1) A bonus score of 5 percentage points for reporting to one or more additional public health agencies or clinical data registries. (2) A bonus score of 10 percentage points for attesting to completing one or more improvement activities specified by CMS using CEHRT. (3) For the 2020 MIPS payment year, a bonus score of 10 percentage points for submitting data for the measures for the base score and the performance score generated solely from CEHRT as defined in § 414.1305 for 2019 and subsequent years. (ii) For the 2021 and 2022 MIPS payment years, a MIPS eligible clinician’s Promoting Interoperability performance category score equals the sum of the scores for each of the six required measures and any applicable bonus scores, not to exceed 100 points. (A) A MIPS eligible clinician earns a score for each measure by reporting, as applicable: the numerator (of at least one) and denominator, or a yes/no statement. If an exclusion is reported for a measure, the points available for that measure are redistributed to another measure(s). (B) Each required measure is worth 10, 20, or 40 points, as specified by CMS. (C) Each optional measure is worth five bonus points. (c) Final score calculation. Each MIPS eligible clinician receives a final score of 0 to 100 points for a performance period for a MIPS payment year calculated as follows. If a MIPS eligible clinician is scored on fewer than 2 performance categories, he or she receives a final score equal to the performance threshold. amozie on DSK3GDR082PROD with RULES3 For the 2019 MIPS payment year: Final score = [(quality performance category percent score × quality performance category weight) + (cost performance category percent score × cost performance category weight) + (improvement activities performance category score × improvement activities performance category weight) + (Promoting Interoperability performance category score × Promoting Interoperability performance category weight)], not to exceed 100 points. For the 2020 MIPS payment year: Final score = [(quality performance category percent score × quality performance category weight) + (cost performance category percent score × cost performance category weight) + (improvement activities performance category score × improvement activities performance category weight) + (Promoting Interoperability performance category score × Promoting Interoperability performance category weight)] × 100 + [the complex patient bonus + the small practice bonus], not to exceed 100 points. Beginning with the 2021 MIPS payment year: Final score = [(quality performance category percent score × quality performance category weight) + (cost performance category percent score × cost performance category weight) + (improvement activities performance category score × improvement activities performance category weight) + (Promoting Interoperability performance category score × Promoting Interoperability performance category weight)] × 100 + the complex patient bonus, not to exceed 100 points. (1) Performance category weights. The weights of the performance categories in the final score are as follows, unless a different scoring weight is assigned under paragraph (c)(2) of this section: (i) Quality performance category weight is defined under § 414.1330(b). (ii) Cost performance category weight is defined under § 414.1350(d). (iii) Improvement activities performance category weight is defined under § 414.1355(b). (iv) Promoting Interoperability performance category weight is defined under § 414.1375(a). VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 (2) Reweighting the performance categories. (i) In accordance with paragraph (c)(2)(ii) of this section, a scoring weight different from the weights specified in paragraph (c)(1) of this section will be assigned to a performance category, and its weight as specified in paragraph (c)(1) of this section will be redistributed to another performance category or categories, in the following circumstances: (A) CMS determines based on the following circumstances that there are not sufficient measures and activities PO 00000 Frm 00250 Fmt 4701 Sfmt 4700 applicable and available under section 1848(q)(5)(F) of the Act. (1) For the quality performance category, CMS cannot calculate a score for the MIPS eligible clinician because there is not at least one quality measure applicable and available to the clinician. (2) For the cost performance category, CMS cannot reliably calculate a score for the cost measures that adequately captures and reflects the performance of the MIPS eligible clinician. (3) Beginning with the 2021 MIPS payment year, for the quality, cost, improvement activities, and Promoting E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations amozie on DSK3GDR082PROD with RULES3 Interoperability performance categories, the MIPS eligible clinician joins an existing practice during the final 3 months of the performance period year that is not participating in MIPS as a group or joins a practice that is newly formed during the final 3 months of the performance period year. (4) For the Promoting Interoperability performance category beginning with the 2021 MIPS payment year, the MIPS eligible clinician is a physical therapist, occupational therapist, clinical psychologist, qualified audiologist, qualified speech-language pathologist, or a registered dietitian or nutrition professional. In the event that a MIPS eligible clinician submits data for the Promoting Interoperability performance category, the scoring weight specified in paragraph (c)(1) of this section will be applied and its weight will not be redistributed. (5) For the Promoting Interoperability performance category for the 2019, 2020, and 2021 MIPS payment years, the MIPS eligible clinician is a nurse practitioner, physician assistant, clinical nurse specialist, or certified registered nurse anesthetist. In the event that a MIPS eligible clinician submits data for the Promoting Interoperability performance category, the scoring weight specified in paragraph (c)(1) of this section will be applied and its weight will not be redistributed. (6) Beginning with the 2020 MIPS payment year, for the quality, cost, and improvement activities performance categories, the MIPS eligible clinician demonstrates through an application submitted to CMS that they were subject to extreme and uncontrollable circumstances that prevented the clinician from collecting information that the clinician would submit for a performance category or submitting information that would be used to score a performance category for an extended period of time. Beginning with the 2021 MIPS payment year, in the event that a MIPS eligible clinician submits data for the quality, cost, or improvement activities performance categories, the scoring weight specified in paragraph (c)(1) of this section will be applied and its weight will not be redistributed. (7) For the 2019 MIPS payment year, for the quality and improvement activities performance categories, the MIPS eligible clinician was located in an area affected by extreme and uncontrollable circumstances as identified by CMS. In the event that a MIPS eligible clinician submits data for a performance category, the scoring weight specified in paragraph (c)(1) of this section will be applied and its weight will not be redistributed. (8) Beginning with the 2020 MIPS payment year, for the quality, cost, and improvement activities performance categories, the MIPS eligible clinician was located in an area affected by extreme and uncontrollable circumstances as identified by CMS. In the event that a MIPS eligible clinician submits data for the quality or improvement activities performance categories, the scoring weight specified in paragraph (c)(1) of this section will be applied and its weight will not be redistributed. (B) Under section 1848(q)(5)(E)(ii) of the Act, CMS estimates that the proportion of MIPS eligible clinicians who are physicians as defined in section 1861(r) of the Act and earn a Promoting Interoperability performance category score of at least 75 percent is 75 percent or greater. The estimation is based on data from the performance period that occurs four years before the MIPS payment year and does not include physicians for whom the Promoting Interoperability performance category is weighted at zero percent. (C) Under section 1848(o)(2)(D) of the Act, a significant hardship exception or other type of exception is granted to a MIPS eligible clinician based on the following circumstances for the Promoting Interoperability performance category. In the event that a MIPS eligible clinician submits data for the Promoting Interoperability performance category, the scoring weight specified in paragraph (c)(1) of this section will be applied and its weight will not be redistributed. (1) The MIPS eligible clinician demonstrates through an application submitted to CMS that they lacked sufficient internet access during the performance period, and insurmountable barriers prevented the clinician from obtaining sufficient internet access. Performance category (%) Quality ............................................................................................................................................... Cost ................................................................................................................................................... Improvement Activities ...................................................................................................................... VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00251 Fmt 4701 Sfmt 4700 60085 (2) The MIPS eligible clinician demonstrates through an application submitted to CMS that they were subject to extreme and uncontrollable circumstances that caused their CEHRT to be unavailable. (3) The MIPS eligible clinician was located in an area affected by extreme and uncontrollable circumstances as identified by CMS. (4) The MIPS eligible clinician demonstrates through an application submitted to CMS that 50 percent or more of their outpatient encounters occurred in practice locations where they had no control over the availability of CEHRT. (5) The MIPS eligible clinician is a non-patient facing MIPS eligible clinician as defined in § 414.1305. (6) The MIPS eligible clinician is a hospital-based MIPS eligible clinician as defined in § 414.1305. (7) The MIPS eligible clinician is an ASC-based MIPS eligible clinician as defined in § 414.1305. (8) Beginning with the 2020 MIPS payment year, the MIPS eligible clinician demonstrates through an application submitted to CMS that their CEHRT was decertified either during the performance period for the MIPS payment year or during the calendar year preceding the performance period for the MIPS payment year, and the MIPS eligible clinician made a good faith effort to adopt and implement another CEHRT in advance of the performance period. In no case may a MIPS eligible clinician be granted this exception for more than 5 years. (9) Beginning with the 2020 MIPS payment year, the MIPS eligible clinician demonstrates through an application submitted to CMS that they are in a small practice as defined in § 414.1305, and overwhelming barriers prevent them from complying with the requirements for the Promoting Interoperability performance category. (ii) A scoring weight different from the weights specified in paragraph (c)(1) of this section will be assigned to a performance category, and its weight as specified in paragraph (c)(1) of this section will be redistributed to another performance category or categories, as follows: (A) For the 2019 MIPS payment year: Weighting for the 2019 MIPS payment year (%) Reweight scenario if no promoting interoperability performance category score (%) Reweight scenario if no quality performance category percent score (%) Reweight scenario if no improvement activities performance category score (%) 60 0 15 85 0 15 0 0 50 75 0 0 E:\FR\FM\23NOR3.SGM 23NOR3 60086 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations Performance category (%) Weighting for the 2019 MIPS payment year (%) Reweight scenario if no promoting interoperability performance category score (%) Reweight scenario if no quality performance category percent score (%) Reweight scenario if no improvement activities performance category score (%) 25 0 50 25 Promoting Interoperability ................................................................................................................. (B) For the 2020 MIPS payment year: Quality (%) Reweighting scenario No Reweighting Needed: —Scores for all four performance categories .......................................... Reweight One Performance Category: —No Cost ................................................................................................. —No Promoting Interoperability ............................................................... —No Quality ............................................................................................. —No Improvement Activities .................................................................... Reweight Two Performance Categories: —No Cost and no Promoting Interoperability .......................................... —No Cost and no Quality ........................................................................ —No Cost and no Improvement Activities ............................................... —No Promoting Interoperability and no Quality ....................................... —No Promoting Interoperability and no Improvement Activities ............. —No Quality and no Improvement Activities ........................................... Improvement activities (%) Cost (%) Promoting interoperability (%) 50 10 15 25 60 75 0 65 0 10 10 10 15 15 45 0 25 0 45 25 85 0 75 0 90 0 0 0 0 10 10 10 15 50 0 90 0 0 0 50 25 0 0 90 (C) For the 2021 MIPS payment year: Quality (%) Reweighting scenario amozie on DSK3GDR082PROD with RULES3 No Reweighting Needed: —Scores for all four performance categories .......................................... Reweight One Performance Category: —No Cost ................................................................................................. —No Promoting Interoperability ............................................................... —No Quality ............................................................................................. —No Improvement Activities .................................................................... Reweight Two Performance Categories: —No Cost and no Promoting Interoperability .......................................... —No Cost and no Quality ........................................................................ —No Cost and no Improvement Activities ............................................... —No Promoting Interoperability and no Quality ....................................... —No Promoting Interoperability and no Improvement Activities ............. —No Quality and no Improvement Activities ........................................... (iii) For MIPS eligible clinicians submitting data as a group or virtual group, in order for the Promoting Interoperability performance category to be reweighted in accordance with paragraph (c)(2)(ii) of this section, all of the MIPS eligible clinicians in the group must qualify for reweighting based on the circumstances described in paragraph (c)(2)(i) of this section. (3) Complex patient bonus. For the 2020 and 2021 MIPS payment years, provided that a MIPS eligible clinician, group, virtual group or APM entity submits data for at least one MIPS performance category for the applicable performance period for the MIPS payment year, a complex patient bonus VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 Frm 00252 Fmt 4701 Sfmt 4700 Promoting interoperability (%) 45 15 15 25 60 70 0 60 0 15 15 15 15 15 40 0 25 0 45 25 85 0 75 0 85 0 0 0 0 15 15 15 15 50 0 85 0 0 0 50 25 0 0 85 will be added to the final score for the MIPS payment year, as follows: (i) For MIPS eligible clinicians and groups, the complex patient bonus is calculated as follows: [The average HCC risk score assigned to beneficiaries (pursuant to the HCC risk adjustment model established by CMS pursuant to section 1853(a)(1) of the Act) seen by the MIPS eligible clinician or seen by clinicians in a group] + [the dual eligible ratio × 5]. (ii) For APM entities and virtual groups, the complex patient bonus is calculated as follows: [The beneficiary weighted average HCC risk score for all MIPS eligible clinicians, and if technically feasible, TINs for models and virtual groups which rely on PO 00000 Improvement activities (%) Cost (%) complete TIN participation within the APM entity or virtual group, respectively] + [the average dual eligible ratio for all MIPS eligible clinicians, and if technically feasible, TINs for models and virtual groups which rely on complete TIN participation, within the APM entity or virtual group, respectively, × 5]. (iii) The complex patient bonus cannot exceed 5.0. (4) Small practice bonus. A small practice bonus of 5 points will be added to the final score for the 2020 MIPS payment year for MIPS eligible clinicians, groups, virtual groups, and APM Entities that meet the definition of a small practice as defined at § 414.1305 and participate in MIPS by submitting E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations data on at least one performance category in the 2018 MIPS performance period. (d) Scoring for APM Entities. MIPS eligible clinicians in APM Entities that are subject to the APM scoring standard are scored using the methodology under § 414.1370. (e) Scoring for facility-based measurement. For the payment in 2021 MIPS payment year and subsequent years and subject to paragraph (e)(6)(vi) of this section, a MIPS eligible clinician or group will be scored under the quality and cost performance categories using the methodology described in this paragraph (e). (1) General. The facility-based measurement scoring standard is the MIPS scoring methodology applicable for MIPS eligible clinicians identified as meeting the requirements in paragraph (e)(2) of this section. (i) The measures used for facilitybased measurement are the measure set finalized for the fiscal year value-based purchasing program for which payment begins during the applicable MIPS performance period. (ii) Beginning with the 2021 MIPS payment year, the scoring methodology applicable for MIPS eligible clinicians scored with facility-based measurement is the Total Performance Score methodology adopted for the Hospital VBP Program, for the fiscal year for which payment begins during the applicable MIPS performance period. (2) Eligibility for facility-based measurement. MIPS eligible clinicians are eligible for facility-based measurement for a MIPS payment year if they are determined to be facilitybased as an individual clinician or as part of a group, as follows: (i) Facility-based individual determination. A MIPS eligible clinician is facility-based if the clinician meets all of the following criteria: (A) Furnishes 75 percent or more of his or her covered professional services in sites of service identified by the place of service codes used in the HIPAA standard transaction as an inpatient hospital, on-campus outpatient hospital, or emergency room setting based on claims for a 12-month segment beginning on October 1 of the calendar year 2 years prior to the applicable performance period and ending on September 30 of the calendar year preceding the performance period with a 30-day claims run out. (B) Furnishes at least 1 covered professional service in sites of service identified by the place of service codes used in the HIPAA standard transaction as an inpatient hospital, or emergency room setting. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 (C) Can be attributed, under the methodology specified in paragraph (e)(5) of this section, to a facility with a value-based purchasing score for the applicable period. (ii) Facility-based group determination. A facility-based group is a group in which 75 percent or more of its eligible clinician NPIs billing under the group’s TIN meet the requirements under paragraph (e)(2)(i) of this section. (3) [Reserved] (4) Data submission for facility-based measurement. There are no data submission requirements for individual clinicians to be scored under facilitybased measurement. A group must submit data in the improvement activities or Promoting Interoperability performance categories in order to be scored as a facility-based group. (5) Determination of applicable facility score. (i) A facility-based clinician is scored with facility-based measurement using the score derived from the value-based purchasing score for the facility at which the clinician provided services to the most Medicare beneficiaries during the period the claims are drawn from in paragraph (e)(2) of this section. If there is an equal number of Medicare beneficiaries treated at more than one facility, the value-based purchasing score for the highest scoring facility is used. (ii) A facility-based group is scored with facility-based measurement using the score derived from the value-based purchasing score for the facility at which the plurality of clinicians identified as facility-based would have had their score determined under paragraph (e)(5)(i) of this section. (6) MIPS performance category scoring under the facility-based measurement scoring standard—(i) Measures. The quality and cost measures are those adopted under the value-based purchasing program of the facility for the year described in paragraph (e)(1)(i) of this section. (ii) Benchmarks. The benchmarks are those adopted under the value-based purchasing program of the facility program for the year described in paragraph (e)(1) of this section. (iii) Performance period. The performance period for facility-based measurement is the performance period for the measures adopted under the value-based purchasing program of the facility program for the year described in paragraph (e)(1) of this section. (iv) Quality. The quality performance category percent score is established by determining the percentile performance of the facility in the value-based purchasing program for the specified year as described in paragraph (e)(1) of PO 00000 Frm 00253 Fmt 4701 Sfmt 4700 60087 this section and awarding a score associated with that same percentile performance in the MIPS quality performance category percent score for those MIPS-eligible clinicians who are not eligible to be scored using facilitybased measurement for the MIPS payment year. A clinician or group receiving a facility-based performance score will not earn improvement points based on prior performance in the MIPS quality performance category (v) Cost. The cost performance category percent score is established by determining the percentile performance of the facility in the value-based purchasing program for the specified year as described in paragraph (e)(1) of this section and awarding a score associated with that same percentile performance in the MIPS cost performance category percent score for those MIPS eligible clinicians who are not eligible to be scored using facilitybased measurement for the MIPS payment year. A clinician or group receiving a facility-based performance score will not earn improvement points based on prior performance in the MIPS cost category. (A) Other cost measures. MIPS eligible clinicians who are scored under facility-based measurement are not scored on cost measures described in paragraph (b)(2) of this section. (B) [Reserved] (vi) Use of score from facility-based measurement. The MIPS quality and cost performance category scores will be based on the facility-based measurement scoring methodology described in paragraph (e)(6) of this section unless a clinician or group receives a higher combined MIPS quality and cost performance category score through another MIPS submission. ■ 37. Section 414.1395 is amended by revising paragraphs (b) and (c) to read as follows: § 414.1395 Public reporting. * * * * * (b) Maintain existing public reporting standards. With the exception of data that must be mandatorily reported on Physician Compare, for each program year, CMS relies on established public reporting standards to guide the information available for inclusion on Physician Compare. The public reporting standards require data included on Physician Compare to be statistically valid, reliable, and accurate; comparable across collection types; and meet the reliability threshold. And, to be included on the public facing profile pages, the data must also resonate with website users, as determined by CMS. E:\FR\FM\23NOR3.SGM 23NOR3 60088 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations (c) First year measures. For each program year, CMS does not publicly report any first year measure for the first 2 years, meaning any measure in its first 2 years of use in the quality and cost performance categories. After the first 2 years, CMS reevaluates measures to determine when and if they are suitable for public reporting. * * * * * ■ 38. Section 414.1400 is revised to read as follows: amozie on DSK3GDR082PROD with RULES3 § 414.1400 Third party intermediaries. (a) General. (1) MIPS data may be submitted on behalf of a MIPS eligible clinician, group, or virtual group by any of the following third party intermediaries: (i) A QCDR; (ii) A qualified registry; (iii) A health IT vendor; or (iv) A CMS-approved survey vendor. (2) QCDRs, qualified registries, and health IT vendors may submit MIPS data for any of the following MIPS performance categories: (i) Quality, except for data on the CAHPS for MIPS survey; (ii) Improvement activities; or (iii) Promoting Interoperability, if the MIPS eligible clinician, group, or virtual group is using CEHRT. (3) CMS-approved survey vendors may submit data on the CAHPS for MIPS survey for the MIPS quality performance category. (4) To be approved as a third party intermediary, an entity must agree to meet the applicable requirements of this section, including, but not limited to, the following: (i) A third party intermediary’s principle place of business and retention of any data must be based in the U.S. (ii) If the data is derived from CEHRT, a QCDR, qualified registry, or health IT vendor must be able to indicate its data source. (iii) All data must be submitted in the form and manner specified by CMS. (iv) If the clinician chooses to opt-in in accordance with § 414.1310, the third party intermediary must be able to transmit that decision to CMS. (5) All data submitted to CMS by a third party intermediary on behalf of a MIPS eligible clinician, group or virtual group must be certified by the third party intermediary as true, accurate, and complete to the best of its knowledge. Such certification must be made in a form and manner and at such time as specified by CMS. (b) QCDR approval criteria—(1) QCDR self-nomination. For the 2020 and 2021 MIPS payment years, entities seeking to VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 qualify as a QCDR must self-nominate September 1 until November 1 of the CY preceding the applicable performance period. For the 2022 MIPS payment year and future years, entities seeking to qualify as a QCDR must self-nominate during a 60-day period during the CY preceding the applicable performance period (beginning no earlier than July 1 and ending no later than September 1). Entities seeking to qualify as a QCDR for a performance period must provide all information required by CMS at the time of self-nomination and must provide any additional information requested by CMS during the review process. For the 2021 MIPS payment year and future years, existing QCDRs that are in good standing may attest that certain aspects of their previous year’s approved selfnomination have not changed and will be used for the applicable performance period. (2) Establishment of a QCDR entity. (i) Beginning with the 2022 MIPS Payment Year, the QCDR must have at least 25 participants by January 1 of the year prior to the applicable performance period. (ii) If the entity uses an external organization for purposes of data collection, calculation, or transmission, it must have a signed, written agreement with the external organization that specifically details the responsibilities of the entity and the external organization. The written agreement must be effective as of September 1 of the year preceding the applicable performance period. (3) QCDR measures for the quality performance category. (i) For purposes of QCDRs submitting data for the MIPS quality performance category, CMS considers the following types of quality measures to be QCDR measures: (A) Measures that are not included in the MIPS final list of quality measures described in § 414.1330(a)(1) for the applicable MIPS payment year; and (B) Measures that are included in the MIPS final list of quality measures described in § 414.1330(a)(1) for the applicable MIPS payment year, but have undergone substantive changes, as determined by CMS. (ii) For the 2020 MIPS payment year and future years, an entity seeking to become a QCDR must submit specifications for each measure, activity, and objective that the entity intends to submit to for MIPS (including the information described in paragraphs (b)(3)(ii)(A) and (B) of this section) at the time of self-nomination. In addition, no later than 15 calendar days following CMS approval of any QCDR measure specifications, the entity must publicly post the measure specifications for each PO 00000 Frm 00254 Fmt 4701 Sfmt 4700 QCDR measure (including the CMSassigned QCDR measure ID) and provide CMS with a link to where this information is posted. (A) For QCDR measures, the entity must submit the measure specifications for each QCDR measure, including: Name/title of measures, NQF number (if NQF-endorsed), descriptions of the denominator, numerator, and when applicable, denominator exceptions, denominator exclusions, risk adjustment variables, and risk adjustment algorithms. (B) For MIPS quality measures, the entity must submit the MIPS measure IDs and specialty-specific measure sets, as applicable. (iii) A QCDR must include the CMSassigned QCDR measure ID when submitting data on any QCDR measure to CMS. (c) Qualified registry approval criteria—(1) Qualified registry selfnomination. For the 2020 and 2021 MIPS payment years, entities seeking to qualify as a qualified registry must selfnominate from September 1 until November 1 of the CY preceding the applicable performance period. For the 2022 MIPS payment year and future years, entities seeking to qualify as a qualified registry must self-nominate during a 60-day period during the CY preceding the applicable performance period (beginning no earlier than July 1 and ending no later than September 1). Entities seeking to qualify as a qualified registry for a performance period must provide all information required by CMS at the time of self-nomination and must provide any additional information requested by CMS during the review process. For the 2021 MIPS payment year and future years, existing qualified registries that are in good standing may attest that certain aspects of their previous year’s approved selfnomination have not changed and will be used for the applicable performance period. (2) Establishment of a qualified registry entity. Beginning with the 2022 MIPS Payment Year, the qualified registry must have at least 25 participants by January 1 of the year prior to the applicable performance period. (d) Health IT vendor approval criteria. Health IT vendors must meet the criteria specified at paragraph (a)(4) of this section. (e) CMS-approved survey vendor approval criteria. Entities seeking to be a CMS-approved survey vendor for any MIPS performance period must submit a survey vendor application to CMS in a form and manner specified by CMS for each MIPS performance period for E:\FR\FM\23NOR3.SGM 23NOR3 amozie on DSK3GDR082PROD with RULES3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations which it wishes to transmit such data. The application and any supplemental information requested by CMS must be submitted by deadlines specified by CMS. For an entity to be a CMSapproved survey vendor, it must meet the following criteria: (1) The entity must have sufficient experience, capability, and capacity to accurately report CAHPS data, including: (i) At least 3 years of experience administering mixed-mode surveys (that is, surveys that employ multiple modes to collect date), including mail survey administration followed by survey administration via Computer Assisted Telephone Interview (CATI); (ii) At least 3 years of experience administering surveys to a Medicare population; (iii) At least 3 years of experience administering CAHPS surveys within the past 5 years; (iv) Experience administering surveys in English and at least one other language for which a translation of the CAHPS for MIPS survey is available; (v) Use equipment, software, computer programs, systems, and facilities that can verify addresses and phone numbers of sampled beneficiaries, monitor interviewers, collect data via CATI, electronically administer the survey and schedule callbacks to beneficiaries at varying times of the day and week, track fielded surveys, assign final disposition codes to reflect the outcome of data collection of each sampled case, and track cases from mail surveys through telephone follow-up activities; and (vi) Employment of a program manager, information systems specialist, call center supervisor and mail center supervisor to administer the survey. (2) The entity has certified that it has the ability to maintain and transmit quality data in a manner that preserves the security and integrity of the data. (3) The entity has successfully completed, and has required its subcontractors to successfully complete, vendor training(s) administered by CMS or its contractors. (4) The entity has submitted a quality assurance plan and other materials relevant to survey administration, as determined by CMS, including cover letters, questionnaires and telephone scripts. (5) The entity has agreed to participate and cooperate, and has required its subcontractors to participate and cooperate, in all oversight activities related to survey administration conducted by CMS or its contractors. (6) The entity has sent an interim survey data file to CMS that establishes VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 the entity’s ability to accurately report CAHPS data. (f) Remedial action and termination of third party intermediaries. (1) If CMS determines that a third party intermediary has ceased to meet one or more of the applicable criteria for approval, or has submitted data that is inaccurate, unusable, or otherwise compromised, CMS may take one or more of the following remedial actions after providing written notice to the third party intermediary: (i) Require the third party intermediary to submit a corrective action plan (CAP) to CMS to address the identified deficiencies or data issue, including the actions it will take to prevent the deficiencies or data issues from recurring. The CAP must be submitted to CMS by a date specified by CMS. (ii) Publicly disclose the entity’s data error rate on the CMS website until the data error rate falls below 3 percent. (2) CMS may immediately or with advance notice terminate the ability of a third party intermediary to submit MIPS data on behalf of a MIPS eligible clinician, group, or virtual group for one or more of the following reasons: (i) CMS has grounds to impose remedial action; (ii) CMS has not received a CAP within the specified time period or the CAP is not accepted by CMS; or (iii) The third party intermediary fails to correct the deficiencies or data errors by the date specified by CMS. (3) For purposes of paragraph (f) of this section, CMS may determine that submitted data is inaccurate, unusable, or otherwise compromised if the submitted data: (i) Includes, without limitation, TIN/ NPI mismatches, formatting issues, calculation errors, or data audit discrepancies; and (ii) Affects more than 3 percent of the total number of MIPS eligible clinicians or group for which data was submitted by the third party intermediary. (g) Auditing of entities submitting MIPS data. Any third party intermediary must comply with the following procedures as a condition of its qualification and approval to participate in MIPS as a third party intermediary. (1) The entity must make available to CMS the contact information of each MIPS eligible clinician or group on behalf of whom it submits data. The contact information must include, at a minimum, the MIPS eligible clinician or group’s practice phone number, address, and, if available, email. (2) The entity must retain all data submitted to CMS for purposes of MIPS PO 00000 Frm 00255 Fmt 4701 Sfmt 4700 60089 for 6 years from the end of the MIPS performance period. (3) For the purposes of auditing, CMS may request any records or data retained for the purposes of MIPS for up to 6 years from the end of the MIPS performance period. ■ 39. Section 414.1405 is amended by— ■ a. Adding paragraphs (b)(6) and (d)(5); ■ b. Revising paragraph (e); and ■ c. Adding paragraph (f). The additions and revision read as follows: § 414.1405 Payment. * * * * * (b) * * * (6) The performance threshold for the 2021 MIPS payment year is 30 points. * * * * * (d) * * * (5) The additional performance threshold for the 2021 MIPS payment year is 75 points. (e) Application of adjustments to payments. Except as specified in paragraph (f) of this section, in the case of covered professional services (as defined in section 1848(k)(3)(A) of the Act) furnished by a MIPS eligible clinician during a MIPS payment year beginning with 2019, the amount otherwise paid under Part B with respect to such covered professional services and MIPS eligible clinician for such year, is multiplied by 1, plus the sum of the MIPS payment adjustment factor divided by 100, and as applicable, the additional MIPS payment adjustment factor divided by 100. (f) Exception to application of MIPS payment adjustment factors to modelspecific payments under section 1115A APMs. Effective for the 2019 MIPS payment year, the payment adjustment factors specified under paragraph (e) of this section are not applicable to payments that meet all of the following conditions: (1) Are made only to participants in a model tested under section 1115A of the Act; (2) Would otherwise be subject to the requirement to apply the MIPS payment adjustment factors if the payment is made with respect to a MIPS eligible clinician participating in a section 1115A model; and (3) Either have a specified payment amount or are paid according to a methodology for calculating a modelspecific payment that is applied in a consistent manner to all model participants, such that application of the MIPS payment adjustment factors would potentially interfere with CMS’s ability to effectively evaluate the impact of the APM. E:\FR\FM\23NOR3.SGM 23NOR3 60090 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 40. Section 414.1415 is amended, effective January 1, 2019, by revising paragraphs (a)(1)(i) and (ii), (b)(1), (c) introductory text, (c)(3)(i)(A), and (c)(6) to read as follows: ■ amozie on DSK3GDR082PROD with RULES3 § 414.1415 Advanced APM criteria. (a) * * * (1) * * * (i) Require at least 50 percent, or for QP Performance Periods beginning in 2019, 75 percent of eligible clinicians in each participating APM Entity group, or for APMs in which hospitals are the APM Entities, each hospital, to use CEHRT to document and communicate clinical care to their patients or health care providers; or (ii) For QP Performance Periods prior to 2019, for the Shared Savings Program, apply a penalty or reward to an APM Entity based on the degree of the use of CEHRT of the eligible clinicians in the APM Entity. (b) * * * (1) To be an Advanced APM, an APM must include quality measure performance as a factor when determining payment to participants for covered professional services under the terms of the APM. * * * * * (c) Financial risk. To be an Advanced APM, except as described in paragraph (c)(6) of this section, an APM must either meet the financial risk standard under paragraph (c)(1) or (2) of this section and the nominal amount standard under paragraph (c)(3) or (4) of this section or be an expanded Medical Home Model under section 1115A(c) of the Act. * * * * * (3) * * * (i) * * * (A) For QP Performance Periods beginning in 2017, through 2024, 8 percent of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities; or * * * * * (6) Capitation. A full capitation arrangement meets this Advanced APM criterion. For purposes of this part, a full capitation arrangement means a payment arrangement in which a per capita or otherwise predetermined payment is made under the APM for all items and services furnished to a population of beneficiaries during a fixed period of time, and no settlement is performed to reconcile or share losses incurred or savings earned by the APM Entity. Arrangements between CMS and Medicare Advantage Organizations under the Medicare Advantage program (42 U.S.C. 422) are not considered VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 capitation arrangements for purposes of this paragraph (c)(6). * * * * * ■ 41. Section 414.1415 is further amended (effective January 1, 2010) by revising paragraphs (b)(2) and (3) to read as follows: § 414.1415 Advanced APM criteria. * * * * * (b) * * * (2) At least one of the quality measures used in the payment arrangement as specified in paragraph (b)(1) of this section must: (i) For QP Performance Periods before January 1, 2020, have an evidence-based focus, be reliable and valid, and meet at least one of the following criteria: (A) Used in the MIPS quality performance category, as described in § 414.1330; (B) Endorsed by a consensus-based entity; (C) Developed under section 1848(s) of the Act; (D) Submitted in response to the MIPS Call for Quality Measures under section 1848(q)(2)(D)(ii) of the Act; or (E) Any other quality measures that CMS determines to have an evidencebased focus and to be reliable and valid; and (ii) For QP Performance Periods beginning on or after January1, 2020, be: (A) Finalized on the MIPS final list of measures, as described in § 414.1330; (B) Endorsed by a consensus-based entity; or (C) Determined by CMS to be evidenced-based, reliable, and valid. (3) In addition to the quality measure described under paragraph (b)(2) of this section, the quality measures upon which an Advanced APM bases the payment in paragraph (b)(1) of this section must include at least one additional measure that is an outcome measure unless CMS determines that there are no available or applicable outcome measures included in the MIPS final quality measures list for the Advanced APM’s first QP Performance Period. Beginning January 1, 2020, the included outcome measure must satisfy the criteria in paragraph (b)(2) of this section. * * * * * ■ 42. Section 414.1420 is amended effective January 1, 2019, by revising paragraphs (d) introductory text, (d)(3)(i), and (d)(7) to read as follows: § 414.1420 criteria. Other payer advanced APM * * * * * (d) Financial risk. To be an Other Payer Advanced APM, except as PO 00000 Frm 00256 Fmt 4701 Sfmt 4700 described in paragraph (d)(7) of this section, a payment arrangement must meet either the financial risk standard under paragraph (d)(1) or (2) of this section and the nominal amount standard under paragraph (d)(3) or (4) of this section, or be a Medicaid Medical Home Model with criteria comparable to an expanded Medical Home Model under section 1115A(c) of the Act. * * * * * (3) * * * (i) For QP Performance Periods 2019 through 2024, 8 percent of the total combined revenues from the payer to providers and other entities under the payment arrangement if financial risk is expressly defined in terms of revenue; or, 3 percent of the expected expenditures for which an APM Entity is responsible under the payment arrangement. * * * * * (7) Capitation. A full capitation arrangement meets this Other Payer Advanced APM criterion. For purposes of paragraph (d)(3) of this section, a full capitation arrangement means a payment arrangement in which a per capita or otherwise predetermined payment is made under the payment arrangement for all items and services furnished to a population of beneficiaries during a fixed period of time, and no settlement is performed for the purpose of reconciling or sharing losses incurred or savings earned by the participant. Arrangements made directly between CMS and Medicare Advantage Organizations under the Medicare Advantage program (42 U.S.C. 422) are not considered capitation arrangements for purposes of this paragraph (c)(7). * * * * * ■ 43. Section 414.1420 is further amended (effective January 1, 2020) by revising paragraphs (b), (c)(2) and (3) to read as follows: § 414.1420 criteria. Other payer advanced APM * * * * * (b) Use of CEHRT. To be an Other Payer Advanced APM, CEHRT must be used by at least 50 percent, or for QP Performance Periods on or after January 1, 2020, 75 percent of participants in each participating APM Entity group, or each hospital if hospitals are the APM Entities, in the other payer arrangement to document and communicate clinical care. (c) * * * (2) At least one of the quality measures used in the payment arrangement as specified in paragraph (c)(1) of this section must: E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations (i) For QP Performance Period before January 1, 2020, have an evidence-based focus, be reliable and valid, and meet at least one of the following criteria: (A) Used in the MIPS quality performance category, as described in § 414.1330; (B) Endorsed by a consensus-based entity; (C) Developed under section 1848(s) of the Act; (D) Submitted in response to the MIPS Call for Quality Measures under section 1848(q)(2)(D)(ii) of the Act; or (E) Any other quality measures that CMS determines to have an evidencebased focus and to be reliable and valid; and (ii) For QP Performance Periods beginning on or after January 1, 2020, be: (A) Finalized on the MIPS final list of measures, as described in § 414.1330; (B) Endorsed by a consensus-based entity; or (C) Determined by CMS to be evidenced-based, reliable, and valid. (3) To meet the quality measure use criterion under paragraph (c)(1) of this section, a payment arrangement must: (i) For QP Performance Periods before January 1, 2020, use an outcome measure if there is an applicable outcome measure on the MIPS quality measure list. This criterion also applies for payment arrangements determined to be Other Payer Advanced APMs on or before January 1, 2020, but only for the Other Payer Advanced APM determination made with respect to the arrangement for the CY 2020 QP Performance Period (regardless of whether that determination is a singleor multi-year determination). (ii) For QP Performance Periods on or after January 1, 2020, in addition to the quality measure described under paragraph (c)(2) of this section, use at least one additional measure that is an outcome measure and meets the criteria in paragraph (c)(2)(ii) of this section if there is such an applicable outcome measure on the MIPS quality measure list. * * * * * ■ 44. Section 414.1440 is amended by revising paragraphs (d)(1) through (3) to read as follows: amozie on DSK3GDR082PROD with RULES3 § 414.1440 Qualifying APM participant determination: All-payer combination option. * * * * * (d) * * * (1) CMS performs QP determinations following the QP Performance Period using payment amount and/or patient count information submitted from January 1 through each of the respective VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 QP determination dates: March 31, June 30, and August 31. CMS will use data for the same time periods for the Medicare and other payer portions of Threshold Score calculations under the All-Payer Combination Option. CMS will use the payment amount or patient count method, applying the more advantageous of the two for both the Medicare and other payer portions of the Threshold score calculation, regardless of the method used for the Medicare Threshold Score calculation. (2) An APM Entity may request that CMS make QP determinations at the APM Entity level, an eligible clinician may request that CMS make QP determinations at the eligible clinician level, and an eligible clinician or an APM Entity may request that CMS makes QP determinations at the TINlevel in instances where all clinicians who reassigned billing rights to the TIN are participating in a single APM Entity. CMS makes QP determinations at either the APM Entity, eligible clinician, or TIN level. Eligible clinicians assessed at the eligible clinician level under the Medicare Option at § 414.1425(b)(2) will be assessed at the eligible clinician level only under the All-Payer Combination Option. Eligible Clinicians may meet the Medicare and the All-Payer Combination Option thresholds using the payment amount method for both thresholds, the patient account method for both thresholds, or the payment amount method for one threshold and the patient account method for the other threshold. (3) CMS uses data at the same level for the Medicare and other payer portions of Threshold Score calculations under the All-Payer Combination Option. When QP determinations are made at the eligible clinician or, at the TIN level when all clinicians who have reassigned billing rights to the TIN are included in a single APM Entity; and if the Medicare Threshold score for the APM Entity group is higher than when calculated for the eligible clinician or TIN, CMS makes QP determinations using a weighted Medicare Threshold Score that is factored into an All-Payer Combination Option Threshold Score. * * * * * ■ 45. Section 414.1445 is amended by revising paragraph (b)(1), adding paragraph (c)(2)(i), and reserving paragraph (c)(2)(ii) to read as follows: § 414.1445 Determination of other payer advanced APMs. * * * * * (b) * * * (1) Payer initiated Other Payer Advanced APM determination process. Beginning in 2018, and each year PO 00000 Frm 00257 Fmt 4701 Sfmt 4700 60091 thereafter, at a time determined by CMS a payer with a Medicare Health Plan payment arrangement may request, in a form and manner specified by CMS, that CMS determine whether a Medicare Health Plan payment arrangement meets the Other Payer Advanced APM criteria set forth in § 414.1420. A payer with a Medicare Health Plan payment arrangement must submit its requests by the annual Medicare Advantage bid deadline of the year prior to the relevant QP Performance Period. A Medicare Health Plan is a Medicare Advantage plan, a section 1876 cost plan, a PACE organization operated under section 1894, and any similar plan which provides Medicare benefits under demonstration or waiver authority (other than an APM as defined in section 1833(z)(3)(C) of the Act). * * * * * (c) * * * (2) * * * (i) Based on the submission by an eligible clinician or payer of evidence that CMS determines sufficiently demonstrates that CEHRT is used as specified in § 414.1420(b) by participants in the payment arrangement, CMS will consider the CEHRT criterion in § 414.1420(b) is satisfied for that payment arrangement. (ii) [Reserved] * * * * * PART 415—SERVICES FURNISHED BY PHYSICIANS IN PROVIDERS, SUPERVISING PHYSICIANS IN TEACHING SETTINGS, AND RESIDENTS IN CERTAIN SETTINGS 46. The authority citation for part 415 is revised to read as follows: ■ Authority: 42 U.S.C. 1302 and 1395hh. 47. Section 415.172 is amended by revising paragraph (b) to read as follows: ■ § 415.172 Physician fee schedule payment for services of teaching physicians. * * * * * (b) Documentation. Except for services furnished as set forth in §§ 415.174 (concerning an exception for services furnished in hospital outpatient and certain other ambulatory settings), 415.176 (concerning renal dialysis services), and 415.184 (concerning psychiatric services), the medical records must document the teaching physician was present at the time the service is furnished. The presence of the teaching physician during procedures and evaluation and management services may be demonstrated by the notes in the medical records made by a physician, resident, or nurse. * * * * * E:\FR\FM\23NOR3.SGM 23NOR3 60092 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 48. Section 415.174 is amended— a. In paragraph (a)(3)(iii) by removing ‘‘;’’ and adding in its place ‘‘; and’’; ■ b. In paragraph (a)(3)(iv) by removing ‘‘; and’’ and adding in its place ‘‘.’’; ■ c. By removing paragraph (a)(3)(v); and ■ d. By adding paragraph (a)(6). The addition reads as follows: (a) * * * (6) The medical records must document the extent of the teaching physician’s participation in the review and direction of services furnished to each beneficiary. The extent of the teaching physician’s participation may be demonstrated by the notes in the medical records made by a physician, resident, or nurse. * * * * * a. In paragraph (b) by removing the phrase ‘‘under § 425.604, § 425.606 or § 425.610’’ and adding in its place the phrase ‘‘under § 425.604, § 425.606, § 425.609 or § 425.610’’; and ■ b. In paragraph (c) by removing the phrase ‘‘under § 425.606 or § 425.610’’ and adding in its place the phrase ‘‘under § 425.606, § 425.609 or § 425.610’’. ■ 52. Section 425.200 is amended— ■ a. By revising paragraph (a); ■ b. By revising the heading of paragraph (b); ■ c. By removing paragraph (b)(2) introductory text, adding a heading for paragraph (b)(2), and revising paragraph (b)(2)(ii); and ■ d. By removing paragraph (b)(3) introductory text, adding a heading for paragraph (b)(3); and ■ e. By revising paragraphs (c) and (d). The revisions and additions read as follows: PART 425—MEDICARE SHARED SAVINGS PROGRAM § 425.200 CMS. ■ ■ § 415.174 Exception: Evaluation and management services furnished in certain centers. 49. The authority citation for part 425 is revised to read as follows: ■ Authority: 42 U.S.C. 1302, 1306, 1395hh, and 1395jjj. 50. Section 425.20 is amended— a. By revising the definition of ‘‘Agreement period’’; ■ b. By adding in alphabetical order definitions for ‘‘Certified Electronic Health Record Technology (CEHRT)’’ and ‘‘Eligible clinician’’; and ■ c. By revising the definition of ‘‘Performance year’’. The revisions and additions read as follows: ■ ■ § 425.20 Definitions. amozie on DSK3GDR082PROD with RULES3 * * * * * Agreement period means the term of the participation agreement. * * * * * Certified Electronic Health Record Technology (CEHRT) has the same meaning given this term under § 414.1305 of this chapter. * * * * * Eligible clinician has the same meaning given this term under § 414.1305 of this chapter. * * * * * Performance year means the 12month period beginning on January 1 of each year during the agreement period, unless otherwise specified in § 425.200(c) or noted in the participation agreement. * * * * * § 425.100 ■ [Amended] 51. Section 425.100 is amended— VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 ■ Participation agreement with (a) General. In order to participate in the Shared Savings Program, an ACO must enter into a participation agreement with CMS for a period of not less than the number of years specified in this section. (b) Agreement period.* * * (2) For 2013 and through 2016.* * * (ii) The term of the participation agreement is 3 years unless all of the following conditions are met to extend the participation agreement by 6 months: (A) The ACO entered an agreement period starting on January 1, 2016. (B) The ACO elects to extend its agreement period until June 30, 2019. (1) The ACO’s election to extend its agreement period is made in the form and manner and according to the timeframe established by CMS; and (2) An ACO executive who has the authority to legally bind the ACO must certify the election described in paragraph (b)(2)(ii)(B) of this section. (3) For 2017 and all subsequent years. * * * (c) Performance year. The ACO’s performance year under the participation agreement is the 12 month period beginning on January 1 of each year during the term of the participation agreement unless otherwise noted in its participation agreement, and except as follows: (1) For an ACO with a start date of April 1, 2012, or July 1, 2012, the ACO’s first performance year is defined as 21 months or 18 months, respectively. (2) For an ACO that entered a first or second agreement period with a start date of January 1, 2016, and that elects PO 00000 Frm 00258 Fmt 4701 Sfmt 4700 to extend its agreement period by a 6month period under paragraph (b)(2)(ii)(B) of this section, the ACO’s fourth performance year is the 6-month period between January 1, 2019, and June 30, 2019. (d) Submission of measures. For each performance year of the agreement period, ACOs must submit measures in the form and manner required by CMS according to § 425.500(c), and as applicable according to §§ 425.608 and 425.609. * * * * * § 425.221 [Amended] 53. Section 425.221 is amended— a. In paragraph (b)(1)(i) by removing the phrase ‘‘December 31st of such performance year’’ and adding in its place the phrase ‘‘the last calendar day of the performance year’’; and ■ b. In paragraph (b)(2) by removing the phrase ‘‘December 31 of a performance year’’ and adding in its place the phrase ‘‘the last calendar day of a performance year’’. ■ 54. Section 425.302 is amended— ■ a. In paragraph (a)(3)(i) by removing the phrase ‘‘requirements; and’’ and adding in its place the phrase ‘‘requirements;’’; ■ b. In paragraph (a)(3)(ii) by removing the phrase ‘‘owed to CMS.’’ and adding in its place the phrase ‘‘owed to CMS; and’’; and ■ c. Adding paragraph (a)(3)(iii). The addition reads as follows: ■ ■ § 425.302 Program requirements for data submission and certifications. (a) * * * (3) * * * (iii) That the percentage of eligible clinicians participating in the ACO that use CEHRT to document and communicate clinical care to their patients or other health care providers meets or exceeds the applicable percentage specified by CMS at § 425.506(f). * * * * * § 425.315 [Amended] 55. Section 425.315 is amended in paragraph (a)(1)(ii) by removing the phrase ‘‘§ 425.604(f), § 425.606(h) or § 425.610(h)’’ and adding in its place the phrase ‘‘§ 425.604(f), § 425.606(h), § 425.609(e) or § 425.610(h)’’. ■ 56. Section 425.400 is amended by— ■ a. Revising paragraph (a)(1)(ii); ■ b. Revising paragraphs (c)(1)(iv) introductory text, (c)(1)(iv)(A), (c)(1)(iv)(B) introductory text, and (c)(1)(iv)(B)(5); and ■ c. Adding paragraphs (c)(1)(iv)(B)(6) and (7). ■ E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations The revisions and additions read as follows: amozie on DSK3GDR082PROD with RULES3 § 425.400 57. Section 425.401 is amended by revising paragraph (b) introductory text to read as follows: ■ General. (a)(1) * * * (ii) CMS applies a step-wise process based on the beneficiary’s utilization of primary care services provided under Title XVIII by a physician who is an ACO professional during each performance year for which shared savings are to be determined and, with respect to ACOs participating in a 6month performance year during CY 2019, during the entirety of CY 2019 as specified in § 425.609. * * * * * (c) * * * (1) * * * (iv) For performance years starting on January 1, 2019, and subsequent performance years as follows: (A) CPT codes: (1) 99201 through 99215 (codes for office or other outpatient visit for the evaluation and management of a patient). (2) 99304 through 99318 (codes for professional services furnished in a nursing facility; services identified by these codes furnished in a SNF are excluded). (3) 99319 through 99340 (codes for patient domiciliary, rest home, or custodial care visit). (4) 99341 through 99350 (codes for evaluation and management services furnished in a patients’ home for claims identified by place of service modifier 12). (5) 99487, 99489 and 99490 (codes for chronic care management). (6) 99495 and 99496 (codes for transitional care management services). (7) 99497 and 99498 (codes for advance care planning). (8) 96160 and 96161 (codes for administration of health risk assessment). (9) 99354 and 99355 (add-on codes, for prolonged evaluation and management or psychotherapy services beyond the typical service time of the primary procedure; when the base code is also a primary care service code under this paragraph (c)(1)). (10) 99484, 99492, 99493 and 99494 (codes for behavioral health integration services). (B) HCPCS codes: * * * * * (5) G0444 (codes for annual depression screening service). (6) G0442 (code for alcohol misuse screening service). (7) G0443 (code for alcohol misuse counseling service). VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 § 425.401 Criteria for a beneficiary to be assigned to an ACO. * * * * * (b) A beneficiary is excluded from the prospective assignment list of an ACO that is participating under prospective assignment under § 425.400(a)(3) at the end of a performance or benchmark year and quarterly during each performance year consistent with § 425.400(a)(3)(ii), or at the end of CY 2019 as specified in § 425.609(b)(1)(ii), if the beneficiary meets any of the following criteria during the performance or benchmark year: * * * * * ■ 58. Section 425.402 is amended by revising paragraph (e)(2) to read as follows: § 425.402 Basic assignment methodology. * * * * * (e) * * * (2) Beneficiaries are added to the ACO’s list of assigned beneficiaries if all of the following conditions are satisfied: (i) For performance year 2018: (A) The beneficiary must have had at least one primary care service during the assignment window as defined under § 425.20 with a physician who is an ACO professional in the ACO who is a primary care physician as defined under § 425.20 or who has one of the primary specialty designations included in paragraph (c) of this section. (B) The beneficiary meets the eligibility criteria established at § 425.401(a) and must not be excluded by the criteria at § 425.401(b). The exclusion criteria at § 425.401(b) apply for purposes of determining beneficiary eligibility for alignment to ACOs under all tracks based on the beneficiary’s designation of an ACO professional as responsible for coordinating their overall care under paragraph (e) of this section. (C) The beneficiary must have designated an ACO professional who is a primary care physician as defined at § 425.20, a physician with a specialty designation included at paragraph (c) of this section, or a nurse practitioner, physician assistant, or clinical nurse specialist as responsible for coordinating their overall care. (D) If a beneficiary has designated a provider or supplier outside the ACO who is a primary care physician as defined at § 425.20, a physician with a specialty designation included at paragraph (c) of this section, or a nurse practitioner, physician assistant, or clinical nurse specialist, as responsible PO 00000 Frm 00259 Fmt 4701 Sfmt 4700 60093 for coordinating their overall care, the beneficiary is not added to the ACO’s list of assigned beneficiaries under the assignment methodology in paragraph (b) of this section. (ii) For performance years starting on January 1, 2019, and subsequent performance years: (A) The beneficiary meets the eligibility criteria established at § 425.401(a) and must not be excluded by the criteria at § 425.401(b). The exclusion criteria at § 425.401(b) apply for purposes of determining beneficiary eligibility for alignment to an ACO based on the beneficiary’s designation of an ACO professional as responsible for coordinating their overall care under paragraph (e) of this section, regardless of the ACO’s assignment methodology selection under § 425.400(a)(4)(ii). (B) The beneficiary must have designated an ACO professional as responsible for coordinating their overall care. (C) If a beneficiary has designated a provider or supplier outside the ACO as responsible for coordinating their overall care, the beneficiary is not added under the assignment methodology in paragraph (b) of this section to the ACO’s list of assigned beneficiaries for a 12-month performance year or the ACO’s list of assigned beneficiaries for a 6-month performance year, which is based on the entire CY 2019 as provided in § 425.609. (D) The beneficiary is not assigned to an entity participating in a model tested or expanded under section 1115A of the Act under which claims-based assignment is based solely on claims for services other than primary care services and for which there has been a determination by the Secretary that waiver of the requirement in section 1899(c)(2)(B) of the Act is necessary solely for purposes of testing the model. * * * * * § 425.404 [Amended] 59. Section 425.404 is amended in paragraph (b) by removing the phrase ‘‘For performance year 2019 and subsequent performance years’’ and adding in its place the phrase ‘‘For performance years starting on January 1, 2019, and subsequent performance years’’. ■ 60. Section 425.502 is amended— ■ a. In paragraph (e)(4)(vi) by removing the phrase ‘‘For performance year 2017’’ and adding in its place the phrase ‘‘For performance year 2017 and subsequent performance years’’; ■ b. By adding a new paragraph (e)(4)(vii); ■ c. By revising paragraph (f) introductory text; ■ E:\FR\FM\23NOR3.SGM 23NOR3 60094 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations d. By redesignating paragraphs (f)(1) and (2) as paragraphs (f)(2)(i) and (ii); ■ e. By adding a new paragraph (f)(1); ■ f. By adding a new paragraph (f)(2) introductory text; ■ g. In newly redesignated paragraph (f)(2)(i) by removing the phrase ‘‘for performance year 2017’’ and adding in its place the phrase ‘‘for the relevant performance year’’; ■ h. By removing paragraph (f)(4); and ■ i. By redesignating paragraph (f)(5) as paragraph (f)(4). The revisions and additions read as follows: ■ § 425.502 Calculating the ACO quality performance score. amozie on DSK3GDR082PROD with RULES3 * * * * * (e) * * * (4) * * * (vii) For performance year 2017 and subsequent performance years, if an ACO receives the mean Shared Savings Program ACO quality score under paragraph (f) of this section, in the next performance year for which the ACO receives a quality performance score based on its own quality reporting, quality improvement is measured based on a comparison between the performance in that year and the most recently available prior performance year in which the ACO reported quality. (f) Extreme and uncontrollable circumstances. For performance year 2017 and subsequent performance years, including the applicable quality data reporting period for the performance year if the quality reporting period is not extended, CMS uses an alternative approach to calculating the quality score for ACOs affected by extreme and uncontrollable circumstances instead of the methodology specified in paragraphs (a) through (e) of this section as follows: (1) CMS determines the ACO was affected by an extreme and uncontrollable circumstance based on either of the following: (i) Twenty percent or more of the ACO’s assigned beneficiaries reside in an area identified under the Quality Payment Program as being affected by an extreme and uncontrollable circumstance. (A) Assignment is determined under subpart E of this part. (B) In making this determination for performance year 2017, CMS uses the final list of beneficiaries assigned to the ACO for the performance year. For performance year 2018 and subsequent performance years, CMS uses the list of assigned beneficiaries used to generate the Web Interface quality reporting sample. (ii) The ACO’s legal entity is located in an area identified under the Quality VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 Payment Program as being affected by an extreme and uncontrollable circumstance. An ACO’s legal entity location is based on the address on file for the ACO in CMS’ ACO application and management system. (2) If CMS determines the ACO meets the requirements of paragraph (f)(1) of this section, CMS calculates the ACO’s quality score as follows: * * * * * ■ 61. Section 425.506 is amended— ■ a. In paragraph (b) by removing the phrase ‘‘As part of the quality performance score’’ and adding in its place the phrase ‘‘For performance years 2012 through 2018, as part of the quality performance score’’; ■ b. In paragraph (c) by removing the phrase ‘‘Performance on this measure’’ and adding in its place the phrase ‘‘For performance years 2012 through 2018, performance on this measure’’; ■ c. In paragraph (e) introductory text by removing the phrase ‘‘For 2017 and subsequent years’’ and adding in its place the phrase ‘‘For 2017 and 2018’’; and ■ d. By adding paragraph (f). The addition reads as follows: § 425.506 Incorporating reporting requirements related to adoption of certified electronic health record technology. * * * * * (f) For performance years starting on January 1, 2019, and subsequent performance years, ACOs in a track that— (1) Does not meet the financial risk standard to be an Advanced APM must certify annually that the percentage of eligible clinicians participating in the ACO that use CEHRT to document and communicate clinical care to their patients or other health care providers meets or exceeds 50 percent; or (2) Meets the financial risk standard to be an Advanced APM must certify annually that the percentage of eligible clinicians participating in the ACO that use CEHRT to document and communicate clinical care to their patients or other health care providers meets or exceeds the threshold established under § 414.1415(a)(1)(i) of this chapter. ■ 62. Section 425.602 is amended by adding paragraph (c) to read as follows: § 425.602 Establishing, adjusting, and updating the benchmark for an ACO’s first agreement period. * * * * * (c) January 1, 2019 through June 30, 2019 performance year. In determining performance for the January 1, 2019 through June 30, 2019 performance year PO 00000 Frm 00260 Fmt 4701 Sfmt 4700 described in § 425.609(b) CMS does all of the following: (1) When adjusting the benchmark using the methodology set forth in paragraph (a)(9) of this section and § 425.609(b), CMS adjusts for severity and case mix between BY3 and CY 2019. (2) When updating the benchmark using the methodology set forth in paragraph (b) of this section and § 425.609(b), CMS updates the benchmark based on growth between BY3 and CY 2019. ■ 63. Section 425.603 is amended by adding paragraph (g) to read as follows: § 425.603 Resetting, adjusting, and updating the benchmark for a subsequent agreement period. * * * * * (g) In determining performance for the January 1, 2019 through June 30, 2019 performance year described in § 425.609(b) CMS does all of the following: (1) When adjusting the benchmark using the methodology set forth in paragraph (c)(10) of this section and § 425.609(b), CMS adjusts for severity and case mix between BY3 and CY 2019. (2) When updating the benchmark using the methodology set forth in paragraph (d) of this section and § 425.609(b), CMS updates the benchmark based on growth between BY3 and CY 2019. ■ 64. Section 425.604 is amended by adding paragraph (g) to read as follows: § 425.604 Calculation of savings under the one-sided model. * * * * * (g) January 1, 2019 through June 30, 2019 performance year. Shared savings for the January 1, 2019 through June 30, 2019 performance year are calculated as described in § 425.609. ■ 65. Section 425.606 is amended— ■ a. In paragraph (i) introductory text by removing the phrase ‘‘For performance year 2017’’ and adding in its place the phrase ‘‘For performance year 2017 and subsequent performance years’’; ■ b. In paragraph (i)(1) remove the phrase ‘‘2017’’; and ■ c. By adding paragraph (j). The addition reads as follows: § 425.606 Calculation of shared savings and losses under Track 2. * * * * * (j) January 1, 2019 through June 30, 2019. Shared savings or shared losses for the January 1, 2019 through June 30, 2019 performance year are calculated as described in § 425.609. ■ 66. Section 425.609 is added to read as follows: E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations amozie on DSK3GDR082PROD with RULES3 § 425.609 Determining performance for a 6-month performance year during CY 2019. (a) General. An ACO’s financial and quality performance for a 6-month performance year during 2019 are determined as described in this section. (b) January 2019 through June 2019. For ACOs participating in a 6-month performance year from January 1, 2019, through June 30, 2019, under § 425.200(b)(2)(ii)(B), CMS reconciles the ACO for the period from January 1, 2019, through June 30, 2019, after the conclusion of CY 2019, based on the 12month calendar year and pro-rates shared savings or shared losses to reflect the ACO’s participation from January 1, 2019, through June 30, 2019. CMS does all of the following to determine financial and quality performance: (1) Uses the ACO participant list in effect for the performance year beginning January 1, 2019, to determine beneficiary assignment, using claims for the entire calendar year, as specified in §§ 425.402 and 425.404, and according to the ACO’s track as specified in § 425.400. (i) For ACOs under preliminary prospective assignment with retrospective reconciliation the assignment window is CY 2019. (ii) For ACOs under prospective assignment— (A) Medicare fee-for-service beneficiaries are prospectively assigned to the ACO based on the beneficiary’s use of primary care services in the most recent 12 months for which data are available; and (B) Beneficiaries remain prospectively assigned to the ACO at the end of CY 2019 if they do not meet any of the exclusion criteria under § 425.401(b) during the calendar year. (2) Uses the ACO’s quality performance for the 2019 reporting period to determine the ACO’s quality performance score as specified in § 425.502. The ACO’s latest certified ACO participant list is used to determine the quality reporting samples for the 2019 reporting year for an ACO that extends its participation agreement for the 6-month performance year from January 1, 2019, through June 30, 2019, under § 425.200(b)(2)(ii)(B). (3) Uses the methodology for calculating shared savings or shared losses applicable to the ACO under the terms of the participation agreement that was in effect on January 1, 2019. (i) The ACO’s historical benchmark is determined according to either § 425.602 (first agreement period) or § 425.603 (second agreement period) except as follows: (A) The benchmark is adjusted for changes in severity and case mix VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 between BY3 and CY 2019 using the methodology that accounts separately for newly and continuously assigned beneficiaries using prospective HCC risk scores and demographic factors as described under §§ 425.604(a)(1) through (3), 425.606(a)(1) through (3), and 425.610(a)(1) through (3). (B) The benchmark is updated to CY 2019 according to the methodology described under § 425.602(b), § 425.603(b), or § 425.603(d), based on whether the ACO is in its first or second agreement period, and for an ACO in a second agreement period, the date on which that agreement period began. (ii) The ACO’s financial performance is determined based on the track the ACO is participating under during the performance year starting on January 1, 2019 (§ 425.604, § 425.606 or § 425.610), unless otherwise specified. In determining ACO financial performance, CMS does all of the following: (A) Average per capita Medicare Parts A and B fee-for-service expenditures for CY 2019 are calculated for the ACO’s performance year assigned beneficiary population identified in paragraph (b)(1) of this section. (B) Expenditures calculated in paragraph (b)(3)(ii)(A) of this section are compared to the ACO’s updated benchmark determined according to paragraph (b)(3)(i) of this section. (C)(1) The ACO’s performance year assigned beneficiary population identified in paragraph (b)(1) of this section is used to determine the MSR for Track 1 ACOs and the variable MSR/ MLR for ACOs in a two-sided model that selected this option at the start of their agreement period. For two-sided model ACOs that selected a fixed MSR/ MLR at the start of the ACO’s agreement period, this fixed MSR/MLR is applied. In the event an ACO’s performance year assigned population identified in paragraph (b)(1) of this section is below 5,000 beneficiaries, the MSR/MLR is determined according to § 425.110(b). (2) To qualify for shared savings an ACO must do all of the following: (i) Have average per capita Medicare Parts A and B fee-for-service expenditures for its assigned beneficiary population for CY 2019 below its updated benchmark costs for the year by at least the MSR established for the ACO based on the track the ACO is participating under during the performance year starting on January 1, 2019 (§ 425.604, § 425.606 or § 425.610) and paragraph (b)(3)(ii)(C)(1) of this section. (ii) Meet the minimum quality performance standards established PO 00000 Frm 00261 Fmt 4701 Sfmt 4700 60095 under § 425.502 and according to paragraph (b)(2) of this section. (iii) Otherwise maintain its eligibility to participate in the Shared Savings Program under this part. (3) To be responsible for sharing losses with the Medicare program, an ACO’s average per capita Medicare Parts A and B fee-for-service expenditures for its assigned beneficiary population for CY 2019 must be above its updated benchmark costs for the year by at least the MLR established for the ACO based on the track the ACO is participating under during the performance year starting on January 1, 2019 (§ 425.606 or § 425.610) and paragraph (b)(3)(ii)(C)(1) of this section. (D) For an ACO that meets all the requirements to receive a shared savings payment under paragraph (b)(3)(ii)(C)(2) of this section— (1) The final sharing rate, determined based on the track the ACO is participating under during the performance year starting on January 1, 2019 (§ 425.604, § 425.606 or § 425.610), is applied to all savings under the updated benchmark specified under paragraph (b)(3)(i) of this section, not to exceed the performance payment limit for the ACO based on its track; and (2) After applying the applicable performance payment limit, CMS prorates any shared savings amount determined under paragraph (b)(3)(ii)(D)(1) of this section by multiplying the amount by one-half, which represents the fraction of the calendar year covered by the period from January 1, 2019, through June 30, 2019. (E) For an ACO responsible for shared losses under paragraph (b)(3)(ii)(C)(3) of this section— (1) The shared loss rate, determined based on the track the ACO is participating under during the performance year starting on January 1, 2019 (§ 425.606 or § 425.610), is applied to all losses under the updated benchmark specified under paragraph (b)(3)(i) of this section, not to exceed the loss recoupment limit for the ACO based on its track; and (2) After applying the applicable loss recoupment limit, CMS pro-rates any shared losses amount determined under paragraph (b)(3)(ii)(E)(1) of this section by multiplying the amount by one-half, which represents the fraction of the calendar year covered by the period from January 1, 2019, through June 30, 2019. (c) [Reserved] (d) Extreme and uncontrollable circumstances. For ACOs affected by extreme and uncontrollable circumstances during CY 2019— E:\FR\FM\23NOR3.SGM 23NOR3 60096 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations (1) In calculating the amount of shared losses owed, CMS makes adjustments to the amount determined in paragraph (b)(3)(ii)(E)(1) of this section, as specified in § 425.606(i) or § 425.610(i), as applicable; and (2) In determining the ACO’s quality performance score for the 2019 quality reporting period, CMS uses the alternative scoring methodology specified in § 425.502(f). (e) Notification of savings and losses. CMS notifies the ACO of shared savings or shared losses for the January 1, 2019 through June 30, 2019 performance year, consistent with the notification requirements specified in §§ 425.604(f), 425.606(h), and 425.610(h), as applicable: (1) CMS notifies an ACO in writing regarding whether the ACO qualifies for a shared savings payment, and if so, the amount of the payment due. (2) CMS provides written notification to an ACO of the amount of shared losses, if any, that it must repay to the program. (3) If an ACO has shared losses, the ACO must make payment in full to CMS within 90 days of receipt of notification. ■ 67. Section 425.610 is amended— ■ a. In paragraph (i) introductory text by removing the phrase ‘‘For performance year 2017’’ and adding in its place the phrase ‘‘For performance year 2017 and subsequent performance years’’; ■ b. In paragraph (i)(1) by removing the phrase ‘‘2017’’; and ■ c. By adding paragraph (j). The addition reads as follows: § 425.610 Calculation of shared savings and losses under Track 3. * * * * * (j) January 1, 2019 through June 30, 2019 performance year. Shared savings or shared losses for the January 1, 2019 through June 30, 2019 performance year are calculated as described in § 425.609. ■ 68. Section 425.702 is amended by adding paragraph (d) to read as follows: § 425.702 Aggregate reports. * * * * (d) For an ACO eligible to be reconciled under § 425.609(b), CMS shares with the ACO quarterly aggregate reports as provided in paragraphs (b) and (c)(1)(ii) of this section for CY 2019. amozie on DSK3GDR082PROD with RULES3 * PART 495—STANDARDS FOR THE ELECTRONIC HEALTH RECORD TECHNOLOGY INCENTIVE PROGRAM 69. The authority citation for part 495 is revised to read as follows: ■ Authority: 42 U.S.C. 1302 and 1395hh. 70. Section 495.4 is amended in the definition of ‘‘EHR reporting period’’ by ■ VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 adding paragraph (1)(v) to read as follows: § 495.4 Definitions. * * * * * EHR reporting period. * * * (1) * * * (v) Under the Medicaid Promoting Interoperability Program, for the CY 2021 payment year: (A) For the EP first demonstrating he or she is a meaningful EHR user, any continuous 90-day period within CY 2021 that ends before October 31, 2021, or that ends before an earlier date in CY 2021 that is specified by the state and approved by CMS in the State Medicaid HIT plan described at § 495.332. (B) For the EP who has successfully demonstrated he or she is a meaningful EHR user in any prior year, any continuous 90-day period within CY 2021 that ends before October 31, 2021, or that ends before an earlier date in CY 2021 that is specified by the state and approved by CMS in the State Medicaid HIT plan described at § 495.332. * * * * * ■ 71. Section 495.24 is amended by revising paragraphs (d)(6)(i)(B) and (d)(8)(i)(B)(2) to read as follows: § 495.24 Stage 3 meaningful use objectives and measures for EPs, eligible hospitals and CAHs for 2019 and subsequent years. * * * * * (d) * * * (6) * * * (i) * * * (B) Measures. In accordance with paragraph (a)(2) of this section, an EP must satisfy 2 out of the 3 following measures in paragraphs (d)(6)(i)(B)(1) through (3) of this section except those measures for which an EP qualifies for an exclusion under paragraph (a)(3) of this section. (1) During the EHR reporting period, more than 5 percent of all unique patients (or their authorized representatives) seen by the EP actively engage with the electronic health record made accessible by the provider and do either of the following: (i) View, download or transmit to a third party their health information; (ii) Access their health information through the use of an API that can be used by applications chosen by the patient and configured to the API in the provider’s CEHRT; or (iii) A combination of paragraphs (d)(6)(i)(B)(1)(i) and (ii) of this section. (2) A secure message was sent using the electronic messaging function of CEHRT to the patient (or their authorized representatives), or in response to a secure message sent by the PO 00000 Frm 00262 Fmt 4701 Sfmt 4700 patient, for more than 5 percent of all unique patients seen by the EP during the EHR reporting period. (3) Patient generated health data or data from a nonclinical setting is incorporated into the CEHRT for more than 5 percent of all unique patients seen by the EP during the EHR reporting period. * * * * * (8) * * * (i) * * * (B) * * * (2) Syndromic surveillance reporting. The EP is in active engagement with a public health agency to submit syndromic surveillance data from an urgent care setting, or from any other setting from which ambulatory syndromic surveillance data are collected by the state or a local public health agency. * * * * * 72. Section 495.332 is amended by adding paragraphs (f)(3), (4), and (5) to read as follows: ■ § 495.332 State Medicaid health information technology (HIT) plan requirements. * * * * * (f) * * * (3) An alternative date within CY 2021 by which all ‘‘EHR reporting periods’’ (as defined under § 495.4) for the CY 2021 payment year for Medicaid EPs demonstrating they are meaningful EHR users must end. The alternative date selected by the state must be earlier than October 31, 2021, and must not be any earlier than the day prior to the attestation deadline for Medicaid EPs attesting to that state. (4) An alternative date within CY 2021 by which all clinical quality measure reporting periods for the CY 2021 payment year for Medicaid EPs demonstrating they are meaningful EHR users must end. The alternative date selected by the state must be earlier than October 31, 2021, and must not be any earlier than the day prior to the attestation deadline for Medicaid EPs attesting to that state. (5) For the CY 2019 payment year and beyond, a state-specific listing of which clinical quality measures selected by CMS are considered to be high priority measures for purposes of Medicaid EP clinical quality measure reporting. * * * * * E:\FR\FM\23NOR3.SGM 23NOR3 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations Dated: October 26, 2018. Seema Verma, Administrator, Centers for Medicare & Medicaid Services. Dated: October 30, 2018. Alex M. Azar II, Secretary, Department of Health and Human Services. 60097 specialty measure sets will continue to apply for the 2021 MIPS payment year and future years. BILLING CODE 4120–01–P Appendix 1: Finalized MIPS Quality Measures VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00263 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.080</GPH> amozie on DSK3GDR082PROD with RULES3 Note: Except as otherwise finalized in this final rule, previously finalized measures and 60098 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations .. . Functiona IStatus F 0 IIOWIDI!; L urn b ar S. spme F USIOD A2Avera~~;e Ch an~~;em Cateeory NQF#: Quality#: Description: Measure Steward: s ur~~;ery Description 2643 469 For patients age 18 and older undergoing lumbar spine fusion surgery, the average change from pre-operative functional status to 1 year (9 to 15 months) post-operative functional status using the Oswestry Disability Index (ODI version 2.la) patient reported outcome tool. Minnesota Community Measurement The average change (preoperative to 1 year post-operative) in functional status for all patients in the denominator. There is not a traditional numerator for this measure; the measure calculating the average change in functional status score from preoperative to post-operative functional status score. The measure is NOT aiming for a numerator target value for a post-operative ODI score. The average change is calculated as follows: Change is first calculated for each patient and then changed scores are summed and then an average is determined. Measure calculation takes into account those patients that have an improvement and those patients whose function decreases post-operatively. For example: Patient Pre-op ODI :I Post-op ODI :I Change in ODI Patient A: I 47 :I 18 :I 29 Patient B: I 45 :I 52 :I -7 Patient C: I 56 :I 12 :I 44 Patient D: I 62 :I 25 :I 37 Patient E: I 42 :I 57 :I -15 Patient F: I 51 :I 10 :I 41 Patient G: I 62 :I 25 :I 37 Patient H: I 43 :I 20 :I 23 Patient I: I 74 :I 35 :I 39 Patient J: I 59 :I 23 :I 36 Average change in ODI 1 year post-op 26.4 points on a 100 point scale Eligible Population: Patients with lumbar spine fusion procedures (Arthrodesis Value Set) occurring during a 12-month period for patients age 18 and older at the start of that period. Numerator: Denominator: Patients within the eligible population whose functional status was measured by the Oswestry Disability Index, version 2.la (ODI, v2.la) within 3 months preoperatively AND at 1 year (+/- 3 months) postoperatively. Denominator: Exclusions: Measure Type: Measure Domain: High Priority Measure: Collection Type: Rationale: *The measure of average change in function can only be calculated if both a pre-operative and post-operative PRO assessment are completed The following exclusions must be applied to the eligible population: Patient had cancer (Spine Cancer Value Set), fracture (Spine Fracture Value Set) or infection (Spine Infection Value Set) related to the spine. Patient had idiopathic or congenital scoliosis (Congenital Scoliosis Value Set) Patient Reported Outcome Person and Caregiver-Centered Experience and Outcomes Yes (Patient Reported Outcome) MIPS CQMs Specifications We are adopting this measure because it measures an important patient reported outcome evaluating the functional status change from preto post-operative. Results of the measure can be used by clinicians in evaluating whether the patient's functional status has improved postoperatively. The MAP supported this measure for rulemaking and recognized that improvement in functional status is an important outcome to patients and was encouraged by the potential addition of more patient-reported outcome measures to the MIPS set. Note: Refer to the MAP Spreadsheet of Final Recommendations to CMS and HHS at https://www.qualitvforum.org/WorkArea/linkit.asox?Linkidentifier=id&ItemiD=86972. Comment: One commenter supported this new measure and applauded CMS for proposing to adopt four patient-reported outcome measures. The commenter stated that patient-reported outcomes reflect issues that are important to patients and provide a valuable perspective on care that cannot be obtained from other data sources (for example, severity of pain, physical functioning). Another commenter is pleased this measure emphasizes the change in functional status. Response: We thank the commenters for their support. Comment: One commenter recommended using the Patient-Reported Outcome Measurement Information System (PROMIS) as an alternative to the Oswestry Disability Index (ODI) as the functional status assessment basis for this quality measure. Response: The measure steward has developed and tested this measure using the ODI tool to assess the change in functional status. We do not believe that the PROMIS scale will add value to this quality measure. Rather, we believe that the addition of the PROMIS scale introduces variability and would not provide a standardized tool to assess functional status. We do not own this measure and encourage the commenter to collaborate with the measure steward to expand the assessment tools. Response: Although we agree PROMs can be challenging to implement, the measure steward has fully tested this measure for validity and reliability to obtain NQF VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00264 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.081</GPH> amozie on DSK3GDR082PROD with RULES3 Comment: One commenter did not support the addition of this measure, stating that the validity, reliability, and informativeness of PROMs are uncertain. Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60099 Category I Description endorsement. PROMs have been deemed one of our priorities as it is important to ensure patients are engaged in their care and are an important component in evaluating outcomes. The Oswestry Disability Index is a standardized tool that will allow eligible clinicians to track the progress of their patient's functional improvement. Therefore, we respectfully disagree that PROMs are not informative for improving patient outcomes and clinician quality performance. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00265 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.082</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are finalizing the Average Change in Functional Status Following Lumbar Spine Fusion Surgery measure as proposed for the 2019 Performance Period and future years. 60100 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations .. . F uncttona IStatus F 0 IIOWIDR T ota IKn ee R epJacement sur2ery A3Avera2e Ch an2em Category NQF#: Quality#: Description: Measure Steward: Description 2653 470 For patients age 18 and older undergoing total knee replacement surgery, the average change from pre-operative functional status to 1 year (9 to 15 months) post-operative functional status using the Oxford Knee Score (OKS) patient reported outcome tool. Minnesota Community Measurement There is not a traditional numerator for this measure; the measure is calculating the average change in functional status score from pre-operative to post-operative functional status score. The measure is NOT aiming for a numerator target value for a postoperative OKS score. For example: The average change in knee function was an increase of 15.9 points 1 year post-operatively on a 48 point scale. The average change is calculated as follows: Change is first calculated for each patient and then changed scores are summed and then an average is determined. Measure calculation takes into account patients who have an improvement and patients whose function decreases post-operatively. For example: Patient Pre-op OKS :I Postop OKS:I Change in OKS Patient A: I 33 :I 45 :I 12 Patient K: I 24 :I 43 :I 19 Patient B: I 17 :I 39 :I 22 Patient L: I 29 :I 34 :I 5 Patient M: I 23 :I 39 :I 16 Patient C: I 16 :I 31 :I 15 Patient D: I 23 :I 40 :I 17 Patient N: I 29 :I 45 :I 16 Patient E: I 34 :I 42 :I 8 Patient 0: I 29 :I 45 :I 16 Patient F: I 10 :I 42 :I 32 Patient P: I 34 :I 41 :I 7 Patient Q: I 11 :I 14 :I 3 Patient G: I 14 :I 44 :I 30 Patient H: I 32 :I 44 :I 12 Patient R: I 13 :I 39 :I 26 Patient I: I 19 :I 45 :I 26 PatientS: 118 :I 45 :I 27 Patient J: I 26 :I 19 :I -7 Average change in OKS 1 year post-op 15.9 points on a 48 point scale Eligible Population: Patients with total knee replacement procedures (Primary TKR Value Set, Revision TKR Value Set) occurring during a 12-month period for patients age 18 and older at the start ofthat period. Numerator: Denominator: Exclusions: Measure Type: Measure Domain: High Priority Measure: Collection Type: Denominator: Patients within the eligible population whose functional status was measured by the Oxford Knee Score within 3 months preoperatively AND at 1 year (+/- 3 months) postoperatively *The measure of average change in function can only be calculated if both a pre-operative and post-operative PRO assessment are completed None Patient Reported Outcome Person and Caregiver-Centered Experience and Outcomes Yes (Patient Reported Outcome) MIPS CQMs Specifications We are adopting this measure because it measures an important patient reported outcome evaluating the functional status change from pre- to post-operative. Results can be used by clinicians in evaluating whether the patient's functional status has improved post-operatively. The MAP supported this measure for rulemaking and recognized that improvement in functional status is an important outcome to patients and was encouraged by the potential addition of more patient-reported outcome measures to the Rationale: MIPS set. Note: Refer to the MAP Spreadsheet of Final Recommendations to CMS and HHS at https://www.qualitvforum.org/WorkArea/linkit.asox?Linkidentifier=id&IterniD=86972. Comment: One commenter supported this new measure and applauded CMS for proposing to adopt four patient-reported outcome measures. They stated that patient-reported outcomes reflect issues that are important to patients and provide a valuable perspective on care that cannot be obtained from other data sources (for example, severity of pain, physical functioning). Several commenters are pleased this measure emphasizes the change in functional status and said that CMS should consider development of additional short and long-term outcomes measures for total joint procedures. Response: We thank the commenters for their support. Response: We thank the commenters for their input. The measure steward has developed and tested this measure using the OKS tool to assess the change in functional status. We do not believe that the introduction of additional tools (PROMIS, KOOS Jr, HOOS Jr.) will add value to this quality measure. Rather, we believe that the addition tools introduce variability and would not provide a standardized tool to assess functional status. We do not own this measure and encourage the commenter to collaborate with the measure steward to expand the assessment tools. In addition, it would not be appropriate to include the VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00266 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.083</GPH> amozie on DSK3GDR082PROD with RULES3 Comment: One commenter recommended using the Patient-Reported Outcome Measurement Information System (PROMIS) as an alternative to the Oxford Knee Score (OKS) as the functional status assessment basis for this quality measure. A second commenter expressed concern that the OKS is a proprietary tool and that there are a number of validated tools available. Another commenter recommended the use ofKOOS Jr and other potential measuring surveys to be available for use. The commenter also stated that KOOS Jr. and HOOS Jr. tools were selected as the preferred measurement instruments by the national orthopaedic specialty societies due to the ease of the tools. Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60101 Catee;ory I Description HOOS Jr. survey since the patient population within this measure includes patients that have had a total knee replacement procedure. The HOOS Jr. is used to assess hip injuries and osteoarthritis. Comment: One commenter did not support the addition of this measure, stating that the validity, reliability, and informativeness of PROMs are uncertain. Response: Although we agree PROMs can be challenging to implement, the measure steward has fully tested this measure for validity and reliability to obtain NQF endorsement. PROMs have been deemed one of our priorities as it is important to ensure patients are engaged in their care and are an important component in evaluating outcomes. Therefore, we respectfully disagree that PROMs are not informative for improving patient outcomes and clinician quality performance. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00267 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.084</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are finalizing the Average Change in Functional Status Following Total Knee Replacement Surgery measure as proposed for the 2019 Performance Period and future years. 60102 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations .. Category NQF#: Quality#: Description: Measure Steward: . F unctJona IStatus Fo IIowmg L urn b ar n·Iscectomy L ammotomy urgery A4Average Ch angem Description Not Applicable (NA) 471 For patients age 18 and older undergoing lumbar discectomy laminotomy surgery, the average change from pre-operative functional status to 3 months (6 to 20 weeks) post-operative functional status using the Oswestry Disability Index (ODI version 2.1a) patient reported outcome tool. Minnesota Community Measurement The average change (preoperative to 3 months post-operative) in functional status for all patients in the denominator. s There is not a traditional numerator for this measure; the measure is calculating the average change in functional status score from preoperative to post-operative functional status score. The measure is NOT aiming for a numerator target value for a post-operative ODI score. The average change is calculated as follows: Change is first calculated for each patient and then changed scores are summed and then an average is determined. Measure calculation takes into account those patients that have an improvement and those patients whose function decreases post-operatively. For example: Patient Pre-op ODI :I Post-op ODI :I Change in ODI Patient A: I 47 :I 18 :I 29 Patient B: I 45 :I 52 :I -7 Patient C: I 56 :I 12 :I 44 Patient D: I 62 :I 25 :I 37 Patient E: I 42 :I 57 :I -15 PatientF: I 51 :I 10 :I41 Patient G: I 62 :I 25 :I 37 Patient H: I 43 :I 20 :I 23 Patient I: I 74 :I 35 :I 39 Patient J: I 59 :I 23 :I 36 Average change in ODI 3 months post-op 26.4 points on a 100-point scale Eligible Population: Patients with lumbar discectomy laminotomy procedure (Single Disc-Lami Value Set) for a diagnosis of disc herniation (Disc Herniation Value Set)) occurring during a 12-month period for patients age 18 and older at the start of that period. Numerator: Denominator: Denominator: Patients within the eligible population whose functional status was measured by the Oswestry Disability Index, version 2.1a (ODI, v2.la) within 3 months preoperatively AND at 3 months (6 to 20 weeks) postoperatively. Exclusions: Measure Type: Measure Domain: High Priority Measure: Collection Type: Rationale: *The measure of average change in function can only be calculated if both a pre-operative and post-operative PRO assessment are completed. The following exclusions must be applied to the eligible population: Patient had any additional spine procedures performed on the same date as the lumbar discectomy laminotomy. Patient Reported Outcome Person and Caregiver-Centered Experience and Outcomes Yes (Patient Reported Outcome) MIPS CQMs Specifications We are adopting this measure because it measures an important patient reported outcome evaluating the functional status change from pre- to post-operative. The results of the measure can be used by clinicians in evaluating whether the patient's functional status has improved postoperatively. The MAP conditionally supported this measure pending NQF endorsement. While we agree with MAP that NQF endorsement of measures is preferred, NQF endorsement is not a requirement for measures to be considered for MIPS if the measure has an evidence-based focus. We believe this measure is evidence-based and is an important patient reported outcome. Note: Refer to the MAP Spreadsheet of Final Recommendations to CMS and HHS at httn://www.gualityforum.orglif_orkArea!Iinkit.asnx?Linkidentifier=id&ItemiD=86972. Comment: One commenter supported this new measure and applauded CMS for proposing to adopt four patient-reported outcome measures. They stated that patientreported outcomes reflect issues that are important to patients and provide a valuable perspective on care that cannot be obtained from other data sources (for example, severity of pain, physical functioning). Another commenter is pleased this measure emphasizes the change in functional status. Response: We thank the commenters for their support. Comment: One commenter recommended using the Patient-Reported Outcome Measurement Information System (PROMIS) as an alternative to the Oswestry Disability Index (ODI) as the functional status assessment basis for this quality measure. Response: The measure steward has developed and tested this measure using the ODI tool to assess the change in functional status. We do not believe that the PROMIS scale will add value to this quality measure. Rather, we believe that the addition of the PRO MIS scale introduces variability and would not provide a standardized tool to assess functional status. We do not own this measure and encourage the commenter to collaborate with the measure steward to expand the assessment tools. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00268 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.085</GPH> amozie on DSK3GDR082PROD with RULES3 Comment: One commenter did not support the addition of this measure, stating that the validity, reliability, and informativeness of PROMs are uncertain. Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60103 Category I Description Response: Although we agree PROMs can be challenging to implement, the measure steward has fully tested this measure for validity and reliability to obtain NQF endorsement. PROMs have been deemed one of our priorities as it is important to ensure patients are engaged in their care and are an important component in evaluating outcomes. Therefore, we respectfully disagree that PROMs are not informative for improving patient outcomes and clinician quality performance. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00269 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.086</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are finalizing the Average Change in Functional Status Following Lumbar Discectomy Laminotomy Surgery measure as proposed for the 2019 Performance Period and future years. 60104 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations A.5. Appropriate Use ofDXA Scans in Women Under 65 Years Who Do Not Meet the Risk Factor Profile for 0 steoporot1c . F racture Cate2ory Description Not Applicable (NA) NQF#: Quality#: 472 Percentage of female patients aged 50 to 64 without select risk factors for osteoporotic fracture who received an order for a dual-energy x-ray Description: absorptiometry (DXA) scan during the measurement period. Centers for Medicare & Medicaid Services Measure Steward: Female patients who received an order for at least one DXA scan in the measurement period. Numerator: Female patients ages 50 to 64 years with an encounter during the measurement period. Denominator: Exclude from the denominator patients with a combination of risk factors (as determined by age) or one of the independent risk factors: • Ages: 50-54 (>=4 combo risk factors) or I independent risk factor • Ages: 55-59 (>=3 combo risk factors) or I independent risk factor • Ages: 60-64 (>=2 combo risk factors) or 1 independent risk factor Combination risk factors (The following risk factors are all combination risk factors; they are grouped by when they occur in relation to the measurement period): The following risk factors may occur any time in the patient's history but must be active during the measurement period: • White (race) • BMI <= 20 kg/m2 (must be the first BMI of the measurement period) • Smoker (current during the measurement period) • Alcohol consumption(> two units per day (one unit is 12 oz. of beer, 4 oz. of wine, or I oz. of liquor)) The following risk factor may occur any time in the patient's history and must not start during the measurement period: • Osteopenia The following risk factors may occur at any time in the patient's history or during the measurement period: • Rheumatoid arthritis • Hyperthyroidism • Malabsorption syndromes: celiac disease, inflammatory bowel disease, ulcerative colitis, Crohn's disease, cystic fibrosis, malabsorption • Chronic liver disease • Chronic malnutrition The following risk factors may occur any time in the patient's history and do not need to be active at the start of the measurement period: • Documentation of history of hip fracture in parent • Osteoporotic fracture • Glucocorticoids (>= 5 mg/per day) [cumulative medication duration >= 90 days] Exclusions: Independent risk factors (The following risk factors are all independent risk factors; they are grouped by when they occur in relation to the measurement period): The following risk factors may occur at any time in the patient's history and must not start during the measurement period: • Osteoporosis The following risk factors may occur at any time in the patient's history prior to the start of the measurement period, but do not need to be active during the measurement period: • Gastric bypass • FRAX[R]1 0-year probability of all major osteoporosis related fracture >= 9.3 percent • Aromatase inhibitors amozie on DSK3GDR082PROD with RULES3 Rationale: VerDate Sep<11>2014 Yes (Appropriate Use) eCQM Specifications We are adopting this measure because it will serve as a counterbalance to the existing measure of appropriate use (that is, Screening for Osteoporosis for Women Aged 65-85 Years of Age (Quality ID #039)). This measure addresses the inappropriate use ofDXA scans for 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00270 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.087</GPH> Measure Type: Measure Domain: High Priority measure: Collection Type: The following risk factors may occur at any time in the patient's history or during the measurement period: • Type I diabetes • End stage renal disease • Osteogenesis imperfecta • Ankylosing spondylitis • Psoriatic arthritis • Ehlers-Danlos syndrome • Cushing's syndrome • Hyperparathyroidism • Marfan syndrome • Lupus Process Efficiency and Cost Reduction Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations Category 60105 Description women age 50-64 years without risk factors for osteoporosis. The MAP recognized the need for early detection of osteoporosis but reiterated the importance of appropriate use of this screening technique and noted this measure could be complementary to the existing osteoporosis screening measure (Quality ID #039). The MAP recognized the potential need for a balancing measure to prevent the potential underuse of DXA scans. The MAP conditionally supported this measure pending NQF endorsement. While we agree with MAP that NQF endorsement of measures is preferred, it is not a requirement for measures to be considered for MIPS if the measure has an evidence-based focus. We believe this measure is evidence-based and is an important patient reported outcome. Note: Refer to the MAP Spreadsheet of Final Recommendations to CMS and HHS at htto://www.oualitvforum.org/WorkArea/linkit.asox?Linkldentifier=id&ltemiD=86972. Comment: One commenter supported the addition of this measure. Response: We thank the commenter for their support. Comment: One commenter expressed that clinicians may not be aware of the distinction between screening DXA scans and those appropriately performed as medically necessary follow-up care in a diagnosed individual to ascertain response to pharmacological interventions. The commenter urged CMS to clarizy this distinction within its final rule and consider augmenting the pharmacologic therapy quality measure with a subpart that captures appropriate DXA re-testing to ascertain response to treatment. A second commenter urged CMS to defer implementing any quality measures that might deter osteoporosis screening until most men and women who are at heightened risk of fragility fractures receive testing and pharmacotherapy within the standard of care. Response: Thank you for your comment and support of the DXA screening measure. We affirm that the intent of this measure is to encourage screening in the population at greatest risk for osteoporosis and assess progress toward appropriate screening. We appreciate your suggestion for an additional measure on appropriate screening as a follow-up to pharmacologic therapy in the treatment of osteoporosis and will give consideration to developing such a measure. This measure includes a number of applicable risk factors that would remove the at-risk patient from the denominator. The intended patient population is not considered high risk where a DXA scan is not appropriate. This measure does not deter appropriate osteoporotic screening for patients that meet the risks factors. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00271 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.088</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are fmalizing the Appropriate Use ofDXA Scans in Women Under 65 Years Who Do Not Meet the Risk Factor Profile for Osteoporotic Fracture measure as proposed for the 2019 Performance Period and future years. 60106 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations .. Category NQF#: Quality#: Description: Measure Steward: s . Leg p·Fn spme F USIOD urgery A6Average Ch angem am o owmg L urn b ar S. Description Not Applicable (NA) 473 For patients age 18 and older undergoing lumbar spine fusion surgery, the average change from pre-operative leg pain to I year (9 to 15 months) post-operative leg pain using the Visual Analog Scale (VAS) patient reported outcome tool. Minnesota Community Measurement The average change (preoperative to 1 year post-operative) in leg pain for all patients in the denominator. There is not a traditional numerator for this measure; the measure is calculating the average change in leg pain score from pre-operative to post-operative leg pain score. The measure is NOT aiming for a numerator target value for a post-operative pain score. The average change is calculated as follows: Change is first calculated for each patient and then changed scores are summed and then an average is determined. Measure calculation takes into account those patients that have an improvement and those patients whose pain increases post-operatively. Patient I: Pre-op VAS I: Po st-op VAS I:(Pre-op minus Post-op) For example: Patient A: I: 8.5 I: 3.5 I: 5.0 Patient F I: 7.5 I: 1.5 I: 6.0 Patient G I: 9.0 I: 4.5 I: 4.5 Patient B: I: 9.0 I: 2.5 I: 6.5 Patient HI: 5.5 I: 7.5 I: -2.0 Patient C: I: 7.0 I: 0.5 I: 6.5 Patient I I: 9.0 I: 5.0 I: 4.0 Patient D: I: 6.5 I: 8.0 I: -1.5 Patient E I: 8.5 I: 2.0 I: 6.5 Patient J I: 7.0 I: 2.5 I: 4.5 Average change in VAS points 4.0 Average change in leg pain 1 year post-op 4.0 points on a 10 point scale. Eligible Population: Patients with lumbar spine fusion procedures (Arthrodesis Value Set) occurring during a 12-month period for patients age 18 and older at the start of that period. Numerator: Denominator: Patients within the eligible population whose leg pain was measured by the Visual Analog Scale (VAS) within 3 months preoperatively AND at 1 year(+/- 3 months) postoperatively. Denominator: Exclusions: Measure Type: Measure Domain: High priority measure: Collection Type: Rationale: *The measure of average change in function can only be calculated if both a pre-operative and post-operative PRO assessment are completed The following exclusions must be applied to the eligible population: Patient had cancer (Spine Cancer Value Set), fracture (Spine Fracture Value Set) or infection (Spine Infection Value Set) related to the spine. Patient had idiopathic or congenital scoliosis (Congenital Scoliosis Value Set) Patient Reported Outcome Person and Caregiver-Centered Experience and Outcomes Yes (Patient Reported Outcome) MIPS CQMs Specifications We are adopting this measure because it evaluates the management of pain from pre- to post-operative, which represents an important patient reported outcome. The results can be used by clinicians in evaluating whether the patient's pain has reduced post-operatively. The MAP conditionally supported this measure pending NQF endorsement. While we agree with MAP that NQF endorsement of measures is preferred, it is not a requirement for measures to be considered for MIPS if the measure has an evidence-based focus. We believe this measure is evidence-based and is an important patient reported outcome. Note: Refer to the MAP Spreadsheet of Final Recommendations to CMS and HHS at htto:l/www .cmalitvforum.org/WorkArea/linkit.asox?Linkldentifier=id&ltem!D=86972. Comment: One commenter supported this new measure and applauded CMS for proposing to adopt four patient-reported outcome measures. The commenter stated that patient-reported outcomes reflect issues that are important to patients and provide a valuable perspective on care that cannot be obtained from other data sources (for example, severity of pain, physical functioning). Response: We thaulc the commenter for their support. Comment: One commenter did not support the addition of this measure, stating that the validity, reliability, and informativeness of PROMs are uncertain. Response: Although we agree PROMs can be challenging to implement, the measure steward has fully tested this measure for validity and reliability to obtain NQF endorsement. PROMs have been deemed one of our priorities as it is important to ensure patients are engaged in their care and are an important component in evaluating outcomes. Therefore, we respectfully disagree that PROMs are not informative for improving patient outcomes and clinician quality performance. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00272 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.089</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are fmalizing the Average Change in Leg Pain Following Lumbar Spine Fusion Surgery measure as proposed for the 2019 Performance Period and future years. Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60107 .. . Iate et M ed"IcatJon A 7 I sc h ernie . V ascu ar D"1sease u se ofA sp1rm or A nti-p1 Category NQF#: Qnality #: Description: Measnre Steward: Nnmerator: Denominator: Exclnsions: Measnre Type: Measnre Domain: High priority measnre: Collection Type: Rationale: Description Not Applicable (NA) Not Applicable (N/A) The percentage of patients 18-75 years of age who had a diagnosis of ischemic vascular disease (IVD) and were on daily aspirin or antiplatelet medication, unless allowed contraindications or exceptions are present. Minnesota Community Measurement Denominator patients with documentation that the patient was on daily aspirin or anti-platelet medication during the measurement period, unless allowed contraindications or exceptions are present. 18 years or older at the start of the measurement period AND less than 76 years at the end of the measurement period. AND Patient had a diagnosis of ischemic vascular disease (Ischemic Vascular Disease Value Set) with any contact during the current or prior measurement period OR had ischemic vascular disease (Ischemic Vascular Disease Value Set) present on an active problem list at any time during the measurement period. AND At least one established patient office visit (Established Pt Diabetes & Vase Value Set) for any reason during the measurement period The following exclusions are allowed to be applied to the eligible population: • Patient was a permanent nursing home resident at any time during the measurement period. • Patient was in hospice or receiving palliative care at any time during the measurement period. • Patient died prior to the end of the measurement period. • Patient had only urgent care visits during the measurement period. Process Effective Clinical Care No Medicare Part B Claims Measure Specifications, MIPS CQMs Specifications We proposed this measure because the measure exclusions are more appropriate than those in the currently adopted Ischemic Vascular Disease (IVD): Use of Aspirin or Another Antithrombotic (Quality ID #204) measure. The measure accounts for history of gastrointestinal bleeding, intracranial bleeding, bleeding disorder, allergy to aspirin or anti-platelets, or use of non-steroidal anti-inflammatory agents. The MAP acknowledged both that clinicians may still report Aspirin or Anti-platelet Medication measures separately from the composite to drive quality improvement. The MAP conditionally supported this measure with the condition that there are no competing measures in the program. We refer readers to Table C where we are removing Ischemic Vascular Disease (IVD): Use of Aspirin or Another Antithrombotic (Quality ID #204). Note: Refer to the MAP Spreadsheet of Final Recommendations to CMS and HHS at htto://www.aualitvforum.onz./WorkArea!linkit.asox?Linkidentifier=id&ItemiD=86972. Comment: A commenter recommended utilizing the Core Quality Measure Collaborative (CQMC) to evaluate both the Ischemic Vascular Disease (IVD): Use of Aspirin or Another Antiplatelet measure and the measure CMS proposed to replace it with a new measure: Ischemic Vascular Disease: Use of Aspirin or Antiplatelet Medication, during their maintenance review of the ACO/PMHIPC Core Measure Set. This will allow payers, clinicians, and other stakeholders to weigh in on the measures' exclusion criteria and other characteristics. Another commenter encouraged CMS to continue alignment of the MIPS measure set with those recommended by the CQMC. Another commenter opposed the proposed adoption of this measure because they believe that it is already captured in the Q441: Ischemic Vascular Disease (IVD) Ail or None Outcome Measure (Optimal Control) measure and recommended not including such a measure in the program where it could displace reporting of the higher-value composite measure. Response: We appreciate the suggestion to allow stakeholders to weigh in on the exclusion criteria; however, we do not steward either of the measures and may not have the flexibility to revise the measures based on payers, clinicians or other stakeholders' feedback. Engaging the CQMC is beneficial to obtaining stakeholder feedback, but we encourage the commenter to provide this feedback to the CQMC. We are aware that this new measure is captured in the composite measure Q441 and that the composite measure is more robust. Although we believe Q441 may be burdensome to some eligible clinicians, we also believe it is a more meaningful measure than this new IVD measure. Therefore, to be consistent with our policy to remove measures that are duplicative to other measures and to ensure measures are more meaningful, we have decided to not fmalize inclusion of this new IVD measure. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00273 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.090</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are not finalizing the Ischemic Vascular Disease Use ofAspirin or Anti-platelet Medication measure as proposed for the 2019 Performance Period. 60108 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations A.8. Zoster (Shingles) Vaccination Cate2ory NQF#: Quality#: Description: Measure Steward: Numerator: Denominator: Exclusions: Measure Type: Measure Domain: High priority measure: Collection Type: Rationale: Description Not Applicable (NA) 474 The percentage of patients 50 years of age and older who have a Varicella Zoster (shingles) vaccination. PPRNet Patients with a shingles vaccine ever recorded. Patients 50 years of age and older. None Process Cormnunity/Population Health No MIPS CQMs Specifications We are adopting this measure because there are no measures currently in MIPS that address shingles vaccination for patients 50 years and older as recormnended by the CDC. The MAP concluded that this measure would address the important topic of adult irmnunization. It discussed the new guidelines under development for the Zoster vaccination that could impact the amount of doses, the age of administration, and the specific vaccine that is used, but also noted that guidelines are constantly evolving and measures should be routinely updated based on changing guidelines. The MAP conditionally supported this measure pending NQF endorsement, and specifically requested evaluating the measure to ensure it has appropriate exclusions and reflects the most current CDC guidelines given the concerns about the cost of the vaccine and potential concerns about administering to irmnunocompromised patients. While we agree with MAP that NQF endorsement of measures is preferred, it is not a requirement for measures to be considered for MIPS if the measure has an evidence-based focus. We believe this measure is evidence-based and is an important patient reported outcome. Note: Refer to the MAP Spreadsheet of Final Recormnendations to CMS and HHS at htto://www.aualitvforum.org/WorkArea!linkit.asox?Linkidentifier=id&ItemiD=86972. Comment: One cormnenter did not support the proposed adoption of this measure because it needs to be updated to reflect the most recent clinical guidelines. Response: The measure steward has aligned this measure with the most current clinical guidelines and it will be implemented as such. As indicated in our rationale, the measure will address the impacts to the amount of doses, the age of administration and the specific vaccine utilized. This measure addresses an important gap in adult immunization. Comment: Several commenters noted that the proposed rule rationale of"60 years and older" should be "50 years and older." Response: We thank the cormnenters for their concerns regarding the age criteria with the rationale. The correct age was included in the description and denominator within the proposed rule, but did not align with the rationale. We agree with the denominator including patients over the age of 50 years and aligned the rationale with the measure's age criteria. Comment: One cormnenter supported the proposed new measure for Zoster (Shingles) Vaccination. The commenter also supported broader adoption of a herpes zoster measure across specialty sets to reduce the number of missed irmnunization opportunities for this debilitating condition. The commenter supported the alignment of reporting mechanisms and believed doing so will strengthen and enhance the development and implementation of adult immunization quality measures. Response: We thank the cormnenter for their support of the new measure, Zoster (Shingles) Vaccination. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00274 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.091</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are fmalizing the Zoster (Shingles) Vaccination measure as proposed for the 2019 Performance Period and future years. The rationale is updated to state "patients 50 years and older" which aligns with the description and denominator age criteria. Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60109 .. A9HIVS creemne; Cate2ory NQF#: Quality#: Description: Measure Steward: Numerator: Denominator: Exclusions: Measure Type: Measure Domain: High priority measure: Collection Type: Rationale: Description Not Applicable (NA) 475 Percentage of patients 15-65 years of age who have ever been tested for human immunodeficiency virus (HIV). Centers for Disease Control and Prevention Patients with documentation of the occurrence of an HIV test between their 15th and 66th birthdays and before the end of the measurement period. Patients 15 to 65 years of age who had an outpatient visit during the measurement period. Patients diagnosed with HIV prior to the start of the measurement period. Process Community/Population Health No eCQM Specifications We are adopting this measure because HIV screening is a national and global priority. While there are three currently adopted HIV measures in MIPS, they do not include screening the general population. The MAP acknowledged the importance ofHIV screening from a population health perspective, but also questioned whether encouraging HIV screening through the MIPS program is the most effective strategy for improving this population health goal. It also expressed concern about how this measure under consideration identified individuals who may have a HIV screening in the community. Additionally, several MAP members expressed concern regarding the specifications requiring one time lifetime screening. The MAP conditionally supported this measure pending NQF endorsement. While we agree with MAP that NQF endorsement of measures is preferred, it is not a requirement for measures to be considered for MIPS if the measure has an evidence-based focus. We believe this measure is evidence-based and is an important patient reported outcome. Note: Refer to the MAP Spreadsheet of Final Recommendations to CMS and HHS at httn://www.aualitvforum.ondWorkAreallinkit.asnx?Linkldentifier=id&ItemiD=86972. Comment: One commenter did not support the proposed adoption of this measure because they stated that there is no demonstrated performance gap (measure testing results showed very high performance overall) and the measure still needs to be tested at the clinician-level. Response: We believe it is important to implement an HIV screening measure as it addresses an important national and global priority. This measure has been developed as an eCQM Specification and should have little burden in the submission of this measure. The version of this measure proposed has been tested at the clinician-level. The measure steward developed and tested a previous version of this measure at the community center-level. The NQF Health and Well-Being 2015-2017 Committee reviewed this facility-level version of the measure and voted to pass the measure on evidence and performance gap, but decided the measure did not meet the scientific acceptability criteria. The NQF standing committee noted that when this previous version of the measure was tested at the facility-level a performance gap was demonstrated, performance at four community health centers ranged from 20.6 to 31.1 percent and performance at a fifth community health center serving a high-risk population was 65.3 percent (NQF, Health and Well-Being 2015-2017: Technical Report, Aprill7, 2017, h!!I1://www.guali:tyforum.org/Projects/h/Health and Well Being 2015-20 17/Final ReJ2ort.asQx). Since then, the measure steward modified the measure and tested it at the clinician-level. As we indicated in our proposal, the MAP reviewed this clinician-level version of the measure in 2018 and conditionally supported it pending NQF review and endorsement. The steward plans to seek NQF endorsement on this clinician-level measure. We believe implementing this measure at the clinician-level will raise awareness and improve patient care leading to improvement in population health. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00275 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.092</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are fmalizing the HIV Screening measure as proposed for the 2019 Performance Period and future years. 60110 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations A 10 F a II s: Screenme;, R'IS kA - ssessment, an dPI an ofC are to p revent F uture Fll a s Cate2ory NQF#: Quality#: Description: Measure Steward: Description 0101 Not Applicable (N/A) This is a clinical process measure that assesses falls prevention in older adults. The measure has three rates: Screening for Future Fall Risk: Percentage of patients aged 65 years and older who were screened for future fall risk at least once within 12 months. Falls Risk Assessment: Percentage of patients aged 65 years and older with a history of falls who had a risk assessment for falls completed within 12 months. Plan of Care for Falls: Percentage of patients aged 65 years and older with a history of falls who had a plan of care for falls documented within 12 months. National Committee for Quality Assurance This measure has three rates. The numerators for the three rates are as follows: A) Screening for Future Fall Risk: Patients who were screened for future fall* risk** at last once within 12 months. B) Falls Risk Assessment: Patients who had a risk assessment*** for falls completed within 12 months. C) Plan of Care for Falls: Patients with a plan of care**** for falls documented within 12 months. *A fall is defined as a sudden, unintentional change in position causing an individual to land at a lower level, on an object, the floor, or the ground, other than as a consequence of a sudden onset of paralysis, epileptic seizure, or overwhelming external force. Numerator: **Risk of future falls is defined as having had had 2 or more falls in the past year or any fall with injury in the past year. ***Risk assessment is comprised of balance/gait assessment AND one or more of the following assessments: postural blood pressure, vision, home fall hazards, and documentation on whether medications are a contributing factor or not to falls within the past 12 months. ****Plan of care must include consideration of vitamin D supplementation AND balance, strength and gait training. A) Screening for Future Fall Risk: All patients aged 65 years and older seen by an eligible provider in the past year. Denominator: Exclusions: Measure Type: Measure Domain: High Priority Measure: Collection Type: B & C) Falls Risk Assessment & Plan of Care for Falls: All patients aged 65 years and older seen by an eligible provider in the past year with a history of falls (history of falls is defined as 2 or more falls in the past year or any fall with injury in the past year). Patients who have documentation of medical reason(s) for not screening for future fall risk, undergoing a risk-assessment or having a plan of care (for example, patient is not ambulatory) are excluded from this measure. Process Patient Safety Yes Medicare Part B Claims Measure Specifications, CMS Web Interface Measure Specifications, MIPS CQMs Specifications We are adopting this measure because it is a combined version of three of the currently adopted measures 154: Falls: Risk Assessment, 155: Falls: Plan of Care and 318: Falls: Screening for Future Fall Risk. The new combined Falls measure (based on specifications in NQF 0101) is more robust and will include strata components for Future Falls Risk, Falls Risk Assessment, and Falls Risk Plan of Care which creates a more comprehensive screening measure. As noted in Table C, we are proposing to remove 154: Falls: Risk Assessment, 155: Rationale: Falls: Plan of Care and 318: Falls: Screening for Future Fall Risk because they will be subsumed by this new measure. While we note that has not been put forth through the MAP for consideration in MIPS, the three individual measures have been NQF endorsed as one measure. Comment: We received a number of comments opposing the new composite measure. Comments included a need for more clinical review, that vendors need time to develop and certify the respective replacement measures, and that CMS does not describe a benchmark for the composite measure. Several commenters were in support of the new composite measure stating that that it is a more robust and more comprehensive screening measure. Response: We thank all ofthe commenters for expressing the opposition of combining three measures to create a composite measure. We agree with the feedback provided and will postpone the implementation of the Falls: Screening, Risk-Assessment, and Plan of Care to Prevent Future Falls measure until the measure can be fully vetted to utilize standardized tools that would appropriately identify the at-risk patient population. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00276 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.093</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are not fmalizing the Falls: Screening, Risk-Assessment, and Plan of Care to Prevent Future Falls measure for the 2019 Performance Period. Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60111 TABLE Group B: Finalized New and Modified MIPS Specialty Measure Sets for the 2021 MIPS Payment Year and Future Years Note: In the CY 2019 PFS proposed rule (83 FR 35704), we proposed to modify the specialty measure sets below based upon review of updates made to existing quality measure specifications, the proposal of adding new measures for inclusion in MIPS, and the feedback provided by specialty societies. In the first column, existing measures with substantive changes are noted with an asterisk(*), core measures that align with Core Quality Measure Collaborative (CQMC) core measure set(s) are noted with the symbol (§) and high priority measures are noted with an exclamation point (!). In addition, the Indicator column includes a "high priority type" in parentheses after each high priority indicator(!) to fully represent the regulatory definition of high priority measures. As discussed in section 111.1.3 .h.(2)(b)(i) of this final rule, we are amending the definition of high priority at §414.1305 to include opioid-related measures. We define high priority measure to mean an outcome, appropriate use, patient safety, efficiency, patient experience, care coordination, or opioid-related quality measure. Outcome measures include outcome, intermediate outcome, and patient reported outcome. A high priority indicator (an exclamation point(!)) in the Indicator column has been added for all opioid-related measures. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00277 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.094</GPH> amozie on DSK3GDR082PROD with RULES3 The following specialty measure sets have been excluded from this final rule, because we did not propose any changes to these sets: Allergy/Immunology, Electro-Physiology Cardiac Specialist, Plastic Surgery, Interventional Radiology, Dentistry and Hospitalists. Therefore, we refer readers to these finalized specialty sets in the CY 2018 Quality Payment Program final rule (82 FR 53976 through 54146). Note: In the proposed rule, we inadvertently included the Dentistry specialty set even though no changes were proposed for this specialty set; therefore, we removed the Dentistry specialty set from this final rule because we did not receive any comments specific to the Dentistry specialty set from previous final rules or the proposed rule. 60112 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.l. Anesthesiology In addition to the considerations discussed in the introductory language of Table Bin this final rule, the Anesthesiology specialty set takes into consideration the following criteria, which includes, but is not limited to: the measure reflects current clinical guidelines and the coding of the measure includes the specialists. We may reassess the appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. In addition, as outlined at the end of this table, we removed the following quality measures from the specialty set: Quality IDs: 426 and 427. B.l. Anesthesiology 0236 044 N/A MIPSCQMs Specifications Process Effective Clinical Care Process Patient Safety NIA 076 NIA Medicare Part BClaims Measure Specifications, MIPSCQMs Specifications ! (Outcome) N/A 404 N/A MIPSCQMs Specifications Intermedi ate Outcome Effective Clinical Care ! (Outcome) 2681 424 NIA MIPSCQMs Specifications Outcome Patient Safety ! (Patient Safety) N/A 430 N/A MIPSCQMs Specifications Process Patient Safety 463 NIA MIPSCQMs Specifications Process Effective Clinical Care ! (Patient Safety) Coronary Artery Bypass Graft (CABG): Preoperative Beta-Blocker in Patients with Isolated CABG Surgery: Percentage of isolated Coronary Artery Bypass Graft (CABG) surgeries for patients aged 18 years and older who received a beta-blocker within 24 hours prior to surgical incision. Prevention of Central Venous Catheter (CVC)-Related Bloodstream Infections: Percentage of patients, regardless of age, who undergo central venous catheter (CVC) insertion for whom eve was inserted with all elements of maximal sterile barrier technique, hand hygiene, skin preparation and, if ultrasound is used, sterile ultrasound followed. Anesthesiology Smoking Abstinence: percentage of current smokers who abstain from cigarettes prior to anesthesia on the day of elective Perioperative Temperature Management: Percentage of patients, regardless of age, who undergo surgical or therapeutic procedures under general or neuraxial anesthesia of 60 minutes duration or longer for whom at least one body temperature greater than or equal to 35. 5 degrees Celsius (or 95.9 degrees Fahrenheit) was achieved within the 30 minutes immediately before or the 15 minutes immediately after anesthesia end time. Prevention of Post-Operative Nausea and Vomiting (PONV)- Combination Therapy: Percentage of patients, aged 18 years and older, who undergo a procedure under an inhalational general anesthetic, AND who have three or more risk factors for post-operative nausea and vomiting (PONV), who receive combination therapy consisting of at least two prophylactic pharmacologic antiemetic agents of different . . classes Prevention of Post-Operative Vomiting (POV) -Combination Therapy (Pediatrics): Percentage of patients aged 3 through 17 years of age, who undergo a procedure under general anesthesia in which an inhalational anesthetic is used for maintenance AND who have two or more risk factors for post-operative vomiting (POV), who receive combination therapy consisting of at least two prophylactic pharmacologic anti-emetic agents of different Centers for Medicare& Medicaid Services American Society of Anesthesiologists American Society of Anesthesiologists American Society of Anesthesiologists American Society of Anesthesiologists American Society of Anesthesiologists VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00278 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.095</GPH> amozie on DSK3GDR082PROD with RULES3 We did not receive specific comments regarding the measures included in this specialty measure set. Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60113 B.l. Anesthesiology (continued) NIA N/A 426 427 NIA N/A MIPS CQMs Specificat ions MIPS CQMs Specificat ions Process Process Communic ation and Care Coordinati on Post-Anesthetic Transfer of Care Measure: Procedure Room to a Post Anesthesia Care Unit (PACU): Percentage of patients, regardless of age, who are under the care of an anesthesia practitioner and are admitted to a PACU or other non-ICU location in which a post-anesthetic formal transfer of care protocol or checklist which includes the key transfer of care elements is utilized. Communic ation and Care Coordinati on Post-Anesthetic Transfer of Care: Use of Checklist or Protocol for Direct Transfer of Care from Procedure Room to Intensive Care Unit (ICU): Percentage of patients, regardless of age, who undergo a procedure under anesthesia American and are admitted to an Intensive Care Unit Society of (I CU) directly from the anesthetizing Anesthesiologists location, who have a documented use of a checklist or protocol for the transfer of care from the responsible anesthesia practitioner to the responsible ICU team or team member. American Society of Anesthesiologists This measure is removed from the 2019 program based on the detailed rationale described below for this measure in "Table C: Quality Measures Finalized for Removal in the 2021 MIPS Payment Year and Future." This measure is removed from the 2019 program based on the detailed rationale described below for this measure in "Table C: Quality Measures Finalized for Removal in the 2021 MIPS Payment Year and Future Years." We did not receive specific comments regarding the proposed removal of measures from this specialty measure set. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00279 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.096</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are finalizing the removal of measures from the Anesthesiology Specialty Measure Set as proposed for the 2019 Performance Period and future 60114 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.2. Cardiology In addition to the considerations discussed in the introductory language of Table Bin this final rule, the Cardiology specialty set takes into consideration the following criteria, which includes, but is not limited to: the measure reflects current clinical guidelines and the coding of the measure includes the specialists. We may reassess the appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. In addition, as outlined at the end of this table, we removed the following quality measures from the specialty set: Quality IDs: 204 and 373. B.2. Cardiology 0081 005 CMSI35 v7 § 0067 006 NIA MIPSCQMs Specifications § 0070 007 CMS145 v7 eCQM Specifications, MIPSCQMs Specifications eCQM Specifications, MIPSCQMs Specifications § 0083 008 CMS144 v7 ! (Care Coordination) 0326 047 N/A Medicare Part BClaims Measure Specifications, MIPSCQMs Specifications Process Effective Clinical Care Process Effective Clinical Care Process Process Process amozie on DSK3GDR082PROD with RULES3 Specifications VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00280 Effective Clinical Care Effective Clinical Care Communicati on and Care Coordination Clinical Care Fmt 4701 Coronary Artery Disease (CAD): Beta-Blocker Therapy-Prior Myocardial Infarction (MI) or Left Ventricular Systolic Dysfunction (LVEF <40 percent): Percentage of patients aged 18 years and older with a diagnosis of coronary artery disease seen within a 12-month period who also have prior MI OR a current or prior LVEF < 40 percent who were beta-blocker Heart Beta-Blocker Therapy Left Ventricular Systolic Dysfunction (LVSD): Percentage of patients aged 18 years and older with a diagnosis of heart failure (HF) with a current or prior left ventricular ejection fraction (L VEF) < 40 percent who were prescribed betablocker therapy either within a 12-month period when seen in the outpatient setting OR at each Sfmt 4725 Advance Care Plan: Percentage of patients aged 65 years and older who have an advance care plan or surrogate decision maker documented in the medical record or documentation in the medical record that an advance care plan was discussed but the patient did not wish or was not able to name a surrogate decision maker or provide an advance care Chronic Stable Coronary Artery Disease: ACE Inhibitor or ARB Therapy--Diabetes or Left Ventricular Systolic Dysfunction (LVEF <40%): Percentage of patients aged 18 years and older with a diagnosis of coronary artery disease seen within a 12-month period who also have diabetes OR a current or prior Left Ventricular Ejection Fraction (L VEF) < 40 percent who were ACE inhibitor or ARB E:\FR\FM\23NOR3.SGM 23NOR3 Physician Consortium Performance Improvement Foundation (PCPI®) American Heart Association Physician Consortium Performance Improvement Foundation (PCPI®) Physician Consortium Performance Improvement Foundation (PCPI®) National Committee for Quality Assurance Heart Association ER23NO18.097</GPH> § eCQM Specifications, MIPSCQMs Specifications Heart Failure (HF): Angiotensin-Converting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) Therapy for Left Ventricular Systolic Dysfunction (LVSD): Percentage of patients aged 18 years and older with a diagnosis of heart failure (HF) with a current or prior left ventricular ejection fraction (L VEF) < 40 percent who were prescribed ACE inhibitor or ARB therapy either within a 12month period when seen in the outpatient setting OR at each Chronic Stable Coronary Artery Disease: Antiplatelet Therapy: Percentage of patients aged 18 years and older with a diagnosis of coronary artery disease (CAD) seen within a 12-month period who were Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60115 B.2. Cardiology 0419 130 BClaims Measure Specifications, eCQM Specifications, MIPSCQMs Specifications CMS68v 8 Medicare Part BClaims Measure Specifications, eCQM Specifications, MIPSCQMs Specifications Process Part BClaims Measure Specifications, eCQM Specifications, CMSWeb Interface Measure Specifications, MIPSCQMs Specifications Process v7 Medicare& Medicaid Services Patient Safety Documentation of Current Medications in the Medical Record: Percentage of visits for patients aged 18 years and older for which the eligible professional or eligible clinician attests to documenting a list of current medications using all innnediate resources available on the date of the encounter. This list must include ALL known prescriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutritional) supplements AND must contain the medications' name, and route of administration. Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: a. Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months. b. Percentage of patients aged 18 years and older who were screened for tobacco use and identified as a tobacco user who received tobacco cessation intervention. c. Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as Centers for Medicare& Medicaid Services Population Health Consortium Performance Improvement Foundation (PCPI®) 236 CMS165 v7 Medicare Part BClaims Measure Specifications, eCQM Specifications, CMSWeb Interface Measure Specifications, MIPSCQMs Intermediate Outcome Effective Clinical Care Controlling High Blood Pressure: Percentage of patients 18-85 years of age who had a diagnosis of hypertension and whose blood pressure was adequately controlled ( <140/90 mmHg) during the measurement period. National Committee for Quality Assurance 0022 238 CMS156 v7 eCQM Specifications, MIPSCQMs Specifications Process Patient Safety Use of High-Risk Medications in the Elderly: Percentage of patients 65 years of age and older who were ordered high-risk medications. Two rates are reported. a. Percentage of patients who were ordered at least one high-risk medication. b. Percentage of patients who were ordered at National Committee for Quality Assurance ! (Patient Safety) amozie on DSK3GDR082PROD with RULES3 Index (BMI) Screening and Follow-Up Plan: Percentage of patients aged 18 years and older with a BMI documented during the current encounter or during the previous 12 months AND with a BMI outside of normal parameters, a follow-up plan is documented during the encounter or during the previons 12 months of the current encounter. Normal Parameters: Age 18 years and older BMI => 18.5 and< 25 0018 ! (Outcome) VerDate Sep<11>2014 Population Health 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00281 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.098</GPH> ! (Patient Safety) 7 60116 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.2. Cardiology 243 N/A MIPSCQMs Specifications Process Communicati on and Care Coordination N/A 317 CMS22v 7 Medicare Part BClaims Measure Specifications, eCQM Specifications, MIPSCQMs Process Community/ Population Health ! (Efficiency) N/A 322 N/A MIPSCQMs Specifications Efficiency Efficiency and Cost Reduction ! (Efficiency) N/A 323 N/A MIPSCQMs Specifications Efficiency Efficiency and Cost Reduction (Efficiency) Specifications amozie on DSK3GDR082PROD with RULES3 1525 VerDate Sep<11>2014 326 19:26 Nov 21, 2018 N/A Jkt 247001 Medicare Part BClaims Measure Specifications, MIPS PO 00000 and Cost Reduction Process Frm 00282 Fmt 4701 Effective Clinical Care Sfmt 4725 Cardiac Rehabilitation Patient Referral from an Outpatient Setting: Percentage of patients evaluated in an outpatient setting who within the previous 12 months have experienced an acute myocardial infarction (MI), coronary artery bypass graft (CABG) surgery, a percutaneous coronary intervention (PCI), cardiac valve surgery, or cardiac transplantation, or who have chronic stable angina (CSA) and have not already participated in an early outpatient cardiac rehabilitation/secondary prevention (CR) program for the qualifying event/diagnosis who were referred to a CR Preventive Care and Screening: Screening for High Blood Pressure aud Follow-Up Documented: Percentage of patients aged 18 years and older seen during the reporting period who were screened for high blood pressure AND a recommended follow-up plan is documented American Heart Association Cardiac Stress Imaging Not Meeting Appropriate Use Criteria: Preoperative Evaluation in Low-Risk Surgery Patients: Percentage of stress single-photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI), stress echocardiogram (ECHO), cardiac computed tomography angiography (CCTA), or cardiac magnetic resonance (CMR) performed in low risk surgery patients 18 years or older for preoperative evaluation the 12-month Cardiac Stress Imaging Not Meeting Appropriate Use Criteria: Routine Testing After Percutaneous Coronary Intervention (PCI): Percentage of all stress single-photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI), stress echocardiogram (ECHO), cardiac computed tomography angiography (CCTA), and cardiovascular magnetic resonance (CMR) performed in patients aged 18 years and older routinely after percutaneous coronary intervention (PCI), with reference to timing of test after PCI and symptom status. Cardiac Stress Imaging Not Meeting Appropriate Use Criteria: Testing in Asymptomatic, Low-Risk Patients: Percentage of all stress single-photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI), stress echocardiogram (ECHO), cardiac computed tomography angiography (CCTA), and cardiovascular magnetic resonance (CMR) performed in asymptomatic, low coronary heart disease (CHD) risk patients 18 years and older for initial detection and risk assessment. Atrial Fibrillation and Atrial Flutter: Chronic Anticoagulation Therapy: Percentage of patients aged 18 years and older with a diagnosis ofnonvalvular atrial fibrillation (AF) or atrial flutter whose assessment of the American College of Cardiology E:\FR\FM\23NOR3.SGM 23NOR3 Centers for Medicare& Medicaid Services American College of Cardiology College of Cardiology American Heart Association ER23NO18.099</GPH> 0643 ! (Care Coordination) Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60117 B.2. Cardiology ! (Outcome) N/A 344 N/A MIPSCQMs Specifications Outcome Effective Clinical Care ! (Outcome) 1543 345 N/A MIPSCQMs Specifications Outcome Effective Clinical Care ! (Care Coordination) N/A 374 CMS50v 7 eCQM Specifications, MIPSCQMs Specifications Process Comrnunicati on and Care Coordination MIPSCQMs Specifications Process N/A MIPSCQMs Specifications Process v2 Specifications, CMSWeb Interface Measure Specifications, MIPSCQMs Specifications N/A MIPSCQMs Specifications A 2152 431 Population Health Population/ Community Process N/A 441 ! (Outcome) amozie on DSK3GDR082PROD with RULES3 thromboembolic risk factors indicate one or more high-risk factors or more than one moderate risk factor, as determined by CHADS2 risk stratification, who are prescribed warfarin OR another oral anticoagulant drug that is FDA approved for the prevention of thromboembolism. Rate of Carotid Artery Stenting (CAS) for Asymptomatic Patients, Without Major Complications (Discharged to Home by PostOperative Day #2): Percent of asymptomatic patients undergoing CAS who are discharged to home no later than VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Clinical Care Interrnedi ate Outcome Frm 00283 Fmt 4701 Effective Clinical Care Sfmt 4725 Rate of Asymptomatic Patients Undergoing Carotid Artery Stenting (CAS) Who Are Stroke Free or Discharged Alive: Percent of asymptomatic patients undergoing CAS who are stroke free while in the hospital or discharged alive Closing the Referral Loop: Receipt of Specialist Report: Percentage of patients with referrals, regardless of age, for which the referring provider receives a report from the provider to whom the patient was referred. Tobacco Use and Help with Quitting Among Adolescents: The percentage of adolescents 12 to 20 years of age with a primary care visit during the measurement year for whom tobacco use status was documented and received help with quitting if identified as a tobacco user. Preventive Care and Screening: Unhealthy Alcohol Use: Screening & Brief Counseling: Percentage of patients aged 18 years and older who were screened for unhealthy alcohol use using a systematic screening method at least once within the last 24 months AND who received brief counseling if identified as an unhealthy alcohol user. Statio Therapy for the Prevention and Treatment of Cardiovascular Disease: Percentage of the following patients-all considered at high risk of cardiovascular events-who were prescribed or were on stalin therapy during the measurement period: • Adults aged ~ 21 years who were previously diagnosed with or currently have an active diagnosis of clinical atherosclerotic cardiovascular disease (ASCVD); OR • Adults aged ~21 years who have ever had a fasting or direct low-density lipoprotein cholesterol (LDL-C) level~ 190 mg/dL; OR • Adults aged 40-75 years with a diagnosis of diabetes with a fasting or direct LDL-C level of 70-189 Ischemic Vascular Disease All or None Outcome Measure (Optimal Control): The IVD All-or-None Measure is one outcome measure (optimal control). The measure contains four All four within a measure must E:\FR\FM\23NOR3.SGM 23NOR3 Society for Vascular Surgeons Society for Vascular Surgeons Centers for Medicare& Medicaid Services Committee for Quality Assurance Physician Consortium Performance Improvement Foundation (PCPI) Medicare& Medicaid Services Wisconsin Collaborativ e for Health care ER23NO18.100</GPH> Specifications 60118 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.2. Cardiology be reached in order to meet that measure. The numerator for the all-or-none measure should be collected from the organization's total IVD denominator. All-or-None Outcome Measure (Optimal Control)Using the IVD denominator optimal results include: • Most recent blood pressure (BP) measurement is less than or equal to 140/90 mmHg--And • Most recent tobacco status is Tobacco Free-And • Daily Aspirin or Other Antiplatelet Unless Contraindicated -- And • Statin Use Unless Contraindicated 0071 442 A MIPSCQMs Specifications (WCHQ) Process Persistent Beta Blocker Treatment After a Heart Attack: Committee The percentage of patients 18 years of age and for Quality older during the measurement year who were Assurance hospitalized and discharged from July 1 of the year prior to the measurement year to June 30 of the measurement year with a diagnosis of acute myocardial infarction (AMI) and who received were prescribed persistent beta-blocker treatment for 6 months after Comment: One commenter supported the inclusion of measure Q243: Cardiac Rehabilitation Patient Referral from an Outpatient Setting measure in this measure set. The commenter noted that the inclusion of the performance measure, in the MIPS Cardiology Specialty Measure Sets is a first and important step in improving physician referral habits; however, the commenter stated that it will also be important to include the corresponding measure, Cardiac Rehabilitation Patient Referral from an Inpatient Setting as well. Clinical Care Response: We encourage the commenter to work with measures' developers to submit new measures through the Call for Measures process to include the measure related to the inpatient setting. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00284 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.101</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are finalizing the Cardiology Specialty Measure Set as proposed for the 2019 Performance Period and future years with the exception of Ischemic Vascular Disease Use of Aspirin or Anti-platelet Medication. We are no longer finalizing the inclusion of this measure as it is duplicative of a component 1: Ischemic Vascular Disease All or None Outcome Measure within Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 0068 N/A 204 373 CMS164v 7 CMS65v8 Medicare Part BClaims Measure Specifications, eCQM Specifications, CMSWeb Interface Measure Specifications, MIPS CQMs Specifications eCQM Specifications Process Intermediate Outcome Effective Clinical Care Effective Clinical Care Ischemic Vascular Disease (IVD): Use of Aspirin or Another Antiplatelet: Percentage of patients 18 years of age and older who were diagnosed with acute myocardial infarction (AMI), coronary artery bypass graft (CABG) or percutaneous coronary interventions (PCI) in the 12 months prior to the measurement period, or who had an active diagnosis of ischemic vascular disease (IVD) during the measurement period, and who had documentation of use of aspirin or another antiplatelet the measurement Hypertension: Improvement in Blood Pressure: Percentage of patients aged 1885 years of age with a diagnosis of hypertension whose blood pressure improved during the measurement period. National Committee for Quality Assurance Centers for Medicare & Medicaid Services 60119 program based on the detailed below for this measure in "Table C: Quality Measures Finalized for Removal in the 2021 MIPS Payment Year and Future Years." This measure is removed from the 2019 program based on the detailed rationale described below for this measure in "Table C: Quality Measures Finalized for Removal in the 2021 MIPS Payment Year and Future Years." We did not receive specific comments regarding the proposed removal of measures from this specialty measure set. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00285 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.102</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are finalizing the removal of measures from the Cardiology Specialty Measure Set as proposed for the 2019 Performance Period and future 60120 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.3. Gastroenterology In addition to the considerations discussed in the introductory language of Table Bin this final rule, the Gastroenterology specialty set takes into consideration the following criteria, which includes, but is not limited to: the measure reflects current clinical guidelines and the coding of the measure includes the specialists. We may reassess the appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. In addition, as outlined at the end of this table, we are not finalizing our proposal to remove Quality ID: 185 (MIPS CQMs Specifications) from the specialty set, but we are finalizing our proposal to remove Quality ID: 185 (Medicare Part B Claims Measure Specifications). Therefore, Q185 is now included in this measure set table for the final rule with MIPS CQMs Specifications as the collection type. B.3. Gastroenterology (Care Coordination) * § 0326 0421 047 Process Communication and Care Coordination CMS69v7 Medicare Part B Claims Measure Specifications, eCQM Specifications, MIPSCQMs Specifications 128 Process Community/ Population Health Process Patient Safety Process Communication and Care Coordination 0419 130 CMS68v8 Medicare Part B Claims Measure Specifications, eCQM Specifications, MIPSCQMs Specifications 0659 185 N/A MIPSCQMs Specifications 0028 226 CMS138v7 ! (Patient Safety) § amozie on DSK3GDR082PROD with RULES3 § VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 Medicare Part B Claims PO 00000 Frm 00286 Process Fmt 4701 Community/Po pulation Health Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 National Committee for Quality Assurance Centers for Medicare& Medicaid Services Centers for Medicare& Medicaid Services American Gastroentero logical Association Physician Consortium for ER23NO18.103</GPH> N/A Medicare Part B Claims Measure Specifications, MIPSCQMs Specifications ! Advance Care Plan: Percentage of patients aged 65 years and older who have an advance care plan or surrogate decision maker documented in the medical record or documentation in the medical record that an advance care plan was discussed but the patient did not wish or was not able to name a surrogate decision maker or provide an advance care Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up Plan: Percentage of patients aged 18 years and older with a BMI documented during the current encounter or during the previous 12 months AND with a BMI outside of normal parameters, a follow-up plan is documented during the encounter or during the previous 12 months of the current encounter. Normal Parameters: Age 18 years and older BMI => 18.5 and <25 Documentation of Current Medications in the Medical Record: Percentage of visits for patients aged 18 years and older for which the eligible professional or eligible clinician attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list must include ALL known prescriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutritional) supplements AND must contain the medications' name, dosage, and route of administration. Colonoscopy Interval for Patients with a History of Adenomatous PolypsAvoidance oflnappropriate Use: Percentage of patients aged 18 years and older receiving a surveillance colonoscopy, with a history of a prior adenomatous polyp(s) in previous colonoscopy fmdings, who had an interval of 3 or more years since their last Preventive Care and Screening: Tobacco Use: Screening and Cessation Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60121 B.3. Gastroenterology § N/A N/A 275 § § 271 N/A 317 0658 320 CMS22v7 ! (Care Coordination) § N/A 343 N/A MIPSCQMs Specifications Process Effective Clinical Care MIPSCQMs Specifications Process Medicare Part BClaims Measure Specifications, eCQM Specifications, MIPSCQMs Specifications Process Part BClaims Measure Specifications, MIPSCQMs Specifications Process MIPSCQMs Specifications Outcome Clinical Care Community /Population Health and Care Coordination Effective Clinical Care a. Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months. b. Percentage of patients aged 18 years and older who were screened for tobacco use and identified as a tobacco user who received tobacco cessation intervention. c. Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user. Inflammatory Bowel Disease (IBD): Preventive Care: Corticosteroid Related Iatrogenic Injury- Bone Loss Assessment: Percentage of patients with an inflammatory bowel disease encounter who were prescribed prednisone equivalents greater than or equal to 10 mg/day for 60 or greater consecutive days or a single prescription equating to 600 mg prednisone or greater for all fills and were documented for risk of bone loss once during the reporting year or the previous calendar year. Individuals who received an assessment for bone loss during the prior or current are considered screened. Inflammatory Bowel Disease (IBD): Assessment of Hepatitis B Virus (HBV) Status Before Initiating AntiTNF (Tumor Necrosis Factor) Therapy: Percentage of patients with a diagnosis of inflammatory bowel disease (IBD) who had Hepatitis B Virus (HBV) status assessed and results interpreted prior to initiating anti-TNF (tumor necrosis Preventive Care and Screening: Screening for High Blood Pressure and Follow-Up Documented: Percentage of patients aged 18 years and older seen during the reporting period who were screened for high blood pressure AND a recommended follow-up plan is documented based on the current blood as indicated. Appropriate Follow-Up Interval for Normal Colonoscopy in Average Risk Patients: Percentage of patients aged 50 to 75 years of age receiving a screening colonoscopy without biopsy or polypectomy who had a recommended follow-up interval of at least 10 years for colonoscopy documented in their Screening Colonoscopy Adenoma Detection Rate Measure: The amozie on DSK3GDR082PROD with RULES3 or VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00287 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 Performance Improvement Foundation (PCPI®) American Gastroenterologial Association Gastroenterological Association Centers for Medicare& Medicaid Services Gastroentero logical Association American Society for Gastrointesti ER23NO18.104</GPH> Specifications, eCQM Specifications, CMSWeb Interface Measure Specifications, MIPSCQMs Specifications 60122 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.3. Gastroenterology 374 CMS50v7 eCQM Specifications, MIPSCQMs Specifications Process Communication and Care Coordination ! (Patient Experience) N/A 390 N/A MIPSCQMs Specifications Process Person and CaregiverCentered Experience and Outcomes Specifications N/A amozie on DSK3GDR082PROD with RULES3 2152 VerDate Sep<11>2014 402 431 19:26 Nov 21, 2018 N/A N/A Jkt 247001 Clinical Care MIPSCQMs Specifications Process Part BClaims Measure Specifications, MIPSCQMs Specifications Process MIPSCQMs Specifications Process PO 00000 Frm 00288 Community/ Population Health Clinical Care Fmt 4701 Community/ Population Health Sfmt 4725 Centers for Medicare& Medicaid Services Hepatitis C: Discussion and Shared Decision Making Surrounding Treatment Options: Percentage of patients aged 18 years and older with a diagnosis of hepatitis C with whom a physician or other qualified healthcare professional reviewed the range of treatment options appropriate to their genotype and demonstrated a shared decision making approach with the patient. To meet the measure, there must be documentation in the patient record of a discussion between the physician or other qualified healthcare professional and the patient that includes all of the following: treatment choices appropriate to genotype, risks and benefits, evidence of effectiveness, and patient preferences toward treatment. Hepatitis C: Screening for Hepatocellular Carcinoma (HCC) in Patients with Cirrhosis: Percentage of patients aged 18 years and older with a diagnosis of chronic hepatitis C cirrhosis who underwent imaging with either ultrasound, contrast enhanced CT or MRI for hepatocellular carcinoma (HCC) at least once within the 12-month American Gastroentero logical Association Tobacco Use and Help with Quitting Among Adolescents: The percentage of adolescents 12 to 20 years of age with a primary care visit during the measurement year for whom tobacco use status was documented and received help with quitting if identified as a tobacco user. Photodocumentation of Cecal Intubation: The rate of screening and surveillance colonoscopies for which photodocumentation of at least two landmarks of cecal intubation is performed to establish a complete examination. Preventive Care and Screening: Unhealthy Alcohol Use: Screening & Brief Counseling: Percentage of patients aged 18 years and older who were screened for unhealthy National Committee for Quality Assurance E:\FR\FM\23NOR3.SGM 23NOR3 Gastroentero logical Association Society for Gastrointesti nal Endoscopy Physician Consortium for Performance Improvement ER23NO18.105</GPH> N/A ! (Care Coordination) Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60123 B.3. Gastroenterology method at least once within the last 24 (PCPI®) months AND who received brief counseling if identified as an unhealthy alcohol user. § N/A MIPSCQMs Efficienc Efficiency and N/A 439 American Age Appropriate Screening Colonoscopy: The percentage of patients Specifications y Cost Reduction Gastroentero ! greater than 85 years of age who (Efficiency) logical received a screening colonoscopy from Association 1 to 31. Comment: A few commenters did not support removal of measure Q 185: Colonoscopy Interval for Patients with a History of Adenomatous Polyps - Avoidance of Inappropriate Use. One commenter noted that updated guidelines on the appropriate follow-up interval for patients with a history of adenomatous polyps are set to be released in the near future. This commenter noted that it is likely that the measure specifications will be updated at that point, which may alter clinician performance. This commenter recommended that CMS retain the measure in MIPS until it is able to review other stakeholder concerns about measure performance, and that CMS work with the measure developer to update the MIPS measure specifications when new guidelines are released. Response: We agree that updated guidelines could affect the performance of this measure causing the measure to have a substantive change, and therefore, may no longer have a benchmark that is considered to be topped out. We note this measure shows a 97.7 percent average performance for Medicare Part B Claims Measure Specifications while the MIPS CQMs Specification (registry) version shows less than 97 percent average performance rate. Based on our extremely topped out measure removal policy, we are only finalizing the removal of this measure from the Medicare Part B Claims Measure Specification collection type for the 2019 performance period. We will not finalize the removal of MIPS CQM s Specification collection type. We will work with the measure steward to update for the new clinical guidelines once they are released and continue to monitor the performance of the MIPS CQM Measure Specification in the future. Comment: One commenter expressed concern about the scoring methodology of measure Q343: Screening Colonoscopy Adenoma Detection Rate as a performance rate near 100 percent would not indicate better care. The commenter stated that in a typical population about 25 percent of colonoscopies should find an adenoma to set a benchmark of 25 percent for all populations. From a clinical and performance measure perspective, while it may be true that a 0 percent or 5 percent rate would be worrisome, the commenter stated there is no reason to believe that a rate of20 percent is worse than 30 percent or that 40 percent is better than 35 percent or 45 percent. A rate of 90 percent would be suspicious. Response: We will explore options to alter the scoring methodology to assign higher deciles to the 25th to 35th percentiles or consider removing the measure in future rulemaking. We encourage measure stewards to explore options that address appropriate adenoma detection and submit measures for consideration to the annual Call for Measures. Comment: One commenter indicated that the measure steward listed in the proposed rule for measure Q343: Screening Colonoscopy Adenoma Detection Rate is incorrect and asked that the measure steward be corrected. Response: We agree with the commenter that the measure steward was incorrectly listed as the American Gastroenterological Association. This has been updated to the American Society for Gastrointestinal Endoscopy. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00289 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.106</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are finalizing the Gastroenterology Specialty Measure Set as proposed for the 2019 Performance Period and future years. As noted above, we are not fmalizing the removal of measure Ql85 (MIPS CQM specification) from the Gastroenterology Specialty Measure Set for the 2019 Performance Period and has been this 60124 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.4. Dermatology In addition to the considerations discussed in the introductory language of Table Bin this fmal rule, the Dermatology specialty set takes into consideration the following criteria, which includes, but is not limited to: the measure reflects current clinical guidelines and the coding of the measure includes the specialists. We may reassess the appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. In addition, as outlined at the end of this table, we removed the following quality measure from the specialty set: Quality ID: 224. B.4. Dermatology 0419 130 CMS68v8 ! (Care Coordination) N!A 137 N!A MIPSCQMs Specifications Structure Communication and Care Coordination ! (Care Coordination) N!A 138 N!A MIPSCQMs Specifications Process Communication and Care Coordination 0028 226 CMS138v7 § N!A 265 N!A amozie on DSK3GDR082PROD with RULES3 ! (Care Coordination) VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 Process Patient Safety Medicare Part B Claims Measure Specifications, eCQM Specifications, CMS Web Interface Measure Specifications, MIPSCQMs Specifications Process MIPSCQMs Specifications Process PO 00000 Frm 00290 Community/ Population Health Fmt 4701 Communication and Care Coordination Sfmt 4725 Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: a. Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months. b. Percentage of patients aged 18 years and older who were screened for tobacco use and identified as a tobacco user who received tobacco cessation intervention. c. Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user. Biopsy Follow-Up: Percentage of new patients whose biopsy results have been reviewed and communicated to the primary care/referring physician and E:\FR\FM\23NOR3.SGM 23NOR3 Centers for Medicare & Medicaid Services American Academy of Dermatology American Academy of Dermatology Physician Consortium for Performance Improvement Foundation (PCP!®) American Academy of Dermatology ER23NO18.107</GPH> ! (Patient Safety) Medicare Part B Claims Measure Specifications, eCQM Specifications, MIPSCQMs Specifications Documentation of Current Medications in the Medical Record: Percentage of visits for patients aged 18 years and older for which the eligible professional or eligible clinician attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list must include ALL known prescriptions, overthe-counters, herbals, and vitamin/mineral/dietary (nutritional) supplements AND must contain the medications' name, dosage, frequency and route of administration. Melanoma: Continuity of Care- Recall System: Percentage of patients, regardless of age, with a current diagnosis of melanoma or a history of melanoma whose information was entered, at least once within a 12-month period, into a recall system that includes: • A target date for the next complete physical skin exam, AND • A process to follow up with patients who either did not make an appointment within the specified timeframe or who missed a scheduled Melanoma: Coordination of Care: Percentage of patients visits, regardless of age, with a new occurrence of melanoma, who have a treatment plan documented in the chart that was communicated to the physician( s) providing continuing care within 1 month of Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60125 B.4. Dermatology 317 CMS22v7 Medicare Part BClaims Measure Specifications, eCQM Specifications, MlPSCQMs Specifications Process Community /Population Health Process Clinical Care Specifications ! (Care Coordination) N/A 440 N/A amozie on DSK3GDR082PROD with RULES3 (Care Coordination) VerDate Sep<11>2014 Process MIPS Specifications Process Caregiver Centered Experience and Outcomes 19:26 Nov 21, 2018 Jkt 247001 MlPSCQMs Specifications PO 00000 Frm 00291 Process Fmt 4701 Communication and Care Coordination Sfmt 4725 Centers for Medicare & Medicaid Services Academy of Dermatology Centers Medicare & Medicaid Services and Care Coordination Specifications ! (Outcome) ! eCQM Specifications, MlPSCQMs Specifications Preventive Care and Screening: Screening for High Blood Pressure and Follow-Up Documented: Percentage of patients aged 18 years and older seen during the reporting period who were screened for high blood pressure AND a recommended follow-up plan is documented based on the current blood pressure (BP) as indicated. Psoriasis: Tuberculosis (TB) Prevention for Patients with Psoriasis, Psoriatic Arthritis and Rheumatoid Arthritis on a Biological Immune Response Modifier: Percentage of patients, regardless of age, with Psoriasis, Psoriatic Arthritis and Rheumatoid Arthritis on a Biological Immune Response Modifier whose providers are ensuring active tuberculosis prevention either through yearly negative standard tuberculosis screening tests or are reviewing the patient's history to determine if they have had appropriate management for a recent or test. Medications: Percentage of psoriasis vulgaris patients receiving systemic therapy who meet minimal physician-or patient- reported disease activity levels. It is implied that establishment and maintenance of an established minimum level of disease control as measured by physicianand/or patient-reported outcomes will increase patient satisfaction with and adherence to treatment Basal Cell Carcinoma (BCC)/Squamons Cell Carcinoma: Biopsy Reporting TimePathologist to Clinician: Basal Cell Carcinoma (BCC)/Squamous Cell Carcinoma (SCC): Biopsy Reporting TimePathologist to Clinician: Percentage of biopsies with a diagnosis of cutaneous Basal Cell Carcinoma (BCC) and Squamous Cell Carcinoma (SCC) (including in situ disease) in which the pathologist communicates results to the clinician within 7 days from the time when the tissue specimen was received by the E:\FR\FM\23NOR3.SGM 23NOR3 Academy of Dermatology American Academy of Dermatology ER23NO18.108</GPH> N/A 60126 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations Comment: One commenter was pleased this measure set includes measures Q337: Psoriasis: Tuberculosis (TB) Prevention for Patients with Psoriasis, Psoriatic Arthritis and Rheumatoid Arthritis on a Biological Immune Response Modifier and Q410: Psoriasis Clinical Response to Systemic Medication. Inclusion of these measures will advance psoriatic disease care and help to ensure that clinicians are accountable for meaningful measures that have the greatest impact on patient care. A second commenter appreciated that CMS accepted its recommendations to update the description and expand the measure numerator and denominator. Response: We thank the commenter for their support of these measures. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00292 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.109</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are finalizing the Dermatolof!Y Specialty Measure Set as proposed for the 2019 Performance Period and future years. Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60127 B.4 Dermatology (continued) N/A 224 N/A MIPS CQMs Specificatio ns Process Efficiency and Cost Reduction We Melanoma: Avoidance of Overutilization oflmaging Studies: Percentage of patients, regardless of age, with a current diagnosis of stage 0 through IIC melanoma or a history of melanoma of any stage, without signs or symptoms suggesting systemic spread, seen for an office visit during the one-year measurement period, for whom no diagnostic imaging studies were ordered. measure set. American Academy of Dermatology program based on the detailed rationale described below for this measure in "Table C: Quality Measures Finalized for Removal in the 2021 MIPS Payment Year and Future Years." VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00293 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.110</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are finalizing the removal of measures from the Dermatology Measure Set as proposed for the 2019 Performance Period and future 60128 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.S. Family Medicine In addition to the considerations discussed in the introductory language of Table B in this fmal rule, the Family Medicine specialty set takes into consideration the following criteria, which includes, but is not limited to: the measure reflects current clinical guidelines and the coding of the measure includes the specialists. We may reassess the appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. In addition, as outlined at the end of this table, we removed the following quality measures from the specialty set: Quality IDs: 163, 204, 334, 373, and 447. B.S. Family Medicine 001 § 0081 005 CMS135 v7 eCQM Specifications, MIPSCQMs Specifications § 0067 006 NIA MIPSCQMs Specifications § amozie on DSK3GDR082PROD with RULES3 0059 CMS122 v7 VerDate Sep<11>2014 CMS145 v7 eCQM Specifications, MIPSCQMs Specifications Intermediate Outcome Effective Clinical Care Process Effective Clinical Care Process Effective Clinical Care 007 0083 008 CMS144 v7 eCQM Specifications, MIPSCQMs Specifications Process Effective Clinical Care 0105 009 CMS128 v7 eCQM Specifications Process Effective Clinical Care 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Process Effective Clinical Care 0070 Frm 00294 Fmt 4701 Sfmt 4725 Diabetes: Hemoglobin Ale (HbAlc) Poor Control (>9%): Percentage of patients 18-75 years of age with diabetes who had hemoglobin Ale> 9.0 percent during the measurement period. Heart Failure (HF): Angiotensin-Converting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) Therapy for Left Ventricular Systolic Dysfunction (LVSD): Percentage of patients aged 18 years and older with a diagnosis of heart failure (HF) with a current or prior left ventricular ejection fraction (L VEF) < 40 percent who were prescribed ACE inhibitor or ARB therapy either within a 12month period when seen in the outpatient OR at each Chronic Stable Coronary Artery Disease: Antiplatelet Therapy: Percentage of patients aged 18 years and older with a diagnosis of coronary artery disease (CAD) seen within a 12-month period who were Coronary Artery Disease (CAD): BetaBlocker Therapy-Prior Myocardial Infarction (MI) or Left Ventricular Systolic Dysfunction (LVEF <40%): Percentage of patients aged 18 years and older with a diagnosis of coronary artery disease seen within a 12-month period who also have prior MI OR a current or prior LVEF < 40 percent beta-blocker who were Heart Failure (HF): Beta-Blocker Therapy for Left Ventricular Systolic Dysfunction (LVSD): Percentage of patients aged 18 years and older with a diagnosis of heart failure (HF) with a current or prior left ventricular ejection fraction (L VEF) < 40 percent who were prescribed betablocker therapy either within a 12-month period when seen in the outpatient setting OR at each Anti-Depressant Medication Management: Percentage of patients 18 years of age and older who were treated with antidepressant medication, had a diagnosis of major depression, and who remained on antidepressant medication treatment. E:\FR\FM\23NOR3.SGM 23NOR3 National Committee for Quality Assurance Physician Consortium for Performance Improvement Foundation (PCP!®) American Association Physician Consortium for Performance Improvement Foundation (PCP!®) Physician Consortium for Performance Improvement Foundation (PCPI®) National Committee for Quality Assurance ER23NO18.111</GPH> § ! (Outcome) Medicare Part BClaims Measure Specifications, CMS Web Interface Measure Specifications, MIPSCQMs Specifications, eCQM Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60129 B.S. Family Medicine ! (Care Coordination) N!A 0046 024 N/A Medicare Part BClaims Measure Specifications, MIPSCQMs Specifications Process Communication and Care Coordination Communication with the Physician or Other Clinician Managing On-going Care PostFracture for Men and Women Aged 50 Years and Older: Percentage of patients aged 50 years and older treated for a fracture with documentation of communication, between the physician treating the fracture and the physician or other clinician managing the patient's on-going care, that a fracture occurred and that the patient was or should be considered for osteoporosis treatment or testing. This measure is reported by the physician who treats the fracture and who therefore is held accountable for the National Committee for Quality Assurance 039 N/A Medicare Part BCiaims Measure Specifications, MIPSCQMs Process Effective Clinical Care Screening for Osteoporosis for Women Aged 65-85 Years of Age: Percentage of female patients aged 65-85 years of age who ever had a central dual-energy X-ray absorptiometry (DXA) to check for National Committee for Quality Assurance Advance Care Plan: Percentage of patients aged 65 years and older who have an advance care plan or surrogate decision maker documented in the medical and Care Coordination ! (Patient Experience) N/A ! (Appropriate Use) 0069 050 N/A Person and CaregiverCentered Experience and Outcomes Specifications, MIPSCQMs Specifications 065 CMS154v eCQM 7 Specifications, MIPSCQMs Specifications Process Efficiency and Cost Reduction Urinary Incontinence: Plan of Care for Urinary Incontinence in Women Aged 65 Years and Older: Percentage of female patients aged 65 years and older with a diagnosis of urinary incontinence with a documented plan of care for urinary incontinence at least once within 12 months. Appropriate Treatment for Children with Upper Respiratory Infection (URI): Percentage of children 3 months through 18 years of age who were diagnosed with upper infection (URI) and were not dispensed an antibiotic prescription on or 3 days after the National Committee for Quality Assurance National Committee for Quality Assurance Process VerDate Sep<11>2014 7 19:26 Nov 21, 2018 Jkt 247001 Specifications, MIPSCQMs PO 00000 Frm 00295 Committee for Quality Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.112</GPH> amozie on DSK3GDR082PROD with RULES3 (Appropriate Use) 60130 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.S. Family Medicine ! (Appropriate Use) ! (Appropriate Use) 107 CMS161 v7 ! amozie on DSK3GDR082PROD with RULES3 (Patient Experience) VerDate Sep<11>2014 eCQM Specifications Process Effective Clinical Care Part BClaims Measure Specifications. MIPSCQMs Process Person Caregiver Centered Experience and Outcomes Osteoarthritis (OA): Function and Pain Assessment: Percentage of patient visits for patients aged 21 years and older with a diagnosis of osteoarthritis (OA) with assessment for function and pain. Physician Consortium for Performance Improvement Foundation (PCPI®) Academy of Orthopedic Surgeons 0041 110 CMS147 v8 Medicare Part BClaims Measure Specifications, eCQM Specifications, CMS Web Interface Measure Specifications, MIPSCQMs Process Community/ Population Health Preventive Care and Screening: Influenza Immunization: Percentage of patients aged 6 months and older seen for a visit between October 1 and March 31 who received an influenza immunization OR who reported previous receipt of an influenza immunization. Physician Consortium for Performance Improvement Foundation (PCPI®) N/A 111 CMS127 v7 Medicare Part BClaims Measure Specifications, eCQM Specifications, MIPSCQMs Process Community/ Population Health Pneumococcal Vaccination Status for Older Adults: Percentage of patients 65 years of age and older who have ever received a pneumococcal vaccine. National Committee for Quality Assurance 2372 112 CMS125 v7 Medicare Part BClaims Measure Specifications, eCQM Specifications, CMSWeb Interface Measure Specifications, MIPSCQMs Process Effective Clinical Care Breast Cancer Screening: Percentage of women 51 -74 years of age who had a mammogram to screen for breast cancer. National Committee for Quality Assurance v7 BClaims Measure 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Clinical Care Frm 00296 Fmt 4701 Sfmt 4725 for E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.113</GPH> 0104 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60131 B.S. Family Medicine Specifications, eCQM Specifications, CMS Web Interface Measure Specifications, MIPSCQMs § ! (Appropriate Use) Assurance 0058 116 N/A Process Efficiency and Cost Reduction Avoidance of Antibiotic Treatment in Adnlts with Acnte Bronchitis: The percentage of adults 18-64 years of age with a diagnosis of acute bronchitis who were not prescribed or dispensed an antibiotic National Committee for Quality Assurance 0055 117 CMS131 v7 Process Effective Clinical Care Diabetes: Eye Exam: Percentage of patients 18 - 75 years of age with diabetes who had a retinal or dilated eye exam by an eye care professional during the measurement period or a negative retinal exam (no evidence of retinopathy) in the 12 months to the measurement Diabetes: Medical Attention for Nephropathy: The percentage of patients 18-75 years of age with diabetes who had a nephropathy screening test or evidence of the measurement Diabetes Mellitus: Diabetic Foot and Ankle Care, Peripheral Neuropathy -Neurological Evaluation: Percentage of patients aged 18 years and older with a diagnosis of diabetes mellitus who had a examination of National Committee for Quality Assurance Specifications, eCQM Specifications, MIPSCQMs * 0062 119 CMS134 v7 eCQM Specifications, MIPSCQMs Specifications Process Effective Clinical Care 0417 126 N/A MIPSCQMs Specifications Process Effective Clinical Care 0421 128 CMS69v 7 Medicare Part BClaims Measure Specifications, eCQM Specifications, MIPSCQMs Specifications Process Community/Pop ulation Health ! (Patient Process Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up Plan: Percentage of patients aged 18 years and older with a BMI documented during the current encounter or during the previous 12 months AND with a BMI outside of normal parameters, a follow-up plan is documented during the encounter or during the previous 12 months of the current encounter. Normal Parameters: Age 18 years and older BMI => 18.5 and< 25 National Committee for Quality Assurance American Podiatric Medical Association Centers for Medicare& Medicaid Services Documentation of Cnrrent Medications in the Medical Record: Percentage of visits for patients aged 18 years older for which the eligible professional or eligible clinician attests to documenting a list of current medications using all immediate available on the date of the encounter. This list must include ALL known prescriptions, over-thecounters, herbals, and vitamin/mineral/dietary (nutritional) supplements AND must contain the medications' name, dosage, frequency and route Specifications, eCQM Specifications, MIPSCQMs Specifications Process VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00297 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.114</GPH> amozie on DSK3GDR082PROD with RULES3 Population Health 60132 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.S. Family Medicine encounter using an age appropriate standardized depression screening tool AND if positive, a follow-up plan is documented on the date of the positive screen. ! (Patient Safety) 0101 154 Process Patient Safety Falls: Risk Assessment: Percentage of patients aged 65 years and older with a history of falls who had a risk assessment for falls completed within 12 months. National Committee for Quality Assurance ! (Care Coordination) 0101 155 Process Communication and Care Coordination Falls: Plan of Care: Percentage of patients aged 65 years and older with a history of falls who had a plan of care for falls documented within 12 months. National Committee for Quality Assurance NA 181 Process Patient Safety Elder Maltreatment Screen and Follow-Up Plan: Percentage of patients aged 65 years and older with a documented elder maltreatment screen using an Elder Maltreatment Screening Tool on the date of encounter AND a documented follow-up plan on the date of the positive Centers for Medicare& Medicaid Services 0028 226 Process Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: a. Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months. b. Percentage of patients aged 18 years and older who were screened for tobacco use and identified as a tobacco user who received tobacco cessation intervention. c. Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user. Controlling High Blood Pressure: Percentage of patients 18-85 years of age who had a diagnosis of hypertension and whose blood pressure was adequately controlled (<140/90mrnHg) during the measurement period. Physician Consortium for Performance Improvement Foundation (PCPI®) ! (Patient Safety) lation Health Specifications, eCQM Specifications, CMS Web Interface Measure Specifications, MIPSCQMs Specifications 0018 236 ! (Outcome) amozie on DSK3GDR082PROD with RULES3 ! (Patient Safety) VerDate Sep<11>2014 CMS165 v7 0022 238 CMS156 v7 0643 243 N/A 19:26 Nov 21, 2018 Jkt 247001 Medicare Part BClaims Measure Specifications, eCQM Specifications, CMS Web Interface Measure Specifications, MIPSCQMs eCQM Specifications, MIPSCQMs Specifications Intermediate Outcome Process Effective Clinical Care Patient Safety Process PO 00000 Frm 00298 Fmt 4701 Sfmt 4725 Use of High-Risk Medications in the Elderly: Percentage of patients 65 years of age and older who were ordered high-risk medications. Two rates are reported. a. Percentage of patients who were ordered at least one high-risk medication. b. Percentage of patients who were ordered at medications. least two of the same Patient Referral from E:\FR\FM\23NOR3.SGM 23NOR3 National Committee for Quality Assurance National Committee for Quality Assurance ER23NO18.115</GPH> Specifications, CMSWeb Interface Measure Specifications, MIPSCQMs Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60133 B.S. Family Medicine ! (Opioid) Coordination 0004 0032 amozie on DSK3GDR082PROD with RULES3 § ! (Patient Experience) VerDate Sep<11>2014 305 309 CMS137 v7 eCQM Specifications Process CMS124 v7 eCQM Specifications Process 7 BCiaims Measure Specifications, eCQM Specifications, MIPSCQMs Specifications Percentage of patients evaluated in an outpatient setting who within the previous 12 months have experienced an acute myocardial infarction (MI), coronary artery bypass graft (CABG) surgery, a percutaneous coronary intervention (PC!), cardiac valve surgery, or cardiac transplantation, or who have chronic stable angina (CSA) and have not already participated in an early outpatient cardiac rehabilitation/secondary prevention (CR) program for the qualifYing event/diagnosis who Initiation and Engagement of Alcohol and Other Drug Dependence Treatment: Percentage of patients 13 years of age and older with a new episode of alcohol and other drug (AOD) dependence who received the following. Two rates are reported. • Percentage of patients who initiated treatment within 14 days of the diagnosis. • Percentage of patients who initiated treatment and who had two or more additional services with an AOD diagnosis Clinical Care Association Committee for Quality Assurance Cervical Cancer Screening: Percentage of women 21-64 years of age who were screened for cervical cancer using either of the following criteria: • Women age 21-64 who had cervical cytology perlormed every 3 years • Women age 30--64 who had cervical cytology/human papillomavirus (HPV) co- National Committee for Quality Assurance /Population Health for High Blood Pressure and Follow-Up Documented: Percentage of patients aged 18 years and older seen during the reporting period who were screened for high blood pressure AND a recommended follow-up plan is documented based on the current blood pressure (BP) reading as indicated. Medicare & Medicaid Services Clinical Care 0101 318 CMS139 v7 eCQM Specifications, CMS Web Interlace Measure Process Patient Safety Falls: Screening for Future Fall Risk: Percentage of patients 65 years of age and older who were screened for future fall risk during the measurement period. National Committee for Quality Assurance 0005 & 0006 321 N/A CMSapproved Survey Vendor Patient Engagement/ Experience Person and CaregiverCentered Experience and Outcomes CAHPS for MIPS Clinician/Group Survey: The Consumer Assessment ofHealthcare Providers and Systems (CAHPS) for MIPS Clinician/Group Survey is comprised of 10 Summary Survey Measures (SSMs) and measures patient experience of care within a group practice. The NQF endorsement status and endorsement id (if applicable) for each SSM utilized in this measure are as follows: • Getting Timely Care, Appointments, and Information; (Not endorsed by NQF) • How well Providers Communicate; (Not Agency for Healthcare Research & Quality (AHRQ) 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00299 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 Centers for Medicare& Medicaid Services ER23NO18.116</GPH> Coordination) 60134 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.S. Family Medicine 326 N/A Medicare Part BClaims Measure Specifications, MIPSCQMs Specifications Process Effective Clinical Care ! (Appropriate Use) N/A 331 N/A MIPSCQMs Specifications Process Efficiency and Cost Reduction ! (Appropriate Use) N/A 332 N/A MIPSCQMs Specifications Process Efficiency and Cost Reduction (Appropriate Use) amozie on DSK3GDR082PROD with RULES3 2082 VerDate Sep<11>2014 338 19:26 Nov 21, 2018 N/A Jkt 247001 Specifications Cost Reduction Specifications Clinical Care MIPSCQMs Specifications PO 00000 Outcome Frm 00300 Fmt 4701 Effective Clinical Care Sfmt 4725 American Association American Academy of Otolaryngology -Head and Surgery Adult Sinusitis: Appropriate Choice of Antibiotic: Amoxicillin With or Without Clavulanate Prescribed for Patients with Acute Bacterial Sinusitis (Appropriate Use): Percentage of patients aged 18 years and older with a diagnosis of acute bacterial sinusitis that were prescribed amoxicillin, with or without clavulanate, as a first line antibiotic at the time Tomography (CT) for Acute Sinusitis (Overuse): Percentage of patients aged 18 years and older with a diagnosis of acute sinusitis who had a computerized tomography (CT) scan of the paranasal sinuses ordered at the time of diagnosis or received within 28 days after date Psoriasis: Tuberculosis (TB) Prevention for Patients with Psoriasis, Psoriatic Arthritis and Rheumatoid Arthritis on a Biological Immune Response Modifier: Percentage of patients, regardless of age, with Psoriasis, Psoriatic Arthritis and Rheumatoid Arthritis on a Biological Immune Response Modifier whose providers are ensuring active tuberculosis prevention either through yearly negative standard tuberculosis screening tests or are reviewing the patient's history to determine if they have had appropriate management for a recent or test HIV Viral Load Suppression: The percentage of patients, regardless of age, E:\FR\FM\23NOR3.SGM 23NOR3 Academy of Otolaryngology -Head and Surgery Academy of Dermatology Health Resources and ER23NO18.117</GPH> 1525 • Patient's Rating of Provider; (NQF endorsed# 0005) • Access to Specialists; (Not endorsed by NQF) • Health Promotion and Education; (Not endorsed by NQF) • Shared Decision-Making; (Not endorsed by NQF) • Health Status and Functional Status; (Not endorsed by NQF) • Courteous and Helpful Office Staff; (NQF endorsed # 0005) • Care Coordination; (Not endorsed by NQF) • Stewardship of Patient Resources. (Not endorsed Atrial Fibrillation and Atrial Flutter: Chronic Anticoagulation Therapy: Percentage of patients aged 18 years and older with nonvalvular atrial fibrillation (AF) or atrial flutter who were prescribed warfarin OR another FDA- approved anticoagulant drug for the prevention of thromboembolism during the measurement Adult Sinusitis: Antibiotic Prescribed for Acute Sinusitis (Overuse): Percentage of patients, aged 18 years and older, with a diagnosis of acute sinusitis who were prescribed an antibiotic within 10 days after Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60135 B.S. Family Medicine CaregiverCentered Experience and Outcomes Specifications 0710 370 CMS159 v7 eCQM Specifications, CMS Web Interface Measure Specifications, MIPSCQMs Outcome Effective Clinical Care Depression Remission at Twelve Months: The percentage of adolescent patients 12 to 17 years of age and adult patients 18 years of age or older with major depression or dysthymia who reached remission 12 months (+/- 60 days) after an index event date. Minnesota Community Measurement 0712 371 CMS160 v7 eCQM Specifications Process Effective Clinical Care Depression Utilization of the PHQ-9 Tool: The percentage of adolescent patients (12 to 17 years of age) and adult patients (18 years of age or older) with a diagnosis of major depression or dysthymia who have a completed PHQ·9 or MN Community Measurement 7 Specifications, MIPSCQMs Specifications ! (Outcome) Process (Care Coordination) and Care Coordination Closing the Referral Loop: Receipt of Specialist Report: Percentage of patients with referrals, regardless of age, for which the referring provider receives a report from the provider to whom the patient was referred. Functional Status Assessments for Congestive Heart Failure: Percentage of patients 18 years of age and older with congestive heart failure who completed initial and follow-up patient-reported functional Medicare & Medicaid Services ! (Patient Experience) N/A 377 CMS90v 8 eCQM Specifications Process Person and CaregiverCentered Experience and Outcomes ! (Outcome) 1879 383 N/A MIPSCQMs Specifications Intermediate Outcome Patient Safety Adherence to Antipsychotic Medications for Individuals with Schizophrenia: Percentage of individuals at least 18 years of age as of the beginning of the measurement period with schizophrenia or schizoaffective disorder who had at least two prescriptions filled for any antipsychotic medication and who had a Proportion of Days Covered (PDC) of at least 0.8 for antipsychotic medications during the measurement period (12 consecutive Health Services Advisory Group N/A 387 N/A MIPSCQMs Specifications Process Effective Clinical Care Annual Hepatitis C Virus (HCV) Screening for Patients who are Active Injection Drug Users: Percentage of patients regardless of age who are active injection drug users who received screening for HCV infection within the 12month Physician Consortium for Performance Improvement Foundation (PCPI®) Population Health The percentage of adolescents 13 years of age who had the recommended immunizations by Committee for Quality Optimal Asthma Control: Composite measure of the percentage of pediatric and adult patients whose asthma is well-controlled as demonstrated one of three Minnesota Community Measurement MIPSCQMs Specifications ! (Outcome) amozie on DSK3GDR082PROD with RULES3 Hospice and Palliative Care Organization VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Outcome Frm 00301 Clinical Care Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 Centers for Medicare & Medicaid Services ER23NO18.118</GPH> (Outcome) 60136 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.S. Family Medicine NIA ! (Opioid) Clinical Care 402 N/A amozie on DSK3GDR082PROD with RULES3 VerDate Sep<11>2014 Process MIPSCQMs Specifications Process Community/ Population Health 408 N!A MIPSCQMs Specifications Process Effective Clinical Care NIA 412 NIA MIPSCQMs Specifications Process Effective Clinical Care N/A 414 N/A MIPSCQMs Specifications Process Effective Clinical Care 0053 418 NIA Medicare Part BClaims Measure Specifications, MIPSCQMs Specifications Process Effective Clinical Care 2152 431 NIA MIPSCQMs Specifications Process Community/ Population Health 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00302 Fmt 4701 Performance Improvement Foundation (PCPI®) Hepatitis C: Screening for Hepatocellular Carcinoma (HCC) in Patients with Cirrhosis: Percentage of patients aged 18 years and older with a diagnosis of chronic hepatitis C cirrhosis who underwent imaging with either ultrasound, contrast enhanced CT or MRI for hepatocellular carcinoma (HCC) at least once within the 12- N!A (Opioid) ! (Opioid) MIPSCQMs Specifications One-Time Screening for Hepatitis C Virns (HCV) for Patients at Risk: Percentage of patients aged 18 years and older with one or more of the following: a history of injection drug use, receipt of a blood transfusion prior to 1992, receiving maintenance hemodialysis OR birthdate in the years 19451965 who received one-time screening for . . Sfmt 4725 The percentage of adolescents 12 to 20 years of age with a primary care visit during the measurement year for whom tobacco use status was documented and received help with quitting if identified as a tobacco user. Opioid Therapy Follow-up Evaluation: All patients 18 and older prescribed opiates for longer than 6 weeks duration who had a followup evaluation conducted at least every 3 months during Opioid Therapy documented in the Documentation of Signed Opioid Treatment Agreement: All patients 18 and older prescribed opiates for longer than 6 weeks duration who signed an opioid treatment agreement at least once during Opioid Therapy documented in the medical record. Evaluation or Interview for Risk ofOpioid Misuse: All patients 18 and older prescribed opiates for longer than 6 weeks duration evaluated for risk of opioid misuse using a brief validated instrument (for example Opioid Risk Tool, SOAPP-R) or patient interview documented at least once during Opioid Therapy in the medical record. Osteoporosis Management in Women Who Had a Fracture: The percentage of women age 50-85 who suffered a fracture in the 6 months prior to the performance period through June 30 of the performance period and who either had a bone mineral density test or received a prescription for a drug to treat osteoporosis in the 6 months after the fracture. Preventive Care and Screening: Unhealthy Alcohol Use: Screening & Brief Counseling: Percentage of patients aged 18 years and older who were screened for unhealthy alcohol use method at least E:\FR\FM\23NOR3.SGM 23NOR3 National Committee for Quality Assurance American Academy of Neurology American Academy of Neurology American Academy of Neurology National Committee for Quality Assurance Physician Consortium for Performance Improvement Foundation ER23NO18.119</GPH> NIA Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60137 B.S. Family Medicine § ! (Patient Specifications, CMS Web Interface Measure Specifications, MIPSCQMs Specifications N!A 441 N!A MIPSCQMs Specifications Intermediate Outcome 0071 442 NIA MIPSCQMs Specifications Process amozie on DSK3GDR082PROD with RULES3 Effective Clinical Care Effective Clinical Care NIA 443 NIA MIPSCQMs Specifications Process Patient Safety NIA 444 NIA MIPSCQMs Specifications Process Efficiency and Cost Reduction ! (Efficiency) VerDate Sep<11>2014 Clinical Care 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00303 Fmt 4701 Sfmt 4725 The percentage of patients 18 years of age and older during the measurement year who were hospitalized and discharged from July 1 of the year prior to the measurement year to June 30 of the measurement year with a diagnosis of acute myocardial infarction (AMI) and who received were prescribed persistent beta-blocker treatment for 6 months after Non-Recommended Cervical Cancer Screening in Adolescent Females: The percentage of adolescent females 16-20 years of age screened unnecessarily for cervical cancer. Medication Management for People with Asthma (MMA): The percentage of patients 5-64 years of age during the measurement year who were identified as having persistent asthma and were dispensed appropriate medications that they E:\FR\FM\23NOR3.SGM 23NOR3 Medicare & Medicaid Services Wisconsin Collaborative for Healthcare Quality (WCHQ) National Committee for Quality Assurance National Committee for Quality Assurance National Committee for Quality Assurance ER23NO18.120</GPH> ! (Outcome) v2 received brief counseling if identified as an alcohol user. Therapy the Treatment of Cardiovascular Disease: Percentage of the following patients-all considered at high risk of cardiovascular events-who were prescribed or were on statin therapy during the measurement period: • Adults aged 2: 21 years who were previously diagnosed with or currently have an active diagnosis of clinical atherosclerotic cardiovascular disease (ASCVD); OR • Adults aged 2:21 years who have ever had a fasting or direct low-density lipoprotein cholesterol (LDL-C) level2: 190 mg/dL; OR • Adults aged 40-75 years with a diagnosis of diabetes with a fasting or direct LDL-C level of 70-189 Ischemic Vascular Disease All or None Outcome Measure (Optimal Control): The IVD All-or-None Measure is one outcome measure (optimal control). The measure contains four goals. All four goals within a measure must be reached in order to meet that measure. The numerator for the all-or-none measure should be collected from the organization's total IVD denominator. All-orNone Outcome Measure (Optimal Control)Using the IVD denominator optimal results include: • Most recent blood pressure (BP) measurement is less than or equal to 140/90 mmHg;and • Most recent tobacco status is Tobacco Free; and • Daily Aspirin or Other Antiplatelet Unless Contraindicated; and 60138 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.S. Family Medicine Otitis Media with Effusion (OME): Systemic Antimicrobials- Avoidance oflnappropriate Use: Percentage of patients aged 2 months through 12 years with a diagnosis ofOME who were not prescribed systemic antimicrobials. NIA 468 NIA (Opioid) 472 ! (Appropriate Use) CMS249 vI MIPS CQMs Specifications eCQM Specifications Process Effective Clinical Care Continuity of Pharmacotherapy for Opioid Use Disorder: Percentage of adults aged 18 years and older with pharmacotherapy for opioid use disorder (OUD) who have at least 180 days of Process Cost Reduction Factor Profile for Osteoporotic Fracture: Percentage of female patients aged 50 to 64 without select risk factors for osteoporotic fracture who received an order for a dual-energy x-ray absorptiometry (DXA) scan during the N/A 474 N/A MIPSCQMs Specifications Process California Centers Medicare& Medicaid Services Community/Pop ulation Health PPRNet Zoster (Shingles) Vaccination: The percentage of patients 50 years of age and older who have a Varicella Zoster (shingles) vaccination. Centers N!A 475 Community/Pop HIV Screening: CMS349 eCQM Process Percentage of patients 15-65 years of age who Disease vi Specifications ulation Health have ever been tested for human and Prevention virus Comment: One commenter indicated that opportunities to assess the immunization status of Medicare beneficiaries for should be done by the range of clinicians who care for them, including primary care and specialty clinicians. Taking advantage of each and every patient encounter to ensure that counseling and education on vaccines, based on their age and health status, and a strong clinician recommendation have been found to improve the likelihood of a patient being immunized. The commenter supported the inclusion of measure Q 110: Preventive Care and Screening Influenza Immunization and measure Q Ill: Pneumococcal Vaccination Status for Older Adults into a number of primary care and specialty quality measure sets. Prioritizing quality measures around immunizations will help close existing measure gaps, improve upon immunization rates and health outcomes for the millions of Medicare beneficiaries. A second commenter supported inclusion of measures Q II 0, Q Ill, Q394: Immunizations for Adolescents. Response: We thank the commenters for their support of measures QIIO, Q111, and Q394. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00304 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.121</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are fmalizing the Family Medicine Specialty Measure Set as proposed for the 2019 Performance Period and future year with the exception of the following newly proposed measures: Ischemic Vascular Disease Use of Aspirin or Anti-platelet Medication and Falls: Screening, Risk-Assessment, and Plan of Care to Prevent Future Falls. We are no longer fmalizing the inclusion of this IVD measure as it is duplicative of a component within Q441: Ischemic Vascular Disease All or None Outcome Measure (Optimal Control). We are no longer finalizing the inclusion of the composite falls measure because it must be fully vetted to utilize standardized tools that would appropriately identitY the at-risk patient population. In addition, as noted in our responses to public comments in Table C, measures Q048, QI54, QI55, and Q318 are not fmalized for removal from this measure set as will be retained in this measure set for the 2019 Performance Period and future Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60139 B.S. Family Medicine 0056 163 CMS123 v7 eCQM Specifications Effective Clinical Care Process Measure Specifications, eCQM Specifications, CMS Web Interface Measure Specifications, MIPSCQMs Specifications N/A N/A N/A 334 373 447 N/A CMS65v 8 N/A MIPSCQMs Specifications eCQM Specifications MIPSCQMs Specifications Efficiency Intermediate Outcome Process Efficiency and Cost Reduction Effective Clinical Care Community/ Population Health Comprehensive Diabetes Care: Foot Exam: The percentage of patients 18-75 years of age with diabetes (type 1 and type 2) who received a foot exam (visual inspection and sensory exam with mono filament and a pulse exam) during the measurement year. Use of Aspirin or Another Antiplatelet: Percentage of patients 18 years of age and older who were diagnosed with acute myocardial infarction (AMI), coronary artery bypass graft (CABG) or percutaneous coronary interventions (PCI) in the 12 months prior to the measurement period, or who had an active diagnosis of ischemic vascular disease (IVD) during the measurement period, and who had documentation of use of aspirin or another antiplatelet the measurement Adnlt Sinnsitis: More than One Compnterized Tomography (CT) Scan Within 90 Days for Chronic Sinusitis (Overuse): Percentage of patients aged 18 years and older with a diagnosis of chronic sinusitis who had more than one CT scan of the paranasal sinuses ordered or received within 90 days after the date of National American Academy of Otolaryngolo gy- Otolaryngolo gy- Head and Neck Surgery Hypertension: Improvement in Blood Pressure: Percentage of patients aged 18-85 years of age with a diagnosis of hypertension whose blood pressure improved during the measurement period. Centers for Chlamydia Screening and Follow Up: The percentage of female adolescents 16 years of age who had a chlamydia screening test with proper follow-up during the measurement period. National Committee for Quality Assurance Medicaid Services We did not receive specific comments regarding the proposed removal of measures from this specialty measure set. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00305 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.122</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are finalizing the removal of measures from the Family Medicine Specialty Measure Set as proposed for the 2019 Performance Period and future years. However, as noted in our responses to public comments in Table C, we are not fmalizing the following measures for removal from this measure set: Q048, Q154, Q155, and 60140 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.6. Internal Medicine In addition to the considerations discussed in the introductory language of Table Bin this final rule, the Internal Medicine specialty set takes into consideration the following criteria, which includes, but is not limited to: the measure reflects current clinical guidelines and the coding of the measure includes the specialists. We may reassess the appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. In addition, as outlined at the end of this table, we removed the following quality measures from the specialty set: Quality IDs: 163, 204, 276, 278, 334, 373, and 447. B.6. Internal Medicine 0059 amozie on DSK3GDR082PROD with RULES3 § VerDate Sep<11>2014 001 0081 005 0067 006 0070 Intermediate Outcome NIA MIPSCQMs Specifications eCQM Specifications, MIPSCQMs Specifications 007 Process Effective Clinical Care Process Effective Clinical Care Process Effective Clinical Care Diabetes: Hemoglobin Ale (HbAlc) Poor Control (>9%): Percentage of patients 18-75 years of age with diabetes who had hemoglobin Ale> 9.0 percent during the measurement period. National Connnittee for Quality Assurance Heart Failure (HF): AngiotensinConverting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) Therapy for Left Ventricular Systolic Dysfunction (LVSD): Percentage of patients aged 18 years and older with a diagnosis of heart failure (HF) with a current or prior left ventricular ejection fraction (L VEF) < 40 percent who were prescribed ACE inhibitor or ARB therapy either within a 12month period when seen in the outpatient OR at each Physician Consortium Performance Improvement Foundation (PCPI®) American Association Coronary Artery Disease (CAD): BetaBlocker Therapy-Prior Myocardial Infarction (MI) or Left Ventricular Systolic Dysfunction (LVEF <40%): Percentage of patients aged 18 years and older with a diagnosis of coronary artery disease seen within a 12-month period who also have prior MI OR a current or prior LVEF < 40 percent who were prescribed beta-blocker Physician Consortium Performance Improvement Foundation (PCPI®) 0083 008 CMS144v 7 eCQM Specifications, MIPSCQMs Specifications Process Effective Clinical Care Heart Failure (HF): Beta-Blocker Therapy for Left Ventricular Systolic Dysfunction (LVSD): Percentage of patients aged 18 years and older with a diagnosis of heart failure (HF) with a current or prior left ventricular ejection fraction (L VEF) < 40 percent who were prescribed beta-blocker therapy either within a 12-month period when seen in the outpatient Physician Consortium For Performance Improvement 0105 009 CMSI28v 7 eCQM Specifications Process Effective Clinical Care Anti-Depressant Medication Management: Percentage of patients 18 years of age and older who were treated with antidepressant medication, had a diagnosis of major and who remained on National Connnittee for Quality Assurance 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00306 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.123</GPH> ! (Outcome) Effective Clinical Care Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60141 B.6. Internal Medicine antidepressant medication treatment. Two rates are reported: a. Percentage of patients who remained on an antidepressant medication for at least 84 days (12 weeks). b. Percentage of patients who remained on an antidepressant medication for at least 180 days ! (Care Coordination) ! (Care Coordinatio n) N/A 024 N/A Medicare Part BClaims Measure Specifications, MIPSCQMs Specifications Process Communication and Care Coordination 0046 039 N/A Medicare Part BClaims Measure Specifications, MIPSCQMs Process Effective Clinical Care 0326 047 N/A Medicare Part BClaims Measure Specifications, MIPSCQMs Specifications Process N/A 048 N/A Medicare Part B Claims Measure Specifications, MIPSCQMs Specifications Part B Claims Measure Specifications, MIPSCQMs Specifications ! (Patient Experience) Communication with the Physician or Other Clinician Managing On-going Care Post-Fracture for Men and Women Aged 50 Years and Older: Percentage of patients aged 50 years and older treated for a fracture with documentation of communication, between the physician treating the fracture and the physician or other clinician managing the patient's on-going care, that a fracture occurred and that the patient was or should be considered for osteoporosis treatment or testing. This measure is reported by the physician who treats the fracture and who therefore is held accountable for the communication. Screening for Osteoporosis for Women Aged 65-85 Years of Age: Percentage of female patients aged 65-85 years of age who ever had a central dual-energy Xray absorptiometry (DXA) to check for National Committee for Quality Assurance Communication and Care Coordination Advance Care Plan: Percentage of patients aged 65 years and older who have an advance care plan or surrogate decision maker documented in the medical record or documentation in the medical record that an advance care plan was discussed but the patient did not wish or was not able to name a surrogate decision maker or provide an National Committee for Quality Assurance Process Effective Clinical Care National Committee for Quality Assurance Process Person Caregiver Centered Experience and Outcomes Urinary Incontinence: Assessment of Presence or Absence of Urinary Incontinence in Women Aged 65 Years and Older: Percentage of female patients aged 65 years and older who were assessed for the presence or absence of urinary incontinence within 12 months. Urinary Incontinence: Plan of Care for Urinary Incontinence in Women Aged 65 Years and Older: Percentage of female patients aged 65 years and older with a diagnosis of urinary incontinence with a documented plan of care for urinary incontinence at least once within 12 months. Acute Otitis Externa (AOE): Topical Therapy: Percentage of patients aged 2 years and older with a diagnosis of AOE who were prescribed topical preparations. National Committee for Quality Assurance Committee for Quality Assurance VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00307 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.124</GPH> amozie on DSK3GDR082PROD with RULES3 Process 60142 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.6. Internal Medicine 0041 110 CMS147v 8 Medicare Part B Claims Measure Specifications, eCQM Specifications, CMS Web Interface Measure Specifications, MIPSCQMs Process Community/ Population Health * NIA 111 CMS127v 7 Medicare Part B Claims Measure Specifications, eCQM Specifications, MIPSCQMs Process Community/ Population Health § ! 0058 116 MIPSCQMs Specifications Process CMSl3lv 7 Part BClaims Measure Specifications, eCQM Specifications, MIPSCQMs Process Cost Reduction (Appropriat e Use) 0055 117 § § 119 CMSl34v 7 eCQM Specifications, MIPSCQMs Specifications Process Effective Clinical Care 0417 126 NIA MIPSCQMs Specifications Process Effective Clinical Care Medicare Part B Claims Measure Specifications, eCQM Specifications, MIPSCQMs Specifications Process 0421 amozie on DSK3GDR082PROD with RULES3 VerDate Sep<11>2014 Clinical Care 0062 § 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Pneumococcal Vaccination Status for Older Adults: Percentage of patients 65 years of age and older who have ever received a pneumococcal vaccine Frm 00308 Avoidance of Antibiotic Treatment in Adults with Acute Bronchitis: Percentage of adults 18-64 years of age with a diagnosis of acute bronchitis who were not dispensed an antibiotic Diabetes: Eye Exam: Percentage of patients 18-75 years of age with diabetes who had a retinal or dilated eye exam by an eye care professional during the measurement period or a negative retinal exam (no evidence of retinopathy) in the 12 months prior to the measurement period. Diabetes: Medical Attention for Nephropathy: The percentage of patients 18-75 years of age with diabetes who had a nephropathy screening test or evidence of nephropathy the measurement Diabetes Mellitus: Diabetic Foot and Ankle Surgery Physician Consortium for Performance Improvement Foundation (PCPI®) National Committee for Quality Assurance Committee for Quality Assurance National Committee for Quality Assurance American Podiatric Medical Association for Medicare & Medicaid Services Population Health parameters, a follow-up plan is documented during the encounter or during the previous 12 months of the current encounter. Normal Parameters: Age 18 years and older BMI => 18.5 and< 25 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.125</GPH> A Inappropriate Use: Percentage of patients aged 2 years and older with a diagnosis of AOE who were not prescribed systemic antimicrobial Preventive Care and Screening: Influenza Immunization: Percentage of patients aged 6 months and older seen for a visit between October l and March 31 who received an influenza immunization OR who reported previous receipt of an influenza immunization. Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60143 B.6. Internal Medicine ! (Patient Safety) ! (Care Coordinatio n) ! (Patient Safety) 0419 130 CMS68v8 Medicare Part B Claims Measure Specifications, eCQM Specifications, MIPSCQMs Specifications Process Patient Safety Documentation of Current Medications in the Medical Record: Percentage of visits for patients aged 18 years and older for which the eligible professional or eligible clinician attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list must include ALL known prescriptions, over-the-counters, herbals, and vitamin/mineralldietary (nutritional) supplements AND must contain the medications' name, dosage, frequency and Centers for Medicare & Medicaid Services 0418 134 CMS2v8 Medicare Part B Claims Measure Specifications, eCQM Specifications, CMSWeb Interface Measure Specifications, MIPSCQMs Process Community/ Population Health Preventive Care and Screening: Screening for Depression and Follow-Up Plan: Percentage of patients aged 12 years and older screened for depression on the date of the encounter using an age appropriate standardized depression screening tool AND if positive, a follow-up plan is documented on the date of the positive screen. Centers for Medicare & Medicaid Services 154 N/A Medicare Part B Claims Measure Specifications, MIPSCQMs Process Patient Safety Falls: Risk Assessment: Percentage of patients aged 65 years and older with a history of falls who had a risk assessment for falls completed within 12 months. National Committee for Quality Assurance 155 N/A Medicare Part BClaims Measure Specifications, MIPSCQMs Process Communicatio nand Care Coordination Falls: Plan of Care: Percentage of patients aged 65 years and older with a history of falls who had a plan of care for falls documented within 12 months. National Committee for Quality Assurance N/A 181 N/A Medicare Part BClaims Measure Specifications, MIPSCQMs Specifications Process Patient Safety Centers for Medicare & Medicaid Services 0028 226 CMS138v Medicare Part B Claims Measure Specifications, eCQM Specifications, CMSWeb Interface Measure Specifications, MIPSCQMs Specifications Process Community/ Population Health Outcome Clinical Care Elder Maltreatment Screen and Follow-Up Plan: Percentage of patients aged 65 years and older with a documented elder maltreatment screen using an Elder Maltreatment Screening Tool on the date of encounter AND a documented follow-up plan on the date of the positive screen. Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: a. Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months. b. Percentage of patients aged 18 years and older who were screened for tobacco use and identified as a tobacco user who received tobacco cessation intervention. c. Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user. Controlling High Blood Pressure: Percentage of patients 18-85 years of age who 0101 0101 7 § 0018 236 CMS165v Part amozie on DSK3GDR082PROD with RULES3 7 VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00309 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 Physician Consortium for Performance Improvement Foundation (PCPI®) for ER23NO18.126</GPH> ! (Patient Safety) 60144 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.6. Internal Medicine Assurance 0022 238 CMS156v 7 eCQM Specifications, MIPSCQMs Specifications Process Patient Safety Use of High-Risk Medications in the Elderly: Percentage of patients 65 years of age and older who were ordered high-risk medications. Two rates are reported. a. Percentage of patients who were ordered at least one high-risk medication. b. Percentage of patients who were ordered at National Committee for Quality Assurance 0643 243 NIA MIPSCQMs Specifications Process Communicatio nand Care Coordination American Heart Association N/A 277 N/A MIPSCQMs Specifications Process Effective Clinical Care N/A 279 N/A MIPSCQMs Specifications Process Effective Clinical Care Cardiac Rehabilitation Patient Referral from an Outpatient Setting: Percentage of patients evaluated in an outpatient setting who within the previous 12 months have experienced an acute myocardial infarction (MI), coronary artery bypass graft (CABG) surgery, a percutaneous coronary intervention (PCI), cardiac valve surgery, or cardiac transplantation, or who have chronic stable angina (CSA) and have not already participated in an early outpatient cardiac rehabilitation/secondary prevention (CR) program for the qualiJying event/ diagnosis who were referred to a CR Sleep Apnea: Severity Assessment at Initial Diagnosis: Percentage of patients aged 18 years and older with a diagnosis of obstructive sleep apnea who had an apnea hypopnea index (AHI) or a respiratory disturbance index (RDI) measured at the time of initial Sleep Apnea: Assessment of Adherence to Positive Airway Pressure Therapy: Percentage of visits for patients aged 18 years and older with a diagnosis of obstructive sleep apnea who were prescribed positive airway pressure therapy who had documentation that adherence to positive airway pressure therapy ! (Opioid) 0004 305 CMS137v 7 eCQM Specifications Process Effective Clinical Care Initiation and Engagement of Alcohol and Other Drug Dependence Treatment: Percentage of patients 13 years of age and older with a new episode of alcohol and other drug (AOD) dependence who received the following. Two rates are reported. • Percentage of patients who initiated treatment within 14 days of the diagnosis. • Percentage of patients who initiated treatment and who had two or more additional services with an AOD diagnosis National Committee for Quality Assurance § 0032 309 CMS124v 7 eCQM Specifications Process Effective Clinical Care Cervical Cancer Screening: Percentage of women 21---{;4 years of age who were screened for cervical cancer using either National Committee for Quality ! (Patient Safety) (Care Coordinatio n) amozie on DSK3GDR082PROD with RULES3 blood pressure was adequately controlled (<140/90mmHg) during the measurement period. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00310 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 American Academy of Sleep Medicine American Academy of Sleep Medicine ER23NO18.127</GPH> Specifications, eCQM Specifications, CMSWeb Interface Measure Specifications, MIPSCQMs Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60145 B.6. Internal Medicine 317 CMS22v7 § ! (Patient Experience) 1525 amozie on DSK3GDR082PROD with RULES3 ! (Appropriat e Use) VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 Medicare Part B Claims Measure Specifications, eCQM Specifications, MIPSCQMs Specifications Process approved Survey Vendor Engagement/ Experience Part B Claims Measure Specifications, MIPSCQMs Specifications Process MIPSCQMs Specifications Process PO 00000 Community/ Population Health Preventive Care and Screening: Screening for High Blood Pressure and Follow-Up Documented: Percentage of patients aged 18 years and older seen during the reporting period who were screened for high blood pressure AND a recommended follow-up plan is documented based on the current blood pressure (BP) as indicated. Falls: Screening for Future Fall Risk: Percentage of patients 65 years of age and older who were screened for future fall risk during the measurement period. Person CaregiverCentered Experience and Outcomes CAHPS for MIPS Clinician/Group Survey: The Consumer Assessment of Healthcare Providers and Systems (CAHPS) for MIPS Clinician/Group Survey is comprised of 10 Summary Survey Measures (SSMs) and measures patient experience of care within a group practice. The NQF endorsement status and endorsement id (if applicable) for each SSM utilized in this measure are as follows: • Getting Timely Care, Appointments, and Information; (Not endorsed by NQF) • How well Providers Communicate; (Not endorsed by NQF) • Patient's Rating of Provider; (NQF endorsed # 0005) • Access to Specialists; (Not endorsed by NQF) • Health Promotion and Education; (Not endorsed by NQF) • Shared Decision-Making; (Not endorsed by NQF) • Health Status and Functional Status; (Not endorsed by NQF) • Courteous and Helpful Office Staff; (NQF endorsed # 0005) • Care Coordination; (Not endorsed by NQF) • • Stewardship of Patient Resources. (Not endorsed Atrial Fibrillation and Atrial Flutter: Chronic Anticoagulation Therapy: Percentage of patients aged 18 years and older with nonvalvular atrial fibrillation (AF) or atrial flutter who were prescribed warfarin OR another FDA- approved anticoagulant drug for the prevention of thromboembolism during the measurement Adult Sinusitis: Antibiotic Prescribed for Clinical Care Frm 00311 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 Centers for Medicare & Medicaid Services Healthcare Research & Quality (AHRQ) Centers for Medicare & Medicaid Services Association ER23NO18.128</GPH> N/A 60146 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.6. Internal Medicine Clavulanate Prescribed for Patients with Acute Bacterial Sinusitis (Appropriate Use): Percentage of patients aged 18 years and older with a diagnosis of acute bacterial sinusitis that were prescribed amoxicillin, with or without Clavulanate, as a first line antibiotic at the time N/A 333 N/A MIPSCQMs Specifications Efficiency Efficiency and Cost Reduction Adult Sinusitis: Computerized Tomography (CT) for Acute Sinusitis (Overuse): Percentage of patients aged 18 years and older with a diagnosis of acute sinusitis who had a computerized tomography (CT) scan of the paranasal sinuses ordered at the time of diagnosis or received within 28 days after date American Academy of Otolaryngology -Head and Surgery N/A 337 N/A MIPSCQMs Specifications Process Effective Clinical Care American Academy of Dermatology § ! (Outcome) 2082 338 N/A MIPSCQMs Specifications Outcome Effective Clinical Care ! (Outcome) N/A 342 N/A MIPSCQMs Specifications Outcome Person and CaregiverCentered Experience and Outcomes * 0710 370 CMS159v 7 eCQM Specifications, CMSWeb Interface Measure Specifications, MIPSCQMs Outcome Effective Clinical Care Psoriasis: Tuberculosis (TB) Prevention for Patients with Psoriasis, Psoriatic Arthritis and Rheumatoid Arthritis on a Biological Immune Response Modifier: Percentage of patients, regardless of age, with Psoriasis, Psoriatic Arthritis and Rheumatoid Arthritis on a Biological Immune Response Modifier whose providers are ensuring active tuberculosis prevention either through yearly negative standard tuberculosis screening tests or are reviewing the patient's history to determine if they have had appropriate for a recent or test HIV Viral Load Suppression: The percentage of patients, regardless of age, with a diagnosis ofHIV with a HIV viral load less than 200 copies/mL at last HIV viral load test the measurement Pain Brought Under Control Within 48 Hours: Patients aged 18 and older who report being uncomfortable because of pain at the initial assessment (after admission to palliative care services) who report pain was brought to a comfortable level within 48 hours. Depression Remission at Twelve Months: The percentage of adolescent patients 12 to 17 years of age and adult patientsl8 years of age or older with major depression or dysthymia who reached remission 12 months(+/- 60 days) after an index event date. 0712 371 CMS160v 7 eCQM Specifications Process Effective Clinical Care Depression Utilization of the PHQ-9 Tool: The percentage of adolescent patients (12 to 17 years of age) and adult patients (18 years of age or older) with a diagnosis of major depression or dysthymia who have a completed PHQ-9 or PHQ-9M tool during the MN Community Measurement N/A 374 CMS50v7 eCQM Specifications, MIPSCQMs Specifications Process Communicatio nand Care Coordination Closing the Referral Loop: Receipt of Specialist Report: Percentage of patients with referrals, regardless of age, for which the referring provider receives a report from the provider to Centers for Medicare & Medicaid Services § ! (Outcome) amozie on DSK3GDR082PROD with RULES3 ! (Care Coordinatio n) VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00312 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 Health Resources and Services Administration National Hospice and Palliative Care Organization MN Community Measurement ER23NO18.129</GPH> ! (Appropriat e Use) Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60147 B.6. Internal Medicine ! (Outcome) ! (Outcome) amozie on DSK3GDR082PROD with RULES3 VerDate Sep<11>2014 Services 1879 383 N/A MIPSCQMs Specifications Intermediate Outcome Patient Safety Adherence to Antipsychotic Medications for Individuals with Schizophrenia: Percentage of individuals at least 18 years of age as of the beginning of the measurement period with schizophrenia or schizoaffective disorder who had at least two prescriptions filled for any antipsychotic medication and who had a Proportion of Days Covered (PDC) of at least 0.8 for antipsychotic medications during the measurement period (12 Health Services Advisory Group N/A 387 N/A MIPSCQMs Specifications Process Effective Clinical Care Annual Hepatitis C Virus (HCV) Screening for Patients who are Active Injection Drug Users: Percentage of patients regardless of age who are active injection drug users who received screening for HCV infection within the Physician Consortium for Performance Improvement Foundation (PCPI®) N/A 398 N/A MIPSCQMs Specifications Outcome Effective Clinical Care Optimal Asthma Control: Composite measure of the percentage of pediatric and adult patients whose asthma is well-controlled as demonstrated by one of three age appropriate patient reported outcome tools. Minnesota Community Measurement MIPSCQMs Specifications Process § § CaregiverCentered Experience and Outcomes Specifications Clinical Care N/A 401 N/A MIPSCQMs Specifications Process Effective Clinical Care N/A 402 N/A MIPSCQMs Specifications Process Community/ Population Health 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00313 Fmt 4701 Sfmt 4725 One-Time Screening for Hepatitis C Virus (HCV) for Patients at Risk: Percentage of patients aged 18 years and older with one or more of the following: a history of injection drug use, receipt of a blood transfusion prior to 1992, receiving maintenance hemodialysis OR birthdate in the years 1945-1965 who received one-time screening for hepatitis C virus (HCV) infection. Hepatitis C: Screening for Hepatocellular Carcinoma (HCC) in Patients with Cirrhosis: Percentage of patients aged 18 years and older with a diagnosis of chronic hepatitis C cirrhosis who underwent imaging with either ultrasound, contrast enhanced CT or MRI for hepatocellular carcinoma (HCC) at least once within the 12-month submission period. Tobacco Use and Help with Quitting Among Adolescents: The percentage of adolescents 12 to 20 years of age with a primary care visit during the measurement year for whom tobacco use status was documented and received help with E:\FR\FM\23NOR3.SGM 23NOR3 Consortium for Performance Improvement Foundation (PCPI®) American Gastroenterological Association/ American Society for Gastrointestinal Endoscopy/ American College of GastroNational Committee for Quality Assurance ER23NO18.130</GPH> ! (Patient Experience) 60148 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.6. Internal Medicine N/A 408 N/A MIPSCQMs Specifications Process Effective Clinical Care ! (Opioid) N/A 412 N/A MIPSCQMs Specifications Process Effective Clinical Care ! (Opioid) N/A 414 N/A MIPSCQMs Specifications Process Effective Clinical Care 0053 418 N/A Medicare Part BClaims Measure Specifications, MIPSCQMs Specifications Process Effective Clinical Care 2152 431 MIPSCQMs Specifications Process CMS347v 2 eCQM Specifications, CMSWeb Interface Measure Specifications, MIPSCQMs Specifications Process N/A MIPSCQMs Specifications Intermediate Outcome 438 amozie on DSK3GDR082PROD with RULES3 ! (Outcome) VerDate Sep<11>2014 N!A 441 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Population Health Clinical Care Frm 00314 Fmt 4701 Effective Clinical Care Sfmt 4725 Opioid Therapy Follow-up Evaluation: All patients 18 and older prescribed opiates for longer than 6 weeks duration who had a follow-up evaluation conducted at least every 3 months during Opioid Therapy documented in the medical record. Documentation of Signed Opioid Treatment Agreement: All patients 18 and older prescribed opiates for longer than 6 weeks duration who signed an opioid treatment agreement at least once during Opioid Therapy documented in the medical record. Evaluation or Interview for Risk of Opioid Misuse: All patients 18 and older prescribed opiates for longer than 6 weeks duration evaluated for risk of opioid misuse using a brief validated instrument (for example Opioid Risk Tool, SOAPP-R) or patient interview documented at least once during Opioid Therapy in the medical record. Osteoporosis Management in Women Who Had a Fracture: The percentage of women age 50-85 who suffered a fracture in the 6 months prior to the performance period through June 30 of the performance period and who either had a bone mineral density test or received a prescription for a drug to treat osteoporosis in the 6 months Preventive Care and Screening: Unhealthy Alcohol Use: Screening & Brief Counseling: Percentage of patients aged 18 years and older who were screened for unhealthy alcohol use using a systematic screening method at least once within the last 24 months AND who received brief counseling if identified as an alcohol user. Statio Therapy for the Prevention and Treatment of Cardiovascular Disease: Percentage of the following patients: all considered at high risk of cardiovascular events who were prescribed or were on statio therapy during the measurement period: • Adults aged 2:: 21 years who were previously diagnosed with or currently have an active diagnosis of clinical atherosclerotic cardiovascular disease(ASCVD); OR • Adults aged 2::21 years who have ever had a fasting or direct low-density lipoprotein cholesterol (LDL-C) level::O: 190 mg/dL; OR • Adults aged 40-75 years with a diagnosis of diabetes with a fasting or direct LDL-C level of70-189 Ischemic Vascular Disease All or None Outcome Measure (Optimal Control): The IVD Ali-or-None Measure is one outcome measure (optimal control). The measure contains four goals. All four goals within a measure must be reached in order to meet that E:\FR\FM\23NOR3.SGM 23NOR3 American Academy of Neurology American Academy of Neurology American Academy of Neurology National Committee for Quality Assurance Physician Consortium for Performance Improvement Foundation (PCPI®) Centers Medicare & Medicaid Services Wisconsin Collaborative for Healthcare Quality (WCHQ) ER23NO18.131</GPH> ! (Opioid) Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60149 B.6. Internal Medicine 0071 442 N/A § ! (Patient Safety) § N/A 444 NA ! (Efficiency) MIPSCQMs Specifications Process MIPSCQMs Specifications Process MIPSCQMs Specifications Process Effective Clinical Care Screening in Adolescent Females: The percentage of adolescent females 16-20 years of age screened unnecessarily for and Cost Reduction Process Clinical Care Process (Appropriat e Use) amozie on DSK3GDR082PROD with RULES3 N/A VerDate Sep<11>2014 475 CMS349v 1 19:26 Nov 21, 2018 Jkt 247001 Specifications Cost Reduction Specifications Population Health eCQM Specifications PO 00000 National Committee for Quality Assurance Community/Po pulation Health Process Frm 00315 Fmt 4701 Sfmt 4725 Medication Management for People with Asthma (MMA): The percentage of patients 5-64 years of age during the measurement year who were identified as having persistent asthma and were dispensed appropriate medications that they remained on for at least 75 percent of their treatment Continuity of Pharmacotherapy for Opioid Use Disorder: Percentage of adults aged 18 years and older with pharmacotherapy for opioid use disorder (OUD) who have at least 180 days of continuous treatment. Appropriate Use ofDXA Scans in Women Under 65 Years Who Do Not Meet the Risk Factor Profile for Osteoporotic Fracture: Percentage of female patients aged 50 to 64 without select risk factors for osteoporotic fracture who received an order for a dualenergy x-ray absorptiometry (DXA) scan the measurement Zoster (Shingles) Vaccination: The percentage of patients 50 years of age and older who have a Varicella Zoster (shingles) vaccination. HIV Screening: Percentage of patients 15-65 years of age who have ever been tested for human E:\FR\FM\23NOR3.SGM 23NOR3 Committee for Quality Assurance Medicare & Medicaid Services Centers Disease and Prevention ER23NO18.132</GPH> § measure should be collected from the organization's total IVD denominator. All-orNone Outcome Measure (Optimal Control)Using the IVD denominator optimal results include: • Most recent blood pressure (BP) measurement is less than or equal to 140/90 mmHg;and • Most recent tobacco status is Tobacco Free; and • Daily Aspirin or Other Antiplatelet Unless Contraindicated; and • Statin Use Unless Contraindicated. Persistent Beta Blocker Treatment After a Heart Attack: The percentage of patients 18 years of age and older during the measurement year who were hospitalized and discharged from July 1 of the year prior to the measurement year to June 30 the measurement year with a diagnosis of acute myocardial infarction (AMI) and who received were prescribed persistent beta-blocker treatment for 6 months after 60150 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations Comment: One commenter supported measure Q277: Sleep Apnea: Severity Assessment at Initial Diagnosis and measure Q279: Sleep Apnea: Assessment of Adherence to Positive Airway Pressure Therapy in this measure set. Response: We thank the commenter for their support. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00316 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.133</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are finalizing the Internal Medicine Specialty Measure Set as proposed for the 2019 Performance Period and future year with the exception of the following newly proposed measures: Ischemic Vascular Disease Use of Aspirin or Anti-platelet Medication and Falls: Screening, Risk-Assessment, and Plan of Care to Prevent Future Falls. We are no longer finalizing the inclusion of this IVD measure as it is duplicative of a component within Q441: Ischemic Vascular Disease All or None Outcome Measure (Optimal Control). We are no longer finalizing the inclusion of the composite falls measure because it must be fully vetted to utilize standardized tools that would appropriately identiJy the at-risk patient population. In addition, as noted in our responses to public comments in Table C, measures Q048, Ql54, Ql55, and Q318 are not finalized for removal from this measure set as proposed; therefore, they will be retained in this measure set for the 2019 Performance Period and future years. Please note that measures Q468, Q472, Q474, and Q475 were included in the proposed rule for this specialty set; however, they did not have Quality# IDs at the time they were published in the proposed rule because they were new measures. They were included at the beginning of this specialty measure set table in the proposed rule with "TBD" as the Quality# IDs. Therefore, in this fmal rule, we replaced "TBD" with the assigned Quality# IDs Q468, Q472, Q474, and Q475, which were established for these new measures subsequent to the proposed rule publication and included these measures at the end of this measure set table in ascending order. Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60151 B.14. Physical Medicine In addition to the considerations discussed in the introductory language of Table Bin this final rule, the Physical Medicine specialty set takes into consideration the following criteria, which includes, but is not limited to: the measure reflects current clinical guidelines and the coding of the measure includes the specialists. CMS may re-assess the appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. This measure set does not have any measures removed from prior years. B.14. Physical Medicine 0326 ! (Patient Experience) N/A * 0421 ! (Patient Safety) 047 N/A Medicare Part B Claims Measure Specifications, MIPSCQMs Specifications Process Communication and Care Coordination N/A Medicare Part BCiaims Measure Specifications, MIPSCQMs Process Person and CaregiverCentered Experience and Outcomes 128 CMS69 v7 Medicare Part BCiaims Measure Specifications, eCQM Specifications, MIPSCQMs Specifications Process 0419 130 CMS68 v8 Medicare Part BClaims Measure Specifications, eCQM Specifications, MIPSCQMs Specifications ! (Care Coordination) 0420 131 N/A Medicare Part BClaims Measure Specifications, MIPSCQMs ! (Patient Safety) 0101 154 N/A 109 amozie on DSK3GDR082PROD with RULES3 § VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Advance Care Plan: Percentage of patients aged 65 years and older who have an advance care plan or surrogate decision maker documented in the medical record or documentation in the medical record that an advance care plan was discussed but the patient did not wish or was not able to name a surrogate decision maker or provide an advance care Osteoarthritis (OA): Function and Pain Assessment: Percentage of patient visits for patients aged 21 years and older with a diagnosis of osteoarthritis (OA) with assessment for National Committee for Quality Assurance Community/Pop u1ation Health Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up Plan: Percentage of patients aged 18 years and older with a BMI documented during the current encounter or during the previous 12 months AND with a BMI outside of normal parameters, a follow-up plan is documented during the encounter or during the previous 12 months of the current encounter. Normal Parameters: Age 18 years and older BMI => 18.5 and< 25 Centers for Medicare& Medicaid Services Process Patient Safety Centers for Medicare & Medicaid Services Process Communication and Care Coordination Documentation of Current Medications in the Medical Record: Percentage of visits for patients aged 18 years and older for which the eligible professional or eligible clinician attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list must include ALL known prescriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutritional) supplements AND must contain the medications' name, dosage, frequency and route of administration. Pain Assessment and Follow-Up: Percentage of visits for patients aged 18 years and older with documentation of a pain assessment using a standardized tool(s) on each visit AND documentation of a follow-up Process Patient Safety Frm 00317 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM American Academy of Orthopedic Surgeons Centers for Medicare & Medicaid Services National Committee for Quality Assurance 23NOR3 ER23NO18.134</GPH> ! (Care Coordination) 60152 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.14. Physical Medicine ! BClaims Measure Specifications, MIPSCQMs Functional Outcome Assessment: Percentage of visits for patients aged 18 years and older with documentation of a current functional outcome assessment using a standardized functional outcome assessment tool on the date of encounter AND documentation of a care plan based on identified functional outcome deficiencies on the date of the identified deficiencies. Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: a. Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months. b. Percentage of patients aged 18 years and older who were screened for tobacco use and identified as a tobacco user who received tobacco cessation intervention. c. Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user. Preventive Care and Screening: Screening for High Blood Pressure and Follow-Up Documented: Percentage of patients aged 18 years and older seen during the reporting period who were screened for high blood pressure AND a recommended follow-up plan is documented based on the current blood pressure (BP) as indicated. Closing the Referral Loop: Receipt of Specialist Report: Percentage of patients with referrals, regardless of age, for which the referring provider receives a report from the provider to whom was referred. Tobacco Use and Help with Quitting Among Adolescents: The percentage of adolescents 12 to 20 years of age with a primary care visit during the measurement year for whom tobacco use status was documented and received help with if identified as a tobacco user. Therapy Follow-up All patients 18 and older prescribed opiates for longer than 6 weeks duration who had a follow-up evaluation conducted at least every 3 months during Opioid Therapy documented in the medical record. Documentation of Signed Opioid Treatment Agreement: All patients 18 and older prescribed opiates for longer than 6 weeks duration who signed an opioid treatment agreement at least once documented in the Centers for Medicare& Medicaid Services N/A Medicare Part BClaims Measure Specifications, MIPSCQMs Specifications Process Communication and Care Coordination 0028 226 CMS13 8v7 Medicare Part BCiaims Measure Specifications, eCQM Specifications, CMSWeb Interface Measure Specifications, MIPSCQMs Specifications Process Community/ Population Health 317 CMS22 v7 Part BClaims Measure Specifications, eCQM Specifications, MIPSCQMs Specifications Process /Population Health N/A 374 CMS50 v7 eCQM Specifications, MIPSCQMs Specifications Process Communication and Care Coordination N/A 402 N/A MIPSCQMs Specifications Process Community/ Population Health (Care Coordination) (Opioid) Specifications N/A 412 N/A (Opioid) amozie on DSK3GDR082PROD with RULES3 Committee for Quality Assurance 182 ! VerDate Sep<11>2014 Percentage of patients aged 65 years and older with a history of falls who had a plan of care for falls documented within 12 months. 2624 (Care Coordination) ! and Care Coordination 19:26 Nov 21, 2018 Jkt 247001 MIPSCQMs Specifications PO 00000 Effective Clinical Care Process Frm 00318 Fmt 4701 Effective Clinical Care Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 Physician Consortium for Performance Improvement Foundation (PCPI®) Centers Medicare & Medicaid Services Centers for Medicare& Medicaid Services National Committee for Quality Assurance Academy of Neurology American Academy of Neurology ER23NO18.135</GPH> (Care Coordination) Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60153 B.14. Physical Medicine ! (Opioid) Effective Clinical Care 2152 431 N/A ! (Opioid) MIPSCQMs Specifications Process MIPSCQMs Specifications Process Community/ Population Health Clinical Care Evaluation or Interview for Risk ofOpioid Misuse: All patients 18 and older prescribed opiates for longer than 6 weeks duration evaluated for risk of opioid misuse using a brief validated instrument (for example, Opioid Risk Tool, SOAPP-R) or patient interview documented at least once during Opioid Therapy in the medical record. Preventive Care and Screening: Unhealthy Alcohol Use: Screening & Brief Counseling: Percentage of patients aged 18 years and older who were screened for unhealthy alcohol use using a systematic screening method at least once within the last 24 months AND who received brief counseling if identified as an alcohol user. Continuity of Pharmacotherapy for Opioid Use Disorder: Percentage of adults aged 18 years and older with pharmacotherapy for opioid use disorder (OUD) who have at least 180 days of continuous treatment. American Academy of Neurology Physician Consortium for Performance Improvement Foundation (PCPI®) Southern California We did not receive specific comments regarding the measures included in this specialty measure set. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00319 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.136</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are finalizing the Physical Medicine Specialty Measure Set as proposed for the 2019 Performance Period and future years with the exception of the newly proposed composite measure: Falls: Screening, Risk-Assessment, and Plan of Care to Prevent Future Falls. We are no longer finalizing the inclusion of the composite falls measure because it must be fully vetted to utilize standardized tools that would appropriately identify the at-risk patient population. In addition, as noted in our responses to public comments in Table C, measures Q154 and Q155 are not finalized for removal from this measure set as proposed; therefore, they will be retained in this measure set for the 2019 Performance Period and future 60154 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.15. Preventive Medicine In addition to the considerations discussed in the introductory language of Table Bin this final rule, the Preventive Medicine specialty set takes into consideration the following criteria, which includes, but is not limited to: the measure reflects current clinical guidelines and the coding of the measure includes the specialists. CMS may reassess the appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. In addition, as outlined at the end ofthis table, we removed the following quality measures from the specialty set: Quality IDs: 014. B.l5. Preventive Medicine 0059 001 CMS122 v7 Medicare Part BClaims Measure Specifications, CMS Web Interface Measure Specifications, MIPS CQMs Specifications, eCQM Intermedi ate Outcome Effective Clinical Care Diabetes: Hemoglobin Ale (HbAlc) Poor Control(> 9%): Percentage of patients 18-75 years of age with diabetes who had hemoglobin Ale> 9.0 percent during the measurement period. National Committee for Quality Assurance N/A 024 N/A Medicare Part BClaims Measure Specifications, MIPSCQMs Specifications Process Communication and Care Coordination Communication with the Physician or Other Clinician Managing On-going Care PostFracture for Men and Women Aged 50 Years and Older: Percentage of patients aged 50 years and older treated for a fracture with documentation of communication, between the physician treating the fracture and the physician or other clinician managing the patient's on-going care, that a fracture occurred and that the patient was or should be considered for osteoporosis treatment or testing. This measure is reported by the physician who treats the fracture and who therefore is held accountable for the National Committee for Quality Assurance 0046 039 N/A Medicare Part B Claims Measure Specifications, MIPS CQMs Process Effective Clinical Care Screening for Osteoporosis for Women Aged 65-85 Years of Age: Percentage of female patients aged 65-85 years of age who ever had a central dual-energy X-ray absorptiometry (DXA) to check for National Committee for Quality Assurance 0326 047 N/A Medicare Part BClaims Measure Specifications, MIPS CQMs Specifications Process Communication and Care Coordination National Committee for Quality Assurance N/A 048 N/A Medicare Part B Claims Measure Specifications, MIPS CQMs Specifications Process Effective Clinical Care Advance Care Plan Percentage of patients aged 65 years and older who have an advance care plan or surrogate decision maker documented in the medical record or documentation in the medical record that an advance care plan was discussed but the patient did not wish or was not able to name a surrogate decision maker or provide an advance care Urinary Incontinence: Assessment of Presence or Absence of Urinary Incontinence in Women Aged 65 Years and Older: Percentage of female patients aged 65 years and older who were assessed for the presence or absence of urinary incontinence within 12 N/A 109 N/A Medicare Part B Claims Measure Specifications, MIPS Process Person and CaregiverCentered Experience and Outcomes ! (Outcome) ! (Care Coordination) ! (Care Coordination) amozie on DSK3GDR082PROD with RULES3 ! (Patient Experience) VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00320 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM National Committee for Quality Assurance American Academy of Orthopedic Surgeons 23NOR3 ER23NO18.137</GPH> § Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60155 B.15. Preventive Medicine Measure Specifications, eCQM Specifications, CMSWeb Interface Measure Specifications, MIPS CQMs * NIA 111 CMS127 v7 Medicare Part B Claims Measure Specifications, eCQM Specifications, MIPS CQMs Process Community/ Population Health Pneumococcal Vaccination Status for Older Adults: Percentage of patients 65 years of age and older who have ever received a pneumococcal vaccine. National Committee for Quality Assurance § 2372 112 CMS125 v7 Medicare Part BClaims Measure Specifications, eCQM Specifications, CMS Web Interface Measure Specifications, MIPS CQMs Process Effective Clinical Care Breast Cancer Screening: Percentage of women 51 - 74 years of age who had a mammogram to screen for breast cancer. National Committee for Quality Assurance 0034 113 CMS130 v7 Part B Claims Measure Specifications, eCQM Specifications, CMSWeb Interface Measure Specifications, MIPS CQMs Process § Clinical Care Colorectal Cancer Screening: Percentage patients 50 - 75 years of age who had appropriate screening for colorectal cancer. Committee for Quality Assurance § ! (Appropriate Use) 0058 116 NIA MIPSCQMs Specifications Process Efficiency and Cost Reduction Avoidance of Antibiotic Treatment in Adults with Acute Bronchitis: Percentage of adults 18-64 years of age with a diagnosis of acute bronchitis who were not dispensed an antibiotic National Committee for Quality Assurance § 0062 119 CMS134 v7 eCQM Specifications, MIPS CQMs Specifications Process Effective Clinical Care Diabetes: Medical Attention for Nephropathy: The percentage of patients 18-75 years of age with diabetes who had a nephropathy screening test or evidence of nephropathy during the measurement Diabetes Mellitus: Diabetic Foot and Ankle Care, Peripheral Neuropathy-Neurological Evaluation: Percentage of patients aged 18 years and older with a diagnosis of diabetes mellitus who had a neurological examination of their lower extremities within 12 months. National Committee for Quality Assurance Process Specifications amozie on DSK3GDR082PROD with RULES3 Foundation (PCPI®) VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00321 Clinical Care Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 Podiatric Medical Association ER23NO18.138</GPH> Preventive Care and Screening: Inflnenza Immunization: Percentage of patients aged 6 months and older seen for a visit between October 1 and March 31 who received an influenza immunization OR who reported previous receipt of an influenza immunization. Population Health v8 60156 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.15. Preventive Medicine 0421 128 CMS69v 7 Medicare Part B Claims Measure Specifications, eCQM Specifications, MIPS CQMs Specifications Process Community/ Population Health Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up Plan: Percentage of patients aged 18 years and older with a BMI documented during the current encounter or during the previous 12 months AND with a BMI outside of normal parameters, a follow-up plan is documented during the encounter or during the previous 12 months of the current encounter. Normal Parameters: Age 18 years and older BMI => 18.5 and< 25 Centers for Medicare& Medicaid Services 0419 130 CMS68v 8 Medicare Part BClaims Measure Specifications, eCQM Specifications, MIPS CQMs Specifications Process Patient Safety Centers for Medicare& Medicaid Services 0418 134 CMS2v8 Medicare Part B Claims Measure Specifications, eCQM Specifications, CMS Web Interface Measure Specifications, MIPS CQMs Process Community/ Population Health Documentation of Current Medications iu the Medical Record: Percentage of visits for patients aged 18 years and older for which the eligible professional or eligible clinician attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list must include ALL known prescriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutritional) supplements AND must contain the medications' name, dosage, frequency and route of administration. Preventive Care and Screening: Screening for Clinical Depression and Follow-Up Plan: Percentage of patients aged 12 years and older screened for clinical depression on the date of the encounter using an age appropriate standardized depression screening tool AND if positive, a follow-up plan is documented on the date of the positive screen. ! (Patient Safety) 0101 154 N/A Medicare Part B Claims Measure Specifications, MIPS CQMs Process Patient Safety Falls: Risk Assessment: Percentage of patients aged 65 years and older with a history of falls who had a risk assessment for falls completed within 12 months. National Committee for Quality Assurance ! (Care Coordination) 0101 155 N/A Process Communication and Care Coordination Falls: Plan of Care: Percentage of patients aged 65 years and older with a history of falls who had a plan of care for falls documented within 12 months. National Committee for Quality Assurance (Patient Safety) amozie on DSK3GDR082PROD with RULES3 § VerDate Sep<11>2014 v7 19:26 Nov 21, 2018 Jkt 247001 Part B Claims Measure Specifications, eCQM Specifications, CMSWeb Interface Measure Specifications, MIPS CQMs Specifications PO 00000 Process Frm 00322 Population Health Fmt 4701 Sfmt 4725 Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: a. Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months. b. Percentage of patients aged 18 years and older who were screened for tobacco use and identified as a tobacco user who received tobacco cessation intervention. c. Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation intervention if E:\FR\FM\23NOR3.SGM 23NOR3 Centers for Medicare& Medicaid Services Consortium for Performance Foundation (PCPI®) ER23NO18.139</GPH> * § Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60157 B.15. Preventive Medicine N/A 374 7 B Claims Measure Specifications, eCQM Specifications, MIPS CQMs Specifications CMS50v 7 eCQM Specifications, MIPS CQMs Specifications (Care Coordination) Population Health Process Communication and Care Coordination Process Population Health Specifications 2152 431 NA MlPSCQMs Specifications Process 438 CMS347 v2 eCQM Specifications, CMSWeb Interface Measure Specifications, MIPS CQMs Specifications Process Community/ Population Health Clinical Care N/A 474 N/A MlPSCQMs Specifications Process Community/Po pulation Health N/A 475 CMS349 vl eCQM Specifications Process Community/Po pulation Health We Preventive Care and Screening: Screening for High Blood Pressure and Follow-Up Documented: Percentage of patients aged 18 years and older seen during the reporting period who were screened for high blood pressure AND a recommended follow-up plan is documented based on the current blood pressure (BP) reading as indicated. Closing the Referral Loop: Receipt of Specialist Report: Percentage of patients with referrals, regardless of age, for which the referring provider receives a report from the provider to whom the patient was referred. Tobacco Use and Help with Quitting Among Adolescents: The percentage of adolescents 12 to 20 years of age with a primary care visit during the measurement year for whom tobacco use status was documented and received help with quitting Preventive Care and Screening: Unhealthy Alcohol Use: Screening & Brief Counseling: Percentage of patients aged 18 years and older who were screened for unhealthy alcohol use using a systematic screening method at least once within the last 24 months AND who received brief counseling if identified as an alcohol user. Statin Therapy for the Prevention and Treatment of Cardiovascular Disease: Percentage of the following patients-all considered at high risk of cardiovascular events-who were prescribed or were on statin therapy during the measurement period: • Adults aged 2: 21 years who were previously diagnosed with or currently have an active diagnosis of clinical atherosclerotic cardiovascular disease (ASCVD); OR • Adults aged 2:21 years who have ever had a fasting or direct low-density lipoprotein cholesterol (LDL-C) level;:: 190 mg/dL; OR • Adults aged 40-75 years with a diagnosis of diabetes with a fasting or direct LDL-C level of70-189 Zoster (Shingles) Vaccination: The percentage of patients 50 years of age and older who have a Varicella Zoster (shingles) vaccination. HIV Screening: Percentage of patients 15-65 years of age who have ever been tested for human Medicare& Medicaid Services Centers for Medicare& Medicaid Services Committee for Quality Assurance Physician Consortium for Performance Centers Medicare& Medicaid Services PPRNet Centers for Disease Control and Prevention measure set. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00323 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.140</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are finalizing the Preventive Medicine Specialty Measure Set as proposed for the 2019 Performance Period and future years. However, as noted in our responses to public comments in Table C, we are not finalizing the following measures for removal from this measure set: Q048. Q154, Q155. Therefore, measures Q048. Q154, Q155 are retained for the 2019 Performance Period and future years. These measures were previously included within the 2018 measure set and therefore will continue to be included in this measure set. To this we have deleted the Removal table in this final rule. 60158 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.16. Neurology In addition to the considerations discussed in the introductory language of Table Bin this final rule, the Neurology specialty set takes into consideration the following criteria, which includes, but is not limited to: the measure reflects current clinical guidelines and the coding of the measure includes the specialists. CMS may reassess the appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. This measure set does not have any measures removed from prior years. B.16. Neurology ! (Patient Safety) Measure Specifications, MIPSCQMs Specifications 0419 0418 ! (Care Coordination) 0101 130 134 155 CMS68v 8 CMS2v8 amozie on DSK3GDR082PROD with RULES3 0028 VerDate Sep<11>2014 226 19:26 Nov 21, 2018 Medicare Part BClaims Measure Specifications, eCQM Specifications, MIPSCQMs Specifications Process Medicare Part BClaims Measure Specifications, eCQM Specifications, CMS Web Interface Measure Specifications, MIPSCQMs Process Part Process N/A (Patient Safety) CMS138 v7 Jkt 247001 Coordination Process Part BClaims Measure Specifications, MIPSCQMs Specifications Process Medicare Part BClaims Process PO 00000 Frm 00324 Fmt 4701 Advance Care Plan: Percentage of patients aged 65 years and older who have an advance care plan or surrogate decision maker documented in the medical record or documentation in the medical record that an advance care plan was discussed but the patient did not wish or was not able to name a surrogate Patient Safety Percentage of visits for patients aged 18 years and older for which the eligible professional or eligible clinician attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list must include ALL known prescriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutritional) supplements AND must contain the medications' name, and route of administration. Preventive Care and Screening: Screening for Clinical Depression and Follow-Up Plan: Percentage of patients aged 12 years and older screened for clinical depression on the date of the encounter using an age appropriate standardized depression screening tool AND if positive, a follow-up plan is documented on the date of the positive screen. Community/ Population Health Quality Assurance Centers for Medicare& Medicaid Services Centers for Medicare& Medicaid Services Falls: Risk Assessment: Percentage of patients aged 65 years and older with a history of falls who had a risk assessment for falls completed within 12 months. Communication and Care Coordination Falls: Plan of Care: Percentage of patients aged 65 years and older with a history of falls who had a plan of care for falls documented within 12 months. Elder Maltreatment Screen and Follow-Up Plan: Percentage of patients aged 65 years and older with a documented elder maltreatment screen screen. Tobacco Use: Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 Medicare& Medicaid Services Physician Consortium ER23NO18.141</GPH> ! (Care Coordination) Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60159 B.16. Neurology 268 N/A Health Process Effective Clinical Care Process Effective Clinical Care B Claims Measure Specifications, MIPSCQMs Specifications 2872 281 CMS149 v7 eCQM Specifications amozie on DSK3GDR082PROD with RULES3 Specifications Clinical Care N/A 283 N/A MIPSCQMs Specifications Process Effective Clinical Care ! (Patient Safety) N/A 286 N/A MIPS CQMs Specifications Process Patient Safety ! (Care Coordination) N/A 288 N/A MIPSCQMs Specifications Process Communication and Care Coordination VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00325 Fmt 4701 Sfmt 4725 a. Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months. b. Percentage of patients aged 18 years and older who were screened for tobacco use and identified as a tobacco user who received tobacco cessation intervention. c. Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user. Epilepsy: Counseling for Women of Childbearing Potential with Epilepsy: All female patients of childbearing potential (12 44 years old) diagnosed with epilepsy who were counseled or referred for counseling for how epilepsy and its treatment may affect for Performance Dementia: Cognitive Assessment: Percentage of patients, regardless of age, with a diagnosis of dementia for whom an assessment of cognition is performed and the results reviewed at least once within a 12-month period. Physician Consortium for Performance Foundation (PCPI®) Dementia: Functional Status Assessment: Percentage of patients with dementia for whom an assessment of functional status was performed at least once in the last 12 months. Dementia: Associated Behavioral and Psychiatric Symptoms Screening and Management: Percentage of patients with dementia for whom there was a documented symptoms screening for behavioral and psychiatric symptoms, including depression, AND for whom, if symptoms screening was positive, there was also documentation of recommendations for symptoms management in the last 12 months. Dementia: Safety Concern Screening and Follow-Up for Patients with Dementia: Percentage of patients with dementia or their caregiver(s) for whom there was a documented safety concerns screening in two domains of risk: (1) dangerousness to self or others; and (2) environmental risks; and if safety concerns screening was positive in the last 12 months, there was documentation of mitigation recommendations, including but not limited to referral to other resources. Dementia: Education and Support of Caregivers for Patients with Dementia: Percentage of patients, regardless of age, with a diagnosis of dementia whose caregiver(s) were provided with education on dementia disease management and health behavior changes AND referred to additional sources for support within a 12-month E:\FR\FM\23NOR3.SGM 23NOR3 American Psychiatric Association and American Academy Neurology American Psychiatric Association and American Academy Neurology American Psychiatric Association and American Academy Neurology ER23NO18.142</GPH> Measure Specifications, eCQM Specifications, CMS Web Interface Measure Specifications, MIPSCQMs Specifications 60160 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.16. Neurology 291 NIA MIPSCQMs Specifications Process Effective Clinical Care N/A 293 N!A Registry Process Communication and Care Coordination N/A 317 CMS22v 7 Medicare Part BClaims Measure Specifications, eCQM Specifications, MIPSCQMs Process Community/Pop ulation Health eCQM Specifications, MIPSCQMs Specifications Process (Care Coordination) ! 7 NIA 386 NIA MIPS CQMs Specifications Process Person and CaregiverCentered Experience and Outcomes N/A 408 NIA MIPS CQMs Specifications Process Effective Clinical Care NIA 412 NIA MIPSCQMs Specifications Process Effective Clinical Care (Opioid) ! amozie on DSK3GDR082PROD with RULES3 (Opioid) VerDate Sep<11>2014 and Care Coordination 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00326 Fmt 4701 Sfmt 4725 Centers for Medicare& Medicaid Services Opioid Therapy Follow-up Evaluation: All patients 18 and older prescribed opiates for longer than 6 weeks duration who had a followup evaluation conducted at least every 3 months during Opioid Therapy documented in the medical record. Documentation of Signed Opioid Treatment Agreement: All patients 18 and older prescribed opiates for longer than 6 weeks duration who signed an opioid treatment agreement at least once during Opioid Therapy documented in the medical record. E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.143</GPH> N/A Parkinson's Disease: Psychiatric Symptoms Assessment for Patients with Parkinson's Disease: Percentage of all patients with a diagnosis of Parkinson's Disease [PD] who were assessed for 12 months. in the Parkinson's Disease: Cognitive Impairment or Dysfunction Assessment: Percentage of all patients with a diagnosis of Parkinson's Disease [PD] who were assessed for cognitive impairment or dysfunction in the past 12 Parkinson's Disease: Rehabilitative Therapy Options: All patients with a diagnosis of Parkinson's disease (or caregiver(s ), as appropriate) who had rehabilitative therapy options (for example, physical, occupational, or speech therapy) discussed in the last 12 months. Preventive Care and Screening: Screening for High Blood Pressure and Follow-Up Documented: Percentage of patients aged 18 years and older seen during the reporting period who were screened for high blood pressure AND a recommended follow-up plan is documented based on the current blood Closing the Referral Loop: Receipt of Specialist Report: Percentage of patients with referrals, regardless of age, for which the referring provider receives a report from the provider to whom the patient was referred. Amyotrophic Lateral Sclerosis (ALS) Patient Care Preferences: Percentage of patients diagnosed with Amyotrophic Lateral Sclerosis (ALS) who were offered assistance in planning for end oflife issues (for example, advance directives, invasive at least once Tobacco Use and Help Adolescents: The percentage of adolescents 12 to 20 years of age with a primary care visit during the measurement year for whom tobacco use status was documented and received help with quitting 60161 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.16. Neurology ! (Opioid) ! (Efficiency) Evaluation or Interview for Risk ofOpioid Misuse: All patients 18 and older prescribed opiates for longer than 6 weeks duration evaluated for risk of opioid misuse using a brief validated instrument (for example, Opioid Risk Tool, SOAPP-R) or patient interview documented at least once during in the medical record. N/A 419 N/A Medicare Part BClaims Measure Specifications, MIPSCQMs Process Efficiency and Cost Reduction 2152 431 N/A MIPSCQMs Specifications Process Population/ Community N/A 435 N/A Medicare Part BClaims Measure Specifications, MIPSCQMs Specifications Patient Reporte d Outcom e Effective Clinical Care • ! (Outcome) Preventive Care and Screening: Unhealthy Alcohol Use: Screening & Brief Counseling: Percentage of patients aged 18 years and older who were screened for unhealthy alcohol use using a systematic screening method at least once within the last 24 months AND who received brief counseling if identified as an unhealthy alcohol user. Quality Of Life Assessment For Patients With Primary Headache Disorders: Percentage of patients with a diagnosis of primary headache disorder whose health related quality oflife (HRQoL) was assessed with a tool(s) during at least two visits during the 12month measurement period AND whose health related quality oflife score stayed the same or Physician Consortium for Performance Comment: One commenter Q134: Care Comorbid depression is a frequent concern for patients with neurologic conditions. Response: We thank the commenter for their support of measure Q134: Preventive Care and Screening: Screening for Clinical Depression and Follow-up Plan. Comment: Two commenters do not support removal ofQ386: Amyotrophic Lateral Sclerosis (ALS) Patient Care Preferences from this measure set. The commenters appreciated the effort to decrease redundancy between this measure and the Q04 7 Advance Care Plan measure. While these measures do overlap, the commenters noted that ALS measure specification recognizes the likely earlier age of onset of this devastating diagnosis and the need to have earlier planning conversations around palliative and end oflife care by having no minimum age requirement. For this reason, the commenter believed the measure should be retained. Response: We agree with the commenters concerns about removing measure Q386 and will not finalize this measure for removal. Specifically, we agree that patients with ALS are often younger than those in the denominator for measure Q047, which includes patients age 65 and older. For this reason, we concur with commenters that a separate measure applying to all patients with a diagnosis of ALS is clinically indicated. Comment: One commenter requested that CMS consider adding the measure Q370: Depression Remission at Twelve Months to this measure set because they stated that comorbid depression is a frequent concern for patients with neurologic conditions. Response: We note that this measure set does include Q 134, which screens for depression and would address the commenter's concern of identifying co morbid depression. Prior to rulemaking, we solicit feedback from stakeholders with regards to measures that should be added or removed to existing specialty sets or the development of new specialty sets. The suggestion to add the measure to the Neurology specialty measure set was not provided as part ofthe feedback received from specialty stakeholders for the 2019 performance period. We ask the commenter to submit their feedback during this solicitation process for future consideration in rulemaking. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00327 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.144</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are fmalizing the Neurology Specialty Measure Set as proposed for the 2019 Performance Period and future years with the exception of the newly proposed composite measure: Falls: Screening, Risk-Assessment, and Plan of Care to Prevent Future Falls. We are no longer finalizing the inclusion of the composite falls measure because it must be fully vetted to utilize standardized tools that would appropriately identify the at-risk patient population. In addition, as noted in our responses to public comments in Table C, measures Q154, Q155, and Q386 are not finalized for removal from this measure set as proposed; therefore, they will be retained in this measure set for the 2019 Performance Period and future 60162 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.17. Mental/Behavioral Health In addition to the considerations discussed in the introductory language of Table Bin this final rule, the Mental/Behavioral Health specialty set takes into consideration the following criteria, which includes, but is not limited to: the measure reflects current clinical guidelines and the coding of the measure includes the specialists. CMS may reassess the appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. In addition, as outlined at the end of this table, we removed the following quality measure from the specialty set: Quality ID: 367. B.17. Mental/Behavioral Health Community /Population Health Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up Plan: Percentage of patients aged 18 years and older with a BMI documented during the current encounter or during the previous 12 months AND with a BMI outside of normal parameters, a follow-up plan is documented during the encounter or during the previous 12 months of the current encounter. Normal Parameters: 18 years and older BMI => 18.5 and < 25 Centers for Medicare & Medicaid Services Patient Safety Documentation of Current Medications in the Medical Record: Percentage of visits for patients aged 18 years and older for which the eligible professional or eligible clinician attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list must include ALL known prescriptions, over-thecounters, herbals, and vitamin/mineral/dietary (nutritional) supplements AND must contain the medications' name, dosage, frequency and route of administration. Preventive Care and Screening: Screening for Clinical Depression and Follow-Up Plan: Percentage of patients aged 12 years and older screened for clinical depression on the date of the encounter using an age appropriate standardized depression screening tool AND if positive, a follow-up plan is documented on the date of the positive screen. Centers for Medicare & Medicaid Services eCQM Specifications Process Effective Clinical Care 0421 128 CMS69v 7 Medicare Part B Claims Measure Specifications, eCQM Specifications, MIPS CQMs Specifications Process 0419 130 CMS68v 8 Medicare Part B Claims Measure Specifications, eCQM Specifications, MIPS CQMs Specifications Process 0418 134 CMS2v8 Part BClaims Measure Specifications, eCQM Specifications, CMSWeb Interface Measure Specifications, MIPS Process Jkt 247001 PO 00000 Frm 00328 I Population Health Fmt 4701 Committee for Quality Assurance Physician Consortium for Performance Improvement CMS161 v7 19:26 Nov 21, 2018 Anti-Depressant Medication Management: Percentage of patients 18 years of age and older who were treated with antidepressant medication, had a diagnosis of major depression, and who remained on antidepressant medication treatment. Two rates are reported: a. Percentage of patients who remained on an antidepressant medication for at least 84 days (12 weeks). b. Percentage of patients who remained on an antidepressant medication for at least 180 days Adult Major Depressive Disorder (MDD): Suicide Risk Assessment: Percentage of patients aged 18 years and older with a diagnosis of major depressive disorder (MDD) with a suicide risk assessment completed during the visit in which a 107 (Patient Safety) amozie on DSK3GDR082PROD with RULES3 Clinical Care 0104 § VerDate Sep<11>2014 Specifications Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 Centers Medicare& Medicaid Services ER23NO18.145</GPH> * v7 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60163 B.17. Mental/Behavioral Health ! (Patient Safety) § ! (Patient Safety) 0028 Process 226 v7 BClaims Measure Specifications, eCQM Specifications, CMSWeb Interface Measure Specifications, MIPS CQMs Specifications I Population Health Elder Maltreatment Screen and Follow-Up Plan: Percentage of patients aged 65 years and older with a documented elder mal-treatment screen using an Elder Maltreatment Screening Tool on the date of encounter AND a documented follow-up on the date of the screen. Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: a. Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months. b. Percentage of patients aged 18 years and older who were screened for tobacco use and identified as a tobacco user who received tobacco cessation intervention. c. Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user. Dementia: Cognitive Assessment: Percentage of patients, regardless of age, with a diagnosis of dementia for whom an assessment of cognition is performed and the results reviewed at least once within a 12-month period. Consortium for Performance Improvement Foundation (PCPI®) 2872 281 CMS149 v7 eCQM Specifications Process Effective Clinical Care N/A 282 N/A MIPSCQMs Specifications Process Effective Clinical Care Dementia: Functional Status Assessment: Percentage of patients with dementia for whom an assessment of functional status was performed at least once in the last 12 months. American Psychiatric Association American Academy of N/A 283 N/A MIPSCQMs Specifications Process Effective Clinical Care Dementia: Associated Behavioral and Psychiatric Symptoms Screening and Management: Percentage of patients with dementia for whom there was a documented symptoms screening for behavioral and psychiatric symptoms, including depression, AND for whom, if symptoms screening was positive, there was also documentation of recommendations for symptoms American Psychiatric Association American Academy of Neurology N/A 286 N/A MIPSCQMs Specifications Process Patient Safety Dementia: Safety Concern Screening and Follow-Up for Patients with Dementia: Percentage of patients with dementia or their caregiver(s) for whom there was a documented safety concerns screening in two domains of risk: (1) dangerousness to self or others; and (2) environmental risks; and if safety concerns screening was positive in the last 12 months, there was documentation of mitigation recommendations, including but not limited to referral to other resources. Dementia: Education and Support of Caregivers for Patients with Dementia: Percentage of patients with dementia whose caregiver(s) were provided with education on dementia disease management and health behavior changes AND were referred to additional resources for in the last 12 months. American Psychiatric Association American Academy of Neurology Process ation and Care Coordinatio n Physician Consortium for Performance Improvement Foundation VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00329 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.146</GPH> amozie on DSK3GDR082PROD with RULES3 Process 60164 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.17. Mental/Behavioral Health ! (Care Coordination) N/A 325 N/A MIPSCQMs Specifications v8 Specifications Population Health Process Communic ation/ Care Coordinatio n Process amozie on DSK3GDR082PROD with RULES3 American Psychiatric Association Committee for Quality Assurance 370 CMS159 v7 eCQM Specifications, CMSWeb Interface Measure Specifications, MIPS CQMs Outcome Effective Clinical Care 0712 371 CMS160 v7 eCQM Specifications Process Effective Clinical Care Depression Utilization of the PHQ-9 Tool: The percentage of adolescent patients (12 to 17 years of age) and adult patients (18 years of age or older) with a diagnosis of major depression or dysthymia who have a completed PHQ-9 or PHQ- MN Community Measurement N/A 374 CMS50v 7 eCQM Specifications, MIPS CQMs Specifications Process Communica tion and Care Coordinatio n Centers for Medicare & Medicaid Services 1365 382 CMS177 v7 eCQM Specifications Process Patient Safety Closing the Referral Loop: Receipt of Specialist Report: Percentage of patients with referrals, regardless of age, for which the referring provider receives a report from the provider to whom the patient was referred. Child and Adolescent Major Depressive Disorder (MDD): Suicide Risk Assessment: Percentage of patient visits for those patients aged 6 through 17 years with a diagnosis of major depressive disorder with an assessment for suicide risk. (Care Coordination) VerDate Sep<11>2014 Medicaid Services 0710 ! (Outcome) ! (Patient Safety) Clinical Care Documented: Percentage of patients aged 18 years and older seen during the reporting period who were screened for high blood pressure AND a recommended follow-up plan is documented based on the current blood pressure (BP) reading as indicated. Adult Major Depressive Disorder (MDD): Coordination of Care of Patients with Specific Comorbid Conditions: Percentage of medical records of patients aged 18 years and older with a diagnosis of major depressive disorder (MOD) and a specific diagnosed comorbid condition (diabetes, coronary artery disease, ischemic stroke, intracranial hemorrhage, chronic kidney disease [stages 4 or 5], End Stage Renal Disease [ESRD] or congestive heart failure) being treated by another clinician with communication to the clinician treating the comorbid condition. Follow-Up Care for Children Prescribed ADHD Medication (ADD): Percentage of children 6-12 years of age and newly dispensed a medication for attentiondeficit/hyperactivity disorder (ADHD) who had appropriate follow-up care. Two rates are reported. a. Percentage of children who had one follow-up visit with a practitioner with prescribing authority during the 30-Day Initiation Phase. b. Percentage of children who remained on ADHD medication for at least 210 days and who, in addition to the visit in the Initiation Phase, had at least two additional follow-up visits with a practitioner within 270 days (9 months) after the Initiation Phase Depression Remission at Twelve Months: The percentage of adolescent patients 12 to 17 years of age and adult patients18 years of age or older with major depression or dysthymia who reached remission 12 months (+I- 60 days) after an index event date. 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00330 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 Minnesota Community Measurement Physician Consortium for Performance Improvement Foundation (PCPI®) ER23NO18.147</GPH> Measure Specifications, eCQM Specifications, MIPS CQMs Specifications Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60165 B.17. Mental/Behavioral Health ! 1879 383 NIA MIPSCQMs Specifications Intermedi ate Outcome 0576 391 NIA MIPSCQMs Specifications Process (Outcome) ! (Care Coordination) Patient Safety Communic ation/ Care Coordinatio n NIA 402 NA MIPSCQMs Specifications Adherence to Antipsychotic Medications for Individuals with Schizophrenia: Percentage of individuals at least 18 years of age as of the beginning of the measurement period with schizophrenia or schizoaffective disorder who had at least two prescriptions filled for any antipsychotic medication and who had a Proportion of Days Covered (PDC) of at least 0.8 for antipsychotic medications during the National Committee for Quality Assurance Follow-up After Hospitalization for Mental Illness (FUH): The percentage of discharges for patients 6 years of age and older who were hospitalized for treatment selected mental illness diagnoses and who had a follow-up visit with a mental health practitioner. Two rates are submitted: • The percentage of discharges for which the patient received follow-up within 30 days of discharge. • The percentage of discharges for which the patient received follow-up within 7 days of National Committee for Quality Assurance Community I Population Health Tobacco Use and Help with Quitting Among National Adolescents: Committee for The percentage of adolescents 12 to 20 years of Quality age with a primary care visit during the Assurance measurement year for whom tobacco use status was documented and received help with quitting if identified as a tobacco user. MIPSCQMs 0711 411 NIA Outcome Depression Remission at Six Months: MN Effective The percentage of adolescent patients 12 to 17 years Community ! Specifications Clinical of age and adult patients 18 years of age or older Measurement (Outcome) Care with major depression or dysthymia who reached remission 6 months (+I- 60 days) after an index event date. Physician 2152 431 NIA MIPSCQMs Process Community Preventive Care and Screening: Unhealthy Specifications I Alcohol Use: Screening & Brief Counseling: Consortium for Percentage of patients aged 18 years and older who Performance Population Improvement Health were screened for unhealthy alcohol use using a systematic screening method at least once within the Foundation last 24 months AND who received brief counseling (PCPI®) alcohol University of ! NIA 468 NIA MIPSCQMs Process Effective Continuity of Pharmacotherapy for Opioid Use (Opioid) Specifications Clinical Disorder: Percentage of adults aged 18 years and Southern older with pharmacotherapy for opioid use disorder California Care (OUD) who have at least 180 days of continuous treatment. Comment: One commenter stated that the Mental/Behavioral Health Specialty Measure Set too narrowly defines the measures' denominator populations. This type of highly detailed specification inappropriately limits the users' abilities to apply otherwise applicable and useful measures to a larger percentage of patients. The commenter also stated that considering the frequency of medical co morbidity diagnoses and the fragmented health care delivery for serious mental illness (SMI) patients, it requested that CMS include more cross-cutting measures that address commonly diagnosed medical comorbidities among patients with SMI into the Mental/Behavioral Health Specialty Measure Set. Due to the nature ofthe encounter, the eligible clinician-psychiatrist might not utilize otherwise appropriate measures because it might be therapeutically inappropriate. The decision to employ a quality measure for all specialties must be made on a case-by-case basis. Process VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00331 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.148</GPH> amozie on DSK3GDR082PROD with RULES3 Response: Prior to rulemaking, we solicit feedback from stakeholders with regards to measures that should be added or removed to existing specialty sets or the development of new specialty sets. We ask the commenter to submit their feedback during this solicitation process for future consideration in rulemaking. In addition, eligible clinicians are not limited to selecting measures from their specialty measure set, but have the opportunity to select any of the MIPS measure that are applicable to their practice and workflow. We encourage the commenter to collaborate with measure developers to create robust measures that address patient with serious mental illnesses with comorbidities. Once fully tested, we request the measure be submitted to the Call for Measures process for consideration. 60166 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.17. Mental/Behavioral Health attention that has been focused on other specialties. The commenter requested that CMS provide background on tbe development of its measures for these behavioral health clinicians and solicit input from tbese clinicians as to tbe appropriateness of tbose measures. Response: The measures included within the measure specialty set have been reviewed and developed by specialty societies. Prior to rulemaking, we solicit feedback from stakeholders with regards to measures that should be added or removed to existing specialty sets or the development of new specialty sets. We ask tbe commenter to submit their feedback during this solicitation process for future consideration in rulemaking. Each of the measures included in tbe specialty measure sets is developed and stewarded by various measure stewards as indicated in the table. The measure steward revises the quality measure during tbe annual revision cycle based on their technical expert panel input and direction. Comment: One commenter did not agree that new measures must be developed to specifically address patients with mental or substance use disorders and medical co morbidities. Measures that already exist for tbe general population would be adequate to use to monitor tbese conditions. Response: We disagree and believe tbere is a gap in measurement tbat addresses mental and substance use disorders. Measures applicable to the general population are not appropriate to promote appropriate or adherence of treatment for patient witb mental and substance use disorders witb comorbidities. Comment: One commenter requested tbat CMS test tbe measure Ql05: Anti-Depressant Medication Management at tbe clinician-level before its continued use in MIPS. Response: This measure has been in use at tbe clinician-level for several years without incident so we believe tbat its continued use in MIPS is appropriate until clinicianlevel testing is conducted by the steward. We will continue to encourage the steward to expand testing for tbis measure at tbe clinician-level. Comment: One commenter was concerned about tbe denominator for measure Q107: Adult Major Depressive Disorder (MDD): Suicide Risk Assessment. As currently specified, tbe denominator limits screening for suicide to patients witb new onset or recurrent episodes of Major Depressive Disorder (MDD), instead of applying it to patients with mood disorders, as supported by the measure's rationale and evidence to measure (part oftbe National Quality Forum's 2018 Spring Behavioral Health Measure Endorsement Cycle). Current evidence supports suicide risk assessments for an even broader population, like patients with other mental illnesses who present an increased safety risk. This measure would be better specified by including patients with comorbid-multiple psychiatric illnesses paired with increased substance use and medical conditions (that is, chronic pain). The commenter requested that CMS work with the measure's developers to also provide a definition oftbe term "assessment to avoid issues witb tbe measure's reliability and to provide clarity to those clinicians who do not possess expertise in suicide risk assessments. In addition, tbe commenter recommended that measure Q 107 include references on the use of validated rating scales designed for suicide screening and assessment. Response: This measure was originally developed as part of a suite of measures to improve care for adults witb major depressive disorder and was specified and tested for that population. We will give consideration to this suggestion in future updates of tbe measure. A change in the measure intent as suggested would require additional testing to understand the impact on measure performance, feasibility, reliability, and validity of the measure. A "suicide risk assessment" is defmed more explicitly in tbe Numerator Details section in the human readable format of this measure's technical specifications. The clinical guideline statement also makes reference to key components of a complete assessment. Clinical guidance on how to address and manage patients who screen positive for suicidal ideation is provided in the human readable format of this measure's technical specifications. Use of a standardized tool or instrument to assess suicide risk will meet numerator performance, and can be mapped to a general SNOMED CT code: "Suicide risk assessment (procedure)". We encourage mapping to tbis concept in order to ensure tbat tbe suicide risk assessment was performed. We will work witb the measure steward to consider reference to specific suicide risk assessment tools for clinician guidance in future updates of this measure. Comment: One commenter stated that measure Ql05: Anti-Depressant Medication Management consists of a limited denominator. Antidepressants may be prescribed to individuals who do not meet criteria for an MDD diagnosis. According to current evidence, various mental illnesses may be treated with antidepressants; as such, adherence to antidepressants result in more positive healtb outcomes for tbose for whom tbey are appropriately prescribed. Therefore, the commenter requested that CMS engage witb tbe measure's developers and discuss widening tbe measure's population to consist of anyone prescribed antidepressants as guided by current evidence. Thus, this measure should not be considered for use in the MIPS quality performance category until it is tested and demonstrates valid and reliable measurement characteristics. Response: This measure is focused on treating patients with major depression disorder. Expanding tbe denominator to include all patients taking antidepressants would change the intent oftbis measure. We will give consideration to this suggestion in future updates oftbe measure. A change in the measure intent as suggested would require additional testing to understand the impact on measure performance, feasibility, reliability, and validity of the measure. Comment: One commenter appreciated that measure Q325: Adult Major Depressive Disorder (MDD): Coordination of Care of Patients with Specific Comorbid Conditions remains in tbis measure set. The commenter interpreted tbe lack of tbe "Individual Measures List" proposed within the rule to mean tbat CMS solely supports quality measures as part of specialty measure sets, and the commenter concluded tbat clinicians would be required to select measures from one oftbe 33 specialty sets to meet the 6-measure (including one outcome or high priority measure) criteria. Response: We thank tbe commenter for tbeir support of measure Q325: Adult Major Depressive Disorder (MDD): Coordination of Care of Patients witb Specific Comorbid Conditions. Previously finalized measure sets were not republished in the proposed rule and remain available for applicable specialties. VerDate Sep<11>2014 19:26 Nov 21, 2018 the Mental/Behavioral Health Jkt 247001 PO 00000 Frm 00332 for the 2019 Performance Period and future Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.149</GPH> amozie on DSK3GDR082PROD with RULES3 FINALACTION: Weare Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60167 B.17. Mental/Behavioral Health This measure is being removed from the 2019 program based on the detailed rationale described below for this measure in "Table C: Quality Measures Finalized for Removal in the 2021 MIPS Payment Year and Future Years." Comment: One commenter did not support removal of measure Q367: Bipolar Disorder and Major Depression: Appraisal for alcohol or chemical substance use. The commenter stated that removal would make this measure set lack measures that address unhealthy substance use. The commenter did not agree that measure Q431: Preventive Care and Screening: Unhealthy Alcohol Use: Screening & Brief Counseling is duplicative or superior to measure Q367. If the developers were to update the denominator to include the general population and the numerator to include data capture of the follow-up actions related to the appraisal, this measure would be more useful in MIPS than is measure Q431. N/A 367 CMS169 v7 eCQM Specificatio ns Process Effective Clinical Care Bipolar Disorder and Major Depression: Appraisal for alcohol or chemical substance use: Percentage of patients with depression or bipolar disorder with evidence of an initial assessment that includes an appraisal for alcohol or chemical substance use. Center for Quality Assessment and Improvemen tin Mental Health Response: Currently, Q367 does not include follow-up actions when there is identified alcohol or substance abuse. The measure steward has not currently specified this for Q367 and although they could add it in the future, it would not be in enough time to implement for the 2019 performance period. Q431 is currently more robust as it includes the requirement of a follow-up action in identified alcohol or substance abuse patients. We agree with the commenter that a measure with a broader denominator to include the general population and the numerator to include data capture of the follow-up actions related to the appraisal would be appropriate. These revisions would require a new measure to be submitted to the Call for Measures process. We encourage the commenter to collaborate with measure developers to create a measure as suggested. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00333 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.150</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are finalizing the removal of measures from the Mental/Behavioral Health Specialty Measure Set as proposed for the 2019 Period 60168 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B. IS. Diagnostic Radiology In addition to the considerations discussed in the introductory language of Table Bin this fmal rule, the Diagnostic Radiology specialty set takes into consideration the following criteria, which includes, but is not limited to: the measure reflects current clinical guidelines and the coding of the measure includes the specialists. We may reassess the appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. In addition, as outlined at the end of this table, we removed the following quality measures from the specialty set: Quality IDs: 359 and 363. B.18. Diagnostic Radiology N/A ! (Efficiency) 0508 146 ! (Care Coordination) N/A 0507 145 N/A Medicare Part BClaims Measure Specifications, MIPSCQMs Specifications Process N/A Medicare Part BClaims Measure Specifications, MIPSCQMs Process Efficiency and Cost Reduction 147 N/A Medicare Part BClaims Measure Specifications, MIPSCQMs Specifications Process Communicati on and Care Coordination Nuclear Medicine: Correlation with Existing Imaging Studies for All Patients Undergoing Bone Scintigraphy: Percentage of final reports for all patients, regardless of age, undergoing bone scintigraphy tbat include physician documentation of correlation with existing relevant imaging studies (for example, x-ray, MRI, Society of Nuclear Medicine and Molecular Imaging 195 N/A Medicare Part BClaims Measure Specifications, MIPSCQMs Specifications Process Effective Clinical Care Radiology: Stenosis Measurement in Carotid Imaging Reports: Percentage of final reports for carotid imaging studies (neck magnetic resonance angiography [MRA], neck computed tomography angiography [CTA], neck duplex ultrasound, carotid angiogram) performed that include direct or indirect reference to measurements of distal internal carotid diameter as the denominator for stenosis measurement. Radiology: Reminder System for Screening Mammograms: Percentage of patients undergoing a screening mammogram whose information is entered into a reminder system with a target due date for tbe next American College of Radiology Patient Safety Communicati on and Care Coordination ! (Patient Safety) amozie on DSK3GDR082PROD with RULES3 ! (Patient Safety) VerDate Sep<11>2014 361 19:26 Nov 21, 2018 N/A Jkt 247001 MIPSCQMs Specifications PO 00000 Structure Frm 00334 Patient Safety Fmt 4701 Sfmt 4725 American College of Radiology American College of Radiology Optimizing Patient Exposure to Ionizing Radiation: Connt of Potential High Dose Radiation Imaging Studies: Computed Tomography (CT) and Cardiac Nuclear Medicine Studies: Percentage of computed tomography (CT) and cardiac nuclear medicine (myocardial perfusion studies) imaging reports for all patients, regardless of age, tbat document a count of known previous CT (any type ofCT) and cardiac nuclear medicine (myocardial perfusion) studies that the patient has received in the 12-month period prior to tbe current Specifications N/A Radiology: Exposure Dose Indices or Exposure Time and Number oflmages Reported for Procedures Using Fluoroscopy: Final reports for procedures using fluoroscopy tbat document radiation exposure indices, or exposure images (if radiation time and number of Optimizing Patient Exposure to Ionizing Radiation: Reporting to a Radiation Dose Index Registry: Percentage of total computed tomography (CT) studies for all E:\FR\FM\23NOR3.SGM 23NOR3 College of Radiology College of Radiology American College of Radiology ER23NO18.151</GPH> ! (Patient Safety) Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60169 B. IS. Diagnostic Radiology 362 N/A MIPSCQMs Specifications Structure Communicati on and Care Coordination * N/A 364 N/A MIPSCQMs Specifications Process Communicati on and Care Coordination ! (Appropriate Use) N/A 405 N/A Medicare Part BClaims Measure Specifications, MIPSCQMs Specifications Process Effective Clinical Care ! (Appropriate Use) N/A 406 N/A Medicare Part BClaims Measure Specifications, MIPSCQMs Specifications Process Effective Clinical Care ! (Appropriate Use) amozie on DSK3GDR082PROD with RULES3 BClaims Measure Specifications, MIPSCQMs Specifications VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00335 Clinical Care Fmt 4701 Sfmt 4725 American College of Radiology Optimizing Patient Exposure to Ionizing Radiation: Appropriateness: Follow-up CT Imaging for Incidentally Detected Pulmonary Nodules According to Recommended Guidelines: Percentage of final reports for CT imaging studies with a finding of an incidental pulmonary nodule for patients aged 35 years and older that contain an impression or conclusion that includes a recommended interval and modality for follow-up (for example, type of imaging or biopsy) or for no follow-up, and source of recommendations (for example, guidelines such as Fleischner Society, American Lung Association, American College of Chest Appropriate Follow-up Imaging for Incidental Abdominal Lesions: Percentage of final reports for abdominal imaging studies for asymptomatic patients aged 18 years and older with one or more of the following noted incidentally with follow-up imaging recommended: • Liver lesion::; 0.5 em. • Cystic kidney lesion< 1.0 em. American College of Radiology Appropriate Follow-Up Imaging for Incidental Thyroid Nodules in Patients: Percentage of final reports for computed tomography (CT), magnetic resonance imaging (MRI) or magnetic resonance angiogram (MRA) studies of the chest or neck or ultrasound of the neck for patients aged 18 years and older with no known thyroid disease with a thyroid nodule< 1.0 em noted incidentally with recommended. Radiation Consideration for Adult CT: Utilization of Dose Lowering Techniques: Percentage of final reports for patients aged 18 years and older undergoing CT with documentation that one or more of the following dose reduction techniques were used: • Automated exposure control. • Adjustment of the rnA and/or kV according to patient size. • Use of iterative reconstruction technique. American College of Radiology E:\FR\FM\23NOR3.SGM 23NOR3 American College of Radiology College of Radiology/ American Medical AssociationPhysician Consortium for Performance Improvement! National Committee for Quality Assurance ER23NO18.152</GPH> N/A that are reported to a radiation dose index registry that is capable of collecting at a minimum selected data elements. Optimizing Patient Exposure to Ionizing Radiation: Computed Tomography (CT) Images Available for Patient Follow-up and Comparison Purposes: Percentage of final reports for computed tomography (CT) studies performed for all patients, regardless of age, which document that Digital Imaging and Communications in Medicine (DICOM) format image data are available to non-affiliated external healthcare facilities or entities on a secure, media free, reciprocally searchable basis with patient authorization for at least a 12-month period after the 60170 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.18. Diagnostic Radiology Comment: One commenter noted on measure Q436: Radiation Consideration for Adult CT: Utilization of Dose Lowering Techniques that there is equivalency of a sitebased attestation and an attestation included in the individual radiology report. In practice, these generic attestations included in the report are not dictated case-by-case, but rather automatically added to all CT templates in order to satisfy the measure. Adding additional generic comments necessarily lengthens our reports, making it less likely that the requesting clinician will read the entire report or identify the clinically relevant information. The commenter suggested the following: Site-based attestations be sufficient to meet measure Q436, without requiring documentation in each individual adult CT report. Response: This measure does not require detailed comments that would lengthen a report, but requires general attestation statement in the final report; however, there would need to be a written policy in place describing the process that ensures dose optimization techniques are used appropriately per instrument/room, as well as a method for validating that their use occurs for each patient. This may include periodic audits. VerDate Sep<11>2014 19:26 Nov 21, 2018 for the 2019 Performance Period and future Jkt 247001 PO 00000 Frm 00336 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.153</GPH> amozie on DSK3GDR082PROD with RULES3 FINALACTION: Weare Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60171 B.18. Diagnostic Radiology (continued) N/A 359 NIA MIPS CQMs Specifications Process Communicat ion and Care Coordination Optimizing Patient Exposure to Ionizing Radiation: Utilization of a Standardized Nomenclature for Computed Tomography (CT) Imaging: Percentage of computed tomography (CT) imaging reports for all patients, regardless of age, with the imaging study named according to a standardized nomenclature and the standardized nomenclature is used in institution's American College of Radiology N/A 363 N/A MIPSCQMs Specifications Structure Communicat ion and Care Coordination Optimizing Patient Exposnre to Ionizing Radiation: Search for Prior Compnted Tomography (CT) Stndies Throngh a Secnre, Anthorized, Media-Free, Shared Archive: Percentage of final reports of computed tomography (CT) studies performed for all patients, regardless of age, which document that a search for Digital Imaging and Communications in Medicine (DICOM) format images was conducted for prior patient CT imaging studies completed at nonaffiliated external healthcare facilities or entities within the past 12-months and are available through a secure, authorized, media free, shared archive prior to an imaging American College of Radiology This measure is being removed from the 2019 program based on the detailed rationale described below for this measure in "Table C: Quality Measures Finalized for Removal in the 2021 MIPS Payment Year and Future Years." for this measure in C: Quality Measures for Removal in the 1 MIPS Payment Year Future Years." Comment: One commenter not support Q359: Exposure to for Computed Tomography (CT) Imaging. The commenter also did not support the removal of measure Q363: Optimizing Patient Exposure to Ionizing Radiation: Search for Prior Computed Tomography (CT) Studies Through a Secure, Authorized, Media-Free, Shared Archive. The commenter indicated that the number of radiology measures is limited, and that additional measures should be added before additional measures are removed, and CMS should also encourage clinicians to take greater advantage of existing studies as a means of reducing unnecessary duplicative exams. Response: We encourage measure developers to submit additional radiology measures through the Call for Measures process. In the event an eligible clinician reports on less than 6 quality measures, because no other measures in the set are available or applicable to their scope of practice, the quality performance category score will be adjusted accordingly through the measure validation process. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00337 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.154</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are finalizing the removal of measures from the Diagnostic Radiology Specialty Measure Set as proposed for the 2019 Performance Period and future 60172 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.19. Nephrology In addition to the considerations discussed in the introductory language of Table Bin this fmal rule, the Nephrology specialty set takes into consideration the following criteria, which includes, but is not limited to: the measure reflects current clinical guidelines and the coding of the measure includes the specialists. We may reassess the appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. In addition, as outlined at the end of this table, we removed the following quality measures from the specialty set: Quality IDs: 122 and 327. B.19. Nephrology 0059 001 CMS122 v7 Medicare Part BClaims Measure Specifications, CMS Web Interface Measure Specifications, MIPS CQMs Specifications, eCQM Intermediate Outcome Effective Clinical Care 0097 046 NIA Medicare Part BClaims Measure Specifications, MIPS CQMs Specifications Process Communica tion and Care Coordinatio n 0326 047 Part BClaims Measure Specifications, MIPS CQMs Specifications Process Medicare Part BClaims Measure Specifications, eCQM Specifications, CMS Web Interface Measure Specifications, MIPS CQMs Process Part BClaims Measure Specifications, eCQM Specifications, MIPS Process ! (Outcome) § ! (Care Coordinat ion) * ! (Care Coordinat ion) 0041 110 CMS147 v8 amozie on DSK3GDR082PROD with RULES3 v7 VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 tion and Care Coordinatio n Frm 00338 Community I Population Health I Population Health Fmt 4701 Sfmt 4725 Diabetes: Hemoglobin Ale (HbAlc) Poor Control (>9%): Percentage of patients 18-75 years of age with diabetes who had hemoglobin Ale> 9.0 percent during the measurement period. National Committee for Quality Assurance Medication Reconciliation Post-Discharge: The percentage of discharges from any inpatient facility (for example hospital, skilled nursing facility, or rehabilitation facility) for patients 18 years of age and older seen within 30 days following discharge in the office by the physician, prescribing practitioner, registered nurse, or clinical pharmacist providing on-going care for whom the discharge medication list was reconciled with the current medication list in the outpatient medical record. This measure is submitted as three rates stratified by age group: • Submission Criteria 1: 18-64 years of age. • Submission Criteria 2: 65 years and older. • Total Rate: All and older. Advance Care Plan: Percentage of patients aged 65 years and older who have an advance care plan or surrogate decision maker documented in the medical record or documentation in the medical record that an advance care plan was discussed but the patient did not wish or was not able to name a surrogate decision maker an advance care Preventive Care and Screening: Influenza Immunization: Percentage of patients aged 6 months and older seen for a visit between October 1 and March 31 who received an influenza immunization OR who reported previous receipt of an influenza immunization. National Committee for Quality Assurance Pneumococcal Vaccination Status for Older Adults: Percentage of patients 65 years of age and older who have ever received a pneumococcal vaccine. E:\FR\FM\23NOR3.SGM 23NOR3 Committee for Quality Assurance Physician Consortium for Foundation (PCPI®) Committee for Quality Assurance ER23NO18.155</GPH> § Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60173 B.19. Nephrology ! (Patient Safety) 0419 ! (Care Coordinat ion) 2624 182 N/A Medicare Part BCiaims Measure Specifications, MIPS CQMs Specifications N/A 317 CMS22v 7 Medicare Part BCiaims Measure Specifications, eCQM Specifications, MIPS CQMs Process Community I Population Health 0101 318 CMS139 v7 eCQM Specifications, CMS Web Interface Measure Process Patient Safety 1667 328 N/A MIPS CQMs Specifications Intermediate Outcome Effective Clinical Care Pediatric Kidney Disease: ESRD Patients Receiving Dialysis: Hemoglobin Level< 10 g/dL: Percentage of calendar months within a 12-month period during which patients aged 17 years and younger with a diagnosis of End Stage Renal Disease (ESRD) receiving hemodialysis or peritoneal dialysis have a hemoglobin level< 10 Renal Physicians Association N/A 330 N/A MIPS CQMs Specifications Outcome Patient Safety Adult Kidney Disease: Catheter Use for Greater Than or Equal to 90 Days: Percentage of patients aged 18 years and older with a diagnosis of End Stage Renal Disease (ESRD) receiving maintenance hemodialysis for greater than or equal to 90 days whose mode of vascular access is a catheter. One-Time Screening for Hepatitis C Virus (HCV) for Patients at Risk: Percentage of patients aged 18 years and older with one or more of the following: a history of injection drug use, receipt of a blood transfusion prior to 1992, receiving maintenance hemodialysis, OR birthdate in the 1945-1965 who received one- Renal Physicians Association CMS68v 8 (Outcome ) Process Safety Medical Record: Percentage of visits for patients aged 18 years and older for which the eligible professional or eligible clinician attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list must include ALL known prescriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutritional) supplements AND must contain the medications' name, dosage, frequency and route of Communica tion and Care Coordinatio n Functional Outcome Assessment: Percentage of visits for patients aged 18 years and older with documentation of a current functional outcome assessment using a standardized functional outcome assessment tool on the date of encounter AND documentation of a care plan based on identified functional outcome deficiencies on the date of the identified deficiencies. Preventive Care and Screening: Screening for High Blood Pressure and Follow-Up Documented: Percentage of patients aged 18 years and older seen during the reporting period who were screened for high blood pressure AND a recommended follow-up plan is documented based on the current blood as indicated. Falls: Screening for Futnre Fall Risk: Percentage of patients 65 years of age and older who were screened for future fall risk during the measurement period. BClaims Measure Specifications, eCQM Specifications, MIPS CQMs Specifications Process Process amozie on DSK3GDR082PROD with RULES3 Specifications VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00339 Clinical Care Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 Centers Medicare& Medicaid Services Centers for Medicare& Medicaid Services Centers for Medicare& Medicaid Services National Committee for Quality Assurance ER23NO18.156</GPH> 130 60174 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.19. Nephrology ! (Patient Experienc e) N/A 474 N/A MIPS CQMs Specifications Process MIPS CQMs Specifications Process Person CaregiverCentered Experience and time screening for hepatitis C virus (HCV) infection. Adult Kidney Disease: Referral to Hospice: Percentage of patients aged 18 years and older with a diagnosis ofESRD who withdraw from hemodialysis or peritoneal dialysis who are referred to hospice care. Community /Population Zoster (Shingles) Vaccination: The percentage of patients 50 years of age and older Physicians Association PPRNet We did not receive specific comments regarding the measures included in this specialty measure set. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00340 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.157</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are finalizing the Nephrology Specialty Measure Set as proposed for the 2019 Performance Period and future years with the exception of the newly proposed composite measure: Falls: Screening, Risk-Assessment, and Plan of Care to Prevent Future Falls. We are no longer finalizing the inclusion of the composite falls measure because it must be fully vetted to utilize standardized tools that would appropriately identify the at-risk patient population. In addition, as noted in our responses to public comments in Table C, measure Q386 is not finalized for removal from this measure set as proposed; therefore, it will be retained in this measure set for the 2019 Performance Period and future Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60175 B.19. Nephrology (continued) N/A 122 N/A MIPS CQMs Specifications Intermediate Outcome Effective Clinical Care N/A 327 N/A MIPS CQMs Specifications Process Effective Clinical Care Adult Kidney Disease: Blood Pressure Management: Percentage of patient visits for those patients aged 18 years and older with a diagnosis of chronic kidney disease (CKD) (stage 3, 4, or 5, not receiving Renal Replacement Therapy [RRT]) with a blood pressure < 140/90 mmHg OR 2:: 140/90 mmHg with a documented of care. Pediatric Kidney Disease: Adequacy ofVolnme Management: Percentage of calendar months within a 12-month period during which patients aged 17 years and younger with a diagnosis of End Stage Renal Disease (ESRD) undergoing maintenance hemodialysis in an outpatient dialysis facility have an assessment of the adequacy of volume management from a Renal Physicians Association This measure is being removed from the 2019 program based on the detailed rationale described below for this measure in "Table C: Quality Measures Finalized for Removal in the 2021 MIPS Payment Year and Future Years." Renal Physicians Association This measure is being removed from the 2019 program based on the detailed rationale described below for this measure in "Table C: Quality Measures Finalized for Removal in the 2021 MIPS Payment Year and Future Years." We did not receive specific comments regarding the proposed removal of measures from this specialty measure set. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00341 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.158</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are finalizing the removal of measures from the Nephrology Specialty Measure Set as proposed for the 2019 Performance Period and future years. However, as noted in our responses to public comments in Table C, we are not finalizing the following measure proposed for removal from this measure set: 18. 60176 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.20. General Surgery In addition to the considerations discussed in the introductory language of Table Bin this final rule, the General Surgery specialty set takes into consideration the following criteria, which includes, but is not limited to: the measure reflects current clinical guidelines and the coding of the measure includes the specialists. We may reassess the appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. This measure set does not have any measures removed from prior years. B.20. General Surgery 0268 021 N/A ! (Patient Safety) amozie on DSK3GDR082PROD with RULES3 VerDate Sep<11>2014 Process Part B Claims Measure Specifications, MIPSCQMs Specifications Process Patient Safety 0097 046 N/A Medicare Part B Claims Measure Specifications, MIPS CQMs Specifications Process Communicatio nand Care Coordination 0326 047 N/A Medicare Part BC!aims Measure Specifications, MIPSCQMs Specifications Process Communicatio nand Care Coordination 0421 128 CMS69 v7 Medicare Part BC!aims Measure Specifications, eCQM Specifications, MIPSCQMs Specifications Process Community/P opulation Health ! (Care Coordinat ion) ! (Care Coordinat ion) Medicare Part BCiaims Measure Specifications, MIPSCQMs Specifications 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00342 Fmt 4701 Sfmt 4725 Perioperative Care: Selection of Prophylactic Antibiotic - First OR Second Generation Cephalosporin: Percentage of surgical patients aged 18 years and older undergoing procedures with the indications for a first OR second generation cephalosporin prophylactic antibiotic, who had an order for a first OR second generation cephalosporin for antimicrobial Perioperative Care: Venous Thromboembolism (VTE) Prophylaxis (When Indicated in ALL Patients): Percentage of surgical patients aged 18 years and older undergoing procedures for which venous thromboembolism (VTE) prophylaxis is indicated in all patients, who had an order for Low Molecular Weight Heparin (LMWH), Low-Dose Unfractionated heparin (LDUH), adjusted-dose warfarin, fondaparinux or mechanical prophylaxis to be given within 24 hours prior to incision time or within 24 hours after end time. Medication Reconciliation Post-Discharge: The percentage of discharges from any inpatient facility (for example, hospital, skilled nursing facility, or rehabilitation facility) for patients 18 years of age and older seen within 30 days following discharge in the office by the physician, prescribing practitioner, registered nurse, or clinical pharmacist providing on-going care for whom the discharge medication list was reconciled with the current medication list in the outpatient medical record. This measure is submitted as three rates stratified by age group: • Submission Criteria I: 18-64 years of age. • Submission Criteria 2: 65 years and older. • Total Rate: All and older. Advance Care Plan: Percentage of patients aged 65 years and older who have an advance care plan or surrogate decision maker documented in the medical record or documentation in the medical record that an advance care plan was discussed but the patient did not wish or was not able to name a surrogate decision maker an advance care Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up Plan: Percentage of patients aged 18 years and older with a BMI documented during the current encounter or during the previous 12 months AND with a BMI outside of normal parameters, a follow-up plan is documented during the encounter or during the previous 12 months of the current encounter. Normal Parameters: and older BMI => 18.5 and< 25 E:\FR\FM\23NOR3.SGM 23NOR3 American Society of Plastic Surgeons Society of Plastic Surgeons National Committee Quality Assurance National Committee Quality Assurance Centers for Medicare& Medicaid Services ER23NO18.159</GPH> ! (Patient Safety) Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60177 B.20. General Surgery § v8 0028 226 CMSI3 8v7 Part BClaims Measure Specifications, eCQM Specifications, CMS Web Interface Measure Specifications, MIPSCQMs Process Population Health Medical Record: Percentage of visits for patients aged 18 years and older for which the eligible professional or eligible clinician attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list must include ALL known prescriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutritional) supplements AND must contain the medications' name, dosage, and route of administration. Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: a. Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months. b. Percentage of patients aged 18 years and older who were screened for tobacco use and identified as a tobacco user who received tobacco cessation intervention. Services Consortium for Performance Improvement Foundation (PCPI®) NIA 264 NIA MIPS CQMs Specifications Process Effective Clinical Care Sentinel Lymph Node Biopsy for Invasive Breast Cancer: The percentage of clinically node negative (clinical stage TINOMO or T2NOMO) breast cancer patients before or after neoadjuvant systemic therapy, who undergo a sentinel lymph node (SLN) American Society of Breast Surgeons N/A 317 CMS22 v7 Medicare Part BClaims Measure Specifications, eCQM Specifications, MIPSCQMs Process Community/ Population Health Preventive Care and Screening: Screening for High Blood Pressure and Follow-Up Documented: Percentage of patients aged 18 years and older seen during the reporting period who were screened for high blood pressure AND a recommended follow-up plan is documented based on the current blood pressure (BP) reading as Centers for Medicare& Medicaid Services ! (Outcome ) NIA 355 N!A MIPS CQMs Specifications Outcome Patient Safety Unplanned Reoperation within the 30 Day Postoperative Period: Percentage of patients aged 18 years and older who had any unplanned reoperation within the 30-day American College of Surgeons ! (Outcome ) NIA 356 NIA MIPS CQMs Specifications Outcome Effective Clinical Care Unplanned Hospital Readmission within 30 Days of Principal Procedure: Percentage of patients aged 18 years and older who had an unplanned hospital readmission within 30 American College of Surgeons N/A 357 N/A MIPS CQMs Specifications Outcome Effective Clinical Care American College of NIA 358 NIA MIPS CQMs Specifications Process Person and CaregiverCentered Experience and Outcomes Surgical Site Infection (SSI): Percentage of patients aged 18 years and older who had a site infection Patient-Centered Surgical Risk Assessment and Communication: Percentage of patients who underwent a nonemergency surgery who had their personalized risks of postoperative complications assessed by their surgical team prior to surgery using a clinical databased, patient-specific risk calculator and who received personal discussion of those risks with the NIA 374 CMS50 v7 Process Communicatio nand Care (Outcome ! (Patient Experienc e) amozie on DSK3GDR082PROD with RULES3 BCiaims Measure Specifications, eCQM Specifications, MIPSCQMs Specifications VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00343 Fmt 4701 Sfmt 4725 American College of Surgeons Centers for Medicare& E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.160</GPH> ! (Patient Safety) 60178 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.20. General Surgery N/A 402 N/A MIPS CQMs Specifications Process Community/ Population Health Comment: One commenter set in the 2019 performance year. Percentage of patients with referrals, regardless of age, for which the referring provider receives a report from the provider to whom the patient was referred. Tobacco Use and Help with Quitting Among Adolescents: The percentage of adolescents 12 to 20 years of age with a primary care visit during the measurement year for whom tobacco use status was documented and received help with quitting if identified as a tobacco user. Breast Cancer measure as a new measure Services National Committee Quality Assurance · measure Response: We thank the commenter for their support. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00344 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.161</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are finalizing the General Surgery Specialty Measure Set as proposed for the 2019 Performance Period and future years. Note: Measure Q263 was incorrectly attributed to this measure set and proposed as a removal from this measure set in the proposed rule; therefore, the removal table that included measure 263 has been deleted from this final rule. Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60179 B.21. Vascular Surgery In addition to the considerations discussed in the introductory language of Table Bin this fmal rule, the Vascular Surgery specialty set takes into consideration the following criteria, which includes, but is not limited to: the measure reflects current clinical guidelines and the coding of the measure includes the specialists. We may reassess the appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. In addition, as outlined at the end of this table, we removed the following quality measures from the specialty set: Quality IDs: 257 and 423. B.21. Vascular Surgery ! (Patient Safety) N/A 023 N/A Medicare Part BClaims Measure Specifications, MIPS CQMs Specifications Process Patient Safety ! (Care Coordinat ion) 0326 047 N/A Medicare Part BClaims Measure Specifications, MIPS CQMs Specifications Process Communication and Care Coordination * 0421 128 CMS69v 7 Medicare Part BClaims Measure Specifications, eCQM Specifications, MIPS CQMs Specifications Process Community/ Population Health ! (Patient Safety) 0419 130 CMS68v 8 Medicare Part BClaims Measure Specifications, eCQM Specifications, MIPS CQMs Specifications Process Patient Safety § amozie on DSK3GDR082PROD with RULES3 Perioperative Care: Selection of Prophylactic Antibiotic - First OR Second Generation Cephalosporin: Percentage of surgical patients aged 18 years and older undergoing procedures with the indications for a f"rrst OR second generation cephalosporin prophylactic antibiotic, who had an order for a frrst OR second generation cephalosporin for BClaims Measure Specifications, MIPS CQMs Specifications VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00345 Fmt 4701 Sfmt 4725 Perioperative Care: Venous Thromboembolism (VTE) Prophylaxis (When Indicated in ALL Patients): Percentage of surgical patients aged 18 years and older undergoing procedures for which venous thromboembolism (VTE) prophylaxis is indicated in all patients, who had an order for Low Molecular Weight Heparin (LMWH), Low-Dose Unfractionated Heparin (LDUH), adjusted-dose warfarin, fondaparinux or mechanical prophylaxis to be given within 24 hours prior to incision time or within 24 hours after end time. Advance Care Plan: Percentage of patients aged 65 years and older who have an advance care plan or surrogate decision maker documented in the medical record or documentation in the medical record that an advance care plan was discussed but the patient did not wish or was not able to name a surrogate decision maker or advance care Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up Plan: Percentage of patients aged 18 years and older with a BMI documented during the current encounter or during the previous 12 months AND with a BMI outside of normal parameters, a follow-up plan is documented during the encounter or during the previous 12 months ofthe current encounter. Normal Parameters: Age 18 years and older BMI => 18.5 and< 25 Documentation of Current Medications in the Medical Record: Percentage of visits for patients aged 18 years and older for which the eligible professional or eligible clinician attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list must include ALL known prescriptions, over-thecounters, herbals, and vitamin/mineral/dietary (nutritional) supplements AND must contain the medications' name, dosage, frequency and route of administration. E:\FR\FM\23NOR3.SGM 23NOR3 Society of Plastic Surgeons American Society of Plastic Surgeons National Committee Quality Assurance Centers for Medicare & Medicaid Services Centers for Medicare & Medicaid Services ER23NO18.162</GPH> ! (Patient Safety) 60180 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations v7 BClaims Measure Specifications, eCQM Specifications, CMSWeb Interface Measure Specifications, MIPS CQMs Specifications CMS165 v7 Part BClaims Measure Specifications, eCQM Specifications, CMSWeb Interface Measure Specifications, MIPS CQMs Population Health Screening and Cessation Intervention: a. Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months. b. Percentage of patients aged 18 years and older who were screened for tobacco use and identified as a tobacco user who received tobacco cessation intervention. c. Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user. Controlling High Blood Pressure: Percentage of patients 18-85 years of age who had a diagnosis of hypertension and whose blood pressure was adequately controlled (<140/90 mmHg) during the measurement period. Consortium for Performance Improvement Foundation (PCPI®) § ! (Outcome ) 0018 ! (Outcome ) N/A 258 N/A MIPSCQMs Specifications Patient Safety Rate of Open Elective Repair of Small or Moderate Non-Ruptured Infrarenal Abdominal Aortic Aneurysms (AAA) without Major Complications (Discharged to Home by PostOperative Day #7): Percent of patients undergoing open repair of small or moderate sized non-ruptured infrarenal abdominal aortic aneurysms who do not experience a major complication (discharge to Society for Vascular Surgeons ! (Outcome ) N/A 259 N/A MIPSCQMs Specifications Patient Safety Society for Vascular Surgeons ! (Outcome ) N/A 260 N/A MIPSCQMs Specifications Patient Safety Rate ofEndovascular Aneurysm Repair (EVAR) of Small or Moderate Non-Ruptured lnfrarenal Abdominal Aortic Aneurysms (AAA) without Major Complications (Discharged at Home by Post-Operative Day #2): Percent of patients undergoing endovascular repair of small or moderate non-ruptured infrarenal abdominal aortic aneurysms (AAA) that do not experience a major complication (discharged to home no later than Rate of Carotid Endarterectomy (CEA) for Asymptomatic Patients, without Major Complications (Discharged to Home by PostOperative Day #2): Percent of asymptomatic patients undergoing CEA who are discharged to home no later than post- N/A 317 CMS22v 7 Medicare Part BClaims Measure Specifications, eCQM Specifications, MIPS CQMs Specifications Preventive Care and Screening: Screening for High Blood Pressure and Follow-Up Documented: Percentage of patients aged 18 years and older seen during the reporting period who were screened for high blood pressure AND a recommended follow-up plan is documented based on the current blood pressure (BP) reading as indicated. Centers for Medicare & Medicaid Services VerDate Sep<11>2014 236 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Clinical Care Process Frm 00346 Community I Population Health Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 Committee Quality Assurance Society for Vascular Surgeons ER23NO18.163</GPH> amozie on DSK3GDR082PROD with RULES3 B.21. Vascular Surgery Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60181 B.21. Vascular Surgery Society for Vascular Surgeons N/A 344 N/A MIPSCQMs Specifications Outcome Effective Clinical Care ! (Outcome ) 1543 345 N/A MIPSCQMs Specifications Outcome Effective Clinical Care Society for Vascular Surgeons ! (Outcome ) 1540 346 N/A MIPSCQMs Specifications Outcome Effective Clinical Care Society for Vascular Surgeons ! (Outcome ) 1534 347 N/A MIPSCQMs Specifications Outcome Patient Safety ! (Outcome N/A 357 N/A MIPSCQMs Specifications Outcome Effective Clinical Care (Care Coordinat ion) Specifications CaregiverCentered Experience and Outcomes 7 Specifications, MIPS CQMs Specifications Communication and Care Coordination N/A 402 N/A MIPSCQMs Specifications Process Community/ Population Health ! (Outcome) 1523 417 N/A MIPSCQMs Specifications Outcome Patient Safety ! (Outcome) N/A 420 N/A MIPSCQMs Specifications Patient Reported Outcome Effective Clinical Care VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00347 Fmt 4701 Sfmt 4725 Rate ofEndovascular Aneurysm Repair (EVAR) of Small or Moderate Non-Ruptured Infrarenal Abdominal Aortic Aneurysms (AAA) Who Are Discharged Alive: Percent of patients undergoing endovascular repair of small or moderate non-ruptured infrarenal abdominal aortic who are alive. Surgical Site Infection (SSI): Percentage of patients aged 18 years and older who had a site infection Patient-Centered Surgical Risk Assessment and Communication: Percentage of patients who underwent a nonemergency surgery who had their personalized risks of postoperative complications assessed by their surgical team prior to surgery using a clinical data-based, patient-specific risk calculator and who received personal discussion of those risks with the Closing the Referral Loop: Receipt of Specialist Report: Percentage of patients with referrals, regardless of age, for which the referring provider receives a report from the provider to whom the patient was referred. Tobacco Use and Help with Quitting Among Adolescents: The percentage of adolescents 12 to 20 years of age with a primary care visit during the measurement year for whom tobacco use status was documented and received help with quitting if identified as a tobacco user. Rate of Open Repair of Small or Moderate Abdominal Aortic Aneurysms (AAA) Where Patients Are Discharged Alive: Percentage of patients undergoing open repair of small or moderate non-ruptured infrarena1 abdominal aortic aneurysms (AAA) who are alive. Varicose Vein Treatment with Saphenous Ablation: Outcome Survey: Percentage of patients treated for varicose veins (CEAP C2-S) who are treated with saphenous ablation (with or without that E:\FR\FM\23NOR3.SGM 23NOR3 Society for Vascular Surgeons American College of College of Surgeons Medicare& Medicaid Services National Committee Quality Assurance Society for Vascular Surgeons Society of Interventional Radiology ER23NO18.164</GPH> (Patient Experienc e) amozie on DSK3GDR082PROD with RULES3 Rate of Carotid Artery Stenting (CAS) for Asymptomatic Patients, Without Major Complications (Discharged to Home by PostOperative Day #2): Percent of asymptomatic patients undergoing CAS who are discharged to home no later than post#2. ! (Outcome ) 60182 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.21. Vascular Surgery N/A 441 N/A MIPSCQMs Specifications Intermed iate Outcome Effective Clinical Care Ischemic Vascular Disease All or None Outcome Measure (Optimal Control): The IVD AU-or-None Measure is one outcome measure (optimal control). The measure contains four goals. All four goals within a measure must be reached in order to meet that measure. The numerator for the ali-or-none measure should be collected from the organization's total IVD denominator. Ali-or-None Outcome Measure (Optimal Control)Using the IVD denominator optimal results include: • Most recent blood pressure (BP) measurement is less than or equal to 140/90 mm Hg; and • Most recent tobacco status is Tobacco Free; and • Daily Aspirin or Other Antiplate1et Unless Contraindicated; and • Statin Use Unless Contraindicated. We did not receive specific comments regarding the measures included in this specialty measure set. amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are VerDate Sep<11>2014 19:26 Nov 21, 2018 Wisconsin Collaborative for Healthcare Quality (WCHQ) for the 2019 Performance Period and future Jkt 247001 PO 00000 Frm 00348 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.165</GPH> ! (Outcome) Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60183 B.21. Vascular Surgery (continued) 1519 257 N/A MIPS CQMs Specifications Process Effective Clinical Care Statin Therapy at Discharge after Lower Extremity Bypass (LEB): Percentage of patients aged 18 years and older undergoing infra-inguinal lower extremity bypass who are prescribed a statin medication at discharge. Society for Vascular Surgeons 0465 423 N/A Medicare Part B Claims Measure Specifications, MIPS CQMs Specifications Process Effective Clinical Care Perioperative Anti-platelet Therapy for Patients Undergoing Carotid Endarterectomy: Percentage of patients undergoing carotid endarterectomy (CEA) who are taking an anti-platelet agent within 48 hours prior to surgery and are prescribed this medication at hospital Society for Vascular Surgeons This measure is being removed from the 2019 program based on the detailed rationale described below for this measure in "Table C: Quality Measures Finalized for Removal in the 2021 MIPS Payment Year and Future Years." This measure is being removed from the 2019 program based on the detailed rationale described below for this measure in "Table C: Quality Measures Finalized for Removal in the 2021 MIPS Payment Year Comment: One commenter stated that measure Q257: Statin Therapy at Discharge after Lower Extremity Bypass (LEB) is not duplicative of the new measure for Ischemic Vascular Disease- Use of Aspirin or Anti-platelet Medication proposed for 2019. An important part of this measure is its timeframe. In many institutions, antiplatelet agents are stopped 7 days prior to any procedure/operation. Ensuring that the patient stays on the antiplatelet agent in the pre-operative period often requires extra effort and coordination so the commenter believed measure Q257 should be maintained for 2019. The benefit ofstatins has been well-documented. Response: We agree with the commenter that it is not duplicative of a proposed measure Ischemic Vascular Disease - Use of Aspirin or Anti-platelet Medication. We cited that this measure was duplicative of measure Q438: Statin Therapy for the Prevention and Treatment of Cardiovascular Disease. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00349 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.166</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are finalizing the removal of measures from the Vascular Surgery Specialty Measure Set as proposed for the 2019 Performance Period and 60184 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.22. Thoracic Surgery In addition to the considerations discussed in the introductory language of Table Bin this fmal rule, the Thoracic Surgery specialty set takes into consideration the following criteria, which includes, but is not limited to: the measure reflects current clinical guidelines and the coding of the measure includes the specialists. We may reassess the appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. In addition, as outlined at the end ofthis table, we removed the following quality measures from the specialty set: Quality IDs: 043, 236, and 441. B.22. Thoracic Surgery 0268 021 N/A Medicare Part BClaims Measure Specifications, MIPS CQMs Specifications Process Patient Safety ! (Patient Safety) N/A 023 N/A Medicare Part BClaims Measure Specifications, MIPS CQMs Specifications Process Patient Safety 0326 047 N/A Part B Claims Measure Specifications, MIPS CQMs Specifications Process amozie on DSK3GDR082PROD with RULES3 (Care Coordinat ion) and Care Coordination ! (Patient Safety) 0419 130 CMS68 v8 Medicare Part BClaims Measure Specifications, eCQM Specifications, MIPS CQMs Specifications Process Patient Safety ! (Outcome ) 0129 164 N!A MIPS CQMs Specifications Outcome Effective Clinical Care ! (Outcome ) 0130 165 N/A MIPS CQMs Specifications Outcome Effective Clinical Care VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00350 Fmt 4701 Sfmt 4725 Perioperative Care: Selection of Prophylactic Antibiotic - First OR Second Generation Cephalosporin: Percentage of surgical patients aged 18 years and older undergoing procedures with the indications for a first OR second generation cephalosporin prophylactic antibiotic, who had an order for a first OR second generation for antimicrobial Perioperative Care: Venous Thromboembolism (VTE) Prophylaxis (When Indicated in ALL Patients):Percentage of surgical patients aged 18 years and older undergoing procedures for which venous thromboembolism (VTE) prophylaxis is indicated in all patients, who had an order for Low Molecular Weight Heparin (LMWH), Low-Dose Unfractionated Heparin (LDUH), adjusted-dose warfarin, fondaparinux or mechanical prophylaxis to be given within 24 hours prior to incision time or within 24 hours after end time. Advance Care Plan: Percentage of patients aged 65 years and older who have an advance care plan or surrogate decision maker documented in the medical record or documentation in the medical record that an advance care plan was discussed but the patient did not wish or was not able to name a surrogate decision maker or provide an advance care Documentation of Current Medications in the Medical Record: Percentage of visits for patients aged 18 years and older for which the eligible professional or eligible clinician attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list must include ALL known prescriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutritional) supplements AND must contain the medications' name, dosage, frequency and route of administration. Coronary Artery Bypass Graft (CABG): Prolonged Intubation: Percentage of patients aged 18 years and older undergoing isolated CABG surgery who require intubation> 24 hours. Coronary Artery Bypass Graft (CABG): Deep Sternal Wound Infection Rate: Percentage of patients aged 18 years and older undergoing isolated CABG surgery who, within 30 days postoperatively, develop deep sternal wound infection and/or E:\FR\FM\23NOR3.SGM 23NOR3 American Society of Plastic Surgeons American Society of Plastic Surgeons Committee Quality Assurance Centers for Medicare& Medicaid Services Society of Thoracic Surgeons Society of Thoracic Surgeons ER23NO18.167</GPH> ! (Patient Safety) Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60185 B.22. Thoracic Surgery Surgeons ! (Outcome ) 0114 167 N/A MIPS CQMs Specifications Outcome Effective Clinical Care ! (Outcome ) 0115 168 N/A MIPS CQMs Specifications Outcome Effective Clinical Care Coronary Artery Bypass Graft (CABG): Surgical Re-Exploration: Percentage of patients aged 18 years and older undergoing isolated CABG surgery who require a return to the operating room (OR) during the current hospitalization for mediastinal bleeding with or without tamponade, graft occlusion, Society of Thoracic Surgeons § 0028 226 CMS13 8v7 Medicare Part BClaims Measure Specifications, eCQM Specifications, CMS Web Interface Measure Specifications, MIPS CQMs Specifications Process Community/Pop ulation Health Physician Consortium for Performance Improvement Foundation (PCPI®) N/A 317 CMS22 v7 Medicare Part BClaims Measure Specifications, eCQM Specifications, MIPS CQMs Specifications Process Community /Population Health MIPS CQMs Specifications Process Person CaregiverCentered Experience and Outcomes eCQM Specifications, MIPS CQMs Specifications Process Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: a. Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months. b. Percentage of patients aged 18 years and older who were screened for tobacco use and identified as a tobacco user who received tobacco cessation intervention. c. Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user. Preventive Care and Screening: Screening for High Blood Pressure and Follow-Up Documented: Percentage of patients aged 18 years and older seen during the reporting period who were screened for high blood pressure AND a recommended follow-up plan is documented based on the current blood pressure (BP) as indicated. Patient-Centered Surgical Risk Assessment and Communication: Percentage of patients who underwent a nonemergency surgery who had their personalized risks of postoperative complications assessed by their surgical team prior to surgery using a clinical data-based, patient-specific risk calculator and who received personal discussion of those risks with the Closing the Referral Loop: Receipt of Specialist Report: Percentage of patients with referrals, regardless of age, for which the referring provider receives a report from the to whom the was referred. and Help with Quitting Among ! (Patient Experienc e) ! (Care Coordinat ion) amozie on DSK3GDR082PROD with RULES3 Coronary Artery Bypass Graft (CABG): Stroke: Percentage of patients aged 18 years and older undergoing isolated CABG surgery who have a postoperative stroke (that is, any confirmed neurological deficit of abrupt onset caused by a disturbance in blood supply to the brain) that did not resolve within 24 hours. Coronary Artery Bypass Graft (CABG): Postoperative Renal Failure: Percentage of patients aged 18 years and older undergoing isolated CABG surgery (without pre-existing renal failure) who develop VerDate Sep<11>2014 N/A 374 CMS50 v7 N/A 402 N/A 19:26 Nov 21, 2018 Jkt 247001 Communication and Care Coordination Process PO 00000 Frm 00351 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 Society of Thoracic Surgeons Centers for Medicare& Medicaid Services College of Surgeons Centers for Medicare& Medicaid Services ER23NO18.168</GPH> ! (Outcome ) 60186 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.22. Thoracic Surgery Society of Risk-Adjusted Operative Mortality for Coronary Artery Bypass Graft (CABG): Thoracic Percent of patients aged 18 years and older Surgeons undergoing isolated CABG who die, including both all deaths occurring during the hospitalization in which the CABG was performed, even if after 30 days, and those deaths occurring after discharge from the but within 30 of the Comment: One commenter noted that the correct measure steward for the following measures should be the "Society of Thoracic Surgeons": Q164: CABG: Prolonged Intubation; Q165: CABG: Deep Sternal Wound Infection Rate; Q166: CABG: Stroke; Q167: CABG: PostOp Renal Failure § 0119 445 N/A MIPS CQMs Specifications Outcome Effective Clinical Care Response: We have updated the measure steward for these measures accordingly. Comment: The commenter stated that measure Q317: Preventive Care and Screening: Screening for High Blood Pressure and Follow-Up Documented is not appropriate for the Thoracic Surgery Specialty Set and requested its removal for CY 2019. The commenter noted that blood pressure management is outside of the scope of practice of cardiothoracic surgeons. Response: We do not agree to remove the measure from the Thoracic Surgery specialty set because if the patient has an elevated blood pressure at post-op, it is within the thoracic surgeon's scope to recommend a follow-up with the patient's PCP. In addition, we believe that if the thoracic surgeon should assess a patient at pre-operatively or post-operatively, there should be blood pressure screening. Comment: One commenter supported inclusion of measures Q358: Patient-Centered Surgical Risk Assessment and Communication. Response: We thank the commenter for their support of measure Q358: Patient-Centered Surgical Risk Assessment and Communication. VerDate Sep<11>2014 19:26 Nov 21, 2018 for the 2019 Performance Period and future Jkt 247001 PO 00000 Frm 00352 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.169</GPH> amozie on DSK3GDR082PROD with RULES3 FINALACTION: Weare Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60187 B.22. Thoracic Surgery (continued) 0134 043 NIA MIPSCQMs Specifications Process Effective Clinical Care Coronary Artery Bypass Graft (CABG): Use oflnternal Mammary Artery (IMA) in Patients with Isolated CABG Surgery: Percentage of patients aged 18 years and older undergoing isolated CABG surgery who received an IMA graft. Society of Thoracic Surgeons 0018 236 CMS165 v7 Medicare Part BC!aims Measure Specifications, eCQM Specifications, CMS Web Interface Measure Specifications, MIPSCQMs Specifications Intermediate Outcome Effective Clinical Care Controlling High Blood Pressure: Percentage of patients 18-85 years of age who had a diagnosis of hypertension and whose blood pressure was adequately controlled ( <140/90mmHg) during the measurement period. National Committee for Quality Assurance This measure is being removed from the 20 19 program based on the detailed rationale described below for this measure in "Table C: Quality Measures Finalized for Removal in the 2021 MIPS Payment Year and Future Years." We agree with specialty society feedback to remove this measure from this specialty set because blood pressure control is managed by care team members other than the cardiothoracic surgeon. Blood pressure outcomes are more likely attributed to the primary care provider or cardiologist. These eligible clinicians are part of the core treatment team that is responsible for the ongoing We agree Ischemic Vascular Disease All or society feedback to remove Collaborati None Outcome Measure this measure from this (Optimal Control): The IVD Alive for specialty set because the or-None Measure is one outcome Healthcare measure (optimal control). The Quality outcomes and medications measure contains four goals. All within the measure are (WCHQ) four goals within a measure must managed by care team be reached in order to meet that members other than the cardiothoracic surgeon. measure. The numerator for the allBlood pressure and tobacco or-none measure should be cessation outcomes are more collected from the organization's likely attributed to the total IVD denominator. All-orprimary care provider or None Outcome Measure (Optimal cardiologist. These eligible Control)clinicians are part of the Using the IVD denominator core treatment team that is optimal results include: responsible for the ongoing • Most recent blood pressure (BP) ischemic vascular disease measurement is less than or care. equal to 140/90 mm Hg; and • Most recent tobacco status is Tobacco Free; and • Daily Aspirin or Other Antiplatelet Unless Contraindicated; and • Statin Use Unless Contraindicated. Comment: One commenter opposed removal of measure Q043: CABG: Use oflnternal Mammary Artery (IMA) in Patients with Isolated CABG Surgery due to topped out status. The commenter stated that IMA use is so important to long-term graft patency and ifCMS removes this life-saving measure from MIPS, there will be little incentive for clinicians to report it and thus, a natural tendency for performance to slip without anyone's knowledge. The commenter opposed the proposal to modify the existing topped-out measure policy to allow for the immediate removal of highly topped out measures. 441 MIPSCQMs Specifications Outcome Clinical Care VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00353 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.170</GPH> amozie on DSK3GDR082PROD with RULES3 Response: This measure leaves little room for improvement as reflected in the 2018 MIPS Benchmark Results as an average performance rate of 99 percent which supports the removal as it is a standard of care. The measure has limited opportunity to improve clinical outcomes since performance on this measure is extremely high and unvarying and restricts the creation of meaningful benchmarks. This provides little incentive for clinicians to report the measure since the performance data does not allow for maximum to be awarded. We advise the commenter to collaborate with measure to submit more robust or outcome measures 60188 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations the Call for Measures process. Comment: One commenter did not see that measure Q441: Ischemic Vascular Disease All or None Outcome Measure (Optimal Control) was in the removal table for Thoracic Surgery in the proposed rule, but supported its removal since not all of the four goals reflected in the measure are appropriate for acute surgical patients. Response: We thank the commenter for feedback regarding the removal of this measure. We agree with the commenter's assessment that not all of the goals are applicable for this specialty. The measure was inadvertently not included in this specialty measure set tables but it was our intent to remove this measure from this specialty measure set based on similar feedback received prior to the public comment period. Comment: Several commenters supported the removal of measure Q236: Controlling High Blood Pressure. Blood pressure control is managed by care team members other than the cardiothoracic surgeon. Response: We thank the commenters for supporting the removal of measure Q236: Controlling High Blood Pressure. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00354 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.171</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are finalizing the removal of measures from the Thoracic Surgery Specialty Measure Set as proposed for the 2019 Performance Period and future years. Note: We are also including the removal ofQ441 based on public comments above supporting removal. 60189 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.23. Urology In addition to the considerations discussed in the introductory language of Table Bin this final rule, the Urology specialty set takes into consideration the following criteria, which includes, but is not limited to: the measure reflects current clinical guidelines and the coding of the measure includes the specialists. We may reassess the appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. B.23. Urology NIA 023 NIA (Care Coordinat ion) NIA 048 NIA (Patient Experienc e) 0389 102 ! (Appropri ate Use) amozie on DSK3GDR082PROD with RULES3 0390 VerDate Sep<11>2014 CMS129 v8 104 19:26 Nov 21, 2018 Jkt 247001 Medicare Part BCiaims Measure Specifications, MIPSCQMs Specifications Process Part BClaims Measure Specifications, MIPSCQMs Specifications Process Medicare Part BClaims Measure Specifications, MIPSCQMs Specifications Process Effective Clinical Care Part BClaims Measure Specifications, MIPSCQMs Specifications Process Person CaregiverCentered Experience and Outcomes eCQM Specifications, MIPSCQMs Specifications Process MIPSCQMs Specifications Process PO 00000 Patient Safety and Care Coordination Frm 00355 Efficiency and Cost Reduction Care Fmt 4701 Sfmt 4725 Perioperative Care: Venous Thromboembolism (VTE) Prophylaxis (When Indicated in ALL Patients): Percentage of surgical patients aged 18 years and older undergoing procedures for which venous thromboembolism (VTE) prophylaxis is indicated in all patients, who had an order for Low Molecular Weight Heparin (LMWH), Low-Dose Unfractionated Heparin (LDUH), adjusted-dose warfarin, fondaparinux or mechanical prophylaxis to be given within 24 hours prior to incision time or within 24 hours after surgery end time. Advance Care Plan: Percentage of patients aged 65 years and older who have an advance care plan or surrogate decision maker documented in the medical record or documentation in the medical record that an advance care plan was discussed but the patient did not wish or was not able to name a surrogate decision maker or an advance care Urinary Incontinence: Assessment of Presence or Absence of Urinary Incontinence in Women Aged 65 Years and Older: Percentage of female patients aged 65 years and older who were assessed for the presence or absence of urinary incontinence within 12 months. Urinary Incontinence: Assessment of Presence or Absence Plan of Care for Urinary Incontinence in Women Aged 65 Years and Older: Percentage of female patients aged 65 years and older with a diagnosis of urinary incontinence with a documented plan of care for urinary Bone Scan for staging Low Risk Prostate Cancer Patients: Percentage of patients, regardless of age, with a diagnosis of prostate cancer at low (or very low) risk of recurrence receiving interstitial prostate brachytherapy, OR external beam radiotherapy to the prostate, OR radical prostatectomy, OR cryotherapy who did not have a bone scan performed at any time since diagnosis of prostate cancer. Prostate Cancer: Combination Androgen Deprivation Therapy for High Risk or Very High Risk Prostate Cancer: Percentage of patients, regardless of age, with a diagnosis of prostate cancer at high or very high risk of recurrence receiving external beam radiotherapy to the prostate who were prescribed androgen deprivation therapy in combination with external beam to the E:\FR\FM\23NOR3.SGM 23NOR3 American Society of Plastic Surgeons Committee for Quality Assurance National Committee for Quality Assurance Committee for Quality Assurance Consortium Performance Improvement Foundation (PCPI®) Urological Association Education and Research ER23NO18.172</GPH> ! (Patient Safety) Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations § 0062 119 CMS134 v7 eCQM Specifications, MIPSCQMs Specifications Process * 0421 128 CMS69v 7 Medicare Part BClaims Measure Specifications, eCQM Specifications, MIPSCQMs Specifications Process ! (Patient Safety) 0419 130 CMS68v 8 Medicare Part BClaims Measure Specifications, eCQM Specifications, MIPSCQMs Specifications Process ! (Care Coordinat ion) 0420 131 N/A Medicare Part BCiaims Measure Specifications, MIPSCQMs Specifications Process § 0028 226 CMS138 v7 Medicare Part BClaims Measure Specifications, eCQM Specifications, CMS Web Interface Measure Specifications, MIPSCQMs Specifications ! N!A 265 N!A N/A 317 N/A 358 § amozie on DSK3GDR082PROD with RULES3 ! (Patient Experienc e) VerDate Sep<11>2014 19:26 Nov 21, 2018 Effective Clinical Diabetes: Medical Attention for Nephropathy: Care The percentage of patients 18-75 years of age with diabetes who had a nephropathy screening test or evidence of nephropathy during the measurement period. Community/ Preventive Care and Screening: Body Mass Population Index (BMI) Screening and Follow-Up Plan: Percentage of patients aged 18 years and older Health with a BMI documented during the current encounter or during the previous 12 months AND with a BMI outside of normal parameters, a follow-up plan is documented during the encounter or during the previous 12 months of the current encounter. Normal Parameters: Age 18 years and older BMI => 18.5 and< 25 kg/m2. Patient Safety Documentation of Current Medications in the Medical Record: Percentage of visits for patients aged 18 years and older for which the eligible professional or eligible clinician attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list must include ALL known prescriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutritional) supplements AND must contain the medications' name, dosage, frequency and route of administration. Communication Pain Assessment and Follow-Up: and Care Percentage of visits for patients aged 18 years Coordination and older with documentation of a pain assessment using a standardized tool(s) on each visit AND documentation of a follow-up plan when pain is present. National Committee for Quality Assurance Process Community/Pop ulation Health Physician Consortium for Performance Improvement Foundation (PCPI®) MIPS CQMs Specifications Process Communication and Care Coordination CMS22v 7 Medicare Part BCiaims Measure Specifications, eCQM Specifications, MIPSCQMs Specifications Process Community /Population Health N!A MIPS CQMs Specifications Process Person and CaregiverCentered Experience and Outcomes Jkt 247001 PO 00000 Frm 00356 Fmt 4701 Sfmt 4725 Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: a. Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months. b. Percentage of patients aged 18 years and older who were screened for tobacco use and identified as a tobacco user who received tobacco cessation intervention. c. Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user. Biopsy Follow-Up: Percentage of new patients whose biopsy results have been reviewed and communicated to the primary care/referring physician and patient by the performing physician. Preventive Care and Screening: Screening for High Blood Pressure and Follow-Up Documented: Percentage of patients aged 18 years and older seen during the reporting period who were screened for high blood pressure AND a recommended follow-up plan is documented based on the current blood pressure (BP) reading as indicated. Patient-Centered Surgical Risk Assessment and Communication: Percentage of patients who underwent a nonemergency surgery who had their personalized risks of postoperative complications assessed by E:\FR\FM\23NOR3.SGM 23NOR3 Centers for Medicare& Medicaid Services Centers for Medicare & Medicaid Services Centers for Medicare & Medicaid Services American Academy of Dermatology Centers for Medicare & Medicaid Services American College of Surgeons ER23NO18.173</GPH> 60190 ! (Care Coordinat ion) N/A 374 CMS50v 7 eCQM Specifications, MIPSCQMs Specifications Process Communication and Care Coordination N/A 428 N/A MIPS CQMs Specifications Process Effective Clinical Care N/A 429 N/A Process Patient Safety 2152 431 N/A Medicare Part BClaims Measure Specifications, MIPSCQMs Specifications MIPSCQMs Specifications Process Community/ Population Health ! (Outcome ) N/A 432 N/A MIPS CQMs Specifications Outcome Patient Safety ! (Outcome ) N/A 433 N/A MIPS CQMs Specifications Outcome Patient Safety ! (Outcome ) N/A 434 N/A MIPS CQMs Specifications Outcome Patient Safety N/A 462 CMS645 v2 eCQM Specifications Process Effective Clinical Care amozie on DSK3GDR082PROD with RULES3 ! (Patient Safety) VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00357 Fmt 4701 Sfmt 4725 their surgical team prior to surgery using a clinical data-based, patient-specific risk calculator and who received personal discussion of those risks with the surgeon. Closing the Referral Loop: Receipt of Specialist Report: Percentage of patients with referrals, regardless of age, for which the referring provider receives a report from the provider to whom the patient was referred. Pelvic Organ Prolapse: Preoperative Assessment of Occnlt Stress Urinary Incontinence: Percentage of patients undergoing appropriate preoperative evaluation of stress urinary incontinence prior to pelvic organ prolapse surgery per ACOG/AUGS/AUA guidelines. Pelvic Organ Prolapse: Preoperative Screening for Uterine Malignancy: Percentage of patients who are screened for uterine malignancy prior to vaginal closure or obliterative surgery for pelvic organ prolapse. Preventive Care and Screening: Unhealthy Alcohol Use: Screening & Brief Counseling: Percentage of patients aged 18 years and older who were screened for unhealthy alcohol use using a systematic screening method at least once within the last 24 months AND who received brief counseling if identified as an unhealthy alcohol user. Proportion of Patients Sustaining a Bladder Injury at the Time of any Pelvic Organ Prolapse Repair: Percentage of patients undergoing any surgery to repair pelvic organ prolapse who sustains an injury to the bladder recognized either during or within 30 days after surgery. Proportion of Patients Sustaining a Bowel Injnry at the time of any Pelvic Organ Prolapse Repair: Percentage of patients undergoing surgical repair of pelvic organ prolapse that is complicated by a bowel injury at the time of index surgery that is recognized intraoperatively or within 30 days after surgery. Proportion of Patients Sustaining a Ureter Injury at the Time of any Pelvic Organ Prolapse Repair: Percentage of patients undergoing pelvic organ prolapse repairs who sustain an injury to the ureter recognized either during or within 30 days after surgery. Bone Density Evaluation for Patients with Prostate Cancer and Receiving Androgen Deprivation Therapy: Patients determined as having prostate cancer who are currently starting or undergoing androgen deprivation therapy (ADT), for an anticipated period of 12 months or greater and who receive an initial bone density evaluation. The bone density evaluation must be prior to the start of ADT or within 3 months of the start of ADT. E:\FR\FM\23NOR3.SGM 23NOR3 60191 Centers for Medicare & Medicaid Services American Urogynecologic Society American Urogynecologic Society Physician Consortium for Performance Improvement American Urogynecologic Society American Urogynecologic Society American Urogynecologic Society Oregon Urolog) Institute ER23NO18.174</GPH> Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60192 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations Comment: One commenter noted that the proposed rule Urology Specialty Measure Set listed a measure for Benign Prostatic Hyperplasia and questioned its measure specifications. Response: This measure was included in error and has been removed from the fmal rule. The measure will be reviewed for future consideration. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00358 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.175</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are fmalizing the Urology Specialty Measure Set as proposed for the 2019 Performance Period and future years. Note: As noted in our responses to public comments in Table C, measure Q048 is not finalized for removal from this measure set as proposed; therefore, it is retained in this measure set for the 2019 Performance Period and future years. 60193 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.24a. Oncology In addition to the considerations discussed in the introductory language of Table B in this final rule, the Oncology specialty set takes into consideration the following criteria, which includes, but is not limited to: the measure reflects current clinical guidelines and the coding of the measure includes the specialists. We may reassess the appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. This measure set does not have any measures removed from prior years. B.24a. Oncology 047 NIA Medicare Part B Claims Measure Specifications, MIPS CQMs Specifications Process § ! (Appropri ate Use) 0389 102 CMS129v 8 eCQM Specifications, MIPS CQMs Specifications Process 0041 * 110 CMS147v 8 amozie on DSK3GDR082PROD with RULES3 Efficiency and Cost Reduction Medicare Part B Claims Measure Specifications, eCQM Specifications, CMSWeb Interface Measure Specifications, MIPSCQMs Process Community/ Population Health Advance Care Plan: Percentage of patients aged 65 years and older who have an advance care plan or surrogate decision maker documented in the medical record or documentation in the medical record that an advance care plan was discussed but the patient did not wish or was not able to name a surrogate decision maker an advance care Prostate Cancer: Avoidance of Overuse of Bone Scan for Staging Low Risk Prostate Cancer Patients: Percentage of patients, regardless of age, with a diagnosis of prostate cancer at low (or very low) risk of recurrence receiving interstitial prostate brachytherapy, OR external beam radiotherapy to the prostate, OR radical prostatectomy, OR cryotherapy who did not have a bone scan performed at time since cancer. Preventive Care and Screening: Influenza Immunization: Percentage of patients aged 6 months and older seen for a visit between October 1 and March 31 who received an influenza immunization OR who reported previous receipt of an influenza immunization. National Committee for Quality Assurance Foundation (PCPI®) Physician Consortium for Foundation (PCPI®) N/A 111 CMS127v 7 Part B Claims Measure Specifications, eCQM Specifications, MIPS CQMs Process Community/ Population Health Pneumococcal Vaccination Status for Older Adults: Percentage of patients 65 years of age and older who have ever received a pneumococcal vaccine. National Committee for Quality Assurance 0419 130 CMS68v8 Medicare Part B Claims Measure Specifications, eCQM Specifications, MIPS CQMs Specifications Process Patient Safety Documentation of Current Medications in the Medical Record: Percentage of visits for patients aged 18 years and older for which the eligible professional eligible clinician attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list must include ALL known prescriptions, over-the-counters, herbals, andvitamin/mineral/dietary (nutritional) supplements AND must contain the medications' name, dosage, frequency and Centers for Medicare& Medicaid Services (Patient Safety) VerDate Sep<11>2014 Communication and Care Coordination 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00359 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.176</GPH> 0326 (Care Coordinat ion) 60194 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.24a. Oncology * Experience and Outcome 0383 144 N/A MIPS CQMs Specifications Process 0028 226 CMS138v 7 Part BClaims Measure Specifications, eCQM Specifications, CMS Web Interface Measure Specifications, MIPS CQMs Specifications Process Part BClaims Measure Specifications, MIPSCQMs Process ! (Patient Experienc e) amozie on DSK3GDR082PROD with RULES3 ! (Care Coordinat ion) VerDate Sep<11>2014 Person and Caregiver Centered Experience and Outcome Population Health Clinical Care NIA 317 CMS22v7 Medicare Part BClaims Measure Specifications, eCQM Specifications, MIPS CQMs Specifications Process Community/ Population Health N/A 374 CMS50v7 eCQM Specifications, MIPS CQMs Specifications Process Communication and Care Coordination N/A 402 N/A MIPS CQMs Specifications Process Community/Po pulation Health 2152 431 19:26 Nov 21, 2018 Intensity Quantified: Percentage of patient visits, regardless of patient age, with a diagnosis of cancer currently receiving chemotherapy or radiation therapy in which pain intensity is quantified. Oncology: Medical and Radiation - Plan of Care for Moderate to Severe Pain: Percentage of patients, regardless of age, with a diagnosis of cancer currently receiving chemotherapy or radiation therapy who report having moderate to severe pain with a plan of care to address pain documented on or before the date of the second visit with a clinician. Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: a. Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months. b. Percentage of patients aged 18 years and older who were screened for tobacco use and identified as a tobacco user who received tobacco cessation intervention. c. Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user. Radical Prostatectomy Pathology Reporting: Percentage of radical prostatectomy pathology reports that include the pT category, the pN category, the Gleason score and a statement about margin status. Preventive Care and Screening: Screening for High Blood Pressure and Follow-Up Documented: Percentage of patients aged 18 years and older seen during the reporting period who were screened for high blood pressure AND a recommended follow-up plan is documented based on the current blood Closing the Referral Loop: Receipt of Specialist Report: Percentage of patients with referrals, regardless of age, for which the referring provider receives a report from the provider to whom the was referred. Tobacco Use and Help with Quitting Among Adolescents: The percentage of adolescents 12 to 20 years of age with a primary care visit during the measurement year for whom tobacco use status was documented and received help with quitting if identified as a tobacco user. Process Jkt 247001 PO 00000 Frm 00360 Fmt 4701 Unhealthy Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 American Society of Clinical Oncology Foundation (PCPI®) American Pathologists Centers for Medicare & Medicaid Services Centers for Medicare & Medicaid Services National Committee for Quality Assurance Physician Consortium ER23NO18.177</GPH> ! (Patient Experienc e) Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60195 B.24a. Oncology 1857 449 NIA 450 amozie on DSK3GDR082PROD with RULES3 ! (Appropri ate Use) MIPS CQMs Specifications Process MIPS CQMs Specifications Process Efficiency and Cost Reduction Cost Reduction § 1859 451 NIA MIPS CQMs Specifications Process Effective Clinical Care § ! (Patient Safety) 1860 452 N!A MIPS CQMs Specifications Process Patient Safety § ! (Appropri ate Use) 0210 453 NIA MIPS CQMs Specifications Process Effective Clinical Care § ! (Outcome ) N/A 454 N/A MIPS CQMs Specifications Outcome Effective Clinical Care § 0213 455 N/A MIPS CQMs Specifications Outcome VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00361 Effective Clinical Care Fmt 4701 Sfmt 4725 Trastuzumab Received By Patients With AJCC Stage I (Tlc) -III And HER2 Positive Breast Cancer Receiving Adjuvant Chemotherapy: Proportion of female patients (aged 18 years and older) with AJCC stage I (Tic)- III, human epidermal growth factor receptor 2 (HER2) positive breast cancer receiving adjuvant chemotherapy who are also trastuzumab. KRAS Gene Mutation Testing Performed for Patients with Metastatic Colorectal Cancer who receive Anti-epidermal Growth Factor Receptor (EGFR) Monoclonal Antibody Therapy:: Percentage of adult patients (aged 18 or over) with metastatic colo rectal cancer who receive anti-epidermal growth factor receptor monoclonal antibody therapy for whom KRAS mutation was Patients with Metastatic Colorectal Cancer and RAS (KRAS or NRAS) Gene Mutation Spared Treatment with Antiepidermal Growth Factor Receptor (EGFR) Monoclonal Antibodies: Percentage of adult patients (aged 18 or over) with metastatic colorectal cancer and KRAS gene mutation spared treatment with antiEGFR monoclonal antibodies. Percentage of Patients Who Died from Cancer Receiving Chemotherapy in the Last 14 Days of Life (lower score - better): Percentage of patients who died from cancer receiving chemotherapy in the last 14 days of life. Percentage of Patients who Died from Cancer with More than One Emergency Department Visit in the Last 30 Days of Life (lower score - better): Proportion of patients who died from cancer with more than one emergency room visit in the last 30 days oflife. Percentage of Patients Who Died from Cancer Admitted to the Intensive Care E:\FR\FM\23NOR3.SGM 23NOR3 Foundation (PCPI) American Society of Clinical Oncology Society of Clinical Oncology American Society of Clinical Oncology American Society of Clinical Oncology American Society of Clinical Oncology American Society of Clinical Oncology American Society of Clinical ER23NO18.178</GPH> § ! (Appropri ate Use) Counseling: Percentage of patients aged 18 years and older who were screened for unhealthy alcohol use using a systematic screening method at least once within the last 24 months AND who received brief counseling if identified as an alcohol user. HER2 Negative or Undocumented Breast Cancer Patients Spared Treatment with HER2-Targeted Therapies: Percentage of female patients (aged 18 years and older) with breast cancer who are human epidermal growth factor receptor 2 (HER2) negative who are not administered HER2- 60196 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.24a. Oncology § ! (Appropria te Use) 0215 456 N/A MIPS CQMs Specifications Process Effective Clinical Care Percentage of Patients Who Died from Cancer Not Admitted To Hospice (lower score - better): Proportion of patients who died from cancer American Society of Clinical Oncology § ! (Outcome) 0216 457 N/A MIPSCQMs Specifications Outcome Effective Clinical Care American Society of Clinical Oncology N/A 462 CMS645v 2 eCQM Specifications Process Effective Clinical Care N/A 474 N/A MIPS CQMs Specifications Process Community/Pop ulation Health Percentage of Patients Who Died from Cancer Admitted to Hospice for Less than 3 days (lower score- better): Percentage of patients who died from cancer, and admitted to hospice and spent less than 3 there. Bone Density Evaluation for Patients with Prostate Cancer and Receiving Androgen Deprivation Therapy: Patients determined as having prostate cancer who are currently starting or undergoing androgen deprivation therapy (ADT), for an anticipated period of 12 months or greater and who receive an initial bone density evaluation. The bone density evaluation must be prior to the start of ADT or within 3 months of the start of ADT. Zoster (Shingles) Vaccination: The percentage of patients 50 years of age and older who have a Varicella Zoster Oregon Urology Institute PPRNet We did not receive specific comments regarding the measures included in this specialty measure set. VerDate Sep<11>2014 19:26 Nov 21, 2018 for the 2019 Performance Period and future Jkt 247001 PO 00000 Frm 00362 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.179</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: Weare 60197 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.24b. Radiation Oncology In addition to the considerations discussed in the introductory language of Table Bin this fmal rule, the Radiation Oncology specialty set takes into consideration the following criteria, which includes, but is not limited to: the measure reflects current clinical guidelines and the coding of the measure includes the specialists. We may reassess the appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. In addition, as outlined at the end of this table, we removed the following quality measure from the specialty set: Quality ID: 156. B.24b. Radiation Oncology ! (Appropriat e Use) v8 Reduction 0384 143 ! (Patient Experience ) 0383 144 CMSI57 v7 eCQM Specifications, MIPS CQMs Specifications Process N/A MIPSCQMs Specifications Process ! (Patient Experience ) Person and Caregiver Centered Experience and Outcome Person and Caregiver Centered Experience and Outcome Prostate Cancer: Avoidance ofOvernse of Bone Scan for Staging Low Risk Prostate Cancer Patients: Percentage of patients, regardless of age, with a diagnosis of prostate cancer at low (or very low) risk of recurrence receiving interstitial prostate brachytherapy, OR external beam radiotherapy to the prostate, OR radical prostatectomy, OR cryotherapy who did not have a bone scan performed at any time since diagnosis of Oncology: Medical and Radiation - Pain Intensity Quantified: Percentage of patient visits, regardless of patient age, with a diagnosis of cancer currently receiving chemotherapy or radiation therapy in which Oncology: Medical and Radiation- Plan of Care for Moderate to Severe Pain: Percentage of patients, regardless of age, with a diagnosis of cancer currently receiving chemotherapy or radiation therapy who report having moderate to severe pain with a plan of care to address pain documented on or before Performance Improvement Foundation (PCPI®) Consortium Performance Improvement Foundation American Society of Clinical Oncology Comment: One commenter requested that its specialty be able to report the entire specialty specific measure set through a single collection type of their choice. The commenter was concerned that the eCQM reporting mechanism is not available for all three measures within the Radiation Oncology subspecialty measure set, which inhibits complete quality reporting of the subspecialty measure set via an EHR. The commenter urged CMS to continue to work with third-party measure stewards to allow EHR submission of each of the quality measures in the radiation oncology measure set and alleviate reporting burden. Response: We regularly evaluate to identifY measures that could be specified as an eCQM. There are some measures that are currently unable to be captured via an eCQM Specification but we will continue to work with the measure stewards to determine the future implementation of an eCQM Specification for measure Q144. VerDate Sep<11>2014 19:26 Nov 21, 2018 for the 2019 Performance Period and future Jkt 247001 PO 00000 Frm 00363 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.180</GPH> amozie on DSK3GDR082PROD with RULES3 FINALACTION: Weare 60198 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.24b. Radiation Oncology BClaims Measure Specifications, MIPSCQMs Specifications Safety Oncology: Radiation Dose Limits to Normal Tissues: Percentage of patients, regardless of age, with a diagnosis of breast, rectal, pancreatic or lung cancer receiving 3D conformal radiation therapy who had documentation in medical record that radiation dose limits to normal tissues were established prior to the initiation of a course of 3D conformal radiation for Society for Radiation Oncology measure removed from the 2019 program based on the detailed rationale described below for this measure in "Table C: Quality Measures Finalized for Removal in the 2021 MIPS Payment Year and Future Years." We did not receive specific comments regarding the measures removed from this specialty measure set. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00364 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.181</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are finalizing the removal of measures from the Radiation Oncology Specialty Measure Set as proposed for the 2019 Performance Period and future 60199 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.25. Infectious Disease In addition to the considerations discussed in the introductory language of Table B in this final rule, the Infectious Disease specialty set takes into consideration the following criteria, which includes, but is not limited to: the measure reflects current clinical guidelines and the coding of the measure includes the specialists. We may reassess the appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. In addition, as outlined at the end of this table, we removed the following quality measures from the specialty set: Quality IDs: 065, 066, 091, 093, 116, 128, 176, 226, 275, 331, 332, 333, 334, 337, 387, 390, 394,400, 401, and 447. B.25. Infectious Disease 0041 110 CMS147 v8 Medicare Part BClaims Measure Specifications, eCQM Specifications, CMS Web Interface Measure Specifications, MIPS CQMs Process Community/ Population Health Preventive Care and Screening: Influenza Immunization: Percentage of patients aged 6 months and older seen for a visit between October 1 and March 31 who received an influenza immunization OR who reported previous receipt of an influenza immunization. * N/A 111 CMS127 v7 Medicare Part BClaims Measure Specifications, eCQM Specifications, MIPSCQMs Process Community/ Population Health Pneumococcal Vaccination Status for Older Adults: Percentage of patients 65 years of age and older who have ever received a pneumococcal vaccine. National Committee for Quality ! (Patient Safety) 0419 130 CMS68v 8 Medicare Part BClaims Measure Specifications, eCQM Specifications, MIPS CQMs Specifications Process Patient Safety Documentation of Current Medications in the Medical Record: Percentage of visits for patients aged 18 years and older for which the eligible professional or eligible clinician attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list must include ALL known prescriptions, over-thecounters, herbals, and vitamin/mineral/dietary (nutritional) supplements AND must contain the medications' name, dosage, frequency and Centers for Medicare& Medicaid § 0409 205 N/A MIPS CQMs Specifications Process Effective Clinical Care National Committee for Quality § ! (Outcome) 2082 338 N/A MIPS CQMs Specifications Outcome Effective Clinical Care HIV/AIDS: Sexually Transmitted Disease Screening for Chlamydia, Gonorrhea, and Syphilis: Percentage of patients aged 13 years and older with a diagnosis ofHIVIAIDS for whom chlamydia, gonorrhea and syphilis screenings were performed at least once · ofHIV infection. since the HIV Viral Load Suppression: The percentage of patients, regardless of age, with a diagnosis ofHIV with a HIV viral load less than 200 copies/mL at last HIV viral load test during the measurement amozie on DSK3GDR082PROD with RULES3 VerDate Sep<11>2014 and Cost Reduction Specifications 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00365 Fmt 4701 Sfmt 4725 Frequency: Percentage of patients, regardless of age with a diagnosis ofHIV who had at least one medical visit in each 6-month period of the 24-month measurement period, with a minimum of 60 between medical E:\FR\FM\23NOR3.SGM 23NOR3 Health Resources and Services Administration Resources and Services Administration ER23NO18.182</GPH> Process ! (Efficiency ) Physician Consortium for Performance Improvement Foundation (PCPI®) 60200 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.25. Infectious Disease ! (Appropriat e Use) BClaims Measure Specifications, MIPSCQMs Specifications Clinical Care Process 474 Specifications NIA MIPS CQMs Specifications Process Population Health Control and Prevention Community/ Population Health PPRNet Zoster (Shingles) Vaccination: The percentage of patients 50 years of age and older who have a Varicella Zoster vaccination. Patient 464 N/A MIPSCQMs Process Otitis Media with Effusion (OME): ! 0657 Safety, (Patient Specifications Systemic Antimicrobials- Avoidance of Efficiency, Safety) Inappropriate Use: and Cost Percentage of patients aged 2 months Reduction through 12 years with a diagnosis ofOME who were not prescribed systemic antimicrobials. We did not receive specific comments regarding the measures included in this specialty measure set. amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are VerDate Sep<11>2014 19:26 Nov 21, 2018 American Academy of Otolaryngology Head and Neck Surgery Foundation for the 2019 Performance Period and future Jkt 247001 PO 00000 Frm 00366 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.183</GPH> N/A v1 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60201 0069 065 CMS154 v7 eCQM Specifications, MIPS CQMs Specifications Process Efficiency and Cost Reduction Appropriate Treatment for Children with Upper Respiratory Infection (URI): Percentage of children 3 months--18 years of age who were diagnosed with upper respiratory infection (URI) and were not dispensed an antibiotic prescription on or 3 days after the episode National Committee for Quality Assurance N/A 066 CMS146 v7 eCQM Specifications, MIPS CQMs Specifications Process Efficiency and Cost Reduction Appropriate Testing for Children with Pharyngitis: Percentage of children 3-18 years of age who were diagnosed with pharyngitis, ordered an antibiotic and received a group A streptococcus (strep) test for the episode. National Committee for Quality Assurance 0653 091 N/A Medicare Part BClaims Measure Specifications, MIPS CQMs Specifications Process Effective Clinical Care Acute Otitis Externa (AOE): Topical Therapy: Percentage of patients aged 2 years and older with a diagnosis of AOE who were prescribed topical preparations. American Academy of Otolaryngology -Head and Neck Surgery VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00367 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 Most infectious disease physicians consult on patients in the inpatient setting. This measure applies to the outpatient setting and is reported by primary care, pediatricians, or other physicians to assess appropriate treatment for children with upper respiratory infections, hence this measure does not support the inpatient setting where the majority of eligible clinicians within this specialty practice. We agree with specialty society feedback that this measure is neither an applicable nor a clinically relevant quality measure to assess the clinical performance of Infectious Disease physicians only working within Most infectious disease physicians consult on patients in the inpatient setting. This measure applies to the outpatient setting and is reported by primary care, pediatricians, or other physicians to assess appropriate testing for children with pharyngitis, hence this measure does not support the inpatient setting where the majority of eligible clinicians within this specialty practice. We agree with specialty society feedback that this measure is neither an applicable nor a clinically relevant quality measure to assess the clinical performance of Infectious Disease physicians only working within ER23NO18.184</GPH> amozie on DSK3GDR082PROD with RULES3 B.25. Infectious Disease 60202 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.25. Infectious Disease BClaims Measure Specifications, MIPS CQMs Specifications and Cost Reduction Acute Otitis Externa (AOE): Systemic Antimicrobial TherapyAvoidance oflnappropriate Use: Percentage of patients aged 2 years and older with a diagnosis of AOE who were not prescribed systemic antimicrobial therapy. Surgery assess lan-nrrmriate topical therapy ltrt•ahne1nt for patients with otitis externa, hence this does not support the setting where the of eligible clinicians specialty practice. with specialty that this lpe:rfc,rm:an'"e oflnfectious physicians only within outpatient VerDate Sep<11>2014 116 N/A 19:26 Nov 21, 2018 MIPS CQMs Specifications Jkt 247001 Process PO 00000 Efficiency and Cost Reduction Frm 00368 Fmt 4701 Avoidance of Antibiotic Treatment in Adults with Acute Bronchitis: Percentage of adults 18-64 years of age with a diagnosis of acute bronchitis who were not dispensed an antibiotic prescription. Sfmt 4725 National Committee for Quality Assurance E:\FR\FM\23NOR3.SGM 23NOR3 physicians consult on patients in the inpatient setting. This measure applies to the outpatient setting and is reported by primary care, pediatricians, or other physicians to assess the appropriate use of antibiotics for patients with acute bronchitis, hence this measure does not support the inpatient setting where the majority of eligible clinicians within this specialty practice. We agree with specialty society feedback that this measure is neither an applicable nor a clinically relevant quality measure to assess the clinical performance of Infectious Disease ER23NO18.185</GPH> amozie on DSK3GDR082PROD with RULES3 0058 60203 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.25. Infectious Disease 0421 128 CMS69v 7 Medicare Part BClaims Measure Specifications, eCQM Specifications, CMS Web Interface Measure Specifications, MIPS CQMs Specifications Process Community /Population Health Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up Plan: Percentage of patients aged 18 years and older with a BMl documented during the current encounter or during the previous 12 months AND with a BMl outside of normal parameters, a follow-up plan is documented during the encounter or during the previous 12 months of the current encounter. Normal Parameters: Age 18 years and older BMl => 18.5 and < 25 kg/m2. Centers for Medicare & Medicaid Services We agree with specialty society feedback that this measure is neither an applicable nor a clinically relevant quality measure to assess the clinical performance of an Infectious Disease physician. This measure applies to the outpatient setting and is reported by primary care or other physicians as part of routine preventive care for patients. Most infectious disease physicians consult on patients in the inpatient setting. This measure does not support the inpatient setting where the majority of eligible clinicians within this NIA 176 NIA MIPSCQMs Specifications Process Effective Clinical Care Rheumatoid Arthritis (RA): Tuberculosis Screening: Percentage of patients aged 18 years and older with a diagnosis of rheumatoid arthritis (RA) who have documentation of a tuberculosis (TB) screening performed and results interpreted within 12 months prior to receiving a first course of therapy using a biologic disease-modifying anti-rheumatic drug (DMARD). American College of Rheumatology We agree with specialty society feedback that this measure is neither an applicable nor a clinically relevant quality measure to assess the clinical performance of an Infectious Disease physician. This measure applies to the outpatient setting and is reported by rheumatologists or other physicians as part of disease management for rheumatoid arthritis for patients. Most infectious disease physicians consult on patients in the inpatient setting. This measure does not support the inpatient setting where the majority of eligible clinicians within this 0028 226 CMS138 v7 Part B Claims Measure Specifications, eCQM Specifications, CMSWeb Interface Measure Specifications, MIPS CQMs Specifications Process VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Population Health Frm 00369 Fmt 4701 Sfmt 4725 Consortium for Performance Improvement Foundation (PCPI®) E:\FR\FM\23NOR3.SGM 23NOR3 . We agree society feedback that this measure is neither an applicable nor a clinically relevant quality measure to assess the clinical performance of an Infectious Disease physician. This measure applies to the outpatient setting and is reported by primary care or other physicians as part of preventive care for patients. Most infectious disease consult on ER23NO18.186</GPH> amozie on DSK3GDR082PROD with RULES3 . Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: a. Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months. b. Percentage of patients aged 18 years and older who were screened for tobacco use and identified as a tobacco user who received tobacco cessation 60204 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.25. Infectious Disease N/A 331 N/A amozie on DSK3GDR082PROD with RULES3 332 VerDate Sep<11>2014 19:26 Nov 21, 2018 Clinical Care MIPS CQMs Specifications Process MIPS CQMs Specifications Process Jkt 247001 PO 00000 Efficiency and Cost Reduction and Cost Reduction Frm 00370 Fmt 4701 patients in the inpatient setting. This measure does not support the inpatient setting where the majority of eligible clinicians within this specialty practice. Gastroentero logical Association Adult Sinusitis: Antibiotic Prescribed for Acute Sinusitis (Overuse): Percentage of patients, aged 18 years and older, with a diagnosis of acute sinusitis who were prescribed an antibiotic within 10 days after onset of symptoms. agree society feedback that this measure is neither an applicable nor a clinically relevant quality measure to assess the clinical performance of an Infectious Disease physician. This measure applies to the outpatient setting and is reported by gastroenterologists or other physicians as part of inflammatory bowel disease management. Most infectious disease physicians consult on patients in the inpatient setting. This measure does not support the inpatient setting where the majority of eligible clinicians within this physicians consult on patients in the inpatient setting. This measure applies to the outpatient setting and is reported by primary care, pediatricians, or other physicians to assess appropriate treatment for patients diagnosed with acute sinusitis, hence this measure does not support the inpatient setting where the majority of eligible clinicians within this specialty practice. We agree with specialty society feedback that this measure is neither an applicable nor a clinically relevant quality measure to assess the clinical performance of Infectious Disease physicians only working within Adult Sinusitis: Appropriate Choice of Antibiotic: Amoxicillin Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.187</GPH> Specifications intervention. c. Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user. Inflammatory Bowel Disease (IBD): Assessment of Hepatitis B Virus (HBV) Status Before Initiating Anti-TNF (Tumor Necrosis Factor) Therapy: Percentage of patients with a diagnosis of inflammatory bowel disease (IBD) who had Hepatitis B Virus (HB V) status assessed and results interpreted prior to initiating anti-TNF (tumor necrosis factor) therapy. Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60205 B.25. Infectious Disease N/A amozie on DSK3GDR082PROD with RULES3 N/A VerDate Sep<11>2014 333 334 N/A N/A 19:26 Nov 21, 2018 MIPS CQMs Specifications MIPS CQMs Specifications Jkt 247001 Efficiency Efficiency PO 00000 Efficiency and Cost Reduction Efficiency and Cost Reduction Frm 00371 Fmt 4701 Adult Sinusitis: Computerized Tomography (CT) for Acute Sinusitis (Overuse): Percentage of patients aged 18 years and older with a diagnosis of acute sinusitis who had a computerized tomography (CT) scan ofthe paranasal sinuses ordered at the time of diagnosis or received within 28 days after date of diagnosis. Adult Sinusitis: More than One Computerized Tomography (CT) Scan Within 90 Days for Chronic Sinusitis (Overuse): Percentage of patients aged 18 years and older with a diagnosis of chronic sinusitis who had more than one CT scan of the paranasal sinuses ordered or received within 90 days after the date of Sfmt 4725 American Academy of Otolaryngology Otolaryngology -Head and Neck Surgery American Academy of Otolaryngology Otolaryngology -Head and Neck Surgery E:\FR\FM\23NOR3.SGM 23NOR3 setting. This measure applies to the outpatient setting and is reported by primary care, pediatricians, or other physicians to assess appropriate treatment for patients diagnosed with acute sinusitis, hence this measure does not support the inpatient setting where the majority of eligible clinicians within this specialty practice. We agree with specialty society feedback that this measure is neither an applicable nor a clinically relevant quality measure to assess the clinical performance of Infectious Disease physicians only working within We agree with specialty society feedback that this measure is neither an applicable nor a clinically relevant quality measure to assess the clinical performance of an Infectious Disease physician. This measure applies to the outpatient setting and is reported by primary care, otolaryngologists, or other physicians to assess appropriate treatment for patients diagnosed with acute sinusitis. Most infectious disease physicians consult on patients in the inpatient setting. This measure does not support the inpatient setting where the majority of eligible clinicians within this This measure is being removed from the 2019 program based on the detailed rationale described below for this measure in "Table C: Quality Measures Finalized for Removal in the 2021 MIPS Payment Year and Future Years." ER23NO18.188</GPH> Clavulanate Prescribed for Patients with Acute Bacterial Sinusitis (Appropriate Use): Percentage of patients aged 18 years and older with a diagnosis of acute bacterial sinusitis that were prescribed amoxicillin, with or without clavulanate, as a first line antibiotic at the time of diagnosis. 60206 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.25. Infectious Disease N/A 387 N/A amozie on DSK3GDR082PROD with RULES3 390 VerDate Sep<11>2014 19:26 Nov 21, 2018 Clinical Care Prevention for Patients with Psoriasis, Psoriatic Arthritis and Rheumatoid Arthritis ou a Biological Immune Response Modifier : Percentage of patients, regardless of age, with Psoriasis, Psoriatic Arthritis and Rheumatoid Arthritis on a Biological Immune Response Modifier whose providers are ensuring active tuberculosis prevention either through yearly negative standard tuberculosis screening tests or are reviewing the patient's history to determine ifthey have had appropriate management for a recent or prior positive test. Academy of Dermatology society feedback that this measure is neither an applicable nor a clinically relevant quality measure to assess the clinical performance of an Infectious Disease physician. This measure applies to the outpatient setting and is reported by dermatologists, rheumatologists, or other physicians to ensure appropriate testing prior to treatment with a biological immune response modifier. . Most infectious disease physicians consult on patients in the inpatient setting. This measure does not support the inpatient setting where the majority of eligible clinicians within this Aunual Hepatitis C Virus (HCV) Screening for Patients who are Active Injection Drug Users: Percentage of patients, regardless of age, who are active injection drug users who received screening for HCV infection within the 12-month reporting period. Physician Consortium for Performance Improvement We agree with specialty society feedback that this measure is neither an applicable nor a clinically relevant quality measure to assess the clinical performance of an Infectious Disease physician. This measure applies to the outpatient setting and is reported by primary care or other physicians as part of screening process for a high risk patient population. Most infectious disease physicians consult on patients in the inpatient setting. This measure does not support the inpatient setting where the majority of eligible clinicians within this MIPSCQMs Specifications Process Effective Clinical Care MIPS CQMs Specifications Process Person CaregiverCentered Experience and Outcomes Jkt 247001 PO 00000 Frm 00372 Fmt 4701 Hepatitis C: Discussion and Shared Decision Making Surrounding Treatment Options: Percentage of patients aged 18 years and older with a diagnosis of hepatitis C with whom a physician or other qualified healthcare professional reviewed the range of treatment options appropriate to their genotype and demonstrated a shared decision making approach with the Sfmt 4725 Gastroenterolog ical Association E:\FR\FM\23NOR3.SGM 23NOR3 We agree society feedback that this measure is neither an applicable nor a clinically relevant quality measure to assess the clinical performance of an Infectious Disease physician. This measure applies to the outpatient setting and is reported by primary care, gastroenterologists, or other physicians to promote shared decision making with with C. ER23NO18.189</GPH> Specifications 60207 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.25. Infectious Disease 394 N!A 400 MIPSCQMs Specifications Process MIPS CQMs Specifications Process MIPSCQMs Specifications Process Community /Population Health Clinical Care One-Time Screening for Hepatitis C Virus (HCV) for Patients at Risk: Percentage of patients aged 18 years and older with one or more of the following: a history of injection drug use, receipt of a blood transfusion prior to 1992, receiving maintenance hemodialysis OR birthdate in the years 1945-1965 who received onetime screening for hepatitis C virus (HCV) infection. Most infectious disease physicians consult on patients in the inpatient setting. This measure does not support the inpatient setting where the majority of eligible clinicians within this specialty practice. National Committee for Quality Assurance Consortium for Performance Improvement Foundation (PCPI®) We agree with specialty society feedback that this measure is neither an applicable nor a clinically relevant quality measure to assess the clinical performance of an Infectious Disease physician. This measure applies to the outpatient setting and is reported by primary care, pediatricians, or other physicians as part of well child care for patients. Most infectious disease physicians consult on patients in the inpatient setting. This measure does not support the inpatient setting where the majority of eligible clinicians within this We agree society feedback that this measure is neither an applicable nor a clinically relevant quality measure to assess the clinical performance of an Infectious Disease physician. This measure applies to the outpatient setting and is reported by primary care or other physicians to assess the appropriate screening for a high-risk patient population. Most infectious disease physicians consult on patients in the inpatient setting. This measure does not support the inpatient setting where the majority of eligible clinicians within this . amozie on DSK3GDR082PROD with RULES3 401 VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00373 Hepatitis C: Screening for Hepatocellular Carcinoma in Patients with Fmt 4701 Sfmt 4725 . Gastroenterolog ica1 Association E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.190</GPH> 1407 To meet the measure, there must be documentation in the patient record of a discussion between the physician or other qualified healthcare professional and the patient that includes all of the following: treatment choices appropriate to genotype, risks and benefits, evidence of effectiveness, and patient toward treatment. Immunizations for Adolescents: The percentage of adolescents 13 years of age who had the recommended immunizations by their 13th birthday. 60208 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.25. Infectious Disease applicable nor a clinically relevant quality measure to assess the clinical performance of an Infectious Disease physician. This measure applies to the outpatient setting and is reported by primary care, gastroenterologists, or other physicians to ensure appropriate screening for patients with cirrhosis. Most infectious disease physicians consult on patients in the inpatient setting. This measure does not support the inpatient setting where the majority of eligible clinicians within this Cirrhosis: Percentage of patients aged 18 years and older with a diagnosis of chronic hepatitis C cirrhosis who underwent imaging with either ultrasound, contrast enhanced CT or MRI for hepatocellular carcinoma (HCC) at least once within the 12-month submission period. N/A 447 N/A MIPS CQMs Specifications Process Community I Population Health Chlamydia Screening and Follow Up: The percentage of female adolescents 16 years of age who had a chlamydia screening test with proper follow-up during the measurement period. National Committee for Quality Assurance This measure is being removed from the 2019 program based on the detailed rationale described below for this measure in "Table C: Quality Measures Finalized for Removal in the 2021 MIPS Payment Year , Comment: One commenter supported removing measure Q065: Appropriate Treatment for Children with Upper Respiratory Infection, Appropriate Testing for Children with Pharyngitis and Avoidance of Antibiotic Treatment in Adults with Acute Bronchitis from the Infectious Disease set. That set focuses on acute care while these measures focus on primary care. Response: We thank the commenter for their support on removal of this measure. Comment: One commenter noted that there will be a negative impact from the removal of measures Q 130 and Q226 on quality reporting for Infectious Disease specialists and across all eligible medical specialties. They noted that according to the 2016 PQRS Experience Report the 41 MD/DO specialties listed in Table 14: Top Reported Individual Measures by Specialty or Provider Type (2016) in the 2016 PQRS Experience Report, Ql30 was the top measure reported by 29 specialties (70 percent) and Q226 was reported the second most by 21 specialties (51 percent). In addition, across all medical specialties claims-based reporting was the most utilized method of reporting for the 2016 PQRS program. With the above rationale, the commenter asked CMS to consider retaining measure Q130 and Q226 as they would not only affect the opportunities to report for Infectious Disease physicians but most of medical specialties. Response: To clarify, measure Q130 was not proposed for removal from the Infectious Disease specialty measure set nor from the 2019 Quality Payment Program as a whole, and therefore, will be retained for reporting. Also to clarify further, Q226 was not proposed for removal from the program in general but only proposed to be removed from the Infectious Disease specialty measure set. While we agree that Q226 is a highly reported measure that is applicable to many eligible clinicians, we received specific feedback from specialty societies that this measure was not applicable to most infectious disease physicians as they mostly consult in an inpatient setting. Q226 is specific to the outpatient setting and therefore would not be applicable to most infectious disease physicians. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00374 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.191</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are finalizing the removal of measures from the Infectious Disease Specialty Measure Set as proposed for the 2019 Performance Period and future 60209 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.26. Neurosurgical In addition to the considerations discussed in the introductory language of Table Bin this final rule, the Neurosurgical specialty set takes into consideration the following criteria, which includes, but is not limited to: the measure reflects current clinical guidelines and the coding of the measure includes the specialists. We may reassess the appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. This measure set does not have any measures removed from prior years. B.26. Neurosurgical Measure Specifications, MIPS CQMs Specifications ! (Patient Safety) ! (Patient Safety) amozie on DSK3GDR082PROD with RULES3 § VerDate Sep<11>2014 Part BClaims Measure Specifications, MIPS CQMs Specifications Process 0419 130 CMS68v 8 Medicare Part B Claims Measure Specifications, eCQM Specifications, MIPS CQMs Specifications Process Patient Safety N/A 187 N/A MIPS CQMs Specifications Process Effective Clinical Care 0028 226 CMS138 v7 Medicare Part BClaims Measure Specifications, eCQM Specifications, CMSWeb Interface Measure Specifications, MIPS CQMs Specifications Process Community/ Population Health Jkt 247001 PO 00000 19:26 Nov 21, 2018 Frm 00375 Fmt 4701 Sfmt 4725 Perioperative Care: Selection of Prophylactic Antibiotic - First OR Second Generation Cephalosporin: Percentage of surgical patients aged 18 years and older undergoing procedures with the indications a first OR second generation cephalosporin prophylactic antibiotic, who had an order for a first OR second generation cephalosporin for antimicrobial Perioperative Care: Venous Thromboembolism (VTE) Prophylaxis (When Indicated in ALL Patients): Percentage of surgical patients aged 18 years and older undergoing procedures for which venous thromboembolism (VTE) prophylaxis is indicated all patients, who had an order for Low Molecular Weight Heparin (LMWH), Low-Dose Unfractionated Heparin (LDUH), adjusted-dose warfarin, fondaparinux or mechanical prophylaxis be given within 24 hours prior to incision time or within 24 hours after end time. Documentation of Current Medications in the Medical Record: Percentage of visits for patients aged 18 years and older for which the eligible professional or eligible clinician attests to documenting a list of current medications using all immediate resources on the date of the encounter. This list must include ALL known prescriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutritional) supplements AND must contain the medications' name, dosage, frequency and route of Stroke and Stroke Rehabilitation: Thrombolytic Therapy: Percentage of patients aged 18 years and older with a diagnosis of acute ischemic stroke who arrive at the hospital within 2 hours of time last known well and for whom IV t-PA was initiated within 3 hours of time last known well. Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: a. Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months. b. Percentage of patients aged 18 years and older who were screened for tobacco use and identified as a tobacco user who received tobacco cessation intervention. c. Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user. E:\FR\FM\23NOR3.SGM 23NOR3 Surgeons Society of Plastic Surgeons Centers for Medicare & Medicaid Services American Association Consortium Performance Improvement Foundation (PCPI®) ER23NO18.192</GPH> ! (Patient Safety) 60210 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.26. Neurosurgical 345 N/A MIPS CQMs Specifications Outcome Effective Clinical Care ! (Outcome ) 1540 346 N/A MIPS CQMs Specifications Outcome Effective Clinical Care ! (Outcome ) Specifications N/A 413 N/A (Outcome ) MIPS CQMs Specifications te Outcome Effective Clinical Care * N/A 459 N/A MIPS CQMs Specifications Patient Reported Outcome Person and CaregiverCentered Experience and Outcomes * N/A 460 N/A MIPS CQMs Specifications Patient Reported Outcome Person and CaregiverCentered ! (Outcome ) (Outcome ) MIPS CQMs Specifications ! (Outcome ) ! (Patient Experienc e) amozie on DSK3GDR082PROD with RULES3 Clinical Care Experience and Outcomes 2643 469 N/A MIPS CQMs Specifications ! (Patient Experienc e) MIPS CQMs Specifications ! (Patient Experienc e) MIPS CQMs Specifications VerDate Sep<11>2014 Reported Outcome 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Patient Reported Outcome Person and CaregiverCentered Experience and Outcomes Reported Outcome CaregiverCentered Experience and Outcomes Reported Outcome CaregiverCentered Experience and Outcomes Frm 00376 Fmt 4701 Sfmt 4725 Rate of Asymptomatic Patients Undergoing Carotid Artery Stenting (CAS) Who Are Stroke Free or Discharged Alive: Percent of asymptomatic patients undergoing CAS who are stroke free while in the hospital or discharged alive Rate of Asymptomatic Patients Undergoing Carotid Endarterectomy (CEA) Who Are Stroke Free or Discharged Alive: Percent of asymptomatic patients undergoing CEA who are stroke free or alive Society for Vascular Surgeons Treatment: Percentage of patients with a mRs score of 0 to 2 at 90 days following endovascular stroke intervention. Door to Puncture Time for Endovascular Stroke Treatment: Percentage of patients undergoing endovascular stroke treatment who have a door to puncture time ofless than 2 hours. Average Change in Back Pain Following Lumbar Discectomy and/or Laminotomy: The average change (preoperative to 3 months postoperative) in back pain for patients 18 years of age or older who had lumbar discectomy Interventional Radiology Average Change in Back Pain Following Lumbar Fusion: The average change (preoperative to 1 year postoperative) in back pain for patients 18 years of age or older who had lumbar fusion Average Change in Leg Pain Following Discectomy and/or Laminotomy: The average change (preoperative to 3 months postoperative) in leg pain for patients 18 years of age or older who had lumbar discectomy MN Community Measurement Average Change in Functional Status Following Lumbar Spine Fusion Surgery: For patients aged 18 and older undergoing lumbar spine fusion surgery, the average change from preoperative functional status to 1 year (9 to 15 post-operative functional status using the Disability Index (ODI version 2.la) patient outcome tool. Average Change in Functional Status Following Lumbar Discectomy Laminotomy Surgery: For patients aged 18 and older undergoing lumbar discectomy laminotomy surgery, the average change from pre-operative functional status to 3 months (6 to 20 weeks) post-operative functional status using the Oswestry Disability Index (ODI version 2. outcome tool. Average Change in Leg Pain Following Spine Fusion Surgery: For patients aged 18 and older undergoing lumbar spine fusion surgery, the average change from preoperative leg pain to 1 year (9 to 15 months) postoperative leg pain using the Visual Analog Scale outcome tool. Minnesota Community Measurement E:\FR\FM\23NOR3.SGM 23NOR3 Society for Vascular Surgeons Society of Interventional Radiology MN Community Measurement MN Community Measurement Community Measurement Community Measurement ER23NO18.193</GPH> 1543 (Outcome ) Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60211 B.26. Neurosurgical Comment: One commenter requested for measure Q023: Perioperative Care: Venous Thromboembolism (VTE) Prophylaxis (When Indicated in ALL Patients) that the measure be changed to exclude unicompartmental!partial knee replacement in the denominator until the developer can consider the inclusion of ASA for acceptable prophylaxis consistent with current guidelines. Response: We agree that the measure should align with current clinical guidelines. We will provide this suggestion to the measure steward for future consideration in the annual updates of the measure specifications. Comment: One commenter supported measure Ql87: Stroke and Stroke Rehabilitation: Thrombolytic Therapy in this measure set. The commenter encouraged CMS to continue to consider measurement and payment of high quality, cost effective stroke care in all settings, including in the hospital inpatient setting. Response: We thank the commenter for their support of measure Ql87: Stroke and Stroke Rehabilitation: Thrombolytic Therapy. Comment: Once commenter expressed concern about the following new measures in this measure set: Q469: Average Change in Functional Status Following Lumbar Spine Fusion Surgery; Q471: Average Change in Functional Status Following Lumbar Discectomy Laminotomy Surgery; and Q473: Average Change in Leg Pain Following Lumbar Spine Fusion Surgery. Although the commenter supported the measures in concept, they noted that the measures require the use of specific tools to capture pain (that is, Visual Analog Scale or VAS) and functional status (that is, Oswestry Disability Index or ODI) despite the existence of equally useful scoring systems. The commenter also noted these measures should provide more flexibility to clinicians by instead focusing more generically on "improvement on a validated pain or disability patient-reported outcome tool." The commenter further expressed concern that they were never consulted about the appropriateness of these measures and would have appreciated an earlier opportunity to provide feedback. Response: The measure steward has developed and tested these measures using the VAS and ODI tools to assess the change in status. We do not own this measure and encourage the commenter to collaborate with the measure steward to expand the assessment tools. With regard to concerns about measure selection input for this specialty set, prior to rulemaking we solicit feedback from stakeholders with regards to measures that should be added or removed to existing specialty sets or the development of new specialty sets. We ask the commenter to submit their feedback during this solicitation process for future consideration in rulemaking. VerDate Sep<11>2014 19:26 Nov 21, 2018 for the 2019 Performance Period and future Jkt 247001 PO 00000 Frm 00377 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.194</GPH> amozie on DSK3GDR082PROD with RULES3 FINALACTION: Weare 60212 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.27. Podiatry In addition to the considerations discussed in the introductory language of Table Bin this final rule, the Podiatry specialty set takes into consideration the following criteria, which includes, but is not limited to: the measure reflects current clinical guidelines and the coding of the measure includes the specialists. We may reassess the appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. This measure set does not have any measures removed from prior years. B.27. Podiatry 0416 127 N/A MIPSCQMs Specifications Process Effective Clinical Care * 0421 128 CMS69v 7 Medicare Part B Claims Measure Specifications, eCQM Specifications, MIPSCQMs Specifications Process Community/ Population Health ! (Patient Safety) 0101 154 N/A Medicare Part BClaims Measure Specifications, MIPSCQMs Process Patient Safety ! (Care Coordinat ion) 0101 155 Part Process § 0028 226 CMS138 v7 Medicare Part BCiaims Measure Specifications, eCQM Specifications, CMS Web Interface Measure Specifications MIPSCQMs Specifications Process Community/ Population Health 0101 318 CMS139 v7 eCQM Specifications, CMS Web Interface Measure Process Patient Safety Jkt 247001 PO 00000 amozie on DSK3GDR082PROD with RULES3 § VerDate Sep<11>2014 tion and Care Coordinatio n 19:26 Nov 21, 2018 Frm 00378 Fmt 4701 Sfmt 4725 Care, Peripheral Neuropathy -Neurological Evaluation: Percentage of patients aged 18 years and older with a diagnosis of diabetes mellitus who had a neurological examination of their lower extremities within 12 months. Diabetes Mellitus: Diabetic Foot and Ankle Care, Ulcer Prevention- Evaluation of Footwear: Percentage of patients aged 18 years and older with a diagnosis of diabetes mellitus who were evaluated for footwear and Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up Plan: Percentage of patients aged 18 years and older with a BMI documented during the current encounter or during the previous 12 months AND with a BMI outside of normal parameters, a follow-up plan is documented during the encounter or during the previous 12 months of the current encounter. Normal Parameters: Age 18 years and older BMI => 18.5 and< 25 Falls: Risk Assessment: Percentage of patients aged 65 years and older with a history of falls who had a risk assessment for falls completed within 12 months. Podiatric Medical Association American Podiatric Medical Association Centers for Medicare& Medicaid Services Falls: Plan of Care: Percentage of patients aged 65 years and older with a history of falls who had a plan of care for falls documented within 12 months. Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: a. Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months. b. Percentage of patients aged 18 years and older who were screened for tobacco use and identified as a tobacco user who received tobacco cessation intervention. c. Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user. Falls: Screening for Future Fall Risk: Percentage of patients 65 years of age and older who were screened for future fall risk during the measurement period. E:\FR\FM\23NOR3.SGM 23NOR3 Physician Consortium for Performance Improvement Foundation (PCPI®) Committee Quality Assurance ER23NO18.195</GPH> Clinical Care Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60213 B.27. Podiatry We did not receive specific comments regarding the measures included in this specialty measure set. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00379 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.196</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are finalizing the Podiatry Specialty Measure Set as proposed for the 2019 Performance Period and future years with the exception of the newly proposed composite measure: Falls: Screening, Risk-Assessment, and Plan of Care to Prevent Future Falls. We are no longer finalizing the inclusion of the composite falls measure because it must be fully vetted to utilize standardized tools that would appropriately identify the at-risk patient population. In addition, as noted in our responses to public comments in Table C, measures Ql54, Ql55, and Q318 are not finalized for removal from this measure set as proposed; therefore, will be retained in this measure set for the 2019 Performance Period and future 60214 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.28. Rheumatology In addition to the considerations discussed in the introductory language of Table B in this final rule, the Rheumatology specialty set takes into consideration the following criteria, which includes, but is not limited to: the measure reflects current clinical guidelines and the coding of the measure includes the specialists. We may reassess the appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. This measure set does not have any measures removed from prior years. B.28. Rheumatology ! (Care Coordinat ion) Measure Specifications, MIPS CQMs Specifications 0046 039 N/A Part B Claims Measure Specifications, MIPS CQMs Process Effective Clinical Care 0326 047 N/A Part B Claims Measure Specifications, MIPS CQMs Specifications Process Communicat ion and Care Coordination PartB Measure Specifications, eCQM Specifications, Web Interface Measure Specifications, MIPS CQMs Process 0041 * 110 amozie on DSK3GDR082PROD with RULES3 CMS147 v8 N/A Ill CMS127 v7 0421 128 CMS69v 7 § VerDate Sep<11>2014 ion and Care Coordination 19:26 Nov 21, 2018 Jkt 247001 Part B Claims Measure Specifications, eCQM Specifications, MIPS CQMs Specifications PO 00000 Population Health Communication with the Physician or Other Clinician Managing On-going Care PostFracture for Men and Women Aged 50 Years and Older: Percentage of patients aged 50 years and older treated for a fracture with documentation of communication, between the physician treating the fracture and the physician or other clinician managing the patient's on-going care, that a fracture occurred and that the patient was or should be considered for osteoporosis treatment or testing. This measure is reported by the physician who treats the fracture and who therefore is held accountable National Committee for Quality Assurance Percentage of patients aged 65 years and older who have an advance care plan or surrogate decision maker documented in the medical record or documentation in the medical record that an advance care plan was discussed but the patient did not wish or was not able to name a surrogate decision maker an advance care Preventive Care and Screening: Influenza Immunization: Percentage of patients aged 6 months and older seen for a visit between October I and March 31 who received an influenza immunization OR who reported previous receipt of an influenza immunization. Process Community/ Population Health Pneumococcal Vaccination Status for Older Adults: Percentage of patients 65 years of age and older who have ever received a pneumococcal vaccine. Process Community/ Population Health Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up Plan: Percentage of patients aged 18 years and older with a BMI documented during the current encounter or during the previous 12 months AND with a BMI outside of normal parameters, a follow-up plan is documented during the encounter or during the previous 12 months of the current encounter. Normal Parameters: Age 18 years and older BMI => 18.5 and< 25 Frm 00380 Fmt 4701 Sfmt 4725 Committee for Quality Assurance E:\FR\FM\23NOR3.SGM 23NOR3 National Committee for Quality Assurance Consortium for Performance Improvement Foundation (PCPI®) Centers for Medicare& Medicaid Services ER23NO18.197</GPH> (Care Coordinat ion) Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60215 B.28. Rheumatology 0419 130 CMS68v 8 Part B Claims Measure Specifications, eCQM Specifications, MIPS CQMs Specifications Process Patient Safety 0420 131 N/A Part B Claims Measure Specifications, MIPS CQMs Specifications Process Communicati on and Care Coordination * N/A 176 N/A MIPS CQMs Specifications Process Effective Clinical Care Rheumatoid Arthritis (RA): Tuberculosis Screening: Percentage of patients aged 18 years and older with a diagnosis of rheumatoid arthritis (RA) who have documentation of a tuberculosis (TB) screening performed and results interpreted within 12 months prior to receiving a first course of therapy using a biologic disease-modizying anti-rheumatic drug American College of * N/A 177 N/A MIPS CQMs Specifications Process Effective Clinical Care American College of N/A 178 N/A MIPS CQMs Specifications Process Effective Clinical Care N/A 179 N/A MIPS CQMs Specifications Process Effective Clinical Care Rheumatoid Arthritis (RA): Periodic Assessment of Disease Activity: Percentage of patients aged 18 years and older with a diagnosis of rheumatoid arthritis (RA) who have an assessment of disease activity at 2:50 percent of encounters for RA for each patient during the measurement Rheumatoid Arthritis (RA): Functional Status Assessment: Percentage of patients aged 18 years and older with a diagnosis of rheumatoid arthritis (RA) for whom a functional status assessment was performed at least once within 12 months. Rheumatoid Arthritis (RA): Assessment and Classification of Disease Prognosis: Percentage of patients aged 18 years and older with a diagnosis of rheumatoid arthritis (RA) who have an assessment and classification of disease N/A 180 N/A MIPS CQMs Specifications Process Effective Clinical Care 0028 226 CMS138 v7 Part B Claims Measure Specifications, eCQM Specifications, Web Interface Measure Process Community/ Population Health ! (Care Coordinat ion) amozie on DSK3GDR082PROD with RULES3 § VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00381 Fmt 4701 Sfmt 4725 Documentation of Current Medications in the Medical Record: Percentage of visits for patients aged 18 years and older for which the eligible professional or eligible clinician attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list must include ALL known prescriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutritional) supplements AND must contain the medications' name, dosage, and route of administration. Pain Assessment and Follow-Up: Percentage of visits for patients aged 18 years and older with documentation of a pain assessment using a standardized tool(s) on each visit AND documentation of a follow-up plan when pain is Rheumatoid Arthritis (RA): Glucocorticoid Management: Percentage of patients aged 18 years and older with a diagnosis of rheumatoid arthritis (RA) who have been assessed for glucocorticoid use and, for those on prolonged doses of prednisone 2: 10 mg daily (or equivalent) with improvement or no change in disease activity, documentation of glucocorticoid within 12 months. Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: a. Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months. b. Percentage of patients aged 18 years and older who were screened for tobacco use and identified as a tobacco user who received tobacco cessation E:\FR\FM\23NOR3.SGM 23NOR3 Centers for Medicare& Medicaid Services Centers for Medicare& Medicaid Services American College of American College of Physician Consortium for Performance Improvement Foundation (PCP!®) ER23NO18.198</GPH> ! (Patient Safety) 60216 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.28. Rheumatology MIPS CQMs Specifications 0018 236 II (Outcome ) I (Patient Safety) I (Care Coordinat ion) CMS165 v7 Part B Claims Measure Specifications, eCQM Specifications, Web Interface Measure Specifications, MIPS CQMs Intermediat Effective e Outcome Clinical Care intervention. c. Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user. Controlling High Blood Pressure: Percentage of patients 18-85 years of age who had a diagnosis of hypertension and whose blood pressure was adequately controlled (<140/90mmHg) during the measurement period Committee Quality Assurance 0022 238 CMS156 v7 eCQM Specifications, MIPS CQMs Specifications Process Patient Safety Use of High-Risk Medications in the Elderly: Percentage of patients 6565 years of age and older who were ordered high-risk medications. Two rates are reported. a. Percentage of patients who were ordered at least one high-risk medication. b. Percentage of patients who were ordered at least N/A 317 CMS22v 7 Part B Claims Measure Specifications, eCQM Specifications, MIPS CQMs Specifications Process Community/ Population Health Preventive Care and Screening: Screening for High Blood Pressure and Follow-Up Documented: Percentage of patients aged 18 years and older seen during the reporting period who were screened for high blood pressure AND a recommended follow-up plan is documented based on the current blood Centers for Medicare& Medicaid Services N/A 374 CMS50v 7 eCQM Specifications, MIPS CQMs Specifications Process Communicat ion and Care Coordination Centers for Medicare& Medicaid Services MIPS CQMs Specifications Process Closing the Referral Loop: Receipt of Specialist Report: Percentage of patients with referrals, regardless of age, for which the referring provider receives a report from the provider to whom the patient was referred. Tobacco Use and Help with Quitting Among Adolescents: The percentage of adolescents 12 to 20 years of age with a primary care visit during the measurement year for whom tobacco use status was documented and received help with quitting if identified as a tobacco user. Population Health measure set. VerDate Sep<11>2014 19:26 Nov 21, 2018 for the 2019 Performance Period and Jkt 247001 PO 00000 Frm 00382 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.199</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: Weare 60217 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.29. Physical Therapy/Occupational Therapy In addition to the considerations discussed in the introductory language of Table Bin this final rule, the Physical Therapy/Occupational Therapy specialty set takes into consideration the following criteria, which includes, but is not limited to: the measure reflects current clinical guidelines and the coding of the measure includes the specialists. We may reassess the appropriateness of individual measures, on a case-by -case basis, to ensure appropriate inclusion in the specialty set. This is a new specialty set for 2019; therefore, we are not removing any measures from this specialty set. B.29. Physical Therapy/Occupational Therapy 0421 128 CMS69v 7 Medicare Part BClaims Measure Specifications, eCQM Specifications, MIPSCQMs Specifications Process Community/Po pulation Health ! (Patient Safety) 0419 130 CMS68v 8 Medicare Part BClaims Measure Specifications, eCQM Specifications, MIPSCQMs Specifications Process Patient Safety ! (Care Coordinat ion) 0420 131 N/A Medicare Part BClaims Measure Specifications, MIPSCQMs Process Communication and Care Coordination ! (Care Coordinat ion) 2624 182 Part BClaims Measure Specifications, MIPSCQMs Specifications Process MIPSCQMs Specifications Patient Reported Outcome 0422 217 N/A (Outcome ) and Care Coordination Communication and Care Coordination amozie on DSK3GDR082PROD with RULES3 * VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00383 Fmt 4701 Sfmt 4725 Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up Plan: Percentage of patients aged 18 years and older with a BMl documented during the current encounter or during the previous 12 months AND with a BMI outside of normal parameters, a follow-up plan is documented during the encounter or during the previous 12 months of the current encounter. Normal Parameters: Age 18 years and older BMI> Documentation of Current Medications in the Medical Record: Percentage of visits for patients aged 18 years and older for which the eligible professional or eligible clinician attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list must include ALL known prescriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutritional) supplements AND must contain the medications' name, dosage, frequency and Centers for Medicare& Medicaid Services Centers for Medicare& Medicaid Services Centers for Medicare& Medicaid Services Functional Outcome Assessment: Percentage of visits for patients aged 18 years and older with documentation of a current functional outcome assessment using a standardized functional outcome assessment tool on the date of the encounter AND documentation of a care plan based on identified functional outcome deficiencies on Centers Medicare& Medicaid Services Functional Status Change for Patients with Knee Impairments: A patient-reported outcome measure of riskadjusted change in functional status for patients aged 14 years+ with knee impairments. The change in functional status (FS) is assessed using the Knee FS patientreported outcome measure (PROM) (©Focus on Therapeutic Outcomes, Inc.). The measure is adjusted to patient characteristics known to be associated with FS outcomes (risk adjusted) and used as a performance measure at the patient level, at the individual clinician, and at the clinic level to assess The measure Focus on Therapeutic Outcomes, Inc. E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.200</GPH> * § 60218 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.29. Physical Therapy/Occupational Therapy Specifications Reported Outcome and Care Coordination * ! (Outcome ) 0424 219 N/A MIPSCQMs Specifications Patient Reported Outcome Communication and Care Coordination 0425 220 N/A MIPSCQMs Specifications Patient Reported Outcome Communication and Care Coordination 0426 221 N/A MIPSCQMs Specifications Patient Reported Outcome Communication and Care Coordination * ! (Outcome ) * ! (Outcome ) amozie on DSK3GDR082PROD with RULES3 * VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00384 Fmt 4701 Sfmt 4725 Functional Status Change for Patients with Hip Impairments: A patient-reported outcome measure of riskadjusted change in functional status for patients 14 years+ with hip impairments. The change in functional status (FS) is assessed using the Hip FS patient-reported outcome measure (PROM) (©Focus on Therapeutic Outcomes, Inc.). The measure is adjusted to patient characteristics known to be associated with FS outcomes (risk adjusted) and used as a performance measure at the patient level, at the individual clinician, and at the clinic level to assess quality. The measure is available as a computer adaptive test, for reduced patient or a short form Functional Status Change for Patients with Lower Leg, Foot or Ankle Impairments: A patient-reported outcome measure of riskadjusted change in functional status for patients 14 years+ with foot, ankle and lower leg impairments. The change in functional status (FS) assessed using the Foot/Ankle FS patient-reported outcome measure (PROM) (©Focus on Therapeutic Outcomes, Inc.). The measure is adjusted to patient characteristics known to be associated with FS outcomes (risk adjusted) and used as a performance measure at the patient level, at the individual clinician, and at the clinic level to assess quality. The measure is available as a computer adaptive test, for reduced patient burden, or a short form Functional Status Change for Patients with Low Back Impairments: A patient-reported outcome measure of riskadjusted change in functional status for patients 14 years+ with low back impairments. The change in functional status (FS) is assessed using the Low Back FS patientreported outcome measure (PROM) (©Focus on Therapeutic Outcomes, Inc.). The measure is adjusted to patient characteristics known to be associated with FS outcomes (risk adjusted) and used as a performance measure at the patient level, at the individual clinician, and at the clinic level by to assess quality. The measure is available as a computer adaptive test, for reduced patient burden, or a short form Functional Status Change for Patients with Shoulder Impairments: A patient-reported outcome measure of riskadjusted change in functional status for patients 14 years+ with shoulder impairments. The change in functional status (FS) is assessed using the Shoulder FS patientreported outcome measure (PROM) (©Focus on The measure E:\FR\FM\23NOR3.SGM 23NOR3 Focus on Therapeutic Outcomes, Inc. Focus on Therapeutic Outcomes, Inc. Focus on Therapeutic Outcomes, Inc. Focus on Therapeutic Outcomes, Inc. ER23NO18.201</GPH> (Outcome ) Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60219 B.29. Physical Therapy/Occupational Therapy to be associated with FS outcomes (risk adjusted) and used as a performance measure at the patient level, at the individual clinician, and at the clinic level to assess quality. The measure is available as a computer adaptive test, for reduced patient burden, or a short form (static 0427 222 MIPSCQMs Specifications (Outcome ) Functional Status Change for Patients with Elbow, Wrist or Hand Impairments: A patient-reported outcome measure of riskadjusted change in functional status (FS) for patients 14 years+ with elbow, wrist or hand impairments. The change in FS is assessed using the Elbow/Wrist/Hand FS patientreported outcome measure (PROM) (©Focus on Therapeutic Outcomes, Inc.) The measure is adjusted to patient characteristics known to be associated with FS outcomes (risk adjusted) and used as a performance measure at the patient level, at the individual clinician, and at the clinic level to assess quality. The measure is available as a computer adaptive test, for reduced patient burden, or a short form (static Reported Outcome and Care Coordination Patient Reported Outcome Communication and Care Coordination * ! (Outcome ) Focus on Therapeutic Outcomes, Inc. Focus on Functional Status Change for Patients with Therapeutic General Orthopedic Impairments: A patient-reported outcome measure of riskOutcomes, adjusted change in functional status (FS) for Inc. * patients aged 14 years+ with general orthopedic impairments (neck, cranium, mandible, thoracic spine, ribs or other general orthopedic impairment). The change in FS is assessed using the General Orthopedic FS PROM (patient reported outcome measure) (©Focus on Therapeutic Outcomes, Inc.). The measure is adjusted to patient characteristics known to be associated with FS outcomes (risk adjusted) and used as a performance measure at the patient level, at the individual clinician, and at the clinic level to assess quality. The measure is available as a computer adaptive test, for reduced patient burden, or a short form Comment: One commenter supported the creation of the Physical and Occupational Therapy Specialty Measure Set. The commenter encouraged CMS to make two additional measures available to physical therapists (Q126 Diabetic Foot and Ankle Care, Peripheral Neuropathy: Neurological Evaluation; and Q127 Diabetic Foot and Ankle Care, Ulcer Prevention Evaluation of Footwear) and three additional measures available to occupational therapists (Q134 Screening for Depression and Follow-Up Plan); Q181 Elder Maltreatment Screen and Follow-Up Plan); and Q226 Tobacco Use: Screening and Cessation Intervention). 0428 223 N/A MIPSCQMs Specifications Response: We will provide this recommendation to the measure steward for measures Q126 Diabetic Foot and Ankle Care, Peripheral Neuropathy: Neurological Evaluation, Q127 Diabetic Foot and Ankle Care, Ulcer Prevention Evaluation of Footwear, and Q226 Tobacco Use: Screening and Cessation Intervention. We will evaluate the commenter's request for inclusion for future revisions for measures Q134 Screening for Depression and Follow-Up Plan, Q181 Elder Maltreatment Screen and Follow-Up Plan. We maintain that the measures are still valid as currently specified which includes many clinical settings, but will thoroughly vet the request to include physical and occupational therapy. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00385 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.202</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are finalizing the Physical Therapy/Occupational Therapy Specialty Measure Set as proposed for the 2019 Performance Period and future years with the exception of the newly proposed composite measure: Falls: Screening, Risk-Assessment, and Plan of Care to Prevent Future Falls. We are no longer finalizing the inclusion of the composite falls measure because it must be fully vetted to utilize standardized tools that would appropriately identify the at-risk patient 60220 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.30. Geriatrics In addition to the considerations discussed in the introductory language of Table Bin this final rule, the Geriatrics specialty set takes into consideration the following criteria, which includes, but is not limited to: the measure reflects current clinical guidelines and the coding of the measure includes the specialists. We may reassess the appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. This is a new specialty set for 2019; therefore, we are not removing any measures from this specialty set. B.30. Geriatrics Screening for Osteoporosis for Women Aged 65-85 Years of Age: Percentage of female patients aged 65-85 years of age who ever had a central dual-energy X-ray absorptiometry (DXA) to check for osteoporosis. § ! (Care Coordinat ion) 0097 046 N/A Medicare Part BCiaims Measure Specifications, MIPSCQMs Specifications Process Communication and Care Coordination 0326 047 N/A Medicare Part BCiaims Measure Specifications, MIPSCQMs Specifications Process Communication and Care Coordination N/A 050 N/A Medicare Part BClaims Measure Specifications, MIPSCQMs Specifications Process Person and CaregiverCentered Experience and Outcomes 7v8 BClaims Measure Specifications, eCQM Specifications, CMS Web Interface Measure Specifications, MIPSCQMs CMS12 7v7 Medicare Part BClaims Measure * (Care Coordinat ion) ! (Patient Experienc e) amozie on DSK3GDR082PROD with RULES3 * VerDate Sep<11>2014 N/A 111 19:26 Nov 21, 2018 Jkt 247001 PO 00000 pulation Health Process Frm 00386 Community/Po pulation Health Fmt 4701 Sfmt 4725 Medication Reconciliation Post-Discharge: The percentage of discharges from any inpatient facility (for example hospital, skilled nursing facility, or rehabilitation facility) for patients 18 years and older of age seen within 30 days following discharge in the office by the physician, prescribing practitioner, registered nurse, or clinical pharmacist providing on-going care for whom the discharge medication list was reconciled with the current medication list in the outpatient medical record. This measure is reported as three rates stratified by age group: • Submission Criteria 1: 18-64 years of age. • Submission Criteria 2: 65 years and older. • Total Rate: All patients 18 years of age and older. Advance Care Plan: Percentage of patients aged 65 years and older who have an advance care plan or surrogate decision maker documented in the medical record or documentation in the medical record that an advance care plan was discussed but the patient did not wish or was not able to name a surrogate National Committee Quality Assurance National Committee Quality Assurance Urinary Incontinence: Plan of Care for Urinary Incontinence in Women Aged 65 Years and Older: Percentage of female patients aged 65 years and older with a diagnosis of urinary incontinence with a documented plan of care for urinary incontinence at least once within 12 months. Preventive Care and Screening: Influenza Immunization: Percentage of patients aged 6 months and older seen for a visit between October 1 and March 31 who received an influenza immunization OR who reported previous receipt of an influenza immunization. National Committee Quality Assurance Pneumococcal Vaccination Status for Older Adults: Percentage of patients 65 years of age and older who have ever received a vaccine. National Committee Quality Assurance E:\FR\FM\23NOR3.SGM 23NOR3 Consortium for Performance Improvement ER23NO18.203</GPH> Measure Specifications, MIPSCQMs Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60221 B.30. Geriatrics 130 CMS68 v8 Medicare Part BC1aims Measure Specifications, eCQM Specifications, MIPSCQMs Specifications Process Patient Safety ! (Care Coordinat ion) 0420 131 NIA Medicare Part BClaims Measure Specifications, MIPSCQMs Process Communication and Care Coordination NIA 181 N/A Medicare Part B Claims Measure Specifications, MIPSCQMs Specifications Process Patient Safety 0022 238 CMS15 6v7 eCQM Specifications, MIPSCQMs Specifications Process Patient Safety 2872 281 CMS14 9v7 eCQM Specifications Process Effective Clinical Care MIPS CQMs Specifications Process MIPS CQMs Specifications Process MIPS CQMs Specifications Process (Patient Safety) ! (Patient Safety) A A amozie on DSK3GDR082PROD with RULES3 ! (Patient Safety) VerDate Sep<11>2014 N/A 286 19:26 Nov 21, 2018 N/A Jkt 247001 PO 00000 Clinical Care Clinical Care Frm 00387 Patient Safety Fmt 4701 Sfmt 4725 Documentation of Current Medications in the Medical Record: Percentage of visits for patients aged 18 years and older for which the eligible professional or eligible clinician attests to documenting a list of current medications using all inunediate resources available on the date of the encounter. This list must include ALL known prescriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutritional) supplements AND must contain the medications' name, and route of administration. Pain Assessment and Follow-Up: Percentage of visits for patients aged 18 years and older with documentation of a pain assessment using a standardized tool(s) on each visit AND documentation of a follow-up plan when Elder Maltreatment Screen and Follow-Up Plan: Percentage of patients aged 65 years and older with a documented elder maltreatment screen using an Elder Maltreatment Screening Tool on the date of encounter AND a documented followUse of High-Risk Medications in the Elderly: Percentage of patients 6565 years of age and older who were ordered high-risk medications. Two rates are reported. a. Percentage of patients who were ordered at least one high-risk medication. b. Percentage of patients who were ordered at medications. least two of the same Dementia: Cognitive Assessment: Percentage of patients, regardless of age, with a diagnosis of dementia for whom an assessment of cognition is performed and the results reviewed at least once within a 12-month Dementia: Functional Status Assessment: Percentage of patients with dementia for whom an assessment of functional status was performed at least once in the last 12 months. Dementia Associated Behavioral and Psychiatric Symptoms Screening and Management: Percentage of patients with dementia for whom there was a documented symptoms screening for behavioral and psychiatric symptoms, including depression, AND for whom, if symptoms screening was positive, there was also documentation of recommendations for in the last 12 months. Dementia: Safety Concern Screening and Follow-Up for Patients with Dementia: Percentage of patients with dementia or their caregiver(s) for whom there was a documented safety concerns screening in two domains of risk: to self or and E:\FR\FM\23NOR3.SGM 23NOR3 Centers for Medicare& Medicaid Services Centers for Medicare& Medicaid Services Centers for Medicare& Medicaid Services National Committee Quality Assurance Physician Consortium for Performance Academy of Neurology American Academy of Neurology ER23NO18.204</GPH> 0419 ! (Patient Safety) 60222 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.30. Geriatrics ! (Care Coordinat ion) N/A 288 N/A MIPS CQMs Specifications Process 0710 370 CMS15 9v7 eCQM Specifications, CMS Web Interface Measure Specifications, MIPSCQMs Outcome § ! (Outcome ) ! (Opioid) N/A 408 N/A ! (Opioid) Communication and Care Coordination Clinical Care Process Effective Clinical Care Process Specifications ! (Opioid) N/A 414 § ! (Outcome 0213 455 N/A Clinical Care MIPS CQMs Specifications Process MIPSCQMs Specifications Outcome MIPS CQMs Specifications Process Effective Clinical Care Clinical Care ) N/A 474 N/A Community!Po pulation Health environmental risks; and if safety concerns screening was positive in the last 12 months, there was documentation of mitigation recommendations, including but not limited to referral to other resources. Dementia: Education and Support of Caregivers for Patients with Dementia: Percentage of patients with dementia whose caregiver(s) were provided with education on dementia disease management and health behavior changes AND were referred to additional resources for support in the last 12 months. Depression Remission at Twelve Months: The percentage of adolescent patients 12 to 17 years of age and adult patientsl8 years of age or older with major depression or dysthymia who reached remission 12 months(+/- 60 days) after an index event date. Opioid Therapy Follow-up Evaluation: All patients 18 and older prescribed opiates for longer than 6 weeks duration who had a followup evaluation conducted at least every 3 months during Opioid Therapy documented in the medical record. Documentation of Signed Opioid Treatment Agreement: All patients 18 and older prescribed opiates for longer than 6 weeks duration who signed an opioid treatment agreement at least once during Opioid Therapy documented in the medical record. Evaluation or Interview for Risk ofOpioid Misuse: All patients 18 and older prescribed opiates for longer than 6 weeks duration evaluated for risk of opioid misuse using a brief validated instrument (for example Opioid Risk Tool, SOAPP-R) or patient interview documented at least once during in the medical record. Percentage of Patients Who Died from Cancer Admitted to the Intensive Care Unit (ICU) in the Last 30 Days of Life (lower score - better): Percentage of patients who died from cancer of life. admitted to the ICU in the last 30 Zoster (Shingles) Vaccination: The percentage of patients 50 years of age and older who have a Varicella Zoster (shingles) Comment: One commenter recommended that this measure set be finalized. The commenter appreciated CMS' support of measures for the geriatrics population that CMS expends the most resources. The commenter noted that measure: Q474: Zoster (Shingles) Vaccination is not presently covered under Medicare Part B. The only Part B covered vaccines are influenza, hepatitis, and pneumococcal pneumonia. Because the Zoster (Shingles) vaccine is covered under Part D patients may incur cost-sharing obligations. FINAL ACTION: We are finalizing the Geriatrics Specialty Measure Set as proposed for the 2019 Performance Period and future years with the exception of the newly proposed composite measure: Falls: Screening, Risk-Assessment, and Plan of Care to Prevent Future Falls. We are no longer finalizing the inclusion of the falls measure because it must be vetted to utilize standardized tools that would the at-risk VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00388 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.205</GPH> amozie on DSK3GDR082PROD with RULES3 Response: This measure is being implemented as a MIPS CQM measure specification which allows all payer data. We appreciate the concern but believe this is a valuable measure that will promote the vaccination and open dialogue between the patient eligible clinician regarding the benefits of this vaccine. 60223 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.31. Urgent Care In addition to the considerations discussed in the introductory language of Table Bin this final rule, the Urgent Care specialty set takes into consideration the following criteria, which includes, but is not limited to: the measure reflects current clinical guidelines and the coding of the measure includes the specialists. We may reassess the appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. This is a new specialty set for 2019; therefore, we are not removing any measures from this specialty set. B.31. Urgent Care v7 ! (Appropri ate Use) N/A 066 ! (Appropri ate Use) 0653 091 ! (Appropri ate Use) 0654 093 CMS146 v7 N/A and Cost Reduction eCQM Specifications, MIPSCQMs Specifications Process Part BCiaims Measure Specifications, MIPSCQMs Specifications Process Medicare Part BCiaims Measure Specifications, MIPSCQMs Specifications Process Efficiency and Cost Reduction Clinical Care Efficiency and Cost Reduction Process Specifications and Cost Reduction (Appropri ate Use) ! (Patient Safety) 0419 130 ! (Care Coordinat ion) 0420 131 amozie on DSK3GDR082PROD with RULES3 Medicare Part BClaims Measure Specifications, eCQM Specifications, MIPSCQMs Specifications Part Process Patient Safety Process ation and Care Coordinatio n 0028 VerDate Sep<11>2014 CMS68v 8 226 19:26 Nov 21, 2018 CMS138 v7 Jkt 247001 Medicare Part BClaims Measure Specifications, eCQM PO 00000 Process Frm 00389 Community /Population Health Fmt 4701 Sfmt 4725 Appropriate Treatment for Children with Upper Respiratory Infection {URI): Percentage of children 3 months-18 years of age who were diagnosed with upper respiratory infection (URI) and were not dispensed an antibiotic on or 3 after the Appropriate Testing for Children with Pharyngitis: Percentage of children 3-18 years of age who were diagnosed with pharyngitis, ordered an antibiotic and received a group A streptococcus (strep) test for the Committee for Quality Assurance National Committee for Quality Assurance Acute Otitis Exterua (AOE): Topical Therapy: Percentage of patients aged 2 years and older with a diagnosis of AOE who were prescribed topical preparations. Acute Otitis Exterua (AOE): Systemic Antimicrobial Therapy-Avoidance of Inappropriate Use: Percentage of patients aged 2 years and older with a diagnosis of AOE who were not prescribed systemic antimicrobial therapy. Avoidance of Antibiotic Treatment iu Adults With Acute Bronchitis: The percentage of adults 18-64 years of age with a diagnosis of acute bronchitis who were not prescribed an antibiotic Documentation of Current Medications in the Medical Record: Percentage of visits for patients aged 18 years and older for which the eligible professional or eligible clinician attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list must include ALL known prescriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutritional) supplements AND must contain the medications' name, dosage, and route of administration. Pain Assessment and Follow-Up: Percentage of visits for patients aged 18 years and older with documentation of a pain assessment using a standardized tool(s) on each visit AND documentation of a follow-up plan when pain is Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: a. Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months. b. and older E:\FR\FM\23NOR3.SGM 23NOR3 Committee for Quality Assurance Centers for Medicare & Medicaid Services Centers Medicare & Medicaid Services Physician Consortium for Performance Improvement ER23NO18.206</GPH> ! (Appropri ate Use) 60224 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.31. Urgent Care N/A 317 CMS22v 7 ! (Appropri ate Use) Process MIPS CQMs Specifications Process Community /Population Health and Cost Reduction ! (Appropri ate Use) N/A 332 N/A MIPS CQMs Specifications Process Efficiency and Cost Reduction ! (Appropri ate Use) N/A 333 N/A MIPS CQMs Specifications Efficiency Efficiency and Cost Reduction N/A 402 N/A MIPS CQMs Specifications Process Community /Population Health ! (Patient Safety) amozie on DSK3GDR082PROD with RULES3 Medicare Part BClaims Measure Specifications, eCQM Specifications, MIPSCQMs VerDate Sep<11>2014 2152 431 0657 464 19:26 Nov 21, 2018 N/A Jkt 247001 MIPSCQMs Specifications Process Community /Population Health MIPSCQMs Specifications Process Patient Safety, Efficiency and Cost Reduction PO 00000 Frm 00390 Fmt 4701 Sfmt 4725 who were screened for tobacco use and identified as a tobacco user who received tobacco cessation intervention. c. Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user. Preventive Care and Screening: Screening for High Blood Pressure and Follow-Up Documented: Percentage of patients aged 18 years and older seen during the submitting period who were screened for high blood pressure AND a recommended follow-up plan is documented based on the current blood pressure (BP) reading as indicated. Centers for Medicare & Medicaid Services Adult Sinusitis: Antibiotic Prescribed for Acute Viral Sinusitis (Overuse): Percentage of patients, aged 18 years and older, with a diagnosis of acute viral sinusitis who were prescribed an antibiotic within 10 days after onset of symptoms. Adult Sinusitis: Appropriate Choice of Antibiotic: Amoxicillin With or Without Clavulanate Prescribed for Patients with Acute Bacterial Sinusitis (Appropriate Use): Percentage of patients aged 18 years and older with a diagnosis of acute bacterial sinusitis that were prescribed amoxicillin, with or without clavulanate, as a first line antibiotic at the time of Adult Sinusitis: Computerized Tomography (CT) for Acute Sinusitis (Overuse): Percentage of patients aged 18 years and older with a diagnosis of acute sinusitis who had a computerized tomography (CT) scan of the paranasal sinuses ordered at the time of diagnosis or received within 28 The percentage of adolescents 12 to 20 years of age with a primary care visit during the measurement year for whom tobacco use status was documented and received help with quitting if identified as a tobacco user. Preventive Care and Screening: Unhealthy Alcohol Use: Screening & Brief Counseling: Percentage of patients aged 18 years and older who were screened for unhealthy alcohol use using a systematic screening method at least once within the last 24 months AND who received brief counseling if identified as an alcohol user. Otitis Media with Effusion (OME): Systemic Antimicrobials- Avoidance oflnappropriate Use: Percentage of patients aged 2 months through 12 years with a diagnosis of OME who were not prescribed systemic antimicrobials. E:\FR\FM\23NOR3.SGM 23NOR3 American Academy of Otolaryngology -Head and Neck Surgery Foundation (AAOHNSF) American Academy of Otolaryngology -Head and Neck Surgery Foundation Committee for Quality Assurance Physician Consortium for Performance Improvement ER23NO18.207</GPH> CMS Web Interface Measure Specifications, MIPSCQMs Specifications Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60225 VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00391 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.208</GPH> amozie on DSK3GDR082PROD with RULES3 B.31. Urgent Care 60226 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations B.32. Skilled Nursing Facility In addition to the considerations discussed in the introductory language of Table Bin this final rule, the Skilled Nursing Facility specialty set takes into consideration the following criteria, which includes, but is not limited to: the measure reflects current clinical guidelines and the coding of the measure includes the specialists. We may reassess the appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. This is a new specialty set for 2019; therefore, we are not removing any measures from this specialty set. B.32. Skilled Nursing Facility Association § 0070 007 CMS145 v7 eCQM Specifications, MIPS CQMs Specifications v7 Specifications, MIPS CQMs Specifications Process Effective Clinical Care Process amozie on DSK3GDR082PROD with RULES3 VerDate Sep<11>2014 Physician Consortium for 0326 047 N!A Medicare Part BClaims Measure Specifications, MIPS CQMs Specifications Process Communic ation and Care Coordinatio n 0041 110 CMS147 v8 Medicare Part BClaims Measure Specifications, eCQM Specifications, CMS Web Interface Measure Specifications, MIPS CQMs Process Community /Population Health Preventive Care and Screening: Influenza Immunization: Percentage of patients aged 6 months and older seen for a visit between October 1 and March 31 who received an influenza immunization OR who reported previous receipt of an influenza immunization. Physician Consortium for 0066 118 N/A MIPS CQMs Specifications Process Effective Clinical Care Coronary Artery Disease (CAD): AngiotensinConverting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) TherapyDiabetes or Left Ventricular Systolic Dysfunction (LVEF < 40% ): Percentage of patients aged 18 years and older with a diagnosis of coronary artery disease seen within a 12-month period who also have diabetes OR a current or prior Left Ventricular Ejection Fraction (L VEF) < 40 percent who were ACE inhibitor or ARB American Heart Association (Care Coordinat ion) § Clinical Care Coronary Artery Disease (CAD): Beta-Blocker Therapy- Prior Myocardial Infarction (MI) or Left Ventricular Systolic Dysfunction (LVEF < 40%): Percentage of patients aged 18 years and older with a diagnosis of coronary artery disease seen within a 12month period who also have a prior MI OR a current or prior L VEF <40 percent who were prescribed betablocker Heart Failure (HF): Beta-Blocker Therapy for Left Ventricular Systolic Dysfunction (LVSD): Percentage of patients aged 18 years and older with a diagnosis of heart failure (HF) with a current or prior left ventricular ejection fraction (L VEF) < 40 percent who were prescribed beta-blocker therapy either within a 12-month period when seen in the outpatient OR at each Advance Care Plan: Percentage of patients aged 65 years and older who have an advance care plan or surrogate decision maker documented in the medical record or documentation in the medical record that an advance care plan was discussed but the patient did not wish or was not able to name a surrogate decision maker or 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00392 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 National Committee for Quality Assurance ER23NO18.209</GPH> Care Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60227 B.32. Skilled Nursing Facility Percentage of patients aged 65 years and older with a history of falls who had a risk assessment for falls completed within 12 months. ! (Care Coordinat ion) ! (Patient Safety) § Medicare Part BClaims Measure Specifications, MIPS CQMs Communic ation and Care Coordinatio n 0101 155 NIA NIA 181 NIA Medicare Part BClaims Measure Specifications, MIPS CQMs Process Patient Safety NIA 317 CMS22v 7 Medicare Part BClaims Measure Specifications, eCQM Specifications, MIPS CQMs Process Community /Population Health 1525 326 NIA Medicare Part BClaims Measure Specifications, MIPS CQMs Specifications Process Effective Clinical Care NIA 474 NIA MIPS CQMs Specifications Process Process Falls: Plan of Care: Percentage of patients aged 65 years and older with a history of falls who had a plan of care for falls documented within 12 months. National Committee for Quality Assurance Elder Maltreatment Screen and Follow-Up Plan: Percentage of patients aged 65 years and older with a documented elder maltreatment screen using an Elder Maltreatment Screening Tool on the date of encounter AND a documented follow-up plan on the date of the screen. Preventive Care and Screening: Screening for High Blood Pressure and Follow-Up Documented: Percentage of patients aged 18 years and older seen during the submitting period who were screened for high blood pressure AND a recommended follow-up plan is documented based on the current blood pressure (BP) reading as indicated. Centers for Medicare& Medicaid Services Atrial Fibrillation and Atrial Flutter: Chronic Anticoagulation Therapy: Percentage of patients aged 18 years and older with nonvalvular atrial fibrillation (AF) or atrial flutter who were prescribed warfarin OR another FDAapproved anticoagulant drug for the prevention of American Heart Association Centers for Medicare& Medicaid Services Community Zoster (Shingles) Vaccination: PPRNet /Population The percentage of patients 50 years of age and older Health who have a Varicella Zoster vaccination. Comment: One commenter was pleased to see the new proposed Skilled Nursing Facility Specialty Measure Set. The commenter noted this is the first step to delineating the SNF/NF setting as an integral but different area of practice of medicine that deserves its own consideration within MIPS and APM programs. However, the commenter noted that while there are many "reportable" measures included in the MIPS program, some measures are counter to recommendations for the SNF/NF population. The commenter requested CMS consider the following measures for this measure set; Q006: Coronary Artery Disease (CAD): Antiplatelet Therapy; Q007: Coronary Artery Disease (CAD): Beta-Blocker Therapy- Prior Myocardial Infraction (MI) or Left Ventricular Systolic Dysfunction (LVEF < 40 percent); Q047: Advance Care Plans; QllO: Preventive Care and Screening: Influenza Immunization; Q118: Coronary Artery Disease (CAD): AngiotensinConverting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) Therapy- Diabetes or Left Ventricular Systolic Dysfunction (LVEF < 40 percent); Q154: Falls: Risk Assessment (Two part measure pair with Q155); Q155: Falls: Plan of Care (Two part measure- pair with Q154); Q317: Preventive Care and Screening: Screening for High Blood Pressure and Follow-up Documented; and Q326: Atrial Fibrillation and Atrial Flutter: Chronic Anticoagulation Therapy. Other commenters were supportive of the addition of the Skilled Nursing Facility measure set. Response: We agree that this specialty set will assist clinicians who provide care within SNFs to identity measures applicable to their patient population. All of the measures suggested by the commenter (except Q 154 and Q 155) were proposed for inclusion in this specialty measure set and we agree that they are applicable to Skilled Nursing Facilities. In addition, we agree with the commenter that measures Ql54 and Ql55 should be included in this measure set for the 2019 Performance Period and future years. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00393 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.210</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION :_We are finalizing the Skilled Nursing Facility Specialty Measure Set as proposed for the 2019 Performance Period and future years with the exception of the newly proposed composite measure: Falls: Screening, Risk-Assessment, and Plan of Care to Prevent Future Falls. We are no longer finalizing the inclusion of the composite falls measure because it must be fully vetted to utilize standardized tools that would appropriately identifY the at-risk patient population. However, based on public comments, we are fmalizing the individual measures Ql54: Falls: Risk Assessment and Ql55: Falls: Plan of Care as additional measures in this measure set. 60228 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations TABLE C: Quality Measures Finalized for Removal in the 2021 MIPS Payment Year and Future Years In this final rule, we removed 26 previously finalized quality measures from the MIPS Program for the 2021 MIPS payment year and future years. These measures are discussed in detail below. As discussed in section III.I.3.h.(2)(b) of the final rule, please note that our measure removal criteria considers the following: Whether the removal of the measure impacts the number of measures available to a specific specialty • • Whether the measure addresses a priority area of the Meaningful Measures Initiative Whether the measure is linked closely to improved outcomes in patients • Further considerations are given in the evaluation of the measure's performance data, to determine whether there is or no longer is variation in performance. As discussed in section III.I.3.h.(2)(b) of this final rule, we applied additional criteria this year for the removal of measures, such as: extreme topped out measures, which means measures that are topped-out with an average (mean) performance rate between 98-100 percent. 0088 018 CMS167v 7 eCQM Specifications Process Effective Clinical Care Diabetic Retinopathy: Documentation of Presence or Absence of Macular Edema and Level of Severity of Retinopathy: Percentage of patients aged 18 years and older with a diagnosis of diabetic retinopathy who had a dilated macular or fundus exam performed which included documentation of the level of severity of retinopathy and the presence or absence of macular edema during one or more office visits within 12 months. Physician Consortium for Performance Improvement Foundation (PCP!®) 0134 043 NIA MIPSCQMs Specifications Process Effective Clinical Care Coronary Artery Bypass Graft (CABG): Use of Internal Mammary Artery (IMA) in Patients with Isolated CABG Surgery: Percentage of patients aged 18 years and older undergoing isolated CABG surgery who received an IMAgraft. Society of Thoracic Surgeons NIA 099 NIA Medicare Part BClaims Measure Process Effective Clinical Care Breast Cancer Resection Pathology Reporting: pT Category (Primary College of American Pathologists VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00394 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM We proposed removal of this measure (finalized in (81 FR 77558 through 77675)) because it is duplicative both in concept and patient population as the currently adopted Measure 019: Diabetic Retinopathy: Communication with the Physician Managing Ongoing Diabetes Care (fmalized in (81 FR 77558 through 77675)). Measure 019 is considered high priority because it promotes communication and care coordination with eligible clinicians managing diabetes care. The numerator of Measure 018 is considered the standard of care as it captures an assessment with no additional clinical action. Measure 018 neither assesses a clinical outcome nor one of the defined MIPS areas. We proposed removal of this measure (finalized in (81 FR 77558 through 77675)) because there is no longer variation in performance for the measure to be able to evaluate improvement in performance making this measure extremely topped-out as discussed in section III.I.3.h.(2) of this final rule. The average performance for this measure is 99 percent based on the current MIPS benchmarking data available at h!!ns://www.cms.gov/Medicare/Qu ali:tY-Payment-Program/ResourceLibrary/20 18-Quali:tYBenchmarks.zip. Therefore, we believe use ofiMA has been widely accepted and implemented. The measure neither assesses a clinical outcome nor one of the areas. defined MIPS We proposed removal of this measure (finalized in (81 FR 77558 through 77675)) because it is of care 23NOR3 ER23NO18.211</GPH> amozie on DSK3GDR082PROD with RULES3 TABLE C: Quality Measures Finalized for Removal in the 2021 MIPS Payment Year and Future Years Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60229 TABLE C: Quality Measures Finalized for Removal in the 2021 MIPS Payment Year and Future Years N/A03 92 100 N/A MIPSCQMs Specifications 122 amozie on DSK3GDR082PROD with RULES3 0566 VerDate Sep<11>2014 140 Medicare Part BClaims Measure Specifications, MIPS CQMs Specifications N/A 19:26 Nov 21, 2018 Medicare Part BClaims Measure Specifications, MIPS CQMs Specifications Jkt 247001 a limited opportunity to improve clinical outcomes since performance on this measure is extremely high and unvarying making this measure extremely topped-out as discussed in section III.I.3.h.(2) of this final rule. The average performance for this measure is 99 percent based on the current MIPS benchmarking data available at (Regional Lymph Nodes) with Histologic Grade: Percentage of breast cancer resection pathology reports that include the pT category (primary tumor), the pN category (regional lymph nodes), and the histologic grade Process Effective Clinical Care ate Outcome Clinical Care Process Effective Clinical Care PO 00000 Frm 00395 Colorectal Cancer Resection Pathology Reporting: pT Category (Primary Tumor) and pN Category (Regional Lymph Nodes) with Histologic Grade: Percentage of colon and rectum cancer resection pathology reports that include the pT category (primary tumor), the pN category (regional lymph nodes) and the histologic grade Adult Kidney Disease: Blood Pressure Management: Percentage of patient visits for those patients aged 18 years and older with a diagnosis of chronic kidney disease (CKD) (stage 3, 4, or 5, not receiving Renal Replacement Therapy [RRT]) with a blood pressure< 140/90 mmHg OR 2: 140/90 mmHg with a documented of care. Age-Related Macular Degeneration (AMD): Counseling on Antioxidant Supplement: Percentage of patients aged 50 years and older with a diagnosis of age-related macular degeneration (AMD) or their Fmt 4701 Sfmt 4725 College of American Pathologists ity-Payment-Program!ResourceLib!1![Y/20 18-QualityBenchmarks.zip. In addition, the measure does not assess a clinical outcome nor one of the defined areas. MIPS We proposed removal of this measure (finalized in (81 FR 77558 through 77675)) because it is considered a standard of care that has a limited opportunity to improve clinical outcomes since performance on this measure is extremely high and unvarying making this measure extremely topped-out as discussed in section III.I.3.h.(2) of this final rule. The average performance for this measure is 99.5 percent based on the current MIPS benchmarking data available at ht!Jls://www.cms.gov/Medicare/Qu ality-Payment-Program!ResourceLibr!!Q:/20 18-QualityBenchmarks.zip. In addition, the measure neither assesses a clinical outcome nor one of the defined MIPS Physicians Association measure (finalized in 81 FR 77558 through 77675) because the measure has neither been updated nor planned to be updated by the measure steward to reflect the current clinical guidelines as indicated by the measure steward. American Academy of Ophthalmolo gy We proposed removal of this measure (finalized in (81 FR 77558 through 77675)) because the measure neither assesses a clinical outcome nor one of the defined MIPS high priority areas. The measure's quality action that only requires the provision of counseling of AREDS risk factors, but does E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.212</GPH> MIPS CQMs Specifications 60230 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations N/A 156 N/A Medicare Part B Claims Measure Specifications, MIPS CQMs Specifications Process Patient Safety 0056 163 CMS123v 7 eCQM Specifications Process Effective Clinical Care 0068 204 CMS164v 7 Medicare Part B Claims Measure Specifications, eCQM Process VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Effective Clinical Care Frm 00396 counseled within the 12month performance period on the benefits and/or risks of the AgeRelated Eye Disease Study (AREDS) 2 formulation for preventing progression of AMD. Oncology: Radiation Dose Limits to Normal Tissues: Percentage of patients, regardless of age, with a diagnosis of breast, rectal, pancreatic or lung cancer receiving 3D conformal radiation therapy who had documentation in medical record that radiation dose limits to normal tissues were established prior to the initiation of a course of3D conformal radiation for a minimum of two tissues. AREDS if risks/adverse effects are identified. American Society for Radiation Oncology We proposed removal of this measure (finalized in 81 FR 77558 through 77675) because it is considered a standard of care that has a limited opportunity to improve clinical outcomes since performance on this measure is extremely high and unvarying making this measure extremely topped-out as discussed in section III.I.3.h.(2) of this final rule. The average performance for this measure is 97.5 percent based on the current MIPS benchmarking data available at htt!)s://www.cms.gov/Medicare/Qu ality-Payment-Program/ResourceLibrary/20 IS-Quality- Comprehensive Diabetes Care: Foot Exam: The percentage of patients 18-75 years of age with diabetes (type 1 and type 2) who received a foot exam (visual inspection and sensory exam with mono filament and a pulse exam) during the measurement year. National Committee for Quality Assurance Ischemic Vascular Disease (IVD): Use of Aspirin or Another Antiplatelet: Percentage of patients 18 years of age and older who National Committee for Quality Assurance We proposed removal of this measure (finalized in 81 FR 77558 through 77675) because it is duplicative to the currently adopted Measure 126: Diabetes Mellitus: Diabetic Foot and Ankle Care, Peripheral NeuropathyNeurological Evaluation (finalized in 81 FR 77558 through 77675). However, Measure 163 is designated as a core performance measure by the Core Quality Measures Collaborative (htiDs://www.cms.gov/Medicare/Q uality-Initiatives-PatientAssessmentInstruments/QualityMeasures/Core CQMs.html). Therefore, we specifically seek comments regarding the impact of removing this measure and replacing it with Measure 126. We strive to not duplicate measures in the program. We believe Measure 126 is a more appropriate measure because it targets an at-risk patient population, is clinically significant, and is in alignment with current clinical guidelines for neurological evaluation of diabetic We proposed removal of this measure (finalized in 81 FR 77558 through 77675) because it would be duplicative of a component within the existing measure Q441: Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.213</GPH> amozie on DSK3GDR082PROD with RULES3 TABLE C: Quality Measures Finalized for Removal in the 2021 MIPS Payment Year and Future Years Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60231 TABLE C: Quality Measures Finalized for Removal in the 2021 MIPS Payment Year and Future Years myocardial infarction (AMI), coronary artery bypass graft (CABG) or percutaneous coronary interventions (PC!) in the 12 months prior to the measurement period, or who had an active diagnosis of ischemic vascular disease (lVD) during the measurement period, and had documentation of use of aspirin or another antiplatelet during the measurement None Outcome Measure We strive to not duplicate measures in the program. In this case, we concluded that measure Q204 is captured within the more robust composite measure Q441. N/A 224 N/A MIPS CQMs Specifications Process Efficiency and Cost Reduction Melanoma: Avoidance of Overutilization of Imaging Studies: Percentage of patients, regardless of age, with a current diagnosis of stage 0 through IIC melanoma or a history of melanoma of any stage, without signs or symptoms suggesting systemic spread, seen for an office visit during the oneyear measurement period, for whom no diagnostic imaging studies were ordered. American Academy of Dermatology We proposed removal of this measure (finalized in 81 FR 77558 through 77675) because it is considered a standard of care that has a limited opportunity to improve clinical outcomes since performance on this measure is extremely high and unvarying making this measure extremely topped-out as discussed in section III.I.3.h.(2) of this final rule. The average performance for this measure is 99.5 percent based on the current MIPS benchmarking data available at ht!Ils://www.cms.gov/Medicare/Qu ali.ty-Payment-Program/ResourceLibrary/20 18-Quali.ty- N/A 251 N/A Medicare Part BClaims Measure Specifications, MIPS CQMs Specifications Structure Effective Clinical Care Quantitative Immunohistochemical (ill C) Evaluation of Human Epidermal Growth Factor Receptor 2 Testing (HER2) for Breast Cancer Patients: This is a measure based on whether quantitative evaluation of Human Epidermal Growth Factor Receptor 2 Testing (HER2) by immunohistochemistry (IHC) uses the system recommended in the current ASCO/CAP Guidelines for Human Epidermal Growth Factor Receptor 2 Testing in breast cancer College of American Pathologists 1519 257 N/A MIPS CQMs Specifications Process Effective Clinical Care Statin Therapy at Discharge after Lower Extremity Bypass (LEB): Percentage of patients aged 18 years and older undergoing infra-inguinal lower extremity bypass who Society for Vascular Surgeons We proposed removal of this measure (finalized in 81 FR 77558 through 77675) because it is considered a standard of care that has a limited opportunity to improve clinical outcomes since performance on this measure is extremely high and unvarying making this measure extremely topped-out as discussed in section III.I.3.h.(2) of this final rule. The average performance for this measure is 99 percent based on the current MIPS benchmarking data available at httgs://www.cms.gov/Medicare/Qu ali.ty-Payment-Program/ResourceLibrru:y/20 18-Quali.tyBenchmarks.zig. In addition, the measure does not assess a clinical outcome or one of the defined MIPS areas. We proposed removal of this measure (finalized in 81 FR 77558 through 77675) because the clinical concept is captured within currently adopted Measure 438: Statin Therapy for the Prevention and Treatment of Cardiovascular VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00397 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.214</GPH> amozie on DSK3GDR082PROD with RULES3 CMSWeb Interface Measure Specifications, MIPS CQMs Specifications 60232 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations TABLE C: Quality Measures Finalized for Removal in the 2021 MIPS Payment Year and Future Years amozie on DSK3GDR082PROD with RULES3 N/A 278 N/A N/A 263 N/A N/A 327 N/A VerDate Sep<11>2014 19:26 Nov 21, 2018 MIPS CQMs Specifications MIPS CQMs Specifications MIPS CQMs Specifications Jkt 247001 Clinical Care Process Process Process PO 00000 Effective Clinical Care Effective Clinical Care Effective Clinical Care Frm 00398 Sleep Apnea: Assessment of Sleep Symptoms: Percentage of visits for patients aged 18 years and older with a diagnosis of obstructive sleep apnea that includes documentation of an assessment of sleep symptoms, including presence or absence of snoring and daytime sleepiness. Sleep Apnea: Positive Airway Pressure Therapy Prescribed: Percentage of patients aged 18 years and older with a diagnosis of moderate or severe obstructive sleep apnea who were prescribed positive airway pressure therapy. Preoperative Diagnosis of Breast Cancer: The percent of patients undergoing breast cancer operations who obtained the diagnosis of breast cancer preoperatively by a minimally invasive biopsy method. Pediatric Kidney Disease: Adequacy ofVolume Management: Percentage of calendar months within a 12-month Fmt 4701 Sfmt 4725 Academy of Sleep Medicine American Academy of Sleep Medicine American Society of Breast Surgeons Renal Physicians Association E:\FR\FM\23NOR3.SGM measure (finalized in 81 FR 77558 through 77675) because it is duplicative to the currently adopted Measure 277: Sleep Apnea: Severity Assessment at Initial Diagnosis (finalized in 81 FR 77558 through 77675). Measure 276 only represents a quality action to assess for the sleep symptoms whereas Measure 277 includes the assessment along with the severity. This measure also lacks a quality action for positive assessments and does not indicate the use of a standardized tool. Also, the measure does not assess a clinical outcome nor one of the defined MIPS areas. We proposed removal of this measure (finalized in 81 FR 77558 through 77675) because it is duplicative to currently adopted Measure 279: Sleep Apnea: Assessment of Adherence to Positive Airway Pressure Therapy (finalized in 81 FR 77558 through 77675). Measure 279 is more robust and requires assessment of adherence to the therapy. Measure 278 does not assess a clinical measure (finalized in 81 FR 77558 through 77675) because it is considered a standard of care that has a limited opportunity to improve clinical outcomes since performance on this measure is extremely high and unvarying. The average performance for this measure is 99.3 percent based on the current MIPS benchmarking data available at httns://www.cms.gov/Medicare/Qu ali.!y-Payment-Program!ResourceLibrm:y/20 18-Quali.!yBenchmarks.zip. In addition, the measure does not assess a clinical outcome nor one of the defined MIPS areas. We proposed removal of this measure (finalized in 81 FR 77558 through 77675) because it is considered a standard of care that has limited to 23NOR3 ER23NO18.215</GPH> Specifications Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60233 TABLE C: Quality Measures Finalized for Removal in the 2021 MIPS Payment Year and Future Years improve clinical outcomes as it does not require a quality action if adequate volume management is not achieved .. In addition, the measure does not assess a clinical outcome nor one of the defined MIPS high priority areas. N/A 334 N/A MIPS CQMs Specifications Efficiency Efficiency and Cost Reduction Adult Sinusitis: More than One Computerized Tomography (CT) Scan Within 90 Days for Chronic Sinusitis (Overuse): Percentage of patients aged 18 years and older with a diagnosis of chronic sinusitis who had more than one CT scan of the paranasal sinuses ordered or received within 90 days after the date of diagnosis. N/A 359 N/A MIPS CQMs Specifications Process Communi cation and Care Coordinat ion Optimizing Patient Exposure to Ionizing Radiation: Utilization of a Standardized Nomenclature for Computed Tomography (CT) Imaging: Percentage of computed tomography ( CT) imaging reports for all patients, regardless of age, with the imaging study named according to a standardized nomenclature and the standardized nomenclature is used in institution's computer systems. American College of Radiology N/A 363 N/A MIPS CQMs Specifications Structure Communi cation and Care Coordinat ion Optimizing Patient Exposure to Ionizing Radiation: Search for Prior Computed Tomography (CT) Studies Through a Secure, Authorized, Media-Free, American College of Radiology VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00399 Fmt 4701 Sfmt 4725 American Academy of We proposed removal of this measure (finalized in 81 FR 77558 through 77675) because it is y-Head and considered a standard of care that Neck Surgery has a limited opportunity to improve clinical outcomes since performance on this measure is extremely high and unvarying making this measure extremely topped-out as discussed in section III.I.3.h.(2) of this final rule. The average performance for this measure is 1.6 percent (inverse measure where a lower score is better performance) based on the current MIPS benchmarking data available at h!!lls://www.cms.gov/Medicare/Qu ali(X-Paxment-Program/ResourceLibr!!!}'/20 18-Qualitx- E:\FR\FM\23NOR3.SGM We proposed removal of this measure (finalized in 81 FR 77558 through 77675) because it is duplicative of the currently adopted Measure 361: Optimizing Patient Exposure to Ionizing Radiation: Reporting to a Radiation Dose Index Registry (finalized in 81 FR 77558 through 77675). The use of standardized nomenclature within this measure is intended to enable reporting to Dose Index Registries to allow comparison across radiology sites. This measure does not require the submission to a Dose Index Registry as indicated in Measure 361, but merely using standard nomenclature. We will continue to maintain Measure 361 that represents a more robust quality action to submit standardized data elements to a Dose Index We proposed removal of this measure (finalized in 81 FR 77558 through 77675) because the quality action does not completely attribute to the radiologist submitting the measure. Often, the CT studies are ordered and completed by referring 23NOR3 ER23NO18.216</GPH> amozie on DSK3GDR082PROD with RULES3 period during which patients aged 17 years and younger with a diagnosis of End Stage Renal Disease (ESRD) undergoing maintenance hemodialysis in an outpatient dialysis facility have an assessment of the adequacy of volume management from a 60234 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations TABLE C: Quality Measures Finalized for Removal in the 2021 MIPS Payment Year and Future Years Percentage of final reports of computed tomography (CT) studies performed for all patients, regardless of age, which document that a search for Digital Imaging and Communications in Medicine (DICOM) format images was conducted for prior patient CT imaging studies completed at nonaffiliated external healthcare facilities or entities within the past 12-months and are available through a secure, authorized, media free, shared archive prior to an imaging study being N/A amozie on DSK3GDR082PROD with RULES3 0465 VerDate Sep<11>2014 369 423 Specifications CMS158v 7 eCQM Specifications Process Effective Clinical Care Specifications ate Outcome Clinical Care Medicare Part BClaims Measure Specifications, MIPS CQMs Specifications Process Effective Clinical Care N/A 19:26 Nov 21, 2018 Jkt 247001 Clinical Care PO 00000 Frm 00400 Bipolar Disorder and Major Depression: Appraisal for alcohol or chemical substance use: Percentage of patients with depression or bipolar disorder with evidence of an initial assessment that includes an appraisal for alcohol or chemical Pregnant women that had HBsAg testing: This measure identifies pregnant women who had an HBsAg (hepatitis B) test during their pregnancy. Hypertension: Improvement in Blood Pressure: Percentage of patients aged 18-85 years of age with a diagnosis of hypertension whose blood pressure improved during the measurement period. Perioperative Anti-platelet Therapy for Patients Undergoing Carotid Endarterectomy: Percentage of patients undergoing carotid endarterectomy (CEA) who are taking an anti-platelet within hours Fmt 4701 Sfmt 4725 Quality Assessment and Improvement in Mental Health measure (finalized in 81 FR 77558 through 77675) because the measure does not require a quality action that links to improved outcomes when assessed positive for alcohol or chemical substance use. The measure does not assess a clinical outcome or one of the defined MIPS high priority areas. Optumlnsight We proposed removal of this measure (finalized in 81 FR 77558 through 77675) because the measure steward is no longer maintaining the measure for continued utilization. Furthermore, the measure is evaluating a standard of care as this test would be part of the routine screening for women receiving prenatal care and does not evaluate for care with results. Medicare & Medicaid Services Society for Vascular Surgeons E:\FR\FM\23NOR3.SGM measure (finalized in 81 FR 77558 through 77675) because a similar clinical concept is represented in Measure 236. It is our goal to ensure duplicate measures are not included in the program. In addition, Measure 236 may apply to a larger eligible clinician cohort and offers expanded data submission methods that are not offered Measure 373. We proposed removal of this measure (finalized in 81 FR 77558 through 77675) because the clinical concept is captured within our proposed measure Ischemic Vascular Disease: Use of Aspirin or Anti-platelet Medication. We refer readers to Table A.7 where The 23NOR3 ER23NO18.217</GPH> Process 7 complete the quality action by the radiologist. This allows their quality performance score to be impacted by other eligible clinicians. In addition, the measure does not require a quality action that links to improved outcomes when the search is completed prior to the study (that is, comparison). Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60235 TABLE C: Quality Measures Finalized for Removal in the 2021 MIPS Payment Year and Future Years surgery and are prescribed this medication at hospital discharge following surgery. N/A amozie on DSK3GDR082PROD with RULES3 N/A VerDate Sep<11>2014 426 427 447 N/A N/A N/A 19:26 Nov 21, 2018 MIPS CQMs Specifications MIPSCQMs Specifications MIPSCQMs Specifications Jkt 247001 Process Communi cation and Care Coordinat ion Process Process PO 00000 Communi cation and Care Coordinat ion Communi ty/ Populatio nHealth Frm 00401 Post-Anesthetic Transfer of Care Measure: Procedure Room to a Post Anesthesia Care Unit (PACU): Percentage of patients, regardless of age, who are under the care of an anesthesia practitioner and are admitted to a P ACU or other non-ICU location in which a post-anesthetic formal transfer of care protocol or checklist which includes the key transfer of care elements is utilized. Post-Anesthetic Transfer of Care: Use of Checklist or Protocol for Direct Transfer of Care from Procedure Room to Intensive Care Unit (ICU): Percentage of patients, regardless of age, who undergo a procedure under anesthesia and are admitted to an Intensive Care Unit (I CU) directly from the anesthetizing location, who have a documented use of a checklist or protocol for the transfer of care from the responsible anesthesia practitioner to the responsible ICU team or team member. Chlamydia Screening and Follow-up: The percentage of female adolescents 16 years of age who had a chlamydia screening test with proper follow-up during the measurement period. Fmt 4701 Sfmt 4725 American Society of sts sts National Committee for Quality Assurance E:\FR\FM\23NOR3.SGM We proposed removal of this measure (finalized in 81 FR 77558 through 77675) as a quality measure from the MIPS program because it is considered a standard of care that has a limited opportunity to improve clinical outcomes since performance on this measure is extremely high and unvarying making this measure extremely topped-out as discussed in section III.I.3.h.(2) of this final rule. The average performance for this measure is 97.7 percent based on the current MIPS benchmarking data available at htms://www.cms.gov/Medicare/Qu We proposed removal of this measure (finalized in 81 FR 77558 through 77675) because it is considered a standard of care that has a limited opportunity to improve clinical outcomes since performance on this measure is extremely high and unvarying making this measure extremely topped-out as discussed in section III.I.3.h.(2) of this final rule. The average performance for this measure is 97.9 percent based on the current MIPS benchmarking data available at htms://www.cms.gov/Medicare/Qu aliJ;x-Payment-Program/ResourceLibrary/20 18-QualitxWe proposed removal of this measure (finalized in 81 FR 77558 through 77675) because it is duplicative of currently adopted Measure 310: Chlamydia Screening for Women (finalized in 81 FR 77558 through 77675). We strive to not duplicate in the program. This measure is designated as a core performance measure by the Core Quality Measures Collaborative (htms://www.cms.gov/Medicare/Q ualitx-Initiatives-Patient- 23NOR3 ER23NO18.218</GPH> N/A proposed measure captures all ischemic vascular disease patients that should be receiving an aspirin or anti-platelet medication. Whereas, Measure 423 only captures a subset of the patient population undergoing carotid 60236 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations TABLE C: Quality Measures Finalized for Removal in the 2021 MIPS Payment Year and Future Years specifically seek comments regarding the impact of removing this measure. Measures" Comment: A commenter streamline the measures used in the MIPS. to Response: We thank the commenter for their support. Comment: Several commenters opposed the removal of measure Q048: Urinary Incontinence: Assessment of Presence or Absence of Urinary Incontinence in Women Aged 65 Years. Removing the Urinary Incontinence measure will result in excluding up to half of women with urinary incontinence from quality measurement, resulting in loss of opportunity to improve outcomes. Commenters did not agree that measure Q048 is duplicative in concept and covers the same patient population as currently adopted measure Q050: Urinary Incontinence: Plan of Care for Urinary Incontinence in Women Aged 65 Years and Older." Measure Q048 is intended to promote screening for urinary incontinence, recognizing that urinary incontinence is under-reported by patients and under-evaluated by clinicians; measure Q050 is intended to ensure that women who have identified as having urinary incontinence are the evaluated and offered treatment, based on literature showing that patients reporting urinary incontinence are often not evaluated for what is otherwise a treatable condition. The denominator for measure 048 is all women aged 65 years and older, whereas the denominator for measure Q050 is all eligible women already diagnosed with urinary incontinence. Relying on measure Q050 alone for quality measurement related to urinary incontinence will exclude nearly half of women over age 65 that have urinary incontinence but have not been diagnosed. Measures 048 and 050 go hand-in-hand because interventions to increase urinary incontinence screenings (as measured by measure Q048) results in higher numbers of women receiving urinary incontinence treatment (as measured by measure Q050). Having measure Q050 without measure Q048 undermines the purpose of improving outcomes for women with urinary incontinence. Response: After further consideration, we agree with commenters that the denominator for Q050 is not duplicative of Q048 and would not capture the under diagnosis of urinary continence. Therefore, we will not finalize measure Q048 for removal as proposed. Comment: One commenter opposed the CMS proposal to retire three of the eight current Pathology measures: Q099- Breast Cancer Resection Pathology Reporting Measure, Q 100 - Colorectal Cancer Resection Pathology Reporting Measure Q251 - Quantitative Immunohistochemical (IHC) Evaluation of Human Epidermal Growth Factor Receptor 2 Testing (HER2) for Breast Cancer Patients. Removal of these measures would leave pathologists with only five QPP measures whereas the CMS requirement is to report on a minimum of six quality measures. The commenter noted that would significantly hinder successful participation by pathologists in the Quality category. Response: Although we acknowledge that removing these measures limits the number of measures specific to pathology available for reporting, we do believe removing these measures is consistent with our policy to remove measures that have an extremely high performance rate. Based on the 2018 MIPS Benchmark results reflect an average of99 percent for Q99 and Q251, and 99.5 percent for QlOO which allows limited opportunity to improve clinical outcomes. In the event an eligible clinician reports on less than 6 quality measures, because no other measures in the set are available or applicable to their scope of practice, the quality performance category score will be adjusted accordingly through the measure validation process. Comment: One commenter supported the removal of measure Q122: Adult Kidney Disease: Blood Pressure Management because it cannot estimate the clinical impact based on the information provided by the measure developers and the measure lost NQF endorsement due to a lack of evidence. This measure does not conform to society guidelines and the measure specifications do not align with clinical recommendations on disease classification. Lastly, the denominator population is burdensome for clinicians to document a care plan for all patients classified as stage 3 and above without evidence to support the benefit of the intervention on clinical outcomes. Response: We thank the commenter for their support to remove measure Q122: Adult Kidney Disease: Blood Pressure Management. Comment: One commenter disagreed with the removal of measure Q122: Adult Kidney Disease: Blood Pressure Management The commenter stated removal would threaten patient care and disputes that the measure has not been updated nor is planned to be updated. Response: We are continuously working with measure stewards to update the blood pressure values and were not updated in the annual revision cycle. We do not agree that the removal of this measure would threaten patient care. This clinical concept would also be captured in measure Q317: Preventive Care and Screening: Screening for High Blood Pressure and Follow-Up Documented. Comment: One commenter opposed the removal of measure Q156: Oncology: Radiation Dose Limits to Normal Tissues stating, not only do oncology professionals continue to find value in this measure from a patient safety standpoint, they disagree with CMS' contention that it is truly topped out. Response: This measure has a limited opportunity to improve clinical outcomes since performance on this measure is extremely high and unvarying. This does not allow meaningful benchmarks to be established. Based on the 2018 MIPS Benchmark Results, the average performance for this measure is 97.5 percent which does not allow ample opportunity to impact clinical outcomes. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00402 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.219</GPH> amozie on DSK3GDR082PROD with RULES3 Comment: One commenter supported the removal of measure Q163: Comprehensive Diabetes Care: Foot Exam measure from the from the CMS Web Interface Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60237 TABLE C: Quality Measures Finalized for Removal in the 2021 MIPS Payment Year and Future Years clinicians may need to differ to some extent, and did not agree it necessary to use the exact same measures to evaluate clinicians/groups and A COs. The commenter also noted that this measure is not used in other health plan reporting programs such as MA Star Ratings and the QRS, so its removal from MIPS will not cause misalignment with those programs. Response: We thank the commenter for their support to remove measure Ql63: Comprehensive Diabetes Care: Foot Exam from the CMS Web Interface collection type. Comment: One commenter supported removal of measure Ql63: Comprehensive Diabetes Care: Foot Care because this measure is duplicative with measure Ql26: Diabetes Mellitus: Diabetic Foot and Ankle Care, Peripheral Neuropathy-Neurological Evaluation. Measure Ql26 is the preferred and appropriate measure as it targets an at-risk patient population, is clinically significant, and is in alignment with current clinical guidelines. Response: We thank the commenter for supporting the removal of measure Ql63. Comment: One commenter did not support the removal of measure Ql63: Comprehensive Diabetes Care: Foot Exam until NQF completes its pending comparison with it and the Diabetes Mellitus: Diabetic Foot and Ankle Care measure (which the proposed rule suggests it duplicates). NQF found no significant difference in the measures' ability to identify the at-risk population or in the components of clinical assessment specified in them. More than 10,000 clinicians in NCQA's Diabetes Recognition Program report Comprehensive Diabetes Care: Foot Exam. The measure also is in the Core Quality Measures Collaborative ACO/PCMH and Primary Care set, which CMS described as "a major step forward" for quality measure alignment" and a "framework upon which future efforts can be based." Response: We agree with the commenter' s statement indicating that both measures' ability to identify the at-risk population or in the components of clinical assessment specified in them. Both measures aim to promote appropriate foot examination to identify risk factors predictive of ulcers and amputations. However, measure Q 126 requires the frequency of the exam to be increased if abnormalities are present. More frequent evaluation of the diabetic foot is recommended depending on risk category. It is through systematic examination and risk assessment, patient education, and timely referral that eligible clinicians may further reduce the unnecessarily high prevalence oflower-extremity morbidity in the diabetes population. We attempt to align with CQMC, but believe this is duplicative of a more robust measure. As MIPS moves forwards, we will continue to explore ways to align measurement across programs. Comment: A commenter did not support removal of the Ql85: Colonoscopy Interval for Patients with a History of Adenomatous Polyps- Avoidance oflnappropriate Use measure. The commenter noted that updated guidelines on the appropriate follow-up interval for patients with a history of adenomatous polyps are set to be released in the near future. The commenter also noted that it is likely that the measure specifications will be updated at that point, which may alter clinician performance. The commenter recommended that CMS retain the measure in MIPS until it is able to review other stakeholder concerns about measure performance, and that CMS work with the measure developer to update the MIPS measure specifications when new guidelines are released. Response: We agree that updated guidelines could affect the performance of this measure causing the measure to have a substantive change and therefore may no longer have a benchmark that is considered to be topped out. We note this measure shows a 97.7 percent average performance for Medicare Part B Claims Measure Specifications while the MIPS CQMs Specification (registry) version shows less than 97 percent average performance rate. Based on our extremely topped out measure removal policy, we intend to only remove this measure from the Medicare Part B Claims Measure Specification collection type for the 2019 performance period. We will not finalize the removal ofMIPS CQM collection type. We will work with the measure steward to update for the new clinical guidelines once those are released and continue to monitor the performance of the MIPS CQM Measure Specification in the future. Comment: Several commenters supported the proposed removal of the Q204: Ischemic Vascular Disease: Use of Aspirin or Another Anti-Platelet measure. Response: We thank the commenters for their support to remove measure Q204: Ischemic Vascular Disease: Use of Aspirin or Another Anti-Platelet measure. Comment: Several commenters were concerned about the removal ofQ204: Ischemic Vascular Disease (IVD): Use of Aspirin or Another Antiplatelet because its specialties have identified this measure as a high-priority measure, and therefore, requested the measure not be removed. Another commenter disagreed with removal of Q204 as the Million Hearts Campaign, Core Quality Measures Collaborative ACO/PCHM and Primary Care set and many other public and private programs use this measure. Response: We originally proposed a replacement measure that included appropriate denominator exceptions, but ultimately decided it was duplicative of measure Q441: Ischemic Vascular Disease All or None Outcome Measure (Optimal Control). Therefore, to be consistent with our policy to remove measures that are duplicative to other measures and to ensure measures are more meaningful, we have decided to not finalize inclusion of this new IVD measure. In addition, it would introduce a measure that was not aligned with the Million Hearts Campaign, Core Quality Measures Collaborative ACO/PCHM and Primary Care set. We will fmalize the proposal to remove Q204. Measure Q204 is duplicative and does not have appropriate denominator exceptions/exclusions to account for patients who are not appropriate for aspirin or antiplatelet therapy (that is, history of gastrointestinal bleeding, intracranial bleeding, bleeding disorder, allergy to aspirin or anti-platelets, or use of nonsteroidal anti-inflanunatory agents). We encourage the commenters to submit the outcome measure that addresses this concept. Comment: One commenter expressed concern on the proposed removal of measures Q224: Melanoma: Avoidance ofOverutilization oflmaging Studies and Ql56: Oncology: Radiation Dose Limits to Normal Tissues without proposing new oncology-related measures to replace them. CMS should also be mindful of the need to ensure an adequate number of applicable measures for oncologists and other specialty groups when proceeding with decisions about measure removal. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00403 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.220</GPH> amozie on DSK3GDR082PROD with RULES3 Response: We refer the commenter to review the Oncology specialty measure set that provides a narrowed list of measures applicable to the oncology specialty. The specialty measure sets are reviewed annually by stakeholders to include applicable measures. The oncology measure set contains 24 quality measures. 60238 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations TABLE C: Quality Measures Finalized for Removal in the 2021 MIPS Payment Year and Future Years patients with neurologic disorders experience sleep disturbances and disorders other than obstructive sleep apnea. They also noted that removing Q276 would result in limited reporting options for neurologists specializing in sleep care. They stated also that while it may be easier to see the value in calculating the severity of sleep apnea, as required in measure Q277; that in accordance with evidence-based Clinical Practice Guideline for Diagnostic Testing for Obstructive Sleep Apnea, diagnostic testing for obstructive sleep apnea should be performed in conjunction with a comprehensive sleep evaluation and adequate follow-up. One of the commenters noted that patients with untreated obstructive sleep apnea are also at an increased risk of being diagnosed with cardiovascular disease, difficult-to-control blood pressure, coronary artery disease, congestive heart failure, arrhythmias, and stroke. They stated further that sleep medicine professionals need relevant measures to report for participation in the MIPS program, and currently there are only four sleep medicine measures available. Response: These measures address the same patient population; however, Q276, does not identif'y a standardized tool to assess sleep symptoms whereas Q277 defines a standard method of assessment. This allows clinicians a baseline to assess if the patient is being treated appropriately. A non-standardized assessment of daytime sleepiness may be circumstantial and may not be a reliable indicator of appropriate treatment. In addition, the measure Q276 does not have a quality action if the patient is experiencing daytime sleepiness. We agree with the commenters' suggestions that sleep apnea should be performed in conjunction with a comprehensive sleep evaluation and adequate follow-up. The Q276 measure does not address the adequate follow-up component to mitigate the risks of cardiovascular disease, difficult-tocontrol blood pressure, coronary artery disease, congestive heart failure, arrhythmias, and stroke. We encourage the commenters to collaborate with measure developers to submit new measures that address sleep apnea in the Call for Measures process. In the event an eligible clinician reports on less than 6 quality measures, because no other measures in the set are available or applicable to their scope of practice, the quality performance category score will be adjusted accordingly through the measure validation process. Comment: One commenter opposed removal of Q278 Sleep Apnea: Positive Airway Pressure Prescribed and requested that the measure be categorized as a high priority patient safety measure, given the overwhelming amount of evidence in the medical literature describing the negative effects of untreated sleep disorders. They noted that patients with untreated obstructive sleep apnea are also at an increased risk of being diagnosed with cardiovascular disease, difficult-to-control blood pressure, coronary artery disease, congestive heart failure, arrhythmias, and stroke. They stated further that sleep medicine professionals need relevant measures to report for participation in the MIPS program, and currently there are only four sleep medicine measures available. Response: We are attempting to reduce reporting burden where measures are duplicative in concept or do not drive quality action by eligible clinician. We believe that this measure is low bar and choose to continue to implement measure Q279 is more robust and requires assessment of adherence to the therapy. Measure Q278 does not assess a clinical outcome nor one of the defined MIPS high priority areas. We encourage the commenters to collaborate with measure developers to submit new measures that address sleep apnea in the Call for Measures process. In the event an eligible clinician reports on less than 6 quality measures, because no other measures in the set are available or applicable to their scope of practice, the quality performance category score will be adjusted accordingly through the measure validation process. Comment: One commenter opposed removal of measure Q327: Pediatric Kidney Disease: Adequacy of Volume Management. This measure meets several national quality strategy domains - clinical care, care coordination, and patient and caregiver experience and removal of this measure would leave only one MIPS measure for pediatric nephrologists. A second commenter also opposed the removal of measure Q327 because they noted that despite the small number of Medicare pediatric patients, many pediatric nephrologists do not meet the low volume threshold and are still required to participate in the Quality Payment Program. The commenter also noted also that very few measures exist that allow pediatric nephrologists to participate meaningfully. They requested CMS not to eliminate this or any other pediatric kidney disease measures from the Quality Payment Program unless and until they can be replaced with other measures specific to pediatric kidney disease. Response: Although, we acknowledge that removing this measure limits the number of measures specific to pediatric nephrologists available for reporting, we do believe removing this measure is consistent with our policy to move towards more meaningful measures and decrease burden for eligible clinicians. This is a process measure that does not assess if there the patient had appropriate volume management, but whether the adequacy was assessed. As we move toward more outcome-based measures, we suggest the commeuter to collaborate with measure stewards to develop an outcome measure that the patient aligns with the post dialysis weight. In addition, although there are not many specific measures available, there are cross-cutting measures that we believe would be applicable to pediatric nephrologists and could be submitted. This measure is only available by CQM Measure Specification, and therefore, in the event an eligible clinician reports on less than 6 quality measures, because no other measures in the set are available or applicable to their scope of practice, the quality performance category score may be adjusted through the measure validation process as applicable. Comment: One commenter did not support the choice to remove the Q334: Adult Sinusitis CT scan measure because they noted that CMS did not follow the established process of utilizing a 4-year, step-down period for removing topped out measures. The commenter requested that CMS follow this process so that measure stewards are able to plan accordingly for other measure development before an existing measure is retired. Response: By removing these extremely topped out measures, we are attempting to reduce reporting burden where there is little room for improvement. Additionally, this allows eligible clinicians to maximize their potential quality performance category score. Based on the 2018 Benchmark File, this measure only supported the creation of deciles 3 to 5, which would limit the score awarded for the measure. Comment: One commenter opposed removal of measure Q359: Optimizing Patient Exposure to Ionizing Radiation: Utilization of a Standardized Nomenclature for Computed Tomography (CT) Imaging measure because they did not agree that it is duplicative ofQ361: OPEIR- Reporting to a Dose Index Registry, which they noted is only intended to enable reporting to a dose index registry to allow comparison across radiology sites. They stated that removing this measure may affect some radiologists' ability to meet quality measure requirements. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00404 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.221</GPH> amozie on DSK3GDR082PROD with RULES3 Response: Standardized nomenclature permits data mining in order to participate in research projects, registries, and quality improvement efforts. This facilitates a first step toward structured reporting to Radiation Dose Index Registries, which would be captured in measure Q361: Optimizing Patient Exposure to Ionizing Radiation: Reporting to a Radiation Dose Index Registry. Even with the removal of this measure, the Radiology specialty measure set has more than 6 quality measures. In the event an clinician on less than 6 because no other measures in the set are available or to their the Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60239 TABLE C: Quality Measures Finalized for Removal in the 2021 MIPS Payment Year and Future Years performance category score will be adjusted accordingly through the measure validation process. Comment: One commenter opposed the removal of measure Q363: Optimizing Patient Exposure to Ionizing Radiation: Search for Prior Computed Tomography (CT) Studies Through a Secure, Authorized, Media-Free, Shared Archive. The commenter respectfully suggested that CMS fails to appreciate the process upon which this measure has impact. It is correct that referring clinicians place orders, but radiologists would complete the exams. The measure quality action is that prior to performing the ordered exam, the radiologist would search existing image exchanges across institutions or geographic area for existing prior images for the patient. The potential improved outcome would be a reduction in patient exposure to radiation, as well as a substantial reduction when duplicative imaging procedures are avoided. Additionally, broader access to existing imaging studies, including relevant prior images used for comparative purposes of patient history (of lesions for example) could improve diagnostic specificity and accuracy for radiologists and potentially further minimize recommendations for follow-up studies. In addition, they stated that removing this measure may affect some radiologists' ability to meet quality measure requirements. Response: While we appreciate the intent to review historical images and reduce radiation, the measure requires a finalized report of a CT study to be denominator eligible. Therefore, it would exclude instances where the duplicative CT was appropriately cancelled as they would no longer be denominator eligible. An eligible clinician can be numerator compliant if a CT was completed and had identified a prior CT exam. Therefore, it does not promote radiation reduction. Even with the removal of this measure, the Radiology specialty measure set has more than 6 quality measures. In the event an eligible clinician reports on less than 6 quality measures, because no other measures in the set are available or applicable to their scope of practice, the quality performance category score will be adjusted accordingly through the measure validation process. Comment: One commenter opposed removal of measure Q373: Hypertension: Improvement in Blood Pressure measure because of its impact on patient care and low reporting burden. They noted that the data is already documented in the EHR as part of standard workflows. One commenter agreed that measure Q373: Hypertension: Improvement in Blood Pressure provides no incremental benefit over measure Q236. However, the commenter expressed concern that a one-size-fits-all SBP goal of< 140/90 mm Hg may suggest to patients and their healthcare providers that their treatment is adequate if they reach this goal. In the future, as further evidence accumulates for other cohorts of patients, the commenter hoped a more comprehensive set of blood pressure control measures that are tailored to patients' cardiovascular risk will become available for CMS reporting. Response: We are committed to our goal to remove measures that are duplicative to other measures and to be consistent with ensuring measures are more meaningful. As we indicated in our proposal, this measure is very similar in clinical concept to measure Q236: Controlling High Blood Pressure. We believe measure Q236 may apply to a larger eligible clinician cohort and offers expanded collection types that are not offered by measure Q373. Both measures are available via eCQM Specifications, and therefore, measure Q236 would have a low reporting burden since the data is already documented in the EHR as indicated by the commenter. In addition, we will continue to work with measure stewards to update the current blood pressure measures to align with clinical guidelines as appropriate or evaluate potential new measures to propose for the program. Comment: One commenter expressed concerns about Appendix Table C and that it is premature to remove measures for which replacement measures are concurrently being proposed, (for example, Falls Screening and Functional Status Assessment for Total Knee Replacement), until vendors have had the necessary time to develop, certify and deploy their respective replacement measures. Response: We provided a measure preview this year to allow for technical revisions, this also allowed vendors to gather preliminary implementation strategies. Additionally, all measure finalized will be posted on the CMS website prior to the start of the 2019 performance period. We also aim to reduce the number of duplicative measures. If we retain the Functional Status Assessment for Total Knee Replacement for the 2019 performance period, this would be duplicated measure concept of measure Q470: Average Change in Functional Status Following Total Knee Replacement Surgery. Comment: Two commenters did not support removal ofQ386: Amyotrophic Lateral Sclerosis (ALS) Patient Care Preferences from this measure set. The commenters appreciated the effort to decrease redundancy between this measure and the Q04 7 Advance Care Plan measure. While these measures do overlap, the commenters noted that ALS measure specification recognizes the likely earlier age of onset of this devastating diagnosis and the need to have earlier planning conversations around palliative and end of life care by having no minimum age requirement. For this reason, the commenter believed the measure should be retained. Response: We agree with the commenters concerns about removing measure Q386 and will not finalize this measure for removal. Specifically, we agree that patients with ALS are often younger than those in the denominator for Measure 047, which includes patients age 65 and older. For this reason, we concur with commenters that a separate measure applying to all patients with a diagnosis of ALS is clinically indicated. Comment: One commenter did not support the removal of measure Q426: Post-Anesthetic Transfer of Care Measure: Procedure Room to a Post Anesthesia Care Unit (PACU) and measure Q427: Post-Anesthetic Transfer of Care: Use of Checklist or Protocol for Direct Transfer of Care from Procedure Room to Intensive Care Unit (ICU). Their removal would jeopardize many anesthesiologists' opportunities to report the required six quality measures. The anesthesiology measure set currently includes seven anesthesia-specific measures and a handful of measures that are only reportable using evaluation and management codes-codes that are rarely reported by anesthesiologists. For anesthesiologists working in ambulatory settings and on surgeries lasting less than one hour, the number of applicable measures would be reduced to just one measure. In previous years, CMS correctly identified measures Q426 and Q427 as high-priority measures. The proposed removal of these measures would expose contradictions between CMS' intent to improve communication and care coordination with the removal of measures aimed at ensuring communication between clinicians. When considering Advanced Alternative Payment Models (APMs), and the need for entities to use measures comparable to MIPS, these two measures should be identified by those Advanced APMs as helping to reduce medical errors, adverse medication events, expedite recovery and reduce costs. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00405 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.222</GPH> amozie on DSK3GDR082PROD with RULES3 Response: Measures Q426: Post-Anesthetic Transfer of Care Measure: Procedure Room to a Post Anesthesia Care Unit (PACU) and Q427: Post-Anesthetic Transfer of Care: Use of Checklist or Protocol for Direct Transfer of Care from Procedure Room to Intensive Care Unit (ICU) are being removed as they have limited opportunity to produce clinical outcomes as the performance rates are extremely topped out. By removing these extremely topped out measures, we are attempting to reduce reporting . In the event an clinician on less than 6 because no other measures in the set are burden where there is little room for · 60240 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations TABLE C: Quality Measures Finalized for Removal in the 2021 MIPS Payment Year and Future Years available or applicable to their scope of practice, the quality performance category score will be adjusted accordingly through the measure validation process. We agree that promoting communication between clinician is important, the performance data does not support a gap in communication and drive quality improvement in this area. We encourage the commenter to work with measure developers to create a measure that promotes communication that addresses current gap in the anesthesia specialty. Comment: Another commenter did not support removal of topped out measures: Q426: Post-Anesthetic Transfer of Care Measure: Procedure Room to a Post Anesthesia Care Unit (PACU) and Q427: Post-Anesthetic Transfer of Care: Use of Checklist or Protocol for Direct Transfer of Care from Procedure Room to Intensive Care Unit (ICU). The commenter was concerned about removal of these measures as they relate to CRNAs. Without a concerted effort to expand measure specifications to include non-patient facing CPT codes, the commenter recommended that measures attributed to non-patient facing clinicians be excluded from the removal process to assure that CRNAs do not face additional burden by not having enough applicable measures to participate in MIPS. Response: Measures Q426: Post-Anesthetic Transfer of Care Measure: Procedure Room to a Post Anesthesia Care Unit (PACU) and Q427: Post-Anesthetic Transfer of Care: Use of Checklist or Protocol for Direct Transfer of Care from Procedure Room to Intensive Care Unit (ICU) are being removed as they have limited opportunity to produce clinical outcomes as the performance rates are extremely topped out. By removing these extremely topped out measures, we are attempting to reduce reporting burden where there is little room for improvement. In the event a CRNA reports on less than 6 quality measures, because no other measures in the set are available or applicable to their scope of practice, the quality performance category score will be adjusted accordingly through the measure validation process. With the measure validation process in place, we do not agree with the commenter to maintain all non-patient facing measures. Comment: Two commenters supported removal of the Q447: Chlamydia Screening and Follow-Up measure from the MIPS program. Although the measure proposed for removal is included in the CQMC OB/GYN Core Measure Set, the measure that CMS proposes to retain in MIPS, Q310: Chlamydia Screening in Women, is also a CQMC measure. The commenters agreed that the measure proposed to be retained provides more comprehensive quality information, as it includes a wider age range compared to the measure that would be remove and is limited to patients identified as sexually active. Response: We thank the commenters for their support. Comment: One commenter stated that they support CMS' outline of removal criteria to be considered when removing a measure. However, the commenter also requested that CMS evaluate measures for removal based on the collection type. For example, they noted that several eCQMs proposed for removal due to a duplicative measure being available; however, in most instances, that duplicative measure is not available as an eCQM. This would potentially force practices to maintain relationships and pay for reporting through multiple vendors to maintain their list of measures. Specifically, this affects the proposed removal of eCQMs Ql63 (Comprehensive Diabetes Care: Foot Exam), Q204 (Ischemic Vascular Disease (IVD): Use of Aspirin or Another Antiplatelet), Q318 (Falls: Screening for Future Fall Risk), and Q375 (Functional Status Assessment for Total Knee Replacement: Changes to the measure description). Another commenter expressed similar concerns about removal ofQ373: Hypertension: Improvement in Blood Pressure: Percentage of patients aged 18-85 years of age with a diagnosis of hypertension whose blood pressure improved during the measurement period. Response: In response to this concern, we conducted an analysis of the measures proposed for removal with an eCQM collection type. As a result of this analysis, we concluded that we will not finalize measures QO 12, Q318, and Q375 for removal because there is not an eCQM collection type offered in the measures that we proposed as duplicative measures. With regard to updating the removal criteria to consider data collection type overall, we will take this into consideration as we refine future removal criteria. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00406 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.223</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are finalizing the removal of these measures as proposed for the 2019 Performance Period and future years with the exception of the following measures: QOl2, Q048, Ql54, Ql55, Ql85, Q318, Q375 and Q386. Our decisions to not finalize these measures for removal in this final rule are detailed in our responses above to the public comments for these measures. Note: The new measure "Falls: Screening, Risk-Assessment, and Plan of Care to Prevent Future Falls" will not be finalized for inclusion in this f"mal rule because the measure steward believes it is not implementable at this time. Therefore, the three falls measures (Q154, Q155, because to evaluate for · and will remain in the for the 2019 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60241 TABLE Group D: Measures with Substantive Changes Finalized for the 2021 MIPS Payment Year and Future Years D.l. Medication Reconciliation Post-Discharge Cateeory NQF#: Quality#: CMSeCQMID: National Quality Strategy Domain: Current Collection Type: Description 0097 046 NIA Communication and Care Coordination Medicare Part B Claims Measure Specifications, CMS Web Interface Measure Specifications, MIPS CQMs Specifications The percentage of discharges from any inpatient facility (for example hospital, skilled nursing facility, or rehabilitation facility) for patients 18 years and older of age seen within 30 days following discharge in the office by the physician, prescribing practitioner, registered nurse, or clinical pharmacist providing on-going care for whom the discharge medication list was Current Measure reconciled with the current medication list in the outpatient medical record. This measure is reported as three rates stratified by age group: Description: o Submission Criteria 1: 18-64 years of age o Submission Criteria 2: 65 years and older o Total Rate: All patients 18 years of age and older Modified collection type: Medicare Part B Claims Measure Specifications, MIPS CQMs Specifications Substantive Chanee: National Committee for Quality Assurance Steward: Yes High Priority Measure: Process Measure Type: We removed the CMS Web Interface Measure Specifications collection type. This is a process measure, which promotes care coordination when transitioning from an inpatient facility to outpatient care. Removal of this measure from the CMS Web Interface supports our effort to move towards outcome and more meaningful measures within the CMS Web Interface. In addition, since clinicians are required to report all available CMS Web Interface measures, removing this measure from the CMS Web Interface will reduce the burden of the number of measures a clinician is required to report under the CMS Web Interface. Rationale: This measure is broadly applicable to eligible clinicians participating in the MIPS program using the collection types of Medicare Part B Claims Measure Specifications and MIPS CQMs Specifications. Retaining this measure through the Medicare Part B Claims Measure Specifications and MIPS CQMs Specifications collection types allows clinicians to choose this measure as one of the six measures clinicians are generally required to report to meet the quality performance category requirements. Comment: Commenters indicated that CMS should retain this measure because ensuring clinicians are reconciling patient medications limits the occurrence of adverse drug events for elderly patients with multiple co-morbidities and prescription medications. Response: This is a process measure that promotes care coordination when transitioning from an inpatient facility to outpatient care. While we agree that medication reconciliation is an important aspect of care coordination and avoiding adverse drug events, we believe a more broadly applicable measure that does not just focus on medication reconciliation post discharge would more effectively promote care coordination. In addition, since clinicians are required to report all available CMS Web Interface measures, removing this measure from the CMS Web Interface will reduce the burden of the number of measures a clinician is required to report under the CMS Web Interface. We do not believe removing this measure from one collection type, CMS Web Interface, will increase the occurrence of adverse drug events because eligible clinicians have the opportunity to report this measure as a Medicare Part B Claims Measure Specification or MIPS CQMs Specification. Comment: In addition, several commenters expressed general concerns that the measures we proposed to remove from the CMS Web Interface would continue to be used in other programs or that they would remain available to report to MIPS via other reporting mechanisms, creating inconsistency in the available measure set by reporting mechanism. One commenter expressed concerns about removal of the CMS Web Interface and its impact on the Medicare Shared Savings Program and ACO participants that utilize this data collection method for this measure. Response: We acknowledge that measures proposed for removal from the CMS Web Interface may continue to be required by other programs and available by other collection types. However, removing them from the CMS Web Interface would reduce burden on MIPS groups and ACO participants by removing the requirement that they actively submit the measure performance data through the CMS Web Interface. For MIPS groups, we are removing this measure to reduce burden of reporting the required measure set. However, we are retaining this measure through the Medicare Part B Claims Measure Specifications and MIPS CQMs Specifications collection types to allow clinicians an opportunity to report this measure as one of the six measures to meet the quality performance category requirements. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00407 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.224</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are finalizing the changes to measure Q046 as proposed for the 2019 Performance Period and futnre years. 60242 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations .. D 2 Pneumococcal Vaccination Status for Older Adults Cateeory NQF#: Quality#: CMSeCQMID: National Quality Strategy Domain: Current Collection Type: Current Measure Description: Substantive Chanee: Steward: Hieh Priority Measure: Measure Type: Description N/A 111 CMS127v7 Community/Population Health Medicare Part B Claims Measure Specifications, eCQM Specifications, CMS Web Interface Measure Specifications, MIPS CQMs Specifications Percentage of patients 65 years of age and older who have ever received a pneumococcal vaccine Modified collection type: Medicare Part B Claims Measure Specifications, eCQM Specifications, MIPS CQMs Specifications National Committee for Quality Assurance No Process We removed the CMS Web Interface Measure Specifications collection type. This measure has lostNQF endorsement and no longer reflects the current guidelines. A new measure is under development to reflect current guidelines and may be proposed in the future. In addition, since clinicians are required to report all available CMS Web Interface measures, removing this measure from the CMS Web Interface will reduce the burden of the number of measures a clinician is required to report under the CMS Web Interface. This measure is broadly applicable to eligible clinicians participating in the MIPS program using the collection Rationale: types of Medicare Part B Claims Measure Specifications, MIPS CQMs Specifications, and eCQM specifications. Retaining this measure through the Medicare Part B Claims Measure Specifications, MIPS CQMs Specifications, and eCQM specification collection types allows clinicians to choose this measure as one of the six measures clinicians are generally required to report to meet the quality performance category requirements. We encourage stakeholders to submit a replacement measure for future consideration that is in alignment with the most current clinical guidelines. Comment: Several commenters opposed the removal of the CMS Web Interface Measure Specifications collection type for this measure. The commenter recommended that CMS works toward immediately replacing the measure with another similar (and endorsed) measure which will lead to the capture of comprehensive care of elderly patients. They noted that complete removal and no replacement of this measure will lessen the incentive and urgency for A COs to administer this life saving vaccination, resulting in fewer patients vaccinated, and leading to worsened outcomes and higher costs. Response: We agree on the importance of a pneumonia vaccination measure. However, we believe the burden to submit this measure via the CMS Web Interface and the loss ofNQF endorsement aligns with our goal to be less burdensome for clinicians and ensure measures are still supported by the current clinical guidelines. Furthermore, we acknowledge that pneumonia vaccination is an important preventive clinical intervention, but measure Q 111 does not address current pneumonia vaccination guidelines. We believe maintaining the measure under other collection types to provide an option to select a measure that addresses important population health matter. However, until this measure can be replaced with a measure promoting pneumococcal vaccination, we believe it should not be required to be submitted via the CMS Web Interface. Eligible clinicians submitting Medicare Part B Claims Measure Specifications, eCQM Specifications, MIPS CQMs Specifications are able to select quality measures that are applicable to their specialty that are meaningful to their practice. In the CMS Web Interface, all measures are required; therefore, some eligible clinicians may believe the measure to be burdensome since it does not fully align with the current pneumococcal vaccination schedule. Comment: A few commenters expressed concern that the measures we proposed to remove from the CMS Web Interface would continue to be used in other programs or that they would remain available to report to MIPS via other reporting mechanisms, creating inconsistency in the available measure set by reporting mechanism. Response: We acknowledge that measures proposed for removal from the CMS Web Interface may continue to be required by other programs and available by other collection types. However, removing them from the CMS Web Interface would reduce burden on MIPS groups and ACO participants by removing the requirement that they actively submit the measure performance data through the CMS Web Interface. Specific to ACO participants, ACOs can track these additional metrics in order to participate in the Shared Savings Program and potentially earn shared savings. We note, however, that one of the advantages of clinician participation in a Shared Savings Program ACO is that the ACO reports quality on the clinicians' behalf, reducing clinician burden. We believe that this streamlined approach benefits ACOs in reducing program complexity and enables CMS to make meaningful comparisons on a consistent measure set, across ACOs who are eligible to share in any earned savings or may be responsible for any owed losses, based on that performance. For MIPS groups, we are removing this measure to reduce burden of reporting the required measure set. However, we are retaining this measure through the Medicare Part B Claims Measure Specifications and MIPS CQMs Specifications collection types to allow clinicians an opportunity to report this measure as one of the six measures to meet the quality performance category requirements. Comment: One commenter stated that measure Q 111: Pneumococcal Vaccination Status for Older Adults is aligned with the CMS Meaningful Measures Framework and is a high-impact measure. The commenter did not agree with CMS' concern that the measure is not aligned with ACIP pneumococcal vaccination recommendations. The commenter requested that CMS retain the current pneumococcal vaccination measure until such time as it can be updated with new measure( s ). VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00408 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.225</GPH> amozie on DSK3GDR082PROD with RULES3 Response: We agree that the measure addresses an important population health matter and encourage measure developers to submit an updated measure through the Call for Measures process. Please note that we are retaining this measure in the MIPS program and this substantive change only relates to the removal of the CMS Web Interface data collection method. The removal of the CMS Web Interface was proposed to reduce burden on MIPS groups and ACO participants by removing the requirement that they actively submit the measure performance data through the CMS Web Interface. We maintain the concern that it is not in complete alignment with the ACIP recommendations. The measure specification only requires one dose ever documented, either the PCV13 or PPSV23 vaccine (or both). According to ACIP recommendations, patients should receive both vaccines. The order and timing of the vaccinations depends on certain patient characteristics, and are described in more detail in the ACIP recommendations. Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60243 VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00409 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.226</GPH> amozie on DSK3GDR082PROD with RULES3 Category I Description FINAL ACTION: We are finalizing the changes to measure Qlll as proposed for the 2019 Performance Period and future years. Please note that the following technical changes were also made to this measure: The CMS eCQM ID changed from "CMS127v6" to "CMS127v7." The NQF# changed from "0043" to "N/A" due to loss ofNQF endorsement. These changes were also applied to specialty measure sets in Table Group B where this measure was included. 60244 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations .. n·ta betes: E D3 Cateeory NQF#: Quality#: CMSeCQMID: National Quality Strategy Domain: ~ye Exam Description 0055 117 CMS13lv7 Effective Clinical Care Medicare Part B Claims Measure Specifications, eCQM Specifications, CMS Web Interface Measure Specifications, MIPS CQMs Specifications Percentage of patients 18-75 years of age with diabetes who had a retinal or dilated eye exam by an eye care professional during Current Measure the measurement period or a negative retinal exam (no evidence of retinopathy) in the 12 months prior to the measurement period Description: Modified collection type: Medicare Part B Claims Measure Specifications, eCQM Specifications, MIPS CQMs Specifications Substantive Chanee: National Committee for Quality Assurance Steward: Hieh Priority Measure: No Measure Type: Process We removed the CMS Web Interface Measure Specifications collection type. This measure evaluates a process in the care for the patient. Removal of this measure from the CMS Web Interface Measure Specifications supports our effort to move towards outcome and meaningful measures. In addition, since clinicians are required to report all available CMS Web Interface measures, removing this measure from the CMS Web Interface will reduce the burden of the number of measures a clinician is required to Rationale: report under the CMS Web Interface. This measure is broadly applicable to eligible clinicians participating in the MIPS program using the collection types of Medicare Part B Claims Measure Specifications, MIPS CQMs Specifications, and eCQM specifications. Retaining this measure through the Medicare Part B Claims Measure Specifications, MIPS CQMs Specifications, and eCQM specification collection types allows clinicians to choose this measure as one of the six measures clinicians are generally required to report to meet the quality performance category requirements Comment: One commenter opposed the elimination the CMS Web Interface Measure Specifications collection type for this measure as regular exams are vital to preventing unnecessary vision loss. Current Collection Type: Response: We believe this measure would be burdensome to require all eligible clinicians using the CMS Web Interface to submit this measure. All measures included in the CMS Web Interface are required to be submitted even if the measure may not apply to a particular specialty. We are maintaining the measure under other collection types to provide an option to select a measure that addresses important process in diabetes care. Eligible clinicians submitting Medicare Part B Claims Measure Specifications, eCQM Specifications, MIPS CQMs Specifications are able to select quality measures that are applicable to their specialty that are meaningful to their practice. In the CMS Web Interface, all measures are required, therefore some eligible clinicians may believe the measure to be burdensome. Comment: A few commenters expressed concern that the measures we proposed to remove from the CMS Web Interface would continue to be used in other programs or that they would remain available to report to MIPS via other reporting mechanisms, creating inconsistency in the available measure set by reporting mechanism. Response: We acknowledge that measures proposed for removal from the CMS Web Interface may continue to be required by other programs and available by other collection types. However, removing them from the CMS Web Interface would reduce burden on MIPS groups and ACO participants by removing the requirement that they actively submit the measure performance data through the CMS Web Interface. Specific to ACO participants, A COs can track these additional metrics in order to participate in the Shared Savings Program and potentially earn shared savings. We note, however, that one of the advantages of clinician participation in a Shared Savings Program ACO is that the ACO reports quality on the clinicians' behalf, reducing clinician burden. We believe that this streamlined approach benefits ACOs in reducing program complexity and enables CMS to make meaningful comparisons on a consistent measure set, across ACOs who are eligible to share in any earned savings or may be responsible for any owed losses, based on that performance. For MIPS groups, we are removing this measure to reduce burden of reporting the required measure set. However, we are retaining this measure through the Medicare Part B Claims Measure Specifications and MIPS CQMs Specifications collection types to allow clinicians an opportunity to report this measure as one of the six measures to meet the quality performance category requirements. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00410 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.227</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are finalizing measure Qll7: Diabetes: Eye Exam as proposed for the 2019 Performance Period and future years. Please note that the following technical changes were also made to this measure: The CMS eCQM ID changed from "CMS13lv6" to "CMS13lv7." These changes were also applied to specialty measure sets in Table Group B where this measure was included. Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations Cateeory NQF#: Quality#: CMSeCQMID: N a tiona! Quality Strategy Domain: Current Collection Type: Current Measure Description: Substantive Change: Steward: High Priority Measure: Measure Type: 60245 D.4. Preventive Care and Screenin2: Body Mass Index (BMI) Screenin2 and Follow-Up Plan Description 0421 128 CMS69v7 Community/Population Health Medicare Part B Claims Measure Specifications, eCQM Specifications, CMS Web Interface Measure Specifications, MIPS CQMs Specifications Percentage of patients aged 18 years and older with a BMI documented during the current encounter or during the previous 12 months AND with a BMI outside of normal parameters, a follow-up plan is documented during the encounter or during the previous 12 months of the current encounter. Normal Parameters: Age 18 years and older BMI => 18.5 and< 25 kg/rn2. Modified collection type: Medicare Part B Claims Measure Specifications, eCQM Specifications, MIPS CQMs Specifications Updated the denominator exception logic: for the eCQM Specifications collection type to allow medical reasons for not obtaining the BMI. Centers for Medicare & Medicaid Services No Process We removed the CMS Web Interface Measure Specifications collection type. This measure evaluates a process in the care for the patient. Removal of this measure from the CMS Web Interface Measure Specifications supports our effort to move towards outcome and meaningful measures. In addition, since clinicians are required to report all available CMS Web Interface measures, removing this measure from the CMS Web Interface will reduce the burden of the number of measures a clinician is required to report under the CMS Web Interface. This measure is broadly applicable to eligible clinicians participating in the MIPS program using the collection types of Medicare Part B Claims Measure Specifications, MIPS CQMs Specifications, and eCQM specifications. Retaining this measure through the Medicare Part B Claims Measure Specifications, MIPS CQMs Specifications, and eCQM specification collection types allows clinicians to choose this measure as one of the six measures clinicians are generally required to report to meet the quality performance category requirements. Rationale: We updated the denominator exception logic for the eCQM Specifications collection type to allow medical reasons for not obtaining the BMI. The Technical Expert Panel (TEP) convened by the measure steward recommended adding a medical reason as there could be valid medical reasons for not obtaining the BMI. We agree with the TEP to add a medical exception. There are valid medical reasons that may inhibit the eligible clinicians from obtaining a BMI. Specifically, CMS69v6 has denominator exceptions for medical reasons for not providing the follow-up plan. These exceptions are currently expressed as "Intervention, Order not done" and "Medication, Order not done". The updated measure, CMS69v7, adds an exception to remove patients from the denominator who have a medical reason for not having a BMI performed. This exception was added to account for patients for whom it may be physically difficult to conduct a BMI, such as patients who are unable to stand or for whom their weight exceeds scale limits. This update will provide eligible clinicians the opportunity to exclude patients when there is an appropriate medical reason documented. Comment: One commenter suggested that BMI screening and follow-up is an important metric since weight loss and gain are symptoms of some mental health disorders and patients with serious mental illness face increased risks for obesity and early death from medical co-morbidities as a side-effect of psychotropic medications. One commenter supported the updates to this measure. Another commenter suggested that elimination of this measure would impact the long-term importance of assessing clinician performance related to population health. Response: We agree that obesity-related care is important; however, we believe that this issue will continue to be addressed under several of the measures that remain in the CMS Web Interface and SSP measure set, for example the 30 day all-cause readmission measure, and the hypertension, statin, diabetes measures. Comment: A few commenters expressed concern that the measures we proposed to remove from the CMS Web Interface would continue to be used in other programs or that they would remain available to report to MIPS via other reporting mechanisms, creating inconsistency in the available measure set by reporting mechanism. Response: We acknowledge that measures proposed for removal from the CMS Web Interface may continue to be required by other programs and available by other collection types. However, removing them from the CMS Web Interface would reduce burden on MIPS groups and ACO participants by removing the requirement that they actively submit the measure performance data through the CMS Web Interface. Specific to ACO participants, ACOs can track these additional metrics in order to participate in the Shared Savings Program and potentially earn shared savings. We note, however, that one ofthe advantages of clinician participation in a Shared Savings Program ACO is that the ACO reports quality on the clinicians' behalf, reducing clinician burden. We believe that this streamlined approach benefits ACOs in reducing program complexity and enables CMS to make meaningful comparisons on a consistent measure set, across A COs who are eligible to share in any earned savings or may be responsible for any owed losses, based on that performance. For MIPS groups, we are removing this measure to reduce burden of reporting the required measure set. However, we are retaining this measure through the Medicare Part B Claims Measure Specifications and MIPS CQMs Specifications collection types to allow clinicians an opportunity to report this measure as one ofthe six measures to meet the quality performance category requirements. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00411 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.228</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are finalizing the changes to measure Q128 as proposed for the 2019 Performance Period and future years. Please note that the following technical changes were also made to this measure: The CMS eCQM ID changed from "CMS69v6" to "CMS69v7." These changes were also applied to specialty measure sets in Table Group B where this measure is included. 60246 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations .. Cateeory NQF#: Quality#: CMSeCQMID: National Quality Strategy Domain: Current Collection Type: Current Measure Description: Substantive Change: Steward: Hil!:h Priority Measure: Measure Type: . D50 nco 02Y: Md" e 1ca an dRa d"1at10nPI an o rc are tior M o d erate to Description 0383 144 N/A severe p·am Person and Caregiver-Centered Experience and Outcomes MIPS CQMs Specifications Percentage of patients, regardless of age, with a diagnosis of cancer currently receiving chemotherapy or radiation therapy who report having moderate to severe pain with a plan of care to address pain documented on or before the date of the second visit with a clinician The new numerator is revised to read: Patients for whom a plan of care to address moderate to severe pain is documented on or before the date of the second visit with a clinician. Updated the denominator to clearly state that population for this measure would be linlited to patients who had moderate to severe pain. The new denominator is revised to read: Ail patients, regardless of age, with a diagnosis of cancer currently receiving chemotherapy who report having moderate to severe pain or Ail patients, regardless of age, with a diagnosis of cancer currently receiving radiation therapy. American Society of Clinical Oncology Yes Process We modified the numerator to state that the plan of care for pain management should be documented in the first 2 visits (not at any point during the performance period). The current measure requires the plan of care to be documented at any tinle during the performance period. We modified the denominator to clearly state that the population for this measure would be limited to patients who had moderate to severe pain. Rationale: Pain severity continues to remain largely unaddressed, especially in those patients who have moderate/severe pain. The edits to this measures numerator would ensure that the oncologist documents a plan of care early, so as to ensure that patients who have moderate to severe pain know what pain management options are available to them earlier on when receiving chemotherapy and radiation, and can become engaged early on in their healthcare decisions. The update to the numerator is based on American Society of Clinical Oncology feedback on the measure by Quality Oncology Practice Initiative registry users who realize that the measure should focus on this to ensure quality of life via pain management is improved in cancer patients. Comment: One commenter supported the changes to this measure. Response: We thank the commenter for their support. FINAL ACTION: We are not finalizing the changes to measure Ql44 as proposed for the 2019 Performance Period and future years because, upon reviewing the steward's test results for the proposed numerator and denominator changes, NQF determined that the measure steward's testing data was insufficient. As a result, the NQF has requested that the measure steward retest these changes with sufficient data. Therefore, we will retain the current 2018 numerator and denominator specifications for this measure, as follows: Numerator: Patient visits that included a documented plan of care to address pain Denominator: All visits for patients, regardless of age, with a diagnosis of cancer currently receiving chemotherapy or radiation therapy who report having pain. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00412 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.229</GPH> amozie on DSK3GDR082PROD with RULES3 Please note that, although the proposed substantive changes are not fmalized, the following technical changes were made to this measure for further accuracy based on feedback from the measure steward: The Measure Title was changed from "Medical and Radiation- Plan of Care for Pain" to "Medical and RadiationPlan of Care for Moderate to Severe Pain." This change was applied to specialty measure sets in Table Group 8 where this measure is included. Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60247 D.6. Rheumatoid Arthritis (RA): Tuberculosis Screenin2 Cateeory NQF#: Quality#: CMSeCQMID: National Quality Strategy Domain: Current Collection Type: Current Measure Description: Substantive Change: Description N/A 176 N/A Effective Clinical Care MIPS CQMs Specifications Percentage of patients aged 18 years and older with a diagnosis of rheumatoid arthritis (RA) who have documentation of a tuberculosis (TB) screening performed and results interpreted within 6 months prior to receiving a first course of therapy using a biolo11;ic disease-modifyin11; anti-rheumatic dru11; (DMARD) The new description is revised to read: Percentage of patients aged 18 years and older with a diagnosis of rheumatoid arthritis (RA) who have documentation of a tuberculosis (TB) screening performed and results interpreted within 12 months prior to receiving a first course of therapy using a biologic disease-modifying anti-rheumatic drug (DMARD). The new numerator is revised to read: Patients for whom a TB screening was performed and results interpreted within 12 months prior to receiving a first course of therapy using a biologic DMARD. American College of Rheumatology Steward: No Hieh Priority Measure: Process Measure Type: We updated to the numerator to require the TB screening 12 months prior to the first biologic treatment rather than 6 months as currently stated. The measure steward believes this measure should be more in line with the specifications found in a similar measure developed by the American College of Rheumatology (ACR) and endorsed by the National Quality Forum (NQF). In creating its version of this measure, the ACR conducted an extensive development and review process. The measure was built by a panel of rheumatology experts, in conjunction with the ACR, based on quality of care guidelines and broad reviews of relevant research. Upon completion, the measure was shared with thousands of rheumatology clinicians across the U.S. for public Rationale: comment. Following the comment period, the measure was updated appropriately based on the feedback received, then rigorously tested to ensure reliability and validity. The measure, along with the results of the testing, was submitted to the NQF for review and obtained trial endorsement. We typically prefer the use ofNQF endorsed measures over measures that lack endorsement. However, NQF endorsement is not a requirement for measures to be considered for MIPS if the measure has an evidence-based focus. We believe this measure revision from tuberculosis screening from 6 months to 12 months can be supported by evidence and is an important measure to ensure proper tuberculosis screening for rheumatoid arthritis patients. We did not receive specific comments regarding these measure changes. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00413 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.230</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are finalizing the changes to measure Q176 as proposed for the 2019 Performance Period and future years. 60248 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations Cate2orv NQF#: Quality#: CMSeCQMID: National Quality Strategy Domain: Current Collection Type: Current Measure Description: D.7. Rheumatoid Arthritis (RA): Periodic Assessment of Disease Activity Description N/A 177 N/A Effective Clinical Care MIPS CQMs Specifications Percentage of patients aged 18 years and older with a diagnosis of rheumatoid arthritis (RA) who have an assessment and classification of disease activity within 12 months. The new numerator is revised to read: Patients with disease activity assessed by an ACR-endorsed rheumatoid arthritis disease activity measurement tool classified into one of the following categories: remission, low, moderate or high, at least >=50 percent of total number of outpatient RA encounters in the measurement year. Substantive Change: Steward: Hieh Priority Measure: Measure Type: The new definition is revised to read: Assessment and Classification of Disease Activity- Assesses if physicians are utilizing a standardized, systematic approach for evaluating the level of disease activity for each patient at least for >=50 percent of total number of outpatient RA encounters. The scales/instruments listed are the ACR-endorsed tools that should be used to define activity level and cut-off points: -Clinical Disease Activity Index (CDAI) -Disease Activity Score with 28-joint counts (erythrocyte sedimentation rate or C-reactive protein) (DAS-28) -Patient Activity Scale (PAS) -Patient Activity Score-II (PAS-II) -Routine Assessment of Patient Index Data with 3 measures (RAPID 3) -Simplified Disease Activity Index (SDAI) A result of any kind qualifies for meeting numerator performance. American College of Rheumatology No Process We updated the numerator to change the requirement to assess disease activity from once a year to "2:: 50 percent of encounters in the measurement year" and to change the use of any standardized tool to only use ACR-endorsed tools. Currently, the measure is only required to be submitted once per performance period. The current measure identifies tools that are available, but allows eligible clinicians to utilize tools not listed within the specification. The changes add a considerable degree of specificity to quality measure 177 by ( 1) limiting options for disease activity measures to those that have been found to be valid through a rigorous ACR process, and (2) changing the frequency of assessment to include a majority of clinical encounters for RA, since this approach would be consistent with current guidelines regarding treating to a pre-specified target. Rationale: The ACR developed recommendations for the use ofRA disease activity measures in clinical practice. And after thorough evaluation of around 63 available measures, ACR recommends the following 6 measures: CDAI, DAS28 (ESR or CRP), PAS, PAS-II, RAPID-3, and SDAI as ACR-endorsed RA disease activity measures to be used in clinical practice. Many of these tools are available free of charge. The tools were selected to ensure a comprehensive and standardized approach to assess disease activity for rheumatoid arthritis. Given this evidence, the measure steward believes this measure should be updated to be more in line with the specifications found in similar measures developed by ACR and endorsed by NQF. We agree with the revision to promote utilization of the most current guidelines that have been developed by the panel of rheumatology experts. We typically prefer the use ofNQF endorsed measures over measures that lack endorsement. Disease activity assessment is imperative to development of an appropriate treatment plan. Revising the numerator to require a more frequent assessment supports development of a more effective treatment plan. We support the use of standardized tools to assess disease activity so the score can be standardized and comparable among eligible clinicians. Comment: One commenter supported the revisions to measure Q177: Rheumatoid Arthritis (RA) Periodic Assessment of Disease Activity as the changes would limit the measurement tools available to clinicians for assessing disease activity levels only to those that have been found to be valid through the American College of Rheumatology process. The change to increase the frequency of disease activity assessment from only once per year to "at least 50 percent or more of clinical encounters for RA" would be consistent with clinical guidelines for RA disease activity assessment and supported those changes. A narrower list of ACR-endorsed measurement tools will create measurement uniformity for clinicians, can help establish clinical consensus in how disease activity levels should be defined, and promotes consistent outcomes measurement across RA patients. Response: We agree this would align would the current guideline and provide standardized approach to assess rheumatoid arthritis. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00414 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.231</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are finalizing the changes to measure Q177 as proposed for the 2019 Performance Period and future years. Please note that the following technical changes were also made to this measure for further accuracy based on feedback from the measure steward: The Measure Description was updated to "Percentage of patients aged 18 years and older with a diagnosis of rheumatoid arthritis (RA) who have an assessment of disease activity at 2::50 percent of encounters for RA for each patient during the measurement year." These changes were also applied to specialty measure sets in Table Group B where this measure is included. Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60249 D.8. Optimizing Patient Exposure to Ionizing Radiation: Appropriateness: Follow-up CT Imaging for Incidentally D e t ect e d P u Imonary N o d u Ies A ccor d'm~ t o R ecommen d e d G m'd e I'mes Description Cateeory NQF#: N/A Quality#: 364 CMSeCQMID: N/A National Quality Strategy Communication and Care Coordination Domain: MIPS CQMs Specifications Current Collection Type: Percentage offmal reports for computed tomography (CT) imaging studies of the thorax for patients aged 18 years and older with Current Measure documented follow-up recommendations for incidentally detected pulmonary nodules (for example, follow-up CT imaging Description: studies needed or that no follow-up is needed) based at a minimum on nodule size AND patient risk factors. Updated the denominator: To patients 35 years and older. Updated denominator exclusions: Added heavy tobacco smokers Updated denominator exceptions: To include medical reasons. Updated numerator: Includes a recommended interval and modality for follow-up. Substantive Change: Steward: Hieh Priority Measure: Measure Type: Rationale: The new description is revised to read: Percentage of final reports for CT imaging studies with a finding of an incidental pulmonary nodule for patients aged 35 years and older that contain an impression or conclusion that includes a recommended interval and modality for follow-up [(for example, type of imaging or biopsy) or for no follow-up, and source of recommendations (for example, guidelines such as Fleischner Society, American Lung Association, American College of Chest Physicians). American College of Radiology Yes Process We updated the measure description and denominator from 18 years and older to 35 years and older. We also updated the numerator to include a recommended interval and modality for follow-up. The revised measure assesses final reports for CT imaging studies with a finding of an incidental pulmonary nodule for patients aged 35 years and older that contain an impression or conclusion that includes a recommended interval and modality for follow-up [(for example, type of imaging or biopsy) or for no follow-up, and source of recommendations (for example, guidelines such as Fleischner Society, American Lung Association, American College of Chest Physicians)]. The current measure specification does not allow a denominator exclusion for heavy smokers. A new denominator exclusion is included for heavy tobacco smokers who qualifY for lung cancer screening. Furthermore, the current denominator exception does not account for the indication of a modality. A new denominator exception for medical reasons for not including a recommended interval and modality for follow-up. The changes add specificity to this measure and ensure the appropriate patient population is being targeted for this measure by: (1) updating the numerator quality action to specifY a recommended interval and modality for follow-up; (2) specifYing additional denominator exclusions and exceptions; and (3) changing the intended patient population (to 35 years and older) as supported by an update to clinical guidelines. We agree with the revision to promote utilization of the most current guidelines. It creates a more robust measure that defines the required clinical action to the narrowed patient population. We also agree with the addition specific denominator exceptions and denominator exclusions to promote consistent data among eligible clinicians. We did not receive specific comments regarding these measure changes. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00415 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.232</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are finalizing the changes to measure Q364 as proposed for the 2019 Performance Period and future years. 60250 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations .. D9 D epressiOn R emission at Tweve M onth s Cate2ory NQF#: Quality#: CMSeCQMID: National Quality Strategy Domain: Current Collection Type: Current Measure Description: Description 0710 370 CMS159v7 Effective Clinical Care eCQM Specifications, CMS Web Interface Measure Specifications, MIPS CQMs Specifications The percentage of patients 18 years of age and or older with major depression or dysthymia who reached remission 12 months (+/- 30 days)after an index visit The new description is revised to read: The percentage of adolescent patients 12 to 17 years of age and adult patients 18 years of age or older with major depression or dysthymia who reached remission 12 months(+/- 60 days) after an index event date. The new denominator is revised to read: Adolescent patients 12 to 17 years of age with a diagnosis of major depression or Substantive Change: dysthymia and an initial PHQ-9 or PHQ-9M score greater than nine during the index event. The new numerator is revised to read: Adolescent patients aged 12 to 17 years of age who achieved remission at 12 months as demonstrated by a 12-month (+/- 60 days) PHQ-9 or PHQ-9M score ofless than five. Minnesota Community Measurement (MNCM) Steward: Yes Hil!h Priority Measure: Outcome Measure Type: We added adolescents to the denominator via stratification and references to the PHQ-9M, which is specific for adolescents. The patient population has been revised to include patients 12 years of age and older, when previously only included patients over the age of 18. The score to determine denominator eligibility was based on the PHQ-9 assessment, this was expanded to include the PHQ-9M to accommodate the expanded age with age appropriate assessment tools. The measure steward worked in collaboration Rationale: with NCQA, who requested a consideration of incorporating adolescents into the existing depression measures. We agreed with the expansion of the denominator to include the adolescent patient population. Depression assessment is a clinically relevant and important topic to address among adolescents. We appreciated the collaboration among the stakeholders to broaden the measure. Comment: One commenter noted the benefits and challenges associated with reporting the Depression Remission at 12 Months measure. While its inclusion in MIPS provides a more comprehensive measure set from which clinicians can choose to report, the commenter noted it carries a significant data collection burden. A second commenter stated that measure Q370 has been a challenge for academic medical centers is the depression remission measure. The depression remission measure (MH-1) measures the number of patients with major depression as defined as an initial PHQ-9 score> 9 who demonstrate remission at 12 months as defined as a PHQ-9 score <5. The requirement for PHQ-9 use for evaluating patients combined with a follow-up evaluation is problematic for many large group practices. The measure must be recorded for 248 patients, a very difficult bar for large multi-specialty group practices which refer patients for treatment and follow-up to psychiatrists if they have a PHQ-9. The measure seems to be designed for group practices that do not have this type of referral pattern. This is just one example of practice pattern differences between large academic medical groups and small and or/ rural practices. The commenter requested that the measure be removed, and that CMS determine if there may be other measures related to depression that would be more appropriate to use in the MIPS program. Response: We believe this measure aligns with our policy to maintain meaningful measures within the program. Mental health issues have become prevalent in the nation and we believe it is critical to maintain measures that support improvement in mental health especially since our proposal is to expand this measure to adolescents. For this reason, we believe the benefit of measuring outcomes, as well as providing a more comprehensive measure set for the eligible clinician to report outweighs the data collection burden. In response to the commenter concern regarding the workflow of a large academic medical centers, the PHQ-9 derived from the psychiatrist could be used to determine remission as long as it is documented within the medical record. This would require communication and care coordination between the referring clinician and psychiatrist. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00416 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.233</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are finalizing the changes to measure Q370 as proposed for the 2019 Performance Period and future years. Please note that the following technical changes were also made to this measure: The CMS eCQM ID changed from "CMS159v6" to "CMS159v7." These changes were also applied to specialty measure sets in Table Group B where this measure is included. Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60251 DlO D epress10n UT t1 IZation o f t he PHQ-9T 00 Cateeory NQF#: Quality#: CMSeCQMID: National Quality Strategy Domain: Current Collection Type: Current Measure Description: Description 0712 371 CMS160v7 Effective Clinical Care eCQM Specifications The percentage of patients age 18 and older with the diagnosis of major depression or dysthymia who have a completed PHQ-9 during each applicable 4-month period in which there was a qualifying visit. The new description is revised to read: The percentage of adolescent patients (12 to 17 years of age) and adult patients (18 years of age or older) with a diagnosis of major depression or dysthymia who have a completed PHQ-9 or PHQ-9M tool during the measurement period. The new denominator is revised to read: Adolescent patients (12 to 17 years of age) and adult patients (18 years of age or Substantive Change: older) with a diagnosis of major depression or dysthymia. The new numerator is revised to read: Adolescent patients (12 to 17 years of age) and adult patients (18 years of age or older) included in the denominator who have at least one PHQ-9 or PHQ-9M tool administered and completed during a 4-month measurement period. Minnesota Community Measurement (MNCM) Steward: No High Priority Measure: Process Measure Type: We added adolescents to the denominator via stratification and references to the PHQ-9M for both denominator and numerator, which is specific for adolescents. The patient population has been revised to include patients 12 years of age and older, when previously only included patients over the age of 18. The measure steward worked in collaboration with NCQA, who requested a Rationale: consideration of incorporating adolescents into the existing depression measures. We agreed with the expansion ofthe denominator to include the adolescent patient population. Depression assessment is a clinically relevant and important topic to address among adolescents. We appreciated the collaboration among the stakeholders to broaden the measure. We did not receive specific comments regarding these measure changes. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00417 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.234</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are finalizing the changes to measure Q371 as proposed for the 2019 Performance Period and future years. Please note that the following technical changes were also made to this measure: The CMS eCQM ID changed from "CMS160v6" to "CMS160v7." These changes were also applied to specialty measure sets in Table Group B where this measure is included. 60252 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations DllMI e anoma R eportm2 Cate2ory NQF#: Quality#: CMSeCQMID: National Quality Strategy Domain: Current Collection Type: Current Measure Description: Description N/A 397 N/A Communication and Care Coordination Medicare Part B Claims Measure Specifications, MIPS CQMs Specifications Pathology reports for primary malignant cutaneous melanoma that include the pT category and a statement on thickness and ulceration and for pTl, mitotic rate. Substantive Change: The new numerator is revised to read: Pathology reports for primary malignant cutaneous melanoma that include the pT category and a statement on thickness, ulceration and mitotic rate. College of American Pathologists Steward: Yes High Priority Measure: Process Measure Type: We updated the numerator to include mitotic rate for all pT categories. The current measure specification only requires a statement the mitotic rate for pTl. The American Joint Committee on Cancer's Melanoma Expert Panel strongly recommends that mitotic rate be assessed and recorded for all primary melanomas, although it is not used for Tl staging in the eighth edition. The mitotic rate will likely be an important parameter for inclusion in the future development of prognostic models applicable to Rationale: individual patients. Although it is not included in the Tl subcategory criteria, mitotic activity in Tl melanomas also has been associated with an increased risk of sentinel lymph node metastasis. We agreed with the addition of mitotic rate assessment for all primary melanomas. This creates valuable clinical information to the eligible clinician in order to create an effective treatment plan specific to the melanoma. We did not receive specific comments regarding these measure changes. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00418 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.235</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are finalizing the changes to measure Q397 as proposed for the 2019 Performance Period and future years. Please note that the following technical changes were also made to this measure for further accuracy based on feedback from the measure steward: The Measure Description was updated to "Pathology reports for primary malignant cutaneous melanoma that include the pT category and a statement on thickness, ulceration and mitotic rate." These changes were also applied to specialty measure sets in Table Group B where this measure is included. Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations D 12 Psonas1s: Catei!OfY NQF#: Quality#: CMSeCQMID: National Quality Strategy Domain: Current Collection Type: Current Measure Description: Substantive Change: Steward: High Priority Measure: Measure Type: 60253 . Md' crmica · IResponse to ssystemic e Ications Description NIA 410 NIA Person and Caregiver-Centered Experience and Outcomes MIPS CQMs Specifications Percentage of psoriasis vulgaris patients receiving oral systemic or biologic therapy who meet minimal physician-or patientreported disease activity levels. It is implied that establishment and maintenance of an established minimum level of disease control as measured by physician-and/or patient-reported outcomes will increase patient satisfaction with and adherence to treatment. The new description is revised to read: Percentage of psoriasis vulgaris patients receiving systemic medication who meet minimal physician-or patient- reported disease activity levels. It is implied that establishment and maintenance of an established minimum level of disease control as measured by physician-and/or patient-reported outcomes will increase patient satisfaction with and adherence to treatment The new denominator is revised to read: All patients with a diagnosis of psoriasis vulgaris and treated with a systemic medication. The new numerator is revised to read: Patients who have a documented physician global assessment (PGA; 5-point OR 6point scale), body surface area (BSA), psoriasis area and severity index (PASI) and/or dermatology life quality index (DLQI) that meet any one of the below specified benchmarks. American Academy of Dermatology Yes Outcome We updated the measure title, description and denominator to expand the measure to include systemic medications that are administered both orally and subcutaneously. The measure still includes biologics rather than only oral and biologic medications. The patient population includes those diagnosed with psoriasis vulgaris receiving systemic medications that are administered both orally and subcutaneously or biologic therapy who meet minimal physician-or patient- reported disease activity levels. In addition, the numerator is being expanded to include the 5-point PGA scale as an additional benchmark. The current numerator allow the use ofPGA; 6-point scale), body surface area (BSA), psoriasis area and severity index (PASI) and/or dermatology life quality index (DLQI) to assess clinical response. Rationale: The measure steward believes the update to allow all systemic medications is relevant as they have deemed them to all apply to the measure. Based on recent literature, there is a strong correlation in how the 5-point scale is used like the 6-point PGA scale, resulting in comparative results. This scale is requested to be added to allow clinicians a shorter scale to choose from which would be more user-friendly in a clinical setting. We agreed with the expansion of the denominator to include all systemic medications, not limited to oral systemic or biologic therapy. Including systemic medications administered subcutaneously provides an additional opportunity to assess effective outcomes this treatment option. We agreed with the 5-point PGA scale to allow an additional tools to assess psoriasis outcomes. Comment: Several commenters supported the measure expansion for Q410: Psoriasis: Clinical Response to Systemic Medications to systemic drugs that are administered both orally and subcutaneously. Psoriasis had been an underrepresented clinical category within the MIPS measure set in recent years, and the expansion of this measure creates additional opportunities to demonstrate the effectiveness of new treatment options. Response: We thank the commenters for their support of measure Q41 0: Psoriasis: Clinical Response to Systemic Medications. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00419 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.236</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are finalizing the changes to measure Q410 as proposed for the 2019 Performance Period and future years. We are finalizing this measure as a MIPS CQMs Specification only. This measure will not be available as a Medicare Part B Claims Measure Specification as it is not analytically feasible for this collection type. Please note that the following technical changes were also made to this measure for further accuracy based on feedback from the measure steward: The Measure Title was changed from "Psoriasis: Clinical Response to Oral Systemic or Biologic Medications" to "Psoriasis: Clinical Response to Systemic Medications." These changes were applied to specialty measure sets in Table Group B where this measure is included. 60254 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations D13 D epress10n R emissiOn at s·IX M onth s Cate2ory NQF#: Quality#: CMSeCQMID: National Quality Strategy Domain: Current Collection Type: Current Measure Description: Description 0711 411 N/A Effective Clinical Care MIPS CQMs Specifications The percentage of patients 18 years of age or older with major depression or dysthymia who reached remission 6 months (+/- 30 days) after an index visit. The new description is revised to read: The percentage of adolescent patients 12 to 17 years of age and adult patients 18 years of age or older with major depression or dysthymia who reached remission 6 months (+/- 60 days) after an index event date. The new denominator is revised to read: Submission Criteria 1: Adolescent patients 12 to 17 years of age with a diagnosis of major depression or dysthymia and an initial PHQ-9 or PHQ-9M score greater than nine during the index event. Submission Criteria 2: Adult patients 18 years of age or older with a diagnosis of major depression or dysthymia and an initial PHQ-9 or PHQ-9M score 11;reater than nine durin11; the index event. Minnesota Community Measurement Steward: Hi!!h Priority Measure: Yes Outcome Measure Type: We added adolescents to denominator via stratification and references to the PHQ-9M which is specific for adolescents. The patient population has been revised to include patients 12 years of age and older, when previously only included patients over the age of 18. The score to determine denominator eligibility was based on the PHQ-9 assessment, this was expanded to include the PHQ-9M to accommodate the expanded age with age appropriate assessment tools. The measure steward worked in Rationale: collaboration with NCQA, who requested a consideration of incorporating adolescents into the existing depression measures. We agreed with the expansion of the denominator to include the adolescent patient population. Depression assessment is a clinically relevant and important topic to address among adolescents. We appreciated the collaboration among the stakeholders to broaden the measure. We did not receive specific comments regarding these measure changes. Substantive Change: VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00420 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.237</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are finalizing the changes to measure Q411 as proposed for the 2019 Performance Period and future years. Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60255 D.14. Emergency Medicine: Emergency Department Utilization ofCT for Minor Blunt Head Trauma for Patients Aged 18 Years and Older Cate2ory NQF#: Quality#: CMSeCQMID: National Quality Strategy Domain: Current Collection Type: Current Measure Description: Substantive Change: Steward: Hi2h Priority Measure: Measure Type: Description NIA 415 NIA Efficiency and Cost Reduction Medicare Part B Claims Measure Specifications, MIPS CQMs Specifications Percentage of emergency department visits for patients aged 18 years and older who presented within 24 hours of a minor blunt head trauma with a Glasgow Coma Scale (GCS) score of 15 and who had a head CT for trauma ordered by an emergency care provider who have an indication for a head CT Updated the measure description and denominator to remove the requirement of a patient presenting to the emergency department within 24 hours of a minor blunt head trauma, as well as remove the requirement to document a GCS of 15. The new description is revised to read: Percentage of emergency department visits for patients aged 18 years and older who presented with a minor blunt head trauma who had a head CT for trauma ordered by an emergency care clinician who have an indication for a head CT. The new denominator is revised to read: All emergency department visits for patients aged 18 years and older who presented with a minor blunt head trauma who had a head CT for trauma ordered by an emergency care provider Updated the numerator: To indicate the GCS score less than 15 is an appropriate indication for a head CT. The new definition within the numerator is revised to include a GSC score less than 15. American College of Emergency Physicians (ACEP) Yes Efficiency We updated to the measure description and denominator to remove the requirement of a patient presenting to the emergency department within 24 hours of a minor blunt head trauma, as well as remove the requirement to document a GCS of 15. We updated the numerator to indicate the GCS score less than 15 is an appropriate indication for a head CT. The new description is revised to read: Percentage of emergency department visits for patients aged 18 years and older who presented with a minor blunt head trauma who had a head CT for trauma ordered by an emergency care provider who have an indication for a head CT. Rationale: Based on feedback from the measure steward, this measure is appropriate for all minor blunt head traumas, regardless of when they occurred in relation to presentation to the ED. Additionally, in order to better align the measure with the evidence base and guidelines supporting the measure, the measure steward determined that the GCS of <15 data element would be more accurately included as an appropriate indication for ordering a head CT, so this has been relocated to the numerator defmition. We agreed with the recommendation and accept the revision as this promotes utilization of the most current guidelines to determine imaging requirements based on the documented GCS. We did not receive specific comments regarding these measure changes. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00421 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.238</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are finalizing the changes to measure Q415 as proposed for the 2019 Performance Period and future years. 60256 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations D.15. Emergency Medicine: Emergency Department Utilization of CT for Minor Blunt Head Trauma for Patients Aged 2 th roug1h 17Years Cate2ory NQF#: Quality#: CMSeCQMID: National Quality Strategy Domain: Current Collection Type: Current Measure Description: Substantive Change: Steward: Hi2h Priority Measure: Measure Type: Description N/A 416 N!A Efficiency and Cost Reduction Medicare Part B Claims Measure Specifications, MIPS CQMs Specifications Percentage of emergency department visits for patients aged 2 through 17 years who presented within 24 hours of a minor blunt head trauma with a Glasgow Coma Scale (GCS) score of 15 and who had a head CT for trauma ordered by an emergency care provider who are classified as low risk according to the Pediatric Emergency Care Applied Research Network (PECARN) prediction rules for traumatic brain injury Updated denominator: To remove the requirement of a patient presenting to the emergency department within 24 hours of a minor blunt head trauma, as well as remove the requirement to document a GCS of 15. The measure description is revised to read: Percentage of emergency department visits for patients aged 2 through 17 years who presented with a minor blunt head trauma who had a head CT for trauma ordered by an emergency care provider who are classified as low risk according to the Pediatric Emergency Care Applied Research Network (PECARN) prediction rules for traumatic brain injury. Updated the numerator: To indicate the GCS score Jess than 15 is an appropriate indication for a head CT. American College of Emergency Physicians Yes Efficiency We updated the measure description and denominator to remove the requirement of a patient presenting to the emergency department within 24 hours of a minor blunt head trauma, as well as remove the requirement to document a GCS of 15. We updated the numerator to indicate the GCS score less than 15 is an appropriate indication for a head CT. Based on feedback from the measure steward, this measure is appropriate for all minor blunt head traumas, regardless of when they occurred in relation to presentation to the ED. Additionally, in order to better align the measure with the evidence base and guidelines supporting the measure, ACEP physician leaders determined that the GCS of <15 data element would be more accurately included as an appropriate indication for ordering a head CT, so this has been relocated to the numerator definition. We agreed with the revision as this promotes utilization of the most current guidelines to determine imaging requirement based on the documented GCS. We did not receive specific comments regarding these measure changes. Rationale: VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00422 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.239</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are finalizing the changes to measure Q416 as proposed for the 2019 Performance Period and future years. Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60257 . . hKnee I mpa1rments D 16 F unct10na IStatus Ch ange fior p atlents wit Cate2ory NQF#: Quality#: CMSeCQMID: National Quality Strategy Domain: Current Collection Type: Current Measure Description: Description 0422 217 N/A Communication and Care Coordination MIPS CQMs Specifications A self-report measure of change in functional status for patients 14 yeart with knee impairments. The change in functional status (FS) assessed using FOTO's (knee) PROM (patient-reported outcomes measure) is adjusted to patient characteristics known to be associated with FS outcomes (risk adjusted) and used as a performance measure at the patient level, at the individual clinician, and at the clinic level to assess quality Updated the denominator to allow coding for chiropractors and outpatient eligible clinicians. Substantive Change: The new denominator is revised to expand to: Physician Denominator Criteria and Chiropractic Care Denominator Criteria. Focus on Therapeutic Outcomes, Inc. Yes Patient Reported Outcome We expanded the denominator to allow coding for chiropractors and outpatient eligible clinicians. The current measure only includes coding to support physical and occupational therapists. The measure steward has recommended expanding the denominator to include other types of eligible clinicians providing outpatient and chiropractic services. Physical functional Rationale: status is relevant to a broad spectrum of specialties in order to assess the effectiveness of a treatment plan. We agreed with the recommendation and are proposing the expansion as it allows a broader spectrum of eligible clinicians the opportunity to submit outcome measures. Comment: Two commenters supported the substantive change proposed for measure Q217: Functional Status Change for Patients with Knee Impairments measure by allowing coding for chiropractic clinicians but emphasized that unless chiropractors are reimbursed for CPT code 98943 which covers extraspinal, one or more regions (currently NOT covered by Medicare), the current three codes will not apply to this measure. Steward: High Priority Measure: Measure Type: Response: This measure can only be submitted utilizing the MIPS CQMs Specifications, which allows all payer data to be submitted, not just Medicare. Therefore, chiropractors utilizing CPT code 98943 can include those patients in the denominator for this measure. Specific Medicare reimbursement for this code would not preclude the eligible clinician from submitting this measure. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00423 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.240</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are finalizing changes to measure Q217 as proposed for the 2019 Performance Period and future years. Please note that the following technical changes were also made to this measure for further accuracy based on feedback from the measure steward: The Measure Description was updated to "A patient-reported outcome measure of risk-adjusted change in functional status for patients aged 14 years+ with knee impairments. The change in functional status (FS) is assessed using the Knee FS patient-reported outcome measure (PROM) (©Focus on Therapeutic Outcomes, Inc.). The measure is adjusted to patient characteristics known to be associated with FS outcomes (risk adjusted) and used as a performance measure at the patient level, at the individual clinician, and at the clinic level to assess quality. The measure is available as a computer adaptive test, for reduced patient burden, or a short form (static survey)." The Measure Type was changed from "Outcome" to "Patient Reported Outcome." These changes were applied to specialty measure sets in Table Group B where this measure is included. (Please note that these technical changes were erroneously characterized as substantive changes in the proposed rule.) 60258 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations D 17 F unct10na IS tatus Ch an2e tior p at1ents withHOIP I mpa1rments 0 Cate2orv NQF#: Quality#: CMSeCQMID: National Quality Strategy Domain: Current Collection Type: Current Measure Description: 0 Description 0423 218 N/A Communication and Care Coordination MIPS CQMs Specifications A self-report measure of change in functional status (FS) for patients 14 years+ with hip impairments. The change in functional status (FS) assessed using FOTO's (hip) PROM (patient- reported outcomes measure) is adjusted to patient characteristics known to be associated with FS outcomes (risk adjusted) and used as a performance measure at the patient level, at the individual clinician, and at the clinic level to assess quality Updated the denominator to allow coding for chiropractors and outpatient eligible clinicians. Substantive Change: The new denominator is revised to expand to: Physician Denominator Criteria and Chiropractic Care Denominator Criteria. Focus on Therapeutic Outcomes, Inc. Yes Patient Reported Outcome We expanded the denominator to allow coding for chiropractors and outpatient eligible clinicians. The current measure only includes coding to support physical and occupational therapists. The measure steward has recommended expanding the denominator to include other types of eligible clinicians providing outpatient and chiropractic services. Physical functional Rationale: status is relevant to a broad spectrum of specialties in order to assess the effectiveness of a treatment plan. We agreed with the recommendation and are proposing the expansion as it allows a broader spectrum of eligible clinicians the opportunity to submit outcome measures. Comment: Two commenters supported the substantive change proposed for measure Q218: Functional Status Change for Patients with Hip Impairments measure by allowing coding for chiropractic clinicians but emphasized that unless chiropractors are reimbursed for CPT code 98943 which covers extraspinal, one or more regions (currently NOT covered by Medicare), the current three codes will not apply to this measure. Steward: High Priority Measure: Measure Type: Response: This measure can only be submitted utilizing the MIPS CQMs Specifications, which allows all payer data to be submitted not just Medicare. Therefore, chiropractors utilizing CPT code 98943 can include those patients in the denominator for this measure. Specific Medicare reimbursement for this code would not preclude the eligible clinician from submitting this measure. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00424 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.241</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are finalizing the changes to measure Q218 as proposed for the 2019 Performance Period and future years. Please note that the following technical changes were also made to this measure for further accuracy based on feedback from the measure steward: The Measure Description was updated to "A patient-reported outcome measure of risk-adjusted change in functional status for patients 14 years+ with hip impairments. The change in functional status (FS) is assessed using the Hip FS patient-reported outcome measure (PROM) (©Focus on Therapeutic Outcomes, Inc.). The measure is adjusted to patient characteristics known to be associated with FS outcomes (risk adjusted) and used as a performance measure at the patient level, at the individual clinician, and at the clinic level to assess quality. The measure is available as a computer adaptive test, for reduced patient burden, or a short form (static survey)." The Measure Type was changed from "Outcome" to "Patient Reported Outcome." These changes were applied to specialty measure sets in Table Group B where this measure is included. (Please note that these technical changes were erroneously characterized as substantive changes in the proposed rule.) Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60259 . . hLower L eg, F oot or A n kle I mpa1rments D 18 F unctiona IStatus Ch ange ~or p at1ents wit Cate2ory NQF#: Quality#: CMSeCQMID: National Quality Strategy Domain: Current Collection Type: Current Measure Description: Description 0424 219 N/A Communication and Care Coordination MIPS CQMs Specifications A self-report measure of change in functional status (FS) for patients 14 years+ with foot and ankle impairments. The change in functional status (FS) assessed using FOTO's (foot and ankle) PROM (patient reported outcomes measure) is adjusted to patient characteristics known to be associated with FS outcomes (risk adjusted) and used as a performance measure at the patient level, at the individual clinician, and at the clinic level to assess quality Updated the denominator to allow coding for chiropractors and outpatient eligible clinicians. Substantive Change: The new denominator is revised to expand to: Physician Denominator Criteria and Chiropractic Care Denominator Criteria. Focus on Therapeutic Outcomes, Inc. Yes Patient Reported Outcome We expanded the denominator to allow coding for chiropractors and outpatient eligible clinicians. The current measure only includes coding to support physical and occupational therapists. The measure steward has recommended expanding the denominator to include other types of eligible clinicians providing outpatient and chiropractic services. Physical functional Rationale: status is relevant to a broad spectrum of specialties in order to assess the effectiveness of a treatment plan. We agree with the recommendation and are proposing the expansion as it allows a broader spectrum of eligible clinicians the opportunity to submit outcome measures. Comment: Two commenters supported the substantive change proposed for the Q219: Functional Status Change for Patients with Foot or Ankle Impairments measure by allowing coding for chiropractic clinicians but emphasized that unless chiropractors are reimbursed for CPT code 98943 which covers extraspinal, one or more regions (currently NOT covered by Medicare), the current three codes will not apply to this measure. Steward: Hi!!h Priority Measure: Measure Type: Response: This measure can only be submitted utilizing the MIPS CQMs Specifications, which allows all payer data to be submitted not just Medicare. Therefore, chiropractors utilizing CPT code 98943 can include those patients in the denominator for this measure. Specific Medicare reimbursement for this code would not preclude the eligible clinician from submitting this measure. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00425 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.242</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are finalizing the changes to measure Q219 as proposed for the 2019 Performance Period and future years. Please note that the following technical changes were also made to this measure for further accuracy based on feedback from the measure steward: The Measure Title was changed from "Functional Status Change for Patients with Foot or Ankle Impairments" to "Functional Status Change for Patients with Lower Leg, Foot or Ankle Impairments". The Measure Description was updated to "A patient-reported outcome measure of risk-adjusted change in functional status for patients 14 years+ with foot, ankle and lower leg impairments. The change in functional status (FS) assessed using the Foot/Ankle FS patient-reported outcome measure (PROM) (©Focus on Therapeutic Outcomes, Inc.). The measure is adjusted to patient characteristics known to be associated with FS outcomes (risk adjusted) and used as a performance measure at the patient level, at the individual clinician, and at the clinic level to assess quality. The measure is available as a computer adaptive test, for reduced patient burden, or a short form (static survey)." The Measure Type was changed from "Outcome" to "Patient Reported Outcome." These changes were also applied to specialty measure sets in Table Group B where this measure is included. (Please note that these technical changes were erroneously characterized as substantive changes in the proposed rule.) 60260 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations . . hL ow Bac klmpa1rments D 19 F unctiOn a IStatus Ch an2e ~or p atlents wit Catel!orv NQF#: Quality#: CMSeCQMID: National Quality Strategy Domain: Current Collection Type: Current Measure Description: Description 0425 220 N/A Communication and Care Coordination MIPS CQMs Specifications A self-report outcome measure of change in functional status for patients 14 years+ with lumbar impairments. The change in functional status (FS) assessed using FOTO (lumbar) PROM (patient reported outcome measure) is adjusted to patient characteristics known to be associated with FS outcomes (risk adjusted) and used as a performance measure at the patient level, at the individual clinician, and at the clinic level by to assess quality Updated the denominator to allow coding for chiropractors and outpatient eligible clinicians. Substantive Change: The new denominator is revised to expand to: Physician Denominator Criteria and Chiropractic Care Denominator Criteria. Focus on Therapeutic Outcomes, Inc. Yes Patient Reported Outcome We expanded the denominator to allow coding for chiropractors and outpatient eligible clinicians. The current measure only includes coding to support physical and occupational therapists. The measure steward has recommended expanding the denominator to include other types of eligible clinicians providing outpatient and chiropractic services. Physical functional Rationale: status is relevant to a broad spectrum of specialties in order to assess the effectiveness of a treatment plan. We agreed with the recommendation and are proposing the expansion as it allows a broader spectrum of eligible clinicians the opportunity to submit outcome measures. Comment: Two commenters supported the substantive change proposed for the Q220: Functional Status Change for Patients with Lumbar Impairments measure by allowing coding for chiropractic clinicians but emphasized that unless chiropractors are reimbursed for CPT code 98943 which covers extraspinal, one or more regions (currently NOT covered by Medicare), the current three codes will not apply to this measure. Steward: High Priority Measure: Measure Type: Response: This measure can only be submitted utilizing the MIPS CQMs Specifications, which allows all payer data to be submitted not just Medicare. Therefore, chiropractors utilizing CPT code 98943 can include those patients in the denominator for this measure. Specific Medicare reimbursement for this code would not preclude the eligible clinician from submitting this measure. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00426 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.243</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are finalizing the changes to measure Q220 as proposed for the 2019 Performance Period and future years. Please note that the following technical changes were also made to this measure for further accuracy based on feedback from the measure steward: The Measure Title was changed from "Functional Status Change for Patients with Lumbar Impairments" to "Functional Status Change for Patients with Low Back Impairments". The Measure Description was updated to "A patient-reported outcome measure of risk-adjusted change in functional status for patients 14 years+ with low back impairments. The change in functional status (FS) is assessed using the Low Back FS patient-reported outcome measure (PROM) (©Focus on Therapeutic Outcomes, Inc.). The measure is adjusted to patient characteristics known to be associated with FS outcomes (risk adjusted) and used as a performance measure at the patient level, at the individual clinician, and at the clinic level by to assess quality. The measure is available as a computer adaptive test, for reduced patient burden, or a short form (static survey)." The Measure Type was changed from "Outcome" to "Patient Reported Outcome." These changes were also applied to specialty measure sets in Table Group B where this measure is included. (Please note that these technical changes were erroneously characterized as substantive changes in the proposed rule.) Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60261 D20 F unctwna IStatus Ch an2e fior p at1ents with Shou ld er I mpa1rments 0 Cateeory NQF#: Quality#: CMSeCQMID: National Quality Strategy Domain: Current Collection Type: Current Measure Description: Substantive Change: 0 Description 0426 221 N/A Communication and Care Coordination MIPS CQMs Specifications A self-report outcome measure of change in functional status (FS) for patients 14 years+ with shoulder impairments. The change in functional status (FS) assessed using FOTO's (shoulder) PROM (patient reported outcomes measure) is adjusted to patient characteristics known to be associated with FS outcomes (risk adjusted) and used as a performance measure at the patient level, at the individual clinician, and at the clinic level to assess quality The new description is revised to read: A patient-reported outcome measure of risk-adjusted change in functional status for patients 14 years+ with shoulder impairments. The change in functional status (FS) is assessed using the Shoulder FS patientreported outcome measure (PROM) (©Focus on Therapeutic Outcomes, Inc.).The measure is adjusted to patient characteristics known to be associated with FS outcomes (risk adjusted) and used as a performance measure at the patient level, at the individual clinician, and at the clinic level to assess quality. The measure is available as a computer adaptive test, for reduced patient burden, or a short form (static survey). Updated the denominator to allow coding for chiropractors and outpatient eligible clinicians. The new denominator is revised to expand to: Physician Denominator Criteria and Chiropractic Care Denominator Criteria. Focus on Therapeutic Outcomes, Inc. Yes Patient Reported Outcome We expanded the denominator to allow coding for chiropractors and outpatient eligible clinicians. The current measure only includes coding to support physical and occupational therapists. The measure steward has recommended expanding the denominator to include other types of eligible clinicians providing outpatient and chiropractic services. Physical functional Rationale: status is relevant to a broad spectrum of specialties in order to assess the effectiveness of a treatment plan. We agreed with the recommendation and are proposing the expansion as it allows a broader spectrum of eligible clinicians the opportunity to submit outcome measures. Comment: Two commenters supported the substantive change proposed for measure Q221: Functional Status Change for Patients with Shoulder Impairments measure by allowing coding for chiropractic clinicians but emphasized that unless chiropractors are reimbursed for CPT code 98943 which covers extraspinal, one or more regions (currently NOT covered by Medicare), the current three codes will not apply to this measure. Steward: High Priority Measure: Measure Type: Response: This measure can only be submitted utilizing the MIPS CQMs Specifications, which allows all payer data to be submitted not just Medicare. Therefore, chiropractors utilizing CPT code 98943 can include those patients in the denominator for this measure. Specific Medicare reimbursement for this code would not preclude the eligible clinician from submitting this measure. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00427 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.244</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are finalizing the changes to measure Q221 as proposed for the 2019 Performance Period and future years. Please note that the following technical changes were also made to this measure for further accuracy based on feedback from the measure steward: The Measure Description was updated to "A patient-reported outcome measure of risk-adjusted change in functional status for patients 14 years+ with shoulder impairments. The change in functional status (FS) is assessed using the Shoulder FS patient-reported outcome measure (PROM) (©Focus on Therapeutic Outcomes, Inc.).The measure is adjusted to patient characteristics known to be associated with FS outcomes (risk adjusted) and used as a performance measure at the patient level, at the individual clinician, and at the clinic level to assess quality. The measure is available as a computer adaptive test, for reduced patient burden, or a short form (static survey)." The Measure Type was updated from "Outcome" to "Patient Reported Outcome". These changes were also applied to specialty measure sets in Table Group B where this measure is included. (Please note that these technical changes were erroneously characterized as substantive changes in the proposed rule.) 60262 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations . . hElb ow, w· D21 F unctiOn a IS tatus Ch an2e fior p atients nst or H an dl mpa1rments wit Cateeory NQF#: Quality#: CMSeCQMID: National Quality Strategy Domain: Current Collection Type: Current Measure Description: Description 0427 222 N/A Communication and Care Coordination MIPS CQMs Specifications A self-report outcome measure of functional status (FS) for patients 14 years+ with elbow, wrist or hand impairments. The change in FS assessed using FOTO (elbow, wrist and hand) PROM (patient reported outcomes measure) is adjusted to patient characteristics known to be associated with FS outcomes (risk adjusted) and used as a performance measure at the patient level, at the individual clinician, and at the clinic level to assess quality Updated the denominator to allow coding for chiropractors and outpatient eligible clinicians. Substantive Change: The new denominator is revised to expand to: Physician Denominator Criteria and Chiropractic Care Denominator Criteria. Focus on Therapeutic Outcomes, Inc. Yes Patient Reported Outcome We expanded the denominator to allow coding for chiropractors and outpatient eligible clinicians. The current measure only includes coding to support physical and occupational therapists. The measure steward has recommended expanding the denominator to include other types of eligible clinicians providing outpatient and chiropractic services. Physical functional Rationale: status is relevant to a broad spectrum of specialties in order to assess the effectiveness of a treatment plan. We agreed with the recommendation and are proposing the expansion as it allows a broader spectrum of eligible clinicians the opportunity to submit outcome measures. Comment: Two commenters supported the substantive change proposed for measure Q222: Functional Status Change for Patients with Elbow, Wrist or Hand Impairments measure by allowing coding for chiropractic clinicians but emphasized that unless chiropractors are reimbursed for CPT code 98943 which covers extraspinal, one or more regions (currently NOT covered by Medicare), the current three codes will not apply to this measure. Steward: High Priority Measure: Measure Type: Response: This measure can only be submitted utilizing the MIPS CQMs Specifications, which allows all payer data to be submitted not just Medicare. Therefore, chiropractors utilizing CPT code 98943 can include those patients in the denominator for this measure. Specific Medicare reimbursement for this code would not preclude the eligible clinician from submitting this measure. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00428 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.245</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are finalizing the changes to measure Q222 as proposed for the 2019 Performance Period and future years. Please note that the following technical changes were also made to this measure for further accuracy based on feedback from the measure steward: The Measure Description was updated to "A patient-reported outcome measure of risk-adjusted change in functional status (FS) for patients 14 years+ with elbow, wrist or hand impairments. The change in FS is assessed using the Elbow/Wrist/Hand FS patient-reported outcome measure (PROM) (©Focus on Therapeutic Outcomes, Inc.) The measure is adjusted to patient characteristics known to be associated with FS outcomes (risk adjusted) and used as a performance measure at the patient level, at the individual clinician, and at the clinic level to assess quality. The measure is available as a computer adaptive test, for reduced patient burden, or a short form (static survey)." The Measure Type was updated from "Outcome" to "Patient Reported Outcome". These changes were also applied to specialty measure sets in Table Group B where this measure is included. (Please note that these technical changes were erroneously characterized as substantive changes in the proposed rule.) Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60263 . . hG en era10rth ope d"tc I mpatrments D22 F unctiOn a IStatus Ch an2e tior p attents wtt Cate2ory NQF#: Quality#: CMSeCQMID: National Quality Strategy Domain: Current Collection Type: Current Measure Description: Description 0428 223 N/A Communication and Care Coordination MIPS CQMs Specifications A self-report outcome measure of functional status (FS) for patients 14 years+ with general orthopedic impairments (neck, cranium, mandible, thoracic spine, ribs or other general orthopedic impairment). The change in FS assessed using FOTO (general orthopedic) PROM (patient reported outcomes measure) is adjusted to patient characteristics known to be associated with FS outcomes (risk adjusted) and used as a performance measure at the patient level, at the individual clinician, and at the clinic level by to assess quality Updated the denominator to allow coding for chiropractors and outpatient eligible clinicians. Substantive Change: The new denominator is revised to expand to: Physician Denominator Criteria and Chiropractic Care Denominator Criteria. Focus on Therapeutic Outcomes, Inc. Yes Patient Reported Outcome We expanded the denominator to allow coding for chiropractors and outpatient eligible clinicians. The current measure only includes coding to support physical and occupational therapists. The measure steward has recommended expanding the denominator to include other types of eligible clinicians providing outpatient and chiropractic services. Physical functional Rationale: status is relevant to a broad spectrum of specialties in order to assess the effectiveness of a treatment plan. We agreed with the recommendation and are proposing the expansion as it allows a broader spectrum of eligible clinicians the opportunity to submit outcome measures. Comment: Two commenters supported the substantive change proposed for measure Q223: Functional Status Change for Patients with Other General Orthopedic Impairments measure by allowing coding for chiropractic clinicians but emphasized that unless chiropractors are reimbursed for CPT code 98943 which covers extraspinal, one or more regions (currently NOT covered by Medicare), the current three codes will not apply to this measure. Steward: Hil!h Priority Measure: Measure Type: Response: This measure can only be submitted utilizing the MIPS CQMs Specifications, which allows all payer data to be submitted not just Medicare. Therefore, chiropractors utilizing CPT code 98943 can include those patients in the denominator for this measure. Specific Medicare reimbursement for this code would not preclude the eligible clinician from submitting this measure. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00429 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.246</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are finalizing the changes to measure Q223 as proposed for the 2019 Performance Period and future years. Please note that the following technical changes were also made to this measure for further accuracy based on feedback from the measure steward: The Measure Description was updated to "A patient-reported outcome measure of risk-adjusted change in functional status (FS) for patients aged 14 years+ with general orthopedic impairments (neck, cranium, mandible, thoracic spine, ribs or other general orthopedic impairment). The change in FS is assessed using the General Orthopedic FS PROM (patient reported outcome measure) (©Focus on Therapeutic Outcomes, Inc.). The measure is adjusted to patient characteristics known to be associated with FS outcomes (risk adjusted) and used as a performance measure at the patient level, at the individual clinician, and at the clinic level to assess quality. The measure is available as a computer adaptive test, for reduced patient burden, or a short form (static survey)." The Measure Type was updated from "Outcome" to "Patient Reported Outcome". These changes were also applied to specialty measure sets in Table Group B where this measure is included. (Please note that these technical changes were erroneously characterized as substantive changes in the proposed rule.) 60264 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations nmary H ea d ac h e D23 0 veruse ofi magmg orth e E va uat10n ofP. Cateeory NQF#: Quality#: CMSeCQMID: National Quality Strategy Domain: Current Collection Type: Current Measure Description: Description N/A 419 N/A Efficiency and Cost Reduction Medicare Part B Claims Measure Specifications, MIPS CQMs Specifications Percentage of patients with a diagnosis of primary headache disorder whom advanced brain imaging was not ordered Updated the measure analytics to be an inverse measure and remove the assessment of the appropriate use for Computed Tomography Angiography (CTA) and Magnetic Resonance Angiography (MRA). Substantive Change: The new description is revised to read: Percentage of patients for whom imaging of the head (CT or MRI) is obtained for the evaluation of primary headache when clinical indications are not present The new numerator is revised to: Patients for whom imaging of the head (Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)) is obtained for the evaluation of primary headache when clinical indications are not present. American Academy of Neurology Steward: Yes High Priority Measure: Measure Type: Process We adjusted the measure analytics to produce inverse performance data and update the numerator to reflect new clinical evidence regarding the diagnostic imaging modalities (removing CTA and MRA). Updating inverse measure analytics for this measure will appropriately represent the data produced by an overuse measure. The measure development workgroup, procured by AAN, reviewed available evidence and found that there are different indications Rationale: for imaging with CTA and MRA compared to CT and MRI. The indications for clinical management of primary headache, (which are listed in the measure) are only appropriate for CT and MRI. The updated clinical guidelines included in the measure support this as well. Comment: One commenter supported changes to measure Q419: Overuse Ofimaging For Patients With Primary Headache so that it would focus only on CT and MRI scans ordered (omitting CTA and MRA imaging to create consistency with the indication for clinical management of primary headache), and will also capture inverse performance data. However, the commenter underscored that unmet needs continue to exist related to quality measures for migraine and primary headache disorder, and that CMS is missing an opportunity to consider the costly impact of medication overuse that can result from inadequate response to existing treatments for migraine and primary headache disorder. The commenter requested that CMS, along with the MAP, NQF, and other stakeholders consider new and/existing measures that addresses the rate of acute medication overuse among patients suffering from migraine. The Institute for Clinical Systems Improvement (ICSI) has developed the measure, "Percentage of patients with migraine headache with a prescription for opiates or barbiturates for the treatment of migraine" to address overuse of opioids and narcotics for the treatment of migraine headache. Response: We encourage the commenter to collaborate with measure developers to submit measures to the Call for Measures process that have been fully tested and address migraine and headache disorder. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00430 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.247</GPH> amozie on DSK3GDR082PROD with RULES3 FINAL ACTION: We are finalizing the changes to measure Q419 as proposed for the 2019 Performance Period and future years. Please note that the following technical changes were also made to this measure for further accuracy based on feedback from the measure steward: Measure Title was updated from "Overuse ofimaging For Patients With Primary Headache" to "Overuse ofimaging for the Evaluation of Primary Headache". Measure Type was updated from "Efficiency" to "Process". These changes were also applied to specialty measure sets in Table Group B where this measure is included. Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60265 MISCELLANEOUS PUBLIC COMMENTS AND RESPONSES Note: The following table summarizes public comments received that are general to individual MIPS measures but not specific to newly proposed measures, specialty measure sets, measures proposed for removal, or measures with substantive changes. Q005: Heart Failure: Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB) Therapy for Left Ventricular Systolic Dysfunction Specialty Sets: Cardiology, Family Medicine, Internal Medicine Comment: One commenter supported measure QOOS: Heart Failure: Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB) Therapy for Left Ventricular Systolic Dysfunction because there is good evidence that ACE inhibitors and ARBs improve the health of people with heart failure and LVEF < 40%, and the measure aligns with current guidelines and represents high-value care for patients with chronic heart failure. Response: We thank the commenter for the support of measure QOOS: Heart Failure: Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB) Therapy for Left Ventricular Systolic Dysfunction. Q006: Coronary Artery Disease: Antiplatelet Therapy Specialty Sets: Cardiology, Family Medicine, Internal Medicine, Skilled Nursing Facility Comment: One commenter supported measure Q006: Coronary Artery Disease: Antiplatelet Therapy. The evidence base would benefit from re-evaluation as data surfaces on the benefits and risks of aspirin therapy in patients who are already prescribed warfarin therapy as supported by several societies. It may also be difficult for clinicians to capture over the counter aspirin use unless explicitly stated by the patient. Response: We do not see the over the counter aspirin use to be a major impact to performance. In addition, medication lists should include all known prescriptions, over-the counters, herbals, and vitamin/mineral/dietary (nutritional) supplements with the medications' name, dosages, frequency and route of administration. Q007: Coronary Artery Disease: Beta-Blocker Therapy--Prior Myocardial Infarction or Left Ventricular Systolic Dysfunction (LVEF < 40%) Specialty Sets: Cardiology, Family Medicine, Internal Medicine, Skilled Nursing Facility Comment: One commenter supported measure Q007: Coronary Artery Disease: Beta-Blocker Therapy--Prior Myocardial Infarction or Left Ventricular Systolic Dysfunction (L VEF < 40%). However, the commenter cited that skepticism exists surrounding consistency across operating systems to include all billing codes for appropriate exclusion criteria. Furthermore, while the measure is based on clinical recommendations of a number of societies, there is some question surrounding the need for continued beta-blocker therapy for 3 years in low-risk patients in the contemporary era of revascularization. Lastly, it is unnecessarily burdensome for clinicians to look at all L VEF assessments in a complete patient history, and developers should consider revising the specifications to limit the look-back window and exclude patients with a normal LVEF without history ofLVSD. Response: The measure is based on the ACCF/AHNACP/AATS/PCNNSCAI/STS guidelines and we will continue to monitor and collaborate with the measure steward if updated guidelines are published. We disagree that inconsistent billing coding would not allow appropriate exclusion submission. As an eCQM, it has been fully tested to appropriately identizy exclusions within an EHR. As a MIPS CQMs, data is not limited to billing coding to determine exclusions. Documentation of prior LVEF <40% is required to determine denominator eligibility is supported by clinical guidelines. Beta-blockers have been shown to reduce risk of death are recommended indefinitely for patients with CAD and LV systolic dysfunction. Q008: Heart Failure: Beta-blocker therapy for Left Ventricular Systolic Dysfunction Specialty Sets: Cardiology, Family Medicine, Internal Medicine, Skilled Nursing Facility Comment: One commenter supported measure Q008: Heart Failure: Beta-blocker therapy for Left Ventricular Systolic Dysfunction because the balance of evidence shows that long-term treatment with beta-blockers can lessen the symptoms of heart failure, improve the clinical status of patients, and enhance the patient's overall sense of well- being. The measure aligns with current guidelines and represents high-value care for patients with chronic heart failure. Response: We thank the commenter for the support of measure Q008: Heart Failure: Beta-blocker therapy for Left Ventricular Systolic Dysfunction. Q009: Antidepressant Medication Management Specialty Sets: Family Medicine, Internal Medicine, Mental/Behavioral Health Comment: One commenter did not support measure Q009: Antidepressant Medication Management. Reasons cited included: the time frame used in the measure contradicts recommendations from evidence-based guidelines; measure specifications do not consider alternative interventions for depression management such as psychotherapy, electroconvulsive therapy (ECT), or the combination of somatic and psychotherapy; the measure excludes patient choice to switch to another modality of effective therapy due to side effects (where measure specifications should include exclusion criteria for lack of patient adherence due to the side effects of medication with documentation of alternative therapy); the requirement for acute phase treatment should be deleted; and the measure intends to evaluate quality outcomes at the health plan level, but the measure as included in MIPS intends to assess performance at the individual clinician level where clinicians are unaware of information (for example, medication refill data) related to effective management of medication adherence. Specialty Sets: Family Medicine, Internal Medicine, Preventive Medicine, Rheumatology, Geriatrics VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00431 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.248</GPH> amozie on DSK3GDR082PROD with RULES3 Response: We consulted with the measure steward and they will take your suggestions regarding adjustment oftimeframes, alternative interventions, inclusion of patient choice, and assessing outcome evaluation levels under consideration for future updates to this measure. Q039: Screening for Osteoporosis for Women 65-85 Years of Age 60266 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations MISCELLANEOUS PUBLIC COMMENTS AND RESPONSES Note: The following table summarizes public comments received that are general to individual MIPS measures but not specific to newly proposed measures, specialty measure sets, measures proposed for removal, or measures with substantive changes. Comment: One commenter supported measure Q039: Screening for Osteoporosis for Women 65-85 Years of Age. The commenter noted that implementation could promote overuse of screening if patients receive care from multiple clinicians and/or have poor record continuity, and in women who are at lower risk for osteoporosis based on reasonably identifiable factors (for example, BMI, ethnicity). The commenter suggested that developers should consider updating the denominator specifications to include exclusion criteria for patients who have already been assessed with the FRAX tool and for patients receiving hospice and palliative care where the intervention Response: We do not agree that it would promote overuse of screening as it requires documentation of one historical screening. Eligible clinicians are expected to coordinate their care with eligible clinicians. We will provide feedback to the measure steward to include the FRAX tool exclusion to be fully vetted through the annual revision process. In response to the commenter's request to include a hospice exclusion, this is included within the measure specification. Q046: Medication Reconciliation Post-Discharge Specialty Sets: Orthopedic Surgery, Nephrology, General Surgery, Geriatrics Comment: One commenter did not support measure Q046: Medication Reconciliation Post-Discharge although it can help to eliminate medication errors that may occur during transitions of care and will not promote over- or underuse and timely reconciliation of discharge medication lists. The commenter expressed the following concerns: 2013 PQRS participation results do not necessarily represent performance on a national level; the measure has insufficient evidence to support this as an accountability measure and it is a "check the box measure;" a more standardized approach is needed for medication adherence, the numerator specifications exclude clinicians who are capable of reconciling medication lists which could limit the success of this measure from a health plan/integrated delivery system perspective; and clinicians may encounter interoperability barriers to data access. Response: This measure promotes appropriate medication management, communication and care coordination between caregivers. Although the impact of medication reconciliation alone on patient outcomes is not well studied, there is expert agreement that potential benefits outweigh the harm. We applaud the clinicians that adhere to this practice, but believe this concept improves communication and patient safety. This is considered a process measure and we are looking to move towards outcome-based measures. In addition, we encourage the commenter to work with measures' developers to submit new measures through the Call for Measures process. We disagree with the commenter citing barriers based on clinicians utilizing different EHRs. The measure stewards allow multiple methods of medication reconciliation as defined in the numerator. The measure steward has standardized the clinicians that are able to complete the quality action. A prescribing practitioner, clinical pharmacists or registered nurse should conduct medication reconciliation. We will provide your recommendation to the measure steward to include pharmacy technicians in future iterations of the measure specification. Q047: Advance Care Plan Specialty Sets: Cardiology, Gastroenterology, Family Medicine, Internal Medicine, Obstetrics/Gynecology, Orthopedic Surgery, Otolaryngology, Physical Medicine, Preventive Medicine, Neurology, Nephrology, General Surgery, Vascular Surgery, Thoracic Surgery Urology, Oncology, Rheumatology, Geriatrics, Skilled Nursing Facility Comment: One commenter did not support measure Q047: Advance Care Plan, and cited it could prevent overuse of unnecessary end oflife care interventions. The commenter noted the measure is burdensome for clinicians to annually document an advance care plan for all patients aged 65 years and older and also objects to the 12-month measurement period included in the denominator specifications. There is no evidence to guide optimal frequency and at what age to begin planning, and it may be inappropriate for clinicians to perform this intervention during an initial office visit. Lastly, the denominator population could be revised to established patient visits only. Response: We disagree with concern this measure may be burdensome to document an advance care plan annually. The eligible clinician is not required to create a new advance care plan but confirms annually that the plan in the medical record is still appropriate or starts a new discussion. We will provide your suggestion to the measure steward regarding the narrowing of the patient population to established patient only. The measure steward does state the measure is appropriate for use in all healthcare settings (for example, inpatient, nursing home, and ambulatory) except the emergency department. For each of these settings, there should be documentation in the medical record(s) that advance care planning was at least discussed or documented. Eligible clinicians are still able to be numerator compliant if the advance care plan was discussed but the patient did not wish or was not able to name a surrogate decision maker or provide an advance care plan. We maintain the notion that Q047 is a good measure that promotes initiation of communication. With the inclusion of new patient visit coding, this would likely affect all eligible clinicians submitting the measure, therefore data would be comparable. Q050: Urinary Incontinence: Plan of care for Urinary Incontinence in Women Aged 65 Years and Older Specialty Sets: Family Medicine, Internal Medicine, Obstetrics/Gynecology, Urology, Geriatrics Response: There is some high quality evidence for use pelvic floor muscle training in the treatment of older women with UI and pharmacologic treatment if training is unsuccessful. In response to the request to add a denominator exception for patient refusal of a care plan, the measure steward does not allow patient refusals for this measure. We understand the commenter's concern; however, all eligible clinicians submitting measure Q050, regardless of data method, will not have the ability to submit a patient refusal and therefore are comparable when calculating the performance of the measure. QI07: Adult Major Depressive Disorder: Suicide Risk Assessment VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00432 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.249</GPH> amozie on DSK3GDR082PROD with RULES3 Comment: One commenter supported measure Q050: Urinary Incontinence: Plan of care for Urinary Incontinence in Women Aged 65 Years and Older because a performance gap exists, treatments exist to create meaningful improvements in clinical outcomes/quality of life and the benefits of reducing the patient disease burden outweigh the clinician measurement burden. Although, they stated that developers cite weak evidence to support the benefit of care plan development on clinical outcomes in women with urinary incontinence. Additionally, developers should consider updating denominator specifications to include exclusion criteria for patients who refuse care plan services. Lastly, this measure is meant for the system level and individual clinicians may encounter interoperability barriers retrieving this data. Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60267 MISCELLANEOUS PUBLIC COMMENTS AND RESPONSES Note: The following table summarizes public comments received that are general to individual MIPS measures but not specific to newly proposed measures, specialty measure sets, measures proposed for removal, or measures with substantive changes. Specialty Sets: Family Medicine, Emergency Medicine, Mental/Behavioral Health Comment: One commenter supported measure Q107: Adult Major Depressive Disorder: Suicide Risk Assessment but noted several recommendations that could improve the measure quality. These included: the measure is close to being topped out and developers should include current, national performance data in the updated measure report; the numerator is not clearly specified, such as what constitutes a "recurrent" episode because as currently stated, the measure could apply to all follow-up visits with the mention of even well-controlled depression; this is a "check the box measure" with little potential to shift quality; and the measure poses significant burden. Response: We will work with the measure developer to provide additional context in future years. We suggest the commenter to review the full measure specification for guidance on defining a recurrent episode. It clarifies an episode of major depressive disorder (MDD) would be considered to be recurrent if a patient has not had an MDD-related encounter in the past 105 days. If there is a gap of 105 or more days between visits for major depressive disorder (MDD) that would imply a recurrent episode. The 105-day look-back period is an operational provision and not a clinical recommendation, or definition of relapse, remission, or recurrence. Q109: Osteoarthritis: Function and Pain Assessment Specialty Sets: Family Medicine, Orthopedic Surgery, Physical Medicine Comment: One commenter did not support measure Q109: Osteoarthritis: Function and Pain Assessment, citing insufficient evidence to support an appropriate assessment time interval and the denominator specifications are unclear. The measure should specizy utilization of a validated, standardized assessment tool that demonstrates improvements in quality outcomes. It is burdensome for clinicians to perform this assessment at every visit where OA is not the primary patient complaint. The commenter stated this measure is not an appropriate accountability measure for general internists. Additionally, clinicians may encounter interoperability barriers to data access and embedding data into the information system. Response: It is important to remember that absence of hard evidence supporting function and pain assessment is not evidence that it is not effective. It allows eligible clinicians to adjust their treatment plans at the patient level. In response to the request to specizy the validated tools, we direct the commenters to review the measure specification as it provides an extensive list of assessment tools. The submission frequency has been updated for the 2019 performance period to once per performance period. This measure is not required and encourage eligible clinicians to select quality measures that are applicable to their specialty. QllO: Preventive Care and Screening: Influenza Immunization Specialty Sets: Family Medicine, Internal Medicine, Obstetrics/Gynecology, Otolaryngology, Pediatrics, Preventive Medicine, Nephrology, Oncology, Infectious Disease, Rheumatology, Geriatrics, Skilled Nursing Facility Comment: One commenter supported measure Q110: Preventive Care and Screening: Influenza Immunization because the measure aligns with current CDC Advisory Committee recommendations. However, the commenter noted that electronic health record (EHR) information blocking could prevent the transmission of immunization information between competing electronic systems. Response: We continue to align with the Centers for Disease Control and Prevention recommendations for routine annual influenza vaccinations for all persons aged greater than or equal to 6 months. We continue to promote interoperability through Certified Electronic Health Record technology and the prevention of Information blocking. We encourage the reporting of immunizations to the appropriate Registries through Promoting Interoperability performance category and Registry reporting measures. Comment: One commenter supported having measure Q110: Preventive Care and Screening: Influenza Immunization available in multiple specialty sets. Response: We thank the commenter for their support of this measure. Qlll: Pneumococcal Vaccination Status for Older Adults Specialty Sets: Family Medicine, Internal Medicine, Obstetrics/Gynecology, Otolaryngology, Nephrology, Oncology, Infectious Disease, Rheumatology, Geriatrics Comment: One commenter did not support measure Q 111: Pneumococcal Vaccination Status for Older Adults. While this measure represents an important clinical concept, implementation could promote treatment overuse if patients seek medical care from multiple clinicians and/or have poor medical record continuity. In addition, the developer should update the numerator specifications to align with current clinical recommendations on pneumococcal vaccination. Response: The Centers for Disease Control and Prevention continues to recommend the pneumococcal vaccine in adults 65 years and older due to the high incidence of pneumococcal-related deaths and costs associated with this condition. We recommend attempts to locate missing records in a reasonable timeframe so that the initial vaccine not be postponed. We will provide the numerator language feedback to the measure steward. There is a numerator note included within the specification to provide submission guidance. We are exploring options to replace this measure in future performance periods that more closely aligns with the guidelines. However, until this measure can be replaced with a measure promoting pneumococcal vaccination, we believe this measure still promotes pneumococcal vaccination and addresses an important population health matter. As stated within the measure specification: The measure allows administration or documentation ofPCVl3 or PPSV23 vaccine (or both) to be numerator compliant. According to ACIP recommendations, patients should receive both vaccines. The order and timing of the vaccinations depends on certain patient characteristics, and are described in more detail in the ACIP recommendations. Response: We thank the commenter for their support of this measure. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00433 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.250</GPH> amozie on DSK3GDR082PROD with RULES3 Comment: One commenter supported having measure Q 111: Pneumococcal Vaccination Status for Older Adults available in multiple specialty sets. 60268 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations MISCELLANEOUS PUBLIC COMMENTS AND RESPONSES Note: The following table summarizes public comments received that are general to individual MIPS measures but not specific to newly proposed measures, specialty measure sets, measures proposed for removal, or measures with substantive changes. Q112: Breast Cancer Screening Specialty Sets: Family Medicine, Obstetrics/Gynecology, Preventive Medicine Comment: One commenter supported measure Qll2: Breast Cancer Screening due to current evidence and that most health systems that have networks in place to address this issue. However, the commenter expressed concern that this measure could promote screening overuse and that a stronger measure may include exclusion criteria for system and patient related issues (for example, availability of mammography screening tools, patient preference, and limited life expectancy). Also, this measure may be less impactful than other cancer screening measures (for example, MIPS 113: Colorectal Cancer Screening). Response: The measure's intent is to promote preventive breast cancer screening, not to address the overuse of screening. If data supports an overuse of breast screening, we encourage the development of an appropriate use of breast cancer screening measure to be submitted to the annual Call for Measures. The measure steward does incorporate denominator exclusion to exclude patients with bilateral mastectomy, receiving hospice services or residing in an Institutional Special Needs Plans (SNP) or long-term care facility. The intent of the exclusion for individuals age 65 and older residing in long-term care facilities, including nursing homes, is to exclude individuals who may have limited life expectancy and increased frailty where the benefit of the process may not exceed the risks. The numerator allows for patient preference and more accessible screening methods by including screening, diagnostic, film, digital or digital breast tomosynthesis mammography to be considered numerator compliant. Ql13: Colorectal Cancer Screening Specialty Sets: Family Medicine, Preventive Medicine Comment: One commenter supported measure Q113: Colorectal Cancer Screening but expressed that the developer should update the measure specifications to align with current clinical recommendations on colorectal cancer screening. Specifically, numerator specifications should include the option for clinicians to document emerging cancer screening tests (for example, stool FIT-DNA, CT colonography). Additionally, measure specifications do not include appropriate exclusion criteria and could promote overuse of screening in patients where the benefits do not outweigh the risk of harms, and this risk adjustment could be addressed by measure developers. A better measure would include exclusion criteria for patients diagnosed with dementia, patients with limited life expectancy, patients with advanced comorbidities, and patient refusal. Response: The specification defmes the screening to include any of following: Fecal occult blood test (FOBT), Flexible sigmoidoscopy, Colonoscopy Computed tomography (CT) colonography, Fecal immunochemical DNA test (FIT-DNA). The measure's intent is to promote preventive colorectal cancer screening, not to address the overuse of screening. We suggest the commenter review measure Q439: Age Appropriate Screening Colonoscopy which addresses the appropriate use with consideration to the benefits and risks. The measure excludes patients with a diagnosis or past history of total colectomy or colorectal cancer, receiving hospice services, and patient aged 65 or older in Institutional Special Needs Plans or residing in long-term care. The intent of the exclusion for individuals age 65 and older residing in long-term care facilities, including nursing homes, is to exclude individuals who may have limited life expectancy and increased frailty where the benefit of the process may not exceed the risks. The measure steward does not include a patient refusal as it is the eligible clinician's responsibility to educate their patients to see the value of preventive colorectal screening. In addition, all eligible clinicians submitting measure Q113, regardless of data submission method, will not have the ability to submit a patient refusal and therefore are comparable when calculating the performance of the measure. Q116: Avoidance of Antibiotic Treatment in Adults with Acute Bronchitis Specialty Sets: Family Medicine, Internal Medicine, Preventive Medicine, Urgent Care Comment: One commenter supported measure Q116: Avoidance of Antibiotic Treatment in Adults with Acute Bronchitis because implementation could lead to measurable and meaningful improvements in clinical outcomes and prevent overuse of inappropriate antibiotic therapy in patients diagnosed with acute bronchitis. However, the commenter noted the potential for clinicians to manipulate the measure through inaccurate coding of disease classification (that is, ICDIO). Response: Eligible clinicians should not change their billing or documentation to manipulate eligibility or determination of appropriate treatment. Any claims submitted to the CMS are subject to an audit, inclusive of any performance data submitted to the quality program. Ql26: Diabetes Mellitus: Diabetic Foot and Ankle Care, Peripheral Neuropathy -Neurological Evaluation Specialty Sets: Family Medicine, Internal Medicine, Preventive Medicine, Podiatry Response: We disagree with the commenter's performance data as it was based on 2012 PQRS performance data. The 2018 MIPS Benchmark Results reflect an average 58.7 percent compliance rate. This measure is consistent with the recommendation from the Diabetics Foot Disorders: A Clinical Practice Guideline. The measure does not require the test to be repeated once the patient produces a negative result. Neurological examination is required at least once within the 12 months prior to eligible encounter. This aligns with the guidelines for a normal risk profile. We encourage eligible clinicians to perform neurological examination more frequently based on the risk. In response to the lack of evidence to support primary care to evaluate footwear, this is not a required measure VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00434 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.251</GPH> amozie on DSK3GDR082PROD with RULES3 Comment: One commenter did not support measure Ql26: Diabetes Mellitus: Diabetic Foot and Ankle Care, Peripheral Neuropathy -Neurological Evaluation. Issues cited included: the measure developer cites a 44 percent performance gap based on data from the 2012 PQRS reporting year which may inaccurately represent nationwide performance levels; there is insufficient evidence to support a dedicated monofilament examination or the need to repeat the exam once the patient produces negative examination results. The numerator should specify the utilization of neurological assessment tools that are equally as effective as the mono filament in diagnosing neurological deficits in diabetic patients; and there is a lack of high-quality evidence to suggest that regular, comprehensive full lower extremity neurological examinations in the primary care setting improves outcomes for asymptomatic patients. While this measure represents good clinical care, quality improvement programs should not implement this measure to assess the performance quality of individual clinicians. The commenter cited that measure specifications had appropriate exclusion criteria. Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60269 MISCELLANEOUS PUBLIC COMMENTS AND RESPONSES Note: The following table summarizes public comments received that are general to individual MIPS measures but not specific to newly proposed measures, specialty measure sets, measures proposed for removal, or measures with substantive changes. and encourage eligible clinicians to select measures that are clinically appropriate and align with their clinical workflow. Q127: Diabetic Foot & Ankle Care, Ulcer Prevention- Evaluation of Footwear Specialty Sets: Podiatry Comment: One commenter did not support measure Q127: Diabetic Foot & Ankle Care, Ulcer Prevention- Evaluation of Footwear, citing a lack of highquality evidence on improved patient outcomes. This measure is topped with a 93 percent compliance rate although the measure may appropriately evaluate quality performance of podiatrists. Response: We disagree with the commenter's performance data. The 2018 MIPS Benchmark Results reflect an average 55 percent performance rate. The measure is applicable to all eligible clinicians, not just podiatry that was the basis of the commenter' s performance data. In response to the lack of evidence to support primary care to evaluate footwear, this is not a required measure and encourage eligible clinicians to select measures that are clinically appropriate and align with their clinical workflow. QI30: Documentation of Current Medications in the Medical Record Specialty Sets: Cardiology, Gastroenterology, Dermatology, Family Medicine, Internal Medicine, Obstetrics/ Gynecology, Ophthalmology, Orthopedic Surgery, Otolaryngology, Physical Medicine, Preventive Medicine, Neurology, Mental/Behavioral Health, Nephrology, General Surgery, Vascular Surgery, Thoracic Surgery, Urology, Oncology, Infectious Disease, Neurosurgical, Rheumatology, Physical Therapy/Occupational Therapy, Geriatrics, Urgent Care Comment: One commenter did not support measure Q130: Documentation of Current Medications in the Medical Record due to lack of high-quality evidence, it is burdensome for clinicians to document complete medication lists at every patient visit, and it is a "check the box" measure. A more appropriate measure may encourage documentation of medication lists according to clinical necessity and incentivize a standardized, methodological approach to reconciliation, according to clinician practice level (for example, physician, nurse, medical assistant) that leads to improvements in the medication management process. Furthermore, practice variables can impede the physician's ability to document complete accurate medication lists. Response: This measure promotes patient safety to avoid adverse drug events (ADE). Documentation of current medications in the medical record facilitates the process of medication review and reconciliation by the eligible clinicians, which are necessary for reducing ADEs and promoting medication safety. This is considered a process measure and we are looking to move towards outcome-based measures. In addition, the commenter suggested substantive revisions that would require a new measure to be developed. We will continue to explore opportunities to revise this measure, but we encourage the commenter to work with measures' developers to submit new measures through the Call for Measures process. The quality action requires eligible clinicians to attest to documenting, updating or reviewing a patient's current medications using all immediate resources available on the date of encounter. We would expect if eligible clinicians identify uunecessary medications, they would collaborate with their patient to make appropriate adjustments of their medications. While we move towards outcome-based measure, we maintain Q130 initiates a clinical process that would impact patient safety. QI31: Pain Assessment and Follow-Up Specialty Sets: Orthopedic Surgery, Physical Medicine, Urology, Rheumatology, Physical Therapy/Occupational Therapy, Geriatrics, Urgent Care Comment: One commenter did not support measure Q131: Pain Assessment and Follow-Up due to specification flaws that included: (1) performance rates are close to 100 percent; (2) the measure distracts from measurement of change in functional status; (3) implementation of this measure could unintentionally promote overuse of opioid therapy; (4) outdated evidence is cited to form the basis of the measure; (5) specifications do not address the importance of including a functional assessment during the patient visit; 96) specifications do not exclude patients who have known diversions to opioid therapy (for example, substance abuse and alcohol abuse disorders) and this could fuel the opioid epidemic; (7) it is burdensome for clinicians to document pain assessment and follow-up plan at every visit regardless of the patient's primary complaint; (8) referral to a pain management specialist is not practical in every area ofthe country; and (9) the measure language around "eliminating" pain is unreasonable. Response: We continue to move towards high priority measures which include outcome-based measures and opioid measures. The quality action does not require an opioid prescription. We disagree with the commenter' s performance data, based on the 20 18 MIPS Benchmark Results this measure has an average 68.2 percent (MIPS CQMs Specifications) and 87.2 percent (Medicare Part B Claims Measure Specifications) performance rate. The measure does not require a pain management specialist nor an opioid prescription. A follow-up plan may consist of planned follow-up appointment or a referral, a notification to other care clinicians as applicable OR indicate the initial treatment plan is still in effect. These plans may include pharmacologic, interventional therapies, behavioral, physical medicine and/or educational interventions. We do not agree this measure to be burdensome as the tools to assess pain may include the Numeric Rating Scale where documentation of a fraction would meet the screening requirement. We agree with the addition of functional assessment but may add burden which was a concern raised by the commenter. In response to the measure language surround "eliminating pain," we refer the commenter to the measure specification as this is not included within the measure language. Q134: Preventive Care and Screening: Screening for Clinical Depression and Follow-Up Plan Comment: One commenter did not support measure Ql34: Preventive Care and Screening: Screening for Clinical Depression and Follow-Up Plan although it aligns with USPSTF recommendations on screening for clinical depression. The commenter suggested the denominator specifications exclude patients who are currently under the care of a mental health specialist for comorbid illness or severe cognitive impairment. Developers should consider revising the denominator specifications to reflect patients seen in the calendar year instead of all patients. Measure specifications do not define an appropriate screening frequency. It is not clear whether this measure applies to all patients in a clinicians' panel or only those seen during the calendar year in a face-to-face visit. Response: In response to the concerns surrounding the denominator, the measure does not include patients within an active diagnosis of depression or has a VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00435 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.252</GPH> amozie on DSK3GDR082PROD with RULES3 Specialty Sets: Family Medicine, Internal Medicine, Orthopedic Surgery, Pediatrics, Preventive Medicine, Neurology, Mental/Behavioral Health 60270 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations MISCELLANEOUS PUBLIC COMMENTS AND RESPONSES Note: The following table summarizes public comments received that are general to individual MIPS measures but not specific to newly proposed measures, specialty measure sets, measures proposed for removal, or measures with substantive changes. diagnosed bipolar disorder within that patient population. In addition, the measure also allows denominator exceptions for situations where the patient's functional capacity or motivation to improve may impact the accuracy of results of standardized depression assessment tools. Patients are denominator eligible when they meet the denominator criteria within the performance period. For all MIPS quality measures at this time, eligibility is not based on the eligible clinicians' panel but requires an eligible encounter within the performance period as defined by the denominator criteria which allows both face-to-face and telehealth visits. Comment: One commenter provided extensive information on how the PREY 12 Depression Screening (Q134) using the Web Interface methodology is being operationalized in its facility. The commenter provided specific related to the PHQ scores in its decision-making. The commenter's practice has decided on 4, but a score of3 is also accepted in the literature and could be a reasonable cutoff for the PHQ-2. As a result, the commenter asked that CMS consider revisiting how this measure is operationalized to allow the use of evidence-based cutoffs for when further documentation is required. The commenter was also concerned that the measure numerator poses a discrepancy by still requiring depression screening and review to occur in a visit setting. The commenter has adopted a care coordination program where the primary health care provider oversees a multi-disciplinary team to address complex health conditions in a non-visit modality. A Registered Nurse care coordinator may perform the depression screening, review, and arrange for follow up during a non-visit interaction performed at regular intervals. If no active concerns are present, the patient may not be seen again before the end of the measurement period for the health care provider to review the screening at an eligible visit. This results in a measure failure, despite the patient receiving quality team-based care individualized to the patient's situation. Another situation where a patient may receive quality team-based care yet result in the patient not meeting numerator conditions is at the Annual Medicare Wellness visit. Depression Screening is a component of the Medicare Annual Wellness Visit, and one of the MIPS Web Interface required metrics in addition to being used for collection methods such as the EHR collection method. However, the PREY -12 Depression Screening specifications state: The depression screening must be reviewed and addressed in the office of the health care provider filing the code, on the date of the encounter. Our Annual Wellness Visits are typically scheduled within a month of the patient's annual visit with the health care provider; therefore, the only way to meet both requirements is to have the patient complete the depression screening questionnaire twice. The commenter noted this is redundant and takes time away from other components of patient care. The commenter requested that CMS either accept the depression screening performed at the Annual Wellness Visit as meeting the PREY-12 requirements, or eliminate depression screening from the Annual Wellness Visit, or preferably simplify the numerator to allow the latest depression screening and review to occur any time during the measurement period and not tie it to a particular visit. Response: In regards to the determination of a positive screen, whether or not a PHQ-9 (or other standardized screening tool) screening score is considered positive would be determined by the eligible professional administering and reviewing the standardized tool results. The measure steward does not define "positive" so it is at the discretion of the eligible clinician based on their knowledge of the patient to determine if the result is considered positive or negative. For the purpose of submitting PREY-12 information, the measure requires medical record documentation of positive or negative for the depression screen result per the measure steward. There are only two instances when specific documentation of positive or negative is not required. One instance is when the PHQ result is 0 in which case the result can be assumed to be negative. The other instance is when there is documentation of a depression screen using a normalized and standardized screening tool and at the same encounter there is documentation of a recommended follow up, in which case it can be assumed the result of the screen was positive. The Web Interface allows for telehealth for PREV-12, so it is not necessary to tie the review of the screening results to a specific encounter. As long as the most recent screening during the measurement period is used, the screening occurred during the measurement period, there is documentation of positive or negative, the results have been reviewed by the clinician, and if positive a recommended follow up, the measure has been met. Based on the commenter's scenario, this workflow would not cause the eligible clinician to fail the quality action. We encourage the commenter to work with the measure subject matter experts through the Quality Payment Program Service Center to address the concerns. Q154, Q155, and Q318 Specialty Sets: Q154: Family Medicine, Internal Medicine, Orthopedic Surgery, Otolaryngology,, Neurology, Podiatry, Physical Medicine, Preventive Medicine Q155: Family Medicine, Internal Medicine, Neurology, Orthopedic Surgery, Otolaryngology, Physical Medicine, Preventive Medicine, Podiatry Q318-0rthopedic Surgery, Nephrology Comment: One commenter did not support measures Q154, 155, and 318 (NQF measure Q0101 ): Falls: Screening, Risk-Assessment, and Plan of care to Prevent Future Falls as it is unclear whether they will lead to meaningful improvements in clinical outcomes. The commenter suggested that developers consider revising the denominator specifications to include only those patients who are at high-risk of falling. Clinicians should individualize the plan of care and the care plan should be less prescriptive to account for individual patient requirements. Data collection burden associated with the multiple measure components is high and data elements seem unlikely to capture how well the service was performed. The measure relies heavily on CPT-II codes which are not widely used or captured in electronic health records (EHRs ). Also, developers should consider updating the specifications to reflect the most current clinical recommendations of the USPSTF. Additionally, the evidence-base for what clearly defines best practice is complex. Lastly, while the numerator is clearly defined, it is complicated with variable validity and the components of the risk assessment model are not clearly defined. Specialty Sets: Orthopedic Surgery, Rheumatology Comment: One commenter did not support measure Q180: Rheumatoid Arthritis: Glucocorticoid Management, citing that they did not receive adequate VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00436 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.253</GPH> amozie on DSK3GDR082PROD with RULES3 Response: Please note these measures were being proposed for removal from the MIPS program in 2019 and we proposed a new combined Falls measure (Q477 based on specifications in NQF 0101) that will include strata components for Future Falls Risk, Falls Risk Assessment, and Falls Risk Plan of Care. As discussed already, the proposed new Q477 Falls: Screening, Risk-Assessment, and Plan of Care to Prevent Future Falls measure will not be finalized for inclusion as the measure steward believes it is not implementable at this time. Therefore, these three measures will remain in the program for the 2019 performance period as it is important to evaluate for high-risk of falling. We appreciate the feedback regarding these measures and encourage the commenter to discuss their suggestions with the measure steward for their consideration in updates for these measures. A comprehensive falls assessment is multifactorial and should be performed by a health care professional with appropriate skills and experience. Q180: Rheumatoid Arthritis: Glucocorticoid Management Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60271 MISCELLANEOUS PUBLIC COMMENTS AND RESPONSES Note: The following table summarizes public comments received that are general to individual MIPS measures but not specific to newly proposed measures, specialty measure sets, measures proposed for removal, or measures with substantive changes. information from the developer to evaluate the validity ofthis measure. The commenter noted the numerator and the denominator are poorly specified. The measure specifications do not include appropriate exclusions for patients prescribed prednisone therapy for a symptomatic flare. A cleaner measure may specifY "patients with rheumatoid arthritis who are on glucocorticoids" in the denominator statement. Additionally, clinical guidelines demonstrate the importance of assessing glucocorticoid use, but only in patients who have specifically been prescribed glucocorticoid therapy. Response: We will work with the measure steward to consider the suggested denominator exception. Limiting the denominator to those patients with RA who are on a glucocorticoid would limit the clinician's ability to report on the measure and may not capture those RA patients who are started on a glucocorticoid during the performance period. Q181: Elder Maltreatment Screen and Follow-Up Specialty Sets: Family Medicine, Internal Medicine, Neurology, Mental/Behavioral Health, Geriatrics, Skilled Nursing Facility Comment: One commenter did not support measure Q181: Elder Maltreatment Screen and Follow-Up, citing that implementation could promote overuse of unnecessary, elder services referrals and potentially fracture relationships between clinicians and their patients. The commenter stated the measure does not align with USPSTF recommendations on abuse of elderly and vulnerable adults. The commenter also stated that developers should consider revising the numerator specifications to clearly define "high risk" as some way other than age (for example, cognitive impairment, functional impairment). Moreover, the numerator details specify an overly prescriptive screening process. It may be clinically inappropriate to screen all patients over the age of 65 for elder abuse. Developers should consider revising the measure to specifically encourage screening in patients who are dependent on a caregiver or who are otherwise at risk for abuse. It is unnecessarily burdensome for physicians to document maltreatment screening for all patients aged 65 years and older at every visit. Finally, the measure requires clinicians to assess for maltreatment using a screening tool even when abuse may be readily apparent. Response: Though the USPSTF does not support elder maltreatment screening, we respectfully disagree. It is important to remember that absence of hard evidence supporting screening is not evidence that it is not effective. There have been many qualitative reports that do support the benefits of screening. Expert consensus and public policy for mandatory reporting support the value of screening this vulnerable population. It is unclear how a definition of high risk would benefit the numerator. Limiting the denominator to patients who are dependent on a caregiver or who are otherwise at risk for abuse would be subjective and may not identify all instances of elder maltreatment. This measure advocates for a vulnerable patient population and do not agree that limiting the measure to a high-risk patient population would be appropriate. The measure does not limit to high risk patients but requires elder maltreatment screening for all patients over the age of 65 years. Q205: HIV/AIDS: Sexually Transmitted Diseases- Screening for Chlamydia, Gonorrhea, and Syphilis Specialty Sets: Pediatrics, Infectious Disease Comment: One commenter did not support measure Q205: IDV/AIDS: Sexually Transmitted Diseases- Screening for Chlamydia, Gonorrhea, and Syphilis even though developers cite a significant performance gap based on data from the 2011 PQRS reporting year and that implementation will likely lead to meaningful improvements in clinical outcomes. The measure does align with the USPSTF and CDC recommendations on the prevention and treatment of opportunistic infections in mv -infected adults, yet the commenter stated the implementation of the measure could promote overuse of screening in asymptomatic patients and in situations where clinicians encounter interoperability barriers to data retrieval. While specifications include an evidence-based time interval, they are flawed in a number of respects. The numerator and denominator envision one test since HIV diagnosis, although new infections and reinfections may occur repeatedly; gonorrhea screening may encompass several loci of infection, which should be listed; and the measure does not include an appropriate exclusion for patients who are not sexually active or otherwise unlikely to become infected. Also, the numerator specifies an indefinite look-back window. Developers should consider revising the specifications to include an evidence-based look-back window. Response: We disagree this measure will lead to screening overuse. The denominator is limited to a high-risk patient population and we promote interoperability and is the responsibility of the care team to provide care coordination. We do agree that the subsequent screening may be appropriate to detect new or recurrent infections. We will provide this suggestion to the measure steward for possible inclusion during the annual revision cycle. In response to the request for appropriate exclusion for patients who are not sexually active or otherwise unlikely to become infected, the measure does allow for patient refusal as a denominator exception. While we agree with the suggestion to add subsequent screening for reinfection, it does not invalidate the measure. It may be more appropriate to include an annual risk assessment. The cost of screening and the variability of prevalence of these infections, decisions about routine screening for these infections should be based on epidemiologic factors (including prevalence of infection in the community or the population being served), availability of tests, and cost Q217: Functional Status Change for Patients with Knee Impairments Q218: Functional Status Change for Patients with Hip Impairments Q219: Functional Status Change for Patients with Foot or Ankle Impairments Q220: Functional Status Change for Patients with Lumbar Impairments Q221: Functional Status Change for Patients with Shoulder Impairments Q222: Functional Status Change for Patients with Elbow, Wrist or Hand Impairments Q223: Functional Status Change for Patients with General Orthopedic Impairments Comment: One commenter stated that the issue with FOTO (Focus on Therapeutic Outcomes) measures is the measure may require payment to use the measure. Eligible clinicians may not have 100 patients in the specific joint being measured to meet the measure requirements. As a result, the clinician needs to get an exemption because he or she may not have 100 patients eligible, such as for the hip measure Q218. Also, the measure for functional outcome (general) becomes mutually exclusive to these individual FOTO measures. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00437 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.254</GPH> amozie on DSK3GDR082PROD with RULES3 Specialty Sets: Physical Therapy/Occupational Therapy 60272 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations MISCELLANEOUS PUBLIC COMMENTS AND RESPONSES Note: The following table summarizes public comments received that are general to individual MIPS measures but not specific to newly proposed measures, specialty measure sets, measures proposed for removal, or measures with substantive changes. Response: As indicated within the measure specification's Copyright, the functional status measures are available in both short form (static/paper-pencil) and computer adaptive test formats, together with a scoring table and risk adjustment specifications, free of charge for the purposes of individual clinical practice, that is, patient-level measurement, including but not limited to for the purposes of participation in MIPS. We acknowledge that meeting this minimum threshold can be challenging for some eligible clinicians but for scoring purposes you would only need 20 eligible patients to meet the minimum reliability threshold for each of the measures which may be more feasible to achieve. The functional outcome (general) measure is ensuring that all visits regardless of impairment has functional outcomes assessed and although these would be covered in the functional status change measures it also measures other impairments. Q226: Preventive Care and Screening: Tobacco use: Screening & Cessation Intervention Specialty Sets: Cardiology, Gastroenterology, Dermatology, Family Medicine, Internal Medicine, Obstetrics/Gynecology, Ophthalmology, Orthopedic Surgery, Otolaryngology, Physical Medicine, Preventive Medicine, Neurology, Mental/Behavioral Health, General Surgery, Vascular Surgery, Thoracic Surgery, Urology, Oncology, Neurosurgical, Podiatry, Rheumatology, Urgent Care Comment: One commenter supported measure Q226: Preventive Care and Screening: Tobacco use: Screening & Cessation Intervention because reduction of tobacco use slows the progression of respiratory disease, tobacco use is a modifiable risk factor, and the measure aligns with clinical recommendations. Response: We thank the commenter for the support of measure Q226: Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention. Q236: Controlling High Blood Pressure Specialty Sets: Obstetrics/Gynecology, Vascular Surgery, Thoracic Surgery, Rheumatology Comment: One commenter did not support measure Q236: Controlling High Blood Pressure although it may result in measurable and meaningful improvements in clinical outcomes and there is a known performance gap in the area of blood pressure control. The commenter stated that the specifications for the measure under consideration for NQF-endorsement align with several societies, the MIPS measure specifications do not stratify patients into well-defined risk groups (that is, comorbid disease diagnosis) and guidelines from its own society. Furthermore, the numerator specifications define office measurements as the preferred monitoring method, while home monitoring is the preferred method to assess for adequately controlled BP. The commenter suggested that developers update the numerator specifications to include an average of several measurement results to increase accuracy and reduce the potential for overtreatment. Finally, the measure was created to assess system-level performance and may not be an appropriate accountability measure for individual clinicians who do not have access to all BP measurement results. The commenter supported CMS adoption of this measure if approved by NQF. Response: We agree with updating the numerator to reflect the updated blood pressure values and have been discussing the revision with the measure steward. We do not agree with taking an average blood pressure as the performance is determined by the most recent blood pressure value. It does allow for multiple blood pressure readings during an eligible visit, using the lowest systolic and the lowest diastolic reading as the most recent blood pressure reading. We agree with the measure steward to exclude home readings due to the variability and may not be an accurate representation of blood pressure measurements. In addition, performance can be determined by blood pressure taken by any clinician within the clinician office. This would include blood pressure readings from other eligible clinicians participating in the patient care (that is consultation notes). We maintain the opinion this is a good measure since the new guidelines have not been widely accepted and will allow time for eligible clinicians to adopt the updated blood pressure values. This measure also encourages management of a prevalent condition. Comment: Several commenters indicated that for measure Q236: Controlling High Blood Pressure that it should be revised to reflect recent national consensus about appropriate blood pressure measurements. A national consensus has developed that blood pressure should vary by age and diagnosis. The MIPS measure requires a strict policy of controlling to less than 140/90 for hypertensive patients, regardless of age, and 120/80 for screening purposes. These levels are not consistent with current medical evidence or opinion such as those noted in the Eighth Joint National Committee. There should be a mechanism for removal of a measure that is no longer consistent with clinical guidelines or current practice and adding the measure back to the program when re-specified. Response: We appreciate the recommendation to update the guidelines and agree the measure should be updated in future revision cycles. However, we maintain the opinion this is a good measure since the new guidelines have not been widely accepted and will allow time for eligible clinicians to adopt the updated blood pressure values. This measure also encourages management of a prevalent condition and is limited to patients with an existing hypertension diagnosis. Additionally, the intent of the measure is not to screen patients for hypertension. Q238: Use of High-Risk Medications in the Elderly Specialty Sets: Cardiology, Family Medicine, Internal Medicine, Rheumatology, Geriatrics Response: We disagree with interoperability barrier, but suggest all eligible clinician maintain a current medication list, especially for patient received high-risk medications. We will provide the commenter's recommendation to risk-stratify and increase the age criteria from 65 to 80 years of age to be vetted through a technical expert panel and possible inclusion in subsequent revision cycles. One study ofthe prevalence of potentially inappropriate medication use in older adults found that 40 percent of individuals 65 and older filled at least one prescription for a potentially inappropriate medication and 13 percent filled two or more (Fick et a!. 2008). While some adverse drug events are not preventable, studies estimate that between 30 and 80 percent of adverse drug events in the elderly are preventable (MacKinnon and Hepler 2003). The measure is based on recommendations from the American Geriatrics Society Beers Criteria for VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00438 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.255</GPH> amozie on DSK3GDR082PROD with RULES3 Comment: One commenter did not support measure Q238: Use of High-Risk Medications in the Elderly, citing that controversial criteria was used to form the basis of the measure, which is based on expert opinion as opposed to high-quality evidence. The commenter noted issues with the measure specifications as follows: the denominator may inaccurately define "elderly adults" as > 65 years of age and developers should consider increasing the denominator threshold to > 80 years of age; the denominator specifications do not stratify patients into well-defined risk groups; the measure specifies medications that are not presumed to be high risk in all elderly adults (for example, acetaminophen); and the specifications do not include exclusion criteria for patient preference. Lastly, individual clinicians may encounter interoperability barriers to patient information access. Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60273 MISCELLANEOUS PUBLIC COMMENTS AND RESPONSES Note: The following table summarizes public comments received that are general to individual MIPS measures but not specific to newly proposed measures, specialty measure sets, measures proposed for removal, or measures with substantive changes. Potentially Inappropriate Medication Use in Older Adults. The criteria were developed through key clinical expert consensus processes by Beers in 1997, Zahn in 2001 and an updated process by Fick in 2003, 2012 and 2015. Q243: Cardiac Rehabilitation: Patient Referral from an Outpatient Setting Specialty Sets: Cardiology, Family Medicine, Internal Medicine Comment: One commenter supported measure Q243: Cardiac Rehabilitation: Patient Referral from an Outpatient Setting. However, the commenter advised developers to address the following concerns during the update process to improve the measure quality: the measure is nearly capped out; implementation of this measure could unfairly penalize clinicians who practice in rural areas and who care for medically complex patient populations, so risk or socioeconomic adjustment is advised; the measure is an inappropriate accountability measure for general internists who do not report data in the PINNACLE registry; the measure may not apply well to clinicians practicing in rural settings where patients have limited access to rehabilitative services; and patients who are faced with significant travel burdens are less likely to adhere to prescribed services. Response: We encourage the commenters to work with measures' developers to submit new measures through the Call for Measures process that would address the appropriate diagnosis and testing of COPD as we currently do not have a benchmark established for this measure. In addition, the performance data supplied was derived from a single qualified registry. We disagree that this measure may unfairly penalize clinicians who practice in rural areas and who care for medically complex patient populations. The numerator includes denominator exceptions for both system and medical reasons for not referring to an outpatient cardiac rehabilitation program. The measure does not hold general internists inappropriately accountable for referrals, as this is not a required measure. Eligible clinicians are able to choose the measures that are clinically appropriate for their specialty. Q268: Epilepsy: Counseling for Women of Childbearing Potential with Epilepsy Specialty Sets: Neurology Comment: One commenter did not support measure Q268: Epilepsy: Counseling for Women of Childbearing Potential with Epilepsy although it addresses a clinical condition that is high- impact and the measure developers cite a significant gap in care. The commenter stated that evidence cited to form the basis of the measure where the interventions could potentially result in harmful patient outcomes. Problems were cited with measure specifications. The denominator specifications should include exclusion criteria for surgically sterile women, women without a history of recent seizure, and women who are not currently prescribed pharmacotherapy; the numerator defmition of counseling seems overly inclusive and not necessary in all cases. Requiring six dimensions for counseling could be overly prescriptive and developers should consider revising the specifications to allow for selection of appropriate therapy that is most relevant to individual patients (that is, change the definition to include "or" rather than "and"); Developers should consider revising the denominator specifications to include women aged 45 years and older who are of childbearing potential. The commenter stated that while the many of the specifications are flawed, the developers do include validity and reliability data in the measure. Response: To address the comment regarding denominator exclusion, we encourage the commenter to review the 2019 measure specification as the measure steward has revised the measure to exclude menopausal or surgically sterile patients. We disagree on the exclusion for patients without a recent seizure, and women who are not currently prescribed pharmacotherapy. Impacts to fertility and pregnancy risks are not limited patients receiving pharmacologic therapy. The measure steward indicates counseling should include discussion about folic acid supplementation, contraception, and potential anti-seizure medications effect on pregnancy, safe pregnancies, and breastfeeding. While we agree this definition covers an inclusive list of counseling areas, it does allow eligible clinicians to exercise their clinical judgment if medical reasons exist for not completing counseling women of childbearing potential with epilepsy. We agree with the expansion of the denominator criteria to include women who are 45 years and older who are of childbearing potential. We have requested the measure steward to consider expanding the age criteria during the annual revision cycle of the quality measures. We still believe the measure addresses an important clinical topic; the narrow denominator does not invalidate the measure. Q271: mD: Preventive Care: Corticosteroid Related Iatrogenic Injury--Bone Loss Assessment Specialty Sets: Gastroenterology Response: The intent of the measure is to screen patients who are at risk of fracture. This knowledge can assist eligible clinicians in creation of their treatment plan. We disagree that the measure would lead to overuse of dexa-scans. Individuals who received an assessment for bone loss during the year prior and current year are considered adequately screened. Corticosteroid use is the variable most strongly associated with osteoporosis (level A evidence). However, it is difficult to distinguish corticosteroid use from disease activity in terms of causal impact on bone density, because the two are closely linked. However, there is strong evidence that those on long-term steroids of greater than 3 months have a significant increase risk of fracture (Papaioannou A et a!. All Patients with Inflammatory Bowel Disease Should Have Bone Density Assessment: Pro. Inflammatory Bowel Diseases. 2001.7(2): 158-162). In response to lowering the threshold from 10 mg/day to 2.5-7 mg/day, this would expand the denominator requiring additional screening. We will provide both of the commenter' s concerns regarding dexa overuse and the request to expand the denominator to the measure steward to identify the appropriate population, but based on the VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00439 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.256</GPH> amozie on DSK3GDR082PROD with RULES3 Comment: One commenter did not support measure Q271: IBD: Preventive Care: Corticosteroid Related Iatrogenic Injury--Bone Loss Assessment, citing that measure developers do not cite high-quality evidence to form the basis of the measure and using dexa-scans to assess for risk of bone loss does not necessarily prevent hip fractures in patients prescribed corticosteroid therapy for IBD. Furthermore, implementation could promote overuse of dexa scans and underuse of corticosteroid therapy. Numerator specifications encourage clinicians to screen patients who receive 10 mg/day of prednisone for 60 days, while evidence demonstrates that hip fractures are significantly higher in patients treated with medium steroid doses (2.5-7mg/day) over a duration of time. As written, the numerator could miss patients who are at risk for fracture. Also, it is unclear whether the measure encourages clinicians to screen patients who are currently prescribed prophylactic bisphosphonate therapy for risk of bone loss, which may not be clinically necessary. Lastly, developers should consider revising the numerator specifications to include an evidence-based look-back window for review of medication history as that is less burdensome. Another commenter also expressed concerns related to the numerator of this measure reflecting the risk of bone loss associated with oral corticosteroids, at any time over the patient's life, exceeding 5 mg/day for 3 or more consecutive months. 60274 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations MISCELLANEOUS PUBLIC COMMENTS AND RESPONSES Note: The following table summarizes public comments received that are general to individual MIPS measures but not specific to newly proposed measures, specialty measure sets, measures proposed for removal, or measures with substantive changes. provided response, we maintain the notion this is an appropriate measure. Q281: Dementia: Cognitive Assessment Specialty Sets: Neurology, Mental/Behavioral Health, Geriatrics Comment: One commenter did not support measure Q281: Dementia: Cognitive Assessment, citing a lack of high-quality evidence on the assessment of cognitive status on clinical outcomes or assessment intervals, and it is unclear how clinicians should manage assessment results. The numerator specifications include cognition assessment tools that will not necessarily benefit clinical outcomes and adherence to a formal assessment protocol is burdensome on clinicians. A more meaningful measure may encourage assessments that are likely to lead to meaningful improvements in clinical outcomes. Furthermore, the numerator specifications include proprietary cognition assessment tools (for example, Mini-Mental State Examination) that are not readily accessible to clinicians who practice in primary care settings. Response: The measure is supported by the Guidelines for the Management of Cognitive and Behavioral Problems in Dementia. Initial and ongoing assessments of cognition are fundamental to the proper management of patients with dementia. These assessments serve as the basis for identifying treatment goals, developing a treatment plan, monitoring the effects of treatment, and modifying treatment as appropriate. While there is not a set interval for assessment, the guidelines state that assessments and visits will be based on the severity or complexity of the patient's status. For this measure, the cognitive assessment should be completed at least once per performance period but does not penalized clinicians for additional cognitive assessments completed throughout the performance period. We thank the commenter for the suggestion create more meaningful improvements to clinical outcomes and encourage the commenter to work with measures' developers to submit new measures through the Call for Measures process. We do not agree with the concern that the numerator has proprietary cognition tools as the measure also includes non-proprietary options for eligible clinician use. Q283: Dementia: Associated Behavioral and Psychiatric Symptoms Screening and Management Specialty Sets: Neurology, Mental/Behavioral Health, Geriatrics Comment: One commenter did not support measure Q283: Dementia: Associated Behavioral and Psychiatric Symptoms Screening and Management, citing a lack of high-quality evidence examining the impact of assessment on clinical outcomes or on appropriate assessment intervals, and implementation may result in overuse of pharmacologic therapy. Non-pharmacologic treatment modalities exist to manage neuropsychiatric symptoms, but implementation requires caregiver involvement. The commenter stated that numerator details do not clearly specify a structured process for documentation of neuropsychiatric symptom assessment and the measure developers do not describe any reliability or validity data in the measure report. Response: The measure is supported by the Guidelines for the Management of Cognitive and Behavioral Problems in Dementia. Neuropsychiatric symptoms may go unrecognized and untreated by eligible clinician do not actively screen their patients with specific attention to discrete symptom domains. We disagree with the unintended consequences identified by the commenter. The measure does not promote the use of pharmacologic interventions. The Clinical Recommendation Statements within the specification state, "new trials and studies better define adverse effects, but they do not strengthen the evidence for efficacy of antipsychotic dmgs in treating psychosis or agitation. Rather, they demonstrate minimal or no efficacy with strong placebo effects, as well as variations in response with trial duration. These findings strengthen the support for using nonpharmacological interventions and environmental measures to attempt to reduce psychosis and agitation prior to initiation of medications." In addition, the specification provides examples of reliable and valid instruments to document neuropsychiatric symptom assessment. Q286: Dementia: Counseling Regarding Safety Concerns Specialty Sets: Neurology, Mental/Behavioral Health, Geriatrics Comment: One commenter did not support measure Q286: Dementia: Counseling Regarding Safety Concerns although it can lead to improved safety outcomes and the measure specifications are appropriate. The commenter stated there is no evidence to support the impact of this intervention on clinical outcomes, the level or intensity of counseling required to change behavior, or the interval at which this intervention should be performed. This measure is also burdensome on clinicians and there is a lack of high quality evidence to support the intervention as an accountability measure. Response: The measure is supported by the American Psychiatric Association practice guideline for the treatment of patients with Alzheimer's disease and other dementias. Screening for safety concerns has been identified as a major unrnet need of persons with dementia. Though the guidelines do not identify the impact of the intervention, it is important to remember that absence of hard evidence supporting screening is not evidence that it is not effective. Q288: Dementia: Caregiver Education and Support for Patients with Dementia Specialty Sets: Neurology, Mental/Behavioral Health, Geriatrics Response: The measure is supported by the Optimal management of Alzheimer's disease patients: Clinical guidelines and family advice. The American Medical Association (AMA) has developed a standard Caregiver Health Self-Assessment Questionnaire to help caregivers analyze their own behavior and health risks and, with the eligible clinician's assistance, make decisions that will benefit both the caregiver and the patient. This questionnaire is available on the AMA website. Based on the results of the assessment, the eligible clinician would be required to provide education and resources based on their clinical expertise. These components have been defined within the measure specification. Though the guidelines do not defme the level of counseling or impact of the VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00440 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.257</GPH> amozie on DSK3GDR082PROD with RULES3 Comment: One commenter did not support measure Q288: Dementia: Caregiver Education and Support for Patients with Dementia because it may be inappropriate for clinicians to advise caregivers on medical concerns without performing appropriate clinical assessments and there is no evidence to support the impact of this intervention on clinical outcomes, the level or intensity of counseling required to change behavior, or the interval at which this intervention should be performed. Developers do not present any validity or reliability data within the measure report. Lastly, this measure is burdensome on clinicians and there is a lack of high- quality evidence to support the intervention as an accountability measure. Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60275 MISCELLANEOUS PUBLIC COMMENTS AND RESPONSES Note: The following table summarizes public comments received that are general to individual MIPS measures but not specific to newly proposed measures, specialty measure sets, measures proposed for removal, or measures with substantive changes. intervention, it is important to remember that absence of hard evidence supporting screening is not evidence that it is not effective. Q305: Initiation and Engagement of Alcohol and Other Drug Dependence Treatment Specialty Sets: Family Medicine, Internal Medicine, Pediatrics Comment: One commenter did not support measure Q305: Initiation and Engagement of Alcohol and Other Drug Dependence Treatment because the specifications are flawed and the measure is not appropriately specified to evaluate performance at the level ofthe individual clinician. Developers should consider dividing the numerator statement to form two discrete measures: (1) initiation of alcohol and other drug dependence treatment; and (2) engagement of alcohol and other drug dependence treatment. Also, it is unclear what constitutes a "new episode of drug or alcohol dependency." The commenter did not support including this measure in accountability programs designed to assess performance of individual clinicians. It is unclear whether individual clinicians will be able to control the outcomes of this measure, and individual clinicians will likely face interoperability challenges to data collection. Response: We will forward the commenter' s recommendation to divide the numerator into two separate measures, but we believe the measure is appropriately specified into one measure. We refer the commenter to the measure specification for the definition of episode: The new episode of alcohol and other drug dependence should be the first episode of the measurement period that is not preceded in the 60 days prior by another episode of alcohol or other drug dependence. This measure is attributed to eligible clinicians who provide care to patients diagnosed with alcohol, opioid, or other drug abuse or dependency. It is important to intensify the monitoring for substance use during periods when the patient is at a high risk of relapsing, including during the early stages of treatment, times of transition to less intensive levels of care, and the first year after active treatment has ceased. Q309: Cervical Cancer Screening Specialty Sets: Family Medicine, Internal Medicine, Obstetrics/Gynecology Comment: One commenter supported measure Q309: Cervical Cancer Screening because the current evidence supports screening in women 21-64 years of age, and this measure is based on the most recent USPSTF recommendations on cervical cancer screening. Response: We thank the commenter for the support of measure Q309: Cervical Cancer Screening. Q310: Chlamydia Screening in Women Specialty Sets: Obstetrics/Gynecology, Pediatrics Comment: One commenter supported measure Q310: Chlamydia Screening in Women because it aligns with USPSTF and CDC recommendations, is supported by evidence and denominator criteria is clearly specified. Response: We will continue to align with USPSTF and CDC recommendations on Chlamydia screening. Q317: Preventive Care and Screening: Screening for High Blood Pressure and Follow-Up Documented Specialty Sets: Cardiology, Gastroenterology, Dermatology, Family Medicine, Internal Medicine, Emergency Medicine, Obstetrics/Gynecology, Orthopedic Surgery, Otolaryngology, Physical Medicine, Preventive Medicine, Neurology, Mental/Behavioral Health, Nephrology, General Surgery, Vascular Surgery, Thoracic Surgery, Urology, Oncology, Rheumatology, Urgent Care, Skilled Nursing Facility Comment: Two commenters provided feedback for measure Q317: Preventive Care and Screening: Screening for High Blood Pressure and Follow-Up Documented, citing that the measure developers should update the measure specifications to align with current Joint National Committee-S (JNC-8), USPSTF, and American College of Physicians (ACP) clinical recommendations on blood pressure screening and management. Additionally, the denominator specifications should include exclusion criteria for patients with medical contraindications to treatment (for example, frail, elderly adults, patients with life limiting diagnoses). Another commenter expressed concerns about the numerator criteria for measure Q317: Preventive Care and Screening: Screening for High Blood Pressure and Follow-Up Documented. Specifically, the commenter stated that most doctors believe it goes against their medical training to recommend evaluation/referral to a primary care physician and/or lifestyle changes to someone who has a blood pressure reading of 122/82. Response: We agree with aligning with the most current blood pressure guidelines. We disagree with the recommendation to exclude elderly, frail, or patients with life limiting diagnosis citing contraindications for treatment. In response to the commenters concerns regarding the numbers, for the 2019 performance period, this blood pressure value falls into the "Pre-Hypertensive BP Reading" classification. The recommendation may consist of a blood pressure rescreen within 1 year and promoting of physical activity, alcohol reduction, weight reduction or changes in diet which have limited contraindications to recommend. We may update the level of blood pressure reading in the future based on new blood pressure guidelines. We maintain the opinion this is a good measure since the new guidelines have not been widely accepted and will allow time for eligible clinicians to adopt the updated blood pressure values. This measure also encourages management of a prevalent condition. Q321: CAHPS Clinician & Group Surveys (CG-CAHPS)-Adult, Child Comment: One commenter did not support measure Q321: CARPS Clinician & Group Surveys (CG-CAHPS)-Adult, Child, citing that implementation could promote overuse of unnecessary treatments where the potential benefits do not outweigh the risk of harms (for example, opiate prescriptions, imaging studies). The commenter stated that developers do not present any evidence to form the basis of the measure and that validity of the survey process and the impact of survey results on improving patient outcomes is in question. Individual clinicians should not be held accountable to organizational factors beyond their control (for example, appointment wait times, and friendliness of stafl). VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00441 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.258</GPH> amozie on DSK3GDR082PROD with RULES3 Specialty Sets: Family Medicine, Internal Medicine 60276 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations MISCELLANEOUS PUBLIC COMMENTS AND RESPONSES Note: The following table summarizes public comments received that are general to individual MIPS measures but not specific to newly proposed measures, specialty measure sets, measures proposed for removal, or measures with substantive changes. Response: We disagree that the CARPS survey promotes the overuse of unnecessary treatments, but rather addresses the quality and appropriate access to healthcare services. While the survey does ask patients the level of friendliness of the staff, improving the patient experience throughout the course of treatment aligns with program goals. Q322: Cardiac Stress Imaging Not Meeting Appropriate Use Criteria: Preoperative Evaluation in Low-Risk Surgery Patients Specialty Sets: Cardiology Comment: One commenter did not support measure Q322: Cardiac Stress Imaging Not Meeting Appropriate Use Criteria: Preoperative Evaluation in Low-Risk Surgery Patients. While this measure promotes appropriate use of cardiac stress imaging in low-risk surgery patients and cites clinical recommendations on perioperative evaluation of patients undergoing non-cardiac surgery to form the basis of the measure, developers do not cite a performance gap. Additionally, the denominator population is not specified for individual clinician use and clinicians may misinterpret the measure as currently written. The commenter recommended that developers consider revising the numerator to include cardiac stress images performed within 30 days preceding low-risk, non-cardiac surgery and the denominator specifications to include asymptomatic patients undergoing low-risk surgery. Response: We continue to evaluate methods to display performance data. We have previously published Experience Reports to provide a detailed summary and continue to create meaningful benchmarks based on the submitted data. Performance data is evaluated annually to ensure the measure addresses a gap in care. The measure mimics the NQF #0670: Cardiac stress imaging not meeting appropriate use criteria: Preoperative evaluation in low risk surgery patients with minor updates regarding the timing of imaging assessment. The National Quality Forum indicated the level of analysis is based on the clinician, group/practice and facility data. We will provide the numerator language feedback to the measure steward. There is a numerator note included within the specification to provide submission guidance. We appreciate the revision suggestion to clarify the numerator, but the measure still addresses appropriate use ofhealthcare resources. Q324: Cardiac Stress Imaging Not Meeting Appropriate Use Criteria: Testing in Asymptomatic, Low-Risk Patients Specialty Sets: Cardiology Comment: One commenter did not support measure Q324: Cardiac Stress Imaging Not Meeting Appropriate Use Criteria: Testing in Asymptomatic, Low-Risk Patients. The commenter stated that the numerator is not specified for individual clinician use, the measure does not specify a standardized approach to risk assessment, and it relies on the individual clinician's ability to appropriately document level of risk. Clinicians attest to the accuracy of their estimation by submission, but a stronger measure may specify a more systematic approach to risk assessment. Developers should consider revising the numerator specifications to include "healthy, low-risk patients." Response: The measure directs clinicians should consider the maximum number of available patient factors used to estimate risk based on Framingham (ATP III criteria), typically age, gender, diabetes, smoking status, and use of blood pressure medication, and integrate age appropriate estimates for missing elements, such as LDL or standard blood pressure. The measure mimics the NQF #0672: Cardiac Stress Imaging Not Meeting Appropriate Use Criteria: Testing in Asymptomatic, Low-Risk Patients with language updates. The National Quality Forum indicated the level of analysis is based on the clinician, group/practice and facility data. We will provide the numerator language feedback to the measure steward. We appreciate the revision suggestion to clarify the numerator, but the measure still addresses appropriate use of healthcare resources. Q325: Adult Major Depressive Disorder (MDD): Coordination of Care of Patients with Specific Comorbid Conditions Specialty Sets: Mental/Behavioral Health Comment: One commenter did not support measure Q325: Adult Major Depressive Disorder (MDD): Coordination of Care of Patients with Specific Comorbid Conditions, citing a lack of high quality evidence examining the impact of disease communication on meaningful clinical outcomes. Additionally, the measure specifications do not include appropriate exclusion criteria for patients with mild or stable depression. It is also burdensome for clinicians to retrieve specialists' reports for all patient visits, especially if the primary care clinician did not refer the patient to care. Response: The cited guidelines recommend with substantial clinical confidence, patients with major depressive disorder will be evaluated by or receive treatment from other eligible clinicians in addition to the psychiatrist or behavioral health provider. If more than one eligible clinician is involved in providing the care, all treating clinicians should have sufficient ongoing contact with the patient and with each other to ensure that care is coordinated, relevant information is available to guide treatment decisions, and treatments are synchronized. In response to the concern of the diagnosis criteria, the diagnosis codes indicate major depressive disorder and need to be active at the date of the encounter. We disagree commenters concern that the measure is burdensome for eligible clinicians to retrieve specialists' reports. The intent of the measure is to promote care coordination by requiring the eligible clinician treating MDD to provide relevant information to the clinician treating the comorbid condition. Q326: Atrial Fibrillation and Atrial Flutter: Chronic Anticoagulation Therapy Specialty Sets: Cardiology, Family Medicine, Internal Medicine, Skilled Nursing Facility Response: The denominator exclusion removes patients that have mitral stenosis, prosthetic heart valves, or transient or reversible cause of atrial fibrillation. Any documentation meeting the defined criteria would remove the patient from the measure and would not be evaluated for anticoagulation therapy. The 2018 VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00442 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.259</GPH> amozie on DSK3GDR082PROD with RULES3 Comment: One commenter supported measure Q326: Atrial Fibrillation and Atrial Flutter: Chronic Anticoagulation Therapy but stated that inclusion of broad exclusion criteria may discourage clinicians from prescribing therapy in patients where the benefits outweigh the risk of harms. The commenter suggested this issue be addressed by developers by explicitly defining denominator exclusion criteria to prevent underuse of anticoagulation therapy in clinically appropriate cases, and that denominator specifications should be updated to include the CHADs2VASc risk stratification tool. Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60277 MISCELLANEOUS PUBLIC COMMENTS AND RESPONSES Note: The following table summarizes public comments received that are general to individual MIPS measures but not specific to newly proposed measures, specialty measure sets, measures proposed for removal, or measures with substantive changes. measure specification was updated in during the previous measure revision cycle to utilize the CHADs2VASc risk stratification tool. Q331: Adult Sinusitis: Appropriate Choice of Antibiotic Prescribed for Acute Sinusitis (Overuse) Specialty Sets: Family Medicine, Internal Medicine, Emergency Medicine, Otolaryngology, Urgent Care, Comment: One commenter did not support measure Q331: Adult Sinusitis: Appropriate Choice of Antibiotic Prescribed for Acute Sinusitis (Overuse). They cited that numerator specifications do not define an appropriate performance rate and a 0 percent performance rate will promote underuse of antibiotic therapy in appropriate treatment cases. Furthermore, the numerator specifications define "acute sinusitis" according to typical bacterial infection symptoms and it is appropriate to prescribe antibiotics to treat a bacterial infection. The commenter suggested that developers should consider revising denominator specifications to define "acute sinusitis" according to viral symptoms to prevent overuse of antibiotic therapy in viral sinusitis infections, and to align the measure with current clinical recommendations. The commenter supported inclusion of appropriate exclusion criteria, but cites that inclusion of broad exclusion criteria may provide opportunity for measure manipulation by reporting clinicians. Response: The Centers for Disease Control and Prevention identifies that 98 percent of rhino sinusitis cases are viral. Treatment of these cases with antibiotics may increase patient harm and lead to antibiotic resistance. The numerator note adds clarification for inverse measures, which indicates as the performance rate trends towards 0 percent, quality increases. In response to manipulation of data, any claims submitted to the CMS are subject to an audit, inclusive of any performance data submitted to the quality program. The measure is specific to viral sinusitis, we do not agree that it promotes underuse of antibiotic therapy in the appropriate cases. The clinical recommendation within the measure specification includes diagnosis of acute bacterial rhino sinusitis when symptoms persist for at least 10 days or worsening of symptoms after initial improvement. The measure includes a denominator exception for a documented reason for antibiotic regimen prescribed within 10 days of symptom onset, which is appropriate for this inverse measure. Q332: Adult Sinusitis: Appropriate Choice of Antibiotic: Amoxicillin with or without Clavulanate Prescribed for Patients with Acute Bacterial Sinusitis (Appropriate Use) Specialty Sets: Family Medicine, Internal Medicine, Emergency Medicine, Otolaryngology, Urgent Care Comment: One commenter did not support measure Q332: Adult Sinusitis: Appropriate Choice of Antibiotic: Amoxicillin with or without Clavulanate Prescribed for Patients with Acute Bacterial Sinusitis (Appropriate Use) as numerator specifications do not align with specialty society recommendations. The commenter suggested that developers update the measure specifications to encourage prescription of amoxicillin-clavulanate as first-line therapy in patients diagnosed with bacterial sinusitis. In addition, the measure specifications do not include exclusion criteria for patients who do not tolerate amoxicillin. About 30-40 percent of patients are bacterial resistant to amoxicillin therapy alone. Response: The measure specification does include a denominator exception for a documented reason for not prescribing amoxicillin. The IDSA identifies their clinical recommendation of use of Amoxicillin-clavulanate rather than amoxicillin alone weighted as low strength and weak quality of evidence. The Centers for Disease Control and Prevention continue to recommend Amoxicillin or amoxicillin!clavulanate as the recommended frrst-line therapy in confirmed cases of bacteria sinusitis. Q333: Adult Sinusitis: Computerized Tomography (CT) for Acute Sinusitis (Overuse) Specialty Sets: Family Medicine, Internal Medicine, Emergency Medicine, Otolaryngology, Urgent Care Comment: One commenter supported measure Q333: Adult Sinusitis: Computerized Tomography (CT) for Acute Sinusitis (Overuse) because it is clinically important to promote appropriate use of CT scans in patients diagnosed with acute sinusitis. However, the commenter stated that developers do not clearly define denominator exclusion criteria and as such, implementation could promote underuse of CT scans in clinically appropriate cases. Developers should consider revising exclusion criteria based on current guidelines. Response: The measure includes a denominator exception for documented reasons of a CT scan ordered at the time of diagnosis which is appropriate for this inverse measure and would allow for use of CT scan for appropriate cases. We refer the commenter to the clinical recommendation statements within the measure specification that indicate that clinicians should not obtain radiographic imaging for patients presenting with uncomplicated acute rhino sinusitis (ARS) to distinguish ABRS from VRS, unless a complication or alternative diagnosis is suspected. Radiographic imaging ofthe paranasal sinuses is unnecessary for diagnosis in patients who already meet clinical diagnostic criteria for ABRS. Sinus involvement is common in documented viral URis, making it impossible to distinguish ABRS from VRS based solely on imaging studies. This measure is intended to avoid costly diagnostic tests that do not improve diagnostic accuracy yet expose the patient to unnecessary radiation. Q342: Pain Brought under Control within 48 Hours Specialty Sets: Family Medicine, Internal Medicine Response: The measure is intended to evaluate the effectiveness and timeliness of initial pain management after the start of palliative care services vs. immediate pain control. It strives to incorporate the patient's pain goals relative to perception of comfort rather than aiming for a specific numeric pain intensity rating. This is not a required measure and encourage eligible clinicians to select clinically appropriate measures. Q357: Surgical Site Infection (SSI) VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00443 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.260</GPH> amozie on DSK3GDR082PROD with RULES3 Comment: One commenter did not support measure Q342: Pain Brought under Control within 48 Hours as it is unclear whether implementation will produce reliable, meaningful results, and there is insufficient evidence to support the 48 hour time interval. Additionally, the specifications include an assessment tool is that is not well validated. Measure developers should consider modirying the specifications to include a more appropriate assessment tool (for example, Numeric Pain Rating Scale). The commenter stated this is an inappropriate internal medicine accountability measure. 60278 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations MISCELLANEOUS PUBLIC COMMENTS AND RESPONSES Note: The following table summarizes public comments received that are general to individual MIPS measures but not specific to newly proposed measures, specialty measure sets, measures proposed for removal, or measures with substantive changes. Specialty Sets: Otolaryngology, General Surgery, Vascular Surgery Comment: One commenter noted the Q357: Surgical Site Infection (SSI) measure lacks rigor, and the chance for misclassification of surgeons is high. The commenter stated that standardized risk adjustment methodologies are critical when comparing clinical outcomes across different registries/cohorts, yet surgical MIPS measures do not account for risk factors. For example, the commenter tested the SSI measure collected through the ACS Surgeon Specific Registry (SSR). The commenter compared the unadjusted SSI measure rates to the risk-adjusted SSI rates and found that approximately 50 percent of cases were misclassified when risk adjustment was not performed. Yet, CMS does not require the risk adjustment of the SSI measure. Response: This measure is constructed so that risk adjustment is performed by the parsimonious dataset and aims to allow efficient data collection resources and data submission. In the prior PQRS program, risk-adjustment methodology was provided to vendors if they wanted to provide their clients with this comparison to other eligible clinicians. We do understand the concern of disparities and discussing mitigation strategies to not hold eligible clinicians to different standards for the outcomes of their patients with risk factors or degree of invasiveness. We do not want to mask potential disparities or minimize incentives to improve the outcomes for different patient populations and procedures. However, at this time, we do not require measures to be risk-adjusted. We believe this is still a valid measure to maintain within the program as the denominator is restricted. We will provide this feedback to the measure steward but encourage the commenter to collaborate with the measure steward as well. Q370: Depression Remission at Twelve Months Specialty Sets: Family Medicine, Internal Medicine, Mental/Behavioral Health, Geriatrics Comment: One commenter did not support measure Q370: Depression Remission at Twelve Months, citing that the measure does not account for individual starting points for each patient and there is a lack of high-quality evidence to support the 12-month (+/- 30 days) time interval. The threshold of reaching a specific PHQ-9 score (<5) is arbitrary and does not take into account the individual starting points for each patient. The measure may unfairly penalize clinicians caring for severely depressed patients for their inability to satisfy the measure requirements and as such, this measure may encourage clinicians to overtreat patients for major depressive disorder. Many patients are unable to achieve a PHQ-9 score of <5 and the PHQ-9 is not necessarily the best tool to track patient remission. The commenter suggested that developers consider revising the denominator specifications to include additional depression remission tracking tools and that measure specifications exclude patients with dementia or severe cognitive impairments and patients permanently residing in nursing homes. Lastly, the commenter would be amenable to using this measure as a tracking mechanism but opposed any linkage to performance and payment. Response: This measure is not intended to assess the depression response, but the remission. Full remission is defined as a 2-month period devoid of major depressive signs and symptoms (American Psychiatric Association, 2013). If using a PHQ-9 tool, remission translates to PHQ-9 score ofless than 5 (Kroenke, 2001). We agree that depression response and remission take time. In the STAR*D study, longer times than expected were needed to reach response or remission. In fact, one-third of those who ultimately responded did so after 6 weeks. Of those who achieved remission by Quick Inventory of Depressive Symptomatology (QIDS), 50 percent did so only at or after 6 weeks of treatment (Trivedi, 2006). If the eligible clinician is seeing improvement, this measure encourages the continuation of treatment to reach remission. This can take up to 3 months. Relapse is common within the first 6 months following remission from an acute depressive episode; as many as 20-85 percent of patients may relapse (American Psychiatric Association, 2010). For that reason, we agree with the remission outcome be assessed at multiple points in time. Q371: Utilization of the PHQ-9 Tool Specialty Sets: Family Medicine, Internal Medicine, Mental/Behavioral Health Comment: One commenter did not support measure Q37l: Utilization of the PHQ-9 Tool although it is clinically important and could lead to the development of an accurate outcome measure by determining well validated levels of depression severity. The commenter stated there is insufficient evidence to support the 4-month time interval specified in the denominator and the 4-month measurement period is unclear as to whether it's one measurement within a 4-month period, or every 4 months for patients with an on-going disease diagnosis. Evidence supports utilization of the PHQ-9 tool, but many clinicians utilize additional remission screening tools that are equally as effective as the PHQ-9. The measure intends to assess performance at the system level. While this measure may appropriately assess the performance of mental health practitioners (for example, psychiatrist), it may be an inappropriate accountability measure for primary care clinicians who may encounter interoperability barriers to satisfy the measure requirements (for example, subspecialist reports). Response: We have proposed substantive changes to this measure that address the commenter's concerns. The measure has been revised to assess both adolescent patients (12 to 17 years of age) and adult patients (18 years of age or older) with a diagnosis of major depression or dysthymia who have a completed PHQ-9 or PHQ-9M tool during the performance period. Regarding the interoperability barriers for primary care clinicians, this is not a required measure and encourage eligible clinicians to select measures that are clinically appropriate and align with their clinical workflow. Q374: Closing the Referral Loop: Receipt of the Specialist Report Comment: Two commenters provided feedback on measure Q374: Closing the Referral Loop: Receipt of the Specialist Report because it could lead to an unintended consequence of encouraging unnecessary care. One commenter provided a number of suggestions for measure developers: the specifications are not well defined and should include an evidence-based time interval and some element of risk-adjustment; there is not enough evidence cited to form the basis of the measure; the outcome is based on the level of integration of the participating information system rather than on how well the individual clinician tracks the referral; the data trail for submission may vary by submitter type; it is not necessary for clinicians to close all referral loops; and the patient may not see the specialist within the measurement period causing the referring clinician to fail the measure. Lastly, this measure may become less relevant due to the use of electronic health records (EHRs ), and there is less evidence that this measure will improve care if it is implemented at the individual clinician level. One VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00444 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.261</GPH> amozie on DSK3GDR082PROD with RULES3 Specialty Sets: Cardiology, Gastroenterology, Dermatology, Family Medicine, Internal Medicine, Obstetrics/Gynecology, Ophthalmology, Orthopedic Surgery, Otolaryngology, Physical Medicine, Preventive Medicine, Neurology, Mental/Behavioral Health, Vascular Surgery, General Surgery, Thoracic Surgery, Urology, Oncology, Rheumatology Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60279 MISCELLANEOUS PUBLIC COMMENTS AND RESPONSES Note: The following table summarizes public comments received that are general to individual MIPS measures but not specific to newly proposed measures, specialty measure sets, measures proposed for removal, or measures with substantive changes. commenter recommended that CMS work with measure developers to change Q374: Closing the Referral Loop: Receipt of Specialist Report from patient-based to episode-based because reports are associated with a specific encounter and it would reduce the timing complexity. Response: We disagree that the measure encourages unnecessary care but promotes communication between eligible clinicians. We will evaluate the request to determine an appropriate timeframe but need to consider the variance between specialties and testing. As indicated within the comment, depending on the urgency to complete the referral within a given timeframe, the patient may not see the specialist. We agree the variance oftimeframes may be mitigated by riskadjustment but may overcomplicate the measure. We disagree that performance is based on the level of integration of information systems. Referral tracking methods should be developed within individual practices or networks. In response to the request to move towards episode-based reporting, the measure is specified at the patient-level and limited to the first referral of the measurement period to minimize reporting burden on clinicians. However, we received similar feedback from stakeholders during our periodic reassessment of the measure, and we are currently testing an episode-based revision to this measure. We will consider implementing the revised measure in future program years if it continues to meet our standards for feasibility, reliability, and validity. This measure promotes communication and care coordination no matter the method of referral tracking. We maintain the notion that Q374 is still a valid measure to promote care coordination based on the responses above. Q377: Functional Status Assessment for Patients with CHF Specialty Sets: Family Medicine, Internal Medicine Comment: One commenter did not support measure Q377: Functional Status Assessment for Patients with CHF as it is unclear whether implementation of this measure will lead to meaningful improvements in quality outcomes and the measure developers do not cite a performance gap. Also, incentivizing clinicians to perform routine assessments in asymptomatic patients may result in underuse of more meaningful clinical interventions. The commenter supported valid, reliable patient reported outcome measures (PROMs), there says this measure has insufficient evidence to support the benefit of this intervention on quality outcomes. Implementation of evidence-based PROMs using validated instruments to assess clinical performance is likely the first step towards collecting PROM data. As currently specified, congestive heart failure is not clearly defined, and developers should consider revising the specifications to clearly differentiate between preserved ejection fraction and systolic dysfunction because this intervention will more likely lead to quality improvements in the latter population Response: We consulted with the measure steward and they will give consideration to providing further clarity on the definition of congestive heart failure included in the measure in the future. Q387: Annual Hepatitis C Virus (HCV) Screening for Patients who are Active Injection Drug Users Specialty Sets: Family Medicine, Internal Medicine, Infectious Disease Comment: One commenter supported measure Q387: Annual Hepatitis C Virus (HCV) Screening for Patients who are Active Injection Drug Users. The commenter agreed that the implementation will likely lead to measurable and meaningful improvements in clinical outcomes and it aligns with USPSTF recommendations and other society recommendations. The commenter advised developers to address the following concerns during the update process: the benefit of diagnosing active injection drug users on injection habits is unclear and implementation is unlikely to largely benefit population health outcomes because most clinicians treat a low patient denominator for the measure; denominator specifications may not capture patients who deny injection drug use status and denominator specifications could be revised to be more inclusive of all patients at risk for HCV (for example, baby-boomer populations); and clinicians may encounter barriers to data access as information systems may not automatically identify the denominator population unless end users create a specific code to capture injection drug use. Response: We will continue to monitor the level of impact to this patient population and will collaborate with the measure steward to potentially expand the patient population. However, we refer the commenter to measure Q400 One-Time Screening for Hepatitis C Virus for Patients at Risk that would include the requested patient population. We do not agree that data access will create any type of barrier. The data abstraction is not limited to a specific code or discrete data. As long as the medical record can substantiate the quality action, it would meet the intent of the measure. Q390: Hepatitis C: Discussion and Shared Decision Making Surrounding Treatment Options Specialty Sets: Gastroenterology Comment: One commenter did not support measure Q390: Hepatitis C: Discussion and Shared Decision Making Surrounding Treatment Options because it ceases to be relevant in an era of superior pharmacologic treatment advancements. Newer treatments have minimal side effects, and therefore, decisions about tolerability are no longer applicable. Furthermore, measure developers do not cite any evidence to form the basis of the measure and do not include measurement validity or reliability data in the measure report. Additionally, the numerator specifications are unclear. Developers should consider revising the specifications to define explicit "shared decision making" documentation requirements. Lastly, patients who receive government funded insurance may encounter accessibility barriers to treatment options. It may inappropriate to base treatment options on shared- decision making alone because payers play a significant role in the therapy selection process. Specialty Sets: Family Medicine, Internal Medicine, Otolaryngology, Pediatrics VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00445 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.262</GPH> amozie on DSK3GDR082PROD with RULES3 Response: To meet the measure, there must be documentation in the patient record of a discussion between the physician or other qualified healthcare professional and the patient that includes all of the following: treatment choices appropriate to genotype, risks and benefits, evidence of effectiveness, and patient preferences toward treatment. This would include the superior pharmacologic treatment with consideration to financial burden. We do understand the concern of socioeconomic disparities and discussing mitigation strategies to not hold eligible clinicians to different standards for the outcomes of their patients with social risk factors. We do not want to mask potential disparities or minimize incentives to improve the outcomes for disadvantaged populations. Q398: Optimal Asthma Control 60280 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations MISCELLANEOUS PUBLIC COMMENTS AND RESPONSES Note: The following table summarizes public comments received that are general to individual MIPS measures but not specific to newly proposed measures, specialty measure sets, measures proposed for removal, or measures with substantive changes. Comment: One commenter did not support measure Q398: Optimal Asthma Control, citing that implementation of the measure will likely prevent overuse of emergency department services to treat acute disease exacerbations. The commenter noted that measure developers did not cite enough evidence to form the basis of the measure, that measure specifications are difficult to navigate, and that the measure is not currently risk-adjusted for disease severity and socioeconomic status. Lastly, the commenter stated that the Asthma Control Test (ACT) is a best practice but it is a proprietary assessment tool. Response: We will work with the measure steward to incorporate the citation within the specification. We have been trying to reduce the burden of reporting but disagree with the commenter indicating 6 components are required. It is only requiring 3 components: well-controlled, risk of exacerbation, and emergency visits. The measure is stratified by age to accommodate the age-specific assessment tools. The measure is not risk-adjusted at this time to address socioeconomic status but do not believe this should deter eligible clinician from making every effort to accommodate patients' financial situations. Eligible clinicians could provide sample controller medication to improve asthma control. We do understand the concern of socioeconomic disparities and discussing mitigation strategies to not hold eligible clinicians to different standards for the outcomes of their patients with social risk factors. We do not want to mask potential disparities or minimize incentives to improve the outcomes for disadvantaged populations. The ACT may be proprietary, but the measure allows for additional asthma control tools to be utilized (Asthma Control Questionnaire or Asthma Therapy Assessment Questionnaire). We continue to evaluate methods to display performance data. We have previously published Experience Reports to provide a detailed summary and continue to create meaningful benchmarks based on the submitted data. We have explored alternative asthma measures that promote controller medication therapy over quick reliever medication, but unable to implement at the clinician level at this time. We agree that the goal is to achieve 100 percent adherence and will continue to collaborate with the measure steward to raise the Percentage Days Covered (PDC) to drive quality improvement. The measure is not risk-adjusted at this time to address socioeconomic status but do not believe this should deter adherence and all efforts should be made to accommodate patients' financial situations. As indicated within the comment, eligible clinicians could provide sample medication to improve patient adherence and alleviate financial burden. Medications dispensed as samples would be included within the PDC assessment. While this may pose difficulty in abstracting by pharmacy data, the medical record should capture this provision. Within the 2018 measure specification, there is a table that defines appropriate asthma controller medications. Based on the provided response, we maintain the notion this is an appropriate measure. Q400: One-Time Screening for Hepatitis C Virns (HCV) for Patients at Risk Specialty Sets: Family Medicine, Internal Medicine, Nephrology, Infectious Medicine Comment: One commenter supported measure Q400: One-Time Screening for Hepatitis C Virus (HCV) for Patients at Risk. They agreed that a performance gap does exist, it is important to screen for HCV in patients at risk because it is a treatable disease, the measure aligns with CDC and USPSTF recommendations on screening for HCV in patients at risk and the measure specifications include appropriate exclusion criteria. However, the commenter stated that while the measure is clearly specified, clinicians may encounter interoperability barriers to patient information retrieval. One recommendation for the measure developers is to re-assess the benefit of screening all patients included in the denominator population during the measure update, particularly patients born in the years 1945-1965. Response: We will forward the commenters suggestion to restrict the screening for patients born in the years 1945-1965. One-time HCV testing is recommended for persons born between 1945 and 1965 without prior ascertainment of risk (Rating: Class I, Level B) (AASLDIIDSA, 20 17). However, the same commenter requested this population be added to measure Q387: Annual Hepatitis C Virus Screening for Patients who are Active Injection Drug Users. We will collaborate with all stakeholders to vet the appropriate patient population. The measure is currently appropriate for each separate patient populations. One requires an annual screening for high-risk active injection drug use, while the broader denominator requires a one-time screening which is appropriate for historical risk factors_(born from 1945-1965, historv of blood transfusionprior to 1992, hemodialysis, or history_of drug use). Q401: Hepatitis C: Screening for Hepatocellular Carcinoma (HCC) in Patients with Cirrhosis Specialty Sets: Gastroenterology, Family Medicine, Internal Medicine Comment: One commenter did not support measure Q401: Hepatitis C: Screening for Hepatocellular Carcinoma (HCC) in Patients with Cirrhosis because the screening benefits do not outweigh the substantial risks of harms related to radiation exposure and treatment of incidental findings. Developers cite weak evidence to form the basis of the measure, and a recent evidence review demonstrates insufficient evidence for screening for hepatocellular carcinoma among patients with cirrhosis. Response: We will continue to monitor the clinical guidelines that suggest the benefits do not outweigh the risks. In regards to the comment, to weighing the risk versus benefits, the measure allows for a denominator exception for patient and medical reasons for not completing the screening. Q402: Tobacco Use and Help with Quitting among Adolescents Specialty Sets: Cardiology, Gastroenterology, Dermatology, Family Medicine, Internal Medicine, Obstetrics/Gynecology, Orthopedic Surgery, Otolaryngology, Pediatrics, Physical Medicine, Preventive Medicine, Neurology, Mental/Behavioral Health, General Surgery, Vascular Surgery, Thoracic Surgery, Oncology, Rheumatology, Urgent Care Response: We do not agree in separating the measure into two distinct measures. We will provide your recommendation to the measure steward to stratizying the measure so to provide separate performance rates to identifY areas where a gap exists. Q408: Opioid Therapy Follow-Up and Evaluation Specialty Sets: Family Medicine, Internal Medicine, Orthopedic Surgery, Physical Medicine, Neurology, Geriatrics VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00446 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.263</GPH> amozie on DSK3GDR082PROD with RULES3 Comment: One commenter supported measure Q402: Tobacco Use and Help with Quitting among Adolescents because, tobacco use is a modifiable risk factor and clinical evidence supports patient counseling. The commenter stated the denominator population is unclear, and the developer should consider separating the measure into two distinct measures: (1) tobacco use screening measure; and (2) tobacco cessation measure for patients who screened positive on measure 1. Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60281 MISCELLANEOUS PUBLIC COMMENTS AND RESPONSES Note: The following table summarizes public comments received that are general to individual MIPS measures but not specific to newly proposed measures, specialty measure sets, measures proposed for removal, or measures with substantive changes. Comment: One commenter did not support measure Q408: Opioid Therapy Follow-Up and Evaluation as it is a "check the box measure." A more appropriate measure may incentivize a standardized, methodological approach to evaluation that is likely to improve the opioid therapy management process and result in improved clinical outcomes. There is insufficient evidence to support the 6 weeks and 3 months durations included in the denominator and numerator specifications. The commenter suggested that developers revise the specifications to include an evidence based-definition of chronic opioid therapy. Furthermore, it is unclear whether clinicians who prescribe therapy for less than 3 months should require patient follow-up earlier than 3 months' time. The measure would benefit from reliability and validity testing prior to inclusion in quality payment programs. Response: We agree with the commenter's suggestion to revise the quality action to require follow up or mitigation plan if patient is not responding or misusing the opioid. We have collaborated with the measure steward to provide a definition of follow-up evaluation included in the 2019 measure specification. We will provide the commenter's recommendation to the measure steward to align the denominator with the definition of chronic opioid therapy. However, we believe frequent patient education and follow-up regarding opioid use is necessary and aligns with our program goals to address the opioid epidemic. Q411: Depression Remission at Six Months Specialty Sets: Mental/Behavioral Health Comment: One commenter did not support measure Q411: Depression Remission at Six Months, citing a lack of high-quality evidence to support the 6-month (+/- 30 days) time interval included in the numerator specifications and the threshold of reaching a specific PHQ-9 score (<5) is arbitrary, does not take into account the individual starting points for each patient, and is difficult for patients to achieve. The measure may also penalize clinicians caring for severely depressed patients for their inability to satisfy measure requirements and as such, this measure may encourage clinicians to over treat patients for major depressive disorder. The commenter recommended that developers: should consider revising the specifications to include risk adjustment to account for individual starting points for each patient; that PHQ-9 is not necessarily the best tool to track patient remission; that denominator specifications could be revised to include additional depression remission tracking tools; and that measure specifications exclude patients with dementia or severe cognitive impairments and patients permanently residing in nursing homes. Response: This measure is not intended to assess the depression response, but the remission. Full remission is defined as a 2-month period devoid of major depressive signs and symptoms (American Psychiatric Association, 2013). If using a PHQ-9 tool, remission translates to PHQ-9 score ofless than 5 (Kroenke, 2001). We agree that depression response and remission take time. In the STAR*D study, longer times than expected were needed to reach response or remission. In fact, one-third of those who ultimately responded did so after 6 weeks. Of those who achieved remission by Quick Inventory of Depressive Symptomatology (QIDS), 50 percent did so only at or after 6 weeks of treatment (Trivedi, 2006). If the eligible clinician is seeing improvement, this measure encourages the continuation of treatment to reach remission. This can take up to 3 months. Relapse is common within the first 6 months following remission from an acute depressive episode; as many as 20-85 percent of patients may relapse (American Psychiatric Association, 2010). Q412: Documentation of Signed Opioid Treatment Agreement Specialty Sets: Family Medicine, Internal Medicine, Orthopedic Surgery, Physical Medicine, Neurology, Geriatrics Comment: One commenter supported measure Q412: Documentation of Signed Opioid Treatment Agreement because it protects clinicians from the repercussions of patients who violate the opioid agreement. Also, considering the magnitude and urgency of the opioid epidemic, quality programs should adopt this measure unless data is otherwise available to describe the negative consequences of this measure. The commenter suggested that developers update the measure specifications to include appropriate exclusion criteria for patients receiving active cancer treatment, and patients receiving palliative and end-of-life care. Response: We agree with the commenter' s suggestion to exclude patients who are undergoing active cancer treatment and who are receiving palliative and endof-life care. We have previously collaborated with the measure steward to add a hospice exclusion for the 2019 performance period. We encourage the commenter to review the measure specification when published. Q414: Evaluation or Interview for Risk ofOpioid Misuse Specialty Sets: Family Medicine, Internal Medicine, Orthopedic Surgery, Physical Medicine, Neurology, Geriatrics Comment: One commenter supported measure Q414: Evaluation or Interview for Risk ofOpioid Misuse because implementation will likely lead to measurable and meaningful improvements in patient outcomes and prevent the misuse and abuse of opioid prescription therapy. However, the commenter stated that evidence exists to suggest that opioid addiction develops in less than 6 weeks duration of prescribed therapy, so the measure could unfairly penalize clinicians who do not initiate opioid therapy. Measure developers should consider updating the denominator specifications to include an evidence-based therapy duration. Also, the opioid measures would benefit from additional testing to determine which interventions are most impactful in preventing opioid misuse and abuse, exclusion criteria could include patients receiving active cancer treatment, palliative care, and end-of-life care. Specialty Sets: Family Medicine, Internal Medicine, Obstetrics/Gynecology, Orthopedic Surgery VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00447 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.264</GPH> amozie on DSK3GDR082PROD with RULES3 Response: We agree with the commenter's suggestion to exclude patients undergoing active cancer treatment, receiving palliative and end-of-life care. We have collaborated with the measure steward to add a hospice exclusion for the 20 19 performance period. We encourage the commenter to review the measure specification when published. In addition, we will provide the commenter's recommendation to the measure steward to align the denominator with the definition of chronic opioid therapy. The revision of chronic opioid therapy does not make this an invalid measure as it promotes risk assessment for a large opioid epidemic. Q418: Osteoporosis Management in Women who had a Fracture 60282 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations MISCELLANEOUS PUBLIC COMMENTS AND RESPONSES Note: The following table summarizes public comments received that are general to individual MIPS measures but not specific to newly proposed measures, specialty measure sets, measures proposed for removal, or measures with substantive changes. Comment: One commenter supported measure Q418: Osteoporosis Management in Women who had a Fracture because a performance gap exists, the specifications align with current recommendations to screen for osteoporosis in women aged 65 years and older, and specifications include appropriate exclusion criteria for women with fracture related to traumatic injury. The commenter stated that implementation may promote overuse of bone mineral density testing, and developers should consider tapering the fracture defmition to only include women with vertebral and hip fractures. Response: We do not agree that it would promote overuse of screening as it allows a 2-year timeframe for completing the bone mineral density test. In addition, an eligible clinician can meet the intent of the measure by pharmacotherapy. Eligible clinicians are expected to coordinate their care with eligible clinicians. We will provide feedback to the measure steward regarding the narrowing of eligible ICDlO codes and possibly incorporated in a future annual revision process. In response to the commenter' s request to include a hospice exclusion, this is included within the measure specification. Comment: For measure Q418: Osteoporosis Management in Women Who Had a Fracture, one commenter stated that there is a disconnect between this quality measure and the communication and care transition quality measure application to the clinician treating the fracture. The commenter urged CMS to align measure Q418 with clinical guidelines recommending that patients with a history of hip or vertebral fracture receive (or are offered) pharmacotherapy to treat osteoporosis. Response: This measure promotes further evaluation or pharmacotherapy to treat osteoporosis for patients experiencing a fracture. U.S. Food and Drug Administration approved pharmacologic options for osteoporosis prevention and/or treatment of postmenopausal osteoporosis include, in alphabetical order: bisphosphonates (alendronate, alendronate-cholecalciferol, ibandronate, risedronate, zoledronic acid, calcitonin, teriparatide, denosumab, and raloxifine. Q419: Overuse of Imaging for Patients with Primary Headache and a Normal Neurological Evaluation Specialty Sets: Neurology Comment: One commenter supported measure Q419: Overuse oflmaging for Patients with Primary Headache and a Normal Neurological Evaluation. However, the commenter stated that measure developers cite outdated evidence to form the basis of the measure. Additionally, quality reporting programs should be aware of the potential for clinicians to manipulate the measure to work in their favor by documenting an exception to the rule (for example, "change in the type of headache"). To avoid potential measure gaming, developers should consider revising the specifications to clearly defme appropriate exceptions to eligibility. Response: In response to the outdate guidelines concern, we encourage the commenter to review the substantively updated measure specification that reflect the most recent guidelines. Eligible clinicians should not change their billing or documentation to manipulate eligibility or performance. Any claims submitted to the CMS are subject to an audit, inclusive of any performance data submitted to the quality program. Q431: Preventive Care and Screening: Unhealthy Alcohol Use: Screening & Brief Counseling Specialty Sets: Cardiology, Gastroenterology, Family Medicine, Internal Medicine, Obstetrics/Gynecology, Otolaryngology, Physical, Medicine, Preventive Medicine, Mental/Behavioral Health, Urology, Oncology, Urgent Care Comment: One commenter supported measure Q431: Preventive Care and Screening: Unhealthy Alcohol Use: Screening & Brief Counseling because it is clinically important to screen for unhealthy alcohol use. They agreed that the measure aligns with the United States Preventive Services Task Force (USPSTF) recommendations on screening and behavioral health counseling interventions in primary care, and the measure does not pose undue burden on clinicians. The commenter suggested the developers revise the numerator specifications to clearly define "brief counseling. Response: We direct the commenter to the measure specification that defines brief counseling: Brief counseling for unhealthy alcohol use refers to one or more counseling sessions, a minimum of 5-15 minutes, which may include: feedback on alcohol use and harms; identification of high risk situations for drinking and coping strategies; increased motivation and the development of a personal plan to reduce drinking. Q435: Quality of Life Assessment for Patients with Primary Headache Disorders Specialty Sets: Neurology Comment: One commenter did not support measure Q435: Quality of Life Assessment for Patients with Primary Headache Disorders because it cannot estimate the measure impact on improved clinical outcomes. The commenter stated that following on the measure specifications: denominator specifications include exclusion criteria for patients without insurance to cover assessment costs, reinforcing uncertainty surrounding the intervention's ability to improve quality outcomes; the numerator specifies an assessment tool that is specific to migraine headaches; and as currently specified, clinicians are required to perform quality of life assessments on all patients with primary headache disorders, regardless of clinical relevance to the patient's primary complaints. Developers should consider revising the specifications to include a principle diagnosis of primary headache and more meaningful, evidence-based interventions. Specialty Sets: Cardiology, Family Medicine, Internal Medicine, Preventive Medicine VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00448 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.265</GPH> amozie on DSK3GDR082PROD with RULES3 Response: We disagree with the commenter's assessment of the measure and refer the commenter to review the MIPS quality measure. It does not have an exclusion for patients without insurance to cover assessment costs. The measure does provide a list of quality of life tools applicable to this specific patient population: Migraine Disability Assessment (MIDAS) and PedMIDAS (proprietary); Headache Impact Test-6 (HIT-6)(proprietary); Migraine Specific Quality of Life Tool (MSQ); Neck Disability Index (NDI)-used for cervicogenic headaches; McGill Questionnaire. This measure may be submitted by eligible clinicians who perform the quality actions described in the measure based on the services provided and the measure-specific denominator coding. The eligible clinician would only submit the measure if there was a qualifying encounter(s). Q438: Statin Therapy for the Prevention and Treatment of Cardiovascular Disease Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60283 MISCELLANEOUS PUBLIC COMMENTS AND RESPONSES Note: The following table summarizes public comments received that are general to individual MIPS measures but not specific to newly proposed measures, specialty measure sets, measures proposed for removal, or measures with substantive changes. Comment: One commenter supported measure Q438: Statin Therapy for the Prevention and Treatment of Cardiovascular Disease based on an increase in the performance gap due to new guidelines, available evidence and that measure specifications include appropriate exclusion criteria for patient intolerance. The commenter noted that implementation of statin therapy alone does not guarantee meaningful improvements in clinical outcomes. A more meaningful measure may examine patient adherence to prescribed statin therapy. Additionally, a high percentage of patients prescribed statin therapy for the management of cardiovascular disease exacerbations (for example, acute MI) discontinue therapy without consulting their clinician. However, the measure may unfairly penalize clinicians for lack of control over non-adherent patients. Response: We will evaluate the commenter's request for adding an adherence component, but the commenter also cited concerns that this may not attribute to the eligible clinician due to lack of control of non-adherent patients. Based on the commenter's feedback to add adherence but caution adherence would out of the eligible clinician's control, we maintain the notion this is a good measure, Q441: Ischemic Vascular Disease: All or None Outcome Measure Specialty Sets: Cardiology, Family Medicine, Internal Medicine, Vascular Surgery Comment: One commenter did not support measure Q441: Ischemic Vascular Disease: All or None Outcome Measure, citing that it did not receive adequate information from the developer for review and that it rated the measure based on the specifications provided on the MIPS website. The commenter stated the measure because it disregards patient preferences, specifications do not consider factors beyond the clinician's control, and it does not align committee recommendations for hypertension management. Response: We agree with updating the numerator to reflect the updated blood pressure values and have been discussing the revision with the measure steward. We maintain the opinion this is a good measure since the new guidelines have been controversial and encourages comprehensive management of a prevalent condition. Q442: Persistence of Beta-Blocker Treatment after a Heart Attack Specialty Sets: Cardiology, Family Medicine, Internal Medicine Comment: One commenter supported measure Q442: Persistence of Beta-Blocker Treatment after a Heart Attack, citing high-quality evidence from the most recent recommendations of various organizations. The commenter noted this measure is close to being topped out. Response: We encourage the commenter to review the most current MIPS performance data when available. Q443: Non-Recommended Cervical Cancer Screening in Adolescent Females Specialty Sets: Family Medicine, Internal Medicine, Obstetrics/Gynecology Comment: One commenter supported measure Q443: Non-Recommended Cervical Cancer Screening in Adolescent Females because implementation will likely promote appropriate use of cervical cancer screening in adolescents, the measure is well specified, and specifications include appropriate exclusion criteria for women diagnosed with HIV. The measure also aligns with USPSTF recommendations on cervical cancer screening. However, the commenter noted that earlier screening is not as effective and that the evidence base would benefit from re-evaluation as data surfaces on the benefits and risks of screening in women < 20 years old. Because the performance gap is not cited in the measure report, it is difficult to estimate the potential impact of the measure on quality outcomes. Response: We continue to evaluate methods to display performance data. We have previously published Experience Reports to provide a detailed summary and continue to create meaningful benchmarks based on the submitted data. The measure aligns with United States Preventive Services Task Force recommendations on cervical cancer screening in addition to the ACOG and ASCCP guidelines. We will continue to monitor for updated cervical cancer screening guidelines and collaborate with the measure steward to align with any updated guidelines. Q444: Medication Management for People with Asthma Specialty Sets: Family Medicine, Internal Medicine, Pediatrics Response: We continue to evaluate methods to display performance data. We have previously published Experience Reports to provide a detailed summary and continue to create meaningful benchmarks based on the submitted data. We have explored alternative asthma measures that promote controller medication therapy over quick reliever medication, but unable to implement at the clinician level at this time. We agree that the goal is to achieve 100 percent adherence and will continue to collaborate with the measure steward to raise the Percentage Days Covered (PDC) to drive quality improvement. The measure is not riskadjusted at this time to address socioeconomic status but do not believe this should deter adherence and all efforts should be made to accommodate patients' financial situations. We do understand the concern of socioeconomic disparities and discussing mitigation strategies to not hold eligible clinicians to different standards for the outcomes of their patients with social risk factors. We do not want to mask potential disparities or minimize incentives to improve the outcomes for disadvantaged populations. As indicated within the comment, eligible clinicians could provide sample medication to improve patient adherence VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00449 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.266</GPH> amozie on DSK3GDR082PROD with RULES3 Comment: One commenter supported measure Q444: Medication Management for People with Asthma because implementation may promote patient adherence to prescribed controller medication therapy. However, the commenter indicated the following concerns: the performance gap is not cited; there is no evidence cited to support the Percentage of Days Covered (PDC) threshold; the measure is not measure is not risk-adjusted for disease severity or socioeconomic status and implementation; the measure numerator should clearly specizy an appropriate asthma controller medication list; the measure could unfairly penalize clinicians who encounter interoperability barriers to data retrieval; the measure uses pharmacy data to track medication adherence where lower socioeconomic patients may encounter cost barriers and adherence issues; and lastly, the measure assesses quality at the system level where individual clinicians may encounter interoperability barriers to data retrieval. 60284 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations MISCELLANEOUS PUBLIC COMMENTS AND RESPONSES Note: The following table summarizes public comments received that are general to individual MIPS measures but not specific to newly proposed measures, specialty measure sets, measures proposed for removal, or measures with substantive changes. and alleviate financial burden. Medications dispensed as samples would be included within the PDC assessment. While this may pose difficulty in abstracting by pharmacy data, the medical record should capture this provision. Within the 2018 measure specification there is a table that defines appropriate asthma controller medications. Based on the provided response, we maintain the notion this is an appropriate measure. Specialty Measure Sets: Cardiology, General Surgery, Skilled Nursing Facility Comment: One commenter encouraged CMS to add the following immunization quality measures into a new Endocrinology specialty measure sets: • Cardiology- Q474: Zoster (Shingles) Vaccination; Q110: Preventive Care and Screening: Influenza Immunization and Q111: Pneumonia Vaccination Status for Older Adults • General Surgery- Q110: Preventive Care and Screening: Influenza Immunization and Q111: Pneumonia Vaccination Status for Older Adults • Skilled Nursing Facility-. Q111: Pneumonia Vaccination Status for Older Adults • Endocrinology - Q474: Zoster (Shingles) Vaccination; Preventive Care and Screening: Influenza Immunization and Q 111: Pneumonia Vaccination Status for Older Adults Response: We thank the commenter for the recommendation to create an Endocrinology specialty measure set and to add these measures to existing specialty measure sets for Cardiology, General Surgery, and Skilled Nursing Facility. Prior to rulemaking we solicit feedback from stakeholders with regards to measures that should be added or removed to existing specialty sets or the development of new specialty sets. Specific measure to create an Endocrinology specialty measure set were not suggested as part of the feedback received from specialty stakeholders for the 2019 performance period. We ask the commenter to submit their feedback during this solicitation process for future consideration in rulemaking. This allows stakeholder to provide feedback to the specialty set proposed prior to the fmalization of the specialty set. We do not agree with the recommendation to include Q110, Q111, and Q474 to the Cardiology and General Surgery specialty sets as the patient would likely be referred to the PCP to receive immunizations. While we agree that Q111 may apply to Skilled Nursing Facilities, the denominator coding does not support this request. Specialty Measure Set: Allergy/Immunology (All) Comment: One commenter expressed concerns with the Allergy/Immunology (All) Specialty Measure Set, which they noted includes measures that are not pertinent to our Allergy/Immunology Specialty. Given All specialists do not diagnose, treat or manage IDVIAIDS, measures related to this disease do not belong in the All Specialty Measure Set. Therefore, the commenter requested that CMS remove the following measures: Measure 160: IDV/AlDS: Pneumocystis Jiroveci Pneumonia (PCP) Prophylaxis; Measure 338: HIV Viral Load Suppression; Measure 340: IDV Medical Visit Frequency. In addition, the commenter noted that All specialists do diagnose, treat and frequently manage sinusitis and asthma, therefore, they requested that CMS return the following measures to the All Specialty Measure Set: Measure 331: Adult Sinusitis: Antibiotic Prescribed for Acute Sinusitis, Measure 332: Adult Sinusitis: Appropriate Choice of Antibiotic. Response: Prior to rulemaking we solicit feedback from stakeholders with regards to measures that should be added or removed to existing specialty sets or the development of new specialty sets. The suggestion to remove the measures from the Allergy/Immunology specialty measure set was not provided as part of the feedback received from specialty stakeholders for the 2019 performance period. We ask the commenter to submit their feedback during this solicitation process for future consideration in rulemaking. Specialty Measure Set: Dentistry Comment: One commenter supported the inclusion of measure Q379: Primary Caries Prevention Intervention as Offered by Primary Care Providers, including Dentists, but stated the measure specifications do not reflect the best clinical evidence. Existing clinical recommendations recommend that topical fluoride be applied more frequently than once per year and as often as every 3 months for children at elevated risk for dental caries. The commenter recommended that this measure be amended to reflect increased risk for tooth decay in line with the existing pediatric measure set developed by the Dental Quality Alliance (DQA). The commenter also supported the inclusion of measure Q378: Children Who Have Dental Decay or Cavities, as it represents the type of outcome measures that oral health care has long been lacking. However, there has been no visible progress in developing or testing this measure for use by Medicaid programs. The commenter requested that CMS transfer the measure stewardship for measures Q3 78 and Q379 to the DQA, which was as established at the request of CMS to serve as a multi-stakeholder organization focused on oral health quality measurement and improvement Furthermore, the commenter noted that two additional measures have been developed by the DQA through support from the Office ofNational Coordinator for Health Information Technology (ONC) and tested for validity, reliability, feasibility and usability for use at the clinicians level and rely on standard data elements in electronic health records and are specified precisely using the Measure Authoring Tool based on the Quality Data Model and value sets. Comment: One commenter supported the inclusion of a number of dementia and cognitive impairment measures in MIPS. The commenter urged CMS to develop quality measures related to mild cognitive impairment and its detection for future years. The commenter further urged CMS to include the cognitive impairment quality measures currently under development by the measure steward when they are finalized. The commenter also stated that cognitive impairment detection is the only aspect of the Annual Wellness Visit that is not fully reinforced with clinicians through MIPS quality measures. The existing VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00450 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.267</GPH> amozie on DSK3GDR082PROD with RULES3 Response: We thank the commenter for feedback that this outcome measure is not risk adjusted for clinical or sociodemographic factors. We support the goal of identifying and reducing disparities in health and healthcare. We will explore risk adjustment for this measure and the potential impact on clinician burden in the next update period. Thank you for bringing up the current evidence-based clinical recommendations and the need to incorporate within this measure. We will review these recommendations in the next update period. With regard to the DQA and measure stewardship, we seek collaborative partnerships and engagement with stakeholders in the development and continued maintenance of important, feasible, reliable, valid, and useful measures and appreciates the opportunity to engage the current measure steward and other stakeholders. Thank you for your comments on the need for additional measures for dental professionals and your recommendations to improve the current program dental measures. We will take your suggestions under consideration as we continue to review and update program measures. We provide opportunities for introducing new measures into programs through an annual call for measures and encourage the commenter to submit measures and measure concepts at the next Call for Measures solicitation. General Comments Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60285 MISCELLANEOUS PUBLIC COMMENTS AND RESPONSES Note: The following table sunnnarizes public comments received that are general to individual MIPS measures but not specific to newly proposed measures, specialty measure sets, measures proposed for removal, or measures with substantive changes. dementia-related quality measures apply solely to patients who have already been diagnosed with dementia, and do not reflect overall incorporation ofthe required cognitive impairment component in the A WV. The Quality Payment Program, therefore, perpetuates ADRD under diagnosis and impedes appropriate interventions for patients and their families. Response: We encourage the comment to collaborate with measure developers to submit measures to the Call for Measures process for future implementation. Comment: One connnenter urged CMS to adopt the following malnutrition eCQMs adopted by the National Quality Forum 14: NQF #30871MUC16-294: Completion of a Malnutrition Screening within 24 hours of Admission; NQF #3088/MUC16-296: Completion of a Nutrition Assessment for Patients Identified as At Risk for Malnutrition within 24 hours of a Malnutrition Screening; NQF #30891MUC16-372: Nutrition Care Plan for Patients Identified as Malnourished after a Completed Nutrition Assessment; NQF #30901MUC16-344: Appropriate Documentation of a Malnutrition Diagnosis. A second connnenter indicated that given the demonstrated gap, it is critical that CMS act quickly to use its statutory authority through direction of the national quality strategy and focus on malnutrition care in the hospital. Malnutrition should be a priority area for CMS, as malnutrition care aligns with the main principles of the Meaningful Measures Initiative. Response: We encourage the connnenter to collaborate with the measure steward of the mentioned measures and submit to the Call for Measures process under the MIPS program. The referenced measures were submitted to the Hospital Inpatient Quality Reporting program, but not for MIPS consideration. Comment: One connnenter was disappointed that adult immunization quality measures were not included in a few key specialty areas who care for chronically ill patients at-risk of serious complications from vaccine preventable illness. The Advisory Committee on Innnunization Practices (ACIP) includes age-based, as well as condition-specific recommendations for adult vaccination. For pregnant women, ACIP reconnnends a Tdap vaccination. We are pleased that efforts to develop a composite Tdap/influenza measure for pregnant women has completed testing and is now under review by the National Connnittee for Quality Assurance (NCQA). The connnenter noted they look forward to further dialogue with CMS on this topic as it moves forward. In addition, patients living with chronic conditions such as heart disease and diabetes are at a significantly higher risk of complications and death from influenza and pneumonia. The CDC has reported that in 2013 only 21.2 percent of adults in this group had received a pneumococcal vaccination, and this number has remained unchanged for at least a decade. Individuals with diabetes are at increased risk for hepatitis B infection. As such, the ACIP recommends hepatitis B vaccination for all patients with diabetes age 6011 and under, as well as other at-risk patients, such as those living with HIVIAIDS and chronic kidney disease. Response: We appreciate the support for the pneumococcal quality measures. We agree this is an important public health issue. We continue to explore opportunities to implement a composite adult vaccination measure for future implementation. We encourage the connnenter to work with measure developers to submit the immunization measures to the Call for Measures process. We did add adult immunization measures to the existing Oncology and Internal Medicine specialty measure set, as well as new specialty measure set. Comment: A few commenters supported the proposal to remove six measures from CMS Web Interface reporting criteria. Response: We thank the commenters for their support. Note: Because measure Q318 is not finalized for removal from the MIPS program in this final rule, there are now five measures that will be fmalized in this final rule with the change to remove the CMS Web Interface data collection type. Comment: Concerning the quality category proposed to be weighted at 45 percent in Year 3 continuing to represent the performance category with the greatest contribution to a clinician's final score in MIPS, commenters noted that this performance category still represents the greatest challenge for chiropractic clinicians due to the limited CPT codes the provider is reimbursed by CMS. These codes are currently limited to two clinical quality measures, specifically# 131 & #182. These measures have a high risk of being removed based on the proposed rule for topped out measures in Year 3, leaving the chiropractic clinician forced to bill his/her Medicare patients out of pocket expenses to report other quality measures. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00451 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.268</GPH> amozie on DSK3GDR082PROD with RULES3 Response: We encourage stakeholders to submit feedback on specific MIPS quality measures where they believe codes should be added to reflect a specialty practice not currently reflected in a given measure. We would take that feedback into consideration, and if we agree with the recommendation, could communicate such recommendations to the measure stewards for their consideration. MIPS eligible clinicians should report on quality measures that are meaningful to their practice and within the scope of the care they provide. We note that chiropractor clinician codes have been added to the following measures for the 2019 performance period: Quality ID# 217: Functional Status Change for Patients with Knee Impairments; Quality ID# 218: Functional Status Change for Patients with Hip Impairments; Quality ID# 219: Functional Status Change for Patients with Foot or Ankle Impairments; Quality ID#220: Functional Status Change for Patients with Lumbar Impairments; Quality ID#221: Functional Status Change for Patients with Shoulder Impairments; Quality ID#222: Functional Status Change for Patients with Elbow, Wrist or Hand Impairments; and Quality ID#223: Functional Status Change for Patients with Other General Orthopaedic Impairments. We remind all clinicians that they should bill Medicare only for services that are reasonable and necessary. We encourage MIPS eligible clinicians to review the list of MIPS quality measures and QCDR measures available for quality reporting in order to report on measures that are meaningful to their scope of practice. We believe it is important to gradually remove topped out measures from the program as they demonstrate high, unvarying performance with no gaps for quality improvement. 60286 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations APPENDIX 2: Improvement Activities NOTE: For previously finalized improvement activities, we refer readers to the finalized Improvement Activities Inventory in Table Fin the Appendix of the CY 2018 Quality Payment Program final rule (82 FR 54175) and in Table H in the Appendix of the CY 2017 Quality Payment Program final rule (81 FR 77818). Unless modified or removed in the CY 2019 Physician Fee Schedule final rule, previously finalized improvement activities continue to apply for the MIPS CY 2019 performance period and future years. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00452 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.269</GPH> amozie on DSK3GDR082PROD with RULES3 We refer readers to the CY 2018 Quality Payment Program final rule (82 FR 53569) for previously adopted criteria for nominating new improvement activities. We refer readers to section III.I.3.h.(4)(d)(i) of this final rule, where we are finalizing our proposals to add one new criterion and remove a previously adopted criterion. In addition, we refer readers to section III.I.3.h.(4)(d)(i) of this final rule where we clarify: (1) considerations for selecting improvement activities for the CY 2019 performance period and future years; and (2) the weighting of improvement activities. In the CY 2019 PFS proposed rule (83 FR 36359), for CY 2019 performance period and future years we proposed: six (6) new improvement activities; the modification of five (5) existing activities; and the removal of one ( 1) existing activity. These are discussed in greater detail below. Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60287 TABLE A: New Improvement Activities for the MIPS CY 2019 Performance Period and Future Years In order to receive credit for this activity, MIPS eligible clinicians must promote the importance of a comprehensive eye exam, which may be accomplished by providing literature and/or facilitating a conversation about this topic using resources such as the "Think About Your Eyes" campaign84 and/or referring patients to resources providing no-cost eye exams, such as the American Academy of Ophthalmology's EyeCare America85 and the American Optometric Association's VISION USA. 86 This activity is intended for: (1) nonophthalmologists/optometrist who refer patients to an ophthalmologist/optometrist; (2) ophthalmologists/optometrists caring for underserved patients at no cost; or (3) any clinician providing literature and/or resources on this topic. This activity must be targeted at underserved and/or high- risk populations that would benefit from engagement regarding their eye their access to exams. health with the aim of Proposed Activity Description: This activity fills a gap as the Inventory does not currently contain an activity related to ophthalmology. Furthermore, we believe promoting and educating patients about the importance of a comprehensive eye exam can improve access to this service and, in turn, improve health status particularly for traditionally underserved populations or to those who are otherwise unable to access these important services. For these reasons, we believe this activity meets the inclusion criteria of an activity that could lead to improvement in practice to reduce health care disparities. We proposed the weighting of this activity as medium because this activity may be accomplished by providing literature and/or facilitating a conversation with a patient during a regular visit. This task may be incorporated into a patient's regular visit with a relatively low investment of time or resources Several commenters supported the inclusion of this improvement activity. Commenters stated that the activity will have positive clinical impacts on patients. In addition, routine eye exams can identify both ocular conditions as well as other health problems, including serious conditions like brain tumors, thyroid disease, and pituitary tumors. Another commenter supported improvement activities that specifically promote health equity, the goal of this improvement activity. One commenter recommended this improvement activity not be fmalized due to concern that comprehensive eye exams are not appropriate for most healthy populations and should only be targeted to those at risk. The commenter stated the improvement activity may lead to increases in unnecessary for · and low income · We believe this improvement activity will have a positive impact on patient care and promote health equity. Regarding the commenter's concern that this improvement activity may lead to the provision of comprehensive eye exams for those who are not at risk, as stated in the description, "this activity must be targeted at underserved and/or high-risk populations that would benefit from engagement regarding their eye health with the aim of improving their access to comprehensive eye exams." Therefore, we believe that the improvement activity is with the risk for conditions that Rationale: Comments: 84 The Think About Your Eyes resource at https://thinkaboutyoureyes.com. The American Academy of Ophthalmology's EyeCare America resource at https://www.aao.org/eyecare-america. 86 The American Optometric Association's VISION USA resource at https://www.aoafoundation.org/vision-usa!. 85 VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00453 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.270</GPH> amozie on DSK3GDR082PROD with RULES3 Response: 60288 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations can be detected through a comprehensive eye exam. Additionally, since comprehensive eye exams are relatively low cost interventions and early detection of conditions that can be identified through an eye exam may reduce more costly treatment later, we believe this improvement activity will not unnecessarily increase expenditures for public programs and the target Activity Description: In order to receive credit for this activity, MIPS eligible clinicians must promote the importance of a comprehensive eye exam, which may be accomplished by providing literature and/or facilitating a conversation about this topic using resources such as the "Think About Your Eyes" campaign87 and/or referring patients to resources providing no-cost eye exams, such as the American Academy of Ophthalmology's EyeCare America88 and the American Optometric Association's VISION USA. 89 This activity is intended for: (1) nonophthalmologists/optometrist who refer patients to an ophthalmologist/optometrist; (2) ophthalmologists/optometrists caring for underserved patients at no cost; or (3) any clinician providing literature and/or resources on this topic. This activity must be targeted at underserved and/or high- risk populations that would benefit from engagement regarding their eye their access to exams. health with the aim of Proposed Activity Description: In order to receive credit for this activity, MIPS eligible clinicians must attest that their practice provides fmancial counseling to patients or their caregiver about costs of care and an exploration of different payment options. The MIPS eligible clinician may accomplish this by working with other members of their practice (for example, fmancial counselor or patient navigator) as part of a teambased care approach in which members of the patient care team collaborate to support patient- centered goals. For example, a fmancial counselor could provide patients with resources with further information or support options, or facilitate a conversation with a patient or caregiver that could address concerns. This activity may occur during diagnosis stage, before treatment, during and/or · · · · · Rationale: We believe there is the possibility for improved outcomes when fmancial navigation programs are in place, such as reducing patient anxiety about costs and improved access to care for underserved populations. For these reasons, we believe this activity meets the inclusion criteria of an activity that could lead to improvement in practice to reduce health care disparities. We proposed the weighting of this activity as medium because the activity may be accomplished by providing literature and/or facilitating a conversation with a patient during a regular visit. This task may be incorporated into a patient's visit with a low investment of time orresources. 87 The Think About Your Eyes resource at https://thinkaboutyoureyes.com. The American Academy of Ophthalmology's EyeCare America resource at https://www.aao.org/eyecare-america. 89 The American Optometric Association's VISION USA resource at https://www.aoafoundation.org/vision-usa!. 88 VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00454 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.271</GPH> amozie on DSK3GDR082PROD with RULES3 co1nn1ents received, we are fmalizing this Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60289 Several commenters supported the inclusion of this improvement activity. One commenter noted that this improvement activity may be challenging for clinicians, especially those in smaller practices who have difficulty accessing cost of care data and should therefore be weighted as high. Another commenter provided support for the inclusion of this improvement activity as proposed because this improvement activity is likely to have a large impact on patients with serious illnesses who are at high risk for medical debt and its related problems, and recommended we remain flexible in the members of the patient care team that can fmancial services. As explained in section 111.1.3.h.(4)(d)(i)(C) of this final rule, the weighting of "medium" is in accordance with our policy, as high weighting should be used for activities that directly address areas with the greatest impact on beneficiary care, safety, health, and well-being and/or is of high intensity, requiring significant investment of time and resources. We do not believe accessing cost of care data requires a significant investment of time and resources, even for smaller practices, and therefore, we do not believe a high weighting is warranted. We appreciate the supportive comment that this improvement activity will have an impact on patients with serious illnesses who are at risk for medical debt. Regarding the comment that we remain flexible in the members of the patient care team that can provide fmancial navigation services, the activity description states that the MIPS eligible clinician may meet this improvement activity by working with other members ofthe patient care team, including fmancial counselors or and we intend to continue this Comments: Response: In order to receive credit for this activity, MIPS eligible clinicians must attest that their practice provides fmancial counseling to patients or their caregiver about costs of care and an exploration of different payment options. The MIPS eligible clinician may accomplish this by working with other members of their practice (for example, fmancial counselor or patient navigator) as part of a teambased care approach in which members of the patient care team collaborate to support patient-centered goals. For example, a fmancial counselor could provide patients with resources with further information or support options, or facilitate a conversation with a patient or caregiver that could address concerns. This activity may occur during diagnosis stage, before treatment, during treatment, and/or Activity Description: ° Centers for Medicare & Medicaid Services (CMS) Transforming Clinical Practice Initiative (TCPI) information at https://innovation.cms.gov/initiatives/Transforming-Clinical-Practices/. 9 VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00455 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.272</GPH> amozie on DSK3GDR082PROD with RULES3 Proposed Activity Description: 60290 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations public, in order to implement a collaborative care management approach that provides comprehensive training in the integration of behavioral health into the Collaborative care management approaches to integrating behavioral health into primary care practice have been associated with significant improvements in mental health symptom acuity and adherence to treatment in the short- to midterm. 77 78 79 In addition, this activity meets the inclusion criteria of an activity that is likely to lead to improved beneficiary health outcomes. We proposed the weighting of this activity as medium because participation in a training program consists of online reading, attending webinars, or other one-time or short-term activities, which, though beneficial, do not require substantial time or effort by clinicians. Several commenters provided general support for the new improvement activities. A few commenters supported the inclusion of this improvement Rationale: Comments: In order to receive credit for this activity, MIPS eligible clinicians must complete a collaborative care management training program, such as the American Psychological Association (APA) Collaborative Care Model training program available as part of the Centers for Medicare & Medicaid Services (CMS) Transforming Clinical Practice Initiative (TCPI), 92 available to the public, 93 in order to implement a collaborative care management approach that provides comprehensive training in the integration of behavioral health into the primary Activity Description: In order to receive credit for this activity, MIPS eligible clinicians must participate in a minimum of eight hours of training on relationship-centered care 94 tenets such as making effective open-ended inquiries; eliciting patient stories and perspectives; listening and responding with empathy; using the ART (ask, respond, tell) communication technique to engage patients, and developing a shared care plan. The training may be conducted in formats such as, but not limited to: interactive simulations practicing the skills above, or didactic instructions on how to implement improvement action plans, monitor progress, and promote stability around clinician communication. Proposed Activity Description: American Psychological Association (APA) Collaborative Care Model training program information at https://www. psychiatry .org/psychiatrists/practice/professional-interests/integrated-care/get-trained. 92 Centers for Medicare & Medicaid Services (CMS) Transforming Clinical Practice Initiative (TCPI) information at https://innovation.cms.gov/initiatives/Transforming-Clinical-Practices/. 93 American Psychological Association (APA) Collaborative Care Model training program information at https://www. psychiatry .org/psychiatrists/practice/professional-interests/integrated-care/get-trained. 94 Nundy, S. and J. Oswald (2014). "Relationship-centered care: A new paradigm for population health management." Healthcare 2(4): 216-219. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00456 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.273</GPH> amozie on DSK3GDR082PROD with RULES3 91 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60291 There is currently not an activity in the Inventory that addresses communication between patients and clinicians; this proposed activity would help fill a gap. We believe that this proposed activity meets the inclusion criteria of an activity that is likely to lead to improved beneficiary health outcomes based on research citing the importance of relationship-centered care to patient safety. 81 We proposed the weighting of this activity as medium because participation in an eight hour training on relationship-centered care, though beneficial, does not require substantial time or effort clinicians. A few commenters supported the inclusion of this improvement activity. One commenter recommended this activity be weighted high due to the potential for the to be burdensome to clinicians. As stated in section 111.1.3.h.(4)(d)(i)(C) of this fmal rule, the weighting of "medium" is in accordance with our policy, as high weighting should be used for activities that directly address areas with the greatest impact on beneficiary care, safety, health, and well-being and/or is of high intensity, requiring significant investment of time and resources. We do not believe relationship-centered trainings that can be completed in a minimum of eight hours is a significant investment of time and resources and therefore does not warrant a high Rationale: Comments: Response: cornrntenlts received, we are fmalizing this In order to receive credit for this activity, MIPS eligible clinicians must participate in a minimum of eight hours of training on relationship-centered care95 tenets such as making effective open-ended inquiries; eliciting patient stories and perspectives; listening and responding with empathy; using the ART (ask, respond, tell) communication technique to engage patients, and developing a shared care plan. Activity Description: The training may be conducted in formats such as, but not limited to: interactive simulations practicing the skills above, or didactic instructions on how to implement improvement action plans; monitor progress; and promote stability around clinician communication. In order to receive credit for this activity, MIPS eligible clinicians must provide both written and verbal education regarding the risks of concurrent opioid and benzodiazepine use for patients who are prescribed both benzodiazepines and opioids. Education must be completed for at least 75 percent of qualifying patients and occur: (1) at the time of initial co-prescribing and again following greater than 6 months of co-prescribing ofbenzodiazepines and opioids, or (2) at least once per MIPS performance period for patients taking concurrent opioid and Nundy, S. and J. Oswald (2014). "Relationship-centered care: A new paradigm for population health management." Healthcare 2(4): 216-219. 95 VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00457 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.274</GPH> amozie on DSK3GDR082PROD with RULES3 Proposed Activity Description: 60292 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations This activity addresses the Meaningful Measures priority area of Prevention and Treatment ofOpioid and Substance Use Disorders96 and addresses the role of clinicians in management of concurrent prescriptions, a topic that is not currently represented in the Inventory. We believe this activity meets the inclusion criteria of an activity that is likely to lead to improved beneficiary health outcomes due to the prevalence of opioid and substance abuse disorders and the medical consequences of mismanagement of concurrent benzodiazepine and opioid prescription. 97 We proposed the weighting of this activity as high because it addresses a public health emergenc/8 and may reduce preventable health conditions related to opioid abuse. High weighting should be used for activities that directly address areas with the greatest impact on beneficiary care, safety, health, and well-being, as explained in the CY 2017 Quality Payment Program final rule (81 FR 77194). We also refer readers to our clarifications regarding weighting at section 111.1.3.h.(4) of this fmal rule. According to the CDC, about 63,000 people died in 2016 of a drug overdose, and well over half of them are attributed to opioids. 99 Additionally, according to the 2016 National Survey on Drug Use and Health (NSDUH), 11.8 million individuals ages 12 and older misused any opioid (that is, prescription and/or illicit opioids) and 11.5 million individuals misused prescription opioids. Of those who misused opioids, 2.1 million individuals meet the criteria for an opioid use disorder. 100 Since providing education regarding the risks of concurrent opioid and benzodiazepine use directly addresses the opioid epidemic, we believe this improvement activity meets our considerations for high-weighting. Several commenters supported the inclusion of this improvement activity. A couple commenters supported the improvement activity's high weighting due to it being part of addressing the increase in opioid drug use, abuse, and overdose deaths. Other commenters provided general support for new improvement activities that address the opioid crisis. Two commenters stated that there is a lack of evidence on when the risks of concurrent opioid and benzodiazepine prescribing outweigh the benefits and likewise when the benefits outweigh the risks. We appreciate the comments of support for this improvement activity. We also appreciate the commenters who stated there is a lack of evidence on when the risks of concurrent opioid and benzodiazepine prescribing outweigh the benefits. However, this improvement activity does not require MIPS eligible clinicians to alter their prescribing protocol, except to provide written and verbal education regarding the known risks. After consideration of the public comments received, we are fmalizing this improvement activity as proposed. Rationale: Comments: Response: Rationale: Meaningful Measures Framework information available at https://www.cms.gov/Medicare/Quality-InitiativesPatient-Assessment-Instruments/QualityInitiativesGenlnfo/CMS-Quality-Strategy.html. 97 McClure, F. L., Niles, J. K., Kaufman, H. W., & Gudin, J. (2017). Concurrent Use ofOpioids and Benzodiazepines: Evaluation of Prescription Drug Monitoring by a United States Laboratory. Journal of Addiction Medicine, 11(6), 420-426. https://doi.org/1 0.1097IADM.0000000000000354. 98 Department of Health and Human Services. (2018) "HHS Acting Secretary Declares Public Health Emergency to Address National Opioid Crisis" Available at https://www.hhs.gov/about/news/2017/10/26/hhs-acting-secretarydeclares-public-health-emergency-address-national-opioid-crisis.html. 99 Hedegaard, H., Warner, M., & Minifio, A.M. (2017). NCHS Data BriefNo. 294. Center for Disease Control and Prevention National Center for Health Statistics. Available at https://www .cdc.gov/nchs/products/databriefs/db294 .htm. 100 Park-Lee, E., Lipari, R.N., Hedden, S. L., Kroutil, L.A., & Porter, J.D. (2017). Receipt of Services for Substance Use and Mental Health Issues among Adults: Results from the 2016 National Survey on Drug Use and Health. Substance Abuse and Mental Health Services Administration NSDUH Data Review. Available at https://www.samhsa.gov/data!sites/default/files/NSDUH-DR-FFR2-2016/NSDUH-DR-FFR2-2016.htm. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00458 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.275</GPH> amozie on DSK3GDR082PROD with RULES3 96 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60293 In order to receive credit for this activity, MIPS eligible clinicians must provide both written and verbal education regarding the risks of concurrent opioid and benzodiazepine use for patients who are prescribed both benzodiazepines and opioids. Education must be completed for at least 75 percent of qualifying patients and occur: (1) at the time of initial co-prescribing and again following greater than 6 months of co-prescribing ofbenzodiazepines and opioids, or (2) at least once per MIPS performance period for patients taking concurrent opioid and Activity Description: Proposed Activity Title: Proposed Activity Description: Use of CDC Guideline for Clinical Decision Support to Prescribe Opioids for Chronic Pain via Clinical Decision In order to receive credit for this activity, MIPS eligible clinicians must utilize the Centers for Disease Control (CDC) Guideline for Prescribing Opioids for Chronic Pain101 via clinical decision support (CDS). For CDS to be most effective, it needs to be built directly into the clinician workflow and support decision making on a specific patient at the point of care. Specific examples of how the guideline could be incorporated into a CDS workflow include, but are not limited to: electronic health record (EHR)-based prescribing prompts, order sets that require review of guidelines before prescriptions can be entered, and prompts requiring review of guidelines before a subsequent action can be taken in the record. This activity addresses the Meaningful Measures priority areas of Prevention and Treatment ofOpioid and Substance Use Disorders and Transfer ofHealth Information and Interoperability 102 • Electronic tools like CDS can assist clinicians in preventing adverse patient outcomes. We believe this activity meets the inclusion criteria of an activity that is likely to lead to improved beneficiary health outcomes due to the prevalence of opioid and substance abuse disorders and evidence of CDS supporting improved outcomes and patient safety. 103 We proposed the weighting of this activity as high because it promotes interoperability and addresses a public health emergency and may reduce preventable health conditions related to opioid abuse. High weighting should be used for activities that directly address areas with the greatest impact on beneficiary care, safety, health, and well-being, as explained in the CY 2017 Quality Payment Program final rule (81 FR 77194). We also refer of this readers to our clarifications at section III.I.3 Rationale: CDC Prescribing Guidelines resource at https://www.cdc.gov/drugoverdose/prescribing/guideline.html. Centers for Medicare & Medicaid "Meaningful Measures Framework" resource available at https://www .cms.gov/Medicare/Quality-Initiatives-Patient-AssessmentInstruments/QualityInitiativesGeninfo/MMF/General-info-Sub-Page.html. 103 Hummel, J. Office of the National Coordinator for Health Information Technology (2013) "Integrating Clinical Decision Support Tools into Ambulatory Care Workflows for Improved Outcomes and Patient Safety" at https://www .healthit.gov/sites/default/files/clinical-decision-support-0913. pdf. 101 VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00459 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.276</GPH> amozie on DSK3GDR082PROD with RULES3 102 60294 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations fmal rule. According to the CDC, about 63,000 people died in 2016 of a drug overdose, and well over half of them are attributed to opioids. 104 Additionally, according to the 2016 National Survey on Drug Use and Health (NSDUH), 11.8 million individuals ages 12 and older misused any opioid (that is, prescription and/or illicit opioid) and 11.5 million individuals misused prescription opioids. Of those who misused opioids, 2.1 million individuals meet the criteria for an opioid use disorder. 105 Since providing education regarding the risks of concurrent opioid and benzodiazepine use directly helps to addresses the opioid epidemic, and use of CDS addresses CMS's policy focus on Promoting Interoperability, 106 we believe this improvement activity meets our considerations for Several commenters supported the inclusion of this improvement activity. A couple commenters provided general support for new improvement activities that address the opioid crisis. Two commenters noted that the CDC Guideline for Prescribing Opioids for Chronic Pain are "for primary care physicians prescribing opioids for chronic pain outside of active cancer treatment, palliative care, and end-of-life care," and that including this improvement activity may exacerbate a tendency for specialists to use the Guideline for patient populations for which it is not intended. Clinicians may meet this improvement activity by appropriately adhering to the CDC Guideline for Prescribing Opioids for Chronic Care and should pick activities to their clinical · and · Comments: Response: for Chronic Pain via Clinical In order to receive credit for this activity, MIPS eligible clinicians must utilize the Centers for Disease Control (CDC) Guideline for Prescribing Opioids for Chronic Pain 107 via clinical decision support (CDS). For CDS to be most effective, it needs to be built directly into the clinician workflow and support decision making on a specific patient at the point of care. Specific examples of how the guideline could be incorporated into a CDS workflow include, but are not limited to: electronic health record (EHR)-based prescribing prompts, order sets that require review of guidelines before prescriptions can be entered, and prompts requiring review of guidelines before a subsequent action can be taken in the record. 104 Hedegaard, H., Warner, M., & Minifio, A.M. (2017). NCHS Data BriefNo. 294. Center for Disease Control and Prevention National Center for Health Statistics. Available at https ://www .cdc.gov/nchs/products/databriefs/db294 .htm. 105 Park-Lee, E., Lipari, R.N., Hedden, S. L., Kroutil, L.A., & Porter, J.D. (2017). Receipt of Services for Substance Use and Mental Health Issues among Adults: Results from the 2016 National Survey on Drug Use and Health. Substance Abuse and Mental Health Services Administration NSDUH Data Review. Available at https://www.samhsa.gov/data!sites/default/files/NSDUH-DR-FFR2-2016/NSDUH-DR-FFR2-2016.htm. 106 Centers for Medicare & Medicaid Services "Promoting Interoperability (PI)" resource available at https ://www .cms.gov/RegulationsandGuidance!Legislation!EHRincentivePrograms/?redirect=/ehrincentiveprograms/. 107 CDC Prescribing Guidelines resource at https://www.cdc.gov/drugoverdose/prescribing/guideline.html. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00460 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.277</GPH> amozie on DSK3GDR082PROD with RULES3 Activity Description: Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60295 TABLE B: Changes to Previously Adopted Improvement Activities for the MIPS CY 2019 Performance Period and Future Years Proposed Changes and Rationale: Proposed Revised Activity Description: Comments: Improvement Activities Data Validation Criteria at https://www.cms.gov/Medicare/Quality-PaymentProgram!Resource-Library/20 18-Resources.html. 108 VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00461 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.278</GPH> amozie on DSK3GDR082PROD with RULES3 Response: Addition of" ... real time communication between PCP and consulting clinicians; PCP included on specialist follow-up or transition communications" as additional examples of how a patient-centered action plan could be documented. Primary care physicians are considered the gatekeeper of patient care. Including them in communications from specialists to patients about their follow-up of transition-of-care promotes continuity between clinicians. Adding this example to this improvement activity underscores the important role specialists play in care transition documentation practice improvement. Other was revised for In order to receive credit for this activity, a MIPS eligible clinician must document practices/processes for care transition with documentation of how a MIPS eligible clinician or group carried out an action plan for the patient with the patient's preferences in mind (that is, a "patient-centered" plan) during the first 30 days following a discharge. Examples of these practices/processes for care transition include: staff involved in the care transition; phone calls conducted in support of transition; accompaniments of patients to appointments or other navigation actions; home visits; patient information access to their medical records; real time communication between PCP and consulting clinicians; PCP included on specialist or transition communications. One commenter supported the proposed modification to this improvement activity. One commenter stated that the addition of specialty-specific examples in the modified improvement activities will provide clarity for specialty clinicians. One commenter provided general concern that modifYing an activity while it is still new makes it difficult for clinicians to become familiar with and implement activities. Another commenter requested we modifY the activity description to explicitly state that this improvement activity applies to care transitions from acute care and rehabilitation facilities following a fracture, and includes follow-up care related to promoting · and other related activities. The proposed modifications to this activity provide examples for further clarification of the role specialists play in care transition documentation practice improvement. Therefore, we do not believe this modification makes it more difficult for clinicians to become familiar with and implement the activity. Additionally, we disagree that we should modifY the activity description to explicitly state that this improvement activity applies to certain care transitions, for example those from acute care and rehabilitation facilities, because, we would like to keep the activity description broad. We believe specifYing certain care settings without including all others may lead some clinicians to believe they are not eligible to attest to this improvement activity. We will add fracture-related care to subregulatory guidance available on the Quality Payment Program website 108 so clinicians attesting to this activity are aware this is an allowable service to meet this im1nrnovP1m 60296 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations In order to receive credit for this activity, a MIPS eligible clinician must document practices/processes for care transition with documentation of how a MIPS eligible clinician or group carried out an action plan for the patient with the patient's preferences in mind (that is, a "patient-centered" plan) during the first 30 days following a discharge. Examples of these practices/processes for care transition include: staff involved in the care transition; phone calls conducted in support of transition; accompaniments of patients to appointments or other navigation actions; home visits; patient information access to their medical records; real time communication between PCP and consulting clinicians; PCP included on specialist or transition communications. Proposed Change and Rationale: Comments: amozie on DSK3GDR082PROD with RULES3 Response: VerDate Sep<11>2014 19:26 Nov 21, 2018 We proposed to remove PM_9, because we believe lA_PM_9 and lA_PM_17 are duplicative and provide improvement activity credit for the same activity. In the CY 2017 Quality Payment Program fmal rule (81 FR 77820), we fmalized IA_PM_9: Participation in Population Health Research (activity title); Participation in research that identifies interventions, tools or processes that can improve a targeted patient population (activity description). In the CY 2018 Quality Payment Program fmal rule (82 FR 54481), we fmalized IA_PM_17: Participation in Population Health Research (activity title); participation in federally and/or privately funded research that identifies interventions tools, or processes that can improve a targeted patient population (activity description). We believe IA_PM_9 and IA_PM_17 are duplicative because they include the same subcategory and activity title, and nearly an identical description of the activity; participation in "research that identifies interventions, tools, or processes that can improve a targeted patient population." The two activities are only distinguished by the inclusion in the description for lA_PM_17 specifying that clinicians can meet this activity through participation in federally and/or privately funded research that lA_PM_9 does not. Therefore, we proposed to remove IA_PM_9 and preserve IA_PM_17 so that we will have a consolidated that both activities. Several commenters supported the removal of this improvement activity, due to it being duplicative to lA_PM_17 with the only difference being lA_PM_17 stating that this activity can be met through participation in federally and/or privately funded research. One commenter expressed concern that removing an improvement activity while it is still new makes it difficult for clinicians to become familiar with and implement improvement activities. An additional commenter recommended that if an improvement activity is removed from the Inventory it should be replaced by another · to clinicians who could attest to the removed one. We believe that while consistency in available improvement activities is important, it is confusing to have nearly identical activities that clinicians can attest to. Since these improvement activities are duplicative, a clinician may report lA_PM_17 in the place of IA_PM_9. We do not believe this change will make it more difficult for clinicians to become familiar with or implement improvement activities. Additionally, we do not believe it is to add a new one that is · Jkt 247001 PO 00000 Frm 00462 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.279</GPH> Activity Description: Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60297 removed. We refer readers to section III.I.3.h.(d)(i) of this fmal rule where we discuss our criteria for nominating new improvement activities. We also clarified that we use the criteria for nominating new improvement activities in selecting improvement activities for inclusion in the program. Stakeholders can propose new activities through our Annual Call for Activities. After consideration of the public comments received, we are fmalizing the removal of this 1"n!"11'"\1"•"HTPtrl Proposed Change and Rationale: amozie on DSK3GDR082PROD with RULES3 Proposed Revised VerDate Sep<11>2014 19:26 Nov 21, 2018 Addition of examples of evidence based, condition-specific pathways for care of chronic conditions: "These might include, but are not limited to, the NCQA Diabetes Recognition Program (DRP) and the NCQA Heart/Stroke Recognition Program (HSRP)." These examples relating to diabetes, heart, and stroke pathways are examples of evidence based, condition-specific pathways for care of chronic conditions. These additions to this activity provide specialist-specific examples of actions that can be taken to meet the intent of this activity. We have received stakeholder feedback that additional specialty-specific activities would be welcome in the · activities · Other was revised for Chronic Care and Preventative Care Management for Empaneled Patients In order to receive credit for this activity, a MIPS eligible clinician must manage chronic and preventive care for empaneled patients (that is, patients assigned to care teams for the purpose of population health management), which could include one or more of the following actions: • Provide patients armually with an opportunity for development and/or adjustment of an individualized plan of care as appropriate to age and health status, including health risk appraisal; gender, age and condition-specific preventive care services; and plan of care for chronic conditions; • Use evidence for care of chronic conditions Jkt 247001 PO 00000 Frm 00463 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.280</GPH> Current Activity Description: Proactively manage chronic and preventive care for empaneled patients that could include one or more of the following: • Provide patients armually with an opportunity for development and/or adjustment of an individualized plan of care as appropriate to age and health status, including health risk appraisal; gender, age and condition-specific preventive care services; and plan of care for chronic conditions; • Use condition-specific pathways for care of chronic conditions (for example, hypertension, diabetes, depression, asthma and heart failure) with evidence-based protocols to guide treatment to target; such as a CDC-recognized diabetes prevention program; • Use pre-visit planning to optimize preventive care and team management of patients with chronic conditions; • Use panel support tools (registry functionality) to identify services due; • Use predictive analytical models to predict risk, onset and progression of chronic diseases; or • Use reminders and outreach (for example, phone calls, emails, postcards, patient portals and community health workers where available) to alert and educate patients about services and/or routine medication reconciliation. 60298 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations Comments: Response: example, hypertension, diabetes, depression, asthma, and heart failure). These might include, but are not limited to, the NCQA Diabetes Recognition Program (DRP) 109 and the NCQA Heart/Stroke Recognition Program (HSRP). 110 • Use pre-visit planning, that is, preparations for conversations or actions to propose with patient before an in-office visit to optimize preventive care and team management of patients with chronic conditions; • Use panel support tools, (that is, registry functionality) or other technology that can use clinical data to identify trends or data points in patient records to identify services due; • Use predictive analytical models to predict risk, onset and progression of chronic diseases; and/or • Use reminders and outreach (for example, phone calls, emails, postcards, patient portals, and community health workers where available) to alert and educate patients about services and/or routine medication reconciliation. Several commenters supported the proposed modifications to this improvement activity. One commenter stated that the addition of specialty-specific examples in the modified improvement activities will provide clarity for specialty clinicians. Another commenter recommended additional diabetes-related services, Diabetes Self Management Education and Support (DSME/S) services and Medical Nutrition Therapy (MNT), be included in the description as examples of appropriate services to be included in an individualized plan of care for patients with diabetes. One commenter provided general concern that modifying an activity while it is still new makes it difficult for clinicians to become familiar with and activities. The proposed modifications to this activity provide additional examples specialists may take to meet this activity. Therefore, we do not believe this modification makes it more difficult for clinicians to become familiar with and implement the activity. Additional diabetes-related services may be eligible for this improvement activity if they are part of a clinician's management of chronic and preventive care for empaneled patients. It is important to note that the examples provided in the description of the improvement activity are not all inclusive and do not preclude clinicians from providing other services to meet this improvement activity. We want this activity to be applicable to all MIPS eligible clinicians providing chronic care and preventative care management to empaneled patients, and since we cannot include all possible activities that could meet this improvement activity and one diabetes-related example is already included, we do not believe adding additional diabetes-related examples to the activity description assists in making the improvement activity applicable to a wide array of clinicians. Upon review of the evidence for DSME/S services and MNT, those examples will be added to the subregulatory guidance available on the Quality Payment Program website 111 for the'""."'""'""'"' After consideration of the public comments received, we are fmalizing our changes to this '""'"'""""'"""'nt In order to receive credit for this activity, a MIPS eligible clinician must manage chronic and preventive care for empaneled patients (that is, patients assigned to care teams for the · health which could include one or 109 Diabetes Recognition Program information at https://www.ncqa.org/programs/recognition/clinicians/diabetesrecognition-program-drp. 110 NCQA Heart/Stroke Recognition Program information at https://www.ncqa.org/programs/recognition/clinicians!heart-stroke-recognition-program-hsrp. 111 Improvement Activity Data Validation Criteria at https://www.cms.gov/Medicare/Quality-PaymentProgram/Resource-Library/20 18-Resources.html. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00464 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.281</GPH> amozie on DSK3GDR082PROD with RULES3 Activity Description: Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60299 Current Activity Description: Participation in Maintenance of Certification (MOC) Part IV, such as the American Board of Internal Medicine (ABIM) Approved Quality Improvement (AQI) Program, National Cardiovascular Data Registry (NCDR) Clinical Quality Coach, Quality Practice Initiative Certification Program, American Board of Medical Specialties Practice Performance Improvement Module or American Society of Anesthesiologists (ASA) Simulation Education Network, for improving professional practice including participation in a local, regional or national outcomes registry or quality assessment program. Performance of monthly activities across practice to regularly assess performance in practice, by reviewing outcomes addressing identified areas for •m,nrllMP1mP1nT and the results. Proposed Change and Rationale: Added two examples of ways in which a MIPS eligible clinician can participate in Maintenance of Certification (MOC) Part IV: participation in "specialty-specific activities including Safety Certification in Outpatient Practice Excellence (SCOPE);" u 4 and "American Psychiatric Association (APA) Performance in Practice modules."u 5 These additions to the activity provide specialist-specific examples of actions that can be taken to meet this activity. We have received stakeholder feedback through listening sessions and meetings with various stakeholder entities that additional specialty-specific activities would be welcome in the Inventory. Specifically, adding these examples of activities in and obstetrics and fill a in the uz Diabetes Recognition Program information at https://www.ncqa.org/programs/recognition/clinicians/diabetesrecognition-program-drp. 113 NCQA Heart/Stroke Recognition Program information at https://www.ncqa.org/programs/recognition/clinicians!heart-stroke-recognition-program-hsrp. u 4 Safety Certification in Outpatient Practice Excellence for Women's Health resource at https://psnet.ahrq.gov/resources/resource/24964/acog-scope-safety-certification-in-outpatient-practice-excellencefor-womens-health. us Certification and Licensure in Psychiatry, for ABMS Maintenance of Certification Part IV resource at https://www. psychiatry .org/psychiatrists/education/certification-and-licensure/moe-part-4. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00465 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.282</GPH> amozie on DSK3GDR082PROD with RULES3 more of the following actions: • Provide patients annually with an opportunity for development and/or adjustment of an individualized plan of care as appropriate to age and health status, including health risk appraisal; gender, age and condition-specific preventive care services; and plan of care for chronic conditions; • Use evidence based, condition-specific pathways for care of chronic conditions (for example, hypertension, diabetes, depression, asthma, and heart failure). These might include, but are not limited to, the NCQA Diabetes Recognition Program (DRP)u 2 and the NCQA Heart/Stroke Recognition Program (HSRP).u 3 • Use pre-visit planning, that is, preparations for conversations or actions to propose with patient before an in-office visit to optimize preventive care and team management of patients with chronic conditions; • Use panel support tools, (that is, registry functionality) or other technology that can use clinical data to identify trends or data points in patient records to identify services due; • Use predictive analytical models to predict risk, onset and progression of chronic diseases; and/or • Use reminders and outreach (for example, phone calls, emails, postcards, patient portals, and community health workers where available) to alert and educate patients about services due· and/or routine medication reconciliation. 60300 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations Inventory. Other language was revised for clarity. In order to receive credit for this activity, a MIPS eligible clinician must participate in Maintenance of Certification (MOC) Part IV. 116 MOC Part IV requires clinicians to perform monthly activities across practice to regularly assess performance by reviewing outcomes addressing identified areas for improvement and evaluating the results. Proposed Revised Activity Description: Comments: Response: Some examples of activities that can be completed to receive MOC Part IV credit are: the American Board oflntemal Medicine (ABIM) Approved Quality Improvement (AQI) Program, 117 National Cardiovascular Data Registry (NCDR) Clinical Quality Coach, 118 Quality Practice Initiative Certification Program, 119 American Board of Medical Specialties Practice Performance Improvement Module 120 or American Society of Anesthesiologists (ASA) Simulation Education Network, 121 for improving professional practice including participation in a local, regional or national outcomes registry or quality assessment program; specialty-specific activities including Safety Certification in Outpatient Practice Excellence (SCOPE); 122 American Psychiatric Association (APA) Performance in Practice modules. 123 One commenter supported the proposed modifications to this improvement activity. Another commenter stated that the addition of specialty-specific examples in the modified improvement activities will provide clarity for specialty clinicians. A few commenters supported the addition of the specialist examples for this improvement activity, and one commenter provided general concern that modifying an activity while it is still new makes it difficult for clinicians to become familiar with and implement improvement activities. An additional commenter requested the inclusion of a reference to specific practice activities related to comprehensive pediatric eye and vision examination clinical practice guidelines to meet this improvement activity. The proposed modifications to this improvement activity provide additional examples of activities that can be completed to receive MOC Part IV credit. Therefore, we do not believe this modification makes it more difficult for clinicians to become familiar with and implement the activity. We appreciate the recommendation to include an additional example related to eye examinations, but we have included several examples and do not believe an additional example is needed in the activity description to describe the various ways clinicians can meet this improvement activity. We will add the American Board of Optometry's Performance in Practice activities, within which the comprehensive pediatric eye and vision examination clinical practice guidelines falls, to the subregulatory guidance available on the Quality Payment Program website 124 so American Board of Medical Specialties Maintenance of Certification Part IV resource at https://www .abms.orglboard-certification/steps-toward-initial-certification-and-moe/. 117 American Board of Internal Medicine Approved Quality Improvement Program resource at https://www .abim.org/reference-pages/approved-activities.aspx. 118 American College of Cardiology National Cardiovascular Data Registry Clinical Quality Coach Practice Dashboard resource at https://cvquality.acc.org/NCDR-Home/clinical-quality-coach!marketing. 119 American Society of Clinical Oncology Quality Oncology Practice Initiative Certification Program resource at https ://practice.asco. org/quality-improvement/quality-programs/qopi-certificationprogram. 120 American Board of Medical Specialties Multi-Specialty Portfolio Program resource at https://mocportfolioprogram.org/about-us/. 121 American Society of Anesthesiologists Simulation Education Network resource at https ://www .asahq .org/education/simulation-education. 122 American College of Obstetricians and Gynecologists Safety Certification in Outpatient Practice Excellence for Women's Health resource at https://www.acog.org/About-ACOG/ACOG-DepartmentsNRQC-andSCOPE/SCOPE-Program-Overview. 123 American Psychiatric Association Learning Center resource at https:/I education. psychiatry .org/Users/ProductList.aspx?TypeiD=8. 124 Improvement Activities Data Validation Criteria at https://www.cms.gov/Medicare/Quality-PaymentProgram!Resource-Library/20 18-Resources.html. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00466 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.283</GPH> amozie on DSK3GDR082PROD with RULES3 116 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations 60301 this activity are aware these are allowable services to meet this In order to receive credit for this activity, a MIPS eligible clinician must participate in Maintenance of Certification (MOC) Part IV. 125 MOC Part IV requires clinicians to perform monthly activities across practice to regularly assess performance by reviewing outcomes addressing identified areas for improvement and evaluating the results. Activity Description: Use of tools that assist specialty practices in tracking specific measures that are meaningful to their practice, such as use of a surgical risk calculator, evidence based protocols such as Enhanced Recovery After Surgery (ERAS) protocols, the CDC Guide for Infection Prevention for Outpatient Settings, (https://www.cdc.gov/hai/settings/outoatient/outoatient-care-guidelines.htrnl), or similar tools. 125 American Board ofMedical Specialties Maintenance of Certification Part IV resource at https://www .abms.org/board-certification/steps-toward-initial-certification-and-moe/. 126 American Board of Internal Medicine Approved Quality Improvement Program resource at https://www .abim.org/reference-pages/approved-activities.aspx. 127 American College of Cardiology National Cardiovascular Data Registry Clinical Quality Coach Practice Dashboard resource at https://cvquality.acc.org!NCDR-Home/clinical-quality-coach/marketing. 128 American Society of Clinical Oncology Quality Oncology Practice Initiative Certification Program resource at https ://practice.asco. org/quality-improvement/quality-programs/qopi-certificationprogram. 129 American Board of Medical Specialties Multi-Specialty Portfolio Program resource at https://mocportfolioprogram.org/about-us/. 130 American Society of Anesthesiologists Simulation Education Network resource at https://www .asahq .org/education/simulation-education. 131 American College of Obstetricians and Gynecologists Safety Certification in Outpatient Practice Excellence for Women's Health resource at https://www.acog.org/About-ACOG/ACOG-DepartmentsNRQC-andSCOPE/SCOPE-Program-Overview. 132 American Psychiatric Association Learning Center resource at https ://education. psychiatry .org!Users/ProductList.aspx?TypeiD=8. VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00467 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.284</GPH> amozie on DSK3GDR082PROD with RULES3 Current Activity Description: Some examples of activities that can be completed to receive MOC Part IV credit are: the American Board oflntemal Medicine (ABIM) Approved Quality Improvement (AQI) Program, 126 National Cardiovascular Data Registry (NCDR) Clinical Quality Coach, 127 Quality Practice Initiative Certification Program, 128 American Board of Medical Specialties Practice Performance Improvement Module 129 or American Society of Anesthesiologists (ASA) Simulation Education Network, 130 for improving professional practice including participation in a local, regional or national outcomes registry or quality assessment program; specialty-specific activities including Safety Certification in Outpatient Practice Excellence (SCOPE); 131 American Psychiatric Association Performance in Practice modules. 132 60302 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations Rationale: example/category of an action that can be undertaken to meet the requirements of this activity. This addition highlights an evidence-based tool that can be deployed to assess opiate risk and addresses the CMS Meaningful Measures area of Prevention and Treatment of Opioid and Substance Use Disorders. 133 Other language was revised for In order to receive credit for this activity, a MIPS eligible clinician must use tools that assist specialty practices in tracking specific measures that are meaningful to their practice. Proposed Revised Activity Description: Comments: Response: Activity Description: Some examples of tools that could satisfy this activity are: a surgical risk calculator; evidence based protocols, such as Enhanced Recovery After Surgery (ERAS) protocols; 134 the Centers for Disease Control (CDC) Guide for Infection Prevention for Outpatient Settings predictive algorithms; 135 and the opiate risk tool (ORT) 136 or similar tool. One commenter stated that the addition of specialty-specific examples in the modified improvement activities will provide clarity for specialty clinicians. A couple of commenters provided support for the addition of the opiate risk tool or other similar tools as a way of addressing the opioid crisis. One commenter provided general concern that modifying an activity while it is still new makes it difficult for clinicians to become familiar with and activities. The proposed modification to this improvement activity provides an additional tool as an example that can be undertaken to meet the requirements of this improvement activity. Therefore, we do not believe this modification makes it more difficult for clinicians to become familiar with and the In order to receive credit for this activity, a MIPS eligible clinician must use tools that assist specialty practices in tracking specific measures that are meaningful to their practice. Some examples of tools that could satisfy this activity are: a surgical risk calculator; evidence based protocols, such as Enhanced Recovery After Surgery (ERAS) protocols; 137 the Centers for Disease Control (CDC) Guide for Infection Prevention for Outpatient Settings predictive algorithms; 138 and the opiate risk tool or similar tool. 133 Centers for Medicare & Medicaid Services "Meaningful Measures Hub" resource at https://www .cms.gov/Medicare/Quality-Initiatives-Patient-AssessmentInstruments/QualityInitiativesGenlnfo/MMF/General-info-Sub-Page.html #MeasureAreasDefmed. 134 Enhanced Recovery After Surgery (ERAS) protocols at https://aserhq.org/protocols/. 135 The Centers for Disease Control (CDC) Guide for Infection Prevention for Outpatient Settings at https://www.cdc.gov/hailsettings/outpatient/outpatient-care-guidelines.html. 136 The Opiate Risk Tool at https://www.drugabuse.gov/sites/default/files/files/OpioidRiskTool.pdf. 137 Enhanced Recovery After Surgery (ERAS) protocols at https://aserhq.org/protocols/. 138 The Centers for Disease Control (CDC) Guide for Infection Prevention for Outpatient Settings at https://www.cdc.gov/hailsettings/outpatient/outpatient-care-guidelines.html. 139 The Opiate Risk Tool at https://www.drugabuse.gov/sites/default/files/files/OpioidRiskTool.pd£ VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00468 Fmt 4701 Sfmt 4725 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.285</GPH> amozie on DSK3GDR082PROD with RULES3 of analytic capabilities to manage total cost of care for practice Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Rules and Regulations Build the analytic capability required to manage total cost of care for the practice population that could include one or more of the following: • Train appropriate staff on interpretation of cost and utilization information; and/or • Use available data regularly to analyze opportunities to reduce cost through care. Current Activity Description: Proposed Change and Rationale: Proposed Revised Activity Description: Comments: Response: 60303 We added an example platform that uses available data to analyze opportunities to reduce cost through improved care: "An example of a platform with the necessary analytic capability is the American Society for Gastrointestinal (GI) Endoscopy's GI Operations Benchmarking Platform." 140 Based on stakeholder feedback, we proposed to add this example to clarify what type of a platform has the analytic capability to improve and manage total cost of care for the practice population described. Other was revised for In order to receive credit for this activity, a MIPS eligible clinician must conduct or build the capacity to conduct analytic activities to manage total cost of care for the practice population. Examples of these activities could include: • Train appropriate staff on interpretation of cost and utilization information; • Use available data regularly to analyze opportunities to reduce cost through improved care. An example of a platform with the necessary analytic capability to do this is the American Society for Gastrointestinal (GI) Endoscopy's GI Operations Platform. One commenter supported the modification of this improvement activity. Another commenter stated that the addition of specialty-specific examples in the modified improvement activities will provide clarity for specialty clinicians. One commenter provided general concern that modifying an improvement activity while it is still new makes it difficult for clinicians to become familiar with and implement improvement activities. One commenter suggested including Fracture Liaison Service (FLS) ,.....,,,...~,tnc as an of a model to fracture and risk. We appreciate the commenters' support and the additional suggested example to provide greater clarification for this improvement activity. The modifications to this activity provide an example to clarify the type of platform that has the analytic capability to improve and manage total cost of care for the practice population described. Therefore, we do not believe this modification makes it more difficult for clinicians to become familiar with and implement the activity. We do not believe the FLS program meets the requirements of this improvement activity, as we do not agree that it · cost of care. of analytic capabilities to manage total cost of care for practice American Society for Gastrointestinal Endoscopy GI Operations Benchmarking at https://www .asge.org!home/practice-support/gi-operations-benchmarking. 140 [FR Doc. 2018–24170 Filed 11–1–18; 4:15 pm] BILLING CODE 4120–01–C VerDate Sep<11>2014 19:26 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00469 Fmt 4701 Sfmt 9990 E:\FR\FM\23NOR3.SGM 23NOR3 ER23NO18.286</GPH> amozie on DSK3GDR082PROD with RULES3 Activity Description: In order to receive credit for this activity, a MIPS eligible clinician must conduct or build the capacity to conduct analytic activities to manage total cost of care for the practice population. Examples of these activities could include: • Train appropriate staff on interpretation of cost and utilization information; • Use available data regularly to analyze opportunities to reduce cost through improved care. An example of a platform with the necessary analytic capability to do this is the American Society for Gastrointestinal (GI) Endoscopy's GI Operations · Platform.

Agencies

[Federal Register Volume 83, Number 226 (Friday, November 23, 2018)]
[Rules and Regulations]
[Pages 59836-60303]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24170]

[[Page 59451]]

Vol. 83

Friday,

No. 226

November 23, 2018

Part II

Department of Health and Human Services

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Centers for Medicare & Medicaid Services

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42 CFR Parts 405, 410, 411, et al.

Medicare Program; Revisions to Payment Policies Under the Physician
Fee Schedule and Other Revisions to Part B for CY 2019; Medicare Shared
Savings Program Requirements; Quality Payment Program; Medicaid
Promoting Interoperability Program; Quality Payment Program--Extreme
and Uncontrollable Circumstance Policy for the 2019 MIPS Payment Year;
Provisions From the Medicare Shared Savings Program--Accountable Care
Organizations--Pathways to Success; and Expanding the Use of Telehealth
Services for the Treatment of Opioid Use Disorder Under the Substance
Use-Disorder Prevention That Promotes Opioid Recovery and Treatment
(SUPPORT) for Patients and Communities Act; Final Rules and Interim
Final Rule

Federal Register / Vol. 83 , No. 226 / Friday, November 23, 2018 /
Rules and Regulations

[[Page 59452]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 405, 410, 411, 414, 415, 425, and 495

[CMS-1693-F, CMS-1693-IFC, CMS-5522-F3, and CMS-1701-F]
RIN 0938-AT31, 0938-AT13, & 0938-AT45

Medicare Program; Revisions to Payment Policies Under the
Physician Fee Schedule and Other Revisions to Part B for CY 2019;
Medicare Shared Savings Program Requirements; Quality Payment Program;
Medicaid Promoting Interoperability Program; Quality Payment Program--
Extreme and Uncontrollable Circumstance Policy for the 2019 MIPS
Payment Year; Provisions From the Medicare Shared Savings Program--
Accountable Care Organizations--Pathways to Success; and Expanding the
Use of Telehealth Services for the Treatment of Opioid Use Disorder
Under the Substance Use-Disorder Prevention That Promotes Opioid
Recovery and Treatment (SUPPORT) for Patients and Communities Act

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Final rules and interim final rule.

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SUMMARY: This major final rule addresses changes to the Medicare
physician fee schedule (PFS) and other Medicare Part B payment policies
to ensure that our payment systems are updated to reflect changes in
medical practice and the relative value of services, as well as changes
in the statute. This final rule also finalizes policies included in the
interim final rule with comment period in ``Medicare Program; CY 2018
Updates to the Quality Payment Program; and Quality Payment Program:
Extreme and Uncontrollable Circumstance Policy for the Transition
Year'' that address the extreme and uncontrollable circumstances MIPS
eligible clinicians faced as a result of widespread catastrophic events
affecting a region or locale in CY 2017, such as Hurricanes Irma,
Harvey and Maria. In addition, this final rule addresses a subset of
the changes to the Medicare Shared Savings Program for Accountable Care
Organizations (ACOs) proposed in the August 2018 proposed rule
``Medicare Program; Medicare Shared Savings Program; Accountable Care
Organizations--Pathways to Success''. This final rule also addresses
certain other revisions designed to update program policies under the
Shared Savings Program.
The interim final rule implements amendments made by the SUPPORT
for Patients and Communities Act to the Medicare telehealth provisions
in the Social Security Act and regarding permissible telehealth
originating sites for purposes of treatment of a substance use disorder
or a co-occurring mental health disorder for telehealth services
furnished on or after July 1, 2019 to an individual with a substance
use disorder diagnosis.

DATES: Effective Dates: These regulations are effective on January 1,
2019, except for the following:
Revisions to Sec. Sec. 414.1415(b)(2) and (3), and
414.1420(b), (c)(2), and (3), which are effective January 1, 2020; and
Amendments to Part 425, which are effective on December
31, 2018.
Applicability Date: The following provisions related to Section
II.I. of this final rule, Evaluation and Management Services, are
applicable beginning January 1, 2021: Implementation of a blended
payment rate for E/M visits levels 2-4; Payment to adjust the base E/M
visit rate(s) upward to account for visit complexity associated with
non-procedural specialty care and primary care; Payment to adjust the
base visit rate(s) upward to account for the additional resource costs
when practitioners need to spend significantly more time with
particular patients; and Flexible documentation requirements related to
Medical Decision Making, Time or Current E/M visit documentation
framework. The amendment to the definition of ``low-volume criteria''
at Sec. 414.1305 is applicable at the start of the first Merit-based
Incentive Payment System (MIPS) determination period for CY 2018 MIPS
performance period.
Comment date: To be assured consideration, comments must be
received at one of the addresses provided below, no later than 5 p.m.
on December 31, 2018.

ADDRESSES: In commenting, please refer to file code CMS-1693-IFC.
Because of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
Comments, including mass comment submissions, must be submitted in
one of the following three ways (please choose only one of the ways
listed):
1. Electronically. You may submit electronic comments on this
regulation to https://www.regulations.gov. Follow the ``Submit a
comment'' instructions.
2. By regular mail. You may mail written comments to the following
address only: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-1693-IFC, P.O. Box 8010,
Baltimore, MD 21244-8016.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address only: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-1693-IFC, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT:
Jamie Hermansen, (410) 786-2064, for any physician payment issues
not identified below.
Lindsey Baldwin, (410) 786-1694, and Emily Yoder, (410) 786-1804,
for issues related to evaluation and management (E/M) payment,
communication technology-based services and telehealth services.
Lindsey Baldwin, (410) 786-1694, for issues related to sections
2001(a) and 2005 of the SUPPORT for Patients and Communities Act.
Kathy Bryant, (410) 786-3448, for issues related to global surgery
data collection.
Isadora Gil, (410) 786-4532, for issues related to payment rates
for nonexcepted items and services furnished by nonexcepted off-campus
provider-based departments of a hospital, and work relative value units
(RVUs).
Ann Marshall, (410) 786-3059, for issues related to E/M
documentation guidelines.
Geri Mondowney, (410) 786-1172, for issues related to potentially
misvalued services, geographic price cost indices (GPCIs), and
malpractice RVUs.
Donta Henson, (410) 786-1947, for issues related to geographic
price cost indices (GPCIs).
Tourette Jackson, (410) 786-4735, for issues related to malpractice
RVUs.
Patrick Sartini, (410) 786-9252, for issues related to radiologist
assistants.
Michael Soracoe, (410) 786-6312, for issues related to practice
expense, work RVUs, impacts, and conversion factor.
Pamela West, (410) 786-2302, for issues related to therapy
services.
Edmund Kasaitis, (410) 786-0477, for issues related to reduction of
wholesale acquisition cost (WAC)-based payment.
Marcie O'Reilly, (410) 786-9764, for issues related to the
Potential Model for Radiation Therapy.

[[Page 59453]]

Sarah Harding, (410) 786-4001, or Craig Dobyski, (410) 786-4584,
for issues related to aggregate reporting of applicable information for
clinical laboratory fee schedule.
Amy Gruber, (410) 786-1542, or Glenn McGuirk, (410) 786-5723, for
issues related to the ambulance fee schedule.
Corinne Axelrod, (410) 786-5620, for issues related to care
management services and communication technology-based services in
Rural Health Clinics (RHCs) and Federally Qualified Health Centers
(FQHCs).
JoAnna Baldwin, (410) 786-7205, or Sarah Fulton, (410) 786-2749,
for issues related to appropriate use criteria for advanced diagnostic
imaging services.
Fiona Larbi, (410) 786-7224, for issues related to the Medicare
Shared Savings Program (Shared Savings Program) Quality Measures.
Matthew Edgar, (410) 786-0698, for issues related to the physician
self-referral law.
Molly MacHarris, (410) 786-4461, for inquiries related to Merit-
based Incentive Payment System (MIPS).
Benjamin Chin, (410) 786-0679, for inquiries related to Alternative
Payment Models (APMs).
David Koppel, (303) 844-2883, or Elizabeth LeBreton (202) 615-3816
for issues related to the Medicaid Promoting Interoperability Program.
Elizabeth November, (410) 786-8084, for inquiries related to the
Medicare Shared Savings Program [Pathways to Success].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
II. Provisions of the Final Rule for PFS
A. Background
B. Determination of Practice Expense (PE) Relative Value Units
(RVUs)
C. Determination of Malpractice Relative Value Units (RVUs)
D. Modernizing Medicare Physician Payment by Recognizing
Communication Technology-Based Services and Interim Final Rule
Expanding the Use of Telehealth Services for the Treatment of Opioid
Use Disorder and Other Substance Use Disorders Under the Substance
Use-Disorder Prevention That Promotes Opioid Recovery and Treatment
(SUPPORT) for Patients and Communities Act
E. Potentially Misvalued Services Under the PFS
F. Radiologist Assistants
G. Payment Rates Under the Medicare PFS for Nonexcepted Items
and Services Furnished by Nonexcepted Off-Campus Provider-Based
Departments of a Hospital
H. Valuation of Specific Codes
I. Evaluation & Management (E/M) Visits
J. Teaching Physician Documentation Requirements for Evaluation
and Management Services
K. GPCI Comment Solicitation
L. Therapy Services
M. Part B Drugs: Application of an Add-On Percentage for Certain
Wholesale Acquisition Cost (WAC)-Based Payments
N. Potential Model for Radiation Therapy
III. Other Provisions of the Final Rule
A. Clinical Laboratory Fee Schedule
B. Changes to the Regulations Associated With the Ambulance Fee
Schedule
C. Payment for Care Management Services and Communication
Technology-Based Services in Rural Health Clinics (RHCs) and
Federally Qualified Health Centers (FQHCs)
D. Appropriate Use Criteria for Advanced Diagnostic Imaging
Services
E. Medicaid Promoting Interoperability Program Requirements for
Eligible Professionals
F. Medicare Shared Savings Program Quality Measures
G. Physician Self-Referral Law
H. Physician Self-Referral Law: Annual Update to the List of
CPT/HCPCS Codes
I. CY 2019 Updates to the Quality Payment Program (Includes the
Extreme and Uncontrollable Circumstances MIPS Eligible Clinicians
Faced as a Result of Widespread Catastrophic Events Affecting a
Region or Locale in CY 2017 IFC Policies)
IV. Requests for Information
V. Medicare Shared Savings Program; Accountable Care Organizations--
Pathways to Success
VI. Collection of Information Requirements
VII. Regulatory Impact Analysis
Regulations Text
Appendix 1: Finalized MIPS Quality Measures
Appendix 2: Improvement Activities

Addenda Available Only Through the Internet on the CMS Website

The PFS Addenda along with other supporting documents and tables
referenced in this final rule are available on the CMS website at
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. Click on the
link on the left side of the screen titled, ``PFS Federal Regulations
Notices'' for a chronological list of PFS Federal Register and other
related documents. For the CY 2019 PFS final rule, refer to item CMS-
1693-F. Readers with questions related to accessing any of the Addenda
or other supporting documents referenced in this final rule and posted
on the CMS website identified above should contact Jamie Hermansen at
(410) 786-2064.

CPT (Current Procedural Terminology) Copyright Notice

Throughout this final rule, we use CPT codes and descriptions to
refer to a variety of services. We note that CPT codes and descriptions
are copyright 2018 American Medical Association. All Rights Reserved.
CPT is a registered trademark of the American Medical Association
(AMA). Applicable Federal Acquisition Regulations (FAR) and Defense
Federal Acquisition Regulations (DFAR) apply.

I. Executive Summary

A. Purpose

This major final rule makes payment and policy changes under the
Medicare PFS and implements certain provisions of the Bipartisan Budget
Act of 2018 (Pub. L. 115-123, February 9, 2018) and the SUPPORT for
Patients and Communities Act (Pub. L. 115-271, October 24, 2018)
related to Medicare Part B payment, and except as specified otherwise,
applicable to services furnished in CY 2019. This final rule also
revises certain policies under the Medicare Shared Savings Program.
1. Summary of the Major Provisions
The statute requires us to establish payments under the PFS based
on national uniform relative value units (RVUs) that account for the
relative resources used in furnishing a service. The statute requires
that RVUs be established for three categories of resources: Work;
practice expense (PE); and malpractice (MP) expense. In addition, the
statute requires that we establish by regulation each year's payment
amounts for all physicians' services paid under the PFS, incorporating
geographic adjustments to reflect the variations in the costs of
furnishing services in different geographic areas. In this major final
rule, we establish RVUs for CY 2019 for the PFS, and other Medicare
Part B payment policies, to ensure that our payment systems are updated
to reflect changes in medical practice and the relative value of
services, as well as changes in the statute. This final rule includes
discussions regarding:
Potentially Misvalued Codes.
Communication Technology-Based Services.
Provisions Expanding Telehealth Services for the Treatment
of Opioid Use Disorder and Other Substance Use Disorders under the
SUPPORT Act.
Valuation of New, Revised, and Misvalued Codes.
Payment Rates under the PFS for Nonexcepted Items and
Services Furnished by Nonexcepted Off-Campus Provider-Based Departments
of a Hospital.
Evaluation & Management (E/M) Visits.

[[Page 59454]]

Therapy Services.
Part B Drugs: Application of an Add-on Percentage for
Certain Wholesale Acquisition Cost (WAC)-based Payments.
Potential Model for Radiation Therapy.
Clinical Laboratory Fee Schedule.
Ambulance Fee Schedule--Provisions in the Bipartisan
Budget Act of 2018.
Rural Health Clinics (RHCs) and Federally Qualified Health
Centers (FQHCs).
Appropriate Use Criteria for Advanced Diagnostic Imaging
Services.
Medicaid Promoting Interoperability Program Requirements
for Eligible Professionals.
Medicare Shared Savings Program Quality Measures.
Physician Self-Referral Law.
Physician Self-Referral Law: Annual Update to the List of
CPT/HCPCS Codes.
CY 2019 Updates to the Quality Payment Program (including
the extreme and uncontrollable circumstances MIPS eligible clinicians
faced as a result of widespread catastrophic events affecting a region
or locale in CY 2017).
Comments in response to the Request for Information on
Promoting Interoperability and Electronic Healthcare Information
Exchange through Possible Revisions to the CMS Patient Health and
Safety Requirements for Hospitals and Other Medicare- and Medicaid-
Participating Providers and Suppliers.
Comments in response to the Request for Information on
Price Transparency: Improving Beneficiary Access to Provider and
Supplier Charge Information.
This rule also finalizes certain provisions from the ``Medicare
Program; Medicare Shared Savings Program; Accountable Care
Organizations--Pathways to Success'' proposed rule that appeared in the
August 17, 2018 Federal Register (83 FR 41786). Under the Medicare
Shared Savings Program, providers of services and suppliers that
participate in an ACO continue to receive traditional Medicare fee-for-
service (FFS) payments under Parts A and B, but the ACO may be eligible
to receive a shared savings payment if it meets specified quality and
savings requirements. ACOs participating under a two-sided shared
savings and shared losses model of the program may also be responsible
for repaying shared losses if the Parts A and B FFS expenditures for
their assigned beneficiaries exceed the ACO's historical benchmark. The
revised policies for ACOs participating in the Medicare Shared Savings
Program will ensure continuity of program participation for ACOs whose
agreement periods expire on December 31, 2018 by allowing these ACOs
the opportunity to elect a voluntary 6-month extension of their current
agreement periods; supporting coordination of care across settings and
strengthening beneficiary engagement; providing relief for ACOs
impacted by extreme and uncontrollable circumstance in performance year
2018 and subsequent years; and promoting interoperable electronic
health record technology among ACO providers/suppliers. We plan to
address the remaining proposals from the August 2018 proposed rule (83
FR 41786) in a forthcoming second final rule.
2. Summary of Costs and Benefits
We have determined that this major final rule is economically
significant. For a detailed discussion of the economic impacts, see
section VII. of this final rule.

B. Determination of Practice Expense (PE) Relative Value Units (RVUs)

1. Overview
Practice expense (PE) is the portion of the resources used in
furnishing a service that reflects the general categories of physician
and practitioner expenses, such as office rent and personnel wages, but
excluding MP expenses, as specified in section 1848(c)(1)(B) of the
Act. As required by section 1848(c)(2)(C)(ii) of the Act, we use a
resource-based system for determining PE RVUs for each physicians'
service. We develop PE RVUs by considering the direct and indirect
practice resources involved in furnishing each service. Direct expense
categories include clinical labor, medical supplies, and medical
equipment. Indirect expenses include administrative labor, office
expense, and all other expenses. The sections that follow provide more
detailed information about the methodology for translating the
resources involved in furnishing each service into service-specific PE
RVUs. We refer readers to the CY 2010 PFS final rule with comment
period (74 FR 61743 through 61748) for a more detailed explanation of
the PE methodology.
2. Practice Expense Methodology
a. Direct Practice Expense
We determine the direct PE for a specific service by adding the
costs of the direct resources (that is, the clinical staff, medical
supplies, and medical equipment) typically involved with furnishing
that service. The costs of the resources are calculated using the
refined direct PE inputs assigned to each CPT code in our PE database,
which are generally based on our review of recommendations received
from the RUC and those provided in response to public comment periods.
For a detailed explanation of the direct PE methodology, including
examples, we refer readers to the Five-Year Review of Work Relative
Value Units under the PFS and Proposed Changes to the Practice Expense
Methodology CY 2007 PFS proposed notice (71 FR 37242) and the CY 2007
PFS final rule with comment period (71 FR 69629).
Comment: Several commenters requested that CMS include pharmacists
as active qualified health care providers for purposes of calculating
physician PE direct costs. The commenters stated that pharmacists need
to be included in the calculation of direct PE expenses as an element
of the clinical labor variable relating to physicians' services. The
commenter stated that pharmacists are key members of the healthcare
team supporting the advent of digital medicine and telehealth services
and suggested that pharmacists should be recognized as staff included
in practice expense inputs.
Response: The direct PE input database contains the service-level
costs in clinical labor based on the typical service furnished to
Medicare beneficiaries. When these resource costs are typically
incurred in furnishing services, we do not have any standing policies
that would prohibit the inclusion of the costs in the direct PE input
database used to develop PE RVUs for individual services, to the extent
that inclusion of such costs would not lead to duplicative payments.
Therefore, we welcome more detailed information regarding the typical
clinical labor costs involving pharmacists for particular PFS services.
We note, however, that in the case of many PFS services, especially
care management services, certain elements of the services could be
provided by clinicians other than the billing professionals, which
could include services provided by pharmacists. As such, we encourage
interested stakeholders to provide information through the RUC process
or directly to us by February 10th prior to annual rulemaking about the
inclusion of additional clinical labor costs for specific services
described by HCPCS codes for which payment is made under the PFS, as
opposed to clinical labor costs that may be typical only under certain
circumstances.

[[Page 59455]]

b. Indirect Practice Expense per Hour Data
We use survey data on indirect PEs incurred per hour worked, in
developing the indirect portion of the PE RVUs. Prior to CY 2010, we
primarily used the PE/HR by specialty that was obtained from the AMA's
SMS. The AMA administered a new survey in CY 2007 and CY 2008, the
Physician Practice Expense Information Survey (PPIS). The PPIS is a
multispecialty, nationally representative, PE survey of both physicians
and NPPs paid under the PFS using a survey instrument and methods
highly consistent with those used for the SMS and the supplemental
surveys. The PPIS gathered information from 3,656 respondents across 51
physician specialty and health care professional groups. We believe the
PPIS is the most comprehensive source of PE survey information
available. We used the PPIS data to update the PE/HR data for the CY
2010 PFS for almost all of the Medicare-recognized specialties that
participated in the survey.
When we began using the PPIS data in CY 2010, we did not change the
PE RVU methodology itself or the manner in which the PE/HR data are
used in that methodology. We only updated the PE/HR data based on the
new survey. Furthermore, as we explained in the CY 2010 PFS final rule
with comment period (74 FR 61751), because of the magnitude of payment
reductions for some specialties resulting from the use of the PPIS
data, we transitioned its use over a 4-year period from the previous PE
RVUs to the PE RVUs developed using the new PPIS data. As provided in
the CY 2010 PFS final rule with comment period (74 FR 61751), the
transition to the PPIS data was complete for CY 2013. Therefore, PE
RVUs from CY 2013 forward are developed based entirely on the PPIS
data, except as noted in this section.
Section 1848(c)(2)(H)(i) of the Act requires us to use the medical
oncology supplemental survey data submitted in 2003 for oncology drug
administration services. Therefore, the PE/HR for medical oncology,
hematology, and hematology/oncology reflects the continued use of these
supplemental survey data.
Supplemental survey data on independent labs from the College of
American Pathologists were implemented for payments beginning in CY
2005. Supplemental survey data from the National Coalition of Quality
Diagnostic Imaging Services (NCQDIS), representing independent
diagnostic testing facilities (IDTFs), were blended with supplementary
survey data from the American College of Radiology (ACR) and
implemented for payments beginning in CY 2007. Neither IDTFs, nor
independent labs, participated in the PPIS. Therefore, we continue to
use the PE/HR that was developed from their supplemental survey data.
Consistent with our past practice, the previous indirect PE/HR
values from the supplemental surveys for these specialties were updated
to CY 2006 using the Medicare Economic Index (MEI) to put them on a
comparable basis with the PPIS data.
We also do not use the PPIS data for reproductive endocrinology and
spine surgery since these specialties currently are not separately
recognized by Medicare, nor do we have a method to blend the PPIS data
with Medicare-recognized specialty data.
Previously, we established PE/HR values for various specialties
without SMS or supplemental survey data by crosswalking them to other
similar specialties to estimate a proxy PE/HR. For specialties that
were part of the PPIS for which we previously used a crosswalked PE/HR,
we instead used the PPIS-based PE/HR. We use crosswalks for specialties
that did not participate in the PPIS. These crosswalks have been
generally established through notice and comment rulemaking and are
available in the file called ``CY 2019 PFS Final Rule PE/HR'' on the
CMS website under downloads for the CY 2019 PFS final rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
Comment: Several commenters recommended that it was time to
consider a new nationwide all specialty PE/HR survey, given the amount
of time that has passed since the last survey was conducted. The
commenters stated that the practice of medicine has significantly and
substantially evolved in the past decade and that many specialties have
had extensive changes in physician employment models during that time.
The commenters stated that continued use of the outdated PPIS survey
leads to an inappropriate and inaccurate distortion of the PE RVUs for
current practice.
Response: We have previously identified several concerns regarding
the underlying data used in determining PE RVUs in the CY 2014 PFS
final rule with comment period (78 FR 74246 through 74247). While we
continue to believe that the PPIS survey data are the best data
currently available, we continue to seek the best broad based,
auditable, routinely updated source of information regarding PE costs.
To that end, we have engaged a contractor, the RAND Corporation, to
explore the feasibility of updating the data used in the development of
PE RVUs.
Comment: One commenter requested that CMS consider studying
indirect PE associated with emergency departments including Emergency
Medical Treatment & Labor Act (EMTALA)-mandated uncompensated care. The
commenter stated that emergency physicians are not able to schedule
their patients and therefore cannot maximize the use of staff and
resources, and that there are costs associated with being open and
having to pay shift differentials over nights, weekends, and holidays.
Response: We will take the information under consideration for
future rulemaking.
For CY 2019, we have incorporated the available utilization data
for two new specialties, each of which became a recognized Medicare
specialty during 2017. These specialties are Hospitalists and Advanced
Heart Failure and Transplant Cardiology. We proposed to use proxy PE/HR
values for these new specialties, as there are no PPIS data for these
specialties, by crosswalking the PE/HR as follows from specialties that
furnish similar services in the Medicare claims data:
Hospitalists from Emergency Medicine, and
Advanced Heart Failure and Transplant Cardiology from
Cardiology.
These updates are reflected in the ``CY 2019 PFS Final Rule PE/HR''
file available on the CMS website under the supporting data files for
the CY 2019 PFS final rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-
Notices.html.
The following is a summary of the public comments we received on
our proposal to use proxy PE/HR values for these two new specialties.
Comment: One commenter stated that they supported the CMS proposal
to crosswalk the Advanced Heart Failure and Transplant specialty to the
cardiology PPIS data.
Response: We appreciate the support from the commenter for our
proposal.
Comment: A few commenters wrote to detail their concerns with the
current PE/HR assigned to home PT/INR monitoring services. Commenters
stated that these services are provided by entities that are enrolled
in Medicare as independent testing facilities because there is no other
specialty category that currently describes these suppliers; however,
home PT/INR monitoring services are fundamentally different in nature.
Commenters stated that home PT/INR monitoring services tend to be

[[Page 59456]]

more therapeutic than diagnostic in nature, typically utilize different
staffing types, and have a different ratio of direct to indirect costs.
The commenters encouraged CMS to consider home PT/INR monitoring as a
distinct specialty from independent testing facilities and to survey
suppliers to determine accurate indirect cost factors for these
services, while using either the Pathology or All Physicians specialty
as a proxy for PE/HR in the meantime. One commenter suggested that CMS
should consider holding payments harmless for home PT/INR monitoring
services while additional analysis is completed.
Response: We welcome suggestions from interested parties regarding
new indirect PE surveys and the use of PE/HR proxies that could be
considered for future rulemaking. Interested parties may wish to submit
a physician specialty designation request per the instructions found in
Pub. 100-04, Medicare Claims Processing Manual, Chapter 26, Section
10.8 (available on the CMS website at https://www.cms.gov/Regulations-
and-Guidance/Guidance/Manuals/Downloads/clm104c26.pdf). This section of
the Medicare Claims Processing Manual includes the criteria that CMS
uses to evaluate physician specialty designation requests.
After consideration of the public comments, we are finalizing our
proposal to use proxy PE/HR values for Hospitalists and Advanced Heart
Failure and Transplant Cardiology as described above.
c. Allocation of PE to Services
To establish PE RVUs for specific services, it is necessary to
establish the direct and indirect PE associated with each service.
(1) Direct Costs
The relative relationship between the direct cost portions of the
PE RVUs for any two services is determined by the relative relationship
between the sum of the direct cost resources (that is, the clinical
staff, medical supplies, and medical equipment) typically involved with
furnishing each of the services. The costs of these resources are
calculated from the refined direct PE inputs in our PE database. For
example, if one service has a direct cost sum of $400 from our PE
database and another service has a direct cost sum of $200, the direct
portion of the PE RVUs of the first service would be twice as much as
the direct portion of the PE RVUs for the second service.
(2) Indirect Costs
We allocate the indirect costs at the code level on the basis of
the direct costs specifically associated with a code and the greater of
either the clinical labor costs or the work RVUs. We also incorporate
the survey data described earlier in the PE/HR discussion (see section
II.B.2.b of this final rule). The general approach to developing the
indirect portion of the PE RVUs is as follows:
For a given service, we use the direct portion of the PE
RVUs calculated as previously described and the average percentage that
direct costs represent of total costs (based on survey data) across the
specialties that furnish the service to determine an initial indirect
allocator. That is, the initial indirect allocator is calculated so
that the direct costs equal the average percentage of direct costs of
those specialties furnishing the service. For example, if the direct
portion of the PE RVUs for a given service is 2.00 and direct costs, on
average, represent 25 percent of total costs for the specialties that
furnish the service, the initial indirect allocator would be calculated
so that it equals 75 percent of the total PE RVUs. Thus, in this
example, the initial indirect allocator would equal 6.00, resulting in
a total PE RVU of 8.00 (2.00 is 25 percent of 8.00 and 6.00 is 75
percent of 8.00).
Next, we add the greater of the work RVUs or clinical
labor portion of the direct portion of the PE RVUs to this initial
indirect allocator. In our example, if this service had a work RVU of
4.00 and the clinical labor portion of the direct PE RVU was 1.50, we
would add 4.00 (since the 4.00 work RVUs are greater than the 1.50
clinical labor portion) to the initial indirect allocator of 6.00 to
get an indirect allocator of 10.00. In the absence of any further use
of the survey data, the relative relationship between the indirect cost
portions of the PE RVUs for any two services would be determined by the
relative relationship between these indirect cost allocators. For
example, if one service had an indirect cost allocator of 10.00 and
another service had an indirect cost allocator of 5.00, the indirect
portion of the PE RVUs of the first service would be twice as great as
the indirect portion of the PE RVUs for the second service.
Next, we incorporated the specialty-specific indirect PE/
HR data into the calculation. In our example, if, based on the survey
data, the average indirect cost of the specialties furnishing the first
service with an allocator of 10.00 was half of the average indirect
cost of the specialties furnishing the second service with an indirect
allocator of 5.00, the indirect portion of the PE RVUs of the first
service would be equal to that of the second service.
(3) Facility and Nonfacility Costs
For procedures that can be furnished in a physician's office, as
well as in a facility setting, where Medicare makes a separate payment
to the facility for its costs in furnishing a service, we establish two
PE RVUs: Facility and nonfacility. The methodology for calculating PE
RVUs is the same for both the facility and nonfacility RVUs, but is
applied independently to yield two separate PE RVUs. In calculating the
PE RVUs for services furnished in a facility, we do not include
resources that would generally not be provided by physicians when
furnishing the service. For this reason, the facility PE RVUs are
generally lower than the nonfacility PE RVUs.
Comment: One commenter stated that it was not clear why the PE
change would differ so greatly between the office and facility settings
for CPT code 37227 (Revascularization, endovascular, open or
percutaneous, femoral, popliteal artery(s), unilateral; with
transluminal stent placement(s) and atherectomy, includes angioplasty
within the same vessel, when performed). The commenter stated that the
facility PE RVU for this CPT code was proposed to decrease by 4.8
percent while the non-facility PE RVU was proposed to decrease by 10.6
percent, and the commenter could not understand how these payment rates
were determined.
Response: As detailed above, the methodology for calculating PE
RVUs is the same for both the facility and nonfacility RVUs, but is
applied independently to yield two separate PE RVUs. It is not unusual
for facility and nonfacility RVUs for a CPT code to change at different
rates from year to year, as the direct costs associated with the
facility and nonfacility settings are typically distinct from one
another. For a more detailed description of the PE RVU methodology, we
refer readers to the CY 2007 PFS final rule with comment period (71 FR
69630 through 69643) and the CY 2010 PFS final rule with comment period
(74 FR 61745 through 61746).
(4) Services With Technical Components and Professional Components
Diagnostic services are generally comprised of two components: A
professional component (PC); and a technical component (TC). The PC and
TC may be furnished independently or by different providers, or they
may be

[[Page 59457]]

furnished together as a global service. When services have separately
billable PC and TC components, the payment for the global service
equals the sum of the payment for the TC and PC. To achieve this, we
use a weighted average of the ratio of indirect to direct costs across
all the specialties that furnish the global service, TCs, and PCs; that
is, we apply the same weighted average indirect percentage factor to
allocate indirect expenses to the global service, PCs, and TCs for a
service. (The direct PE RVUs for the TC and PC sum to the global.)
(5) PE RVU Methodology
For a more detailed description of the PE RVU methodology, we refer
readers to the CY 2010 PFS final rule with comment period (74 FR 61745
through 61746). We also direct readers to the file called ``Calculation
of PE RVUs under Methodology for Selected Codes'' which is available on
our website under downloads for the CY 2019 PFS final rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. This file
contains a table that illustrates the calculation of PE RVUs as
described in this final rule for individual codes.
(a) Setup File
First, we create a setup file for the PE methodology. The setup
file contains the direct cost inputs, the utilization for each
procedure code at the specialty and facility/nonfacility place of
service level, and the specialty-specific PE/HR data calculated from
the surveys.
(b) Calculate the Direct Cost PE RVUs
Sum the costs of each direct input.
Step 1: Sum the direct costs of the inputs for each service.
Step 2: Calculate the aggregate pool of direct PE costs for the
current year. We set the aggregate pool of PE costs equal to the
product of the ratio of the current aggregate PE RVUs to current
aggregate work RVUs and the projected aggregate work RVUs.
Step 3: Calculate the aggregate pool of direct PE costs for use in
ratesetting. This is the product of the aggregate direct costs for all
services from Step 1 and the utilization data for that service.
Step 4: Using the results of Step 2 and Step 3, use the CF to
calculate a direct PE scaling adjustment to ensure that the aggregate
pool of direct PE costs calculated in Step 3 does not vary from the
aggregate pool of direct PE costs for the current year. Apply the
scaling adjustment to the direct costs for each service (as calculated
in Step 1).
Step 5: Convert the results of Step 4 to a RVU scale for each
service. To do this, divide the results of Step 4 by the CF. Note that
the actual value of the CF used in this calculation does not influence
the final direct cost PE RVUs as long as the same CF is used in Step 4
and Step 5. Different CFs would result in different direct PE scaling
adjustments, but this has no effect on the final direct cost PE RVUs
since changes in the CFs and changes in the associated direct scaling
adjustments offset one another.
(c) Create the Indirect Cost PE RVUs
Create indirect allocators.
Step 6: Based on the survey data, calculate direct and indirect PE
percentages for each physician specialty.
Step 7: Calculate direct and indirect PE percentages at the service
level by taking a weighted average of the results of Step 6 for the
specialties that furnish the service. Note that for services with TCs
and PCs, the direct and indirect percentages for a given service do not
vary by the PC, TC, and global service.
We generally use an average of the 3 most recent years of available
Medicare claims data to determine the specialty mix assigned to each
code. Codes with low Medicare service volume require special attention
since billing or enrollment irregularities for a given year can result
in significant changes in specialty mix assignment. We finalized a
policy in the CY 2018 PFS final rule (82 FR 52982 through 59283) to use
the most recent year of claims data to determine which codes are low
volume for the coming year (those that have fewer than 100 allowed
services in the Medicare claims data). For codes that fall into this
category, instead of assigning specialty mix based on the specialties
of the practitioners reporting the services in the claims data, we
instead use the expected specialty that we identify on a list developed
based on medical review and input from expert stakeholders. We display
this list of expected specialty assignments as part of the annual set
of data files we make available as part of notice and comment
rulemaking and consider recommendations from the RUC and other
stakeholders on changes to this list on an annual basis. Services for
which the specialty is automatically assigned based on previously
finalized policies under our established methodology (for example,
``always therapy'' services) are unaffected by the list of expected
specialty assignments. We also finalized in the CY 2018 PFS final rule
(82 FR 52982 through 59283) a policy to apply these service-level
overrides for both PE and MP, rather than one or the other category.
For CY 2019, we proposed to add 28 additional codes that we
identified as low volume services to the list of codes for which we
assign the expected specialty. Based on our own medical review and
input from the RUC and from specialty societies, we proposed to assign
the expected specialty for each code as indicated in Table 1. For each
of these codes, only the professional component (reported with the -26
modifier) is nationally priced. The global and technical components are
priced by the Medicare Administrative Contractors (MACs) which
establish RVUs and payment amounts for these services. The list of
codes that we proposed to add is displayed in Table 1.

Table 1--New Additions to Expected Specialty List for Low Volume Services
----------------------------------------------------------------------------------------------------------------
2017
CPT code Modifier Short descriptor Expected specialty utilization
----------------------------------------------------------------------------------------------------------------
70557.............. 26................. Mri brain w/o dye......... Diagnostic Radiology...... 126
70558.............. 26................. Mri brain w/dye........... Diagnostic Radiology...... 32
74235.............. 26................. Remove esophagus Gastroenterology.......... 10
obstruction.
74301.............. 26................. X-rays at surgery add-on.. Diagnostic Radiology...... 73
74355.............. 26................. X-ray guide intestinal Diagnostic Radiology...... 11
tube.
74445.............. 26................. X-ray exam of penis....... Urology................... 26
74742.............. 26................. X-ray fallopian tube...... Diagnostic Radiology...... 5
74775.............. 26................. X-ray exam of perineum.... Diagnostic Radiology...... 80
75801.............. 26................. Lymph vessel x-ray arm/leg Diagnostic Radiology...... 114
75803.............. 26................. Lymph vessel x-ray arms/ Diagnostic Radiology...... 41
leg.
75805.............. 26................. Lymph vessel x-ray trunk.. Diagnostic Radiology...... 50
75810.............. 26................. Vein x-ray spleen/liver... Diagnostic Radiology...... 46

[[Page 59458]]

76941.............. 26................. Echo guide for transfusion Obstetrics/Gynecology..... 15
76945.............. 26................. Echo guide villus sampling Obstetrics/Gynecology..... 31
76975.............. 26................. Gi endoscopic ultrasound.. Gastroenterology.......... 49
78282.............. 26................. Gi protein loss exam...... Diagnostic Radiology...... 8
79300.............. 26................. Nuclr rx interstit colloid Diagnostic Radiology...... 2
86327.............. 26................. Immunoelectrophoresis Pathology................. 24
assay.
87164.............. 26................. Dark field examination.... Pathology................. 30
88371.............. 26................. Protein western blot Pathology................. 2
tissue.
93532.............. 26................. R & l heart cath Cardiology................ 28
congenital.
93533.............. 26................. R & l heart cath Cardiology................ 36
congenital.
93561.............. 26................. Cardiac output measurement Cardiology................ 28
93562.............. 26................. Card output measure subsq. Cardiology................ 38
93616.............. 26................. Esophageal recording...... Cardiology................ 38
93624.............. 26................. Electrophysiologic study.. Cardiology................ 51
95966.............. 26................. Meg evoked single......... Neurology................. 72
95967.............. 26................. Meg evoked each addl...... Neurology................. 61
----------------------------------------------------------------------------------------------------------------

The complete list of expected specialty assignments for individual
low volume services, including the assignments for the codes identified
in Table 1, is available on our website under downloads for the CY 2019
PFS final rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
The following is a summary of the public comments we received on
our proposal to update the list of expected specialty assignments for
low volume services.
Comment: Several commenters supported the continued use of service-
level overrides for low volume codes, and stated that they agreed with
the addition of the proposed 28 codes to the list of expected
specialties.
Response: We appreciate the support from the commenters.
Comment: Several commenters stated that CPT code 22857 (Total disc
arthroplasty (artificial disc), anterior approach, including discectomy
to prepare interspace (other than for decompression), single
interspace, lumbar) was missing from the proposed list. These
commenters requested that CMS include CPT code 22857 in the low
utilization category and permanently assign it to the orthopaedic
surgery specialty to maintain payment stability and minimize annual
fluctuations.
Response: We agree with the commenters that CPT code 22857
qualifies as a low volume code, with an annual Medicare utilization of
roughly 20 services. We agree with the commenters that assigning this
code to the orthopaedic surgery specialty will help to maintain payment
stability, and we are finalizing the addition of CPT code 22857 to the
low volume services list.
Comment: One commenter stated that several of the proposed low
volume services would be more accurately assigned to different expected
specialties based on their practice patterns. The commenter stated that
CPT codes 70557 and 70558 are intraoperative exams and are most often
performed by neurosurgeons and that CPT code 74235 is a diagnostic
radiology code rather than a gastroenterology code. The commenter
stated that CPT code 75810 should be assigned to interventional
radiology rather than diagnostic radiology, and that CPT codes 78282
and 79300 should be assigned to nuclear medicine rather than diagnostic
radiology.
Response: We agree that these codes would be more accurately
assigned to the expected specialties described by the commenter based
on an examination of the claims data. We are finalizing changes in
expected specialty to these six codes as described by the commenter.
Comment: One commenter stated that there are four codes that are
still not included in the proposed CY 2019 low volume override list and
recommended that the following low volume procedures be added to the
override list with the indicated specialty assignment:
Cardiac Surgery: CPT code 35812, and
Thoracic Surgery: CPT codes 32654, 33025 and 33251
Response: We agree with the inclusion of CPT codes 32654 and 33251.
These are services with very low annual utilization, and we are
finalizing their addition to the low volume services list with the
expected specialty as described by the commenter. We note that CPT code
33251 is already on the low volume services list with an expected
specialty of Cardiac Surgery; we are finalizing a change to the
Thoracic Surgery specialty as requested by the commenter. We are not
finalizing the addition of CPT code 35812 to the list, as it does not
appear to be a current CPT code. We are also not finalizing the
addition of CPT code 33025 to the list, as the code had a utilization
of more than 5,000 services in the most recent year of claims data, and
this would not qualify as a low volume service under the criteria that
we have previously finalized through rulemaking.
Comment: One commenter stated that the appropriate low volume
overrides were not applied to a series of congenital/pediatric cardiac
surgery codes. The commenter stated that each of these operations can
only be performed by congenital heart surgeons classified as either
cardiac or thoracic surgeons, and that they believe the malpractice
RVUs had been improperly decreased as a result of the low volume
service overrides not being applied.
Response: Each of the CPT codes identified by the commenter was
already present on the low volume services list with an expected
specialty assignment of either Cardiac Surgery or Thoracic Surgery. The
shifts in malpractice RVUs identified by the commenter were a result of
proposed policies associated with E/M visits. We refer readers to
section II.I. of this final rule for additional details on these
policies.
After consideration of the public comments, we are finalizing the
addition of the proposed 28 codes to the low volume services list, with
the expected specialty as proposed except where modified in response to
comments. We are also finalizing the addition of CPT codes 32654 and
33251 to the list with an expected specialty of Thoracic Surgery as
detailed previously.

[[Page 59459]]

Step 8: Calculate the service level allocators for the indirect PEs
based on the percentages calculated in Step 7. The indirect PEs are
allocated based on the three components: The direct PE RVUs; the
clinical labor PE RVUs; and the work RVUs.
For most services the indirect allocator is: Indirect PE percentage
* (direct PE RVUs/direct percentage) + work RVUs.
There are two situations where this formula is modified:
If the service is a global service (that is, a service
with global, professional, and technical components), then the indirect
PE allocator is: Indirect percentage (direct PE RVUs/direct percentage)
+ clinical labor PE RVUs + work RVUs.
If the clinical labor PE RVUs exceed the work RVUs (and
the service is not a global service), then the indirect allocator is:
Indirect PE percentage (direct PE RVUs/direct percentage) + clinical
labor PE RVUs.
(Note: For global services, the indirect PE allocator is based on
both the work RVUs and the clinical labor PE RVUs. We do this to
recognize that, for the PC service, indirect PEs would be allocated
using the work RVUs, and for the TC service, indirect PEs would be
allocated using the direct PE RVUs and the clinical labor PE RVUs. This
also allows the global component RVUs to equal the sum of the PC and TC
RVUs.)
For presentation purposes, in the examples in the download file
called ``Calculation of PE RVUs under Methodology for Selected Codes'',
the formulas were divided into two parts for each service.
The first part does not vary by service and is the
indirect percentage (direct PE RVUs/direct percentage).
The second part is either the work RVU, clinical labor PE
RVU, or both depending on whether the service is a global service and
whether the clinical PE RVUs exceed the work RVUs (as described earlier
in this step).
Apply a scaling adjustment to the indirect allocators.
Step 9: Calculate the current aggregate pool of indirect PE RVUs by
multiplying the result of step 8 by the average indirect PE percentage
from the survey data.
Step 10: Calculate an aggregate pool of indirect PE RVUs for all
PFS services by adding the product of the indirect PE allocators for a
service from Step 8 and the utilization data for that service.
Step 11: Using the results of Step 9 and Step 10, calculate an
indirect PE adjustment so that the aggregate indirect allocation does
not exceed the available aggregate indirect PE RVUs and apply it to
indirect allocators calculated in Step 8.
Calculate the indirect practice cost index.
Step 12: Using the results of Step 11, calculate aggregate pools of
specialty-specific adjusted indirect PE allocators for all PFS services
for a specialty by adding the product of the adjusted indirect PE
allocator for each service and the utilization data for that service.
Step 13: Using the specialty-specific indirect PE/HR data,
calculate specialty-specific aggregate pools of indirect PE for all PFS
services for that specialty by adding the product of the indirect PE/HR
for the specialty, the work time for the service, and the specialty's
utilization for the service across all services furnished by the
specialty.
Step 14: Using the results of Step 12 and Step 13, calculate the
specialty-specific indirect PE scaling factors.
Step 15: Using the results of Step 14, calculate an indirect
practice cost index at the specialty level by dividing each specialty-
specific indirect scaling factor by the average indirect scaling factor
for the entire PFS.
Step 16: Calculate the indirect practice cost index at the service
level to ensure the capture of all indirect costs. Calculate a weighted
average of the practice cost index values for the specialties that
furnish the service. (Note: For services with TCs and PCs, we calculate
the indirect practice cost index across the global service, PCs, and
TCs. Under this method, the indirect practice cost index for a given
service (for example, echocardiogram) does not vary by the PC, TC, and
global service.)
Step 17: Apply the service level indirect practice cost index
calculated in Step 16 to the service level adjusted indirect allocators
calculated in Step 11 to get the indirect PE RVUs.
The following is a summary of the public comments we received on
the indirect practice cost indices.
Comment: Many commenters stated that they were opposed to the
proposed significant shifts in the indirect practice cost indices at
the specialty level. Commenters stated that the creation of a separate
PE/HR rate for the E/M visits resulted in large unintended effects on
specialties given the way that indirect PE is allocated, and that this
was inconsistent with CMS' intent to maintain stability in payment. One
commenter stated that the proposal to create a separate PE/HR rate for
the E/M visits was based on statistically unsound methodology, had
opaque analytics, and was not resource-based. Many commenters stated
that the effects of the proposed changes to the indirect practice cost
indices had not been sufficiently detailed in the proposed rule to
allow for proper feedback from commenters. Commenters expressed concern
that a reduction in payment due to shifts in the indirect PE allocation
could affect patient access to critical services, such as but not
limited to CPT codes 96360 (intravenous infusion, hydration; initial,
31 minutes to 1 hour), 96372 (therapeutic, prophylactic, or diagnostic
injection (specify substance or drug); subcutaneous or intramuscular),
96374 (therapeutic, prophylactic or diagnostic injection IV push,
single or initial substance/drug), 96375 (therapeutic, prophylactic or
diagnostic injection; each additional sequential IV push of a new
substance/drug), and HCPCS code G0416 (Surgical pathology, gross and
microscopic examinations, for prostate needle biopsy, any method). A
few commenters stated that the proposed indirect practice cost indices
ignored statutory requirements that payments under the PFS must be
resource based and failed to meet the transparency requirements of the
Protecting Access to Medicare Act of 2014 (PAMA). Commenters urged CMS
not to finalize the proposed changes to the indirect practice cost
indices.
Response: The proposed changes in the indirect practice cost
indices identified by the commenters were a result of proposed policies
associated with E/M visits, and specifically the proposal to establish
a separate specialty for E/M visits. We refer readers to section II.I.
of this final rule for additional discussion of these policies.
Comment: One commenter stated that the level of detail in the CY
2019 PFS proposed rule was insufficient to comment on several aspects
of the proposed changes in coding and payment related to office/
outpatient E/M visits, which was a departure from past rules. The
commenter specifically stated that there was insufficient information
to model how the proposed changes in the office/outpatient E/M visit
codes affected the indirect practice cost indices for all other
services. Similarly, the commenter suggested that not enough
information was provided to simulate the PFS ratesetting in a way that
would isolate the impact of the proposed multiple procedure payment
reduction (MPPR), in the proposed rates and associated estimates of
specialty-level impact. The commenter requested that CMS provide
additional technical information and files going forward to enable the
commenter to better model proposed and future policies.
Response: We agree with commenters regarding the importance of
transparency and the need for detailed

[[Page 59460]]

information about proposed policies so that public commenters can
provide a full and informed response. We also understand that there is
merit to providing as much information as possible that would allow for
complete reproduction of our proposed and final ratesetting
methodologies. We also understand that the proposals related to office/
outpatient E/M visits are of great importance to the medical community
and represent a significant portion of spending under the PFS. We do
not agree with the commenter that the level of detail provided in the
proposed rule, including the data provided as publicly available
download files, was insufficient for public comment due to the
extensive documentation associated with the E/M policy proposals, or
that it represented a departure from past practice. Over several years,
we have invested significant resources in improving the transparency of
the data we use in developing proposed and final PFS rates. We intend
to maintain a focus on increasing transparency, and believe the
commenters' concerns will help us understand the kind of information
that can be most helpful to stakeholders interested in the underlying
data sets. While we are not finalizing the MPPR element of the E/M
proposal, we appreciate the commenter's interest in the use of code-
level assumptions regarding proposed payment adjustments that are
reflected in the discounts in the setup file, as discussed in section
II.B.2.(5)(e) of this final rule.
(d) Calculate the Final PE RVUs
Step 18: Add the direct PE RVUs from Step 5 to the indirect PE RVUs
from Step 17 and apply the final PE budget neutrality (BN) adjustment.
The final PE BN adjustment is calculated by comparing the sum of steps
5 and 17 to the proposed aggregate work RVUs scaled by the ratio of
current aggregate PE and work RVUs. This adjustment ensures that all PE
RVUs in the PFS account for the fact that certain specialties are
excluded from the calculation of PE RVUs but included in maintaining
overall PFS budget neutrality. (See ``Specialties excluded from
ratesetting calculation'' later in this final rule.)
Step 19: Apply the phase-in of significant RVU reductions and its
associated adjustment. Section 1848(c)(7) of the Act specifies that for
services that are not new or revised codes, if the total RVUs for a
service for a year would otherwise be decreased by an estimated 20
percent or more as compared to the total RVUs for the previous year,
the applicable adjustments in work, PE, and MP RVUs shall be phased in
over a 2-year period. In implementing the phase-in, we consider a 19
percent reduction as the maximum 1-year reduction for any service not
described by a new or revised code. This approach limits the year one
reduction for the service to the maximum allowed amount (that is, 19
percent), and then phases in the remainder of the reduction. To comply
with section 1848(c)(7) of the Act, we adjust the PE RVUs to ensure
that the total RVUs for all services that are not new or revised codes
decrease by no more than 19 percent, and then apply a relativity
adjustment to ensure that the total pool of aggregate PE RVUs remains
relative to the pool of work and MP RVUs. For a more detailed
description of the methodology for the phase-in of significant RVU
changes, we refer readers to the CY 2016 PFS final rule with comment
period (80 FR 70927 through 70931).
Comment: We received many comments regarding the ongoing decrease
in the technical component of CPT code 76881 (Ultrasound, complete
joint (i.e., joint space and peri-articular soft tissue structures)
real-time with image documentation). Commenters stated that this
procedure is essential for making appropriate diagnosis and managing
patients with various rheumatologic conditions and musculoskeletal
disorders. Commenters stated that cutting the reimbursement for the
code would not only result in poor patient care but also increase total
costs through the use of more expensive MRI procedures. Commenters also
disagreed with the RUC's recommended direct PE inputs for CPT code
76881 from the CY 2018 rule cycle, citing concerns with the RUC's use
of workforce data, and urged CMS not to make further reductions in
payment.
Response: The comments regarding CPT code 76881 are out of scope,
as we did not make any proposals involving this code for CY 2019. The
reductions in payment described by the commenters for CPT code 76881
were finalized as part of the CY 2018 PFS final rule (82 FR 53058-
53059), and are continuing to be phased in over time as part of the
transition policy described above. For a more detailed description of
the methodology for the phase-in of significant RVU changes, we refer
readers to the CY 2016 PFS final rule with comment period (80 FR 70927
through 70931).
(e) Setup File Information
Specialties excluded from ratesetting calculation: For the
purposes of calculating the PE RVUs, we exclude certain specialties,
such as certain NPPs paid at a percentage of the PFS and low-volume
specialties, from the calculation. These specialties are included for
the purposes of calculating the BN adjustment. They are displayed in
Table 2.

Table 2--Specialties Excluded From Ratesetting Calculation
--------------------------------------------------------------------------------------------------------------------------------------------------------
Specialty code Specialty description
--------------------------------------------------------------------------------------------------------------------------------------------------------
49................................. Ambulatory surgical center.
50................................. Nurse practitioner.
51................................. Medical supply company with certified orthotist.
52................................. Medical supply company with certified prosthetist.
53................................. Medical supply company with certified prosthetist[dash]orthotist.
54................................. Medical supply company not included in 51, 52, or 53.
55................................. Individual certified orthotist.
56................................. Individual certified prosthetist.
57................................. Individual certified prosthetist[dash]orthotist.
58................................. Medical supply company with registered pharmacist.
59................................. Ambulance service supplier, e.g., private ambulance companies, funeral homes, etc.
60................................. Public health or welfare agencies.
61................................. Voluntary health or charitable agencies.
73................................. Mass immunization roster biller.
74................................. Radiation therapy centers.
87................................. All other suppliers (e.g., drug and department stores).
88................................. Unknown supplier/provider specialty.

[[Page 59461]]

89................................. Certified clinical nurse specialist.
96................................. Optician.
97................................. Physician assistant.
A0................................. Hospital.
A1................................. SNF.
A2................................. Intermediate care nursing facility.
A3................................. Nursing facility, other.
A4................................. HHA.
A5................................. Pharmacy.
A6................................. Medical supply company with respiratory therapist.
A7................................. Department store.
B2................................. Pedorthic personnel.
B3................................. Medical supply company with pedorthic personnel.
--------------------------------------------------------------------------------------------------------------------------------------------------------

Crosswalk certain low volume physician specialties:
Crosswalk the utilization of certain specialties with relatively low
PFS utilization to the associated specialties.
Physical therapy utilization: Crosswalk the utilization
associated with all physical therapy services to the specialty of
physical therapy.
Identify professional and technical services not
identified under the usual TC and 26 modifiers: Flag the services that
are PC and TC services but do not use TC and 26 modifiers (for example,
electrocardiograms). This flag associates the PC and TC with the
associated global code for use in creating the indirect PE RVUs. For
example, the professional service, CPT code 93010 (Electrocardiogram,
routine ECG with at least 12 leads; interpretation and report only), is
associated with the global service, CPT code 93000 (Electrocardiogram,
routine ECG with at least 12 leads; with interpretation and report).
Payment modifiers: Payment modifiers are accounted for in
the creation of the file consistent with current payment policy as
implemented in claims processing. For example, services billed with the
assistant at surgery modifier are paid 16 percent of the PFS amount for
that service; therefore, the utilization file is modified to only
account for 16 percent of any service that contains the assistant at
surgery modifier. Similarly, for those services to which volume
adjustments are made to account for the payment modifiers, time
adjustments are applied as well. For time adjustments to surgical
services, the intraoperative portion in the work time file is used;
where it is not present, the intraoperative percentage from the payment
files used by contractors to process Medicare claims is used instead.
Where neither is available, we use the payment adjustment ratio to
adjust the time accordingly. Table 3 details the manner in which the
modifiers are applied.

Table 3--Application of Payment Modifiers to Utilization Files
----------------------------------------------------------------------------------------------------------------
Modifier Description Volume adjustment Time adjustment
----------------------------------------------------------------------------------------------------------------
80, 81, 82...................... Assistant at Surgery... 16%......................... Intraoperative portion.
AS.............................. Assistant at Surgery-- 14% (85% * 16%)............. Intraoperative portion.
Physician Assistant.
50 or LT and RT................. Bilateral Surgery...... 150%........................ 150% of work time.
51.............................. Multiple Procedure..... 50%......................... Intraoperative portion.
52.............................. Reduced Services....... 50%......................... 50%.
53.............................. Discontinued Procedure. 50%......................... 50%.
54.............................. Intraoperative Care Preoperative + Preoperative +
only. Intraoperative Percentages Intraoperative
on the payment files used portion.
by Medicare contractors to
process Medicare claims.
55.............................. Postoperative Care only Postoperative Percentage on Postoperative portion.
the payment files used by
Medicare contractors to
process Medicare claims.
62.............................. Co-surgeons............ 62.5%....................... 50%.
66.............................. Team Surgeons.......... 33%......................... 33%.
----------------------------------------------------------------------------------------------------------------

We also make adjustments to volume and time that correspond to
other payment rules, including special multiple procedure endoscopy
rules and multiple procedure payment reductions (MPPRs). We note that
section 1848(c)(2)(B)(v) of the Act exempts certain reduced payments
for multiple imaging procedures and multiple therapy services from the
BN calculation under section 1848(c)(2)(B)(ii)(II) of the Act. These
MPPRs are not included in the development of the RVUs.
For anesthesia services, we do not apply adjustments to volume
since we use the average allowed charge when simulating RVUs;
therefore, the RVUs as calculated already reflect the payments as
adjusted by modifiers, and no volume adjustments are necessary.
However, a time adjustment of 33 percent is made only for medical
direction of two to four cases since that is the only situation where a
single practitioner is involved with multiple beneficiaries
concurrently, so that counting each service without regard to the
overlap with other services would overstate the amount of time spent by
the practitioner furnishing these services.
Work RVUs: The setup file contains the work RVUs from this
final rule.
(6) Equipment Cost per Minute
The equipment cost per minute is calculated as:

[[Page 59462]]

(1/(minutes per year * usage)) * price * ((interest rate/(1-(1/((1 +
interest rate) [supcaret] life of equipment)))) + maintenance)

Where:

minutes per year = maximum minutes per year if usage were continuous
(that is, usage = 1); generally 150,000 minutes.

usage = variable, see discussion in this final rule.
price = price of the particular piece of equipment.
life of equipment = useful life of the particular piece of
equipment.
maintenance = factor for maintenance; 0.05.
interest rate = variable, see discussion in this final rule.

Usage: We currently use an equipment utilization rate assumption of
50 percent for most equipment, with the exception of expensive
diagnostic imaging equipment, for which we use a 90 percent assumption
as required by section 1848(b)(4)(C) of the Act.
Stakeholders have often suggested that particular equipment items
are used less frequently than 50 percent of the time in the typical
setting and that CMS should reduce the equipment utilization rate based
on these recommendations. We appreciate and share stakeholders'
interest in using the most accurate assumption regarding the equipment
utilization rate for particular equipment items. However, we believe
that absent robust, objective, auditable data regarding the use of
particular items, the 50 percent assumption is the most appropriate
within the relative value system. We welcome the submission of data
that would support an alternative rate.
Comment: A few commenters stated that equipment time associated
with payment for diagnostic imaging services is not aligned with
practice. The commenters disagreed with the CMS statement that certain
highly technical equipment is less likely to be used during all of the
preservice or postservice tasks performed by clinical labor staff, and
stated that the CMS analysis of equipment time is not accurate based on
their experience with imaging centers. Commenters stated that there are
non-imaging functions that are required by CMS for payment, such as
documentation requirements and the need for enrollment in Medicare by
professionals, which add to their administrative burden and increase
costs yet are underrepresented in the PE methodology. Commenters stated
that they disagreed with how CMS defined room time as inconsistent with
how imaging centers actually function, and indicated a preference for
assigning equipment time based on the total technologist time.
Response: We disagree with the commenters regarding the equipment
time assigned to highly technical equipment. We continue to believe
that certain highly technical pieces of equipment and equipment rooms
are less likely to be used during all of the preservice or postservice
tasks performed by clinical labor staff on the day of the procedure and
are typically available for other patients even when one member of
clinical staff may be occupied with a preservice or postservice task
related to the procedure. For a more detailed description of this
topic, we refer readers to the CY 2015 PFS final rule with comment
period (79 FR 67639 through 67640).
Maintenance: This factor for maintenance was finalized in the CY
1998 PFS final rule with comment period (62 FR 33164). As we previously
stated in the CY 2016 final rule with comment period (80 FR 70897), we
do not believe the annual maintenance factor for all equipment is
precisely 5 percent, and we concur that the current rate likely
understates the true cost of maintaining some equipment. We also
believe it likely overstates the maintenance costs for other equipment.
When we solicited comments regarding sources of data containing
equipment maintenance rates, commenters were unable to identify an
auditable, robust data source that could be used by CMS on a wide
scale. We do not believe that voluntary submissions regarding the
maintenance costs of individual equipment items would be an appropriate
methodology for determining costs. As a result, in the absence of
publicly available datasets regarding equipment maintenance costs or
another systematic data collection methodology for determining a
different maintenance factor, we do not believe that we have sufficient
information at present to propose a variable maintenance factor for
equipment cost per minute pricing. We continue to investigate potential
avenues for determining equipment maintenance costs across a broad
range of equipment items.
Comment: A commenter stated that they continue to believe that
maintenance costs for imaging equipment are much higher than the
current 5 percent assumption. The commenter stated that they were
hopeful that the market-based research into equipment and supply
pricing would result in a broad range, systematic data collection
methodology that could be applied to collecting information on
equipment maintenance costs.
Response: As detailed above, we continue to believe that the
current 5 percent maintenance factor likely understates the true cost
of maintaining some equipment and overstates the maintenance costs for
other equipment. We continue at this time to lack publicly available
datasets regarding equipment maintenance costs or another systematic
data collection methodology for determining maintenance factor. With
regards to the market-based study, the StrategyGen contractors were
tasked with updating the commercial pricing of supplies and equipment,
and did not include an investigation of equipment maintenance rates as
part of their research.
Interest Rate: In the CY 2013 PFS final rule with comment period
(77 FR 68902), we updated the interest rates used in developing an
equipment cost per minute calculation (see 77 FR 68902 for a thorough
discussion of this issue). The interest rate was based on the Small
Business Administration (SBA) maximum interest rates for different
categories of loan size (equipment cost) and maturity (useful life). We
did not propose any changes to these interest rates for CY 2019. The
interest rates are listed in Table 4.

Table 4--SBA Maximum Interest Rates
------------------------------------------------------------------------
Useful
Price life Interest
(years) rate (%)
------------------------------------------------------------------------
<$25K............................................. <7 7.50
$25K to $50K...................................... <7 6.50
>$50K............................................. <7 5.50
<$25K............................................. 7+ 8.00
$25K to $50K...................................... 7+ 7.00
>$50K............................................. 7+ 6.00
------------------------------------------------------------------------

3. Changes to Direct PE Inputs for Specific Services
This section focuses on specific PE inputs. The direct PE inputs
are included in the CY 2019 direct PE input database, which is
available on the CMS website under downloads for the CY 2019 PFS final
rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
a. Standardization of Clinical Labor Tasks
As we noted in the CY 2015 PFS final rule with comment period (79
FR 67640-67641), we continue to make improvements to the direct PE
input database to provide the number of clinical labor minutes assigned
for each task for every code in the database

[[Page 59463]]

instead of only including the number of clinical labor minutes for the
preservice, service, and postservice periods for each code. In addition
to increasing the transparency of the information used to set PE RVUs,
this level of detail would allow us to compare clinical labor times for
activities associated with services across the PFS, which we believe is
important to maintaining the relativity of the direct PE inputs. This
information would facilitate the identification of the usual numbers of
minutes for clinical labor tasks and the identification of exceptions
to the usual values. It would also allow for greater transparency and
consistency in the assignment of equipment minutes based on clinical
labor times. Finally, we believe that the detailed information can be
useful in maintaining standard times for particular clinical labor
tasks that can be applied consistently to many codes as they are valued
over several years, similar in principle to the use of physician
preservice time packages. We believe that setting and maintaining such
standards would provide greater consistency among codes that share the
same clinical labor tasks and could improve relativity of values among
codes. For example, as medical practice and technologies change over
time, changes in the standards could be updated simultaneously for all
codes with the applicable clinical labor tasks, instead of waiting for
individual codes to be reviewed.
In the CY 2016 PFS final rule with comment period (80 FR 70901), we
solicited comments on the appropriate standard minutes for the clinical
labor tasks associated with services that use digital technology. After
consideration of comments received, we finalized standard times for
clinical labor tasks associated with digital imaging at 2 minutes for
``Availability of prior images confirmed'', 2 minutes for ``Patient
clinical information and questionnaire reviewed by technologist, order
from physician confirmed and exam protocoled by radiologist'', 2
minutes for ``Review examination with interpreting MD'', and 1 minute
for ``Exam documents scanned into PACS.'' Exam completed in RIS system
to generate billing process and to populate images into Radiologist
work queue.'' In the CY 2017 PFS final rule (81 FR 80184 through
80186), we finalized a policy to establish a range of appropriate
standard minutes for the clinical labor activity, ``Technologist QCs
images in PACS, checking for all images, reformats, and dose page.''
These standard minutes will be applied to new and revised codes that
make use of this clinical labor activity when they are reviewed by us
for valuation. We finalized a policy to establish 2 minutes as the
standard for the simple case, 3 minutes as the standard for the
intermediate case, 4 minutes as the standard for the complex case, and
5 minutes as the standard for the highly complex case. These values
were based upon a review of the existing minutes assigned for this
clinical labor activity; we determined that 2 minutes is the duration
for most services and a small number of codes with more complex forms
of digital imaging have higher values.
We also finalized standard times for clinical labor tasks
associated with pathology services in the CY 2016 PFS final rule with
comment period (80 FR 70902) at 4 minutes for ``Accession specimen/
prepare for examination'', 0.5 minutes for ``Assemble and deliver
slides with paperwork to pathologists'', 0.5 minutes for ``Assemble
other light microscopy slides, open nerve biopsy slides, and clinical
history, and present to pathologist to prepare clinical pathologic
interpretation'', 1 minute for ``Clean room/equipment following
procedure'', 1 minute for ``Dispose of remaining specimens, spent
chemicals/other consumables, and hazardous waste'', and 1 minute for
``Prepare, pack and transport specimens and records for in-house
storage and external storage (where applicable).'' We do not believe
these activities would be dependent on number of blocks or batch size,
and we believe that these values accurately reflect the typical time it
takes to perform these clinical labor tasks.
Historically, the RUC has submitted a ``PE worksheet'' that details
the recommended direct PE inputs for our use in developing PE RVUs. The
format of the PE worksheet has varied over time and among the medical
specialties developing the recommendations. These variations have made
it difficult for both the RUC's development and our review of code
values for individual codes. Beginning with its recommendations for CY
2019, the RUC has mandated the use of a new PE worksheet for purposes
of their recommendation development process that standardizes the
clinical labor tasks and assigns them a clinical labor activity code.
We believe the RUC's use of the new PE worksheet in developing and
submitting recommendations will help us to simplify and standardize the
hundreds of different clinical labor tasks currently listed in our
direct PE database. As we did for CY 2018, to facilitate rulemaking for
CY 2019, we are continuing to display two versions of the Labor Task
Detail public use file: one version with the old listing of clinical
labor tasks, and one with the same tasks cross-walked to the new
listing of clinical labor activity codes. These lists are available on
the CMS website under downloads for the CY 2019 PFS final rule at
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
In reviewing the RUC-recommended direct PE inputs for CY 2019, we
noticed that the 3 minutes of clinical labor time traditionally
assigned to the ``Prepare room, equipment and supplies'' (CA013)
clinical labor activity were split into 2 minutes for the ``Prepare
room, equipment and supplies'' activity and 1 minute for the ``Confirm
order, protocol exam'' (CA014) activity. These RUC-reviewed codes do
not currently have clinical labor time assigned for the ``Confirm
order, protocol exam'' clinical labor task, and we do not have any
reason to believe that the services being furnished by the clinical
staff have changed, only the way in which this clinical labor time has
been presented on the PE worksheets.
As a result, we proposed to maintain the 3 minutes of clinical
labor time for the ``Prepare room, equipment and supplies'' activity
and remove the clinical labor time for the ``Confirm order, protocol
exam'' activity wherever we observed this pattern in the RUC-
recommended direct PE inputs. If we had received RUC recommendations
for codes that currently include clinical labor time for the ``Confirm
order, protocol exam'' clinical labor task, we would have left the RUC-
recommended clinical labor times unchanged, but there were no such
codes reviewed for CY 2019. We note that there is no effect on the
total clinical labor direct costs in these situations, since the same 3
minutes of clinical labor time is still being used in the calculation
of PE RVUs.
The following is a summary of the public comments we received on
our proposal to maintain the 3 minutes of clinical labor time for the
``Prepare room, equipment and supplies'' activity and remove the
clinical labor time for the ``Confirm order, protocol exam'' activity
wherever we observed the aforementioned pattern in the RUC-recommended
direct PE inputs.
Comment: Several commenters supported CMS' proposal and requested
that these clinical labor refinements should be finalized wherever the
refinement had been proposed. These commenters noted that there was no
change in the total clinical labor direct costs in these situations and
urged CMS to finalize the proposal.

[[Page 59464]]

Response: We appreciate the support for the proposal from the
commenters.
Comment: Other commenters disagreed with the proposal. Commenters
stated that the standard clinical labor time for the CA013 ``Prepare
room, equipment and supplies'' activity has always been 2 minutes, and
that the occasional assignment of additional clinical labor time in
individual procedures has not changed this standard.
Response: We agree with the commenters that the standard clinical
labor time for the CA013 activity code is 2 minutes. We noted in the
proposed rule that 3 minutes has often traditionally been assigned for
this clinical labor activity, and our proposal was intended to reflect
this common practice pattern. In our table of direct PE refinements, we
listed many of these clinical labor refinements using the refinement
code ``L1: Refined time to standard for this clinical labor task.''
This was the incorrect refinement code to use in these situations, and
we acknowledge that this was a technical error. The direct PE
refinements would have more accurately employed the general refinement
code ``G1: See preamble text'' instead. We wish to clarify that
although we agree that the standard clinical labor time for the CA013
activity is 2 minutes, we continue to believe that 2 minutes would not
be typical for many of the codes currently under discussion.
Comment: Commenters explained that when the new version of the PE
worksheet introduced the activity codes for clinical labor, there was a
need to translate old clinical labor tasks into the new activity codes.
In the old version of the PE worksheet, there was a clinical labor task
named ``Patient clinical information and questionnaire reviewed by
technologist, order from physician confirmed and exam protocoled by
radiologist.'' Commenters stated that this clinical labor task was
split into two of the new clinical labor activity codes: CA007
(``Review patient clinical extant information and questionnaire'') in
the preservice period, and CA014 (``Confirm order, protocol exam'') in
the service period. Commenters stated that the same clinical labor from
the old PE worksheet is now divided into the CA007 and CA014 activity
codes, with a standard of 1 minute for each activity. The commenters
stated that they recognized that the proposal had no effect on the
total clinical labor direct costs, but urged CMS not to finalize anyway
due to concerns over inaccuracy and long term effects on the direct
practice expense inputs across the PFS.
Response: We agree with the commenters that in situations where a
CPT code under review had the old clinical labor task ``Patient
clinical information and questionnaire reviewed by technologist, order
from physician confirmed and exam protocoled by radiologist'' on a
prior version of the PE worksheet, and where that old clinical labor
task was divided into the new CA007 and CA014 activity codes as
described by the commenters, we will not finalize our proposed
refinements to maintain 3 minutes of clinical labor time for the
``Prepare room, equipment and supplies'' activity and remove the
clinical labor time for the ``Confirm order, protocol exam'' activity,
as we agree that the old clinical labor task is adequately accounted
for by being divided into the new activity codes. In these cases, we
will finalize the RUC-recommended 2 minutes of clinical labor time for
the CA007 activity code and 1 minute for the CA014 activity code.
However, when reviewing the clinical labor for the reviewed codes
affected by this issue, we found that several of the codes did not
include the old clinical labor task ``Patient clinical information and
questionnaire reviewed by technologist, order from physician confirmed
and exam protocoled by radiologist'' on a prior version of the PE
worksheet. We also noted that several of the reviewed codes that
contained the CA014 clinical labor activity code for ``Confirm order,
protocol exam'' did not contain any clinical labor for the CA007
activity (``Review patient clinical extant information and
questionnaire''). In these situations, we believe that it is more
accurate to finalize our direct PE refinements to maintain the 3
minutes of clinical labor time for the ``Prepare room, equipment and
supplies'' activity and remove the clinical labor time for the
``Confirm order, protocol exam'' activity as proposed, since the
rationale provided by the commenters does not appear to be the case.
These codes do not appear to be an instance where the old clinical
labor task was split into two new clinical labor activities. We do not
understand how time assigned to an old clinical labor task could be
divided between the CA007 and CA014 activity codes, as the commenters
suggested, in situations where the code under review does not contain
any clinical labor for the CA007 activity. We continue to believe that
in these cases the 3 total minutes of clinical staff time would be more
accurately described by the CA013 ``Prepare room, equipment and
supplies'' activity code, as these codes do not currently have clinical
labor time assigned for the CA014 ``Confirm order, protocol exam''
clinical labor activity.
After consideration of the public comments, we are finalizing our
proposal for the reviewed codes that did not include the old clinical
labor task described above and do not contain any clinical labor for
the CA007 clinical labor activity. We are therefore finalizing our
proposal for CPT codes 27369, 38792, 76870, 77012, 77021, 92273, and
92274. We are not finalizing our proposal for the reviewed codes where
we were able to determine that the old clinical labor task had been
divided into the CA007 and CA014 activity codes as described by the
commenters. We are therefore finalizing the RUC-recommended CA013 and
CA014 clinical labor for CPT codes 76978, 76981, and 76982.
b. Equipment Recommendations for Scope Systems
During our routine reviews of direct PE input recommendations, we
have regularly found unexplained inconsistencies involving the use of
scopes and the video systems associated with them. Some of the scopes
include video systems bundled into the equipment item, some of them
include scope accessories as part of their price, and some of them are
standalone scopes with no other equipment included. It is not always
clear which equipment items related to scopes fall into which of these
categories. We have also frequently found anomalies in the equipment
recommendations, with equipment items that consist of a scope and video
system bundle recommended, along with a separate scope video system.
Based on our review, the variations do not appear to be consistent with
the different code descriptions.
To promote appropriate relativity among the services and facilitate
the transparency of our review process, during the review of the
recommended direct PE inputs for the CY 2017 PFS proposed rule, we
developed a structure that separates the scope, the associated video
system, and any scope accessories that might be typical as distinct
equipment items for each code. Under this approach, we proposed
standalone prices for each scope, and separate prices for the video
systems and accessories that are used with scopes.
(1) Scope Equipment
Beginning in the CY 2017 proposed rule (81 FR 46176 through 46177),
we proposed standardizing refinements to the way scopes have been
defined in the direct PE input database. We believe that there are four
general types of scopes: Non-video scopes; flexible

[[Page 59465]]

scopes; semi-rigid scopes, and rigid scopes. Flexible scopes, semi-
rigid scopes, and rigid scopes would typically be paired with one of
the scope video systems, while the non-video scopes would not. The
flexible scopes can be further divided into diagnostic (or non-
channeled) and therapeutic (or channeled) scopes. We proposed to
identify for each anatomical application: (1) A rigid scope; (2) a
semi-rigid scope; (3) a non-video flexible scope; (4) a non-channeled
flexible video scope; and (5) a channeled flexible video scope. We
proposed to classify the existing scopes in our direct PE database
under this classification system, to improve the transparency of our
review process and improve appropriate relativity among the services.
We planned to propose input prices for these equipment items through
future rulemaking.
We proposed these changes only for the reviewed codes for CY 2017
that made use of scopes, along with updated prices for the equipment
items related to scopes utilized by these services. We did not propose
to apply these policies to codes with inputs reviewed prior to CY 2017.
We also solicited comment on this separate pricing structure for
scopes, scope video systems, and scope accessories, which we could
consider proposing to apply to other codes in future rulemaking. We did
not finalize price increases for a series of other scopes and scope
accessories, as the invoices submitted for these components indicated
that they are different forms of equipment with different product IDs
and different prices. We did not receive any data to indicate that the
equipment on the newly submitted invoices was more typical in its use
than the equipment that we were currently using for pricing.
We did not make further changes to existing scope equipment in CY
2017 to allow the RUC's PE Subcommittee the opportunity to provide
feedback. However, we believed there was some miscommunication on this
point, as the RUC's PE Subcommittee workgroup that was created to
address scope systems stated that no further action was required
following the finalization of our proposal. Therefore, we made further
proposals in CY 2018 (82 FR 33961 through 33962) to continue clarifying
scope equipment inputs, and sought comments regarding the new set of
scope proposals. We considered creating a single scope equipment code
for each of the five categories detailed in this rule: (1) A rigid
scope; (2) a semi-rigid scope; (3) a non-video flexible scope; (4) a
non-channeled flexible video scope; and (5) a channeled flexible video
scope. Under the current classification system, there are many
different scopes in each category depending on the medical specialty
furnishing the service and the part of the body affected. We stated our
belief that the variation between these scopes was not significant
enough to warrant maintaining these distinctions, and we believed that
creating and pricing a single scope equipment code for each category
would help provide additional clarity. We sought public comment on the
merits of this potential scope organization, as well as any pricing
information regarding these five new scope categories.
After considering the comments on the CY 2018 PFS proposed rule, we
did not finalize our proposal to create and price a single scope
equipment code for each of the five categories previously identified.
Instead, we supported the recommendation from the commenters to create
scope equipment codes on a per-specialty basis for six categories of
scopes as applicable, including the addition of a new sixth category of
multi-channeled flexible video scopes. Our goal is to create an
administratively simple scheme that will be easier to maintain and help
to reduce administrative burden. We look forward to receiving detailed
recommendations from expert stakeholders regarding the scope equipment
items that would be typically required for each scope category, as well
as the proper pricing for each scope.
(2) Scope Video System
We proposed in the CY 2017 PFS proposed rule (81 FR 46176 through
46177) to define the scope video system as including: (1) A monitor;
(2) a processor; (3) a form of digital capture; (4) a cart; and (5) a
printer. We believe that these equipment components represent the
typical case for a scope video system. Our model for this system was
the ``video system, endoscopy (processor, digital capture, monitor,
printer, cart)'' equipment item (ES031), which we proposed to re-price
as part of this separate pricing approach. We obtained current pricing
invoices for the endoscopy video system as part of our investigation of
these issues involving scopes, which we proposed to use for this re-
pricing. In response to comments, we finalized the addition of a
digital capture device to the endoscopy video system (ES031) in the CY
2017 PFS final rule (81 FR 80188). We finalized our proposal to price
the system at $33,391, based on component prices of $9,000 for the
processor, $18,346 for the digital capture device, $2,000 for the
monitor, $2,295 for the printer, and $1,750 for the cart. In the CY
2018 PFS final rule (82 FR 52991 through 52993), we outlined, but did
not finalize, a proposal to add an LED light source into the cost of
the scope video system (ES031), which would remove the need for a
separate light source in these procedures. We also described a proposal
to increase the price of the scope video system by $1,000 to cover the
expense of miscellaneous small equipment associated with the system
that falls below the threshold of individual equipment pricing as scope
accessories (such as cables, microphones, foot pedals, etc.). With the
addition of the LED light (equipment code EQ382 at a price of $1,915),
the updated total price of the scope video system would be set at
$36,306. We did not finalize this updated pricing to the scope video
system in CY 2018, and indicated our intention to address these changes
in CY 2019 to incorporate feedback from expert stakeholders.
(3) Scope Accessories
We understand that there may be other accessories associated with
the use of scopes. We finalized a proposal in the CY 2017 PFS final
rule (81 FR 80188) to separately price any scope accessories outside
the use of the scope video system, and individually evaluate their
inclusion or exclusion as direct PE inputs for particular codes as
usual under our current policy based on whether they are typically used
in furnishing the services described by the particular codes.
(4) Scope Proposals for CY 2019
We understand that the RUC has convened a Scope Equipment
Reorganization Workgroup that will be incorporating feedback from
expert stakeholders with the intention of making recommendations to us
on scope organization and scope pricing. Since the workgroup was not
convened in time to submit recommendations for the CY 2019 PFS
rulemaking cycle, we proposed to delay proposals for any further
changes to scope equipment until CY 2020 so that we can incorporate the
feedback from the aforementioned workgroup. However, we proposed to
update the price of the scope video system (ES031) from its current
price of $33,391 to a price of $36,306 to reflect the addition of the
LED light and miscellaneous small equipment associated with the system
that falls below the threshold of individual equipment pricing as scope
accessories, as we explained in detail in the CY 2018 PFS final rule
(82 FR 52992 through 52993). We also proposed to update the name of the
ES031

[[Page 59466]]

equipment item from ``video system, endoscopy (processor, digital
capture, monitor, printer, cart)'' to ``scope video system (monitor,
processor, digital capture, cart, printer, LED light)'' to reflect the
fact that the use of the ES031 scope video system is not limited to
endoscopy procedures.
The following is a summary of the public comments we received on
our proposals involving scopes and scope systems.
Comment: Several commenters supported the decision to delay
proposals for any further changes to scope equipment until CY 2020 in
order to incorporate the feedback from the RUC's Scope Equipment
Reorganization Workgroup. One commenter thanked CMS for adding a scope
category for multi-channeled flexible video scopes. A different
commenter supported the proposal to increase the price of the scope
video system (ES03l) from its current price of $33,391 to a price of
$36,306 and also supported the proposed update to the name of the ES03l
equipment item since the use of the scope video system is not limited
to endoscopy procedures.
Response: We appreciate the support for our proposals from the
commenters.
Comment: One commenter stated that they were concerned that the
proposed pricing for both the scope video system (ES03l) and the
stroboscopy system (ES065) are less than the true cost of the equipment
items, and therefore do not accurately reimburse physicians for their
direct overhead costs. The commenter stated that they had supplied more
recent invoices for these equipment items, which should be taken into
consideration for pricing, and reiterated their disagreement with the
CMS proposal from the previous calendar year to create single scope
equipment categories for all specialties, as scope equipment is not
always comparable across specialties. A different commenter supplied
invoices for several other scope equipment items and requested that CMS
update the prices for these equipment codes and that the new pricing
take effect for CY 2019.
Response: We continue to believe that any further changes to scope
equipment, including invoice submissions to update scope pricing,
should be delayed until CY 2020 so that we can incorporate the feedback
from the RUC's Scope Equipment Reorganization Workgroup.
After consideration of the public comments, we are finalizing our
scope proposals for CY 2019 without refinement.
c. Balloon Sinus Surgery Kit (SA106) Comment Solicitation
Several stakeholders contacted CMS with regard to the use of the
kit, sinus surgery, balloon (maxillary, frontal, or sphenoid) (SA106)
supply in CPT codes 31295 (Nasal/sinus endoscopy, surgical; with
dilation of maxillary sinus ostium (e.g., balloon dilation), transnasal
or via canine fossa), 31296 (Nasal/sinus endoscopy, surgical; with
dilation of frontal sinus ostium (e.g., balloon dilation)), and 31297
(Nasal/sinus endoscopy, surgical; with dilation of sphenoid sinus
ostium (e.g., balloon dilation)). The stakeholders stated that the
price of the SA106 supply (currently $2,599.86) had decreased
significantly since it was priced through rulemaking for CY 2011 (75 FR
73351 through 75532), and that the Medicare payment for these three CPT
codes using the supply no longer seemed to be in proportion to what the
kits cost. They also indicated that the same catheter could be used to
treat multiple sinuses rather than being a disposable one-time use
supply. The stakeholders stated that marketing firms and sales
representatives are advertising these CPT codes as a method for
generating additional profits due to the payment for the procedures
exceeding the resources typically needed to furnish the services, and
requested that CMS investigate the use of the SA106 supply in these
codes.
When CPT codes 31295 through 31297 were initially reviewed during
the CY 2011 and CY 2012 PFS rulemaking cycles (75 FR 73251, and 76 FR
73184 through 73186, respectively), we expressed our reservations about
the pricing and the typical quantity of this supply item used in
furnishing these services. The RUC recommended for the CY 2012
rulemaking cycle that CMS remove the balloon sinus surgery kit from
each of these codes and implement separately billable alpha-numeric
HCPCS codes to allow practitioners to be paid the cost of the
disposable kits per patient encounter instead of per CPT code. We
stated at the time, and we continue to believe, that this option
presents a series of potential problems that we have addressed
previously in the context of the broader challenges regarding our
ability to price high cost disposable supply items. (For a discussion
of this issue, we direct the reader to our discussion in the CY 2011
PFS final rule with comment period (75 FR 73251)). We stated at the
time that since the balloon sinus surgery kits can be used when
furnishing more than one service to the same beneficiary on the same
day, we believed that it would be appropriate to include 0.5 balloon
sinus surgery kits for each of the three codes, and we have maintained
this 0.5 supply quantity when CPT codes 31295-31297 were recently
reviewed again in CY 2018.
In light of the additional information supplied by the
stakeholders, we solicited comments on two aspects of the use of the
balloon sinus surgery kit (SA106) supply. First, we solicited comments
on whether the 0.5 supply quantity of the balloon sinus surgery kit in
CPT codes 31295-31297 would be typical for these procedures. We are
concerned that the same kit can be used when furnishing more than one
service to the same beneficiary on the same day, and that even the 0.5
supply quantity may be overstating the resources typically needed to
furnish each service. Second, we solicited comments on the pricing of
the balloon sinus surgery kit, given that we have received letters
stating that the price has decreased since the initial pricing in the
CY 2011 final rule. See Table 5 for the current component pricing of
the balloon sinus surgery kit.

Table 5--Balloon Sinus Surgery Kit (SA106) Price
----------------------------------------------------------------------------------------------------------------
Supply components Quantity Unit Price
----------------------------------------------------------------------------------------------------------------
kit, sinus surgery, balloon (maxillary, frontal, .............. kit......................... $2,599.86
or sphenoid).
Sinus Guide Catheter.............................. 1 item........................ 444.00
Sinus Balloon Catheter............................ 1 item........................ 820.80
Sinus Illumination System (100 cm lighted 1 item........................ 454.80
guidewire).
Light Guide Cable (8 ft).......................... 1 item........................ 514.80
ACMI/Stryker Adaptor.............................. 1 item........................ 42.00
Sinus Guide Catheter Handle....................... 1 item........................ 66.00
Sinus Irrigation Catheter (22 cm)................. 1 item........................ 150.00
Sinus Balloon Catheter Inflation Device........... 1 item........................ 89.46
Extension Tubing (High Pressure) (20 in).......... 1 item........................ 18.00
----------------------------------------------------------------------------------------------------------------

[[Page 59467]]

We are interested in any information regarding possible changes in
the pricing for this kit or its individual components since the initial
pricing we adopted in CY 2011. The following is a summary of the public
comments we received on our comment solicitation regarding the balloon
sinus surgery kit supply.
Comment: Several commenters stated that the variability inherent in
the underlying patient anatomy makes it extremely difficult to reliably
assign a fixed number of sinuses that can be dilated per balloon or
establish a supply quantity that would constitute the typical case.
These commenters urged CMS to create a separate HCPCS code for the
balloon sinus surgery kit that would be billable based on the number of
balloons used per patient.
Response: As we stated in the proposed rule, we continue to believe
that this option presents a series of potential problems that we have
addressed previously in the context of the broader challenges regarding
our ability to maintain appropriate relativity while pricing high cost
disposable supply items. For a discussion of this issue, we direct the
reader to our discussion in the CY 2011 PFS final rule with comment
period (75 FR 73251).
Comment: One commenter provided extensive information regarding the
pricing and composition of the balloon sinus surgery kit. This
commenter stated that the components of the supply kit have changed
from those listed in Table 5, and that there are multiple different
types of this kit available for purchase. The commenter stated that the
total cost of the balloon sinus surgery kit varies by sinus dilated,
whether navigation is used, and by manufacturer, with the average price
of a basic kit costing $2,204 and the average price of the kit used for
navigation costing $2,850, not including the navigation device itself.
The commenter stated that the kit components should not be individually
priced and that invoices could be made available upon request.
With regards to the number of sinus dilation procedures that
typically can be performed per balloon, the commenter repeated that the
variability inherent in the underlying patient anatomy makes it
extremely difficult to assign a fixed number of sinuses that can be
dilated per balloon. The commenter also urged CMS to consider a shift
away from the current supply methodology and instead create a separate
HCPCS code for the balloon sinus surgery kit which would be billable
based on the number of balloons used per patient. The commenter stated
that should CMS elect to preserve the current policy of assigning a
fixed number of sinus dilations per kit, they recommended maintaining
the current supply quantity that allows one kit for every two sinuses,
as they were unable to find compelling evidence to support a more
appropriate supply amount.
Response: We are particularly interested in the feedback suggesting
that there may be multiple types of balloon sinus surgery kits that
have different prices, and we would be interested in further
information, including invoice submissions, on this subject for future
rulemaking.
After consideration of the public comments, we are not finalizing
any changes to the balloon sinus surgery kit (SA106) supply for CY
2019, outside of the market-based supply and equipment pricing update
to the supply cost. We do not believe that we have sufficient
information to finalize any other changes to the supply cost or supply
quantity in the associated CPT codes at this point in time.
d. Technical Corrections to Direct PE Input Database and Supporting
Files
Subsequent to the publication of the CY 2018 PFS final rule,
stakeholders alerted us to several clerical inconsistencies in the
direct PE database. We proposed to correct these inconsistencies as
described below and reflected in the CY 2019 final direct PE input
database displayed on the CMS website under downloads for the CY 2019
PFS final rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
For CY 2019, we proposed to address the following inconsistencies:
The RUC alerted us that there are 165 CPT codes billed
with an office E/M code more than 50 percent of the time in the
nonfacility setting that have more minimum multi-specialty visit supply
packs (SA048) than post-operative visits included in the code's global
period. This indicates that either the inclusion of office E/M services
was not accounted for in the code's global period when these codes were
initially reviewed by the PE Subcommittee, or that the PE Subcommittee
initially approved a minimum multi-specialty visit supply pack for
these codes without considering the resulting overlap of supplies
between SA048 and the E/M supply pack (SA047). The RUC regarded these
overlapping supply packs as a duplication, due to the fact that the
quantity of the SA048 supply exceeded the number of postoperative
visits, and requested that CMS remove the appropriate number of supply
item SA048 from 165 codes. After reviewing the quantity of the SA048
supply pack included for the codes in question, we proposed to refine
the quantity of minimum multi-specialty visit packs as displayed in
Table 6.

Table 6--Proposed Refinements--Minimum Multispecialty Visit Pack (SA048)
----------------------------------------------------------------------------------------------------------------
Proposed CY
CY 2018 2019
Number of post- nonfacility nonfacility
CPT code op office quantity of quantity of
visits minimum visit minimum visit
pack (SA048) pack (SA048)
----------------------------------------------------------------------------------------------------------------
10040........................................................... 1 2 1
10060........................................................... 1 2 1
10061........................................................... 2 3 2
10080........................................................... 1 2 1
10120........................................................... 1 2 1
10121........................................................... 1 2 1
10180........................................................... 1 2 1
11200........................................................... 1 2 1
11300........................................................... 0 1 0
11301........................................................... 0 1 0
11302........................................................... 0 1 0

[[Page 59468]]

11303........................................................... 0 1 0
11306........................................................... 0 1 0
11307........................................................... 0 1 0
11310........................................................... 0 1 0
11311........................................................... 0 1 0
11312........................................................... 0 1 0
11400........................................................... 1 2 1
11750........................................................... 1 2 1
11900........................................................... 0 1 0
11901........................................................... 0 1 0
12001........................................................... 0 1 0
12002........................................................... 0 1 0
12004........................................................... 0 1 0
12011........................................................... 0 1 0
12013........................................................... 0 1 0
16020........................................................... 0 1 0
17000........................................................... 1 2 1
17004........................................................... 1 2 1
17110........................................................... 1 2 1
17111........................................................... 1 2 1
17260........................................................... 1 2 1
17270........................................................... 1 2 1
17280........................................................... 1 2 1
19100........................................................... 0 1 0
20005........................................................... 1 2 1
20520........................................................... 1 2 1
21215........................................................... 6 7 6
21550........................................................... 1 2 1
21920........................................................... 1 2 1
22310........................................................... 1.5 2.5 1.5
23500........................................................... 2.5 3.5 2.5
23570........................................................... 2.5 3.5 2.5
23620........................................................... 3 4 3
24500........................................................... 4 5 4
24530........................................................... 4 5 4
24650........................................................... 3 4 3
24670........................................................... 3 4 3
25530........................................................... 3 4 3
25600........................................................... 5 6 5
25605........................................................... 5 6 5
25622........................................................... 3.5 4.5 3.5
25630........................................................... 3 4 3
26600........................................................... 4 5 4
26720........................................................... 2 3 2
26740........................................................... 2.5 3.5 2.5
26750........................................................... 2 3 2
27508........................................................... 4 5 4
27520........................................................... 3.5 4.5 3.5
27530........................................................... 4 5 4
27613........................................................... 1 2 1
27750........................................................... 3.5 4.5 3.5
27760........................................................... 4 5 4
27780........................................................... 3.5 4.5 3.5
27786........................................................... 3.5 4.5 3.5
27808........................................................... 4 5 4
28190........................................................... 1 2 1
28400........................................................... 3 4 3
28450........................................................... 2.5 3.5 2.5
28490........................................................... 1.5 2.5 1.5
28510........................................................... 1.5 2.5 1.5
30901........................................................... 0 1 0
30903........................................................... 0 1 0
30905........................................................... 0 1 0
31000........................................................... 1 2 1
31231........................................................... 0 1 0
31233........................................................... 0 1 0
31235........................................................... 0 1 0

[[Page 59469]]

31238........................................................... 0 1 0
31525........................................................... 0 1 0
31622........................................................... 0 1 0
32554........................................................... 0 1 0
36600........................................................... 0 1 0
38220........................................................... 0 1 0
40490........................................................... 0 1 0
42800........................................................... 1 2 1
43200........................................................... 0 1 0
45330........................................................... 0 1 0
46040........................................................... 3 4 3
46050........................................................... 1 2 1
46083........................................................... 1 2 1
46320........................................................... 0.5 1.5 0.5
46600........................................................... 0 1 0
46604........................................................... 0 1 0
46900........................................................... 1 2 1
51102........................................................... 0 2 0
51701........................................................... 0 1 0
51702........................................................... 0 1 0
51703........................................................... 0 1 0
51710........................................................... 0 1 0
51725........................................................... 0 1 0
51736........................................................... 0 1 0
51741........................................................... 0 1 0
51792........................................................... 0 1 0
51798........................................................... 0 1 0
52000........................................................... 0 1 0
52001........................................................... 0 1 0
52214........................................................... 0 1 0
52265........................................................... 0 1 0
52281........................................................... 0 1 0
52285........................................................... 0 1 0
53601........................................................... 0 1 0
53621........................................................... 0 1 0
53660........................................................... 0 1 0
53661........................................................... 0 1 0
54050........................................................... 1 2 1
54056........................................................... 1 2 1
54100........................................................... 0 1 0
54235........................................................... 0 1 0
54450........................................................... 0 1 0
55000........................................................... 0 1 0
56405........................................................... 1 2 1
56605........................................................... 0 1 0
56820........................................................... 0 1 0
57061........................................................... 1 2 1
57100........................................................... 0 1 0
57420........................................................... 0 1 0
57500........................................................... 0 1 0
57505........................................................... 1 2 1
62252........................................................... 0 1 0
62367........................................................... 0 1 0
62368........................................................... 0 1 0
62370........................................................... 0 1 0
64413........................................................... 0 1 0
64420........................................................... 0 1 0
64450........................................................... 0 1 0
64611........................................................... 1 2 1
69000........................................................... 1 2 1
69100........................................................... 0 1 0
69145........................................................... 1.5 2.5 1.5
69210........................................................... 0 1 0
69420........................................................... 1 2 1
69433........................................................... 1 2 1
69610........................................................... 1 2 1
93292........................................................... 0 1 0

[[Page 59470]]

93303........................................................... 0 1 0
94667........................................................... 0 1 0
95044........................................................... 0 0.028 0
95870........................................................... 0 1 0
95921........................................................... 0 1 0
95922........................................................... 0 1 0
95924........................................................... 0 1 0
95972........................................................... 0 1 1
96904........................................................... 0 1 1
----------------------------------------------------------------------------------------------------------------

In general, we proposed to align the number of minimum multi-
specialty visit packs with the number of post-operative office visits
included in these codes. We did not propose any supply pack quantity
refinements for CPT codes 11100, 95974, or 95978 since they are being
deleted for CY 2019. We also did not propose any supply pack quantity
refinements for CPT codes 45300, 46500, 57150, 57160, 58100, 64405,
95970, or HCPCS code G0268 since these codes were reviewed by the RUC
this year and their previous direct PE inputs will be superseded by the
new direct PE inputs we establish through this rulemaking process for
CY 2019.
Comment: One commenter stated that they supported this effort as it
serves to remedy any discrepancies/errors that may be in the PFS
related to postoperative visits and the required multi-specialty packs
needed to render those visits.
Response: We appreciate the support for our proposal from the
commenter.
Comment: One commenter stated that removal of the SA048 supply pack
was inappropriate for CPT code 43200 (Esophagoscopy, flexible,
transoral; diagnostic, including collection of specimen(s) by brushing
or washing, when performed (separate procedure)) as it is required for
the esophagoscopy procedure and the supply is included in the other
codes in the family (CPT codes 43201-43233) as well as for the other GI
endoscopy code families. The commenter requested that CMS not remove
the SA048 supply from CPT code 43200.
Response: After reviewing the supply inputs for the group of codes
identified by the commenter, we agree that it would not be consistent
to remove the SA048 multi-specialty pack from CPT code 43200 while
retaining the supply pack in CPT codes 43201-43233. As a result, we are
not finalizing the removal of the SA048 multi-specialty pack from CPT
code 43200. However, we note that many of the CPT codes in this range
also contain SA048 supply packs without having any postoperative office
visits included in their global periods. We believe that it may be more
accurate to achieve consistency within this range of CPT codes by
removing the SA048 supply pack from all of these codes, as opposed to
adding the SA048 supply pack to CPT code 43200. In regard to this
topic, stakeholders can always provide data to us if they believe the
code is not bundled/valued/etc. correctly.
After consideration of the public comments, we are finalizing our
proposal to align the number of minimum multi-specialty visit packs
with the number of post-operative office visits included in these CPT
codes listed in Table 6, with the exception of CPT code 43200 as
detailed above.
A stakeholder notified us regarding a potential rank order anomaly
in the direct PE inputs established for the Shaving of Epidermal or
Dermal Lesions code family through PFS rulemaking for CY 2013. Three of
these CPT codes describe benign shave removal of increasing lesion
sizes: CPT code 11310 (Shaving of epidermal or dermal lesion, single
lesion, face, ears, eyelids, nose, lips, mucous membrane; lesion
diameter 0.5 cm or less), CPT code 11311 (Shaving of epidermal or
dermal lesion, single lesion, face, ears, eyelids, nose, lips, mucous
membrane; lesion diameter 0.6 to 1.0 cm), and CPT code 11312 (Shaving
of epidermal or dermal lesion, single lesion, face, ears, eyelids,
nose, lips, mucous membrane; lesion diameter 1.1 to 2.0 cm). Each of
these codes has a progressively higher work RVU corresponding to the
increasing lesion diameter, and the recommended direct PE inputs also
increase progressively from CPT codes 11310 to 11311 to 11312. However,
the nonfacility PE RVU we established for CPT code 11311 is lower than
the nonfacility PE RVU for CPT code 11310, which the stakeholder
suggested may represent a rank order anomaly.
We reviewed the direct PE inputs for CPT code 11311 and found that
there were clerical inconsistencies in the data entry that resulted in
the assignment of the lower nonfacility PE RVU for CPT code 11311. We
proposed to revise the direct PE inputs to reflect the ones previously
finalized through rulemaking for CPT code 11311.
Comment: One commenter agreed that a significant clerical error
occurred after the RUC recommended its valuation of CPT code 11311 and
its final acceptance by CMS. The commenter recommended that the direct
PE inputs of CPT code 11310 be replicated for CPT code 11311 and
submitted a table with recommended values.
Response: After reviewing this information, we found that the
direct PE inputs requested by the commenter mostly, but do not
entirely, match the direct PE inputs that CMS finalized through
rulemaking for CY 2013. The commenter requested the inclusion of an
additional SB007 (drape, sterile barrier 16in x 29in) supply and a
SB011 (drape, sterile, fenestrated 16in x 29in) supply while leaving
out a SK075 (skin marking pen, sterile (Skin Skribe)) supply, 3 SM022
(sanitizing cloth-wipe (surface, instruments, equipment)) supplies, and
4 SL463 (Aluminum Chloride 70%) supplies. Since we proposed to revise
the direct PE inputs to match the ones previously finalized through
rulemaking for CPT code 11311, we are not finalizing these five changes
to the direct PE inputs requested by the commenter. In all other
respects, the direct PE inputs recommended by the commenter matched the
direct PE inputs previously finalized through

[[Page 59471]]

rulemaking. We are therefore finalizing our proposal to revise the
direct PE inputs to reflect the ones previously finalized in CY 2013
for CPT code 11311.
In CY 2018, we inadvertently assigned too many minutes of
clinical labor time for the ``Obtain vital signs'' task to three
therapy codes, given that these codes are typically billed in multiple
units and in conjunction with other therapy codes for the same patient
on the same day, and we do not believe that it would be typical for
clinical staff to obtain vital signs for each time a code is reported.
The codes are: CPT code 97124 (Therapeutic procedure, 1 or more areas,
each 15 minutes; massage, including effleurage, petrissage and/or
tapotement (stroking, compression, percussion)); CPT code 97750
(Physical performance test or measurement (e.g., musculoskeletal,
functional capacity), with written report, each 15 minutes); and CPT
code 97755 (Assistive technology assessment (e.g., to restore, augment
or compensate for existing function, optimize functional tasks and/or
maximize environmental accessibility), direct one-on-one contact, with
written report, each 15 minutes).
Therefore, we proposed to refine the ``Obtain vital signs''
clinical labor task for these three codes back to their previous times
of 1 minute for CPT codes 97124 and 97750 and to 3 minutes for CPT code
97755. We also proposed to refine the equipment time for the table,
mat, hi-lo, 6 x 8 platform (EF028) for CPT code 97124 to reflect the
change in the clinical labor time.
Comment: Several commenters agreed with the CMS rationale for
refining the clinical labor task times for each of these codes.
Response: We appreciate the support for our proposal from the
commenters.
Comment: One commenter opposed the CMS proposal to refine the
equipment time for the table, mat, hi-lo, 6 x 8 platform (EF028) for
CPT code 97124 to reflect the change in the clinical labor time.
Response: We continue to believe that changes in clinical labor
time should be matched with corresponding changes in equipment time.
Since the commenter did not supply a rationale as to why the EF028
equipment time should not match the change in clinical labor time, we
are finalizing our proposal to refine the ``Obtain vital signs''
clinical labor task for these three codes back to their previous times
of 1 minute for CPT codes 97124 and 97750 and to 3 minutes for CPT code
97755.
We received a letter from a commenter alerting us to an anomaly in
the direct PE inputs for CPT code 52000 (Cystourethroscopy (separate
procedure)). The commenter stated that the inclusion of an endoscope
disinfector, rigid or fiberoptic, w-cart equipment item (ES005) was
inadvertently overlooked in the recommendations for CPT code 52000 when
it was reviewed during PFS rulemaking for CY 2017, and that the
equipment would be necessary for endoscope sterilization. The commenter
requested that this piece of equipment should be added to the direct PE
inputs for CPT code 52000.
After reviewing the direct PE inputs for this code, we agreed with
the commenter and we proposed to add the endoscope disinfector (ES005)
to CPT code 52000, and to add 22 minutes of equipment time for that
item to match the equipment time of the other non-scope items included
in this code.
Comment: One commenter supported the CMS proposal to add an
endoscope disinfector to CPT code 52000 and to add 22 minutes of
equipment time to match the equipment time of the other non-scope items
included in the code. This commenter requested that this addition apply
to all endoscopic urologic procedures that do not already include the
endoscope disinfector.
Response: We do not agree that the endoscope disinfector should be
added to all endoscopic urologic procedures that lacked the equipment,
as the addition of this equipment to CPT code 52000 is a technical
correction to address a specific anomaly with the recommendations for
CPT code 52000 and not the implementation of a new policy. After
consideration of the public comments, we are finalizing the addition of
22 minutes of equipment time for the endoscope disinfector (ES005) to
CPT code 52000 as proposed.
The following is a summary of the public comments we received on
additional technical corrections to the direct PE input database and
supporting files.
Comment: A commenter stated that they had reviewed the CY 2019
Proposed Rule physician work time file and discovered an issue with 13
CPT codes that had incorrect work times. The commenter stated that
these were technical errors in which the current work time values did
not match what CMS had finalized through rulemaking, and the commenter
requested that these services be corrected in the CY 2019 CMS work time
file for the CY 2019 Final Rule.
Response: We agree with the commenter that some of these CPT codes
are subject to technical corrections, while disagreeing with the
commenter with regards to other CPT codes, as described in more detail
below.
Listed in order, the commenter identified these issues:
Comment: For CPT code 15220 (Full thickness graft, free, including
direct closure of donor site, scalp, arms, and/or legs; 20 sq cm or
less), the commenter stated that their records showed CMS missing 15
min of positioning time from the Harvard study.
Response: We are not finalizing a change in the work time of this
code at this time, as we were unable to verify the positioning time of
CPT code 15220 as originally measured by the Harvard study.
Comment: For CPT code 22558 (Arthrodesis, anterior interbody
technique, including minimal discectomy to prepare interspace (other
than for decompression); lumbar), the commenter stated that the CMS
work time file accidentally double counted postoperative visit time in
the immediate postoperative time field.
Response: We agree with the commenter that this is subject to a
technical correction, and we are finalizing an immediate postservice
work time of 25 minutes for CPT code 22558.
Comment: For CPT code 43760 (Change of gastrostomy tube,
percutaneous, without imaging or endoscopic guidance), the commenter
stated that the code is being deleted for CY 2019 and should not appear
in the work time file.
Response: We agree with the commenter, and we are finalizing the
removal of this code from the work time file.
Comment: For CPT codes 61645 (Percutaneous arterial transluminal
mechanical thrombectomy and/or infusion for thrombolysis, intracranial,
any method, including diagnostic angiography, fluoroscopic guidance,
catheter placement, and intraprocedural pharmacological thrombolytic
injection(s)) and 61650 (Endovascular intracranial prolonged
administration of pharmacologic agent(s) other than for thrombolysis,
arterial, including catheter placement, diagnostic angiography, and
imaging guidance; initial vascular territory), the commenter stated
that CMS incorrectly applied 23 hour stay rule for these codes even
though the RUC recommended these services as typically inpatient. The
commenter stated that there are now available data to see that these
CPT codes are done on an inpatient basis 98 percent and 86 percent of
the time respectively.
Response: We do not believe that the work times of these codes are
subject to

[[Page 59472]]

a technical correction, as the work times finalized for these codes in
the CY 2017 PFS final rule (81 FR 80307-08) were based on a
disagreement in policy with the commenter and not a technical error.
Comment: For CPT code 91200 (Liver elastography, mechanically
induced shear wave (e.g., vibration), without imaging, with
interpretation and report), the commenter stated that the RUC
recommended 5 minutes of immediate postservice work time, not 3
minutes, and that CMS had finalized the code without a time refinement.
The commenter stated that the immediate postservice work time for CPT
code 91200 should be 5 minutes in accordance with the RUC
recommendations.
Response: We investigated the RUC recommendations from the April
2015 RUC meeting when CPT code 91200 was reviewed, and we found that
the RUC recommended an immediate postservice work time of 3 minutes on
the code family's cover sheet and the accompanying summary spreadsheet.
Although the RUC may have intended to recommend an immediate
postservice work time of 5 minutes for this code, we proposed and
finalized an immediate postservice work time of 3 minutes for CPT code
91200 without receiving any comments on the issue. Therefore we are not
finalizing any changes to the work time of CPT code 91200 at this time,
which will remain 3 minutes.
Comment: For CPT codes 93281 (Programming device evaluation (in
person) with iterative adjustment of the implantable device to test the
function of the device and select optimal permanent programmed values
with analysis, review and report by a physician or other qualified
health care professional; multiple lead pacemaker system), 93284
(Programming device evaluation (in person) with iterative adjustment of
the implantable device to test the function of the device and select
optimal permanent programmed values with analysis, review and report by
a physician or other qualified health care professional; multiple lead
transvenous implantable defibrillator system), and 93286 (Peri-
procedural device evaluation (in person) and programming of device
system parameters before or after a surgery, procedure, or test with
analysis, review and report by a physician or other qualified health
care professional; single, dual, or multiple lead pacemaker system),
the commenter stated that CMS has the wrong intraservice work times,
despite the CY 2018 final rule indicating no time refinement for these
codes.
Response: After reviewing the work times for these codes, we agree
with the commenter and we are finalizing a technical correction to the
intraservice work times as recommended.
Comment: For CPT code 97166 (Occupational therapy evaluation,
moderate complexity), the commenter stated that the HCPAC recommended
15 min of immediate postservice work time, not 10 minutes, and that CMS
had finalized the code without a time refinement.
Response: We investigated the RUC recommendations from the October
2015 RUC meeting when CPT code 97166 was reviewed, and we found that
the HCPAC recommendations contained two different values for the
immediately postservice work time. The written recommendations stated
that the immediate postservice work time was recommended at 15 minutes,
while the data on the summary spreadsheet stated that the immediate
postservice work time was recommended at 10 minutes. Although there
were two conflicting HCPAC recommendations for this code, we finalized
in the CY 2017 PFS final rule (81 FR 80331) an immediate postservice
work time of 10 minutes for CPT code 97166 without receiving any
comments on the issue. Therefore we are not finalizing any changes to
the work time of CPT code 97166 at this time.
Comment: For CPT code 33866 (Aortic hemiarch graft including
isolation and control of the arch vessels, beveled open distal aortic
anastomosis extending under one or more of the arch vessels, and total
circulatory arrest or isolated cerebral perfusion (List separately in
addition to code for primary procedure)), the commenter stated that the
RUC recommendation was rescinded and that the code should be removed
from the work time file.
Response: We disagree with the commenter, and we are not finalizing
the removal of CPT code 33866 from the work time file; we refer readers
to the code valuation section of this final rule for additional details
regarding CPT code 33866.
Comment: For CPT code 96X11 (Psychological or neuropsychological
test administration using single instrument, with interpretation and
report by physician or other qualified health care professional and
interactive feedback to the patient, family member(s), or
caregivers(s), when performed), the commenter stated that the code is
not being created for CY 2019 by the CPT Editorial Panel and should be
removed from the work time file.
Response: We agree with the commenter and we are finalizing the
removal of this code from the work time file.
Comment: For HCPCS code G0281 (Electrical stimulation,
(unattended), to one or more areas, for chronic stage iii and stage iv
pressure ulcers, arterial ulcers, diabetic ulcers, and venous stasis
ulcers not demonstrating measurable signs of healing after 30 days of
conventional care, as part of a therapy plan of care), the commenter
stated that their records show an intraservice time for this code of 11
minutes and not 7 minutes as currently listed in the work time file.
Response: We disagree with the commenter. As we stated in the CY
2003 PFS final rule with comment period (67 FR 80014), the work,
practice expense, and malpractice values G0281 are based on a crosswalk
to CPT code 97014 (Application of a modality to 1 or more areas;
electrical stimulation (unattended)), and the intraservice work time of
CPT code 97014 remains 7 minutes.
Comment: Many commenters raised concerns about the use of the
portable X-ray machine (EF041) equipment in CPT code 71045 (Radiologic
examination, chest; single view). Commenters stated that the use of the
portable X-ray machine in CPT code 71045 understated the price of the
equipment typically used in the service, and that the default equipment
utilization rate of 50 percent did not reflect the experience of
portable X-ray suppliers. Commenters supplied an invoice for a Digital
Radiography portable X-ray machine, which they stated would be typical
for use in this procedure, along with data on the equipment utilization
rate that suggested a utilization rate significantly lower than 50
percent would be typical. Commenters requested modifying the direct PE
inputs for CPT code 71045 to include the use of the Digital Radiography
portable X-ray machine at a distinctive utilization rate of
approximately 22 percent, or alternatively, to use the same equipment
as the other three codes in the Chest X-Ray code family (CPT codes
71046-71048) as direct PE inputs for CPT code 71045.
Response: We agree with the commenters and we are finalizing the
replacement of the 9 minutes of equipment time for the portable X-ray
machine (EF041) with 9 minutes of equipment time for a basic radiology
room (EL012) for CPT code 71045. The equipment cost per minute of the
basic radiology room (48.4 cents) is nearly identical to the equipment
cost per

[[Page 59473]]

minute of the proposed Digital Radiography portable X-ray machine (46.0
cents), and we believe that it would better serve the interests of
relativity for CPT code 71045 to match the same equipment inputs as the
rest of the Chest X-Ray code family. We previously updated the PE RVU
of this code in the July 2018 Quarterly Update (CMS Change Request
10644) based on the same information previously supplied by the
commenters, and due to a technical error, this update to the direct PE
inputs of CPT code 71045 was not included in the CY 2019 PFS proposed
rule. We are finalizing this technical correction to the direct PE
inputs of CPT code 71045 for CY 2019.
Comment: One commenter stated that there was a typographical error
in Attachment B of the proposed rule, which resulted in the
misstatement of the total RVUs for CPT code 48554 (Transplantation of
pancreatic allograft). The commenter recommended that we include 74.81
total RVUs for CPT code 48554 to correct the error of 73.70 total RVUs.
Response: We do not agree with the commenter that there was a
typographical error in Addendum B for CPT code 48554, which appears to
sum its component parts of the work RVU (37.80), PE RVU (27.72), and
malpractice RVU (9.29) to the correct total RVU of 74.81.
We also received comments regarding a variety of subjects about
which we did not make proposals for CY 2019. These included comments
regarding: The level of physician supervision for CPT code 99091, the 7
percent reduction to the technical component of computed radiography
services not performed using digital radiography, a request to migrate
the RUC recommended RVU assignment of CPT code 77387 to HCPCS code
G6017, a request that CMS not finalize the proposed changes in payment
for the revascularization codes (CPT codes 37225-37231) that were a
byproduct of the E/M proposals and the supply/equipment pricing update,
a request that CMS should assign direct cost inputs and PE RVUs to
several disposable negative pressure wound therapy codes (CPT codes
97607-97608), a disagreement with previous reductions in the payment
rate for HCPCS code G0416 from past calendar years, a request for
clarification regarding the facility PE RVUs for CPT code 99153, a
request for CMS to provide additional reimbursement stability for
vascular access services by increasing the work RVUs and direct PE
inputs for these codes (CPT codes 36901-36909), and a request for CMS
to study the possible effect of tariffs on the cost of imaging
equipment manufactured overseas. These comments are considered out of
scope for the CY 2019 PFS final rule, as we did not make any proposals
on these issues in the CY 2019 PFS Proposed Rule. We will take the
feedback from the commenters under consideration for future rulemaking.
After consideration of the public comments, we are finalizing
technical corrections to the direct PE input database and supporting
files as described above.
e. Updates to Prices for Existing Direct PE Inputs
In the CY 2011 PFS final rule with comment period (75 FR 73205), we
finalized a process to act on public requests to update equipment and
supply price and equipment useful life inputs through annual
rulemaking, beginning with the CY 2012 PFS proposed rule. For CY 2019,
we proposed the following price updates for existing direct PE inputs.
We proposed to update the price of four supplies and one equipment
item in response to the public submission of invoices. As these pricing
updates were each part of the formal review for a code family, we
proposed that the new pricing take effect for CY 2019 for these items
instead of being phased in over 4 years. For the details of these
proposed price updates, please refer to section II.H. of this final
rule, Table 15: Invoices Received for Existing Direct PE Inputs.
(1) Market-Based Supply and Equipment Pricing Update
Section 220(a) of the Protecting Access to Medicare Act of 2014
(PAMA) (Pub. L. 113-93) provides that the Secretary may collect or
obtain information from any eligible professional or any other source
on the resources directly or indirectly related to furnishing services
for which payment is made under the PFS, and that such information may
be used in the determination of relative values for services under the
PFS. Such information may include the time involved in furnishing
services; the amounts, types and prices of PE inputs; overhead and
accounting information for practices of physicians and other suppliers,
and any other elements that would improve the valuation of services
under the PFS.
As part of our authority under section 1848(c)(2)(M) of the Act, as
added by PAMA, we initiated a market research contract with StrategyGen
to conduct an in-depth and robust market research study to update the
PFS direct PE inputs (DPEI) for supply and equipment pricing for CY
2019. These supply and equipment prices were last systematically
developed in 2004-2005. StrategyGen has submitted a report with updated
pricing recommendations for approximately 1300 supplies and 750
equipment items currently used as direct PE inputs. This report is
available as a public use file displayed on the CMS website under
downloads for the CY 2019 PFS final rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-
Federal-Regulation-Notices.html.
The StrategyGen team of researchers, attorneys, physicians, and
health policy experts conducted a market research study of the supply
and equipment items currently used in the PFS direct PE input database.
Resources and methodologies included field surveys, aggregate
databases, vendor resources, market scans, market analysis, physician
substantiation, and statistical analysis to estimate and validate
current prices for medical equipment and medical supplies. StrategyGen
conducted secondary market research on each of the 2,072 DPEI medical
equipment and supply items that CMS identified from the current DPEI.
The primary and secondary resources StrategyGen used to gather price
data and other information were:
Telephone surveys with vendors for top priority items
(Vendor Survey).
Physician panel validation of market research results,
prioritized by total spending (Physician Panel).
The General Services Administration system (GSA).
An aggregate health system buyers database with discounted
prices (Buyers).
Publicly available vendor resources, that is, Amazon
Business, Cardinal Health (Vendors).
Federal Register, current DPEI data, historical proposed
and final rules prior to FY 2018, and other resources; that is, AMA RUC
reports (References).
StrategyGen prioritized the equipment and supply research based on
current share of PE RVUs attributable by item provided by CMS.
StrategyGen developed the preliminary Recommended Price (RP)
methodology based on the following rules in hierarchical order
considering both data representativeness and reliability.
1. If the market share, as well as the sample size, for the top
three commercial products were available, the weighted average price
(weighted by percent market share) was the reported RP. Commercial
price, as a weighted average of market share, represents a more robust
estimate for each piece of

[[Page 59474]]

equipment and a more precise reference for the RP.
2. If StrategyGen did not have market share for commercial
products, then they used a weighted average (weighted by sample size)
of the commercial price and GSA price for the RP. The impact of the GSA
price may be nominal in some of these cases since it is proportionate
to the commercial samples sizes.
3. Otherwise, if single price points existed from alternate
supplier sites, the RP was the weighted average of the commercial price
and the GSA price.
4. Finally, if no data were available for commercial products, the
GSA average price was used as the RP; and when StrategyGen could find
no market research for a particular piece of equipment or supply item,
the current CMS prices were used as the RP.
After reviewing the StrategyGen report, we proposed to adopt the
updated direct PE input prices for supplies and equipment as
recommended by StrategyGen. For the reasons subsequently discussed, the
GSA price was not incorporated into the calculation for the StrategyGen
recommended prices printed in the proposed rule. The proposed
recommended price was developed as follows:
Recommended CMS Price: The StrategyGen proposed recommended price
was the researched-commercial price, when available. If not, the
StrategyGen proposed recommended price was the current CMS price.
StrategyGen found that despite technological advancements, the
average commercial price for medical equipment and supplies has
remained relatively consistent with the current CMS price.
Specifically, preliminary data indicate that there was no statistically
significant difference between the estimated commercial prices and the
current CMS prices for both equipment and supplies. This cumulative
stable pricing for medical equipment and supplies appears similar to
the pricing impacts of non-medical technology advancements where some
historically high-priced equipment (that is, desktop PCs) has been
increasingly substituted with current technology (that is, laptops and
tablets) at similar or lower price points. However, while there were no
statistically significant differences in pricing at the aggregate
level, medical specialties will experience increases or decreases in
their Medicare payments if CMS were to adopt the pricing updates
recommended by StrategyGen. At the service level, there may be large
shifts in PE RVUs for individual codes that happened to contain
supplies and/or equipment with major changes in pricing, although we
note that codes with a sizable PE RVU decrease would be limited by the
requirement to phase in significant reductions in RVUs, as required by
section 1848(c)(7) of the Act. The phase-in requirement limits the
maximum RVU reduction for codes that are not new or revised to 19
percent in any individual calendar year.
We believe that it is important to make use of the most current
information available for supply and equipment pricing instead of
continuing to rely on pricing information that is more than a decade
old. Given the potentially significant changes in payment that would
occur, both for specific services and more broadly at the specialty
level, we proposed to phase in our use of the new direct PE input
pricing over a 4-year period using a 25/75 percent (CY 2019), 50/50
percent (CY 2020), 75/25 percent (CY 2021), and 100/0 percent (CY 2022)
split between new and old pricing. This approach is consistent with how
we have previously incorporated significant new data into the
calculation of PE RVUs, such as the 4-year transition period finalized
in CY 2007 PFS final rule with comment period when changing to the
``bottom-up'' PE methodology (71 FR 69641). This transition period will
not only ease the shift to the updated supply and equipment pricing,
but will also allow interested parties an opportunity to review and
respond to the new pricing information associated with their services.
We proposed to implement this phase-in over 4 years so that supply
and equipment values transition smoothly from the prices we currently
include to the final updated prices in CY 2022. We proposed to
implement this pricing transition such that one quarter of the
difference between the current price and the fully phased in price is
implemented for CY 2019, one third of the difference between the CY
2019 price and the final price is implemented for CY 2020, and one half
of the difference between the CY 2020 price and the final price is
implemented for CY 2021, with the new direct PE prices fully
implemented for CY 2022. An example of the proposed transition from the
current to the fully-implemented new pricing is provided in Table 7.

Table 7--Example of Direct PE Pricing Transition
----------------------------------------------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------
Current Price...................... $100 ...........................................................
Final Price........................ 200 ...........................................................
Year 1 (CY 2019) Price............. 125 \1/4\ difference between $100 and $200.
Year 2 (CY 2020) Price............. 150 \1/3\ difference between $125 and $200.
Year 3 (CY 2021) Price............. 175 \1/2\ difference between $150 and $200.
Final (CY 2022) Price.............. 200 ...........................................................
----------------------------------------------------------------------------------------------------------------

For new supply and equipment codes for which we establish prices
during the transition years (CYs 2019, 2020 and 2021) based on the
public submission of invoices, we proposed to fully implement those
prices with no transition since there are no current prices for these
supply and equipment items. These new supply and equipment codes would
immediately be priced at their newly established values. We also
proposed that, for existing supply and equipment codes, when we
establish prices based on invoices that are submitted as part of a
revaluation or comprehensive review of a code or code family, they will
be fully implemented for the year they are adopted without being phased
in over the 4-year pricing transition. The formal review process for a
HCPCS code includes a review of pricing of the supplies and equipment
included in the code. When we find that the price on the submitted
invoice is typical for the item in question, we believe it would be
appropriate to finalize the new pricing immediately along with any
other revisions we adopt for the code valuation.
For existing supply and equipment codes that are not part of a
comprehensive review and valuation of a code family and for which we
establish prices based on invoices submitted by the public, we proposed
to implement the established invoice price as the updated price and to
phase in the new price over the remaining years of the proposed 4-year
pricing transition. During the proposed transition period, where price
changes for supplies and

[[Page 59475]]

equipment are adopted without a formal review of the HCPCS codes that
include them (as is the case for the many updated prices we proposed to
phase in over the 4-year transition period), we believe it is important
to include them in the remaining transition toward the updated price.
We also proposed to phase in any updated pricing we establish during
the 4-year transition period for very commonly used supplies and
equipment that are included in 100 or more codes, such as sterile
gloves (SB024) or exam tables (EF023), even if invoices are provided as
part of the formal review of a code family. We would implement the new
prices for any such supplies and equipment over the remaining years of
the proposed 4-year transition period. Our proposal was intended to
minimize any potential disruptive effects during the proposed
transition period that could be caused by other sudden shifts in RVUs
due to the high number of services that make use of these very common
supply and equipment items (meaning that these items are included in
100 or more codes).
We believed that implementing the proposed updated prices with a 4-
year phase-in would improve payment accuracy, while maintaining
stability and allowing stakeholders the opportunity to address
potential concerns about changes in payment for particular items.
Updating the pricing of direct PE inputs for supplies and equipment
over a longer time frame will allow more opportunities for public
comment and submission of additional, applicable data. We welcomed
feedback from stakeholders on the proposed updated supply and equipment
pricing, including the submission of additional invoices for
consideration. We were particularly interested in comments regarding
the supply and equipment pricing for CPT codes 95165 and 95004 that are
frequently used by the Allergy/Immunology specialty. The Allergy/
Immunology specialty was disproportionately affected by the updated
pricing, even with a 4-year phase-in. The direct PE costs for CPT code
95165 would go down from $8.43 to $8.17 as a result of the updated
supply and equipment pricing information. This would result in the PE
RVU for CPT code 96165 to decrease from 0.30 to 0.26. We are seeking
feedback on the supply and equipment pricing for the affected codes
typically performed by this specialty and whether the direct PE inputs
should be reviewed along with the pricing. The full report from the
contractor, including the updated supply and equipment pricing that we
proposed to be implemented over the proposed 4-year transition period,
will be made available as a public use file displayed on the CMS
website under downloads for the CY 2019 PFS final rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
The following is a summary of the public comments we received on
our proposals associated with the market research study to update the
PFS direct PE inputs for supply and equipment pricing.
Comment: Many commenters were concerned with the transparency of
the data used to calculate medical equipment and supply prices. The
commenters were particularly concerned about the use of a subscription-
based benchmark database as a source for pricing data. The commenters
stated that without identification of the database and access to the
precise data used in determining the pricing update, they would have no
systematic way to evaluate pricing accuracy. In addition, these
commenters were concerned that small physician practices are not well
represented in benchmark databases, with the consequence that the
proposed repricing did not reflect the typical price paid by smaller
stakeholders. Commenters stated a general concern that any methodology
that more heavily weighs larger physician groups, group purchasing
organizations (GPOs), or even hospital contract pricing would result in
pricing that is significantly depressed compared to the pricing that
can be obtained by an individual practitioner. The commenters asserted
that this has the potential to pressure the financial viability of
smaller physician practices and to force lower cost non-facility
procedures into hospital outpatient or inpatient sites of service.
Response: As to whether there is sufficient transparency to enable
others to replicate and validate the proposed pricing, the StrategyGen
contractors carried out a market research plan designed to estimate the
typical discounted prices that physicians and other providers normally
pay. The proprietary database of buyer reported pricing is one of the
few sources of typical discounted price data available. Other potential
sources of typical discounted pricing were other proprietary databases
and the publicly available GSA pricing. For each item priced, the
analysis from the contractors included research on as many as five
current sources of prices: (1) A proprietary database of buyer reported
pricing, (2) Prices reported by GSA, (3) Amazon Business, (4) Cardinal
Healthcare, and (5) Vendors' and manufacturers' catalogs.
The proprietary database of buyer reported pricing offers three
advantages: (1) It represents discounted prices as opposed to retail
pricing, (2) It has the largest sample sizes to represent a wider range
of pricing as opposed to single invoices, and (3) The database provides
variety with respect to the purchaser's geographic location, purchasing
method, procedure volume and other purchasing arrangements. We
initially assumed that GSA also represents typical discounted pricing
across regions with smaller sample sizes, but subsequently rejected GSA
data because we did not believe that its prices were typically
representative of commercially available pricing. As a result, GSA data
were not used to calculate the StrategyGen recommended prices included
in the proposed rule. Amazon Business and Cardinal Healthcare represent
typical retail pricing, with smaller sample sizes. In addition, the
StrategyGen contractors utilized vendors' and manufacturers' catalogs
to identify publicly available pricing. Table 8 summarizes sources of
online pricing and characteristics of each source:

Table 8--Market-Based Supply and Equipment Pricing Update Data Sources
----------------------------------------------------------------------------------------------------------------
Variety (that is,
Source of pricing data Discounted pricing Sample size geography, purchasing
arrangement, etc.)
----------------------------------------------------------------------------------------------------------------
Buyers database..................... Actual discounts....... Largest.................. National footprint.
GSA................................. Wholesale price........ 3-5...................... Government purchasers
only.
Amazon Business (on-line)........... Retail price........... 3-5...................... National footprint.
Cardinal Healthcare (on-line)....... Retail price........... 3-5...................... National footprint.
Catalogs (on-line).................. Retail price........... 3-5...................... National footprint.
----------------------------------------------------------------------------------------------------------------

[[Page 59476]]

The Buyers database provides the most accurate market pricing
estimates that include market discounts for a range of buyer
organizations. Its larger sample sizes provide more confidence that the
proposed pricing is not skewed toward higher or lower pricing but
toward the actual market price paid by purchasers.
The StrategyGen contractors chose not to include invoice research
in the market research plan as there is already an existing process to
modify Direct Practice Expense Input (DPEI) prices based on invoices.
Additionally, the contractors determined that providing specific models
and other identifying data with the researched prices would offer a
broader and more consistent source of pricing data. We do not agree
with the commenters that the updated supply and equipment prices will
pressure the financial viability of smaller physician practices, as we
believe that the larger sample sizes obtained by StrategyGen's research
provide more accurate and more consistent pricing of actual market
conditions than the single invoices that we have traditionally been
reliant upon for pricing.
As to whether the proposed pricing is representative of prices
available to small physician practices and non-facility practitioners
generally, one of the objectives of the primary market research was to
understand what kind of discounts are available to small physician
practices similar to discounted pricing available to large health
systems under GPOs. The market research plan included a series of
questions to vendors designed to illuminate typical discounts they
offer to large and small providers other than GPOs. This market
research indicates that there are a variety of discount purchasing
options available. Vendors indicated that both volume and timing can
influence pricing discounts. Approximately 80 percent of respondents
indicated that timing has some impact on the price of equipment, and
about half of respondents indicated that timing had some impact on the
price of supplies. Discussions with other subject matter experts also
indicated that timing of purchase is an important factor in pricing.
For example, the end of the sales cycle can drive discounts. Less than
10 percent of vendors indicated that these timing discounts may not be
available to smaller practices outside of a GPO. The vendor research
also indicated that other factors beyond ``size and timing'' influence
discounted pricing, such as service agreements and bundled purchases.
Research indicates that service agreements often include discounts
for equipment and supplies. For example, longer term service agreements
generally result in larger discounts. However, some vendors indicated
that the effect of service agreements was to reduce the size of the
discounts, negatively impacting providers. This may be a difference in
service agreement strategies across different vendors. Regardless, only
3 percent of respondents indicated that the availability of service
agreement discounts was dependent on a GPO.
The vendors identified other factors that impact pricing decisions
including:
Market demand and competitive pricing;
Contract renewal;
Customer history and contract history; and
Vendor considerations independent of the purchaser such as
manufacturer and sales incentives, revenue goals, and new product
releases.
In conclusion, while volume purchasing and GPOs can drive down
prices for many large providers, these are not the only drivers of
discounts for providers. A number of additional factors applicable to
large, small, and non-facility practices may result in discounts for
the buying organizations. We believe that the pricing update required
looking at a broad range of data that was collected from different
sources, which included pricing data from both large and small
organizations. We note that not all private practices are small in
nature, and we do not agree that it would be more accurate to obtain
prices only from small practices as opposed to the broader data
collection undertaken by the StrategyGen contractor.
Comment: Some commenters were concerned that the researched GSA
price was incorporated into the recommended commercial price. These
commenters expressed concern as to how the GSA price fit into the
calculation of new recommended prices.
Response: We want to clarify how the GSA price was used in
developing the new recommended DPEI prices for equipment and supplies.
We regret the confusion on this issue, which was due to a technical
error in the drafting of the language in the proposed rule. We wish to
clarify that the GSA price was not used to calculate the StrategyGen
recommended prices printed in the proposed rule. Our use of the GSA
website to research supply and equipment pricing was found to have a
number of limitations. Only suppliers that meet stringent
qualifications and that complete a lengthy and detailed application
process are eligible to participate in GSA Advantage, GSA's online
shopping and ordering system. These requirements sharply curtail the
number and type of suppliers whose products may be accessed on the GSA
Advantage website. In addition, only products that are purchased by
federal agencies or other qualified government entities are listed on
the GSA Advantage website, which has the effect of eliminating a number
of medical supplies and equipment that are reflected in the CMS DPEI
codes. This limitation was especially acute when researching bundled
codes for equipment rooms and lanes, and supply packs, kits, and trays.
The GSA website does not record comparable bundled purchasing of
medical equipment or supplies, so no GSA pricing could be recovered for
products included in the bundled codes organized as rooms, lanes,
packs, kits or trays. Finally, the prices listed on the GSA Advantage
website are required to be the supplier's best offer, which may often
be lower than prices that are available to non-governmental purchasers.
For these reasons, the GSA price was not incorporated into the
calculation for the StrategyGen recommended prices printed in the
proposed rule. The final recommended price for CY 2019 was the
commercially researched price, if available. Otherwise the current CY
2018 CMS price remained in place as the CY 2019 CMS price.
Comment: Several commenters were concerned with the methodology
used by StrategyGen to conduct market research to determine an updated
price for medical equipment and supplies. There were significant
concerns with the use of market research to supplement the current AMA/
Specialty Society RVS Update Committee (RUC) process. A number of
commenters stated that CMS should only use invoices supplied by the
specialty society via the RUC process, and should not finalize the
updated prices researched by the StrategyGen contractor.
Response: We determined that the most effective way to update the
DPEI for CY 2019 was through comprehensive market research. The current
RUC process has resulted in updates to many of the equipment and supply
codes, but many of the prices in the CY 2018 DPEI are over a decade
old, and a significant number date back to research conducted 15 years
ago. Therefore, we requested a market research plan from the
StrategyGen contractor designed to research current pricing to estimate
the typical discounted prices that physicians and other providers
normally pay.

[[Page 59477]]

The comprehensive market research plan to update DPEI equipment and
supplies was designed to supplement the AMA RUC process, not replace
it. The current RUC process, while indispensable, does not provide for
comprehensive pricing updates. Under the current process, physicians
and other providers voluntarily submit invoices for items to RUC for
consideration, and after review, the RUC submits these invoices to us.
This process results in inherent biases due to the limited number of
items represented by submitted invoices and due to the voluntary
selection of reported invoices.
The StrategyGen market research plan examined up to five online
sources of current prices for each item of equipment or supply
researched, including: (1) A proprietary database of buyer reported
pricing, (2) Prices offered on GSA (Note: This data was subsequently
excluded from the recommended 2019 CMS prices), (3) Amazon Business,
(4) Cardinal Healthcare, and (5) Vendors' and manufacturers' catalogs.
Each of these sources contains nationally reported vendor and buyer
pricing data. The research plan also included vendor interviews to
clarify the variety of discount programs available to physicians and
other providers.
The comprehensive research plan for the 2019 DPEI required
researching approximately 2,000 supply and equipment codes. Qualitative
and potentially quantitative research to include all the specialty
societies impacted by the DPEI updates was beyond the resources and
time allocated to this update. The market research plan did include a
physician panel with specialists and a general practitioner to review
the reasonableness of the researched data. In addition, the regulatory
process remains available to all specialty societies to comment on the
recommended prices. We encouraged interested stakeholders to continue
to provide feedback on supply and equipment pricing, including the
submission of invoices, throughout the 4-year pricing transition.
Comment: Several commenters stated that there is an inherent bias
to prioritizing the medical equipment and supplies based on spending
and code utilization. These commenters stated that any attempt to
accurately price items in the supply and equipment list should devote
equal effort to each item of equipment or supply and should not devote
additional attention to the most utilized codes. These commenters
stated that using utilization data as the primary driver for
identifying supply and equipment items to review suggests that there
may have been specific intent to lower the cost of high utilization
items, perhaps to the detriment of pricing accuracy. In addition, there
was concern that some underutilized codes were not researched.
Response: To control for potential research bias, the StrategyGen
market research team used an identical online methodology to research
commercial pricing data for each of the supply and equipment codes,
regardless of the code's prioritization. The prioritization of high-
utilization supply and equipment codes was not designed to reduce
prices for these codes.
The prioritization of supply and equipment codes was designed to
facilitate understanding and validation of the researched commercial
prices for these items. Surveying other market entities, including
vendors, as opposed to buyers, was used to more precisely identify the
range of commercial pricing and factors impacting those prices. For
example, additional priority research included a physician panel that
reviewed the researched commercial prices for reasonableness. The
prioritization of research for certain codes did not change the
recommended commercial prices.
In addition, limited time and resources required prioritizing the
codes based on use. We recognize that a few medical supply and
equipment codes do not have updated recommended prices, and we continue
to welcome the submission of updated pricing information from
stakeholders for these and other codes.
Comment: Many commenters were supportive of the proposal to use a
4-year pricing transition. Commenters agreed with using the transition
period as an opportunity for specialty societies and other stakeholders
to continue to evaluate the new pricing and submit invoices and other
pricing data as needed. Commenters who disagreed with the use of the 4-
year pricing transition also requested that CMS not finalize the
proposal. One commenter stated that CMS should phase in the new prices
for equipment and supplies during a shorter transition period than the
proposed 4-year transition, and suggested a 2-year transition instead.
Response: Our proposal was intended to minimize any potential
disruptive effects during the proposed transition period, and we
continue to believe that implementing the proposed updated prices with
a 4-year phase-in will improve payment accuracy, while maintaining
stability and allowing stakeholders the opportunity to address
potential concerns about changes in payment for particular items.
Updating the pricing of direct PE inputs for supplies and equipment
over a longer time frame will allow more opportunities for public
comment and submission of additional, applicable data.
Comment: Several commenters stated that CMS should consider
delaying implementation of this proposal until there could be a more
thorough and adequate review of the inputs and give medical societies
and/or practices more time to gather invoices in order to determine if
the proposed pricing is accurate. Some commenters similarly requested
that the 4-year pricing transition should begin in CY 2020 to provide
stakeholders with additional time to evaluate the approach used by
StrategyGen. A few commenters stated that they would prefer a delay of
more than 1 year before implementation began.
Response: We disagree with the commenters that delaying the
implementation of the pricing updates for a year or longer would lead
to more accurate pricing. We believe that our proposal to update the
pricing of direct PE inputs for supplies and equipment over a 4 year-
transition already allows many opportunities for public comment and the
submission of additional, applicable data. We welcomed feedback from
commenters on the proposed updated supply and equipment pricing,
including the submission of additional invoices for consideration, and
many commenters provided detailed feedback regarding the pricing of
individual supply and equipment items. We note that we received
feedback from commenters on approximately 65 individual supply and
equipment codes, which is roughly 3 percent of the total number of
items we proposed to update. We also note that commenters did not
identify an alternative source for pricing information outside of the
sources employed by the StrategyGen contractors, with commenters
largely suggesting that we should continue to rely on invoice
submissions included along with the review of individual codes via the
RUC process.
We continue to believe that a delay in implementation would be
unlikely to result in more accurate pricing information. Therefore, we
are finalizing the 4-year pricing transition, beginning in CY 2019. We
look forward to working with commenters over the 4-year transition for
assistance in identifying individual supply and equipment codes that
may require additional research into their pricing. As a reminder, to
be included in a given year's proposed rule, we generally need to
receive invoices by the same February 10th

[[Page 59478]]

deadline used for consideration of RUC recommendations. However, we
would consider invoices submitted as public comments during the comment
period following the publication of the PFS proposed rule, and would
consider any invoices received after February 10th or outside of the
public comment process as part of our established annual process for
requests to update supply and equipment prices for the following year.
Comment: Many commenters addressed the proper pricing of some
multi-component items, including supply kits, packs, and trays as well
as some items of equipment. Several commenters noted some of the
proposed prices for supply and equipment items that contain multiple
components may not accurately reflect all the components, while other
commenters noted that some of the components could be improperly
priced. Commenters expressed concerns that some equipment may not
possess precise components that are necessary for a specific procedure.
Response: Using the information provided by these commenters, the
StrategyGen contractors re-examined the pricing of the multi-component
supply and equipment items that had been identified. In some instances,
the additional research confirmed some commenters' concerns, as the
contractors found that a limited set of these multi-item supply and
equipment kits required further clarification of components. For
example, an item within a kit, pack, or tray may have had an updated
component, resulting in a mispriced item within that kit. To further
clarify the prices of these kits, the kits were broken into their most
basic components and priced individually. The total price of the kit
was determined by adding the specific item prices together. If one of
the items within a kit was misidentified, it resulted in an incorrect
price of the entire kit.
For example, a review of the recommended price for the ``Antigens,
multi'' (SH007) supply code identified the need to add pricing data for
additional antigens and to refine the unit of measurement used in
calculating the price. For SH007, additional antigens were added and
data analyzed for 1 milliliter vials of two allergy antigens. The first
antigen is an allergy antigen for pollen and mites and contains
antigens for Timothy, Birch, Ragweed, Cocklebur, MarshElde, and the
mites Dermatophagoides pteronyssinus and Dermatophagoides farina. The
second antigen is an allergy antigen for mold and cats and contains
antigens for Alternaria, Helminth, Hormoden, Penicillium, and Fel d1.
To determine the price of the allergy antigen, the StrategyGen
contractor researched each component of the antigen separately and
averaged the price of the separate vials as the recommended price to
arrive at an updated recommended price of $8.96.
In instances related to equipment, an item may have been improperly
priced because a specific component was omitted but the items priced
could perform the requisite task. An example of this occurred in the
pricing of the ``SRS System, SBRT'' (ER083) equipment item where the
equipment priced would retrofit a system to perform SBRT procedures,
but pricing did not include the linear accelerator. When re-examining
this specific medical equipment, we ensured it was a linear accelerator
with SBRT capabilities and arrived at an updated recommended price of
$2,973,721.83.
We reexamined the recommended price of each multi-component item
cited by a commenter. Table 9 at the conclusion of this section lists
the supply and equipment codes with price changes based on feedback
from the commenters and the resulting additional research into pricing.
Comment: Several commenters questioned the prices of certain supply
codes based on their conclusion that the quantity of the items priced
was inaccurate. Depending on the type of supply, a number of different
units of measurement are used to set prices for DPEI supply codes.
Commenters stated that StrategyGen had used the incorrect unit of
measurement in their recommended prices, and identified specific supply
codes where they believed these errors had taken place.
Response: In each instance in which a commenter questioned the
accuracy of a DPEI code's recommended price based on a concern about
the unit quantity of the item priced, the StrategyGen contractor
conducted further research of the item and its price with special
attention to ensuring that the recommended price was based on the
clarified unit of measure. The price assigned to a given code may be
for a single item, a kit, a tray, or it may be based on a per test or
per ml basis. For example, the price for the SG055 supply is for a
single sterile 4in x 4in gauze sponge; whereas the price for SG056 is
for a tray/pack of 10 sterile 4in x 4in gauze sponges. In other
situations, such as the ``Embedding Mold'' (SL060) supply, the price
for a package of multiple molds was reported instead of the price of a
single embedding mold. After consideration of comments received and
additional price research, we have updated the recommended prices for a
number of relevant supply codes identified by the commenters. Table 9
at the conclusion of this section lists the supply and equipment codes
with price changes based on feedback from the commenters and the
resulting additional research into pricing.
Comment: Several commenters addressed the subject of the proper
pricing for certain items of medical supply and equipment. These
commenters requested these specific CMS codes be reviewed again to
ensure the correct items were being researched and priced accordingly.
Response: Based on the commenters' requests, the StrategyGen
contractor conducted an extensive examination of the pricing of any
supply or equipment items that any commenter identified as requiring
additional review. Invoices submitted by multiple commenters were
greatly appreciated and ensured that medical equipment and supplies
were re-examined and clarified. Multiple researchers reviewed these
specified supply and equipment codes for accuracy and proper pricing.
In most cases, the contractor also reached out to a team of nurses and
their physician panel to further validate the accuracy of the data and
pricing information. In some cases, the pricing for individual items
needed further clarification due to a lack of information or due to
significant variation in packaged items. An example of such
clarification occurred with the ``Covered Stent (Viabahn, Gore)''
(SD254) supply, which encompasses a wide range of stents, with varying
sizes and other qualities. In other cases, such as the ``Patient Worn
Telemetry System'' (EQ340) equipment, an inpatient unit was originally
priced as opposed to an outpatient unit. After an extensive review and
validation process, we updated our recommended prices for a number of
supply and equipment codes. Table 9 at the conclusion of this section
lists the supply and equipment codes with price changes based on
feedback from the commenters and the resulting additional research into
pricing.
Comment: Several commenters expressed concerns with the proposed
prices for individual supply and equipment codes, and recommended that
the price of these codes remain unchanged until additional research can
be conducted.
Response: The StrategyGen contractor investigated the accuracy of
components or features included in an item by researching the identity
of the item based on the description contained in the item's supply or
equipment code, as well as the identity of any item's prices

[[Page 59479]]

in submitted invoices. Additional research into approximately half a
dozen supply/equipment codes failed to produce reliable product data
sufficient to calculate a recommended price. To price these equipment
and supply items accurately, we believe additional information is
required. Therefore, we will continue to use the current CMS price for
these supply and equipment items pending additional research and
analysis. We welcome the submission of updated pricing information
regarding these supply and equipment items through submission of valid
invoices from commenters and other stakeholders. These supply and
equipment codes are also listed in Table 9 at the conclusion of this
section.
Comment: A few commenters stated that CMS should ensure that the
direct practice expenses for HCPCS codes G6001-G6015 are applied
consistent with the directives of the Patient Access and Medicare
Protection Act (PAMPA) (Pub. L. 114-115) and the Bipartisan Budget Act
(BBA) of 2018 (Pub. L. 115-123). Commenters stated that Congress
established via statute that the direct PE inputs for these radiation
treatment delivery services furnished in CY 2017, CY 2018, and CY 2019
shall be the same as such inputs as established for these services in
CY 2016. These commenters stated that the proposed changes to the PE
RVUs for HCPCS codes G6001-G6015 were directly opposed to current law,
and that CMS should revisit its analysis to ensure that the direct PE
inputs are consistent with those used in 2016 as required by Congress.
Response: We disagree with the commenters that the proposed direct
PE inputs for HCPCS codes G6001-G6015 were not applied consistent with
the directives established in the PAMPA and the BBA. The statute at
section 1848(b)(11) of the Act (as added by the PAMPA and amended)
specifies that the code definitions, work RVUs, and direct inputs for
the practice expense RVUs for these services shall be the same as such
definitions, units, and inputs for such services for the fee schedule
established for services furnished in CY 2016. We did not propose to
change the code definitions, work relative value units, or direct
practice expense inputs from those established for CY 2016. We proposed
to update the pricing of those same supply and equipment inputs as part
of the market-based study of commercial pricing undertaken by the
contractor, which was not a subject addressed by the statutory
provisions concerning HCPCS codes G6001-G6015. We did not propose
changes to the direct practice expense inputs for these services. We
simply proposed to update pricing for these inputs; and to adopt the
same prices for these supplies and equipment across the PFS for all
codes that include them. We note that we estimate that the overall
effect of incorporating the new prices in calculating the payment rates
for these services results in higher overall RVUs for these services,
on the whole, than the potential alternative of relying exclusively on
pricing from prior years.
After consideration of the public comments, we are finalizing our
proposals associated with the market research study to update the PFS
direct PE inputs for supply and equipment pricing. We continue to
believe that implementing the proposed updated prices with a 4-year
phase-in will improve payment accuracy, while maintaining stability and
allowing stakeholders the opportunity to address potential concerns
about changes in payment for particular items. We continue to welcome
feedback from stakeholders on the proposed updated supply and equipment
pricing, including the submission of additional invoices for
consideration. However, while we are adopting most of the prices for
supplies and equipment as recommended by StrategyGen and included in
the proposed rule, in response to the initial feedback provided by the
commenters, we are finalizing changes to the proposed pricing of
approximately 60 supply and equipment codes as detailed in Table 9:

Table 9--Supply and Equipment Prices Updated in Response to Comments
----------------------------------------------------------------------------------------------------------------
Proposed CY Final CY 2019
Supply/ equipment code Description CY 2018 price 2019 price price
----------------------------------------------------------------------------------------------------------------
ED033.......................... treatment planning system, IMRT $350,545.000 $157,392.835 $197,247.000
(Corvus w-Peregrine 3D Monte
Carlo).
EF031.......................... table, power................... 6,153.630 5,438.120 5,906.760
EL015.......................... room, ultrasound, general...... 369,945.000 130,252.571 369,945.000
EL016.......................... Room--Ultrasound, vascular/ 466,492.000 199,449.308 466,492.000
Original submission.
EP014.......................... flow cytometer................. 119,850.000 147,210.980 192,000.000
EP088.......................... ThermoBrite.................... 6,120.000 3,467.000 4,795.000
EP116.......................... VP-2000 Processor.............. 30,800.000 81,775.462 37,993.000
EQ031.......................... INR monitor, home.............. 2,000.000 6,014.819 635.000
EQ125.......................... glucose continuous monitoring 1,170.540 835.527 850.000
system.
EQ288.......................... ultrasonic cleaning unit....... 895.000 76,725.556 895.000
EQ312.......................... INR analysis and reporting 21,085.000 6,014.819 19,325.000
system w-software.
EQ340.......................... Patient Worn Telemetry System.. 23,537.000 18,565.719 23,494.000
EQ343.......................... Radioaerosol Administration 2,560.250 30.000 623.000
System.
ER003.......................... HDR Afterload System, 375,000.000 111,425.876 132,574.780
Nucletron--Oldelft.
ER083.......................... SRS system, SBRT, six systems, 4,000,000.000 931,965.479 2,973,721.836
average.
ES052.......................... brachytherapy treatment vault.. 175,000.000 134,998.000 193,114.250
SA026.......................... kit, radiofrequency introducer. 50.000 658.700 24.160
SA074.......................... kit, endovascular laser 519.000 313.460 323.330
treatment.
SA081.......................... pack, drapes, ortho, small..... 1.128 1.000 2.250
SA099.......................... Kit, probe, cryoablation, 4,700.000 1,539.560 1,539.560
prostate (Galil-Endocare).
SA100.......................... kit, probe, radiofrequency, XIi- 2,695.000 753.420 1,966.670
enhanced RF probe.
SA105.......................... UroVysion test kit............. 176.800 132.130 129.280
SA106.......................... Balloon Sinus Surgery Kit...... 2,599.860 2,876.220 2,374.330
SA117.......................... Universal Detection Kit........ 4.000 6.510 4.000
SA122.......................... Claravein Kit.................. 890.000 575.000 883.330
SB019.......................... drape-towel, sterile 18in x 0.282 0.920 0.470
26in.
SB026.......................... gown, patient.................. 0.533 3.540 0.590
SD109.......................... probe, radiofrequency, 3 array 2,233.000 871.660 2,289.000
(StarBurstSDE).
SD114.......................... sensor, glucose monitoring 53.080 43.950 59.310
(interstitial).

[[Page 59480]]

SD134.......................... tubing, suction, non-latex 2.961 0.290 2.670
(6ft) with Yankauer tip (1).
SD155.......................... catheter, RF endovenous 725.000 1,010.550 550.000
occlusion.
SD250.......................... introducer sheath, Ansel [45 cm 90.000 64.450 72.640
6 Fr Ansel].
SD251.......................... Sheath Shuttle (Cook).......... 0.000 0.000 109.690
SD253.......................... atherectomy device 4,979.670 2,293.100 3,048.330
(Spectronetics laser or Fox
Hollow).
SD254.......................... covered stent (VIABAHN, Gore).. 3,768.000 2,573.000 3,129.000
SD255.......................... Reentry device (Frontier, 0.000 0.000 2,343.120
Outback, Pioneer).
SD304.......................... IVUS catheter.................. 1,025.000 727.750 858.330
SF040.......................... suture, vicryl, 3-0 to 6-0, p, 7.852 4.310 8.520
ps.
SG055.......................... gauze, sterile 4in x 4in....... 0.159 0.030 0.190
SG056.......................... gauze, sterile 4in x 4in (10 0.798 0.030 1.200
pack uou).
SH007.......................... antigen, multi (pollen, mite, 6.700 4.780 8.960
mold, cat).
SH009.......................... antigen, venom................. 20.140 27.360 30.930
SH010.......................... antigen, venom, tri-vespid..... 44.050 51.320 60.240
SH033.......................... fluorescein inj (5ml uou)...... 5.442 10.310 24.390
SJ055.......................... test strip, INR................ 5.660 3.750 4.710
SL012.......................... antibody IgA FITC.............. 41.180 274.090 30.025
SL060.......................... embedding mold................. 0.149 5.140 0.123
SL182.......................... mounting media (DAPI II 67.000 14.420 54.000
counterstain).
SL184.......................... slide, negative control, Her-2. 29.400 21.240 29.400
SL185.......................... slide, positive control, Her-2. 29.400 25.000 26.200
SL191.......................... ethanol, 85%................... 0.003 0.170 0.021
SL195.......................... kit, FISH paraffin pretreatment 20.850 23.290 20.850
SL196.......................... kit, HER-2/neu DNA Probe....... 105.000 80.450 79.050
SL258.......................... Control slides................. 228.000 279.000 203.730
SL261.......................... FISH pre-treatment kit......... 549.000 454.480 579.210
SL474.......................... Confirm anti-CD15 Mouse 3.610 3.880 3.820
Monoclonal Antibody (Ventana
760-2504).
SL483.......................... Hematoxylin II (Ventana 790- 0.023 0.023 0.780
2208).
SL484.......................... Bluing reagent (Ventana 760- 4.522 0.290 0.450
2037).
SL488.......................... UltraView Universal DAB 10.485 15.390 9.700
Detection Kit.
SL493.......................... Antibody Estrogen Receptor 14.470 322.400 16.117
monoclonal.
SL497.......................... (EBER) DNA Probe Cocktail...... 8.570 420.060 8.189
SL498.......................... Kappa Probe Cocktail........... 0.095 0.070 0.910
----------------------------------------------------------------------------------------------------------------

The updated supply and equipment pricing as it will be implemented
over the 4-year transition period will be made available as a public
use file displayed on the CMS website under downloads for the CY 2019
PFS final rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
To maintain relativity between the clinical labor, supplies, and
equipment portions of the PE methodology, we believe that the rates for
the clinical labor staff should also be updated along with the updated
pricing for supplies and equipment. We solicited public comment
regarding whether to update the clinical labor wages used in developing
PE RVUs in future calendar years during the 4-year pricing transition
for supplies and equipment, or whether it would be more appropriate to
update the clinical labor wages at a later date following the
conclusion of the transition for supplies and equipment, for example,
to avoid other potentially large shifts in PE RVUs during the 4-year
pricing transition period.
The following is a summary of the public comments we received on
our comment solicitation regarding whether to update of the rates for
the clinical labor staff types during the 4-year pricing transition for
supplies and equipment.
Comment: Most commenters were supportive of the idea of updating
the clinical labor wages during the 4-year pricing transition for
supplies and equipment. Several commenters requested that the updated
pricing for clinical labor should continue to be based on Bureau of
Labor Statistics wage data and remain open for public comment from
interested commenters through the rulemaking process. One commenter
supported updating the prices for the clinical labor staff types and
stated that they had convened an expert physician panel that suggested
that the clinical labor costs for radiation therapists and nurses are
up to 33 percent higher than what is currently included in the CMS
database. A few commenters did not support updating clinical labor
wages during the 4-year pricing transition for supplies and equipment,
in one case stating that the clinical labor pricing should be updated
after the pricing transition for supplies and equipment was complete,
and in another case stating that CMS should not make any changes to
clinical labor costs for the foreseeable future.
Response: We will take this information into account for future
rulemaking on the subject of whether or not to update the clinical
labor wages used in future calendar years alongside the 4-year pricing
transition for supplies and equipment.
(2) Breast Biopsy Software (EQ370)
Following the publication of the CY 2018 PFS final rule, a
stakeholder contacted us and requested that we update the price for the
Breast Biopsy software (EQ370) equipment. This equipment item currently
lacks a price in the direct PE database, and when an invoice for the
Breast Biopsy software was first submitted during CY 2014 PFS
rulemaking, we stated that this item served clinical functions similar
to other items already included in the Magnetic Resonance (MR) room
equipment package (EL008) included in the same CPT codes under review.
Therefore, we did not create new direct PE inputs for this equipment
item (78 FR 74344

[[Page 59481]]

through 74345). The stakeholder suggested that this software is used to
subtract the imaging raw data series from the MRI Scanner, reformat the
images in multiple planes to allow accurate targeting of the lesion to
be biopsied, identify the location of a fiducial marker on the
patient's skin, and then target the location of the enhancing lesion to
be biopsied. The stakeholder requested that EQ370 be renamed as
``Breast MRI computer aided detection and biopsy guidance software''
and added to existing CPT codes 19085 (Biopsy, breast, with placement
of breast localization device(s) (e.g., clip, metallic pellet), when
performed, and imaging of the biopsy specimen, when performed,
percutaneous; first lesion, including magnetic resonance guidance),
19086 (Biopsy, breast, with placement of breast localization device(s)
(e.g., clip, metallic pellet), when performed, and imaging of the
biopsy specimen, when performed, percutaneous; each additional lesion,
including magnetic resonance guidance), 19287 (Placement of breast
localization device(s) (e.g., clip, metallic pellet, wire/needle,
radioactive seeds), percutaneous; first lesion, including magnetic
resonance guidance), and 19288 (Placement of breast localization
device(s) (e.g., clip, metallic pellet, wire/needle, radioactive
seeds), percutaneous; each additional lesion, including magnetic
resonance guidance), as well as adding the equipment to two newly
created MR breast codes with CAD, CPT codes 77048 (Magnetic resonance
imaging, breast, without and with contrast material(s), including
computer-aided detection (CAD-real time lesion detection,
characterization and pharmacokinetic analysis) when performed;
unilateral) and 77049 (Magnetic resonance imaging, breast, without and
with contrast material(s), including computer-aided detection (CAD-real
time lesion detection, characterization and pharmacokinetic analysis)
when performed; bilateral). The stakeholder supplied an invoice with a
purchase price of $52,275 for the equipment.
After reviewing the use of the Breast Biopsy software (EQ370)
equipment in these six codes, we did not propose to update the price or
add the software to these procedures. As we stated in the CY 2014 PFS
final rule with comment period (78 FR 74345), we continue to believe
that equipment item EQ370 serves clinical functions similar to other
items already included in the MR room equipment package (EL008), and
that it would be duplicative to include this Breast Biopsy software as
a separate direct PE input. We also note that the RUC recommendations
for the new CPT codes 77048 and 77049 do not include EQ370 in the
recommended equipment for these procedures, and we do not have any
reason to believe that the inclusion of additional Breast Biopsy
software beyond what is already contained in the MR room equipment
package would be typical. However, we will update the name of the EQ370
equipment item from ``Breast Biopsy software'' to the requested
``Breast MRI computer aided detection and biopsy guidance software'' to
help better describe the equipment in question.
The following is a summary of the public comments we received on
our proposal not to update the price of the Breast Biopsy software or
add the software to the listed procedures.
Comment: Several commenters stated that CAD or biopsy software is
not part of any standard MRI room package available for purchase, and
that these are different equipment items sold by different vendors. One
commenter requested that CMS clarify the equipment items that make up
the MR room (EL008) in order to verify whether or not legitimate
duplication exists with the Breast Biopsy software. Another commenter
stated that the new CAD Software equipment (ED058) in CPT codes 77048
and 77049 is actually synonymous with the ``breast biopsy software''
(EQ370). This commenter stated that there had been a lack of
consistency in identifying the equipment item between the breast biopsy
codes and the MR breast codes, and requested updating the price of the
equipment item consistent with the submitted invoices.
Response: In response to the comment requesting that CMS clarify
the equipment items that make up the MR room (EL008), we can state that
the MR room contains a 1.5T MR Scanner as well as coils, NV array,
torso array, shoulder, wrist, extremity, dual array, power injector,
and a computer workstation.
After consideration of the public comments, we are finalizing our
proposal not to update the price of the Breast Biopsy software (EQ370).
However, we note that in light of the information supplied by the
commenter that the new CAD Software equipment (ED058) is actually
synonymous with the Breast Biopsy software (EQ370), we had already
proposed to include this equipment in CPT codes 77048 and 77049. We are
finalizing the inclusion of the new CAD Software equipment (ED058) in
these procedures, and we are finalizing an update in the price of the
CAD Software to $43,308.12. This is based on a submitted invoice from
the commenters which contained a price of $52,725 as averaged together
with additional invoices for the same CAD Software equipment researched
by the StrategyGen contractor. We are also finalizing the replacement
of the time assigned to the EQ370 Breast Biopsy software in CPT codes
19085, 19086, 19287, and 19288 with an equal amount of time assigned to
the new ED058 CAD Software equipment. Finally, due to the continued
confusion and lack of price for the EQ370 equipment item, and due to
its redundancy with the new ED058 equipment code, we are deleting
EQ370.
(3) Invoice Submission
We routinely accept public submission of invoices as part of our
process for developing payment rates for new, revised, and potentially
misvalued codes. Often these invoices are submitted in conjunction with
the RUC-recommended values for the codes. For CY 2019, we noted that
some stakeholders have submitted invoices for new, revised, or
potentially misvalued codes after the February 10th deadline
established for code valuation recommendations. To be included in a
given year's proposed rule, we generally need to receive invoices by
the same February 10th deadline we noted for consideration of RUC
recommendations. However, we would consider invoices submitted as
public comments during the comment period following the publication of
the PFS proposed rule, and would consider any invoices received after
February 10th or outside of the public comment process as part of our
established annual process for requests to update supply and equipment
prices.
(4) Adjustment to Allocation of Indirect PE for Some Office-Based
Services
In the CY 2018 PFS final rule (82 FR 52999 through 53000), we
established criteria for identifying the services most affected by the
indirect PE allocation anomaly that does not allow for a site of
service differential that accurately reflects the relative indirect
costs involved in furnishing services in nonfacility settings. We also
finalized a modification in the PE methodology for allocating indirect
PE RVUs to better reflect the relative indirect PE resources involved
in furnishing these services. The methodology, as described, is based
on the difference between the ratio of indirect PE to work RVUs for
each of the codes meeting eligibility criteria and the ratio of
indirect PE to work RVU for the most commonly reported visit code. We
refer readers to the CY 2018 PFS final

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rule (82 FR 52999 through 53000) for a discussion of our process for
selecting services subject to the revised methodology, as well as a
description of the methodology, which we began implementing for CY 2018
as the first year of a 4-year transition. For CY 2019, we proposed to
continue with the second year of the transition of this adjustment to
the standard process for allocating indirect PE.
We received no comments specific to our proposal to continue with
the 2nd year of the transition to the standard process for allocating
indirect PE. Therefore, we are finalizing our proposal to proceed with
the second year of implementing an alternative methodology for the
allocation of indirect PE for some office-based services.

C. Determination of Malpractice Relative Value Units (RVUs)

1. Overview
Section 1848(c) of the Act requires that the payment amount for
each service paid under the PFS be composed of three components: Work;
PE; and malpractice (MP) expense. As required by section
1848(c)(2)(C)(iii) of the Act, beginning in CY 2000, MP RVUs are
resource-based. Section 1848(c)(2)(B)(i) of the Act also requires that
we review, and if necessary adjust, RVUs no less often than every 5
years. In the CY 2015 PFS final rule with comment period, we
implemented the third review and update of MP RVUs. For a comprehensive
discussion of the third review and update of MP RVUs see the CY 2015
PFS proposed rule (79 FR 40349 through 40355) and final rule with
comment period (79 FR 67591 through 67596).
To determine MP RVUs for individual PFS services, our MP
methodology is composed of three factors: (1) Specialty-level risk
factors derived from data on specialty-specific MP premiums paid by
practitioners; (2) service level risk factors derived from Medicare
claims data of the weighted average risk factors of the specialties
that furnish each service; and (3) an intensity/complexity of service
adjustment to the service level risk factor based on either the higher
of the work RVU or clinical labor RVU. Prior to CY 2016, MP RVUs were
only updated once every 5 years, except in the case of new and revised
codes.
In the CY 2016 PFS final rule with comment period (80 FR 70906
through 70910), we finalized a policy to begin conducting annual MP RVU
updates to reflect changes in the mix of practitioners providing
services (using Medicare claims data), and to adjust MP RVUs for risk,
intensity and complexity (using the work RVU or clinical labor RVU). We
also finalized a policy to modify the specialty mix assignment
methodology (for both MP and PE RVU calculations) to use an average of
the 3 most recent years of data instead of a single year of data. Under
this approach, for new and revised codes, we generally assign a
specialty risk factor to individual codes based on the same utilization
assumptions we make regarding the specialty mix we use for calculating
PE RVUs and for PFS budget neutrality. We continue to use the work RVU
or clinical labor RVU to adjust the MP RVU for each code for intensity
and complexity. In finalizing this policy, we stated that the
specialty-specific risk factors would continue to be updated through
notice and comment rulemaking every 5 years using updated premium data,
but would remain unchanged between the 5-year reviews.
In CY 2017, we finalized the 8th GPCI update, which reflected
updated MP premium data. We did not propose to use the updated MP
premium data to propose updates for CY 2017 to the specialty risk
factors used in the calculation of MP RVUs because it was inconsistent
with the policy we previously finalized in the CY 2016 PFS final rule
with comment period. That is, we indicated that the specialty-specific
risk factors would continue to be updated through notice and comment
rulemaking every 5 years using updated premium data, but would remain
unchanged between the 5-year reviews. However, we solicited comment on
whether we should consider doing so, perhaps as early as for CY 2018,
prior to the fourth review and update of MP RVUs that must occur no
later than CY 2020. After consideration of the comments received, we
stated in the CY 2017 PFS final rule that we would consider the
possibility of using the updated MP data to update the specialty risk
factors used in the calculation of the MP RVUs prior to the next 5-year
update in future rulemaking (81 FR 80191 through 80192).
In the CY 2018 PFS proposed rule, we proposed to use the updated MP
data to update the specialty risk factors used in calculation of the MP
RVUs prior to the next 5-year update (CY 2020). However, in the CY 2018
PFS final rule (82 FR 53000 through 53006), after consideration of the
comments received and some differences we observed in the descriptions
on the raw rate filings as compared to how those data were categorized
to conform with the CMS specialties, we did not finalize our proposal
to use the updated MP data. We are required to review, and if
necessary, adjust the MP RVUs by CY 2020. We appreciate the feedback
provided by commenters in response to the CY 2018 PFS proposed rule.
In the CY 2019 PFS proposed rule, we solicited additional comment
regarding the next MP RVU update which must occur by CY 2020.
Specifically, we solicited comment on how we might improve the way that
specialties in the state-level raw rate filings data are crosswalked
for categorization into CMS specialty codes, which are used to develop
the specialty-level risk factors and the MP RVUs.
We received a few comments in response to the comment solicitation,
and we appreciate the commenters' feedback and input. We will consider
the suggestions and information received for future rulemaking, and in
particular for the CY 2020 statutorily required update to MP RVUs.

D. Modernizing Medicare Physician Payment by Recognizing Communication
Technology-Based Services

The health care community uses the term ``telehealth'' broadly to
refer to medical services furnished via communication technology. Under
current PFS payment rules, Medicare routinely pays for many of these
kinds of services. This includes some kinds of remote patient
monitoring (either as separate services or as parts of bundled
services), interpretations of diagnostic tests when furnished remotely
and, under conditions specified in section 1834(m) of the Act, services
that would otherwise be furnished in person but are instead furnished
via real-time, interactive communication technology. Over the past
several years, we have also established several PFS policies to
explicitly pay for non-face-to-face services included as part of
ongoing care management.
Although all of the kinds of services stated above might be called
``telehealth'' by patients, other payers and health care providers, we
have generally used the term ``Medicare telehealth services'' to refer
to the subset of services defined in section 1834(m) of the Act.
Section 1834(m) of the Act defines Medicare telehealth services and
specifies the payment amounts and circumstances under which Medicare
makes payment for a discrete set of services, all of which must
ordinarily be furnished in-person, when they are instead furnished
using interactive, real-time telecommunication technology. Section
1834(m)(4)(F)(i) of the Act enumerates certain Medicare telehealth
services and section 1834(m)(4)(F)(ii) of the Act allows the Secretary
to specify

[[Page 59483]]

additional Medicare telehealth services using an annual process to add
or delete services from the Medicare telehealth list. Section
1834(m)(4)(C) of the Act limits the scope of Medicare telehealth
services for which payment may be made to those furnished to a
beneficiary who is located in certain types of originating sites in
certain, mostly rural, areas. Section 1834(m)(1) of the Act permits
only physicians and certain other types of practitioners to furnish and
be paid for Medicare telehealth services. Although section
1834(m)(4)(F)(ii) of the Act grants the Secretary the authority to add
services to, and delete services from, the list of telehealth services
based on the established annual process, it does not provide any
authority to change the limitations relating to geography, patient
setting, or type of furnishing practitioner because these requirements
are specified in statute. However, we note that sections 50302, 50324,
and 50325 of the Bipartisan Budget Act of 2018 (BBA 18) (Pub. L. 115-
123) have modified or removed the limitations relating to geography and
patient setting for certain telehealth services, including for certain
home dialysis end-stage renal disease-related services, services
furnished by practitioners in certain Accountable Care Organizations,
and acute stroke-related services, respectively.
In the CY 2018 PFS proposed rule (82 FR 53012), we solicited
information from the public regarding ways that we might further expand
access to telehealth services within the current statutory authority
and pay appropriately for services that take full advantage of
communication technologies. Commenters were very supportive of CMS
expanding access to these kinds of services. Many commenters noted that
Medicare payment for telehealth services is restricted by statute, but
encouraged CMS to recognize and support technological developments in
healthcare.
We believe that the provisions in section 1834(m) of the Act apply
particularly to the kinds of professional services explicitly
enumerated in the statutory provisions, like professional
consultations, office visits, and office psychiatry services.
Generally, the services we have added to the telehealth list are
similar to these kinds of services. As has long been the case, certain
other kinds of services that are furnished remotely using
communications technology are not considered ``Medicare telehealth
services'' and are not subject to the restrictions articulated in
section 1834(m) of the Act. This is true for services that were
routinely paid separately prior to the enactment of the provisions in
section 1834(m) of the Act and do not usually include patient
interaction (such as remote interpretation of diagnostic imaging
tests), and for services that were not discretely defined or separately
paid for at the time of enactment and that do include patient
interaction (such as chronic care management services).
As we considered the concerns expressed by commenters about the
statutory restrictions on Medicare telehealth services, we recognized
that the concerns were not limited to the barriers to payment for
remotely furnished services like those described by the office visit
codes. The commenters also expressed concerns pertaining to the
limitations on appropriate payment for evolving physicians' services
that are inherently furnished via communication technology, especially
as technology and its uses have evolved in the decades since the
Medicare telehealth services statutory provision was enacted.
In recent years, we have sought to recognize significant changes in
health care practice, especially innovations in the active management
and ongoing care of chronically ill patients, and have relied on the
medical community to identify and define discrete physicians' services
through the CPT Editorial Panel (82 FR 53163). In response to our
comment solicitation on Medicare telehealth services in the CY 2018 PFS
proposed rule (82 FR 53012), commenters provided many suggestions for
how CMS could expand access to telehealth services within the current
statutory authority and pay appropriately for services that take full
advantage of communication technologies, such as waiving portions of
the statutory restrictions using demonstration authority. After
considering those comments we recognized that concerns regarding the
provisions in section 1834(m) of the Act may have been limiting the
degree to which the medical community developed coding for new kinds of
services that inherently utilize communication technology. We have come
to believe that section 1834(m) of the Act does not apply to all kinds
of physicians' services whereby a medical professional interacts with a
patient via remote communication technology. Instead, we believe that
section 1834(m) of the Act applies to a discrete set of physicians'
services that ordinarily involve, and are defined, coded, and paid for
as if they were furnished during an in-person encounter between a
patient and a health care professional.
For CY 2019, we aimed to increase access for Medicare beneficiaries
to physicians' services that are routinely furnished via communication
technology by clearly recognizing a discrete set of services that are
defined by and inherently involve the use of communication technology.
Accordingly, we made several proposals for modernizing Medicare
physician payment for communication technology-based services,
described below. These services will not be subject to the limitations
on Medicare telehealth services in section 1834(m) of the Act because,
as we have explained, we do not consider them to be Medicare telehealth
services; instead, they will be paid under the PFS like other
physicians' services. Additionally, we note that in furnishing these
services, practitioners need to comply with any applicable privacy and
security laws, including the HIPAA Privacy Rule.
1. Brief Communication Technology-Based Service, e.g. Virtual Check-In
(HCPCS Code G2012)
The traditional office visit codes describe a broad range of
physicians' services. Historically, we have considered any routine non-
face-to-face communication that takes place before or after an in-
person visit to be bundled into the payment for the visit itself. In
recent years, we have recognized payment disparities that arise when
the amount of non-face-to-face work for certain kinds of patients is
disproportionately higher than for others, and created coding and
separate payment to recognize care management services such as chronic
care management and behavioral health integration services (81 FR
80226). We now recognize that advances in communication technology have
changed patients' and practitioners' expectations regarding the
quantity and quality of information that can be conveyed via
communication technology. From the ubiquity of synchronous, audio/video
applications to the increased use of patient-facing health portals, a
broader range of services can be furnished by health care professionals
via communication technology as compared to 20 years ago.
Among these services are the kinds of brief check-in services
furnished using communication technology that are used to evaluate
whether or not an office visit or other service is warranted. When
these kinds of check-in services are furnished prior to an office
visit, then we would currently consider them to be bundled into the
payment for the resulting visit, such as through an evaluation and
management (E/M) visit

[[Page 59484]]

code. However, in cases where the check-in service does not lead to an
office visit, then there is no office visit with which the check-in
service can be bundled. To the extent that these kinds of check-ins
become more effective at addressing patient concerns and needs using
evolving technology, we believe that the overall payment implications
of considering the services to be broadly bundled becomes more
problematic. This is especially true in a resource-based relative value
payment system. Effectively, the better practitioners are in leveraging
technology to furnish effective check-ins that mitigate the need for
potentially unnecessary office visits, the fewer billable services they
furnish. Given the evolving technological landscape, we believe this
creates incentives that are inconsistent with current trends in medical
practice and potentially undermines payment accuracy.
Therefore, we proposed to pay separately, beginning January 1,
2019, for a newly defined type of physicians' service furnished using
communication technology. We stated this service would be billable when
a physician or other qualified health care professional has a brief
non-face-to-face check-in with a patient via communication technology,
to assess whether the patient's condition necessitates an office visit.
We understand that the kind of communication technology used to furnish
these kinds of services has broadened over time and has enhanced the
capacity for medical professionals to care for patients. We solicited
comment on what types of communication technology are utilized by
physicians or other qualified health care professionals in furnishing
these services, including whether audio-only telephone interactions are
sufficient compared to interactions that are enhanced with video or
other kinds of data transmission.
The following discussion summarizes particular definitions and
billing rules for these services, as proposed, and more detailed
comments we received regarding these aspects of the proposal. Our
responses below include information regarding the service definitions
and billing requirements applicable for CY 2019.
Comment: Many commenters supported the proposal to pay for these
kinds of services. Many commenters offered specific suggestions
regarding the service definitions and associated billing rules, which
we describe in detail below. Several commenters urged CMS to take a
cautious approach in paying for these services, given concerns these
commenters stated regarding potential overutilization, while some noted
that potential overutilization would be mitigated by Medicare's
requirements for the visit to be reasonable and medically necessary/
appropriate. Specific aspects of these comments are detailed below.
Response: Based on the broad support for the proposal, we are
creating coding and finalizing our proposal to make separate payment
for this service. We note that in the proposed rule we referred to this
service as HCPCS code GVCI1, which was a placeholder code. The code
will be described as HCPCS code G2012 (Brief communication technology-
based service, e.g. virtual check-in, by a physician or other qualified
health care professional who can report evaluation and management
services, provided to an established patient, not originating from a
related E/M service provided within the previous 7 days nor leading to
an E/M service or procedure within the next 24 hours or soonest
available appointment; 5-10 minutes of medical discussion).
We appreciate commenters' concerns regarding the potential for
overutilization of these services. We plan to monitor utilization with
the intention of determining whether changes, such as a frequency
limitation on the use of this code, are warranted. We would consider
proposing such changes in future rulemaking. We note that, like all
other physicians' services billed under the PFS, each of these services
must be medically reasonable and necessary to be paid by Medicare.
Comment: Many commenters suggested that we not be overly
prescriptive regarding the types of communication technology that are
utilized by physicians or other qualified health care professionals in
furnishing these services. The commenters noted that technology is
evolving at a rapid pace and would require us to have to update our
policies frequently. Several commenters suggested that we permit the
use of email and Electronic Health Record (EHR) patient portals to
qualify. A few commenters stated that audio-visual communication is
ideal. Others acknowledged that not all patients have the same level of
connectivity and therefore recommended allowing audio-only
communication.
Response: We are persuaded by the comments advising us not to be
overly prescriptive about the technology that is used, and are
finalizing allowing audio-only real-time telephone interactions in
addition to synchronous, two-way audio interactions that are enhanced
with video or other kinds of data transmission. We note that telephone
calls that involve only clinical staff could not be billed using HCPCS
code G2012 since the code explicitly describes (and requires) direct
interaction between the patient and the billing practitioner.
We further proposed that in instances when the brief communication
technology-based service originates from a related E/M service provided
within the previous 7 days by the same physician or other qualified
health care professional, that this service would be considered bundled
into that previous E/M service and would not be separately billable,
which is consistent with code descriptor language for CPT code 99441
(Telephone evaluation and management service by a physician or other
qualified health care professional who may report evaluation and
management services provided to an established patient, parent, or
guardian not originating from a related E/M service provided within the
previous 7 days nor leading to an E/M service or procedure within the
next 24 hours or soonest available appointment; 5-10 minutes of medical
discussion), on which this service is partially modeled. We proposed
that in instances when the brief communication technology-based service
leads to an E/M service with the same physician or other qualified
health care professional, this service would be considered bundled into
the pre- or post-visit time of the associated E/M service, and
therefore, would not be separately billable. We also noted that this
service could be used as part of a treatment regimen for opioid use
disorders and other substance use disorders to assess whether the
patient's condition requires an office visit.
We proposed pricing this distinct service at a rate lower than
current E/M in-person visits to reflect the low work time and intensity
and to account for the resource costs and efficiencies associated with
the use of communication technology. We expect that these services will
be initiated by the patient, especially since many beneficiaries would
be financially liable for sharing in the cost of these services. For
the same reason, we believe it is important for patients to consent to
receiving these services. Therefore, we specifically solicited comment
on whether we should require, for example, verbal consent that will be
noted in the medical record for each service.
Comment: Many commenters stated that it would be burdensome to
obtain consent from the patient prior to each occurrence of this
service. Some commenters suggested that the patient be informed through
the use of a service agreement which could be signed once and kept on
file. Several commenters

[[Page 59485]]

expressed concern about the cost to beneficiaries, especially since
they may have previously received this service without financial
liability, and therefore recommended requiring verbal consent that is
documented in the medical record.
Response: We understand the potential burden regarding obtaining
consent for each occurrence of this service. However, we are persuaded
by those commenters who suggest that unexpected cost to beneficiaries
would be particularly problematic. We note that under our current
policy for several types of care management services, verbal consent is
required to be obtained and documented in the medical record. The
consent policy was implemented, in part, based on feedback we received
from practitioners reporting the care management services, to alleviate
burdens of alternative approaches, such as requirements for written
consent or completion of particular forms. Consequently, we believe the
same requirement could be applied here, without imposition of
significant burden. We are finalizing requiring verbal consent that is
noted in the medical record for each billed service.
We also proposed that this service can only be furnished for
established patients because we believe that the practitioner needs to
have an existing relationship with the patient, and therefore, basic
knowledge of the patient's medical condition and needs, in order to
perform this service.
Comment: Many commenters were supportive of our proposal to limit
this service to established patients, while several commenters noted
that there would be instances when it would be appropriate to bill this
service for new patients. MedPAC noted particular concern regarding
potential increases in volume that are not related to ongoing, informed
patient care. A few commenters requested that CMS clarify that
established patients include those patients who have been seen by a
practitioner within the same group practice.
Response: After considering the comments, we are finalizing our
proposal to limit this service to established patients, given the
concern expressed by commenters regarding the degree to which these
services can be furnished without familiarity and experience with
individual patients, and in light of MedPAC's concerns regarding
increases in utilization that are not related to ongoing, informed
patient care. In response to the request for clarification about what
constitutes an established patient, we defer to CPT's definition of
this term. CPT defines an established patient as one who has received
professional services from the physician or qualified health care
professional or another physician or qualified health care professional
of the exact same specialty and subspecialty who belongs to the same
group practice, within the past 3 years. We also emphasize that payment
for this service would not preclude a physician or other qualified
health care professional from having communication via phone or other
modalities with any patient, new or existing, for a variety of reasons.
We believe that much of the pre- and post- work associated with, and
included in the valuation of existing in-person services that are paid
under the PFS can include some types of interactions with patients that
are not in-person.
We did not propose to apply a frequency limit on the use of this
code by the same practitioner with the same patient, but we want to
ensure that this code is appropriately utilized for circumstances when
a patient needs a brief non-face-to-face check-in to assess whether an
office visit is necessary. We solicited comment on whether it would be
clinically appropriate to apply a frequency limitation on the use of
this code by the same practitioner with the same patient, and on what
would be a reasonable frequency limitation.
Comment: Many commenters were opposed to creating a frequency
limitation, suggesting we wait and monitor utilization. Others noted
that it could be clinically appropriate to utilize this service
multiple times in a week. A few commenters stated that this service
could be utilized in behavioral health treatment, and cited an example
of assessing suicidal risk, in which case they suggested the frequency
should not be limited since routine virtual check-ins would be
clinically warranted in some cases. Some commenters suggested a
frequency limit of three times per week whereas others suggested a
limit of once per week.
Response: After considering these comments, we are not implementing
a frequency limitation for CY 2019. However, we plan to monitor
utilization with the intention of determining whether such a limitation
is warranted. In that case, we would consider proposing a limitation in
future rulemaking. We note that, like all other physicians' services
billed under the PFS, each of these services must be medically
reasonable and necessary to be paid by Medicare.
We also solicited comment on the timeframes under which this
service would be separately billable compared to when it would be
bundled. We believe the general construct of bundling the services that
lead directly to a billable visit is important, but we are concerned
that establishing strict timeframes may create unintended consequences
regarding scheduling of care. For example, we do not want to bundle
only the services that occur within 24 hours of a visit only to see a
significant number of visits occurring at 25 hours after the initial
service. In order to mitigate these incentives, we solicited comment on
whether we should consider broadening the window of time and/or
circumstances in which this service should be bundled into the
subsequent related visit. We noted that these services, like any other
physicians' service, must be medically reasonable and necessary in
order to be paid by Medicare.
Comment: Several commenters suggested that we remove the language
in the code descriptor that states ``or soonest available
appointment.'' A few commenters suggested we extend the timeframe to 48
hours following the virtual check-in, while others suggested it would
be reasonable to expand the limit to 14 days before and 72 hours after
the service. Several commenters stated concerns that it might be
difficult to document that a subsequent visit was not the ``soonest
available appointment.'' Several commenters expressed concern about the
potential for overutilization of this code.
Response: We agree with commenters that urged caution regarding
overutilization of this service and believe that the language stating,
`or soonest available appointment' in the code description may serve to
reduce potential perverse payment incentives to delay seeing patients
to ensure payment for this code. We appreciate the concerns regarding
potential difficulty in proving that a particular visit was not the
``soonest available.'' We agree that in each individual case, it might
be challenging to prove whether or not other appointments were
available prior to the visit, especially since beneficiary convenience
is also presumably a factor for when appointments are scheduled.
However, we believe that, as written, the code description could help
to guard against the potential for abuse that would be present if we
instead adopted a purely time-based window for bundling of this
service. We also believe that ``soonest available appointment'' might
allow for clinically appropriate flexibility. Therefore, after
consideration of the public comments, we are finalizing the code
descriptor for HCPCS code G2012 as proposed. However, we plan to
monitor this service with the intention of determining whether changes
are

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necessary to the timeframes under which this service would be
separately billable compared to when it would be bundled. We would
consider any such changes in future rulemaking.
We solicited comment on how clinicians could best document the
medical necessity of this service, consistent with documentation
requirements necessary to demonstrate the medical necessity of any
service under the PFS.
Comment: A few commenters stated that documentation for this
service should be consistent with the requirements for an in-person
encounter and requested appropriate documentation requirements to
ensure that the check-in is fully incorporated into the individual's
medical history. Other commenters urged us not to be overly
prescriptive.
Response: We appreciate the commenters' input. We do not want to
impose undue administrative burden likely to discourage appropriate
provision of these services, and are therefore not requiring any
service-specific documentation requirements for this service. We note
again that these services, like any other physicians' service, must be
medically reasonable and necessary in order to be paid by Medicare.
Comment: Several commenters stated that the proposed payment rate
would be inadequate for modalities that are both audio- and visual-
capable, whereas others stated that the proposed valuation was
appropriate. One commenter suggested we create a second code for a
virtual check-in that only utilizes synchronous audio/video technology,
with a higher reimbursement rate associated with the increased
complexity of technology.
Response: As discussed in section II.H of this final rule, we are
finalizing the valuation for HCPCS code G2012 as proposed. We believe
this valuation reflects the work time and intensity of the service
relative to other PFS services and accounts for the resource costs and
efficiencies associated with the use of communication technology. We
recognize that the valuation of this service is relatively modest,
especially compared to in-person services, however, we believe that the
proposed valuation accurately reflects the resources involved in
furnishing this service. We plan to monitor the utilization of this
code and note that we routinely address recommended changes in values
for codes paid under the PFS.
Comment: A few commenters requested that CMS allow licensed
physical therapists to furnish these services. Additionally, a few
commenters requested that we allow other clinical staff, such as
registered nurses, to furnish this service.
Response: We are finalizing maintaining this code as part of the
set of codes that is only reportable by those that can furnish E/M
services. We believe this is appropriate since the service describes a
check-in directly with the billing practitioner to assess whether an
office visit is needed. We agree that similar check-ins provided by
nurses and other clinical staff can be important aspects of coordinated
patient care. We note that these kinds of non-face-to-face services by
other medical professionals and clinical staff continue to be included
in the RVUs for other codes, including those that describe E/M visits,
and for procedures with global periods. We also note that non-face-to-
face services provided by clinical staff can be explicitly and
separately paid for as part of several care management services, many
of which we have introduced over the past several years. However, this
service is meant to describe, and account for the resources involved,
when the billing practitioner directly furnishes the virtual check-in.
Comment: Several commenters requested that CMS waive the
beneficiary co-payment for this service.
Response: We appreciate the commenters' request; however, we do not
have the statutory authority to make specific changes to the
requirements regarding beneficiary cost sharing for this service.
In summary, we are creating coding and finalizing our proposal to
make separate payment for brief communication technology-based
services. The code will be described as G2012 (Brief communication
technology-based service, e.g. virtual check-in, by a physician or
other qualified health care professional who can report evaluation and
management services, provided to an established patient, not
originating from a related E/M service provided within the previous 7
days nor leading to an E/M service or procedure within the next 24
hours or soonest available appointment; 5-10 minutes of medical
discussion). We are finalizing allowing real-time audio-only telephone
interactions in addition to synchronous, two-way audio interactions
that are enhanced with video or other kinds of data transmission. We
are finalizing our proposal to limit this service to established
patients.
We are finalizing that if the service originates from a related E/M
service provided within the previous 7 days by the same physician or
other qualified health care professional, that this service would be
considered bundled into that previous E/M service and would not be
separately billable. In instances when the service leads to an E/M
service with the same physician or other qualified health care
professional, we are finalizing that this service would be considered
bundled into the pre- or post-visit time of the associated E/M service,
and therefore, would not be separately billable. We plan to monitor
this service with the intention of determining whether changes are
necessary to the timeframes under which this service would be
separately billable compared to when it would be bundled. We would
consider any such changes in future rulemaking.
We are finalizing requiring verbal consent from beneficiaries that
is noted in the medical record for each service. We are not
implementing a frequency limitation for CY 2019, however, we plan to
monitor utilization with the intention of determining whether such a
limitation is warranted. In that case, we would consider that for
future rulemaking.
We are finalizing the valuation for HCPCS code G2012 as proposed.
We will monitor the utilization of this code and consider any potential
adjustments to billing rules or valuation for this service through
future rulemaking. We note that cost sharing for these services will
apply.
For details related to developing utilization estimates for this
service, see section VII. of this final rule, Regulatory Impact
Analysis. For additional details related to valuation of this service,
see section II.H. of this final rule, Valuation of Specific Codes.
2. Remote Evaluation of Pre-Recorded Patient Information (HCPCS Code
G2010)
Stakeholders have requested that CMS make separate Medicare payment
when a physician uses recorded video and/or images captured by a
patient in order to evaluate a patient's condition. These services
involve what is referred to under section 1834(m) of the Act as
``store-and-forward'' communication technology that provides for the
``asynchronous transmission of health care information.'' We noted in
the proposed rule that we believe these services involve pre-recorded
patient-generated still or video images. Other types of patient-
generated information, such as information from heart rate monitors or
other devices that collect patient health marker data, could
potentially be reported with CPT codes that describe remote patient
monitoring (83 FR 35724). Under section 1834(m) of

[[Page 59487]]

the Act, payment for telehealth services furnished using such store-
and-forward technology is permitted only under federal telemedicine
demonstration programs conducted in Alaska or Hawaii, and these
telehealth services remain subject to the other statutory restrictions
governing Medicare telehealth services. However, much like the brief
communication technology-based service (``virtual check-in service'')
that we are finalizing in this rule as described previously, this
remote evaluation service would not be a substitute for an in-person
service currently separately payable under the PFS. As such, this
remote evaluation service is distinct from the telehealth services
described under section 1834(m) of the Act. Effective January 1, 2019,
we proposed to create specific coding that describes the remote
professional evaluation of patient-transmitted information conducted
via pre-recorded ``store and forward'' video or image technology.
Because this service would not be considered a Medicare telehealth
service, it would not be subject to the geographic and other
restrictions on telehealth services under section 1834(m) of the Act;
and the proposed valuation reflects the resource costs associated with
furnishing services utilizing communication technology.
Also like the virtual check-in service we are finalizing as
described previously, this service would be used to determine whether
or not an office visit or other service is warranted. When the remote
evaluation of pre-recorded patient-submitted images and/or video
results in an in-person E/M office visit with the same physician or
qualified health care professional, we proposed that this remote
service will be considered bundled into that office visit and therefore
not be separately billable. We further proposed that in instances when
the remote service originates from a related E/M service provided
within the previous 7 days by the same physician or qualified health
care professional that this service will be considered bundled into
that previous E/M service and not be separately billable. In summary,
we proposed this service to be a stand-alone service that could be
separately billed to the extent that there is no resulting E/M office
visit and there is no related E/M office visit within the previous 7
days of the remote service being furnished. We believe the coding and
separate payment for this service is consistent with the progression of
technology and its impact on the practice of medicine in recent years,
and would result in increased access to services for Medicare
beneficiaries. We note that in the proposed rule we referred to this
service as HCPCS code GRAS1, which was a placeholder code. The code for
this service is G2010 (Remote evaluation of recorded video and/or
images submitted by an established patient (e.g., store and forward),
including interpretation with follow-up with the patient within 24
business hours, not originating from a related E/M service provided
within the previous 7 days nor leading to an E/M service or procedure
within the next 24 hours or soonest available appointment). We
solicited comment as to whether these services should be limited to
established patients; or whether there are certain cases, like
dermatological or ophthalmological services, where it might be
appropriate for a new patient to receive these services. For example,
when a patient seeks care for a specific skin condition from a
dermatologist with whom she does not have a prior relationship, and
part of the inquiry is an assessment of whether the patient needs an
in-person visit, the patient could share, and the dermatologist could
remotely evaluate, pre-recorded information. We also noted that this
service is distinct from the virtual check-in service described
previously in that this service involves the practitioner's evaluation
of a patient-generated still or video image transmitted by the patient,
and the subsequent communication of the practitioner's response to the
patient; while the virtual check-in service describes a service that
occurs in real time and does not involve the asynchronous transmission
of any recorded image.
The following discussion summarizes particular definitions and
billing rules we proposed for this service and the more detailed
comments we received regarding these aspects of the proposal. Our
responses below include information regarding the service definitions
and billing requirements applicable for 2019. We additionally address
comments we received regarding whether these services should be limited
to established patients; or whether there are certain cases, like
dermatological or ophthalmological services, where it might be
appropriate for a new patient to receive these services.
Comment: Several commenters were supportive of the proposal to pay
for these kinds of services. Several commenters urged CMS to take a
cautious approach in paying for these services, given concerns these
commenters expressed regarding potential overutilization.
Response: We appreciate the many thoughtful comments regarding this
proposal. Based on our review of the comments received, especially the
broad support for the proposal, we are creating coding and finalizing
our proposal to make separate payment for this service. The code will
be described as G2010 (Remote evaluation of recorded video and/or
images submitted by an established patient (e.g., store and forward),
including interpretation with follow-up with the patient within 24
business hours, not originating from a related E/M service provided
within the previous 7 days nor leading to an E/M service or procedure
within the next 24 hours or soonest available appointment).
We appreciate commenters' concerns regarding the potential for
overutilization of these services. We plan to monitor utilization. We
note that, like all other physicians' services billed under the PFS,
each of these services must be medically reasonable and necessary to be
paid by Medicare.
Comment: Many commenters supported allowing this service to be
furnished to new patients, noting that an established relationship is
not required for the practitioner to remotely evaluate an image or
video to consider whether an office visit or other service is
warranted, particularly in dermatology and ophthalmology. One commenter
stated that allowing new patients to receive this service would also be
of value in urology, as it would provide a way to assess patients with
conditions such as hematuria (that is, blood in the urine) in a timely
manner. The AMA and other commenters urged CMS to limit these services
to established patients. The AMA also suggested that, at some point
before a physician or practitioner furnishes a virtual service, the
clinician (or another clinician with whom the furnishing clinician has
a cross-coverage agreement in place) should conduct a face-to-face
examination (either in-person or via telehealth) with the patient,
noting that the existence of a valid patient-physician relationship
ensures that the treating physician or qualified health professional
meets a threshold standard of care, enhances care coordination/
continuity of care, and ensures that patients are afforded advance
notice of when the relationship is being established and that such a
patient-initiated service may result in out-of-pocket expenses
including deductibles and co-insurance, and additionally serves to
minimize the potential for program integrity concerns.
Response: We are persuaded by comments urging us to permit separate

[[Page 59488]]

payment for these services only for established patients. Since this
service is furnished directly by the billing practitioner, we believe
it should be furnished in the context of an existing patient-clinician
relationship. Therefore, we are finalizing the reporting and billing of
HCPCS code G2010 only for established patients.
Comment: Many commenters stated that it would be burdensome to
obtain consent from the patient prior to each occurrence of this
service. Some commenters suggested that the patient could be informed
through the use of a service agreement which could be signed once and
kept on file. Several commenters expressed concern about the cost to
beneficiaries and therefore recommended requiring verbal consent that
is documented in the medical record.
Response: As noted previously regarding HCPCS code G2012, we
believe it is important for patients to consent to receive these
services, especially since many beneficiaries would be financially
liable for sharing in the cost of these services. We understand the
potential burden regarding obtaining consent for each occurrence of
this service. However, we are persuaded by those commenters who suggest
that unexpected cost to beneficiaries would be particularly
problematic. We are finalizing requiring beneficiary consent that could
be verbal or written, including electronic confirmation that is noted
in the medical record for each billed service for HCPCS code G2010.
We acknowledge that verbal consent could be obtained using more
than one communication modality, especially since this service is
initiated by the patient and involves submission of an image or video.
Therefore, we do not intend to include the word ``verbal'' in the
descriptor for the code that describes this services, since ``verbal''
could imply written or electronic consent.
Comment: Several commenters stated that the proposed payment rate
is too low, citing that it is below market compared to the rate many
asynchronous telemedicine companies pay their contracted/employed
physician staff, and noted that new patients in particular require more
resources, whereas others stated that the proposed valuation was
appropriate. One commenter suggested that CMS should encourage
clinicians to recommend that patients have virtual or in-person visits
if the clinician has concerns about the quality of the pre-recorded
patient information, such as still or video images.
Response: As discussed in section II.H. of this final rule, we are
finalizing the valuation for HCPCS code G2010 as proposed. As stated
previously regarding the valuation of the brief communication
technology-based service code, HCPCS code G2012, we believe that the
proposed valuation accurately reflects the resources involved in
furnishing this service. We will monitor the utilization of this code
and consider any potential adjustments to billing rules or valuation
for this service through future rulemaking.
Comment: A few commenters requested that CMS clarify that the
``verbal follow-up'' that occurs after the billing practitioner
evaluates the images or video submitted by the patient may take place
via any mode of communication, including secure text messaging, phone
call, or live/asynchronous video chat, so as not to restrict a
clinician's interaction with patients. One commenter suggested that CMS
should encourage clinicians to recommend that patients have a face-to-
face visit (in-person or via telehealth) if the clinician has concerns
about the quality of the pre-recorded patient information, such as
still or video images.
Response: We are finalizing that the follow-up could take place via
phone call, audio/video communication, secure text messaging, email, or
patient portal communication and note that accordingly, we do not
intend to include the word ``verbal'' in the code descriptor. We note
that any such communications must be compliant with HIPAA and other
relevant laws. Additionally, we agree that in instances in which the
quality of the pre-recorded information submitted by a patient is
insufficient for the clinician to assess whether an office visit or
other medical service is warranted, the clinician could not fully
furnish a remote evaluation service and, therefore, could not bill for
the service. We anticipate that in such a circumstance, the clinician
would attempt other methods of communication with the patient to either
obtain sufficient images to enable a remote evaluation service or
suggest other appropriate alternatives.
Comment: Several commenters suggested that we remove the language
in the code descriptor for this service that states ``or soonest
available appointment,'' and stated that it might be difficult to
document that a subsequent visit was not the ``soonest available
appointment.''
Response: As noted previously regarding similar comments on HCPCS
code G2012, we appreciate the concerns regarding potential difficulty
in proving that a particular visit was not the ``soonest available.''
We agree that in each individual case, it might be challenging to prove
whether or not other appointments were available prior to the visit,
especially since beneficiary convenience is also presumably a factor in
when appointments are scheduled. However, we believe that, as written,
the code description would guard against the potential for abuse that
would be present if we instead adopted a purely time-based window for
bundling of this service. Therefore, in response to the comments, we
are finalizing retaining this language in the code descriptor for HCPCS
code G2010 as proposed. However, we plan to monitor this service with
the intention of determining if changes are necessary to the timeframes
under which this service would be separately billable compared to when
it would be bundled. We would consider any such changes in future
rulemaking.
Comment: A few commenters suggested that CMS consider inclusion of
email/messaging or questionnaires/assessments that do not include an
image or other visual item in the scope of this code.
Response: The scope of this service is limited to the evaluation of
pre-recorded video and/or images. We note that there is separate coding
under the PFS for several types of formal assessments, such as CPT code
96160 (Administration of patient-focused health risk assessment
instrument (e.g., health hazard appraisal) with scoring and
documentation, per standardized instrument), many of which can be
reported when the form is completed by the patient and submitted using
remote communication technology for subsequent evaluation by the
clinician. Additionally, behavioral health assessments are included in
coding and payment for the behavioral health integration services that
were finalized for separate payment beginning in CY 2017.
In summary, we are creating coding and finalizing our proposal to
make separate payment for remote evaluation of recorded video and/or
images submitted by the patient. The code will be described as G2010
(Remote evaluation of recorded video and/or images submitted by an
established patient (e.g., store and forward), including interpretation
with follow-up with the patient within 24 business hours, not
originating from a related E/M service provided within the previous 7
days nor leading to an E/M service or procedure within the next 24
hours or soonest available appointment). We are finalizing that

[[Page 59489]]

HCPCS code G2010 may be billed only for established patients. We are
finalizing that the follow-up with the patient could take place via
phone call, audio/video communication, secure text messaging, email, or
patient portal communication.
When the review of the patient-submitted image and/or video results
in an in-person E/M office visit with the same physician or qualified
health care professional, we are finalizing that this remote service
will be considered bundled into that office visit and therefore will
not be separately billable. We are further finalizing that in instances
when the remote service originates from a related E/M service provided
within the previous 7 days by the same physician or qualified health
care professional that this service will be considered bundled into
that previous E/M service and also will not be separately billable.
We are finalizing requiring beneficiary consent that could be
verbal or written, including electronic confirmation that is noted in
the medical record for each billed service for HCPCS code G2010.
We are finalizing the valuation for HCPCS code G2010 as proposed.
We will monitor utilization of this code and consider any potential
adjustments to billing rules or valuation of this service through
future rulemaking. We note that cost sharing for these services will
apply.
For details related to our utilization estimates for this service,
see section VII. of this final rule, Regulatory Impact Analysis. For
further discussion related to valuation of this service, please see the
section II.H. of this final rule, Valuation of Specific Codes.
3. Interprofessional Internet Consultation (CPT Codes 99451, 99452,
99446, 99447, 99448, and 99449)
As part of our standard rulemaking process, we received
recommendations from the RUC to assist in establishing values for six
CPT codes that describe interprofessional consultations. In 2013, CMS
received recommendations from the RUC for CPT codes 99446
(Interprofessional telephone/internet assessment and management service
provided by a consultative physician including a verbal and written
report to the patient's treating/requesting physician or other
qualified health care professional; 5-10 minutes of medical
consultative discussion and review), 99447 (Interprofessional
telephone/internet assessment and management service provided by a
consultative physician including a verbal and written report to the
patient's treating/requesting physician or other qualified health care
professional; 11-20 minutes of medical consultative discussion and
review), 99448 (Interprofessional telephone/internet assessment and
management service provided by a consultative physician including a
verbal and written report to the patient's treating/requesting
physician or other qualified health care professional; 21-30 minutes of
medical consultative discussion and review), and 99449
(Interprofessional telephone/internet assessment and management service
provided by a consultative physician including a verbal and written
report to the patient's treating/requesting physician or other
qualified health care professional; 31 minutes or more of medical
consultative discussion and review). CMS declined to adopt these codes
for separate payment, stating in the CY 2014 PFS final rule with
comment period that these kinds of services are considered bundled (78
FR 74343). For CY 2019, the CPT Editorial Panel created two new codes
to describe additional consultative services, including a code
describing the work of the treating physician when initiating a
consult, and the RUC recommended valuation for new codes, CPT codes
99452 (Interprofessional telephone/internet/electronic health record
referral service(s) provided by a treating/requesting physician or
qualified health care professional, 30 minutes) and 99451
(Interprofessional telephone/internet/electronic health record
assessment and management service provided by a consultative physician
including a written report to the patient's treating/requesting
physician or other qualified health care professional, 5 or more
minutes of medical consultative time). The RUC also reaffirmed their
prior recommendations for the existing CPT codes. The six codes
describe assessment and management services conducted through
telephone, internet, or electronic health record consultations
furnished when a patient's treating physician or other qualified
healthcare professional requests the opinion and/or treatment advice of
a consulting physician or qualified healthcare professional with
specific specialty expertise to assist with the diagnosis and/or
management of the patient's problem without the need for the patient's
face-to-face contact with the consulting physician or qualified
healthcare professional. Currently, the resource costs associated with
seeking or providing such a consultation are considered bundled, which
in practical terms means that specialist input is often sought through
scheduling a separate visit for the patient when a phone or internet-
based interaction between the treating practitioner and the consulting
practitioner would have been sufficient. We believe that proposing
payment for these interprofessional consultations performed via
communications technology such as telephone or internet is consistent
with our ongoing efforts to recognize and reflect medical practice
trends in primary care and patient-centered care management within the
PFS.
Beginning in the CY 2012 PFS proposed rule (76 FR 42793), we have
recognized the changing focus in medical practice toward managing
patients' chronic conditions, many of which particularly challenge the
Medicare population, including heart disease, diabetes, respiratory
disease, breast cancer, allergies, Alzheimer's disease, and factors
associated with obesity. We have expressed concerns that the current E/
M coding does not adequately reflect the changes that have occurred in
medical practice, and the activities and resource costs associated with
the treatment of these complex patients in the primary care setting. In
the years since 2012, we have acknowledged the shift in medical
practice away from an episodic treatment-based approach to one that
involves comprehensive patient-centered care management, and have taken
steps through rulemaking to better reflect that approach in payment
under the PFS. In CY 2013, we established new codes to pay separately
for transitional care management (TCM) services. Next, we finalized new
coding and separate payment beginning in CY 2015 for chronic care
management (CCM) services provided by clinical staff (81 FR 80226). In
the CY 2017 PFS final rule, we established separate payment for complex
CCM services, an add-on code to the visit during which CCM is initiated
to reflect the work of the billing practitioner in assessing the
beneficiary and establishing the CCM care plan, and established
separate payment for Behavioral Health Integration (BHI) services (81
FR 80226 through 80227).
As part of this shift in medical practice, and with the
proliferation of team-based approaches to care that are often
facilitated by electronic medical record technology, we believe that
making separate payment for interprofessional consultations undertaken
for the benefit of treating a patient will contribute to payment
accuracy for primary care and care management services. We proposed

[[Page 59490]]

separate payment for these services, discussed in section II.H. of this
final rule, Valuation of Specific Codes.
Although we proposed to make separate payment for these services
because we believe they describe resource costs directly associated
with seeking a consultation for the benefit of the beneficiary, we do
have concerns about how these services can be distinguished from
activities undertaken for the benefit of the practitioner, such as
information shared as a professional courtesy or as continuing
education. We do not believe that those examples will constitute a
service directly attributable to a single Medicare beneficiary, and
therefore neither the Medicare program nor the beneficiary should be
responsible for those costs. We therefore solicited comment on our
assumption that these are separately identifiable services, and the
extent to which they can be distinguished from similar services that
are nonetheless primarily for the benefit of the practitioner. We noted
that there are program integrity concerns around making separate
payment for these interprofessional consultation services, including
around CMS's or its contractors' ability to evaluate whether an
interprofessional consultation is reasonable and necessary under the
particular circumstances. As the beneficiary would be liable for any
cost sharing associated with these services, we also sought comment on
the necessity of requiring patient consent for these, and whether than
consent should be written or verbal. We solicited comment on how best
to minimize potential program integrity issues, and noted we were
particularly interested in information on whether these types of
services are paid separately by private payers and if so, what controls
or limitations private payers have put in place to ensure these
services are billed appropriately.
The following is a summary of the comments we received regarding
how best to minimize potential program integrity issues.
Comment: Almost all commenters were very supportive of CMS
proposing separate payment for these services. Commenters pointed out
that these are discrete physician services undertaken for the benefit
of the patient, and easily distinguished from consultations undertaken
for the edification of the practitioner. One commenter stated as
medical care moves toward more comprehensive patient-centered care
management, frequent consultation with multiple specialists is
necessary. Under the current model this means separate visits for the
patients that are costly and inconvenient. Internet-based consultations
between the treating practitioner and the consulting specialists
provide appropriate, convenient and cost effective alternatives.
Commenters were clear that, by not making separate payment for these
services, CMS would not be accurately paying for the work of both the
treating and consulting physicians in a consultative scenario.
Many commenters provided helpful responses to CMS' request for
information on how to minimize program integrity concerns for these
services. A few commenters provided suggestions as to how CMS could
verify the medical necessity of the consultation, including verifying
that the treating and consulting physician were of different medical
specialties, requiring patient identifiers and documentation of how the
interaction improved patient care, defining a time period under which
an E/M visit and an Interprofessional Consultation cannot both be
billed for the same diagnosis, and creating frequency limitations on
billing. Others suggested that the treating physician must document
that they acted on the recommendation of the consulting physician prior
to billing for CPT code 99452. Commenters had a number of suggestions
for items that CMS should require, including that Interprofessional
Consultations should consist of focused questions that are answerable
solely from information in the EMR; that they be answered in 3 business
days; and that the consulting physician should restate the question in
their response, provide recommendations for evaluation, management,
and/or ongoing monitoring, provide a rationale for recommendations, and
provide recommendations for contingencies. Other commenters suggested
that CMS could make separate payment contingent upon whether the
underlying condition was urgent or related to critical care and that
the consultation helped avoid transfer or interruption of care or that
internal expertise was sought and was not available. Many commenters
also encouraged CMS to avoid imposing overly restrictive documentation
requirements. One commenter stated that, due to potential program
integrity concerns, these services should be subject to the Medicare
telehealth restrictions on beneficiary location and site of service.
Another commenter recommended that CMS delay implementation until the
program integrity concerns have been addressed. Other commenters
encouraged CMS to monitor utilization for abuse.
Response: We thank commenters for their support and additional
information on the ways in which these services are distinct physician
services. We note that because these services are inherently non face-
to-face (the patient need not be present in order for the service to be
furnished in its entirety), they would not be considered as potential
Medicare telehealth services under section 1834(m) of the Act. We
appreciate the wealth of information and suggestions from commenters;
however, we also agree with the many commenters who pointed out that
adding many additional billing requirements may inhibit uptake for
these services. As we note below, we are requiring documentation of
verbal patient consent to receive these services, and are adopting
existing CPT prefatory language. We plan to monitor utilization of
these services and will consider making refinements to billing rules,
documentation requirements or claims edits, including those suggested
by commenters, through future rulemaking as necessary.
Comment: Many commenters suggested that CMS limit or eliminate
beneficiary cost sharing for these services to obviate the question of
patient consent entirely.
Response: Under current statute, we do not have the authority to
change the requirements for the beneficiary cost sharing for these
services.
Additionally, since these codes describe services that are
furnished without the beneficiary being present, we proposed to require
the treating practitioner to obtain verbal beneficiary consent in
advance of these services, which would be documented by the treating
practitioner in the patient's medical record, similar to the conditions
of payment associated with separately billable care management services
under the PFS. Obtaining advance beneficiary consent includes ensuring
that the patient is aware of applicable cost sharing.
The following is a summary of the comments we received regarding
whether to require the treating practitioner to obtain verbal
beneficiary consent in advance of these services, which would be
documented by the treating practitioner in the medical record similar
to the conditions of payment associated with the care management
services under the PFS, as well as comments on other aspects of this
proposal.
Comment: Many commenters stated that verbal patient consent was an
appropriate safeguard against unnecessary utilization, while others
disagreed, stating that the requirement

[[Page 59491]]

to obtain consent may cause unnecessary burden in cases where the
patient is unresponsive or the need for the interprofessional
consultation is urgent such as in a critical care or emergency setting.
Other commenters stated that a single blanket patient consent to
receive interprofessional consultation services would be preferable to
minimize the need to obtain consent for each of what may be multiple
consultations. One commenter questioned whether the consulting
physician would need to verify that the beneficiary had consented,
given that only the treating physician is in contact with the
beneficiary.
Response: We understand the potential burden regarding obtaining
consent. However, we believe that it is important for beneficiaries to
consent to the service and thus be notified of their cost-sharing
obligations. We note that under our current policy for several care
management services, consent is required to be documented in the
medical record. That policy was implemented, in part, based on feedback
we received from practitioners reporting the care management services,
to alleviate burdens of alternative approaches. Consequently, we
believe the same requirement could be applied here, without imposition
of significant burden.
We are finalizing that the patient's verbal consent is required,
and that consent must be noted in the medical record for each service,
consistent with the policy we are finalizing for the brief
communication technology-based services (HCPCS code G2012) as noted
above, as well as with the patient consent policies in place for care
management services, under the PFS.
Comment: Commenters requested that CMS clarify whether billing for
these services is limited to physicians or if other healthcare
practitioners, such as nurses or physical therapists, may bill for
these services as well.
Response: We appreciate commenters' request for clarification. We
believe that billing of these services should be limited to those
practitioners that can independently bill Medicare for E/M visits, as
interprofessional consultations are primarily for the ongoing
evaluation and management of the patient, including collaborative
medical decision making among practitioners. We are therefore not
finalizing any expansion of these services beyond their current scope.
Comment: A few commenters requested that CMS adopt CPT prefatory
language for these services as is CMS' longstanding practice when
adopting most new CPT coding.
Response: We agree with the commenters and confirm that we will be
adopting existing CPT prefatory language regarding these services.
In summary, we are finalizing separate payment for CPT codes 99451,
99452, 99446, 99447, 99448, and 99449 describing Interprofessional
consultations. We are finalizing a policy to require the patient's
verbal consent that is noted in the medical record for each
interprofessional consultation service. We note that cost sharing will
apply for these services. These interprofessional services may be
billed only by practitioners that can bill Medicare independently for
E/M services.
For further discussion related to the valuation of these services,
please see section II.H. of this final rule, Valuation of Specific
Codes.
4. Medicare Telehealth Services Under Section 1834(m) of the Act
a. Billing and Payment for Medicare Telehealth Services Under Section
1834(m) of the Act
As discussed in this rule and in prior rulemaking, several
conditions must be met for Medicare to make payment for telehealth
services under the PFS. For further details, see the full discussion of
the scope of Medicare telehealth services in the CY 2018 PFS final rule
(82 FR 53006).
b. Adding Services to the List of Medicare Telehealth Services
In the CY 2003 PFS final rule with comment period (67 FR 79988), we
established a process for adding services to or deleting services from
the list of Medicare telehealth services in accordance with section
1834(m)(4)(F)(ii) of the Act. This process provides the public with an
ongoing opportunity to submit requests for adding services, which are
then reviewed by us. Under this process, we assign any submitted
request to add to the list of telehealth services to one of the
following two categories:
Category 1: Services that are similar to professional
consultations, office visits, and office psychiatry services that are
currently on the list of telehealth services. In reviewing these
requests, we look for similarities between the requested and existing
telehealth services for the roles of, and interactions among, the
beneficiary, the physician (or other practitioner) at the distant site
and, if necessary, the telepresenter, a practitioner who is present
with the beneficiary in the originating site. We also look for
similarities in the telecommunications system used to deliver the
service; for example, the use of interactive audio and video equipment.
Category 2: Services that are not similar to those on the
current list of telehealth services. Our review of these requests
includes an assessment of whether the service is accurately described
by the corresponding code when furnished via telehealth and whether the
use of a telecommunications system to furnish the service produces
demonstrated clinical benefit to the patient. Submitted evidence should
include both a description of relevant clinical studies that
demonstrate the service furnished by telehealth to a Medicare
beneficiary improves the diagnosis or treatment of an illness or injury
or improves the functioning of a malformed body part, including dates
and findings, and a list and copies of published peer reviewed articles
relevant to the service when furnished via telehealth. Our evidentiary
standard of clinical benefit does not include minor or incidental
benefits.
Some examples of clinical benefit include the following:
Ability to diagnose a medical condition in a patient
population without access to clinically appropriate in-person
diagnostic services.
Treatment option for a patient population without access
to clinically appropriate in-person treatment options.
Reduced rate of complications.
Decreased rate of subsequent diagnostic or therapeutic
interventions (for example, due to reduced rate of recurrence of the
disease process).
Decreased number of future hospitalizations or physician
visits.
More rapid beneficial resolution of the disease process
treatment.
Decreased pain, bleeding, or other quantifiable symptom.
Reduced recovery time.
The list of telehealth services, including the proposed additions
described later in this section, is included in the Downloads section
to this proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-
Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
Historically, requests to add services to the list of Medicare
telehealth services had to be submitted and received no later than
December 31 of each calendar year to be considered for the next
rulemaking cycle. However, for CY 2019 and onward, we intend to accept
requests through February 10, consistent with the deadline for our
receipt of code valuation recommendations from the RUC. To be

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considered during PFS rulemaking for CY 2020, requests to add services
to the list of Medicare telehealth services must be submitted and
received by February 10, 2019. Each request to add a service to the
list of Medicare telehealth services must include any supporting
documentation the requester wishes us to consider as we review the
request. Because we use the annual PFS rulemaking process as the
vehicle to make changes to the list of Medicare telehealth services,
requesters should be advised that any information submitted as part of
a request is subject to public disclosure for this purpose. For more
information on submitting a request to add services to the list of
Medicare telehealth services, including where to mail these requests,
see our website at https://www.cms.gov/Medicare/Medicare-General-
Information/Telehealth/.
c. Submitted Requests To Add Services to the List of Telehealth
Services for CY 2019
Under our current policy, we add services to the telehealth list on
a Category 1 basis when we determine that they are similar to services
on the existing telehealth list for the roles of, and interactions
among, the beneficiary, physician (or other practitioner) at the
distant site and, if necessary, the telepresenter. As we stated in the
CY 2012 PFS final rule with comment period (76 FR 73098), we believe
that the Category 1 criteria not only streamline our review process for
publicly requested services that fall into this category, but also
expedite our ability to identify codes for the telehealth list that
resemble those services already on this list.
We received several requests in CY 2017 to add various services as
Medicare telehealth services effective for CY 2019. The following
presents a discussion of these requests, and our proposals for
additions to the CY 2019 telehealth list. Of the requests received, we
found that two services were sufficiently similar to services currently
on the telehealth list to be added on a Category 1 basis. Therefore, we
proposed to add the following services to the telehealth list on a
Category 1 basis for CY 2019:
HCPCS codes G0513 and G0514 (Prolonged preventive
service(s) (beyond the typical service time of the primary procedure),
in the office or other outpatient setting requiring direct patient
contact beyond the usual service; first 30 minutes (list separately in
addition to code for preventive service) and (Prolonged preventive
service(s) (beyond the typical service time of the primary procedure),
in the office or other outpatient setting requiring direct patient
contact beyond the usual service; each additional 30 minutes (list
separately in addition to code G0513 for additional 30 minutes of
preventive service).
We found that the services described by HCPCS codes G0513 and G0514
are sufficiently similar to office visits currently on the telehealth
list. We believe that all the components of this service can be
furnished via interactive telecommunications technology. Additionally,
we believe that adding these services to the telehealth list will make
it administratively easier for practitioners who report these services
in connection with a preventive service that is furnished via
telehealth, as both the base code and the add-on code would be reported
with the telehealth place of service.
We also received requests to add services to the telehealth list
that do not meet our criteria for Medicare telehealth services. We did
not propose to add to the Medicare telehealth services list the
following procedures for chronic care remote physiologic monitoring,
interprofessional internet consultation, and initial hospital care; or
to change the requirements for subsequent hospital care or subsequent
nursing facility care, for the reasons noted in the paragraphs that
follow.
(1) Chronic Care Remote Physiologic Monitoring (CPT Codes 99453, 99454,
and 99457)
CPT code 99453 (Remote monitoring of physiologic
parameter(s) (e.g., weight, blood pressure, pulse oximetry, respiratory
flow rate), initial; set-up and patient education on use of equipment).
CPT code 99454 (Remote monitoring of physiologic
parameter(s) (e.g., weight, blood pressure, pulse oximetry, respiratory
flow rate), initial; device(s) supply with daily recording(s) or
programmed alert(s) transmission, each 30 days).
CPT code 99457 (Remote physiologic monitoring treatment
management services, 20 minutes or more of clinical staff/physician/
other qualified healthcare professional time in a calendar month
requiring interactive communication with the patient/caregiver during
the month).
In the CY 2016 PFS final rule with comment period (80 FR 71064), we
responded to a request to add CPT code 99490 (Chronic care management
services, at least 20 minutes of clinical staff time directed by a
physician or other qualified health care professional, per calendar
month, with the following required elements: Multiple (two or more)
chronic conditions expected to last at least 12 months, or until the
death of the patient; chronic conditions place the patient at
significant risk of death, acute exacerbation/decompensation, or
functional decline; comprehensive care plan established, implemented,
revised, or monitored) to the Medicare telehealth list. We discussed
that the services described by CPT code 99490 can be furnished without
the beneficiary's face-to-face presence and using any number of non-
face-to-face means of communication. We stated that it was therefore
unnecessary to add that service to the list of Medicare telehealth
services. Similarly, CPT codes 99453, 99454, and 99457 describe
services that are inherently non face-to-face. As discussed in section
II.H. of this final rule, Valuation of Specific Codes, we instead
proposed to adopt CPT codes 99453, 99454, and 99457 for payment under
the PFS. Because these codes describe services that are inherently non
face-to-face, we do not consider them Medicare telehealth services
under section 1834(m) of the Act; therefore, we did not propose to add
them to the list of Medicare telehealth services.
(2) Interprofessional Internet Consultation (CPT Codes 99451and 99452)
CPT code 99452 (Interprofessional telephone/internet/
electronic health record referral service(s) provided by a treating/
requesting physician or qualified health care professional, 30
minutes).
CPT code 99451 (Interprofessional telephone/internet/
electronic health record assessment and management service provided by
a consultative physician including a written report to the patient's
treating/requesting physician or other qualified health care
professional, 5 or more minutes of medical consultative time).
As discussed in section II.H. of this final rule, Valuation of
Specific Codes, we proposed to adopt CPT codes 99452 and 99451 for
payment under the PFS as these are distinct services furnished via
communication technology. Because these codes describe services that
are inherently non face-to-face, we do not consider them as Medicare
telehealth services under section 1834(m) of the Act; therefore we did
not propose to add them to the list of Medicare telehealth services for
CY 2019.
(3) Initial Hospital Care Services (CPT Codes 99221-99223)
CPT code 99221 (Initial hospital care, per day, for the
evaluation and

[[Page 59493]]

management of a patient, which requires these 3 key components: A
detailed or comprehensive history; A detailed or comprehensive
examination; and Medical decision making that is straightforward or of
low complexity. Counseling and/or coordination of care with other
physicians, other qualified health care professionals, or agencies are
provided consistent with the nature of the problem(s) and the patient's
and/or family's needs. Usually, the problem(s) requiring admission are
of low severity.)
CPT code 99222 (Initial hospital care, per day, for the
evaluation and management of a patient, which requires these 3 key
components: A comprehensive history; A comprehensive examination; and
Medical decision making of moderate complexity. Counseling and/or
coordination of care with other physicians, other qualified health care
professionals, or agencies are provided consistent with the nature of
the problem(s) and the patient's and/or family's needs. Usually, the
problem(s) requiring admission are of moderate severity.)
CPT code 99223 (Initial hospital care, per day, for the
evaluation and management of a patient, which requires these 3 key
components: A comprehensive history; A comprehensive examination; and
Medical decision making of high complexity. Counseling and/or
coordination of care with other physicians, other qualified health care
professionals, or agencies are provided consistent with the nature of
the problem(s) and the patient's and/or family's needs. Usually, the
problem(s) requiring admission are of high severity.)
We have previously considered requests to add these codes to the
telehealth list. As we stated in the CY 2011 PFS final rule with
comment period (75 FR 73315), while initial inpatient consultation
services are currently on the list of approved telehealth services,
there are no services on the current list of telehealth services that
resemble initial hospital care for an acutely ill patient by the
admitting practitioner who has ongoing responsibility for the patient's
treatment during the course of the hospital stay. Therefore, consistent
with prior rulemaking, we did not propose that initial hospital care
services be added to the Medicare telehealth services list on a
category 1 basis.
The initial hospital care codes describe the first visit of the
hospitalized patient by the admitting practitioner who may or may not
have seen the patient in the decision-making phase regarding
hospitalization. Based on the description of the services for these
codes, we believed it is critical that the initial hospital visit by
the admitting practitioner be conducted in person to ensure that the
practitioner with ongoing treatment responsibility comprehensively
assesses the patient's condition upon admission to the hospital through
a thorough in-person examination. Additionally, the requester submitted
no additional research or evidence that the use of a telecommunications
system to furnish the service produces demonstrated clinical benefit to
the patient; therefore, we also did not propose adding initial hospital
care services to the Medicare telehealth services list on a Category 2
basis.
We noted that Medicare beneficiaries who are being treated in the
hospital setting can receive reasonable and necessary E/M services
using other HCPCS codes that are currently on the Medicare telehealth
list, including those for subsequent hospital care, initial and follow-
up telehealth inpatient and emergency department consultations, as well
as initial and follow-up critical care telehealth consultations.
Therefore, we did not propose to add the initial hospital care
services to the list of Medicare telehealth services for CY 2019.
(4) Subsequent Hospital Care Services (CPT Codes 99231-99233)
CPT code 99231 (Subsequent hospital care, per day, for the
evaluation and management of a patient, which requires at least 2 of
these 3 key components: A problem focused interval history; A problem
focused examination; Medical decision making that is straightforward or
of low complexity. Counseling and/or coordination of care with other
physicians, other qualified health care professionals, or agencies are
provided consistent with the nature of the problem(s) and the patient's
and/or family's needs. Usually, the patient is stable, recovering or
improving. Typically, 15 minutes are spent at the bedside and on the
patient's hospital floor or unit.).
CPT code 99232 (Subsequent hospital care, per day, for the
evaluation and management of a patient, which requires at least 2 of
these 3 key components: An expanded problem focused interval history;
an expanded problem focused examination; medical decision making of
moderate complexity. Counseling and/or coordination of care with other
physicians, other qualified health care professionals, or agencies are
provided consistent with the nature of the problem(s) and the patient's
and/or family's needs. Usually, the patient is responding inadequately
to therapy or has developed a minor complication. Typically, 25 minutes
are spent at the bedside and on the patient's hospital floor or unit.).
CPT code 99233 (Subsequent hospital care, per day, for the
evaluation and management of a patient, which requires at least 2 of
these 3 key components: A detailed interval history; a detailed
examination; Medical decision making of high complexity. Counseling
and/or coordination of care with other physicians, other qualified
health care professionals, or agencies are provided consistent with the
nature of the problem(s) and the patient's and/or family's needs.
Usually, the patient is unstable or has developed a significant
complication or a significant new problem. Typically, 35 minutes are
spent at the bedside and on the patient's hospital floor or unit.).
CPT codes 99231-99233 are currently on the list of Medicare
telehealth services, but can only be billed via telehealth once every 3
days. The requester requested that we remove the frequency limitation.
We stated in the CY 2011 PFS final rule with comment period (75 FR
73316) that, although we still believed the potential acuity of
hospital inpatients is greater than those patients likely to receive
Medicare telehealth services that were on the list at that time, we
also believed that it would be appropriate to permit some subsequent
hospital care services to be furnished through telehealth in order to
ensure that hospitalized patients have frequent encounters with their
admitting practitioner. We also noted that we continue to believe that
the majority of these visits should be in-person to facilitate the
comprehensive, coordinated, and personal care that medically volatile,
acutely ill patients require on an ongoing basis. Because of our
concerns regarding the potential acuity of hospital inpatients, we
finalized the addition of CPT codes 99231-99233 to the list of Medicare
telehealth services, but limited the provision of these subsequent
hospital care services through telehealth to once every 3 days. We
continue to believe that admitting practitioners should continue to
make appropriate in-person visits to all patients who need such care
during their hospitalization. Our concerns and position on the
provision of subsequent hospital care services via telehealth have not
changed. Therefore, we did not propose to remove the frequency
limitation on these codes.

[[Page 59494]]

(5) Subsequent Nursing Facility Care Services (CPT Codes 99307-99310)
CPT code 99307 (Subsequent nursing facility care, per day,
for the evaluation and management of a patient, which requires at least
2 of these 3 key components: A problem focused interval history; A
problem focused examination; Straightforward medical decision making.
Counseling and/or coordination of care with other physicians, other
qualified health care professionals, or agencies are provided
consistent with the nature of the problem(s) and the patient's and/or
family's needs. Usually, the patient is stable, recovering, or
improving. Typically, 10 minutes are spent at the bedside and on the
patient's facility floor or unit.).
CPT code 99308 (Subsequent nursing facility care, per day,
for the evaluation and management of a patient, which requires at least
2 of these 3 key components: An expanded problem focused interval
history; an expanded problem focused examination; Medical decision
making of low complexity. Counseling and/or coordination of care with
other physicians, other qualified health care professionals, or
agencies are provided consistent with the nature of the problem(s) and
the patient's and/or family's needs. Usually, the patient is responding
inadequately to therapy or has developed a minor complication.
Typically, 15 minutes are spent at the bedside and on the patient's
facility floor or unit.).
CPT code 99309 (Subsequent nursing facility care, per day,
for the evaluation and management of a patient, which requires at least
2 of these 3 key components: A detailed interval history; a detailed
examination; Medical decision making of moderate complexity. Counseling
and/or coordination of care with other physicians, other qualified
health care professionals, or agencies are provided consistent with the
nature of the problem(s) and the patient's and/or family's needs.
Usually, the patient has developed a significant complication or a
significant new problem. Typically, 25 minutes are spent at the bedside
and on the patient's facility floor or unit.).
CPT code 99310 (Subsequent nursing facility care, per day,
for the evaluation and management of a patient, which requires at least
2 of these 3 key components: A comprehensive interval history; a
comprehensive examination; Medical decision making of high complexity.
Counseling and/or coordination of care with other physicians, other
qualified health care professionals, or agencies are provided
consistent with the nature of the problem(s) and the patient's and/or
family's needs. The patient may be unstable or may have developed a
significant new problem requiring immediate physician attention.
Typically, 35 minutes are spent at the bedside and on the patient's
facility floor or unit.).
CPT codes 99307-99310 are currently on the list of Medicare
telehealth services, but can only be billed via telehealth once every
30 days. The requester requested that we remove the frequency
limitation when these services are provided for psychiatric care. We
stated in the CY 2011 PFS final rule with comment period (75 FR 73317)
that we believed it would be appropriate to permit some subsequent
nursing facility care services to be furnished through telehealth to
ensure that complex nursing facility patients have frequent encounters
with their admitting practitioner, but because of our concerns
regarding the potential acuity and complexity of SNF inpatients, we
limited the provision of subsequent nursing facility care services
furnished through telehealth to once every 30 days. Since these codes
are used to report care for patients with a variety of diagnoses,
including psychiatric diagnoses, we do not think it would be
appropriate to remove the frequency limitation only for certain
diagnoses. The services described by these CPT codes are essentially
the same service, regardless of the patient's diagnosis. We also
continue to have concerns regarding the potential acuity and complexity
of SNF inpatients, and therefore, we did not propose to remove the
frequency limitation for subsequent nursing facility care services in
CY 2019.
In summary, we proposed to add the following codes to the list of
Medicare telehealth services beginning in CY 2019 on a category 1
basis:
HCPCS code G0513 (Prolonged preventive service(s) (beyond
the typical service time of the primary procedure), in the office or
other outpatient setting requiring direct patient contact beyond the
usual service; first 30 minutes (list separately in addition to code
for preventive service).
HCPCS code G0514 (Prolonged preventive service(s) (beyond
the typical service time of the primary procedure), in the office or
other outpatient setting requiring direct patient contact beyond the
usual service; each additional 30 minutes (list separately in addition
to code G0513 for additional 30 minutes of preventive service).
Comment: Commenters were unanimously supportive of our proposal to
add HCPCS codes G0513 and G0514 to the Medicare telehealth list. A few
commenters noted they were disappointed that we did not propose to add
the initial hospital care codes to the telehealth list and that we did
not propose to lift the frequency limitation on the subsequent hospital
care and subsequent nursing facility care codes.
Response: We are finalizing adding HCPCS codes G0513 and G0514 to
the Medicare telehealth list. We are not adding the initial hospital
care codes to the telehealth list and we are not removing the frequency
limitations on the subsequent hospital care and subsequent nursing
facility care codes for the reasons noted above.
Comment: Several commenters suggested that CMS conduct a pilot or
demonstration program to evaluate the clinical benefit of physical
therapists, occupational therapists, and speech-language pathologists
furnishing telehealth services to Medicare beneficiaries in states that
permit such services, noting that this would improve beneficiary access
to therapy services, and help to inform policymakers as they consider
whether to recognize such healthcare professionals as authorized
providers of telehealth under the Social Security Act.
Response: While we did not include any proposals on this topic in
the proposed rule, we reiterate our commitment to expanding access to
telehealth services consistent with statutory authority, and paying
appropriately for services that maximize telecommunications technology.
Regarding the possibility of a model or demonstration, we will consider
the comments as we develop new models through the Center for Medicare
and Medicaid Innovation. We note that we would need to determine
whether such a model or demonstration would meet the statutory
requirements, which generally require that the test be expected to
reduce Medicare expenditures and preserve or enhance the quality of
care for beneficiaries.
5. Expanding the Use of Telehealth Under the Bipartisan Budget Act of
2018
a. Expanding Access to Home Dialysis Therapy Under the Bipartisan
Budget Act of 2018
Section 50302 of the BBA of 2018 amended sections 1881(b)(3) and
1834(m) of the Act to allow an individual determined to have end-stage
renal disease receiving home dialysis to choose to receive certain
monthly end-stage renal disease-related (ESRD-related) clinical
assessments via telehealth on or after January 1, 2019.

[[Page 59495]]

The new section 1881(b)(3)(B)(ii) of the Act requires that such an
individual must receive a face-to-face visit, without the use of
telehealth, at least monthly in the case of the initial 3 months of
home dialysis and at least once every 3 consecutive months after the
initial 3 months.
As added by section 50302(b)(1) of the BBA of 2018, subclauses (IX)
and (X) of section 1834(m)(4)(C)(ii) of the Act include a renal
dialysis facility and the home of an individual as telehealth
originating sites but only for the purposes of the monthly ESRD-related
clinical assessments furnished through telehealth provided under
section 1881(b)(3)(B) of the Act. Section 50302(b)(1) of the BBA of
2018, also added a new section 1834(m)(5) of the Act which provides
that the geographic requirements for telehealth services under section
1834(m)(4)(C)(i) of the Act do not apply to telehealth services
furnished on or after January 1, 2019 for purposes of the monthly ESRD-
related clinical assessments where the originating site is a hospital-
based or critical access hospital-based renal dialysis center, a renal
dialysis facility, or the home of an individual. Section 50302(b)(2) of
the BBA of 2018 amended section 1834(m)(2)(B)(ii) of the Act to require
that no originating site facility fee is to be paid if the home of the
individual is the originating site.
Our current regulation at Sec. 410.78 specifies the conditions
that must be met in order for Medicare Part B to pay for covered
telehealth services included on the telehealth list when furnished by
an interactive telecommunications system. In accordance with the new
subclauses (IX) and (X) of section 1834(m)(4)(C)(ii) of the Act, we
proposed to revise our regulation at Sec. 410.78(b)(3) to add a renal
dialysis facility and the home of an individual as Medicare telehealth
originating sites, but only for purposes of the home dialysis monthly
ESRD-related clinical assessment in section 1881(b)(3)(B) of the Act.
We proposed to amend Sec. 414.65(b)(3) to reflect the requirement in
section 1834(m)(2)(B)(ii) of the Act that there is no originating site
facility fee paid when the originating site for these services is the
patient's home. Additionally, we proposed to add new Sec.
410.78(b)(4)(iv)(A), to reflect the provision in section 1834(m)(5) of
the Act, added by section 50302 of the BBA of 2018, specifying that the
geographic requirements described in section 1834(m)(4)(C)(i) of the
Act do not apply with respect to telehealth services furnished on or
after January 1, 2019, in originating sites that are hospital-based or
critical access hospital-based renal dialysis centers, renal dialysis
facilities, or the patient's home, respectively under sections
1834(m)(4)(C)(ii)(VI), (IX) and (X) of the Act, for purposes of section
1881(b)(3)(B) of the Act.
Commenters supported our proposals to revise the regulation text at
Sec. Sec. 410.78 and 414.65 to implement the requirements of section
50302 of the BBA of 2018 for expanding access to home dialysis therapy
through telehealth. We are finalizing these regulation text changes as
proposed.
b. Expanding the Use of Telehealth for Individuals With Stroke Under
the Bipartisan Budget Act of 2018
Section 50325 of the BBA of 2018 amended section 1834(m) of the Act
by adding a new paragraph (6) that provides special rules for
telehealth services furnished on or after January 1, 2019, for purposes
of diagnosis, evaluation, or treatment of symptoms of an acute stroke
(acute stroke telehealth services), as determined by the Secretary.
Specifically, section 1834(m)(6)(A) of the Act removes the restrictions
on the geographic locations and the types of originating sites where
acute stroke telehealth services can be furnished. Section
1834(m)(6)(B) of the Act specifies that acute stroke telehealth
services can be furnished in any hospital, critical access hospital,
mobile stroke units (as defined by the Secretary), or any other site
determined appropriate by the Secretary, in addition to the current
eligible telehealth originating sites. Section 1834(m)(6)(C) of the Act
limits payment of an originating site facility fee to acute stroke
telehealth services furnished in sites that meet the usual telehealth
restrictions under section 1834(m)(4)(C) of the Act.
To implement these requirements, we proposed to create a new
modifier that would be used to identify acute stroke telehealth
services. The practitioner and, as appropriate, the originating site,
would append this modifier when clinically appropriate to the HCPCS
code when billing for an acute stroke telehealth service or an
originating site facility fee, respectively. We note that section 50325
of the BBA of 2018 did not amend section 1834(m)(4)(F) of the Act,
which limits the scope of telehealth services to those on the Medicare
telehealth list. Practitioners would be responsible for assessing
whether it would be clinically appropriate to use this modifier with
codes from the Medicare telehealth list. By billing with this modifier,
practitioners would be indicating that the codes billed were used to
furnish telehealth services for diagnosis, evaluation, or treatment of
symptoms of an acute stroke. We believe that the adoption of a service
level modifier is the least administratively burdensome means of
implementing this provision for practitioners, while also allowing CMS
to easily track and analyze utilization of these services.
In accordance with section 1834(m)(6)(B) of the Act, as added by
section 50325 of the BBA of 2018, we also proposed to revise Sec.
410.78(b)(3) to add mobile stroke unit as a permissible originating
site for acute stroke telehealth services. We proposed to define a
mobile stroke unit as a mobile unit that furnishes services to
diagnose, evaluate, and/or treat symptoms of an acute stroke and
solicited comment on this definition, as well as additional information
on how these units are used in current medical practice. We therefore
proposed that mobile stroke units and the current eligible telehealth
originating sites, which include hospitals and critical access
hospitals as specified in section 1834(m)(6)(B) of the Act, but
excluding renal dialysis facilities and patient homes because they are
only allowable originating sites for purposes of home dialysis monthly
ESRD-related clinical assessments in section 1881(b)(3)(B) of the Act,
would be permissible originating sites for acute stroke telehealth
services.
We also solicited comment on other possible appropriate originating
sites for telehealth services furnished for the diagnosis, evaluation,
or treatment of symptoms of an acute stroke. Any additional sites would
be adopted through future rulemaking. As required under section
1834(m)(6)(C) of the Act, the originating site facility fee would not
apply in instances where the originating site does not meet the
originating site type and geographic requirements under section
1834(m)(4)(C) of the Act. Additionally, we proposed to add Sec. 410.78
(b)(4)(iv)(B) to specify that the requirements in section 1834(m)(4)(C)
of the Act do not apply with respect to telehealth services furnished
on or after January 1, 2019, for purposes of diagnosis, evaluation, or
treatment of symptoms of an acute stroke.
Comment: Commenters supported the expansions to Medicare
telehealth. The majority of commenters agreed with our proposed
definition of a mobile stroke unit. However, the AMA suggested that CMS
specify in the definition that a mobile stroke unit must include a
computed tomographic (CT) scanner and a telehealth (audio and video)
connection or an in-person physician who is able to interpret the CT
scan and prescribe an intravenous thrombolysis and also have a
qualified health

[[Page 59496]]

professional who is able to administer an intravenous thrombolysis if
the physician interpreting the CT scan and prescribing the treatment
does so via telehealth. The AMA also suggested that CMS add as an
originating site Emergency Medical Service (EMS) transports equipped
with a telehealth connection to stroke specialists in order to provide
faster national access to patients who require an accurate stroke
diagnosis and decision about eligibility for intravenous or
endovascular therapy, and to determine where to take them (such as a
primary stroke or comprehensive stroke center). One commenter urged CMS
to distinguish between a mobile stroke unit and a standard ambulance
that is equipped with telemedicine capability and to establish separate
payment for each, noting that a telemedicine consult on a mobile stroke
unit may involve much greater complexity and critical care treatment
than on a standard ambulance that is equipped with telemedicine
capability. Another commenter recommended that CMS require specially
trained paramedics who can evaluate an acute ischemic stroke patient
based on national standards.
Response: We are finalizing the changes to the regulation text and
the definition of a mobile stroke unit as proposed without
modification. We believe that clinicians are in the best position to
make decisions about what equipment and professional support are
required in furnishing these services. We plan to monitor utilization
of these services and will consider making refinements, including those
suggested by commenters, through future rulemaking as necessary. We
would welcome additional information to help us understand the merits
of the commenters' suggestions, including those regarding specific
equipment and staffing requirements for mobile stroke units.
In summary, we are finalizing a new modifier that will be used to
identify acute stroke telehealth services. The practitioner and, as
appropriate, the originating site, will append this modifier to the
HCPCS code as clinically appropriate when billing for an acute stroke
telehealth service or an originating site facility fee, respectively.
We are finalizing the regulation text changes at Sec. Sec. 410.78 and
414.65 as proposed to implement the requirements of section 50325 of
the BBA of 2018 for acute stroke telehealth services. Mobile stroke
units, with the definition as proposed, and the current eligible
telehealth originating sites, which include hospitals and critical
access hospitals, but exclude renal dialysis facilities and patient
homes because they are originating sites only for purposes of home
dialysis monthly ESRD-related clinical assessments in section
1881(b)(3)(B) of the Act, will be permissible originating sites for
acute stroke telehealth services.
6. Requirements of the Substance Use-Disorder Prevention That Promotes
Opioid Recovery and Treatment (SUPPORT) for Patients and Communities
Act
a. Expanding Medicare Telehealth Services for the Treatment of Opioid
Use Disorder and Other Substance Use Disorders--Interim Final Rule With
Comment Period
Section 2001(a) of the SUPPORT for Patients and Communities Act
(Pub. L. 115-271, October 24, 2018) (the SUPPORT Act) makes several
revisions to section 1834(m) of the Act. First, it removes the
originating site geographic requirements under section 1834(m)(4)(C)(i)
for telehealth services furnished on or after July 1, 2019 for the
purpose of treating individuals diagnosed with a substance use disorder
or a co-occurring mental health disorder, as determined by the
Secretary, at an originating site described in section
1834(m)(4)(C)(ii) of the Act, other than an originating site described
in subclause (IX) of section 1834(m)(4)(C)(ii) of the Act. The site
described in subclause (IX) of section 1834(m)(4)(C)(ii) of the Act is
a renal dialysis facility, which is only an allowable originating site
for purposes of home dialysis monthly ESRD-related clinical assessments
in section 1881(b)(3)(B) of the Act. It also adds the home of an
individual as a permissible originating site for these telehealth
services. Section 2001(a) of the SUPPORT Act for Patients and
Communities Act additionally amends section 1834(m) of the Act to
require that no originating site facility fee will be paid in instances
when the individual's home is the originating site. Section 2001(b) of
the SUPPORT for Patients and Communities Act grants the Secretary
specific authority to implement the amendments made by section 2001(a)
through an interim final rule.
Under the authority of section 2001(b) of the SUPPORT for Patients
and Communities Act, we are issuing an interim final rule with comment
period to implement the requirements of section 2001(a) of the SUPPORT
for Patients and Communities Act. In accordance with section
1834(m)(2)(B)(ii)(X) of the Act, as amended by section 2001(a) of the
SUPPORT for Patients and Communities Act, we are revising Sec.
410.78(b)(3) on an interim final basis, by adding Sec.
410.78(b)(3)(xii), which adds the home of an individual as a
permissible originating site for telehealth services furnished on or
after July 1, 2019 to individuals with a substance use disorder
diagnosis for purposes of treatment of a substance use disorder or a
co-occurring mental health disorder. We are amending Sec. 414.65(b)(3)
on an interim final basis to reflect the requirement in section
1834(m)(2)(B)(ii) of the Act that there is no originating site facility
fee paid when the originating site for these services is the
individual's home. Additionally, we are adding Sec.
410.78(b)(4)(iv)(C) on an interim final basis to specify that the
geographic requirements in section 1834(m)(4)(C)(i) of the Act do not
apply for telehealth services furnished on or after July 1, 2019, to
individuals with a substance use disorder diagnosis for purposes of
treatment of a substance use disorder or a co-occurring mental health
disorder at an originating site other than a renal dialysis facility.
We note that section 2001 of the SUPPORT for Patients and
Communities Act did not amend section 1834(m)(4)(F) of the Act, which
limits the scope of telehealth services to those on the Medicare
telehealth list. Practitioners would be responsible for assessing
whether individuals have a substance use disorder diagnosis and whether
it would be clinically appropriate to furnish telehealth services for
the treatment of the individual's substance use disorder or a co-
occurring mental health disorder. By billing codes on the Medicare
telehealth list with the telehealth place of service code,
practitioners would be indicating that the codes billed were used to
furnish telehealth services to individuals with a substance use
disorder diagnosis for the purpose of treating the substance use
disorder or a co-occurring mental health disorder. We note that we may
issue additional subregulatory guidance in the future for billing these
telehealth services.
We note that there is a 60-day period following publication of this
interim final rule for the public to comment on these interim final
amendments to our regulations. We invite public comment on our policies
to implement section 2001 of the SUPPORT for Patients and Communities
Act.

[[Page 59497]]

b. Medicare Payment for Certain Services Furnished by Opioid Treatment
Programs (OTPs)--Request for Information
Section 2005 of the SUPPORT Act establishes a new Medicare benefit
category for opioid use disorder treatment services furnished by OTPs
under Medicare Part B, beginning on or after January 1, 2020. This
provision requires that opioid use disorder treatment services would
include FDA-approved opioid agonist and antagonist treatment
medications, the dispensing and administration of such medications (if
applicable), substance use disorder counseling, individual and group
therapy, toxicology testing, and other services determined appropriate
(but in no event to include meals and transportation). The provision
defines OTPs as those that enroll in Medicare and are certified by the
Substance Abuse and Mental Health Services Administration (SAMHSA),
accredited by a SAMHSA-approved entity, and meeting additional
conditions as the Secretary finds necessary to ensure the health and
safety of individuals being furnished services under these programs and
the effective and efficient furnishing of such services.
We note that there is a 60-day period for the public to comment on
the provisions of the interim final rule described previously to
implement section 2001 of the SUPPORT for Patients and Communities Act.
During that same comment period, we are requesting information
regarding services furnished by OTPs, payments for these services, and
additional conditions for Medicare participation for OTPs that
stakeholders believe may be useful for us to consider for future
rulemaking to implement this new Medicare benefit category.
7. Modifying Sec. 414.65 Regarding List of Telehealth Services
In the CY 2015 PFS final rule with comment period, we finalized a
proposal to change our regulation at Sec. 410.78(b) by deleting the
description of the individual services for which Medicare payment can
be made when furnished via telehealth, noting that we revised Sec.
410.78(f) to indicate that a list of Medicare telehealth codes and
descriptors is available on the CMS website (79 FR 67602). In
accordance with that change, we proposed a technical revision to also
delete the description of individual services and exceptions for
Medicare payment for telehealth services in Sec. 414.65, by amending
Sec. 414.65(a) to note that Medicare payment for telehealth services
is addressed in Sec. 410.78 and by deleting Sec. 414.65(a)(1).
Comment: Commenters were supportive of CMS making a technical
revision to delete the description of individual services and
exceptions for Medicare payment for telehealth services in Sec.
414.65.
Response: We are finalizing the technical revision to Sec. 414.65
as proposed.
8. Comment Solicitation on Creating a Bundled Episode of Care for
Management and Counseling Treatment for Substance Use Disorders
There is an evidence base that suggests that routine counseling,
either associated with medication assisted treatment (MAT) or on its
own, can increase the effectiveness of treatment for substance use
disorders (SUDs). According to a study in the Journal of Substance
Abuse Treatment,\1\ patients treated with a combination of web-based
counseling as part of a substance abuse treatment program demonstrated
increased treatment adherence and satisfaction. The federal guidelines
for opioid treatment programs describe that MAT and wrap-around
psychosocial and support services can include the following services:
Physical exam and assessment; psychosocial assessment; treatment
planning; counseling; medication management; drug administration;
comprehensive care management and supportive services; care
coordination; management of care transitions; individual and family
support services; and health promotion (https://store.samhsa.gov/shin/
content/PEP15-FEDGUIDEOTP/PEP15-FEDGUIDEOTP.pdf). Creating separate
payment for a bundled episode of care for components of MAT such as
management and counseling treatment for substance use disorders (SUD),
including opioid use disorder, treatment planning, and medication
management or observing drug dosing for treatment of SUDs under the PFS
could provide opportunities to better leverage services furnished with
communication technology while expanding access to treatment for SUDs.
---------------------------------------------------------------------------

\1\ Van L. King, Robert K. Brooner, Jessica M. Peirce, Ken
Kolodner, Michael S. Kidorf, ``A randomized trial of Web based
videoconferencing for substance abuse counseling,'' Journal of
Substance Abuse Treatment, Volume 46, Issue 1, 2014, Pages 36-42,
https://www.sciencedirect.com/science/article/pii/S0740547213001876.
---------------------------------------------------------------------------

We also believe making separate payment for a bundled episode of
care for management and counseling for SUDs could be effective in
preventing the need for more acute services. For example, according to
the Healthcare Cost and Utilization Project,\2\ Medicare pays for one-
third of opioid-related hospital stays, and Medicare has seen the
largest annual increase in the number of these stays over the past 2
decades. We believe that separate payment for a bundled episode of care
could help avoid such hospital admissions by supporting access to
management and counseling services that could be important in
preventing hospital admissions and other acute care events.
---------------------------------------------------------------------------

\2\ Pamela L. Owens, Ph.D., Marguerite L. Barrett, M.S., Audrey
J. Weiss, Ph.D., Raynard E. Washington, Ph.D., and Richard Kronick,
Ph.D. ``Hospital Inpatient Utilization Related to Opioid Overuse
Among Adults 1993-2012,'' Statistical Brief #177. Healthcare Cost
and Utilization Project (HCUP). July 2014. Agency for Healthcare
Research and Quality, Rockville, MD, https://www.hcup-us.ahrq.gov/
reports/statbriefs/sb177-Hospitalizations-for-Opioid-Overuse.jsp.
---------------------------------------------------------------------------

As indicated earlier, we considered whether it would be appropriate
to develop a separate bundled payment for an episode of care for
treatment of SUDs. We solicited public comment on whether such a
bundled episode-based payment would be beneficial to improve access,
quality and efficiency for SUD treatment. Further, we solicited public
comment on developing coding and payment for a bundled episode of care
for treatment for SUDs that could include overall treatment management,
any necessary counseling, and components of a MAT program such as
treatment planning, medication management, and observation of drug
dosing. Specifically, we solicited public comments related to what
assumptions we might make about the typical number of counseling
sessions as well as the duration of the service period, which types of
practitioners could furnish these services, and what components of MAT
could be included in the bundled episode of care. We were interested in
stakeholder feedback regarding how to define and value this bundle and
what conditions of payment should be attached. Additionally, we
solicited comment on whether the concept of a global period, similar to
the currently existing global periods for surgical procedures, might be
applicable to treatment for SUDs.
We also solicited comment on whether the counseling portion and
other MAT components could also be provided by qualified practitioners
``incident to'' the services of the billing physician who will
administer or prescribe any necessary medications and manage the
overall care, as well as supervise any other counselors participating
in the treatment, similar to the structure of the Behavioral Health
Integration codes which include

[[Page 59498]]

services provided by other members of the care team under the direction
of the billing practitioner on an ``incident to'' basis (81 FR 80231).
We welcomed comments on potentially creating a bundled episode of care
for management and counseling treatment for SUDs, which we will
consider for future rulemaking.
Comment: We received several comments with detailed information on
this topic. Some commenters expressed concern that the format of a
bundled episode of care may fail to take into account the wide
variability in patient needs for treatment of SUDs, especially given
the chronic nature of SUDs, which like other chronic diseases,
typically involves ongoing treatment without a definitive end point.
Some commenters additionally noted that a global period would not lend
itself to treatment of SUDs, because the treatment is not an acute
intervention like surgery; rather, patients with SUDs may require
increasing and decreasing access to care, depending on their progress
in treatment.
Response: We thank the commenters for all of the information
submitted and will consider this feedback for future rulemaking. We
agree with commenters and understand that there is wide variability in
patient needs for treatment of SUDs, and that unlike surgical global
periods, ongoing treatment is often necessary in the treatment of SUDs.
While we do not necessarily believe these characteristics preclude
payment bundles and/or global periods, we do understand they would need
to be taken into account. We reiterate that our intention as we
consider these issues for future rulemaking is to increase access to
necessary care, and that any potential bundled payment would be
developed in consideration of these comments.
We note that there is a 60-day period for the public to comment on
the interim final telehealth policies and revisions to our regulations
we are adopting to implement statutory amendments to section 1834(m) of
the Act that expand access to telehealth services used to treat
substance use disorders. During that same comment period, we are
requesting additional information from stakeholders and the public that
we might consider for future rulemaking regarding payment structure and
amounts for SUD treatment that account for ongoing treatment and wide
variability in patient needs for treatment of SUDs while improving
access to necessary care.
Additionally, we invited public comment and suggestions for
regulatory and subregulatory changes to help prevent opioid use
disorder and improve access to treatment under the Medicare program. We
solicited comment on methods for identifying non-opioid alternatives
for pain treatment and management, along with identifying barriers that
may inhibit access to these non-opioid alternatives including barriers
related to payment or coverage. Consistent with our ``Patients Over
Paperwork'' Initiative, we were interested in suggestions to improve
existing requirements to more effectively address the opioid epidemic.
Comment: We received several comments with detailed information on
this topic.
Response: We thank the commenters for all of the information
submitted and will consider this for future rulemaking.
9. Telehealth Originating Site Facility Fee Payment Amount Update
Section 1834(m)(2)(B) of the Act established the Medicare
telehealth originating site facility fee for telehealth services
furnished from October 1, 2001 through December 31, 2002, at $20.00.
For telehealth services furnished on or after January 1 of each
subsequent calendar year, the telehealth originating site facility fee
is increased by the percentage increase in the Medicare Economic Index
(MEI) as defined in section 1842(i)(3) of the Act. The originating site
facility fee for telehealth services furnished in CY 2018 is $25.76.
The MEI increase for 2019 is 1.5 percent and is based on the most
recent historical update of the MEI through 2018Q2 (2.0 percent), and
the most recent historical multifactor productivity adjustment (MFP)
through calendar year 2017 (0.5 percent). Therefore, for CY 2019, the
payment amount for HCPCS code Q3014 (Telehealth originating site
facility fee) is 80 percent of the lesser of the actual charge or
$26.15. The Medicare telehealth originating site facility fee and the
MEI increase by the applicable time period is shown in Table 10.

Table 10--The Medicare Telehealth Originating Site Facility Fee
------------------------------------------------------------------------
MEI Facility
Time period increase fee
------------------------------------------------------------------------
10/01/2001-12/31/2002............................... N/A $20.00
01/01/2003-12/31/2003............................... 3.0 20.60
01/01/2004-12/31/2004............................... 2.9 21.20
01/01/2005-12/31/2005............................... 3.1 21.86
01/01/2006-12/31/2006............................... 2.8 22.47
01/01/2007-12/31/2007............................... 2.1 22.94
01/01/2008-12/31/2008............................... 1.8 23.35
01/01/2009-12/31/2009............................... 1.6 23.72
01/01/2010-12/31/2010............................... 1.2 24.00
01/01/2011-12/31/2011............................... 0.4 24.10
01/01/2012-12/31/2012............................... 0.6 24.24
01/01/2013-12/31/2013............................... 0.8 24.43
01/01/2014-12/31/2014............................... 0.8 24.63
01/01/2015-12/31/2015............................... 0.8 24.83
01/01/2016-12/31/2016............................... 1.1 25.10
01/01/2017-12/31/2017............................... 1.2 25.40
01/01/2018-12/31/2018............................... 1.4 25.76
01/01/2019-12/31/2019............................... 1.5 26.15
------------------------------------------------------------------------

E. Potentially Misvalued Services Under the PFS

1. Background
Section 1848(c)(2)(B) of the Act directs the Secretary to conduct a
periodic review, not less often than every 5 years, of the RVUs
established under the PFS. Section 1848(c)(2)(K) of the Act requires
the Secretary to periodically identify potentially misvalued services
using certain criteria and to review and make appropriate adjustments
to the relative values for those services. Section 1848(c)(2)(L) of the
Act also requires the Secretary to develop a process to validate the
RVUs of certain potentially misvalued codes under the PFS, using the
same criteria used to identify potentially misvalued codes, and to make
appropriate adjustments.
As discussed in section II.H. of this final rule, Valuation of
Specific Codes, each year we develop appropriate adjustments to the
RVUs taking into account recommendations provided by the RUC, MedPAC,
and other stakeholders. For many years, the RUC has provided us with
recommendations on the appropriate relative values for new, revised,
and potentially misvalued PFS services. We review these recommendations
on a code-by-code basis and consider these recommendations in
conjunction with analyses of other data, such as claims data, to inform
the decision-making process as authorized by law. We may also consider
analyses of work time, work RVUs, or direct PE inputs using other data
sources, such as Department of Veteran Affairs (VA), National Surgical
Quality Improvement Program (NSQIP), the Society for Thoracic Surgeons
(STS), and the Merit-based Incentive Payment System (MIPS) data. In
addition to considering the most recently available data, we assess the
results of physician surveys and specialty recommendations submitted to
us by the RUC for our review. We also consider information provided by
other stakeholders. We conduct a review to assess the appropriate RVUs
in the context of contemporary medical practice. We note that section

[[Page 59499]]

1848(c)(2)(A)(ii) of the Act authorizes the use of extrapolation and
other techniques to determine the RVUs for physicians' services for
which specific data are not available and requires us to take into
account the results of consultations with organizations representing
physicians who provide the services. In accordance with section 1848(c)
of the Act, we determine and make appropriate adjustments to the RVUs.
In its March 2006 Report to the Congress (https://www.medpac.gov/
docs/default-source/reports/Mar06_Ch03.pdf?sfvrsn=0), MedPAC discussed
the importance of appropriately valuing physicians' services, noting
that misvalued services can distort the market for physicians'
services, as well as for other health care services that physicians
order, such as hospital services. In that same report, MedPAC
postulated that physicians' services under the PFS can become misvalued
over time. MedPAC stated, ``When a new service is added to the
physician fee schedule, it may be assigned a relatively high value
because of the time, technical skill, and psychological stress that are
often required to furnish that service. Over time, the work required
for certain services would be expected to decline as physicians become
more familiar with the service and more efficient in furnishing it.''
We believe services can also become overvalued when PE declines. This
can happen when the costs of equipment and supplies fall, or when
equipment is used more frequently than is estimated in the PE
methodology, reducing its cost per use. Likewise, services can become
undervalued when physician work increases or PE rises.
As MedPAC noted in its March 2009 Report to Congress (https://
www.medpac.gov/docs/default-source/reports/march-2009-report-to-
congress-medicare-payment-policy.pdf), in the intervening years since
MedPAC made the initial recommendations, CMS and the RUC have taken
several steps to improve the review process. Also, section
1848(c)(2)(K)(ii) of the Act augments our efforts by directing the
Secretary to specifically examine, as determined appropriate,
potentially misvalued services in the following categories:
Codes that have experienced the fastest growth.
Codes that have experienced substantial changes in PE.
Codes that describe new technologies or services within an
appropriate time period (such as 3 years) after the relative values are
initially established for such codes.
Codes which are multiple codes that are frequently billed
in conjunction with furnishing a single service.
Codes with low relative values, particularly those that
are often billed multiple times for a single treatment.
Codes that have not been subject to review since
implementation of the fee schedule.
Codes that account for the majority of spending under the
PFS.
Codes for services that have experienced a substantial
change in the hospital length of stay or procedure time.
Codes for which there may be a change in the typical site
of service since the code was last valued.
Codes for which there is a significant difference in
payment for the same service between different sites of service.
Codes for which there may be anomalies in relative values
within a family of codes.
Codes for services where there may be efficiencies when a
service is furnished at the same time as other services.
Codes with high intraservice work per unit of time.
Codes with high PE RVUs.
Codes with high cost supplies.
Codes as determined appropriate by the Secretary.
Section 1848(c)(2)(K)(iii) of the Act also specifies that the
Secretary may use existing processes to receive recommendations on the
review and appropriate adjustment of potentially misvalued services. In
addition, the Secretary may conduct surveys, other data collection
activities, studies, or other analyses, as the Secretary determines to
be appropriate, to facilitate the review and appropriate adjustment of
potentially misvalued services. This section also authorizes the use of
analytic contractors to identify and analyze potentially misvalued
codes, conduct surveys or collect data, and make recommendations on the
review and appropriate adjustment of potentially misvalued services.
Additionally, this section provides that the Secretary may coordinate
the review and adjustment of any RVU with the periodic review described
in section 1848(c)(2)(B) of the Act. Section 1848(c)(2)(K)(iii)(V) of
the Act specifies that the Secretary may make appropriate coding
revisions (including using existing processes for consideration of
coding changes) that may include consolidation of individual services
into bundled codes for payment under the PFS.
2. Progress in Identifying and Reviewing Potentially Misvalued Codes
To fulfill our statutory mandate, we have identified and reviewed
numerous potentially misvalued codes as specified in section
1848(c)(2)(K)(ii) of the Act, and we intend to continue our work
examining potentially misvalued codes in these areas over the upcoming
years. As part of our current process, we identify potentially
misvalued codes for review, and request recommendations from the RUC
and other public commenters on revised work RVUs and direct PE inputs
for those codes. The RUC, through its own processes, also identifies
potentially misvalued codes for review. Through our public nomination
process for potentially misvalued codes established in the CY 2012 PFS
final rule with comment period, other individuals and stakeholder
groups submit nominations for review of potentially misvalued codes as
well.
Since CY 2009, as a part of the annual potentially misvalued code
review and Five-Year Review process, we have reviewed approximately
1,700 potentially misvalued codes to refine work RVUs and direct PE
inputs. We have assigned appropriate work RVUs and direct PE inputs for
these services as a result of these reviews. A more detailed discussion
of the extensive prior reviews of potentially misvalued codes is
included in the CY 2012 PFS final rule with comment period (76 FR 73052
through 73055). In the CY 2012 PFS final rule with comment period (76
FR 73055 through 73958), we finalized our policy to consolidate the
review of physician work and PE at the same time, and established a
process for the annual public nomination of potentially misvalued
services.
In the CY 2013 PFS final rule with comment period, we built upon
the work we began in CY 2009 to review potentially misvalued codes that
have not been reviewed since the implementation of the PFS (so-called
``Harvard-valued codes''). In CY 2009 (73 FR 38589), we requested
recommendations from the RUC to aid in our review of Harvard-valued
codes that had not yet been reviewed, focusing first on high-volume,
low intensity codes. In the fourth Five-Year Review (76 FR 32410), we
requested recommendations from the RUC to aid in our review of Harvard-
valued codes with annual utilization of greater than 30,000 services.
In the CY 2013 PFS final rule with comment period, we identified
specific Harvard-valued services with annual allowed charges that total
at least $10,000,000 as

[[Page 59500]]

potentially misvalued. In addition to the Harvard-valued codes, in the
CY 2013 PFS final rule with comment period we finalized for review a
list of potentially misvalued codes that have stand-alone PE (codes
with physician work and no listed work time and codes with no physician
work that have listed work time).
In the CY 2016 PFS final rule with comment period, we finalized for
review a list of potentially misvalued services, which included eight
codes in the neurostimulators analysis-programming family (CPT codes
95970-95982). We also finalized as potentially misvalued 103 codes
identified through our screen of high expenditure services across
specialties.
In the CY 2017 PFS final rule, we finalized for review a list of
potentially misvalued services, which included eight codes in the end-
stage renal disease home dialysis family (CPT codes 90963-90970). We
also finalized as potentially misvalued 19 codes identified through our
screen for 0-day global services that are typically billed with an
evaluation and management (E/M) service with modifier 25.
In the CY 2018 PFS final rule, we finalized arthrodesis of
sacroiliac joint (CPT code 27279) as potentially misvalued. Through the
use of comment solicitations with regard to specific codes, we also
examined the valuations of other services, in addition to, new
potentially misvalued code screens (82 FR 53017 through 53018).
3. CY 2019 Identification and Review of Potentially Misvalued Services
In the CY 2012 PFS final rule with comment period (76 FR 73058), we
finalized a process for the public to nominate potentially misvalued
codes. In the CY 2015 PFS final rule with comment period (79 FR 67606
through 67608), we modified this process whereby the public and
stakeholders may nominate potentially misvalued codes for review by
submitting the code with supporting documentation by February 10th of
each year. Supporting documentation for codes nominated for the annual
review of potentially misvalued codes may include the following:
Documentation in peer reviewed medical literature or other
reliable data that there have been changes in physician work due to one
or more of the following: Technique, knowledge and technology, patient
population, site-of-service, length of hospital stay, and work time.
An anomalous relationship between the code being proposed
for review and other codes.
Evidence that technology has changed physician work.
Analysis of other data on time and effort measures, such
as operating room logs or national and other representative databases.
Evidence that incorrect assumptions were made in the
previous valuation of the service, such as a misleading vignette,
survey, or flawed crosswalk assumptions in a previous evaluation.
Prices for certain high cost supplies or other direct PE
inputs that are used to determine PE RVUs are inaccurate and do not
reflect current information.
Analyses of work time, work RVU, or direct PE inputs using
other data sources (for example, VA, NSQIP, the STS National Database,
and the MIPS data).
National surveys of work time and intensity from
professional and management societies and organizations, such as
hospital associations.
We evaluate the supporting documentation submitted with the
nominated codes and assess whether the nominated codes appear to be
potentially misvalued codes appropriate for review under the annual
process. In the following year's PFS proposed rule, we publish the list
of nominated codes and indicate for each nominated code whether we
agree with its inclusion as a potentially misvalued code. The public
has the opportunity to comment on these and all other proposed
potentially misvalued codes. In that year's final rule, we finalize our
list of potentially misvalued codes.
a. Public Nominations
We received one submission that nominated several high-volume codes
for review under the potentially misvalued code initiative. In its
request, the submitter noted a systemic overvaluation of work RVUs in
certain procedures and tests based ``on a number of Government
Accountability Office (GAO) and the Medicare Payment Advisory
Commission (MedPAC) reports, media reports regarding time inflation of
specific services, and the January 19, 2017 Urban Institute report for
CMS.'' The submitter suggested that the times CMS assumes in estimating
work RVUs are inaccurate for procedures, especially due to substantial
overestimates of preservice and postservice time, including follow-up
inpatient and outpatient visits that do not take place. According to
the submitter, the time estimates for tests and some other procedures
are primarily overstated as part of the intraservice time. Furthermore,
the submitter stated that previous RUC reviews of these services did
not result in reductions in valuation that adequately reflected
reductions in surveyed times.
Based on these analyses, the submitter requested that the codes
listed in Table 11 be prioritized for review under the potentially
misvalued code initiative.

Table 11--Public Nominations Due to Overvaluation
------------------------------------------------------------------------
CPT code Short description
------------------------------------------------------------------------
27130............................. Total hip arthroplasty.
27447............................. Total knee arthroplasty.
43239............................. Egd biopsy single/multiple.
45385............................. Colonoscopy w/lesion removal.
70450............................. CT head w/o contrast.
93000............................. Electrocardiogram complete.
93306............................. Tte w/doppler complete.
------------------------------------------------------------------------

Another submitter requested that CPT codes 92992 (Atrial septectomy
or septostomy; transvenous method, balloon (e.g., Rashkind type)
(includes cardiac catheterization)) and 92993 (Atrial septectomy or
septostomy; blade method (Park septostomy) (includes cardiac
catheterization)) be reviewed under the potentially misvalued code
initiative in order to establish national RVU values for these services
under the MPFS. These codes are currently priced by the Medicare
Administrative Contractors (MACs).
We received several comments with regard to the nomination of
several high-volume codes for review under the potentially misvalued
code initiative.
Comment: One commenter stated that specific details of the
nomination of the seven high-volume codes were not provided in the CY
2019 PFS proposed rule. Several other commenters, including the RUC,
expressed concern that the source of the nomination of the seven high-
volume codes and its entire nomination letter was not made available.
These commenters requested that CMS provide greater transparency and
publicly provide all nomination requests identifying potentially
misvalued codes.
Response: We believe that we summarized the contents of the public
nomination letter and provided the rationale in the CY 2019 PFS
proposed rule with enough detail for commenters to comment
substantively and provide supporting documentation or data to rebut the
suggestion that these codes are potentially misvalued. We recognize the
importance of transparency and note that under the public nomination
process that was established in CY 2012 rulemaking, the first
opportunity for the public to nominate codes was during the 60-day
comment period for the CY

[[Page 59501]]

2012 final rule with comment period; therefore, public nominations were
received via submission to www.regulations.gov. In the CY 2015 final
rule with comment period (79 FR 67606 through 67608), we finalized a
modified process for identifying potentially misvalued codes (fully
effective in CY 2017), where we established a new deadline of February
10th for receipt of public nominations for potentially misvalued codes
to be considered for inclusion in the proposed rule. Although
stakeholders often include public nominations of misvalued codes for
consideration in a subsequent year's rulemaking as part of their
comments on a current year's proposed rule, the public and stakeholders
may nominate potentially misvalued codes for review by submitting the
code with supporting documentation to CMS by February 10th of each
year. In the future, public nominations that CMS receives by the
February 10th deadline will be made available in the form of a public
use file with the proposed rule, in the downloads section on the CMS
website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-
Payment/PhysicianFeeSched/. We remind submitters that any information
that might be considered proprietary or confidential should not be
included. Additionally, we have included the submission that nominated
these high-volume codes for review as potentially misvalued as a public
use file for the CY 2019 PFS final rule.
Comment: One commenter stated that because CMS did not include
these publicly nominated codes in Table 13 of the proposed rule, it
does not appear that CMS has agreed with the commenter on the need to
revisit these codes. Another commenter stated that CMS did not provide
guidance on whether these nominated codes would be considered for
revaluation or retained at their current value.
Response: We clarify that the codes for which we received public
nominations as potentially misvalued were not included in Table 13 of
the proposed rule because that table contains a list of codes for which
we proposed work RVUs for CY 2019 (the list does not include codes for
which we received nominations discussed in the proposed rule for
consideration as potentially misvalued). As previously indicated, in
the proposed rule we publish the list of codes nominated as potentially
misvalued, which allows the public the opportunity to comment on these
codes; then, in the final rule, we finalize our list of potentially
misvalued codes. No new valuations were proposed for these codes in the
CY 2019 PFS proposed rule. Any revaluation of these codes would be
proposed in future rulemaking.
Comment: One commenter stated that the codes in Table 8 in the
proposed rule and their respective code families should be prioritized
for review as potentially misvalued. The commenter suggested revisiting
two recent efforts funded by CMS, reports by Urban Institute and RAND
Corporation (https://www.urban.org/sites/default/files/publication/
87771/2001123-collecting-empirical-physician-time-data-piloting-
approach-for-validating-work-relative-value-units_1.pdf, and, https://
www.rand.org/content/dam/rand/pubs/research_reports/RR600/RR662/
RAND_RR662.pdf), for prioritization of codes for review to expand the
misvalued codes initiative list. The commenter referenced a June 2018
MedPAC report that stated that CMS' review of potentially misvalued
codes has not addressed services that account for a substantial share
of fee schedule spending and is hampered by the lack of current,
accurate, and objective data on clinician work time and practice
expenses. Consequently, according to the MedPAC report, work RVUs for
procedures, imaging, and tests are systemically overvalued relative to
other services, such as ambulatory evaluation and management (E/M)
services.
Response: We appreciate the commenters' recommendations for
expanding the misvalued codes list. We will consider whether to address
these suggestions in future rulemaking.
Comment: One commenter recommended that additional research be
conducted on the analytic products available that could be used to
create transparency into the RUC process and allow for greater external
participation in misvalued cost evaluation. The commenter also stated
that CMS should reconsider reliance on the RUC altogether given the
inherent conflicts of interest in the RUC-based process.
Response: We acknowledge that the RUC provides critically important
information that factors into our review process. However, our review
of recommended work RVUs and time inputs is also informed by review of
various alternate sources of information, in addition to the RUC.
Examples of these alternate sources of information include information
provided by other public commenters, Medicare claims data, comparative
databases, medical literature, as well as consultation with other
physicians and healthcare professionals within CMS and the federal
government. We also reiterate that we continue to be open to reviewing
additional and supplemental sources of data furnished by stakeholders,
and providing such information to CMS is not limited to the public
nomination process for potentially misvalued codes. We encourage
stakeholders to continue to provide such information for our
consideration in establishing work RVUs.
Comment: One commenter stated concerns with CMS' use of a non-
relative measuring approach for the seven codes nominated for review
when generally the RUC-valued and CMS-approved codes are based on the
concept of relativity. The commenter stated that using such an
inconsistent approach on select codes will potentially cause disruption
and instability in code valuations. The commenter also stated that
determining reimbursement in value-based care delivery models must rely
on the carefully cultivated RUC process for fairness and
accountability.
Response: We are unclear about the commenter's claim that CMS is
using a non-relative measuring approach for the seven high volume codes
that have been nominated as potentially misvalued. We did not propose a
valuation for the nominated codes, nor did we propose to use a non-
relative measuring approach. Rather, as part of our statutory
obligation to identify and review potentially misvalued codes, we
implemented an annual process whereby the public can nominate
potentially misvalued codes with supporting documentation; we then
publish the list of nominated codes and the public has the opportunity
to comment on these nominations. We continue to maintain that
adjustments to work RVUs should be based on the resources involved with
each procedure or service, and reiterate that our review of work RVUs
and time inputs utilizes information from various resources, including
the RUC. We continue to seek information on the best sources of
objective, routinely-updated, auditable, and robust data regarding the
resource costs of furnishing PFS services.
Comment: Several commenters stated that CPT codes 27130 and 27447
should not be considered potentially misvalued and do not warrant any
further action because the current valuation for the codes was
established after review by the RUC and CMS in 2013, and since that
time there are no new data to indicate a change in the work of
performing the procedure or the number of post-operative follow up
visits. Another commenter stated that CMS should not subject
professions to code

[[Page 59502]]

valuations and analysis so frequently, and that doing so calls into
question the validity of the RUC process in the first place.
Response: We do not agree that recent review of a code should
preclude it from being considered as potentially misvalued, nor that it
calls into question the validity of the RUC process. We have a
responsibility to identify and review potentially misvalued codes, and
believe there is value in consistent and routine review of high-volume
services, particularly considering that a minor adjustment to the work
RVU of a high-volume code may have a significant dollar impact. We also
note that review of high-volume services does not need to be predicated
on the suspicion of overvaluation.
Comment: One commenter stated that if CMS decides to reexamine
these nominated codes in the future, then the agency should provide
ample opportunity for public comments, and in the event of such review,
CMS should consider supplemental sources of information, including
hospital anesthesia time in addition to any RUC recommendations in
order to support accurate valuations of these procedures.
Response: Any revaluations of these codes would be undertaken
through notice and comment rulemaking. Notice and comment rulemaking
provides for an open process whereby we welcome input from all
interested parties, and we encourage commenters to provide feedback
including supplemental sources of information regarding potentially
misvalued codes, as well as input on our annual proposed valuations.
Comment: One commenter disagreed that CPT codes 43239 and 45385 are
misvalued and stated that while the Urban Institute report provides
insights into potential flaws in the RUC survey process, it should not
be considered proof that these codes are overvalued. The commenter
stated that these code valuations were recently revised, and the RUC
survey responses from gastroenterologists informed revisions to the
work RVUs for both services. The commenter stated that for CPT code
43239, CMS finalized work RVUs that were less than the RUC's
recommended work RVUs, and for CPT code 45385, CMS finalized the RUC-
recommended work RVUs, which were lower than the work RVUs prior to
reevaluation. Therefore, the commenter stated that CMS should reject
the nominations of these codes as potentially misvalued.
Response: We note that the nomination referenced the Urban
Institute report as only one of the sources regarding the issue of time
inflation of specific services. Additionally, as previously indicated,
we do not agree that recent review of a code should preclude it from
being considered as potentially misvalued. We believe there is value in
consistent and routine review of high-volume services, particularly
considering that a minor adjustment to the work RVU of a high-volume
code may have a significant dollar impact. Therefore, we do not agree
that we should reject nominations of these codes as potentially
misvalued because they were previously reviewed and refinements were
made.
Comment: A few commenters stated that the current work RVU
valuation of 0.85 for CPT code 70450 is inadequate. The commenters
stated that the level of effort associated with CPT code 70450
increased between the time the code was originally valued and the 2012
survey, and this increase continued through 2016. The commenters stated
that over time, advances in technology led to many more images being
created than existed historically. The commenters also stated that
volume acquisitions, a CT scan technique that allows for multiple two-
dimensional images, has resulted in thinner reconstructions and
effortless multiplanar reformats, and other technological advancements
have increased the amount of professional work associated with
interpreting a non-contrast head CT and should be considered in the
work RVU. The commenters expressed concern that the nomination by a
single entity threatens the integrity of how physician services are
valued generally.
Response: We disagree with the commenter that a nomination by a
single entity threatens the integrity of how physician services are
valued generally, and reiterate that a public nomination process was
established through rulemaking as a way for the public and stakeholders
to nominate potentially misvalued codes for consideration. Any future
proposed valuations of specific codes are open for public comment, and
we encourage stakeholders to submit data that would indicate that the
current valuation is insufficient.
Comment: One commenter stated that with regard to CPT code 70450,
the times prior to survey were CMS/other times and were not subdivided
into pre-service, intra-service, and post-service categories.
Therefore, the commenter stated that drawing comparisons between prior
RUC database times and the surveyed times is invalid because the source
of the prior RUC database times are unknown and completely different
from the surveyed times. The commenter also stated that selecting as
potentially misvalued only certain CPT codes that have undergone the
RUC process with validated surveys is not a rational approach because
if the times assumed based on the RUC approved survey data are invalid
for these codes, they should be invalid for the entire fee schedule so
that consistent methodology is applied to all CPT codes.
Response: We typically rely on RUC survey values because we believe
they are the closest to accurate values, as they are the best data
available in some cases. Although we do not agree that we should not
consider comparisons of RUC database times to the newly surveyed times
as described by the commenter, on a case-by-case basis we can consider
the existence of previous inaccuracies. However, we also note that
previous valuations established based on those inaccuracies would also
indicate that the payments would have been inaccurate as well. The goal
of the identification and review of potentially misvalued services is
to facilitate accurate payment for PFS services. We also disagree with
the commenter's characterization that selecting codes that have
undergone the RUC process with validated surveys is not rational, and
note that just because a code has been reviewed by the RUC does not
preclude it from being identified and/or publically nominated as
potentially misvalued.
Comment: With regard to CPT codes 93000 and 93306, one commenter
stated that while the Urban Institute report concludes that the
intraservice time to interpret an electrocardiogram is 6 seconds,
practitioners who furnish the service do not believe it is possible to
completely interpret a study so quickly. The commenter expressed
concern about the large emphasis placed on service time by CMS and some
stakeholders when it comes to valuation. The commenter suggested that
frequent reviews of long-established mature services like
electrocardiography and echocardiography will produce two outcomes--the
inputs will remain the same or circumstances at some point will align
such that it appears they take less time, which will open the window
for payers to try to reduce payment for services that have not actually
changed, and eventually these reductive re-valuations produce
underpayment. A few commenters stated that CPT code 93306 was recently
reviewed and valued in CY 2018. One commenter stated that the current
valuation is reflective of numerous accreditation body requirements
that were implemented since the service was last valued in 2007, which
increased the

[[Page 59503]]

work required per study. The commenter stated that the Urban Institute
report should not be considered proof that the CPT code is overvalued,
and given the recent RUC review of this service, CMS' acceptance of the
RUC recommendation, and no change in the physician work of performing
the service in the past year, this code should not be included in the
potentially misvalued codes list.
Response: We reiterate that it is our practice to consider all
elements of the relative work when we are reviewing and determining
work RVU valuations. Additionally, our review of recommended work RVUs
and time inputs generally includes review of various sources such as
information provided by the RUC, and other public commenters, medical
literature, and comparative databases. As previously stated, we believe
there is great value in consistent and routine review of high-volume
services. Additionally, as previously indicated, we do not agree that
recent review of a code should preclude it from being considered as
potentially misvalued, and therefore, do not agree that CMS should not
include a code in the list of potentially misvalued services because it
was previously reviewed.
Comment: One commenter disagreed that the time allocated to CPT
code 93306 is overstated. The commenter stated that the Intersocietal
Accreditation Commission for Echocardiography Guidelines regarding time
standards indicated that more time is necessary from patient encounter
to departure than is stipulated in the CMS time file. The commenter
also stated there is more and more information being gathered with the
introduction of technology that is labor and time intensive. The
commenter suggested that if anything is revised, CMS times should be
increased, not decreased.
Response: We reiterate that we are interested in receiving
resource-based data from stakeholders and not just the RUC and we
encourage stakeholders to submit data that would indicate that the
current valuations are insufficient.
Although we appreciate the comments that were received regarding
the seven high-volume codes, we believe that the nominator presented
some concerns that have merit, such as the observation that in many
cases time is reduced substantially but the work RVU only minimally,
which results in an implied increase in the intensity of work that does
not appear to be valid, and ultimately creates work intensity anomalies
that are difficult to defend, and further review of these high-volume
codes is the best way to determine the validity of the concerns
articulated by the submitter. Therefore, we are adding CPT codes 27130,
27447, 43239, 45385, 70450, 93000, and 93306 to the list of potentially
misvalued codes and anticipate reviewing recommendations from the RUC
and other stakeholders. We reiterate that we do not believe that the
inclusion of a code on a potentially misvalued code list necessarily
means that a particular code is misvalued. Instead, the list is
intended to prioritize codes to be reviewed under the misvalued code
initiative.
In addition to comments on the nomination of the seven high-volume
codes, we also received comments on the nomination of two contractor-
priced codes for review under the potentially misvalued code
initiative.
Comment: We received a few comments with regard to CPT codes 92992
and 92993, which were requested for review under the potentially
misvalued code initiative in order to establish national RVU values for
these services under the PFS. One of the commenters, the RUC, stated
that these contractor-priced services, which are typically performed on
children, would be discussed at the October 2018 Relativity Assessment
Workgroup meeting.
Response: We appreciate the information from the RUC on their plans
to discuss these codes. Given the plans by the RUC to consider CPT
codes 92992 and 92993 we will wait for the RUC's review and will not
add these codes to the list of potentially misvalued codes.
b. Update on the Global Surgery Data Collection
Payment for postoperative care is currently bundled within 10 or 90
days after many surgical procedures. Historically, we have not
collected data on how many postoperative visits are actually performed
during the global period. Section 523 of the MACRA added a new
paragraph 1848(c)(8) to the Act, and section 1848(c)(8)(B) required CMS
to use notice and comment rulemaking to implement a process to collect
data on the number and level of postoperative visits and use these data
to assess the accuracy of global surgical package valuation. In the CY
2017 PFS final rule, we adopted a policy to collect postoperative visit
data. Beginning July 1, 2017, we required practitioners in groups with
10 or more practitioners in nine states (Florida, Kentucky, Louisiana,
Nevada, New Jersey, North Dakota, Ohio, Oregon, and Rhode Island) to
use the no-pay CPT code 99024 (Postoperative follow-up visit, normally
included in the surgical package, to indicate that an E/M service was
performed during a postoperative period for a reason(s) related to the
original procedure) to report postoperative visits. Practitioners who
only practice in groups with fewer than 10 practitioners are exempted
from required reporting, but are encouraged to report if feasible. The
293 procedures for which reporting is required are those furnished by
more than 100 practitioners, and either are nationally furnished more
than 10,000 times annually or have more than $10 million in annual
allowed charges. A list of the procedures for which reporting is
required is updated annually to reflect any coding changes and is
posted on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-
for-Service-Payment/PhysicianFeeSched/Global-Surgery-Data-
Collection-.html.
In these nine states, from July 1, 2017 through December 31, 2017,
there were 990,581 postoperative visits reported using CPT code 99024.
Of the 32,573 practitioners who furnished at least one of the 293
procedures during this period and who, based on Tax Identification
Numbers in claims data, were likely to meet the practice size
threshold, only 45 percent reported one or more visit using CPT code
99024 during this 6-month period. The share of practitioners who
reported any CPT code 99024 claims varied by specialty. Among surgical
oncology, hand surgery, and orthopedic surgeons, reporting rates were
92, 90, and 87 percent, respectively. In contrast, the reporting rate
for emergency medicine physicians was 4 percent.
Among 10-day global procedures performed from July 1, 2017 through
December 31, 2017, where it is possible to clearly match postoperative
visits to specific procedures, only 4 percent had one or more matched
visit reported with CPT code 99024. The percentage of 10-day global
procedures with a matched visit reported with CPT code 99024 varied by
specialty. Among procedures with 10-day global periods performed by
hand surgeons, critical care, and obstetrics/gynecology, 44, 36, and 23
percent, respectively, of procedures had a matched visit reported using
CPT code 99024. In contrast, less than 5 percent of 10-day global
procedures performed by many other specialties had a matched visit
reported using CPT code 99024. Among 90-day global procedures performed
from July 1, 2017 through December 31, 2017, where it is possible to
clearly match postoperative visits to specific procedures, 67 percent
had one or more matched visits reported using CPT code 99024.
In the CY 2019 PFS proposed rule, we suggested one potential
explanation for

[[Page 59504]]

these findings is that many practitioners are not consistently
reporting postoperative visits using CPT code 99024. We sought comment
on how to encourage reporting to ensure the validity of the data
without imposing undue burden. Specifically, we sought comment on
whether we need to do more to make practitioners aware of their
obligation and whether we should consider implementing an enforcement
mechanism.
We sought comment on several other issues. Given the very small
number of postoperative visits reported using CPT code 99024 during 10-
day global periods, we sought comment on whether or not it might be
reasonable to assume that many visits included in the valuation of 10-
day global packages are not being furnished, or whether there are
alternative explanations for what could be a significant level of
underreporting of postoperative visits. Alternatively, we sought
comment on whether it is possible that some or all of the postoperative
visits are occurring after the global period ends and are, therefore,
reported and paid separately.
We sought comment on whether we should consider requiring use of
modifiers -54 and -55 in cases where the surgeon does not expect to
perform the postoperative visits, regardless of whether or not the
transfer of care is formalized. We also sought comment on the best
approach to 10-day global codes for which the preliminary data suggest
that postoperative visits are rarely performed by the practitioner
reporting the global code and whether we should consider changing the
global period and reviewing the code valuation.
The following is a summary of the comments we received on
collecting data on global surgery and reporting.
Comment: The majority of commenters, including the RUC, noted that
more time was needed for physicians to become aware of reporting and
prepare for reporting. Moreover, they opposed implementing an
enforcement mechanism, but supported more efforts by CMS to make
physicians aware of the requirement. A few commenters objected to
reporting and noted that CMS had complied with the statute. MedPAC,
which supported converting all 10- and 90-day global codes to 0-day
global codes and revaluing these codes as 0-day codes, suggested that
these findings are consistent with the OIG's three studies that showed
post-operative visits were not occurring at the rate that we estimated.
MedPAC noted support for converting all codes with 10- and 90-day
global periods to 0-day global codes and revaluing these codes as 0-day
codes, most other commenters were opposed to creating 0-day global
services out of 10-day global services. Of those who commented on
reporting of post-operative visits, most suggested that improving
reporting of these visits is essential if the data is to be used to
improve the accuracy of the existing codes.
Response: We will evaluate the public comments received and
consider whether to propose action at a future date. For the comment
calling for additional efforts to make physicians aware of the
requirement, we sent a letter describing the requirement to
practitioners who are required to report in the 9 affected states and
we plan to send another such letter to these practitioners. We will
also consider other actions to make sure affected practitioners are
aware of the requirement.

F. Radiologist Assistants

In accordance with Sec. 410.32(b)(3), except as otherwise
provided, all diagnostic X-ray and other diagnostic tests covered under
section 1861(s)(3) of the Act and payable under the PFS must be
furnished under at least a general level of physician supervision as
defined in paragraph (b)(3)(i) of that regulation. In addition, some of
these tests require either direct or personal supervision as defined in
paragraphs (b)(3)(ii) or (iii) of Sec. 410.32, respectively. We list
the required minimum physician supervision level for each diagnostic X-
ray and other diagnostic test service along with the codes and relative
values for these services in the PFS Relative Value File, which is
posted on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-
for-Service-Payment/PhysicianFeeSched/PFS-Relative-Value-Files.html.
For most diagnostic imaging procedures, this required physician
supervision level applies only to the technical component (TC) of the
procedure.
In response to the Request for Information on CMS Flexibilities and
Efficiencies (RFI) that was issued in the CY 2018 PFS proposed rule (82
FR 34172 through 34173), many commenters recommended that we revise the
physician supervision requirements at Sec. 410.32(b) for diagnostic
tests with a focus on those that are typically furnished by a
radiologist assistant (RA) under the supervision of a physician.
Specifically, the commenters stated that all diagnostic tests, when
performed by RAs, can be furnished under direct supervision rather than
personal supervision of a physician, and that we should revise the
Medicare supervision requirements so that when RAs conduct diagnostic
imaging tests that would otherwise require personal supervision, they
only need to do so under direct supervision. In addition to increasing
efficiency, stakeholders suggested that the current supervision
requirements for certain diagnostic imaging services unduly restrict
RAs from conducting tests that they are permitted to do under current
law in many states.
After consideration of these comments on the RFI, as well as
information provided by stakeholders, we proposed to revise our
regulations to specify that all diagnostic imaging tests may be
furnished under the direct supervision of a physician when performed by
an RA in accordance with state law and state scope of practice rules.
Stakeholders representing the radiology community have provided us with
information showing that the RA designation includes registered
radiologist assistants (RRAs) who are certified by The American
Registry of Radiologic Technologists, and radiology practitioner
assistants (RPAs) who are certified by the Certification Board for
Radiology Practitioner Assistants. We proposed to revise our regulation
at Sec. 410.32 to add a new paragraph (b)(4) to state that diagnostic
tests performed by an RRA or an RPA require only a direct level of
physician supervision, when permitted by state law and state scope of
practice regulations. We noted that for diagnostic imaging tests
requiring a general level of physician supervision, this proposal would
not change the level of physician supervision to direct supervision.
Otherwise, the diagnostic imaging tests must be performed as specified
elsewhere under Sec. 410.32(b). We based this proposal on
recommendations from the practitioner community that included specific
recommendations on how to implement the change. Representatives of the
practitioner community submitted information on the education and
clinical experience of RAs, which we took into consideration in
determining whether the proposal would pose a significant risk to
patient safety, and we determined that it would not. In addition, we
considered information provided by stakeholders that indicated that 28
states have statutes or regulations that recognize RAs, and these
states have general or direct supervision requirements for RAs.
Comment: Many commenters supported our proposed changes to the
regulations and stated that they agreed that diagnostic tests performed
by RAs be performed under at most direct supervision rather than
personal

[[Page 59505]]

supervision where permitted by state law and state scope of practice
regulations. According to these commenters, the change would allow for
greater efficiency, improved patient access, more dedicated time with
patients, increased quality of care, and increased patient
satisfaction.
Response: We appreciate the comments received in support of this
proposal. As discussed in the proposed rule, for diagnostic imaging
tests requiring a general level of physician supervision, we are not
changing the level of physician supervision to direct supervision.
Otherwise, the diagnostic imaging tests must be performed as specified
elsewhere under Sec. 410.32(b). In order to provide further clarity,
we are modifying the regulation to clarify that diagnostic tests
performed by an RRA who is certified and registered by the American
Registry of Radiologic Technologists or an RPA who is certified by the
Certification Board for Radiology Practitioner Assistants, and that
would otherwise require a personal level of supervision as specified in
Sec. 410.32(b)(3), may be furnished under a direct level of physician
supervision to the extent permitted by state law and state scope of
practice regulations.
Comment: Many commenters requested that CMS ensure that the
proposed policy be effective January 1, 2019 by providing any necessary
administrative guidance. Many commenters requested that CMS clarify in
its final regulation that all services within the RA scope of practice,
including procedures, may be performed under direct supervision.
Response: In implementing these changes to the regulation, we will
be updating guidance contained in Pub. 100-04, Medicare Claims
Processing Manual, Chapter 23 (available on the CMS website at https://
www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/internet-Only-
Manuals-IOMs-Items/Pub100_23.html). Medicare supervision rules are only
directly applicable to diagnostic tests, not procedures. We note that
for procedures provided by auxiliary personnel (such as a radiologist
assistant) incident to the services of the billing physician or
practitioner, Medicare generally requires direct supervision in
accordance with the regulation at Sec. 410.26(b)(5).
Comment: One commenter suggested that CMS require verbal assurances
to patients as to the credentials of the health care professional
conducting the procedure, when the procedure is performed by an RA. The
commenter stated that requiring this verbal assurance will minimize
confusion about who the physician is when there are multiple
individuals furnishing the procedure.
Response: We believe such a requirement would be unwarranted and
overly restrictive. We do not generally require practitioners to
provide such assurances to Medicare beneficiaries, nor did we propose
such a requirement in the proposed rule.
Comment: Several commenters suggested that CMS should
operationalize the proposal starting January 1, 2019 by using a
radiologist supervision indicator to recognize the RA under direct
supervision rather than personal supervision when they provide Medicare
services under their state scope of practice. These commenters
requested the creation of a new supervision indicator that would be
applied to specific codes and would indicate that the procedure may be
performed under the direct supervision of a radiologist when performed
by an RRA who is certified by The American Registry of Radiologic
Technologists, and an RPA who is certified by the Certification Board
for Radiology Practitioner Assistants.
Response: Our approach to effectuating this policy change was based
on recommendations we received from the practitioner community. Under
this approach, we allow for direct supervision for tests performed in
part by an RA, which avoids the need to identify which CPT codes would
be appropriate for inclusion under a new indicator. We believe our
approach offers the most flexibility, ease of implementation, and
subsequently reduces burden for billing practitioners and radiologist
assistants.
After consideration of the public comments received, we are
finalizing, with refinements for further clarity, our proposed
revisions to Sec. 410.32, by adding a new paragraph (b)(4) that states
that diagnostic tests that are performed by a registered radiologist
assistant (RRA) who is certified and registered by the American
Registry of Radiologic Technologists or a radiology practitioner
assistant (RPA) who is certified by the Certification Board for
Radiology Practitioner Assistants, and that would otherwise require a
personal level of supervision as specified in paragraph (3), may be
furnished under a direct level of physician supervision to the extent
permitted by state law and state scope of practice regulations.

G. Payment Rates Under the Medicare PFS for Nonexcepted Items and
Services Furnished by Nonexcepted Off-Campus Provider-Based Departments
of a Hospital

1. Background
Sections 1833(t)(1)(B)(v) and (t)(21) of the Act require that
certain items and services furnished by certain off-campus provider-
based departments (PBDs) (collectively referenced here as nonexcepted
items and services furnished by nonexcepted off-campus PBDs) shall not
be considered covered outpatient department (OPD) services for purposes
of payment under the Hospital Outpatient Prospective Payment System
(OPPS), and payment for those nonexcepted items and services furnished
on or after January 1, 2017 shall be made under the applicable payment
system under Medicare Part B if the requirements for such payment are
otherwise met. These requirements were enacted in section 603 of the
Bipartisan Budget Act of 2015 (Pub. L. 114-74, enacted November 2,
2015).
In the CY 2017 OPPS/Ambulatory Surgical Center (ASC) final rule
with comment period (81 FR 79699 through 79719), we established several
policies and provisions to define the scope of nonexcepted items and
services in nonexcepted off-campus PBDs. We also finalized the PFS as
the applicable payment system for most nonexcepted items and services
furnished by nonexcepted off-campus PBDs. At the same time, we issued
an interim final rule with comment period (81 FR 79720 through 79729)
in which we established payment policies under the PFS for nonexcepted
items and services furnished on or after January 1, 2017. In the
following paragraphs, we summarize the policies that we adopted for CY
2017 and CY 2018. We also summarize proposals for CY 2019, respond to
public comments, and finalize payment policies for CY 2019. For issues
related to the excepted status of off-campus PBDs or the excepted
status of items and services, please see the CY 2019 OPPS/ASC final
rule.
2. Payment Mechanism
In establishing the PFS as the applicable payment system for most
nonexcepted items and services in nonexcepted off-campus PBDs under
sections 1833(t)(1)(B)(v) and (t)(21) of the Act, we recognized that
there was no technological capability, at least in the near term, to
allow off-campus PBDs to bill under the PFS for those nonexcepted items
and services. Off-campus PBDs bill under the OPPS for their services on
an institutional claim,

[[Page 59506]]

while physicians and other suppliers bill under the PFS on a
practitioner claim. The two systems that process these different types
of claims, the Fiscal Intermediary Standard System (FISS) and the
Multi-Carrier System (MCS) system, respectively, were not designed to
accept or process claims of a different type. To permit an off-campus
PBD to bill directly under a different payment system than the OPPS
would have required significant changes to these complex systems as
well as other systems involved in the processing of Medicare Part B
claims. Consequently, we proposed and finalized a policy for CY 2017
and CY 2018 in which nonexcepted off-campus PBDs continue to bill for
nonexcepted items and services on the institutional claim utilizing a
new claim line modifier ``PN'' to indicate that an item or service is a
nonexcepted item or service.
We implemented requirements under section 1833(t)(1)(B) of the Act
for CY 2017 and CY 2018 by applying an overall downward scaling factor,
called the PFS Relativity Adjuster to payments for nonexcepted items
and services furnished in nonexcepted off-campus PBDs. The PFS
Relativity Adjuster generally reflects the average (weighted by claim
line volume times rate) of the site-specific rate under the PFS
compared to the rate under the OPPS (weighted by claim line volume
times rate) for nonexcepted items and services furnished in nonexcepted
off-campus PBDs. As we have discussed extensively in prior rulemaking
(81 FR 97920 through 97929 and 82 FR 53021), we established a new set
of site-specific payment rates under the PFS that reflect the relative
resource cost of furnishing the technical component (TC) of services
furnished in nonexcepted off-campus PBDs. For the majority of HCPCS
codes, these rates are based on either (1) the difference between the
PFS nonfacility payment rate and the PFS facility rate, (2) the TC, or
(3) in instances where payment would have been made only to the
facility or to the physician, the full nonfacility rate. The PFS
Relativity Adjuster refers to the percentage of the OPPS payment amount
paid under the PFS for a nonexcepted item or service to the nonexcepted
off-campus PBD.
To operationalize the PFS Relativity Adjuster as a mechanism to pay
for nonexcepted items and services furnished by nonexcepted off-campus
PBDs, we adopted the packaging payment rates and multiple procedure
payment reduction (MPPR) percentage that applies under the OPPS. We
also incorporated the claims processing logic that is used for payments
under the OPPS for comprehensive Ambulatory Payment Classifications (C-
APCs), conditionally and unconditionally packaged items and services,
and major procedures. As we noted in the CY 2017 PFS final rule (82 FR
53024), we believe that this maintains the integrity of the cost-
specific relativity of current payments under the OPPS compared with
those under the PFS.
In CY 2017, we implemented a PFS Relativity Adjuster of 50 percent
of the OPPS rate for nonexcepted items and services furnished in
nonexcepted off-campus PBDs. For a detailed explanation of how we
developed the PFS Relativity Adjuster of 50 percent for CY 2017,
including assumptions and exclusions, we refer readers to the CY 2017
OPPS/ASC interim final rule with comment period (81 FR 79720 through
79729). Beginning for CY 2018, we adopted a PFS Relativity Adjuster of
40 percent of the OPPS rate. For a detailed explanation of how we
developed the PFS Relativity Adjuster of 40 percent, we refer readers
to the CY 2018 PFS final rule (82 FR 53019 through 53042). A brief
overview of the general approach we took for CY 2018 and how it differs
from the proposal for CY 2019 appears in this section.
3. The PFS Relativity Adjuster
The PFS Relativity Adjuster reflects the overall relativity of the
applicable payment rate for nonexcepted items and services furnished in
nonexcepted off-campus PBDs under the PFS compared with the rate under
the OPPS. To develop the PFS Relativity Adjuster for CY 2017, we did
not have all of the claims data needed to identify the mix of items and
services that would be billed using the ``PN'' modifier. Instead, we
analyzed hospital outpatient claims data from January 1 through August
25, 2016, that contained the ``PO'' modifier, which was a new mandatory
reporting requirement for CY 2016 for claims that were billed by an
off-campus department of a hospital. We limited our analysis to those
claims billed on the 13X Type of Bill because those claims were used
for Medicare Part B billing under the OPPS. We then identified the 25
most frequently billed major codes that were billed by claim line; that
is, items and services that were separately payable or conditionally
packaged. Specifically, we restricted our analysis to codes with OPPS
status indicators (SI) ``J1'', ``J2'', ``Q1'', ``Q2'', ``Q3'', ``S'',
``T'', or ``V''. The most frequently billed service with the ``PO''
modifier in CY 2016 was described by HCPCS code G0463 (Hospital
outpatient clinic visit for the assessment and management of a
patient), which, in CY 2016, was paid under APC 5012 at a rate of
$102.12; the total number of claim lines for this service was
approximately 6.7 million as of August 2016. Under the PFS, there are
10 CPT codes describing different levels of office visits for new and
established payments. We compared the payment rate under OPPS for HCPCS
code G0463 ($102.12) to the average of the difference between the
nonfacility and facility rates for CPT code 99213 (Level III office
visit for an established patient) and CPT code 99214 (Level IV office
visit for an established patient) in CY 2016 and found that the
relative payment difference was approximately 22 percent. We did not
include HCPCS code G0463 in our calculation of the PFS Relativity
Adjuster for CY 2017 because we were concerned that there was no
single, directly comparable code under the PFS. As we stated in the CY
2017 PFS final rule (81 FR 79723), we wanted to mitigate the risk of
underestimating the overall relativity between the PFS and OPPS rates.
From the remaining top 24 most frequently billed codes, we excluded
HCPCS code 36591 (Collection of blood specimen from a completely
implantable venous access device) because, under PFS policies, the
service was only separately payable under the PFS when no other code
was on the claim. We also removed HCPCS code G0009 (Administration of
Pneumococcal Vaccine) because there was no payment for this code under
the PFS. For the remaining top 22 codes furnished with the ``PO''
modifier in CY 2016, the average (weighted by claim line volume times
rate) of the nonfacility payment rate estimate for the PFS compared to
the estimate for the OPPS was 45 percent. We indicated that, because of
our inability to estimate the effect of the packaging difference
between the OPPS and the PFS, we would assume a 5 percentage point
adjustment upward from the calculated amount of 45 percent; therefore,
we established the PFS Relativity Adjuster of 50 percent for CY 2017.
In establishing the PFS Relativity Adjuster for CY 2018, we still
did not have claims data for items and services furnished reported with
a ``PN'' modifier. However, we updated the list of the 25 most
frequently billed HCPCS codes using an entire year (CY 2016) of claims
data for services submitted with a ``PO'' modifier and we updated the
corresponding utilization weights for the codes used in the analysis.
The order and composition of the top 25 separately payable HCPCS codes,
based on the full year of claims from CY 2016

[[Page 59507]]

submitted with the ``PO'' modifier, changed minimally from the codes we
used in our original analysis for the CY 2017 OPPS/ASC interim final
rule with comment period. For a detailed list of the HCPCS codes we
used in calculating the CY 2017 PFS Relativity Adjuster and the CY 2018
PFS Relativity Adjuster, we refer readers to the CY 2018 PFS final rule
(82 FR 53030 through 53031). As noted earlier, in establishing the PFS
Relativity Adjuster of 50 percent for CY 2017, we did not include in
the weighted average code comparison, the relative rate for the most
frequently billed service furnished in off-campus PBDs, HCPCS code
G0463 (Hospital outpatient clinic visit for assessment and management
of a patient), in part to ensure that we were not underestimating the
overall relativity between the PFS and the OPPS. In contrast, in the CY
2018 PFS final rule, we stated that our objective for CY 2018 was to
ensure that we did not overestimate the appropriate overall payment
relativity, and that the payment made to nonexcepted off-campus PBDs
better aligned with the services that are most frequently furnished in
the setting. Therefore, in addition to using updated claims data, we
revised the PFS Relativity Adjuster to incorporate the relative payment
rate for HCPCS code G0463 into our analysis. We followed all other
exclusions and assumptions that were made in calculating the CY 2017
PFS Relativity Adjuster. Our analysis resulted in a 35 percent relative
difference in payment rates. Similar to our stated rationale in the CY
2017 PFS final rule, we increased the PFS Relativity Adjuster to 40
percent, acknowledging the difficulty of estimating the effect of the
packaging differences between the OPPS and the PFS.
4. Payment Policies for CY 2019
In prior rulemaking, we stated our expectation that our general
approach of adjusting OPPS payments using a single scaling factor, the
PFS Relativity Adjuster, would continue to be an appropriate payment
mechanism to implement provisions of section 603 of the Bipartisan
Budget Act of 2015, and would remain in place until we are able to
establish code-specific reductions that represent the TC of services
furnished under the PFS or until we are able to implement system
changes needed to enable nonexcepted off-campus PBDs to bill for
nonexcepted items and services under the PFS directly (82 FR 53029). As
we continue to explore alternative options related to requirements
under section 1833(t)(21)(C) of the Act, we believed that this overall
approach is still appropriate, and we are finalizing our proposal to
continue to allow nonexcepted off-campus PBDs to bill for nonexcepted
items and services on an institutional claim using a ``PN'' modifier
until we identify a workable alternative mechanism to improve payment
accuracy.
We made several adjustments to our methodology for calculating the
PFS Relativity Adjuster for CY 2019. Most importantly, we had access to
a full year of claims data from CY 2017 for services submitted with the
``PN'' modifier. Incorporating these data allows us to improve the
accuracy of the PFS Relativity Adjuster by accounting for the specific
mix of nonexcepted items and services furnished in nonexcepted off-
campus PBDs. In analyzing the CY 2017 claims data, we identified just
under 2,000 unique OPPS HCPCS/OPPS status indicator (SI) code pairs
reported in CY 2017 with status indicators ``J1'', ``J2'', ``Q1'',
``Q2'', ``Q3'', ``S'', ``T'', or ``V''. The data reinforce our previous
observation that the single most frequently reported service furnished
in nonexcepted off-campus PBDs is HCPCS code G0463. Approximately half
of all claim lines for separately payable or conditionally packaged
services furnished by nonexcepted off-campus PBDs included HCPCS code
G0463 in CY 2017, representing over 30 percent of total Medicare
payments for separately payable or conditionally packaged services. The
top 30 HCPCS/SI code combinations accounted for over 80 percent of all
claim lines and approximately 70 percent of Medicare payments for
services that are separately billable or conditionally packaged. In
contrast with prior analyses, we also looked at claims units, which
reflect HCPCS/SI code combinations that are billed more than once on a
claim line. Certain HCPCS codes are much more frequently billed in
multiple units than others. The largest differences between the number
of claim lines and the number of claims units are for injections and
immunizations, which are not typically separately payable or
conditionally packaged under the OPPS. For instance, HCPCS code Q9967
(Low osmolar contrast material, 300-399 mg/ml iodine concentration, per
ml) was reported in 12,268 claim lines, but 1,168,393 times (claims
units) in the aggregate. HCPCS code Q9967 has an OPPS status indicator
of ``N'', meaning that there is no separate payment under OPPS (items
and services are packaged into APC rates). To calculate the PFS
Relativity Adjuster using the full range of claims data submitted with
a ``PN'' modifier in CY 2017, we first established site-specific rates
under the PFS that reflect the TC of items and services furnished by
nonexcepted off-campus PBDs in CY 2017. These HCPCS-level rates reflect
our best current estimate of the amount that would have been paid for
the service in the office setting under the PFS for practice expenses
(PEs) not associated with the professional component (PC) of the
service. As discussed in prior rulemaking (81 FR 79720 through 79729),
we believe the most appropriate code-level comparison would reflect the
TC of each HCPCS code under the PFS. However, we do not currently
calculate a separate TC rate for all HCPCS codes under the PFS--only
for those for which the PC and TC of the service are distinct and can
be separately billed by two different practitioners or other suppliers
under the PFS. For most of the remainder of services that do not have a
separately payable TC under the PFS, we estimated the site-specific
rate as (1) the difference between the PFS nonfacility rate and the PFS
facility rate, or (2) in instances where payment would have been made
only to the facility or only to the physician, the full nonfacility
rate. As with the PFS rates that we developed when calculating the PFS
Relativity Adjuster for CY 2017 and CY 2018, there were large code-
level differences between the applicable PFS rate and the OPPS rate.
In calculating the proposed PFS Relativity Adjuster for CY 2019, we
employed the same fundamental methodology that we used to calculate the
PFS Relativity Adjuster for CY 2017 and CY 2018. We began by limiting
our analysis to the items and services billed in CY 2017 with a ``PN''
modifier that are separately payable or conditionally packaged under
the OPPS (status indicator = ``J1'', ``J2'', ``Q1'', ``Q2'', ``Q3'',
``S'', ``T'', or ``V'') and compared the rates for these codes under
the OPPS with the site-specific rates under the PFS. Next, we imputed
PFS rates for a limited number of items and services that are
separately payable or conditionally packaged under the OPPS but are
contractor priced under the PFS. We also imputed PFS rates for some
HCPCS codes that are not separately payable under the OPPS (SI =
``N''), but are separately payable under the PFS. This includes items
and services with an indicator status of ``X'' under the PFS, which are
statutorily excluded from payment under the PFS, but may be paid under
a different fee schedule, such as the Clinical Lab Fee Schedule (CLFS).
We summed the HCPCS-level

[[Page 59508]]

rates under the PFS across all nonexcepted items and services, weighted
by the number of HCPCS code claims units for each service. Next, we
calculated the sum of the HCPCS-level OPPS rate for items and services
that are separately payable or conditionally packaged, also weighted by
the number of HCPCS code claims units. We compared the weighted sum of
the site-specific PFS rate with the weighted sum of the OPPS rate for
items and services reported in CY 2017 and we found that our updated
analysis supports maintaining a PFS Relativity Adjuster of 40 percent.
In view of this analysis, we proposed to continue applying a PFS
Relativity Adjuster of 40 percent for CY 2019. Moreover, we proposed to
maintain this PFS Relativity Adjuster for future years until updated
data or other considerations indicate that an alternative adjuster or a
change to our approach is warranted, which we will then propose through
notice and comment rulemaking. We discuss some of our ongoing data
analyses and future plans regarding implementation of section 603 of
the Bipartisan Budget Act of 2015 in this section.
Comment: Several commenters were disappointed that CMS did not
provide the same level of detail regarding the data and methodology
used in calculating the PFS Relativity Adjuster for CY 2019 as we had
in prior rulemaking (CY 2017 and CY 2018). In particular, these
commenters noted that we had previously included specific HCPCS codes
that comprised the top 25 reported, the number of claims lines for each
HCPCS code, and the associated PFS payment rates we used to estimate
the appropriate adjuster. Some commenters maintained that the lack of
specific HCPCS codes and associated PFS payment rates prevented them
from replicating our analysis and commenting on the merits of
maintaining the 40 percent PFS Relativity Adjuster.
Response: We understand and appreciate commenters' interest in
replicating our analysis using the full set of claims data and PFS
payment rates we used to conduct our analysis. However, we do not agree
that commenters were not able to conduct their own analysis for
purposes of evaluating our proposal. The principal data sources in the
analysis are the OPPS CY 2017 rates, the CY 2017 PFS rates, and
institutional claims data for items and services furnished in CY 2017
that included the ``PN'' modifier, which are publicly available
resources. We did not receive specific inquiries indicating that
commenters tried to reproduce our results using these data sources (or
other data sources), nor did we receive any specific alternatives for
consideration. As we noted in the proposed rule, the methodological
aspects of our proposed PFS Relativity Adjuster calculation for CY 2019
differ from the calculation for CY 2017 and CY 2018 by the following
two adjustments: (1) Development of site specific technical-equivalent
rates under the PFS for all HCPCS codes reported on a claim with the
``PN'' modifier in CY 2017; and (2) the addition of OPPS SI ``N''
claims data to the PFS component of the PFS Relativity Adjuster
equation to reflect items and services that are packaged under OPPS but
paid separately under the PFS. We imputed certain PFS rates, such as
for codes that are contractor priced under the PFS, because those would
be paid at the contractor price if the claim had been submitted in a
freestanding office. We remind commenters that adding PFS rates to the
analysis, where such rates would not have otherwise been included, has
the effect of increasing the PFS Relativity Adjuster since the
aggregate PFS payment amount increases relative to the aggregate OPPS
payment amount. Nonetheless, we appreciate the commenters' interest in
validating the results of our analysis. For the convenience of
commenters wishing to conduct analysis of differences in payment rates
between off-campus PBDs and freestanding offices for similar services,
we are providing a public use file (PUF), available on the CMS website
under the ``downloads'' section for this final rule containing the CY
2017 PFS technical-equivalent payment rates for all HCPCS codes
reported on an institutional claim with the ``PN'' modifier, as well as
the OPPS payment rate and the number of claims units by OPPS SI (see
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/
PhysicianFeeSched).
Comment: Commenters posed specific questions about our PFS
Relativity Adjuster calculations and requested that CMS provide
additional detail about the calendar year we used for OPPS and PFS
rates, the specific HCPCS codes for which we imputed PFS rates, our
rationale for weighting the data using claims units instead of claims
lines, and if our analysis accounted for the more extensive packaging
that occurs under the OPPS compared with the PFS.
Response: Although we addressed much, if not all, of the
information requested by these commenters in the discussion of our
methodology in the proposed rule, we provide the following summary,
along with additional detail on specific aspects of our analysis to
respond explicitly to commenters' questions. We began our analysis to
identify the proposed CY 2019 PFS Relativity Adjuster by examining a
full year of claims data for services furnished in CY 2017 that were
reported on an institutional claim form and appended with the ``PN''
modifier. Because claims processed through the institutional setting
are adjudicated based on the OPPS SI, our unit of analysis was the
number of claims units at the HCPCS/SI code level. We used claim units
instead of claim lines because this metric accounts for instances when
a HCPCS code is reported multiple times on the same claim line. We made
this methodological change in formulating our proposal for CY 2019 in
large part to address commenters' concerns from prior years that our
calculations may underrepresent PFS payment for HCPCS codes that would
have been paid multiple times under the PFS if they were reported
separately. For the majority of HCPCS/SI code combinations that were
reported with the ``PN'' modifier, there is little difference between
the number of claim lines and claim units. However, because more units
are separately paid under the PFS than under the OPPS, using claims
units rather than claims lines yielded a slightly higher PFS Relativity
Adjuster.
For CY 2019, our proposed PFS Relativity Adjuster was based on all
HCPCS codes that were submitted on an institutional claim form in CY
2017, appended with the ``PN'' modifier in order to improve the
accuracy of the overall payment comparison using the best data
available regarding the actual mix of services furnished in nonexcepted
off-campus PBDs. In contrast, for CYs 2017 and 2018, we used only a
subset of claims from CY 2016 because of known limitations regarding
the data available at the time. In particular, the data from CY 2016
were based on claims that were appended with the ``PO'' modifier, which
was a new reporting requirement for CY 2016. Although the ``PO''
modifier allowed us to distinguish items and services furnished in off-
campus PBDs in CY 2016, it did not allow us to distinguish between
excepted and nonexcepted off-campus PBDs. The ``PN'' modifier, which
was a new reporting requirement for CY 2017, allows us to make the
distinction between excepted and nonexcepted off-campus PBDs.
In updating our analysis for calculating the proposed PFS
Relativity Adjuster for CY 2019 to include all HCPCS codes that were
reported on an institutional claim with the ``PN'' modifier, we also
extended to all HCPCS

[[Page 59509]]

codes our earlier logic with regard to calculating the site specific
rates that represent the technical-equivalent of the resource costs of
furnishing a service under the PFS. This amount, as we discussed in the
proposed rule, generally reflected: (1) The difference between the PFS
nonfacility payment rate and the PFS facility rate; (2) the TC; or (3)
in instances where payment would have been made only to the facility or
only to the physician, the full nonfacility rate. Applying the same
logic to the fuller range of HCPCS codes, we developed site specific
rates for all HCPCS codes that are nationally priced under the PFS and
we referred to them as the technical-equivalent rates.
To continue with our analysis, we combined the CY 2017 OPPS rates
at the HCPCS code level with the CY 2017 claims data representing
nonexcepted items and services furnished in nonexcepted off-campus
PBDs. Next, we added the technical-equivalent PFS rates for each HCPCS
code, calculated using the approach described above. For both the OPPS
and the PFS portions of the PFS Relativity Adjuster calculations, we
weighted our analysis of HCPCS/SI code combinations by the number of
claims units. For the OPPS component of the calculation, we restricted
our analysis to HCPCS/SI code combinations that had OPPS SI indicators
``J1'', ``J2'', ``Q1'', ``Q2'', ``Q3'', ``S'', ``T'', or ``V'', which
are separately payable or conditionally packaged codes under the OPPS.
We multiplied the number of claims units for each HCPCS/SI code
combination by the OPPS rate for each HCPCS/SI code combination and
summed across the weighted rates. To calculate the PFS component of the
PFS Relativity Adjuster, we used the same OPPS/SI code combinations,
but we also included claims for HCPCS codes with OPPS SI ``N'', which
indicates that, under the OPPS, payment for these services is packaged
into payment for other services. We multiplied the number of claims
units for each HCPCS/SI code combination by the technical-equivalent
PFS rate for each HCPCS code and summed across the HCPCS/SI code
combinations. We believe that adding weighted rates for HCPCS codes
with OPPS SI ``N'' to the PFS allows us to better adjust, although
imprecisely, for the packaging under the OPPS of nonexcepted items and
services for which separate payment would typically be made under the
PFS in the office setting. Although we did not conduct code-level
analysis to estimate packaging under the OPPS, we believe that the
combination of using the full range of claims data for nonexcepted
items and services furnished in nonexcepted off-campus PBDs, using
claim units rather than claim lines to weight rates on both the OPPS
and PFS, and adding PFS rates for HCPCS codes with OPPS status
indicator ``N'' is an improved approach to the PFS Relativity Adjuster
that better accounts for OPPS packaging policies.
To increase the precision of our analysis, we imputed payment rates
under the PFS for certain HCPCS codes for which payment is based on
rates other than national PFS pricing. For services that are
contractor-priced under the PFS, as indicated by a PFS status indicator
of ``C'', we applied the national median allowed charge for these
services in CY 2017. For a limited number of other services, where
appropriate, we incorporated rates from the applicable fee schedule
under which the service may have been paid if furnished in a
freestanding office. For instance, HCPCS codes with a PFS status
indicator of either ``X'' (service is statutorily excluded for payment
under PFS) or ``E'' (service is excluded from payment under PFS by
regulation), may be paid under the CLFS or the National Limitation
Amount (NLA). The imputed values that we used, both from contractor
priced codes and other fee schedules, are included in the data file
that will be posted with this final rule, available at https://
www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/
PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
Although there remains a certain level of imprecision inherent in
our analysis, we believe the margin of error is relatively small and
would likely affect the PFS and OPPS amounts similarly. For instance,
we did not take into account the several MPPRs that would reduce
payment on the PFS side when multiple codes are billed together. In
many cases, these codes are packaged under the OPPS, so not including
the PFS MPPRs in our analysis has the effect of increasing the PFS
component of the calculation by a marginal amount. Likewise, we
recognize that because of existing packaging rules under the OPPS,
there is likely to be underreporting of codes on institutional claims
for which the hospital does not receive separate payment, but for which
the practitioner might receive separate payment if furnished in a
freestanding office and reported on a professional claim form. This
would effectively reduce the PFS Relativity Adjuster, but only to the
extent hospitals are not appropriately reporting furnished items and
services.
Comment: Many commenters expressed that the appropriate point of
comparison for PFS technical-equivalent rates is the full nonfacility
rate rather than the difference between the nonfacility rate and the
facility rate. The commenters stated that since hospitals, like
freestanding offices, incur both direct and indirect costs when
services are furnished in nonexcepted off-campus PBDs, the difference
between the nonfacility rate and the facility rate does not
appropriately account for indirect costs incurred by the facility.
Response: We believe the commenters misunderstood the methodology
for allocating direct and indirect costs as part of the PFS ratesetting
process. Under the PFS algorithm for allocating indirect costs,
nonfacility PFS rates include indirect PE that is directly related to
the resources associated with the professional portion of the service
alone. In other words, this is the indirect PE that is also paid by
Medicare to professionals like physicians when they report services in
the hospital setting. In addition to these indirect PE RVUs,
nonfacility PFS rates include indirect PE RVUs allocated based on the
direct PE inputs. We believe these indirect costs, those associated
with provision of the technical aspects of the service alone, are
analogous to those incurred by facilities when professionals furnish
services there. To be clear, even when the total nonfacility rates are
reduced by the facility rates, there are remaining PE RVUs that result
from both direct inputs and indirect allocations under the established
PFS methodology. We agree with the commenters that nonexcepted off-
campus PBDs incur indirect costs, but we believe our calculation for
the technical-equivalent PFS rates includes the relative resource costs
of indirect expenses involved in furnishing the services. We also note
that CMS makes corresponding payments under the PFS at the facility
rate for nonexcepted items and services furnished in nonexcepted off-
campus PBD settings, meaning that CMS is already paying for some of the
indirect expenses associated with the PCs of the service. If CMS were
to use the full nonfacility PE RVUs as the basis for comparing PFS
rates to OPPS rates, we would effectively be paying twice for a portion
of indirect costs, once under the PFS for the PC of services and again
through the PFS Relativity Adjusted payment under the OPPS to off-
campus PBDs for the facility part of the same service.
We recognize that the process of allocating indirect costs under
the PFS is built on assumptions about

[[Page 59510]]

organizational practices and healthcare payment structures that may not
fully reflect the current health care delivery environment, especially
where physicians and other professionals are paid under salaried
arrangements by institutions such as hospitals. Under the current PFS
payment methodology, we assume that indirect costs associated with
professional services furnished in institutions like hospital PBDs are
incurred by the individual practitioners and not by the institutions.
We may consider this issue for future rulemaking.
Comment: A commenter requested that CMS clarify how, in calculating
the PFS Relativity Adjuster, CMS treated codes that are valued under
the PFS only in a facility setting. Because these HCPCS codes do not
have PE inputs reflecting the specific costs of furnishing a service in
a freestanding office, the commenter stated concern that these codes
may have been incorrectly incorporated in the analysis at a PFS payment
rate of zero.
Response: We appreciate the commenter's concern and the opportunity
to clarify the way we treated services not priced in the nonfacility
setting in calculating the PFS Relativity Adjuster. Because there are
no PFS payment rates for these services in the nonfacility setting, we
incorporated the OPPS rate as the technical equivalent rate under the
PFS.
Comment: Several commenters were opposed to our proposal to
maintain the PFS Relativity Adjuster at 40 percent, citing both the
lack of transparency in our methodology and prior analyses provided by
the American Hospital Association (AHA) in earlier notice and comment
rulemaking, suggesting that a 65 percent PFS Relativity Adjuster would
appropriately incorporate into the Adjuster the additional packaging
that occurs under the OPPS. Two commenters urged CMS to implement a 75
percent PFS Relativity Adjuster for CY 2019, although no specific
rationale was given.
Response: We accounted for packaging under the OPPS by including
PFS payment rates for HCPCS codes that were reported with OPPS SI
``N''. Our analysis does not support a PFS Relativity Adjuster of 65 or
75 percent, but rather indicates that a PFS Relativity Adjuster of 40
percent appropriately accounts for packaging of services under the
OPPS. For additional discussion of the challenges related to
incorporating the effect of packaging into the PFS Relativity Adjuster,
we refer readers to the CY 2018 PFS final rule (82 FR 53024 through
53022).
Comment: A commenter stated that CMS has not provided sufficient
justification for continuation of a reduction in payment of 60 percent
for nonexcepted items and services furnished in nonexcepted off campus
PBDs. Commenters noted that the first 2017 claims from the initial
period of implementation of this policy are only now being incorporated
into CMS claims files. The commenter indicated that there is an
insufficient volume of claims to determine the impact this policy is
having on beneficiary access to services in the PBD setting,
particularly at the 40 percent Relativity Adjuster. The commenter
stated that CMS should, at minimum, restore the 50 percent PFS
Relativity Adjuster that was in place for CY 2017.
Response: We appreciate the commenter's suggestions, but we do not
agree that there is insufficient data to support the PFS Relativity
Adjuster of 40 percent. We have no reason to believe that the CY 2017
claims data are not as robust as any other claims based analysis and,
to the extent that we recognize, acknowledge, and try to account for
difference in payment policies between the PFS and OPPS, we believe our
analysis demonstrates that a PFS Relativity Adjuster of 40 percent is
appropriate.
Comment: Several commenters supported the 40 percent PFS Relativity
Adjuster for CY 2019 and future years because this will provide
stability for clinicians practicing in these settings and not disrupt
patient access to care. One commenter cited the importance of making
gradual changes to site neutrality policies to ensure alignment with
other rapid changes in Medicare and the private sector regarding
provider payment, including the movement to value-based purchasing and
alternative payment systems.
Response: We agree with the commenter that there is value in the
stability of maintaining the PFS Relativity Adjuster at 40 percent,
particularly to the extent that this enables continuity of care for
beneficiaries. We appreciate the support from commenters.
Comment: Some commenters, rather than opposing any particular PFS
Relativity Adjuster, expressed disappointment that CMS did not propose
to make broader changes to implement site-neutrality under section 603
of the Bipartisan Budget Act of 2015. Commenters were displeased that
CMS is continuing to implement the requirements of the legislation
using a single scaling factor applied to payment rates under the OPPS.
Instead, they stated CMS should revise the applicable payment rates to
appropriately reimburse for services provided by off-campus PBDs.
Commenters did not provide specific suggestions for implementing
alternative policies, but several commenters noted that a single
overall scaling factor was intended by CMS to be an interim, not a long
term policy solution. A few commenters suggested that the PFS
Relativity Adjuster as a mechanism for implementing section 603 of the
Bipartisan Budget Act of 2015 is not consistent with the requirement
under that section to pay for nonexcepted items and services under the
applicable payment system because this approach is still fundamentally
based on OPPS payment rates. Other commenters stated that nonexcepted
off-campus PBDs differ from one another in the mix of services
furnished and the beneficiary population and that CMS payment policies
should reflect those variances.
Despite concerns about the appropriateness of the PFS Relativity
Adjuster for implementing requirements under section 603 of the
Bipartisan Budget Act of 2015, several of the same commenters pointed
out that there are significant advantages of continuing to allow
hospitals to bill for items and services furnished in nonexcepted PBDs
using the institutional claim form. In particular, they stated, this
allows PBDs to properly use cost reporting procedures and to accurately
reconcile the cost report to hospital ledgers for all services and
departments and to correctly allow revenue for nonexcepted PBDs to flow
through the Provider Statistical and Reimbursement (PS&R) report.
Response: We previously expressed interest in exploring how
hospitals might report and receive payment for nonexcepted items and
services furnished in nonexcepted off-campus PBDs using the standard
PFS payment rates based on HCPCS-specific RVUs. However, CMS does not
currently develop as part of the PFS ratesetting process separate
payment rates for the technical aspects of the full range of
nonexcepted items and services furnished in nonexcepted off-campus PBDs
specifically for services for which there are not separately valued PCs
and TCs. As such, we do not have a consistent way for nonexcepted off-
campus PBDs and the professionals who furnish services in those
settings to bill for the respective portions of the services for which
they incurred costs. Additionally, while the statute was amended to
change the nature and payment of nonexcepted items and services
furnished in nonexcepted off-campus PBDs, the amendments did not

[[Page 59511]]

alter the status of non-excepted off-campus PBDs as parts of hospitals.
Nonexcepted off-campus PBDs are still required to follow all reporting
and regulatory policies consistent with hospital settings.
We continue to explore options that would allow hospitals to report
nonexcepted items and services on an institutional claim form but
receive payments that more directly reflect the technical aspect of
services under the PFS. In general, we believe there may be additional
utility, especially in the context of improving price transparency for
Medicare beneficiaries, in establishing and displaying a set of payment
rates, recalculated annually as part of the annual PFS rulemaking
cycle, that reflect the relative resource costs of the technical
aspects of furnishing PFS services.
Along with this final rule, we are including the technical-
equivalent rates that we developed specifically for calculating the PFS
Relativity Adjuster for CY 2019, which is the current mechanism for
implementing the PFS as the applicable payment system for nonexcepted
items and services furnished in nonexcepted off-campus PBDs. This
information is being made available under the downloads section for
this final rule on the CMS website at https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-
Regulation-Notices.html.
Comment: Several commenters supported our ongoing efforts to
implement site neutral payments in the context of section 603 of the
Bipartisan Budget Act of 2015. Several commenters indicated their
support for additional policies that would equalize payment across
freestanding offices and hospital PBDs, both on-campus and off-campus.
Response: We recognize that this is a topic of great interest to
many commenters and we welcome the range of perspectives and ideas
posed by commenters.
Comment: Some commenters disagreed with our view that the
amendments under section 603 of the Bipartisan Budget Act of 2015 were
intended to produce site neutral payments between freestanding offices
and off-campus PBDs with the goal of removing incentives for hospitals
to purchase physician offices. These commenters noted that hospital
PBDs face higher costs than freestanding offices, such as those
associated with regulatory requirements, and reducing payment to
nonexcepted off-campus PBDs threatens the viability of hospitals that
serve a vital role in providing services to rural and underserved
communities in these off-campus settings. We received several comment
letters from Medicare beneficiaries expressing concern about reduced
payments to their community's major medical hospital offsite locations.
The commenters stated that without the hospital's offsite locations
community members would be forced to drive unreasonable distances to
seek basic and immediate care.
Response: We understand the commenters' concerns, especially with
regard to maintaining access to appropriate care. CMS continues to
evaluate data regarding beneficiary access to care to identify possible
issues. We also agree that hospitals face additional regulatory and
operational costs not generally incurred by physician offices, and that
OPDs of a hospital function as an important and integral part of the
Medicare care delivery infrastructure. However, many off-campus PBDs
are similar to physician's offices and do not necessarily have the same
operational costs as the main hospital. We believe that the amendments
made to the statute by section 603 of the Bipartisan Budget Act of 2015
were intended to reduce Medicare payment incentives for hospitals to
purchase physician offices, convert them to off-campus PBDs, and bill
under the OPPS for items and services furnished there.
Comment: Several commenters opposed our inclusion of the proposal
related to payment for nonexcepted off-campus PBDs under the CY 2019
PFS rule instead of the CY 2019 OPPS/ASC rule. They suggested that
proposals related to the payment rate for nonexcepted items and
services furnished in nonexcepted off-campus PBDs are inseparable from
proposals and comment solicitations in the OPPS/ASC rule related to
service line expansions and other payment policies related to
implementation of the amendments under section 603 of the Bipartisan
Budget Act of 2015. Some commenters suggested that, for purposes of
administrative simplification, the discussion of any changes to site-
of-service payments regarding PBDs of a hospital should be fully
maintained within a single rule and recommended this be included in the
OPPS rule. Some commenters expressed concern that the PFS and OPPS
proposed rules were not released at the same time and that this
presents challenges for them in reconciling and preparing their
comments on each rule.
Response: We appreciate commenters' concerns about responding to
two separate rules for policies associated with payment for nonexcepted
items and services furnished in nonexcepted off-campus PBDs. However,
we note that in finalizing the PFS as the applicable payment system for
most nonexcepted items and services, proposals related to the
implementation of payment rates under the PFS fall reasonably under the
purview of PFS rulemaking, while proposals related to the applicability
of those rates are more appropriately addressed in OPPS/ASC rulemaking.
We will consider these concerns for future rulemaking.
We believe that our proposal to maintain the PFS Relativity
Adjuster at 40 percent for CY 2019 and for future years reflects an
analysis that accounts for many of the concerns expressed by commenters
regarding the PFS Relativity Adjuster in prior rules. Therefore, we are
finalizing the proposal to maintain the PFS Relativity Adjuster at 40
percent for CY 2019 and beyond until there is an appropriate reason and
process for implementing an alternative to our current policy, at which
time we will make a proposal through notice and comment rulemaking.
5. Policies Related to Supervision, Beneficiary Cost-Sharing, and
Geographic Adjustments
In the CY 2018 PFS final rule (81FR 53019 through 53031), we
finalized policies related to supervision rules, beneficiary cost
sharing, and geographic adjustments. We finalized that supervision
rules in nonexcepted off-campus PBDs that furnish nonexcepted items and
services are the same as those that apply for hospitals, in general. We
also finalized that all beneficiary cost sharing rules that apply under
the PFS in accordance with sections 1848(g) and 1866(a)(2)(A) of the
Act continue to apply when payment is made under the PFS for
nonexcepted items and services furnished by nonexcepted off-campus
PBDs, regardless of cost sharing obligations under the OPPS. Lastly, we
finalized the policy to apply the same geographic adjustments used
under the OPPS to nonexcepted items and services furnished in
nonexcepted off-campus PBDs. We are maintaining these policies for CY
2019, as finalized in the CY 2018 PFS final rule.
6. Partial Hospitalization
a. Partial Hospitalization Services
Partial hospitalization programs (PHPs) are intensive outpatient
psychiatric day treatment programs furnished to patients as an
alternative to inpatient psychiatric hospitalization, or as a stepdown
to shorten an inpatient stay and transition a patient to a less
intensive level of care. Section

[[Page 59512]]

1861(ff)(3)(A) of the Act specifies that a PHP is a program furnished
by a hospital, to its outpatients, or by a community mental health
center (CMHC). In the CY 2017 OPPS/ASC proposed rule (81 FR 45690), in
the discussion of the proposed implementation of section 603 of
Bipartisan Budget Act of 2015, we noted that because CMHCs also furnish
PHP services and are ineligible to be provider-based to a hospital, a
nonexcepted off-campus PBD would be eligible for PHP payment if the
entity enrolls and bills as a CMHC for payment under the OPPS. We
further noted that a hospital may choose to enroll a nonexcepted off-
campus PBD as a CMHC, provided it meets all Medicare requirements and
conditions of participation.
In response to that rule, commenters expressed concern that without
a clear payment mechanism for PHP services furnished by nonexcepted
off-campus PBDs, access to partial hospitalization services would be
limited, and pointed out the critical role PHPs play in the continuum
of mental health care. Many commenters noted that the Congress did not
intend for partial hospitalization services to no longer be paid for by
Medicare when such services are furnished by nonexcepted off-campus
PBDs. Several commenters disagreed with the notion of enrolling as a
CMHC in order to receive payment for PHP services. The commenters
stated that hospital-based PHPs and CMHCs are inherently different in
structure, operation, and payment, and noted that the conditions of
participation for hospital departments and CMHCs are different. Several
commenters requested that CMS find a mechanism to pay hospital-based
PHPs in nonexcepted off-campus PBDs.
We agreed with the commenters' concerns and adopted payment for
partial hospitalization items and services furnished by nonexcepted
off-campus PBDs under the PFS in the CY 2017 OPPS/ASC final rule with
comment period and interim final rule with comment period (81 FR 79715,
79717, and 79727). When billed in accordance with the CY 2017 PFS final
rule, these partial hospitalization services are paid at the CMHC per
diem rate for APC 5853, for providing three or more partial
hospitalization services per day (81 FR 79727).
In the CY 2017 OPPS/ASC proposed rule (81 FR 45681), and the CY
2017 OPPS/ASC final rule with comment period/interim final rule with
comment period (81 FR 79717 and 79727), we noted that when a
beneficiary receives outpatient services in an off-campus department of
a hospital, the total Medicare payment for those services is generally
higher than when those same services are provided in a physician's
office. Similarly, when partial hospitalization services are provided
in a hospital-based PHP, Medicare pays more than when those same
services are provided by a CMHC. Our rationale for adopting the CMHC
per diem rate for APC 5853 as the PFS payment amount for nonexcepted
off-campus PBDs providing PHP services is because CMHCs are
freestanding entities that are not part of a hospital, but they provide
the same PHP services as hospital-based PHPs (81 FR 79727). This is
similar to the differences between freestanding entities paid under the
PFS that furnish other services also provided by hospital-based
entities. Similar to other entities currently paid for their TC
services under the PFS, we believe CMHCs would typically have lower
cost structures than hospital-based PHPs, largely due to lower overhead
costs and other indirect costs such as administration, personnel, and
security. We believe that paying for nonexcepted hospital-based partial
hospitalization services at the lower CMHC per diem rate aligns with
section 603 of Bipartisan Budget Act of 2015, while also preserving
access to PHP services. In addition, nonexcepted off-campus PBDs will
not be required to enroll as CMHCs in order to bill and be paid for
providing partial hospitalization services. However, a nonexcepted off-
campus PBD that wishes to provide PHP services may still enroll as a
CMHC if it chooses to do so and meets the relevant requirements.
Finally, we recognize that because hospital-based PHPs are providing
partial hospitalization services in the hospital outpatient setting,
they can offer benefits that CMHCs do not have, such as an easier
patient transition to and from inpatient care, and easier sharing of
health information between the PHP and the inpatient staff.
In the CY 2018 PFS final rule, we did not require these PHPs to
enroll as CMHCs but instead we continued to pay nonexcepted off-campus
PBDs providing PHP items and services under the PFS. Further, in that
CY 2018 PFS final rule (82 FR 53025 to 53026), we continued to adopt
the CMHC per diem rate for APC 5853 as the PFS payment amount for
nonexcepted off-campus PBDs providing three or more PHP services per
day in CY 2018.
For CY 2019, we proposed to continue to identify the PFS as the
applicable payment system for PHP services furnished by nonexcepted
off-campus PBDs, and proposed to continue to set the PFS payment rate
for these PHP services as the per diem rate that will be paid to a CMHC
in CY 2019. We further proposed to maintain these policies for future
years until updated data or other considerations indicate that a change
to our approach is warranted, which we will then propose through notice
and comment rulemaking.
We received no comments on our PHP proposals for CY 2019 and future
years, and are finalizing our policies as proposed.
7. Future Years
We continue to believe the amendments made by section 603 of the
Bipartisan Budget Act of 2015 were intended to reduce the Medicare
payment incentive for hospitals to purchase physician offices, convert
them to off-campus PBDs, and bill under the OPPS for items and services
they furnish there. Therefore, we continue to believe the payment
policy under this provision should ultimately equalize payment rates
between nonexcepted off-campus PBDs and physician offices to the
greatest extent possible, while allowing nonexcepted off-campus PBDs to
bill in a straight-forward way for services they furnish.
In developing our proposal for CY 2019 as described previously, we
incorporated all HCPCS codes that appeared in CY 2017 claims data from
nonexcepted off-campus PBDs. We also expanded the number of site
specific, technical-equivalent rates for nonexcepted items and services
furnished in nonexcepted off-campus PBDs, in order to ensure that
Medicare payment to hospitals billing for nonexcepted items and
services furnished by nonexcepted off-campus PBDs reflects the relative
resources involved in furnishing the items and services. We recognize
that for certain specialties, service lines, and nonexcepted off-campus
PBDs, total Medicare payments for the same services might be either
higher or lower when furnished by a nonexcepted off-campus PBD rather
than in a physician office.
We intend to continue to examine the claims data in order to assess
whether a different PFS Relativity Adjuster is warranted and also to
consider whether additional adjustments to the methodology are
appropriate. In particular, we are monitoring claims for shifts in the
mix of services furnished in nonexcepted off-campus PBDs that may
affect the relativity between the PFS and OPPS. An increase over time
in the share of nonexcepted items and services with lower technical-
equivalent rates under the PFS compared with APC rates

[[Page 59513]]

under the OPPS might result in a lower PFS Relativity Adjuster, for
example. We will also carefully assess annual payment policy updates to
the PFS and OPPS, respectively, to identify changes in overall
relativity resulting from any new or modified policies, such as
expanded packaging under the OPPS or an increase in the number of HCPCS
codes with global periods under the PFS. As part of these ongoing
efforts, we are also analyzing PFS claims data to identify patterns of
services furnished together on the same day. We anticipate that this
will ultimately allow us to make refinements to the PFS Relativity
Adjuster to better account for the more extensive packaging of services
under the OPPS and the potential underreporting of services that are
not separately payable under the OPPS but are paid separately under the
PFS.
Another dimension of our ongoing efforts to improve implementation
of section 603 of the Bipartisan Budget Act of 2015 is the development
and refinement of a new set of payment rates under the PFS that reflect
the relative resource costs of furnishing the TC of items and services
furnished in nonexcepted off-campus PBDs. Although we believe that our
site-specific HCPCS code-level rates reflect the best available
estimate of the amount that would have been paid for the service in the
office setting under the PFS for practice expenses not associated with
the PC of the service, for the majority of HCPCS codes there is no
established methodology for separately valuing the resource costs
incurred by a provider while furnishing a service from those incurred
exclusively by the facility in which the service is furnished. We
continue to explore alternatives to our current estimates that would
better reflect the TC of services furnished in nonexcepted off-campus
PBDs. We are broadly interested in stakeholder feedback and
recommendations for ways in which CMS can improve pricing and
transparency with regard to the differences in the payment rates across
sites of service.
We expect that our continued analyses of claims data and our
ongoing exploration of systems changes that are needed to allow
nonexcepted off-campus PBDs to bill directly for the TC portion of
nonexcepted items and services may lead us to consider a different
approach for implementing section 603 of the Bipartisan Budget Act of
2015. On the whole, however, we believe that a PFS Relativity Adjuster
for CY 2019 of 40 percent advances efforts to equalize payment rates in
the aggregate between physician offices and nonexcepted off-campus
PBDs. Maintaining our policy of applying an overall scaling factor to
OPPS payments allows hospitals to continue billing through a facility
claim form and permits continued use of the packaging rules and cost
report-based relative payment rate determinations for nonexcepted
services.

H. Valuation of Specific Codes

1. Background: Process for Valuing New, Revised, and Potentially
Misvalued Codes
Establishing valuations for newly created and revised CPT codes is
a routine part of maintaining the PFS. Since the inception of the PFS,
it has also been a priority to revalue services regularly to make sure
that the payment rates reflect the changing trends in the practice of
medicine and current prices for inputs used in the PE calculations.
Initially, this was accomplished primarily through the 5-year review
process, which resulted in revised work RVUs for CY 1997, CY 2002, CY
2007, and CY 2012, and revised PE RVUs in CY 2001, CY 2006, and CY
2011, and revised MP RVUs in CY 2010 and CY 2015. Under the 5-year
review process, revisions in RVUs were proposed and finalized via
rulemaking. In addition to the 5-year reviews, beginning with CY 2009,
CMS and the RUC identified a number of potentially misvalued codes each
year using various identification screens, as discussed in section
II.E. of this final rule, Potentially Misvalued Services under the PFS.
Historically, when we received RUC recommendations, our process had
been to establish interim final RVUs for the potentially misvalued
codes, new codes, and any other codes for which there were coding
changes in the final rule with comment period for a year. Then, during
the 60-day period following the publication of the final rule with
comment period, we accepted public comment about those valuations. For
services furnished during the calendar year following the publication
of interim final rates, we paid for services based upon the interim
final values established in the final rule. In the final rule with
comment period for the subsequent year, we considered and responded to
public comments received on the interim final values, and typically
made any appropriate adjustments and finalized those values.
In the CY 2015 PFS final rule with comment period, we finalized a
new process for establishing values for new, revised and potentially
misvalued codes. Under the new process, we include proposed values for
these services in the proposed rule, rather than establishing them as
interim final in the final rule with comment period. Beginning with the
CY 2017 PFS proposed rule, the new process was applicable to all codes,
except for new codes that describe truly new services. For CY 2017, we
proposed new values in the CY 2017 PFS proposed rule for the vast
majority of new, revised, and potentially misvalued codes for which we
received complete RUC recommendations by February 10, 2016. To complete
the transition to this new process, for codes for which we established
interim final values in the CY 2016 PFS final rule with comment period,
we reviewed the comments received during the 60-day public comment
period following release of the CY 2016 PFS final rule with comment
period, and re-proposed values for those codes in the CY 2017 PFS
proposed rule.
We considered public comments received during the 60-day public
comment period for the proposed rule before establishing final values
in the CY 2017 PFS final rule. As part of our established process, we
will adopt interim final values only in the case of wholly new services
for which there are no predecessor codes or values and for which we do
not receive recommendations in time to propose values. For CY 2017, we
did not identify any new codes that described such wholly new services.
Therefore, we did not establish any code values on an interim final
basis.
For CY 2018, we generally proposed the RUC-recommended work RVUs
for new, revised, and potentially misvalued codes. We proposed these
values based on our understanding that the RUC generally considers the
kinds of concerns we historically raised regarding appropriate
valuation of work RVUs. However, during our review of these recommended
values, we identified some concerns similar to those we recognized in
prior years. Given the relative nature of the PFS and our obligation to
ensure that the RVUs reflect relative resource use, we included
descriptions of potential alternative approaches we might have taken in
developing work RVUs that differed from the RUC-recommended values. We
sought comment on both the RUC-recommended values, as well as the
alternatives considered. Several commenters generally supported the
proposed use of the RUC-recommended work RVUs, without refinement.
Other commenters expressed concern about the effect of the misvalued
code reviews on particular specialties and settings and disappointment
with our proposed

[[Page 59514]]

approach for valuing codes for CY 2018. A detailed summary of the
comments and our responses can be found in the CY 2018 PFS final rule
(82 FR 53033-53035).
We clarified in response to commenters that we are not
relinquishing our obligation to independently establish appropriate
RVUs for services paid under the PFS. We will continue to thoroughly
review and consider information we receive from the RUC, the Health
Care Professionals Advisory Committee (HCPAC), public commenters,
medical literature, Medicare claims data, comparative databases,
comparison with other codes within the PFS, as well as consultation
with other physicians and healthcare professionals within CMS and the
federal government as part of our process for establishing valuations.
Although generally proposing the RUC-recommended work RVUs for new,
revised, and potentially misvalued codes was our approach for CY 2018,
we note that we also included alternative values where we believed
there was a possible opportunity for increased precision. We also
clarified that as part of our obligation to establish RVUs for the PFS,
we annually make an independent assessment of the available
recommendations, supporting documentation, and other available
information from the RUC and other commenters to determine the
appropriate valuations. Where we concur that the RUC's recommendations,
or recommendations from other commenters, are reasonable and
appropriate and are consistent with the time and intensity paradigm of
physician work, we propose those values as recommended. Additionally,
we will continue to engage with stakeholders, including the RUC, with
regard to our approach for accurately valuing codes, and as we
prioritize our obligation to value new, revised, and potentially
misvalued codes. We continue to welcome feedback from all interested
parties regarding valuation of services for consideration through our
rulemaking process.
2. Methodology for Establishing Work RVUs
For each code identified in this section, we conducted a review
that included the current work RVU (if any), RUC-recommended work RVU,
intensity, time to furnish the preservice, intraservice, and
postservice activities, as well as other components of the service that
contribute to the value. Our reviews of recommended work RVUs and time
inputs generally included, but had not been limited to, a review of
information provided by the RUC, the HCPAC, and other public
commenters, medical literature, and comparative databases, as well as a
comparison with other codes within the PFS, consultation with other
physicians and health care professionals within CMS and the federal
government, as well as Medicare claims data. We also assessed the
methodology and data used to develop the recommendations submitted to
us by the RUC and other public commenters and the rationale for the
recommendations. In the CY 2011 PFS final rule with comment period (75
FR 73328 through 73329), we discussed a variety of methodologies and
approaches used to develop work RVUs, including survey data, building
blocks, crosswalks to key reference or similar codes, and magnitude
estimation (see the CY 2011 PFS final rule with comment period (75 FR
73328 through 73329) for more information). When referring to a survey,
unless otherwise noted, we mean the surveys conducted by specialty
societies as part of the formal RUC process.
Components that we used in the building block approach may have
included preservice, intraservice, or postservice time and post-
procedure visits. When referring to a bundled CPT code, the building
block components could include the CPT codes that make up the bundled
code and the inputs associated with those codes. We used the building
block methodology to construct, or deconstruct, the work RVU for a CPT
code based on component pieces of the code. Magnitude estimation refers
to a methodology for valuing work that determines the appropriate work
RVU for a service by gauging the total amount of work for that service
relative to the work for a similar service across the PFS without
explicitly valuing the components of that work. In addition to these
methodologies, we frequently utilized an incremental methodology in
which we value a code based upon its incremental difference between
another code and another family of codes. The statute specifically
defines the work component as the resources in time and intensity
required in furnishing the service. Also, the published literature on
valuing work has recognized the key role of time in overall work. For
particular codes, we refined the work RVUs in direct proportion to the
changes in the best information regarding the time resources involved
in furnishing particular services, either considering the total time or
the intraservice time.
Several years ago, to aid in the development of preservice time
recommendations for new and revised CPT codes, the RUC created
standardized preservice time packages. The packages include preservice
evaluation time, preservice positioning time, and preservice scrub,
dress and wait time. Currently, there are preservice time packages for
services typically furnished in the facility setting (for example,
preservice time packages reflecting the different combinations of
straightforward or difficult procedure, and straightforward or
difficult patient). Currently, there are three preservice time packages
for services typically furnished in the nonfacility setting.
We developed several standard building block methodologies to value
services appropriately when they have common billing patterns. In cases
where a service is typically furnished to a beneficiary on the same day
as an evaluation and management (E/M) service, we believe that there is
overlap between the two services in some of the activities furnished
during the preservice evaluation and postservice time. Our longstanding
adjustments have reflected a broad assumption that at least one-third
of the work time in both the preservice evaluation and postservice
period is duplicative of work furnished during the E/M visit.
Accordingly, in cases where we believe that the RUC has not
adequately accounted for the overlapping activities in the recommended
work RVU and/or times, we adjusted the work RVU and/or times to account
for the overlap. The work RVU for a service is the product of the time
involved in furnishing the service multiplied by the intensity of the
work. Preservice evaluation time and postservice time both have a long-
established intensity of work per unit of time (IWPUT) of 0.0224, which
means that 1 minute of preservice evaluation or postservice time
equates to 0.0224 of a work RVU.
Therefore, in many cases when we removed 2 minutes of preservice
time and 2 minutes of postservice time from a procedure to account for
the overlap with the same day E/M service, we also removed a work RVU
of 0.09 (4 minutes x 0.0224 IWPUT) if we did not believe the overlap in
time had already been accounted for in the work RVU. The RUC has
recognized this valuation policy and, in many cases, now addresses the
overlap in time and work when a service is typically furnished on the
same day as an E/M service.
The following paragraphs contain a general discussion of our
approach to reviewing RUC recommendations and developing proposed
values for specific codes. When they exist we also include a summary of
stakeholder reactions to

[[Page 59515]]

our approach. We note that many commenters and stakeholders have
expressed concerns over the years with our ongoing adjustment of work
RVUs based on changes in the best information we had regarding the time
resources involved in furnishing individual services. We have been
particularly concerned with the RUC's and various specialty societies'
objections to our approach given the significance of their
recommendations to our process for valuing services and since much of
the information we used to make the adjustments is derived from their
survey process. We are obligated under the statute to consider both
time and intensity in establishing work RVUs for PFS services. As
explained in the CY 2016 PFS final rule with comment period (80 FR
70933), we recognize that adjusting work RVUs for changes in time is
not always a straightforward process, so we have applied various
methodologies to identify several potential work values for individual
codes.
We have observed that for many codes reviewed by the RUC,
recommended work RVUs have appeared to be incongruous with recommended
assumptions regarding the resource costs in time. This has been the
case for a significant portion of codes for which we recently
established or proposed work RVUs that are based on refinements to the
RUC-recommended values. When we have adjusted work RVUs to account for
significant changes in time, we have started by looking at the change
in the time in the context of the RUC-recommended work RVU. When the
recommended work RVUs do not appear to account for significant changes
in time, we have employed the different approaches to identify
potential values that reconcile the recommended work RVUs with the
recommended time values. Many of these methodologies, such as survey
data, building block, crosswalks to key reference or similar codes, and
magnitude estimation have long been used in developing work RVUs under
the PFS. In addition to these, we sometimes used the relationship
between the old time values and the new time values for particular
services to identify alternative work RVUs based on changes in time
components.
In so doing, rather than ignoring the RUC-recommended value, we
have used the recommended values as a starting reference and then
applied one of these several methodologies to account for the
reductions in time that we believe were not otherwise reflected in the
RUC-recommended value. If we believed that such changes in time were
already accounted for in the RUC's recommendation, then we did not make
such adjustments. Likewise, we did not arbitrarily apply time ratios to
current work RVUs to calculate proposed work RVUs. We used the ratios
to identify potential work RVUs and considered these work RVUs as
potential options relative to the values developed through other
options.
We do not imply that the decrease in time as reflected in survey
values should always equate to a one-to-one or linear decrease in newly
valued work RVUs. Instead, we have believed that, since the two
components of work are time and intensity, absent an obvious or
explicitly stated rationale for why the relative intensity of a given
procedure has increased, significant decreases in time should be
reflected in decreases to work RVUs. If the RUC's recommendation has
appeared to disregard or dismiss the changes in time, without a
persuasive explanation of why such a change should not be accounted for
in the overall work of the service, then we have generally used one of
the aforementioned methodologies to identify potential work RVUs,
including the methodologies intended to account for the changes in the
resources involved in furnishing the procedure.
Several stakeholders, including the RUC, have expressed general
objections to our use of these methodologies and deemed our actions in
adjusting the recommended work RVUs as inappropriate; other
stakeholders have also expressed general concerns with CMS refinements
to RUC recommended values in general. In the CY 2017 PFS final rule (81
FR 80272 through 80277) we responded in detail to several comments that
we received regarding this issue. In the CY 2017 PFS proposed rule, we
requested comments regarding potential alternatives to making
adjustments that would recognize overall estimates of work in the
context of changes in the resource of time for particular services;
however, we did not receive any specific potential alternatives. As
described earlier in this section, crosswalks to key reference or
similar codes is one of the many methodological approaches we have
employed to identify potential values that reconcile the RUC-recommend
work RVUs with the recommended time values when the RUC-recommended
work RVUs did not appear to account for significant changes in time.
Following the publication of the CY 2019 PFS proposed rule, we
received several comments noting that there was some confusion in the
terminology between ``reference services'' and ``crosswalks.''
Commenters stated that ``reference services'' are services indicated by
the specialty society or the RUC as a good comparator that demonstrates
relativity using magnitude estimation as requiring similar physician
work, time, intensity and complexity. ``Key reference services'' are
the top two services selected by the survey respondents as most similar
to the code being surveyed. By contrast, ``crosswalks'' are services
that have similar or exact intraservice time and require the same
physician work (that is, have the same work RVU), and the term
``crosswalk'' should only be used when making a comparison to a CPT
code with the identical work RVU. The commenters noted that these terms
were used interchangeably in the proposed rule when they have distinct
and separate meanings.
In response to the commenters, we would like to clarify that the
terms ``reference services'', ``key reference services'', and
``crosswalks'' as described by the commenters are part of the RUC's
process for code valuation. These are not terms that we created, and we
do not agree that we necessarily must employ them in the identical
fashion for the purposes of discussing our valuation of individual
services that come up for review. However, in the interest of
minimizing confusion and providing clear language to facilitate
stakeholder feedback, we will seek to limit the use of the term,
``crosswalk,'' to those cases where we are making a comparison to a CPT
code with the identical work RVU.
We look forward to continuing to engage with stakeholders and
commenters, including the RUC, as we prioritize our obligation to value
new, revised, and potentially misvalued codes; and will continue to
welcome feedback from all interested parties regarding valuation of
services for consideration through our rulemaking process. We refer
readers to the detailed discussion in this section of the final
valuation considered for specific codes. Table 13 contains a list of
codes for which we are finalizing work RVUs; this includes all codes
for which we received RUC recommendations by February 10, 2018. The
finalized work RVUs, work time and other payment information for all CY
2019 payable codes are available on the CMS website under downloads for
the CY 2019 PFS final rule at https://www.cms.gov/Medicare/Medicare-
Fee-for-Service-Payment/PhysicianFeeSched/). Table 13 also
contains the CPT code descriptors for all new, revised, and potentially
misvalued codes discussed in this section.

[[Page 59516]]

3. Methodology for the Direct PE Inputs To Develop PE RVUs
a. Background
On an annual basis, the RUC provides us with recommendations
regarding PE inputs for new, revised, and potentially misvalued codes.
We review the RUC-recommended direct PE inputs on a code by code basis.
Like our review of recommended work RVUs, our review of recommended
direct PE inputs generally includes, but is not limited to, a review of
information provided by the RUC, HCPAC, and other public commenters,
medical literature, and comparative databases, as well as a comparison
with other codes within the PFS, and consultation with physicians and
health care professionals within CMS and the federal government, as
well as Medicare claims data. We also assess the methodology and data
used to develop the recommendations submitted to us by the RUC and
other public commenters and the rationale for the recommendations. When
we determine that the RUC's recommendations appropriately estimate the
direct PE inputs (clinical labor, disposable supplies, and medical
equipment) required for the typical service, are consistent with the
principles of relativity, and reflect our payment policies, we use
those direct PE inputs to value a service. If not, we refine the
recommended PE inputs to better reflect our estimate of the PE
resources required for the service. We also confirm whether CPT codes
should have facility and/or nonfacility direct PE inputs and refine the
inputs accordingly.
Our review and refinement of RUC-recommended direct PE inputs
includes many refinements that are common across codes, as well as
refinements that are specific to particular services. Table 14 details
our refinements of the RUC's direct PE recommendations at the code-
specific level. In this final rule, we address several refinements that
are common across codes, and refinements to particular codes are
addressed in the portions of this section that are dedicated to
particular codes. We note that for each refinement, we indicate the
impact on direct costs for that service. We note that, on average, in
any case where the impact on the direct cost for a particular
refinement is $0.30 or less, the refinement has no impact on the PE
RVUs. This calculation considers both the impact on the direct portion
of the PE RVU, as well as the impact on the indirect allocator for the
average service. We also note that nearly half of the refinements
listed in Table 14 result in changes under the $0.30 threshold and are
unlikely to result in a change to the RVUs.
We also note that the finalized direct PE inputs for CY 2019 are
displayed in the CY 2019 direct PE input database, available on the CMS
website under the downloads for the CY 2019 PFS final rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. The inputs
displayed there have been used in developing the final CY 2019 PE RVUs
as displayed in Addendum B.
b. Common Refinements
(1) Changes in Work Time
Some direct PE inputs are directly affected by revisions in work
time. Specifically, changes in the intraservice portions of the work
time and changes in the number or level of postoperative visits
associated with the global periods result in corresponding changes to
direct PE inputs. The direct PE input recommendations generally
correspond to the work time values associated with services. We believe
that inadvertent discrepancies between work time values and direct PE
inputs should be refined or adjusted in the establishment of proposed
direct PE inputs to resolve the discrepancies.
(2) Equipment Time
Prior to CY 2010, the RUC did not generally provide CMS with
recommendations regarding equipment time inputs. In CY 2010, in the
interest of ensuring the greatest possible degree of accuracy in
allocating equipment minutes, we requested that the RUC provide
equipment times along with the other direct PE recommendations, and we
provided the RUC with general guidelines regarding appropriate
equipment time inputs. We appreciate the RUC's willingness to provide
us with these additional inputs as part of its PE recommendations.
In general, the equipment time inputs correspond to the service
period portion of the clinical labor times. We clarified this principle
over several years of rulemaking, indicating that we consider equipment
time as the time within the intraservice period when a clinician is
using the piece of equipment plus any additional time that the piece of
equipment is not available for use for another patient due to its use
during the designated procedure. For those services for which we
allocate cleaning time to portable equipment items, because the
portable equipment does not need to be cleaned in the room where the
service is furnished, we do not include that cleaning time for the
remaining equipment items, as those items and the room are both
available for use for other patients during that time. In addition,
when a piece of equipment is typically used during follow-up
postoperative visits included in the global period for a service, the
equipment time would also reflect that use.
We believe that certain highly technical pieces of equipment and
equipment rooms are less likely to be used during all of the preservice
or postservice tasks performed by clinical labor staff on the day of
the procedure (the clinical labor service period) and are typically
available for other patients even when one member of the clinical staff
may be occupied with a preservice or postservice task related to the
procedure. We also note that we believe these same assumptions would
apply to inexpensive equipment items that are used in conjunction with
and located in a room with non-portable highly technical equipment
items since any items in the room in question would be available if the
room is not being occupied by a particular patient. For additional
information, we refer readers to our discussion of these issues in the
CY 2012 PFS final rule with comment period (76 FR 73182) and the CY
2015 PFS final rule with comment period (79 FR 67639).
(3) Standard Tasks and Minutes for Clinical Labor Tasks
In general, the preservice, intraservice, and postservice clinical
labor minutes associated with clinical labor inputs in the direct PE
input database reflect the sum of particular tasks described in the
information that accompanies the RUC-recommended direct PE inputs,
commonly called the ``PE worksheets.'' For most of these described
tasks, there is a standardized number of minutes, depending on the type
of procedure, its typical setting, its global period, and the other
procedures with which it is typically reported. The RUC sometimes
recommends a number of minutes either greater than or less than the
time typically allotted for certain tasks. In those cases, we review
the deviations from the standards and any rationale provided for the
deviations. When we do not accept the RUC-recommended exceptions, we
refine the proposed direct PE inputs to conform to the standard times
for those tasks. In addition, in cases when a service is typically
billed with an E/M service, we remove the preservice clinical labor
tasks to avoid duplicative inputs and to reflect the resource costs of
furnishing the typical service.
We refer readers to section II.B. of this final rule, Determination
of Practice

[[Page 59517]]

Expense Relative Value Units (PE RVUs), for more information regarding
the collaborative work of CMS and the RUC in improvements in
standardizing clinical labor tasks.
(4) Recommended Items That Are Not Direct PE Inputs
In some cases, the PE worksheets included with the RUC's
recommendations include items that are not clinical labor, disposable
supplies, or medical equipment or that cannot be allocated to
individual services or patients. We addressed these kinds of
recommendations in previous rulemaking (78 FR 74242), and we do not use
items included in these recommendations as direct PE inputs in the
calculation of PE RVUs.
(5) New Supply and Equipment Items
The RUC generally recommends the use of supply and equipment items
that already exist in the direct PE input database for new, revised,
and potentially misvalued codes. Some recommendations, however, include
supply or equipment items that are not currently in the direct PE input
database. In these cases, the RUC has historically recommended that a
new item be created and has facilitated our pricing of that item by
working with the specialty societies to provide us copies of sales
invoices. For CY 2019, we received invoices for several new supply and
equipment items. Tables 14 and 15 detail the invoices received for new
and existing items in the direct PE database. As discussed in section
II.B. of this final rule, we encouraged stakeholders to review the
prices associated with these new and existing items to determine
whether these prices appear to be accurate. Where prices appear
inaccurate, we encouraged stakeholders to submit invoices or other
information to improve the accuracy of pricing for these items in the
direct PE database by February 10th of the following year for
consideration in future rulemaking, similar to our process for
consideration of RUC recommendations.
We remind stakeholders that due to the relativity inherent in the
development of RVUs, reductions in existing prices for any items in the
direct PE database increase the pool of direct PE RVUs available to all
other PFS services. Tables 14 and 15 also include the number of
invoices received and the number of nonfacility allowed services for
procedures that use these equipment items. We provide the nonfacility
allowed services so that stakeholders will note the impact the
particular price might have on PE relativity, as well as to identify
items that are used frequently, since we believe that stakeholders are
more likely to have better pricing information for items used more
frequently. A single invoice may not be reflective of typical costs and
we encourage stakeholders to provide additional invoices so that we
might identify and use accurate prices in the development of PE RVUs.
In some cases, we do not use the price listed on the invoice that
accompanies the recommendation because we identify publicly available
alternative prices or information that suggests a different price is
more accurate. In these cases, we include this in the discussion of
these codes. In other cases, we cannot adequately price a newly
recommended item due to inadequate information. Sometimes, no
supporting information regarding the price of the item has been
included in the recommendation. In other cases, the supporting
information does not demonstrate that the item has been purchased at
the listed price (for example, vendor price quotes instead of paid
invoices). In cases where the information provided on the item allows
us to identify clinically appropriate proxy items, we might use
existing items as proxies for the newly recommended items. In other
cases, we included the item in the direct PE input database without any
associated price. Although including the item without an associated
price means that the item does not contribute to the calculation of the
final PE RVU for particular services, it facilitates our ability to
incorporate a price once we obtain information and are able to do so.
(6) Service Period Clinical Labor Time in the Facility Setting
Generally speaking, our direct PE inputs do not include clinical
labor minutes assigned to the service period because the cost of
clinical labor during the service period for a procedure in the
facility setting is not considered a resource cost to the practitioner
since Medicare makes separate payment to the facility for these costs.
We address proposed code-specific refinements to clinical labor in the
individual code sections.
(7) Procedures Subject to the Multiple Procedure Payment Reduction
(MPPR) and the OPPS Cap
We note that the public use files for the PFS proposed and final
rules for each year display the services subject to the MPPR lists on
diagnostic cardiovascular services, diagnostic imaging services,
diagnostic ophthalmology services, and therapy services. We also
include a list of procedures that meet the definition of imaging under
section 1848(b)(4)(B) of the Act, and therefore, are subject to the
OPPS cap for the upcoming calendar year. The public use files for CY
2019 are available on the CMS website under downloads for the CY 2019
PFS final rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. For more
information regarding the history of the MPPR policy, we refer readers
to the CY 2014 PFS final rule with comment period (78 FR 74261-74263).
For more information regarding the history of the OPPS cap, we refer
readers to the CY 2007 PFS final rule with comment period (71 FR 69659-
69662).
4. Valuation of Specific Codes for CY 2019
(1) Fine Needle Aspiration (CPT Codes 10021, 10004, 10005, 10006,
10007, 10008, 10009, 10010, 10011, 10012, 76492, 77002 and 77021)
CPT code 10021 was identified as part of the OPPS cap payment
proposal in CY 2014 (78 FR 74246-74248), and it was reviewed by the RUC
for direct PE inputs only as part of the CY 2016 rule cycle.
Afterwards, CPT codes 10021 and 10022 were referred to the CPT
Editorial Panel to consider adding additional clarifying language to
the code descriptors and to include bundled imaging guidance due to the
fact that imaging had become typical with these services. In June 2017,
the CPT Editorial Panel deleted CPT code 10022, revised CPT code 10021,
and created nine new codes to describe fine needle aspiration
procedures with and without imaging guidance. These ten codes were
surveyed and reviewed for the October 2017 and January 2018 RUC
meetings. Several imaging services were also reviewed along with the
rest of the code family, although only CPT code 77021 was subject to a
new survey.
For CY 2019, we proposed the RUC-recommended work RVU for seven of
the ten codes in this family. Specifically, we proposed a work RVU of
0.80 for CPT code 10004 (Fine needle aspiration biopsy; without imaging
guidance; each additional lesion), a work RVU of 1.00 for CPT code
10006 (Fine needle aspiration biopsy, including ultrasound guidance;
each additional lesion), a work RVU of 1.81 for CPT code 10007 (Fine
needle aspiration biopsy, including fluoroscopic guidance; first
lesion), a work RVU of 1.18 for CPT code 10008 (Fine needle aspiration
biopsy, including fluoroscopic guidance; each additional lesion), and a
work RVU of

[[Page 59518]]

1.65 for CPT code 10010 (Fine needle aspiration biopsy, including CT
guidance; each additional lesion). We also proposed to assign the
recommended contractor-priced status to CPT codes 10011 (Fine needle
aspiration biopsy, including MR guidance; first lesion) and 10012 (Fine
needle aspiration biopsy, including MR guidance; each additional
lesion) due to low utilization until these services are more widely
utilized. In addition, we proposed the recommended work RVU of 1.50 for
CPT code 77021 (Magnetic resonance guidance for needle placement (e.g.,
for biopsy, fine needle aspiration biopsy, injection, or placement of
localization device) radiological supervision and interpretation), as
well as proposed to reaffirm the current work RVUs of 0.67 for CPT code
76942 (Ultrasonic guidance for needle placement (e.g., biopsy, fine
needle aspiration biopsy, injection, localization device), imaging
supervision and interpretation) and 0.54 for 77002 (Fluoroscopic
guidance for needle placement (e.g., biopsy, fine needle aspiration
biopsy, injection, localization device)).
We disagreed with the RUC-recommended work RVU of 1.20 for CPT code
10021 (Fine needle aspiration biopsy; without imaging guidance; first
lesion) and proposed a work RVU of 1.03 based on a direct crosswalk to
CPT code 36440 (Push transfusion, blood, 2 years or younger). CPT code
36440 is a recently reviewed code with the same intraservice time of 15
minutes and 2 additional minutes of total time. In reviewing CPT code
10021, we noted that the recommended intraservice time is decreasing
from 17 minutes to 15 minutes (12 percent reduction), and the
recommended total time is decreasing from 48 minutes to 33 minutes (32
percent reduction); however, the RUC-recommended work RVU is only
decreasing from 1.27 to 1.20, which is a reduction of just over 5
percent. Although we did not imply that the decrease in time as
reflected in survey values must equate to a one-to-one or linear
decrease in the valuation of work RVUs, we believe that since the two
components of work are time and intensity, significant decreases in
time should be appropriately reflected in decreases to work RVUs. In
the case of CPT code 10021, we believed that it was more accurate to
propose a work RVU of 1.03 based on a crosswalk to CPT code 36440 to
account for these decreases in the surveyed work time.
We disagreed with the RUC-recommended work RVU of 1.63 for CPT code
10005 (Fine needle aspiration biopsy, including ultrasound guidance;
first lesion) and proposed a work RVU of 1.46. Although we disagreed
with the RUC-recommended work RVU, we concurred that the relative
difference in work between CPT codes 10021 and 10005 is equivalent to
the recommended interval of 0.43 RVUs. Therefore, we proposed a work
RVU of 1.46 for CPT code 10005, based on the recommended interval of
0.43 additional RVUs above our proposed work RVU of 1.03 for CPT code
10021. The proposed increment of 0.43 RVUs above CPT code 10021 was
also based on the use of two crosswalk codes: CPT code 99225
(Subsequent observation care, per day, for the evaluation and
management of a patient, which requires at least 2 of 3 key
components); and CPT code 99232 (Subsequent hospital care, per day, for
the evaluation and management of a patient, which requires at least 2
of 3 key components). Both of these codes have the same intraservice
time and 1 additional minute of total time as compared with CPT code
10005, and both crosswalk codes share a work RVU of 1.39.
We disagreed with the RUC-recommended work RVU of 2.43 for CPT code
10009 (Fine needle aspiration biopsy, including CT guidance; first
lesion) and we proposed a work RVU of 2.26. Although we disagreed with
the RUC-recommended work RVU, we concurred that the relative difference
in work between CPT codes 10021 and 10009 is equivalent to the
recommended interval of 1.23 RVUs. Therefore, we proposed a work RVU of
2.26 for CPT code 10009, based on the recommended interval of 1.23
additional RVUs above our proposed work RVU of 1.03 for CPT code 10021.
The proposed use of the recommended increment from CPT code 10021 was
also based on the use of a crosswalk to CPT code 74263 (Computed
tomographic (CT) colonography, screening, including image
postprocessing), another CT procedure with 38 minutes of intraservice
time and 50 minutes of total time at a work RVU of 2.28.
We noted that the recommended work pool is increasing by
approximately 20 percent for the Fine Needle Aspiration family as a
whole, while the recommended work time pool for the same codes is only
increasing by about 2 percent. Since time is defined as one of the two
components of work, we believed that this indicated a discrepancy in
the recommended work values. We do not believe that the recoding of the
services in this family has resulted in an increase in their intensity,
only a change in the way in which they will be reported, and therefore,
we do not believe that it would serve the interests of relativity to
propose the recommended work values for all of the codes in this
family. We believe that, generally speaking, the recoding of a family
of services should maintain the same total work pool, as the services
themselves are not changing, only the coding structure under which they
are being reported. We also noted that through the bundling of some of
these frequently reported services, it is reasonable to expect that the
new coding system will achieve savings via elimination of duplicative
assumptions of the resources involved in furnishing particular
servicers. For example, a practitioner will not be carrying out the
full preservice work twice for CPT codes 10022 and 76942, but
preservice times were assigned to both of the codes under the old
coding. We believe the new coding assigns more accurate work times and
thus reflects efficiencies in resource costs that existed regardless of
how the services were previously reported.
For the direct PE inputs, we proposed to refine the clinical labor
time for the ``Prepare room, equipment and supplies'' (CA013) activity
to 3 minutes and to refine the clinical labor time for the ``Confirm
order, protocol exam'' (CA014) activity to 0 minutes for CPT code
77021. This code did not previously have clinical labor time assigned
for the ``Confirm order, protocol exam'' clinical labor task, and we do
not have any reason to believe that the services being furnished by the
clinical staff have changed, only the way in which this clinical labor
time has been presented on the PE worksheets. We also noted that there
is no effect on the total clinical labor direct costs in these
situations, since the same 3 minutes of clinical labor time is still
being furnished. We also proposed to refine the equipment times in
accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on
our proposals involving the Fine Needle Aspiration family of codes.
Comment: Several commenters disagreed with the CMS statement in the
proposed rule that the RUC-recommended work pool was increasing by
approximately 20 percent for this family of codes. Commenters stated
that the work pool based on the RUC-recommended values would actually
decrease by 15 percent and that the CMS work valuations were based on a
flawed methodology that did not account for the associated savings with
bundling the image guidance codes. One of the commenters supplied a
table with data to support the claim that the work

[[Page 59519]]

pool based on the RUC-recommended values would decrease by 15 percent
rather than increasing by 20 percent.
Response: We disagree with the commenters that the work pool would
decrease by 15 percent if we were to finalize the RUC recommendations.
We investigated the data in the table submitted by the commenters, and
we believe that there are several methodological flaws in the analysis
it contains. First, there are a number of 0.00 work RVUs listed in the
``RUC Recommended RVUs'' column for the new codes, which results in an
incorrect amount of ``New/Rev Total RVUs'' when multiplied by the
utilization for the new codes. As an example, CPT code 10005 has
approximately 135,000 services that are counted as having a work RVU of
0.00 in this table instead of the RUC-recommended work RVU of 1.63,
which undercounts the total number of RVUs by a wide margin. Second,
the values in the ``Total Source RVUs'' include the ratios from the
utilization crosswalk (listed on the table as ``Percent''). We do not
understand why these ratios would be used to calculate the total source
RVUs, as this side of the work pool comparison is calculated from the
utilization of the source codes times the work RVUs of the source
codes. Third, the imaging guidance codes are not fully included in both
sides of the comparison on this table, with their work RVUs included in
the source RVU total but not in the new/revised RVU total. This uneven
comparison results in an inaccurate tally of the work pools from before
and after the coding revisions take place.
In the interest of providing transparency, we are including Table
12 with our work pool comparison for the Fine Needle Aspiration code
family.

Table 12--Fine Needle Aspiration Work Pool Comparison
--------------------------------------------------------------------------------------------------------------------------------------------------------
Utilization Utilization Work RVU Work pool Work RVU Work pool Work pool Work pool %
HCPCS code source destination source source destination destination RVU change change
--------------------------------------------------------------------------------------------------------------------------------------------------------
10021................................... 23,755 21,380 1.27 30,169 1.20 25,655 -4,513 -15
10004................................... 0 2,376 0.00 0 0.80 1,900 1,900 ............
10005................................... 0 270,753 0.00 0 1.63 441,327 441,327 ............
10006................................... 0 30,621 0.00 0 1.00 30,621 30,621 ............
10007................................... 0 6,857 0.00 0 1.81 12,411 12,411 ............
10008................................... 0 873 0.00 0 1.18 1,030 1,030 ............
10009................................... 0 60,665 0.00 0 2.43 147,416 147,416 ............
10010................................... 0 6,831 0.00 0 1.65 11,271 11,271 ............
10011................................... 0 83 0.00 0 C 0 0 ............
10012................................... 0 3 0.00 0 C 0 0 ............
10022................................... 186,455 0 1.27 236,798 0.00 0 -236,798 -100
76942................................... 558,081 488,321 0.67 373,914 0.67 327,175 -46,739 -13
7694226................................. 641,346 561,178 0.67 429,702 0.67 375,989 -53,713 -13
76942TC................................. 8,588 7,515 0.00 0 0.00 0 0 ............
77002................................... 311,280 308,790 0.54 168,091 0.54 166,746 -1,345 -1
7700226................................. 180,964 179,516 0.54 97,721 0.54 96,939 -782 -1
77002TC................................. 7,936 7,873 0.00 0 0.00 0 0 ............
77012................................... 9,343 7,792 1.16 10,838 1.50 11,688 850 8
7701226................................. 194,611 162,306 1.16 225,749 1.50 243,458 17,710 8
77012TC................................. 469 391 0.00 0 0.00 0 0 ............
77021................................... 1,481 1,432 1.50 2,222 1.50 2,148 -73 -3
7702126................................. 1,038 1,004 1.50 1,557 1.50 1,506 -51 -3
77021TC................................. 67 65 0.00 0 0.00 0 0 ............
---------------------------------------------------------------------------------------------------------------
Totals.............................. 2,125,414 2,126,622 ............ 1,576,760 ............ 1,897,282 320,523 20
--------------------------------------------------------------------------------------------------------------------------------------------------------

We continue to believe that the RUC-recommended work pool is
increasing by approximately 20 percent for the Fine Needle Aspiration
family as a whole, and that this percentage increase suggests that CPT
codes 10021, 10005, and 10009 are more accurately valued at the CMS
proposed work RVUs.
Comment: Several commenters disagreed that this code family will
achieve savings via elimination of duplicative assumptions of the
resources involved in furnishing particular services. Commenters stated
that there is no overlap between the current descriptions of work for
the bundled codes, and that CPT code 10022 is never performed on the
same patient without an image guidance code and the image guidance
codes are never performed on the same patient without a corresponding
procedure code. The commenters stated that any associated reduction in
payment would be due to other factors, not due to the code bundling.
Response: We disagree with the commenters that there would be no
savings achieved via elimination of duplicative assumptions of the
resources involved in furnishing particular services. As we stated in
the proposed rule, a practitioner will not be carrying out the full
preservice work twice for CPT codes 10022 and 76942, but preservice
times were assigned to both of the codes under the old coding. In
similar fashion, these codes both separately include immediate
postservice work time for dictating a report in their clinical
vignettes. This is an example of how savings are achieved via
elimination of duplicative assumptions of resources, as the
practitioner will only dictate a single report in the newly created CPT
code 10005 that bundles these two services together. We continue to
believe that the new coding assigns more accurate work times and thus
reflects efficiencies in resource costs that existed regardless of how
the services were previously reported.
Comment: One commenter stated that while it may be true
mathematically that the work pool for this family of codes was
increasing by 20 percent, using this observation as the sole basis to
implement work value relies on incorrect assumptions which do not
adhere to current relativity-based RUC methodologies. The commenter
stated that the rationale proposed by CMS incorrectly implies that the
decrease in time as reflected in survey values must equate to a one to
one or linear decrease in the valuation of work RVUs and fails to
recognize changes in intensity that have taken place over time.
Response: We disagree with the commenter that our analysis of
changes in the work pool for this family of codes was the sole basis
for the proposed refinements to the work RVUs. While

[[Page 59520]]

this was an important factor in our analysis of the work valuation of
individual codes, we also detailed in the proposed rule our use of time
ratios, increments, and crosswalk codes as part of our larger
methodology to determine work RVUs. We specifically stated that we did
not imply that the decrease in time as reflected in survey values must
equate to a one-to-one or linear decrease in the valuation of work
RVUs, but rather that we believe that since the two components of work
are time and intensity, significant decreases in time should be
appropriately reflected in decreases to work RVUs. We do consider
changes in intensity that have taken place over time as part of our
analysis of work valuation, as demonstrated by the fact that we
proposed the RUC-recommended work RVUs for seven of the ten codes in
this family.
Comment: One commenter disagreed that the work pool for a family of
revised codes should be similar before and after the valuation of the
new codes. The commenter stated that by separating different modalities
into their own codes, the appropriate time and intensity differences
for these services were more accurately reflected in the recommended
RVUs, and the work pool appropriately expanded to reflect these
differences. The commenter cited the example of CPT code 10022 being
unable to account for different patients receiving a biopsy using
ultrasound or CT technology.
Response: We agree with the commenter that the work pool for a
revised code family does not always need to be similar before and after
the valuation of the new codes. However, the commenter did not address
our rationale for why we believe that an increase in the work pool
would be inaccurate for this particular family of codes, which was
based on the observation that the RUC-recommended work pool was
increasing by approximately 20 percent while the RUC-recommended work
time pool for the same codes was only increasing by about 2 percent. In
a situation where prior coding was unable to account for newer and more
complex forms of treatment, we would expect the work time pool to
expand alongside the work pool, since these more complex and intensive
procedures would take more time to furnish.
Comment: A few commenters stated that since CMS changed the
multiple procedure indicator from ``0'' to ``2'' for all Fine Needle
Aspiration biopsy initial lesion codes for CY 2019, the commenter
believes that using XXX global codes as references was incorrect. The
commenter instead recommended that CMS review similar minor procedures
that have a 0-day global designation, which suggested that a higher
work RVU could have been supported.
Response: We continue to believe that codes should generally be
compared to codes with the same global period. Codes with a 0-day
global period bundle other services that take place on the same day as
the procedure into the valuation of the code, whereas such bundling is
not included in codes with an XXX global period. We do not agree that
it would have been more accurate to use codes with a 0-day global
period as references for the codes in this family.
Comment: Many commenters disagreed with the proposed work RVU of
1.03 for CPT code 10021 and stated that CMS should finalize the RUC-
recommended work RVU of 1.20. Commenters stated that this service has a
new coding structure as compared to the past, and that the prior review
was last carried out in 1995 when physician work time was evaluated
with much less rigor. Commenters stated that the old time values were
also based on a crosswalk and not a survey, and that therefore the drop
in work time did not warrant a proportional change in work RVU as the
previous times were inaccurate.
Response: We agree that it is important to use the most recent data
available regarding time, and we note that when many years have passed
between when time is measured, significant discrepancies can occur.
However, we also believe that our operating assumption regarding the
validity of the existing values as a point of comparison is critical to
the integrity of the relative value system as currently constructed.
The times currently associated with codes play a very important role in
PFS ratesetting, both as points of comparison in establishing work RVUs
and in the allocation of indirect PE RVUs by specialty. If we were to
operate under the assumption that previously recommended work times had
routinely been overestimated, this would undermine the relativity of
the work RVUs on the PFS in general, given the process under which
codes are often valued by comparisons to codes with similar times, and
it also would undermine the validity of the allocation of indirect PE
RVUs to physician specialties across the PFS. Instead, we believe that
it is crucial that the code valuation process take place with the
understanding that the existing work times used in the PFS ratesetting
processes are accurate. We recognize that adjusting work RVUs for
changes in time is not always a straightforward process and that the
intensity associated with changes in time is not necessarily always
linear, which is why we apply various methodologies to identify several
potential work values for individual codes. However, we want to
reiterate that we believe it would be irresponsible to ignore changes
in time based on the best data available and that we are statutorily
obligated to consider both time and intensity in establishing work RVUs
for PFS services. For additional information regarding the use of prior
work time values in our methodology, we refer readers to our discussion
of the subject in the CY 2017 PFS final rule (81 FR 80273 through
80274).
Comment: Several commenters stated the CMS rationale for the
proposed work RVU for CPT code 10021 incorrectly implies that the
decreased time reflected in survey values should have a one-to-one
decrease in value, or a linear decrease in the valuation of work RVUs.
Commenters stated that CMS incorrectly assumed that there are no
differences in how work was valued in 1995 and how it is valued now.
Response: We do not agree with the commenters' characterization of
our statements, and believe it misinterprets our view on this matter.
We specifically stated in the CY 2019 PFS proposed rule that we were
not implying that the decrease in time as reflected in survey values
must necessarily equate to a one-to-one or linear decrease in the
valuation of work RVUs, both generally speaking and with regards to
this particular CPT code (83 FR 35747). We recognize that intensity for
any given procedure may change over several years or within the
intraservice period. Nevertheless, since the two components of work are
time and intensity, we believe that absent an obvious or explicitly
stated rationale for why the relative intensity of a given procedure
has specifically increased or the reduction in time occurs
disproportionally in the less-intensive portions of the procedure,
significant decreases in time should generally be reflected as
decreases to work RVUs.
Comment: Several commenters disagreed with the use of CPT code
36440 as a crosswalk for the work RVU of CPT code 10021. Commenters
stated that there were differences in site of service, patient
population, and utilization between these two codes, which made CPT
code 36440 a poor choice to use for work valuation. One commenter
stated that CPT code 36440 is used to report a push transfusion of
blood through an already established

[[Page 59521]]

access in a vessel, and does not carry the same risk and intensity as
CPT code 10021, which involves accessing a lesion in the neck multiple
times to aspirate biopsy specimens. Commenters supplied a chart
depicting several comparator codes for 10021 that they stated were more
appropriate choices for a crosswalk.
Response: We disagree with the commenters that CPT code 36440 is an
inappropriate choice for a crosswalk code. While it is true that this
code is typically performed on an inpatient basis and the patient
population comprises neonates instead of adults, we note that these
factors suggest that the patient population for CPT code 36440 is
likely sicker and more complex than the patient population for CPT code
10021. These differences would, if anything, be grounds for a lower
work RVU for CPT code 10021, not a higher work RVU. We continue to
believe that CPT code 36440 is an appropriate choice for a crosswalk
due to the highly similar work times and intensity as compared to CPT
code 10021. As for the other comparator codes provided by the
commenters, we do not agree that they would be more appropriate choices
for a crosswalk as we believe that they have a higher intensity than
the service described by CPT code 10021. In more general terms, we
continue to believe that the nature of the PFS relative value system
necessarily involves comparisons of all services to one another.
Although codes that describe clinically similar services are sometimes
stronger comparator codes, we do not agree that codes must share the
same site of service, patient population, or utilization level to serve
as an appropriate crosswalk.
Comment: Many commenters disagreed with the proposed work RVU of
1.46 for CPT code 10005 and stated that CMS should finalize the RUC-
recommended work RVU of 1.63. Commenters stated that CMS should use
valid methods of evaluating services, such as survey data and magnitude
estimation, instead of relying on an incremental difference in work
RVUs between CPT codes 10021 and 10005.
Response: We believe the use of an incremental difference between
codes is a valid methodology for setting values, especially in valuing
services within a family of revised codes where it is important to
maintain appropriate intra-family relativity. Historically, we have
frequently utilized an incremental methodology in which we value a code
based upon its incremental difference between another code or another
family of codes. We note that the RUC has also used the same
incremental methodology on occasion when it was unable to produce valid
survey data for a service. We further note that we did not rely solely
on an increment for our proposed work RVU for CPT code 10005,
supporting our proposed valuation with the use of two reference codes:
CPT codes 99225 and 99232. Both of these codes have the same
intraservice time and 1 additional minute of total time as compared
with CPT code 10005, and both reference codes share a work RVU of 1.39.
Comment: One commenter stated that they did not object to the CMS
designation of 0.43 RVUs as the increment over CPT code 10021 for
adding ultrasound guidance; however, the commenter objected to the
assumption that the work value for CPT code 36440 offers an acceptable
baseline.
Response: We continue to believe that a crosswalk to the work RVU
of CPT code 36440 produces the most accurate valuation for baseline CPT
code 10021.
Comment: Commenters disagreed with the proposed work RVU of 2.26
for CPT code 10009 and stated that CMS should finalize the RUC-
recommended work RVU of 2.43. Commenters provided similar comments for
CPT code 10009 as they provided for CPT code 10005, suggesting that the
use of an incremental methodology was inaccurate and that CMS should
use more valid methods of evaluating services, such as survey data and
magnitude estimation.
Response: We continue to disagree with the commenters that the use
of an increment is a less valid methodology for valuing services. As
detailed in the response to the comment summary above for CPT code
10005, we believe the use of an incremental difference is appropriate,
especially in valuing services within a family of revised codes where
it is important to maintain appropriate intra-family relativity. We
further note that we did not rely solely on an increment for our
proposed work RVU for CPT code 10009, supporting our proposed valuation
with the use of a reference to CPT code 74263.
Comment: A commenter stated that in the CMS refinements to the
direct PE inputs for CPT codes 77012 and 77021, CMS proposed to remove
1 minute from the CA014 activity code and proposed to add 1 minute to
the CA013 activity code. The commenter stated that this refinement was
inaccurate and encouraged CMS to modify this proposal by finalizing the
RUC-recommended direct PE inputs for clinical labor.
Response: We address this subject in detail in the PE section of
this final rule under the Changes to Direct PE Inputs for Specific
Services heading (section II.B.3. of this final rule). For CPT codes
77012 and 77021, we are finalizing these clinical labor refinements as
proposed.
After consideration of the public comments, we are finalizing the
work RVUs and direct PE inputs for all of the codes in the Fine Needle
Aspiration family as proposed.
(2) Biopsy of Nail (CPT Code 11755)
CPT code 11755 (Biopsy of nail unit (e.g., plate, bed, matrix,
hyponychium, proximal and lateral nail folds) (separate procedure)) was
identified as potentially misvalued on a screen of 0-day global
services reported with an E/M visit 50 percent of the time or more, on
the same day of service by the same patient and the same practitioner,
that have not been reviewed in the last 5 years with Medicare
utilization greater than 20,000. For CY 2019, the HCPAC recommended a
work RVU of 1.25 based on the survey median value.
We disagreed with the recommended value and proposed a work RVU of
1.08 for CPT code 11755 based on the survey 25th percentile value. We
noted that the recommended intraservice time for CPT code 11755 is
decreasing from 25 minutes to 15 minutes (40 percent reduction), and
the recommended total time for CPT code 11755 is decreasing from 55
minutes to 39 minutes (29 percent reduction); however, the recommended
work RVU is only decreasing from 1.31 to 1.25, which is a reduction of
less than 5 percent. Although we did not imply that the decrease in
time as reflected in survey values must equate to a one-to-one or
linear decrease in the valuation of work RVUs, we believe that since
the two components of work are time and intensity, significant
decreases in time should be reflected in decreases to work RVUs. In the
case of CPT code 11755, we believed that it would be more accurate to
propose the survey 25th percentile work RVU than the survey median to
account for these decreases in the surveyed work time.
The proposed work RVU of 1.08 is also based on a crosswalk to CPT
code 11042 (Debridement, subcutaneous tissue (includes epidermis and
dermis, if performed); first 20 sq cm or less), which has a work RVU of
1.01, the same intraservice time of 15 minutes, and a similar total
time of 36 minutes. We also noted that, generally speaking, working
with extremities like nails tends to be less intensive in clinical
terms than other services, especially as compared to surgical
procedures. We believe that

[[Page 59522]]

this further supports our proposal of a work RVU of 1.08 for CPT code
11755.
We proposed to refine the equipment times in accordance with our
standard equipment time formulas.
The following is a summary of the public comments we received on
our proposals involving CPT code 11755.
Comment: A few commenters stated that section 1848(c)(7) of the
Act, as amended by section 220(e) of the Protecting Access to Medicare
Act of 2014 (PAMA), specifies that for services that are not described
by new and revised codes, if the total RVU for a service would be
decreased by 20 percent or more as compared to the total RVUs for the
previous year, the applicable adjustments must be phased in over a 2-
year period. These commenters stated that, according to this
requirement, CPT code 11755 should be subject to the phase-in for CY
2019.
Response: We agree that CPT code 11755 should be subject to the
phase-in for CY 2019. Due to a technical error, we inadvertently
neglected to apply the phase-in to the total RVU of this code in the
facility setting for the proposed rule, and we are correcting this for
the final rule.
Comment: Many commenters disagreed with the proposed work RVU of
1.08 for CPT code 11755 and stated that CMS should finalize the RUC-
recommended work RVU of 1.25. Commenters urged CMS to view the survey
and the HCPAC's recommendation for the survey median work value of 1.25
apart from the current work time and work RVU because the primary
specialty that currently performs the service was not included in the
prior survey conducted in 1993.
Response: We disagree with the commenters that the current work
time and work RVU for CPT code 11755 should be viewed separately from
the new recommended values. We do not pay differentially for services
on the basis of specialty, and a change in the dominant specialty since
the time of the last survey is not a reason to disregard the current
work time and work RVUs in developing proposed work RVUs.
Comment: Commenters compared the proposed work RVU of CPT code
11755 to the work valuation of the top key reference service, CPT code
11730 (Avulsion of nail plate, partial or complete, simple; single).
Commenters stated that the increment of work between CPT code 11730 of
1.05 and the CMS proposed value for CPT code 11755 of 1.08 was only
0.03 RVUs, which was not enough to account for the additional work
involved in CPT code 11755 given that the latter code also had 50
percent more intraservice time. Commenters also expressed concerns with
the CMS reference to CPT code 11042 at a work RVU of 1.01, stating that
it required less physician work time and a less refined technique.
Commenters stated that the service described by CPT code 11755 was more
intense to perform because the physician has to be extremely careful
not to accidentally hit the patient's bone while taking the biopsy.
Commenters stated that the nail plate is typically difficult to remove
during the process of the biopsy performed in the service described by
CPT code 11755, and that the biopsy must be performed with extreme care
to avoid injury to the surgeon or extension of the incision to the
underlying bone, which carries the potential for an osteomyelitis and
significant post-operative pain. Commenters again urged CMS to finalize
the RUC-recommended values for this code.
Response: After reviewing the additional information about the
risks inherent in the service provided by the commenters, we agree that
it would be more accurate to finalize the RUC-recommended work RVU of
1.25 for CPT code 11755 to reflect the intensity of the procedure.
Comment: One commenter stated that CMS did not indicate what amount
of service period time was removed from the calculation of the
equipment time, and that this made it difficult to determine the
accuracy of the refinements. The commenter requested more information
about this change.
Response: For the basic instrument pack (EQ137) equipment, we
removed the clinical labor for the CA024, CA027, CA029, and CA035
clinical labor activities in accordance with our standard equipment
time formula for surgical instrument packs. For the other three
equipment items, we removed the clinical labor for the CA027 and CA035
clinical labor activity codes in accordance with our standard equipment
time formula for non-highly technical equipment.
After consideration of the public comments, we are finalizing the
RUC-recommended work RVU of 1.25 for CPT code 11755. We are finalizing
the direct PE inputs for this code as proposed.
(3) Skin Biopsy (CPT Codes 11102, 11103, 11104, 11105, 11106, and
11107)
In CY 2016, CPT codes 11100 (Biopsy of skin, subcutaneous tissue
and/or mucous membrane (including simple closure), unless otherwise
listed; single lesion) and 11101 (Biopsy of skin, subcutaneous tissue
and/or mucous membrane (including simple closure), unless otherwise
listed; each separate/additional lesion) were identified as potentially
misvalued using a high expenditure services screen across specialties
with Medicare allowed charges of $10 million or more. Prior to the
January 2016 RUC meeting, the specialty society notified the RUC that
its survey data displayed a bimodal distribution of responses with more
outliers than usual. The RUC referred CPT codes 11100 and 11101 to the
CPT Editorial Panel. In February 2017, the CPT Editorial Panel deleted
these two codes and created six new codes for primary and additional
biopsy based on the thickness of the sample and the technique utilized.
For CY 2019, we proposed the RUC-recommended work RVUs for five of
the six codes in the family. We proposed a work RVU of 0.66 for CPT
code 11102 (Tangential biopsy of skin, (e.g., shave, scoop, saucerize,
curette), single lesion), a work RVU of 0.83 for CPT code 11104 (Punch
biopsy of skin, (including simple closure when performed), single
lesion), a work RVU of 0.45 for CPT code 11105 (Punch biopsy of skin,
(including simple closure when performed), each separate/additional
lesion), a work RVU of 1.01 for CPT code 11106 (Incisional biopsy of
skin (e.g., wedge), (including simple closure when performed), single
lesion), and a work RVU of 0.54 for CPT code 11107 (Incisional biopsy
of skin (e.g., wedge), (including simple closure when performed), each
separate/additional lesion).
For CPT code 11103 (Tangential biopsy of skin, (e.g., shave, scoop,
saucerize, curette), each separate/additional lesion), we disagreed
with the RUC-recommended work RVU of 0.38 and proposed a work RVU of
0.29. When we compared the RUC-recommended work RVU of 0.38 to other
add-on codes in the RUC database, we found that CPT code 11103 would
have the second-highest work RVU for any code with 7 minutes or less of
total time, with the recommended work RVU noticeably higher than other
related add-on codes, and we did not agree that the tangential biopsy
service being performed should have an anomalously high work value in
comparison to other similar add-on codes. Our proposed work RVU of 0.29
was based on a crosswalk to CPT code 11201 (Removal of skin tags,
multiple fibrocutaneous tags, any area; each additional 10 lesions, or
part thereof), a clinically related add-on procedure with 5 minutes of
intraservice and total time as opposed to the surveyed 6 minutes for

[[Page 59523]]

CPT code 11103. We also noted that the intraservice time ratio between
CPT code 11103 and the recommended reference code, CPT code 11732
(Avulsion of nail plate, partial or complete, simple; each additional
nail plate), was 75 percent (6 minutes divided by 8 minutes). This 75
percent ratio when applied to the work RVU of CPT code 11732 also
produced a work RVU of 0.29 (0.38 * 0.75 = 0.29). Finally, we also
supported the proposed work RVU through a crosswalk to CPT code 33508
(Endoscopy, surgical, including video-assisted harvest of vein(s) for
coronary artery bypass procedure), which has a higher intraservice time
of 10 minutes but a similar work RVU of 0.31. We believed that our
proposed work RVU of 0.29 for CPT code 11103 better serves the
interests of relativity, as well as better fitting with the other
recommended work RVUs within this family of codes.
For the direct PE inputs, we proposed to remove the 2 minutes of
clinical labor time for the ``Review home care instructions, coordinate
visits/prescriptions'' (CA035) activity for CPT codes 11102, 11104, and
11106. These codes are typically billed with a same day E/M service,
and we believe that it would be duplicative to assign clinical labor
time for reviewing home care instructions given that this task would
typically be done during the same day E/M service. We also proposed to
refine the equipment times in accordance with our standard equipment
time formulas.
We proposed to refine the quantity of the ``gown, staff,
impervious'' (SB024) and the ``mask, surgical, with face shield''
(SB034) supplies from 2 to 1 for CPT codes 11102, 11104, and 11106. We
proposed to remove one gown and one surgical mask from these codes as
duplicative since these supplies are also included within the surgical
instrument cleaning pack (SA043). We also proposed to remove all of the
supplies in the three add-on procedures (CPT codes 11103, 11105, and
11107) that were not contained in the previous add-on procedure for
this family, CPT code 11101. We do not believe that the use of these
supplies would be typical for the ``each additional lesion'' add-on
codes, as these supplies are all included in the base codes and are not
currently utilized in CPT code 11101. We noted that the recommended
direct PE costs for the three new add-on codes represent an increase of
approximately 500 percent from the direct PE costs for CPT code 11101,
and believe that this is largely due to the addition of these new
supplies.
The following is a summary of the public comments we received on
our proposals involving the Skin Biopsy family of codes.
Comment: Many commenters disagreed with the proposed work RVU of
0.29 for CPT code 11103 and stated that CMS should finalize the RUC-
recommended work RVU of 0.38. Commenters disagreed that CPT code 11103
would have the second-highest work RVU for any code with 7 minutes or
less of total time, stating that the total number of add-on codes with
RUC total time of 7 minutes or less is 18. Commenters stated that only
five of these services have total time of 6 or 7 minutes and the rest
were lower, thus the majority of the work RVUs among these services
were lower and not comparable. Commenters stressed that the RUC-
recommended work RVU of 0.38 for CPT code 11103 was appropriate since
the service is performed on a separate site than the base code and
there is additional physician work to transition to a different site.
Commenters stated that the RUC's direct crosswalk to CPT code 11732
(Avulsion of nail plate, partial or complete, simple; each additional
nail plate), which describes procedures with significant physician
effort in removing a nail plate with its anesthesia and hemostasis
challenges, was a much better comparator to CPT code 11103 which
involves the biopsy of a vascular tumor, typically on the face.
Commenters stated that the proposed crosswalk to CPT code 11201 at a
work RVU of 0.29 was too low to maintain relativity within the family
of codes. One commenter stated that the type of skin biopsies performed
in CPT code 11103 can result in the detection of carcinoma, melanoma,
sarcoma/lymphoma, and other dangerous pathologies, and that making
these diagnoses can save lives and ultimately decrease Medicare
spending.
Response: After reviewing the additional information provided by
the commenters, we agree that it would be more accurate to finalize the
RUC-recommended work RVU of 0.38 for CPT code 11103 as the proposed
work RVU was too low to maintain relativity within the family of codes.
Comment: Commenters disagreed with many of the refinements made by
CMS to the direct PE inputs for this family of codes. Commenters stated
that it was not appropriate to only include equipment and supply items
in the new biopsy add-on codes that were included in the old add-on
code (CPT code 11101) because the old codes were not specific enough to
accurately distinguish between the three types of biopsies. Commenters
cited as an example the fact that the predecessor CPT code 11101 did
not include supply items that are necessary for the performance of the
incisional biopsy.
Response: We appreciate the feedback from the commenters clarifying
some of the differences between the predecessor code and the newly
created add-on codes. We evaluated these differences on an individual
case-by-case basis when determining whether or not to finalize the
proposed refinements to the direct PE inputs.
Comment: Several commenters disagreed with the proposed refinements
to the ``Review home care instructions, coordinate visits/
prescriptions'' (CA035) clinical labor time. Commenters stated that
home care instructions furnished in an E/M visit do not typically
include wound care instructions, and that this instruction would be
above and beyond instructions proved during an E/M visit in which no
procedure is performed.
Response: We disagree with the commenters that wound care
instructions would not be provided during the same day E/M visit. We
continue to believe that it would be duplicative to assign clinical
labor time for this task given the fact that a same day E/M visit is
typical for these services. We believe that these instructions would be
provided during the same day E/M visit.
Comment: Several commenters disagreed with the CMS proposal to
refine the quantity of the ``gown, staff, impervious'' (SB024) and the
``mask, surgical, with face shield'' (SB034) supplies from 2 to 1 for
CPT codes 11102, 11104, and 11106 since these supplies are also
included within the surgical instrument cleaning pack (SA043).
Commenters stated that the SA043 instrument cleaning pack is used in
the dirty instrument room as part of the instrument cleaning and
sterilization process and therefore cannot be used during a patient
procedure as the instrument cleaning occurs after the procedure has
been completed. Commenters stated that the personal protective
equipment used during the patient procedure is considered contaminated
after the procedure is concluded, and that personal protective
equipment must be removed and disposed of prior to leaving the
procedure room. As a result, these supplies were not duplicative and
should not be removed.
Response: We disagree with the commenter and we continue to believe
that the impervious staff gown and the surgical mask with face shield
would be duplicative supplies given that they are also contained within
the instrument cleaning pack. We do not believe that it

[[Page 59524]]

would be typical to remove the staff gown and face shield used during a
procedure and put on new items afterwards for the purposes of cleaning
instruments.
Comment: Commenters also disagreed with the CMS proposal to remove
all of the supplies in the three add-on procedures (CPT codes 11103,
11105, and 11107) that were not contained in the previous add-on
procedure for this family, CPT code 11101. For the ``drape, sterile,
fenestrated 16in x 29in'' (SB011) supply, commenters stated that
draping the new body site with a new sterile disposable drape was
clinically indicated and would be typically done rather than take a
drape used on one body site and then reposition it to a new body site
for a new procedure. Commenters made the same claim for the sterile
gloves (SB024) supply. For the ``needle, OSHA compliant (SafetyGlide)''
(SC080) and the ``scalpel, safety, surgical, with blade (#10-20)''
(SF047) supplies, commenters stated that the add-on represented a
completely new body site and completely new skin lesion which would not
allow the needle or scalpel to be un-sheathed and then reused at a
separate body site out of fear of contamination. For the ``dressing,
12-7mm (Gelfoam)'' (SG033), ``dressing, 3in x 4in (Telfa, Release)''
(SG035), and ``gauze, sterile 4in x 4in (10 pack uou)'' (SG056)
supplies, commenters stated that the add-on procedure is a second
biopsy of a completely different body location and that these
dressings/gauze pads would not be retained and then used on the second
procedure out of fear of contamination. For the ``tape, surgical paper
1in (Micropore)'' (SG079) supply, commenters stated that the quantity
of this supply in the base code was sufficient for one lesion, but not
more than one lesion due to the simple fact that two lesions required
more surgical tape than one lesion. Finally, for the ``swab, patient
prep, 1.5 ml (chloraprep)'' (SJ081) supply, commenters stated that the
process of skin prep starts with the center of the lesion and moves
outward in concentric circles to avoid bringing pathogens back into the
field. Commenters stated that the prep sponge cannot be reused on a
separate area of skin as it will contaminate that area by transporting
pathogens from the last concentric circle of the prior area, and that
the supply quantity in the base code contained an amount insufficient
to prep more than one area. Commenters requested CMS not to finalize
the proposal to remove these supplies from the add-on codes.
Response: After considering the new information provided by the
commenters regarding the clinical use of these supplies, we will not
finalize our proposal to remove these supplies from the three add-on
procedures (CPT codes 11103, 11105, and 11107). We will restore the
RUC-recommended supplies for these three codes.
Comment: Several commenters disagreed with the refinements to the
equipment time in CPT codes 11102, 11104, and 11106. The commenters
stated that the removal of 2 minutes of equipment time was not
appropriate and that equipment time needs to match clinical staff time.
Response: We agree with the commenter that changes in clinical
labor time should be matched with corresponding changes in equipment
time. However, since we continue to believe that the clinical labor to
the ``Review home care instructions, coordinate visits/prescriptions''
(CA035) clinical labor time should be removed as duplicative with the
same day E/M visit, we also continue to believe that the equipment
times are accurate as proposed.
After consideration of the public comments, we are finalizing the
RUC-recommended work RVUs for all of the codes in the Skin Biopsy
family. We are finalizing the direct PE inputs as proposed, with the
exception of the supplies from the three add-on procedures (CPT codes
11103, 11105, and 11107) as detailed above.
(4) Injection Tendon Origin-Insertion (CPT Code 20551)
CPT code 20551 (Injection(s); single tendon origin/insertion) was
identified as potentially misvalued on a screen of 0-day global
services reported with an E/M visit 50 percent of the time or more, on
the same day of service by the same patient and the same practitioner,
that have not been reviewed in the last 5 years with Medicare
utilization greater than 20,000. For CY 2019, we proposed the RUC-
recommended work RVU of 0.75 for CPT code 20551.
We proposed to maintain the current work RVU for many of the CPT
codes identified as potentially misvalued on the screen of 0-day global
services reported with an E/M visit 50 percent of the time or more. We
noted that regardless of the proposed work valuations for individual
codes, which may or may not retain the same work RVU, we continue to
have reservations about the valuation of 0-day global services that are
typically billed with a separate E/M service with the use of Modifier
25 (indicating that a significant and separately identifiable E/M
service was provided on the same day). As we stated in the CY 2017 PFS
final rule (81 FR 80204), we continue to believe that the routine
billing of separate E/M services in conjunction with a particular code
may indicate a possible problem with the valuation of the code bundle,
which is intended to include all the routine care associated with the
service. We will continue to consider additional ways to address the
appropriate valuation for these services.
For the direct PE inputs, we proposed to remove the clinical labor
time for the ``Provide education/obtain consent'' (CA011) and the
``Review home care instructions, coordinate visits/prescriptions''
(CA035) activities for CPT code 20551. This code is typically billed
with a same day E/M service, and we believe that it will be duplicative
to assign clinical labor time for obtaining consent or reviewing home
care instructions given that these tasks will typically be done during
the same day E/M service. We also proposed to refine the equipment
times in accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on
our proposals involving CPT code 20551.
Comment: A few commenters supported our proposal to maintain the
current work RVU for this code, as recommended by the RUC.
Response: We appreciate the support for our proposal from the
commenters.
Comment: Several commenters disagreed with the proposed direct PE
refinements to CPT code 20551. Commenters stated that they did not
agree that the clinical labor taking place in activity codes CA011 and
CA035 were duplicative and that the RUC is careful to remove any
duplication with E/M visits. Commenters stated that the home care
instructions in activity code CA035 refer directly to the tendon
injection and may include discussion of care for the affected area and
home restrictions. Commenters stated that this injection is more
involved and invasive than a vaccination such as the ones taking place
in CPT codes 90470 and 90471, which were allowed 3 minutes for ``F/u on
physician's discussion w/patient/parent & obtain actual consent
signature'' and an additional 3 minutes for home care instructions and
recording vaccine information.
Response: For the CA011 clinical labor activity, we agree with the
commenters that there would be a need for some additional time to
obtain consent for the injection, but we do not agree that it would be
typical to require the full 3 minutes because we believe there would be
some overlap with the same day E/M visit. In similar fashion, we
believe that there would also be some overlap with the same-day E/M

[[Page 59525]]

visit for the home care instructions described in activity code CA035.
We also note that there is 1 minute of clinical labor time assigned to
the ``Check dressings & wound/home care instructions/coordinate office
visits/prescriptions'' clinical labor task for CPT code 90471
referenced by the commenters. As a result, we are finalizing the
assignment of 1 minute of clinical labor time to both of the CA011 and
CA035 activities for CPT code 20551. We are also finalizing an increase
of 1 minute in the equipment time for the exam table (EF023) to a total
of 15 minutes, in accordance with our standard time formula for non-
highly technical equipment.
After consideration of the public comments, we are finalizing our
proposal to maintain the current work RVU for CPT code 20551. We are
finalizing the direct PE inputs with the refinements detailed above.
(5) Structural Allograft (CPT Codes 20932, 20933, and 20934)
In February 2017, the CPT Editorial Panel created three new codes
to describe allografts. These codes were designated as add-on codes and
revised to more accurately describe the structural allograft procedures
they represent. For CY 2019, we proposed the RUC-recommended work RVUs
for all three codes. We proposed a work RVU of 13.01 for CPT code 20932
(Allograft, includes templating, cutting, placement and internal
fixation when performed; osteoarticular, including articular surface
and contiguous bone), a work RVU of 11.94 for CPT code 20933
(Allograft, includes templating, cutting, placement and internal
fixation when performed; hemicortical intercalary, partial (i.e.,
hemicylindrical)), and a work RVU of 13.00 for CPT code 20934
(Allograft, includes templating, cutting, placement and internal
fixation when performed; intercalary, complete (i.e., cylindrical)).
These three new codes are all facility-only procedures with no
recommended direct PE inputs.
We did not receive any comments on our proposals involving the
Structural Allograft family of codes. Therefore we are finalizing the
work RVUs for the codes in this family as proposed.
(6) Knee Arthrography Injection (CPT Code 27369)
CPT code 27370 (Injection of contrast for knee arthrography)
repeatedly appeared on high volume growth screens between 2008 and
2016, and the RUC expressed concern that the high volume growth for
this procedure was likely due to its being reported incorrectly as
arthrocentesis or aspiration. In June 2017, the CPT Editorial Panel
deleted CPT code 27370 and replaced it with a new code, 27369, to
report injection procedure for knee arthrography or enhanced CT/MRI
knee arthrography.
The RUC recommended a work RVU of 0.96 for CPT code 27369, which is
identical to the work RVU for CPT code 27370 (Injection of contrast for
knee arthrography). The RUC's recommendation is based on key reference
service, CPT code 23350 (Injection procedure for shoulder arthrography
or enhanced CT/MRI shoulder arthrography), with identical intraservice
time (15 minutes) and total time (28 minutes) as the new CPT code and a
work RVU of 1.00. The RUC notes that its recommendation is lower than
the 25th percentile from the survey results, but that the work
described by the service should be valued identically with the CPT code
being replaced. We disagreed with the RUC's recommended work RVU for
CPT code 27369. Both the total (28 minutes) and intraservice (15
minutes) times for the new CPT code are considerably lower than the
deleted CPT code 27370. Based on the reduced times and the projected
work RVU from the reverse building block methodology (0.60 work RVUs),
we believe this CPT code should be valued at 0.77 work RVUs, supported
by a crosswalk to CPT code 29075 (Application, cast; elbow to finger
(short arm)), with total time of 27 minutes and intraservice time of 15
minutes. Therefore, we proposed a work RVU of 0.77 for CPT code 27369.
For the direct PE inputs, we proposed to refine the clinical labor
time for the ``Prepare room, equipment and supplies'' (CA013) activity
to 3 minutes and to refine the clinical labor time for the ``Confirm
order, protocol exam'' (CA014) activity to 0 minutes. The predecessor
code for 27369, CPT code 27370, did not have clinical labor time
assigned for the ``Confirm order, protocol exam'' clinical labor task,
and we do not have any reason to believe that the services being
furnished by the clinical staff have changed, only the way in which
this clinical labor time has been presented on the PE worksheets. We
also noted that there is no effect on the total clinical labor direct
costs in these situations, since the same 3 minutes of clinical labor
time is still being furnished.
We proposed to remove the clinical labor time for the ``Scan exam
documents into PACS. Complete exam in RIS system to populate images
into work queue'' (CA032) activity. CPT code 27369 does not include a
PACS workstation among the recommended equipment, and the predecessor
code 27370 did not previously include time for this clinical labor
activity. We believe that data entry activities such as this task would
be classified as indirect PE, as they are considered administrative
activities and are not individually allocable to a particular patient
for a particular service. We also proposed to refine the equipment
times in accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on
our proposals involving CPT code 27369.
Comment: We received one comment regarding our proposed work RVU
for CPT code 27369 of 0.77 RVUs. The commenter disagreed with CMS's
reference to CPT code 27370, which is being deleted, as a basis for
evaluating whether the RUC's proposed work RVU for this CPT code (0.96)
adequately accounts for the large reduction in time between the deleted
code, CPT code 27370 and the new code, CPT code 27369. The commenter
noted that it is particularly inappropriate for CMS to value codes on
the basis of time differences when the comparison code had not been
previously surveyed by the RUC. The commenter urged CMS to finalize the
RUC-recommended work RVU for CPT code 27369 of 0.96.
Response: We use several parameters to review the work RVU for
codes including, where applicable, refining the work RVUs in direct
proportion to either total time or intraservice time based on the best
available information regarding the time resources involved in
furnishing particular services. We note that the reason the CPT
Editorial Panel was asked to review the code was to prevent incorrect
reporting of the code, not to reflect a fundamentally different
service. The work involved in furnishing the service described by CPT
code 27369 is not fundamentally different from the work involved in
furnishing the service described by the deleted code. In such cases we
do not believe it is inappropriate to compare the survey times for the
new code to the existing time for the code that it is intended to
replace as one of several parameters we consider in our review. We are
finalizing a work RVU for CPT code 27369 of 0.77 as proposed.
Comment: A commenter stated that in the CMS refinements to the
direct PE inputs for CPT code 27369, CMS proposed to remove 1 minute
from the CA014 activity code and proposed to add 1 minute to the CA013
activity code. The commenter stated that this refinement was inaccurate
and encouraged CMS to modify this proposal by finalizing the RUC-

[[Page 59526]]

recommended direct PE inputs for clinical labor.
Response: We addressed this subject in detail in the PE section of
this final rule under the Changes to Direct PE Inputs for Specific
Services heading (section II.B.3. of this final rule). For CPT code
27369, we are finalizing these clinical labor refinements as proposed.
Comment: One commenter agreed with the proposed CMS refinement to
the CA032 clinical labor activity.
Response: We appreciate the support for our proposal from the
commenter.
After consideration of the public comments, we are finalizing the
direct PE inputs for CPT code 27369 as proposed.
(7) Application of Long Arm Splint (CPT Code 29105)
CPT code 29105 (Application of long arm splint (shoulder to hand))
was identified as potentially misvalued on a screen of 0-day global
services reported with an E/M visit 50 percent of the time or more, on
the same day of service by the same patient and the same practitioner,
that have not been reviewed in the last 5 years with Medicare
utilization greater than 20,000. For CY 2019, we proposed the RUC-
recommended work RVU of 0.80 for CPT code 29105. For the direct PE
inputs, we proposed to refine the equipment times in accordance with
our standard equipment time formulas.
The following is a summary of the public comments we received on
our proposals involving CPT code 29105.
Comment: Some commenters expressed support for our proposal to
accept the RUC-recommended work RVU for this code.
Response: We appreciate the support for our proposal from the
commenters.
Comment: One commenter stated that CMS did not indicate what amount
of service period time was removed from the calculation of the
equipment time, and that this made it difficult to determine the
accuracy of the refinements. The commenter requested more information
about this change.
Response: For the five equipment items utilized in CPT code 29105,
we removed the clinical labor for the CA035 clinical labor activity
code in accordance with our standard equipment time formula for non-
highly technical equipment.
After consideration of the public comments, we are finalizing the
work RVU and direct PE inputs for CPT code 29105 as proposed.
(8) Strapping Lower Extremity (CPT Codes 29540 and 29550)
CPT codes 29540 (Strapping; ankle and/or foot) and 29550
(Strapping; toes) were identified as potentially misvalued on a screen
of 0-day global services reported with an E/M visit 50 percent of the
time or more, on the same day of service by the same patient and the
same practitioner, that have not been reviewed in the last 5 years with
Medicare utilization greater than 20,000. For CY 2019, we proposed the
HCPAC-recommended work RVU of 0.39 for CPT code 29540 and the HCPAC-
recommended work RVU of 0.25 for CPT code 29550.
For the direct PE inputs, we proposed to refine the clinical labor
time for the ``Provide education/obtain consent'' (CA011) activity from
3 minutes to 2 minutes for both codes, as this is the standard clinical
labor time assigned for patient education and consent. We also proposed
to remove the 2 minutes of clinical labor time for the ``Review home
care instructions, coordinate visits/prescriptions'' (CA035) activity
for both codes. CPT codes 29540 and 29550 are both typically billed
with a same day E/M service, and we believe that it would be
duplicative to assign clinical labor time for reviewing home care
instructions given that this task would typically be done during the
same day E/M service. We also proposed to refine the equipment times in
accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on
our proposals involving the Strapping Lower Extremity family of codes.
Comment: A few commenters supported our proposal to accept the
HCPAC-recommended work RVUs.
Response: We appreciate the support for our proposal from the
commenters.
Comment: Several commenters disagreed with the proposed direct PE
refinements to CPT codes 29540 and 29550. Commenters stated that CMS
mistakenly cited a standard for this activity of 2 minutes, however
there is no set standard for CA011, and that 3 minutes is needed for
clinical staff to perform this clinical activity.
Response: We disagree with the commenters that 3 minutes would be
typically needed for the clinical staff to provide education and obtain
consent in these procedures. We have typically assigned 2 minutes for
this clinical labor activity unless we had a specific rationale for a
higher amount of clinical labor time, and we continue to believe that
this standard amount of clinical labor time would be the most accurate
value for CPT codes 29540 and 29550.
Comment: Several commenters disagreed that the clinical labor for
home care instructions and coordinating visits/prescriptions would be
duplicative with the same day E/M office visit in these services.
Commenters stated that these home care instructions directly pertain to
the strapping procedure and would not be provided during an evaluation
of the patient. Commenters stated that the strappings do not work
unless left alone and taken care of in a specific manner, and that this
important information is included in the home care instructions that
the patient receives from clinical staff.
Response: We disagree with the commenters and we continue to
believe that this clinical labor would be duplicative with the same day
E/M visit. We believe that this clinical labor would take place during
the same day E/M visit. Due to the way patients typically present in
these procedures, we do not believe that the patients would typically
need additional home care instructions above and beyond the E/M visit.
We also note that these strapping procedures are frequently repeated
for the same patient multiple times, and there would not be a need for
repeated home care instructions for subsequent strapping procedures for
the same patient. Any home care instructions taking place outside of
the same day E/M visit would only be needed the first time that these
procedures are performed on a patient, and as a result they would not
be typical. As a result, we continue to believe that this clinical
labor would not be typical.
Comment: One commenter stated that CMS did not indicate what amount
of service period time was removed from the calculation of the
equipment time, and that this made it difficult to determine the
accuracy of the refinements. The commenter requested more information
about this change.
Response: For the two equipment items utilized in these CPT codes,
we removed the clinical labor for the CA035 clinical labor activity
code in accordance with our standard equipment time formula for non-
highly technical equipment.
After consideration of the public comments, we are finalizing the
work RVU and direct PE inputs for CPT codes 29540 and 29550 as
proposed.
(9) Bronchoscopy (CPT Codes 31623 and 31624)
CPT code 31623 (Bronchoscopy, rigid or flexible, including
fluoroscopic guidance, when performed; with

[[Page 59527]]

brushing or protected brushings) was identified on a high growth screen
of services with total Medicare utilization of 10,000 or more that have
increased by at least 100 percent from 2009 through 2014. CPT code
31624 (Bronchoscopy, rigid or flexible, including fluoroscopic
guidance, when performed; with bronchial alveolar lavage) was also
included for review as part of the same family of codes. For CY 2019,
we proposed the RUC-recommended work RVU of 2.63 for CPT codes 31623
and 31624.
For the direct PE inputs, we proposed to refine the clinical labor
time for the ``Complete post-procedure diagnostic forms, lab and x-ray
requisitions'' (CA027) activity from 4 minutes to 2 minutes for CPT
codes 31623 and 31624. Two minutes is the standard time, as well as the
current time for this clinical labor activity, and we have no reason to
believe that the time to perform this task has increased since the
codes were last reviewed. We did not receive any explanation in the
recommendations as to why the time for this activity would be doubling
over the current values. We also proposed to refine the equipment times
in accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on
our proposals involving the Bronchoscopy family of codes.
Comment: Several commenters disagreed with the proposal to refine
the clinical labor time for the ``Complete post-procedure diagnostic
forms, lab and x-ray requisitions'' (CA027) activity from 4 minutes to
2 minutes for CPT codes 31623 and 31624. Commenters stated that there
is no standard for the CA027 clinical labor activity and that the CMS
logic to conform to such a standard lacks merit. Commenters also stated
that these services require verification of samples, and completion of
several lab forms and clearly requires more than the standard time for
completing forms.
Response: We disagree with the commenters. While it is true that we
have not formalized 2 minutes as a standard through rulemaking for this
clinical labor activity code, we have typically assigned 2 minutes for
the CA027 activity across a wide variety of codes. Out of the 168 HCPCS
codes that have clinical labor time for the CA027 clinical labor
activity in our database, 64 codes have 2 minutes of assigned clinical
labor time while only 9 codes have 4 minutes of assigned clinical labor
time, which indicates that 2 minutes is far more typical for this
activity. More importantly, commenters did not address our statement
that 2 minutes is the current time for this clinical labor activity,
and we had no reason to believe that the time to perform this task has
increased since the codes were last reviewed. As a result, we are
finalizing our refinement to 2 minutes of clinical labor time for the
CA027 activity.
After consideration of the public comments, we are finalizing the
work RVU and direct PE inputs for CPT codes 31623 and 31624 as
proposed.
(10) Pulmonary Wireless Pressure Sensor Services (CPT Codes 33289 and
93264)
In September 2017, the CPT Editorial Panel created a code to
describe pulmonary wireless sensor implantation and another code for
remote care management of patients with an implantable, wireless
pulmonary artery pressure sensor monitor. For CY 2019, we proposed the
RUC-recommended work RVU of 6.00 for CPT code 33289 (Transcatheter
implantation of wireless pulmonary artery pressure sensor for long term
hemodynamic monitoring, including deployment and calibration of the
sensor, right heart catheterization, selective pulmonary
catheterization, radiological supervision and interpretation, and
pulmonary artery angiography, when performed), and the RUC-recommended
work RVU of 0.70 for CPT code 93264 (Remote monitoring of a wireless
pulmonary artery pressure sensor for up to 30 days including at least
weekly downloads of pulmonary artery pressure recordings,
interpretation(s), trend analysis, and report(s) by a physician or
other qualified health care professional).
We did not propose any direct PE refinements for this code family.
The following is a summary of the public comments we received on
our proposals involving the Pulmonary Wireless Pressure Sensor Services
family of codes.
Comment: Commenters were supportive of our proposal of the RUC-
recommended work RVUs.
Response: We thank commenters for their support.
After consideration of the public comments, we are finalizing the
RUC-recommended work RVUs for CPT codes 33289 and 93264 as proposed.
(11) Cardiac Event Recorder Procedures (CPT Codes 33285 and 33286)
In February 2017, the CPT Editorial Panel created two new codes
replacing cardiac event recorder codes to reflect new technology. For
CY 2019, we proposed the RUC-recommended work RVU of 1.53 for CPT code
33285 (Insertion, subcutaneous cardiac rhythm monitor, including
programming) and the RUC-recommended work RVU of 1.50 for CPT code
33286 (Removal, subcutaneous cardiac rhythm monitor).
We did not propose any direct PE refinements for this code family.
The following is a summary of the public comments we received on
our proposals involving the Cardiac Event Recorder Procedures family of
codes.
Comment: Commenters were supportive of our proposal of the RUC-
recommended work RVUs.
Response: We thank commenters for their support.
After consideration of the public comments, we are finalizing the
RUC-recommended work RVUs and direct PE inputs for CPT codes 33285 and
33286 as proposed.
(12) Aortoventriculoplasty With Pulmonary Autograft (CPT Code 33440)
In September 2017, the CPT Editorial Panel created one new code to
combine the efforts of aortic valve and root replacement with
subvalvular left ventricular outflow tract enlargement to allow for an
unobstructed left ventricular outflow tract.
For CY 2019, we proposed the RUC-recommended work RVU of 64.00 for
CPT code 33440 (Replacement, aortic valve; by translocation of
autologous pulmonary valve and transventricular aortic annulus
enlargement of the left ventricular outflow tract with valved conduit
replacement of pulmonary valve (Ross-Konno procedure)). When this code
is re-reviewed in a few years as part of the new technology screen, we
look forward to receiving new recommendations on the whole family,
including the related Ross and Konno procedures (CPT codes 33413 and
33412 respectively) that were used as references for CPT code 33440.
For the direct PE inputs, we proposed to refine the preservice
clinical labor times to match our standards for 90-day global
procedures. We proposed to refine the clinical labor time for the
``Coordinate pre-surgery services (including test results)'' (CA002)
activity from 25 minutes to 20 minutes, to refine the clinical labor
time for the ``Schedule space and equipment in facility'' (CA003)
activity from 12 minutes to 8 minutes, and to refine the clinical labor
time for the ``Provide pre-service education/obtain consent'' (CA004)
activity from 26 minutes to 20 minutes. We also proposed to add 15
minutes of clinical labor time for the ``Perform regulatory mandated
quality assurance activity (pre-service)'' (CA008) activity. We agreed
with the recommendation that the total preservice clinical labor

[[Page 59528]]

time for CPT code 33440 is unchanged from the two reference codes at 75
minutes. However, we believed that the clinical labor associated with
additional coordination between multiple specialties prior to patient
arrival is more accurately described through the use of the CA008
activity code than by distributing this 15 minutes amongst the other
preservice clinical labor activities. We previously established
standard preservice times for 90-day global procedures, and did not
want to propose clinical labor times above those standards for CPT code
33440. We also noted that there is no effect on the total clinical
labor direct costs in this situation, since the same 15 minutes of
preservice clinical labor time is still being furnished.
The following is a summary of the public comments we received on
our proposals involving CPT code 33440.
Comment: A few commenters stated that they had no objections to the
CMS proposal to refine the preservice clinical labor times for the
direct PE inputs for code 33440 to match the 90-day global procedure
standards and to add 15 minutes of clinical labor time to clinical
labor activity code CA008. The commenters stated that they believed the
RUC-recommended allocation of the preservice activities was
appropriate, whereas activity code CA008 was not an accurate
description of the additional work being done, and hoped that CMS would
not use the allocation of time to CA008 as a way to reduce the
preservice time in future rulemaking.
Response: We appreciate the feedback on our proposed direct PE
refinements from the commenters.
After consideration of the public comments, we are finalizing the
work RVUs and direct PE inputs for CPT code 33440 as proposed.
(13) Hemi-Aortic Arch Replacement (CPT Code 33866)
At the September 2017 CPT Editorial Panel meeting, the Panel
created one new add-on code to report hemi-aortic arch graft
replacement. For CY 2019, we proposed the RUC-recommended work RVU of
19.74 for CPT code 33866 (Aortic hemiarch graft including isolation and
control of the arch vessels, beveled open distal aortic anastomosis
extending under one or more of the arch vessels, and total circulatory
arrest or isolated cerebral perfusion). CPT code 33866 is a facility-
only procedure with no recommended direct PE inputs.
The following is a summary of the public comments we received on
our proposals involving CPT code 33866.
Comment: We received several comments, including comments from the
RUC. The RUC noted in its comment letter that at the April 2018 RUC
meeting, the specialty societies determined that the family of services
encompassing CPT code 33866 should be submitted to the CPT Editorial
Panel for the following revisions: (1) To develop distinct codes for
ascending aortic report for dissection and ascending aortic repair for
other ascending aortic disease such as aneurysms and congenital
anomalies. The specialties noted that there is a difference in the work
associated with these procedures and now there is sufficient volume to
allow for more accurate capture of the work and outcomes data for these
distinct patient populations, which was not the case when the code was
first developed, (2) Revise the descriptor for transverse arch code,
CPT code 33870, to further clarify the difference in work between the
new add on code, CPT code 33866, and (3) Revise the guidelines to
provide additional instructions on the appropriate use of these codes.
The RUC further noted that the specialty societies had already
submitted a new coding proposal for consideration at the May 2018 CPT
Editorial Panel for CPT 2020, which the RUC supported. Following the
April 2018 RUC meeting, the RUC rescinded its interim value
recommendation (work RVU of 19.74) to us for CPT code 33866 for CY
2019. One commenter noted, that although the RUC rescinded the interim
work RVU of 19.74 due to a specialty societies' recommendation to
submit the family of services to the CPT Editorial Panel, they
encouraged CMS to consider using the work RVU of 19.74 as an interim
value until the code can be re-surveyed and reviewed by the RUC. The
commenter further noted that using the RUC-recommended value would
allow physicians to be paid for the service in CY 2019, decreasing the
burden of reporting a carrier-priced service to both the carriers and
providers.
Response: While we recognize that the RUC rescinded its work RVU
recommendation, we note that we proposed the RUC-recommended work RVU
for valuation in CY 2019. We also want to remind commenters that we no
longer establish interim valuations on a routine basis, and we are not
convinced that establishing an interim valuation for CPT code 33866 is
necessary. We will review any new coding that the CPT Editorial Panel
provides for 2020, and will review any recommendations we receive
timely from the RUC or other stakeholders for valuation through CY 2020
rulemaking.
After consideration of the public comments received, we are
finalizing the RUC-recommended work RVUs for CPT code 33866 as
proposed.
(14) Leadless Pacemaker Procedures (CPT Codes 33274 and 33275)
At the September 2017 CPT Editorial Panel meeting, the Panel
replaced the five leadless pacemaker services, Category III codes, with
the addition of two new CPT codes to report transcatheter leadless
pacemaker procedures and revised five codes to include evaluation and
interrogation services of leadless pacemaker systems.
For CPT code 33274 (Transcatheter insertion or replacement of
permanent leadless pacemaker, right ventricular, including imaging
guidance (e.g., fluoroscopy, venous ultrasound, ventriculography,
femoral venography) and device evaluation (e.g., interrogation or
programming), when performed), we disagreed with the recommended work
RVU of 8.77 and we proposed a work RVU of 7.80 based on a direct
crosswalk to one of the top reference codes selected by the RUC survey
participants, CPT code 33207 (Insertion of new or replacement of
permanent pacemaker with transvenous electrode(s); ventricular). This
code has the same 60 minutes of intraservice time as CPT code 33274 and
an additional 61 minutes of total time at a work RVU of 7.80. In our
review of CPT code 33274, we noted that this reference code had an
additional inpatient hospital visit of CPT code 99232 (Subsequent
hospital care, per day, for the evaluation and management of a patient,
which requires at least 2 of 3 key components) and a full instead of a
half discharge visit of CPT code 99238 (Hospital discharge day
management; 30 minutes or less) included in its 90-day global period.
The combined work RVU of these two visits would be equal to 2.03.
However, the recommended work RVU for CPT code 33274 was 0.97 work RVUs
higher than CPT code 33207, despite having fewer of these visits and
significantly less surveyed total time. While we acknowledge that CPT
code 33274 is a more intense procedure than CPT code 33207, we do not
believe that it should be valued almost a full RVU higher than the
reference code given the fewer visits in the global period and the
lower surveyed work time.
Therefore, we proposed to crosswalk CPT code 33274 to CPT code
33207 at the same work RVU of 7.80. The proposed work RVU was also
supported through a reference crosswalk to CPT code 38542 (Dissection,
deep jugular node(s)), which has 60 minutes of intraservice time, 198
minutes of total time, and a work RVU of 7.95. We believe that our
proposed work RVU of

[[Page 59529]]

7.80 is a more accurate valuation for CPT code 33274, while still
recognizing the greater intensity of this procedure in comparison to
its reference code.
For CPT code 33275 (Transcatheter removal of permanent leadless
pacemaker, right ventricular), we disagreed with the RUC-recommended
work RVU of 9.56 and we proposed a work RVU of 8.59. Although we
disagreed with the RUC-recommended work RVU, we concurred that the
relative difference in work between CPT codes 33274 and 33275 is
equivalent to the recommended interval of 0.79 RVUs. Therefore, we
proposed a work RVU of 8.59 for CPT code 33275, based on the
recommended interval of 0.79 additional RVUs above our proposed work
RVU of 7.80 for CPT code 33274. We also noted that our proposed work
RVU for CPT code 33275 situates it approximately halfway between the
two reference codes from the survey, with CPT code 33270 (Insertion or
replacement of permanent subcutaneous implantable defibrillator system,
with subcutaneous electrode, including defibrillation threshold
evaluation, induction of arrhythmia, evaluation of sensing for
arrhythmia termination, and programming or reprogramming of sensing or
therapeutic parameters, when performed) having an intraservice time of
90 minutes and a work RVU of 9.10, and CPT code 33207 having an
intraservice time of 60 minutes and a work RVU of 7.80. CPT code 33275
has a surveyed intraservice time of 75 minutes and nearly splits the
difference between them at our proposed work RVU of 8.59.
We did not propose any direct PE refinements for this code family.
The following is a summary of the public comments we received on
our proposals involving the Leadless Pacemaker Procedures family of
codes.
Comment: One commenter recommended that CMS adopt the RUC-
recommended RVUs for both codes due to the newness of the procedures.
The commenter stated that there might not be sufficient evidence or
rationale for CMS to disagree with the RUC-recommended values, and
again cited the newness of these procedures.
Response: We disagree with the commenter that the newness of a
procedure would provide a sufficient rationale for finalizing the RUC-
recommended work RVU for a new CPT code without any further
consideration. Establishing valuations for newly created CPT codes is a
routine part of maintaining the PFS, and we have historically valued
new services since the inception of the resource-based relative value
system. We also believe that RUC surveys are less likely to be
representative of practitioners when evaluating new services, due to
the fact that practitioners are not yet sufficiently experienced with
the services to provide accurate evaluations, which is why we have been
supportive of the RUC's policy to resurvey new services a few years
after their creation when typical practice patterns have been more
firmly established.
Comment: Many commenters disagreed with the proposed work RVUs for
CPT codes 33274 and 33275 and stated that CMS should instead finalize
the RUC-recommended work RVUs for these services. Commenters stated
that CMS provided no qualitative or quantitative rationale to support
their assumption that the difference in time between CPT codes 33274
and the top key reference from the survey (CPT code 33207) completely
reflects the difference in intensity. Commenters stated that patients
receiving leadless pacemakers are more complex and have more
comorbidities and contraindications than transvenous patients, with
more significant groin complications and more commonly present
tamponade. Commenters stated that there were other issues that make CPT
code 33274 more challenging, including: (1) Capture thresholds tend to
change more than with transvenous devices; (2) There is a higher risk
for complications including embolization and groin complications, which
are not associated with tranvenous implants; and (3) Patients
undergoing leadless pacemaker procedures are more likely to have
chronic atrial fibrillation and poor venous access. Commenters
emphasized that they believed the leadless pacemaker procedure
described by CPT code 33274 was more intensive than the CMS crosswalk
to CPT code 33207.
Response: We disagree with the commenters' assertion that we
provided no qualitative or quantitative rationale to support our choice
of a crosswalk to CPT code 33207. We stated in the proposed rule that
in our review of CPT code 33274, we noted that this reference code had
an additional inpatient hospital visit of CPT code 99232 and a full,
instead of a half, discharge visit of CPT code 99238 included in its
90-day global period. We acknowledged that CPT code 33274 is a more
intense procedure than CPT code 33207; however, we did not believe that
it should be valued almost a full RVU higher than the reference code.
We also supported the proposed work RVU through the use of a reference
code, CPT code 38542, which was not addressed by the commenters.
We also disagree with the commenters that CPT code 33274 has so
much additional intensity and complexity as compared to key reference
CPT code 33207 that they should be valued at the same work RVU of 8.77.
We note that the RUC's research panel selected preservice package 3,
``a straightforward patient and a difficult procedure'' for CPT code
33274. We believe this indicates that the patient population for CPT
code 33274 would not be unusually difficult or complex as suggested by
the commenters. We further note that the summary of recommendations for
CPT code 33274 states that these patients are typically sent home from
the facility the next day. In contrast, reference CPT code 33207
includes a full hospital inpatient day of post procedure care
associated with CPT code 99322, as well as a full discharge visit
instead of half of a discharge visit. We believe that this further
suggests that the patient population for CPT code 33274 would not be
more difficult or complex than the patient population for CPT code
33207. As we stated in the proposed rule, we continue to acknowledge
that CPT code 33274 is a more intense procedure than CPT code 33207,
but we do not believe that it should be valued almost a full RVU higher
than the reference code given the fewer visits in the global period and
the lower surveyed work time.
Comment: Commenters stated that CMS should use valid methods of
evaluating services, such as survey data and magnitude estimation,
instead of relying on an incremental difference in work RVUs between
CPT codes 33274 and 33275.
Response: We believe the use of an incremental difference between
codes is a valid methodology for setting values, especially in valuing
services within a family of revised codes where it is important to
maintain appropriate intra-family relativity. Historically, we have
frequently utilized an incremental methodology in which we value a code
based upon its incremental difference between another code or another
family of codes. We note that the RUC has also used the same
incremental methodology on occasion when it was unable to produce valid
survey data for a service. We further note that we did not rely solely
on an increment for our proposed work RVU for CPT code 33275,
supporting our proposed valuation by noting that the CMS work RVU of
8.59 situated the code approximately halfway between the two reference
codes from the survey, with CPT code 33270 having an intraservice time
of 90 minutes and a work RVU of 9.10, and CPT code 33207 having an
intraservice

[[Page 59530]]

time of 60 minutes and a work RVU of 7.80.
Comment: Several commenters stated that while these procedures
described in CPT code 33275 will be rare, these patients will still
have the elevated risk factors mentioned in discussion of CPT code
33274 and warranted the additional work indicated by survey respondents
at the 25th percentile of the survey.
Response: We continue to believe that the patients in CPT code
33274 would not be more difficult or complex than the patients in CPT
code 33207 for the reasons detailed above. We continue to believe that
the relative difference in work between CPT codes 33274 and 33275 is
equivalent to the recommended interval of 0.79 RVUs.
After consideration of the public comments, we are finalizing the
work RVUs and direct PE inputs for the codes in the Leadless Pacemaker
Procedures family as proposed.
(15) PICC Line Procedures (CPT Codes 36568, 36569, 36572, 36573, and
36584)
In CY 2016, CPT code 36569 (Insertion of peripherally inserted
central venous catheter (PICC), without subcutaneous port or pump,
without imaging guidance; age 5 years or older) was identified as
potentially misvalued using a high expenditure services screen across
specialties with Medicare allowed charges of $10 million or more. CPT
code 36569 is typically reported with CPT codes 76937 (Ultrasound
guidance for vascular access requiring ultrasound evaluation of
potential access sites, documentation of selected vessel patency,
concurrent real-time ultrasound visualization of vascular needle entry,
with permanent recording and reporting) and 77001 (Fluoroscopic
guidance for central venous access device placement, replacement
(catheter only or complete), or removal) and was referred to the CPT
Editorial Panel to have the two common imaging codes bundled into the
code. In September 2017, the CPT Editorial Panel revised CPT codes
36568 (Insertion of peripherally inserted central venous catheter
(PICC), without subcutaneous port or pump; younger than 5 years of
age), 36569 and 36584 (Replacement, complete, of a peripherally
inserted central venous catheter (PICC), without subcutaneous port or
pump, through same venous access, including all imaging guidance, image
documentation, and all associated radiological supervision and
interpretation required to perform the replacement) and created two new
CPT codes to specify the insertion of peripherally inserted central
venous catheter (PICC), without subcutaneous port or pump, including
all imaging guidance, image documentation, and all associated
radiological supervision and interpretation required to perform the
insertion.
For CY 2019, we proposed the RUC-recommended work RVU for two of
the CPT codes in the family. We proposed the RUC-recommended work RVU
of 2.11 for CPT code 36568 and the RUC-recommended work RVU of 1.90 for
CPT code 36569.
For CPT code 36572 (Insertion of peripherally inserted central
venous catheter (PICC), without subcutaneous port or pump, including
all imaging guidance, image documentation, and all associated
radiological supervision and interpretation required to perform the
insertion; younger than 5 years of age), we disagreed with the RUC-
recommended work RVU of 2.00 and proposed a work RVU of 1.82 based on a
direct crosswalk to CPT code 50435 (Exchange nephrostomy catheter,
percutaneous, including diagnostic nephrostogram and/or ureterogram
when performed, imaging guidance (e.g., ultrasound and/or fluoroscopy)
and all associated radiological supervision and interpretation). CPT
code 50435 is a recently reviewed code that also includes radiological
supervision and interpretation with similar intraservice and total time
values. In our review of CPT code 36572, we were concerned about the
possibility that the recommended work RVU of 2.00 could create a rank
order anomaly in terms of intensity with the other codes in the family.
We noted that the recommended intraservice time for CPT code 36572 as
compared to CPT code 36568, the most similar code in the family, is
decreasing from 38 minutes to 22 minutes (42 percent), and the
recommended total time is decreasing from 71 minutes to 51 minutes (38
percent); however, the recommended work RVU is only decreasing from
2.11 to 2.00, which is a reduction of just over 5 percent. We also
noted that CPT code 36572 has a lower recommended intraservice time and
total time as compared to CPT code 36569, yet has a higher recommended
work RVU. Although we did not imply that the decreases in time as
reflected in survey values must equate to a one-to-one or linear
decrease in the valuation of work RVUs, we believe that since the two
components of work are time and intensity, significant decreases in
time should be reflected in decreases to work RVUs.
In the case of CPT code 36572, we believed that it would be more
accurate to propose a work RVU of 1.82 based on a crosswalk to CPT code
50435 to better fit with the recommended work RVUs for CPT codes 36568
and 36569. The proposed work valuation was also based on the use of
three additional crosswalk codes: CPT code 32554 (Thoracentesis, needle
or catheter, aspiration of the pleural space; without imaging
guidance), CPT code 43198 (Esophagoscopy, flexible, transnasal; with
biopsy, single or multiple), and CPT code 64644 (Chemodenervation of
one extremity; 5 or more muscles). All of these codes were recently
reviewed with similar intensity, intraservice time, and total time
values, and all three of them share a work RVU of 1.82.
For CPT code 36573 (Insertion of peripherally inserted central
venous catheter (PICC), without subcutaneous port or pump, including
all imaging guidance, image documentation, and all associated
radiological supervision and interpretation required to perform the
insertion; age 5 years or older), we disagreed with the RUC-recommended
work RVU of 1.90 and proposed a work RVU of 1.70 based on maintaining
the current work RVU of CPT code 36569. In our review of CPT code
36573, we were again concerned about the possibility that the
recommended work RVU of 1.90 could create a rank order anomaly in terms
of intensity with the other codes in the family. We noted that the
recommended intraservice time for CPT code 36573 as compared to CPT
code 36569, the most similar code in the family, was decreasing from 27
minutes to 15 minutes (45 percent), and the recommended total time was
decreasing from 60 minutes to 40 minutes (33 percent); however, the
RUC-recommended work RVU was exactly the same for these two codes at
1.90. Although we did not imply that the decreases in time as reflected
in survey values must equate to a one-to-one or linear decrease in the
valuation of work RVUs, we believe that since the two components of
work are time and intensity, significant decreases in time should be
reflected in decreases to work RVUs.
In the case of CPT code 36573, we believed that it would be more
accurate to propose a work RVU of 1.70 based on maintaining the current
work RVU of CPT code 36569. These two CPT codes describe the same
procedure done with (CPT code 36573) and without (CPT code 35659)
imaging guidance and radiological supervision and interpretation.
Because the inclusion of the imaging described by CPT code 36573 has
now become the typical case for this service, we believe that it is
more accurate to maintain the current work RVU of 1.70 as opposed to

[[Page 59531]]

increasing the work RVU to 1.90, especially considering that the new
surveyed work time for CPT code 36573 is lower than the current work
time for CPT code 36569. The proposed work RVU of 1.70 was also based
on a crosswalk to CPT code 36556 (Insertion of non-tunneled centrally
inserted central venous catheter; age 5 years or older). This is a
recently reviewed code with the same 15 minutes of intraservice time
and the same 40 minutes of total time with a work RVU of 1.75.
For CPT code 36584, we disagreed with the RUC-recommended work RVU
of 1.47 and proposed a work RVU of 1.20 based on maintaining the
current work RVU. We noted that the recommended intraservice time for
CPT code 36584 was decreasing from 15 minutes to 12 minutes (20 percent
reduction), and the recommended total time was decreasing from 45
minutes to 34 minutes (25 percent reduction); however, the recommended
work RVU was increasing from 1.20 to 1.47, an increase of approximately
23 percent. Although we did not imply that the decreases in time as
reflected in survey values must equate to a one-to-one or linear
decrease in the valuation of work RVUs, we believed that since the two
components of work are time and intensity, significant decreases in
time should be reflected in decreases to work RVUs. We were especially
concerned when the recommended work RVU is increasing despite survey
results indicating that the work time is decreasing due to a
combination of improving technology and greater efficiencies in
practice patterns.
In the case of CPT code 36584, we believed that it would be more
accurate to propose a work RVU of 1.20 based on maintaining the current
work RVU for the code. Because the inclusion of the imaging has now
become the typical case for this service, we believed that it was more
accurate to maintain the current work RVU of 1.20 as opposed to
increasing the work RVU to 1.47, especially considering that the new
surveyed work time for CPT code 36584 was decreasing from the current
work time. The proposed work RVU of 1.20 was also based on a crosswalk
to CPT code 40490 (Biopsy of lip), which has the same total time of 34
minutes and slightly higher intraservice time at a work RVU of 1.22.
We noted that the RUC-recommended work pool was increasing by
approximately 68 percent for the PICC Line Procedures family as a
whole, while the RUC-recommended work time pool for the same codes was
only increasing by about 22 percent. Since time is defined as one of
the two components of work, we believe that this indicated a
discrepancy in the recommended work values. We do not believe that the
recoding of the services in this family has resulted in an increase in
their intensity, only a change in the way in which they will be
reported, and therefore, we did not believe that it would serve the
interests of relativity to propose the RUC-recommended work values for
all of the codes in this family. We believe that, generally speaking,
the recoding of a family of services should maintain the same total
work pool, as the services themselves are not changing, only the coding
structure under which they are being reported. We also noted that,
through the bundling of some of these frequently reported services, it
is reasonable to expect that the new coding system will achieve savings
via elimination of duplicative assumptions of the resources involved in
furnishing particular servicers. For example, a practitioner would not
be carrying out the full preservice work three times for CPT codes
36568, 76937, and 77001, but preservice times were assigned to all of
the codes under the old coding. We believed the new coding assigns more
accurate work times and thus reflects efficiencies in resource costs
that existed but were not reflected in the services as they were
previously reported.
For the direct PE inputs, we proposed to refine the clinical labor
time for the ``Prepare, set-up and start IV, initial positioning and
monitoring of patient'' (CA016) activity from 4 minutes to 2 minutes
for CPT codes 36572 and 36573. We noted that the two reference codes
for the two new codes, CPT codes 36568 and 36569, currently have 2
minutes assigned for this activity, and CPT code 36584 also has a
recommended 2 minutes assigned to this same activity. We did not agree
that the patient positioning would take twice as long for CPT codes
36572 and 36573 as compared to the rest of the family, and therefore
proposed to refine both of them to the same 2 minutes of clinical labor
time. We also proposed to refine the equipment times in accordance with
our standard equipment time formulas.
The following is a summary of the public comments we received on
our proposals involving the PICC Line Procedures family of codes.
Comment: One commenter stated that CMS believes it is not accurate
to ``increase'' work RVUs when survey results indicate that work time
is ``decreasing'' due to improving technology and greater efficiencies
in practice patterns. The commenter disagreed that the difference
between the current codes (without imaging guidance) and the new
bundled codes (with imaging guidance) could be characterized as an
``increase'' or a ``decrease,'' as it was inappropriate simply to
compare the RVUs of the bundled codes to the existing codes, because
the bundled codes include imaging services that involve significantly
more intense physician work than PICC line insertion without imaging
guidance.
Response: We disagree with the commenter that it is
methodologically inappropriate to characterize changes in surveyed work
time as ``increases'' or ``decreases''. As we stated in the proposed
rule, we do not believe that the revised coding of the services in this
family has changed the services themselves or resulted in an increase
in their intensity, only changed in the way in which they will be
reported under the new coding. CPT code 36572 is a new code resulting
from the bundling together of CPT code 36568 with imaging guidance. The
same services that were previously reported through a combination of
CPT codes 36568 and 76397 will now be reported under CPT code 36572. We
believe that it is highly relevant to note how the recommended work
times for CPT code 36572 compare to the recommended work times for CPT
code 36568, which includes noting that the intraservice time is
decreasing from 38 minutes to 22 minutes (42 percent), and the
recommended total time is decreasing from 71 minutes to 51 minutes (38
percent). We also do not agree that it is inappropriate to compare the
RVUs of the bundled codes to the existing codes, as all of these
procedures describe clinically similar procedures that together
comprise a family of codes. In more general terms, we continue to
believe that the nature of the PFS relative value system is such that
all services are appropriately subject to comparisons to one another.
Although codes with clinically similar services are sometimes stronger
comparator codes, we do not agree that codes must both include imaging
guidance or not include imaging guidance to be used as a crosswalk.
Comment: Several commenters disagreed that the recoding of the
services in the PICC line code family had only resulted in a change in
the way that services will be reported, and stated that that the
imaging-related services now bundled into CPT codes 36572, 36573, and
36584 are significantly more intense than PICC line insertion standing
alone. One commenter stated that valuing a code using imaging guidance
the same or less than the same code without imaging guidance is

[[Page 59532]]

specious and treats the use of imaging guidance as a negative work
component when in fact there is additional work required in using
imaging guidance. Commenters stated that the RUC-recommended values
already reflect efficiencies in radiology work, and that the efficiency
of radiologists should not diminish the RUC's recognition that their
work is significantly more intense in these procedures.
Response: We disagree with the commenters that the addition of
imaging guidance has made CPT codes 36572, 36573, and 36584
significantly more intense than the non-imaging guidance version of
these procedures. While the incorporation of new technology can
sometimes make services more complex and difficult to perform, it can
also have the opposite effect by making services less reliant on manual
skill and technique. We believe that if these procedures were
significantly more intensive to perform, this would be reflected in the
surveyed work times associated with these codes. However, the surveyed
work times are instead decreasing in all three cases in comparison to
the current non-imaging guidance version of the same services. As we
stated in the proposed rule, we believe that the work times for these
services are decreasing due to a combination of improving technology
and greater efficiencies in practice patterns. Based on the RUC-
recommended utilization crosswalk for these services, which has 90 to
95 percent of the utilization expected to be reported under the new
codes that include imaging guidance, we believe that the use of imaging
guidance has become typical for these services and does not represent a
dramatic increase in intensity.
Comment: Many commenters disagreed with the proposed work RVU of
1.82 for CPT code 36572 and stated that CMS should finalize the RUC-
recommended work RVU of 2.00. Commenters stated that the CMS use of a
crosswalk to CPT code 50435 was unsupported on a clinical basis, with
significant differences in work intensity and patient population.
Commenters stated that CPT code 36572 involves establishing new deep
venous access on a pediatric patient while ensuring maximum sterile
barrier technique so as to prevent a hospital acquired infection,
whereas CPT code 50435 involves the exchange of an existing catheter in
an adult who understands the procedure involved and has had previous
catheter exchanges to maintain patency. One commenter stated that the
RUC crosswalk to CPT code 19283 (Placement of breast localization
device(s) (e.g., clip, metallic pellet, wire/needle, radioactive
seeds)) was a more accurate choice because this service also uses
imaging guidance to obtain de novo percutaneous access to a target and
perform an intervention. Commenters stated that the crosswalk code
would frequently be less intense than CPT code 36572.
Response: We disagree with the commenters that the work involved in
CPT code 50435 would be less clinically intense than the work in CPT
code 36572. We believe that the exchange of a nephrostomy catheter
taking place in CPT code 50435 is more difficult than the placement of
a breast localization device as in the RUC crosswalk to CPT code 19283,
percutaneous; first lesion, including stereotactic guidance). We also
disagree with the commenters that the crosswalk we identified lacks
clinical similarity to CPT code 36572. Both the reviewed code and the
crosswalk to CPT code 50435 involve the percutaneous placement of a
catheter in a deep structure; we believe that this crosswalk code is
more clinically similar than the RUC's choice of a crosswalk to CPT
code 19283, which does not involve catheter placement at all.
Commenter: Several commenters disagreed that the RUC-recommended
work RVU of 2.00 for CPT code 36572 would create a rank order anomaly
within the family of codes. Commenters stated that since CPT code 36568
requires more physician time to complete than CPT code 36572 (38 versus
22 minutes intra-service time), the recommended work RVU of 2.00 for
CPT code 36572 maintains the proper rank order within this family of
services considering differences in patient population and differences
in clinical intensity of work.
Response: The commenters did not address the concerns we expressed
regarding a potential rank order anomaly within the family. We noted in
the proposed rule that CPT code 36572 had a lower recommended
intraservice time and total time as compared to CPT code 36569 (not CPT
code 36568), yet had a higher recommended work RVU. We continue to
believe that this creates the potential for a rank order anomaly within
the family, and we do not believe that this discrepancy can be
justified by differences in patient population and differences in
clinical intensity of work.
Comment: Several commenters disagreed with the CMS statement that
the reduced intraservice and total times in CPT code 36572 as compared
to CPT code 36568 should result in a lower work value. Commenters
stated that this was a simplistic comparison based on time, and that
these were two technically different procedures, involving different
patient populations and different service intensity. Commenters stated
that each step in the non-image guided CPT code 36568 takes longer,
though involves more periods of low intensity intraservice work as
compared to CPT code 36572, where each procedural step is performed
sequentially without the less intense intraservice work of the non-
image guided CPT code 36568.
Response: We disagree with the commenters that the reductions in
intraservice and total work time in CPT code 36572 as compared to CPT
code 36568 should not result in a lower work value. Although we do not
imply that the decreases in time as reflected in survey values must
equate to a one-to-one or linear decrease in the valuation of work
RVUs, we continue to believe that, since the two components of work are
time and intensity, significant decreases in time should typically be
reflected in decreases to work RVUs. We disagree that this is a
simplistic comparison, and chose a crosswalk to CPT code 50435 to
better fit with the recommended work RVUs for CPT codes 36568 and
36569.
We also do not agree that CPT codes 36568 and 36572 have
significantly different patient populations and different service
intensity. As we stated in the proposed rule, we do not believe that
the revised coding of the services in this family has changed the
services themselves or resulted in an increase in their intensity, only
changed in the way in which they will be reported under the new coding.
CPT code 36572 is a new code resulting from the bundling together of
CPT code 36568 with imaging guidance. The same services that were
previously reported through a combination of CPT codes 36568 and 76397
will now be reported under CPT code 36572. Given that 90 percent of the
services that were formerly reported using CPT code 36568 will now be
reported using CPT code 36572, we do not agree that these codes
represent significantly different patient populations.
Comment: Many commenters disagreed with the proposed work RVU of
1.70 for CPT code 36573 and stated that CMS should finalize the RUC-
recommended work RVU of 1.90. Commenters stated that CMS should not use
a code value that is no longer in existence as the service (CPT code
36569) itself has been revised and is currently under review in this
family. Commenters stated that the reference was therefore not valid to
the old work RVU.

[[Page 59533]]

Response: We disagree with the commenters that it is somehow
invalid to use a crosswalk to the current work RVU for CPT code 36569.
It is not accurate to state that this code is no longer in existence,
as it is being revised for CY 2019, not deleted. The RUC frequently
recommends maintaining the current work RVU for reviewed codes rather
than using a new work RVU from survey results when it believes that
there is appropriate rationale to do so. Given that CPT code 36573 is a
new code resulting from the bundling together of CPT code 36569 with
imaging guidance, and that the use of imaging guidance has become
typical in the performance of this service, we believe that it is
appropriate to maintain the same work RVU for these services when they
are reported under the new coding, especially in light of the fact that
the surveyed intraservice work time for CPT code 36573 remains the same
15 minutes as the current intraservice work time for CPT code 36569.
Comment: Several commenters stated that CPT code 36573 involves a
different patient population than CPT code 36569, as the patient
population for CPT code 36573 does not have peripheral venous access
present that can be used to obtain central venous access. Commenters
stated that there is no evidence for a rank order anomaly within the
codes in the family considering the differences in intensity and
patient population.
Response: As we stated previously with regard to CPT codes 36568
and 36572, we also do not agree that CPT codes 36569 and 36573 have
significantly different patient populations and different service
intensity. As we stated in the proposed rule, we do not believe that
the revised coding of the services in this family has changed the
services themselves or resulted in an increase in their intensity, only
changed in the way in which they will be reported under the new coding.
CPT code 36573 is a new code resulting from the bundling together of
CPT code 36569 with imaging guidance. The same services that were
previously reported through a combination of CPT codes 36569 and 76397
will now be reported under CPT code 36573. Given that 95 percent of the
services that were formerly reported using CPT code 36569 are expected
to be reported using CPT code 36573, we do not agree that these codes
represent noticeably different patient populations.
Comment: Several commenters disagreed with our use of CPT code
36556 as a reference code. Commenters stated that CPT code 36556
describes line placement in a larger and more central vein such as the
internal jugular vein with known anatomical landmarks and a shorter
distance between access and where the tip terminates centrally while
CPT code 36573 describes access into a smaller vein without anatomic
landmarks. Commenters stated that although imaging is inherent to CPT
code 36573, the catheter is longer and there is a need to navigate the
catheter through these peripheral and central veins for adequate
placement, all of which would require more work.
Response: We disagree with the commenters that CPT code 36556 would
not be an accurate reference code for CPT code 36573. CPT code 36556
describes the insertion of non-tunneled centrally inserted central
venous catheter whereas CPT code 36573 describes the insertion of a
peripherally inserted central venous catheter (PICC). We believe that
these two codes, which both describe the insertion of central venous
catheters, are highly similar to one another on a clinical basis and
also from the perspective of work time, as they share the identical
intraservice work time and total work time. Moreover, after further
consideration, we are not able to identify any other more appropriate
reference code for CPT code 36573 than CPT code 36556.
Comment: Many commenters disagreed with the proposed work RVU of
1.20 for CPT code 36584 and stated that CMS should finalize the RUC-
recommended work RVU of 1.47. Commenters stated that CMS was completely
dismissing the additional work that was bundled in with CPT code 36584
as part of the imaging guidance. Commenters stated that the RUC agreed
that the recommended work RVU of 1.47 involves less time but involves a
significant increase in intensity, and that the work RVU should not
remain at the current work RVU of 1.20 as CPT code 36584 is now a
bundled service.
Response: We disagree with the commenters that the bundling of a
service or the addition of imaging guidance must necessarily increase
the intensity of the service or the work RVU. As we stated above, while
the incorporation of new technology can sometimes make services more
complex and difficult to perform, it can also have the opposite effect
by making services less reliant on manual skill and technique. We
believe that if CPT code 36584 had become significantly more intensive
to perform, this would be reflected in the surveyed work times
associated with the code. However, the surveyed intraservice work time
and total work time for CPT code 36584 are both decreasing from their
current values. As we stated in the proposed rule, we believe that
these work times are decreasing due to a combination of improving
technology and greater efficiencies in practice patterns, and we
believe that the use of imaging guidance has become now typical for CPT
code 36584 and does not represent a dramatic increase in intensity.
Comment: Several commenters disagreed with the proposal to refine
the clinical labor time for the ``Prepare, set-up and start IV, initial
positioning and monitoring of patient'' (CA016) activity from 4 minutes
to 2 minutes for CPT codes 36572 and 36573. Commenters stated that this
additional clinical labor time would be typical since it included
positioning of the patient as well as positioning the two forms of
imaging equipment which are being bundled into the code (fluoroscopy
and ultrasound). Commenters stated that the equipment needs to be
positioned in a manner that is specific to the procedure and the chosen
extremity, and that it takes approximately 2 additional minutes to
position the patient and the equipment for those codes which are
imaging-guided as opposed to those procedures which are not. Commenters
stated that this difference applies to the two new placement codes (CPT
code 36572 and 36573) but not to the replacement code (CPT code 36584)
as the equipment is limited to fluoroscopy and the positioning is
slightly simpler as the site already contains a PICC line.
Response: After consideration of the new information provided by
the commenters regarding the need for additional positioning time, we
are not finalizing our proposed refinement to the CA016 clinical labor
time. Due to this change in clinical labor time, we are also not
finalizing any changes to the RUC-recommended equipment times.
After consideration of the public comments, we are finalizing the
work RVUs for the codes in the PICC Line Procedures family as proposed.
After considering public comments, we are not finalizing our proposed
direct PE refinements, and we are instead finalizing the RUC-
recommended direct PE inputs for all five codes.
(16) Biopsy or Excision of Inguinofemoral Node(s) (CPT Code 38531)
In September 2017, the CPT Editorial Panel created a new code to
describe biopsy or excision of inguinofemoral node(s). A parenthetical
was added to CPT codes 56630 (Vulvectomy, radical, partial) and 56633
(Vulvectomy, radical, complete) to instruct separate reporting of CPT
code 38531 with radical

[[Page 59534]]

vulvectomy. This service was previously reported with unlisted codes.
CPT code 38531 (Biopsy or excision of lymph node(s); open,
inguinofemoral node(s)) is a new CPT code describing a lymph node
biopsy without complete lymphadenectomy. The RUC recommended a work RVU
of 6.74 for CPT code 38531, with 223 minutes of total time and 65
minutes of intraservice time. We proposed the RUC-recommended work RVU
of 6.74 for CPT code 38531. However, we were concerned that this CPT
code is described as having a 10-day global period. The two CPT codes
that are often reported together with this code, CPT codes 56630 and
56633, are both 90-day global codes. In addition, CPT code 38531 has a
discharge visit and two follow up visits in the global period. This is
consistent with the number of postoperative visits typically associated
with 90-day global codes. Therefore, we proposed to assign a 90-day
global indicator for CPT code 38531 rather than the 10-day global time
period reflected in the RUC recommendation.
We did not propose any direct PE refinements for this code family.
Comment: Several commenters thanked us for proposing the RUC-
recommended work RVU of 6.74 for CPT code 38531.
Response: We appreciate the support from commenters.
Comment: Several stakeholders disagreed with CMS's proposal to
change the global status of this code from a 10-day global code to a
90-day global code. They maintained that there are no claims data
available to assess how often CPT code 38531 will be billed together
with CPT codes 56630 or 56633. Commenters also noted that there is no
necessary direct correlation between the two codes (CPT code 56630 and
CPT code 56633) having a 90-day global period and the new code having a
90-day global period.
Response: We agree with commenters that when two or more closely
related CPT codes are billed together, there is no requirement for them
to share the same global period. However, the amount of post service
time and the number of visits in CPT code 38531 are consistent with
other 90-day global codes. We continue to believe that CPT code 38531
should have a 90-day global period and we are finalizing that change as
proposed.
Comment: A few commenters pointed out that CMS has the opportunity
to review the global periods for new codes directly after CPT Editorial
Panel meetings, and that CMS should have provided input regarding the
code's global period at that time.
Response: While some of our staff have the opportunity to review
global periods for new or modified CPT codes immediately after the CPT
Editorial Panel meeting, the Agency does not systematically review or
provide feedback on components of a CPT code, including global period,
until we fully consider and address the code as part of the annual PFS
notice-and-comment rulemaking process.
After consideration of the public comments, we are finalizing a
work RVU of 6.74 for CPT code 38531 as proposed.
(17) Radioactive Tracer (CPT Code 38792)
CPT code 38792 (Injection procedure; radioactive tracer for
identification of sentinel node) was identified as potentially
misvalued on a screen of codes with a negative intraservice work per
unit of time (IWPUT), with 2016 estimated Medicare utilization over
10,000 for RUC reviewed codes and over 1,000 for Harvard valued and
CMS/Other source codes. For CY 2019, we proposed the RUC-recommended
work RVU of 0.65 for CPT code 38792.
For the direct PE inputs, we proposed to refine the clinical labor
time for the ``Prepare room, equipment and supplies'' (CA013) activity
to 3 minutes and to refine the clinical labor time for the ``Confirm
order, protocol exam'' (CA014) activity to 0 minutes. CPT code 38792,
as well as its alternate reference code, CPT code 78300 (Bone and/or
joint imaging; limited area), did not previously have clinical labor
time assigned for the ``Confirm order, protocol exam'' clinical labor
task, and we do not have any reason to believe that the services being
furnished by the clinical staff have changed, only the way in which
this clinical labor time has been presented on the PE worksheets. We
also note that there is no effect on the total clinical labor direct
costs in these situations, since the same 3 minutes of clinical labor
time is still being furnished. We also proposed to refine the equipment
times in accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on
our proposals involving CPT code 38792.
Comment: A commenter stated that they appreciated and supported our
proposal to adopt the RUC-recommended work RVU of 0.65. The commenter
also stated that they agreed with and supported the changes CMS
proposed in clinical labor time and the standardized equipment time
formulas.
Response: We appreciate the support for our proposals from the
commenter.
After consideration of the public comments, we are finalizing the
work RVU and direct PE inputs for CPT code 38792 as proposed.
(18) Percutaneous Change of G-Tube (CPT Code 43760)
CPT code 43760 (Change of gastrostomy tube, percutaneous, without
imaging or endoscopic guidance) was identified as potentially misvalued
on a screen of 0-day global services reported with an E/M visit 50
percent of the time or more, on the same day of service by the same
patient and the same practitioner, that have not been reviewed in the
last 5 years with Medicare utilization greater than 20,000. It was
surveyed for the April 2017 RUC meeting and recommendations for work
and direct PE inputs were submitted to CMS. However, the RUC also noted
that because the data for CPT code 43760 were bimodal, it might be
appropriate to consider changes in the CPT descriptors to better
differentiate physician work. In September 2017, the CPT Editorial
Panel deleted CPT code 43760 and will use two new CPT codes, CPT codes
43762 and 43763, which describe replacement of gastrostomy tube, with
and without revision of gastrostomy tract, respectively. (See
discussion of these codes below.) Therefore, we did not propose work or
direct PE values for CPT code 43760.
Due to the impending deletion of CPT code 43760, we received no
comments on this code.
(19) Gastrostomy Tube Replacement (CPT Codes 43762 and 43763)
In September 2017, the CPT Editorial Panel created two new codes
that describe replacement of gastrostomy tube, with and without
revision of gastrostomy tract, respectively. These two new codes were
surveyed for the January 2018 RUC meeting and recommendations for work
and direct PE inputs were submitted to CMS.
We proposed a work RVU of 0.75 for CPT code 43762 (Replacement of
gastrostomy tube, percutaneous, includes removal, when performed,
without imaging or endoscopic guidance; not requiring revision of
gastrostomy tract.) and a work RVU of 1.41 for CPT code 43763
(Replacement of gastrostomy tube, percutaneous, includes removal, when
performed, without imaging or endoscopic guidance; requiring revision
of gastrostomy tract.), consistent with the RUC's recommendations for
these new CPT codes.

[[Page 59535]]

For the direct PE inputs, we proposed to refine the equipment times
in accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on
our proposals involving the codes in the Gastrostomy Tube Replacement
code family.
Comment: Several commenters stated that they appreciated CMS
proposing the RUC-recommended work RVU for CPT codes 43762 and 43763.
Response: We appreciate the support for our proposals from the
commenters.
Comment: One commenter stated that CMS did not indicate what amount
of service period time was added to the calculation of the equipment
time, and that this made it difficult to determine the accuracy of the
refinements. The commenter requested more information about this
change.
Response: For the four equipment items where we made time
refinements, we added the clinical labor for the CA029 clinical labor
activity in accordance with our standard equipment time formula for
non-highly technical equipment.
After consideration of the public comments, we are finalizing the
work RVU and direct PE inputs for the codes in the as Gastrostomy Tube
Replacement code family as proposed.
(20) Diagnostic Proctosigmoidoscopy--Rigid (CPT Code 45300)
CPT code 45300 (Proctosigmoidoscopy, rigid; diagnostic, with or
without collection of specimen(s) by brushing or washing (separate
procedure)) was identified as potentially misvalued on a screen of 0-
day global services reported with an E/M visit 50 percent of the time
or more, on the same day of service by the same patient and the same
practitioner, that have not been reviewed in the last 5 years, with
Medicare utilization greater than 20,000. For CY 2019, we proposed the
RUC-recommended work RVU of 0.80 for CPT code 45300.
For the direct PE inputs, we proposed to refine the equipment times
in accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on
our proposals involving CPT code 45300.
Comment: Commenters were supportive of our proposal of the RUC-
recommended work RVUs.
Response: We thank commenters for their support.
Comment: One commenter stated that CMS did not indicate what amount
of service period time was removed from the calculation of the
equipment time, and that this made it difficult to determine the
accuracy of the refinements. The commenter requested more information
about this change.
Response: For the four equipment items where we made time
refinements, we removed the clinical labor for the CA035 clinical labor
activity in accordance with our standard equipment time formula for
non-highly technical equipment.
After consideration of the public comments, we are finalizing the
work RVU and direct PE inputs for CPT code 45300 as proposed.
(21) Hemorrhoid Injection (CPT Code 46500)
CPT code 46500 (Injection of sclerosing solution, hemorrhoids) was
identified as potentially misvalued on a screen of codes with a
negative intraservice work per unit of time (IWPUT), with 2016
estimated Medicare utilization over 10,000 for RUC reviewed codes and
over 1,000 for Harvard valued and CMS/Other source codes.
For CPT code 46500, we disagreed with the RUC-recommended work RVU
of 2.00 and we proposed a work RVU of 1.74 based on a direct crosswalk
to CPT code 68811 (Probing of nasolacrimal duct, with or without
irrigation; requiring general anesthesia). This crosswalk code is
another recently-reviewed 10-day global code with the same 10 minutes
of intraservice time and slightly higher total time. When CPT code
46500 was previously reviewed as described in the CY 2016 PFS final
rule with comment period (80 FR 70963), we finalized a proposal to
reduce the work RVU from 1.69 to 1.42, which reduced the work RVU by
the same ratio as the reduction in the total work time. In light of the
additional evidence provided by this new survey, we agree that the work
RVU should be increased from the current value of 1.42. However, we
believe that our proposed work RVU of 1.74 based on a crosswalk to CPT
code 68811 is more accurate than the RUC-recommended work RVU of 2.00.
In the most recent survey of CPT code 46500, the intraservice work
time remained unchanged at 10 minutes while the total time increased by
only 2 minutes, increasing from 59 minutes to 61 minutes (3 percent).
However, the RUC-recommended work RVU is increasing from 1.42 to 2.00,
an increase of 41 percent, and also an increase of 19 percent over the
historic value of 1.69 for CPT code 46500. Although we did not imply
that the increase in time as reflected in survey values must equate to
a one-to-one or linear increase in the valuation of work RVUs, we
believe that since the two components of work are time and intensity,
minimal increases in surveyed work time typically should not be
reflected in disproportionately large increases to work RVUs. In the
case of CPT code 46500, we believe that our crosswalk to CPT code 68811
at a work RVU of 1.74 more accurately maintains relativity with other
10-day global codes on the PFS. We also noted that the 3 percent
increase in surveyed work time for CPT code 46500 matches a 3 percent
increase in the historic work RVU of the code, from 1.69 to 1.74.
Therefore, we proposed a work RVU of 1.74 for CPT code 46500 based on
the aforementioned crosswalk.
For the direct PE inputs, we proposed to remove 10 minutes of
clinical labor time for the ``Assist physician or other qualified
healthcare professional--directly related to physician work time
(100%)'' (CA018) activity. This clinical labor time is listed twice in
the recommendations along with a statement that although the clinical
labor has not changed from prior reviews, time for both clinical staff
members was inadvertently not included in the previous spreadsheets. We
appreciated this notification in the recommendations, and therefore, we
requested more information about why the clinical labor associated with
this additional staff member was left out for previous reviews. We were
particularly interested in knowing what activities the additional staff
member would be undertaking during the procedure. We proposed to remove
the clinical labor associated with this additional clinical staff
member pending the receipt of additional information. We also proposed
to remove 1 impervious staff gown (SB027), 1 surgical mask with face
shield (SB034), and 1 pair of shoe covers (SB039) pending more
information about the additional clinical staff member.
We proposed to remove the clinical labor time for the ``Review home
care instructions, coordinate visits/prescriptions'' (CA035) activity.
CPT code 46500 is typically billed with a same day E/M service, and we
believe that it would be duplicative to assign clinical labor time for
reviewing home care instructions given that this task would typically
be done during the same day E/M service. We also proposed to refine the
equipment times in accordance with our standard equipment time
formulas.
The following is a summary of the public comments we received on
our proposals involving CPT code 46500.
Comment: Many commenters disagreed with the proposed work RVU

[[Page 59536]]

of 1.74 for CPT code 46500 and stated that CMS should finalize the RUC-
recommended work RVU of 2.00. Commenters stated that they disagreed
with CMS calculating intraservice time ratios to account for changes in
work time, and that CPT code 46500 possesses a negative IWPUT, which
makes the use of time ratios particularly inappropriate.
Response: We disagree with the commenters and continue to believe
that the use of time ratios is one of several reasonable methods for
identifying potential work RVUs for particular PFS services,
particularly when the alternative values do not account for information
that suggests the amount of time involved in furnishing the service has
changed significantly. We reiterate that, consistent with the statute,
we are required to value the work RVU based on the relative resources
involved in furnishing the service, which include time and intensity.
When our review of recommended values reveals that changes in the
resource of time have been unaccounted for in a recommended RVU, then
we believe we have the obligation to account for that change in
establishing work RVUs since the statute explicitly identifies time as
one of the two elements of the work RVUs. We recognize that it would
not be appropriate to develop work RVUs solely based on time given that
intensity is also an element of work, but in applying the time ratios,
we are using derived intensity measures based on current work RVUs for
individual procedures. Were we to disregard intensity altogether, the
work RVUs for all services would be developed based solely on time
values and that is definitively not the case, as indicated by the many
services that share the same time values but have different work RVUs.
(As an example, CPT codes 38222, 54231, 55870, 75573, and 78814 all
share identical CY 2019 work times with 15 minutes of preservice time,
30 minutes of intraservice time, and 15 minutes of postservice time;
however these codes have respective CY 2019 work RVUs of 1.44, 2.04,
2.58, 2.55, and 2.20.) Furthermore, we reiterate that we use time
ratios to identify potentially appropriate work RVUs, and then use
other methods (including estimates of work from CMS medical personnel
and crosswalks to key reference or similar codes) to validate these
RVUs. For more details on our methodology, we direct readers to the CY
2017 PFS final rule (81 FR 80272 through 80277). We also note that in
the case of CPT code 46500, we derived our proposed work RVU of 1.74 by
using a direct crosswalk to CPT code 68811 and not a time ratio.
Comment: Several commenters stated that the RUC compared CPT code
46500 to the two key reference services: CPT code 46221
(Hemorrhoidectomy, internal, by rubber band ligation(s)) and CPT code
46930 (Destruction of internal hemorrhoid(s) by thermal energy (e.g.,
infrared coagulation, cautery, radiofrequency)). Commenters stated that
the RUC-recommended work RVU of 2.00 places the value correctly between
the key reference services and results in similar procedure intensity,
whereas the CMS crosswalk to CPT code 68811 was not well aligned with
the top two key reference services due to having a lower intensity.
Response: We disagree with the commenters that our crosswalk to CPT
code 68811 would be less accurate for work valuation than the two key
references chosen by the survey respondents. We note, for example, that
CPT code 46221 has 50 percent more intraservice time than CPT code
46500, and CPT code 46930 has 50 percent less intraservice time than
CPT code 46500, whereas the CMS crosswalk to CPT code 68811 shares the
same 10 minutes of intraservice time as CPT code 46500. We believe that
this closer match in the work time values makes CPT code 68811 a more
appropriate choice for a crosswalk code. We also note that at the RUC
meeting when CPT code 46500 was under review, the specialty presenters
stated that the work RVU had not changed from the historical value of
1.69 before the recommendation was changed to the final value of 2.00.
As we stated in the proposed rule, the 3 percent increase in surveyed
work time for CPT code 46500 matches a 3 percent increase in the
historic work RVU of the code, from 1.69 to 1.74. We continue to
believe that this is the most accurate value to finalize for CPT code
46500.
Comment: Several commenters compared CPT code 46500 to CPT code
68810 (Probing of nasolacrimal duct, with or without irrigation) and
noted that these codes have the same intraservice work time but the
comparison code includes a lower level follow-up visit and therefore
correctly has a lower work RVU. Commenters stated that CPT code 46500
includes a follow-up office visit with an anoscopy to determine the
effectiveness of the treatment and to monitor for infection or sepsis
which adds work to the visit. Commenters stated that the proposed CMS
crosswalk to CPT code 68811 includes an even lower level office visit
(CPT code 99211) than the office visit in CPT code 68810, which
indicated that it was an inappropriate choice for a crosswalk.
Response: We continue to disagree with the commenters that the CMS
crosswalk to CPT code 68811 would provide an inappropriate work
valuation for CPT code 46500 based on the differences in postoperative
work and work time. We would like to clarify again that we used CPT
code 68811 as our crosswalk, not CPT code 68810, and we do not
understand the comparisons to CPT code 68810 suggested by the
commenters. Regarding our crosswalk code, while it is true that CPT
code 68811 does not contain a level three (CPT code 99213) office visit
in its global period like CPT code 46500, the code does include half of
a discharge visit (CPT code 99238) in its global period, which is
missing from the reviewed code. Under the building block methodology,
the combined work RVU and the work time of a half discharge visit (CPT
code 99238) and a level 1 office visit (CPT code 99211) would equal
0.82 RVUs and 26 minutes. This is approximately equal to the level 3
office visit (CPT code 99213 with 0.97 work RVUs and 23 minutes of work
time) in the global period of CPT code 46500. As a result, we do not
agree with the commenters that CPT code 46500 has a significantly
greater amount of postservice work and postservice work time than our
crosswalk code.
Comment: Several commenters responded to our request for more
information about why the clinical labor associated with the additional
staff member was left out of previous reviews and what activities the
additional staff member would be undertaking during the procedure.
Commenters stated that two clinical staff are needed to assist the
physician during the intraservice portion of the service: one staff
person is handling suction and holding the retractor while the surgeon
identifies and injects anesthetic and sclerosant into the poles of the
hemorrhoids, and the second staff person is handing supplies (syringes,
gauze) and taking soiled supplies away. The commenters stated that one
staff person will assist with tasks such as irrigation, suction, etc.
and one circulating staff person will hand syringes, sponges, etc. to
the physician.
Response: We appreciate the additional feedback from the commenters
regarding what activities the additional staff member would be
undertaking during the procedure, although we note that we did not
receive a response regarding why the clinical labor associated with
this additional staff member was left out of previous reviews. After
reviewing the

[[Page 59537]]

additional information supplied by the commenters, we are not
finalizing our proposal to remove the clinical labor time for the
``Assist physician or other qualified healthcare professional'' (CA018)
activity or the proposal to remove 1 impervious staff gown (SB027), 1
surgical mask with face shield (SB034), and 1 pair of shoe covers
(SB039). We are finalizing the RUC-recommended values for these direct
PE inputs.
Comment: Several commenters disagreed with the proposal to remove
the clinical labor time for the ``Review home care instructions,
coordinate visits/prescriptions'' (CA035) activity. Commenters stated
that this clinical activity was not duplicative with the same day E/M
office visit, as the home care instructions directly pertain to the
procedure and would not be provided during an evaluation of the
patient.
Response: We disagree with the commenters that home care
instructions would not be provided during the same day E/M visit. The
commenters did not provide a rationale to explain why home care
instructions would not be provided during the same day E/M visit, which
also directly pertains to the procedure. We continue to believe that it
would be duplicative to assign clinical labor time for this task, as we
believe that the home care instructions would be furnished during the
same day E/M visit.
Comment: One commenter stated that CMS did not indicate what amount
of service period time was removed from the calculation of the
equipment time, and that this made it difficult to determine the
accuracy of the refinements. The commenter requested more information
about this change.
Response: For the anoscope with light source (ES002) equipment, we
removed the clinical labor for the CA029 and CA035 clinical labor
activities in accordance with our standard equipment time formula for
scopes.
After consideration of the public comments, we are finalizing the
work RVU for CPT code 46500 as proposed. We are finalizing the RUC-
recommended direct PE inputs for this code, with the exception of our
refinement to the CA035 clinical labor activity and standard equipment
time refinements as detailed above.
(22) Removal of Intraperitoneal Catheter (CPT Code 49422)
In October 2016, CPT code 49422 (Removal of tunneled
intraperitoneal catheter) was identified as a site of service anomaly
because Medicare data from 2012-2014 indicated that it was performed
less than 50 percent of the time in the inpatient setting, yet it
included inpatient hospital E/M services within the 10-day global
period. The code was resurveyed using a 0-day global period for the
April 2017 RUC meeting. For CY 2019, we proposed the RUC-recommended
work RVU of 4.00 for CPT code 49422.
We did not propose any direct PE refinements for this code family.
The following is a summary of the public comments we received on
our proposals involving CPT code 49422.
Comment: Commenters were supportive of our proposal of the RUC-
recommended work RVUs. Commenters also supported the change in global
period to a 0-day global.
Response: We thank commenters for their support.
After consideration of the public comments, we are finalizing the
RUC-recommended work RVU and direct PE inputs for CPT code 49422 as
proposed.
(23) Dilation of Urinary Tract (CPT Codes 50436, 50437, 52334, and
74485)
In October 2014, the CPT Editorial Panel deleted 6 codes and
created 12 new codes to describe genitourinary catheter procedures and
bundle inherent imaging services. In January 2015, the specialty
societies indicated that CPT code 50395 (Introduction of guide into
renal pelvis and/or ureter with dilation to establish nephrostomy
tract, percutaneous), which was identified as part of the family, would
be referred to the CPT Editorial Panel to clear up any confusion with
overlap in physician work with CPT code 50432 (Placement of nephrostomy
catheter, percutaneous, including diagnostic nephrostogram and/or
ureterogram when performed, imaging guidance (e.g., ultrasound and/or
fluoroscopy) and all associated radiological supervision and
interpretation). In September 2017, the CPT Editorial Panel deleted CPT
code 50395 and created 2 new codes to report dilation of existing
tract, and establishment of new access to the collecting system,
including percutaneous, for an endourologic procedure including imaging
guidance (e.g., ultrasound and/or fluoroscopy), all associated
radiological supervision and interpretation, as well as post procedure
tube placement when performed.
The specialty society surveyed the new CPT code 50436 (Dilation of
existing tract, percutaneous, for an endourologic procedure including
imaging guidance (e.g., ultrasound and/or fluoroscopy) and all
associated radiological supervision and interpretation, as well as post
procedure tube placement, when performed), and the RUC recommended a
total time of 70 minutes, intraservice time of 30 minutes, and a work
RVU of 3.37. The RUC indicated that its recommended work RVU for this
CPT code is identical to the work RVU of the CPT code being deleted,
even though imaging guidance CPT code 74485 has now been bundled into
the valuation of the CPT code. The RUC provided two key reference CPT
codes to support its recommendation: CPT code 50694 (Placement of
ureteral stent, percutaneous, including diagnostic nephrostogram and/or
ureterogram when performed, imaging guidance (e.g., ultrasound and/or
fluoroscopy), and all associated radiological supervision and
interpretation; new access, without separate nephrostomy catheter) with
total time of 111 minutes, intraservice time of 62 minutes, and a work
RVU of 5.25; and CPT code 50695 (Placement of ureteral stent,
percutaneous, including diagnostic nephrostogram and/or ureterogram
when performed, imaging guidance (e.g., ultrasound and/or fluoroscopy),
and all associated radiological supervision and interpretation; new
access, with separate nephrostomy catheter), with total time of 124
minutes and intraservice time of 75 minutes, and a work RVU of 6.80. To
further support its recommendation, the RUC also referenced CPT code
52287 (Cystourethroscopy, with injection(s) for chemodenervation of the
bladder) with total time of 58 minutes, intraservice time of 21
minutes, and a work RVU of 3.37.
We disagreed with the RUC that the work RVU for this CPT code
should be the same as the CPT code being deleted. Survey respondents
indicated that the total time for completing the service described by
the new CPT code is nearly 30 minutes less than the existing CPT code,
even though imaging guidance was described as part of the procedure. We
also noted that the reference CPT codes both have substantially higher
total and intraservice times than CPT code 50436. We considered a
number of parameters to arrive at our proposed work RVU of 2.78,
supported by a crosswalk to CPT code 31646 (Bronchoscopy, rigid or
flexible, including fluoroscopic guidance, when performed; with
therapeutic aspiration of tracheobronchial tree, subsequent, same
hospital stay). We examined the intraservice time ratio for the new CPT
code in relation to the combination of CPT codes that the service
represents and found that this would support a work RVU of 2.55. We
also calculated the intraservice time ratio for the new CPT code in
relation to each of the two

[[Page 59538]]

reference CPT codes. For the comparison with CPT code 50694, the
intraservice time ratio is 2.54, while the comparison with the second
reference CPT code 50695 yields an intraservice time ratio of 2.72. We
took the highest of these three values, 2.72, and found a corresponding
crosswalk that we believe appropriately values the service described by
the new CPT code. Therefore, we proposed a work RVU of 2.78 for CPT
code 50436.
The specialty society also surveyed the new CPT code 50437
(Dilation of existing tract, percutaneous, for an endourologic
procedure including imaging guidance (e.g., ultrasound and/or
fluoroscopy) and all associated radiological supervision and
interpretation, as well as post procedure tube placement, when
performed; including new access into the renal collecting system) and
the RUC recommended a total time of 100 minutes, an intraservice time
of 60 minutes, and a work RVU of 5.44. The recommended intraservice
time of 60 minutes reflects the 75th percentile of survey results,
rather than the median survey time, which is typically used for
determining the intraservice time for new CPT codes. The RUC justified
the use of the higher intraservice time because they believe the time
better represents the additional time needed to introduce the guidewire
into the renal pelvis and/or ureter, above and beyond the work involved
in performing CPT code 50436. The RUC compared this CPT code to CPT
code 52235 (Cystourethroscopy, with fulguration (including cryosurgery
or laser surgery) and/or resection of; MEDIUM bladder tumor(s) (2.0 to
5.0 cm)), with total time of 94 minutes, intraservice time of 45
minutes, and a work RVU of 5.44. The RUC also cited as support the
second key reference CPT code 50694 (Placement of ureteral stent,
percutaneous, including diagnostic nephrostogram and/or ureterogram
when performed, imaging guidance (e.g., ultrasound and/or fluoroscopy),
and all associated radiological supervision and interpretation; new
access, without separate nephrostomy catheter) with total time 111
minutes, intraservice time 62 minutes, and a work RVU of 5.25.
We did not agree with the RUC's recommended work RVU because we
believed that the intraservice time for this CPT code should reflect
the survey median rather than the 75th percentile. There is no
indication that the additional work of imaging guidance was
systematically excluded by survey respondents when estimating the time
needed to furnish the service. Therefore, we proposed to reduce the
intraservice time for CPT code 50437 from the RUC- recommended 60
minutes to the survey median time of 45 minutes. We noted that this is
still 15 minutes more than the intraservice time for CPT code 50436,
primarily for the provider to introduce the guidewire into the renal
pelvis and/or ureter. We welcomed comments about the amount of time
needed to furnish this procedure.
With the revised intraservice time of 45 minutes and a total time
of 85 minutes, we believed that the RUC-recommended work RVU for this
CPT code is overstated. When we applied the increment between the RUC-
recommended values for between CPT codes 50436 and 50437 (2.07 work
RVUs) in addition to our proposed work RVU for CPT code 50436, we
estimated that this CPT code was more accurately represented by a work
RVU of 4.83. This value is supported by a crosswalk to CPT code 36902
(Introduction of needle(s) and/or catheter(s), dialysis circuit, with
diagnostic angiography of the dialysis circuit, including all direct
puncture(s) and catheter placement(s), injection(s) of contrast, all
necessary imaging from the arterial anastomosis and adjacent artery
through entire venous outflow including the inferior or superior vena
cava, fluoroscopic guidance, radiological supervision and
interpretation and image documentation and report; with transluminal
balloon angioplasty, peripheral dialysis segment, including all imaging
and radiological supervision and interpretation necessary to perform
the angioplasty), which has an intraservice time of 40 minutes and a
total time of 86 minutes. We believed that CPT code 36902 describes a
service that is similar to the new CPT code 50437) and therefore
provides a reasonable crosswalk. We proposed a work RVU of 4.83 for CPT
code 50437.
We proposed the RUC-recommended work RVU of 3.37 for CPT code 52334
(Cystourethroscopy with insertion of ureteral guide wire through kidney
to establish a percutaneous nephrostomy, retrograde) and the RUC-
recommended work RVU of 0.83 for CPT code 74485 (Dilation of ureter(s)
or urethra, radiological supervision and interpretation).
For the direct PE inputs, we proposed to remove the clinical labor
time for the ``Confirm availability of prior images/studies'' (CA006)
activity for CPT code 52334. This code does not currently include this
clinical labor time, and unlike the two new codes in the family (CPT
codes 50436 and 50437), CPT code 52334 does not include imaging
guidance in its code descriptor. When CPT code 52334 is performed with
imaging guidance, it would be billed together with a separate imaging
code that already includes clinical labor time for confirming the
availability of prior images. As a result, we believed that it would be
duplicative to include this clinical labor time in CPT code 52334.
The following is a summary of the public comments we received on
our proposals involving the Dilation of Urinary Tract family of codes.
Comment: Several commenters responded to our proposals regarding
work RVUs for this family of codes. In general, commenters expressed
support for our proposed work RVU of 3.37 for CPT code 52334 and 0.83
for CPT code 74485.
Response: We are finalizing the work RVUs for each of these codes
as proposed.
Comment: Several commenters did not support our proposals regarding
the work RVU for CPT codes 50436 and 50437. The RUC and other
commenters stated that CMS misunderstood the RUC's summary of results
(SOR) and the purpose of the reference codes and the code comparisons
as part of their review process. They suggested that our rejection of
the RUC recommendation for CPT code 50436 was based on a mistake about
the codes that the RUC cited as reference codes.
Response: We consider a variety of documents and data during our
review of the RUC's recommended work RVU for a code. The two reference
codes cited in the excel summary work RVU spreadsheet for CPT code
50436 were CPT codes 50694 and 50695, while the two reference codes
cited in the SOR were CPT codes 52287 52214. In other words, there was
an inconsistency in the documentation. We believe that any of the four
reference codes cited in the documentation and/or data are valid points
of comparison for evaluating whether the RUC's recommended work RVUs
are appropriate.
Comment: Some commenters did not agree with CMS's use of
intraservice time ratios as a factor in determining whether a CPT code
is appropriately valued. The commenters maintained that CMS's use of
these parameters is inappropriate and demonstrates our prioritization
of time-related factors above the intensity and complexity of the
service.
Response: We routinely use intraservice time ratios to determine
whether a recommended work RVU for a new CPT code adequately reflects
efficiencies gained when codes are bundled and/or providers become more
efficient at furnishing services and we disagree with commenters that
time

[[Page 59539]]

ratios are an inappropriate metric. We identify a crosswalk for the
purpose of establishing the work RVU by comparing the survey code to
other codes in the PFS with similar intraservice and total times and
also by considering the intensity among codes with similar times. We
disagree that this means we are prioritizing time parameters over other
factors that are relevant in considering a code's value.
Comment: Commenters disagreed with CMS's proposed work RVU of 2.78
for CPT code 50436, citing CMS's inappropriate use of time parameters
in comparing this code with the deleted CPT code 50395.
Response: Even after taking into consideration the bundling of the
deleted code, CPT 50395, with CPT code 74485, we believe that there are
efficiencies in the work that are not adequately reflected in the RUC-
recommended work RVU for this new code, CPT 50436. We examined a number
of parameters in seeking an appropriate crosswalk code for CPT 50436,
including the intraservice time ratio for this new code in relation to
the combination of CPT codes that the service represents and the
intraservice time ratio for the new code in relation to each of the
RUC's two reference codes. Our crosswalk, CPT code 31646, reflects the
work RVU (2.78) corresponding to the most appropriate, and the highest,
work RVU (2.72) associated with these calculations. Our identification
of a crosswalk code is not dictated by the time parameter calculations
alone, but rather is based on a combination of the time parameters and
our understanding of the intensity involved in furnishing the service.
If we had been looking only at time parameters, we might have chosen a
CPT code with a work RVU closest to the lowest of the time parameter
calculations (2.54). We continue to believe that the most appropriate
crosswalk is CPT code 31646, and we are finalizing our proposed work
RVU of 2.78 for CPT code 50436.
Comment: As with CPT code 50436, commenters suggested that CMS
mistook the codes included in the SOR as the codes that the RUC cited
as reference codes.
Response: As we indicated in our response to this comment for CPT
code 50436, we consider all documentation and data provided by the RUC
in our assessment of the work RVU for a code. The reference and
comparison CPT codes cited in the SOR did not match those in the
summary work RVU spreadsheet.
Comment: Several commenters disagreed with our method of proposing
a work RVU based on the incremental differences in the RUC-recommended
work RVU between codes. Commenters stated that this erroneously
considers all time components as having equal intensity.
Response: We generally apply this methodology where we agree with,
and seek to maintain the relativity between two codes reflected in the
RUC recommendations, but we disagree with the RUC-recommended work RVU
for one or both of the codes. We also considered, as an alternative,
whether it would be more appropriate to use proportional increments
rather than absolute differences between two RUC-recommended work RVUs.
Under that scenario, we would have proposed a work RVU of 4.49 for CPT
code 50437 [(2.78 * 5.44)/3.37 = 4.49]. However, since our general
approach involves applying the absolute difference in work RVUs, our
proposed value for CPT code 50437 was 4.83 work RVUs. We thank the
commenter for pointing out our calculation error, due to which our
proposed work RVU should have been 4.85 instead of 4.83. We continue to
believe that relative difference in the RUC's recommendations for work
RVUs between codes is a useful and appropriate tool for determining
work RVUs for CPT codes, and we are finalizing a work RVU of 4.85 for
CPT code 50437 based on a comparison with CPT code 36902, which has a
work RVU of 4.83.
Comment: Several commenters disagreed with the proposal to remove
the clinical labor time for the ``Confirm availability of prior images/
studies'' (CA006) activity for CPT code 52334. Commenters stated that
the equivalent of the CA006 clinical labor activity did not exist when
this service was last reviewed by the Practice Expense subcommittee in
2002, and that many surgical procedures and other types of services
that do not have imaging bundled involve the physician reviewing images
and studies before performing the service. Commenters stated that this
review is not duplicative with image-guidance codes as it instead
involves reviewing distinct previous studies.
Response: We continue to believe that this clinical labor time
should be removed because it is duplicative, as CPT code 52334 would be
billed together with a separate imaging code that already includes
clinical labor time for confirming the availability of prior images
when it is performed with imaging guidance. We believe that the
commenters may be conflating the absence of the CA006 clinical labor
activity when CPT code 52334 was previously reviewed with the lack of
any clinical labor for reviewing images that did not exist previously
in this specific code. There were hundreds of procedures that included
clinical labor for reviewing images prior to the creation of the CA006
clinical labor code, and CPT code 52334 was not one of them. Similarly,
while we agree that there are many services that do not have bundled
imaging and nonetheless include the physician reviewing images and
studies before performing the service, this does not explain why CPT
code 52334 would require clinical labor time for confirming the
availability of prior images and studies when the service did not
include this clinical labor time previously. We continue to believe
that the inclusion of this clinical labor time would be duplicative for
this service.
Comment: One commenter requested that CPT code 52334 be added to
the phase-in list for codes with significant PE RVU reductions.
Response: Section 1848(c)(7) of the Act, as added by section 220(e)
of the PAMA, specifies that for services that are not new or revised
codes, if the total RVUs for a service for a year would otherwise be
decreased by an estimated 20 percent or more as compared to the total
RVUs for the previous year, the applicable adjustments in work, PE, and
MP RVUs shall be phased-in over a 2-year period. We proposed to exempt
CPT code 52334 from the phase-in due to the fact that it is part of the
same family of codes that included new CPT codes 50436 and 50437. We
have previously finalized this policy through rulemaking, stating that
significant coding revisions within a family of codes can change the
relationships among codes to the extent that it changes the way that
all services in the group are reported, even if some individual codes
retain the same number or, in some cases, the same descriptor.
Excluding codes from the phase-in when there are significant revisions
to the code family also helps to maintain the appropriate rank order
among codes in the family, avoiding years for which RVU changes for
some codes in a family are in transition while others were fully
implemented. For additional information regarding the phase-in of
significant RVU reductions, we direct readers to the CY 2016 PFS final
rule with comment period (80 FR 70927 through 70929).
(24) Transurethral Destruction of Prostate Tissue (CPT Codes 53850,
53852, and 53854)
In September 2017, the CPT Editorial Panel created a new code (CPT
code

[[Page 59540]]

53854) to report transurethral destruction of prostate tissue by
radiofrequency-generated water vapor thermotherapy. CPT codes 53850
(Transurethral destruction of prostate tissue; by microwave
thermotherapy) and 53852 (Transurethral destruction of prostate tissue;
by radiofrequency thermotherapy) were also included for review as part
of the same family of codes.
For CPT code 53850 (Transurethral destruction of prostate tissue;
by microwave thermotherapy), the RUC recommended a work RVU of 5.42,
supported by a direct crosswalk to CPT code 33272 (Removal of
subcutaneous implantable defibrillator electrode) with a total time of
151 minutes, intraservice time of 45 minutes, and a work RVU of 5.42.
The RUC indicated that a work RVU of 5.42 accurately reflects the
lowest value of the three CPT codes in this family. We proposed the
work RVU of 5.42 for CPT code 53850, as recommended by the RUC.
The RUC recommended a work RVU of 5.93 for CPT code 53852
(Transurethral destruction of prostate tissue; by radiofrequency
thermotherapy) and for CPT code 53854 (Transurethral destruction of
prostate tissue; by radiofrequency generated water vapor
thermotherapy). We proposed the RUC-recommended work RVU of 5.93 for
CPT code 53852.
CPT code 53854 is a service reflecting the use of a new technology,
``radiofrequency generated water vapor thermotherapy,'' as distinct
from CPT code 53852, which describes destruction of tissue by
``radiofrequency thermotherapy.'' The RUC indicated that this CPT code
is the most intense of the three CPT codes in this family, thereby
justifying a work RVU identical to that of CPT code 53852, despite
lower intraservice and total times. The RUC stated that 15 minutes of
post service time is appropriate due to greater occurrence of post-
procedure hematuria necessitating a longer monitoring time. However,
the post-service monitoring time for this CPT code, 15 minutes, is
identical to that for CPT code 53852. We did not agree with the
explanation provided by the RUC for recommending a work RVU identical
to that of CPT code 53852, given that the total time is 5 minutes
lower, and the post service times are identical. Both the intraservice
time ratio between this new CPT code and CPT code 53852 (4.94) and the
total time ratio between the two CPT codes (5.72) suggest that the RUC-
recommended work RVU of 5.93 overestimates the work involved in
furnishing this service. We reviewed other 90-day global CPT codes with
similar times and identified CPT code 24071 (Excision, tumor, soft
tissue of upper arm or elbow area, subcutaneous; 3 cm or greater) with
a total time of 183 minutes, intraservice time of 45 minutes, and a
work RVU of 5.70 as an appropriate crosswalk. We believed that this
would be a better reflection of the work involved in furnishing CPT
code 53854, and therefore, we proposed a work RVU of 5.70 for this CPT
code. We welcomed comments about the time and intensity required to
furnish this new service. Since this CPT code reflects the use of a new
technology, it will be reviewed again in 3 years.
For the direct PE inputs, we proposed to add a new supply (SA128:
``kit, Rezum delivery device''), a new equipment item (EQ389:
``generator, water thermotherapy procedure''), and proposed to update
the price of two supplies (SA036: ``kit, transurethral microwave
thermotherapy'' and SA037: ``kit, transurethral needle ablation
(TUNA)'') after reviewing invoices that we received. We noted that
these invoices were submitted along with additional information listing
the vendor discount for these supplies and equipment. We appreciated
the inclusion of the discounted prices on these invoices, and we
encouraged other invoice submissions to provide the discounted price as
well, where available. Based on market research on supply and equipment
pricing carried out by our contractors, we believe that a vendor
discount of 10-15 percent is common on many supplies and equipment.
Since we are obligated by statute to establish RVUs for each service as
required based on the resource inputs required to furnish the typical
case of a service, we have concerns that relying on invoices for supply
and equipment pricing absent these vendor discounts may overestimate
the resource cost of some services. We encouraged the submission of
additional invoices that include the discounted price of supplies and
equipment to more accurately assess the market cost of these resources.
The following is a summary of the public comments we received on
our proposals involving the Transurethral Destruction of Prostate
Tissue family of codes.
Comment: Several commenters expressed support for our proposed work
RVU of 5.42 for CPT code 53850 and 5.93 for CPT code 53852, which
reflect the RUC's recommendations for these two codes.
Response: We appreciate the commenters' support and we are
finalizing a work RVU of 5.42 for CPT code 53850 and a work RVU of 5.93
for CPT code 53852.
Comment: A commenter pointed out that there is an error in our
description of the RUC's time components for this code. We stated that
there was less post service time for CPT code 53854 than for CPT code
53852 when, in fact, both codes have a post service time of 15 minutes.
The intraservice time between the two codes differs by 5 minutes, with
CPT code 53854 having 5 fewer minutes than CPT code 53852.
Response: We thank the commenter for informing us of the error. We
note, however, that this does not affect our proposal which is based on
a comparison of both intraservice and total time ratios.
Comment: Several commenters, ranging from device manufacturers and
professional associations, disagreed with our proposed value of 5.70
for CPT code 53854 instead of the RUC-recommended work RVU of 5.93.
Commenters stated that the work involved in furnishing the service
described by CPT code 53854 is the most intense of the three CPT codes
in this family because of the added risk of bleeding, urinary retention
and damage to the external urinary sphincter with resultant
incontinence of urine if not performed properly. Commenters also urged
CMS to approach the time results from the survey for this code with
caution, as few practitioners are likely to have had much experience
with the new technology described by this service.
Response: In our proposal, we requested additional information from
stakeholders about the time and intensity required to furnish this
service because we were not convinced that the work involved in
furnishing the service described by CPT code 53854 is more intense than
the work involved in furnishing CPT code 53852, which the RUC used as a
reference code in developing their recommendation. We were convinced by
commenters, however, that the additional risk in furnishing this
service supports a higher work RVU than what we proposed. Therefore, we
are finalizing a work RVU of 5.93 for this CPT code, as recommended by
the RUC.
Comment: One commenter stated that both CPT codes should be subject
to the phase-in for CY 2019 because they will decrease more than 20
percent and are not new or revised codes. The commenter urged CMS to
add CPT codes 52380 and 52382 to the list of codes subject to the
phase-in.
Response: Section 1848(c)(7) of the Act, as added by section 220(e)
of the PAMA, specifies that for services that

[[Page 59541]]

are not new or revised codes, if the total RVUs for a service for a
year would otherwise be decreased by an estimated 20 percent or more as
compared to the total RVUs for the previous year, the applicable
adjustments in work, PE, and MP RVUs shall be phased-in over a 2-year
period. We proposed to exempt CPT codes 52380 and 52382 from the phase-
in of significant RVU reductions required by section 1848(b)(11) of the
Act because these codes are part of the same family of codes that
included new CPT code 53854. We have previously finalized this policy
through rulemaking, stating that significant coding revisions within a
family of codes can change the relationships among codes to the extent
that it changes the way that all services in the group are reported,
even if some individual codes retain the same number or, in some cases,
the same descriptor. Excluding codes from the phase-in when there are
significant revisions to the code family also helps to maintain the
appropriate rank order among codes in the family, avoiding years for
which RVU changes for some codes in a family are in transition while
others were fully implemented. For additional information regarding the
phase-in of significant RVU reductions, we direct readers to the CY
2016 PFS final rule with comment period (80 FR 70927 through 70929).
Comment: One commenter stated that they were concerned about
substantial reductions in billable staff time and supply costs
associated with CPT codes 53850 and 53852. The commenter stated that
reductions in billable staff time will require treating physicians to
minimize non-procedural time which may include: Comfort control
protocols; patient expectation management; patient post-procedure
instructions; and recommended best practices for follow-up care. The
commenter stated that they were concerned that the proposed supply
costs are not in line with actual pricing or with actual cost increases
for manufacturing of the product, and indicated that significant
reductions in reimbursement will limit patient access to a therapy with
demonstrated safety, effectiveness, and cost efficacy.
Response: We appreciate the feedback from the commenter, and we are
sensitive to the need for accurate payment under the PFS to ensure that
beneficiaries maintain access to care. However, we note that we
proposed the RUC-recommended direct PE inputs for this family of codes
without refinement, and the decreases in clinical staff time for these
procedures were almost entirely due to shorter surveyed intraservice
work times and the removal of office visits in the postoperative
portion of the global period as identified by the RUC. We agree with
the RUC that fewer follow-up office visits and shorter intraservice
times are now typical for these procedures, and we do not believe that
the resulting decreases in clinical labor time will create barriers to
accessing care. With regard to changes in the proposed supply costs, we
direct readers to our discussion of the market-based supply and
equipment pricing update in section II.B. of this final rule. We
encourage stakeholders to continue to provide feedback concerning
accurate supply and equipment pricing.
After consideration of the comments, we are finalizing the RUC-
recommended work RVUs and direct PE inputs for the three codes in the
Transurethral Destruction of Prostate Tissue family of codes.
(25) Vaginal Treatments (CPT Codes 57150 and 57160)
CPT codes 57150 (Irrigation of vagina and/or application of
medicament for treatment of bacterial, parasitic, or fungoid disease)
and 57160 (Fitting and insertion of pessary or other intravaginal
support device) were identified as potentially misvalued on a screen of
0-day global services reported with an E/M visit 50 percent of the time
or more, on the same day of service by the same patient and the same
practitioner, that have not been reviewed in the last 5 years with
Medicare utilization greater than 20,000. For CY 2019, we proposed the
RUC-recommended work RVU of 0.50 for CPT code 57150 and the RUC-
recommended work RVU of 0.89 for CPT code 57160.
We did not propose any direct PE refinements for this code family.
The following is a summary of the public comments we received on
our proposals involving the Vaginal Treatments family of codes.
Comment: Commenters were supportive of our proposal of the RUC-
recommended work RVUs.
Response: We thank commenters for their support.
After consideration of the public comments, we are finalizing the
RUC-recommended work RVUs and direct PE inputs for CPT codes 57150 and
57160 as proposed.
(26) Biopsy of Uterus Lining (CPT Codes 58100 and 58110)
CPT code 58100 (Endometrial sampling (biopsy) with or without
endocervical sampling (biopsy), without cervical dilation, any method)
was identified as potentially misvalued on a screen of 0-day global
services reported with an E/M visit 50 percent of the time or more, on
the same day of service by the same patient and the same practitioner,
that have not been reviewed in the last 5 years with Medicare
utilization greater than 20,000. CPT code 58110 (Endometrial sampling
(biopsy) performed in conjunction with colposcopy) was also included
for review as part of the same family of codes. For CY 2019, we
proposed the RUC-recommended work RVU of 1.21 for CPT code 58100 and
the RUC-recommended work RVU of 0.77 for CPT code 58110.
For the direct PE inputs, we proposed to remove the clinical labor
time for the ``Review/read post-procedure x-ray, lab and pathology
reports'' (CA028) activity for CPT code 58100. This code is typically
billed with a same day E/M service, and we believe that it would be
duplicative to assign clinical labor time for reviewing reports given
that this task would typically be done during the same day E/M service.
We also proposed to refine the equipment times in accordance with our
standard equipment time formulas.
The following is a summary of the public comments we received on
our proposals involving the Biopsy of Uterus Lining family of codes.
Comment: Several commenters stated that they appreciated that CMS
proposed the RUC-recommended work RVU of 1.21 for CPT code 58100 and
the RUC-recommended work RVU of 0.77 for CPT code 58110.
Response: We appreciate the support for our proposals from the
commenters.
Comment: Several commenters disagreed with the CMS proposal to
remove the clinical labor time for the ``Review/read post-procedure x-
ray, lab and pathology reports'' (CA028) activity for CPT code 58100.
Commenters stated that this clinical labor activity was not
duplicative, as CA028 is designed specifically for post-procedure
activity during the postservice of the service period which would not
overlap with activities in the E/M office visit, which typically occur
prior to the procedure and are listed as a preservice clinical labor
activity. Commenters stated that the clinical description of the
service for CPT code 58100 clearly notes that the E/M service is done
the day before the service and that the patient returns for the biopsy.
Response: We disagree with the commenters' statements about the
timing of the E/M office visit. The same day billing data indicates
that CPT code 58100 is typically billed with an E/M office visit on the
same day (59 percent of the time), and it therefore seems clear that
the E/M office visit typically takes place during the day of the
procedure,

[[Page 59542]]

not the day before. We do not understand how the claims analysis fits
with the statement from the commenters that the E/M service happens the
day before the procedure, especially since CPT code 58100 has a 0-day
global period that does not include preoperative care that takes place
the day before the procedure. We continue to believe that it would be
duplicative to assign clinical labor time for reviewing reports given
that this task would typically be done during the same day E/M service.
We believe that this clinical labor would be carried out during the
same day E/M visit.
After consideration of the public comments, we are finalizing the
work RVUs and the direct PE inputs for the codes in the Biopsy of
Uterus Lining family of codes as proposed.
(27) Injection Greater Occipital Nerve (CPT Code 64405)
CPT code 64405 (Injection, anesthetic agent; greater occipital
nerve) was identified as potentially misvalued on a screen of 0-day
global services reported with an E/M visit 50 percent of the time or
more, on the same day of service by the same patient and the same
practitioner, that have not been reviewed in the last 5 years with
Medicare utilization greater than 20,000. For CY 2019, we proposed the
RUC-recommended work RVU of 0.94 for CPT code 64405.
For the direct PE inputs, we proposed to refine the equipment time
for the exam table (EF023) in accordance with our standard equipment
time formulas.
The following is a summary of the public comments we received on
our proposals involving CPT code 64405.
Comment: Some commenters expressed support for our proposal to
accept the RUC-recommended work RVU for this code.
Response: We appreciate the support from the commenters for our
proposals.
After consideration of the public comments, we are finalizing the
work RVU and the direct PE inputs for CPT code 64405 as proposed.
(28) Injection Digital Nerves (CPT Code 64455)
CPT code 64455 (Injection(s), anesthetic agent and/or steroid,
plantar common digital nerve(s) (e.g., Morton's neuroma)) was
identified as potentially misvalued on a screen of 0-day global
services reported with an E/M visit 50 percent of the time or more, on
the same day of service by the same patient and the same practitioner,
that have not been reviewed in the last 5 years with Medicare
utilization greater than 20,000. For CY 2019, we proposed the RUC-
recommended work RVU of 0.75 for CPT code 64455.
For the direct PE inputs, we proposed to refine the equipment time
for the exam table (EF023) in accordance with our standard equipment
time formulas.
The following is a summary of the public comments we received on
our proposals involving CPT code 64455.
Comment: Several commenters supported the CMS proposal of the RUC-
recommended work RVU of 0.75.
Response: We appreciate the support for our proposals from the
commenters.
After consideration of the public comments, we are finalizing the
work RVU and the direct PE inputs for CPT code 64455 as proposed.
(29) Removal of Foreign Body--Eye (CPT Codes 65205 and 65210)
CPT codes 65205 (Removal of foreign body, external eye;
conjunctival superficial) and 65210 (Removal of foreign body, external
eye; conjunctival embedded (includes concretions), subconjunctival, or
scleral nonperforating) were identified as potentially misvalued on a
screen of 0-day global services reported with an E/M visit 50 percent
of the time or more, on the same day of service by the same patient and
the same practitioner, that have not been reviewed in the last 5 years
with Medicare utilization greater than 20,000.
For CY 2019, we proposed the RUC-recommended work RVU of 0.49 for
CPT code 65205. We noted that the recommendations for this code
included a statement that the work required to perform CPT code 65205
and the procedure itself had not fundamentally changed since the time
of the last review. However, due to the fact that the surveyed
intraservice time had decreased from 5 minutes to 3 minutes, the work
RVU was lowered from the current value of 0.71 to the recommended work
RVU of 0.49, based on a direct crosswalk to CPT code 68200
(Subconjunctival injection). We noted that this recommendation appears
to have been developed under a methodology similar to our ongoing use
of time ratios as one of several methods used to evaluate work. We used
time ratios to identify potential work RVUs and considered these work
RVUs as potential options relative to the values developed through
other options. As we have stated in past rulemaking (such as 82 FR
53032-53033), we did not imply that the decrease in time as reflected
in survey values must equate to a one-to-one or linear decrease in
newly valued work RVUs, as indeed it does not in the case of CPT code
65205 here. Instead, we believed that, since the two components of work
are time and intensity, significant decreases in time should be
reflected in decreases to work RVUs. We appreciate that the RUC-
recommended work RVU for CPT code 65205 has taken these changes in work
time into account, and we support the use of similar methodologies,
where appropriate, in future work valuations.
For CPT code 65210, we disagreed with the RUC-recommended work RVU
of 0.75 and we proposed a work RVU of 0.61 based on a direct crosswalk
to CPT code 92511 (Nasopharyngoscopy with endoscope). This crosswalk
code has the same intraservice time of 5 minutes and 4 additional
minutes of total time as compared to CPT code 65210. We noted that the
recommended intraservice time for CPT code 65210 is decreasing from 13
minutes to 5 minutes (62 percent reduction), and the recommended total
time for CPT code 65210 is decreasing from 25 minutes to 13 minutes (48
percent reduction); however, the RUC-recommended work RVU is only
decreasing from 0.84 to 0.75, which is a reduction of about 11 percent.
As we noted earlier, we do not believe that the decrease in time as
reflected in survey values must equate to a one-to-one or linear
decrease in the valuation of work RVUs, and we did not propose a linear
decrease in the work valuation based on these time ratios. However, we
believe that since the two components of work are time and intensity,
significant decreases in time should be reflected in decreases to work
RVUs, and we do not believe that the recommended work RVU of 0.75
appropriately reflects these decreases in surveyed work time.
Our proposed work RVU of 0.61 is also based on a crosswalk to CPT
code 51700 (Bladder irrigation, simple, lavage and/or instillation),
another recently reviewed code with higher time values and a work RVU
of 0.60. We also noted that two injection codes (CPT codes 20551 and
64455) were reviewed at the same RUC meeting as CPT code 65210, each of
which shared the same intraservice time of 5 minutes and had a higher
total time of 21 minutes. Both of these codes had a RUC-recommended
work RVU of 0.75, which we proposed without refinement for CY 2019. Due
to the fact that CPT code 65210 has a lower total time and a lower
intensity than both of these injection procedures, we did not agree
that CPT code 65210 should be valued at the same work RVU of 0.75. We
believe that our proposed work RVU of 0.61 based on a crosswalk to CPT
code 92511 is a more accurate value for this code.
For the direct PE inputs, we noted that the RUC-recommended
equipment time for the screening lane (EL006)

[[Page 59543]]

equipment in CPT codes 65205 and 65210 was equal to the total work time
in addition to the clinical labor time needed to set up and clean the
equipment. We disagreed that the screening lane would typically be in
use for the total work time, given that this includes the preservice
evaluation time and the immediate postservice time. Although we did not
currently propose to refine the equipment time for the screening lane
in these two codes, we solicited comments on whether the use of the
intraservice work time would be more typical than the total work time
for CPT codes 65205 and 65210.
The following is a summary of the public comments we received on
our proposals involving the Removal of Foreign Body--Eye family of
codes.
Comment: Commenters agreed with the CMS proposal of the RUC-
recommended work RVU for CPT code 65205.
Response: We appreciate the support for our proposal from the
commenters.
Comment: Several commenters disagreed with our statement that the
RUC-recommended work RVU for CPT code 65205 appeared to have been
developed under a methodology similar to the use of time ratios.
Commenters stated that time ratios were not used in arriving at the
value of 0.49 for CPT code 65205, and that the recommended work RVU was
based instead on a crosswalk to the second key reference code from the
survey, CPT code 68200, which requires the same total time to perform
and shares identical intensity and complexity.
Response: We appreciate the additional information provided by the
commenters regarding the methodology behind the recommended work RVU
for CPT code 65205. As we noted in the proposed rule, this
recommendation appeared to have been developed under a methodology
similar to our ongoing use of time ratios; we did not state that the
recommendation was explicitly based on the use of a time ratio.
Comment: Many commenters disagreed with the proposed work RVU of
0.61 for CPT code 65210 and stated that CMS should finalize the RUC-
recommended work RVU of 0.75. Commenters stated that CMS should not use
intraservice time ratios for work valuation as this methodology ignored
the work estimates present in the survey data and the RUC review of
those work estimates. Commenters stated that the RUC-recommended work
values consider intensity and complexity of the work, while CMS
substituted an arbitrary determination of work values based on time and
a subjective estimate of intensity and complexity based on an unknown
and clinically uninformed opinion.
Response: We disagree with the commenters and continue to believe
that the use of time ratios is one of several appropriate methods for
identifying potential work RVUs for particular PFS services,
particularly when the alternative values recommended by the RUC and
other commenters do not account for information provided by surveys
that suggests the amount of time involved in furnishing the service has
changed significantly. We reiterate that, consistent with the statute,
we are required to value the work RVU based on the relative resources
involved in furnishing the service, which include time and intensity.
When our review of recommended values reveals that changes in the
resource of time have been unaccounted for in a recommended RVU, then
we believe we have the obligation to account for that change in
establishing work RVUs since the statute explicitly identifies time as
one of the two elements of the work RVUs. We recognize that it would
not be appropriate to develop work RVUs solely based on time given that
intensity is also an element of work, but in applying the time ratios,
we are using derived intensity measures based on current work RVUs for
individual procedures. Were we to disregard intensity altogether, the
work RVUs for all services would be developed based solely on time
values and that is definitively not the case, as indicated by the many
services that share the same time values but have different work RVUs.
(As an example, CPT codes 38222, 54231, 55870, 75573, and 78814 all
share identical CY 2019 work times with 15 minutes of preservice time,
30 minutes of intraservice time, and 15 minutes of postservice time;
however these codes have respective CY 2019 work RVUs of 1.44, 2.04,
2.58, 2.55, and 2.20.) Furthermore, we reiterate that we use time
ratios to identify potentially appropriate work RVUs, and then use
other methods (including estimates of work from CMS medical personnel
and crosswalks to key reference or similar codes) to validate these
RVUs. For more details on our methodology for developing work RVUs, we
direct readers to the discussion in the CY 2017 PFS final rule (81 FR
80272 through 80277). We also note that in the case of CPT code 65210,
we derived our proposed work RVU of 0.61 by using a direct crosswalk to
CPT code 92511 and not a time ratio.
Comment: Several commenters noted that CPT code 65210 had never
been surveyed and was based on Harvard time which contributed to the
median survey intraservice time of 5 minutes being less than half of
the current value of 13 minutes. Commenters stated that Harvard times
should be not be used for any sort of time comparison, especially when
the code was not originally surveyed by Harvard, and any comparisons
with these work times were inappropriate.
Response: We agree that it is important to use the most recent data
available regarding time, and we note that when many years have passed
between when time is measured, significant discrepancies can occur.
However, we also believe that our operating assumption regarding the
validity of the existing values as a point of comparison is critical to
the integrity of the relative value system as currently constructed.
The times currently associated with codes play a very important role in
PFS ratesetting, both as points of comparison in establishing work RVUs
and in the allocation of indirect PE RVUs by specialty. If we were to
operate under the assumption that previously recommended work times had
routinely been overestimated, this would undermine the relativity of
the work RVUs on the PFS in general, given the process under which
codes are often valued by comparisons to codes with similar times, and
it also would undermine the validity of the allocation of indirect PE
RVUs to physician specialties across the PFS. Instead, we believe that
it is crucial that the code valuation process take place with the
understanding that the existing work times used in the PFS ratesetting
processes are accurate. We recognize that adjusting work RVUs for
changes in time is not always a straightforward process and that the
intensity associated with changes in time is not necessarily always
linear, which is why we apply various methodologies to identify several
potential work values for individual codes. However, we want to
reiterate that we believe it would be irresponsible to ignore changes
in time based on the best data available and that we are statutorily
obligated to consider both time and intensity in establishing work RVUs
for PFS services. For additional information regarding the use of
current work time values in our methodology, we refer readers to our
discussion of the subject in the CY 2017 final rule (81 FR 80273
through 80274).
Comment: Several commenters stated that the procedure described by
CPT code 65210 has not fundamentally changed, and therefore the RUC had
recommended a work RVU at the 25th percentile in accordance with the
recent survey. One commenter stated that the

[[Page 59544]]

intensity of the procedure was also unchanged. Commenters stated that
the crosswalk and reference codes chosen by CMS were clearly not as
intense as the removal of an embedded foreign body described by CPT
code 65210, in which an incision into ocular tissue is required.
Response: We disagree with the commenters that CPT code 65210 has
not fundamentally changed. We note for example that the surveyed work
times have decreased drastically from the prior valuation, and
similarly, the intensity of the service as measured by the survey more
than doubled. These factors do not comport with the statement from the
commenters that intensity of this service is unchanged. We also note
that the RUC-recommended work RVU of 0.75 was a decrease from the
current work RVU of 0.84, which also does not appear to reflect the
idea that the intensity of the service has not changed. We similarly
disagree with the commenters that our crosswalk and reference codes are
not as intense as CPT code 65210. CPT code 92511 in particular
describes a nasopharyngoscopy with endoscope that requires removing
secretions and dried mucus blocking passage to the nasopharynx with
suction and/or forceps. We disagree with the commenters that this
procedure would be less intensive than the removal of a foreign body as
described in CPT code 65210.
Comment: Several commenters disagreed with the CMS comparison of
CPT code 65210 to two injection codes (CPT codes 20551 and 64455) which
were reviewed at the same RUC meeting as CPT code 65210. Commenters
stated that the two referenced codes both have a lower intensity than
CPT code 65210 and therefore they were not appropriate references for
work valuation. Commenters stated that CPT code 65210 has a lower total
time and a higher intensity than both of these injection procedures,
justifying the recommended work RVU of 0.75.
Response: We disagree with the commenters that CPT code 65210 would
typically have a higher intensity than CPT codes 20551 and 64455. These
codes both describe injection procedures, with CPT code 20551
describing an injection into the tendon and CPT code 64455 describing
an injection into the plantar common digital nerve. We do not agree
that the removal of a foreign body from the eye as described in CPT
code 65210 would have such greater intensity that it warrants a work
RVU of 0.75 (to match CPT codes 20551 and 64455) despite having
approximately 40 percent less total work time.
Comment: Several commenters stated in response to the CMS comment
solicitation that the screening lane (EL006) equipment would typically
be in use for the total work time of CPT codes 65205 and 65210.
Commenters stated that the screening lane is the ophthalmic equivalent
of an exam room in the non-facility setting which would be needed for
the total time of the procedure. Commenters stated that this equipment
time represented the total time taken by the physician to perform the
service in the screening lane (which would be not be available for use
by another patient during the time of the procedure), plus the time
inputs for the technician work as listed above.
Response: We appreciate the additional information provided by the
commenters regarding the use of the screening lane (EL006) equipment.
After consideration of the public comments, we are finalizing the
work RVUs and the direct PE inputs for the codes in the Removal of
Foreign Body--Eye family of codes as proposed.
(30) Injection--Eye (CPT Codes 67500, 67505, and 67515)
CPT code 67515 (Injection of medication or other substance into
Tenon's capsule) was identified as potentially misvalued on a screen of
0-day global services reported with an E/M visit 50 percent of the time
or more, on the same day of service by the same patient and the same
practitioner, that have not been reviewed in the last 5 years with
Medicare utilization greater than 20,000. CPT codes 67500 (Retrobulbar
injection; medication (separate procedure, does not include supply of
medication)) and 67505 (Retrobulbar injection; alcohol) were also
included for review as part of the same family of codes. For CY 2019,
we proposed the RUC-recommended work RVU of 1.18 for CPT code 67500.
For CPT code 67505, we disagreed with the RUC-recommended work RVU
of 1.18 and we proposed a work RVU of 0.94 based on a direct crosswalk
to CPT code 31575 (Laryngoscopy, flexible; diagnostic). This is a
recently reviewed code with the same intraservice time of 5 minutes and
2 fewer minutes of total time as compared to CPT code 67505. We
disagreed with the recommendation to propose the same work RVU of 1.18
for both CPT code 67500 and 67505 for several reasons. We noted that
the current work RVU of 1.44 for CPT code 67500 is higher than the
current work RVU of 1.27 for CPT code 67505, while the current work
time of CPT code 67500 is less than the current work time for CPT code
67505. This supported the view that CPT code 67500 should be valued
higher than CPT code 67505 due to its greater intensity, which we also
found to be supportable on clinical grounds. The typical patient for
CPT code 67505 has already lost their sight, and there is less of a
concern about accidental blindness as compared to CPT code 67500. At
the recommended identical work RVUs, CPT code 67500 has almost triple
the intensity of CPT code 67505. Similarly, the intensity does not
match our clinical understanding of the complexity and difficulty of
the two procedures.
We also noted that the surveyed total time for CPT code 67505 was 7
minutes less than the surveyed time for CPT code 67500, approximately
21 percent lower. If we were to take the total time ratio between the
two codes, it would produce a suggested work RVU of 0.93 (26 minutes
divided by 33 minutes times a work RVU of 1.18). This time ratio
suggested a work RVU almost identical to the 0.94 value that we
determined via a crosswalk to CPT code 31575. Based on the preceding
rationale, we proposed a work RVU of 0.94 for CPT code 67505.
For CPT code 67515, we disagreed with the RUC-recommended work RVU
of 0.84 and we proposed a work RVU of 0.75 based on a crosswalk to CPT
code 64450 (Injection, anesthetic agent; other peripheral nerve or
branch). The recommended work RVU is based on a direct crosswalk to CPT
code 65222 (Removal of foreign body, external eye; corneal, with slit
lamp) at a work RVU of 0.84. However, the recommended crosswalk code
has more than double the intraservice time of CPT code 67515 at 7
minutes, and we believe that it would be more accurate to use a
crosswalk to a code with a more similar intraservice time such as CPT
code 64450, which is another type of injection procedure. The proposed
work RVU of 0.75 is also based on the use of the intraservice time
ratio with the first code in the family, CPT code 67500. The
intraservice time ratio between these codes is 0.60 (3 minutes divided
by 5 minutes), which yields a suggested work RVU of 0.71 when
multiplied by the recommended work RVU of 1.18 for CPT code 67500. We
believe that this provides further rationale for our proposed work RVU
of 0.75 for CPT code 67515.
We did not propose any direct PE refinements for this code family.
The following is a summary of the public comments we received on
our proposals involving the Injection--Eye family of codes.

[[Page 59545]]

Comment: Commenters were supportive of the CMS proposal of the RUC-
recommended work RVU of 1.18 for CPT code 67500.
Response: We appreciate the support for our proposal from the
commenters.
Comment: Many commenters disagreed with the proposed work RVU of
0.94 for CPT code 67505 and stated that CMS should finalize the RUC-
recommended work RVU of 1.18. Commenters were confused by the CMS
statement that, at the recommended identical work RVUs, CPT code 67500
has almost triple the intensity of CPT code 67505. Commenters stated
that the RUC recommendation for CPT code 67505 has less total time and
slightly higher intensity than CPT code 67500.
Response: We agree with the commenters that this was an inaccurate
statement; we intended to state that the current intensity of CPT code
67500 prior to review is almost triple the current intensity of CPT
code 67505. We regret any resulting confusion on this subject.
Comment: Several commenters disagreed with the use of a time ratio
analysis to support the CMS proposed work value. Commenters stated that
time ratios do not adequately account for intensity and complexity of
work, which can only be addressed through the survey and the RUC
process.
Response: We disagree with the commenters and continue to believe
that the use of time ratios is one of several appropriate methods for
identifying potential work RVUs for particular PFS services,
particularly when the alternative values recommended by the RUC and
other commenters do not account for information provided by surveys
that suggests the amount of time involved in furnishing the service has
changed significantly. We reiterate that, consistent with the statute,
we are required to value the work RVU based on the relative resources
involved in furnishing the service, which include time and intensity.
When our review of recommended values reveals that changes in the
resource of time have been unaccounted for in a recommended RVU, then
we believe we have the obligation to account for that change in
establishing work RVUs since the statute explicitly identifies time as
one of the two elements of the work RVUs. We recognize that it would
not be appropriate to develop work RVUs solely based on time given that
intensity is also an element of work, but in applying the time ratios,
we are using derived intensity measures based on current work RVUs for
individual procedures. Were we to disregard intensity altogether, the
work RVUs for all services would be developed based solely on time
values and that is definitively not the case, as indicated by the many
services that share the same time values but have different work RVUs.
(As an example, CPT codes 38222, 54231, 55870, 75573, and 78814 all
share identical CY 2019 work times with 15 minutes of preservice time,
30 minutes of intraservice time, and 15 minutes of postservice time;
however these codes have respective CY 2019 work RVUs of 1.44, 2.04,
2.58, 2.55, and 2.20.) Furthermore, we reiterate that we use time
ratios to identify potentially appropriate work RVUs, and then use
other methods (including estimates of work from CMS medical personnel
and crosswalks to key reference or similar codes) to validate these
RVUs. For more details on our methodology for developing work RVUs, we
direct readers to the discussion CY 2017 PFS final rule (81 FR 80272
through 80277). We also note that in the case of CPT code 65210, we
derived our proposed work RVU of 0.61 by using a direct crosswalk to
CPT code 31575 and not a time ratio.
Comment: Several commenters stated that while it was true that the
current work value for CPT code 67500 is higher than that of CPT code
67505, the survey 25th percentiles indicated that the physician work of
CPT code 67505 (work RVU = 1.30) is higher than that of CPT code 67500
(work RVU = 1.18). Commenters stated that the reason for performing
surveys is to adjust for changes in physician work that have occurred
since the prior survey, and that it was inappropriate to put more
weight on old data than on the most recent data. Commenters also
disagreed with the proposed work RVU on clinical grounds, stating that
CPT code 67505 has a higher intensity than CPT code 67500, not because
of potential vision loss, but because of the risk of death if the
absolute alcohol is injected accidentally into the optic nerve sheath.
Commenters stated that the alcohol injection involved in CPT code 67505
is typically very painful, even after a local anesthetic injection, and
carries with it the risk of death which therefore makes it a high-
intensity procedure for both patient and physician.
Response: We appreciate the additional clinical details involving
CPT code 67505 from the commenters. After reviewing the information
provided by the commenters, we are not finalizing our proposed work RVU
of 0.94 for CPT code 67505, and we are finalizing the RUC-recommended
work RVU of 1.18 instead due to the additional risks carried by the
procedure.
Comment: Many commenters disagreed with the proposed work RVU of
0.75 for CPT code 67515 and stated that CMS should finalize the RUC-
recommended work RVU of 0.84. Commenters disagreed with the CMS
crosswalk to CPT code 64450 and stated that the intensity of an
injection adjacent to the eye in which the physician is unable to see
the needle tip is clearly greater than that of an injection into a
peripheral nerve as in the code for the CMS proposed crosswalk.
Commenters stated that the use of a time ratio methodology for CPT code
67515 was particularly inappropriate due to changes in the RUC survey
methodology since the last survey for this service was performed, and
that increases in the intensity of CPT code 67515 should not be of
concern due to the 0-day global period and short intraservice work
time.
Response: We continue to believe that the use of time ratios is one
of several appropriate methods for identifying potential work RVUs, as
described in more detail in our response to the comments for CPT code
67505 above. We also disagree with the commenters on their objections
on clinical grounds concerning our crosswalk to CPT code 64450. CPT
code 64450 describes the injection of an anesthetic agent into a
peripheral nerve or branch, and the practitioner performing this
service also cannot see a needle tip when injecting into a peripheral
nerve. In other words, this is the same situation as that described in
CPT code 67515: The practitioner performing the service is unable to
see the needle tip in both cases. We continue to note that the RUC-
recommended crosswalk code (CPT code 65222) has more than double the
intraservice time of CPT code 67515 at 7 minutes, and we continue to
believe that it would be more accurate to use a crosswalk to a code
with a similar intraservice time such as CPT code 64450.
After consideration of the public comments, we are finalizing the
work RVUs for CPT codes 67500 and 67515 as proposed. We are finalizing
the RUC-recommended work RVU of 1.18 for CPT code 67505. We are also
finalizing the direct PE inputs for all three codes as proposed.
(31) X-Ray Spine (CPT Codes 72020, 72040, 72050, 72052, 72070, 72072,
72074, 72080, 72100, 72110, 72114, and 72120)
CPT codes 72020 (Radiologic examination, spine, single view,
specify level) and 72072 (Radiologic examination, spine; thoracic, 3
views) were identified on a screen of CMS or

[[Page 59546]]

Other source codes with Medicare utilization greater than 100,000
services annually. The code family was expanded to include ten
additional CPT codes to be reviewed together as a group: CPT codes
72040 (Radiologic examination, spine, cervical; 2 or 3 views), 72050
(Radiologic examination, spine, cervical; 4 or 5 views), 72052
(Radiologic examination, spine, cervical; 6 or more views), 72070
(Radiologic examination, spine; thoracic, 2 views), 72074 (Radiologic
examination, spine; thoracic, minimum of 4 views), 72080 (Radiologic
examination, spine; thoracolumbar junction, minimum of 2 views), 72100
(Radiologic examination, spine, lumbosacral; 2 or 3 views), 72110
(Radiologic examination, spine, lumbosacral; minimum of 4 views), 72114
(Radiologic examination, spine, lumbosacral; complete, including
bending views, minimum of 6 views), and 72120 (Radiologic examination,
spine, lumbosacral; bending views only, 2 or 3 views).
The radiologic examination procedures described by CPT codes 72020
(Radiologic examination, spine, single view, specify level), 72040
(Radiologic examination, spine, cervical; 2 or 3 views), 72050
(Radiologic examination, spine, cervical; 4 or 5 views), 72052
(Radiologic examination, spine, cervical; 6 or more views), 72070
(Radiologic examination, spine; thoracic, 2 views), 72072 (Radiologic
examination, spine; thoracic, 3 views), 72074 (Radiologic examination,
spine; thoracic, minimum of 4 views), 72080 (Radiologic examination,
spine; thoracolumbar junction, minimum of 2 views), 72100 (Radiologic
examination, spine, lumbosacral; 2 or 3 views), 72110 (Radiologic
examination, spine, lumbosacral; minimum of 4 views), 72114 (Radiologic
examination, spine, lumbosacral; complete, including bending views,
minimum of 6 views), 72120 (Radiologic examination, spine, lumbosacral;
bending views only, 2 or 3 views), 72200 (Radiologic examination,
sacroiliac joints; less than 3 views), 72202 (Radiologic examination,
sacroiliac joints; 3 or more views), 72220 (Radiologic examination,
sacrum and coccyx, minimum of 2 views), 73070 (Radiologic examination,
elbow; 2 views), 73080 (Radiologic examination, elbow; complete,
minimum of 3 views), 73090 (Radiologic examination; forearm, 2 views),
73650 (Radiologic examination; calcaneus, minimum of 2 views), and
73660 (Radiologic examination; toe(s), minimum of 2 views) were all
identified as potentially misvalued through a screen for CPT codes with
high utilization.
With approval from the RUC Research Subcommittee, the specialty
societies responsible for reviewing these CPT codes did not conduct
surveys, but instead employed a ``crosswalk methodology,'' in which
they derived physician work and time components for CPT codes by
comparing them to similar CPT codes. We recognize that a substantial
amount of time and effort is involved in conducting surveys of
potentially misvalued CPT codes; however, we had concerns about the
quality of the underlying data used to value these CPT codes. The
descriptors and other information on which the recommendations are
based have themselves not been surveyed, in several instances, since
1995. Without the benefit of a survey or other external source of data
about these CPT codes, there is no information that would allow us to
detect any potential improvements in efficiency of furnishing the
service or evaluate whether changes in practice patterns have affected
time and intensity. We are not categorically opposed to changes in the
RUC process or methodology that might reduce the burden of conducting
surveys, but without the benefit of any additional data, through
surveys or otherwise, we were not convinced that there was a basis for
evaluating the RUC's recommendations for work RVUs for each of these
CPT codes.
Since all 20 of the CPT codes in this group have very similar
intraservice (from 3-5 minutes) and total (ranging from 5-8 minutes)
times, we proposed to use an alternative approach to the valuation of
work RVUs for these CPT codes. We calculated the utilization-weighted
average RUC-recommended work RVU for the 20 CPT codes. The result of
this calculation was a work RVU of 0.23, which we proposed to apply
uniformly to each CPT code: 72020, 72040, 72050, 72052, 72070, 72072,
72074, 72080, 72100, 72110, 72114, 72120, 72200, 72202, 72220, 73070,
73080, 73090, 73650, and 73660. We recognized that the proposed work
RVU for some of these CPT codes might be somewhat lower at the code
level than the RUC's recommendation, while the proposed work RVU for
other CPT codes might be slightly higher than the RUC's recommended
value. We nevertheless believe that the alternative, accepting the
RUC's recommendation for each separate CPT code implied a level of
precision about the time and intensity of the CPT codes that we had no
way to validate.
For the direct PE inputs, we proposed to add a patient gown (SB026)
supply to CPT code 72120. We noted that all of the other codes in the
family that included clinical labor time for the ``Greet patient,
provide gowning, ensure appropriate medical records are available''
(CA009) task included a patient gown, and we proposed to add the
patient gown to match the other codes in the family. We believed that
the exclusion of the patient gown for CPT code 72120 was most likely
due to a clerical error in the recommendations. We also proposed to
refine the equipment time for the basic radiology room (EL012) in
accordance with our standard equipment time formulas.
In our review of the clinical labor time recommended for the
``Perform procedure/service--NOT directly related to physician work
time'' (CA021) task, we noted that the standard convention for this
family of codes seemed to be 3 minutes of clinical labor time per view
being conducted. For example, CPT code 72020 with a single view had 3
minutes of recommended clinical labor time for this activity, while CPT
code 72070 with two views had 6 minutes. However, we also noted that
for the codes with 2-3 views such as CPT codes 72040 and 72100, the
recommended clinical labor time of 9 minutes appears to assume that 3
views would always be typical for the procedure. The same pattern
occurred for codes with 4-5 views, which have a recommended clinical
labor time of 15 minutes (assuming 5 views is typical), and for codes
with 6 or more views, which have a recommended clinical labor time of
21 minutes (assuming 7 views is typical).
We did not propose to refine the clinical labor times for this task
as we did not have data available to know how many views would be
typical for these CPT codes. However, we noted that the intraservice
clinical labor time has not changed in roughly 2 decades for these X-
ray services, including during this most recent review, and we believed
that improving technology during this span of time may have resulted in
greater efficiencies in the procedures. We continue to be interested in
data sources regarding the intraservice clinical labor times for
services such as these that do not match the physician intraservice
time, and we welcomed any comments that may be able to provide
additional details for the 12 codes under review in this family.
The following is a summary of the public comments we received on
our proposals involving the X-Ray Spine family of codes.

[[Page 59547]]

Comment: A number of commenters disagreed with our proposal to
apply an identical work RVU, calculated as the utilization-weighted
average RUC-recommended work RVU for each of the 20 CPT codes, to each
of the CPT codes in this group. Commenters defended the crosswalk
methodology, stating that it is the best approach for valuing work RVUs
for codes in which the service times are very low and therefore
difficult to survey. The commenters noted that the specialty societies
have tried to survey codes such as this in the past with results that
yielded substantial inconsistencies.
Response: We share the commenters' concerns about the validity of
surveying services with very low intraservice and total time, but we
have even more substantial concerns about a methodology that introduces
no new information about the work involved in furnishing these CPT
codes and then states their accuracy to the hundredth of a work RVU.
Survey data from the specialty societies is often the only data source
available to us that reflects the experiences of a cross-section of
providers. We remind stakeholders that we welcome additional
information or data from all sources to assist us in making proposals
and finalizing values.
Comment: In response to our proposal, the RUC offered to survey
each code in the expanded family of X-ray codes to which CMS applied
the weighted average methodology and provide survey based
recommendations for CY 2020.
Response: We appreciate the recognition on the part of the RUC of
our serious concerns about the crosswalk methodology and the integrity
of the resulting RUC recommended work RVUs. We welcome the submission
of any additional data or information that would allow us to consider
these codes for review at a future time. Commenters raised concerns
that assigning a single weighted average work RVU across this broad
family of x-ray codes inadequately reflects meaningful differences
among the codes, including the number of views and the complexity of
positioning for some x-ray services. In response to commenters'
concerns, we are instead maintaining the CY 2018 work RVUs for each CPT
code as follows: Work RVU of 0.15 for CPT code 72020, 0.22 for CPT
72040, 0.31 for CPT code 72050, 0.36 for CPT code 72052, 0.22 for CPT
code 72070, 0.22 for CPT code 72072, 0.22 for CPT code 72074, 0.22 for
CPT code 72080, 0.22 for CPT code 72100, 0.31 for CPT code 72110, 0.32
for CPT code 72114, and 0.22 for CPT code 72120.
Comment: Several commenters indicated that it was inappropriate for
CMS to value the practice expense portion of the 20 CPT codes
identically because the resources required to furnish each of the
services differ in accordance with the number of X-rays or views and
other factors.
Response: We did not propose to value the practice expense portion
of these codes identically. The proposal regarding the weighted average
for these codes refers to the work component of RVUs only.
Comment: One commenter stated that they appreciated and agreed with
adding a patient gown (SB026) supply to CPT code 72120.
Response: We appreciate the support for our proposal from the
commenter.
Comment: Several commenters stated that they would like to provide
clarity on the typical number of films obtained for the X-ray spine
codes and the rationale for the number of minutes and assumed number of
views that would be typical. Commenters stated that a minimum of 3
views would be needed in order to adequately assess the cervical spine
as described by CPT code 72040. Commenters stated that the open mouth
odontoid view helps in the assessment of the atlanto-occipital joint,
and that the AP and lateral views of the vertebral bodies are required
to assess the alignment of the vertebral bodies in two planes, the disc
spaces, the spinal canal, fractures, and widening of different joints.
Commenters provided a similar level of clinical detail regarding the
typical number of views required for CPT codes 72050 and 72052.
Response: We appreciate the detailed information provided by the
commenters in response to our request for data sources regarding the
intraservice clinical labor times in those services that do not match
the physician intraservice time.
After consideration of the public comments, we are maintaining the
CY 2018 work RVUs for the codes in the X-Ray Spine family of codes. We
are finalizing the direct PE inputs for these codes as proposed.
(32) X-Ray Sacrum (CPT Codes 72200, 72202, and 72220)
CPT code 72220 (Radiologic examination, sacrum and coccyx, minimum
of 2 views) was identified on a screen of CMS or Other source codes
with Medicare utilization greater than 100,000 services annually. CPT
codes 72200 (Radiologic examination, sacroiliac joints; less than 3
views) and 72202 (Radiologic examination, sacroiliac joints; 3 or more
views) were also included for review as part of the same family of
codes. See (31) X-Ray Spine (CPT codes 72020, 72040, 72050, 72052,
72070, 72072, 72074, 72080, 72100, 72110, 72114, and 72120) for a
discussion of proposed work RVUs for these codes.
For the direct PE inputs, we proposed to refine the equipment time
for the basic radiology room (EL012) in accordance with our standard
equipment time formulas.
The following is a summary of the public comments we received on
our proposals involving the X-Ray Sacrum family of codes.
Comment: Comments regarding our proposed work RVU for this family
of codes were similar to those discussed in (31) X-Ray Spine (CPT codes
72020, 72040, 72050, 72052, 72070, 72072, 72074, 72080, 72100, 72110,
72114, and 72120).
Response: As discussed above, we are maintaining the CY 2018 work
RVUs for each code in this family as follows: Work RVU of 0.17 for CPT
code 72200, 0.19 for CPT Code 72202, and 0.17 for CPT code 72220.
Comment: One commenter stated that CMS did not indicate what amount
of service period time was removed from the calculation of the
equipment time, and that this made it difficult to determine the
accuracy of the refinements. The commenter requested more information
about this change.
Response: For the basic radiology room (EQ137) equipment, we
removed the clinical labor for the CA030 clinical labor activity in
accordance with our standard equipment time formula for highly
technical equipment.
After consideration of the public comments, we are maintaining the
CY 2018 work RVUs for the codes in the X-Ray Sacrum family of codes. We
are finalizing the direct PE inputs for these codes as proposed.
(33) X-Ray Elbow-Forearm (CPT Codes 73070, 73080, and 73090)
CPT codes 73070 (Radiologic examination, elbow; 2 views) and 73090
(Radiologic examination; forearm, 2 views) were identified on a screen
of CMS or Other source codes with Medicare utilization greater than
100,000 services annually. CPT code 73080 (Radiologic examination,
elbow; complete, minimum of 3 views) was also included for review as
part of the same family of codes. See (31) X-Ray Spine (CPT codes
72020, 72040, 72050, 72052, 72070, 72072, 72074, 72080, 72100, 72110,
72114, and 72120) above for a discussion of proposed work RVUs for
these codes.
For the direct PE inputs, we proposed to refine the equipment time
for the

[[Page 59548]]

basic radiology room (EL012) in accordance with our standard equipment
time formulas.
The following is a summary of the public comments we received on
our proposals involving the X-Ray Elbow-Forearm family of codes.
Comment: Comments regarding our proposed work RVU for this family
of codes were similar to those discussed in (31) X-Ray Spine (CPT codes
72020, 72040, 72050, 72052, 72070, 72072, 72074, 72080, 72100, 72110,
72114, and 72120).
Response: As discussed above, we are maintaining the CY 2018 work
RVUs for each code in this family as follows: Work RVU of 0.15 for CPT
code 73070, 0.17 for CPT code 73080, 0.17 for CPT code 73090.
Comment: One commenter stated that CMS did not indicate what amount
of service period time was removed from the calculation of the
equipment time, and that this made it difficult to determine the
accuracy of the refinements. The commenter requested more information
about this change.
Response: For the basic radiology room (EQ137) equipment, we
removed the clinical labor for the CA030 clinical labor activity in
accordance with our standard equipment time formula for highly
technical equipment.
After consideration of the public comments, we are maintaining the
CY 2018 work RVUs for the codes in the X-Ray Elbow-Forearm family of
codes. We are finalizing the direct PE inputs for these codes as
proposed.
(34) X-Ray Heel (CPT Code 73650)
CPT code 73650 (Radiologic examination; calcaneus, minimum of 2
views) was identified on a screen of CMS or Other source codes with
Medicare utilization greater than 100,000 services annually. See (31)
X-Ray Spine above for a discussion of proposed work RVUs for these
codes.
For the direct PE inputs, we proposed to refine the equipment time
for the basic radiology room (EL012) in accordance with our standard
equipment time formulas.
The following is a summary of the public comments we received on
our proposals involving CPT code 73650.
Comment: Comments regarding our proposed work RVU for this code
were similar to those discussed in (31) X-Ray Spine (CPT codes 72020,
72040, 72050, 72052, 72070, 72072, 72074, 72080, 72100, 72110, 72114,
and 72120).
Response: As discussed above, we are maintaining the CY 2018 work
RVU of 0.16 for CPT code 73650.
Comment: One commenter stated that CMS did not indicate what amount
of service period time was removed from the calculation of the
equipment time, and that this made it difficult to determine the
accuracy of the refinements. The commenter requested more information
about this change.
Response: For the basic radiology room (EQ137) equipment, we
removed the clinical labor for the CA030 clinical labor activity in
accordance with our standard equipment time formula for highly
technical equipment.
After consideration of the public comments, we are maintaining the
CY 2018 work RVUs for the codes in the X-Ray Heel family of codes. We
are finalizing the direct PE inputs for these codes as proposed.
(35) X-Ray Toe (CPT Code 73660)
CPT code 73660 (Radiologic examination; toe(s), minimum of 2 views)
was identified on a screen of CMS or Other source codes with Medicare
utilization greater than 100,000 services annually. See (31) X-Ray
Spine above for a discussion of proposed work RVUs for these codes.
For the direct PE inputs, we proposed to add a patient gown (SB026)
supply to CPT code 73660. We noted that the other codes in related X-
ray code families that included clinical labor time for the ``Greet
patient, provide gowning, ensure appropriate medical records are
available'' (CA009) task included a patient gown, and we proposed to
add the patient gown to match the other codes in these families. We
also proposed to refine the equipment time for the basic radiology room
(EL012) in accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on
our proposals involving CPT code 73660.
Comment: Comments regarding our proposed work RVU for this code
were similar to those discussed in (31) X-Ray Spine (CPT codes 72020,
72040, 72050, 72052, 72070, 72072, 72074, 72080, 72100, 72110, 72114,
and 72120).
Response: As discussed above, we are maintaining the CY 2018 work
RVU of 0.13 for CPT code 73660.
Comment: Several commenters stated that the typical patient for
this service would not require a patient gown. Commenters stated that
this was different than other codes in the family where the patient may
need to be rotated lateral and prone for different views.
Response: We appreciate the feedback from the commenters. In light
of the information supplied by commenters, we will not finalize our
proposal to add a patient gown (SB026) supply to CPT code 73660.
Comment: One commenter stated that CMS did not indicate what amount
of service period time was removed from the calculation of the
equipment time, and that this made it difficult to determine the
accuracy of the refinements. The commenter requested more information
about this change.
Response: For the basic radiology room (EQ137) equipment, we
removed the clinical labor for the CA030 clinical labor activity in
accordance with our standard equipment time formula for highly
technical equipment.
After consideration of the public comments, we are maintaining the
CY 2018 work RVUs for the codes in the X-Ray Toe family of codes. We
are finalizing the direct PE inputs as proposed with the exception of
the patient gown (SB026) supply as detailed above.
(36) X-Ray Esophagus (CPT Codes 74210, 74220, and 74230)
CPT code 74220 (Radiologic examination; esophagus) was identified
on a screen of CMS or Other source codes with Medicare utilization
greater than 100,000 services annually. CPT codes 74210 (Radiologic
examination; pharynx and/or cervical esophagus) and 74230 (Swallowing
function, with cineradiography/videoradiography) were also included for
review as part of the same family of codes.
We proposed the work RVUs recommended by the RUC for the CPT codes
in this family as follows: A work RVU 0.59 for CPT code 74210
(Radiologic examination; pharynx and/or cervical esophagus), a work RVU
of 0.67 for CPT code 74220 (Radiologic examination; esophagus), and a
work RVU of 0.53 for CPT code 74230 (Swallowing function, with
cineradiography/videoradiography).
For the direct PE inputs, we noted that the recommended quantity of
the Polibar barium suspension (SH016) supply is increasing from 1 ml to
150 ml for CPT code 74210 and 100 ml are being added to CPT code 74220,
which did not previously include this supply. The RUC recommendation
states that this supply quantity increase is due to clinical necessity,
but does not go into further details about the typical use of the
supply. Although we did not propose to refine the quantity of the
Polibar barium suspension at this time, we solicited additional comment
about the typical use of the supply in these procedures. We also
proposed to refine the equipment times for all three codes in
accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on
our

[[Page 59549]]

proposals involving the X-Ray Esophagus family of codes.
Comment: We received no specific comments regarding our proposals
for work RVUs in this family.
Response: As a result, we are finalizing a work RVU of 0.59 for CPT
code 74210, a work RVU of 0.67 for CPT code 74220, and a work RVU of
0.53 for CPT code 74230 as proposed.
Comment: Several commenters responded to the comment solicitation
about the typical use of the Polibar barium suspension (SH016) supply
in these procedures. Commenters stated that the barium suspension
quantity listed for CPT code 74210 prior to review was only 1 ml which
appeared to be a technical error in mistaking number of milliliters for
number of items, as this was an insufficient quantity of barium for the
procedure. Commenters stated that CPT code 74220 did not have barium
suspension listed as a supply item, which appeared to be an oversight.
The commenters described how the patient swallows a small quantity of
high density barium to outline the esophagus, followed by multiple
subsequent swallows of normal density barium that are assessed under
fluoroscopy from different angles to evaluate the esophageal anatomy
and mucosa.
Response: We appreciate the additional details provided by the
commenters regarding the use of the Polibar barium suspension (SH016)
supply, and the clarification that the previous supply quantities in
these procedures appear to have been in error.
After consideration of the public comments, we are finalizing the
work RVU and the direct PE inputs for the codes in the X-Ray Esophagus
family of codes as proposed.
(37) X-Ray Urinary Tract (CPT Code 74420)
CPT code 74420 (Urography, retrograde, with or without KUB) was
identified on a screen of CMS or Other source codes with Medicare
utilization greater than 100,000 services annually. We proposed the
RUC-recommended work RVU of 0.52 for CPT code 74420 (Urography,
retrograde, with or without KUB).
For the direct PE inputs, we proposed to remove the 1 minute of
clinical labor time for the ``Confirm order, protocol exam'' (CA014)
activity. The clinical labor time recommended for this activity is not
included in the reference code, nor is it included in any of the two
dozen other X-ray codes that were reviewed at the same RUC meeting.
There is also no explanation in the recommended materials as to why
this clinical labor time would need to be added. We do not believe that
this clinical labor would be typical for CPT code 74420, and we
proposed to remove it to match the rest of the X-ray codes. We also
proposed to refine the equipment times in accordance with our standard
equipment time formulas.
The following is a summary of the public comments we received on
our proposals involving CPT code 74420.
Comment: We received no specific comments regarding our proposal
for the work RVU for CPT code 74420.
Response: We are finalizing a work RVU of 0.52 for CPT code 74420.
Comment: Several commenters disagreed with the proposal to remove
the 1 minute of clinical labor time for the ``Confirm order, protocol
exam'' (CA014) activity. The commenters stated that this service was
distinct from the other X-ray services reviewed during this cycle and
encouraged CMS to modify this proposal by finalizing the RUC-
recommended direct PE inputs for clinical labor.
Response: We addressed this subject in detail in the PE section of
this final rule under the Changes to Direct PE Inputs for Specific
Services heading (section II.B.3. of this final rule). For CPT code
74420, we are finalizing these clinical labor refinements as proposed
as there is no clinical labor assigned to the ``Review patient clinical
extant information and questionnaire'' (CA007) activity. We also note
that commenters did not provide a rationale as to what made CPT code
74420 distinct from the other X-ray services reviewed during this cycle
and would justify this additional clinical labor time.
After consideration of the public comments, we are finalizing the
work RVU and the direct PE inputs for CPT code 74420 as proposed.
(38) Fluoroscopy (CPT Code 76000)
CPT code 76000 (Fluoroscopy (separate procedure), up to 1 hour
physician or other qualified health care professional time) was
identified on a screen of CMS or Other source codes with Medicare
utilization greater than 100,000 services annually. CPT code 76001
(Fluoroscopy, physician or other qualified health care professional
time more than 1 hour, assisting a nonradiologic physician or other
qualified health care professional) was also included for review as
part of the same family of codes. However, due to the fact that
supervision and interpretation services have been increasingly bundled
into the underlying procedure codes, the RUC concluded that this
practice is rare, if not obsolete, and CPT code 76001 was recommended
for deletion by the CPT Editorial Panel for CY 2019.
We proposed the RUC-recommended work RVU of 0.30 for CPT code 76000
(Fluoroscopy (separate procedure), up to 1 hour physician or other
qualified health care professional time, other than 71023 or 71034
(e.g., cardiac fluoroscopy)). For the direct PE inputs, we proposed to
refine the equipment times in accordance with our standard equipment
time formulas.
We did not receive specific comments regarding our proposals for
CPT code 76000. We are finalizing a work RVU of 0.30 and the direct PE
inputs for CPT code 76000 as proposed.
(39) Echo Exam of Eye Thickness (CPT Code 76514)
CPT code 76514 (Ophthalmic ultrasound, diagnostic; corneal
pachymetry, unilateral or bilateral (determination of corneal
thickness)) was identified as potentially misvalued on a screen of
codes with a negative intraservice work per unit of time (IWPUT), with
2016 estimated Medicare utilization over 10,000 for RUC reviewed codes
and over 1,000 for Harvard-valued and CMS/Other source codes.
For CPT code 76514, we disagreed with the RUC-recommended work RVU
of 0.17 and we proposed a work RVU of 0.14. We noted that the
recommended intraservice time for CPT code 76514 is decreasing from 5
minutes to 3 minutes (40 percent reduction), and the recommended total
time for CPT code 76514 is decreasing from 15 minutes to 5 minutes (67
percent reduction); however, the RUC-recommended work RVU is not
decreasing at all and remains at 0.17. Although we did not imply that
the decrease in time as reflected in survey values must equate to a
one-to-one or linear decrease in the valuation of work RVUs, we believe
that since the two components of work are time and intensity,
significant decreases in time should be reflected in decreases to work
RVUs.
We also noted that the RUC recommendations for CPT code 76514
stated that, although the steps in the procedure are unchanged since it
was first valued, the workflow has changed. With the advent of smaller
and easier to use pachymeters, the technician now typically takes the
measurements that used to be taken by the practitioner for CPT code
76514, and the intraservice time was reduced by two minutes to account
for the technician performing this service. We believe that this change
in workflow indicates that the work RVU for the code should be reduced
in some fashion, since some of the work

[[Page 59550]]

that was previously done by the practitioner is now typically performed
by the technician. We have no reason to believe that there is more
intensive cognitive work being performed by the practitioner after
these measurements are taken since the recommendations indicated that
the steps in the procedure are unchanged since this code was first
valued.
Therefore, we proposed a work RVU of 0.14 for CPT code 76514, which
is based on taking half of the intraservice time ratio. We considered
applying the intraservice time ratio to CPT code 76514, which would
reduce the work RVU to 0.10 based on taking the change in intraservice
time (from 5 minutes to 3 minutes) and multiplying this ratio of 0.60
times the current work RVU of 0.17. However, we recognized that the
minutes shifted to the clinical staff were less intense than the
minutes that remained in CPT code 76514, and therefore, we applied half
of the intraservice time ratio for a reduction of 0.03 RVUs to arrive
at a proposed work RVU of 0.14. We believe that this proposed value
more accurately takes into account the changes in workflow that have
caused substantial reductions in the surveyed work time for the
procedure.
We did not propose any direct PE refinements for this code family.
The following is a summary of the public comments we received on
our proposals involving CPT code 76514.
Comment: Many commenters disagreed with the proposed work RVU of
0.14 for CPT code 76514 and stated that CMS should finalize the RUC-
recommended work RVU of 0.17. Commenters stated that using an approach
that takes a fraction of the intraservice time ratio in lieu of strong
crosswalks and input from the RUC and physicians providing these
services is unfounded. Commenters restated the key reference codes
chosen by the survey participants and urged CMS to use survey data and
supportive relative reference services when valuing services.
Response: We disagree with the commenters and continue to believe
that the use of time ratios is one of several appropriate methods for
identifying potential work RVUs for particular PFS services,
particularly when the alternative values recommended by the RUC and
other commenters do not account for information provided by surveys
that suggests the amount of time involved in furnishing the service has
changed significantly. We reiterate that, consistent with the statute,
we are required to value the work RVU based on the relative resources
involved in furnishing the service, which include time and intensity.
When our review of recommended values reveals that changes in the
resource of time have been unaccounted for in a recommended RVU, then
we believe we have the obligation to account for that change in
establishing work RVUs since the statute explicitly identifies time as
one of the two elements of the work RVUs. We recognize that it would
not be appropriate to develop work RVUs solely based on time given that
intensity is also an element of work, but in applying the time ratios,
we are using derived intensity measures based on current work RVUs for
individual procedures. Were we to disregard intensity altogether, the
work RVUs for all services would be developed based solely on time
values and that is definitively not the case, as indicated by the many
services that share the same time values but have different work RVUs.
(As an example, CPT codes 38222, 54231, 55870, 75573, and 78814 all
share identical CY 2019 work times with 15 minutes of preservice time,
30 minutes of intraservice time, and 15 minutes of postservice time;
however these codes have respective CY 2019 work RVUs of 1.44, 2.04,
2.58, 2.55, and 2.20.) Furthermore, we reiterate that we use time
ratios to identify potentially appropriate work RVUs, and then use
other methods (including estimates of work from CMS medical personnel
and crosswalks to key reference or similar codes) to validate these
RVUs. For more details on our methodology for developing work RVUs, we
direct readers to the discussion CY 2017 PFS final rule (81 FR 80272
through 80277). We also note that in the case of CPT code 76514, we
recognized that the minutes shifted to the clinical staff were less
intense than the minutes that remained in CPT code 76514, and
therefore, we applied only half of the intraservice time ratio instead
of the full ratio.
Comment: Several commenters stated that while it is true that
changes in workflow as a result of smaller, portable, easier to use
pachymeters now mean that the technician typically takes the
measurements that used to be taken by the physician, the remaining 3
minutes of intraservice work time reflect the more intense cognitive
work performed by the physician after the measurements are taken.
Commenters agreed that the procedure has not fundamentally changed and
that maintaining a work RVU of 0.17 was warranted.
Response: We disagree with the commenters and continue to believe
that CPT code 76514 does not require more intensive cognitive work
being performed by the practitioner after these measurements are taken,
since the recommendations indicated that the steps in the procedure are
unchanged since this code was first valued. While the incorporation of
new technology can sometimes make services more complex and difficult
to perform, it can also have the opposite effect by making services
less reliant on manual skill and technique, and we believe that for CPT
code 76514 the latter case is true since the same work previously
carried out by the practitioner is now being carried out by the
technician.
After consideration of the public comments, we are finalizing the
work RVU and the direct PE inputs for CPT code 76514 as proposed.
(40) Ultrasound Elastography (CPT Codes 76981, 76982, and 76983)
In September 2017, the CPT Editorial Panel created three new codes
describing the use of ultrasound elastography to assess organ
parenchyma and focal lesions: CPT codes 76981 (Ultrasound,
elastography; parenchyma), 76982 (Ultrasound, elastography; first
target lesion) and 76983 (Ultrasound, elastography; each additional
target lesion). The most common use of this code set will be for
preparing patients with disease of solid organs, like the liver, or
lesions within solid organs.
The RUC recommended a work RVU of 0.59 for CPT code 76981
(Ultrasound, elastography; parenchyma (e.g., organ)), a work RVU of
0.59 for CPT code 76982 (Ultrasound, elastography; first target
lesion), and a work RVU of 0.50 for add-on CPT code 76983 (Ultrasound,
elastography; each additional target lesion). We are proposing the RUC-
recommended work RVUs for each of these new CPT codes.
For the direct PE inputs, we proposed to refine the clinical labor
time for the ``Prepare room, equipment and supplies'' (CA013) activity
to 3 minutes and to refine the clinical labor time for the ``Confirm
order, protocol exam'' (CA014) activity to 0 minutes for CPT codes
76981 and 76982. CPT code 76700 (Ultrasound, abdominal, real time with
image documentation; complete), the reference code for these two new
codes, did not previously have clinical labor time assigned for the
``Confirm order, protocol exam'' clinical labor task, and we do not
have any reason to believe that these particular services being
furnished by the clinical staff have changed in the new codes, only the
way in which this clinical labor time has been presented on the PE

[[Page 59551]]

worksheets. We also noted that there is no effect on the total clinical
labor direct costs in these situations, since the same 3 minutes of
clinical labor time is still being furnished in CPT codes 76981 and
76982. We also proposed to refine the equipment times in accordance
with our standard equipment time formulas.
The following is a summary of the public comments we received on
our proposals involving the Ultrasound Elastography family of codes.
Comment: Several commenters expressed support for our proposed work
RVUs for each of the three CPT codes in this family.
Response: We appreciate the support of commenters.
Comment: A commenter stated that in the CMS refinements to the
direct PE inputs for CPT codes 76981 and 76982, CMS proposed to remove
1 minute from the CA014 activity code and proposed to add 1 minute to
the CA013 activity code. The commenter stated that this refinement was
inaccurate and encouraged CMS to modify this proposal by finalizing the
RUC-recommended direct PE inputs for clinical labor.
Response: We addressed this subject in detail in the PE section of
this final rule under the Changes to Direct PE Inputs for Specific
Services heading (section II.B.3. of this final rule). For CPT codes
76981 and 76982, we are not finalizing these clinical labor refinements
as proposed, as these codes have the ``Patient clinical information and
questionnaire reviewed by technologist, order from physician confirmed
and exam protocoled by radiologist'' task in predecessor CPT code 76700
on the old PE worksheet as well as 1 minutes of CA007 clinical labor
time. We are instead finalizing the RUC-recommended clinical labor
times for CA013 and CA014 for CPT codes 76981 and 76982. We are also
not finalizing our refinements to the corresponding equipment times as
a result.
After consideration of the public comments, we are finalizing the
work RVUs for the codes in the Ultrasound Elastography family of codes
as proposed: 0.59 work RVUs for CPT code 76981, 0.59 work RVUs for CPT
code 76982, and 0.50 work RVUs for CPT code 76983. We are not
finalizing our proposed direct PE inputs and are instead finalizing the
RUC-recommended direct PE inputs for these three codes.
(41) Ultrasound Exam--Scrotum (CPT Code 76870)
CPT code 76870 (Ultrasound, scrotum and contents) was identified on
a screen of CMS or Other source codes with Medicare utilization greater
than 100,000 services annually. We proposed a work RVU of 0.64 for CPT
code 76870 (Ultrasound, scrotum and contents), as recommended by the
RUC.
For the direct PE inputs, we proposed to refine the clinical labor
time for the ``Prepare room, equipment and supplies'' (CA013) activity
to 3 minutes and to refine the clinical labor time for the ``Confirm
order, protocol exam'' (CA014) activity to 0 minutes. CPT code 76870
did not previously have clinical labor time assigned for the ``Confirm
order, protocol exam'' clinical labor task, and we did not have any
reason to believe that the services being furnished by the clinical
staff have changed, only the way in which this clinical labor time has
been presented on the PE worksheets. We also noted that there was no
effect on the total clinical labor direct costs in these situations
since the same 3 minutes of clinical labor time is still being
furnished under the CA013 room preparation activity. We also proposed
to refine the equipment times in accordance with our standard equipment
time formulas.
The following is a summary of the public comments we received on
our proposals involving CPT code 76870.
Comment: We received general support from commenters for our
proposed work RVU of 0.64 for CPT code 76870, as recommended by the
RUC.
Response: We thank commenters for their support.
Comment: A commenter stated that in the CMS refinements to the
direct PE inputs for CPT code 76870, CMS proposed to remove 1 minute
from the CA014 activity code and proposed to add 1 minute to the CA013
activity code. The commenter stated that this refinement was inaccurate
and encouraged CMS to modify this proposal by finalizing the RUC-
recommended direct PE inputs for clinical labor.
Response: We addressed this subject in detail in the PE section of
this final rule under the Changes to Direct PE Inputs for Specific
Services heading (section II.B.3. of this final rule). For CPT code
76870, we are finalizing these clinical labor refinements as proposed.
After consideration of the public comments, we are finalizing the
work RVU of 0.64 and direct PE inputs for CPT code 76870 as proposed.
(42) Contrast-Enhanced Ultrasound (CPT Codes 76978 and 76979)
In September 2017, the CPT Editorial Panel created two new CPT
codes describing the use of intravenous microbubble agents to evaluate
suspicious lesions by ultrasound. CPT code 76978 (Ultrasound, targeted
dynamic microbubble sonographic contrast characterization (non-
cardiac); initial lesion) is a stand-alone procedure for the evaluation
of a single target lesion. CPT code 76979 (Ultrasound, targeted dynamic
microbubble sonographic contrast characterization (non-cardiac); each
additional lesion with separate injection) is an add-on code for the
evaluation of each additional lesion.
The two new CPT codes in this family represent a new technology
that involves the use of intravenous microbubble agents to evaluate
suspicious lesions by ultrasound. The first new CPT code 76978
(Ultrasound, targeted dynamic microbubble sonographic contrast
characterization (non-cardiac); initial lesion), is the base code for
the new add-on CPT code 76979 (Ultrasound, targeted dynamic microbubble
sonographic contrast characterization (non-cardiac); each additional
lesion with separate injection). The RUC reviewed the survey results
for CPT code 76978 and recommended total time of 30 minutes and
intraservice time of 20 minutes. Their recommendation for a work RVU of
1.62 is based neither on the median of the survey results (1.82) nor
the 25th percentile of the survey results (1.27). Instead, the RUC-
recommended work RVU is based on a crosswalk to CPT code 73719
(Magnetic resonance (e.g., proton) imaging, lower extremity other than
joint; with contrast material(s)), which has identical intraservice and
total times as the survey CPT code. The RUC also identified a
comparison CPT code (CPT code 73222 (Magnetic resonance (e.g., proton)
imaging, any joint of upper extremity; with contrast material(s)) with
work RVU 1.62 and similar times. For add-on CPT code 76979, the RUC
recommended a work RVU of 0.85, which is the 25th percentile of survey
results, with total and intraservice times of 15 minutes.
Although we generally agree that, particularly in instances where a
CPT code represents a new technology or procedure, there may be reason
to deviate from survey metrics, we are confused by the logic behind the
RUC's recommendation of a work RVU of 1.62 for CPT code 76978. When we
considered the range of existing CPT codes with 30 minutes total time
and 20 minutes intraservice time, we noted that a work RVU of 1.62 is
among the highest potential crosswalks. We also noted that the RUC
agreed with the 25th percentile of survey results for the new add-on
CPT code, 76979, and we did not see

[[Page 59552]]

why the 25th percentile would not also be appropriate for the base CPT
code, 76978. Therefore, we proposed a work RVU of 1.27 for CPT code
76978. We identified two CPT codes with total time of 30 minutes and
intraservice time of 20 minutes that bracket the proposed work RVU of
1.27: CPT code 93975 (Duplex scan of arterial inflow and venous outflow
of abdominal, pelvic, scrotal contents and/or retroperitoneal organs;
complete study) has a work RVU of 1.16, and CPT code 72270
(Myelography, 2 or more regions (e.g., lumbar/thoracic, cervical/
thoracic, lumbar/cervical, lumbar/thoracic/cervical), radiological
supervision and interpretation) has a work RVU of 1.33. We proposed the
RUC-recommended work RVU of 0.85 for add-on CPT code 76979.
For the direct PE inputs, we proposed to refine the clinical labor
time for the ``Prepare room, equipment and supplies'' (CA013) activity
to 3 minutes and to refine the clinical labor time for the ``Confirm
order, protocol exam'' (CA014) activity to 0 minutes for CPT code
76978. CPT codes 76700 (Ultrasound, abdominal, real time with image
documentation; complete) and 76705 (Ultrasound, abdominal, real time
with image documentation; limited), the reference codes for this new
code, did not previously have clinical labor time assigned for the
``Confirm order, protocol exam'' clinical labor task, and we did not
have any reason to believe that these particular services being
furnished by the clinical staff have changed in the new code, only the
way in which this clinical labor time has been presented on the PE
worksheets. We also noted that there is no effect on the total clinical
labor direct costs in these situations, since the same 3 minutes of
clinical labor time is still being furnished in CPT code 76978.
We proposed to remove the 50 ml of the phosphate buffered saline
(SL180) for CPT codes 76978 and 76979. When these codes were reviewed
by the RUC, the conclusion that was reached was to remove this supply
and replace it with normal saline. Since the phosphate buffered saline
remained in the recommended direct PE inputs, we believe its inclusion
may have been a clerical error. We proposed to remove the supply and
solicited comments on the phosphate buffered saline or a replacement
saline solution. We also proposed to refine the equipment times in
accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on
our proposals involving the Contrast-Enhanced Ultrasound family of
codes.
Comment: Commenters were supportive of our proposed work RVU of
0.85 for CPT code 76979, as recommended by the RUC.
Response: We thank the commenters for their support of our proposal
regarding the work RVU for this CPT code.
Comment: A few commenters expressed opposition to our proposed work
RVU of 1.27 for new CPT code 76978. Commenters acknowledged that the
code is valued at the high end of the range of values for a given
intraservice time. However, they stated, being on the high end of a
range of comparison codes is not necessarily in itself a reason to
reduce the work RVU. They cite this as an illustration of CMS's
discounting the importance of intensity in valuing physician services
in favor of considering only time. The same commenters also noted that
the new technology used in furnishing the service, Contrast Enhanced
Ultrasound (CEUS), requires more technical skill and time than other
established ultrasound services.
Response: Our observation that a survey code is on the high end of
codes on the PFS with similar intraservice and total times is only one
among several factors we consider when we perceive that the code is not
properly valued in relation to other similar codes. We agree that there
are instances in which valuing a code at the high range of work RVUs
for codes with similar times is appropriate. However, on the whole, if
a recommended work RVU places the code on the very high end of work
RVUs with similar time parameters, we expect that the code would be of
notably higher intensity than most other codes with those time
parameters. We were not convinced that this was the case with CPT code
76978.
We were, however, persuaded by commenters that the higher technical
skill and time involved in using the new technology, CEUS, compared
with other established ultrasound services, is better reflected by the
RUC's recommended work RVU than our proposed value. Consequently we are
finalizing the RUC-recommended work RVU of 1.62 for CPT code 76978.
Comment: A commenter stated that in the CMS refinements to the
direct PE inputs for CPT code 76978, CMS proposed to remove 1 minute
from the CA014 activity code and proposed to add 1 minute to the CA013
activity code. The commenter stated that this refinement was inaccurate
and encouraged CMS to modify this proposal by finalizing the RUC-
recommended direct PE inputs for clinical labor.
Response: We addressed this subject in detail in the PE section of
this final rule under the Changes to Direct PE Inputs for Specific
Services heading (section II.B.3. of this final rule). For CPT code
76978, we are not finalizing these clinical labor refinements as
proposed, as this code has the ``Patient clinical information and
questionnaire reviewed by technologist, order from physician confirmed
and exam protocoled by radiologist'' task in predecessor CPT code 76700
on the old PE worksheet as well as 1 minutes of CA007 clinical labor
time. We are therefore finalizing the RUC-recommended clinical labor
times for CA013 and CA014 for CPT code 76978. We are also not
finalizing our refinements to the corresponding equipment times as a
result.
Comment: Several commenters disagreed with the proposal to remove
the 50 ml of the phosphate buffered saline (SL180) for CPT codes 76978
and 76979. Commenters stated that the SL180 supply can be replaced with
``normal saline'', however the change was not made because an
appropriate replacement could not be identified. Commenters stated that
the SL180 phosphate buffered saline (PBS) had been removed but ``normal
saline'' has not replaced it. Commenters agreed that this change was
appropriate and urged CMS to add the correct supply item for the
appropriate type of saline.
Response: We disagree with the commenters that the ``normal
saline'' was not added to these procedures. Both of these CPT codes
include the ``sodium chloride 0.9% inj bacteriostatic (30ml uou)''
(SH068) supply which would function as a form of normal saline. We do
not believe that it would be typical for these procedures to contain 50
ml of the phosphate buffered saline (SL180) in addition to the ``normal
saline'' described by the SH068 supply.
After consideration of the public comments, we are finalizing the
RUC-recommended work RVUs for both codes in this family as follows:
Work RVU of 0.85 for CPT code 76979 and a work RVU of 1.62 for CPT code
76978. We are also finalizing the RUC-recommended direct PE inputs for
these codes, with the exception of the refinement to the phosphate
buffered saline (SL180) supply as detailed above.
(43) Magnetic Resonance Elastography (CPT Code 76391)
The CPT Editorial Panel created new stand-alone CPT code 76391
describing the use of magnetic resonance elastography for the
evaluation of organ parenchymal pathology. This code will most often be
used to evaluate patients

[[Page 59553]]

with disease of solid organs (for example, cirrhosis of the liver) or
pathology within solid organs that manifest with increasing fibrosis or
scarring. The goal with magnetic resonance elastography is to evaluate
the degree of fibrosis/scarring (that is, stiffness) without having to
perform more invasive procedures (for example, biopsy). This technique
can be used to characterize the severity of parenchymal disease, follow
disease progression, or response to therapy.
The RUC recommended a work RVU for new CPT code 76391 (Magnetic
resonance (e.g., vibration) elastography) of 1.29, with 15 minutes of
intraservice time and 25 minutes of total time. The recommendation is
based on a comparison with two reference CPT codes, CPT code 74183
(Magnetic resonance (e.g., proton) imaging, abdomen; without contrast
material(s), followed by with contrast material(s) and further
sequences) with total time of 40 minutes, intraservice time of 30
minutes, and a work RVU of 2.20; and CPT code 74181 (Magnetic resonance
(e.g., proton) imaging, abdomen; without contrast material(s)), which
has a total time of 30 minutes, intraservice time of 20 minutes, and a
work RVU of 1.46. The RUC stated that both reference CPT codes have
higher work values than the new CPT code, which is justified in both
cases by higher intra-service times. They noted that, despite shorter
intraservice and total time, CPT code 76391 is slightly more intense to
perform due to the evaluation of wave propagation images and
quantitative stiffness measures. We did not agree with the RUC's
recommended work RVU for this CPT code. Using the RUC's two top
reference CPT codes as a point of comparison, the intraservice time
ratio in both instances suggests that a work RVU closer to 1.10 would
be more appropriate. We recognize that the RUC believes the new CPT
code is slightly more intense to furnish, but we are concerned about
the relativity of this code in comparison with other imaging procedures
that have similar intraservice and total times. Instead of the RUC-
recommended work RVU of 1.29 for CPT code 76391, we proposed a work RVU
of 1.10, which is based on a direct crosswalk to CPT code 71250
(Computed tomography, thorax; without contrast material). CPT code
71250 has identical intraservice time (15 minutes) and total time (25
minutes) compared to CPT code 76391, and we believe that the work
involved in furnishing both services is similar. We note that CPT code
76391 describes a new technology and will be reviewed again by the RUC
in 3 years.
For the direct PE inputs, we proposed to refine the clinical labor
time for the ``Prepare room, equipment and supplies'' (CA013) activity
from 6 minutes to 5 minutes, and for the ``Prepare, set-up and start
IV, initial positioning and monitoring of patient'' (CA016) activity
from 4 minutes to 3 minutes. We disagreed that this additional clinical
labor time would be typical for these activities, which are already
above the standard times for these tasks. In both cases, we proposed to
maintain the current time from the reference CPT code 72195 (Magnetic
resonance (e.g., proton) imaging, pelvis; without contrast material(s))
for these clinical labor activities. We also proposed to refine the
equipment times in accordance with our standard equipment time
formulas.
The following is a summary of the public comments we received on
our proposals involving CPT code 76391.
Comment: A commenter stated that CMS misunderstood the role of
reference CPT codes in the RUC's valuation process, and therefore our
proposed work RVU for CPT code 76391 is premised on a false time
comparison and a methodology that is invalid.
Response: In the materials provided to us, the RUC explicitly
compared the two key reference services to CPT 76391 and stated that
the higher work values for these codes are justified by higher
intraservice times. The RUC did not provide a crosswalk code for CPT
76391. Because of the RUC's justification of the higher work RVUs in
the reference services in relation to the higher intraservice times for
these codes, and because the RUC did not provide a crosswalk CPT code
for us to review, we believe it is an entirely appropriate methodology
to calculate the intraservice time ratios using those reference codes.
We acknowledged that the survey code is slightly more intense to
perform than the reference codes, according to the RUC's SOR, which is
why our calculation of intraservice time ratios is only a starting
point in our review of the code's recommended work RVU. We considered
the intraservice time ratios for both reference codes, which were not
identical, and compared these values to other CPT codes in the PFS with
similar intraservice and total times. For this particular CPT code
76391, we identified a crosswalk to CPT code 71250, which, as we
stated, achieved an overall balance of similar times and similar
intensity as the survey code and has a work RVU of 1.10.
Comment: Some commenters stated that our proposed value of 1.10
work RVUs for CPT code 76391 creates a rank order anomaly between an
MRI code and CPT code, CPT code 74160.
Response: We do not agree that our proposed work RVU of 1.10 for
this code creates a rank order anomaly between an MRI code and CT code
because this service is described as being unlike a routine magnetic
resonance imaging. This service also involves use of a new technology,
which makes it difficult to compare directly to services involving
magnetic resonance imaging. We are finalizing a work RVU of 1.10 for
CPT code 76391.
Comment: One commenter agreed with the refinements to the direct PE
inputs.
Response: We appreciate the support for our proposals from the
commenter.
After consideration of the public comments, we are finalizing the
work RVU of 1.10 and the direct PE inputs for CPT code 76391 as
proposed.
(44) Computed Tomography (CT) Scan for Needle Biopsy (CPT Code 77012)
CPT code 77012 (Computed tomography guidance for needle placement
(e.g., biopsy, aspiration, injection, localization device),
radiological supervision and interpretation) was identified on a screen
of CMS or Other source codes with Medicare utilization greater than
100,000 services annually.
We proposed the RUC-recommended work RVU of 1.50 for CPT code 77012
(Computed tomography guidance for needle placement (e.g., biopsy,
aspiration, injection, localization device), radiological supervision
and interpretation).
For the direct PE inputs, we proposed to refine the clinical labor
time for the ``Prepare room, equipment and supplies'' (CA013) activity
to 3 minutes and to refine the clinical labor time for the ``Confirm
order, protocol exam'' (CA014) activity to 0 minutes. CPT code 77012
did not previously have clinical labor time assigned for the ``Confirm
order, protocol exam'' clinical labor task, and we did not have any
reason to believe that the services being furnished by the clinical
staff have changed, only the way in which this clinical labor time has
been presented on the PE worksheets. We also noted that there is no
effect on the total clinical labor direct costs in these situations
since the same 3 minutes of clinical labor time is still being
furnished under the CA013 room preparation activity.
We proposed to refine the equipment time for the CT room (EL007) to
maintain the current time of 9 minutes. CPT code 77012 is a
radiological supervision and interpretation

[[Page 59554]]

procedure and there has been a longstanding convention in the direct PE
inputs, shared by 38 other codes, to assign an equipment time of 9
minutes for the equipment room in these procedures. We do not believe
that it would serve the interests of relativity to increase the
equipment time for the CT room in CPT code 77012 without also
addressing the equipment room time for the other radiological
supervision and interpretation procedures. Therefore, we proposed to
maintain the current equipment room time of 9 minutes until this group
of procedures can be subject to a more comprehensive review. We also
proposed to refine the equipment time for the Technologist PACS
workstation (ED050) in accordance with our standard equipment time
formulas.
The following is a summary of the public comments we received on
our proposals involving CPT code 77012.
Comment: We received support from a few commenters for our proposed
work RVU for CPT code 77012, as recommended by the RUC.
Response: We appreciate commenters' support. We are finalizing a
work RVU of 1.50 for CPT code 77012.
Comment: A commenter stated that in the CMS refinements to the
direct PE inputs for CPT code 77012 CMS proposed to remove 1 minute
from the CA014 activity code and proposed to add 1 minute to the CA013
activity code. The commenter stated that this refinement was inaccurate
and encouraged CMS to modify this proposal by finalizing the RUC-
recommended direct PE inputs for clinical labor.
Response: We addressed this subject in detail in the PE section of
this final rule under the Changes to Direct PE Inputs for Specific
Services heading (section II.B.3. of this final rule). For CPT code
77012, we are finalizing these clinical labor refinements as proposed.
Comment: Several commenters disagreed with the proposal to refine
the equipment time for the CT room (EL007) to maintain the current time
of 9 minutes. Commenters stated that the room time is included in CT
guidance, as it is in US guidance (such as in CPT code 76942) because
that is the room the procedure is performed in. Commenters stated that
they agreed with CMS that other RS&I codes use the 9 minutes for room
time as a precedent, but this was specific to angiographic rooms and
referred to language from 2013 regarding angiographic rooms.
Response: We disagree with the commenters regarding the equipment
time for the CT room (EL007) due to the longstanding convention in the
direct PE inputs, shared by 38 other codes, to assign an equipment time
of 9 minutes for the equipment room in radiological supervision and
interpretation procedure. We agree with the commenters that at least
some portion of the procedure is performed in the CT room, but we
continue to believe that it would not serve the interests of relativity
to increase the equipment time for the CT room in CPT code 77012
without also addressing the equipment room time for the other
radiological supervision and interpretation procedures in a more
comprehensive fashion. We also disagree with the commenters that this
policy is specific to angiography rooms, as CPT codes 75989 and 77012
both employ CT rooms and currently utilize the standardized 9 minutes
of equipment time for radiological supervision and interpretation
procedures.
After consideration of the public comments, we are finalizing the
work RVU and direct PE inputs for CPT code 77012 as proposed.
(45) Dual-Energy X-Ray Absorptiometry (CPT Code 77081)
CPT code 77081 (Dual-energy X-ray absorptiometry (DXA), bone
density study, 1 or more sites; appendicular skeleton (peripheral)
(e.g., radius, wrist, heel)) was identified as potentially misvalued on
a screen of codes with a negative intraservice work per unit of time
(IWPUT), with 2016 estimated Medicare utilization over 10,000 for RUC
reviewed codes and over 1,000 for Harvard valued and CMS/Other source
codes. For CY 2019, we proposed the RUC-recommended work RVU of 0.20
for CPT code 77081.
We did not propose any direct PE refinements for this code family.
The following is a summary of the public comments we received on
our proposals involving CPT code 77081.
Comment: Commenters were supportive of our proposal regarding the
work RVU for CPT code 77081.
Response: We appreciate the support for our proposals from the
commenters.
After consideration of the public comments, we are finalizing the
work RVU of 0.20 and direct PE inputs for CPT code 77081 as proposed.
(46) Breast MRI With Computer-Aided Detection (CPT Codes 77046, 77047,
77048, and 77049)
CPT codes 77058 (Magnetic resonance imaging, breast, without and/or
with contrast material(s); unilateral) and 77059 (Magnetic resonance
imaging, breast, without and/or with contrast material(s); bilateral)
were identified in 2016 on a high expenditure services screen across
specialties with Medicare allowed charges of $10 million or more. When
preparing to survey these codes, the specialties noted that the
clinical indications had changed for these exams. The technology had
advanced to make computer-aided detection (CAD) typical and these codes
did not parallel the structure of other magnetic resonance imaging
(MRI) codes. In June 2017 the CPT Editorial Panel deleted CPT codes
0159T, 77058, and 77059 and created four new CPT codes to report breast
MRI with and without contrast (including computer-aided detection).
The RUC recommended a work RVU of 1.45 for CPT code 77046 (Magnetic
resonance imaging, breast, without contrast material; unilateral). This
recommendation was based on a comparison with CPT codes 74176 (Computed
tomography, abdomen and pelvis; without contrast material) and 74177
(Computed tomography, abdomen and pelvis; with contrast material(s)),
which both have similar intraservice and total times in relation to CPT
code 77046. We disagreed with the RUC's recommended work RVU because we
did not believe that the reduction in total time of 15 minutes between
the new CPT code 77046 and the deleted CPT code 77058 was adequately
reflected in its recommendation. Although total time has decreased by
15 minutes, the only other difference between the two CPT codes is the
change in the descriptor from the phrase `without and/or with contrast
material(s)' to `without contrast material,' suggesting that there is
less work involved in the new CPT code than in the deleted CPT code.
Instead, we proposed a work RVU of 1.15 for CPT code 77046, which is
similar to the total time ratio between the new CPT code and the
deleted CPT code. It is also supported by a crosswalk to CPT code 77334
(Treatment devices, design and construction; complex (irregular blocks,
special shields, compensators, wedges, molds or casts)). CPT code 77334
has total time of 35 minutes, intraservice time of 30 minutes, and a
work RVU of 1.15.
CPT code 77047 (Magnetic resonance imaging, breast, without
contrast material; bilateral) describes the same work as CPT code
77046, but reflects a bilateral rather than the unilateral procedure.
The RUC recommended a work RVU of 1.60 for CPT code 77047. Since we
proposed a different work RVU for the unilateral procedure than the
value proposed by the RUC, we believe it is appropriate to recalibrate
the work RVU for CPT code 77047 relative to the RUC's recommended
difference in work between the two CPT codes. The RUC's recommendation
for

[[Page 59555]]

the bilateral procedure is 0.15 work RVUs larger than for the
unilateral procedure. Therefore, we proposed a work RVU of 1.30 for CPT
code 77047.
The RUC recommended a work RVU of 2.10 for CPT code 77048 (Magnetic
resonance imaging, breast, without and with contrast material(s),
including computer-aided detection (CAD-real time lesion detection,
characterization and pharmacokinetic analysis) when performed;
unilateral). CPT code 77048 is a new CPT code that bundles the deleted
CPT code for unilateral breast MRI without and/or with contrast
material(s) with CAD, which was previously reported, in addition to the
primary procedure CPT code, as CPT code 0159T (computer aided
detection, including computer algorithm analysis of MRI image data for
lesion detection/characterization, pharmacokinetic analysis, with
further physician review for interpretation, breast MRI). Consistent
with our belief that the proposed value for the base CPT code in this
series of new CPT codes (CPT code 77046) should be a work RVU of 1.15,
we are proposing a work RVU for CPT code 77048 that adds the RUC-
recommended difference in RUC-recommended work RVUs between CPT codes
77046 and 77048 (0.65 work RVUs) to the proposed work RVU for CPT code
77046. Therefore, we proposed a work RVU of 1.80 for CPT code 77048.
The last new CPT code in this series, CPT code 77049 (Magnetic
resonance imaging, breast, without and with contrast material(s),
including computer-aided detection (CAD-real time lesion detection,
characterization and pharmoacokinetic analysis) when performed;
bilateral) describes the same work as CPT code 77048, but reflects a
bilateral rather than a unilateral procedure. The RUC recommended a
work RVU of 2.30 for this CPT code. Similar to the process for valuing
work RVUs for CPT code 77047 and CPT code 77048, we believe that a more
appropriate work RVU is calculated by adding the difference in the RUC
recommended work RVU for CPT codes 77046 and 77049, to the proposed
value for CPT code 77046. Therefore, we proposed a work RVU of 2.00 for
CPT code 77049.
For the direct PE inputs, we proposed to refine the clinical labor
time for the ``Prepare, set-up and start IV, initial positioning and
monitoring of patient'' (CA016) activity from 7 minutes to 3 minutes
for CPT codes 77046 and 77047, and from 9 minutes to 5 minutes for CPT
codes 77048 and 77049. We noted that when the MRI of Lower Extremity
codes were reviewed during the previous rule cycle (CPT codes 73718-
73720), these codes contained either 3 minutes or 5 minutes of
recommended time for this same clinical labor activity. We also noted
that the current Breast MRI codes that are being deleted and replaced
with these four new codes, CPT codes 77058 and 77059, contain 5 minutes
of clinical labor time for this same activity. We had no reason to
believe that the new codes would require additional clinical labor time
for patient positioning, especially given that the recommended clinical
labor times are decreasing in comparison to the reference codes for
obtaining patient consent (CA011) and preparing the room (CA013).
Therefore, we refined the clinical labor time for the CA016 activity as
detailed earlier to maintain relativity with the current clinical labor
times in the reference codes, as well as with other recently reviewed
MRI procedures.
Included in the recommendations for this code family were five new
equipment items: CAD Server (ED057), CAD Software (ED058), CAD
Software--Additional User License (ED059), Breast coil (EQ388), and CAD
Workstation (CPU + Color Monitor) (ED056). We did not receive any
invoices for these five equipment items, and as such we do not have any
direct pricing information to use in their valuation. We proposed to
use crosswalks to similar equipment items as proxies for three of these
new types of equipment until we do have pricing information:
CAD software (ED058) is crosswalked to flow cytometry
analytics software (EQ380).
Breast coil (EQ388) is crosswalked to Breast biopsy device
(coil) (EQ371).
CAD Workstation (CPU + Color Monitor) (ED056) is
crosswalked to Professional PACS workstation (ED053).
We welcomed the submission of invoices with pricing information for
these three new equipment items for our consideration to replace the
use of these proxies. For the other two equipment items (CAD Server
(ED057) and CAD Software--Additional User License (ED059)), we did not
propose to establish a price at this time as we believe both of them
would constitute forms of indirect PE under our methodology. We do not
believe that the CAD Server or Additional User License would be
allocated to the use of an individual patient for an individual
service, and can be better understood as forms of indirect costs
similar to office rent or administrative expenses. We understand that
as the PE data age, these issues involving the use of software and
other forms of digital tools become more complex. However, the use of
new technology does not change the statutory requirement under which
indirect PE is assigned on the basis of direct costs that must be
individually allocable to a particular patient for a particular
service. We look forward to continuing to seek out new data sources to
help in updating the PE methodology.
We also proposed to refine the equipment times in accordance with
our standard equipment time formulas.
The following is a summary of the public comments we received on
our proposals involving the Breast MRI with Computer-Aided Detection
(CAD) family of codes.
Comment: A commenter disagreed with our use of deleted CPT code
77058 as a point of reference for considering whether the reduction in
work RVU in the new code, CPT code 77046, is commensurate with the
reduction in work time between the two codes. The commenter stated that
CMS should not compare these new services with the old deleted
services, as indicated by the specialty society having demonstrated
compelling evidence that the work involved in the breast MRI code
family has fundamentally changed.
Response: We disagree that it is inappropriate to use time
comparisons with a code that is being deleted as a guide for assessing
whether the reduction in work RVU recommended by the RUC is
commensurate with the reduction in time based on survey results. The
description of the work involved in furnishing CPT code 77046 has not
changed substantively from the code being deleted. The compelling
evidence that the commenter cites is related to the two new codes, CPT
code 77048 and 77049, which are newly bundled with CAD. The main
distinction in the description of physician work for this CPT code is
that the new code specifies `without contrast', while the deleted code
described the service `without and/or with contrast.' The change in
patient population, also cited by the commenter, actually suggests that
the more complex patients will be screened using the advanced
technologies, such as is described by CPT code 77048. We recognize that
changes in technology and work flow for the work described by CPT code
77046 have affected the work involved in furnishing these services.
This is why we use the time ratios as a starting point for code
comparisons rather than the end point.
Comment: One commenter stated that our proposed crosswalk code for
CPT 77046, CPT code 77334, is inappropriate because of different
preservice and intraservice times between the two codes, and because
there is more low-

[[Page 59556]]

intensity time in CPT code 77334 compared with CPT code 77046. The
commenter also indicated that our proposed work RVU for CPT code 77046
would create a rank order anomaly with other MRI codes.
Response: As a matter of principle, we do not agree that a chosen
crosswalk for a CPT code is required to be clinically similar or to
have identical intraservice and/or total time as the code being valued.
However, in this instance, after further consideration, we agree with
the commenter that our crosswalk code, CPT 77334, is not a particularly
good comparison, in terms of intensity, to CPT 77046. We also agree
with the commenter that our proposed work RVU for CPT code 77046 would
create an anomaly among other CPT codes involving MRI. We are
finalizing a work RVU for CPT code 77046 of 1.45, as recommended by the
RUC.
Comment: A commenter disagreed with our use of increments in
recalibrating work RVUs for codes that precede or follow a new or
revalued CPT code, as was the process underlying our proposed work RVUs
for CPT codes 77047, 77048, and 77049.
Response: The recalibration of CPT codes based on incremental
difference in the work RVUs recommended by the RUC is an established
methodology used by CMS to value the work involved in furnishing a
service. There are certain types of code groups, particularly those
with clear stepwise changes in intensity, as described by the RUC, for
which we believe this is entirely appropriate. We continue to believe
that this is an appropriate approach. However, having agreed with the
commenter that our proposed work RVU for CPT code 77046 should be
finalized at the RUC recommended work RVU of 1.45, we also believe that
it is unnecessary to recalibrate the RUC's recommended work RVUs for
the remainder of the three codes in the series. Therefore, we are
finalizing a work RVU of 1.60 for CPT code 77047, 2.10 for CPT code
77048, and 2.30 for CPT code 77049.
Comment: Several commenters disagreed with the CMS proposal to
refine the clinical labor time for the ``Prepare, set-up and start IV,
initial positioning and monitoring of patient'' (CA016) activity from 7
minutes to 3 minutes for CPT codes 77046 and 77047, and from 9 minutes
to 5 minutes for CPT codes 77048 and 77049. Commenters stated that the
rationale for this change was likely derived from reference to the
lower clinical labor times for this activity associated with lower
extremity MRI codes, and that it was an error to treat the clinical
labor time for this activity as akin to that for lower extremity MRI.
Commenters requested that CMS consider the experience of an 80-year-old
patient who needs assistance on and off the table, along with
reassurance, added explanation, IV insertion into delicate skin, and
other anxiety needs. Commenters stated that another major distinction
between breast MRI and extremity MRI is that the patient lies prone on
the coil, which requires an awkward process of positioning and causes
the need for additional clinical labor time.
Response: We continue to disagree with the commenters that the RUC-
recommended clinical labor time would be typical for these procedures.
As part of our review, we compared the clinical labor times for the
CA016 activity not only to the codes in the MRI of Lower Extremity
family, but also to the current Breast MRI codes that are being deleted
and replaced with these four new codes. CPT codes 77058 and 77059
contain 5 minutes of clinical labor time for this same activity, and we
do not agree that the clinical labor times would be increasing to 7 and
9 minutes in the newly created CPT codes, especially given that
commenters did not provide a rationale as to why time would be
increasing. We also note that while some patients will have conditions
that are more difficult than the typical case, such as the 80-year-old
patient described by the commenters, other patients would have
conditions that are less difficult than the typical case. We remind the
reader that valuation of services under the PFS is based on the typical
case and not the most difficult cases that may arise. We further note
that the clinical vignette for CPT code 77047 describes a 53-year old
female patient, not an 80-year old patient, and was stated to be
typical by 96 percent of the survey respondents.
Comment: A commenter stated that in the CMS refinements to the
direct PE inputs for these four CPT codes, CMS proposed to remove 1
minute from the CA014 activity code and proposed to add 1 minute to the
CA013 activity code. The commenter stated that this refinement was
inaccurate and encouraged CMS to modify this proposal by finalizing the
RUC-recommended direct PE inputs for clinical labor.
Response: We believe that the commenter may have been confused with
several of the other code families that included these clinical labor
refinements, which we described in the PE section of this final rule
under the Changes to Direct PE Inputs for Specific Services heading
(section II.B.3. of this final rule). We did not propose any
refinements to the CA014 clinical labor for the codes in this family.
Comment: Several commenters requested that CMS add 5 minutes to CPT
codes 77048 and 77049 to account for the time required to obtain vital
signs. Commenters stated that to maintain consistency within the codes
for MRI with contrast, they requested that new codes for breast MRI
with contrast receive an additional two minutes of time for MRI
technologist (L047A) bringing the total time for obtain vital signs to
5 minutes.
Response: We proposed in CY 2018 to assign 5 minutes of clinical
labor time for all codes that include the ``Obtain vital signs'' task,
that included at least 1 minute previously assigned to this task
regardless of the date of last review. After considering the comments,
we did not finalize our proposal to establish 5 minutes as the new
standard for the ``Obtain vital signs'' clinical labor task. As a
result, we do not agree with the commenters that the clinical labor
time for the CA010 activity should be increased to 5 minutes for CPT
codes 77048 and 77049, especially given that we did not make a proposal
to do so. We refer readers to the CY 2018 PFS final rule (82 FR 52990-
52991) for additional details about last year's proposal on this issue.
Comment: One commenter requested that CMS assign additional
clinical labor time for MRI procedures with contrast in order to
account for time spent counseling patients. Commenters stated that
because of the increased public awareness of the risk relating to
gadolinium, additional time is required to explain the benefits and
risks of the procedure.
Response: We note that the MRI procedures in this family that are
done with contrast (CPT codes 77048 and 77049) already contain more
clinical labor than the MRI procedures that are done without contrast
(CPT codes 77046 and 77047). Specifically, these procedures already
contain two additional minutes for ``Provide education/obtain consent''
(CA011) clinical labor than the non-contrast versions of the
procedures, which we believe indicates that the concerns of the
commenters have been taken into account.
Comment: Several commenters stated that the lack of invoices for
the new equipment items may have been an oversight and enclosed new
invoices with their comment letter. Commenters also stated that the CAD
Software equipment (ED058) is actually synonymous with the ``breast
biopsy software'' (EQ370) equipment, and recognized that in hindsight
they should

[[Page 59557]]

have been consistent in identifying the equipment item between the
breast biopsy codes and the MR breast codes. One commenter disagreed
that the CAD Server or Additional User License equipment constituted
forms of direct PE, and requested that CMS consider the cost of CAD
service contracts and ``C-view'' costs in order to accurately access
the calculation of indirect practice expenses.
Response: We appreciate the submission of additional invoices from
the commenters to assist in pricing these new equipment items. As we
detailed in the Practice Expense portion of this final rule (section
II.B. of this final rule), we are finalizing an update in the price of
the CAD Software (ED058) equipment to $43,308.12 based on the new
invoice submission and additional review by the StrategyGen contractor.
We are also finalizing a price of $83,200 for the Breast coil (EQ388)
equipment and a price of $12,031.52 for the CAD Workstation (CPU +
Color Monitor) (ED056) based on the invoices submitted by the
commenters. For the other two equipment items (CAD Server (ED057) and
CAD Software--Additional User License (ED059)), we continue to believe
that both of them would constitute forms of indirect PE under our
methodology. The submitted invoices indicated that the CAD Server was a
server type used in a data center while the user license was for a
third license above and beyond the two licenses included in the price
of the CAD software. As we stated in the proposed rule, we do not
believe that these types of equipment would be allocated to the use of
an individual patient for an individual service, and can be better
understood as forms of indirect costs similar to office rent or
administrative expenses.
Comment: Several commenters stated that CMS had overstated the
useful life of a breast coil. The commenters stated that a coil will
start to display signs of wear, such as cracking of its case, flex
spots, exposed wiring, or a degradation of its attenuated field causing
a loss in image quality after about three to four years. Commenters
stated that a useful life of 5 years would be more appropriate and
consistent with the experience of their members.
Response: We appreciate the additional information regarding the
useful life of the breast coil equipment from the commenters. Our
proposal to use 10 years as the useful life for this new equipment was
based on our use of the breast biopsy device (EQ371) equipment as a
proxy. We agree with the commenters that it would be more accurate to
update the useful life to 5 years in light of this new information.
After consideration of the public comments, we are finalizing the
RUC-recommended work RVUs for the codes in the Breast MRI with
Computer-Aided Detection family of codes. We are finalizing the direct
PE inputs as proposed, with the updates to the pricing of the new
equipment as detailed above.
(47) Blood Smear Interpretation (CPT Code 85060)
CPT code 85060 (Blood smear, peripheral, interpretation by
physician with written report) was identified on a screen of CMS or
Other source codes with Medicare utilization greater than 100,000
services annually. For CY 2019, the RUC recommended a work RVU of 0.45
based on maintaining the current work RVU.
We disagreed with the recommended value and proposed a work RVU of
0.36 for CPT code 85060 based on the total time ratio between the
current time of 15 minutes and the recommended time established by the
survey of 12 minutes. This ratio equals 80 percent, and 80 percent of
the current work RVU of 0.45 equals a work RVU of 0.36. When we
reviewed CPT code 85060, we found that the recommended work RVU was
higher than nearly all of the other global XXX codes with similar time
values, and we do not believe that this blood smear interpretation
procedure would have an anomalously high intensity. Although we did not
imply that the decrease in time as reflected in survey values must
equate to a one-to-one or linear decrease in the valuation of work
RVUs, we believe that since the two components of work are time and
intensity, significant decreases in time should be reflected in
decreases to work RVUs. In the case of CPT code 85060, we believe that
it would be more accurate to propose the total time ratio at a work RVU
of 0.36 to account for these decreases in the surveyed work time.
The proposed work RVU was also based on the use of three crosswalk
codes. We directly supported the proposed valuation through a crosswalk
to CPT code 95930 (Visual evoked potential (VEP) checkerboard or flash
testing, central nervous system except glaucoma, with interpretation
and report), which has a work RVU of 0.35 along with 10 minutes of
intraservice time and 14 minutes of total time. We also explained the
proposed valuation by bracketing it between two other crosswalks, with
CPT code 99152 (Moderate sedation services provided by the same
physician or other qualified health care professional performing the
diagnostic or therapeutic service that the sedation supports; initial
15 minutes of intraservice time, patient age 5 years or older) on the
lower end at a work RVU of 0.25 and CPT code 93923 (Complete bilateral
noninvasive physiologic studies of upper or lower extremity arteries, 3
or more levels, or single level study with provocative functional
maneuvers) on the higher end at a work RVU of 0.45.
The RUC recommended no direct PE inputs for CPT code 85060 and we
proposed none.
The following is a summary of the public comments we received on
our proposals involving CPT code 85060.
Comment: Many commenters disagreed with the proposed work RVU of
0.36 for CPT code 85060 and stated that CMS should finalize the RUC-
recommended work RVU of 0.45. Commenters stated that a time ratio
should not be used because any decrease will result in a large ratio
and a corresponding but inappropriate decrease to the physician work
RVU. Commenters stated that rather than using time ratios CMS should
examine the magnitude estimation between the physician work, time, and
intensity. Commenters also stated that the current time was not based
on a survey and it was unclear how the time was determined.
Response: We disagree with the commenters and continue to believe
that the use of time ratios is one of several appropriate methods for
identifying potential work RVUs for particular PFS services,
particularly when the alternative values recommended by the RUC and
other commenters do not account for information provided by surveys
that suggests the amount of time involved in furnishing the service has
changed significantly. We reiterate that, consistent with the statute,
we are required to value the work RVU based on the relative resources
involved in furnishing the service, which include time and intensity.
When our review of recommended values reveals that changes in the
resource of time have been unaccounted for in a recommended RVU, then
we believe we have the obligation to account for that change in
establishing work RVUs since the statute explicitly identifies time as
one of the two elements of the work RVUs. We recognize that it would
not be appropriate to develop work RVUs solely based on time given that
intensity is also an element of work, but in applying the time ratios,
we are using derived intensity measures based on current work RVUs for
individual

[[Page 59558]]

procedures. Were we to disregard intensity altogether, the work RVUs
for all services would be developed based solely on time values and
that is definitively not the case, as indicated by the many services
that share the same time values but have different work RVUs. (As an
example, CPT codes 38222, 54231, 55870, 75573, and 78814 all share
identical CY 2019 work times with 15 minutes of preservice time, 30
minutes of intraservice time, and 15 minutes of postservice time;
however these codes have respective CY 2019 work RVUs of 1.44, 2.04,
2.58, 2.55, and 2.20.) Furthermore, we reiterate that we use time
ratios to identify potentially appropriate work RVUs, and then use
other methods (including estimates of work from CMS medical personnel
and crosswalks to key reference or similar codes) to validate these
RVUs. For more details on our methodology for developing work RVUs, we
direct readers to the discussion CY 2017 PFS final rule (81 FR 80272
through 80277).
Comment: Several commenters disagreed with our statement that the
recommended work value of 0.45 is higher than nearly all of the other
global XXX codes with similar time values. Commenters stated that a
search of the RUC database contradicted this finding, showing that
eleven XXX codes with 12 minutes of intraservice time have values lower
than 0.45 and thirteen XXX codes with 12 minutes of intraservice time
have values the same or higher than 0.45 RVUs. Commenters stated that
none of these services are pathology services and were not comparable,
except for CPT code 88388 (Macroscopic examination, dissection, and
preparation of tissue for non-microscopic analytical studies (e.g.,
nucleic acid-based molecular studies)) which has identical work value
and intra-service time and was the reference code cited in the RUC
recommendation. Commenters also disagreed with the CMS crosswalk to CPT
code 95930 due to the fact that it is not a pathology service.
Response: We disagree with the commenters' statement that pathology
services are only comparable to other pathology services. Although we
agree that the unique nature of pathology and laboratory services can
make comparisons across codes more difficult than in other services, we
believe the comparison of codes with similar work RVUs across different
specialties is important to maintaining the relativity of the PFS. We
disagree with the commenters that the crosswalk to CPT code 95930 would
be methodologically inappropriate solely on the grounds that it is not
a pathology service.
Comment: Several commenters stated that there are a number of
variables that must be considered in the evaluation of a blood smear
when compared to others, including red blood cell count, size and
morphology, platelet morphology and number, white blood cell morphology
and the presence of white blood cell precursors. Commenters stated that
other services with identical physician work include CPT code 88314
(Special stain including interpretation and report; histochemical stain
on frozen tissue block) and CPT code 93923 (Complete bilateral
noninvasive physiologic studies of upper or lower extremity arteries, 3
or more levels). Commenters stated the proposed work value would create
significant rank order anomalies within the array of pathology
services, as CPT code 85060 has nearly identical work time to CPT code
88314 but would be valued lower at the proposed work RVU.
Response: We appreciate the detailed information about CPT code
85060 provided by the commenters regarding the clinical comparisons to
CPT codes 88314 and 93923.
After consideration of the public comments, we are not finalizing
our proposed work RVU of 0.36 for CPT code 85060. We are finalizing the
RUC-recommended work RVU of 0.45 instead.
(48) Bone Marrow Interpretation (CPT Code 85097)
CPT code 85097 (Bone marrow, smear interpretation) was identified
on a screen of CMS or Other source codes with Medicare utilization
greater than 100,000 services annually. For CY 2019, the RUC
recommended a work RVU of 1.00 based on a direct crosswalk to CPT code
88121 (Cytopathology, in situ hybridization (e.g., FISH), urinary tract
specimen with morphometric analysis, 3-5 molecular probes, each
specimen; using computer-assisted technology).
We disagreed with the RUC-recommended value and we proposed a work
RVU of 0.94 for CPT code 85097 based on maintaining the current work
valuation. We noted that the survey indicated that CPT code 85097
typically takes 25 minutes of work time to perform, down from a
previous work time of 30 minutes, and, generally speaking, since the
two components of work are time and intensity, we believe that
significant decreases in time should be reflected in decreases to work
RVUs. For the specific case of CPT code 85097, we supported our
proposed work RVU of 0.94 through a crosswalk to CPT code 88361
(Morphometric analysis, tumor immunohistochemistry (e.g., Her-2/neu,
estrogen receptor/progesterone receptor), quantitative or
semiquantitative, per specimen, each single antibody stain procedure;
using computer-assisted technology), a recently reviewed code from CY
2018 with the identical time values and a work RVU of 0.95.
We also considered a work RVU of 0.90 based on double the
recommended work RVU of 0.45 for CPT code 85060 (Blood smear,
peripheral, interpretation by physician with written report). When both
of these CPT codes were under review, the explanation was offered that
in a peripheral blood smear, typically, the practitioner does not have
the approximately 12 precursor cells to review, whereas in an aspirate
from the bone marrow, the practitioner is examining all the precursor
cells. Additionally, for CPT code 85097, there are more cell types to
look at as well as more slides, usually four, whereas with CPT code
85060 the practitioner would typically only look at one slide. Although
we did not propose to value CPT code 85097 at twice the work RVU of CPT
code 85060, we believe this analysis also supports maintaining the
current work RVU of 0.94 as opposed to raising it to 1.00.
For the direct PE inputs, we proposed to remove the clinical labor
time for the ``Accession and enter information'' (PA001) and ``File
specimen, supplies, and other materials'' (PA008) activities. As we
stated previously, information entry and specimen filing tasks are not
individually allocable to a particular patient for a particular service
and are considered to be forms of indirect PE. Although we agree that
these are necessary tasks, under our established methodology we believe
that they are more appropriately classified as indirect PE.
The following is a summary of the public comments we received on
our proposals involving CPT code 85097.
Comment: Many commenters disagreed with the proposed work RVU of
0.94 for CPT code 85097 and stated that CMS should finalize the RUC-
recommended work RVU of 1.00. Commenters stated that the CMS rationale
about changes in work time was out of place in this context because the
survey respondents indicate that the service requires 25 minutes to
perform rather than the current time of 30 minutes, yet CMS proposed to
maintain the current work value. The commenters suggested that
maintaining the current work RVU of 0.94 was therefore inappropriate.
Commenters also stated that the current work time for CPT code 85097
was not based on a survey and that it was unknown how this time was

[[Page 59559]]

determined and what it actually represents.
Response: We agree that it is important to use the most recent data
available regarding time, and we note that when many years have passed
between when time is measured, significant discrepancies can occur.
However, we also believe that our operating assumption regarding the
validity of the existing values as a point of comparison is critical to
the integrity of the relative value system as currently constructed.
The times currently associated with codes play a very important role in
PFS ratesetting, both as points of comparison in establishing work RVUs
and in the allocation of indirect PE RVUs by specialty. If we were to
operate under the assumption that previously recommended work times had
routinely been overestimated, this would undermine the relativity of
the work RVUs on the PFS in general, given the process under which
codes are often valued by comparisons to codes with similar times, and
it also would undermine the validity of the allocation of indirect PE
RVUs to physician specialties across the PFS. Instead, we believe that
it is crucial that the code valuation process take place with the
understanding that the existing work times used in the PFS ratesetting
processes are accurate. We recognize that adjusting work RVUs for
changes in time is not always a straightforward process and that the
intensity associated with changes in time is not necessarily always
linear, which is why we apply various methodologies to identify several
potential work values for individual codes. However, we want to
reiterate that we believe it would be irresponsible to ignore changes
in time based on the best data available and that we are statutorily
obligated to consider both time and intensity in establishing work RVUs
for PFS services. For additional information regarding the use of old
work time values in our methodology, we refer readers to our discussion
of the subject in the CY 2017 final rule (81 FR 80273 through 80274).
With regard to the specific case of CPT code 85097, we proposed to
maintain the current work RVU rather than decreasing the work RVU due
to some of the same concerns about the historical work times for this
code raised by the commenters. We believe that the logic provided by
the commenters suggests that the decreases in the work time of CPT code
85097 should have been reflected in decreases to the work RVU (as
opposed to maintaining the current value), which we do not believe was
their intention.
Comment: Several commenters stated that given the total work, time,
intensity, and complexity of the patient case, the current work RVU of
0.94 was too low for CPT code 85097. Commenters stated that the RUC
chose a crosswalk to CPT code 88121 (Cytopathology, in situ
hybridization (e.g., FISH), urinary tract specimen with morphometric
analysis, 3-5 molecular probes, each specimen; using computer-assisted
technology) specifically because it is a similar pathology code with a
value between the current work value of 0.94 and the survey 25th
percentile of 1.15. Commenters stated that the CMS reference code (CPT
code 88361) was less intense and complex to perform as it involves
evaluating a single antibody and determining the percentage of tumor
cells that are positive for that antibody, as opposed to the work of
CPT code 85097 which involves evaluating all blood cell precursors for
quantitative and morphologic abnormalities, as well as evaluating for
metastatic tumor cells, evidence of infection, or evidence of lymphoid
neoplasms.
Response: We disagree with the commenters that the current work RVU
of 0.94 or the work RVU of our reference code of 88361 are too low in
comparison to CPT code 85097. All three of the codes under discussion
(CPT codes 85097, 88121, and 88361) are clinically similar procedures
that involve the practitioner using their eyes to look at staining
patterns. We do not agree with the commenters that the RUC's use of CPT
code 88121 as a crosswalk would be any more accurate on clinical
grounds that the reference code of 88361 that we chose in the proposed
rule. Overall, we do not believe that there is a significant difference
between these three procedures given their nearly identical work RVUs,
intensities, and work times. However, given the decrease in surveyed
work time, we continue to believe that it is more appropriate to
maintain the current work RVU of 0.94 than to increase it to 1.00 due
to our longstanding belief that decreases in work time should typically
be not be reflected in increases to the work RVU. We note that we are
not proposing to decrease the work RVU for CPT code 85097 despite this
decrease in the surveyed work time, only to maintain the current
valuation.
Comment: Several commenters responded to the CMS consideration of a
work RVU of 0.90 based on double the recommended work RVU of 0.45 for
CPT code 85060. Commenters stated that they wished to clarify that this
explanation was put forward to a RUC member whom was simply questioning
why this service requires twice the time of CPT code 85060. Commenters
stated that simply doubling the RUC-recommended work RVU of 0.45 for
CPT code 85060 based on the amount of time does not account for the
considerably greater intensity and complexity of CPT code 85097 over
CPT code 85060 as described elsewhere in their comments.
Response: We appreciate the clarification on this issue from the
commenters.
Comment: Several commenters disagreed with the CMS proposal remove
the clinical labor time for the ``Accession and enter information''
(PA001) and ``File specimen, supplies, and other materials'' (PA008)
activities. Commenters stated that although the descriptions for the
PA001 and PA008 clinical labor activities appeared to describe data
entry and filing activities, these tasks are very different in the
pathology lab. Commenters stated that it is crucial for the performance
of these tasks be executed accurately according to rigid patient
laboratory protocols, standards, and legal processes associated with
specimen/patient care and they should not be considered a form of
indirect expense.
Response: Although we agree that the unique nature of pathology and
laboratory services can make comparisons across codes more difficult
than for other services, we believe the comparison of similar clinical
labor activities across different services is important to maintaining
the relativity of the direct PE inputs. As we stated in the CY 2017 PFS
final rule (81 FR 80324), we agree with the commenters that entering
patient data into information systems and filing specimens are
important tasks, and we agree that these would take more than zero
minutes to perform. However, we continue to believe that these
activities are correctly categorized as indirect PE as administrative
functions, and therefore, we do not recognize the entry of patient data
or the filing of specimens as direct PE inputs, and we do not consider
this task as typically performed by clinical labor on a per-service
basis.
After consideration of the public comments, we are finalizing the
work RVU and direct PE inputs for CPT code 85097 as proposed.
(49) Fibrinolysins Screen (CPT Code 85390)
CPT code 85390 (Fibrinolysins or coagulopathy screen,
interpretation and report) was identified as potentially misvalued on a
screen of codes with a negative IWPUT, with 2016 estimated Medicare
utilization over 10,000 for

[[Page 59560]]

RUC reviewed codes and over 1,000 for Harvard valued and CMS/Other
source codes. For CY 2019, we are proposing the RUC-recommended work
RVU of 0.75 for CPT code 85390. Because this is a work only code, the
RUC did not recommend, and we did not propose any direct PE inputs for
CPT code 85390.
The following is a summary of the public comments we received on
our proposals involving CPT code 85390.
Comment: A commenter expressed support for our proposal to accept
the RUC-recommended work RVU for this code.
Response: We appreciate the support for our proposals from the
commenter.
After consideration of the public comments, we are finalizing our
proposal to accept the RUC-recommended work RVU for this code.
(50) Electroretinography (CPT Codes 92273, 92274, and 0509T)
CPT code 92275 (Electroretinography with interpretation and report)
was identified in 2016 on a high expenditure services screen across
specialties with Medicare allowed charges of $10 million or more. In
January 2016, the specialty society noted that they became aware of
inappropriate use of CPT code 92275 for a less intensive version of
this test for diagnosis and indications that are not clinically proven
and for which less expensive and less intensive tests already exist.
CPT changes were necessary to ensure that the service for which CPT
code 92275 was intended was clearly described, as well as an accurate
vignette and work descriptor were developed. In September 2017, the CPT
Editorial Panel deleted CPT code 92275 and replaced it with two new
codes to describe electroretinography full field and multi focal. A
category III code was retained for pattern electroretinography.
For CPT code 92273 (Electroretinography (ERG) with interpretation
and report; full field (e.g., ffERG, flash ERG, Ganzfeld ERG)), we
disagreed with the recommended work RVU of 0.80 and we instead proposed
a work RVU of 0.69 based on a direct crosswalk to CPT code 88172
(Cytopathology, evaluation of fine needle aspirate; immediate
cytohistologic study to determine adequacy for diagnosis, first
evaluation episode, each site). CPT code 88172 is another
interpretation procedure with the same 20 minutes of intraservice time,
which we believe is a more accurate comparison for CPT code 92273 than
the two reference codes chosen by the survey participants due to their
significantly higher and lower intraservice times. We noted that the
recommended intraservice time for CPT code 92273 as compared to its
predecessor CPT code 92275 is decreasing from 45 minutes to 20 minutes
(56 percent reduction), and the recommended total time is decreasing
from 71 minutes to 22 minutes (69 percent reduction); however, the work
RVU is only decreasing from 1.01 to 0.80, which is a reduction of just
over 20 percent. Although we did not imply that the decreases in time
as reflected in survey values must equate to a one-to-one or linear
decrease in the valuation of work RVUs, we believe that since the two
components of work are time and intensity, significant decreases in
time should be reflected in decreases to work RVUs. In the case of CPT
code 92273, we have reason to believe that the significant drops in
surveyed work time as compared to CPT code 92275 are a result of
improvements in technology since the predecessor code was reviewed. The
older machines used for electroretinography were slower and more
cumbersome, and now the same work for the service can be performed in
significantly less time. Therefore, we proposed a work RVU of 0.69
based on the direct crosswalk to CPT code 88172, which we believe more
accurately accounts for these decreases in surveyed work time.
For CPT code 92274 (Electroretinography (ERG) with interpretation
and report; multifocal (mfERG)), we disagreed with the RUC-recommended
work RVU of 0.72 and proposed a work RVU of 0.61. We concurred that the
relative difference in work between CPT code 92273 and 92274 is
equivalent to the recommended interval of 0.08 RVUs. Therefore, we
proposed a work RVU of 0.61 for CPT code 92274, based on the
recommended interval of 0.08 fewer RVUs below our proposed work RVU of
0.69 for CPT code 92273. The proposed work RVU is also based on the use
of two crosswalk codes: CPT code 88387 (Macroscopic examination,
dissection, and preparation of tissue for non-microscopic analytical
studies; each tissue preparation); and CPT code 92100 (Serial tonometry
(separate procedure) with multiple measurements of intraocular pressure
over an extended time period with interpretation and report, same day).
Both codes share the same 20 minutes of intraservice and 20 minutes of
total time, with a work RVU of 0.62 for CPT code 88387 and a work RVU
of 0.61 for CPT code 92100.
The recommendations for this code family also include CPT Category
III code 0509T (Electroretinography (ERG) with interpretation and
report, pattern (PERG)). We typically assign contractor pricing for
Category III codes since they are temporary codes assigned to emerging
technology and services. However, in cases where there is an unusually
high volume of services that will be performed under a Category III
code, we have sometimes assigned an active status to the procedure and
developed RVUs before a formal CPT code is created. In the case of CPT
code 0509T, the recommendations indicate that approximately 80 percent
of the services currently reported under CPT code 92275 will be
reported under the new Category III code. Since this will involve an
estimated 100,000 services for CY 2019, we believe that the interests
of relativity would be better served by assigning an active status to
CPT code 0509T and creating RVUs through the use of a proxy crosswalk
to a similar existing service. Therefore, we proposed to assign an
active status to CPT Category III code 0509T for CY 2019, with a work
RVU and work time values crosswalked from CPT code 92250 (Fundus
photography with interpretation and report). CPT code 92250 is a
clinically similar procedure that was recently reviewed during the CY
2017 rule cycle. We proposed a work RVU of 0.40 and work times of 10
minutes of intraservice and 12 minutes of total time for CPT code 0509T
based on this crosswalk to CPT code 92250.
For the direct PE inputs, we proposed to remove the preservice
clinical labor in the facility setting for CPT codes 92273 and 92274.
Both of these codes are diagnostic tests under which the professional
(26 modifier) and technical (TC modifier) components will be separately
billable, and codes that have these professional and technical
components typically will not have direct PE inputs in the facility
setting since the technical component is only valued in the nonfacility
setting. We also noted on this subject that the predecessor code, CPT
code 92275, does not currently include any preservice clinical labor,
nor any facility direct PE inputs.
We proposed to remove the clinical labor time for the ``Greet
patient, provide gowning, ensure appropriate medical records are
available'' (CA009) and the ``Provide education/obtain consent''
(CA011) activities for CPT codes 92273 and 92274. Both of these CPT
codes will typically be reported with a same day E/M service, and we
believe that these clinical labor tasks will be carried out during the
E/M service. We believe that their inclusion in CPT codes 92273 and
92274 would be duplicative. We also proposed to refine the clinical
labor time for the

[[Page 59561]]

``Prepare room, equipment and supplies'' (CA013) activity to 3 minutes
and to refine the clinical labor time for the ``Confirm order, protocol
exam'' (CA014) activity to 0 minutes for both codes. The predecessor
CPT code 92275 did not previously have clinical labor time assigned for
the ``Confirm order, protocol exam'' clinical labor task, and we did
not have any reason to believe that the services being furnished by the
clinical staff had changed in the new codes, only the way in which this
clinical labor time has been presented on the PE worksheets. We also
noted that there is no effect on the total clinical labor direct costs
in these situations since the same 3 minutes of clinical labor time is
still being furnished.
We proposed to refine the clinical labor time for the ``Clean room/
equipment by clinical staff'' (CA024) activity from 12 minutes to 8
minutes for CPT codes 92273 and 92274. The recommendations for these
codes stated that cleaning is carried out in several steps: The patient
is first cleaned for 2 minutes, followed by wires and electrodes being
scrubbed carefully with detergent, soaked, and then rinsed with sterile
water. We agree with the need for 2 minutes of patient cleaning time
and for the cleaning of the wires and electrodes to take place in two
different steps. However, our standard clinical labor time for room/
equipment cleaning is 3 minutes, and therefore, we proposed a total
time of 8 minutes for these codes, based on 2 minutes for patient
cleaning and then 3 minutes for each of the two steps of wire and
electrode cleaning.
We proposed to refine the clinical labor time for the
``Technologist QC's images in PACS, checking for all images, reformats,
and dose page'' (CA030) activity from 10 minutes to 3 minutes for CPT
codes 92273 and 92274. We finalized in the CY 2017 PFS final rule (81
FR 80184-80186) a range of appropriate standard minutes for this
clinical labor activity, ranging from 2 minutes for simple services up
to 5 minutes for highly complex services. We believe that the
complexity of the imaging in CPT codes 92273 and 92274 is comparable to
the CT and magnetic resonance (MR) codes that have been recently
reviewed, such as CPT code 76391 (Magnetic resonance (e.g., vibration)
elastography). Therefore, in order to maintain relativity, we proposed
the same clinical labor time of 3 minutes for CPT codes 92273 and 92274
that has been recommended for these CT and MR codes. We also proposed
to refine the clinical labor time for the ``Review examination with
interpreting MD/DO'' (CA031) activity from 5 minutes to 2 minutes for
CPT codes 92273 and 92274. We also finalized in the CY 2017 PFS final
rule a standard time of 2 minutes for reviewing examinations with the
interpreting MD, and we have no reason to believe that these codes
would typically require additional clinical labor at more than double
the standard time.
We noted that the new equipment item ``Contact lens electrode for
mfERG and ffERG'' (EQ391) was listed twice for CPT code 92273 but only
a single time for CPT code 92274. We solicited additional information
about whether the recommendations intended this equipment item to be
listed twice, with one contact intended for each eye, or whether this
was a clerical mistake. We are also interested in additional
information as to why the contact lens electrode was listed twice for
CPT code 92273 but only a single time for CPT code 92274. Finally, we
also proposed to refine the equipment times in accordance with our
standard equipment time formulas.
We proposed to use the direct PE inputs for CPT code 92274,
including the refinements detailed above, as a proxy for CPT Category
III code 0509T until it can be separately reviewed by the RUC.
The following is a summary of the public comments we received on
our proposals involving the Electroretinography family of codes.
Comment: Many commenters disagreed with the proposed work RVU of
0.69 for CPT code 92273 and stated that CMS should finalize the RUC-
recommended work RVU of 0.80. Commenters stated that the RUC-
recommended work RVU was based on the survey 25th percentile and CMS
should use survey data in establishing the work RVU. Commenters stated
that the decrease in intraservice work time of deleted CPT code 92275
from when it was last surveyed in 1995 was due to the fact that the
physician no longer participates in the acquisition of the data or
performing the test on the patient, which has become the technician's
work. Commenters stated that the RUC determined that the physician work
is not the same as it was with CPT code 92275 and the recommended
decrease in work RVUs appropriately addresses the decrease in physician
time to perform this service.
Response: We disagree with the commenters that the RUC-recommended
decrease in work RVUs appropriately addresses the decrease in physician
time to perform this service. As we stated in the proposed rule, the
recommended intraservice time for CPT code 92273 as compared to its
predecessor CPT code 92275 is decreasing from 45 minutes to 20 minutes
(56 percent reduction), and the recommended total time is decreasing
from 71 minutes to 22 minutes (69 percent reduction); however, the RUC-
recommended work RVU is only decreasing from 1.01 to 0.80, which is a
reduction of just over 20 percent. Although we did not imply that the
decreases in time as reflected in survey values must equate to a one-
to-one or linear decrease in the valuation of work RVUs, we believe
that since the two components of work are time and intensity,
significant decreases in time should be reflected in decreases to work
RVUs. As a result, we believe that our proposed work RVU of 0.69 more
accurately captures the changes in work that have taken place since the
previous survey.
Comment: Several commenters stated that while the time required for
CPT code 92273 is less than the time required for CPT code 92275, the
code it replaced, the intensity and complexity of the work involved in
interpreting the test has increased significantly. Commenters stated
that the newer machines are easily programmed to produce more images
and numbers for interpretation (double or more) than the machines in
use in 1995 when the procedure was last valued and that advances in
medical knowledge have identified more specific retinal dystrophy
diagnoses with specific genotypes that the clinician must consider when
interpreting the test. Commenters emphasized that while the machine may
be more efficient as stated by CMS, the cognitive work required by the
physician interpreting the test has increased significantly.
Response: We disagree with the commenters that all of the
efficiencies gained in work time via improved technology would be
offset via higher intensity (that is, greater cognitive work on the
part of the practitioner). While the incorporation of new technology
can sometimes make services more complex and difficult to perform, it
can also have the opposite effect by making services less reliant on
manual skill and technique. At the RUC-recommended work RVU of 0.80,
the intensity of CPT code 92273 would increase by nearly 300 percent,
and we do not agree that the cognitive intensity of the procedure would
have increased by this amount. We continue to believe that our proposed
work RVU of 0.69 more accurately captures the changes in work taking
place as a result of greater technological efficiencies in the service.

[[Page 59562]]

Comment: Many commenters disagreed with the proposed work RVU of
0.61 for CPT code 92274 and stated that CMS should finalize the RUC-
recommended work RVU of 0.72. Commenters stated that CMS should use
valid methods of evaluating services, such as survey data and magnitude
estimation, instead of relying on an incremental difference in work
RVUs between codes 92273 and 92274.
Response: We believe the use of an incremental difference between
codes is a valid methodology for setting values, especially in valuing
services within a family of revised codes where it is important to
maintain appropriate intra-family relativity. Historically, we have
frequently utilized an incremental methodology in which we value a code
based upon its incremental difference between another code or another
family of codes. We note that the RUC has also used the same
incremental methodology on occasion when it was unable to produce valid
survey data for a service. We further note that we did not rely solely
on an increment for our proposed work RVU for CPT code 92274, as the
proposed work RVU was also based on the use of a reference code (CPT
code 88387) and a crosswalk code (CPT code 92100). Both codes share the
same 20 minutes of intraservice and 20 minutes of total time, with a
work RVU of 0.62 for CPT code 88387 and a work RVU of 0.61 for CPT code
92100.
Comment: Several commenters stated that while there was no
predecessor code for direct comparison, the intensity and complexity of
the work involved in interpreting the test has increased significantly
compared to 1995, when CPT code 92275 was last valued. Commenters
restated the same arguments they expressed for CPT code 92273: The new
machines used in CPT code 92274 have become more efficient but the
cognitive work required by the physician interpreting the test has
increased significantly.
Response: As we stated with regard to CPT code 92273, we continue
to disagree with the commenters that all of the efficiencies gained in
work time via improved technology would be offset via higher intensity
(that is, greater cognitive work on the part of the practitioner). At
the RUC-recommended work RVU of 0.72, the intensity of CPT code 92274
would also increase by nearly 300 percent, and we do not agree that the
cognitive intensity of the procedure would have increased by this
amount. We continue to believe that our proposed work RVU of 0.61 more
accurately captures the changes in work taking place as a result of
greater technological efficiencies in the service.
Comment: Several commenters stated that CPT code 92274 requires
more physician work than the crosswalks we identified. Commenters
stated that CPT code 88387 is a straightforward manual dissection that
does not require interpretation of multiple images and numeric values
to arrive at a diagnosis. Commenters stated that CPT code 92100 also
requires less physician work, as CPT code 92274 requires interpretation
of significantly more data and consideration of many more diagnostic
possibilities.
Response: We disagree with the commenters that our reference and
crosswalk codes require less work than CPT code 92274. While it is true
that CPT code 88387 does not require interpretation of multiple images
and numeric values, this is because it is not an imaging service, and
it is inappropriate to state that the work of CPT code 88387 is lower
than CPT code 92274 based on this criteria. We do not agree that the
macroscopic examination, dissection, and preparation of tissue taking
place in CPT code 88387 would inherently constitute less work than CPT
code 92274. Similarly, we do not agree that the serial tonometry with
multiple measurements of intraocular pressure taking place in CPT code
92100 would involve less work than CPT code 92274, especially due to
the nearly identical intraservice and total work times shared by these
procedures.
Comment: One commenter disagreed with our proposal to assign active
pricing to Category III code 0509T. The commenter stated that this code
should go through the regular vetting process that other new technology
typically follows, including development of appropriate clinical
literature that would qualify it for elevation to a full Category I CPT
code, and then a RUC survey in order to develop accurate valuation for
work and practice expense. The commenter was concerned that CMS would
single out and put forward a value for a technology that has not gone
through the same scrutiny as other new technologies.
Response: We understand the concerns expressed by the commenter. As
we stated in the proposed rule, we typically assign contractor pricing
for Category III codes since they are temporary codes assigned to
emerging technology and services. However, in cases where there is an
unusually high volume of services that will be performed under a
Category III code, we have sometimes assigned an active status to the
procedure, and in the case of Category III code 0509T the
recommendations indicated that approximately 80 percent of the services
currently reported under CPT code 92275 will be reported under the new
Category III code. Since this will involve an estimated 100,000
services for CY 2019, we continue to believe that the interests of
relativity would be better served by assigning an active status to
Category III code 0509T and creating RVUs through the use of a proxy
crosswalk to a similar existing service. We agree with the commenter
that this code should still go through the regular vetting process that
other new technology typically follows, and we look forward to
receiving recommendations for work and practice expense inputs in the
future.
Comment: One commenter stated that many of the proposed changes to
the direct PE inputs were made with the intent to standardize inputs.
The commenter stated that although the RUC has created many standards,
they have always acknowledged that there are and will be exceptions to
those standards. The commenter stated that these important diagnostic
tests are unusual services that require significant amounts of
preservice clinical labor time in whichever setting they are performed,
and that the recommended direct PE inputs were carefully prepared based
upon documented personal observation and time motion studies. The
commenter stated that the predecessor CPT code 92275 had an over-
simplified PE spreadsheet with very few data inputs, each comprising
substantial amounts of time that are now broken out into separate
inputs, and as a result the work required had not changed substantially
but there had been additional granularity in the direct PE inputs.
Response: As we noted in the CY 2015 PFS final rule with comment
period (79 FR 67640 through 67641), we continue to make improvements to
the direct PE input database to provide the number of clinical labor
minutes assigned for each task for every code in the database instead
of only including the number of clinical labor minutes for the
preservice, service, and postservice periods for each code. We have
stated that we believe this additional level of detail helps to
facilitate transparency, allows us to more easily compare clinical
labor times across the PFS to maintain relativity, and helps in
maintaining standard times for particular clinical labor tasks that can
be applied consistently to many codes as they are valued over several
years. However, we have always recognized that standards for clinical
labor cannot be applied universally due to the differences between
individual services, and we have frequently finalized

[[Page 59563]]

clinical labor times above the standard values where we believed that
there was sufficient reason to establish these values as the typical
case. In the case of CPT code 92273 and 92274, we detailed our
rationale in the proposed rule for why we believed that some of the
RUC-recommended direct PE inputs should be refined to a standard
clinical labor time. We also note that we did not propose the standard
clinical labor time for all activities, such as the ``Clean room/
equipment by clinical staff'' (CA024) activity.
Comment: Several commenters disagreed with the proposal to remove
the preservice clinical labor in the facility setting for CPT codes
92273 and 92274. Commenters stated that these procedures, when done in
a facility, must be scheduled in the operating room. Commenters stated
that these procedures would typically be done in the facility only when
it is not clinically appropriate for them to be performed in the
clinic, such as for children or the cognitively impaired; and it takes
substantial amounts of time for the staff to accomplish this
coordination of care for these higher-needs patients.
Response: We recognize that these procedures are rarely performed
in the facility setting, with approximately 1 percent of the
utilization of predecessor CPT code 92275 taking place in this setting.
However, we disagree that these procedures would typically be performed
in the operating room when furnished in the facility, and therefore, we
do not agree that these procedures would typically require preservice
clinical labor for coordination of care. We also noted on this subject
that the predecessor code, CPT code 92275, does not currently include
any preservice clinical labor, nor any facility direct PE inputs, and
we did not receive an explanation from the commenters as to why this
was the case. Furthermore, both of these codes are diagnostic tests
under which the professional (26 modifier) and technical (TC modifier)
components will be separately billable, and codes that have these
professional and technical components typically will not have direct PE
inputs in the facility setting since the technical component is only
valued in the nonfacility setting.
Comment: Several commenters disagreed with the proposal to remove
the clinical labor time for the ``Greet patient, provide gowning,
ensure appropriate medical records are available'' (CA009) and the
``Provide education/obtain consent'' (CA011) activities for CPT codes
92273 and 92274. Commenters stated that although slightly more than 50
percent of these services are done on the same day as an office visit,
the clinical staff time involved is completely divorced from the office
visit and the staff performing the test are different from the staff
assisting in the office visit. Commenters stated that the machine used
for these procedures is housed in a different room, the patient needs
to be transported from the ophthalmic exam lane to the ERG room and
back, additional instructions are required that are never done during a
typical office visit, and the nature of this test requires extra
supplies and work in addition to those used for the office visit.
Commenters emphasized that these clinical tasks are not duplicative
with an E/M, as they represent separate actions by a different
technician in a different room.
Response: We disagree with the commenters and continue to believe
that this clinical labor would be duplicative with the same day E/M
office visit. While it is true that there is a different clinical labor
staff type used by CPT codes 92273 and 92274, we are not suggesting
that all clinical labor is duplicative with the same day E/M visit,
only that clinical labor activities such as greeting and gowning the
patient would only be done a single time. We also note that we do not
include patient transportation as a form of direct PE, as it is not
individually allocable to a single service and would instead be
classified as an administrative task under indirect PE. However, we do
agree with the commenters that additional instructions would be
required for these electroretinography services, and as a result we
will restore the 1 minute of clinical labor time for the ``Provide
education/obtain consent'' (CA011) activity. We agree that this would
not be duplicative with the same day E/M office visit.
Comment: Several commenters stated that in our refinements to the
direct PE inputs for CPT codes 92273 and 92274, CMS proposed to remove
1 minute from the CA014 activity code and proposed to add 1 minute to
the CA013 activity code. The commenter stated that this refinement was
inaccurate and encouraged CMS to modify this proposal by finalizing the
RUC-recommended direct PE inputs for clinical labor. One commenter
stated that this work is done by a different technician in a different
room typically in a busy clinical setting and this work was separate
from that being done during the office visit.
Response: We addressed this subject in detail in the PE section of
this final rule under the Changes to Direct PE Inputs for Specific
Services heading (section II.B.3. of this final rule). For CPT codes
92273 and 92274, we are finalizing these clinical labor refinements as
proposed. We also note in response to the one commenter that our
refinements to the CA013 and CA014 clinical labor activities were not
based on the premise on being duplicative with the same day E/M visit.
Comment: Several commenters disagreed with the proposal to refine
the clinical labor time for the ``Clean room/equipment by clinical
staff'' (CA024) activity from 12 minutes to 8 minutes for CPT codes
92273 and 92274. Commenters stated that this was the time that the
specialty society found when directly shadowing the process to clean
the patient and the equipment. Commenters stated that the technician
needs to clean the patient's skin, rinse their eyes, and clean around
the patient and escort them out. Commenters stated that the expensive
and delicate eye electrodes require a significant amount of time to
remove and clean the conductive paste and Goniosol without damaging the
electrodes, which needs to be performed after each procedure so that
the electrodes can be re-used for the next procedure. Commenters
emphasized that the equipment cleaning process requires meticulous care
and a significant amount of technician time.
Response: We agree with the commenters that these procedures
require more time for cleaning the room and equipment than the standard
for the CA024 activity. This is the reason we proposed 8 minutes of
clinical labor time instead of 3 minutes, almost triple the standard
value for this activity code. As we stated in the proposed rule, we
agreed with the need for 2 minutes of patient cleaning time and for the
cleaning of the wires and electrodes to take place in two different
steps. Since our standard clinical labor time for room/equipment
cleaning is 3 minutes, we therefore proposed a total time of 8 minutes
for these codes, based on 2 minutes for patient cleaning and then 3
minutes for each of the two steps of wire and electrode cleaning. We
continue to believe that 8 minutes would be the typical amount of
clinical labor used for these procedures.
Comment: Several commenters disagreed with the proposal to refine
the clinical labor time for the ``Technologist QC's images in PACS,
checking for all images, reformats, and dose page'' (CA030) activity
from 10 minutes to 3 minutes for CPT codes 92273 and 92274. Commenters
stated that the machine used for the ERG codes is not typically
integrated into the clinic's electronic medical record. Commenters
stated that this machine requires printing all images created by the
testing

[[Page 59564]]

machine and uploading them into the EMR for subsequent review by the
physician and that it is not unusual for re-printing using a different
scale or limits to be necessary. Commenters stated that this clinical
labor differed from a typical radiology scenario because the procedure
is in fact different from a typical imaging study.
Response: We disagree with the commenters that the full recommended
time of 10 minutes would be typical for this clinical labor activity.
We do not agree that it would be typical to physically print out all of
the images produced by the machine, and note that we do not include
additional direct PE inputs for inefficiencies in practice operations.
We continue to believe that the complexity of the imaging in CPT codes
92273 and 92274 is comparable to the CT and magnetic resonance (MR)
codes, and that in order to maintain relativity, we proposed the same
clinical labor time of 3 minutes.
Comment: Several commenters disagreed with the proposal to refine
the clinical labor time for the ``Review examination with interpreting
MD/DO'' (CA031) activity from 5 minutes to 2 minutes for CPT codes
92273 and 92274. Commenters stated that this input was calculated by
direct observation of typical procedures with a stopwatch. Commenters
stated that this test is performed in a different room than the office
visit, and the technician needs to take time to find the ordering/
interpreting physician and review the quality of the gain and results.
Response: We disagree with the commenters that the full recommended
time of 5 minutes would be typical for this clinical labor activity. We
note again that we do not include additional direct PE inputs for
inefficiencies in practice operations, and that we would not increase
the clinical labor to include time that the technician needs to find
the ordering/interpreting physician. We finalized in the CY 2017 PFS
final rule a standard time of 2 minutes for reviewing examinations with
the interpreting MD, and we have no reason to believe that these codes
would typically require additional clinical labor at more than double
the standard time.
Comment: Several commenters responded to the comment solicitation
regarding additional information about whether the recommendations for
the ``Contact lens electrode for mfERG and ffERG'' (EQ391) equipment
intended this equipment item to be listed twice, with one contact
intended for each eye, or whether this was a clerical mistake.
Commenters stated that this was not an error but was intentional and
reflects typical practice. Commenters stated that the test carried out
in CPT code 92273 is performed with two contact lenses in place (one in
each eye at the same time) in a simultaneous testing fashion.
Commenters stated that the test carried out in CPT code 92274 is
typically performed sequentially one eye at a time, re-using the same
contact lens for each eye. Commenters stated that this discrepancy is
primarily due to the dark and light-adaptation needs for the ffERG,
which if done sequentially would double the amount of clinical time.
Response: We appreciate the additional information supplied by the
commenters in response to our comment solicitation.
Comment: One commenter stated that the highly technical equipment
formula should be used for the mfERG and ffERG electrodiagnostic unit
(EQ390) equipment item.
Response: We did not propose to classify the EQ390 equipment as
highly technical. We note that if we were to use the highly technical
equipment formula for the EQ390 equipment, the total equipment time for
this item would decrease, and we do not believe that this was what the
commenter intended.
After consideration of the public comments, we are finalizing the
work RVUs for the codes in the Electroretinography family of codes as
proposed. We are also finalizing the direct PE inputs as proposed, with
the exception of the CA011 clinical labor activity as described above.
(51) Cardiac Output Measurement (CPT Codes 93561 and 93562)
CPT codes 93561 (Indicator dilution studies such as dye or
thermodilution, including arterial and/or venous catheterization; with
cardiac output measurement) and 93562 (Indicator dilution studies such
as dye or thermodilution, including arterial and/or venous
catheterization; subsequent measurement of cardiac output) were
identified as potentially misvalued on a screen of codes with a
negative IWPUT, with 2016 estimated Medicare utilization over 10,000
for RUC reviewed codes and over 1,000 for Harvard valued and CMS/Other
source codes. The specialty societies noted that CPT codes 93561 and
93562 are primarily performed in the pediatric population, thus the
Medicare utilization for these Harvard-source services is not over
1,000. However, the specialty societies requested and the RUC agreed
that these services should be reviewed under this negative IWPUT
screen.
For CPT code 93561, we disagreed with the RUC-recommended work RVU
of 0.95 and we proposed a work RVU of 0.60 based on a crosswalk to CPT
code 77003 (Fluoroscopic guidance and localization of needle or
catheter tip for spine or paraspinous diagnostic or therapeutic
injection procedures (epidural or subarachnoid)). CPT Code 77003 is
another recently-reviewed add-on global code with the same 15 minutes
of intraservice time and 2 additional minutes of preservice evaluation
time. In our review of CPT code 93561, we found that there was a
particularly unusual relationship between the surveyed work times and
the RUC-recommended work RVU. We noted that the recommended
intraservice time for CPT code 93561 was decreasing from 29 minutes to
15 minutes (48 percent reduction), and the recommended total time for
CPT code 93561 was decreasing from 78 minutes to 15 minutes (81 percent
reduction); however, the recommended work RVU was instead increasing
from 0.25 to 0.95, which is an increase of nearly 300 percent. Although
we did not imply that the decrease in time as reflected in survey
values must equate to a one-to-one or linear decrease in the valuation
of work RVUs, we believe that since the two components of work are time
and intensity, significant decreases in time should typically be
reflected in decreases to work RVUs, not increases in valuation. We
recognized that CPT code 93561 is an unusual case, as it is shifting
from 0-day global status to add-on code status. However, when the work
time for a code is going down and the unit of service is being reduced,
we would not expect to see an increased work RVU under these
circumstances, and especially not such a large work RVU increase.
Therefore, we proposed instead to crosswalk CPT code 93561 to CPT code
77003 at a work RVU of 0.60, which we believe is a more accurate
valuation in relation to other recently-reviewed add-on codes on the
PFS. We believe that this proposed work RVU of 0.60 better preserves
relativity with other clinically similar codes with similar surveyed
work times.
For CPT code 93562, we disagreed with the recommended work RVU of
0.77 and proposed a work RVU of 0.48 based on the intraservice time
ratio with CPT code 93561. We observed a similar pattern taking place
with CPT code 93562 as with the first code in the family, noting that
the recommended intraservice time was decreasing from 16 minutes to 12
minutes (25 percent reduction), and the recommended total time was
decreasing from 44 minutes to

[[Page 59565]]

12 minutes (73 percent reduction); however, the RUC-recommended work
RVU was instead increasing from 0.01 to 0.77. We recognized that CPT
code 93562 is another unusual case, as it is also shifting from 0-day
global status to add-on code status, and the current work RVU of 0.01
is a decrease from the code's former valuation of 0.16 following the
removal of moderate sedation in the CY 2017 rule cycle. However, when
the work time for a code is going down and the unit of service is being
reduced, we typically would not expect to see a work RVU increase under
these circumstances, and especially not such a large work RVU increase.
Therefore, we proposed instead to apply the intraservice time ratio
from CPT code 93561, for a ratio of 0.80 (12 minutes divided by 15
minutes) multiplied by the proposed work RVU of 0.60 for CPT code
93561, which results in the proposed work RVU of 0.48 for CPT code
93562. We noted that the RUC-recommended work values also line up
according to the same intraservice time ratio, with the recommended
work RVU of 0.77 for CPT code 93562 existing in a ratio of 0.81 with
the recommended work RVU of 0.95 for CPT code 93561. We believe that
this provides further rationale for our proposal to value the work RVU
of CPT code 93562 at 80 percent of the work RVU of CPT code 93561.
There are no recommended direct PE inputs for the codes in this
family and we did not propose any direct PE inputs.
The following is a summary of the public comments we received on
our proposals involving the Cardiac Output Measurement family of codes.
Comment: Commenters stated that there were three intertwined flawed
assumptions that CMS considered when proposing values for CPT codes
93561 and 93562, which if finalized would lead to continued
misvaluation of these services. Commenters stated that the first of
these flawed assumptions was a comparison of the survey data to Harvard
data: The current time data for these codes came from the Harvard
studies, has zero validity and should not be used to compare to current
valid survey data. Commenters stated that the second of these flawed
assumptions was a comparison of the recommended physician work RVUs to
old work RVUs: The negative intensity of these codes confirmed that
this previous methodology in which the current work RVU was derived
from is flawed. Commenters stated that the third of these flawed
assumptions was the use of an intraservice time ratio: This
inaccurately treated all components of the physician time as having
identical intensity and is incorrect. Other commenters identified
changes in the global period from 0-day to add-on status and changes in
the patient population from adult patients to pediatric patients as a
rationale for why the increases in valuation were appropriate.
Many commenters disagreed with the proposed work RVU of 0.60 for
CPT code 93561 and stated that CMS should finalize the RUC-recommended
work RVU of 0.95. Commenters disagreed with the CMS crosswalk to CPT
code 77003, stating that it was not a good crosswalk despite having the
same intraservice work time. Commenters stated that CPT code 77003 is
the imaging guidance code for needle placement for the epidural
injection, and that placing a catheter in the heart and lungs of a
child is not merely an imaging procedure. Commenters stated that a more
appropriate injection procedure comparison would be the actual epidural
injection procedure code, CPT code 62320 (Injection(s), of diagnostic
or therapeutic substance(s) (e.g., anesthetic, antispasmodic, opioid,
steroid, other solution), not including neurolytic substances,
including needle or catheter placement, interlaminar epidural or
subarachnoid, cervical or thoracic; without imaging guidance) at a work
RVU of 1.80 or to the top key reference CPT code 93567 (Injection
procedure during cardiac catheterization including imaging supervision,
interpretation, and report; for supravalvular aortography) at a work
RVU of 0.97.
Many commenters also disagreed with the proposed work RVU of 0.48
for CPT code 93562 and stated that CMS should finalize the RUC-
recommended work RVU of 0.77. Commenters stated that using an
incremental approach in lieu of strong crosswalks and input from the
RUC and physicians providing these services was an unfounded
methodology. Commenters stated that CMS should rely on the survey data
instead of the use of an increment, and commenters listed the reference
codes chosen by the RUC which they stated were more appropriate for
valuation.
Response: We appreciate the detailed feedback from the commenters
regarding CPT Codes 93561 and 93562. We agree with the commenters that
the proposed crosswalk to CPT code 77003 would result in an
inappropriately low intensity for CPT code 93561.
After consideration of the public comments, we are finalizing the
RUC-recommended work RVU of 0.95 for CPT code 93561 and the RUC-
recommended work RVU of 0.77 for CPT code 93562. We are also finalizing
our proposal to have no direct PE inputs for these codes.
(52) Coronary Flow Reserve Measurement (CPT Codes 93571 and 93572)
CPT code 93571 (Intravascular Doppler velocity and/or pressure
derived coronary flow reserve measurement (coronary vessel or graft)
during coronary angiography including pharmacologically induced stress;
initial vessel) was identified on a list of all services with total
Medicare utilization of 10,000 or more that have increased by at least
100 percent from 2009 through 2014. CPT code 93572 (Intravascular
Doppler velocity and/or pressure derived coronary flow reserve
measurement (coronary vessel or graft) during coronary angiography
including pharmacologically induced stress; each additional vessel) was
also included for review as part of the same family of CPT codes. The
RUC recommended a work RVU of 1.50 for CPT code 93571, which is lower
than the current work RVU of 1.80. The total time for this service
decreased by 5 minutes from 20 minutes to 15 minutes. The RUC's
recommendation is based on a crosswalk to CPT code 15136 (Dermal
autograft, face, scalp, eyelids, mouth, neck, ears, orbits, genitalia,
hands, feet, and/or multiple digits; each additional 100 sq cm, or each
additional 1% of body area of infants and children, or part thereof),
which has an identical intraservice and total time as CPT code 93571 of
15 minutes.
We disagreed with the recommended work RVU of 1.50 for this CPT
code because we did not believe that a reduction in work RVU from 1.80
to 1.50 was commensurate with the reduction in time for this service of
5 minutes. Using the building block methodology, we believed the work
RVU for CPT code 93571 should be 1.35. We believe that a crosswalk to
CPT code 61517 (Implantation of brain intracavitary chemotherapy agent
(List separately in addition to CPT code for primary procedure)) with a
work RVU of 1.38 was more appropriate because it has an identical
intraservice and total time (15 minutes) as CPT code 93571, described
work that is similar, and was closer to the calculations for
intraservice time ratio, total time ratio, and the building block
method. Therefore, we proposed a work RVU of 1.38 for CPT code 93571.
We proposed the RUC-recommended work RVU for CPT code 93572
(Intravascular Doppler velocity and/or pressure derived coronary flow
reserve measurement (coronary vessel or graft)

[[Page 59566]]

during coronary angiography including pharmacologically induced stress;
each additional vessel) of 1.00.
Both of these codes are facility-only procedures with no
recommended direct PE inputs.
The following is a summary of the public comments we received on
our proposals involving the Coronary Flow Reserve Measurement family of
codes.
Comment: We received several comments regarding our proposed work
RVU of 1.38 for CPT 93571. Commenters generally did not agree with the
use of time based metrics in our assessment of the work RVU for this
code. In particular, they opposed CMS's reduction of work RVUs in
proportion to the total reduction in time for furnishing this service.
This methodology, they maintain, ignores the fact that the time
reduction of 5 minutes in furnishing this service is associated with
the low intensity portion of the work.
Response: We do not agree that a reduction in work RVU proportional
to the total time decrease for this code, which has essentially only
one time parameter since the intraservice time and total time are the
same, is not appropriate. We continue to believe that this calculated
value of 1.35 (a 75 percent reduction in both time and work RVU)
accounts more appropriately for the reduction in time for a service in
which the work to perform the service has not changed. We therefore
continue to believe that our crosswalk to CPT code 61517 is similar in
both work and time to CPT code 93571, and we are finalizing our
proposed work RVU for CPT code 93571 of 1.38.
Comment: We received support from commenters regarding our proposed
work RVU of 1.00 for CPT code 93572.
Response: We appreciate the support and are finalizing a work RVU
of 1.00 for CPT code 93572 as proposed.
After consideration of the public comments, we are finalizing the
work RVUs for the codes in the Coronary Flow Reserve Measurement family
of codes as proposed.
(53) Peripheral Artery Disease (PAD) Rehabilitation (CPT Code 93668)
During 2017, we issued a national coverage determination (NCD) for
Medicare coverage of supervised exercise therapy (SET) for the
treatment of peripheral artery disease (PAD). Previously, the service
had been assigned noncovered status under the PFS. CPT code 93668
(Peripheral arterial disease (PAD) rehabilitation, per session) was
payable before the end of CY 2017, retroactive to the effective date of
the NCD (May 25, 2017), and for CY 2018, CMS made payment for Medicare-
covered SET for the treatment of PAD, consistent with the NCD, reported
with CPT code 93668. We used the most recent RUC-recommended work and
direct PE inputs and requested that the RUC review the service, which
had not been reviewed since 2001, for direct PE inputs. The RUC did not
recommend a work RVU for CPT code 93668 due to the belief that there is
no physician work involved in this service. After reviewing this code,
we proposed a work RVU of 0.00 for CPT code 93668 and proposed to
continue valuing the code for PE only.
The following is a summary of the public comments we received on
our proposals involving CPT code 93688.
Comment: Commenters were supportive of our proposal of the RUC-
recommended work RVUs and PE inputs.
Response: We thank commenters for their support.
Comment: Several commenters noted that the proposed reductions in
payment would impact their ability to perform the service in an office
setting and that this would force them to perform the service in a
hospital setting. They further noted that this would ultimately
increase costs and impact patient satisfaction as well as impact their
ability to provide the service to rural and under insured patients.
Response: We appreciate the feedback these commenters provided. We
note that we accepted the RUC-recommended work RVU of 0.00 and the RUC-
recommended direct PE inputs without refinements for CPT code 93668. We
further note that the RUC has generally provided recommendations on
work, work time, and direct PE inputs. We do not believe that the work
or direct PE inputs assigned to these services are inaccurate. We
further note that if commenters believe an additional RUC review would
serve to address the issues they identified in our proposal, we would
consider this information or recommendations from other interested
stakeholders for future rulemaking.
After consideration of the public comments received, we are
finalizing the RUC-recommended work RVUs and direct PE inputs for CPT
code 93668 as proposed.
(54) Home Sleep Apnea Testing (CPT Codes 95800, 95801, and 95806)
CPT codes 95800 (Sleep study, unattended, simultaneous recording;
heart rate, oxygen saturation, respiratory analysis (e.g., by airflow
or peripheral arterial tone), and sleep time), 95801 (Sleep study,
unattended, simultaneous recording; minimum of heart rate, oxygen
saturation, and respiratory analysis (e.g., by airflow or peripheral
arterial tone)), and 95806 (Sleep study, unattended, simultaneous
recording of, heart rate, oxygen saturation, respiratory airflow, and
respiratory effort (e.g., thoracoabdominal movement)) were flagged by
the CPT Editorial Panel and reviewed at the October 2014 Relativity
Assessment Workgroup meeting. Due to rapid growth in service volume,
the RUC recommended that these services be reviewed after 2 more years
of Medicare utilization data (2014 and 2015 data). These three codes
were surveyed for the April 2017 RUC meeting and new recommendations
for work and direct PE inputs were submitted to CMS.
For CPT code 95800, the RUC recommended a work RVU of 1.00 based on
the survey 25th percentile value. We disagreed with the recommended
value and proposed a work RVU of 0.85 based on a pair of crosswalk
codes: CPT code 93281 (Programming device evaluation (in person) with
iterative adjustment of the implantable device to test the function of
the device and select optimal permanent programmed values with
analysis, review and report by a physician or other qualified health
care professional; multiple lead pacemaker system) and CPT code 93260
(Programming device evaluation (in person) with iterative adjustment of
the implantable device to test the function of the device and select
optimal permanent programmed values with analysis, review and report by
a physician or other qualified health care professional; implantable
subcutaneous lead defibrillator system). Both of these codes have a
work RVU of 0.85, as well as having the same intraservice time of 15
minutes, similar total times to CPT code 95800, and recent review dates
within the last few years.
In reviewing CPT code 95800, we noted that the recommended
intraservice time is decreasing from 20 minutes to 15 minutes (25
percent reduction), and the recommended total time is decreasing from
50 minutes to 31 minutes (38 percent reduction); however, the RUC-
recommended work RVU is only decreasing from 1.05 to 1.00, which is a
reduction of less than 5 percent. Although we did not imply that the
decrease in time as reflected in survey values must equate to a one-to-
one or linear decrease in the valuation of work RVUs, we believe that
since the two components of work are time and intensity, significant
decreases in time should be reflected in decreases to work RVUs. In the
case of CPT code 95800, we believe that it would be more accurate to
propose a work RVU of 0.85

[[Page 59567]]

based on the aforementioned crosswalk codes to account for these
decreases in the surveyed work time. We also noted that in this case
where the surveyed times are decreasing and the utilization of CPT code
95800 is increasingly significantly (quadrupling in the last 5 years),
we had reason to believe that practitioners are becoming more efficient
at performing the procedure, which, under the resource-based nature of
the RVU system, lends further support for a reduction in the work RVU.
For CPT code 95801, the RUC proposed a work RVU of 1.00 again based
on the survey 25th percentile. We disagreed with the recommended value
and we proposed a work RVU of 0.85 based on the same pair of crosswalk
codes, CPT codes 93281 and 93260. We noted that CPT codes 95800 and
95801 had identical recommended work RVUs and identical recommended
survey work times. Given that these two codes also have extremely
similar work descriptors, we interpreted this to mean that the two
codes could have the same work RVU, and therefore, we proposed the same
work RVU of 0.85 for both codes.
For CPT code 95806, the RUC recommended a work RVU of 1.08 based on
a crosswalk to CPT code 95819 (Electroencephalogram (EEG); including
recording awake and asleep). Although we disagreed with the RUC-
recommended work RVU of 1.08, we concurred that the relative difference
in work between CPT codes 95800 and 95801 and CPT code 95806 was
equivalent to the recommended interval of 0.08 RVUs. Therefore, we
proposed a work RVU of 0.93 for CPT code 95806, based on the
recommended interval of 0.08 additional RVUs above our proposed work
RVU of 0.85 for CPT codes 95800 and 95801. We also noted that CPT code
95806 is experiencing a similar change in the recommended work and time
values comparable to CPT code 95800. The recommended intraservice time
for CPT code 95806 is decreasing from 25 minutes to 15 minutes (40
percent), and the recommended total time is decreasing from 50 minutes
to 31 minutes (38 percent); however, the recommended work RVU is only
decreasing from 1.25 to 1.08, which is a reduction of only 14 percent.
As we stated for CPT code 95800, we do not believe that decreases in
work time must equate to a one-to-one or linear decrease in the
valuation of work RVUs, but we do believe that these changes in
surveyed work time suggest that practitioners are becoming more
efficient at performing the procedure, and that it would be more
accurate to maintain the recommended work interval with CPT codes 95800
and 95801 by proposing a work RVU of 0.93 for CPT code 95806.
We did not propose any direct PE refinements for this code family.
The following is a summary of the public comments we received on
our proposals involving the Home Sleep Apnea Testing family of codes.
Comment: One commenter stated that the obesity epidemic has
contributed to the rising prevalence of obstructive sleep apnea, and
sleep centers have already worked to reduce costs in diagnosis of
obstructive sleep apnea by utilizing out-of-center, or home, sleep
apnea testing. The commenter stated that further reduction in work
RVUs, and hence payments for home sleep apnea testing services, may
endanger the sustainability of sleep centers to provide this service to
Medicare beneficiaries and may thus deny beneficiaries access to
testing for obstructive sleep apnea. A different commenter stated that
a reduction in work RVUs for home sleep apnea testing services will
discourage vendors from producing technically better home sleep apnea
testing devices and software.
Response: We agree with the commenter regarding the importance of
sleep centers in helping to diagnose and treat the occurrence of
obstructive sleep apnea. However, we remind the commenter that we are
obligated under the statute to consider both time and intensity in
establishing work RVUs for PFS services. As explained in the CY 2017
PFS final rule (81 FR 80272 through 80277), we recognize that adjusting
work RVUs for changes in time is not always a straightforward process,
so we have applied various methodologies to identify several potential
work values for individual codes. When the recommended work RVUs do not
appear to account for significant changes in time, we have employed the
different approaches to identify potential values that reconcile the
recommended work RVUs with the recommended time values. For the codes
in the Home Sleep Apnea Testing family, we believe that the decreases
in the surveyed work times should be reflected in decreases to the work
RVUs.
Comment: Many commenters disagreed with the proposed work RVU of
0.85 for CPT codes 95800 and 95801, and stated that CMS should finalize
the RUC-recommended work RVU of 1.00 for these services. Commenters
stated that it was unclear why CMS chose to employ the crosswalk to CPT
codes 93281 and 93260, which the commenters stated were not at all
similar to the home sleep apnea test codes and are cardiovascular
implantable recording device codes, not diagnostic studies.
Response: We continue to believe that the nature of the PFS
relative value system is such that all services are appropriately
subject to comparisons to one another. Although codes with clinically
similar services are sometimes stronger comparator codes, we do not
agree that codes must both constitute diagnostic studies to be used as
a crosswalk. In the case of our specific crosswalk to CPT codes 93281
and 93260, we noted in the proposed rule that both of these codes have
a work RVU of 0.85, as well as having the same intraservice time of 15
minutes and similar total times to CPT codes 95800 and 95801, and
recent review dates within the last few years.
Comment: Several commenters stated that the existing times for CPT
codes 95800 and 95801 were likely an overestimate due to the lack of
experience providing these services when they were first valued as new
codes in April 2010. Commenters stated that physicians are now more
familiar with home sleep apnea testing and the new survey times were
more reflective of this family of services.
Response: This information from the commenters appears to suggest
that the current work RVUs for CPT codes 95800 and 95801 are also
overestimates. If practitioners have become more familiar and efficient
in the practice of home sleep apnea testing, we believe that the work
RVUs should also be decreased to reflect the fact that the procedures
can now be performed faster. We remind the commenters that we are
obligated under the statute to consider both time and intensity in
establishing work RVUs for PFS services, and we have no reason to
believe that the intensity of these procedures has increased to the
point of offsetting these gains in time efficiency.
Comment: Several commenters stated that, despite the fact that we
indicated we did not intend to imply that the decrease in time should
equate to a linear decrease in the valuation of work RVUs, this seems
to be the approach taken in the proposed rule. Commenters stated that
modifications to work RVUs should be based on empirical evidence,
gathered through the survey process, which takes into consideration the
amount of time required to provide a service as well as the complexity
and intensity of each service.
Response: We disagree with the commenters, and we note that the
proposed work RVUs for both CPT codes 95800 and 95801 were not based on
pure time ratios on a one-to-one or linear basis. For CPT code 95800,
use of

[[Page 59568]]

the intraservice time ratio alone would have yielded a work RVU of 0.79
and the total time ratio would have yielded a work RVU of 0.65. For CPT
code 95801, use of the intraservice time ratio would have yielded a
work RVU of 1.00 and the total time ratio would have yielded a work RVU
of 0.78. We did not propose these values and instead proposed a work
RVU of 0.85 for both codes specifically because the consideration of
time ratios is only one component of our review process. We believe
that our proposed work RVU of 0.85 for these services based on a pair
of crosswalk codes, CPT codes 93281 and 93260 is appropriate, and note
that we recognized that the use of pure time ratios at a one-to-one or
linear basis would not accurately capture the changes in work taking
place in these codes since their last valuation.
Comment: Many commenters disagreed with the proposed work RVU of
0.93 for CPT code 95806, and stated that CMS should finalize the RUC-
recommended work RVU of 1.08. Commenters stated that the survey process
values a service compared to other similar services, and that using an
incremental approach in lieu of strong crosswalks and input from the
RUC and physicians providing these services was unfounded.
Response: We believe the use of an incremental difference between
codes is a valid methodology for setting values, especially in valuing
services within a family of revised codes where it is important to
maintain appropriate intra-family relativity. Historically, we have
frequently utilized an incremental methodology in which we value a code
based upon its incremental difference between another code or another
family of codes. We note that the RUC has also used the same
incremental methodology on occasion when it was unable to produce valid
survey data for a service. We continue to believe that the proposed
work RVU of 0.93 would be the most accurate valuation for CPT code
95806.
Comment: Several commenters stated that CPT code 95806 has become a
more complex study and requires more time as well as greater levels of
skill and training to perform the interpretation for this study.
Commenters stated that more complex patients with a wider variety of
sleep problems and more severe conditions are being studied with this
modality, which means that the skills and continuing updates to
education required to interpret these studies have dramatically
increased.
Response: We agree with the commenters that due to the decreasing
surveyed work times and rapidly increasing utilization for these codes,
we had reason to believe that practitioners are becoming more efficient
at performing the procedure. While the incorporation of new technology
can sometimes make services more complex and difficult to perform, it
can also have the opposite effect by making services less reliant on
manual skill and technique. We do not agree with the commenter that the
need for additional training to use the equipment would necessarily be
grounds for an increase in the work RVU, as improvements in technology
are commonplace across many different services and are not specific to
this procedure. As detailed above, we also have reason to believe that
the improved technology has led to greater efficiencies in the
procedure which, under the resource-based nature of the RVU system,
lends further support for a reduction in the work RVU.
After consideration of the public comments, we are finalizing the
work RVUs and the direct PE inputs for the codes in the Home Sleep
Apnea Testing family of codes as proposed.
(55) Neurostimulator Services (CPT Codes 95970, 95976, 95977, 95983,
and 95984)
In October 2013, CPT code 95971 (Electronic analysis of implanted
neurostimulator pulse generator system; simple spinal cord, or
peripheral (i.e., peripheral nerve, sacral nerve, neuromuscular)
neurostimulator pulse generator/transmitter, with intraoperative or
subsequent programming) was identified in the second iteration of the
High Volume Growth screen. In January 2014, the RUC recommended that
CPT codes 95971, 95972 (Electronic analysis of implanted
neurostimulator pulse generator system; complex spinal cord, or
peripheral (i.e., peripheral nerve, sacral nerve, neuromuscular)
(except cranial nerve) neurostimulator pulse generator/transmitter,
with intraoperative or subsequent programming) and 95974 (Electronic
analysis of implanted neurostimulator pulse generator system; complex
cranial nerve neurostimulator pulse generator/transmitter, with
intraoperative or subsequent programming, with or without nerve
interface testing, first hour) be referred to the CPT Editorial Panel
to address the entire family regarding the time referenced in the CPT
code descriptors. In June 2017, the CPT Editorial Panel revised CPT
codes 95970, 95971, and 95972, deleted CPT codes 95974, 95975
(Electronic analysis of implanted neurostimulator pulse generator
system; complex cranial nerve neurostimulator pulse generator/
transmitter, with intraoperative or subsequent programming, each
additional 30 minutes after first hour), 95978 (Electronic analysis of
implanted neurostimulator pulse generator system, complex deep brain
neurostimulator pulse generator/transmitter, with initial or subsequent
programming; first hour), and 95979 (Electronic analysis of implanted
neurostimulator pulse generator system, complex deep brain
neurostimulator pulse generator/transmitter, with initial or subsequent
programming; each additional 30 minutes after first hour) and created
four new CPT codes for analysis and programming of implanted cranial
nerve neurostimulator pulse generator, analysis, and programming of
brain neurostimulator pulse generator systems and analysis of stored
neurophysiology recording data.
The RUC recommended a work RVU of 0.45 for CPT code 95970
(Electronic analysis of implanted neurostimulator pulse generator/
transmitter (e.g., contact group(s),interleaving, amplitude, pulse
width, frequency (Hz), on/off cycling, burst, magnet mode, dose
lockout, patient selectable parameters, responsive neurostimulation,
detection algorithms, closed loop parameters, and passive parameters by
physician or other qualified health care professional; with brain,
cranial nerve, spinal cord, peripheral nerve, or sacral nerve
neurostimulator pulse generator/transmitter, without programming)),
which is identical to the current work RVU for this CPT code. The
descriptor for this CPT code has been modified slightly, but the
specialty societies affirmed that the work itself has not changed. To
justify its recommendation, the RUC provided two references: CPT code
62368 (Electronic analysis of programmable, implanted pump for
intrathecal or epidural drug infusion (includes evaluation of reservoir
status, alarm status, drug prescription status); with reprogramming),
with intraservice time of 15 minutes, total time of 27 minutes, and a
work RVU of 0.67; and CPT code 99213 (Office or other outpatient visit
for the evaluation and management of an established patient, which
requires at least 2 of these 3 key components: An expanded problem
focused history; An expanded problem focused examination; or Medical
decision making of low complexity. Counseling and coordination of care
with other physicians, other qualified health care professionals, or
agencies are provided consistent with the nature of the problem(s) and
the patient's and/or family's needs. Usually, the

[[Page 59569]]

presenting problem(s) are of low to moderate severity. Typically, 15
minutes are spent face-to-face with the patient and/or family), with
intraservice time of 15 minutes, total time of 23 minutes, and a work
RVU of 0.97.
We disagreed with the RUC's recommendation because we did not
believe that maintaining the work RVU, given a decrease of four minutes
in total time, was appropriate. In addition, we noted that the
reference CPT codes chosen have much higher intraservice and total
times than CPT code 95970, and also have higher work RVUs, making them
poor comparisons. Instead, we identified a crosswalk to CPT code 95930
(Visual evoked potential (VEP) checkerboard or flash testing, central
nervous system except glaucoma, with interpretation and report) with 10
minutes intraservice time, 14 minutes total time, and a work RVU of
0.35. Therefore, we proposed a work RVU of 0.35 for CPT code 95970.
CPT code 95976 (Electronic analysis of implanted neurostimulator
pulse generator/transmitter (e.g., contact group(s), interleaving,
amplitude, pulse width, frequency (Hz), on/off cycling, burst, magnet
mode, dose lockout, patient selectable parameters, responsive
neurostimulation, detection algorithms, closed loop parameters, and
passive parameters) by physician or other qualified health care
professional; with simple cranial nerve neurostimulator pulse
generator/transmitter programming by physician or other qualified
health care professional) is a new CPT code replacing CPT code 95974
(Electronic analysis of implanted neurostimulator pulse generator
system (e.g., rate, pulse amplitude, pulse duration, configuration of
wave form, battery status, electrode selectability, output modulation,
cycling, impedance and patient compliance measurements); complex
cranial nerve neurostimulator pulse generator/transmitter, with
intraoperative or subsequent programming, with or without nerve
interface testing, first hour). The description of the work involved in
furnishing CPT code 95976 differs from that of the deleted CPT code in
a few important ways, notably that the time parameter has been removed
so that the CPT code no longer describes the first hour of programming.
In addition, the new CPT code refers to simple rather than complex
programming. Accordingly, the intraservice and total times for this CPT
code are substantively different from those of the deleted CPT code.
CPT code 95976 has an intraservice time of 11 minutes and a total time
of 24 minutes, while CPT code 95974 has an intraservice time of 60
minutes and a total time of 110 minutes. The RUC recommended a work RVU
of 0.95 for CPT code 95976. The RUC's top reference CPT code as chosen
by the RUC survey participants was CPT code 95816 (Electroencephalogram
(EEG); including recording awake and drowsy), with an intraservice time
of 15 minutes, 26 minutes total time, and a work RVU of 1.08. The RUC
indicated that the service is similar, but somewhat more complex than
CPT code 95976.
We disagreed with the RUC's recommended work RVU for this CPT code
because we did not believe that the large difference in time between
the new CPT code and CPT code 95974 was reflected in the slightly
smaller proportional decrease in work RVUs. The reduction in total
time, from 110 minutes to 24 minutes is nearly 80 percent. However, the
RUC's recommended work RVU reflects a reduction of just under 70
percent. We believe that a more appropriate crosswalk would be CPT code
76641 (Ultrasound, breast, unilateral, real time with image
documentation, including axilla when performed; complete) with
intraservice time of 12 minutes, total time of 22 minutes, and a work
RVU of 0.73. Therefore, we proposed a work RVU of 0.73 for CPT code
95976.
CPT code 95977 describes the same work as CPT code 95976, but with
complex rather than simple programming. The CPT Editorial Panel refers
to simple programming of a neurostimulator pulse generator/transmitter
as the adjustment of one to three parameter(s), while complex
programming includes adjustment of more than three parameters. For
purposes of applying the building block methodology and calculating
intraservice and total time ratios, the RUC compared CPT code 94X84
with CPT code 95975 (Electronic analysis of implanted neurostimulator
pulse generator system (e.g., rate, pulse amplitude, pulse duration,
configuration of wave form, battery status, electrode selectability,
output modulation, cycling, impedance and patient compliance
measurements); complex cranial nerve neurostimulator pulse generator/
transmitter, with intraoperative or subsequent programming, each
additional 30 minutes after first hour), which is being deleted by the
CPT Editorial Panel. We believe that this was an inappropriate
comparison since it is time based (first hour of programming) and is an
add-on code. Instead we believe that the RUC intended to compare CPT
code 95977 with CPT code 95974 (Electronic analysis of implanted
neurostimulator pulse generator system (e.g., rate, pulse amplitude,
pulse duration, configuration of wave form, battery status, electrode
selectability, output modulation, cycling, impedance and patient
compliance measurements); complex cranial nerve neurostimulator pulse
generator/transmitter, with intraoperative or subsequent programming,
with or without nerve interface testing, first hour), which has been
recommended for deletion by the CPT Editorial Panel and is also the
comparison for CPT code 95976. The RUC recommended a work RVU of 1.19
for CPT code 95977. The RUC disagreed with the two top reference
services CPT code 99215 (Office or other outpatient visit for the
evaluation and management of an established patient, which requires at
least 2 of these 3 key components: A comprehensive history; A
comprehensive examination; or Medical decision making of high
complexity. Counseling and/or coordination of care with other
physicians, other qualified health care professionals, or agencies are
provided consistent with the nature of the problem(s) and the patient's
and/or family's needs. Usually, the presenting problem(s) are of
moderate to high severity. Typically, 40 minutes are spent face-to-face
with the patient and/or family) and CPT code 99202 (Office or other
outpatient visit for the evaluation and management of a new patient,
which requires these 3 key components: An expanded problem focused
history; an expanded problem focused examination; or straightforward
medical decision making. Counseling and/or coordination of care with
other physicians, other qualified health care professionals, or
agencies are provided consistent with the nature of the problem(s) and
the patient's and/or family's needs. Usually, the presenting problem(s)
are of low to moderate severity. Typically, 20 minutes are spent face-
to-face with the patient and/or family) and instead compared CPT code
95977 to CPT code 99308 (Subsequent nursing facility care, per day, for
the evaluation and management of a patient, which requires at least 2
of these 3 key components: An expanded problem focused interval
history; An expanded problem focused examination; or Medical decision
making of low complexity. Counseling and/or coordination of care with
other physicians, other qualified health care professionals, or
agencies are provided consistent with the nature of the problem(s) and
the patient's and/or family's needs. Usually, the patient is responding
inadequately to therapy or has developed a minor complication.

[[Page 59570]]

Typically, 15 minutes are spent at the bedside and on the patient's
facility floor or unit.) with total time of 31 minutes, intraservice
time of 15 minutes, and a work RVU of 1.16; and CPT code 12013 (Simple
repair of superficial wounds of face, ears, eyelids, nose, lips and/or
mucous membranes; 2.6 cm to 5.0 cm), with total time of 27 minutes,
intraservice time of 15 minutes, and a work RVU of 1.22.
We disagreed with the RUC's recommended work RVU of 1.19 for CPT
code 95977. Once the comparison CPT code is corrected to CPT code
95974, the reverse building block calculation indicates that a lower
work RVU (close to 0.82) would be a better reflection of the work
involved in furnishing this service. As an alternative to the RUC's
recommendation, we added the difference in RUC-recommended work RVUs
between CPT codes 95976 and 95977 (0.24 RVUs) to the proposed work RVU
of 0.73 for CPT code 95976. Therefore, we proposed a work RVU of 0.97
for CPT code 95977.
CPT code 95983 (Electronic analysis of implanted neurostimulator
pulse generator/transmitter (e.g., contact group(s), interleaving,
amplitude, pulse width, frequency (Hz), on/off cycling, burst, magnet
mode, doe lockout, patient selectable parameters, responsive
neurostimulation, detection algorithms, closed loop parameters, and
passive parameters) by physician or other qualified health care
professional; with brain neurostimulator pulse generator/transmitter
programming, first 15 minutes face-to-face time with physician or other
qualified health care professional) is the base code for add-on CPT
code 95984 (Electronic analysis of implanted neurostimulator pulse
generator/transmitter (e.g., contact group(s), interleaving, amplitude,
pulse width, frequency (Hz), on/off cycling, burst, magnet mode, doe
lockout, patient selectable parameters, responsive neurostimulation,
detection algorithms, closed loop parameters, and passive parameters)
by physician or other qualified health care professional; with brain
neurostimulator pulse generator/transmitter programming, each
additional 15 minutes face-to-face time with physician or other
qualified health care professional), which is an add-on CPT code and
can only be billed with CPT code 95983. The RUC compared CPT code 95983
with CPT code 95978 (Electronic analysis of implanted neurostimulator
pulse generator system (e.g., rate, pulse amplitude and duration,
battery status, electrode selectability and polarity, impedance and
patient compliance measurements), complex deep brain neurostimulator
pulse generator/transmitter, with initial or subsequent programming;
first hour), which the CPT Editorial Panel is recommending for
deletion. The primary distinction between the new and old CPT codes is
that the new CPT code describes the first 15 minutes of programming
while the deleted CPT code describes up to one hour of programming. The
RUC recommended a work RVU of 1.25 for CPT code 95983 and a work RVU of
1.00 for CPT code 95984. For CPT code 95983, the RUC's recommendation
is based on reference CPT codes 12013 (Simple repair of superficial
wounds of face, ears, eyelids, nose, lips and/or mucous membranes; 2.6
cm to 5.0 cm), with total time of 27 minutes, intraservice time of 15
minutes, and a work RVU of 1.22; and CPT code 70470 (Computed
tomography, head or brain; without contrast material, followed by
contrast material(s) and further sections) with 25 minutes of total
time, 15 minutes of intraservice time, and a work RVU of 1.27.
We disagreed with the RUC's recommended work RVU for CPT code 95983
because we did not believe that the reduction in work RVU reflected the
change in time described by the CPT code. Using the reverse building
block methodology, we estimated that a work RVU of nearer to 1.11 would
be more appropriate. In addition, if we were to sum the RUC-recommended
RVUs for a single hour of programming using one of the base CPT codes
and three of the 15 minute follow-on CPT codes, 1 hour of programming
would be valued at 4.25 work RVUs. This contrasts sharply from the work
RVU of 3.50 for 1 hour of programming using the deleted CPT code 95978.
We believe that a more appropriate valuation of the work involved in
furnishing this service is reflected by a crosswalk to CPT code 93886
(Transcranial Doppler study of the intracranial arteries; complete
study), with total time 27 minutes, intraservice time of 17 minutes,
and a work RVU of 0.91. Therefore, we proposed a work RVU of 0.91 for
CPT code 95983.
The RUC's recommended work RVU of 1.00 for CPT code 95984 is based
on the key reference service CPT code 64645 (Chemodenervation of one
extremity; each additional extremity, 5 or more muscles), which has
total time of 26 minutes, intraservice time of 25 minutes, and a work
RVU 1.39. This new CPT code is replacing CPT code 95978 (Electronic
analysis of implanted neurostimulator pulse generator system (e.g.,
rate, pulse amplitude and duration, battery status, electrode
selectability and polarity, impedance and patient compliance
measurements), complex deep brain neurostimulator pulse generator/
transmitter, with initial or subsequent programming; first hour), which
is being deleted by the CPT Editorial Panel. If we were to add the
incremental difference between CPT codes 95983 and 95984 to the
proposed value for the base CPT code (95983, work RVU = 0.91), we
estimated that this add-on CPT code would have a work RVU of 0.75. The
building block methodology results in a recommendation of a slightly
higher work RVU of 0.82. We proposed a work RVU of 0.80 for CPT code
95984, which falls between the calculated value using incremental
differences and the calculation from the reverse building block, and is
supported by a crosswalk to CPT code 51797 (Voiding pressure studies,
intra-abdominal (ie, rectal, gastric, intraperitoneal)), which is an
add-on CPT code with identical total and intraservice times (15
minutes) as CPT code 95984.
We did not propose any direct PE refinements for this code family.
The following is a summary of the public comments we received on
our proposals involving the Neurostimulator Services family of codes.
Comment: We received a number of comments regarding our proposed
work RVUs for CPT codes 95970, 95976, 95977, 95983, and 95984.
Commenters suggested that CMS misunderstood the role of reference codes
in the RUC's process, and that CMS should not be comparing the times
for the surveyed code to the reference codes because they are not
specifically intended to match in time.
Response: We appreciate the opportunity to clarify that we do not
believe the reference codes provided by the RUC in the summary
documents are being provided as a crosswalk. We did not state that we
thought the two top reference codes, CPT code 62368 (total time of 27
minutes) and CPT code 99213 (total time of 23 minutes) were being used
by the RUC as crosswalk codes (as that term is used in the RUC
process). Instead, we pointed out that the two reference codes are
generally not a particularly good comparison for a survey code with 15
minutes of total time. We understand that survey respondents, not the
RUC, chose the reference codes, and that survey respondents do not have
the physician times readily available when choosing from among services
that they are familiar with. Nonetheless, we expect reference codes to
generally have physician work times that are more similar to the survey
code than an 80 percent difference (in the case of CPT

[[Page 59571]]

code 62368). When we make such an observation with regard to the times
for reference codes in relation to a survey code, we are not
disregarding parameters other than time. We also note that the RUC
compares reference codes in terms of time or intensity relative to the
survey code as a matter of common practice. We understand those
comparisons to be intended by the RUC as one of several dimensions of a
code's work RVU valuation.
As we have stated in the past, we believe that practitioners become
more efficient at furnishing some services over time, shortening the
amount of clinical time required. We still believe this is the case
with regard to CPT code 95970, which has decreased in time without a
significant change in intensity. We maintain that our crosswalk to CPT
code 95930 with a work RVU of 0.35 for this CPT code is appropriate.
Comment: A commenter stated that, since CMS acknowledges that CPT
code 95976 is different from CPT code 95974, which is being deleted,
CMS should not compare the two codes for purpose of evaluating whether
the decreased work time in the new code is appropriate in relation to
the work involved in furnishing CPT code 95930. The commenter urged CMS
to finalize the work RVU proposed by the RUC, which is 0.95.
Response: The major difference in the description of work involved
in furnishing CPT code 95974 and CPT code 95976 involves a change from
`complex' to `simple' programming. We do not believe that this change,
which indicates a lower level of intensity for new CPT code 95976 than
for deleted CPT code 95974, precludes us from using the deleted CPT
code as the basis for evaluating whether the comparatively lower time
involved in furnishing CPT code 95976 is adequately reflected by the
RUC-recommended work RVU for this new CPT code. We continue to believe
that the lower time in furnishing the work described by CPT code 95976,
compared with the time in furnishing the service described by deleted
CPT code 95974, should result in a lower work RVU than the value
recommended by the RUC. Therefore, we are finalizing the work RVU for
CPT code 95976 of 0.73 based on a crosswalk to CPT code 76641.
Comment: A commenter clarified that we incorrectly stated that the
RUC compared the new CPT code 95977 with deleted CPT code 95975, which
is an add-on code and would therefore not be an acceptable point of
comparison.
Response: We appreciate the commenter informing us of the error and
we agree that the RUC did not compare CPT code 95977 with the deleted
code, CPT code 95975. Instead, the RUC compared the new code with
several other codes: CPT code 99308 (Subsequent nursing facility care,
per day, for the evaluation and management of a patient) with a work
RVU of 1.16, 15 minutes of intra-service time and 31 minutes total time
and CPT code 12013 (Simple repair of superficial wounds of face, ears,
eyelids, nose, lips and/or mucous membranes; 2.6 cm to 5.0 cm) with a
work RVU of 1.22, 15 minutes of intra-service time and 27 minutes total
time. The RUC also cited the following two CPT codes for support: CPT
code 93975 (Duplex scan of arterial inflow and venous outflow of
abdominal, pelvic, scrotal contents and/or retroperitoneal organs;
complete study) with a work RVU of 1.16, 20 minutes of intra-service
time and 30 minutes total time, and 67810 (Incisional biopsy of eyelid
skin including lid margin), with a work RVU of 1.18, 13 minutes of
intra-service time and 27 minutes total time. Despite having cited
these numerous CPT codes as support for their recommended work RVU for
CPT code 95977, we do not see why CPT code 95974 is not an entirely
appropriate point of comparison for CPT code 95977 as we explained in
making our proposal. The only difference between new CPT code 95977 and
new CPT code 95976 is complex vs. simple programming and, since as we
explained in response to comments above, we believe it is appropriate
to use the deleted CPT code 95974 for a time comparison with CPT code
95976, we believe that code is equally valid as the basis for
comparison to CPT code 95977. The building block methodology between
CPT code 95977 and CPT code 95974 suggests that a work RVU in the area
of 0.82 would better reflect both the time and intensity of furnishing
this service. In identifying a more appropriate work RVU, we looked at
the difference in the RUC-recommended work RVU between CPT codes 95976
and 95977, which differ by simple vs. complex programming, and added
the increment to our proposed value for CPT code 95976. We continue to
believe the use of an incremental difference between codes is a valid
methodology for setting values, especially in valuing services within a
family of revised codes where it is important to maintain appropriate
intra-family relativity. Given that we are finalizing our proposed work
RVU for CPT code 95976 of 0.73, we believe a work RVU of 0.97 for CPT
code 95977 is appropriate. We are finalizing a work RVU of 0.97 for CPT
code 95977 as proposed.
Comment: A commenter expressed opposition to our use of the reverse
building block methodology to evaluate the RUC-recommended work RVU for
CPT code 95983 and to identify possible alternative crosswalk CPT
codes. Consequently, the commenter stated that our crosswalk of CPT
code 93886 is based on invalid reasoning about how the time parameter
factors into the code valuation. The work involved in furnishing the
service described by the crosswalk code, according to the commenter, is
less intense than the work described by the survey code.
Response: We disagree with the commenter that the reverse building
block methodology not an appropriate approach to assessing whether the
RUC-recommended work RVU for a code is appropriate. We employed a
reverse building block methodology to assess the reasonableness of the
RUC's recommendation, not to value the code in the first instance. As
the commenter noted, the work described by new CPT code 95983 is
difficult to value in relation to both the deleted code and other codes
on the fee schedule because of the 15 minute time parameter. However,
having looked carefully at the work involved in furnishing the service
described by our crosswalk code, CPT code 93886, we do not believe it
is less intense than the survey code. The service described by CPT code
93886 is performed on patients with recent brain hemorrhage, which we
believe is as complex to study as the work involved in programming
adjustments to multiple parameters in real time. We continue to believe
that CPT code 93886 is an appropriate crosswalk for CPT code 95983, and
we are finalizing a work RVU for this code of 0.91.
Comment: A commenter stated that our approach for valuing CPT code
95984 ignored physician work intensity and complexity in favor of a
random calculation involving code increments, which is a flawed
methodology. CMS's choice of crosswalk code, according to the
commenter, is invalid because it is based on this incorrect approach.
Response: We disagree that the use of incremental differences in
work RVU between codes that have an established pattern of intensity or
time, is inappropriate. We remind the commenter that our calculation of
increments is based on the RUC's recommended work RVUs for the relevant
CPT codes. We continue to believe that this approach is necessary to
maintain intra-family relativity of the PFS, and we maintain that CPT
code 51797 is an appropriate crosswalk to the

[[Page 59572]]

add-on CPT code 95984. We are finalizing a work RVU for CPT 95984 of
0.80.
Comment: One commenter stated that CMS reduced the nonfacility
service cost for clinical labor for CPT code 95970 to zero. The
commenter stated that this may be a potential oversight, given that the
RUC recommended nonfacility clinical labor time be reduced from 44 to
15 minutes. The commenter stated that it was not consistent for CMS to
recommend a nonfacility service cost of zero in light of the
nonfacility exam table (EF023) equipment time of 15 minutes, and that
this clinical labor should still be reflected in this service.
Response: We disagree with the commenter and note that the RUC did
not recommend any clinical labor time for CPT code 95970, as we
proposed the RUC-recommended direct PE inputs without refinement. We
believe that the equipment time assigned for the exam table (EF023) and
the neurostimulator programmer (EQ209) indicate that these equipment
items are in use by the practitioner and not the clinical staff.
After consideration of the public comments, we are finalizing the
work RVUs and direct PE inputs for the codes in the Neurostimulator
Services family of codes as proposed.
(56) Psychological and Neuropsychological Testing (CPT Codes 96105,
96110, 96116, 96125, 96127, 96112, 96113, 96121, 96130, 96131, 96132,
96133, 96136, 96137, 9613896138, 96139, 96X11, and 96146)
In CY 2016, the Psychological and Neuropsychological Testing family
of codes were identified as potentially misvalued using a high
expenditure services screen across specialties with Medicare allowed
charges of $10 million or more. The entire family of codes was referred
to the CPT Editorial Panel to be revised, as the testing practices had
been significantly altered by the growth and availability of
technology, leading to confusion about how to report the codes. In June
2017, the CPT Editorial Panel revised five existing codes, added 13
codes to provide better description of psychological and
neuropsychological testing, and deleted CPT codes 96101, 96102, 96103,
96111, 96118, 96119, and 96120. The RUC and HCPAC submitted
recommendations for the 13 new codes and for the existing CPT codes
96105, 96110, 96116, 96125, and 96127.
We proposed the RUC- and HCPAC-recommend work RVUs for several of
the CPT codes in this family: A work RVU of 1.75 for CPT code 96105; a
work RVU of 1.86 for CPT code 96116; a work RVU of 1.70 for CPT code
96125; a work RVU of 1.71 for CPT code 96121; a work RVU of 0.55 for
CPT code 96136; a work RVU of 0.46 for CPT code 96137; and a work RVU
of 0.51 for CPT code 96X11. CPT codes 96110, 96127, 96138, 96139, and
96146 were valued by the RUC for PE only.
This code family contains a subset of codes that describe
psychological and neuropsychological testing administration and
evaluation, not including assessment of aphasia, developmental
screening, or developmental testing. The CPT Editorial Panel's
recommended coding for this subset of services consists of seven new
codes: Two that describe either psychological or neuropsychological
testing when administered by physicians or other qualified health
professionals (CPT codes 96136 and 96137), and two for either type of
testing when administered by technicians (CPT codes 96138 and 96139);
and four new codes that describe testing evaluation by physicians or
other qualified health care professionals (CPT codes 96130 through
96133). This new coding effectively unbundles codes that currently
report the full course of testing into separate codes for testing
administration (CPT codes 96136, 96137, 96138, and 96139) and
evaluation (CPT codes 96130, 96131, and 96132). According to a
stakeholder that represents the psychologist and neuropsychologist
community, this new coding will result in significant reductions in
payment for these services due to the unbundling of the testing codes
into codes for physician-administered tests and technician-administered
tests. The stakeholder noted that because the new coding includes
testing codes with zero work RVUs for the technician administered tests
and the work RVUs are lower than they believe to be accurate, this new
valuation would ignore the clinical evaluation and decision making
performed by the physician or other qualified health professional
during the course of testing administration and evaluation.
Furthermore, the net result of the code valuations for these new codes
is a reduction in the overall work RVUs for this family of codes. In
other words, the stakeholder's analysis found that the RUC
recommendations result in a reduction in total work RVUs, even though
the actual physician work of a testing battery has not changed.
In the interest of payment stability for these high-volume
services, we proposed to implement work RVUs for this code family,
which would eliminate the approximately 2 percent reduction in work
spending. We proposed to achieve work neutrality for this code family
by scaling the work RVUs upward from the RUC-recommended values so that
the size of the pool of work RVUs would be essentially unchanged for
this family of services. Therefore, we proposed: A work RVU of 2.56 for
CPT code 96112, rather than the RUC-recommended work RVU of 2.50; a
work RVU of 1.16 for CPT code 96113, rather than the RUC-recommended
work RVU of 1.10; a work RVU of 2.56 for CPT code 96130, rather than
the RUC-recommended work RVU of 2.50; a work RVU of 1.96 for CPT code
96131, rather than the RUC-recommended work RVU of 1.90; a work RVU of
2.56 for CPT code 96132, rather than the RUC-recommended work RVU of
2.50; and a work RVU of 1.96 for CPT code 96133, rather than the RUC-
recommended work RVU of 1.90. We saw no evidence that the typical
practice for these services has changed to merit a reduction in
valuation of professional services.
The RUC made several revisions to the recommended direct PE inputs
for the administration codes from their respective predecessor codes,
including revisions to quantities of testing forms. For the supply
item, ``psych testing forms, average'' there is a quantity of 0.10 in
the predecessor CPT code 96101, and a quantity of 0.33 in the
predecessor CPT code 96102. For the supply item ``neurobehavioral
status forms, average,'' there is a quantity of 1.0 in the predecessor
CPT code 96118 and a quantity of 0.30 for predecessor CPT code 96119,
and for the supply item ``aphasia assessment forms, average,'' there is
a quantity of 1.0 in the predecessor CPT code 96118 and a quantity of
0.30 in predecessor CPT code 96119. The RUC recommendation does not
include any forms for CPT codes 96132 and 96133. The RUC has replaced
the corresponding predecessor supply items with new items ``WAIS-IV
Record Form,'' ``WAIS-IV Response Booklet #1,'' and ``WAIS-IV Response
Booklet #2,'' and assigned quantities of 0.165 for each of these new
supply items for CPT codes 96136 through 96139. In our analysis, we
found that the RUC-recommended direct PE refinements contributed
significantly to the reduction in the overall payment for this code
family. We saw no compelling evidence that the quantities of testing
forms used in a typical course of testing would have been reduced
dramatically and, in the interest of payment stability, we proposed to
refine the direct PE inputs for CPT codes 96132 through 96139 by
including 1.0 quantity each of the supply items ``WAIS-IV Record

[[Page 59573]]

Form,'' ``WAIS-IV Response Booklet #1'', and ``WAIS-IV Response Booklet
#2.'' We believe that a typical course of testing would involve use of
one booklet for each of the relevant codes. In addition, these proposed
refinements would largely mitigate potentially destabilizing payment
reductions for these services. We solicited comments on our proposed
work RVUs and proposed PE refinements for this family of services.
We also proposed to remove the equipment time for the CANTAB Mobile
(ED055) equipment item from CPT code 96146. This item was listed at
different points in the recommendations as a supply item with a cost of
$28 per assessment and as an equipment item for a software license with
a cost of $2,800 that could be used for up to 100 assessments. We were
unclear as to how the CANTAB Mobile would typically be used in this
procedure, and we proposed to remove the equipment time pending the
submission of more data about the item. We solicited additional
information about the use of this item and how it should best be
included into the PE methodology. We were also interested in
information as to whether the submitted invoice refers to the cost of
the mobile device itself, or the cost of user licenses for the mobile
device, which was unclear from the information submitted with the
recommendations.
The following is a summary of the comments we received regarding
our proposed work RVUs and proposed direct PE refinements for this
family of services.
Comment: Many commenters supported our proposal to increase payment
from the RUC recommendations in the interest of payment stability.
These commenters stated this proposal will help mitigate reductions in
reimbursement rates for psychologists.
According to some commenters, some psychologists will see slight
decreases for neuropsychological testing services due to the new coding
structure, which they say aligns psychological and neuropsychological
testing services with other testing services in the program. Some
commenters said that, due to the new coding structure, reimbursement
will be lower for neuropsychological evaluation services that are
provided by physicians than those provided by technicians. These
commenters stated that physicians should not be reimbursed at a lesser
rate than EEG or MRI technicians or other physician extenders.
Response: We note that our proposed values for the evaluation CPT
codes 96130 through 96133 and the administration and scoring CPT codes
96136 through 96139 are generally higher for the physician-administered
codes than for the analogous technician-administered codes. According
to our proposed rates, however, the valuation of the add-on code for
each additional 30 minutes of administration and scoring when performed
by a technician reported with CPT code 96139 is, however, slightly
higher than the valuation of the add-on code for each additional 30
minutes of administration and scoring when performed by a physician or
other qualified health care professional, reported with CPT code 96137.
We thank commenters for bringing this potential rank-order anomaly to
our attention. We believe that clinical staff will typically be
providing some support when the physician or other qualified health
care professional is performing testing administration as described by
CPT codes 96136 and 96137. We are therefore refining the direct PE
inputs for these services by adding 10 minutes of clinical labor time
for the CA021 clinical labor activity, ``Perform procedure/service--NOT
directly related to physician work time'' for these codes. We believe
this will more accurately reflect the clinical staff support that is
typical when a physician is performing test administration, and it will
preserve appropriate rank-order among this subset of services, while
mitigating reductions to payment rates for testing administration
services.
Comment: The RUC noted that in the February 5, 2018 RUC submission
to CMS, the RUC rescinded its interim recommendation from October 2017,
and stated that CPT code 96X11 is deleted and will not be a CPT code
for CPT 2019. The RUC recommended that CMS delete this service and work
RVU recommendation for the 2019 PFS.
Response: As CPT code 96X11 will not be a CPT code for CY 2019, we
are deleting this code. Based on the RUC-recommended utilization
crosswalk, our proposed rates included utilization assumptions that for
all services currently reported with CPT codes 96103 and 96120, half of
these services will be reported with the new CPT code 96X11 and half
will be reported with CPT code 96146. As we are not finalizing 96X11,
for the purposes of ratesetting, our utilization for these service will
include the assumption that half of the services currently reported
with 96103 and 96120 will be reported with CPT code 96136 and half with
CPT code 96146.
Comment: A commenter requested clarification on how much time is
considered typical for the neuropsychologist to perform record review
and test selection in newly created CPT codes 96132 and 96133.
Response: For CPT code 96132, we proposed the RUC-recommended 5
minutes of pre-service work time which reflects activities such as
preliminary selection of tests and record review. As CPT code 96133 is
an add-on code for reporting each additional hour, it does not include
additional pre-service work time, as the latter would be considered to
be included in the corresponding base code.
Comment: Several commenters disagreed with the proposal to remove
the equipment time for the CANTAB Mobile (ED055) equipment item from
CPT code 96146. Commenters stated that the PE Subcommittee determined
that this was a software license and it would be more appropriately
classified as equipment than as a supply. Commenters stated that they
had submitted paid invoices for two additional software license-based
automated instruments typically used when furnishing CPT code 96146,
and that they were resubmitting these same invoices with their comment
letter.
Response: We appreciate the feedback from the commenter that the
CANTAB Mobile (ED055) equipment item referred to a software license. We
continue to believe that software licenses would typically be
classified as a form of indirect PE under our methodology, and as a
result we are finalizing our proposal to remove this equipment time
from CPT code 96146.
Comment: A commenter requested clarification on why new CPT codes
96138, 96139, and 96146 do not include a facility fee, despite the fact
that their respective source CPT codes 96102, 96119, 96103, and 96120
do have RVUs in the facility setting.
Response: The source codes mentioned by the commenter have
associated work RVUs, while the new CPT codes do not, and they do not
include physician work time. The new CPT coding effectively unbundles
professional and technical services for some of these codes. Codes that
do not have a physician work component would typically not be valued in
the facility setting.
After consideration of the public comments, we are finalizing the
work RVUs for the codes in the Psychological and Neuropsychological
Testing family of codes as proposed. We are also finalizing the direct
PE inputs as proposed, with the exception of the refinement to the
CA021 clinical labor for CPT codes 96136 and 96137 as detailed above.

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(57) Electrocorticography (CPT Code 95836)
CPT Code 95829 is used for Electrocorticogram performed at the time
of surgery; however, a new code was needed to account for this non-
face-to-face service for the review of a month's worth or more of
stored data. CPT code 95836 (Electrocorticogram from an implanted brain
neurostimulator pulse generator/transmitter, including recording, with
interpretation and written report, up to 30 days) is a new code
approved at the September 2017 CPT Editorial Panel Meeting to describe
this service.
We disagreed with the RUC-recommended work RVU of 2.30 for CPT code
95836 and proposed a work RVU of 1.98 based on a direct crosswalk to
the top reference, CPT code 95957 (Digital analysis of
electroencephalogram (EEG) (e.g., for epileptic spike analysis)). This
is a recently-reviewed code with the same intraservice time of 30
minutes and a total time only 2 minutes lower than CPT code 95836. We
agreed with the survey respondents that CPT code 95957 was an accurate
valuation for this new code, and due to the clinically similar nature
of the two procedures and their near-identical time values, we proposed
to value both of them at the same work RVU of 1.98.
The RUC did not recommend, and we did not propose, any direct PE
inputs for CPT code 95836.
The following is a summary of the public comments we received on
our proposals involving CPT code 95836.
Comment: Many commenters disagreed with the proposed work RVU of
1.98 for CPT code 95836 and stated that CMS should finalize the RUC-
recommended work RVU of 2.30. Commenters stated that the survey
respondents chose CPT code 95957 as a reference service and not as a
direct crosswalk. Commenters stated that the survey respondents pick
from a list of 10-20 services to use as a comparison and then recommend
a work RVU based on the intensity, complexity and physician time
required to perform the surveyed code. Commenters stated that the
median survey work RVU was actually 2.97, much higher than the key
reference service, and that the respondents specifically indicated that
CPT code 95836 is more intense and complex than CPT code 95957 on all
measures.
Response: We disagree with the commenters that the key reference
service of CPT code 95957 would be an inappropriate choice for a direct
crosswalk, not least because the RUC commonly uses one of the key
reference services in exactly this fashion. While it is true that the
median survey work RVU was 2.97, we note that the RUC did not recommend
this work valuation either, instead choosing to recommend a work RVU of
2.30 in recognition that the survey median would be a value that is too
high to maintain relativity. Similarly, while the survey respondents
specifically indicated that CPT code 95836 is more intense and complex
than CPT code 95957 on all measures, we note that the survey
respondents also indicated that CPT code 95836 is more intense and
complex than the second key reference code, CPT code 95810
(Polysomnography; age 6 years or older, sleep staging with 4 or more
additional parameters of sleep, attended by a technologist) which has a
work RVU of 2.50. We proposed to use a crosswalk to CPT code 95957 not
only because it was selected by the survey participants as the top key
reference, but also because it is a recently-reviewed code with the
same intraservice time of 30 minutes and a total time only 2 minutes
lower than CPT code 95836. We continue to believe that this is the most
accurate choice for work valuation.
Comment: Several commenters stated that although the specialty
society did not submit any direct PE inputs, it is not a facility only
code. Commenters stated that CPT code 95836 can be performed in both
the nonfacility and the facility setting, and that the nonfacility is
actually the typical setting for this service. Commenters stated that
they understood that there would be no direct staffing, equipment or
supply costs associated with this service and that indirect costs would
be similar regardless of the setting in which the service is performed,
but there would still be indirect practice expense associated with
providing the service in the nonfacility. Commenters apologized for the
misunderstanding and requested that CPT code 95836 should be valued in
the nonfacility setting.
Response: We appreciate the additional information supplied by the
commenters on this issue. We will remove the ``NA'' designation from
the nonfacility setting for CPT code 95836. Due to the fact that there
are no direct PE inputs for CPT code 95836, the PE RVU will be the same
in both the nonfacility and facility settings because it is based
solely on the indirect PE methodology.
After consideration of the public comments, we are finalizing the
work RVU for CPT code 95836 as proposed. We are not finalizing any
direct PE inputs for this code, but we will value it in both the
facility and nonfacility settings as noted above.
(58) Chronic Care Remote Physiologic Monitoring (CPT Codes 99453,
99454, and 99457)
In the CY 2018 PFS final rule, we finalized separate payment for
CPT code 99091 (Collection and interpretation of physiologic data
(e.g., ECG, blood pressure, glucose monitoring) digitally stored and/or
transmitted by the patient and/or caregiver to the physician or other
qualified health care professional, qualified by education, training,
licensure/regulation (when applicable) requiring a minimum of 30
minutes of time) (82 FR 53014). In that rule, we indicated that there
would be new coding describing remote monitoring forthcoming from the
CPT Editorial Panel and the RUC (82 FR 53014). In September 2017, the
CPT Editorial Panel revised one code and created three new codes to
describe remote physiologic monitoring and management, and the RUC
provided valuation recommendations through our standard rulemaking
process.
CPT codes 99453 (Remote monitoring of physiologic parameter(s)
(e.g., weight, blood pressure, pulse oximetry, respiratory flow rate),
initial; set-up and patient education on use of equipment) and 99454
(Remote monitoring of physiologic parameter(s) (e.g., weight, blood
pressure, pulse oximetry, respiratory flow rate), initial; device(s)
supply with daily recording(s) or programmed alert(s) transmission,
each 30 days) are both PE-only codes. We proposed the RUC-recommended
work RVU of 0.61 for CPT code 99457 (Remote physiologic monitoring
treatment management services, 20 minutes or more of clinical staff/
physician/other qualified healthcare professional time in a calendar
month requiring interactive communication with the patient/caregiver
during the month).
For the direct PE inputs, we proposed to accept the RUC-recommended
direct PE inputs for CPT code 99453 and to remove the ``Monthly
cellular and licensing service fee'' supply from CPT code 99454. We do
not believe that these licensing fees will be allocated to the use of
an individual patient for an individual service, and instead believe
they can be better understood as forms of indirect costs similar to
office rent or administrative expenses. Therefore, we proposed to
remove this supply input as a form of indirect PE. We proposed the
direct PE inputs for CPT code 99457 without refinement.
The following is a summary of the public comments we received on
our

[[Page 59575]]

proposals involving the Chronic Care Remote Physiologic Monitoring
family of codes.
Comment: Commenters were very supportive of CMS making separate
payment for these services. Several commenters supported the proposal
of the RUC-recommended work RVU of 0.61 for CPT code 99457. A few
commenters stated that the proposed rates for these services were too
low, and that given industry standards, reimbursement should be
increased.
Response: We appreciate the support for our proposal from the
commenters.
Comment: Several commenters disagreed with the proposal to remove
the ``Monthly cellular and licensing service fee'' supply from CPT code
99454. Commenters stated that the monthly cellular and licensing
service fee was a direct practice expense input as it is allocable to
the patient for this service. Commenters stated that this fee is not a
license for the entire practice; rather it is an individually allocable
fee for the period that the patients is monitored and the physician
would not incur such fees if the patient did have the wireless monitor.
Commenters clarified that the fee is comprised of the monthly cost
associated with encryption of data for safe HIPAA compliant transfer,
programmed alerts, and the monthly cost of pre-loaded connectivity used
to transmit patient generated physiological data from a specific
patient to the provider's software. Commenters stated that reliance
upon a patient's cellular connectivity or WIFI, which may or may not be
operating based on patient technology capabilities, was not reliable
for medical delivery purposes.
Response: We disagree with the commenters and we continue to
believe that the monthly cellular and licensing service fee constitutes
a form of indirect PE. We believe that licensing and data costs are
administrative costs that are not unique to individual procedures, in
the same fashion that we do not assign separate direct PE for higher
electricity costs to diagnostic imaging procedures as compared to
cognitive evaluation procedures. We continue to believe that these data
costs are appropriately captured via the indirect PE methodology as
opposed to being included as a separate direct PE input. We also note
that other services that require around-the-clock monitoring, such as
the home PT/INR monitoring described in HCPCS code G0249 (Provision of
test materials and equipment for home inr monitoring of patient with
either mechanical heart valve(s), chronic atrial fibrillation, or
venous thromboembolism who meets Medicare coverage criteria; includes:
Provision of materials for use in the home and reporting of test
results to physician; testing not occurring more frequently than once a
week; testing materials, billing units of service include 4 tests), do
not include additional direct PE inputs for data costs, and we do not
believe it would be appropriate to include them for CPT code 99454.
Comment: One commenter stated that CMS should add the cost of
equipment sanitation and reprocessing as a one-time cost that is
directly attributable to a patient. The commenter stated that FDA
device guidelines require that a reusable medical device be
reprocessed, which includes sanitation or sterilization and ensuring
that all personal data is `wiped' or removed from the device. The
commenter stated that this cost was not considered by the RUC, however,
it is routinely part of the `set up' costs that are onetime costs
directly attributable to a patient.
Response: We disagree with the commenter that these expenses would
constitute a separate form of direct PE. We agree with the RUC, which
discussed the specialty society's recommended supply items, shipping
costs and a device reprocessing fee, and determined that these expenses
are not specifically allocable to the patient for this service, and
would be considered indirect practice expenses.
Comment: One commenter stated that there was direct time spent by
pharmacists for each patient, and the commenter requested that CMS
factor pharmacist time into the PE valuation for CPT codes 99453,
99454, 99091, and 99457.
Response: We typically do not consider time spent by a pharmacist
to be a part of the clinical labor time for purposes of direct PE. For
additional information, we direct readers to the Practice Expense
portion of this final rule (section II.B. of this final rule).
Comment: Many commenters pointed out that beneficiary cost sharing
is a significant barrier to the use of non-face-to-face services, like
remote patient monitoring. Commenters requested that CMS waive the cost
sharing requirements for these codes.
Response: We do not have the authority to make changes to the
applicable beneficiary cost sharing for most physicians' services,
including these.
Comment: Many commenters requested that CMS clarify the kinds of
technology covered under CPT codes 99453, 99454, and 99457. Commenters
provided examples of the kinds of technology these codes should cover
including software applications that could be integrated into a
beneficiary's smart phone, Holter-Monitors, Fit-Bits, or artificial
intelligence messaging. One commenter suggested that behavioral health
data and data from wellness applications be included as well. Another
commenter stated that the descriptor should include results of
patients' self-care tasks. Many commenters stated that CMS should
clarify certain elements in the scope of service and code descriptors
and issue appropriate sub-regulatory guidance. Commenters inquired as
to whether CPT code 99453 can be furnished via telecommunication
technology, if it can be billed again if the number of parameters
changed in the future. Commenters requested that CMS clarify the
meaning of ``programmed alerts transmission'' in the descriptor for CPT
code 99454, and whether it included transmissions that occurred other
than daily. Commenters also encouraged CMS to allow flexibility in the
time frame covered by these services.
Response: We plan to issue guidance to help inform practitioners
and stakeholders on these issues.
Comment: Commenters requested that CMS clarify whether CPT code
99457 can be billed incident to a practitioner's professional services
and asked that CMS make an exception to the direct supervision
requirements, stating that general supervision is sufficient for these
services.
Response: We note that CPT code 99457 describes professional time
and therefore cannot be furnished by auxiliary personnel incident to a
practitioner's professional services.
Comment: A few commenters suggested that additional medical
professionals, including pharmacists, paramedics, chiropractors,
physical therapists, occupational therapists and dentists should be
allowed to bill Medicare for these services. Other commenters requested
that CMS clarify the practitioners referred to as ``other qualified
healthcare professionals'' in the code descriptor.
Response: We note that all practitioners must practice in
accordance with applicable state law and scope of practice laws, and
that some of the practitioners identified by the commenters are not
authorized to bill Medicare independently for their services. We note
that the term, ``other qualified healthcare professionals,'' used in
the code descriptor is a defined by CPT, and that definition can be
found in the CPT Codebook.
Comment: A few commenters provided specific suggestions for
revising the code descriptors, including

[[Page 59576]]

the addition of secure messaging platforms, revision of the time
thresholds, specifying that the follow-up should be written in all
instances, including ``for medical consultative discussion and review''
in the descriptor for CPT codes 99446 through 99449, and striking
``referral services'' and rather, including language similar to the
other codes regarding ``assessment and management'' services. Other
commenters requested CMS clarify the definition of ``health record
assessment'' in the descriptors for CPT codes 99451 and 99452. One
commenter suggested that CMS add language about use of EHR to the
existing CPT codes, rather than finalize separate payment for CPT codes
99451 and 99452.
Response: While we appreciate all of the specific suggestions
regarding the code descriptions, we defer to the CPT to maintain code
descriptors for CPT codes. Where additional clarification is needed, we
may provide guidance in the future.
Comment: A few commenters urged CMS not to be prescriptive
regarding the technology that could be used to perform consultations,
including real-time video, a store-and-forward visit, or simply a
patient-provider message via a patient portal.
Response: While we are sympathetic to the commenters' desire not to
be overly prescriptive about the technology used to furnish these
services, especially given the speed at which technology evolves, we
note that we refer to the CPT code descriptors and guidance to
ascertain the scope of technology that is used to furnish these
services.
Comment: One commenter asked whether there were geographic
restrictions on these services.
Response: There are no geographic restrictions, as these services
are not Medicare telehealth services.
After considering the public comments, we are finalizing the RUC-
recommended work RVU of 0.61 for CPT code 99457 and the direct PE
inputs for all three codes as proposed.
(59) Interprofessional Internet Consultation (CPT Codes 99451, 99452,
99446, 99447, 99448, and 99449)
In September 2017, the CPT Editorial Panel revised four codes and
created two codes to describe interprofessional telephone/internet/
electronic medical record consultation services. CPT codes 99446
(Interprofessional telephone/internet assessment and management service
provided by a consultative physician including a verbal and written
report to the patient's treating/requesting physician or other
qualified health care professional; 5-10 minutes of medical
consultative discussion and review), 99447 (Interprofessional
telephone/internet assessment and management service provided by a
consultative physician including a verbal and written report to the
patient's treating/requesting physician or other qualified health care
professional; 11-20 minutes of medical consultative discussion and
review), 99448 (Interprofessional telephone/internet assessment and
management service provided by a consultative physician including a
verbal and written report to the patient's treating/requesting
physician or other qualified health care professional; 21-30 minutes of
medical consultative discussion and review), and 99449
(Interprofessional telephone/internet assessment and management service
provided by a consultative physician including a verbal and written
report to the patient's treating/requesting physician or other
qualified health care professional; 31 minutes or more of medical
consultative discussion and review) describe assessment and management
services in which a patient's treating physician or other qualified
healthcare professional requests the opinion and/or treatment advice of
a physician with specific specialty expertise to assist with the
diagnosis and/or management of the patient's problem without the need
for the face-to-face interaction between the patient and the
consultant. These CPT codes are currently assigned a procedure status
of B (bundled) and are not separately payable under Medicare. The CPT
Editorial Panel revised these codes to include electronic health record
consultations, and the RUC reaffirmed the work RVUs it had previously
submitted for these codes. We reevaluated the submitted recommendations
and, in light of changes in medical practice and technology, we
proposed to change the procedure status for CPT codes 99446, 99447,
99448, and 99449 from B (bundled) to A (active). We also proposed the
RUC re-affirmed work RVUs of 0.35 for CPT code 99446, 0.70 for CPT code
99447, 1.05 for CPT code 99448, and 1.40 for CPT code 99449.
The CPT Editorial Panel also created two new codes, CPT code 99452
(Interprofessional telephone/internet/electronic health record referral
service(s) provided by a treating/requesting physician or qualified
health care professional, 30 minutes) and CPT code 99451
(Interprofessional telephone/internet/electronic health record
assessment and management service provided by a consultative physician
including a written report to the patient's treating/requesting
physician or other qualified health care professional, 5 or more
minutes of medical consultative time). The RUC-recommended work RVUs
are 0.50 for CPT code 99452 and 0.70 for 99451. Since the CPT code for
the treating/requesting physician or qualified healthcare professional
and the CPT code for the consultative physician have similar
intraservice times, we believe that these CPT codes should have equal
values for work. Therefore, we proposed a work RVU of 0.50 for both CPT
codes 99452 and 99451.
We welcomed comments on this proposal. We also direct readers to
section II.D. of this final rule, Modernizing Medicare Physician
Payment by Recognizing Communication Technology-Based Services, which
includes additional detail regarding our policies for modernizing
Medicare physician payment by recognizing communication technology-
based services.
There are no recommended direct PE inputs for the codes in this
family.
The following is a summary of the public comments we received on
our proposals involving the Interprofessional Internet Consultation
family of codes.
Comment: Almost all commenters were supportive of CMS' proposal to
unbundle CPT codes 99446 through 99449 and make separate payment for
CPT codes 99452 and 99451. Almost all commenters did not support
lowering the RVU of CPT code 99451 to 0.50 as the work of the
consulting physician in CPT code 99451 is more intense than the work of
the treating physician in CPT code 99452. Commenters stated that the
consulting practitioner exercises greater effort, both in judgment and
technical skill to make a recommendation for the treatment of a
previously unknown patient than the treating physician does in
conveying the relevant information. A few commenters expressed concern
that the proposed work RVU for CPT code 99452 is too low, and does not
accurately reflect the resources associated with the work of the
treating physician.
Response: We agree with commenters that the work of the consulting
physician is significant, and we are persuaded by the additional
descriptions of that work provided by commenters. We also agree with
the commenters who suggested that the proposed work RVU of 0.50 for CPT
code 99452 undervalues the work associated with aggregating patient
information, communicating with the consulting practitioner, and

[[Page 59577]]

implementing the results of the consultation. We continue, however, to
have concerns regarding the valuation of these services. We note that
there are instances where the patient would not be new to the
consulting practitioner, and therefore the intensity of the work would
be reduced. We are also concerned that, given the similarity of
intraservice times, CPT code 99452 is undervalued relative to CPT code
99451, especially since the code descriptor for CPT code 99452
specifies that the consulting practitioner can spend a minimum of 5
minutes providing the consultation. We believe that a work RVU of 0.50
more accurately describes the work associated with both services. Given
the similarity of intraservice times and the information indicating
that both codes may be undervalued at 0.50 RVUs, we are finalizing a
work RVU of 0.70 for CPT codes 99451 and 99452.
Comment: A few commenters expressed concern that these codes were
only payable in the facility setting.
Response: These codes are payable in both facility and non-facility
settings.
Comment: One commenter requested that CMS include pharmacists as
clinical staff in the direct PE.
Response: We direct readers to the discussion of this issue in the
PE section of the rule (Section II.B. of this final rule). We also note
that these codes do not have direct PE inputs.
(60) Chronic Care Management Services (CPT Code 99491)
In February 2017, the CPT Editorial Panel created a new code to
describe at least 30 minutes of chronic care management services
performed personally by the physician or qualified health care
professional over one calendar month. CMS began making separate payment
for CPT code 99490 (Chronic care management services, at least 20
minutes of clinical staff time directed by a physician or other
qualified health care professional, per calendar month, with the
following required elements: Multiple (two or more) chronic conditions
expected to last at least 12 months, or until the death of the patient;
chronic conditions place the patient at significant risk of death,
acute exacerbation/decompensation, or functional decline; comprehensive
care plan established, implemented, revised, or monitored) in CY 2015
(79 FR 67715). CPT code 99490 describes 20 minutes of clinical staff
time spent on care management services for patients with 2 or more
chronic conditions. CPT code 99490 also includes 15 minutes of
physician time for supervision of clinical staff. For CY 2019, the CPT
Editorial Panel created CPT code 99491 (Chronic care management
services, provided personally by a physician or other qualified health
care professional, at least 30 minutes of physician or other qualified
health care professional time, per calendar month, with the following
required elements: Multiple (two or more) chronic conditions expected
to last at least 12 months, or until the death of the patient, chronic
conditions place the patient at significant risk of death, acute
exacerbation/decompensation, or functional decline; comprehensive care
plan established, implemented, revised, or monitored) to describe
situations when the billing practitioner is doing the care coordination
work that is attributed to clinical staff in CPT code 99490. For CPT
code 99491, the RUC recommended a work RVU of 1.45 for 30 minutes of
physician time.
We believe this work RVU overvalues the resource costs associated
with the physician performing the same care coordination activities
that are performed by clinical staff in the service described by CPT
code 99490. Additionally, this valuation of the work is higher than
that of CPT code 99487 (Complex chronic care management services, with
the following required elements: Multiple (two or more) chronic
conditions expected to last at least 12 months, or until the death of
the patient, chronic conditions place the patient at significant risk
of death, acute exacerbation/decompensation, or functional decline,
establishment or substantial revision of a comprehensive care plan,
moderate or high complexity medical decision making; 60 minutes of
clinical staff time directed by a physician or other qualified health
care professional, per calendar month), which includes 60 minutes of
clinical staff time, creating a rank order anomaly within the family of
codes if we were to accept the RUC-recommended value.
CPT code 99490 has a work RVU of 0.61 for 15 minutes of physician
time. Therefore, as CPT code 99491 describes 30 minutes of physician
time, we proposed a work RVU of 1.22, which is double the work RVU of
CPT code 99490.
We did not propose any direct PE refinements for this code family.
The following is a summary of the public comments we received on
our proposals involving CPT code 99491.
Comment: Almost all commenters recommended that CMS finalize the
RUC-recommended work value of 1.45 for 99491. The RUC stated that CPT
code 99491 is different from the existing chronic care management (CCM)
services codes because those codes are performed by clinical staff
under the supervision of a physician, while CPT code 99491 is performed
by the physicians themselves. Commenters also stated that the typical
patient requiring that the physician personally perform the care
management services is of greater acuity than the typical patient for
whom CCM may be performed by clinical staff. Additionally, CPT code
99491 cannot be reported with CPT code 99490 or CPT code 99487, and
must therefore account for all of the care management work in the
month. Commenters also pointed out that there are multiple examples of
CMS valuing the work of a physician more highly than clinical staff
when they perform the same services, for example CPT codes 96101
(Psychological testing (includes psychodiagnostic assessment of
emotionality, intellectual abilities, personality and psychopathology,
e.g., MMPI, Rorschach, WAIS), per hour of the psychologist's or
physician's time, both face-to-face time administering tests to the
patient and time interpreting these test results and preparing the
report) and 96102 (Psychological testing (includes psychodiagnostic
assessment of emotionality, intellectual abilities, personality and
psychopathology, e.g., MMPI and WAIS), with qualified health care
professional interpretation and report, administered by technician, per
hour of technician time, face-to-face.)
Response: We agree with commenters that a work RVU of 1.45
accurately captures the resources associated when a physician furnishes
CCM. We agree that in most cases, the physician would perform CCM on
patients with higher acuity and therefore the care planning and medical
decision making would be of greater intensity. We also agree with
commenters that the work associated with personally performing CCM as
opposed to supervising clinical staff is also of greater intensity.
Therefore, we are finalizing that value based on our review of comments
received.
Comment: A few commenters requested that CMS clarify that CPT code
99491 can be performed incident to a practitioner's professional
services.
Response: CPT code 99491 is specifically for use when the billing
practitioner personally performs care management services, so this code
cannot be furnished incident to a practitioner's professional services.
(61) Diabetes Management Training (HCPCS Codes G0108 and G0109)
HCPCS codes G0108 (Diabetes outpatient self-management training
services, individual, per 30 minutes) and G0109 (Diabetes outpatient
self-

[[Page 59578]]

management training services, group session (2 or more), per 30
minutes) were identified on a screen of CMS or Other source codes with
Medicare utilization greater than 100,000 services annually. For CY
2019, we proposed the HCPAC-recommended work RVU of 0.90 for HCPCS code
G0108 and the HCPAC-recommended work RVU of 0.25 for HCPCS code G0109.
For the direct PE inputs, we noted that there was a significant
disparity between the specialty recommendation and the final
recommendation submitted by the HCPAC. We were concerned about the
significant decreases in direct PE inputs in the final recommendation
when compared to the current makeup of the two codes. The final HCPAC
recommendation removed a series of different syringes and the patient
education booklet that currently accompanies the procedure. We believe
that injection training is part of these services and that the supplies
associated with that training would typically be included in the
procedures. Due to these concerns, we proposed to maintain the current
direct PE inputs for HCPCS codes G0108 and G0109. Therefore, we
proposed not to add the new supply item ``20x30 inch self-stick easel
pad, white, 30 sheets/pad'' (SK129) to HCPCS code G0109 that was
included in the final HCPAC recommendation, as it was not a current
supply for HCPCS code G0109; however, we proposed to accept the
submitted invoice price and to add the supply to our direct PE
database.
The following is a summary of the public comments we received on
our proposals involving the Diabetes Management Training family of
codes.
Comment: Several commenters supported the proposal of the HCPAC-
recommended work RVUs. Commenters also stated that they applauded CMS
for recognizing and addressing the significant disparity in direct PE
inputs between the specialty recommendations and the final
recommendations submitted to CMS by the HCPAC.
Response: We appreciate the support for our proposals from the
commenters.
Comment: One commenter expressed disappointment that CMS did not
address barriers in Medicare that impact beneficiary utilization of the
diabetes self-management training (DSMT) benefit. The commenter stated
that CMS solicited comments from stakeholders in the CY 2017 PFS
proposed rule on this subject, and the commenter has been part of
ongoing conversations with CMS about this issue, through in-person
meetings and written communications, over the past two years. The
commenter stated that they were hopeful CMS would use this opportunity
to address barriers to DSMT given that utilization of the DSMT benefit
stands at only 5 percent of eligible Medicare beneficiaries.
Response: We appreciate the feedback from the commenter, and we
will consider these issues for future rulemaking. However, we note that
we did not specifically make any proposals associated with these
subjects in the CY 2019 proposed rule.
Comment: One commenter stated that the final HCPAC recommendations
removed a series of different syringes and the patient education
booklet that currently accompany these procedures. The commenter stated
that several anti-glycemic medications other than insulin require
injection with a syringe and a significant number of persons with both
type 1 and type 2 diabetes are prescribed these medications, however
the list of supplies in the current direct PE inputs does not include
syringes. The commenter therefore recommended that CMS add a series of
different syringes to the direct PE inputs for HCPCS codes G0108 and
G0109.
Response: We proposed to maintain the current direct PE inputs for
HCPCS codes G0108 and G0109, which do not currently include the syringe
supplies described by the commenter (supply codes SC051, SC052, and
SC055). Although we are sensitive to the concerns raised by the
commenter, we do not believe that adding these syringe supplies to the
procedures would be consistent with our policy of maintaining the
current direct PE inputs.
After consideration of the public comments, we are finalizing the
work RVUs and the direct PE inputs for the codes in the Diabetes
Management Training family of codes as proposed.
(62) External Counterpulsation (HCPCS Code G0166)
HCPCS code G0166 (External counterpulsation, per treatment session)
was identified on a screen of CMS or Other source codes with Medicare
utilization greater than 100,000 services annually. The RUC is not
recommending a work RVU for HCPCS code G0166 because they found that
there is no physician work involved in this service. After reviewing
this code, we proposed a work RVU of 0.00 for HCPCS code G0166, and
proposed to make the code valued for PE only. For the direct PE inputs,
we proposed to refine the equipment times in accordance with our
standard equipment time formulas.
The following is a summary of the public comments we received on
our proposals involving HCPCS code G0166.
Comment: A commenter agreed with the proposal that an individual
treatment session would have no physician work and supported the
proposed direct PE inputs. However, the commenter stated that future
coding solutions may be necessary to recognize management of these
services that is additional to that captured by E/M coding.
Response: We appreciate the feedback from the commenter, and we
will consider this information for future rulemaking.
After consideration of the public comments, we are finalizing the
work RVU and direct PE inputs for HCPCS code G0166 as proposed.
(63) Wound Closure by Adhesive (HCPCS Code G0168)
HCPCS code G0168 (Wound closure utilizing tissue adhesive(s) only)
was identified as potentially misvalued on a screen of 0-day global
services reported with an E/M visit 50 percent of the time or more, on
the same day of service by the same patient and the same practitioner,
that have not been reviewed in the last 5 years with Medicare
utilization greater than 20,000. For CY 2019, the RUC recommended a
work RVU of 0.45 based on maintaining the current work RVU.
We disagreed with the recommended value and we proposed a work RVU
of 0.31 for HCPCS code G0168 based on a direct crosswalk to CPT code
93293 (Transtelephonic rhythm strip pacemaker evaluation(s) single,
dual, or multiple lead pacemaker system, includes recording with and
without magnet application with analysis, review and report(s) by a
physician or other qualified health care professional, up to 90 days).
CPT code 93293 is a recently-reviewed code with the same 5 minutes of
intraservice time and 1 fewer minute of total time. In reviewing HCPCS
code G0168, the recommendations stated that the work involved in the
service had not changed even though the surveyed intraservice time was
decreasing by 50 percent, from 10 minutes to 5 minutes. Although we did
not imply that the decrease in time as reflected in survey values must
equate to a one-to-one or linear decrease in the valuation of work
RVUs, we believe that since the two components of work are time and
intensity, significant decreases in time should be reflected in
decreases to work RVUs. In the case of HCPCS code G0168, we believe
that it would be more accurate to propose a work RVU of 0.31 based on

[[Page 59579]]

the aforementioned crosswalk to CPT code 93293 to account for these
decreases in the surveyed work time. Maintaining the current work RVU
of 0.45 despite a 50 percent decrease in the surveyed intraservice time
would result in a significant increase in the intensity of HCPCS code
G0168, and we have no reason to believe that the procedure has
increased in intensity since the last time that it was valued.
For the direct PE inputs, we proposed to refine the equipment times
in accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on
our proposals involving HCPCS code G0168.
Comment: Many commenters disagreed with the proposed work RVU of
0.31 for HCPCS code G0168 and stated that CMS should finalize the
HCPAC-recommended work RVU of 0.45. Commenters stated that CMS should
not compare the valid survey time to the current work time because the
initial CMS/Other source data is flawed and maintains zero validity for
comparison. Commenters stated that surveyed time was never obtained
from physicians who perform this service and should not be used as a
comparison.
Response: We agree that it is important to use the most recent data
available regarding time, and we note that when many years have passed
between when time is measured, significant discrepancies can occur.
However, we also believe that our operating assumption regarding the
validity of the existing values as a point of comparison is critical to
the integrity of the relative value system as currently constructed.
The times currently associated with codes play a very important element
in PFS ratesetting, both as points of comparison in establishing work
RVUs and in the allocation of indirect PE RVUs by specialty. If we were
to operate under the assumption that previously recommended work times
had routinely been overestimated, this would undermine the relativity
of the work RVUs on the PFS in general, given the process under which
codes are often valued by comparisons to codes with similar times and
it undermine the validity of the allocation of indirect PE RVUs to
physician specialties across the PFS. Instead, we believe that it is
crucial that the code valuation process take place with the
understanding that the existing work times, used in the PFS ratesetting
processes, are accurate. We recognize that adjusting work RVUs for
changes in time is not always a straightforward process and that the
intensity associated with changes in time is not necessarily always
linear, which is why we apply various methodologies to identify several
potential work values for individual codes. However, we want to
reiterate that we believe it would be irresponsible to ignore changes
in time based on the best data available and that we are statutorily
obligated to consider both time and intensity in establishing work RVUs
for PFS services. For additional information regarding the use of old
work time values in our methodology, we refer readers to our discussion
of the subject in the CY 2017 final rule (81 FR 80273 through 80274).
Comment: Several commenters stated that HCPCS code G0168 should not
be crosswalked to CPT code 93293, as this is an evaluation of pacemaker
strips over a 90 day period. Commenters stated that the skill of
closing a facial laceration, typically near the eye, using a surgical
tissue adhesive for HCPCS code G0168 is more intense and complex to
perform than CPT code 93293 and thus should be valued higher.
Commenters stated that CPT code 51702 (Insertion of temporary
indwelling bladder catheter; simple (e.g., Foley)) would be a better
reference service.
Response: We disagree with the commenters that CPT code 93293 would
be an inappropriate choice for a crosswalk. CPT code 93293 describes a
transtelephonic rhythm strip pacemaker evaluation(s) for a single,
dual, or multiple lead pacemaker system. We do not agree that this
crosswalk code has lower intensity or complexity due to the cognitive
work involved in evaluating the patient correctly. Both CPT code 93293
and HCPCS code G0168 require skill on the part of the practitioner,
only of different types. We also believe that our crosswalk to CPT code
92393 is a more accurate choice because it has the same intraservice
work time (5 minutes) closely matches the total work time (13 minutes
as opposed to 14 minutes) of HCPCS code G0168. By contrast, CPT code
51702 has nearly double the total work time at 25 minutes, which
accounts for its higher work RVU of 0.50.
After consideration of the public comments, we are finalizing the
work RVU and direct PE inputs for HCPCS code G0168 as proposed.
(64) Removal of Impacted Cerumen (HCPCS Code G0268)
HCPCS code G0268 (Removal of impacted cerumen (one or both ears) by
physician on same date of service as audiologic function testing) was
identified as potentially misvalued on a screen of 0-day global
services reported with an E/M visit 50 percent of the time or more, on
the same day of service by the same patient and the same practitioner,
that have not been reviewed in the last 5 years with Medicare
utilization greater than 20,000. For CY 2019, we proposed the RUC-
recommended work RVU of 0.61 for HCPCS code G0268.
For the direct PE inputs, we proposed to remove the clinical labor
time for the ``Clean surgical instrument package'' (CA026) activity.
There is no surgical instrument pack included in the recommended
equipment for HCPCS code G0268, and this code already includes the
standard 3 minutes allocated for cleaning the room and equipment. In
addition, all of the instruments used in the procedure appear to be
disposable supplies that would not require cleaning since they would
only be used a single time.
The following is a summary of the public comments we received on
our proposals involving HCPCS code G0268.
Comment: Several commenters supported our proposal of the HCPAC-
recommended work RVU as well as the refinement to the direct PE inputs.
Response: We appreciate the support for our proposals from the
commenters.
After consideration of the public comments, we are finalizing the
work RVU and direct PE inputs for HCPCS code G0268 as proposed.
(65) Structured Assessment, Brief Intervention, and Referral to
Treatment for Substance Use Disorders (HCPCS Codes G0396, G0397, and
G2011)
In response to the Request for Information in the CY 2018 PFS
proposed rule (82 FR 34172), commenters requested that CMS pay
separately for assessment and referral related to substance use
disorders. In the CY 2008 PFS final rule (72 FR 66371), we created two
G-codes to allow for appropriate Medicare reporting and payment for
alcohol and substance abuse assessment and intervention services that
are not provided as screening services, but that are performed in the
context of the diagnosis or treatment of illness or injury. The codes
are HCPCS code G0396 (Alcohol and/or substance (other than tobacco)
abuse structured assessment (e.g., AUDIT, DAST) and brief intervention,
15 to 30 minutes)) and HCPCS code G0397 (Alcohol and/or substance
(other than tobacco) abuse structured assessment (e.g., AUDIT, DAST)
and intervention greater than 30 minutes)). In 2008, we instructed
Medicare contractors to pay for these codes only when the services were
considered reasonable and necessary.

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Given the ongoing opioid epidemic and the current needs of the
Medicare population, we expect that these services would often be
reasonable and necessary. However, the utilization for these services
is relatively low, which we believe is in part due to the service-
specific documentation requirements for these codes (the current
requirements are available at https://www.cms.gov/Outreach-and-
Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/
SBIRT_Factsheet_ICN904084.pdf). We believe that removing the additional
documentation requirements will also ease the administrative burden on
providers. Therefore, for CY 2019, we proposed to eliminate the
service-specific documentation requirements for HCPCS codes G0397 and
G0398. We welcomed comments on our proposal to change the documentation
requirements for these codes.
The following is a summary of the comments we received regarding
our proposal to change the documentation requirements for these codes.
Comment: The majority of commenters were supportive of this
proposal, some noting that this will ease administrative burden and
some noting that this will incentivize providers to deliver SBIRT
services, thereby increasing access to this service. One commenter
stated they believe that practitioners are not utilizing SBIRT for
illicit drug use due to the absence of conclusive evidence to support
use of this service for illicit drug use and therefore, support
removing the service documentation requirements for SBIRT when used to
screen for unhealthy alcohol use, but not when used to screen for
illicit drug use.
Response: We thank the commenters for their feedback. We note that
the services described by HCPCS codes G0397 and G0398 describe services
for alcohol and/or substance abuse; we believe it would be
administratively burdensome for practitioners were we to create varying
rules for different diagnoses. Additionally, it is our intention to
increase access to care for services that may be of use in addressing
all substance use disorders, especially in light of the ongoing opioid
epidemic. Therefore, we are finalizing our proposal to eliminate the
service-specific documentation requirements for HCPCS codes G0397 and
G0398.
Additionally, we proposed to create a third HCPCS code G2011with a
lower time threshold in order to accurately account for the resource
costs when practitioners furnish these services, but do not meet the
minimum time requirements of the existing codes. We note that in the
proposed rule we referred to this service as HCPCS code GSBR1, which
was a placeholder code. The code will be described as G2011: Alcohol
and/or substance (other than tobacco) abuse structured assessment
(e.g., AUDIT, DAST), and brief intervention, 5-14 minutes. We proposed
a work RVU of 0.33, based on the intraservice time ratio between HCPCS
codes G0396 and G0397. We welcomed comments on this code descriptor and
proposed valuation for HCPCS code G2011.
The following is a summary of the comments we received on this code
descriptor and proposed valuation for HCPCS code G2011.
Comment: Commenters were supportive of creating this code and the
valuation proposed, and noted the lower time threshold will allow
physicians the opportunity to provide brief counseling rather than 15
or more minutes of discussion, which requires extended interest from a
patient who may not yet be ready for prolonged discussion and/or is
receptive to being referred to another health care provider for
treatment. One commenter recommended finalizing guidance that allows
the newly proposed SBIRT HCPCS code to be used for alcohol, but not
illicit drug use.
Response: We thank the commenters for their feedback. After
considering these comments, we are finalizing the code descriptor and
valuation for HCPCS code G2011 as proposed. We believe the code
descriptor and guidance for this new SBIRT HCPCS code should be
consistent with the existing SBIRT HCPCS codes. For future rulemaking
we would consider recommendations on how to refine this family of codes
under our standard process of reviewing codes.
(66) Prolonged Services (HCPCS Code GPRO1)
CPT codes 99354 (Prolonged evaluation and management or
psychotherapy service(s) (beyond the typical service time of the
primary procedure) in the office or other outpatient setting requiring
direct patient contact beyond the usual service; first hour (List
separately in addition to code for office or other outpatient
Evaluation and Management or psychotherapy service)) and 99355
(Prolonged evaluation and management or psychotherapy service(s)
(beyond the typical service time of the primary procedure) in the
office or other outpatient setting requiring direct patient contact
beyond the usual service; each additional 30 minutes (List separately
in addition to code for prolonged service)) describe additional time
spent face-to-face with a patient. Stakeholders have shared with us
that the threshold of 60 minutes for CPT code 99354 is difficult to
meet and is an impediment to billing these codes. In response to
stakeholder feedback and as part of our proposal as discussed in
section II.I. of this final rule, Evaluation and Management Services,
to implement a single PFS rate for E/M visit levels 2-5 while
maintaining payment stability across the specialties, we proposed HCPCS
code GPRO1 (Prolonged evaluation and management or psychotherapy
service(s) (beyond the typical service time of the primary procedure)
in the office or other outpatient setting requiring direct patient
contact beyond the usual service; 30 minutes (List separately in
addition to code for office or other outpatient Evaluation and
Management or psychotherapy service)), which could be billed with any
level of E/M code. We noted that we did not propose to make any changes
to CPT codes 99354 and 99355, which can still be billed, as needed,
when their time thresholds and all other requirements are met. We
proposed a work RVU of 1.17, which is equal to half of the work RVU
assigned to CPT code 99354. Additionally, we proposed direct PE inputs
for HCPCS code GPRO1 that are equal to one half of the values assigned
to CPT code 99354, which can be found in the Direct PE Inputs public
use file for this final rule.
Comment: As almost all commenters did not support the overall E/M
coding and payment proposals, we did not receive many comments with
specific suggestions on valuation for HCPCS code GPRO1. Of the
commenters that supported creation of the code, most supported the
proposed valuation while others, while supporting the creation of a 30-
minute prolonged services code in principle, encouraged CMS to wait for
recommendations from the CPT Editorial Panel and the RUC.
Response: For CY 2021, we are finalizing the proposed add-on code
for HCPCS code GPRO1 using the input values, as proposed. We note that
prior to implementation for 2021, we could consider, through
rulemaking, the code and its valuation in the context of any potential
changes to CPT codes and/or recommendations offered by stakeholders,
including the RUC, as part of our annual process for valuing PFS
services. See section II.I. of this final rule for further discussion
of the E/M policy.

[[Page 59581]]

(67) Remote Pre-Recorded Services (HCPCS Code G2010)
For CY 2019, we proposed to make separate payment for remote
evaluation services when a physician uses pre-recorded video and/or
images submitted by a patient in order to evaluate a patient's
condition through new HCPCS G-code G2010 (Remote evaluation of recorded
video and/or images submitted by the patient (e.g., store and forward),
including interpretation with verbal follow-up with the patient within
24 business hours, not originating from a related E/M service provided
within the previous 7 days nor leading to an E/M service or procedure
within the next 24 hours or soonest available appointment). We proposed
to value this service by a direct crosswalk to CPT code 93793
(Anticoagulant management for a patient taking warfarin, must include
review and interpretation of a new home, office, or lab international
normalized ratio (INR) test result, patient instructions, dosage
adjustment (as needed), and scheduling of additional test(s), when
performed), as we believe the work described is similar in kind and
intensity to the work performed as part of HCPCS code G2010. Therefore,
we proposed a work RVU of 0.18, preservice time of 3 minutes,
intraservice time of 4 minutes, and post service time of 2 minutes. We
also proposed to add 6 minutes of clinical labor (L037D) in the service
period. We solicited comment on the code descriptor and valuation for
HCPCS code G2010. We direct readers to section II.D. of this final
rule, which includes additional detail regarding our proposed policies
for modernizing Medicare physician payment by recognizing communication
technology-based services.
The following is a summary of the comments we received on the code
descriptor and valuation for HCPCS code G2010.
Comment: Several commenters stated that the proposed payment rate
is too low, citing that it is below market compared to the rate many
asynchronous telemedicine companies pay their contracted/employed
physician staff, and noted that new patients in particular require more
resources, whereas others stated that the proposed valuation was
appropriate.
Response: We believe that the proposed valuation accurately
reflects the resources involved in furnishing this service and note
that we are finalizing limiting this service to established patients.
We also note that we plan to monitor the utilization of this code and
routinely address recommended changes in values for codes paid under
the PFS.
After considering the public comments, we are finalizing the work
RVU and direct PE inputs for HCPCS code G2010 as proposed.
(68) Brief Communication Technology-Based Service, e.g. Virtual Check-
In (HCPCS Code G2012)
We proposed to create a G-code, HCPCS code G2012 (Brief
communication technology based service, e.g. virtual check-in, by a
physician or other qualified health care professional who may report
evaluation and management services provided to an established patient,
not originating from a related E/M service provided within the previous
7 days nor leading to an E/M service or procedure within the next 24
hours or soonest available appointment; 5-10 minutes of medical
discussion) to facilitate payment for these brief communication
technology-based services. We proposed to base the code descriptor and
valuation for HCPCS code G2012 on existing CPT code 99441 (Telephone
evaluation and management service by a physician or other qualified
health care professional who may report evaluation and management
services provided to an established patient, parent, or guardian not
originating from a related E/M service provided within the previous 7
days nor leading to an E/M service or procedure within the next 24
hours or soonest available appointment; 5-10 minutes of medical
discussion), which is currently not separately payable under the PFS.
As CPT code 99441 only describes telephone calls, we are proposing to
create a new HCPCS code G2012 to encompass a broader array of
communication modalities. We do, however, believe that the resource
assumptions for CPT code 99441 would accurately account for the costs
associated with providing the proposed virtual check-in service,
regardless of the technology. We proposed a work RVU of 0.25, based on
a direct crosswalk to CPT code 99441. For the direct PE inputs for
HCPCS code G2012, we also proposed the direct PE inputs assigned to CPT
code 99441. Given the breadth of technologies that could be described
as telecommunications, we anticipated receiving public comments and
working with the CPT Editorial Panel and the RUC to evaluate whether
separate coding and payment is needed to account for differentiation
between communication modalities. We solicited comment on the code
descriptor, as well as the proposed valuation for HCPCS code G2012. We
direct readers to section II.D. of this final rule, which includes
additional detail regarding our proposed policies for modernizing
Medicare physician payment by recognizing communication technology-
based services.
The following is a summary of the comments we received on the code
descriptor, as well as the proposed valuation for HCPCS code G2012.
Comment: Several commenters stated that the proposed payment rate
would be inadequate for modalities that are both audio and visual
capable, whereas other commenters stated that the proposed valuation
was appropriate.
Response: We appreciate the input provided by the commenters. As
noted in section II.D. of this final rule, we are finalizing the
valuation for this service as proposed. We note that we are finalizing
allowing audio-only real-time telephone interactions in addition to
synchronous, two-way audio interactions that are enhanced with video or
other kinds of data transmission. We believe the proposed valuation
reflects the low work time and intensity and accounts for the resource
costs and efficiencies associated with the use of communication
technology. We recognize that the valuation of this service is
relatively modest, especially compared to in-person services, however,
we believe that the proposed valuation accurately reflects the
resources involved in furnishing this service.
We plan to monitor the utilization of this code and note that we
routinely address recommended changes in values for codes paid under
the PFS and would expect to do this in future rulemaking.
After consideration of the public comments, we are finalizing the
work RVU and direct PE inputs for HCPCS code G2012 as proposed.
(69) Visit Complexity Inherent to Certain Specialist Visits (HCPCS Code
GCG0X)
We proposed to create a HCPCS G-code to be reported with an E/M
service to describe the additional resource costs for specialties for
whom E/M visit codes make up a large percentage of their total allowed
charges and who we believe primarily bill level 4 and level 5 visits.
The treatment approaches for these specialties generally do not have
separate coding and are generally reported using the E/M visit codes.
We proposed to create HCPCS code, GCG0X (Visit complexity inherent to
evaluation and management associated with endocrinology, rheumatology,
hematology/oncology, urology, neurology, obstetrics/gynecology,
allergy/immunology, otolaryngology, or

[[Page 59582]]

interventional pain management-centered care (Add-on code, list
separately in addition to an evaluation and management visit)). We
proposed a valuation for HCPCS code GCG0X based on a crosswalk to 75
percent of the work RVU and time of CPT code 90785 (Interactive
complexity), which would result in a proposed work RVU of 0.25 and a
physician time of 8.25 minutes for HCPCS code GCG0X. CPT code 90785 has
no direct PE inputs. Interactive complexity is an add-on code that may
be billed when a psychotherapy or psychiatric service requires more
work due to the complexity of the patient. We believe that this work
RVU and physician time would be an accurate representation of the
additional work associated with the higher level complex visits. For
further discussion of proposals relating to this code, see section
II.I. of this final rule. We solicited comment on the code descriptor,
as well as the proposed valuation for HCPCS code GCG0X.
The following is a summary of the comments we received on the code
descriptor, as well as the proposed valuation for HCPCS code GCG0X.
Comment: As almost all commenters did not support the overall E/M
coding and payment proposals, we did not receive comments with specific
suggestions on valuation for HCPCS code GCG0X.
Response: For CY 2021, we are finalizing the proposed add-on code
for visit complexity inherent to non-procedural specialty care using
the input values, as proposed. We note that prior to implementation for
CY 2021, we could consider, through rulemaking, the code and its
valuation in the context of any potential changes to CPT codes and/or
recommendations offered by stakeholders, including the RUC, as part of
our annual process for valuing PFS services. See section II.I. of this
final rule for further discussion of the E/M policy.
(70) Visit Complexity Inherent to Primary Care Services (HCPCS Code
GPC1X)
We proposed to create a HCPCS G-code for primary care services,
GPC1X (Visit complexity inherent to evaluation and management
associated with primary medical care services that serve as the
continuing focal point for all needed health care services (Add-on
code, list separately in addition to an evaluation and management
visit)). This code describes furnishing a visit to a new or existing
patient, and can include aspects of care management, counseling, or
treatment of acute or chronic conditions not accounted for by other
coding. HCPCS code GPC1X would be billed in addition to the E/M visit
code when the visit involved primary care-focused services. We proposed
a work RVU of 0.07, physician time of 1.75 minutes. This proposed
valuation accounts for the additional work resource costs associated
with furnishing primary care that distinguishes E/M primary care visits
from other types of E/M visits and maintains work budget neutrality
across the office/outpatient E/M code set. For further discussion of
proposals relating to this code, see section II.I. of this final rule.
We solicited comment on the code descriptor, as well as the proposed
valuation for HCPCS code GPC1X.
The following is a summary of the comments we received on the code
descriptor, as well as the proposed valuation for HCPCS code GPC1X.
Comment: We received a few comments suggesting that the primary
care add-on was undervalued, particularly in comparison to the add-on
code for specialty visit complexity. A few commenters suggested that,
at the very least, we should equalize the value for these codes.
Response: We agree that the proposed inputs do not reflect the
resources associated with furnishing primary care visits. For CY 2021,
we are finalizing the proposed add-on code for visit complexity
inherent to primary care using the inputs associated with HCPCS code
GCG1X: A work RVU of 0.25 and a physician time of 8.25 minutes. We note
that prior to implementation for 2021, we could consider, through
rulemaking, the code and its valuation in the context of any potential
changes to CPT codes and/or recommendations offered by stakeholders,
including the RUC, as part of our annual process for valuing PFS
services. See section II.I. of this final rule for further discussion
of the E/M policy.
(71) Podiatric Evaluation and Management Services (HCPCS Codes GPD0X
and GPD1X)
We proposed to create two HCPCS G-codes, HCPCS codes GPD0X
(Podiatry services, medical examination and evaluation with initiation
of diagnostic and treatment program, new patient) and GPD1X (Podiatry
services, medical examination and evaluation with initiation of
diagnostic and treatment program, established patient), to describe
podiatric evaluation and management services. We proposed a work RVU of
1.36, a physician time of 28.19 minutes, and direct costs summing to
$21.29 for HCPCS code GPD0X, and a work RVU of 0.85, physician time of
21.73 minutes, and direct costs summing to $15.87 for HCPCS code GPD1X.
These values are based on the average rate for CPT codes 99201-99203
and CPT codes 99211-99212 respectively, weighted by podiatric volume.
For further discussion of proposals relating to these codes, see
section II.I. of this final rule.
Comment: As almost all commenters did not support the overall E/M
coding and payment proposals and these codes specifically, we did not
receive comments with specific suggestions on valuation.
Response: In response to comments, we are not finalizing HCPCS
codes GPD0X and GPD1X for CY 2019. See section X of this final rule for
further discussion of the E/M policy.
(72) Comment Solicitation on Superficial Radiation Treatment Planning
and Management
In the CY 2015 PFS final rule with comment period (79 FR 67666
through 67667), we noted that changes to the CPT prefatory language
limited the codes that could be reported when describing services
associated with superficial radiation treatment (SRT) delivery,
described by CPT code 77401 (radiation treatment delivery, superficial
and/or ortho voltage, per day). The changes effectively meant that many
other related services were bundled with CPT code 77401, instead of
being separately reported. For example, CPT guidance clarified that
certain codes used to describe clinical treatment planning, treatment
devices, isodose planning, physics consultation, and radiation
treatment management cannot be reported when furnished in association
with SRT. Stakeholders informed us that these changes to the CPT
prefatory language prevented them from billing Medicare for codes that
were previously frequently billed with CPT code 77401. We solicited
comments as to whether the revised bundled coding for SRT allowed for
accurate reporting of the associated services. In the CY 2016 PFS final
rule with comment period (80 FR 70955), we noted that the RUC did not
review the inputs for SRT procedures, and therefore, did not assess
whether changes in valuation were appropriate in light of the bundling
of associated services. In addition, we solicited recommendations from
stakeholders regarding whether it would be appropriate to add physician
work for this service, even though physician work is not included in
other radiation treatment services. In the CY 2018 PFS proposed rule
(82 FR 34012) and the CY 2018 PFS final rule (82 FR 53082), we noted
that the 2016 National Correct

[[Page 59583]]

Coding Initiative (NCCI) Policy Manual for Medicare Services states
that radiation oncology services may not be separately reported with E/
M codes. While this NCCI edit is no longer active stakeholders have
stated that MACs have denied claims for E/M services associated with
SRT based on the NCCI policy manual language. According to
stakeholders, the bundling of SRT with associated services, as well as
coding confusion regarding the appropriate use of E/M coding to report
associated physician work, meant that practitioners were not being paid
appropriately for planning and treatment management associated with
furnishing SRT. Due to these concerns regarding reporting of services
associated with SRT, in the CY 2018 PFS proposed rule (82 FR 34012
through 34013), we proposed to make separate payment for the
professional planning and management associated with SRT using HCPCS
code GRRR1 (Superficial radiation treatment planning and management
related services, including but not limited to, when performed,
clinical treatment planning (for example, 77261, 77262, 77263),
therapeutic radiology simulation-aided field setting (for example,
77280, 77285, 77290, 77293), basic radiation dosimetry calculation (for
example, 77300), treatment devices (for example, 77332, 77333, 77334),
isodose planning (for example, 77306, 77307, 77316, 77317, 77318),
radiation treatment management (for example, 77427, 77431, 77432,
77435, 77469, 77470, 77499), and associated E/M per course of
treatment). We proposed that this code would describe the range of
professional services associated with a course of SRT, including
services similar to those not otherwise separately reportable under CPT
guidance. Furthermore, we proposed that this code would have included
several inputs associated with related professional services such as
treatment planning, treatment devices, and treatment management. Many
commenters did not support our proposal to make separate payment for
HCPCS code GRRR1 for CY 2018, stating that our proposed valuation of
HCPCS code GRRR1 would represent a significant payment reduction for
the associated services as compared with the list of services that they
could previously bill in association with SRT. Commenters voiced
concern that the proposed coding would inhibit access to care and
discourage the use of SRT as a non-surgical alternative to Mohs
surgery. We received comments recommending a variety of potential
coding solutions but without a consistent preferred alternative. In the
CY 2018 PFS final rule (82 FR 53081-53083), we solicited further
comment, and stated that we would continue our dialogue with
stakeholders to address appropriate coding and payment for professional
services associated with SRT.
Given stakeholder feedback that we have continued to receive
following the publication of the CY 2018 PFS final rule, we continue to
believe that there are potential coding gaps for SRT-related
professional services. We generally rely on the CPT process to
determine coding specificity, and we believe that deferring to this
process in addressing potential coding gaps is generally preferable. As
our previous attempt at designing a coding solution in the CY 2018 PFS
proposed rule did not gain stakeholder consensus, and given that there
were various, in some cases diverging, suggestions on a coding solution
from stakeholders, we did not propose changes relating to SRT coding,
SRT-related professional codes, or payment policies for CY 2019.
However, we solicited comment on the possibility of creating multiple
G-codes specific to services associated with SRT, as was suggested by
one stakeholder following the CY 2018 PFS final rule. These codes would
be used separately to report services including SRT planning, initial
patient simulation visit, treatment device design and construction
associated with SRT, SRT management, and medical physics consultation.
We solicited comment on whether we should create such G-codes to
separately report each of the services described previously, mirroring
the coding of other types of radiation treatment delivery. For
instance, HCPCS code G6003 (Radiation treatment delivery, single
treatment area, single port or parallel opposed ports, simple blocks or
no blocks: Up to 5 mev) is used to report radiation treatment delivery,
while associated professional services are billed with codes such as
CPT codes 77427 (Radiation treatment management, 5 treatments), 77261
(Therapeutic radiology treatment planning; simple), 77332 (Treatment
devices, design and construction; simple (simple block, simple bolus),
and 77300 (Basic radiation dosimetry calculation, central axis depth
dose calculation, TDF, NSD, gap calculation, off axis factor, tissue
inhomogeneity factors, calculation of non-ionizing radiation surface
and depth dose, as required during course of treatment, only when
prescribed by the treating physician).
We stated that we consider contractor pricing such codes for CY
2019 because we believe that the preferable method to develop new
coding is with multi-specialty input through the CPT and RUC process,
and we prefer to defer nationally pricing such codes pending input from
the CPT Editorial Panel and the RUC process to assist in determining
the appropriate level of coding specificity for SRT-related
professional services. Based on stakeholder feedback, we continue to
believe there may be a coding gap for these services, and therefore, we
solicited comment on whether we should create these G-codes and allow
them to be contractor priced for CY 2019. This would be an interim
approach for addressing the potential coding gap until the CPT
Editorial Panel and the RUC can address coding for SRT and SRT-related
professional services, giving the CPT Editorial Panel and the RUC an
opportunity to develop a coding solution that could be addressed in
future rulemaking.
The following is a summary of the comments we received on the
possibility of creating multiple G-codes specific to services
associated with SRT, which could be used separately to report services
including SRT planning, initial patient simulation visit, treatment
device design and construction associated with SRT, SRT management, and
medical physics consultation, which would be contractor priced for CY
2019.
Comment: Many commenters urged CMS to make appropriate payment for
SRT-related services, stating that it is a vital non-surgical
alternative treatment for skin cancer. Many commenters also said that
coding should recognize newer generation, Image Guided Superficial
Radiation (IGSRT), stating that IGSRT is the most advanced form of this
technology, and has far better outcomes compared to those achieved with
SRT.
Some commenters recommended implementation of G-codes for SRT-
related professional services, and they submitted alternative G-code
scenarios that they believe would be preferable to adopting contractor-
priced G-codes. These scenarios include one in which there would be one
code for SRT-related treatment planning, with a value based on a
crosswalk to CPT code 77261 (Therapeutic radiology treatment planning;
simple), a code for SRT treatment device construction, with a value
based on a crosswalk to CPT code 77332 (Treatment devices, design and
construction; simple (simple block, simple bolus), and a code for SRT
treatment management billed once per treatment, valued with a crosswalk
to CPT code 99213 (Office or other outpatient visit for the evaluation
and management of an established patient,

[[Page 59584]]

which requires at least 2 of these 3 key components: An expanded
problem focused history; An expanded problem focused examination;
Medical decision making of low complexity. Counseling and coordination
of care with other physicians, other qualified health care
professionals, or agencies are provided consistent with the nature of
the problem(s) and the patient's and/or family's needs. Usually, the
presenting problem(s) are of low to moderate severity. Typically, 15
minutes are spent face-to-face with the patient and/or family.).
According to this commenter, image guidance and tracking should not be
billed with superficial treatments. Another commenter suggested a
single code bundling SRT-related treatment management with SRT-related
device construction as well as a code for SRT-related radiation
treatment management, and a code representing treatment for multiple
lesions. This commenter also urged us to either revalue CPT code 77401
or to create an additional G-code billable with CPT code 77401 to
represent professional services associated with SRT. Another commenter
suggested a code for SRT-related radiology treatment planning, and an
SRT management code including five treatments. A commenter suggested a
coding structure that recognizes Image-Guided Superficial Radiation
Therapy as a newer generation of SRT, and would consist of CPT code
77401 for practitioners that utilize the SRT technologies; relying on
human visualization for lesion(s) simulation, treatment and tracking,
and a new G-code for providers who provide the newer generation
technology relying on image-guided lesion simulation, treatment and
tracking per fraction with Record and Verify precision tracking of
treatment progress.
A commenter stated that any codes utilized as part of superficial
radiation treatment delivery that include medical physics time should
require that a qualified medical physicist perform the physics work.
A commenter stated that adopting contractor-priced G codes would be
appropriate. Some other commenters, however, did not support our
suggested adoption of contractor-priced codes. According to these
commenters, we are correct in our belief that there are coding gaps in
the current reimbursement structure, however a fuller evaluation that
does not defer to Medicare contractors in determining reimbursement
rates is appropriate. According to a commenter, contractor pricing
creates unnecessary work for the Medicare Administrative Contractors
and can also lead to wide variances in the valuing of codes across
jurisdictions. Commenters expressed preference that coding for these
services be developed through the CPT and RUC processes. Many
commenters urged us not to change coding for CY 2019 for these
services.
Response: We expect to take these comments into consideration for
future rulemaking and we hope to continue a dialogue with stakeholders
on these important services. We reiterate that we believe multi-
specialty input through the CPT and RUC processes is the ideal way to
develop coding specificity and evaluation, and we are not making any
changes to payment policy based on this comment solicitation. In the
interim, we refer readers to CPT guidance that states that CPT code
77401, when performed, may be reported with appropriate E/M codes, and
this is the appropriate way to currently report professional work
associated with SRT. Going forward, we will attempt to determine
whether MACs are inappropriately denying billing of E/M codes with CPT
code 77401, and we will instruct MACs accordingly.
(73) Adaptive Behavior Analysis Services
We note that we intended to assign a contractor price status in the
Addendum B file of the proposed rule for the following CPT codes that
describe adaptive behavior analysis services: CPT codes 97151, 97152,
97153, 97154, 97155, 97156, 97157, and 97158. These codes are formerly
contractor priced Category III CPT codes that were converted to
Category I for CY 2019. We inadvertently excluded these codes in the
Addendum B file of the proposed rule, and have updated the Addendum B
file for this final rule.
BILLING CODE 4120-01-P

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Table 15--CY 2019 Invoices Received for Existing Direct PE Inputs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimated
non-
facility
Current Updated Percent Number of allowed
CPT/HCPCS codes Item name CMS code price price change invoices services
for HCPCS
codes using
this item
--------------------------------------------------------------------------------------------------------------------------------------------------------
53850..................................... kit, transurethral SA036 1,149.00 1,000.00 -13 1 5,608
microwave thermotherapy.
53852..................................... kit, transurethral needle SA037 1,050.00 900.00 -14 2 2,476
ablation (TUNA).
85097..................................... stain, Wright's Pack (per SL140 0.05 0.16 235 1 43,183
slide).
96116, 96118, 96119, 96125................ neurobehavioral status SK050 5.77 4.00 -31 3 414,139
forms, average.
258 codes................................. scope video system ES031 33,391.00 36,306.00 9 ......... 2,480,515
(monitor, processor,
digital capture, cart,
printer, LED light).
--------------------------------------------------------------------------------------------------------------------------------------------------------

Table 16--CY 2019 New Invoices
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of NF Allowed
CPT/HCPCS codes Item name CMS code Average price invoices services
--------------------------------------------------------------------------------------------------------------------------------------------------------
10011, 10012............................. MREYE Chiba Biopsy Needle... SC106 37.00 1 0
33285.................................... subcutaneous cardiac rhythm SA127 5,032.50 4 280
monitor system.
36572, 36573, 36584...................... Turbo-Ject PICC Line........ SD331 170.00 1 24,402
53854.................................... kit, Rezum delivery device.. SA128 1,150.00 1 121
53854.................................... generator, water EQ389 27,538.00 10 121
thermotherapy procedure.
58100.................................... Uterine Sound............... SD329 3.17 1 59,152
58100.................................... Tenaculum................... SD330 3.77 1 59,152
76391.................................... MR Elastography Package..... EL050 200,684.50 1 350
76978, 76979............................. bubble contrast............. SD332 126.59 1 89
76978, 76979............................. Ultrasound Contrast Imaging ER108 5,760.00 1 89
Package.
76981, 76982, 76983...................... sheer wave elastography ED060 9,600.00 1 493
software.
77048, 77049............................. CAD Software................ ED058 43,308.12 1 36,675
77046, 77047, 77048, 77049............... Breast coil................. EQ388 83,200.00 1 39,785
77048, 77049............................. CAD Workstation (CPU + Color ED056 12,031.52 1 36,675
Monitor).
85097.................................... slide stainer, automated, EP121 8,649.43 1 34,559
hematology.
92273.................................... Sleep mask.................. SK133 9.95 1 10,266
92273, 92274............................. mfERG and ffERG EQ390 102,400.00 1 25,602
electrodiagnostic unit.
92273, 92274............................. Contact lens electrode for EQ391 1,440.00 1 25,602
mfERG and ffERG.
96136, 96137, 96138, 96139............... WAIS-IV Record Form......... SK130 5.25 1 301,452
96136, 96137, 96138, 96139............... WAIS-IV Response Booklet #1. SK131 3.30 1 301,452
96136, 96137, 96138, 96139............... WMS-IV Response Booklet #2.. SK132 2.00 1 301,452
96136, 96137, 96138, 96139............... Wechsler Adult Intelligence EQ387 971.30 1 301,452
Scale--Fourth Edition (WAIS-
IV) Kit (less forms).
99454.................................... heart failure patient EQ392 1,000.00 1 58
physiologic monitoring
equipment package.
G0109.................................... 20x30 inch self-stick easel SK129 0.00 0 93,576
pad, white, 30 sheets/pad.
none..................................... needle holder, Mayo Hegar, SC105 3.03 1 0
6''.
--------------------------------------------------------------------------------------------------------------------------------------------------------

Table 17--CY 2019 No PE Refinements
------------------------------------------------------------------------
HCPCS Description
------------------------------------------------------------------------
10004............................. Fna bx w/o img gdn ea addl.
10006............................. Fna bx w/us gdn ea addl.
10008............................. Fna bx w/fluor gdn ea addl.
10010............................. Fna bx w/ct gdn ea addl.
10011............................. Fna bx w/mr gdn 1st les.
10012............................. Fna bx w/mr gdn ea addl.
11103............................. Tangntl bx skin ea sep/addl.
11105............................. Punch bx skin ea sep/addl.
11107............................. Incal bx skn ea sep/addl.
33274............................. Tcat insj/rpl perm ldls pm.
33275............................. Tcat rmvl perm ldls pm.
33285............................. Insj subq car rhythm mntr.
33286............................. Rmvl subq car rhythm mntr.
33289............................. Tcat impl wrls p-art prs snr.
36568............................. Insj picc <5 yr w/o imaging.
36569............................. Insj picc 5 yr+ w/o imaging.
36572............................. Insj picc rs&i <5 yr.
36573............................. Insj picc rs&i 5 yr+.
36584............................. Compl rplcmt picc rs&i.
38531............................. Open bx/exc inguinofem nodes.
49422............................. Remove tunneled ip cath.
50436............................. Dilat xst trc ndurlgc px.
50437............................. Dilat xst trc new access rcs.
53850............................. Prostatic microwave thermotx.
53852............................. Prostatic rf thermotx.
53854............................. Trurl dstrj prst8 tiss rf wv.
57150............................. Treat vagina infection.
57160............................. Insert pessary/other device.
58110............................. Bx done w/colposcopy add-on.
65205............................. Remove foreign body from eye.
65210............................. Remove foreign body from eye.
67500............................. Inject/treat eye socket
67505............................. Inject/treat eye socket.
67515............................. Inject/treat eye socket.
74485............................. Dilation urtr/urt rs&i.
76514............................. Echo exam of eye thickness.

[[Page 59625]]

76942............................. Echo guide for biopsy.
76981............................. Use parenchyma.
76982............................. Use 1st target lesion.
76983............................. Use ea addl. target lesion.
77081............................. Dxa bone density/peripheral.
93264............................. Rem mntr wrls p-art prs snr.
93668............................. Peripheral vascular rehab.
95800............................. Slp stdy unattended.
95801............................. Slp stdy unatnd w/anal.
95806............................. Sleep study unatt&resp efft.
95836............................. Ecog impltd brn npgt <30 d.
95970............................. Alys npgt w/o prgrmg.
95976............................. Alys smpl cn npgt prgrmg.
95977............................. Alys cplx cn npgt prgrmg.
95983............................. Alys brn npgt prgrmg 15 min.
95984............................. Alys brn npgt prgrmg addl 15.
96105............................. Assessment of aphasia.
96110............................. Developmental screen w/score.
96112............................. Devel tst phys/qhp 1st hr.
96113............................. Devel tst phys/qhp ea addl.
96116............................. Neurobehavioral status exam.
96121............................. Nubhvl xm phy/qhp ea addl hr.
96125............................. Cognitive test by hc pro.
96127............................. Brief emotional/behav assmt.
96130............................. Psycl tst eval phys/qhp 1st.
96131............................. Psycl tst eval phys/qhp ea.
99453............................. Rem mntr physiol param setup.
99457............................. Rem physiol mntr 20 min mo.
99491............................. Chrnc care mgmt svc 30 min.
G0166............................. Extrnl counterpulse, per tx.
------------------------------------------------------------------------

I. Evaluation & Management (E/M) Visits

1. Background
a. E/M Visits Coding Structure
Physicians and other practitioners paid under the PFS bill for
common office visits for evaluation and management (E/M) services under
a relatively generic set of CPT codes (Level I HCPCS codes) that
distinguish visits based on the level of complexity, site of service,
and whether the patient is new or established. The CPT codes have three
key components:
History of Present Illness (History),
Physical Examination (Exam) and
Medical Decision Making (MDM).
These codes are broadly referred to as E/M visit codes. There are
three to five E/M visit code levels, depending on site of service and
the extent of the three components of history, exam and MDM. For
example, there are three to four levels of E/M visit codes in the
inpatient hospital and nursing facility settings, based on a relatively
narrow degree of complexity in those settings. In contrast, there are
five levels of E/M visit codes in the office or other outpatient
setting based on a broader range of complexity in those settings.
Current PFS payment rates for E/M visit codes increase with the
level of visit billed. As for all services under the PFS, the rates are
based on the resources in terms of work (time and intensity), PE and
malpractice expense required to furnish the typical case of the
service. The current payment rates reflect typical service times for
each code that are based on RUC recommendations.
In total, E/M visits comprise approximately 40 percent of allowed
charges for PFS services, and office/outpatient E/M visits comprise
approximately 20 percent of allowed charges for PFS services. Within
these percentages, there is significant variation among specialties.
According to Medicare claims data, E/M visits are furnished by nearly
all specialties, but represent a greater share of total allowed
services for physicians and other practitioners who do not routinely
furnish procedural interventions or diagnostic tests. Generally, these
practitioners include both primary care practitioners and specialists
such as neurologists, endocrinologists and rheumatologists. Certain
specialties, such as podiatry, tend to furnish lower level E/M visits
more often than higher level E/M visits. Some specialties, such as
dermatology and otolaryngology, tend to bill more E/M visits on the
same day as they bill minor procedures.
Potential misvaluation of E/M codes is an issue that we have been
carefully considering for several years. We have discussed at length in
our recent PFS proposed and final rules that the E/M visit code set is
outdated and needs to be revised and revalued (for example: 81 FR 46200
and 76 FR 42793). We have noted that this code set represents a high
proportion of PFS expenditures, but has not been recently revalued to
account for significant changes in the disease burden of the Medicare
patient population and changes in health care practice that are
underway to meet the Medicare population's health care needs (81 FR
46200). In the CY 2012 PFS proposed rule, we proposed to refer all E/M
codes to the RUC for review as potentially misvalued (76 FR 42793).
Many commenters to that rule were concerned about the possible
inadequacies of the current E/M coding and documentation structure to
address evolving chronic care management and to support primary care
(76 FR 73060 through 73064). We did not finalize our proposal to refer
the E/M codes for RUC review at that time. Instead, we stated that we
would allow time for consideration of the findings of certain
demonstrations and other initiatives to provide improved information
for the valuation of chronic care management, primary care, and care
transitions. We stated that we would also continue to consider the
numerous policy alternatives that commenters offered, such as separate
E/M codes for established visits for patients with chronic disease
versus a post-surgical follow-up office visit.
Many stakeholders continue to similarly express to us through
letters, meetings, public comments in past rulemaking cycles, and other
avenues, that the E/M code set is outdated and needs to be revised. For
example, some stakeholders recommend an extensive research effort to
revise and revalue E/M services, especially physician work inputs (CY
2017 PFS final rule, 81 FR 80227-80228). In recent years, we have
continued to consider the best ways to recognize the significant
changes in health care practice, especially innovations in the active
management and ongoing care of chronically ill patients, under the PFS.
We have been engaged in an ongoing, incremental effort to identify gaps
in appropriate coding and payment.
b. E/M Documentation Guidelines
For coding and billing E/M visits to Medicare, practitioners may
use one of two versions of the E/M Documentation Guidelines for a
patient encounter, commonly referenced based on the year of their
release: the ``1995'' or ``1997'' E/M Documentation Guidelines. These
guidelines are available on the CMS website.\3\ They specify the
medical record information within each of the three key components
(such as number of body systems reviewed) that serves as support for
billing a given level of E/M visit. The 1995 and 1997 guidelines are
very similar to the guidelines that reside within the AMA's CPT
codebook for E/M visits. For example, the core structure of what
comprises or defines the different levels of history, exam, and medical
decision-making are the same. However, the 1995 and 1997 guidelines
include extensive examples of clinical work that comprise different
levels of medical decision-making and do not appear in the AMA's CPT
codebook. Also, the 1995 and 1997 guidelines do not contain references
to preventive care that appear in the AMA's CPT codebook. We provide an
example of how the 1995 and 1997 guidelines distinguish between level 2
and level 3 E/M visits in Table 18.
---------------------------------------------------------------------------

\3\ See https://www.cms.gov/Outreach-and-Education/Medicare-
Learning-Network-MLN/MLNEdWebGuide/Downloads/95Docguidelines.pdf;
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-
Network-MLN/MLNEdWebGuide/Downloads/97Docguidelines.pdf; and the
Evaluation and Management Services guide at https://www.cms.gov/
Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/
Downloads/eval-mgmt-serv-guide-ICN006764.pdf.
---------------------------------------------------------------------------

BILLING CODE 4120-01-P

[[Page 59626]]

[GRAPHIC] [TIFF OMITTED] TR23NO18.287

BILLING CODE 4120-01-C
According to both Medicare claims processing manual instructions
and CPT coding rules, when counseling and/or coordination of care
accounts for more than 50 percent of the face-to-face physician/patient
encounter (or, in the case of inpatient E/M services, the floor time)
the duration of the visit can be used as an alternative basis to select
the appropriate E/M visit level (Pub. L. 100-04, Medicare Claims
Processing Manual, Chapter 12, Section 30.6.1.C available at https://
www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/
clm104c12.pdf; see also 2017 CPT Codebook Evaluation and Management
Services Guidelines, page 10). Public Law 100-04, Medicare Claims
Processing Manual, Chapter 12, Section 30.6.1.B states, ``Instruct
physicians to select the code for the service based upon the content of
the service. The duration of the visit is an ancillary factor and does
not control the level of the service to be billed unless more than 50
percent of the face-to-face time (for non-inpatient services) or more
than 50 percent of the floor time (for inpatient services) is spent
providing counseling or coordination of care as described in subsection
C.'' Subsection C states that ``the physician may document time spent
with the patient in conjunction with the medical decision-making
involved and a description of the coordination of care or counseling
provided. Documentation must be in sufficient detail to support the
claim.'' The example included in subsection C further states, ``The
code selection is based on the total time of the face-to-face encounter
or floor time, not just the counseling time. The medical record must be
documented in sufficient detail

[[Page 59627]]

to justify the selection of the specific code if time is the basis for
selection of the code.''
Both the 1995 and 1997 E/M guidelines contain guidelines that
address time, which state that ``In the case where counseling and/or
coordination of care dominates (more than 50 percent of) the physician/
patient and/or family encounter (face-to-face time in the office or
other outpatient setting or floor/unit time in the hospital or nursing
facility), time is considered the key or controlling factor to qualify
for a particular level of E/M services.'' The guidelines go on to state
that ``If the physician elects to report the level of service based on
counseling and/or coordination of care, the total length of time of the
encounter (face-to-face or floor time, as appropriate) should be
documented and the record should describe the counseling and/or
activities to coordinate care.'' \4\
---------------------------------------------------------------------------

\4\ Page 16 of the 1995 E/M guidelines and page 48 of the 1997
guidelines.
---------------------------------------------------------------------------

We note that other manual provisions regarding E/M visits that are
cited in this final rule are housed separately within Medicare's
Internet-Only Manuals, and are not contained within the 1995 or 1997 E/
M documentation guidelines.
In accordance with section 1862(a)(1)(A) of the Act, which requires
services paid under Medicare Part B to be reasonable and necessary for
the diagnosis or treatment of illness or injury or to improve the
functioning of a malformed body member, medical necessity is a
prerequisite to Medicare payment for E/M visits. The Medicare Claims
Processing Manual states, ``Medical necessity of a service is the
overarching criterion for payment in addition to the individual
requirements of a CPT code. It would not be medically necessary or
appropriate to bill a higher level of evaluation and management service
when a lower level of service is warranted. The volume of documentation
should not be the primary influence upon which a specific level of
service is billed. Documentation should support the level of service
reported'' (Pub. L. 100-04, Medicare Claims Processing Manual, Chapter
12, Section 30.6.1.A., available on the CMS website at https://
www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/
clm104c12.pdf).
Stakeholders have long maintained that all of the E/M documentation
guidelines are administratively burdensome and outdated with respect to
the practice of medicine. Stakeholders have provided CMS with examples
of such outdated material (on history, exam and MDM) that can be found
within all versions of the E/M guidelines (the AMA's CPT codebook, the
1995 guidelines and the 1997 guidelines). Stakeholders have told CMS
that they believe the guidelines are too complex, ambiguous, fail to
meaningfully distinguish differences among code levels, and are not
updated for changes in technology, especially electronic health record
(EHR) use. Prior attempts to revise the E/M guidelines were
unsuccessful or resulted in additional complexity due to lack of
stakeholder consensus (with widely varying views among specialties),
and differing perspectives on whether code revaluation would be
necessary under the PFS as a result of revising the guidelines, which
contributed another layer of complexity to the considerations. For
example, an early attempt to revise the guidelines resulted in an
additional version designed for use by certain specialties (the 1997
version), and in CMS allowing the use of either the 1995 or 1997
versions for purposes of documentation and billing to Medicare. Another
complication in revising the guidelines is that they are also used by
many other payers, which have their own payment rules and audit
protocols. Moreover, stakeholders have suggested that there is
sometimes variation in how Medicare's own contractors (Medicare
Administrative Contractors (MACs)) interpret and apply the guidelines
as part of their audit processes.
As previously mentioned, in recent years, some clinicians and other
stakeholders have requested a major CMS research initiative to overhaul
not only the E/M documentation guidelines, but also the underlying
coding structure and valuation. Stakeholders have reported to CMS that
they believe the E/M visit codes themselves need substantial updating
and revaluation to reflect changes in the practice of medicine, and
that revising the documentation guidelines without addressing the codes
themselves simply preserves an antiquated framework for payment of E/M
services.
Last year, CMS sought public comment on potential changes to the E/
M documentation rules, deferring making any changes to E/M coding
itself in order to immediately focus on revision of the E/M guidelines
to reduce unnecessary administrative burden (82 FR 34078 through
34080). In the CY 2018 PFS final rule (82 FR 53163 through 53166), we
summarized the public comments we received and stated that we would
take that feedback into consideration for future rulemaking. In
response to commenters' request that we provide additional venues for
stakeholder input, we held a listening session this year on March 18,
2018 (transcript and materials are available on the CMS website at
https://www.cms.gov/Outreach-and-Education/Outreach/NPC/National-
Provider-Calls-and-Events-Items/2018-03-21-Documentation-Guidelines-
and-Burden-
Reduction.html?DLPage=1&DLEntries=10&DLSort=0&DLSortDir=descending). We
also sought input by participating in several listening sessions
recently hosted by the Office of the National Coordinator for Health
Information Technology (ONC) in the course of implementing section
4001(a) of the 21st Century Cures Act (Pub. L. 114-255). This provision
requires the Department of Health and Human Services to establish a
goal, develop a strategy, and make recommendations to reduce regulatory
or administrative burdens relating to the use of EHRs. The ONC
listening sessions sought public input on the E/M guidelines as one
part of broader, related and unrelated burdens associated with EHRs.
Several themes emerged from this recent stakeholder input.
Stakeholders commended CMS for undertaking efforts to revise the E/M
guidelines and recommended a multi-year process. Many commenters
advised CMS to obtain further input across specialties. They
recommended town halls, open door forums or a task force that would
come up with replacement guidelines that would work for all specialties
over the course of several years. They urged CMS to proceed cautiously
given the magnitude of the undertaking; past failed reform attempts by
the AMA, CMS, and other payers; and the wide-ranging impact of any
changes (for example, how other payers approach the issue).
We received substantially different recommendations by specialty.
Based on this feedback, it is clear that any changes would have
meaningful specialty-specific impacts, both clinical and financial.
Based on this feedback, it also seems that the history and exam
portions of the guidelines are most significantly outdated with respect
to current clinical practice.
A few stakeholders seemed to indicate that the documentation
guidelines on history and exam should be kept in their current form.
Many stakeholders believed they should be simplified or reduced, but
not eliminated. Some stakeholders indicated that the documentation
guidelines on history and exam could be eliminated altogether, and/or
that documentation of these parts of an E/M visit could be left

[[Page 59628]]

to practitioner discretion. We also heard from stakeholders that the
degree to which an extended history and exam enables a given
practitioner to reach a certain level of coding (and payment) varies
according to their specialty. Many commenters advised CMS to increase
reliance on medical decision-making (MDM) and time in determining the
appropriate level of E/M visit, or to use MDM by itself, but many of
these commenters noted that the MDM portions of the guidelines would
need to be altered before being used alone. Commenters were divided on
the role of time in distinguishing among E/M visit levels, and
expressed some concern about potential abuse or inequities among more-
or less-efficient practitioners. Some commenters expressed support for
simplifying E/M coding generally into three levels such as low, medium
and high, and potentially distinguishing those levels on the basis of
time.
2. CY 2019 Final Policies
a. Overview
Having considered the public feedback to the CY 2018 PFS proposed
rule (82 FR 53163 through 53166) and our other outreach efforts
described above, in our CY 2019 proposed rule, we proposed several
changes to E/M visit documentation and payment. We proposed that the
changes would only apply to office/outpatient visit codes (CPT codes
99201 through 99215), except where we specify otherwise. We agreed with
commenters that we should take a step-wise approach to these issues,
and therefore, we limited proposed changes to the office/outpatient E/M
code set. We understood from commenters that there are more unique
issues to consider for the E/M code sets used in other settings such as
inpatient hospital or emergency department care, such as unique
clinical and legal issues and the potential intersection with hospital
Conditions of Participation (CoPs). We may consider expanding our
efforts more broadly to address sections of the E/M code set beyond the
office/outpatient codes in future years.
We emphasized that, this year, we included our proposed E/M
documentation changes in a proposed rule due to the longstanding nature
of our instruction that practitioners may use either the 1995 or 1997
versions of the E/M guidelines to document E/M visits billed to
Medicare, the magnitude of the proposed changes, and the associated
payment policy proposals that require notice and comment rulemaking. We
believed our proposed documentation changes for E/M visits were
intrinsically related to our proposal to alter PFS payment for E/M
visits, and the PFS payment proposal for E/M visits required notice and
comment rulemaking. We noted that we were proposing a relatively broad
outline of changes, and anticipated that many details related to
program integrity and ongoing refinement would need to be developed
over time through subregulatory guidance. This would afford flexibility
and enable us to more nimbly and quickly make ongoing clarifications,
changes and refinements in response to continued practitioner
experience moving forward.
We put forth a key proposal that, at its core, strived to reduce
the significant burden associated with documentation for payment
purposes by eliminating the payment rules associated with the current
primary means of varying payment among office/outpatient visits.
Specifically, we proposed to develop single payment rates for the
office/outpatient E/M visit levels 2 through 5 (one rate for
established patients, and one rate for new patients), in order to
mitigate the need for physicians and other practitioners to adhere to
complex payment-specific documentation rules for each and every visit
furnished to a Medicare beneficiary. If there were minimal payment
variation based on the level of visit billed, then there would be
minimal need to engage with the burdensome and outdated documentation
guidelines and E/M visit coding to justify that the appropriate level
visit was reported. Though we acknowledged a continued need to document
information in the medical record for clinical and other purposes, our
understanding based on extensive feedback from medical professionals
was that the documentation specific to justifying the visit level
reported to payers, including Medicare, was unduly and
disproportionately burdensome among the many administrative burdens in
current medical practice. To avoid the administrative burden and
disruption of establishing a new G code to describe the level 2 through
5 combined visit, under our proposal practitioners would continue to
report on the claim the CPT code associated with the level of visit the
practitioner believed they furnished.
Along with eliminating payment variation for office/outpatient E/M
visit levels 2 through 5, we proposed a series of corollary policies
intended to vary payment for these visits based on a more meaningful
set of attributes for visits. Our goal was that these payment
variations, accomplished through new add-on and other coding changes,
and multiple procedure payment reductions, would reflect the relative
resource costs of furnishing E/M visits without requiring detailed
documentation for purposes of justifying particular payment rates. We
also expected these adjustments to offset some of the more significant
potentially redistributive impacts of this proposal, especially among
physicians and practitioners of different specialties. The potential
redistributive impacts helped us to determine potential, initial values
for the proposed add-on codes providing for the adjustments. Again,
these proposals were intended to provide a more meaningful avenue for
payment variation that would ease the documentation burdens currently
faced by clinicians to justify the visit level that is reported for
each and every visit with a beneficiary. These proposals reflected our
longstanding beliefs that: There are certain complexities inherent in
furnishing some kinds of E/M visits that are not currently accounted
for in valuations for the current E/M code set, there are unaccounted-
for efficiencies when E/M visits are billed on the same day as global
procedure codes that are already valued to include resources associated
with E/M services, and the current E/M coding system does not fully
account for the variety of legitimate circumstances when the needs of
individual patients require more time with their physicians. We also
proposed to establish unique E/M visit codes for podiatric care and
make changes to the PE methodology in order to standardize the amount
of PE RVUs allocated for this series of codes, regardless of which
specialties were assumed to bill them.
In conjunction with our proposal to effectively eliminate the
variation in payment of choosing from among E/M visit levels 2 through
5 for office/outpatient visits, we proposed a minimum level of
associated documentation that would apply for payment purposes across
all level 2 through 5 office/outpatient E/M visits. We also proposed to
allow practitioners a choice regarding the basis for their
documentation for these visits: Current documentation guidelines
(history, exam and MDM); MDM alone; or time alone. We proposed that,
when using current documentation guidelines or MDM, the current
guidelines for level 2 visits would apply. When using time to document
a visit, the practitioner would be required to demonstrate the medical
necessity of the visit and report the total amount of face-to-face time
they spent with the beneficiary. We solicited public comment on what
the total time

[[Page 59629]]

requirement should be when using time to document a level 2 through 5
visit. We presented several alternatives for determining the amount of
time associated with each visit level: The new intra-service times
associated with setting the payment rate for the visit codes, the
midpoint of these new times, or the typical time for the CPT code
reported on the claim (the time listed in the AMA/CPT codebook for that
code) (83 FR 35837).
We sought feedback in particular on the option to document using
time when prolonged E/M services are billed. We proposed that when a
practitioner uses time to document the visit and also reports prolonged
E/M services, we would require the practitioner to document that the
typical time required for the base or ``companion'' visit is exceeded
by the amount required to report prolonged services (83 FR 35837). We
did not propose any changes to CPT codes 99354 and 99355, and under our
proposal these codes could still be billed, as needed, when their time
thresholds and all other requirements are met (83 FR 35774).
Since we proposed to create a single payment rate under the PFS
that would be paid for services billed using the current CPT codes for
level 2 through 5 visits, it would not be material to Medicare's
payment decision which CPT code (of levels 2 through 5) would be
reported on the claim, except to justify billing a level 2 or higher
visit in comparison to a level 1 visit (providing the visit itself was
reasonable and necessary) and when using certain potential approaches
to documenting the visit using time (83 FR 35836 through 35837).
However, we expected that for record keeping purposes or to meet
requirements of other payers, practitioners would continue to choose
and report the level of E/M visit they believed to be appropriate under
the current CPT coding structure.
We also proposed to remove an existing manual provision for home
visits requiring documentation in the patient's medical record of the
medical necessity of furnishing the visit in the home. For all office/
outpatient E/M visits, we also proposed several simplifications
centered on reducing the need for duplicative, redundant data entry in
the medical record.
Several thousand commenters responded to this series of proposals.
Generally, the commenters stated appreciation for CMS' goal of reducing
administrative burden and reforming E/M coding and payment, but
expressed concern about many impacts of the proposals. Commenters
largely objected to our proposal to eliminate payment differences for
office/outpatient E/M visit levels 2 through 5 based on the level of
visit complexity. Many commenters stated that they would experience
payment cuts relative to the current payment structure. Commenters
generally stated that the implementation timeframe for the changes as
proposed was too aggressive, especially since stakeholders were
uncertain as to whether other payers would follow Medicare's proposed
policies. Many commenters suggested that CMS could implement the
proposed documentation reduction without the coding/payment policies,
or that these policies could be adopted on separate timeframes.
Many commenters suggested that the proposals did not specify the
circumstances in which the proposed add-on codes for office/outpatient
E/M visits could be used, and what documentation requirements might be
adopted for them. Many commenters stated that it would be better if the
physician community could consider a range of alternative coding and
payment options to be modeled and thoroughly evaluated over several
years instead of a single alternative during a 60-day public comment
period.
Many commenters opposed our proposal to establish that clinicians
billing an office/outpatient E/M visit level 2 through 5 need only
document medical necessity as specified for a level 2 visit (unless
time is used as the basis for the visit level). Some commenters
supported allowing a choice of documentation methodologies, while
others opposed it. The vast majority of commenters did not support
having only a single payment level to distinguish visit complexity
(other than level 1), despite the associated minimum documentation that
we proposed for these codes. Most commenters noted that CMS did not
provide enough specificity in its proposals for how clinicians would
document using time, and that because the definitions and billing rules
regarding the add-on codes were ambiguous, they questioned whether the
codes would have clinical validity. Regarding the valuation of these
services, some commenters stated that the proposal did not follow the
statutory requirement regarding using relative resources to set PFS
rates. Others perceived that some of the newly proposed codes would be
required or restricted based on physician specialty, and that such
limitations would violate statutory provisions prohibiting varying
payment for the same physicians' service by physician specialty.
Many commenters recommended that CMS finalize the documentation
proposals regarding home visits and redundant data recording for 2019,
but defer other documentation reforms to future years after
stakeholders provide additional input. Some commenters recommended that
CMS finalize the proposed choice among documentation methodologies
while stakeholders work with CMS to refine what the coding and payment
changes should be.
After considering the comments, for 2019 we are finalizing several
of our documentation proposals that will provide some significant and
immediate burden reduction, but are unrelated to changes to payment and
coding. Specifically, we are finalizing the proposals regarding home
visits and redundant data recording (discussed further in this
section), as proposed, effective January 1, 2019.
After considering the comments, especially those suggesting that
implementation of significant payment and coding changes requires time
for practitioners, vendors, health systems, and other stakeholders to
prepare, we are finalizing modified changes in payment coding, and
associated documentation rules for E/M office/outpatient visits for
2021. These changes, detailed below, incorporate many significant
changes from our proposals based on suggestions from the many comments
we received. In brief summation, we are finalizing a significant
reduction in the current payment variation in office/outpatient E/M
visit levels by paying a single rate for E/M office/outpatient visit
levels 2, 3, and 4 (one for established and another for new patients)
beginning in 2021. However, we are not finalizing the inclusion of E/M
office/outpatient level 5 visits in the single payment rate, to better
account for the care and needs of particularly complex patients. Also,
after consideration of public comments, we are not finalizing aspects
of our proposal that would have: Reduced payment when E/M office/
outpatient visits are furnished on the same day as procedures,
established separate podiatric E/M visit codes, or standardized the
allocation of PE RVUs for the codes that describe these services. We
are finalizing a policy for 2021 to adopt add-on codes that describe
the additional resources inherent in visits for primary care and
particular kinds of specialized medical care. As discussed further
below, these codes will only be reportable with E/M office/outpatient
level 2 through 4 visits, and their use generally will not impose new
per-visit documentation requirements. These codes are neither required
nor restricted by physician specialty, though we acknowledge that,

[[Page 59630]]

like many other physicians' services for which payment is made under
the PFS, they are specifically intended to describe services that
clinicians practicing in some specialties are more likely to perform
than those in other specialties. We are also finalizing a policy for
2021 to adopt a new ``extended visit'' add-on code for use only with E/
M office/outpatient level 2 through 4 visits to account for the
additional resources required when practitioners need to spend extended
time with the patient.
For CY 2019 and 2020, we will continue the current coding and
payment structure for E/M office/outpatient visits, and, therefore,
practitioners should continue to use either the 1995 or 1997 versions
of the E/M guidelines to document E/M office/outpatient visits billed
to Medicare for 2019 and 2020 (with the exception of our final policy
to eliminate redundant data recording).
Beginning in 2021, for E/M office/outpatient levels 2 through 5
visits, we will allow for flexibility in how visit levels are
documented, specifically a choice to use the current framework, MDM or
time. For E/M office/outpatient level 2 through 4 visits, beginning in
2021 we will also apply a minimum supporting documentation standard
associated with level 2 visits when practitioners use the current
framework or MDM to document the visit.
We intend to engage in further discussions with the public over the
next several years to potentially further refine our policies, through
future notice and comment rulemaking, for 2021. We discuss the public
comments, our responses to the specific concerns and perspectives
offered by commenters, and final policies in greater detail in this
section.
b. Public Comments and Responses
(1) Lifting Restrictions Related to E/M Documentation
(a) Eliminating Extra Documentation Requirements for Home Visits
Medicare pays for E/M visits furnished in the home (a private
residence) under CPT codes 99341 through 99350. The payment rates for
these codes are slightly more than for office visits (for example,
approximately $30 more for a level 5 established patient, non-
facility). The beneficiary need not be confined to the home to be
eligible for such a visit. However, there is a Medicare Claims
Processing Manual provision requiring that the medical record must
document the medical necessity of the home visit made in lieu of an
office or outpatient visit (Pub. 100-04, Medicare Claims Processing
Manual, Chapter 12, Section 30.6.14.1.B., available on the CMS website
at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/
Downloads/clm104c12.pdf). Stakeholders have suggested that whether a
visit occurs in the home or the office is best determined by the
practitioner and the patient without applying additional rules. We
agreed, so we proposed to remove the requirement that the medical
record must document the medical necessity of furnishing the visit in
the home rather than in the office. We welcomed public comments on this
proposal, including any potential, unintended consequences of
eliminating this requirement.
Comment: Commenters were generally supportive of our proposal to
remove the requirement that the medical record must document the
medical necessity of furnishing the visit in the home rather than in
the office. Many commenters included this proposal in a list of
appropriate changes CMS should make immediately regarding documentation
of E/M visits, effective January 1, 2019.
Response: We are finalizing this policy change to remove the
requirement that the medical record must document the medical necessity
of furnishing the visit in the home rather than in the office, as
proposed, effective January 1, 2019.
(b) Public Comment Solicitation on Eliminating Prohibition on Billing
Same-Day Visits by Practitioners of the Same Group and Specialty
The Medicare Claims Processing Manual states, ``As for all other E/
M services except where specifically noted, the Medicare Administrative
Contractors (MACs) may not pay two E/M office visits billed by a
physician (or physician of the same specialty from the same group
practice) for the same beneficiary on the same day unless the physician
documents that the visits were for unrelated problems in the office,
off campus-outpatient hospital, or on campus-outpatient hospital
setting which could not be provided during the same encounter'' (Pub.
100-04, Medicare Claims Processing Manual, Chapter 12, Section
30.6.7.B., available on the CMS website at https://www.cms.gov/
Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c12.pdf).
This instruction was intended to reflect the idea that multiple
visits with the same practitioner, or by practitioners in the same or
very similar specialties within a group practice, on the same day as
another E/M service would not be medically necessary. However,
stakeholders have provided a few examples where this policy does not
make sense with respect to the current practice of medicine as the
Medicare enrollment specialty does not always coincide with all areas
of medical expertise possessed by a practitioner--for example, a
practitioner with the Medicare enrollment specialty of geriatrics may
also be an endocrinologist. If such a practitioner was one of many
geriatricians in the same group practice, they would not be able to
bill separately for an E/M visit focused on a patient's
endocrinological issue if that patient had another more generalized E/M
visit by another geriatrician on the same day. Stakeholders have
pointed out that in these circumstances, practitioners often respond to
this instruction by scheduling the E/M visits on two separate days,
which could unnecessarily inconvenience the patient. Given that the
number and granularity of practitioner specialties recognized for
purposes of Medicare enrollment continue to increase over time
(consistent with the medical community's requests), the value to the
Medicare program of the prohibition on same-day E/M visits billed by
physicians in the same group and medical specialty may be diminishing,
especially as we believe it is becoming more common for practitioners
to have multiple specialty affiliations, but would have only one
primary Medicare enrollment specialty. We believe that eliminating this
policy may better recognize the changing practice of medicine while
reducing administrative burden. The impact of this proposal on program
expenditures and beneficiary cost sharing is unclear. To the extent
that many of these services are currently merely scheduled and
furnished on different days in response to the instruction, eliminating
this manual provision may not significantly increase utilization,
Medicare spending and beneficiary cost sharing.
We solicited public comment on whether we should eliminate the
manual provision given the changes in the practice of medicine or
whether there is concern that eliminating it might have unintended
consequences for practitioners and beneficiaries.
We recognize that this instruction may be appropriate only in
certain clinical situations, so we also solicited public comments on
whether and how we should consider creating exceptions to, or modify
this manual provision rather than eliminating it entirely. We also
requested that the public provide additional examples and situations in

[[Page 59631]]

which the current instruction is not clinically appropriate.
Comment: We received many comments in response to this
solicitation.
Response: We thank the commenters for all of the information
submitted, and will review the many public comments we received on this
topic and consider this issue further for potential future rulemaking.
(2) Documentation Changes for Office or Other Outpatient E/M Visits and
Home Visits
(a) Providing Choices in Documentation--Medical Decision-Making, Time
or Current Framework
Informed by comments and examples that we have received stating
that the current E/M documentation guidelines are outdated with respect
to the current practice of medicine, and in our efforts to simplify
documentation for the purposes of coding E/M visit levels, we proposed
to allow practitioners to choose, as an alternative to the current
framework specified under the 1995 or 1997 guidelines, either MDM or
time as a basis to determine the appropriate level of E/M visit. This
would allow different practitioners in different specialties to choose
to document the factor(s) that matter most given the nature of their
clinical practice. It would also reduce the impact Medicare may have on
the standardized recording of history, exam and MDM data in medical
records, since practitioners could choose to no longer document many
aspects of an E/M visit that they currently document under the 1995 or
1997 guidelines for history, physical exam and MDM. Although we
initially considered reducing the number of key components that
practitioners needed to document in choosing the appropriate level of
E/M service to bill, feedback from the stakeholder community led us to
believe that offering practitioners a choice to either retain the
current framework or choose among new options that involve a reduced
level of documentation would be less burdensome for practitioners, and
would allow more stability for practitioners who may need time to
prepare for any potential new documentation framework.
We sought to be clear that as part of this proposal, practitioners
could use MDM, or time, or they could continue to use the current
framework to document an E/M visit. In other words, we would be
offering the practitioner the choice to continue to use the current
framework by applying the 1995 or 1997 documentation guidelines for all
three key components. However, our proposals on payment for office-
based/outpatient E/M visits described later in this section would apply
to all practitioners, regardless of their selected documentation
approach. Under our proposal, all practitioners, even those choosing to
retain the current documentation framework, would be paid at the
proposed new payment rate described in the CY 2019 PFS proposed rule
(one rate for new patients and another for established patients), and
could also report applicable G-codes as we proposed (83 FR 35839
through 35843).
We also sought to be clear that we proposed to retain the current
CPT coding structure for E/M visits (along with our proposal to create
new replacement codes for podiatry office/outpatient E/M visits).
Practitioners would report on the professional claim whatever level of
visit (1 through 5) they believe they furnished using CPT codes 99201-
99215. Because we believed the adoption of replacement G-codes to
describe the visit levels 2 through 5 might result in unnecessary
disruption to current billing systems and practices, we did not propose
to modify the existing CPT coding structure for E/M visits. Since we
proposed to create a single rate under the PFS that would be paid for
services billed using the current CPT codes for level 2 through 5 E/M
visits, under our proposal, it would not have been material to
Medicare's payment decision which CPT code (of levels 2 through 5) is
reported on the claim, except to justify billing a level 2 or higher
visit in comparison to a level 1 visit (provided the visit itself was
reasonable and necessary). We stated that we expected that, for record
keeping purposes or to meet requirements of other payers, many
practitioners would continue to choose and report the level of E/M
visit they believed to be appropriate under the CPT coding structure.
Even though under our proposal, there would have been no payment
differential for E/M visits based on which of the codes describing
visit levels 2 through 5 were reported, we believed we would still need
to simplify and change our documentation requirements to better align
with the current practice of medicine and eliminate unnecessary aspects
of the current documentation framework. As a corollary to our proposal
to adopt a single payment amount for office/outpatient E/M visit levels
2 through 5 (83 FR 35839 through 35843), we proposed to apply a minimum
documentation standard where, for the purposes of PFS payment for an
office/outpatient E/M visit, practitioners would only need to meet
documentation requirements currently associated with a level 2 visit
for history, exam and/or MDM, except when using time to document the
service. Practitioners could choose to document more information for
clinical, legal, operational or other purposes, and we anticipated that
for those reasons, practitioners would continue generally to seek to
document medical record information that is consistent with the level
of care furnished. For purposes of our medical review, however, for
practitioners using the current documentation framework or, as we
proposed, MDM, Medicare would only require documentation to support the
medical necessity of the visit and the documentation that is associated
with the current level 2 CPT visit code.
For example, for a practitioner choosing to document using the
current framework (1995 or 1997 guidelines), our proposed minimum
documentation for any billed level of E/M visit from levels 2 through 5
could include: (1) A problem-focused history that does not include a
review of systems or a past, family, or social history; (2) a limited
examination of the affected body area or organ system; and (3)
straightforward medical decision making measured by minimal problems,
data review, and risk (two of these three). If the practitioner was
choosing to document based on MDM alone, Medicare would only require
documentation supporting straightforward medical decision-making
measured by minimal problems, data review, and risk (two of these
three).
Some commenters had suggested that the current framework of
guidelines for the MDM component of visits would need to be changed
before MDM could be relied upon by itself to distinguish visit levels.
We proposed to allow practitioners to rely on MDM in its current form
to document their visit, and solicited public comment on whether and
how guidelines for MDM might be changed in subsequent years.
As described earlier, we currently allow time or duration of visit
to be used as the governing factor in selecting the appropriate E/M
visit level only when counseling and/or coordination of care accounts
for more than 50 percent of the face-to-face physician/patient
encounter (or, in the case of inpatient E/M services, the floor time).
Our proposal to allow practitioners the choice of using time to
document office/outpatient E/M visits would have meant that this time-
based standard is not limited to E/M visits in which counseling and/or
care coordination

[[Page 59632]]

accounts for more than 50 percent of the face-to-face practitioner/
patient encounter. Rather, the amount of time personally spent by the
billing practitioner face-to-face with the patient could be used to
document the E/M visit regardless of the amount of counseling and/or
care coordination furnished as part of the face-to-face encounter.
Some commenters had raised concerns with reliance on time to
distinguish visit levels, for example the potential for abuse,
inequities among more- or less-efficient practitioners, and specialties
for which time is less of a factor in determining visit complexity. We
noted in the proposed rule that relying on time as the basis for
identifying the E/M visit level would also raise the issue of what
would be required by way of supporting documentation; for example, what
amount of time should be documented, and whether the specific
activities comprising the time need to be documented and to what
degree. However, a number of stakeholders had suggested that, within
their specialties, time is a good indicator of the complexity of the
visit or patient, and requested that we allow practitioners to use time
as the single factor in all E/M visits, not just when counseling or
care coordination dominate a visit. We agreed that for some
practitioners and patients, time may be a good indicator of complexity
of the visit, and proposed to allow practitioners the option to use
time as the single factor in selecting visit level and documenting the
E/M visit, regardless of whether counseling or care coordination
dominate the visit. We stated that if finalized, we would monitor the
results of this policy for any program integrity issues, administrative
burden or other issues.
For practitioners choosing to support their coding and payment for
an E/M visit by documenting the amount of time spent with the patient,
we proposed to require the practitioner to document the medical
necessity of the visit and show the total amount of time spent by the
billing practitioner face-to-face with the patient. We solicited public
comment on what that total time should be for payment of the single,
new rate for E/M visits levels 2 through 5. We presented the typical
time for our proposed new single payment for E/M visit levels 2 through
5 (the weighted average of the intra-service times across the current
E/M visit utilization) and suggested we could use this time. We noted
that currently the PFS does not require the practitioner to spend or
document a specified amount of time with a given patient in order to
receive payment for an E/M visit, unless the visit is dominated by
counseling/care coordination and, on that account, the practitioner is
using time as the basis for code selection. The times for E/M visits
and most other PFS services in the physician time files, which are used
to set PFS rates, are typical times rather than requirements, and were
recommended by the AMA RUC and then reviewed and either adopted or
adjusted for Medicare through our usual ratesetting process as
``typical,'' but not strictly required.
We presented a potential alternative to apply the AMA's CPT
codebook provision that, for timed services, a unit of time is attained
when the mid-point is passed,\5\ such that we would require
documentation that at least 16 minutes for an established patient (more
than half of 31 minutes) and at least 20 minutes for a new patient
(more than half of 38 minutes) were spent face-to-face by the billing
practitioner with the patient, to support making payment at the
proposed single rate for visit levels 2 through 5 when the practitioner
chose to document the visit using time.
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\5\ 2017 CPT Codebook Introduction, p.xv.
---------------------------------------------------------------------------

We presented another potential alternative to require documentation
that the typical time for the CPT code that is reported (which is also
the typical time listed in the AMA's CPT codebook for that code) was
spent face-to-face by the billing practitioner with the patient. For
example, a practitioner reporting CPT code 99212 (a level 2 established
patient visit) would be required to document having spent a minimum of
10 minutes, and a practitioner reporting CPT code 99214 (a level 4
established patient visit) would be required to document having spent a
minimum of 25 minutes. Under this approach, the total amount of time
spent by the billing practitioner face-to-face with the patient would
inform the level of E/M visit (of levels 2 through 5) coded by the
billing practitioner. We noted that in contrast to other proposed
documentation approaches discussed above, this approach of requiring
documentation of the typical time associated with the CPT visit code
reported on the claim would introduce unique payment implications for
reporting that code, especially when the time associated with the
billed E/M code is the basis for reporting prolonged E/M services.
We solicited public comments on the use of time as a framework for
documentation of office/outpatient E/M visits, and whether we should
adopt any of these approaches or specify other requirements with
respect to the proposed option for documentation using time.
In providing us with feedback, we requested that commenters take
into consideration ways in which the time associated with, or required
for, the billing of any add-on codes (especially the proposed prolonged
E/M visit add-on code(s) described in the CY 2019 PFS proposed rule (83
FR 35844)) would intersect with the time spent for the base E/M visit,
when the practitioner is documenting the E/M visit using only time.
Currently, when reporting prolonged E/M services, we expect the
practitioner to exceed the typical time assigned for the base E/M visit
code (also commonly referred to as the companion code). For example, in
the CY 2017 PFS final rule (81 FR 80229), we expressed appreciation for
the commenters' suggestion to display the typical times associated with
relevant services. We also discussed, and in response to those
comments, decided to post a file annually that notes the times assumed
to be typical for purposes of PFS ratesetting for practitioners to use
as a reference in deciding whether time requirements for reporting
prolonged E/M services are met. We stated that although these typical
times are not required for a practitioner to bill the displayed base
codes, we expect that only time spent in excess of these times will be
reported using a non-face-to-face prolonged service code. We proposed
to formalize this policy in the case where a practitioner uses time to
document a visit, since there would be a stricter time requirement
associated with the base E/M code. Specifically, we proposed that, when
a practitioner chooses to document using time and also reports
prolonged E/M services, we would require the practitioner to document
that the typical time required for the base or ``companion'' visit is
exceeded by the amount required to report prolonged services. Further
discussion of our proposal regarding reporting prolonged E/M services
is available in the CY 2019 PFS proposed rule (83 FR 35844).
We believed that allowing practitioners to choose the most
appropriate basis for distinguishing among the levels of E/M visits and
applying a minimum documentation requirement, together with reducing
the payment variation among E/M visit levels, would significantly
reduce administrative burden for practitioners, and would avoid the
current need to make coding and documentation decisions based on codes
and documentation guidelines that are not a good fit with current
medical practice. The practitioner could choose to use

[[Page 59633]]

MDM, time or the current documentation framework, and could also apply
the proposed policies discussed below regarding redundancy and who can
document information in the medical record.
We solicited public comment on these proposals to provide
practitioners choice in the basis for documenting E/M visits in an
effort to allow for documentation alternatives that better reflect the
current practice of medicine and to alleviate documentation burden. We
stated our interest in receiving public comments on practitioners'
ability to avail themselves of these choices for how they would impact
clinical workflows, EHR templates, and other aspects of practitioner
work.
Stakeholders had requested that CMS not merely shift burden by
implementing another framework that might avoid issues caused by the
current guidelines, but that would be equally complex and burdensome.
Our primary goal was to reduce administrative burden so that the
practitioner can focus on the patient, and we were interested in
commenters' opinions as to whether our E/M visit proposals would, in
fact, support and further this goal. We believed our proposals would
allow practitioners to exercise greater clinical judgment and
discretion in what they document, focusing on what is clinically
relevant and medically necessary for the patient rather than what will
illustrate that the appropriate visit level was reported. Although we
proposed to no longer apply much of the E/M documentation guidelines
involving history, physical exam and, for those choosing to document
based on time, documentation of medical decision-making, we stated our
expectation that practitioners would continue to perform as medically
necessary for the patient and document E/M visits to ensure quality and
continuity of care. For example, we believed that it remains an
important part of care for the practitioner to understand the patient's
social history, even though certain documentation options we proposed
would no longer require that history to be re-documented to bill
Medicare for the visit.
Comment: Many commenters supported the proposal to allow choice in
documentation between the current framework, medical decision making or
time. However, some commenters stated that such a policy would
introduce too much variation in medical record format and content, or
too many potential frameworks against which an auditor might review a
claim. Commenters were unsure whether CMS envisioned the choice being
made on a case-by-case basis or with some regularity. Other commenters
noted that time alone is not an accurate measure of visit complexity or
would be subject to gaming, or that CMS did not provide enough detail
regarding time thresholds and documentation requirements to allow them
to assess potential impact.
Many of the commenters did not support the proposal, as a corollary
to our proposal to adopt a single payment amount for office-outpatient
E/M visit levels 2 through 5, to apply a minimum level 2 documentation
standard. These commenters were concerned that this standard would
result in inadequate documentation for patient care, legal and other
purposes. They noted that CMS overestimated the associated reduction in
burden that would result from this proposal, and instead believe the
level 2 documentation standard would reduce burden to a lesser degree
than we estimated, or potentially increase burden. They indicated that
there would be costs in terms of time and resources to update EHRs and
train staff, and that they expected there would be the need to continue
documenting many elements included in the current code definitions for
patient care and other purposes, including other payers. Many
commenters expressed concern that the documentation could potentially
increase due to misalignment in documentation rules between payers, as
they presume that Medicaid, commercial payers and secondary payers
would not likely adopt Medicare's payment changes, at least not
immediately. Several commercial payers or their associations expressed
similar concerns and recommended implementing a more limited set of
documentation changes and ongoing monitoring.
MedPAC and a few other commenters recommended paying for visits on
the basis of time alone. MedPAC recommended requiring the time spent to
be reported on the claim so CMS can collect data on current times
actually spent and use it to more accurately set rates in the future.
A few commenters indicated what the time requirement should be when
using time to document. Most of these commenters noted that CMS should
require the typical time associated with the CPT code reported on the
claim. One commenter who opposed the single payment rate stated that if
CMS did finalize a single payment rate, then CMS should require only
the time associated with the level 2 CPT codes (10 minutes for an
established patient and 20 minutes for a new patient). Some commenters
expressed support for requiring that this time be spent by the billing
practitioner face-to-face with the patient, and a few commenters
expressed support for allowing time spent by individuals other than the
billing practitioner and/or time spent furnishing non-face-to-face care
to count.
Response: For CY 2019 and 2020, we will continue the current coding
and payment structure for E/M office/outpatient visits, and, therefore,
practitioners should continue to use either the 1995 or 1997 versions
of the E/M guidelines to document E/M office/outpatient visits billed
to Medicare for 2019 and 2020 (with the exception of our final policy
to eliminate redundant data recording).
We appreciate the issues raised by commenters but continue to
believe our proposals allowing for flexibility in how E/M office/
outpatient visit levels are documented and the applying of a minimum
documentation standard as a corollary to establishing single payment
rates for E/M office/outpatient visits will significantly reduce burden
for clinicians and support them in making coding and documentation
decisions that better align with current medical practice. Beginning in
2021, for E/M office/outpatient levels 2 through 5 visits, we will
allow for flexibility in how visit levels are documented, allowing
billing practitioners the choice to use the current framework, MDM or
time. Specifically, for level 5 visits, for PFS payment purposes a
practitioner can use the current framework with the documentation
requirements applicable to a level 5 visit or the current definition of
level 5 MDM. As an another alternative, the practitioner can document
using time, which will require documentation of the medical necessity
of the visit and that the billing practitioner personally spent at
least the typical time associated with the level 5 CPT code that is
reported face-to-face with the patient (40 minutes for an established
patient and 60 minutes for a new patient). Since there will be no new
intra-service time associated with the level 5 visit codes, we are
finalizing our proposed alternative to use the typical time associated
with the CPT code reported on the claim, consistent with current policy
when counseling and/or coordination of care accounts for more than 50
percent of the face-to-face physician/patient encounter.
For E/M office/outpatient level 2 through 4 visits, in 2021 we will
also allow choice of documentation methodology (current framework, MDM
or time). For practitioners using the current documentation framework
or

[[Page 59634]]

MDM, for PFS payment purposes, we will apply a minimum supporting
documentation standard associated with E/M office/outpatient level 2
visits such that we only require documentation that is associated with
the current level 2 CPT visit code (new or established patient, as
applicable). For example, if the practitioner is choosing to document
based on MDM alone, for PFS payment purposes we will only require
documentation supporting straight forward medical decision-making
measured by minimal problems, data review, and risk (two of these
three). If choosing to document using time, for PFS payment purposes we
will require the billing practitioner to document that the visit was
medically reasonable and necessary and that the billing practitioner
personally spent the current typical time for the CPT code reported
(for example, 15 minutes when reporting CPT code 99213 (a level 3
established patient visit)). For administrative simplicity, it may be
most straight forward to track to the typical time for the CPT code.
We address the public comments on our burden reduction estimate and
changes to our estimate based on our final policies further below (see
section VII. of this final rule, Regulatory Impact Analysis). We intend
to engage in further discussions with the public over the next several
years to potentially further refine our policies for 2021.
As we noted in the CY 2019 PFS proposed rule, we heard from a few
commenters on the CY 2018 PFS proposed rule that some practitioners
rely on unofficial Marshfield clinic or other criteria to help them
document E/M visit levels. These commenters conveyed that the
Marshfield ``point system'' is commonly used to supplement the E/M
documentation guidelines, because of a lack of concrete criteria for
certain elements of medical decision making in the 1995 and 1997
guidelines or in CPT guidance. Accordingly, in the CY 2019 PFS proposed
rule, we solicited public comment on whether Medicare should use or
adopt any aspects of other E/M documentation systems that may be in use
among practitioners, such as the Marshfield tool. We were interested in
feedback as to whether the 1995 and 1997 guidelines contain adequate
information for practitioners to use in documenting visits under our
proposals, or whether these versions of the guidelines would need to be
supplemented in any way.
The following is a summary of the comments we received on whether
Medicare should use or adopt any aspects of other E/M documentation
systems that may be in use among practitioners, such as the Marshfield
tool, and also whether the 1995 and 1997 guidelines contain adequate
information for practitioners to use in documenting visits under our
proposals, or whether these versions of the guidelines would need to be
supplemented in any way.
Comment: We received a few comments clarifying how the Marshfield
tool is currently used, but the commenters provided reasons not to use
it as a replacement standard for current measures of visit complexity
specified in the 1995 and 1997 documentation guidelines. A few
commenters suggested new methods that could be used to support the
level of E/M visit reported, such as risk adjustment with CMS's
Hierarchical Condition Category scores used in Medicare Advantage; and
some commenters recommended that CMS use medical decision making alone
or in combination with time to distinguish visit/patient complexity. A
few commenters recommended ways in which medical decision making could
be relied upon, and ways that it should be changed, suggesting that
history and physical exam might be incorporated with medical decision
making. Many commenters recommended that CMS should continue to work
with the AMA/CPT, specialty associations and other stakeholders to come
up with revised measures of visit complexity, recommending between
three to five levels.
Response: We appreciate commenters' feedback on this solicitation,
and we considered it in the context of making a final decision. As
stated previously, we are finalizing a significant reduction in the
current payment variation in office/outpatient E/M visit levels by
paying a single rate for E/M office/outpatient visit levels 2, 3, and 4
(one for established and another for new patients). However, we are not
finalizing the inclusion of E/M office/outpatient level 5 visits in the
single payment rate, in order to better account for the care and needs
of particularly complex patients. Beginning in 2021, for E/M office/
outpatient levels 2 through 5 visits, we will allow for flexibility in
how visit levels are documented, specifically a choice to use the
current framework, MDM or time, discussed previously. For E/M office/
outpatient level 2 through 4 visits, in 2021 we will also apply a
minimum supporting documentation standard associated with level 2
visits, also discussed previously. We intend to engage in further
discussions with the public over the next several years to potentially
further refine our policies for 2021.
(b) Removing Redundancy in E/M Visit Documentation
Stakeholders have recently expressed that CMS should not require
documentation of information in the billing practitioner's note that is
already present in the medical record, particularly with regard to
history and exam. Currently, both the 1995 and 1997 guidelines provide
such flexibility for certain parts of the history for established
patients, stating, ``A Review of Systems ``ROS'' and/or a pertinent
past, family, and/or social history (PFSH) obtained during an earlier
encounter does not need to be re-recorded if there is evidence that the
physician reviewed and updated the previous information. This may occur
when a physician updates his/her own record or in an institutional
setting or group practice where many physicians use a common record.
The review and update may be documented by:
Describing any new ROS and/or PFSH information or noting
there has been no change in the information; and
Noting the date and location of the earlier ROS and/or
PFSH.
Documentation Guidelines ``DG'': The ROS and/or PFSH may be
recorded by ancillary staff or on a form completed by the patient. To
document that the physician reviewed the information, there must be a
notation supplementing or confirming the information recorded by others
(https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-
MLN/MLNEdWebGuide/Downloads/95Docguidelines.pdf; https://www.cms.gov/
Outreach-and-Education/Medicare-Learning-Network-MLN/MLNEdWebGuide/
Downloads/97Docguidelines.pdf).
We proposed to expand this policy to further simplify the
documentation of history and exam for established patients such that,
for both of these key components, when relevant information is already
contained in the medical record, practitioners would only be required
to focus their documentation on what has changed since the last visit
or on pertinent items that have not changed, rather than re-documenting
a defined list of required elements such as review of a specified
number of systems and family/social history. Practitioners would still
review prior data, update as necessary, and indicate in the medical
record that they had done so. Practitioners would conduct clinically
relevant and medically necessary elements of history and physical exam,
and conform to the general principles of medical record documentation
in the 1995 and 1997 guidelines. However,

[[Page 59635]]

practitioners would not need to re-record these elements (or parts
thereof) if there is evidence that the practitioner reviewed and
updated the previous information.
Comment: Commenters were very supportive of this proposal. Many
commenters included this proposal in a list of appropriate changes CMS
should make immediately regarding documentation of E/M visits,
effective January 1, 2019.
Response: We are finalizing this policy to simplify the
documentation of history and exam for established patients for E/M
office/outpatient visits as proposed, effective January 1, 2019.
Accordingly, when relevant information is already contained in the
medical record, practitioners may choose to focus their documentation
on what has changed since the last visit, or on pertinent items that
have not changed, and need not re-record the defined list of required
elements if there is evidence that the practitioner reviewed the
previous information and updated it as needed. Practitioners should
still review prior data, update as necessary, and indicate in the
medical record that they have done so. We note that this policy to
simplify and reduce redundancy in documentation is optional for
practitioners, and they may choose to continue the current process of
entering, re-entering and bringing forward information (83 FR 35838).
The option to continue current documentation processes may be
particularly important for practitioners who lack time to adjust
workflows, templates and other aspects of their work by January 1,
2019.
We solicited comment on whether there may be ways to implement a
similar provision for any aspects of medical decision-making, or for
new patients, such as when prior data is available to the billing
practitioner through an interoperable EHR or other data exchange. We
stated our belief that there would be special challenges in realizing
documentation efficiencies with new patients, since they may not have
received exams or histories that were complete or relevant to the
current complaint(s), and the information in the transferred record
could be more likely to be incomplete, outdated or inaccurate.
Comment: A few commenters indicated that there might be ways to
recognize some documentation efficiencies for referred new patients or
situations where data are available through an interoperable EHR, but
did not provide detail about what kinds of data are commonly available
and how they might be relevant to the receiving practitioner for
purposes of visit documentation.
Response: We appreciate the commenters' feedback in this area and
will continue to consider this issue.
We similarly proposed that for both new and established patients,
practitioners would no longer be required to re-enter information in
the medical record regarding the chief complaint and history that are
already entered by ancillary staff or the beneficiary. The practitioner
could simply indicate in the medical record that they reviewed and
verified this information. Our goal was to allow practitioners more
flexibility to exercise greater clinical judgment and discretion in
what they document, focusing on what is clinically relevant and
medically necessary for the patient.
Comment: Commenters were very supportive of this proposal. Many
commenters included this proposal in a list of appropriate changes CMS
should make immediately regarding documentation of E/M visits,
effective January 1, 2019.
Response: We are finalizing our proposal that, effective January 1,
2019, for new and established patients for E/M office/outpatient
visits, practitioners need not re-enter in the medical record
information on the patient's chief complaint and history that has
already been entered by ancillary staff or the beneficiary. The
practitioner may simply indicate in the medical record that he or she
reviewed and verified this information. We note that this policy to
simplify and reduce redundancy in documentation is optional for
practitioners, and they may choose to continue the current process of
entering, re-entering and bringing forward information (83 FR 35838).
The option to continue current documentation processes may be
particularly important for practitioners who lack time to adjust
workflows, templates and other aspects of their work by January 1,
2019.
(c) Podiatry Visits
As described in the CY 2019 PFS proposed rule (83 FR 35843), as
part of our proposal to improve payment accuracy by creating a single
PFS payment rate for E/M visit levels 2 through 5 (with one proposed
rate for new patients and one proposed rate for established patients),
we proposed to create separate coding for podiatry visits that are
currently reported as E/M office/outpatient visits. We proposed that,
rather than reporting visits under the general E/M office/outpatient
visit code set, podiatrists would instead report visits under new G-
codes that more specifically identify and value their services. We
proposed to apply substantially the same documentation standards for
these proposed new podiatry-specific codes as we proposed for other
office/outpatient E/M visits.
If a practitioner chose to use time to document a podiatry office/
outpatient E/M visit, we proposed to apply substantially the same rules
as those we proposed for documenting on the basis of time for other
office/outpatient E/M visits. For practitioners choosing to use time to
provide supporting documentation for the podiatry visit, we would
require documentation supporting the medical necessity of the visit and
showing the total amount of time spent by the billing practitioner
face-to-face with the patient. We solicited public comment on what that
total time would be for payment of the proposed new podiatry G-codes.
The typical times for these proposed codes were 22 minutes for an
established patient and 28 minutes for a new patient, and we noted we
could use these times. Alternatively, we noted we could apply the AMA's
CPT codebook provision that, for timed services, a unit of time is
attained when the mid-point is passed,\6\ such that we would require
documentation that at least 12 minutes for an established patient (more
than half of 22 minutes) or at least 15 minutes for a new patient (more
than half of 28 minutes) were spent face-to-face by the billing
practitioner with the patient, to support making payment for these
codes when the practitioner chose to document the visit using time. We
solicited comment on the use of time as a basis for documentation of
our proposed podiatric E/M visit codes, and whether we should adopt any
of these approaches or further specify other requirements with respect
to this proposed option for podiatric practitioners to document their
visits using time.
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\6\ 2017 CPT Codebook Introduction, p.xv.
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Comment: We did not receive any comments on how the proposed
podiatric codes should be documented. A few commenters noted that our
proposal to apply the same documentation rules to the proposed new
podiatric codes as for all other office/outpatient E/M visits
demonstrated that these visits were essentially the same, and that
podiatry should not be singled out for the creation of separate codes.
Response: We believe the absence of comments on our proposals for
documentation of the proposed podiatric codes is due to a lack of
general support for creation of the new

[[Page 59636]]

codes to describe podiatric E/M visits, as noted below in the comment
summary on that topic. As discussed below, we are not finalizing our
proposal to create new codes to describe podiatric E/M visits, and
accordingly, we are not finalizing any rules regarding documentation of
those codes.
(3) Minimizing Documentation Requirements by Simplifying Payment
Amounts
As we have explained above, and in prior rulemaking, we believe
that the coding, payment, and documentation requirements for E/M visits
are overly burdensome and no longer aligned with the current practice
of medicine. We believe the current set of 10 CPT codes for new and
established office-based and outpatient E/M visits and their respective
payment rates no longer appropriately reflect the complete range of
services and resource costs associated with furnishing E/M services to
all patients across the different physician specialties, and that
documenting these services using the current guidelines has become
burdensome and out of step with the current practice of medicine. To
alleviate the effects and mitigate the burden associated with continued
use of the outdated CPT code set, we proposed to simplify the office-
based and outpatient E/M payment rates and documentation requirements,
and create new add-on codes to better capture the differential
resources involved in furnishing certain types of E/M visits.
In conjunction with our proposal to reduce the documentation
requirements for E/M visit levels 2 through 5, we proposed to simplify
the payment for those services by paying a single rate for the level 2
through 5 E/M visits. The visit level of the E/M service is tied to the
documentation requirements in the 1995 and 1997 Documentation
Guidelines for E/M Services, which may not be reflective of changes in
technology or, in particular, the ways that electronic medical records
have changed documentation and the patient's medical record.
Additionally, current documentation requirements may not account for
changes in care delivery, such as a growing emphasis on team based
care, increases in the number of recognized chronic conditions, or
increased emphasis on access to behavioral health care. However, based
on the feedback we have received from stakeholders, it was clear to us
that the burdens associated with documenting the selection of the level
of E/M service arise from not only the documentation guidelines, but
also from the coding structure itself. Like the documentation
guidelines, the distinctions between visit levels reflect a reasonable
assessment of variations in care, effort, and resource costs as
identified and articulated several decades ago. We believed that the
most important distinctions between the kinds of visits furnished to
Medicare beneficiaries are not well reflected by the current E/M visit
coding. Most significantly, we have understood from stakeholders that
current E/M coding does not reflect important distinctions in services
and differences in resources. At present, we believed the current
payment for E/M visit levels, generally distinguished by common
elements of patient history, physical exam, and MDM, that may have been
good approximations for important distinctions in resource costs
between kinds of visits in the 1990s, when the CPT developed the E/M
code set, are increasingly outdated in the context of changing models
of care and information technologies.
As described earlier in this section, we proposed to change the
documentation requirements for E/M levels such that practitioners have
the choice to use the 1995 guidelines, 1997 guidelines, time, or MDM to
determine the E/M level. We believed that these proposed changes would
better reflect the current practice of medicine and represent
significant reductions in burdens associated with documenting visits
using the current set of E/M codes.
In alignment with our proposed documentation changes, we proposed
to develop a single set of RVUs under the PFS for E/M office-based and
outpatient visit levels 2 through 5 for new patients (CPT codes 99202
through 99205) and a single set of RVUs for visit levels 2 through 5
for established patients (CPT codes 99212 through 99215). Although we
considered creating new HCPCS G-codes that would describe the services
associated with these proposed payment rates, given the wide and
longstanding use of these visit codes by both Medicare and private
payers, we believed it would have created unnecessary administrative
burden to propose new coding. Therefore, we instead proposed to
maintain the current code set. Of the five levels of office-based and
outpatient E/M visits, the vast majority of visits are reported as
levels 3 and 4. In CY 2016, CPT codes 99203 and 99204 (or E/M visit
level 3 and level 4 for new patients) made up around 32 percent and 44
percent, respectively, of the total allowed charges for CPT codes
99201-99205. In the same year, CPT codes 99213 and 99214 (or E/M visit
level 3 and 4 for established patients) made up around 39 percent and
50 percent, respectively, of the allowed charges for CPT codes 99211-
99215. If our proposals to simplify the documentation requirements and
to pay a single PFS rate for new patient E/M visit levels 2 through 5
and a single rate for established patient E/M visit levels 2 through 5
were finalized, practitioners would still bill the CPT code for
whichever level of E/M service they furnished and they would be paid at
the single PFS rate. However, we believed that eliminating the
distinction in payment between visit levels 2 through 5 would eliminate
the need to audit against the visit levels, and therefore, would
provide immediate relief from the burden of documentation. A single
payment rate would also eliminate the increasingly outdated distinction
between the kinds of visits that are reflected in the current CPT code
levels in both the coding and the associated documentation rules.
In order to set RVUs for the proposed single payment rate for new
and established patient office/outpatient E/M visit codes, we proposed
to develop resource inputs based on the current inputs for the
individual E/M codes, generally weighted by the frequency at which they
are currently billed, based on the 5 most recent years of Medicare
claims data (CY 2012 through CY 2017). Specifically, we proposed a work
RVU of 1.90 for CPT codes 99202 through 99205, a physician time of
37.79 minutes, and direct PE inputs that sum to $24.98, each based on
an average of the current inputs for the individual codes weighted by 5
years of accumulated utilization data. Similarly, we proposed a work
RVU of 1.22 for CPT codes 99212 through 99215, with a physician time of
31.31 minutes and direct PE inputs that sum to $20.70. These inputs
were based on an average of the inputs for the individual codes,
weighted by volume based on utilization data from the past 5 years (CY
2012 through CY 2017). Tables 19 and 20 reflect the payment rates in
dollars that would result from the approach described above were it to
have been implemented for CY 2018. In other words, the dollar amounts
in the charts below reflect how the changes we proposed for CY 2019
would have impacted payment rates for CY 2018.

[[Page 59637]]

Table 19--Preliminary Comparison of Payment Rates for Office Visits
[New patients]
------------------------------------------------------------------------
CY 2018 non-
CY 2018 facility
non- payment rate
HCPCS code facility under the
payment proposed
rate methodology
------------------------------------------------------------------------
99201......................................... $45 $44
99202......................................... 76 135
99203......................................... 110
99204......................................... 167
99205......................................... 211
------------------------------------------------------------------------

Table 20--Preliminary Comparison of Payment Rates for Office Visits
[Established patients]
------------------------------------------------------------------------
Current
non- Proposed non-
HCPCS code facility facility
payment payment rate
rate
------------------------------------------------------------------------
99211......................................... $22 $24
99212......................................... 45 93
99213......................................... 74
99214......................................... 109
99215......................................... 148
------------------------------------------------------------------------

Although we believed that the proposed rates for E/M visit levels 2
through 5 represent the valuation of a typical E/M service, we also
recognized that the current E/M code set itself does not appropriately
reflect differences in resource costs between certain types of E/M
visits. As a result, we believed that the way we currently value the
resource costs for E/M services through the existing HCPCS CPT code set
for office-based and outpatient E/M visits does not appropriately
reflect the resources used in furnishing the range of E/M services that
are provided through the current the practice of medicine. Based on
stakeholder comments and examples and our review of the literature on
E/M services, we identified three types of E/M visits that differ from
the typical E/M visit and are not appropriately reflected in the
current office/outpatient E/M code set and valuation. Rather, these
three types of E/M visits can be distinguished by the mode of care
provided and, as a result, have different resource costs. The three
types of E/M visits that differ from the typical E/M service are (1)
separately identifiable E/M visits furnished in conjunction with a
global procedure, (2) primary care E/M visits for continuous patient
care, and (3) certain types of specialist E/M visits, including those
with inherent visit complexity. We addressed each of these
distinguishable visit types in the proposed rule.
The following is a summary of the comments we received on the
proposed blended payment rate for new and established office/outpatient
E/M visit levels 2 through 5.
Comment: While many commenters agreed that the current E/M coding
for office/outpatient visits is flawed and some agreed that the current
coding and valuation systematically undervalues primary care visits and
visits furnished in the context of non-procedural specialty care, most
commenters opposed this proposal. Many commenters stated that using a
single payment rate for new and established office/outpatient E/M visit
levels 2 through 5 could have highly variable negative repercussions at
the specialty, practice, and practitioner level. Some commenters
suggested that the proposed single payment rate for these visits was
inherently not resource-based. Many commenters stated that the proposed
single payment rate that did not vary based on patient complexity from
levels 2 through 5 was insufficient to account for the resource
differential associated with treating complex patients, and that,
without accurate payment, physicians would be likely to either schedule
multiple visits or stop taking on complex patients all together.
The few commenters who supported the proposal stated that the
negative payment implications of the single proposed payment rate are
outweighed by the reduction in documentation burden. While
acknowledging that the initial years following adoption of a single
payment rate for the level 2 through 5 E/M visit codes would be
challenging, these commenters noted that over time, potential
reductions in payment would be offset by the time saved from
unnecessary documentation. Other commenters, while urging CMS not to
finalize the proposed single payment rate for these codes, did provide
suggested alternative coding structures. Of these comments, there was a
consensus that three levels of coding for office and outpatient E/M
services is preferable to two, whether that be accomplished through
blended payment rates for levels 2 through 3 and 4 through 5, or
through a blended rate for levels 2 through 4. Most commenters pointed
to the joint CPT/AMA E/M workgroup formed in response to CMS' proposal,
and urged CMS to wait for forthcoming coding and documentation
definitions generated by that group and recommendations regarding
valuation developed through the RUC process.
Response: We appreciate the number and broad range of interested
commenters who responded to our proposal. After reviewing all of the
comments received, we understand the broad consensus regarding the
potential negative implications of the proposal for patients with the
most complex needs and the clinicians who serve them. In attempting to
eliminate the reliance on the current outmoded E/M coding structure as
it is used for purposes of payment, we recognize that the alternative
coding and payment structure we proposed lacked an element that we
agree is critical in making accurate payment: Namely, accounting for
resource costs for the most complex patients. While we believe that our
proposal to address the inherent complexity involved in furnishing
certain kinds of care combined with our proposed payment for visits
that take additional time might have accounted for a significant
portion of the resource costs associated with particularly complex
patients, we recognize the concerns expressed by commenters that these
payment adjustments might be insufficient in some cases. We also
recognize the potential negative consequences to clinicians and access
to care that could result if we do not ensure that coding and payment
appropriately account for patients with the most complex needs.
We do not believe, however, that appropriate care for complex
patients currently requiring visit levels 2 through 4 are nearly as
dependent on the current payment variations for these services. Given
that the significant majority of the volume is concentrated in the
level 3 and 4 new and established patient visits, we believe the
concerns expressed by commenters about potential shifts in practitioner
behavior would be likely to occur. We believe it would simply not be
practical for clinicians to prioritize seeing the relatively few
potential patients requiring level 2 visits in order to maximize their
revenue relative to per patient costs. Likewise, because the level 4
established patient E/M visit is the most commonly reported code among
the 5 levels for both new and established patients, any effort to avoid
treating patients requiring care that is currently reported as a level
4 visit would likely result in significantly reduced volume and overall
revenue for physician practices. We will, however, monitor utilization
of these services and make any necessary adjustments through future
rulemaking. Additionally, we recognize that because level 5 visits
represent a very small proportion of visits reported under current E/M
coding, maintaining

[[Page 59638]]

differential payment rates and documentation for these visits will
strike an appropriate balance, simplifying and reducing the burden in
distinguishing among CPT codes for the vast majority of E/M visits,
while retaining a separate payment rate for the level of care furnished
to the most complex patients.
On that basis, we are finalizing for 2021, a single payment rate
for levels 2 through 4 E/M office/outpatient visits (one rate for new,
and one for established patients) and maintaining separate payment
rates for new and established patients for level 5 E/M office/
outpatient visits to account for the most complex patients and visits.
We are finalizing a policy, modified from our proposal, to develop a
set of single payment rates for visit levels 2 through 4 (one each for
new and established patients), instead of levels 2 through 5, as
proposed. We are finalizing development of payment rates for levels 2
through 4 visits using the weighted average of the current inputs (work
RVUs, direct PE inputs, time and specialty mix) assigned to the
individual codes, based on the most recent 5 years of utilization for
each of the constituent codes. For the level 1 and level 5 office/
outpatient E/M visits we are finalizing payment rates that rely on
current inputs. The inputs we will use (in the absence of intervening
changes to CPT coding or the development of other considerations) to
develop proposed values for these services for 2021 appear in the Table
21.

Table 21--Finalized Inputs for E/M Office/Outpatient Codes for 2021
----------------------------------------------------------------------------------------------------------------
Physician Malpractice Sum of direct
HCPCS time Work RVU RVU PE inputs
----------------------------------------------------------------------------------------------------------------
99201........................................... 17.00 0.48 0.05 $13.97
99202........................................... 34.43 1.76 0.17 24.37
99203........................................... 34.43 1.76 0.17 24.37
99204........................................... 34.43 1.76 0.17 24.37
99205........................................... 67.00 3.17 0.28 30.92
99211........................................... 7.00 0.18 0.01 11.31
99212........................................... 30.26 1.18 0.08 20.41
99213........................................... 30.26 1.18 0.08 20.41
99214........................................... 30.26 1.18 0.08 20.41
99215........................................... 55.00 2.11 0.14 27.83
----------------------------------------------------------------------------------------------------------------

We are also finalizing separate, add-on payments for visit
complexity inherently associated with primary care and non-procedural
specialty care, as well as separate payment for extended visits via
HCPCS G-codes. These codes and the associated policies will be
discussed in greater detail in the discussion below. We recognize that
many commenters, including the AMA, the RUC, and specialties that
participate as members in those committees, have stated intentions of
the AMA and the CPT Editorial Panel to revisit coding for E/M office/
outpatient services in the immediate future. We note that the 2-year
delay in implementation will provide the opportunity for us to respond
to the work done by the AMA and the CPT Editorial Panel, as well as
other stakeholders. We will consider any changes that are made to CPT
coding for E/M services, and recommendations regarding appropriate
valuation of new or revised codes, through our annual rulemaking
process.
(4) Recognizing the Resource Costs for Different Types of E/M Visits
As a corollary to our proposal to adopt a single payment rate for
office and outpatient E/M services for level 2 through 5 E/M visits, we
stated that we could better capture differential resource costs and
minimize reporting and documentation burden by proposing several
additional payment policies and ratesetting adjustments. These
additional proposals were intended to reflect the important
distinctions between the kinds of visits furnished to Medicare
beneficiaries, and to reduce the burden of billing and documentation
rules to effectuate payment.
In response to the CY 2018 comment solicitation on burden reduction
for E/M visits (82 FR 53163 through 53166), we received several
comments that highlighted the inadequacy of the E/M code set to
accurately pay for the resources associated with furnishing visits,
particularly for primary care visits, and visits associated with
treating patients with particular conditions for which there is not
additional procedural coding. One commenter stated that the current
structure and valuation of the E/M code set inadequately describes the
range of services provided by different specialties, and in particular
primary care services. This commenter noted that although the 10
office/outpatient E/M codes make up the bulk of the services reported
by primary care practitioners, the valuation does not reflect their
particular resource costs. Another commenter pointed out that for
specialties that principally rely on E/M visit codes to bill for their
professional services, the complex medical decision making and the
intensity of their visits is not reflected in the E/M code set or
documentation guidelines.
In view of the comments we received, we proposed the following
adjustments to better capture the variety of resource costs associated
with different types of care provided in E/M visits: (1) An E/M
multiple procedure payment adjustment to account for duplicative
resource costs when E/M visits and procedures with global periods are
furnished together; (2) HCPCS G-code add-ons to recognize additional
relative resources for primary care visits and inherent visit
complexity that require additional work beyond that which is accounted
for in the single payment rates for new and established patient levels
2 through level 5 visits; (3) HCPCS G-codes to describe podiatric E/M
visits; (4) an additional prolonged face-to-face services add-on HCPCS
G-code; and (5) a technical modification to the PE methodology to
stabilize the allocation of indirect PE for visit services.
(a) Accounting for E/M Resource Overlap Between Stand-Alone Visits and
Global Periods
Under the PFS, E/M services are generally paid in one of two ways:
As standalone visits using E/M visit codes, or included in global
procedural codes. In both cases, RVUs are allocated to the services to
account for the estimated relative resources involved in furnishing
professional E/M services. In the case of procedural codes with global
periods,

[[Page 59639]]

the overall resource inputs reflect the costs of the E/M work
considered to be typically furnished with the procedure. Therefore, the
standalone E/M visit codes are not billable on the same day as the
procedure codes unless the billing professional specifically indicates
that the visit is separately identifiable from the procedure.
In cases where a physician furnishes a separately identifiable E/M
visit to a beneficiary on the same day as a procedure, payment for the
procedure and the E/M visit is based on rates generally developed under
the assumption that these services are typically furnished
independently. In CY 2017 PFS rulemaking, we noted that the current
valuation for services with global periods may not accurately reflect
much of the overlap in resource costs (81 FR 80209). We were
particularly concerned that when a standalone E/M visit occurs on the
same day as a 0-day global procedure, there are significant overlapping
resource costs that are not accounted for. We believe that separately
identifiable visits occurring on the same day as 0-day global
procedures have resources that are sufficiently distinct from the costs
associated with furnishing one of the 10 office/outpatient E/M visits
to warrant payment adjustment. There are other existing policies under
the PFS where we reduce payments if multiple procedures are furnished
on the same day to the same patient. Medicare has a longstanding policy
to reduce payment by 50 percent for the second and subsequent surgical
procedures furnished to the same patient by the same physician on the
same day, largely based on the presence of efficiencies in PE and pre-
and post-surgical physician work. Effective January 1, 1995, the MPPR
policy, with the same percentage reduction, was extended to nuclear
medicine diagnostic procedures (CPT codes 78306, 78320, 78802, 78803,
78806, and 78807). In the CY 1995 PFS final rule with comment period
(59 FR 63410), we indicated that we would consider applying the policy
to other diagnostic tests in the future. In the CYs 2009 and 2010 PFS
proposed rules (73 FR 38586 and 74 FR 33554, respectively), we stated
that we planned to analyze nonsurgical services commonly furnished
together (for example, 60 to 75 percent of the time) to assess whether
an expansion of the MPPR policy could be warranted. MedPAC encouraged
us to consider duplicative physician work, as well as PE, in any
expansion of the MPPR policy. Finally, in the CY 2011 PFS final rule
with comment period, CMS finalized the application of the MPPR to
always-therapy services on the justification that there was significant
overlap in the PE portion of these services (75 FR 73233).
Using the surgical MPPR as a template, we proposed that, as part of
our proposal to make payment for the E/M levels 2 through 5 at a single
PFS rate, we would reduce payment by 50 percent for the least expensive
global procedure or visit that the same physician (or a physician in
the same group practice) furnishes on the same day as a separately
identifiable E/M visit, currently identified on the claim by an
appended modifier -25. We believed that the efficiencies associated
with furnishing an E/M visit in combination with a same-day global
procedure were similar enough to those accounted for by the surgical
MPPR to merit a reduction in the relative resources of 50 percent. We
estimated that, based on CY 2017 Medicare claims data, applying a 50
percent MPPR to E/M visits furnished as separately identifiable
services on the same day as a global procedure would reduce
expenditures under the PFS by approximately 6.7 million RVUs. To
accurately reflect resource costs of the different types of E/M visits
that we previously identified while maintaining work budget neutrality
within this proposal, we proposed to allocate those RVUs toward the
values of the add-on codes that reflect the additional resources
associated with E/M visits for primary care and inherent visit
complexity, similar to existing policies. As we articulated in the CY
2012 PFS final rule with comment period, where the aggregate work RVUs
within a code family change but the overall actual physician work
associated with those services does not change, we make work budget
neutrality adjustments to hold the aggregate work RVUs constant within
the code family, while maintaining the relativity of values for the
individual codes within that set (76 FR 73105).
Comment: Many commenters opposed this proposal. Commenters
generally objected to the underlying principle of the application of an
MPPR to office/outpatient E/M codes billed on the same day as a minor
procedure. Many of these commenters stated that the current billing
rules allow these services to be billed only when modifier -25 is used,
and that modifier makes it clear that the visits are significant and
separately identifiable. Consequently, these commenters stated that no
payment adjustment should apply. Many commenters pointed to the RUC
review process wherein procedures that are typically furnished with a
same day visit are subject to adjustments to account for any resource
costs that the RUC considers to be typically duplicative. Commenters
stated that by applying an MPPR adjustment to these services, CMS was
making an unwarranted second adjustment to account for efficiencies the
RUC already considers to be addressed. A few commenters stated that CMS
provided insufficient rationale for the choice to propose a 50 percent
payment reduction instead of other potential adjustments. Several
commenters also pointed out that there are a number of 0-day global
procedure codes that are valued not to include any evaluation and
management, such as CPT codes 98925-98929 (Osteopathic manipulative
treatment (OMT)). Commenters urged CMS to exempt these codes from the
MPPR adjustment.
Many commenters, including both physician specialty organizations
and patient advocacy groups, expressed concerns about how physicians
would respond to the financial incentives resulting from the
application of an MPPR adjustment in the context of patient care.
Commenters noted that it is often convenient for both the beneficiary
and the practitioner to address multiple concerns in a single visit.
Many commenters stated that there would be a strong financial incentive
to bring patients back for necessary visits on a different day so as to
avoid triggering the payment reduction. This would result in
inconvenience to the beneficiary, as they would experience treatment
delays and be forced to return for a visit. Some commenters suggested
this approach would result in additional cost sharing for patients.
Several commenters also highlighted programmatic concerns, stating
that an MPPR adjustment would incentivize fractured care and undermine
the goals of patient-centered and value-based care. Commenters also
requested that CMS clarify whether certain other visits, such as the
annual wellness visit, would also be subject to the MPPR adjustment.
Others stated that inconsistent guidance, differing policies, and
varying edits among the MACs would result in confusion and
administrative burden in the implementation of this proposal.
A few commenters, including MedPAC, supported the proposal. MedPAC
stated that when a standalone E/M visit occurs on the same day as a
procedure, there are efficiencies (for example, in pre-service and
post-service clinician work and practice expense) that are not
accounted for in the current payment system. MedPAC concluded

[[Page 59640]]

that applying an MPPR to the procedure or visit would account for these
efficiencies. Additional commenters suggested alternative percentages
for the reduction, such as 5 percent or 25 percent. A few commenters
stated that, if the MPPR were to be implemented, services performed by
primary care specialties such as internal medicine, family practice,
geriatrics, and pediatrics should be exempt.
Response: We appreciate commenters' feedback on this aspect of the
proposal, particularly the comments regarding the potentially
troublesome incentives and undesirable consequences associated with the
financial incentives.
We continue to have significant concerns about the appropriate
payment when codes with global periods, especially 0 and 10-day global
periods, are billed on the same day as an E/M visit. Generally, we
understand that the global codes are valued to include the typical
amount of evaluation and management furnished to patients as part of
the service. We understand that when these codes are reported, the -25
modifier is used with an E/M code to report a significant, separately
identifiable E/M visit that is furnished on the same day. We also note
that the CPT descriptor of the -25 modifier includes language
suggesting that the modifier can be used whenever care beyond the usual
preoperative and postoperative care associated with the procedure is
performed. We note further that the values for global codes are
intended to incorporate the typical amount of pre- and post-operative
care. However, given the CPT description of the -25 modifier, a
separately reportable visit could be billed in any case where the pre-
or post-operative care exceeds the typical amount. In contrast, there
does not appear to be a way to similarly account for cases where the
needs of a particular patient require less than the typical amount of
preoperative and postoperative work.
Although many commenters suggested that the overlapping resource
costs between global codes and E/M visits billed on the same day have
already been accounted for, we are not persuaded by the statements that
the RUC process has achieved this goal, and we agree with MedPAC's
assessment of the significant problem with valuation of codes that
describe global services. We acknowledge and appreciate the efforts of
the RUC to address overlaps when they recognize that a code is usually
reported with a same day E/M visit. However, as observers to the RUC
process, we have noted a general tendency for the RUC to recommend only
minor adjustments in physician time and direct PE inputs to account for
overlap. We also often make adjustments to the RUC recommended
valuation in cases where the agency believes there is overlap between
services frequently billed together that has not been adequately
addressed through the RUC process. More importantly, even if the RUC
valuation process better accounted for the overlapping resource costs,
those adjustments would be made to national valuation of particular
codes based on snapshot, national claims data for a given year, and
would apply to all physicians reporting the services regardless of
whether or not these particular physicians were achieving the
efficiencies that occur when visits are reported on the same day as
codes with global periods. Because this dynamic is an inherent part of
valuation based on the typical case for discrete services, we routinely
prioritize review of high-volume services. However, we believe the
application of this methodology in valuing global services is
particularly problematic because there are several thousand codes with
global periods and it is impractical to conduct these kinds of code-
level reviews as frequently as would be necessary to improve the
accuracy of accounting for these efficiencies.
We agree with commenters that if practitioners began deliberately
scheduling visits on separate days, when they could be furnished
together on the same day, in order to avoid the payment adjustment that
could create a significant undue burden for beneficiaries. We have
heard this concern before regarding other MPPRs. We note that we have
major concerns about this kind of manipulation of patient scheduling,
especially as it relates to the fundamental requirement that Medicare
payment may be made only for reasonable and necessary medical care, and
intend to consider this concern more broadly for future rulemaking.
Because we are obligated to develop PFS payments based on the relative
resources involved in furnishing services, we believe the total of
payments to practitioners for physicians' services from both Medicare
and beneficiaries should reflect efficiencies inherent in furnishing
two services that can be furnished together without prompting
manipulative scheduling practices that result in inconvenience and
potential medical risks to Medicare beneficiaries.
After consideration of the public comments, we recognize that we
must balance concerns about appropriate valuation with the potential
disruptions to patient care suggested by commenters. Though we find the
possible practice of scheduling medical services to maximize payment
without regard to patient needs or costs to be highly problematic, we
take these concerns seriously given the broad-based consensus within
the medical and stakeholder community regarding likely behavioral
changes in response to the proposal. After weighing these concerns, we
are not finalizing the proposal to apply an MPPR to a separately
identifiable office/outpatient E/M visit furnished on the same day as a
global procedure. We intend to consider ways to address the practice of
scheduling patients to avoid payment adjustments in future rulemaking.
Given the variety of comments we received regarding the valuation
of specific codes, especially codes with global periods that are
perceived to include no resource costs associated with evaluation and
management, we intend to reconsider the appropriate global period
assigned to certain services. We welcome stakeholder input regarding
appropriate global period assignment through our routine valuation
processes. We will also continue to consider how to address what we
believe to be a significant problem of accurately accounting for
duplicative resource costs in ways that will protect Medicare
beneficiaries' access to appropriate care.
(b) HCPCS G-Code Add-Ons To Recognize Additional Relative Resources for
Certain Kinds of Visits
The distribution of E/M visits is not uniform across medical
specialties. We have found that certain specialists, like neurologists
and endocrinologists, for example, bill higher level E/M codes more
frequently than procedural specialists, such as dermatologists. We
believed this tendency reflects a significant and important distinction
between the kinds of E/M visits furnished by professionals whose
treatment approaches are primarily reported using visit codes versus
those professionals whose treatment approaches are primarily reported
using available procedural or testing codes. However, based on feedback
we received from the medical professionals who furnish primary care and
have visits with greater complexity, we did not believe the current
visit definitions and the associated documentation burdens are the most
accurate descriptions of the variation in work. Instead, we believed
these professionals have been particularly burdened by the
documentation requirements, given that so much of their medical
treatment is

[[Page 59641]]

described imperfectly by relatively generic visit codes.
Similarly, stakeholders such as the commenters responding to the CY
2018 PFS proposed rule have articulated persuasively that visits
furnished for the purpose of primary care also involve distinct
resource costs. In developing this proposal, we consulted a variety of
resources, including the American Academy of Family Physicians (AAFP)
definition of primary care that states that the resource costs
associated with furnishing primary care services particularly include
time spent coordinating patient care, collaborating with other
physicians, and communicating with patients (see https://www.aafp.org/
about/policies/all/primary-care.html). Despite our efforts in recent
years to pay separately for certain aspects of primary care services,
such as through the chronic care management or the transitional care
management services, the currently available coding still does not
adequately reflect the full range of primary care services, nor does it
allow payment to fully capture the resource costs involved in
furnishing a face-to-face primary care E/M visit. We recognized that
primary care services frequently involve substantial non-face-to-face
work, and noted that there is currently coding available to account for
many of those resources, such as chronic care management (CCM),
behavioral health integration (BHI), and prolonged non-face-to-face
services. In light of the existing coding, our proposal only addressed
the additional resources involved in furnishing the face-to-face
portion of a primary care service. As the point of entry for many
patients into the healthcare system, primary care visits frequently
require additional time for communicating with the patient, patient
education, consideration and review of the patient's medical needs. We
believed the proposed value for the single payment rate for the E/M
levels 2 through 5 new and established patient visit codes does not
reflect these additional resources inherent to primary care visits, as
evidenced by the fact that primary care visits are generally reported
using level 4 E/M codes. Therefore, to more accurately account for the
type and intensity of E/M work performed in primary care-focused
visits, we proposed to create a HCPCS add-on G-code that could be
billed with the generic E/M code set to adjust payment to account for
additional costs beyond the typical resources accounted for in the
single payment rate for the levels 2 through 5 visits.
We proposed to create a HCPCS G-code for primary care services,
HCPCS code GPC1X (Visit complexity inherent to evaluation and
management associated with primary medical care services that serve as
the continuing focal point for all needed health care services (Add-on
code, list separately in addition to an established patient evaluation
and management visit)). As we believe a primary care visit is partially
defined by an ongoing relationship with the patient, this code would
describe furnishing a visit to an established patient. HCPCS code GPC1X
could also be reported for other forms of face-to-face care management,
counseling, or treatment of acute or chronic conditions not accounted
for by other coding. We noted that we believed the additional resources
to address inherent complexity in E/M visits associated with primary
care services are associated only with stand-alone E/M visits as
opposed to separately identifiable visits furnished within the global
period of a procedure. Separately identifiable visits furnished within
a global period are identified on the claim using modifier -25, and
would be subject to the MPPR. We noted that we created separate coding
that describes non-face-to-face care management and coordination, such
as CCM and BHI; however, these services describe non-face-to-face care
and can be provided by any specialty as long as they meet the
requirements for those codes. HCPCS code GPC1X was intended to capture
the additional resource costs, beyond those involved in the base E/M
codes, of providing face-to-face primary care services for established
patients. HCPCS code GPC1X would be billed in addition to the E/M visit
for an established patient when the visit includes primary care
services. For HCPCS code GPC1X, we proposed a work RVU of 0.07,
physician time of 1.75 minutes, no direct PE inputs, and an MP RVU of
0.01. This proposed valuation accounted for the additional resource
costs associated with furnishing primary care that distinguishes E/M
primary care visits from other types of E/M visits, and would maintain
work budget neutrality across the office/outpatient E/M code set.
Furthermore, the proposed add-on G-code for primary care-focused E/M
services would help to mitigate potential payment instability that
could result from our adoption of single payment rates that apply for
E/M code levels 2 through 5. As this add-on G-code would account for
the inherent resource costs associated with furnishing primary care E/M
services, we anticipated that it would be billed with every primary
care-focused E/M visit for an established patient. Although we expected
that this code would mostly be utilized by the primary care
specialties, such as family practice or pediatrics, we were also aware
that, in some instances, certain specialists function as primary care
practitioners--for example, an OB/GYN or a cardiologist. Although the
definition of primary care is widely agreed upon by the medical
community and we intended for this G-code to account for the resource
costs of performing those types of visits, regardless of Medicare
enrollment specialty, we also solicited comment on how best to identify
whether or not a primary care visit was furnished, particularly in
cases where a specialist is providing those services. For especially
complex patients, we also expected that this G-code would be billed
alongside the new code we proposed for prolonged E/M services described
later in this section.
We also solicited comment on whether this policy adequately
addresses the deficiencies in CPT coding for E/M services in describing
current medical practice, and concerns about the impact on payment for
primary care and other services under the PFS.
We also proposed to create a HCPCS G-code to be reported with an E/
M service to describe the additional resource costs for specialty
professionals for whom E/M visit codes make up a large percentage of
their overall allowed charges and whose treatment approaches we
believed are generally reported using the level 4 and level 5 E/M visit
codes rather than procedural coding. Due to these factors, the proposed
single payment rate for E/M levels 2 through 5 visit codes would not
necessarily reflect the resource costs of those types of visits.
Therefore, we proposed to create a new HCPCS code GCG0X (Visit
complexity inherent to evaluation and management associated with
endocrinology, rheumatology, hematology/oncology, urology, neurology,
obstetrics/gynecology, allergy/immunology, otolaryngology, cardiology,
or interventional pain management-centered care (Add-on code, list
separately in addition to an evaluation and management visit)). Given
their billing patterns, we believed that these are specialties that
apply predominantly non-procedural approaches to complex conditions
that are intrinsically diffuse to multi-organ or neurologic diseases.
Although some of these specialties are surgical in nature, we believed
these surgical specialties are providing increased non-procedural care
of high complexity in the Medicare population. The high complexity of
these services is reflected

[[Page 59642]]

in the large proportion of level 4 and level 5 visits that we believed
are reported by these specialties, and the extent to which E/M visits
are a high proportion of these specialties' total allowed charges.
Consequently, these are specialties for which the resource costs of the
visits they typically perform are not fully captured in the proposed
single payment rate for the levels 2 through level 5 office/outpatient
visit codes. When billed in conjunction with standalone office/
outpatient E/M visits for new and established patients, the combined
valuation more accurately accounts for the intensity associated with
higher level E/M visits. To establish a value for this add-on service
to be applied with a standalone E/M visit, we proposed a crosswalk to
75 percent of the work and time of CPT code 90785 (Interactive
complexity), which would result in a work RVU of 0.25, no direct PE
inputs, and an MP RVU of 0.01, as well as 8.25 minutes of physician
time based on the CY 2018 valuation for CPT code 90785. Interactive
complexity is an add-on code that may be billed when a psychotherapy or
psychiatric service requires more resources due to the complexity of
the patient. We believed that the proposed valuation for CPT code 90785
would be an accurate representation of the additional work associated
with the higher level complex visits. We noted that we believed the
additional resources to address inherent complexity in E/M visits are
associated with stand-alone E/M visits. Additionally, we acknowledged
that resource costs for primary care are reflected with the proposed
HCPCS code GPC1X, as opposed to the proposed HCPCS code GCG0X. We note
that there are additional codes available that include face-to-face and
non-face-to-face work, depending on the code, that previously would
have been considered part of an E/M visit, such as the codes for CCM,
BHI, and CPT code 99483 (Assessment of and care planning for a patient
with cognitive impairment, requiring an independent historian, in the
office or other outpatient, home or domiciliary or rest home, with all
of the following required elements: Cognition-focused evaluation
including a pertinent history and examination; Medical decision making
of moderate or high complexity; Functional assessment (e.g., basic and
instrumental activities of daily living), including decision-making
capacity; Use of standardized instruments for staging of dementia
(e.g., functional assessment staging test [FAST], clinical dementia
rating [CDR]); Medication reconciliation and review for high-risk
medications; Evaluation for neuropsychiatric and behavioral symptoms,
including depression, including use of standardized screening
instrument(s); Evaluation of safety (e.g., home), including motor
vehicle operation; Identification of caregiver(s), caregiver knowledge,
caregiver needs, social supports, and the willingness of caregiver to
take on caregiving tasks; Development, updating or revision, or review
of an Advance Care Plan; Creation of a written care plan, including
initial plans to address any neuropsychiatric symptoms, neuro-cognitive
symptoms, functional limitations, and referral to community resources
as needed (e.g., rehabilitation services, adult day programs, support
groups) shared with the patient and/or caregiver with initial education
and support. Typically, 50 minutes are spent face-to-face with the
patient and/or family or caregiver), which were developed to reflect
the additional work of those practitioners furnishing primary care
visits. Likewise, we proposed that practitioners in the specialty of
psychiatry would not use either add-on code because psychiatrists may
utilize CPT code 90785 to describe work that might otherwise be
reported with a level 4 or level 5 E/M visit.
Given the broad scope of our proposals related to E/M services, we
solicited feedback on any unintended consequences of those proposals.
We also solicited comment on any other concerns related to primary care
that we might consider for future rulemaking.
Comment: Many commenters stated that CMS needed to clarify the
definition of primary care services that would fall under the scope of
the primary care complexity add-on.
Some commenters suggested that ambiguity around the definition of
the primary care add-on would create additional documentation burden
and concern regarding audit risk. For example, many commenters
presented examples of physicians of many different specialties
furnishing particular services that might be considered to be primary
care, such as when a dermatologist prescribes an anti-hypertensive
medication, and what documentation would be required to justify billing
of the add-on code.
In response to CMS' solicitation for accepted definitions of
primary care, the AAFP stated that primary care services are performed
by practitioners ``specifically trained for and skilled in
comprehensive first contact and continuing care for persons with any
undiagnosed sign, symptom, or health concern.'' The primary care
physician ``provides definitive care to the undifferentiated patient at
the point of first contact and takes continuing responsibility for
providing the patient's comprehensive care.'' Because the definition of
a primary care service hinges on the ongoing relationship with the
patient, the AAFP recommended that the add-on code not be limited to
established patients, but expanded to new patients when the physician
has an expectation that an ongoing relationship will develop.
In response to CMS' request for comment on the circumstances when
it would be appropriate for a specialist to bill for primary care
services, the AAFP stated that while physicians who are not trained in
the core primary care specialties can provide services focused on
``specific patient care needs related to prevention, health
maintenance, acute care, chronic care, or rehabilitation'' but not
within the context of ``comprehensive, first contact, and continuing
care.'' Therefore, the AAFP stated that these practitioners were not
providing primary care.
Response: We are appreciative of the concerns commenters shared
regarding the potential risks of ambiguity in knowing when the code, as
proposed, would be appropriately reported, and how the documentation
would need to justify its appropriateness. The proposal to use an add-
on code to account for the inherent complexity associated with primary
care visits was intended to account for appropriate resource variation
between primary care and other kinds of visits without imposing
additional documentation to justify its being reported for each and
every visit with a beneficiary. We note that this proposal was in
keeping with our longstanding assessment that there are certain
complexities inherent in furnishing some kinds of E/M visits that the
current E/M coding and visit levels do not fully recognize. We also
believe that in almost all cases where physicians and other
professionals are furnishing primary care, information already in the
medical record or on the claim, such as physician specialty, diagnosis
codes, other service codes billed (chronic care or transitional care
management services), or patient relationship codes would serve as
sufficient documentation that the furnished visit met the primary care
description. For example, we would expect that most practitioners
enrolled in such specialties as family medicine, internal medicine,
pediatrics, and geriatrics would be billing the primary care visit
complexity add-on with every office/outpatient E/M visit. The visits
themselves would still need to be

[[Page 59643]]

medically reasonable and necessary in order for the practitioner to
report the service, and the documentation would need to illustrate
medical necessity of the visit, but we believe the appropriateness of
using the primary care add-on to the visit would not necessitate
additional documentation. We also agree with the AAFP that billing this
code should not be limited to established patients, as a primary care
visit may also be a new patient visit where the expectation of an
ongoing relationship is present.
For example, a 68-year-old woman with progressive congestive heart
failure (CHF), diabetes and gout on multiple medications transfers care
to a new primary care clinician. During a visit to establish care, the
clinician discusses the patient's current health issues that includes
confirmation that her CHF symptoms have remained stable over the past 3
months. She also denies symptoms to suggest hyper or hypoglycemia, but
does note pain in her right wrist and knee. Based on the patient's
history, physical exam findings and discussion, the clinician adjusts
the dosage of some of the patient's medications, instructs the patient
to take acetaminophen for her joint pain, request copies of prior
diagnostic studies from his former providers, and orders laboratory
tests to assess glycemic control, metabolic status and kidney function.
The practitioner also discusses age appropriate prevention with the
patient and orders a pneumonia vaccination and screening colonoscopy.
In this case, since the practitioner is furnishing care for
conditions across a spectrum of diagnoses and organ systems and
coordinating the patient's care among multiple health care providers,
the practitioner would report the primary care resource add-on with the
appropriate E/M code. We anticipate that the issues addressed by a
physician will often track with the physician's specialty training.
Therefore, it would not be unexpected for this physician to be
reporting the primary care resource add-on code for almost all E/M
visits, provided they are furnishing primary care during those visits.
We would expect that claims records would include the billing
physician's specialty and that the medical record would include the
diagnoses for the patient, and the clinician's assessment and plan for
that visit. This information would serve as sufficient documentation
that the furnished visit met the primary care complexity description
and so there would be no need to provide additional documentation.
We agree with AAFP that the vast majority of visits billed with the
primary care complexity add-on would be performed by the previously
mentioned specialties; however, we also recognize that there is not
consensus among medical specialties on this definition. We also believe
that there are clinical scenarios when a specialist may perform primary
care. For example:
A cardiologist serving beneficiaries in a rural location provides
care for complex cardiac conditions as well as primary care in her
clinical practice. This practitioner sees a 75-year-old female with
hypertension, coronary artery disease, and osteoarthritis for routine
follow up care. During the visit, the patient describes a worsening
pain in her hip and dizziness for the past month. The clinician notes
gait instability and painful motion of her hip, and significant
orthostasis upon standing. The clinician observes that the patient has
made errors in filling her pill box, and has a new counter anti-
histamine that the patient obtained from her friend to help with sleep.
The clinician conducts a brief cognitive test, ascertains that the
patient had not fallen, and recommends stopping the anti-cholinergic
medication, and adjustment of her blood pressure medications with close
follow-up monitoring. In addition to reviewing the patients' cardiac
status, initiating imaging to evaluate the hip, the clinician also
recommends a home safety evaluation and schedules a follow-up visit to
include her adult daughter who lives nearby. In this case, since the
clinician is furnishing primary care services as well as specialty
cardiology services, the physician would appropriately be reporting the
primary care complexity add-on in addition to the appropriate E/M visit
code. We would expect that the claims record would include the billing
physician's specialty. The medical record would also include the
diagnoses for the patient and clinician's assessment and plan for that
visit.
This information would serve as sufficient documentation that the
furnished visit met the primary care and non-procedural specialty care
complexity adjustment descriptions and so there would be no need to
provide additional documentation.
Comment: Some commenters supported the creation of an add-on code
for primary care visit complexity, but pointed out that, as proposed,
the primary care add-on code was significantly undervalued,
particularly in comparison to the add-on code for visit complexity
associated with specialty care. Commenters were critical of the
approach CMS used to value the proposed primary care add-on code. A few
commenters suggested that CMS should equalize the values between the
two add-on codes.
The AAFP did not support the add-on code, and instead suggested
that CMS provide a 15 percent increase in payment to physicians who
list their primary practice designation as family medicine, internal
medicine, pediatrics, or geriatrics.
Response: The proposed valuation for the primary care complexity
add-on code was based on the application of family budget neutrality to
the proposed changes in other codes and payment policies--most notably
applying an MPPR to E/M office/outpatient visit codes furnished in the
same day as a procedure. While we continue to believe that budget
neutrality within the code family can be an appropriate approach to
assess relative resources under the PFS, we appreciate and agree with
commenters' concerns regarding the asymmetry between the proposed
values for the add-on codes for non-procedural specialty care
complexity and primary care complexity. We also note that we are not
finalizing the proposed multiple procedure payment adjustment for these
E/M office/outpatient visit codes.
Comment: Many commenters did not support separate payment for an
add-on code to account for the resource costs for the inherent
complexity associated with furnishing non-procedural specialty visits.
Commenters assumed that billing the visit complexity add-on code was
limited to the specialties included in the code descriptor,
constituting specialty-specific payment prohibited by statute.
Commenters also stated that CMS was unclear about the rationale for
which specialties were included in the code descriptor, and that the
explanation provided was ambiguous and not clinically derived. Several
commenters expressed concern that CMS did not include the work of a
number of specialties that routinely furnish non-procedural specialist
care and that primarily report that care through the office/outpatient
E/M code set. Many commenters representing these specialties requested
that CMS include them in the code descriptor. These include:
Nephrology, infectious disease, gastroenterology, psychiatry,
ophthalmology, pediatric ophthalmology, orthopedic surgery, sports
medicine, neuro-ophthalmology, hepatology, interventional radiology,
pulmonology, dermatology, medical oncology, Hematopoietic Cell
Transplantation and Cellular Therapy (HCTCT), hospice, and palliative
medicine. Some commenters also noted

[[Page 59644]]

that nurse practitioners are frequently specialized and recommended
that they be eligible to bill for the specialty complexity add-on. A
few commenters stated that Medicare enrollment specialty was a poor
proxy for patient complexity, and that instead, CMS should rely on the
patient's diagnosis. Several commenters did not agree with the proposed
values for the add-on code, but none provided alternatives for CMS to
consider.
Many commenters were also concerned about the documentation
requirements that would be associated with the new coding, stating that
CMS was replacing the burden of documenting the level of E/M visit with
the burden of documenting proper use of the visit complexity add-ons. A
few commenters did support the add-on codes in concept as a useful way
of adjusting payment for different types of visits, although several
commenters pointed out that the add-on codes were not valued
sufficiently to overcome any reduction in payment due to the proposed
single payment rate for visit levels. Commenters requested that CMS
clarify whether the add-on codes could be billed concurrently for the
same visit.
Response: We are appreciative of the concerns commenters shared
regarding the potential risks of ambiguity in knowing when the code, as
proposed, would be appropriately reported, and how the documentation
would need to justify its appropriateness. The proposal to use an add-
on code to account for the inherent complexity associated with non-
procedural specialty care visits was intended to account for
appropriate resource variation between non-procedural specialty care
and other kinds of visits without imposing additional documentation to
justify its being reported for each and every visit with a beneficiary.
We noted that this proposal was in keeping with our longstanding
assessment that there are certain complexities inherent in furnishing
some kinds of E/M visits that the visit levels do not fully recognize.
We also believed that in almost all cases where physicians and other
professionals are furnishing specialty care that is centered around
separately reportable office/outpatient visit codes (as opposed to
procedural codes with global periods, for example), information already
in the medical record or in the claims history for that practitioner,
such as physician specialty, diagnosis codes, and/or other service
codes billed (chemotherapy administration) would serve as sufficient
documentation that the furnished visit met the description of non-
procedural specialty care. For example, we would expect that most
practitioners enrolled in the specialties used as descriptive examples
in the proposed descriptor would report the complexity add-on with
every office/outpatient E/M visit. The visits themselves would still
need to be medically reasonable and necessary in order for the
practitioner to report the service, and the documentation would need to
illustrate medical necessity of the visit, but we believe the
appropriateness of routinely using the add-on to the visit would not
necessitate additional documentation for each and every visit.
A clinical scenario for the use of this proposed add-on code would
be a 72-year-old female with colon cancer who sees her oncologist to
discuss her treatment plan, including surgical and chemotherapeutic
options. Since this E/M visit focuses on oncologic care, the physician
would report the specialty care add-on in addition to the appropriate
E/M visit code. It would not be unexpected for this physician to be
reporting the non-procedural specialty care complexity add-on code for
almost all E/M visits, provided they are providing oncologic care
during those visits. We would expect that the claims record would
include the billing physician's specialty. The medical record would
also include the diagnoses for the patient and clinician's assessment
and plan for that visit. This information would serve as sufficient
documentation that the furnished visit met the description of non-
procedural specialty care complexity and so there would be no need to
provide additional documentation.
We also agree with commenters that the code descriptor omitted
several specialties that provide this type of visit, such as
nephrology, psychiatry, pulmonology, infectious disease, and hospice
and palliative care medicine. We also believe that there are
circumstances where specialties not included in the code descriptor
would appropriately bill this add-on code for inherent visit
complexity. As discussed previously, appropriate reporting of the
specialty care resource add-on code should be apparent based on the
nature of the clinical issues addressed at the E/M visit, and not
limited by the practitioner's specialty.
In cases where appropriate reporting of the add-on code is not as
apparent, we understand that some degree of visit-specific
documentation might be necessary for purposes of demonstrating that the
add-on code was reported appropriately. For example, a physician
enrolled in Medicare as a pathologist may serve a broader role in a
rural community, including furnishing primary care. In this instance,
we expect that there would be documentation in the medical record to
illustrate that it was appropriate for this physician to bill using the
primary care complexity add-on. However, we do not believe that such
scenarios would represent the majority of instances of appropriate use
of the code. Additionally, we note that information usually included in
medical documentation, combined with diagnosis coding, would likely
suffice for purposes of documentation.
After consideration of the comments, we are finalizing for 2021 the
proposal to introduce add-on codes that would adjust payment for new
and established E/M office/outpatient visits to account for inherent
complexity in primary care and non-procedural specialty care. We are
finalizing the code descriptor for the add-on code for inherent
complexity of E/M furnished primary care (HCPCS code GPC1X) as
described in Table 22. We are also finalizing the code descriptor for
the add-on code for inherent complexity of E/M furnished with non-
procedural specialty care (HCPCS code GCG0X) in Table 22, and we note
that we have included refinements to refer to additional kinds of non-
procedural specialty care as suggested by commenters and clarifying
that it could be reported for both new and established patients. We
note that we are not including in the descriptor references to
specialty care that routinely involves significant procedural
interventions, such as interventional radiology and dermatology, since
we do not agree with commenters that these kinds of specialty care are
routinely considered to be ``non-procedural specialist care.'' However,
we note that when clinical circumstances support it, practitioners not
enrolled among the specialties expressly listed within the code
descriptor may bill the inherent visit complexity add-on codes. We are
also finalizing as proposed the code descriptor for inherent complexity
of E/M furnished with primary care (HCPCS code GPC1X) with the
refinement of including that it could be reported for both new and
established patients. The add-on codes to account for inherent
complexity in primary care and non-procedural specialty care could only
be reported with E/M office/outpatient levels 2 through 4 visits. We
note that for this and the other HCPCS G-codes we are finalizing for CY
2021, we are retaining the placeholder HCPCS code numbers until they
are replaced through our standard process.

[[Page 59645]]

Table 22--Finalized Code Descriptors for Visit Complexity Add-Ons
------------------------------------------------------------------------
HCPCS Descriptor
------------------------------------------------------------------------
GPC1X........................ Visit complexity inherent to evaluation
and management associated with primary
medical care services that serve as the
continuing focal point for all needed
health care services (Add-on code, list
separately in addition to level 2
through 4 office/outpatient evaluation
and management visit, new or
established).
GCG0X........................ Visit complexity inherent to evaluation
and management associated with non-
procedural specialty care including
endocrinology, rheumatology, hematology/
oncology, urology, neurology, obstetrics/
gynecology, allergy/immunology,
otolaryngology, interventional pain
management, cardiology, nephrology,
infectious disease, psychiatry, and
pulmonology (Add-on code, list
separately in addition to level 2
through 4 office/outpatient evaluation
and management visit, new or
established).
------------------------------------------------------------------------

We again note that we are finalizing the add-on codes for primary
care and non-procedural specialized care complexity adjustment, as well
as other payment and coding changes to be implemented for E/M office/
outpatient visits for CY 2021. We are specifying the later date, in
great part, so that we have an opportunity to fully consider public
comments and other important input from stakeholders on potential
refinements in code and service definitions that can be used with ease,
when appropriate, and by practitioners whom we currently believe are
disproportionately burdened under the current coding and documentation
requirements and, more generally, other important information involving
coding and payment for E/M services.
After considering the public comments, we agree that the complexity
associated with furnishing a primary care visit is equivalent to that
associated with furnishing a non-procedural specialty care visit, and
therefore, the two codes should be valued equally. We are finalizing,
for 2021, the input values for these two codes as reflected in Table
23.
We note that these inputs reflect our proposed valuation of the
non-procedural specialty complexity code, based on a modified crosswalk
from CPT code 90785 as discussed in the CY 2019 PFS proposed rule (83
FR 35842).

Table 23--Inputs for HCPCS Codes GCG0X and GPC1X Finalized for 2021
------------------------------------------------------------------------
Physician
HCPCS time Work RVU MP RVU
------------------------------------------------------------------------
GCG0X............................ 8.25 0.25 0.02
GPC1X............................ 8.25 0.25 0.02
------------------------------------------------------------------------

We also note that, while our policy will result in our inclusion of
these input values in developing proposed rates for CY 2021, we also
recognize that we routinely accept recommendations from the RUC and
other stakeholders regarding appropriate valuation for PFS services,
and would consider such recommendations regarding appropriate valuation
for these services under our usual, annual process for receiving
recommendations for PFS services.
In response to the commenters' concerns regarding the interactions
between this code and the other codes that describe more complex E/M
visits, we are clarifying that these add-on codes are intended to serve
as a corollary to the single payment rate for E/M office/outpatient
visit codes defined as levels 2 through 4 to provide for more
appropriate recognition of the variations in resources involved in
furnishing those services, and not to be used in association with E/M
office/outpatient level 1 or level 5 visits.
While we believe that in most cases practitioners would only be
reporting either the primary care complexity code or non-procedural
specialty care complexity code, we believe there are some very rare
circumstances where use of both codes might be appropriate. We return
to our example of the cardiologist serving beneficiaries in a rural
location who provides care for complex cardiac conditions as well as
primary care in her clinical practice. Since the needs of the community
prompt this physician to provide primary care services as well as
specialty cardiology services, we would expect that she would report
the primary care complexity add-on code and non-procedural specialty
care complexity add-on code in addition to the appropriate E/M visit
code when both primary care and non-procedural specialty care are
furnished in connection with E/M visits.
(c) HCPCS G-Coded To Describe Podiatric E/M Visits
As described earlier, the vast majority of podiatric visits are
reported using lower level E/M codes, with most E/M visits billed at a
level 2 or 3, reflecting the type of work done by podiatrists as part
of an E/M visit. Therefore, while the proposed consolidation of
documentation and payment for E/M code levels 2 through 5 was intended
to better reflect the universal elements of E/M visits across
specialties and patients, we believed that podiatric E/M visits were
not accurately represented by the consolidated E/M structure. In order
for payment to reflect the resource costs of podiatric visits, we
proposed to create two HCPCS G codes, HCPCS codes GPD0X (Podiatry
services, medical examination and evaluation with initiation of
diagnostic and treatment program, new patient) and GPD1X (Podiatry
services, medical examination and evaluation with initiation of
diagnostic and treatment program, established patient), to describe
podiatric E/M services. Under this proposal, podiatric E/M services
would be billed using these G-codes instead of the generic office/
outpatient E/M visit codes (CPT codes 99201 through 99205 and 99211
through 99215). We proposed to create these separate G-codes for
podiatric E/M services to differentiate the resources associated with
podiatric E/M visits rather than propose a negative add-on adjustment
relative to the proposed single payment rates for the generic E/M
levels 2 through 5 codes. Therefore, we proposed to create separate
coding to describe these services, taking into account that most
podiatric visits are billed as level 2 or 3 E/M codes. We based the
coding structure and code descriptor on CPT codes 92004
(Ophthalmological services: Medical examination and evaluation with
initiation of diagnostic and treatment program; comprehensive, new
patient, 1 or more visits) and 92012

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(Ophthalmological services: Medical examination and evaluation, with
initiation or continuation of diagnostic and treatment program;
intermediate, established patient), which describe visits specific to
ophthalmology. To accurately reflect payment for the resource costs
associated with podiatric E/M visits, we proposed a work RVU of 1.35, a
physician time of 28.11 minutes, and direct PE inputs totaling $22.53
for HCPCS code GPD0X, and a work RVU of 0.85, physician time of 21.60
minutes, and direct PE inputs totaling $17.07 for HCPCS code GPD1X.
These values were based on the average rate for the level 2 and 3 E/M
codes (CPT codes 99201-99203 and CPT codes 99211-99212, respectively),
weighted by podiatric volume.
Comment: Commenters opposed making separate payment for podiatric
E/M visits using distinct coding. Commenters stated that, by creating
separate coding and payment to describe these types of visits, CMS was
singling out podiatrists and devaluing podiatric physicians' status
among their peer physicians. Some commenters questioned the legality of
our proposal since it would effectively pay physicians of different
specialties different amounts for services that CPT considers to be the
same. Furthermore, commenters stated that the proposed rates for
podiatric E/M visits did not reflect the resource costs associated with
providing podiatric care. Commenters also objected to the use of the
ophthalmology visit codes as a precedent, stating that the significant
practice expense associated with ophthalmologic visits was the impetus
for separate coding for those services.
Response: Based on our consideration of the information presented
by commenters, we are persuaded that there could be a perceived
devaluation of the breadth and value of care associated with podiatric
visits by use of separate coding for these visits. Given these
potential negative consequences, we are not finalizing the proposal to
adopt separate coding for podiatric E/M visits. However, as our
discussion in the preceding sections reflects, we do not agree with the
commenters that all office/outpatient visits furnished by physicians
are only distinguishable by visit levels under the current CPT
definitions. Instead, we believe that, like procedural services, visit
services and their associated relative resource costs can vary greatly
by the kind of care that is provided by particular physicians. We also
believe that physician specialties can often reflect different
approaches to medical care, and that the nomenclature used to describe
and define various clinical specialties is useful for purposes of
distinguishing among the types of services, including visits, furnished
by physicians using these different approaches.
We also acknowledge that our proposal should have clearly
articulated that we were not proposing to prohibit podiatrists from
reporting the E/M office/outpatient visit codes under circumstances
where those codes more accurately described visits with particular
patients or, more broadly, visits generally furnished by particular
podiatrists.
We also would like to note that our analysis of claims data
indicates that the vast majority of podiatric visits are reported as
level 2 and 3 visits. We believe that these claims data are an
important piece of evidence regarding the relative resource costs of
office/outpatient visits that are podiatric in nature. Therefore, we do
not agree with the commenters that stated that our proposal did not
reflect resource-based valuation, since we consider Medicare claims
data to be one of the best sources of data regarding the resources
involved in furnishing PFS services.
After considering the comments regarding this proposal, we are not
finalizing our proposal to create separate coding for podiatric E/M
services and establish payment rates for podiatric E/M visits based on
historical billing patterns. We acknowledge the commenters' concerns
that creating specific coding as we proposed could suggest a
devaluation of services furnished by podiatrists. Therefore, we are not
finalizing creation of specific coding and payment values for podiatric
E/M visits. For CY 2021, podiatric E/M visits would be reported and
paid using the E/M coding and payment structure applicable to other E/M
office/outpatient visits.
(d) Adjustment to the PE/HR Calculation
As we explain in section II.B. of this final rule, Determination of
Practice Expense (PE) Relative Value Units (RVUs), we generally
allocate indirect costs for each code on the basis of the direct costs
specifically associated with a code and the greater of either the
clinical labor costs or the work RVUs. Indirect expenses include
administrative labor, office expense, and all other PEs that are not
directly attributable to a particular service for a particular patient.
Generally, the proportion of indirect PE allocated to a service is
determined by calculating a PE/HR based upon the mix of specialties
that bill for a service.
As described earlier, E/M visits comprise a significant portion of
allowable charges under the PFS and are used broadly across specialties
such that our proposed changes can greatly impact the change in payment
at the specialty level and at the practitioner level. Our proposals
sought to simplify payment for E/M visit levels 2 through 5, and to
additionally take into consideration that there are inherent
differences in primary care-focused E/M services and in more complex E/
M services such that those visits involve greater relative resources,
while seeking to maintain overall payment stability across specialties.
However, establishing a single PFS rate for new and established patient
E/M levels 2 through 5 would have a large and unintended effect on many
specialties due to the way that indirect PE is allocated based on the
mixture of specialties that furnish a service. The single payment rates
proposed for E/M levels 2 through 5 could not reflect the indirect PE
previously allocated differentially across those 8 codes. Historically,
a broad blend of specialties and associated PE/HR has been used in the
allocation of indirect PE and MP RVUs to E/M services to determine
payment rates for these services. As this proposal would have
significantly altered the PE/HR allocation for the office/outpatient E/
M codes and any previous opportunities for the public to comment on the
data would not have applied to these kinds of E/M services, we did not
believe it was in the public interest to allow the allocation of
indirect PE to have such an outsized impact on the payment rates for
this proposal. Due to the magnitude of the proposed coding and payment
changes for E/M visits, it was unclear how the distribution of
specialties across E/M services would change. We were concerned that
such changes could produce anomalous results for indirect PE
allocations since we did not yet know the extent to which specialties
would utilize the proposed simplified E/M codes and proposed G-codes.
In the past, when utilization data are not available or do not
accurately reflect the expected specialty mix of a new service, we have
proposed to crosswalk the PE/HR value from another specialty (76 FR
73036). As such, we proposed to create a single PE/HR value for E/M
visits (including all of the proposed HCPCS G-codes discussed above) of
approximately $136, based on an average of the PE/HR across all
specialties that bill these E/M codes, weighted by the volume of those
specialties' allowed E/M services. We believed that this was consistent
with

[[Page 59647]]

the methodology used to develop the inputs for the proposed simplified
E/M payment for the levels 2 through 5 E/M visit codes, and that, for
purposes of consistency, the new PE/HR should be applied across the
additional E/M codes. We believed a new PE/HR value would more
accurately reflect the mix of specialties billing both the generic E/M
code set and the add-on codes. If we finalized this proposal, we would
have considered revisiting the PE/HR after several years of claims data
become available.
The following is a summary of the comments we received on this
proposal.
Comment: Many commenters noted that the application of a single PE/
HR value to E/M visit codes had significant, if unintended,
consequences for the allocation of indirect PE across the PFS.
Commenters also stated that CMS did not provide enough information as
to how we arrived at the PE/HR value, which resulted in difficulty
among external stakeholders in modeling the proposal.
Response: We appreciate commenters highlighting the broad
ramifications of this proposal.
After consideration of these comments, we will not be finalizing a
separate PE/HR for office/outpatient E/M visits.
(e) HCPCS G-Code for Extended Visit Services
Time is often an important determining factor in the level of care,
which we consider in our proposal described earlier that physicians and
other practitioners can use time as the basis for documenting and
billing the appropriate level of E/M visit for purposes of Medicare
payment. Currently there is inadequate coding to describe services
where the primary resource of a service is physician time. CPT codes
99354 (Prolonged evaluation and management or psychotherapy service(s)
(beyond the typical service time of the primary procedure) in the
office or other outpatient setting requiring direct patient contact
beyond the usual service; first hour (List separately in addition to
code for office or other outpatient Evaluation and Management or
psychotherapy service)) and 99355 (Prolonged evaluation and management
or psychotherapy service(s) (beyond the typical service time of the
primary procedure) in the office or other outpatient setting requiring
direct patient contact beyond the usual service; each additional 30
minutes (List separately in addition to code for prolonged service))
describe additional time spent face-to-face with a patient and may be
billed when the applicable amount of time exceeds the typical service
time of the primary procedure.
Stakeholders have informed CMS that the ``first hour'' time
threshold in the descriptor for CPT code 99354 is difficult to meet and
is an impediment to billing these codes (81 FR 80228). In response to
stakeholder feedback and as part of our proposal to implement a single
payment rate for E/M visit levels 2 through 5 while maintaining payment
accuracy across the specialties, we proposed to create a new HCPCS code
GPRO1 (Prolonged evaluation and management or psychotherapy service(s)
(beyond the typical service time of the primary procedure) in the
office or other outpatient setting requiring direct patient contact
beyond the usual service; 30 minutes (List separately in addition to
code for office or other outpatient Evaluation and Management or
psychotherapy service)). Given that the physician time of HCPCS code
GPRO1 is half of the physician time assigned to CPT code 99354, we
proposed a work RVU of 1.17, which is half the work RVU of CPT code
99354.
Comment: Many commenters, including the AMA, were supportive of the
creation of this code in isolation from the rest of the E/M coding and
payment proposals. Other commenters stated that the code was
unnecessary, that current coding was sufficient to account for
additional time spent with patients, and that it was unrealistic to
expect that most physicians would be able to meet the time threshold in
enough volume to offset the negative impacts of the single payment rate
for E/M office/outpatient new and established patient visit levels 2
through 5. Some commenters suggested more documentation would be
necessary to bill this new code. Many commenters also stated that
referring to this code as ``prolonged services'' was inconsistent with
coding conventions and CPT definitions, as the CPT Editorial Panel
defined prolonged services as an unusual amount of time spent beyond
the typical time and these commenters understood from the proposal that
the code was intended to be reported more frequently. Many commenters
stated that it would be difficult to assess how the code might be used
without more specific guidelines regarding how time would be counted,
particularly with regard to how many minutes would be assumed to be
associated with the companion visit code and whether or not we adopt
the usual CPT coding convention for appropriate reporting of the time-
based code when over half the number of minutes (16 in this case) have
been spent. Several commenters suggested that 16 minutes beyond the
time associated with the proposed single payment rate (31 minutes as
described by many of these commenters) would mean that the code could
only be reported after 47 minutes spent with an established patient.
These commenters suggested that that threshold would likely result in
the code being used rarely.
Response: We agree with commenters that current coding describing
prolonged services is not sufficient to capture additional time spent
with patients, especially in the context of creating a single payment
rate for office/outpatient E/M levels 2 through 4. We believe that time
is a critical resource cost for physicians and other practitioners, and
the time spent with patients is a great benefit to Medicare
beneficiaries. We also note that we are required by statute to consider
time, along with intensity, in establishing the work relative value
units that determine PFS payments. We are therefore finalizing for 2021
separate payment for HCPCS code GPRO1, and are finalizing the input
values as proposed.
We appreciate commenters' concerns regarding the current
definitions and use of ``prolonged'' as applying to unusually long
visits. We believe that time spent with patients ought to vary based on
the particular needs of the patient and that variations in time spent
face-to-face with the patient can be critical in defining differences
between the services being furnished. Consequently, we agree that for
many practitioners, times that extend beyond what we, or the CPT
Editorial Panel, consider to be typical under the current visit code
descriptors and definitions, might, in actual practice, be routine. We
also note that many services, such as psychotherapy, are currently
defined and paid based on the duration of the service.
However, since commenters have suggested that the term
``prolonged'' has been established in coding convention as applying
only to unusually long visits as opposed to use in describing routine
variations in the amount of time spent during visits with patients, we
believe using an alternative term, like ``extended visit'' may serve to
underscore our expectation that the length of some visits might exceed
the typical length, but would not be unusual for certain practices or
patients.
We also note that, for audit purposes, we would expect the medical
record to reflect that the billing practitioner actually spent the
amount of time with the patient described by the code and that the
visit itself, in its entirety, was medically necessary; but we would
not

[[Page 59648]]

expect additional documentation to demonstrate that the difference in
time between the visit code and the extended visit code was, in
isolation of the visit, medically necessary.
For CY 2021, we are finalizing a coding and payment policy to
account for the additional resources required when practitioners need
to spend extended time with their patients during particular E/M
office/outpatient level 2 through 4 visits, regardless of the kind of
care the practitioner is furnishing or whether or not the medical
complexity of the visit is the determining factor for the length of
visit. After considering the comments, we believe that 30 additional
minutes (which, in accordance with CPT coding conventions for timed
codes, can be reported after 15 additional minutes is spent with the
patient) is an appropriate interval of time after which to reflect the
additional resource costs associated with patient visits that require
more time than is typical for the visit. After considering the
questions and concerns expressed by commenters about how the new add-on
code would be used, and in particular, the number of minutes that would
serve as the basis for counting time toward an extended visit (for
example, whether we would look to the typical time for the companion E/
M code level and use the CPT coding convention for time-based codes),
we acknowledge that it would not be workable to use the same
conventions as are used for the prolonged service codes.
Under the current conventions used in reporting the existing
prolonged service codes, the prolonged codes are defined by a set
number of additional minutes beyond time associated with individual
companion visit codes. For example, the initial prolonged services code
describes 60 minutes of prolonged time beyond the time associated with
the individual companion visit code. The current level 5 existing
patient code is described by CPT as typically requiring 40 minutes with
the patient, so that when reporting 99215 with the prolonged service
code, the time being described is a total of 100 minutes (40 minutes
for the level 5 code and 60 minutes for the initial prolonged code).
Under applicable coding conventions, the code is reportable, when at
least half the number of described minutes for the prolonged code is
spent. This means that the initial prolonged service code can be
reported with a level 5 existing patient code after 70 minutes (40
minutes for the full time associated with the level 5 visit and 30
minutes for half the number of minutes described by the initial
prolonged service code).
We recognize that to implement use of either new or even the
existing prolonged services code in the context of using a single
payment rate for codes of varying levels, we would need to be clear
about what time should be used for the companion visit codes.
Currently, practitioners rely on the CPT ``typical'' times to determine
the time for the visit codes of varying levels. This means that the
thresholds for visit time required before the prolonged services can be
reported are higher when higher level visits are reported in comparison
to lower level visits. Under current payment rates, this situation is
offset to some degree by the higher overall payment in circumstances
where the higher level visit code is reported.
Because we are finalizing a single payment rate for levels 2-4,
however, use of the ``typical'' CPT times as the basis for reporting
add-on codes that describe additional time would mean that lower level
visits that take more time would be paid at higher rates than higher
visit rates that take the same amount of time. We believe that because
we are paying a single rate for these services (as each of the codes
describe a single ``typical'' for purposes of payment), we should also
use a single number of minutes for purposes of reporting time-based
add-on codes: The weighted average of the ``typical'' times associated
with each of the codes that comprise the single payment rate.
One approach to implementing this would be to revise our billing
rules to instruct practitioners to use the weighted average of the
``typical'' times associated with each of the codes that comprise the
single payment rate, instead of the ``typical'' CPT times associated
with the individual billed codes. We could apply this definition
broadly to specify use of the weighted average typical times for level
2-4 codes regardless of whether or not they are being reported with
time-based add-on codes, but we do not want to prevent practitioners
from appropriately reporting visits based on the time defined as
typical under the CPT code descriptors for office/outpatient E/M
visits, especially since we are adopting a policy to allow clinicians
to use time as the basis for documentation and code selection.
Alternatively, we could require practitioners to use the weighted
average of the ``typical'' times associated with each of the codes that
comprise the single payment rate only in cases where time-based add-on
codes are also being reported. However, we believe using two separate
rules, especially one that deviates from the typical times established
for the different visit levels that will continue to be routinely
reported by a wide range of practitioners, would be likely to cause
confusion.
After consideration of these issues and considering the
alternatives, we are finalizing a code descriptor for the extended
visit code that describes a single range of minutes that applies to the
overall duration of face-to-face time during the visit, without regard
to which level 2, 3, or 4 E/M office/outpatient visit was reported.
This range is 34 to 69 minutes, so that the add-on code for extended
visits would be appropriately reported in any case where a medically
necessary E/M office/outpatient visit, reported using levels 2 through
4, required between 34 and 69 minutes (for established patients) and
between 38 and 89 minutes (for new patients) of face-to-face time with
the billing practitioner. We calculated the lower end of the range by
summing the weighted average of intraservice times for the component
codes that make up the single payment rate for level 2 through 4 visits
(23 minutes for new and 19 minutes for established) and the additional
amount of time required to bill the proposed add-on code (15 minutes
under coding convention for prolonged services). The upper range of the
use of the extended visit code is 69 minutes for established patients
and 89 minutes for new patients.
We note that to report the current prolonged codes or the new
extended services code, practitioners need to note that the requisite
number of minutes were spent with the patient. We also note that we are
finalizing the policy to allow practitioners the choice to use time as
the basis for code selection for level 2 through 5 all office/
outpatient E/M codes beginning in 2021 regardless of whether or not
counseling and/or coordination of care accounts for more than 50
percent of the face-to-face physician/patient encounter. Under the new
policy, then, any visits that exceed the length of the time ranges of
the level 2 through 4 visit codes plus the extended visit code, could
be reported using the level 5 visit code and the existing prolonged
services code. Table 24A illustrates these rules:

[[Page 59649]]

Table 24A--Minutes Spent on Extended Outpatient Visits
[Established and new patients]
----------------------------------------------------------------------------------------------------------------
Established patient New patient
----------------------------------------------------------------------------------------------------------------
Level Minutes spent Codes reported Level Minutes spent Codes reported
----------------------------------------------------------------------------------------------------------------
1................ N/A 1................ N/A
-------------------------------------- -------------------------------------
2................ 34-69 99212/3/4+extended 2................ 38-89 99203/4/5+extended
services G-code. services G-code.
3................ 3................
4................ 4................
-------------------------------------- -------------------------------------
5................ 70+ 99215+99354......... 5................ 90+ 99205+99354.
----------------------------------------------------------------------------------------------------------------

The new extended services code will be described as GPRO1 (Extended
time for evaluation and management service(s) in the office or other
outpatient setting, when the visit requires direct patient contact of
34-69 total face-to-face minutes overall for an existing patient or 38-
89 minutes for a new patient (List separately in addition to code for
level 2 through 4 office or other outpatient Evaluation and Management
service)). We again note that we are finalizing payment and coding
changes to be implemented for E/M office/outpatient visits for CY 2021.
We will consider any changes that are made to CPT coding, including for
prolonged services, and recommendations regarding appropriate valuation
of new or revised codes, through our annual rulemaking process.
In order to estimate the potential impact of the proposed changes
in the proposed rule, we modeled the results of several options and
examined the estimated resulting impacts in overall Medicare allowed
charges by physician specialty. Because we are not finalizing many of
the changes for CY 2019 as proposed, we believe the inclusion of those
same discussions in this final rule is unnecessary and could
potentially be confusing. We point readers to the CY 2019 PFS proposed
rule, (83 FR 35844 through 35847) for discussion of the analyses
relevant to the proposals. For analysis regarding the potential impacts
of the alternatives considered in development of this final rule, we
direct readers to the section VII. of this final rule, Regulatory
Impact Analysis, in addition to the discussion that follows.
To compare the overall payment impact for the changes in payment
for visit services between the current policy as of 2018 and the
policies we are finalizing starting in 2021, we provide a narrative
example in the paragraph below and Table 24B. In CY 2018, a physician
would bill a level 4 E/M visit and document using the existing
documentation framework for a level 4 E/M visit. The payment rate would
be approximately $109 in the office setting. In CY 2021, the physician
would bill the same visit code for a level 4 E/M visit, with the option
to document the visit according to the minimum documentation
requirements for a level 2 E/M visit if they choose to document based
on MDM, or the 1995 or 1997 guidelines, or to document on the basis of
time. The physician might also bill either of the proposed add-on codes
(HCPCS codes GPC1X or GCG0X) depending on the type of patient care
furnished, and could bill the extended services code if she met the
time threshold for this code. The combined payment rate for the E/M
visit code, plus the extended services code, and either HCPCS code
GPC1X or GCG0X would be approximately $170.
[GRAPHIC] [TIFF OMITTED] TR23NO18.039

[[Page 59650]]

(f) Alternatives Considered
We considered a number of other options for simplifying coding and
payment for E/M services to align with the proposed reduction in
documentation requirements and to better account for the resources
associated with inherent complexity, visit complexity, and visits
furnished on the same day as a 0-day global procedure. As we are
finalizing a policy very similar to one of the alternatives we
considered for the proposed rule, we believe it would be confusing to
include a detailed discussion of that policy as an alternative
considered. We therefore direct interested readers to the CY 2019 PFS
proposed rule (83 FR 35847).
Section 101(f) of the MACRA added a new subsection (r) under
section 1848 of the Act entitled Collaborating with the Physician,
Practitioner, and Other Stakeholder Communities to Improve Resource Use
Measurement. Section 1848(r) of the Act requires the establishment and
use of classification code sets: Care episode and patient condition
groups and codes; and patient relationship categories and codes. As
described in the CY 2018 PFS final rule, we finalized use of Level II
HCPCS Modifiers as the patient relationship codes and finalized that
Medicare claims submitted for items and services furnished by a
physician or applicable practitioner on or after January 1, 2018,
should include the applicable patient relationship codes, as well as
the NPI of the ordering physician or applicable practitioner (if
different from the billing physician or applicable practitioner). We
noted that for CY 2018, reporting of the patient relationship modifiers
would be voluntary and the use and selection of the modifiers would not
be a condition of payment (82 FR 53234). The patient relationship codes
are as follows: X1: Continuous/broad; X2: Continuous/focused; X3:
Episodic/focused; X4: Episodic/broad; and X5: Only as ordered by
another physician. These codes are to be used to help define and
distinguish the relationship and responsibility of a clinician with a
patient at the time of furnishing an item or service, facilitate the
attribution of patients and episodes to one or more clinicians, and to
allow clinicians to self-identify their patient relationships.
We considered proposing the use of the care episode and patient
relationship codes to adjust payment for E/M visits to the extent that
these codes are indicative of differentiated resources provided in E/M
visits, and we considered using these codes as an alternative to the
proposed use of G-codes to reflect visit complexity inherent to
evaluation and management in primary care and certain other specialist
services, as a way to more accurately reflect the resource costs
associated with furnishing different kinds of E/M visits. We solicited
comment on this alternative. We were particularly interested in whether
the modifiers would accurately reflect the differences between
resources for E/M visits across specialties and would therefore be
useful to adjust payment differentially for the different types of E/M
visits that we previously identified. The following is a summary of the
comments we received on these items.
Comment: AAFP urged CMS not to use the patient relationship codes
for the purposes of making differential payment, stating that these
modifiers were never intended to adjust payment or reflect visit
complexity, only to denote the relationship of the beneficiary and
practitioner at any given encounter. One commenter stated that using
patient relationship codes to adjust payment was an intriguing idea
that should be researched further.
Response: We thank commenters for their input and will consider
whether to adopt these codes for use to adjust payment at a later date
through notice and comment rulemaking. We note, however, that we
believe the use of the continuous care patient relationship codes
stands as a good example of evidence in the claims record to support
use of the primary care inherent complexity add-on code, as discussed
previously.
In Table 24C, we estimate the specialty level impacts of the E/M
payment and coding policies we are finalizing for 2021, calculated as
if they were implemented for CY 2019.

Table 24C--Estimated Specialty Level Impacts of Final E/M Payment and Coding Policies if Implemented for 2019
----------------------------------------------------------------------------------------------------------------
(A) (B) (C) (D) (E) (F)
Specialty Allowed Impact of work Impact of PE Impact of MP Combined
charges RVU changes RVU changes RVU changes impact
(mil) (%) (%) (%) (%)
----------------------------------------------------------------------------------------------------------------
Allergy/Immunology.............. $239 0 0 0 0
Anesthesiology.................. 1,981 -1 0 0 -2
Audiologist..................... 68 -1 1 0 0
Cardiac Surgery................. 294 -1 -1 0 -2
Cardiology...................... 6,618 -1 -1 0 -2
Chiropractor.................... 754 -1 0 0 -1
Clinical Psychologist........... 776 -1 1 0 0
Clinical Social Worker.......... 728 -2 2 0 0
Colon And Rectal Surgery........ 166 0 1 0 0
Critical Care................... 342 -2 -1 0 -3
Dermatology..................... 3,486 1 3 0 4
Diagnostic Testing Facility..... 733 0 -5 0 -5
Emergency Medicine.............. 3,121 -2 -1 0 -2
Endocrinology................... 482 -1 -1 0 -2
Family Practice................. 6,208 1 1 0 2
Gastroenterology................ 1,757 -2 -1 0 -3
General Practice................ 429 2 1 0 3
General Surgery................. 2,093 0 0 0 -1
Geriatrics...................... 197 -1 -1 0 -1
Hand Surgery.................... 214 1 1 0 3
Hematology/Oncology............. 1,741 0 -1 0 0
Independent Laboratory.......... 646 -1 3 0 3
Infectious Disease.............. 649 -1 -1 0 -1
Internal Medicine............... 10,767 0 0 0 0

[[Page 59651]]

Interventional Pain Mgmt........ 868 1 2 0 3
Interventional Radiology........ 386 0 -2 0 -2
Multispecialty Clinic/Other Phys 149 -1 -1 0 -2
Nephrology...................... 2,190 -1 -1 0 -2
Neurology....................... 1,529 -1 0 0 -1
Neurosurgery.................... 804 -1 -1 0 -1
Nuclear Medicine................ 50 -1 -1 0 -3
Nurse Anes/Anes Asst............ 1,242 -2 0 0 -2
Nurse Practitioner.............. 4,065 2 1 0 3
Obstetrics/Gynecology........... 638 2 2 0 5
Ophthalmology................... 5,448 -1 -2 0 -3
Optometry....................... 1,309 0 -1 0 -1
Oral/Maxillofacial Surgery...... 68 0 0 0 1
Orthopedic Surgery.............. 3,743 0 1 0 1
Other........................... 31 -1 3 0 2
Otolarngology................... 1,210 3 3 0 5
Pathology....................... 1,165 -1 -1 0 -2
Pediatrics...................... 61 1 0 0 1
Physical Medicine............... 1,107 -1 0 0 -2
Physical/Occupational Therapy... 3,950 -1 -2 0 -3
Physician Assistant............. 2,457 2 1 0 4
Plastic Surgery................. 377 0 0 0 1
Podiatry........................ 1,974 4 6 0 10
Portable X-Ray Supplier......... 99 0 0 0 0
Psychiatry...................... 1,187 3 2 0 5
Pulmonary Disease............... 1,715 -1 -1 0 -2
Radiation Oncology And Radiation 1,766 -1 -1 0 -1
Therapy Centers................
Radiology....................... 4,911 -1 -1 0 -2
Rheumatology.................... 541 0 -1 0 -1
Thoracic Surgery................ 358 -1 -1 0 -2
Urology......................... 1,738 2 3 0 4
Vascular Surgery................ 1,148 0 -2 0 -2
-------------------------------------------------------------------------------
Total....................... 92,771 0 0 0 0
----------------------------------------------------------------------------------------------------------------

Table 24C illustrates the estimated specialty level impacts
associated with implementing our finalized policies for E/M coding and
payment in CY 2019, rather than delaying until CY 2021. Table 24C shows
the estimated impacts of adopting single payment rates for new and
established patient E/M office/outpatient visit levels 2 through 4
(with the rates determined using input values that reflect the 5 year
weighted average of current inputs for codes describing those visit
levels), keeping separate rates for new and established patient E/M
visit level 5 (with the rates determined using the current input values
for level 5 visits), and adopting add-on codes with equal rates to
adjust for the inherent visit complexity of primary care and non-
procedural specialty care (with the rates determined using the input
values from the proposed rule for the non-procedural specialty care
complexity code). Under our finalized policies, specialties who
disproportionately report lower level visits, such as podiatry, and
specialties that report office/outpatient visits in conjunction with
minor procedures, such as dermatology, would see the significant
increases. Specialties that predominantly furnish higher level visits
would have their payment decreases significantly mitigated by the
maintenance of the level 5 visit and the add-on codes for inherent
visit complexity for primary and non-procedural specialty care.
Specialties that do not furnish office/outpatient visits generally
would see modest reductions in overall payment.
We note that because our original proposal was developed more
generally to maintain overall RVUs within the range of codes describing
office/outpatient E/M visits, but, in response to public comment, we
are not finalizing several elements of those proposals including, and
especially, the multiple procedure payment reduction relating to global
services billed with same day E/M services, the overall number of RVUs
allocated to office/outpatient services would be increased relative to
other PFS services. Under our established methodology and consistent
with the governing statute, we usually apply a budget neutrality
adjustment in the PFS conversion factor to account for the changes in
overall RVUs. This adjustment would apply to all PFS services, and we
are not finalizing any deviation from that approach for 2021. However,
we also note that in some cases, we have proposed and finalized inputs
for particular services that are designed to maintain the overall RVUs
for those services despite changes in coding. For more detailed
information on this approach to addressing valuation for families of
services, we direct readers to the CY 2012 PFS final rule with comment
period (76 FR 73105). We also note that while it has been our standard
practice to avoid scaling the full set of work RVUs to maintain budget
neutrality, we could also consider that alternative given the
significance of office/outpatient visit codes in PFS relativity. Were
we to consider either of these alternative

[[Page 59652]]

approaches for 2021, we would address them through future rulemaking.
g. Emergency Department and Other E/M Visit Settings
As we mentioned above, the E/M visit code set is comprised of
individual subsets of codes that are specific to various clinical
settings including office/outpatient, observation, hospital inpatient,
emergency department, critical care, nursing facility, domiciliary or
rest home, and home services. Some of these code subsets have three E/M
levels of care, while others have five. Some of these E/M code subsets
distinguish among levels based heavily on time, while others do not.
Recent public comments have noted that some E/M code subsets intersect
more heavily than others with hospital conditions of participation
(CoP). For example, the American Psychiatric Association (APA)
submitted a letter to CMS indicating that Medicare requires specific
documentation in the medical record as part of the CoPs for inpatient
psychiatric facilities. The APA believed that the required initial
psychiatric evaluation for inpatients currently closely follows the E/M
criteria for CPT codes 99221-99223, which are the codes that would be
used to bill for these services. The APA stated that any changes in
these E/M codes, without corresponding changes in the CoPs, could lead
to the unintended consequence of adding to the burden of documentation
by essentially requiring two different sets of data or areas of focus
to be included, or two different documentation formats being required.
Regarding emergency department visits (CPT codes 99281-99285), we
received more recent feedback through our coordinated efforts with ONC
this year, emphasizing that these codes may benefit from a coding or
payment compression into fewer levels of codes, or that documentation
rules may need to be reduced or altered. However, in public comments to
the CY 2018 PFS proposed rule, commenters noted several issues unique
to the emergency department setting that we believe require further
consideration. For example, commenters stated that intensity, and not
time, is the main determinant of code level in emergency departments.
They requested that CMS use caution in changing required elements for
documentation so that medical information used for legal purposes (for
example, meeting the prudent layperson standard) is not lost. They
urged caution and requested that CMS not immediately implement any
major changes. They recommended refocusing documentation on presenting
conditions and medical decision-making. Some commenters were supportive
of leaving it largely to the discretion of individual practitioners to
determine the degree to which they should perform and document the
history and physical exam in the emergency department setting. Other
commenters suggested that CMS encourage use of standardized guidelines
and minimum documentation requirements to facilitate post-treatment
evaluation, as well as analysis of records for various clinical, legal,
operational and other purposes. The commenters discussed the importance
of extensive histories and exams in emergency departments, where
usually there is no established relationship with the patient and
differential diagnosis is critical to rule out many life-threatening
conditions. They were cognizant of the need for a clear record of
services rendered and the medical necessity for each service,
procedure, diagnostic test, and MDM performed for every patient
encounter.
In addition, although the RUC is in the process of revaluing this
code set, some commenters stated that the main issue is not that the
emergency department visit codes themselves are undervalued. Rather,
these commenters noted that a greater percentage of emergency
department visits are at a higher acuity level, yet payers often do not
pay at a higher level of care and the visit is often inappropriately
down-coded based on retrospective review. These commenters noted that
the documentation needed to support a higher level of care is too
burdensome or subjective. In addition, it seems that policy proposals
regarding emergency department visits billed by physicians might best
be coordinated with parallel changes to payment policy for facility
billing of these codes, which would require more time and analyses.
Accordingly, we did not propose any changes to the emergency
department E/M code set or to the E/M code sets for settings of care
other than office-based and outpatient settings at this time. However,
we solicited public comment on whether we should make any changes to it
in future years, whether by way of documentation, coding, and/or
payment and, if so, what the changes should be.
Consistent with public feedback to date, we are taking a step-wise
approach and limiting our policy proposals this year to the office/
outpatient E/M code set (and the limited proposal above regarding
documentation of medical necessity for home visits in lieu of office
visits). We may consider expanding our efforts more broadly to
additional sections of the E/M visit code set in future years, and
solicited public comment broadly on how we might proceed in this
regard.
We received a few comments on this solicitation. We thank the
commenters for their feedback and will take it into account for future
rulemaking.
(h) Implementation Date
We proposed that our proposed E/M visit policies would be effective
January 1, 2019. However, we were sensitive to commenters' suggestions
that we should consider a multi-year process and proceed cautiously,
allowing adequate time to educate practitioners and their staff; and to
transition clinical workflows, EHR templates, institutional processes
and policies (such as those for provider-based practitioners), and
other aspects of practitioner work that would be impacted by these
policy changes. We emphasized that our proposed documentation changes
for office/outpatient E/M visits would be optional, and practitioners
could choose to continue to document these visits using the current
framework and rules, which may reduce the need for a delayed
implementation. Nevertheless, practitioners who choose a new
documentation framework may need time to deploy it. A delayed
implementation date for our documentation proposals would also allow
the AMA time to develop changes to the CPT coding definitions and
guidance prior to our implementation, such as changes to MDM or code
definitions that we could then consider for adoption. It would also
allow other payers time to react and potentially adjust their policies.
Accordingly, we solicited comment on whether a delayed implementation
date, such as January 1, 2020, would be appropriate for our proposals.
Comment: With the exception of several documentation proposals,
most of the commenters urged us not to finalize the E/M visit
proposals, or to delay their implementation by at least one year. With
the exception of our proposals regarding home E/M visits and reducing
redundant recording of data, most commenters recommended that CMS
engage in further work with the AMA and other stakeholders in the
coming months to develop alternative approaches. Many commenters noted
that our proposals regarding home E/M visits and reducing redundant
recording of data would not impact payment or require extensive
training or other extended preparatory time. The commenters largely
recommended that CMS finalize these proposals for 2019,

[[Page 59653]]

but defer other documentation, coding and payment reforms to future
years after obtaining additional stakeholder input. Some commenters did
recommend that CMS finalize the proposed policy to allow choice among
documentation methodologies while working with stakeholders to refine
any coding and payment changes. A few commenters were supportive of a
minimum level 2 documentation standard and intimated that this could be
accomplished without changes to coding or payment, but other commenters
opposed this approach.
Many stakeholders, including some commercial insurers and EHR-
related associations, commented that if CMS were to finalize its
proposals, the industry would need more time to prepare and CMS should
delay implementation a year or more. Some commenters noted that CMS
should consider not setting a date for implementation until the
necessary structure is in place. Most commenters, including some
insurers, urged CMS to work with the AMA or other stakeholders on
alternative policies. For example, some insurers were concerned that
the proposals would not allow them to understand the true complexity of
care being delivered and recommended that documentation requirements
should continue to be linked to complexity and, if the proposal were
finalized, CMS would need to monitor various program integrity issues.
They were concerned that the collapsed payment rate for level 2 through
5 E/M visits would disincentivize treatment of complex patients. Some
health plans expressed concern that medical record data used to inform
their payments and risk adjustment and HEDIS scores might be impacted.
In response to our proposed rule, several organizations stated they are
forming workgroups to conduct data analysis and develop policy
alternatives, including the AMA and the Cognitive Care Alliance. The
American Health Insurance Plans believed documentation requirements
should continue to be linked to complexity.
Commenters were concerned there would not be enough time for
developers and clinicians to make changes, leading to confusion in the
market and disparate systems with other payers, in addition to other
concerns about the coding and payment proposals discussed further
below. The commenters were concerned about not having enough time to
develop differing documentation based on payer status, and said that
the burden on the clinician to determine which payer and which
documentation method should not be underestimated.
Response: After consideration of public comments, we are not
finalizing aspects of our proposal that would have reduced payment when
E/M office/outpatient visits are furnished on the same day as certain
procedures, established separate podiatric E/M visit codes, or
standardized the allocation of PE RVUs for E/M visit codes. After
considering the comments, for 2019 we are finalizing several of our
documentation proposals that will provide some significant and
immediate burden reduction but are unrelated to changes to payment and
coding. Specifically, we are finalizing the proposals regarding home
visits and redundant data recording (discussed above), as proposed and
effective January 1, 2019. We are delaying implementation of our other
final policies relating to payment for E/M visits to January 1, 2021.

J. Teaching Physician Documentation Requirements for Evaluation and
Management Services

1. Background
Per 42 CFR part 415, subpart D, Medicare Part B makes payment under
the PFS for teaching physician services when certain conditions are
met, including that medical record documentation must reflect the
teaching physician's participation in the review and direction of
services performed by residents in teaching settings. Under Sec.
415.172(b), for certain procedural services, the participation of the
teaching physician may be demonstrated by the notes in the medical
records made by a physician, resident, or nurse; and for E/M visits,
the teaching physician is required to personally document their
participation in the medical record. We received stakeholder feedback
suggesting that documentation requirements for E/M services furnished
by teaching physicians are burdensome and duplicative of notations that
may have previously been included in the medical records by residents
or other members of the medical team.
2. Implementation
We proposed to revise our regulations to eliminate potentially
duplicative requirements for notations that may have previously been
included in the medical records by residents or other members of the
medical team. These modifications are intended to align and simplify
teaching physician E/M service documentation requirements. We believed
these changes would reduce burden and duplication of effort for
teaching physicians. We proposed to amend Sec. 415.172(b) to provide
that, except for services furnished as set forth in Sec. Sec. 415.174
(concerning an exception for services furnished in hospital outpatient
and certain other ambulatory settings), 415.176 (concerning renal
dialysis services), and 415.184 (concerning psychiatric services), the
medical records must document that the teaching physician was present
at the time the service is furnished. Additionally, the revised
paragraph would specify that the presence of the teaching physician
during procedures and E/M services may be demonstrated by the notes in
the medical records made by a physician, resident, or nurse. We also
proposed to amend Sec. 415.174, by deleting paragraph (a)(3)(v) which
requires the teaching physician to document the extent of their
participation in the review and direction of the services furnished to
each beneficiary. We proposed to add new paragraph (a)(6) to Sec.
415.174 to provide that the medical record must document the extent of
the teaching physician's participation in the review and direction of
services furnished to each beneficiary, and that the extent of the
teaching physician's participation may be demonstrated by the notes in
the medical records made by a physician, resident, or nurse.
Comment: Many commenters supported the proposed regulatory changes
without modifications.
Response: We appreciate the commenters' support of our proposals.
Comment: Some commenters disagreed with the proposed changes and
indicated teaching physicians should continue to be personally
responsible for documenting their physical presence and for
verification with patients of all medical team members' documentation
as it relates to the patient encounters. The commenters were concerned
that the proposed changes would shift the documentation burden and
responsibility from the teaching physician to the resident or nurse who
has a limited number of hours of work. One commenter stated that the
nurse would not be an inherent party to the teaching physician's or
resident's involvement in an E/M service.
Response: While we appreciate the commenters' concerns, the purpose
of these revisions to the regulations is to eliminate potentially
duplicative requirements for notations that may have previously been
included in the medical records by residents or other members of the
medical team. The teaching physician continues to be

[[Page 59654]]

responsible for reviewing and verifying the accuracy of notations
previously included by residents and members of the medical team, along
with further documenting the medical record if the notations previously
provided did not accurately demonstrate the teaching physician's
involvement in an E/M service. After consideration of the comments
received, we are finalizing the proposed changes to Sec. Sec.
415.172(b) and 415.174 without modification.

K. GPCI Comment Solicitation

Section 1848(e)(1)(C) of the Act requires us to review and, if
necessary, adjust the GPCIs at least every 3 years. Section
1848(e)(1)(D) of the Act requires us to establish the GPCIs using the
most recent data available. The last GPCI update was implemented in CY
2017; therefore, we are required to review and make any necessary
revisions to the GPCIs for CY 2020. Please refer to the CY 2017 PFS
final rule with comment period for a discussion of the last GPCI update
(81 FR 80261 through 80270). Some commenters have continued to express
concerns regarding some of the data sources used in developing the
indices for PFS geographic adjustment purposes, specifically that we
use residential rent data as a proxy for commercial rent in the rent
index component of the PE GPCI--that is, the data that are used to
develop the office rent component of the PE GPCI. We will continue our
efforts to identify a nationally representative commercial rent data
source that could be made available to CMS. In support of that effort,
we were particularly interested in, and solicited comments regarding
potential sources of commercial rent data for potential use in the next
GPCI update for CY 2020.
We received a few comments in response to the comment solicitation,
and we appreciate the commenters' feedback and input. We will consider
the suggestions and information received for future rulemaking, and in
particular for the CY 2020 statutorily required update to the GPCIs.

L. Therapy Services

1. Repeal of the Therapy Caps and Limitation To Ensure Appropriate
Therapy
Section 50202 of the Bipartisan Budget Act of 2018 amended section
1833(g) of the Act, effective January 1, 2018, to repeal the
application of the Medicare outpatient therapy caps and the therapy cap
exceptions process while retaining and adding limitations to ensure
therapy services are furnished when appropriate. Section 50202 also
adds section 1833(g)(7)(A) of the Act which requires that after
expenses incurred for the beneficiary's outpatient therapy services for
the year have exceeded one or both of the previous therapy cap amounts,
all therapy suppliers and providers must continue to use an appropriate
modifier such as the KX modifier on claims for subsequent services in
order for Medicare to pay for the services. We implemented this
provision by continuing to use the existing KX modifier. By applying
the KX modifier to the claim, the therapist or therapy provider is
confirming that the services are medically necessary as justified by
appropriate documentation in the medical record. Just as with the
incurred expenses for the prior therapy cap amounts, there is one
amount for physical therapy (PT) and speech language pathology (SLP)
services combined and a separate amount for occupational therapy (OT)
services. These KX modifier threshold amounts are indexed annually by
the Medicare Economic Index (MEI). For CY 2018, the KX modifier
threshold amount was $2,010 for PT and SLP services combined, and
$2,010 for OT. After the beneficiary's incurred expenditures for
outpatient therapy services exceed the KX modifier threshold amount for
the year, claims for outpatient therapy services without the KX
modifier are denied.
Along with the KX modifier thresholds, section 50202 also adds
section 1833(g)(7)(B) of the Act that retains the targeted medical
review (MR) process (first established through section 202 of the
Medicare Access and CHIP Reauthorization Act of 2015 (MACRA)), but at a
lower threshold amount of $3,000. For CY 2018 (and each successive
calendar year until 2028, at which time it is indexed annually by the
MEI), the MR threshold is $3,000 for PT and SLP services and $3,000 for
OT services. The targeted MR process means that not all claims
exceeding the MR threshold amount are subject to review as they once
were.
Section 1833(g)(8) of the Act, as re-designated by section 50202 of
the Bipartisan Budget Act of 2018, retains the provider liability
procedures which first became effective January 1, 2013, extending
limitation of liability protections to beneficiaries who receive
outpatient therapy services, when services are denied for certain
reasons, including failure to include a necessary KX modifier.
2. Payment for Outpatient PT and OT Services Furnished by Therapy
Assistants
Section 53107 of the Bipartisan Budget Act of 2018 (BBA of 2018)
amended the Act to add a new subsection 1834(v) that addresses payment
for outpatient therapy services for which payment is made under section
1848 or section 1834(k) of the Act that are furnished on or after
January 1, 2022, in whole or in part by a therapy assistant (as defined
by the Secretary). The new section 1834(v)(1) of the Act provides for
payment of those services at 85 percent of the otherwise applicable
Part B payment amount for the service. In accordance with section
1834(v)(1) of the Act, the reduced payment amount for such outpatient
therapy services is applicable when payment is made directly under the
PFS as specified in section 1848 of the Act, for example when payment
is made to therapists in private practice (TPPs); and when payment is
made based on the PFS as specified in section 1834(k)(3) of the Act,
for example, when payment is made for outpatient therapy services
identified in sections 1833(a)(8) and (9) of the Act, including payment
to providers that submit institutional claims for therapy services such
as outpatient hospitals, rehabilitation agencies, skilled nursing
facilities, home health agencies and comprehensive outpatient
rehabilitation facilities (CORFs). The reduced payment rate under
section 1834(v)(1) of the Act for outpatient therapy services when
furnished in whole or in part by a therapy assistant is not applicable
to outpatient therapy services furnished by critical access hospitals
for which payment is made as specified in section 1834(g) of the Act.
To implement this payment reduction, section 1834(v)(2)(A) of the
Act requires us to establish a new modifier, in a form and manner
specified by the Secretary, by January 1, 2019 to indicate, in the case
of an outpatient therapy service furnished in whole or in part by a
therapy assistant, that the service was furnished by a therapy
assistant. Although we generally consider all genres of outpatient
therapy services together (PT/OT/SLP), we did not believe there are
therapy assistants in the case of SLP services, so we proposed to apply
the new modifier only to services furnished in whole or in part by a
physical therapist assistant (PTA) or an occupational therapy assistant
(OTA). Section 1834(v)(2)(B) of the Act requires that each request for
payment or bill submitted for an outpatient PT or OT

[[Page 59655]]

service furnished in whole or in part by a therapy assistant on or
after January 1, 2020, must include the established modifier. As such,
the modifier will be required to be reported on claims for outpatient
PT and OT services with dates of service on and after January 1, 2020,
when the service is furnished in whole or in part by a therapy
assistant, regardless of whether the reduced payment under section
1834(v)(1) of the Act is applicable. However, the required payment
reductions do not apply for these services until January 1, 2022, as
required by section 1834(v)(1) of the Act.
To implement this provision, we proposed to establish two new
modifiers to separately identify PT and OT services that are furnished
in whole or in part by PTAs and OTAs, respectively. We proposed to
establish two modifiers because the incurred expenses for PT and OT
services are tracked and accrued separately in order to apply the two
different KX modifier threshold amounts as specified by section
1833(g)(2) of the Act; and the use of the two proposed modifiers would
facilitate appropriate tracking and accrual of services furnished in
whole or in part by PTAs and OTAs. We additionally proposed that these
two new therapy modifiers would be added to the existing three therapy
modifiers--GP, GO, and GN--that are currently used to identify all
therapy services delivered under a PT, OT or SLP plan of care,
respectively. The addition of the two new modifiers as therapy
modifiers would bring the total to five therapy modifiers, with four
therapy modifiers used to report and track PT and OT services, instead
of two. The GP, GO, and GN modifiers have existed since 1998 to track
outpatient therapy services that were subject to the therapy caps.
Although the therapy caps were repealed through amendments made to
section 1833(g) of the Act by section 50202 of the Bipartisan Budget
Act of 2018, as discussed in the above section, the statute continues
to require that we track and accrue incurred expenses for all PT, OT,
and SLP services, including those above the specified per beneficiary
amounts for medically necessary therapy services for each calendar
year; one amount for PT and SLP services combined, and another for OT
services.
For purposes of implementing section 1834(v) of the Act through
rulemaking as required under section 1834(v)(2)(C) of the Act, we
proposed to define therapy assistant as an individual who meets the
personnel qualifications set forth at Sec. 484.4 of our regulations
for a PTA and OTA. We proposed that the two new therapy modifiers would
be used to identify services furnished in whole or in part by a PTA or
an OTA; and, that these new therapy modifiers would be used instead of
the GP and GO modifiers that are currently used to report PT and OT
services delivered under the respective plan of care whenever the
service is furnished in whole or in part by a PTA or OTA.
Effective for dates of service on and after January 1, 2020, the
new therapy modifiers that identify services furnished in whole or in
part by a PTA or OTA would be required to be used on all therapy claims
instead of the existing modifiers GP and GO, respectively. As a result,
in order to implement the provisions of the new subsection 1834(v) of
the Act and carry out the continuing provisions of section 1833(g) of
the Act as amended, we proposed that, beginning in CY 2020, five
therapy modifiers be used to track outpatient therapy services instead
of the current three. These five therapy modifiers would include two
new therapy modifiers to identify PT and OT services furnished by PTAs
and OTAs, respectively, and three existing therapy modifiers--GP, GO
and GN--that will be used when PT, OT, and SLP services, respectively,
are fully furnished by therapists or when fully furnished by or
incident to physicians and NPPs.
The creation of therapy modifiers specific to PT or OT services
delivered under a plan of care and furnished in whole or in part by a
PTA or OTA would necessitate that we make changes to the descriptors of
the existing GP and GO modifiers to clarify which qualified
professionals, for example, therapist, physician, or NPP, can furnish
the PT and OT services identified by these modifiers, and to
differentiate them from the therapy modifiers specific to the services
of PTAs and OTAs. We also proposed to revise the GN modifier descriptor
to conform to the changes to the GP and GO modifiers by clarifying the
qualified professionals that furnish SLP therapy services.
We proposed to define the two new therapy modifiers for services
furnished in whole or in part by therapy assistants and to revise the
existing therapy modifier descriptors as follows:
New PT Assistant services modifier (to be used instead of
the GP modifier currently reported when a PTA furnishes services in
whole or in part): Services furnished in whole or in part by a physical
therapist assistant under an outpatient physical therapy plan of care;
New OT Assistant services modifier (to be used instead of
the GO modifier currently reported when an OTA furnishes services in
whole or in part): Services furnished in whole or in part by
occupational therapy assistant under an outpatient occupational therapy
plan of care.
We proposed that the existing GP modifier, ``Services delivered
under an outpatient physical therapy plan of care'' would be revised to
read as follows:
Revised GP modifier: Services fully furnished by a
physical therapist or by or incident to the services of another
qualified clinician--that is, physician, nurse practitioner, certified
clinical nurse specialist, or physician assistant--under an outpatient
physical therapy plan of care.
We proposed that the existing GO modifier, ``Services delivered
under an outpatient occupational therapy plan of care'' would be
revised to read as follows:
Revised GO modifier: Services fully furnished by an
occupational therapist or by or incident to the services of another
qualified clinician--that is, physician, nurse practitioner, certified
clinical nurse specialist, or physician assistant--under an outpatient
occupational therapy plan of care.
We proposed that the existing GN modifier, ``Services delivered
under an outpatient speech-language pathology plan of care'' would be
revised to be consistent with the revisions to the GP and GO modifiers
to read as follows:
Revised GN modifier: Services fully furnished by a speech-
language pathologist or by or incident to the services of another
qualified clinician--that is, physician, nurse practitioner, certified
clinical nurse specialist, or physician assistant--under an outpatient
speech-language pathology plan of care.
As finalized in CY 2005 PFS final rule with comment period (69 FR
66351 through 66354), and as required as a condition of payment under
our regulations at Sec. Sec. 410.59(a)(3)(iii), 410.60(a)(3)(iii), and
410.62(a)(3)(iii), the person furnishing outpatient therapy services
incident to the physician, PA, NP or CNS service must meet the
therapist personnel qualification and standards at Sec. 484.4, except
for licensure per section 1862(a)(20) of the Act. As such, we noted
that only a therapist, not a therapy assistant, can furnish outpatient
therapy services incident to the services of a physician or a non-
physician practitioner (NPP), so the new PT- and OT-Assistant therapy
modifiers cannot be used on the line of service when the rendering
practitioner identified on the claim is a physician or an NPP. For
therapy services billed by physicians or NPPs, whether furnished

[[Page 59656]]

personally or incident to their professional services, the GP or GO
modifier is required for those PT or OT services furnished under an
outpatient therapy plan.
We proposed that all services that are furnished in whole or in
part by a PTA or OTA are subject to the use of the new therapy
modifiers. A new therapy modifier would be required to be used whenever
a PTA or OTA furnishes all or part of any covered outpatient therapy
service. However, we did not believe the provisions of section 1834(v)
of the Act were intended to apply when a PTA or OTA performs portions
of the service such as administrative tasks that are not related to
their qualifications as a PTA or OTA. Rather, we believed the
provisions of section 1834(v) of the Act were meant to apply when a PTA
or OTA is involved in providing some or all of the therapeutic portions
of an outpatient therapy service. We proposed to define ``in part,''
for purposes of the proposed new modifiers, to mean any minute of the
outpatient therapy service that is therapeutic in nature, and that is
provided by the PTA or OTA when acting as an extension of the
therapist. Therefore, a service furnished in part by a therapy
assistant would not include a service for which the PTA or OTA
furnished only non-therapeutic services that others without the PTA's
or OTA's training can do, such as scheduling the next appointment,
greeting and gowning the patient, and preparing or cleaning the room.
We remind therapists and therapy providers that we do not recognize
PTAs and OTAs to wholly furnish PT and OT evaluations and
reevaluations, that is, CPT codes 97161 through 97164 for PT and CPT
codes 97165 through 97168 for OT, but to the extent that they do
furnish part of an evaluative service, the appropriate therapy modifier
must be used on the claim to signal that the service was furnished in
part by the PTA or OTA, and the payment reduction should be applied
once it goes into effect. We continue to believe that the clinical
judgment and decision making involved in furnishing an evaluation or
re-evaluation is similar to that involved with establishing the therapy
plan that can only be established by a therapist, physician, or NPP
(NP, CNS, or PA) as specified in Sec. 410.61 of our regulations. In
addition, PTAs and OTAs are not recognized separately in the statute to
enroll as practitioners for purposes of independently billing for their
services under the Medicare program. For these reasons, Pub. 100-02,
Medicare Benefits Policy Manual, Chapter 15, sections 230.1 and 230.2
state that PTAs and OTAs may not provide evaluative or assessment
services, make clinical judgments or decisions; develop, manage, or
furnish skilled maintenance program services; or take responsibility
for the service. Although we expect that the therapist will continue to
furnish the majority of an evaluative procedure service, section
1834(v)(1) of the Act requires that the adjusted payment amount (85
percent of the otherwise applicable Part B payment amount) be applied
when a therapy assistant furnishes a therapy service in part, including
part of an evaluative service.
Additionally, we would like to clarify that the requirements for
evaluations, including those for documentation, are separate and
distinct from those for plans of care (plans). The plan is a statutory
requirement under section 1861(p) of the Act for outpatient PT services
(and through sections 1861(g) and 1861(ll)(2) of the Act for outpatient
OT and SLP services, respectively) and may only be established by a
therapist or physician. Through Sec. 410.61(b)(5), NPs, CNSs, and PAs
are also permitted to establish the plan. This means that if the
evaluative procedure is furnished in part by an assistant, the new
therapy modifiers that distinguish services furnished by PTAs or OTAs
must be applied to the claim; however, the plan, which is not
separately reported or paid, must be established by the supervising
therapist who furnished part of the evaluation services as specified at
Sec. 410.61(b). When an evaluative therapy service is billed by a
physician or an NPP as the rendering provider, either the physician/NPP
or the therapist furnishing the service incident to the services of the
physician or NPP, may establish the therapy plan in accordance with
Sec. 410.61(b). All regulatory and subregulatory plan requirements
continue to apply.
To implement the new statutory provision at section 1834(v)(2)(A)
of the Act, we proposed to establish two new therapy modifiers to
identify the services furnished in whole or in part by PTAs and OTAs.
As required under section 1834(v)(2)(B) of the Act, claims from all
providers of PT and OT services furnished on and after January 1, 2020,
will be required to include these new PT- and OT-Assistant therapy
modifiers for services furnished in whole or in part by a PTA or OTA.
We proposed that these therapy modifiers would be required, when
applicable, in place of the GP and GO modifiers currently used to
identify all PT and OT services furnished under an outpatient plan of
care, including the services furnished by PTAs and OTAs. To test our
systems ahead of the required implementation date of January 1, 2020,
we anticipated allowing voluntary reporting of the new modifiers at
some point during CY 2019, which we would announce to our contractors,
therapists and therapy providers through a Change Request, as part of
our usual change management process.
We solicited comments on these proposals.
The following is a summary of the comments we received on these
proposals.
Comment: Some commenters opposed paying differently for the
services furnished in whole or in part by OTAs and PTAs while other
commenters supported the payment differential, with a few comparing it
to the 85 percent payment rate for certain NPPs.
Response: While we appreciate hearing various commenters' views,
the new statutory provision at section 1834(v) of the Act added by
section 53107 of the Bipartisan Budget Act of 2018 (Pub. L. 115-123,
enacted February 9, 2018) requires CMS to implement through notice and
comment rulemaking a reduced rate for the services furnished on or
after January 1, 2022, in whole or in part by therapy assistants at 85
percent of the otherwise applicable Part B payment amount for the
service. Section 1834(v) of the Act further requires that we establish
a modifier to identify services furnished in whole or in part by a
therapy assistant by January 1, 2019, and that claims for outpatient
therapy services furnished in whole or in part by therapy assistant on
or after January 1, 2020, must include the modifier. As such, we are
following statutory directives to implement section 1834(v) of the Act.
Comment: Some commenters supported our proposal to establish two
modifiers, instead of one, to separately identify PT and OT services
that are furnished in whole or in part by PTAs and OTAs, respectively.
Several commenters expressed support for our proposal defining therapy
assistant as an individual who meets the personnel qualifications set
forth in Sec. 484.4 of our regulations for PTAs and OTAs.
Response: We thank the many commenters who supported our proposals
to (a) establish two new modifiers instead of one to separately define
therapy assistant services furnished by PTAs and OTAs, and (b) to
define the PTA and OTA as individuals who meet the personnel
qualifications set forth in regulations at 42 CFR part 484. Although we
stated that these personnel qualifications were located at Sec. 484.4,
we note that, effective January 13, 2018, the personnel qualifications
for PTAs and OTAs were moved from

[[Page 59657]]

Sec. 484.4 and redesignated without changes at Sec. Sec. 484.115(g)
and (i), respectively (82 FR 4504, January 13, 2017).
Comment: Most commenters did not choose to comment specifically
about our proposal to establish the two new modifiers as therapy
modifiers for services furnished by PTAs and OTAs that are to be used
instead of the current GP and GO modifiers used to capture the these
services. However, several commenters opposed the structure we proposed
for the modifiers that would be required on therapy claims when
services are furnished by PTAs and OTAs which would change from the
current two therapy modifiers, GP and GO, to identify all therapy
services delivered under an outpatient PT or OT plan of care, to four
therapy modifiers. Instead, they urged us to adopt new modifiers that
would be used in tandem with, rather than replace, the respective
existing GP and GO therapy modifiers on the same claim line of service
to identify services delivered in whole or in part by PTAs and OTAs.
The commenters stated that their suggested approach would mitigate
administrative burden for all PT and OT professionals, as well as
therapy assistants. Specifically, commenters stated that their
therapists and therapy assistants use the same chargemasters, and their
charge systems are hardcoded to default to either the PT or OT therapy
modifier (GP or GO) that are now required on these claims, which saves
both the therapists and therapy assistants from having to add the GP or
GO therapy modifier to each claim line for the services they furnish.
According to the commenters, under our proposal, both therapists and
assistants would have to add one of the four modifiers for PT and OT
services to the claim line and they would no longer be able to default
their charge systems to report the GP or GO modifiers. This would mean
that new PTA- and OTA-specific systems would need to be duplicated,
creating undue chargemaster confusion and adding training and education
burden to both therapists and therapy assistants for reporting one the
four therapy modifiers. The commenters stated that adopting their
proposal to add the new therapy assistant modifiers to the same claim
line of service alongside the existing GP and GO modifiers eliminates
the administrative burden on therapists since only therapy assistants
would be required to use the new modifiers, and charge systems could
remain hardcoded to default to the GP or GO modifiers as they are now
to include all PT and OT services.
Response: We appreciate the commenters' concerns and agree that
their suggested approach to use the new modifiers for services
furnished in whole or in part by PTAs and OTAs on the same line of
service as the existing GP and GO therapy modifiers, instead of
replacing them, has merit, since it preserves the current use of the GP
and GO therapy modifiers to identify outpatient therapy services
furnished by both therapists and therapy assistants under a PT or OT
plan of care. We also agree that adding the new therapy assistant
modifiers to the same claim line of service alongside the existing GP
and GO modifiers will prevent undue burden for physical therapists and
occupational therapists, as only PTAs and OTAs will add the new
modifiers to the claim line of service.
After considering the comments on the establishment and use of the
new modifiers, the statutory changes, and our other payment policies
for therapy services, we are not finalizing the new modifiers for
therapy assistant services as therapy modifiers as proposed. Instead,
we will use the two new modifiers for therapy assistant services as a
type of payment modifier that will be used alongside of, instead of
replacing, the GP and GO therapy modifiers, to identify the services
furnished in whole or in part by PTAs or OTAs that will be tied to the
reduced payment for the respective PT or OT discipline in CY 2022. By
using the new modifiers for therapy assistants as payment modifiers,
rather than therapy modifiers, services furnished by PTAs and OTAs will
continue to be captured by the GP and GO therapy modifiers, as they are
now, when delivered under the an outpatient PT or OT plan of care,
respectively. We considered the commenters' requests not to use the two
new modifiers for services furnished by PTAs and OTAs as therapy
modifiers in addition to the current two therapy modifiers, GP and GO,
respectively. We took into account their concerns about the reporting
burden for both therapists and therapy assistants that would result if
we were to double the number of therapy modifiers used to report the
services delivered under PT and OT plans of care. We also considered
the unintended consequences that could result from changing the long-
standing nature of our three existing discipline-specific therapy
modifiers used to report all services delivered under an outpatient
plan of care for PT, OT, and SLP services. These consequences could be
significant, especially since the existing modifiers are used by many
other government payers and private insurers. Additionally, our claims
processing systems have numerous edits tied to the therapy modifiers
because these modifiers are used to track and accrue incurred costs of
therapy services furnished under the outpatient therapy benefit by
therapists and their assistants, as well as those services that
physicians and NPPs furnish and bill as therapy services. Consequently,
we agree with commenters that it is preferable to use the two new
modifiers as payment modifiers to identify the services furnished in
whole or in part by therapy assistants, instead of changing the overall
configuration of our therapy modifiers established through CY 1998
rulemaking and designed to track services to the then therapy cap
amounts for outpatient therapy services furnished under PT, OT, and SLP
plans of care.
This approach--using payment modifiers rather than therapy
modifiers--necessitates revisions to the descriptors we proposed for
the new therapy assistant modifiers. As therapy modifiers, the new
modifiers were proposed to define the PTA or OTA services delivered
under an outpatient PT or OT plan of care, respectively. Modifying our
proposal to instead use the two new modifiers as payment modifiers, we
are removing references to the services being delivered under an
outpatient PT or OT plan of care because the plan is specific to the GP
and GO therapy modifiers. We also retained the terminology of ``in
whole or in part'' as part of the definition of these therapy assistant
payment modifiers, as specified at section 1834(v) of the Act, and
clarified the therapy assistants' services are included as part of the
corresponding PT or OT discipline. As a result, we are finalizing the
two new payment modifiers to identify services furnished in whole or in
part by a PTA and OTA, modifiers CQ and CO (C, capital letter O),
respectively as follows.
PTA Modifier CQ: Outpatient physical therapy services
furnished in whole or in part by a physical therapist assistant.
OTA Modifier CO: Outpatient occupational therapy services
furnished in whole or in part by an occupational therapy assistant.
Because we are establishing the two new modifiers for the services
furnished in whole or in part by a PTA or OTA as payment modifiers
instead of as therapy modifiers, it is no longer necessary to revise
the existing GP, GO, and GN therapy modifiers as we initially proposed
to differentiate which professionals may furnish services using the GP,
GO, and GN therapy modifiers in the absence of therapy modifiers used

[[Page 59658]]

specifically to identify services furnished in whole or in part by PTAs
and OTAs. As a result, we are not finalizing our proposal to change the
descriptors for the current therapy modifiers: GP, GO and GN--their
descriptors and their use remains unchanged, as follows:
GP--services delivered under an outpatient physical
therapy plan of care.
GO--services delivered under an outpatient occupational
therapy plan of care.
GN--services delivered under an outpatient speech-language
pathology plan of care.
As part of the proposed rule, we noted that therapy assistants are
precluded from furnishing outpatient therapy services incident to the
services of a physician or NPP, and as such, the new PTA and OTA
modifiers cannot be used on the line of service of the professional
claim when the rendering NPI identified on the claim is a physician or
an NPP. This is because PTAs and OTAs don't meet the qualifications of
a physical or occupational therapist that is set forth as conditions of
payment in the regulatory provisions at Sec. Sec. 410.59(a)(3)(iii)
and 410.60(a)(3)(iii). We are clarifying that this payment policy
applies similarly when the CQ and CO modifiers are used as payment
modifiers. We plan to revise our manual provisions at Pub. 100-02,
Medicare Benefit Policy Manual, Chapter 15, section 230, as
appropriate, to reference the new CQ and CO modifiers that will be used
to identify services furnished in whole or in part by a PTA or OTA
starting in CY 2020.
Comment: Several commenters referenced therapist and therapy
assistant shortages, and stated that this discounted payment rate for
services furnished in whole or in part by therapy assistants will
increase financial hardships to retain therapists and therapy
assistants. Commenters requested that CMS exempt therapy services
furnished in rural areas, health professional shortage areas (HPSAs),
and medically underserved areas (MUAs) from application of the reduced
payment rate when a therapy assistant is involved.
Response: We understand the commenters' concerns. Given the
parameters of the statute at section 1834(v) of the Act, we do not have
authority to exempt services furnished in whole or in part by therapy
assistants from application of the reduced payment rate when furnished
in rural areas, HPSAs, and MUAs. As we do for other services, we will
monitor for potential access issues and consider how to address them
should they arise. We do not currently have information on the
geographic distribution or quantity of services furnished in whole or
in part by PTAs and OTAs, and look forward to reviewing this
information as it becomes available after January 1, 2020, when the new
therapy assistant modifiers are required to be reported on claims.
Comment: Many commenters expressed concerns about different aspects
of our proposed interpretation of the statutory reference to services
furnished ``in whole or in part'' by PTAs and OTAs. Commenters also
expressed concern about our proposal to define ``in part'' to mean any
minute of therapeutic services delivered by a PTA or OTA. Several
commenters raised concerns about the reduced payment associated with
the future use of the new modifiers to describe services furnished in
whole or in part by PTAs and OTAs, and asked us to consider the
practical day-to-day implications of using these modifiers. These
commenters stated that requiring the new modifiers to be applied when
any minute of outpatient therapy is delivered by the PTA or OTA has
serious implications for beneficiary access to care.
Some commenters stated that documenting in the medical record the
therapy services that are delivered in part by a therapy assistant will
be burdensome for those services not fully or wholly furnished by an
OTA or PTA, and some suggested that the reduced payment rates should
only apply when the PTA or OTA furnishes the entire service.
Many commenters objected to our definition of ``in part'' and
offered several alternatives. Some commenters suggested that we should
not define when a PTA or OTA furnishes a service in whole or in part,
but instead consider whether a therapist furnishes a service in whole
or in part, stating that the PTA/OTA modifiers should not apply in
cases where the therapist, not the assistant, furnishes the majority of
the service.
Several commenters were concerned that applying the modifier when
any minute of outpatient therapy is delivered by a therapy assistant
has serious implications for beneficiary access to care and asked us to
not finalize the definition of ``in part'' until CY 2020 rulemaking,
when the new modifiers for services of therapy assistants are required
on claims. The commenters stated that this delay would allow CMS
additional time to engage in an extensive discussion with various
external stakeholders in order to consider their input before CY 2020
rulemaking. Instead of waiting to define ``in part'' during CY 2020
rulemaking, one commenter suggested that we adopt a blended fee
schedule rate for services furnished for more than 50 percent of the
time by a therapist, including the services of both the 15-minute timed
codes or untimed service-based codes, meaning that the rate paid would
be 92.5 percent, halfway between 85 and 100 percent. Other commenters
stated that the modifiers to identify services of PTAs and OTAs should
not apply when the therapist fully furnished the services and the
assistant merely lent a second pair of hands during the treatment for
example, for safety reasons, such as where the patient is morbidly
obese or has flaccid limb(s) and the completion of such services
require more than one therapy professional.
Many commenters raised concerns about the application of our
definition of ``in part'' when therapists and therapy assistants work
together collaboratively. Some commenters raised concerns about
applying the modifier for therapy assistant services when therapists
and their assistants work interchangeably without a clear line between
when the physical therapist might stop delivering treatment and the
therapy assistant resumes treatment, and when the assistant acts as a
second pair of hands to the therapist. Some commenters stated that when
a therapist and assistant work together in a team-based approach,
regardless of the amount of time the PTA or OTA contributes, that the
new modifiers identifying services for application of the discounted
payment rate should not apply. Some of these commenters requested that
we exclude the use of new modifiers for therapy evaluations and re-
evaluations because a therapy assistant is not permitted to fully
furnish these services and these services require the therapist's
clinical skill, judgment, and decision-making throughout. Others
commenters requested that the modifiers should not apply for group
therapy services, which are often provided collaboratively between the
assistant and therapist because it is not fair to affix the discounted
payment modifier to every patient in the group when a PTA or OTA
furnishes one minute of the group service. Some commenters suggested we
apply an 8-minute rule to the codes defined by 15-minute increments,
stating that the modifiers should apply only when the PTA/OTA furnishes
at least 8 minutes of the service, while other commenters asked us not
to apply the assistant modifiers when these intervention services are
furnished collaboratively by the therapist and

[[Page 59659]]

assistant. Several commenters recommended that CMS allow for reporting
of the same code on the same day for the same beneficiary on two
different claim lines to distinguish between those code units furnished
by a therapist and those furnished by a therapy assistant in reference
to the 15-minute timed intervention codes and the group therapy code
(CPT code 97150).
Response: We acknowledge the views of the many commenters regarding
our proposed interpretation of the statutory reference to therapy
services furnished in whole or ``in part'' by PTAs and OTAs as part of
the requirement that we establish a modifier to identify such services
on claims beginning January 1, 2020, and apply a discounted payment
rate to those services beginning January 1, 2022. We offer
clarification on some of the commenters' concerns and alternatives, as
follows. We do not agree that the statutory provision at section
1834(v) of the Act, which specifies a discounted payment rate for
services furnished ``in whole or in part'' by a therapy assistant,
could be interpreted to apply only when the therapy assistant furnishes
the entire service. We also clarify that the modifiers would not apply
to those services that are exclusively furnished by therapists without
the assistance of PTAs or OTAs. However, the extent to which the
modifiers apply to clinical scenarios in which the therapist and
therapy assistant work together to furnish services collaboratively may
be dependent on whether the therapy assistant's services are furnished
in the absence of the therapist, whose time could then no longer be
attributed to that patient. We do not agree that services in which the
therapist and therapy assistant work collaboratively or in tandem are
necessarily services that are not furnished ``in part'' by a therapy
assistant. Rather, when a therapist and therapy assistant work together
in furnishing a therapy service, we would generally view that service
as being furnished in part by a therapy assistant, especially when the
therapist is absent for a portion of the service, as explained above.
We recognize there are other clinical scenarios and types of services
where it is less obvious whether the service should be considered
furnished ``in part'' by a therapy assistant when a therapist and
therapy assistant work collaboratively together to treat one patient,
and we anticipate addressing applicability of the modifiers in
additional clinical scenarios through further rulemaking for CY 2020.
We also clarify that the statutory provision at section 1834(v) of the
Act requiring the reduced payment at 85 percent for services furnished
in whole or in part by a therapy assistant beginning in CY 2022, does
not permit us to make payment at 92.5 percent, as suggested by some
commenters. We also note the concerns of the few commenters requesting
that we allow the same procedure code for the same patient on the same
day to appear on multiple claim lines, some of which might include the
new modifier for therapy assistant services and others of which would
not. CMS claims processing systems already allow, when not constrained
by other policies such as Medically Unlikely Edits (MUEs), the same
procedure code to be reported on two different claim lines as long as
there is a different modifier used to uniquely identify the service and
prevent the service from being considered a duplicate. For example, if
a therapy assistant furnished one unit (15 minutes) and the therapist
furnished 2 units (30 minutes) of the same procedure code that is
defined to be billable in 15-minute increments, one unit of the
procedure code would be billed on the claim line with the modifier for
the therapy assistant's services and two units of the procedure code
would be billed on another claim line without the assistant modifier.
We do not agree with the commenters' suggestion that we define ``in
part'' to mean a therapy service for which a PTA or OTA furnishes 50
percent or a majority of the service, or an otherwise substantial part
of the service. The discounted payment rate specified under section
1834(v)(1) of the Act is required to be applied for services furnished
``in whole or in part'' by a therapy assistant. We do not believe ``in
whole or in part'' means that the discounted payment rate would apply
only to services for which 50 percent or more of the service was
furnished by a therapy assistant.
In our review of section 1834(v)(1) of the Act, we believe that the
phrase ``in part'' could be read to mean that if a therapy assistant
participates only in a very small (so insubstantial as to not be
meaningful) portion of the service, the discounted payment rate would
not apply. In the proposed rule, we proposed that ``in part'' would not
include the non-therapeutic portions of a service that could be
performed by others without the training of PTAs or OTAs. Along those
same lines, after further consideration of the public comments
explaining the fluid nature of clinical practice between therapists and
therapy assistants and the complexity of identifying and documenting
when a service is furnished in part by a therapy assistant, we believe
it would be appropriate to define a therapy assistant's participation
in furnishing a therapy service ``in part'' to mean that the therapy
assistant furnished more than a de minimis portion of the therapy
service. Specifically, we believe it would be appropriate to specify
that a therapy assistant is considered to furnish a therapy service
``in part'' when they perform more than 10 percent of the service. If,
instead of specifying as we proposed that the modifiers are applicable
when any minute of a therapeutic service is furnished by a PTA or OTA,
we specified that the modifiers apply when more than 10 percent of a
service is furnished by the therapy assistant, 1.5 minutes of a 15-
minute unit could be furnished by the PTA or OTA without being subject
to the discounted payment rate. If this 10 percent de minimis standard
is applied to an untimed service, for example to a therapy evaluation
for which the typical time is 45 minutes, the PTA or OTA could furnish
up to 4.5 minutes of the service before the modifier and discounted
payment rate would apply. We anticipate addressing applicability of the
ten percent de minimis standard for other clinical scenarios in further
rulemaking for CY 2020.
After consideration of the public comments, the following reflects
a full summary of our finalized policies.
We are finalizing the establishment of two modifiers, one to
identify services furnished in whole or in part by PTAs and the other
to identify services furnished in whole or in part by OTAs. We are also
finalizing our proposal to define PTAs and OTAs as those individuals
meeting the personnel qualifications set forth in part 484.
Instead of finalizing the new modifiers to identify services
furnished by PTAs and OTAs as therapy modifiers, we are adopting a
final policy to use these new modifiers as a payment modifier that will
be appended on the same line of service with the respective PT or OT
therapy modifier. This modified approach necessitates revisions to the
proposed descriptors of the new CQ and CO modifiers, and allows us to
proceed without making the proposed revisions to the current
descriptors for the three therapy modifiers--GP, GO and GN. We are
finalizing the new payment modifiers as follows.
CQ Modifier: Outpatient physical therapy services
furnished in whole or in part by a physical therapist assistant.
CO Modifier: Outpatient occupational therapy services
furnished

[[Page 59660]]

in whole or in part by an occupational therapy assistant.
We are not revising the three therapy modifiers as we had proposed.
Instead, they will continue in effect, unmodified, as follows:
GP--services delivered under an outpatient physical
therapy plan of care.
GO--services delivered under an outpatient occupational
therapy plan of care.
GN--services delivered under an outpatient speech-language
pathology plan of care.
Instead of finalizing our proposed definition of a service that is
furnished in whole or in part by a PTA or OTA as a service for which
any minute of a therapeutic service is furnished by a PTA or OTA, we
are finalizing a de minimis standard under which a service is furnished
in whole or in part by a PTA or OTA when more than 10 percent of the
service is furnished by the PTA or OTA. We anticipate addressing
application of the therapy assistant modifiers and the 10 percent
standard more specifically, including their application for different
scenarios and types of services, in rulemaking for CY 2020.
3. Functional Reporting Modifications
Since January 1, 2013, all providers of outpatient therapy
services, including PT, OT, and SLP services, have been required to
include functional status information on claims for therapy services.
In response to the Request for Information (RFI) on CMS Flexibilities
and Efficiencies that was issued in the CY 2018 PFS proposed rule (82
FR 34172 through 34173), we received comments requesting burden
reduction related to the functional reporting requirements that were
adopted to implement section 3005(g) of the Middle Class Tax Relief and
Jobs Creation Act (MCTRJCA) of 2012 (Pub. L. 112-96, January 1, 2013).
More information about these requirements can be found in the CY 2019
PFS proposed rule (83 FR 35852).
We proposed to discontinue the functional reporting requirements
for services furnished on or after January 1, 2019. Specifically, we
proposed to amend our regulations by removing the following: (1)
Conditions of payment at Sec. Sec. 410.59(a)(4), 410.60(a)(4),
410.62(a)(4), and 410.105(d) that require claims for OT, PT, SLP, and
Comprehensive Outpatient Rehabilitation Facility (CORF) PT, OT, and SLP
services, respectively, to contain prescribed information on patient
functional limitations; and, (2) the functional reporting-related
phrase that requires the plan's goals to be consistent with functional
information on the claim at Sec. 410.61(c) for outpatient PT, OT, and
SLP services and at Sec. 410.105(c)(1)(ii) for the PT, OT, and SLP
services in CORFs. In addition, we would (1) remove the functional
reporting subregulatory requirements implemented primarily through
Change Request 8005 last issued on December 21, 2012, via Transmittal
2622, (2) eliminate the functional reporting standard systems edits we
have applied to claims, and (3) remove the functional reporting
requirement provisions in our internet Only Manual (IOM) provisions
including the Medicare Claims Processing Manual, Chapter 5 and the
functional reporting requirements in Chapters 12 and 15 of the Medicare
Benefits Policy Manual.
Our proposal would end the requirements for the reporting and
documentation of functional limitation G-codes (HCPCS codes G8978
through G8999 and G9158 through G9186) and severity modifiers (in the
range CH through CN) for outpatient therapy claims with dates of
service on and after January 1, 2019. Accordingly, with the conclusion
of our functional reporting system for dates of service after December
31, 2018, we proposed to delete the applicable non-payable HCPCS G-
codes specifically developed to implement that system through the CY
2013 PFS final rule with comment period (77 FR 68598 through 68978).
We sought comment on these proposals. The following is a summary of
the comments we received on these proposals.
Comment: Many commenters supported the proposal to eliminate the
functional reporting requirements for outpatient therapy services and
urged us to end these requirements for reporting and documenting the G-
codes and severity modifiers on claims for PT, OT, and SLP services
beginning January 1, 2019. Many commenters agreed that these
requirements are overly complex and burdensome for therapy providers.
Response: We appreciate the commenters' support of our proposal to
end the reporting and documentation requirements effective January 1,
2019.
Comment: Some commenters disagreed with our proposal to end the
functional reporting and documentation requirements beginning in CY
2019. One commenter who liked our functional reporting system suggested
that we retain a reduced version of it. Two other commenters supported
our requirement for assessment tools or outcome measures to be used to
quantify the severity of dysfunction or disability. One commenter
representing a software developer supported the flexibility in our
rules permitting professional judgment of therapists to select from a
composite outcome measure a single functional measure that reflects a
more accurate disability rating. Another commenter representing a large
private payer asked us to retain our functional reporting requirements
because they believe that information about functional status of
therapy patients remains an essential source of information for health
plan care management activities such as health plan care coordination
programs and to accurately complete risk adjustment requirements. This
commenter also noted that the end of Medicare functional reporting
requirements may cause therapists to stop documenting information about
their patients' functional status, and this, along with the repeal of
the therapy caps, could instead prompt therapists to furnish non-
covered long-term custodial care services that are not medically
necessary.
Response: We appreciate the commenters' support for the claims-
based functional reporting system requirements currently in place
including the use by the private payer of the functional status
information reported on claims for health plan care management
activities. While we acknowledge that functional status will no longer
be required to be reported on Medicare claims and, thus, will not be
available for use on claims for health plan care management activities,
we do not share the commenter's concern though that the lack of a
functional reporting requirement to document the non-payable HCPCS
codes and related severity modifiers or the repeal of the therapy caps
will cause therapists to begin furnishing therapy services that do not
meet the statutory requirement for reasonable and necessary services or
keep them from documenting other information required about patients'
physical status in medical records. The documentation requirements
specified in Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15,
section 220.3 titled Documentation Requirements for Therapy Services,
in subsection C. for Evaluation/Re-Evaluation and Plan of Care, which
were established prior to the MCTRJCA provisions' mandate, would remain
in place. These documentation instructions continue to require that
therapists document in the beneficiary's medical record, either in the
evaluation or in the plan of care containing the evaluation, objective,
measurable beneficiary physical function. In order to meet these
requirements, therapists may use one of

[[Page 59661]]

four measurement instruments, including National Outcomes Measurement
System (NOMS) by the American Speech-Language Hearing Association,
Activity Measure--Post Acute Care (AM-PAC), Patient Inquiry by Focus On
Therapeutic Outcomes, Inc. (FOTO), or OPTIMAL by Cedaron through the
American Physical Therapy Association; or, when one of these tools is
not used, they may use (a) functional assessment individual item and
summary scores from commercially available therapy outcomes
instruments, (b) functional assessment scores from tests and
measurements validated in the professional literature that are
appropriate for the condition/function being measured; or (c) other
measurable progress towards identified goals for functioning in the
home environment at the conclusion of the therapy episode of care. For
these reasons, we believe therapists will continue to use the
measurement tools they have used in the past to identify measureable
physical functional status even after we discontinue the claims-based
functional reporting requirements.
After consideration of the public comments, we are finalizing our
proposed changes to discontinue the functional reporting requirements
for outpatient therapy services furnished on or after January 1, 2019.
Specifically, we are removing the following regulatory requirements:
(1) Conditions of payment at Sec. Sec. 410.59(a)(4), 410.60(a)(4),
410.62(a)(4), and 410.105(d) that require claims for OT, PT, SLP, and
Comprehensive Outpatient Rehabilitation Facility (CORF) PT, OT, and SLP
services, respectively, to contain prescribed information on patient
functional limitations; and, (2) the functional reporting-related
phrase that requires the plan's goals to be consistent with functional
information on the claim at Sec. 410.61(c) for outpatient PT, OT, and
SLP services and at Sec. 410.105(c)(1)(ii) for the PT, OT, and SLP
services in CORFs.
In addition to amending these regulations, we are ending the
requirements for the reporting and documentation of functional
limitation G-codes (HCPCS codes G8978 through G8999 and G9158 through
G9186) and severity modifiers (in the range CH through CN) for
outpatient therapy claims with dates of service on and after January 1,
2019.
Instead of deleting the HCPCS G-codes effective for CY 2019 as
proposed, we are finalizing a modification of that proposal to retain
the set of 42 non-payable HCPCS G-codes until CY 2020 as this will
allow time for therapy providers and other private insurers who
currently use these HCPCS G-codes for purposes of functional reporting
to update their billing systems and policies. This will avoid a
situation where claims that inadvertently contain any of these G-codes
during CY 2019 can be processed, and are not unnecessarily returned or
rejected. The retention of HCPCS G-codes through CY 2019 will also
allow physical and occupational therapists to report six of these non-
payable HCPCS G-codes and the measures developed from them for purposes
of meeting the MIPS program requirements which are found in section
III.I.3. of this final rule.
We also intend to revise our manuals regarding the application of
the functional reporting requirements in our IOM, Pub. 100-02, Medicare
Benefits Policy Manual, Chapters 12 and 15, and Pub. 100-04, Medicare
Claims Processing Manual, Chapter 5.
4. Therapy KX Threshold Amounts
As noted above in this section, the KX modifier thresholds were
established through section 50202 of the Bipartisan Budget Act of 2018.
These KX modifier thresholds were formerly referred to as therapy caps
and are a permanent provision of the law, meaning that the statute does
not specify an end date. These per-beneficiary amounts under section
1833(g) of the Act (as amended by section 4541 of the Balanced Budget
Act of 1997) (Pub. L. 105-33, August 5, 1997) are updated each year
based on the MEI. Specifically, these amounts are calculated by
updating the previous year's amount by the MEI for the upcoming
calendar year and rounding to the nearest $10.00. Increasing the CY
2018 KX modifier threshold amount of $2,010 by the CY 2019 MEI of 1.5
percent and rounding to the nearest $10.00 results in a CY 2019 KX
threshold amount of $2,040 for PT and SLP services combined and $2,040
for OT services.
Along with the KX modifier thresholds, section 50202 of the
Bipartisan Budget Act of 2018 also added section 1833(g)(7)(B) of the
Act which retains the targeted medical review process, but at a lower
threshold amount of $3,000 (until CY 2028) as detailed previously in
this section. For CY 2018, the MR threshold is $3,000 for PT and SLP
services combined and $3,000 for OT services. Under the established
targeted review process, some, but not all claims exceeding the MR
threshold amount are subject to review. For information on the targeted
manual medical review process, go to https://www.cms.gov/Research-
Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-
Compliance-Programs/Medical-Review/TherapyCap.html.
CMS tracks each beneficiary's incurred expenses for therapy
services annually and counts them toward the KX modifier and MR
thresholds by applying the PFS rate for each service less any
applicable multiple procedure payment reduction (MPPR) amount for
services of CMS-designated ``always therapy'' services.
As required by section 1833(g)(6)(B) of the Act, added by section
603(b) of the American Taxpayer Relief Act of 2012 (ATRA) (Pub. L. 112-
240, January 2, 2013) and extended by subsequent legislation, including
section 50202 of the Bipartisan Budget Act of 2018, the PFS-rate
accrual process is applied to outpatient therapy services furnished by
critical access hospitals (CAHs) even though they may be paid on a cost
basis (effective January 1, 2014).
For Maryland hospitals paid under the Maryland All-Payer Model,
currently being tested under the authority of section 1115A of the Act
(effective January 1, 2016), we use the submitted charge amounts to
accrue to the KX modifier and MR thresholds.
After expenses incurred for the beneficiary's outpatient therapy
services for the year have exceeded one or both of the KX modifier
thresholds, therapy suppliers and providers use the KX modifier on
claims for subsequent medically necessary services. By using the KX
modifier, the therapist is attesting that the services above the KX
modifier thresholds are reasonable and necessary and that there is
documentation of medical necessity for the services in the
beneficiary's medical record. Claims for outpatient therapy services
that exceed the KX modifier thresholds but do not include the KX
modifier are denied.

M. Part B Drugs: Application of an Add-On Percentage for Certain
Wholesale Acquisition Cost (WAC)-Based Payments

Consistent with statutory provisions in section 1847A of the Act,
many current Medicare Fee-For-Service (FFS) payments for separately
payable drugs and biologicals furnished by providers and suppliers
include an add-on set at 6 percent of the volume-weighted average sales
price (ASP) or wholesale acquisition cost (WAC) for the drug or
biological (the ``6 percent add-on''). Although section 1847A of the
Act does not specifically state what the 6 percent add-on represents,
it is widely believed to include services associated with drug
acquisition that are not separately paid for, such as handling,
storage, other overhead, as well as additional mark-

[[Page 59662]]

ups in drug distribution channels. The 6 percent add-on described in
section 1847A of the Act has raised concerns because more revenue can
be generated from percentage-based add-on payments for expensive drugs,
and an opportunity to generate more revenue may create an incentive for
the use of more expensive drugs (MedPAC Report to the Congress:
Medicare and the Health Care Delivery System June 2015, https://
medpac.gov/docs/default-source/reports/june-2015-report-to-the-
congress-medicare-and-the-health-care-delivery-system.pdf, pages 65
through 72). Also, the Office of the Assistant Secretary for Planning
and Evaluation (ASPE) March 8, 2016, Issue Briefing pointed out that
administrative complexity and overhead costs are not exactly
proportional to the price of a drug (https://aspe.hhs.gov/pdf-report/
medicare-part-b-drugs-pricing-and-incentives). Thus, the suitability of
using a percentage of the volume-weighted ASP or WAC of the drug or
biological for an add-on payment may vary depending on the price of the
drug or how the payment rate has been determined.
Although the add-on percentage for drug payments made under section
1847A of the Act is typically applied to the ASP, a 6 percent add-on is
also applied to the WAC to determine the Part B drug payment allowances
in the following situations. First, for single source drugs, as
authorized in section 1847A(b)(4) of the Act, payment is made using the
lesser of ASP or WAC; and section 1847A(b)(1) of the Act requires that
a 6 percent add-on be applied regardless of whether WAC or ASP is less.
Second, for drugs and biologicals where the ASP during first quarter of
sales is unavailable, section 1847A(c)(4) of the Act allows the
Secretary to determine the payment amount for the drug or biological
based on the WAC or payment methodologies in effect on November 1,
2003. We note that this provision does not specify that an add-on
percentage be applied if WAC-based payment is used, nor is an add-on
percentage specified in the implementing regulations at Sec.
414.904(e)(4). The application of the add-on percentage to WAC-based
payments during a period where partial quarter ASP data was available
was discussed in the 2011 PFS final rule with comment (75 FR 73465
through 73466). Third, in situations where Medicare Administrative
Contractors (MACs) determine pricing for drugs that do not appear on
the ASP pricing files and for new drugs, WAC-based payment amounts may
also be used, as discussed in Chapter 17, Section 20.1.3 of the
Medicare Claims Processing Manual. This section of the manual describes
the use of a 6 percent add-on.
The incorporation of discounts in the determination of payment
amounts made for Part B drug varies. Most Part B drug payments are
based on the drug's or biological's ASP; as provided in section
1847A(c)(3) of the Act, the ASP is net of many discounts such as volume
discounts, prompt pay discounts, cash discounts, free goods that are
contingent on any purchase, chargebacks, and rebates (other than
rebates under Medicaid drug rebate program). In contrast, the WAC of a
drug or biological is defined in section 1847A(c)(6)(B) of the Act as
the manufacturer's list price for the drug or biological to wholesalers
or direct purchasers in the United States, not including prompt pay or
other discounts, rebates or reductions in price, for the most recent
month for which the information is available, as reported in wholesale
price guides or other publications of drug or biological pricing data.
Because the WAC does not include discounts, it typically exceeds ASP,
and the use of a WAC-based payment amount for the same drug results in
higher dollar payments than the use of an ASP-based payment amount.
Although discussions about the add-on tend to focus on ASP-based
payments (because ASP-based payments are more common than WAC-based
payments), the add-on for WAC-based payments has also been raised in
the June 2017 MedPAC Report to the Congress (https://www.medpac.gov/
docs/default-source/reports/jun17_reporttocongress_sec.pdf, pages 42
through 44). The MedPAC report focused on how the 2 quarter lag in
payments determined under section 1847A of the Act led to a situation
where undiscounted WAC-based payment amounts determined using
information from 2 quarters earlier were used to pay for drugs that
providers purchased at a discount. To determine the extent of the
discounts, MedPAC sampled new, high-expenditure Part B drugs and found
that these drugs' ASPs were generally lower than their WACs. Seven out
of the 8 drugs showed pricing declines from initial WAC to ASP one year
after being listed in the ASP pricing files with the remaining product
showing no change, which suggests purchasers received discounts that
WAC did not reflect. MedPAC further cited a 2014 OIG report (OIG,
Limitations in Manufacturer Reporting of Average Sales Price Data for
Part B Drugs, (OEI-12-13-00040), July 2014) to illustrate that there
may be differences between WAC and ASP in other instances in which CMS
utilizes WAC instead of ASP and noted that OIG found that ``WACs often
do not reflect actual market prices for drugs.'' MedPAC also
characterized Part B payments based on undiscounted list prices for
products that were available at a discount as excessive. The report
suggested that greater parity between ASP-based acquisition costs and
WAC-based payments for Part B drugs could be achieved and recommended
changing the 6 percent add-on for WAC-based payments to 3 percent. A 3
percent change was recommended based on statements made by industry,
MedPAC's analysis of new drug pricing, and OIG data. The report also
mentioned that discounts on WAC, such as prompt pay discounts, were
available soon after the drug went on the market.
In the case of a drug or biological during an initial sales period
in which data on the prices for sales for the drug or biological is not
sufficiently available from the manufacturer, section 1847A(c)(4) of
the Act permits the Secretary to make payments that are based on WAC.
In other words, although payments under this section may be based on
WAC, unlike section 1847A(b) of the Act (which specifies that certain
payments must be made with a 6 percent add-on), section 1847A(c)(4) of
the Act does not require that a particular add-on amount or percentage
be applied to partial quarter WAC-based pricing. Consistent with
section 1847A(c)(4) of the Act, we proposed that effective January 1,
2019, WAC based payments for Part B drugs made under section
1847A(c)(4) of the Act, utilize a 3 percent add-on in place of the 6
percent add-on that is currently being used. We proposed a 3 percent
add-on because this percentage is consistent with MedPAC's analysis and
recommendations discussed in the paragraph above and cited in its June
2017 Report to the Congress. Although other approaches for modifying
the add-on amount, such as a flat fee, or percentages that vary with
the cost of a drug, are possible, we proposed a fixed percentage in
order to be consistent with other provisions in section 1847A of the
Act that specify fixed add-on percentages of 6 percent (section
1847A(b) of the Act) or 3 percent (section 1847A(d)(3)(C) of the Act).
A fixed percentage is also administratively simple to implement and
administer, predictable, and easy for manufacturers, providers and the
public to understand.
We have also reviewed corresponding regulation text at Sec.
414.904(e)(4). To conform the regulation text more closely to the
statutory language at section

[[Page 59663]]

1847A(c)(4) of the Act, we also proposed to strike the word
``applicable'' from paragraph (e)(4) of Sec. 414.904. Section
1847A(c)(4) of the Act does not use the term ``applicable'' to describe
the payment methodologies in effect on November 1, 2003.
We also discussed changing the policy articulated in the Medicare
Claims Processing Manual that describes the application of the 6
percent add-on to payment determinations made by MACs for new drugs and
biologicals. Chapter 17 section 20.1.3 of the Claims Processing Manual
(https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/
Downloads/clm104c17.pdf) states that WAC-based payment limits for drugs
and biologicals that are produced or distributed under a new drug
application (or other new application) approved by the Food and Drug
Administration, and that are not included in the ASP Medicare Part B
Drug Pricing File or Not Otherwise Classified (NOC) Pricing File, are
based on 106 percent of WAC. Invoice-based pricing is used if the WAC
is not published. In the Hospital Outpatient Prospective Payment System
(OPPS) program, the payment allowance limit is 95 percent of the
published Average Wholesale Price (AWP). We discussed permitting MACs
to use an add-on percentage of up to 3 percent for WAC-based payments
for new drugs. MACs have longstanding authority to make payment
determinations when we do not publish a payment limit in our national
Part B drug pricing files and when a new drug becomes available. This
proposal intended to preserve consistency with our proposed national
pricing policy and would apply when MACs perform pricing
determinations, for example during the period when ASPs have not been
reported. The proposed policy would not alter OPPS payment limits;
however, the CY 2019 OPPS proposed rule (83 FR 37046) includes a
discussion about proposed changes to certain WAC-based drug payments
under the OPPS.
We note that the PFS rule proposals do not include WAC-based
payments for single source drugs under section 1847A(b) of the Act,
that is, where the statute specifies that the payment limit is 106
percent of the lesser of ASP or WAC.
We have stated in previous rulemaking (80 FR 71101) that it is
desirable to have fair reimbursement in a healthy marketplace that
encourages product development. We have also stated that we seek to
promote innovation to provide more options to patients and physicians,
and competition to drive prices down (82 FR 53183). These positions
have not changed. However, since 2011, concern about the impact of drug
pricing and spending on Part B drugs has continued to grow. From 2011
to 2016, Medicare Part B drug spending increased from $17.6 billion to
$28.0 billion, representing a compound annual growth rate of 9.8
percent, with per capita spending increasing 54 percent, from $532 to
$818 (Based on Spending and Enrollment Data from the CMS Office of
Enterprise Data and Analytics). These increases affect the spending by
Medicare and beneficiary out-of-pocket costs. In the context of these
concerns, we believe that implementation of these proposals would
improve Medicare payment rates by better aligning payments with drug
acquisition costs, especially for the growing number of drugs with high
annual spending and high launch prices where single doses can cost tens
or even hundreds of thousands of dollars. The proposals would also
decrease beneficiary cost sharing. A 3 percentage point reduction in
the total payment allowance will reduce a patient's 20 percent Medicare
Part B copayment--for a drug that costs many thousands of dollars per
dose, this can result in significant savings to an individual. The
proposed approach would help Medicare beneficiaries afford to pay for
new drugs by reducing out of pocket expenses and would help counteract
the effects of increasing launch prices for newly approved drugs and
biologicals. Finally, the proposals are consistent with recent MedPAC
recommendations.
The following is a summary of the comments we received on these
proposals.
Comment: Many commenters expressed concerns about the proposed add-
on reduction and its effect on providers. Many of these commenters
focused on the percentage portion of the add-on, stating that the
proposed lower add-on would result in payment at ASP + 1.35 percent
because of the sequester reduction.
Response: The Budget Control Act of 2011 (Pub. L. 112-25, enacted
August 2, 2011) requires mandatory across-the-board reductions in
Federal spending, also known as sequestration. The application of
sequestration (after the American Taxpayer Relief Act of 2012 (Pub. L.
112-240, enacted January 2, 2013) postponed sequestration for 2 months)
requires the reduction of Medicare payments by 2 percent for many
Medicare FFS claims with dates-of-service on or after April 1, 2013.
The proposed change to the add-on percentage does not include
reductions applied to Medicare payments under sequestration, as
sequestration is independent of Medicare payment policy. However, we
understand the concerns about the reduction to the add-on and the
effects of the sequester resulting in a situation where payment amounts
could be potentially insufficient to cover acquisition costs for
expensive drugs, such as for specialties like rheumatology, which
utilize a narrow range of drugs with similar prices, and for providers
who may not be able to acquire drugs below the ASP. The policy we
proposed would reduce the add-on for WAC-based payment to 3 percent; it
would be limited to new drugs and would not apply to the add-on to ASP-
based payment amounts. The 3 percent reduction is discussed in further
detail in the comment responses below.
Comment: A number of commenters stated that the 6 percent markup is
intended to account for specific costs, such as handling, storage and
other administrative expenses.
Response: Section 1847A of the Act does not specifically state what
the 6 percent add-on represents, and the accompanying Conference Report
to the Medicare Prescription Drug, Improvement, and Modernization Act
of 2003, which added section 1847A to the Act, similarly does not
discuss the purpose of the 6 percent add-on (see Conference Report on
H.R. 1, November 20, 2003). Although section 1847A of the Act does not
specifically state what the add-on represents, it is believed by many
that the 6 percent add on includes various activities associated with
drug acquisition that are not separately paid for, such as handling,
and storage, as well as additional costs, such as overhead and mark-ups
in drug distribution channels; however, there is no consensus on the
intent of the add-on (MedPAC Report to the Congress: Medicare and the
Health Care Delivery System June 2016, https://www.medpac.gov/docs/
default-source/reports/june-2016-report-to-the-congress-medicare-and-
the-health-care-delivery-system.pdf?sfvrsn=0, page 127).
Comment: Commenters expressed concerns that a payment reduction of
3 percent would affect physicians and limit their utilization of new
drugs, particularly in practices where margins are small, such as rural
practices and small practices. Commenters were concerned that payments
for drugs under the proposed reduction would not cover overhead (such
as costs to order and store drugs, and rising costs for compliance with
standards for the preparation of sterile drugs for administration to a
patient), and other

[[Page 59664]]

costs (such as taxes and markups from intermediaries like wholesalers).
Commenters stated that such payment reductions would require physicians
to take a loss on new drugs or would prevent physicians from providing
new drugs in the office. Several commenters disagreed that the markup
incentivizes the use of more expensive drugs, while others agreed that
financial incentives to use Part B drugs exist, particularly in the
case of expensive drugs. One commenter noted that Part B includes some
of the most expensive drugs available in the United States. Several
commenters also noted that MedPAC data suggested that WAC-based
payments with a 3 percent add-on could sometimes be less than ASP based
payments with a 6 percent add-on.
Response: The payment methodology in section 1847A of the Act was
authorized by the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (Pub. L. 108-173, enacted on December 8,
2003). Since then, drug prices have increased significantly, sometimes
reaching into the tens and even hundreds of thousands of dollars for a
single dose of a drug. We agree with commenters that Part B includes
payments for very expensive drugs, and at least one GAO study has
pointed out that the most new Part B drugs are costly and tend to be
biologicals (Medicare Part B: Expenditures for New Drugs Concentrated
among a Few Drugs, and Most Were Costly for Beneficiaries. (GAO
Publication No. GAO-16-12; https://www.gao.gov/assets/680/673304.pdf)).
As stated in the previous comment response, the purpose of the 6
percent add-on is not clear, however, we are interested in striking a
balance between concerns about providers' overhead costs and concerns
about addressing financial incentives that may lead to excessive drug
use.
If the add-on is intended to account for administrative complexity,
handling, storage and other overhead costs, these factors are not
considered to be exactly proportional to current drug prices (https://
aspe.hhs.gov/pdf-report/medicare-part-b-drugs-pricing-and-incentives).
The application of the 6 percent add-on results in large dollar value
payments for new drugs that are proportional only to the price of the
drug. Further, the application of a 6 percent add-on to an undiscounted
price like WAC, rather than a market-based price, can result in
additional differences between acquisition cost and payment. This
difference can become significant, particularly for higher cost drugs
where the 6 percent add-on can be hundreds or even thousands of
dollars, and can become even more substantial when WAC exceeds ASP or
acquisition cost. We are concerned that as drug prices continue to
increase, the add-on is continuing to evolve into a financial incentive
that is not consistent with the appropriate use of new Part B drugs.
Many new drugs are expensive; single doses may cost thousands of
dollars. Six percent add-ons for expensive drugs may be excessive
relative to factors such as the cost to acquire a drug, handling and
storage, and other overhead costs. We believe that overhead costs for
most new drugs and biologicals are generally comparable to the overhead
costs for most other injectable Part B drugs. For example, many heavily
utilized injectable Part B drugs and biologicals, including new
products, appear to be readily available since they are listed in drug
wholesalers' catalogues. With certain exceptions, such as biologicals
made from autologous cells, prescribing information indicates that many
injectable Part B drugs and biologicals are stable under refrigeration
or room temperature and do not require highly specialized storage or
shipping conditions. We also note that many newer injectable drugs are
also produced in ready to use liquid form, thus additional
reconstitution and complicated dose preparation steps are not
necessary. For many newer injectable products that were added to the
ASP drug files in 2018, prescribing information indicates that dose
preparation is comparable to many other sterile injectables and
consists of drawing up the drug into a syringe using aseptic technique,
and sometimes diluting the dose in a small volume bag of intravenous
fluid. Some of the newer products are available in ready to use
syringes which are administered directly to the patient with no special
preparation steps.
We believe that the 3 percent reduction will help encourage the
appropriate utilization of new drugs by lessening the financial
incentive to overutilize drugs during their initial period of sales. We
will discuss the percentage in more detail in the next comment
response, but in general we believe that this reduction will not reduce
margins for Part B drugs to an extent that would significantly and
negatively affect providers, for several reasons. First, the overhead
for many new drugs and biologicals is not likely to be significantly
higher than the overhead for existing Part B injectable drugs (as
discussed in the paragraph above). Second, the add-on is based on an
undiscounted list price that is usually higher than market prices, and
many new drugs and biologicals are costly. When the add-on is based on
an undiscounted list price, this may contribute to potentially
excessive add-on payments, particularly for expensive new drugs. As the
WAC of a drug increases, so does the dollar value of the add-on, and
this increase is not tied to any other factors, such actual market
cost, administrative complexity of ordering the drug, or additional
overhead costs, for example. The add-on for a costly drug can add
significantly to the payment for a drug; a 6 percent add-on for a
$5,000 dose of a drug is $300, while the 6 percent add-on for a $10,000
dose is $600. Third, the duration of the reduction to WAC-based
payments for new drugs would be brief, applying only during an initial
period as stipulated in section 1847A(c)(4) of the Act, where ASP data
for drugs or biologicals (including biosimilars) is not sufficiently
available to determine an ASP-based payment. Fourth, based on recent
additions to the ASP drug pricing files, the change would affect only a
small number of drugs each year. Typically, several drugs are added to
the ASP Drug Pricing files each quarter, and not all of those drugs are
priced based on WAC; some are added to the pricing files after the
initial period of sales and are paid based on ASP. For these reasons,
we are not persuaded that the reduction of the add-on for new drugs
would have significant impact on margins for most physicians or other
providers, including small and rural practices.
While some WAC based payments for new drugs could be less than ASP-
based payments, the WAC exceeds the ASP for most new drugs entering the
market. Our approach using a percentage of the WAC-based amount
provides an administratively simple and straightforward solution for
new Part B drugs.
We reiterate that our proposal did not include payments for single
source drugs under section 1847A(b)(4) of the Act, where payment is
made using the lesser of ASP or WAC. (This methodology applies after
CMS receives ASP data for the drug.) Section 1847A(b)(1) of the Act
requires that a 6 percent add-on be applied regardless of whether WAC
or ASP is less; legislation would be required to change the percentage
of the add-on that is specified in this provision.
Comment: Several commenters stated that the MedPAC analysis was too
limited and did not support a 3 percent add-on. Some suggested that
delaying the add-on reduction and conducting more research was a
reasonable alternative. Several commenters noted that manufacturers
could increase WAC in response to CMS' change in policy.

[[Page 59665]]

Response: The MedPAC analysis encompassed drugs with ASP data after
2005 that were in the top 20 highest expenditures in 2014. The analysis
indicated that ASP was lower than WAC soon after a drug is marketed; a
range of percentages from 0.0 to -2.7 percent was reported. We believe
that the 0.0 to -2.7 percent range may underestimate the average
difference between WAC and ASP because the MedPAC's group of 8 drugs
did not encompass codes where WAC substantially exceeded ASP, such as
certain biosimilars. We also note that this analysis of drugs was not
the only factor for MedPAC's recommendation of a 3 percent add-on. The
report stated that the recommendation for 3 percent change was also
based on industry statements regarding prompt-pay discounts, and
previous OIG research (https://www.medpac.gov/docs/default-source/
reports/jun17_reporttocongress_sec.pdf, pages 43, 44, 52, and 68). For
these reasons, we disagree with commenters that the MedPAC analysis was
too limited.
Although the number of new drugs that appear on the ASP Drug
Pricing Files with a WAC-based payment amount is limited, we stated in
the proposed rule (83 FR 36047) that the average difference between WAC
and ASP-based payment limits for a group of 3 recently approved drugs
and biologicals that appeared on the ASP Drug Pricing Files (including
one biosimilar biological product) was 9.0 percent. Excluding the
biosimilar biological product results in a difference of 3.5 percent.
These findings agree with the MedPAC's analysis and support the use of
a 3 percent reduction to WAC-based payments for new drugs. Given the
limited application of this policy change, the sources used by the
MedPAC (which include industry statements), and our internal review, we
do not believe that additional study or delay is necessary.
We are aware that ASP-based payments may exceed payments based on
WAC if the percentage for the WAC add-on is smaller than the ASP add-
on. The proposal for this policy change was limited to payments under
section 1847A(c)(4) of the Act. We do not have authority to change the
add-on for WAC based payments made under section 1847A(b)(4) of the Act
or payments based on the ASP, and we have not addressed such payments
in this rule. We believe that implementation of this relatively minor
change without further delay is a positive step toward addressing high
drug prices, including list prices. We acknowledge that manufacturers
may increase Part B drug prices and that price increases could apply to
both list prices like WAC and market-based prices, such as ASP. Section
1847A of the Act does not provide us with authority to addresses most
increases for Part B drug prices (we have limited authority to
substitute AMP-based prices for ASP, and authority to use alternative
prices in response to certain public health emergencies). Price
increases from manufacturers and other sources that add to high drug
costs will be considered as we continue our work to address concerns
about high drug prices.
Comment: Several commenters pointed out that the proposal does not
address prices after the initial period of drug marketing, and that the
MedPAC's recommendations about reducing the WAC payment add-on
percentage were part of several proposals about Part B drug pricing.
Several commenters also stated that the proposal to decrease WAC
payments is not consistent with the President's goal to decrease list
prices for drugs.
Response: This proposal encompassed a change in policy that could
be implemented in a relatively short time period and without additional
legislation. The proposal is also consistent with the 2019 President's
Budget's proposal. Language in the Major Savings and Reforms document
states that if discounts are available for new Part B drugs, the use of
WAC-based payments results in Medicare paying more than under ASP-based
pricing (https://www.whitehouse.gov/wp-content/uploads/2018/02/msar-
fy2019.pdf, page 150). The Budget proposal also contained other agenda
items that are similar to the MedPAC's 2017 recommendations and would
require legislation to implement. Such legislative changes, including
authority to limit or to otherwise regulate WAC or other list prices
for drugs are outside the scope of this rule; however, other
information pertaining to drug pricing will be made public as it is
developed. We also note that the use of list prices to determine the
payment for Part B drugs is limited and the number of drugs paid using
list prices is small. As we continue to work on other approaches to
address high drug prices, we plan to monitor Part B drug prices and
changes to drug costs that may be related to this policy.
Comment: Many commenters focused on potential negative effects on
patients, and expressed concerns that a negative impact on physicians
would lead to fewer offices providing new drugs, leading to shifts to
higher cost care settings like hospital outpatient departments, and
ultimately leading to higher cost sharing payments. A few commenters
stated that direct reductions in cost sharing (that is, the amount of
money paid by a patient) would be minimal because secondary insurance
(like Medigap) or alternative sources of payment are typically
available and pay for much of Part B drug cost sharing.
In contrast, several commenters agreed that cost sharing could
drop, though the effect would be transient (limited to the early phase
of a drug's marketing). However, these commenters generally agree that
the CMS proposal was a step in the right direction for addressing the
high cost of drugs.
Response: Overall, as discussed in an earlier comment response, we
believe that the scope of these changes is modest, will affect few
drugs, and will exert a brief effect on Part B drug payment, applying
only during the initial quarters when a new drug enters the market. As
stated earlier in this section, the overhead for many new drugs and
biologicals is not likely to be significantly higher than the overhead
for existing Part B injectable drugs, the add-on is based on an
undiscounted list price that tends to be higher than market prices, and
many new drugs and biologicals are expensive, thus we do not expect a
significant effect on providers' margins. Because we do not anticipate
a significant or prolonged effect on providers' margins, we also
disagree with the position that physicians' offices will be reluctant
to administer new drugs and that this reduction to the add-on will
negatively affect beneficiaries access to drugs at offices resulting in
shifting patients to more expensive settings. As we stated in the
proposed rule (83 FR 36047), we believe that the reduction in the WAC-
based payment add-on can positively impact individual beneficiaries in
situations where they encounter out of pocket cost sharing payments for
new and expensive drugs entering the market. We acknowledge that many
beneficiaries that receive Part B drugs have supplementary insurance,
but for beneficiaries that do not have supplementary insurance, this
policy will help reduce out of pocket costs. We would like to reiterate
that single doses of new drugs may costs thousands of dollars or more
and a 3 percent reduction in the add-on percentage can result in
meaningful savings to individual patients. We agree with commenters
that a change to the add-on for new drugs is a step in the right
direction for addressing the high cost of drugs. Overall, this policy
will also provide a modest reduction in spending

[[Page 59666]]

for drugs by lowering the total payment for new Part B drugs.
After considering the comments submitted in response to our
proposal, consistent with section 1847A(c)(4) of the Act, we are
finalizing our proposal to reduce the add-on percentage for WAC based
payments for new drugs. Effective January 1, 2019, WAC based payments
for new Part B drugs made under section 1847A(c)(4) of the Act, will
utilize a 3 percent add-on in place of the 6 percent add-on that is
currently being used. Our final policy is consistent with the
President's Budget and affects an area where we have flexibility to
make a change through regulation. The percentage reduction is also
consistent with the MedPAC's analysis and recommendations discussed in
this section and cited in its June 2017 Report to the Congress. A fixed
percentage is also administratively simple to implement and administer,
is predictable, and is easy for manufacturers, providers and the public
to understand. We believe that the 3 percent reduction to the add-on
for WAC-based payments will create greater parity overall between WAC
and ASP for new drugs, biologicals and biosimilars and continue to
encourage appropriate utilization of drugs. We are not persuaded that
this modest and brief reduction in payments will impair access to new
drugs or shift patient care to other settings.
This change does not apply to single source drugs or biologicals
paid under section 1847A(b)(4) of the Act where payment is made using
the lesser of ASP or WAC; section 1847A(b)(1) of the Act requires that
a 6 percent add-on be applied regardless of whether WAC or ASP is less.
Comment: We received no specific comments on the proposal to
conform the regulation text more closely to the statutory language at
section 1847A(c)(4) of the Act. We proposed striking ``applicable''
from regulation text at Sec. 414.904(e)(4).
Response: We are finalizing this change as proposed and revising
regulation text at Sec. 414.904(e)(4) so that the language is more
consistent with the statute.
Comment: Several commenters opposed our intent to change the policy
articulated in Chapter 17 of the Medicare Claims Processing Manual that
describes the application of the 6 percent add-on to payment
determinations made by MACs for new drugs and biologicals to reflect
our proposal, if finalized. Commenters opposed the Manual changes for
the same general reasons that they opposed the proposal to change the
WAC-based add-on percentage under section 1847A(c)(4) of the Act.
Commenters were also concerned about whether the use of an add-on that
could be less than 3 percent would create additional financial stress
for providers and whether the manual changes would apply to any WAC-
based payment. The commenters also questioned whether CMS has authority
to make these changes.
Response: The discussion about changes to Chapter 17 of the
Medicare Claims Processing Manual was intended to provide notice of a
potential corresponding subregulatory change to align with our
regulatory policy if the provision to change the add-on percentage was
finalized. Because we finalized the proposal to reduce the WAC-based
payment add-on for payments made under the authority in section
1847A(c)(4) of the Act, in the near future we plan to issue Manual
instructions that will address contractor pricing for new Part B drugs.
We are clarifying that changes to payments for WAC based drugs
discussed in this rule apply only to new drugs and only during the time
period while an ASP-based payment limit is not available. This time
period begins when a drug is marketed and no ASP data is available for
the manufacturer to report to us and ends at the end of the partial
quarter pricing period when partial quarter ASP data becomes available
to us. We will provide additional guidance or program instructions as
appropriate.
The variable percentage that we plan to utilize in the manual, that
is, the use of an add-on that is up to 3 percent, addresses the wide
range of Part B drug prices. As discussed earlier in this section, the
6 percent add-on payment amount for very expensive drugs can result in
very high add-on payments. For example, 6 percent of a $30,000 drug is
$1800, while 6 percent of $300,000 is $18,000. We are aware of recently
approved Part B drugs that have per dose price points up to several
hundred thousand dollars. Our intent is to address the add-on payment
that is associated with new drugs before national pricing and
potentially other related policies, such as coverage, are developed.
Our approach is consistent with provisions in section 1847A(c)(4) of
the Act, which does not set a specific percentage for the add-on for
drugs where ASP is not available. We also note that section 1847A(c)(5)
of the Act provides authority to issue program instructions to
implement section 1847A of the Act.
Comment: One commenter expressed concern about the lack of lead
time for the changes in drug payment policy.
Response: Notice and comment rulemaking associated with Part B drug
payments made under the methodology in section 1847A of the Act
typically appears in the annual PFS Rule. Finalized changes to the add-
on percentage will not be implemented until January 1, 2019. We believe
that using the established process for notice and comment rulemaking is
acceptable and provides sufficient notice for the public. As stated
earlier in this section, we believe that this change is modest, and its
effects on payment for individual drugs will be brief. Further, this
change does not require any billing or claims processing changes.
In addition to the comments on the Part B drug add-on percentage
for certain drugs discussed previously in this section, we received
comments that suggested other alterations to the payment methodology
under section 1847A of the Act. These suggestions include replacing a
percentage add-on with a flat fee, changes to WAC-based pricing for
drugs that are not new, changing payments for drugs that are not paid
for under section 1847A of the Act (such as radiopharmaceuticals used
in the office), the use of competitive acquisition or value-based
payment for Part B drugs, making direct pricing interventions with
manufacturers, requiring greater transparency for drug pricing, and
educating (or otherwise influencing) providers about Part B drug
prescribing. We also received comments pertaining to ASP reporting by
manufacturers. Several commenters also questioned the authority for
Part B drug payment reductions associated with the sequester. Comments
on these issues are also outside the scope of this rule. Therefore,
these comments are not addressed in this final rule.

N. Potential Model for Radiation Therapy

Section 3(a) of the Patient Access and Medicare Protection Act
(PAMPA) (Pub. L. 114-115, enacted December 28, 2015) revised section
1848 of the Act so that, for the fee schedule established under section
1848(b) of the Act in 2017 and 2018, we must apply the same code
definitions and work RVUs under section 1848(c)(2)(C)(ii) of the Act,
and the same direct inputs for the PE RVUs for radiation treatment
delivery and related imaging services under section 1848(c)(2)(C)(ii)
of the Act as those definitions, units, and inputs for such services
for the fee schedule established for services furnished in 2016.
Section 51009 of the Bipartisan Budget Act of

[[Page 59667]]

2018 extended these policies through 2019. Furthermore, section 3(b) of
the PAMPA requires the Secretary of Health and Human Services to submit
to Congress a report on the development of an episodic APM for payment
under the Medicare program under title XVIII of the Act for radiation
therapy (RT) services furnished in non-facility settings (``Report to
Congress''). In the Report to Congress \7\ delivered in November 2017,
we discussed the current status of RT services and payment, and
reviewed model design considerations for a potential APM for RT
services.
---------------------------------------------------------------------------

\7\ Report to Congress: Episodic Alternative Payment Model for
Radiation Therapy Services. https://innovation.cms.gov/Files/
reports/radiationtherapy-apm-rtc.pdf.
---------------------------------------------------------------------------

For the Report to Congress, the CMS Center for Medicare and
Medicaid Innovation (Innovation Center) conducted an environmental scan
of current evidence, as well as held a public listening session
followed by an opportunity for RT stakeholders to submit written
comments about a potential APM. A review of the applicable evidence in
the Report to Congress demonstrated that episode payment models can be
a tool for improving care and reducing expenditures. We believe that
radiation oncology is a promising area of health care for bundled
payments, in part, based on the findings in the Report to Congress. The
CMS Innovation Center has and will continue to use public information
regarding commercial initiatives, as well as stakeholder feedback to
help inform the development, implementation, and refinement of design
and testing of a potential model that tests payment for RT services
under the authority of section 1115A of the Act.

III. Other Provisions of the Proposed Rule

A. Clinical Laboratory Fee Schedule

1. Background
Prior to January 1, 2018, Medicare paid for clinical diagnostic
laboratory tests (CDLTs) on the Clinical Laboratory Fee Schedule (CLFS)
under sections 1832, 1833(a), (b), and (h), and 1861 of the Social
Security Act (the Act). Under the previous methodology, CDLTs were paid
based on the lesser of: (1) The amount billed; (2) the local fee
schedule amount established by the Medicare Administrative Contractor
(MAC); or (3) a national limitation amount (NLA), which is a percentage
of the median of all the local fee schedule amounts (or 100 percent of
the median for new tests furnished on or after January 1, 2001). In
practice, most tests were paid at the NLA. Under the previous system,
the CLFS amounts were updated for inflation based on the percentage
change in the Consumer Price Index for All Urban Consumers (CPI-U), and
reduced by a multi-factor productivity adjustment and other statutory
adjustments, but were not otherwise updated or changed.
Section 1834A of the Act, as established by section 216(a) of the
Protecting Access to Medicare Act of 2014 (PAMA), required significant
changes to how Medicare pays for CDLTs under the CLFS. The CLFS final
rule, entitled Medicare Clinical Diagnostic Laboratory Tests Payment
System (CLFS final rule), published in the Federal Register on June 23,
2016, implemented section 1834A of the Act. Under the CLFS final rule,
``reporting entities'' must report to CMS during a ``data reporting
period'' ``applicable information'' collected during a ``data
collection period'' for their component ``applicable laboratories.''
Applicable information is defined at Sec. 414.502 as, with respect to
each CDLT for a data collection period: Each private payor rate for
which final payment has been made during the data collection period;
the associated volume of tests performed corresponding to each private
payor rate; and the specific Healthcare Common Procedure Coding System
(HCPCS) code associated with the test. Applicable information does not
include information about a test for which payment is made on a
capitated basis. An applicable laboratory is defined at Sec. 414.502,
in part, as an entity that is a laboratory (as defined under the
Clinical Laboratory Improvement Amendments (CLIA) definition at Sec.
493.2) that bills Medicare Part B under its own National Provider
Identifier (NPI). In addition, an applicable laboratory is an entity
that receives more than 50 percent of its Medicare revenues during a
data collection period from the CLFS and/or the Physician Fee Schedule
(PFS). We refer to this component of the applicable laboratory
definition as the ``majority of Medicare revenues threshold.'' The
definition of applicable laboratory also includes a ``low expenditure
threshold'' component which requires an entity to receive at least
$12,500 of its Medicare revenues from the CLFS for its CDLTs that are
not advanced diagnostic laboratory tests (ADLTs).
The first data collection period, for which applicable information
was collected, occurred from January 1, 2016 through June 30, 2016. The
first data reporting period, during which reporting entities reported
applicable information to CMS, occurred January 1, 2017 through March
31, 2017. On March 30, 2017, we announced a 60-day enforcement
discretion period of the assessment of civil monetary penalties (CMPs)
for reporting entities that failed to report applicable information.
Additional information about the 60-day enforcement discretion period
is available on the CMS website at https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Downloads/2017-
March-Announcement.pdf.
In general, the payment amount for each CDLT on the CLFS furnished
beginning January 1, 2018, is based on the applicable information
collected during the data collection period and reported to us during
the data reporting period, and is equal to the weighted median of the
private payor rates for the test. The weighted median is calculated by
arraying the distribution of all private payor rates, weighted by the
volume for each payor and each laboratory. The payment amounts
established under the CLFS are not subject to any other adjustment,
such as geographic, budget neutrality, or annual update, as required by
section 1834A(b)(4)(B) of the Act. Additionally, section 1834A(b)(3) of
the Act, implemented at Sec. 414.507(d), provides a phase-in of
payment reductions, limiting the amounts the CLFS rates for each CDLT
(that is not a new ADLT or new CDLT) can be reduced as compared to the
payment rates for the preceding year. For the first 3 years after
implementation (CY 2018 through CY 2020), the reduction cannot be more
than 10 percent per year, and for the next 3 years (CY 2021 through CY
2023), the reduction cannot be more than 15 percent per year. For most
CDLTs, the data collection period, data reporting period, and payment
rate update occur every 3 years. As such, the next data collection
period for most CDLTs will be January 1, 2019 through June 30, 2019,
and the next data reporting period will be January 1, 2020 through
March 31, 2020, with the next update to CLFS occurring on January 1,
2021. Additional information on the private payor rate-based CLFS is
detailed in the CLFS final rule (81 FR 41036 through 41101).
2. Recent Stakeholder Feedback
As we discussed in the CY 2019 PFS proposed rule (83 FR 35856),
after the initial data collection and data reporting periods, we
received feedback on a range of topics related to the private payor
rate-based CLFS. Some commenters expressed concern that the

[[Page 59668]]

CY 2018 CLFS payments rates are based on applicable information from
only a relatively small number of laboratories. Some commenters stated
that, because most hospital-based laboratories were not applicable
laboratories, and therefore, did not report applicable information
during the initial data reporting period, the CY 2018 CLFS payment
rates do not reflect their information and are inaccurate. Other
commenters were concerned that the low expenditure threshold excluded
most physician office laboratories and many small independent
laboratories from reporting applicable information.
We noted in the proposed rule that, in determining payment rates
under the private payor rate-based CLFS, one of our objectives is to
obtain as much applicable information as possible from the broadest
possible representation of the national laboratory market on which to
base CLFS payment amounts, for example, from independent laboratories,
hospital outreach laboratories, and physician office laboratories,
without imposing undue burden on those entities. As we noted throughout
the CLFS final rule, we believe it is important to achieve a balance
between collecting sufficient data to calculate a weighted median that
appropriately reflects the private market rate for a CDLT, and
minimizing the reporting burden for entities. In response to this
feedback and in the interest of facilitating our goal, we proposed a
change to the Medicare CLFS for CY 2019 in section III.A. of the CY
2019 PFS proposed rule. We stated that we believe this proposal may
result in more data being used on which to base CLFS payment rates.
In addition to this proposal, we solicited public comments on other
approaches that have been requested by some stakeholders who suggested
that such approaches would result in CMS receiving even more applicable
information to use in establishing CLFS payment rates. The approaches
include revising the definition of applicable laboratory and changing
the low expenditure threshold. These topics are discussed in this
section.
3. Change to the Majority of Medicare Revenues Threshold in Definition
of Applicable Laboratory
In order for a laboratory to meet the majority of Medicare revenues
threshold, section 1834A(a)(2) of the Act requires that, ``with respect
to its revenues under this title, a majority of such revenues are
from'' the CLFS and the PFS in a data collection period. In the CLFS
final rule, we stated that ``revenues under this title'' are payments
received from the Medicare program, which includes fee-for-service
payments under Medicare Parts A and B, as well as Medicare Advantage
(MA) payments under Medicare Part C, and prescription drug payments
under Medicare Part D, and any associated Medicare beneficiary
deductible or coinsurance amounts for Medicare services furnished
during the data collection period (81 FR 41043). This total Medicare
revenues amount (the denominator in the majority of Medicare revenues
threshold calculation) is compared to the total of Medicare revenues
received from the CLFS and/or PFS (the numerator in the majority of
Medicare revenues threshold calculation). If the numerator is greater
than 50 percent of the denominator for a data collection period, the
entity has met the majority of Medicare revenues threshold criterion.
We reflected that requirement in Sec. 414.502 in the third paragraph
of the definition of applicable laboratory.
As we explained in the CY 2019 PFS proposed rule, we have
considered that our current interpretation of total Medicare revenues
may have the effect of excluding laboratories that furnish Medicare
services to a significant number of beneficiaries enrolled in MA plans
under Medicare Part C from meeting the majority of Medicare revenues
threshold criterion, and therefore, from qualifying as applicable
laboratories. For instance, if a laboratory has a significant enough
Part C component so that it is receiving greater than 50 percent of its
total Medicare revenues from MA payments under Part C, it would not
meet the majority of Medicare revenues threshold because its revenues
derived from the CLFS and/or PFS would not constitute a majority of its
total Medicare revenues. We stated that we believe if we were to
exclude MA plan revenues from total Medicare revenues, more
laboratories of all types may meet the majority of Medicare revenues
threshold, and therefore, the definition of applicable laboratory,
because it would have the effect of decreasing the amount of total
Medicare revenues and increase the likelihood that a laboratory's CLFS
and PFS revenues would constitute a majority of its Medicare revenues.
We stated in the proposed rule that we believe section 1834A of the
Act permits an interpretation that MA plan payments to laboratories not
be included in the total Medicare revenues component of the majority of
Medicare revenues threshold calculation. Rather, MA plan payments to
laboratories can be considered to only be private payor payments under
the CLFS. We emphasized in the CY 2019 PFS proposed rule that this
characterization of MA plan payments is limited to only the CLFS for
purposes of defining applicable laboratory. Whether MA plan payments to
laboratories or other entities are considered Medicare ``revenues'' or
``private payor payments'' in other contexts in the Medicare program is
not relevant to our proposal, and our characterization of MA plan
payments as private payor payments for purposes of the CLFS has no
bearing on any aspect of the Medicare program other than the CLFS.
As noted above, we defined total Medicare revenues for purposes of
the majority of Medicare revenues threshold calculation to include fee-
for-service payments under Medicare Parts A and B, as well as MA
payments under Medicare Part C, prescription drug payments under
Medicare Part D, and any associated Medicare beneficiary deductible or
coinsurance amounts for Medicare services furnished during the data
collection period. However, section 1834A(a)(8) of the Act, which
defines the term ``private payor,'' identifies at section
1834A(a)(8)(B) a ``Medicare Advantage plan under Part C'' as a type of
private payor. Under the private payor rate-based CLFS, CLFS payment
amounts are based on private payor rates that are reported to CMS.
Accordingly, an applicable laboratory that receives MA plan payments is
to consider those MA plan payments in identifying its applicable
information, which must be reported to CMS. We explained in the
proposed rule that we believe it is more logical to not consider MA
plan payments under Part C to be both Medicare revenues for determining
applicable laboratory status and private payor rates for purposes of
reporting applicable information. Congress contemplated that applicable
laboratories would furnish MA services, as reflected in the requirement
that private payor rates must be reported for MA services. However,
under our current definition of applicable laboratory, laboratories
that furnish MA services, particularly those that furnish a significant
amount, are less likely to meet the majority of Medicare revenues
threshold, which means they would be less likely to qualify as
applicable laboratories, and as a result, to report private payor rates
for MA services.
Therefore, we stated in the proposed rule that after further review
and consideration of the new private payor rate-based CLFS, we believe
it is appropriate to include MA plan revenues as only private payor
payments rather than both Medicare revenues, for the purpose of

[[Page 59669]]

determining applicable laboratory status, and private payor payments,
for the purpose of specifying what is applicable information. Such a
change would have the effect of eliminating the laboratory revenue
generated from a laboratory's Part C-enrolled patient population as a
factor in determining whether a majority of the laboratory's Medicare
revenues are comprised of services paid under the CLFS or PFS. We noted
that we believe this change would permit a laboratory with a
significant Medicare Part C revenue component to be more likely to meet
the majority of Medicare revenues threshold and qualify as an
applicable laboratory. In other words, MA payments are currently
included as total Medicare revenues (the denominator). In order to meet
the majority of Medicare revenues threshold, the statute requires a
laboratory to receive the majority of its Medicare revenues from the
CLFS and or PFS. If MA plan payments were excluded from the total
Medicare revenues calculation, the denominator amount would decrease.
If the denominator amount decreases, the likelihood increases that a
laboratory would qualify as an applicable laboratory. Therefore, we
stated that we believe this proposal responds directly to stakeholders'
concerns regarding the number of laboratories for which applicable
information must be reported because a broader representation of the
laboratory industry may qualify as applicable laboratories, which means
we would receive more applicable information to use in setting CLFS
payment rates.
For these reasons, we proposed that MA plan payments under Part C
would not be considered Medicare revenues for purposes of the
applicable laboratory definition. We noted in the CY 2019 PFS proposed
rule that if finalized, we would revise paragraph (3) of the definition
of applicable laboratory at Sec. 414.502 accordingly. We reiterated
that not characterizing MA plan payments under Medicare Part C as
Medicare revenues would be limited to the definition of applicable
laboratory under the CLFS, and would not affect, reflect on, or
otherwise have any bearing on any other aspect of the Medicare program.
In an effort to provide stakeholders a better understanding of the
potential reporting burden that may result from this proposal, we
provided a summary of the distribution of data reporting that occurred
for the first data reporting period. We explained that if we were to
finalize the proposed change to the majority of Medicare revenues
threshold component of the definition of applicable laboratory,
additional laboratories of all types serving a significant population
of beneficiaries enrolled in Medicare Part C could potentially qualify
as applicable laboratories, in which case their data would be reported
to us. As discussed in the proposed rule, we received over 4.9 million
records from 1,942 applicable laboratories for the initial data
reporting period, which we used to set CY 2018 CLFS rates. Additional
analysis shows that the average number of records reported for an
applicable laboratory was 2,573. The largest number of records reported
for an applicable laboratory was 457,585 while the smallest amount was
1 record. A summary of the distribution of reported records from the
first data collection period is illustrated in the Table 25.

Table 25--Summary of Records Reported for First Data Reporting Period
[By applicable laboratory]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Percentile distribution of records
Total records Average Min records Max records -------------------------------------------------
records 10th 25th 50th 75th 90th
--------------------------------------------------------------------------------------------------------------------------------------------------------
4,995,877................................................... 2,573 1 457,585 23 79 294 1,345 4,884
--------------------------------------------------------------------------------------------------------------------------------------------------------

Assuming a similar distribution of data reporting for the next data
reporting period, the mid-point of reported records for an applicable
laboratory would be approximately 300 (50th percentile for the first
data reporting period was 294). However, as illustrated in Table 25,
the number of records reported varies greatly, depending on the volume
of services performed by a given laboratory. Laboratories with larger
test volumes, for instance at the 90th percentile, should expect to
report more records as compared to the midpoint used for this analysis.
Likewise, laboratories with smaller test volume, for instance at the
10th percentile, should expect to report fewer records as compared to
the midpoint.
The following is a summary of the comments we received and our
responses to the comments regarding our proposal to modify the
definition of applicable laboratory to exclude MA plan payments under
Part C as Medicare revenues.
Comment: Many commenters supported CMS' proposal to exclude MA plan
payments under Part C from total Medicare revenues and agreed it would
help achieve CMS' goal of increasing the number of laboratories
reporting applicable information. They stated that by excluding MA plan
payments from total Medicare revenues, the denominator of the majority
of Medicare revenues threshold, more laboratories of all types with a
significant share of revenues from Medicare Part C would be more likely
to qualify as an applicable laboratory and report applicable
information to CMS. They also agreed that removal of MA plan payments
from total Medicare revenues is consistent with the statute, which
defines MA plans as a private payor, and therefore will help enable
more laboratories to qualify as applicable laboratories. The commenters
that supported excluding MA plan payments under Part C from total
Medicare revenues urged CMS to finalize the proposal. However, some
stakeholders objected to CMS' proposal because it would result in
administrative reporting burden for additional laboratories without
having a perceptible impact on CLFS rates (because the largest
laboratories with the highest test volumes will continue to dominate
the weighted median of private payor rates). They stated that
increasing the number of laboratories qualifying for applicable
laboratory status and imposing additional data reporting burden, with
no perceptible impact expected on the CLFS rates, is in direct conflict
with the Administration's goal of reducing regulatory burden.
Response: As discussed in the proposed rule, including MA plan
payments as total Medicare revenues in the majority of Medicare
revenues threshold (as we currently do) dilutes the percentage of total
Medicare revenues attributed to CLFS and PFS revenues. As a result,
laboratories performing tests for a significant Medicare Part C
population are less likely to qualify as an applicable

[[Page 59670]]

laboratory and, therefore, to report applicable information to us.
For the additional data reporting burden, as discussed in the
Regulatory Impact Analysis in section VII. of the proposed rule (83 FR
36048), we estimated that excluding MA plan payments from total
Medicare revenues (the denominator) of the majority of Medicare
revenues threshold, and keeping the numerator constant (that is,
revenues from only the CLFS and or PFS) yielded an increase of 49
percent in the number of laboratories meeting the majority of Medicare
revenues threshold.
We also noted in the proposed rule that there would only be an
associated impact to the Medicare rates to the extent the additional
applicable laboratories are paid at a higher (or lower) private payor
rate, as compared to other laboratories that reported previously and to
the extent the volume of services performed by these additional
applicable laboratories is significant enough to make an impact on the
weighted median of private payor rates. Given that the largest
laboratories with the highest test volumes dominate the weighted median
of private payor rates, and the largest laboratories reported data for
the determination of CY 2018 CLFS rates and are expected to report
again, we stated that we do not expect the additional reported data
resulting from our proposed change to the majority of Medicare revenues
threshold to have a predictable, direct impact on CLFS rates. By this
we mean that we cannot predict whether the additional applicable
laboratories reporting applicable information are paid at a higher (or
lower) private payor rate, as compared to other laboratories that
reported previously and whether the private payor rate volume of
services performed by these additional applicable laboratories is
significant enough to make an impact on the weighted median of private
payor rates.
However, as we noted in the proposed rule, our proposal to exclude
MA plan payments from total Medicare revenues responded directly to
stakeholder concerns regarding the number of applicable laboratories
reporting applicable information for the initial data reporting period.
We believe that enabling more laboratories of all types that furnish
testing to a significant Medicare Part C population to qualify as
applicable laboratories and report data to CMS directly supports our
goal of collecting as much applicable information as possible from the
broadest representation of the national laboratory market on which to
base CLFS payment amounts. Therefore, we believe receiving additional
applicable information from more laboratories of all laboratory types
outweighs the additional reporting burden on laboratories.
Comment: One commenter disagreed with CMS' proposal to define MA
plan payments as private payor payments and not Medicare revenues for
the purpose of determining applicable laboratory status. The commenter
stated that MA plans are Medicare plans that rarely negotiate a rate
that varies from the Medicare payment rate and that using MA plan
payments to develop Medicare rates is simply a circular reference. The
commenter also stated that Medicaid managed care plans should not be
considered as a private payor because state Medicaid programs may set
laboratory test rates at a percentage of the Medicare CLFS, for
example, 80 percent of the Medicare CLFS rate. As such, the commenter
stated that the use of Medicaid managed care plan data will create a
``downward spiral'' of CLFS rates.
Response: Sections 1834A(a)(8)(B) and (C) of the Act define a
private payor to include a Medicare Advantage plan under Part C, and a
Medicaid managed care organization (as defined in section 1903(m) of
the Act), respectively. Therefore, the statute would not permit us to
exclude a Medicare Advantage plan under Part C or a Medicaid managed
care organization from the definition of private payor for the purposes
of determining the applicable information reported to us from which to
set CLFS rates. We understand the commenter's concern regarding the
potential circularity of using Medicaid managed care and MA plan data
to set Medicare CLFS rates to the extent that Medicaid managed care and
MA plan rates are established based on Medicare rates. However, we note
that section 1834A(a) of the Act explicitly directs us to use such data
in setting the CLFS rates. For the suggestion that including Medicaid
managed care plan data will result in a ``downward spiral,'' we note
that the statute anticipates that rates will decrease under the new
private payor rate-based CLFS and provides a phase-in of payment
reductions. Section 1834A(b)(3) of the Act, implemented at Sec.
414.507(d), limits the amounts the CLFS rates for each CDLT (that is
not a new ADLT or new CDLT) can be reduced as compared to the payment
rates for the preceding year. For the first 3 years after
implementation (CY 2018 through CY 2020), the reduction cannot be more
than 10 percent per year, and for the next 3 years (CY 2021 through CY
2023), the reduction cannot be more than 15 percent per year. We also
note that the Medicaid managed care plans may or may not be obligated
to continue to use Medicare rates (or a reduction thereof) as a basis
for their rates were such a ``downward spiral'' to occur.
Comment: One commenter urged CMS to conduct a more robust and
transparent analysis of this proposal to identify the types of
laboratories to which this policy would apply and the relative impact
on payment rates. The commenter also requested that CMS release the
number of clinical laboratories that previously reported applicable
information, based on market segment and geographic locations. The
commenter asserted that without such information, it would be premature
to implement a proposal that will only increase administrative burden
on hospitals and other organizations which will be forced to re-
determine their applicable laboratory status.
Response: As discussed previously, our proposal to exclude MA plan
payments from the total Medicare revenues for purposes of applying the
majority of Medicare revenues threshold would affect laboratories of
all types, that is hospital laboratories, large and small independent
laboratories, and physician office laboratories that furnish services
to a significant Medicare Part C enrollment population. We also
explained that since the largest laboratories with the highest test
volumes dominate the weighted median of private payor rates, and the
largest laboratories reported data for the determination of CY 2018
CLFS rates and are expected to report again, we did not expect the
additional reported data resulting from our proposed change to the
majority of Medicare revenues threshold to have a predictable, direct
impact on CLFS rates. As we noted previously, this means that we cannot
predict whether the additional applicable laboratories reporting
applicable information are paid at a higher (or lower) private payor
rate, as compared to other laboratories that reported previously and
whether the private payor rate volume of services performed by these
``additional'' applicable laboratories is significant enough to make an
impact on the weighted median of private payor rates. However, we noted
that we believe this proposal responded directly to stakeholder
concerns regarding the number of applicable laboratories reporting
applicable information for the initial data reporting period (83 FR
36049). We also noted that in the previous data reporting period we
received applicable information from 1,942 applicable laboratories from
every state, the District of Columbia, and

[[Page 59671]]

Puerto Rico, and that additional summary information regarding data
reporting for the Medicare CLFS from the first data reporting period is
available on the CLFS website at https://www.cms.gov/Medicare/Medicare-
Fee-for-Service-Payment/ClinicalLabFeeSched/Downloads/CY2018-CLFS-
Payment-System-Summary-Data.pdf.
Given that section 1834A(a)(8)(B) of the Act specifically defines
MA plans under Part C as private payors, and an applicable laboratory
that receives MA plan payments must consider those MA plan payments in
identifying its applicable information for reporting, we believe that
it is more logical to consider MA plan payments only as private payor
rates for purposes of reporting applicable information, rather than
both private payor rates and Medicare revenues. We believe this is
consistent with the statute and will help to increase laboratory
participation from all types of laboratories. At the same time, we
recognize the administrative concerns raised by some commenters
regarding the data reporting requirements for laboratories with a
significant Medicare Part C revenue component, particularly as some of
these laboratories may be small physician offices or independent
laboratories, which we have previously discussed as having a
significant burden in reporting applicable information. However, as
discussed previously in response to comments, we believe that modifying
our definition of applicable laboratory so that we may receive
applicable information from more laboratories that furnish tests to a
significant Medicare Part C population, which are less likely to
qualify for applicable laboratory status under the current policy,
outweighs the additional reporting burden placed on these laboratories
as well as directly supports our goal of collecting as much applicable
information as possible from the broadest representation of the
national laboratory market on which to base CLFS payment amounts. For
these reasons we are finalizing our proposal to modify the definition
of applicable laboratory to exclude MA plan revenues from total
Medicare revenues (the denominator of the majority of Medicare revenues
threshold). We are revising paragraph (3) of the definition of
applicable laboratory at Sec. 414.502 accordingly.
Comment: In addition to CMS' proposal to exclude MA plan payments
from total Medicare revenues, one commenter recommended that CMS also
remove prescription drug payments under Medicare Part D from the
description of total Medicare revenues in the applicable laboratory
definition. The commenter stated that including Part D payments is
illogical because there is no circumstance under which such payments
would be related to laboratory testing.
Response: As discussed previously, we are finalizing our proposal
to modify the definition of applicable laboratory to exclude MA plan
payments from total Medicare revenues, the denominator of the majority
of Medicare revenues threshold, so that more types of laboratories may
qualify as an applicable laboratory. While the agency did not propose
or solicit comments on the possibility of excluding Medicare Part D
revenues from total Medicare revenues, we will take the commenter's
suggestion into consideration for future refinements to the CLFS.
However, we note that if the commenter is correct that there is no
circumstance under which such payments would be related to laboratory
testing, then whether Part D payments are included or excluded from the
denominator would have no effect on the calculation.
4. Solicitation of Public Comments on Other Approaches To Defining
Applicable Laboratory
As discussed in the CY 2019 PFS proposed rule (83 FR 35858), and as
noted previously, we define applicable laboratory at the NPI level,
which means the laboratory's own billing NPI is used to identify a
laboratory's revenues for purposes of determining whether it meets the
majority of Medicare revenues threshold and the low expenditure
threshold components of the applicable laboratory definition. For
background purposes, the following summarizes some of the
considerations we made in establishing this policy.
In the CLFS proposed rule, entitled Medicare Clinical Diagnostic
Laboratory Tests Payment System, published in the October 1, 2015
Federal Register, we proposed to define applicable laboratory at the
TIN level so that an applicable laboratory would be an entity that
reports tax-related information to the IRS under a TIN with which all
of the NPIs in the entity are associated, and was itself a laboratory
or had at least one component that was a laboratory, as defined in
Sec. 493.2. In the CLFS proposed rule, we discussed that we considered
proposing to define applicable laboratory at the NPI level. However, we
did not propose that approach because we believed private payor rates
for CDLTs are negotiated at the TIN level and not by individual
laboratory locations at the NPI level. Numerous stakeholders had
indicated that the TIN-level entity is the entity negotiating pricing,
and therefore, is the entity in the best position to compile and report
applicable information across its multiple NPIs when there are multiple
NPIs associated with a TIN-level entity. We stated that we believed
defining applicable laboratory by TIN rather than NPI would result in
the same applicable information being reported, and would require
reporting by fewer entities, and therefore, would be less burdensome to
applicable laboratories. In addition, we stated that we did not believe
reporting at the TIN level would affect or diminish the quality of the
applicable information reported. To the extent the information is
accurately reported, we expected reporting at a higher organizational
level to produce exactly the same applicable information as reporting
at a lower level (80 FR 59391 through 59393).
Commenters who objected to our proposal to define applicable
laboratory at the TIN level stated that our definition would exclude
hospital laboratories because, in calculating the applicable
laboratory's majority of Medicare revenues amount, which looks at the
percentage of Medicare revenues from the PFS and CLFS across the entire
TIN-level entity, virtually all hospital laboratories would not be
considered an applicable laboratory. Many commenters expressed
particular concern that our proposed definition would exclude hospital
outreach laboratories, stating that hospital outreach laboratories,
which do not provide laboratory services to hospital patients, are
direct competitors of the broader independent laboratory market, and
therefore, excluding them from the definition of applicable laboratory
would result in incomplete and inappropriate applicable information,
which would skew CLFS payment rates. Commenters maintained that CMS
needed to ensure reporting by a broad scope of the laboratory market to
meet what they viewed as the intent of the statute that all sectors of
the laboratory market be included to establish accurate market-based
rates (81 FR 41045).
In issuing the CLFS final rule, we found particularly compelling
the comments that urged us to adopt a policy that would better enable
hospital outreach laboratories to be applicable laboratories because we
agreed hospital outreach laboratories should be included in determining
the new CLFS payment rates. We believed it was important to facilitate
reporting of private payor rates for hospital outreach laboratories to
ensure a broader representation of the national laboratory

[[Page 59672]]

market to use in setting CLFS payment amounts (81 FR 41045).
We also stated in the CLFS final rule that we believed the intent
of the statute was to effectively exclude hospital laboratories as
applicable laboratories, based on the statutory language, in
particular, regarding the majority of Medicare revenues threshold
criterion in section 1834A(a)(2) of the Act. Section 1834A(a)(2) of the
Act provides that, to qualify as an applicable laboratory, an entity's
revenues from the CLFS and the PFS need to constitute a majority of its
total Medicare payments received from the Medicare program for a data
collection period. What we found significant was that most hospital
laboratories would not meet that majority of Medicare revenues
threshold because their revenues under the Inpatient Prospective
Payment System (IPPS) and Outpatient Prospective Payment System (OPPS)
alone would likely far exceed the revenues they received under the CLFS
and PFS. Therefore, we stated that we believe the statute intended to
limit reporting primarily to independent laboratories and physician
offices (81 FR 41045 through 41047). For a full discussion of the
definition of applicable laboratory, see the CLFS final rule (81 FR
41041 through 41051).
a. Stakeholder Continuing Comments and Stakeholder-Suggested
Alternative Approaches
As noted above, in response to public comments, we had previously
finalized that an applicable laboratory is the NPI-level entity so that
a hospital outreach laboratory assigned a unique NPI, separate from the
hospital of which it is a part, is able to meet the definition of
applicable laboratory and its applicable information can be used for
CLFS rate-setting. We stated in the CY 2019 PFS proposed rule that we
continue to believe that the NPI is the most effective mechanism for
identifying Medicare revenues for purposes of determining applicable
laboratory status and identifying private payor rates for purposes of
reporting applicable information. Once a hospital outreach laboratory
obtains its own unique billing NPI and bills for services using its own
unique NPI, Medicare and private payor revenues are directly
attributable to the hospital outreach laboratory. By defining
applicable laboratory using the NPI, Medicare payments (for purposes of
determining applicable laboratory status) and private payor rates and
the associated volume of CDLTs can be more easily identified and
reported to us. We also noted that we believe that finalizing our
proposal to exclude MA plan payments under Medicare Part C from total
Medicare revenues in the definition of applicable laboratory may
increase the number of entities meeting the majority of Medicare
revenues threshold, and therefore, allow them to qualify for applicable
laboratory status. We stated that we believe that finalizing the change
to the total Medicare revenues component of the applicable laboratory
definition and our current policy that requires an entity to bill
Medicare Part B under its own NPI, may increase the number of hospital
outreach laboratories qualifying as applicable laboratories.
In addition, we noted that we are confident that our current policy
supports our collecting sufficient applicable information in the next
data reporting period, and that we received sufficient and reliable
applicable information with which we set CY 2018 CLFS rates, and that
those rates are accurate. We noted that we received applicable
information from laboratories in every state, the District of Columbia,
and Puerto Rico. This data included private payor rates for almost 248
million laboratory tests conducted by 1,942 applicable laboratories,
with over 4 million records of applicable information. As we have
noted, the largest laboratories dominate the market, and therefore,
most significantly affect the payment weights (81 FR 41049). We stated
that given that the largest laboratories reported their applicable
information to CMS in the initial data reporting period, along with
many smaller laboratories, we believe the data we used to calculate the
CY 2018 CLFS rates was sufficient and resulted in accurate weighted
medians of private payor rates.
However, we noted that we continue to consider refinements to our
policies that could lead to including even more applicable information
for the next data reporting period. Therefore, the comments and
alternative approaches suggested by commenters, even though some were
first raised prior to the CLFS final rule, were presented and offered
for comment as part of the proposed rule.
(1) Using Form CMS-1450 UB 04 (and Electronic Equivalent, 837I) 14X
Type of Bill (TOB) To Determine Majority of Medicare Revenues and Low
Expenditure Thresholds
Although an NPI-based definition of applicable laboratories
includes more hospital outreach laboratories than a TIN-based
definition, some commenters expressed concern that the NPI-based
definition of applicable laboratory may not be sufficient to capture
all of the hospital outreach laboratories. These commenters suggested
we revise the definition specifically for the purpose of including more
hospital outreach laboratories. Under a suggested approach, a
laboratory could determine whether it meets the majority of Medicare
revenues threshold and low expenditure threshold using only the
revenues from services reported on the Form CMS-1450 (approved Office
of Management and Budget number 0938-0997) 14x Type of Bill (TOB),
which is used only by hospital outreach laboratories. The CMS-1450 14X
TOB is the uniform bill (also known as the UB-04) for institutional
providers that was approved by the National Uniform Billing Committee
(NUBC) \8\ at its February 2005 meeting.
---------------------------------------------------------------------------

\8\ Copyright (copyright) 2012 the American Hospital
Association, Chicago, Illinois. Reproduced with permission. No
portion of this publication may be copied without the express
written consent of the AHA.
---------------------------------------------------------------------------

The data elements referenced in the UB-04 manual are also used in
the electronic claim standard as required by the Health Insurance
Portability and Accountability Act of 1996 (HIPAA) (Pub. L. 104-191,
enacted August 21, 1996) as per of sections 1171 and 1172 of the Act.
Consequently, there was additional emphasis placed on aligning the
reporting instructions to closely mirror the HIPAA claim standard for
institutional providers for both paper and electronic claims. The TOB
is a required element on both the UB 04 and electronic equivalent of
the 837I transaction of the HIPAA compliant 005010 standard
transaction. The NUBC defines the 14X TOB as an outpatient hospital
TOB, and it is used by hospitals to bill a payor for outreach
laboratory services for non-patients. As discussed in Transmittal 3425,
a non-patient is defined as a beneficiary who is neither an inpatient
nor an outpatient of a hospital, but who has a specimen that is
submitted for analysis to a hospital and the beneficiary is not
physically present at the hospital for purposes of the laboratory
service. All hospitals (including Critical Access Hospitals) bill non-
patient laboratory tests on a TOB 14X. They are paid under the CLFS,
and the Part B deductible and coinsurance do not apply. We believe that
laboratory services billed on the CMS 1450 14X encompass all of the
laboratory testing services.
To address this stakeholder's concern of including hospital
outreach laboratories, we solicited public comments in the CY 2019 PFS
on revising the definition of applicable laboratory to permit the
revenues identified on the Form CMS-1450 14x

[[Page 59673]]

TOB to be used instead of the revenues associated with the NPI that the
laboratory uses in order to determine whether it meets the majority of
Medicare revenues threshold (and the low expenditure threshold). Under
this approach, the applicable revenues would be based on the bills used
for hospital laboratory services provided to non-patients, which are
paid under Medicare Part B (that is, the 14x TOB). If we pursued this
approach, we explained that we would have to modify the definition of
applicable laboratory in Sec. 414.502 by indicating that an applicable
laboratory may include an entity that bills Medicare Part B on the Form
CMS-1450 14x TOB.
Although using the 14x TOB could alleviate some initial, albeit
limited, administrative burden on hospital outreach laboratories to
obtain a unique billing NPI, we explained that we would have
operational and statutory authority concerns about defining applicable
laboratory by the Form CMS-1450 14x TOB, as indicated below.
First, we explained that defining an applicable laboratory using
the Form CMS-1450 14x TOB does not identify an entity the same way an
NPI does. Whereas an NPI is associated with a provider or supplier to
determine specific Medicare revenues, the 14x TOB is merely a billing
mechanism that is currently used only for a limited set of services.
Under an approach that permits laboratories to meet the majority of
Medicare revenues threshold using the 14x TOB, private payor rates (and
the volume of tests paid at those rates) would have to be identified
that are associated with only the outreach laboratory services of a
hospital's laboratory business. However, some private payors, such as
MA plans, may not require hospital outreach laboratories to use the 14x
TOB for their outreach laboratory services. To the extent a private
payor does not require hospital outreach laboratory services to be
billed on a 14x TOB (which specifically identifies outreach services),
hospitals may need to develop their own mechanism for identifying and
reporting only the applicable information associated with its hospital
outreach laboratory services. In light of this possible scenario, we
requested public comments about the utility of using the 14x TOB in the
way we have described and on the level of administrative burden created
if we defined applicable laboratory using the Form CMS-1450 14x TOB.
Second, we questioned whether hospitals would have sufficient time
after publication of a new final rule that included using the Form CMS-
1450 14x TOB, and any related subregulatory guidance, to develop and
implement the information systems necessary to collect private payor
rate data before the start of the next data collection period, that is,
January 1, 2019. Therefore, we solicited public comments as to whether
revising the definition of applicable laboratory to use the Form CMS-
1450 14x TOB would allow laboratories sufficient time to make the
necessary systems changes to identify applicable information before the
start of the next data collection period.
Third, we noted that we believe defining applicable laboratory at
the NPI level, as we currently do, provides flexibility for hospital
outreach laboratories to not obtain a unique billing NPI, which may be
burdensome, particularly where a hospital outreach laboratory performs
relatively few outreach services under Medicare Part B. For example,
under the current definition of applicable laboratory, if a hospital
outreach laboratory's CLFS revenues in a data collection period are
typically less than the low expenditure threshold, the hospital of
which it is a part could choose not to obtain a separate NPI for its
outreach laboratory and could thus avoid determining applicable
laboratory status for its outreach laboratory component. In contrast,
if laboratories were permitted to use the Form CMS-1450 14x TOB,
revenues attributed to the hospital outreach laboratory would have to
be calculated in every instance where those services exceeded the low
expenditure threshold. This would be true even for a hospital outreach
laboratory that performs relatively few outreach services under
Medicare Part B. Therefore, we also solicited comments concerning this
aspect of using the 14x TOB definition.
Fourth, and significantly, we stated that we believe that if we
were to utilize such an approach in defining applicable laboratory, all
hospital outreach laboratories would meet the majority of Medicare
revenues threshold. We noted, at that time, we believed this approach
would be inconsistent with the statute. By virtue of the majority of
Medicare revenues threshold, the statute defines applicable laboratory
in such a way that not all laboratories qualify as applicable
laboratories. However, if we were to use the CMS-1450 14x TOB to define
an applicable laboratory, all hospital outreach laboratories that use
the 14x TOB would meet the majority of Medicare revenues threshold.
Accordingly, we requested public comments regarding whether this
definition would indeed be inconsistent with the statute, as well as
comments that could identify circumstances under this definition
whereby a hospital outreach laboratory would not meet the majority of
Medicare revenues threshold.
The following is a summary of the comments we received and our
responses to the comments regarding the use of the CMS-1450 14x TOB to
define an applicable laboratory.
Comment: We received conflicting comments on this potential
refinement to the definition of an applicable laboratory. Some
commenters supported using the CMS-1450 14x TOB as a mechanism to
define an applicable laboratory, and others were opposed to this
approach. The commenters who supported this believe that it provides an
opportunity for hospital outreach laboratories that have not obtained
an NPI separate from the hospital to qualify as an applicable
laboratory and report applicable information. These commenters opined
that since the 14X TOB is used only to submit claims by hospital
outreach laboratories for non-patient claims, this approach would
include hospital laboratories without their own NPI who compete in the
marketplace with independent clinical laboratories. These commenters
also noted that, in their view, this approach would effectuate
Congress' intent to determine whether a majority of Medicare revenues
attributable to the laboratory part of the hospital--as opposed to the
entire hospital--was from the CLFS and/or PFS.
Another commenter stated their view that considerable burden is
associated with requiring a hospital outreach laboratory to obtain its
own NPI. According to this commenter, a hospital would need to re-
credential under a new NPI with each of their payors in order to submit
claims and receive payment from each of their payors for their hospital
outreach laboratory services. This commenter stated that this process
could take more than a year to complete. Accordingly, this commenter
concluded that hospital outreach laboratories rarely obtain their own
unique NPI (separate from the hospital) and it would not be practical
to do so for the single purpose of reporting applicable information to
CMS.
Additional commenters in support of refinements to the definition
responded to CMS' concern that revenues attributed to the hospital
outreach laboratory would have to be calculated in every instance where
those services exceeded the low expenditure threshold, even for a
hospital outreach laboratory that performs relatively few outreach
services under Medicare Part

[[Page 59674]]

B. In response to this concern, commenters noted that this refinement
to the definition would require hospital outreach laboratories to have
the same obligations as other laboratories that exceed the low
expenditure threshold and that serve non-hospital patients.
Furthermore, commenters suggested that if CMS is concerned that
refinements to the definition would result in all hospital outreach
laboratories meeting the majority of Medicare revenues threshold, that
is the case for almost all independent laboratories, as well, where
hospital outreach laboratories compete with independent laboratories in
the marketplace. Furthermore, they stated it is reasonable that a
laboratory whose revenues are derived primarily from the CLFS and/or
PFS and that meets the low expenditure threshold be included in data
reporting, regardless if it is a hospital outreach laboratory.
In contrast, several commenters strongly opposed the use of Form
CMS-1450 14x TOB to define an applicable laboratory because of their
views of the additional administrative burden for hospitals relative to
the effect on CLFS rates. These commenters stated that even if every
hospital outreach laboratory were to report private payor data, it is
unlikely that it would result in a significant change to the weighted
median of private payor rates due to the massive amount of data that
would be reported by the large independent laboratories. They also
agreed with the potential operational feasibility concerns we raised in
the proposed rule.
Response: We appreciate the comments raised about the
administrative aspects of obtaining an NPI for a hospital outreach
laboratory for the sole purpose of reporting data to CMS and the
associated administrative burden. We agree that one advantage of using
the Form CMS-1450 14x TOB to define an applicable laboratory is that it
provides an opportunity for more hospital outreach laboratories to
report data for calculating CLFS rates. However, we also recognize that
this will result in additional administrative burden on the hospital
industry, such as changes to collect and report applicable information.
We discuss specific operational concerns in more detail in the sections
below. However, we generally believe that this advantage outweighs the
potential burden for hospital outreach laboratories, the data collected
from hospital outreach laboratories will create a dataset that is a
more robust representation of the laboratory testing market, and that
this outweighs the potential burden to hospital outreach laboratories.
Accordingly, we are finalizing the use of the Form CMS-1450 14x TOB to
define applicable laboratories for the next data collection period
(January 1, 2019, through June 30, 2019) and the next data reporting
period (January 1, 2020, and ends March 31, 2020), subject to other
regulatory and subregulatory requirements, such as the regulatory low
expenditure threshold.
We also considered the comments regarding the limited impact of
this additional data to the weighted median of private payor rates. We
believe that we will only know the impact of the data on CLFS rates by
collecting data from hospital outreach laboratories. We believe
inclusion of this information so that the CLFS rates better reflect the
market outweighs the potential added burden on one segment of the
market. However, if it becomes apparent that data from hospital
outreach laboratories do not result in a significant change in the
weighted median of private payor rates, we will revisit the use of the
CMS-1450 14x TOB through future rulemaking.
Comment: A few commenters stated that CMS should not be concerned
that hospitals will need to develop additional mechanisms to identify
applicable information if private payors do not require hospital
outreach laboratories to use the CMS-1450 14x TOB. They noted that this
point is not relevant to reporting private payor rates because once
applicable laboratory status is determined, the hospital outreach
laboratory ``can simply report its private payor data for all of its
fee for service work that is not part of a capitated plan.'' The
commenters stated that the reporting entities for all other laboratory
types would have the same burden as hospital outreach laboratories,
that is, of identifying and reporting accurate applicable information.
In contrast, several stakeholders raised concerns about the
implications this alternative approach would have on identifying
applicable information for purposes of reporting that data to us. They
stated that the Form CMS-1450 14x TOB will only capture Medicare Part B
revenues, while private payor data would not be captured. In other
words, the 14x TOB will correctly identify Medicare Part B revenues for
purposes of determining applicable laboratory status, but that the
hospital would be responsible for correctly identifying and collecting
applicable information associated solely with the hospital outreach
laboratory. Several commenters stated that billing systems for hospital
outreach laboratories are not set up in a manner that allows this type
of information to be easily extracted, and therefore, this approach to
defining an applicable laboratory would pose a significant operational
burden on hospitals.
Response: We note that hospital outreach laboratories who meet the
definition of an applicable laboratory would have the same burden of
identifying and reporting accurate applicable information as all other
laboratory types that meet the definition of an applicable laboratory.
Comment: Some commenters stated that they believe hospitals would
have sufficient time to develop and implement the information systems
necessary to collect private payor rate data before the start of the
next data collection period, and noted that even though the CLFS final
rule was published less than 2 weeks prior to the end of the first data
collection period, applicable laboratories were able to develop and
implement the information systems necessary to collect private payor
rate data and report it to CMS. However, several commenters expressed
serious concerns about developing the systems to collect applicable
information before the next data reporting period. They indicated that
finalizing this alternative approach for defining an applicable
laboratory would not allow hospital outreach laboratories sufficient
time to make the necessary systems changes prior to the start of the
next data collection, and as a result, there would be a risk that
inaccurate data would be reported.
Response: As discussed previously in this section, the next data
collection period is January 1, 2019, through June 30, 2019. A 6-month
window follows the data collection period from July 1, 2019, through
December 31, 2019 and the next data reporting period begins January 1,
2020, and ends March 31, 2020. While several commenters raised concerns
about the operational changes needed for reporting before the next data
collection period, we believe that, similar to the retroactive data
collection that occurred under the initial private payor rate-based
CLFS, hospitals, including the part of the hospital represented by
their hospital outreach laboratories, could develop these operational
changes in time. For example, hospitals, including the part of the
hospital represented by their hospital outreach laboratories, could use
the time before and during the next data collection period to develop
processes to collect applicable information, the 6-month window between
the collection and reporting periods to determine applicable laboratory
status and retroactively collect applicable

[[Page 59675]]

information to report it before the close of the next data reporting
period (March 31, 2020).
Comment: Many commenters noted the concern that hospital outreach
laboratories would lose the flexibility to not obtain an NPI for low
volume hospital outreach laboratories. For instance, they stated all
hospitals would be required to go through the exercise of determining
applicable laboratory status for their hospital outreach laboratory
components. However, a few commenters indicated that hospital outreach
laboratories would have the same obligations as every other laboratory
to determine whether it is an applicable laboratory. Therefore, in
their view, the loss of flexibility for hospital outreach laboratories
to not obtain an NPI should not be a concern.
Response: We agree that the use of Form CMS-1450 14x TOB to define
an applicable laboratory will require hospitals to assess applicable
laboratory status for all outreach laboratory components, similar to
the obligations of other laboratory types. For instance, all
independent and physician office laboratories billing Medicare Part B
under their own NPI must assess whether they qualify as an applicable
laboratory, and if so, report applicable information to us.
Consequently, independent and physician office laboratories do not have
the flexibility of not reporting private payor data that is currently
afforded to hospital outpatient laboratories. Use of the 14x TOB to
define an applicable laboratory would equalize the obligations across
laboratories, regardless of their affiliation with a hospital, to
determine whether they qualify for applicable laboratory status. We
note that, insofar as commenters expressed concern about low volume
hospital outreach laboratories, our policy regarding laboratories
receiving less than a minimum in CLFS revenues remains unchanged.
Specifically, hospital outreach laboratories that do not receive at
least $12,500 in CLFS revenues on the 14X TOB during a data collection
period would be exempt from the reporting requirements.
Comment: Several commenters noted that by using the 14x TOB to
define an applicable laboratory, all hospital outreach laboratories
would meet the majority of Medicare revenues threshold. They,
therefore, raised concerns about the legality of this approach. For
instance, some commenters stated their view that Congress did not
intend for all hospital outreach laboratories to qualify as applicable
laboratories. In contrast, some commenters stated their view that
Congress clearly intended for the CLFS to reflect a market-based system
that includes hospital outreach laboratories and that it is reasonable
for a laboratory with revenues derived primarily from the CLFS and/or
PFS that also meets the low expenditure threshold to be an applicable
laboratory, regardless of whether it is a hospital outreach laboratory
or not.
Response: After further review of this issue, we believe that using
Form CMS-1450 14x TOB provides a means of distinguishing services
furnished by a hospital outreach laboratory from other services
furnished and billed by a hospital using the same NPI. The statute
specifically directs us to identify applicable ``laboratories'' and not
``providers'' or ``suppliers.'' We believe that hospital outreach
laboratories without unique NPIs furnish clinical laboratory tests paid
under the CLFS and PFS, albeit to Medicare beneficiaries who are not
hospital patients. Accordingly, we believe such laboratories, should
not be exempt from reporting the applicable data merely due to their
shared use of a billing entity with a hospital.
Using the laboratory's own billing NPI as the basis for defining
applicable laboratory, as we currently do, results in all independent
laboratories meeting the statutory ``majority of Medicare revenues''
requirement because most, if not all, of an independent laboratory's
Medicare revenues are received from the PFS and or CLFS. Similar to how
the use of the NPI results in all independent laboratories meeting the
majority of Medicare revenues threshold, using the Form CMS-1450 14x
TOB as the basis for defining applicable laboratory would identify all
hospital outreach laboratories that meet the statutorily required
``majority of Medicare revenues'' component of applicable laboratory.
We believe that the use of Form CMS-1450 14x TOB as a mechanism for
applying the majority of Medicare revenues threshold identifies
hospital outreach laboratories that meet this threshold, consistent
with the statutory requirement for applicable laboratory status. We
further believe that, absent having an NPI separate from the hospital,
these hospital outreach laboratories otherwise would be excluded. We do
not believe that the statute excludes laboratories that meet the
majority of Medicare revenues threshold from potentially qualifying as
an applicable laboratory. Therefore, using the 14x TOB to define
applicable laboratory is consistent with the statute.
As stated above, accordingly, we are finalizing the use of the Form
CMS-1450 14x TOB to define applicable laboratories, subject to other
regulatory and subregulatory requirements, such as the regulatory low
expenditure threshold.
Comment: Two commenters stated that it is unclear whether the
burden associated with considering every hospital outreach laboratory
to meet the majority of Medicare revenues threshold and an applicable
laboratory (if the low expenditure threshold is also met) would
outweigh the additional applicable information that would be reported.
Therefore, they requested that we continue evaluating this approach
before implementing any changes.
Response: As we stated previously, we generally believe that the
advantage of including private payor data from hospital outreach
laboratories in setting CLFS rates outweighs the potential burden for
hospital outreach laboratories; data collected from hospital outreach
laboratories will create a dataset that is a more robust representation
of the laboratory testing market. We also note that the timing of the
data collection and reporting periods, and the 6 month window in
between provide time for laboratories to implement needed operational
changes.
Comment: One commenter suggested that an alternative approach to
identifying applicable laboratories would be for the hospital to
develop an ``adjustment factor'' based on its payment-to-charges ratio
to estimate laboratory revenues received from the IPPS and OPPS. The
same commenter suggested that we remove the requirement that an
applicable laboratory is an entity that bills Medicare Part B under its
own NPI and that we amend the majority of Medicare revenues threshold
so that ``Medicare revenues'' means payment for claims submitted on a
CMS 1500, a CMS 1450 using a 14x TOB, or their electronic equivalents.
Response: We appreciate this suggested approach and we may consider
it in future rulemaking.
In conclusion, as stated previously and for the reasons described
previously, we are finalizing the use of the Form CMS-1450 14x TOB to
define applicable laboratories, subject to other regulatory and
subregulatory requirements, such as the regulatory low expenditure
threshold.
We note that because of the low expenditure threshold, not all
hospital outreach laboratories would meet the definition of an
applicable laboratory and therefore not all hospital outreach
laboratories would be required to report applicable information to us.
In other words, hospital outreach laboratories

[[Page 59676]]

that do not receive at least $12,500 in CLFS revenues on the 14X TOB
during a data collection period would be exempt from the reporting
requirements.
We believe that defining applicable laboratory by the NPI may be
preferable to using the CMS-1450 14x TOB for some hospitals and so
expect that some hospital outreach laboratories may still want to
obtain their own billing NPI separate from the hospital. As such, they
may do so and may qualify as an applicable laboratory in this manner.
If so, they would report applicable information during the next data
reporting period beginning January 1, 2020, through March 31, 2020.
We note that we utilize ongoing subregulatory guidance and provider
education materials to provide more details regarding how applicable
laboratories, both those identified through NPIs and hospital outreach
laboratories identified through the combination of NPI and services
reported using the 14x TOBs, are to report the applicable data to CMS.
We also note that for hospitals which have an applicable laboratory,
whether via its own NPI for its outreach laboratory or by identifying
its status with the 14X TOB, the applicable laboratory would be
required to report applicable information by March 31, 2020, for
services reimbursed for the period between January 1, 2019, and June
30, 2019.
In conclusion, as stated previously, we are finalizing the use of
the Form CMS-1450 14x TOB to define applicable laboratories. In other
words, we are finalizing modification of the definition of applicable
laboratory to also include 14X TOB revenues. We will also revise
paragraph (2) of the definition of applicable laboratory at Sec.
414.502 accordingly.
(2) Using CLIA Certificate To Define Applicable Laboratories
Some commenters requested that we use the CLIA certificate rather
than the NPI to identify a laboratory that would be considered an
applicable laboratory. We discussed in the CLFS proposed rule (80 FR
59392) why not all entities that meet the CLIA regulatory definition at
Sec. 493.2 would be applicable laboratories, and therefore, we did not
propose to use the CLIA certificate as the mechanism for defining
applicable laboratory. However, some commenters to the CLFS proposed
rule suggested we use the CLIA certificate to identify the
organizational entity that would be considered an applicable laboratory
so that each entity that had a CLIA certificate would be an applicable
laboratory (81 FR 41045). We considered those comments in the CLFS
final rule and discussed why we chose not to adopt that approach.
Among other reasons, we explained in the CLFS final rule that we
believed a CLIA certificate-based definition of applicable laboratory
would be overly inclusive by including all hospital laboratories, as
opposed to just hospital outreach laboratories. In addition, the CLIA
certificate is used to certify that a laboratory meets applicable
health and safety regulations in order to furnish laboratory services.
Unlike, for example, the NPI, with which revenues for specific services
can easily be identified, the CLIA certificate is not associated with
Medicare billing and cannot be used to identify revenues for specific
services. We also indicated that we did not know how a hospital would
determine whether its laboratories would meet the majority of Medicare
revenues threshold (and the low expenditure threshold) using the CLIA
certificate as the basis for defining an applicable laboratory. In
addition, we stated that, given the difficulties many hospitals would
likely have in determining whether their laboratories are applicable
laboratories, we also believed hospitals may object to using the CLIA
certificate (81 FR 41045).
However, in light of stakeholders' suggestions to use the CLIA
certificate to include hospital outreach laboratories in the definition
of applicable laboratories, we solicited public comments on that
approach. Under such an approach, the majority of Medicare revenues
threshold and low expenditure threshold components of the definition of
applicable laboratory would be determined at the CLIA certificate level
instead of the NPI level. We explained that if we pursued such an
approach, we would have to modify the definition of applicable
laboratory in Sec. 414.502 to indicate that an applicable laboratory
is one that holds a CLIA certificate under Sec. 493.2 of the chapter.
We noted in the CY 2019 PFS proposed rule that we would have concerns,
however, about defining applicable laboratory by the CLIA certificate.
First, we explained that as we discussed in the CLFS final rule,
given that information regarding the CLIA certificate is not required
on the Form CMS-1450 14x TOB, which is the billing form used by
hospitals for their laboratory outreach services, it is not clear how a
hospital would identify and distinguish revenues generated by its
separately CLIA-certified laboratories for their outreach services.
Therefore, we solicited public comments regarding the mechanisms a
hospital would need to develop to identify revenues if we used the CLIA
certificate for purposes of determining applicable laboratory status,
as well as comments about the administrative burden associated with
developing such mechanisms.
In addition, we understood there could be a scenario where one CLIA
certificate is assigned to a hospital's entire laboratory business,
which would include laboratory tests performed for hospital patients as
well as non-patients (that is, patients who are not admitted inpatients
or registered outpatients of the hospital). For example, hospital
laboratories with an outreach laboratory component would be assigned a
single CLIA certificate if the hospital outreach laboratory has the
same mailing address or location as the hospital laboratory. We noted
that in this scenario, the majority of Medicare revenues threshold
would be applied to the entire hospital laboratory, not just its
outreach laboratory component. If a single CLIA certificate is assigned
to the hospital's entire laboratory business, the hospital laboratory
would be unlikely to meet the majority of Medicare revenues threshold
because its laboratory revenues under the IPPS and OPPS alone would
likely far exceed the revenues it receives under the CLFS and PFS. As a
result, a hospital outreach laboratory that could otherwise meet the
definition of applicable laboratory, as currently defined at the NPI
level, would not be an applicable laboratory if we were to require the
CLIA certificate to define applicable laboratory. Given that this
approach could have the effect of decreasing as opposed to increasing
the number of applicable laboratories, we requested public comments on
this potential drawback of defining applicable laboratory at the CLIA
certificate level. We stated in the comment solicitation that feedback
on this topic could help inform us regarding potential refinements to
the definition of applicable laboratory, and that depending on the
comments we receive, it is possible we would consider approaches
described in that section. The following is a summary of the comments
we received and our responses to the comments regarding the use of the
CLIA certificate to define an applicable laboratory.
Comment: Many commenters did not support using the CLIA certificate
to define applicable laboratory because of the administrative
complexity associated with this approach. Commenters stated that the
CLIA certificate has no relationship to actual laboratory revenues,
like the NPI does, and therefore, laboratories would need to develop
their own mechanisms to attribute Medicare revenues to the CLIA

[[Page 59677]]

certificate. Commenters stated that any ``workaround'' to resolve these
issues would be extremely burdensome to develop and implement. These
same commenters also noted that when one CLIA certificate is assigned
to a hospital's entire laboratory business, which would include
laboratory tests performed for hospital patients as well as non-
patients, the total Medicare revenues component of the majority of
Medicare revenues threshold equation would be ``overly inclusive.''
Therefore, they agreed with CMS' concern that hospital outreach
laboratories would be unlikely to meet the majority of Medicare
revenues threshold under those circumstances because revenues from the
IPPS and OPPS alone would likely far exceed the revenues those
laboratories receive under the CLFS and PFS. For these reasons, they
encouraged CMS to reject the use of the CLIA certificate for defining
an applicable laboratory.
Response: We agree that defining applicable laboratory by the CLIA
certificate would result in substantial administrative burden for the
laboratory industry. From an administrative perspective, we believe the
using the CLIA certificate unworkable for the purpose of determining
applicable laboratory status because the CLIA certificate is not
required on the CMS 1450 14x TOB which is the billing form used by
hospital outreach laboratories. Therefore, no revenues can be readily
identified by the CLIA certificate. Even if the hospital developed its
own mechanism to identify revenues by the CLIA certificate, the CLIA
certificate could be assigned to the hospital's entire laboratory
business, which includes laboratory tests performed for hospital
patients, as well as non-patients. For example, we understand hospital-
based laboratories with an outreach component would be assigned a
single CLIA certificate if the hospital outreach laboratory has the
same mailing address or location as the main laboratory. In this
scenario, the applicable laboratory criteria would be applied to the
CLIA certificate of the entire hospital laboratory not just its
outreach laboratory component. When a single CLIA certificate is
assigned to the hospital's entire laboratory business, we believe it
would result in the hospital laboratory not meeting the majority of
Medicare revenues threshold because its laboratory revenues under the
IPPS and OPPS alone will far exceed the revenues it receives under the
CLFS and PFS. We also understand that a hospital could have multiple
outreach laboratories each with its own CLIA certificate. Therefore, we
believe those hospitals would also have difficulties separating
Medicare revenues and applicable information among their various CLIA
certificates as described below.
Comment: One commenter stated that it is unlikely that a single
CLIA certificate would be assigned to both its outreach laboratory
(non-patients) and its laboratory that that provides testing for its
hospital inpatients and hospital outpatients. The commenter stated that
it would be more likely that the outreach laboratory would be at a
different location than the hospital and therefore, be assigned its own
CLIA certificate even though the outreach laboratory is enrolled in the
Medicare program under the hospital's NPI. As such, the commenter
stated that an outreach laboratory operates as a distinct laboratory
entity by virtue of having its own CLIA certificate and billing on the
Form CMS-1450 14x TOB. The commenter suggested that the 14x TOB could
be used in combination with each individual CLIA certificate to define
applicable laboratory.
Response: We understand that the assignment of CLIA certificates
for hospital outreach laboratories could vary depending on the location
of the outreach laboratory. As discussed previously, Medicare revenues
are not attributed to the CLIA certificate and information regarding
the CLIA certificate is not required on the Form CMS-1450 14x TOB. As
such, we believe the commenter's suggestion would result in defining
applicable laboratory by the Form CMS-1450 14x TOB. We note that in
cases in which a hospital owns and operates multiple outreach
laboratories at different locations, we believe the administrative
burden of attributing Medicare revenues to the CLIA certificate would
be even more substantial as there could be several CLIA certificates
assigned under the same NPI. In such cases, the hospital would need to
attribute laboratory revenues among multiple CLIA certificates under
the same billing entity. In other words, if the 14x TOB is used by a
hospital to bill for laboratory tests furnished by more than one CLIA
certificate under the same NPI, the hospital would need to devise a
mechanism to attribute Medicare revenues to each individual CLIA
certificate.
5. Solicitation of Public Comments on the Low Expenditure Threshold in
the Definition of Applicable Laboratory
a. Decreasing the Low Expenditure Threshold
In the CLFS final rule, we established a low expenditure threshold
component in the definition of applicable laboratory at Sec. 414.502,
which is reflected in paragraph (4). To be an applicable laboratory, at
least $12,500 of an entity's Medicare revenues in a data collection
period must be CLFS revenues (with the exception that there is no low
expenditure threshold for an entity with respect to the ADLTs it
furnishes). We established $12,500 as the low expenditure threshold
because we believed it achieved a balance between collecting sufficient
data to calculate a weighted median that appropriately reflects the
private market rate for a test, and minimizing the reporting burden for
laboratories that receive a relatively small amount of revenues under
the CLFS. We indicated in the CLFS final rule (81 FR 41049) that once
we obtained applicable information under the new payment system, we may
decide to reevaluate the low expenditure threshold in future years and
propose a different threshold amount through notice and comment
rulemaking.
We explained in the CY 2019 PFS proposed rule that we recently
heard from some laboratory stakeholders that the low expenditure
threshold excludes most physician office laboratories and many small
independent laboratories from reporting applicable information, and
that by excluding so many laboratories, the payment rates under the new
private payor rate-based CLFS reflect incomplete data, and therefore,
inaccurate CLFS pricing.
As noted previously, we discussed in the CLFS final rule that we
believed a $12,500 low expenditure threshold would reduce the reporting
burden on small laboratories. In the CLFS final rule (81 FR 41051), we
estimated that 95 percent of physician office laboratories and 55
percent of independent laboratories would not be required to report
applicable information under our low expenditure criterion. Although we
substantially reduced the number of laboratories qualifying as
applicable laboratories (that is, approximately 5 percent of physician
office laboratories and approximately 45 percent of independent
laboratories), we estimated that the percentage of Medicare utilization
would remain high. That is, approximately 5 percent of physician office
laboratories would account for approximately 92 percent of CLFS

[[Page 59678]]

spending on physician office laboratories and approximately 45 percent
of independent laboratories would account for approximately 99 percent
of CLFS spending on independent laboratories (81 FR 41051).
We stated that it is our understanding that physician offices are
generally not prepared to identify, collect, and report each unique
private payor rate from each private payor for each laboratory test
code subject to the data collection and reporting requirements, and the
volume associated with each unique private payor rate. As such, we
explained that we believe revising the low expenditure threshold so
that more physician office laboratories are required to report
applicable information would likely impose significant administrative
burdens on physician offices. We stated that we also believe that
increasing participation from physician office laboratories would have
minimal overall impact on payment rates given that the weighted median
of private payor rates is dominated by the laboratories with the
largest test volume. We noted that our participation simulations from
the first data reporting period show that increasing the volume of
physician office laboratories reporting applicable information has
minimal overall impact on the weighted median of private payor rates.
For more information on our participation simulations, please visit the
CLFS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-
Payment/ClinicalLabFeeSched/Downloads/CY2018-CLFS-Payment-System-
Summary-Data.pdf.
We stated in the proposed rule that we continue to believe the
current low expenditure threshold strikes an appropriate balance
between collecting enough private payor rate data to accurately
represent the weighted median of private payor rates while limiting the
administrative burden on small laboratories. In addition, as discussed
previously in this section, we are finalizing excluding MA plan
revenues under Part C from total Medicare revenues in the definition of
applicable laboratory, and we noted that we expect more laboratories of
all types, including physician office laboratories, may meet the
majority of Medicare revenues threshold.
However, we recognized from stakeholders that some physician office
laboratories and small independent laboratories that are not applicable
laboratories because they do not meet the current low expenditure
threshold may still want to report applicable information despite the
administrative burden associated with qualifying as an applicable
laboratory. Therefore, we sought public comment on revising the low
expenditure threshold to increase the level of participation among
physician office laboratories and small independent laboratories.
In the proposed rule we explained that one approach could be for us
to decrease the low expenditure threshold by 50 percent, from $12,500
to $6,250, in CLFS revenues during a data collection period. Under such
an approach, a laboratory would need to receive at least $6,250 in CLFS
revenues in a data collection period. We stated that if we were to
adopt such an approach, we would need to revise paragraph (4) of the
definition of applicable laboratory at Sec. 414.502 to replace $12,500
with $6,250. We solicited public comments on this approach.
We noted that we were particularly interested in comments from the
physician community and small independent laboratories as to the
administrative burden associated with such a revision to the low
expenditure threshold. Specifically, we requested comments on the
following issues: (1) Whether physician offices and small independent
laboratories currently have adequate staff levels to meet the data
collection and data reporting requirements; (2) whether data systems
are currently in place to identify, collect, and report each unique
private payor rate from each private payor for each CLFS test code and
the volume of tests associated with each unique private payor rate; (3)
if physician offices and small independent laboratories are generally
not prepared to conduct the data collection and data reporting
requirements, what is the anticipated timeframe needed for physician
office and small independent laboratories to be able to meet the data
collection and data reporting requirements; and (4) any other
administrative concerns that decreasing the low expenditure threshold
may impose on offices and small independent laboratories.
The following is a summary of the comments we received and our
responses to the comments regarding the approach of decreasing the low
expenditure threshold by 50 percent, from $12,500 to $6,250, in CLFS
revenues during a data collection period.
Comment: Many commenters were opposed to reducing the low
expenditure threshold because of the administrative burden it would
place on physician office laboratories and small independent
laboratories. Commenters noted that they experienced difficulties
during the initial data collection and data reporting period with
determining whether they met the definition of applicable laboratory
and therefore if they were required to report applicable information.
Some commenters that did report applicable information stated that they
experienced significant administrative burden in collecting and
compiling information, especially for test codes that involved numerous
different sources of payment (such as the beneficiary's primary private
payor, the beneficiary's secondary insurance, and coinsurance
requirements). Some commenters reported having to remove staff from
regular duties to work full time on preparing to report applicable
information to CMS. A few commenters noted that physician office
laboratories and small independent laboratories do not have the
staffing or resources currently available, nor do they anticipate
having them available in the future, to identify, collect and report
each unique private payor rate for each CLFS test code and the volume
of tests associated with each unique private payor rate. As such,
commenters encouraged CMS not to decrease the low expenditure threshold
component of the definition of applicable laboratory.
Response: We appreciate the comments regarding the administrative
burden imposed by the data collection and reporting requirements on
physician office laboratories and small independent laboratories and
understand that reducing the low expenditure threshold by 50 percent
would add more burden on this segment of the laboratory industry. We
will consider the commenters' input regarding the low expenditure
threshold as we continue to evaluate and refine Medicare CLFS payment
policy in the future.
Comment: A few commenters suggested alternative approaches to
lowering the low expenditure threshold that involve collecting data for
physician office dependent tests and allowing laboratories to
voluntarily report applicable information. For example, two commenters
suggested that CMS identify laboratory tests predominantly performed by
physician office laboratories and collect a statistically
representative sample of data from physician office laboratories for
the range of tests commonly performed in this setting. Under the
commenters' approach, physician office laboratories would be required
to report those tests. The commenters stated that this would ensure
that the private payor rates for tests mostly performed by physician
office laboratories are

[[Page 59679]]

represented in the weighted median of private payor rates used to
determine CLFS rates. Moreover, a few other commenters suggested that
CMS permit voluntary reporting so that laboratories that do not meet
the current low expenditure threshold may report applicable information
if they choose to.
Response: The suggestions to identify physician office laboratory
dependent tests and to permit voluntary reporting have already been
addressed in previous rulemaking and we chose not to adopt them (81 FR
41048). We noted that statute is clear about the particular information
that is to be reported and on which we must base the new CLFS payment
rates. Only applicable information of applicable laboratories is to be
reported, and section 1834A(a)(3) of the Act indicates that applicable
information is private payor rate information. We also explained that
the statute imposes parameters on the collection and reporting of
private payor rate information, and section 1834A(b) of the Act
specifies that the payment amounts for CDLTs are to be based on the
median of the private payor rate information. As such, we stated that
we believe the statute supports our policy to prohibit information
other than statutorily specified private payor rate information of
applicable laboratories from being reported and used to set CLFS
payment amounts under the revised CLFS. We also noted that we did not
agree with the commenters' recommendation to allow voluntary reporting
and at Sec. 414.504(g), we finalized that an entity that does not meet
the definition of an applicable laboratory may not report applicable
information. We continue to believe that our policy to not allow
voluntary reporting is the most appropriate interpretation of the
statute, and that applicable information may not be reported for an
entity that does not meet the definition of an applicable laboratory.
b. Increasing the Low Expenditure Threshold
We also discussed in the CY 2019 PFS proposed rule that we
recognize many small laboratories may not want the additional
administrative burden of data collection and reporting and, because
their test volume is relatively low, their data is unlikely to have a
meaningful impact on the weighted median of private payor rates for
CDLTs under the CLFS. In response to comments from smaller laboratories
that they prefer to not be applicable laboratories because of the
burden of collecting and reporting applicable information, we stated
that we could increase the low expenditure threshold in the definition
of applicable laboratory by 50 percent, from $12,500 to $18,750, in
CLFS revenues during a data collection period. Because physician office
laboratories would be less likely to meet a higher threshold, such an
approach would decrease the number of physician office laboratories and
small independent laboratories required to collect and report
applicable information. We noted that we expected decreasing the number
of physician office laboratories and small independent laboratories
reporting applicable information would have minimal impact on
determining CLFS rates because the largest laboratories with the
highest test volumes dominate the weighted median of private payor
rates.
We stated that if we were to adopt such an approach, we would need
to revise paragraph (4) of the definition of applicable laboratory at
Sec. 414.502 to replace $12,500 with $18,750. We explained in the
proposed rule that we were particularly interested in comments from the
physician community and small independent laboratories on the
administrative burden and relief of increasing the low expenditure
threshold and noted that we believe that feedback on the topics
discussed in this section would help inform us regarding potential
refinements to the low expenditure threshold. We noted that depending
on the comments we received, we would consider approaches described in
this section.
The following is a summary of the comments we received and our
responses to the comments regarding the approach of increasing the low
expenditure threshold by 50 percent, from $12,500 to $18,750, in CLFS
revenues during a data collection period.
Comment: Several commenters did not support raising the low
expenditure threshold because it would further reduce the amount of
applicable information reported from small laboratories. However, one
commenter encouraged CMS to increase the low expenditure threshold to
exclude even more small laboratories from the administrative burden of
collecting and reporting applicable information. A few commenters
suggested that CMS not make any changes to the low expenditure
threshold at this time and encouraged CMS to allow the program to
mature and to only make changes after a careful and transparent review
of the data with additional opportunities for public comment.
Response: We appreciate the comments from stakeholders on raising
the low expenditure threshold and understand that increasing the low
expenditure threshold by 50 percent would lead to fewer physician
office laboratories and small independent laboratories from reporting
applicable information for purposes of calculating CLFS rates. We will
consider the commenters input on increasing the low expenditure
threshold as we continue to evaluate and refine Medicare CLFS payment
policy in the future, but make no changes to this policy at this time.
c. Additional Comments Received
Comment: Many commenters stated that CMS' implementation of the new
private payor rate-based CLFS does not reflect the cost or the value of
performing clinical laboratory services and that without meaningful
changes to how data is collected from laboratories, Medicare
beneficiaries will lose access to the vital laboratory services they
rely on to monitor their health and prevent and treat many diseases and
conditions. The commenters stated that CMS' regulations, which
implemented the private payor rate-based CLFS required under PAMA,
prohibit most independent laboratories and physician office
laboratories, and virtually all hospital laboratories, from providing
data to set Medicare rates, and therefore, results in ``skewed data''
that does not represent true market rates. The commenters stated that
Congress directed CMS to implement a market-based payment system in
which private market data from all segments of the laboratory industry,
including independent laboratories, hospital laboratories, and
physician office laboratories, would be collected in order to determine
Medicare reimbursement for laboratory tests. To implement a true market
based payment system the commenters encouraged CMS to develop payment
rates through a statistically valid process to ensure that the private
payer data collected accurately represents all sectors of the
laboratory market.
Response: In general, section 1834A of the Act requires the payment
amount for each CDLT on the CLFS to be based on the applicable
information collected from applicable laboratories during a data
collection period and reported to CMS during a data reporting period.
For most tests on the CLFS, the statute requires the payment amount to
be equal to the weighted median of the private payor rates for each
test and specifies that the weighted median is calculated by arraying
the distribution of all private payor rates, weighted by the volume for
each payor and each laboratory. Given that the largest

[[Page 59680]]

laboratories reported their applicable information to CMS in the
initial data reporting period, as well as many smaller laboratories, we
believe the data we used to calculate the CY 2018 CLFS rates was
sufficient and resulted in accurate weighted medians of private payor
rates per test as required by the statute. As discussed previously in
this section, we are finalizing our proposal to exclude MA plan
payments under Part C from total Medicare revenues for purposes of the
applicable laboratory definition. We believe this change will permit
laboratories of all types with a significant Medicare Part C revenue
component to be more likely to meet the majority of Medicare revenues
threshold and qualify as an applicable laboratory. As a result of this
change, we believe that applicable information from a broader segment
of the laboratory industry will be reported for purposes of calculating
the CLFS rates. As stated previously, we are finalizing the use of the
Form CMS-1450 14x TOB to define applicable laboratories, subject to
other regulatory and subregulatory requirements, such as the regulatory
low expenditure threshold.
Comment: One commenter stated that the reductions in Medicare
payment rates for laboratory tests result directly from CMS' regulatory
decisions to relieve most laboratories of reporting burdens. According
to the commenter, excluding so many laboratories from the data
reporting requirements results in median prices that are not
representative across the clinical laboratory industry. As such, the
commenter noted that the market data upon which Medicare reimbursement
is based does not reflect the market composition of the clinical
laboratory industry. In other words, exempting low-volume and many
hospital laboratories from reporting does not allow for Medicare prices
to reflect the full range of payment amounts paid to varying entities.
The commenter encouraged CMS to collect data from a broader segment of
the laboratory industry and suggested that we weight private payor
rates by market share (that is, prices typically paid per reporting
entity), instead of based on overall volume per test.
Response: As discussed in response to the previous comment, section
1834A of the Act generally requires the payment amount for each CDLT on
the CLFS to be based on the applicable information collected from
applicable laboratories during a data collection period and reported to
CMS during a data reporting period. Because for most tests, the payment
amount is equal to the median of the private payor rates weighted by
volume, the largest laboratories with the highest test volumes will
most significantly affect the payment rates. Because of this, we
established and implemented a low expenditure threshold to alleviate
administrative burden on small laboratories. We believe that our
current method of calculating the weighted median of private payor
rates is appropriate and consistent with the statute. Given that the
largest laboratories reported their applicable information to us in the
initial data reporting period, along with many smaller laboratories, we
believe the data we used to calculate the CY 2018 CLFS rates was
sufficient and resulted in accurate weighted medians of private payor
rates as required by statute. As noted above, we are finalizing changes
to the definition of an applicable laboratory, which we believe will
lead to an even more robust data collection from which to calculate
payment rates for the next CLFS update.
Comment: Many commenters stated that the administrative burden for
the first data reporting period was overwhelming and they offered
suggestions on how to reduce the reporting burden on applicable
laboratories. Many commenters suggested that CMS implement a ``data
aggregation system'' consistent with statutory authority. In addition,
a few commenters requested that CMS allow flexibility to exclude manual
remittances from the definition of applicable information and therefore
from data reporting. One commenter requested an ``across the board
waiver'' from the reporting requirement for all small medical
practices.
Response: We addressed the comment requesting exclusion of manual
remittances from the definition of applicable information in the CLFS
final rule (81 FR 41053 through 41054). We explained that the statute
is clear that applicable information, which is used to set CLFS payment
amounts, must be reported for applicable laboratories for a data
collection period, and it defines applicable information, in part, as
the payment rate that was paid by each private payor for the test
during a data collection period and the volume of such tests for each
such payor for the data collection period. As such, we stated that we
believe the statute does not support selective reporting of applicable
information for applicable laboratories. If the laboratory meets the
definition of applicable laboratory, the applicable information for
that laboratory must be reported. In addition, given that the statute
requires applicable information to be reported for applicable
laboratories, we do not believe granting an ``across the board waiver''
from the reporting requirements for all small laboratories would be
consistent with statute. We believe that the low expenditure threshold
would continue to exclude the majority of small laboratories from the
applicable laboratory definition and, therefore, from data reporting.
With regard to the commenters suggesting that we implement
aggregate reporting, we note that section 1834A(a)(6) of the Act
permits the Secretary, beginning with January 1, 2019, to establish
rules to aggregate reporting in situations where an applicable
laboratory has more than one payment rate for the same payor for the
same test or more than one payment rate for different payors for the
same test. While the agency did not propose or solicit comments on
implementing aggregate data reporting, we will take the commenters'
suggestion into consideration for future refinements to the CLFS.
However, to help reduce administrative burden for the next data
reporting period, we will allow reporting entities the option to
condense certain applicable information at the TIN-level, instead of
reporting for each applicable laboratory individually at the NPI level.
We will provide more information regarding the condensed reporting
option through subregulatory guidance during the next data collection
period.
Comment: One commenter suggested that CMS adopt a 90-day data
collection period instead of the current 6-month data collection period
to alleviate some of the burden associated with collecting applicable
information.
Response: While we did not propose or solicit comments on changing
the data collection period, we will take the commenter's suggestion
into consideration for future refinements to the CLFS.
Comment: One commenter raised concerns about the integrity of the
data reported during the first data reporting period. The commenter
mentioned that the CLFS final rule was released just prior to the end
of the first data collection period and as a result, laboratories
struggled to collect information and submit the required data
accurately. The commenter noted that many laboratories still do not
have the systems in place to determine the private payor payment rates
for each test and the associated volume paid at each rate, therefore
exacerbating the potential for inaccurate reporting in the next data
reporting period. The commenter was particularly concerned about how
inaccurate data affects newer tests in which the volume of services has

[[Page 59681]]

remained relatively low as compared to well established laboratory
procedures. For instance, because of the low volume of applicable
information being reported for Tier 1 and Tier 2 molecular pathology
procedures, the commenter stated that any inaccurate data reported has
a greater impact on these test codes. The commenter noted that
expanding the definition of an applicable laboratory would likely
result in additional reporting errors and therefore, did not support
any revisions to the definition of an applicable laboratory. Instead,
the commenter urged CMS to refine the reporting process and implement
measures to safeguard data integrity in future reporting periods.
Specifically, the commenter requested that CMS consider implementing a
data aggregation system for future data reporting periods, consistent
with statutory authority. The commenter noted that a data aggregation
system may guarantee more complete reporting and expand the ability of
laboratories to report accurate data.
Response: We share the commenter's interest in collecting accurate
data. As discussed previously, we are finalizing changes to the
definition of applicable laboratory in Sec. 414.502. We did not
propose changes to the CLFS data reporting requirements or solicit
comments on how to safeguard against inaccurate data. We will consider
the issues raised by the commenter for future rulemaking. As noted in
response to another comment, for the next data reporting period we will
permit the reporting entity to condense applicable information for its
applicable laboratories at the TIN level, instead of reporting for each
of its applicable laboratories individually, and will issue
subregulatory guidance on this topic.
Comment: One commenter stated that in general ``our market based
system is flawed'' because it allows companies to profit on people's
health. The commenter stated that the CLFS should be based on
recovering costs only and not profit. The commenter noted that such
approach will lead to a decrease in cost for laboratory testing and a
standardization of fees across the industry.
Response: As previously noted, section 1834A of the Act generally
requires the payment amount for each CDLT on the CLFS to be based on
the applicable information collected from applicable laboratories
during a data collection period and reported to us during a data
reporting period. Basing CLFS rates on laboratory costs would not be
permissible under the statute.
Comment: One commenter stated that uncertainty regarding the
definition of an ADLT has discouraged some laboratories from applying
for ADLT status, and suggested that we should implement the regulatory
requirements in a manner that ``recognizes the uniqueness of the
results generated by each precision diagnostic test due to its use of a
proprietary algorithm validated in a unique patient cohort.''
Response: We did not propose or solicit any comments regarding
changes to the definition of an ADLT, therefore, this comment is not
within the scope of this rulemaking.

B. Changes to the Regulations Associated With the Ambulance Fee
Schedule

1. Overview of Ambulance Services
a. Ambulance Services
Under the ambulance fee schedule, the Medicare program pays for
ambulance transportation services for Medicare beneficiaries under
Medicare Part B when other means of transportation are contraindicated
by the beneficiary's medical condition and all other coverage
requirements are met. Ambulance services are classified into different
levels of ground (including water) and air ambulance services based on
the medically necessary treatment provided during transport.
These services include the following levels of service:
For Ground--

++ Basic Life Support (BLS) (emergency and non-emergency).
++ Advanced Life Support, Level 1 (ALS1) (emergency and non-
emergency).
++ Advanced Life Support, Level 2 (ALS2).
++ Paramedic ALS Intercept (PI).
++ Specialty Care Transport (SCT).

For Air--

++ Fixed Wing Air Ambulance (FW).
++ Rotary Wing Air Ambulance (RW).
b. Statutory Coverage of Ambulance Services
Under sections 1834(l) and 1861(s)(7) of the Act, Medicare Part B
(Supplemental Medical Insurance) covers and pays for ambulance
services, to the extent prescribed in regulations, when the use of
other methods of transportation would be contraindicated by the
beneficiary's medical condition.
The House Ways and Means Committee and Senate Finance Committee
Reports that accompanied the 1965 Social Security Amendments suggest
that the Congress intended that--
The ambulance benefit cover transportation services only
if other means of transportation are contraindicated by the
beneficiary's medical condition; and
Only ambulance service to local facilities be covered
unless necessary services are not available locally, in which case,
transportation to the nearest facility furnishing those services is
covered (H.R. Rep. No. 213, 89th Cong., 1st Sess. 37 and Rep. No. 404,
89th Cong., 1st Sess. Pt 1, 43 (1965)).
The reports indicate that transportation may also be provided from
one hospital to another, to the beneficiary's home, or to an extended
care facility.
c. Medicare Regulations for Ambulance Services
The regulations relating to ambulance services are set forth at 42
CFR part 410, subpart B, and 42 CFR part 414, subpart H. Section
410.10(i) lists ambulance services as one of the covered medical and
other health services under Medicare Part B. Therefore, ambulance
services are subject to basic conditions and limitations set forth at
Sec. 410.12 and to specific conditions and limitations included at
Sec. Sec. 410.40 and 410.41. Subpart H of part 414 describes how
payment is made for ambulance services covered by Medicare Part B.
2. Ambulance Extender Provisions
a. Amendment to Section 1834(l)(13) of the Act
Section 146(a) of the Medicare Improvements for Patients and
Providers Act of 2008 (MIPPA), (Pub. L. 110-275, enacted July 15, 2008)
amended section 1834(l)(13)(A) of the Act to specify that, effective
for ground ambulance services furnished on or after July 1, 2008, and
before January 1, 2010, the ambulance fee schedule amounts for ground
ambulance services shall be increased as follows:
For covered ground ambulance transports that originate in
a rural area or in a rural census tract of a metropolitan statistical
area, the fee schedule amounts shall be increased by 3 percent.
For covered ground ambulance transports that do not
originate in a rural area or in a rural census tract of a metropolitan
statistical area, the fee schedule amounts shall be increased by 2
percent.
The payment add-ons under section 1834(l)(13)(A) of the Act have
been extended several times. Most recently, section 50203(a)(1) of the
Bipartisan Budget Act of 2018 (BBA) (Pub. L. 115-123, enacted February
9, 2018) amended section 1834(l)(13)(A) of the Act to extend the
payment add-ons through

[[Page 59682]]

December 31, 2022. Thus, these payment add-ons apply to covered ground
ambulance transports furnished before January 1, 2023. We proposed to
revise Sec. 414.610(c)(1)(ii) to conform the regulations to this
statutory requirement. (For further information regarding the
implementation of this provision for claims processing, please see CR
10531. For a discussion of past legislation extending section
1834(l)(13) of the Act, please see the CY 2014 PFS final rule with
comment period (78 FR 74438 through 74439), the CY 2015 PFS final rule
with comment period (79 FR 67743) and the CY 2016 PFS final rule with
comment period (80 FR 71071 through 71072)).
This statutory requirement is self-implementing. A plain reading of
the statute requires only a ministerial application of the mandated
rate increase, and does not require any substantive exercise of
discretion on the part of the Secretary.
We received two comments on this proposal. The following is a
summary of those comments along with our response.
Comment: One commenter supported the 5-year extension of the add-on
payments and appreciates CMS' implementation of the statutory
requirement, and stated these provisions are critical to ensuring the
delivery of ambulance services. Another commenter stated that due to
the staffing and distances that might be involved in the use of
ambulance services in varying areas (for example, urban, rural and
super rural), these add-ons payments will assist in appropriate
reimbursements for these services.
Response: We appreciate the commenters' support.
After consideration of the comments received, we are finalizing our
proposal, without modification, to revise Sec. 414.610(c)(1)(ii) to
conform the regulations to this statutory requirement.
b. Amendment to Section 1834(l)(12) of the Act
Section 414(c) of the Medicare Prescription Drug, Improvement and
Modernization Act of 2003 (Pub. L. 108-173, enacted December 8, 2003)
(MMA) added section 1834(l)(12) to the Act, which specified that, in
the case of ground ambulance services furnished on or after July 1,
2004, and before January 1, 2010, for which transportation originates
in a qualified rural area (as described in the statute), the Secretary
shall provide for a percent increase in the base rate of the fee
schedule for such transports. The statute requires this percent
increase to be based on the Secretary's estimate of the average cost
per trip for such services (not taking into account mileage) in the
lowest quartile of all rural county populations as compared to the
average cost per trip for such services (not taking into account
mileage) in the highest quartile of rural county populations. Using the
methodology specified in the July 1, 2004 interim final rule (69 FR
40288), we determined that this percent increase was equal to 22.6
percent. As required by the MMA, this payment increase was applied to
ground ambulance transports that originated in a ``qualified rural
area,'' that is, to transports that originated in a rural area included
in those areas comprising the lowest 25th percentile of all rural
populations arrayed by population density. For this purpose, rural
areas included Goldsmith areas (a type of rural census tract). This
rural bonus is sometimes referred to as the ``Super Rural Bonus'' and
the qualified rural areas (also known as ``super rural'' areas) are
identified during the claims adjudicative process via the use of a data
field included in the CMS-supplied ZIP code file.
The Super Rural Bonus under section 1834(l)(12) of the Act has been
extended several times. Most recently, section 50203(a)(2) of the BBA
amended section 1834(l)(12)(A) of the Act to extend this rural bonus
through December 31, 2022. Therefore, we are continuing to apply the
22.6 percent rural bonus described in this section (in the same manner
as in previous years) to ground ambulance services with dates of
service before January 1, 2023 where transportation originates in a
qualified rural area. Accordingly, we proposed to revise Sec.
414.610(c)(5)(ii) to conform the regulations to this statutory
requirement. (For further information regarding the implementation of
this provision for claims processing, please see CR 10531. For a
discussion of past legislation extending section 1834(l)(12) of the
Act, please see the CY 2014 PFS final rule with comment period (78 FR
74439 through 74440), CY 2015 PFS final rule with comment period (79 FR
67743 through 67744) and the CY 2016 PFS final rule with comment period
(80 FR 71072)).
This statutory provision is self-implementing. It requires an
extension of this rural bonus (which was previously established by the
Secretary) through December 31, 2022, and does not require any
substantive exercise of discretion on the part of the Secretary.
We received two comments on this proposal. The following is a
summary of those comments along with our response.
Comment: One commenter supported the 5-year extension of this
provision and appreciates CMS' implementation of the statutory
requirement and noted this provision is critical to ensuring the
delivery of ambulance services. Another commenter stated that due to
the staffing and distances that might be involved in the use of
ambulance services in varying areas (for example, urban, rural and
super rural), these add-ons payments will assist in appropriate
reimbursements for these services.
Response: We appreciate the commenters' support.
After consideration of the comments received, we are finalizing our
proposal, without modification, to revise Sec. 414.610(c)(5)(ii) to
conform the regulations to this statutory requirement.
3. Amendment to Section 1834(l)(15) of the Act
Section 637 of the American Taxpayer Relief Act of 2012 (ATRA)
(Pub. L. 112-240, enacted January 2, 2013) added section 1834(l)(15) of
the Act to specify that the fee schedule amount otherwise applicable
under the preceding provisions of section 1834(l) of the Act shall be
reduced by 10 percent for ambulance services furnished on or after
October 1, 2013, consisting of non-emergency BLS services involving
transport of an individual with end-stage renal disease for renal
dialysis services (as described in section 1881(b)(14)(B) of the Act)
furnished other than on an emergency basis by a provider of services or
a renal dialysis facility. In the CY 2014 PFS final rule with comment
period (78 FR 74440), we revised Sec. 414.610 by adding paragraph
(c)(8) to conform the regulations to this statutory requirement.
Section 53108 of the BBA amended section 1834(l)(15) of the Act to
increase the reduction from 10 percent to 23 percent effective for
ambulance services (as described in section 1834(l)(15) of the Act)
furnished on or after October 1, 2018. The 10 percent reduction applies
for ambulance services (as described in section 1834(l)(15) of the Act)
furnished during the period beginning on October 1, 2013 and ending on
September 30, 2018. Accordingly, we proposed to revise Sec.
414.610(c)(8) to conform the regulations to this statutory requirement.
This statutory requirement is self-implementing. A plain reading of
the statute requires only a ministerial application of the mandated
rate decrease, and does not require any substantive exercise of
discretion on the part of the Secretary. Accordingly, for ambulance
services described in section

[[Page 59683]]

1834(l)(15) of the Act furnished during the period beginning on October
1, 2013 and ending on September 30, 2018, the fee schedule amount
otherwise applicable (both base rate and mileage) is reduced by 10
percent, and for ambulance services described in section 1834(l)(15) of
the Act furnished on or after October 1, 2018, the fee schedule amount
otherwise applicable (both base rate and mileage) is reduced by 23
percent. (For further information regarding application of this
mandated rate decrease, please see CR 10549.)
We received two comments on this proposal. The following is a
summary of those comments along with our response.
Comment: One commenter supported the reduction of payment for these
ambulance services and stated that the payment adjustment for non-
emergency, BLS transports for ESRD beneficiaries is at an appropriate
level. Another commenter stated that for accountable care
organizations, transportation for dialysis services constitutes the
largest portion of ambulance spending. According to the commenter,
because patients often do not receive medical care during the
transportation, they supported the reduction to the ambulance fee
schedule for the transportation of patients with ESRD for renal
dialysis services.
Response: We appreciate the commenters' support.
After consideration of the comments received, we are finalizing our
proposal, without modification, to revise Sec. 414.610(c)(8) to
conform the regulations to the statutory requirement described above.

C. Rural Health Clinics (RHCs) and Federally Qualified Health Centers
(FQHCs)

1. Payment for Care Management Services
In the CY 2018 PFS final rule, we revised the payment methodology
for Chronic Care Management (CCM) services furnished by RHCs and FQHCs,
and established requirements and payment for general Behavioral Health
Integration (BHI) and psychiatric Collaborative Care Management (CoCM)
services furnished in RHCs and FQHCs, beginning on January 1, 2018.
For CCM services furnished by RHCs or FQHCs between January 1,
2016, and December 31, 2017, payment is at the PFS national average
payment rate for CPT 99490. For CCM, general BHI, and psychiatric CoCM
services furnished by RHCs or FQHCs on or after January 1, 2018, we
established 2 new HCPCS codes. The first HCPCS code, G0511, is a
General Care Management code for use by RHCs or FQHCs when at least 20
minutes of qualified CCM or general BHI services are furnished to a
patient in a calendar month. The second HCPCS code, G0512, is a
psychiatric CoCM code for use by RHCs or FQHCs when at least 70 minutes
of initial psychiatric CoCM services or 60 minutes of subsequent
psychiatric CoCM services are furnished to a patient in a calendar
month.
The payment amount for HCPCS code G0511 is set at the average of
the 3 national non-facility PFS payment rates for the CCM and general
BHI codes and updated annually based on the PFS amounts. The 3 codes
are CPT 99490 (20 minutes or more of CCM services), CPT 99487 (60
minutes or more of complex CCM services), and CPT 99484 (20 minutes or
more of BHI services).
The payment amount for HCPCS code G0512 is set at the average of
the 2 national non-facility PFS payment rates for CoCM codes and
updated annually based on the PFS amounts. The 2 codes are CPT 99492
(70 minutes or more of initial psychiatric CoCM services) and CPT 99493
(60 minutes or more of subsequent psychiatric CoCM services).
For practitioners billing under the PFS, we proposed for CY 2019 a
new CPT code, 994X7, which would correspond to 30 minutes or more of
CCM furnished by a physician or other qualified health care
professional and is similar to CPT codes 99490 and 99487. For RHCs and
FQHCs, we proposed to add CPT code 994X7 as a general care management
service and to include it in the calculation of HCPCS code G0511. That
is, we proposed that starting on January 1, 2019, RHCs and FQHCs would
be paid for HCPCS code G0511 based on the average of the national non-
facility PFS payment rates for CPT codes 99490, 99487, 99484, and
994X7. We note that CPT code 994X7 was a placeholder code, and the
final code is CPT code 99491.
We proposed to revise Sec. 405.2464 to reflect the current payment
methodology that was finalized in the CY 2018 PFS and incorporate the
addition of the new CPT code to HCPCS code G0511.
2. Communication Technology-Based and Remote Evaluation Services
RHC and FQHC visits are face-to-face (in-person) encounters between
a patient and an RHC or FQHC practitioner during which time one or more
RHC or FQHC qualifying services are furnished. RHC and FQHC
practitioners are physicians, nurse practitioners, physician
assistants, certified nurse midwives, clinical psychologists, and
clinical social workers, and under certain conditions, a registered
nurse or licensed practical nurse furnishing care to a homebound RHC or
FQHC patient. A Transitional Care Management service can also be an RHC
or FQHC visit. A Diabetes Self-Management Training (DSMT) service or a
Medical Nutrition Therapy (MNT) service furnished by a certified DSMT
or MNT provider may also be an FQHC visit.
RHCs are paid an all-inclusive rate (AIR) for medically-necessary,
face-to-face visits with an RHC practitioner. The rate is subject to a
payment limit, except for those RHCs that have an exception to the
payment limit for being ``provider-based'' (see Sec. 413.65). FQHCs
are paid the lesser of their charges or the FQHC Prospective Payment
System (PPS) rate for medically-necessary, face-to-face visits with an
FQHC practitioner. Only medically-necessary medical, mental health, or
qualified preventive health services that require the skill level of an
RHC or FQHC practitioner can be RHC or FQHC billable visits.
The RHC and FQHC payment rates reflect the cost of all services and
supplies that an RHC or FQHC furnishes to a patient in a single day,
and are not adjusted for the complexity of the patient health care
needs, the length of the visit, or the number or type of practitioners
involved in the patient's care.
Services furnished by auxiliary personnel (such as nurses, medical
assistants, or other clinical personnel acting under the supervision of
the RHC or FQHC practitioner) are considered incident to the visit and
are included in the per-visit payment. This may include services
furnished prior to or after the billable visit that occur within a
medically appropriate time period, which is usually 30 days or less.
RHCS and FQHCs are also paid for care management services,
including chronic care management services, general behavioral health
integration services, and psychiatric Collaborative Care Model
services. These are typically non-face-to-face services that do not
require the skill level of an RHC or FQHC practitioner and are not
included in the RHC or FQHC payment methodologies.
For practitioners billing under the PFS, we proposed for CY 2019
separate payment for certain communication technology-based services.
This includes what is referred to as ``Brief Communication Technology-
Based Services'' for a ``virtual check-in'' and separate payment for
remote evaluation of recorded video and/or images. The ``virtual check-
in'' visit would be

[[Page 59684]]

billable when a physician or non-physician practitioner has a brief (5
to 10 minutes), non-face-to-face check in with a patient via
communication technology to assess whether the patient's condition
necessitates an office visit. This service could be billed only in
situations where the medical discussion was for a condition not related
to an E/M service provided within the previous 7 days, and does not
lead to an E/M service or procedure within the next 24 hours or at the
soonest available appointment. We also proposed payment for
practitioners billing under the PFS for remote evaluation services.
This payment would be for the remote evaluation of patient-transmitted
information conducted via pre-recorded ``store and forward'' video or
image technology, including interpretation with verbal follow-up with
the patient within 24 business hours, not originating from a related E/
M service provided within the previous 7 days nor leading to an E/M
service or procedure within the next 24 hours or soonest available
appointment. We stated that both of these services would be priced
under the PFS at a rate that reflects the resource costs of these non-
face-to-face services relative to other PFS services, including face-
to-face and in-person visits.
The RHC and FQHC payment models are distinct from the PFS model in
that the payment is for a comprehensive set of services and supplies
associated with an RHC or FQHC visit. A direct comparison between the
payment for a specific service furnished in an RHC or FQHC and the same
service furnished in a physician's office is not possible, because the
payment for RHCs and FQHCs is a per diem payment that includes the cost
for all services and supplies rendered during an encounter, and payment
for a service furnished in a physician's office and billed under the
PFS is only for that service.
We recognize that there are occasions when it may be beneficial to
both the patient and the RHC or FQHC to utilize communication
technology-based services to determine the course of action for a
health issue. Currently under the RHC and FQHC payment systems, if the
communication results in a face-to-face billable visit with an RHC or
FQHC practitioner, the cost of the prior communication would be
included in the RHC AIR or the FQHC PPS. However, if as a result of the
communication it is determined that a visit is not necessary, there
would not be a billable visit and there would be no payment.
RHCs and FQHCs furnish services in rural and urban areas that have
been determined to be medically underserved areas or health
professional shortage areas. They are an integral component of the
Nation's health care safety net, and we want to ensure that Medicare
patients who are served by RHCs and FQHCs are able to communicate with
their RHC or FQHC practitioner in a manner that enhances access to
care, consistent with evolving medical care. Particularly in rural
areas where transportation is limited and distances may be far, we
believe the use of communication technology-based services may help
some patients to determine if they need to schedule a visit at the RHC
or FQHC. If it is determined that a visit is not necessary, the RHC or
FQHC practitioner would be available for other patients who need their
care.
When communication technology-based services are furnished in
association with an RHC or FQHC billable visit, the costs of these
services are included in the RHC AIR or the FQHC PPS and are not
separately billable. However, if there is no RHC or FQHC billable
visit, these costs are not paid as part of an RHC AIR or FQHC PPS
payment. We therefore proposed that, effective January 1, 2019, RHCs
and FQHCs receive an additional payment for the costs of communication
technology-based services or remote evaluation services that are not
already captured in the RHC AIR or the FQHC PPS payment when the
requirements for these services are met.
We proposed that RHCs and FQHCs receive payment for communication
technology-based or remote evaluation services when at least 5 minutes
of communication technology-based or remote evaluation services are
furnished by an RHC or FQHC practitioner to a patient who has been seen
in the RHC or FQHC within the previous year. These services may only be
billed when the medical discussion or remote evaluation is for a
condition not related to an RHC or FQHC service provided within the
previous 7 days, and does not lead to an RHC or FQHC service within the
next 24 hours or at the soonest available appointment, since in those
situations the services are already paid as part of the RHC or FQHC
per-visit payment.
We proposed to create a new virtual communication G-code for use by
RHCs and FQHCs only, with a payment rate set at the average of the PFS
national non-facility payment rates for HCPCS code GVCI1 for
communication technology-based services, and HCPCS code GRAS1 for
remote evaluation services. RHCs and FQHCs would be able to bill the
virtual communication G-code either alone or with other payable
services. The payment rate for the virtual communication G-code would
be updated annually based on the PFS amounts. We note that HCPCS codes
GCVI1 and GRAS1 were placeholder codes, and the final HCPCS codes are
G2012 and G2010, respectively.
We also proposed to waive the RHC and FQHC face-to-face
requirements when these services are furnished to an RHC or FQHC
patient. Coinsurance would be applied to FQHC claims, and coinsurance
and deductibles would apply to RHC claims for these services. Services
that are currently being furnished and paid under the RHC AIR or FQHC
PPS payment methodology will not be affected by the ability of the RHC
or FQHC to receive payment for additional services that are not
included in the RHC AIR or FQHC PPS.
3. Other Options Considered
We considered other options for payment for these services. First,
we considered adding communication technology-based and remote
evaluation services as an RHC or FQHC stand-alone service. Under this
option, payment for RHCs would be at the AIR, and payment for FQHCs
would be the lesser of total charges or the PPS rate. We did not
propose this payment option because these services do not meet the
requirements for an RHC or FQHC billable visit and payment at the RHC
AIR or FQHC PPS would result in a payment rate incongruent with
efficiencies inherent in the provision of the technology-based
services.
The second option we considered was to allow RHCs and FQHCs to bill
HCPCS codes G2012 or G2010 separately on an RHC or FQHC claim. We did
not propose this payment option because we believe that a combined G-
code is less burdensome and will allow expansion of these services
without adding additional codes on an RHC or FQHC claim.
4. Comments and Responses
We invited comments on this proposal. In particular, we were
interested in comments regarding the appropriateness of payment for
communication technology-based and remote evaluation services in the
absence of an RHC or FQHC visit, the burden associated with
documentation for billing these codes (RHC or FQHC practitioner's time,
medical records, etc.), and any potential impact on the per diem nature
of RHC and FQHC billing and payment structure as a result of payment
for these services.

[[Page 59685]]

The following is a summary of the comments we received regarding
the addition of CPT code 99491 to the codes used to determine the
payment for HCPCS code G0511 in RHCs and FQHCs, and the proposed
requirements and payment for a new G-code for virtual communication for
payment for communication technology-based and remote evaluation
services. The majority of the commenters were very supportive of both
proposals, and some requested clarification on issues related to
billing, cost reporting, and payment for care management and virtual
communication services in RHCs and FQHCs.
Comment: Several commenters requested clarification of how the
inclusion of the new chronic care management code, CPT code 99491
(previously referred to as CPT code 994X7), would impact the payment of
HCPCS code G0511 (the RHC and FQHC General Care Management code), and
requested assurance that adding this code to the codes used to
determine the payment for HCPCS code G0511 would not result in a lower
payment rate.
Response: In the CY 2018 PFS final rule, we stated that if a new
care management code is proposed and subsequently finalized for
practitioners billing under the PFS, we would review the new code to
determine if it should be included in the calculation of the RHC and
FQHC General Care Management Code. The determination of whether a new
care management code should be added to the codes used to determine the
payment rate is based on the applicability of the service in RHCs and
FQHCs, and may result in either an increase or decrease in the payment
amount for HCPCS code G0511.
CPT code 99491 is for 30 minutes or more of CCM furnished by a
physician or other qualified health care professional. Since this is
similar to CPT codes 99490 and 99487, we determined that it should be
included in the RHC and FQHC General Care Management code, which is
paid using HCPCS code G0511. The CY 2019 payment rate for this code is
expected to be $74.26, and the payment rate for CY 2019 payment rate
for HCPCS code G0511 is expected to be approximately $67, which will
result in a higher payment for HCPCS code G0511 than it would have been
if CPT code 99491 was not added to the codes used to determine the
rate. The rate is adjusted annually based on the PFS payment rates for
these codes.
Comment: A commenter stated that the care management services
included in the PFS are already contemplated and included in the RHC
AIR and the FQHC PPS payments, which are designed to cover all
activities related to a comprehensive primary care visit, even if they
do not occur on the same day. The commenter did not support separate
payment to RHCs and FQHCs for care management services, and stated that
paying separately for these services results in duplicative payment.
The commenter also noted that because the care management payment is
made through the RHC and FQHC payment systems, it does not trigger a
budget-neutrality adjustment and therefore represents additional
spending for the Medicare program and its beneficiaries.
Response: Comprehensive, high quality, and coordinated primary care
has always been an integral part of RHC and FQHC services in their
communities, We respectfully disagree with the suggestion that the type
of structured chronic care management and behavioral health integration
services that are now separately paid as care management are already
included in the RHC AIR or the FQHC PPS payment methodologies. These
services have specific requirements which have not typically or
routinely been provided by RHCs or FQHCs, and therefore have not been
factored into either the RHC AIR or the FQHC PPS rate. RHC and FQHC
payments are not subject to the budget neutrality provisions of the
PFS, and we believe that the cost-saving potential of these services is
likely to offset any additional Medicare spending.
Comment: A commenter encouraged CMS to evaluate the additional
costs of providing CCM services for people with limited English
proficiency and to adjust payment accordingly in future rulemaking.
Response: We are aware that some RHCs and FQHCs have a higher than
average rate of patients with limited English proficiency, which may
sometimes require additional time or resources. However, once the
minimum requirements for care management are met, the RHC or FQHC can
bill for the service, and the rate is based on the average cost of
furnishing the services.
Comment: Several commenters noted their support for a new G-code
for payment for communication technology[hyphen]based and remote
evaluation services and requested that CMS investigate its authority to
allow FQHCs to serve as distant site providers for telehealth services
to Medicare beneficiaries.
Response: Although both telehealth and virtual communication
services use technology to communicate, these are separate and distinct
services. Telehealth services are considered a substitute for an in-
person visit, and are therefore paid at the same rate as it would have
been had it been furnished in person. With some exceptions, telehealth
services require the use of interactive audio and digital
telecommunication systems that permit real-time communication between
the practitioner at the distant site and the beneficiary at the
originating site. The communication technology-based and remote
evaluation services that we proposed are not a substitute for a visit,
but are instead brief discussions with the RHC or FQHC practitioner to
determine if a visit is necessary. If the discussion between the RHC or
FQHC practitioner and the Medicare beneficiary results in a billable
visit, then the usual RHC or FQHC billing would occur. The virtual
communication G-code would only be separately payable if the discussion
between the RHC or FQHC practitioner does not result from or lead to an
RHC or FQHC billable visit. The payment rate for communication
technology-based services are valued based on the shorter duration of
time and the efficiencies associated with the use of communication
technology.
Section 1834(m)(4)(C)(ii) of the Act authorizes RHCs and FQHCs to
serve as telehealth ``originating sites'' (that is, where the patient
is located) for qualified telehealth services. Section 1834(m)(1) of
the Act, which describes distant site telehealth services (where the
practitioner is located), does not include RHCs and FQHCs. We do not
have the authority to allow RHCs and FQHCs to furnish distant site
telehealth services, and RHCs and FQHCs may not bill for distant site
telehealth services under the PFS.
Comment: Some commenters supported a separate payment for
communication technology-based and remote evaluation services using a
virtual communication G-code because these new services were not
included in the calculation of the Medicare FQHC PPS rate, but
requested that CMS reconsider the payment amount for these services.
The commenters suggested that because an FQHC practitioner is required
and the face-to-face requirements for these services are waived, the
payment should be on par with a traditional FQHC visit.
Response: We disagree with the suggestion that the payment be on
par with a regular FQHC visit. If the communication technology-based or
remote evaluation service results in a face-to-face visit with an RHC
or FQHC practitioner, the cost of the brief communication with the RHC
or FQHC practitioner would already be included in the RHC AIR or the
FQHC PPS payment. If the communication

[[Page 59686]]

technology-based or remote evaluation service does not originate from
or result in a face-to-face visit with an RHC or FQHC practitioner, the
RHC or FQHC may bill using the new virtual communication G-code. The
payment rate for these services under the PFS reflects the resource
costs of these non-face-to-face services relative to other PFS
services, including face-to-face and in-person visits. We did not
propose payment for these services as an RHC or FQHC visit or at the
same payment rate as an RHC or FQHC visit because these services do not
meet the requirements for an RHC or FQHC billable visit, and payment at
the RHC AIR or FQHC PPS would result in a payment rate incongruent with
efficiencies inherent in the provision of these communication services.
Comment: Commenters recommended not implementing any type of
frequency limitation, especially as RHCs and FQHCs learn to utilize
these services for their patients. Commenters stated that any frequency
limitation would be arbitrary, may have the opposite effect of the
provision's intended purpose to encourage innovative ways to provide
comprehensive care to Medicare beneficiaries, that the reimbursement
rate does not provide a financial incentive for overuse of this
service, and that the cost of virtual visits, even if unlimited, would
more than offset the cost of even one emergency room visit.
Response: We agree that frequency limitations should not be
implemented at this time.
Comment: Some commenters questioned the feasibility of billing for
virtual communication services because they noted that the coinsurance
requirement will discourage individuals from utilizing virtual
communication services to assess whether or not they need to come in
for an E/M visit, and will create patient confusion and dissatisfaction
if they receive a bill for these services.
Response: We are aware that coinsurance can be a barrier for some
beneficiaries, but we do not have the statutory authority to waive the
coinsurance requirement. RHCs and FQHCs should inform their patients
that coinsurance applies, and provide information on the availability
of assistance to qualified patients in meeting their cost sharing
obligations, or any other programs to provide financial assistance, if
applicable.
Comment: A few commenters expressed concern about how care
management is currently reported and how virtual communication services
will be reported on the RHC cost report. The commenters stated that
although care management services are considered RHC services, they are
reported separately on line 80 in the non-reimbursable section of the
cost report, and as a result, they are not considered allowable costs
on the RHC cost report. The commenters stated that this process is
administratively cumbersome, exposes the RHC to an audit risk, and
represents a significant barrier for RHCs in offering care management
services. The commenters suggested that the costs included on line 80
should only be the direct costs associated with care management
services, which would allow RHCs to more easily identify those costs
and assure them that they are completing this form correctly. The
commenters noted similar concerns for the reporting of virtual
communication services, and recommended that CMS allow the costs
associated with virtual communication to be reported in the
reimbursable section of the RHC cost report.
Response: Reducing administrative burden and encouraging the
appropriate use of services is a high priority for CMS, and we
appreciate the detailed comments and suggested changes regarding the
reporting of care management and virtual communication services on the
RHC cost report. Cost reporting information in typically provided in
subregulatory guidance, and we will carefully consider these comments.
Comment: A commenter questioned how virtual communication that
occurs during non-RHC hours would be billed and calculated on the cost
report.
Response: Services such as care management and virtual
communication services are not billable visits in RHCs and FQHCs and
may occur outside of the RHC's or FQHC's posted hours. As stated
previously, information on cost reporting will be provided in
subregulatory guidance.
Comment: Some commenters recommended removing the timeframe
restrictions for billing virtual communication services, stating that
they are vague, arbitrary, administratively burdensome, or that
allowing daily check in would improve health and reduce costs. Other
commenters suggested modifying the timeframe limitations with a clear
cut-off that RHCs and FQHCs can track and calculate, such as within the
previous 3 days or subsequent 24 hours, or the previous and subsequent
24 hours. One commenter stated that the timeframe restrictions would
require RHCs and FQHCs to review prior patient clinical activity,
assess the diagnostic category of any recent activity, and then delay
for 24 hours to ascertain whether the service is followed by a clinical
visit, rather than billing immediately for the services. This commenter
also stated that most computer billing systems are not set up for this
type of review, and a supplemental billing process would be costly, and
noted that there are no restrictions on face-to-face visits in RHCs or
FQHCs.
Response: PFS payments for HCPCS code G2012 (communication
technology-based services), and HCPCS code G2010 (remote evaluation
services) are based on the descriptor for CPT code 99441 (Telephone
evaluation and management service by a physician or other qualified
health care professional who may report evaluation and management
services provided to an established patient, parent, or guardian not
originating from a related E/M service provided within the previous 7
days nor leading to an E/M service or procedure within the next 24
hours or soonest available appointment; 5-10 minutes of medical
discussion). HCPCS code G0071, the new virtual communication G-code for
RHCs and FQHCs, is set at the average of the PFS national non-facility
payment rates for HCPCS codes G2012 and G2010, and would be billed by
the RHC or FQHC when the minimum requirements for either of these codes
are met.
Except for the Initial Preventive Physical Exam and the Annual
Wellness Visit, RHC and FQHC visits do not have frequency limitations,
and a patient could have more than one RHC or FQHC billable visit in
the same week if it is a medically-necessary, face-to-face visit with
an RHC or FQHC practitioner. If a service is not medically-necessary,
or is not furnished by an RHC or FQHC practitioner, or does not require
the skill level of an RHC or FQHC practitioner, it would not be a
billable visit. Since the RHC AIR and FQHC PPS payment methodologies
are designed to include all services and supplies incident to a visit,
the absence of time restrictions could result in duplicate payment to
the RHC or FQHC. Since the virtual communication payment is designed to
provide payment to the RHC or FQHC when there is no billable visit, the
time restrictions are necessary to avoid any duplicate payment.
Communication technology-based and remote evaluation services are
initiated by a patient who has been seen in the past year by the RHC or
FQHC practitioner, and in many cases, a review of prior patient
clinical activity and diagnoses would be necessary as part of the
virtual communication with the patient. Since most RHCs and FQHCs are
utilizing electronic health records, we expect that RHCs and

[[Page 59687]]

FQHCs will be able to comply with the time restrictions without any
additional burden. It is also our understanding that most RHCs and
FQHCs (like other providers and supplies) may not always submit a claim
immediately upon furnishing a service. As with any new service, we
expect that there would be a period of adjustment, and we will monitor
implementation to determine if changes are necessary.
Comment: Commenters questioned if an RHC could bill for virtual
communication services if the discussion results in the patient going
to an emergency room, an urgent care center, or a specialist not
affiliated with the RHC or FQHC, or if it leads to an ``incident-to''
service at the RHC (such as an injection) that is not a billable visit.
Response: If the discussion with the RHC or FQHC practitioner does
not occur within 7 days of an RHC or FQHC visit, and does not result in
an RHC or FQHC visit with 24 hours or the soonest available appointment
with an RHC or FQHC practitioner, and all other requirements are met,
the RHC or FQHC could bill for virtual communication services. This
would apply even if the patient is subsequently seen in an emergency
room, urgent care center, or by a non-RHC or FQHC practitioner, or has
a subsequent non-billable service in the RHC or FQHC such as an
injection.
Comment: A commenter questioned if communication technology-based
and remote evaluation services could be used by RHC and FQHC
practitioners to help beneficiaries determine whether they should visit
an RHC or FQHC for DSMT services, and states that this would allow RHC
and FQHC practitioners to reach beneficiaries in both rural and urban
underserved area and improve the lives of beneficiaries with diabetes.
Another commenter questioned if the new virtual communication codes for
RHCs and FQHCs would impact payment for DSMT in FQHCs.
Response: We agree that outreach and education to communities on
diabetes prevention services are important, especially in rural and
urban underserved areas. However, communication technology-based and
remote evaluation services would be billable by RHCs and FQHCs only
when the discussion requires the skill level of the RHC or FQHC
practitioner. If the discussion could be conducted by a nurse, health
educator, or other clinical personnel, it would not be billable as a
virtual communication service. Payment for DSMT in FQHCs would not be
impacted by the new virtual communication codes.
Comment: A commenter agreed that virtual communication services
should be limited to established patients (seen by an RHC or FQHC
practitioner within the previous year), and recommends that audio-only
technology (that is, telephone) should be allowed for virtual check-ins
because many RHC or FQHC patients may not have access to technology
capabilities beyond audio-only communication.
Response: We note that while other technology can be used,
telephone discussions are acceptable for billing the virtual
communication G-code.
Comment: A commenter suggested that CMS should consider redefining
what constitutes a billable RHC visit and develop a new and expansive
definition so that new healthcare services such as care management and
virtual communication services can be incorporated in the RHC cost-
based model in the same manner as face-to-face billable visits.
Response: We welcome suggestions on modifying program requirements,
but redefining RHC and FQHC billable visits is outside the scope of
this regulation.
Comment: A commenter stated that the proposed PFS change for CPT
code 99213 will result in independent RHCs and provider-based RHCs with
more than 50 beds being paid $10 less per visit than practitioners
billing under the PFS. The commenter stated that this will cause some
RHCs to leave the RHC program, resulting in higher costs to Medicare,
and questioned what can be done to raise the RHC capped encounter
payment.
Response: RHCs are paid based on their costs, subject to a payment
limit set out at section 1833(f) of the Act, except for those RHCs that
have an exception to the payment limit, and is adjusted annually based
on the Medicare Economic Index. We do not have the authority to make
changes in the RHC payment rate.
Comment: A commenter questioned if this proposed change will impact
the FQHC payment rate.
Response: The RHC AIR and the FQHC PPS would not be impacted by
these changes.
Comment: A commenter questioned if the new virtual communication G-
code would be accepted by Medicare Advantage Plans.
Response: HCPCS code G0071 is part of the HCPCS code set and must
be accepted by all payers as a HIPAA standard (45 CFR 162.1002). RHCs
and FQHCs should consult their associated MA plans for billing
information.
Comment: A commenter questioned whether the two new add-on codes
proposed for inherent visit complexity would apply to RHCs and FQHCs
and be eligible for separate payment in addition to their standard all
inclusive rate, and several commenters requested that RHCs and FQHCs be
allowed to bill separately for interprofessional internet
consultations.
Response: The two new add-on codes proposed for inherent visit
complexity are for practitioners billing under the PFS, and do not
apply to RHCs and FQHCs. The RHC AIR and the FQHC PPS includes all
costs associated with a billable visit, and therefore consultations
with other practitioners are not separately billable.
Comment: We received comments on allowing RNs to provide billable
visits in RHCs, allowing FQHCs to bill for assessment and care planning
for patients with cognitive impairment, reducing the requirements for
psychiatric collaborative care management services in RHCs and FQHCs,
providing separate payment to RHCs and FQHCs for medications to treat
alcohol and substance use disorders, revising payment for pneumococcal
vaccines, and reducing the requirements for patient consent for care
management services.
Response: These comments are beyond the scope of this rule.
5. Finalized Provisions
As a result of the comments, we are finalizing the following
provisions:
Effective January 1, 2019, the payment rate for HCPCS code
G0511 (General Care Management Services) is set at the average of the
national non-facility PFS payment rates for CPT codes 99490, 99487,
99484, and 99491.
Effective January 1, 2019, RHCs and FQHCs are paid for
HCPCS code G0071 (Virtual Communication Services), when HCPCS code
G0071 is on an RHC or FQHC claim, either alone or with other payable
services, and at least 5 minutes of communication technology-based or
remote evaluation services are furnished by an RHC or FQHC practitioner
to a patient who has had an RHC or FQHC billable visit within the
previous year, and the medical discussion or remote evaluation is for a
condition not related to an RHC or FQHC service provided within the
previous 7 days, and does not lead to an RHC or FQHC visit within the
next 24 hours or at the soonest available appointment. We are adding a
new paragraph (e) to Sec. 405.2464 to reflect this payment and making
additional minor conforming changes to this section.
HCPCS code G0071 is set at the average of the national
non-facility PFS payment rates for HCPCS code G2012

[[Page 59688]]

(communication technology-based services) and HCPCS code G2010 (remote
evaluation services) and is updated annually based on the PFS national
non-facility payment rate for these codes.
RHC and FQHC face-to-face requirements are waived when
these services are furnished to an RHC or FQHC patient. Coinsurance and
deductibles apply to RHC claims for G0071 and coinsurance applies to
FQHC claims for G0071.
6. Other Regulatory Updates
In addition to the regulatory change described in this section of
the rule, we are finalizing the following technical corrections for
accuracy:
Removal of the extra section mark in the definition of
``Federally qualified health center (FQHC)'' in Sec. 405.2401.
Replacing the word ``his'' with ``his or her'' in the
definition of ``Secretary'' in Sec. 405.2401.
Reordering the occurrence of RHC and FQHC in Sec.
405.2462(g).
7. Substance Use-Disorder Prevention That Promotes Opioid Recovery and
Treatment (SUPPORT) for Patients and Communities Act
Section 6083 of the SUPPORT for Patients and Communities Act (Pub.
L. 115-271, enacted on October 24, 2018) provides additional payments
to RHCs and FQHCs for services furnished for the treatment of opioid
use disorders by practitioners meeting certain requirements. We
anticipate guidance from the Department of Health and Human Services on
the implementation of this provision will be forthcoming.

D. Appropriate Use Criteria for Advanced Diagnostic Imaging Services

Section 218(b) of the Protecting Access to Medicare Act (PAMA)
(Pub. L. 113-93, enacted April 1, 2014) amended Title XVIII of the Act
to add section 1834(q) of the Act directing us to establish a program
to promote the use of appropriate use criteria (AUC) for advanced
diagnostic imaging services. The CY 2016 PFS final rule with comment
period addressed the initial component of the new Medicare AUC program,
specifying applicable AUC. In that rule (80 FR 70886), we established
an evidence-based process and transparency requirements for the
development of AUC, defined provider-led entities (PLEs) and
established the process by which PLEs may become qualified to develop,
modify or endorse AUC. The first list of qualified PLEs was posted on
the CMS website at the end of June 2016 at which time their AUC
libraries became specified applicable AUC for purposes of section
1834(q)(2)(A) of the Act. The CY 2017 PFS final rule addressed the
second component of this program, specification of qualified clinical
decision support mechanisms (CDSMs). In the CY 2017 PFS final rule (81
FR 80170), we defined CDSM, identified the requirements CDSMs must meet
for qualification, including preliminary qualification for mechanisms
documenting how and when each requirement is reasonably expected to be
met, and established a process by which CDSMs may become qualified. We
also defined applicable payment systems under this program, specified
the first list of priority clinical areas, and identified exceptions to
the requirement that ordering professionals consult specified
applicable AUC when ordering applicable imaging services. The first
list of qualified CDSMs was posted on the CMS website in July 2017.
The CY 2018 PFS final rule addressed the third component of this
program, the consultation and reporting requirements. In the CY 2018
PFS final rule (82 FR 53190), we established the start date of January
1, 2020 for the Medicare AUC program for advanced diagnostic imaging
services. It is for services ordered on and after this date that
ordering professionals must consult specified applicable AUC using a
qualified CDSM when ordering applicable imaging services, and
furnishing professionals must report AUC consultation information on
the Medicare claim. We further specified that the AUC program will
begin on January 1, 2020 with a year-long educational and operations
testing period during which time AUC consultation information is
expected to be reported on claims, but claims will not be denied for
failure to include proper AUC consultation information. We also
established a voluntary period from July 2018 through the end of 2019
during which ordering professionals who are ready to participate in the
AUC program may consult specified applicable AUC through qualified
CDSMs and communicate the results to furnishing professionals, and
furnishing professionals who are ready to do so may report AUC
consultation information on the claim (https://www.cms.gov/Outreach-
and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/
Downloads/MM10481.pdf). Additionally, to incentivize early use of
qualified CDSMs to consult AUC, we established in the CY 2018 Updates
to the Quality Payment Program; and Quality Payment Program: Extreme
and Uncontrollable Circumstances Policy for the Transition Year final
rule with comment period and interim final rule (hereinafter ``CY 2018
Quality Payment Program final rule'') a high-weight improvement
activity for ordering professionals who consult specified AUC using a
qualified CDSM for the Merit-based Incentive Payment System (MIPS)
performance period that began January 1, 2018 (82 FR 54193).
In the CY 2019 PFS proposed rule, we proposed additions to the
definition of applicable setting, clarification around who may perform
the required AUC consultation using a qualified CDSM under this
program, clarification that reporting is required across claim types
and by both the furnishing professional and furnishing facility,
changes to the policy for significant hardship exceptions for ordering
professionals under this program, mechanisms for claims-based
reporting, and a solicitation of feedback regarding the methodology to
identify outlier ordering professionals.
1. Background
AUC present information in a manner that links: A specific clinical
condition or presentation; one or more services; and an assessment of
the appropriateness of the service(s). Evidence-based AUC for imaging
can assist clinicians in selecting the imaging study that is most
likely to improve health outcomes for patients based on their
individual clinical presentation. For purposes of this program, AUC is
a set or library of individual appropriate use criteria. Each
individual criterion is an evidence-based guideline for a particular
clinical scenario based on a patient's presenting symptoms or
condition.
AUC need to be integrated as seamlessly as possible into the
clinical workflow. CDSMs are the electronic portals through which
clinicians access the AUC during the patient workup. They can be
standalone applications that require direct entry of patient
information, but may be more effective when they are integrated into
electronic health records (EHRs). Ideally, practitioners would interact
directly with the CDSM through their primary user interface, thus
minimizing interruption to the clinical workflow.
2. Statutory Authority
Section 218(b) of the PAMA added a new section 1834(q) of the Act
entitled, ``Recognizing Appropriate Use Criteria for Certain Imaging
Services,'' which directs the Secretary to establish a new program to
promote the use of AUC. Section 1834(q)(4) of the Act requires

[[Page 59689]]

ordering professionals to consult with specified applicable AUC through
a qualified CDSM for applicable imaging services furnished in an
applicable setting and paid for under an applicable payment system; and
payment for such service may only be made if the claim for the service
includes information about the ordering professional's consultation of
specified applicable AUC through a qualified CDSM.
3. Discussion of Statutory Requirements
There are four major components of the AUC program under section
1834(q) of the Act, and each component has its own implementation date:
(1) Establishment of AUC by November 15, 2015 (section 1834(q)(2) of
the Act); (2) identification of mechanisms for consultation with AUC by
April 1, 2016 (section 1834(q)(3) of the Act); (3) AUC consultation by
ordering professionals, and reporting on AUC consultation by January 1,
2017 (section 1834(q)(4) of the Act); and (4) annual identification of
outlier ordering professionals for services furnished after January 1,
2017 (section 1834(q)(5) of the Act). We did not identify mechanisms
for consultation by April 1, 2016. Therefore, we did not require
ordering professionals to consult CDSMs or furnishing professionals to
report information on the consultation by the January 1, 2017 date.
a. Establishment of AUC
In the CY 2016 PFS final rule with comment period, we addressed the
first component of the Medicare AUC program under section 1834(q)(2) of
the Act--the requirements and process for establishment and
specification of applicable AUC, along with relevant aspects of the
definitions under section 1834(q)(1) of the Act. This included defining
the term ``provider-led entity'' and finalizing requirements for the
rigorous, evidence-based process by which a PLE would develop AUC, upon
which qualification is based, as provided in section 1834(q)(2)(B) of
the Act and in the CY 2016 PFS final rule with comment period. Using
this process, once a PLE is qualified by us, the AUC that are
developed, modified or endorsed by the qualified PLE are considered to
be specified applicable AUC under section 1834(q)(2)(A) of the Act. We
defined PLE to include national professional medical societies, health
systems, hospitals, clinical practices and collaborations of such
entities such as the High Value Healthcare Collaborative or the
National Comprehensive Cancer Network. Qualified PLEs may collaborate
with third parties that they believe add value to their development of
AUC, provided such collaboration is transparent. We expect qualified
PLEs to have sufficient infrastructure, resources, and the relevant
experience to develop and maintain AUC according to the rigorous,
transparent, and evidence-based processes detailed in the CY 2016 PFS
final rule with comment period.
In the same rule we established a timeline and process under Sec.
414.94(c)(2) for PLEs to apply to become qualified. Consistent with
this timeline the first list of qualified PLEs was published at https:/
/www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-
Instruments/Appropriate-Use-Criteria-Program/PLE.html in June 2016 (OMB
Control Number 0938-1288).
b. Mechanism for AUC Consultation
In the CY 2017 PFS final rule, we addressed the second major
component of the Medicare AUC program--the specification of qualified
CDSMs for use by ordering professionals for consultation with specified
applicable AUC under section 1834(q)(3) of the Act, along with relevant
aspects of the definitions under section 1834(q)(1) of the Act. This
included defining the term CDSM and finalizing functionality
requirements of mechanisms, upon which qualification is based, as
provided in section 1834(q)(3)(B) of the Act and in the CY 2017 PFS
final rule. CDSMs may receive full qualification or preliminary
qualification if most, but not all, of the requirements are met at the
time of application. The preliminary qualification period began June
30, 2017 and ends when the AUC consulting and reporting requirements
become effective on January 1, 2020. The preliminarily qualified CDSMs
must meet all requirements by that date. We defined CDSM as an
interactive, electronic tool for use by clinicians that communicates
AUC information to the user and assists them in making the most
appropriate treatment decision for a patient's specific clinical
condition. Tools may be modules within or available through certified
EHR technology (as defined in section 1848(o)(4) of the Act) or private
sector mechanisms independent from certified EHR technology or a
mechanism established by the Secretary.
In the CY 2017 PFS final rule, we established a timeline and
process in Sec. 414.94(g)(2) for CDSM developers to apply to have
their CDSMs qualified. Consistent with this timeline, the first list of
qualified CDSMs was published at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/CDSM.html in July 2017 (OMB Control Number 0938-1315).
c. AUC Consultation and Reporting
In the CY 2018 PFS final rule, we addressed the third major
component of the Medicare AUC program--consultation with applicable AUC
by the ordering professional and reporting of such consultations under
section 1834(q)(4) of the Act. We established a January 1, 2020
effective date for the AUC consultation and reporting requirements for
this program. We also established a voluntary period during which early
adopters can begin reporting limited consultation information on
Medicare claims from July 2018 through December 2019. During the
voluntary period there is no requirement for ordering professionals to
consult AUC or furnishing professionals to report information related
to the consultation. On January 1, 2020, the program will begin with an
educational and operations testing period and during this time we will
continue to pay claims whether or not they correctly include AUC
consultation information. Ordering professionals must consult specified
applicable AUC through qualified CDSMs for applicable imaging services
furnished in an applicable setting, paid for under an applicable
payment system and ordered on or after January 1, 2020; and furnishing
professionals must report the AUC consultation information on the
Medicare claim for these services ordered on or after January 1, 2020.
Consistent with section 1834(q)(4)(B) of the Act, we also
established that furnishing professionals must report the following
information on Medicare claims for advanced diagnostic imaging services
as specified in section 1834(q)(1)(C) of the Act and defined in Sec.
414.94(b), furnished in an applicable setting as defined in section
1834(q)(1)(D) of the Act, paid for under an applicable payment system
as defined in section 1834(q)(4)(D) of the Act, and ordered on or after
January 1, 2020: (1) The qualified CDSM consulted by the ordering
professional; (2) whether the service ordered would or would not adhere
to specified applicable AUC, or whether the specified applicable AUC
consulted was not applicable to the service ordered; and (3) the NPI of
the ordering professional (if different from the furnishing
professional). Clarifying revisions to the reporting requirement are
discussed later in this preamble.
Section 1834(q)(4)(C) of the Act provides for exceptions to the AUC
consultation and reporting requirements in the case of: A service
ordered for an

[[Page 59690]]

individual with an emergency medical condition, a service ordered for
an inpatient and for which payment is made under Medicare Part A, and a
service ordered by an ordering professional for whom the Secretary
determines that consultation with applicable AUC would result in a
significant hardship. In the CY 2017 PFS final rule, we adopted a
regulation at Sec. 414.94(h)(1)(i) to specify the circumstances under
which AUC consultation and reporting requirements are not applicable.
These include applicable imaging services ordered: (1) For an
individual with an emergency medical condition (as defined in section
1867(e)(1) of the Act); (2) for an inpatient and for which payment is
made under Medicare Part A; and (3) by an ordering professional who is
granted a significant hardship exception to the Medicare EHR Incentive
Program payment adjustment for that year under Sec. 495.102(d)(4),
except for those granted under Sec. 495.102(d)(4)(iv)(C). In the CY
2019 PFS proposed rule, we proposed changes to the conditions for
significant hardship exceptions, and we summarize and respond to public
comments on our proposals later in this preamble. We remind readers
that, consistent with section 1834(q)(4)(A) of the Act, ordering
professionals must consult AUC for every applicable imaging service
furnished in an applicable setting and paid under an applicable payment
system unless a statutory exception applies.
Section 1834(q)(4)(D) of the Act specifies the applicable payment
systems for which AUC consultation and reporting requirements apply
and, in the CY 2017 PFS final rule, consistent with the statute, we
defined applicable payment system in our regulation at Sec. 414.94(b)
as: (1) The PFS established under section 1848(b) of the Act; (2) the
prospective payment system for hospital outpatient department services
under section 1833(t) of the Act; and (3) the ambulatory surgical
center payment system under section 1833(i) of the Act.
Section 1834(q)(1)(D) of the Act specifies the applicable settings
in which AUC consultation and reporting requirements apply: A
physician's office, a hospital outpatient department (including an
emergency department), an ambulatory surgical center, and any other
``provider-led outpatient setting determined appropriate by the
Secretary.'' In the CY 2017 PFS final rule, we added this definition to
our regulation at Sec. 414.94(b). Proposed additional applicable
settings are discussed later in this preamble.
d. Identification of Outliers
The fourth component of the Medicare AUC program is specified in
section 1834(q)(5) of the Act, Identification of Outlier Ordering
Professionals. The identification of outlier ordering professionals
under this paragraph facilitates a prior authorization requirement that
applies for outlier professionals beginning January 1, 2020, as
specified under section 1834(q)(6) of the Act. Because we established a
start date of January 1, 2020 for AUC consultation and reporting
requirements, we will not have identified any outlier ordering
professionals by that date. As such, implementation of the prior
authorization component is delayed. However, we did finalize in the CY
2017 PFS final rule the first list of priority clinical areas to guide
identification of outlier ordering professionals as follows:
Coronary artery disease (suspected or diagnosed).
Suspected pulmonary embolism.
Headache (traumatic and non-traumatic).
Hip pain.
Low back pain.
Shoulder pain (to include suspected rotator cuff injury).
Cancer of the lung (primary or metastatic, suspected or
diagnosed).
Cervical or neck pain.
We did not include proposals to expand or modify the list of
priority clinical areas in this final rule.
4. Proposals for Continuing Implementation
In the CY 2019 PFS proposed rule, we proposed to amend Sec. 414.94
of our regulations, ``Appropriate Use Criteria for Certain Imaging
Services,'' to reflect the following policies.
a. Expanding Applicable Settings
Section 1834(q)(1)(D) of the Act specifies that the AUC
consultation and reporting requirements apply only in an applicable
setting, which means a physician's office, a hospital outpatient
department (including an emergency department), an ambulatory surgical
center, and any other provider-led outpatient setting determined
appropriate by the Secretary. In the CY 2017 PFS final rule, we
codified this definition in Sec. 414.94(b). We proposed to revise the
definition of applicable setting to add an independent diagnostic
testing facility (IDTF).
We believe the addition of IDTFs to the definition of applicable
setting will ensure that the AUC program is in place across outpatient
settings in which outpatient advanced diagnostic imaging services are
furnished. IDTFs furnish services for a large number of Medicare
beneficiaries; nearly $1 billion in claims for 2.4 million
beneficiaries in 2010 (OEI-05-09-00560). An IDTF is independent of a
hospital or physician's office and diagnostic tests furnished by an
IDTF are performed by licensed, certified non-physician personnel under
appropriate physician supervision (Sec. 410.33). Like other applicable
settings, IDTFs must meet the requirements specified in Sec. 410.33 of
our regulations to be enrolled to furnish and bill for advanced
diagnostic imaging and other IDTF services. Services that may be
provided by an IDTF include, but are not limited to, magnetic resonance
imaging (MRI), ultrasound, x-rays, and sleep studies. An IDTF may be a
fixed location, a mobile entity, or an individual non-physician
practitioner, and diagnostic procedures performed by an IDTF are paid
under the PFS. IDTF services must be furnished under the appropriate
level of physician supervision as specified in Sec. 410.33(b); and all
procedures furnished by the IDTF must be ordered in writing by the
patient's treating physician or non-physician practitioner. As such, we
believe the IDTF setting is a provider-led outpatient setting
appropriate for addition to the list of applicable settings under
section 1834(q)(1)(D), and we proposed to add IDTF to our definition of
applicable setting under Sec. 414.94(b) of the regulations.
We note that under the PFS, payment for many diagnostic tests
including the advanced diagnostic imaging services to which the AUC
program applies can be made either ``globally'' when the entire service
is furnished and billed by the same entity; or payment can be made
separately for the technical component (TC) of the service and the
professional component (PC) when those portions of the service are
furnished and billed by different entities. In general, the TC for an
advanced diagnostic imaging service is the portion of the test during
which the patient is present and the image is captured. The PC is the
portion of the test that involves a physician's interpretation and
report on the captured image. For example, when a CT scan is ordered by
a patient's treating physician, the entire test (TC and PC) could be
furnished by a radiologist in their office and billed as a ``global''
service. Alternatively, the TC could be furnished and billed by an
IDTF, and the PC could be furnished and billed by a radiologist in
private practice. By adding IDTFs as an

[[Page 59691]]

applicable setting, we believe we would appropriately and consistently
apply the AUC program across the range of outpatient settings where
applicable imaging services are furnished.
We proposed to revise the definition of applicable setting under
Sec. 414.94(b) to include an IDTF. We invited comments on this
proposal and on the possible inclusion of any other applicable setting.
We reminded commenters that application of the AUC program is not only
limited to applicable settings, but also to services for which payment
is made under applicable payment systems (the PFS, the OPPS, and the
ASC payment system).
The following is a summary of the comments we received on revising
the definition of applicable setting under Sec. 414.94(b) to include
an IDTF and on the possible inclusion of any other applicable setting.
Comment: The majority of commenters supported adding IDTF to the
definition of applicable setting. These commenters agreed that this
addition would apply the AUC program appropriately and consistently
across outpatient settings where applicable advanced diagnostic imaging
services are furnished and reported. In contrast, a few commenters were
concerned with expanding the definition of applicable setting until CMS
and other impacted stakeholders have a better understanding of the
program and 3 to 5 years of experience with it. These commenters
suggested that any expanded definition will add complexity and make
implementation even more difficult by the 2020 required start date as
the addition of another applicable setting would require broader
reporting of AUC consultation information. To this end, these
commenters requested modification to the proposal to allow some
flexibility on the timeline to add IDTFs as an applicable setting.
Finally, a few commenters requested that the definition of applicable
setting be further expanded to include any office-based service,
including for example, situations in which physicians have an MRI in
their own office.
Response: We appreciate these perspectives by the commenters. We
continue to believe that the IDTF setting is a provider-led outpatient
setting appropriate for addition to the list of applicable settings
under section 1834(q)(1)(D) of the Act, and are finalizing this
definition as proposed. We disagree that the definition will add
complexity as we seek consistency in applying our regulations across
outpatient settings in which outpatient advanced diagnostic imaging
services are furnished, and would be concerned with applying these
requirements in different settings along different timelines. Because
we did not propose adding other settings to this definition we will not
expand it further in this final rule, but will continue to monitor
claims for advanced diagnostic imaging services across the Medicare
program. We remind readers that the physician's office (including one
where advanced imaging equipment is located), hospital outpatient
department (including an emergency department), and an ambulatory
surgical center are already included in the definition of applicable
setting.
After considering the comments, we are finalizing the proposal
revising the definition of applicable setting under Sec. 414.94(b) to
include an IDTF.
b. Consultations by Ordering Professionals
Section 1834(q)(1)(E) of the Act defines the term ``ordering
professional'' as a physician (as defined in section 1861(r)) or a
practitioner described in section 1842(b)(18)(C) who orders an
applicable imaging service. The AUC consultation requirement applies to
these ordering professionals. We proposed that the consultation with
AUC through a qualified CDSM may be performed by auxiliary personnel
under the direction of the ordering professional and incident to the
ordering professional's services, when the consultation is not
performed personally by the ordering professional whose NPI will be
listed on the order for an advanced imaging service.
In response to the CY 2018 PFS proposed rule, we received several
public comments requesting clarification regarding who is required to
perform the consultation of AUC through a qualified CDSM. Commenters
not only sought clarification, but also provided recommendations for
requirements around this topic. Some commenters recommended that CMS
strictly interpret the statutory language and only allow the clinician
placing the order to perform the consultation and others recommended
that CMS allow others to perform the AUC consultation on behalf of the
clinician.
Section 1834(q)(4)(A)(i) of the Act requires an ordering
professional to consult with a qualified CDSM, and this was codified in
our regulations at Sec. 414.94(j). The statute does not explicitly
provide for consultations under the AUC program to be fulfilled by
other professionals, individuals or organizations on behalf of the
ordering professional; however, we continue to seek ways to minimize
the burden of this new Medicare program and understand that many
practices currently use clinical staff, working under the direction of
the ordering professional, to interact with the CDSM for AUC
consultation and subsequent ordering of advanced diagnostic imaging.
Therefore, we proposed to modify paragraph Sec. 414.94(j) to specify
that additional individuals may perform the required AUC consultation.
When the AUC consultation is not performed personally by the
ordering professional, we proposed the consultation may be performed by
auxiliary personnel incident to the ordering physician or non-physician
practitioner's professional service. We believed this approach was
appropriate under this program and still accomplishes the goal of
promoting the use of AUC. This proposed policy would allow the ordering
professional to exercise their discretion to delegate the performance
of this consultation. It is important to note that the ordering
professional is ultimately responsible for the consultation as their
NPI is reported by the furnishing professional on the claim for the
applicable imaging service; and that it is the ordering professional
who could be identified as an outlier ordering professional and become
subject to prior authorization based on their ordering pattern.
We proposed to revise the AUC consultation requirement specified at
Sec. 414.94(j) to specify that the AUC consultation may be performed
by auxiliary personnel under the direction of the ordering professional
and incident to the ordering professional's services.
The following is a summary of the comments we received on this
proposal. Overall commenters either agreed or disagreed with the
proposal to expand who can perform the consultation with a qualified
CDSM, and the commenters that agreed with the concept of the proposal
either requested clarification around the term auxiliary personnel or
recommended that we use more specific language to describe eligible
personnel.
Comment: Some commenters were completely against the concept of
this proposal and did not support allowing anyone beyond the ordering
professional to perform the AUC consultation stating that allowing
anyone other than the ordering professional to perform the consultation
would undermine the intent of the AUC program and increase
administrative burden. A few of those commenters suggested that
expanding the scope of individuals who can perform the consultation
would actually increase

[[Page 59692]]

burden and confusion for ordering professionals. Others opposed the
proposal on the basis that the educational goals of the program would
be undermined or auxiliary personnel would manipulate the information
to achieve adherent responses. These commenters wanted ordering
professionals to be directly exposed to AUC. Some of the commenters
that agreed with the proposal specifically stated that the intent of
the AUC program would not be diminished by expanding AUC consultation
beyond the ordering professional. However, the vast majority of
commenters agreed that expanding beyond the ordering professional
allows flexibility and the opportunity for the AUC consultation
requirement to be less burdensome on the ordering professional.
Response: We agree that the AUC program should be a learning
program for ordering professionals. However, to balance the burden put
upon ordering professionals and their offices to comply with this
program as well as focus on the educational component of this program,
we maintain that expanding AUC consultations to individuals beyond the
ordering professional is an important step. We envision that the
ordering professionals will, even when they do not personally perform
the AUC consultation, remain closely involved and will engage with the
individual to whom they delegate the task of performing the
consultation. For many ordering professionals, this delegation may save
time when they routinely order tests that are consistently considered
to adhere to AUC. In those cases, the back-and-forth between the
ordering professional and the individual who conducts the consultation
may be minimal. We anticipate that, when an AUC consultation is
performed by someone other than the ordering professional and the
result is that the imaging service does not adhere to the consulted
AUC, that information will be provided back to the ordering
professional to allow them to consider whether a different test (or no
test) should be ordered, or if the original order is still appropriate
for the patient. Additionally, ordering professionals may still choose
to personally perform the consultation. This may be ideal for ordering
professionals with CDSMs that allow for seamless interaction, such as
the case of a CDSM integrated within an EHR.
Regardless of who performs the AUC consultation, the ordering
professional is ultimately responsible for the order and may become
subject to prior authorization if they demonstrate a pattern of non-
adherent orders. Therefore, the ordering professional not only has a
vested interest in terms of providing the right test for their patient,
but also to monitor the frequency with which they order tests that do
not adhere to AUC.
Comment: While the majority of commenters agreed with expanding
who, beyond the ordering professional, can personally perform the
consultation with a qualified CDSM, they expressed either confusion
with the term ``auxiliary personnel'' or recommended additional
regulatory language to more specifically identify the scope of
individuals who could perform the AUC consultation. Other commenters
questioned the applicability of ``incident to'' provisions since
consulting AUC through a CDSM is not a billable service.
Some commenters suggested additional language that would identify
specific licensed professionals, lay out training requirements, allow
for medical assistants or credentialed clinical staff, cite state scope
of practice laws, or require that the individual be present in the
office of the ordering professional. These commenters stated that the
AUC consultation should not be an administrative task that can be
performed by any staff member, such as a receptionist or data entry
clerk. The underlying concern of commenters that wanted to explicitly
allow only clinical personnel to consult AUC was that the individual
performing an AUC consultation would need to understand the patient's
medical information, the advanced imaging service being recommended and
the clinical information that is returned by the CDSM. Commenters
stated that this understanding on the part of the individual who
performs the AUC consultation was particularly important when a CDSM
indicates that the order is not adherent to AUC.
Some commenters specifically addressed our proposal that the
individual who consults AUC must be under the direction of the ordering
professional. At least one commenter noted the need for direct
supervision while another said the individual should be physically
located in the office of the ordering professional as opposed to off-
site. Other commenters suggested that we use language that allows for
maximum flexibility.
One commenter gave an example that drew parallels between CDSMs and
Computerized Provider Order Entry (CPOE) systems, and suggested the
same requirements should apply to individuals consulting CDSMs. The
commenter stated that for CPOE entries to count toward meeting Medicaid
Meaningful Use thresholds, the entry must be made by a licensed
healthcare professional or credentialed medical assistant. Similarly,
the commenter suggested the consultation should be performed consistent
with state scope of practice laws since the use of CPOE is limited to
those individuals referenced above, as it is within their state scope
of practice to enter orders into medical records.
Response: We agree with comments suggesting that the language we
proposed could potentially cause confusion, and we understand the
disagreement among commenters regarding precisely who, beyond the
ordering professional, should be eligible to perform the AUC
consultation. We further agree that the concept of services incident to
a physician's professional services may not be directly relevant to the
action of consulting AUC using a CDSM. We proposed using ``incident
to'' as a description of the relationship between the ordering
professional and the auxiliary personnel consulting the AUC.
We also agree that there are similarities between CPOE systems and
CDSMs, and that individuals using these systems should have some level
of knowledge of the clinical information they are inputting and,
importantly, the information they receive back from the system.
However, we also agree with the view of most commenters that ordering
professionals should have flexibility to delegate the AUC consultation
task. We also agree that the learning and educational aspects of AUC
are more likely to be realized when there is real communication between
the ordering professional and the person performing the consultation.
While we proposed the consultation could be performed incident to the
ordering professional's service, we agree with commenters that the
``incident to'' concept is difficult to apply to a service that is not
billable and does not require the patient to be present. We further
agree with comments recommending that there be good communication and a
close relationship between the ordering professional and individual
consulting the AUC. In the case of consulting AUC, we believe it is
important that the individual who uses the CDSM is working under the
ordering professional, and that the individual is available to the
ordering professional to discuss the results of the consultation and
any responsive adjustments to planned orders.
Comment: A few commenters suggested allowing the furnishing
professional to occasionally consult AUC using a CDSM. Another

[[Page 59693]]

commenter questioned whether auxiliary personnel would be permitted to
change the order based on the AUC consultation and an additional
commenter questioned whether physical therapists could write orders.
Response: While a furnishing professional may consult AUC as they
wish for other purposes, such a consultation would not suffice for
purposes of the AUC consultation required under this program. The AUC
consultation must be performed by the ordering professional or an
individual to whom the ordering professional has delegated it; and the
ordering professional may only delegate the required AUC consultation
to an individual as specified in our final policy. The furnishing
professional may perform their own AUC consultation to verify
information; however, that would not replace the consultation that is
required to be performed by the ordering professional or their
appropriately designated surrogate. The AUC program does not change the
scope of professionals permitted under law to write or change orders
for advanced diagnostic imaging services.
Comment: Some commenters questioned whether there was statutory
authority to allow anyone other than the ordering professional to
personally perform the AUC consultation with a CDSM.
Response: We do not believe it is inconsistent with the statute to
allow an individual other than the ordering professional to perform the
AUC consultation with a qualified CDSM. Moreover, regardless of who
performs the act of consulting with a qualified CDSM, it is important
to understand that the ordering professional remains ultimately
responsible for the AUC consultation and communication of the
consultation information to the furnishing professional.
Comment: A commenter who disagreed with our proposal to permit
certain individuals other than the ordering professional to perform the
AUC consultation suggested that the proposal is counter to the intent
of the existing regulation at Sec. 414.94(k) finalized in the CY 2018
PFS final rule. The commenter suggested that educating ordering
professionals regarding the optimal use of advanced imaging services
can only be accomplished when ordering professionals are directly
exposed to AUC.
Response: We believe the intent of the statutory provisions
requiring the AUC program is to increase appropriate ordering of
advanced imaging services through a learning system, and that can still
be achieved even if we allow delegation of the consultation when the
individual performing it has the proper training and is working under
the appropriate direction of the ordering professional.
Comment: One commenter requested a specific set of standards or
training requirements for such auxiliary personnel to ensure that
diagnostic imaging services comply with AUC requirements.
Response: At this time, we are not in a position to establish
training requirements or standards tailored to the AUC program for
individuals that may be delegated the AUC consultation.
Based on the public comments received, we do not believe it would
be appropriate to move forward with the proposal to specify the scope
of individuals who can perform the AUC consultation as auxiliary
personnel. We are modifying our proposal in response to comments, and
conforming the regulation at Sec. 414.94(j)(2), to clarify that, in
the event of a significant hardship, the requirement to consult AUC
does not apply and specify that, when not personally performed by the
ordering professional, the consultation with a qualified CDSM may be
performed by clinical staff under the direction of the ordering
professional. We have used the term clinical staff elsewhere in the
Medicare program to identify the individuals that may perform care
management services including chronic care management (CCM), behavioral
health integration (BHI) and transitional care management (TCM)
services. These services involve some non-face-to-face services along
with clinical activities around the care plan and communication and
coordination with the patient's other healthcare professionals. For
care management, the clinical staff requirement ensures that the
individual performing the service must have the level of clinical
knowledge necessary to effectively coordinate and communicate with the
treating clinician. Similarly, in the case of the AUC program, the
individual performing the AUC consultation must have sufficient
clinical knowledge to interact with the CDSM and communicate with the
ordering professional. After considering public comments on our
proposal, we have concluded that allowing clinical staff to perform the
AUC consultation under the direction of the ordering professional is a
better fit with the AUC program than our proposal, and is responsive to
public comments asserting that the concept of ``incident to'' is not
relevant in the context of the AUC program. We believe the policy we
are finalizing, to allow the AUC consultation to be performed by
clinical staff under the direction of the ordering professional,
further reflects a balance between those commenters who wanted only the
ordering professional to perform the consultation and those who
suggested we should allow the consultation to be delegated. Clinical
staff will have a level of knowledge that allows for effective
communication of advanced diagnostic imaging orders, interaction with
AUC, and engagement with the ordering professional, while they remain
under the direction of the ordering professional.
c. Reporting AUC Consultation Information
Section 1834(q)(4)(B) of the Act requires that payment for an
applicable imaging service furnished in an applicable setting and paid
for under an applicable payment system may only be made if the claim
for the service includes certain information about the AUC
consultation. As such, the statute requires that AUC consultation
information be included on any claim for an outpatient advanced
diagnostic imaging service, including those billed and paid under any
applicable payment system (the PFS, OPPS or ASC payment system). When
we initially codified the AUC consultation reporting requirement in
Sec. 414.94(k) through rulemaking in the CY 2018 PFS final rule, we
specified only that ``furnishing professionals'' must report AUC
consultation information on claims for applicable imaging services.
This led some stakeholders to believe that AUC consultation information
would be required only on practitioner claims. To better reflect the
statutory requirements of section 1834(q)(4)(B) of the Act, we proposed
to revise our regulations to clarify that AUC consultation information
must be reported on all claims for an applicable imaging service
furnished in an applicable setting and paid for under an applicable
payment system. The revised regulation would more clearly express the
scope of advanced diagnostic imaging services that are subject to the
AUC program, that is, those furnished in an applicable setting and paid
under an applicable payment system.
The language codified in Sec. 414.94(k) uses the term furnishing
professional to describe who must report the information on the
Medicare claims. We recognize that section 1834(q)(1)(F) of the Act
specifies that a ``furnishing professional'' is a physician (as defined
in section 1861(r)) or a practitioner described in section
1842(b)(18)(C) who furnishes an applicable imaging service.

[[Page 59694]]

However, because section 1834(q)(4)(B) of the Act, as described above,
clearly includes all claims paid under applicable payment systems
without exclusion, we believe that the claims from both furnishing
professionals and facilities must include AUC consultation information.
In other words, we would expect this information to be included on the
practitioner's claim for the PC of the applicable advanced diagnostic
imaging service and on the provider's or supplier's claim for the
facility portion or TC of the imaging service.
As such, we proposed to revise Sec. 414.94(k) to clearly reflect
the scope of claims for which AUC consultation information must be
reported, and to clarify that the requirement to report AUC
consultation information is not limited to the furnishing professional.
The following is a summary of the comments we received.
Comment: Some commenters stated that they appreciate the
clarification that the requirement to report AUC consultation
information is not limited to the furnishing professional. These
commenters thanked CMS for addressing the increasingly common instances
in which the TC and PC of an advanced diagnostic imaging service are
performed at separate locations. Additionally, these commenters
acknowledged that the clarification recognizes situations when payment
can be made globally, to include both the TC and PC furnished and
billed by the same entity, and situations of Method II billing by
critical access hospitals. In contrast, other commenters opposed the
reporting of AUC consultation information on all claims, specifically
the facility claims, for an applicable imaging service furnished in an
applicable setting and paid under an applicable payment system. These
commenters noted that requiring the reporting of AUC consultation
information does not appropriately target the ordering professionals
for whom the AUC program is intended, and creates a duplicative effort
when CMS receives AUC consultation information from both facilities and
furnishing professionals for different parts of the same exam. A few
other commenters expressed concern that requiring two sources of AUC
consultation information that relates to the same test for the same
patient could result in situations where one source was inaccurate or
provides conflicting information.
Response: The statutory requirement under section 1834(q)(4)(B) of
the Act specifies that payment for an applicable imaging service
furnished in an applicable setting and paid for under an applicable
payment system may only be made if the claim for the service includes
certain information about the AUC consultation. We recognize that this
requirement to report AUC consultation information is not placed on the
ordering professional, but rather on those submitting claims for the
advanced diagnostic imaging service that the ordering professional
orders. We also recognize that the TC or facility portion of an
applicable imaging service is frequently furnished and billed by a
different entity than the PC portion of the service. We do not
currently do any matching or comparison of separate claims for the PC
and TC or facility portion of an advanced diagnostic imaging service.
Rather, we process these separate claims individually, and have no
immediate plans to begin doing otherwise for purposes of the AUC
program. We hope to learn more about the implementation of this
program, including issues such as these commenters have raised, during
the educational and operations testing period.
After considering the comments, we are finalizing without
modification the proposal to revise Sec. 414.94(k) to clearly reflect
the scope of claims for which AUC consultation information must be
reported, and to make this requirement consistent with section
1834(q)(4)(B) of the Act.
d. Claims-Based Reporting
In the CY 2018 PFS proposed rule (82 FR 34094) we discussed using a
combination of G-codes and modifiers to report the AUC consultation
information on the Medicare claim. We received numerous public comments
objecting to this potential solution. In the 2018 PFS final rule, we
agreed with many of the commenters that additional approaches to
reporting AUC consultation information on Medicare claims should be
considered, and we learned from many commenters that reporting a unique
consultation identifier (UCI) would be a less burdensome and preferred
approach. The UCI would include all the information required under
section 1834(q)(4)(B) of the Act including an indication of AUC
adherence, non-adherence and not applicable responses. Commenters noted
that capturing a truly distinguishing UCI on the claim will allow for
direct mapping from a single AUC consultation to embedded information
within a CDSM. We indicated that we would work with stakeholders to
further explore the concept of using a UCI to satisfy the requirements
of section 1834(q)(4)(B) of the Act, which will be used for Medicare
claims processing and, ultimately, for the identification of outlier
ordering professionals, and consider developing a taxonomy for a UCI.
We had the opportunity to engage with some stakeholders over the
last 6 months and we understand that some commenters from the previous
rule continue to be in favor of a UCI, while some may have changed
their position upon further consideration.
We provide the following information to summarize alternatives we
considered. We had originally considered assigning a G-code for every
qualified CDSM with a code descriptor containing the name of the
qualified CDSM. The challenge to this approach arises when there is
more than one advanced imaging service on a single claim. We could
attribute a single G-code to all of the applicable imaging services for
the patient's clinical condition on the claim, which might be
appropriate if each AUC consultation for each service was through the
same CDSM. If a different CDSM was used for each service (for example,
when services on a single claim were ordered by more than one ordering
professional and each ordering professional used a different CDSM) then
multiple G-codes could be needed on the claim. Each G-code would appear
on the claim individually as its own line item. As a potential
solution, we considered the use of modifiers, which are appealing
because they would appear on the same line as the CPT code that
identifies the specific billed service. Therefore, information entered
onto a claim would arrive into the claims processing system paired with
the relevant AUC consultation information.
When reporting the required AUC consultation information based on
the response from a CDSM: (1) The imaging service would adhere to the
applicable AUC; (2) the imaging service would not adhere to such
criteria; or (3) such criteria were not applicable to the imaging
service ordered, three modifiers could be developed. These modifiers,
when placed on the same line with the CPT code for the advanced imaging
service would allow this information to be easily accessed in the
Medicare claims data and matched with the imaging service.
Stakeholders have made various suggestions for a taxonomy that
could be used to develop a UCI to report the required information.
Stakeholders have also considered where to place the UCI on the claim.
We understand the majority of solutions suggested by stakeholders
involving a UCI are claim-

[[Page 59695]]

level solutions and would not allow us to attribute the CDSM used or
the AUC adherence status (adherent or not adherent, or not applicable)
to a specific imaging service. As such, the approach of using a UCI
would not identify whether an AUC consultation was performed for each
applicable imaging service reported on a claim form, or be useful for
purposes of identifying outlier ordering professionals in accordance
with section 1834(q)(5) of the Act.
We have received ideas from stakeholders that are both for and
against the two approaches we have identified; and we appreciate the
stakeholders that have provided additional information or engaged us in
this discussion. Internally, we have explored the possibility of using,
and feasibility of developing, a UCI; and concluded that, although we
initiated this approach during the CY 2018 PFS final rule, it is not
feasible to create a uniform UCI taxonomy, determine a location of the
UCI on the claims forms, obtain the support and permission by national
bodies to use claim fields for this purpose, and solve the underlying
issue that the UCI seems limited to claim-level reporting. Using coding
structures that are already in place (such as G-codes and modifiers)
would allow us to establish reporting requirements prior to the start
of the program (January 1, 2020).
Since we did not finalize a proposal in the CY 2018 PFS final rule,
we proposed in this rule to use established coding methods, to include
G-codes and modifiers, to report the required AUC information on
Medicare claims. This would allow the program to be implemented by
January 1, 2020. We will consider future opportunities to use a UCI and
look forward to continued engagement with and feedback from
stakeholders.
The following is a summary of comments we received on this
proposal.
Comment: The majority of commenters agreed with our proposed
approach of using G-codes and modifiers to append AUC information on
claims. Of those commenters, most stated that the approach is not
without flaws, including increased workflow challenges and complexity,
time needed for staff to learn and incorporate these changes into
billing practices, and the limited information modifiers may convey for
outlier identification purposes. We summarize and respond to comments
on these issues below. However, they acknowledged that there is a lack
of better alternatives. Other commenters disagreed with the proposal,
and recommended CMS not require claims-based reporting until a UCI can
be reported on claims. In addition to those recommending a delay in
reporting, others suggested that CMS not require claims-based reporting
at all and instead allow information to be transmitted directly from
qualified CDSMs to CMS.
Response: We agree with commenters that G-codes and modifiers may
not be the ideal solution. However, it is important that we make
strides to implement this program and prepare stakeholders for the
method of reporting in the immediate years of the program. We will
continue to discuss with stakeholders the potential of using a UCI in
the future. There are hurdles to overcome with respect to the use of a
UCI that are discussed in the comment summaries and responses below.
Some of these include understanding how UCI information would be used
in the development of the eventual outlier ordering professional
methodology, and where it would be appended to the claim. In addition,
there is disagreement among stakeholders regarding whether the UCI
would contain a taxonomy and embed meaningful information.
Additionally, as we have consulted with stakeholders responsible for
updating the claims forms, which would be necessary to establish a
field to report a UCI on claims, we understand that it would be a
matter of years before the forms could be updated. As such, the
prospect of developing and using a UCI is not a realistic immediate
solution.
Comment: There were disagreements and concerns among commenters
that support the use of G-codes to identify which qualified CDSM was
consulted. Some were concerned that CMS could not develop G-codes
quickly enough to keep pace with newly qualified CDSMs and that the
total number of G-codes would be unwieldy. Others supported the use of
a single generic G-code to describe that a qualified CDSM was consulted
but would not identify a particular CDSM. Another commenter pointed out
that a G-code would not be necessary on claims when a CDSM was not
consulted, rather, only a modifier (placed on the same line as the CPT
code for the imaging service) would be used in these circumstances.
Commenters pointed out that claims for both the furnishing facility
and furnishing professional are capable of reporting G-codes and
modifiers, but identified an issue related to resorting of information
on claims as they are processed through the system. In other words, the
codes billed on separate claim lines can come through the system and
end up in a different order than how they originally appeared when the
claim was submitted. This means CMS cannot presume to pair an imaging
service reported on a specific claim line with a specific G-code when
more than one imaging service appears on the claim. A commenter
suggested that furnishing professionals could split their claims so
only one imaging service and one G-code would appear on each claim.
Commenters pointed out that while this is possible on the furnishing
professional claim, it is not possible on the furnishing facility claim
due to other rules involving facility billing and same-day procedures.
Response: We are optimistic that we can issue G-codes in a timely
manner upon qualifying new CDSMs. There are a number of CDSMs already
qualified and G-codes could be issued for those prior to the start of
the educational and operations testing period set to begin in 2020. We
could secure additional G-codes with general descriptors to describe
``newly qualified CDSM A,'' ``newly qualified CDSM B,'' etc. to be
ready for assignment to a specific CDSM upon qualification. That would
allow some time for the descriptor to be changed to reflect the name of
the CDSM, but also enable immediate use of the appropriate G-code for
reporting purposes. This information will be contained in standard
coding information issued by the agency as well as on the AUC website
that lists all qualified CDSMs.
Regarding the use of one generic G-code to describe that a
qualified CDSM was consulted, we are not confident that this would
satisfy the statutory requirement under section 1834(q)(4)(B) of the
Act to report which qualified CDSM was consulted. However, we may find
that generic codes are needed as a temporary measure as we move forward
with implementation.
If a CDSM is not consulted, for example due to the ordering
professional attesting to a significant hardship, then we agree that a
distinct G-code for that purpose is not necessary. Rather the modifier
describing that hardship could be placed on the same claim line as the
CPT code for the imaging service.
We agree with commenters that the issue of claims processing system
resorting of claims information is problematic. When multiple imaging
services are reported on a single claim, it will not be possible to
pair the G-code describing which CDSM was consulted with the imaging
service for which it was consulted. While we could require the
furnishing professional to split the claim, we are not committing to
that solution at this point but will explore that option as we move
forward with implementation. Another possible

[[Page 59696]]

solution, though still imperfect, could be to list the G-code on a line
and place the modifiers describing AUC adherence on the line with the
CPT code describing the imaging service. This model could work when the
same ordering professional has ordered all of the furnished imaging
services on the claim, and if we presume that an ordering professional
will consistently use only one qualified CDSM. We appreciate commenters
raising these issues and we will continue to explore options to address
them.
Comment: One commenter suggested that, instead of G-codes, CPT
codes should be developed to identify the qualified CDSM consulted.
Response: Initially we do not believe it will be possible for AMA-
CPT to issue CPT codes identifying qualified CDSMs in time for the
program to begin. We do, however, understand that there may be benefits
to making these codes Level 1 HCPCS codes that are issued by AMA-CPT as
opposed to HCPCS Level 3 codes (G-codes). We will look into the
benefits and potential problems of using CPT codes to describe which
qualified CDSM was consulted. An initial concern we have, in addition
to timing to accommodate the start of the AUC program, is whether CPT
code descriptors could be changed quickly enough to accommodate newly
qualified CDSMs and whether CPT codes would be set aside for future
use.
Comment: Many commenters observed that, under this AUC program,
qualified CDSMs must generate and provide a certification or
documentation at the time of order that documents which qualified CDSM
was consulted, the name and NPI of the ordering professional that
consulted the CDSM, and whether the service ordered would or would not
adhere to specified applicable AUC or whether the specified applicable
AUC consulted was not applicable to the service ordered. As a result,
these commenters assumed that the CDSM would also communicate the
relevant G-codes and modifiers, and requested that CMS clarify that
qualified CDSMs are required to explicitly communicate their assigned
G-code and the adherence modifier to the ordering professional. The
commenters stated that absent this clarification, some CDSMs may simply
convey their name and an indication (other than the relevant modifier)
as to whether the ordered service ``adhered,'' or ``didn't adhere,'' or
the AUC ``didn't apply'' to the imaging test. The commenters were
concerned that if CDSMs provide AUC consultation results in this way,
it would create additional burden for ordering professionals to
manually assign coding information to be transmitted for billing
purposes.
A few of these commenters stated that they requested this
clarification because they noted: (1) Each qualified CDSM will know its
G-code and can readily convert their adherence rating system into
modifiers, (2) the required data could be transmitted between EHR and
CDSM vendors and communicated between professionals in a standardized
manner, and (3) accuracy of consultation reporting would improve.
Response: Commenters accurately described what information must be
included in the certification or documentation generated by a qualified
CDSM at the time of order, and this is specified in our regulation at
Sec. 414.94(g)(1)(vi). As we move forward in finalizing our approach
for claims-based reporting where CDSMs will be represented through G-
codes, and AUC adherence represented through modifiers, we agree with
commenters that CDSMs should include the G-codes and modifiers in their
certification or documentation. We would like to see CDSMs begin to do
this as the specific G-codes and modifiers become available. And as the
commenters noted, this would seem to be a simple thing for CDSMs to do.
If we do not see CDSMs making such adjustments to their certification
or documentation, we will consider imposing a requirement in
regulation.
Comment: Commenters had varying views of using a UCI to report
consultation information on claims. Some commenters were interested in
moving forward with the UCI requirement when the claims forms are
adjusted to accommodate this new information. Others disagreed on
whether or not a taxonomy with embedded meaning was necessary. Some of
these commenters supported a UCI issued by the qualified CDSM that was
unique to that CDSM. A G-code would also appear on the claim that would
identify which qualified CDSM was consulted and then the UCI would be
used to pair the information with the data in the CDSM specific to that
consultation. Others supported a UCI with a taxonomy with embedded
meaning so one could look at the UCI and know, without accessing
additional information, which CDSM was consulted and the outcome of
that consultation. We also heard from commenters that the UCI could be
lengthy and therefore prone to transcription errors when entering
information on the order or the claim form.
Response: We will continue to consult with stakeholders about the
future possibility of using the UCI.
Comment: Numerous commenters were concerned about the requirements
for claims-based reporting of AUC consultation information when the
claims are not yet able to accommodate new types of information. Most
of these commenters expressed concern about the placement of the UCI
and other commenters pointed out that the furnishing facility claim
does not contain a designated location for the ordering professional's
NPI.
Response: We agree with these concerns and will work with the
appropriate stakeholders to identify a possible future location for a
UCI to be appended to claims. We are not committing to using the UCI at
this time but will be open to exploring the possibility of developing a
UCI that could be appended to claims in the future. We will also work
to better understand and identify a potentially appropriate place on
the furnishing facility claim to include the ordering professional's
NPI, and to understand whether changes to that claim form may be
needed. In the short term we will consider other implementation options
so that fields on the claims are not used improperly.
Comment: Several commenters sought clarification on how, absent a
UCI, AUC claims-based information as reported by the furnishing
professional and facility would be reconciled with the AUC consultation
performed by the ordering professional as there is interest in
establishing best practices for retaining this information. These
commenters requested clarification on who bears responsibility if such
data are not available during an audit, considering that the ordering
professional interacts with the CDSM and provides the information that
the furnishing provider submits on the claim.
Response: It is the responsibility of the ordering professional to
consult AUC and to provide that consultation information to the
furnishing professional; and it is the responsibility of the furnishing
professional and facility to accurately report that information on
claims for applicable imaging services. We will take into account the
specific roles of ordering and furnishing professionals and facilities
as the program develops and we begin to engage in program monitoring
activities.
Comment: Many commenters noted the practice of ``exam
substitution'' permitted by Sections 80.6.2-80.6.4 of Chapter 15 of the
Medicare Benefit Policy Manual when the furnishing

[[Page 59697]]

professional determines a different diagnostic imaging service should
be ordered in certain circumstances and the ordering practitioner is
not available to provide a new order. To this end, commenters
recommended additional proposals to modify the reporting method using
G-codes and modifiers by creating additional modifiers for those orders
that (1) are initiated in one location and furnished at a different
point of service, (2) furnished after a second consultation has
occurred, or (3) are the result of interpretation-only services.
Response: We thank these commenters for their suggestions on
additional modifiers and will consider these recommendations during
implementation.
Based on the public comments we are finalizing the proposal to use
G-codes and modifiers to report consultation information on claims. We
appreciate that commenters pointed out concerns and technical issues
regarding this approach and we will work to address them during
implementation.
e. Significant Hardship Exception
We proposed to revise Sec. 414.94(i)(3) of our regulations to
adjust the significant hardship exception requirements under the AUC
program. We proposed criteria specific to the AUC program and
independent of other programs. An ordering professional experiencing
any of the following when ordering an advanced diagnostic imaging
service would not be required to consult AUC using a qualified CDSM,
and the claim for the applicable imaging service would not be required
to include AUC consultation information. The proposed criteria include:
Insufficient internet access;
EHR or CDSM vendor issues; or
Extreme and uncontrollable circumstances.
Insufficient internet access is specific to the location where an
advanced diagnostic imaging service is ordered by the ordering
professional. EHR or CDSM vendor issues may include situations where
ordering professionals experience temporary technical problems,
installation or upgrades that temporarily impede access to the CDSM,
vendors cease operations, or we de-qualify a CDSM. We expect these
situations to generally be irregular and unusual. Extreme and
uncontrollable circumstances include disasters, natural or man-made,
that have a significant negative impact on healthcare operations, area
infrastructure or communication systems. These could include areas
where events occur that have been designated a federal Emergency
Management Agency (FEMA) major disaster or a public health emergency
declared by the Secretary. Based on 2016 data from the Medicare EHR
Incentive Program and the 2019 payment year MIPS eligibility and
special status file, we estimate that 6,699 eligible clinicians could
submit such a request due to extreme and uncontrollable circumstances
or as a result of a decertification of an EHR, which represents less
than 1 percent of available ordering professionals.
In the CY 2017 PFS final rule, for purposes of the AUC program
significant hardship exceptions, we provided that those who received
significant hardship exceptions in the following categories from Sec.
495.102(d)(4) would also qualify for significant hardship exceptions
for the AUC program:
Insufficient internet Connectivity (as specified in Sec.
495.102(d)(4)(i)).
Practicing for less than 2 years (as specified in Sec.
495.102(d)(4)(ii)).
Extreme and Uncontrollable Circumstances (as specified in
Sec. 495.102(d)(4)(iii)).
Lack of Control over the Availability of CEHRT (as
specified in Sec. 495.102(d)(4)(iv)(A)).
Lack of Face-to-Face Patient Interaction (as specified in
Sec. 495.102(d)(4)(iv)(B)).
In the CY 2018 PFS proposed rule, we proposed to amend the AUC
significant hardship exception regulation to specify that ordering
professionals who are granted reweighting of the Advancing Care
Information (ACI) performance category to zero percent of the final
score for the year under MIPS per Sec. 414.1380(c)(2) due to
circumstances that include the criteria listed in Sec.
495.102(d)(4)(i), (d)(4)(iii), and (d)(4)(iv)(A) and (B) (as outlined
in the bulleted list above) would be excepted from the AUC consultation
requirement during the same year that the re-weighting applies for
purposes of the MIPS payment adjustment. This proposal removed Sec.
495.102(d)(4)(ii), practicing for less than 2 years, as a criterion
since these clinicians are not MIPS eligible clinicians and thus would
never meet the criteria for reweighting of their MIPS ACI performance
category for the year.
In response to public comments, we did not finalize the proposed
changes to the significant hardship exceptions in the CY 2018 PFS final
rule and instead decided further evaluation was needed before moving
forward with any modifications. Our original intention was to design
the AUC significant hardship exception process in alignment with the
process for the Medicare EHR Incentive Program for eligible
professionals, and then for the MIPS ACI (now Promoting
Interoperability) performance category. Under section 1848(a)(7)(A) of
the Act, the downward payment adjustment for eligible professionals
under the Medicare EHR Incentive Program will end in 2018, and we are
unable to continue making reference to a regulation relating to a
program that is no longer in effect. As we have continued to evaluate
both policy options and operational considerations for the AUC
significant hardship exception, we have concluded that the most
appropriate approach, which we consider to be more straightforward and
less burdensome than the current approach, involves establishing
significant hardship criteria and a process that is independent from
other Medicare programs. We also note as we have in the past that the
AUC program is a real-time program with a need for real-time
significant hardship exceptions. This is in contrast to the way
significant hardship exceptions are handled under MIPS where the
hardship might impact some or all of a performance period, or might
impact reporting, both of which occur well before the MIPS payment
adjustment is applied in a subsequent year. We recognize that when a
significant hardship arises, an application process to qualify for an
exception becomes a time consuming hurdle for health care providers to
navigate, and we believe that it is important to minimize the burden
involved in seeking significant hardship exceptions. As such, we
proposed that ordering professionals would self-attest if they are
experiencing a significant hardship at the time of placing an advanced
diagnostic imaging order and such attestation would be supported with
documentation of significant hardship. Ordering professionals attesting
to a significant hardship would communicate that information to the
furnishing professional with the order and it would be reflected on the
furnishing professional's and furnishing facility's claim by appending
a HCPCS modifier. The modifier would indicate that the ordering
professional has self-attested to experiencing a significant hardship
and communicated this to the furnishing professional with the order.
Claims for advanced diagnostic imaging services that include a
significant hardship exception modifier would not be required to
include AUC consultation information.
In addition to the proposals above, we invited the public to
comment on any

[[Page 59698]]

additional circumstances that would cause the act of consulting AUC to
be particularly difficult or challenging for the ordering professional,
and for which it may be appropriate for an ordering professional to be
granted a significant hardship exception under the AUC program.
Although we understand the desire by some for significant hardship
categories unrelated to difficulty in consulting AUC through a CDSM, we
remind readers that circumstances that are not specific to AUC
consultation, such as the ordering professional being in clinical
practice for a short period of time or having limited numbers of
Medicare patients, would not impede clinicians from consulting AUC
through a CDSM as required to meet the requirements of this program.
The following is a summary of the comments we received on the
modifications to the significant hardship exceptions and additional
circumstances for consideration as needing significant hardship
exceptions.
Comment: Some commenters requested that clinicians in the Quality
Payment Program be excepted from or considered automatically in
compliance with the AUC program requirements. Some of these commenters
specified that an exception should apply to all primary care
practitioners, others suggested an exception should apply to all
clinicians in the Quality Payment Program, and several commenters
requested that hospitals and health systems be exempt from reporting
AUC consultation information. One commenter requested that facility and
institutional providers be exempt. Acknowledging that the statutory
language in section 218(b) of the PAMA does not include such an
exception, some of these commenters clarified that CMS should seek
legislative authority to add such an exception.
Response: As added by section 218(b) of the PAMA, section
1834(q)(4)(B) of the Act specifies that AUC consultation information
must be included on all claims for applicable imaging services when
furnished in an applicable setting and paid under an applicable payment
system, which includes the physician fee schedule, prospective payment
system for hospital outpatient department services and the ambulatory
surgical center payment system. Section 1834(q)(4)(C) of the Act also
set forth specific exceptions, including for a service ordered for an
individual with an emergency medical condition, a service ordered for
an inpatient for which payment is made under Medicare Part A, or for a
service ordered by an ordering professional for whom AUC consultation
would result in a significant hardship. In the case of significant
hardship, section 1834(q)(4)(C)(iii) of the Act provides for such
exceptions in situations when the Secretary determines, on a case-by-
case basis, that an ordering professional is exempt because
``consultation with applicable appropriate use criteria would result in
a significant hardship, such as in the case of a professional who
practices in a rural area without sufficient internet access.'' Given
these statutory provisions, blanket exceptions, considered significant
hardships or otherwise, for clinicians in the Quality Payment Program,
for facility or institutional providers, or for hospitals and health
systems, would not be consistent with the statutory requirements. While
we understand that stakeholders may view the AUC program as duplicative
of the Quality Payment Program, we also note that there are specific
and distinct differences between the programs. The AUC program was
established to promote appropriate use of advanced diagnostic imaging
and improve ordering patterns for these services through the
consultation of AUC with real time reporting requirements and payment
implications. While some components of the Quality Payment Program can
involve using AUC and clinical decision support, their use is not
mandatory, and the Quality Payment Program provides numerous options
for participation across all MIPS performance categories. In contrast,
consultation with AUC using a CDSM is required for each order for an
applicable imaging service furnished in an applicable setting and paid
under an applicable payment system under the AUC program. If amendments
are made to the AUC statutory provisions, we will adjust our
regulations throughout Sec. 414.94 accordingly. However, at this time,
we do not have the authority to include exceptions to the AUC program
beyond the scope of those specified in section 1834(q)(4)(C) of the
Act.
Comment: Some commenters requested an additional significant
hardship category based on a low-volume threshold for practices with
low patient volumes, low number of covered services or a low number of
Medicare charges. Some commenters supported this request by noting the
increased cost and burden a small practice would be required to
undertake to meet the requirements of the AUC program.
Response: As noted above, we believe that significant hardships are
reflective of situations that would impede clinicians from consulting
AUC through a CDSM. As the program is structured and given the
availability of qualified CDSMs that are free of charge, we do not
agree that ordering professionals in practices with low patient
volumes, low number of covered services or a low number of Medicare
charges would be impeded from consulting AUC. While we do understand
that participation in the AUC program may result in increased cost and
burden, which could arguably be disproportionate for these types of low
volume practices, we do not have the authority to include exceptions to
the AUC program beyond the scope of those specified in section
1834(q)(4)(C) of the Act.
Comment: Several commenters provided recommendations for other
categories of significant hardship exceptions. One commenter requested
an exception for professionals when the PLE they rely upon becomes
unavailable, and another commenter requested a significant hardship
exception when there is a lack of AUC for the service(s) requiring
consultation or AUC are outdated. Another commenter suggested that new
physicians be excepted from the AUC program and another identified
imaging services ordered as the result of a clinical research protocol
as a potential significant hardship.
Response: We disagree with adding these scenarios to the
significant hardship exceptions under this program. For unavailable
PLEs and AUC, we established specific requirements for both qualified
PLEs and CDSMs that address the two situations included above. First,
qualified CDSMs are required to make available, at a minimum, specified
applicable AUC that reasonably address common and important clinical
scenarios within all priority clinical areas and be able to incorporate
specified applicable AUC from more than one qualified PLE. Should a
qualified PLE cease to exist or otherwise become unavailable, then the
qualified CDSM through which the AUC for that qualified PLE is
consulted would no longer meet the requirements to be a qualified CDSM
(assuming it does not incorporate AUC from another qualified PLE), and
as such, would be de-qualified as a CDSM under this program. As noted
above, de-qualification of a CDSM would be an allowable circumstance
for an ordering professional to attest to a significant hardship due to
EHR or CDSM vendor issues. Second, when an ordering professional
consults a qualified CDSM and there are no AUC applicable to the
service ordered, that information would be reported on the claim as
such. In these situations, the qualified CDSM is required under Sec.
414.94(g)(1)(vi) to

[[Page 59699]]

generate and provide a certification or documentation at the time of
order that documents whether the specified applicable AUC consulted was
not applicable to the service ordered. The ordering professional is
then required to provide that information to the furnishing
professional and facility so that it can be reported as specified under
Sec. 414.94(k). The absence of applicable AUC does not constitute an
exception from the requirement to consult AUC using the qualified CDSM
in an effort to find specified applicable AUC for the order. Third,
qualified PLEs are required to review their AUC regularly and update
them at least annually when appropriate; and qualified CDSMs are
required to make any updated AUC content available within 12 months of
the qualified PLE's update(s). Finally, we do not believe that being a
new physician or conducting clinical research would cause the act of
consulting AUC to be particularly difficult or challenging for the
ordering professional.
Comment: Several commenters revisited previously expressed concerns
about the emergency services exception. The commenters requested
clarification around what constitutes an emergency medical condition.
One commenter suggested that CMS revise the regulatory language to
allow exceptions when an emergency medical condition is suspected for
cases in which clinicians, in their best judgment, believe a patient
may be experiencing a medical emergency at the time of order. This
commenter noted that this approach was the intent of section 218(b) of
the PAMA as explained by a member of Congress who was involved in
drafting the statutory language, and that the reference to section
1867(e) of the Act instead of section 1867(a) of the Act was an
inadvertent drafting error. One commenter requested that CMS delay
requiring AUC consultations in the emergency department until the
ambiguity over what services are considered emergency services is
resolved.
Response: Section 1834(q)(4)(C)(i) of the Act provides for an
exception to the AUC consultation and reporting requirements in the
case of a service ordered for an individual with an emergency medical
condition as defined in section 1867(e)(1) of the Act, not section
1867(a) of the Act as the commenter suggests. The regulation reflects
the current statutory language and we will not amend our regulation in
response to these comments. As stated in our response to comments in
the CY 2017 PFS final rule with comment, we agree that exceptions
granted for an individual with an emergency medical condition include
instances where an emergency medical condition is suspected, but not
yet confirmed. This may include, for example, instances of severe pain
or severe allergic reactions. In these instances, the exception is
applicable even if it is determined later that the patient did not in
fact have an emergency medical condition.
Comment: Many commenters generally supported the proposed
significant hardship categories and self-attestation approach, with one
commenter specifically encouraging oversight of AUC and the use of
significant hardship exceptions. However, many other commenters
challenged the proposed approach to annotating the significant hardship
self-attestation on every Medicare claim. Specifically, they requested
that a blanket exception or single attestation be applied over a period
of time to avoid increased burden of communicating and reporting a
significant hardship attestation on every advanced diagnostic imaging
order, and suggested using a significant hardship exception modifier on
the subsequent claim(s) after the single attestation. One commenter
noted that the approach as proposed by CMS is more burdensome than
requiring the use of an applications process.
Response: Because the AUC program requires real time reporting on
Medicare claims, we believe the best way to ensure clinicians have the
ability and flexibility to use the significant hardships allowable
under this program is to establish a mechanism for real time
application of significant hardship attestations. To accomplish this,
inclusion of the relevant significant hardship modifier on each
Medicare claim offers the most straightforward approach, enabling
ordering professionals to use a significant hardship exception as
needed and without more complicated, time consuming steps that could
result in a delay in the transmission, acceptance and processing of the
imaging order for the ordering and furnishing professionals, as well as
a delay in care for the patient. We note that applying a blanket
exception for a specific period of time for ordering professionals
based on a single significant hardship attestation would introduce a
level of complexity and burden to the process that was not identified
by requestors. Following such a single attestation, furnishing
professionals (as well as CMS) would need to keep track of which
ordering professionals had attested to a significant hardship as well
as the period of time applicable to each attestation every time an
order is received and a claim is prepared, submitted and processed. We
disagree with commenters that inclusion of significant hardship
information on each imaging order and subsequent claim imposes
extensive burden, or that other approaches would be less burdensome and
achieve the same goal of allowing for a real time significant hardship
exception process under the real time AUC program.
Comment: Many commenters posed specific requests for clarification
around the proposed significant hardship exception categories. One
commenter requested further clarity and a broader application of
insufficient internet access and extreme and uncontrollable
circumstances to include, respectively, situations out of the control
of the ordering professional like slow internet and no physical access
to the CDSM, lost CDSM usernames and passwords and other situations
preventing an ordering professional from consulting at the time of the
patient encounter. Other commenters requested clarification around how
orders would be made during downtime and how and when to document the
significant hardship and by whom. A few commenters did not understand
how de-certification of an EHR would qualify as a significant hardship
since there are no certification requirements related to the AUC
program. Others requested further information on how hardship
information must be reported on the claim, specific information on
coding a significant hardship, how to handle emergency situations and
what to report when orders are changed.
Response: We appreciate the comments submitted requesting further
clarification around exactly how significant hardship exceptions will
be operationalized. We note that many of the questions posed are
specific to claims reporting details. We expect to provide further
details and clarification in the claims processing instructions that we
expect to release following the final rule.
We describe insufficient internet access as specific to the
location where an advanced diagnostic imaging service is ordered by the
ordering professional. To further clarify, we note that in addition to
ordering imaging services in an area without sufficient internet
access, a significant hardship may apply when ordering professionals
would face insurmountable barriers to obtaining infrastructure to have
internet access (that is, lack of broadband). We do not believe that
occasions of slow internet constitute a significant hardship.

[[Page 59700]]

We describe EHR or CDSM vendor issues as situations where ordering
professionals experience temporary technical problems, installation or
upgrades that temporarily impede access to the CDSM, vendors cease
operations, or we de-qualify a CDSM and note that we expect these
situations to be irregular and unusual. De-certification of an EHR
would qualify as a significant hardship when the ordering
professionals' qualified CDSM is integrated into their EHR, and the
ordering professional's access to the CDSM is temporarily impeded due
to installation issues associated with switching to a new vendor. We do
not agree that losing CDSM usernames and passwords constitutes a
significant hardship under the AUC program. Self-attestation for this
significant hardship should be used as needed when the situations
described above occur. We have not established limitations around using
the EHR or CDSM vendor issues or the other significant hardship
exceptions, but may monitor the use of these exceptions to ensure
misuse or overuse does not become a problem.
We describe extreme and uncontrollable circumstances to include
disasters, natural or man-made, that have a significant negative impact
on healthcare operations, area infrastructure or communication systems.
We also explain these may include areas where events occur that have
been designated by FEMA as a major disaster or a public health
emergency declared by the Secretary. To further clarify, these
circumstances are events that are entirely outside the control of the
ordering professional that prevent the ordering professional from
consulting AUC through a qualified CDSM. We believe the hardship
criteria under this program are similar to other programs such as MIPS
and Promoting Interoperability, particularly the flexibility that is
given to clinicians to identify extreme and uncontrollable
circumstances.
Comment: Several commenters submitted a variety of additional
comments and questions about the proposed significant hardship
exceptions. One commenter questioned why the AUC hardships are not
completely aligned with Quality Payment Program hardships. One stated
that interpretation-only services do not need to include documentation
of AUC consultation because professionals with no face-to-face
encounters are excepted. One commenter questioned why an ordering
professional with a significant hardship exception would need to
communicate AUC consultation information, and suggested that they
should only need to communicate the exception information to the
furnishing professional and facility. A few commenters recommended that
furnishing professionals should be held harmless when ordering
professionals self-attest to experiencing a significant hardship.
Response: As explained above, the AUC program requires real time
reporting of information on the Medicare claims for payment purposes.
The Quality Payment Program is not a real time program but instead uses
data from prior performance years to determine status and potential
payment adjustments in future years. This distinct and significant
difference, along with statutory differences between the programs,
necessitates a separate significant hardship exception approach and
process for the AUC program. As discussed throughout this section, we
have made efforts to align significant hardship exception concepts with
the Quality Payment Program as closely as possible; however, we are
unable to achieve full alignment due to the innate programmatic
differences. For ordering professionals without face-to-face patient
interactions, we did not include this circumstance in our proposals and
do not provide for such an exception in this final rule. The degree of
patient interaction does not create in itself a significant hardship to
consultation with applicable AUC. For communicating consultation
information on the imaging order when a significant hardship is
experienced, the commenter is correct. No AUC consultation information
is to be communicated when an ordering professional self-attests to
experiencing a significant hardship and communicates that on the order.
This confusion likely arose from language that we inadvertently
included in the preamble and have corrected for the final rule. Section
1834(q)(4)(B) of the Act requires certain information to be included on
the claim for applicable imaging services under this program. As long
as the furnishing professional and facilities correctly include the
required information or append the appropriate hardship modifier, the
claims will not be denied for failing to include AUC consultation
information, and the furnishing professionals and facilities are not
held responsible for the self-attestation made by the ordering
professional. As noted above, we may monitor the use of these
exceptions to ensure misuse or overuse does not become a problem, with
the understanding that they reflect the ordering professional's self-
attestation, not a representation made by the furnishing professional
or facility. It is not appropriate for furnishing professionals or
facilities to append significant hardship modifiers at their
discretion; and we note that support for the use of such a modifier
should be included by the ordering professional in the patient's
medical record.
After considering the public comments, we are finalizing the
significant hardship categories of insufficient internet access, EHR or
CDSM vendor issues, and extreme and uncontrollable circumstances and
updating this language in Sec. 414.94(i)(3) of our regulations. We are
also finalizing our proposal to allow ordering professionals
experiencing a significant hardship to self-attest and include that
information on the order for the advanced diagnostic imaging service,
which the furnishing professional or facility would then communicate on
the Medicare claim for the service by appending a HCPCS modifier
identifying the ordering professional's self-attested significant
hardship category.
f. Identification of Outliers
As previously mentioned, the fourth component of the AUC program
specified in section 1834(q)(5) of the Act, is the identification of
outlier ordering professionals. In our efforts to start a dialogue with
stakeholders, we invited the public to submit their ideas on a possible
methodology for the identification of outlier ordering professionals
who would eventually be subject to a prior authorization process when
ordering advanced diagnostic imaging services. Specifically, we
solicited comments on the data elements and thresholds that we should
consider when identifying outliers. We also intend to perform and use
analysis to assist us in developing the outlier methodology for the AUC
program. Our existing prior authorization programs generally do not
specifically focus on outliers. We are interested in hearing ideas from
the public on how outliers could be determined for the AUC program.
Because we would be concerned about data integrity and reliability, we
do not intend to include data from the educational and operations
testing period in CY 2020 in the analysis used to develop our outlier
methodology. Since we intend to evaluate claims data to inform our
methodology we expect to address outlier identification and prior
authorization more fully in CY 2022 or 2023 rulemaking. We appreciate
the feedback received from public commenters and as noted above, we

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expect to solicit additional public comment to inform our methodology
through rulemaking before finalizing our approach.
5. Summary
We appreciate the commenters that continue to provide their
perspective and feedback on this program. Based on those comments we
will finalize the following:
We will finalize as proposed to add IDTFs to the definition of
applicable settings under Sec. 414.94(b) of this program. We will also
finalize as proposed that furnishing professionals and all furnishing
entities are required to report AUC consultation information on the
claim as specified under Sec. 414.94(k). In addition we will finalize
as proposed the significant hardship exception criteria and process
under Sec. 414.94(i)(3) to be specific to the AUC program and
independent of other Medicare programs.
We will not finalize as proposed the proposal to allow the AUC
consultation, when not personally performed by the ordering
professional, to be performed by auxiliary personnel incident to the
ordering professional's services. Rather we are finalizing under Sec.
414.94(j)(2) that when delegated by the ordering professional, clinical
staff under the direction of the ordering professional may perform the
AUC consultation with a qualified CDSM.
Additionally, we will move forward with plans to use G-codes and
modifiers to report AUC consultation information on the Medicare
claims.
We will continue to post information on our website for this
program, accessible at www.cms.gov/Medicare/Quality-Initiatives-
Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/
index.html.

E. Medicaid Promoting Interoperability Program Requirements for
Eligible Professionals (EPs)

1. Background
Sections 1903(a)(3)(F) and 1903(t) of the Act provide the statutory
basis for the incentive payments made to Medicaid EPs and eligible
hospitals for the adoption, implementation, upgrade, and meaningful use
of CEHRT. We have implemented these statutory provisions in prior
rulemakings to establish the Medicaid Promoting Interoperability
Program.
Under sections 1848(o)(2)(A)(iii) and 1903(t)(6)(C)(i)(II) of the
Act, and the definition of ``meaningful EHR user'' in regulations at
Sec. 495.4, one of the requirements of being a meaningful EHR user is
to successfully report the clinical quality measures selected by CMS to
CMS or a state, as applicable, in the form and manner specified by CMS
or the state, as applicable. Section 1848(o)(2)(B)(iii) of the Act
requires that in selecting electronic clinical quality measures (eCQMs)
for EPs to report under the Promoting Interoperability Program, and in
establishing the form and manner of reporting, the Secretary shall seek
to avoid redundant or duplicative reporting otherwise required. We have
taken steps to align various quality reporting and payment programs
that include the submission of eCQMs.
In the ``Medicare Program; Hospital Inpatient Prospective Payment
Systems for Acute Care Hospitals and the Long-Term Care Hospital
Prospective Payment System and Policy Changes and Fiscal Year 2018
Rates; Quality Reporting Requirements for Specific Providers; Medicare
and Medicaid Electronic Health Record (EHR) Incentive Program
Requirements for Eligible Hospitals, Critical Access Hospitals, and
Eligible Professionals; Provider-Based Status of Indian Health Service
and Tribal Facilities and Organizations; Costs Reporting and Provider
Requirements; Agreement Termination Notices'' final rule (82 FR 37990,
38487) (hereafter referred to as the ``FY 2018 IPPS/LTCH PPS final
rule''), we established that, for 2017, Medicaid EPs would be required
to report on any six eCQMs that are relevant to the EP's scope of
practice. In proposing and finalizing that change, we indicated that it
is our intention to align eCQM requirements for Medicaid EPs with the
requirements of Medicare quality improvement programs, to the extent
practicable.
2. eCQM Reporting Requirements for EPs Under the Medicaid Promoting
Interoperability Program for 2019
CMS annually reviews and revises the list of eCQMs for each MIPS
performance year to reflect updated clinical standards and guidelines.
In section III.I.3.h.(2)(b)(i) of this final rule, we amend the list of
available eCQMs for the CY 2019 performance period. To keep eCQM
specifications current and minimize complexity, we proposed to align
the eCQMs available for Medicaid EPs in 2019 with those available for
MIPS eligible clinicians for the CY 2019 performance period (83 FR
35871). Specifically, we proposed that the eCQMs available for Medicaid
EPs in 2019 would consist of the list of quality measures available
under the eCQM collection type on the final list of quality measures
established under MIPS for the CY 2019 performance period.
We explained that we believed that this proposal would be
responsive to stakeholder feedback supporting quality measure alignment
between MIPS and the Medicaid Promoting Interoperability Program for
EPs, and that it would encourage EP participation in the Medicaid
Promoting Interoperability Program by allowing those that are also MIPS
eligible clinicians the ability to report the same eCQMs as they report
for MIPS in 2019. In addition, we explained that we believed that
aligning the eCQMs available in each program would ensure the most
uniform application of up-to-date clinical standards and guidelines
possible.
We explained that we anticipated that this proposal would reduce
burden for Medicaid EPs by aligning the requirements for multiple
reporting programs, and that the system changes required for EPs to
implement this change would not be significant, particularly in light
of our belief that many EPs will report eCQMs to meet the quality
performance category of MIPS and therefore should be prepared to report
on the available eCQMs for 2019. We explained that we expected that
this proposal would have only a minimal impact on states, by requiring
minor adjustments to state systems for 2019 to maintain current eCQM
lists and specifications.
We also requested comments on whether in future years of the
Medicaid Promoting Interoperability Program beyond 2019, we should
include all e-specified measures from the core set of quality measures
for Medicaid and the Children's Health Insurance Program (CHIP) (the
Child Core Set) and the core set of health care quality measures for
adults enrolled in Medicaid (Adult Core Set) (hereinafter together
referred to as ``Core Sets'') as additional options for Medicaid EPs.
Sections 1139A and 1139B of the Act require the Secretary to
identify and publish core sets of health care quality measures for
child Medicaid and CHIP beneficiaries and adult Medicaid beneficiaries.
These measure sets are required by statute to be updated annually and
are voluntarily reported by states to CMS. These core sets comprise
measures that specifically focus on populations served by the Medicaid
and CHIP programs and are of particular importance to their care.
Several of these Core Set measures are included in the MIPS eCQM list,
but some are not. We explained that we believe that including, as eCQM
reporting options for Medicaid EPs, the e-specified measures from the
Core Sets that are not

[[Page 59702]]

also on the MIPS eCQM list would increase EP utilization of these
measures and provide states with better data to report. At this time,
the only measure within the Core Sets that would not be available as an
option for Medicaid EPs in 2019 (because it is not on the MIPS eCQM
list for Performance Year 2019) is NQF-1360, ``Audiological Diagnosis
No Later Than 3 Months of Age.'' However, as these Core Sets are
updated annually, in future years there may be other eCQMs that would
not be on the MIPS eCQM list, and that could be included.
For 2019, we proposed that Medicaid EPs would report on any six
eCQMs that are relevant to their scope of practice, regardless of
whether they report via attestation or electronically. After we removed
the NQS domain requirements for Medicaid EPs' 2017 eCQM submissions in
the FY 2018 IPPS/LTCH PPS final rule, we have found that allowing EPs
to report on any six quality measures that are relevant to their
practice has increased EPs' flexibility to report pertinent data. In
addition, this policy of allowing Medicaid EPs to report on any six
measures relevant to their scope of practice would generally align with
the MIPS data submission requirement for eligible clinicians using the
eCQM collection type for the quality performance category, which is
established at Sec. 414.1335(a)(1). MIPS eligible clinicians who elect
to submit eCQMs must generally submit data on at least six quality
measures, including at least one outcome measure (or, if an applicable
outcome measure is not available, one other high priority measure). We
refer readers to Sec. 414.1335(a) for the data submission criteria
that apply to individual MIPS eligible clinicians and groups that elect
to submit data with other collection types.
We proposed that for 2019 the Medicaid Promoting Interoperability
Program would adopt the MIPS requirement that EPs report on at least
one outcome measure (or, if an outcome measure is not available or
relevant, one other high priority measure).
We also requested comments on how high priority measures should be
identified for Medicaid EPs. We proposed (83 FR 35872) to use all three
of the following methods to identify which of the available measures
are high priority measures, but invited comments on other
possibilities.
1. We proposed to use the same set of high priority measures for
EPs participating in the Medicaid Promoting Interoperability Program
that the MIPS program has identified for eligible clinicians. As
discussed in section III.I.3.h.(2)(b)(i) of this final rule, we
proposed to amend Sec. 414.1305 to revise the definition of high
priority measure for purposes of MIPS to mean an outcome (including
intermediate-outcome and patient-reported outcome), appropriate use,
patient safety, efficiency, patient experience, care coordination, or
opioid-related quality measure, beginning with the 2021 MIPS payment
year.
2. For 2019, we also proposed to identify as high priority measures
the available eCQMs that are included in the previous year's Core Sets
and that are also included on the MIPS list of eCQMs. We explained that
because the Core Sets are released at the beginning of each year, it
would not be possible to update the list of high-priority eCQMs with
those added to the current year's Core Sets. We also explained that CMS
has already identified the measures included in the Core Sets as ones
that specifically focus on populations served by the Medicaid and CHIP
programs and are particularly important to their care. The eCQMs that
would be available for Medicaid EPs to report in 2019, that are both
part of the Core Sets and on the MIPS list of eCQMs, and that would be
considered high priority measures under our proposal are: CMS2,
``Preventive Care and Screening: Screening for Depression and Follow-Up
Plan''; CMS4, ``Initiation and Engagement of Alcohol and Other Drug
Dependence Treatment''; CMS122, ``Diabetes: Hemoglobin A1c (HbA1c) Poor
Control (>9%)''; CMS125, ``Breast Cancer Screening''; CMS128, ``Anti-
depressant Medication Management''; CMS136, ``Follow-Up Care for
Children Prescribed ADHD Medication (ADD)''; CMS153, ``Chlamydia
Screening for Women''; CMS155, ``Weight Assessment and Counseling for
Nutrition and Physical Activity for Children and Adolescents''; and
CMS165, ``Controlling High Blood Pressure.''
3. We also proposed to give each state the flexibility to identify
which of the available eCQMs selected by CMS are high priority measures
for Medicaid EPs in that state, with review and approval from CMS,
through their State Medicaid HIT Plans (SMHP), similar to the
flexibility granted states to modify the definition of Meaningful Use
at Sec. 495.332(f). We explained that we believe this proposal would
give states the ability to identify as high priority those measures
that align with their state health goals or other programs within the
state. We proposed to amend Sec. 495.332(f) to provide for this state
flexibility to identify high priority measures.
We proposed that any eCQMs identified via any of these mechanisms
be considered to be high priority measures for EPs participating in the
Medicaid Promoting Interoperability Program for 2019.
We also proposed that the eCQM reporting period for EPs in the
Medicaid Promoting Interoperability Program would be a full CY in 2019
for EPs who have demonstrated meaningful use in a prior year, in order
to align with the corresponding performance period in MIPS for the
quality performance category. We explained that we continue to align
Medicaid Promoting Interoperability Program requirements with
requirements for other CMS quality programs, such as MIPS, to the
extent practicable, to reduce the burden of reporting different data
for separate programs. In addition, we explained that we have found
that clinical quality data from an entire year reporting period is
significantly more useful than partial year data for quality
measurement and improvement because it gives states a fuller picture of
a health care provider's care and patient outcomes. We proposed that
the eCQM reporting period for Medicaid EPs demonstrating meaningful use
for the first time, which was established in the final rule entitled
``Medicare and Medicaid Programs; Electronic Health Record Incentive
Program-Stage 3 and Modifications to Meaningful Use in 2015 Through
2017'' (80 FR 62762) (hereafter referred to as ``Stage 3 final rule''),
would remain any continuous 90-day period (80 FR 62892).
We explained that we will adjust future years' requirements for
reporting eCQMs in the Medicaid Promoting Interoperability Program
through rulemaking, and will continue to align the quality reporting
requirements, as logical and feasible, to minimize EP burden.
Comment: Many commenters stated that they support the alignment of
the eCQMs available for Medicaid EPs in 2019 with those available for
MIPS eligible clinicians for the CY 2019 performance period. These
commenters stated that alignment between the two programs helps reduce
health care provider reporting burden. In addition, several commenters
noted that the MIPS eCQM list is geared toward adults and that
including measures from the Child Core Set in future years, after 2019,
would add measures that are more applicable to certain specialties that
serve Medicaid and CHIP beneficiaries, such as pediatricians and
pediatric dentists.
Response: We appreciate these comments, and we continue to look for

[[Page 59703]]

opportunities to align programs, make measures more relevant to
Medicaid EPs, and reduce reporting burden when possible.
Comment: Several commenters supported the proposal to include any
e-specified measures from the Adult Core Set and Child Core Set that
are not also on the MIPS eCQM list, in order to align with other CMS
programs, as well as to provide a wider variety of measures that are
specifically applicable to Medicaid EPs.
Response: We agree that the measures included in the Adult Core Set
and the Child Core Set are targeted toward Medicaid patients and
Medicaid health care providers. These Core Sets are tools states can
use to monitor and improve the quality of health care provided to
Medicaid and CHIP enrollees. Although under statute, state reporting on
these measure sets is voluntary, we aim to increase the number of
states reporting on a uniform set of measures and to support states in
using these measures to drive quality improvement for the beneficiaries
they serve.
Comment: One commenter stated that the e-specified Adult Core Set
and Child Core Set measures that are not also on the MIPS eCQM list
should not be included in future years of the Medicaid Promoting
Interoperability Program beyond 2019 because the Medicaid Promoting
Interoperability Program is approaching the final years of
participation and Medicaid EPs are already aware of the requirements
they need to meet to be a meaningful EHR user. In addition, the same
commenter stated that adding additional measures from the Core Sets
would create a large burden on all states to update their attestation
systems for the one or two remaining participation years.
Response: We appreciate this comment, but point out that the burden
to states would be no greater than including any additional measures
that may be added to the MIPS eCQM set in future years, if CMS
continues to align the MIPS and Medicaid Promoting Interoperability
Program eCQM requirements. We also point out that many of the positive
comments regarding this proposal came from states that appreciated the
proposal to align with other CMS reporting requirements. Those
commenters did not indicate that such a requirement would impose a
significant burden on states.
After careful consideration of the comments, we are finalizing
without change our proposal to amend the list of available eCQMs for
the CY 2019 performance period. To keep eCQM specifications current and
minimize complexity, we are aligning the eCQMs available for Medicaid
EPs in 2019 with those available for MIPS eligible clinicians for the
CY 2019 performance period. Specifically, the eCQMs available for
Medicaid EPs in 2019 will consist of the list of quality measures
available under the eCQM collection type on the final list of quality
measures established under MIPS for the CY 2019 performance period.
We did not propose to include the e-specified measures within the
Adult Core Set and Child Core Set that are not also on the MIPS eCQM
list for eCQM reporting in the Medicaid Promoting Interoperability
Program in 2019, due to timing and logistical feasibility. However, we
intend to reevaluate whether to add these measures when proposing eCQM
reporting requirements for the Medicaid Promoting Interoperability
Program for 2020 and beyond.
Comment: Many commenters stated their support for aligning the
Medicaid Promoting Interoperability Program with the MIPS requirement
that eligible clinicians who elect to submit eCQMs must generally
submit data on at least six quality measures, including at least one
outcome measure (or, if an applicable outcome measure is not available,
one other high priority measure).
Response: We thank these commenters and we will continue to look
for opportunities to align the programs and reduce reporting burden
when possible.
Comment: One commenter stated that there are relatively few
pediatric-appropriate measures in the Medicaid Promoting
Interoperability Program and MIPS, and therefore recommended that CMS
provide specific clarification that pediatric providers would not be
held responsible for adult measures that are not necessarily applicable
to pediatrics.
Response: We acknowledge that not all Medicaid EPs may find six
measures applicable to their scope of practice. Therefore, we note that
our policy continues to allow Medicaid EPs to report eCQMs with zero in
the denominator, which indicates that they have no data on that eCQM in
their EHR from the reporting period. If fewer than six measures are
relevant to a Medicaid EP's scope of practice, he or she may submit
``zero denominator'' eCQMs that his or her CEHRT is able to calculate
to meet the requirement to report six measures. If an EP's CEHRT
contains no data on a specific eCQM, when states are auditing EP's
submissions, it may create a rebuttable presumption that that measure
falls outside of the EP's scope of practice. However, unless they
cannot otherwise report on six measures, we encourage EPs to report on
eCQMs that contain data, which are more likely to be within their scope
of practice, instead of reporting eCQMs with a zero denominator.
Comment: One commenter stated that some specialists may have
difficulty finding an outcome or high priority measure applicable to
their scope of practice. The commenter also noted that this difficulty
is alleviated under MIPS with the group reporting option, which is not
available under the Medicaid Promoting Interoperability Program.
Response: In light of this concern, we now explain that if no
outcome or high priority measures apply to a Medicaid EP's scope of
practice and there is no data for any of the outcome or high priority
measures reportable by his or her CEHRT, he or she may report on six
non-outcome and non-high priority measures that are applicable to his
or her scope of practice.
Comment: One commenter inquired as to a state's responsibility for
auditing the eCQMs a Medicaid EP submits, how a state would ensure that
the reported eCQMs are within the EP's scope of practice, and how a
state would know whether there was an unselected relevant outcome or
high priority measure.
Response: Under Sec. 495.368, states are required to combat fraud
and abuse and ensure that incentive payments are made properly per the
requirements of the program, including the eCQM reporting requirements.
In regard to this particular requirement, we believe that Medicaid EPs
are in the best position to determine which measures are applicable to
their scope of practice, not the state. Therefore, when verifying EPs'
submissions, either at prepayment or during a post-payment audit,
states should give Medicaid EPs the widest reasonable latitude to
determine which eCQMs are relevant to their scope of practice. For
instance, an EP should be able to meet the eCQM reporting requirements
by submitting non-zero data for six relevant eCQMs, including one
outcome or high-priority measure, regardless of whether there may be an
unselected eCQM more relevant to his or her practice. That is, as we
noted above, we do not think EPs should be reporting on eCQMs with a
zero denominator unless that is the only way the EP can report on six
measures. We encourage states to provide technical assistance to
Medicaid EPs and to design their attestation systems in such a way that
will assist EPs to meet this program requirement, and that will help
avoid recouping incentive payments.
After careful consideration of the comments, we are finalizing our

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proposal that for 2019, Medicaid EPs will report on any six eCQMs that
are relevant to the EP's scope of practice, regardless of whether they
report via attestation or electronically. We are also finalizing the
proposal that for 2019 the Medicaid Promoting Interoperability Program
will adopt the MIPS requirement that EPs report on at least one outcome
measure (or, if an applicable outcome measure is not available or
relevant, one other high priority measure). Additionally, in response
to comments summarized above, we now explain that if no outcome or high
priority measure is relevant to a Medicaid EP's scope of practice, he
or she may report on any six eCQMs that are relevant.
Comment: Some commenters approved of our proposal to allow states
to indicate which eCQMs are high priority measures for that state's
Medicaid agency.
Response: We thank these commenters for their comments.
Comment: A few commenters opposed offering states the flexibility
to identify high priority eCQMs because it can cause additional cost to
states for technology updates, and additional burden for vendors to
customize and make software updates in a short timeframe. They also
commented that having differences among states can cause burden on
Medicaid EPs.
Response: We do not believe that this flexibility and variation
between states will cause any additional burden for states, vendors or
Medicaid EPs. Allowing states to identify their own high priority
measures is entirely optional. If a state chooses not to identify
additional high priority measures, the state would need to take no
additional action. Furthermore, we expect that providing this option
for states will reduce Medicaid EP burden, as it will give EPs a wider
range of options to meet the requirement that they report on at least
one outcome measure, or on at least one high priority measure if an
outcome measure is not available or relevant. Additionally, as we
explain above, if no outcome or priority measure is relevant to a
Medicaid EP's scope of practice, he or she may instead report on any
six measures that are relevant.
Finally, this proposal should not increase burden on CEHRT vendors.
States may select high priority measures only from the list of eCQMs
that are already available for Medicaid EPs to meet the requirements of
the program. Medicaid EPs are not required to select any of their
state-specific high priority measures. Therefore, the CEHRT need not
vary between states, but must be able to calculate and report on at
least one outcome measure (or, if an applicable outcome measure is not
available or relevant, one other high priority measure) relevant to the
provider's scope of practice, whether or not that is a state-specific
high priority measure.
We received no comments on the first and second methods of
identifying high priority measures for the Medicaid Promoting
Interoperability Program. After careful consideration of the comments
on our proposed approach to how high priority measures would be
identified, we are finalizing it without modification.
Comment: Several commenters stated their support for aligning the
eCQM reporting period for EPs in the Medicaid Promoting
Interoperability Program with the corresponding performance period in
MIPS, because they agreed this proposal would reduce EP burden. In
addition, commenters noted that consistency with previous years will
reduce confusion among EPs.
Response: We appreciate these comments and will continue to align
when possible.
Comment: Several commenters urged CMS to adopt a 90-day eCQM
reporting period within CY 2019 for all Medicaid EPs. A couple
commenters indicated that the transition between 2014 Edition and 2015
Edition CEHRT during the year may create difficulty for Medicaid EPs to
report a full year of data.
Response: We acknowledge that many Medicaid EPs might be upgrading
or implementing new CEHRT in 2019. However, Medicaid EPs frequently
upgrade or implement new CEHRT, regardless of the reporting year.
Regardless of what CEHRT the EP used during the eCQM reporting period,
the data that Medicaid EPs are required to report for eCQMs is a
snapshot based on the data within the CEHRT, taken at the time of
attestation, for the reporting period. Medicaid EPs are only
responsible for reporting exactly the data that their CEHRT produces.
As certified, 2015 Edition CEHRT should accurately calculate and report
the eCQM data for the full reporting period, in accordance with the
relevant certification requirements at 45 CFR 170.315(c), even if that
2015 Edition CEHRT was not implemented for the entire reporting period.
Vendors should ensure that their CEHRT is performing in accordance with
relevant 2015 Edition Certification requirements as defined by the
Office of the National Coordinator for Health IT. The reporting process
for EPs should be no different regardless of the length of the
reporting period.
After careful consideration of the comments, we are finalizing
without change our proposal that the eCQM reporting period for EPs in
the Medicaid Promoting Interoperability Program will be a full CY in
2019 for EPs who have demonstrated meaningful use in a prior year, in
order to align with the corresponding performance period in MIPS for
the quality performance category. The eCQM reporting period for
Medicaid EPs demonstrating meaningful use for the first time, which was
established in the Stage 3 final rule, will remain any continuous 90-
day period (80 FR 62892).
3. Proposed Revisions to the EHR Reporting Period and eCQM Reporting
Period in 2021 for EPs Participating in the Medicaid Promoting
Interoperability Program
In the July 28, 2010 final rule titled ``Medicare and Medicaid
Programs; Electronic Health Record Incentive Program'' at 75 FR 44319,
we established that, in accordance with section 1903(t)(4)(A)(iii) of
the Act, in no case may any Medicaid EP receive an incentive after 2021
(see Sec. 495.310(a)(2)(v)). Therefore, December 31, 2021 is the last
date that states could make Medicaid Promoting Interoperability Program
payments to Medicaid EPs (other than pursuant to a successful appeal
related to 2021 or a prior year).
For states to make payments by that deadline, there must be
sufficient time after EHR and eCQM reporting periods end for Medicaid
EPs to attest to states, for states to conduct their prepayment
processes, and for states to issue payments. Therefore, we proposed to
amend Sec. 495.4 to provide that the EHR reporting period in 2021 for
all EPs in the Medicaid Promoting Interoperability Program would be a
minimum of any continuous 90-day period within CY 2021, provided that
the end date for this period falls before October 31, 2021, to help
ensure that the state can issue all Medicaid Promoting Interoperability
Program payments on or before December 31, 2021. Similarly, we proposed
to change the eCQM reporting period in 2021 for EPs in the Medicaid
Promoting Interoperability Program to a minimum of any continuous 90-
day period within CY 2021, provided that the end date for this period
falls before October 31, 2021, to help ensure that the state can issue
all Medicaid Promoting Interoperability Program payments on or before
December 31, 2021.
We explained that we understand that the October 31, 2021 date
might not provide some states with sufficient time to process payments
by December 31,

[[Page 59705]]

2021. We also explained that we believe that states are best positioned
to determine the last possible date in CY 2021 by which the EHR or eCQM
reporting periods for Medicaid EPs must end, and the deadline for
receiving EP attestations, so that the state is able to issue all
payments by December 31, 2021. Therefore, we proposed to allow states
the flexibility to set alternative, earlier final deadlines for EHR or
eCQM reporting periods for Medicaid EPs in CY 2021, with prior approval
from us, through their State Medicaid HIT Plans (SMHP). If a state
establishes an alternative, earlier date within CY 2021 by which all
EHR or eCQM reporting periods in CY 2021 must end, Medicaid EPs in that
state would continue to have a reporting period of a minimum of any
continuous 90-day period within CY 2021. The end date for the reporting
period would have to occur before the day of attestation, which must
occur prior to the final deadline for attestations established by their
state. We proposed to amend Sec. 495.332(f) to provide for this state
flexibility to identify an alternative date by which all EHR reporting
periods or eCQM reporting periods for Medicaid EPs in CY 2021 must end.
We believe there is no reason why a state would need to set a date
by which EHR reporting periods and eCQM reporting periods must end for
Medicaid EPs that is earlier than the day before that state's
attestation deadline for EPs. Doing so would restrict Medicaid EPs'
ability to select EHR and eCQM reporting periods. Therefore, we
proposed that any alternative deadline for CY 2021 EHR and eCQM
reporting periods set by a state may not be any earlier than the day
prior to the attestation deadline for Medicaid EPs attesting to that
state.
The following is a summary of the comments we received regarding
these proposals.
Comment: Multiple commenters stated their support for the proposal
that the EHR reporting period in 2021 for all EPs in the Medicaid
Promoting Interoperability Program would be a minimum of any continuous
90-day period within CY 2021, provided that the end date for this
period falls before October 31, 2021. They agreed that this would help
ensure that states can issue all Medicaid Promoting Interoperability
Program payments on or before December 31, 2021. They also stated their
support of the 90-day period for eCQM reporting, and for state
flexibility to set earlier final deadlines for EHR or eCQM reporting
periods for Medicaid EPs in CY 2021.
Response: We appreciate these comments and thank the commenters for
their input.
Comment: A commenter pointed out that the earlier in the year a
state sets the reporting period and attestation deadline, the more
burden is put on Medicaid EPs to attest after a 90 day EHR and eCQM
reporting period in 2021. They requested that we balance the burden
between states and Medicaid EPs by setting a regulatory date before
which a state could not set an attestation deadline.
Response: The commenters raise important questions about whether
burden should be reduced on state staff and systems to the disadvantage
of Medicaid EPs. Therefore, while we are finalizing the proposed
policies without change, we are considering whether to propose in
future rulemaking that no state may set a reporting period deadline for
CY 2021 that is earlier than June 30, 2021 or an attestation deadline
that is earlier than July 1, 2021. In the meanwhile, we welcome input
from states and other interested parties on whether any state would
need more than 6 months to process Medicaid EPs' attestations, perform
the required prepayment validations, and disburse incentive payments.
Comment: One commenter requested that CMS provide outreach and
educational materials to providers about the 2021 deadline, as they
anticipate confusion.
Response: We will work with State Medicaid Agencies and provider
communities to ensure that outreach and education are provided about
the final attestation deadline and the end of the program.
Comment: Some commenters requested that CMS consider making the
eCQM reporting period any 90 days within CY 2020 as well. They note
that a full year reporting period may create significant backlogs of
2020 and 2021 attestations in 2021 that may create difficulty for
states to issue payments by the statutory deadline.
Response: We understand that this is a concern. We will continue to
monitor this issue as we develop proposed rules for the Medicaid
Promoting Interoperability Program in 2020.
After careful consideration of the comments, we are finalizing our
proposal to amend Sec. 495.4 to provide that the EHR reporting period
in 2021 for all EPs in the Medicaid Promoting Interoperability Program
will be a minimum of any continuous 90-day period within CY 2021,
provided that the end date for this period falls before October 31,
2021, to help ensure that states can issue all Medicaid Promoting
Interoperability Program payments on or before December 31, 2021. We
are also finalizing our proposal to change the eCQM reporting period in
2021 for EPs in the Medicaid Promoting Interoperability Program to a
minimum of any continuous 90-day period within CY 2021, provided that
the end date for this period falls before October 31, 2021, to help
ensure that states can issue all Medicaid Promoting Interoperability
Program payments on or before December 31, 2021.
In addition, we are finalizing our proposal to allow states the
flexibility to set alternative, earlier final deadlines for EHR or eCQM
reporting periods for Medicaid EPs in CY 2021, with prior approval from
us, through their State Medicaid HIT Plan (SMHP). Any alternative
deadline for CY 2021 EHR and eCQM reporting periods set by a state may
not be any earlier than the day prior to the attestation deadline for
Medicaid EPs attesting to that state.
Although we did not address reporting periods in 2021 for eligible
hospitals in the proposed rule, we acknowledge that there will be a
similar issue if there are still hospitals eligible to receive Medicaid
Promoting Interoperability Program payments in 2021, including
Medicaid-only eligible hospitals as well as ``dually-eligible''
eligible hospitals and critical access hospitals (CAHs) (those that are
eligible for an incentive payment under Medicare for meaningful use of
CEHRT and/or subject to the Medicare payment reduction for failing to
demonstrate meaningful use of CEHRT, and are also eligible to earn a
Medicaid incentive payment for meaningful use of CEHRT). However, based
on attestation data and information from states' SMHPs regarding the
number of years states disburse Medicaid Promoting Interoperability
Program payments to hospitals, we believe that there will be no
hospitals eligible to receive Medicaid Promoting Interoperability
Program payments in 2021 due to the requirement that, after 2016,
eligible hospitals cannot receive a Medicaid Promoting Interoperability
Program payment unless they have received such a payment in the prior
fiscal year. At this time, we believe that there are no hospitals that
will be able to receive incentive payments in 2020 or 2021. We invited
comments and suggestions on whether this belief is accurate, and if
not, how we could address the issue in a manner that limits the burden
on hospitals and states. The following is a summary of the comments we
received on this issue.
Comment: One commenter stated that CMS's belief is accurate, and
that they

[[Page 59706]]

do not anticipate any hospitals to participate in program years 2020 or
2021. However, the commenter requested that CMS take into consideration
the audit and appeals process, which may result in payments made during
those years.
Response: We acknowledge that Medicaid Promoting Interoperability
Program incentive payments might still be made to hospitals after
hospitals' participation years, or even after December 31, 2021, in the
limited circumstance of a successful hospital appeal related to
participation in the Medicaid Promoting Interoperability Program in a
prior year.
We did not propose any specific policy regarding eligible hospital
reporting periods for 2021 in this rule and thus are not finalizing any
policy in this area now, but we expect to solicit additional comment on
the issue in a future proposed rule that is more specifically related
to hospital payment.
4. Revisions to Stage 3 Meaningful Use Measures for Medicaid EPs
a. Change to Objective 6 (Coordination of Care Through Patient
Engagement)
In the Stage 3 final rule, we adopted a phased approach under Stage
3 for EP Objective 6 (Coordination of care through patient engagement),
Measure 1 (View, Download, or Transmit) and Measure 2 (Secure
Electronic Messaging). This phased approach established a 5 percent
threshold for both measures 1 and 2 of this objective for an EHR
reporting period in 2017. (80 FR 62848 through 62849) In the same rule,
we established that the threshold for Measure 1 would rise to 10
percent, beginning with the EHR reporting period in 2018, and that the
threshold for Measure 2 would rise to 25 percent, beginning with the
EHR reporting period in 2018. We stated that we would continue to
monitor performance on these measures to determine if any further
adjustment was needed. In the FY 2018 IPPS/LTCH PPS final rule (82 FR
38493), we established a policy allowing EPs, eligible hospitals, and
CAHs to use either 2014 Edition or 2015 Edition CEHRT, or a combination
of 2014 Edition and 2015 Edition CEHRT, for an EHR reporting period in
CY 2018, and depending on which Edition(s) they use, to attest to the
Modified Stage 2 objectives and measures or the Stage 3 objectives and
measures. In doing so, we also delayed the rise of the Objective 6
Measure 1 and Measure 2 thresholds until 2019.
We explained that based on feedback we have received, we understand
that these two measures are the largest barrier to successfully
demonstrating meaningful use, especially in rural areas and at safety
net clinics. Stakeholders have reported a variety of causes that have
resulted in lower patient participation than was anticipated when the
Stage 3 final rule was issued. The data that we have collected via
states for Medicaid EPs and at CMS from Medicare EPs for previous
program years support this feedback. The primary issue is that the
view, download, transmit measure requires a positive action by
patients, which cannot be controlled by an EP. Medicaid populations
that are at the greatest risk have lower levels of internet access,
internet literacy and health literacy than the general population.
Although the Secure Electronic Messaging measure does not require
patient action, only that the EP send a secure message, we have
received feedback that this functionality is not highly utilized by
patients. Although we encourage Medicaid EPs to continue to reach out
to patients via secure messaging to engage them in their health care
between office visits, it is not productive for EPs to send messages to
patients who are unlikely to see them or take action. Retaining the
current threshold of 5 percent for both measures would continue to
incentivize Medicaid EPs to engage patients in their own care without
raising the requirements to unattainable thresholds for EPs who serve
vulnerable Medicaid patients. Therefore, we proposed to amend Sec.
495.24(d)(6)(i) such that the thresholds for Measure 1 (View, Download,
or Transmit) and Measure 2 (Secure Electronic Messaging) of Meaningful
Use Stage 3 EP Objective 6 (Coordination of care through patient
engagement) would remain 5 percent for 2019 and subsequent years.
The following is a summary of the comments we received on this
proposal.
Comment: The majority of commenters stated that they support CMS's
proposal for the Objective 6 threshold to remain at 5 percent for the
remainder of the Medicaid Promoting Interoperability Program, and that
raising the thresholds would place undue burden on EPs.
Response: We thank the many commenters who stated their support.
Comment: One commenter stated that certain populations,
specifically older adults, may struggle to engage with technology,
which created challenges for health care providers and recommended
giving special consideration to health care providers who struggle to
meet this objective.
Response: We understand that some Medicaid EPs struggle to meet the
objective due to factors outside of their control. However, this
comment further supports our decision to keep the Objective 6 threshold
at 5 percent rather than increasing it, as would happen without this
rule change.
Comment: Several commenters noted that the Medicaid Promoting
Interoperability Program and the Medicare Promoting Interoperability
category of MIPS are still not fully aligned, and that this creates
reporting burdens for providers. These commenters requested further
alignment, between these two Objective 6 measures, which were proposed
for removal under MIPS, as well as more broadly between the two
programs.
Response: We agree that alignment of MIPS and the Medicaid
Promoting Interoperability Program, to the degree practicable, is
advantageous. The greater the discrepancy between the program
requirements, the greater the reporting burden on health care providers
who participate in both programs. We are finalizing our proposed
changes to the Objective 6 measures without change, because we
anticipate that doing so will reduce Medicaid EP burden. However,
especially in light of these comments, we will also consider proposing
further changes to the Medicaid Promoting Interoperability Program in
future rulemaking, to improve alignment with the objectives and
measures under the MIPS program. In the meanwhile, we welcome input
from the public on this topic, and on additional ways that CMS can
improve alignment between the two programs.
In addition, we note that the change from the Modified Stage 2
objectives and measures will make this objective easier for Medicaid
EPs to meet. There are three measures under ``Objective 6: Coordination
of Care through Patient Engagement.'' To be a meaningful EHR user, an
EP must attest to all three measures, but only meet the thresholds for
two of those three. Under Modified Stage 2, both Measure 1 (View,
Download, or Transmit) and Measure 2 (Secure Electronic Messaging) were
required (but not under the same objective) and Measure 3 was not an
option. Both Measure 2 and Measure 3 do not rely on any patient action,
but only require Medicaid EPs' action.
After reviewing the comments, we are finalizing without change the
proposal to amend Sec. 495.24(d)(6)(i) so that the thresholds for
Measure 1 (View, Download, or Transmit) and Measure 2 (Secure
Electronic Messaging) of Meaningful Use Stage 3 EP Objective 6
(Coordination of care through patient engagement) will remain 5 percent
for 2019 and subsequent years.

[[Page 59707]]

b. Change to the Syndromic Surveillance Reporting Measure
In the proposed rule, we explained that in the Stage 3 final rule,
we established that the syndromic surveillance reporting measure for
EPs was limited to those who practice in urgent care settings (80 FR
62866 through 62870). Since then, we have received feedback from states
and public health agencies that while many are unable to accept non-
emergency or non-urgent care ambulatory syndromic surveillance data
electronically, some public health agencies can and do want to receive
data from health care providers in non-urgent care settings. We also
explained that we believe that public health agencies that set the
requirements for data submission to public health registries are in a
better position to judge which health care providers can contribute
useful data.
Therefore, we proposed to amend Sec. 495.24(d)(8)(i)(B)(2), EP
Objective 8 (Public health and clinical data registry reporting),
Measure 2 (Syndromic surveillance reporting measure), to amend the
language restricting the use of syndromic surveillance reporting for
meaningful use only to EPs practicing in an urgent care setting. We
proposed to include any EP defined by the state or local public health
agency as a provider who can submit syndromic surveillance data. This
change would not alter the exclusion for this measure at Sec.
495.24(d)(8)(i)(C)(2)(i), for EPs who are not in a category of health
care providers from which ambulatory syndromic surveillance data is
collected by their jurisdiction's syndromic surveillance system, as
defined by the state or local public health agency. Furthermore, we did
not propose to create any requirements for syndromic surveillance
registries to include all EPs. Additionally, we noted that under the
specifications for the 2015 Edition of CEHRT for syndromic
surveillance, it is possible that an EP could own CEHRT and submit
syndromic surveillance in a format that is not accepted by the local
jurisdiction. In this case, the EP may take an exclusion for syndromic
surveillance.
The following is a summary of the comments we received on this
proposal.
Comment: Several commenters stated their support of our proposal to
include any EP defined by the state or local public health agency as a
provider who can submit syndromic surveillance data.
Response: We thank the commenters for their support.
After careful consideration of the comments, we are finalizing
without change our proposal to amend Sec. 495.24(d)(8)(i)(B)(2), EP
Objective 8 (Public health and clinical data registry reporting),
Measure 2 (Syndromic surveillance reporting measure), to amend the
language restricting the use of syndromic surveillance reporting for
meaningful use only to EPs practicing in an urgent care setting. The
new objective will also include any other setting from which ambulatory
syndromic surveillance data are collected by the state or local public
health agency. This change does not alter the exclusion for this
measure at Sec. 495.24(d)(8)(i)(C)(2)(i), for EPs who are not in a
category of health care providers from which ambulatory syndromic
surveillance data is collected by their jurisdiction's syndromic
surveillance system, as defined by the state or local public health
agency. Furthermore, this does not create any requirements for
syndromic surveillance registries to include all EPs. Additionally,
under the specifications for the 2015 Edition of CEHRT for syndromic
surveillance, it is possible that an EP could own CEHRT and submit
syndromic surveillance in a format that is not accepted by the local
jurisdiction. In this case, the EP may take an exclusion for syndromic
surveillance.

F. Medicare Shared Savings Program

As required under section 1899 of the Act, we established the
Medicare Shared Savings Program (Shared Savings Program) to facilitate
coordination and cooperation among health care providers to improve the
quality of care for Medicare fee-for-service (FFS) beneficiaries and
reduce the rate of growth in expenditures under Medicare Parts A and B.
Eligible groups of providers and suppliers, including physicians,
hospitals, and other health care providers, may participate in the
Shared Savings Program by forming or participating in an Accountable
Care Organization (ACO). The final rule establishing the Shared Savings
Program appeared in the November 2, 2011 Federal Register (Medicare
Program; Medicare Shared Savings Program: Accountable Care
Organizations; Final Rule (76 FR 67802) (hereinafter referred to as the
``November 2011 final rule'')). A subsequent major update to the
program rules appeared in the June 9, 2015 Federal Register (Medicare
Program; Medicare Shared Savings Program: Accountable Care
Organizations; Final Rule (80 FR 32692) (hereinafter referred to as the
``June 2015 final rule'')). The final rule entitled, ``Medicare
Program; Medicare Shared Savings Program; Accountable Care
Organizations--Revised Benchmark Rebasing Methodology, Facilitating
Transition to Performance-Based Risk, and Administrative Finality of
Financial Calculations,'' which addressed changes related to the
program's financial benchmark methodology, appeared in the June 10,
2016 Federal Register (81 FR 37950) (hereinafter referred to as the
``June 2016 final rule'')).
In August 2018, we issued the ``Medicare Program: Medicare Shared
Savings Program; Accountable Care Organizations--Pathways to Success''
proposed rule (hereinafter referred to as the ``August 2018 proposed
rule'') which addressed a number of proposed policy changes including
redesign of the participation options available under the program to
encourage ACOs to transition to two-sided models; new tools to support
coordination of care across settings and strengthen beneficiary
engagement; revisions to ensure rigorous benchmarking; and policies
promoting use of interoperable electronic health record technology
among ACO providers/suppliers (83 FR 41786). In section V. of this
final rule, we are finalizing the following proposals from the August
2018 proposed rule:
A voluntary 6-month extension for existing ACOs whose
participation agreements expire on December 31, 2018 and the
methodology for determining financial and quality performance for this
6-month performance year from January 1, 2019, through June 30, 2019;
Policies implementing the Bipartisan Budget Act of 2018
provisions on voluntary alignment;
Modifications to the definition of primary care services
used in assigning beneficiaries to ACOs to reflect recent code changes;
Extension of policies providing relief for ACOs and their
clinicians impacted by extreme and uncontrollable circumstances during
2017 to performance year 2018 and subsequent years; and
Policies to promote interoperability among ACO providers/
suppliers, including establishing a new program eligibility requirement
regarding CEHRT use and retiring the CEHRT quality measure (ACO-11).
We expect to address the remaining proposals in the August 2018
proposed rule in a forthcoming final rule.
We have also made use of the annual calendar year (CY) PFS rules to
address quality reporting for the Shared Savings Program and certain
other issues. In the CY 2018 PFS final rule (82 FR 53209 through
53226), we finalized revisions to several different policies under the

[[Page 59708]]

Shared Savings Program, including the assignment methodology, quality
measure validation audit process, use of the skilled nursing facility
(SNF) 3-day waiver, and handling of demonstration payments for purposes
financial reconciliation and establishing historical benchmarks. In
addition, in the CY 2017 and CY 2018 Quality Payment Program final
rules (81 FR 77255 through 77260, and 82 FR 53688 through 53706,
respectively), we finalized policies related to the Alternative Payment
Model (APM) scoring standard under the Merit-Based Incentive Payment
System (MIPS), which reduces the reporting burden for MIPS eligible
clinicians who participate in MIPS APMs, such as the Shared Savings
Program, by: (1) Using the CAHPS for ACOs survey and the ACO reported
CMS Web Interface quality data for purposes of assessing quality
performance in the Shared Savings Program and to score the MIPS quality
performance category for these eligible clinicians; (2) automatically
awarding MIPS eligible clinicians participating in Shared Savings
Program ACOs a minimum of one-half of the total points in the MIPS
improvement activities performance category; (3) requiring ACO
participants to report Advancing Care Information (ACI) data at the
group practice level or solo practitioner level; and (4) not assessing
MIPS eligible clinicians on the MIPS cost performance category because,
through their participation in the ACO, they are already being assessed
on cost and utilization under the Shared Savings Program.
As a general summary, in the CY 2019 PFS proposed rule, we proposed
the following changes to the quality performance measures that will be
used to assess quality performance under the Shared Savings Program for
performance year 2019 and subsequent years:
Changes to Patient Experience of Care Survey measures.
Changes to CMS Web Interface and Claims-Based measures.
In addition, in the August 2018 proposed rule, we proposed another
change to the Shared Savings Program quality measure set, which we are
finalizing in section V.B.2.f. of this final rule. We proposed to
remove the ACO-11--Use of Certified EHR Technology measure (83 FR 41908
through 41911). We refer readers to section V.B.2.f. of this final rule
for a description of that proposal and a discussion of related public
comments.
1. Quality Measurement
a. Background
Section 1899(b)(3)(C) of the Act states that the Secretary shall
establish quality performance standards to assess the quality of care
furnished by ACOs and seek to improve the quality of care furnished by
ACOs over time by specifying higher standards, new measures, or both.
In the November 2011 final rule, we established a quality measure set
spanning four domains: Patient experience of care, care coordination/
patient safety, preventive health, and at-risk population (76 FR 67872
through 67891). Since the Shared Savings Program was established, we
have updated the measures that comprise the quality performance measure
set for the Shared Savings Program through the annual rulemaking in the
CY 2015, 2016, and 2017 PFS final rules (79 FR 67907 through 67920, 80
FR 71263 through 71268, and 81 FR 80484 through 80489, respectively).
As we stated in the November 2011 final rule establishing the
Shared Savings Program (76 FR 67872), our principal goal in selecting
quality measures for ACOs has been to identify measures of success in
the delivery of high-quality health care at the individual and
population levels, with a focus on outcomes. For performance year 2018,
31 quality measures will be used to determine ACO quality performance
(81 FR 80488 and 80489). The information used to determine ACO
performance on these quality measures will be submitted by the ACO
through the CMS Web Interface, submitted by ACO participant TINs to
MIPS for the Promoting Interoperability (PI) performance category
(formerly Advancing Care Information), calculated by CMS from
administrative claims data, and collected via a patient experience of
care survey referred to as the Consumer Assessment of Healthcare
Provider and Systems (CAHPS) for ACOs Survey. The CAHPS for ACOs survey
is based on the Clinician and Group Consumer Assessment of Healthcare
Providers and Systems (CG-CAHPS) Survey and includes additional,
program specific questions that are not part of the CG-CAHPS. The CG-
CAHPS survey is maintained, and periodically updated, by the Agency for
Healthcare Research and Quality (AHRQ) in HHS.
The quality measures collected through the CMS Web Interface in
2015 and 2016 were used to determine whether eligible professionals
participating in an ACO would avoid the PQRS and automatic Physician
Value-Based Payment Modifier (Value Modifier) downward payment
adjustments for 2017 and 2018 and to determine if ACO participants were
eligible for upward, neutral or downward adjustments based on quality
measure performance under the Value Modifier. Beginning with the 2017
performance period, which impacts payments in 2019, PQRS and the Value
Modifier were replaced by the MIPS. Eligible clinicians who are
participating in an ACO and who are subject to MIPS (MIPS eligible
clinicians) will be scored under the APM scoring standard under MIPS
(81 FR 77260). These MIPS eligible clinicians include any eligible
clinicians who are participating in an ACO in a track of the Shared
Savings Program that is not an Advanced APM, as well as those
participating in an ACO in a track that is an Advanced APM, but who do
not become Qualifying APM Participants (QPs) as specified in Sec.
414.1425, and are not otherwise excluded from MIPS. Beginning with the
2017 reporting period, measures collected through the CMS Web Interface
will be used to determine the MIPS quality performance category score
for MIPS eligible clinicians participating in a Shared Savings Program
ACO. Starting with the 2018 performance period, the quality performance
category under the MIPS APM Scoring Standard for MIPS eligible
clinicians participating in a Shared Savings Program ACO will include
measures collected through the CMS Web Interface and the CAHPS for ACOs
survey measures.
The CAHPS for ACOs Survey includes the core questions contained in
the CG-CAHPS, plus additional questions to measure access to and use of
specialist care, experience with care coordination, patient involvement
in decision-making, experiences with a health care team, health
promotion and patient education, patient functional status, and general
health. The 2018 CAHPS for ACOs Survey 3.0 incorporates updates made by
AHRQ to the CG-CAHPS survey based on feedback from survey users and
stakeholders, as well as analyses of multiple data sets. For a summary
of the history of changes to the CAHPS for ACOs survey, please refer to
the CY 2019 PFS proposed rule (83 FR 35875). Additional information on
the CG-CAHPS survey update is available on the AHRQ website at https://
www.ahrq.gov/sites/default/files/wysiwyg/cahps/surveys-guidance/cg/
about/proposed-changes-cahps-c&g-survey2015.pdf.
In addition to incorporating changes based on the AHRQ survey
update, CMS removed all items included in the

[[Page 59709]]

Summary Survey Measures (SSMs), Helping You to Take Medications as
Directed and Between Visit Communication from the 2018 survey. These
optional SSMs were not part of the scored measures. The update resulted
in a reduction in the number of survey questions from 80 to 58. The
CAHPS for ACOs SSMs that contribute to the ACO performance score for
performance year 2018, as finalized in the CY 2017 PFS final rule (81
FR 80488) are as follows: Getting Timely Care, Appointments &
Information; How Well Your Providers Communicate; Patients' Rating of
Provider; Access to Specialists; Health Promotion and Education; Shared
Decision Making; Health Status & Functional Status; and Stewardship of
Patient Resources. In addition, the core survey includes SSMs on Care
Coordination and Courteous & Helpful Office Staff. However, because
these measures are not included in the Shared Savings Program quality
measure set for 2018, scores for these measures will be provided to
ACOs for informational purposes only and will not be used in
determining the ACOs' quality scores.
b. Proposals for Changes to the CAHPS Measure Set
To enhance the Patient/Caregiver Experience domain and align with
MIPS (82 FR 54163), we proposed to begin scoring the 2 SSMs that are
currently collected with the administration of the CAHPS for ACOs
survey and shared with the ACOs for informational purposes only. Under
this proposal, we would add the following CAHPS for ACOs SSMs that are
already collected and provided to ACOs for informational purposes to
the quality measure set for the Shared Savings Program as ACO-45,
CAHPS: Courteous and Helpful Office Staff, and ACO-46: CAHPS: Care
Coordination. These measures would be scored and included in the ACO
quality determination starting in 2019. Both of these SSMs are
currently designated by AHRQ as CG CAHPS core measures.
The Courteous and Helpful Office Staff SSM, which we proposed to
add as ACO-45, asks about the helpfulness, courtesy and respectfulness
of office staff. This SSM has been a CG-CAHPS core measure in the
previous two versions of the CG-CAHPS survey, but was previously
provided for informational purposes only and not included in the ACO
quality score determination. We also proposed to add the SSM, CAHPS:
Care Coordination to the CAHPS for ACOs measures used in ACO quality
score determination as ACO-46. The Care Coordination SSM asks questions
about provider access to beneficiary information and provider follow-
up. This SSM was designated a core measure in the most recent version
of the CG-CAHPS survey.
Including these measures in the quality measure set that is used to
assess the quality performance of ACOs under the Shared Savings Program
would place greater emphasis on outcome measures and the voice of the
patient and provide ACOs with an additional incentive to act upon
opportunities for improved care coordination and communication, and
would align with the MIPS measure set finalized in the CY 2018 Quality
Payment Program final rule (82 FR 54163). Care Coordination and patient
and caregiver engagement are goals of the Shared Savings Program. The
Care Coordination SSM emphasizes the care coordination goal, while the
Courteous and Helpful Office Staff SSM supports patient engagement as
it addresses a topic that has been identified as important to
beneficiaries in testing. For performance year 2016, the mean
performance rates across all ACOs for these two measures, which were
not included in the ACO quality score determination, were 87.18 for the
Care Coordination SSM and 92.12 for Courteous and Helpful Office Staff
SSM.
Consistent with Sec. 425.502(a)(4), regarding the scoring of newly
introduced quality measures, we proposed that these additional SSMs
would be pay-for-reporting for all ACOs for 2 years (performance years
2019 and 2020). The measures would then phase into pay-for-performance
in the program, according to the schedule in Table 26 beginning in
performance year 2021. We solicited comment on this proposed change to
the quality measure set.
The following is a summary of the comments we received on this
proposed change to the CAHPS measures included in the Shared Savings
Program quality measure set.
Comment: The majority of commenters supported our proposal. Several
commenters noted that ACOs have had experience with these measures for
some time now and that patient experience measures help to keep
providers accountable for patient-centered care. A few commenters
indicated support for the proposal but noted reservations, including
the potentially limited ability of ACOs that include independent
physician groups and hospitals as ACO participants to impact
performance on ACO-45, a concern that the subjectivity of the CAHPS for
ACOs measures (especially ACO-45) may put too much emphasis on aspects
of care that have little effect on quality outcomes, and a
recommendation to consider expanding ACO-45 (Courteous and Helpful
Office Staff) to include medical assistants and nurses. Some commenters
recommended delaying implementation of the proposal. A commenter
suggested that we work with the Core Quality Measures Collaborative
(CQMC) to re-evaluate the ACO quality measures, before implementing
this proposed change. Another commenter recommended that we streamline
the Shared Savings Program quality measure set. In addition, one
commenter noted its support in principle for adding a quality measure
to assess patients' experience with office staff, but indicated that
adding a measure with a high average performance rate seems unnecessary
for improving care.
Response: We believe that adding ACO-45 CAHPS: Courteous and
Helpful Office Staff puts greater emphasis on the voice of the patient
and provides ACOs with an additional incentive to act upon
opportunities for improved communication. With regard to the comment
that ACOs that include independent physician groups and hospitals as
ACO participants may not be able to influence the outcomes of ACO-45
CAHPS: Courteous and Helpful Office Staff, we note that this SSM has
been provided for informational purposes as part of the CAHPS for ACO
survey for several years. Therefore, we believe ACOs have had
sufficient experience with the SSM and have had the opportunity to
monitor the survey results and make improvements, as needed. Scoring
this measure would also provide ACOs with a stronger incentive to
improve performance on this measure that has been identified as
important by the beneficiaries they serve. We would also re-emphasize
that measures newly added to the scored measures set will be pay-for-
reporting for the first 2 years after inclusion, giving ACOs additional
time to work toward improvement. With regard to the concern that the
proposed new CAHPS measures do not impact quality outcomes, we
disagree. We consider the patient's experience of care to be a quality
outcome. We also note that the Courteous and Helpful Office Staff
measure focuses on an issue that has been identified as important to
beneficiaries in testing and that the Care Coordination SSM addresses a
primary objective of the Shared Savings Program. With regard to
commenters' suggestions that we delay implementation of the proposal to
score these measures, including the suggestion that we work with the
CQMC

[[Page 59710]]

to re-evaluate the ACO quality measures first, we disagree with
delaying the scoring of these important SSMs. These measures assess
performance in areas that the beneficiaries served by ACOs have
identified as valuable and that are central to the fundamental purpose
of the Shared Savings Program to promote care coordination and improve
quality of care. Again, we note that the newly-scored measures would be
pay-for-reporting for the first 2 years after their addition, giving
ACOs additional time to become familiar with them before the
performance rates are considered in scoring. In response to the
commenter's suggestion that we streamline the Shared Savings Program
quality measure set, we do not have plans at this time to reduce the
number of CAHPS measures for which ACOs are held accountable. The two
CAHPs measures we proposed to add to the quality measure set for
scoring purposes are already being collected and reported to ACOs for
informational purposes; thus, the addition of these measures should not
result in significant additional burden on ACOs. Moreover, we note that
overall, we are reducing the total number of quality measures in the
ACO quality measure set, as detailed below and summarized in Table 26
of this final rule.
With regard to the comment supporting the intent of our proposal to
start scoring performance on the Courteous and Helpful Office Staff
measure, but stating that it is unnecessary to add a measure with a
high average performance rate, we believe that this is an important
area for continued measurement as beneficiaries have expressed its
importance to them in testing, as noted previously. In addition, we
believe it is important to continue monitoring this measure because it
is an important factor in patient experience of care. By scoring this
measure, we acknowledge its continued importance as a patient
experience measure. With regard to the comment that we consider
expanding ACO-45 to include medical assistants and nurses, we will take
this comment under consideration for further analysis as part of any
potential future measure refinement.
After considering the comments, we are finalizing our proposal to
begin scoring ACO-45 and ACO-46 as part of the CAHPS for ACO survey
beginning with quality reporting for performance years during 2019.
Consistent with our existing policy regarding the scoring of newly
introduced quality measures, these additional SSMs will be pay-for-
reporting for all ACOs for 2 years (performance years during 2019 and
performance year 2020). The measures would then phase into pay-for-
performance beginning in performance year 2021 (Sec. 425.502(a)(4)).
The phase-in schedule for the 2019 ACO quality measures set that we are
finalizing in this rule is presented in Table 26.
Additionally, we solicited comment on potentially converting the
Health and Functional Status SSM (ACO-7) to pay-for-performance in the
future. The Health and Functional Status SSM is currently pay-for-
reporting for all years. We have not scored this measure because the
scores on the Health and Functional Status SSM may reflect the
underlying health of beneficiaries seen by ACO providers/suppliers as
opposed to the quality of the care provided by the ACO. We also sought
stakeholder feedback on possible options for enhancing the collection
of health and functional status data, including potentially changing
our data collection procedures to collect data from the same ACO's
assigned beneficiaries over time. We noted that such a change could
allow for measurement of functional status changes that occurred while
beneficiaries were receiving care from ACO providers/suppliers. We also
solicited other recommendations regarding the potential inclusion of a
functional status measure in the assessment of ACO quality performance
in the future.
The following is a summary of the comments we received regarding
potentially converting the Health and Functional Status SSM (ACO-7) to
pay-for-performance in the future.
Comment: The majority of commenters opposed including ACO-7--Health
and Functional Status as a pay-for-performance measure in future years,
noting that the measure is largely outside of the physician's control.
Some commenters were supportive of including a Health and Functional
Status measure as pay-for-performance, but expressed concerns with
inclusion of the measure as it is currently structured. For example,
one commenter stated that the current structure of the SSM captures
patient health and functional status at a single point in time but not
as a change in status over time. A number of commenters emphasized this
point, noting that a lack of baseline data for this measure for the
ACO-assigned beneficiary population means the results cannot be
attributed to ACOs. One commenter acknowledged the potential for
collecting longitudinal data, but questioned the effectiveness of this
approach given that ACOs may not have the same beneficiaries assigned
over multiple years. Another commenter expressed concern regarding the
lack of benchmark information against which ACOs might measure their
performance to date. A commenter encouraged CMS to conduct analyses
using existing CAHPS data to identify models that allow for a fair
comparison across ACOs. Another commenter suggested an approach to
scoring health and functional status using another survey instrument
(such as Patient Reported Outcomes Measurement Information System), or
collecting baseline data for an ACO and implementing adjustments to
account for differences in patient mix across ACOs.
Response: We appreciate the comments. We agree that additional
analytic work would be needed in order to assess the potential
implications of adding a scored health and functional status measure to
the ACO quality measure set in the future. As we plan for future
updates and changes to the Shared Savings Program measure set, we will
consider this feedback from commenters further before making any
proposal to begin scoring ACO-7--Health and Functional Status or to
include a different scored heath and functional status measure.
Comment: We also received a few general comments on the
applicability of the CAHPS for ACOs SSM to institutional providers,
including a comment that raised concerns about low response rates and
low reliability of the results.
Response: We made no proposals to adjust the application of the
CAHPS for ACOs survey for any specific provider types under the Shared
Savings Program. The CAHPS for ACO survey is focused on beneficiaries'
experience of care received from clinicians in ambulatory care
settings. Consequently, we note that CMS currently excludes
beneficiaries from CAHPS sampling if 100 percent of their primary care
service visits were performed in an institutional setting (as
determined using HCPCS codes). However, after reviewing our current
CAHPS sampling process, starting with the CAHPS sample for performance
year 2018, we will also begin excluding beneficiaries if their last
primary care service visit (as determined using HCPCS codes) during the
sampling timeframe was performed in an institutional setting. We
believe this change will help to ensure that beneficiaries who are
residing in institutional settings are appropriately excluded from
CAHPS sampling. Patient experience is a key component of quality
measurement under the Shared Savings Program, and at this time we do
not have plans to provide exemptions from patient experience measures
for

[[Page 59711]]

specific ACOs. We will monitor this issue, and may in the future
consider whether additional changes to measures of patient experience
would be appropriate moving forward, based on the goals and priorities
of the Shared Savings Program.
c. Proposed Changes to the CMS Web Interface and Claims-Based Quality
Measure Sets
In developing the proposals we made in the CY 2019 PFS proposed
rule, we considered the agency's efforts to streamline quality
measures, reduce regulatory burden and promote innovation as part of
the agency's Meaningful Measures initiative (see CMS Press Release, CMS
Administrator Verma Announces New Meaningful Measures Initiative and
Addresses Regulatory Reform; Promotes Innovation at LAN Summit, October
30, 2017, available at https://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2017-Press-releases-items/2017-10-30.html). As noted in the proposed rule, under the Meaningful Measures
initiative, we have committed to assessing only those core issues that
are most vital to providing high-quality care and improving patient
outcomes, with the aim of focusing on outcome-based measures, reducing
unnecessary burden on providers, and putting patients first. In
considering the quality reporting requirements under the Shared Savings
Program, we also considered the quality reporting requirements under
other initiatives, such as the MIPS and Million Hearts Initiative, and
consulted with the measures community to ensure that the specifications
for the measures used under the Shared Savings Program are up-to-date
with current clinical guidelines, focus on outcomes over process,
reflect agency and program priorities, and reduce reporting burden.
Since the Shared Savings Program was first established in 2012, we
have updated the quality measure set to reduce reporting burden and
focus on more meaningful, outcome-based measures. The most recent
updates to the Shared Savings Program quality measure set were made in
the CY 2017 PFS final rule (81 FR 80484 through 80489) to adopt the ACO
measure recommendations made by the Core Quality Measures
Collaborative, a multi-stakeholder group with the goal of aligning
quality measures for reporting across public and private initiatives to
reduce provider reporting burden. Currently, more than half of the 31
Shared Savings Program quality measures are outcome-based, including:
Patient-reported outcome measures collected through the
CAHPS for ACOs Survey that strengthen patient and caregiver experience.
Outcome measures supporting effective communication and
care coordination, such as unplanned admission and readmission
measures.
Intermediate outcome measures that address the effective
treatment of chronic disease, such as hemoglobin A1c control for
patients with diabetes.
In the CY 2019 PFS proposed rule, we proposed to reduce the total
number of measures in the Shared Savings Program quality measure set.
The proposals were intended to reduce the burden on ACOs and their
participating providers and suppliers by lowering the number of
measures they are required to report through the CMS Web Interface and
on which they are assessed using claims data. Reducing the number of
measures on which ACOs are assessed would reduce the number of
performance metrics that they are required to track and eliminate
redundancies between measures that target similar populations. The
proposed reduction in the number of measures would enable ACOs to
better utilize their resources toward improving patient care. The
proposed reduction in the number of measures would further reduce
burden by aligning with the proposed changes to the CMS Web Interface
measures that are reported under MIPS as discussed in Tables A, C, and
D of Appendix 1: Proposed MIPS Quality Measures of the proposed rule.
We recognize that ACOs and their participating providers and suppliers
dedicate resources to performing well on our quality metrics, and we
believe that reducing the number of metrics and aligning them across
programs would allow them to more effectively target those resources
toward improving patient care. We proposed to reduce the number of
measures by minimizing measure overlap and eliminating several process
measures. The proposal to remove process measures also aligns with our
proposal to reduce the number of process measures within the MIPS
measure set as discussed in section III.H.b.iii of this final rule and
would support the CMS goal of moving toward outcome-based measurement.
We proposed to retire the following claims-based quality measures,
which have a high degree of overlap with other measures that would
remain in the measure set:
ACO-35--Skilled Nursing Facility 30-Day All-Cause
Readmission Measure (SNFRM).
ACO-36--All-Cause Unplanned Admissions for Patients with
Diabetes.
ACO-37--All-Cause Unplanned Admission for Patients with
Heart Failure.
Within the claims-based quality measures, a high degree of overlap
exists between measures with respect to the population being measured
(the denominator), because a single admission may be counted in
multiple measures. For example, ACO-35 addresses unplanned readmissions
from a SNF, and the vast majority of these SNF readmissions are also
captured in the numerator of ACO-8 Risk-Standardized All Condition
Readmission. Similarly, ACO-36 and ACO-37 address unplanned admissions
for patients with diabetes and heart failure and most of these
admissions are captured in the numerator of ACO-38 Risk-Standardized
Acute Admission Rates for Patients with Multiple Chronic Conditions
(please note that the measure name has been updated to align with
changes made by the measure steward). Therefore, to reduce redundancies
within the Shared Savings Program measure set, we proposed to remove
ACO-35, ACO-36, and ACO-37 from the measure set. However, because these
measures are claims-based measures and therefore do not impose any
reporting burden on ACOs, we intend to continue to provide information
to ACOs on their performance on these measures for use in their quality
improvement activities through a new quarterly claims-based quality
outcome report that ACOs began receiving in August 2018.
We also proposed to retire claims-based measure ACO-44--Use of
Imaging Studies for Low Back Pain, as this measure is restricted to
individuals 18-50 years of age, which results in low denominator rates
under the Shared Savings Program, meaning that the measure is not a
meaningful reflection of the beneficiaries cared for by Shared Savings
Program ACOs. Although this measure was originally added to the Shared
Savings Program quality measure set in order to align with the Core
Quality Measures Collaborative, we proposed to remove this measure as a
result of low denominators for many ACOs. We also indicated that
removing this measure would align ACO quality measurement with the MIPS
requirements as this measure was removed for purposes of reporting
under the MIPS program in the CY 2018 Quality Payment Program final
rule (82 FR 54159). However, in recognition of the value in providing
feedback to providers on potential overuse of diagnostic procedures, we
noted that we intended to continue to provide ACOs feedback on
performance on this

[[Page 59712]]

measure as part of the new quarterly claims based quality report.
We welcomed public comment on our proposal to retire these 4
claims-based measures from the quality measure set.
The following is a summary of the comments we received on our
proposal to retire ACO-35--Skilled Nursing Facility 30-Day All-Cause
Readmission Measure (SNFRM), ACO-36--All-Cause Unplanned Admissions for
Patients with Diabetes, and ACO-37--All-Cause Unplanned Admission for
Patients with Heart Failure from the quality measure set.
Comment: The majority of commenters supported our proposal to
remove these measures stating that they appreciated our efforts to
modernize the quality measurement requirements and reduce measure
overlap. However, a commenter who supported our proposal cautioned,
``that there may be a tipping point at which the choice of measures
becomes too narrowed. . . .'' Another commenter expressed concern that
diabetes is not included as one of the multiple chronic conditions for
purposes of ACO-38--All-Cause Unplanned Admissions for Patients with
Multiple Chronic Conditions (MCC). The commenter noted that the
retirement of ACO-36--All-Cause Unplanned Admissions for Patients with
Diabetes, without an adequate alternative to measure performance in
this area could cause a potential decline in provider performance and
care quality. This commenter emphasized that reducing admission rates
of diabetic patients should be a shared goal and priority of CMS and
ACOs. Another commenter asked if we considered adding diabetes as a
qualifying condition for ACO-38.
Response: We acknowledge the concerns raised by commenters with
respect to the proposed removal of ACO-36 All-Cause Unplanned
Admissions for Patients with Diabetes. However, we disagree with the
commenter who stated that without a comparable diabetes measure to
replace ACO-36 there would be a decline in provider performance and
care quality. An analysis of ACO data from the 2015 performance year
found that, as a result of the other comorbidities included for
purposes of ACO-38, 48 percent of assigned ACO beneficiaries included
in the diabetes measure were also included in the MCC measure. Measure
overlap was even higher when considering the number of unplanned
admissions shared by the two measures. Almost three-fourths (73
percent) of the unplanned admissions for assigned ACO beneficiaries
under ACO-36 were also unplanned admissions for purposes of ACO-38, and
thus were counted in both measures. In addition, we note that the
Shared Savings Program measure set still includes a diabetes measure
that monitors Hemoglobin A1c control (ACO-27: Diabetes Hemoglobin A1c
(HbA1c) Poor Control (9%)) which is reported via the CMS Web
Interface. Consequently, we believe that removing ACO-36 will not
negatively impact patients with diabetes as the majority of
readmissions for these patients are captured by ACO-38. In addition, we
note that we plan to continue providing metrics on ACO-36 and ACO-37 in
the quarterly claims-based measure reports for informational purposes
only, which will allow ACOs to continue to monitor their results for
these metrics. We are not considering revisions to add diabetes as a
qualifying condition for ACO-38 at this time, but we will consider any
changes to the ACO-38 cohort during the annual measure update. In
response to the comment that there may be a point at which the measure
set becomes too narrow, we understand the concern and will continue to
carefully consider the balance between burden reduction and meaningful
measurement in order to retain a sufficiently robust measure set
against which ACO performance can be measured.
After considering the comments, we are finalizing our proposal to
remove ACO-35--Skilled Nursing Facility 30-Day All-Cause Readmission
Measure (SNFRM), ACO-36--All-Cause Unplanned Admissions for Patients
with Diabetes, and ACO-37--All-Cause Unplanned Admission for Patients
with Heart Failure from the Shared Savings Program quality measure set
effective for quality reporting for performance years during 2019.
The following is a summary of the comments we received on our
proposal to retire ACO-44--Use of Imaging Studies for Low Back Pain
from the quality measure set.
Comment: A majority of commenters supported our proposal stating
that they agreed the measure should be removed due to low denominators
in the Medicare population and because the measure was retired from
MIPS. MedPAC opposed the removal of this measure stating, ``According
to our analysis, imaging for patients with nonspecific low back pain
affects between 3.1 to 8.9 percent of Medicare beneficiaries.'' MedPAC
encouraged CMS to consider respecifying the measure to include
beneficiaries over the age of 50 and retaining the measure in the ACO
quality measure set.
Response: We appreciate the recommendation to respecify the ACO
imaging for low-back pain measure to include beneficiaries over age 50
and recognize the value of including over-utilization of care measures
in the ACO quality measure set. However, we note that CMS is not the
measure steward for this measure. We have raised the issue with the
measure steward and will continue to coordinate with the measure owner.
Additionally, we note that we proposed to remove this measure to align
ACO quality measurement with the MIPS reporting requirements as this
measure was removed from the quality measure set under the MIPS program
in the CY 2018 Quality Payment Program final rule (82 FR 54159).
After considering the comments, we are finalizing our proposal to
remove ACO-44 from the Shared Savings Program quality measure set
effective for quality reporting for performance years during 2019.
Although we proposed to retire ACO-35 Skilled Nursing Facility 30-
Day All-Cause Readmission Measure (SNFRM) from the set of quality
measures that are scored for the Shared Savings Program, we recognize
the value of measuring the quality of care furnished to Medicare
beneficiaries in SNFs. Therefore, we solicited comment on the
possibility of adding the Skilled Nursing Facility Quality Reporting
Program (SNFQRP) measure ``Potentially Preventable 30-Day Post-
Discharge Readmission Measure for Skilled Nursing Facilities'' to the
Shared Savings Program quality measure set through future rulemaking.
This measure differs from ACO-35--SNFRM, which we are removing from the
quality measure set as discussed above, as the SNFQRP measure looks
only at unplanned, potentially preventable readmissions for Medicare
FFS beneficiaries within 30 days of discharge to a lower level of care
from a SNF, while ACO-35 assesses hospital readmissions from a SNF,
that occur within 30 days following discharge from a hospital for
beneficiaries admitted to a SNF after hospital discharge. As a result,
the SNFQRP measure would have less overlap with ACO-8 (Risk-
Standardized All Cause Readmission measure) because the readmission
windows for the two measures are different. Specifically, the
readmission window for the SNFQRP measure is 30 days following
discharge from a SNF, while the readmission window for ACO-8 is 30 days
following discharge from a hospital.
The following is a summary of the comments we received on the
possibility of adding the SNFQRP measure ``Potentially Preventable 30-
Day Post-Discharge Readmission Measure for Skilled Nursing Facilities''

[[Page 59713]]

to the Shared Savings Program quality measure set through future
rulemaking.
Comment: A few commenters supported the potential inclusion of the
SNFQRP measure to the Shared Savings Program quality measure set
through future rulemaking stating that the SNFQRP measure would
potentially add more value to the Shared Savings Program measure set
than ACO-35 as it is more targeted. Additionally, a few commenters
suggested that we should test the measure in the ACO population and
consider risk-adjusting the measure for sociodemographic factors prior
to proposing the measure for inclusion into the Shared Savings Program
quality measure set. However, the majority of commenters were opposed
to potentially adding this measure to the Shared Savings Program
quality measure set. One commenter stated that the SNFQRP measure
assumes that the ACO has input into the care processes at the SNF and
has the ability to direct patients to higher quality facilities, which
is not always the case. Another commenter stated that as the measure is
already used in the SNFQRP, they would not support inclusion in the
Shared Savings Program quality measure set because they support
avoiding the use of duplicative measures across CMS programs. Some of
the commenters further stated that they believed this measure would
still overlap with ACO-8 Risk-Standardized All Condition Readmission
measure.
Response: As we plan for future updates and changes to the Shared
Savings Program quality measure set, we will consider this feedback
prior to making any proposals regarding the SNFQRP measure.
Further, as we stated in the CY 2019 PFS proposed rule (83 FR
35877), we seek to align with changes made to the CMS Web Interface
measures under the Quality Payment Program. In the 2017 PFS final rule,
we stated that we do not believe it is beneficial to propose CMS Web
interface measures for ACO quality reporting separately (81 FR 80499).
Therefore, in order to avoid confusion and duplicative rulemaking, we
adopted a policy that any future changes to the CMS Web interface
measures would be proposed and finalized through rulemaking for the
Quality Payment Program, and that such changes would be applicable to
ACO quality reporting under the Shared Savings Program. In accordance
with the policy adopted in the CY 2017 PFS final rule (81 FR 80501), we
did not make any specific proposals related to changes in CMS Web
Interface measures reported under the Shared Savings Program. Rather,
we referred readers to Tables A, C, and D of Appendix 1: Proposed MIPS
Quality Measures in the proposed rule for a complete discussion of the
proposed changes to the CMS Web Interface measures. Based on the
changes being finalized in Tables A, C and D of Appendix 1: Finalized
MIPS Quality Measures of this final rule, ACOs will no longer be
responsible for reporting the following measures for purposes of the
Shared Savings Program starting with reporting for performance years
during 2019:
ACO-12 (NQF #0097) Medication Reconciliation Post-
Discharge.
ACO-15 (NQF #0043) Pneumonia Vaccination Status for Older
Adults.
ACO-16 (NQF #0421) Preventive Care and Screening: Body
Mass Index (BMI) Screening and Follow Up.
ACO-41 (NQF #0055) Diabetes: Eye Exam.
ACO-30 (NQF #0068) Ischemic Vascular Disease (IVD): Use of
Aspirin or another Antithrombotic.
We note that ACO-41 is one measure within a two-component diabetes
composite that is currently scored as one measure. The removal of ACO-
41 means that ACO-27 Diabetes Hemoglobin A1c (HbA1c) Poor Control
(>9%)) will now be assessed as an individual measure. As discussed in
section III.I.2.B.i of this final rule, lists of the measures being
finalized for purposes of MIPS are in Tables A, C and D of Appendix 1:
Finalized MIPS Quality Measures.
Additionally, we proposed to add the following measure to the CMS
Web Interface for purposes of the Quality Payment Program:
ACO-47 (NQF #0101) Falls: Screening, Risk-Assessment, and
Plan of Care to Prevent Future Falls.
Based on the policies being finalized for purposes of MIPS in Table
A of Appendix 1: Finalized MIPS Quality Measures, Shared Savings
Program ACOs will not be responsible for reporting this measure
starting with quality reporting for performance years during 2019.
Table 26 shows the Shared Savings Program quality measure set for
performance years during 2019 and subsequent performance years.
BILLING CODE 4120-01-P

[[Page 59714]]

[GRAPHIC] [TIFF OMITTED] TR23NO18.040

[[Page 59715]]

[GRAPHIC] [TIFF OMITTED] TR23NO18.041

BILLING CODE 4120-01-C
In this section of this final rule, we are finalizing proposals to
eliminate 9 measures and to add 2 measures to the Shared Savings
Program quality measure set. Separately, in August 2018 proposed rule,
we also proposed to remove ACO-11--Percent of Primary Care Physicians
Who Successfully Meet Meaningful Use Requirements (83 FR 41910 and
41911). We are finalizing the removal of ACO-11 in section V.B.2.f. of
this final rule and refer readers to that section for a summary of that
proposal and a discussion of public comments related to it. The net
result of the final policies included in this final rule is a set of 23
measures on which ACOs' quality performance will be assessed for
performance years during 2019 and subsequent performance years. The 4
domains will include the following numbers of quality measures (See
Table 27):
Patient/Caregiver Experience of Care--10 measures.
Care Coordination/Patient Safety--4 measures.
Preventive Health--6 measures.
At Risk Populations--3 measures.
Table 27 provides a summary of the number of measures by domain and
the total points and domain weights that will be used for scoring
purposes under the changes to the quality measure set finalized in this
rule.
[GRAPHIC] [TIFF OMITTED] TR23NO18.042

G. Physician Self-Referral Law

1. Background
Section 1877 of the Act, also known as the physician self-referral
law: (1) Prohibits a physician from making referrals for certain
designated health services (DHS) payable by Medicare to an entity with
which he or she (or an immediate family member) has a financial
relationship (ownership or compensation), unless an exception applies;
and (2) prohibits the entity from filing claims with Medicare (or
billing another individual, entity, or third party payer) for those
referred services. The statute establishes a number of specific
exceptions, and grants the Secretary the authority to create regulatory
exceptions for financial relationships that pose no risk of program or
patient abuse. Additionally, the statute mandates refunding any amount
collected under a bill for an item or service furnished under a
prohibited referral. Finally, the statute imposes reporting
requirements and provides for sanctions, including civil monetary
penalty provisions.
Section 50404 of the Bipartisan Budget Act of 2018 (Pub. L. 115-
123, enacted February 9, 2018) added provisions to section 1877(h)(1)
of the Act pertaining to the writing and

[[Page 59716]]

signature requirements in certain compensation arrangement exceptions
to the statute's referral and billing prohibitions. Although we believe
that the newly enacted provisions in section 1877(h)(1) of the Act are
principally intended merely to codify in statute existing CMS policy
and regulations with respect to compliance with the writing and
signature requirements, we proposed revisions to our regulations to
address any actual or perceived difference between the statutory and
regulatory language, to codify in regulation our longstanding policy
regarding satisfaction of the writing requirement found in many of the
exceptions to the physician self-referral law, and to make the
Bipartisan Budget Act of 2018 policies applicable to compensation
arrangement exceptions issued using the Secretary's authority in
section 1877(b)(4) of the Act.
In the CY 2016 PFS final rule with comment period (80 FR 70885), we
revised Sec. 411.357(a)(7), (b)(6), and (d)(1)(vii) to permit a lease
arrangement or personal service arrangement to continue indefinitely
beyond the stated expiration of the written documentation describing
the arrangement under certain circumstances. Section 50404 of the
Bipartisan Budget Act of 2018 added substantively identical holdover
provisions to section 1877(e) of the Act. Because the new statutory
holdover provisions effectively mirror the existing regulatory
provisions, we do not believe it is necessary to revise Sec.
411.357(a)(7), (b)(6), and (d)(1)(vii) as a result of these statutory
revisions. Therefore, we made no proposals to these provisions.
2. Special Rules on Compensation Arrangements (Section 1877(h)(1)(D) &
(E) of the Act)
Many of the exceptions for compensation arrangements in Sec.
411.357 require that the arrangements are set out in writing and signed
by the parties. (See Sec. 411.357(a)(1), (b)(1), (d)(1)(i), (e)(1)(i),
(e)(4)(i), (l)(1), (p)(2), (q) (incorporating the requirement contained
in Sec. 1001.952(f)(4)), (r)(2)(ii), (t)(1)(ii) or (t)(2)(iii) (both
incorporating the requirements contained in Sec. 411.357(e)(1)(i)),
(v)(7), (w)(7), (x)(1)(i), and (y)(1).) \9\ As described above, section
50404 of the Bipartisan Budget Act of 2018 amended section 1877 of the
Act with respect to the writing and signature requirements in the
statutory compensation arrangement exceptions. As detailed in this
section, we proposed a new special rule on compensation arrangements at
Sec. 411.354(e) and proposed to amend existing Sec. 411.353(g) to
codify the statutory provisions in our regulations.
---------------------------------------------------------------------------

\9\ We note that, where the writing requirement appears in the
statutory and regulatory exceptions, we interpret it uniformly,
regardless of any minor differences in the language of the
requirement. See 80 FR 71315. Similarly, we interpret the signature
requirement uniformly where it appears, regardless of any minor
differences in the language of the statutory and regulatory
exceptions.
---------------------------------------------------------------------------

a. Writing Requirement (Sec. 411.354(e))
In the CY 2016 PFS final rule with comment period, we stated CMS'
longstanding policy that the writing requirement in various
compensation arrangement exceptions in Sec. 411.357 can be satisfied
by ``a collection of documents, including contemporaneous documents
evidencing the course of conduct between the parties'' (80 FR 71315).
Our guidance on the writing requirement appeared in the preamble of the
CY 2016 PFS final rule with comment period but was not codified in
regulations. Section 50404 of the Bipartisan Budget Act of 2018 added
subparagraph D, ``Written Requirement Clarified,'' to section
1877(h)(1) of the Act. Section 1877(h)(1)(D) of the Act provides that,
in the case of any requirement in section 1877 of the Act for a
compensation arrangement to be in writing, such requirement shall be
satisfied by such means as determined by the Secretary, including by a
collection of documents, including contemporaneous documents evidencing
the course of conduct between the parties involved.
In light of the recently added statutory provision at section
1877(h)(1)(D) of the Act, we proposed to add a special rule on
compensation arrangements at Sec. 411.354(e). Proposed Sec.
411.354(e) provides that, in the case of any requirement in 42 CFR part
411, subpart J, for a compensation arrangement to be in writing, the
writing requirement may be satisfied by a collection of documents,
including contemporaneous documents evidencing the course of conduct
between the parties. The proposed special rule at Sec. 411.354(e)
codifies our existing policy on the writing requirement, as previously
articulated in the CY 2016 PFS final rule with comment period. (See 80
FR 71314 et seq.)
b. Special Rule for Certain Arrangements Involving Temporary
Noncompliance With Signature Requirements (Sec. 411.353(g))
Many of the exceptions for compensation arrangements in Sec.
411.357 require that the arrangement (that is, the written
documentation evidencing the arrangement) is signed by the parties to
the arrangement. Under our existing special rule for certain
arrangements involving temporary noncompliance with signature
requirements at Sec. 411.353(g)(1), an entity that has a compensation
arrangement with a physician that satisfies all the requirements of an
applicable exception in Sec. 411.355, Sec. 411.356 or Sec. 411.357
except the signature requirement may submit a claim and receive payment
for a designated health service referred by the physician, provided
that: (1) The parties obtain the required signature(s) within 90
consecutive calendar days immediately following the date on which the
compensation arrangement became noncompliant (without regard to whether
any referrals occur or compensation is paid during such 90-day period);
and (2) the compensation arrangement otherwise complies with all
criteria of the applicable exception. Existing Sec. 411.353(g)(1)
specifies the paragraphs where the applicable signature requirements
are found and existing Sec. 411.353(g)(2) limits an entity's use of
the special rule at Sec. 411.353(g)(1) to only once every 3 years with
respect to the same referring physician.
Section 50404 of the Bipartisan Budget Act of 2018 added
subparagraph E, ``Signature Requirement,'' to section 1877(h)(1) of the
Act. Section 1877(h)(1)(E) of the Act provides that, in the case of any
requirement in section 1877 of the Act for a compensation arrangement
to be in writing and signed by the parties, the signature requirement
is satisfied if: (1) Not later than 90 consecutive calendar days
immediately following the date on which the compensation arrangement
became noncompliant, the parties obtain the required signatures; and
(2) the compensation arrangement otherwise complies with all criteria
of the applicable exception. Notably, under the newly added section
1877(h)(1)(E) of the Act, an applicable signature requirement is not
limited to specific exceptions and entities are not limited in their
use of the rule to only once every 3 years with respect to the same
referring physician. In addition, section 1877(h)(1)(E) of the Act does
not include a reference to the occurrence of referrals or the payment
of compensation during the 90-day period when the signature requirement
is not met.
To conform the regulations with the recently added statutory
provision at section 1877(h)(1)(E) of the Act, we proposed to amend
existing Sec. 411.353(g) by: (1) Revising the reference at Sec.
411.353(g)(1) to specific exceptions and signature requirements; (2)
deleting the reference at Sec. 411.353(g)(1) to the

[[Page 59717]]

occurrence of referrals or the payment of compensation during the 90-
day period when the signature requirement is not met; and (3) deleting
the limitation at Sec. 411.353(g)(2). In the alternative, we proposed
to delete Sec. 411.353(g) in its entirety and codify in proposed Sec.
411.354(e) the special rule for signature requirements in section
1877(h)(1)(E) of the Act. We solicited comments regarding the best
approach for codifying in regulation this provision of the Bipartisan
Budget Act of 2018.
The following is a summary of the comments we received regarding
the best approach for codifying in regulation sections 1877(h)(1)(D) &
(E) of the Act.
Comment: We received a few comments in support of our proposal to
codify our existing policy on the writing requirement in a special rule
on compensation arrangements at Sec. 411.354(e). No commenters opposed
the proposal or suggested revisions or additions to the proposed
regulatory text in Sec. 411.354(e).
Response: We are finalizing proposed Sec. 411.354(e) without
modification. We remind readers that Sec. 411.354(e) codifies our
longstanding policy on the writing requirement in various compensation
exceptions, as explained in detail in the CY 2016 PFS final rule with
comment period. (See 80 FR 71314 et seq.)
Comment: We received a few comments expressing general support for
the special rule on temporary noncompliance with signature
requirements. Commenters appreciated the flexibility that the special
rule affords. We received no comments in opposition to our proposal.
Commenters approved of our efforts to align our regulations pertaining
to temporary noncompliance with signature requirements with the
statutory provision at section 1877(h)(1)(E) of the Act. Most
commenters did not note if it would be better to codify section
1877(h)(1)(E) of the Act at Sec. 411.353(g) or to delete Sec.
411.353(g) in its entirety and codify section 1877(h)(1)(E) of the Act
in the special rules on compensation arrangements at Sec. 411.354(e).
A couple of commenters acknowledged that both proposals provide
clarification but expressed a preference that we delete Sec.
411.353(g) in its entirety and codify section 1877(h)(1)(E) of the Act
in proposed Sec. 411.354(e), asserting that such a change would
provide a ``clear reflection of the statute.''
Response: We believe it would be less disruptive to provider and
supplier compliance efforts to amend Sec. 411.353(g), a regulation
that has been in place for over 10 years. Therefore, we are finalizing
our proposal to revise the special rule for temporary noncompliance
with signature requirements at Sec. 411.353(g), thus aligning Sec.
411.353(g) with the newly added section 1877(h)(1)(E) of the Act.
Comment: We received a few comments seeking physician self-referral
law regulatory changes that were not proposed.
Response: These comments are beyond the scope of this rulemaking
and are not addressed in this final rule.
Finally, we note that the effective date of section 50404 of the
Bipartisan Budget Act was February 9, 2018. Thus, beginning February 9,
2018, parties who meet the requirements of section 1877(h)(1)(E) of the
Act, including parties who otherwise would have been barred from
relying on the special rule for certain arrangements involving
temporary noncompliance with signature requirements at Sec.
411.353(g)(1) because of the 3-year limitation at Sec. 411.353(g)(2),
may avail themselves of the new statutory provision at section
1877(h)(1)(E) of the Act.
After reviewing the comments, we are finalizing the special rule on
compensation arrangements at Sec. 411.354(e) as proposed, and we are
finalizing the modifications to Sec. 411.353(g) as proposed.

N. Physician Self-Referral Law: Annual Update to the List of CPT/HCPCS
Codes

1. General
Section 1877 of the Act prohibits a physician from referring a
Medicare beneficiary for certain designated health services (DHS) to an
entity with which the physician (or a member of the physician's
immediate family) has a financial relationship, unless an exception
applies. Section 1877 of the Act also prohibits the DHS entity from
submitting claims to Medicare or billing the beneficiary or any other
entity for Medicare DHS that are furnished as a result of a prohibited
referral.
Section 1877(h)(6) of the Act and Sec. 411.351 of our regulations
specify that the following services are DHS:
Clinical laboratory services.
Physical therapy services.
Occupational therapy services.
Outpatient speech-language pathology services.
Radiology services.
Radiation therapy services and supplies.
Durable medical equipment and supplies.
Parenteral and enteral nutrients, equipment, and supplies.
Prosthetics, orthotics, and prosthetic devices and
supplies.
Home health services.
Outpatient prescription drugs.
Inpatient and outpatient hospital services.
2. Annual Update to the Code List
a. Background
In Sec. 411.351, we specify that the entire scope of four DHS
categories is defined in a list of CPT/HCPCS codes (the Code List),
which is updated annually to account for changes in the most recent CPT
and HCPCS Level II publications. The DHS categories defined and updated
in this manner are:
Clinical laboratory services.
Physical therapy, occupational therapy, and outpatient
speech-language pathology services.
Radiology and certain other imaging services.
Radiation therapy services and supplies.
The Code List also identifies those items and services that may
qualify for either of the following two exceptions to the physician
self-referral prohibition:
EPO and other dialysis-related drugs furnished in or by an
ESRD facility (Sec. 411.355(g)).
Preventive screening tests, immunizations, or vaccines
(Sec. 411.355(h)).
The definition of DHS at Sec. 411.351 excludes services for which
payment is made by Medicare as part of a composite rate (unless the
services are specifically identified as DHS and are themselves payable
through a composite rate, such as home health and inpatient and
outpatient hospital services). Effective January 1, 2011, EPO and
dialysis-related drugs furnished in or by an ESRD facility (except
drugs for which there are no injectable equivalents or other forms of
administration), have been reimbursed under a composite rate known as
the ESRD prospective payment system (ESRD PPS) (75 FR 49030).
Accordingly, EPO and any dialysis-related drugs that are paid for under
ESRD PPS are not DHS and are not listed among the drugs that could
qualify for the exception at Sec. [thinsp]411.355(g) for EPO and other
dialysis-related drugs furnished by an ESRD facility.
ESRD-related oral-only drugs, which are drugs or biologicals with
no injectable equivalents or other forms of administration other than
an oral form, were scheduled to be paid under ESRD PPS beginning
January 1, 2014 (75 FR 49044). However, there have been several delays
of the implementation of payment of these drugs under ESRD PPS. On
December 19, 2014, section 204 of the Stephen Beck, Jr., Achieving a
Better Life Experience Act of 2014

[[Page 59718]]

(ABLE) (Pub. L. 113-295) was enacted and delayed the inclusion of these
oral-only drugs under the ESRD PPS until 2025. Until that time, such
drugs furnished in or by an ESRD facility are not paid as part of a
composite rate and thus, are DHS.
The Code List was last updated in Tables 44 and 45 of the CY 2018
PFS final rule (82 FR 53339).
b. Response to Comments
We received no comments relating to the Code List that became
effective January 1, 2018.
c. Revisions Effective for CY 2019
The updated, comprehensive Code List effective January 1, 2019, is
available on our website at https://www.cms.gov/Medicare/Fraud-and-
Abuse/PhysicianSelfReferral/List_of_Codes.html.
Additions and deletions to the Code List conform it to the most
recent publications of CPT and HCPCS Level II and to changes in
Medicare coverage policy and payment status.
Tables 28 and 29 identify the additions and deletions,
respectively, to the comprehensive Code List that become effective
January 1, 2019. Tables 28 and 29 also identify the additions and
deletions to the list of codes used to identify the items and services
that may qualify for the exception in Sec. 411.355(g) (regarding
dialysis-related outpatient prescription drugs furnished in or by an
ESRD facility) and in Sec. 411.355(h) (regarding preventive screening
tests, immunizations, and vaccines).

Table 28--Additions to the Physician Self-Referral List of CPT \1\ HCPCS
Codes
------------------------------------------------------------------------

-------------------------------------------------------------------------
Clinical Laboratory Services:
0018U Onc thyr 10 microrna seq alg.
0019U Onc rna tiss predict alg.
0020U Rx test prsmv ur w/def conf.
0021U Onc prst8 detcj 8 autoantb.
0022U Trgt gen seq dna&rna 23 gene.
0023U Onc aml dna detcj/nondetcj.
0024U Glyca nuc mr spectrsc quan.
0025U Tenofovir liq chrom ur quan.
0026U Onc thyr dna&mrna 112 genes.
0027U Jak2 gene trgt seq alys.
0028U Cyp2d6 gene cpy nmr cmn vrnt.
0029U Rx metab advrs trgt seq alys.
0030U Rx metab warf trgt seq alys.
0031U Cypia2 gene.
0032U Comt gene.
0033U Htr2a htr2c genes.
0034U Tpmt nudt15 genes.
0035U Neuro csf prion prtn qual.
0036U Xome tum & nml spec seq alys.
0037U Trgt gen seq rgt gen seq dna 324 genes.
0038U Vitamin d srm microsamp quan.
0039U Dna antb 2strand hi avidity.
0040U Bcr/abl1 gene major bp quan.
0041U B brgdrferi antb 5 prtn igm.
0042U B brgdrferi antb 12 prtn igg.
0043U Tbrg b grp antb 4 prtn igm.
0044U Tbrf b grp antb 4 prtn igg.
0045U Onc brst dux carc is 12 gene.
0046U Flt3 genie itd variants quan.
0047U Onc prst8 mrna 17 gene alg.
0048U Onc sld org neo dna 468 gene.
0049U Npm1 gene analysis quan.
0050U Trgt gen seq dna 194 genes.
0051U Rx mntr lc-ms/ms ur 31 pnl.
0052U Lpoprtn bld w/5 maj classes.
0053U Onc prst8 ca fish alys 4 gen.
0054U Rx mntr 14+ drugs & sbsts.
0055U Card hrt trnspl 96 dna seq.
0056U Hem aml dna gene reargmt.
0057U Onc sld org neo mrna 51 gene.
0058U Onc merkel cll carc srm quan.
0059U Onc merkel cll carc srm+/-.
0060U Twn zyg gen seq alys chrms2.
0061U Tc meas 5 bmrk sfdi m-s alys.
0011M Onc prst8 ca mrna 12 gen alg.
0012M Onc mrna 5 gen rsk urthl ca.
0013M Onc mrna 5 gen recr urthl ca.
Physical Therapy, Occupational Therapy, and Outpatient Speech-Language
Pathology Services:
{No additions.{time}
Radiology and Certain Other Imaging Services:
0508T Pls echo us b1 dns meas tib.
76391 Mr elastography.
76978 Us trgt dyn mbubb 1st les.
76979 Us trgt dyn mbubb ea addl.
76981 Use parenchyma.
76982 Use 1st target lesion.
76983 Use ea addl target lesion.
77046 Mri breast c-unilateral.
77047 Mri breast c-bilateral.
77048 Mri breast c-+ w/cad uni.
77049 Mri breast c-+ w/cad bi.
C8937 Cad breast Mri.
C9407 Iodine i-131 iobenguane, dx.
Q9950 Inj sulf hexa lipid microsph.
Radiation Therapy Services and Supplies:
A9513 Lutetium Lu 177 dotatat ther.
C9408 Iodine i-131 iobenguane, tx.
Drugs Used by Patients Undergoing Dialysis:
{No additions.{time}
Preventive Screening Tests, Immunizations and Vaccines:
81528 Oncology colorectal scr.
90689 Vacc IIv4 no prsrv 0.25ml im.
------------------------------------------------------------------------
\1\ CPT codes and descriptions only are copyright 2018 AMA. All rights
are reserved and applicable FARS/DFARS clauses apply.

Table 29--Deletions From the Physician Self-Referral List of CPT \1\
HCPCS Codes
------------------------------------------------------------------------

-------------------------------------------------------------------------
Clinical Laboratory Services:
78270 Vit B-12 absorption exam.
78271 Vit B-12 absrp exam int fac.
78272 Vit B-12 absorp combined.
Physical Therapy, Occupational Therapy, and Outpatient Speech-Language
Pathology Services:
64550 Appl surface neurostimulator.
96111 Developmental testing.
Radiology and Certain Other Imaging Services:
0159T Cad breast mri.
0346T Ultrasound elastography.
C9744 Abd us w/contrast.
77058 Mri one breast.
77059 Mri both breasts.
77776 Apply interstit radiat simpl.
77785 HDR brachytx 1 channel.
77786 HDR brachytx 2-12 channel.
C9457 Lumason contrast agent.
C9461 Choline C 11, diagnostic.
G0173 Linear acc stereo radsur com.
G0251 Linear acc based stero radio.
Radiation Therapy Services and Supplies:
0190T Place intraoc radiation src.
Drugs Used by Patients Undergoing Dialysis:
{No deletions{time} .
Preventive Screening Tests, Immunizations and Vaccines:
G0389 Ultrasound exam AAA screen.
G0464 Colorec CA scr, sto bas DNA.
------------------------------------------------------------------------
\1\ CPT codes and descriptions only are copyright 2018 AMA. All rights
are reserved and applicable FARS/DFARS clauses apply.

I. CY 2019 Updates to the Quality Payment Program

1. Executive Summary
a. Overview
This final rule will make payment and policy changes to the Quality
Payment Program starting January 1, 2019, except as noted for specific
provisions elsewhere in this final rule. The Medicare Access and CHIP
Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10, enacted April 16,
2015) amended title XVIII of the Act to repeal the Medicare sustainable
growth rate (SGR) formula, to reauthorize the Children's Health
Insurance Program, and to strengthen Medicare access by improving
physician and other clinician payments and making other improvements.
The MACRA advances a forward-looking, coordinated framework for
clinicians to successfully participate in the Quality Payment Program,
which rewards value in one of two ways:
The Merit-based Incentive Payment System (MIPS).
Advanced Alternative Payment Models (Advanced APMs).
As we move into the third year of the Quality Payment Program, we
have taken all stakeholder input into consideration, including
recommendations made by the Medicare Payment Advisory Commission
(MedPAC), an independent congressional agency established by the
Balanced Budget Act of 1997 (Pub. L. 105-33, enacted on August 5, 1997)
to advise the U.S. Congress on issues

[[Page 59719]]

affecting the Medicare program, such as payment policies under
Medicare, the factors affecting expenditures for the efficient
provision of services, and the relationship of payment policies to
access and quality of care for Medicare beneficiaries. We will continue
to implement the Quality Payment Program as required, smoothing the
transition where possible and offering targeted educational resources
for program participants. A few examples of how we are working to
address stakeholder input are evident in our work around burden
reduction and reshaping our focus of interoperability. We have heard
the concern about process-based measures, and we are continuing to move
towards the development and use of more outcome measures by way of
removing process measures that are topped out and funding new quality
measure development, as required by section 102 of MACRA. We have also
developed new episode-based cost measures, with stakeholder feedback,
for inclusion in the cost performance category beginning in 2019, with
additional measure development occurring for potential inclusion in
future years.
Additionally, we have also received feedback from stakeholders
regarding the added value of the Quality Payment Program. To that
point, CMS has begun a series of strategic planning sessions to (1)
assess the current value of the program for clinicians and
beneficiaries alike and (2) implement the program in a way that is
understandable to beneficiaries, as they are the core of the Medicare
program.
As a priority for the Quality Payment Program Year 3, we are
committed to continue using the framework established by the Patients
over Paperwork initiative to assist in reducing clinician burden,
implementing the Meaningful Measures Initiative, promoting
interoperability, continuing our support of small and rural practices,
empowering patients, and promoting price transparency.
Reducing Clinician Burden
We are committed to reducing clinician burden by simplifying and
streamlining the program for participating clinicians. Examples
include:
Implementing the Meaningful Measures Initiative, which is
a framework that applies a series of cross-cutting criteria to identify
and utilize the most meaningful measures with the least amount of
burden and greatest impact on patient outcomes;
Promoting advances in interoperability; and
Establishing an automatic extreme and uncontrollable
circumstances policy for MIPS eligible clinicians.
Improving Patient Outcomes and Reducing Burden Through Meaningful
Measures
Regulatory reform and reducing regulatory burden are high
priorities for CMS. To reduce the regulatory burden on the healthcare
industry, lower health care costs, and enhance patient care, we
launched the Meaningful Measures Initiative in October 2017.\10\ This
initiative is one component of our agency-wide Patients Over Paperwork
Initiative,\11\ which is aimed at evaluating and streamlining
regulations with a goal to reduce unnecessary cost and burden, increase
efficiencies, and improve beneficiary experience. The Meaningful
Measures Initiative is aimed at identifying the highest priority areas
for quality measurement and quality improvement to assess the core
quality of care issues that are most vital to advancing our work to
improve patient outcomes. The Meaningful Measures Initiative represents
a new approach to quality measures that fosters operational
efficiencies, and reduces cost associated with collection and reporting
burden, while producing quality measurement that is more focused on
meaningful outcomes.
---------------------------------------------------------------------------

\10\ Meaningful Measures web page: https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-Assessment-Instruments/
QualityInitiativesGenInfo/MMF/General-info-Sub-Page.html.
\11\ See Remarks by Administrator Seema Verma at the Health Care
Payment Learning and Action Network (LAN) Fall Summit, as prepared
for delivery on October 30, 2017, https://www.cms.gov/Newsroom/
MediaReleaseDatabase/Fact-sheets/2017-Fact-Sheet-items/2017-10-
30.html.
---------------------------------------------------------------------------

The Meaningful Measures Framework has the following principles for
identifying measures that:
Address high-impact measure areas that safeguard public
health;
Patient-centered and meaningful to patients;
Outcome-based where possible;
Fulfill each program's statutory requirements;
Minimize the level of burden for health care providers
(for example, through a preference for EHR-based measures where
possible, such as electronic clinical quality measures);
Significant opportunity for improvement;
Address measure needs for population based payment through
alternative payment models; and
Align across programs and/or with other payers.
To achieve these objectives, we have identified 19 Meaningful
Measures areas and mapped them to six overarching quality priorities as
shown in Table 30.

Table 30--Meaningful Measures Framework Domains and Measure Areas
------------------------------------------------------------------------
Quality priority Meaningful measure area
------------------------------------------------------------------------
Making Care Safer by Reducing Harm Healthcare-Associated
Caused in the Delivery of Care. Infections.
Preventable Healthcare Harm.
Strengthen Person and Family Engagement Care is Personalized and
as Partners in Their Care. Aligned with Patient's Goals.
End of Life Care according to
Preferences.
Patient's Experience of Care.
Patient Reported Functional
Outcomes.
Promote Effective Communication and Medication Management.
Coordination of Care. Admissions and Readmissions to
Hospitals.
Transfer of Health Information
and Interoperability.
Promote Effective Prevention and Preventive Care.
Treatment of Chronic Disease. Management of Chronic
Conditions.
Prevention, Treatment, and
Management of Mental Health.
Prevention and Treatment of
Opioid and Substance Use
Disorders.
Risk Adjusted Mortality.
Work with Communities to Promote Best Equity of Care.
Practices of Healthy Living. Community Engagement.

[[Page 59720]]

Make Care Affordable................... Appropriate Use of Healthcare.
Patient-focused Episode of
Care.
Risk Adjusted Total Cost of
Care.
------------------------------------------------------------------------

By including Meaningful Measures in our programs, we believe that
we can also address the following cross-cutting measure criteria:
Eliminating disparities;
Tracking measurable outcomes and impact;
Safeguarding public health;
Achieving cost savings;
Improving access for rural communities; and
Reducing burden.
We believe that the Meaningful Measures Initiative will improve
outcomes for patients, their families, and health care providers while
reducing burden and costs for clinicians and providers and promoting
operational efficiencies.
In the quality performance category under MIPS, clinicians have the
flexibility to select and report the measures that matter most to their
practice and patients. However, we have received feedback that some
clinicians find the performance requirements confusing, and the program
makes it difficult for them to choose measures that are meaningful to
their practices and have more direct benefit to beneficiaries. For the
2019 MIPS performance period, we are finalizing the following updates:
(1) Adding 8 new MIPS quality measures that include 4 patient reported
outcome measures, 6 high priority measures, and 2 measures on important
clinical topics in the Meaningful Measures framework; and (2) removing
26 quality measures.
In addition to having the right measures, we want to ensure that
the collection of information is valuable to clinicians and worth the
cost and resources of collecting the information.
Promoting Interoperability Performance Category
As required by MACRA, the Quality Payment Program includes a MIPS
performance category that focuses on meaningful use of certified EHR
technology, referred to in the CY 2017 and CY 2018 Quality Payment
Program final rules as the ``advancing care information'' performance
category. As part of our approach to promoting and prioritizing
interoperability of healthcare data, in Quality Payment Program Year 2,
we changed the name of the performance category to the Promoting
Interoperability performance category.
We have prioritized interoperability, which we define as health
information technology, that enables the secure exchange of electronic
health information with, and use of electronic health information from,
other health information technology without special effort on the part
of the user; allows for complete access, exchange, and use of all
electronically accessible health information for authorized use under
applicable law; and does not constitute information blocking as defined
by the 21st Century Cures Act (Pub. L. 114-255, enacted December 13,
2016). We are committed to working with the Office of the National
Coordinator for Health IT (ONC) on implementation of the
interoperability provisions of the 21st Century Cures Act to have
seamless but secure exchange of health information for clinicians and
patients, ultimately enabling Medicare beneficiaries to get their
claims information electronically. In addition, we are prioritizing
quality measures and improvement activities that support
interoperability.
To further CMS' commitment to implementing interoperability, at the
2018 Healthcare Information and Management Systems Society (HIMSS)
conference, CMS Administrator Seema Verma announced the launching of
the MyHealthEData initiative.\12\ This initiative aims to empower
patients by ensuring that they control their healthcare data and can
decide how their data is going to be used, all while keeping that
information safe and secure. The overall government-wide initiative is
led by the White House Office of American Innovation with participation
from HHS--including its CMS, ONC, and the National Institutes of Health
(NIH)--as well as the U.S. Department of Veterans Affairs (VA).
MyHealthEData aims to break down the barriers that prevent patients
from having electronic access and true control of their own health
records from the device or application of their choice. This effort
will approach the issue of healthcare data from the patient's
perspective.
---------------------------------------------------------------------------

\12\ https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-
sheets/2018-Fact-sheets-items/2018-03-06.html.
---------------------------------------------------------------------------

For the Promoting Interoperability performance category, we require
MIPS eligible clinicians to use 2015 Edition certified EHR technology
beginning with the 2019 MIPS performance period to make it easier for:
Patients to access their data.
Patient information to be shared between doctors and other
health care providers.
Continuing To Support Small and Rural Practices
We understand that the Quality Payment Program is a big change for
clinicians, especially for those in small and rural practices. We
intend to continue to offer tailored flexibilities to help these
clinicians to participate in the program. For example, in this rule we
are finalizing our proposal to retain a small practice bonus under MIPS
by moving it to the quality performance category. We will also continue
to support small and rural practices by offering free and customized
resources available within local communities, including direct, one-on-
one support from the Small, Underserved, and Rural Support Initiative
along with our other no-cost technical assistance.
Further, we note that we are finalizing our proposal to amend our
regulatory text to allow small practices to continue using the Medicare
Part B claims collection type. We are also finalizing our proposal to
revise the regulatory text to allow a small practice to submit quality
data for covered professional services through the Medicare Part B
claims submission type for the quality performance category, as
discussed further in section III.I.3.h. of this final rule. Finally, in
the CY 2018 Quality Payment Program final rule, we finalized a policy
to allow small practices to continue to choose to participate in MIPS
as a virtual group (82 FR 53598).
Empowering Patients Through the Patients Over Paperwork Initiative
Our Patients Over Paperwork initiative establishes an internal
process to evaluate and streamline regulations with a goal to reduce
unnecessary burden, to increase efficiencies, and to

[[Page 59721]]

improve the beneficiary experience.\13\ This administration is
dedicated to putting patients first, empowering consumers of healthcare
to have the information they need to be engaged and active decision-
makers in their care. As a result of this consumer empowerment,
clinicians will gain competitive advantage by delivering coordinated,
high-value quality care.
---------------------------------------------------------------------------

\13\ Patients Over Paperwork web page available at https://
www.cms.gov/Outreach-and-Education/Outreach/Partnerships/
PatientsOverPaperwork.html.
---------------------------------------------------------------------------

The policies for the Quality Payment Program in this final rule
promote competition and empower patients. We are consistently
listening, and we are committed to using data-driven insights,
increasingly aligned and meaningful quality measures, and technology
that empowers patients and clinicians to make decisions about their
healthcare.
In conjunction with development of the Patients Over Paperwork
initiative, we are making progress toward developing a patient-centered
portfolio of measures for the Quality Payment Program, including 7 new
outcome measures included on the 2017 CMS Measures Under Consideration
List,\14\ 5 of which are directly applicable to the prioritized
specialties of general medicine/crosscutting and orthopedic surgery.
Finally, on September 21, 2018, CMS awarded seven organizations new
cooperative agreements to partner with the agency in developing,
improving, updating, or expanding quality measures for Medicare's
Quality Payment Program. Awardees will work to establish more
appropriate measures for clinical specialties underrepresented in the
current measure set with the goal of improving patient care, and focus
on outcome measures, including patient-reported and functional-status
measures, to better reflect what matters most to patients.\15\
---------------------------------------------------------------------------

\14\ Centers for Medicare & Medicaid Services. List of Measures
Under Consideration for December 1, 2017. Baltimore, MD: US
Department of Health and Human Services; 2017. https://www.cms.gov/
Medicare/Quality-Initiatives-Patient-Assessment-Instruments/
QualityMeasures/Downloads/Measures-under-Consideration-
Listfor2017.pdf. Accessed May 4, 2018.
\15\ CMS Awards Funding for Quality Measure Development, https:/
/www.cms.gov/newsroom/press-releases/cms-awards-funding-quality-
measure-development.
---------------------------------------------------------------------------

b. Summary of the Major Provisions
In May 2018, CMS announced that 91 percent of MIPS eligible
clinicians participated in the 2017 transition year. (See https://
www.cms.gov/blog/quality-payment-program-exceeds-year-1-participation-
goal.) This CY 2017 performance period data were incorporated for this
final rule when estimating eligibility and payment adjustment for the
CY 2019 MIPS performance period. One important finding is that many
more clinicians than reported in the CY 2019 PFS proposed rule are
expected to participate in MIPS using the group reporting option. This
increase means more clinicians are covered in MIPS and are measured on
their performance.
(1) Quality Payment Program Year 3
During the first 2 years of the program, we have heard concerns
from clinicians that were not eligible to participate. Under MIPS, for
year 3, we are expanding in this final rule the opportunities to
participate, while still understanding the burden required to
participate, to include physical therapists, occupational therapists,
qualified speech-language pathologists, qualified audiologists,
clinical psychologists, and registered dietitians or nutrition
professionals in the list of MIPS eligible clinicians. We also are
finalizing an opt-in policy that allows some clinicians, who otherwise
would have been excluded under the low-volume threshold, the option to
participate in MIPS.
We believe the third year of the Quality Payment Program should
build upon the foundation that has been established in the first 2
years, which provides a trajectory for clinicians moving to a
performance-based payment system. This trajectory provides clinicians
the ability to participate in the program through two pathways: MIPS
and Advanced APMs.
(2) Payment Adjustments
As discussed in section VII.F.8. of this final rule, for the 2021
payment year and based on Advanced APM participation during the 2019
MIPS performance period, we estimate that between 165,000 and 220,000
clinicians will become Qualifying APM Participants (QP). As a QP, an
eligible clinician is not subject to the MIPS reporting requirements
and payment adjustment, and qualifies for a lump sum APM incentive
payment equal to 5 percent of their aggregate payment amounts for
covered professional services for the year prior to the payment year.
We estimate that the total lump sum APM incentive payments will be
approximately $600-800 million for the 2021 Quality Payment Program
payment year.
Again, we estimate that approximately 798,000 clinicians would be
MIPS eligible clinicians in the 2019 MIPS performance period, an
increase of almost 148,000 from the estimate we provided in the CY 2019
PFS proposed rule, which reflects growth in group reporting and our
ability to better capture group reporting. The final number will depend
on several factors, including the number of eligible clinicians
excluded from MIPS based on their status as QPs or Partial QPs, the
number that report as groups, and the number that elect to opt-in to
MIPS. In the 2021 MIPS payment year, MIPS payment adjustments, which
only apply to covered professional services, will be applied based on
MIPS eligible clinicians' performance on specified measures and
activities within four integrated performance categories. We estimate
that MIPS payment adjustments will be approximately equally distributed
between negative MIPS payment adjustments ($390 million) and positive
MIPS payment adjustments ($390 million) to MIPS eligible clinicians, as
required by the statute to ensure budget neutrality. Positive MIPS
payment adjustments will also include up to an additional $500 million
for exceptional performance to MIPS eligible clinicians whose final
score meets or exceeds the additional performance threshold of 75
points that we are establishing in this final rule. However, the
distribution will change based on the final population of MIPS eligible
clinicians for the 2021 MIPS payment year and the distribution of final
scores under the program.
2. Definitions
At Sec. 414.1305, subpart O--
We are revising in this final rule the regulation to
define the following terms:
++ Ambulatory Surgical Center (ASC)-based MIPS eligible clinician.
++ Collection type.
++ Health IT vendor.
++ MIPS determination period.
++ Submission type.
++ Submitter type.
++ Third party intermediary.
We are revising in this final rule the definitions of the
following terms:
++ High priority measure.
++ Hospital-based MIPS eligible clinician
++ Low-volume threshold.
++ MIPS eligible clinician.
++ Non-patient facing MIPS eligible clinician.
++ Qualified clinical data registry (QCDR).
++ Qualifying APM Participant (QP).
++ Small practice.

These terms and definitions are discussed in detail in relevant
sections of this final rule.

[[Page 59722]]

3. MIPS Program Details
a. MIPS Eligible Clinicians
Under Sec. 414.1305, a MIPS eligible clinician, as identified by a
unique billing TIN and NPI combination used to assess performance, is
defined as any of the following (excluding those identified at Sec.
414.1310(b)): A physician (as defined in section 1861(r) of the Act); a
physician assistant, nurse practitioner, and clinical nurse specialist
(as such terms are defined in section 1861(aa)(5) of the Act); a
certified registered nurse anesthetist (as defined in section
1861(bb)(2) of the Act); and a group that includes such clinicians.
Section 1848(q)(1)(C)(II) of the Act provides the Secretary with
discretion, beginning with the 2021 MIPS payment year, to specify
additional eligible clinicians (as defined in section 1848(k)(3)(B) of
the Act) as MIPS eligible clinicians. Such clinicians may include
physical therapists, occupational therapists, or qualified speech-
language pathologists; qualified audiologists (as defined in section
1861(ll)(3)(B) of the Act); certified nurse-midwives (as defined in
section 1861(gg)(2) of the Act); clinical social workers (as defined in
section 1861(hh)(1) of the Act); clinical psychologists (as defined by
the Secretary for purposes of section 1861(ii) of the Act); and
registered dietitians or nutrition professionals.
As discussed in the CY 2019 PFS proposed rule (83 FR 35883 through
35884), we received feedback from non-physician associations
representing each type of additional eligible clinician through
listening sessions and meetings with various stakeholder entities and
through public comments discussed in the CY 2017 Quality Payment
Program final rule (81 FR 77038). Commenters generally supported the
specification of such clinicians as MIPS eligible clinicians beginning
with the 2021 MIPS payment year. In order to assess whether these
additional eligible clinicians could successfully participate in MIPS,
we evaluated whether there would be sufficient measures and activities
applicable and available for each of the additional eligible clinician
types. We finalized in the CY 2018 Quality Payment Program final rule
(82 FR 53780), that having sufficient measures for the quality
performance category, means having sufficient measures applicable and
available means that we can calculate a quality performance category
percent score for the MIPS eligible clinician because at least one
quality measure is applicable and available to the clinician. For the
improvement activities performance category, we stated the belief that
all MIPS eligible clinicians will have sufficient activities applicable
and available. We focused our analysis on the quality and improvement
activities performance categories because these performance categories
require submission of data. We did not focus on the Promoting
Interoperability performance category because there is extensive
analysis regarding who can participate in the Promoting
Interoperability performance category under the current exclusion
criteria. In addition, in section III.I.3.h.(5) of this final rule, we
are finalizing a policy to automatically assign a zero percent
weighting for the Promoting Interoperability performance category for
these new types of MIPS eligible clinicians. We did not focus as part
of our analysis on the cost performance category because we are only
able to assess cost performance for a subset of eligible clinicians--
specifically, those who are currently eligible as a result of not
meeting any of the current exclusion criteria. So the impact of the
cost performance category for these additional eligible clinicians will
continue to be considered but is currently not a decisive factor for
successful participation in MIPS. From our analysis, we found that
improvement activities would generally be applicable and available for
each of the additional eligible clinician types. However, for the
quality performance category, we found that not all of the additional
eligible clinician types would have sufficient MIPS quality measures
applicable and available. As discussed in section III.I.3.h.(2)(b)(iii)
of this final rule, for the quality performance category, we are
finalizing our proposals to remove several MIPS quality measures. In
the CY 2019 PFS proposed rule (83 FR 35883 through 35884), we explained
that if those measures were finalized for removal, we anticipated that
qualified speech-language pathologists, qualified audiologists,
certified nurse-midwives, and registered dietitians or nutrition
professionals would each have less than 6 MIPS quality measures
applicable and available to them. However, if the quality measures were
not finalized for removal, we would reassess whether these eligible
clinicians would have an adequate amount of MIPS quality measures
available to them. We proposed to include these additional clinicians
in the MIPS eligible clinician definition if we found that they do have
at least 6 MIPS quality measures available to them. As discussed in
``Appendix 1: Finalized MIPS Quality Measures'', TABLE Group C. of this
final rule, we are retaining one of the MIPS quality measures that was
proposed for removal: ``Colonoscopy Interval for Patients with a
History of Adenomatous Polyps--Avoidance of Inappropriate Use''
(Quality #185). We do not believe that this measure is applicable to
any of the proposed additional eligible clinicians. Therefore, it does
not affect the number of available measures for these clinicians. We
refer readers to section III.I.3.h.(2) of this final rule for more
information regarding quality measures.
We focused on the quality performance category because the quality
and improvement activities performance categories require submission of
data. We believed there would generally be applicable and available
improvement activities for each of the additional eligible clinician
types, but that not all of the additional eligible clinician types
would have sufficient MIPS quality measures applicable and available if
the proposed MIPS quality measures were removed from the program. In
our analysis, we did find QCDR measures approved for the CY 2018
performance period that are either high priority and/or outcome
measures that, if approved for the CY 2019 performance period, may be
applicable to these additional eligible clinicians. However, this would
necessitate that the clinician utilize a QCDR in order to be successful
in MIPS. Further, we have heard some concerns from the non-physician
associations, through written correspondence, that since their
clinicians would be joining the program 2 years after its inception, we
should consider several ramp-up policies in order to facilitate an
efficient integration of these clinicians into MIPS. We note that the
MIPS program is still ramping up, and we will continue to increase the
performance threshold to ensure a gradual and incremental transition to
the performance threshold that will be used in the Quality Payment
Program Year 6. Therefore, if specified as MIPS eligible clinicians
beginning with the 2021 MIPS payment year, the additional eligible
clinicians would have 4 years in the program in order to ramp up.
Conversely, if specified as MIPS eligible clinicians beginning in a
future year, they would be afforded less time to ramp up the closer the
program gets to Quality Payment Program Year 6.
We requested comments on our proposal to amend Sec. 414.1305 to
modify the definition of a MIPS eligible clinician, as identified by a
unique billing TIN and NPI combination used to assess performance, to
mean any of

[[Page 59723]]

the following (excluding those identified at Sec. 414.1310(b)): A
physician (as defined in section 1861(r) of the Act); a physician
assistant, nurse practitioner, and clinical nurse specialist (as such
terms are defined in section 1861(aa)(5) of the Act); a certified
registered nurse anesthetist (as defined in section 1861(bb)(2) of the
Act); beginning with the 2021 MIPS payment year, a physical therapist,
occupational therapist, a clinical social worker (as defined in section
1861(hh)(1) of the Act), a clinical psychologist (as defined by the
Secretary for purposes of section 1861(ii) of the Act); and a group
that includes such clinicians. Alternatively, we proposed that if the
quality measures proposed for removal were not finalized, then we would
include additional eligible clinician types in the definition of a MIPS
eligible clinician beginning with the 2021 MIPS payment year
(specifically, qualified speech-language pathologists, qualified
audiologists, certified nurse-midwives, and registered dietitians or
nutrition professionals), provided that we determine that each
applicable eligible clinician type would have at least 6 MIPS quality
measures available to them. In addition, we requested comments on: (1)
Specifying qualified speech-language pathologists, qualified
audiologists, certified nurse-midwives, and registered dietitians or
nutrition professionals as MIPS eligible clinicians beginning with the
2021 MIPS payment year; and (2) delaying the specification of one or
more additional eligible clinician types as MIPS eligible clinicians
until a future MIPS payment year.
The following is a summary of the public comments received on our
proposals and our responses:
Comment: Many commenters supported our proposal to expand the
definition of MIPS eligible clinicians to physical therapists,
occupational therapists, clinical social workers, and clinical
psychologists. A few commenters encouraged us to ensure that a
reasonable number of measures are maintained for these newly eligible
clinicians. Other commenters specifically discussed adding qualified
audiologist and qualified speech-language pathologists as MIPS eligible
clinicians, stating that there are enough discipline-specific measures
for these clinicians to be included in the program. One commenter
specifically stated that registered dietitians have seven quality
measures on which to report, and, therefore should be included in the
program. A few commenters requested that we include the following
additional clinicians as MIPS eligible clinicians: Nurse navigators,
oncology staff nurses, and clinical pharmacists, stating that adding
more clinicians would enable better understanding of healthcare data
across other specialties.
Response: We appreciate the additional information provided
regarding the quality measures available to the additional eligible
clinicians. After review of the additional information regarding
quality measures we revisited our findings and found support for the
comments. We were persuaded by the arguments of the specialties who
requested to be included in the program including: Physical therapists,
occupational therapists, speech-language pathologists, audiologists,
clinical psychologists, and dieticians or nutrition professionals.
However, we believe that clinical social workers may not have six
applicable quality measures to report. For example, some measures may
contain CPT codes utilized by clinical social workers, but may not be
applicable to their practice. We do believe that there is at least one
quality measure that clinical social workers could report for MIPS. We
encourage the clinicians within the specialty provide feedback during
the specialty measure set solicitation process to create a measure set
applicable to clinical social workers for implementation in future
rulemaking. This will ensure proper scoring based on applicable
measures and will not hold clinical social workers accountable for
measures that are outside their scope. Therefore, we are modifying our
proposal by removing clinical social workers from our proposed list and
including qualified speech-language pathologists, qualified
audiologists, and registered dieticians who were not in our proposed
list but have requested inclusion as MIPS eligible clinicians. We are
finalizing to modify Sec. 414.1305 the definition of a MIPS eligible
clinician to include: Beginning with the 2021 MIPS payment year, a
physical therapist, occupational therapist, qualified speech-language
pathologist; a qualified audiologist (as defined in section
1861(ll)(3)(B) of the Act); clinical psychologist (as defined by the
Secretary for purposes of section 1861(ii) of the Act); and registered
dietician or nutrition professional; and a group that includes such
clinicians. We note that we do not have discretion under the statute to
include clinicians other than those specified in section
1848(q)(1)(C)(II) of the Act. Thus, nurses and pharmacists would not be
able to participate in MIPS.
Comment: A few commenters requested that clinical social workers
not be included in MIPS. They stated several reasons why they believe
that clinical social workers should not be included in MIPS: (1) Many
of their clinicians are solo or small group practices and do not have
the technology infrastructure in place to effectively meet expectations
in the Promoting Interoperability performance category; (2) many are in
private practice and have limited ability to influence the overall care
of patients limiting their ability to manage the overall cost of the
beneficiary; (3) while there are more than six measures available in
the mental/behavioral health measure set there are only four claims
measures appropriate for use by clinical social workers as determined
by eligible CPT codes and scope of practice; and (4) some of the
available MIPS CQM measures are limited by patient diagnosis, such as
dementia, which may further limit a clinical social workers ability to
effectively report on six quality measures, as there are only two
outcome measures in the Mental/Behavioral health measure set for
clinical social workers and they require the utilization of the PHQ-9
measure which is only reportable via EHR. When a clinical social worker
does not utilize EHR technology there may be further limitations to
reporting adequate measures.
Response: After review of the additional information regarding
quality measures, we revisited our findings and found support for the
comments. We were persuaded by the arguments of the specialties who
requested to be included in the program including: Physical therapists;
occupational therapists; speech-language pathologists; audiologists;
clinical psychologists; and dieticians or nutrition professionals. We
understand the issues that have been highlighted by the commenters and
believe that some clinical social workers may have a difficult time
successfully participating in MIPS. Therefore, we agree that clinical
social workers should not be added as a MIPS eligible clinician at this
time. However, we do believe that they may be able to participate at
some point in the future. From our analysis, clinical social workers
may not have six applicable quality measures to report at this time.
For example, some measures may contain CPT codes utilized by clinical
social workers, but may not be applicable to their practice. We do
believe that there is at least one quality measure that clinical social
workers

[[Page 59724]]

could report for MIPS. Therefore, we are modifying our proposal by
removing clinical social workers and certified nurse-midwives from our
proposed list and including qualified speech-language pathologists,
qualified audiologists, and registered dieticians who were not in our
proposed list but have requested inclusion as MIPS eligible clinicians.
We are finalizing to modify Sec. 414.1305 the definition of a MIPS
eligible clinician to include, beginning with the 2021 MIPS payment
year, a physical therapist, occupational therapist, qualified speech-
language pathologist; a qualified audiologist (as defined in section
1861(ll)(3)(B) of the Act); clinical psychologist (as defined by the
Secretary for purposes of section 1861(ii) of the Act); and registered
dietician or nutrition professional; and a group that includes such
clinicians. We encourage clinicians who are not eligible to participate
in MIPS to voluntarily report on applicable measures and activities for
MIPS. The data received will not be used to assess performance for the
purpose of the MIPS payment adjustment; however, these clinicians will
have the opportunity to access feedback on their submitted MIPS data.
We agree that the two outcome measures within the mental/behavioral
health specialty measure set do require the utilization of the PHQ-9 to
measure the depression outcome; however, we disagree with the commenter
as this is not restricted to EHR and available by MIPS CQMs
Specification.
Comment: One commenter recommended that we adopt a standard
definition of a Quality Payment Program eligible provider, eligible
clinician and/or an eligible professional as it continues to expand the
list of eligible clinicians. The commenter recommended the word
``physician'' be replaced with provider and/or clinician, stating that
this terminology better reflects the collaboration of the current
inter-professional healthcare team.
Response: We understand the commenter to be suggesting that we
unify the definitions of eligible clinician and MIPS eligible
clinician. While we agree that a unified definition might have certain
benefits, we believe that two separate definitions are necessary as the
two tracks of the Quality Payment Program (MIPS and APM) have
distinctly different requirements for participation and the term
eligible clinicians reflects, a broader set of clinician types than the
term MIPS eligible clinicians. We note that both terms already refer to
clinicians.
Comment: Some commenters stated that inclusion of these additional
eligible clinicians in the program with just two months' notice is
overly burdensome and would ultimately prove counterproductive. One
commenter stated that because of the limited scope of MIPS reporting
that is applicable to these specialties, we should carefully evaluate
whether the expense and added burden of reporting for these specialties
is commensurate with the benefits. Another commenter noted that these
clinicians tend to have a high patient turnover rate, which could make
certain measures challenging. Several commenters opposed expanding the
definition of eligible clinician to the proposed clinician types,
stating that the clinician types do not, as a general rule, encompass
the same types of workflows as current MIPS eligible clinicians, and,
therefore, adding these clinicians could increase the cost, time, and
effort for reporting and documentation. Many commenters requested we
create ramp-up policies for the additional eligible clinicians, such as
a pick-your-pace approach or a 1-year delayed effective date. Likewise,
a few commenters requested that we allow the additional clinicians to
opt-in for the first year in which they are eligible to participate. A
few commenters requested that we consider a one-time bonus payment for
voluntary reporting, and requested modified quality benchmarks,
performance thresholds, reporting requirements, and data completeness
requirements.
Response: We acknowledge that adding these additional clinicians
will require some adaptation to the current systems and processes and
will take careful consideration by measure stewards to determine the
appropriateness of adding clinician encounters to align with measure
intent. However, we believe the benefits outweigh the costs as these
clinicians are an integral part of the health care delivery team. We
believe that all eligible clinicians benefit from participation in
quality reporting under MIPS and help reach one of our strategic
objectives to improve beneficiary outcomes and engage and empower
consumers by providing healthcare information useful for driving value
and making healthcare decisions. Regarding measures that are considered
challenging, the additional clinicians should choose measures and
activities that are applicable and meaningful to them. As noted in the
proposed rule (83 FR 35884), the MIPS program is still ramping up, and
we will continue to increase the performance threshold to ensure a
gradual and incremental transition to the performance threshold that
will be used in the Quality Payment Program Year 6. Therefore, if
specified as MIPS eligible clinicians beginning with the 2021 MIPS
payment year, the additional eligible clinicians would have 4 years in
the program in order to ramp up. Conversely, if specified as MIPS
eligible clinicians beginning in a future year, they would be afforded
less time to ramp up the closer the program gets to Quality Payment
Program Year 6. In addition, for the first 2 years of MIPS, clinicians
who are not MIPS eligible had the opportunity to voluntarily report to
become familiar with MIPS measures and reporting. For these reasons, we
do not believe we should adopt policies such as those suggested by the
commenters. We note that additional eligible clinicians that exceed at
least one, but not all, of the low-volume threshold criteria will have
the opportunity to opt-in to participate in MIPS as discussed in
section III.I.3.c.(5) of this final rule. We do not agree with offering
a one-time bonus payment for voluntary reporting as section
1848(q)(1)(C)(vi) of the Act precludes the application of a MIPS
adjustment factor (or additional MIPS adjustment factor) to an
individual who is not a MIPS eligible clinician. Finally, as these
additional clinicians will be defined as MIPS eligible clinicians, they
will be subject to the same requirements as other MIPS eligible
clinicians, including quality benchmarks, performance thresholds,
reporting requirements, and data completeness requirements.
Comment: Several commenters requested that we provide targeted
education on program requirements to additional eligible clinicians.
Specifically, the commenters urged us to provide compliance support to
small practices, by creating an industry pathway to EHR reporting. A
few commenters requested that we convene a Technical Expert Panel (TEP)
comprised of individuals representing the additional eligible clinician
types to inform adaptation of the Quality Payment Program to meet their
needs.
Response: We have consistently provided targeted education on
program requirements in the past and intend to continue doing so
through various means including: Webinars, national provider calls,
virtual office hours, speaking engagements, and tailored educational
resources for the additional clinicians. No cost technical assistance
is also available by contacting the Quality Payment Program Service
Center by phone at 1-866-288-8292, (TTY) 1-877-715-6222 or by email at
[email protected]. We will also continue to support small and rural

[[Page 59725]]

practices by offering free and customized resources available within
local communities, including direct, one-on-one support from the Small,
Underserved, and Rural Support Initiative along with our other no-cost
technical assistance. We appreciate the suggestion to convene a TEP
comprised of the additional clinicians. We will continue to explore
additional opportunities for this type of engagement in the future.
Comment: Many commenters noted their concern regarding whether the
Quality Payment Program could be utilized for these new clinician
types, asking us to consider if these clinicians are able to meet MIPS
reporting requirements across all performance categories before
expanding the list of MIPS-eligible clinicians. Specifically, some
commenters stated that the Promoting Interoperability performance
category would be difficult to meet without a change in meaningful use
guidelines, noting that because these clinicians rarely bill the
clinician group directly and may not be integrated with the clinician
group's EHR, interoperability remains a material issue. These
commenters requested that we weight the Promoting Interoperability
performance category at zero percent or allow new eligible clinicians
to opt-in to this performance category. Another commenter requested
clarification on whether the proposal to automatically assign a zero
percent weighting for the Promoting Interoperability performance
category for these new types of MIPS eligible clinicians applies to
both individual clinicians and groups. Another commenter asked for
clarification regarding if they could continue to report as a group.
One commenter questioned whether the additional clinicians would be
removed from the denominator for these measures. Other commenters asked
for clarification on how quality measures will be captured as most of
these clinicians may not have electronic medical records (EMRs).
Response: In the CY 2019 PFS proposed rule (83 FR 35883 through
35884) to assess whether these additional eligible clinicians could
successfully participate in MIPS, we evaluated whether there would be
sufficient measures and activities applicable and available for each of
the additional eligible clinician types. We did not focus on the
Promoting Interoperability performance category because for CY 2019 we
are finalizing to automatically assign a zero percent weighting for the
Promoting Interoperability performance category which will be
reweighted to the quality performance category for these new types of
MIPS eligible clinicians. In response to the comment, the proposal to
automatically assign a zero percent weighting for the Promoting
Interoperability performance category does apply to both individual
clinicians and groups. Clinicians may choose to report for MIPS as an
individual or as part of a group. If the clinician chooses to report as
part of a group, then under the policy we established previously (82 FR
53687), all of the MIPS eligible clinicians in the group must qualify
for a zero percent weighting in order for the Promoting
Interoperability performance category to be reweighted in the final
score. We refer readers to section III.I.3.h.(5)(h)(ii) of this final
rule for further details on the policy that we are finalizing in this
rule to automatically assign a zero percent weighting for the Promoting
Interoperability performance category. Regarding data submission
requirements for quality measures, the additional eligible clinicians
may submit their quality data through the same data collection types
available to all MIPS eligible clinicians including eCQMs, MIPS
Clinical Quality Measures (MIPS CQMs), QCDR measures, Medicare Part B
claims measures, CMS Web Interface measures, the CAHPS for MIPS survey,
and administrative claims measures which may be submitted via one of
the submission types including: Direct; log in and upload; log in and
attest; Medicare Part B claims; and the CMS Web Interface. We refer
readers to section III.I.3.h.(1) in this final rule for further
information regarding performance category measures and reporting.
Comment: A few commenters requested that we be certain that we are
operationally prepared to support reporting and scoring for the
additional eligible clinician types, as clinicians have experienced
operational data submissions issues in the past.
Response: We intend to have our Quality Payment Program portal
ready to accept and process data for all MIPS eligible clinicians for
2021 MIPS payment year.
Comment: Several commenters requested clarification on how our
proposal would apply to eligible clinicians billing under a hospital-
or facility-based TIN. A few commenters stated that the rule does not
indicate whether hospitals should report the NPI of these clinicians on
the UB-04 claims used by hospitals and cautioned that adding these
clinician types to UB-04 claims would entail significant administrative
burden to hospitals. One commenter also stated that the majority of
facility-based outpatient therapy claims do not contain the rendering
NPI and usually contain just a facility NPI; therefore, most facility-
based outpatient therapy claims will not be eligible for MIPS. A few
commenters said that due to a technicality in how facility-based claims
(such as those submitted by inpatient rehabilitation facilities) are
submitted, only independently rendered, private practice outpatient
therapy services will be included in MIPS, and facility-based
outpatient therapy will generally not be included. One commenter
recommended that we operationalize the inclusion of facility-based
clinicians in MIPS by treating the facility NPI as a MIPS-participating
NPI and allow the facility to report measures under MIPS like a group.
Another commenter argued that facility-based outpatient therapy
clinicians should be included in the program. A few commenters sought
clarification of how clinicians of therapy services in skilled-nursing
facilities will be treated, stating that assessing individual
clinicians for quality and adjusting payment poses unique challenges in
this setting.
Response: These additional clinicians will be defined as MIPS
eligible clinicians and will be subject to the same requirements as
other MIPS eligible clinicians billing under a hospital- or facility-
based TIN. MIPS eligible clinician may report as an individual or as
part of a group. We finalized at Sec. 414.1380(e)(2)(i) and (ii) the
determination of a facility-based individual and facility-based group.
A facility-based individual is a MIPS eligible clinician that furnishes
75 percent or more of his or her covered professional services in sites
of service identified by the place of service codes used in the HIPAA
standard transaction as an inpatient hospital or emergency room setting
based on claims for a period prior to the performance period as
specified by CMS. A facility-based group is a group in which 75 percent
or more of its eligible clinician NPIs billing under the group's TIN
meet the facility-based individual determination. Therefore, if a MIPS
eligible clinician is submitting their data as part of a facility-based
group their NPI number would need to be annotated on the claim which is
part of normal billing practices. We refer readers to section
III.I.3.h.(2)(a)(iv) of this final rule for further details regarding
the application of facility-based measures. The definition of a
hospital-based clinician finalized at Sec. 414.1410 is primarily
applicable to the Promoting Interoperability performance category. We
refer readers to the CY 2018 Quality Payment Program final rule (82 FR

[[Page 59726]]

53684) for details on a hospital-based clinician. We are aware that
facility-based outpatient therapy and skilled nursing facility claims
do not contain the rendering NPI and usually contain just a facility
NPI; therefore, facility-based outpatient therapy and skilled nursing
facility claims will not be eligible for MIPS. For those billed
Medicare Part B allowed charges we are able to associate with a MIPS
eligible clinician at an NPI level, such covered professional services
furnished by such clinicians would be included for purposes of applying
any MIPS payment adjustment. It is our intention to provide clinicians
with their eligibility status prior to the performance period through
the Quality Payment Program portal eligibility determination tool. This
should allow clinicians to know ahead of time whether they are included
in MIPS or not. We will take these comments into consideration in
future rulemaking.
Comment: A few commenters noted that adding physical and
occupational therapists would affect the determination of practice
size. One commenter expressed concern that groups may lose their small
group status even though the composition of the practice did not
change.
Response: We do not anticipate that the small practice size
determination will be affected by adding additional clinicians to the
definition of MIPS eligible clinician. Small practice is defined at
Sec. 414.1305 to mean a practice consisting of 15 or fewer eligible
clinicians. Thus, the definition of small practice already accounts for
all eligible clinicians in the practice, including those that we are
adding to the definition of MIPS eligible clinician.
Comment: One commenter requested clarification regarding how the
additional MIPS eligible clinicians would be subject to payment
reductions if they do not meet the performance requirements under MIPS.
Response: The additional eligible clinicians, who are not otherwise
excluded, will be included in the performance requirements for a MIPS
eligible clinician for CY 2021 payment year. In addition, MIPS eligible
clinicians are subject to the MIPS payment adjustment factor.
Clinicians who are considered MIPS eligible and who do not report under
MIPS may receive a final score of zero and an associated negative
payment adjustment of 7 percent during the CY 2021 payment year.
Comment: Some commenters stated that the additional clinician types
could water down the performance pool, and increasing the number of
participants will create increased competition for an additional
performance threshold, making it more difficult for disadvantaged
clinicians to meaningfully participate in MIPS.
Response: Although the number of MIPS eligible clinicians will
increase, we do not anticipate that the additional clinicians will
substantially change the total number of MIPS eligible clinicians or
make it more difficult for other clinicians to meaningfully participate
in MIPS. Regarding the additional performance threshold, we note that
the eligible clinician must first qualify for the additional
performance threshold for exceptional performance. We do not believe
that the addition of new clinician types to be MIPS eligible implies
they are going to perform at a level that qualifies for the additional
performance threshold. We refer readers to Table 98 in section VII
(Regulatory Impact Analysis) of this final rule for information
regarding the impact of expanding the definition of MIPS eligible
clinicians on the total number of MIPS eligible clinicians and the
total estimated PFS amount paid.
Comment: One commenter believed it was unnecessary to include the
proposed additional eligible clinicians as they would more than likely
be ineligible because they would fall below the low-volume threshold.
Response: We understand that some of the additional eligible
clinicians may not exceed the low-volume threshold. However, as
discussed in section III.I.3.c.(5) of this final rule, we are also
finalizing an opt-in option that will allow eligible clinicians to opt-
in to MIPS if the eligible clinician or group meets or exceeds at least
one, but not all, of the low-volume threshold criteria. In addition,
MIPS eligible clinicians may participate in MIPS as part of a group or
virtual group which should improve their ability to exceed the low-
volume threshold. We believe this option would allow the additional
eligible clinicians the opportunity to participate in MIPS if they
desired to do so.
Comment: Several commenters suggested that there is misalignment
between the proposed expanded list of eligible clinician types for the
MIPS and the scope of clinician types for the Advanced Alternative
Payment Model path under the Quality Payment Program. Specifically, a
few commenters noted that, currently, a number of clinician types (for
example, clinical psychologists and certified nurse midwives) could be
in an Advanced APM, but that we are proposing to include clinician
types for MIPS that may not be eligible for the Advanced APM path under
the Quality Payment Program. Thus, commenters suggested that we
standardize the included clinician types across the Quality Payment
Program unless there are appropriate clinical reasons for differences.
One commenter requested clarification as to whether physical,
occupational, and speech therapists, as eligible clinicians, can
participate in the Advanced APMs path under the Quality Payment
Program. Another commenter requested that we provide guidance on how
APM entities, ACOs, and other health care organizations should identify
these clinician types on their clinician participation lists.
Response: We note that the proposed expanded list of eligible
clinician types for the MIPS is not misaligned with the scope of
eligible clinicians for the Advanced APMs path under the Quality
Payment Program. In accordance with section 1848(q)(1)(C)(i)(I) of the
Act, we defined MIPS eligible clinician for the 2019 and 2020 MIPS
payment years to include only physicians (as defined under section
1861(r) of the Act), physician assistants, nurse practitioners,
clinician nurse specialists, and certified registered nurse
anesthetists (and groups that include these clinicians). In contrast,
we explained in the CY 2017 Quality Payment Program final rule (81 FR
77405 through 77406), for the Advanced APM path under the Quality
Payment Program, the term ``eligible clinician'' is defined in section
1833(z)(3)(B) of the Act (by cross-reference to the definition of
``eligible professional'' in section 1848(k)(3)(B) of the Act), and
includes: Physicians, physician assistants, nurse practitioners,
clinical nurse specialists, certified registered nurse anesthetists,
certified nurse-midwives, clinical social workers, clinical
psychologists, registered dietitians or nutrition professionals,
physical or occupational therapists, qualified speech-language
pathologists, and qualified audiologists, and a group that includes
these professionals. Our proposed expansion of the list of MIPS
eligible clinician types would actually align with the current scope of
eligible clinicians under the Advanced APM path of the Quality Payment
Program. Currently, any of those eligible clinicians who participate
sufficiently in Advanced APMs can become QPs for a year and receive the
associated APM Incentive Payment. We note that each APM has its own
focus, and many offer participation opportunities for a broad scope of
eligible clinicians. Although the design of existing or future APMs is
beyond the scope of this final rule, we welcome ideas on how to further
engage

[[Page 59727]]

the full scope of eligible clinicians as we work hard to develop more
APM opportunities. Additionally, we finalized in the CY 2017 Quality
Payment Program final rule (81 FR 77442) that the eligible clinicians
for whom we would make QP determinations would be all the eligible
clinicians participating in an APM Entity in an Advanced APM, as
identified at each of three snapshot dates, during a QP Performance
Period. The eligible clinicians for whom we make QP determinations are
those identified on an Advanced APM's Participation List or Affiliated
Practitioner List on one of those three dates. Lastly, we note that
decisions about the eligible clinicians that are included on the
Participation List or Affiliated Practitioner List for any particular
Advanced APM are made based on the specific terms and conditions of the
Advanced APM, which can vary based on the model test, entities
involved, payment arrangements, and other factors.
After consideration of the public comments received, we are
finalizing a modification of our proposal to amend Sec. 414.1305 to
revise the definition of a MIPS eligible clinician, as identified by a
unique billing TIN and NPI combination used to assess performance, to
mean any of the following (excluding those identified at Sec.
414.1310(b)): A physician (as defined in section 1861(r) of the Act); a
physician assistant, nurse practitioner, and clinical nurse specialist
(as such terms are defined in section 1861(aa)(5) of the Act); a
certified registered nurse anesthetist (as defined in section
1861(bb)(2) of the Act); beginning with the 2021 MIPS payment year, a
physical therapist, occupational therapist, qualified speech-language
pathologist; qualified audiologist (as defined in section
1861(ll)(3)(B) of the Act); clinical psychologist (as defined by the
Secretary for purposes of section 1861(ii) of the Act); and registered
dietician or nutrition professional; and a group that includes such
clinicians.
b. MIPS Determination Period
As discussed in the proposed rule (83 FR 35884 through 35886),
currently MIPS uses various determination periods to identify certain
MIPS eligible clinicians for consideration for certain applicable
policies. For example, the low-volume threshold, non-patient facing,
small practice, hospital-based, and ambulatory surgical center (ASC)-
based determinations are on the same timeline with slight differences
in the claims run-out policies, whereas the facility-based
determinations has a slightly different determination period. The
virtual group eligibility determination requires a separate election
process. We proposed to add a virtual group eligibility determination
period beginning in CY 2020 as discussed in section III.I.3.f.(2)(a) of
this final rule. In addition, the rural and HPSA determinations do not
utilize a determination period.
Under Sec. 414.1305, the low-volume threshold determination period
is described as a 24[dash]month assessment period consisting of an
initial 12[dash]month segment that spans from the last 4 months of the
calendar year 2 years prior to the performance period through the first
8 months of the calendar year preceding the performance period, and a
second 12[dash]month segment that spans from the last 4 months of the
calendar year 1 year prior to the performance period through the first
8 months of the calendar year performance period. An individual
eligible clinician or group that is identified as not exceeding the
low-volume threshold during the initial 12[dash]month segment will
continue to be excluded under Sec. 414.1310(b)(1)(iii) for the
applicable year regardless of the results of the second 12-month
segment analysis. For the 2020 MIPS payment year and future years, each
segment of the low-volume threshold determination period includes a 30-
day claims run out.
Under Sec. 414.1305, the non-patient facing determination period
is described as a 24[dash]month assessment period consisting of an
initial 12[dash]month segment that spans from the last 4 months of the
calendar year 2 years prior to the performance period through the first
8 months of the calendar year preceding the performance period and a
second 12[dash]month segment that spans from the last 4 months of the
calendar year 1 year prior to the performance period through the first
8 months of the calendar year performance period. An individual
eligible MIPS clinician, group, or virtual group that is identified as
non-patient facing during the initial 12-month segment will continue to
be considered non-patient facing for the applicable year regardless of
the results of the second 12[dash]month segment analysis. For the 2020
MIPS payment year and future years, each segment of the non-patient
facing determination period includes a 30[dash]day claims run out.
In the CY 2018 Quality Payment Program final rule (82 FR 53581), we
finalized that for the small practice size determination period, we
would utilize a 12-month assessment period, which consists of an
analysis of claims data that spans from the last 4 months of a calendar
year 2 years prior to the performance period followed by the first 8
months of the next calendar year and includes a 30-day claims run out.
In the CY 2017 Quality Payment Program final rule (81 FR 77238
through 77240), we finalized that to identify a MIPS eligible clinician
as hospital-based we would use claims with dates of service between
September 1 of the calendar year 2 years preceding the performance
period through August 31 of the calendar year preceding the performance
period, but in the event it is not operationally feasible to use claims
from this time period, we would use a 12-month period as close as
practicable to this time period.
In the CY 2018 Quality Payment Program final rule (82 FR 53684
through 53685), we finalized that to identify a MIPS eligible clinician
as ASC-based, we would use claims with dates of service between
September 1 of the calendar year 2 years preceding the performance
period through August 31 of the calendar year preceding the performance
period, but in the event it is not operationally feasible to use claims
from this time period, we would use a 12-month period as close as
practicable to this time period.
In the CY 2018 Quality Payment Program final rule (82 FR 53760), we
discussed, but did not finalize, our proposal or the alternative option
for how an individual clinician or group would elect to use and be
identified as using facility-based measurement for the MIPS program.
Because we were not offering facility-based measurement until the 2019
MIPS performance period, we did not need to finalize either of these
for the 2018 MIPS performance period. However, as discussed in section
III.I.3.i.(1)(d) of this final rule, we proposed to amend Sec.
414.1380(e)(2)(i)(A) to specify a criterion for a clinician to be
eligible for facility-based measurement. Specifically, that is, the
clinician furnishes 75 percent or more of his or her covered
professional services in sites of service identified by the place of
service codes used in the HIPAA standard transaction as an inpatient
hospital, on-campus outpatient hospital, or emergency room setting
based on claims for a 12-month segment beginning on October 1 of the
calendar year 2 years prior to the applicable performance period and
ending on September 30 of the calendar year preceding the applicable
performance period with a 30-days claims run out. We did not propose to
utilize the MIPS determination period for purposes of the facility-
based determination because for the facility-based determination, we
are only using the first segment of the MIPS determination period. We
are using the

[[Page 59728]]

first segment because the performance period for measures in the
hospital value-based purchasing program overlapped in part with that
determination period. If we were to use the second segment, we could
not be assured that the clinician actually worked in the hospital on
which their MIPS score would be based during that time. We believe this
approach provides clarity and is a cleaner than providing a special
exception for the facility-based determination in the MIPS
determination period for the second segment. We refer readers to
section III.I.3.i.(1)(d) for further details on the facility-based
determinations and the time periods that are applicable to those
determinations.
In the CY 2018 Quality Payment Program final rule (82 FR 53602
through 53604), we finalized that for the virtual group eligibility
determination period, we would utilize an analysis of claims data
during an assessment period of up to 5 months that would begin on July
1 and end as late as November 30 of the calendar year prior to the
applicable performance period and include a 30-day claims run out. To
capture a real-time representation of TIN size, we finalized that we
would analyze up to 5 months of claims data on a rolling basis, in
which virtual group eligibility determinations for each TIN would be
updated and made available monthly. We noted that an eligibility
determination regarding TIN size is based on a relative point in time
within the 5-month virtual group eligibility determination period, and
not made at the end of such 5-month determination period. Beginning
with the 2019 performance period, we proposed to amend Sec.
414.1315(c)(1) to establish a virtual group eligibility determination
period to align with the first segment of the MIPS determination
period, which includes an analysis of claims data during a 12-month
assessment period (fiscal year) that would begin on October 1 of the
calendar year 2 years prior to the applicable performance period and
end on September 30 of the calendar year preceding the applicable
performance period and include a 30-day claims run out. We refer
readers to section III.I.3.f.(2)(a) of this final rule for further
details on this proposal.
In addition, we have established other special status
determinations, including rural area and HPSA. Rural area is defined at
Sec. 414.1305 as a ZIP code designated as rural, using the most recent
Health Resources and Services Administration (HRSA) Area Health
Resource File data set available. HPSAs are defined at Sec. 414.1305
as areas designated under section 332(a)(1)(A) of the Public Health
Service Act.
We understand that the current use of various MIPS determination
periods is complex and causes confusion. Therefore, beginning with the
2021 MIPS payment year, we proposed to consolidate several of these
policies into a single MIPS determination period that would be used for
purposes of the low-volume threshold and to identify MIPS eligible
clinicians as non-patient facing, a small practice, hospital-based, and
ASC-based, as applicable. We did not propose to include the facility-
based or virtual group eligibility determination periods or the rural
and HPSA determinations in the MIPS determination period, as they each
require a different process or timeline that does not align with the
other determination periods, or do not utilize determination periods.
We invited public comments on the possibility of incorporating these
determinations into the MIPS determination period in the future.
There are several reasons we believe a single MIPS determination
period for most of the eligibility criteria is the most appropriate.
First, it would simplify the program by aligning most of the MIPS
eligibility determination periods. Second, it would continue to allow
us to provide eligibility determinations as close to the beginning of
the performance period as feasible. Third, we believe a timeframe that
aligns with the fiscal year is easier to communicate and more
straightforward to understand compared to the current determination
periods. Finally, it would allow us to extend our data analysis an
additional 30 days.
It is important to note that during the final 3 months of the
calendar year in which the performance period occurs, in general, we do
not believe it would be feasible for many MIPS eligible clinicians who
join an existing practice (existing TIN) or join a newly formed
practice (new TIN) to participate in MIPS as individuals. We refer
readers to section III.I.3.i.(2)(b) of this final rule for more
information on the proposed reweighting policies for MIPS eligible
clinicians who join an existing practice or who join a newly formed
practice during this timeframe.
We requested comments on our proposal that beginning with the 2021
MIPS payment year, the MIPS determination period would be a 24-month
assessment period including a two-segment analysis of claims data
consisting of: (1) An initial 12-month segment beginning on October 1
of the calendar year 2 years prior to the applicable performance period
and ending on September 30 of the calendar year preceding the
applicable performance period; and (2) a second 12-month segment
beginning on October 1 of the calendar year preceding the applicable
performance period and ending on September 30 of the calendar year in
which the applicable performance period occurs. The first segment would
include a 30[dash]day claims run out. The second segment would not
include a claims run out, but would include quarterly snapshots for
informational use only, if technically feasible. For example, a
clinician could use the quarterly snapshots to understand their
eligibility status between segments. Specifically, we believe the
quarterly snapshots would be helpful for new TIN/NPIs and TINs created
between the first segment and the second segment allowing them to see
their preliminary eligibility status sooner. Without the quarterly
snapshots, these clinicians would not have any indication of their
eligibility status until just before the submission period. An
individual eligible clinician or group that is identified as not
exceeding the low-volume threshold, or a MIPS eligible clinician that
is identified as non-patient facing, a small practice, hospital-based,
or ASC-based, as applicable, during the first segment would continue to
be identified as such for the applicable MIPS payment year regardless
of the second segment. For example, for the 2021 MIPS payment year, the
first segment would be October 1, 2017 through September 30, 2018, and
the second segment would be October 1, 2018 through September 30, 2019.
However, based on our experience with the Quality Payment Program, we
believe that some eligible clinicians, whose TIN or TIN/NPIs are
identified as eligible during the first segment and do not exist in the
second segment, are no longer utilizing these same TIN or TIN/NPI
combinations. Therefore, because those TIN or TIN/NPIs would not exceed
the low-volume threshold in the second segment, they would no longer be
eligible for MIPS. For example, in the 2019 performance period a
clinician exceeded the low-volume threshold during the first segment of
the determination period (data from the end of CY 2017 to early 2018)
under one TIN; then in CY 2019 the clinician switches practices under a
new TIN and during segment two of the determination period. Therefore,
it is determined that the clinician is not eligible (based on CY 2019
data) under either TIN. This clinician would not be eligible to
participate in MIPS based on either segment of the determination

[[Page 59729]]

period because the TIN that was assessed for the first segment of the
determination period no longer exists. So there are no charges or
services that would be available to assess in the second segment for
that TIN and the new TIN assessed during the second segment was not
eligible. In this scenario, though the clinician exceeded the low-
volume threshold criteria initially, the clinician is not required to
submit any data based on TIN eligibility determinations. However, it is
important to note that if a TIN or TIN/NPI did not exist in the first
segment but does exist in the second segment, these eligible clinicians
could be eligible for MIPS. For example, the eligible clinician may not
find their TIN or TIN/NPI in the Quality Payment Program lookup tool
but may still be eligible if they exceed the low-volume threshold in
the second segment. We proposed to incorporate this policy into our
proposed definition of MIPS determination period at Sec. 414.1305. We
also requested comments on our proposals to define MIPS determination
period at Sec. 414.1305 and modify the definitions of low-volume
threshold, non-patient facing, a small practice, hospital-based, and
ASC-based at Sec. 414.1305 to incorporate references to the MIPS
determination period.
The following is a summary of the public comments received on our
proposals and our responses:
Comment: Several commenters supported our proposal, noting that the
varying determination periods add unnecessary confusion and this policy
would reduce complexity. One commenter recommended we continue our
efforts to align the determination period with facility-based, virtual
groups, and rural and HPSA eligibility determinations.
Response: We appreciate the commenters' support.
Comment: Some commenters stated that in order for clinicians to
successfully perform over a 12-month period for the cost and quality
performance categories, the clinician must know before the start of the
performance period their full eligibility status for MIPS.
Response: We understand that it is important for clinicians to know
their eligibility status prior to the performance period. It is our
intention to provide eligibility determinations as close to the
beginning of the performance period as feasible. We would like to
assure commenters that we are working diligently to provide clinicians
with this information at the earliest time possible.
Comment: A few commenters supported using quarterly snapshots for
the second segment of the MIPS determination period to show preliminary
eligibility status. One commenter recommended that the first quarterly
snapshot for the second segment be mandated to be available in the
look-up tool no later than January 1, 2019, the first day of the CY
2019 performance period. One commenter recommended that if a clinician
does not exceed the low-volume threshold during the quarterly
snapshots, then they should be automatically excluded from MIPS unless
further snapshots allow for an opt-in similar to the proposed low-
volume threshold opt-in policy.
Response: While the statute does not require the use of quarterly
snapshots, we believe the snapshots may provide useful information for
eligible clinicians. Therefore, we are working to provide the quarterly
snapshots, if feasible. In addition, it is important to note that the
quarterly snapshots are being provided for informational use only and
are not final until after the second segment of the MIPS determination
period closes and a reconciliation between the segments occurs. Since
the quarterly snapshots are not final this information is subject to
change and should not be considered the final eligibility
determination. The eligibility determination will be made after a
reconciliation of the first and second segment of the MIPS
determination period.
Comment: Several commenters did not support the proposed 24-month
MIPS determination period, with most arguing for a single determination
period. These commenters recommended that the MIPS determination period
be a single, 12-month segment beginning on October 1 of the calendar
year preceding the applicable performance period and ending on
September 30 of the calendar year in which the applicable performance
period occurs. Another commenter stated that a preliminary assessment
for the exclusions would be useful, but the final decision should be
made only based on performance period data. One commenter stated that
the two segments lead to confusion and uncertainty about participation
status and requested that the second segment have an end date and
notification date prior to the start of the performance year. Another
commenter opposed the shift in determination period dates unless the
eligibility tool on the Quality Payment Program website is updated in a
timely fashion prior to the performance year.
Response: If we had a singular eligibility determination period we
would not be able to identify eligible clinicians who switch practices
between the first and second segments of the MIPS determination period.
We estimate that this would affect approximately 13 percent of MIPS
eligible clinicians who may switch practices between the first and
second determination periods. If we did not conduct the first segment
analyses then there would be no way to inform clinicians of their
eligibility status prior to the performance period. The second segment
accounts for the identification of additional, previously unidentified
individual eligible clinicians and groups who do not exceed the low-
volume threshold or meet other special circumstances. It is our
intention that the eligibility tool on the Quality Payment Program
website will be updated to provide eligibility determinations prior to
the start of the performance period.
Comment: A few commenters noted the challenge for clinicians who
exceeded the low-volume threshold during the first segment of the MIPS
determination period and then discovered late in the performance
period, after the second segment of the MIPS determination period that
they are no longer eligible. One commenter suggested that if a
clinician exceeds the low-volume threshold during the second segment of
MIPS eligibility determination period, the clinician should remain
excluded unless the clinician opts-in. One commenter noted that these
issues may be less of a problem if the opt-in proposal is finalized.
Another commenter requested the definition of the MIPS determination
period be expanded to account for scenarios when an eligible clinician
or group exceeded the low-volume threshold during the first segment but
falls below the low-volume threshold during the second segment or when
a eligible clinician or group is not categorized as a special status
(such as non-patient facing) during the first segment but gains special
status during the second segment.
Response: We agree that the issues identified by the commenters may
be alleviated with the opt-in policy. If an eligible clinician finds
out following the second segment of the MIPS determination period that
they are no longer eligible to participate in MIPS and they meet the
requirements of the opt-in policy they may choose to participate in
MIPS by opting-in to MIPS. Regarding changing statuses between the two
segments of the MIPS determination period, we are finalizing

[[Page 59730]]

the definition of the MIPS determination period at Sec. 414.1305(2)
that subject to Sec. 414.1310(b)(1)(iii), an individual eligible
clinician or group that is identified as not exceeding the low-volume
threshold or as having special status during the first segment of the
MIPS determination period will continue to be identified as such for
the applicable MIPS payment year regardless of the results of the
second segment of the MIPS determination period. An individual eligible
clinician or group for which the unique billing TIN and NPI combination
is established during the second segment of the MIPS determination
period will be assessed based solely on the results of that segment.
While we would like to ensure that there is as much flexibility as
possible within the MIPS program, we believe it is important that MIPS
eligible clinicians choose how they will participate in MIPS as a
whole, either as an individual or as a group. Whether MIPS eligible
clinicians participate in MIPS as an individual or group, it is
critical for us to assess the performance of individual MIPS eligible
clinicians or groups across the four performance categories
collectively as either an individual or group in order for the final
score to reflect performance at a true individual or group level and to
ensure the comparability of data.
After consideration of the public comments received, we are
finalizing our proposal to define MIPS determination period at Sec.
414.1305 beginning with the 2021 MIPS payment year, as a 24-month
assessment period including a two-segment analysis of claims data
consisting of: (1) An initial 12-month segment beginning on October 1
of the calendar year 2 years prior to the applicable performance period
and ending on September 30 of the calendar year preceding the
applicable performance period; and (2) a second 12-month segment
beginning on October 1 of the calendar year preceding the applicable
performance period and ending on September 30 of the calendar year in
which the applicable performance period occurs. The first segment would
include a 30-day claims run out. The second segment would not include a
claims run out, but would include quarterly snapshots for informational
use only, if technically feasible. In addition, we are finalizing that
subject to Sec. 414.1310(b)(1)(iii), an individual eligible clinician
or group that is identified as not exceeding the low-volume threshold
or as having special status during the first segment of the MIPS
determination period will continue to be identified as such for the
applicable MIPS payment year regardless of the results of the second
segment of the MIPS determination period. An individual eligible
clinician or group for which the unique billing TIN and NPI combination
is established during the second segment of the MIPS determination
period will be assessed based solely on the results of that segment.
Finally, at Sec. 414.1305 we are finalizing our proposal to modify the
definitions of low-volume threshold, non-patient facing MIPS eligible
clinician, a small practice, hospital-based MIPS eligible clinician,
and ASC-based MIPS eligible clinician at Sec. 414.1305 to incorporate
references to the MIPS determination period.
c. Low-Volume Threshold
(1) Overview
As discussed in the CY 2019 PFS proposed rule (83 FR 35886),
section 1848(q)(1)(C)(iv) of the Act, as amended by section
51003(a)(1)(A)(ii) of the Bipartisan Budget Act of 2018, provides that,
for performance periods beginning on or after January 1, 2018, the low-
volume threshold selected by the Secretary may include one or more or a
combination of the following (as determined by the Secretary): (1) The
minimum number of part B-enrolled individuals who are furnished covered
professional services (as defined in section 1848(k)(3)(A) of the Act)
by the eligible clinician for the performance period involved; (2) the
minimum number of covered professional services furnished to part B-
enrolled individuals by such clinician for such performance period; and
(3) the minimum amount of allowed charges for covered professional
services billed by such clinician for such performance period.
Under Sec. 414.1310(b)(1)(iii), for a year, eligible clinicians
who do not exceed the low-volume threshold for the performance period
with respect to a year are excluded from MIPS. Under Sec. 414.1305,
the low-volume threshold is defined as, for the 2019 MIPS payment year,
the low-volume threshold that applies to an individual eligible
clinician or group that, during the low-volume threshold determination
period, has Medicare Part B allowed charges less than or equal to
$30,000 or provides care for 100 or fewer Part B-enrolled Medicare
beneficiaries. In addition, for the 2020 MIPS payment year and future
years, the low-volume threshold is defined as the low-volume threshold
that applies to an individual eligible clinician or group that, during
the low-volume threshold determination period, has Medicare Part B
allowed charges less than or equal to $90,000 or provides care for 200
or fewer Part B-enrolled Medicare beneficiaries. The low-volume
threshold determination period is a 24-month assessment period
consisting of: (1) An initial 12-month segment that spans from the last
4 months of the calendar year 2 years prior to the performance period
through the first 8 months of the calendar year preceding the
performance period; and (2) a second 12-month segment that spans from
the last 4 months of the calendar year 1 year prior to the performance
period through the first 8 months of the calendar year performance
period. An individual eligible clinician or group that is identified as
not exceeding the low-volume threshold during the initial 12-month
segment will continue to be excluded under Sec. 414.1310(b)(1)(iii)
for the applicable year regardless of the results of the second 12-
month segment analysis. For the 2019 MIPS payment year, each segment of
the low-volume threshold determination period includes a 60-day claims
run out. For the 2020 MIPS payment year, each segment of the low-volume
threshold determination period includes a 30-day claims run out.
(2) Amendments To Comply With the Bipartisan Budget Act of 2018
In the CY 2019 PFS proposed rule (83 FR 35887), we proposed to
amend Sec. 414.1305 to modify the definition of low-volume threshold
in accordance with section 1848(q)(1)(C)(iv) of the Act, as amended by
section 51003(a)(1)(A)(ii) of the Bipartisan Budget Act of 2018.
Specifically, we requested comments on our proposals that for the 2020
MIPS payment year, we will utilize the minimum number (200 patients) of
Part B-enrolled individuals who are furnished covered professional
services by the eligible clinician or group during the low-volume
threshold determination period or the minimum amount ($90,000) of
allowed charges for covered professional services to Part B-enrolled
individuals by the eligible clinician or group during the low-volume
threshold determination period.
The following is a summary of the public comments received on our
proposals and our responses:
Comment: A few commenters supported the technical amendments passed
by Congress in the Bipartisan Budget Act of 2018, specifically noting
support for the proposal to not use Part B drugs for the low-volume
threshold determinations, and to rely instead on covered professional
services (instead of all Medicare Part B items and services) to
determine MIPS eligibility. Other commenters supported that items or
services beyond the PFS, especially Part B drugs, would not be subject
to the

[[Page 59731]]

MIPS payment adjustment factor or the MIPS additional payment
adjustment factor.
Response: We appreciate the commenters' support.
Comment: One commenter expressed concern about using covered
professional services for low-volume threshold determinations because
it could make it difficult for eligible clinicians and groups to
predict whether they are subject or excluded from MIPS. Additionally,
the commenter recommended that we provide timely notification based on
the results of the first determination period.
Response: We understand that utilizing covered professional
services rather than all Medicare Part B items and services is a
different approach to calculating the low-volume threshold. For the CY
2018 and CY 2019 MIPS payment years, we have utilized two calculations
in order to make low-volume threshold determinations: The number of
patients and the amount of allowed charges for each eligible clinician
or group. These calculations were based on the patients who were
furnished any Part B item or service, and on the allowed charges for
all Part B items and services. Beginning for the 2020 MIPS payment
year, the calculations will instead be based only on covered
professional services. A clinician may identify and monitor a claim to
distinguish covered professional services from Part B items and
services by calculating one professional claim line with positive
allowed charges to be considered one covered professional service. In
addition, we believe the quarterly snapshots will be helpful for new
TIN/NPIs and TINs created between the first segment and the second
segment allowing them to see their preliminary eligibility status
sooner. In addition, we believe these policies will allow clinicians to
understand their eligibility determination as close to the beginning of
the performance period as feasible.
After consideration of the public comments received, we are
finalizing our proposal to amend Sec. 414.1305 to modify the
definition of low-volume threshold to mean for the 2020 MIPS payment
year, we will utilize the minimum number (200 patients) of Part B-
enrolled individuals who are furnished covered professional services by
the eligible clinician or group during the low-volume threshold
determination period or the minimum amount ($90,000) of allowed charges
for covered professional services to Part B-enrolled individuals by the
eligible clinician or group during the low-volume threshold
determination period.
(3) MIPS Program Details
In the CY 2019 PFS proposed rule (83 FR 35887), we requested
comments on our proposal to modify Sec. 414.1310 to specify in
paragraph (a), Program Implementation, that except as specified in
paragraph (b), MIPS applies to payments for covered professional
services furnished by MIPS eligible clinicians on or after January 1,
2019. We also requested comments on our proposal to revise Sec.
414.1310(b)(1)(ii) to specify that for a year, a MIPS eligible
clinician does not include an eligible clinician that is a Partial
Qualifying APM Participant (as defined in Sec. 414.1305) and does not
elect, as discussed in section III.I.4.e. of this final rule, to report
on applicable measures and activities under MIPS. Finally, we requested
comments on our proposal to revise Sec. 414.1310(d) to specify that,
in no case will a MIPS payment adjustment factor (or additional MIPS
payment adjustment factor) apply to payments for covered professional
services furnished during a year by eligible clinicians (including
those described in paragraphs (b) and (c) of this section) who are not
MIPS eligible clinicians, including those who voluntarily report on
applicable measures and activities under MIPS.
We did not receive any comments regarding these proposals.
We are finalizing our proposal to modify Sec. 414.1310 to specify
in paragraph (a), Program Implementation, that except as specified in
paragraph (b), MIPS applies to payments for covered professional
services furnished by MIPS eligible clinicians on or after January 1,
2019. We are also finalizing our proposal to revise Sec.
414.1310(b)(1)(ii) to specify that for a year, a MIPS eligible
clinician does not include an eligible clinician that is a Partial
Qualifying APM Participant (as defined in Sec. 414.1305) and does not
elect, as discussed in section III.I.4.e. of this final rule, to report
on applicable measures and activities under MIPS. Finally, we are
finalizing our proposal to revise Sec. 414.1310(d) to specify that, in
no case will a MIPS payment adjustment factor (or additional MIPS
payment adjustment factor) apply to payments for covered professional
services furnished during a year by eligible clinicians (including
those described in paragraphs (b) and (c) of this section) who are not
MIPS eligible clinicians, including those who voluntarily report on
applicable measures and activities under MIPS.
(4) Addition of Low-Volume Threshold Criterion Based on Number of
Covered Professional Services
In the CY 2018 Quality Payment Program final rule (82 FR 53591), we
received several comments in response to the proposed rule regarding
adding a third criterion of items and services for defining the low-
volume threshold. We refer readers to that rule for further details.
As discussed in the CY 2019 PFS proposed rule (83 FR 35887) for the
2021 MIPS payment year and future years, we proposed to add one
additional criterion to the low-volume threshold determination--the
minimum number of covered professional services furnished to Part B-
enrolled individuals by the clinician. Specifically, we requested
comments on our proposal, for the 2021 MIPS payment year and future
years, that eligible clinicians or groups who meet at least one of the
following three criteria during the MIPS determination period will not
exceed the low-volume threshold: (1) Those who have allowed charges for
covered professional services less than or equal to $90,000; (2) those
who provide covered professional services to 200 or fewer Part B-
enrolled individuals; or (3) those who provide 200 or fewer covered
professional services to Part B-enrolled individuals.
For the third criterion, we proposed to set the threshold at 200 or
fewer covered professional services furnished to Part B-enrolled
individuals for several reasons. First, in the CY 2018 Quality Payment
Program final rule (82 FR 53589 through 53590), although we received
positive feedback from stakeholders on the increased low-volume
threshold, we also heard from some stakeholders that they would like to
participate in the program. Second, setting the third criterion at 200
or fewer covered professional services, combined with our proposed
policy with respect to opting in to MIPS, allows us to ensure that a
significant number of eligible clinicians have the ability to opt-in if
they wish to participate in MIPS. Finally, when we considered where to
set the low-volume threshold for covered professional services, we
examined two options: 100 or 200 covered professional services. For 100
covered professional services, there is some historical precedent. In
the CY 2017 Quality Payment Program final rule (81 FR 77062), we
finalized a low-volume threshold that excluded individual eligible
clinicians or groups that have Medicare Part B allowed charges less
than $30,000 or that provide care for 100 or fewer Part B-

[[Page 59732]]

enrolled Medicare beneficiaries; we believe the latter criterion is
comparable to 100 covered professional services. Conversely for 200
covered professional services, in the CY 2018 Quality Payment Program
final rule with comment period (82 FR 53588), we discussed that based
on our data analysis, excluding individual eligible clinicians or
groups that have Medicare Part B allowed charges less than or equal to
$90,000 or that provide care for 200 or fewer Part B-enrolled Medicare
beneficiaries decreased the percentage of MIPS eligible clinicians that
come from small practices. In addition, in the CY 2018 Quality Payment
final rule (82 FR 53955), we codified at Sec. 414.1380(b)(1)(iv) that
the minimum case requirements for quality measures are 20 cases, which
both services thresholds being considered (100 or 200) exceed. We also
codified at Sec. 414.1380(b)(1)(v) that the minimum case requirement
for the all-cause hospital readmission measure is 200 cases, which only
the 200 services threshold consideration exceeds. We believe that
setting a threshold of 200 services for the third criterion, combined
with our proposed policy for opting in to MIPS, strikes the appropriate
balance between allowing a significant number of eligible clinicians
the ability to opt-in (as described in this section) to MIPS and
consistency with the previously established low-volume threshold
criteria. In section VII.F.8.b. of this final rule, we estimated no
additional clinicians would be excluded if we add the third criterion
because a clinician that cares for at least 200 beneficiaries would
have at least 100 or 200 services; however, we estimate 27,903
clinicians would opt-in with the low-volume threshold at 200 services,
as compared to 12,242 clinicians if we did not add the third criterion.
If we set the third criterion at 100 services, then we estimate 32,828
clinicians would opt-in.
The following is a summary of the public comments received on our
proposals and our responses:
Comment: Many commenters supported the low-volume threshold
criteria and the newly proposed criterion based on number of covered
professional services. Many commenters noted this policy will reduce
burden, will help mitigate adverse effects on solo and small or rural
practices, and combined with the opt-in policy, allow practices to
transition into MIPS. Commenters specifically noted that the addition
of the third criteria and the proposed opt-in policy will permit
clinicians who are ready to participate if they had been previously
excluded. Several commenters also mentioned the newly proposed
criterion would increase the number of eligible clinicians that are
able to participate in MIPS.
Response: We appreciate the commenters' support.
Comment: One commenter noted concern that MIPS reporting
requirements may place significant financial, administrative, and
operational burdens on clinicians treating a low volume of Medicare
patients.
Response: It is important to note that clinicians who treat a low-
volume of Part B Medicare beneficiaries may be excluded from MIPS if
they fall below the low-volume threshold.
Comment: Many commenters opposed the low-volume threshold criteria
because they noted the thresholds for the individual criteria are too
high and excluded too many clinicians and added complexity. Many of
these commenters stated that the proposed low-volume threshold limits
the number of clinicians in the budget neutral pool and effectively
precludes MIPS eligible clinicians with good performance from earning
more than a nominal payment adjustment. Several commenters expressed
concern that eligible clinicians who make large financial commitments
and organizational infrastructure modifications to obtain designation
as exceptional performers would be adversely affected. A few commenters
noted that practices with these types of clinicians do not have large
compliance staff and other resources that larger groups have, and
therefore, it may be difficult for these clinicians to report and
navigate the program with short notice. Many commenters also stated the
proposed low-volume threshold would not move the Quality Payment
Program toward value and could jeopardize clinicians, particularly
those in small or rural practices, by leaving them unprepared should
they become MIPS eligible. One commenter expressed concerned that the
threshold could make it difficult to benchmark data because fewer
practices would be expected to participate in the program. One
commenter requested lowering the performance threshold to the $30,000
in Part B claims or 100 Part B patients threshold that we utilized for
2017 MIPS performance period or lowering the criteria for the opt-in
policy. A few commenters recommended that we consider revisiting the
low-volume thresholds to increase the percentage of clinicians that are
eligible.
Response: We believe that the proposed low-volume threshold strikes
the correct balance by including a sufficient number of clinicians,
while excluding those who are not quite ready to participate and need
additional time to prepare, such as clinicians in small and rural
practices. The addition of the third criterion for covered professional
services, in conjunction with the opt-in policy, creates a highly-
desired opportunity to join MIPS and provides new flexibility for
clinicians otherwise excluded to drive value and improve patient
outcomes when they are prepared to meaningfully participate. We have
heard feedback from many clinicians indicating the desire to
participate in MIPS. This feedback was especially prominent from
clinicians in small practices who were initially included in the 2017
performance year, but excluded in 2018 due to the increase in the low-
volume threshold. The addition of the third criterion for covered
professional services, in conjunction with the opt-in policy, provides
new flexibilities to participate in MIPS, which creates opportunities
for clinicians to drive value and improve patient outcomes. While we
understand that the inclusion of any new element may add complexity, we
believe that this enhancement will benefit both clinicians and
beneficiaries. We will work closely with the clinician and stakeholder
community to develop educational resources to help clarify the
requirements and reduce any potential confusion. Further, we do not
believe that the addition of the third criterion for covered
professional services will exclude more clinicians, as clinicians who
are currently treating over 200 beneficiaries would likely also be
furnishing over 200 covered professional services. As discussed, in
section III.I.3.j. of this final rule, we are finalizing our proposal
to increase the MIPS performance threshold to 30 points and the
exceptional performance bonus to 75 points in 2019. We believe that
this will likely result in an evolving distribution of payment
adjustments for high performing clinicians who have made the
investments to advance quality improvement, enhance clinical practice,
and improve outcomes for beneficiaries.
We understand that some MIPS eligible clinicians may work in small
group practices and may not have the same resources as a large group.
As discussed in the proposed rule (83 FR 35882) we intend to continue
to offer tailored flexibilities to help these clinicians to participate
in the program. For example, we are finalizing to retain a small
practice bonus under MIPS by moving it to the quality performance
category. We will also continue to

[[Page 59733]]

support small and rural practices by offering free and customized
resources available within local communities, including direct, one-on-
one support from the Small, Underserved, and Rural Support Initiative
along with our other no-cost technical assistance. Further, we note
that we are finalizing to amend our regulatory text to allow small
practices to continue using the Medicare Part B claims collection type
and submission types, either as an individual or as a group. Finally,
small practices may continue to choose to participate in MIPS as a
virtual group. In addition, we will continue offering the voluntary
reporting option, and encourage clinicians to pursue this pathway so
that they can familiarize themselves with the program requirements and
prepare to participate in future years. We clarify that for the first
several years of MIPS, which we view as transitional, we anticipate
that the distribution of MIPS payment adjustments will be spread across
many more clinicians and groups due to the moderate performance
thresholds and not necessarily because clinicians are excluded by the
low-volume threshold. For example, in 2017, the performance threshold
was set at 3 points, which resulted in an estimated participation rate
of 91 percent of MIPS eligible clinicians. As discussed in section
III.I.3.j. of this final rule, we are finalizing our proposal to
increase the MIPS performance threshold to 30 points and the
exceptional performance bonus to 75 points in 2019, which we anticipate
will likely result in an evolving distribution of payment adjustments
for high performing clinicians who have made the investments to advance
quality improvement, enhance clinical practice, and improve outcomes
for beneficiaries.
We do not believe that the total amount of dollars available for
the payment adjustments is low because too many clinicians are excluded
from the program. After incorporating the data submitted for the 2017
MIPS performance period (which we refer to as Quality Payment Program
Year 1 data) to estimate the CY 2021 MIPS payment year, an estimated
three-quarters (approximately $66.6B) of all PFS dollars will be
included in the CY 2021 MIPS payment year. Of the remaining one-quarter
(approximately $23.2B), only 2 percent (or less than 1 percent of total
PFS dollars) were associated with clinicians who did not meet the low-
volume threshold. The remaining clinicians excluded from the budget
neutral payment adjustments were Qualifying APM Participants,
clinicians with ineligible specialties, and newly enrolled clinicians
(11 percent of total PFS dollars). We considered the impact of lowering
the low-volume threshold to $30,000/100 beneficiaries/100 covered
professional services from the finalized low-volume threshold of this
final rule based on the budget neutrality distributions and the size of
the total payments. As seen in Figure 1, reducing the low-volume
threshold to $30,000/100 beneficiaries/100 covered professional
services) \16\ leads to an increase in the number of MIPS eligible
clinicians (by approximately 73,000 clinicians) and on the dollars
available in the budget neutral pool ($131M), but has minimal impact on
the maximum possible positive payment adjustment. The majority of
clinicians excluded from MIPS with the higher low-volume threshold are
clinicians in small practices with fewer than 15 clinicians. We
understand the importance of ensuring meaningful participation in the
program. We will continue to strike a balance between ensuring
sufficient participation in MIPS while also addressing the needs of
small practices that may find it difficult to meet the program
requirements.
---------------------------------------------------------------------------

\16\ The estimated values when the threshold is set to $30,000/
100 beneficiaries/100 covered professional services are not
reflective of actual MIPS results for the 2019 MIPS payment year.
There are slight differences in data sources and methods compared to
the 2019 MIPS payment year such as the low-volume threshold in this
model is based on covered PFS services and the model assumes a 33
percent opt-in assumption and uses the QP thresholds for the 2019 QP
performance period.

---------------------------------------------------------------------------

[[Page 59734]]

[GRAPHIC] [TIFF OMITTED] TR23NO18.043

Comment: One commenter encouraged us to continue reviewing the low-
volume threshold annually to ensure that the low-volume threshold
serves the purpose of excluding those for which the work of MIPS
reporting would outweigh the number of Medicare beneficiaries impacted.
A few commenters stated that the burden and cost of reporting for those
who do not exceed the low-volume threshold far exceeds any possible
benefit.
Response: We are committed to continuing program simplification and
burden reduction as we move into future years, including identifying
additional opportunities to help clinicians successfully participate.
We will continue to assess the low-volume threshold, as needed, to help
reduce burden for clinicians, especially those in small and rural
practices, who still find participation challenging. We believe that it
is important to implement the low-volume threshold in a way that
provides more time for clinicians to familiarize themselves with the
performance requirements under MIPS and, most importantly, prepare to
drive clinical quality improvement and improved outcomes for all
Medicare beneficiaries. We refer readers to the regulatory impact
analysis in section VII.F.8.b. of this final rule for further details
on the burden and cost of reporting.
Comment: A few commenters requested that we clarify how a covered
professional service would count when calculating the low-volume
threshold. Other commenters supported defining the concept of a covered
professional service as a single billing of a CPT code. One commenter
suggested 15-minute increments as the defining characteristic of a
professional service.
Response: For the CY 2018 and CY 2019 MIPS payment years, we have
utilized two calculations in order to make low-volume threshold
determinations: The number of patients and the amount of allowed
charges for each eligible clinician or group. These calculations were
based on the patients who were furnished any Part B item or service,
and on the allowed charges for all Part B items and services. Beginning
for the 2020 MIPS payment year, the calculations will instead be based
on covered professional services rather than all Part B items and
services.
Comment: One commenter requested clarification on the definition of
allowed charges for the low-volume threshold. The commenter asked if
allowed charges is equivalent to the full PFS amount or the PFS amount
minus the 20 percent co-pay. The commenter also asked about the
applicable Multiple Procedure Payment Reduction for a given session.
The commenter noted that each option would result in a different dollar
amount.
Response: In general, allowed charges refers to the maximum amount
Medicare will pay for a covered professional service under the PFS,
which is the PFS fee schedule amount reduced by the applicable
beneficiary co-payment. For purposes of MIPS low-volume threshold
determinations, allowed charges are calculated before any Multiple
Procedure Payment Reduction is applied. We refer readers to the CY 2018
Quality Payment Program final rule with comment period (82 FR 53578
through 53579) where we discuss the items and services to which the
MIPS payment adjustment could be applied under Part B.
Comment: A few commenters requested we outline a plan for the low-
volume threshold, such as a roadmap approach in which we propose and
adopt lower thresholds for several performance years at a time.

[[Page 59735]]

Additionally, the commenters requested that we describe if CMS has
plans to include currently excluded clinicians in the MIPS program in
the future. A few commenters asked for a report on the number of low-
volume clinicians that elect to be eligible and for us to use this
experience to modify the low-volume threshold criteria in future years
to move more clinicians into value-based programs.
Response: We agree that providing more clarity and stability into
the future of MIPS would be helpful and are interested in working with
stakeholders on what such future changes should look like. We are
working to provide as much consistency as possible for the low-volume
threshold while being flexible and considering changing needs. We note
that we are finalizing the low-volume threshold for the 2021 MIPS
payment year and future years, as well. Regarding a report on the
number of clinicians who are excluded due to the low-volume threshold
but elect to opt-in to MIPS, we will consider this suggestion for our
MIPS Experience Report.
After consideration of the public comments received, we are
finalizing our proposal to modify the definition of low-volume
threshold at Sec. 414.1305, to mean that for the 2021 MIPS payment
year and future years, that eligible clinicians or groups who meet at
least one of the following three criteria during the MIPS determination
period will not exceed the low-volume threshold: (1) Those who have
allowed charges for covered professional services less than or equal to
$90,000; (2) those who provide covered professional services to 200 or
fewer Part B-enrolled individuals; or (3) those who provide 200 or
fewer covered professional services to Part B-enrolled individuals.
(5) Low-Volume Threshold Opt-In
In the CY 2018 Quality Payment Program proposed rule (82 FR 30026),
we proposed the option to opt-in to MIPS participation if clinicians
might otherwise be excluded under the low-volume threshold. We received
general support from comments received on that final rule (82 FR
53589). However, we did not finalize the proposal for the 2019 MIPS
performance period at that time. We were concerned that we would not be
able to operationalize this policy in a low-burden manner to MIPS
eligible clinicians as it was proposed.
After consideration of operational and user experience implications
of an opt-in policy, we proposed an approach we believed could be
implemented in a way that provides the least burden to clinicians. As
discussed in the CY 2019 PFS proposed rule (83 FR 35887 through 35890),
we proposed to modify Sec. 414.1310(b)(1)(iii) to provide that
beginning with the 2021 MIPS payment year, if an eligible clinician or
group meets or exceeds at least one, but not all, of the low-volume
threshold determinations, including as defined by dollar amount (less
than or equal to $90,000) or number of beneficiaries (200 or fewer), or
number of covered professional services (200 or fewer), then such
eligible individual or group may choose to opt-in to MIPS.
This policy would apply to individual eligible clinicians and
groups who exceed at least one, but not all, of the low-volume
threshold criteria and would otherwise be excluded from MIPS
participation as a result of the low-volume threshold. We believed that
it would be beneficial to provide, to the extent feasible, such
individual eligible clinicians and groups with the ability to opt-in to
MIPS. Conversely, this policy would not apply to individual eligible
clinicians and groups who exceed all of the low-volume threshold
criteria, who unless otherwise excluded, are required to participate in
MIPS. In addition, this policy would not apply to individual eligible
clinicians and groups who do not exceed any of the low-volume threshold
criteria, who would be excluded from MIPS participation without the
ability to opt-in to MIPS. Although we believe we proposed the
appropriate balance for the low-volume threshold elements and the opt-
in policy, we requested comments on other low-volume threshold criteria
and supporting justification for the recommended criteria.
Under the proposed policies, we estimated clinician eligibility
based on the following (we refer readers to the regulatory impact
analysis in section VII.F.8.b. of this final rule for further details
on our assumptions): (1) Eligible because they exceed all three
criteria of the low-volume threshold and are not otherwise excluded
(estimated 770,000 based on our assumptions of who did individual and
group reporting); (2) eligible because they exceed at least one, but
not all, of the low-volume threshold criteria and elect to opt-in
(estimated 28,000 for a total MIPS eligible clinician population of
approximately 798,000); (3) potentially eligible if they either did
group reporting or elected to opt-in \17\ (estimated 390,000); (4)
excluded because they do not exceed any of the low-volume threshold
criteria (estimated 78,000); and (5) excluded due to non-eligible
specialty, newly enrolled, or QP status (estimated 209,000).
---------------------------------------------------------------------------

\17\ A clinician may be in a group that we estimated would not
elect group reporting, however, the group would exceed the low-
volume threshold on all three criteria if the group elected group
reporting. Similarly, an individual or group may exceed at least one
but not all of the low-volume threshold criteria, but we estimated
the clinician or group would not elect to opt-in to MIPS. In both
cases, these clinicians could be eligible for MIPS if the group or
individual makes choices that differ from our assumptions.
---------------------------------------------------------------------------

We proposed that applicable eligible clinicians who meet one or
two, but not all, of the criteria to opt-in and are interested in
participating in MIPS would be required to make a definitive choice to
either opt-in to participate in MIPS or choose to voluntarily report
before data submission (83 FR 35888). If they do not want to
participate in MIPS, they will not be required to do anything and will
be excluded from MIPS under the low-volume threshold. For those who do
want to participate in MIPS, we considered the option of allowing the
submission of data to signal that the clinician is choosing to
participate in MIPS. However, we anticipated that some clinicians who
utilize the quality data code (QDC) claims submission type may have
their systems coded to automatically append QDCs on claims for eligible
patients. We were concerned that they could submit a QDC code and
inadvertently opt-in when that was not their intention.
For individual eligible clinicians and groups to make an election
to opt-in or voluntarily report to MIPS, they will make an election via
the Quality Payment Program portal by logging into their account and
simply selecting either the option to opt-in (positive, neutral, or
negative MIPS adjustment) or to remain excluded and voluntarily report
(no MIPS adjustment). Once the eligible clinician has elected to
participate in MIPS, the decision to opt-in to MIPS will be irrevocable
and cannot be changed for the applicable performance period. Clinicians
who opt-in will be subject to the MIPS payment adjustment during the
applicable MIPS payment year. Clinicians who do not decide to opt-in to
MIPS will remain excluded and may choose to voluntarily report. Such
clinicians will not receive a MIPS payment adjustment factor. To assist
commenters in providing pertinent comments, we developed a website that
provided design examples of the different approaches to MIPS
participation in CY 2019. The website utilized wireframe (schematic)
drawings to illustrate the three different approaches to MIPS
participation: Voluntary reporting to MIPS, opt-in reporting to MIPS,
and required to

[[Page 59736]]

participate in MIPS. The website provided specific matrices
illustrating potential stakeholder experiences when opting-in or
voluntarily reporting.
The option to opt-in to participate in the MIPS as a result of an
individual eligible clinician or group exceeding at least one, but not
all, of the low-volume threshold elements differs from the option to
voluntarily report to the MIPS as established at Sec. 414.1310(b)(2)
and (d). Individual eligible clinicians and groups opting-in to
participate in MIPS will be considered MIPS eligible clinicians, and
therefore subject to the MIPS payment adjustment factor; whereas,
individual eligible clinicians and groups voluntarily reporting
measures and activities for the MIPS are not considered MIPS eligible
clinicians, and therefore not subject to the MIPS payment adjustment
factor. MIPS eligible clinicians and groups that made an election to
opt-in will be able to participate in MIPS at the individual, group, or
virtual group level for that performance period. Eligible clinicians
and groups that are excluded from MIPS, but voluntarily report, are
able to report measures and activities at the individual or group
level; however, such eligible clinicians and groups are not able to
voluntarily report for MIPS at the virtual group level.
In Table 31, we provided possible scenarios regarding which
eligible clinicians may be able to opt-in to MIPS depending upon their
beneficiary count, dollars, and covered professional services if the
proposed opt-in policy was finalized.

Table 31--Low-Volume Threshold Determination Opt-In Scenarios
----------------------------------------------------------------------------------------------------------------
Covered
Beneficiaries Dollars professional Eligible for opt-in
services
----------------------------------------------------------------------------------------------------------------
<=200......................................... <=90K <=200 Excluded not eligible to Opt-in.
<=200......................................... <=90K >200 Eligible to Opt-in, Voluntarily
Report, or Not Participate.
<=200......................................... >90K <=200 Eligible to Opt-in, Voluntarily
Report, or Not Participate.
>200.......................................... <=90K >200 Eligible to Opt-in, Voluntarily
Report, or Not Participate.
>200.......................................... >90K >200 Not eligible to Opt-in, Required
to Participate.
----------------------------------------------------------------------------------------------------------------

We recognize that the low-volume threshold opt-in option may expand
MIPS participation at the individual, group, and virtual group levels.
For solo practitioners and groups with 10 or fewer eligible clinicians
(including at least one MIPS eligible clinician) that exceed at least
one, but not all, of the elements of the low-volume threshold and are
interested in participating in MIPS via the opt-in and doing so as part
of a virtual group, such solo practitioners and groups will need to
make an election to opt-in to participate in the MIPS. Therefore,
beginning with the 2021 MIPS payment year, we proposed that a virtual
group election would constitute a low-volume threshold opt-in for any
prospective member of the virtual group (solo practitioner or group)
that exceeds at least one, but not all, of the low-volume threshold
criteria. As a result of the virtual group election, any such solo
practitioner or group will be treated as a MIPS eligible clinician for
the applicable MIPS payment year.
During the virtual group election process, the official virtual
group representative of a virtual group submits an election to
participate in the MIPS as a virtual group to CMS prior to the start of
a performance period (82 FR 53601 through 53604). The submission of a
virtual group election includes TIN and NPI information, which is the
identification of TINs composing the virtual group and each member of
the virtual group. As part of a virtual group election, the virtual
group representative is required to confirm through acknowledgement
that a formal written agreement is in place between each member of the
virtual group (82 FR 53604). A virtual group may not include a solo
practitioner or group as part of a virtual group unless an authorized
person of the TIN has executed a formal written agreement.
For a solo practitioner or group that exceeds only one or two
elements of the low-volume threshold, an election to opt-in to
participate in the MIPS as part of a virtual group would be represented
by being identified as a TIN that is included in the submission of a
virtual group election. Such solo practitioners and groups opting-in to
participate in the MIPS as part of a virtual group would not need to
independently make a separate election to opt-in to participate in the
MIPS. We note that being identified as a TIN in a submitted virtual
group election, any such TIN (represented as a solo practitioner or
group) that exceeds at least one, but not all, of the low-volume
threshold elements during the MIPS determination period is signifying
an election to opt-in to participate in MIPS as part of a virtual group
and recognizing that a MIPS payment adjustment factor would be applied
to any such TIN based on the final score of the virtual group. For a
virtual group election that includes a TIN determined to exceed at
least one, but not all, of the low-volume threshold elements during the
MIPS determination period, such election would have a precedence over
the eligibility determination made during the MIPS determination period
pertaining to the low-volume threshold and as a result, any such TIN
would be considered MIPS eligible and subject to a MIPS payment
adjustment factor due the virtual group election. Furthermore, we note
that a virtual group election would constitute an election to opt-in to
participate in MIPS and any low-volume threshold determinations that
result from segment 2 data analysis of the MIPS determination period
would not have any bearing on the virtual group election. Thus, a TIN
included as part of a virtual group election that submitted prior to
the start of the applicable performance period and does not exceed at
least one element of the low-volume threshold during segment 2 of the
MIPS determination period, such TIN would be considered MIPS eligible
and a virtual group participant by virtue of the virtual group's
election to participate in MIPS as a virtual group that was made prior
to the applicable performance period. For virtual groups with a
composition that may only consist of solo practitioners and groups that
exceed at least one, but not all of the low-volume threshold elements,
such virtual groups are encouraged to form a virtual group that would
include a sufficient number of TINs to ensure that such virtual groups
are able to meet program requirements such as case minimum criteria
that would allow measures to be scored. For example, if a virtual group
does not have a sufficient number of cases to report for quality
measures (minimum of 20 cases per measures), a virtual group would

[[Page 59737]]

not be scored on such measures (81 FR 77175).
We further noted that APM Entities in MIPS APMs, which meet one or
two, but not all, of the low-volume threshold elements to opt-in and
are interested in participating in MIPS under the APM scoring standard,
would be required to make a definitive choice at the APM Entity level
to opt-in to participate in MIPS. For such APM Entities to make an
election to opt-in to MIPS, they would make an election via a similar
process that individual eligible clinicians and groups will use to make
an election to opt-in. Once the APM Entity has elected to participate
in MIPS, the decision to opt-in to MIPS is irrevocable and cannot be
changed for the performance period in which the data was submitted.
Eligible clinicians in APM Entities in MIPS APMs that opt-in would be
subject to the MIPS payment adjustment factor. APM Entities in MIPS
APMs that do not decided to opt-in to MIPS cannot voluntarily report.
Additionally, we proposed for applicable eligible clinicians
participating in a MIPS APM, whose APM Entity meets one or two, but not
all, of the low-volume threshold elements rendering the option to opt-
in and does not decide to opt-in to MIPS, that if their TIN or virtual
group does elect to opt-in, it does not mean that the eligible
clinician is opting-in on his/her own behalf, or on behalf of the APM
Entity, but that the eligible clinician is still excluded from MIPS
participation as part of the APM Entity even though such eligible
clinician is part of a TIN or virtual group. This is necessary because
low-volume threshold determinations are currently conducted at the APM
Entity level for all applicable eligible clinicians in MIPS APMs, and
therefore, the low-volume threshold opt-in option should similarly be
executed at the APM Entity level rather than at the individual eligible
clinician, TIN, or virtual group level. Thus, in order for an APM
Entity to opt-in to participate in MIPS at the APM Entity level and for
eligible clinicians within such APM Entity to be subject to the MIPS
payment adjustment factor, an election would need to be made at the APM
Entity level in a similar process that individual eligible clinicians
and groups would use to make an election to opt-in to participate in
MIPS.
We requested comments on our proposals: (1) To modify Sec.
414.1305 for the low-volume threshold definition at paragraph (3) to
specify that, beginning with the 2021 MIPS payment year, the low-volume
threshold that applies to an individual eligible clinician or group
that, during the MIPS determination period, has allowed charges for
covered professional services less than or equal to $90,000, furnishes
covered professional services to 200 or fewer Medicare Part B-enrolled
individuals, or furnishes 200 or fewer covered professional services to
Medicare Part B-enrolled individuals; (2) that a clinician who is
eligible to opt-in would be required to make an affirmative election to
opt-in to participate in MIPS, elect to be a voluntary reporter, or by
not submitting any data the clinician is choosing to not report; and
(3) to modify Sec. 414.1310(b)(1)(iii) under Applicability to specify
exclusions as follows: Beginning with the 2021 MIPS payment year, if an
individual eligible clinician, group, or APM Entity group in a MIPS APM
exceeds at least one, but not all, of the low-volume threshold criteria
and elects to report on applicable measures and activities under MIPS,
the individual eligible clinician, group, or APM Entity group is
treated as a MIPS eligible clinician for the applicable MIPS payment
year. For APM Entity groups in MIPS APMs, only the APM Entity group
election can result in the APM Entity group being treated as MIPS
eligible clinicians for the applicable payment year.
The following is a summary of the public comments received on our
proposals and our responses:
Comment: Many commenters supported the opt-in policy as proposed.
Many commenters supported that clinicians electing to opt-in may have
either a negative or positive payment adjustment. One commenter stated
the opportunity for clinicians to opt-in to MIPS will help to offset
the additional exclusions resulting from the addition of a third low-
volume criterion. A few commenters noted the opt-in provides a
participation opportunity for clinicians who bill low-cost services and
would not otherwise exceed the low-volume threshold based on allowed
charges. Other commenters noted that MIPS is the only way for MIPS
eligible clinicians to earn a meaningful MIPS payment adjustment factor
and opt-in is the only way for eligible clinicians who do not exceed
the low-volume threshold to participate. Many commenters noted the
policy provides flexibility and may encourage those clinicians who are
not ready to have their payment affected by MIPS performance to test
their ability to gather and submit performance data and gain experience
with MIPS.
Response: We appreciate the commenters' support. We note that if an
eligible clinician chooses to opt-in to MIPS then they will be subject
to the MIPS payment adjustment during the applicable MIPS payment year.
If a clinician is eligible to opt-in but does not want to participate
in MIPS, and be subject to the MIPS payment adjustment, then we would
encourage clinicians to voluntarily report.
Comment: Many commenters opposed the opt-in policy. A few
commenters noted concern that the opt-in will reduce incentives to
participate in MIPS, with one specifically stating it does not align
with the agency's stated goal for MIPS to be a pathway to eventual
participation in APMs. Some commenters also noted concern with how the
opt-in may affect the overall scores, stating that (1) the additional
clinicians who voluntarily opt-in are likely to be above the MIPS
threshold, and therefore may reduce the amount of positive MIPS payment
adjustment factors for clinicians who are required to participate, (2)
the opt-in will likely continue to flatten the clinician's final score,
lowering the overall aggregate increase, and (3) if too many eligible
clinicians are excluded, positive payment adjustments would be
insufficient to help offset the investments practices health systems
must make to succeed under MIPS. Another commenter stated that CMS
should identify a core set of data on MIPS and its various exclusions
to be updated annually in conjunction with the proposed rule to allow
stakeholders to follow the impacts of those exclusions longitudinally.
Response: While we encourage clinicians who are excluded to opt-in
to the program once they are prepared to meaningfully participate as a
means of driving value and improving outcomes for more Medicare
beneficiaries, we believe that the opt-in policy does not undermine APM
participation or the transition of clinicians from MIPS to APMs because
the opt-in policy is applied at the APM Entity level for clinicians and
groups participating in APMs. For this final rule, we analyzed the
impact of the opt-in policy by running models which incorporate the
Quality Payment Program Year 1 submissions data. The models include
eligibility without opt-in, opt-in based on a random sample of 33
percent of clinicians who can elect to opt-in, and opt-in where only
high performers (that is, clinicians who can anticipate a positive
adjustment) elect to opt-in. To model the situation where only high
performers would opt-in to MIPS, we assumed 100 percent of clinicians
with final scores above the additional performance threshold would opt-
in and 50 percent of clinicians above the performance threshold but
below the additional performance threshold would

[[Page 59738]]

opt-in. We observed a very modest impact to the payment adjustment
irrespective of the opt-in assumption used. Please see Figure 2 for the
model by opt-in assumption. Lastly, we appreciate the request for
additional core data to be made available, we will continue to work
with stakeholders to identify the information that is valuable and
release it accordingly.
Comment: Many commenters supported an opt-in policy, but believed
the policy should be available to more clinicians. Of these commenters,
most believed that the opt-in should be available even if the clinician
did not exceed any of the low-volume criteria. A few commenters
indicated that MIPS should be voluntary for all clinicians. One
commenter requested that we make the opt-in policy retroactive to the
MIPS 2018 performance period for year-to-year consistency,
simplification, and to improve overall participation. Another commenter
stated that the clinicians who switch practices in the last three
months of MIPS performance period should be able to opt-in.
Response: We do not believe that we have the flexibility to allow
any clinician who wishes to participate in MIPS to opt-in nor to
retroactively apply the opt-in policy to the 2018 MIPS performance
period. Finally, as discussed in the section III.I.3.b. of this final
rule, during the final 3 months of the calendar year in which the
performance period occurs, in general, we do not believe it would be
feasible for many MIPS eligible clinicians who join an existing
practice (existing TIN) or join a newly formed practice (new TIN) to
participate in MIPS as individuals. To clarify if an eligible clinician
switches to an existing TIN or a new TIN they may be able to
participate in MIPS as a group. However, they would not be able to
participate as an individual.
Comment: Several commenters supported the proposal that eligible
clinicians who are eligible to opt-in would be required to make an
affirmative election to opt-in to participate in MIPS. One commenter
agreed that an affirmative election to report is necessary to avoid
confusion and possible inadvertent claims submissions that might
involuntarily opt-in a clinician to MIPS.
Response: We agree that even eligible clinicians submitting MIPS
data via claims must make an affirmative election.
Comment: Several commenters sought clarification on the deadline to
opt-in. A few commenters wondered if clinicians can choose to wait
until the data submission deadline for a performance year, or whether
they must elect to opt-in sooner than that. One commenter recommended
that clinicians should have a deadline of no later than the last day in
the month of February, or perhaps the 15th of March, for the
performance period in which they intend to participate. This commenter
stated that allowing the choice to opt-in at any point during the
performance period will only increase participatory rates among
clinicians or groups who have knowledge of favorable outcomes and will
excuse those whose outcomes were undesirable. One commenter encouraged
us to allow clinicians to opt-in at the time of data submission, as
this would create the least amount of burden on clinicians who wish to
opt-into the program. Another commenter urged us to allow an opt-in
decision at any point during the data submission window and to provide
confirmation of the decision to opt-in. Another commenter stated that
we should not make the opt-in decision irrevocable.
Response: We would like to create a process for eligible clinicians
who wish to opt-in to MIPS that is the least burdensome but also
provides the clinician with the most flexibility. We are exploring if
we can operationally allow clinicians to opt-in at any time prior to
the submission period and will provide further guidance via
subregulatory guidance if this becomes available. We are finalizing at
Sec. 414.1310(b)(1)(iii) under Applicability to specify exclusions as
follows: Beginning with the 2021 MIPS payment year, if an individual
eligible clinician, group, or APM Entity group in a MIPS APM exceeds at
least one, but not all, of the low-volume threshold criteria and elects
to report on applicable measures and activities under MIPS, the
individual eligible clinician, group, or APM Entity group is treated as
a MIPS eligible clinician for the applicable MIPS payment year. We
agree that allowing clinicians the choice to opt-in at any point during
the performance period may increase the potential that only high
performers will opt-in, but we believe that this policy accounts for
clinicians who identified in the second segment of the MIPS
determination period. Also, we plan to monitor this issue and will
address it through future rulemaking if necessary. Finally, regarding
the opt-in decision being irrevocable, we believe it is necessary for
the clinician to make a definitive decision regarding their
participation in MIPS. If the decision to opt-in was not definitive
then we believe the potential for a clinician to have an unfair
advantage is increased by their ability to review their final feedback
and scoring information available at submissions and subsequently alter
their participation decision.
Comment: One commenter noted that with the manual election to
indicate opt-in, the need for a low-volume threshold criterion based on
professional services should not make a difference in a clinician's
ability to opt-in. Other commenters opposed the requirement for the
eligible clinician to manually opt-in, noting that it would add
administrative burden. Another commenter stated that it is unnecessary
to create a MIPS opt-in policy for some low-volume clinicians as they
may not meet the case minimums for measures.
Response: We do not believe that the manual election to opt-in has
relevance to the clinician's covered professional services. We are
providing the third criterion of covered professional services to
expand the number of clinicians eligible to opt-in to the program.
Regarding the manual election to opt-in, we believe this is the least
burdensome approach to ensuring that clinicians are making an informed
decision regarding their MIPS participation. We believe that most MIPS
eligible clinicians that provide at least 200 covered professional
service will be able to meet the case minimums for measures.
Comment: A few commenters requested additional clarification on the
implication of the opt-in policy on the MIPS payment adjustment and on
how we estimated the number of opt-in clinicians.
Response: We described our approach to estimating the opt-in policy
in the regulatory impact analysis of the CY 2019 PFS proposed rule (83
FR 36057 through 36068). We sought comment on this approach and refer
readers to the Regulatory Impact Analysis (RIA) in section VII. of this
final rule for additional information. The RIA for this final rule
examined the impact of the opt-in policy on payment adjustments by
using two alternate opt-in assumptions: (1) If only clinicians with
scores above the performance threshold opt-in (the actual opt-in is
likely to be lower than this estimated number of clinicians opting-in);
and (2) if none of the clinicians elected to opt-in. See Figure 2 for a
summary of the results. As shown in Figure 2, the opt-in policy was
found to have a small impact on the budget neutral pool when we assumed
a random 33 percent of clinicians would opt-in irrespective of their
performance and a minimal impact on payment adjustments regardless of
the opt-in assumption used. Given these findings, we chose to use the
33 percent opt-in

[[Page 59739]]

assumption for all CY 2019 performance period estimates.
[GRAPHIC] [TIFF OMITTED] TR23NO18.044

Comment: A few commenters supported the proposal to only allow APM
entities to opt-in as a group. One commenter urged us to explain in-
depth the application of the low-volume threshold opt-in option for
MIPS APM TINs.
Response: We explained the application of the low-volume threshold
for APM Entities in MIPS APMs in detail in the CY 2019 PFS proposed
rule (83 FR 35889) and refer readers to that discussion.
Comment: One commenter did not agree that performance category data
submitted by a third party intermediary needed a separate opt-in
election. The commenter stated that in these instances, the clinician
or group has chosen to engage a third party intermediary for MIPS
reporting which the commenter believed is an affirmative event
demonstrating intent to participate in the MIPS program. The commenter
also noted that for clinicians or small-groups submitting quality data
via QDC codes on claims, if those clinicians and/or small groups also
submit any category data via a third-party intermediary, the Quality
Payment Program portal, or the CMS Web Interface, that should be
considered as an opt-in decision. One commenter requested that we
provide a technical interface/API which allows clinicians and groups to
opt-in through the service of third party intermediaries.
Response: We want to ensure that clinicians are making an informed
decision regarding opting-in to participate in MIPS. It is imperative
that they make a definitive decision since clinicians who opt-in will
be subject to the MIPS payment adjustment during the applicable MIPS
payment year. We believe that an election to opt-in to MIPS must be
made by the clinician or group through a definitive opt-in decision to
participate in MIPS regardless of the way in which the data is
submitted. In addition, in response to public comments, in instances
where a third party intermediary is representing a MIPS eligible
clinician, the third party intermediary must be able to transmit the
clinician's opt-in decision to CMS. We refer readers to section
III.I.3.k. of this final rule for more information regarding third
party intermediary requirements.
Comment: A few commenters requested information for clinicians and
groups to make an informed choice about the opt-in. One commenter urged
us to make it clear as to whether a clinician and group is eligible to
opt-in to MIPS, what this decision could mean in terms of reducing or
increasing their Medicare payments, and when the decision would be
final. A few commenters requested the eligibility information prior to
the start of the performance period, so that MIPS eligible clinicians
and groups who want to opt-in to MIPS have the information necessary to
make an informed choice about their participation options. Other
commenters requested information on how the two MIPS determination
periods work with the opt-in policy.
Response: We understand that it is important for clinicians to know
their eligibility status prior to the performance period. We are
working to provide quarterly snapshots, if feasible. We believe these
quarterly snapshots will provide important information to clinicians so
that they may make informed decisions regarding whether they should
opt-in to participate in MIPS. It is important to note that the
quarterly snapshots are being provided for informational use only and
not final until after the second segment of the MIPS determination
period closes (which is September 30 of the calendar year in which the
applicable performance period occurs) and a reconciliation occurs.
Since the quarterly snapshots are not final this information is subject
to change and should not be considered the final eligibility
determination. The eligibility determination will be made after a
reconciliation of the first and second segment of the MIPS
determination period. We are finalizing at Sec. 414.1310(b)(1)(iii)
under Applicability to specify exclusions that include, beginning with
the 2021 MIPS payment year, if an individual eligible clinician, group,
or APM Entity group in a MIPS APM exceeds at least one, but not all,

[[Page 59740]]

of the low-volume threshold criteria and elects to report on applicable
measures and activities under MIPS, the individual eligible clinician,
group, or APM Entity group is treated as a MIPS eligible clinician for
the applicable MIPS payment year.
Comment: One commenter recommended that we change the name of the
voluntary participation option to ensure that clinicians do not confuse
that option with opt-in participation. Since a voluntary participant is
only reporting data, they suggested changing that category to Voluntary
Reporting to ensure this is not confused with opt-in Participation.
Response: We agree and are modifying the participation terms on the
Quality Payment Program website to provide clear directions. Therefore,
we note that when clinicians are reporting for MIPS they may enter the
Quality Payment Program portal to choose the appropriate MIPS
participation. For those eligible clinicians or groups who exceed all
three criteria of the low-volume threshold their participation will be
automatically selected as they are required to participate. For
individual eligible clinicians and groups who are qualified they may
make an election to by choosing to either: Agree to opt-in
participation or to voluntarily report to MIPS, the clinician would
make an election via the Quality Payment Program portal by logging into
their account and simply selecting either the option to opt-in
participation (positive, neutral, or negative MIPS adjustment) or to
remain excluded and voluntarily report (no MIPS adjustment). So the
three options when reporting data through the Quality Payment Program
portal are: Voluntary reporting, opt-in participation, and required to
participate in MIPS. We referred readers to the Quality Payment Program
at qpp.cms.gov/design-examples to review the finalized wireframe
drawings.
After consideration of the public comments received, we are
finalizing our proposals: (1) To modify Sec. 414.1305 for the low-
volume threshold definition at paragraph (3) to specify that, beginning
with the 2021 MIPS payment year, the low-volume threshold that applies
to an individual eligible clinician, group, or APM Entity group that,
during the MIPS determination period, has allowed charges for covered
professional services less than or equal to $90,000, furnishes covered
professional services to 200 or fewer Medicare Part B-enrolled
individuals, or furnishes 200 or fewer covered professional services to
Medicare Part B-enrolled individuals; (2) that a clinician who is
eligible to opt-in would be required to make an affirmative election to
opt-in to participate in MIPS, elect to be a voluntary reporter, or by
not submitting any data the clinician is choosing to not report; and
(3) to modify Sec. 414.1310(b)(1)(iii) under Applicability to specify
exclusions as follows: Beginning with the 2021 MIPS payment year, if an
individual eligible clinician, group, or APM Entity group in a MIPS APM
exceeds at least one, but not all, of the low-volume threshold criteria
and elects to report on applicable measures and activities under MIPS,
the individual eligible clinician, group, or APM Entity group is
treated as a MIPS eligible clinician for the applicable MIPS payment
year. For such solo practitioners and groups that elect to participate
in MIPS as a virtual group (except for APM Entity groups in MIPS APMs),
the virtual group election under Sec. 414.1315 constitutes an election
under this paragraph and results in the solo practitioners and groups
being treated as MIPS eligible clinicians for the applicable MIPS
payment year. For such APM Entity groups in MIPS APMs, only the APM
Entity group election can constitute an election under this paragraph
and result in the APM Entity group being treated as MIPS eligible
clinicians for the applicable MIPS payment year. We note that a virtual
group election does not constitute a Partial QP election under revised
Sec. 414.1310(b)(1)(ii). In order for an individual eligible clinician
or APM Entity with a Partial QP status to explicitly elect to
participate in MIPS and be subject to the MIPS payment adjustment
factor, such individual eligible clinician or APM Entity would make
such election during the applicable performance period as a Partial QP
status becomes applicable and such option for election is warranted.
(6) Part B Services Subject to MIPS Payment Adjustment
Section 1848(q)(6)(E) of the Act, as amended by section
51003(a)(1)(E) of the Bipartisan Budget Act of 2018, provides that the
MIPS adjustment factor and, as applicable, the additional MIPS
adjustment factor, apply to the amount otherwise paid under Part B with
respect to covered professional services (as defined in subsection
(k)(3)(A) of the Act) furnished by a MIPS eligible clinician during a
year (beginning with 2019) and with respect to the MIPS eligible
clinician for such year.
In the CY 2019 PFS proposed rule (83 FR 35890), we requested
comments on our proposal to amend Sec. 414.1405(e) to modify the
application of both the MIPS adjustment factor and, if applicable, the
additional MIPS adjustment factor so that beginning with the 2019 MIPS
payment year, these adjustment factors will apply to Part B payments
for covered professional services (as defined in section 1848(k)(3)(A)
of the Act) furnished by the MIPS eligible clinician during the year.
We are making this change beginning with the first MIPS payment year
and note that these adjustment factors will not apply to Part B drugs
and other items furnished by a MIPS eligible clinician, but will apply
to covered professional services furnished by a MIPS eligible
clinician. We refer readers to section III.I.3.j. of this final rule
for further details on this modification.
The following is a summary of the public comments received on our
proposals and our responses:
Comment: One commenter stated that they support the technical
amendment made by Congress in the Bipartisan Budget Act of 2018 to
clarify that items or services beyond the PFS, especially Part B drugs,
should not be included when determining MIPS eligibility and applying
the MIPS payment adjustment.
Response: We appreciate the commenters' support.
After consideration of the public comments received, we are
finalizing our proposal to amend Sec. 414.1405(e) to modify the
application of both the MIPS adjustment factor and, if applicable, the
additional MIPS adjustment factor so that beginning with the 2019 MIPS
payment year, these adjustment factors will apply to Part B payments
for covered professional services (as defined in section 1848(k)(3)(A)
of the Act) furnished by the MIPS eligible clinician during the year.
We are making this change beginning with the first MIPS payment year
and note that these adjustment factors will not apply to Part B drugs
and other items furnished by a MIPS eligible clinician, but will apply
to covered professional services furnished by a MIPS eligible
clinician.
d. Partial QPs
(1) Partial QP Elections Within Virtual Groups
In the CY 2017 Quality Payment Program final rule, we finalized
that following a determination that eligible clinicians in an APM
Entity group in an Advanced APM are Partial QPs for a year, the APM
Entity will make an election whether to report on applicable measures
and activities as required under MIPS. If the APM Entity elects to
report to MIPS, all eligible clinicians in

[[Page 59741]]

the APM Entity would be subject to the MIPS reporting requirements and
payment adjustments for the relevant year. If the APM Entity elects not
to report, all eligible clinicians in the APM Entity group will be
excluded from the MIPS reporting requirements and payment adjustments
for the relevant year (81 FR 77449).
We also finalized that in cases where the Partial QP determination
is made at the individual eligible clinician level, if the individual
eligible clinician is determined to be a Partial QP, the eligible
clinician will make the election whether to report on applicable
measures and activities as required under MIPS and, as a result, be
subject to the MIPS reporting requirements and payment adjustments (81
FR 77449). If the individual eligible clinician elects to report to
MIPS, he or she would be subject to the MIPS reporting requirements and
payment adjustments for the relevant year. If the individual eligible
elects not to report to MIPS, he or she will be excluded from the MIPS
reporting requirements and payment adjustments for the relevant year.
We also clarified how we consider the absence of an explicit
election to report to MIPS or to be excluded from MIPS. We finalized
that for situations in which the APM Entity is responsible for making
the decision on behalf of all eligible clinicians in the APM Entity
group, the group of Partial QPs will not be considered MIPS eligible
clinicians unless the APM Entity opts the group into MIPS
participation, so that no actions other than the APM Entity's election
for the group to participate in MIPS would result in MIPS participation
(81 FR 77449). For eligible clinicians who are determined to be Partial
QPs individually, we finalized that we will use the eligible
clinician's actual MIPS reporting activity to determine whether to
exclude the Partial QP from MIPS in the absence of an explicit
election. Therefore, if an eligible clinician who is individually
determined to be a Partial QP submits information to MIPS (not
including information automatically populated or calculated by CMS on
the Partial QP's behalf), we will consider the Partial QP to have
reported, and thus to be participating in MIPS. Likewise, if such an
individual does not take any action to submit information to MIPS, we
will consider the Partial QP to have elected to be excluded from MIPS
(81 FR 77449).
In the CY 2018 Quality Payment Program final rule, we clarified
that in the case of an eligible clinician participating in both a
virtual group and an Advanced APM who has achieved Partial QP status,
that the eligible clinician would be excluded from the MIPS payment
adjustment unless the eligible clinician elects to report under MIPS
(82 FR 53615). As discussed in the CY 2019 PFS proposed rule (83 FR
35890 through 35891), we incorrectly stated that affirmatively agreeing
to participate in MIPS as part of a virtual group prior to the start of
the applicable performance period would constitute an explicit election
to report under MIPS for all Partial QPs. As such, we also incorrectly
stated that all eligible clinicians who participate in a virtual group
and achieve Partial QP status would remain subject to the MIPS payment
adjustment due to their virtual group election to report under MIPS,
regardless of their Partial QP election. We note that an election made
prior to the start of an applicable performance period to participate
in MIPS as part of a virtual group is separate from an election made
during the performance period that is warranted as a result of an
individual eligible clinician or APM Entity achieving Partial QP status
during the applicable performance period. A virtual group election does
not equate to an individual eligible clinician or APM Entity with a
Partial QP status explicitly electing to participate in MIPS. In order
for an individual eligible clinician or APM Entity with a Partial QP
status to explicitly elect to participate in MIPS and be subject to the
MIPS payment adjustment factor, such individual eligible clinician or
APM Entity would make such election during the applicable performance
period as a Partial QP status becomes applicable and such option for
election is warranted. Thus, we are restating that affirmatively
agreeing to participate in MIPS as part of a virtual group prior to the
start of the applicable performance period does not constitute an
explicit election to report under MIPS as it pertains to making an
explicit election to either report to MIPS or be excluded from MIPS for
individual eligible clinicians or APM Entities that have Partial QP
status.
Related to this clarification, we are finalizing in section
III.I.4.e.(3) of this final rule to clarify that beginning with the
2021 MIPS payment year, when an eligible clinician is determined to be
a Partial QP for a year at the individual eligible clinician level, the
individual eligible clinician has the option to make an election
whether to report to MIPS. If the eligible clinician elects to report
to MIPS, he or she will be subject to MIPS reporting requirements and
payment adjustments. If the eligible clinician elects to not report to
MIPS, he or she will not be subject to MIPS reporting requirements and
payment adjustments. If the eligible clinician does not make any
affirmatively election to report to MIPS, he or she will not be subject
to MIPS reporting requirements and payment adjustments. As a result,
beginning with the 2021 MIPS payment year, for eligible clinicians who
are determined to be Partial QPs individually, we will not use the
eligible clinician's actual MIPS reporting activity to determine
whether to exclude the Partial QP from MIPS in the absence of an
explicit election.
Therefore, the finalized policy in section III.I.4.e.(3) of this
final rule eliminates the scenario in which affirmatively agreeing to
participate in MIPS as part of a virtual group prior to the start of
the applicable performance period will constitute an explicit election
to report under MIPS for eligible clinicians who are determined to be
Partial QPs individually and make no explicit election to either report
to MIPS or be excluded from MIPS. We believe this change is necessary
because QP status and Partial QP status, achieved at the APM Entity
level or eligible clinician level, is applied to an individual and all
of his or her TIN/NPI combinations, whereas virtual group participation
is determined at the TIN level. Therefore, we do not believe that it is
appropriate that the actions of the TIN in joining the virtual group
should deprive the eligible clinician who is a Partial QP, whether that
status was achieved at APM Entity level or eligible clinician level, of
the opportunity to elect whether or not to opt-in to MIPS.
e. Group Reporting
We refer readers to Sec. 414.1310(e) and the CY 2018 Quality
Payment Program final rule (82 FR 53592 through 53593) for a
description of our previously established policies regarding group
reporting.
In the CY 2018 Quality Payment Program final rule (82 FR 53593), we
clarified that we consider a group to be either an entire single TIN or
portion of a TIN that: (1) Is participating in MIPS according to the
generally applicable scoring criteria while the remaining portion of
the TIN is participating in a MIPS APM or an Advanced APM according to
the MIPS APM scoring standard; and (2) chooses to participate in MIPS
at the group level. We further clarify that we consider a group to be
an entire single TIN that chooses to participate in MIPS at the group
level. However, individual eligible clinicians (TIN/NPIs) within that
group may receive a MIPS payment adjustment

[[Page 59742]]

based on the APM scoring standard if they are on the participant list
of a MIPS APM. We proposed to amend Sec. Sec. 414.1310(e) and
414.1370(f)(2) to codify this policy and more fully reflect the scoring
hierarchy as discussed in section III.I.3.h.(6) of this final rule.
As discussed in the CY 2018 Quality Payment Program final rule (82
FR 53593), one of the overarching themes we have heard from
stakeholders is that we make an option available to groups that would
allow a portion of a group to report as a separate sub-group on
measures and activities that are more applicable to the sub-group and
be assessed and scored accordingly based on the performance of the sub-
group. We stated that in future rulemaking, we intend to explore the
feasibility of establishing group-related policies that would permit
participation in MIPS at a sub-group level and create such
functionality through a new identifier. In the CY 2018 Quality Payment
Program proposed rule (82 FR 30027), we solicited public comments on
the ways in which participation in MIPS at the sub-group level could be
established. In addition, in the CY 2018 Quality Payment Program final
rule (82 FR 53593), we sought comment on additional ways to define a
group, not solely based on a TIN. Because there are several operational
challenges with implementing a sub-group option, we did not propose any
such changes to our established reporting policies in this final rule.
Rather, we are considering facilitating the use of a sub-group
identifier in the Quality Payment Program Year 4 through future
rulemaking, as necessary. In addition, it has come to our attention
that providing a sub-group option may provide potential gaming
opportunities. For example, a group could manipulate scoring by
creating sub-groups that are comprised of only the high performing
clinicians in the group. Therefore, we requested comment on
implementing sub-group level reporting through a separate sub-group
sub-identifier in the Quality Payment Program Year 4 and possibly
future years of the program.
In the CY 2019 PFS proposed rule (83 FR 35891) we requested
comments on the following: (1) Whether and how a sub-group should be
treated as a separate group from the primary group: For example, if
there is 1 sub-group within a group, how would we assess eligibility,
performance, scoring, and application of the MIPS payment adjustment at
the sub-group level; (2) whether all of the sub-group's MIPS
performance data should be aggregated with that of the primary group or
should be treated as a distinct entity for determining the sub-group's
final score, MIPS payment adjustments, and public reporting, and
eligibility be determined at the whole group level; (3) possible low
burden solutions for identification of sub-groups: For example, whether
we should require registration similar to the CMS Web Interface or a
similar mechanism to the low-volume threshold opt-in that we proposed
and is discussed in section III.I.3.c.(5) of this final rule; and (4)
potential issues or solutions needed for sub-groups utilizing
submission mechanisms, measures, or activities, such as APM
participation, that are different than the primary group. We also
welcomed comments on other approaches for sub-group reporting that we
should consider. We received many comments on group reporting and will
take them into consideration for future rulemaking.
f. Virtual Groups
(1) Background
We refer readers to Sec. 414.1315 and the CY 2018 Quality Payment
Program final rule (82 FR 53593 through 53617) for our previously
established policies regarding virtual groups.
(2) Virtual Group Election Process
We refer readers to Sec. 414.1315(c) and the CY 2018 Quality
Payment Program final rule (82 FR 53601 through 53604) for our
previously established policies regarding the virtual group election
process.
We proposed to amend Sec. 414.1315(c) to continue to apply the
previously established policies regarding the virtual group election
process for the 2022 MIPS payment year and future years, with the
exception of the proposed policy modification discussed below (83 FR
35891 through 35892).
Under Sec. 414.1315(c)(2)(ii), an official designated virtual
group representative must submit an election on behalf of the virtual
group by December 31 of the calendar year prior to the start of the
applicable performance period. In the CY 2018 Quality Payment Program
final rule (82 FR 53603), we stated that such election will occur via
email to the Quality Payment Program Service Center using the following
email address for the 2018 and 2019 performance periods:
[email protected] Beginning with the 2022 MIPS payment
year, we proposed to amend Sec. 414.1315(c)(2)(ii) to provide that the
election would occur in a manner specified by CMS. We anticipate that a
virtual group representative would make an election on behalf of a
virtual group by registering to participate in MIPS as a virtual group
via a web-based system developed by CMS. We believe that a web-based
system would be less burdensome for virtual groups given that the
interactions stakeholders would have with the Quality Payment Program
are already conducted via the Quality Payment Program portal, and would
provide stakeholders with a seamless user experience. Stakeholders
would be able to make a virtual group election in a similar manner to
all other interactions with the Quality Payment Program portal and
would no longer need to separately identify the appropriate email
address to submit such an election and email an election outside of the
Quality Payment Program portal. The Quality Payment Program portal is
the gateway and source for interaction with MIPS that contains a range
of information on topics including eligibility, data submission, and
performance reports. We believe that using the same web-based platform
to make a virtual group election would enhance the one-stop MIPS
interactive experience and eliminate the potential for stakeholders to
be unable to identify or erroneously enter the email address.
We solicited public comment on this proposal, which would provide
for an election to occur in a manner specified by CMS such as a web-
based system developed by CMS.
The following is a summary of the public comments received
regarding the proposal to continue to apply the previously established
policies regarding the virtual group election process for the 2022 MIPS
payment year and future years, with the exception of providing for an
election to occur in a manner specified by CMS, such as a web-based
system developed by CMS, and our responses.
Comment: Several commenters supported the proposal to facilitate
virtual group elections through the Quality Payment Program portal, as
opposed to email, and indicated that the use of portal would be less
burdensome for virtual groups and facilitate a more seamless user
experience. A few commenters noted that the web-based system linked to
the existing portal could give interested participants an easier means
of connecting with other possible virtual group members. The commenters
recommended that CMS explore the inclusion/development of a platform
within the portal that would facilitate interactions and connections
between parties interested in forming or joining a virtual group.
Additionally, the commenters requested that CMS clearly outline and
provide additional guidance on the election process via the

[[Page 59743]]

Quality Payment Program website. Another commenter recommended that CMS
devise, as part of the portal, a direct way for clinicians to confirm
their virtual group[hyphen]eligibility status with 100 percent
reliability, and eliminate potential human errors when using a Quality
Payment Program representative as an intermediary.
Response: We will consider various means for providing information
and guidance to virtual groups regarding the election process, and
explore options for facilitating and supporting virtual group formation
and providing virtual group eligibility via the Quality Payment Program
portal in future years. It should be noted that all necessary
information pertaining to virtual groups will be published on the CMS
website prior to the virtual group election period, which occurs during
the calendar before the start of the applicable performance period.
After consideration of the public comments, we are finalizing our
proposal at Sec. 414.1315(c) to continue to apply the previously
established policies regarding the virtual group election process for
the 2022 MIPS payment year and future years, with the exception of
providing for an election to occur in a manner specified by CMS, such
as a web-based system developed by CMS.
(a) Virtual Group Eligibility Determinations
For purposes of determining TIN size for virtual group
participation eligibility for the CY 2018 and 2019 performance periods,
we coined the term ``virtual group eligibility determination period''
and defined it to mean an analysis of claims data during an assessment
period of up to 5 months that would begin on July 1 and end as late as
November 30 of the calendar year prior to the applicable performance
period and includes a 30-day claims run out (82 FR 53602). We proposed
to modify the virtual group eligibility determination period beginning
with the 2019 performance period (83 FR 35892 through 35893). We
proposed to amend Sec. 414.1315(c)(1) to establish a virtual group
eligibility determination period to mean an analysis of claims data
during a 12-month assessment period (fiscal year) that would begin on
October 1 of the calendar year 2 years prior to the applicable
performance period and end on September 30 of the calendar year
preceding the applicable performance period and include a 30-day claims
run out. The virtual group eligibility determination period aligns with
the first segment of data analysis under the MIPS eligibility
determination period. As part of the virtual group eligibility
determination period, TINs would be able to inquire about their TIN
size prior to making an election during a 5-month timeframe, which
would begin on August 1 and end on December 31 of a calendar year prior
to the applicable performance period. TIN size inquiries would be made
through the Quality Payment Program Service Center. For TINs that
inquire about their TIN size during such 5-month timeframe, it should
be noted that any TIN size information provided is only for
informational purposes and may be subject to change; official
eligibility regarding TIN size and all other eligibility pertaining to
virtual groups would be determined in accordance with the MIPS
determination period and other applicable special status eligibility
determination periods. The proposed modification would provide
stakeholders with real-time information regarding TIN size for
informational purposes instead of TIN size eligibility determinations
on an ongoing basis (between July 1 and November 30 of the calendar
year prior to the applicable performance period) due to technical
limitations.
For the 2018 and 2019 performance periods, TINs could determine
their status by contacting their designated TA representative as
provided at Sec. 414.1315(c)(1); otherwise, the TIN's status would be
determined at the time that the TIN's virtual group election is
submitted. We proposed to amend Sec. 414.1315(c)(1) to remove this
provision since the inquiry about TIN size would be for informational
purposes only and may be subject to change.
We believe that the utilization of the Quality Payment Program
Service Center, versus the utilization of designated TA
representatives, as the means for stakeholders to obtain information
regarding TIN size provides continuity and a seamless experience for
stakeholders. We note that the TA resources already available to
stakeholders would continue to be available. The following describes
the experience a stakeholder would encounter when interacting with the
Quality Payment Program Service Center to obtain information pertaining
to TIN size. For example, the applicable performance period for the
2022 MIPS payment year would be CY 2020. If a group contacted the
Quality Payment Program Service Center on September 20, 2019, the
claims data analysis would include the months of October of 2018
through August of 2019. If another group contacted the Quality Payment
Program Service Center on November 20, 2019, the claims data analysis
would include the months of October of 2018 through September of 2019
with a 30-day claims run out.
We believe this virtual group eligibility determination period
provides a real-time representation of TIN size for purposes of
determining virtual group eligibility and allows solo practitioners and
groups to know their real-time virtual group eligibility status and
plan accordingly for virtual group implementation. Beginning with the
2022 MIPS payment year, it is anticipated that starting in August of
each calendar year prior to the applicable performance period, solo
practitioners and groups would be able to contact the Quality Payment
Program Service Center and inquire about their TIN size. TIN size
determinations would be based on the number of NPIs associated with a
TIN, which may include clinicians (NPIs) who do not meet the definition
of a MIPS eligible clinician at Sec. 414.1305 or who are excluded from
MIPS under Sec. 414.1310(b) or (c).
We proposed to continue to apply the aforementioned previously
established virtual group policies for the 2022 MIPS payment year and
future years, with the exception of the following policy modifications:
The virtual group eligibility determination period would
align with the first segment of the MIPS determination period, which
includes an analysis of claims data during a 12-month assessment period
(fiscal year) that would begin on October 1 of the calendar year 2
years prior to the applicable performance period and end on September
30 of the calendar year preceding the applicable performance period and
include a 30-day claims run out. As part of the virtual group
eligibility determination period, TINs would be able to inquire about
their TIN size prior to making an election during a 5-month timeframe,
which would begin on August 1 and end on December 31 of a calendar year
prior to the applicable performance period.
MIPS eligible clinicians would be able to contact their
designated technical assistance representative or, beginning with the
2022 MIPS payment year, the Quality Payment Program Service Center, as
applicable, to inquire about their TIN size for informational purposes
in order to assist MIPS eligible clinicians in determining whether or
not to participate in MIPS as part of a virtual group. We anticipate
that starting in August of each calendar year prior to the applicable
performance period, solo practitioners and groups would be able to
contact the Quality Payment Program

[[Page 59744]]

Service Center and inquire about virtual group participation
eligibility.
A virtual group representative would make an election on
behalf of a virtual group by registering to participate in MIPS as a
virtual group in a form and manner specified by CMS. We anticipate that
a virtual group representative would make the election via a web-based
system developed by CMS.
We also proposed updates to Sec. 414.1315 in an effort to more
clearly and concisely capture previously established policies. These
proposed updates are not intended to be substantive in nature, but
rather to bring more clarity to the regulatory text.
The following is a summary of the public comments received on these
proposals and our responses.
Comment: One commenter requested that CMS revisit the virtual group
definition's current limit of ten clinicians because the definition of
eligible clinician will be expanded. The commenter recommended revising
the definition and measure virtual groups by setting an attributed
membership floor to improve reporting validity.
Response: In regard to determining TIN size for purposes of virtual
group eligibility, we count each NPI associated with a TIN in order to
determine whether or not a TIN exceeds the threshold of 10 NPIs, which
includes clinicians who are eligible and not eligible for MIPS. We
believe that such an approach provides continuity over time if the
definition of a MIPS eligible clinician is expanded in future years
under section 1848(q)(1)(C)(i)(II) of the Act to include other eligible
clinicians (82 FR 53596). As discussed in the 2018 Quality Payment
Program final rule (82 FR 53596 through 53597), we considered an
alternative approach for determining TIN size, which would determine
TIN size for virtual group eligibility based on NPIs who are MIPS
eligible clinicians. However, as we conducted a comparative assessment
of the application of such alternative approach with the current
definition of a MIPS eligible clinician (as defined at Sec. 414.1305)
and a potential expanded definition of a MIPS eligible clinician, we
found that such an approach could create confusion as to which factors
determine virtual group eligibility and cause the pool of virtual group
eligible TINs to significantly be reduced once the definition of a MIPS
eligible clinician would be expanded, which may impact a larger portion
of virtual groups that intend to participate in MIPS as a virtual group
for consecutive performance periods. Such impact would be the result of
the current definition of a MIPS eligible clinician being narrower than
the potential expanded definition of a MIPS eligible clinician. We did
not pursue such an approach given that it did not align with our
objective of establishing virtual group eligibility policies that are
simplistic in understanding and provide continuity.
Furthermore, we note that given that the TIN size is already based
on the total number of NPIs within a TIN, the expanded definition of a
MIPS eligible clinician will not impact the population of TINs eligible
to form or join a virtual group. In regard to increasing the TIN size
threshold of 10, section 1848(q)(5)(I)(ii) of the Act establishes a
threshold of 10 and as a result, we do not have discretion to expand
virtual group participation to TINs with more than 10 NPIs.
Comment: A few commenters supported our proposal to align the
virtual group eligibility determination period with the first segment
of the MIPS determination period for consistency. The commenters also
supported the availability of TIN size information that can be
considered by groups prior to submitting a virtual group election. One
commenter requested that CMS provide notification regarding the
timeframe for the virtual group election process each year.
Response: In regard to the virtual group election period, we
publish the timeframe for virtual groups to make an election in
subregulatory guidance (that is, materials published and posted on the
CMS website and information disseminated via a listserv) each year on
the CMS website in advance of the start of the election period. Each
year, the virtual group election period will occur prior to the start
of an applicable performance period and have an end date of December
31.
Comment: One commenter requested clarification as to why a virtual
group election must be made prior to the performance period and
recommended that CMS postpone the deadline to the third quarter of the
performance year.
Response: Section 1848(q)(5)(I)(iii)(I) of the Act provides that
the virtual group election process must include the following
requirement: An individual MIPS eligible clinician or group electing to
be in a virtual group must make their election prior to the start of
the performance period and cannot change their election during the
performance period.
After consideration of the public comments, we are finalizing our
proposals to continue to apply the aforementioned previously
established virtual group policies for the 2022 MIPS payment year and
future years, with the exception of the following:
The virtual group eligibility determination period is the
first segment of the MIPS determination period (proposal finalized at
Sec. 414.1315(c)(1)(ii)), which consists of an analysis of claims data
during a 12-month assessment period (fiscal year) that begins on
October 1 of the calendar year 2 years prior to the applicable
performance period and ends on September 30 of the calendar year
preceding the applicable performance period and includes a 30-day
claims run out. As part of the virtual group eligibility determination
period, TINs will be able to inquire about their TIN size prior to
making an election during a 5-month timeframe, which will begin on
August 1 and end on December 31 of a calendar year prior to the
applicable performance period. We refer readers to section III.I.3.b.
of this final rule for more information regarding the MIPS
determination period.
MIPS eligible clinicians will be able to contact their
designated technical assistance representative or, beginning with the
2022 MIPS payment year, the Quality Payment Program Service Center, as
applicable, to inquire about their TIN size for informational purposes
in order to assist MIPS eligible clinicians in determining whether or
not to participate in MIPS as part of a virtual group. We anticipate
that starting in August of each calendar year prior to the applicable
performance period, solo practitioners and groups would be able to
contact the Quality Payment Program Service Center and inquire about
virtual group participation eligibility.
A designated virtual group representative must submit an
election, on behalf of the solo practitioners and groups that compose a
virtual group, to participate in MIPS as a virtual group for a
performance period in a form and manner specified by CMS by the
election deadline specified at Sec. 414.1315(b) (proposal finalized at
Sec. 414.1315(c)(2)(ii)) We anticipate that a virtual group
representative will make the election via a web-based system developed
by CMS.
Also, we are finalizing updates to Sec. 414.1315 in an effort to
more clearly and concisely capture previously established policies. The
updates are not intended to be substantive in nature, but rather to
bring more clarity to the regulatory text.
We note that we are further revising Sec. 414.1315 to consolidate
paragraphs (c)(2)(ii) and (iii) and redesignate paragraph (c)(2)(iv) as
paragraph (c)(2)(iii) for clarity. Additionally, we are revising
redesignated paragraph

[[Page 59745]]

(c)(2)(iii) to refer to ``the start of data submission'' rather than
``the start of an applicable submission period'' because ``submission
period'' is not an expressly defined term.
g. MIPS Performance Period
In the CY 2018 Quality Payment Program final rule (82 FR 53617
through 53619), we finalized at Sec. 414.1320(c)(1) that for purposes
of the 2021 MIPS payment year, the performance period for the quality
and cost performance categories is CY 2019 (January 1, 2019 through
December 31, 2019). We did not finalize the performance period for the
quality and cost performance categories for purposes of the 2022 MIPS
payment year or future years. We also redesignated Sec. 414.1320(d)(1)
and finalized at Sec. 414.1320(c)(2) that for purposes of the 2021
MIPS payment year, the performance period for the Promoting
Interoperability and improvement activities performance categories is a
minimum of a continuous 90-day period within CY 2019, up to and
including the full CY 2019 (January 1, 2019 through December 31, 2019).
As noted in the CY 2018 Quality Payment Program final rule, we
received comments that were not supportive of a full calendar year
performance period for the quality and cost performance categories.
However, we continue to believe that a full calendar year performance
period for the quality and cost performance categories will be less
confusing for MIPS eligible clinicians. As discussed in the CY 2019 PFS
proposed rule (83 FR 35893), we believe that a longer performance
period for the quality and cost performance categories will likely
include more patient encounters, which will increase the denominator of
the quality and cost measures. Statistically, larger sample sizes
provide more accurate and actionable information. Additionally, a full
calendar year performance period is consistent with how many of the
measures used in our program were designed to be performed and
reported. We also noted that the Bipartisan Budget Act of 2018 (Pub. L.
115-119, enacted February 9, 2018) has provided further flexibility to
the 3rd, 4th, and 5th years of MIPS to help continue the gradual
transition to MIPS.
Regarding the Promoting Interoperability performance category, we
have heard from stakeholders through public comments, letters, and
listening sessions that they oppose a full year performance period,
indicating that it is very challenging and may add administrative
burdens (83 FR 35893). Some stated that a 90-day performance period is
necessary in order to enable clinicians to have a greater focus on the
objectives and measures that promote patient safety, support clinical
effectiveness, and drive toward advanced use of health IT. They also
noted that as this performance category requires the use of CEHRT, a
90-day performance period will help relieve pressure on clinicians to
quickly implement changes and updates from their CEHRT vendors and
developers so that patient care is not compromised. Others cited the
challenges associated with reporting on a full calendar year for
clinicians newly employed by a health system or practice during the
course of a program year, switching CEHRT, vendor issues, system
downtime, cyber-attacks, difficulty getting data from old places of
employment, and office relocation. Most stakeholders stated that the
performance period should be 90 days in perpetuity, as this would
greatly reduce the reporting burden (83 FR 35893).
In the CY 2019 PFS proposed rule (83 FR 35893), in an effort to
provide as much transparency as possible so that MIPS eligible
clinicians and groups may plan for participation in the program, we
requested comments on our proposals at Sec. 414.1320(d)(1) that for
purposes of the 2022 MIPS payment year and future years, the
performance period for the quality and cost performance categories
would be the full calendar year (January 1 through December 31) that
occurs 2 years prior to the applicable MIPS payment year. For example,
for the 2022 MIPS payment year, the performance period would be 2020
(January 1, 2020 through December 31, 2020), and for the 2023 MIPS
payment year, the performance period would be CY 2021 (January 1, 2021
through December 31, 2021).
In addition, we requested comments on our proposal at Sec.
414.1320(d)(2) that for purposes of the 2022 MIPS payment year and
future years, the performance period for the improvement activities
performance category would be a minimum of a continuous 90-day period
within the calendar year that occurs 2 years prior to the applicable
MIPS payment year, up to and including the full calendar year. For
example, for the 2022 MIPS payment year, the performance period for the
improvement activities performance category would be a minimum of a
continuous 90-day period within CY 2020, up to and including the full
CY 2020 (January 1, 2020 through December 31, 2020). For the 2023 MIPS
payment year, the performance period for the improvement activities
performance category would be a minimum of a continuous 90-day period
within CY 2021, up to and including the full CY 2021 (January 1, 2021
through December 31, 2021) that occurs 2 years before the MIPS payment
year (83 FR 35893).
Finally, we requested comments on our proposal to add Sec.
414.1320(e)(1) that for purposes of the 2022 MIPS payment year, the
performance period for the Promoting Interoperability performance
category would be a minimum of a continuous 90-day period within the
calendar year that occurs 2 years prior to the applicable MIPS payment
year, up to and including the full calendar year. Thus, for the 2022
MIPS payment year, the performance period for the Promoting
Interoperability performance category would be a minimum of a
continuous 90-day period within CY 2020, up to and including the full
CY 2020 (January 1, 2020 through December 31, 2020) (83 FR 35893).
The following is a summary of the public comments received on these
proposals and our responses:
Comment: Several commenters agreed with our proposal to maintain
the quality and cost performance periods as a full calendar year that
occurs 2 years prior to the applicable MIPS payment year, noting that
this proposal provides some of the stability needed for MIPS. One
commenter supported a full calendar year for the cost performance
category as this allows for a greater number of cases to be included in
each measure, which will give a more reliable performance result.
Another commenter supported a full calendar year for the quality and
cost performance categories because they stated that it is in the best
interest of patients encouraging clinicians to evolve in their approach
to delivering care.
Response: We appreciate the commenters' support.
Comment: Several commenters opposed a full calendar-year
performance period for the quality and cost performance categories and
urged CMS to establish a minimum 90-day performance period, consistent
with the other performance categories. Commenters noted that a minimum
of 90-day performance period would reduce the administrative burden in
MIPS, align the performance period across MIPS performance categories
and allow the agency to shorten the 2-year lag between performance and
payment. Other commenters requested that clinicians be allowed to
choose between 90 days up to a full year of reporting. Another
commenter urged CMS to consider adopting a 90-day performance period to
capture eligible clinicians who may join a group in the middle of a
performance year. One commenter agreed with the challenges CMS

[[Page 59746]]

outlined in the proposed rule (83 FR 35893) regarding the Promoting
Interoperability performance category and stated that these various
challenges create obstacles outside the control of the clinician, which
inhibits their ability to collect and report 12 months of MIPS data for
the quality performance category as well.
Response: We do not believe that it would be in the best interest
of MIPS eligible clinicians to have less than a full calendar year
performance period for the quality and cost performance categories for
the 2022 MIPS payment year and future years, as we are maintaining
consistency with the performance period established for the first 3
MIPS payment years. We believe this will be less burdensome and
confusing for MIPS eligible clinicians. As discussed in the CY 2018
Quality Payment Program final rule (82 FR 53618), statistically, larger
sample sizes provide more accurate and actionable information.
Additionally, a full calendar year performance period is consistent
with how many of the measures used in our program were designed to be
reported and performed; some of the measures do not allow for a 90-day
performance period. We believe these issues make the quality
performance category inherently different for reporting requirements
and measures than the Promoting Interoperability and improvement
activities performance categories. We do not believe reducing the
performance period for the quality and cost performance categories will
alleviate any issues with clinicians switching practices. Regarding
reducing the 2-year lag between performance and payment, as noted in
the CY 2017 Quality Payment Final Rule (81 FR 77077), the data
submission activities and claims for services furnished during the 1
year performance period (which could be used for claims- or
administrative claims-based quality or cost measures) may not be fully
processed until the following year. These circumstances require
adequate lead time to collect performance data, assess performance, and
compute the MIPS adjustment so the applicable MIPS adjustment can be
made available to each MIPS eligible clinician at least 30 days prior
to when the MIPS payment adjustment is applied each year. Finally, in
regard to the challenges we outlined in the proposed rule (83 FR
35893), these were specifically referring to the Promoting
Interoperability performance category. We do not believe that these
challenges affect the quality performance category, as well.
Comment: A few commenters noted that establishing a 90-day
performance period would give CMS an opportunity to set benchmarks
based on more current data, rather than from 4 years prior to the
applicable MIPS payment year.
Response: We believe that benchmarks based on data from a 90-day
performance period would be less reliable than those based on a full
calendar year because fewer reported instances would meet the case
minimum needed to be included in the benchmarks. This would also cause
some measures to not have an available benchmark that could be used for
scoring. In addition, using a 90-day performance period would not allow
the creation of benchmarks from more current data. This is because we
would still need to wait until the end of the data submission period
before we could create the benchmarks based on data submitted by all
MIPS eligible clinicians, and to publish historical benchmarks prior to
the beginning of the performance period, we would still need to use
data from 2 years prior to the performance period (4 years prior to the
MIPS payment year).
Comment: Several commenters supported the proposal to keep the
minimum performance period for the improvement activities performance
category at 90 days, noting the proposal maintains stability and
simplifies the program. One commenter stated that practices should be
able to complete improvement activities lasting 90 days even if the
performance spans over two performance periods. The commenter stated
that CMS should require practices to complete at least 45 consecutive
days during each of two consecutive performance periods to equal a
total of at least 90 days, noting that this lowers the burden on
clinicians and further encourages participation in this performance
category.
Response: We appreciate the support for our proposal. However, we
do not agree that an improvement activity should be split into two, 45-
day periods. As discussed in the CY 2017 Quality Payment Program final
rule (81 FR 77186), after researching several organizations, we believe
a minimum of 90 days is a reasonable amount of time required for
performing an activity. We do not believe that performance periods as
short as 45 days are sufficient for many of the available improvement
activities to ensure that the activities being performed result in
actual practice improvements.
Comment: One commenter opposed our proposal to keep the minimum
performance period for the improvement activities performance category
at 90-days and urged CMS to adopt a 12-month performance period. The
commenter noted that a 12-month performance period may be in the best
interest of patients and may evolve clinicians' approach to delivering
care.
Response: We appreciate the commenters' recommendation. However, we
believe that a minimum of a continuous 90-day performance period is
appropriate for MIPS eligible clinicians to perform improvement
activities that would improve clinical practice and provides more
flexibility as some improvement activities may be ongoing, while others
may be appropriately episodic.
Comment: Many commenters supported our proposal to keep the minimum
performance period for the Promoting Interoperability performance
category at 90 days, noting that this proposal maintains stability,
helps reduce administrative burden, provides clinicians with the time
needed to manage changes and updates from their CEHRT vendors and
developers, allows for effective measurement, and allows clinicians the
flexibility to address scheduled or unanticipated events such as
switching EHR vendors, system downtime, and cyber-attacks without
jeopardizing patient care. Several commenters requested that CMS
consider extending this performance period beyond the CY 2020 MIPS
performance period.
Response: We appreciate the commenters' support. We believe it is
premature to establish policy beyond CY 2020 at this time appreciating
the continued work in this area across HHS. We are finalizing the
Promoting Interoperability performance period specific to CY 2019. We
will take the comment into consideration for future rulemaking.
Comment: One commenter requested that CMS investigate ways to
shorten the time between performance periods and for future MIPS
payment years in the Quality Payment Program. This commenter noted
concern that 2 years is too long to impact practice patterns and lead
to meaningful changes in behavior.
Response: We understand the commenter's concern. However, as
discussed in the CY 2017 Quality Payment Program final rule (81 FR
77083), there is a ``2-year lag'' at this time, in order to account for
the post-submission processes of calculating the MIPS eligible
clinician's final score, establishing budget neutrality and issuing the
MIPS payment adjustment factors, and allowing for a targeted review
period to occur prior to the application of the MIPS payment

[[Page 59747]]

adjustment. We will continue working to shorten the ``2-year lag'' that
the commenter describes.
Comment: Several commenters urged CMS to consider the timing of
previous year MIPS feedback reports, which are released in July after
the close of the performance period, noting that this timeline does not
allow for clinicians to make necessary changes before the beginning of
the next performance period. Several commenters noted that, if the
performance period was reduced to a 90-day minimum with the option to
submit additional data, individuals and groups would have greater
flexibility to incorporate previous MIPS feedback into their
performance during the remaining portion of 2019, thereby increasing
quality and patient safety, and to focus more of their attention on
improving patient care.
Response: Regarding the release of the feedback reports for the 1st
year of MIPS, we provided 3 rounds of feedback including: (1) Round 1--
at the point of submission feedback; (2) round 2--pre-performance
feedback; and (3) round 3--performance feedback. First, in round 1, at
the point of submission we provided real time feedback that was
available from the opening to the close of the submission period.
Second, in round 2, we provided pre-performance feedback, which was
available at the beginning of the close of the submission period and
updated the round 2 feedback as new data became available such as CAHPS
for MIPS survey, all-cause readmission measure, and cost measures data.
Third, in round 3, we provided performance feedback that while it looks
similar to round 2 is different in that the data is final with no new
data being added and the payment adjustment(s) is included. This is the
data that can be used to determine if a targeted review is to be filed.
Considering there are opportunities for a clinician to gain insight
into their possible performance prior to the release of the performance
feedback in July, we encourage MIPS eligible clinicians to review the
preliminary feedback and make necessary process and performance
improvements, as needed. While we agree that there is some benefit to a
90-day performance period, we believe that more continuous feedback is
more beneficial. We also note that operationally our goal is to provide
as much continuous submission opportunity as we can support in the
future, including allowing clinicians to submit data during the
performance period, as feasible. The ability to receive more frequent
and continuous submissions will further our ability to provide more
frequent feedback to MIPS eligible clinicians.
Comment: A few commenters did not support the 90-day performance
period for the Promoting Interoperability performance category and
urged CMS to move to full calendar year reporting as soon as possible
to achieve value-based care, stating that patients and families should
be able to experience the benefits of health IT any day of the year,
rather than a particular 3-month period. One commenter noted that a 12-
month performance period would more effectively achieve the objectives
of MACRA. One commenter also noted that requiring full-year reporting
would be less burdensome because it aligns with performance period for
the quality performance category. Finally, one commenter also noted
that requiring full-year reporting is more likely to prompt changes to
clinician workflows.
Response: Although the performance period for the Promoting
Interoperability performance category is a minimum of a continuous 90-
day period during the calendar year, clinicians may report for a period
up to and including the full calendar year. In addition, we do not
believe that the duration of the performance period is indicative of
the availability of the EHR to patients. We believe it is likely that a
clinician who uses an EHR for a period of 90 days will continue to use
it year round.
Comment: One commenter urged us to consider the practical
implications of a 90-day performance period for Promoting
Interoperability measure reporting, emphasizing the need to ensure MIPS
eligible clinicians and groups maintain interoperability capabilities
in months that are not in the Promoting Interoperability performance
period. This commenter noted the reporting periods may vary across
eligible clinicians and groups and that a 90-day performance period
could reduce the MIPS program's incentives for interoperability and may
delay roll-out of enhanced interoperability functionality.
Response: While MIPS eligible clinicians are required to report for
a minimum of 90 days, they have the flexibility to report for a longer
performance if they choose. Further we believe that once CEHRT is being
utilized by the MIPS eligible clinician, it will be used on an ongoing
basis and not just during a 90-day performance period.
After consideration of the public comments received, we are
finalizing our proposal at Sec. 414.1320(d)(1) that for purposes of
the 2022 MIPS payment year and future years, the performance period for
the quality and cost performance categories would be the full calendar
year (January 1 through December 31) that occurs 2 years prior to the
applicable MIPS payment year. In addition, we are finalizing our
proposal at Sec. 414.1320(d)(2) that for purposes of the 2022 MIPS
payment year and future years, the performance period for the
improvement activities performance category would be a minimum of a
continuous 90-day period within the calendar year that occurs 2 years
prior to the applicable MIPS payment year, up to and including the full
calendar year. We are also finalizing our proposal to add at Sec.
414.1320(e)(1) that for purposes of the 2022 MIPS payment year, the
performance period for the Promoting Interoperability performance
category would be a minimum of a continuous 90-day period within the
calendar year that occurs 2 years prior to the applicable MIPS payment
year, up to and including the full calendar year. Finally, we are
finalizing revisions to Sec. 414.1320(b)(2) and (c)(2) to refer to the
new name of the Promoting Interoperability performance category.
h. MIPS Performance Category Measures and Activities
(1) Data Submission Requirements
(a) Background
We refer readers to Sec. 414.1325 and the CY 2017 and CY 2018
Quality Payment Program final rules (81 FR 77087 through 77095, and 82
FR 53619 through 53626, respectively) for our previously established
policies regarding data submission requirements.
(b) Collection Types, Submission Types and Submitter Types
It has come to our attention that the way we have previously
described data submission by MIPS eligible clinicians, groups and third
party intermediaries does not precisely reflect the experience users
have when submitting data to us. To clarify, we have previously used
the term ``submission mechanisms'' to refer not only to the mechanism
by which data is submitted, but also to certain types of measures and
activities on which data are submitted (for example, electronic
clinical quality measures (eCQMs) reported via EHR) and to the entities
submitting such data (for example, third party intermediaries on behalf
of MIPS eligible clinicians and groups). To ensure clarity and
precision for all users, we are proposing to revise existing and define
additional terminology to more precisely reflect the experience users
have when submitting data to the Quality Payment Program.

[[Page 59748]]

In the CY 2019 PFS proposed rule (83 FR 35894), we requested
comments on our proposal to define the following terms at Sec.
414.1305:
Collection type as a set of quality measures with
comparable specifications and data completeness criteria, including, as
applicable: eCQMs; MIPS Clinical Quality Measures (MIPS CQMs); QCDR
measures; Medicare Part B claims measures; CMS Web Interface measures;
the CAHPS for MIPS survey; and administrative claims measures. The term
MIPS CQMs would replace what was formerly referred to as registry
measures since entities other than registries may submit data on these
measures. These new terms are referenced in the collection type field
for the following measure tables of the appendices in the CY 2019 PFS
proposed rule (83 FR 36092 through 36358): Table Group A: Proposed New
Quality Measures for Inclusion in MIPS for the 2021 MIPS Payment Year
and Future Years; Table Group B: Proposed New and Modified MIPS
Specialty Measure Sets for the 2021 MIPS Payment Year and Future Years;
Table C: Quality Measures Proposed for Removal from the Merit-Based
Incentive Payment System Program for the 2019 Performance Period and
Future Years; and Table Group D: Measures with Substantive Changes
Proposed for the 2021 MIPS Payment Year and Future Years.
Submitter type as the MIPS eligible clinician, group, or
third party intermediary acting on behalf of a MIPS eligible clinician
or group, as applicable, that submits data on measures and activities
under MIPS.
Submission type as the mechanism by which a submitter type
submits data to CMS, including, as applicable: Direct, log in and
upload, log in and attest, Medicare Part B claims and the CMS Web
Interface. The direct submission type allows users to transmit data
through a computer-to-computer interaction, such as an API. The log in
and upload submission type allows users to upload and submit data in
the form and manner specified by CMS with a set of authenticated
credentials. The log in and attest submission type allows users to
manually attest that certain measures and activities were performed in
the form and manner specified by CMS with a set of authenticated
credentials. We note that there is no submission type for the
administrative claims collection type because we calculate measures for
this collection type based on administrative claims data available to
us.
In the CY 2019 PFS proposed rule (83 FR 35894), we solicited
additional feedback and alternative suggestions on terminology that
appropriately reflects the concepts described in the proposed
definitions of collection type, submitter type and submission type, as
well as the term MIPS CQMs to replace the formerly used term of
registry measures.
The following is a summary of the comments we received on
``Collection Types, Submission Types and Submitter Types''.
Comment: A few commenters supported the clarification of submission
terms, stating that the new definitions recognize the complexity of
measure types and submission options and reduce the potential for
confusion. Commenters asked whether, if we finalize these terminology
updates, educational information will be made available on the Quality
Payment Program website so that clinicians will understand and
appropriately apply these terms. One commenter also emphasized the
importance of ensuring that submitting and attesting to measures is
flexible and easy for clinicians to do.
Response: We intend to update the Quality Payment Program website
appropriately and provide any relevant educational materials.
Comment: One commenter recommended that, if the ``collection type''
definition only refers to quality measures, CMS change ``collection
type'' to ``quality measure type'' and requested that CMS provide a
definition for data collection recognizing that all performance
categories collect data. Another commenter also recommended that we
recommend that we change ``collection type'' to ``measure type'' or
``measure category'' to more intuitively and accurately reflect the
meaning of the term.
Response: The proposed definition of collection type states that it
is specific to a set of quality measures. Therefore, we do not agree
the suggested term of ``quality measure type'' would be the most
beneficial in clarifying the actual submission experience for the user,
in comparison to how submission mechanisms were discussed in our
previous policies. We also note that the usage of the term ``quality
measure type'' is commonly used to refer to mean a specific type of
measure such as process or outcome measure. While we agree that all
performance categories do in fact collect data, for purposes of
clarifying the user experience for data submission, it is most
beneficial to only refer to data collection in regards to the quality
performance category. The suggested terms ``measure type'' or ``measure
category'' could create further misunderstanding of the intent of the
definition. As far as ``measure type'', there are other measures
available in the program than just those available for reporting on in
the quality performance category. For the term ``measure category'', we
disagree as this could give the implication that this is another
performance category within the Quality Payment Program.
Comment: One commenter recommended that we change the term
``submission type'' to ``submission method'' and to define the
mechanisms by which CMS means by ``direct,'' ``log in,'' ``upload,''
and ``attest.''
Response: We agree that the term ``submission method'' is an
appropriate term for the proposed definition. However, the term did not
gain support during user testing that surpassed the proposed terms.
According to feedback from user testing, the proposed terms of
collection, submitter and submission type, were found to be intuitive
and to match the user experience when submitting data to the Quality
Payment Program. The direct, log in and upload, log in and attest modes
of data submission will be discussed in further detail in forthcoming
educational resources. We also encourage review of the terms and
wireframes for the submission types on qpp.cms.gov/design-examples.
Comment: One commenter recommended that we change ``submitter
type'' to ``submitting entity'' and define this as the entity who will
be submitting the eligible clinician's data.
Response: We believe that consistent terminology would be most
beneficial in providing clarity for users submitting data to the
Quality Payment Program. We also note that the term submitter type
includes both entities that would submit on a clinician's behalf, as
well as actions made directly by clinicians or their practice.
After consideration of the public comments received, we are
finalizing our proposal at Sec. 414.1305 to define the following
terms:
Collection type as a set of quality measures with
comparable specifications and data completeness criteria, including, as
applicable: eCQMs; MIPS Clinical Quality Measures (MIPS CQMs); QCDR
measures; Medicare Part B claims measures; CMS Web Interface measures;
the CAHPS for MIPS survey; and administrative claims measures. The term
MIPS CQMs would replace what was formerly referred to as registry
measures since entities other than registries may submit data on these
measures. These new terms are referenced in the collection type field
for the following measure tables of ``Appendix 1: Finalized MIPS
Quality

[[Page 59749]]

Measures'' in this final rule: Table Group A: Finalized New Quality
Measures for Inclusion in MIPS for the 2021 MIPS Payment Year and
Future Years; Table Group B: Finalized New and Modified MIPS Specialty
Measure Sets for the 2021 MIPS Payment Year and Future Years; Table
Group C: Quality Measures Finalized for Removal in the 2021 MIPS
Payment Year and Future Years; and Table Group D: Measures with
Substantive Changes Finalized for the 2021 MIPS Payment Year and Future
Years.
Submitter type as the MIPS eligible clinician, group, or
third party intermediary acting on behalf of a MIPS eligible clinician
or group, as applicable, that submits data on measures and activities
under MIPS.
Submission type as the mechanism by which a submitter type
submits data to CMS, including, as applicable: Direct, log in and
upload, log in and attest, Medicare Part B claims and the CMS Web
Interface. The direct submission type allows users to transmit data
through a computer-to-computer interaction, such as an API. The log in
and upload submission type allows users to upload and submit data in
the form and manner specified by CMS with a set of authenticated
credentials. The log in and attest submission type allows users to
manually attest that certain measures and activities were performed in
the form and manner specified by CMS with a set of authenticated
credentials. We note that there is no submission type for the
administrative claims collection type because we calculate measures for
this collection type based on administrative claims data available to
us.
(c) Performance Category Measures and Reporting
We previously finalized at Sec. 414.1325(a) and (e), respectively,
that MIPS eligible clinicians and groups must submit measures,
objectives, and activities for the quality, improvement activities, and
advancing care information performance categories and that there are no
data submission requirements for the cost performance category and for
certain quality measures used to assess performance in the quality
performance category; CMS will calculate performance on these measures
using administrative claims data. In the CY 2019 PFS proposed rule (83
FR 35894), we proposed to amend Sec. 414.1325(a) to incorporate Sec.
414.1325(e), as they both address which performance categories require
data submission; Sec. 414.1325(f) would be redesignated as Sec.
414.1325(e). We also proposed in the CY 2019 PFS proposed rule (83 FR
35894) at Sec. 414.1325(a)(2)(ii) that there is no data submission
requirement for the quality or cost performance category, as
applicable, for MIPS eligible clinicians and groups that are scored
under the facility-based measurement scoring methodology described in
Sec. 414.1380(e). We also recognized the need to clarify to users how
they submit data to us. In the CY 2019 PFS proposed rule (83 FR 35894),
there are five basic submission types that we proposed to define in
MIPS: Direct; log in and upload; login and attest; Medicare Part B
claims; and the CMS Web Interface. We proposed to reorganize Sec.
414.1325(b) and (c) by performance category in the CY 2019 PFS proposed
rule (83 FR 35894). We proposed in the CY 2019 PFS proposed rule (83 FR
35894) to also clarify at Sec. 414.1325(b)(1) that an individual MIPS
eligible clinician may submit their MIPS data for the quality
performance category using the direct, login and upload, and Medicare
Part B claims submission types. In the CY 2019 PFS proposed rule (83 FR
35894), similarly, we proposed to clarify at Sec. 414.1325(b)(2) that
an individual MIPS eligible clinician may submit their MIPS data for
the improvement activities or Promoting Interoperability performance
categories using the direct, login and upload, or login and attest
submission types. As for groups, we proposed in the CY 2019 PFS
proposed rule (83 FR 35894) to clarify at Sec. 414.1325(c)(1) that
groups may submit their MIPS data for the quality performance category
using the direct, login and upload, and CMS Web Interface (for groups
consisting of 25 or more eligible clinicians) submission types. Lastly,
we proposed to clarify at Sec. 414.1325(c)(2) that groups may submit
their MIPS data for the improvement activities or Promoting
Interoperability performance categories using the direct, login and
upload, or login and attest submission types in the CY 2019 PFS
proposed rule (83 FR 35894). We believe that these clarifications will
enhance the submission experience for clinicians and other
stakeholders. As technology continues to evolve, we will continue to
look for new ways that we can offer further technical flexibilities on
submitting data to the Quality Payment Program. In the CY 2019 PFS
proposed rule (83 FR 35894), we requested comment on these proposals.
To assist commenters in providing pertinent comments, we developed a
website that uses wireframe (schematic) drawings to illustrate a subset
of the different submission types available for MIPS participation.
Specifically, the wireframe drawings describe the direct, login and
attest, and login and upload submission types. We refer readers to the
Quality Payment Program at qpp.cms.gov/design-examples to review these
wireframe drawings. The website will provide specific matrices
illustrating potential stakeholder experiences when choosing to submit
data under MIPS.
As previously expressed in the 2017 Quality Payment Program final
rule (81 FR 77090), we want to move away from claims reporting, since
approximately 69 percent of the Medicare Part B claims measures are
topped out. Although we would like to move towards the utilization of
electronic reporting by all clinicians and groups, we realize that
small practices face additional challenges, and this requirement may
limit their ability to participate. For this reason, we believe that
Medicare Part B claims measures should be available to small practices,
regardless of whether they are reporting as individual MIPS eligible
clinicians or as groups. Therefore, we proposed amending Sec.
414.1325(c)(1) to make the Medicare Part B claims collection type
available to MIPS eligible clinicians in small practices beginning with
the 2021 MIPS payment year in the CY 2019 PFS proposed rule (83 FR
35894). Although this will limit the current availability of Medicare
Part B claims measures for individual MIPS eligible clinicians that do
not meet the definition of a small practice, it will expand the
availability of such measures for small practices who choose to
participate in MIPS as a group, which currently does not have a claims-
based reporting option as a group.
Under Sec. 414.1325(c)(4), we previously finalized that groups may
submit their MIPS data using the CMS Web Interface (for groups
consisting of 25 or more eligible clinicians) for the quality,
improvement activities, and promoting interoperability performance
categories. In the CY 2019 PFS proposed rule (83 FR 35894 through
35895), we proposed that the CMS Web Interface submission type would no
longer be available for groups to use to submit data for the
improvement activities and Promoting Interoperability performance
categories at Sec. 414.1325(c)(2). The CMS Web Interface has been
designed based on user feedback as a method for quality submissions
only; however, groups that elect to utilize the CMS Web Interface can
still submit improvement activities or promoting interoperability data
via direct, log in and attest or log in and upload submission types. We
also recognized that certain groups that have elected to use the CMS
Web Interface

[[Page 59750]]

may prefer to have their data submitted on their behalf by a third
party intermediary described at Sec. 414.1400(a). We recognized the
benefit and burden reduction in such a flexibility and therefore
proposed to allow third party intermediaries to submit data to the CMS
Web Interface in addition to groups in the CY 2019 PFS proposed rule
(83 FR 35895). Specifically, we proposed in the CY 2019 PFS proposed
rule (83 FR 35895) to redesignate Sec. 414.1325(c)(4) as Sec.
414.1325(c)(1) and amend Sec. 414.1325(c)(1) to allow third party
intermediaries to submit data using the CMS Web Interface on behalf of
groups. To further our efforts to provide flexibility in reporting to
the Quality Payment Program, we solicited comment in the CY 2019 PFS
proposed rule (83 FR 35895) on expanding the CMS Web Interface
submission type to groups consisting of 16 or more eligible clinicians
to inform our future rulemaking.
We previously finalized at Sec. 414.1325(e) that there are no data
submission requirements for the cost performance category and for
certain quality measures used to assess performance in the quality
performance category and that CMS will calculate performance on these
measures using administrative claims data. We also finalized at Sec.
414.1325(f)(2), (which, as noted, we proposed to redesignate as Sec.
414.1325(e)(2)) that for Medicare Part B claims, data must be submitted
on claims with dates of service during the performance period that must
be processed no later than 60 days following the close of the
performance period. We neglected to codify this requirement at Sec.
414.1325(e) (which, as noted, we proposed to consolidate with Sec.
414.1325(a)) for administrative claims data used to assess performance
in the cost performance category and for administrative claims-based
quality measures. Therefore, in the CY 2019 PFS proposed rule (83 FR
35895), we proposed to amend Sec. 414.1325(a)(2)(i) to reflect that
claims included in the measures are those submitted with dates of
service during the performance period that are processed no later than
60 days following the close of the performance period.
In the CY 2019 PFS proposed rule (83 FR 35895), a summary of these
proposed changes is included in Tables 32 and 33. For reference, Table
32 summarizes the data submission types for individual MIPS eligible
clinicians that we proposed at Sec. 414.1325(b) and (e) in the CY 2019
PFS proposed rule (83 FR 35895). Table 33 summarizes the data
submission types for groups that we proposed at Sec. 414.1325(c) and
(e) in the CY 2019 PFS proposed rule (83 FR 35895 through 35896). We
requested comment on these proposals.
The following is a summary of the comments we received on
``Performance Category Measures and Reporting''.
Comment: Many commenters supported our proposal to allow small
practices to use the Medicare Part B claims-based reporting option for
group reporting, with some noting that this option specifically
relieves the burden on rural providers. However, several of these
commenters opposed limiting the Medicare Part B claims reporting to
only clinicians in small practices, stating that many clinicians are
excluded from the special small practice policies despite operating as
small practices in all other respects, and there may be circumstances
where reporting via Medicare Part B claims as individuals is the best
option for clinicians in larger multispecialty practices to allow each
clinician to focus on quality measures most relevant to his/her
specialty and scope of practice. A few commenters stated that this
policy would result in a negative impact on clinicians who are part of
specialties that do not have relevant eCQMs available to them, but have
nonetheless implemented workflows to support reporting data using
Medicare Part B claims; requiring them to change these workflows based
solely on practice size would cause unnecessary clinician burden
without an offsetting benefit to the clinician already participating in
the program. Therefore, these commenters recommended that CMS retain
the Medicare Part B claims-based reporting option in the quality
performance category for all clinicians regardless of practice size.
One commenter also requested that we provide a definition for a small
practice in the final rule.
Response: We likewise acknowledge that many clinicians that are not
in a small practice currently report via Medicare Part B claims.
However, as we previously expressed in the CY 2017 Quality Payment
Program final rule (81 FR 77090), we want to move away from claims
reporting, as more measures are available through health IT mechanisms
such as registries, QCDRs, and health IT vendors. We believe it is
important to move away from manual methods of reporting and instead
utilize more electronic methods such as using EHRs, registries, QCDRs.
Also, as we have described above with our revised terms, clinicians
that are part of a practice that opts not to work with a third party
intermediary can submit data directly to us, which is a flexibility we
have under MIPS that was not available under the legacy programs. We
note that this change does not require the use of eCQMs by MIPS
eligible clinicians that are not considered to be part of a small
practice. Rather, MIPS eligible clinicians that do not meet the
definition of a small practice will have the ability to select from all
other collection types. We refer readers to Sec. 414.1305 for the
definition of small practice.
Comment: A few commenters did not support the proposal to make the
Medicare Part B claims collection type available to clinicians in small
practices, stating that it does not align with the objectives of
electronic reporting and Promoting Interoperability. Commenters
specifically stated that the small administrative burden to implement
CEHRT exceeds the cost of the various benefits of utilizing technology
to improve the quality of care and that CEHRT is the only method that
is completely accurate based upon the patient record and prevents
organizations from ``cherry-picking'' patients to meet the 60 percent
reporting threshold. One commenter also noted that registries are
available at very affordable costs for clinicians and groups. Another
commenter stated concern about how small and rural practices that have
made the financial investment into CEHRT would react to this proposed
update, stating that the proposal sends an inconsistent message to
those small and rural psychiatric practices that made the financial
investment to adopt CEHRT.
Response: To clarify, our policy is to make the Medicare Part B
claims collection type only available to small practices. We agree that
there are many benefits to CEHRT adoption and also agree that many
registries are available at low cost. We do not agree that this sends
an inconsistent message with the objectives of electronic reporting and
Promoting Interoperability as we still encourage all clinicians (small
practices and non-small practices) to submit electronically. However,
we recognize that small practices have additional challenges and
believe that continuing to allow the Medicare Part B claims collection
type only to small practices is beneficial. To further highlight
alignment in policy regarding small practices across performance
categories in MIPS, as discussed in section III.I.3.h.(5) of this final
rule for the Promoting Interoperability performance category, small
practices can apply for a significant hardship exception if they have
issues acquiring an EHR.
Comment: Several commenters opposed the proposed removal of
Medicare Part B claims-based reporting

[[Page 59751]]

as an option for clinicians. One commenter noted concern because the
proposal to expand the definition of a MIPS eligible clinician stated
it would also coincide with a decrease in the number of group practices
that will be considered a small practice. Commenters requested that CMS
finalize a future timeframe for retiring the Medicare Part B claims
based submission type for eligible clinicians, stating that: Medicare
Part B claims based submission of quality data is still an extremely
popular submission method in certain specialties; eliminating this
reporting option may reduce the number of clinicians who participate in
MIPS reporting; clinicians in many specialties, most notably those that
are hospital based, will have to transition to use of a qualified
registry or QCDR for quality measure reporting once claims based
reporting is no longer an option, and this will require new and
unplanned costs and further burden. Commenters also noted that
clinicians who elect to report via Medicare Part B claims-based
reporting, and choose to report topped out measures, are penalized in
their quality score under current methods by receiving a maximum of 7
of 10 points for each topped out measure; therefore there is not an
inappropriate incentive for continued use of this method. Another
commenter stated that the removal of Medicare Part B claims reporting
contradicts the provisions in the Bipartisan Budget Act of 2018 that
moves the Agency toward accepting more claims data. Another commenter
recommended waiting to see if the number of clinicians reporting
through Medicare Part B claims increases over the next years and then
determine if a future proposal is appropriate.
Response: We acknowledge that many clinicians that are not in a
small practice currently report via Medicare Part B claims. However, we
disagree that only allowing the reporting of this collection type to
small practices forces non-small practices to transition to the use of
a qualified registry or QCDR for quality measure reporting, as there
are other collection types and submitter types available in which non-
small practices can report (that is, eCQMs, MIPS CQMs, CMS Web
Interface measures, the CMS approved survey vendor measure and
Administrative claims measures). For example, a non-small practice that
does not wish to enter into an arrangement with a third party
intermediary can use the MIPS CQM collection type and either login and
upload their data or use the direct submission type for the quality
performance category. These submission types do not require the usage
of a third party intermediary, but we note that there are certain
technical capabilities that a practice must have to submit data in this
manner. Additional details on the form and manner requirements of these
submission types is available at qpp.cms.gov/design-examples.
We agree that choosing to report topped out measures is not
incentivized. As discussed in the CY 2019 PFS proposed rule (83 FR
35894), we want to move away from claims reporting, since approximately
69 percent of the Medicare Part B claims measures are topped out. This
is a contributing factor as to why we are looking to decrease the usage
of this option over time, as we have been signaling we would do for
many years. We will continue to work with stakeholders on providing
further transparency of the future of this collection type. It is
unclear to what reference the commenter is discussing where the removal
of claims reporting is a contradiction to provisions made in the
Bipartisan Budget Act of 2018. We do not believe that this proposal is
inconsistent with the Bipartisan Budget Act of 2018.
We do not believe further delay is warranted but will continue to
work with stakeholders to provide further clarity on the future of this
collection type. Lastly, we disagree that the expansion of the MIPS
eligible clinician type as discussed in section III.I.3.c. will
decrease the number of small practices. As defined at Sec. 414.1305, a
small practice is a TIN consisting of 15 or fewer eligible clinicians
during the MIPS determination period. We note that this definition
currently includes both eligible clinicians and MIPS eligible
clinicians, and therefore, the expansion of the MIPS eligible clinician
definition should not negatively impact a practice's ability to be
considered a small practice.
Comment: One commenter asked us to acknowledge that, from their
experiences participating in MIPS for the CY 2017 transition period,
when a group attests for promoting interoperability but uses Medicare
Part B claims to submit for the quality performance category as
individuals, every clinician must have quality data and this data does
not roll-up to the group.
Response: In the CY 2017 Quality Payment Program final rule (81 FR
77087 through 77088), Tables 1 and 2 summarized allowable individual
and group submission types. In the 2017 MIPS performance period,
Medicare Part B claims submissions for the quality performance category
could only be used by individuals, and no group score was calculated
for this collection type. In this final rule, we are finalizing our
proposal to allow small practices the option to report as individuals
or a group using Medicare Part B claims data so that a group
performance score can be calculated for quality and combined with other
group scores from other performance categories.
Comment: One commenter urged CMS to provide greater detail about
whether there is value in the data submitted through the Medicare Part
B claims measure collection type, given the reduced number of
clinically appropriate and applicable claims measures under Medicare
Part B, particularly considering data that is collected from claims
forms contains minimal clinical information.
Response: Medicare Part B Claims Measure Specifications do provide
value in the data submitted. Denominator eligibility can be determined
by billing already included within a Medicare Part B Claim. The
eligible clinician can submit a quality data code to attest to the
quality action defined by the measure specification. The Medicare Part
B Measure Specifications address a number of clinical outcomes on
prevalent health conditions (for example, diabetes, hypertension). In
addition to the outcomes, the Medicare Part B Claims Measure
Specifications provide eligible clinicians who provide services in a
small practice to participate within MIPS without incurring additional
costs in data abstraction by third party intermediaries.
Comment: One commenter urged CMS to provide greater detail about
whether small and rural practices who report their performance solely
through Medicare Part B claims measures would be afforded the
opportunity to submit fewer than 6 measures (including one outcome or
high priority measure) as currently required. This commenter also urged
CMS to provide greater detail about whether new Medicare Part B claims
quality measures would be accepted for inclusion in the rulemaking
process, or if only the current Medicare Part B claims quality measures
would be continued for use by small and rural practices.
Response: We did not propose any changes to the quality performance
submission criteria for the Medicare Part B claims collection type. We
validate the availability and applicability of quality measures for
clinicians who collect data via claims with fewer than six measures.
Clinicians would only need to report the measures that are applicable.
We refer readers to

[[Page 59752]]

section III.I.3.i.(1)(b)(vii) of this final rule for more discussion on
our data validation process. Any updates to the measures list would go
through future rulemaking. We want to clarify, that while reference was
made to both small and rural practices by the commenter, this policy is
limited to those that are small practices. We note that a practice that
is small and rural would be eligible to use the Medicare Part B claims
collection type, but only with meeting the special status designation
of being a small practice.
Comment: One commenter requested clarification on how CMS would
determine that a claims submission is intended for group reporting if
the group is only submitting data for the quality performance category
of MIPS.
Response: In the scenarios where we only receive Medicare Part B
claims submissions for a practice for the quality performance category
of MIPS, we intend on calculating the quality performance category for
the practice as both a group and as individuals and will apply the
quality performance category score that is the greater of the two. We
considered requiring an election for assessment as a group but believe
this would be unduly burdensome on small practices.
Comment: One commenter disagreed with our proposal to eliminate Web
Interface reporting for the improvement activities and Promoting
Interoperability performance categories, stating this reduces
flexibility for groups and adds unnecessary complexity.
Response: We clarify that the CMS Web Interface has been designed
as a method for quality submissions only, based on user feedback. As we
developed the CMS Web Interface for usage under the Quality Payment
Program, we engaged in user testing with stakeholders and the inclusion
of the improvement activities and promoting interoperability
performance categories within the CMS Web Interface tool negatively
impacted the design. Instead, what users experienced for submissions in
the first year of the program was a seamless interaction between the
CMS Web Interface and the ability to attest for these two performance
categories. With the finalization of this policy, users will have the
exact same experiences of reporting data for the promoting
interoperability and improvement activities performance categories
while still using the CMS Web Interface for the quality performance
category. We reiterate that we are simply updating our policy to
reflect the existing user experience that stakeholders encounter. We
would also like to highlight that groups that elect to utilize the CMS
Web Interface can still submit improvement activities or promoting
interoperability data via direct and log in and upload, if they choose
not to utilize the login and attest submission type.
Comment: One commenter supported our proposal to eliminate Web
Interface reporting for the improvement activities and Promoting
Interoperability performance categories.
Response: We appreciate the commenter's support.
Comment: One commenter appreciated that we clarified that groups
may submit their MIPS data for the improvement activities or Promoting
Interoperability performance categories using the direct, login and
upload, or login and attest submission types.
Response: Our intent was to provide clarity with the submission
experience for clinicians and other stakeholders.
Comment: A few commenters supported our proposal to allow third
party intermediaries to submit data using the CMS Web Interface on
behalf of groups, which alleviates burden on group practices to report
the data themselves.
Response: We appreciate the commenters' support.
After consideration of the public comments received, we are
finalizing our proposal to amend Sec. 414.1325(a) to incorporate Sec.
414.1325(e), as they both address which performance categories require
data submission; Sec. 414.1325(f) will be redesignated as Sec.
414.1325(e). We are finalizing our proposal at Sec. 414.1325(a)(2)(ii)
that there is no data submission requirement for the quality or cost
performance category, as applicable, for MIPS eligible clinicians and
groups that are scored under the facility-based measurement scoring
methodology described in Sec. 414.1380(e). We are finalizing our
proposals to reorganize Sec. 414.1325(b) and (c) by performance
category and to clarify at Sec. 414.1325(b)(1) that an individual MIPS
eligible clinician may submit their MIPS data for the quality
performance category using the direct, login and upload, and Medicare
Part B claims submission types. We are finalizing our proposal to
clarify at Sec. 414.1325(b)(2) that an individual MIPS eligible
clinician may submit their MIPS data for the improvement activities or
Promoting Interoperability performance categories using the direct,
login and upload, or login and attest submission types. We are
finalizing our proposal to clarify at Sec. 414.1325(c)(1) that groups
may submit their MIPS data for the quality performance category using
the direct, login and upload, and CMS Web Interface (for groups
consisting of 25 or more eligible clinicians) submission types. We are
also finalizing our proposal to clarify at Sec. 414.1325(c)(2) that
groups may submit their MIPS data for the improvement activities or
Promoting Interoperability performance categories using the direct,
login and upload, or login and attest submission types. We are
finalizing our proposal to amend Sec. 414.1325(c)(1) to make the
Medicare Part B claims collection type available to MIPS eligible
clinicians in small practices beginning with the 2021 MIPS payment
year. We are finalizing our proposal at Sec. 414.1325(c)(2) to state
that the CMS Web Interface submission type will no longer be available
for groups to use to submit data for the improvement activities and
Promoting Interoperability performance categories. We are finalizing
our proposal to redesignate Sec. 414.1325(c)(4) as Sec.
414.1325(c)(1) and amend Sec. 414.1325(c)(1) to allow third party
intermediaries to submit data using the CMS Web Interface on behalf of
groups. We are finalizing our proposal to redesignate Sec.
414.1325(f)(2) as Sec. 414.1325(e)(2) that for Medicare Part B claims,
data must be submitted on claims with dates of service during the
performance period that must be processed no later than 60 days
following the close of the performance period. Lastly, we are also
finalizing our proposal to amend Sec. 414.1325(a)(2)(i) to reflect
that claims included in the measures are those submitted with dates of
service during the performance period that are processed no later than
60 days following the close of the performance period. We received many
comments on our comment solicitation to expand the scope of practices
that can utilize the Web Interface and will take them into
consideration for future rulemaking.

[[Page 59753]]

Table 32--Data Submission Types for MIPS Eligible Clinicians Reporting as Individuals
----------------------------------------------------------------------------------------------------------------
Performance category/submission
combinations accepted Submission type Submitter type Collection type
----------------------------------------------------------------------------------------------------------------
Quality.............................. Direct................. Individual or Third eCQMs.
Log in and upload...... Party Intermediary \2\. MIPS CQMs.
Medicare Part B claims Individual............. QCDR measures.
(small practices) \1\.. Medicare Part B claims
measures (small
practices).
Cost................................. No data submission Individual .......................
required \2\.
Promoting Interoperability........... Direct................. Individual or Third .......................
Log in and upload...... Party Intermediary.
Log in and attest......
Improvement Activities............... Direct................. Individual or Third .......................
Log in and upload...... Party Intermediary.
Log in and attest......
----------------------------------------------------------------------------------------------------------------
\1\ Third party intermediary does not apply to Medicare Part B claims submission type.
\2\ Requires no separate data submission to CMS: Measures are calculated based on data available from MIPS
eligible clinicians' billings on Medicare claims. Note: As used in this rule, the term ``Medicare Part B
claims'' differs from ``administrative claims'' in that ``Medicare Part B claims'' require MIPS eligible
clinicians to append certain billing codes to denominator-eligible claims to indicate the required quality
action or exclusion occurred.

Table 33--Data Submission Types for MIPS Eligible Clinicians Reporting as Groups
----------------------------------------------------------------------------------------------------------------
Performance category/submission
combinations accepted Submission types Submitter type Collection type
----------------------------------------------------------------------------------------------------------------
Quality.............................. Direct................. Group or Third Party eCQMs.
Log in and upload...... Intermediary. MIPS CQMs.
CMS Web Interface QCDR measures.
(groups of 25 or more CMS Web Interface
eligible clinicians).. measures.
Medicare Part B claims Medicare Part B claims
(small practices) \1\.. measures (small
practices).
CMS approved survey
vendor measure.
Administrative claims
measures.
Cost................................. No data submission Group .......................
required 1 2.
Promoting Interoperability........... Direct................. Group or Third Party .......................
Log in and upload...... Intermediary
Log in and attest......
Improvement Activities............... Direct................. Group or Third Party .......................
Log in and upload...... Intermediary
Log in and attest......
----------------------------------------------------------------------------------------------------------------
\1\ Third party intermediary does not apply to Medicare Part B claims submission type.
\2\ Requires no separate data submission to CMS: Measures are calculated based on data available from MIPS
eligible clinicians' billings on Medicare claims. Note: As used in this rule, the term ``Medicare Part B
claims'' differs from ``administrative claims'' in that ``Medicare Part B claims'' require MIPS eligible
clinicians to append certain billing codes to denominator-eligible claims to indicate the required quality
action or exclusion occurred.

(d) Submission Deadlines
We previously finalized data submission deadlines in the CY 2017
Quality Payment Program final rule (81 FR 77095 through 77097) at Sec.
414.1325(f), which outlined data submission deadlines for all
submission mechanisms for individual eligible clinicians and groups for
all performance categories. As discussed in section III.I.3.h.(1) of
this final rule, the term submission mechanism, that includes
submission via the qualified registry, QCDR, EHR, Medicare Part B
claims, the CMS Web Interface and attestation, does not align with the
existing process of data submission to the Quality Payment Program. In
the CY 2019 PFS proposed rule (83 FR 35896), we proposed to revise
regulatory text language at Sec. 414.1325(f), which, as noted, we
proposed to redesignate as Sec. 414.1325(e), to outline data
submission deadlines for all submission types for individual eligible
clinicians and groups for all performance categories. In the CY 2019
PFS proposed rule (83 FR 35896), we also proposed to revise Sec.
414.1325(e)(1) to allow flexibility for CMS to alter submission
deadlines for the direct, login and upload, the CMS Web Interface, and
login and attest submission types. We anticipate that in scenarios
where the March 31st deadline falls on a weekend or holiday, we will
extend the submission period to the next business day (that is,
Monday). There also may be instances where due to unforeseen technical
issues, the submission system may be inaccessible for a period of time.
If this scenario were to occur, we anticipate that we will extend the
submission period to account for this lost time, to the extent
feasible. We note that this revision would also revise the previously
finalized policy at Sec. 414.1325(e)(3) stating that data must be
submitted during an 8-week period following the close of the
performance period, and that the period must begin no earlier than
January 2 and end no later than March 31 for the CMS Web Interface. In
the CY 2019 PFS proposed rule (83 FR 35896), we proposed to align the
deadline for the CMS Web Interface submission type with all other
submission type deadlines at Sec. 414.1325(e)(1), while we also
proposed to remove the previously finalized policy at Sec.
414.1325(e)(3) because it is no longer needed to mandate a different
submission

[[Page 59754]]

deadline for the CMS Web Interface submission type. In the CY 2019 PFS
proposed rule (83 FR 35896), we also proposed a number of other
technical revisions to Sec. 414.1325 to more clearly and concisely
reflect previously established policies.
The following is a summary of the comments we received on
``Submission Deadlines''.
Comment: Several commenters supported our proposal to align the
deadline for the CMS Web Interface submission type with all other
submission type deadlines and appreciated further aligning deadlines
within the program, stating that predictable and achievable deadlines
are preferred for planning and education purposes. Another commenter
urged us to make this new deadline clear to physicians by emphasizing
the different deadlines at the start of the performance year.
Response: We will take all feedback into consideration for future
educational materials.
Comment: One commenter opposed our proposal to align the deadline
for the CMS Web Interface submission type with all other submission
type deadlines, stating that this flexibility is being used to shorten
the deadline, and that the earliest deadline should be set at March 31.
Response: We disagree that this flexibility is being used to
shorten the deadline. We clarify that it is no longer necessary to
mandate a different submission deadline for the CMS Web Interface
submission type and this proposal will bring further alignment amongst
submission types. Furthermore, this policy extends the CMS Web
Interface submission deadline by approximately 4 additional weeks.
After consideration of the public comments received, we are
finalizing our proposal to redesignate Sec. 414.1325(f) as Sec.
414.1325(e), to outline data submission deadlines for all submission
types for individual eligible clinicians and groups for all performance
categories. We are finalizing our proposal to revise Sec.
414.1325(e)(1) to allow flexibility for CMS to alter submission
deadlines for the direct, login and upload, the CMS Web Interface, and
login and attest submission types. We are also finalizing our proposals
to align the deadline for the CMS Web Interface submission type with
all other submission type deadlines at Sec. 414.1325(e)(1), and to
remove the previously finalized policy at Sec. 414.1325(e)(3) because
it is no longer needed to mandate a different submission deadline for
the CMS Web Interface submission type.
(2) Quality Performance Category
(a) Background
We refer readers to Sec. Sec. 414.1330 through 414.1340 and the CY
2018 Quality Payment Program final rule (82 FR 53626 through 53641) for
our previously established policies regarding the quality performance
category.
(i) Assessing Performance on the Quality Performance Category
As discussed in the CY 2019 PFS proposed rule (83 FR 35896), under
Sec. 414.1330(a), for purposes of assessing performance of MIPS
eligible clinicians on the quality performance category, we will use:
Quality measures included in the MIPS final list of quality measures;
and quality measures used by QCDRs. We proposed to amend Sec.
414.1330(a) to account for facility-based measurement and the APM
scoring standard. For that reason, we proposed at Sec. 414.1330(a) to
specify, for a MIPS payment year, that we use the following quality
measures, as applicable to assess performance in the quality
performance category: Measures included in the MIPS final list of
quality measures established by CMS through rulemaking; QCDR measures
approved by CMS under Sec. 414.1440; facility-based measures as
described under Sec. 414.1380; and MIPS APM measures as described at
Sec. 414.1370.
We did not receive any comments on the proposal of how we will
assess performance in the quality performance category. Therefore, we
are finalizing our proposal to amend Sec. 414.1330(a) to state that
for a MIPS payment year, we use the following quality measures, as
applicable, to assess performance in the quality performance category:
Measures included in the MIPS final list of quality measures
established by CMS through rulemaking; QCDR measures approved by CMS
under Sec. 414.1440; facility-based measures as described in Sec.
414.1380; and MIPS APM measures as described in Sec. 414.1370.
(ii) Contribution to Final Score
In the CY 2019 PFS proposed rule (83 FR 35896) under Sec.
414.1330(b)(2) and (3), we state that performance in the quality
performance category will comprise 50 percent of a MIPS eligible
clinician's final score for the 2020 MIPS payment year and 30 percent
of a MIPS eligible clinician's final score for each MIPS payment year
thereafter. Section 1848(q)(5)(E)(i)(I) of the Act, as amended by
section 51003(a)(1)(C)(i) of the Bipartisan Budget Act of 2018,
provides that 30 percent of the final score shall be based on
performance with respect to the quality performance category, but that
for each of the 1st through 5th years for which MIPS applies to
payments, the quality performance category performance percentage shall
be increased so that the total percentage points of the increase equals
the total number of percentage points that is based on the cost
performance category performance is less than 30 percent for the
respective year. As discussed in section III.I.3.i.(c) of this final
rule, we proposed to weight the cost performance category at 15 percent
for the 2021 MIPS payment year. Accordingly, we proposed to amend Sec.
414.1330(b)(2) to provide that performance in the quality performance
category will comprise 50 percent of a MIPS eligible clinician's final
score for the 2020 MIPS payment year, and proposed at Sec.
414.1330(b)(3) that the quality performance category comprises 45
percent of a MIPS eligible clinician's final score for the 2021 MIPS
payment year.
We received the following comments on our proposals regarding the
quality performance category's contribution to the final score
proposal:
Comment: A few commenters supported our proposals.
Response: We thank the commenters for their support.
Comment: Several commenters did not support the proposed reduction
of the quality performance category weight to 45 percent from 50
percent for the 2021 MIPS payment year, suggesting that CMS maintain
the weight at 50 percent. The commenters indicated that adjusting the
weight downward sends the wrong message to physicians regarding quality
of care and that de-emphasizing quality runs contrary to the aim of
reforming toward a value-based system. Further, commenters stated that
altering the weight prematurely leads to less stability with the
program and adds complexity. A few commenters recommended that we
transfer the weight from the improvement activity category as needed to
preserve the weight of the quality category.
Response: As discussed in section III.I.3.h.(3) of this final rule,
we are finalizing the proposal to weight the cost performance category
at 15 percent for the 2021 MIPS payment year. Accordingly, section
1848(q)(5)(E)(i)(1) of the Act requires that the quality performance
category weight to be 45 percent. While we understand that the quality
performance category requires additional resources to report, we
believe that we are measuring value by rewarding performance in quality
while keeping down costs and that clinicians can influence the cost of
services that they do not personally perform by

[[Page 59755]]

improving care management with other clinicians and avoiding
unnecessary services. Regarding the commenters' recommendation that we
reduce the weight of the improvement activities performance category to
preserve the weight of the quality performance category, we note that
we do not have discretion to reduce the weight of the improvement
activities performance category except for scenarios where reweighting
can occur due to measures and activities and not being available and
applicable. Please refer to section III.I.3.i.(1)(e) for information on
our reweighting policies.
As discussed in section III.I.3.h.(3) of this final rule, we are
finalizing our proposal to weight the cost performance category at 15
percent for the 2021 MIPS payment year. After consideration of the
public comments received, we are finalizing our proposal to amend Sec.
414.1330(b)(2) to provide that performance in the quality performance
category comprises 50 percent of a MIPS eligible clinician's final
score for the 2020 MIPS payment year, and our proposal to amend Sec.
414.1330(b)(3) to provide that the quality performance category
comprises 45 percent of a MIPS eligible clinician's final score for the
2021 MIPS payment year.
(iii) Quality Data Submission Criteria
(A) Submission Criteria
(aa) Submission Criteria for Groups Reporting Quality Measures,
Excluding CMS Web Interface Measures and the CAHPS for MIPS Survey
Measure
In the CY 2019 Quality Payment Program proposed rule (83 FR 35896
through 35897), we referred readers to Sec. 414.1335(a)(1) for our
previously established submission criteria for quality measures
submitted via claims, registry, QCDR, or EHR. As discussed in section
III.I.3.h. of this final rule, we proposed revisions to existing and
additional terminology to clarify the data submission processes
available for MIPS eligible clinicians, groups and third party
intermediaries, to align with the way users actually submit data to the
Quality Payment Program. For that reason, we proposed to revise Sec.
414.1335(a)(1) to state that data would be collected for the following
collection types: Medicare Part B claims measures; MIPS CQMs; eCQMs; or
QCDR measures. Codified at Sec. 414.1335(a)(1)(i), MIPS eligible
clinicians and groups must submit data on at least six measures
including at least one outcome measure. If an applicable outcome
measure is not available, eligible clinicians and groups must report
one other high priority measure. If fewer than six measures apply to
the MIPS eligible clinician or group, they must report on each measure
that is applicable. Furthermore, we proposed beginning with the 2021
MIPS payment year to revise Sec. 414.1335(a)(1)(ii) to indicate that
MIPS eligible clinicians and groups that report on a specialty or
subspecialty measure set, must submit data on at least six measures
within that set, provided the set contain at least six measures. If the
set contains fewer than six measures or if fewer than six measures
apply to the MIPS eligible clinician or group, they must report on each
measure that is applicable.
As previously expressed in the 2017 Quality Payment Program final
rule (81 FR 77090), we want to move away from claims reporting, since
approximately 69 percent of the Medicare Part B claims measures are
topped out. As discussed in section III.I.3.h. of this final rule, we
proposed to limit the Medicare Part B claims submission type, and
therefore, the Medicare Part B claims measures, to MIPS eligible
clinicians in small practices. We refer readers to section III.I.3.h of
this final rule for discussion of this proposal.
The following is a summary of the public comments on these
proposals and our responses:
Comment: A few commenters did not support the proposed specialty or
subspecialty measure set submission criteria, citing the potential
difficulty in reporting measures within the set that are not
applicable. One commenter requested that, if the proposal is finalized,
CMS should clarify how the requirement applies when clinicians submit
both MIPS CQMs and QCDR measures to meet the quality performance
category requirements, recognizing that some eligible clinicians may
not be able to meet the requirement to report on all measures within a
specialty or subspecialty set. Another commenter recommended that CMS
revise its data submission criteria pertaining to specialty and
subspecialty measure sets and require clinicians to report at least one
outcome or high priority measure.
Response: To clarify, should a MIPS eligible clinician choose to
report on a specialty or a subspecialty measure set, they are only
required to submit data on six measures within that set, provided the
set contain at least six measures. If the set contains fewer than six
measures or if fewer than six measures apply to the MIPS eligible
clinician or group, they are required to report on each measure that is
applicable. If a MIPS eligible clinician chooses to report only on a
specialty or subspecialty measure set and reports on less than 6
quality measures through either the MIPS CQM or Medicare Part B claims
collection types, they will be subjected to the measure validation
process that will validate whether the clinician actually had less than
6 measures available or applicable to their scope of practice. If a
MIPS eligible clinician chooses to report via the QCDR measure
collection type, they will be required to meet the reporting
requirement of 6 quality measures. If a MIPS eligible clinician reports
fewer than 6 quality measures through a QCDR, they will receive zero
points for each unreported quality measure. As stated at revised Sec.
414.1335(a)(1)(ii), MIPS eligible clinicians are required to report at
least one outcome measure, or if no outcome measures are available or
applicable, report another high priority measure in lieu of an outcome
measure.
Comment: One commenter sought clarification on the proposed
specialty or subspecialty measure set submission criteria.
Specifically, the commenter questioned what a MIPS eligible clinician
or group is required to do if fewer than 6 measures apply to the MIPS
eligible clinician within their specialty or sub-specialty domain.
Additionally, the commenter requested clarification on whether outcome
measures or high-priority measures for specialty sets were required.
Response: The clinician is required to report at least one outcome
measure or, if an applicable outcome measure is not available, one
other high priority measure. If a MIPS eligible clinician chooses to
report on a specialty or subspecialty measure set, the set contains at
least 6 quality measures, and the clinician reports on fewer than 6
measures through the MIPS CQM or Medicare Part B claims collection
type, the clinician will be subjected to the measure validation
process, which will validate whether fewer than 6 measures were
actually available and applicable to their scope of practice. If the
measure validation process determines that at least 6 measures were
available and applicable to the clinician's scope of practice, they
will receive zero points for each unreported measure. We refer readers
to Appendix 1: Finalized MIPS Quality Measures in this final rule,
where the specialty sets are finalized in Table Group B. There are high
priority measures available in all the specialty sets, and therefore a
MIPS eligible clinician should be able to select a specialty set that
reflects their scope of practice, and be able to report on the measures
within that set, including the high-priority measures.

[[Page 59756]]

After consideration of the public comments received, we are
finalizing our proposal to amend Sec. 414.1335(a)(1) to state that
data would be collected for the following collection types: Medicare
Part B claims measures; MIPS CQMs; eCQMs; or QCDR measures. Codified at
Sec. 414.1335(a)(1)(i), MIPS eligible clinicians and groups must
submit data on at least six measures including at least one outcome
measure. If an applicable outcome measure is not available, they must
report one other high priority measure. If fewer than six measures
apply to the MIPS eligible clinician or group, report on each measure
that is applicable. We are also finalizing our proposal to amend Sec.
414.1335(a)(1)(ii) to state that MIPS eligible clinicians and groups
that report on a specialty or subspecialty measure set, must submit
data on at least six measures within that set, provided the set
contains at least six measures. If the set contains fewer than six
measures or if fewer than six measures apply to the MIPS eligible
clinician or group, they must report on each measure that is
applicable.
(bb) Submission Criteria for Groups Reporting CMS Web Interface
Measures
As noted in the CY 2019 PFS proposed rule (83 FR 35897), we did not
propose any changes to the established submission criteria for CMS Web
Interface measures. For purposes of clarity and organization, we are
finalizing a technical change by moving the regulation text on the
sampling requirements for reporting CMS Web Interface measures from
Sec. 414.1335(a)(2) to Sec. 414.1340(c)(1). However, beginning with
the 2021 MIPS payment year, we proposed to revise the terminology with
which CMS Web Interface measures are referenced-to align with the
updated submission terminology as discussed in section III.I.3.h. of
this final rule. Therefore, we proposed to revise Sec. 414.1335(a)(2)
from ``via the CMS Web Interface-for groups consisting of 25 or more
eligible clinicians only'', to ``for CMS Web Interface measures''.
In order to ensure that the collection of information is valuable
to clinicians and worth the cost and burden of collecting information,
and address the challenge of fragmented reporting for multiple measures
and submission options, we solicited comment on expanding the CMS Web
Interface option to groups with 16 or more eligible clinicians.
Preliminary analysis has indicated that expanding the CMS Web Interface
option to groups of 16 or more eligible clinicians would likely result
in many of these new groups not being able to fully satisfy measure
case minimums on multiple CMS Web Interface measures. However, we could
possibly mitigate this issue if we require smaller groups (with 16-24
eligible clinicians) to report on only a subset of the CMS Web
Interface measures, such as the preventive care measures. We solicited
stakeholder feedback on the issue of expanding the CMS Web interface to
groups of 16 or more, as well as other factors we should consider with
such expansion. We received comments from stakeholders regarding
expanding the CMS Web Interface option to groups with 16 or more
eligible clinicians. We thank commenters for their input and may take
this input into consideration in future years.
As discussed in section III.F.1.c. of this final rule, changes
proposed and finalized through rulemaking to the CMS Web Interface
measures for MIPS would be applicable to ACO quality reporting under
the Shared Savings Program. As discussed in Table Group D: Measures
with Substantive Changes Proposed for the 2021 MIPS Payment Year and
Future Years of the measures appendix of this final rule, we proposed
to remove 6 measures from the CMS Web Interface in MIPS. If finalized,
groups reporting CMS Web Interface measures for MIPS would not be
responsible for reporting those removed measures. We refer readers to
the quality measure appendix for additional details on the proposals
related to changes in CMS Web Interface measures.
As discussed in the CY 2017 Quality Payment Program final rule (81
FR 77116), the CMS Web Interface has a two-step attribution process
that associates beneficiaries with TINs during the period in which
performance is assessed (adopted from the Physician Value-based Payment
Modifier (VM) program). The CAHPS for MIPS survey utilizes the same
two-step attribution process as the CMS Web Interface. The CY 2017
Quality Payment Program final rule (81 FR 77116) noted that attribution
would be conducted using the different identifiers in MIPS. For
purposes of the CMS Web Interface and the CAHPS for MIPS survey, we
clarified that attribution would be conducted at the TIN level (83 FR
35897).
We did not receive comments on the proposal to revise Sec.
414.1335(a)(2) from ``via the CMS Web Interface-for groups consisting
of 25 or more eligible clinicians only'', to ``for CMS Web Interface
measures''.
We are finalizing revisions to Sec. 414.1335(a)(2) to state that
via the CMS Web Interface measures- for groups consisting of 25 or more
eligible clinicians only, groups must report on all measure included in
the CMS Web Interface. The group must report on the first 248
consecutively ranked beneficiaries in the sample for each module.
(cc) Submission Criteria for Groups Electing to Report Consumer
Assessment of Healthcare Providers and Systems (CAHPS) for MIPS Survey
As noted in the CY 2019 PFS proposed rule (83 FR 35897), we did not
propose any changes to the established submission criteria for the
CAHPS for MIPS Survey at Sec. 414.1335(a)(3). However, beginning with
the 2021 MIPS payment year, we proposed to revise Sec. 414.1335(a)(3)
to clarify for the CAHPS for MIPS survey, for the 12-month performance
period, a group that wishes to voluntarily elect to participate in the
CAHPS for MIPS survey measure must use a survey vendor that is approved
by CMS for the applicable performance period to transmit survey measure
data to us.
We did not receive comments on the proposal to clarify the
requirement to use a CMS approved CAHPS for MIPS survey vendor.
We are finalizing our proposal to amend Sec. 414.1335(a)(3) to
clarify for the CAHPS for MIPS survey that beginning with the 2021 MIPS
payment year, for the 12-month performance period, a group that wishes
to voluntarily elect to participate in the CAHPS for MIPS survey
measure must use a survey vendor that is approved by CMS for the
applicable performance period to transmit survey measure data to us.
(B) Summary of Data Submission Criteria
In the CY 2019 PFS proposed rule (83 FR 35897), we did not propose
any changes to the quality data submission criteria for the 2021 MIPS
payment year; however, as discussed in section III.I.3.h. of this final
rule, we proposed changes to existing and additional submission related
terminology. Similarly, although we did not propose changes to the data
completeness criteria at Sec. 414.1340, we proposed changes to
existing and additional submission related terminology. For that
reason, we proposed to revise Sec. 414.1340 to specify that MIPS
eligible clinicians and groups submitting quality measures data on QCDR
measures, MIPS CQMs, or eCQMs must submit data on at least 60 percent
of the MIPS eligible clinician or group's patients that meet the
measure's denominator criteria, regardless of payer for MIPS payment
year 2021; MIPS eligible clinicians and groups submitting quality
measure data

[[Page 59757]]

on the Medicare Part B claims measures must submit data on at least 60
percent of the applicable Medicare Part B patients seen during the
performance period to which the measure applies for the 2021 MIPS
payment year; and groups submitting quality measures data on CMS Web
Interface measures or the CAHPS for MIPS survey measure, must meet the
data submission requirement on the sample of the Medicare Part B
patients CMS provides. Tables 34 and 35 clearly capture the data
completeness requirements and submission criteria by collection type
for individual clinicians and groups.

Table 34--Summary of Data Completeness Requirements and Performance
Period by Collection Type for the 2020 and 2021 MIPS Payment Years
------------------------------------------------------------------------
Performance
Collection type period Data completeness
------------------------------------------------------------------------
Medicare Part B claims Jan 1-Dec 31..... 60 percent of
measures. individual MIPS
eligible
clinician's, or
group's Medicare
Part B patients for
the performance
period.
Administrative claims measures Jan 1-Dec 31..... 100 percent of
individual MIPS
eligible clinician's
Medicare Part B
patients for the
performance period.
QCDR measures, MIPS CQMs, and Jan 1-Dec 31..... 60 percent of
eCQMs. individual MIPS
eligible
clinician's, or
group's patients
across all payers
for the performance
period.
CMS Web Interface measures.... Jan 1-Dec 31..... Sampling requirements
for the group's
Medicare Part B
patients: Populate
data fields for the
first 248
consecutively ranked
and assigned
Medicare
beneficiaries in the
order in which they
appear in the
group's sample for
each module/measure.
If the pool of
eligible assigned
beneficiaries is
less than 248, then
the group would
report on 100
percent of assigned
beneficiaries.
CAHPS for MIPS survey measure. Jan 1-Dec 31..... Sampling requirements
for the group's
Medicare Part B
patients.
------------------------------------------------------------------------

Table 35--Summary of Quality Data Submission Criteria for MIPS Payment
Year 2020 and 2021 for Individual Clinicians and Groups
------------------------------------------------------------------------
Measure collection
Clinician type Submission criteria types (or measure
sets) available
------------------------------------------------------------------------
Individual Clinicians....... Report at least six Individual MIPS
measures including eligible clinicians
one outcome select their
measure, or if an measures from the
outcome measure is following
not available collection types:
report another high Medicare Part B
priority measure; claims measures
if less than six (individual
measures apply then clinicians in small
report on each practices only),
measure that is MIPS CQMs, QCDR
applicable. measures, eCQMs, or
Clinicians would reports on one of
need to meet the the specialty
applicable data measure sets if
completeness applicable.
standard for the
applicable
performance period
for each collection
type.
Groups (non-CMS Web Report at least six Groups select their
Interface). measures including measures from the
one outcome following
measure, or if an collection types:
outcome measure is Medicare Part B
not available claims measures
report another high (small practices
priority measure; only), MIPS CQMs,
if less than six QCDR measures,
measures apply then eCQMs, or the CAHPS
report on each for MIPS survey--or
measure that is reports on one of
applicable. the specialty
Clinicians would measure sets if
need to meet the applicable.
applicable data Groups of 16 or more
completeness clinicians who meet
standard for the the case minimum of
applicable 200 will also be
performance period automatically
for each collection scored on the
type. administrative
claims based all-
cause hospital
readmission
measure.
Groups (CMS Web Interface Report on all Groups report on all
for group of at least 25 measures includes measures included
clinicians). in the CMS Web in the CMS Web
Interface Interface measures
collection type and collection type and
optionally the optionally the
CAHPS for MIPS CAHPS for MIPS
survey. Clinicians survey.
would need to meet Groups of 16 or more
the applicable data clinicians who meet
completeness the case minimum of
standard for the 200 will also be
applicable automatically
performance period scored on the
for each collection administrative
type. claims based all-
cause hospital
readmission
measure.
------------------------------------------------------------------------

We received comments on the proposal to revise Sec. 414.1340 to
specify that MIPS eligible clinicians and groups submitting quality
measures data must submit data on at least 60 percent of the MIPS
eligible clinician or group's patients that meet the measure's
denominator criteria, regardless of payer for MIPS payment year 2021:
Comment: One commenter requested that CMS clarify the 90-day
performance period mentioned in Table 31 of the proposed rule. This
commenter requested more information concerning to which measures the
performance period would apply and expressed concerns about the
differing performance period for measures.
Response: We clarify that in the CY 2019 PFS proposed rule (83 FR
35898), the reference in Table 31 to a 90-day performance period for
certain measures was an inadvertent error. To clarify, there is no 90-
day performance period for any MIPS quality measure. For the 2020 and
2021 MIPS payment years, the performance period is 12 months. Table 34
Summary of Data Completeness Requirements and Performance Period by
Collection Type for the 2020 and 2021 MIPS Payment Years has been
updated to reflect this correction.
Comment: One commenter opposed a full calendar-year performance
period given the proposed 60 percent data completion requirement for
the quality performance category and the potential burden in developing
and implementing new applicable measures.
Response: While the data completeness requirement will remain at 60
percent for the 2019 performance

[[Page 59758]]

period, we have previously noted our interest in incorporating higher
data completeness thresholds in future years to ensure a more accurate
assessment of a MIPS eligible clinician's performance on quality
measures and to avoid measure selection bias as much as possible, but
believe it should be done so in a gradual manner. In the CY 2019 PFS
proposed rule (83 FR 35893), we noted our belief that a full calendar
year performance period for the quality and cost performance categories
will be less confusing for MIPS eligible clinicians. A longer
performance period for quality will likely include more patient
encounters, which will increase the denominator of the quality measures
reported. Statistically, a larger sample size provides more accurate
and actionable information. Furthermore, a full calendar year
performance period is consistent with how many of the measures used in
our program were designed to be performed and reported.
Comment: A few commenters supported the fact that our proposal to
maintain the 60 percent data completeness threshold and encouraged CMS
to retain this policy for future program years.
Response: We thank the commenters for their support.
Comment: One commenter recommended that CMS increase the data
completeness threshold to 100 percent. Other commenters noted that
because calculating and submitting an accurate reporting rate requires
an analysis of a full set of data and is often a manual and error-prone
process, they do not believe it significantly reduces provider burden
to have a 60 percent data completeness threshold as compared to 100
percent.
Response: As discussed in the CY 2018 Quality Payment Program final
rule (82 FR 53632), we noted concerns about the unintended consequences
of accelerating the data completeness threshold so dramatically, which
may jeopardize a MIPS eligible clinician's ability to participate and
perform well in MIPS, particularly with those clinicians who are not as
experienced with MIPS quality measure submission. While we do continue
to monitor the data completeness threshold with future intentions of
raising the threshold for data completeness, we want to ensure that the
data completeness requirement is achievable by all MIPS eligible
clinicians. We do agree that it is important to incorporate higher data
completeness thresholds in future years to ensure a more accurate
assessment of a MIPS eligible clinician's performance on quality
measures and to avoid measure selection bias as much as possible, but
believe it should be done so in a gradual manner.
Comment: One commenter requested clarification on whether the data
completeness criteria is 60 percent of the performance year, regardless
of time, or if MIPS eligible clinicians are mandated to include 60
percent of their patient data from the calendar year.
Response: As stated at Sec. 414.1340(b)(2), MIPS eligible
clinicians are required to submit data on at least 60 percent of the
applicable Medicare Part B patients seen during the performance period,
as illustrated in Table 34.
Comment: One commenter expressed support for updating the
terminology of the data completeness criteria, stating that it does not
change the data completeness criteria from the previous years.
Response: We thank the commenter for their support. We clarify that
we did not make any proposals or changes to the data completeness
criteria, and only made changes to existing and additional submission
related terminology, as explained in the CY 2019 PFS proposed rule (83
FR 35897).
After consideration of the public comments received, we are
finalizing revisions to Sec. 414.1340 to specify that MIPS eligible
clinicians and groups submitting quality measures data on QCDR
measures, MIPS CQMs, or the eCQMs must submit data on at least 60
percent of the MIPS eligible clinician or group's patients that meet
the measure's denominator criteria, regardless of payer for MIPS
payment year 2021; MIPS eligible clinicians and groups submitting
quality measure data on the Medicare Part B claims measures must submit
data on at least 60 percent of the applicable Medicare Part B patients
seen during the performance period to which the measure applies for the
2021 MIPS payment year; and groups submitting quality measures data on
CMS Web Interface measures or the CAHPS for MIPS survey measure, must
meet the data submission requirement on the sample of the Medicare Part
B patients CMS provides, as applicable.
(iv) Application of Facility-Based Measures
Under section 1848(q)(2)(C)(ii) of the Act, the Secretary may use
measures for payment systems other than for physicians, such as
measures used for inpatient hospitals, for purposes of the quality and
cost performance categories. However, the Secretary may not use
measures for hospital outpatient departments, except in the case of
items and services furnished by emergency physicians, radiologists, and
anesthesiologists. We refer readers to section III.I.3.i.(1)(d) of this
final rule for a full discussion of facility-based measures and scoring
for the 2021 MIPS payment year.
(b) Selection of MIPS Quality Measures for Individual MIPS Eligible
Clinicians and Groups Under the Annual List of Quality Measures
Available for MIPS Assessment
(i) Background and Policies for the Call for Measures and Measure
Selection Process
In the CY 2019 PFS proposed rule (83 FR 35898 through 35899), we
noted that developed and announced our Meaningful Measures
Initiative.\18\ By identifying the highest priority areas for quality
measurement and quality improvement, the Meaning Measures Initiative
identifies the core quality of care issues that advances our work to
improve patient outcomes. Through subregulatory guidance, we will
categorize quality measures by the 19 Meaningful Measure areas as
identified on the Meaningful Measures Initiative website at https://
www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-
Instruments/QualityInitiativesGenInfo/MMF/General-info-Sub-Page.html.
The categorization of quality measures by Meaningful Measure area would
provide MIPS eligible clinicians and groups with guidance as to how
each measure fits into the framework of the Meaningful Measure
Initiative.
---------------------------------------------------------------------------

\18\ Link to Meaningful Measures web page on CMS site to be
provided at https://www.cms.gov/Medicare/Quality-Initiatives-
Patient-Assessment-Instruments/QualityInitiativesGenInfo/MMF/
General-info-Sub-Page.html.
---------------------------------------------------------------------------

Furthermore, under Sec. 414.1305, a high priority measure is
defined as an outcome, appropriate use, patient safety, efficiency,
patient experience or care coordination quality measure. Due to the
immense impact of the opioid epidemic across the United States, we
believe it is imperative to promote the measurement of opioid use and
overuse, risks, monitoring, and education through quality reporting.
For that reason, beginning with the 2019 performance period, we
proposed at Sec. 414.1305 to amend the definition of a high priority
measure to include quality measures that relate to opioids and to
further clarify the types of outcome measures that are considered high
priority. Beginning with the 2021 MIPS payment year, we proposed to
define at Sec. 414.1305 a high priority measure to mean an outcome,
appropriate use, patient safety, efficiency, patient experience, care
coordination, or

[[Page 59759]]

opioid-related quality measure. Outcome measures would include
intermediate-outcome and patient-reported outcome measures. We
requested comment on this proposal, specifically if stakeholders have
suggestions on what aspects of opioids should be measured--for example,
whether we should focus solely on opioid overuse. We summarize and
respond to the comments received on this proposal below.
Previously finalized MIPS quality measures can be found in the CY
2018 Quality Payment Program final rule (82 FR 53966 through 54174) and
in the CY 2017 Quality Payment Program final rule (81 FR 77558 through
77816). The new MIPS quality measures finalized for inclusion in MIPS
for the 2019 performance period and future years are found in Table
Group A of the ``Appendix 1: Finalized MIPS Quality Measures'' of this
final rule. The current specialty measure sets can be found in the CY
2018 Quality Payment Program final rule (82 FR 53976 through 54146).
The finalized new and modified quality measure specialty sets can be
found in Table Group B of the ``Appendix 1: Finalized MIPS Quality
Measures'' of this final rule and include new measures, previously
finalized measures with modifications, and previously finalized
measures with no modifications.
We note that modifications made to the specialty sets may include
the removal of certain previously finalized quality measures. Certain
MIPS specialty sets have further defined subspecialty sets, each of
which constitutes a separate specialty set. In instances where an
individual MIPS eligible clinician or group reports on a specialty or
subspecialty set, if the set has less than six measures, that is all
the clinician is required to report. MIPS eligible clinicians are not
required to report on the specialty measure sets, but they are
suggested measures for specific specialties. Please note that the
finalized specialty and subspecialty sets are not inclusive of every
specialty or subspecialty.
On January 9, 2018,\19\ we announced that we would be accepting
recommendations for potential new specialty measure sets for Year 3 of
MIPS under the Quality Payment Program. These recommendations were
based on the MIPS quality measures finalized in the CY 2018 Quality
Payment Program final rule, and includes recommendations to add or
remove the current MIPS quality measures from the specialty measure
sets. All specialty measure set recommendations submitted for
consideration were assessed to ensure that they meet the needs of the
Quality Payment Program.
---------------------------------------------------------------------------

\19\ Listserv messaging was distributed through the Quality
Payment Program listserv on January 9th, 2018, titled: ``CMS is
Soliciting Stakeholder Recommendations for Potential Consideration
of New Specialty Measure Sets and/or Revisions to the Existing
Specialty Measure Sets for the 2019 Program Year of Merit-based
Incentive Payment System (MIPS).''
---------------------------------------------------------------------------

In the CY 2017 Quality Payment Program final rule (81 FR 77137), we
finalized that substantive changes to MIPS quality measures, to include
but are not limited to, measures that have had measure specification
changes, measure title changes, or domain changes. MIPS quality
measures with finalized substantive changes can be found in Table Group
D of the ``Appendix 1: Finalized MIPS Quality Measures'' of this final
rule.
As referenced in the CY 2017 Quality Payment Program final rule (81
FR 77291), with regards to eCQMs, in the 2015 EHR Incentive Program
final rule, CMS required eligible clinicians, eligible hospitals, and
critical access hospitals (CAHs) to use the most recent version of an
eCQM for electronic reporting beginning in 2017 (80 FR 62893). We
proposed this policy for the end-to-end electronic reporting bonus
under MIPS and encourage MIPS eligible clinicians to work with their
EHR vendors to ensure they have the most recent version of the eCQM. We
will not accept an older version of an eCQM as a submission for the
MIPS program for the quality performance category or the end-to-end
electronic reporting bonus within that category. MIPS eligible
clinicians and groups reporting on the quality performance category are
required to use the most recent version of the eCQM specifications. The
annual updates to the eCQM specifications and any applicable addenda
are available on the electronic quality improvement (eCQI) Resource
Center website at https://ecqi.healthit.gov for the applicable
performance period. Furthermore, as discussed in section III.E. of this
final rule, the Medicaid Promoting Interoperability Program generally
intends to utilize eCQM measures as they are available in MIPS. We
refer readers to section III.E. of this final rule for additional
details and criteria on the Medicaid Promoting Interoperability
Program.
In MIPS, there are a limited number of CMS Web Interface measures.
We solicited comment on building upon the CMS Web Interface submission
type by expanding the core set of measures available for that
submission type to include other specialty specific measures (such as
surgery). We thank stakeholders for their comments, and will consider
it for future rulemaking.
To provide clinicians with a more cohesive reporting experience,
where they may focus on activities and measures that are meaningful to
their scope of practice, we discuss the development of public health
priority measurement sets that would include measures and activities
across the quality, Promoting Interoperability, and improvement
activities performance categories, focused on public health priorities
such as fighting the opioid epidemic, in section III.I.3.h.(5), of this
final rule. We refer readers to section III.I.3.h.(5) of this final
rule for additional details on this concept.
We received comments on the proposal to revise the definition of a
high priority measure, to include quality measures that relate to
opioids and to further clarify the types of outcome measures that are
considered high priority; and the policy that MIPS eligible clinicians
must use the most recent specification of MIPS eCQMs while reporting
for MIPS:
Comment: A few commenters expressed concern with the proposals to
revise the definition of high-priority measures to include opioid
related quality measures and to add several new measures to the MIPS
program specifically focused on opioid use. The commenters urged CMS to
consider the unintended consequences that could result if seriously ill
patients experience barriers to receiving appropriate pain management.
Specifically, commenters stated that, if the proposed policies are
finalized, they could create incentives to reduce opioid prescriptions,
even for patients with debilitating pain resulting from advanced
disease progression who would respond to opioid treatment with more
potential benefit than risk. The commenters also asked CMS to consider
protections that could be incorporated into opioid-focused measures,
such as exceptions for patients receiving hospice and palliative care
and other patients with advanced stage serious illness. Further,
commenters suggested that CMS rely on clinical evidence regarding the
reliability and validity of measures or activities to address public
health and safety concerns with opioids. One commenter also expressed
concerns that measures may not take into account numerous factors that
play a role in the opioid crisis, including habits outside of
clinicians' control such as combining opioids with other medicines,
using opioid for something other than pain, and failure to adhere to
medicines as prescribed. One commenter

[[Page 59760]]

recommended including quality measures that address the application of
non-addictive alternatives to pain management, whether in the form of
pharmacotherapeutics, medication-assisted treatment, or non-
pharmacological options.
Response: To clarify, our intention is not to create barriers for
seriously ill patients receiving appropriate pain management, we
encourage appropriate treatment, but also encourage proper monitoring,
management, follow-up, and education of patients. We believe it is
important to consider patients such as those receiving hospice and
palliative care, and will discuss with measure stewards of opioid-
related measures whether exceptions for such patients may be
appropriate. Furthermore, we have considered the reliability and
validity of measures, as we require that measures have completed
reliability and validity testing prior to them being considered as
quality measures in MIPS. We agree with commenters that the application
of non-addictive alternatives to pain management is an important area
to include in quality measurement, and encourage stakeholders to reach
out to the measure stewards for the consideration of their suggestions.
Based on the comments and concerns expressed by commenters, we are
clarifying that the finalized definition of a high priority measure is
broad enough to include all aspects of opioid-related measurement
rather than focus on a specific aspect of opioid measurement. We
believe there are multiple areas within opioid measurement that are
important; for example (but not limited to): Medication management,
patient education, patient outcomes, monitoring, pain management, and
follow-up.
Comment: Several commenters agreed that opioid-related measures
should be categorized as high-priority measures due to national
interest. The commenters encouraged CMS to evaluate the inclusion of
any opioid-related measures, especially eCQMs that measure developers
bring to the table. Commenters stated that any opioid-related quality
measures, especially if designated as high-priority measures, need to
recognize that numerous factors play a role in opioid use, including
factors such as pain control, patient use of other medicines combined
with opioids, patient use of opioids for something other than pain, and
patient failure to adhere to medicines as prescribed. One commenter
cautioned against focusing solely on overuse, but rather focus on a
combination of how well patient's pain is controlled, if functional
improvement goals have been met, and opioid use. A few commenters
indicated that identifying patients by daily use and daily dosage may
not, on its own, be a good indication of quality patient care.
Commenters also encouraged CMS to include patient-reported outcomes
measures that look at symptom management and pain interference.
Response: We will consider opioid-related quality measures as they
are submitted through the call for measures process or as QCDR
measures, and also encourage the development of fully tested eCQMs. We
agree with the commenters that factors such as pain control, use of
other medications, and adherence are all important factors and that
overuse should not be the only focus of measurement. We encourage
stakeholders to submit patient-reported outcomes measures that also
relate to opioids during the call for measures process or as QCDR
measures during the self-nomination process.
Comment: A few commenters expressed support of the policy to
require the reporting of the most current version of the eCQM. One
commenter recommended that to improve electronic capture, calculation,
and reporting of quality measures, CMS should incent the use of
standardized semantic content from recognized developers. Further, the
commenter encouraged CMS to incorporate this work into its
implementation guides to ensure eCQM calculations and benchmarks are
accurate and that EHRs are accurately capturing eCQMs. In addition, a
commenter noted that to continue to encourage eCQM reporting, CMS
should not remove the 8 eCQMs from the measure list in 2019 as
proposed.
Response: We will take these recommendations into consideration for
future years of MIPS. We note that eCQM calculation standards are also
included as a part of ONC's Health IT Certification Program to ensure
accuracy and consistency. We refer readers to the 2015 Edition Health
IT Certification Criterion at 45 CFR 170.315(c)(1) (Clinical quality
measures) for additional information on the criteria. Furthermore, we
have identified those 8 eCQMs for removal for reasons including the
measure having high, unvarying performance rates, or the measure is
being replaced by a more robust measure that has a more meaningful
quality action. Quality actions include steps taken to advance the
patient care provided, moving beyond documenting in the medical record
or conducting a standard of care process. For example, was a follow-up
examination conducted on the patient monitor changes in medical
condition or did the specialist follow-up with the primary care
physician to close the referral loop. We believe that it is important
to have measures in the program that provide meaningful quality
measurement, by demonstrating a performance gap and having a robust
quality action.
Comment: A few commenters did not support the timeline for removing
eCQMs from the measure set because of the time required for EHR vendors
to modify systems. One commenter recommended supporting the last two
versions of eCQMs to allow sufficient time for vendors and health care
organizations to develop and deploy the latest eCQM versions.
Response: As described in the CY 2017 Quality Payment Program final
rule (81 FR 77291), in the 2015 EHR Incentive Programs final rule, CMS
required EPs, eligible hospitals, and CAHs to use the most recent
version of an eCQM for electronic reporting beginning in 2017 (80 FR
62893). Furthermore, we update specifications annually in order to stay
relevant with the clinical guidelines, updates to terminology, and to
correct any identified issues. We will take this recommendation into
further consideration, as we plan for our annual update process
improvements.
Comment: A few commenters requested clarification on whether or not
practices will be required to use 2015 Edition CEHRT for the entire
performance year for quality and the latest version of eCQM to earn the
end-to-end bonus.
Response: As described at Sec. 414.1305, the definition of CEHRT
for 2019 and subsequent years is EHR technology (which could include
multiple technologies) certified under the ONC Health IT Certification
Program that meets the 2015 Edition Base EHR definition (as defined at
45 CFR 170.102), and has been certified to the 2015 Edition health IT
certification criteria. In the CY 2017 Quality Payment Program final
rule (81 FR 77297), we finalized that the CEHRT bonus would be
available to MIPS eligible clinicians who report via qualified
registries, QCDRs, EHRs, or the CMS Web Interface for the Quality
Payment Program, in a manner that meets the end-to-end reporting
requirements. Thus, in order for practices to earn the end-to-end bonus
for reporting eCQMs for the 2019 performance period, they will need to
be reporting using the latest version of the eCQM and will need to use
CEHRT that has been certified to the 2015 Edition.

[[Page 59761]]

Comment: A few commenters noted concern with the timeline for the
approval and communication of updated quality measures with the 12-
month performance period, noting that clinicians and groups relying on
this information for measure selection are unable to easily access a
measure list until months after the performance period begins.
Commenters also noted that QCDR measures have traditionally not been
approved until the end of December preceding the performance year,
leaving registries with limited time to update their dashboards in time
for the January 1 start of the new performance year. Commenters stated
that clinicians need additional time to work with their EHRs to ensure
that they are capturing the elements necessary to report on a measure.
Therefore, commenters urged CMS to approve and communicate updates
earlier.
Response: With regard to MIPS quality measures, the final
specifications of the measures can only be posted once the final rule
is published. For Year 2 of the program there was a delay in posting
the measures within the Quality Payment Program Explore Measures Tool
due to technical difficulties. However, the measure specifications were
made available on the Quality Payment Program resource library (https://
qpp.cms.gov) prior to the beginning of the performance period. We will
continue to post the year 3 measure specifications on the Quality
Payment Program resource library prior to the beginning of the
performance period and will make every effort to update the Quality
Payment Program Explore Measures Tool with the year 3 measures prior to
the performance period, or as close to the beginning of the performance
period as technically feasible. We also note that we do not incorporate
the QCDR measures into the Quality Payment Program Explore Measures
Tool, rather these will be available on the Quality Payment Program
resource library. During the limited timeframe available between
November 1st and January 1st, we have reviewed over a thousand QCDR
measure submissions for consideration in the upcoming MIPS performance
period, communicated those decisions to the QCDRs, and posted the
qualified postings by January 1 of the performance period. QCDRs and
registries are notified prior to January 1 regarding which measures
will be approved for the upcoming performance period. In section
III.I.3.k.(3) of this final rule, we describe the finalized policy to
move the self-nomination period up to begin in July 1 and end on
September 1, thereby giving us an earlier start to evaluate and make
decisions on QCDR measures.
Comment: Many commenters stated that the current timeline for
release of measure specifications in December is overly burdensome and
hinders the consistency of measure data in terms of comparability of
results over time as it does not allow adequate time to build and test
systems prior to QCDRs reporting measures on January 1.
Response: We understand the commenters' concerns, and interpret
their reference to measures to mean the MIPS quality measure
specifications not the QCDR measure specifications. We clarify that it
is not technically feasible to release the MIPS quality measure
specifications until the final rule is published. We will take the
commenters suggestion in to consideration as we consider the
operational feasibility of releasing the MIPS quality measure
specifications earlier than December. As stated in the CY 2017 Quality
Payment Program final rule (81 FR 77368), in order for a QCDR to be
approved for a given performance period, they must support the minimum
of 6 quality measures to be approved. Similar to previous performance
periods, we plan to provide QCDRs and qualified registries with time to
select additional MIPS quality measures to support for the upcoming
performance period based upon their review of the measure
specifications. Furthermore, we note that we expect that QCDRs and
qualified registries would be up and running by January 1 of the
performance period to accept and retain data, to allow clinicians to
begin their data collection on January 1 of the performance period.
However, the data will not be submitted to us until the start of data
submission for the 2019 performance period.
After consideration of the public comments received, we are
finalizing our proposal, beginning with the 2021 MIPS payment year, to
define a high priority measure at Sec. 414.1305 as an outcome,
appropriate use, patient safety, efficiency, patient experience, care
coordination, or opioid-related quality measure. Outcome measures
include intermediate-outcome and patient-reported outcome measures.
In the CY 2017 Quality Payment Program final rule (81 FR 77090), we
indicated that we intend to reduce the number of claims-based measures
in future program years as more measures become available through
electronic collection types such as eCQMs or MIPS CQMs. In section
III.I.3.h of this final rule, we are finalizing our proposal to limit
the Medicare Part B claims collection type to small practices, which
furthers our goal of moving away from Medicare Part B claims measures.
We strongly encourage measure stewards to keep this in mind as they
develop and submit measures for consideration, during the call for
measures process (specifically for the MIPS quality performance
category).
(ii) Topped Out Measures
In the CY 2018 Quality Payment Program final rule (82 FR 53637
through 53640), we finalized the 4-year timeline to identify topped out
measures, after which we may propose to remove the measures through
future rulemaking. After a measure has been identified as topped out
for 3 consecutive years through the benchmarks, we may propose to
remove the measure through notice and comment rulemaking. Therefore, in
the 4th year, if finalized through rulemaking, the measure would be
removed and would no longer be available for reporting during the
performance period. We refer readers to the 2018 MIPS Quality
Benchmarks' file, that is located on the Quality Payment Program
resource library (https://www.cms.gov/Medicare/Quality-Payment-Program/Resource-Library/Resource-library.html) to determine which measure
benchmarks are topped out for 2018 and would be subject to the cap if
they are also topped out in the 2019 MIPS Quality Benchmarks' file. It
should be noted that the final determination of which measure
benchmarks are subject to the topped out cap would not be available
until the 2019 MIPS Quality Benchmarks' file is released in late 2018.
In the CY 2019 PFS proposed rule (83 FR 35899 through 35900), we
proposed that once a measure has reached an extremely topped out status
(for example, a measure with an average mean performance within the
98th to 100th percentile range), we may propose the measure for removal
in the next rulemaking cycle, regardless of whether or not it is in the
midst of the topped out measure lifecycle, due to the extremely high
and unvarying performance where meaningful distinctions and improvement
in performance can no longer be made, after taking into account any
other relevant factors. We are concerned that topped out non-high
priority process measures require data collection burden without added
value for eligible clinicians and groups participating in MIPS. It is
important to remove these types of measures, so that available measures
provide meaningful value to

[[Page 59762]]

clinicians collecting data, beneficiaries, and the program. However, we
would also consider retaining the measure if there are compelling
reasons as to why it should not be removed (for example, if the removal
would impact the number of measures available to a specialist type or
if the measure addressed an area of importance to the Agency).
Since QCDR measures are not approved or removed from MIPS through
the rulemaking timeline or cycle, we proposed to exclude QCDR measures
from the topped out timeline that was finalized in the CY 2018 Quality
Payment Program final rule (82 FR 53640). When a QCDR measure reaches
topped out status, as determined during the QCDR measure approval
process, it may not be approved as a QCDR measure for the applicable
performance period. Because QCDRs have more flexibility to develop
innovative measures, we believe there is limited value in maintaining
topped out QCDR measures in MIPS.
We received comments on the following proposals: (1) Once a measure
has reached an extremely topped out status (for example, a measure with
an average mean performance within the 98th to 100th percentile range),
we may propose the measure for removal in the next rulemaking cycle,
regardless of whether or not it is in the midst of the topped out
measure lifecycle; and (2) to exclude QCDR measures from the topped out
timeline that was finalized in the CY 2018 Quality Payment Program
final rule:
Comment: Several commenters supported the topped out proposal,
stating that it would reduce clinician burden, discontinue measures
that have limited value to the Quality Payment Program, and continue to
focus on measures that are clinically meaningful to patients. One
commenter noted that this proposal will allow CMS to differentiate
between exceptional, high performing, and other clinicians. Several
commenters recommended that topped out measures be removed regardless
of the collection type.
Response: We disagree that topped out measures should be removed
regardless of the collection type. There have been instances where
measures have been specified through multiple collection types, but
have only become topped out in one or two of the collection types. If
there is an opportunity to collect more robust data on a measure, while
the measure is not topped out for that particular collection type, we
believe we should continue to do so.
Comment: Several commenters did not support the proposal to exclude
QCDR measures from the topped out timeline, indicating that review
processes for QCDR and MIPS measures should be standardized and provide
clinicians, groups, and measure stewards sufficient notice to review
and potentially replace topped out measures. One commenter indicated
that applying the topped out policy to QCDR measures will also ensure
consistency across the program and minimize complexity. A few
commenters indicated that maintaining QCDR measures in the program for
a minimum number of years will also limit measures with sufficient
historical data to set a benchmark that permits the evaluation of
performance. Several commenters noted that removal of topped out QCDR
measures would limit the number of specialty-specific measures
available and stated that and the proposal does not allow sufficient
time and volume of cases to determine if QCDR measures have a valid
benchmark. One commenter recommended a two-year retention policy for
extremely topped out QCDR measures to reduce burden and confusion for
clinicians.
Response: We note that the process and timeline in which MIPS
quality measures and QCDR measures are approved for a given MIPS
performance period is different, as is the criteria for consideration.
QCDRs are expected to be nimble and innovative enough to develop QCDR
measures that are robust in their quality action and demonstrate a
performance gap. We believe topped out measures do not add value in the
realm of quality measurement, and believe they should be removed from
the program as appropriate. We do not agree that removing topped out
QCDR measures would create complexity, since it is a well-established
process that QCDR measures are reviewed for approval on an annual
basis, and is something that stakeholders should be aware of. We also
do not believe that topped out QCDR measures should be retained in the
program for 2 years; this may inadvertently impact a high performing
clinician who may not receive a high score when compared to other
clinicians reporting on the same measure. For example, a clinician
whose performance rate is at 96 percent on a topped out measure may
receive fewer points than another clinician whose reporting rate is at
98 percent on the same measure, when both performance rates would be
considered high performing. We do not agree that the removal of topped
out QCDR measures would impact the number of available specialty-
specific measures available, since QCDR measures are reviewed and
approved on a more accelerated timeline in comparison to the MIPS
quality measures. Furthermore, MIPS eligible clinicians who wish to use
QCDRs, are not limited to reporting on QCDR measures.
Comment: Many commenters did not support the proposal to allow the
identification and removal of extremely topped out measures. Several
commenters noted that removal of measures will have a large impact on
small practices and specialists who have limited options regarding
relevant quality measures. Several commenters stated that more time is
needed to determine if measures are truly topped out because benchmarks
may reflect the performance of only top-performing clinicians rather
than performance across all clinicians. They stated that additional
time would allow for the collection of more robust data. Many
commenters stated that topped out measures should all have the same 4-
year timeline because the process to develop a measure that could
replace a topped out measure is lengthy and recommended close
communication with measure stewards. A few commenters recommended a 2-
year timeline for the removal of extremely topped out measures. A few
commenters encouraged CMS to defer to measure developers and national
endorsement organizations to define which measures are topped out. One
commenter noted that additional factors should be taken into
consideration prior to removing an extremely topped out measure,
including the type of measure, the length of time the measure is
reported, measure steward and specialist input, performance results,
reporting options, data sources, small sample size, public health
issues covered, and whether measures are used in other programs. One
commenter recommended that prior to removing a topped out measure, CMS
be transparent about the data used to determine topped out status, so
the public has an understanding of how many clinicians reported the
measure and the performance rate.
Response: We note that in addition to the quality measures
available in the MIPS quality measure set, QCDR measures are also
available. We review measure benchmarks as a part of our process for
identifying topped out and extremely topped out measures and believe
that extremely topped out measures, such as those with an average mean
performance within the 98th to 100th percentile, leave no room for
further quality improvement, thereby providing clinicians little value.
We

[[Page 59763]]

utilized the 2018 quality measure benchmarks as a part of the criteria
used to identify those measures for removal. The benchmarks are
reflective of the performance of those clinicians who have reported on
the measure and will continue to do so should the measure be available
in the program which is why we do not believe there will be variances
in the high performing data submitted if the measure is retained. We do
not believe that we should retain the extremely topped out measures
within a 4 year timeline because the measures take a lengthy time to
replace. While the timeline to add MIPS quality measures does typically
take about 2 years, we note there are additional measures (QCDR
measures) available for reporting through QCDRs. We appreciate the
commenters' feedback suggesting we defer to measure developers and
national endorsement organizations to define which measures are topped
out; we can take this suggestion in to future consideration. In the CY
2019 PFS proposed rule (83 FR 35900), we stated we would also consider
retaining the measure if there are compelling reasons as to why it
should not be removed (for example, if the removal would impact the
number of measures available to a specialist type or if the measure
addressed an area of importance to the Agency). We encourage
stakeholders to continue to submit quality measures that address
measurement gaps as we incrementally remove quality measures that are
extremely topped out, merely reflect the standard of care without a
quality action, or are duplicative of other more robust quality
measures, as we believe they no longer provide meaningful measurement
to clinicians.
After consideration of the public comments received, we are
finalizing our proposal that once the measure has reached an extremely
topped out status (for example, a measure with an average mean
performance within the 98th to 100th percentile range), we may propose
the measure for removal in the next rulemaking cycle, regardless of
whether or not it is in the midst of the topped out measure lifecycle,
due to the extremely high and unvarying performance where meaningful
distinctions and improvement in performance can no longer be made,
after taking into account any other relevant factors. However, we will
also consider retaining the measure if there are compelling reasons as
to why it should not be removed (for example, if the removal would
impact the number of measures available to a specialist type or if the
measure addressed an area of importance to CMS).
We are also finalizing our proposal to exclude QCDR measures from
the topped out timeline that was finalized in the CY 2018 Quality
Payment Program final rule (82 FR 53640). When a QCDR measure reaches
topped out status, as determined during the QCDR measure approval
process, it may not be approved as a QCDR measure for the applicable
performance period.
(iii) Removal of Quality Measures
In the CY 2017 Quality Payment Program final rule (81 FR 77136
through 77137), we discussed removal criteria for quality measures,
including that a quality measure may be considered for removal if the
Secretary determines that the measure is no longer meaningful, such as
measures that are topped out. Furthermore, if a measure steward is no
longer able to maintain the quality measure, it would also be
considered for removal.
We have previously communicated to stakeholders our desire to
reduce the number of process measures within the MIPS quality measure
set. In the CY 2017 Quality Payment Program final rule (81 FR 77101),
we explained that we believe that outcome measures are more valuable
than clinical process measures and are instrumental to improving the
quality of care patients receive. In the CY 2018 Quality Payment
Program quality measure set, 102 of the 275 quality measures are
process measures that are not considered high priority. As discussed
above, beginning with the 2021 MIPS payment year, we proposed to define
at Sec. 414.1305 a high priority measure to mean an outcome,
appropriate use, patient safety, efficiency, patient experience, care
coordination, or opioid-related quality measure. Because the removal of
all non-high priority process measures would impact most specialty
sets, nearly 94 percent, we believe incrementally removing non-high
priority process measures through notice and comment rulemaking is
appropriate.
As described in the CY 2019 PFS proposed rule (83 FR 35900),
beginning with the 2019 performance period, we proposed to implement an
approach to incrementally remove process measures where prior to
removal, consideration will be given to, but is not limited to:
Whether the removal of the process measure impacts the
number of measures available for a specific specialty.
Whether the measure addresses a priority area highlighted
in the Measure Development Plan at https://www.cms.gov/Medicare/
Quality-Payment-Program/Measure-Development/Measure-development.html.
Whether the measure promotes positive outcomes in
patients.
Considerations and evaluation of the measure's performance
data.
Whether the measure is designated as high priority or not.
Whether the measure has reached an extremely topped out
status within the 98th to 100th percentile range, due to the extremely
high and unvarying performance where meaningful distinctions and
improvement in performance can no longer be made, as described in
section III.I.3.(b)(ii) of this final rule.
We received the following comments on the proposal to implement a
process to incrementally remove process measures:
Comment: While some commenters supported the inclusion of
population measures, several commenters recommended the removal of
population health measures, which it believed are often incorrectly
attributed, especially for specialty clinicians and rural clinicians,
and often have a very low statistical reliability at the individual
clinician and group practice levels.
Response: We believe that population measures may reduce burden on
clinicians and allow for assessment of public health issues on a larger
scale. Reliability is one of the many important and scientific issues
that CMS addresses and tests during our measure development process
regardless of measure type (that is, whether the measures are
population-based or provider-specific measures). We recognize that
specialty clinicians and rural clinicians may be more likely to have a
smaller sample size, and that this may result in lower reliability. At
the same time, we also recognize that many clinicians or groups may
have sufficient volume depending on the measures under development, and
because measure reliability also depends on the particular cohort and
outcome of the specific measures under development. As part of the CMS
standardized measure development process, we will address the
reliability issue in several ways. We will consult national experts and
stakeholders including health care providers and patients in
conceptualizing and selecting measures for development and conduct
rigorous testing of the measure reliability and volume threshold for
use.
Comment: Many commenters supported the removal of 34 MIPS measures
to align with CMS's Meaningful Measures framework and allow eligible
clinicians to reduce and

[[Page 59764]]

prioritize other measures, providing a focus on improving patient care
and outcomes. A few commenters encouraged CMS to continue to review its
quality measure sets to identify the most meaningful measures and
further align hospital and clinician reporting requirements.
Response: We agree that alignment across quality programs is
important in an effort to reduce clinician burden, and will seek to
continue to look for ways to align with other programs while
maintaining the objective and goals of MIPS through future rulemaking.
Comment: Many commenters did not support the proposal to remove
measures, stating that many specialists will not have enough relevant
measures to meet reporting requirements, clinicians may still be
required to report removed measures to other payers, and process
measures are under the control of the clinician and often important
when coupled with other measures including cost measures. A few
commenters indicated that important quality of care aspects may only be
captured by a process measure, even those that are topped out. One
commenter disagreed with the removal of topped out measures generally
until the vast majority of peer reviewed literature demonstrates a
significant change in practice patterns. One commenter recommended
delaying the removal of measures, to allow time for clinicians to
comply with program requirements.
Response: We note that prior to proposing to remove quality
measures from the program, we take into consideration the impacts the
removal would have on the number of measures available to clinicians in
the program. We do not agree that we should delay the removal of
measures. We continue to believe that non-high priority process
measures impose data collection burden without adding value for
eligible clinicians and groups participating in MIPS. Typically,
process measures merely reflect the standard of care and do not have a
robust quality action. In many instances, process measures have high,
unvarying performance leaving no room for improvement. We understand
that there are some process measures that are valuable, but believe
that it is important that they address one of the high priority areas
and demonstrate a performance gap in order to be meaningful.
Furthermore, we do understand that important quality of care aspects
may only be captured by some topped out process measures, and encourage
clinicians to continue to measure and monitor their progress in these
areas; however, we do not believe that these measures provide value or
should be tied to a pay for performance program such as MIPS. If a MIPS
quality measure is removed from the program, it is because the measure
no longer has value in the performance payment program; however, we
believe that clinicians can still collect and evaluate data on these
metrics for their own internal quality improvement goals or areas of
improvement as outlined in peer reviewed literature. We are aware that
there are certain process measures that may be required to be reported
to other payers; however, note that this difference may reflect
different underlying goals of their program. Another consideration is
that these process measures with high, unvarying performance, may also
impact a MIPS eligible clinician's ability to receive a high score in
the quality performance category. While we agree that process measures
are under the control of the clinician and often important when coupled
with other measures including cost measures, we do not believe that
this justifies retaining extremely topped out measures in MIPS.
Comment: Several commenters expressed concern about the timeline
for removing measures. A few commenters requested that CMS maintain the
4-year measure removal policy since it would give clinicians,
professional societies, and third party vendors (for example,
registries) some time to prepare and develop an alternative reporting
strategy. One commenter recommended an incremental phased approach
according to a specified timeline, similar to the 4-year timeline
currently in place for removing topped out measures from the program in
order to ensure that the removal of the measures is truly warranted and
to allow clinicians time to begin implementing other measures for
reporting purposes. One commenter recommend that CMS only propose
removal of measures during the official measure process to assist with
predictability.
Response: To clarify, similar to how MIPS quality measures are
proposed and finalized into the MIPS program through notice-and-comment
rulemaking, we utilize a similar approach for removing measures from
the program. We do not believe that a 4-year timeline to remove all
measures is appropriate. A topped out measure timeline that is 4 years
long is appropriate for measures with high performance where special
scoring caps are applied as a response to the high unvarying
performance; however, we are still finalizing the policy to remove
extremely topped out measures (within the 98-100 percent range) through
the following rulemaking cycle after the measure is identified as
extremely topped out. This is to note that there are exceptions to the
4 year timeline, and in instances where there are more robust measures
being proposed and finalized, we believe it is appropriate to remove
duplicative measures through notice-and-comment rulemaking without
consideration to a longer timeline. In addition, measures that are not
maintained or updated to reflect current clinical guidelines are not
reflective of a clinician's scope of practice, should also be proposed
for removal in the next rulemaking cycle. Furthermore, the removal of
low-bar, standard of care process measures aligns with our goals to
have more outcomes based measures in the program. Furthermore, a 4-year
timeline does not take into consideration that we may propose new
quality measures that are more robust in their quality action that
would deem the existing process measure to be duplicative. Also, as
process measures top out, they will inadvertently impact a clinician's
ability to achieve a high score for that specific measure. As stated
earlier above, we will only propose the removal of MIPS quality
measures through formal notice-and-comment rulemaking, and we believe
that this annual process will provide stakeholders with sufficient
notice and opportunity to voice their concerns on specific measure
removals through the public comment process.
Comment: One commenter also requested that CMS evaluate measures
for removal based on the collection type. They stated that the
differences in collection types can be enough of a workflow and cost
consideration in alterations that it should be a factor in the
consideration of measures removal. For example, there are several eCQMs
proposed for removal due to a duplicative measure being available;
however, in most instances, that duplicative measure is not available
as an eCQM. This would potentially force practices to maintain
relationships and pay for reporting through multiple vendors to
maintain their list of measures.
Response: Initially, we proposed to remove specific MIPS quality
measures that were duplicative of new, robust measures. We have taken
the comments into consideration and in instances where the new measure
does not have eCQM available as a collection type, we have decided not
to remove the existing (duplicative) measure for the eCQM collection
type only. We refer readers to Appendix 1: Finalized Quality Measures
of this final rule for additional detail on

[[Page 59765]]

these eCQMs. We clarify that we do look at the availability of measures
through the different collection types as we review measures for
possible inclusion or removal, and will continue to monitor and
consider the availability through the collection types as criteria when
removing quality measures from MIPS.
After consideration of the public comments received, we are
finalizing our proposal, beginning with the 2021 MIPS payment year, to
implement an approach to incrementally remove process measures where
prior to removal, consideration will be given to, but will not be
limited to:
Whether the removal of the process measure impacts the
number of measures available for a specific specialty.
Whether the measure addresses a priority area highlighted
in the Measure Development Plan: https://www.cms.gov/Medicare/Quality-
Payment-Program/Measure-Development/Measure-development.html.
Whether the measure promotes positive outcomes in
patients.
Considerations and evaluation of the measure's performance
data.
Whether the measure is designated as high priority or not.
Whether the measure has reached an extremely topped out
status within the 98th to 100th percentile range, due to the extremely
high and unvarying performance where meaningful distinctions and
improvement in performance can no longer be made.
(iv) Categorizing Measures by Value
In the CY 2019 PFS proposed rule (83 FR 35900), we outlined the
various types of MIPS quality and QCDR measures available for reporting
in the quality performance category, such as outcome, high-priority,
composite, and process measures, we acknowledge that not all measures
are created equal. For example, the value or information gained by
reporting on certain process measures does not equate that which is
collected on outcome measures. We seek to ensure that the collection
and submission of data is valuable to clinicians and worth the cost and
burden of collecting the information.
Based on this, we solicited comment on implementing a system where
measures are classified as a particular value (gold, silver or bronze)
and points are awarded based on the value of the measure. For example,
higher value measures that are considered ``gold'' standard, which
could include outcome measures, composite measures, or measures that
address agency priorities (such as opioids). The CAHPS for MIPS survey,
which collects patient experience data, may also be considered a high
value measure. Measures that are considered second tier, or at a
``silver'' standard would be measures that are considered process
measures that are directly related to outcomes and have a good gap in
performance (there is no high, unwavering performance) and demonstrate
room for improvement; or topped out outcome measures. Lower value
measures, such as standard of care process measures or topped out
process measures would be considered ``bronze'' measures. We refer
readers to section III.I.3.i.(1)(b)(xi) of this final rule for
discussion on the assignment of value and scoring based on measure
value.
We have received comments from stakeholders regarding categorizing
measure by value. We thank commenters for their input and may take this
input into consideration in future years.
(3) Cost Performance Category
For a description of the statutory basis and our existing policies
for the cost performance category, we refer readers to the CY 2017 and
CY 2018 Quality Payment Program final rules (81 FR 77162 through 77177,
and 82 FR 53641 through 53648, respectively).
(a) Weight in the Final Score
In the CY 2018 Quality Payment Program final rule, we established
that the weight of the cost performance category would be 10 percent of
the final score for the 2020 MIPS payment year (82 FR 53643). We had
previously finalized in the CY 2017 Quality Payment Program final rule
at Sec. 414.1350(b)(3) that beginning with the 2021 MIPS payment year,
the cost performance category would be 30 percent of the final score,
as required by section 1848(q)(5)(E)(i)(II)(aa) of the Act (81 FR
77166). Section 51003(a)(1)(C) of the Bipartisan Budget Act of 2018,
enacted on February 9, 2018, amended section 1848(q)(5)(E)(i)(II)(bb)
of the Act such that for each of the second, third, fourth, and fifth
years for which the MIPS applies to payments, not less than 10 percent
and not more than 30 percent of the MIPS final score shall be based on
the cost performance category score. Additionally, this provision shall
not be construed as preventing the Secretary from adopting a 30 percent
weight if the Secretary determines, based on information posted under
section 1848(r)(2)(I) of the Act, that sufficient cost measures are
ready for adoption for use under the cost performance category for the
relevant performance period. Section 51003(a)(2) of the Bipartisan
Budget Act of 2018 amended section 1848(r)(2) of the Act to add a new
paragraph (I), which we discuss in section III.I.3.h.(3)(b)(i) of this
final rule.
In light of these amendments, in the proposed rule (83 FR 35900
through 35901), we proposed at Sec. 414.1350(d)(3) that the cost
performance category would make up 15 percent of a MIPS eligible
clinician's final score for the 2021 MIPS payment year. As discussed in
section III.I.3.h.(3)(b)(iv) of this final rule, Sec. 414.1350(b) will
be redesignated as Sec. 414.1350(d). We proposed to delete the
existing text under Sec. 414.1350(b)(3) and address the weight of the
cost performance category for the MIPS payment years following 2021 in
future rulemaking. We also proposed a technical change to the text at
Sec. 414.1350(b) (redesignated as Sec. 414.1350(d)) to state that the
cost performance category weight will be as specified under
redesignated Sec. 414.1350(d), unless a different scoring weight is
assigned by CMS under section 1848(q)(5)(F) of the Act (83 FR 35901).
We believe that measuring cost is an integral part of measuring
value, and we believe that clinicians have a significant impact on the
costs of patient care. However, we proposed to only modestly increase
the weight of the cost performance category for the 2021 MIPS payment
year from the 2020 MIPS payment year because we recognize that cost
measures are still relatively early in the process of development and
that clinicians do not have the level of familiarity or understanding
of cost measures that they do of comparable quality measures (83 FR
35900 through 35901). As described in section III.I.3.h.(3)(b)(ii) of
this final rule, we are finalizing the addition of 8 episode-based
measures to the cost performance category beginning with the 2019 MIPS
performance period. This is a first step in developing a more robust
and clinician-focused measurement of cost performance. We will continue
to work on developing additional episode-based measures that we may
consider proposing for the cost performance category in future years.
Introducing more measures over time would allow for more clinicians to
be measured in this performance category. It would also allow time for
more outreach to clinicians to better educate them on the cost
measures. We considered maintaining the weight of the cost performance
category at 10 percent for the 2021 MIPS payment year as we recognize
that clinicians are still learning about the cost performance category
and being introduced to new measures. We invited comment on

[[Page 59766]]

whether we should consider an alternative weight for the 2021 MIPS
payment year.
The following is a summary of the public comments received on these
proposals and our responses:
Comment: Several commenters supported our proposal to increase the
weight of the cost performance category to 15 percent for the 2021 MIPS
payment year, noting the importance of managing cost in measuring the
value of a clinician as well as the opportunity to gradually increase
the weight of the performance category.
Response: We thank the commenters for their support for this
proposal.
Comment: Several commenters opposed our proposal to increase the
weight of the cost performance category to 15 percent for MIPS payment
year 2021. They believed that the increased flexibility provided by the
Bipartisan Budget Act of 2018 should be used to maintain the weight at
10 percent for MIPS payment year 2021 and in future years. Some
commenters requested that the weight of the cost performance category
not be increased until CMS can address issues of social and complexity
risk factors and of clinical risk adjustment for measures in areas such
as oncology. Some commenters suggested maintaining the weight of the
cost performance category at 10 percent until CMS is able to provide
more detailed and actionable performance data and develop more reliable
and valid measures.
Additionally, several commenters opposed our proposal to increase
the weight of the cost performance category because we proposed to add
new episode-based measures (as detailed in section III.I.3.h.(3)(b)(ii)
of this rule) and clinicians should have time to learn about these
measures before the category weight is increased. Additionally, several
commenters suggested CMS wait to increase the cost performance category
weight until sufficient episode groups exist for additional
specialties.
Response: We continue to investigate ways to best accommodate the
issue of clinical and social risk adjustment in measures contained in
the cost performance category. All measures included in the cost
performance category are adjusted for clinical risk. We have adopted a
complex patient bonus at the final score level that adjusts again for
patient clinical complexity as well as some elements of social
complexity. We also continue to consider ways to offer actionable
feedback on cost measures to clinicians in the future.
In regards to the episode-based measures, we do not believe the
introduction of these new measures should mean that the weight of the
performance category should be maintained, especially since
stakeholders had the opportunity to gain experience with the new
measures through field testing in the fall of 2017. The performance
category also still includes two measures that were used in the first 2
years of MIPS. The Bipartisan Budget Act of 2018 gave CMS increased
flexibility to establish the weight of the cost performance category
for the first 5 years of MIPS, but the weight is still required to be
30 percent beginning with the 2024 MIPS payment year. Therefore, we
believe it is necessary to begin adjusting the weight gradually,
including increasing the weight to 15 percent for the 2021 MIPS payment
year. We will concurrently look to increase the number of clinicians
who are measured in the cost performance category by developing and
considering for inclusion in the Quality Payment Program more episode-
based measures that cover additional types of clinicians and
specialties.
After consideration of the public comments, we are finalizing our
proposal at Sec. 414.1350(d)(3) to weight the cost performance
category at 15 percent for the 2021 MIPS payment year as proposed.
Additionally, we are also finalizing our proposal to delete the
existing text under Sec. 414.1350(b)(3) and address the weight of the
cost performance category for the MIPS payment years following 2021 in
future rulemaking as proposed. Finally, we are finalizing our proposed
technical change to the text at Sec. 414.1350(b) (redesignated as
Sec. 414.1350(d)) to state that the cost performance category weight
will be as specified under redesignated Sec. 414.1350(d), unless a
different scoring weight is assigned by CMS under section 1848(q)(5)(F)
of the Act, as proposed.
In accordance with section 1848(q)(5)(E)(i)(II)(bb) of the Act, we
will continue to evaluate whether sufficient cost measures are ready
for adoption under the cost performance category and move towards the
goal of increasing the weight to 30 percent of the final score. To
provide for a smooth transition, we anticipate that we would increase
the weight of the cost performance category by 5 percentage points each
year until we reach the required 30 percent weight for the 2024 MIPS
payment year. We invited comments on this approach to weighting the
cost performance category for the 2022 and 2023 MIPS payment years,
considering our flexibility in setting the weight between 10 percent
and 30 percent of the final score, the availability of cost measures,
and our desire to ensure a smooth transition to a 30 percent weight for
the cost performance category. We appreciate the comments we received
and will consider them as we develop proposals for future rulemaking.
(b) Cost Criteria
(i) Background
Under Sec. 414.1350(a), we specify cost measures for a performance
period to assess the performance of MIPS eligible clinicians on the
cost performance category. In the CY 2018 Quality Payment Program final
rule, we established two cost measures (total per capita cost measure
and Medicare spending per beneficiary (MSPB) measure) for the 2018 MIPS
performance period and future performance periods (82 FR 53644). These
measures were previously established for the 2017 MIPS performance
period (81 FR 77168). We will continue to evaluate cost measures that
are included in MIPS on a regular basis and anticipate that measures
could be added or removed through rulemaking as measure development
continues. In general, we expect to evaluate cost measures according to
the measure reevaluation and maintenance processes outlined in the
``Blueprint for the CMS Measures Management System'' (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/BlueprintVer14.pdf). As described in section
2 of the Blueprint for the CMS Measures Management System Version 14.0,
we will conduct annual evaluations to review the continued accuracy of
the measure specifications. Annual updates ensure that the procedure,
diagnostic, and other codes used in the measure account for updates to
coding systems over time. To the extent that these updates would
constitute a substantive change to a measure, we would ensure the
changes are proposed for adoption through rulemaking. We will also
comprehensively reevaluate the measures every 3 years to ensure that
they continue to meet measure priorities. As a part of this
comprehensive reevaluation, we will gather information through
environmental scans and literature reviews of recent studies and new
clinical guidelines that may inform potential refinements. We will also
analyze measure performance rates and re-assess the reliability and
validity of the measures. Throughout these

[[Page 59767]]

reevaluation efforts, we will summarize and consider all stakeholder
feedback received on the measure specifications during the
implementation process, and may seek input through public comment
periods. In addition, the measure development contractor may acquire
individual input on measures by convening Technical Expert Panels
(TEPs) and clinical subcommittees. Aside from these regular measure
reevaluations, there may be ad-hoc reviews of the measures if new
evidence comes to light which indicates that significant revisions may
be required.
We will also continue to update the specifications to address
changes in coding, risk adjustment, and other factors. The process for
updating measure specifications will take place through ongoing
maintenance and evaluation, during which we expect to continue seeking
stakeholder input. As we noted above, any substantive changes to a
measure would be proposed for adoption in future years through notice
and comment rulemaking. We appreciate the feedback that we have
received so far throughout the measure development process and believe
that stakeholders will continue to provide feedback to the measure
development contractor on episode-based cost measures by submitting
written comments during public comment opportunities, by participating
in the clinical subcommittees convened by the measure development
contractor, or by attending education and outreach events. We will take
all comments and feedback into consideration as part of the ongoing
measure evaluation process.
As we noted in the CY 2017 Quality Payment Program final rule (81
FR 77137) regarding quality measures, which we believe would also apply
for cost measures, some updates may incorporate changes that would not
substantively change the intent of the measure. Examples of such
changes may include updated diagnosis or procedure codes or changes to
exclusions to the patient population or definitions. While we address
such changes on a case-by-case basis, we generally believe these types
of maintenance changes are distinct from substantive changes to
measures that result in what are considered new or different measures.
As described in section 3 of the Blueprint for the CMS Measures
Management System Version 14.0, if substantive changes to these
measures become necessary, we expect to follow the pre-rulemaking
process for new measures, including resubmission to the Measures Under
Consideration (MUC) list and consideration by the Measure Applications
Partnership (MAP). The MAP provides an additional opportunity for an
interdisciplinary group of stakeholders to provide feedback on whether
they believe the measures under consideration are attributable and
applicable to clinicians. The MAP also reviews measures for clinician
level feasibility, reliability, and validity. They also consider
whether the measures are scientifically acceptable and reflect current
clinical guidelines.
Section 51003(a)(2) of the Bipartisan Budget Act of 2018 amended
section 1848(r)(2) of the Act to add a new paragraph (I) requiring the
Secretary to post on the CMS website information on cost measures in
use under MIPS, cost measures under development and the time-frame for
such development, potential future cost measure topics, a description
of stakeholder engagement, and the percent of expenditures under
Medicare Part A and Part B that are covered by cost measures. This
information shall be posted no later than December 31 of each year
beginning with 2018. We expect this posting will provide a list of the
cost measures established for the cost performance category for the
current performance period (for example, the posting in 2018 would
include a list of the measures for the 2018 MIPS performance period),
as well as a list of any cost measures that may be proposed for a
future performance period through rulemaking. We will provide
hyperlinks to the measure specifications documents and include the
percent of Medicare Part A and Part B expenditures that are covered by
these cost measures. The posting will also include a list and
description of the measures under development at that time. We intend
to summarize the timeline for measure development, including the
stakeholder engagement activities undertaken, which may include a TEP,
clinical subcommittees, field testing, and education and outreach
activities, such as national provider calls and listening sessions.
Finally, the posting will provide an overview of potential future
topics in cost measure development, such as any clinical areas in which
measures may be developed in the future (83 FR 35901 through 35902).
(ii) Episode-Based Measures for the 2019 and Future Performance Periods
Episode-based measures differ from the total per capita cost
measure and MSPB measure because episode-based measure specifications
only include items and services that are related to the episode of care
for a clinical condition or procedure (as defined by procedure and
diagnosis codes), as opposed to including all services that are
provided to a patient over a given timeframe.
We discussed our progress in the development of episode-based
measures in the CY 2018 Quality Payment Program proposed rule (82 FR
30049 through 30050) and received significant positive feedback on the
process used to develop the measures as well as the measures' clinical
focus that was informed by expert opinion (82 FR 53644 through 53646).
The specific measures selected for the initial round of field testing
were included based on the volume of beneficiaries impacted by the
condition or procedure, the share of cost to Medicare impacted by the
condition or procedure, the number of clinicians/clinician groups
attributed, and the potential for alignment with existing quality
measures.
We have developed episode-based measures to represent the cost to
Medicare for the items and services furnished to a patient during an
episode of care (``episode''). Episode-based measures are developed to
let attributed clinicians know the cost of the care clinically related
to their initial treatment of a patient and provided during the
episode's timeframe. Specifically, we define cost based on the allowed
amounts on Medicare claims, which include both Medicare payments and
beneficiary deductible and coinsurance amounts. Episode-based measures
are calculated using Medicare Parts A and B fee-for-service claims data
and are based on episode groups. Episode groups:
Represent a clinically cohesive set of medical services
rendered to treat a given medical condition.
Aggregate all items and services provided for a defined
patient cohort to assess the total cost of care.
Are defined around treatment for a condition (acute or
chronic) or performance of a procedure.
Items and services in the episode group could be treatment
services, diagnostic services, and ancillary items and services
directly related to treatment (such as anesthesia for a surgical
procedure). They could also be items and services that occur after the
initial treatment period that may be furnished to patients as follow-up
care or to treat complications resulting from the treatment. An episode
is a specific instance of an episode group for a specific patient and
clinician. For example, in a given year, a clinician might be
attributed 20 episodes (instances of the episode group) from the
episode group for heart failure. In section III.I.3.h.(3)(b)(iv) of
this final rule, we discuss the attribution rules for cost measures.

[[Page 59768]]

After episodes are attributed to one or more clinicians, items and
services may be included in the episode costs if they are furnished
within a patient's episode window. Items and services will be included
if they are the trigger event for the episode or if a service
assignment rule identifies them as a clinically related item or service
during the episode. The detailed specifications for these measures,
which include information about the service assignment rules, can be
reviewed at qpp.cms.gov.
To ensure a more accurate comparison of cost across clinicians,
episode costs are payment standardized and risk adjusted. Payment
standardization adjusts the allowed amount for an item or service to
facilitate cost comparisons and limit observed differences in costs to
those that may result from health care delivery choices. Payment
standardized costs remove any Medicare payment differences due to
adjustments for geographic differences in wage levels or policy-driven
payment adjustments such as those for teaching hospitals. Risk
adjustment accounts for patient characteristics that can influence
spending and are outside of clinician control. For example, for the
elective outpatient PCI episode-based measure, the risk adjustment
model may account for a patient's history of heart failure.
The measure development contractor has continued to seek extensive
stakeholder feedback on the development of episode-based measures,
building on the processes outlined in the CY 2018 Quality Payment
Program final rule (82 FR 53644). These processes included convening a
TEP and clinical subcommittees to solicit expert and clinical input for
measure development, conducting national field testing on the episode-
based cost measures developed, and seeking input from clinicians and
stakeholders through engagement activities. Seven clinical
subcommittees were convened through an open call for nominations
between March 17, 2017 and April 24, 2017, composed of nearly 150
clinicians affiliated with almost 100 specialty societies. These
subcommittees met at an in-person meeting and through webinars from May
2017 to January 2018 to select an episode group or groups to develop
and provide detailed clinical input on each component of episode-based
cost measures. These components included episode triggers and windows,
item and service assignment, exclusions, attribution methodology, and
risk adjustment variables.
As described in the CY 2018 Quality Payment Program final rule (82
FR 53645), we provided an initial opportunity for clinicians to review
their performance based on the new episode-based measures developed by
the clinical subcommittees in the fall of 2017 through national field
testing.
During field testing, we sought feedback from stakeholders on the
draft measure specifications, feedback report format, and supplemental
documentation through an online form. We received over 200 responses,
including 53 comment letters, during the field test feedback period. We
shared the feedback on the draft measure specifications with the
clinical subcommittees who considered it in providing input on measure
refinements after the end of field testing. A field testing feedback
summary report is publicly available at https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-
Programs/MACRA-MIPS-and-APMs/2018-field-testing-feedback-summary-
report.pdf.
To engage clinicians and stakeholders, we conducted extensive
outreach activities including hosting National Provider Calls (NPCs) to
provide information about the measure development process and field
test reports, and to give stakeholders the opportunity to ask
questions.
The new episode-based measures developed by the clinical
subcommittees were considered by the NQF-convened MAP, and were all
conditionally supported by the MAP, with the recommendation of
obtaining NQF endorsement. We intend to submit these episode-based
measures to NQF for endorsement in the future. The MAP provides an
opportunity for an interdisciplinary group of stakeholders to provide
input on whether the measures under consideration are attributable and
applicable to clinicians. The MAP also reviews measures for clinician
level feasibility, reliability, and validity. Following the successful
field testing and review through the MAP process, we proposed to add 8
episode-based measures listed in Table 36 as cost measures for the 2019
MIPS performance period and future performance periods (83 FR 35902).
The attribution methodology for these measures is discussed in
section III.I.3.h.(3)(b)(iv)(B) of this final rule. The detailed
specifications for these measures can be reviewed at qpp.cms.gov. These
specifications documents consist of (i) a methods document that
outlines the methodology for constructing the measures, and (ii) a
measure codes list file that contains the medical codes used in that
methodology. First, the methods document provides a high-level overview
of the measure development process, including discussion of the
detailed clinical input obtained at each step, and details about the
components of episode-based cost measures: Defining an episode group;
assigning costs to the episode group; attributing the episode group;
risk adjusting episode group costs; and aligning cost with quality. The
methods document also contains the detailed measure methodology that
describes each logic step involved in constructing the episode groups
and calculating the cost measure. Second, the measure codes list file
contains the codes used in the specifications, including the episode
triggers, exclusions, episode sub-groups, assigned items and services,
and risk adjustors.

Table 36--Episode-Based Measures Proposed for the 2019 MIPS Performance
Period and Future Performance Periods
------------------------------------------------------------------------
Measure topic Measure type
------------------------------------------------------------------------
Elective Outpatient Procedural.
Percutaneous Coronary
Intervention (PCI).
Knee Arthroplasty............ Procedural.
Revascularization for Lower Procedural.
Extremity Chronic Critical
Limb Ischemia.
Routine Cataract Removal with Procedural.
Intraocular Lens (IOL)
Implantation.
Screening/Surveillance Procedural.
Colonoscopy.
Intracranial Hemorrhage or Acute inpatient medical condition.
Cerebral Infarction.
Simple Pneumonia with Acute inpatient medical condition.
Hospitalization.
ST-Elevation Myocardial Acute inpatient medical condition.
Infarction (STEMI) with
Percutaneous Coronary
Intervention (PCI).
------------------------------------------------------------------------

[[Page 59769]]

The following is a summary of the public comments received on these
proposals and our responses:
Comment: Several commenters supported our proposed adoption of the
8 episode-based measures under the cost performance category for the
2021 MIPS payment year. These commenters noted their support for the
significant clinician input into the measures.
Response: We thank the commenters for their support.
Comment: Several commenters supported the development of episode-
based measures but expressed concern about including them in the MIPS
cost performance category for the 2019 MIPS performance period. They
recommended that there be additional time for clinicians to understand
and address their performance on the measures. One commenter indicated
that although the measures had been made available as part of field
testing in the fall of 2017, the feedback that was made available did
not facilitate action to improve on the part of the clinician. Another
commenter suggested that CMS use 2019 as a pilot year to better test
these new episode-based measures.
Response: We will continue to work to make clinicians more familiar
with the measures through education and outreach activities. For
example, we have held cost performance category webinars to help
clinicians understand the cost measures in use for the MIPS 2018
performance period, and expect to hold similar webinars in the future.
We believe that the extensive field testing activities conducted in the
fall of 2017 in combination with future education and outreach will
help to ensure clinicians will understand these episode-based measures
and what actions they could take to improve their performance in the
measures. We do not believe that an additional year of pilot testing is
necessary at this time given the field testing and extensive
involvement of clinicians in the development of these measures.
Comment: Many commenters requested more detailed feedback on cost
measures in order to improve their performance, stating that it is
difficult to manage costs without receiving data on the patients
attributed to them for purposes of the cost measures. Some commenters
requested that CMS provide information on attributed patients on a
regular basis, such as quarterly. Some commenters expressed concern
that in contrast with the Value Modifier program, CMS has not provided
detailed feedback on cost measures, such as identifying beneficiaries
and the services they received for the 2017 MIPS performance period.
One commenter also suggested the use of an alternative metric, such as
the average ratio of the observed cost compared to the expected cost,
as a final comparison for the episode-based measures, as they believe
this to be more informative and actionable for clinicians.
Response: We have conducted user research on the feedback provided
for the first year of MIPS. In addition to that feedback, we are also
reviewing the QRURs from the legacy VM program and conducting user
research about what is valuable within the information provided
historically. We are committed to maturing the feedback experience for
year 2 and may consider providing beneficiary-level data on cost
measures in the future. Additionally, while we are unsure whether or
not the average ratio of the observed cost to expected cost would be
more informative than our current feedback reports, we will continue to
monitor the information provided, and explore ways to provide
actionable information to clinicians as we develop the measures for the
cost performance category.
Comment: A few commenters supported the development and inclusion
of episode-based measures but expressed concern that measures for their
particular specialty or focus area, such as urology, chiropractic
medicine, and medical oncology, were not yet included. A few commenters
suggested that CMS continue to engage with stakeholders and provide a
transparent process as CMS continues to develop additional episode-
based measures. One commenter recommended that CMS develop or include
quality measures in tandem with cost measures to prevent unintended
consequences of attempts to reduce cost which could adversely affect
quality of care.
Response: We continue to work to develop new episode-based measures
that could be considered for inclusion in the cost performance category
in future years. We expect that future measures may apply to a greater
range of specialties and clinical areas, such as urology and the other
focus areas suggested by commenters. Section 1848(r)(2)(D)(i)(I) of the
Act requires us to establish care episode groups and patient condition
groups, which account for a target of an estimated one half of
expenditures under parts A and B with such target increasing over time
as appropriate. While we have developed some episode-based measures to
target that goal as required, we shall continue our work to develop
additional measures focusing on both additional specialty types as well
as consider the important issue of measuring both cost and quality. By
continuing to gather detailed clinician and expert input on episode-
based measures, such as through clinical subcommittees and technical
expert panels, we hope to identify and mitigate potential unintended
consequences at each stage of measure development and testing.
Comment: A few commenters expressed concern with the overall
process for adding episode-based measures to the MIPS program on an
annual basis. They indicated that while clinician input is valuable in
defining the measures, it is also of particular importance to have an
underlying structure for episode-based measures that defines
responsibility for patients as they cross between multiple episodes.
They opposed inclusion of episode-based measures until these issues are
addressed. Additionally, several commenters offered alternative
frameworks to consider in the future development of episode-based
measures, including moving towards a tool that offers a multi-payer
perspective. One commenter urged CMS to develop episode-based measures
that are specific to discrete episodes of care. A few commenters
encouraged CMS to consider other factors when developing episode-based
measures including Activities of Daily Living (ADLs), counter quality
measures, patient specific pricing, and medical innovations.
Response: We rely on a comprehensive framework and systematic
process for creating episode-based measures that account for the roles
and responsibilities of individual clinicians in the care of individual
patients experiencing specific health conditions. This framework has
been applied in constructing all of the new cost measures for use in
MIPS, and in revising episode groups that had been developed under
section 1848(n)(9)(A) of the Act. Our current process includes: (1) A
transparent conceptual framework for creating episodes of care that
assigns costs for patients to those clinicians with the ability to
influence those costs; (2) a mechanism for incentivizing high quality
treatment that lowers preventable high cost future adverse health
events; and (3) a data-driven stakeholder input process for acquiring
and implementing clinical input that ensures clinical face validity and
actionability of constructed episode-based cost measures. This
framework was developed in part based on stakeholder comments on
measures in the Value Modifier program and overcomes the fundamental
shortcomings of earlier episode grouping approaches previously studied

[[Page 59770]]

by CMS. Shortcomings of previously studied episode grouping approaches
included lack of actionability arising from the unpredictable and
clinically inappropriate assignment of costs, limited relevance as
episode constructions did not focus on the role of attributed
clinicians in providing patient care, and limited transparency arising
from the use of complicated software algorithms.
Our conceptual framework provides a comprehensive foundation for
episode-based measures that can be used to incentivize high-value care
by attributed clinicians at each stage of the patient care continuum,
and allows for progressively adding new episode-based measures in a
logically cohesive and consistent manner. The framework involves three
distinct types of episode groups: Procedural, acute inpatient medical
condition, and chronic. Procedural episode groups are triggered by
performance of a major procedure, acute inpatient medical condition
episode groups are triggered by evaluation and management claims during
hospitalizations with specific DRGs, and chronic condition episode
groups are triggered by evaluation and management claims with
particular diagnoses. Attribution is determined by the clinician(s)
involved in the triggering claims, with consistent rules within each
type of episode group. Services, and their associated costs, are
assigned to an episode based on a clinical determination of whether a
service is under the influence of the attributed clinician (for
example, routine follow-up care or adverse health outcomes such as a
readmission). Clinical determinations of service assignment are made
using common criteria and methods across episode groups, to encourage
distinctions in service assignment and reflect differences in clinical
influence across episode groups. Risk adjustment employs a common
starting point of the CMS-HCC model across episode groups, but risk
adjustment models can be enhanced by the use of risk factors
specifically adapted for each episode group. This allows, for instance,
for adjustments to be made for an acute condition episode group based
on whether the condition is a stand-alone presentation of the condition
versus the exacerbation of an ongoing chronic condition. The framework
also allows for complete stratification in risk adjustment through the
use of episode sub-groups, with the definition of sub-groups (such as
unilateral vs. bilateral) being based on common principles across
episode groups. Episodes from distinct episode groups can overlap with
one another to ensure that each clinician treating a patient with
multiple health issues has incentives for providing high value care.
When a given service is clinically related to only one overlapping
episode, it is assigned only to that one. When a service is clinically
related to two overlapping episodes, it is assigned to both to ensure
joint accountability. Since each episode's cost is compared to a risk-
adjusted expected cost only for other episodes from the same episode
group, there is no issue of double counting. This approach allows for
development of distinct episode groups that cover a patient's care
continuum, including an underlying chronic condition as well as a
procedure or treatment for an exacerbation. As an example, a patient
receiving chronic care for coronary artery disease (CAD) (a chronic
episode) could have an acute incidence of STEMI requiring PCI for
stabilization (an acute inpatient medical condition episode), and due
to having severe CAD could later receive a coronary artery bypass graft
(CABG) procedure (a procedural episode). This logically, cohesive
framework for episode group development avoids a series of challenges
raised by previously studied episode grouping approaches that assign
services to only a single episode, including lack of transparency and
predictability in what an attributed clinician will be held accountable
for at the beginning of an episode. For information on how this
framework has been operationalized, refer to the measure specifications
available at https://qpp.cms.gov.
Using this conceptual framework, we have created a concrete process
for developing new measures over time. To prioritize the areas for
development of the new cost measures, our measure development
contractor convened a clinical committee, comprised of over 70
clinicians affiliated with over 50 specialty societies that provided
input necessary to develop a public posting of 117 episode groups for
development in December 2016. We then used criteria vetted by a
standing technical expert panel--comprised of 19 clinicians, health
researchers, and representatives of patient advocacy organizations--to
divide these 117 episode groups into 18 clinical areas. The
prioritization criteria focused on identifying areas where potential
episode-based measures could affect the highest number of beneficiaries
and clinicians, address particularly high cost procedures and
conditions, provide an opportunity for improvement, and best align with
quality measures.
Our measure development contractor has and is continuing to convene
clinical subcommittees for each of the priority clinical areas. The
composition of a subcommittee for an area principally consists of
practicing clinicians who are candidates for attribution of episode-
based measures developed for that area. Each clinical subcommittee
prioritizes specific episode measures for development within its area
based on the criteria above. The structure for developing specific cost
measures relies on a systematic data-based conceptual framework for
triggering logic, cohort definition, attribution, and cost assignment.
For the 8 episode-based measures discussed in this rule, nearly 150
clinicians affiliated with 98 specialty societies participated in the
clinical subcommittees in the creation of these measures. After
positive reception of the initial development process, 267 clinicians
affiliated with more than 120 specialty societies are now participating
in the clinical subcommittees and workgroups developing 11 additional
episode-based cost measures. The structure of episode-based cost
measure development provides a vehicle for continued stakeholder
engagement as additional measures are developed in the future.
Comment: A few commenters recommended that episode-based measures
not be included in the MIPS cost performance category if the measures
have not been endorsed by the NQF or supported by the MAP. They stated
that the NQF process gives important insights into the reliability,
validity, and usability of measures.
Response: The episode-based measures were reviewed by the MAP and
received the recommendation of ``conditional support for rulemaking,''
with the MAP recommending that the measures be submitted for NQF
endorsement. This review provided stakeholders with additional public
comment opportunities, which the MAP considered along with submission
materials regarding the scientific acceptability, reliability,
validity, and usability of the measures. We intend to submit the
episode-based measures for NQF endorsement in an upcoming review cycle.
Comment: One commenter expressed concern that particular episode-
based measures did not properly account for risk because of the nature
of their construction and lack of clinical data. Specifically, this
commenter stated that a combined measure of intracranial hemorrhage and
cerebral infraction

[[Page 59771]]

would produce distortions in results. This commenter also stated that
risk adjustment for this measure did not include a measure of stroke
severity. Another commenter expressed uncertainty about the risk
adjustment methodology and also suggested the use of both inpatient and
outpatient claims data to obtain a complete understanding of the
patient's risk factors. One commenter suggested excluding Implantable
Cardioverter Defibrillator (ICD) implantation MS-DRGs (222-227) from
the Elective Outpatient PCI and STEMI with PCI measures to ensure there
are no adverse incentives to providing a service that is both covered
and clinically indicated. One commenter expressed concern that the
episode-based measure for Revascularization for Lower Extremity Chronic
Critical Limb Ischemia should have a longer measurement period. One
commenter requested that post-discharge events unrelated to the initial
pneumonia hospitalization and any hospice costs be excluded for the
Simple Pneumonia episode-based measure. The same commenter also stated
that new episodes for the same measure should not be started for a
patient if they already have an ongoing episode.
Response: We understand the interest in risk adjustment and other
aspects of measure construction. To summarize, the risk adjustment for
the eight episode-based measures includes risk adjustors from the CMS-
HCC model and additional measure-specific risk adjustors recommended by
the Clinical Subcommittee for the measure. Risk adjustors are defined
using the beneficiary's Medicare claims history (including inpatient,
outpatient, and Part B Physician/Supplier claims) during the period
prior to the start of the episode. Claims from the triggering
hospitalization or on the triggering Part B Physician/Supplier claim
are typically not included, as we understand it may be difficult to
discern which claims are due to complications and which were already
present at the initiation of the episode. We believe that utilizing the
claims from the look back window adequately identifies patient
comorbidities. To address the specific comments, we believe that the
Intracranial Hemorrhage and Cerebral Infarction measure accurately
assesses clinician cost performance as there are separate sub-groups
for Intracerebral Hemorrhage and Cerebral Infarction such that patients
within each sub-group are compared only with each other (that is, a
patient being treated for Cerebral Infarction would only be compared to
other patients being treated for Cerebral Infarction). The risk
adjustors for this measure were developed with significant input from a
Neuropsychiatric Disease Management Clinical Subcommittee, which
recommended specific risk adjustors that include MS-DRG severity for
Intracranial Hemorrhage or Cerebral Infarction and Nonspecific
Cerebrovascular Disorders. Additional risk adjustors were included to
account for comorbidities that could lead to worse outcomes such as
aphasia and dysphagia. However, measures of stroke severity such as the
NIH stroke scale were not included in the risk adjustment model to
avoid possible unintended consequences (for example, coding of higher
severity for improvement of individual episode risk adjustment) and to
avoid penalizing clinicians who do not code for severity, especially
since ICD-10-CM codes for NIH Stroke Scale have only been operational
since October 2017. The Revascularization for Lower Extremity Chronic
Critical Limb Ischemia measure has a 30-day pre-trigger period and a
90-day post-trigger period. This episode window was determined through
extensive input from a Peripheral Vascular Disease Management Clinical
Subcommittee, which we believe to be an appropriate length of time for
which the attributed clinician can reasonably influence services. The
measure specifications, including the post-discharge assigned services,
for the Simple Pneumonia with Hospitalization measure were developed
with significant clinical input from the Pulmonary Disease Management
Clinical Subcommittee, which only assigned services they believed the
attributed clinician could reasonably influence. For this reason, the
costs associated with the hospice setting are not assigned to Simple
Pneumonia with Hospitalization episodes. We will conduct annual
evaluations to review the continued accuracy of the measure
specifications. Finally, we do not exclude episodes if a patient
already qualifies for another episode since we believe that allowing
for overlapping episodes incentivizes communication and care
coordination as a patient progresses through the care continuum. For
example, if a patient is re-hospitalized for pneumonia after an initial
pneumonia episode, this triggers two separate episodes of care for
pneumonia. The risk adjustment model adjusts for differences in
clinical complexity at the time each episode begins. This ensures that
the attributed clinicians managing each hospitalization face analogous
incentives to provide the patient high value care. The assigned
services for the STEMI with PCI and Elective Outpatient PCI measures
were developed with input from the Cardiovascular Disease Management
Clinical Subcommittee, with the goal of capturing complications of
Myocardial Infarction (MI) or Heart Failure (HF) admissions. Given this
clinical intent of the measure, we believe that MS-DRGs with MI or HF
in the measure (MS-DRGs 222-223: Defib with Cath with MI/HF) are
appropriate to include as assigned services. We agree, however, with
the comment about removing assignments of the MS-DRGs without MI or HF
(MS-DRGs 224-225: Defib with Cath without MI/HF and MS-DRGs 226-227:
Defib without Cath without MI/HF), as these are more likely to be
elective ICD placements. Given the scope of the measure, we believe it
is appropriate to assign services that are part of an admission for MI
or HF, while excluding services that are elective. To maintain a
consistent framework across all measures, we are implementing this
revision where relevant in STEMI with PCI, Elective Outpatient PCI, and
Revascularization for Lower Extremity Chronic Critical Limb Ischemia.
Comment: One commenter expressed concern with the possibility of
high cost variation for some episode-based measures depending on the
codes that trigger the episodes or the place of service in which an
episode is triggered. To account for this variation, the commenter
suggested incorporating a sub-group based on the triggering DRG code
for the Intracranial Hemorrhage or Cerebral Infarction measure and the
STEMI with PCI measure, a sub-group based on triggering procedure code
for the Elective Outpatient PCI measure, and a place of service sub-
group for the Revascularization for Lower Extremity Chronic Critical
Limb Ischemia measure and Screening/Surveillance Colonoscopy measure.
Response: The measure specifications, including the episode
triggers and the sub-groups for each measure, were determined with
significant clinical input from the Clinical Subcommittees that
developed each episode-based measure. To adjust for patient differences
outside attributed clinicians' influence, the Clinical Subcommittees
could choose to risk adjust for a specific patient factor or sub-group
by that factor. Risk adjustment ensures that a measure accounts for
average cost differences associated with the specific factor, while
sub-grouping involves estimating an entirely separate risk adjustment
model for patients with that factor. Sub-grouping is only appropriate

[[Page 59772]]

in cases where a sufficient number of episodes are present in the sub-
population to ensure a statistically meaningful model and where a
separate model for the sub-population is necessary. Balancing these
considerations, the Clinical Subcommittees addressed concerns raised by
the commenter by: Including indicators for MS-DRG in risk adjustment
models for the Intracranial Hemorrhage or Cerebral Infarction measure
and the STEMI with PCI measure to reflect the presence of Complication
or Comorbidity (CC) or Major Complication or Comorbidity (MCC); and
including place of service factors in risk adjustment models for the
Revascularization for Lower Extremity Chronic Critical Limb Ischemia
measure and the Screening/Surveillance Colonoscopy measure. For the
Elective Outpatient PCI measure, the current inclusion of other risk
adjustment factors is designed to control for factors outside of the
clinician's influence that may dictate the particular triggering
procedure used.
Comment: Several commenters expressed support for the episode-based
measure development process implemented by CMS that incorporates
significant stakeholder input as well as support for the measures. One
commenter commended CMS for convening the Clinical Subcommittees,
specifically noting that they believed members of the subcommittee that
developed the Screening/Surveillance Colonoscopy measure were part of a
successful and deliberative process. Two commenters also supported the
Routine Cataract with IOL Implantation measure, stating the measure
accurately reflected the costs of the procedure and will provide
actionable data to clinicians. Another commenter expressed appreciation
for the pace of the development process and urged CMS to continue this
level of engagement with stakeholders in other areas of the Quality
Payment Program.
Response: We recognize the importance of clinician input in
developing episode-based measures that provide actionable data and aim
to continue this level of engagement in the development of future
episode-based measures for MIPS.
Comment: One commenter supported the total per capita cost measure
and stated it is the best initial metric for assessing the cost-
effectiveness of primary care providers while fulfilling MACRA's
mandate to evaluate a primary care provider's cost performance.
Response: We agree that this measure is important as a measure of
the overall cost of care, even as we develop episode-based measures
which are also important measures of the cost of care.
Comment: Several commenters opposed the continued inclusion of the
total per capita cost measure and the MSPB measure in the cost
performance category. They stated that the measures included all
services provided to a patient, even those for which the attributed
clinician could not control. One commenter requested that these
measures only be applied to primary care clinicians and not to
specialists. Finally, one commenter expressed concerns with how total
per capita cost measure has not yet been endorsed by NQF, and MSPB
measure has only been endorsed at the facility-level.
Response: While we appreciate the interest in the total per capita
cost and MSPB measures' NQF endorsement status, we continue to believe
that these measures are tested and reliable for Medicare populations
and provide an important measurement of clinician cost performance (82
FR 53644) while we continue to develop episode-based measures that
precisely identify services that are part of an episode that could be
considered directly under the control of a clinician. Versions of the
total per capita cost and MSPB measures were included in the QRURs and
used in the VM for many years before the implementation in MIPS. These
measures have an important place in cost measurement given that the
episode-based measures will only apply to a subset of clinicians at
this time.
The total per capita cost measure uses a primary care attribution
method in which a specialist would not be attributed a patient unless
that patient did not see a primary care clinician (based on the
Medicare specialty) during the year. For some patients who do not see a
primary care clinician in a year, a specialist may serve as a primary
care clinician due to an underlying disease or condition which the
specialist focuses on. For the MSPB measure, we do not believe it is
appropriate to limit attribution to primary care clinicians as
specialists may perform procedures or manage patients in the hospital
and can have a significant influence on the overall spending during the
hospitalization.
Both the total per capita cost and MSPB measures are being refined
as part of the measure maintenance and re-evaluation process,
incorporating substantial stakeholder input. We are completing an
extensive outreach initiative in the fall of 2018 to share performance
information with clinicians as part of field testing, a part of measure
re-evaluation. After considering the stakeholder feedback on these
refinements, we may propose the re-evaluated measures for use in MIPS
to replace the current versions of the measures in the program.
Comment: Several commenters expressed concern about the risk and
specialty adjustment methods used in the measures that are part of the
cost performance category. In particular, several commenters stated
that measures do not appropriately account for sociodemographic status,
which can drive differences in average episode costs. Additionally,
commenters noted that measures did not take into account the risks
associated with complex or dual-eligible patients or patients seen by
certain specialists. Another noted the lack of risk-adjustment for
cancer treatment. One commenter also expressed concern about the
differences in case-mix across specialties for a given measure,
specifically STEMI with PCI. The commenter stated that under this
measure, hospitalists may be attributed episodes that include more
medically complex patients who require post-ICU care on a general
medicine floor, making these hospitalists appear to be costlier than
other clinicians.
Response: We understand stakeholders' concerns regarding risk
adjustment for social risk factors and dual eligible status. As we have
previously stated, we are concerned about holding clinicians to
different standards for the outcomes of their patients with social risk
factors, because we do not want to mask potential disparities. We
believe that the path forward should incentivize improvements in health
outcomes for disadvantaged populations while ensuring that
beneficiaries have adequate access to excellent care. We thank
commenters for this important feedback and will continue to consider
options to account for social risk factors that would allow us to view
disparities and potentially incentivize improvement in care for
patients and beneficiaries. We recognize the concern regarding risk
adjusting for complex patients, including those with cancer treatment,
and regarding the variation in case-mix across specialties for a given
episode. Our risk adjustment methodology, which employs a common
starting point of the CMS-HCC model across episode groups and can
include the use of risk factors specifically adapted for each episode
group is designed to account for patient comorbidities that predict a
complex hospitalization and lead to higher costs that are outside the
influence of attributed clinicians, regardless of

[[Page 59773]]

which specialty designations those clinicians choose to identify.
Comment: Several commenters requested that certain clinicians be
excluded or included in the cost performance category on the basis of
their type of practice, particularly non-patient facing clinicians.
Response: We have established a policy to assign a zero percent
weight to the cost performance category if there are not sufficient
measures applicable and available to a MIPS eligible clinician (see,
for example, 81 FR 77322 through 77325). We believe it is possible that
a clinician may not have sufficient cost measures applicable or
available to them based on their specialty or type of practice,
including clinicians who are non-patient facing. We continue to work to
expand the reach of the cost performance category to as many clinicians
as possible, including non-patient facing clinicians in accordance with
section 1848(q)(2)(C)(iv) of the Act.
After consideration of the public comments, we are finalizing our
proposal to include the 8 episode-based measures listed in Table 36 in
the cost performance category beginning with the 2019 MIPS performance
period with a modification to the STEMI with PCI, Elective Outpatient
PCI, and Revascularization for Lower Extremity Chronic Critical Limb
Ischemia episode-based measures to remove assignments of the MS-DRGs
without MI or HF (MS-DRGs 224-225: Defib with Cath without MI/HF and
MS-DRGs 226-227: Defib without Cath without MI/HF).
(iii) Reliability
In the CY 2017 Quality Payment Program final rule (81 FR 77169
through 77170), we finalized a reliability threshold of 0.4 for
measures in the cost performance category. We seek to ensure that MIPS
eligible clinicians are measured reliably. In the CY 2017 Quality
Payment Program final rule, we finalized a case minimum of 20 for the
episode-based measures specified for the 2017 MIPS performance period
(81 FR 77175). We examined the reliability of the proposed 8 episode-
based measures listed in Table 36 at various case minimums and found
that all of these measures meet the reliability threshold of 0.4 for
the majority of clinicians and groups at a case minimum of 10 episodes
for procedural episode-based measures and 20 episodes for acute
inpatient medical condition episode-based measures. Furthermore, these
case minimums would balance the goal of increased reliability with the
goal of adopting cost measures that are applicable to a larger set of
clinicians and clinician groups. Our analysis indicated that the case
minimum for procedural episode-based measures could be lower than that
of acute inpatient medical condition episode-based measures while still
ensuring reliable measures.
Table 37 presents the percentage of TINs and TIN/NPIs with 0.4 or
higher reliability, as well as the mean reliability for the subset of
TINs and TIN/NPIs who met the proposed case minimums of 10 episodes for
procedural episode-based measures and 20 episodes for acute inpatient
medical condition episode-based measures for each of the proposed
episode-based measures. Each row in Table 37 provides the percentage of
TINs and TIN/NPIs who had reliability of 0.4 or higher among all the
TINs and TIN/NPIs who met the case minimum for that measure during the
study period (6/1/2016 to 5/31/2017).

Table 37--Percentage of TINs and TIN/NPIs With 0.4 or Higher Reliability From June 1, 2016 to May 31, 2017 at
Proposed Case Minimums
----------------------------------------------------------------------------------------------------------------
Percentage Percentage TIN/
TINs with 0.4 Mean NPIs with 0.4 Mean
Measure name or higher reliability or higher reliability
reliability for TINs reliability for TIN/NPIs
(%) (%)
----------------------------------------------------------------------------------------------------------------
Elective Outpatient Percutaneous Coronary 100.0 0.73 84.1 0.53
Intervention (PCI).............................
Knee Arthroplasty............................... 100.0 0.87 100.0 0.81
Revascularization for Lower Extremity Chronic 100.0 0.74 100.0 0.64
Critical Limb Ischemia.........................
Routine Cataract Removal with Intraocular Lens 100.0 0.95 100.0 0.94
(IOL) Implantation.............................
Screening/Surveillance Colonoscopy.............. 100.0 0.96 100.0 0.93
Intracranial Hemorrhage or Cerebral Infarction.. 100.0 0.70 74.9 0.48
Simple Pneumonia with Hospitalization........... 100.0 0.64 31.8 0.40
ST-Elevation Myocardial Infarction (STEMI) with 100.0 0.59 100.0 0.59
PCI............................................
----------------------------------------------------------------------------------------------------------------

Based on this analysis, we proposed at Sec. 414.1350(c)(4) and (5)
a case minimum of 10 episodes for the procedural episode-based measures
and 20 episodes for the acute inpatient medical condition episode-based
measures beginning with the 2019 MIPS performance period (83 FR 35904).
We stated that these case minimums would ensure that the measures meet
the reliability threshold for groups and individual clinicians. We
stated that we believe that the proposed case minimums for these
procedural and acute inpatient medical condition episode-based measures
would achieve a balance between several important considerations. In
order to help clinicians become familiar with the episode-based
measures as a robust and clinician-focused form of cost measurement, we
want to provide as many clinicians as possible the opportunity to
receive information about their performance on reliable measures. This
is consistent with the stakeholder feedback that we have received
throughout the measure development process. We stated that we believe
that calculating episode-based measures with these case minimums would
accurately and reliably measure the performance of a large number of
clinicians and clinician group practices.
We stated that we recognize that the percentage of TIN/NPIs with
0.4 or greater reliability for the Simple Pneumonia with
Hospitalization measure, while still meeting our reliability threshold,
is somewhat lower than that of the other proposed acute inpatient
medical condition episode-based measures, as well as all of the
proposed procedural episode-based measures. For this reason, we
considered an alternative case minimum of 30 for both TIN/NPIs and TINs
for this measure. At this case minimum, 100 percent of TIN/NPIs would
have 0.4 or greater reliability and the mean reliability would increase
to 0.49 for TIN/NPIs and 0.70 for TINs. However, the number of TINs and
TIN/NPIs that would meet the case minimum for this important measure
would decrease by 29 percent for TINs and by 84 percent for TIN/NPIs.
We invited comments on

[[Page 59774]]

this alternative case minimum for TIN/NPIs and TINs for the Simple
Pneumonia with Hospitalization episode-based measure.
We previously finalized a case minimum of 35 for the MSPB measure
(81 FR 77171), 20 for the total per capita cost measure (81 FR 77170),
and 20 for the episode-based measures specified for the 2017 MIPS
performance period (81 FR 77175). We proposed to codify these final
policies under Sec. 414.1350(c) (83 FR 35904).
In general, higher case minimums increase reliability, but also
decrease the number of clinicians who are measured. We aim to measure
as many clinicians as possible in the cost performance category. Some
clinicians or smaller groups may never see enough patients in a single
year to meet the case minimum for a specific episode-based measure. For
this reason, we solicited comment on whether we should consider
expanding the performance period for the cost performance category
measures from a single year to 2 or more years in future rulemaking. We
believe this would allow us to more reliably measure a larger number of
clinicians. However, we are also concerned that expanding the
performance period would increase the time between the measurement of
performance and the application of the MIPS payment adjustment. In
addition, it would take a longer period of time for us to introduce new
cost measures as we would expect to adopt them through rulemaking prior
to the beginning of the performance period.
The following is a summary of the public comments received on these
proposals and our responses:
Comment: Many commenters expressed concern with the reliability
thresholds that we use to inform the determination of case minimums in
the cost performance category. Several of these commenters suggested
that measures should have case minimums that would reflect 0.8
reliability for all TINs and TIN/NPI combinations. One commenter stated
that using a low reliability threshold would result in measuring the
acuity of patients as opposed to the performance of a clinician.
Another commenter suggested that we consider whether a standard case
minimum for all episode group should continue to be set or case
minimums should be set accordingly for each individual measure. One
commenter also suggested increasing to a 20 episode case minimum for
procedural episode-based measures.
Response: Because we aim to balance the need for consistent program
standards with ensuring that measures are reliable, we proposed to set
a different case minimum for the procedural and acute inpatient medical
condition episode-based measures. We aim to measure cost for as many
clinicians as possible, and limiting measures to reliability of 0.7 or
0.8 would result in few individual clinicians with attributed cost
measures. In addition, a 0.4 reliability threshold ensures moderate
reliability for most MIPS eligible clinicians and group practices that
are being measured on cost. Under the proposed case minimum of 10
episodes for the procedural episode-based measures, the reliability of
the measures already exceeds the 0.4 reliability threshold we have
previously established, with most having higher than 0.7 reliability.
Using a 20 episode case minimum, while having a slight increase in
reliability, will reduce clinician coverage. Therefore, retaining the
proposed case minimum of 10 episodes for the procedural measures allows
us to maximize the number of clinicians covered by these measures,
while still exceeding the 0.4 moderate reliability threshold. We will
continue to evaluate reliability as we develop new measures and propose
them for inclusion in MIPS in future rulemaking.
Comment: Several commenters supported our alternative proposal for
a case minimum of 30 for the Simple Pneumonia with Hospitalization
measure. The commenters stated that using a more reliable measure would
be preferred over measuring more clinicians.
Response: We agree that our proposed alternative case minimum of 30
episodes for the Simple Pneumonia with Hospitalization measure would
have slightly higher reliability, but we also believe that maintaining
a consistent case minimum across all acute inpatient medical condition
episode-based measures would accurately and reliably assess cost
measure performance for a large number of clinicians and clinician
groups. We believe it is in the interests of MIPS participants,
particularly specialists who treat patients for this condition, to have
this new episode-based measure available to them. A consistent case
minimum for acute inpatient medical condition episode-based measures
would also make it easier for clinicians to understand because it
establishes cohesiveness across the different measures as stakeholders
are still becoming familiar with these new measures. The mean
reliability of the Simple Pneumonia with Hospitalization measure at 20
episodes exceeds the 0.4 reliability threshold (indicating moderate
reliability) for TINs and meets that threshold for TIN/NPIs.
Comment: One commenter stated that small practices are less
reliably measured by cost measures and that it will be difficult for
small practices to analyze cost data in order to improve.
Response: While we have not examined the issue of practice size in
relation to the reliability of the cost measures, we have examined the
issue of case size in relation to the reliability of cost measures. The
results of the analysis of episode-based cost measures can be found in
our National Summary Data Report on Eight Wave 1 Episode-Based Cost
Measures at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-
Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/
Updated-2017-National-Summary-Data-Report.pdf. To some degree, the size
of a practice correlates with the case size for cost measures, as an
individual clinician can only see so many patients. We believe that
establishing case minimums that are based on moderate reliability allow
us to measure all clinicians and groups that meet those case minimums.
We note that the scores on the measures in the cost performance
category are only a component of the MIPS final score, which also
includes a small practice bonus available within the quality
performance category to accommodate the issues that may be faced by
small practices.
After consideration of the public comments, we are finalizing our
proposed case minimum of 10 episodes for the procedural episode-based
measures and 20 episodes for the acute inpatient medical condition
episode-based measures beginning with the 2019 MIPS performance period
at Sec. 414.1350(c)(4) and (5) as proposed. We are also finalizing our
proposal to codify our previously finalized case minimum of 35 for the
MSPB measure, 20 for the total per capita cost measure, and 20 for the
episode-based measures specified for the 2017 MIPS performance period
at Sec. 414.1350(c) as proposed. We will take the comments we received
on expanding the performance period for measures in the cost
performance category into account for future rulemaking.
(iv) Attribution
(A) Attribution Methodology for Cost Measures
In the CY 2017 Quality Payment Program final rule (81 FR 77168
through 77169; 77174 through 77176), we adopted final policies
concerning the attribution methodologies for the total

[[Page 59775]]

per capita cost measure, the MSPB measure, and the episode-based
measures specified for the 2017 MIPS performance period in addition to
an attribution methodology for individual clinicians and groups. We
proposed to codify these final policies under Sec. 414.1350(b).
The following is a summary of the public comments received on these
proposals and our responses:
Comment: Several commenters expressed concern with the attribution
methods finalized in the 2017 Quality Payment Program final rule (81 FR
77168 through 77169), which we proposed to codify. These commenters
stated that it was unclear to clinicians which patients would be
attributed to them. They recommended a number of methods to improve
this process, such as offering feedback on the patients that may be
attributed to a clinician at some time during the performance period or
allowing clinicians to define attribution with the use of patient
relationship codes.
Response: We will continue to look at ways to facilitate the
engagement of clinicians in the measures in the cost performance
category and will look into offering as much information as is feasible
to clinicians.
Comment: Several commenters expressed concern with the attribution
methodology for the total per capita cost measure that we finalized in
the CY 2017 Quality Payment Program final rule (81 FR 77168 through
77169), which we proposed to codify. In particular, they expressed
concerns with the identification of clinicians such as nurse
practitioners and physician assistants as primary care clinicians under
this methodology, because many of them work in specialist practices.
Response: We believe that attribution methods that include nurse
practitioners (NP) and physician assistants (PA) as primary care
clinicians best represents the role they play in clinical care. Under
the attribution methodology for the total per capita cost measure, a
patient who saw a primary care physician more often than an NP or PA in
a specialty practice would be attributed to that primary care
physician. As we have observed in rulemaking for the Value Modifier (79
FR 67961), including NPs and PAs in the first step of attribution in
the total per capita care cost measure did not significantly affect the
attribution of patients.
Comment: Several commenters expressed concern with the attribution
methods used for the MSPB measure for which we finalized policy in the
CY 2017 Quality Payment Program final rule (81 FR 77168 through 77169)
and which we proposed to add to regulatory text. Many of the commenters
expressed concern that the method of attribution was assigning patients
to non-patient facing specialists such as pathologists and radiologists
because they may provide expensive services, but do not provide overall
care management for the patient. A few commenters requested that non-
patient facing clinicians not be attributed this measure.
Response: We believe that the MSPB measure continues to be an
important measure of the overall cost of care for a patient and the
clinician who provides the plurality of care. We believe that a
clinician who provides the plurality of care in a hospital has
opportunities to affect the cost of care for that patient. In some
cases that may be a non-patient facing clinician, who in order to
provide the plurality of care, would have provided a significant amount
of service to a hospitalized patient.
After consideration of the public comments, we are finalizing our
proposal to codify the previously adopted final policies at Sec.
414.1350(b) as proposed.
(B) Attribution Rules for the Episode-Based Measures
In section III.I.3.h.(3)(b)(ii) of this final rule, we finalized 8
episode-based measures for the cost performance category for the 2019
MIPS performance period and future performance periods, which can be
categorized into two types of episode groups: Acute inpatient medical
condition episode groups, and procedural episode groups. These measures
only include items and services that are related to the episode of care
for a clinical condition or procedure (as defined by procedure and
diagnosis codes), as opposed to including all services that are
provided to a patient over a given period of time. The attribution
methodology will be the same for all of the measures within each type
of episode groups--acute inpatient medical condition episode groups and
procedural episode groups. Our approach to attribution will ensure that
the episode-based measures reflect the roles of the individuals and
groups in providing care to patients.
For acute inpatient medical condition episode groups specified
beginning in the 2019 performance period, we proposed at Sec.
414.1350(b)(6) to attribute episodes to each MIPS eligible clinician
who bills inpatient evaluation and management (E&M) claim lines during
a trigger inpatient hospitalization under a TIN that renders at least
30 percent of the inpatient E&M claim lines in that hospitalization (83
FR 35905). We stated that a trigger inpatient hospitalization is a
hospitalization with a particular MS-DRG identifying the episode group.
These MS-DRGs, and any supplementary trigger rules, are identified in
the measure specifications posted at qpp.cms.gov. The measure score for
an individual clinician (TIN/NPI) is based on all of the episodes
attributed to the individual. The measure score for a group (TIN) is
based on all of the episodes attributed to a TIN/NPI in the given TIN.
If a single episode is attributed to multiple TIN/NPIs in a single TIN,
the episode is only counted once in the TIN's measure score. We stated
that we believe that establishing a 30 percent threshold for the TIN
would ensure that the clinician group is collectively measured across
all of its clinicians who are likely responsible for the oversight of
care for the patient during the trigger hospitalization.
This proposed attribution approach differs from the attribution
approach previously established for episode-based measures for acute
inpatient medical conditions specified for the 2017 performance period
in the CY 2017 Quality Payment Program final rule (81 FR 77174 through
77175). The previous approach attributed episodes to TIN/NPIs who
individually exceed the 30 percent E&M threshold, while excluding all
episodes where no TIN/NPI exceeds the 30 percent threshold. Throughout
the measure development process, stakeholders have discussed the team-
based nature of acute care, in which multiple clinicians share
management of a patient during a hospital stay. The previous approach
outlined in the CY 2017 Quality Payment Program final rule (81 FR 77174
through 77175) does not capture patients' episodes when a group
collaborates to manage a patient but no individual clinician exceeds
the 30 percent threshold. Based upon stakeholder feedback, our proposed
approach emphasizes team-based care and expands the measures' coverage
of clinicians, patients, and cost.
We provided an example to illustrate the proposed attribution rules
for acute inpatient medical condition episode groups in the proposed
rule (83 FR 35905).
For procedural episode groups specified beginning in the 2019 MIPS
performance period, we proposed at Sec. 414.1350(b)(7) to attribute
episodes to each MIPS eligible clinician who renders a trigger service
as identified by HCPCS/CPT procedure codes (83 FR 35905). These trigger
services are identified in the measure specifications posted at
qpp.cms.gov. We stated that the measure score for an individual

[[Page 59776]]

clinician (TIN/NPI) is based on all of the episodes attributed to the
individual. The measure score for a group (TIN) is based on all of the
episodes attributed to a TIN/NPI in the given TIN. If a single episode
is attributed to multiple TIN/NPIs in a single TIN, the episode is only
counted once in the TIN's measure score. We stated that we believe this
approach best identifies the clinician(s) responsible for the patient's
care. This attribution method is similar to that used for procedural
episode-based measures in the 2017 MIPS performance period but more
clearly defines that the services must be provided during the episode
and how we would address instances in which two NPIs in the same TIN
provided a trigger service.
The following is a summary of the public comments received on these
proposals and our responses:
Comment: One commenter supported our proposed attribution methods
for the procedural and acute inpatient medical condition episode-based
measures.
Response: We appreciate the support of the commenter.
Comment: A few commenters agreed with the importance of shared
accountability in attribution, with one commenter noting that they
believed the proposed methodology represented a novel approach to this
shared accountability. However, a few commenters opposed our proposed
attribution methodology for acute inpatient medical condition episode-
based measures. A few commenters recommended that the required
percentage be increased. A few commenters expressed concern that a
single patient could be attributed to many clinicians in a practice if
they participated in MIPS as individuals under this proposed
attribution method. This commenter stated that a clinician billing for
a single service during a hospitalization could not be expected to have
a significant effect on costs. A few commenters stated that this change
in attribution methodology had been made following the episode-based
measure field testing and could undercut the viability of measures
established with clinical input.
Response: We appreciate the support for the emphasis on team-based
care and shared accountability in the attribution methodology. We also
appreciate the interest in increasing the E&M threshold percentage as
part of the attribution methodology for the acute inpatient medical
condition episode-based measures. While there is interest in increasing
the E&M threshold and concern about the impact of the proposed
attribution methodology on clinicians participating in MIPS as
individuals, we believe that the methodology as proposed appropriately
balances the interest in team-based care and enabling as many
clinicians as possible to be attributed to these new acute inpatient
medical condition episode-based measures. Specifically, we believe that
an E&M threshold requirement of 30 percent reflects stakeholder input
throughout the measure development process to reasonably reflect the
nature of care in an inpatient setting, and it is in the interests of a
large number of clinicians and clinician groups to be able to access
these episode-based measures. We disagree that the proposed methodology
undercuts the viability of the episode-based measures. Each component
of the measures reflects feedback that the measure development
contractor has gathered from clinical subcommittees, a technical expert
panel, and public comments, including during field testing in 2017. We
believe that the changes made to the attribution methodology after
field testing reflect the purpose of such testing--which we believe
goes beyond the typical testing associated with many performance
measures--to reveal issues and to gather stakeholder feedback to inform
potential measure refinements. This included feedback on the importance
of incorporating considerations of care coordination into the
attribution methodology. We believe that a clinician participating as
an individual who bills one E&M claim within a TIN that has 30 percent
of the total E&Ms for that trigger inpatient stay does not necessarily
have limited influence on episode costs due to the nature of inpatient
care involving teams. In addition, we seek to incentivize clinicians to
engage in greater care coordination throughout a patient's trajectory.
The case minimum of 20 for acute inpatient medical condition episode-
based measures as finalized above ensures that clinicians are reliably
measured in providing care to beneficiaries with those specific
conditions. We note that the mean reliability for the measures meets or
exceeds the established 0.4 reliability threshold under this
attribution methodology for TINs and TIN/NPIs.
Comment: Some commenters expressed concern with our procedural
episode groups proposal to attribute episodes to each MIPS eligible
clinician who renders a trigger service as identified by HCPCS/CPT
procedure codes. One commenter suggested that a clinician should be
required to bill at least two service codes in order to be attributed a
procedural episode in order to increase the reliability of the measure.
One commenter recommended that a single clinician should not be solely
attributed the costs for a patient based on the provision of a trigger
service, but that the responsibility should be shared among all
clinicians who treated the patient during the episode. One commenter
stated that the same patient would be attributed twice if a two-stage
procedure were performed.
Response: We believe that in the case of a procedural episode, the
clinician who performs the service has a significant influence on the
costs of care that are part of the episode that follows the provision
of that service. These clinicians perform significant therapeutic and
diagnostic services, and the episode-based measures are intended to
limit costs to those which the clinician can affect, such as by
avoiding complications or better managing the patient during the
episode. In many cases, it would not be practical to require more than
a single service, such as in cases of surgical services which may
encompass much of the period of the episode.
After consideration of the public comments, we are finalizing as
proposed our proposal at Sec. 414.1350(b)(6) for acute inpatient
medical condition episode groups specified beginning in the 2019
performance period, to attribute episodes to each MIPS eligible
clinician who bills inpatient evaluation and management (E&M) claim
lines during a trigger inpatient hospitalization under a TIN that
renders at least 30 percent of the inpatient E&M claim lines in that
hospitalization. Additionally, we also finalizing as proposed our
proposal at Sec. 414.1350(b)(7) for procedural episode groups
specified beginning in the 2019 MIPS performance period, to attribute
episodes to each MIPS eligible clinician who renders a trigger service
as identified by HCPCS/CPT procedure codes.
(4) Improvement Activities Performance Category
(a) Background
In CY 2017 Quality Payment Program final rule (81 FR 77179 through
77180), we codified at Sec. 414.1355 that the improvement activities
performance category would account for 15 percent of the final score.
We refer readers to section III.I.3.i.(1)(e) of this final rule where
we proposed to modify Sec. 414.1355 to provide further technical
clarifications. In addition, in the CY 2018 Quality Payment Program
final

[[Page 59777]]

rule (82 FR 53649), we codified at Sec. 414.1380(b)(3)(iv) that the
term recognized be accepted as equivalent to the term certified when
referring to the requirements for a patient-centered medical home to
receive full credit for the improvement activities performance category
for MIPS. We also finalized at Sec. 414.1380(b)(3)(x) that for the
2020 MIPS payment year and future years, to receive full credit as a
certified or recognized patient-centered medical home or comparable
specialty practice, at least 50 percent of the practice sites within
the TIN must be recognized as a patient-centered medical home or
comparable specialty practice (82 FR 53655). We refer readers to
section III.I.3.i.(1)(e)(i)(D) of this final rule for details on our
proposals regarding patient-centered medical homes.
In the CY 2017 Quality Payment Program final rule (81 FR 77539), we
codified the definition of improvement activities at Sec. 414.1305 to
mean an activity that relevant MIPS eligible clinicians, organizations,
and other relevant stakeholders identify as improving clinical practice
or care delivery and that the Secretary determines, when effectively
executed, is likely to result in improved outcomes. Further, in that
final rule (81 FR 77190), we codified at Sec. 414.1365 that the
improvement activities performance category would include the
subcategories of activities provided at section 1848(q)(2)(B)(iii) of
the Act. We also codified subcategories for improvement activities at
Sec. 414.1365 (81 FR 77190).
We also previously codified in the CY 2017 and CY 2018 Quality
Payment Program final rules (81 FR 77180 and 82 FR 53651, respectively)
data submission criteria for the improvement activities performance
category at Sec. 414.1360(a)(1). In addition, we established
exceptions for: Small practices; practices located in rural areas;
practices located in geographic HPSAs; non-patient facing individual
MIPS eligible clinicians or groups; and individual MIPS eligible
clinicians and groups that participate in a MIPS APM or a patient-
centered medical home submitting in MIPS (81 FR 77185, 77188).
Specifically, we codified at Sec. 414.1380(b)(3)(vii) that non-patient
facing MIPS eligible clinicians and groups, small practices, and
practices located in rural areas and geographic HPSAs receive full
credit for the improvement activities performance category by selecting
one high-weighted improvement activity or two medium-weighted
improvement activities; such practices receive half credit for the
improvement activities performance category by selecting one medium-
weighted improvement activity (81 FR 77185). We refer readers to
section III.I.3.i.(1)(e)(i)(B) of this final rule for our proposals
related to that provision. In addition, we specified at Sec. 414.1305
that rural areas refers to ZIP codes designated as rural, using the
most recent HRSA Area Health Resource File data set available (81 FR
77188, 82 FR 53582). Lastly, we finalized the meaning of Health
Professional Shortage Areas (HPSA) at Sec. 414.1305 to mean areas as
designated under section 332(a)(1)(A) of the Public Health Service Act
(81 FR 77188). In the CY 2018 Quality Payment Program final rule (82 FR
53581), we modified the definition of small practices at Sec. 414.1305
to mean practices consisting of 15 or fewer eligible clinicians.
In the CY 2019 PFS proposed rule (83 FR 35906 through 35912), we
requested comments on our proposals to: (1) Revise Sec. 414.1360(a)(1)
to more accurately describe the data submission criteria; (2) delete
Sec. 414.1365 and move improvement activities subcategories to Sec.
414.1355(c); (3) update the criteria considered for nominating new
improvement activities; (4) modify the Annual Call for Activities
timeline for the CY 2019 performance period and future years; (5) add 6
new improvement activities for the CY 2019 performance period and
future years; (6) modify 5 existing improvement activities for the CY
2019 performance period and future years; and (7) remove 1 existing
improvement activity for the CY 2019 performance period and future
years. In addition, we also requested comments on our proposals with
respect to the CMS Study on Factors Associated with Reporting Quality
Measures for the CY 2019 performance period and future years the
following proposals: (1) Change the title of the study to CMS Study on
Factors Associated with Reporting Quality Measures; (2) increase the
sample size to a minimum of 200 participants; (3) limit the focus group
requirement to a subset of the 200 participants; and (4) require that
at least one of the minimum of three required measures be a high
priority measure. We are also making clarifications to: (1)
Considerations for selecting improvement activities for the CY 2019
performance period and future years; and (2) the weighting of
improvement activities.
These topics are discussed in more detail below.
(b) Submission Criteria
We refer readers to the CY 2017 Quality Payment Program final rule
(81 FR 77181) for submission mechanism policies we finalized and
codified for the transition year of MIPS. In the CY 2018 Quality
Payment Program final rule (82 FR 53651), we continued these policies
for future years. Specifically, we finalized that for MIPS Year 2 and
future years, MIPS eligible clinicians or groups must submit data on
MIPS improvement activities in one of the following manners: Qualified
registries; EHR submission mechanisms; QCDR; CMS Web Interface; or
attestation. Additionally, we finalized that for activities that are
performed for at least a continuous 90-days during the performance
period, MIPS eligible clinicians must submit a yes response for
activities within the improvement activities inventory. In addition, in
the case where an individual MIPS eligible clinician or group is using
a health IT vendor, QCDR, or qualified registry for their data
submission, we finalized that the MIPS eligible clinician or group must
certify all improvement activities were performed and the health IT
vendor, QCDR, or qualified registry would submit on their behalf (82 FR
53650 through 53651). We also updated Sec. 414.1360 to reflect those
changes (82 FR 53651). We refer readers to section III.I.3.h.(1) of
this final rule, MIPS Performance Category Measures and Activities,
where we discuss our finalized policies to update the data submission
process for MIPS eligible clinicians, groups and third party
intermediaries, by updating our terminology. We also refer readers to
changes to Sec. 414.1325 for data submission requirements. In the CY
2019 PFS proposed rule (83 FR 35906), we proposed those changes to more
closely align with the actual submission experience users have.
In alignment with those proposals, we also proposed to revise Sec.
414.1360(a)(1) to more accurately reflect the data submission process
for the improvement activities performance category. In particular, in
the CY 2019 PFS proposed rule (83 FR 35906), we proposed that instead
of ``via qualified registries; EHR submission mechanisms; QCDR, CMS Web
Interface; or attestation,'' as currently stated, we revised the first
sentence to state that data would be submitted ``via direct, login and
upload, and login and attest'' as discussed in section III.I.3.h.(1)(b)
of this final rule. In addition, we proposed to add further additions
to Sec. 414.1360(a)(1) to specify, submit a yes response for each
improvement activity that is performed for at least a continuous 90-day
period during the applicable performance period.
We did not receive any comments on these proposals. Therefore, we
are

[[Page 59778]]

finalizing our proposals, as proposed, to revise the first sentence of
Sec. 414.1360(a)(1) to state that data must be submitted via direct,
login and upload, and login and attest. In addition, we are finalizing
our proposal, as proposed, to update Sec. 414.1360(a)(1) to specify:
Submit a yes response for each improvement activity that is performed
for at least a continuous 90-day period during the applicable
performance period.
(c) Subcategories
In the CY 2017 Quality Payment Program final rule (81 FR 77190), we
finalized at Sec. 414.1365 that the improvement activities performance
category includes the subcategories of activities provided at section
1848(q)(2)(B)(iii) of the Act. It has since come to our attention that
it is unnecessary to have a separate regulation text included under
Sec. 414.1365 since the subcategories are not a component of the
scoring calculations. Therefore, in the CY 2019 PFS proposed rule (83
FR 35906 through 35907), we proposed to delete Sec. 414.1365 and move
the same improvement activities subcategories to Sec. 414.1355(c). We
reiterate that we did not propose any changes to the subcategories
themselves. These subcategories are:
Expanded practice access, such as same day appointments
for urgent needs and after-hours access to clinician advice.
Population management, such as monitoring health
conditions of individuals to provide timely health care interventions
or participation in a QCDR.
Care coordination, such as timely communication of test
results, timely exchange of clinical information to patients or other
clinicians, and use of remote monitoring or telehealth.
Beneficiary engagement, such as the establishment of care
plans for individuals with complex care needs, beneficiary self-
management assessment and training, and using shared decision making
mechanisms.
Patient safety and practice assessment, such as through
the use of clinical or surgical checklists and practice assessments
related to maintaining certification.
Participation in an APM.
Achieving health equity, such as for MIPS eligible
clinicians that achieve high quality for underserved populations,
including persons with behavioral health conditions, racial and ethnic
minorities, sexual and gender minorities, people with disabilities,
people living in rural areas, and people in geographic HPSAs.
Emergency preparedness and response, such as measuring
MIPS eligible clinician participation in the Medical Reserve Corps,
measuring registration in the Emergency System for Advance Registration
of Volunteer Health Professionals, measuring relevant reserve and
active duty uniformed services MIPS eligible clinician activities, and
measuring MIPS eligible clinician volunteer participation in domestic
or international humanitarian medical relief work.
Integrated behavioral and mental health, such as measuring
or evaluating such practices as: Co-location of behavioral health and
primary care services; shared/integrated behavioral health and primary
care records; cross training of MIPS eligible clinicians, and
integrating behavioral health with primary care to address substance
use disorders or other behavioral health conditions, as well as
integrating mental health with primary care.
The following is a summary of the public comments received on our
proposals and our responses:
Comment: One commenter supported the definition of achieving health
equity and underserved populations. The commenter recommended that we
explicitly include people with limited English in those groups.
Response: We will take this suggestion into consideration for the
future.
After consideration of the public comments received, we are
finalizing our proposal, as proposed, to delete Sec. 414.1365 and move
the same improvement activities subcategories to Sec. 414.1355(c).
(d) Improvement Activities Inventory
In the CY 2019 PFS proposed rule (83 FR 35907 through 35910), we
proposed to: (1) Adopt one new criterion and remove one existing
criterion for nominating new improvement activities beginning with the
CY 2019 performance period and future years; (2) modify the timeframe
for the Annual Call for Activities; (3) add 6 new improvement
activities for the CY 2019 performance period and future years; (4)
modify 5 existing improvement activities for the CY 2019 performance
period and future years; and (5) remove 1 existing improvement activity
for the CY 2019 performance period and future years. We are also making
clarifications to: (1) Considerations for selecting improvement
activities for the CY 2019 performance period and future years; and (2)
the weighting of improvement activities.
(i) Annual Call for Activities
In the CY 2017 Quality Payment Program final rule (81 FR 77190),
for the transition year of MIPS, we implemented the initial Improvement
Activities Inventory and took several steps to ensure it was inclusive
of activities in line with statutory and program requirements. For Year
2, we provided an informal process for submitting new improvement
activities or modifications for potential inclusion in the
comprehensive Improvement Activities Inventory for the Quality Payment
Program Year 2 and future years through subregulatory guidance (https:/
/www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-
Instruments/MMS/Downloads/Annual-Call-for-Measures-and-Activities-for-
MIPS_Overview-Factsheet.pdf). In the CY 2018 Quality Payment Program
final rule (82 FR 53656 through 53659), for Year 3 and future years, we
finalized a formal Annual Call for Activities process for adding
possible new activities or providing modifications to the current
activities in the Improvement Activities Inventory, including
information required to submit a nomination form similar to the one we
utilized for Year 2 (82 FR 53656 through 53659). It is important to
note that in order to submit a request for a new activity or a
modification to an existing improvement activity the stakeholder must
submit a nomination form available at www.qpp.cms.gov during the Annual
Call for Activities.
(A) Criteria for Nominating New Improvement Activities
In the CY 2019 PFS proposed rule (83 FR 35907 through 35908), we
proposed to add one new criterion and remove a previously adopted
criterion from the improvement activities nomination criteria. We also
clarified our considerations in selecting improvement activities.
(aa) Currently Adopted Criteria
In the CY 2017 Quality Payment Program final rule (81 FR 77190
through 77195), we discussed guidelines for the selection of
improvement activities. In the CY 2018 Quality Payment Program final
rule, we formalized the Annual Call for Activities process for Year 3
and future years and added additional criteria; stakeholders would
apply one or more of the below criteria when submitting nominations for
improvement activities (82 FR 53660):
Relevance to an existing improvement activities
subcategory (or a proposed new subcategory);

[[Page 59779]]

Importance of an activity toward achieving improved
beneficiary health outcome;
Importance of an activity that could lead to improvement
in practice to reduce health care disparities;
Aligned with patient-centered medical homes;
Focus on meaningful actions from the person and family's
point of view;
Support the patient's family or personal caregiver;
Activities that may be considered for an advancing care
information bonus;
Representative of activities that multiple individual MIPS
eligible clinicians or groups could perform (for example, primary care,
specialty care);
Feasible to implement, recognizing importance in
minimizing burden, especially for small practices, practices in rural
areas, or in areas designated as geographic HPSAs by HRSA;
Evidence supports that an activity has a high probability
of contributing to improved beneficiary health outcomes; or
CMS is able to validate the activity.
(bb) New Criteria
We believe it is important to place attention on public health
emergencies, such as the opioid epidemic, when considering improvement
activities for inclusion in the Inventory, because their inclusion
raises awareness for clinicians about the urgency of the situation and
to promote clinician adoption of best practices to combat those public
health emergencies. A list of the public health emergency declarations
is available at https://www.phe.gov/Preparedness/legal/Pages/
phedeclaration.aspx. Therefore, in the CY 2019 PFS proposed rule (83 FR
35907 through 35908), we proposed to adopt an additional criterion
entitled ``Include a public health emergency as determined by the
Secretary'' to the criteria for nominating new improvement activities
beginning with the CY 2019 performance period and future years. We
invited public comment on our proposal.
The following is a summary of the public comments received on our
proposals and our responses:
Comment: Many commenters supported the additional criterion for
nominating improvement activities to include public health emergencies,
noting that such activities are important for patient care and will
help raise clinician awareness and promote best practices related to
the medically appropriate, evidence-based, and safe use of opioids in
treating chronic and acute pain and the use of non-opioid pain
management treatment alternatives. One commenter stated this criteria
could help ensure patients receive the most appropriate pain and
substance use disorder treatments. Another commenter stated this
criteria could support efforts to mobilize health care resources to
assist those in need and aid providers in relief efforts.
Response: We appreciate the commenters' support.
Comment: One commenter requested clarification regarding whether a
public health emergency is required to be listed for an improvement
activity to be considered and whether the improvement activities will
be removed once the public health emergency has been resolved.
Response: A list of federal public health emergency declarations is
available at https://www.phe.gov/Preparedness/legal/Pages/
phedeclaration.aspx. Modifications to existing improvement activities
in the Improvement Activities Inventory, including whether an
improvement activity should be removed due to a change in a public
health emergency status, will be considered through the formal Annual
Call for Activities on a case-by-case basis.
Comment: A few commenters did not support the proposed addition of
the public health emergency criteria. One commenter stated there is a
need for adequate notice and tracking mechanisms and recommended that
improvement activities should progress through the formal review
process. Another commenter recommended a process outside the Annual
Call for Activities that enables clinicians to propose an activity for
immediate implementation during a public health emergency declaration
and that such activities remain optional and be granted full credit
even if the duration does not span at least 90 continuous days.
Response: We agree that there is a need for adequate notice in
order to allow clinicians time to prepare. To be clear, Improvement
Activities will continue to be proposed and adopted via rulemaking; we
are merely adding a new criteria such that public health emergencies
are considered when stakeholders nominate improvement activities and
while we select improvement activities for proposal and adoption into
the Inventory. We do not agree that we should create a separate process
outside of the Annual Call for Activities or that such activities
should remain optional and be granted full credit even if the duration
does not span at least 90 continuous days. In the CY 2017 Quality
Payment Program final rule (81 FR 77186), we specified at Sec.
414.1360 that MIPS eligible clinicians or groups must perform
improvement activities for at least 90 consecutive days during the
performance period for improvement activities performance category
credit.
Comment: One commenter suggested that there should be a bonus
associated with the submission of an improvement activity regarding a
public health emergency.
Response: We disagree as we do not believe the submission of an
improvement activity should get bonus points. We are not able to
provide bonus points for improvement activities at this time.
After consideration of the public comments received, we are
finalizing our proposal, as proposed to adopt an additional criterion
entitled ``Include a public health emergency as determined by the
Secretary'' to the criteria for nominating new improvement activities
beginning with the CY 2019 performance period and future years.
(cc) Removal of One Criteria
In the CY 2017 Quality Payment Program final rule (81 FR 77202
through 77209), we adopted a policy to award a bonus to the Promoting
Interoperability performance category score for MIPS eligible
clinicians who use CEHRT to complete certain activities in the
improvement activities performance category. We included a designation
column in the Improvement Activities Inventory at Table H in the
Appendix of the CY 2017 Quality Payment Program final rule (81 FR
77817) that indicated which activities qualified for the Promoting
Interoperability (formerly Advancing Care Information) bonus codified
at Sec. 414.1380(b)(4)(i)(D).
In the CY 2019 PFS proposed rule (83 FR 35982), under the Promoting
Interoperability performance category, we proposed a new approach for
scoring that moves away from the base, performance, and bonus score
methodology currently established. This new approach removes the
availability of a bonus score for attesting to completing one or more
specified improvement activities using CEHRT beginning with the CY 2019
performance period and future years. As a result, we do not believe the
criterion for selecting improvement activities for inclusion in the
program entitled ``Activities that may be considered for an advancing
care information bonus'' remains relevant. Therefore, we proposed to
remove the criterion for selecting improvement activities for inclusion
in the program entitled ``Activities that may be considered for an
advancing care information bonus''

[[Page 59780]]

beginning with the CY 2019 performance period and future years (83 FR
35908).
If our proposals to add one criterion and remove one criterion are
adopted as proposed, the new list of criteria for nominating new
improvement activities for the CY 2019 performance period and future
years would be as follows:
Relevance to an existing improvement activities
subcategory (or a proposed new subcategory);
Importance of an activity toward achieving improved
beneficiary health outcome;
Importance of an activity that could lead to improvement
in practice to reduce health care disparities;
Aligned with patient-centered medical homes;
Focus on meaningful actions from the person and family's
point of view;
Support the patient's family or personal caregiver;
Representative of activities that multiple individual MIPS
eligible clinicians or groups could perform (for example, primary care,
specialty care);
Feasible to implement, recognizing importance in
minimizing burden, especially for small practices, practices in rural
areas, or in areas designated as geographic HPSAs by HRSA;
Evidence supports that an activity has a high probability
of contributing to improved beneficiary health outcomes;
Include a public health emergency as determined by the
Secretary; or
CMS is able to validate the activity.
We did not receive any comments on our proposal. Therefore, we are
finalizing our proposal, as proposed, to remove the criterion entitled
``Activities that may be considered for an advancing care information
bonus'' beginning with the CY 2019 performance period and future years.
We note that this policy is being finalized in alignment with those in
section III.I.3.h.(5)(d)(ii) of this final rule.
(B) Considerations in Selecting Improvement Activities
As noted in the CY 2017 Quality Payment Program final rule, we
intend to use the criteria for nominating new improvement activities in
selecting improvement activities for inclusion in the program (82 FR
53659). However, we clarify here that those criteria are but one factor
in determining which improvement activities we ultimately propose. For
example, we also generally take into consideration other factors, such
as whether the nominated improvement activity uses publically available
products or techniques (that is, does not contain proprietary products
or information limiting an activity) or whether the nominated
improvement activity duplicates any currently adopted activity (83 FR
35908).
(C) Weighting of Improvement Activities
Given stakeholder feedback requesting additional transparency
regarding the weighting of improvement activities (82 FR 53657), in the
CY 2019 PFS proposed rule (83 FR 35908 through 35909), we summarized
considerations we have previously used to assign weights to improvement
activities included in the Improvement Activities Inventory (see
Appendix 2: Improvement Activities, Tables A and B). We also made a few
clarifications and solicited comment for future weighting
considerations. These topics are discussed in more detail below.
(aa) Summary of Past Considerations
In the CY 2017 Quality Payment Program final rule (81 FR 77191), we
explained that to define the criteria and establish weighting for each
activity, we engaged multiple stakeholder groups, including the Centers
for Disease Control and Prevention, Health Resources and Services
Administration, Office of the National Coordinator for Health
Information Technology, SAMHSA, Agency for Healthcare Research and
Quality, Food and Drug Administration, the Department of Veterans
Affairs, and several clinical specialty groups, small and rural
practices and non-patient facing clinicians. Activities were proposed
to be weighted as high based on the extent to which they align with
activities that support the patient-centered medical home, since that
is the standard under section 1848(q)(5)(C)(i) of the Act for achieving
the highest potential score for the improvement activities performance
category, as well as with our priorities for transforming clinical
practice (81 FR 77191). Activities that require performance of multiple
actions, such as participation in the Transforming Clinical Practice
Initiative (TCPI), participation in a MIPS eligible clinician's state
Medicaid program, or an activity identified as a public health priority
(such as emphasis on anticoagulation management or utilization of
prescription drug monitoring programs) were also proposed to be
weighted as high (81 FR 77191). We also stated that we believe that
high-weighting should be used for activities that directly address
areas with the greatest impact on beneficiary care, safety, health, and
well-being (81 FR 77194). In the past, we have given certain
improvement activities high-weighting due to the intensity of the
activity; for example, one improvement activity was changed to high-
weighting because it often involves travel and work under challenging
physical and clinical circumstances (81 FR 77194). Also, we note that
successful participation in the CMS Study on Factors Associated with
Reporting Quality Measures as discussed in section III.I.3.h.(4)(e) of
this final rule would result in full credit for the improvement
activities performance category of 40 points; if participants do not
meet the study guidelines, they will need to follow the current
improvement activities guidelines (81 FR 77197).
(bb) Clarifications
In this final rule, we are clarifying: (a) Our consideration of
giving high-weighting due to activity intensity; and (b) differences
between high- and medium-weighting.
(AA) High-Weighting Due to Activity Intensity
As stated previously, we have given certain improvement activities
high-weighting due to the intensity of the activity (81 FR 77194). To
elaborate, we believe that an activity that requires significant
investment of time and resources should be high-weighted. For example,
we finalized the CAHPS for MIPS survey as high-weighted (81 FR 77827),
because it requires a significant investment of time and resources. As
part of the requirements of this activity, MIPS eligible clinicians:
(1) Must register for the CAHPS for MIPS survey; (2) must select and
authorize a CMS-approved survey vendor to collect and report survey
data using the survey and specifications provided by us; and (3) are
responsible for vendor's costs to collect and report the survey (ranges
from approximately $4,000 to $7,000 depending on services requested).
In contrast, we believe medium-weighted improvement activities are
simpler to complete and require less time and resources as compared to
high-weighted improvement activities. For example, we finalized the
Cost Display for Laboratory and Radiographic Orders improvement
activity as medium-weighted (82 FR 54188), because the information
required to be used is readily available (https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/) at no
cost through the Medicare clinical laboratory fee schedule and can be
distributed in a variety of manners with very little investment (for
example, it may be displayed in the clinic, provided to patients
through hardcopies, or incorporated in the electronic health record).

[[Page 59781]]

(BB) High- Versus Medium-Weighting
We recognize that we did not previously explicitly state separate
considerations for medium-weighted activities. This is because an
improvement activity is only either high or medium-weighted. In this
final rule, we are clarifying that an improvement activity is by
default medium-weight unless it meets considerations for high-weighting
as discussed previously (83 FR 35909).
(cc) Request for Comments
We intend to more thoroughly revisit our improvement activity
weighting policies in next year's rulemaking. We invited public comment
on the need for additional transparency and guidance on the weighting
of improvement activities as we work to refine the Annual Call for
Activities process for future years. Furthermore, in light of the
finalized policy to remove bonus points for improvement activities that
may be applicable to the Promoting Interoperability performance
category as discussed in sections III.I.3.h.(4)(d)(i)(A)(cc) and
III.I.3.h.(5)(d)(ii), we recognize the need to continue incentives for
CEHRT. Therefore, for future consideration, we solicited comment on
potentially applying high-weighting for any improvement activity
employing CEHRT. We also invited public comment on any other additional
considerations for high- or medium-weighting.
Comment: One commenter supported more transparency regarding the
differences between high-weight and medium-weight activities and
encouraged continued education related to the improvement activities
performance category as new activities are added. Another commenter
recommended that improvement activities related to Continuing Medical
Education (CME) be weighted in a bifurcated manner with more
substantial CME's potentially counting as high-weighted.
Response: We will take these comments into consideration as we
develop future policy.
(D) Timeframe for the Annual Call for Activities
In the CY 2018 Quality Payment Program final rule (82 FR 53660), we
finalized that we would accept submissions for prospective improvement
activities and modifications to existing improvement activities at any
time during the performance period to be added to the Improvement
Activities Under Review (IAUR) list, for the applicable performance
period, which would be displayed on a CMS website following the close
of the Annual Call for Activities. In addition, we finalized that for
the Annual Call for Activities, only nominations and modifications
submitted by March 1st would be considered for inclusion in the IAUR
list and Improvement Activities Inventory for the performance period
occurring in the following calendar year (82 FR 53660). For example,
for the CY 2018 Annual Call for Activities, we received nominations for
new and modified improvement activities from February 1st through March
1st. Currently, an improvement activity nomination submitted during the
CY 2018 Annual Call for Activities would be vetted in CY 2018, and
after review, if accepted by CMS, would be proposed during the CY 2018
rulemaking cycle for possible implementation in the CY 2019 performance
period and future years.
However, the previously established timeline, which includes
prospective new and modified improvement activities submission period,
review, and publication of proposed improvement activities for
implementation in the next performance period, has become operationally
challenging. Based on our experience over the past 2 years, we have
found that processing and reviewing the volume of improvement
activities nominations requires more time than originally thought. In
addition, preparations and drafting for annual rulemaking begin around
the time of the close date for the current Annual Call for Activities
(that is, March 1st), leaving incorporation into the proposed rule
challenging. Therefore, in the CY 2019 PFS proposed rule, beginning
with the CY 2019 performance period, we proposed to: (1) Delay the year
for which nominations of prospective new and modified improvement
activities would apply; and (2) expand the submission timeframe/due
date for nominations (83 FR 35909).
Beginning with the CY 2019 performance period, we proposed to
change the performance year for which the nominations of prospective
new and modified improvement activities would apply, such that
improvement activities nominations received in a particular year will
be vetted and considered for the next year's rulemaking cycle for
possible implementation in a future year. This timeframe parallels the
Promoting Interoperability performance category Annual Call for EHR
Measures timeframe available at https://www.cms.gov/Regulations-and-
Guidance/Legislation/EHRIncentivePrograms/CallForMeasures.html. For
example, an improvement activity nomination submitted during the CY
2020 Annual Call for Activities would be vetted, and if accepted by
CMS, would be proposed during the CY 2021 rulemaking cycle for possible
implementation starting in CY 2022. We believe this change would give
us adequate time to thoroughly vet improvement activity nominations
prior to rulemaking (83 FR 35909).
Second, beginning with the CY 2019 performance period, we proposed
to change the submission timeframe for the Annual Call for Activities
from February 1st through March 1st to February 1st through June 30th,
providing approximately 4 additional months for stakeholders to submit
nominations. We believe this change would assist stakeholders by
providing additional time to submit improvement activities nominations.
Consistent with previous policy, nominations for prospective new and
modified improvement activities would be accepted during the Annual
Call for Activities time period only and would be included in the IAUR
displayed on a CMS website following the close of the Annual Call for
Activities (83 FR 35909).
The following is a summary of the public comments received on our
proposals and our responses:
Comment: Several commenters supported the proposed change to the
Annual Call for Activities timeframe citing that the modified timeline
provides a longer window during which to propose new improvement
activities, allows for more advance notice to implement new activities
that have been finalized, aligns the Annual Call for Activities with
the Annual Call for Measures, and reduces overall program complexity.
One commenter noted the new timeframe would ensure that the inventory
includes an appropriate number of measures that are meaningful to each
specialty, including non-physician Medicare clinicians, and that are
appropriate for the patient-centered health care team and have a
positive impact on patient care.
Response: We appreciate the commenters' support.
Comment: Several commenters did not support the proposed extension
of the timeframe for the Annual Call for Activities and recommended
that we maintain the current schedule because this would ensure the
improvement activities inventory include activities that are timely,
important, relevant, and meaningful to the evolving practice of
medicine and to public health. One commenter noted extending the
timeframe from submission to

[[Page 59782]]

implementation is a barrier to previously stated goals in aligning
improvement activities with the quality improvement cycle. Another
commenter noted the benefit of being able to modify or add measures
each year outweighs the need for additional submission time and that
improvement activities do not require the same reliability and validity
testing necessary for successful quality measures and that improvement
activities be considered annually informed by the quality improvement
cycle. One commenter stated the proposal would impede the ability of
groups to create activities that raise awareness of novel or pressing
issues and promote best practices in a timely manner. Another commenter
urged us to take a modified approach to its proposal in which the
timeframe to modify existing measures would be shorter than that for
new measures. One commenter stated that delaying consideration of
improvement activities until the following year's rule making does not
appropriately reward early adopters of activities and suggested that
early adopters of an improvement activity could be given credit.
Response: Although improvement activities do not have the same
testing requirements as quality measures, we believe that improvement
activities are equally important in facilitating clinical practice
improvement. As such, sufficient time is needed to thoroughly review
all submissions to ensure we maintain an inventory that is both
meaningful and robust. In addition, we cannot increase the submission
period without increasing our review period. It would not be
operationally feasible to do otherwise. We also do not believe that
there is a benefit to providing for a review period that does not allow
for an adequate time to thoroughly vet improvement activity nominations
prior to rulemaking. However, we will continue to monitor the timeline
to assess if there are any future improvements that can be made to more
quickly incorporate new improvement activities into the program when
feasibly possible. We disagree that the timeframe would impede the
promotion of best practices or awareness of improvement-related
activities or issues because stakeholders are not precluded from
referencing that a particular activity has been submitted for
consideration as part of the Annual Call for Activities to raise
awareness and promote best practices. We recognize that the proposed
extended timeframe does not align with the submission, review, and
implementation of quality measures as part of the Annual Call for
Measures; however, we note our proposal parallels our timeframe with
the Promoting Interoperability performance category Annual Call for EHR
Measures timeframe (we refer readers to section III.I.3.h.(5)(f) of
this final rule for more information) and achieves alignment between
those performance categories.
After consideration of the public comments received on our
proposal, we are finalizing our proposal, as proposed, to change the
performance year for which the nominations of prospective new and
modified improvement activities would apply, such that beginning with
the CY 2019 performance period, improvement activities nominations
received in a particular year will be vetted and considered for the
next year's rulemaking cycle for possible implementation in a future
year. In addition, we are finalizing our proposal, as proposed, to
change the submission timeframe for the Annual Call for Activities from
February 1st through March 1st to February 1st through June 30th,
providing approximately 4 additional months for stakeholders to submit
nominations beginning with the CY 2019 performance period.
(ii) New Improvement Activities and Modifications to and Removal of
Existing Improvement Activities
In the CY 2018 Quality Payment Program final rule (82 FR 53660), we
finalized that we would add new improvement activities to the
Improvement Activities Inventory through notice-and-comment rulemaking.
We referred readers to Table H in the Appendix of the CY 2017 Quality
Payment Program final rule (81 FR 77177 through 77199) and Table F and
G in the Appendix of the CY 2018 Quality Payment Program final rule (82
FR 54175 through 54229) for our previously finalized Improvement
Activities Inventory. In the CY 2019 PFS proposed rule (83 FR 36359
through 36368), for CY 2019 performance period and future years, we
proposed 6 new improvement activities; we also proposed to: (1) Modify
5 existing activities; and (2) remove 1 existing activity. We also
proposed changes to our CMS Study on Factors Associated with Reporting
Quality Measures in section III.I.3.h.(4)(e) of this final rule.
Comment: A few commenters supported the overall approach for the
improvement activities performance category because of its goal-
oriented and technology-neutral approach to compliance, stating that
this provides the flexibility needed for clinicians to select the most
effective approaches for their patients that could include connected
health technology innovations. One commenter supported the stability in
the improvement activities performance category and the transparent
process for adding improvement activities to the inventory.
Response: We appreciate the commenters' support.
A summary of the public comments received on specific improvement
activities proposals and our responses may be found in Tables A and B
of Appendix 2: Improvement Activities in this final rule.
(e) CMS Study on Factors Associated With Reporting Quality Measures
(i) Background
In the CY 2017 Quality Payment Program final rule (81 FR 77195), we
created the Study on Improvement Activities and Measurement. In CMS'
quest to create a culture of improvement using evidence based medicine
on a consistent basis, fully understanding the strengths and
limitations of the current processes is crucial to better understand
and improve these current processes. We proposed to conduct a study on
clinical improvement activities and measurement to examine clinical
quality workflows and data capture using a simpler approach to quality
measures (81 FR 77196). The lessons learned in this study on practice
improvement and measurement may influence changes to future MIPS data
submission requirements. The goals of the study are to see whether
there will be improved outcomes, reduced burden in reporting, and
enhancements in clinical care by selected MIPS eligible clinicians (81
FR 77196). This study shall inform us on the root causes of clinicians'
performance measure data collection and submission burdens, as well as
challenges that hinder accurate and timely quality measurement
activities. Our goals are to use high quality, low cost measures that
are meaningful, easy to understand, operable, reliable, and valid. As
discussed in the CY 2017 Quality Payment Program final rule (81 FR
77195) the CMS Study on Burden Associated with Quality Reporting goals
are to see whether there will be improved outcomes, reduced burden in
reporting, and enhancements in clinical care by selected MIPS eligible
clinicians desiring:
A more data driven approach to quality measurement.
Measure selection unconstrained by a CEHRT program or
system.
Improving data quality submitted to CMS.

[[Page 59783]]

Enabling CMS to get data more frequently and provide
feedback more often.
This study evolved into ``CMS Study on Burdens Associated with
Reporting Quality Measures'' in the CY 2018 Quality Payment Program
final rule (82 FR 53662).
This study is ongoing, participants are recruited on a yearly basis
for a minimum period of 3 years, and current participants can opt-in or
out when the study year ends (81 FR 77195). Successful participation in
the study would result in full credit for the improvement activities
performance category of 40 points; if participants do not meet the
study guidelines, they will need to follow the current improvement
activities requirements (81 FR 77197). To meet the study requirements,
study participants must partake in two web-based survey questionnaires,
submit data for at least three MIPS clinician quality measures to CMS
during the CY 2019 performance period, and be available for selection
and participation in at least one focus group meeting (82 FR 53662).
Although we did not propose any changes to the study purpose, aim,
eligibility, or credit, in the CY 2019 PFS proposed rule (83 FR 35910
through 35911), we proposed, for the CY 2019 performance period and
future years, changes to the: (1) Title of the study; (2) sample size
to allow enough statistical power for rigorous analysis within some
categories, (3) focus group and survey requirements; and (4) measure
requirements. These proposals are discussed in more detail below.
(ii) Title
In the CY 2019 PFS proposed rule (83 FR 35910), beginning with the
CY 2019 performance period, we proposed to change the title of the
study from ``CMS Study on Burdens Associated with Reporting Quality
Measures'' to ``CMS Study on Factors Associated with Reporting Quality
Measures'' to more accurately reflect the study's intent and purpose.
To assess the root causes of clinician burden associated with the
collection and submission of clinician quality measures for MIPS, as
depicted in CY 2017 Quality Payment Program final rule (81 FR 77195),
replacing ``Burden'' with ``Factors'' in the title will eliminate
possible response or recall bias that may occur with data collection.
Having ``burden'' in the study title may elicit the tendency of survey
participants reporting more on their perception of burden and
challenges, and/or suppressing other factors that are associated with
their quality measure data collection and submission, that may be
relevant to examining the root cause of burden.
The following is a summary of the public comments related to our
proposal and our response:
Comment: One commenter supported the title change stating that the
terminology changes will attract a more diverse group of study
participants and encourage clinician participants in the study who will
work to simplify measures and ensure that that measures bring maximum
value to CMS, clinicians, and beneficiaries.
Response: We appreciate the commenters' support.
After consideration of the comments, we are finalizing our
proposal, as proposed, to change the title of the study from ``CMS
Study on Burdens Associated with Reporting Quality Measures'' to ``CMS
Study on Factors Associated with Reporting Quality Measures'' beginning
with the CY 2019 performance period.
(iii) Sample Size
(A) Current Policy
In the CY 2017 Quality Payment Program final rule (81 FR 77196), we
initially finalized a sample size of 42 participants (comprising of
groups and individual MIPS eligible facilities). In the CY 2018 Quality
Payment Program final rule (82 FR 53661), we increased that number and
finalized a sample size of a minimum of 102 individual and group
participants for performance periods occurring in CY 2018 for the
following categories:
20 urban individuals or groups of <3 eligible clinicians--
(broken down into 10 individuals & 10 groups).
20 rural individuals or groups of <3 eligible clinicians--
(broken down into 10 individuals & 10 groups).
10 groups of 3-8 eligible clinicians.
10 groups of 8-20 eligible clinicians.
10 groups of 20-100 eligible clinicians.
10 groups of 100 or greater eligible clinicians.
6 groups of >20 eligible clinicians reporting as
individuals--(broken down into 3 urban & 3 rural).
6 specialty groups--(broken down into 3 reporting
individually & 3 reporting as a group).
Up to 10 non-MIPS eligible clinicians reporting as a group
or individual (any number of individuals and any group size).
(B) New Sample Size
In the CY 2019 PFS proposed rule (83 FR 35910 through 35911), we
proposed to again increase the sample size for the CY 2019 performance
period and future years from a minimum of 102 to a minimum of 200 MIPS
eligible clinicians, which will enable us to more rigorously analyze
the statistical difference between the burden and factors associated
within the categories listed above. This proposed increase in sample
size would provide the minimum sample needed to get a significant
result with adequate statistical power to determine whether there are
any statistically significant differences in quality measurement data
submission associated with: (1) The size of practice or facility; (2)
clinician specialty of practice; (3) region of practice; (4) individual
or group reporting; and (5) clinician quality measure type. This
rigorous statistical analysis is important, because it facilitates
tracing the root causes of measurement burdens and data submission
errors that may be associated with various sub-groups of clinician
practices using quantitative analytical methods. We believe that a
larger sample size would also account for any attrition (drop out of
study participants before the study ends). Therefore, we proposed that
the new sample size distribution would be:
40 urban individuals or groups of <3 eligible clinicians--
(broken down into 20 individuals & 20 groups).
40 rural individuals or groups of <3 eligible clinicians--
(broken down into 20 individuals & 20 groups).
20 groups of 3-8 eligible clinicians.
20 groups of 8-20 eligible clinicians.
20 groups of 20-100 eligible clinicians.
20 groups of 100 or greater eligible clinicians.
Up to 6 groups of >20 eligible clinicians reporting as
individuals--(broken down into 3 urban & 3 rural).
Up to 6 specialty groups--(broken down into 3 reporting
individually & 3 reporting as a group).
Up to 10 non-MIPS eligible clinicians reporting as a group
or individual (any number of individuals and any group size).
The following is a summary of the public comments related to our
proposals and our responses:
Comment: One commenter supported the continuation of the study to
gather data on clinical improvement activities and measurement to
examine clinical quality workflows and data and the proposal to
increase the sample size of the study, stating that this would be a
simpler approach and allow more clinicians to participate and increase
the ability to conduct rigorous statistical analysis with sufficient
power.

[[Page 59784]]

Response: We appreciate the commenter's support.
Comment: One commenter recommended that clinicians located in both
urban and rural health practitioner shortage areas and clinicians who
serve a high proportion of low-income patients and patients of color be
included as study participants.
Response: We have been recruiting participants from health
practitioner shortage areas, as well as areas with high proportion of
patients of color and minority groups.
Comment: One commenter requested that CMS assure the quality
reporting burden study includes a sample of clinicians with multiple
special status categories, such as Certified Registered Nurse
Anesthetists, citing there is likely a sufficient number of clinicians
that meet the CMS special status requirements in the six specialty
groups. The commenter also requested CMS ascertain the burden placed on
special status clinicians in outpatient and ASC facilities.
Response: We appreciate the commenter's recommendation. The study
welcomes all MIPS eligible clinicians, including Certified Registered
Nurse Anesthetists, and non-MIPS clinicians to apply. We hope to
further expand the scope of the study in the future.
After consideration of the comments received, we are finalizing our
proposal, as proposed, to increase the sample size for the CY 2019
performance period and future years from a minimum of 102 to a minimum
of 200 MIPS eligible clinicians.
(iv) Focus Group
(A) Current Policies
We previously finalized in the CY 2017 Quality Payment Program
final rule (81 FR 77195) that for the transition year of MIPS, study
participants were required to attend a monthly focus group to share
lessons learned in submitting quality data along with providing survey
feedback to monitor effectiveness. The focus group includes providing
visual displays of data, workflows, and best practices to share amongst
the participants to obtain feedback and make further improvements (81
FR 77196). The focus groups are used to learn from the practices about
how to be more agile as we test new ways of measure recording and
workflow (81 FR 77196). In the CY 2018 Quality Payment Program final
rule (82 FR 53662), for Year 2 and future years, we reduced that
requirement and finalized that study participants would be required to
complete at least two web-based survey questionnaire and attend up to 4
focus group sessions throughout the year, but certain study
participants would be able to attend less frequently. Each study
participant is required to complete a survey prior to submitting MIPS
data and another survey after submitting MIPS data (82 FR 53662). The
purpose of reducing focus group attendance and survey participation was
to ease requirements for MIPS eligible clinicians or group of
clinicians who may have nothing new to contribute, without compromising
the minimum sample needed for focus groups. For example, if a MIPS
eligible clinician submitted all 6 measures after collecting 90 days of
data and attended the first available focus group and/or survey, the
clinician may have nothing new or relevant to discuss with the research
team on subsequent focus groups and/or surveys.
(B) New Requirements for Focus Group and Survey Participation
Although we proposed in the section previously to increase the
sample size of the study to a minimum of 200 MIPS eligible clinicians,
we do not believe we need focus groups for the entirety of that
population. We believe that requiring focus groups for all proposed
minimum of 200 MIPS eligible clinicians would only result in bringing
the data to a saturation point, a situation whereby the same themes and
information are recurring, and no new insights are given by additional
sources of data from focus groups.
Instead, we believe that selecting a subset of clinicians,
purposively, to participate in focus groups would be a more appropriate
approach because that would allow us to understand the experience of
select clinicians without imposing undue burden on all. This study is
voluntary as clinicians nominate themselves to participate and we
select a cohort from among these volunteers. Therefore, in the CY 2019
PFS proposed rule (83 FR 35911), we proposed to make the focus group
participation a requirement only for a selected subset of the study
participants, using purposive sampling and random sampling methods,
beginning with the CY 2019 performance period and future years. Those
selected would be required to participate in at least one focus group
meeting and complete survey requirement, in addition to all the other
study requirements. As previously established, each study participant
is required to complete a survey prior to submitting MIPS data and
another survey after submitting MIPS data. This requirement would
continue to apply for each selected subset participating in a focus
group.
We did not receive any comments on our proposal. Therefore, we are
finalizing our proposals, as proposed, to make the focus group
participation a requirement only for a selected subset of the study
participants, using purposive sampling and random sampling methods,
beginning with the CY 2019 performance period and future years. Those
selected would be required to participate in at least one focus group
meeting and complete the survey requirements, in addition to all the
other study requirements (81 FR 77195).
(v) Measure Requirements
(A) Current Requirements
In the CY 2017 Quality Payment Program final rule (81 FR 77196), we
finalized that for CY 2017, MIPS eligible clinicians or groups
participating in the CMS Study would submit their data and workflows
for a minimum of three MIPS clinician quality measures that are
relevant and prioritized by their practice. One of the measures must be
an outcome measure, and one must be a patient experience measure (81 FR
77196). We also finalized that for future years, participating MIPS
eligible clinicians or groups would select three of the measures for
which they have baseline data from the 2017 performance period to
compare against later performance years. We note that participating
MIPS eligible clinicians could elect to report on more measures
originally as this would provide more options from which to select in
subsequent years for purposes of measuring improvement. In the CY 2018
Quality Payment Program final rule, we finalized for the Quality
Payment Program Year 2 and future years, that study participants could
submit all their quality measures data at once, as it is done in the
MIPS program, (qpp.cms.gov) (82 FR 53662).
(B) Measure Requirements
In the CY 2019 PFS proposed rule (83 FR 35911), we proposed to
continue the previously required minimum number of measures. That is,
for the CY 2019 performance period and future years: participants must
submit data and workflows for a minimum of three MIPS quality measures
for which they have baseline data. However, instead of requiring one
outcome measure and one patient experience measure as previously
finalized, we proposed that, for the CY 2019 performance period and
future years, at least one of the minimum of three measures must be a
high priority measure as defined at

[[Page 59785]]

Sec. 414.1305. As defined there and discussed in section III.I.3.h.(2)
of this final rule, a high priority measure means an outcome,
appropriate use, patient safety, efficiency, patient experience, care
coordination, or opioid-related quality measure. Outcome measures
includes intermediate-outcome and patient-reported outcome measures. We
believe that focusing on high priority measures, rather than patient
experience measures, is important at this time, because it better
aligns with the MIPS quality measures data submission criteria. We
invited public comment on our proposal.
We did not receive any comments on our proposal. Therefore, we are
finalizing our proposal, as proposed, that for the CY 2019 performance
period and future years, at least one of the minimum of three measures
must be a high priority measure as defined at Sec. 414.1305.
We note that although the aforementioned activities (that is, the
CMS Study on Factors Associated with Reporting Quality Measures)
constitute an information collection request as defined in the
implementing regulations of the Paperwork Reduction Act of 1995 (5 CFR
part 1320), the associated burden is exempt from application of the
Paperwork Reduction Act. Specifically, section 1848(s)(7) of the Act,
as added by section 102 of MACRA (Pub. L. 114-10) states that Chapter
35 of title 44, United States Code, shall not apply to the collection
of information for the development of quality measures.
(5) Promoting Interoperability (PI) (Previously Known as the Advancing
Care Information Performance Category)
(a) Background
Section 1848(q)(2)(A) of the Act includes the meaningful use of
CEHRT as a performance category under the MIPS. In prior rulemaking, we
referred to this performance category as the advancing care information
performance category, and it is reported by MIPS eligible clinicians as
part of the overall MIPS program. As required by sections 1848(q)(2)
and (5) of the Act, the four performance categories of the MIPS shall
be used in determining the MIPS final score for each MIPS eligible
clinician. In general, MIPS eligible clinicians will be evaluated under
all four of the MIPS performance categories, including the advancing
care information performance category.
(b) Renaming the Advancing Care Information Performance Category
In this final rule, we are adopting several scoring and measurement
policies that will bring the performance category to a new phase of EHR
measurement with an increased focus on interoperability and improving
patient access to health information. To better reflect this focus, we
renamed the advancing care information performance category to the
Promoting Interoperability (PI) performance category. We believe this
change will help highlight the enhanced goals of this performance
category. We are finalizing revisions to the regulation text under 42
CFR part 414, subpart O, to reflect the new name.
(c) Certification Requirements Beginning in 2019
Under the definition of CEHRT under Sec. 414.1305, for the
performance periods in 2017 and 2018, MIPS eligible clinicians had
flexibility to use EHR technology certified to either the 2014 or 2015
Edition certification criteria, or a combination of the two Editions,
to meet the objectives and measures specified for the Promoting
Interoperability performance category (82 FR 53671 through 53672). As
we finalized previously (82 FR 53671-53672) beginning with the
performance period in 2019, MIPS eligible clinicians must use EHR
technology certified to the 2015 Edition certification criteria as
specified at Sec. 414.1305. We believe it is appropriate to require
the use of 2015 Edition CEHRT beginning in CY 2019. In reviewing the
state of health information technology, it is clear the 2014 Edition
certification criterion are out of date and insufficient for clinician
needs in the evolving health information technology (IT) industry. It
will be beneficial to health IT developers and health care providers to
move to more up-to-date standards and functions that better support
interoperable exchange of health information and improve clinical
workflows.
We received many comments regarding the requirement to use the 2015
Edition of CEHRT beginning in 2019. As we stated in the CY 2019 PFS
proposed rule (83 FR 35912 through 35913), we did not propose to change
the requirement. Because the requirement was not a subject of this
rulemaking, we are not responding to the comments we received, although
we may consider them to inform our future policy making in this subject
area.
(d) Scoring Methodology
(i) Scoring Methodology for 2017 and 2018 Performance Periods
Section 1848(q)(5)(E)(i)(IV) of the Act states that 25 percent of
the MIPS final score shall be based on performance for the Promoting
Interoperability performance category. Accordingly, under Sec.
414.1375(a), the Promoting Interoperability performance category
comprises 25 percent of a MIPS eligible clinician's final score for the
2019 MIPS payment year and each MIPS payment year thereafter, unless we
assign a different scoring weight. We proposed to revise Sec.
414.1375(a) (83 FR 35913) to specify the various sections of the
statute (sections 1848(o)(2)(D), 1848(q)(5)(E)(ii), and 1848(q)(5)(F)
of the Act) under which a different scoring weight may be assigned for
the Promoting Interoperability performance category. We established the
reporting criteria to earn a performance category score for the
Promoting Interoperability performance category under Sec.
414.1375(b). We proposed to revise Sec. 414.1375(b)(2)(i) to replace
the reference to ``each required measure'' with ``each base score
measure'' to improve the precision of the text. Under Sec.
414.1380(b)(4), the Promoting Interoperability performance category
score is comprised of a score for participation and reporting, known as
the ``base score,'' and a score for performance at varying levels above
the base score requirements, known as the ``performance score,'' as
well as any applicable bonus scores. We proposed several editorial
changes to Sec. 414.1380(b)(4) in an effort to more clearly and
concisely capture the previously established policies. For further
explanation of our scoring policies for performance periods in 2017 and
2018 for the Promoting Interoperability performance category, we refer
readers to 81 FR 77216 through 77227 and 82 FR 53663 through 53664.
A general summary overview of the scoring methodology for the
performance period in 2018 is provided in the Table 38.

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We did not receive any comments on the proposed revisions to the
regulation text at Sec. Sec. 414.1375(a) and (b)(2)(i), and Sec.
414.1380(b)(4). We are finalizing these revisions as proposed.
We heard from many stakeholders that the current scoring
methodology is complicated and difficult to understand. By providing
flexibility and offering clinicians multiple measures to choose from
within the performance score, it appears some clinicians may have been
confused by the options. Other MIPS eligible clinicians have indicated
that they dislike the base score because it is a required set of
measures and provides no flexibility because the scoring is all or
nothing. If a MIPS eligible clinician cannot fulfill the base score,
they cannot

[[Page 59787]]

earn a performance and/or bonus score. We have also received feedback
from clinicians and specialty societies that the current requirements
detract from their ability to provide care to their patients. In
addition, stakeholders have indicated that the requirements of the
Promoting Interoperability performance category for clinicians do not
align with the requirements of the Medicare Promoting Interoperability
Program for eligible hospitals and critical access hospitals (CAHs) and
that this creates a burden for the medical staff who are tasked with
overseeing the participation of both clinicians and hospitals in these
programs.
Based on the concerns expressed by stakeholders, we proposed a new
scoring methodology (83 FR 35913-395918) and moved away from the base,
performance and bonus score methodology that we currently use. We
stated our belief that this change would provide a simpler, more
flexible, less burdensome structure, allowing MIPS eligible clinicians
to put their focus back on patients. The introduction of this new
scoring methodology would continue to encourage MIPS eligible
clinicians to push themselves on measures that are most applicable to
how they deliver care to patients, instead of focusing on measures that
may not be as applicable to them. Our goal was to provide increased
flexibility to MIPS eligible clinicians and enable them to focus more
on patient care and health data exchange through interoperability.
Additionally, we wanted to align the requirements of the Promoting
Interoperability performance category with the requirements of the
Medicare Promoting Interoperability Program for eligible hospitals and
CAHs as we had proposed in the FY 2019 IPPS/LTCH PPS proposed rule (83
FR 20515 through 20537). As the distinction between ambulatory and
inpatient CEHRT has diminished and more clinicians are sharing
hospitals' CEHRT, we stated our belief that aligning the requirements
between programs would lessen the burden on health care providers and
facilitate their participation in both programs.
(ii) Proposed Scoring Methodology Beginning With the MIPS Performance
Period in 2019
In the CY 2019 PFS proposed rule (83 FR 35914 through 35918), we
proposed a new scoring methodology, beginning with the performance
period in 2019, to include a combination of new measures, as well as
the existing Promoting Interoperability performance category measures,
broken into a smaller set of four objectives and scored based on
performance. We stated our belief that this would be an overhaul of the
existing program requirements as it would eliminate the concept of base
and performance scores. We proposed a smaller set of objectives that
consisted of e-Prescribing, Health Information Exchange, Provider to
Patient Exchange, and Public Health and Clinical Data Exchange. We
proposed these objectives to promote specific HHS priorities and
satisfy the requirements of section 1848(o)(2) of the Act. We included
the e-Prescribing and Health Information Exchange objectives in part to
capture what we believe are core goals for the 2015 Edition of CEHRT
and also to satisfy the statutory requirements. These core goals
promote interoperability between health care providers and health IT
systems to support safer, more coordinated care. The Provider to
Patient Exchange objective promotes patient awareness and involvement
in their health care through the use of APIs, and ensures patients have
access to their medical data. Finally, the Public Health and Clinical
Data Exchange objective supports the ongoing systematic collection,
analysis, and interpretation of data that may be used in the prevention
and controlling of disease through the estimation of health status and
behavior. The integration of health IT systems into the national
network of health data tracking and promotion improves the efficiency,
timeliness, and effectiveness of public health surveillance. We stated
our belief that it is important to keep these core goals, primarily
because these objectives promote interoperability between health care
providers and health IT systems to support safer, more coordinated care
while ensuring patients have access to their medical data.
Under the proposed scoring methodology, MIPS eligible clinicians
would be required to report certain measures from each of the four
objectives, with performance-based scoring occurring at the individual
measure-level. Each measure would be scored based on the MIPS eligible
clinician's performance for that measure, based on the submission of a
numerator and denominator, except for the measures associated with the
Public Health and Clinical Data Exchange objective, which require ``yes
or no'' submissions. Each measure would contribute to the MIPS eligible
clinician's total Promoting Interoperability performance category
score. The scores for each of the individual measures would be added
together to calculate the Promoting Interoperability performance
category score of up to 100 possible points for each MIPS eligible
clinician. In general, the Promoting Interoperability performance
category score makes up 25 percent of the MIPS final score. If a MIPS
eligible clinician fails to report on a required measure or claim an
exclusion for a required measure if applicable, the clinician would
receive a total score of zero for the Promoting Interoperability
performance category.
We also considered an alternative approach in which scoring would
occur at the objective level, instead of the individual measure level,
and MIPS eligible clinicians would be required to report on only one
measure from each objective to earn a score for that objective. Under
this scoring methodology, instead of six required measures, the MIPS
eligible clinician total Promoting Interoperability performance
category score would be based on only four measures, one measure from
each objective. Each objective would be weighted similarly to how the
objectives are weighted in our proposed methodology, and bonus points
would be awarded for reporting any additional measures beyond the
required four. We solicited public comment on this alternative
approach, and whether additional flexibilities should be considered,
such as allowing MIPS eligible clinicians to select which measures to
report on within an objective and how those objectives should be
weighted, as well as whether additional scoring approaches or
methodologies should be considered.
In our proposed scoring methodology, the e-Prescribing objective
would contain three measures each weighted differently to reflect their
potential availability and applicability to the clinician community. In
addition to the existing e-Prescribing measure, we proposed to add two
new measures to the e-Prescribing objective: Query of Prescription Drug
Monitoring Program (PDMP); and Verify Opioid Treatment Agreement. For
more information about these two proposed measures, we refer readers to
section III.H.3.h.(5)(f) of the proposed rule (83 FR 35922 through
35925). The e-Prescribing measure would be required for reporting and
weighted at 10 points because we believed it would be applicable to
most MIPS eligible clinicians. In the event that a MIPS eligible
clinician meets the criteria and claims the exclusion for the e-
Prescribing measure in 2019, the 10 points available for that measure
would be redistributed equally among the two measures under the Health
Information Exchange objective:

[[Page 59788]]

Support Electronic Referral Loops By Sending Health
Information Measure (25 points).
Support Electronic Referral Loops By Receiving and
Incorporating Health Information (25 points).
We solicited public comment on whether this redistribution is
appropriate for 2019, or whether the points should be distributed
differently.
The Query of PDMP and Verify Opioid Treatment Agreement measures
would be optional for the MIPS performance period in 2019. These new
measures may not be available to all MIPS eligible clinicians for the
MIPS performance period in 2019 as they may not have been fully
developed by their health IT vendor, or not fully implemented in time
for data capture and reporting. Therefore, we did not propose to
require these two new measures in 2019, although MIPS eligible
clinicians may choose to report them and earn up to 5 bonus points for
each measure. We proposed to require these measures beginning with the
MIPS performance period in 2020, and we solicited public comment on
this proposal.
Due to varying state requirements, not all MIPS eligible clinicians
would be able to e-prescribe controlled substances, and thus, these
measures would not be available to them. For these reasons, in the CY
2019 PFS proposed rule (83 FR 35915 through 35916) we proposed an
exclusion for these two measures beginning with the MIPS performance
period in 2020. The exclusion would provide that any MIPS eligible
clinician who is unable to report the measure in accordance with
applicable law would be excluded from reporting the measure, and the 5
points assigned to that measure would be redistributed to the e-
Prescribing measure.
As the two new opioid measures become more broadly available in
CEHRT, we proposed each of the three measures within the e-Prescribing
objective would be worth 5 points beginning with the MIPS performance
period in 2020. Requiring these two measures would add 10 points to the
maximum total score for the Promoting Interoperability performance
category as these measures would no longer be eligible for optional
bonus points. To maintain a maximum total score of 100 points,
beginning with the MIPS performance period in 2020, we proposed to
reweight the e-Prescribing measure from 10 points down to 5 points, and
reweight the Provide Patients Electronic Access to Their Health
Information measure from 40 points down to 35 points as illustrated in
Table 38. We proposed that if the MIPS eligible clinician qualifies for
the e-Prescribing exclusion and is excluded from reporting all three of
the measures associated with the e-Prescribing objective as described
in section III.H.3.h.(5)(f) of the proposed rule, (83 FR 35921) the 15
points for the e-Prescribing objective would be redistributed evenly
among the two measures associated with the Health Information Exchange
objective and the Provide Patients Electronic Access to their Health
Information measure by adding 5 points to each measure.
We refer readers to section III.I.3.h.(5)(f) of this final rule,
where we discuss the Promoting Interoperability performance category
measures, for a discussion of the comments we received regarding the
above-referenced proposed scoring methodology for the e-Prescribing
objective and associated measures. After consideration of the public
comments we received, we are finalizing our proposed scoring for the E-
Prescribing objective as proposed but with the modifications discussed
at the end of this section III.I.3.h.(5)(f) of the preamble of this
final rule. The e-Prescribing measure is finalized with modification,
the Query of PDMP measure is finalized with modification, and the
Verify Opioid Treatment Agreement measure is finalized with
modification. In addition, we refer readers to section
III.I.3.h.(5)(f)(ii) of the preamble of this final rule where we
discuss our reasons for adopting the Query of PDMP measure with
modification and the Verify Opioid Treatment Agreement measure with
modification.
For the Health Information Exchange objective, we proposed to
change the name of the existing Send a Summary of Care measure to
Support Electronic Referral Loops by Sending Health Information
measure, and proposed a new measure which combines the functionality of
the existing Request/Accept Summary of Care and Clinical Information
Reconciliation measures into a new measure, Support Electronic Referral
Loops by Receiving and Incorporating Health Information measure. For
more information about the proposed measure and measure changes, we
refer readers to section III.I.3.h.(5)(f) of the proposed final rule
(83 FR 35925 through 35928). MIPS eligible clinicians would be required
to report both of these measures, each worth 20 points toward their
total Promoting Interoperability performance category score. These
measures are weighted heavily to emphasize the importance of sharing
health information through interoperable exchange in an effort to
promote care coordination and better patient outcomes. Similar to the
two new measures in the e-Prescribing objective, the new Support
Electronic Referral Loops by Receiving and Incorporating Health
Information measure may not be available to all MIPS eligible
clinicians as it may not have been fully developed by their health IT
vendor, or not fully implemented in time for a MIPS performance period
in 2019. For these reasons, we proposed two exclusions for the Support
Electronic Referral Loops by Receiving and Incorporating Health
Information measure:
1. Any MIPS eligible clinician who is unable to implement the
measure for a MIPS performance period in 2019 would be excluded from
this measure.
2. Any MIPS eligible clinician who receives fewer than 100
transitions of care or referrals or has fewer than 100 encounters with
patients never before encountered during the performance period would
be excluded from this measure.
We note that these two exclusions for the measure were proposed in
different sections of the proposed rule (83 FR 35916, 35927).
In the event that a MIPS eligible clinician claims an exclusion for
the Support Electronic Referral Loops by Receiving and Incorporating
Health Information measure, the 20 points would be redistributed to the
Support Electronic Referral Loops by Sending Health Information
measure, and that measure would then be worth 40 points. We solicited
public comment on whether this redistribution is appropriate, or
whether the points should be redistributed to other measures instead.
We refer readers to section III.I.3.h.(5)(f) of this final rule,
where we discuss the Promoting Interoperability performance category
measures, for a discussion of the comments we received regarding the
above-referenced proposed scoring methodology for the Health
Information Exchange objective and associated measures. We did not
receive any comments regarding the redistribution of points if an
exclusion is claimed for the Support Electronic Referral Loops by
Receiving and Incorporating Health Information measure. After
consideration of the comments that we received, we are finalizing our
proposals for the Health Information Exchange objective as proposed. In
addition, measure specification details can be found in section
III.I.3.h.(5)(f) of the preamble of this final rule.
In the CY 2019 PFS proposed rule (83 FR 359186), we proposed to
weight the

[[Page 59789]]

one measure in the Provider to Patient Exchange objective, Provide
Patients Electronic Access to Their Health Information, at 40 points
toward the total Promoting Interoperability performance category score
in 2019 and 35 points beginning in 2020. We proposed that this measure
would be weighted at 35 points beginning in 2020 to account for the two
new opioid measures, which would be worth 5 points each beginning in
2020 as proposed. We stated our belief that this objective and its
associated measure get to the core of improved access and exchange of
patient data in Promoting Interoperability and are the crux of the
Promoting Interoperability performance category. This exchange of data
between health care provider and patient is imperative in order to
continue to improve interoperability, data exchange and improved health
outcomes. We stated that it is important for patients to have control
over their own health information, and through this highly weighted
objective we are aiming to show our dedication to this effort.
We solicited comment on these proposals and our summary and
response are below.
Comment: A few commenters supported CMS' proposed weighting of the
Provide Patients Electronic Access to Their Health Information measure.
Response: We appreciate the support regarding the proposed weight
of this measure. We believe that it is important to give patients
access to their data and therefore the measure deserves to be highly
weighted.
Comment: A few commenters stated that an allocation of 40 points to
a single measure (Provide Patient Electronic Access to Their Health
Information) is too high. Commenters stated that if the points are
redistributed to other measures because exclusions are claimed,
especially if an exclusion is claimed on more than one measure, the
emphasis on the remaining measures will increase.
Response: We believe that it is essential for patients to have
access to their health information and the assignment of 40 points to
this measure reflects the importance we place on patient's access to
their health information.
After consideration of the comments, we are finalizing with
modification the proposals for the Provider to Patient Exchange
objective. The Provide Patients Electronic Access to Their Health
Information measure will be worth up to 40 points beginning in CY 2019.
We had proposed that the measure would be worth up to 35 points
beginning in CY 2020, but we are not finalizing that proposal because
we are not requiring the Verify Opioid Treatment Agreement measure
beginning in CY 2020 as proposed, which would have been worth up to 5
points. For additional measure information, we refer readers to section
III.I.3.h.(5)(f) of the preamble of this final rule.
The measures under the Public Health and Clinical Data Exchange
objective are reported using ``yes or no'' responses and thus we
proposed to score those measures on a pass/fail basis in which the MIPS
eligible clinician would receive the full 10 points for reporting two
``yes'' responses, or for submitting a ``yes'' for one measure and
claiming an exclusion for another. If there are no ``yes'' responses
and two exclusions are claimed, the 10 points would be redistributed to
the Provide Patients Electronic Access to Their Health Information
measure. A MIPS eligible clinician would receive zero points for
reporting ``no'' responses for the measures in this objective if they
do not submit a ``yes'' or claim an exclusion for at least two measures
under this objective. We proposed that for this objective, the MIPS
eligible clinician would be required to report on two measures of their
choice from the following list of measures: Immunization Registry
Reporting, Electronic Case Reporting, Public Health Registry Reporting,
Clinical Data Registry Reporting, and Syndromic Surveillance Reporting.
To account for the possibility that not all of the measures under the
Public Health and Clinical Data Exchange objective may be applicable to
all MIPS eligible clinicians, we proposed to establish exclusions for
these measures as described in section III.H.3.h.(5)(f) of the proposed
rule (83 FR 35929 through 35930). If a MIPS eligible clinician claims
two exclusions, the 10 points for this objective would be redistributed
to the Provide Patients Electronic Access to their Health Information
measure under the Provider to Patient Exchange objective, making that
measure worth 50 points in 2019 and 45 points beginning in 2020.
Reporting more than two measures for this objective would not earn the
MIPS eligible clinician any additional points. We refer readers to
section III.H.3.h.(5)(f) of the proposed rule (83 FR 35929 through
35930) in regard to the proposals for the Public Health and Clinical
Data Exchange objective and its associated measures.
We solicited comment on these proposals and our summary and
response are below.
Comment: A commenter suggested that MIPS eligible clinicians should
be eligible to earn more points for reporting on more than two public
health and clinical data exchange measures.
Response: We appreciate the suggestion but decline to implement it
at this time. We are limiting bonus point opportunities to brand new
measures, such as those associated with the e-Prescribing objective, in
an effort to maintain simplicity and avoid confusion in our scoring
methodology.
Comment: Some commenters questioned whether they could receive
credit for reporting to more than one registry for a measure.
Response: We believe that a clinician who is in active engagement
with two different public health agencies or clinical data registries
for purposes of the same measure would accomplish the same policy goal
as our proposal to report on two measures. It is also consistent with
the policy we established in the CY 2018 Quality Payment Program final
rule for reporting on the measures associated with the Public Health
and Clinical Data Registry Reporting Objective for the performance
score and bonus score (82 FR 53663-53664). In addition, allowing MIPS
eligible clinicians to report to two different public health agencies
or clinical data registries of their choice promotes flexibility in
reporting and allows them to focus on the public health measures that
are most relevant to them and their patient populations. Therefore, we
will be adopting our proposal with modification to allow clinicians the
flexibility to report to two different public health agencies or
clinical data registries for purposes of the same measure.
After consideration of the public comments we received, we are
finalizing our proposals for the Public Health and Clinical Data
Exchange objective with modifications. MIPS eligible clinicians must
report to two different public health agencies or clinical data
registries for any of the following measures: Syndromic Surveillance
Reporting, Immunization Registry Reporting, Electronic Case Reporting,
Public Health Registry Reporting, and Clinical Data Registry Reporting.
MIPS eligible clinicians may report to two different public health
agencies or clinical data registries for purposes of the same measure
if they choose. For additional measure information, we refer readers to
section III.I.3.h.(5)(f) of this final rule.
In the CY 2019 PFS proposed rule (83 FR 359186), we proposed that
the Protect Patient Health Information objective and its associated
measure, Security Risk Analysis, would remain part of the requirements
for the

[[Page 59790]]

Promoting Interoperability performance category, but would no longer be
scored as a measure and would not contribute to the MIPS eligible
clinician's Promoting Interoperability performance category score. To
earn any score in the Promoting Interoperability performance category,
we proposed a MIPS eligible clinician would have to report that they
completed the actions included in the Security Risk Analysis measure at
some point during the calendar year in which the performance period
occurs. We stated our belief that the Security Risk Analysis measure
involves critical tasks and noted that the HIPAA Security Rule requires
covered entities to conduct a risk assessment of their health care
organization. This risk assessment will help MIPS eligible clinicians
comply with HIPAA's administrative, physical, and technical safeguards.
Therefore, we stated that every MIPS eligible clinician should already
be meeting the requirements for this objective and measure as it is a
requirement of HIPAA. We indicated that we still believe this objective
and its associated measure are imperative in ensuring the safe delivery
of patient health data. As a result, we would maintain the Security
Risk Analysis measure as part of the Promoting Interoperability
performance category, but we would not score the measure.
The following is a summary of the public comments received on the
proposals for the Protect Patient Health Information objective and its
associated measure, Security Risk Analysis and our responses.
Comment: A commenter stated that the Security Risk Analysis measure
has historically been challenging for physicians. The commenter did not
support the annual reporting of this measure to be required to achieve
any score in the Promoting Interoperability category. To overcome what
the commenter described as the burdensome nature of this measure, the
commenter indicated that MIPS eligible clinicians need additional
support and resources to aid in their understanding of how to conduct a
security risk analysis that is compliant with CMS's standards.
Response: The Security Risk Analysis measure has been a required
measure since the beginning of the EHR Incentive programs in 2011
through the transition to MIPS starting in 2017. The requirement
remains that the actions included in the measure must be performed once
during the calendar year in which the performance period occurs. We
appreciate the commenter's interest in additional educational materials
for clinicians on how they can improve the privacy and security of
their health information. We refer them to https://www.cms.gov/
Regulations-and-Guidance/Legislation/EHRIncentivePrograms/Downloads/
2016_SecurityRiskAnalysis.pdf. HHS Office for Civil Rights (OCR) has
issued guidance on conducting a security risk analysis in accordance
with the HIPAA Security Rule (https://www.hhs.gov/hipaa/
forprofessionals/security/guidance/guidance-risk-analysis/).
Additional free tools and resources available to assist MIPS eligible
clinicians include a Security Risk Assessment (SRA) Tool developed by
the Office of National Coordinator for Health Information Technology
(ONC) and OCR at https://www.healthit.gov/providersprofessionals/
security-risk-assessment-tool. We believe that performing an annual
security risk assessment will help identify security weaknesses and may
provide opportunities to improve the security of the MIPS eligible
clinician's electronic systems.
Comment: Several commenters stated that if the Security Risk
Analysis measure is required, then MIPS eligible clinicians should
receive credit for doing it. The commenters recommended that the
technological, encryption, and other cybersecurity components of the
security risk analysis should be shifted to the health IT vendor and
should not be a burden placed on MIPS eligible clinicians.
Response: As we discussed in the proposed rule (83 FR 35916), we do
not believe that the Security Risk Analysis measure should be scored
because it includes actions already required under HIPAA and will help
MIPS eligible clinicians comply with HIPAA's administrative, physical,
and technical safeguards. We do not believe points should be awarded
because MIPS eligible clinicians should have already been performing
these actions. In addition, while a health IT vendor's products must
possess the relevant privacy and security capabilities be certified, we
believe that MIPS eligible clinicians must also conduct security risk
assessments to make sure that vulnerabilities are identified and
remediated. In addition, successful completion of a security risk
analysis is required to earn a score in the Promoting Interoperability
performance category.
Comment: The majority of commenters supported CMS' proposal to
require MIPS eligible clinicians to attest to the completion of the
actions of the Security Risk Analysis measure with no associated score
in order to be eligible to receive an overall score in the Promoting
Interoperability performance category. They stated that this measure is
essential to safely transmitting their patient data and successfully
participating in the Promoting Interoperability performance category.
Response: As discussed in the preceding response, we agree that
this measure should not be scored.
After consideration of the public comments, we are finalizing our
proposal to require MIPS eligible clinicians to attest that they
completed the actions included in the Security Risk Analysis measure at
some point during the calendar year in which the MIPS performance
period occurs. MIPS eligible clinicians who fail to complete these
actions or fail to attest will not earn any score for the Promoting
Interoperability performance category, regardless of whether they
report on other measures for this category.
As we proposed at 83 FR 35916, similar to how MIPS eligible
clinicians currently submit data, the MIPS eligible clinician would
submit their numerator and denominator data for each measure, and a
``yes or no'' response for each of the two reported measures under the
Public Health and Clinical Data Exchange objective. The numerator and
denominator for each measure would then translate to a performance rate
for that measure and would be applied to the total possible points for
that measure. For example, the e-Prescribing measure was proposed to be
worth 10 points. A numerator of 200 and denominator of 250 would yield
a performance rate of (200/250) = 80 percent. This 80 percent would be
applied to the 10 total points available for the e-Prescribing measure
to determine the measure score. A performance rate of 80 percent for
the e-Prescribing measure would equate to a measure score of 8 points
(performance rate * total possible measure points = points awarded
toward the total Promoting Interoperability performance category score;
80 percent * 10 = 8 points). To calculate the Promoting
Interoperability performance category score, the measure scores would
be added together, and the total sum would be divided by the total
possible points (100). The total sum cannot exceed the total possible
points. This calculation results in a fraction from zero to 1, which
can be formatted as a percent. For further clarification we refer
readers to the scoring example that we included in the proposed rule
(83 FR 35917).
When calculating the performance rates, measure and objective
scores, and the Promoting Interoperability performance category score,
we would generally round to the nearest whole

[[Page 59791]]

number. For example if a MIPS eligible clinician received a score of
8.53 the nearest whole number would be 9. Similarly, if the MIPS
eligible clinician received a score of 8.33 the nearest whole number
would be 8. In the event that the MIPS eligible clinician receives a
performance rate or measure score of less than 0.5, as long as the MIPS
eligible clinician reported on at least one patient for a given
measure, a score of 1 would be awarded for that measure. We stated that
we believed this is the best method for the issues that might arise
with the decimal points and is the easiest for computations.
In order to meet statutory requirements and HHS priorities, the
MIPS eligible clinician would need to report on all of the required
measures across all objectives in order to earn any score at all for
the Promoting Interoperability performance category. Failure to report
any required measure, or reporting a ``no'' response on a ``yes or no''
response measure, unless an exclusion applies would result in a score
of zero. We solicited public comment on the proposed requirement to
report on all required measures, or whether reporting on a smaller
subset of optional measures would be appropriate.

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In the proposed rule (83 FR 35917), we sought public comment on
whether these measures are weighted appropriately, or whether a
different weighting distribution, such as equal distribution across all
measures would be better suited to this program and this proposed
scoring methodology. We also sought public comment on other scoring
methodologies such as the alternative we considered and described
earlier in this section.
We solicited comment on these proposals and our summary of these
comments and responses are below.
Comment: Some commenters expressed concern that CMS has gone back
to an ``all or nothing'' approach, which existed in the original
meaningful use program. Commenters indicated that under CMS' proposal,
clinicians would be required to report on all required measures within
each of the four objectives. Failure to report on one measure without
claiming an exclusion would result in a score of zero. Other commenters
stated that the proposed new structure is still essentially an ``all or
nothing'' approach, which they do not support. Instead, they suggested
that MIPS eligible clinicians who do not or cannot attest to a measure
should not receive points for that particular measure, but they should
still earn points for all of the other measures that they are able to
submit data for.
Response: We tried to reduce confusion and clinician burden by
proposing to reduce the number of measures that MIPS eligible
clinicians are required to report and provide an opportunity for MIPS
eligible clinicians to earn points by redistributing the points to
other measures when an exclusion is claimed. We do not agree that this
scoring structure is an all or nothing approach due to the reduction of
measures, the requirement of a one in the numerator for numerator/
denominator measures or a ``yes'' for yes/no measures, and the
redistribution of points when an exclusion is claimed. We do not agree
with the suggestion that MIPS eligible clinicians that do not or cannot
attest to measures should not receive points since the measures have
been reduced to six required measures which will reduce administrative
burden and allow MIPS eligible clinicians to focus more on their
patients. We believe it would disadvantage clinicians if we did not
redistribute the points for measures when an exclusion is claimed. We
believe the proposed scoring methodology promotes the goals of the
performance category to focus on interoperability, improving patient
access to health information and aligning the performance category with
the Medicare Promoting Interoperability Program for eligible hospitals
and CAHs.
Comment: One commenter agreed with the CMS proposal to give a MIPS
eligible clinician a Promoting Interoperability performance category
score of ``zero'' for failure to report on any one required measure,
but recommended that CMS create an exclusion process with identified
circumstances where partial credit for the measure may be applied, but
such partial credit should be the exception and not the norm and should
be evaluated on a case-by-case basis.
Response: We appreciate the suggestion but believe it would further
complicate scoring when we are trying to simplify it to the greatest
extent possible. Our intention with our proposals for the scoring
methodology was to reduce clinician burden. We do not believe that a
process to address individual scenarios is feasible for us to implement
at this time, but will take this comment into consideration for future
rulemaking.
Comment: One commenter requested clarification of our proposal to
require MIPS eligible clinicians to report on all of the required
measures across all objectives in order to earn any score at all for
the Promoting Interoperability performance category. The commenter
questioned if failure to report any required measure would result in a
zero for that measure or a zero for the Promoting Interoperability
performance category.
Response: The clinician would earn a score of zero for the entire
Promoting Interoperability performance category.
Comment: Some commenters expressed concern with the time required
to incorporate new measures into CEHRT (an average of 1,000 hours per
measure per product) and requested that measures changes be done
judiciously to minimize the burden to developers and to MIPS eligible
clinicians who must implement the new measures.
Response: The proposed scoring methodology primarily would
eliminate or revise existing measures, which should only require
consolidation of existing workflows and actions. In addition, the
certification criteria and standards for EHR technology would remain
the same as finalized in the October 16, 2015 final rule titled ``2015
Edition Health Information Technology (Health IT) Certification
Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition,
and ONC Health IT Certification Program Modifications'' (80 FR 62602
through 62759).
Comment: One commenter stated that we should not require a minimum
numerator of 1 for any of the performance measures, but instead we
should require all program participants to report on all of the
performance measures, with an exclusion available for each measure in
case their CEHRT does not support the measure. If the exclusion is
claimed, the participant would receive a 0 on that measure, and the
exclusion status would be published on Physician Compare.
Response: We disagree with the commenter's suggested approach.
CEHRT presently has the capability to support all of the proposed
measures with the exception of the Query of Prescription Drug
Monitoring measure and the Verify Opioid Treatment Agreement measure,
which would be optional in the 2019 MIPS performance period. For more
information on what will be posted on Physician Compare, see section
III.I.3.l. of this final rule.
Comment: One commenter suggested an alternative intermediate
solution where each measure would be worth up to 10 points for a total
of 110 points (90 for the existing performance measures plus e-
Prescribing plus a second registry measure).
Response: We appreciate this suggestion, but we believe that
removing several of the existing performance score measures will help
to reduce burden for MIPS eligible clinicians.
Comment: Many commenters supported CMS' proposal to reduce the
number of measures to be reported as part of the Promoting
Interoperability performance category.
Response: We believe the reduction in reporting will relieve health
care provider burden through a more flexible, performance-based
approach.
Comment: Some commenters supported the CMS effort to reduce the
complexity of the scoring methodology. Some commenters stated that the
proposed scoring methodology reduces clinician burden by eliminating
confusing base and performance scores in favor of scoring at the
individual measure level, with relevant measure exclusions. Some
commenters supported the overall reduction of measures in this category
through the elimination of burdensome measures. Another commenter
indicated that the proposed scoring methodology and measure set is a
huge improvement and does a lot to streamline the requirements of the
Promoting Interoperability performance category. Commenters supported
the move to a

[[Page 59793]]

single set of measures because it will help alleviate confusion by MIPS
eligible clinicians. Many commenters supported CMS' proposed scoring
methodology in which MIPS eligible clinicians would be required to
report certain measures from each of the four objectives, with
performance-based scoring occurring at the individual measure-level.
Response: We appreciate the many commenters who supported the
proposed scoring methodology and agree it will reduce burden.
Comment: A few commenters stated they favored a system that
provides the flexibility for MIPS eligible clinicians to select the
measures most relevant to their practice and patient population and are
the least burdensome to implement.
Response: We believe the proposed scoring methodology approach,
including the reduction of measures to reduce reporting burden and our
goal to provide patients with access to their health information
promotes the goals of the Promoting Interoperability performance
category. Providing flexibility to choose measures that do not promote
increased focus on interoperability or improving patient access to
health information will deemphasize the goals of the Promoting
Interoperability performance category. We received many comments
indicating that there were too many measures so to address that we have
reduced and combined measures to reduce MIPS eligible clinician burden.
Comment: One commenter supported this specific proposal to
streamline and simplify the Promoting Interoperability performance
category, but cautioned CMS against further implementation of major
category overhauls. Significant changes, even those intended to reduce
physician reporting burden, can increase burden when they require yet
another round of health care provider and staff education to understand
how to maximize performance under a redesigned category scoring
methodology. Solo practitioners and small group practices in particular
have indicated that substantial category changes are significant
burdens for their practices.
Response: We appreciate the commenter's support for our proposal
and will take the recommendation against further implementation of
major category overhaul into consideration in future rulemaking. We
note that in the CY 2018 Quality Payment Program final rule (82 FR
53682-53683), we finalized a significant hardship exception for the
Promoting Interoperability performance category for MIPS eligible
clinicians who are in small practices.
Comment: A few commenters disagreed with our proposal to combine
the Request/Accept Summary of Care measure with the Clinical
Information Reconciliation measure and they proposed that each measure
remain separate and be worth 10 points, rather than having them
combined and worth 20 points.
Response: We thank commenters for their suggestion but we decline
to adopt it. For the reasons discussed in section III.I.3.h.(5)(f) of
this final rule, we believe it is appropriate to combine these measures
and have the point value reflect the combination.
Comment: Many commenters recommended that we establish a threshold
of 50 points to align with the Medicare Promoting Interoperability
Program for eligible hospitals and CAHs.
Response: Although our proposed scoring methodology did not include
a point threshold, we appreciate this comment and will take it into
consideration as we develop future proposals.
Comment: A commenter supported the proposed weighting of the
measures but recommended that CMS consider adding additional measures
that would promote the integration of clinical and administrative data
toward the goal of creating substantive longitudinal patient records.
Response: We appreciate the support and appreciate the suggestion.
In the proposed rule we did request comments (83 FR 35931 through
35932) on potential new measures as well as ways to link the quality,
improvement activities, and the Promoting Interoperability performance
categories. We plan to use the comments we received to inform future
proposals that focus on integration.
Comment: Some commenters thanked CMS for aligning the measures in
the inpatient and outpatient settings because it will reduce burden.
Response: We appreciate commenter's support of our proposal to
align the MIPS Promoting Interoperability performance category measures
with the Medicare Promoting Interoperability Program measures for
eligible hospitals and CAHs.
Comment: Some commenters stated that CMS should not implement the
alternative scoring approach that was considered and discussed in the
proposed rule because it would allow MIPS eligible clinicians to report
on fewer measures and still earn the same credit which is a lowering of
the bar for achieving interoperability. Many commenters suggested that
the Public Health and Clinical Data Exchange objective would be
deemphasized by reducing the reporting requirement to only one measure.
Response: We agree and will not be implementing the alternative
that we considered. Our primary proposal focuses on interoperability
and improving patient access to health information and we believe that
the objectives and measures we have chosen will help to fulfill these
goals. We agree that reporting to two different public health agencies
or clinical data registries for any of the measures from the Public
Health and Clinical Data Exchange objective will help to build bi-
directional data exchange between clinicians and public health agencies
and clinical data registries. We believe that our proposal will enable
MIPS eligible clinicians to push themselves on measures that are the
most applicable to how they deliver care to patients.
Comment: Many commenters supported CMS' alternative approach to
scoring in which scoring would occur at the objective level, instead of
the individual measure level, and MIPS eligible clinicians would be
required to report on only one measure from each objective to earn a
score for that objective.
Some commenters stated that requiring MIPS eligible clinicians to
report on every single measure or claim an exclusion creates an unfair
burden. Other commenters supported the alternative approach because
they believe it is less rigid and provides MIPS eligible clinicians
with more flexibility to report measures that are part of their
workflow.
Response: We have taken commenters' feedback into consideration as
we have constructed our final policy as outlined in section
III.I.3.h.(5)(d) of this final rule. We decline to finalize the
alternative approach to scoring. In addition, the other objectives
containing more than one measure are the Electronic Prescribing
objective and the Health Information Exchange objective. For the
Electronic Prescribing objective, we note that both the Query of PDMP
and Verify Opioid Treatment Agreement measures are optional for
reporting for CY 2019; therefore we believe this objective could
require reporting on only one measure as opposed to multiple measures.
We continue to believe that the objective and measure set that we
selected will enable MIPS eligible clinicians to focus on
interoperability and improving patient access to health information.

[[Page 59794]]

Comment: A commenter recommended that CMS only require that MIPS
eligible clinicians attest to satisfying each measure for a least 1
patient instead of using a performance rate.
Response: We disagree. We believe that a performance-based scoring
mechanism will enable MIPS eligible clinicians who perform well on
measures to differentiate themselves from other MIPS eligible
clinicians who submitted data with lower results for the Promoting
Interoperability performance category.
Comment: One commenter suggested that if a MIPS eligible clinician
cannot fulfill a measure that an exclusion process be created where
partial credit can be earned. They recommended that partial credit be
granted on a case-by-case basis.
Response: We do not believe that finalizing a process to address
individual scenarios is feasible for us to implement at this time. We
may take this comment into consideration in our development of future
rulemaking.
Comment: One commenter supported all of the proposed measures as
long as there is no minimum threshold requirement and no performance
measurement.
Response: The Promoting Interoperability performance category sets
a very low minimum threshold requirement for measures. We believe that
the minimum reporting requirements we set (a one in the numerator for
numerator/denominator measures, a ``yes'' for yes/no measures, unless
an exclusion is claimed) are appropriate. We believe that a performance
based scoring system as we are implementing for the Promoting
Interoperability performance category will enable high performing MIPS
eligible clinicians to distinguish themselves from others and
potentially earn a higher upward adjustment.
Comment: One commenter urged CMS to allow MIPS eligible clinicians
to ``pick and choose'' measures from a ``menu'' of objectives and
measures. Other commenters recommended that the Promoting
Interoperability performance category not be limited to a small set of
measures. The commenters recommended more flexibility by allowing MIPS
eligible clinicians to select from a larger list of measures.
Response: We disagree because we allowed considerable choice for
years one and two and received significant feedback about how
complicated it was for clinicians to understand the requirements for
the base and performance scores. We continue to believe that a reduced
set of measures will reduce burden for clinicians and will enable them
to focus more on patient care. As we have received significant
commenters support on our proposal to align the Promoting
Interoperability requirements and measures with the Medicare Promoting
Interoperability Program measures for eligible hospitals and CAHs, we
decline to retain measures so that MIPS eligible clinicians have
flexibility in selecting measures.
Comment: A commenter stated that if CMS does not remove the ``all
or nothing'' scoring requirement, we recommend that the proposals
related to re-weighting measures when a MIPS eligible clinician claims
an exclusion be modified because they are confusing.
Response: While we understand that concern, we believe that if a
MIPS eligible clinician meets the requirements of an exclusion, then
the points for the excluded measure should be redistributed to another
measure. We will develop educational tools to assist MIPS eligible
clinicians to understand our redistribution policy.
Comment: A commenter stated that MIPS eligible clinicians rely on
their EHR systems to help them with program participation. They warned
that if these proposed changes are finalized in November 2018 for the
2019 performance period, the systems will not be updated until mid-2019
at the earliest. They requested a full calendar year's notice before
any changes would become applicable.
Response: We disagree that a full calendar year's notice is
necessary. The proposed new measure, Support Electronic Referral Loops
by Receiving and Incorporating Health Information, includes two
exclusions in CY 2019, as described in section III.I.3.h.(5)(f) of the
preamble of this final rule. For the Electronic Prescribing objective,
we note that both the Query of PDMP and Verify Opioid Treatment
Agreement measures are optional for reporting for CY 2019.The criteria
for all of the remaining measures (numerator/denominator or yes/no
measures) would remain the same and are supported by 2015 Edition
CEHRT.
Summary of Final Scoring Methodology: As discussed above, after
consideration of the comments we received, we are finalizing our
proposed performance-based scoring methodology for the Promoting
Interoperability performance category beginning with the performance
period in CY 2019, with modifications, as described below.
For additional measure-specific information, we refer readers to
section III.I.3.h.(5)(f) the preamble of this final rule.
Promoting Interoperability Score: We are finalizing that MIPS
eligible clinicians are required to report certain measures from each
of the four objectives, with performance-based scoring occurring at the
individual measure-level. Each measure is scored based on the MIPS
eligible clinician's performance for that measure, except for the
measures associated with the Public Health and Clinical Data Exchange
objective, which require a yes/no attestation. Each measure will
contribute to the MIPS eligible clinician's total Promoting
Interoperability performance category score. The scores for each of the
individual measures are added together to calculate the total Promoting
Interoperability performance category score of up to 100 possible
points for each MIPS eligible clinician. To calculate the Promoting
Interoperability performance category score, the measure scores are
added together, and the total sum is divided by the total possible
points (100). The total sum cannot exceed the total possible points.
This calculation results in a fraction from zero to 1, which can be
formatted as a percent. For a MIPS eligible clinician to earn a score
greater than zero for the Promoting Interoperability performance
category, in addition to completing the actions included in the
Security Risk Analysis measure, the MIPS eligible clinician must submit
their complete numerator and denominator or yes/no data for all
required measures. The numerator and denominator for each performance
measure will translate to a performance rate for that measure and will
be applied to the total possible points for that measure. The MIPS
eligible clinician must report on all of the required measures across
all of the objectives in order to earn any score at all. Failure to
report any required measure, or reporting a ``no'' response on a yes/no
response measure, unless an exclusion is claimed will result in a
Promoting Interoperability performance category score of zero.
Security Risk Analysis Measure: We are finalizing our proposal that
MIPS eligible clinicians must attest to having completed the actions
included in the Security Risk Analysis measure at some point during the
calendar year in which the MIPS performance period occurs. The Security
Risk Analysis measure is not scored and does not contribute any points
to the MIPS eligible clinician's total score for the objectives and
measures.
Electronic Prescribing Objective Scoring: We are finalizing the
Electronic

[[Page 59795]]

Prescribing objective as proposed with the following modifications. The
e-Prescribing measure is worth up to 10 points in CYs 2019 and 2020. We
are modifying the points for CY 2020 to reflect the modification to our
proposal for the Query of Prescription Drug Monitoring Program (PDMP)
measure in CY 2020. The Query of PDMP measure is optional in CY 2019
and worth 5 bonus points. We are not establishing a policy for the
Query of PDMP measure for CY 2020 in this final rule and intend to
address this measure in future rulemaking. The Verify Opioid Treatment
Agreement measure is optional in CY 2019 and 2020, and worth five bonus
points. We intend to reevaluate the status of the Verify Opioid
Treatment Agreement measure for subsequent years in future rulemaking.
An exclusion is available for the e-Prescribing measure as described in
section III.I.3.h.(5)(f) of the preamble of this final rule. If an
exclusion is claimed for the e-Prescribing measure for CY 2019, the 10
points for the e-Prescribing measure will be redistributed equally
among the measures associated with the Health Information Exchange
objective. Since the Query of PDMP and Verify Opioid Treatment
Agreement measures are optional and eligible for bonus points, no
exclusions are available.
Health Information Exchange Objective Scoring: We are finalizing
the Health Information Exchange objective as proposed. The Support
Electronic Referral Loops by Sending Health Information measure is
worth up to 20 points. An exclusion is available for this measure, as
described in section III.I.3.h.(5)(f) of the preamble of this final
rule, although we did not address in the proposed rule how the points
would be redistributed in the event the exclusion is claimed. We intend
to propose in next year's rulemaking how the points will be
redistributed if an exclusion is claimed. The new measure, Support
Electronic Referral Loops by Receiving and Incorporating Health
Information, is worth up to 20 points. Exclusions are available for
this measure, as described in section III.I.3.h.(5)(f) of this final
rule. If an exclusion is claimed, the 20 points would be redistributed
to the other measure within this objective, the Support Electronic
Referral Loops by Sending Health Information measure, which would be
worth up to 40 points. We will address in future rulemaking how the
points will be redistributed if exclusions are claimed for both the
Support Electronic Referral Loops by Sending Health Information measure
and the Support Electronic Referral Loops by Receiving and
Incorporating Health Information measure.
Provider to Patient Exchange Objective Scoring: We are finalizing
the Provider to Patient Exchange objective with modifications. The
Provide Patients Electronic Access to Their Health Information measure
is worth up to 40 points beginning with the MIPS performance period in
CY 2019. No exclusions are available for this measure.
Public Health and Clinical Data Exchange Objective Scoring: We are
finalizing the Public Health and Clinical Data Exchange objective as
proposed with the following modifications. MIPS eligible clinicians
must submit a yes/no response for two different public health agencies
or clinical data registries for any of the measures associated with the
Public Health and Clinical Data Exchange objective to earn 10 points
for the objective. Failure to report on two different public health
agencies or clinical data registries or submitting a ``no'' response
for a measure will earn a score of zero. Exclusions available for this
objective are discussed in section III.I.3.h.(5)(f) of the preamble of
this final rule. If an exclusion is claimed for one measure, but the
MIPS eligible clinicians submits a ``yes'' response for another
measure, they would earn the 10 points for the Public Health and
Clinical Data Exchange objective. If a MIPS eligible clinician claims
exclusions for both measures they select to report on, the 10 points
would be redistributed to the Provide Patients Electronic Access to
Their Health Information measure under the Provider to Patient Exchange
objective.
Tables 41 and 42 reflect the final policy for the objectives,
measures, and maximum points available for the MIPS performance periods
in CY 2019 and CY 2020. Please note, the maximum points available do
not include points that would be redistributed in the event an
exclusion is claimed:
Tables 41 and 42 illustrate our final performance-based scoring
methodology.

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We proposed to codify the proposed new scoring methodology in new
paragraphs (b)(4)(ii) and (iii) under Sec. 414.1380 and we are
finalizing the proposed regulation text with modification.
(e) Promoting Interoperability/Advancing Care Information Objectives
and Measures Specifications for the 2018 Performance Period
The Advancing Care Information (now Promoting Interoperability)
performance category Objectives and Measures for the 2018 performance
period are as follows. For more information, we refer readers to the CY
2017 Quality Payment Program and CY 2018 Quality Payment Program final
rules (81 FR 77227 through 77229, and 82 FR 53674 through 53680,
respectively).

Objective: Protect Patient Health Information.
Objective: Protect electronic protected health information (ePHI)
created or maintained by the CEHRT through the

[[Page 59797]]

implementation of appropriate technical, administrative, and physical
safeguards.
Security Risk Analysis Measure: Conduct or review a security risk
analysis in accordance with the requirements in 45 CFR 164.308(a)(1),
including addressing the security (to include encryption) of ePHI data
created or maintained by CEHRT in accordance with requirements in
Sec. Sec. 164.312(a)(2)(iv) and 164.306(d)(3), implement security
updates as necessary, and correct identified security deficiencies as
part of the MIPS eligible clinician's risk management process.
Objective: Electronic Prescribing.
Objective: Generate and transmit permissible prescriptions
electronically.
e-Prescribing Measure: At least one permissible prescription
written by the MIPS eligible clinician is queried for a drug formulary
and transmitted electronically using CEHRT.
Denominator: Number of prescriptions written for drugs requiring a
prescription in order to be dispensed other than controlled substances
during the performance period; or number of prescriptions written for
drugs requiring a prescription in order to be dispensed during the
performance period.
Numerator: The number of prescriptions in the denominator
generated, queried for a drug formulary, and transmitted electronically
using CEHRT.
Exclusion: Any MIPS eligible clinician who writes fewer than 100
permissible prescriptions during the performance period.

Objective: Patient Electronic Access.
Objective: The MIPS eligible clinician provides patients (or
patient-authorized representative) with timely electronic access to
their health information and patient-specific education.
Patient Access Measure: For at least one unique patient seen by the
MIPS eligible clinician: (1) The patient (or the patient-authorized
representative) is provided timely access to view online, download, and
transmit his or her health information; and (2) The MIPS eligible
clinician ensures the patient's health information is available for the
patient (or patient-authorized representative) to access using any
application of their choice that is configured to meet the technical
specifications of the Application Programing Interface (API) in the
MIPS eligible clinician's CEHRT.
Denominator: The number of unique patients seen by the MIPS
eligible clinician during the performance period.
Numerator: The number of patients in the denominator (or patient
authorized representative) who are provided timely access to health
information to view online, download, and transmit to a third party and
to access using an application of their choice that is configured meet
the technical specifications of the API in the MIPS eligible
clinician's CEHRT.
Patient-Specific Education Measure: The MIPS eligible clinician
must use clinically relevant information from CEHRT to identify
patient-specific educational resources and provide electronic access to
those materials to at least one unique patient seen by the MIPS
eligible clinician.
Denominator: The number of unique patients seen by the MIPS
eligible clinician during the performance period.
Numerator: The number of patients in the denominator who were
provided electronic access to patient-specific educational resources
using clinically relevant information identified from CEHRT during the
performance period.

Objective: Coordination of Care Through Patient Engagement.
Objective: Use CEHRT to engage with patients or their authorized
representatives about the patient's care.
View, Download, Transmit (VDT) Measure: During the performance
period, at least one unique patient (or patient-authorized
representatives) seen by the MIPS eligible clinician actively engages
with the EHR made accessible by the MIPS eligible clinician by either:
(1) Viewing, downloading or transmitting to a third party their health
information; or (2) accessing their health information through the use
of an API that can be used by applications chosen by the patient and
configured to the API in the MIPS eligible clinician's CEHRT; or (3) a
combination of (1) and (2).
Denominator: Number of unique patients seen by the MIPS eligible
clinician during the performance period.
Numerator: The number of unique patients (or their authorized
representatives) in the denominator who have viewed online, downloaded,
or transmitted to a third party the patient's health information during
the performance period and the number of unique patients (or their
authorized representatives) in the denominator who have accessed their
health information through the use of an API during the performance
period.
Secure Messaging Measure: For at least one unique patient seen by
the MIPS eligible clinician during the performance period, a secure
message was sent using the electronic messaging function of CEHRT to
the patient (or the patient-authorized representative), or in response
to a secure message sent by the patient (or the patient-authorized
representative).
Denominator: Number of unique patients seen by the MIPS eligible
clinician during the performance period.
Numerator: The number of patients in the denominator for whom a
secure electronic message is sent to the patient (or patient-authorized
representative) or in response to a secure message sent by the patient
(or patient-authorized representative), during the performance period.
Patient-Generated Health Data Measure: Patient-generated health
data or data from a non-clinical setting is incorporated into the CEHRT
for at least one unique patient seen by the MIPS eligible clinician
during the performance period.
Denominator: Number of unique patients seen by the MIPS eligible
clinician during the performance period.
Numerator: The number of patients in the denominator for whom data
from non-clinical settings, which may include patient-generated health
data, is captured through the CEHRT into the patient record during the
performance period.

Objective: Health Information Exchange.
Objective: The MIPS eligible clinician provides a summary of care
record when transitioning or referring their patient to another setting
of care, receives or retrieves a summary of care record upon the
receipt of a transition or referral or upon the first patient encounter
with a new patient, and incorporates summary of care information from
other health care providers into their EHR using the functions of
CEHRT.
Send a Summary of Care Measure: For at least one transition of care
or referral, the MIPS eligible clinician that transitions or refers
their patient to another setting of care or health care provider (1)
creates a summary of care record using CEHRT; and (2) electronically
exchanges the summary of care record.
Denominator: Number of transitions of care and referrals during the
performance period for which the MIPS eligible clinician was the
transferring or referring clinician.
Numerator: The number of transitions of care and referrals in the
denominator where a summary of care record was created using CEHRT and
exchanged electronically.

[[Page 59798]]

Exclusion: Any MIPS eligible clinician who transfers a patient to
another setting or refers a patient fewer than 100 times during the
performance period.
Request/Accept Summary of Care Measure: For at least one transition
of care or referral received or patient encounter in which the MIPS
eligible clinician has never before encountered the patient, the MIPS
eligible clinician receives or retrieves and incorporates into the
patient's record an electronic summary of care document.
Denominator: Number of patient encounters during the performance
period for which a MIPS eligible clinician was the receiving party of a
transition or referral or has never before encountered the patient and
for which an electronic summary of care record is available.
Numerator: Number of patient encounters in the denominator where an
electronic summary of care record received is incorporated by the
clinician into the CEHRT.
Exclusion: Any MIPS eligible clinician who receives transitions of
care or referrals or has patient encounters in which the MIPS eligible
clinician has never before encountered the patient fewer than 100 times
during the performance period.
Clinical Information Reconciliation Measure: For at least one
transition of care or referral received or patient encounter in which
the MIPS eligible clinician has never before encountered the patient,
the MIPS eligible clinician performs clinical information
reconciliation. The MIPS eligible clinician must implement clinical
information reconciliation for the following three clinical information
sets: (1) Medication. Review of the patient's medication, including the
name, dosage, frequency, and route of each medication; (2) Medication
allergy. Review of the patient's known medication allergies; and (3)
Current Problem list. Review of the patient's current and active
diagnoses.
Denominator: Number of transitions of care or referrals during the
performance period for which the MIPS eligible clinician was the
recipient of the transition or referral or has never before encountered
the patient.
Numerator: The number of transitions of care or referrals in the
denominator where the following three clinical information
reconciliations were performed: Medication list; medication allergy
list; and current problem list.

Objective: Public Health and Clinical Data Registry Reporting.
Objective: The MIPS eligible clinician is in active engagement with
a public health agency or clinical data registry to submit electronic
public health data in a meaningful way using CEHRT, except where
prohibited, and in accordance with applicable law and practice.
Immunization Registry Reporting Measure: The MIPS eligible
clinician is in active engagement with a public health agency to submit
immunization data and receive immunization forecasts and histories from
the public health immunization registry/immunization information system
(IIS).
Syndromic Surveillance Reporting Measure: The MIPS eligible
clinician is in active engagement with a public health agency to submit
syndromic surveillance data from a non-urgent care setting.
Electronic Case Reporting Measure: The MIPS eligible clinician is
in active engagement with a public health agency to electronically
submit case reporting of reportable conditions.
Public Health Registry Reporting Measure: The MIPS eligible
clinician is in active engagement with a public health agency to submit
data to public health registries.
Clinical Data Registry Reporting Measure: The MIPS eligible
clinician is in active engagement to submit data to a clinical data
registry.
(f) Promoting Interoperability Performance Category Measures for MIPS
Eligible Clinicians
(i) Measure Summary Overview
In the CY 2019 PFS proposed rule (83 FR 35920 through 35932), we
proposed to adopt beginning with the performance period in 2019 the
existing Promoting Interoperability objectives and measures as
finalized in the CY 2018 Quality Payment Program final rule (82 FR
53674 through 53680) with several proposed changes as discussed herein,
including the addition of new measures, removal of some of the existing
measures, and modifications to the specifications of some of the
existing measures. We did not propose to continue the Promoting
Interoperability transition objectives and measures (see 82 FR 53674
through 53676) beyond the 2018 MIPS performance period because the 2015
Edition of CEHRT will be required beginning with the MIPS performance
period in 2019. Our intent for these proposed changes is to ensure the
measures better focus on the effective use of health IT, particularly
for interoperability, and to address concerns stakeholders have raised
through public forums and in public comments related to the perceived
burden associated with the current measures in the program. As stated
in the CY 2017 Quality Payment Program final rule (81 FR 77216) our
priority is to finalize reporting requirements for the Promoting
Interoperability performance category that incentivizes performance and
reporting with minimal complexity and reporting burden. In addition, we
acknowledged that while we believe all of the measures of the Promoting
Interoperability performance category are important, we must also
balance the need for these data with data collection and reporting
burden (81 FR 77221).
In CY 2017, we initiated an informal process outside of rulemaking
for submission of new Promoting Interoperability performance category
measures for potential inclusion in the Year 3 Quality Payment Program
proposed rule. We prioritized measures that build on interoperability
and health information exchange, the advanced use of CEHRT using 2015
Edition Standards and Certification Criteria, improve program
efficiency and flexibility, measure patient outcomes, emphasize patient
safety, and support improvement activities and quality performance
categories of MIPS. In addition, and as we indicated in the CY 2018
Quality Payment Program proposed rule (82 FR 30079), we sought new
measures that may be more broadly applicable to MIPS eligible
clinicians who are Nurse Practitioners (NPs), Physician Assistants
(PAs), Certified Registered Nurse Anesthetists (CRNAs) and Clinical
Nurse Specialists (CNSs).
During this initial submission period, various MIPS eligible
clinicians, stakeholders and health IT developers submitted new
measures for consideration via an application posted on the CMS
website, now hosted at https://www.cms.gov/Regulations-and-Guidance/
Legislation/EHRIncentivePrograms/CallForMeasures.html. Through our
review process, which included representation from the ONC, as well as
various stakeholder listening sessions, we identified measure
submissions that met our criteria and aligned with the Promoting
Interoperability performance category goals and priorities, as well as
broader HHS initiatives related to the opioid crisis.\20\ As a result
of this process, we proposed two measures, Query of PDMP and Verify
Opioid Treatment Agreement.
---------------------------------------------------------------------------

\20\ https://www.hhs.gov/opioids/about-the-epidemic/;
https://www.healthit.gov/opioids.
---------------------------------------------------------------------------

We proposed to remove six measures from the Promoting
Interoperability objectives and measures beginning with the performance
period in 2019. Two of

[[Page 59799]]

the measures we proposed to remove--Request/Accept Summary of Care and
Clinical Information Reconciliation--would be replaced by the Support
Electronic Referral Loops by Receiving and Incorporating Health
Information measure, which combines the functionalities and goals of
the two measures it is replacing. Four of the measures--Patient-
Specific Education; Secure Messaging; View, Download, or Transmit; and
Patient-Generated Health Data--would be removed because they have
proven burdensome to MIPS eligible clinicians in ways that were
unintended and may detract from clinicians' progress on current program
priorities. We stated that although the measures proposed for removal
would no longer need to be submitted if we finalize the proposal to
remove them, MIPS eligible clinicians may still continue to use the
standards and functions of those measures based on the preferences of
their patients and their practice needs. We stated our belief that this
burden reduction would enable MIPS eligible clinicians to focus on new
measures that further interoperability, advances of innovation in the
use of CEHRT and the exchange of health care information.
As discussed in the proposed scoring methodology in section
III.H.3.h.(5)(f) of the proposed rule, we proposed to add three new
measures to the Promoting Interoperability objectives and measures
beginning with the performance period in 2019. For the e-Prescribing
objective, we proposed the two new measures referenced earlier, Query
of PDMP and Verify Opioid Treatment Agreement, both of which support
HHS initiatives related to the treatment of opioid and substance use
disorders by helping health care providers avoid inappropriate
prescriptions, improving coordination of prescribing amongst health
care providers and focusing on the advanced use of CEHRT. For the
Health Information Exchange objective, we proposed a new measure,
Support Electronic Referral Loops by Receiving and Incorporating Health
Information, which builds upon and replaces the existing Request/Accept
Summary of Care and Clinical Information Reconciliation measures, while
furthering interoperability and the exchange of health information.
We also proposed to modify some of the existing Promoting
Interoperability performance category objectives and measures beginning
with the performance period in 2019. We proposed to rename the Send a
Summary of Care measure to Support Electronic Referral Loops by Sending
Health Information. In addition, we proposed to rename the Patient
Electronic Access objective to Provider to Patient Exchange, and
proposed to rename the remaining measure, Provide Patient Access to
Provide Patients Electronic Access to Their Health Information. We
proposed to eliminate the Coordination of Care Through Patient
Engagement objective and all of its associated measures as described
earlier. Finally, we proposed to rename the Public Health and Clinical
Data Registry Reporting objective to Public Health and Clinical Data
Exchange and require reporting on at least two measures of the MIPS
eligible clinician's choice from the following: Immunization Registry
Reporting; Syndromic Surveillance Reporting, Electronic Case Reporting;
Public Health Registry Reporting; and Clinical Data Registry Reporting.
In addition, we proposed exclusion criteria for each of these measures.
Finally, we solicited comment on a potential new measure Health
Information Exchange Across the Care Continuum under the Health
Information Exchange objective in which a MIPS eligible clinician would
send an electronic summary of care record, or receive and incorporate
an electronic summary of care record, for transitions of care and
referrals with a health care provider other than a MIPS eligible
clinician. The measure would include health care providers in care
settings including but not limited to long term care facilities and
post-acute care providers such as skilled nursing facilities, home
health, and behavioral health settings.
As we stated in the proposed rule (83 FR 35921) we understand from
previous listening sessions that EHR vendors and developers will need
time to develop, test and implement new measures, and MIPS eligible
clinicians will need time to implement as well as establish and test
their processes and workflows. As indicated above and in the discussion
of the proposed scoring methodology in section III.H.3.h.(5)(d) of the
proposed rule, we proposed three new measures (Query of PDMP, Verify
Opioid Treatment Agreement, and Support Electronic Referral Loops by
Receiving and Incorporating Health Information). We proposed that the
Query of PDMP and Verify Opioid Treatment Agreement measures would be
optional for the performance period in 2019 and bonus points may be
earned for reporting on them. We proposed that the Support Electronic
Referral Loops by Receiving and Incorporating Health Information would
be required beginning with the performance period in 2019 with
exclusions available. We proposed to require the Query of PDMP and
Verify Opioid Treatment Agreement measures beginning with the
performance period in 2020, and we solicited public comment on this
proposal.
We noted that the proposals under the Health Information Exchange
objective require only consolidation of existing workflows and actions,
while certification criteria and standards remain the same as in the CY
2018 Quality Payment Program final rule (82 FR 53677 through 53678).
Therefore, we stated our belief that MIPS eligible clinicians could
potentially implement this new measure for the performance period in
2019.
The following is a summary of the comments we received on our
proposals.
Comment: One commenter stated that for some measures MIPS eligible
clinicians and group practices should be able to get credit for actions
that are taken outside of the 90-day performance period.
Response: Since the inception of the Quality Payment Program, we
have limited the ability to increment the numerator and denominator of
measures to actions occurring during the performance period chosen,
with the exception of the Security Risk Analysis measure for which the
relevant actions may occur any time during the calendar year. The MIPS
eligible clinician may select a MIPS performance period that exceeds
the 90-day minimum up to a maximum of the full calendar year if they
choose. (82 FR 53670).
(ii) Measure Proposals for the e-Prescribing Objective
In the CY 2019 PFS proposed rule (83 FR 35921 through 35925), we
proposed two new measures under the e-Prescribing objective. In the CY
2017 Quality Payment Program final rule, we stated that MIPS eligible
clinicians will have the option to include or not include controlled
substances in the definition of ``permissible prescriptions'' at their
discretion where feasible and allowable by law in the jurisdiction
where they provide care (81 FR 77227). We believe it is important to
consider other requirements specific to electronic prescribing of
controlled substances for health care providers to take into account
and how this may interact with the proposals under this rulemaking. We
are committed to combatting the opioid epidemic by making it a top
priority for the agency and aligning its efforts with the HHS opioid
initiative to combat misuse and promote programs that support treatment
and recovery support services.

[[Page 59800]]

We proposed to add two new measures to the e-Prescribing objective
that are based on electronic prescriptions for controlled substances
(EPCS): Query of PDMP; and Verify Opioid Treatment Agreement. These
measures build upon the meaningful use of CEHRT as well as the security
of electronic prescribing of Schedule II controlled substances while
preventing diversion. For both measures, we proposed to define opioids
as Schedule II controlled substances under 21 CFR 1308.12, as they are
recognized as having a high potential for abuse with potential for
severe psychological or physical dependence. We also proposed to apply
the same policies for the existing e-Prescribing measure to both the
Query of PDMP and Verify Opioid Treatment Agreement measures, including
the requirement to use CEHRT as the sole means of creating the
prescription and for transmission to the pharmacy. We stated that MIPS
eligible clinicians have the option to include or exclude controlled
substances in the e-Prescribing measure denominator as long as they are
treated uniformly across patients and all available schedules and in
accordance with applicable law. However, because the intent of these
two new measures is to improve prescribing practices for controlled
substances, MIPS eligible clinicians would have to include Schedule II
opioid prescriptions in the numerator and denominator or claim the
applicable exclusion. Additionally, we noted the intent of the proposed
measures is not to dissuade the prescribing or use of opioids for
patients with medical diagnoses or conditions that benefit from their
use, such as patients diagnosed with cancer or those receiving hospice.
We solicited comment on the impact that implementing this measure could
have on patients who receive opioids due to medical diagnoses such as
cancer or receiving hospice care as well as treatment of patients under
a program involving substance abuse education, treatment, or prevention
under 42 CFR part 2.
Additionally, we solicited comment on the federal and state
statutory and regulatory requirements that may impact implementation of
the Query of PDMP and Verify Opioid Treatment Agreement measures.
We stated that in the event we finalize the new scoring methodology
that we proposed in section III.H.3.h.(5)(d) of the proposed rule, MIPS
eligible clinicians who claim the exclusion under the existing e-
Prescribing measure would automatically receive an exclusion for all
three of the measures under the e-Prescribing objective; they would not
have to also claim exclusions for the other two measures, Query of PDMP
and Verify Opioid Treatment Agreement. We are not finalizing this
proposal because we are finalizing the two new measures (Query of PDMP
and Verify Opioid Treatment Agreement) are optional, so exclusions
would not be necessary for them.
(A) Query of Prescription Drug Monitoring Program (PDMP) Measure
As we stated in the proposed rule (83 FR 35922 through 35923), a
PDMP is an electronic database that tracks prescriptions of controlled
substances at the State level. PDMPs play an important role in patient
safety by assisting in the identification of patients who have multiple
prescriptions for controlled substances or may be misusing or overusing
them. Querying the PDMP is important for tracking the prescribed
controlled substances and improving prescribing practices. The ONC,
Centers for Disease Control and Prevention (CDC), Department of Justice
(DOJ) and Substance Abuse and Mental Health Services Administration
(SAMHSA) have had integral roles in the integration and expansion of
PMDPs with health information technology systems. For example, the ONC
and SAMHSA collaboratively led the ``Enhancing Access'' project to
improve health care provider access to PDMP data utilizing health
IT.\21\ Likewise, the CDC conducted a process and outcome evaluation of
the PDMP EHR Integration and Interoperability Expansion (PEHRIIE)
program funded by SAMHSA for nine states between FY 2012 and 2016. The
PEHRIIE program goals were to integrate PDMPs into health IT and
improve the comprehensiveness of PDMPs through initiating and/or
improving interstate data exchange.\22\ In addition, the Bureau of
Justice Assistance's Harold Rogers Prescription Monitoring Program
supports Prescription Drug Monitoring Program Information Exchange
(PMIX) through funding, the goal of PMIX is to help states implement a
cost-effective solution to facilitate interstate data sharing among
PDMPs.\23\ Integration of the PDMP with health information technology
systems supports improves access to PDMP data, minimizes changes to
current workflow and overall burden and optimizes prescribing
practices. The intent of the Query of the PDMP measure is to build upon
the current PDMP initiatives from Federal partners focusing on
prescriptions generated and dispensing of opioids.
---------------------------------------------------------------------------

\21\ https://www.healthit.gov/PDMP and https://www.healthit.gov/
sites/default/files/
work_group_document_integrated_paper_final_0.pdf.
\22\ https://www.cdc.gov/drugoverdose/pdf/pehriie_report-a.pdf.
\23\ https://www.bja.gov/funding/Category-5-awards.pdf.
---------------------------------------------------------------------------

Proposed Measure Description: For at least one Schedule II opioid
electronically prescribed using CEHRT during the performance period,
the MIPS eligible clinician uses data from CEHRT to conduct a query of
a Prescription Drug Monitoring Program (PDMP) for prescription drug
history, except where prohibited and in accordance with applicable law.
We stated that we recognize both the utility and value of
addressing PDMP EHR integration and further recognizes the majority of
states mandate use of State prescription monitoring programs (PMPs)
requiring prescribers/dispensers to access PMP.\24\ According to the
CDC, State-level policies that enhance PDMPs or regulate pain clinics
helped several states drive down opioid prescriptions and overdose
deaths.\25\ We stated that we are also further aware of the varying
integration approaches underway including efforts to integrate a state
PDMP into a health information exchange or EHR or other efforts to
enhance a user interface of some type, such as risk assessment tools or
red flags. We noted federal evaluation resources available to inform
integration efforts \26\ and believe integration is critical for
enhancing health care provider workflow, access to critical PDMP data,
and improving clinical care including prescription management.
---------------------------------------------------------------------------

\24\ https://www.namsdl.org/library/14D3122C-96F5-F53E-
E8F23E906B4DE09D/.
\25\ https://www.cdc.gov/drugoverdose/policy/successes.html.
\26\ https://www.cdc.gov/drugoverdose/pdf/pehriie_report-a.pdf.
---------------------------------------------------------------------------

We proposed that the query of the PDMP for prescription drug
history must be conducted prior to the electronic transmission of the
Schedule II opioid prescription. MIPS eligible clinicians would have
flexibility to query the PDMP using CEHRT in any manner allowed under
their State law.
Although the query of the PDMP may currently be burdensome for some
MIPS eligible clinicians as part of their current workflow practice, we
stated our belief that querying the PDMP is beneficial to optimal
prescribing practices and foresee progression toward fully automated
queries of the PDMP building upon the current initiatives at the State
level.
We proposed to include in this measure all permissible
prescriptions and dispensing of Schedule II opioids regardless of the
amount prescribed during an encounter in order for MIPS

[[Page 59801]]

eligible clinicians to identify multiple health care provider episodes
(physician shopping), prescriptions of dangerous combinations of drugs,
prescribing rates and controlled substances prescribed in high
quantities. We requested comment on these policy proposals, including
whether additional queries should be performed and under which
circumstances. In addition we solicited comment on whether the query
should have additional constraints concerning when it should be
performed.
Denominator: Number of Schedule II opioids electronically
prescribed using CEHRT by the MIPS eligible clinician during the
performance period.
Numerator: The number of Schedule II opioid prescriptions in the
denominator for which data from CEHRT is used to conduct a query of a
PDMP for prescription drug history except where prohibited and in
accordance with applicable law. A numerator of at least one is required
to fulfill this measure.
Exclusion (beginning in 2020): Any MIPS eligible clinician who is
unable to electronically prescribe Schedule II opioids in accordance
with applicable law during the performance period. We proposed that the
exclusion criteria would be limited to prescriptions of Schedule II
opioids as the measure action is limited to prescriptions of Schedule
II opioids only and does not include any other types of electronic
prescriptions. We also requested comment on the proposed exclusion
criteria and whether there are circumstances which may justify other
exclusions for the Query of PDMP measure and what those circumstances
might be including medical diagnoses such as cancer or patients under
care of hospice.
We noted that we also understand that PDMP integration is not
currently in widespread use for CEHRT, and many MIPS eligible
clinicians may require additional time and workflow changes at the
point of care before they can meet this measure without experiencing
significant burden. For instance, many MIPS eligible clinicians will
likely need to manually enter the data into CEHRT to document the
completion of the query of the PDMP action. In addition, some MIPS
eligible clinicians may also need to conduct manual calculation of the
measure. Even for those MIPS eligible clinicians that have achieved
successful integration of a PDMP with their EHR, this measure may not
be machine calculable, for instance, in cases where the MIPS eligible
clinician follows a link within the EHR to a separate PDMP system. For
the purposes of meeting this measure, we noted there is no existing
certification criteria for the query of a PDMP. However, we stated our
belief that the use of structured data captured in the CEHRT can
support querying a PDMP through the broader use of health IT. We
solicited public comment on whether ONC should consider adopting
standards and certification criteria to support the query of a PDMP,
and if such criteria were to be adopted, on what timeline should CMS
require their use to meet this measure.
We noted the NCPDP SCRIPT 2017071 standard for e-prescribing is now
available and can help to support PDMP and EHR integration. We
solicited public comment, especially from health care providers and
health IT developers on whether they believe use of this standard can
support MIPS eligible clinicians seeking to report on this measure, and
whether HHS should encourage use of this standard through separate
rulemaking.
We solicited comment on the challenges associated with querying the
PDMP with and without CEHRT integration and whether this proposed
measure should require certain standards, methods or functionalities to
minimize burden.
In including EPCS as a component of the measure as proposed, we
acknowledged and sought input on perceived and real technological
barriers as part of its effective implementation including but not
limited to input on two-factor authentication and on the effective and
appropriate uses of technology, including the use of telehealth
modalities to support established patient and health care provider
relationships subsequent to in-person visit(s) and for prescribing
purposes.
We also proposed that in order to meet this measure, a MIPS
eligible clinician must use the capabilities and standards as defined
for CEHRT at 45 CFR 170.315(a)(10)(ii) and (b)(3).
The following is a summary of the comments we received on these
proposals.
Comment: One commenter stated that the measure is overly burdensome
because view-only data is not sufficient for clinicians and data should
be in a format that is acceptable by the receiving EHR system.
Response: We agree that if data exchanged is not supported in a
computable format, it may create increased burden to the MIPS eligible
clinician. Although we believe the Query of PDMP measure is a necessary
step to combat the opioid crisis by taking advantage of health IT
capabilities, we agree that the lack of EHR integration with PDMPs is
an obstacle to widespread adoption of this measure. We will continue to
work with our colleagues across HHS and with stakeholders to develop
necessary standards and complementary resources to promote the
advancement of PDMP functionality. Over time, we believe the continued
advancement of this measure will help further patient safety and reduce
provider burden. We are providing bonus points for this measure in CY
2019 and will propose our policy for CY 2020 in future rulemaking.
Comment: Some commenters supported this new measure but stated that
there is little or no time for health IT developers to update their
products, receive certification and roll these products out to users.
Commenters requested that CMS give more lead-time for these type of
changes and have the Query of PDMP measure be optional in the 2019 and
2020 MIPS performance periods.
Other commenters stated that while PDMPs play an important role in
identifying high-risk patients, and recommended that CMS move more
slowly with requiring the measure until PDMPs are more fully integrated
into EHRs and clinician workflows.
Response: We acknowledge that there is currently no certified
functionality within CEHRT specific to connecting to a PDMP and that
support for integration between PDMP systems and EHRs varies widely
across States due to variations in laws and technical approaches. We
believe that functionality currently in CEHRT may support integration
with PDMP systems. While we understand the concern that there is not
specific certified functionality to meet this measure, we stated in the
proposed rule (83 FR 35923) that MIPS eligible clinicians have the
flexibility to query the PDMP in any manner allowed under their State
law. We also stated (83 FR 35923) that in order to meet the measure,
MIPS eligible clinicians must use the capabilities of their CEHRT
defined at Sec. 170.315(a)(10)(ii) and (b)(3).
The certification criteria defined at Sec. 170.315(b)(3) supports
this measure because it allows a MIPS eligible clinician to create a
new prescription, change a prescription, cancel a prescription, refill
a prescription, request fill status notifications and request and
receive medication history information to and from pharmacies. PDMPs
collect, monitor, and analyze electronically transmitted prescribing
and dispensing data submitted by pharmacies and dispensing
practitioners. Additionally, the CEHRT criteria defined at Sec.
170.315(a)(10)(ii) defines drug formulary checks, which

[[Page 59802]]

are the most useful when utilized with e-Prescribing. These criteria
ensure the availability of structured data to support PDMPs through the
broader use of health IT and may increase the efficiency and safety of
opioid prescribing, while potentially reducing the cost of care.
We are aware of the need for additional time to implement this
measure and thus we are making it optional in CY 2019 and will propose
our policy for this measure for CY 2020 in future rulemaking.
Comment: One commenter stated that CMS must recognize that the
Query of PDMP measure may not provide a complete picture of the
patient's medication history.
Response: We agree that the Query of PDMP measure may not provide a
complete picture of the patient's medication history; however, it can
provide the clinician with information to make a more informed clinical
decision, and we believe it is a valuable tool to consider in caring
for patients.
Comment: One commenter recommended that CMS and ONC work together
to develop a set of national standards for PDMPs, so that the
information can be exchanged across a variety of States. Another
commenter recommended CMS and ONC develop standards to allow access to
a PDMP through a HIE.
Response: We understand States have varying technical approaches
for PDMPs and that some states are pursuing strategies that utilize
HIEs to help clinicians access PDMPs. We believe these strategies are
an important way to increase interoperability and support clinicians'
ability to connect with PDMP systems.
We will continue to work with ONC and other stakeholders to
encourage the development of standards, which facilitate increased
interoperability between PDMPs and other systems, including HIEs and
clinician health IT systems.
Comment: A commenter stated that a State lacks a state-wide PDMP
and requested an exclusion for MIPS eligible clinicians who do not have
a State PDMP to query. Another commenter requested an exclusion for
MIPS eligible clinicians who do not prescribe any Schedule II opioids
during a 90-day performance period, because the lack of such exclusion
could result in MIPS eligible clinicians prescribing an unnecessary
Schedule II opioid just to avoid earning a zero for the Promoting
Interoperability performance category. One commenter requested that in
addition to the proposed exclusion CMS should add an exclusion for MIPS
eligible clinicians in states that do not support PDMP integration
using the NCPDP SCRIPT or SMART on FHIR standard.
Response: We decline to add any exclusions to the Query of PDMP
measure at this time. For CY 2019, exclusions are not available, as the
measure is optional.
Comment: Some commenters stated the development of interfaces to
connect EHRs to a PDMP vendor solution is underway, but there is a cost
to access the PDMP gateway. Other commenters noted that some states
charge clinicians fees to use a PDMP and a mandatory measure using
PDMPs could add considerable financial burden.
Response: Our goal of burden reduction includes consideration of
costs associated with meeting the Promoting Interoperability
performance category requirements. We will continue to listen to
feedback related to costs and mitigate burden wherever possible and as
practicable within the MIPS programs. We will also continue to work
with HHS partners and other stakeholder in the creation, harmonization,
and promotion of free and open source interoperability standards for
EHRs and PDMPs, and we encourage PDMPs across the country to connect to
the free and open source RxCheck, a fully operational national hub that
enables states to securely and efficiently share PDMP data.
Comment: A few commenters stated that this measure should be Yes/No
reporting instead of reporting a numerator and denominator since some
states require health care providers to download current PDMP results
that are not incorporated into CEHRT. The commenter further stated that
having this measure as a numerator/denominator will create significant
challenges to capture and calculate the performance of this measure.
Response: We decline to change the format of the measure to a Yes/
No metric as we believe that a numerator/denominator reporting format
captures the intent of the measure, which is to identify multiple
provider episodes (physician shopping), prescriptions of dangerous
combinations of drugs, prescribing rates and controlled substances
prescribed in high quantities. We believe MIPS eligible clinicians need
to demonstrate their performance in meeting these opioid measures.
Comment: A commenter questioned what documentation is required to
indicate that they fulfilled the Query of PDMP measure. The commenter
stated that in the 2020 MIPS performance period, when the measure is
required, MIPS eligible clinicians will need time to figure out how to
generate the appropriate documentation.
Response: We understand that many clinicians may be required to
manually calculate this measure, and we plan to issue guidance
regarding the documentation to retain. This may include MIPS eligible
clinicians with EHR-integrated PDMPs, who still have to manually
calculate the measure due to the lack of automated functionality. Due
to challenges with reporting on this new measure, we will determine
through future rulemaking the status of this measure for the 2020 MIPS
performance period and beyond.
Comment: A commenter requested that the denominator of the measure
be changed from ``electronically prescribed'' to all prescribed
Schedule II opioids because entities that are barred from e-prescribing
controlled substances would still benefit from incorporating PDMP
queries into their workflows.
Response: As we stated in the proposed rule (83 FR 35922), intent
of the Query of the PDMP measure is to build upon current PDMP
initiatives from federal partners focusing on prescriptions generated
and dispensing of opioids. The objectives and measures for the
Promoting Interoperability performance category focus on the use of
CEHRT. Therefore we decline to expand the denominator of the measure to
include Schedule II opioids that are not electronically prescribed.
Comment: One commenter requested clarification as to whether the
numerator is intended to capture PMDP queries or user acknowledgement
of conducting a PDMP query.
Response: The numerator captures instances were a MIPS eligible
clinician conducts a query of a PDMP for prescription medication
history, except where prohibited and in accordance with the applicable
law. We understand that many clinician systems may not have the ability
to capture the number of PDMP queries in an automated fashion, and that
these clinicians may need to capture the data and calculate the measure
manually. The intent of the measure is to identify multiple provider
episodes (physician shopping), prescriptions of dangerous combinations
of drugs, prescribing rates and controlled substances prescribed in
high quantities.
Comment: A commenter stated that many state PDMPs are not ready to
implement direct integration of the PDMP with the EHR. Many commenters
stated that this functionality needs to be a part of CEHRT, so that
prescribers do not need to leave their EHR and log into a separate
system to conduct the query

[[Page 59803]]

of the PDMP. Commenters suggested that CMS redesign the measure so that
only direct integration is included.
Response: We agree that there are issues associated with the
integration of the PDMP with CEHRT and that is why we will establish
our policies for the measure for CY 2020 and beyond in future
rulemaking.
Comment: One commenter recommended that CMS allow MIPS eligible
clinicians to use a health information exchange to access the Schedule
II opioid prescription drug history and earn extra points.
Response: We have stated that clinicians may query the PDMP in any
fashion allowed under applicable state law, which would include the use
of HIEs to access PDMP data.
Comment: A commenter recommended CMS and ONC work together with
PDMPs, PDMP health IT vendors, and key standards development
organizations (NCPDP and HL7 in particular) to address the
interoperability and integration issues when using PDMPs. We note that,
while NCPDP provides medication history query specifications that CEHRT
support as part of their electronic prescribing capabilities, none of
the PDMPs currently support these. The commenter suggested that
consideration should be given whether comprehensive interoperability
with PDMPs to support both clinicians and patients would benefit from
the use of HL7 FHIR(copyright) standards.
Response: We recognize that interoperability and integration
efforts are in various stages. CMS and ONC continue to work in tandem
and with our stakeholders toward our shared goal of interoperability.
We encourage work by PDMPs, pharmacies, and health IT developers to use
existing and emerging open source standards to ensure greater
interoperability between PDMPs and health IT systems and within
efficient clinician workflows. The adoption and implementation of these
open source standards is important not only for PDMP query
functionality but for also other relevant tools, such as automated
clinical decision support, that facilitate more informed prescribing
practices and improved patient outcomes.
Comment: The commenter stated their state does not let the PDMP be
fully integrated with the electronic medical record. The commenter also
questioned how CMS envisions clinicians attesting to querying of the
PDMP, and it would be helpful to have more guidance from CMS.
Response: If you choose to submit data for CY 2019 for the Query of
PDMP measure, you will submit your numerator and denominator. We plan
to provide additional information in future rulemaking regarding this
measure in CY 2020 and beyond.
Comment: A commenter stated that some states are not planning for
EHR systems to interface with a PDMP and even those that are planning
for this functionality may face a lengthy process to develop the
ability for an EHR to integrate with a PDMP.
Response: We will use this input to help inform our future work and
ongoing collaborative efforts with our HHS colleagues, and with other
public- and private-sector partners, as appropriate. We will seek
comment and suggestions in future rulemaking to ascertain if additional
exclusions are needed for MIPS eligible clinicians located in one of
the States where PDMPs are not integrated with EHRs.
Comment: Some commenters supported the intent of this measure but
did not support the measure as written because it lacks standards.
Commenters suggested that CMS work with ONC to develop a national
standard for PDMPs.
Response: We will continue to collaborate with our colleagues
across HHS, and with other public-and private-sector partners as
appropriate.
Comment: A commenter addressed the impact the Query of PDMP measure
may have on patients who receive opioids due to medical diagnoses such
as cancer or receiving hospice. The commenter stated that patients with
cancer, in hospice care and/or end of life patients should be excluded
from this measure. The commenter also stated that CMS needed to do more
work to define ``cancer patient,'' and whether this included cancer
survivors or those with an active cancer diagnosis.
Response: We decline to add an exclusion for this for the 2019 MIPS
performance period because the measure is optional and not required. If
we propose to require this measure in future years, we may consider
this suggestion for an exclusion.
After consideration of the comments we received, we are finalizing
the Query of PDMP measure with modification:
Measure Description: For at least one Schedule II opioid
electronically prescribed using CEHRT during the performance period,
the MIPS eligible clinician uses data from CEHRT to conduct a query of
a PDMP for prescription drug history, except where prohibited and in
accordance with applicable law.
For the purposes of this measure, we are defining opioids as
Schedule II controlled substances under 21 CFR 1308.12. We are
finalizing the proposal to apply the same policies for the existing e-
Prescribing measure to the Query of PDMP measure, including the
requirement to use CEHRT as the sole means of creating the prescription
and for transmission to the pharmacy. The query of the PDMP for
prescription drug history must be conducted prior to the electronic
transmission of the Schedule II opioid prescription. MIPS eligible
clinicians would have flexibility to query the PDMP using CEHRT in any
manner allowed under their State law. This measure includes all
permissible prescriptions and dispensing of Schedule II opioids
regardless of the amount prescribed during an encounter in order for
MIPS eligible clinicians to identify multiple health care provider
episodes (physician shopping), prescriptions of dangerous combinations
of drugs, prescribing rates and controlled substances prescribed in
high quantities. To meet this measure, a MIPS eligible clinician must
use the capabilities and standards as defined for CEHRT at Sec. Sec.
170.315(a)(10)(ii) and (b)(3).
Denominator: Number of Schedule II opioids electronically
prescribed using CEHRT by the MIPS eligible clinician during the
performance period.
Numerator: The number of Schedule II opioid prescriptions in the
denominator for which data from CEHRT is used to conduct a query of a
PDMP for prescription drug history except where prohibited and in
accordance with applicable law. A numerator of at least one is required
to fulfill this measure.
As this measure is optional in CY 2019, we are not finalizing
exclusions for it. We will propose our policy for the Query of a PDMP
measure for CY 2020 in future rulemaking.
(B) Verify Opioid Treatment Agreement Measure
As we stated in the proposed rule at 83 FR 35923, the intent of
this measure is for MIPS eligible clinicians to identify whether there
is an existing opioid treatment agreement when they electronically
prescribe a Schedule II opioid using CEHRT if the total duration of the
patient's Schedule II opioid prescriptions is at least 30 cumulative
days. We stated that we believe seeking to identify an opioid treatment
agreement will further efforts to coordinate care between health care
providers and foster a more informed review of patient therapy. The
intent of the treatment agreement is to clearly outline the
responsibilities of both patient and MIPS eligible clinician in the
treatment plan. Such a treatment plan can be integrated into care
coordination and care plan activities

[[Page 59804]]

and documents as discussed and agreed upon by the patient and MIPS
eligible clinician. An opioid treatment agreement is intended to
support and to enable further coordination and the sharing of substance
use disorder (SUD) data with consent, as may be required of the
individual.
We stated that we understand from stakeholder feedback during
listening sessions that there are varied opinions regarding opioid
treatment agreements amongst health care providers. Some are supportive
of their use, indicating that treatment agreements are an important
part of the prescription of opioids for pain management, and help
patients understand their role and responsibilities for maintaining
compliance with terms of the treatment. Other health care providers
object to their use citing ethical concerns, and creation of division
and trust issues in the health care provider-patient relationship.
Other concerns stem from possible disconnect between the language and
terminology used in the agreement and the level of comprehension on the
part of the patient. Because of the debate among practitioners, we
requested comment on the challenges this proposed measure may create
for MIPS eligible clinicians, how those challenges might be mitigated,
and whether this measure should be included as part of the Promoting
Interoperability performance category. We also acknowledged challenges
related to prescribing practices and multiple State laws which may
present barriers to the uniform implementation of this proposed
measure. We solicited public comment on the challenges and concerns
associated with opioid treatment agreements and how they could impact
the feasibility of the proposal.
Proposed Measure Description: For at least one unique patient for
whom a Schedule II opioid was electronically prescribed by the MIPS
eligible clinician using CEHRT during the performance period, if the
total duration of the patient's Schedule II opioid prescriptions is at
least 30 cumulative days within a 6-month look-back period, the MIPS
eligible clinician seeks to identify the existence of a signed opioid
treatment agreement and incorporates it into the patient's electronic
health record using CEHRT.
We proposed this measure would include all Schedule II opioids
prescribed for a patient electronically using CEHRT by the MIPS
eligible clinician during the performance period, as well as any
Schedule II opioid prescriptions identified in the patient's medication
history request and response transactions during a 6-month look-back
period, where the total number of days for which a Schedule II opioid
was prescribed for the patient is at least 30 days.
We stated that there also may be MIPS eligible clinician burdens
specific to identifying the existence of a treatment agreement which
could require additional time and changes to existing workflows,
determining what constitutes a treatment agreement due to a lack of a
definition, standard or electronic format and manual calculation of the
measure. We note that there is no certified capability specific to
verification and incorporation of an opioid treatment agreement,
however, clinicians must use the capabilities and standards defined for
CEHRT at Sec. Sec. 170.315(a)(10) and (b)(3) and 170.205(b)(2) to meet
the measure. In addition, limitations in the completeness of care team
information may limit the ability of a MIPS eligible clinician to
identify all potential sources for querying and obtaining information
on a treatment agreement for a specific patient. There are currently
pilots in development focused on increasing connectivity and data
exchange among health care providers to better integrate behavioral
health information, for instance, pilots taking place as part of the
federal Demonstration Program for Certified Community Behavioral Health
Clinics (CCBHC) \27\ includes criteria on how CCBHCs should use health
IT to coordinate services and track data on quality measures.
Participants in such pilots would potentially have the means necessary
to leverage health IT connectivity to query behavioral health data
resources and health care providers within their region to identify the
existence of an opioid treatment agreement and to successfully
integrate patient information from the hospital stay into the care plan
for the patient. We solicited comment on other similar pathways to
facilitate the identification and exchange of treatment agreements and
opioid abuse treatment planning.
---------------------------------------------------------------------------

\27\ https://www.samhsa.gov/section-223.
---------------------------------------------------------------------------

We proposed the 6-month look-back period would begin on the date on
which the MIPS eligible clinician electronically transmits their
Schedule II opioid prescription using CEHRT and provided an
illustrative example of this policy in the proposed rule.
We proposed a 6-month look-back period to identify more egregious
cases of potential overutilization of opioids and to cover timeframes
for use outside the performance period. In addition, we proposed that
the 6-month look-back period would utilize at a minimum the industry
standard NCDCP SCRIPT v10.6 medication history request and response
transactions codified at Sec. 170.205(b)(2)). As ONC has stated (80 FR
62642), adoption of the requirements for NCDCP SCRIPT v10.6 does not
preclude developers from incorporating and using technology standards
or services not required by regulation in their health IT products.
We did not propose to define an opioid treatment agreement as a
standardized electronic document; nor did we propose to define the data
elements, content structure, or clinical purpose for a specific
document to be considered a ``treatment agreement.'' For this measure,
we solicited comment on what characteristics should be part of an
opioid treatment agreement including data, content and clinical purpose
into CEHRT, including which functionalities could be utilized to
accomplish this. We noted that a variety of standards available in
CEHRT might support the electronic exchange of opioid abuse related
treatment data, such as use of the Consolidated Clinical Document
Architecture (C-CDA) care plan template that is currently optional in
CEHRT.
We also solicited comment on methods or processes for incorporation
of the treatment agreement into CEHRT, including which functionalities
could be utilized to accomplish this task.
We solicited comment on whether there are specific data elements
that are currently standardized that should be incorporated via
reconciliation and if the ``patient health data capture'' functionality
(Sec. 170.315(e)(3)) could be used to incorporate a treatment plan
that is not a structured document with structured data elements.
Denominator: Number of unique patients for whom a Schedule II
opioid was electronically prescribed by the MIPS eligible clinician
using CEHRT during the performance period and the total duration of
Schedule II opioid prescriptions is at least 30 cumulative days as
identified in the patient's medication history request and response
transactions during a 6-month look-back period.
Numerator: The number of unique patients in the denominator for
whom the MIPS eligible clinician seeks to identify a signed opioid
treatment agreement and, if identified, incorporates the agreement in
CEHRT. A numerator of at least one is required to fulfill this measure.
Exclusion (beginning in 2020): Any MIPS eligible clinician who is
unable to electronically prescribe Schedule II opioids in accordance
with applicable law during the performance period.

[[Page 59805]]

We proposed that the exclusion criteria would be limited to
prescriptions of Schedule II opioids as the measure action is limited
to electronic prescriptions of Schedule II opioids only and does not
include any other types of electronic prescriptions.
We requested comment on the proposed exclusion criteria and whether
there are additional circumstances that should be added to the
exclusion criteria and what those circumstances might be including
medical diagnoses such as cancer or patients under care of hospice.
We solicited comment on whether these types of agreements could
create a burden on clinicians and patients, particularly clinicians who
serve patients with cancer or those practicing in hospice, as well as
the patients they serve.
We also proposed that, in order to meet this measure, a MIPS
eligible clinician must use the capabilities and standards as defined
for CEHRT at Sec. Sec. 170.315(a)(10) and (b)(3) and 170.205(b)(2).
As discussed earlier, we recognize that many health care providers
are only beginning to adopt electronic prescriptions for controlled
substances (EPCS) at this time. Although we have proposed two new
measures which combine EPCS with other actions, we requested comment on
whether stakeholders would be interested in a measure focused only on
the number of Schedule II opioids prescribed and the successful use of
EPCS for permissible prescriptions electronically prescribed.
We solicited comment about the feasibility of such a measure, and
whether stakeholders believe this would help to encourage broader
adoption of EPCS.
The following is a summary of the comments we received on these
proposals.
Comment: A few commenters supported the new Verify Opioid Treatment
Agreement measure, but stated concern about the amount of time
available for EHR vendors to update systems to meet the requirements of
the measure and request CMS give more lead-time for these type of
changes. Another commenter requested that CMS remove the requirement to
use the capabilities and standards of CEHRT to verify if an opioid
treatment agreement exists.
Response: We recognize the measure is technically complex and may
require updates to a MIPS eligible clinician's EHR systems in order to
effectively perform the functionality associated with this measure.
However, we believe there are MIPS eligible clinicians who are already
using health IT to verify whether there is an opioid treatment
agreement in place before electronically prescribing opioids. We also
believe it is important to continue to improve prescribing practices
for controlled substances using currently available methods as part of
existing workflow practices, and that this particular measure can help
lead to improvement in prescribing practices.
As discussed in the proposed rule, we believe there are some ways
in which certified health IT may be able to support the electronic
exchange of opioid related treatment data, such as use of the C-CDA
care plan template that is currently optional in CEHRT. This template
contains information on health concerns, goals, interventions, health
status evaluation & outcomes sections that could support the
development of an opioid treatment agreement. In addition, the
``patient health data capture'' functionality which is part of the 2015
Edition certification criteria (Sec. 170.315(e)(3)) could be used to
incorporate a treatment plan that is not a structured document with
structured data elements.
We note that there is no capability within certified health IT to
support verification of an opioid treatment agreement. We stated (83 FR
35925) that in order to meet the measure, MIPS eligible clinicians must
use the capabilities and standards defined for CEHRT at Sec. Sec.
170.315(a)(10) and (b)(3) and 170.205(b)(2). The certification criteria
defined at Sec. 170.315(a)(10) defines drug formulary checks and
preferred drug check lists for a given patient and medication, which
are the most useful when utilized with e-Prescribing. These criteria
may enable health IT to provide structured data to support querying and
may increase the efficiency and safety of opioid prescribing, while
potentially reducing the cost of care and confronting the opioid
crisis.
The certification criteria defined at Sec. 170.315(b)(3) supports
this measure because it allows a health care provider to create a new
prescription, change a prescription, cancel a prescription, refill a
prescription, request fill status notifications and request and receive
medication history information. Additionally, certification criteria
defined at Sec. 170.205(b)(2) adopts the NCPDP SCRIPT Standard v10.6
standards and associated implementation specifications for electronic
prescribing.
While we understand the above regulations do not specifically
define certification criteria and standards for the Verify Opioid
Treatment Agreement measure, we believe they may help provide a
framework for MIPS eligible clinicians who would like to implement the
measure.
Comment: Several commenters expressed concern regarding the
calculation of the denominator and potential data inaccuracies because
the data is from third party systems and the ability of the EHR to
calculate the performance rate is reliant on the quality of the data
received. The commenters stated there are no standards regarding the
type or format of data that is received. Therefore, the EHR system may
be incomplete, making the calculation inaccurate. The commenters
recommended that the Verify Opioid Treatment Agreement measure be
revised to acknowledge that the EHR will be able to calculate
prescription duration only with data supplied.
In addition, a commenter stated the measure is highly problematic
and prone to error calculation because the denominator is based on
patients who are receiving an electronic prescription for a Schedule II
opioid medication and have a total of 30 or more cumulative
prescription days on the Schedule II opioid being prescribed in a 6-
month look back period. The commenter stated that neither the NCPDP
10.6 Medication History Query nor the NCPDP 2017071 Medication History
Query has a required, discrete data field to capture the prescription
days. The commenter requested CMS not finalize the measure and not
proceed with making the measure optional until it can be better
defined. The commenter also stated that if the measure is finalized,
that CMS should change its denominator proposal to be based on doses
prescribed, as opposed to prescription days.
Response: We understand the measure would be technically complex
and potentially burdensome for MIPS eligible clinicians to implement
and that the results of the measure may be affected by data quality and
availability issues. We may consider modifications to the denominator
in future rulemaking.
In addition, as opioid treatment agreements become more widely
adopted, we believe this measure may help to encourage health IT
vendors to develop innovative solutions to capture data and reduce
workflow complexities.
Comment: A commenter requested clarification of the meaning of
``incorporates the agreement'' in CEHRT, as there are no standards
about what data elements are included in opioid treatment agreements.
The commenter also requested the numerator be changed to the number of

[[Page 59806]]

unique patients in the denominator for whom the MIPS eligible clinician
has a signed opioid treatment agreement in CEHRT.
Response: As we did not define standards, data elements, content
structure or clinical purpose for a specific document to be considered
an ``opioid treatment agreement,'' we also did not define what needs to
be incorporated into the CEHRT to meet the measure. Rather the intent
of an opioid treatment agreement is to support and enable further care
coordination and shared decision making. Therefore, we leave it to the
discretion of the MIPS eligible clinician to determine what is
considered an opioid treatment agreement and how to capture this in
their CEHRT.
We decline to change the numerator to those patients for whom the
MIPS eligible clinician has a signed opioid treatment agreement in
CEHRT. The goal of this measure is to encourage MIPS eligible
clinicians to seek to identify an existing opioid treatment agreement
for those patients for whom they have prescribed Schedule II opioids,
rather than those patients for whom they have successfully identified
and incorporated an opioid treatment agreement.
Comment: Many commenters suggested CMS align the requirements of
this measure with the similar measure for eligible hospitals and CAHs
under the Medicare Promoting Interoperability Program, so that the
Verify Opioid Treatment Agreement measure would be optional in the 2019
and 2020 MIPS performance periods.
Response: We appreciate the suggestion to align the requirements of
the Verify Opioid Treatment Agreement measure in the Promoting
Interoperability performance category with the Medicare Promoting
Interoperability Program for eligible hospitals and CAHs. CMS received
many similar concerns and feedback on the Verify Opioid Treatment
Agreement measure proposal for eligible hospitals and CAHs, which we
discussed in the FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20528
through 20530). The concerns noted by commenters on both the FY 2019
IPPS/LTCH PPS proposed rule and the CY 2019 PFS proposed rule included
the varied opinions on the effectiveness of opioid treatment
agreements, lack of specified certification standards and criteria, and
the complexities of implementing such a measure.
We understand these concerns and believe additional time is
necessary to implement this measure before we make it required.
Therefore, we are aligning with the Medicare Promoting Interoperability
Program for eligible hospitals and CAHs and making the Verify Opioid
Treatment Agreement measure optional for the 2019 and 2020 MIPS
performance periods. We will include proposals for this measure for
future years in future rulemaking.
Comment: Several commenters questioned whether MIPS eligible
clinicians who do not prescribe opioids are allowed to claim an
exclusion, or is the exclusion limited to those who cannot prescribe
opioids because of applicable law.
Response: We are not finalizing the Verify Opioid Treatment
Agreement measure as proposed and therefore are not finalizing the
exclusion we proposed at 83 FR 35925, which would have allowed any MIPS
eligible clinician who is unable to electronically prescribe Schedule
II opioids in accordance with applicable law during the performance
period to claim an exclusion.
Because we are finalizing the measure as optional for both the 2019
and 2020 performance periods, we decline to offer any additional
exclusions for this measure.
Comment: One commenter suggested that this measure overlaps with
existing quality and improvement activities and thus CMS should work to
allow MIPS eligible clinicians who report on measures and activities
under the quality and improvement activities performance categories to
automatically receive credit in the Promoting Interoperability
performance category.
Response: We appreciate the suggestion and are currently
considering possible ways that points could be earned across multiple
performance categories. We refer readers to our request for comment (83
FR 35932) where we requested input on ways to link these three
performance categories.
Comment: A commenter appreciated that the measure is intended to
verify whether an opioid treatment agreement exists, rather than
mandating the creation of an opioid treatment agreement.
Response: We believe it is important for MIPS eligible clinicians
to be able to use an existing opioid treatment agreement if one exists,
rather than creating a potentially duplicative agreement.
After consideration of the comments received, we are adopting our
proposal for the addition of the Verify Opioid Treatment Agreement
measure with modification:
Measure Description: For at least one unique patient for whom a
Schedule II opioid was electronically prescribed by the MIPS eligible
clinician using CEHRT during the performance period, if the total
duration of the patient's Schedule II opioid prescriptions is at least
30 cumulative days within a 6-month look-back period, the MIPS eligible
clinician seeks to identify the existence of a signed opioid treatment
agreement and incorporates it into the patient's electronic health
record using CEHRT.
We define opioids as Schedule II controlled substances under 21 CFR
1308.12. We are finalizing the proposal to apply the same policies for
the existing e-Prescribing measure to the Verify Opioid Treatment
Agreement measure, including the requirement to use CEHRT as the sole
means of creating the prescription and for transmission to the
pharmacy. This measure includes all Schedule II opioids prescribed for
a patient electronically using CEHRT by the MIPS eligible clinician
during the performance period, as well as any Schedule II opioid
prescriptions identified in the patient's medication history request
and response transactions during a 6-month look-back period, where the
total number of days for which a Schedule II opioid was prescribed for
the patient is at least 30 days.
The 6-month look-back period begins on the date on which the MIPS
eligible clinician electronically transmits their Schedule II opioid
prescription using CEHRT. The 6-month look-back period must utilize at
a minimum the industry standard NCDCP SCRIPT v10.6 medication history
request and response transactions codified at Sec. 170.205(b)(2)).
To meet this measure, a MIPS eligible clinician must use the
capabilities and standards as defined for CEHRT at Sec. Sec.
170.315(a)(10) and (b)(3) and 170.205(b)(2).
Denominator: Number of unique patients for whom a Schedule II
opioid was electronically prescribed by the MIPS eligible clinician
using CEHRT during the performance period and the total duration of
Schedule II opioid prescriptions is at least 30 cumulative days as
identified in the patient's medication history request and response
transactions during a 6-month look-back period.
Numerator: The number of unique patients in the denominator for
whom the MIPS eligible clinician seeks to identify a signed opioid
treatment agreement and, if identified, incorporates the agreement in
CEHRT. A numerator of at least one is required to fulfill this measure.
This measure will be optional in the CY 2019 and 2020 performance
periods, so we are not finalizing the proposed exclusion for CY 2020.

[[Page 59807]]

(iii) Measures for the Health Information Exchange Objective
As we stated in the proposed rule (83 FR 35925) the Health
Information Exchange measures for MIPS eligible clinicians hold
particular importance because of the role they play within the care
continuum. In addition, these measures encourage and leverage
interoperability on a broader scale and promote health IT-based care
coordination. However, through our review of the existing measures, we
determined that we could potentially improve the measures to further
reduce burden and better focus the measures on interoperability in
health care provider to health care provider exchange. Such
modifications would address a number of concerns raised by stakeholders
including:
Supporting the implementation of effective health IT
supported workflows based on a specific organization's needs;
Reducing complexity and burden associated with the manual
tracking of workflows to support health IT measures; and
Emphasizing within these measures the importance of using
health IT to support closing the referral loop to improve care
coordination.
We stated that we believe we can potentially improve the existing
Health Information Exchange measures to streamline measurement, remove
redundancy, reduce complexity and burden, and address stakeholders'
concerns about the focus and impact of the measures on the
interoperable use of health IT.
In the CY 2019 PFS proposed rule (83 FR 35925 through 35928), we
proposed several changes to the current measures under the Health
Information Exchange objective. First, we proposed to change the name
of the Send a Summary of Care measure to Support Electronic Referral
Loops by Sending Health Information. We also proposed to remove the
Clinical Information Reconciliation measure and combine it with the
Request/Accept Summary of Care measure to create a new measure, Support
Electronic Referral Loops by Receiving and Incorporating Health
Information. This proposed new measure would include actions from both
the Request/Accept Summary of Care measure and Clinical Information
Reconciliation measure.
(A) Modifications to the Send a Summary of Care Measure
We proposed to change the name of the Send a Summary of Care
measure to Support Electronic Referral Loops by Sending Health
Information measure (83 FR 35925 through 35926), to better reflect the
emphasis on completing the referral loop and improving care
coordination.
Through public comment and stakeholder correspondence, we have
become aware that in the health care industry there is some
misunderstanding of the scope of transitions and referrals which must
be included in the denominator of this measure. In the event that a
MIPS eligible clinician is the recipient of a transition of care or
referral, and subsequent to providing care the MIPS eligible clinician
transitions or refers the patient back to the referring provider of
care, this transition of care should be included in the denominator of
the measure for the MIPS eligible clinician. We expect this will help
build upon the current provider to provider communication via
electronic exchange of summary of care records created by CEHRT
required under this measure, further promote interoperability and care
coordination with additional health care providers, and prevent
redundancy in creation of a separate measure.
In the past, stakeholders have raised concerns that the summary
care records shared according to the C-CDA standard included excessive
information not relevant to immediate care needs, which increased
burden on health care providers. Under the ONC Health IT Certification
Program 2015 Edition, CEHRT must have the capability to exchange all of
the information in the CCDS as part of a summary care record structured
according to the C-CDA standard. We previously finalized in the final
rule titled ``Medicare and Medicaid Programs Electronic Health Record
Incentive Program--Stage 2: Health Information Technology, Standards
Implementation Specifications, and Certification Criteria for
Electronic Health Record Technology, 2014 Edition; Revisions to the
Permanent Certification Program for Health Information Technology''
(hereafter referred to as the ``Stage 2 final rule'') (77 FR 53991
through 53993) that health care providers must transmit all of the CCDS
information as part of this summary care record, if known, and that
health care providers must always transmit information about the
problem list, medications, and medication allergies, or validate that
this information is not known.
As finalized in the final rule titled ``Medicare and Medicaid
Programs; Electronic Health Record Incentive Program--Stage 3 and
Modifications to Meaningful Use in 2015 Through 2017; Final Rule''
(hereafter referred to as the ``2015 EHR Incentive Programs final
rule'') (80 FR 62852 through 62861), our policy allows health care
providers to constrain the information in the summary care record to
support transitions of care. For instance, we encouraged health care
providers to send a list of items that he or she believes to be
pertinent and relevant to the patient's care, rather than a list of all
problems, whether active or resolved, that have ever populated the
problem list. Although a current problem list must always be included,
the health care provider can use his or her judgment in deciding which
items historically present on the problem list, medical history list
(if it exists in CEHRT), or surgical history list are relevant given
the clinical circumstances.
We also wish to encourage MIPS eligible clinicians to use the
document template available within the C-CDA which contains the most
clinically relevant information required by the receiver. Accordingly,
we proposed that MIPS eligible clinicians may use any document template
within the C-CDA standard for purposes of the measures under the Health
Information Exchange objective. Although a MIPS eligible clinician's
CEHRT must be capable of sending the full C-CDA upon request, we
believe this additional flexibility will help support clinicians'
efforts to ensure the information supporting a transition is relevant.
For instance, when the MIPS eligible clinician is referring to
another health care provider the recommended document is the ``Referral
Note'' which is designed to communicate pertinent information from a
MIPS eligible clinician who is requesting services of another health
care provider of clinical or non-clinical services. When the receiving
health care provider sends back the information, the most relevant C-
CDA document template may be the ``Consultation Note,'' which is
generated by a request from a clinician for an opinion or advice from
another clinician. Although the 2015 Edition transition of care
certification criterion only requires testing to the Continuity of Care
Document and Referral Note document templates, we proposed to allow
MIPS eligible clinicians the flexibility to use additional C-CDA
templates most appropriate to their clinical workflows. Clinicians
would need to work with their health IT developer to determine
appropriate technical workflows and implementation. For more
information about the C-CDA and associated templates, see https://
www.hl7.org/documentcenter/public/standards/dstu/

[[Page 59808]]

CDAR2_IG_CCDA_CLINNOTES_R1_DSTUR2.1_2015AUG.zip.
The following is a summary of the comments we received on these
proposals.
Comment: A commenter stated that renaming the measure creates too
much confusion and inconvenience because there are too many MIPS
eligible clinicians and locations per clinician to keep track of, which
undermines the quality of care provided to patients. Other commenters
stated that MIPS eligible clinicians are accustomed to the current name
and changing the name will only contribute to confusion.
Response: We respectfully decline to retain the current name as we
believe that the proposed new name, Support Electronic Referral Loops
by Sending Health Information measure, better reflects the emphasis on
completing the referral loop and improving care coordination. We also
believe that it is important to align measure names across the Medicare
Promoting Interoperability Program and the Promoting Interoperability
performance category to reduce confusion and burden for health care
providers.
Comment: A commenter requested that this measure be modified or
removed from the Promoting Interoperability performance category
because there is a limited number of specialists that are able to
receive the summary of care.
Response: While we understand that there may be challenges
associated with this measure, we believe that the sharing of health
information with other health care providers treating patients is
imperative to improving the quality of care. While we understand that
some specialists may be lagging behind in their adoption of CEHRT, the
numbers of specialists using CEHRT continues to rise over time. We
continue to believe that the use of paper records will continue to
diminish and that use of CEHRT will continue to increase. Including
this measure as a requirement of the Promoting Interoperability
performance category will incentivize clinicians to electronically
share the summary of care.
Comment: One commenter addressed our proposal to allow MIPS
eligible clinicians to use any document template within the C-CDA for
the measures associated with this objective and requested that CMS not
expect clinicians to manually select C-CDA templates or portions of
templates when sending documents because it adds workflow steps and
interferes with solutions that automate sending of information. The
commenter recommended that CMS investigate the Integrated Healthcare
Enterprise (IHE) summary sections profile for potential future
adoption. Other commenters supported allowing MIPS eligible clinicians
and groups to determine which data is most appropriate to be shared.
Response: We believe that this additional flexibility allowing MIPS
eligible clinicians to use any document template within the C-CDA will
help support MIPS eligible clinicians efforts to ensure the information
supporting a transition of care is relevant and note that the use of
any additional template would be optional for MIPS eligible clinicians.
Although MIPS eligible clinicians must have the capability to send the
full CCDA upon request, they may choose to send just the items that are
pertinent and relevant to the patient's care. The ability to select the
most appropriate template will enable the most clinically relevant
information to be transmitted. We will work with ONC to consider other
suggestions regarding the adoption of other health IT standards and may
consider the suggestion to include the IHE summary sections profile in
future rulemaking.
Comment: A few commenters requested that CMS allow for flexibility
to use any C-CDA formats available to meet the HIE measures to create
and electronically send summary of care records.
Response: We believe the proposal to allow MIPS eligible clinicians
to use any document template within the C-CDA will provide further
flexibility for health care providers to focus on clinically relevant
information. We note that CEHRT supports the ability to send and
receive C-CDA documents according to Releases 1.1 and 2.1 to support
interoperability and exchange. The 2015 Edition transitions of care
certification criterion at Sec. 170.315(b)(1) requires Health IT
Modules to support the Continuity of Care Document, Referral Note, and
(inpatient settings only) Discharge Summary document templates.
While MIPS eligible clinicians' CEHRT must be capable of sending
the full C-CDA upon request, we believe this additional flexibility to
utilize different functionality within the C-CDA will help support
clinicians efforts to ensure the information supporting a transition is
relevant. We note that in the use of a document template the clinician
would need to work with their developer to determine appropriate
technical workflows and implementation.
Comment: Some commenters supported allowing MIPS eligible
clinicians and groups to determine which data is most appropriate to be
shared. A few commenters agreed with use of any C-CDA document
templates available within the C-CDA which contains the most clinically
relevant information that may be required by the recipient of the
transition or referral. The commenters stated this proposal supports
increased flexibility, enables increased information sharing between
care providers, and will help providers better understand their
patient's history.
Response: We appreciate the feedback by the commenter and agree
that this proposal will provide further flexibility for health care
providers to focus on clinically relevant information and decrease
burden associated with reporting requirements.
Comment: Commenters questioned whether there was an exclusion for
the Support Electronic Referral Loops by Sending Health Information
measure. A few commenters stated that the lack of an exclusion will
unfairly disadvantage MIPS eligible clinicians and practices that are
unable to send at least one received summary of care.
Response: While we proposed to change the name of the Send a
Summary of Care measure, we did not propose changes to the numerator,
denominator or exclusion for the measure. The exclusion remains for
this measure.
Exclusion: Any MIPS eligible clinician who transfers a patient to
another setting or refers a patient fewer than 100 times during the
performance period.
After consideration of the comments received, we are finalizing the
proposal to change the name of the Send a Summary of Care measure to
Support Electronic Referral Loops by Sending Health Information
measure. We are also finalizing the proposal that MIPS eligible
clinicians may use any document template within the C-CDA standard for
purposes of the measures under the Health Information Exchange
objective.
(B) Removal of the Request/Accept Summary of Care Measure
We proposed to remove the Request/Accept Summary of Care measure
(83 FR 35926) based on our analysis of the existing measure and in
response to stakeholder input.
We stated that, through review of implementation practices based on
stakeholder feedback, we believe that the existing Request/Accept
Summary of Care measure is not feasible for machine calculation in the
majority of cases. The intent of the measure is to identify when MIPS
eligible clinicians are engaging with other providers of

[[Page 59809]]

care or care team members to obtain up-to-date patient health
information and to subsequently incorporate relevant data into the
patient record. However, stakeholders have noted the measure
specification does not effectively further this purpose. Specifically,
the existing measure specification results in unintended consequences
where health care providers implement either:
(1) A burdensome workflow to document the manual action to request
or obtain an electronic record, for example, clicking a check box to
document each phone call or similar manual administrative task, or
(2) A workflow which is limited to only querying internal resources
for the existence of an electronic document.
Neither of these two implementation options is desirable when the
intent of the measure is to incentivize and encourage health care
providers to implement effective workflows to identify, receive, and
incorporate patient health information from other health care providers
into the patient record.
In addition, our analysis identified that the definition of
incorporate within the Request/Accept Summary of Care measure is
insufficient to ensure an interoperable result. When this measure was
initially finalized in the 2015 EHR Incentive Programs final rule at 80
FR 62860, we did not define ``incorporate'' as we believed it would
vary amongst health care provider's workflows, patient population and
the referring health care provider. In addition, we noted that the
information could be included as an attachment, as a link within the
EHR, as imported structured data or reconciled within the record and
not exclusively performed through use of CEHRT. Further, stakeholder
feedback highlights the fact that the requirement to incorporate data
is insufficiently clear regarding what data must be incorporated.
Our intention was that ``incorporate'' would relate to the
workflows undertaken in the process of clinical information
reconciliation further defined in the Clinical Information
Reconciliation measure (80 FR 62852 through 62862). Taken together, the
three measures under the Health Information Exchange objective were
intended to support the referral loop through sending, receiving, and
incorporating patient health data into the patient record. However,
stakeholder feedback on the measures suggests that the separation
between receiving and reconciling patient health information is not
reflective of clinical and care coordination workflows. Further,
stakeholders noted, that when approached separately, the incorporate
portion of the Request/Accept Summary of Care measure is both
inconsistent with and redundant to the Clinical Information
Reconciliation measure which causes unnecessary burden and duplicative
measure calculation.
The following is a summary of the comments we received on these
proposals.
Comment: Commenters supported the removal of this measure, and
stated they appreciated CMS' acknowledgement of the challenges of the
current Request/Accept Summary of Care measure.
Response: We believe that removing the measure will reduce burden.
Comment: One commenter stated that it is confusing for CMS to state
in the proposed rule that measures will be removed, when they are truly
just re-named. The commenter stated that the Request/Accept Summary of
Care measure and the Clinical Information Reconciliation measure would
not be removed. Rather, they would be combined into a new measure named
Support Electronic Referral Loops by Receiving and Incorporating Health
Information.
Response: While we appreciate this comment, the result of our
proposals would be to replace two measures with one measure, resulting
in a reduction in the number of measures.
Comment: A commenter requested that CMS maintain the current
separate Request/Accept Summary of Care and Clinical Information
Reconciliation measures instead of replacing them with the combined
measure because MIPS eligible clinicians understand the separate
measures.
Response: We disagree and believe that reducing the number of
measures reduces burden for MIPS eligible clinicians. Also the proposed
measures, Support Electronic Referral Loops by Sending Health
Information and Support Electronic Referral Loops by Receiving and
Incorporating Health Information, align with our focus on the exchange
of health care information and aligns with the measures for the
Medicare Promoting Interoperability Program.
After consideration of the comments received, we are removing the
Request/Accept Summary of Care Measure as proposed.
(C) Removal of the Clinical Information Reconciliation Measure
We proposed to remove the Clinical Information Reconciliation
measure (83 FR 35927) to reduce redundancy, complexity, and MIPS
eligible clinician burden.
We stated that we believe the Clinical Information Reconciliation
measure is redundant in regard to the requirement to ``incorporate''
electronic summaries of care in light of the requirements of the
Request/Accept Summary of Care measure. In addition, the measure is not
fully health IT based as the exchange of health care information is not
required to complete the measure action and the measure specification
is not limited to only the reconciliation of electronic information in
health IT supported workflows. We stated in the 2015 EHR Incentive
Programs final rule at 80 FR 62861 that the clinical information
reconciliation process could involve both automated and manual
reconciliation to allow the receiving health care provider to work with
both electronic data received as well as the patient to reconcile their
health information. Further, stakeholder feedback from hospitals,
clinicians, and health IT developers indicates that because the measure
is not fully based on the use of health IT to meet the measurement
requirements, health care providers must engage in burdensome tracking
of manual workflows. While the overall activity of clinical information
reconciliation supports quality patient care and should be a part of
effective clinical workflows, the process to record and track each
individual action places unnecessary burden on MIPS eligible
clinicians.
The following is a summary of the comments we received on these
proposals.
Comment: Commenters supported the removal of the Clinical
Information Reconciliation measure and its incorporation with the
Request/Accept Summary of Care measure. Some commenters stated that
removal of the Clinical Information Reconciliation measure would reduce
burden.
Response: We appreciate the support for our proposal and agree that
it will reduce burden.
After consideration of the comments received, we are removing the
Clinical Information Reconciliation measure as proposed.
(D) Support Electronic Referral Loops by Receiving and Incorporating
Health Information Measure
We proposed to add the following new measure for inclusion in the
Health Information Exchange objective: Support Electronic Referral
Loops by Receiving and Incorporating Health Information (FR 83 35927).
This measure would build upon and replace the existing Request/Accept
Summary of Care and Clinical Information Reconciliation measures.

[[Page 59810]]

Proposed name of measure and description: Support Electronic
Referral Loops by Receiving and Incorporating Health Information: For
at least one electronic summary of care record received for patient
encounters during the performance period for which a MIPS eligible
clinician was the receiving party of a transition of care or referral,
or for patient encounters during the performance period in which the
MIPS eligible clinician has never before encountered the patient, the
MIPS eligible clinician conducts clinical information reconciliation
for medication, medication allergy, and current problem list.
We proposed to combine two existing measures, the Request/Accept
Summary of Care measure and the Clinical Information Reconciliation
measure, in this new Support Electronic Referral Loops by Receiving and
Incorporating Health Information measure to focus on the exchange of
health care information as the current Clinical Information
Reconciliation measure is not reliant on the exchange of health care
information to complete the measure action. We did not propose to
change the actions associated with the existing measures; rather, we
proposed to combine the two measures to focus on the exchange of the
health care information, reduce administrative burden, and streamline
and simplify reporting.
CMS and ONC worked together to define the following for this
measure:
Denominator: Number of electronic summary of care records received
using CEHRT for patient encounters during the performance period for
which a MIPS eligible clinician was the receiving party of a transition
of care or referral, and for patient encounters during the performance
period in which the MIPS eligible clinician has never before
encountered the patient.
Numerator: The number of electronic summary of care records in the
denominator for which clinical information reconciliation is completed
using CEHRT for the following three clinical information sets: (1)
Medication--Review of the patient's medication, including the name,
dosage, frequency, and route of each medication; (2) Medication
allergy--Review of the patient's known medication allergies; and (3)
Current Problem List--Review of the patient's current and active
diagnoses.
Exclusions: (1) Any MIPS eligible clinician who is unable to
implement the measure for a MIPS performance period in 2019 would be
excluded from this measure. (2) Any MIPS eligible clinician who
receives fewer than 100 transitions of care or referrals or has fewer
than 100 encounters with patients never before encountered during the
performance period would be excluded from this measure.
We note that these two exclusions for the measure were proposed in
different sections of the proposed rule (83 FR 35916, 35927).
We requested comment on the proposed exclusion criteria and whether
there are additional circumstances that should be added to the
exclusion criteria and what those circumstances might be.
For the proposed measure, the denominator would increment on the
receipt of an electronic summary of care record after the MIPS eligible
clinician engages in workflows to obtain an electronic summary of care
record for a transition, referral or patient encounter in which the
MIPS eligible clinician has never before encountered the patient. The
numerator would increment upon completion of clinical information
reconciliation of the electronic summary of care record for
medications, medication allergies, and current problems. The MIPS
eligible clinician would no longer be required to manually count each
individual non-health-IT-related action taken to engage with other
providers of care and care team members to identify and obtain the
electronic summary of care record. Instead, the proposed measure would
focus on the result of these actions when an electronic summary of care
record is successfully identified, received, and reconciled with the
patient record. We stated that we believe this approach would allow
MIPS eligible clinicians to determine and implement appropriate
workflows supporting efforts to receive the electronic summary of care
record consistent with the implementation of effective health IT
information exchange at an organizational level.
Finally, we proposed to apply our existing policy for cases in
which the MIPS eligible clinician determines no update or modification
is necessary within the patient record based on the electronic clinical
information received, and the MIPS eligible clinician may count the
reconciliation in the numerator without completing a redundant or
duplicate update to the record. We welcomed public comment on methods
by which this specific action could potentially be electronically
measured by the MIPS eligible clinician's health IT system--such as
incrementing on electronic signature or approval by an authorized
health care provider--to mitigate the risk of burden associated with
manual tracking of the action, such as having to click check boxes.
We welcomed public comment on these proposals. We solicited comment
on methods and approaches to quantify the reduction in burden for MIPS
eligible clinicians implementing streamlined workflows for this
proposed health IT-based measure. We also solicited comment on the
impact these proposed modifications may have for health IT developers
in updating, testing, and implementing new measure calculations related
to these proposed changes. Specifically, we solicited comment on
whether ONC should require developers to recertify their EHR technology
as a result of the changes proposed, or whether they should be able to
make the changes and engage in testing without recertification, and on
the appropriate timeline for such requirements factoring in the
proposed continuous 90 day performance period within the calendar year
for clinicians. Finally, we solicited comment on whether this proposed
new measure that combines the Request/Accept Summary of Care and
Clinical Information Reconciliation measures should be adopted, or
whether either or both of the existing Request/Accept Summary of Care
and Clinical Information Reconciliation measures should be retained in
lieu of this proposed new measure.
We stated that in the event we finalize the new scoring methodology
we proposed in section III.H.3.h.(5)(d) of the proposed rule, an
exclusion would be available for MIPS eligible clinicians who cannot
implement the Support Electronic Referral Loops by Receiving and
Incorporating Health Information measure for a performance period in CY
2019 and an exclusion for MIPS eligible clinician who receives fewer
than 100 transitions of care or referrals or has fewer than 100
encounters with patients never before encountered during the
performance period.
We also proposed that, in order to meet this measure, a MIPS
eligible clinician must use the capabilities and standards as defined
for CEHRT at Sec. 170.315(b)(1) and (2).
We solicited comment on these proposals and our summary and
response are below.
Comment: A commenter stated that the incorporation of clinical
information within the C-CDA into the receiving clinician's CEHRT is
limited by the CEHRT and not the clinician. The commenter recommended
that the measure be eliminated and requested that CMS work with ONC to
strengthen interoperability requirements.

[[Page 59811]]

Response: We are working with ONC to explore and potentially
implement many initiatives to strengthen interoperability. We
understand that there may be limitations with 2015 CEHRT but we believe
that EHR developers and vendors will update their products so the CEHRT
will calculate the combined measure and not further burden the MIPS
eligible clinician.
Comment: Many commenters supported the proposal to combine the
Clinical Information Reconciliation measure with the Request/Accept
Summary of Care measure into the proposed Support Electronic Referral
Loops by Receiving and Incorporating Health Information measure. Some
commenters agreed that the proposed measure will allow MIPS eligible
clinicians to focus on the exchange of health care information and
reconcile the data in patients' medical records.
Response: We appreciate the commenter's support for efforts to
improve processes and technology solutions around closing referral
loops. We believe that the combined measure focuses on the exchange of
health care information and reduces administrative burden. We also
believe that this measure will help incentivize further innovation
around interoperable exchange of information to support these
processes.
Comment: Some commenters disagreed with our proposal to combine the
Clinical Information Reconciliation measure with the Request/Accept
Summary of Care measure stating that clinical information
reconciliation is important and it should remain a stand-alone measure.
They indicated that combining the Clinical Information Reconciliation
measure with another measure diminishes its importance. Other
commenters stated that combining these measures into one is onerous for
both front line staff responsible for running reports, as well as EHR
developers and clinicians hoping to improve scores, since they will not
fully know which measure to target. Some commenters stated that the
name change is extremely confusing. Other commenters stated that this
new measure is more burdensome and it will be harder to specifically
target issues within the measure because two workflows will be
combined.
Response: We believe that the current separation of the measures is
burdensome and redundant in the action of incorporation of the summary
of care record. In addition, we listened to stakeholder' concerns
regarding the separate Request/Accept Summary of Care and Clinical
Information Reconciliation measures, which indicated that the
separation between receiving and reconciling patient health information
is not reflective of clinical and care coordination workflows and the
incorporation aspect is redundant to both measures. We agree the
process of clinical information reconciliation includes both automated
and manual reconciliation to allow the receiving health care provider
to work with both the electronic data provided with any necessary
review, and to work directly with the patient to reconcile their health
information. In addition, we believe that combining the measures of
Request/Accept Summary of Care and Clinical Information Reconciliation
retains the focus on interoperability and exchange of health
information as opposed to the separation of the measures where health
information exchange and interoperability was not a focus for clinical
information reconciliation.
Comment: One commenter noted the measure exclusion (Any MIPS
eligible clinician who receives fewer than 100 transitions of care or
referrals or has fewer than 100 encounters with patients never before
encountered during the performance period) is causing greater hardship
for those clinicians that refer out more than 100 times and therefore
must report this measure. While most primary care clinicians refer out
more than 100 times in a 90-day period, many specialists do not. If a
specialist can claim an exclusion, and therefore, not set up direct
messaging capabilities, it may affect the performance on the measure of
clinicians that are referring to those specialists if they cannot find
someone they refer to that has the capability.
Response: The use of direct messaging is not required to fulfill
this measure. Our intent has been to promote and facilitate a wide
range of options for the transmission of an electronic summary of care
document. Examples of acceptable transmission methods include secure
email, Health Information Service Provider (HISP), query-based exchange
or use of third party HIE.
Comment: Commenters supported the exclusions for Support Electronic
Referrals Loops by Receiving and Incorporating Health Information.
Response: We appreciate the support and believe the exclusions will
benefit MIPS eligible clinicians who are unable to implement the
measure because they do not refer or transition patients or because
they cannot implement the measure for the 2019 MIPS performance period.
After consideration of the public comments we received, we are
finalizing the Support Electronic Referral Loops by Receiving and
Incorporating Health Information measure as proposed. We are finalizing
the proposal to apply the existing policy for cases in which the MIPS
eligible clinician determines no update or modification is necessary
within the patient record based on the electronic clinical information
received, and the MIPS eligible clinician may count the reconciliation
in the numerator without completing a redundant or duplicate update to
the record.
We are finalizing a MIPS eligible clinician must use the
capabilities and standards as defined for CEHRT at Sec. 170.315(b)(1)
and (b)(2).
We are adopting the Support Electronic Referral Loops by Receiving
and Incorporating Health Information measure as follows:
Measure Description: Support Electronic Referral Loops by
Receiving and Incorporating Health Information: For at least one
electronic summary of care record received for patient encounters
during the performance period for which a MIPS eligible clinician was
the receiving party of a transition of care or referral, or for patient
encounters during the performance period in which the MIPS eligible
clinician has never before encountered the patient, the MIPS eligible
clinician conducts clinical information reconciliation for medication,
mediation allergy, and current problem list.
Denominator: Number of electronic summary of care records received
using CEHRT for patient encounters during the performance period for
which a MIPS eligible clinician was the receiving party of a transition
of care or referral, and for patient encounters during the performance
period in which the MIPS eligible clinician has never before
encountered the patient.
Numerator: The number of electronic summary of care records in the
denominator for which clinical information reconciliation is completed
using CEHRT for the following three clinical information sets: (1)
Medication--Review of the patient's medication, including the name,
dosage, frequency, and route of each medication; (2) Medication
allergy--Review of the patient's known medication allergies; and (3)
Current Problem List--Review of the patient's current and active
diagnoses.
Exclusions: (1) Any MIPS eligible clinician who is unable to
implement the measure for a MIPS performance period in 2019 would be
excluded from this measure.

[[Page 59812]]

(2) Any MIPS eligible clinician who receives fewer than 100
transitions of care or referrals or has fewer than 100 encounters with
patients never before encountered during the performance period.
(iv) Measures for the Provider to Patient Exchange Objective
The Provider to Patient Exchange objective for MIPS eligible
clinicians builds upon the goal of improved access and exchange of
patient data, patient centered communication and coordination of care
using CEHRT. We proposed a new scoring methodology in section
III.H.3.h.(5)(d) of the proposed rule, under which we proposed to
rename the Patient Electronic Access objective to Provider to Patient
Exchange, remove the Patient-Specific Education measure and rename the
Provide Patient Access measure to Provide Patients Electronic Access to
Their Health Information. In addition, we proposed to remove the
Coordination of Care through Patient Engagement objective and all
associated measures. The existing Promoting Interoperability
performance category Patient Electronic Access objective includes two
measures and the existing Coordination of Care through Patient
Engagement objective includes three measures.
We reviewed the Promoting Interoperability performance category
requirements and determined that these proposals could reduce program
complexity and burden and better focus on leveraging the most current
health IT functions and standards for patient flexibility of access and
exchange of information.
In the CY 2019 PFS proposed rule (83 FR 35928 through 35929), we
proposed the Provider to Patient Exchange objective would include one
measure, the existing Provide Patient Access measure, which we proposed
to rename to Provide Patients Electronic Access to Their Health
Information.
(A) Modifications To Provide Patient Access Measure
We proposed to change the name of the Provide Patient Access
measure to Provide Patients Electronic Access to Their Health
Information measure (83 FR 35928) to better reflect the emphasis on
patient engagement in their health care and patient's electronic access
of their health information through use of APIs.
We proposed to change the measure name to emphasize electronic
access of patient health information as opposed to use of paper-based
actions and limit the focus to only health IT solutions to encourage
adoption and innovation in use of CEHRT (80 FR 62783 through 62784). In
addition, we are committed to promoting patient engagement with their
healthcare information and ensuring access in an electronic format.
We solicited comment on these proposals and our summary and
response are below.
Comment: A commenter supported the new name for the measure but
recommended that CMS not require widespread use of APIs for at least 3
years after the final standard for the measure has been published.
Response: We decline to provide additional time to implement this
measure. In the 2015 Edition final rule, ONC finalized certification
criteria that will enable clinicians using 2015 Edition CEHRT to share
information through an API consistent with the requirements of this
measure (80 FR 62675). As discussed, we believe that eligible
clinicians have already implemented, or are prepared to implement, this
functionality as part of the 2015 Edition of CEHRT for 2019 and will be
able to fulfill this measure.
Comment: One commenter recommended that CMS establish an exclusion
for this measure if the MIPS eligible clinician cannot successfully
identify an application that meets their security needs. Another
requested an exclusion if the MIPS eligible clinician's EHR does not
have the ability to have a portal. A commenter cautioned that CMS must
address the risks that this measure poses for systems security and the
confidentiality of health information because of its use of APIs and
recommended that CMS provide an exclusion for this measure for MIPS
eligible clinicians that cannot successfully identify an application
that meets their security needs. The commenter also recommended that
CMS work with the OCR and the FTC to develop an extensive education
program so that consumers can be aware of how application companies may
use their data.
Response: We decline to implement exclusion criteria for the
Provide Patients Electronic Access to Their Health Information measure
as we believe MIPS eligible clinicians should work with their health IT
vendors to identify applications that meet their security needs. While
we appreciate stakeholder concerns regarding security issues, we
believe there are already applications available to consumers that
could satisfy security requirements. The 2015 Edition of CEHRT enables
clinicians to provide patients with timely access to their health
information and make the patient's health information available for the
patient (or patient authorized representative) to access using any
application of their choice that is configured to meet the technical
specifications of the application programming interfaces (API) in the
MIPS eligible clinician's CEHRT.
We appreciate commenters' interest in additional educational
materials for patients on how they can improve the privacy and security
of their health information. We will take this comment into
consideration as we consider what other consumer-facing materials are
helpful, and we direct commenters to resources currently available from
HHS (for example, content and materials such as those available at
https://www.hhs.gov/hipaa/for-individuals/right-to-access/)
and FTC (for example, content and materials such as those available at
https://www.consumer.ftc.gov/topics/online-security) websites.
Comment: A few commenters requested that CMS confirm that this
measure focuses on MIPS eligible clinicians making the information
available to patients and does not account for patient use.
Response: The Provide Patients Electronic Access to Their Health
Information measure does not require that patients actually access
their information. Patients should be able to access their health
information on demand, and we encourage MIPS eligible clinicians to
maintain the appropriate functionalities for patient access to their
health information at all times unless the system is undergoing
scheduled maintenance, which should be limited.
Comment: A commenter stated that changing the names of measures
with essentially the same meaning is confusing to MIPS eligible
clinicians. The Provide Patients Electronic Access to Their Health
Information measure should simply be called the Provide Patients
Electronic Access measure.
Response: We did not intend to confuse MIPS eligible clinicians. We
believe that the name change effectively focuses the electronic aspect
of the measure and our focus on leveraging advanced use of HIT. We also
believe it is important to align the names of the measures of the
Promoting Interoperability performance category with the Medicare
Promoting Interoperability Program for eligible hospitals and CAHs.
Many health care providers have noted frustration with the differing
requirements between the two programs and we believe that through
alignment we can reduce much of that frustration.

[[Page 59813]]

After consideration of the comments we received, we finalizing the
new name, Provide Patients Electronic Access to Their Health
Information, as proposed.
(B) Removal of the Patient-Generated Health Data Measure
We proposed to remove the Patient-Generated Health Data (PGHD)
measure (83 FR 35928) to reduce complexity and focus on the goal of
using advanced EHR technology and functionalities to advance
interoperability and health information exchange.
As finalized in the 2015 EHR Incentive Programs final rule at 80 FR
62851, the measure is not fully health IT based as we did not specify
the manner in which health care providers would incorporate the data
received. Instead, we finalized that health care providers could work
with their EHR developers to establish the methods and processes that
work best for their practice and needs. We indicated that this could
include incorporation of the information using a structured format
(such as an existing field in the EHR or maintaining an isolation
between the data and the patient record such as incorporation as an
attachment, link or text reference which would not require the advanced
use of CEHRT). Although we continue to believe that incorporating this
data is valuable, we prioritized only those actions which are completed
electronically using certified health IT.
We solicited comment on these proposals and our summary and
response are below.
Comment: Several commenters disagreed with our proposal to remove
this measure as it is essential for encouraging the collection and use
of patient-reported outcomes. The commenters urged CMS to retain this
measure to encourage MIPS eligible clinicians to establish workflows to
collect and integrate these critical data into their medical records,
thereby promoting interoperability and patient-centered care. One
commenter stated that the removal of this measure signals that patient
and caregiver engagement has taken a backseat to provider to provider
care coordination. Another stated that the measure is crucial for
healthcare to be truly interoperable and person-centered.
Response: Functions and standards related to measures that are no
longer required for the Promoting Interoperability performance category
may still hold value for some health care providers and may be utilized
as best suits their practice and the preferences of their patient
population. The removal of measures is not intended to discourage the
use of the standards, the implementation of best practices, or
conducting and tracking the information for providers' own quality
improvement goals.
Comment: Another commenter stated that that the measure did not
accomplish its intended goal since we did not specify the manner in
which health care providers would incorporate the data received.
Response: We agree that it is important to encourage providers to
obtain data generated by patients, for instance, through the use of
consumer-facing devices, and utilize this data to inform decision-
making and provide more effective patient-centered care. While we are
finalizing removal of the Patient-Generated Health Data measure for the
reasons discussed in the proposed rule, we will continue to consider
ways to encourage this activity.
Comment: Many commenters supported the removal of this measure. A
commenter supported the removal of this measure because it is
burdensome and takes valuable time away from patient care. Another
commenter supported the removal of this measure but mentioned that
allowing the transmission of key health data such as home blood
pressure readings, finger-stick glucose levels, and other vitals is
still beneficial to the patient. This functionality should thus remain
available in CEHRT. Another suggested that CMS promote the use of
patient-generated health data collected via remote monitoring by
encouraging the development of open APIs across CEHRT developers.
Response: While we are removing the measure from the Promoting
Interoperability performance category, the functionality is not being
removed from 2015 Edition CEHRT. We will continue to work with ONC to
encourage the development of innovative API functionality that supports
exchange of patient-generated health data.
After consideration of the public comments we received, we are
removing the Patient-Generated Health Data measure as proposed.
(C) Removal of the Patient-Specific Education Measure
We proposed to remove the Patient-Specific Education measure (83 FR
35928) as it has proven burdensome to MIPS eligible clinicians in ways
that were unintended and detracts from their progress on current
program priorities.
The Patient-Specific Education measure was finalized as a
performance score measure for MIPS eligible clinicians in the CY 2017
Quality Payment Program final rule with the intent of improving patient
health, increasing transparency and engaging patients in their care (81
FR 77228 through 77237).
We stated that we believe that the Patient-Specific Education
measure does not align with the current emphasis of the Promoting
Interoperability performance category to increase interoperability, or
reduce burden for MIPS eligible clinicians. In addition to not
including interoperability as a core focus, stakeholders have indicated
that this measure does not capture many of the innovative activities
around providing patient education, for instance new approaches to
integrating patient education within clinical decision support modules.
As a result of this lack of alignment, this measure could potentially
increase clinician burden.
We solicited comment on this proposal and our summary and response
are below.
Comment: Many commenters supported the removal of this measure. A
commenter supported the removal of this measure because it is
burdensome. Other commenters stated that reporting on this measure
takes valuable time away from patient care and leads to clinician
frustration and ultimately contributes to burnout. Another commenter
agreed with the removal of the measure because it does not align with
promoting interoperability.
Response: We appreciate the commenters' support for the removal of
this measure.
Comment: Several commenters disagreed with the removal of this
measure. One commenter stated that the removal of this measure signals
that patient and caregiver engagement has taken a backseat to provider
to provider care coordination. Another commenter stated that the
measure is vital to improved health literacy that empowers patient
self-care which reduces unnecessary utilization and decreases costs.
One commenter stated the measure should be used to provide patients
with information about relevant clinical trials, medication adherence
tools, and opioid management strategies. A few commenters stated that
providing patients with relevant education materials raises their
health literacy and enables them to be more active in managing their
own health. Several commenters recommended that the measure be
available for bonus points.
Response: We disagree that the Patient-Specific Education measure
should be retained as a required measure. While we believe that there
are

[[Page 59814]]

merits to the Patient-Specific Education measure as identified by the
commenters, we affirm our position that the Patient-Specific Education
measure does not align with the current emphasis of the Promoting
Interoperability performance category which aims to increase
interoperability, leverage the most current health IT functions and
standards and reduce burden for MIPS eligible clinicians. We also
decline to offer bonus points for this measure. We note that bonus
points should be reserved for brand new measures to help to ease the
transition to becoming a required measure.
After consideration of the public comments we received, we are
removing of the Patient-Specific Education measure as proposed.
(D) Removal of the Secure Messaging Measure
We proposed to remove the Secure Messaging measure (82 FR 35929) as
it has proven burdensome to MIPS eligible clinicians in ways that were
unintended and detracts from MIPS eligible clinicians' progress on
current program priorities.
The Secure Messaging measure was finalized in the CY 2017 Quality
Payment Program final rule with the intent to build upon the policy
goals of Stage 2 under the EHR Incentive Programs of using CEHRT for
health care provider-patient communication (81 FR 77227 through 77236).
We stated that we believe that the Secure Messaging measure does not
align with the current emphasis of the Promoting Interoperability
performance category to increase interoperability or reduce burden for
MIPS eligible clinicians. In addition, we stated that we believe there
is burden associated with tracking secure messages, including the
unintended consequences of workflows designed for the measure rather
than for clinical and administrative effectiveness.
We solicited comment on this proposal and our summary and response
are below.
Comment: Some commenters opposed the removal of this measure
because it supports meaningful improvements in interoperability. Other
commenter noted that it must remain a required measure because it
ensures that patients can communicate confidentially with their health
care providers. Some commenters stated that some health care providers
rely on secure messaging to communicate with patients in an effective
and timely manner.
Response: We believe that there is a significant burden associated
with tracking secure messages. Although we are not requiring the
measure, the functionality remains in 2015 Edition CEHRT so MIPS
eligible clinicians may continue to utilize the functionality if they
choose.
Comment: Many commenters supported the removal of this measure.
Some commenters stated that they supported the removal of this measure
because it is burdensome, and reporting on this measure takes valuable
time away from patient care and leads to clinician frustration and
ultimately contributes to burnout.
Response: We agree that this measure may detract from MIPS eligible
clinicians' progress on current program priorities such as increasing
interoperability and reducing burden.
After consideration of the public comments we received, we are
removing the Secure Messaging measure as proposed.
(E) Removal of the View, Download or Transmit Measure
We proposed to remove the View, Download or Transmit measure (83 FR
35929) as it has proven burdensome to MIPS eligible clinicians in ways
that were unintended and detracts from their progress on current
program priorities.
We stated that we have received MIPS eligible clinician and
stakeholder feedback through correspondence, public forums, and
listening sessions indicating there is ongoing concern with measures
which require patient action for successful submission. We have noted
that data analysis on the patient action measures supports stakeholder
concerns that barriers exist which impact a clinician's ability to meet
them. Stakeholders have indicated that successful submission of the
measure is reliant upon the patient, who may face barriers to access
which are outside a clinician's control.
After additional review, we noted that successful performance
predicated solely on a patient's action has inadvertently created
burdens to MIPS eligible clinicians and detracts from progress on
Promoting Interoperability measure goals of focusing on patient care,
interoperability and leveraging advanced used of health IT. Therefore,
we proposed to remove the View, Download or Transmit measure.
We solicited comment on this proposal and our summary and response
are below.
Comment: Commenters supported the removal of this measure. One
commenter stated that the View, Download, and Transmit measure is
challenging because many practices that care for a much older
population of patients are at a disadvantage for this measure because
many of those patients do not own a computer or even have an email
address and in some cases, do not own a cell phone. Another commenter
appreciated the proposal to remove this measure and noted that CMS
should not hold MIPS eligible clinicians accountable for actions beyond
their control.
Response: Previous stakeholder feedback through correspondence,
public forums, and listening sessions indicated there is ongoing
concern with measures which require health care providers to be
accountable for patient actions such as viewing, downloading, or
transmitting. We further understand that there are barriers which could
negatively impact a MIPS eligible clinician's ability to successfully
meet a measure requiring patient action, such as location in remote,
rural areas and access to technology including computers, internet and/
or email. We believe that removing the patient action measures will
allow for focus on program goals of increasing interoperability and
patient access to their health information.
Comment: One commenter expressed concern about the removal of this
measure and noted that it will limit the effectiveness of driving
meaningful improvements in interoperability. One commenter stated that
the removal of this measure signals that patient and caregiver
engagement has taken a backseat to provider to provider care
coordination.
Response: We disagree that the removal of this measure devalues
patient and caregiver engagement as we are weighting the Provide
Patients Electronic Access to their Health Information measure at 40
points, the highest of any measure in the Promoting Interoperability
performance category in recognition of the value of patients having
electronic access to their health information. We are removing the
View, Download, Transmit measure because of the burden it places on
MIPS eligible clinicians to be accountable for patient action.
After consideration of the public comments we received, we are
removing the View, Download or Transmit measure as proposed.
In summary, we are removing the Coordination of Care Through
Patient Engagement objective and its associated measures: View,
Download or Transmit; Secure Messaging; and Patient-Generated Health
Data. We are renaming the Patient Electronic Access objective to
Provider to Patient Exchange objective and removing the Patient-
Specific Education measure. We are renaming the Provide Patient Access

[[Page 59815]]

measure to Provide Patients Electronic Access to their Health
Information.
(v) Modifications to the Public Health and Clinical Data Registry
Reporting Objective and Measures
In connection with the scoring methodology proposed in section
III.H.3.h.(5)(d) of the proposed rule, in the CY 2019 PFS proposed rule
(83 FR 35929 through 35931), we proposed changes to the Public Health
and Clinical Data Registry Reporting objective and five associated
measures.
We stated that we believe that public health reporting through EHRs
will extend the use of electronic reporting solutions to additional
events and care processes, increase timeliness and efficiency of
reporting and replace manual data entry.
We proposed to change the name of the objective to Public Health
and Clinical Data Exchange and proposed exclusions for each of the
associated measures.
Under the new scoring methodology proposed in section
III.H.3.h.(5)(d) of the proposed rule, we proposed that a MIPS eligible
clinician would be required to submit two of the measures of the
clinician's choice from the five measures associated with the
objective: Immunization Registry Reporting, Syndromic Surveillance
Reporting, Electronic Case Reporting, Public Health Registry Reporting,
and Clinical Data Registry Reporting.
In prior rulemaking, we recognized the goal of increasing
interoperability through public health registry exchange of data (80 FR
62771). We stated that we continue to believe that public health
reporting is valuable in terms of health information exchange between
MIPS eligible clinicians and public health and clinical data
registries. For example, when immunization information is directly
exchanged between EHRs and registries, patient information may be
accessed by all of a patient's health care providers for improved
continuity of care and reduced health care provider burden, as well as
supporting population health monitoring.
We also proposed exclusion criteria for each of the Public Health
and Clinical Data Exchange measures beginning with the performance
period in 2019. Under the scoring methodology for the Promoting
Interoperability performance category for the performance period in
2018 (82 FR 53676 through 53677), the measures associated with the
Public Health and Clinical Data Registry Reporting objective are not
required for the base score, and thus we did not establish exclusion
criteria for them. However, we understand that some MIPS eligible
clinicians may not be able to report to public health agencies or
clinical data registries due to their scope of practice. Therefore, we
proposed the following measure exclusions based on the exclusions
finalized in previous rulemaking under the EHR Incentive Programs (80
FR 62862 through 62871).
Measure: Immunization Registry Reporting.
Proposed Exclusions: Any MIPS eligible clinician meeting one or
more of the following criteria may be excluded from the Immunization
Registry Reporting measure if the MIPS eligible clinician:
1. Does not administer any immunizations to any of the populations
for which data is collected by its jurisdiction's immunization registry
or immunization information system during the performance period.
2. Operates in a jurisdiction for which no immunization registry or
immunization information system is capable of accepting the specific
standards required to meet the CEHRT definition at the start of the
performance period.
3. Operates in a jurisdiction where no immunization registry or
immunization information system has declared readiness to receive
immunization data as of 6 months prior to the start of the performance
period.
Measure: Syndromic Surveillance Reporting.
Proposed Exclusions: Any MIPS eligible clinician meeting one or
more of the following criteria may be excluded from the Syndromic
Surveillance Reporting measure if the MIPS eligible clinician:
1. Is not in a category of health care providers from which
ambulatory syndromic surveillance data is collected by their
jurisdiction's syndromic surveillance system.
2. Operates in a jurisdiction for which no public health agency is
capable of receiving electronic syndromic surveillance data in the
specific standards required to meet the CEHRT definition at the start
of the performance period.
3. Operates in a jurisdiction where no public health agency has
declared readiness to receive syndromic surveillance data from MIPS
eligible clinicians as of 6 months prior to the start of the
performance period.
Measure: Electronic Case Reporting.
Proposed Exclusions: Any MIPS eligible clinician meeting one or
more of the following criteria may be excluded from the Electronic Case
Reporting measure if the MIPS eligible clinician:
1. Does not treat or diagnose any reportable diseases for which
data is collected by their jurisdiction's reportable disease system
during the performance period.
2. Operates in a jurisdiction for which no public health agency is
capable of receiving electronic case reporting data in the specific
standards required to meet the CEHRT definition at the start of the
performance period.
3. Operates in a jurisdiction where no public health agency has
declared readiness to receive electronic case reporting data as of 6
months prior to the start of the performance period.
Measure: Public Health Registry Reporting.
Proposed Exclusions: Any MIPS eligible clinician meeting one or
more of the following criteria may be excluded from the Public Health
Reporting measure if the MIPS eligible clinician;
1. Does not diagnose or directly treat any disease or condition
associated with a public health registry in the MIPS eligible
clinician's jurisdiction during the performance period.
2. Operates in a jurisdiction for which no public health agency is
capable of accepting electronic registry transactions in the specific
standards required to meet the CEHRT definition at the start of the
performance period.
3. Operates in a jurisdiction where no public health registry for
which the MIPS eligible clinician is eligible has declared readiness to
receive electronic registry transactions as of 6 months prior to the
start of the performance period.
Measure: Clinical Data Registry Reporting.
Proposed Exclusions: Any MIPS eligible clinician meeting one or
more of the following criteria may be excluded from the Clinical Data
Registry Reporting measure if the MIPS eligible clinician;
1. Does not diagnose or directly treat any disease or condition
associated with a clinical data registry in their jurisdiction during
the performance period.
2. Operates in a jurisdiction for which no clinical data registry
is capable of accepting electronic registry transactions in the
specific standards required to meet the CEHRT definition at the start
of the performance period.
3. Operates in a jurisdiction where no clinical data registry for
which the MIPS eligible clinician is eligible has declared readiness to
receive electronic registry transactions as of 6 months prior to the
start of the performance period.
We solicited comment on the proposed exclusions and whether there
are circumstances that would require

[[Page 59816]]

additional exclusion criteria for the measures.
In addition, we stated that we intend to propose in future
rulemaking to remove the Public Health and Clinical Data Exchange
objective and measures no later than CY 2022, and solicited public
comment on whether MIPS eligible clinicians will continue to share such
data with public health entities once the Public Health and Clinical
Data Exchange objective is removed, as well as other policy levers
outside of the Promoting Interoperability performance category that
could be adopted for continued reporting to public health and clinical
data registries, if necessary. As noted above, although we believe that
these registries provide the necessary monitoring of public health
nationally and contribute to the overall health of the nation, we are
also focused on reducing burden and identifying other appropriate
venues in which reporting to public health and clinical data registries
could be reported. We solicited public comment on the role that each of
the public health and clinical data registries should have in the
future of the Promoting Interoperability performance category and
whether the submission of this data should still be required.
Lastly, we solicited public comment on whether the Promoting
Interoperability performance category is the best means for promoting
sharing of clinical data with public health entities.
We solicited comment on these proposals and our summary and
response are below.
Comment: One commenter stated that these measures should be
optional as they continue to remain difficult for MIPS eligible
clinicians due to the lack of availability of interoperable public
health registries. Another commenter noted that the measures should be
a bonus and not required as they note that the path for participation
is convoluted and will require an onerous amount of effort on the part
of the clinician. Commenters also noted issues with AHRQ's Registry of
Patient Registries such as difficulty searching for registries that
would fulfill the Promoting Interoperability performance category's
requirement.
Response: We disagree as we are trying to simplify scoring by
limiting bonus opportunities to brand new measures. Hence we are
offering bonus points for reporting the two new measures under the e-
Prescribing objective but not the ``new'' measure under the Health
Information Exchange objective because it is simply the combination of
two existing measures. We know that there are some improvements that
need to be made to AHRQ's Registry of Patient Registries and we are
working with AHRQ and CDC to improve the search capabilities so that
available registries can be easily located.
Comment: Many commenters opposed CMS' intent to remove the Public
Health and Clinical Data Exchange objective and measures in the future
and noted that interoperability of public health data is still evolving
and incentivizes MIPS eligible clinicians to share data with public
health agencies. One commenter encouraged CMS to reconsider removing
the objective and measures for the following reasons: Many states do
not have other policy levers outside the Promoting Interoperability
programs and performance category to encourage or enforce public health
reporting; CMS and States have spent many years now, using HITECH Act
funding, supporting improvements to public health systems and HIEs to
encourage health care providers to submit public health data, and thus,
the reporting should continue; and in some states public health
reporting is one of the driving use cases for participants to connect
to their statewide HIE and removing these measures would remove an
incentive to encourage health care providers to participate in HIEs.
Another commenter expressed concerns about CMS' intention to remove the
Public Health and Clinical Data Exchange objectives and measures noting
that it is a significant policy lever for those who have yet to engage
in this aspect of the program.
Response: We understand the importance of reporting to public
health and clinical data registries. We are continuing to focus on
burden reduction, as well as other platforms and venues for reporting
data to public health and clinical data registries outside of the
Promoting Interoperability performance category. We will continue to
monitor the data we compile specific to the public health reporting
requirements and take the commenters' concerns into consideration in
future rulemaking.
Comment: One commenter requested clarification of whether a MIPS
eligible clinician can submit to two different registries for purposes
of the same measure and get credit for submitting to two registries, or
must they report to different registries for purposes of two different
measures to receive full credit for the objective.
Response: Although we proposed that a MIPS eligible clinician must
report on two measures of their choice to fulfill the Public Health and
Clinical Data Registry Reporting objective, we agree that a MIPS
eligible clinician should be able to report to two different public
health agencies or clinical data registries for purposes of the same
measure. Therefore, as previously discussed in section III.H.3.(5)(d)
of this final rule, we are finalizing the proposal with modification so
that a MIPS eligible clinician may earn full credit for this objective
by reporting to two different public health agencies or clinical data
registries for purposes of the same measure.
Comment: Some commenters agreed with the Public Health and Clinical
Data Exchange reporting requirements proposed, stating they would
continue to advance interoperability and improve early detection of
outbreaks as well as promote population health strategies.
Response: We appreciate the support for our proposal and believe
that public health reporting through EHRs will extend the use of
electronic reporting solutions to additional events and care processes
and increase the timeliness and efficiency of reporting.
Comment: A few commenters supported the proposed exclusions for the
Public Health and Clinical Data Exchange measures. One commenter
suggested that the first exclusion for the Immunization Registry
Reporting measure be modified to 100 or less immunizations in a
performance period.
Response: We decline to expand the first exclusion for the
Immunization Registry Reporting measure because if the MIPS eligible
clinician is performing any immunizations we believe that the
information should be reported to an immunization registry.
Comment: One commenter recommended that CMS specify that exclusions
may only be claimed if a MIPS eligible clinician meets exclusions for
all of the measures associated with the Public Health and Clinical Data
Exchange objective and has made all possible efforts to report on the
measures for this objective. The commenter suggested that participation
in this objective should be encouraged instead of claiming exclusions,
which would not improve interoperability or support improvements to
population health. Commenters also stated that public health reporting
also supports added value for individuals and reporters by enabling
bidirectional information exchange between clinical care and public
health.
Response: We agree that MIPS eligible clinicians should try to find
public health registries with which they can be in active engagement.
We understand the concerns of the commenters and are committed to
reducing provider burden

[[Page 59817]]

while increasing flexibility. As previously discussed in section
III.H.3.(5)(d) of this final rule, we believe the ability to report to
two different public health agencies or clinical data registries will
promote flexibility in reporting and enables MIPS eligible clinicians
to focus on the measures that are most relevant to them and their
patient population.
After consideration of the comments we received, we are finalizing
our proposals with modification. We are changing the name of the
objective to Public Health and Clinical Data Exchange and adopting
exclusions for each of the associated measures. As previously discussed
in section III.H.3.(5)(d) of this final rule, we are adopting a final
policy to allow MIPS eligible clinicians to earn full credit for this
objective by reporting to two different public health agencies or
clinical data registries for any of the measures associated with the
objective.
We may use the comments that we received on the removal of the
Public Health and Clinical Data Exchange objectives and measures to
inform future rulemaking.
To assist readers in identifying the requirements of CEHRT for the
Promoting Interoperability performance category objectives and measures
under the scoring methodology we are finalizing in section
III.I.3.h.(5)(d) of this final rule, we include Table 43, which
includes the 2015 Edition certification criteria required to meet the
objectives and measures.
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BILLING CODE 4120-01-C
(vi) Request for Comment--Potential New Measures Health Information
Exchange Across the Care Continuum
We are working to introduce additional flexibility to allow MIPS
eligible clinicians a wider range of options in selecting measures that
are most appropriate to their setting, patient population, and clinical
practice improvement goals. For this reason, in the CY 2019 PFS
proposed rule (83 FR 35931) we solicited comment on a potential concept
for future rulemaking to add two additional measure options related to
health information exchange for MIPS eligible clinicians.
---------------------------------------------------------------------------

\28\ References from Title 45.
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We received many comments in response to our request, and we will
consider them as we develop future policy regarding the potential new
measures that focus on health information exchange across the care
continuum.

[[Page 59818]]

(g) Improvement Activities Bonus Score Under the Promoting
Interoperability Performance Category and Future Reporting
Considerations
In the CY 2017 Quality Payment Program final rule (81 FR 77202), we
discussed our approach to the measurement of the use of CEHRT to allow
MIPS eligible clinicians and groups the flexibility to implement CEHRT
in a way that supports their clinical needs. Toward that end, we
adopted a policy for the 2017 and 2018 performance periods (81 FR
77202-77209 and 82 FR 53664-53670) and codified it at Sec.
414.1380(b)(4)(i)(C)(2) to award a bonus score to MIPS eligible
clinicians who use CEHRT to complete certain activities in the
improvement activities performance category based on our belief that
the use of CEHRT in carrying out these activities could further the
outcomes of clinical practice improvement.
In the CY 2019 PFS proposed rule (83 FR 35932 through 35935), we
proposed significant changes to the scoring methodology and measures
beginning with the performance period in 2019. In connection with these
changes, we did not propose to continue the bonus for completing
certain improvement activities using CEHRT for the performance period
in 2019 and subsequent performance periods. As discussed in section
III.H.3.h.(5)(b) of the proposed rule, we shifted the focus of this
performance category to put a greater emphasis on interoperability and
patient access to health information, and we stated that we do not
believe awarding a bonus for performing an improvement activity using
CEHRT would directly support those goals. While we continued to believe
that the use of CEHRT in completing improvement activities is extremely
valuable and vital to the role of CEHRT in practice improvement,
awarding a bonus in the Promoting Interoperability performance category
would not be appropriate in light of the new direction we wanted to
take, and we solicited comment on other ways to promote the use of
CEHRT.
We invited comments on our decision not to propose to continue the
bonus for completing certain improvement activities using CEHRT for the
performance period in 2019 and subsequent performance periods, and our
responses are below.
Comment: Commenters supported our decision not to continue the
bonus points for completing improvement activities using CEHRT.
Response: We appreciate the support and although we are
discontinuing the bonus points, we will continue to seek other
opportunities to promote the use of CEHRT.
Comment: Some commenters stated that they opposed our decision not
to continue the bonus points for completing improvement activities
using CEHRT stating that providing bonus points in the Promoting
Interoperability performance category represented CMS' understanding
that health IT can play an invaluable role in improving outcomes and
incentivized MIPS eligible clinicians to incorporate health IT into
their practice workflows and clinical activities. The commenters
requested that CMS continue to incentivize--but not require--clinicians
to use health IT as they accomplish improvement activities.
Response: We are limiting bonus points to brand new measures in the
Promoting Interoperability performance category such as the Verify
Opioid Treatment Agreement measure. We are exploring opportunities that
would allow MIPS eligible clinicians to earn credit across multiple
MIPS performance categories. We continue to believe that the use of
health IT, telehealth, and connection of patients to community-based
services is important. We encourage the use of health IT as we
understand it is an important aspect of the care delivery processes
described in many of the established improvement activities found at
https://qpp.cms .gov/. In addition, we encourage stakeholders to submit
new improvement activities through the Annual Call for Activities that
encourage the use of health IT.
After consideration of the comments received, we are not continuing
the bonus points for completing improvement activities using CEHRT.
We acknowledged that the omission of this bonus could be viewed as
increasing burden, and sought to counteract that concern by evaluating
other methods to reduce burden to offset this potential increase. We
have also considered various ways to align and streamline the different
performance categories under the MIPS. In lieu of the improvement
activities bonus score, we have looked extensively at ways to link
three of the performance categories--quality, improvement activities
and Promoting Interoperability--to reduce burden and create a more
cohesive and closely linked MIPS program. One possibility we have
identified is to establish several sets of new multi-category measures
that would cut across the different performance categories and allow
MIPS eligible clinicians to report once for credit in all three
performance categories. Our goal would be to establish several of
combined measures so MIPS eligible clinicians could report once for
credit across all three performance categories. We only solicited
comment on this concept, as we are still evaluating the appropriate
measure combinations and feasibility of a multi-category model.
Furthermore, we stated that to promote measurement that provides
clinicians with measures that are meaningful to their practices, we
intend to consider proposing in future rulemaking MIPS public health
priority sets across the four performance categories (quality,
improvement activities, Promoting Interoperability, and cost), and
solicited comments on this topic.
We thank commenters for their views and we will consider their
views as we develop future policy proposals.
(h) Additional Considerations
(i) Nurse Practitioners, Physician Assistants, Clinical Nurse
Specialists, and Certified Registered Nurse Anesthetists
In prior rulemaking (82 FR 30079), we discussed our belief that
certain types of MIPS eligible clinicians (NPs, PAs, CNSs, and CRNAs)
may lack experience with the adoption and use of CEHRT. Because many of
these non-physician clinicians were or are not eligible to participate
in the Medicare or Medicaid EHR Incentive Program (now known as the
Promoting Interoperability Program), we stated that we have little
evidence as to whether there are sufficient measures applicable and
available to these types of MIPS eligible clinicians under the
advancing care information (now known as Promoting Interoperability)
performance category. We established a policy for the performance
periods in 2017 and 2018 under section 1848(q)(5)(F) of the Act to
assign a weight of zero to the advancing care information performance
category in the MIPS final score if there are not sufficient measures
applicable and available to NPs, PAs, CRNAs, and CNSs. We will assign a
weight of zero only in the event that an NP, PA, CRNA, or CNS does not
submit any data for any of the measures specified for the advancing
care information performance category, but if they choose to report,
they will be scored on the advancing care information performance
category like all other MIPS eligible clinicians and the performance
category will be given the weighting prescribed by section
1848(q)(5)(E) of the Act. We stated our intention to use data from the
first performance period (2017) to further evaluate the participation
of

[[Page 59819]]

these MIPS eligible clinicians in the advancing care information
performance category and consider for subsequent years whether the
measures specified for this category are applicable and available to
these MIPS eligible clinicians. In the CY 2019 PFS proposed rule (83 FR
35933), we stated that as we have not yet analyzed the data for the
first MIPS performance period, it would be premature to propose to
alter our treatment of these MIPS eligible clinicians in year 3.
Accordingly, we proposed to continue this policy for the
performance period in 2019 and to codify the policy at Sec.
414.1380(c)(2)(i)(A)(5). We requested public comments on this proposal.
The following is a summary of the comments we received on this
proposal.
Comment: One commenter suggested that PAs and NPs not have their
Promoting Interoperability performance category reweighted with
possible exceptions for small PA and NP-owned practices. The commenter
indicated that PAs have been using CEHRT for years and should be held
to the same standards and expectations as physicians.
Response: We agree that the goal is to have all MIPS eligible
clinicians use CEHRT. However, we believe that at this point in time it
is premature to determine whether there are sufficient measures
applicable and available to NPs, PAs, CNSs, and CRNAs. We plan to
analyze performance data as it becomes available to inform future
rulemaking. We note that if NPs and PAs choose to report data for the
Promoting Interoperability performance category, they will be scored
like all other MIPS eligible clinicians and the performance category
will be given the weighting prescribed by section 1848(q)(5)(E) of the
Act regardless of their Promoting Interoperability performance category
score.
After consideration of the comments we received, we will continue
the policy for NPs, PAs, CRNAs, and CNSs for the performance period in
2019 as proposed. We are codifying the policy at Sec.
414.1380(c)(2)(i)(A)(5) as proposed.
(ii) Physical Therapists, Occupational Therapists, Clinical Social
Workers, and Clinical Psychologists
As discussed in section III.H.3.a. of the proposed rule, in
accordance with section 1848(q)(1)(C)(i)(II) of the Act, we proposed to
add the following clinician types to the definition of a MIPS eligible
clinician, beginning with the performance period in 2019: Physical
therapists; occupational therapists; clinical social workers; and
clinical psychologists (83 FR 35883 through 35884). For the reasons
discussed in prior rulemaking and in the preceding section
III.H.3.h.(5)(f) of the proposed rule, we proposed(83 FR 35933) to
apply the same policy we adopted for NPs, PAs, CNSs, and CRNAs for the
performance periods in 2017 and 2018 to these new types of MIPS
eligible clinicians for the performance period in 2019. Because many of
these clinician types were or are not eligible to participate in the
Medicare or Medicaid Promoting Interoperability Program, we stated that
we have little evidence as to whether there are sufficient measures
applicable and available to them under the Promoting Interoperability
performance category. Thus, we proposed to rely on section
1848(q)(5)(F) of the Act to assign a weight of zero to the Promoting
Interoperability performance category if there are not sufficient
measures applicable and available to these new types of MIPS eligible
clinicians (physical therapists, occupational therapists, clinical
social workers, and clinical psychologists). We encouraged all of these
new types of MIPS eligible clinicians to report on these measures to
the extent they are applicable and available; however, we understand
that some of them may choose to accept a weight of zero for this
performance category if they are unable to fully report the Promoting
Interoperability measures. We stated that we believe this approach is
appropriate for their first performance period (in 2019) based on the
payment consequences associated with reporting, the fact that many of
these types of MIPS eligible clinicians may lack experience with EHR
use, and our current uncertainty as to whether we have proposed
sufficient measures that are applicable and available to these types of
MIPS eligible clinicians. We would use their first performance period
to further evaluate the participation of these MIPS eligible clinicians
in the Promoting Interoperability performance category and would
consider for subsequent years whether the measures specified for this
category are applicable and available to these MIPS eligible
clinicians.
We stated that these MIPS eligible clinicians may choose to submit
Promoting Interoperability performance category measures if they
determine that these measures are applicable and available to them;
however, if they choose to report, they would be scored on the
Promoting Interoperability performance category like all other MIPS
eligible clinicians and the performance category would be given the
weighting prescribed by section 1848(q)(5)(E) of the Act regardless of
their Promoting Interoperability performance category score.
We proposed to codify this policy at Sec. 414.1380(c)(2)(i)(A)(4).
The following is a summary of the comments we received on this
proposal.
Comment: A few commenters stated that they are very pleased that
CMS proposed to assign a weight of zero to the Promoting
Interoperability performance category for physical and occupational
therapists. The commenters stated that this is appropriate because the
four included objectives have minimal relevance to therapy.
Additionally, commenters noted that PTs and OTs have not received any
financial incentives or support for implementing CEHRT, and therefore,
it would be inappropriate to require them to report on measures for the
Promoting Interoperability performance category.
Response: We will continue to monitor participation of physical
therapists, occupational therapists, and clinical psychologists to
evaluate whether there are sufficient measures applicable and available
to them. Our intention is not to continue the proposed policy in
perpetuity. We believe that for increased interoperability and health
information exchange it is important for all types of MIPS eligible
clinicians to use CEHRT, and we aim to adopt measures for the Promoting
Interoperability performance category that are available and applicable
to all types of MIPS eligible clinicians.
Comment: A commenter recommended that these types of clinicians not
be automatically reweighted and instead recommended the creation of
some sort of methodology to encourage health IT utilization and
interoperability goals for these clinician types.
Response: We disagree. We believe these specialties may not have
sufficient measures applicable and available to them. We believe that
through enabling these specialties to report if they are able or be
reweighted if they are not, will give these specialties more time if
they need it as they may not be familiar with the use of CEHRT. The
reweighting will not be forever, but will be in place until we can
determine through data analysis that these specialties are reporting in
sufficient numbers to require their participation in the Promoting
Interoperability performance category.
After consideration of the comments that we received, we are
adopting our proposal with modification. In section

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III.I.3.a. of this final rule, we are adopting a final policy to add
the following types of clinicians to the definition of MIPS eligible
clinician: Physical therapist, occupational therapist. qualified
speech-language pathologist, qualified audiologist, clinical
psychologist, and registered dietitian or nutritional professional. For
the reasons discussed in the proposed rule, we will apply the same
policy we adopted for NPs, PAs, CNSs, and CRNAs for the performance
periods in 2017 and 2018 to each of these new types of MIPS eligible
clinicians for the performance period in 2019. We are not adopting a
policy related to clinical social workers because they are not being
added as MIPS eligible clinicians at this time. We are finalizing the
proposed regulation text at Sec. 414.1380(c)(2)(i)(A)(4) to reflect
these modifications.
(6) APM Scoring Standard for MIPS Eligible Clinicians Participating in
MIPS APMs
(a) Overview
As codified at Sec. 414.1370, MIPS eligible clinicians, including
those participating in MIPS APMs, are subject to MIPS reporting
requirements and payment adjustments, unless excluded on another basis.
In the CY 2017 Quality Payment Program rule, we finalized the APM
scoring standard, which is designed to reduce reporting burden for
participants in certain APMs by reducing the need for duplicative data
submission to MIPS and their respective APMs, and to avoid potentially
conflicting incentives between those APMs and the MIPS.
We established at Sec. 414.1370(c) that the MIPS performance
period under Sec. 414.1320 applies for the APM scoring standard. We
finalized under Sec. 414.1370(f) that, under the APM scoring standard,
MIPS eligible clinicians will be scored at the APM entity group level
and each MIPS eligible clinician will receive the APM Entity's final
MIPS score. In the CY 2019 PFS proposed rule, we proposed to amend
Sec. 414.1370(f)(2) to state that if the APM Entity group is excluded
from MIPS, all eligible clinicians within that APM Entity group are
also excluded from MIPS.
The MIPS final score under the APM scoring standard is comprised of
the four MIPS performance categories as finalized at Sec. 414.1370(g):
Quality; cost; improvement activities; and advancing care information.
In 2018, these performance categories are scored at 50 percent, 0
percent, 30 percent, and 20 percent, respectively.
(b) Summary of Proposals
In the CY 2019 PFS proposed rule, we discussed the following
proposed policies:
We proposed to revise Sec. 414.1370(b)(3) to clarify the
requirement for MIPS APMs to assess performance on quality measures and
cost/utilization.
We proposed to modify the Shared Savings Program quality
reporting requirements by expanding the reporting exception for solo
practitioners such that, beginning in 2019, in the case of a Shared
Savings Program ACO's failure to report quality measures as required by
the Shared Saving Program, we will allow a solo practitioner to report
on any available MIPS measures, including individual measures.
We proposed to clarify that, beginning in 2019, the
complete reporting requirement for Web Interface reporters be modified
to specify that if an APM Entity fails to complete reporting for Web
Interface measures but successfully reports the CAHPS for ACOs survey,
we will score the CAHPS for ACOs survey and apply it towards the APM
Entity's quality performance category score. In this scenario, the
Shared Savings Program TIN-level reporting exception will not be
triggered and all MIPS eligible clinicians within the ACO will receive
the APM Entity score.
We clarified that we will consider each distinct track of
an APM and whether it meets the criteria necessary to be a MIPS APM
under Sec. 414.1370(b)(1). We further clarified the term ``track'' to
refer to a distinct arrangement through which an APM Entity
participates in the APM, and that such participation is mutually
exclusive of the APM Entity's participation in another ``track'' within
the same APM.
We clarified our interpretation of the rule at Sec.
414.1370(b)(4)(i) for APMs that begin after the first day of the MIPS
performance period for the year (currently January 1), where quality
measures tied to payment must be reported for purposes of the APM from
the first day of the MIPS performance period, and indicated that we
consider the first performance year for an APM to begin as of the first
date for which eligible clinicians and APM entities participating in
the model must report on quality measures under the terms of the APM.
We proposed to remove the Promoting Interoperability
(formerly advancing care information) full-TIN reporting requirement
for participants in the Shared Savings Program to allow individual TIN/
NPIs to report for the Promoting Interoperability performance category.
We explained how performance feedback may be accessed by
ACO participant TINs in the Shared Savings Program.
We proposed to update the MIPS APM measure sets that apply
for purposes of the APM scoring standard.
(c) MIPS APM Criteria
In the CY 2017 Quality Payment Program final rule, we established
at Sec. 414.1370(b) that for an APM to be considered a MIPS APM, it
must satisfy the following criteria: APM Entities must participate in
the APM under an agreement with CMS or by law or regulation, the APM
must require that APM Entities include at least one MIPS eligible
clinician on a participation list, the APM must base payment incentives
on performance (either at the APM entity or eligible clinician level)
on cost/utilization and quality measures, and the APM must be neither a
new APM for which the first performance period begins after the first
day of the MIPS performance year, nor an APM in the final year of
operation for which the APM scoring standard is impracticable.
As stated in the CY 2019 PFS proposed rule (83 FR 35934), it has
come to our attention that there may have been some ambiguity in the
third criterion at Sec. 414.1370(b)(3). We have received questions as
to whether the criterion requires MIPS APMs to base payment incentives
on performance on cost/utilization ``measures'', or whether it requires
more generally that MIPS APMs base payment incentives on ``cost/
utilization.'' Because we did not address this exact point in prior
rulemaking and our intended policy is not strictly clear from the
regulation text, we clarified in the CY 2019 PFS proposed rule that we
intended the word ``measures'' at Sec. 414.1370(b)(3) to modify only
``quality'' and not ``cost/utilization.'' To make this criterion clear,
we proposed to modify the regulation to specify that a MIPS APM must be
designed in such a way that participating APM Entities are incentivized
to reduce costs of care or utilization of services, or both. This
proposed change to Sec. 414.1370(b)(3) would make it clear that a MIPS
APM could take into account performance in terms of cost/utilization
using model design features other than the direct use of cost/
utilization measures.
We solicited comment on this proposal.
The following is a summary of the public comments received on this
proposal and our responses:

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Comment: We received several comments supporting our proposal to
modify the criterion at Sec. 414.1370(b)(3) to clarify that the word
``measures'' only modifies the word ``quality'' and not ``cost/
utilization.'' Commenters stated that as proposed, this revision would
mean that a MIPS APM could take into account performance in terms of
cost/utilization using a cost/utilization measure and/or through other
model design features. One commenter noted appreciation of this
clarification and stated that this update to Sec. 414.1370(b)(3) will
allow participating APM Entities more flexibility when reporting cost/
utilization information. Further, this commenter stated that our
proposed clarification is consistent with CMS's intent and the implied
intent of MACRA. Another commenter expressed appreciation for this
clarification and noted that this may increase participation in MIPS.
Response: We agree with commenters that the policy as intended and
clarified allows for flexibility in how reporting cost/utilization
information is reported. We continue to believe that accounting for
cost/utilization performance can be accomplished by taking model design
features into account and it is unnecessary to rely solely on cost/
utilization measures. Therefore, we are finalizing our proposal to
modify Sec. 414.1370(b)(3) to specify that a MIPS APM must be designed
in a way that participating APM Entities are incentivized to reduce
costs of care or utilization of services, or both. We continue to
believe that this change to the regulation text will clarify our intent
that a MIPS APM could take into account performance in terms of cost/
utilization using model design features other than the direct use of
cost/utilization measures. We are revising Sec. 414.1370(b)(3), as
proposed, to state that the APM bases payment on performance (either at
the APM entity or eligible clinician level) on quality measures and
cost/utilization.
We also proposed to clarify that we will consider each distinct
track of an APM and whether it meets the criteria, in this final rule,
to be a MIPS APM, and that it is possible for an APM to have tracks
that are MIPS APMs and tracks that are not MIPS APMs. However, we
specified that we will not further consider whether the individual APM
Entities or MIPS eligible clinicians participating within a given track
each satisfy all of the MIPS APM criteria.
For purposes of this clarification, we understand the term
``track'' to refer to a distinct arrangement through which an APM
Entity participates in the APM, and that such participation is mutually
exclusive of the APM Entity's participation in another ``track'' within
the same APM. For example, we consider the three risk arrangements
under OCM to be three separate ``tracks.''
The following is a summary of the public comments received on this
clarification and our responses:
Comment: Some commenters supported our clarification. One commenter
noted that this clarification allows for maximum flexibility, and
allows APM the ability to offer different risk levels, which would, in
turn, expand the pool of participants able to join APMs.
Response: We appreciate the support, and agree with the commenter
that identifying MIPS APMs by considering each distinct track of an APM
against our criteria to be a MIPS APM would be likely to increase the
potential number of eligible participants to join MIPS APMs.
We will continue to evaluate whether each distinct track of an APM
meets our criteria to be a MIPS APM. We note that this may result in an
APM having tracks that are MIPS APMs and tracks that are not MIPS APMs.
We also clarified our interpretation of the regulation at Sec.
414.1370(b)(4)(i) for APMs that begin after the first day of the MIPS
performance period for the year (currently January 1), but require
participants to report quality data for quality measures tied to
payment for the full MIPS performance period, beginning January 1.
Under these circumstances where quality measures tied to payment must
be reported for purposes of the APM from the first day of the MIPS
performance period, we consider the first performance year for an APM
to begin as of the first date for which eligible clinicians and APM
entities participating in the model must report on quality measures
under the terms of the APM.
The following is a summary of the public comments received on this
clarification and our responses:
Comment: Commenters noted that this clarification will provide
flexibility to those eligible clinicians and APM entities participating
in an APM that begins after January 1. Commenters also stated that this
clarification would prevent duplicative reporting of quality measures
for both the APM and for MIPS, and would be consistent with CMS's
efforts to reduce administrative burden.
Response: We appreciate the commenters' support of our
clarification. We agree that our interpretation of Sec.
414.1370(b)(4)(i) will prevent duplicative reporting of quality
measures and is consistent with our other efforts to reduce
administrative burden.
We are clarifying our interpretation of the regulation at Sec.
414.1370(b)(4)(i). Therefore, we consider the first performance year
for an APM to begin as of the first date for which eligible clinicians
and APM entities participating in the model must report on quality
measures under the terms of the APM. We believe that this
interpretation will eliminate possibly conflicting incentives between
the quality scoring requirements and payment incentive structures under
the APM and MIPS and will reduce the likelihood of duplicative
reporting of quality information.
Based on the MIPS APM criteria we expect that the following 10 APMs
likely will satisfy the requirements to be MIPS APMs for the 2019
performance year:
Comprehensive ESRD Care Model (all Tracks).
Comprehensive Primary Care Plus Model (all Tracks).
Next Generation ACO Model.
Oncology Care Model (all Tracks).
Medicare Shared Savings Program (all Tracks).
Medicare ACO Track 1+ Model.
Bundled Payments for Care Improvement Advanced.
Independence at Home Demonstration.
Maryland Total Cost of Care Model (Maryland Primary Care
Program).
Vermont All-Payer ACO Model (Vermont Medicare ACO
Initiative).
Final CMS determinations of MIPS APMs for the 2019 MIPS performance
year will be announced via the Quality Payment Program website at
https://qpp.cms.gov/. Further, we make these determinations based on
the established MIPS APM criteria as specified in Sec. 414.1370(b) of
our regulation, taking into account the clarifications made in this
final rule.
(d) Calculating MIPS APM Performance Category Scores
(i) Quality Performance Category
For the quality performance category, MIPS eligible clinicians in
APM Entities will continue to be scored only on the quality measures
that are required under the terms of their respective APMs, and
available for scoring as specified in Sec. 414.1370(g)(1) and
explained in the CY 2017 Quality Payment Program final rule (82 FR
53698, 53692).
(A) Web Interface Reporters
In the CY 2018 Quality Payment Program final rule, we discussed the

[[Page 59822]]

requirements for MIPS eligible clinicians participating in a MIPS APM
that requires use of the CMS Web Interface for quality reporting,
subsequently referred to as ``Web Interface Reporters'' (82 FR 53954).
In that rule we finalized a policy to use quality measure data that
participating APM Entities submit using the CMS Web Interface and CAHPS
surveys as required under the terms of the APM (82 FR 53568, 53692). We
also codified at Sec. 414.1370(f)(1) a policy under which, in the
event a Shared Savings Program ACO does not report quality measures as
required by the Shared Savings Program under Sec. 425.508, each ACO
participant TIN will be treated as a unique APM entity for purposes of
the APM scoring standard, and may report data for the MIPS quality
performance category according to the MIPS submission and reporting
requirements.
For the 2019 MIPS performance year, we anticipate that there will
be four Web Interface Reporter APMs: The Shared Savings Program; the
Medicare ACO Track 1+ Model; Next Generation ACO Model; and the Vermont
All-Payer ACO Model (Vermont Medicare ACO Initiative).
(aa) Complete Reporting Requirement
Under Sec. 414.1370(f)(1), if a Shared Savings Program ACO does
not report data on quality measures as required by the Shared Savings
Program under Sec. 425.508, each ACO participant TIN will be treated
as a unique APM Entity for purposes of the APM scoring standard and the
ACO participant TINs may report data for the MIPS quality performance
category according to the MIPS submission and reporting requirements.
In the CY 2019 PFS proposed rule (83 FR 35935), we stated that we would
like to clarify that any ``partial'' reporting through the CMS Web
Interface that does not satisfy the requirements of the Shared Savings
Program will be considered a failure to report. Should a Shared Savings
Program ACO fail to report, the exception under Sec. 414.1370(f)(1) is
triggered. In this scenario, each ACO participant TIN has the
opportunity to report quality data to MIPS according to MIPS group
reporting requirements to avoid a score of zero for the quality
performance category (81 FR 77256).
We recognized that, under this policy, successfully reporting to
MIPS according to group reporting requirements may be difficult for
solo practitioners, for whom case thresholds and other requirements may
make many group reporting measures unavailable. Therefore, we proposed
to modify the exception such that beginning in 2019, in the case of a
Shared Savings Program ACO's failure to report quality measures as
required by the Shared Saving Program, we will also allow a solo
practitioner (a MIPS eligible clinician who has only one NPI billing
through their TIN), to report on any available MIPS measures, including
individual measures, in the event that their ACO fails to complete
reporting for all Web Interface measures.
The following is a summary of the public comments received on this
clarification and our responses:
Comment: One commenter noted that this modification will increase
Shared Savings Program ACO participants' flexibility in the unlikely
event that the ACO does not submit quality measures.
Response: We agree with the commenter that allowing solo
practitioners to report any available MIPS measures, including
individual measures, will allow additional flexibility when reporting
to MIPS in the event their ACO fails to complete the reporting of all
Web Interface measures.
After consideration of all public comments, we are clarifying that
beginning in 2019, in the case of a Shared Savings Program ACO's
failure to completely report all Web Interface measures as required by
the Shared Savings Program, we will allow a solo practitioner to report
on any available MIPS measures, including individual measures.
We also proposed, beginning with the 2019 performance period, to
modify the complete reporting requirement for Web Interface reporters
to specify that if an APM Entity (in this case, an ACO) fails to
complete reporting for Web Interface measures but successfully reports
the CAHPS for ACOs survey, we will score the CAHPS for ACOs survey and
apply it towards the APM Entity's quality performance category score.
In this scenario the Shared Savings Program TIN-level reporting
exception will not be triggered and all MIPS eligible clinicians within
the ACO will receive the APM Entity score.
We solicited comment on this proposal.
The following is a summary of the public comments received on this
proposal and our responses:
Comment: Some commenters supported our proposal. Other commenters
expressed concern about applying the CAHPS score for ACOs to the APM
Entity's quality performance score.
Response: Upon further consideration, we believe that the proposed
change could unduly limit the ACO participant TINs' opportunity to
achieve the highest possible quality performance category score: By
scoring the ACO entity's CAHPS score in this scenario, the entity's
total possible quality score would be capped at the total possible
CAHPS score. Therefore, in the case where an ACO entity fails to
successfully report Web Interface measures but does successfully report
CAHPS, we will continue to treat ACO participant TINs as unique APM
Entities under the APM scoring standard and will score each TIN only on
the MIPS measures it has reported, up to a score of 100 percent for the
performance category.
After taking all comments into account, we are not finalizing our
proposal to modify the complete reporting requirement for Web Interface
reporters to apply the CAHPS for ACOs survey score toward an APM
Entity's quality performance category score if an ACO fails to complete
reporting for Web Interface measures but successfully reports the CAHPS
for ACOs survey.
(B) Other MIPS APMs
Under Sec. 414.1370(g)(1)(ii), the MIPS quality performance
category score for a MIPS performance period is calculated for the APM
Entity using the data submitted by the APM Entity based on measures
specified by us through notice and comment rulemaking and available for
scoring for each Other MIPS APM from among those used under the terms
of the Other MIPS APM.
In the 2019 MIPS performance year, we anticipate that there will be
up to six Other MIPS APMs for which we will use this scoring
methodology, based on their respective measure sets and reporting
requirements:
The Oncology Care Model.
Comprehensive ESRD Care Model.
Comprehensive Primary Care Plus Model.
Bundled Payments for Care Improvement Advanced.
Maryland Total Cost of Care Model (Maryland Primary Care
Program).
Independence at Home Demonstration.
(ii) Promoting Interoperability Performance Category
In the CY 2017 Quality Payment Program final rule (81 FR 77262
through 77264; 81 FR 77266 through 77269), we established a policy at
Sec. 414.1370(g)(4)(ii) for MIPS APMs other than the Shared Savings
Program, under which we attribute one Promoting Interoperability
performance category score to each MIPS eligible clinician in an APM
Entity group based on the higher of either individual or group-level
data submitted for the MIPS

[[Page 59823]]

eligible. We will then use these scores to create an APM Entity group
score equal to the average of the highest scores available for each
MIPS eligible clinician in the APM Entity group.
For the Shared Savings Program, we also finalized at Sec.
414.1370(g)(4)(i) that ACO participant TINs are required to report on
the Promoting Interoperability performance category, and we will weight
and aggregate the ACO participant TIN scores to determine an APM Entity
group score (81 FR 77258 through 77260). This policy was meant to align
requirements between the MIPS Promoting Interoperability measures and
the Shared Savings Program ACO-11 measure, which is used to assess
Shared Savings Program ACOs based on the MIPS Promoting
Interoperability measures. However, we have found that limiting
reporting to the ACO participant TIN creates unnecessary confusion, and
restricts Promoting Interoperability reporting options for MIPS
eligible clinicians who participate in the Shared Savings Program.
Therefore, beginning in the 2019 MIPS performance period, we proposed
(83 FR 35935) to no longer apply the requirement as finalized at Sec.
414.1370(g)(4)(i) and instead to apply the existing policy at Sec.
414.1370(g)(4)(ii) to MIPS eligible clinicians who participate in the
Shared Savings Program so that they may report on the Promoting
Interoperability performance category at either the individual or group
level like all other MIPS eligible clinicians under the APM scoring
standard.
We solicited comment on this proposal.
The following is a summary of the public comments received on this
proposal and our responses:
Comment: Several commenters supported our proposed policy. One
commenter recommended that CMS allow reporting at the individual level
only when group-level information is not reported.
Response: We believe that by aligning Shared Savings Program
Promoting Interoperability scoring rules with those for the rest of
MIPS and MIPS APMs we will reduce confusion while creating
opportunities for individual MIPS eligible clinicians to contribute
positively to the total ACO Entity score in the event that a
participant TIN fails to report on this performance category.
Comment: One commenter requested that CMS maintain the current
requirement for ACO participant TIN-level reporting for Promoting
Interoperability performance category measures. The commenter noted
that although the proposed change increases flexibility, larger ACOs
may encounter difficulty managing the Promoting Interoperability
reporting for all of the individual MIPS eligible clinicians that bill
through TINs of ACO participants, risking a payment consequences for
failing to report.
Response: The Promoting Interoperability performance category may
be reported at either the individual or group level, not the APM Entity
(ACO) level; therefore, this policy change will increase MIPS eligible
clinicians' opportunities to report in the event that an ACO
participant TIN does not, but should not give rise to a scenario where
an ACO's performance category score would be negatively impacted. If
the participant TIN reports for the PI performance category, there
would be no need for the ACO to manage reporting for individual MIPS
eligible clinicians; if the TIN fails to report, the individual MIPS
eligible clincians within that TIN would have an opportunity to reduce
the negative impact of that failure by reporting individually.
After consideration of the comments received, we are finalizing the
proposal to allow MIPS eligible clinicians participating in the Shared
Savings Program to report on the Promoting Interoperability performance
category at either the individual or group level.
(e) MIPS APM Performance Feedback
As we discussed in the CY 2017 and 2018 Quality Payment Program
final rules (81 FR 77270, and 82 FR 53704 through 53705, respectively),
MIPS eligible clinicians who are scored under the APM scoring standard
will receive performance feedback under section 1848(q)(12) of the Act.
Regarding access to performance feedback, we should note that
whereas split-TIN APM Entities and their participants can only access
their performance feedback at the APM Entity or individual MIPS
eligible clinician level, MIPS eligible clinicians participating in the
Shared Savings Program, which is a full-TIN APM, will be able to access
their performance feedback at the ACO participant TIN level.
(f) Summary of Finalized Policies
In this section, we are finalizing the following policies:
MIPS APM Criteria:
We are modifying the MIPS APM criterion at Sec.
414.1370(b)(3) to state that the APM bases payment on performance
(either at the APM entity or eligible clinician level) on quality
measures and cost/utilization.
We are finalizing our clarification that we separately
evaluate to each distinct track of an APM to determine whether it meets
our criteria to be a MIPS APM. We note that this may result in an APM
having some tracks that are MIPS APMs and other tracks that are not
MIPS APMs.
We are finalizing our clarification of our interpretation
of the regulation at Sec. 414.1370(b)(4)(i). Therefore, we consider
the first performance year for an APM to begin as of the first date for
which eligible clinicians and APM entities participating in the model
must report on quality measures under the terms of the APM. We believe
that this will eliminate possibly conflicting incentives between the
quality scoring requirements and payment incentive structures under the
APM and MIPS and will reduce the likelihood of duplicative reporting of
quality information.
Final determinations of MIPS APMs for the 2019 MIPS
performance year will be made by CMS and announced on the QPP website
at https://qpp.cms.gov/. Further, in making these final determinations
for 2019, we will use the MIPS APM criteria established in Sec.
414.1370(b), taking into account the clarifications we are finalizing
in this final rule.
Complete Reporting Requirements:
We are finalizing our policy as proposed so that beginning
in 2019, if a Shared Savings Program ACO fails to report quality
measures as required by the Shared Savings Program we would also allow
a solo practitioner (a MIPS eligible clinician who has only one NPI
billing through their TIN), to report on any available MIPS measures,
including individual measures.
We are not finalizing our proposal to modify the complete
reporting requirement for Web Interface reporters so that, in the case
where a Shared Savings Program ACO fails to complete reporting for Web
Interface measures but successfully reports the CAHPS for ACOs survey,
we would apply the CAHPS for ACOs survey toward and APM Entity's
quality performance category score. Therefore, in the case where a
Shared Savings Program ACO fails to successfully report Web Interface
measures but does successfully report the CAHPS for ACOs survey, we
will continue to treat the ACO participant TINs as unique APM Entities
under the APM scoring standard and will score each TIN only on the MIPS
measures it has reported.
Promoting Interoperability Performance Category:
We are finalizing the proposal to allow MIPS eligible
clinicians participating in the Shared Savings

[[Page 59824]]

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category at either the individual or group level.
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Vol. 83

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No. 226

November 23, 2018

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We proposed to update the MIPS APM measure sets that apply for
purposes of the APM scoring standard (83 FR 35933 through 35934). The
following is a summary of the public comments received on these measure
sets and our responses:
Comment: Several commenters supported the measure sets set forth in
the proposed rule. Other commenters recommended additional measures to
be used in future years or suggested modifications to the measures
themselves.
Response: We thank the commenters for their support and note that,
consistent with Sec. 414.1370(g)(1)(i)(A) and (ii)(A), we are using
only measures that are included or that CMS intends to include in each
APM measures set at the time of publication of this final rule. Should
those measures be removed or revised from that measure set before the
end of the performance year, we will not score APM Entities on their
performance on those measures, but will include updated measures in
future rulemaking.
Per our policy expressed in last year's final rule (82 FR 53695 and
53696), the measure sets on the MIPS APM measure list for the year will
represent all possible measures which may contribute to an APM Entity's
MIPS score for the MIPS quality performance category, and may include
measures that are the same as or similar to those used by MIPS.
However, a given measure ultimately might not be used for scoring, for
example if its data becomes inappropriate or unavailable for scoring.
After consideration of the comments received, we are finalizing our
proposal to update the MIPS APM measure sets that apply for purposes of
the APM scoring standard and will score only measures that already have
been included in the measure sets of their given APM, according to the
terms of participation in that APM. We note that Table 48 has been
updated to reflect the most current APM measure sets.
i. MIPS Final Score Methodology
(1) Converting Measures and Activities Into Performance Category Scores
(a) Background
For the 2021 MIPS payment year, we intend to build on the scoring
methodology we finalized for the transition years, which allows for
accountability and alignment across the performance categories and
minimizes burden on MIPS eligible clinicians. The rationale for our
scoring methodology continues to be grounded in the understanding that
the MIPS scoring system has many components and various moving parts.
As we continue to move forward in implementing the MIPS program, we
strive to balance the statutory requirements and programmatic goals
with the ease of use, stability, and meaningfulness for MIPS eligible
clinicians. We do so while also emphasizing simplicity and the
continued development of a scoring methodology that is understandable
for MIPS eligible clinicians.

[[Page 59841]]

In the CY 2017 Quality Payment Program final rule, we finalized a
unified scoring system to determine a final score across the 4
performance categories (81 FR 77273 through 77276). For the 2019 MIPS
performance period, we proposed to build on the scoring methodology we
previously finalized, focusing on encouraging MIPS eligible clinicians
to meet data completeness requirements (83 FR 35948 through 35949). For
quality performance category scoring, we proposed to extend some of the
transition year policies to the 2019 MIPS performance period, and we
also proposed several modifications to existing policies (83 FR 35947
through 35949). In the CY 2018 Quality Payment Program final rule (82
FR 53712 through 53714), we established a methodology for scoring
improvement in the cost performance category. However, as required by
section 51003(a)(1)(B) of the Bipartisan Budget Act of 2018, we
proposed that the cost performance category score would not take into
account improvement until the 2024 MIPS payment year (83 FR 35956). In
the CY 2018 Quality Payment Program final rule (82 FR 53753 through
53767), we finalized the availability of a facility-based measurement
option for clinicians who met certain requirements, beginning with the
2019 MIPS performance period. As discussed in section III.I.3.i.(1)(d)
of this final rule, we are finalizing our proposal to change the
determination of facility-based measurement to include consideration of
presence in the on-campus outpatient hospital. The policies for scoring
the 4 performance categories are described in detail in section
III.I.3.i.(1) of this final rule.
These policies will help eligible clinicians as they participate in
the 2019 MIPS performance period/2021 MIPS payment year, and as we move
beyond the transition years of the program. Section 51003 of the
Bipartisan Budget Act of 2018 provides flexibility to continue the
gradual ramp up of the Quality Payment Program and enables us to extend
some of the transition year policies to the 2019 performance period.
Unless otherwise noted, for purposes of this section III.I.3.i. of
this final rule, the term ``MIPS eligible clinician'' will refer to
MIPS eligible clinicians who collect and submit data and are scored at
either the individual or group level, including virtual groups; it will
not refer to MIPS eligible clinicians who are scored by facility-based
measurement, as discussed in section III.I.3.i.(1)(d) of this final
rule. We also note that the APM scoring standard applies to MIPS
eligible clinicians in APM Entities in MIPS APMs, and those policies
take precedence where applicable. Where those policies do not apply,
scoring for MIPS eligible clinicians as described in section
III.I.3.h.(6) of this final rule will apply. We refer readers to
section III.I.4. of this final rule for additional information about
the APM scoring standard.
(b) Scoring the Quality Performance Category for the Following
Collection Types: Part B Claims Measures, eCQMs, MIPS CQMs, QCDR
Measures, CMS Web Interface Measures, the CAHPS for MIPS Survey Measure
and Administrative Claims Measures
Although we did not propose changing the basic scoring system that
we finalized in the CY 2018 Quality Payment Program final rule for the
2021 MIPS payment year (82 FR 53712 through 53748), we proposed several
modifications to scoring the quality performance category, including
removing high-priority measure bonus points for CMS Web Interface
measures and extending the bonus point caps, and adding a small
practice bonus to the quality performance category score. The following
section describes these previously finalized policies and our proposals
(83 FR 35950 through 35952).
We also proposed updates to Sec. 414.1380(b)(1) in an effort to
more clearly and concisely capture previously established policies (83
FR 35946 through 35955). These proposed updates are not intended to be
substantive in nature, but rather to bring more clarity to the
regulatory text. We will make note of the updated regulatory citations
in their relevant sections below.
(i) Scoring Terminology
In the CY 2017 and CY 2018 Quality Payment Program final rules (81
FR 77008 through 77831 and 82 FR 53568 through 54229, respectively), we
used the term ``submission mechanisms'' in reference to the various
ways in which a MIPS eligible clinician or group can submit data to
CMS. As discussed in section III.I.3.h.(1)(b) of this final rule, it
has come to our attention that the way we have described the various
ways in which MIPS eligible clinicians, groups and third-party
intermediaries can submit data to our systems does not accurately
reflect the experience users have when submitting data to us. We refer
readers to section III.I.3.h.(1)(b) of this final rule for further
discussion on our finalized changes to the scoring terminology related
to measure specification and data collection and submission. For
additional discussion on the impact of the proposed terminology change
on our benchmarking methodology, validation process, and end-to-end
reporting bonus, we refer readers to sections III.I.3.i.(1)(b)(ii),
(v), and (x) of this final rule.
(ii) Quality Measure Benchmarks
We refer readers to the CY 2017 and CY 2018 Quality Payment Program
final rules (81 FR 77282 and 82 FR 53718, respectively) for our
previously established benchmarking policies. As part of our proposed
technical updates to Sec. 414.1380(b)(1) discussed in section
III.I.3.i.(1)(a)(i) of this final rule, our previously established
benchmarking policies at Sec. 414.1380(b)(1)(i) through (iii) would
now be referenced at Sec. 414.1380(b)(1)(i) through (ii).
When we developed the quality measure benchmarks, we sought to
develop a system that enables MIPS eligible clinicians, beneficiaries,
and other stakeholders to understand what is required for a strong
performance in MIPS while being consistent with statutory requirements
(81 FR 28249 through 28250). The feedback we have received thus far
from stakeholders on our benchmarks is helping to inform our approach
to the benchmarking methodology, especially as we look for possible
ways of aligning with Physician Compare benchmarks. As described in
section III.I.3.i.(1)(b)(xii) of this final rule, we solicited comment
on potential future approaches to scoring the quality performance
category to continue to promote value and improved outcomes.
We anticipate changes in scoring would be paired with potential
modifications to measure selection and criteria discussed in section
III.I.3.h.(2)(b) of this final rule. In the CY 2019 PFS proposed rule
(83 FR 35947), we sought input on opportunities to further reduce
confusion about our benchmarking methodology described in the CY 2017
Quality Payment Program final rule (81 FR 77277 through 77278), which
includes further clarification of our benchmarking process and
potential areas of alignment between the MIPS and Physician Compare
benchmarking methodologies.
We thank commenters for their input and may take this input into
consideration in future years.
(A) Revised Terminology for MIPS Benchmarks
We previously established at Sec. 414.1380(b)(1)(iii) separate
benchmarks for the following submission mechanisms: EHR; QCDR/registry,
claims; CMS Web Interface; CMS-approved survey vendor; and
administrative claims. In the CY 2019

[[Page 59842]]

PFS proposed rule, we did not propose to change our basic approach to
our benchmarking methodology; however, we proposed to amend Sec.
414.1380(b)(1)(ii) consistent with the proposed data submission
terminology changes discussed in section III.I.3.h.(1)(b) of this final
rule (83 FR 35947). Specifically, beginning with the 2021 MIPS payment
year, we proposed to establish separate benchmarks for the following
collection types: eCQMs; QCDR measures (as described at Sec.
414.1400(e)); MIPS CQMs; Medicare Part B claims measures; CMS Web
Interface measures; the CAHPS for MIPS survey; and administrative
claims measures. We would apply benchmarks based on collection type
rather than submission mechanism. For example, for an eCQM, we would
apply the eCQM benchmark regardless of submitter type (MIPS eligible
clinician, group, third party intermediary). In addition, we would
establish separate benchmarks for QCDR measures and MIPS CQMs since
these measures do not have comparable specifications. In addition, we
note that our proposed benchmarking policy allows for the addition of
future collection types as the universe of measures continues to evolve
and as new technology is introduced. Specifically, we proposed to amend
Sec. 414.1380(b)(1)(ii) to remove the mention of each individual
benchmark and instead state that benchmarks will be based on collection
type, from all available sources, including MIPS eligible clinicians
and APMs, to the extent feasible, during the applicable baseline or
performance period.
The following is a summary of the public comments on these
proposals and our responses:
Comment: A few commenters expressed support for our proposal to
establish separate benchmarks by collection types, citing the
difference in measure performance across collection types. One
commenter stated this update would maintain consistency when migrating
between current MIPS terminology to proposed MIPS terminology.
Response: We thank commenters for their support as we continue to
clarify and improve our benchmarking policies.
Comment: One commenter expressed concern about the proposal to
update our regulatory text to state that benchmarks are based on
collection types from all available sources, including APMs.
Specifically, the commenter noted that incorporating APM data into
benchmark calculations will set the benchmarks too high since APM
participants tend to be high performers.
Response: We recognize commenter's concern; however, this is not a
new policy, and we refer readers to the CY 2017 Quality Payment Program
final rule (81 FR 77279) for additional discussion on the inclusion of
APMs in the MIPS benchmarks. As measures and technology evolve, we are
constantly reviewing and evaluating what data sources are appropriate
for benchmarks.
Comment: One commenter requested clarification on whether QCDR
measures that have an e-specified collection type and a manual
collection type will also be considered separate collection types with
distinct benchmarks.
Response: We expect that a QCDR measure for which data is
abstracted through EHRs or manually (that is, paper records) would have
to be approved as two separate measures. As a result, each measure
would only be compared to its own benchmark.
After consideration of public comments, we are finalizing our
proposal, beginning with the 2021 MIPS payment year, to amend Sec.
414.1380(b)(1)(ii) to establish separate benchmarks based on collection
type and to remove the mention of each individual benchmark and state
that benchmarks will be based on collection type, from all available
sources, including MIPS eligible clinicians and APMs, to the extent
feasible, during the applicable baseline or performance period.
(iii) Assigning Points Based on Achievement
In the CY 2017 Quality Payment Program final rule, we established
the policies for scoring quality measures performance (81 FR 77286). We
refer readers to Sec. 414.1380(b)(1) for more on these policies.
(A) Floor for Scored Quality Measures
For the 2019 and 2020 MIPS payment years, we finalized at Sec.
414.1380(b)(1)(i) a global 3-point floor for each scored quality
measure, as well as for the hospital readmission measure (if
applicable). In this way, MIPS eligible clinicians would receive
between 3 and 10 measure achievement points for each submitted measure
that can be reliably scored against a benchmark, which requires meeting
the case minimum and data completeness requirements (81 FR 77286
through 77287; 82 FR 53719). For measures with a benchmark based on the
performance period (rather than on the baseline period), we stated that
we would continue to assign between 3 and 10 measure achievement points
for performance periods after the first transition year (81 FR 77282,
77287; 82 FR 53719). For measures with benchmarks based on the baseline
period, we stated that the 3-point floor was for the transition year
and that we would revisit the 3-point floor in future years (81 FR
77286 through 77287; 82 FR 53719).
For the 2021 MIPS payment year, we proposed to again apply a 3-
point floor for each measure that can be reliably scored against a
benchmark based on the baseline period, and to amend Sec.
414.1380(b)(1)(i) accordingly (83 FR 35947). We will revisit the 3-
point floor for such measures again in future rulemaking.
We requested comments on the proposal above. These comments and our
responses are discussed below.
Comment: Several commenters expressed support for the three-point
floor for measures that can be reliably scored against a benchmark
based on the baseline period because it would reduce confusion, help
reduce burden, maintain stability, and encourage physicians to continue
to participate in MIPS.
Response: We thank commenters for their support.
After consideration of public comments, we are finalizing our
proposal, for the 2021 MIPS payment year, to apply a 3-point floor for
each measure that can be reliably scored against a benchmark, and to
amend Sec. 414.1380(b)(1)(i) accordingly.
(B) Additional Policies for the CAHPS for MIPS Measure Score
Although participating in the CAHPS for MIPS survey is optional for
all groups, some groups will be unable to participate in the CAHPS for
MIPS survey because they do not meet the minimum beneficiary sampling
requirements. CMS has sampling requirements for groups of 100 or more
eligible clinicians, 25 to 99 eligible clinicians, and 2 to 24 eligible
clinicians to ensure an adequate number of survey responses and the
ability to reliably report data. Our sampling timeframes necessitate
notifying groups of their inability to meet the sampling requirements
late in the performance period (see 82 FR 53630 through 53632). As a
result, we are concerned that some groups that expect and plan to meet
the quality performance category requirements using the CAHPS for MIPS
survey may find out late in the performance period that they are unable
to meet the sampling requirements and, therefore, are unable to have
their performance assessed on this measure. These groups may need to
report on another measure to meet the

[[Page 59843]]

requirements of the quality performance category.
We want to encourage the reporting of the CAHPS for MIPS survey and
do not want the uncertainty regarding sampling requirements to be a
barrier to selecting the CAHPS for MIPS survey. To mitigate this
concern, beginning with the 2021 MIPS payment year, we proposed to
reduce the denominator (that is, the total available measure
achievement points) for the quality performance category by 10 points
for groups that register for the CAHPS for MIPS survey but do not meet
the minimum beneficiary sampling requirements (83 FR 35948). By
reducing the denominator instead of only assigning the group a score of
zero measure achievement points (because the group would be unable to
submit any CAHPS for MIPS survey data), we are effectively removing the
impact of the group's inability to submit the CAHPS for MIPS survey. We
believe this reduction in denominator would remove any need for groups
to find another measure if they are unable to submit the CAHPS for MIPS
survey. Therefore, we proposed to amend Sec. 414.1380 to add paragraph
(b)(1)(vii)(B) to state that we will reduce the total available measure
achievement points for the quality performance category by 10 points
for groups that registered for the CAHPS for MIPS survey but do not
meet the minimum beneficiary sampling requirements.
We requested comments on the proposal above. These comments and our
responses are discussed below.
Comment: Several commenters supported our proposed policy. One
commenter believes this will encourage more groups to conduct the
survey.
Response: We appreciate the commenters' support.
Comment: One commenter requested clarification on when groups would
be notified that they did not meet the beneficiary sampling
requirement. The commenter also requested clarification on what
protections the agency will institute for groups who must cancel their
contracts with survey vendors ``late in the performance period'' when
they are notified that they did not meet the beneficiary sampling
requirement. The commenter stated that CMS should not hold groups
accountable for vendor costs that result from the agency's late
notification process.
Response: We do not anticipate the notification process for minimum
beneficiary sample requirements will change. CMS provides information
on sample design and sample size requirements in the QPP Resource
Library to aid groups in deciding whether or not to elect CAHPS for
MIPS. CMS sends communication about sample size eligibility to the
point of contact provided by each group during the registration process
for CAHPS for MIPS. Providing more than one point of contact will help
to promote timely delivery of the information on sample size
eligibility to the group. Groups should coordinate with their vendors
to address any questions regarding costs in the event the group does
not meet the beneficiary sampling requirement. For any additional
questions please visit the Quality Payment Program website at
qpp.cms.gov.
Comment: One commenter sought clarification whether CMS would
automatically apply the scoring policy or first provide groups with the
option to report on an alternate quality measure or improvement
activity.
Response: We will not automatically apply the scoring policy.
Notifications will be sent twice to groups that have registered for the
CAHPS for MIPS survey and who have an insufficient sample size, with
the second notification usually occurring in September. These
notifications also encourage groups to select other relevant measures
that can be completed. We believe that this policy is necessary because
the notification late in the performance period might not allow
sufficient time for groups to collect and report a different quality
measure, however, some practices may have other quality measures
(beyond the 6 minimum) that they have been reporting on that could be
submitted within the performance period. For groups that submitted 5 or
fewer quality measures and do not meet the CAHPS for MIPS sampling
requirements, the quality denominator will be reduced by 10 points. For
groups that submitted 6 or more quality measures and do not meet the
CAHPS for MIPS sampling requirements, we will score the 6 measures with
the highest achievement points.
The notification will also encourage groups to select other
relevant improvement activities that can be completed within the
performance period. We refer readers to section III.I.3.h.(4)(b) of
this final rule for further information on submission criteria for the
improvement activities performance category.
After consideration of public comments, we are finalizing our
proposal to amend Sec. 414.1380 to add paragraph (b)(1)(vii)(B) to
state that we will reduce the total available measure achievement
points for the quality performance category by 10 points for groups
that submit 5 or fewer quality measures and register for the CAHPS for
MIPS survey, but do not meet the minimum beneficiary sampling
requirements.
We do not want groups to register for the CAHPS for MIPS survey if
they know in advance that they are unlikely to be able to meet the
sampling requirement, so we solicited comments on whether we should
limit this proposed policy to groups for only one MIPS performance
period. For example, for the performance period following the
application of this proposed policy, a notice could be provided to
groups during registration indicating that if the sampling requirement
is not met for a second consecutive performance period, the proposed
policy will not be applied. This would provide notice to the group that
they may not meet the sampling requirement needed for the CAHPS for
MIPS survey and may need to look for alternate measures but does not
preclude the group from registering for the CAHPS for MIPS survey if
they expect to meet the minimum beneficiary sampling requirements in
the second MIPS performance period.
We thank commenters for their suggestions and may consider them for
future rulemaking.
(iv) Assigning Measure Achievement Points for Topped Out Measures
We refer readers to CY 2017 Quality Payment Program final rule (82
FR 53721 through 53727) for our established policies for scoring topped
out measures.
Under Sec. 414.1380(b)(1)(xiii)(A), for the 2020 MIPS payment
year, 6 measures will receive a maximum of 7 measure achievement
points, provided that the applicable measure benchmarks are identified
as topped out again in the benchmarks published for the 2018 MIPS
performance period. Under Sec. 414.1380(b)(1)(xiii)(B), beginning with
the 2021 MIPS payment year, measure benchmarks (except for measures in
the CMS Web Interface) that are identified as topped out for 2 or more
consecutive years will receive a maximum of 7 measure achievement
points beginning in the second year the measure is identified as topped
out (82 FR 53726 through 53727). As part of our technical updates to
Sec. 414.1380(b)(1) outlined in section III.I.3.i.(1)(b) of this final
rule, our previously finalized topped out scoring policies are now
referenced at Sec. 414.1380(b)(1)(iv).
We refer readers to the 2018 MIPS Quality Benchmarks' file that is
located on the Quality Payment Program resource library (https://www.cms.gov/Medicare/Quality-Payment-Program/Resource-Library/Resource-library.html) to determine which measure

[[Page 59844]]

benchmarks are topped out for 2018 and would be subject to the cap if
they are also topped out in the 2019 MIPS Quality Benchmarks' file. We
note that the final determination of which measure benchmarks are
subject to the topped out cap will not be available until the 2019 MIPS
Quality Benchmarks' file is released in late 2018.
We did not propose to apply our previously finalized topped out
scoring policy to the CAHPS for MIPS survey (82 FR 53726). Because the
CAHPS for MIPS survey was revised in 2018 (82 FR 53632), we do not have
historical benchmarks for the 2018 performance period, so the topped
out policy would not be applied for the 2019 performance period. Last
year, we received limited feedback when we sought comment on how the
topped out scoring policy should be applied to CAHPS for MIPS survey.
In CY 2019 PFS proposed rule, we sought feedback on potential ways we
can score CAHPS for MIPS Summary Survey Measures (SSM) (83 FR 35948).
For example, we could score all SSMs, which means there would
effectively be no topped out scoring for CAHPS for MIPS SSMs, or we
could cap the SSMs that are topped out and score all other SSMs. We
sought comment on these approaches and additional approaches to the
topped out scoring policy for CAHPS for MIPS SSMs. We noted that we
encourage groups to report the CAHPS for MIPS survey as it incorporates
beneficiary feedback.
We thank commenters for their suggestions and will consider them
for future rulemaking.
(v) Scoring Measures That Do Not Meet Case Minimum, Data Completeness,
and Benchmarks Requirements
In the CY 2017 Quality Payment Program final rule (81 FR 77288
through 77289), we established scoring policies for a measure that is
submitted but is unable to be scored because it does not meet the
required case minimum, does not have a benchmark, or does not meet the
data completeness requirement. As part of our technical updates to
Sec. 414.1380(b)(1) discussed in section III.I.3.i.(1)(b) of this
final rule, our previously finalized scoring policies are now
referenced at Sec. 414.1380(b)(1)(i)(A) and (B).
A summary of the current and proposed policies is provided in Table
50. For more of the statutory background and details on current
policies, we refer readers to the CY 2017 and CY 2018 Quality Payment
Program final rules (81 FR 77288 through 77289 and 82 FR 53727 through
53730, respectively).
[GRAPHIC] [TIFF OMITTED] TR23NO18.065

As the MIPS program continues to mature, we are looking to find
ways to improve our policies, including what to do with measures that
do not meet the case minimum. Although many MIPS eligible clinicians
can meet the 20-case minimum requirement, we recognize that small
practices and individual MIPS eligible clinicians may have difficulty
meeting this standard. Although we process data from the CY 2017 MIPS
performance period to determine how often submitted measures do not
meet case minimums, we invited public comment on ways we can improve
our case-minimum policy. In determining future improvements to our case
minimum policy, our goal is to

[[Page 59845]]

balance the concerns of MIPS eligible clinicians who are unable to meet
the case minimum requirement and for whom we cannot capture enough data
to reliably measure performance, while not creating incentives for MIPS
eligible clinicians to choose measures that do not meet case minimum
even though other more relevant measures are available.
We thank commenters for their suggestions and will consider them
for future rulemaking.
In the CY 2019 PFS proposed rule (83 FR 35949), we proposed to
maintain the policies finalized for the CY 2018 MIPS performance period
regarding measures that do not meet the case-minimum requirement, do
not have a benchmark, or do not meet the data-completeness criteria for
the CY 2019 MIPS performance period, and to amend Sec.
414.1380(b)(1)(i) accordingly.
We also proposed to assign zero points for measures that do not
meet data completeness starting with the CY 2020 MIPS performance
period and to amend Sec. 414.1380(b)(1)(i)(B)(1) accordingly (83 FR
35949). This policy is part of our effort to move toward complete and
accurate reporting that reflects meaningful effort to improve the
quality of care that patients receive. Measures submitted by small
practices would continue to receive 3 points for all future CY MIPS
performance periods, although we may revisit this policy through future
rulemaking.
We requested comments on the proposals above. These comments and
our responses are discussed below.
Comment: Several commenters supported the proposal to maintain the
policies finalized for the CY 2018 MIPS performance period regarding
measures that do not meet the case minimum requirement, do not have a
benchmark, or do not meet the data-completeness criteria for the CY
2019 MIPS performance period.
Response: We thank commenters for their support. However, we want
to stress that these policies were not meant to be permanent and as
clinicians continue to gain experience with the program we will revisit
the appropriateness of these policies in future rulemaking.
Comment: A few commenters did not support our proposal to reduce
points for measures that do not meet data completeness to zero starting
with the CY 2020 MIPS performance period because of concerns that it
would add complexity and burden as clinicians are continuing to learn
the program. A few commenters suggested that CMS should return to
assigning these measures 3 points or, at a minimum, continue to assign
them 1 point or provide special scoring for MIPS eligible clinicians
with significant administrative burdens. A few commenters recommended
that clinicians should at least get some credit for attempting to
report and, through no fault of their own, fail to meet the data
completeness threshold, citing the difficulty of getting all the
necessary data from hospitals and/or their billing companies to report
on 60 percent of all applicable patients.
Response: We understand and recognize commenters' concerns.
However, as the program is being fully implemented, we want to ensure
that our policies align with our goal of improving quality. This
scoring policy was intended to be temporary, and we believe that data
completeness is something that is within the direct control of
clinicians. Although we understand that many clinicians have
administrative burdens and we continuously strive to reduce paperwork,
we also believe that it is important to develop policies that align
with the program's goal to improve quality of care. By the fourth year
of implementation, we believe this policy is no longer needed and that
removing this policy helps streamline our scoring policies.
After consideration of public comments, we are finalizing the
proposal to maintain the policies finalized for the CY 2018 MIPS
performance period regarding measures that do not meet the case-minimum
requirement, do not have a benchmark, or do not meet the data-
completeness criteria for the CY 2019 MIPS performance period, and the
amending of Sec. 414.1380(b)(1)(i) accordingly.
After consideration of public comments, we are finalizing our
proposal to assign zero points for measures that do not meet data
completeness starting with the CY 2020 MIPS performance period and to
amend Sec. 414.1380(b)(1)(i)(B)(1) accordingly. Measures submitted by
small practices will continue to receive 3 points for all future MIPS
performance periods.
(vi) Scoring Flexibility for Measures With Clinical Guideline Changes
During the Performance Period
In the CY 2018 Quality Payment Program final rule (82 FR 53714
through 53716), we finalized that, beginning with the 2018 MIPS
performance period, we will assess performance on measures considered
significantly impacted by ICD-10 updates based only on the first 9
months of the 12-month performance period (for example, January 1,
2018, through September 30, 2018, for the 2018 MIPS performance
period). We noted that performance on measures that are not
significantly impacted by changes to ICD-10 codes would continue to be
assessed on the full 12-month performance period (January 1 through
December 31). Lastly, we finalized that we will publish the list of
measures requiring a 9-month assessment process on the CMS website by
October 1st of the performance period if technically feasible, but by
no later than the beginning of the data submission period (for example,
January 2, 2019, for the 2018 MIPS performance period). As part of our
technical updates to Sec. 414.1380(b)(1) outlined in section
III.I.3.i.(1)(b) of this final rule, these previously finalized
policies are now referenced at Sec. 414.1380(b)(1)(viii).
We remain concerned about instances where clinical guideline
changes or other changes to evidence supporting a measure occur during
the performance period that may significantly impact a measure.
Clinical guidelines and protocols developed by clinical experts and
specialty medical societies often underpin quality measures. At times,
measure stewards must amend quality measures to reflect new research
and changed clinical guidelines, and sometimes, as a result of the
change in these guidelines, adherence to guidelines in the existing
measures could result in patient harm or otherwise provide misleading
results as to good quality care. We sought comment in the CY 2018
Quality Payment Program final rule regarding whether we should apply
scoring flexibility to measures significantly impacted by clinical
guideline changes (82 FR 53716). We refer readers to the CY 2019 PFS
proposed rule for a summary of the comments we received (83 FR 35949
through 35950).
We remain concerned that findings of evidence-based research,
providing the basis for sound clinical practice guidelines and
recommendations that are the foundation of a quality measure, may
change outside of the rulemaking cycle. As the clinical evidence and
guidelines change, approved measures may no longer reflect the most up-
to-date clinical evidence and could be contrary to patient well-being.
There may be instances in which changes to clinical guidelines are so
significant, that an expedited review is needed outside of the
rulemaking cycle because measures may result in a practice that is
harmful to patients. To further align with policies adopted within
other value based programs such as the Hospital VBP Program (83 FR
20409), we proposed to suppress a measure without rulemaking, if during
the performance period a measure is

[[Page 59846]]

significantly impacted by clinical guideline changes or other changes
that CMS believes may pose patient safety concerns (83 FR 35950). We
would rely on measure stewards for notification in changes to clinical
guidelines. We will publish on the CMS website suppressed measures
whenever technically feasible, but by no later than the beginning of
the data submission period.
In the CY 2019 PFS proposed rule (83 FR 35950), we proposed
policies to provide scoring flexibility in the event that we need to
suppress a measure during a performance period. Scoring for a
suppressed measure would result in a zero achievement points for the
measure and a reduction of the total available measure achievement
points by 10 points. We believe that this approach effectively removes
the impact of the eligible clinician's inability to receive measure
achievement points for the measure, if a submitted measure is later
suppressed.
We also proposed to add a new paragraph at Sec.
414.1380(b)(1)(vii) that, beginning with the 2019 MIPS performance
period, CMS will reduce the total available measure achievement points
for the quality performance category by 10 points for MIPS eligible
clinicians that submit a measure significantly impacted by clinical
guideline changes or other changes that CMS believes may pose patient
safety concerns (83 FR 35950).
We requested comments on the proposal above. These comments and our
responses are discussed below.
Comment: A few commenters supported the proposal because it holds
the clinician harmless from clinical guideline changes that impact
quality measures. One commenter noted that it is important that
clinicians are protected from any adverse impacts on their scoring when
they are following updated clinical guidelines to ensure proper patient
care and safety.
Response: We appreciate the support of the proposal.
Comment: Several commenters did not support the proposal.
Commenters questioned whether there would be an expectation that the
clinician would continue collecting data on the measure, or whether
they would be allowed to submit the measure with less than 12 months'
data for the suppressed measure. A few commenters stated the policy
should only be applied if the clinical guideline change relates to
patient harm or patient safety, in which case data collection on the
quality measure should cease immediately. A few commenters indicated
that clinicians invest significant time and resources to assess and
improve their performance over the course of the performance period,
and thus suppressing the scoring of a quality measure, unless patient
harm is involved, does not appropriately recognize these efforts. One
commenter suggested that CMS establish an attestation process through
the EIDM system to allow clinicians the option to attest their intent
to report the measure, and CMS should adjust their scoring accordingly.
Response: We appreciate the commenters' suggestions. There are rare
instances in which changes to clinical knowledge and guidelines can
significantly impact measure specifications and the intent of the
measure, which we believe requires suppression of scoring so as to
encourage the clinicians to follow the guidelines that are best for the
patient, rather than tracking the guidelines that were finalized in the
measure set, which may negatively impact patient care. Clinical
guideline changes that occur between rulemaking cycles would need to be
significant enough that the change in the most up-to-date clinical
evidence could result in patient harm if the clinician does not follow
these new guidelines or otherwise provide misleading results as to what
is measured as good quality care. We believe there are rare instances
in which we should not delay our support of the use of the most current
clinical evidence by continuing to require the collection of data and
scoring the measure until the next rulemaking cycle. For example, a
guideline may be updated because clinical evidence indicates that a new
medication should replace a medication specified in a quality measure.
If this occurs between rulemaking cycles, we would not want the scoring
policy to disadvantage the clinicians adopting the updated guideline
and using the recommended medication. We envision that this policy
would be applied in two circumstances. First, there is a newly issued
or updated guideline where there is wide consensus that would result in
a significant change to a quality measure. In these cases, it would be
expected that clinicians would adopt clinical processes to support the
new guideline which may not be compatible with the existing measures
and could provide misleading results or patient harm. In this case, we
anticipate the quality measure would be reviewed and updated during the
next rulemaking process. Second, we envision using this policy in rare
cases where there is a new or revised guideline, even if there is no
broad consensus within the specialty, because some clinicians will
begin to adopt the new guideline which would not be consistent with the
quality measures and scoring the measure could cause misleading results
for those clinicians. We believe it important to suppress the measure
until guideline and quality measure are reviewed by the Measures
Application Partnership (MAP) and other processes to support the Annual
List of Measures, including rulemaking. We do not envision using this
policy solely based on indications that guideline revisions are
anticipated but not completed. Until the guideline is updated,
clinicians would be expected to follow the existing guideline and it
would not be prudent to use the scoring policy. Nor would we activate
the policy if the guideline change does not significantly impact the
measure results.
In the event of the need for the special scoring policy, we would
communicate to clinicians through multiple channels regarding the
changes. We appreciate that clinicians invest significant time and
resources to select measures, we also believe it is critical that the
measure results do not cause patient harm or otherwise harm clinician
performance by scoring potentially misleading data. We believe
suppressing the measure and reducing the total possible achievement
points by 10 would recognize this effort by not forcing clinicians in
the middle of a performance to select a new measure to report.
We appreciate the time and resources clinicians expend to collect
data for a quality measure; however, we believe the policy will only be
used in rare occasions, which will limit disruption to clinicians. We
also believe that the policy will not disadvantage the clinician and
will ``hold harmless'' any clinician submitting data on the measure.
Scoring would be suppressed for any clinician that submitted data on
the measure prior to the announcement. Similarly, given how rarely we
anticipate we will need to use this policy, we do not believe we
require a process for attestation regarding which measures will be
selected prior to the performance period.
Comment: A few commenters recommended regular communication between
CMS and measure stewards and supported the proposal that it would be
the responsibility of the measure steward to notify CMS of changes to
the clinical guidelines that may impact existing quality measures. One
commenter requested that CMS allow multiple sources, rather than just
measure stewards, to identify potential significant changes to clinical
guidelines that may pose patient safety

[[Page 59847]]

risks. Another commenter stated that only measure stewards should
notify CMS of significant changes to clinical guidelines.
Response: We regularly monitor changes to quality measures and work
closely with clinical organizations that maintain clinical guidelines
and measure stewards to identify quality measures impacted by
significant changes to clinical guidelines during the performance
period. We will mainly rely on measure stewards to identify significant
changes, especially those relating to potential patient harm. We
clarify that measure stewards are not necessarily the owner and/or
developer of the clinical guidelines. In many instances measure
stewards defer to the clinical organizations or stakeholders who own,
maintain and update the clinical guideline when changes are warranted.
We intend to continue to work collaboratively with measure stewards,
clinical organizations, measure owners and other key stakeholders
responsible for the maintenance of these guidelines prior to deciding
to suppress the scoring of a measure. As noted above, if we decide to
suppress these measures, we would notify clinicians through multiple
means.
After consideration of public comments, we are finalizing a
modification of our proposal and adding a new paragraph at Sec.
414.1380(b)(1)(vii) stating that, beginning with the 2021 MIPS payment
year, we will reduce the denominator of available measure achievement
points for the quality performance category by 10 points for MIPS
eligible clinicians for each measure submitted that is significantly
impacted by clinical guideline changes or other changes when we believe
adherence to the guidelines in the existing measures could result in
patient harm or otherwise provide misleading results as to good quality
care. To clarify, we regularly monitor changes to quality measures and
clinical guidelines and we will rely mainly on measure stewards, who
often defer to the clinical organizations or other stakeholders who
own, maintain and update the clinical guideline when a guideline change
is warranted, for notification in changes to clinical guidelines. We
will publish on the CMS website suppressed measures whenever
technically feasible, but by no later than the beginning of the data
submission period.
(vii) Scoring for MIPS Eligible Clinicians That Do Not Meet Quality
Performance Category Criteria
In the CY 2018 Quality Payment Program final rule (82 FR 53732), we
finalized that, beginning with the 2021 MIPS payment year, we will
validate the availability and applicability of quality measures only
with respect to the collection type that a MIPS eligible clinician
utilizes for the quality performance category for a performance period,
and only if a MIPS eligible clinician collects via claims only, MIPS
CQMs only, or a combination of MIPS CQMs and claims collection types.
We will not apply the validation process to any data collection type
that the MIPS eligible clinician does not utilize for the quality
performance category for the performance period. We sought comment on
how to modify the validation process for the 2021 MIPS payment year
when clinicians may submit measures collected via multiple collection
types.
As discussed in section III.I.3.h.(1)(b) of this final rule, we
proposed to revise our terminology regarding data submission. This
updated terminology will more accurately reflect our current
submissions and validation policies. In the CY 2019 PFS proposed rule
(83 FR 35950), we proposed to modify our validation process to provide
that it only applies to MIPS CQMs and the claims collection type,
regardless of the submitter type chosen. For example, this policy would
not apply to eCQMs even if they are submitted by a registry.
We note that a MIPS eligible clinician may not have available and
applicable quality measures. If we are unable to score the quality
performance category, then we may reweight the clinician's score
according to the reweighting policies described in sections
III.I.3.i.(2)(b)(ii) and III.I.3.i.(2)(b)(iii) of this final rule.
We did not receive any comments on this proposal.
We are finalizing our proposal to modify our validation process to
provide that it only applies to MIPS CQMs and the claims collection
type, regardless of the submitter type chosen.
(viii) Small Practice Bonus
In the CY 2018 Quality Payment Program final rule (82 FR 53788), we
finalized at Sec. 414.1380(c)(4) to add a small practice bonus of 5
points to the final score for the 2020 MIPS payment year for MIPS
eligible clinicians, groups, APM Entities, and virtual groups that meet
the definition of a small practice as defined at Sec. 414.1305 and
submit data on at least one performance category in the 2018 MIPS
performance period.
We continue to believe an adjustment for small practices is
generally appropriate due to the unique challenges small practices
experience related to financial and other resources, as well as the
performance gap we have observed (based on historical PQRS data) for
small practices in comparison to larger practices. We believe a small
practice bonus specific to the quality performance category is
preferable for the 2021 MIPS payment year and future years. We believe
it is appropriate to apply a small practice bonus points to the quality
performance category based on observations using historical data, which
indicates that small practices are less likely to submit quality
performance data, less likely to report as a group and use the CMS Web
Interface, and more likely to have lower performance rates in the
quality performance category than other practices. We want the final
score to reflect performance, rather than the ability and
infrastructure to support submitting quality performance category data.
We considered whether we should continue to apply the small
practice bonus through bonus points in all 4 performance categories,
but believe the need for doing so is less compelling. The improvement
activities performance category already includes special scoring for
small practices (please refer to Sec. 414.1380(b)(3) and see section
III.I.3.i.(1)(e) of this final rule for more information). In addition,
for the Promoting Interoperability performance category, small
practices can apply for a significant hardship exception if they have
issues acquiring an EHR (see section III.I.3.h.(5) of this final rule).
Finally, the cost performance category does not require submission of
any data; therefore, there is less concern about a small practice being
burdened by those requirements. For these reasons, we proposed to
transition the small practice bonus to the quality performance
category.
Starting with the 2021 MIPS payment year, we proposed at Sec.
414.1380(b)(1)(v)(C) to add a small practice bonus of 3 points in the
numerator of the quality performance category for MIPS eligible
clinicians in small practices if the MIPS eligible clinician submits
data to MIPS on at least 1 quality measure (83 FR 35950). Because MIPS
eligible clinicians in small practices are not measured on the
readmission measure and are not able to participate in the CMS Web
Interface, they generally have a quality performance category
denominator of 60 total possible measure achievement points. Thus, our
proposal of 3 measure bonus points generally represents 5 percent of
the quality performance category score. As described in section
III.I.3.i.(2)(b)(iii) of this final rule, for clinicians in many small
practices, the

[[Page 59848]]

quality performance category weight may be up to 85 percent of the
final score. (For example, if a small practice applies for the
Promoting Interoperability significant hardship application and does
not meet the sufficient case minimum for cost measures, then the
weights of Promoting Interoperability and cost performance categories
are redistributed to quality and the quality performance category
weight would be 85 percent.)
With a weight of 85 percent, a small practice bonus of 3 points
added to the quality performance category will result in 4.25 bonus
points added to the final score for clinicians in small practices.\29\
We believe this is appropriate because it is similar to the impact of
the small practice bonus we finalized for the 2020 MIPS payment year (5
points added to the final score). Although we recognize that the impact
of the small practice bonus for MIPS eligible clinicians in small
practices who do not receive reweighting for the cost and/or Promoting
Interoperability performance categories will be less than 4.25 points
added to the final score, we believe a consistent approach is
preferable for simplicity, and we do not believe that a larger bonus is
appropriate as that could potentially inflate the quality performance
category score and the final score and mask poor performance.
---------------------------------------------------------------------------

\29\ We get 4.25 points using the following calculation: (3
measure bonus point/60 total measure points) * 85 percent * 100 =
4.25.
---------------------------------------------------------------------------

We requested comments on the proposal above. These comments and our
responses are discussed below.
Comment: Some commenters supported the proposal and recommended
that CMS continue to evaluate the least complicated method to apply the
small practice bonus in future years. One commenter indicated that a
small practice bonus should be retained as long as possible to support
small practices. A few commenters recommended stability over several
performance periods for the small practice bonus, with incentives
maintained over time with no changes from year-to-year. One commenter
recommended that CMS codify the small practice bonus for at least 3
years.
Response: We will evaluate MIPS data to determine whether any
future adjustment is still needed based on analysis of the performance
of small group practices compared to larger practices. While we
appreciate commenters' recommendations for stability in the bonus over
time, we believe that we must be guided by the annual analysis of small
practices' experience with the Quality Payment Program to determine if
the adjustment is still warranted. Any extension to the small practice
bonus would be proposed through future rulemaking.
Comment: One commenter recommended bonus points be applied evenly
across the following performance categories: Quality; improvement
activities; and Promoting Interoperability. Another commenter indicated
that it did not support a bonus based on the size or location of the
practice and recommended aligning the four performance categories and
awarding bonuses for activities that apply across the performance
categories. One commenter recommended that the clinician be allowed the
option to have bonus points added to a performance category of his or
her choice. A few commenters stated that small practices are
consistently disadvantaged compared to large health systems for not
only quality reporting, but also requirements of other performance
categories including Promoting Interoperability and improvement
activities.
Response: We considered dividing the small practice bonus between
the performance categories; however, we believe that spreading the
bonus across performance categories may not be appropriate, and the
other performance categories already take small practices into account.
As stated earlier, the improvement activities performance category
already includes special scoring for small practices. The Promoting
Interoperability performance category has a hardship exception for
small practices. The cost performance category does not require
submission of any data. For these reasons, we believe that it is
appropriate for the small practice bonus to be in the quality
performance category.
Comment: Many commenters did not support reducing the small
practice bonus from 5 points in the final score to 3 measure bonus
points in the quality performance category because of concerns that
small practices will receive less points, which may not support small
practices sufficiently. Several commenters stated that the bonus needs
to be significant enough so that adjustments provide more equitable
scoring to small practices. One commenter recommended that if the bonus
is applied in the quality performance category, 5 points should be
awarded.
Response: We understand commenters' concerns. We recently estimated
quality performance category scores for the 2019 MIPS performance
period using data from the 2017 MIPS performance period. This new data
was not available before the publication of the proposed rule. In this
new analysis, we found that the number of eligible clinicians whose
quality performance category was reweighted to 85 percent of the final
score was lower than we anticipated. We found that for approximately
three-fourths of the clinicians in small practices (and those not
subject to the APM scoring standard), quality was weighted between 45
and 60 percent when we applying our proposed CY 2019 performance period
policies to MIPS year 1 data. Thus, the 3 bonus points proposed (which
generally represents 5 percent of the quality performance category
score for small practices) would represent a lower overall bonus when
added to the final score than we had originally anticipated. While we
still believe that the small practice bonus should be applied to the
quality category performance score, it was not our intention to lower
the overall impact on the final score.
With our updated impact analysis in this final rule, we discovered
that trends identified when we originally established the small
practice bonus still exist. For example, in the CY 2018 Quality Payment
Program proposed rule (82 FR 30139 through 30140), we noted that
clinicians in practices with more than 100 clinicians may perform
better in the Quality Payment Program on average compared to clinicians
in smaller practices. We believed this trend was due primarily to two
factors: Participation rates and Web Interface reporting. While we
estimate more clinicians in small practices are participating in MIPS
in our updated model in this final rule compared to our estimates in
the 2019 PFS proposed rule, we still see a gap in quality participation
when comparing clinicians in small practices to clinicians in large
practices (89.8 percent compared to 100.0 percent respectively). We
also noticed a discrepancy in performance among those who submitted
data for the quality performance category. Prior to applying a small
practice bonus, the average quality score for submitters in small
practices was 62 percent compared to 82 percent for clinicians in large
groups. It is unclear whether the cause of the discrepancy is related
to Web Interface reporting, to performance, or to factors related to
data collection. While we continue to analyze the implications of these
results, we believe increasing the small practice bonus from 3 to 6
measure bonus points for 1 year would be appropriate to ensure that we
are correctly incentivizing participation

[[Page 59849]]

during the transition years without lowering the impact of the small
practice bonus. The other bonuses in the quality performance category
(for high-priority measures and end-to-end electronic reporting) are
capped at 10 percent of the denominator of the quality performance
category, which in almost all cases for small practices is 60 total
possible measure achievement points. Setting the bonus at 6 points
generally represents 10 percent of the quality performance category
score. For those clinicians who have six measures and for whom the
quality performance category weight is 45 percent, then the small
practice bonus would equate to 4.5 final score points. For those with a
quality performance category weight of 60 percent, the small practice
bonus would equate to 6 final score points. We recognize that for some
practices whose quality score is reweighted to 85 percent of their
final score, this may account for a large part of the final score;
however, based on the new CY 2017 MIPS performance period data, we do
not believe this will be the case for a large proportion of small
practices. On average, we estimate this change to the small practice
bonus will add 4.4 points to the final score for clinicians in small
practices who submit quality information to MIPS.
We want to remind readers that the small practice bonus was only
meant to be temporary and as we further analyze CY 2017 MIPS
performance period data we expect that the bonus will likely be reduced
or removed in future rulemaking. While we currently believe that it is
appropriate due to the unique challenges small practices experience
related to financial and other resources, as well as the performance
gap for small practices in comparison to larger practices, we believe
that upon further analysis of CY 2017 MIPS performance period data the
small practice bonus may not address the underlying reasons for the
disparate performance between small practices and other clinicians. As
a result, we intend to revisit this bonus during next year's rulemaking
cycle.
Comment: Many commenters stated that the small practice bonus
should not be embedded in the quality performance category and should
be a standalone bonus at the final score level to reduce complication
in scoring, provide greater flexibility, and reduce burden on small
practices. Several commenters stated that the quality performance
category is contributing less to the final score, since it is being
reduced from 50 percent to 45 percent, and may be reduced in the
future, which would continually reduce the small practice bonus. A few
commenters noted that moving the bonus to the quality performance
category provides additional scoring complexity and will not be
equitable, since the bonus will be applied to small practices
regardless of the number of measures submitted for the quality
performance category. For example, the bonus of 3 points for a
clinician being scored on one quality measure would translate to a
higher contribution to the final score than applying a bonus of 3
points for a clinician being scored on 6 measures. One commenter was
concerned that moving the small practices bonus to the quality
performance category will remove the opportunity for a bonus from
clinicians who do not, or cannot, report quality measures.
Response: We believe it is more appropriate for the small practice
bonus to reside in the quality performance category because small
practices have different reporting options than larger practices (for
example, only small practices are able to submit data via Medicare Part
B claims, but they cannot do so via the Web Interface), and burdens
associated with submitting data could affect the quality performance
category score. We also believe there is at least one quality measure
that is relevant to the vast majority of clinicians in the Quality
Payment Program. The small practice bonus is available to any small
practice submitting at least one quality measure. We reiterate that we
have special policies to assist small practices in the improvement
activities and Promoting Interoperability performance categories, which
limit the need for a small practice bonus in those performance
categories. The cost performance category does not require additional
burden to submit information and does not have the same reporting
restrictions as the quality performance category. Over time, we will
monitor the weight of the quality performance category and the small
practice contribution to the final score to determine if the amount of
the small practice bonus needs to be adjusted. We acknowledge that
moving the small practice bonus may add to the complexity of scoring,
but, on balance, we believe it is appropriate to encourage the
submission of quality measures. Also, we note that previously the small
practice bonus was added to the final score regardless of the number of
quality measures that were submitted. Although the bonus is now in the
quality category, the equity of the bonus does not change with this
policy. In addition, we will continue to monitor data to evaluate the
performance of small practices in the quality performance category to
determine differences between small and large practices and propose any
necessary changed in future rulemaking.
Comment: One commenter requested clarification on how CMS will
extend the small practice bonus to MIPS APMs.
Response: The small practice bonus will be applied to the final
quality performance category score for MIPS APMs at the MIPS APM
entity-level. For further discussion on our MIPS APM scoring policies,
we refer readers to section III.I.3.h.(6) of this final rule.
Comment: One commenter indicated that the bonus score changes based
on the reweighting of certain performance categories for clinicians,
which they believe gives an advantage to clinicians who have a higher
percentage of the score weighed to the quality performance category.
One commenter did not support moving the bonus to the quality
performance category, because the potential to reweight performance
categories results in a bonus that is not predictable during the
performance period for clinicians, who do not know which performance
categories will be reweighted.
Response: We appreciate that there might be differences in the
reweighting of performance categories for small practices. As stated
previously, we believe the quality performance category is an important
component of the Quality Payment Program. While it was our intention to
apply a bonus to the quality performance category with a cap
approximately equal to the final score small practice bonus for the
2018 MIPS performance period/2020 MIPS payment year, we recognize that
due to reweighting, the magnitude of the bonus will vary; however, in
order to reduce complexity, we believe that a uniform bonus of 6
measure bonus points added to the numerator for quality is appropriate.
As discussed in our response above, the policy is consistent with our
other quality performance category bonuses because, for most
clinicians, 6 measure bonus points is 10 percent of the 60-point
denominator within the quality performance category. In addition,
clinicians can predict whether their scores will be reweighted based on
eligibility and special status information in the lookup tool. We will
monitor the extent to which reweighting the quality performance
category contribution to the final score affects quality measure bonus
points awarded and so that we may keep the bonuses as equitable as
possible.
Comment: A few commenters indicated that the small practice bonus
should be extended to rural practices and different practice sizes. One

[[Page 59850]]

commenter recommended extending the bonus to all rural practices,
regardless of practice size, because of the belief that all rural
practices struggle with access to resources. One commenter indicated a
belief that the program offers few bonus points and opportunities for
high scores for small and rural practices, which may result in a skewed
scoring system that rewards large groups with resources to support
participation. One commenter recommended that the small practice bonus
be available to groups with 10 or less participants, to align the
definition with virtual group requirements. One commenter indicated
that groups with more than 15 clinicians should be considered a small
practice for purposes of the bonus.
Response: As discussed in the CY 2018 Quality Program final rule
(82 FR 53778), we observed that performance for rural MIPS eligible
clinicians is very similar to performance for non-rural MIPS clinicians
once we account for practice size, so we do not believe a bonus for
MIPS clinicians practicing in a rural setting is appropriate at this
time. Additionally, we discussed in the CY 2018 Quality Payment Program
final rule (82 FR 53777) that we believe it is important to maintain a
consistent definition of small practices within the Quality Payment
Program. In addition, we have not seen discrepancies between simulated
MIPS final scores for practices of 16 to 24 clinicians and for
practices of 15 or fewer clinicians. However, we will continue to
monitor this issue and assess whether there are scoring differences
between small rural and small urban practices and, if so, address it in
future rulemaking.
Comment: One commenter requested that CMS articulate how the
policies proposed align with other CMS efforts to support the long-
term, sustainable transformation of small practices and those serving
rural and underserved communities.
Response: We recognize the unique challenges that eligible
clinicians in small practices face and have established a unique set of
policies to reduce their participation burden and ease their transition
into the program. The special policies include the provisions related
to the assignment of 3 points for measures that do not meet data
completeness criteria which are finalized in section
III.I.3.i.(1)(b)(v) of this final rule; the significant hardship
exception for Promoting Interoperability performance category and the
associated reweighting policies available for small practices that do
not have CEHRT (2018 Quality Payment Program final rule (82 FR 53683));
special scoring provisions available for the improvement activities
performance category (82 FR 53656), and the provisions related to the
low-volume threshold at section III.I.3.c. of this final rule. We are
also continuing the Small, Underserved, and Rural Support initiative,
which provides no-cost technical assistance to MIPS eligible clinicians
in small practices. The initiative offers customized, one-on-one
support to help MIPS eligible clinicians in small practices familiarize
themselves with the program requirements, develop a strategy to
successfully participate, and continue improving outcomes for
beneficiaries. See: https://qpp.cms.gov/about/small-underserved-rural-
practices for further information.
As discussed in the response above, we have estimated quality
performance category scores using data from the 2017 MIPS performance
period. As a result of this new data that was not available before the
publication of the proposed rule we believe increasing the small
practice bonus from 3 to 6 measure bonus points would be appropriate to
ensure that we are correctly incentivizing participation without
lowering the final score of small practices. The other bonuses in the
quality performance category (for high-priority measures and end-to-end
electronic reporting) are capped at 10 percent of the denominator of
the quality performance category, which in almost all cases for small
practices is 60 total possible measure achievement points. Setting the
bonus at 6 points generally represents 10 percent of the quality
performance category score.
After consideration of public comments, we are not finalizing as
proposed the proposal to amend Sec. 414.1380(b)(1)(v)(C) to add,
beginning with the 2021 MIPS payment year, a small practice bonus of 3
measure bonus points in the numerator of the quality performance
category for MIPS eligible clinicians in small practices if the MIPS
eligible clinician submits data to MIPS on at least 1 quality measure.
Instead, based on the rationale discussed previously, we are finalizing
the amendment of Sec. 414.1380(b)(1)(v)(C) to add, beginning with the
2021 MIPS payment year, a small practice bonus of 6 measure bonus
points in the numerator of the quality performance category for MIPS
eligible clinicians in small practices if the MIPS eligible clinician
submits data to MIPS on at least 1 quality measure.
(ix) Incentives To Report High-Priority Measures
In the CY 2017 Quality Payment Program final rule, we established a
cap on high-priority measure bonus points for the first 2 years of MIPS
at 10 percent of the denominator (total possible measure achievement
points the MIPS eligible clinician could receive in the quality
performance category) of the quality performance category (81 FR
77294). As part of our proposed technical updates to Sec.
414.1380(b)(1) discussed in section III.I.3.i.(1)(b) of this final
rule, our previously established policy on incentives to report high-
priority measures is now referenced at Sec. 414.1380(b)(1)(v)(A). In
the CY 2019 PFS proposed rule, we proposed to maintain the cap on
measure bonus points for reporting high-priority measures for the 2021
MIPS payment year, and to amend Sec. 414.1380(b)(1)(v)(A)(1)(ii),
accordingly (83 FR 35951).
We requested comments on the proposal above. These comments and our
responses are discussed below.
Comment: One commenter supported the proposal to maintain the cap
on measure bonus points for reporting high-priority measures for the
2019 performance period/2021 MIPS payment year.
Response: We thank the commenter for its support of our proposal.
After consideration of public comments, we are finalizing our
proposal to maintain the cap on measure bonus points for reporting
high-priority measures for the 2021 MIPS payment year, and to amend
Sec. 414.1380(b)(1)(v)(A)(1)(ii), accordingly.
We established the scoring policies for high-priority measure bonus
points in the CY 2017 Quality Payment Program final rule (81 FR 77293).
We noted that, in addition to the required measures, CMS Web Interface
reporters may also report the CAHPS for MIPS survey and receive measure
bonus points for submitting that measure (81 FR 77293). We refer
readers to Sec. 414.1380(b)(1)(v)(A) for more details on the high-
priority measure bonus points scoring policies.
For the 2021 MIPS payment year, we proposed to modify the policies
finalized in the CY 2017 Quality Payment Program final rule (and amend
Sec. 414.1380(b)(1)(v)(A) accordingly) to discontinue awarding measure
bonus points to CMS Web Interface reporters for reporting high-priority
measures (83 FR 35951). As we continue to move forward in implementing
the MIPS program, we no longer believe that it is appropriate to award
CMS Web Interface reporters measure bonus points to be consistent with
other policies regarding selection of measures. Based on additional
data analyses since the first-year policy was implemented,

[[Page 59851]]

we have found that practices that elect to report via CMS Web Interface
generally perform better than other practices that select other
collection types. Therefore, the benefit of the bonus points is limited
and instead we believe will create higher than normal scores. Bonus
points were created as transition policies which were not meant to
continue through the life of the program. Measure bonus points are also
used to encourage the selection of additional high-priority measures.
As the program matures, we have established other policies related to
measures selection, such as applying a cap of 7 measure achievement
points if a clinician selects and submits a measure that has been
topped out for 2 or more years; however, we have excluded CMS Web
Interface reporters from the topped out policies because reporters have
no choice in measures. By the same logic, since CMS Web Interface
reporters have no choice in measures, we do not believe it is
appropriate to continue to provide additional high-priority measure
bonuses for reporting CMS Web Interface measures. We note the CMS Web
Interface users may still elect to report the CAHPS for MIPS survey in
addition to the CMS Web Interface, and if they do, they would receive
the high priority bonus points for reporting the survey.
We requested comments on the proposal above. These comments and our
responses are discussed below.
Comment: A few commenters supported the proposal to discontinue
awarding high-priority measure bonus points to CMS Web Interface
reporters because it strengthens the incentive to report high-priority
measures for those who actively elect to report these measures and
reduces the advantage for the large practices that are able to report
through CMS Web Interface. One commenter expressed support for the
proposal because groups who report via Web Interface perform better
than groups who use alternative data collection types, have an
increased probability of earning higher quality performance category
and overall higher MIPS scores, and can still earn bonus points for
reporting CAHPS for MIPS survey measures.
Response: We thank the commenters for their support as we look for
ways to improve our scoring policy.
Comment: Several commenters did not support the proposal to remove
high-priority bonus points for CMS Web Interface reporters. One
commenter stated it would disincentivize clinicians and groups from
participating in APMs and stated that ACOs do not have an alternative
submission method. Another commenter suggested that the bonus points
should continue for non-MIPS APM participants because these submitters
voluntarily choose a larger and more difficult and complex set of
measures than are required. A few commenters stated that there is not
an option to submit additional high-priority measures to earn these
bonus points and that this proposal disadvantages ACOs which have
demonstrated a high commitment to quality as evidenced by recent MIPS
performance feedback reports. One commenter recommended that CMS should
not remove all bonus points until it proposes to do the same for the
other collection types. A few commenters suggested delaying removal of
the bonus points to allow clinicians sufficient notice and until
further information and insight is gained about performance in these
measures. One commenter stated that the policy penalizes Web Interface
reporters for their commitment to measures that truly reflects their
practices.
Response: The high priority measure bonus points were intended to
encourage the selection of certain measures. As we work towards
improving our scoring policy to align with our goals of improving
quality of care, we no longer believe we should award bonus points to
CMS Web Interface reporters because they do not select individual
measures to report, rather the Web Interface is a measurement set. This
bonus policy was meant to be temporary, and we believe that as the MIPS
program goes into its third year it is an appropriate time to begin to
limit the assignment of high priority bonus points. While we recognize
the commenters' concerns, the removal of the bonus was not intended to
penalize Web Interface reporters and we still have several special
policies available for Web Interface reporters. We have excluded CMS
Web Interface reporters from the topped out measure cap (82 FR 53576),
so although they are no longer able to receive this bonus, they are
still able to receive maximum achievement points for all measures, even
though some of the CMS Web Interface measures may be considered topped
out. Additionally, CMS Web Interface reporters are still able to
receive measure bonus points for reporting the CAHPS for MIPS survey
and for end-to-end reporting.
We will consider commenters' concerns in future rulemaking.
After consideration of public comments, we are finalizing our
proposal, beginning with the 2021 MIPS payment year, to discontinue
awarding measure bonus points to CMS Web Interface reporters for
reporting high-priority measures and to amend Sec.
414.1380(b)(1)(v)(A) accordingly.
As part of our move towards fully implementing the high value
measures as discussed in section III.I.3.h.(2)(b)(iv) of this final
rule, we believe that bonus points for high priority measures for all
collection types may no longer be needed, and as a result, we intend to
consider in future rulemaking whether to modify our scoring policy to
no longer offer high priority bonus points after the 2021 MIPS payment
year (83 FR 35951).
We thank commenters for suggestions and may consider them for
future rulemaking.
(x) Incentives To Use CEHRT To Support Quality Performance Category
Submissions
Section 1848(q)(5)(B)(ii) of the Act requires the Secretary to
encourage MIPS eligible clinicians to report on applicable quality
measures through the use of CEHRT. Under Sec. 414.1380(b)(1)(xv), 1
bonus point is available for each quality measure submitted with end-
to-end electronic reporting, under certain criteria. In order to
receive the bonus for end-to-end reporting, eligible clinicians must
use the 2015 Edition CEHRT. We refer readers to the CY 2017 Quality
Payment Program final rule (81 FR 77297) and section
III.I.3.h.(2)(b)(i) of this final rule for further discussion on our
certification requirements for the end-to-end reporting bonus. As part
of our proposed technical updates to Sec. 414.1380(b)(1) discussed in
section III.I.3.i.(1)(b) of this final rule, our previously established
electronic end-to-end reporting bonus point scoring policy is now
referenced at Sec. 414.1380(b)(1)(v)(B).
In the CY 2019 PFS proposed rule, we proposed to maintain the cap
on measure bonus points for end-to-end electronic reporting for the
2021 MIPS payment year (83 FR 35951). We also proposed to continue to
assign bonus points for end-to-end electronic reporting for the 2021
MIPS payment year, as we have seen that this policy encourages
electronic reporting. We proposed to amend Sec. 414.1380(b)(1)(v)(B)
accordingly.
We requested comments on the proposal above. These comments and our
responses are discussed below.
Comment: Several commenters supported maintaining the bonus points
for end-to-end electronic reporting for the 2021 MIPS payment year and
requested that CMS continue to assign them in future years. One
commenter

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noted that continuing the bonus points beyond the 2021 MIPS payment
year will allow clinicians in smaller practices who are not yet capable
of end-to-end electronic reporting an opportunity to do so. Another
commenter supported the bonus only if those that are not able to submit
using end-to-end electronic reporting have access to CEHRT at no cost
to the clinician. One commenter suggested that CMS continue the bonus
points until the program is more mature and additional data on
performance and reporting is gathered. A few commenters who supported
maintaining the bonus points beyond the 2021 MIPS payment year, stated
that the removal of the bonus points would result in increased
administrative burden to CMS and clinicians, and would adversely affect
the ability for clinicians with limited quality measures available to
earn bonus points.
Response: While we signaled our intent to discontinue bonus points
for end-to-end electronic reporting in the future (83 FR 35951), we are
taking into consideration the suggestions we received on additional
ways we can incentivize and encourage these reporting methods for
future rulemaking.
After consideration of public comments, we are finalizing our
proposals to continue to assign and maintain the cap on measure bonus
points for end-to-end electronic reporting for the 2021 MIPS payment
year and to amend Sec. 414.1380(b)(1)(v)(B) accordingly.
We also proposed to modify our end-to-end reporting bonus point
scoring policy based on the changes to the submission terminology
discussed in section III.I.3.h.(1)(b) of this final rule (83 FR 35951).
We proposed that the end-to-end reporting bonus can only apply to the
subset of data submitted by direct, log in and upload, and CMS Web
Interface that meet the criteria finalized in the CY 2017 Quality
Payment Program final rule (81 FR 77297 through 77298). However, the
end-to-end reporting bonus would not be applied to the claims
submission type because it does not meet the criteria discussed above.
This is not a policy change but rather a clarification of our current
process in light of the proposed terminology changes.
We did not receive any comments on this proposal.
After consideration of public comments, we are finalizing our
proposals to modify our end-to-end reporting bonus point scoring policy
based on the changes to the submission terminology and only apply the
bonus to the subset of data submitted by direct, log in and upload, and
CMS Web Interface that meet the criteria finalized in the CY 2017
Quality Payment Program final rule (81 FR 77297 through 77298).
As discussed in section III.I.3.i.(1)(b)(x) of this final rule, we
believe that in the future, bonus points for end-to-end reporting for
all submission types will no longer be needed as we move towards fully
implementing the program, and as a result we intend to consider in
future rulemaking modifying our scoring policy to no longer offer end-
to-end reporting bonus points after the 2021 MIPS payment year (83 FR
35951). Consistent with the section 1848(q)(5)(B)(ii) of the Act, which
requires the Secretary to encourage the use of CEHRT for quality
reporting, we will continue to be committed to ways that we can
incentivize and encourage these reporting methods. We invited comment
on other ways that we can encourage the use of CEHRT for quality
reporting.
We thank commenters for suggestions and will consider them for
future rulemaking.
(xi) Calculating Total Measure Achievement and Measure Bonus Points
(A) Calculating Total Measure Achievement and Measure Bonus Points for
Non-CMS Web Interface Reporters
In the CY 2017 and 2018 Quality Payment Program final rules (81 FR
77300, and 82 FR 53733 through 53736, respectively), we established the
policy for calculating total measure achievement and measure bonus
points for Non-CMS Web Interface reporters. We refer readers to Sec.
414.1380(b)(1) for more details on these policies.
We did not propose any changes to the policy for scoring submitted
measures collected across multiple collection types; however, we
provided a summary of how this policy will be scored using our new
terminology (83 FR 35952). We noted that CMS Web Interface and
facility-based measurement each have a comprehensive set of measures
that meet the proposed MIPS category requirements. As a result, we did
not combine CMS Web Interface measures or facility-based measurement
with other ways groups can be scored for data submitted for MIPS (other
than CAHPS for MIPS, which can be submitted in conjunction with the CMS
Web Interface). We refer readers to section III.I.3.i.(1)(d) of this
final rule for a description of our policies on facility-based
measurement (83 FR 35956 through 35963).
Although we have established a policy to account for scoring in
circumstances when the same measure is collected via multiple
collection types, we anticipate that this will be a rare circumstance
and do not encourage clinicians to submit the same measure collected
via multiple collection types. Table 51 is included in this final rule
for illustrative purposes and clarity due to the changes in terminology
discussed in section III.I.3.h.(1)(b) of this final rule (83 FR 35893
through 35895). For further discussion of this example, we refer
readers to the CY 2018 Quality Payment Program final rule (82 FR
53734).
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We did not propose any changes to our policy regarding scoring
measure achievement points and bonus points when using multiple
collection types for non-Web Interface MIPS eligible clinicians in the
quality performance category for the 2019 MIPS performance period.
(B) Calculating Total Measure Achievement and Measure Bonus Points for
CMS Web Interface Reporters
In the CY 2017 and 2018 Quality Payment Program final rules (81 FR
77302 through 77306, and 82 FR 53736 through 82 FR 53737,
respectively), we finalized the scoring policies for CMS Web Interface
reporters. As part of our technical updates to Sec. 414.1380(b)(1)
discussed in section III.I.3.i.(1)(b) of this final rule, our
previously established policies for CMS Web Interface reporters are now
referenced at Sec. 414.1380(b)(1)(i)(A)(2)(i) and (b)(1)(v)(A).
(xii) Future Approaches To Scoring the Quality Performance Category
As we discuss in section III.I.3.h.(2)(b)(iv) of this final rule,
we anticipate making changes to the quality performance category to
reduce burden and increase the value of the measures we are collecting.
We discussed that existing measures have differing levels of value and
our approaches for implementing a system where points are awarded based
on the value of the measure. Should we adopt these approaches, we
anticipate needing to modify our scoring approaches accordingly. In
addition, we have received stakeholder feedback requesting that we
simplify scoring for the quality performance category. Therefore, we
solicited comment on the following approaches to scoring that we may
consider in future rulemaking and whether these approaches move the
clinicians towards reporting high value measures and more accurate
performance measurement (83 FR 35954 through 35955).
One option for simplification is restructuring the quality
requirements with a pre-determined denominator, for example, 50 points,
but no specific requirements regarding the number of measures that must
be submitted. Further, we would categorize MIPS and QCDR measures by
value, because we recognize that not all measures are created equal. We
seek to ensure that the collection and submission of data is valuable
to clinicians and worth the cost and burden of collection of
information. A system to classify measures as a particular value (for
example, gold, silver, or bronze) is discussed in section
III.I.3.h.(2)(b)(iv) of this final rule. In this approach, the highest
tier would include measures that are considered ``gold'' standard, such
as outcome measures, composite measure, or measures that address agency
priorities (such as opioids). The CAHPS for MIPS survey, which collects
patient experience data, may also be considered a high-value measure.
Measures considered in the second tier, or at a ``silver'' standard,
would be process measures that are directly related to outcomes and
have a good gap in performance (there is no high, unwavering
performance) and demonstrate room for improvement, or topped out
outcome measures. Lower value measures, such as standard of care
process measures or topped out process measures, would have scoring
caps in place that would reflect the measure's status as a ``bronze
measure.'' In this scenario, we could envision awarding points for
achievement as follows: Up to 15 to 20 points in the top tier; up to 10
points in the next tier; and up to 5 points in the lowest tier. Similar
to the structure of the improvement activities performance category, a
clinician that chooses a top-tier measure would not have to submit as
many measures to MIPS. We would still want to ensure the submission of
high value measures and might include requirements that restrict the
number of lower tier measures that could be submitted; alternatively,
we could add a requirement that a certain number of higher tier
measures would need to be submitted. With this approach, we could still
incentivize reporting on high-priority measures by classifying them as
``gold'' standard measures which would be eligible for up to 15 to 20
achievement points.
Alternatively, we could keep our current approach for the quality
performance category requiring 6 measures including one outcome
measure, with every measure worth up to 10 measure achievement points
in the denominator but change the minimum number of measure achievement
points available to vary by the measure tier. For example, high-tier
measures could qualify for high priority bonus and/or have a higher
potential floor (for example, 5 measure achievement points instead of
the floor of 3 measure achievement points for ``gold'' standard
measures, which would be eligible for up to 10 measure achievement
points.); whereas low-tier measures could have a lower floor (for
example, 1 measure achievement point instead of the floor of 3 measure
achievement points for ``bronze standard' measures).
Taking into consideration the potential future quality performance
category change, we also believe that removing the validation process
to determine whether the eligible clinician has measures that are
available and applicable would simplify the quality performance
category significantly. Several stakeholders have expressed their
confusion with the validation process. A move to sets of measures in
the quality performance category, potentially with some criteria to
define the clinicians for whom these measures are applicable, would
eliminate the need for a validation process for measures that are
available and

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applicable. Moving to sets of measures would also enable us to develop
more robust benchmarks. We also believe that in the next few years, we
could remove the validation process for measures that are available and
applicable if we set the denominator at a pre-determined level (as
outlined in the example above at 50 points) and let clinicians
determine the best method to achieve 50 points. For the 2019 and 2020
MIPS payment years, MIPS eligible clinicians and groups who report on
QCDR measures that do not have an available benchmark based on the
baseline or performance period but meet data completeness are assigned
a score of 3 measure achievement points (small practices receive 3
points regardless of whether they meet data completeness). Through
stakeholder engagement, particularly feedback provided by QCDRs who
have developed their own measures, we have heard that MIPS eligible
clinicians are hesitant to report QCDR measures without established
benchmarks. Eligible clinicians have voiced concern on reporting on
QCDR measures without benchmarks because they are not certain that a
benchmark could be calculated and established for the MIPS performance
period, and they would therefore be limited to a 3-point score for that
QCDR measure. In addition, QCDRs have inquired about the possibility of
creating QCDR benchmarks. To encourage reporting of QCDR measures, we
sought comment on an approach to develop QCDR measure benchmarks based
off historical measure data. This may require QDCRs to submit
historical data in a form and manner that meets benchmarking needs as
required by CMS. We anticipate that the historical QCDR measure data
would need to be submitted at the time of self-nomination of the QCDR
measure, during the self-nomination period. Detailed discussion of the
self-nomination period timeline and requirements can be found in
section III.I.3.k of this final rule. Our concern with utilizing
historical data provided by QCDRs to develop benchmarks is whether
QCDRs have the capability to filter through their historical measure
data to extract only data from MIPS eligible clinicians and groups
prior to submitting the historical data to CMS for QCDR measure
benchmarking consideration. Furthermore, once the historical data is
submitted by the QCDR, CMS would analyze the data to ensure that it met
benchmarking standards prior to it being accepted to form a benchmark.
However, to perform this analysis CMS may need additional data elements
such as the sources of the data, data completeness, and the collection
period. In addition to seeking comment on developing QCDR measure
benchmarks from historical data, we also solicited comment as to how
our aforementioned concerns may be addressed in future rulemaking.
We also recognize that improving the electronic capture,
calculation, and reporting of quality measures is also an important
component of reducing provider burden. We invited comment on how we can
incorporate incentives for the use of electronic clinical quality
measurement into the future approaches described under this section, as
well as other ways to encourage more efficient technology-enabled
measurement approaches.
We solicited comment on these approaches and other approaches to
simplify scoring, provide incentives to submit more impactful measures
that assess outcomes rather than processes, and develop data that can
show differences in performance and determine clinicians that provide
high value care (83 FR 35954 through 35955).
We thank commenters for suggestions and will consider them for
future rulemaking.
(xiii) Improvement Scoring for the MIPS Quality Performance Category
Percent Score
Section 1848(q)(5)(D)(i) of the Act stipulates that, beginning with
the second year to which the MIPS applies, if data sufficient to
measure improvement is available, the improvement of the quality
performance category score for eligible clinicians should be measured.
To measure improvement, we require a direct comparison of data from one
Quality Payment Program year to another (82 FR 52740). For more
descriptions of our current policies, we refer readers to the CY 2018
Quality Payment Program final rule (82 FR 53737 to 53747). As part of
our technical updates to Sec. 414.1380(b)(1) discussed in section
III.I.3.i.(1)(b) of this final rule, our previously established
improvement scoring policies are now referenced at Sec.
414.1380(b)(1)(vi).
In the CY 2018 Quality Payment Program final rule, we adopted a
policy that MIPS eligible clinicians must fully participate to receive
a quality performance category improvement percent score greater than
zero (82 FR 53743 through 53745). In Sec. 414.1380(b)(1)(vi)(F), we
determined ``participation'' to mean compliance with Sec. 414.1330 and
Sec. 414.1340 in the current performance period. We issued a technical
correction for the CY 2018 Quality Payment Year final rule, replacing
Sec. 414.1330 with Sec. 414.1335 since Sec. 414.1335 is more
specific because it discusses the quality performance category
requirements.
We finalized at Sec. 414.1380(b)(1)(vi)(C)(4) that we would
compare the 2018 performance to an assumed 2017 quality performance
category achievement percent score of 30 percent if a MIPS eligible
clinician earned a quality performance category score less than or
equal to 30 percent in the previous year (82 FR 53744 through 53745).
In the CY 2019 PFS proposed rule, we proposed to continue this policy
for the 2019 MIPS performance period and amend Sec.
414.1380(b)(1)(vi)(C)(4), accordingly (83 FR 35955). We proposed to
compare the 2019 performance to an assumed 2018 quality performance
category achievement percent score of 30 percent.
The following is a summary of the public comments on the proposal
and our responses:
Comment: One commenter supported the proposal.
Response: We thank the commenter for its support.
After consideration of public comments, we are finalizing the
proposal to continue our previously established policy for the 2019
MIPS performance period and amend Sec. 414.1380(b)(1)(vi)(C)(4),
accordingly. Specifically, we will compare the 2019 performance to an
assumed 2018 quality performance category achievement percent score of
30 percent if a MIPS eligible clinician earned a quality performance
category score less than or equal to 30 percent in the previous year.
(xiv) Calculating the Quality Performance Category Percent Score
Including Achievement and Improvement Points
In the CY 2017 and CY 2018 Quality Payment Program final rules (81
FR 77300 and 82 FR 53747 through 53748, respectively), we finalized the
policies on incorporating the improvement percent score into the
quality performance category percent score. As part of our technical
updates to Sec. 414.1380(b)(1) discussed in section III.I.3.i.(1)(b)
of this final rule, our previously established policies are now
referenced at Sec. 414.1380(b)(1)(vii).
(c) Scoring the Cost Performance Category
(i) Scoring Achievement in the Cost Performance Category
For a description of the statutory basis and our existing policies
for scoring achievement in the cost performance

[[Page 59856]]

category, we refer readers to the CY 2017 Quality Payment Program final
rule (81 FR 77308 through 77311) and the CY 2018 Quality Payment
Program final rule (82 FR 53748 through 53749). In the CY 2017 Quality
Payment Program final rule (81 FR 77308 through 77309), we established
that we will determine cost measure benchmarks based on cost measure
performance during the performance period. We also established that at
least 20 MIPS eligible clinicians or groups must meet the minimum case
volume that we specify for a cost measure in order for a benchmark to
be determined for the measure, and that if a benchmark is not
determined for a cost measure, the measure will not be scored. We
proposed to codify these final policies at Sec. 414.1380(b)(2)(i) (83
FR 35955 through 35956).
While we did not receive any public comments for this proposal, we
are finalizing our proposal to codify these final policies at Sec.
414.1380(b)(2)(i).
(ii) Scoring Improvement in the Cost Performance Category
For a description of the statutory basis and our existing policies
for scoring improvement in the cost performance category, we refer
readers to the CY 2018 Quality Payment Program final rule (82 FR 53749
through 53752). Section 51003(a)(1)(B) of the Bipartisan Budget Act of
2018 modified section 1848(q)(5)(D) of the Act such that the cost
performance category score shall not take into account the improvement
of the MIPS eligible clinician for each of the second, third, fourth,
and fifth years for which the MIPS applies to payments. We do not
believe this change requires us to remove our existing methodology for
scoring improvement in the cost performance category (see 82 FR 53749
through 53752), but it does prohibit us from including an improvement
component in the cost performance category percent score for each of
the 2020 through 2023 MIPS payment years. Therefore, we proposed to
revise Sec. 414.1380(b)(2)(iv)(E) to provide that the maximum cost
improvement score for the 2020, 2021, 2022, and 2023 MIPS payment years
is zero percentage points (83 FR 35955). Under our existing policy (82
FR 53751 through 53752), the maximum cost improvement score for the
2020 MIPS payment year is 1 percentage point, but due to the statutory
changes and under our proposal, the maximum cost improvement score for
the 2020 MIPS payment year would be zero percentage points. We also
proposed at Sec. 414.1380(a)(1)(ii) to modify the performance
standards to reflect that the cost performance category percent score
will not take into account improvement until the 2024 MIPS payment year
(83 FR 35956). The following is a summary of the public comments
received on these proposals and our responses:
Comment: A few commenters supported the proposals to set the
maximum cost improvement score for the 2020, 2021, 2022, and 2023 MIPS
payment years at zero percentage points.
Response: We thank the commenter for their support.
Comment: Several commenters requested that the cost performance
category score be determined in a different manner because of the
proposed inclusion of episode-based measures. A few commenters
recommended that the new measures have a lower weight in determining
the cost performance category score than the previously-established
MSPB and total per capita cost measures. A few commenters recommend
that similar to the quality performance category, only the 6 measures
with the highest scores among those for which the clinician or group
met the case minimum should be included in calculating the cost
performance category score. Likewise, a few commenters recommended that
similar to the quality performance category, scores for cost measures
should not be below 3 out of 10 points. One commenter recommended that
a cost performance category score not be calculated if a clinician or
group only meets the case minimum for a single cost measure.
Response: We do not believe that the inclusion of new measures in
the cost performance category necessitates a change in the
determination of the cost performance category score. Measures in the
cost performance category differ from quality measures because they do
not require reporting on the part of the clinicians outside of the
usual claims submission process. Therefore, there is no choice of
measures for clinicians nor burden of reporting. We believe that this
is an important consideration in maintaining a simpler scoring
mechanism in the cost performance category and scoring all measures for
which an individual or group meets the case minimum. Some groups due to
their size and comprehensiveness will meet the case minimum for all
cost measures. Other individuals and groups will meet the case minimum
for fewer measures. A scoring policy that would only score the top 6
measures in the cost performance category would provide an advantage
for those groups with more than 6 measures because it would disregard
those measures on which performance was poorest. For example, a group
that met the case minimum for 10 measures and scored in the lowest
decile for the total per capita cost score and the highest decile for
all other measures, would have the score for the total per capita
measure dropped and would receive the highest possible score in the
cost performance category. A group that met the case minimum for only 6
measures, and also performed in the lowest decile for the total per
capita cost score and the highest decile for the other 5 cost measures
for which it met the case minimum, would not have performance on this
measure disregarded and receive a lower score.
We believe that not scoring clinicians and groups that meet the
case minimum for only a single measure would fail to recognize that a
single measure, such as total per capita cost, could reflect care
provided to a large number of patients.
After consideration of the public comments, we are finalizing as
proposed our proposal to revise Sec. 414.1380(b)(2)(iv)(E) to provide
that the maximum cost improvement score for the 2020, 2021, 2022, and
2023 MIPS payment years is zero percentage points. We are also
finalizing as proposed our proposal at Sec. 414.1380(a)(1)(ii) to
modify the performance standards to reflect that the cost performance
category percent score will not take into account improvement until the
2024 MIPS payment year.
(d) Facility-Based Measures Scoring Option for the 2021 MIPS Payment
Year for the Quality and Cost Performance Categories
(i) Background
In the CY 2018 Quality Payment Program final rule, we established a
facility-based measurement scoring option for clinicians that meet
certain criteria beginning with the 2019 MIPS performance period/2021
MIPS payment year (82 FR 53752 through 53767). We originally proposed a
facility-based measurement scoring option for the 2018 MIPS performance
period. We did not finalize the policy because we were concerned that
we would not have the operational ability to inform clinicians early
enough in the 2018 MIPS performance period to allow them to consider
the consequences and benefits of participation (82 FR 53755).
(ii) Facility-Based Measurement Applicability
(A) General
In the CY 2018 Quality Payment Program final rule, we limited
facility-based reporting to the inpatient hospital in the first year
for several reasons,

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including because a more diverse group of clinicians (and specialty
types) provide services in an inpatient setting than in other settings,
and because the Hospital Value-Based Purchasing (VBP) Program adjusts
payment to hospitals for inpatient services in connection with their
performance under that program (82 FR 53753 through 53755). We also
limited measures applicable for facility-based measurement to those
used in the Hospital VBP Program because the Hospital VBP Program
compares hospital performance on a series of different measures
intended to capture the breadth of inpatient care in the facility (82
FR 53753). We noted that we were open to the consideration of
additional facility types in the future but recognized that adding a
facility type would be dependent upon whether CMS has established a
value-based purchasing program for that facility type, the
applicability of measures, and our ability to appropriately attribute a
clinician to a facility (82 FR 53754). Please note that when we use the
term value-based purchasing, we are referring in general to value-based
purchasing programs or scores, and not specifically the Hospital VBP
Program, unless specifically stated.
We did not propose to add additional facility types for facility-
based measurement, but we are interested in potentially expanding to
other settings in future rulemaking. Therefore, in section
III.I.3.i.(1)(d)(vii) of this final rule, we outline several issues on
which we requested feedback and would need to be resolved in order to
expand this option to a wider group of facility-based clinicians in
future years.
(B) Facility-Based Measurement by Individual Clinicians
In the CY 2018 Quality Payment Program final rule, we established
individual eligibility criteria for facility-based measurement at Sec.
414.1380(e)(2)(i). We established that a MIPS eligible clinician who
furnishes 75 percent or more of his or her covered professional
services in sites of service identified by the POS codes used in the
HIPAA standard transaction as an inpatient hospital or emergency room
based on claims for a period prior to the performance period as
specified by CMS (82 FR 53756 through 53757) is eligible as an
individual for facility-based measurement. We had noted, as a part of
our proposal summary, that we would use the definition of professional
services in section 1848(k)(3)(A) of the Act in applying this standard
(82 FR 53756). For purposes of determining eligibility for facility-
based measurement, we discussed CMS using data from the period between
September 1 of the calendar year, 2 years preceding the MIPS
performance period, through August 31 of the calendar year preceding
the MIPS performance period, with a 30-day claims run out but did not
finalize that as part of the applicable regulation (82 FR 53756 through
53757). Because we are using the quality measures associated with the
inpatient hospital to determine the MIPS quality and cost performance
category score, we wanted to ensure that eligible clinicians
contributed to care in that setting during that time period.
We indicated that CMS will use POS code 21 (inpatient) and POS code
23 (emergency department) for this purpose (82 FR 53756). Commenters on
our proposal (as summarized in the CY 2018 Quality Payment Program
final rule (82 FR 53756 through 53757)) expressed concern that adopting
the definition that we did for facility-based clinicians would limit
the number of clinicians who would be eligible.
In the CY 2019 PFS proposed rule, we proposed to modify our
determination of a facility-based individual at Sec. 414.1380(e)(2)(i)
in four ways (83 FR 35957). First, we proposed to add on-campus
outpatient hospital (as identified in the POS code in the HIPAA
standard transaction, that is, POS code 22) to the settings that
determine whether a clinician is facility-based. Second, we proposed
that a clinician must have at least a single service billed with the
POS code used for the inpatient hospital or emergency room. Third, we
proposed that, if we are unable to identify a facility with a value-
based purchasing score to attribute as a clinician's performance, that
clinician is not eligible for facility-based measurement. Fourth, we
proposed to align the time period for determining eligibility for
facility-based measurement with changes to the dates used to determine
MIPS eligibility and special status detailed in section III.I.3.b. of
this final rule. We explain these four proposals from the proposed rule
in this section. In the CY 2019 PFS proposed rule, we stated our belief
that these proposals will further expand the opportunity for facility-
based measurement and eliminate issues associated with the provision of
observation services while still restricting eligibility to those who
work in an inpatient setting.
First, we proposed to add the on-campus outpatient hospital (POS
code 22) to the list of sites of service used to determine eligibility
for facility-based measurement (83 FR 35957). We agree with commenters
that limiting the eligibility to our current definition may prevent
some clinicians who are largely hospital-based from being eligible.
However, expanding eligibility without taking into account the
relationship between the clinician and the facility and facility's
performance could result in unfairly attributing to a clinician
performance for which the clinician is not responsible or has little to
no role in improving. We do believe that a significant provision of
services in the on-campus outpatient hospital are reflected in the
quality captured by the Hospital VBP Program. For example, patients in
observation status are typically treated by the same staff and
clinicians as those who meet the requirements for inpatient status.
Although there are some clinical differences that may result in a
patient having observation status, we believe that the quality of care
provided to these patients in this same setting would be comparable,
reflecting the overall healthcare system at that particular location.
In the CY 2019 PFS proposed rule, we stated our conviction, based on
this that a sufficient nexus exists for attributing the hospital's VBP
Total Performance Score to clinicians that provide services in on-
campus outpatient hospital settings.
Second, we proposed to require that clinicians bill at least a
single service with the POS codes for inpatient hospital or the
emergency room in order to be eligible for facility-based measurement
(83 FR 35957). Although we generally believe that clinicians who
provide services in the outpatient hospital can affect the quality of
care for inpatients, we noted in the CY 2019 PFS proposed rule our
belief that a clinician who is measured according to the performance of
a hospital should at least have a minimal presence in the inpatient or
emergency room setting. We explained our concern about attributing
inpatient facility performance to clinicians who provide at least 75
percent of their services at on-campus outpatient hospitals (with POS
code 22) when such clinicians exclusively provide outpatient services
that are unrelated to inpatient hospital service by describing an
example: A dermatologist who provides office-based services in a
hospital-owned clinic but who never admits or treats patients within
the inpatient or emergency room setting does not meaningfully
contribute to the quality of care for patients measured under the
Hospital VBP Program.
We stated in the CY 2019 PFS proposed rule how we had considered
different ways to best identify those who contribute to the quality of
care in the inpatient setting while keeping the

[[Page 59858]]

facility-based scoring option as simple as possible. We provided one
explanation of an alternative we had considered: Separately measuring
the HCPCS codes for observation services; however, as also noted in the
proposed rule, we believe that such a measurement may not fairly
consider services provided by clinicians for whom observations services
may be embedded in a global code for a procedure rather than billed as
a separate observation service. We also considered requiring a
clinician to provide a certain percentage of services with the
inpatient hospital POS. We described how we had not identified a
threshold (other the one claim threshold we proposed) that would more
meaningfully differentiate clinicians who provide services with the
outpatient hospital POS code versus those who do not contribute to the
services that would be measured under the Hospital VBP Program. We
identified our goal of ensuring that the program rules are clear and
easily applied to clinicians, so as to both avoid confusion on program
participation requirements and to meet overall agency goals to increase
transparency in the agency's activities. Our proposal of using a single
service as the threshold would provide a simple, bright-line to
differentiate those who never provide inpatient services from
clinicians that do provide inpatient services as well as outpatient
services. We explained in the proposed rule that this would limit the
chance of clinicians who exclusively practice in the outpatient setting
being measured on the Hospital VBP Program's performance of an
unrelated hospital. We recognized this requirement of one service with
the inpatient or emergency department POS may not demonstrate a
significant presence in a particular facility and solicited comment on
whether a better threshold could be used to identify those who are
contributing to the quality of care for patients in the inpatient
setting without creating unnecessary or inappropriate barriers to
eligibility for facility-based measurement.
We explained in the proposed rule our rationale and reasoning for
these first two proposals as being based in large part on our analysis
of the previously finalized policy for eligibility for the facility-
based measurement scoring option. Using claims data, we had identified
all clinicians that would be MIPS eligible as either an individual or
group, and identified the POS codes submitted for PFS services provided
by those clinicians. We then modeled the existing final policy based on
inpatient and ER services. Although almost all ER physicians would be
scored under facility-based measurement, a relatively small percentage
of clinicians in other specialties, even those which we expected to
have significant presence in the hospital, would be eligible for the
facility-based measurement scoring option. For example, only 13.45
percent of anesthesiologists would be eligible for the facility-based
measurement scoring option under the policy finalized in the CY 2018
Quality Payment Program final rule. Adding the on-campus outpatient
hospital POS code substantially increased eligibility for the facility-
based measurement scoring option in our modeling, even after we
adjusted for requiring one service with the inpatient or emergency
department POS. Under our proposal, our model illustrated that 72.55
percent of anesthesiologists would be eligible. However, the model did
not show that the proposal would substantially increase the number of
clinicians eligible for the facility-based measurement scoring option
who, based on specialty identification, may not have a significant
presence in the hospital. For example, the modeling of the proposed
policy projected an increase in the percentage of family physicians
eligible for the facility-based measurement scoring option from 11.34
percent to 13.86 percent, which is still a very small percentage of
those clinicians.
Third, we proposed to add a new criterion (to be codified at Sec.
414.1380(e)(2)(i)(C)) that stated to be eligible for facility-based
measurement, we must be able to attribute a clinician to a particular
facility that has a value-based purchasing score (83 FR 35957 through
35958). We explained in the proposed rule how, for facility-based
measurement to be applicable, we must be able to attribute a clinician
to a facility with a value-based purchasing score. Based on our
definition of facility-based measurement, we stated that this means a
clinician must be associated with a hospital with a Hospital VBP
Program Total Performance Score. We explained our concern that the
proposed expansion of eligibility for facility-based measurement would
increase the number of clinicians eligible for facility-based
measurement but to whom we would be unable to attribute the performance
of a particular facility that has a value-based purchasing score. As we
noted in the CY 2018 Quality Payment Program final rule (82 FR 53766),
some hospitals do not have a Hospital VBP Program Total Performance
Score that could be used to determine a MIPS quality and cost
performance category score, such as hospitals in the state of Maryland.
Hence, clinicians associated with those hospitals would not be able to
use facility-based measurement but could report quality measures
through another method and have cost measures calculated if applicable.
We explained that, under our proposal, a similar result, although
relatively rare, would happen if we could not attribute a clinician
identified as facility-based to a specific facility; those clinicians
who are identified as facility-based but whom we cannot attribute to a
hospital would have to participate in MIPS quality reporting through
another method, or they would receive a score of zero in the quality
performance category. Therefore, we proposed to add the requirement to
Sec. 414.1380(e)(2)(i)(C) that a clinician must be able to be
attributed to a particular facility with a value-based purchasing score
under the methodology specified in Sec. 414.1380(e)(5) to be eligible
for facility-based measurement. The cross-reference to paragraph (e)(5)
is to the methodology we also proposed for determining the applicable
facility score to be used. Our proposed new regulatory text at Sec.
414.1380(e)(2)(i)(C) addresses both attribution to a facility and the
need for that facility to have a value-based purchasing score by
conditioning eligibility for facility-based scoring for an individual
clinician on the clinician being attributed under the methodology in
paragraph (e)(5) to a facility with a value-based purchasing score.
Fourth, we proposed to change the dates of determining eligibility
for facility-based measurement (83 FR 35958). In section III.M.3.b. of
the proposed rule, we proposed to modify the dates of the MIPS
determination period that would provide eligibility determination for
small practice size, non-patient facing, low-volume threshold, ASC,
hospital-based, and facility-based determination periods. To align this
regulation controlling facility-based scoring with these other
determination periods, we proposed that CMS would use data from the
initial 12-month segment beginning on October 1 of the calendar year 2
years prior to the applicable performance period and ending on
September 30 of the calendar year preceding the applicable performance
period, with a 30-day claims run out, in determining eligibility for
facility-based measurement.

[[Page 59859]]

The following is a summary of the public comments received on these
proposals and our responses:
Comment: Many commenters supported the four proposed changes to the
determination of a facility-based individual.
Response: We appreciate the commenters' support.
Comment: One commenter recommended that CMS include the place of
service code used for the off-campus outpatient hospital (POS code 19)
in determining individual eligibility for facility-based measurement,
noting that many clinicians work in both on-campus and off-campus
outpatient hospital settings. The commenter further suggested the
inclusion of the measures from the Hospital Outpatient Quality
Reporting Program.
Response: While we are finalizing our proposal to add on the on-
campus outpatient code (POS code 22), we disagree that the off-campus
outpatient hospital setting (POS code 19) indicates that a clinician
has a significant impact on the quality and cost within an inpatient
hospital setting in the way that POS code 22 might. A clinician may
work at an off-campus outpatient hospital setting that is miles from
the hospital and not have any involvement with patients that are
hospitalized. We do not believe the Hospital VBP Program measures,
which reflect the quality of care furnished to patients in hospitals in
inpatient settings, are applicable to (or relate to the performance of)
those clinicians who primarily bill within the off-campus outpatient
hospital setting; therefore, we do not believe such clinicians should
be eligible for facility-based measurement.
While the measures used in the Hospital Outpatient Quality
Reporting Program do reflect quality for the off-campus outpatient
hospital, section 1848(q)(2)(C)(ii) of the Act provides that we may not
use measures for hospital outpatient departments, except in the case of
items and services furnished by emergency physicians, radiologists, and
anesthesiologists. Our determination of facility-based measurement does
not consider the specialty of clinicians, so we therefore do not
believe it is appropriate or consistent with the statutory authority to
add this setting or these measures at this time.
Comment: One commenter recommended that the threshold of services
required to be provided in facilities to be eligible for facility-based
measurement be reduced from 75 percent to more than 50 percent of
services, because clinicians often work in multiple settings.
Response: As we stated in the CY 2018 Quality Payment Program final
rule (82 FR 53757), we believe the 75 percent threshold is appropriate
to use because it is similar to our determination of hospital-based
eligible clinicians in the Promoting Interoperability performance
category. In the context of our proposal to change the eligibility
criteria for facility-based measurement, we still believe that a 75
percent threshold indicates that a clinician is spending much of their
clinical time working in a hospital and the quality of their work is
reflected in that setting. Clinicians who work in more varied settings
may be better measured through another method of participating in MIPS.
Comment: One commenter recommended that CMS not include the
requirement to bill at least a single service with the POS code used
for the inpatient hospital or emergency room as this requirement could
easily be gamed.
Response: We continue to believe that that using a single service
as the threshold provides a simple, bright line to differentiate those
who never provide inpatient services from clinicians that do provide
inpatient services, as well as outpatient services. We will monitor
this requirement and may consider changing it in future rulemaking if
we find evidence or examples of gaming, such as that clinicians are
providing services in the inpatient setting primarily so they may meet
the requirements of facility-based measurement.
Comment: Several commenters supported the facility-based
measurement and the proposed policies because this option would reduce
burden and recognize the joint accountability for measures in the
hospital environment.
Response: We appreciate the commenters' support as we begin to
implement facility-based measurement in the 2019 MIPS performance
period/2021 MIPS payment year.
Comment: Several commenters requested that CMS provide more data
analysis on the implementation of facility-based measurement. A few
commenters noted concerns with how the facility-based scoring option
could contribute to an uneven playing field. Commenters' concerns
highlighted that automatically applying a quality and cost score
eliminates incentives to coordinate care which may place these
clinicians at an unfair advantage over those who must report on
measures and take steps to perform well on those measures. Hence,
commenters encouraged CMS to closely monitor the impact of the
facility-based scoring option policy. One commenter suggested that CMS
provide more data on how MIPS eligible clinicians might score in the
facility-based scoring option. Another commenter suggested that CMS
provide data on the percentage of certain specialists who would be
eligible. A few commenters suggested that CMS should closely monitor
how facility-based measurement impacts total MIPS scores between
specialties and groups working within the same hospital, as well as the
effect of facility-based measurement on those who are not eligible. One
commenter suggested that CMS provide more information via educational
resources; another commenter requested that CMS explain how the
Hospital VBP Program Total Performance Score is converted into MIPS
scoring and requirements for group reporting options.
Response: We recognize the value of data analysis when developing
additional scoring options for MIPS eligible clinicians. We continue to
believe that the facility-based scoring option will reduce
administrative burden by streamlining reporting and allowing clinicians
to focus on quality improvement. We disagree that clinicians have an
advantage under facility-based scoring option given that we have
established an eligibility threshold to identify those clinicians that
have a significant impact on the care delivered within the facility and
the facility's performance under the Hospital VBP Program. The scoring
methodology developed for facility-based measurement translates scores
in the Hospital VBP Program to scores in the Quality and Cost
performance category. Because that translation takes into account the
distribution of scores in the Hospital VBP program, which is analogous
to the distribution of scores in MIPS, clinicians who are scored using
facility-based measurement will have a similar range of scores as those
who are not eligible for facility-based measurement. We will continue
to monitor the impact of the finalized facility-based scoring policies
in efforts to avoid unfair advantages within the MIPS program.
Comment: Several commenters expressed concern about the
availability of facility-based measurement beginning in the 2019 MIPS
performance period/2021 MIPS payment year. The commenters expressed
concern that the measures included in the Hospital VBP Program were not
representative of the care provided by clinicians and would distract
from efforts to focus on measures on which these clinicians could have
an effect. A few commenters

[[Page 59860]]

supported facility-based measurement as a short-term solution to
reducing administrative burden for clinicians who primarily work within
an inpatient setting but encouraged movement towards measures that are
more meaningful for certain specialists who also predominantly work
within an inpatient setting.
Response: We recognize that the Hospital VBP Program was not
designed to measure clinicians' performance but rather hospitals'
performance. However, we believe that by using the established 75
percent threshold to identify clinicians as eligible for facility-based
scoring, we are distinguishing between those clinicians who ultimately
have a significant impact on the hospital's performance score for the
care and cost rendered within that facility versus those who do not. We
therefore believe that the Hospital VBP Program measures do reflect the
performance of the clinicians in a team-based environment. We note that
there may be more opportunities for clinicians, particularly
specialists who wish to report on more clinically meaningful measures,
to participate in MIPS using qualified registries or QCDRs that may be
related to care provided to those specific patients in a facility
setting, and we encourage clinicians who find the MIPS measures more
meaningful in the context of their patient population to report in that
manner.
After consideration of the public comments, we are finalizing our
proposals to add the on-campus outpatient hospital (POS code 22) to the
list of sites of service used to determine eligibility for facility-
based measurement and to require that clinicians bill at least a single
service with the POS codes for inpatient hospital or the emergency room
in order to be eligible for facility-based measurement as reflected in
the regulation text at Sec. 414.1380(e)(2)(i)(A) and (B). We are also
finalizing our proposal that we must be able to attribute a clinician
to a particular facility that has a value-based purchasing score under
the methodology specified in Sec. 414.1380(e)(5) to meet eligibility
for facility-based measurement as codified at Sec.
414.1380(e)(2)(i)(C). We are also finalizing our proposed policy that
CMS would use data from the initial 12-month segment beginning on
October 1 of the calendar year 2 years prior to the applicable
performance period and ending on September 30 of the calendar year
preceding the applicable performance period, with a 30-day claims run
out to determine eligibility for facility-based measurement.
(C) Facility-Based Measurement by Group
In the CY 2018 Quality Payment Program final rule (82 FR 53757), we
finalized at Sec. 414.1380(e)(2)(ii) that a MIPS eligible clinician is
eligible for facility-based measurement under MIPS if they are
determined to be facility-based as part of a group. We established at
Sec. 414.1380(e)(2)(ii) that a facility-based group is a group in
which 75 percent or more of its eligible clinician NPIs billing under
the group's TIN meet the requirements at Sec. 414.1380(e)(2)(i) (82 FR
53758). We did not propose any changes to the determination of a
facility-based group but acknowledged that our proposal to change how
individual clinicians are determined to be eligible for facility-based
measurement will necessarily have a practical impact for practice
groups. For more of the statutory background and descriptions of our
current policies on determining a facility-based group, we refer
readers to the CY 2018 Quality Payment Program final rule (82 FR 53757
through 53758).
(iii) Facility Attribution for Facility-Based Measurement
In the CY 2018 Quality Payment Program final rule (82 FR 53759), we
finalized at Sec. 414.1380(e)(5) a method to identify the hospital
whose scores would be associated with a MIPS eligible clinician or
group for purposes of facility-based measurement scoring. However,
because of a discrepancy in the preamble and the proposed regulation
text in the CY 2018 Quality Payment Program proposed rule (82 FR
53759), we indicated we would address this issue as part of the next
Quality Payment Program rulemaking cycle. Under the current regulation
text Sec. 414.1380(e)(5), a facility-based clinician or group receives
a score under the facility-based measurement scoring standard derived
from the value-based purchasing score for the facility at which the
clinician or group provided services to the most Medicare beneficiaries
during the year claims are drawn (that is, the 12-month period
described in paragraph (e)(2)). Although we did not propose any
changes, we are revising this section to replace the word ``segment''
with ``period'' for clarity purposes.
If an equal number of Medicare beneficiaries are treated at more
than one facility, then we will use the value-based purchasing score
for the highest-scoring facility (82 FR 53759 through 53760). For more
of the statutory background and descriptions of our current policies
for attributing a facility to a MIPS eligible clinician, we refer
readers to the CY 2018 Quality Payment Program final rule (82 FR 53759
through 53760).
In considering the issue of facility attribution for a facility-
based group, we stated in the CY 2019 PFS proposed rule that we believe
that a change to facility-based attribution is appropriate to better
align the policy with the determination of a facility-based group at
Sec. 414.1380(e)(2)(ii). A facility-based group is one in which 75
percent or more of the eligible clinician NPIs billing under the
group's TIN are eligible for facility-based measurement as individuals.
Additionally, under the current regulation, the value-based purchasing
score for the highest scoring facility would be used in the case of a
tie among the number of facilities at which the group provided services
to Medicare beneficiaries. We proposed to revise Sec. 414.1380(e)(5)
to differentiate how a facility-based clinician or group receives a
score based on whether they participate as a clinician or a group (83
FR 35958).
We proposed to remove ``or group'' from Sec. 414.1380(e)(5) and
redesignate that paragraph as (e)(5)(i) so that it only applies to
individual MIPS eligible clinicians (83 FR 35958). Under our proposal,
newly redesignated paragraph (e)(5)(i) would retain the rule for
facility attribution for an individual MIPS eligible clinician as
finalized in the CY 2018 Quality Payment Program final rule; we also
proposed a few minor edits to the paragraph for grammar and to improve
the sentence flow. We also proposed to add a new paragraph (e)(5)(ii)
to provide that a facility-based group receives a score under the
facility-based measurement scoring standard derived from the value-
based purchasing score for the facility at which the plurality of
clinicians identified as facility-based would have had their score
determined under the methodology described in Sec. 414.1380(e)(5)(i)
if the clinicians had been scored under facility-based measurement as
individuals (83 FR 35958). We made this proposal because of our wish to
emphasize the connection between an individual clinician and a
facility. We explained in the CY 2019 PFS proposed rule that using the
plurality of clinicians reinforces the connection between an individual
clinician and facility and is more easily understandable for larger
groups.
The following is a summary of the public comments received on these
proposals and our responses:
Comment: A few commenters suggested that CMS consider additional
rules or standards for attribution of a

[[Page 59861]]

clinician or group to a facility for purposes of using that facility's
Total Performance Score. One commenter requested that CMS consider
using an eligible clinician's/group's second most utilized facility in
cases where the top utilized facility does not have a Hospital VBP
Program Total Performance Score. Another commenter encouraged CMS
develop a group level attribution methodology to account for groups
that practice in multiple sites and the commenter believed that an
accountability model will be more meaningful and actionable for these
groups.
Response: We are finalizing our proposal that if we are unable to
identify a particular facility with a value-based purchasing score
under the methodology specified in Sec. 414.1380(e)(5), such as those
facilities in the state of Maryland, to attribute for use as an
individual clinician's performance, then that clinician is not eligible
for facility-based measurement. We are concerned that using a hospital
other than the most utilized could result in assigning a score based on
a hospital at which the clinician rarely works. For example, in the
case of using the second most utilized facility, an individual
clinician may have primarily worked in the facility without a Hospital
VBP Program Total Performance Score and then only have seen a single
patient at the second most utilized hospital with a Hospital VBP Total
Performance Score. However, we will consider looking into this issue in
future rulemaking, including whether it may be appropriate to allow for
the score to be based upon a facility other than the one at which a
clinician provides services to the most patients.
We understand that some groups that may be facility-based include
clinicians that practice in a number of different facilities. However,
we believe this issue is similar to that experienced in other clinician
groups that may have a diversity of clinicians and settings. In section
III.I.3.e of the proposed rule (83 FR 35891), we requested comments on
developing an opportunity for clinicians to participate in MIPS as
subgroups. We believe that our consideration of that issue could inform
the determination of members of a group that practice in a single TIN
but who serve patients in many different facilities.
After consideration of the public comments, we are finalizing our
proposals to remove ``or group'' from Sec. 414.1380(e)(5); redesignate
that paragraph as (e)(5)(i) so that it only applies to individual MIPS
eligible clinicians; and add a new paragraph (e)(5)(ii) to Sec.
414.1380(e)(5) regarding group scoring methodologies in which a
facility-based group receives a score under the facility-based
measurement scoring standard derived from the value-based purchasing
score for the facility at which the plurality of clinicians identified
as facility-based would have had their score determined under the
methodology described in Sec. 414.1380(e)(5)(i) if the clinicians had
been scored under facility-based measurement as individuals.
(iv) No Election of Facility-Based Measurement
In the CY 2018 Quality Payment Program final rule (82 FR 53760), we
did not finalize our proposal for how individual MIPS eligible
clinicians or groups who wish to have their quality and cost
performance category scores determined based on a facility's
performance would elect to do so through an attestation. We did
finalize, and reflect in the introductory text at Sec. 414.1380(e),
that an individual clinician or group would elect to use a facility-
based score. In the CY 2019 PFS proposed rule (82 FR 53760), we
specified that such clinicians or groups would be required to submit
their election during the data submission period through the
attestation submission mechanism established for the improvement
activities and the Promoting Interoperability performance categories.
An alternative approach, which likewise was not finalized, did not
require an election process, but instead would have automatically
applied a facility-based measurement to MIPS eligible clinicians and
groups who met the eligibility criteria for facility-based measurement,
if such an application were technically feasible (82 FR 53760). We
noted in the CY 2018 Quality Payment Program final rule (82 FR 53760)
that we would examine both the attestation process and the opt-out
process, and work with stakeholders to identify a new proposal in
future rulemaking. We explained in the CY2018 Quality Payment Program
final rule (82 FR 53760) our interest in a process that would impose
less burden on clinicians than an attestation requirement and requested
comment on automatically assigning a clinician or group a facility-
based score, but with a notice and opportunity to opt-out of facility-
based measurement. We summarized those comments in the CY 2019 PFS
proposed rule (83 FR 35958).
After further considering the advantages and disadvantages of an
opt-in or an opt-out process, we proposed a modified policy that would
not require an election process. We proposed to automatically apply
facility-based measurement to MIPS eligible clinicians and groups who
are eligible for facility-based measurement and who would benefit by
having a higher combined quality and cost performance category score
(83 FR 35959). Under our proposal, if the MIPS eligible clinician or
group is eligible for facility-based measurement, we would calculate a
combined quality and cost performance category score. We proposed to
use the facility-based score to determine the MIPS quality and cost
performance category scores, unless we received another submission of
quality data for or on behalf of that clinician or group and the
combined quality and cost performance category score for the other
submission results in a higher combined quality and cost performance
score. If the other submission has a higher combined quality and cost
performance score, then we would not apply the facility-based
performance scores for either the quality or cost performance
categories (83 FR 35959). Under our proposal, the combined score for
the quality and cost performance categories would determine the scores
to be used for both the quality and cost performance categories, for
both individual clinicians and for groups that meet the requirements of
paragraph (e)(2). We did not propose to adopt a formal opt-out process
because, under our proposal, the higher of the combined quality and
cost performance scores for the clinician or clinician group would be
used, which would only benefit the clinician or group. We explained in
the proposed rule our strong commitment to reducing burden as part of
the Quality Payment Program and that we believe that requiring a
clinician or group to elect a measurement process (or to opt-out of a
measurement process) based on facility performance would add
unnecessary burden.
In MIPS, we score clinicians as individuals unless they submit data
as a group. We stated in the proposed rule that the same policy should
apply to facility-based measurement, even though there are no
submission requirements for the quality performance category for
individuals under facility-based measurement. We proposed to revise
Sec. 414.1380(e)(4) to state that there are no submission requirements
for individual clinicians in facility-based measurement, but a group
must submit data in the improvement activities or Promoting
Interoperability performance categories in order to be measured as a
group under facility-based measurement. We explained how, if a group
does not

[[Page 59862]]

submit improvement activities or Promoting Interoperability measures,
we would apply facility-based measurement to the individual clinicians
and such clinicians would not be scored as a group under our proposal.
In the case of virtual groups, MIPS eligible clinicians will have
formed virtual groups prior to the MIPS performance period; as a
result, virtual groups eligible for facility-based measurement will
always be measured as a virtual group (83 FR 35959). Although we can
calculate a score for a TIN without the submission of data by the TIN,
we would not be certain if the clinicians in that group actually wanted
to be measured as a group without an active submission (in other words,
if the group did not submit data as a group). As we explained in the
proposed rule, we view submission of data on the improvement activities
or Promoting Interoperability measures as an indication by the
clinicians in that group that they want to be scored as a group; using
the choice to submit data as a group to identify a group in the context
of facility-based scoring would preserve and respect choices made by
clinicians and groups while avoiding the burden of an election process
to be scored as a group solely for the purpose of facility-based
scoring. We solicited comment specifically on this proposal and other
means to achieve the same ends.
In the CY 2018 Quality Payment Program final rule, we established
that if a clinician or group elects facility-based measurement but also
submits MIPS quality data, then the clinician or group would be
measured on the method that results in the higher quality score (82 FR
53767). We proposed to adopt this same scoring principle in conjunction
with our proposal not to use (or require) an election process.
Therefore, we proposed at Sec. 414.1380(e)(6)(vi) that the MIPS
quality and cost score for clinicians and groups eligible for facility-
based measurement would be based on the facility-based measurement
scoring methodology described in Sec. 414.1380(e)(6) unless the
clinician or group receives a higher combined score for the MIPS
quality and cost performance categories through data submitted to CMS
for MIPS (83 FR 35959). We stated in the proposed rule that this policy
is not applicable to any MIPS eligible clinicians scored under the APM
scoring standard described at Sec. 414.1370; we further clarify here
that this includes Shared Savings Program participant TINs in ACOs that
have failed to complete web interface reporting, unless these measures
are specifically required under the terms of the applicable APM.
We also proposed conforming changes in two other sections of
regulatory text. We proposed to revise the introductory text at Sec.
414.1380(e) to remove ``elect to,'' and therefore, reflect that
clinicians and groups who are determined to be facility-based will
receive MIPS quality and cost performance categories under the
methodology in paragraph (e) (83 FR 35959 through 35960). Because of
our proposal to not require clinicians to opt-in into facility-based
measurement, we acknowledged that there may be clinicians that will
continue to submit data via other methods. We explained that these
clinicians and groups are not prohibited from submitting quality
measures to CMS for purposes of MIPS. However, under our proposal, if a
higher combined quality and cost score is achieved using data submitted
to CMS for purposes of MIPS, then we will use the MIPS scores based on
the submission. We also proposed to revise Sec. 414.1380(e)(4) and
(e)(6)(v)(A) to reflect that facility-based measurement does not
require election and to replace the phrase ``clinicians that elect
facility-based measurement'' with ``clinicians and groups scored under
facility-based measurement'' (83 FR 35960) as part of this policy.
The following is a summary of the public comments received on these
proposals and our responses:
Comment: Many commenters supported our proposal to automatically
apply facility-based measurement to MIPS eligible clinicians and groups
who are eligible for facility-based measurement and who would benefit
by having a higher combined quality and cost performance category
score.
Response: We thank the commenters for their support.
Comment: A few commenters opposed our proposal to require a group
to submit information in the improvement activities or Promoting
Interoperability performance categories to be measured as a facility-
based group. A few of these commenters requested that rather than
requiring the submission of information in these categories, CMS offer
an election process. One commenter questioned how a group that was
excluded from both the improvement activities and Promoting
Interoperability performance categories could participate as a
facility-based group. One commenter suggested that it would be
difficult to complete an improvement activity if members of the group
practice at more than one facility.
Response: We continue to believe that our proposal of a clinician
receiving the higher of the quality and cost performance score
available would only benefit the individual MIPS eligible clinician or
group. If we do not require groups to submit data in the improvement
activity or Promoting Interoperability performance categories, then we
will be unable to tell whether the clinician should be measured as part
of a group. We will consider whether there would be an opportunity for
a facility-based group to elect to participate without submitting data
on another performance category in the future as feasible. We do not
believe that we would need to establish additional policies for groups
that would have their improvement activities performance score re-
weighted specifically because we generally expect reweighting to occur
for the improvement activities performance category only in rare cases
of extreme and uncontrollable events. We do note that the clinicians in
a facility-based group who meet the requirements for facility-based
measurement as individuals will have scores in the quality and cost
performance categories determined for them as individuals if there is
no data submission from the group in the improvement activity or
Promoting Interoperability performance categories.
Comment: Commenters encouraged CMS to provide as much information
as possible to eligible clinicians including information on eligibility
for facility-based measurement, clinician type, potential performance
score under facility-based scoring, and to which facility the eligible
clinician will be attributed. Several commenters noted that more
information would give clinicians the opportunity to assess the
advantages and disadvantages of various reporting options under MIPS.
One commenter stated that more information will avoid confusion as to
how the facility-based scoring option will work during the performance
period. A few commenters noted concerns with the timing of receiving
information about facility-based measurement. Some commenters noted the
risk of a clinician assuming that he or she will meet the criteria for
facility-based measurement when that may not be the case. Another
commenter noted that the timing is important in making decisions as to
whether to report as a group or an individual under the facility-based
scoring option.
Response: We intend to provide as much information as possible as
early as possible to clinicians about their eligibility and the
hospital performance upon which a MIPS eligible clinician's score would
be based. We acknowledge

[[Page 59863]]

that clinicians may want to consider this information to make financial
and operational decisions, regardless of not having to be required to
opt-in to facility-based scoring. We intend to provide additional
information to clinicians regarding their status with facility-based
measurement eligibility, facility attribution, and a preview score
based on data from the previous performance period. We anticipate that
this information will be released during the first quarter of the
performance period, if technically feasible, beginning with the 2019
performance period, and we aim to notify clinicians as soon as this
information is available.
Comment: Many commenters expressed concern with our proposal to not
require an opt-in or offer an opt-out for facility-based measurement. A
few commenters noted that performing this calculation automatically
would reduce the control that clinicians have over their participation
in MIPS. A few commenters suggested that automatically calculating a
score for facility-based clinicians would reduce the incentive to
participate in clinical data registries. A few commenters suggested
that not requiring an opt-in would provide a performance advantage to
facility-based clinicians over those who are not eligible for facility-
based measurement. One commenter expressed concern that clinicians
could have measures displayed on Physician Compare from facility-based
measurement.
Response: Receiving the higher of the combined quality and cost
performance scores available would only benefit the applicable
individual MIPS eligible clinician or group; however, we are uncertain
that facility-based clinicians would necessarily perform better than
those who submit MIPS data, because the opportunity to submit data via
other methods provides individual clinicians or groups the opportunity
to select quality measures. We continue to believe that adding a formal
opt-in or opt-out process would add unnecessary burden for both
individual clinicians and groups. Additionally, we believe that those
MIPS eligible clinicians who will not be required to submit MIPS data
will benefit from a reduction in administrative burden while being
measured in a facility in which their care has a significant impact on
the facility's performance. We note that clinicians who wish to better
control their performance in MIPS may submit measures through another
method. Hence, we are finalizing our proposal to not require an opt-in
or opt-out for facility-based measurement. Additionally, we did not
propose any policies for how facility-based measures, other than the
scores derived from those measures and included as quality and cost
performance category scores, will be displayed on Physician Compare,
but we thank commenters for their input and will take this input into
consideration in future years.
Comment: One commenter requested clarification on how CMS would
score a facility-based clinician who submits data on the quality
performance category but does not have a cost performance category
score, and thus, the cost performance category weight would need to be
redistributed to the quality performance category.
Response: The cost performance category can be reweighted to 0
percent if there are not sufficient cost measures applicable and
available (for example, if the clinician does not meet the minimum case
requirements for the cost measures). In cases in which a clinician or
group does not have a score in the cost performance category, in
general, the weight of the cost performance category would be
redistributed to the quality performance category. In that case, the
points assigned under Sec. 414.1380(b) for purposes of calculating/
assigning the MIPS final score in the cost and quality categories will
be compared to the points that contribute to the final score from the
quality and cost scores established under facility-based measurement.
For example, a clinician whose data was submitted on their behalf by a
third-party intermediary and received a MIPS quality performance
category percent score of 50 percent but did not meet the case minimum
for cost measures, would have a total of 30 points as the combined
score for the quality and cost performance categories. If that same
clinician were eligible for facility-based measurement, the score based
on that third party intermediary submission would be used unless the
combination of the quality and cost scores established under facility-
based measurement (as calculated under Sec. 414.1380(e)(6)) resulted
in more than 30 points towards the final score.
Comment: One commenter requested guidance and language as to how to
account for MIPS eligible clinicians who wish to use their facility's
Hospital VBP Program Total Performance Score for the quality and cost
performance categories, yet still use a QCDR to report.
Response: Our proposed policy to not require an opt-in or offer an
opt-out for facility-based measurement anticipates that there may be
some clinicians and groups who will both receive a score based upon
facility-based measurement and submit quality measures via various
collection types. These clinicians may believe these quality measures
better represent their performance or that they will perform better
submitting these measures. In all cases, under the policy we are
finalizing here, we will compare combined performance in these two
categories and assign the clinician or group the higher combined score,
whether based on the facility-based measurement or through another
submission type. We note that facility-based measurement only applies
to the quality and cost performance categories; the Promoting
Interoperability and improvement activity performance categories would
still require reporting on the part of the clinicians or group.
After consideration of the public comments, we are finalizing our
proposal to automatically apply facility-based measurement to MIPS
eligible clinicians and groups who are eligible for facility-based
measurement and those who have a higher combined quality and cost
performance category score. Additionally, we are finalizing our
proposal to revise Sec. 414.1380(e)(4) to state that there are no
submission requirements for individual clinicians in facility-based
measurement and that a group must submit data in the improvement
activities or Promoting Interoperability performance categories to be
measured as a group under facility-based measurement. Additionally, we
are also revising the proposed regulation text for Sec. 414.1380(e)(4)
by adding ``to be'' between ``clinicians'' and ``scored'' to clarify
that this paragraph is establishing the data submissions necessary for
facility-based scoring to be possible as opposed to a provision
governing MIPS reporting as a whole for all categories. We are also
finalizing the conforming changes at Sec. 414.1380(e)(4) and (e)(6) to
revise text that referred to an election by the clinician or group to
use facility-based scoring. Additionally, while we did not propose any
changes, we are revising Sec. 414.1380(e) to state, for the payment in
2021 MIPS payment year and subsequent years and subject to paragraph
(e)(6)(vi) of this section, a MIPS eligible clinician or group will be
scored under the quality and cost performance categories under the
methodology described in this paragraph (e). These technical changes
are made to conform to our policy in this section to not require or
offer an election and to improve readability.
(v) Facility-Based Measures
(A) Background
Section 1848(q)(2)(C)(ii) of the Act provides that the Secretary
may use

[[Page 59864]]

measures used for payment systems other than for physicians, such as
measures for inpatient hospitals, for purposes of the quality and cost
performance categories. However, the Secretary may not use measures for
hospital outpatient departments, except in the case of items and
services furnished by emergency physicians, radiologists, and
anesthesiologists. In the CY 2018 Quality Payment Program proposed
rule, we proposed to include for the 2020 MIPS payment year all the
measures adopted for the FY 2019 Hospital VBP Program on the MIPS list
of quality measures and cost measures for purposes of facility-based
measurement (82 FR 30125). We noted how these measures meet the
definition of additional system-based measures provided in section
1848(q)(2)(C)(ii) of the Act (82 FR 30125). In the CY 2018 Quality
Payment Program final rule, we did not finalize our proposal that the
facility-based measures available for the 2018 MIPS performance period
would be the measures adopted for the FY 2019 Hospital VBP Program; nor
did we finalize our proposal that, for the 2020 MIPS payment year,
facility-based individual MIPS eligible clinicians or groups that were
attributed to a facility would be scored on all measures on which the
facility is scored via the Hospital VBP Program's Total Performance
Score methodology (82 FR 53762).
We did finalize a facility-based measurement scoring standard but
not the specific instance of using the FY 2019 Hospital VBP Program
Total Performance Score methodology (82 FR 53755). We expressed our
belief that using all measures from the Hospital VBP Program is
appropriate; nevertheless, because we did not finalize the facility-
based measurement scoring option for the 2018 MIPS performance period/
2020 MIPS payment year, it was not appropriate to adopt these policies
at that time (82 FR 53762 through 53763). We noted that we intended to
propose measures that would be available for facility-based measurement
for the 2019 MIPS performance period/2021 MIPS payment year in future
rulemaking (82 FR 53763).
(B) Measures in Facility-Based Scoring
As we noted in the proposed CY 2019 PFS rule, we continue to
believe it is appropriate to adopt all the measures for the Hospital
VBP Program into MIPS for purposes of facility-based scoring; these
Hospital VBP Program measures meet the definition of additional system-
based measures provided in section 1848(q)(2)(C)(ii) of the Act. We
also stated how it is appropriate to adopt the performance periods for
the measures, which generally are consistent with the dates that we use
to determine eligibility for facility-based measurement.
Beginning with the 2019 MIPS performance period, we proposed at
Sec. 414.1380(e)(1)(i) to adopt for facility-based measurement, the
measure set that we finalize for the fiscal year Hospital VBP Program
for which payment begins during the applicable MIPS performance period.
For the 2019 MIPS performance period (which runs on the 2019 calendar
year), we proposed to adopt the FY 2020 Hospital VBP Program measure
set, for which payment begins on October 1, 2019. The performance
period for these measures varies but performance ends in 2018 for all
measures.
We also proposed at Sec. 414.1380(e)(1)(ii) that, starting with
the 2021 MIPS payment year, the scoring methodology applicable for MIPS
eligible clinicians scored with facility-based measurement is the Total
Performance Score methodology adopted for the Hospital VBP Program, for
the fiscal year for which payment begins during the applicable MIPS
performance period. Additionally, we note a typographical error in the
CY 2019 PFS proposed rule (83 FR 35960) in which we state FY 2019
instead of FY 2020, which we believe commenters have likely understood
given the comments we have received on FY 2020 measures. However, we
provide additional clarification in this final rule.
We noted in the proposed rule that this approach of adopting all
the measures in the Hospital VBP Program can be applied to other value-
based purchasing programs in the future, should we decide to expand
facility-based measurement to settings other than hospitals.
In the CY 2018 Quality Payment Program final rule we also
established at Sec. 414.1380(e)(6)(i) that the available quality and
cost measures for facility-based measurement are those adopted under
the value-based purchasing program of the facility for the year
specified. We established at Sec. 414.1380(e)(6)(ii) that we will use
the benchmarks adopted under the value-based purchasing program of the
facility program for the year specified (82 FR 53763 through 53764). We
noted that we would determine the particular value-based purchasing
program to be used for facility-based measurement in future rulemaking
but would routinely use the benchmarks associated with that program (82
FR 53764). Likewise, at Sec. 414.1380(e)(6)(iii), we established that
the performance period for facility-based measurement is the
performance period for the measures adopted under the value-based
purchasing program of the facility program for the year specified (82
FR 53755). We noted that these provisions referred to the general
parameters of our method of facility-based measurement and that we
would address specific programs and years in future rulemaking (82 FR
53763). For the CY 2019 performance period, we proposed regulation text
for these three provisions to specify that the measures, performance
period, and benchmark period for facility-based measurement are the
measures, performance period, and benchmark period established for the
value-based purchasing program used to determine the score as described
in Sec. 414.1380(e)(1) (83 FR 35960). We provided an example in the
proposed rule to illustrate this policy: For the 2019 MIPS performance
period and 2021 MIPS payment year, the measures used would be those for
the FY 2019 Hospital VBP Program along with the associated benchmarks
and performance periods. As explained earlier, we intended this to mean
that for the 2019 MIPS performance period and 2021 MIPS payment year,
the measures used would be those for the FY 2020 Hospital VBP Program
along with the associated benchmarks and performance periods.
The following is a summary of the public comments received on these
proposals and our responses:
Comment: Several commenters noted their appreciation of the
facility-based scoring option but requested that CMS consider
additional measures that are more relevant to specific specialties as
that would capture clinically meaningful information. One commenter
suggested CMS develop episode-based risk adjusted measures even if they
are not used in the Hospital VBP Program. Another commenter suggested
that CMS consider additional avenues to collect more meaningful
information.
Response: Section 1848(q)(2)(C)(ii) of the Act provides that the
Secretary may use measures used for payment systems other than for
physicians, such as measures for inpatient hospitals, for purposes of
the quality and cost performance categories. Based on this statutory
requirement and because we want to align incentives between clinicians
and hospitals, we proposed to use measures that are developed and
implemented in other programs, as opposed to new measures that reflect
a facility's performance. Due to this limitation, we note that there
may be additional avenues for clinicians to participate in MIPS using
qualified

[[Page 59865]]

registries or QCDRs that measure quality for services that may be
provided in a facility setting, such as inpatient surgeries, without
being measured in facility-based measurement.
After consideration of the public comments, we are finalizing the
proposed regulation text at Sec. 414.1380(e)(1)(i) that the measures
for facility-based measurement will be the measure set finalized for
the fiscal year value-based purchasing program for which payment begins
during the applicable MIPS performance period. We are also finalizing
the proposed regulation text at Sec. 414.1380(e)(1)(ii) that,
beginning with the 2021 MIPS payment year, the scoring methodology
applicable for MIPS eligible clinicians scored with facility-based
measurement is the Total Performance Score methodology adopted for the
Hospital VBP Program for the fiscal year for which payment begins
during the applicable MIPS performance period. This means that for the
2021 MIPS payment year, the Total Performance Score for FY 2020 will be
applied for the MIPS performance year 2019. Additionally, while we did
not propose any changes, we are revising the regulation text at Sec.
414.1380(e)(1)(i) to stated that the measures used for facility-based
measurement are the measure set finalized for the fiscal year VBP
program for which payment begins during the applicable MIPS performance
period. This update is not intended to be substantive in nature, but
rather to bring more clarity to the regulatory text. We have also made
a technical revision in which we revise Sec. 414.1380(e)(6)(ii), (iv),
and (v) to reference only (e)(1) rather than (e)(1)(i) for improvements
in readability and clarity of the regulation.
(C) Measures for MIPS 2019 Performance Period/2021 MIPS Payment Year
For informational purposes, we provided a list of measures included
in the FY 2020 Hospital VBP Program that would be used in determining
the quality and cost performance category scores for the 2019 MIPS
performance period/2021 MIPS payment year. The FY 2020 Hospital VBP
Program has adopted 12 measures covering 4 domains (83 FR 20412 through
20413). The performance period for measures in the Hospital VBP Program
varies depending on the measure, and some measures include multi-year
performance periods. We noted in the proposed rule that these measures
are determined through separate rulemaking (83 FR 38244); the
applicable rulemaking is usually the Hospital Inpatient Prospective
Payment Systems for Acute Care Hospitals and the Long-Term Care
Hospital Prospective Payment System rule. We are using these measures,
benchmarks, and performance periods for the purposes of facility-based
measurement based on Sec. 414.1380(e)(1) as finalized here. We repeat
the list of measures finalized for the FY 2020 Hospital VBP measure set
and Total Performance Score in Table 52.

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(vi) Scoring Facility-Based Measurement
(A) Scoring Achievement in Facility-Based Measurement
In the CY 2018 Quality Payment Program final rule, we adopted
certain scoring policies for clinicians and groups in facility-based
measurement. We established at Sec. 414.1380(e)(6)(iv) and (v) that
the quality and cost performance category percent scores would be
established by determining the percentile performance of the facility
in the value-based purchasing program for the specified year, then
awarding scores associated with that same percentile performance in the
MIPS quality and cost performance categories for those MIPS eligible
clinicians who are not scored using facility-based measurement for the
MIPS payment year (82 FR 53764). We also finalized at Sec.
414.1380(e)(6)(v)(A) that clinicians scored under facility-based
measurement would not be scored on other cost measures (82 FR 53767).
For detailed descriptions of the current policies related to
scoring achievement in facility-based measurement, we refer readers to
the CY 2018 Quality Payment Program final rule (82 FR 53763). Because
we proposed to not require or allow an opt-in process for facility-
based measurement, we proposed a change to the determination of the
quality and cost performance category scores. We proposed that the
quality and cost performance category percent scores would be
established by determining the percentile performance of the facility
in the Hospital VBP Program for the specified year, then awarding a
score associated with that same percentile performance in the MIPS
quality and cost performance categories for those MIPS eligible
clinicians who are not eligible to be scored under facility-based
measurement for the MIPS payment year (83 FR 35961). Under our
proposal, the determination of percentile performance would be
independent of those clinicians who would not have their quality or
cost scores determined until we make the determination of their status
under facility-based measurement.
The following is a summary of the public comments received on these
proposals and our responses:
Comment: A few commenters supported our proposal that the quality
and cost performance category percent scores for clinicians in
facility-based measurement would be established by

[[Page 59867]]

determining the percentile performance of the facility in the Hospital
VBP Program for the specified year, then awarding a score associated
with that same percentile performance in the MIPS quality and cost
performance categories for those MIPS eligible clinicians who are not
eligible to be scored under facility-based measurement for the MIPS
payment year.
Response: We thank the commenters for their support.
After consideration of the public comments, we are finalizing our
proposal to change the determination of the quality and cost
performance category scores at Sec. 414.1380(e)(6)(iv) and (v) to
establish both scores by determining the percentile performance of the
facility in value-based purchasing program for the specified year, then
awarding a score associated with that same percentile performance in
the MIPS quality and cost performance categories for those MIPS
eligible clinicians who are not eligible to be scored under facility-
based measurement for the MIPS payment year. Also, we have revised the
last sentence in paragraphs (e)(6)(iv) and (v) to more clearly state
that a clinician or group receiving a facility-based performance score
will not earn improvement points based on prior performance in the MIPS
quality or cost categories.
(B) Scoring Improvement in Facility-Based Measurement
In the CY 2018 Quality Payment Program final rule, we finalized
that we would not give a clinician or group participating in facility-
based measurement the opportunity to earn improvement points based on
prior performance in the MIPS quality and cost performance categories;
we noted that the Hospital VBP Program already takes improvement into
account in determining the Total Performance Score (82 FR 53764 through
53765). We proposed to add this previously finalized policy to
regulatory text at Sec. 414.1380(e)(6)(iv) and (v) (83 FR 35961).
We did not address in the CY 2018 Quality Payment Program final
rule a policy for a clinician or group who participates in facility-
based measurement for one performance period, and then does not
participate in facility-based measurement in a subsequent performance
period (for example, a clinician who is scored using facility-based
measurement in the 2019 MIPS performance period and is not eligible for
facility-based measurement in the 2020 MIPS performance period). After
further considering the issue, we stated in the CY 2019 PFS proposed
rule our position that it is not possible to assess improvement in the
quality performance category for those who are measured under facility-
based measurement in 1 year and then through another method in the
following year. Our method of assessing and rewarding improvement in
the MIPS quality performance category separates points awarded for
measure performance from those received for bonus points (82 FR 53745).
Our method of determining the quality performance category score using
facility-based measurement does not allow for the separation of
achievement from bonus points. For this reason, we proposed at Sec.
414.1380(b)(1)(vi)(A)(4) \30\ to not assess improvement for MIPS-
eligible clinicians who are scored in MIPS through facility-based
measurement in 1 year but through another method in the following year
(83 FR 39561).
---------------------------------------------------------------------------

\30\ The codification was misidentified in the preamble of the
proposed rule as Sec. 414.1380(b)(1)(xi)(A)(4) but the regulation
text was proposed, at 83 FR 36081, to be codified at Sec.
414.1380(b)(1)(vi)(A)(4), where we are finalizing it.
---------------------------------------------------------------------------

We did not receive any public comments on this proposal, so we will
finalize our proposal to add regulatory text at Sec.
414.1380(e)(6)(iv) and (v) and our proposal at Sec.
414.1380(b)(1)(vi)(A)(4) to not assess improvement for MIPS-eligible
clinicians who are scored in MIPS through facility-based measurement in
1 year but through another method in the following year.
(vii) Expansion of Facility-Based Measurement To Use in Other Settings
We initiated the process of facility-based measurement focusing on
the inpatient hospital setting, but have noted in the past our policy
goal of expanding the concept into other facilities and programs and
future, in particular to use the post-acute care (PAC) and the end-
stage renal disease (ESRD) settings as the basis for facility-based
measurement and scoring. In the proposed rule, we summarized a number
of issues and topics related to the use of PAC and ESRD facilities (83
FR 35962 through 35963). We solicited comment on these topics,
including:
How to attribute the quality and cost of care for patients
in PAC settings to clinicians;
Whether using a value-based purchasing program, that is, a
similar approach to Sec. 414.1380(e)(1), could work for PAC given the
number and variation of PAC settings and clinicians;
The level of influence MIPS-eligible clinicians have in
determining performance on quality measures for individual settings and
programs in the PAC setting;
Which PAC QRP measures may be best utilized to measure
clinician performance;
Methods to identify the appropriate measures for scoring,
and what measures would be most influenced by clinicians;
Whether all measures that are reported as part of the PAC
QRPs should be included or whether we should identify a subset of
measures;
Whether we should limit facility-based measurement to
specific PAC settings and programs such as the IRF QRP or LTCH QRP, or
whether we should consider all PAC settings in the facility-based
measurement discussion;
The extent to which the quality measures of dialysis
centers reflect clinician performance; and
Practical and policy considerations related to whether we
could to attribute the performance of a specific ESRD facility to an
individual clinician.
We appreciate the comments received in response to these
considerations and may consider these suggestions in policies that will
be proposed as part of future rulemaking.
(e) Scoring the Improvement Activities Performance Category
For our previously established policies regarding scoring the
improvement activities performance category, we refer readers to Sec.
414.1380(b)(3) and the CY 2018 Quality Payment Program final rule (82
FR 53767 through 53769). We also refer readers to Sec. 414.1355 and
the CY 2018 Quality Payment Program final rule (82 FR 53648 through
53662) and CY 2017 Quality Payment Program final rule (81 FR 77177
through 77199) for previously established policies regarding the
improvement activities performance category generally.
(i) Regulatory Text Updates
In the CY 2019 PFS proposed rule, we proposed updates to both
Sec. Sec. 414.1380(b)(3) and 414.1355 to more clearly and concisely
capture previously established policies (83 FR 35963). We also proposed
one substantive change with respect to patient-centered medical homes
and comparable specialty practices (83 FR 35963). These are discussed
in more detail in this section.

[[Page 59868]]

(A) Improvement Activities Performance Category Score and Total
Required Points
In an effort to more clearly and concisely capture previously
established policies, we proposed updates to Sec. 414.1380(b)(3) and
refer readers to the CY 2019 PFS proposed rule for more details (83 FR
35963). We also clarified that the improvement activities performance
category score cannot exceed 100 percent (83 FR 35963).
We solicited comments on the above proposal. We did not receive any
comments on this proposal. We are finalizing our changes to regulation
text at Sec. 414.1380(b)(3) as proposed.
(B) Weighting of Improvement Activities
In an effort to more clearly and concisely capture previously
established policies, we proposed updates to Sec. 414.1380(b)(3) and
refer readers to the CY 2019 PFS proposed rule for more details (83 FR
35963).
We solicited comments on the above proposal. We did not receive any
comments on this proposal. We are finalizing our changes to regulation
text at Sec. 414.1380(b)(3) as proposed.
(C) APM Improvement Activities Performance Category Score
In an effort to more clearly and concisely capture previously
established policies, we proposed updates to Sec. 414.1380(b)(3)(i)
and refer readers to the CY 2019 PFS proposed rule for more details (83
FR 35963).
We solicited comments on the above proposal. We did not receive any
comments on this proposal. We are finalizing our changes to regulation
text at Sec. 414.1380(b)(3)(i) as proposed.
(D) Patient-Centered Medical Homes and Comparable Specialty Practices
In the CY 2019 PFS proposed rule (83 FR 35963), we proposed to
modify our regulations at Sec. 414.1380(b)(3)(ii) to more clearly and
concisely capture our previously established policies for patient-
centered medical homes and comparable specialty practices and refer
readers to the CY 2019 PFS proposed rule for more details.
In addition, it had come to our attention that in the preamble of
the CY 2017 Quality Payment Program final rule (81 FR 77186 and 77179),
the terminology ``automatic'' was used in reference to patient-centered
medical home or comparable specialty practice improvement activities
scoring credit. In that rule (81 FR 77186), in response to one comment,
we stated, ``. . . any MIPS eligible clinician or group that does not
qualify by October 1st of the performance year as a certified patient-
centered medical home or comparable specialty practice cannot receive
automatic credit as such for the improvement activities performance
category.'' In response to another comment in that rule (81 FR 77179),
we stated, ``Other certifications that are not for patient-centered
medical homes or comparable specialty practices would also not qualify
automatically for the highest score.''
While we used the term ``automatic'' then, we have since come to
realize it is inaccurate because an eligible clinician or group must
attest to their status as a patient-centered medical home or comparable
specialty practice in order to receive full credit for the improvement
activities performance category. In the CY 2018 Quality Payment Program
final rule (82 FR 53649), in response to comments we received regarding
patient-centered medical homes or comparable specialty practices
receiving full credit for the improvement activities performance
category for MIPS, we stated that we would like to make clear that
credit is not automatically granted; MIPS eligible clinicians and
groups must attest in order to receive the credit.
Therefore, in the CY 2019 PFS proposed rule (83 FR 35963), we
proposed codifying at Sec. 414.1380(b)(3)(ii) to require that an
eligible clinician or group must attest to their status as a patient-
centered medical home or comparable specialty practice in order to
receive this credit. Specifically, MIPS eligible clinicians who wish to
claim this status for purposes of receiving full credit in the
improvement activities performance category must attest to their status
as a patient-centered medical home or comparable specialty practice for
a continuous 90-day minimum during the performance period.
We solicited comments on the above proposal. We received the
following comment on this proposal.
Comment: One commenter supported the proposal to modify current
regulations to more clearly and concisely capture previously
established policies for patient-centered Medical Homes and comparable
specialty practices.
Response: We thank the commenter for your support.
After consideration of the comment we received, we are finalizing
our changes to regulation text at Sec. 414.1380(b)(3)(ii) as proposed.
(E) Improvement Activities Performance Category Weighting for Final
Scoring
In the CY 2019 PFS proposed rule (83 FR 35963), in an effort to
more clearly and concisely capture previously established policies, we
proposed to make technical changes to Sec. 414.1355(b) to state that
unless a different scoring weight is assigned by CMS under section
1848(q)(5)(F) of the Act, performance in the improvement activities
performance category comprises 15 percent of a MIPS eligible
clinician's final score for the 2019 MIPS payment year and for each
MIPS payment year thereafter). We stated that we believe these changes
would better align the regulation text with the text of the statute.
We solicited comments on the above proposal. We did not receive any
comments on this proposal. We are finalizing our changes to regulation
text at Sec. 414.1355(b) as proposed.
(ii) CEHRT Bonus
In the CY 2017 Quality Payment Program final rule (81 FR 77202
through 77209) and the CY 2018 Quality Payment Program final rule (82
FR 53664 through 53670), we established that certain activities in the
improvement activities performance category will qualify for a bonus
under the Promoting Interoperability performance category if they are
completed using CEHRT. This bonus is applied under the Promoting
Interoperability performance category and not under the improvement
activities performance category. In the CY 2019 PFS proposed rule (83
FR 35932), we proposed a new approach for scoring the Promoting
Interoperability performance category that is aligned with our MIPS
program goals of flexibility and simplicity. We refer readers to
section III.I.3.h.(5)(g) of this final rule for a summary of the
comments we received regarding this proposal and our responses.
(f) Scoring the Promoting Interoperability Performance Category
We refer readers to section III.I.3.h.(5) of this final rule, where
we discuss our proposals for scoring the Promoting Interoperability
performance category.
(2) Calculating the Final Score
For a description of the statutory basis and our policies for
calculating the final score for MIPS eligible clinicians, we refer
readers to Sec. 414.1380(c), the discussion in the CY 2017 Quality
Payment Program final rule (81 FR 77319 through 77329), and the
discussion in the CY 2018 Quality Payment Program final rule (82 FR
53769 through 53785). In this final rule, we discuss our proposal to
continue the complex patient bonus for the 2021 MIPS payment year, as
well as a

[[Page 59869]]

modification to the final score calculation for the 2021 MIPS payment
year. Finally, we discuss refinements to reweighting policies.
(a) Accounting for Risk Factors
Section 1848(q)(1)(G) of the Act requires us to consider risk
factors in our scoring methodology. Specifically, it provides that the
Secretary, on an ongoing basis, shall, as the Secretary determines
appropriate and based on individuals' health status and other risk
factors, assess appropriate adjustments to quality measures, cost
measures, and other measures used under MIPS and assess and implement
appropriate adjustments to payment adjustments, final scores, scores
for performance categories, or scores for measures or activities under
MIPS. In doing so, the Secretary is required to take into account the
relevant studies conducted under section 2(d) of the Improving Medicare
Post-Acute Care Transformation Act of 2014 (IMPACT Act) and, as
appropriate, other information, including information collected before
completion of such studies and recommendations.
(i) Considerations for Social Risk
In the CY 2019 PFS proposed rule (83 FR 35964), we summarized our
efforts related to social risk and the relevant studies conducted under
section 2(d) of the IMPACT Act. We received several comments suggesting
various approaches to adjust for social risk factors in the Quality
Payment Program going forward. We thank commenters for their input and
will take this input into consideration in future years. We also plan
to continue working with ASPE, the public, and other key stakeholders
on this important issue to identify policy solutions that achieve the
goals of attaining health equity for all beneficiaries and minimizing
unintended consequences.
(ii) Complex Patient Bonus for the 2021 MIPS Payment Year
In the CY 2018 Quality Payment Program final rule, under the
authority in section 1848(q)(1)(G) of the Act, we finalized at Sec.
414.1380(c)(3) a complex patient bonus of up to 5 points to be added to
the final score for the 2020 MIPS payment year (82 FR 53771 through
53776). We intended for this bonus to serve as a short-term strategy to
address the impact patient complexity may have on MIPS scoring while we
continue to work with stakeholders on methods to account for patient
risk factors. Our overall goal for the complex patient bonus was two-
fold: (1) To protect access to care for complex patients and provide
them with excellent care; and (2) to avoid placing MIPS eligible
clinicians who care for complex patients at a potential disadvantage
while we review the completed studies and research to address the
underlying issues. We noted that we would assess on an annual basis
whether to continue the bonus and how the bonus should be structured
(82 FR 53771). For a detailed description of the complex patient bonus
finalized for the 2020 MIPS payment year, please refer to the CY 2018
Quality Payment Program final rule (82 FR 53771 through 53776).
For the 2019 MIPS performance period/2021 MIPS payment year, we
proposed in the CY 2019 PFS proposed rule to continue the complex
patient bonus as finalized for the 2018 MIPS performance period/2020
MIPS payment year and to revise Sec. 414.1380(c)(3) to reflect this
policy (83 FR 35964 through 35965). Although we intended to maintain
the complex patient bonus as a short-term solution, we did not believe
we had sufficient information available at the time of the proposed
rule to develop a long-term solution to account for patient risk
factors in MIPS such that we would be able to propose a different
approach for the 2019 MIPS performance period/2021 MIPS payment year.
At the time of the proposed rule, we did not believe additional data
sources were available that would be feasible to use as the basis for a
different approach to account for patient risk factors in MIPS. In the
CY 2019 PFS proposed rule, we noted our intention to analyze data when
feasible from the 2017 MIPS performance period to identify differences
in performance that are consistent across performance categories and
that we may, in the future, shift the complex patient bonus to specific
performance categories (83 FR 35965). In the absence of data analysis
from the first year of MIPS, we did not believe that a change was
appropriate at that time. Therefore, we stated that while we work with
stakeholders to identify a long-term approach to account for patient
risk factors in MIPS, we believed it was appropriate to continue the
complex patient bonus for another year to support MIPS eligible
clinicians who treat patients with risk factors, as well as to maintain
consistency with the 2020 MIPS payment year and minimize confusion. We
had received significant feedback from MIPS eligible clinicians that
consistency in the MIPS program over time is valued when possible in
order to minimize confusion and to help MIPS eligible clinicians
predict how they will be scored under MIPS. Therefore, we stated our
belief that it is appropriate to maintain consistent policies for the
complex patient bonus in the 2021 MIPS payment year until we have
sufficient evidence and new data sources that support an updated
approach to account for patient risk factors.
Although we did not propose changes to the complex patient bonus
for the 2021 MIPS payment year, we stated that the dates used in the
calculation of the complex patient bonus may change as a result of
other proposals we made in the CY 2019 PFS proposed rule (83 FR 35885
through 35886). For the 2020 MIPS payment year, we finalized that we
will use the second 12-month segment of the eligibility determination
period to calculate average HCC risk scores and the proportion of full
benefit or partial benefit dual eligible beneficiaries for MIPS
eligible clinicians (82 FR 53771 through 53772). We proposed to change
the dates of the eligibility determination period (now referred to as
the MIPS determination period) beginning with the 2021 MIPS payment
year (83 FR 35885 through 35886). Specifically, the second 12-month
segment would begin on October 1 of the calendar year preceding the
applicable performance period and end on September 30 of the calendar
year in which the applicable performance period occurs. We indicated
that if this proposed change to the MIPS determination period is
finalized, then beginning with the 2021 MIPS payment year, the second
12-month segment of the MIPS determination period (beginning on October
1 of the calendar year preceding the applicable performance period and
ending on September 30 of the calendar year in which the applicable
performance period occurs) would be used when calculating average HCC
risk scores and proportion of full benefit or partial benefit dual
eligible beneficiaries for MIPS eligible clinicians.
We solicited comments on the above proposals. These comments and
our responses are discussed below.
Comment: Several commenters supported our proposal to continue the
complex patient bonus for the 2019 MIPS performance period/2021 MIPS
payment year. Commenters stated that the bonus helps to create fairer
scoring for MIPS eligible clinicians. Some commenters requested that we
continue the bonus beyond the 2019 MIPS performance period/2021 MIPS
payment year. A few commenters supported the complex patient bonus but
requested that we increase the complex patient bonus above the proposed
5 points, stating that 5 points

[[Page 59870]]

will have a minimal impact on the final score.
Response: We thank commenters for their support of our proposal to
maintain the complex patient bonus for the 2019 MIPS performance
period/2021 MIPS payment year. We plan to review available information,
including any updated data, in future years to determine if it is
appropriate to modify our approach to adjusting for social risk
factors. As we stated in the CY 2018 Quality Payment Program final rule
(82 FR 53775), we believe a complex patient bonus of 5 points added to
the final score is appropriate and is justified by information
currently available at this time.
Comment: Several commenters did not support our approach for the
complex patient bonus. Commenters pointed out limitations in the use of
HCC and dual-eligibility to calculate the complex patient bonus. For
instance, commenters stated that these indicators are not sufficient to
adjust for differences in performance and suggested other indicators
that might be more appropriate (such as income or education).
Commenters urged us to continue to explore alternative methods to
adjust for patient complexity in future years.
Response: We understand that both HCC risk scores and dual
eligibility have some limitations as proxies for social risk factors.
However, we are not aware of data sources for indicators such as income
and education that are readily available for all Medicare beneficiaries
that would be more complete indices of a patient's complexity. We have
decided to pair the HCC risk score with the proportion of dual eligible
patients to create a more complete complex patient indicator than can
be captured using HCC risk scores alone. We will evaluate additional
options in future years based on any updated data or additional
information in order to better account for social risk factors while
minimizing unintended consequences.
Comment: One commenter recommended that we use the 12-month
performance period to determine the complex patient bonus, stating that
it is the most accurate representation of the patient population of a
MIPS eligible clinician.
Response: We believe that aligning the time period for assigning
beneficiaries for purposes of calculating the complex patient bonus
with the MIPS determination period is preferable for simplicity. In
addition, when we designed our systems, we incorporated user feedback
that requested eligibility information be connected to data submission.
In order to be able to provide this information on the complex patient
bonus at or near the time of data submission, it is necessary to use
the second 12-month segment of the MIPS determination period as
proposed to identify beneficiaries for purposes of assigning HCC risk
scores and full benefit or partial benefit dual eligible beneficiaries
to MIPS eligible clinicians, rather than the performance period. We
note that this second 12-month segment begins 3 months before the year
in which the performance period occurs and ends 9 months into the year
in which the performance period occurs, creating a considerable overlap
between the MIPS determination period and the year in which the
performance period occurs (9 months).
After consideration of public comments, we are finalizing our
proposal to continue the complex patient bonus for the 2019 MIPS
performance period/2021 MIPS payment year as proposed. We are also
finalizing the changes to the regulation text at Sec. 414.1380(c)(3)
as proposed. We are also modifying the timing used to calculate the
complex patient bonus based on our changes to the MIPS determination
period finalized in III.I.3.b. of this final rule. The second 12-month
segment of the MIPS determination period will be used when calculating
average HCC risk scores and the proportion of full benefit or partial
benefit dual eligible beneficiaries for MIPS eligible clinicians.
(b) Final Score Performance Category Weights
(i) General Weights
Section 1848(q)(5)(E)(i) of the Act specifies weights for the
performance categories included in the MIPS final score: In general, 30
percent for the quality performance category; 30 percent for the cost
performance category; 25 percent for the Promoting Interoperability
(formerly advancing care information) performance category; and 15
percent for the improvement activities performance category. For more
of the statutory background and descriptions of our current policies,
we refer readers to the CY 2017 and CY 2018 Quality Payment Program
final rules (81 FR 77320 and 82 FR 53779, respectively). Under the
proposals we are finalizing in sections III.I.3.h.(3)(a) and
III.I.3.h.(2)(a)(ii) of this final rule, for the 2021 MIPS payment
year, the cost performance category will make up 15 percent and the
quality performance category will make up 45 percent of a MIPS eligible
clinician's final score. Table 53 summarizes the weights specified for
each performance category.

Table 53--Finalized Weights by MIPS Performance Category and MIPS Payment Year
----------------------------------------------------------------------------------------------------------------
2019 MIPS 2020 MIPS
payment year payment year 2021 MIPS
Performance category (previously (previously payment year
finalized) finalized) (finalized)
(percent) (percent) (percent)
----------------------------------------------------------------------------------------------------------------
Quality......................................................... 60 50 45
Cost............................................................ 0 10 15
Improvement Activities.......................................... 15 15 15
Promoting Interoperability...................................... 25 25 25
----------------------------------------------------------------------------------------------------------------

(ii) Flexibility for Weighting Performance Categories
Under section 1848(q)(5)(F) of the Act, if there are not sufficient
measures and activities applicable and available to each type of MIPS
eligible clinician involved, the Secretary shall assign different
scoring weights (including a weight of zero) for each performance
category based on the extent to which the category is applicable to the
type of MIPS eligible clinician involved and for each measure and
activity with respect to each performance category based on the extent
to which the measure or activity is applicable and available to the
type of MIPS eligible clinician involved. Under section
1848(q)(5)(B)(i) of the Act, in the case of a MIPS eligible clinician
who fails to report on an applicable measure or activity that is
required to be reported by the clinician, the clinician must be treated
as

[[Page 59871]]

achieving the lowest potential score applicable to such measure or
activity. In this scenario of failing to report, the MIPS eligible
clinician would receive a score of zero for the measure or activity,
which would contribute to the final score for that MIPS eligible
clinician. Assigning a scoring weight of zero percent and
redistributing the weight to the other performance categories differs
from the scenario of a MIPS eligible clinician failing to report on an
applicable measure or activity that is required to be reported.
(A) Scenarios Where the Quality, Cost, Improvement Activities, and
Promoting Interoperability Performance Categories Would Be Reweighted
In the CY 2017 and CY 2018 Quality Payment Program final rules (81
FR 77322 through 77325 and 82 FR 53779 through 53780, respectively), we
explained our interpretation of what it means for there to be
sufficient measures applicable and available for the quality and cost
performance categories, and we finalized policies for the 2019 and 2020
MIPS payment years under which we would assign a scoring weight of zero
percent to the quality or cost performance category and redistribute
its weight to the other performance categories in the event there are
not sufficient measures applicable and available, as authorized by
section 1848(q)(5)(F) of the Act. For the quality performance category,
we stated that having sufficient measures applicable and available
means that we can calculate a quality performance category percent
score for the MIPS eligible clinician because at least one quality
measure is applicable and available to the clinician (82 FR 53780). For
the cost performance category, we stated that having sufficient
measures applicable and available means that we can reliably calculate
a score for the cost measures that adequately captures and reflects the
performance of a MIPS eligible clinician (82 FR 53780). We established
that if a MIPS eligible clinician is not attributed enough cases for a
cost measure (in other words, has not met the required case minimum for
the measure), or if a cost measure does not have a benchmark, then the
measure will not be scored for that clinician (81 FR 77323). We stated
that if we do not score any cost measures for a MIPS eligible clinician
in accordance with this policy, then the clinician would not receive a
cost performance category percent score (82 FR 53780).
In the CY 2019 PFS proposed rule, we proposed to codify these
policies for the quality and cost performance categories at Sec.
414.1380(c)(2)(i)(A)(1) and (2), respectively, and to continue them for
the 2021 MIPS payment year and each subsequent MIPS payment year (83 FR
35966).
For the Promoting Interoperability performance category, in the CY
2017 Quality Payment Program final rule (81 FR 77238 through 77245) and
the CY 2018 Quality Payment Program final rule (82 FR 53680 through
53687), we established policies for assigning a scoring weight of zero
percent to the Promoting Interoperability performance category and
redistributing its weight to the other performance categories in the
final score. We proposed to codify those policies under Sec.
414.1380(c)(2)(i) and (iii) (83 FR 35966).
For the improvement activities performance category, we stated in
the CY 2019 proposed rule (83 FR 35967 through 35968) that we continue
to believe that all MIPS eligible clinicians will have sufficient
activities applicable and available, except for limited extreme and
uncontrollable circumstances, such as natural disasters, where a
clinician is unable to report improvement activities, and circumstances
where a MIPS eligible clinician joins a practice in the final 3 months
of the performance period as discussed in the CY 2019 PFS proposed rule
(83 FR 35967 through 35968). We stated that, barring these
circumstances, we believe that all MIPS eligible clinicians will have
sufficient improvement activities applicable and available (82 FR
53780).
We solicited comments on the above proposals. These comments and
our responses are discussed below.
Comment: One commenter supported our reweighting policies, stating
that they provide flexibility for MIPS eligible clinicians who are
unable to participate in specific performance categories.
Response: We thank this commenter for its support.
Comment: One commenter expressed concern with our reweighting
policies, because the commenter believes MIPS eligible clinician may
expend resources to submit data to us, and then receive reweighting
based on our determination that there are not sufficient measures or
activities applicable and available.
Response: Our reweighting policies would not lead us to reweight a
MIPS eligible clinician after they submit data for a given performance
category. Rather, we would consider whether these policies are
applicable in the event that we do not receive any data for a MIPS
eligible clinician for a particular performance category. If we
determine that the clinician is eligible for reweighting under our
policies, then we would redistribute the weight of the performance
category, rather than awarding a score of zero to the clinician for
that performance category.
After consideration of public comments, we are finalizing our
proposal to codify the reweighting policies for the quality and cost
performance categories at Sec. 414.1380(c)(2)(i)(A)(1) and (2),
respectively, and to continue them for the 2021 MIPS payment year and
each subsequent MIPS payment year, as proposed. We are also finalizing
our proposal to codify the Promoting Interoperability reweighting
policies under Sec. 414.1380(c)(2)(i) and (iii) as proposed.
(B) Reweighting the Quality, Cost, and Improvement Activities
Performance Categories for Extreme and Uncontrollable Circumstances
For a summary of the final policy we adopted beginning with the
2018 MIPS performance period/2020 MIPS payment year to reweight the
quality, cost, and improvement activities performance categories based
on a request submitted by a MIPS eligible clinician, group, or virtual
group that was subject to extreme and uncontrollable circumstances, we
refer readers to the CY 2018 Quality Payment Program final rule (82 FR
53780 through 53783). In the proposed rule (83 FR 35966), we proposed
to codify this policy at Sec. 414.1380(c)(2)(i)(A)(5), but we
inadvertently referred to the wrong paragraph of the regulation text,
and the citation should have read Sec. 414.1380(c)(2)(i)(A)(6).
We proposed a few minor modifications to our extreme and
uncontrollable circumstances policy (83 FR 35967). First, beginning
with the 2019 MIPS performance period/2021 MIPS payment year, we
proposed at Sec. 414.1380(c)(2)(i)(A)(5) (which should have read Sec.
414.1380(c)(2)(i)(A)(6)) that, if a MIPS eligible clinician submits an
application for reweighting based on extreme and uncontrollable
circumstances, but also submits data on the measures or activities
specified for the quality or improvement activities performance
categories in accordance with Sec. 414.1325, he or she would be scored
on the submitted data like all other MIPS eligible clinicians, and the
categories would not be reweighted (83 FR 35967). We proposed this
modification to align with a similar policy for the Promoting
Interoperability performance category (82 FR 53680 through 53682). We
stated that if a MIPS eligible clinician reports on measures or
activities specified for the quality or improvement activities
performance categories, then we assume the clinician

[[Page 59872]]

believes there are sufficient measures or activities applicable and
available to the clinician.
For most quality measures and improvement activities, the data
submission occurs after the end of the MIPS performance period, so
clinicians would know about the extreme and uncontrollable circumstance
prior to submission. However, for the quality performance category,
measures submitted via the Medicare Part B claims collection type are
submitted by adding quality data codes to a claim. As a result, it is
possible that a MIPS eligible clinician could have submitted some
Medicare Part B claims collection type data prior to the submission of
a reweighting application for extreme and uncontrollable events. Under
our proposal, we would score the quality performance category because
we have received data. However, we previously finalized at Sec.
414.1380(c) that if a MIPS eligible clinician is scored on fewer than
two performance categories, he or she will receive a final score equal
to the performance threshold (81 FR 77320 through 77321 and 82 FR 53778
through 53779). If a clinician experiences an extreme and
uncontrollable event that affects all of the performance categories,
then under our proposal, the clinician would only be scored on the
quality performance category if they submit data for only that
category. The clinician would also have to submit data for the
improvement activities or the Promoting Interoperability performance
categories in order to be scored on two or more performance categories
and receive a final score different than the performance threshold.
This proposal did not include administrative claims data that we
receive through the claims submission process and use to calculate the
cost measures and certain quality measures. As finalized in the CY 2017
Quality Payment Program final rule (81 FR 77094 through 77095), and as
we are codifying in this final rule at Sec. 414.1325(a)(2), there are
no data submission requirements for the cost performance category and
for certain quality measures used to assess performance in the quality
performance category. Please see section III.I.3.h.(1)(b) of this final
rule for a description of collection types, submission types, and
submitter types. We calculate performance on these measures using
administrative claims data, and clinicians are not required to submit
any additional data for these measures. Therefore, we stated that we
did not believe that it would be appropriate to void a reweighting
application based on administrative claims data we receive for measures
that do not require data submission for purposes of MIPS.
We also proposed to apply the policy we finalized for virtual
groups in the CY 2018 Quality Payment Program final rule (82 FR 53782
through 53783) to groups submitting reweighting applications for the
quality, cost, or improvement activities performance categories based
on extreme and uncontrollable circumstances (83 FR 35967). For groups,
we would evaluate whether sufficient measures and activities are
applicable and available to MIPS eligible clinicians in the group on a
case-by-case basis and determine whether to reweight a performance
category based on the information provided for the individual
clinicians and practice location(s) affected by extreme and
uncontrollable circumstances and the nature of those circumstances. In
the CY 2019 PFS proposed rule (83 FR 35967), we stated that although we
did not specifically propose to apply this policy to groups in the CY
2018 Quality Payment Program proposed rule, our intention was to apply
the same policy for groups and virtual groups, and thus if we adopt
this proposal, we would apply the policy to groups beginning with the
2018 performance period/2020 MIPS payment year.
We solicited comments on the above proposals. These comments and
our responses are discussed below.
Comment: One commenter supported our proposal for groups, stating
that all MIPS eligible clinicians in the group will likely be facing
the same barriers and a group application will reduce administrative
burden and redundancy.
Response: We thank the commenter for its support of our proposal to
apply the same policy we established for virtual groups to groups.
Under the proposed policy, we would evaluate whether sufficient
measures and activities are applicable and available to MIPS eligible
clinicians in the group on a case-by-case basis and determine whether
to reweight a performance category based on the information provided
for the individual clinicians and practice location(s) affected by
extreme and uncontrollable circumstances and the nature of those
circumstances.
Comment: One commenter expressed concern that MIPS eligible
clinicians who submit an application for reweighting based on extreme
and uncontrollable circumstances, but who also report via Medicare Part
B claims collection type may be unfairly penalized if claims data is
received prior to the extreme and uncontrollable event. Another
commenter suggested that we should score data received from MIPS
eligible clinicians who submit a reweighting application only if they
would receive a score that would result in a payment adjustment no
lower than a neutral adjustment.
Response: If a MIPS eligible clinician reports via Medicare Part B
claims collection type for the quality performance category, and we
receive an application for reweighting for the clinician based on
extreme and uncontrollable circumstances, their Medicare Part B claims
data would only contribute to their final score if they also submit
data for either the Promoting Interoperability or the improvement
activities performance categories. We previously finalized at Sec.
414.1380(c) that if a MIPS eligible clinician is scored on fewer than
two performance categories, he or she will receive a final score equal
to the performance threshold (81 FR 77320 through 77321 and 82 FR 53778
through 53779). The clinician's cost performance category score would
not contribute to their final score because as we discuss above, there
are no data submission requirements for the cost performance category,
and we do not believe that it would be appropriate to void a
reweighting application based on administrative claims data we receive
for measures that do not require data submission for purposes of MIPS.
We assume that if a MIPS eligible clinician submits data to us
following the submission of an application for reweighting based on
extreme and uncontrollable circumstances, the clinician believes there
are sufficient measures or activities applicable and available to them
and would like their data to contribute to their final score. However,
once the data is submitted, it will be scored based on performance in
accordance with our policies, and the clinician could receive a
negative payment adjustment.
After consideration of public comments, we are finalizing our
proposal to codify the final policy we adopted beginning with the 2018
MIPS performance period/2020 MIPS payment year to reweight the quality,
cost, and improvement activities performance categories based on a
request submitted by a MIPS eligible clinician, group, or virtual group
that was subject to extreme and uncontrollable circumstances. We are
finalizing our proposal that, beginning with the 2019 performance
period/2021 MIPS payment year, if a MIPS eligible clinician submits an
application for reweighting based on extreme and uncontrollable
circumstances, but also

[[Page 59873]]

submits data on the measures or activities specified for the quality or
improvement activities performance categories in accordance with Sec.
414.1325, he or she will be scored on the submitted data like all other
MIPS eligible clinicians, and the categories will not be reweighted. We
are also finalizing our proposal, beginning with the 2018 performance
period/2020 MIPS payment year, that, for groups, we will evaluate
whether sufficient measures and activities are applicable and available
to MIPS eligible clinicians in the group on a case-by-case basis and
determine whether to reweight a performance category based on the
information provided. We are finalizing the regulation text at Sec.
414.1380(c)(2)(i)(A)(6) as proposed.
(C) Reweighting the Quality, Cost, Improvement Activities, and
Promoting Interoperability Performance Categories for MIPS Eligible
Clinicians Who Join a Practice in the Final 3 Months of the Performance
Period Year
Beginning with the 2019 MIPS performance period, we proposed that a
MIPS eligible clinician who joins an existing practice (existing TIN)
during the final 3 months of the calendar year in which the MIPS
performance period occurs (the performance period year) that is not
participating in MIPS as a group would not have sufficient measures
applicable and available (83 FR 35967 through 35968). We also proposed
that a MIPS eligible clinician who joins a practice that is newly
formed (new TIN) during the final 3 months of the performance period
year would not have sufficient measures applicable and available,
regardless of whether the clinicians in the practice report for
purposes of MIPS as individuals or as a group (83 FR 35967 through
35968). In each of these scenarios, we proposed to reweight all four of
the performance categories to zero percent for the MIPS eligible
clinician and, because he or she would be scored on fewer than two
performance categories, the MIPS eligible clinician would receive a
final score equal to the performance threshold and a neutral MIPS
payment adjustment under the policy at Sec. 414.1380(c) (83 FR 35967
through 35968). We proposed to codify these policies at Sec.
414.1380(c)(2)(i)(A)(3).
We proposed this policy because we are not currently able to
identify these MIPS eligible clinicians (or groups if the group is
formed in the final 3 months of the performance period year) at the
start of the MIPS submission period. When we designed our systems, we
incorporated user feedback that requested eligibility information be
connected to the submission process. In order to submit data, an
individual TIN/NPI or the group TIN must be in the files generated from
the MIPS eligibility determination periods. As discussed in the CY 2019
PFS proposed rule (83 FR 35885 through 35886), we have two 12-month
determination periods for eligibility. We proposed and are finalizing
in section III.II.3.b. of this final rule that the second 12-month
segment of the MIPS eligibility determination period will end on
September 30 of the calendar year in which the applicable MIPS
performance period occurs; therefore, we will have no eligibility
information about clinicians who join a practice after September 30 of
the performance period year. MIPS eligible clinicians who join an
existing practice (existing TIN) in the final 3 months of the
performance period year that is not participating in MIPS as a group
will not be identified by our systems, and we will not have the ability
to inform them that they are eligible or to receive MIPS data from
them. Similarly, practices that form (new TIN) in the final 3 months of
the performance period year will not be in the MIPS determination
files. Accordingly, we stated that the measures and activities would
not be available because any data from these MIPS eligible clinicians
would not be accessible to us.
If a MIPS eligible clinician joins a practice (existing TIN) in the
final 3 months of the performance period year, and the practice is not
newly formed and is reporting as a group for the performance period,
the MIPS eligible clinician will be able to report as part of that
group. In this case, we are able to accept data for the group because
the TIN would be in our MIPS eligibility determination files.
Therefore, we stated that we believe the measures and activities would
be available in this scenario, and reweighting would not be necessary
for the MIPS eligible clinician. We noted that, if a MIPS eligible
clinician's TIN/NPI combination was not part of the group practice
during the MIPS determination period, the TIN/NPI combination will not
be identified in our system at the start of the MIPS data submission
period; however, if the MIPS eligible clinician qualifies to receive
the group final score under our proposal, we would apply the group
final score to the MIPS eligible clinician's TIN/NPI combination as
soon as the information becomes available. Please see section
III.I.3.j.(1) of this final rule for more information about assigning
group scores to MIPS eligible clinicians.
We solicited comments on the above proposals. These comments and
our responses are discussed below.
Comment: Several commenters supported our proposal to reweight MIPS
eligible clinicians who form a new practice in the final 3 months of
the performance period year or join an existing practice that does not
participate in MIPS as a group.
Response: We thank commenters for their support of our proposal.
Comment: One commenter requested that we extend this policy to the
2018 performance period as well.
Response: We note that we did not propose to apply the policy to
the 2018 performance period, and as such, we will not be extending it
in this final rule.
Comment: One commenter did not support our proposal to treat MIPS
eligible clinicians who join a new or existing practice in the final 3
months of the performance period year differently depending on whether
the practice reports as a group. The commenter also requested that we
reweight MIPS eligible clinicians who switch practices at any time
during the performance period, because a MIPS eligible clinician's
previous practice may not report on their behalf and because clinicians
are impacted by training and other requirements associated with
switching practices that may impact performance.
Response: A MIPS eligible clinician who joins an existing practice
that is participating in MIPS as a group would have the opportunity to
contribute to the group's performance and final score. We refer readers
to section III.I.3.j.(1) of this final rule for a discussion of which
MIPS eligible clinicians may receive a group final score. We do not
believe it would be appropriate to reweight the performance categories
for MIPS eligible clinicians who change practices at any time during
the performance period year because, consistent with our discussion in
the CY 2019 PFS proposed rule (83 FR 35967 through 35968), we would be
able to identify these clinicians at the beginning of the MIPS
submission period if they change practices prior to the final 3 months
of the performance period year. We also believe MIPS eligible
clinicians who change practices prior to the final 3 months of the
performance period year generally should have sufficient time to
prepare for MIPS reporting, in the event that their prior practice does
not submit data for them.
After consideration of public comments, we are finalizing as

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proposed our proposal to reweight the quality, cost, improvement
activities, and Promoting Interoperability performance categories to
zero percent for MIPS eligible clinicians who join an existing practice
(existing TIN) during the final 3 months of the performance period year
that is not participating in MIPS as a group, or a practice that is
newly formed (new TIN) during the final 3 months of the performance
period year regardless of whether the clinicians in the practice report
for purposes of MIPS as individuals or as a group. We are finalizing
the proposed regulation text at Sec. 414.1380(c)(2)(i)(A)(3) as
proposed.
(D) Automatic Extreme and Uncontrollable Circumstances Policy Beginning
With the 2020 MIPS Payment Year
In conjunction with the CY 2018 Quality Payment Program final rule,
and due to the impact of Hurricanes Harvey, Irma, and Maria, we issued
an interim final rule with comment period (IFC) in which we adopted on
an interim final basis a policy for automatically reweighting the
quality, improvement activities, and advancing care information (now
referred to as Promoting Interoperability) performance categories for
the transition year of MIPS (the 2017 performance period/2019 MIPS
payment year) for MIPS eligible clinicians who are affected by extreme
and uncontrollable circumstances affecting entire regions or locales
(82 FR 53895 through 53900).
In the CY 2019 PFS proposed rule (83 FR 35968), we stated that we
believe that a similar automatic extreme and uncontrollable
circumstances policy would be appropriate for any year of the MIPS
program to account for natural disasters and other extreme and
uncontrollable circumstances that impact an entire region or locale. As
we discussed in the interim final rule (82 FR 53897), we believe such a
policy would reduce burden on clinicians who have been affected by
widespread catastrophes and would align with existing policies for
other Medicare programs. We proposed at Sec. 414.1380(c)(2)(i)(A)(7)
and (c)(2)(i)(C)(3) to apply the automatic extreme and uncontrollable
circumstances policy we adopted for the transition year to subsequent
years of the MIPS program, beginning with the 2018 MIPS performance
period and the 2020 MIPS payment year, with a few additions to address
the cost performance category (83 FR 35968). We note that we
inadvertently referred to the wrong paragraph of the regulation text in
the proposed rule, and the citation should have read Sec.
414.1380(c)(2)(i)(A)(8) instead of Sec. 414.1380(c)(2)(i)(A)(7). For a
description of the policy we adopted for the MIPS transition year, we
refer readers to the discussion in the interim final rule (82 FR 53895
through 53900).
In the interim final rule (82 FR 53897), we stated that we were not
including the cost performance category in the automatic extreme and
uncontrollable circumstances policy for the transition year because the
cost performance category is weighted at zero percent in the final
score for the 2017 MIPS performance period/2019 MIPS payment year. We
finalized a 10 percent weight for the cost performance category for the
2018 MIPS performance period/2020 MIPS payment year (82 FR 53643) and
are finalizing a 15 percent weight for the 2019 performance period/2021
MIPS payment year (see section III.I.3.h.(3)(a) of this final rule). In
the CY 2019 PFS proposed rule (83 FR 35968), we stated that for the
reasons discussed in the CY 2018 Quality Payment Program final rule (82
FR 53781), we believe a MIPS eligible clinician's performance on
measures calculated based on administrative claims data, such as the
measures specified for the cost performance category, could be
adversely affected by a natural disaster or other extreme and
uncontrollable circumstance, and that the cost measures may not be
applicable to that MIPS eligible clinician. Therefore, we proposed to
include the cost performance category in the automatic extreme and
uncontrollable circumstances policy beginning with the 2018 MIPS
performance period/2020 MIPS payment year (83 FR 35968). Under our
policy for the transition year, if a MIPS eligible clinician in an
affected area submits data for any of the MIPS performance categories
by the applicable submission deadline for the 2017 MIPS performance
period, he or she will be scored on each performance category for which
he or she submits data, and the performance category will not be
reweighted to zero percent in the final score (82 FR 53898). Our policy
for the transition year did not include measures that are calculated
based on administrative claims data (82 FR 53898). As finalized in the
CY 2017 Quality Payment Program final rule (81 FR 77094 through 77095),
and as we are codifying in this final rule at Sec. 414.1325(a)(2),
there are no data submission requirements for the cost performance
category, and we will calculate performance on the measures specified
for the cost performance category using administrative claims data. We
proposed for the cost performance category, if a MIPS eligible
clinician is located in an affected area, we would assume the clinician
does not have sufficient cost measures applicable to him or her and
assign a weight of zero percent to that category in the final score,
even if we receive administrative claims data that would enable us to
calculate the cost measures for that clinician (83 FR 35968).
In the interim final rule (82 FR 53897), we did not include an
automatic extreme and uncontrollable circumstances policy for groups or
virtual groups, and we stated in the CY 2019 PFS proposed rule (83 FR
35968) that we continue to believe such a policy is not necessary.
Unless we receive data from a TIN indicating that the TIN would like to
be scored as a group for MIPS, performance by default is assessed at
the individual MIPS eligible clinician level. Similarly, performance is
not assessed at the virtual group level unless the member TINs submit
an application in accordance with Sec. 414.1315. We stated that if we
receive data from a group or virtual group, we would score that data,
even if individual MIPS eligible clinicians within the group or virtual
group are impacted by an event that would be included in our automatic
extreme and uncontrollable circumstances policy. Regardless of whether
we receive data from a group or virtual group, we would have no
mechanism to determine whether the group or virtual group did not
submit data, or submitted data and performed poorly, because it had
been affected by an extreme and uncontrollable event unless the group
notifies us of its circumstances. Instead of establishing a threshold
for groups or virtual groups to receive automatic reweighting based on
the number of clinicians in the group or virtual group impacted by
extreme and uncontrollable events, we stated that we believe it is
preferable that these groups and virtual groups submit an application
for reweighting based on extreme and uncontrollable circumstances under
our existing policy (82 FR 53780 through 53783) where they may be
eligible for reweighting if they establish that the group or virtual
group was sufficiently impacted by the extreme and uncontrollable
event.
We solicited comments on the above proposals. These comments and
our responses are discussed below.
Comment: Several commenters supported our proposed application of
the automatic extreme and uncontrollable policy starting with the 2018
MIPS performance period/2020 MIPS payment year to reduce burden on

[[Page 59875]]

impacted MIPS eligible clinicians. A few commenters supported our
proposal to extend the automatic extreme and uncontrollable policy to
include the cost performance category for the 2018 MIPS performance
period/2020 MIPS payment year and future years.
Response: We thank commenters for their support of our proposals.
Comment: One commenter suggested that we only score performance
categories (including the cost performance category) for MIPS eligible
clinicians impacted by the automatic extreme and uncontrollable policy
if they would receive a positive or neutral payment adjustment.
Response: If a MIPS eligible clinician reports via Medicare Part B
claims collection type for the quality performance category, and we
receive data for the clinician prior to a triggering event for the
automatic extreme and uncontrollable circumstances policy, their
Medicare Part B claims data would only contribute to their final score
if they also submit data for either the Promoting Interoperability or
the improvement activities performance categories. We previously
finalized at Sec. 414.1380(c) that if a MIPS eligible clinician is
scored on fewer than two performance categories, he or she will receive
a final score equal to the performance threshold (81 FR 77320 through
77321 and 82 FR 53778 through 53779). We assume that if a MIPS eligible
clinician submits data to us following a triggering event, the
clinician believes there are sufficient measures or activities
applicable and available to them and would like their data to
contribute to their final score. However, once the data is submitted,
it will be scored based on performance in accordance with our policies,
and the clinician could receive a negative payment adjustment.
Comment: One commenter disagreed with our decision to not propose
an automatic extreme and uncontrollable circumstances policy for
groups, because clinicians who choose to report as group for purposes
of MIPS conduct all aspects of MIPS at a group level.
Response: We continue to believe that a group policy is not
necessary and that there are barriers to implementing such a policy.
For example, because group reporting is optional, we would have no
mechanism to determine who would have been intending to report without
receiving a data submission. Additionally, some groups may be split
between areas that are impacted by the triggering event and areas that
are not. We do not believe that it would be appropriate to make a
decision about how the group is impacted without additional
information. We believe our application-based extreme and
uncontrollable circumstances policy provides the mechanism for such an
assessment. Finally, we note that if all the MIPS eligible clinicians
in a group are located in an area affected by the extreme and
uncontrollable circumstance, and the group is not able to submit for
MIPS as a group, then all the MIPS eligible clinicians in the group
would be considered as individuals and covered by the automatic extreme
and uncontrollable circumstances policy.
After consideration of public comments received, we are finalizing
these proposals and the regulation text at Sec.
414.1380(c)(2)(i)(A)(8) and (c)(2)(i)(C)(3) as proposed.
iii. Extreme and Uncontrollable Circumstance Policy for the 2017
Performance Period/2019 MIPS Payment Year
As discussed in the preceding section III.I.3.i.(2)(b)(ii)(D), in
conjunction with the CY 2018 Quality Payment Program final rule, and
due to the impact of Hurricanes Harvey, Irma, and Maria, we issued an
interim final rule with comment period (IFC) in which we adopted on an
interim final basis a policy for automatically reweighting the quality,
improvement activities, and advancing care information (now referred to
as Promoting Interoperability) performance categories for the
transition year of MIPS (the 2017 performance period/2019 MIPS payment
year) for MIPS eligible clinicians who are affected by extreme and
uncontrollable circumstances affecting entire regions or locales (82 FR
53895 through 53900). In the CY 2019 PFS proposed rule (83 FR 35968),
we proposed to codify this policy for the quality and improvement
activities performance categories at Sec. 414.1380(c)(2)(i)(A)(6) and
for the advancing care information (now Promoting Interoperability)
performance category at Sec. 414.1380(c)(2)(i)(C)(3). We note that we
inadvertently referred to the wrong paragraph of the regulation text in
the proposed rule, and the citation should have read Sec.
414.1380(c)(2)(i)(A)(7) instead of Sec. 414.1380(c)(2)(i)(A)(6).
A summary of the comments we received on the IFC and our responses
are included below.
Comment: Many commenters supported the automatic extreme and
uncontrollable circumstance policy for the 2017 MIPS performance
period. Several commenters stated that the policy is appropriate given
the burden these events have had on impacted MIPS eligible clinicians.
Several commenters supported the flexibility afforded by this policy
and noted that the policy will allow impacted MIPS eligible clinicians
to focus on providing patient care during natural disasters without
having to focus on MIPS reporting. Several commenters supported our
policy to allow clinicians impacted by extreme and uncontrollable
events to report for MIPS if they choose because commenters believe
some MIPS eligible clinicians may be less impacted by natural disasters
and may have interest in reporting for MIPS. One commenter supported
including events that have been designated by FEMA in the automatic
extreme and uncontrollable circumstance policy. Another commenter
supported using the practice location listed in PECOS to determine
eligibility for the automatic extreme and uncontrollable policy.
Response: We believe that the automatic extreme and uncontrollable
circumstance policy is appropriate to provide relief to MIPS eligible
clinicians experiencing natural disasters and will help to ensure they
are able to focus on providing patient care. In the CY 2018 Quality
Payment Program final rule, we noted that we anticipate the types of
events that could trigger this policy would be events designated as
FEMA major disasters or a public health emergency declared by the
Secretary, although we will review each situation on a case-by-case
basis (82 FR 53897).
Comment: One commenter urged CMS to develop a clear communications
plan for alerting MIPS eligible clinicians that they are eligible for
the automatic extreme and uncontrollable circumstance policy.
Response: We agree that it will be important to effectively alert
MIPS eligible clinicians who we determine are covered by the automatic
extreme and uncontrollable circumstance policy. Similar to other CMS
programs, we communicated applicability information through routine
communication channels, including, but not limited to, issuing memos,
emails, and notices on the QPP website, qpp.cms.gov.
Comment: One commenter stated that providing MIPS eligible
clinicians who are impacted by extreme and uncontrollable events with a
final score that is equal to the performance threshold if they report
on only one performance category does not recognize their efforts for
that performance category. Instead, commenter stated CMS should score
the MIPS eligible clinician on that category.
Response: We continue to believe that the final score for MIPS
should be a composite score. Therefore, for MIPS

[[Page 59876]]

eligible clinicians who are subject to the automatic extreme and
uncontrollable circumstance policy, we will continue to apply our
general MIPS policy codified at Sec. 414.1380(c) that MIPS eligible
clinicians who are scored on fewer than 2 performance categories
receive a score equal to the performance threshold (82 FR 53958). MIPS
eligible clinicians who are located in an area affected by extreme and
uncontrollable circumstances who submit data for the quality
performance category would also have to submit data for the Promoting
Interoperability or improvement activities performance categories in
order for the data submitted to contribute to their final score.
Comment: One commenter stated that scoring data that are submitted
by impacted MIPS eligible clinicians is unfair because they are being
assessed against MIPS eligible clinicians who were not impacted by
natural disasters.
Response: Because the performance threshold is set very low (at 3
points) for the 2017 MIPS performance period, we believe that MIPS
eligible clinicians who are eligible for the automatic extreme and
uncontrollable circumstance policy but submit data will easily exceed
the performance threshold and thus will not be negatively impacted.
Furthermore, we assume that MIPS eligible clinicians who are located in
an area affected by extreme and uncontrollable circumstances but then
submit data for more than one performance category believe there are
sufficient measures or activities applicable and available to them and
would like their data to contribute to their final score.
Comment: One commenter suggested that CMS should not score Medicare
Part B claims measures that are submitted by MIPS eligible clinicians
impacted by extreme and uncontrollable events.
Response: If a MIPS eligible clinician reports via Medicare Part B
claims for the quality performance category and we receive data prior
to the extreme and uncontrollable event, their Medicare Part B claims
data would only contribute to their final score if they also submit
data for either the Promoting Interoperability or improvement
activities performance categories. We previously finalized at Sec.
414.1380(c) that if a MIPS eligible clinician is scored on fewer than
two performance categories, he or she will receive a final score equal
to the performance threshold (81 FR 77320 through 77321 and 82 FR 53778
through 53779).
Comment: One commenter suggested that CMS consider providing a
positive payment adjustment for MIPS eligible clinicians who are
eligible for the automatic extreme and uncontrollable circumstance
policy instead of providing a neutral payment adjustment because this
will help to incentivize MIPS eligible clinicians to return to affected
areas.
Response: It is unclear to us how a positive payment adjustment
would incentivize clinicians to return to affected areas, or how we
would go about verifying whether and why they have returned, since many
factors influence clinician choice in practice location.
After consideration of the public comments, we are adopting the IFC
as a final rule without any modifications. We are finalizing the
regulation text at Sec. 414.1380(c)(2)(i)(A)(7) and Sec.
414.1380(c)(2)(i)(C)(3) as proposed.
(iv) Redistributing Performance Category Weights
In the CY 2017 and CY 2018 Quality Payment Program final rules, we
established policies for redistributing the weights of performance
categories for the 2019 and 2020 MIPS payment years in the event that a
scoring weight different from the generally applicable weight is
assigned to a category or categories (81 FR 77325 through 77329; 82 FR
53783 through 53785, 53895 through 53900). We proposed to codify these
policies under Sec. 414.1380(c)(2)(ii) (83 FR 35969).
For the 2021 MIPS payment year, we proposed at Sec.
414.1380(c)(2)(ii)(B) to apply similar reweighting policies as
finalized for the 2020 MIPS payment year (83 FR 35969). We note that we
inadvertently referred to the wrong paragraph of the regulation text in
the proposed rule, and the citation should have read Sec.
414.1380(c)(2)(ii)(C) instead of Sec. 414.1380(c)(2)(ii)(B). In
general, we would redistribute the weight of a performance category or
categories to the quality performance category. We stated that
redistributing weight to the quality performance category is
appropriate because of the experience MIPS eligible clinicians have had
reporting on quality measures under other CMS programs. We proposed to
continue to redistribute the weight of the quality performance category
to the improvement activities and Promoting Interoperability
performance categories (83 FR 35969). However, for the 2021 MIPS
payment year, based on our proposal to weight the cost performance
category at 15 percent, we proposed to reweight the Promoting
Interoperability performance category to 45 percent and the improvement
activities performance category to 40 percent when the quality
performance category is weighted at zero percent (83 FR 35969). We
chose to weigh Promoting Interoperability higher in order to align with
goals of interoperability and for simplicity because we generally have
avoided assigning partial percentage points to performance category
weights. Reweighting scenarios under the proposal are presented in
Table 54.

[[Page 59877]]

[GRAPHIC] [TIFF OMITTED] TR23NO18.069

We stated that we have heard from stakeholders in previous years
that our reweighting policies place undue weight on the quality
performance category, and, although we continue to believe the policies
are appropriate, we solicited comment on alternative redistribution
policies in which we would also redistribute weight to the improvement
activities performance category (see Table 55). Under the alternative
redistribution policy we considered, we would redistribute the weight
of the Promoting Interoperability performance category to the quality
and improvement activities performance categories (83 FR 35969 through
35970). We would redistribute 15 percent of the Promoting
Interoperability performance category weight to the quality performance
category, and 10 percent to the improvement activities performance
category. We stated that redistributing more of the weight of the
Promoting Interoperability performance category to the quality
performance category is appropriate because MIPS eligible clinicians
have had more experience reporting on quality measures under other CMS
programs than reporting on improvement activities. We would
redistribute the cost performance category weight equally to the
quality and improvement activities performance categories (5 percent to
each) under this alternative policy.
[GRAPHIC] [TIFF OMITTED] TR23NO18.070

[[Page 59878]]

We solicited comments on the above proposals. These comments and
our responses are discussed below.
Comment: A few commenters supported our proposed reweighting
policies for the 2019 MIPS performance period/2021 MIPS payment year.
Response: We thank commenters for their support of our proposal.
Comment: Several commenters supported the alternative policy we
considered to reweight to both quality and improvement activities, and
stated our primary proposal which generally reweights to quality,
places undue weight on the quality performance category. Some
commenters stated that reweighting to the improvement activities
performance category is appropriate given the importance of practice
improvement. A few commenters stated that the quality performance
category is particularly challenging, and therefore, placing additional
weight on this performance category would not be fair to MIPS eligible
clinicians who receive reweighting for the cost or Promoting
Interoperability performance categories. A few commenters also
mentioned that our reweighting policies place undue burden on small and
rural practices who have particular difficulty performing well on the
quality performance category. A few commenters requested that we
redistribute all of the weight of the Promoting Interoperability or
cost performance categories to the improvement activities performance
category, in order to avoid placing undue focus on quality and due to
the importance of quality improvement.
Response: We continue to believe reweighting to the quality
performance category is appropriate as the quality performance category
is a critical component of value-based care, and therefore, we believe
performance on quality measures is important. While there is variation
in performance for the quality performance category, for the
improvement activities we are only assessing whether the MIPS eligible
clinician completed activities. We believe that reweighting to the
quality performance category will encourage MIPS eligible clinicians to
report on the quality performance category due to the higher category
weight (that is, a zero score for this performance category would have
more significant impact), particularly those clinicians who may have
only reported to the improvement activities performance category, and
will minimize complexity. We believe it is important to encourage MIPS
eligible clinicians to report on quality while the performance
threshold is still relatively low. In regards to the concern on small
and rural practice performance in the quality performance category, we
note that small practices that report quality measures can receive the
small practice bonus we are finalizing in section
III.I.3.i.(1)(b)(viii) of this final rule and we have not seen
differences in performance for rural practices. We plan to review
available approaches to reweighting in future years including impact on
small and rural practices and may revisit our policies to ensure they
are fair and not overly complex.
Comment: One commenter disagreed with our proposal to reweight the
quality performance category to the improvement activities and
Promoting Interoperability performance categories, because the
commenter noted concern with our discussion of available and applicable
measures for the quality performance category and reweighting this
category would place greater weight on other performance categories.
Another commenter noted that reweighting the quality performance
category may lead to MIPS eligible clinicians inaccurately receiving a
positive, neutral, or negative payment adjustment.
Response: We believe reweighting to the improvement activities and
Promoting Interoperability performance categories in the rare cases
when the quality performance category is reweighted is appropriate
because MIPS eligible clinicians have limited experience being scored
on the cost performance category. We also expect the cases when a MIPS
eligible clinician does not have any quality measures to be very rare.
After consideration of public comments, we are finalizing these
proposals and the regulation text at Sec. 414.1380(c)(2)(ii)(A)
through (C) as proposed.
Because the cost performance category was zero percent of a MIPS
eligible clinician's final score for the 2017 MIPS performance period,
we stated in the CY 2019 PFS proposed rule (83 FR 35970) that it is not
appropriate to redistribute weight to the cost performance category for
the 2019 MIPS performance period because MIPS eligible clinicians have
limited experience being scored on cost measures for purposes of MIPS.
In addition, we were concerned that there would be limited measures in
the cost performance category under our proposals for the 2019 MIPS
performance period and stated that it may be appropriate to delay
shifting additional weight to the cost performance category until
additional measures are developed. However, we also noted that cost is
a critical component of the Quality Payment Program and believe placing
additional emphasis on the cost performance category in future years
may be appropriate. Therefore, we solicited comment on redistributing
weight to the cost performance category in future years.
We thank commenters for their input and will take this input into
consideration in future years.
(c) Final Score Calculation
We proposed to revise the formula at Sec. 414.1380(c) for
calculating the final score (83 FR 35970). We did not propose to
continue to add the small practice bonus to the final score for the
2021 MIPS payment year and proposed to add a small practice bonus to
the quality performance category score instead starting with the 2021
MIPS payment year (83 FR 35950 through 35951). Therefore, we proposed
to revise the formula to omit the small practice bonus from the final
score calculation beginning with the 2021 MIPS payment year (83 FR
35970). We requested public comments on this proposal.
Although we received several comments on the small practice bonus,
we did not receive any comments on our proposed revisions to the
formula to calculate the final score. We discuss our policy for our
revised small practice bonus in the quality performance category in
section III.I.3.i.(1)(b)(viii) of this final rule.
After consideration of public comments, we are finalizing our
proposed revisions to Sec. 414.1380(c) as proposed.
In the CY 2019 PFS proposed rule, we solicited comments on
approaches to simplify calculation of the final score (83 FR 35970). We
thank commenters for their input and will take this input into
consideration in future years.
j. MIPS Payment Adjustments
(1) Final Score Used in Payment Adjustment Calculation
For our previously established policies regarding the final score
used in payment adjustment calculations, we refer readers to the CY
2017 Quality Payment Program final rule (81 FR 77330 through 77332) and
the CY 2018 Quality Payment Program final rule (82 FR 53785 through
53787). Under our policies, for groups submitting data using the TIN
identifier, we will apply the group final score to all the TIN/NPI
combinations that bill under that TIN during the performance period (82
FR 53785). We proposed to modify this policy for the application of the
group final score, beginning with the 2019

[[Page 59879]]

performance period/2021 MIPS payment year (83 FR 35971). We proposed a
15-month window that starts with the second segment of the MIPS
determination period (October 1 prior to the MIPS performance period
through September of the MIPS performance period) and also includes the
final 3 months of the calendar year of the performance period (October
1 through December 31 of the performance period year) (83 FR 35971). We
proposed for groups submitting data using the TIN identifier, we would
apply the group final score to all of the TIN/NPI combinations that
bill under that TIN during the proposed 15-month window (83 FR 35971).
We stated that we believe that partially aligning with the second
segment of the MIPS determination period creates consistency with our
eligibility policies that informs a group or eligible clinician of who
is eligible. We refer readers to the CY 2019 PFS proposed rule (83 FR
35884 through 35886) where we discuss our proposals related to MIPS
determination periods.
We noted that, if a MIPS eligible clinician's TIN/NPI combination
was not part of the group practice during the MIPS determination
period, the TIN/NPI combination would not be identified in our system
at the start of the MIPS data submission period; however, if the MIPS
eligible clinician qualifies to receive the group final score under our
proposal, we would apply the group final score to the MIPS eligible
clinician's TIN/NPI combination as soon as the information becomes
available.
We solicited comments on the above proposal.
Comment: One commenter supported the concept of assigning a group
score to clinicians who are in a group during the final 3 months of the
calendar year of the performance period, stating that it is
administratively burdensome for large organizations to track clinicians
who join their practice during the last 3 months of the calendar year
of the performance period and determine whether or not their previous
practice intends to submit data on their behalf for the same calendar
year of the performance period.
Response: We thank the commenter for their support.
Comment: One commenter expressed concern with the 15-month gap
between the end of the first segment of the MIPS determination period
and the end of the calendar year of the MIPS performance period for
clinicians in groups who qualify for a group final score. The commenter
stated that many clinicians move from one TIN to another and
recommended we allow groups to report both on behalf of individual
clinicians or as a group for all clinicians who have assigned their
billing rights to the TIN during the calendar year of the performance
period.
Response: We realize that the first segment of the MIPS
determination period, as codified in this final rule at Sec. 414.1305,
ends 15 months before the end of the calendar year of the performance
period; however, we believe the performance of a group should coincide,
to the extent possible, with clinicians who are in the group during the
performance period. Therefore, we believe it is appropriate to use the
15-month window which includes the second segment of the MIPS
determination period and the last 3 months of the calendar year of the
performance period. We note that group reporting is an option and
practices may elect to submit for individual eligible clinicians,
rather than as a group, as long as eligible clinicians are identified
prior to end of the second segment of the MIPS determination period. As
discussed in section III.I.3.i.(2)(b)(ii)(C) of this final rule, we do
not have the ability to accept data for new group practices formed in
the last 3 months of the calendar year of the performance period, or
for individual MIPS eligible clinicians who switch practices in the
last 3 months of the calendar year of the performance period if their
new practice is not participating in MIPS as a group.
Comment: One commenter did not support the proposed 15-month
window, citing the need for additional clarity and guidance to avoid
complexity and confusion, and suggested that CMS provide examples of
how this policy would apply in different scenarios. This commenter also
recommended that CMS consider the implications of the proposal on
clinician employment and how the proposal may negatively impact the
ability of clinicians to switch practices.
Response: We do not agree that this proposal would cause confusion
or add complexity. We believe the 15-month window aligns with our
eligibility policies and better informs clinicians about their
eligibility, streamlining the program. For example, for the 2019 MIPS
performance period, if an eligible clinician joins a group practice in
November of 2019 and that group practice existed prior to the last 3
months of the year (that is, prior to October 1, 2019) and submits MIPS
data as a group, we would apply the group final score to that eligible
clinician if the clinician bills under the group's TIN during the
proposed 15-month window. Another example is a MIPS eligible clinician
who joins a group practice in October of 2018 and that group practice
submits MIPS data as a group for the 2019 MIPS performance period; for
the 2019 performance period, we would apply the group final score to
that eligible clinician if the clinician bills under the group's TIN
during the proposed 15-month window. We appreciate the suggestion to
consider the policy's implications on clinician employment and will
take this into consideration in future rulemaking.
After consideration of the comments we received, we are finalizing
our proposed 15-month window that starts with the second segment of the
MIPS determination period (October 1 prior to the calendar year of the
performance period through September 30 of the calendar year of the
performance period) and also includes the final 3 months of the
calendar year of the performance period (October 1 through December 31
of the calendar year of the performance period). We are also finalizing
that for groups submitting data using the TIN identifier, we will apply
the group final score to all of the TIN/NPI combinations that bill
under that TIN during the 15-month window. We refer readers to section
III.I.3.i.(2)(b)(ii)(C) of this final rule for a detailed discussion of
the reweighting of the quality, cost, improvement activities and
Promoting Interoperability performance categories for MIPS eligible
clinicians who join a group practice in the final 3 months of the
calendar year of the performance period.
(2) Establishing the Performance Threshold
Under section 1848(q)(6)(D)(i) of the Act, for each year of MIPS,
the Secretary shall compute a performance threshold with respect to
which the final scores of MIPS eligible clinicians are compared for
purposes of determining the MIPS payment adjustment factors under
section 1848(q)(6)(A) of the Act for a year. The performance threshold
for a year must be either the mean or median (as selected by the
Secretary, and which may be reassessed every 3 years) of the final
scores for all MIPS eligible clinicians for a prior period specified by
the Secretary.
Section 1848(q)(6)(D)(iii) of the Act included a special rule for
the initial 2 years of MIPS, which requires the Secretary, prior to the
performance period for such years, to establish a performance threshold
for purposes of determining the MIPS payment adjustment factors under
section 1848(q)(6)(A) of the Act and an additional performance
threshold for purposes of determining the additional MIPS payment
adjustment factors under section 1848(q)(6)(C) of the Act, each of

[[Page 59880]]

which shall be based on a period prior to the performance period and
take into account data available for performance on measures and
activities that may be used under the performance categories and other
factors determined appropriate by the Secretary. Section 51003(a)(1)(D)
of the Bipartisan Budget Act of 2018 amended section 1848(q)(6)(D)(iii)
of the Act to extend the special rule to apply for the initial 5 years
of MIPS instead of only the initial 2 years of MIPS.
In addition, section 51003(a)(1)(D) of the Bipartisan Budget Act of
2018 added a new clause (iv) to section 1848(q)(6)(D) of the Act, which
includes an additional special rule for the third, fourth, and fifth
years of MIPS (the 2021 through 2023 MIPS payment years). This
additional special rule provides, for purposes of determining the MIPS
payment adjustment factors under section 1848(q)(6)(A) of the Act, in
addition to the requirements specified in section 1848(q)(6)(D)(iii) of
the Act, the Secretary shall increase the performance threshold for
each of the third, fourth, and fifth years to ensure a gradual and
incremental transition to the performance threshold described in
section 1848(q)(6)(D)(i) of the Act (as estimated by the Secretary)
with respect to the sixth year (the 2024 MIPS payment year) to which
the MIPS applies.
To determine a performance threshold to propose for the third year
of MIPS (2019 MIPS performance period/2021 MIPS payment year), in the
CY 2019 PFS proposed rule (83 FR 35971), we again relied upon the
special rule in section 1848(q)(6)(D)(iii) of the Act, as amended by
51003(a)(1)(D) of the Bipartisan Budget Act of 2018. As required by
section 1848(q)(6)(D)(iii) of the Act, we considered data available
from a prior period with respect to performance on measures and
activities that may be used under the MIPS performance categories. In
accordance with newly added clause (iv) of section 1848(q)(6)(D) of the
Act, we also considered which data could be used to estimate the
performance threshold for the 2024 MIPS payment year to ensure a
gradual and incremental transition from the performance threshold we
would establish for the 2021 MIPS payment year. In the CY 2019 PFS
proposed rule (83 FR 35971), we noted that we considered using the
final scores for the 2017 MIPS performance period/2019 MIPS payment
year; however, the data used to calculate the final scores was
submitted through the first quarter of 2018, and final scores for MIPS
eligible clinicians were not available in time for us to use in our
analyses. We noted that if technically feasible, we would consider
using the actual data used to determine the final scores for the 2019
MIPS payment year to estimate a performance threshold for the 2024 MIPS
payment year in the final rule.
Because the final scores for MIPS eligible clinicians were not yet
available at the time of the CY 2019 PFS proposed rule, we reviewed the
data relied upon for the CY 2017 Quality Payment Program final rule
regulatory impact analysis (81 FR 77514 through 77536) as we believed
it was the best data available to us to estimate the actual data for
the 2017 MIPS performance period/2019 MIPS payment year (83 FR 35971).
Please refer to the CY 2019 PFS proposed rule (83 FR 35971 through
35973) for more details about the data we used.
In accordance with section 1848(q)(6)(D)(i) of the Act, the
performance threshold for the 2024 MIPS payment year would be either
the mean or median of the final scores for all MIPS eligible clinicians
for a prior period specified by the Secretary. In the CY 2019 PFS
proposed rule (83 FR 35972), we stated that when we analyzed the
estimated final scores for the first year of the program (the 2019 MIPS
payment year), the mean final score was between 63.50 and 68.98 points
and the median was between 77.83 and 82.5 points based on the different
participation assumptions. For purposes of estimating the performance
threshold for the 2024 MIPS payment year, we used the mean final score
based on data used for the CY 2017 Quality Payment Program final rule
regulatory impact analysis (81 FR 77514 through 77536), which resulted
in an estimated performance threshold between 63.50 and 68.98 points
for the 2024 MIPS payment year. We noted that this is only an
estimation we are providing in accordance with section
1848(q)(6)(D)(iv) of the Act, and we will propose the actual
performance threshold for the 2024 MIPS payment year in future
rulemaking.
We proposed a performance threshold of 30 points for the 2021 MIPS
payment year to be codified at Sec. 414.1405(b)(6) (83 FR 35972). A
performance threshold of 30 points would be a modest increase over the
performance threshold for the 2020 MIPS payment year (15 points), and
we stated that we believe it would provide a gradual and incremental
transition to the performance threshold we will establish for the 2024
MIPS payment year, which we have estimated would be between 63.50 and
68.98 points.
We stated that we want to encourage continued participation and the
collection of meaningful data by MIPS eligible clinicians. A higher
performance threshold would help MIPS eligible clinicians strive to
achieve more complete reporting and better performance and prepare MIPS
eligible clinicians for the 2024 MIPS payment year. However, a
performance threshold set too high could also create a performance
barrier, particularly for MIPS eligible clinicians who did not
previously participate in PQRS or the EHR Incentive Programs.
Additionally, we stated that we believe a modest increase from the
performance threshold for the 2020 MIPS payment year would be
particularly important to reduce the burden for MIPS eligible
clinicians in small or solo practices. We stated that we believe that
active participation of MIPS eligible clinicians in MIPS will improve
the overall quality, cost, and care coordination of services provided
to Medicare beneficiaries.
In the CY 2019 PFS proposed rule (83 FR 35972), we noted that we
heard from stakeholders requesting that we continue a low performance
threshold and from stakeholders that requested we ramp up the
performance threshold to help MIPS eligible clinicians prepare for a
future performance threshold of the mean or median of final scores and
to meaningfully incentivize higher performance. We also noted that we
heard from stakeholders who stated a higher performance threshold may
incentivize higher performance by MIPS eligible clinicians through
higher positive MIPS payment adjustments for those who exceed the
performance threshold. We noted our belief that a performance threshold
of 30 points for the 2021 MIPS payment year would provide a gradual and
incremental increase from the performance threshold of 15 points for
the 2020 MIPS payment year and could incentivize higher performance by
MIPS eligible clinicians.
We also noted our belief that a performance threshold of 30 points
represents a meaningful increase compared to 15 points, while
maintaining flexibility for MIPS eligible clinicians in the pathways
available to achieve this performance threshold, and we provided
examples to support our belief in the CY 2019 PFS proposed rule (83 FR
35972). We invited public comment on the proposal to set the
performance threshold for the 2021 MIPS payment year at 30 points (83
FR 35972). Alternatively, we considered whether the performance
threshold should be set at a higher or lower number, for example, 25
points or 35 points, and also sought comment on

[[Page 59881]]

alternative numerical values for the performance threshold for the 2021
MIPS payment year (83 FR 35972).
We solicited comments on the above proposal.
Comment: Many commenters supported the proposed performance
threshold of 30 points, indicating that the increase is reasonable; is
aligned with what they believe to be Congress's intent to ensure that
clinicians continue to be held accountable for quality and cost; is not
a significant change from the prior year; encourages clinicians to
increase their engagement and performance in MIPS; and is low enough to
protect eligible clinicians who may not have experience reporting in
MIPS from negative payment adjustments. One commenter stated that
raising the performance threshold may help limit the flattening impact
of the overall cost performance category score. One commenter stated
the modest increase would not disadvantage small practices if the small
practice bonus and other special scoring policies remain available to
them and is reasonable considering that a fair portion of clinicians
are excluded from MIPS under the low-volume threshold.
Response: We thank the commenters for their support.
Comment: Many commenters did not support the proposed performance
threshold of 30 points and stated it is too high, is not gradual
enough, would be unduly taxing, and many eligible clinicians are still
adapting to the complexities of the MIPS program. Several commenters
did not support the performance threshold citing the number of policy
changes to the MIPS program and stated that group practices and
clinicians, including newly eligible clinicians, should gain experience
with MIPS policy changes, including changes to episode-based cost
measures and the restructuring of the Promoting Interoperability
performance category, before the performance threshold is raised.
Several commenters recommended a performance threshold of 20 points
given the number of changes being proposed. Commenters also indicated
20 points would help newly eligible clinicians adjust to program
reporting requirements and that it could be met or exceeded by
reporting on 6 quality measures that receive at least 3 points per
measure and one high weighted improvement activity or 2 medium weighted
improvement activities to avoid a negative MIPS payment adjustment. A
few commenters indicated that clinicians need more time to be educated
about the MIPS program.
Response: We acknowledge the concerns submitted by many commenters.
We recognize that many requirements and scoring policies in the MIPS
program have changed since the 2017 MIPS performance period/2019 MIPS
payment year, but we believe the proposed performance threshold of 30
points is an appropriate increase that encourages increased
participation and engagement in the MIPS program and that incentivizes
clinicians to transition to value-based care with a focus on the
delivery of high-value care.
We also do not believe that increasing the performance threshold to
30 points is unreasonable or too steep, but is rather a moderate step
that encourages clinicians to gain experience with all MIPS performance
categories. In the CY 2019 PFS proposed rule, we estimated the
performance threshold we would establish for the 2024 MIPS payment year
would be between 63.50 and 68.98 points. This information was based on
year 1 estimates from the regulatory impact analysis (83 FR 35972; 81
FR 77514 through 77536). When we looked at the actual final scores for
MIPS eligible clinicians for the 2017 MIPS performance period/2019 MIPS
payment year, we found the mean final score was 74.01 points and the
median final score was 88.97 points. As discussed in section VII.F.8.d.
of the Regulatory Impact Analysis (RIA) of this final rule, we also
estimated the potential final scores for the 2019 MIPS performance
period/2021 MIPS payment year. In the RIA, we updated our estimates by
using data submitted for the first year of MIPS (2017 MIPS performance
period/2019 MIPS payment year) and applying the scoring and eligibility
policies for the third year of MIPS (the 2019 MIPS performance period/
2021 MIPS payment year). In the RIA, we estimated the mean final score
for the 2019 performance period/2021 MIPS payment year at 69.53 points
and the median final score at 78.72 points. Based on these numbers, we
estimate the performance threshold that we would establish for the 2024
MIPS payment year would likely be over 65 points. We believe that if we
set the performance threshold at 20 points (or another number lower
than 30 points) for the 2021 MIPS payment year, then the increases in
the performance threshold for each of the 2022 and 2023 MIPS payment
years would have to be steeper to ensure a gradual and incremental
transition to the performance threshold for the 2024 MIPS payment year,
in accordance with 1848(q)(6)(D)(iv) of the Act.
Additionally, we recognize that some policy changes, such as those
finalized in this final rule for the Promoting Interoperability
performance category, the impact of topped out measures on the quality
performance category, the increased weighting of the cost performance
category, and the introduction of episode-based cost measures may
dampen final scores because it will be more difficult to achieve a
perfect performance category score of 100 percent. However, we believe
there are also many options for a MIPS eligible clinician, including a
newly eligible clinician, to earn a final score at or above a
performance threshold of 30 points that do not require a perfect score
in every performance category and that these policies do not preclude a
MIPS eligible clinician from performing well. For example, a MIPS
eligible clinician that submits the maximum number of improvement
activities (achieving 40 points out of a possible 40 points) that is
weighted at 15 percent of the final score (100 percent improvement
activities performance category score x 15 percent x 100 equals 15
points toward the final score) and achieves a quality performance
category score of 35 percent \31\ that could be achieved through a
minimum of complete reporting of quality measures at varying levels of
performance (35 percent quality performance category score x 45 percent
x 100 equals 15.75 points toward the final score) would qualify for
30.75 points and exceed the performance threshold. When we also
consider the cost and Promoting Interoperability performance categories
scores, clinicians have even more options to exceed a 30-point
performance threshold. While the performance threshold could be met or
exceeded without clinician participation in the quality performance
category, we encourage clinicians to participate in multiple
performance categories, including the quality performance category, to
help facilitate successful participation in MIPS when the performance
threshold will be increased in future years and to align with the MIPS
program's focus on value-based care and the delivery of high quality
care for Medicare beneficiaries.
---------------------------------------------------------------------------

\31\ The score for the quality performance category would be (6
measure achievement points x 1 measure plus 3 measure achievement
points x 5 measures)/60 total possible achievement points or 35
percent. This assumes an outcome measure is submitted. That score
could be higher if the clinician qualifies for bonuses in the
quality performance category.
---------------------------------------------------------------------------

We agree with commenters about the need to educate clinicians,
including newly eligible clinicians, about MIPS program policies and
policy changes from year to year and encourage

[[Page 59882]]

clinicians to utilize the resources available to educate clinicians
about the MIPS program at the CMS Quality Payment Program Resource
library at https://www.cms.gov/Medicare/Quality-Payment-Program/Resource-Library/Resource-library.html.
Comment: Several commenters recommended a lower performance
threshold specifically for eligible clinicians in their first year of
MIPS eligibility, citing that this flexibility is more equitable and
allows for a greater chance of successful participation, is a
reasonable approach, and that 30 points creates an unlevel playing
field. A few commenters recommended 25 points and other scoring
accommodations for newly eligible clinicians, including occupational
therapists and physical therapists. A few commenters suggested
alternative performance thresholds for newly eligible clinicians
including 3 points and a modified ``pick your pace'' threshold for
these clinicians. One commenter recommended a performance threshold of
20 points and stated a 30-point performance threshold is a very high
standard for eligible clinicians in their first year of eligibility.
Response: As described in section III.I.3.j.(2) of this final rule,
the MIPS program is still ramping up, and we will continue to increase
the performance threshold to ensure a gradual and incremental
transition to the performance threshold for the 2024 MIPS payment year
(year 6). Therefore, a clinician who is a MIPS eligible clinician
beginning with the 2021 MIPS payment year would have 4 years in the
program to ramp up to year 6. Conversely, a clinician who first becomes
a MIPS eligible clinician in a later year would be afforded less time
to ramp up the closer the program gets to year 6. We refer readers to
section III.I.3.a. of this final rule for our discussion of new
eligible clinician types.
Comment: Many commenters stated that CMS should not increase the
performance threshold until there is actual MIPS participation data
available to analyze and share with clinicians, indicating that there
is insufficient historical MIPS data on which to set benchmarks and
determine the feasibility of the current performance threshold, the
program is still in its early stages, and that use of actual data would
provide eligible clinicians a greater sense of how they performed in
the program overall.
Response: We appreciate the commenters' concerns with the proposed
performance threshold and their request for a delay in increasing the
performance threshold until we have more information about how
clinicians are actually performing under MIPS. As discussed earlier in
this section, we estimate that we would likely set the performance
threshold for the 2024 MIPS payment year at over 65 points. We did
analyze the actual final scores for the 2019 MIPS payment year and
found the mean final score was 74.01 points and the median final score
was 88.97 points for MIPS eligible clinicians. We believe that setting
the performance threshold at 30 points for the 2019 performance period/
2021 MIPS payment year is appropriate because it encourages increased
participation and prepares clinicians for the additional participation
requirements to meet or exceed the performance thresholds that will be
set for later years. Additionally, we do not believe that keeping the
performance threshold at 15 points (which was the performance threshold
for the 2020 MIPS payment year) would provide the gradual and
incremental transition to the performance threshold for the 2024 MIPS
payment year required by section 1848(q)(6)(D)(iv) of the Act.
We also note that eligible clinicians have received performance
feedback based on their performance in year 1 of MIPS. As previously
finalized in the CY 2018 Quality Payment Program final rule (82 FR
53801 through 53802), on an annual basis, beginning July 1, 2018,
performance feedback will be provided to MIPS eligible clinicians and
groups for the quality and cost performance categories for the 2017
performance period, and if technically feasible, for the improvement
activities and advancing care information (now known as Promoting
Interoperability) performance categories. For details on the release of
the feedback reports for the first year of MIPS, we refer readers to
section III.I.3.g. of this final rule.
Comment: Several commenters did not support the proposed
performance threshold of 30 points, stating their belief that it
burdens smaller practices, especially individual clinicians who are
unable to afford CEHRT. A few commenters recommended that CMS consider
a bonus for solo practitioners.
Response: We acknowledge the concerns of commenters regarding the
potential burden on small practices, particularly solo practitioners.
We also recognize the unique challenges for solo practitioners who
participate in MIPS and have established a set of policies for small
practices that apply to solo practitioners as well. The special
policies available for small practices include the small practice bonus
which is finalized in section III.I.3.i.(1)(b)(viii) of this final
rule; the provisions related to the assignment of 3 points for measures
that do not meet data completeness criteria which are finalized in
section III.I.3.i.(1)(b)(v) of this final rule; the significant
hardship exception for Promoting Interoperability performance category
and the associated reweighting policies available for small practices
(CY 2018 Quality Payment Program final rule (82 FR 53683)); and special
scoring provisions available for the improvement activities performance
category (81 FR 77185, 77188; 82 FR 53656. We also note that clinicians
in small practices are more likely than clinicians in larger practices
to fall below one of the low-volume criteria and would not be required
to submit to MIPS; however, if they exceed at least one, but not all,
of the low volume criteria, then they would be able to take advantage
of the opt-in policy. We refer readers to section III.I.3.c. of this
final rule for more details.
Comment: A few commenters recommended a more modest increase to the
performance threshold and asked us to consider specialty-specific
performance thresholds, or special scoring policies for clinicians in
specialty practices, stating this would allow for more fair comparisons
among clinicians. One commenter stated concerns with ambulatory
surgical center-based clinicians being able to meet a 30-point
threshold and requested that CMS consider scoring relief for ambulatory
surgical center-based clinicians and groups. One commenter stated
concerns for certified registered nurse anesthetists (CRNAs) meeting
the performance threshold, citing the lack of anesthesia-related
measures, low achievable points due to quality measure benchmarking,
the lack of applicable cost measures, and the inability of CRNAs to
participate in the Promoting Interoperability performance category that
places a significant amount of time, money and resources into achieving
performance scores to meet the minimum performance threshold. One
commenter did not support the proposed performance threshold and
believed that clinicians who are not capable of submitting data for
more than one MIPS performance category could not meet the performance
threshold.
Response: We appreciate the unique challenges faced by MIPS
eligible clinicians that are in specialty practices, including
clinicians based in ambulatory surgical centers and CRNAs. However, we
believe that different performance criteria for certain types of
clinicians would create more confusion and burden than a cohesive set
of criteria. We also do not believe the

[[Page 59883]]

proposed increase in the performance threshold is overly aggressive or
unfair to specialty practices and note that there are multiple pathways
for clinicians, including specialty practices, to meet or exceed the
performance threshold. We also believe that except for a few
circumstances, such as extreme and uncontrollable circumstances, rare
cases where there are no quality measures, or clinicians joining an
existing practice (existing TIN) during the final 3 months of the
calendar year in which the performance period occurs (the performance
period year) that is not participating in MIPS as a group, most MIPS
eligible clinicians would have sufficient measures and activities
available and applicable to them for the quality and improvement
activities performance categories and would be scored on these two
categories. We also have policies in place, such as data validation
process discussed in section III.I.3.i.(1)(b)(vii) of this final rule,
to assess if clinicians have fewer than 6 measures available and
applicable for the quality performance category. We refer the readers
to the discussion of our reweighting policies for extreme and
uncontrollable circumstances at section III.I.3.i.(2)(b)(ii) of this
final rule.
Comment: A few commenters supported keeping a performance threshold
of 15 points to minimize administrative burdens as part of the
``Patients over Paperwork'' initiative and to give clinicians adequate
time to adjust their practice to meet the program's requirements.
Response: We are mindful of the efforts and requirements for
eligible clinician participation in MIPS and agree that many clinicians
need time to become familiar with the program's policies and
requirements and gain experience with increased participation under the
MIPS program. However, we do not believe that maintaining the
performance threshold at 15 points for the 2019 performance period/2021
MIPS payment year appropriately encourages clinicians to actively
participate in MIPS and incentivizes clinicians to transition to value-
based care with a focus on the delivery of high-value care.
Additionally, we do not believe that keeping the performance threshold
at 15 points (which was the performance threshold for the 2020 MIPS
payment year) would provide the gradual and incremental transition to
the performance threshold for the 2024 MIPS payment year that the
statute requires. We believe a meaningful increase to a performance
threshold of 30 points maintains appropriate flexibility for clinicians
to meet or exceed the performance threshold, while requiring increased
participation over the level of engagement required to meet or exceed
the 15-point threshold for year 2 of MIPS. We also believe the
increased participation better prepares clinicians to succeed under
MIPS in future years, will encourage a transition to the MIPS program's
focus on value-based care, and will improve the overall quality, cost,
and care coordination of services to Medicare beneficiaries.
Comment: Several commenters recommended a higher performance
threshold believing that the proposed performance threshold punishes
eligible clinicians who have invested time and money to achieve high
MIPS performance, compromises the ability of high performers to earn
the maximum payment adjustment, and dilutes program effectiveness to
drive quality improvement and reduce spending growth. A few commenters
recommended a performance threshold between 30 points and 60 points.
One commenter recommended a performance threshold of 50 points, stating
it would better reward clinicians and groups who are engaged with the
program and encourage the examination of alternative payment models.
Response: The MIPS statute requires budget neutrality, and
clinicians will receive a positive, negative, or neutral payment
adjustment factor that is determined by their performance and the
distribution of final scores across all MIPS eligible clinicians;
accordingly, high performers would likely receive higher payment
adjustments if fewer MIPS eligible clinicians meet or exceed the
performance threshold. While a higher performance threshold provides a
greater financial reward for high performers, we believe the proposal
of 30 points is warranted to encourage clinician participation in MIPS
and to encourage a movement toward value-based care with a focus on the
delivery of high quality care. We also believe that the additional
performance threshold for exceptional performance discussed later in
section III.I.3.j.(3) of this final rule provides an additional
financial incentive and financial reward for high performers and will
continue to incentivize their exceptional performance. Moreover, we
believe setting the performance threshold higher than 30 points would
not provide a gradual and incremental transition to the performance
threshold for the 2024 MIPS payment year, as required by the statute,
but rather would result in a sharp increase over the performance
threshold of 15 points for the 2020 MIPS payment year.
After consideration of the comments, we are finalizing our proposal
to set the performance threshold at 30 points for the 2021 MIPS payment
year as proposed. We are codifying the performance threshold for the
2021 MIPS payment year and finalizing the regulation text at Sec.
414.1405(b)(6) as proposed.
We also solicited comment on our approach to estimating the
performance threshold for the 2024 MIPS payment year, which in the CY
2019 PFS proposed rule we based on the estimated mean final score for
the 2019 MIPS payment year (83 FR 35972). We were particularly
interested in whether we should use the median, instead of the mean,
and whether in the future we should estimate the mean or median based
on the final scores for another MIPS payment year. We also solicited
comment on whether establishing a path forward to a performance
threshold for the 2024 MIPS payment year that provides certainty to
clinicians and ensures a gradual and incremental increase from the
performance threshold for the 2021 MIPS payment year to the estimated
performance threshold for the 2024 MIPS payment year would be
beneficial, and whether it would be beneficial for MIPS eligible
clinicians to know in advance the performance threshold for the 2022
and 2023 MIPS payment years to encourage and facilitate increased
clinician engagement and prepare clinicians for meeting the performance
threshold for the 2024 MIPS payment year.
We thank commenters for their input on these topics and will take
this input into consideration in future years.
(3) Additional Performance Threshold for Exceptional Performance
Section 1848(q)(6)(D)(ii) of the Act requires the Secretary to
compute, for each year of the MIPS, an additional performance threshold
for purposes of determining the additional MIPS payment adjustment
factors for exceptional performance under section 1848(q)(6)(C) of the
Act. For each such year, the Secretary shall apply either of the
following methods for computing the additional performance threshold:
(1) The threshold shall be the score that is equal to the 25th
percentile of the range of possible final scores above the performance
threshold determined under section 1848(q)(6)(D)(i) of the Act; or (2)
the threshold shall be the score that is equal to the 25th percentile
of the actual final scores for MIPS eligible clinicians with final
scores at or above the performance threshold for the prior period
described in section 1848(q)(6)(D)(i) of the Act.
Under section 1848(q)(6)(C) of the Act, a MIPS eligible clinician
with a

[[Page 59884]]

final score at or above the additional performance threshold will
receive an additional MIPS payment adjustment factor and may share in
the $500,000,000 of funding available for the year under section
1848(q)(6)(F)(iv) of the Act.
As we discussed in the CY 2019 PFS proposed rule (83 FR 35971), we
relied on the special rule under section 1848(q)(6)(D)(iii) of the Act,
as amended by section 51003(a)(1)(D) of the Bipartisan Budget Act of
2018, to propose a performance threshold of 30 points for the 2021 MIPS
payment year. The special rule under section 1848(q)(6)(D)(iii) of the
Act also applies for purposes of establishing an additional performance
threshold for a year. For the 2021 MIPS payment year, we proposed to
again decouple the additional performance threshold from the
performance threshold (83 FR 35973 through 35974).
During the time period in which we were drafting the CY 2019 PFS
proposed rule, we did not have actual MIPS final scores for a prior
performance period. We noted in the CY 2019 PFS proposed rule (83 FR
35973) that if we did not decouple the additional performance threshold
from the performance threshold, then we would have to set the
additional performance threshold at the 25th percentile of possible
final scores above the performance threshold. With a performance
threshold set at 30 points, the range of total possible points above
the performance threshold is 30.01 to 100 points and the 25th
percentile of that range is 47.5, which is less than one-half of the
possible 100 points in the MIPS final score. We stated that we do not
believe it would be appropriate to lower the additional performance
threshold to 47.5 points because we do not believe a final score of
47.5 points demonstrates exceptional performance by a MIPS eligible
clinician, as these additional incentives should only be available to
those clinicians with very high performance on the MIPS measures and
activities. Therefore, we relied on the special rule under section
1848(q)(6)(D)(iii) of the Act and proposed at Sec. 414.1405(d)(5) to
set the additional performance threshold at 80 points for the 2021 MIPS
payment year, which is higher than the 25th percentile of the range of
the possible final scores above the performance threshold (83 FR
35973).
As required by section 1848(q)(6)(D)(iii) of the Act, we took into
account the data available and the modeling described in the CY 2019
PFS proposed rule to estimate final scores for the 2021 MIPS payment
year (83 FR 35973). We stated that we believed 80 points was
appropriate to incentivize clinicians who have made greater strides to
meaningfully participate in the MIPS program to perform at even higher
levels. An additional performance threshold of 80 points would require
a MIPS eligible clinician to perform well on at least two performance
categories. We stated that, generally, a MIPS eligible clinician could
receive a maximum score of 45 points for the quality performance
category, which is below the 80-point additional performance threshold.
In addition, 80 points is at a high enough level that MIPS eligible
clinicians must submit data for the quality performance category to
achieve this target. We noted the additional performance threshold at
80 points could increase the incentive for excellent performance while
keeping the focus on quality performance.
We also stated an increase would encourage increased engagement and
further incentivize clinicians whose performance meets or exceeds the
additional performance threshold, recognizing that a fixed amount is
available for a year under section 1848(q)(6)(F)(iv) of the Act to fund
the additional MIPS payment adjustments and that the more clinicians
who receive an additional MIPS payment adjustment, the lower the
average clinician's additional MIPS payment adjustment will be.
For future years, we stated that we may consider additional
increases to the additional performance threshold.
We solicited comments on these proposals.
Comment: Many commenters recommended the additional performance
threshold remain at 70 points. Several commenters stated it would be
more difficult to reach 80 points rather than 70 points because of
proposed changes to the Promoting Interoperability performance
category, changes to quality measures, more topped out measures, the
increased weighting of the cost performance category, the introduction
of episode-based cost measures, and the removal of bonus points. One
commenter recommended that the additional performance threshold remain
at 70 points for at least another year because clinicians are still
learning to interpret their feedback reports and make adjustments to
their practices accordingly. One commenter stated that clinicians in
specialty practices without a significant breadth of reportable
measures would be adversely affected while those specialties that do
have large numbers of measures with full scoring potential would
benefit and that this was unfair and would discourage high performance
for those clinicians and groups within specialties. One commenter
indicated that the increase may cause more clinicians to report on
measures that bring more points rather than the most value to their
patients and practice. Another commenter stated the increase seemed
arbitrary and that clinicians who earn 70 points should be considered
exceptional. One commenter stated that keeping the additional
performance threshold at 70 points would allow the payment adjustment
to be spread more evenly rather than to only a select few and alleviate
some of the lack of positive payment adjustment incentive due to the
very low 30-point performance threshold.
A few commenters stated the additional performance threshold should
not be increased until information is available and data shared with
clinicians from the first 2 years of the program about the number of
eligible clinicians who were able to earn the additional payment
adjustment, including the number of psychiatrists who exceeded the
additional performance threshold during the 2017 MIPS performance
period.
Response: We note that many commenters recommended that we maintain
70 points for the additional performance threshold for the 2019
performance period/2021 MIPS payment year. However, we believe for year
3 it is appropriate to raise the bar on what is rewarded as exceptional
performance and that increasing the additional performance threshold
will encourage clinicians to increase their focus on value-based care
and enhance the delivery of high quality care for Medicare
beneficiaries. Based on our current data, our belief that raising the
additional performance threshold will incentivize continued improved
performance, and our concern that policy changes may make it
challenging for clinicians to reach an additional performance threshold
of 80 points while they are becoming familiar and comfortable with the
policy changes, we believe it is important to raise the additional
performance threshold, but by less than the original amount proposed.
Therefore, for year 3 of the MIPS program, we are finalizing the
additional performance threshold at 75 points, which is halfway between
our proposal of 80 points and the level recommended by many commenters
of 70 points.
We appreciate commenters' concerns about the proposed policy
changes for MIPS impacting clinicians' ability to exceed the additional
performance threshold. While we recognize that some of the policy
changes being

[[Page 59885]]

finalized in this rule, including new scoring policies for the
Promoting Interoperability performance category, changes to quality
measures, the identification of more topped out measures, the increased
weighting of the cost performance category, and the introduction of
episode-based cost measures, may make it more challenging for
clinicians to achieve higher scores while they are becoming more
familiar and comfortable with these new policies, we also believe these
policy changes help simplify and streamline the MIPS program and reduce
overall burden after an initial adjustment period. Thus, we believe it
is appropriate to slightly increase the additional performance
threshold for year 3 and will consider raising it more in future years.
In addition, despite these changes, we believe that 75 points is
achievable for many clinicians. Based on our most current data, we
estimated for the 2019 performance period/2021 MIPS payment year a mean
final score of 69.53 points and a median final score of 78.72 points as
discussed elsewhere in this section and in section VII.F.8.d. of the
RIA of this final rule. We also believe a modest increase above the
additional performance threshold for the 2018 MIPS performance period/
2020 MIPS payment year would result in an additional performance
threshold that is attainable and that would allow for multiple pathways
for clinicians, including clinicians in specialty practices whose
choice of applicable and available measures will likely vary according
to specialty, to perform exceptionally well and would encourage higher
performance by clinicians for year 3 of the MIPS program.
We acknowledge that the number of quality measures available to
clinicians can vary by specialty and practice. We believe our quality
performance category scoring validation policy accounts for certain
instances where clinicians have less than 6 measure available. We
believe these adjustments allow us to develop a fair comparison across
different MIPS eligible clinicians and would not preclude clinicians
from reaching the final additional performance threshold.
We also note that we have shared performance feedback with
clinicians and groups based on their performance in year 1 of MIPS and
recognize that clinicians may make adjustments to their clinical
practice in response to that feedback, and because we are trying to
balance that year 3 is a transition year with the goal of encouraging
clinicians to improve their performance and to deliver value-based,
high quality care, we believe that a moderate increase to 75 points is
appropriate.
Comment: Many commenters supported the proposal to increase the
additional performance threshold for exceptional performance to 80
points for the 2021 MIPS payment year and stated it encourages strong
performance from clinicians and health systems, supports continuous
performance improvement, motivates and holds clinicians accountable to
deliver quality care, creates a competitive playing field for high
performers, rewards clinicians who have invested time and resources and
have demonstrated success under MIPS performance standards, seems
reasonable, and is an appropriate increase for year 3 of the program.
One commenter supported the proposal because it ensures clinicians are
considering both cost and quality. One commenter stated that raising
the threshold may help with flattening the overall cost performance
score. One commenter supported the proposal because it is high enough
to identify exceptional scores, but was uncertain if it would translate
into improved patient outcomes or would meet CMS objectives. One
commenter supported the proposal should CMS continue its policies that
provide bonus points in the MIPS program and allow for claims-based
reporting.
Response: We received many comments in support of our proposal for
an additional performance threshold of 80 points. We agree with the
commenters that raising the performance threshold encourages strong
clinician performance, participation in multiple performance
categories, and continuous performance improvement; provides an
appropriate financial reward for high performers; and promotes a focus
on the delivery of high quality, value-based care by clinicians.
We also note that there were many commenters recommending that the
additional performance threshold remain at 70 points and other
commenters recommending 75 points. We have considered the totality of
the comments and are swayed by the comments requesting a more modest
increase to the additional performance threshold. We have also
considered the updated regulatory impact analysis which incorporates
Quality Payment Program year 1 data to estimate performance for the
2019 performance period/2021 MIPS payment year in section VII.F.8.d. of
this final rule and found a mean score of 69.53 points and a median
final score of 78.72 points. Given these findings, we believe that a
small decrease from the proposed additional performance threshold of 80
points that would fall between the mean and the median would help the
additional performance threshold remain attainable and would allow for
a larger number of clinicians to receive the additional payment
adjustment.
We also believe an increase in the additional performance threshold
would incentivize clinicians to increase their focus on value-based
care with an emphasis on the delivery of high quality care for
patients, but that an increase of 10 points is too steep, and thus, are
finalizing an additional performance threshold of 75 points that is
midway between our original proposal of 80 points and the additional
performance threshold for the 2018 MIPS performance period/2020 MIPS
payment year of 70 points.
Comment: A few commenters stated an increase to 80 points would
disproportionately impact small practices and make it difficult for
them to participate successfully in the MIPS program. One commenter
recommended CMS should not increase the additional performance
threshold until data was available to consider the impact on small
practices and then set a fair threshold.
Response: We recognize the unique challenges to eligible clinicians
in small practices participating in MIPS and believe the special
policies for small practices provide some relief for small practices
seeking to perform well. We refer readers to special policies for small
practices including: The small practice bonus which is finalized in
section III.I.3.i.(1)(b)(viii) of this final rule; the significant
hardship exception for the Promoting Interoperability performance
category available for small practices (CY 2018 Quality Payment Program
final rule 82 FR 53683); the special scoring provisions available for
the improvement activities performance category (81 FR 77185, 77188; 82
FR 53656); and the provisions related to the assignment of 3 points for
measures that do not meet data completeness criteria which are
finalized in section III.I.3.i.(1)(b)(v) of this final rule). We also
note that small practices are more likely than larger practices to fall
below one or more of the provisions related to the low-volume threshold
and would be able to take advantage of the opt-in policy and refer
readers to a discussion of the low-volume threshold at section
III.I.3.c. of this final rule.
We also analyzed the data referenced in section VII.F.8.d. of the
RIA of this final rule, and found that more small practices than larger
practices may find it harder to meet or exceed the additional
performance threshold. We

[[Page 59886]]

agree with commenters referenced here and elsewhere in this section
that an additional performance threshold of 80 points is too steep of
an increase from 70 points, but we believe that an increase is
appropriate for year 3 and that the current policies that provide
flexibilities for small practice provide a pathway for a successful
transition for clinicians who have made a commitment toward value and
the delivery of high quality care in the MIPS program. Based on these
competing concerns, as noted above, we are finalizing an additional
performance threshold of 75 points.
We also note that the additional performance threshold rewards
exceptional performance in the MIPS program and a clinician could
successfully participate in MIPS by meeting or exceeding the
performance threshold and receive a neutral or positive payment
adjustment.
Comment: A few commenters recommended 75 points because it is a
more modest, 5-point increase from the previous performance threshold
of 70 points. One commenter supported 75 points believing the increase
seems fair because the threshold is more attainable for many eligible
clinicians who are specialists, such as those practicing interventional
pain management, who may have difficulty identifying relevant measures
that improve patient quality of care. One commenter supported 75 points
should CMS finalize its proposal to remove claims-based reporting and
finalize its proposal to remove bonus points for improvement activities
completed using CEHRT.
Response: We agree with an additional performance threshold of 75
points. We believe for year 3 it is appropriate to raise the bar on
what is rewarded as exceptional performance and that increasing the
additional performance threshold will encourage clinicians to increase
their focus on value-based care and promote the delivery of high
quality care for patients. We also believe that a more modest increase
of 5 points, rather than an increase of 10 points, over the additional
performance threshold for year 2 is appropriate because year 3 is still
a transition year and we want to encourage increased clinician
engagement and increased performance in the MIPS program that drives
toward the delivery of value-based, high quality care for Medicare
beneficiaries. We also note that some commenters stated that the
proposed 10-point increase may have unintended consequences especially
because of the impact that proposed policy changes could have on final
scores as clinicians are becoming familiar with these changes. We want
to reward exceptional performance that, given the impact of the policy
changes in this final rule, could be less than 80 points. As such, we
are swayed by comments that an increase to 75 points is more modest and
a reasonable half-way point that still would raise the bar on what is
rewarded as exceptional performance for the 2019 MIPS performance
period.
We note that a lower additional performance threshold could reduce
the maximum additional payment adjustment that a MIPS eligible
clinician could potentially receive if the funds available (up to $500
million for the year) are distributed over more clinicians that score
above the lower additional performance threshold. For the reasons
discussed above, we believe 75 points is appropriate for year 3 and
note that the additional performance threshold will be raised in future
years.
Comment: A few commenters recommended a higher additional
performance threshold for exceptional performers. One commenter
recommended an additional performance threshold of 85 points to further
efforts to engage clinicians and groups through financial incentives
tied to metric performance. One commenter recommended a steeper scale
for awarding exceptional performance for scores of 90 points or
greater.
Response: We believe that a steeper increase in the additional
performance threshold is not appropriate given that MIPS is still in a
transition period and because of the MIPS policy changes we are making
in this final rule that include scoring changes to the Promoting
Interoperability performance category and the addition of episode-based
cost measures to the cost performance category, that could impact final
scores for year 3 of the MIPS program as eligible clinicians become
more familiar and comfortable with these policy changes. We want to
reward exceptional performance that, given the impact of our policy
changes in this final rule, could include performance below 85 or 90
points, particularly for small practices which may not have sufficient
case minimum to achieve maximum quality performance category score. We
recognize a higher additional performance threshold will allow for a
higher financial reward for high performers, but we want to encourage
participation with wider availability of this funding.
Comment: One commenter recommended that CMS increase the thresholds
in the CY 2020 performance period and going forward because higher
thresholds will result in a wider array of payment adjustments, thereby
encouraging more participation and rewarding those that invest in
improving their quality of care.
Response: We thank the commenter for the input and will take this
comment into consideration in future rule-making.
After consideration of the comments, we are not finalizing our
proposal of 80 points for the additional performance threshold and
instead are finalizing 75 points for the additional performance
threshold for the 2021 MIPS payment year. We are codifying the
additional performance threshold for the 2021 MIPS payment year and
finalizing the proposed regulation text at Sec. 414.1405(d)(5) with
modification to reflect 75 points instead of 80 points.
(4) Application of the MIPS Payment Adjustment Factors
(a) Application to the Medicare Paid Amount for Covered Professional
Services
In the CY 2018 Quality Payment Program final rule (82 FR 53795), we
finalized the application of the MIPS payment adjustment factor, and if
applicable, the additional MIPS payment adjustment factor, to the
Medicare paid amount for items and services paid under Part B and
furnished by the MIPS eligible clinician during the year. Sections
51003(a)(1)(A)(i) and 51003(a)(1)(E) of the Bipartisan Budget Act of
2018 amended sections 1848(q)(1)(B) and 1848(q)(6)(E) of the Act,
respectively, by replacing the references to ``items and services''
with ``covered professional services'' (as defined in section
1848(k)(3)(A) of the Act). Covered professional services as defined in
section 1848(k)(3)(A) of the Act are those services for which payment
is made under, or is based on, the Medicare PFS and which are furnished
by an eligible professional. As a result of these changes, the MIPS
payment adjustment factor determined under section 1848(q)(6)(A), and
as applicable, the additional MIPS payment adjustment factor determined
under section 1848(q)(6)(C) of the Act, will be applied to Part B
payments for covered professional services furnished by a MIPS eligible
clinician during a year beginning with the 2019 MIPS payment year and
not to Part B payments for other items and services.
To conform with these amendments to the statute, we proposed to
revise Sec. 414.1405(e) to apply the MIPS payment adjustment factor
and, if applicable, the additional MIPS payment adjustment factor, to
the

[[Page 59887]]

Medicare Part B paid amount for covered professional services furnished
by a MIPS eligible clinician during a MIPS payment year (beginning with
2019) (83 FR 35973 through 35974). We also proposed to revise Sec.
414.1405(e) to specify the formula for applying these adjustment
factors in a manner that more closely tracks the statutory formula
under section 1848(q)(6)(E) of the Act (83 FR 35973 through 35974).
Specifically, we proposed the following formula: In the case of covered
professional services (as defined in section 1848(k)(3)(A) of the Act)
furnished by a MIPS eligible clinician during a MIPS payment year
beginning with 2019, the amount otherwise paid under Part B with
respect to such covered professional services and MIPS eligible
clinician for such year, is multiplied by 1, plus the sum of: The MIPS
payment adjustment factor divided by 100, and as applicable, the
additional MIPS payment adjustment factor divided by 100 (83 FR 35974).
We did not receive any comments on this proposal.
We are finalizing our proposed changes to the regulation text at
Sec. 414.1405(e) as proposed. We also refer readers to section
III.I.3.a. of this final rule where we discuss the covered professional
services to which the MIPS payment adjustment could be applied. We also
refer readers to section III.I.3.c.(3) of this final rule where we
discuss other conforming edits to the regulation text at Sec. Sec.
414.1310(a), 414.1310(b), and 414.1310(d) that specify the
circumstances when the MIPS payment adjustment would not apply to
payments for covered professional services furnished by MIPS eligible
clinicians on or after January 1, 2019.
(b) Application for Non-Assigned Claims for Non-Participating
Clinicians
In the CY 2018 Quality Payment Program final rule, we did not
address the application of the MIPS payment adjustment for non-assigned
claims for non-participating clinicians. In the CY 2018 Quality Payment
Program final rule (82 FR 53795), we responded to a comment requesting
guidance on how the MIPS payment adjustment and the calculation of the
Medicare limiting charge amount would be applied for non-participating
clinicians, and we stated our intention to address these issues in
future rulemaking. Beginning with the 2019 MIPS payment year, we
proposed that the MIPS payment adjustment does not apply for non-
assigned claims for non-participating clinicians (83 FR 35974). This
approach is consistent with the policy for application of the value
modifier that was finalized in the CY 2015 PFS final rule (79 FR 67950
through 67951). Sections 1848(q)(6)(A) and 1848(q)(6)(C) of the Act
require that we specify a MIPS payment adjustment factor, and if
applicable, an additional MIPS payment adjustment factor for each MIPS
eligible clinician, and section 1848(q)(6)(E) of the Act (as amended by
section 51003(a)(1)(E) of the Bipartisan Budget Act of 2018) requires
that these payment adjustment factor(s) be applied to adjust the amount
otherwise paid under Part B for covered professional services furnished
by the MIPS eligible clinician during the MIPS payment year. When non-
participating clinicians choose not to accept assignment for a claim,
Medicare makes payment directly to the beneficiary, and the clinician
collects payment from the beneficiary. This is referred to as a non-
assigned claim. Application of the MIPS payment adjustment to these
non-assigned claims would not affect payment to the MIPS eligible
clinician. Rather, it would only affect Medicare payment to the
beneficiary. If the MIPS payment adjustment were to be applied to non-
assigned services, then the Medicare payment to a beneficiary would be
increased when the MIPS payment adjustment is positive and decreased
when the MIPS payment adjustment is negative. Although the statute does
not directly address this situation, it does suggest that the MIPS
payment adjustment is directed toward payment to the MIPS eligible
clinician and the covered professional services they furnish. We
continue to believe that it is important that beneficiary liability not
be affected by the MIPS payment adjustment and that the MIPS payment
adjustment should be applied to the amount that Medicare pays to MIPS
eligible clinicians.
On that basis, we proposed to apply the MIPS payment adjustment to
claims that are billed and paid on an assignment-related basis, and not
to any non-assigned claims, beginning with the 2019 MIPS payment year
(83 FR 35974). We do not expect this proposal would be likely to affect
a clinician's decision to participate in Medicare or to otherwise
accept assignment for a particular claim, but we solicited comment on
whether stakeholders and others believe clinician behavior would change
as a result of this policy.
We solicited comments on the above proposal.
Comment: A few commenters supported the proposal to apply the
adjustment to claims that are billed and paid on an assignment-related
basis and not to any non-assigned claims.
Response: We thank the commenters for their support.
Comment: One commenter recommended that this policy be revisited in
the next year and evaluated for unintended consequences, including
whether there are any adverse effects on Medicare beneficiaries who see
a non-participating clinician who does not accept assignment for a
claim.
Response: We thank the commenter for the input and will take this
comment into consideration in future rulemaking.
After consideration of the comments, we are finalizing our proposal
to apply the MIPS payment adjustment to claims that are billed and paid
on an assignment-related basis, and not to any non-assigned claims,
beginning with the 2019 MIPS payment year.
(c) Waiver of the Requirement To Apply the MIPS Payment Adjustment
Factors to Certain Payments in Models Tested Under Section 1115A of the
Act
(i) Overview
CMS tests models under section 1115A of the Act that may include
model-specific payments made only to model participants under the terms
of the model and not to any other providers of services or suppliers.
Some of these model-specific payments may be considered payments for
covered professional services furnished by a MIPS eligible clinician,
meaning that the MIPS payment adjustment factor, and, as applicable,
the additional MIPS payment adjustment factor (collectively referred to
as the MIPS payment adjustment factors) applied under Sec. 414.1405(e)
of our regulations would normally apply to those payments.
(ii) Summary of Proposals and Comments Received
Section 1115A(d)(1) of the Act authorizes the Secretary to waive
requirements of Title XVIII of the Act (and certain other requirements)
as may be necessary solely for the purposes of testing models under
section 1115A. We stated in the proposed rule (83 FR 35974 through
35975) that we believe it is necessary to waive the requirement to
apply the MIPS payment adjustment factors to a model-specific payment
or payments (to the extent such a payment or payments are subject to
the requirement to apply the MIPS payment adjustment factors) for
purposes of testing a section 1115A model under which such model-
specific payment or payments are made in a specified payment amount
(for example, $160 per-beneficiary, per-month); or paid according to a
methodology for calculating a model-specific payment

[[Page 59888]]

that is applied in a consistent manner to all model participants. In
both cases, applying the MIPS payment adjustment factors to these
model-specific payments would introduce variation in the amounts of
model-specific payments paid across model participants, which could
compromise the model test and the evaluation thereof.
We proposed to amend Sec. 414.1405 to add a new paragraph (f) to
specify that the MIPS payment adjustment factors applied under Sec.
414.1405(e) would not apply to certain model-specific payments as
described above for the duration of a section 1115A model's testing
beginning in the 2019 MIPS payment year (83 FR 35974 through 35975). We
proposed to use the authority under section 1115A(d)(1) of the Act to
waive the requirement to apply the MIPS payment adjustment factors
under section 1848(q)(6)(E) of the Act and Sec. 414.1405(e)
specifically for these types of payments because the waiver is
necessary solely for purposes of testing models that involve such
payments (83 FR 35974 through 35975). To illustrate how the proposed
waiver would apply, and to provide notice regarding one model-specific
payment to which this proposed waiver would apply, we included an
example in the proposed rule involving the Monthly Enhanced Oncology
Services (MEOS) payment in the Oncology Care Model (OCM) (83 FR 35975).
We solicited comment on this proposal.
The following is a summary of the public comments received in
response to our request for comment and our responses:
Comment: A few commenters supported our proposal to waive the
application of the MIPS payment adjustment factors to certain model-
specific payments. The commenters agreed that these waivers are
necessary to test models that would involve these types of model-
specific payments, and without such waivers the evaluation of certain
models could be compromised.
Response: We appreciate the commenters' support.
Comment: One commenter noted that the proposed amendment at Sec.
414.1405(f) is ambiguous as to whether paragraphs (l), (2), and (3)
refer to three different classes of payments, or to one class of
payments that meet all three conditions. The commenter suggested that
we clarify our intended policy.
Response: We clarify that only payments meeting all three
conditions set forth at Sec. 414.1405(f) will qualify for the waiver
of the MIPS payment adjustment factors under section 1848(q)(6)(E) of
the Act and Sec. 414.1405(e). We have amended Sec. 414.1405(f) to
specify that payments must meet all three conditions to reduce any
potential ambiguity, and made further amendments to Sec. 414.1405(f)
for greater clarity and readability and to more closely align with the
policy described in the preamble text of the proposed rule, including
to clarify that the regulatory text in Sec. 414.1405(f)(3) refers to
payments made in a consistent manner to all model participants,
including those participants subject to the MIPS payment adjustment
factors and participants not subject to the MIPS payment adjustment
factors.
After considering public comments, we are finalizing our proposal
to use the authority under section 1115A(d)(1) of the Act to waive the
requirement to apply the MIPS payment adjustment factors under section
1848(q)(6)(E) of the Act and Sec. 414.1405(e) specifically for
payments specified at Sec. 414.1405(f) with the clarifying amendments
described herein. As discussed in the CY 2019 PFS proposed rule (83 FR
35975), one model-specific payment to which this finalized waiver will
apply is the Monthly Enhanced Oncology Services (MEOS) payment in the
Oncology Care Model (OCM). The duration of this waiver will begin with
the 2019 MIPS payment year and continue for the duration of OCM.
We proposed to provide the public with notice that this proposed
new regulation applies to model-specific payments that the Innovation
Center elects to test in the future in two ways: first, we would update
the Quality Payment Program website (www.qpp.cms.gov) when new model-
specific payments subject to this proposed waiver are announced; and
second, we would provide a notice in the Federal Register to update the
public on any new model-specific payments to which this waiver would
apply (83 FR 35974 through 35975).
We solicited comment on this proposal.
The following is a summary of the public comments received in
response to our request for comment and our responses:
Comment: One commenter urged CMS to denote which models and model
specific payments are subject to this new policy on the Quality Payment
Program website and Federal Register as soon as possible.
Response: We plan to provide the public with notice as soon as
practicable for model-specific payments subject to this waiver via the
Quality Payment Program website (www.qpp.cms.gov), and separate notice
in the Federal Register.
After considering public comments, we are finalizing our policy as
proposed to provide the public with notice in the following two ways:
(1) We will update the Quality Payment Program website
(www.qpp.cms.gov) when new model-specific payments subject to this
waiver are announced; and (2) we will provide a notice in the Federal
Register to update the public on any new model-specific payments to
which this waiver will apply.
(d) CY 2018 Exclusion of MIPS Eligible Clinicians Participating in the
Medicare Advantage Qualifying Payment Arrangement Incentive (MAQI)
Demonstration
(i) Overview
In conjunction with releasing the CY 2019 PFS proposed rule, CMS
announced the Medicare Advantage Qualifying Payment Arrangement
Incentive (MAQI) Demonstration, established by CMS using our
demonstration authority under section 402 of the Social Security
Amendments of 1967 (as amended). The MAQI Demonstration is designed to
test whether excluding MIPS eligible clinicians who participate to a
sufficient degree in certain payment arrangements with Medicare
Advantage Organizations (MAOs) from the MIPS reporting requirements and
payment adjustments will increase or maintain participation in payment
arrangements similar to Advanced APMs with MAOs and change the manner
in which clinicians deliver care.
(ii) Summary of Proposals
We proposed to use the authority in section 402(b) of the Social
Security Amendments of 1967 (as amended) to waive requirements of
section 1848(q)(6)(E) of the Act and the regulations implementing it in
order to waive the payment consequences (positive, negative or neutral
adjustments) of the MIPS and to waive the associated MIPS reporting
requirements in 42 CFR part 414 adopted to implement the payment
consequences, subject to conditions outlined in the Demonstration. We
noted, relating to our proposal to waive payment consequences, that the
Demonstration would have the effect of removing MIPS eligible
clinicians from the population across which positive and negative
payment adjustments are calculated under MIPS, and because of the
requirement to ensure budget neutrality with regard to the MIPS payment
adjustments under section 1848(q)(6)(F)(ii) of the Act, the
Demonstration may affect the payment

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adjustments for other MIPS eligible clinicians.
We proposed that these waivers would be applicable for a MIPS
eligible clinician participating in the Demonstration if they meet
combined thresholds for Medicare payments or patients through
Qualifying Payment Arrangements with MAOs and Advanced APMs, and that
these thresholds would match the thresholds for participation in
Advanced APMs under the Medicare Option of the Quality Payment Program.
We also proposed to calculate thresholds based on aggregate
participation in Advanced APMs and Qualifying Payment Arrangements with
MAOs, without applying a specific minimum threshold to participation in
either type of payment arrangement. For purposes of the Demonstration,
we proposed to make determinations about clinicians' Qualifying Payment
Arrangements with MAOs, consistent with the criteria used for Other
Payer Advanced APMs under the Quality Payment Program and as set forth
in Sec. 414.1420. We proposed to begin the MAQI Demonstration in CY
2018, with the 2018 Performance Period, and operate the project for a
total of 5 years.
We also noted in the proposed rule that, for eligible clinicians
who are excluded from the MIPS reporting requirements and payment
adjustment under the MAQI Demonstration, we would waive the provision
in section 1848(q)(1)(A)(iii) of the Act requiring that the Secretary
shall permit any eligible clinician to voluntarily report on applicable
measures and activities. We clarify that, with this waiver, the
Demonstration will prohibit voluntary reporting under the MIPS by
eligible clinicians who participate in the Demonstration and are not
subject to the MIPS reporting requirements and payment adjustment for a
given year. This last waiver is intended to prevent potential gaming in
the form of an eligible clinician intentionally submitting data showing
poor performance for a year for which they are not subject to the MIPS
reporting requirements and payment adjustment pursuant to the terms of
the Demonstration in order to show improvement in their performance in
future years when that improvement could result in higher MIPS scoring.
(iii) Applicable Waivers
Section 402(b) of the Social Security Amendments of 1967 (as
amended) authorizes the Secretary to waive requirements of Title XVIII
that relate to payment and reimbursement in order to carry out
demonstrations under section 402(a). We proposed to use this authority
to waive certain requirements of section 1848(q) of the Act and the
regulations implementing it, specifically the payment consequences
(positive, negative or neutral adjustments) of the MIPS and the
associated MIPS reporting requirements in 42 CFR part 414 (adopted to
implement the payment consequences), subject to conditions outlined in
the Demonstration.
We solicited comment on these proposals.
The following is a summary of the public comments, relating to
proposed waivers, received in response to our request for comment and
our responses:
Comment: Many commenters supported the proposal to use
demonstration waiver authority (under section 402 of the Social
Security Amendments of 1967 (as amended)) to test the MAQI
Demonstration.
Response: We appreciate the commenters' support of the MAQI
Demonstration.
Comment: Many commenters urged CMS to use its waiver authority in
the MAQI Demonstration to allow another path towards QP status and
provide eligible clinicians with the 5 percent incentive payment
offered to QPs.
Response: Demonstration projects under the authority of section
402(a)(1)(A) of the Social Security Amendments of 1967 are intended to
test whether changes in payment or reimbursement will increase the
efficiency or economy of health care services. Our actuarial analyses
determined that a demonstration design that would grant QP status,
including a 5 percent incentive payment, to eligible clinicians who met
the thresholds would have introduced a significant level of new costs
to CMS, without adequate evidence for realizing an equal amount of
savings from the proposed interventions. Without a basis to believe
that the economy or efficiency of health care services would be
increased, we do not believe that it is appropriate to design a
demonstration with such parameters. Considering that the proposed
exclusions from MIPS reporting and payment consequences under the MAQI
Demonstration are not anticipated to have a net cost to CMS, we plan to
test whether these exclusions will increase or maintain clinician
participation in payment arrangements with MAOs that are similar to
Advanced APMs and change the manner in which clinicians deliver care.
This test is consistent with the standards set forth in section
402(a)(1)(A) of the Social Security Amendments of 1967.
Comment: Some commenters urged CMS to monitor the impact of the
Demonstration on MIPS payment adjustments, including one commenter that
expressed concern that the MIPS- eligible population pool would be
reduced and another commenter that expressed concern about whether the
potential benefits being tested under the MAQI Demonstration outweigh
any potential impacts on the level of MIPS payment adjustments.
Response: We agree that it will be important to monitor the impact
of the Demonstration on payments received by MIPS eligible clinicians
to whom the waivers do not apply, but we note that it may be
challenging to draw significant conclusions from such monitoring as
there are many variables that may impact and influence a clinician's
final MIPS payment adjustment. We plan to share information on
participation levels in the MAQI Demonstration with the public as soon
as this information is available.
Comment: A few commenters commended CMS on starting the MAQI
Demonstration in 2018, while a few commenters advised CMS to clarify
the timeline associated with a CY 2018 implementation of the
Demonstration and when determinations would be made under the
Demonstration to identify participating eligible clinicians who are
excluded from the MIPS reporting requirements and payment adjustments.
Response: We appreciate certain commenters' support for beginning
the Demonstration in CY 2018, and note that by doing so, clinicians
that meet threshold levels of participation in Qualifying Payment
Arrangements with MAOs in 2018 can be considered for exclusion from the
MIPS reporting requirements and payment adjustment under the
Demonstration a year before participation in such Qualifying Payment
Arrangements could be considered under the All-Payer Combination
Option. We anticipate collecting Qualifying Payment Arrangement and
threshold information for eligible clinicians participating in the
Demonstration starting in late fall of 2018, and making final CMS
determinations on whether eligible clinicians meet the criteria to be
excluded from the MIPS reporting requirements and payment adjustment,
based on this submitted information, by December 2018 or (January 2019
at the latest). We note that eligible clinicians participating in the
MAQI Demonstration in 2018 will be evaluated to determine whether they
meet the criteria to be excluded from MIPS reporting requirements for
the 2018 MIPS performance year, and from the

[[Page 59890]]

MIPS payment adjustment for the corresponding 2020 MIPS payment year.
Comment: Some commenters recommended that CMS make changes to the
Demonstration criteria relating to clinician eligibility for the
exclusion from the MIPS reporting requirements and payment adjustment,
such as Qualifying Payment Arrangements and thresholds.
Response: As noted in the proposed rule, we intend to use criteria
and requirements that are consistent with the Medicare and Other Payer
Advanced APM Options under the Quality Payment Program. Changing the
clinician eligibility for exclusion from the MIPS reporting
requirements and payment adjustment would not be consistent with this
intent.
We also received comments on other provisions associated with the
Demonstration.
Comment: Some commenters advised CMS to make changes to the
Demonstration application and data collection process.
Response: The application and data collection process are outside
the scope of the proposals in the CY 2019 PFS proposed rule; however,
we will seek to balance reporting burden with the need to solicit
information necessary to ensure that the demonstration is being
implemented, tested and evaluated appropriately.
Comment: A few commenters requested additional agency focus in
helping physicians and practices better understand their options under
Medicare, Medicare Advantage, the Quality Payment Program, the MAQI
Demonstration and other value-based payment arrangements.
Response: We are committed to reaching our stakeholders, including
clinicians, the technology community, private payers, and
beneficiaries, to raise awareness that Medicare is evolving quickly to
a value-based system. In addition to raising awareness that change is
occurring, we will continue current efforts to engage in a learning
process with stakeholders where they may voice opinions and suggestions
to help collaboratively drive the goals of the Quality Payment Program.
We will continue to set expectations that this will be an iterative
process, and, while change will not happen overnight, we are committed
to continuing our work to improve how Medicare pays for quality and
value, instead of the quantity of services. We will continue to reach
out to the clinician community and others to partner in the development
of ongoing education, support, and technical assistance materials and
activities to help clinicians understand program and model
requirements, how to use available tools to enhance their practices,
improve quality, reduce expenditures, and progress to participation in
Advanced APMs if that is the best choice for their practice.
We are offering support in the form of fact sheets, webinars,
online courses, and direct technical assistance to help clinicians
successfully participate in the Quality Payment Program, the MIPS or
the Advanced APM track. This range of support to help clinician
practices actively participate in the Quality Payment Program that can
be found at the following website at https://qpp.cms.gov/.
We also discussed that the Demonstration would waive the provision
in section 1848(q)(1)(A)(iii) of the Act that the Secretary shall
permit any eligible clinician to voluntarily report on applicable
measures and activities, so that the Demonstration would prohibit
reporting under the MIPS by eligible clinicians who participate in the
Demonstration and meet the thresholds to be excluded from the MIPS
reporting requirements and payment adjustment for a given year. We did
not receive any comments on this proposal. We explained that this
waiver is necessary to prevent the potential gaming opportunity wherein
participating clinicians could intentionally report artificially poor
performance under the MIPS for years in which they receive waivers from
MIPS payment consequences, then receive artificially inflated quality
improvement points under MIPS in later years when they do not receive
waivers from MIPS payment consequences. We note here that by
prohibiting reporting under MIPS we are also, in effect, disallowing
MIPS performance feedback for those clinicians who participate in the
Demonstration and meet the criteria to be excluded from the MIPS
reporting requirements and payment adjustments. Eligible clinicians who
participate in the Demonstration but are not excluded from the MIPS
reporting requirements and payment adjustment (whether through
participation in the Demonstration or otherwise) would continue to be
MIPS eligible clinicians who are subject to the MIPS reporting
requirements and payment adjustment as usual.
(iv) Summary of Finalized Policies
After considering public comments, we are finalizing our proposals
to implement the MAQI Demonstration in CY 2018 and use the authority in
section 402(b) of the Social Security Amendments of 1967 (as amended)
to waive certain requirements of section 1848(q)(6)(E) of the Act,
specifically the payment consequences (positive, negative or neutral
adjustments) of the MIPS and the associated MIPS reporting requirements
in 42 CFR part 414 adopted to implement the payment consequences,
subject to conditions outlined in the Demonstration. We are also
finalizing that we will waive the provision in section
1848(q)(1)(A)(iii) of the Act that the Secretary shall permit any
eligible clinician to voluntarily report on applicable measures and
activities, so that the Demonstration will prohibit reporting under the
MIPS by eligible clinicians who participate in the Demonstration and
meet the thresholds that will trigger application of the waivers from
the MIPS reporting requirements and payment adjustment for a given
year. Related to this waiver of the last sentence of section
1848(q)(1)(A)(iii) of the Act, MAQI Participants who are not subject to
the MIPS reporting requirements and payment adjustments will therefore
not receive MIPS performance feedback under section 1848(q)(12) of the
Act.
In addition, we are also announcing our final policies that, under
the waivers identified previously: (1) Eligibility for exclusion from
the MIPS reporting requirements and payment adjustment under the MAQI
Demonstration will be determined using thresholds of combined
participation in Qualifying Payment Arrangements and Advanced APMs that
are the same as the QP thresholds under the Medicare Option of the
Quality Payment Program codified at Sec. 414.1430(a); and (2)
Qualifying Payment Arrangements under the MAQI Demonstration will be
identified using criteria consistent with those used to identify Other
Payer Advanced APMs codified at Sec. 414.1420. To qualify for
exclusion from the MIPS reporting requirements and payment adjustment
under the MAQI Demonstration, a MAQI participating clinician must meet
combined thresholds for Medicare payments or patients through
Qualifying Payment Arrangements with MAOs and Advanced APMs, using
Demonstration thresholds that match the thresholds for participation in
Advanced APMs under the Medicare Option of the Quality Payment Program,
and based on aggregate participation in Advanced APMs and Qualifying
Payment Arrangements with MAOs, without applying a specific minimum
threshold to participation in either type of payment arrangement.

[[Page 59891]]

(e) Example of Adjustment Factors
In the CY 2019 PFS proposed rule (83 FR 35978 through 35981), we
provided a figure and several tables as illustrative examples of how
various final scores would be converted to a MIPS payment adjustment
factor, and potentially an additional MIPS payment adjustment factor,
using the statutory formula and based on our proposed policies for the
2021 MIPS payment year. We updated the figure and tables based on the
policies we are adopting in this final rule, as follows.
Figure 3 provides an example of how various final scores would be
converted to a MIPS payment adjustment factor, and potentially an
additional MIPS payment adjustment factor, using the statutory formula
and based on the policies adopted in this final rule for the 2021 MIPS
payment year. In Figure 3, the performance threshold is 30 points. The
applicable percentage is 7 percent for the 2021 MIPS payment year. The
MIPS payment adjustment factor is determined on a linear sliding scale
from zero to 100, with zero being the lowest possible score which
receives the negative applicable percentage (negative 7 percent for the
2021 MIPS payment year) and resulting in the lowest payment adjustment,
and 100 being the highest possible score which receives the highest
positive applicable percentage and resulting in the highest payment
adjustment. However, there are two modifications to this linear sliding
scale. First, there is an exception for a final score between zero and
one-fourth of the performance threshold (zero and 7.5 points based on
the performance threshold of 30 points for the 2021 MIPS payment year).
All MIPS eligible clinicians with a final score in this range would
receive the lowest negative applicable percentage (negative 7 percent
for the 2021 MIPS payment year). Second, the linear sliding scale line
for the positive MIPS payment adjustment factor is adjusted by the
scaling factor, which cannot be higher than 3.0.
If the scaling factor is greater than zero and less than or equal
to 1.0, then the MIPS payment adjustment factor for a final score of
100 would be less than or equal to 7 percent. If the scaling factor is
above 1.0, but less than or equal to 3.0, then the MIPS payment
adjustment factor for a final score of 100 would be higher than 7
percent.
Only those MIPS eligible clinicians with a final score equal to 30
points (which is the performance threshold in this example) would
receive a neutral MIPS payment adjustment. Because the performance
threshold is 30 points, we anticipate that more clinicians will receive
a positive adjustment than a negative adjustment and that the scaling
factor would be less than 1 and the MIPS payment adjustment factor for
each MIPS eligible clinician with a final score of 100 points would be
less than 7 percent.
Figure 3 illustrates an example of the slope of the line for the
linear adjustments and has been updated from prior rules, but it could
change considerably as new information becomes available. In this
example, the scaling factor for the MIPS payment adjustment factor is
0.159. In this example, MIPS eligible clinicians with a final score
equal to 100 would have a MIPS payment adjustment factor of 1.11
percent (7 percent x 0.159). (Note that this is prior to adding the
additional payment adjustment for exceptional performance, which is
explained below.)
The additional performance threshold is 75 points. An additional
MIPS payment adjustment factor of 0.5 percent starts at the additional
performance threshold and increases on a linear sliding scale up to 10
percent. This linear sliding scale line is also multiplied by a scaling
factor that is greater than zero and less than or equal to 1.0. The
scaling factor will be determined so that the estimated aggregate
increase in payments associated with the application of the additional
MIPS payment adjustment factors is equal to $500,000,000. In Figure 3,
the example scaling factor for the additional MIPS payment adjustment
factor is 0.358. Therefore, MIPS eligible clinicians with a final score
of 100 would have an additional MIPS payment adjustment factor of 3.58
percent (10 percent x 0.358). The total adjustment for a MIPS eligible
clinician with a final score equal to 100 would be 1 + 0.0111 + 0.0358
= 1.0469, for a total positive MIPS payment adjustment of 4.69 percent.

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[[Page 59892]]

[GRAPHIC] [TIFF OMITTED] TR23NO18.071

The final MIPS payment adjustments will be determined by the
distribution of final scores across MIPS eligible clinicians and the
performance threshold. More MIPS eligible clinicians above the
performance threshold means the scaling factors would decrease because
more MIPS eligible clinicians receive a positive MIPS payment
adjustment factor. More MIPS eligible clinicians below the performance
threshold means the scaling factors would increase because more MIPS
eligible clinicians would receive a negative MIPS payment adjustment
factor and relatively fewer MIPS eligible clinicians would receive a
positive MIPS payment adjustment factor.
Table 56 illustrates the changes in payment adjustments based on
the final policies from the 2019 MIPS payment year and the 2020 MIPS
payment year, and on final policies for the 2021 MIPS payment year
adopted in this final rule, as well as the statutorily required
increase in the applicable percent as required by section 1848(q)(6)(B)
of the Act.

[[Page 59893]]

[GRAPHIC] [TIFF OMITTED] TR23NO18.072

BILLING CODE 4120-01-C

We note that in this final rule, with the exception of the increase
in our small practice bonus in the quality performance category from 3
measure bonus points to 6 measure bonus points, our scoring algorithms
have not changed from the CY 2019 PFS proposed rule and that the only
policy change from the CY 2019 PFS proposed rule reflected in Figure 3
and Table 56 is that final scores greater than or equal to 75 points
qualify for the additional payment adjustment for exceptional
performance discussed at section III.I.3.j.(3) of this final rule.
Please refer to the CY 2019 PFS proposed rule (83 FR 35979 through
35981) for examples of scenarios in

[[Page 59894]]

which MIPS eligible clinicians can achieve a final score at or above
the performance threshold of 30 points for the 2021 MIPS payment year.
k. Third Party Intermediaries
We refer readers to Sec. 414.1400, the CY 2017 Quality Payment
Program final rule (81 FR 77362 through 77390) and the CY 2018 Quality
Payment Program final rule (82 FR 53806 through 53819) for our
previously established policies regarding third party intermediaries.
In the CY 2019 PFS proposed rule (83 FR 35981 through 35986), we
proposed to: (1) Define third party intermediary and require third
party intermediaries to be based in the U.S.; (2) update certification
requirements for data submission; (3) update the definition of
Qualified Clinical Data Registry (QCDR); revise the self-nomination
period for QCDRs; update of information required for QCDRs at the time
of self-nomination; update consideration criteria for approval of QCDR
measures; define the topped out timeline for QCDR measures; (4) revise
the self-nomination period for qualified registries; (5) define health
IT vendor; (6) update the definition, criteria, and requirements for
CMS-approved survey vendor; auditing criteria; and (7) revise probation
and disqualification criteria. We finalize these proposals in the
manner discussed herein.
(1) Third Party Intermediaries Definition
In the CY 2019 PFS proposed rule (83 FR 35981), at Sec. 414.1305,
we proposed a new definition to define a third party intermediary as an
entity that has been approved under Sec. 414.1400 to submit data on
behalf of a MIPS eligible clinician, group, or virtual group for one or
more of the quality, improvement activities, and Promoting
Interoperability performance categories. A QCDR, qualified registry,
health IT vendor, or CMS-approved survey vendor are considered third
party intermediaries. We also proposed to change the section heading at
Sec. 414.1400 from ``Third party data submissions'' to ``Third party
intermediaries'' to elucidate the definition and function of a third
party intermediary (83 FR 35981).
As discussed in the CY 2019 PFS proposed rule (83 FR 35981), CMS IT
systems are required to adhere to multiple agency and federal security
standards and policy. CMS policy prohibits non-U.S. citizens from
accessing CMS IT systems, and also requires all CMS program data to be
retained in accordance with U.S. Federal policy, specifically National
Institute of Standards and Technology (NIST) Special Publication (SP)
800-63, which outlines enrollment and identity proofing requirements
(levels of assurance) for federal IT system access. Access to the
Quality Payment Program would necessitate passing a remote or in-person
Federated Identity Proofing process (that is, Equifax or equivalent). A
non-U.S. based third party intermediary's potential lack of a SSN, TIN,
U.S. based address, and other elements required for identity proofing
and identity verification would impact their ability to pass the
necessary background checks. An inability to pass identity proofing may
limit or fully deny access to the Quality Payment Program if the intent
is to interact with the Quality Payment Program outside of the U.S. for
the purposes of reporting and storing data.
These requirements are existing federal policies applicable to all
HHS/CMS FISMA systems and assets, and the requirements are not specific
to the Quality Payment Program. More information on these policies is
available at the following websites: HHS Information Security and
Privacy Policy (IS2P) (https://www.hhs.gov/about/agencies/asa/ocio/cybersecurity/); CMS Information Systems Security and Privacy
Policy (IS2P2) (https://www.cms.gov/Research-Statistics-Data-and-Systems/CMS-Information-Technology/InformationSecurity/Info-Security-Library-Items/CMS-Information-Systems-Security-and-Privacy-Policy-IS2P2.html); OMB Memorandum 04-04, E-Authentication Guidance for
Federal Agencies (https://georgewbush-whitehouse.archives.gov/omb/memoranda/fy04/m04-04.pdf); and NIST SP 800-63 Digital Identity
Guidelines (https://pages.nist.gov/800-63-3/). Therefore, in the CY
2019 PFS proposed rule (83 FR 35982) we proposed to amend Sec.
414.1400(a)(4) to indicate that a third party intermediary's principle
place of business and retention of associated CMS data must be within
the U.S.
We would like to note, third party intermediaries that are
authorized by us to submit data on behalf of MIPS eligible clinicians,
groups, or virtual groups have not otherwise been evaluated for the
capabilities, quality, or any other features or its products. The
United States Government and CMS do not endorse or recommend any third
party intermediary or its products. Prior to selecting or using any
third party intermediary or its products, MIPS eligible clinicians,
groups or virtual groups should perform their own due diligence on the
entity and its products, including contacting the entity directly to
learn more about its products.
The following is a summary of the public comments received on the
``Third Party Intermediaries Definition'' proposals and our responses:
Comment: One commenter appeared to advocate that clinicians who
must comply with MACRA should be prohibited from using online and/or
software-based third party intermediaries that do not use attorneys to
advise clinicians on the law. The commenter stated that, in order to
protect clinicians from failure to comply with MACRA and to achieve
higher MACRA compliance rates, CMS should restrict MIPS participants
from using online or software-based third party intermediaries entirely
unless the use is through an EMR/EHR dashboard. In addition, the
commenter stated that CMS should only allow clinicians to achieve
compliance themselves or to achieve compliance through the use of an
attorney or an EMR/EHR dashboard.
Response: We do not believe it is appropriate to require third
party intermediaries to furnish legal advice to clinicians. If a
clinician wishes to receive legal advice regarding compliance with
MACRA, or any other law or regulation, the clinician may hire his or
her own legal counsel. To the extent the commenter is advocating to
eliminate a clinician's ability to report MIPS data through a third
party intermediary, the comment is outside the scope of the rulemaking.
Comment: One commenter provided a comment related to the proposed
opt-in policy. The commenter encouraged us to allow third-party
intermediaries, such as qualified registries, to opt-in on behalf of
clinicians and groups as a function of the services they provide and
that the clinician opt-in should be at the TIN/NPI level.
Response: The opt-in policy is discussed in section III.I.3.c.(5)
in this final rule, where we finalized that a clinician who is eligible
to opt-in would be required to make an affirmative election to opt-in
to participate in MIPS, elect to be a voluntary reporter, or by not
submitting any data the clinician is choosing to not report. We believe
that an election to opt-in to MIPS must be made by the clinician or
group through a definitive opt-in decision to participate in MIPS
regardless of the way in which the data is submitted. We agree that
after this decision is confirmed by the clinician or group it should be
deliverable through a third party intermediary, if a clinician or group
is utilizing a third party intermediary for their data submission. As a
result, the third party intermediary

[[Page 59895]]

should be able to transmit the clinician's opt-in decision to CMS.
Therefore, we are amending Sec. 414.1400(a)(4)(iv) that if the
clinician chooses to opt-in in accordance with Sec. 414.1310, the
third party intermediary must be able to transmit that decision to CMS.
We refer readers to section III.I.3.c.(5) of this final rule for more
information regarding low volume threshold exclusion.
After consideration of the public comments received, we are
finalizing our proposal, as proposed, at Sec. 414.1305, to define a
third party intermediary as an entity that has been approved under
Sec. 414.1400 to submit data on behalf of a MIPS eligible clinician,
group, or virtual group for one or more of the quality, improvement
activities, and Promoting Interoperability performance categories. A
QCDR, qualified registry, health IT vendor, or CMS-approved survey
vendor are considered third party intermediaries. We are also
finalizing our proposal, as proposed, to change the section heading at
Sec. 414.1400 from ``Third party data submissions'' to ``Third party
intermediaries'' to elucidate the definition and function of a third
party intermediary. In addition, we are finalizing our proposal, as
proposed, to amend previously finalized policies at Sec.
414.1400(a)(4) to indicate that a third party intermediary's principle
place of business and retention of associated CMS data must be within
the U.S. Lastly, we are amending Sec. 414.1400(a)(4)(iv) to state that
if the clinician chooses to opt-in in accordance with Sec. 414.1310,
the third party intermediary must be able to transmit that decision to
CMS.
(2) Certification
We previously finalized in the CY 2018 Quality Payment Program
final rule (82 FR 53807) at Sec. 414.1400(a)(5), that all data
submitted to us by a third party intermediary on behalf of a MIPS
eligible clinician, group or virtual group must be certified by the
third party intermediary to the best of its knowledge as true,
accurate, and complete; and that this certification must occur at the
time of the submission and accompany the submission. We have discovered
it is not operationally feasible to require certification at the time
of submission, or to require that the certification accompany the
submission, for submission types by third party intermediaries,
including data via direct, login and upload, login and attest, CMS Web
Interface or Medicare Part B claims. We refer readers to section
III.I.3.h.(1)(b) of this final rule for our proposed modifications to
the previously established data submission terminology. In order to
address these various submission types that are currently available, in
the CY 2019 PFS proposed rule (83 FR 35982), we proposed to amend Sec.
414.1400(a)(5) to state that all data submitted to CMS by a third party
intermediary must be certified as true, accurate, and complete to the
best of its knowledge and that such certification must be made in a
form and manner and at such time as specified by CMS.
We did not receive any public comments on our proposed amendments
to the certification requirement imposed on third party intermediaries.
We are finalizing our proposal, as proposed, at Sec.
414.1400(a)(5) to state that all data submitted to CMS by a third party
intermediary on behalf of a MIPS eligible clinician, group or virtual
group must be certified by the third party intermediary as true,
accurate, and complete to the best of its knowledge, and that such
certification must be made in a form and manner and at such time as
specified by CMS.
(3) Qualified Clinical Data Registries (QCDRs)
We refer readers to the CY 2018 Quality Payment Program final rule
(82 FR 53807 through 53815) and Sec. 414.1400 for our previously
finalized policies regarding QCDRs. In the CY 2019 PFS proposed rule
(83 FR 35982 through 35984) we proposed to update the following: The
definition of QCDR, the self-nomination period for QCDRs, information
required for QCDRs at the time of self-nomination, and consideration of
criteria for approval of QCDR measures.
(a) Proposed Update to the Definition of a QCDR
In the CY 2017 Quality Payment Program final rule (81 FR 77363
through 77364) at Sec. 414.1305, we finalized the definition of a QCDR
to be a CMS-approved entity that has self-nominated and successfully
completed a qualification process to determine whether the entity may
collect medical or clinical data for the purpose of patient and disease
tracking to foster improvement in the quality of care provided to
patients.
As described in the CY 2019 PFS proposed rule (83 FR 35982), we
want to ensure that QCDRs that participate in MIPS have access to
clinical expertise in quality measurement and are able to provide and
demonstrate an understanding of the clinical medicine, evidence-based
gaps in care, and opportunities for improvement in the quality of care
delivered to patients and priorities that are important to MIPS
eligible clinicians. From our experiences with QCDRs to date, we have
discovered that certain entities with predominantly technical
backgrounds have limited understanding of medical quality metrics or
the process for developing quality measures are seeking approval as a
QCDR. A large number of entities that do not have the necessary
clinical expertise to foster quality improvement have self-nominated or
indicated their interest in becoming QCDRs. In reviewing previous QCDR
measure submissions during the self-nomination and QCDR measure review
and approval cycles in MIPS, we have observed that some entities were
developing QCDR measures without a complete understanding of measure
constructs (such as what is required of a composite measure or what it
means to risk-adjust), and in some instances, QCDRs were developing
QCDR measures in clinical areas in which they did not have expertise.
We are concerned that QCDR measures submitted by such entities for
approval have not undergone the same consensus development, scientific
rigor, and clinical assessment that is required for measure
development, compared to those QCDR measures that are developed by
specialty societies and other entities with clinical expertise.
We recognize the importance of these organizations' expertise
within the Quality Payment Program; however, do not believe that these
types of entities with the absence of clinical expertise in quality
measurement, meet the intent of QCDRs. We believe that with the
increasing interest in QCDRs and QCDR measure development, it is
important to ensure that QCDRs that participate in MIPS are first and
foremost in the business of improving the quality of care clinicians
provide to their patients through quality measurement and/or disease
tracking and have the clinical expertise to do so.
In the CY 2019 PFS proposed rule (83 FR 35982 through 35983), we
proposed beginning with the 2022 MIPS payment year, to amend Sec.
414.1305 to modify the definition of a QCDR to state that the approved
entity must have clinical expertise in medicine and quality measure
development. Specifically, a QCDR would be defined as an entity with
clinical expertise in medicine and in quality measurement development
that collects medical or clinical data on behalf of a MIPS eligible
clinician for the purpose of patient and disease tracking to foster
improvement in the quality of care provided to patients.

[[Page 59896]]

As described in the CY 2019 PFS proposed rule (83 FR 35983), under
Sec. 414.1400(b)(2)(ii), an entity that uses an external organization
for purposes of data collection, calculation, or transmission may meet
the definition of a QCDR as long as the entity has a signed, written
agreement that specifically details the relationship and
responsibilities of the entity with the external organization effective
as of September 1 the year prior to the year for which the entity seeks
to become a QCDR. Thus, we expect entities without clinical expertise
in medicine and quality measure development that want to become QCDRs
would collaborate or align with entities with such expertise in
accordance with Sec. 414.1400(b)(2)(ii).
As a part of the self-nomination process, we will look for entities
that have quality improvement, measure development, as well as clinical
expertise. We will also follow up with the entity via, for example,
email or teleconference, should we question whether or not the entity
meets our standards. Alternatively, such entities may seek to qualify
as another type of third party intermediary, such as a qualified
registry. Becoming a qualified registry does not require the level of
measure development expertise that is needed to be a QCDR that develops
measures.
The following is a summary of the public comments received on the
proposal to update the definition of a QCDR and our responses:
Comment: Many commenters supported the proposal to modify the
definition of a QCDR to limit approval to entities that have clinical
expertise in medicine and quality measure development. Several
commenters recommended CMS provide clarification on how such clinical
and quality measure development expertise will be evaluated, with one
commenter suggesting the definition of clinical expertise include
having a majority-led physician Board of Directors or governing body
and that expertise in clinical measure development include demonstrated
QCDR measure development processes that take into account the CMS
Blueprint for measure development and maintenance activities. A few
commenters stated that CMS should establish processes for denying
applications and/or measures that appear to not have had any clinical
influence rather than requiring the entire entity to have ``expertise''
and provide a definition of what constitutes ``clinical expertise in
medicine and quality measure development.''
Response: We appreciate the commenters' support to update the
definition of a QCDR, limiting approval to entities that have clinical
expertise in medicine and quality measure development. Specifically, we
proposed that a QCDR would be defined as an entity with clinical
expertise in medicine and in quality measurement development that
collects medical or clinical data on behalf of a MIPS eligible
clinician for the purpose of patient and disease tracking to foster
improvement in the quality of care provided to patients. We appreciate
the commenters' suggestion that CMS provide more clarification on how
such clinical and quality measure development expertise will be
evaluated. For example, while not exhaustive, some aspects that may be
considered during our evaluation are a QCDR's: Previous measure
development experience (serving on an NQF TEP, for example); experience
with the measure development Blueprint process, which can be found at
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Blueprint-130.pdf; ability to create and use
multi-strata and composite measures where appropriate; ability to risk
adjust its own QCDR outcomes measures; technical expertise to run a
registry; and ability to reliably collect, retain, aggregate,
disseminate, and analyze data from their clinicians. We appreciate the
commenter's suggestion to include having a majority-led physician Board
of Directors or governing body, but we do not mandate that the QCDR be
led by a majority of physicians. We do consider clinical expertise and
experience in QCDR measure development and maintenance important, as
shown in our updated definition of a QCDR.
Comment: One commenter expressed concern regarding how CMS will
allow technical entities to partner with an external organization to
gain clinical expertise, citing its opinion that doing so would render
the policy ineffective if this enables technical entities to bypass
this requirement too easily. Another commenter stated that neither
small nor large EHR vendors should be allowed to enter the QCDR space
due to the former potentially collecting skewed data related to certain
practice arrangements and patient populations and the latter
potentially lacking the perspective of care improvement in medical
specialties.
Response: We disagree that allowing technical entities to partner
with an external organization to gain clinical expertise would render
the policy ineffective. The policy is intended to include entities that
are able to meet the definition, whether that be by a partnership with
a clinical entity, or on their own. In addition, we disagree that
neither small nor large EHR vendors should be allowed to collaborate to
become a QCDR. As stated in the proposed rule, entities without
clinical expertise in medicine and quality measure development, such as
small or large EHR vendors, may collaborate or align with entities with
such expertise in accordance with Sec. 414.1400(b)(2)(ii). In general,
we do not believe that Health IT vendors, including EHR vendors, alone
have the necessary clinical expertise. Having the option to collaborate
could alleviate the likelihood of skewed data or the absence of
perspective regarding care improvement in medical specialties, because
a collaboration with a clinical organization would provide knowledge of
patient populations, practice arrangements, and care improvement.
Comment: A few commenters disagreed with the proposed update to the
definition of a QCDR, citing their beliefs that the updated definition
is contrary to the promotion of the benefits of technology; will impose
artificial barriers to entry into the market; dictate who can provide
services to physicians instead of letting the free market decide; and
discriminate against potential vendors because of a perceived advantage
at quality measurement based on education, experience, etc. The
commenters stated that CMS should only require QCDRs to collaborate
with specialty societies in the development of measures to ensure
validity, clinical relevance, and proper risk adjustment.
Response: We disagree that the modified definition of QCDR opposes
promoting the benefits of technology because there are many options
through which MIPS eligible clinicians can utilize different third-
party intermediaries to submit data, and this proposed change will not
impact the ability for MIPS eligible clinicians to use these
mechanisms. We also disagree that the modified definition of QCDR
imposes barriers into the market or discriminates against potential
vendors because we offer vendors with more of a technical background
the opportunity to partner with an organization with greater clinical
expertise in order to meet the new QCDR definition. The intent of the
modified definition is to promote useful measure development and to
emphasize that clinical expertise is critical in gaining useful
measures. Furthermore, we believe that updating the definition of a
QCDR will help organizations understand the criteria in which we
evaluate them against. We want to ensure that the vendors we approve to
participate as a QCDR are of

[[Page 59897]]

a higher standard and understand the clinical science based off which
they develop measures. It is important that QCDRs also understand how
to construct measures, the analytics, and are able to ensure the
measures are reliable and valid, not doing so may negatively impact the
clinician's reporting and final score. Health IT vendors and/or EHR
vendors should collaborate with clinical organizations such as
specialty societies for their experience not only in measure
development but for their clinical expertise as well.
Comment: Some commenters stated that CMS should develop a process
by which a clinician who believes they are unsupported by a QCDR can
submit information to CMS for further investigation.
Response: If an eligible clinician would like to bring information
to CMS' attention regarding a QCDR being unsupportive as it pertains to
reporting issues, we suggest the clinician contact the Quality Payment
Program Service Center by emailing: [email protected].
Comment: One commenter noted that the proposed change may preclude
its continued approval by CMS as a QCDR because it does not dictate the
timeline in which specialty societies perform measure development and
without this approval, it would not be able to assist them in measure
development when necessary.
Response: Our updated definition of a QCDR would be effective
beginning with the 2022 MIPS payment year; and to clarify, we will not
be ``grandfathering'' in existing QCDRs who do not meet the updated
QCDR definition for the 2020 performance period. In coordination with
the finalization of the new QCDR definition and the publication of the
CY 2019 PFS final rule, we intend to notify existing QCDRs as to
whether they would meet the new QCDR definition or not based on
information submitted for a previous MIPS payment year.
Comment: A few commenters stated that CMS should finalize its
proposal for the 2019 performance year instead of the 2020 performance
year because removing non-clinician led vendors from the list of QCDRs
will not pose a significant burden on eligible clinicians or group
practices in 2019.
Response: While we appreciate commenters' support, we would like to
keep the effective timeframe of this policy (that is, the 2020
performance year) as proposed to provide existing QCDRs that would not
meet the updated QCDR definition with an appropriate amount of time to
comply or take other paths.
Comment: Many commenters who supported the proposal to update the
definition of a QCDR also provided recommendations including:
Development of a separate definition for QCDRs put forth by technology
companies to differentiate them from QCDRs managed by specialty
societies; requiring third-party entities that are not specialty
societies that would like to become QCDRs to collaborate with specialty
society QCDRs; and expansion of the definition of a QCDR to align with
the 21st Century Cures Act (especially with regard to entities being
clinician-led) or at minimum, revision of the definition to include
clinical expertise in medicine, quality improvement, and quality
measure/guideline development, as well as providing methods to ensure
data quality, routine metric reporting, and quality improvement
consultation.
Response: We do not agree that separate definitions are necessary
to differentiate between QCDRs, as the definition includes criteria set
for all QCDRs; or that the definition requires criteria as prescriptive
as entities being clinician-led. There are flexibilities in place, such
as collaboration with other entities such as large healthcare systems,
regional collaboratives, or specialty societies, in order for vendors
to meet the criteria in the definition. We believe we cover the areas
of clinical expertise, measure development, and quality improvement
work through this new definition. We believe that experience with data
quality and routine metric reporting is related to their measure
development experience and their registry experience, which is covered
by the new QCDR definition and the criteria of requiring that the
vendor must exist by January 1 of the performance period and have 25
participants submitting data to the QCDR (not necessarily for purposes
of MIPS).
After consideration of the public comments received, we are
finalizing our proposal to update the definition of a QCDR at Sec.
414.1305 beginning with the 2022 MIPS payment year, as proposed, to
state that a QCDR is an entity with clinical expertise in medicine and
in quality measurement development that collects medical or clinical
data on behalf of a MIPS eligible clinician for the purpose of patient
and disease tracking to foster improvement in the quality of care
provided to patients.
(b) Establishment of an Entity Seeking To Qualify as a QCDR
In the CY 2017 Quality Payment Program final rule (81 FR 77364), we
require at Sec. 414.1400(c)(2) that the QCDR must have at least 25
participants by January 1 of the performance period. These participants
do not need to use the QCDR to report MIPS data to us; rather, they
need to submit data to the QCDR for quality improvement. We realize
that a QCDR's lack of preparedness to accept data from MIPS eligible
clinicians and groups beginning on January 1 of the performance period
may negatively impact a clinician's ability to use a QCDR to report,
monitor the quality of care they provide to their patients (and act on
these results) and may inadvertently increase clinician burden. For
these reasons, we proposed to redesignate Sec. 414.1400(c)(2) as Sec.
414.1400(b)(2)(i) to state that beginning with the 2022 MIPS Payment
Year, the QCDR must have at least 25 participants by January 1 of the
year prior to the performance period (83 FR 35983). These participants
do not need to use the QCDR to report MIPS data to us; rather, they
need to submit data to the QCDR for quality improvement.
The following is a summary of the public comments received on the
``Establishment of an Entity Seeking To Qualify as a QCDR'' proposals
and our responses:
Comment: Many commenters disagreed with the proposal to require
QCDRs to have 25 participants by January 1 of the year prior to
performance period. Commenters noted it would place an undue burden on
QCDRs serving small specialties and inhibit the ability of new
registries to qualify as QCDRs, thus discouraging the use of QCDRs to
report MIPS data. One commenter suggested CMS work with stakeholders to
develop a timeline that is feasible and leads to properly functioning
QCDRs that can meet the goals of the MIPS program and the requirements
of the MACRA law. Another commenter stated that the existing
requirement is sufficient to ensure QCDR preparedness, while another
commenter stated that the threshold should be lowered or removed
completely, at least for those QCDRs that have already been in
operation and have lost participants when the low volume threshold
increased significantly.
Response: We disagree with commenters that this proposed policy
would cause undue burden or the ability of new entities to qualify as
QCDRs. To clarify, this requirement would demonstrate that the entity
has prior registry experience and the capability to accept, aggregate,
calculate, provide feedback to their participants on, retain, and
submit the data to CMS on the behalf of MIPS eligible clinicians. We
have previously experienced during

[[Page 59898]]

the past two performance periods that there have been instances of new
QCDRs that are not ready to accept data from eligible clinicians from
the start of the performance period due to operational issues within
the QCDR, including instances of QCDRs withdrawing during the
performance period because of reporting inexperience. We proposed this
requirement to ensure that organizations have this experience prior to
self-nomination. We continue to provide educational materials for QCDRs
on what is necessary to meet program criteria and requirements. We
clarify that the requirement to have at least 25 participants by
January 1 of the year prior to performance period does not require that
the entity's prior registry experience be under MIPS or any other CMS
program or that the participants be MIPS eligible clinicians. With
increasing stakeholder interest in the use of third-party
intermediaries to report for MIPS, we believe the threshold of 25
participants is a reasonable thresholds for QCDRs to attain.
After consideration of the public comments received, we are
finalizing our proposal, as proposed, to redesignate Sec.
414.1400(c)(2) as Sec. 414.1400(b)(2)(i) to state that beginning with
the 2022 MIPS Payment Year, the QCDR must have at least 25 participants
by January 1 of the year prior to the applicable performance period.
(c) Self-Nomination Process
We refer readers to the CY 2018 Quality Payment Program final rule
(82 FR 53808 through 53813) for our previously established policies
regarding the simplified self-nomination process for existing QCDRs in
MIPS that are in good standing and web-based submission of self-
nomination forms. We did not propose any changes to those policies in
this final rule; however, in the CY 2019 PFS proposed rule (83 FR
35983), we proposed to update: (1) The self-nomination period; and (2)
information required at the time of self-nomination.
(i) Self-Nomination Period
Under Sec. 414.1400(b), QCDRs must self-nominate from September 1
of the year prior to the applicable performance period until November 1
of the same year and must, among other things, provide all information
requested by us at the time of self-nomination. As indicated in the CY
2017 Quality Payment Program final rule (81 FR 77366), our goal has
been to publish the list of approved QCDRs along with their approved
QCDR measures prior to the beginning of the applicable performance
period.
We have received feedback from entities that have self-nominated to
be a QCDR about the need for additional time to respond to requests for
information during the review process, particularly with respect to
QCDR measures that the entity intends to submit to us for the
applicable performance period. In addition, based on our observations
of the previous two self-nomination cycles, we anticipate an increase
in the number of QCDR measure submissions for our review and
consideration. For the transition year of MIPS, we received over 1,000
QCDR measure submissions for review, and for the CY 2018 performance
period, we received over 1,400 QCDR measure submissions. In order for
us to process, review, and approve the QCDR measure submissions and
provide QCDRs with sufficient time to respond to requests for
information during the review process, while still meeting our goal to
publish the list of approved QCDRs along with their approved QCDR
measures prior to the start of the applicable performance period, we
believe that an earlier self-nomination period is needed.
Therefore, in the CY 2019 PFS proposed rule (83 FR 35983), we
proposed to update the self-nomination period from September 1 of the
year prior to the applicable performance period until November 1 to
July 1 of the calendar year prior to the applicable performance period
until September 1. Therefore, in the CY 2019 PFS proposed rule (83 FR
35983), we also proposed to amend Sec. 414.1400(b)(1) to provide that,
beginning with the 2022 MIPS payment year, entities seeking to qualify
as QCDRs must self-nominate during a 60-day period beginning on July 1
of the calendar year prior to the applicable performance period and
ending on September 1 of the same year; must provide all information
required by us at the time of self-nomination; and must provide any
additional information requested by us during the review process. For
example, for the 2022 MIPS payment year, the applicable performance
period would be CY 2020, as discussed in section III.I.3.g. of this
final rule. Therefore for the CY 2020 performance period, the self-
nomination period would begin on July 1st, 2019 and end on September
1st, 2019, and we will make QCDRs aware of this through our normal
communication channels. We believe that updating the self-nomination
period would allow for additional review time and measure discussions
with QCDRs.
We refer readers to section III.I.3.k.(3)(c)(ii) of this final rule
for a summary of the public comments received on these proposals and
our responses.
(ii) Information Required at the Time of Self-Nomination
We refer readers to the CY 2018 Quality Payment Program final rule
(82 FR 53814), where we finalized that as a part of the self-nomination
review and approval process for the CY 2018 performance period and
future years, we will assign QCDR measure IDs to approved QCDR
measures, and the same measure ID must be used by any other QCDRs that
have received permission to also report the measure. We have received
some questions from stakeholders as to whether the QCDR measure ID must
be utilized or whether it is optional. As stated in the CY 2018 Quality
Payment Program final rule, QCDRs, including any other QCDRs that have
received permission to also report the measure, must use the CMS-
assigned QDCR measure ID. It is important that the CMS-assigned QCDR
measure ID is posted and used accordingly, because without this ID we
are not able to accurately identify and calculate the QCDR measures
according to their specifications. Therefore, in the CY 2019 PFS
proposed rule (83 FR 35983), we proposed to update Sec.
414.1400(b)(3)(iii) to state that QCDRs must include their CMS-assigned
QCDR measure ID number when posting their approved QCDR measure
specifications, and also when submitting data on the QCDR measures to
us.
The following is a summary of the public comments received on the
``Self-Nomination Process'' proposals and our responses:
Comment: Several commenters noted they would support the proposed
change to the self-nomination timeline if CMS would adopt multi-year
approval of QCDRs as they noted doing so would reduce burden, alleviate
a shortened nomination timeline, potentially strengthen the measure
development process in future years, encourage uptake of new measures,
allow for uninterrupted data collection, and allow for more consistent
and robust data collection and benchmarking.
Response: In the CY 2018 Quality Payment Program final rule (82 FR
53808), we discussed our concerns with multi-year approval and sought
comment from stakeholders as to how to mitigate our concerns. Moreover,
a multi-year approval process would not take into consideration
potential changes in criteria or requirements of participation for
QCDRs that may occur

[[Page 59899]]

as the MIPS program develops through future program years. We did not
receive any suggestions or responses from stakeholders that would
alleviate our concerns with adopting this policy. Therefore, we
continue to believe multi-year approval of QCDRs is inappropriate at
this time.
Comment: One commenter stated that in order to encourage QCDRs to
continue seeking QCDR status, CMS should work with specialty-led QCDR
stewards to further improve the self-nomination process and ensure a
viable and private sector-run reporting option to alleviate burden and
increase evidence-based decisions.
Response: We value stakeholder input and conduct process
improvement on an ongoing basis. We will continue to seek opportunities
to receive input throughout the year.
Comment: Many commenters disagreed with the proposal to change the
QCDR self-nomination period, citing their beliefs that maintaining the
September 1 through November 1 self-nomination period without change is
necessary to minimize additional burden and constraints on QCDRs;
provide QCDRs the time to prepare data to support measures in the
application process; provide QCDRs an opportunity to gain insight into
recent policy changes; and negate potentially adverse impacts to the
life cycle of QCDRs, the maintenance process for existing QCDR
measures, and/or development of new measures. One commenter stated that
due to additional data being required as part of the self-nomination
process, the revised self-nomination period would be more difficult.
Another commenter suggested the change should not be implemented until
the CY 2021 performance period and noted QCDR approval will need to
expand beyond 12 months to avoid a scenario where a QCDR is only
approved for a few months before they must go through the self-
nomination process again. Finally, another commenter suggested the
self-nomination period be extended to 90 days due to its belief that
the 60-day period is excessively challenging and burdensome in terms of
the information required and additional requests to which QCDRs must be
respond.
Response: As described in the CY 2019 PFS proposed rule (83 FR
35983), we have heard from QCDRs that they need additional time to
respond to our requests for additional information during the QCDR
measure review process, as well as requests for feedback or measure
harmonization across QCDRs in a more extensive manner that would not be
feasible with the current timeline. We believe with sufficient notice,
providing stakeholders with educational material, and the
implementation of the simplified self-nomination process we are
minimalizing additional burden on QCDRs. Through the publication of
self-nomination reference material prior to the self-nomination period,
as we have done for the 2019 self-nomination period, we intend on
giving QCDRs the utmost resources and support as they prepare to self-
nominate prior to the closing of the self-nomination period. We plan to
post self-nomination material prior to the start of the self-nomination
period in July, thereby giving stakeholders' time to prepare the
necessary materials needed, inclusive of the additional information
requested as a part of the self-nomination process. As we develop QCDR
and qualified registry related policies for future rulemaking, we will
factor in how the proposals impact an entity's ability to self-nominate
and participate in the program prior to deciding what year to implement
the policies for. We do not believe that delaying the finalization of
this proposal until the 2021 performance period of MIPS would benefit
the QCDRs, as we have previously explained, QCDR self-nomination must
occur on an annual basis to take into consideration policy,
participation requirement, and considerations to a QCDR or registry's
standing (if they are on probation or have been precluded).
We believe the benefits of moving up the self-nomination period to
allow for additional time and discussion of QCDR measures is beneficial
for both QCDRs and CMS. We disagree that the self-nomination period
needs to be extended to a 90-day period, we believe with the resource
materials provided, as well as us offering to meet with QCDRs prior to
self-nomination to discuss their QCDR measures and receive preliminary
feedback, QCDRs have the ability to better prepare for the self-
nomination period.
Comment: A few commenters supported the proposal to update the QCDR
self-nomination timeline. One commenter stated that CMS should use the
updated nomination period to facilitate additional discussion with
QCDRs regarding measure development. Another commenter stated that CMS
should change its expectations for providing data for measures
accordingly and allow a transition year to lessen the impact on the
measure development life cycle and maintenance of existing measures.
Response: We agree that this change in the self-nomination period
will allow for additional conversations on measure development and QCDR
measure feedback. We disagree with the implementation of a transition
year, considering that on annual basis we must review performance data
to evaluate whether the measure demonstrates a gap in performance or
whether the measure demonstrates topped out performance where no
meaningful measurement can be obtained. As previously mentioned, QCDR
measures do not have to go through the NQF's Measures Application
Partnership (MAP) committee prior to implementing them in MIPS. If a
QCDR is unable to provide performance data reflecting a gap, the QCDR
may provide for our consideration citations to recent studies or
clinical journals that demonstrate a need for measurement.
Comment: One commenter suggested CMS provide a definition of
``minimal changes'' regarding the QCDR self-nomination process as well
as specifications around data requests to support QCDR measures.
Response: In the CY 2018 Quality Payment Program final rule (82 FR
53811), we stated that minimal changes include, but are not limited to:
Limited changes to performance categories, adding or removing MIPS
quality measures, and adding or updating existing services and/or cost
information. Additional educational resources are available in the QPP
resource library at https://qpp.cms. gov/.
Comment: One commenter recommended changes to the QCDR self-
nomination process, including updating QCDR self-nomination application
and materials to outline all of the information needed to determine
QCDR status to avoid delays and misunderstandings and providing at
least a 60-day notice of any changes to the QCDR vetting process,
including review of measures and a minimum of 30 days to appeal
changes. The commenter further stated that changes to the 2019 QCDR
application requirements should not be made until after the final rule
is released due to the current QCDR application timeline closing on
November 1 coinciding with publication of the final rule and that since
the majority of specialty QCDRs stewards are currently submitting QCDR
applications, CMS should allow these QCDRs to fully comment on these
new proposed standards to which they are being held and which they may
not support. Alternatively, the commenter suggested CMS allow for a
nimble 2019 QCDR application process, including changes to the
licensing standards given

[[Page 59900]]

the significant changes CMS proposes for 2019.
Response: To clarify, we proposed that the self-nomination period
be moved for the 2020 performance period, not the 2019 performance
period as indicated by the commenter, to allow for sufficient time and
notice of the changes. We will continue to provide educational
materials that will outline all of the information needed to evaluate a
QCDR's ability to meet participation standards and QCDR measure
evaluation criteria prior to the start of the self-nomination period.
With the publication of this final rule, we intend on communicating any
changes to the review process. For the 2019 performance period, it is
not feasible to allow for a minimum of 30 days to appeal changes due to
our goal of approving and publicizing the QCDRs by the start of the
performance period. By moving up the self-nomination period, we will be
able to allow QCDRs to have more time to consider our QCDR measure
feedback. Additionally, moving the timeline to earlier in the year will
allow CMS to review the measures fully and provide feedback to the QCDR
who submitted the measures. The earlier self-nomination will also allow
QCDRs who submit clinically similar measures to another QCDR and whose
measure(s) are rejected to reach out to the QCDR whose measures are
approved to attempt to enter into a licensing use agreement with the
QCDR with the approved measures if desired. It is the goal of CMS to
post the most comprehensive list of approved QCDRs and their measures
before the start of the performance period so that eligible clinicians
intending to use a QCDR can review these materials and select the QCDR
that best meets their needs. In this way, the eligible clinician may
begin submitting data to the QCDR at the start of the performance
period. By doing so, the clinician will be more likely to receive
timely feedback from the QCDR regarding his/her performance (earlier in
the year) which will allow for quality improvement to occur during the
performance period instead of receiving this data later in the year or
after the conclusion of the performance period.
The CY 2019 performance period self-nomination form reflects the
proposed MIPS quality measures, Promoting Interoperability measures,
and Improvement Activities as proposed in the CY 2019 PFS proposed
rule. We include disclaimer language that indicates that measures and
activity availability are subject to change, pending upon what is
finalized in the final rule. We continuously take into consideration
stakeholder feedback as we look into process improvements and policy
development for future program years. We appreciate the commenters'
suggestions, and ask that they provide more detail as to the changes to
the licensing standards that they recommend we implement for future
consideration.
After consideration of the public comments received, we are
finalizing our proposal to amend Sec. 414.1400(b)(1) to provide that,
beginning with the 2022 MIPS payment year, entities seeking to qualify
as QCDRs must self-nominate during a 60-day period beginning on July 1
of the calendar year prior to the applicable performance period and
ending on September 1 of the same year; must provide all information
required by us at the time of self-nomination; and must provide any
additional information requested by us during the review process. In
addition, we are finalizing our proposal to update Sec.
414.1400(b)(3)(iii) to state that QCDRs must include their CMS-assigned
QCDR measure ID number when posting their approved QCDR measure
specifications, and also when submitting data on the QCDR measures to
us.
(d) QCDR Measure Requirements
We refer readers to the CY 2017 Quality Payment Program final rule
(81 FR 77374 through 77375) for where we previously finalized standards
and criteria used for selecting and approving QCDR measures. We
finalized that QCDR measures must: Provide specifications for each
measure, activity, or objective the QCDR intends to submit to CMS; and
provide CMS descriptions and narrative specifications for each measure,
activity, or objective no later than November 1 of the applicable
performance period for which the QCDR wishes to submit quality measures
or other performance category (improvement activities and Promoting
Interoperability) data starting with the 2018 performance period and in
future program years. In the CY 2019 PFS proposed rule (83 FR 35983),
we proposed to consolidate our previously finalized standards and
criteria used for selecting and approving QCDR measures at Sec.
414.1400(e) and (f) at Sec. 414.1400(b)(3). We also proposed to apply
certain criteria used under the Call for Quality Measures Process when
considering QCDR measures for possible inclusion in MIPS beginning with
the MIPS 2021 payment year (83 FR 35983).
In the CY 2018 Quality Payment Program final rule (82 FR 53814), we
noted our interest in elevating the standards for which QCDR measures
are selected and approved for use and sought comment on whether the
standards and criteria used for selecting and approving QCDR measures
should be more closely aligned with those used for the Call for Quality
Measures process described in the CY 2017 Quality Payment Program final
rule (81 FR 77151). Some commenters expressed concern with this
alignment, stating that the Call for Measures process is cumbersome,
and would increase burden. Other commenters expressed the belief that
the Call for Measures process does not recognize the uniqueness of
QCDRs, and is not agile. We would like to clarify that our intention
with any future alignment is to work towards consistent standards and
evaluation criteria that would be applicable to all MIPS quality
measures, including QCDR measures. We understand that some of the
criteria under the Call for Measures process may be difficult for QCDRs
to meet prior to submitting a particular measure for approval; however,
we believe that the criteria under the Call for Measures process helps
ensure that any new measures are reliable and valid for use in the
program. Having a greater alignment in measure standards helps ensure
that MIPS eligible clinicians and groups are able to select from an
array of measures that are considered to be higher quality and provide
meaningful measurement. As such, we believe that as we gain additional
experience with QCDRs in MIPS, it would be appropriate to further align
these criteria for QCDR measures with those of MIPS quality measures in
future program years.
Therefore, in addition to the QCDR measure criteria previously
finalized at Sec. 414.1400(f), we proposed in the CY 2019 PFS proposed
rule (83 FR 35984) to apply select criteria used under the Call for
Measures Process, as described in the CY 2018 Quality Payment Program
final rule (82 FR 53636). Specifically, in addition to the QCDR measure
criteria at proposed Sec. 414.1400(b)(3), we proposed in the CY 2019
PFS proposed rule (83 FR 35984) to apply the following criteria
beginning with the 2021 MIPS payment year when considering QCDR
measures for possible inclusion in MIPS:
Measures that are beyond the measure concept phase of
development.
Preference given to measures that are outcome-based rather
than clinical process measures.
Measures that address patient safety and adverse events.
Measures that identify appropriate use of diagnosis and
therapeutics.
Measures that address the domain for care coordination.

[[Page 59901]]

Measures that address the domain for patient and caregiver
experience.
Measures that address efficiency, cost and resource use.
Measures that address significant variation in
performance.
We believe that as we gain additional experience with QCDRs in
MIPS, it would be appropriate to further align these criteria for QCDR
measures with those of MIPS quality measures in future program years.
Specifically, we are considering proposing to require reliability and
feasibility testing as an added criteria in order for a QCDR measure to
be considered for MIPS in future rulemaking.
In addition, we refer readers to the CMS Quality Measure
Development Plan at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/Final-MDP.pdf for more information regarding the measure
development process.
The following is a summary of the public comments received on the
``QCDR Measure Requirements'' proposals and our responses:
Comment: A few commenters stated that CMS should offer multi-year
approval of QCDR measures to maximize stability and predictability
while minimizing redundancy. The commenters further stated that QCDRs
should be allowed to make minor modifications to measures under this
multi-year approval process based on updated guidelines, evidence, or
measure methodologies and if QCDR measures were approved for 2 to 3
years, the earlier self-nomination deadline would not be as problematic
for registry vendors and would streamline CMS' process.
Response: We disagree that offering multi-year approval of QCDR
measures would minimize redundancy, as this may actually lead to
duplicative measures which is counter intuitive to our meaningful
measures initiative. Multi-year approvals of QCDR measures does not
account for the possibility of there being more robust QCDR measures of
similar concepts being submitted for CMS consideration. We may consider
a similar process for future years, which is used with MIPS quality
measures, where we'd continue to evaluate all the measures on an annual
basis and compare them to those submitted during the measure
consideration period (self-nomination period) to determine what QCDR
measures would be best to include for the upcoming performance period.
QCDRs making changes to their measures would have to self-nominate
those changes for CMS' approval, and if we receive measures of similar
concept that are more robust they may be considered to replace the
existing approved QCDR measures.
Comment: One commenter supported the proposal to include the CMS-
assigned QCDR measure ID number when posting the approved QCDR measure
specifications, and also when submitting data on the QCDR measures to
CMS.
Response: We appreciate the commenter's support.
Comment: One commenter stated that CMS should not approve highly
duplicative measure concepts submitted at a later time as doing so
increases confusion among physicians and competition among QCDRs while
disregarding the time, resources, and intellectual property rights of
the measure owners. Some commenters noted that measures are misaligned,
overlapping and duplicative across QCDR and MIPS measures.
Response: We agree that duplicative measures are counterintuitive
to the Meaningful Measures initiative that promotes more focused
quality measure development towards outcomes that are meaningful to
patients, families and their providers. It is our intent to move toward
measure harmonization, which supports our efforts to increase measure
alignment and eliminate redundancy both within the MIPS measure set and
across CMS programs.
Comment: A few commenters supported the proposal to update QCDR
measure criteria and encouraged CMS to have dialogue with QCDRs
regarding the submission of measures. One commenter stated that CMS
should expand the policy toward having a common national framework for
endorsement of measures by a national consensus body (which currently
is the National Quality Forum) and set expectations when accepting QCDR
measures that measure stewards would be expected to get endorsement
after a certain defined time period.
Response: We will continue dialogue with QCDRs during our scheduled
calls. As far as expanding our policy toward having a common national
framework for endorsement of measures by a national consensus body, we
agree this would be valuable and encourage QCDRs to have their measures
NQF endorsed. However, it is not a necessary requirement at this time
because of its potential increase in burden and potential unintended
impacts on the ability of QCDRs to adapt their measures.
Comment: A few commenters stated that CMS should work with both
specialty societies and vendors in facilitating the time and effort
needed to successfully encourage reporting of specialty-specific
process and outcome measures while ensuring proper review and that
appropriate data can be collected and shared. One commenter suggested
CMS develop a review process where CMS and its contractor consult with
appropriate physician experts and QCDR stewards to ensure sufficient
clinical expert review on the importance and relevancy of a measure.
Response: We hold QCDR measure preview calls to provide a forum to
work with both specialty societies and vendors wishing to self-nominate
QCDR measures. New entities wishing to review QCDR measure concepts
with CMS, may request a meeting with CMS by contacting the Quality
Payment Program Service Center at [email protected]. Existing QCDRs may
contact our contractor support team to set up a QCDR measure preview
call. We have several measure experts as part of our review process,
many of which have specialty specific expertise. Furthermore, we hold
calls prior to self-nomination to allow experts to discuss their QCDR
measure concepts, and will also continue to schedule calls with QCDRs
after the self-nomination period closes to provide feedback, which
provides time for QCDRs to invite their clinical experts to provide
additional information and explanation that would provide us with
clarifications that may lead to a QCDR measure reexamination.
Comment: Many commenters did not support the proposal to align QCDR
measure requirements with the criteria used under the Call for Quality
Measures Process due to their beliefs that applying this criteria to
QCDR measures fails to recognize the unique role of QCDRs who fill
critical gaps in traditional quality measure sets as they support
different specialties, and that doing so would limit the number of
measures available for QCDR participants, would create more stringent
standards for QCDR measures resulting in additional burden, and be
counterproductive toward the goal of encouraging the use of QCDRs.
Commenters stated that rather than require these criteria, the criteria
should be made optional, but strongly preferred, as there are existing
evidence-based process measures that are still valuable to improving
patient care and should still be considered for inclusion in the QCDR
program; and that since some outcome measures which evaluate
degenerative or rare incidences, conditions that are terminal with
limited treatment options, or conditions which result in increased co-
morbidities require measurement over the course of multiple years to
have sufficient

[[Page 59902]]

statistical power, CMS should continue the use of certain process
measures until they can be easily converted to meaningful outcome
measures.
Response: We believe that our process seeks to ensure reliable
measures and expect all measures in the program, including QCDRs, to be
held to that standard. We believe that it is imperative to raise the
bar with QCDR measures in order to ensure that we move away from
standard of care, low-bar, process, and/or duplicative measures.
Specifically, we are considering proposing to require reliability and
feasibility testing as an added criteria in order for a QCDR measure to
be considered for MIPS in future rulemaking. In the CY 2018 Quality
Payment Program final rule (82 FR 53814), we state that as the MIPS
program progresses in its implementation, we are interested in
elevating the standards for which QCDR measures are selected and
approved for use. As a part of our QCDR measure review process, we do
consider the complexity of what is being measured, while being mindful
that measures with high performance do not provide value with regards
to the quality performance category in MIPS. There are process measures
in MIPS that are considered high priority, we believe it is important
to retain those so long as they demonstrate room for improvement and
lead to meaningful outcomes.
Comment: One commenter suggested CMS clarify the process by which a
measure would be assigned within the domains provided under the
proposed alignment with the Call for Quality Measures process and offer
greater transparency in the rationale for this assignment or outcome
status. In addition, the commenter recommended that CMS defer to the
rationale and status identified by the QCDR, in particular for
clinician-led registries.
Response: During the self-nomination process, we ask the QCDR to
assign their QCDR measure a NQS domain, Meaningful Measure Area,
whether or not their measure is high priority and/or an outcome
measure. As a part of the vetting process, we review those selections
and will reach out to the QCDR should we not agree with their
assignment.
Comment: One commenter stated that due to the announcement of
approved measures continuing to occur on a fixed schedule shortly
before the start of each MIPS performance period despite the rolling
submission process for new MIPS measures through the Call for Quality
Measures Process, CMS should transition to a rolling review and
approval process for QCDR measures to allow stakeholders more time to
implement new measures prior to the MIPS performance period. This
commenter also stated that if CMS is unwilling to move to a rolling
review and approval process, the quality category performance period
should be reduced. The commenter noted that the rolling submission
process has not benefited measure owners, QCDRs, registries, and EHR
vendors, all of which have very little time to modify their systems to
include new measures post-approval and prior to the start of the next
MIPS performance period.
Response: We note that a rolling review basis would adversely
impact our ability to limit the number of duplicative measures that are
similar in concept, which is inconsistent with the meaningful measure
initiative. We believe that the change in the self-nomination period
would allow for increased time in the measure review process, as well
as provide additional time for QCDRs to respond to feedback provided by
CMS. We do not believe a rolling review and approval process is
appropriate, as it is not a process that is used for MIPS quality
measures. We do not agree that the quality performance period should be
reduced dependent on whether or not a rolling review and approval
process is implemented as there is no correlation between the two
processes.
Comment: One commenter suggested CMS should require measure
developers to include a section in each measure that specifies how
eligible clinicians and TINs should be attributed for that measure to
assist in preventing different interpretations for measure attribution
which could lead to TIN/NPI mismatches and resulting determinations by
CMS that submitted data is inaccurate.
Response: We agree that attribution should be clearly stated in the
QCDR measure specifications and appreciate the commenter's feedback. We
will take this suggestion into consideration as we review QCDR measure
concepts, and will share this feedback with the QCDRs for their
consideration.
After consideration of the public comments received, we are
finalizing our proposal to consolidate our previously finalized
standards and criteria used for selecting and approving QCDR measures
at Sec. 414.1400(e) and (f) at Sec. 414.1400(b)(3) and to apply
certain criteria used under the Call for Quality Measures Process when
considering QCDR measures for possible inclusion in MIPS beginning with
the MIPS 2021 payment year. We are also finalizing our proposal to
apply select criteria used under the Call for Measures Process, as
described in the CY 2018 Quality Payment Program final rule (82 FR
53636) in addition to the QCDR measure criteria previously finalized at
Sec. 414.1400(f). Specifically, in addition to the QCDR measure
criteria that we are finalizing at Sec. 414.1400(b)(3), we are also
finalizing our proposal to apply the following criteria beginning with
the 2021 MIPS payment year when considering QCDR measures for possible
inclusion in MIPS:
Measures that are beyond the measure concept phase of
development.
Preference given to measures that are outcome-based rather
than clinical process measures.
Measures that address patient safety and adverse events.
Measures that identify appropriate use of diagnosis and
therapeutics.
Measures that address the domain for care coordination.
Measures that address the domain for patient and caregiver
experience.
Measures that address efficiency, cost and resource use.
Measures that address significant variation in
performance.
(e) QCDRs Seeking Permission From Another QCDR To Use an Existing,
Approved QCDR Measure
In the CY 2018 Quality Payment Program final rule (82 FR 53813), we
finalized that beginning with the 2018 performance period and for
future program years, QCDR vendors may seek permission from another
QCDR to use an existing measure that is owned by the other QCDR. We
intended for this policy to help reduce the number of QCDR measures
that are similar in concept or clinical topic, or duplicative of other
QCDR measures that are being approved. Furthermore, having multiple
QCDRs report on the same QCDR measure allows for a larger cohort of
clinicians to report on the measure, which helps establish more
reliable benchmarks and may give some eligible clinicians or group a
better chance of obtaining a higher score on a particular measure.
However, we have experienced that this policy has created unintended
financial burden for QCDRs requesting permission from other QCDRs who
own QCDR measures, as some QCDRs charge a fee for the use of their QCDR
measures. MIPS quality measures, while stewarded by specific specialty
societies or organizations, are generally available for third party
intermediaries, MIPS eligible clinicians, and groups to report on for
purposes of MIPS without a fee for use. Similarly, we believe, that
once a QCDR measure is approved for reporting in MIPS, it should be
generally available for other

[[Page 59903]]

QCDRs to report on for purposes of MIPS without a fee for use. In the
CY 2019 PFS proposed rule (83 FR 35984), we proposed at Sec.
414.1400(b)(3)(ii)(C) that beginning with the 2021 MIPS payment year,
as a condition of a QCDR measure's approval for purposes of MIPS, the
QCDR measure owner would be required to agree to enter into a license
agreement with CMS permitting any approved QCDR to submit data on the
QCDR measure (without modification) for purposes of MIPS and each
applicable MIPS payment year. In the CY 2019 PFS proposed rule (83 FR
35984) we also proposed at Sec. 414.1400(b)(3)(iii) that other QCDRs
would be required to use the same CMS-assigned QCDR measure ID. If a
QCDR refuses to enter into such a license agreement, the QCDR measure
would be rejected and another QCDR measure of similar clinical concept
or topic may be approved in its place.
The following is a summary of the public comments received on the
``QCDRs Seeking Permission from another QCDR to Use an Existing,
Approved QCDR Measure'' proposals and our responses:
Comment: Many commenters disagreed with CMS' proposal to require
QCDRs to enter into a measure licensing agreement with CMS beginning
with the 2021 MIPS payment year, stating that QCDRs would be required
to attest to these measures before knowledge that this proposal would
be finalized and that they, therefore, did not know that they would be
required to enter into mandatory licensing agreements for these
measures at the time of attestation. Commenters specifically stated
that this timeline would violate the Administrative Procedure Act.
Other commenters stated that should the proposal be finalized, it would
be unreasonable for QCDR measure stewards to implement the policy by
January 1 of the 2019 performance period given that the self-nomination
period closes prior to publication of the CY 2019 PFS final rule.
Commenters stated that the proposal, if it is finalized, should be
delayed at least 1 year to give QCDRs an opportunity to decide whether
to continue participating in the program. One commenter stated that
some specialty societies may delay their QCDR application until this
issue has been addressed by CMS.
Response: Based on the feedback and concerns raised by
stakeholders, in the interim, we are not finalizing this proposal.
Rather, while we believe our proposal is consistent with the
Administrative Procedure Act, we are persuaded by the other concerns
raised by stakeholders on the implementation of this policy and are
therefore retaining our existing policy that QCDR vendors may seek
permission from another QCDR to use an existing measure that is owned
by the other QCDR (82 FR 53813).
Comment: Many commenters disagreed with the proposal to require
QCDR measure owners to allow other QCDRs to submit data on the QCDR
measure as a condition of measure approval. Reasons cited for
disagreeing with the proposal include beliefs that it does not
acknowledge the cost in developing complex measures; would unfairly
reduce costs for QCDRs that do not develop their own measures while
increasing costs for QCDRs that do; would compromise the intellectual
property of measure stewards as CMS would have a mandatory, exclusive,
and unfettered right to sublicense their QCDR measures for MIPS
purposes as a condition of measure approval; would undermine the smooth
operation of the QCDR measure market; is an arbitrary and capricious
reversal of existing policy; violates intellectual property law,
judicial precedent, executive order, and copyrights; nullifies the
rights of copyright owners to collect reasonable royalties, maintain
measure integrity, and limit inappropriate use; might remove the right
of QCDR developers to have input into how CMS uses their measures; may
result in a developer having to seek CMS's approval prior to working
with another payer entity for reporting of its measures; and ignores
the time and resources spent in developing and maintaining measures.
Response: As noted above we are not finalizing this proposal. We
note that we do not believe this proposal would have violated
intellectual property rights or law, as QCDRs would not have been
required to submit QCDR measures for approval, and if a QCDR had
refused to enter into such a license agreement, the QCDR measure would
have been rejected and another QCDR measure of similar clinical concept
or topic may have been approved in its place. We will take the many
concerns raised by commenters into consideration as we work with
stakeholders to address this issue in the future.
Comment: Many commenters disagreed with the proposal to require
QCDR measure owners to allow other QCDRs to submit data on the QCDR
measure as a condition of measure approval believing it contradicts the
intent of the Meaningful Measure Initiative by eliminating the
incentive to develop innovative quality measures that focus on
meaningful outcomes; will disincentivize societies from investing in
the development of new and improved measures; may increase the
incidence of inappropriate use of measures by QCDRs lacking the
necessary clinical breadth of exposure/experience resulting in lower
quality data being collected, decreased reliability and validity of
results, and potential misclassification of providers; would negatively
impact the quality of available measures and physician community
support for the Quality Payment Program in general; would
disincentivize QCDRs from remaining in business, resulting in loss of
significant private sector knowledge and experience, as well as
increasing the financial burden on the government to hire more federal
contractors to replace lost innovation and creativity; and disregards
the original intent of QCDRs to submit data on non-MIPS measures
focused on disease, condition, procedure, or therapy-specific patient
populations.
Response: We do not believe this proposed policy contradicts the
Meaningful Measure Initiative, which seeks to reduce the number of
duplicative measures in quality performance programs, thereby reducing
clinician burden and complexity. However, as noted above we are not
finalizing this proposal. We also note that with the finalization of
the updated QCDR definition, we believe we will be able to negate any
concerns of inappropriate use of QCDR measures by QCDRs who do not have
the clinical expertise needed to understand the measure at hand. We
have observed increasing interest in stakeholders becoming QCDRs, and
believe that they will continue to drive innovation and competition
within the market.
Comment: A few commenters suggested alternatives to the proposal to
require QCDRs to license their measures to CMS. These alternatives
include encourage licensing agreements between QCDRs and reinforcing
the ability of QCDRs to develop their own measures should they elect
not to license them from other QCDRs. One commenter suggested that CMS
should create a ``measure complexity score'' with a corresponding,
volume-based, licensing fee payable to the QCDR holding the original
measure in conjunction with an annual consolidation of measures to
support harmonization requiring stakeholders to collaborate on a
``shared'' measure creation (with licensing fees split evenly) or lose
the opportunity for future licensing fee payments. Another commenter
recommended CMS propose including a cost-based algorithm that would be
used to determine a specific QCDR measure fee which would protect
organizations

[[Page 59904]]

that could not afford the development of a quality measure or that were
not able to develop a measure because a similar measure exists, as well
as preventing QCDR measure developers from assigning unreasonable fees
to their measures. One commenter recommended CMS establish a pilot
program that would encourage collaboration across QCDRs and require
users of QCDR measures to agree to adhere to certain requirements of
the measure steward, as well as share measure performance information
to implement and test measure changes, progressing all concepts to
patient-centered outcome measures through measure retirement. Another
commenter recommended that CMS follow NQF's example that anyone can
report the measure scores and there has to be public/free access for
the measures to be used in clinical care, but the measure steward
should be permitted to require licensing and fees for anyone who wants
to use the measures for more sophisticated purposes, such as
programming into software that will result in sales/profit. Other
commenters cited their opinions that should the proposal be finalized,
it should be done with modification to require a standard data
dictionary be used for all QCDR measures and include risk adjustment as
well as the same standard methodology used by the measure developer.
Response: We note that the suggestion to encourage licensing
agreements between QCDRs was implemented in the CY 2018 Quality Payment
Program final rule (82 FR 53813 through 53814); however, we have
decided not to finalize the measure licensure policy at this time. Our
goal in enacting such a policy was to promote measure harmonization and
decrease the number of duplicative QCDR measures in the program. We
appreciate the suggestion of a ``measure complexity score'' but
envision such an approach would be difficult to implement. We would
need additional information from stakeholders prior to implementing
such a policy, such as how would CMS know how to correlate the volume
and complexity to a specific score? What would that entail if on an
annual basis the number of QCDRs who submit a similar measure concept
increases, and what would they have to do in order to be a part of the
harmonization effort? We request clarification on how a cost-based
algorithm can be developed, and would also like to clarify that CMS
does not regulate the minimum or maximum amounts that a QCDR may charge
as a licensing fee.
We thank the commenter for their suggestion of implementing a pilot
program where QCDRs would need to share measure performance
information, test and implement measure changes, and work towards
patient-centered outcome measures. We agree that the sharing of
performance data, testing results, and moving towards outcome based
measures are all important, but will need to look into the feasibility
and operations of implementing such requirements. With regards to the
development of a standard data dictionary, as described in the CY 2018
Quality Payment Program final rule (82 FR 53813), we encourage QCDR
measure developer to utilize the current Measure Development Plan
available at https://www.cms.gov/Medicare/Quality-Payment-Program/Measure-Development/2018-MDP-annual-report.PDF. Furthermore, as
explained through posted sub-regulatory documents for the 2019 self-
nomination period, the current Blueprint for the CMS Measures
Management System available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/BlueprintVer14.pdf. Both resources provide information on standardized
terminology, measure concepts and constructs.
Comment: Many commenters requested CMS work with them to adopt a
market-based solution to create safeguards to protect the proper
implementation of QCDR measures and enforce the intellectual property
rights of developers of QCDR measures, while also ensuring that the
measures are readily available to other QCDRs with clinical expertise
and experience in quality measure development.
Response: We will look to provide listening sessions to better
understand and explore the feasibility of this approach.
Comment: Many commenters expressed concern with CMS' requests for
harmonization of similar MIPS measures due to their belief that some
vendors may be misusing measures and diminishing the integrity of the
data, the quality of feedback to physicians, and ability to compare
performance. The commenters further cited their belief that such
harmonization can lead to inconsistencies in implementation, yielding
incomparable results and inaccurate benchmarking due to lack of
accountability and standardization across registries which may be
employing different methods for obtaining, risk adjusting, and
aggregating data, thereby creating variations in how clinicians are
measured and how their care is classified.
Response: To clarify, in the CY 2019 PFS proposed rule (83 FR
35984), we indicated that the QCDRs would be required to use the QCDR
measure without any modification, and would have to report on the
measure utilizing the CMS assigned measure ID. We encourage QCDRs to
work together through measure harmonization, and to reach out to QCDR
measure owners when they believe a revision to the measure
specification is appropriate, for the QCDR measure owner to consider.
Comment: A few commenters suggested the proposal to require QCDRs
to license measures to CMS should include allowing qualified registries
and other non-QCDR submitter types to also report QCDR measures; only
counting measures developed by a QCDR to count toward the 30 measure
threshold; and requiring QCDR measure owners to provide detailed
specifications including ICD-10-CM codes, CPT codes, required clinical
data elements, et cetera, so that all QCDR registries administer the
specification uniformly, and developing a system to properly record and
track ownership rights, including making ownership information CMS
collects available to QCDRs to better facilitate sharing of QCDR
measures between QCDR stewards. Commenters also suggested that CMS
reserve the right of the measure owner to review interim performance
results of other QCDRs utilizing their measures with full cooperation
of the other QCDRs to ensure performance results do not vary
significantly between QCDRs, thereby ensuring alignment on execution of
the measure specification between QCDRs before performance is scored
and future benchmarks are impacted.
Response: To clarify, we are only allowing other QCDRs to report on
the QCDR measures. Other submitter types would not have the QCDR
measures available for reporting. As discussed in the CY 2018 Quality
Payment Program final rule (82 FR 53811), QCDRs have the capability to
develop and submit for consideration up to 30 QCDR measures per
performance period. However, there is no limit as to the number of MIPS
quality measures they intend on supporting for a given performance
period. We disagree that QCDR measures should be available for
reporting by non-QCDR submitter types. As we provide QCDRs with
feedback on harmonizing or using QCDR measures owned by other QCDRs, we
encourage them to reach out to the QCDRs specifically for the detailed
specification inclusive of ICD-10 and CPT codes, as each measure owner
is responsible for tracking ownership

[[Page 59905]]

rights. The MIPS quality measures provide a detailed measure
specification to allow consistency in implementation, but data
abstraction may include multiple methods. We would require QCDRs to
follow a similar approach, where QCDRs would need to provide a detailed
specification to the QCDRs approved to submit the QCDR measure. This
would include any applicable ICD-10-CM codes, CPT codes, required
clinical data elements, et cetera, to allow implementation with minimal
variance. We would like to hear from QCDRs on whether or not they would
find this useful; and if this effort will increase burden on their end
regarding measure specification development. We will take the
suggestion that CMS reserve the right of the measure owner to review
interim performance results of other QCDRs utilizing their measures
into consideration for future rulemaking.
Comment: A few commenters stated that the proposal blurs the line
between QCDR measures and Quality Payment Program measures and would
eliminate the ability for a QCDR to ``test'' a measure in the sandbox
of their own QCDR before submitting it to CMS to become a Quality
Payment Program measure under the Measures Under Consideration (MUC)
process. Finally, one commenter suggested that if a measure owner was
ready to make a measure available for reporting by all of the Quality
Payment Program, they should submit it to CMS under the MUC process.
Response: The QCDR measure approval process is not intended to act
as a test bed for measure concepts, we expect QCDRs to have measures
that are analytically sound, are reliable, and feasible. Furthermore,
we certainly encourage that if a measure owner is ready to make a
measure available for reporting by all of the Quality Payment Program,
they should submit it to CMS under the MUC process as discussed in
section III.I.3.h.(2)(b)(i) of the CY 2019 PFS proposed rule (83 FR
35898 through 35899).
Comment: One commenter stated its belief that the proposal does not
align with the intended purpose of the MACRA grant for measure
development, which they further noted demonstrates the federal
government's recognition of measure development expense. A second
commenter stated that the proposal lacks provisions on how to determine
whether a specific measure is intended for another population and that
the absence of such provisions can lead to inappropriate
implementations in patient populations with the inability of the
measure owner to review data collected on their measures and maintain
the measures appropriately.
Response: We do not believe this policy would not align with the
MACRA grant for measure development, since generally across all quality
programs we are looking to reduce the number of duplicative measures
available for reporting and to transition to more outcomes based
measures. We believe that QCDRs exist to address measurement gaps as
identified by the specialists and that QCDRs are intended to address
gaps in measurement that would better reflect a clinician's scope of
practice. Based on the updates to the QCDR definition we have finalized
in this final rule (in the above section) for the 2020 performance
period of MIPS, we believe we will be able to further vet QCDR
applications to ensure that approved QCDRs would have the clinical
expertise and measure development experience. We are also streamlining
the number of measures available to clinicians in order to align with
our Meaningful Measures initiative. We note that our review and
approval of the QCDR measures will follow our existing process
utilizing the QCDR measure evaluation criteria as detailed through sub-
regulatory guidance in the 2019 QCDR Measure Development Handbook,
located in the 2019 Self-Nomination Toolkit on the Quality Payment
Program Resource Library web page at https://www.cms.gov/Medicare/Quality-Payment-Program/Resource-Library/2018-Resources.html. Once the
QCDR measures have been finalized for the performance period, and the
specification has been finalized, we intend to post the list of QCDR
measure specifications for QCDRs to review and consider prior to
deciding whether or not they wish to support additional QCDR measures.
As a part of this consideration, we encourage QCDRs to review the
measure specifications to determine the populations addressed.
Comment: A few commenters supported the proposal to require QCDRs
to enter into licensing agreements with CMS as a condition of approval.
Reasons cited include their beliefs that the proposal allows different
vendors to have the ability to address different specialty needs
appropriately thereby providing greater choice to eligible clinicians,
increases the effectiveness of quality measurement, and increases the
relevance and usefulness of measures in evaluating the quality of care
provided to patients nationally by increasing the number of providers
reporting data.
Response: We thank the commenters for their support but as noted
previously we are not finalizing this policy at this time.
Comment: A few commenters stated that CMS should adopt a model
where one measure is supported by one entity that represents a single
clinical domain or subspecialty as they noted doing so will enhance
consistency and validity across measurements; allow for a single method
for data aggregation, analytics, and reporting; reduce benchmarking
issues; decrease the risk of clinicians being misclassified in the
quality of care they provide; and remedy CMS' lack of ability to co-
aggregate data from multiple data sources and properly risk-adjust
measures. The commenters noted that the approved registry should be
required to meet standards for data which include rigor in explicitly
defining data elements used in the measurement, serve as a single
source of data aggregation and data normalization to secure data
integrity, apply approved and consistent statistical standards for
analytics, respond to clinical and methodological questions, and be
responsible for reporting requirements as defined by CMS. One commenter
further noted that CMS policy should require QCDRs to always refer
eligible clinician questions on specific measures back to the measure
steward, prohibit vendors and other QCDRs from specifying CQMs into
eCQMs without permission, require QCDRs to use current measure
specifications, and require CMS to publicly post complete measure
specifications, where appropriate, to the CMS Quality Payment Program
resources website to ensure all registries are implementing the most
updated measure specifications.
Response: We are not looking to set limitations, such as, one
clinical domain being assigned to one entity. We have multiple
instances where there are a few QCDRs covering similar areas (that is,
surgery, anesthesia, rheumatology). We would appreciate thoughts on how
we can reduce benchmarking issues to thereby incentivize QCDR measure
reporting. QCDRs are required to meet CMS data aggregation and
reporting requirements and agree that it is important that QCDRs are
able to meet data integrity standards in using data elements for
purposes of measurement. We believe there are circumstances out of CMS'
control where the clinician will reach out to the QPP service center
for assistance with a measure related question or to the QCDR they are
specifically working with. It would not be feasible to set such a
requirement when we could not monitor that it would be followed. We
encourage clinicians who have questions on the

[[Page 59906]]

QCDR measure specifications to reach out directly to the QCDR measure
owner in order to gain clarity on their questions. We agree, however,
that the QCDR must use the measure in its original state. QCDRs have to
use the measure in its ``as is'' state; meaning, how it was approved
for the given performance period. We post QCDR measure specifications,
inclusive of: The measure's specialty; QCDR name; measure title;
measure description; denominator; numerator; denominator exclusions;
denominator exceptions; numerator exclusions; data source used; NQF
number (if applicable); NQS domain; whether the measure is high
priority, outcome; measure type; whether the measure is inverse,
proportional, continuous variable, ratio; the range of scores if the
measure is continuous variable or ratio measures; number of performance
rates submitted; overall performance rate; whether the measure is risk-
adjusted; if risk-adjusted, and which score is risk-adjusted within the
QPP resource library. The systems are programmed on an annual basis to
only accept those QCDR measures and correlated specifications as
approved for the upcoming performance period.
Based on the feedback and concerns raised by stakeholders, in the
interim, we are not finalizing at Sec. 414.1400(b)(3)(ii)(C) that as a
condition of a QCDR measure's approval for purposes of MIPS, the QCDR
measure owner would be required to agree to enter into a license
agreement with CMS, permitting any approved QCDR to submit data on the
QCDR measure (without modification) for purposes of MIPS and each
applicable MIPS payment year. Rather we are retaining our existing
policy that QCDR vendors may seek permission from another QCDR to use
an existing measure that is owned by the other QCDR (82 FR 53813). We
remain very concerned about duplicative measures and their impact to
our meaningful measures initiative. We are eager to work with the
stakeholder community to determine solutions for this issue and will
continue to look for policy resolutions to address this issue.
We are finalizing our proposal at Sec. 414.1400(b)(3)(iii) that
other QCDRs would be required to use the same CMS-assigned QCDR measure
ID.
(4) Qualified Registries
We refer readers to Sec. 414.1400 and the CY 2018 Quality Payment
Program final rule (82 FR 53815 through 53818) for our previously
finalized policies regarding qualified registries. In the CY 2019 PFS
proposed rule (83 FR 35984), we proposed to update: Information
required for qualified registries at the time of self-nomination and
the self-nomination period for qualified registries.
(a) Establishment of an Entity Seeking To Qualify as a Qualified
Registry
In the CY 2017 Quality Payment Program final rule (81 FR 77383), we
state at Sec. 414.1400(h)(2) that the qualified registry must have at
least 25 participants by January 1 of the performance period. These
participants do not need to use the qualified registry to report MIPS
data to us; rather, they need to submit data to the qualified registry
for quality improvement. We realize that a qualified registry's lack of
preparedness to accept data from MIPS eligible clinicians and groups
beginning on January 1 of the performance period may negatively impact
a clinician's ability to use a Qualified Registry to report, monitor
the quality of care they provide to their patients (and act on these
results) and may inadvertently increase clinician burden. For these
reasons, in the CY 2019 PFS proposed rule (83 FR 35984), we proposed to
redesignate Sec. 414.1400(h)(2) as Sec. 414.1400(c)(2) to state that
beginning with the 2022 MIPS Payment Year, the qualified registry must
have at least 25 participants by January 1 of the year prior to the
applicable performance period. These participants do not need to use
the qualified registry to report MIPS data to us; rather, they need to
submit data to the qualified registry for quality improvement.
We did not receive any comments on the ``Establishment of an Entity
Seeking To Qualify as a Qualified Registry.'' We are finalizing our
proposal to redesignate Sec. 414.1400(h)(2) as Sec. 414.1400(c)(2) to
state that beginning with the 2022 MIPS Payment Year, the qualified
registry must have at least 25 participants by January 1 of the year
prior to the applicable performance period.
(b) Self-Nomination Process
We refer readers to Sec. 414.1400(g), the CY 2017 and CY 2018
Quality Payment Program final rules (81 FR 77383 and 82 FR 53815,
respectively) for our previously established policies regarding the
self-nomination process for qualified registries. We did not propose
any changes to this policy.
(c) Self-Nomination Period
Under the previously finalized policy at Sec. 414.1400(g),
qualified registries must self-nominate from September 1 of the year
prior to the applicable performance period until November 1 of the same
year and must, among other things, provide all information requested by
us at the time of self-nomination. To maintain alignment with the
timelines proposed for QCDR self-nomination, as discussed in section
III.I.3.k.(3)(c) of this final rule, we also proposed in the CY 2019
PFS proposed rule (83 FR 35985) to update the self-nomination period
from September 1 of the year prior to the applicable performance period
until November 1 to July 1 of the calendar year prior to the applicable
performance period until September 1. Specifically, we proposed in the
CY 2019 PFS proposed rule (83 FR 35985) at Sec. 414.1400(c)(1) that,
beginning with the 2022 MIPS payment year, entities seeking to qualify
as qualified registries must self-nominate during a 60-day period
beginning on July 1 of the calendar year prior to the applicable
performance period and ending on September 1 of the same year; must
provide all information required by us at the time of self-nomination;
and must provide any additional information requested by us during the
review process. For example, for the 2022 MIPS payment year, the
applicable performance period would be CY 2020, as discussed in section
III.I.3.g. of this final rule. Therefore, the self-nomination period
for qualified registries would begin on July 1, 2019 and end on
September 1, 2019.
We did not receive any comments on the ``Self-nomination Period''
for Qualified Registries. We are finalizing our proposal to amend Sec.
414.1400(c)(1) to provide that, beginning with the 2022 MIPS payment
year, entities seeking to qualify as qualified registries must self-
nominate during a 60-day period beginning on July 1 of the calendar
year prior to the applicable performance period and ending on September
1 of the same year; must provide all information required by us at the
time of self-nomination; and must provide any additional information
requested by us during the review process.
(5) Health IT Vendors or Other Authorized Third Parties That Obtain
Data From MIPS Eligible Clinicians' Certified EHR Technology (CEHRT)
We refer readers to Sec. 414.1400 and the CY 2017 Quality Payment
Program final rule (81 FR 77377 through 77382) for our previously
finalized policies regarding health IT vendors or other authorized
third parties that obtain data from MIPS eligible clinicians. We
finalized that health IT vendors that obtain data from a MIPS eligible
clinician, like other third party intermediaries, would have to meet
all criteria designated by us as a condition

[[Page 59907]]

of their qualification or approval to participate in MIPS as a third
party intermediary. This includes submitting data in the form and
manner specified by us. In the CY 2019 PFS proposed rule (83 FR 35985),
we proposed to codify these policies at Sec. 414.1400(d). Although we
specified criteria for a health IT vendor in the CY 2017 Quality
Payment Program final rule, we failed to codify the definition of a
health IT vendor. Therefore, in the CY 2019 PFS proposed rule (83 FR
35985), we proposed to define at Sec. 414.1305, that health IT vendor
means an entity that supports the health IT requirements on behalf of a
MIPS eligible clinician (including obtaining data from a MIPS eligible
clinician's CEHRT).
As indicated in footnote 1 of the CY 2017 Quality Payment Program
final rule (81 FR 77014 through 77015), the term ``health IT vendor''
encompasses many types of entities that support the health IT
requirements on behalf of a MIPS eligible clinician. A ``health IT
vendor'' may or may not also be a ``health IT developer'' for the
purposes of the ONC Health IT Certification Program (Program), and, in
some cases, the developer and the vendor of a single product may be
different entities. Under the Program, a health IT developer
constitutes a vendor, self-developer, or other entity that presents
health IT for certification or has health IT certified under the
Program. Other health IT vendors may maintain a range of data
transmission, aggregation, and calculation services or functions, such
as organizations which facilitate health information exchange.
We did not receive any comments on the ``Health IT Vendors or Other
Authorized Third Parties That Obtain Data From MIPS Eligible
Clinicians' Certified EHR Technology (CEHRT).'' Therefore, we are
finalizing our proposal to codify our previously established policies
at Sec. 414.1400(d). We are also finalizing our proposal to define at
Sec. 414.1305, that health IT vendor means an entity that supports the
health IT requirements on behalf of a MIPS eligible clinician
(including obtaining data from a MIPS eligible clinician's CEHRT).
(6) CMS-Approved Survey Vendors
In the CY 2017 Quality Payment Program final rule (81 FR 77386), we
finalized the criteria, required forms, and vendor business
requirements needed to participate in MIPS as a CMS-approved survey
vendor. In the CY 2019 PFS proposed rule (83 FR 35985), we proposed at
Sec. 414.1400(e) to codify these previously finalized criteria and
requirements. Accordingly, we proposed in the CY 2019 PFS proposed rule
(83 FR 35985) at Sec. 414.1400(e) that an entity seeking to be a CMS-
approved survey vendor for any MIPS performance period must submit a
survey vendor application to CMS in a form and manner specified by CMS
for each MIPS performance period for which it wishes to transmit such
data. We also proposed to require that the application and any
supplemental information requested by CMS must be submitted by
deadlines specified by CMS. In addition, we proposed that a CMS-
approved survey vendor must meet several criteria. First, we proposed
to require that an entity have sufficient experience, capability, and
capacity to accurately report CAHPS data, including:
At least 3 years of experience administering mixed-mode
surveys (surveys that employ multiple modes to collect data) that
include mail survey administration followed by survey administration
via Computer Assisted Telephone Interview (CATI);
At least 3 years of experience administering surveys to a
Medicare population;
At least 3 years of experience administering CAHPS surveys
within the past 5 years;
Experience administering surveys in English and one of the
following languages: Cantonese; Korean; Mandarin; Russian; or
Vietnamese;
Use of equipment, software, computer programs, systems,
and facilities that can verify addresses and phone numbers of sampled
beneficiaries, monitor interviewers, collect data via CATI,
electronically administer the survey and schedule call-backs to
beneficiaries at varying times of the day and week, track fielded
surveys, assign final disposition codes to reflect the outcome of data
collection of each sampled case, and track cases from mail surveys
through telephone follow-up activities; and
Employment of a program manager, information systems
specialist, call center supervisor and mail center supervisor to
administer the survey.
Furthermore, we proposed in the CY 2019 PFS proposed rule (83 FR
35985) that to be a CMS-approved survey vendor, the entity must also
meet the following criteria:
It must have certified that it has the ability to maintain
and transmit quality data in a manner that preserves the security and
integrity of the data;
The entity must have successfully completed, and required
its subcontractors to successfully complete, vendor training(s)
administered by CMS or its contractors;
The entity must have submitted a quality assurance plan
and other materials relevant to survey administration, as determined by
CMS, including cover letters, questionnaires and telephone scripts;
The entity must have agreed to participate and cooperate,
and have required its subcontractors to participate and cooperate, in
all oversight activities related to survey administration conducted by
CMS or its contractors; and
The entity must have sent an interim survey data file to
CMS that establishes the entity's ability to accurately report CAHPS
data.
We also refer readers to the CY 2018 Quality Payment Program final
rule (82 FR 53818 through 53819) for our previously established
policies regarding the updated survey vendor application deadline.
The following is a summary of the public comments received on the
``CMS-Approved Survey Vendors'' proposals and our responses:
Comment: A few commenters commended CMS for making the CAHPS for
Physician Quality Reporting System (PQRS) survey available in
Cantonese, Korean, Mandarin, Russian, Spanish, and Vietnamese and for
making the Medicare Accountable Care Organization CAHPS survey
available in Cantonese, Korean, Mandarin, Portuguese, Russian, Spanish,
and Vietnamese. These commenters encouraged CMS to work with
stakeholders to develop validated translations of all CAHPS surveys
used in MIPS and APMs in at least the top ten primary languages among
Medicare beneficiaries.
Response: We appreciate the commenters' feedback. We have made the
CAHPS for MIPS survey available in Spanish and we will continue to work
with stakeholders to develop additional translations of the surveys. In
addition, because the CAHPS for MIPS survey is available in Spanish and
may become available in other languages in the future, we believe it is
appropriate to modify our proposed requirement at Sec.
414.1400(e)(1)(iv) to more broadly state that an entity must have
experience administering surveys in English and at least one other
language for which a translation of the CAHPS for MIPS survey is
available. These languages currently consist of Cantonese, Korean,
Mandarin, Russian, Spanish, and Vietnamese.
After consideration of the public comments received, we are
finalizing our proposal at Sec. 414.1400(e) to state that entities
seeking to be a CMS-approved survey vendor for any MIPS

[[Page 59908]]

performance period must submit a survey vendor application to CMS in a
form and manner specified by CMS for each MIPS performance period for
which it wishes to transmit such data; and that the application and any
supplemental information requested by CMS must be submitted by
deadlines specified by CMS. We are also finalizing our proposal at
Sec. 414.1400(e) that a CMS-approved survey vendor must meet several
criteria that consists of the following:
An entity must have sufficient experience, capability, and capacity
to accurately report CAHPS data, including:
At least 3 years of experience administering mixed-mode
surveys (surveys that employ multiple modes to collect data) that
include mail survey administration followed by survey administration
via Computer Assisted Telephone Interview (CATI);
At least 3 years of experience administering surveys to a
Medicare population;
At least 3 years of experience administering CAHPS surveys
within the past 5 years;
Experience administering CAHPS surveys in English and at
least one other language for which a translation of the CAHPS for MIPS
survey is available. These languages currently consist of Cantonese,
Korean, Mandarin, Russian, Spanish or Vietnamese;
Use of equipment, software, computer programs, systems,
and facilities that can verify addresses and phone numbers of sampled
beneficiaries, monitor interviewers, collect data via CATI,
electronically administer the survey and schedule call-backs to
beneficiaries at varying times of the day and week, track fielded
surveys, assign final disposition codes to reflect the outcome of data
collection of each sampled case, and track cases from mail surveys
through telephone follow-up activities; and
Employment of a program manager, information systems
specialist, call center supervisor and mail center supervisor to
administer the survey.
In addition, we are finalizing without change our proposal that an
entity must have certified that it has the ability to maintain and
transmit quality data in a manner that preserves the security and
integrity of the data; the entity must have successfully completed, and
has required its subcontractors to successfully complete, vendor
training(s) administered by CMS or its contractors; the entity must
have submitted a quality assurance plan and other materials relevant to
survey administration, as determined by CMS, including cover letters,
questionnaires and telephone scripts; the entity must have agreed to
participate and cooperate, and have required its subcontractors to
participate and cooperate, in all oversight activities related to
survey administration conducted by CMS or its contractors; and the
entity must have sent an interim survey data file to CMS that
establishes the entity's ability to accurately report CAHPS data.
(7) Auditing of Third Party Intermediaries Submitting MIPS Data
In the CY 2018 Quality Payment Program final rule (82 FR 53819), we
established at Sec. 414.1400(j) policies regarding auditing of third
party intermediaries submitting MIPS data. In the CY 2019 PFS proposed
rule (83 FR 35985), we did not propose any changes to these policies.
In this final rule, the provision that currently appears at Sec.
414.1400(j) is redesignated as Sec. 414.1400(g) and contains no
substantive changes.
(8) Remedial Action and Termination of Third Party Intermediaries
In the CY 2017 Quality Payment Program final rule (81 FR 77548), we
finalized the criteria for probation and disqualification for third
party intermediaries at Sec. 414.1400(k). In the CY 2019 PFS proposed
rule (83 FR 35986), we proposed to revise the numbering of this section
and the title to more accurately describe the policies in this section.
Specifically, we proposed to renumber this section as Sec. 414.1400(f)
and to rename it as ``remedial action and termination of third party
intermediaries.'' Additionally, we proposed in the CY 2019 PFS proposed
rule (83 FR 35986) changes to Sec. 414.1400(f) to amend, clarify, and
streamline our policies related to remedial action and termination.
Our intent with these policies is to identify and remedy
noncompliance with the applicable third party intermediary criteria, as
well as identify issues that may impact the accuracy of or our ability
to use the data submitted by third party intermediaries. Accordingly,
in the CY 2019 PFS proposed rule (83 FR 35986), we proposed to amend
Sec. 414.1400(f)(1) to state that we may take remedial action for
noncompliance with applicable third party intermediary criteria for
approval (a deficiency) or for the submission of inaccurate, unusable,
or otherwise compromised data. In the CY 2017 Quality Payment Program
final rule, we finalized our policy regarding data inaccuracies at
Sec. 414.1400(k)(4). In the CY 2019 PFS proposed rule (83 FR 35986),
we proposed at Sec. 414.1400(f)(3) to expand data inaccuracies to
include a determination by us that data is inaccurate, unusable, or
otherwise compromised. However, we did not propose to change the
factors we may consider to make such a determination. In the CY 2019
PFS proposed rule (83 FR 35986), we also proposed to move the
notification requirement at Sec. 414.1400(k)(6) to Sec.
414.1400(f)(1) and to apply the requirement to all deficiencies and
data errors.
Based on our early experience with third party intermediaries under
MIPS and the challenges for both third party intermediaries and us in
regards to timing and trying to resolve deficiencies and data errors
within the various reporting and performance periods, we proposed in
the CY 2019 PFS proposed rule (83 FR 35986) to amend the timeframes by
which a third party intermediary must submit a Corrective Action Plan
(CAP) to us or come into compliance. Specifically, we proposed Sec.
414.1400(f)(2), which requires third party intermediaries to submit a
CAP or correct the deficiencies or data errors by the date specified by
us (83 FR 35986).
Additionally, we proposed in the CY 2019 PFS proposed rule (83 FR
35986) to consolidate at Sec. 414.1400(f)(1) the grounds for remedial
action against a third party intermediary currently specified at Sec.
414.1400(k)(1) and (4) and to consolidate at Sec. 414.1400(f)(2) the
grounds for terminating a third party intermediary currently found at
Sec. 414.1400(k)(3), (5) and (7). Therefore, we proposed at Sec.
414.1400(f)(1) that if at any time we determine that a third party
intermediary has ceased to meet one or more of the applicable criteria
for approval, or has submitted data that is inaccurate, unusable, or
otherwise compromised, we may take certain remedial actions (for
example, request a CAP) (83 FR 35986). In the CY 2019 PFS proposed rule
(83 FR 35986), we also proposed at Sec. 414.1400(f)(2) that we may
terminate, immediately or with advance notice, the ability of a third
party intermediary to submit MIPS data on behalf of a MIPS eligible
clinician, group, or virtual group for one or more of the following
reasons: We have grounds to impose remedial action, we have not
received a CAP within the specified time period or the CAP is not
accepted by us, or the third party intermediary fails to correct the
deficiencies or data errors by the date specified by us.
Additionally, in the CY 2019 PFS proposed rule (83 FR 35986), we
proposed to consolidate at Sec. 414.1400(f)(1) the actions we may take

[[Page 59909]]

if we identify a deficiency or data error that are set forth at Sec.
414.1400(k)(3) and (7). Thus, we proposed at Sec. 414.1400(f)(1) in
the CY 2019 PFS proposed rule (83 FR 35986) that if we determine a
third party intermediary has ceased to meet one or more of the
applicable criteria for approval, or has submitted data that is
inaccurate, unusable, or otherwise compromised, we may require the
third party intermediary to submit a CAP to us to address the
identified deficiencies or data issue, including the actions it will
take to prevent the deficiencies or data issues from recurring. We
proposed to require that the CAP be submitted to CMS by a date
specified by CMS.
In the CY 2019 PFS proposed rule (83 FR 35986), we also proposed
that CMS may determine that submitted data is inaccurate, unusable, or
otherwise compromised if the submitted data: (1) Includes, without
limitation, TIN/NPI mismatches, formatting issues, calculation errors,
or data audit discrepancies; and (2) affects more than 3 percent (but
less than 5 percent) of the total number of MIPS eligible clinicians or
group for which data was submitted by the third party intermediary. In
addition, we proposed in the CY 2019 PFS proposed rule (83 FR 35986)
that if the third party intermediary has a data error rate of 3 percent
or more, we will publicly disclose the entity's data error rate on the
CMS website until the data error rate falls below 3 percent.
We clarify in this final rule that CMS may determine that submitted
data is inaccurate, unusable, or otherwise compromised if the submitted
data affects more than 3 percent of the total number of MIPS eligible
clinicians or group for which data was submitted by the third party
intermediary. In the CY 2017 Quality Payment Program final rule (81 FR
77387 through 77388), we explained that if a third party intermediary
has data inaccuracies including (but not limited to) TIN/NPI
mismatches, formatting issues, calculation errors, data audit
discrepancies affecting in excess of 3 percent (but less than 5
percent) of the total number of MIPS eligible clinicians or groups
submitted by the third party intermediary, we would annotate on the CMS
qualified posting that the third party intermediary furnished data of
poor quality and would place the entity on probation for the subsequent
MIPS performance period. If a third party intermediary does not reduce
their data error rate below 3 percent for the subsequent performance
period, the third party intermediary would continue to be on probation
and have their listing on the CMS website continue to note the poor
quality of the data they are submitting for MIPS for one additional
performance year. After 2 years on probation, the third party
intermediary would be disqualified for the subsequent performance year.
We also explained that data errors affecting in excess of 5 percent of
MIPS eligible clinicians or group submitted by the third party
intermediary may lead to the disqualification of the third party
intermediary from participation for the following performance period
(that is, without first placing the third party intermediary on
probation).
Accordingly, it was always our intent that data errors affecting in
excess of 3 percent of the MIPS eligible clinicians or group submitted
by a third party intermediary would result in remedial action or
disqualification (termination) of the third party intermediary. In this
final rule, we are correcting an obvious error in the regulation text
we proposed at Sec. 414.1400(f)(3)(ii) to clarify that if submitted
data is inaccurate, unusable, or otherwise compromised if errors in the
submitted data affect more than 3 percent of the total number of MIPS
eligible clinicians or group for which data was submitted by the third
party intermediary.
Finally, we proposed to remove our probation policy. Therefore, we
proposed in the CY 2019 PFS proposed rule (83 FR 35986) to remove the
definition of probation at Sec. 414.1400(k)(2) and references to
probation in Sec. 414.1400(k)(1), (3) and (5).
The following is a summary of the public comments received on the
``Remedial Action and Termination of Third Party Intermediaries''
proposals and our responses:
Comment: One commenter stated that CMS should put in place a safe
harbor policy in order to minimize the impact on clinicians when a data
issue outside of a clinician's or group's control occurs due to a third
party intermediary. The commenter indicated that, under those
circumstances, CMS should automatically consider the clinician or group
to have satisfied the quality performance category. The commenter cited
concerns with the transition and upgrade to 2015 CEHRT and references
data issues under 2016 PQRS related to the 2014 CEHRT upgrade.
Response: We do not agree that we should create a safe harbor
policy to address the circumstances described by the commenter.
Instead, we believe it would be appropriate to address data issues on a
case-by-case basis. As we discussed in the CY 2018 Quality Payment
Program final rule (82 FR 53807), we expect third party intermediaries
to develop processes to ensure that the data and information they
submit to CMS on behalf of MIPS eligible clinicians, groups, and
virtual groups are true, accurate, and complete; we also rely on the
third party intermediaries to address these issues in its arrangements
and agreements with other entities, including MIPS eligible clinicians,
groups, and virtual groups.
Comment: One commenter agreed with the proposal to remove the
probation policy.
Response: We appreciate the commenter's support.
Comment: A few commenters disagreed with our proposal at Sec.
414.1400(f)(2) because it would allow us to immediately or with advance
notice terminate a third party intermediary's ability to submit MIPS
data without first placing the third party intermediary on probation.
The commenters believe that termination should occur only with advance
notice through a clearly defined process that reflects the current
procedure set forth at Sec. 414.1400(f). Commenters suggested that
CMS' termination procedure include formal consideration of a CAP.
Response: We appreciate the commenters' concerns, and therefore, we
expect that in most circumstances, we would take remedial action,
including imposition of a CAP, prior to terminating the ability of a
third party intermediary to submit MIPS data on behalf of a MIPS
eligible clinician, group, or virtual group. Before deciding whether to
terminate a third party intermediary's ability to submit MIPS data, we
would take into account a third party intermediary's actions, the
severity of the non-compliance or errors at issue, and the potential
for undue hardship or negative impact on affected eligible clinicians.
In addition, we would expect to provide advance notice of most
terminations; we would likely impose immediate termination on a third
party intermediary's ability to submit MIPS data only in circumstances
where egregious non-compliance or data errors have occurred. However,
if we have not received a CAP within the specified time period or the
CAP is not accepted by us, or the third party intermediary fails to
correct the deficiencies or data errors by the date specified by us, we
may terminate the third party intermediary, immediately or with advance
notice.
Comment: A few commenters stated that the proposed termination
policy could result in undue hardship on or negatively impact affected
eligible clinicians should termination occur during a performance
period.

[[Page 59910]]

Response: We recognize that termination of a third party
intermediary's ability to submit MIPS data during a performance period
may result in undue hardship on eligible clinicians who are supported
by the third party intermediary. Therefore, we would consider whether a
third party intermediary is supporting eligible clinicians in deciding
when to terminate the ability of the third party intermediary to submit
MIPS data. In addition, we will consider for future rulemaking whether
a third party intermediary should be required to submit to CMS a
transition plan that addresses how submission of data would be handled
in the event that termination occurs during a performance period.
Comment: A few commenters representing QCDRs and qualified
registries stated that CMS should clearly define, and provide examples
of, a ``data error'' for purposes of determining a third party
intermediary's data error rate, which may be disclosed publicly by CMS
if it exceeds 3 percent. In addition, the commenters stated that CMS
should set forth how the data error rate is calculated and develop a
report that describes and differentiates data errors and other
``issues'' that should be brought to a third party intermediary's
attention.
Response: The ``data error rate'' measures the amount of data
submitted by a third party intermediary that was ``inaccurate,
unusable, or otherwise compromised.'' Additional material regarding
data inaccuracies and error rates is available in the ``2019 Qualified
Clinical Data Registry (QCDR) Fact Sheet'' and the ``2019 Qualified
Registry Fact Sheet'' in the 2019 Self-Nomination Toolkit for QCDRs &
Registries, located in the Quality Payment Program Resource Library at
https://www.cms.gov/Medicare/Quality-Payment-Program/Resource-Library/2018-Resources.html. We appreciate the suggestion of creating a report
that describes data errors and ``other issues,'' however, we believe
that our existing material addresses the commenters' concern.
After consideration of the public comments received, we are
finalizing our proposal to revise the numbering of Sec. 414.1400(k) as
Sec. 414.1400(f) and to rename it as ``remedial action and termination
of third party intermediaries.'' We are also finalizing our proposal to
amend, clarify, and streamline our policies related to remedial action
and termination as follows:
We are finalizing Sec. 414.1400(f)(1) to state that CMS
may take one or more of the following remedial actions if we determine
that a third party intermediary has ceased to meet one or more of the
applicable third party intermediary criteria for approval or has
submitted data that is inaccurate, unusable, or otherwise compromised:
We will require the third party intermediary to submit by a deadline
specified by CMS a CAP that addressed the identified deficiencies or
data issue, including the actions it will take to prevent the
deficiencies or data issues from recurring; or we will publicly
disclose the entity's data error rate on the CMS website until the data
error rate falls below 3 percent.
We are finalizing Sec. 414.1400(f)(2) to state that CMS
may immediately or with advance notice terminate the ability of a third
party intermediary to submit MIPS data on behalf of a MIPS eligible
clinician group, or virtual group for one or more of the following
reasons: CMS has grounds to impose remedial action; CMS has not
received a CAP within the specified time period or the CAP is not
accepted by CMS; or, the third party intermediary fails to correct the
deficiencies or data errors by the date specified by CMS.
We are finalizing Sec. 414.1400(f)(3) to state that, for
purposes of paragraph (f), CMS may determine that submitted data is
inaccurate, unusable, or otherwise compromised if it: Includes, without
limitation, TIN/NPI mismatches, formatting issues, calculation errors,
or data audit discrepancies; and affects more than 3 percent of the
total number of MIPS eligible clinicians or group for which data was
submitted by the third party intermediary.
l. Public Reporting on Physician Compare
This section contains our approach for public reporting on
Physician Compare for year 3 of the Quality Payment Program (2019 data
available for public reporting in late 2020) and future years,
including MIPS, APMs, and other information as required by the MACRA
and building on our previously finalized public reporting policies (see
82 FR 53819 through 53832).
Physician Compare (https://www.medicare.gov/physiciancompare) draws
its operating authority from section 10331(a)(1) of the Affordable Care
Act. Consistent with section 10331(a)(2) of the Affordable Care Act,
Physician Compare initiated a phased approach to publicly reporting
performance scores that provide comparable information on quality and
patient experience measures. A complete history of public reporting on
Physician Compare is detailed in the CY 2016 PFS final rule (80 FR
71117 through 71122). More information about Physician Compare,
including the history of public reporting and regular updates about
what information is currently available, can also be accessed on the
Physician Compare Initiative website at https://www.cms.gov/medicare/quality-initiatives-patient-assessment-instruments/physician-compare-initiative/.
As discussed in the CY 2018 Quality Payment Program final rule (82
FR 53820), Physician Compare has continued to pursue a phased approach
to public reporting under the MACRA in accordance with section
1848(q)(9) of the Act. Generally, all data available for public
reporting on Physician Compare must meet our established public
reporting standards under Sec. 414.1395(b). In addition, for each
program year, CMS provides a 30-day preview period for any clinician or
group with Quality Payment Program data before the data are publicly
reported on Physician Compare under Sec. 414.1395(d). All data
available for public reporting--measure rates, scores, and
attestations, objectives, etc.--are available for review and correction
during the targeted review process. See the CY 2018 Quality Payment
Program final rule for details on this process (82 FR 53820).
Lastly, section 104(e) of the MACRA requires the Secretary to make
publicly available, on an annual basis, in an easily understandable
format, information for physicians and, as appropriate, other eligible
clinicians related to items and services furnished to Medicare
beneficiaries under Title XVIII of the Act. In accordance with section
104(e) of the MACRA, we finalized a policy in the CY 2016 PFS final
rule (80 FR 71131) to add utilization data to the Physician Compare
downloadable database.
We believe section 10331 of the Affordable Care Act supports the
overarching goals of the MACRA by providing the public with performance
information that will help them make informed decisions about their
health care, while encouraging clinicians to improve the quality of
care they provide to their patients. In accordance with section 10331
of the Affordable Care Act, section 1848(q)(9) of the Act, and section
104(e) of the MACRA, we plan to continue to publicly report performance
information on Physician Compare. As such, the following sections
discuss the information previously finalized for inclusion on Physician
Compare for all program years, as well as our finalized policies for
public reporting on Physician Compare for year 3 of the Quality

[[Page 59911]]

Payment Program (2019 data available for public reporting in late 2020)
and future years.
We received several miscellaneous comments, but since these were
not applicable to specific proposals made, these comments are outside
the scope of this section and the proposed rule.
(1) Final Score, Performance Categories, and Aggregate Information
In the CY 2018 Quality Payment Program final rule (82 FR 53823), we
finalized a policy to publicly report on Physician Compare, either on
profile pages or in the downloadable database, the final score for each
MIPS eligible clinician and the performance of each MIPS eligible
clinician for each performance category, and to periodically post
aggregate information on the MIPS, including the range of final scores
for all MIPS eligible clinicians and the range of performance of all
the MIPS eligible clinicians for each performance category, as
technically feasible, for all future years. We will use statistical
testing and user testing, as well as consultation with the Physician
Compare Technical Expert Panel convened by our contractor, to determine
how and where these data are best reported on Physician Compare.
A summary of the previously finalized policies related to each
performance category of MIPS data, as well as finalized policies for
year 3 and future years, follows. It is important to note just because
performance information is available for public reporting, it does not
mean all data under all performance categories will be included on
either public-facing profile pages or the downloadable database. These
data must meet the public reporting standards, first. And, second, we
are careful to ensure that we do not include too much information on
public-facing profile pages in an effort not to overwhelm website
users. Although all information submitted under MIPS is technically
available for public reporting, we will continue our phased approach to
making this information public.
(2) Quality
In the CY 2018 Quality Payment Program final rule (82 FR 53824), we
finalized a policy to make all measures under the MIPS quality
performance category available for public reporting on Physician
Compare, either on profile pages or in the downloadable database, as
technically feasible. This includes all available measures across all
collection types for both MIPS eligible clinicians and groups, for all
future years. We will use statistical testing and website user testing
to determine how and where measures are reported on Physician Compare.
We will not publicly report first year quality measures, meaning any
measure in its first year of use in the quality performance category,
under Sec. 414.1395(c). We will also include the total number of
patients reported on for each measure included in the downloadable
database (82 FR 53824).
We proposed to modify Sec. 414.1395(b) to reference ``collection
types'' instead of ``submission mechanisms'' to accurately update the
terminology (83 FR 35987), consistent with the proposal to add this
term and its definition under Sec. 414.1305. We also proposed to
revise Sec. 414.1395(c) to indicate that we will not publicly report
first year quality measures for the first 2 years a measure is in use
in the quality performance category (83 FR 35987). We proposed this
change to encourage clinicians and groups to report new measures, get
feedback on those measures, and learn from the early years of reporting
measures before measure are made public. We requested comment on these
proposals.
The following is a summary of the comments we received on these
proposals and our responses.
Comment: Most commenters supported not publicly reporting first
year data on quality measures for the first 2 years to encourage
adoption of new measures and allow clinicians and groups to get
experience with and feedback on these measures before they are publicly
reported. One commenter noted concern with delaying the public
reporting of first year quality measures for the first 2 years they are
in use, stating it would slow the progress toward full Quality Payment
Program implementation and in fostering evaluation of more clinicians
reporting a consistent set of measures. A few commenters suggested that
3 years is a more appropriate length of time for delaying publicly
reporting first year measures, stating this timeframe would allow CMS
to adequately evaluate meaningful trends over time and provide
clinicians with an adequate period to fix data collection issues and
give clinicians more time to respond to performance feedback. A few
commenters requested that public reporting on Physician Compare be
delayed until the transition years to full Quality Payment Program
implementation end and there is more predictability, continuity,
consistency, and decreased complexity in the program. In addition,
several commenters submitted suggestions regarding transparency of
publicly reported performance data. One commenter requested that
Physician Compare note for publicly reported measures if a change to
clinical guidelines occurred during the performance year, so that the
data provided is not misleading to the public.
Response: We agree that not publicly reporting first year data on
quality measures for the first 2 years they are in use is sufficient
time to gain experience with them before they are considered for public
reporting and believe 2 years also meets the goal of providing more
timely and transparent information to the public on clinician
performance for making their healthcare decisions. We believe that
waiting 3 years to publicly report first year measures unnecessarily
hinders the ability to provide the public with transparent performance
information after clinicians have already received such feedback and
also reduces the non-financial incentive for clinicians to improve
their performance. Additionally, we do not believe that delaying the
public reporting of first year quality measures for the first 2 years
they are in use delays Quality Payment Program implementation or
evaluation of more clinicians reporting a consistent set of measures,
since, at this time, eligible clinicians and groups have the
flexibility to select from a broad list of measures and do not all need
to report the exact same measures. Regarding the comment suggesting
public reporting be delayed until the Quality Payment Program is fully
implemented, we note that we are required under section 1848(q)(9)(A)
and (D) of the Act to publicly report certain MIPS eligible clinician
and group performance information on Physician Compare. However, we do
recognize that we are in early stages of MIPS, which is why we are
continuing to publicly report this information under a phased approach.
In response to the suggestion to indicate, on Physician Compare, when a
measure specification has changed, we note that if there are
significant changes to a clinical guideline during the performance year
and the measure specifications do not reflect the current standard of
care, the measure is suppressed from MIPS scoring. Refer to
III.I.3.i.(1)(b)(vii) of this final rule for more information on the
scoring policy. Only data that meet our established public reporting
standards under Sec. 414.1395(b) will be publically reported on
Physician Compare.
Regarding the comments supporting data transparency, we agree that
for public reporting to be meaningful to all stakeholders, transparency
is key. Each year we strive to actively share information, via the
Physician Compare

[[Page 59912]]

initiative page and other channels, on our public reporting efforts as
testing is completed and measures to be publicly reported are
finalized. Last year in response to similar comments, we produced
additional educational materials about the 5-star rating methodology
and cut-offs, for example. We will continue our educational efforts as
public reporting on Physician Compare evolves. We also reiterate our
belief in the importance of clinicians reviewing their data for
accuracy prior to it being publicly reported. All performance data
publicly reported on Physician Compare will reflect the scores eligible
clinicians and groups receive in their MIPS performance feedback, which
are available for review and correction during the targeted review
process.
After consideration of the comments, we are finalizing our proposal
to revise Sec. 414.1395(c) to indicate that we will not publicly
report first year quality measures for the first 2 years a measure is
in use in the quality performance category. We did not receive any
comments on changing ``submission mechanism'' to ``collection type''
for the purposes of public reporting, and as a result are finalizing
our proposal to modify Sec. 414.1395(b) to reference ``collection
types'' instead of ``submission mechanisms''.
(3) Cost
In the CY 2018 Quality Payment Program final rule (82 FR 53825), we
finalized a policy to include on Physician Compare a subset of cost
measures that meet the public reporting standards at Sec. 414.1395(b),
either on profile pages or in the downloadable database, if technically
feasible, for all future years. This includes all available cost
measures, and applies to both MIPS eligible clinicians and groups. We
will use statistical testing and website user testing to determine how
and where measures are reported on Physician Compare. We previously
finalized that we will not publicly report first year cost measures,
meaning any measure in its first year of use in the cost performance
category, under Sec. 414.1395(c).
Consistent with our proposal for first year quality measures, we
proposed to revise Sec. 414.1395(c) to indicate that we will not
publicly report first year cost measures for the first 2 years a
measure is in use in the cost performance category (83 FR 35987). We
proposed this change to help clinicians and groups get feedback on
these measures and learn from the early years of these new measures
being calculated before measure are made public (83 FR 35987). We
requested comment on this proposal.
The following is a summary of the comments we received on this
proposal and our responses.
Comment: Most commenters supported not publicly reporting first
year data on cost measures for the first 2 years to encourage adoption
of new measures and allow clinicians and groups to get experience with
and feedback on these measures before they are publicly reported. One
commenter expressed concern that delaying the public reporting of first
year cost measures for the first 2 years they are in use, stating it
would slow the progress toward full Quality Payment Program
implementation and in fostering evaluation of more clinicians reporting
a consistent set of measures. Another commenter recommended, separately
from the other cost measures, that we consider extending the timeframe
for which the new episode-based cost measures are publicly reported, so
that there is time to gain experience with collecting and analyzing
these measures.
Response: We agree that not publicly reporting first-year data on
cost measures for the first 2 years they are in use is sufficient time
to gain experience with them, including for the new episode-based cost
measures, before they are considered for public reporting and believe 2
years also meets the goal of providing more timely and transparent
information to the public on clinician performance for making their
healthcare decisions. We believe that waiting 3 years to publicly
report first year measures hinders the ability to provide the public
with transparent information after clinicians will have already
received such feedback and also reduces the non-financial incentive for
clinicians to improve their performance. Additionally, we do not
believe that delaying the public reporting of first year quality
measures for the first 2 years they are in use delays Quality Payment
Program implementation and in fostering evaluation of more clinicians
reporting a consistent set of measures, as the cost performance
category's full implementation is already delayed. We also do not
believe there is a need or benefit to set a different timeframe for
episode-based measures than there is for other cost measures that will
also have 2 years of usage prior to being considered for public
reporting.
After consideration of the comments, we are finalizing our proposal
to revise Sec. 414.1395(c) to indicate that we will not publicly
report first year cost measures for the first 2 years a measure is in
use.
(4) Improvement Activities
In the CY 2018 Quality Payment Program final rule (82 FR 53826), we
finalized a policy to include a subset of improvement activities
information on Physician Compare, either on the profile pages or in the
downloadable database, if technically feasible, for all future years.
This includes all available activities reported via all available
collection types, and applies to both MIPS eligible clinicians and
groups. For those eligible clinicians and groups that successfully meet
the improvement activities performance category requirements, this
information will be posted on Physician Compare as an indicator. We
also finalized for all future years to publicly report first year
activities if all other public reporting criteria are satisfied.
(5) Promoting Interoperability (PI)
In the CY 2018 Quality Payment Program final rule (82 FR 53827), we
finalized a policy to include an indicator on Physician Compare for any
eligible clinician or group who successfully meets the Promoting
Interoperability performance category, as technically feasible, for all
future years. ``Successful'' performance is defined as obtaining the
base score of 50 percent (82 FR 53826). We also finalized a policy to
include on Physician Compare, either on the profile pages or in the
downloadable database, as technically feasible, additional information,
including, but not limited to, objectives, activities, or measures
specified in the CY 2018 Quality Payment Program final rule (82 FR
53827; see 82 FR 53663 through 53688). This includes all available
objectives, activities, or measures reported via all available
collection types, and applies to both MIPS eligible clinicians and
groups (82 FR 53827). We will use statistical testing and website user
testing to determine how and where objectives, activities, and measures
are reported on Physician Compare. We also finalized for all future
years to publicly report first year Promoting Interoperability
objectives, activities, and measures if all other public reporting
criteria are satisfied.
In addition, we finalized that we will indicate ``high''
performance, as technically feasible and appropriate, in year 2 of the
Quality Payment Program (2018 data available for public reporting in
late 2019). ``High'' performance is defined as obtaining a score of 100
percent (82 FR 53826 through 53827).

[[Page 59913]]

As the Quality Payment Program progresses into year 3, and
consistent with our work to simplify the requirements under the
Promoting Interoperability performance category of MIPS, we proposed
not to include the indicator of ``high'' performance and to maintain
only an indicator for ``successful'' performance in the Promoting
Interoperability performance category beginning with year 2 of the
Quality Payment Program (2018 data available for public reporting in
late 2019) (83 FR 35988). Not including the ``high'' performance
indicator while maintaining the ``successful'' performance indicator
continues to provide useful information to patients and caregivers
without burdening website users with the additional complexity of
accurately differentiating between ``successful'' and ``high''
performance, as this proved difficult for users in testing. User
testing to date shows that website users value this information
overall, however, as they appreciate knowing clinicians and groups are
effectively using EHR technology to improve care quality (83 FR 35988).
We requested comment on our proposal not to include the indicator
for ``high'' performance in the Promoting Interoperability performance
category beginning with year 2 of the Quality Payment Program (2018
data available for public reporting in late 2019) (83 FR 35988).
The following is a summary of the comments we received on our
proposal and our responses.
Comment: The majority of commenters supported the proposal to move
to a designation of ``successful'' only and to remove the ``high''
designation in the Promoting Interoperability performance category, as
it offers a clear indication that clinicians are effectively using EHRs
and would make the user experience more straightforward than
delineating between multiple indicators. One commenter opposed the
proposal to only include a ``successful'' indicator, since in future
years it would be difficult to be ``successful,'' as defined, when the
base scores, performance scores, and bonus scores are changed or
removed. Another commenter requested clarification on how
``successful'' would be defined when the Promoting Interoperability
performance category no longer includes a base score.
Response: We agree that moving from having both a ``successful''
and ``high'' indicator of an eligible clinician or group's Promoting
Interoperability performance to having a single indicator of
``successful'' not only shows that clinicians are effectively using
EHRs, but also is easier for patients to understand. Additionally, it
is more technically feasible to designate a single ``successful''
indicator than both a ``successful'' and ``high'' indicator as the
Promoting Interoperability performance category scoring methodology
evolves and as we evaluate operational facets of the data. We wish to
also clarify that having only a ``successful'' indicator will apply to
individuals and groups who have a Promoting Interoperability
performance category score above zero.
After consideration of the public comments received, we are
finalizing our proposal to not include the indicator of ``high''
performance and to maintain only an indicator for ``successful''
performance in the Promoting Interoperability performance category
beginning with year 2 of the Quality Payment Program. We note that in
the CY 2017 Quality Payment Program final rule (81 FR 77397), we
finalized a policy to include, as technically feasible, additional
indicators, including but not limited to indicators such as,
identifying if the eligible clinician or group scores high performance
in patient access, care coordination and patient engagement, or health
information exchange. We have since determined that it is not
technically feasible to include an indicator of ``high'' performance
that meets our public reporting standards as defined at Sec.
414.1395(b) for year 1 of the Quality Payment Program. The reason we
are not reporting this indicator, is because based upon conducting
analysis against our public reporting standards, the scoring
variability in the Promoting Interoperability performance category of
the Quality Payment Program (year 1 to year 3) creates challenges that
we are still uncovering for making the data useful to Physician
Compare's primary patient and caregiver audience. Additionally, in
reviewing the year 1 data (which was not available at the time the CY
2019 proposed rule was released) we have learned through user testing
that patients and caregivers find clinician and group usage of EHR
technology to generally be a meaningful indicator of quality,
regardless of whether ``successful'' or ``high'' was noted. That is,
including the word ``high'' did not result in patients and caregivers
believing the clinician or group to be of higher quality than those
that had the word ``successful'' next to their Promoting
Interoperability performance category indicator. Therefore, the high
performing indicator will not be reported in year 1, 2, 3 or future
years of the Quality Payment Program on Physician Compare.
As noted above, we previously defined ``successful'' performance as
obtaining the base score of 50 percent (82 FR 53826). As discussed in
section III.I.3.h.(5) of this final rule, the Promoting
Interoperability performance category will no longer have a base score
beginning with year 3. To account for this change, we are finalizing a
modified definition of ``successful'' performance to mean a Promoting
Interoperability performance category score above zero beginning with
year 3. We will include the modified indicator (above zero) for years
1, 2, and 3 to avoid confusion and preserve year-to-year comparability,
and the previously finalized indicator (base score) for years 1 and 2
for transparency and consistency with our previously finalized policy,
as technically feasible.
We also solicited comment on the type of EHR utilization
performance information stakeholders would like CMS to consider adding
to Physician Compare. This information may be considered for possible
future inclusion on the website. We did not receive any comments.
(6) Achievable Benchmark of Care (ABC^TM)
Benchmarks are important to ensuring that the quality data
published on Physician Compare are accurately understood. A benchmark
allows website users to more easily evaluate the information published
by providing a point of comparison between groups and between
clinicians. In the CY 2018 Quality Payment Program final rule (82 FR
53829), we finalized a policy to use the Achievable Benchmark of Care
(ABC^TM) methodology to determine a benchmark for the
quality, cost, improvement activities, and Promoting Interoperability
data, as feasible and appropriate, by measure and collection type for
each year of the Quality Payment Program based on the most recently
available data each year. We also finalized a policy to use this
benchmark as the basis of a 5-star rating for each available measure,
as feasible and appropriate. For a detailed discussion of the
ABC^TM methodology, and more information about how this
benchmark together with the equal ranges method is currently used to
determine the 5-star rating system for Physician Compare, see the CY
2018 Quality Payment Program final rule (82 FR 53827 through 53829).
Additional information, including the Benchmark and Star Rating Fact
Sheet, is available on the Physician Compare Initiative website at
https://www.cms.gov/

[[Page 59914]]

Medicare/Quality-Initiatives-Patient-Assessment-Instruments/physician-
compare-initiative/. We appreciate comments received for this
section, but since no proposals were made, these comments are outside
the scope of this section and the proposed rule.
(a) Historical Data-Based Benchmarks
Benchmarks, and the resulting star rating, are valuable tools for
patients and caregivers to use to best understand the performance
information included on Physician Compare. Benchmarks can also help the
clinicians and groups reporting performance information understand
their performance relative to their peers, and therefore, help foster
continuous quality improvement. In the initial years of the Quality
Payment Program, we anticipated year-to-year changes in the measures
available. As noted, we previously finalized a policy to determine the
benchmark using the most recently available data (82 FR 53829). This
ensured that a benchmark could be calculated despite potential year-to-
year measure changes, but it also meant that the benchmark was not
known to clinicians and groups prior to the performance period.
By year 3 of the Quality Payment Program (2019 data available for
public reporting in late 2020), we expect enough year-to-year stability
in the measures available for reporting across all MIPS performance
categories to use historical data to produce a reliable and
statistically sound benchmark for most measures, by measure and
collection type (83 FR 35988). Therefore, we proposed to modify our
existing policy to use the ABC^TM methodology to determine
benchmarks for the quality, cost, improvement activities, and Promoting
Interoperability performance categories based on historical data, as
feasible and appropriate, by measure and collection type beginning with
year 3 of the Quality Payment Program (2019 data available for public
reporting in late 2020) (83 FR 35988). Specifically, benchmarks would
be based on performance data from a baseline period or, if such data is
not available, performance data from the performance period. The
baseline period would be the 12-month calendar year that is 2 years
prior to the applicable performance period. The benchmarks would be
published prior to the start of the performance period, as technically
feasible. For example, for the CY 2019 performance period, the
benchmark developed using the ABC^TM methodology would be
calculated using CY 2017 performance period data and would be published
by the start of CY 2019, as feasible and appropriate. If historical
data is not available for a particular measure, we would indicate that
and calculate the benchmark using performance data from the performance
period. In this example, we would use CY 2019 performance period data
to calculate the benchmark for CY 2019 performance period measures, as
needed. This approach of utilizing historical data would be consistent
with how the MIPS benchmarks are calculated for purposes of scoring the
quality performance category. But, most importantly, this approach
would provide eligible clinicians and groups with valuable information
about the benchmark to meet to receive a 5-star rating on Physician
Compare before data collection starts for the performance period (83 FR
35988). We requested comment on this proposal.
The following is a summary of the comments we received regarding
our proposal to modify our existing policy to use the ABC^TM
methodology to determine benchmarks for the quality, cost, improvement
activities, and Promoting Interoperability performance categories based
on historical data, as feasible and appropriate, by measure and
collection type beginning with year 3 of the Quality Payment Program
(2019 data available for public reporting in late 2020) and our
responses.
Comment: Two commenters supported using benchmarks based on
performance from a prior period so that clinicians are able to
understand how their measure scores will translate into a 5-star
rating. One commenter cautioned that historical benchmarks may penalize
those clinicians who successfully managed costs at the onset of the
benchmark while inadvertently incentivizing high spenders. Another
commenter questioned whether there was enough stability year-to-year in
MIPS to create valid and reliable benchmarks. Another commenter noted
concern that historical benchmarks would be based on data from a small
number of clinicians from various legacy programs such as the Physician
Quality Reporting System (PQRS). Another commenter cautioned that CMS
needs to consider certain clinicians' ability to affect quality and
cost when treating patients. One commenter recommended we postpone
using benchmarks for measures with no historical data, for example, a
new MIPS measure with no performance data from a prior performance
year.
Response: Regarding the concern that historical benchmarks would be
based on data from a small number of clinicians from various legacy
programs such as the PQRS, we wish to clarify that only historical MIPS
data will be used to create benchmarks; for example, year 3, which is
2019 data available for public reporting in late 2020, would use year 1
(CY 2017) MIPS data. Additionally, since these benchmarks will be based
on the MIPS performance information that eligible clinicians choose to
report, we assume that these measures, upon which the benchmarks will
be based, reflect the areas in which eligible clinicians and groups
believe they can most affect quality of care furnished. Since we are
finalizing that we will not publicly report first year measures for the
first 2 years they are in the program, new measures, which have no
prior MIPS performance data, would not be available for public
reporting until the third year they are in use, at which point there
should be historical data upon which to set a historical benchmark if
eligible clinicians and groups reported them. If, however, a measure
does not meet our public reporting standards, for example due to lack
of performance data available or insufficient sample size, then the
measure would not be available for public reporting, and would not need
a benchmark. Regarding the concern about stability of data, we do
believe that if a measure is in use for multiple years of MIPS that the
performance should stabilize. We do not expect that clinicians and
groups who manage costs effectively in 2017 should suffer a penalty by
comparing their 2019 data to 2017 benchmarks. We appreciate the comment
about high spenders and will plan to analyze impact. That said, we
appreciate the concerns raised and will continuously evaluate the data
against our public reporting standards for year-to-year stability. We
will also monitor whether the historical benchmarking approach
inadvertently creates negative incentives, though early testing has not
shown this to be the case. Regarding the suggestion to postpone using
benchmarks for measures without historical data, we disagree and
believe it is important for website users to understand clinician
performance in a meaningful way. Our testing and experience to date has
shown that the next best way to create benchmarks for information
reported on Physician Compare, in the absence of historical data, is by
using information from the most recent performance period.
After consideration of the comments, we are finalizing our proposal
to modify our existing policy to use the ABC^TM methodology
to determine benchmarks for the quality, cost, improvement activities,
and Promoting Interoperability performance categories

[[Page 59915]]

based on historical data, as feasible and appropriate, by measure and
collection type beginning with year 3 of the Quality Payment Program
(2019 data available for public reporting in late 2020). Specifically,
benchmarks will be based on performance data from a baseline period or,
if such data is not available, performance data from the performance
period. The baseline period will be the 12-month calendar year that is
2 years prior to the applicable performance period. The benchmarks will
be published prior to the start of the performance period, as
technically feasible.
(b) QCDR Measure Benchmarks
Currently, only MIPS measures are star rated on Physician Compare.
QCDR measures, as that term is used in Sec. 414.1400(e), are publicly
reported as percent performance rates. As more QCDR measure data is
available for public reporting, and appreciating the value of star
rating the measures presented to website users, we believe star rating
the QCDR measures will greatly benefit patients and caregivers as they
work to make informed health care decisions. Particularly in the
quality performance category, we believe that reporting all measure
data in the same way will ease the burden of interpretation placed on
site users and make the data more useful to them. Therefore, we
proposed (83 FR 35988 through 35989) to further modify our existing
policy to extend the use of the ABC^TM methodology and equal
ranges method to determine, by measure and collection type, a benchmark
and 5-star rating for QCDR measures, as that term is used in proposed
Sec. 414.1400(b)(3), as feasible and appropriate, using current
performance period data in year 2 of the Quality Payment Program (2018
data available for public reporting in late 2019), and using historical
benchmark data when possible as proposed above, beginning with year 3
of the Quality Payment Program (2019 data available for public
reporting in late 2020). We requested comment on this proposal.
The following is a summary of the comments we received to further
modify our existing policy to extend the use of the ABC^TM
methodology and equal ranges method to determine, by measure and
collection type, a benchmark and 5-star rating for QCDR measures and
our responses.
Comment: One commenter supported using the ABC^TM
methodology to create a benchmark for MIPS and QCDR measures, as well
as creating a 5-star rating for QCDR measures, beginning with year 3 of
the Quality Payment Program. Several commenters expressed concern about
QCDR benchmarks, noting that measure scores could be misinterpreted on
Physician Compare, particularly if the ABC^TM methodology is
used, since it may differ from the QCDR's own rating methodology and
further confuse patients. One commenter also noted that use of the
ABC^TM methodology for QCDR measures would cause clinician
confusion and potentially misrepresent clinicians in the public domain
if it results in benchmarks that are also different from the ones used
in the MIPS scoring methodology. Another commenter noted the sample
size for some QCDR measures will be too small for public reporting and
encouraged CMS to work with QCDR measure owners in establishing
benchmarks for QCDR measures.
Response: We reiterate our belief that star rating the QCDR
measures will greatly benefit patients and caregivers. Because the
QCDRs do not uniformly measure performance and each uses their own
methodology, as commenters pointed out, in our experience it makes it
more difficult for patients to use this information to make informed
healthcare decisions. Regarding the concern about differences in MIPS
scoring benchmarks and public reporting benchmarks, we note that we
will continue to evaluate approaches to alignment, but reiterate that
it is not always necessary or ideal to use the same methodology for
scoring and public reporting given the unique goals of each. QCDR
measures will undergo the same statistical testing as other measures do
to ensure they meet our public reporting standards before they are
publicly reported, and this testing does account for sample size
concerns.
After consideration of the comments, we are finalizing our proposal
to further modify our existing policy to extend the use of the
ABC^TM methodology and equal ranges method to determine, by
measure and collection type, a benchmark and 5-star rating for QCDR
measures, as that term is used in proposed Sec. 414.1400(b)(3), as
feasible and appropriate. This benchmark will use current performance
period data in year 2 of the Quality Payment Program (2018 data
available for public reporting in late 2019), and using historical
benchmark data when possible as proposed above, beginning with year 3
of the Quality Payment Program (2019 data available for public
reporting in late 2020).
(7) Voluntary Reporting
In the CY 2018 Quality Payment Program final rule (82 FR 53830), we
finalized a policy to make available for public reporting all data
submitted voluntarily across all MIPS performance categories,
regardless of collection type, by eligible clinicians and groups that
are not subject to the MIPS payment adjustments, as technically
feasible, for all future years. If an eligible clinician or group that
is not subject to the MIPS payment adjustment chooses to submit data on
quality, cost (if applicable), improvement activities, or Promoting
Interoperability, these data are available for public reporting. We
also finalized that during the 30-day preview period, these eligible
clinicians and groups may opt out of having their data publicly
reported on Physician Compare (82 FR 53830). If these eligible
clinicians and groups do not opt out during the 30-day preview period,
their data will be available for inclusion on Physician Compare if the
data meet all public reporting standards at Sec. 414.1395(b).
(8) APM Data
In the CY 2018 Quality Payment Program final rule (82 FR 53830), we
finalized a policy to publicly report the names of eligible clinicians
in Advanced APMs and the names and performance of Advanced APMs and
APMs that are not considered Advanced APMs related to the Quality
Payment Program, such as Track 1 Shared Savings Program Accountable
Care Organizations (ACOs), as technically feasible, for all future
years. We also finalized a policy to link clinicians and groups and the
APMs they participate in on Physician Compare, as technically feasible.
4. Overview of the APM Incentive
a. Overview
Section 1833(z) of the Act requires that an incentive payment be
made (or, in years after 2025, a different PFS update) to QPs for
achieving threshold levels of participation in Advanced APMs. In the CY
2017 Quality Payment Program final rule (81 FR 77399 through 77491), we
finalized the following policies:
Beginning in payment year 2019, if an eligible clinician
participated sufficiently in an Advanced APM during the QP Performance
Period, that eligible clinician may become a QP for the year. Eligible
clinicians who are QPs are excluded from the MIPS reporting
requirements for the performance year and payment adjustment for the
payment year.
For payment years from 2019 through 2024, QPs receive a
lump sum incentive payment equal to 5 percent of their prior year's
estimated aggregate payments for Part B covered

[[Page 59916]]

professional services. Beginning in payment year 2026, QPs receive a
higher update under the PFS for the year than non-QPs.
For payment years 2019 and 2020, eligible clinicians may
become QPs only through participation in Advanced APMs.
For payment years 2021 and later, eligible clinicians may
become QPs through a combination of participation in Advanced APMs and
Other Payer Advanced APMs (which we refer to as the All-Payer
Combination Option).
In the CY 2018 Quality Payment Program final rule (82 FR 53832
through 53895), we finalized clarifications, modifications, and
additional details pertaining to Advanced APMs, Qualifying APM
Participant (QP) and Partial QP determinations, Other Payer Advanced
APMs, Determination of Other Payer Advanced APMs, Calculation of All-
Payer Combination Option Threshold Scores and QP Determinations, and
Physician-Focused Payment Models (PFPMs). In the CY 2019 PFS proposed
rule (83 FR 35989 through 36006), we proposed clarifications and
modifications to policies that we previously finalized pertaining to
Advanced APMs, QP and Partial QP determinations, Other Payer Advanced
APMs, Determination of Other Payer Advanced APMs, and the Calculation
of All-Payer Combination Option Threshold Scores and QP Determinations.
In this CY 2019 PFS final rule, we respond to public comments on those
proposals and announce our final policies.
The following is a summary of the general public comments received
on Advanced APMs and our responses:
Comment: Many commenters encouraged us to accelerate our efforts to
develop more Advanced APM opportunities for clinicians. These
commenters noted that Advanced APMs have great potential to incentivize
high-quality and coordinated care while driving down overall costs, and
encouraged us to continue developing Advanced APMs to offer clinicians
more opportunity to participate in value-based payment and care
delivery. Some commenters noted concern that no progress has been made
in creating more opportunities for specialists and non-physician
professionals to participate in Advanced APMs. The commenters
encouraged CMS to develop Advanced APMs that provide opportunities for
specialists and non-physician professionals, and to create additional
pathways for specialists and non-physician professionals to
meaningfully participate in existing Advanced APMs.
Response: We agree that APMs represent an important step forward in
our efforts to move our healthcare system from volume-based to value-
based care. We note that in 2018 a number of additional Advanced APM
opportunities were made available, including the introduction of the
Medicare ACO Track 1+ Model, and the introduction of new participants
into some existing Advanced APMs, such as the Next Generation ACO Model
and Comprehensive Primary Care Plus (CPC+) Model. In 2019, there will
be even more available Advanced APM opportunities including the Bundled
Payments for Care Improvement Advanced Model, which began in October
2018, and the Maryland Total Cost of Care (which includes the Care
Redesign Program and the Maryland Primary Care Program). Additionally,
we are in the process of developing several new APMs and Advanced APMs,
and continue to work with stakeholders on new model concepts.
Comment: Some commenters suggested CMS establish a clear pathway
for clinicians to transition from MIPS to MIPS APMs and then to
Advanced APMs. The commenters noted that MIPS APMs represent a stepping
stone between MIPS and Advanced APMs providing clinicians a necessary
glide path into risk-based contracts.
Response: The Quality Payment Program represents a significant
opportunity to collaborate with the clinical community to advance
policy that pays for what works--both for clinicians and patients--to
create a simpler, sustainable Medicare program. We believe that the
Quality Payment Program provides new opportunities to improve care
delivery by supporting and rewarding clinicians as they find new ways
to engage patients, families, and caregivers and to improve care
coordination and population health management. In addition, we believe
that by developing a program that is flexible instead of one-size-fits-
all, clinicians will be able to choose to participate in a way that is
best for them, their practice, and their patients. For clinicians
interested in APMs, including MIPS APMs and Advanced APMs, we believe
that by setting ambitious yet achievable goals, eligible clinicians
will move with greater certainty toward these new approaches that
incentivize the delivery of high-value care.
We will continue to reach out to the clinician community and others
to partner in the development of ongoing education, support, and
technical assistance materials and activities to help clinicians
understand Quality Payment Program requirements, how to use available
tools to enhance their practices, improve quality, reduce cost, and
progress to participation in APMs and Advanced APMs if that is the best
choice for their practice.
Comment: Many commenters requested that we implement and test new
models recommended by the Physician-Focused Payment Model Technical
Advisory Committee (PTAC). The commenters noted that the stakeholder
community is also well aware the Department has not selected any PTAC
recommended models for testing. Specifically, the commenters noted that
the PTAC had received 27 proposals for new physician-focused payment
models, 15 of which have been reviewed by the PTAC with comments and
recommendations sent to the Secretary. Of those, the commenters stated
that 10 proposals were recommended favorably with six recommended for
limited scale testing and four recommended for implementation, but the
agency has taken no action to test or implement any of the recommended
models.
Some commenters suggested we provide more direct, regular feedback
to the PTAC and stakeholders to ensure they can address concerns and
shortcomings earlier in the development process, so that the PTAC
comment and recommendation process can yield physician-led APMs that
will be tested and implemented. The commenters also requested that we
provide technical assistance to stakeholders working to develop
proposals for the PTAC, and specifically that we make claims data
available to allow for more detailed financial modeling to be part of
the development process.
Many commenters requested that we establish a clear process and
timeline for responding to PTAC proposals in the future. The commenters
suggested that a 60-day window from the date that the Secretary
receives a recommendation from the PTAC would be appropriate.
Response: We believe that PTAC can help us make the shift from a
healthcare system that pays for volume to one that pays for value. The
commitment to health care payment innovation by the PTAC and the
broader stakeholder community is evident in the number and types of
specialties represented in the proposals being submitted to PTAC. CMS'
Center for Medicare and Medicaid Innovation (CMS Innovation Center)
staff have met with stakeholders about proposed models, including some
stakeholders that have submitted proposed physician-focused payment
models to the PTAC.

[[Page 59917]]

We note that while it seems unlikely that all of the features of
any PTAC-reviewed proposed model will be tested exactly as presented in
the proposal, certain features of proposed models may be incorporated
into new or existing models. As the CMS Innovation Center launches new
value-based payment and service delivery models, the PTAC's critical
review of proposals will be a valuable resource. Additionally, the CMS
Innovation Center will further engage with stakeholders that have
submitted proposals related to new or existing models to leverage their
experiences in the field.
While we will not provide technical assistance to individual
stakeholders before they submit proposals, we encourage potential
submitters to review the detailed responses from the Secretary to past
comments and recommenations from the PTAC to guide development of their
proposals. We also encourage stakeholders designing proposals to review
the data resources available on the Office of the Assistance Secretary
for Planning and Evaluation (ASPE) website at https://aspe.hhs.gov/resources-public-comment-physician-focused-payment-model-technical-advisory-committee. Lastly, available from the CMS Innovation Center
website is a toolkit for Alternative Payment Model Design (APM Toolkit)
to serve as a resource for any entities or individuals interested in
developing ideas for APMs (https://www.cms.gov/Medicare/Quality-Payment-Program/Resource-Library/Alternative-Payment-Model-APM-Design-Toolkit.pdf provides a detailed and comprehensive set of resources to
help design an APM).
We note that PTAC meets on a periodic basis to review proposals for
physician-focused payment models submitted by individuals and
stakeholder entities. The PTAC prepares comments and recommendations on
proposals that are received, determining whether such models meet the
criteria established by the Secretary for physician-focused payment
models in the CY 2017 Quality Payment Program final rule with comment
period (81 FR 77008, 77496-77499) and codified at Sec. 414.1465. The
PTAC's comments and recommendations generally must be discussed during
their public meetings and must be submitted to the Secretary.
Subsequently, the Secretary reviews the comments and recommendations
submitted by PTAC and posts a detailed response to these
recommendations on the CMS Innovation Center website at https://innovation.cms.gov/initiatives/pfpms/. Given this standard timeline, we
do not believe it would be realistic to set a strict 60-day timeframe
for responding to physician-focused payment models recommended by the
PTAC. As discussed in the CY 2018 Quality Payment Program final rule,
the variation in the number and nature of proposals makes it difficult
to establish such a deadline. However, HHS will continue to make every
effort to respond expeditiously to the PTAC's comments and
recommendations.
b. Terms and Definitions
In the CY 2019 PFS proposed rule, we explained that as we continue
to develop the Quality Payment Program, we have identified the need to
propose changes to some of the previously finalized definitions. A
complete list of the original definitions is available in the CY 2017
Quality Payment Program final rule (81 FR 77537 through 77540).
In the CY 2018 Quality Payment Program final rule, to consolidate
our regulations and avoid unnecessarily defining a term, we finalized
removal of the defined term for ``Advanced APM Entity'' in Sec.
414.1305 and replaced instances of that term throughout the regulation
with ``APM Entity.'' Similarly, we finalized replacing ``Advanced APM
Entity group'' with ``APM Entity group'' where it appears throughout
our regulations (82 FR 53833). We noted that these changes were
technical and had no substantive effect on our policies.
In the CY 2019 PFS proposed rule, to further consolidate our
regulations and to clarify any potential ambiguity, we proposed to
revise the definition of Qualifying APM Participant (QP) at Sec.
414.1305 to provide that a QP is an eligible clinician determined by
CMS to have met or exceeded the relevant QP payment amount or QP
patient count threshold for the year based on participation in or with
an APM Entity that is participating in an Advanced APM. The current
definition of QP is based on an eligible clinician's participation in
an Advanced APM Entity, which no longer is a defined term. Simply
replacing the term ``Advanced APM Entity'' with the term ``APM
Entity,'' as we had in the CY 2018 Quality Payment Program final rule,
does not fully convey the definition of QP because, as noted at the
time, an APM Entity can participate in an APM that is, or is not, an
Advanced APM; and QP status is attainable only through participation in
an Advanced APM (82 FR 53833). Again we note that this proposed change
is technical and will not have a substantive effect on our policies.
We solicited comments on this proposal.
We did not receive any comments in response to this proposal.
We are finalizing our proposal to revise the definition of
Qualifying APM Participant (QP) at Sec. 414.1305 to provide that a QP
is an eligible clinician determined by CMS to have met or exceeded the
relevant QP payment amount or QP patient count threshold for the year
based on participation in or with an APM Entity that is participating
in an Advanced APM.
c. Advanced APMs
(1) Overview
In the CY 2017 Quality Payment Program final rule (81 FR 77408), we
finalized the criteria that define an Advanced APM based on the
requirements set forth in sections 1833(z)(3)(C) and (D) of the Act. An
Advanced APM is an APM that:
Requires its participants to use certified EHR technology
(CEHRT) (81 FR 77409 through 77414);
Provides for payment for covered professional services
based on quality measures comparable to measures under the quality
performance category under MIPS (81 FR 77414 through 77418); and
Either requires its participating APM Entities to bear
financial risk for monetary losses that are in excess of a nominal
amount, or is a Medical Home Model expanded under section 1115A(c) of
the Act (81 FR 77418 through 77431). We refer to this criterion as the
financial risk criterion.
(2) Summary of Proposals
In the CY 2019 PFS proposed rule (83 FR 35989-35992), we included
the following proposals, each of which is discussed in further detail
below:
Use of CEHRT
We proposed to revise Sec. 414.1415(a)(i) to specify that
an Advanced APM must require at least 75 percent of eligible clinicians
in each APM Entity use CEHRT as defined at Sec. 414.1305 to document
and communicate clinical care with patients and other health care
professionals.
MIPS-Comparable Quality Measures
We proposed to revise Sec. 414.1415(b)(2) to clarify,
effective January 1, 2020, that at least one of the quality measures
upon which an Advanced APM bases the payment must either be finalized
on the MIPS final list of measures, as described in Sec. 414.1330;
endorsed by a consensus-based entity; or determined by CMS to be
evidenced-based, reliable, and valid.
We also proposed to revise Sec. 414.1415(b)(3), effective
January 1, 2020, to provide that at least one

[[Page 59918]]

outcome measure, for which measure results are included as a factor
when determining payment to participants under the terms of the APM
must either be finalized on the MIPS final list of measures as
described in Sec. 414.1330, endorsed by a consensus-based entity; or
determined by CMS to be evidence-based, reliable, and valid.
Bearing Financial Risk for Monetary Losses
We proposed to revise Sec. 414.1415(c)(3)(i)(A) to
maintain the generally applicable revenue-based nominal amount standard
at 8 percent of the average estimated total Medicare Parts A and B
revenue of all providers and suppliers in participating APM Entities
for QP Performance Periods 2021 through 2024.
(3) Use of CEHRT
(a) Overview
In the CY 2017 Quality Payment Program final rule, we finalized
that an Advanced APM must require at least 50 percent of eligible
clinicians in each APM Entity to use CEHRT as defined at Sec. 414.1305
to document and communicate clinical care with patients and other
health care professionals. Further, we proposed but did not finalize an
increase to the requirement wherein Advanced APMs must require 75
percent CEHRT use in the subsequent year. Instead we maintained the 50
percent CEHRT use requirement for the second performance year and
beyond and indicated that we would consider making any potential
changes through future rulemaking (81 FR 77412).
(b) Increasing the CEHRT Use Criterion for Advanced APMs
In the CY 2019 PFS proposed rule, we proposed that, beginning for
CY 2019, to be an Advanced APM, the APM must require at least 75
percent of eligible clinicians in each APM Entity use CEHRT as defined
at Sec. 414.1305 to document and communicate clinical care with
patients and other health care professionals.
According to data collected by the Office of the National
Coordinator for Health Information Technology (ONC), over 3 in 4
office-based physicians adopted a certified EHR in CY 2015,\32\ and
approximately 9 in 10 clinicians have 2015 Edition certified technology
available from their EHR developer.\33\ Additionally, in response to
the CY 2017 Quality Payment Program proposed rule, commenters
encouraged us to raise the CEHRT use criterion to 75 percent (see 81 FR
77411). We believe that this proposed change aligns with the increased
adoption of CEHRT among providers and suppliers that is already
happening, and will encourage further CEHRT adoption. We further
believe that most existing Advanced APMs already include provisions
that would require participants to adhere to the level of CEHRT use
specified in our regulations, and therefore this increase will not
negatively impact the Advanced APM status of those APMs.
---------------------------------------------------------------------------

\32\ Office of the National Coordinator for Health Information
Technology. 'Office-based Physician Electronic Health Record
Adoption,' Health IT Quick-Stat #50. dashboard.healthit.gov/quickstats/pages/physician-ehr-adoption-trends.php. December 2016.
\33\ Office of the National Coordinator for Health Information
Technology. '2015 Edition Market Readiness for Hospitals and
Clinicians,' Health IT Quick-Stat #55. dashboard.healthit.gov/quickstats/pages/2015-edition-market-readiness-hospitals-clinicians.php. October 2018.
---------------------------------------------------------------------------

We solicited comment on this proposal.
The following is a summary of the public comments received on this
proposal and our responses:
Comment: Many commenters supported our proposal to increase the
Advanced APM minimum CEHRT use threshold from 50 percent to 75 percent
in 2019. Some commenters noted that the use of CEHRT is a fundamental
component of any Advanced APM and that such APMs are more likely to be
successful if physicians are able to receive information on their
patients in a seamless manner, as well as document and communicate
clinical care with patients and other health care professionals.
Response: We appreciate the commenters' support of our proposal to
increase the Advanced APM minimum CEHRT use threshold from 50 percent
to 75 percent beginning in 2019.
Comment: Many commenters requested that CMS not finalize the
proposed increase in the Advanced APM minimum CEHRT use threshold from
50 percent to 75 percent beginning in 2019. Some commenters stated that
such an increase could be too burdensome for some APM participants,
especially in light of the regulatory requirement to upgrade from 2014
Edition CEHRT to 2015 Edition CEHRT in CY 2019. Other commenters noted
the proposed increase could create a barrier to entry into Advanced
APMs or create additional obstacles in designing APMs targeted for
small or rural practices.
Response: We do not believe that the proposed increase in the
Advanced APM minimum CEHRT use threshold from 50 to 75 percent will be
burdensome for APM participants. As noted above, approximately 9 in 10
clinicians have 2015 Edition certified technology available from their
most recently reported EHR developer, and we believe it is appropriate
to require the use of 2015 Edition CEHRT beginning in CY 2019. Also, in
the CY 2017 Quality Payment Program final rule, we acknowledged that
eligible clinicians would be expected to upgrade from technology
certified to the 2014 Edition to technology certified to the 2015
Edition for use in 2018, and that some eligible clinicians who had not
yet adopted CEHRT may wish to delay acquiring CEHRT products until a
2015 Edition certified product is available. We also note that the
requirement to use 2015 Edition CEHRT was delayed in the CY 2018
Quality Payment Program final rule (82 FR 53671-53672), to provide
eligible clinicians an additional year to upgrade from technology
certified to the 2014 Edition to technology certified to the 2015
Edition for use in 2019. Further, we note that most current Advanced
APMs already include provisions that would require participants to
adhere to this new level of CEHRT use specified in our regulations, and
therefore this increase will not negatively impact the Advanced APM
status of those APMs. Moving forward, though, we will consider the
applicability of the CEHRT requirement for any potential models
designed specifically for small or rural practices.
Comment: Many commenters requested that we consider delaying our
proposal to increase the Advanced APM minimum CEHRT use threshold from
50 percent to 75 percent until CY 2020. Commenters stated there already
is a regulatory requirement to upgrade to 2015 edition CEHRT in CY 2019
and that clinicians participating in Advanced APMs should not be
subject to additional health information technology requirements in a
single year. Commenters also noted that maintaining the current
Advanced APM minimum CEHRT use threshold for an additional year will
allow time for organizations and clinicians to implement the upgrade to
2015 edition CEHRT and not discourage smaller practices that are in the
process of upgrading their systems from participating in Advanced APMs.
Response: We appreciate commenters' concerns, but as noted
previously in this final rule, the requirement to use 2015 Edition
CEHRT was delayed in the CY 2018 Quality Payment Program final rule (82
FR 53671 through 53672), to provide eligible clinicians an additional
year to upgrade from technology

[[Page 59919]]

certified to the 2014 Edition to technology certified to the 2015
Edition for use in 2019. We believe organizations and clinicians had
sufficient time to implement upgrades and that it is appropriate to
require the use of 2015 Edition CEHRT beginning in CY 2019. Thus, we
believe a delay in implementation of the increase in the Advanced APM
minimum CEHRT use threshold increase is unnecessary.
Comment: Many commenters requested that CMS phase in the increase
in the Advanced APM minimum CEHRT use threshold over time, or develop a
glide path more reflective of the multi-year contracting cycles of APMs
given that current contracts with Advanced APMs, were signed with the
current Advanced APM minimum CEHRT use threshold in place. Some
commenters also suggested that CMS could retain the current 50 percent
Advanced APM minimum CEHRT use threshold, but allow APM Entities to
attest that an additional percentage of eligible clinicians are either
using CEHRT or other health information technology that augments or is
an extension of CEHRT to achieve the specific goals of the APM.
Response: We reiterate that in the CY 2017 Quality Payment Program
final rule, we stated that setting the threshold at 50 percent of
eligible clinicians would allow APMs sufficient room to meet this
requirement even if the APM includes some participants who do not have
internet access, lack face-to-face interactions with patients, or are
hospital-based. At that time, we recognized commenters' concerns that
raising the threshold to 75 percent in 2018 risked creating an overly
rigorous standard for Advanced APMs and that it would be prudent to
wait until we have more information on how the threshold would impact
specific APMs, such as specialty APMs, before increasing the threshold.
As noted previously in this final rule, we now understand that
certified EHR adoption has been more widespread, and therefore do not
believe that it is necessary to phase in the increase in the Advanced
APM minimum CEHRT use threshold over time any more so than we already
have by maintaining the threshold at 50 percent for the 2017 and 2018
QP performance periods. We also note that most current Advanced APMs
already include provisions that require participants to adhere to this
new level of CEHRT use specified in our regulations, and therefore this
increase will not negatively impact the Advanced APM status of those
APMs.
Comment: One commenter suggested that CMS provide flexibility for
APM Entities participating in Advanced APMs by allowing them to include
eligible clinicians in the 75 percent threshold calculation who are
actively working with their EMR vendors to transition to the 2015
Edition CEHRT. The commenter noted that there may be instances where
EMR vendors are finalizing their certification process during the 2019
performance year, and that may prevent an APM Entity from fully
complying with the 75 percent threshold.
Response: We reiterate that the Advanced APM CEHRT use criterion
applies to APMs and the requirements they impose on participating APM
Entities, not to the individual APM Entities participating in APMs.
This means that once an APM has been determined to be an Advanced APM
(by requiring the specified percentage of eligible clinicians in each
of its participating APM Entities to use CEHRT), the methods used in
the Advanced APM to ascertain whether the required percentage of CEHRT
use is met may be unique to each APM and may not involve a threshold
calculation. We acknowledge there may be instances where EMR vendors
are finalizing their certification process, but as noted previously,
the requirement to use 2015 Edition CEHRT was delayed to provide
eligible clinicians an additional year to upgrade from technology
certified to the 2014 Edition to technology certified to the 2015
Edition for use in 2019. Therefore, we believe it is appropriate to
require the use of 2015 Edition CEHRT beginning in CY 2019.
Comment: Many commenters noted that the proposed increase in the
Advanced APM minimum CEHRT use threshold could limit the ability of
non-physician professionals, such as physical therapists, occupational
therapists, audiologists, and speech-language pathologists, to
meaningfully participate in APMs. The commenters noted that current
CEHRT requirements are designed for prescribing professionals and do
not capture tasks performed by non-physician professionals using
different types of EHRs. Specifically, the commenters stated that the
EHRs non-physician professionals often use have not been taken into
account by ONC in developing the CEHRT standards and certification
criteria, and therefore, they would not be able to meet the definition
of CEHRT required for purposes of the Advanced APM minimum CEHRT use
threshold. The commenters suggested that CMS establish a dedicated
CEHRT program for non-physician and non-prescribing professionals and
that CMS offer assistance in the form of funding and technical support
to help these types of clinicians participate in Advanced APMs.
Response: We reiterate that the Advanced APM minimum CEHRT use
threshold applies to APMs and the requirements they impose on
participating APM Entities, not to the individual APM Entities
participating in APMs. We also note that the Advanced APM minimum CEHRT
use threshold does not mean that all eligible clinicians in each
participating APM Entity are required to use CEHRT, and that the
methods used in the Advanced APM to ascertain whether the required
percentage of CEHRT use is met may be unique to each APM. This means
there can be a percentage of eligible clinicians participating in an
APM Entity who are not using CEHRT and the APM Entity will still be in
compliance with the APM's terms and conditions. Understanding this may
have a greater effect on non-physician or non-prescribing eligible
clinicians, moving forward, we will monitor this issue for new APMs and
will consider possible solutions to facilitate participation in
Advanced APMs by non-physician or non-prescribing eligible clinicians
that may not use CEHRT due to lack of certified systems for that
specific specialty.
After considering public comments, we are finalizing our proposal
that, for QP Performance Periods beginning in 2019, to be an Advanced
APM, the APM must require at least 75 percent of eligible clinicians in
each APM Entity (or, for APMs in which hospitals are the APM Entities,
each hospital, as specified in our current regulation) to use CEHRT as
defined at Sec. 414.1305 to document and communicate clinical care
with patients and other health care professionals. We are amending
Sec. 414.1414(a)(1) to reflect this change.
(4) MIPS-Comparable Quality Measures
(a) Overview
In the CY 2017 Quality Payment Program final rule, we explained
that one of the criteria for an APM to be an Advanced APM is that it
must provide for payment for covered professional services based on
quality measures comparable to measures under the performance category
described in section 1848(q)(2)(A) of the Act, which is the MIPS
quality performance category. We generally refer to these measures in
the remainder of this discussion as ``MIPS-comparable quality
measures.'' We also explained that we interpret this criterion to
require the APM to incorporate quality measure results as a factor when
determining

[[Page 59920]]

payment to participants under the terms of the APM (81 FR 77414).
In the CY 2017 Quality Payment Program proposed rule, we proposed
that to be an Advanced APM, an APM must base payment on quality
measures that are evidence-based, reliable, and valid; and that at
least one measure must be an outcome measure unless there is not an
applicable outcome measure on the MIPS quality list at the time the APM
is developed. The required outcome measure does not have to be one of
those on the MIPS quality measure list. We did not specify that the
outcome measure is required to be evidence-based, reliable, and valid.
(81 FR 28302). We finalized these policies in the CY 2017 Quality
Payment Program final rule and codified at Sec. 414.1415(b).
(b) General Quality Measures: Evidence-Based, Reliable, and Valid
In the CY 2017 Quality Payment Program final rule, we codified at
Sec. 414.1415(b)(2) that at least one of the quality measures upon
which an Advanced APM bases the payment must have an evidence-based
focus, be reliable, and valid, and meet at least one of the following
criteria: Used in the MIPS quality performance category as described in
Sec. 414.1330; endorsed by a consensus-based entity; developed under
section 1848(s) of the Act; submitted in response to the MIPS Call for
Quality Measures under section 1848(q)(2)(D)(ii) of the Act; or any
other quality measures that CMS determines to have an evidence-based
focus and to be reliable and valid.
It has come to our attention that some have interpreted Sec.
414.1415(b)(2) to mean that measures on the MIPS final list or
submitted in response to the MIPS Call for Quality Measures necessarily
are MIPS-comparable quality measures, even if they are not evidence-
based, reliable, and valid. We did not intend to imply that any measure
that was merely submitted in response to the annual call for quality
measures or developed using Quality Payment Program funding will
automatically qualify as MIPS-comparable even if the measure was never
endorsed by a consensus-based entity, adopted under MIPS, or otherwise
determined to be evidence-based, reliable, and valid. Although we
believe such measures may be evidence-based, reliable, and valid, we
did not intend to consider them so for purposes of Sec. 414.1415(b)(2)
without independent verification by a consensus-based entity, or based
on our own assessment and determination, that they are evidence-based,
reliable, and valid. We further believe the same principle applies to
Qualified Clinical Data Registry (QCDR) measures. If QCDR measures are
endorsed by a consensus-based entity they are presumptively considered
MIPS-comparable quality measures for purposes of Sec. 414.1415(b)(2);
otherwise we would have needed independent verification, or to make our
own assessment and determination, that the measures are evidence-based,
reliable, and valid before considering them to be MIPS-comparable
quality measures (see 81 FR 77415 through 77417).
Because of the potential ambiguity in the existing definition and
out of an abundance of caution to avoid any adverse impact on APM
entities, eligible clinicians, or other commenters, we have used the
more permissive interpretation of the regulation text, wherein measures
developed under section 1848(s) of the Act and submitted in response to
the MIPS Call for Quality Measures will meet the quality criterion in
implementing the program thus far, and intend to use this
interpretation for the 2019 QP Performance Period until our new
proposal described, in this final rule, is effective on January 1,
2020. Recognizing that APMs and other payer payment arrangements that
we might consider for Advanced APM and Other Payer Advanced APM
determinations are well into development for 2019, we proposed to amend
Sec. 414.1415(b)(2) to be effective as of January 1, 2020.
Specifically, we proposed that at least one of the quality measures
upon which an Advanced APM bases payment must be finalized on the MIPS
final list of measures, as described in Sec. 414.1330; be endorsed by
a consensus-based entity; or otherwise determined by CMS to be
evidenced-based, reliable, and valid.
That is, for QP Performance Period 2020 and all future QP
Performance Periods, we would treat any measure that is either included
in the MIPS final list of measures or has been endorsed by a consensus-
based entity as presumptively evidence-based, reliable, and valid. All
other measures would need to be independently determined by CMS to be
evidence-based, reliable, and valid, to be considered MIPS-comparable
quality measures.
We solicited comment on this proposal.
The following is a summary of the public comments received on this
proposal and our responses:
Comment: Many commenters supported the proposal. Some commenters
suggested that Advanced APMs should be required to include more than
one MIPS-comparable quality measure.
Response: We appreciate the commenters' support of our proposal. We
reiterate that the quality measures criterion stipulates that to be an
Advanced APM an APM must require at least one of the quality measures
upon which an Advanced APM bases payment to be MIPS-comparable. This
does not preclude an Advanced APM from including more than one MIPS-
comparable quality measure. However, we also note that under the
statute, not all quality measures under which an APM is assessed are
required to be MIPS-comparable and not all payments under the APM must
be based on MIPS-comparable quality measures. As such, we believe that
by requiring only one quality measures upon which an Advanced APM bases
payment to be MIPS-comparable, APMs have the latitude to base payment
on quality measures that meet the goals of the APM and assess the
quality of care provided to the population of patients that the APM
participants are serving.
Comment: One commenter suggested that CMS consider Core Quality
Measure Collaborative (CQMC) endorsement as meeting the criterion for a
measure being endorsed by a consensus-based entity. The commenter noted
that as more health care providers move toward the adoption of the CQMC
Core Measure Sets, using the CQMC multi-stakeholder, consensus-based
process in determining MIPS-comparable measures would further CMS's
goal of alignment between its programs and the CQMC Core Measure Sets.
Response: We note that, under MIPS, we currently try to align with
the CQMC measures as much as possible. However, for a measure to meet
the criterion of MIPS-comparable, only measures on the list of
consensus-endorsed measures maintained by the NQF will currently meet
the criterion as being endorsed by a consensus-based entity because NQF
is the consensus-based entity that endorses standardized healthcare
performance measures for CMS as defined under 1890(b)(2) and (3) of the
Act. Therefore, CQMC endorsement does not currently meet the criterion
for a measure being endorsed by a consensus-based entity.
We also note, that we believe the revised criteria for the MIPS-
comparable measures used in Advanced APMs do not prevent an APM from
using a core measure set or using measures developed and included in
other CMS programs, but instead provides the criteria for what
constitutes a MIPS-comparable measure to meet the Advanced APM
requirement (81 FR 77417). Not all quality measures upon

[[Page 59921]]

which an APM bases payment are required to be MIPS-comparable, and not
all payments under the APM must be based on MIPS-comparable measures.
However, at least some payments must be tied to MIPS-comparable
measures.
Comment: Some commenters expressed concern that designating
measures determined to be evidenced-based, reliable, and valid by CMS
as MIPS-comparable amounts to bypassing the standard vetting process of
consensus-based entities; publishing in applicable specialty-
appropriate, peer-reviewed journals; notice-and-comment rulemaking or
separate publication in the Federal Register. The commenters suggested
that all MIPS-comparable quality measures for the Advanced APM pathway
should go through a fair and standard vetting process open to the
medical profession rather than being independently determined and
approved by CMS.
Response: As finalized in the CY 2017 Quality Payment Program final
rule, we established an Innovation Center quality measure review
process for those measures that are not NQF-endorsed or included on the
final MIPS measure list. The sole purpose of this process is to assess
for purposes of the Advanced APM MIPS-comparable measure criterion
whether these measures have an evidence-based focus, and are reliable
and valid (81 FR 77418). In most instances, the Innovation Center
internal committee responsible for this review process will make this
determination for measures that were tested for use in Innovation
Center models using internal analyses and other experts to demonstrate
that the measure meets these criteria, and thus can be used as a MIPS-
comparable measure before it is considered for inclusion in MIPS or
submitted to the consensus based entity for endorsement consideration.
The Innovation Center committee is not a substitute for those existing
processes but allows the Innovation Center to innovate by using new
measures that meet the same standards as MIPS measures. Therefore, we
appreciate the commenters' concerns but do not believe that the
Innovation Center quality measure review process bypasses the currently
established vetting process for quality measures.
After considering public comments, we are finalizing our proposal
to revise Sec. 414.1415(b)(2) to clarify, effective January 1, 2020,
to clarify that at least one of the quality measures upon which an
Advanced APM bases payment must either be finalized on the MIPS final
list of measures, as described in Sec. 414.1330; endorsed by a
consensus-based entity; or determined by CMS to be evidenced-based,
reliable, and valid.
(c) Outcome Measures: Evidence-Based, Reliable, and Valid
In Sec. 414.1415(b)(3), we generally require that the measures
upon which an Advanced APM bases payment must include at least one
outcome measure, but specify that this requirement does not apply if
CMS determines that there are no available or applicable outcome
measures in the MIPS quality measure lists for the Advanced APM's first
QP Performance Period. We note that the current regulation does not
require that the outcome measure be evidence-based, reliable, and
valid. Although it was our general expectation when developing the CY
2017 Quality Payment Program final rule that outcome measures will meet
this standard, we did not explicitly include this requirement.
In the CY 2019 PFS proposed rule, we proposed to modify Sec.
414.1415(b)(3) to explicitly require that an outcome measure must be
evidence-based, reliable, and valid (unless, as specified in the
current regulation, there is no available or applicable outcome
measure), so that at least one outcome measure used for purposes of
Sec. 414.1415(b)(1) must also be:
Finalized on the MIPS final list of measures, as described
in Sec. 414.1330;
Endorsed by a consensus-based entity; or
Determined by CMS to be evidence-based, reliable, and
valid.
We proposed that this change would have an effective date of
January 1, 2020, and would specifically require that at least one
outcome measure for which measure results are included as a factor when
determining payment to participants under the terms of the APM must
also be a MIPS-comparable quality measure. This is intended to align
with our parallel proposal for the Other Payer Advanced APM criteria
that we discuss in section III.I.4.e.(3)(d)(iii) of this final rule.
We solicited comment on this proposal.
The following is a summary of the public comments received on this
proposal and our responses:
Comment: Commenters supported the proposal to explicitly require
that an outcome measure must be finalized on the MIPS final list of
measures; be endorsed by a consensus-based entity; or otherwise
determined by CMS to be evidenced-based, reliable, and valid. One
commenter noted that this proposal is reasonable given the general
growth in the use of outcome measures.
Response: We appreciate the commenters' support, but note that our
proposal does not eliminate the exception for models where there are no
available or applicable outcome measures at the performance start date
of the model.
Comment: One commenter expressed concerns with the proposal to
explicitly require that an outcome measure must be finalized on the
MIPS final list of measures; be endorsed by a consensus-based entity;
or otherwise determined by CMS to be evidenced-based, reliable, and
valid. The commenter noted that there is little variation in outcomes
for many surgical procedures as judged by existing outcome measures,
and that outcome measures alone are not sufficient to verify that the
highest quality care is made available to patients. The commenter
suggested CMS implement a framework that could provide a much clearer
picture of the quality of care provided to the patient and includes
elements such as: Standards-based facility-level verification programs;
patient reported experience and outcomes measures; and traditional
quality measures including registry and claims-based measures.
Response: We acknowledge the commenter's concerns regarding this
use of outcomes measures and appreciate the commenter's suggestions.
The Advanced APM requirement for inclusion of one MIPS-comparable
measure that is also an outcome measure does not represent a quality
measure strategy for Advanced APMs. Rather, the statute identifies
outcome measures as a priority measure type, and we wanted to encourage
the use of outcome measures for quality performance assessment in APMs.
The quality strategy for most Advanced APMs typically includes quality
and/or utilization measures that correspond with the key payment and
practice transformation activities being tested in the APM. This is why
the majority of APMs include more than just one quality measure and
many different types of quality performance measures (for example,
process, clinical outcome, patient experience of care or patient
reported outcome measures) to assess the clinical care provided by
eligible clinicians under the APM. Our goal in developing APMs is to
ensure that all patients realize better care, improved clinical
outcomes and more efficient cost-effective care. We believe our
requirement that at least one outcome measure for which measure results
are included as a factor when determining payment to participants under
the terms of the APM must also be a MIPS-

[[Page 59922]]

comparable quality measure further reinforces these goals.
Comment: One commenter expressed concern that CMS is placing too
much emphasis on outcome measures. Specifically, the commenter
suggested that CMS continue to support the use of process measures
until meaningful outcome measures are available in more specialty
areas.
Response: We note that we require only one of the quality measures
to be an outcome measure, and have established an exception for models
where there is no available or applicable outcome measure at the
performance start date of the model. As such, we do not agree that we
are emphasizing outcome measures over process measures.
After considering public comments, we are finalizing our proposal
to revise Sec. 414.1415(b)(3), effective January 1, 2020, to require
that at least one outcome measure, for which measure results are
included as a factor when determining payment to participants under the
terms of the APM, must either be finalized on the MIPS final list of
measures as described in Sec. 414.1330, endorsed by a consensus-based
entity; or determined by CMS to be evidence-based, reliable, and valid.
As specified in the current regulation, this requirement does not apply
if CMS determines that there are no available or applicable outcome
measures included in the MIPS quality measures list for the Advanced
APM's first QP Performance Period.
(5) Bearing Financial Risk for Monetary Losses
(a) Overview
In the CY 2017 Quality Payment Program final rule, we finalized the
amount of the generally applicable revenue-based nominal amount
standard at 8 percent for the first two QP Performance Periods only,
and we sought comment on what the revenue-based nominal amount standard
should be for the third and subsequent QP Performance Periods.
Specifically, we sought comment on: (1) Setting the revenue-based
standard for 2019 and later at up to 15 percent of revenue; or (2)
setting the revenue-based standard at 10 percent so long as risk is at
least equal to 1.5 percent of expected expenditures for which an APM
Entity is responsible under an APM (81 FR 77427).
In the CY 2018 Quality Payment Program final rule, we finalized our
proposal to maintain the generally applicable revenue-based nominal
amount standard at 8 percent for the 2019 and 2020 QP Performance
Periods at Sec. 414.1415(c)(3)(i)(A). We also specified that the
standard is based on the average estimated total Medicare Parts A and B
revenue of all providers and suppliers in participating APM Entities.
We stated that we will address the nominal amount standard for QP
Performance Periods after 2020 in future rulemaking (82 FR 53838).
(b) Generally Applicable Nominal Amount Standard
We proposed to amend Sec. 414.1415(c)(3)(i)(A) to maintain the
generally applicable revenue-based nominal amount standard at 8 percent
of the average estimated total Medicare Parts A and B revenue of all
providers and suppliers in participating APM Entities for QP
Performance Periods 2021 through 2024.
We solicited comment on this proposal.
The following is a summary of the public comments received on this
proposal and our responses:
Comment: Many commenters supported our proposal to maintain the 8
percent generally applicable revenue-based standard for QP performance
periods 2021-2024. Commenters noted that maintaining the 8 percent
revenue-based standard through the 2024 QP performance period will
promote consistency for participants across performance periods and
further support CMS' efforts to transition clinicians into Advanced
APMs.
Response: We appreciate the commenters' support of our proposal to
maintain the 8 percent generally applicable revenue-based standard for
QP performance periods 2021-2024.
Comment: Two commenters suggested that we limit the generally
applicable revenue-based nominal amount standard to only include the
average estimated total Part B revenue of participating providers and
suppliers in APM Entities, rather than the average estimated total Part
A and Part B revenues of providers and suppliers in APM Entities. The
commenters stated that by including Part A revenue, CMS significantly
disadvantages APM Entities, such as ACOs, that have hospital
participants. The commenters noted that the APM Incentive Payment is
based on payments for Part B covered professional services under the
Medicare PFS, and as such, recommends that we revise the generally
applicable revenue-based nominal amount standard to only consider Part
B revenue under the Medicare PFS.
Response: We note that we did not propose to make changes to the
types of revenue that are included in the generally applicable revenue-
based nominal amount standard. However, we note that we disagree that
the generally applicable revenue-based nominal amount standard should
only include Part B revenues, as many APM Entities participating in
Advanced APMs often include hospitals and other types of institutional
providers or suppliers that may receive both Part A and B revenues.
Additionally, the generally applicable revenue-based nominal amount
standard is inclusive only of the Medicare Part A and B revenues of
providers and suppliers in participating APM Entities; therefore, if
the providers and suppliers in a given APM Entity have only Medicare
Part B revenues, only such revenues will be considered.
Comment: Some commenters suggested we reconsider establishing a
separate, lower nominal amount standard for small and rural practices.
The commenters stated that a lower revenue-based nominal amount
standard is necessary to ensure that the challenging operational risks
and expenses, which put such practices at greater financial risk when
compared to larger practices, do not prevent participation in Advanced
APMs. The commenters suggested establishing a nominal amount standard
for small and rural practices that would be aligned with the Medical
Home Model nominal amount standard or set equal to the percentage of
the APM incentive payment that an eligible clinician might attain based
on their participation in an Advanced APM. The commenters noted that a
lower revenue-base nominal amount standard may encourage greater
participation in APMs by small and rural practices.
Response: We will continue to monitor the impact of the generally
applicable revenue-based nominal amount standard and Medical Home Model
nominal amount standard on small practices and those in rural areas. We
did not include any proposals in the CY 2019 PFS proposed rule
regarding a separate standard for small or rural practices, but may
consider revisiting establishing a lower revenue-based nominal amount
standard for small practices and those in rural areas in future
rulemaking.
Comment: Some commenters requested CMS consider the financial and
administrative risk that non-physician practitioners face when joining
Advanced APMs. Specifically, the commenters suggested that CMS should
adopt a more inclusive interpretation of financial risk for monetary
losses by including any losses incurred in the operation of the APM

[[Page 59923]]

Entity rather than limiting financial risk only to losses or increased
spending in the Medicare program. The commenters stated that the
magnitude of risk CMS currently requires for participation in an
Advanced APM may prevent many eligible clinicians from considering
participation in the limited Advanced APMs available.
Response: As we stated in the CY 2018 Quality Payment Program final
rule, we recognize the substantial investments that many APM Entities
make to become successful APM participants, and also the financial and
administrative burden that eligible clinicians of all types face when
deciding to join an APM Entity. Nonetheless, as we discussed in the CY
2017 Quality Payment Program final rule, we continue to believe that
there would be significant complexity involved in creating an objective
and enforceable standard for determining whether an entity's business
risk exceeds a nominal amount. We also reiterate that business risk is
generally a cost that is unrelated to performance-based payment under
an APM. No matter how well or poorly an APM Entity performs when
assessed for purposes of the APM, costs associated with business risk
are not reduced or increased correspondingly. Therefore, we maintain
our view that business risk is not analogous to performance risk in the
APM context because the costs of those activities and investments are
not incorporated into the performance-based financial calculations of
an APM, and are therefore not appropriate for consideration for
purposes of the Advanced APM financial risk criterion (81 FR 77420).
After considering public comments, we are finalizing our proposal
to revise Sec. 414.1415(c)(3)(i)(A) to maintain the generally
applicable revenue-based nominal amount standard at 8 percent of the
average estimated total Medicare Parts A and B revenue of all providers
and suppliers in participating APM Entities for QP Performance Periods
2021 through 2024. We continue to believe that 8 percent of Medicare
Parts A and B revenues of all providers and suppliers in participating
APM Entities generally represents an appropriate standard for more than
a nominal amount of financial risk at this time. We also believe that
maintaining a consistent standard for several more years will help APM
Entities to plan for multi-year Advanced APM participation. We further
believe that maintaining a consistent standard will allow us to
evaluate how APM Entities succeed within these parameters over the
applicable timeframe.
We also sought comment on whether, as APM entities and
participating eligible clinicians grow more comfortable with assuming
risk, we should consider increasing the nominal amount standard.
Specifically, we requested comments on whether we should consider
raising the revenue-based nominal amount standard to 10 percent, and
the expenditure-based nominal amount standard to 4 percent starting for
QP Performance Periods in 2025 and later.
Several comments stated we should consider raising the revenue-
based nominal amount standard to 10 percent, and the expenditure-based
nominal amount standard to 4 percent starting for QP Performance
Periods in 2025 and later. We thank commenters for their feedback and
will take this input into consideration for future years.
(6) Summary of Final Policies
Use of CEHRT
We are finalizing revisions to Sec. 414.1415(a)(i) to
specify that an Advanced APM must require at least 75 percent of
eligible clinicians in each APM Entity, or, for APMs in which hospitals
are the APM Entities, each hospital, to use CEHRT as defined at Sec.
414.1305 to document and communicate clinical care with patients and
other health care professionals.
MIPS-Comparable Quality Measures
We are finalizing revisions to clarify at Sec.
414.1415(b)(2), effective January 1, 2020, that at least one of the
quality measures upon which an Advanced APM bases the payment in
paragraph (b)(1) of this section must either be finalized on the MIPS
final list of measures, as described in Sec. 414.1330; endorsed by a
consensus-based entity; or determined by CMS to be evidenced-based,
reliable, and valid.
We are finalizing revisions at Sec. 414.1415(b)(3),
effective January 1, 2020, to provide that at least one outcome
measure, for which measure results are included as a factor when
determining payment to participants under the terms of the APM must
either be finalized on the MIPS final list of measures as described in
Sec. 414.1330, endorsed by a consensus-based entity; or determined by
CMS to be evidence-based, reliable, and valid.
Bearing Financial Risk for Monetary Losses
We are finalizing revisions at Sec. 414.1415(c)(3)(i)(A)
to maintain the generally applicable revenue-based nominal amount
standard at 8 percent of the average estimated total Medicare Parts A
and B revenue of all providers and suppliers in participating APM
Entities for QP Performance Periods 2021 through 2024.
d. Qualifying APM Participant (QP) and Partial QP Determinations
(1) Overview
We finalized policies relating to QP and Partial QP determinations
in the CY 2017 Quality Payment Program final rule (81 FR 77433 through
77450).
(2) Summary of Proposals
In the CY 2019 PFS proposed rule (83 FR 3599 through 35994), we
included the following proposals, each of which is discussed in further
detail below:
QP Performance Period
We proposed that for each of the three QP determinations,
we will allow for claims run-out for 60 days (approximately 2 months),
before calculating the Threshold Scores so that the three QP
determinations can be completed approximately 3 months after the end of
that determination time period.
Partial QP Election To Report to MIPS
We proposed that when an eligible clinician is determined
to be a Partial QP for a year at the individual eligible clinician
level, the individual eligible clinician will make an election whether
to report to MIPS. If the eligible clinician elects to report to MIPS,
they will be subject to the MIPS reporting requirements and payment
adjustment. If the eligible clinician elects not to report, they will
be excluded from the MIPS reporting requirements and payment
adjustment. In the absence of an explicit election to report to MIPS,
the eligible clinician will be excluded from the MIPS reporting
requirements and payment adjustment. This means that no actions other
than the eligible clinician's affirmative election to participate in
MIPS will result in that eligible clinician becoming subject to the
MIPS reporting requirements and payment adjustment.
(3) QP Performance Period
In the CY 2017 Quality Payment Program final rule, we finalized for
the timing of QP determinations that a QP Performance Period runs from
January 1 through August 31 of the calendar year that is 2 years prior
to the payment year (81 FR 77446-77447). During that QP Performance
Period, we will make QP determinations at three separate snapshot dates
(March 31, June 30, and August 31), each of which will be a final
determination for the eligible clinicians who are determined to be QPs.
The QP Performance Period and the three

[[Page 59924]]

separate QP determinations apply similarly for both the group of
eligible clinicians on a Participation List and the individual eligible
clinicians on an Affiliated Practitioner List.
We also finalized that for each of the three QP determinations, we
will allow for claims run-out for 3 months, or 90 days, before
calculating the Threshold Scores so that QP determinations will be
completed approximately 4 months after each snapshot date. As a result,
the last of these three QP determinations is complete on or around
January 1 of the subsequent calendar year, which is the year
immediately prior to the MIPS payment year. For most MIPS data
submission types, January 1 of the subsequent calendar year is also the
beginning of the MIPS data submission period. This way, eligible
clinicians know of their QP status prior to or near the beginning of
the MIPS data submission period and know whether they should report any
performance period data to MIPS for the applicable MIPS payment year.
Upon further consideration and based on our experience implementing
the program to date, we believe providing eligible clinicians
notification of their QP status more quickly after each of the three QP
determination snapshot dates, and prior to the beginning of the MIPS
data submission period after the last determination, will potentially
reduce burden for eligible clinicians and APM Entities while improving
their overall experience participating in the program.
We proposed that beginning in 2019 for each of the three QP
determination dates, we will allow for claims run-out for 60 days
(approximately 2 months), before calculating the Threshold Scores so
that the three QP determinations will be completed approximately 3
months after the end of that determination time period. We note that
this proposal does not affect the QP Performance Period per se, but
rather the date by which claims for services furnished during the QP
Performance Period will need to be processed for those services to be
included in calculating the Threshold Scores. To the extent that claims
are used for calculating the Threshold Scores, such claims will have to
be processed by no later than 60 days after each of the three QP
determination dates, for information on the claims to be included in
our calculations.
We solicited comment on this proposal.
The following is a summary of the public comments received on this
proposal and our responses:
Comment: Many commenters supported the proposal to allow for claims
run-out of 60 days (approximately 2 months), before calculating the QP
threshold scores so that the three QP determinations can be completed
approximately 3 months after the end of that determination time period.
Commenters noted the importance for APM Entities to have information
about their QP status as soon as possible after each snapshot to
determine if they will need to take any additional action to report to
MIPS or seek a QP determination under the All-Payer Combination Option
should they fall short of the QP thresholds under the Medicare Option.
Response: We appreciate the commenters' support of our proposal to
allow for a claims run-out of 60 days before calculating the QP
threshold scores so that the three QP determinations can be completed
approximately 3 months after the end of that determination time period.
After considering public comments, we are finalizing our proposal
that for each of the three QP determinations, we will allow for claims
run-out for 60 days (approximately 2 months), before calculating the
Threshold Scores so that the three QP determinations can be completed
approximately 3 months after the end of that determination time period.
(4) Partial QP Election To Report to MIPS
(a) Overview
Section 1848(q)(1)(C)(ii)(II) of the Act excludes from the
definition of MIPS eligible clinician an eligible clinician who is a
Partial QP for a year and who does not report on applicable measures
and activities as required under MIPS for the year. However, under
section 1848(q)(1)(C)(vii) of the Act, an eligible clinician who is a
Partial QP for a year and reports on applicable measures and activities
as required under the MIPS is considered to be a MIPS eligible
clinician for the year.
In the CY 2017 Quality Payment Program final rule, we finalized
that following a determination that eligible clinicians in an APM
Entity group in an Advanced APM are Partial QPs for a year, the APM
Entity will make an election whether to report on applicable measures
and activities as required under MIPS. If the APM Entity elects to
report to MIPS, all eligible clinicians in the APM Entity will be
subject to the MIPS reporting requirements and payment adjustments for
the relevant year. If the APM Entity elects not to report, all eligible
clinicians in the APM Entity group will be excluded from the MIPS
reporting requirements and payment adjustments for the relevant year
(81 FR 77449).
We also finalized that in cases where the Partial QP determination
is made at the individual eligible clinician level, if the individual
eligible clinician is determined to be a Partial QP, the eligible
clinician will make the election whether to report on applicable
measures and activities as required under MIPS and, as a result, be
subject to the MIPS reporting requirements and payment adjustment (81
FR 77449). If the individual eligible clinician elects to report to
MIPS, he or she will be subject to the MIPS reporting requirements and
payment adjustments for the relevant year. If the individual eligible
elects not to report to MIPS, he or she will be excluded from the MIPS
reporting requirements and payment adjustments for the relevant year.
We note that QP determinations are made at the individual eligible
clinician level when the clinician is identified as participating in an
Advanced APM on an Affiliated Practitioner List rather than a
Participation List, or when an eligible clinician is in more than one
APM Entity group in one or more Advanced APMs, and does not achieve QP
status as part of any single APM Entity group (see Sec. 414.1425(b)(2)
and (c)(4) our regulations).
We also clarified how we consider the absence of an explicit
election to report to MIPS or to be excluded from MIPS. We finalized
that for situations in which the APM Entity is responsible for making
the decision on behalf of all eligible clinicians in the APM Entity
group, the group of Partial QPs will not be considered MIPS eligible
clinicians unless the APM Entity opts the group into MIPS
participation, so that no actions other than the APM Entity's election
for the group to participate in MIPS will result in MIPS participation
(81 FR 77449).
For eligible clinicians who are determined to be Partial QPs
individually, we finalized that we will use the eligible clinician's
actual MIPS reporting activity to determine whether to exclude the
Partial QP from MIPS in the absence of an explicit election. Therefore,
if an eligible clinician who is individually determined to be a Partial
QP submits information to MIPS (not including information automatically
populated or calculated by CMS on the Partial QP's behalf), we will
consider the Partial QP to have reported, and thus to be participating
in MIPS. Likewise, if such an individual does not take any action to
submit information to MIPS, we will consider the Partial QP to have
elected to be excluded from MIPS (81 FR 77449).

[[Page 59925]]

(b) Alignment of Partial QP Election Policies
We proposed that when an eligible clinician is determined to be a
Partial QP for a year at the individual eligible clinician level, the
individual eligible clinician will make an election whether to report
to MIPS. If the eligible clinician elects to report to MIPS, they will
be subject to MIPS reporting requirements and payment adjustments. If
the eligible clinician elects to not report to MIPS, they will not be
subject to the MIPS reporting requirements and payment adjustment. If
the eligible clinician does not make any election, they will not be
subject to the MIPS reporting requirements and payment adjustment.
We note that this proposed policy change would affect only
situations where the Partial QP makes no election to either report to
MIPS or to be excluded from the MIPS reporting requirements and payment
adjustment. Under our proposed policy, all Partial QPs retain the full
right to affirmatively decide through the election process whether or
not to be subject to the MIPS reporting requirements and payment
adjustment; whereas, if the Partial QP does not make any election, they
will not be subject to the MIPS reporting requirements and payment
adjustment.
We solicited comment on this proposal.
The following is a summary of the public comments received on this
proposal and our responses:
Comment: Some commenters supported our proposal. Specifically, the
commenters supported our proposal to exclude eligible clinicians
determined to be a Partial QP for a year at the individual eligible
clinician level from the MIPS reporting requirements and payment
adjustment, in the absence of an explicit election to report to MIPS.
Commenters noted this proposal will help to avoid confusion and prevent
inadvertently subjecting eligible clinicians to MIPS reporting
requirements and payment adjustments when information has been reported
on their behalf.
Response: We appreciate the commenters' support of our proposal to
align the Partial QP election policy for eligible clinicians who are
determined to be Partial QPs individually and for eligible clinicians
who are determined to be Partial QPs at the APM Entity level.
Comment: One commenter expressed concern that our proposal may
create additional confusion for eligible clinicians. Specifically, the
commenter noted that many eligible clinicians may not be aware that
they attained Partial QP status, and that an affirmative election is
required to participate in MIPS. The commenter also noted that such
clinicians may assume that their MIPS data is being reported on their
behalf by their practice or TIN, and as a result may inadvertently
forego a potential positive MIPS payment adjustment.
The commenter suggested an alternative approach where CMS would
apply the policy which yields the most advantageous MIPS final score
and subsequently the most advantageous MIPS payment adjustment. The
commenter noted that this alternative approach would work in such a
manner that in cases where data is submitted by a Partial QP, or on
their behalf, that would earn the Partial QP a MIPS final score
resulting in a positive MIPS payment adjustment, CMS would use that
data to provide them a MIPS final score, regardless of whether they
made an election to participate in MIPS. In cases where data is
submitted by a Partial QP, or on their behalf, that would earn the
Partial QP a MIPS final score resulting in a negative MIPS payment
adjustment, CMS would not use that data to provide them a MIPS final
score, and they would be exempt from MIPS based on the Partial QP
status.
The commenter noted this alternative approach would eliminate all
potential unintended consequences and would be consistent with other
CMS policies to use data that yields the most advantageous result. The
commenter also noted the alternative approach may further incentivize
participation in APMs and reduce burden on both eligible clinicians and
CMS because eligible clinicians would no longer have to make an
election to affirmatively opt-in or opt-out of MIPS.
Response: We acknowledge that our proposal could, in certain
limited instances, create additional confusion for eligible clinicians,
particularly eligible clinicians who may not be aware that they
attained Partial QP status and an affirmative election is required for
them to participate in MIPS. However, we note that clinicians' QP
status, including Partial QP status, is accessible via the QPP
Participation Status Tool via the Quality Payment Program website at
https://qpp.cms.gov/participation-lookup. We also continue to believe
our proposed approach will allow for greater operational simplicity
while minimizing the possibility of unexpected participation in MIPS.
We reiterate that all Partial QPs retain the full right to
affirmatively decide through the election process whether or not to be
subject to the MIPS reporting requirements and payment adjustment.
After considering public comments, we are finalizing our proposal
that when an eligible clinician is determined to be a Partial QP for a
year at the individual eligible clinician level, the individual
eligible clinician will make an election whether to report to MIPS. If
the eligible clinician elects to report to MIPS, they will be subject
to the MIPS reporting requirements and payment adjustment. If the
eligible clinician elects not to report, they will be excluded from the
MIPS reporting requirements and payment adjustment. In the absence of
an explicit election to report to MIPS, the eligible clinician will be
excluded from the MIPS reporting requirements and payment adjustment.
This means that no actions other than the eligible clinician's
affirmative election to participate in MIPS would result in that
eligible clinician becoming subject to the MIPS reporting requirements
and payment adjustment.
(5) Summary of Final Policies
In this section, we are finalizing the following policies:
QP Performance Period
We are finalizing our proposal that for each of the three
QP determinations, we will allow for claims run-out for 60 days
(approximately 2 months), before calculating the Threshold Scores so
that the three QP determinations can be completed approximately 3
months after the end of that determination time period.
Partial QP Election To Report to MIPS
We are finalizing our proposal that when an eligible
clinician is determined to be a Partial QP for a year at the individual
eligible clinician level, the individual eligible clinician will make
an election whether to report to MIPS. If the eligible clinician elects
to report to MIPS, they will be subject to the MIPS reporting
requirements and payment adjustment. If the eligible clinician elects
not to report, they will be excluded from the MIPS reporting
requirements and payment adjustment. In the absence of an explicit
election to report to MIPS, the eligible clinician will be excluded
from the MIPS reporting requirements and payment adjustment. This means
that no actions other than the eligible clinician's affirmative
election to participate in MIPS would result in that eligible clinician
becoming subject to the MIPS reporting requirements and payment
adjustment.

[[Page 59926]]

e. All-Payer Combination Option
(1) Overview
Section 1833(z)(2)(B)(ii) of the Act requires that beginning in
payment year 2021, in addition to the Medicare Option, eligible
clinicians may become QPs through the Combination All-Payer and
Medicare Payment Threshold Option, which we refer to as the All-Payer
Combination Option. In the CY 2017 Quality Payment Program final rule,
we finalized our overall approach to the All-Payer Combination Option
(81 FR 77459). The Medicare Option focuses on participation in Advanced
APMs, and we make QP determinations under this option based on Medicare
Part B covered professional services attributable to services furnished
through an APM Entity. The All-Payer Combination Option does not
replace or supersede the Medicare Option; instead, it will allow
eligible clinicians to become QPs by meeting the QP thresholds through
a pair of calculations that assess a combination of both Medicare Part
B covered professional services furnished through Advanced APMs and
services furnished through Other Payer Advanced APMs. We finalized that
beginning in payment year 2021, we will conduct QP determinations
sequentially so that the Medicare Option is applied before the All-
Payer Combination Option (81 FR 77438). The All-Payer Combination
Option encourages eligible clinicians to participate in payment
arrangements that satisfy the Other Payer Advanced APM criteria with
payers other than Medicare. It also encourages sustained participation
in Advanced APMs across multiple payers.
We finalized that the QP determinations under the All-Payer
Combination Option are based on payment amounts or patient counts as
illustrated in Tables 36 and 37, and Figures 1 and 2 of the CY 2017
Quality Payment Program final rule (81 FR 77460 through 77461). We also
finalized that, in making QP determinations with respect to an eligible
clinician, we will use the Threshold Score that is most advantageous to
the eligible clinician toward achieving QP status, or if QP status is
not achieved, Partial QP status, for the year (81 FR 77475).
BILLING CODE 4120-01-P
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[GRAPHIC] [TIFF OMITTED] TR23NO18.074

[[Page 59927]]

[GRAPHIC] [TIFF OMITTED] TR23NO18.075

Unlike the Medicare Option, where we have access to all of the
information necessary to determine whether an APM meets the criteria to
be an Advanced APM, we cannot determine whether an other payer
arrangement meets the criteria to be an Other Payer Advanced APM
without receiving information about the payment arrangement from an
external source. Similarly, we do not have the necessary payment amount
and patient count information to determine under the All-Payer
Combination Option whether an eligible clinician meets the payment
amount or patient count threshold to be a QP without receiving certain
information from an external source.
In the CY 2018 Quality Payment Program final rule, we established
additional policies to implement the All-Payer Combination Option and
finalized certain modifications to our previously finalized policies
(82 FR 53844 through 53890). A detailed summary of those policies can
be found at 82 FR 53874 through 53876 and 53890 through 53891. In
relevant part, we finalized the following:
Payer Initiated Process
We finalized at Sec. 414.1445(a) and (b)(1) that certain
other payers, including payers with payment arrangements authorized
under Title XIX (the Medicaid statute), Medicare Health Plan payment
arrangements, and payers with payment arrangements aligned with a CMS
Multi-Payer Model, can request that we determine whether their other
payer arrangements are Other Payer Advanced APMs starting prior to the
2019 QP Performance Period and each year thereafter. We finalized that
Remaining Other Payers, including

[[Page 59928]]

commercial and other private payers, could request that we determine
whether other payer arrangements are Other Payer Advanced APMs starting
in 2019 prior to the 2020 QP Performance Period, and annually each year
thereafter. We generally refer to this process as the Payer Initiated
Other Payer Advanced APM Determination Process (Payer Initiated
Process), and we finalized that the Payer Initiated Process would
generally involve the same steps for each payer type for each QP
Performance Period. If a payer uses the same other payer arrangement in
other commercial lines of business, we finalized our proposal to allow
the payer to concurrently request that we determine whether those other
payer arrangements are Other Payer Advanced APMs as well. This policy
is relevant only to the initial year of Payer Initiated Other Payer
Advanced APM determinations for which these submissions can be made
only by payers with arrangements under Title XIX, Medicare Health
Plans, or arrangements aligned with CMS multi-payer models.
Eligible Clinician Initiated Process
We finalized at Sec. 414.1445(a) and (b)(2) that, through
the Eligible Clinician Initiated Process, APM Entities and eligible
clinicians participating in other payer arrangements would have an
opportunity to request that we determine for the year whether those
other payer arrangements are Other Payer Advanced APMs. The Eligible
Clinician Initiated Process can be used to submit requests for
determinations before the beginning of a QP Performance Period for
other payer arrangements authorized under Title XIX. The Eligible
Clinician Initiated Process is available for the 2019 QP Performance
Period and each year thereafter.
Submission of Information for Other Payer Advanced APM Determinations
We finalized that, for each other payer arrangement for
which a payer requests us to make an Other Payer Advanced APM
determination, the payer must complete and submit the Payer Initiated
Submission Form by the relevant Submission Deadline.
We finalized that, for each other payer arrangement for
which an APM Entity or eligible clinician requests us to make an Other
Payer Advanced APM determination, the APM Entity or eligible clinician
must complete and submit the Eligible Clinician Initiated Submission
Form by the relevant Submission Deadline.
We removed the requirement, previously established at
Sec. 414.1445(b)(3), that payers must attest to the accuracy of
information submitted by eligible clinicians, and we also removed the
related attestation requirement at Sec. 414.1460(c). Instead, we
finalized an additional requirement at Sec. 414.1445(d) that an APM
Entity or eligible clinician that submits information under Sec.
414.1445(c) must certify that, to the best of its knowledge, the
information it submits to us is true, accurate, and complete.
QP Determinations Under the All-Payer Combination Option
We finalized at Sec. 414.1440(e) that eligible clinicians
may request that we make QP determinations at the individual eligible
clinician level and that APM Entities may request that we make QP
determinations at the APM Entity level.
We finalized at Sec. 414.1440(d)(1) that we will make QP
determinations under the All-Payer Combination Option based on eligible
clinicians' participation in Advanced APMs and Other Payer Advanced
APMs for three time periods of the QP Performance Period: January 1
through March 31; January 1 through June 30; and January 1 through
August 31. We finalized that we will use patient or payment data for
the same time periods to calculate both the Medicare and the other
payer portion of the Threshold Score calculation under the All-Payer
Cominbation Option.
We finalized at Sec. 414.1440(e)(4) that, to request a QP
determination under the All-Payer Combination Option, APM Entities or
eligible clinicians must submit all of the payment amount and patient
count information sufficient for us to make QP determinations by
December 1 of the calendar year that is 2 years to prior to the payment
year, which we refer to as the QP Determination Submission Deadline.
In this section of the final rule, we address policies within the
following topics: Other Payer Advanced APM Criteria; Other Payer
Advanced APM determinations; and Calculation of the All-Payer
Combination Option Threshold Scores and QP Determinations.
(2) Summary of Proposals
In the CY 2019 PFS proposed rule (83 FR 35999-36006), we included
the following proposals, each of which is discussed below:
Other Payer Advanced APM Criteria
We proposed to change the CEHRT use criterion so that in
order to qualify as an Other Payer Advanced APM as of January 1, 2020,
the other payer arrangement must require at least 75 percent of
participating eligible clinicians in each APM Entity use CEHRT.
We proposed to allow payers and eligible clinicians to
submit evidence as part of their request for an Other Payer Advanced
APM determination that CEHRT is used by the requisite percentage of
eligible clinicians participating in the payment arrangement (50
percent for 2019, and 75 percent for 2020 and beyond) to document and
communicate clinical care, whether or not CEHRT use is explicitly
required under the terms of the payment arrangement.
We proposed the following clarification to Sec.
414.1420(c)(2), effective January 1, 2020, to provide that at least one
of the quality measures used in the payment arrangement in paragraph
(c)(1) of this regulation must be:
++ Finalized on the MIPS final list of measures, as described in
Sec. 414.1330;
++ Endorsed by a consensus-based entity; or
++ Determined by CMS to be evidenced-based, reliable, and valid.
We proposed to revise Sec. 414.1420(c)(3) to require
that, effective January 1, 2020, unless there is no applicable outcome
measure on the MIPS quality measure list, an Other Payer Advanced APM
must use an outcome measure, that must be:
++ Finalized on the MIPS final list of measures, as described in
Sec. 414.1330;
++ Endorsed by a consensus-based entity; or
++ Determined by CMS to be evidenced-based, reliable, and valid.
We also proposed to revise our regulation at Sec.
414.1420(c)(3)(i) to provide that, for payment arrangements determined
to be Other Payer Advanced APMs for the 2019 performance year that did
not include an outcome measure that is evidence-based, reliable, and
valid, and that are resubmitted for an Other Payer Advanced APM
determination for the 2020 performance year (whether for a single year,
or for a multi-year determination as proposed in section
III.I.4.e.(4)(b) of this final rule), we would continue to apply the
current regulation for purposes of those determinations. This proposed
revision also applies to payment arrangements in existence prior to the
2020 performance year that are submitted for determination to be Other
Payer Advanced APMs for the 2020 performance year and later.

[[Page 59929]]

Determination of Other Payer Advanced APMs
We proposed details regarding the Payer Initiated Process
for Remaining Other Payers. To the extent possible, we aligned the
Payer Initiated Process for Remaining Other Payers with the previously
finalized Payer Initiated Process for Medicaid, Medicare Health Plans,
and CMS Multi-Payer Models.
We proposed to eliminate the Payer Initiated Process that
is specifically for CMS Multi-Payer Models. We believe that payers
aligned with CMS Multi-Payer Models can submit their arrangements
through the Payer Initiated Process for Remaining Other Payers proposed
in section III.I.4.e.(4)(c) of this final rule, or through the Medicaid
or Medicare Health Plan payment arrangement submission processes.
Calculation of All-Payer Combination Option Threshold Scores and QP
Determinations
We proposed to add a third alternative to allow requests
for QP determinations at the TIN level in instances where all
clinicians who reassigned billing rights under the TIN participate in a
single APM Entity. We proposed to modify our regulation at Sec.
414.1440(d) by adding this third alternative to allow QP determinations
at the TIN level in instances where all clinicians who have reassigned
billing under the TIN participate in a single APM Entity, as well as to
assess QP status at the most advantageous level for each eligible
clinician.
We also clarified that, in making QP determinations using
the All-Payer Combination Option, eligible clinicians may meet the
minimum Medicare threshold using one method, and the All-Payer
threshold using the same or a different method. We proposed to codify
this clarification by adding Sec. 414.1440(d)(4).
We proposed to extend the weighting methodology that is
used to ensure that an eligible clinician does not receive a lower
score on the Medicare portion of their all-payer calculation under the
All-Payer Combination Option than the Medicare Threshold Score they
received at the APM Entity level in order to apply a similar policy to
the proposed TIN level Medicare Threshold Scores.
(3) Other Payer Advanced APM Criteria
(a) Overview
In general, our goal is to align the Advanced APM criteria under
the Medicare Option and the Other Payer Advanced APM criteria under the
All-Payer Combination Option as permitted by statute and as feasible
and appropriate. We believe this alignment helps simplify the Quality
Payment Program and encourage participation in Other Payer Advanced
APMs (82 FR 53847).
(b) Investment Payments
Some stakeholders have requested that we take into account
``business risk'' costs such as IT, personnel, and other administrative
costs associated with APM Entities' participation in Other Payer
Advanced APMs when implementing the financial risk standard. We did not
propose to modify our financial risk standard in response to this
suggestion, and note that financial risk in the context of Other Payer
Advanced APMs is defined both in the Act (at section
1833(z)(2)(B)(iii)(II)(cc) for payment years 2021 and 2022, and section
1833(z)(3)(B)(iii)(II)(cc) for subsequent years) and our regulations at
Sec. 414.1420(d) so as to require that APM Entities in the payment
arrangement must assume financial risk when actual expenditures exceed
expected expenditures. However, we note that a payment arrangement with
an other payer, like some APMs, can be structured so that the APM
provides an investment payment to the participating APM Entities to
assist with the practice transformation that may be required for
participation in the payment arrangement. This investment payment could
be structured in various ways; for example, it could be structured
similarly to the Medicare ACO Investment Model under, which expected
shared savings payment were pre-paid to encourage new ACOs to form in
rural and underserved areas and to assist existing ACOs in meeting
certain criteria; or it could be structured so that the payment is made
specifically to encourage participating APM Entities to continue to
make staffing, infrastructure, and operations investments as a means of
practice transformation; or it could have a different structure
entirely.
Although CMS did not solicit comments regarding our statement on
investment payments, the following is a summary of the public comments
we received:
Comment: Many commenters expressed concern that CMS will continue
the current policy that does not include investment payments in the
definition and calculation of risk. The commenters stated that this
approach fails to recognize the significant investment that APM
Entities and eligible clinicians make in start-up and overhead costs in
the development and operations of APMs. Some commenters suggested that
CMS should develop a method to capture and quantify such risk.
Response: We reiterate that our policy has not changed. As we
discussed in the CY 2017 Quality Payment Program final rule, we
continue to believe that there would be significant complexity involved
in creating an objective and enforceable standard for determining
whether an entity's investment risk or business risk exceeds a nominal
amount (81 FR 77420). Therefore, we maintain our view that investment
risk or business risk is not analogous to performance risk in the APM
context because the costs of those activities and investments are not
incorporated into the performance-based financial calculations of an
APM, and therefore, are not appropriate for consideration for purposes
of the Advanced APM financial risk criterion (81 FR 77420). Other Payer
Advanced APMs, like Advanced APMs, can be designed so that they include
investment payments for participants, but those investment payments
will not be considered financial risk when assessing whether a payment
arrangement meets the Other Payer Advanced APM financial risk
criterion.
(c) Use of CEHRT
(i) Overview
In the CY 2017 Quality Payment Program final rule, we finalized
that to be an Other Payer Advanced APM, the other payer arrangement
must require at least 50 percent of participating eligible clinicians
in each APM Entity, or each hospital if hospitals are the APM Entities,
to use CEHRT to document and communicate clinical care (81 FR 77465).
This CEHRT use criterion directly paralleled the criterion established
for Advanced APMs in Sec. 414.1415(a)(1)(i).
In the CY 2018 Quality Payment Program final rule, we finalized
that we would presume that an other payer arrangement meets the 50
percent CEHRT use criterion if we receive information and documentation
from the eligible clinician through the Eligible Clinician Initiated
Process showing that the other payer arrangement requires the
requesting eligible clinician to use CEHRT to document and communicate
clinical care (see Sec. 414.1445(c)(2)).
(ii) Increasing the CEHRT Use Criterion for Other Payer Advanced APMs
We proposed to change the current CEHRT use criterion for Other
Payer

[[Page 59930]]

Advanced APMs so that in order to qualify as an Other Payer Advanced
APM as of January 1, 2020, the other payer arrangement must require at
least 75 percent of participating eligible clinicians in each APM
Entity to use CEHRT; this aligns with our proposals for the CEHRT use
criterion for Advanced APMs.
According to data collected by ONC, since the CY 2017 Quality
Payment Program final rule was published, EHR adoption has been
widespread, and we want to encourage continued adoption. Additionally,
in response to the CY 2017 Quality Payment Program proposed rule
stakeholders encouraged us to raise the CEHRT use criterion to 75
percent (see 81 FR 77411). We believe that this proposed change aligns
with the increased adoption of CEHRT among providers and suppliers that
is already happening, and will encourage further CEHRT adoption. (83 FR
35990).
We solicited comment on this proposal.
The following is a summary of the public comments received in
response to our request for comment and our responses:
Comment: A few commenters supported increasing the CEHRT use
criterion as of January 1, 2020, to 75 percent of participating
eligible clinicians in each APM Entity.
Response: We appreciate the support for our proposal to change the
Other Payer Advanced APM CEHRT use criterion to 75 percent.
Comment: Many commenters expressed concern with the proposed change
to the current CEHRT use criterion stating that raising it to 75
percent of participating eligible clinicians in each APM Entity may be
too burdensome. A few commenters noted that the CEHRT use criterion
should not be increased by any amount. One commenter stated that the
CEHRT use criterion should remain at 50 percent and allow APM entities
to attest that APM participants are using health IT. Some commenters
stated the increase is premature as the All-Payer Combination Option is
beginning in 2019. Some commenters suggested that the increase in the
threshold should occur over a longer period of time to accommodate
multi-year cycles of APM contracts.
Response: We do not believe that such an increase in the Other
Payer Advanced APM minimum CEHRT use threshold will be burdensome for
APM participants. According to data collected by ONC, certified EHR
adoption has been widespread with over 3 in 4 office-based physicians
adopted a certified EHR in CY 2015, and we want to continue to
encourage such adoption and use of CEHRT. Further, regarding the
comments that the increase in the threshold should occur over a longer
period of time to accommodate multi-year cycles of APM contracts, we
remind the commenters that, although we proposed the same increase in
the Advanced APM minimum CEHRT use threshold beginning January 1, 2019,
the proposed increase for Other Payer Advanced APMs would not apply
until January 1, 2020. We believe this is a sufficient amount of lead
time, especially given the widespread adoption of EHRs.
After considering public comments, we are finalizing our proposal
to change the current CEHRT use criterion for Other Payer Advanced APMs
so that in order to qualify as an Other Payer Advanced APM as of
January 1, 2020, the other payer arrangement must require at least 75
percent of participating eligible clinicians in each APM Entity to use
CEHRT.
(iii) Evidence of CEHRT Use
In the CY 2017 Quality Payment Program final rule, we adopted a
CEHRT use criterion for Other Payer Advanced APMs that directly
paralleled the CEHRT use criterion for Advanced APMs wherein Other
Payer Advanced APMs must require at least 50 percent of eligible
clinicians in each participating APM Entity, or each hospital if
hospitals are the APM Entities, to use CEHRT to document and
communicate clinical care.
We have since heard from payers and other stakeholders that CEHRT
is often used under other payer arrangements even if it is not
expressly required under the payment arrangement. Because CEHRT use is
increasingly common among eligible clinicians, payers may not believe
it is necessary to specifically require the use of CEHRT under the
terms of an Other Payer payment arrangement.
Given this, we believe our current policy may needlessly exclude
certain existing payment arrangements that could meet the statutory
requirements for Other Payer Advanced APMs--including some where the
majority of eligible clinicians use CEHRT, even if they are not
explicitly required to do so under the terms of their payment
arrangements.
We proposed that a payer or eligible clinician must provide
documentation to CMS that CEHRT is used to document and communicate
clinical care under the payment arrangement by at least 50 percent of
eligible clinicians in 2019, and 75 percent of the eligible clinicians
in 2020 and beyond, whether or not such CEHRT use is explicitly
required under the terms of the payment arrangement. We specifically
proposed to modify the regulation at Sec. 414.1420(b) to specify that
to be an Other Payer Advanced APM, CEHRT must be used by at least 50
percent of eligible clinicians participating in the arrangement in 2019
(or, beginning in 2020, 75 percent) of such eligible clinicians).
We solicited comment on this proposal.
The following is a summary of the public comments received in
response to our request for comment and our responses:
Comment: Many commenters expressed support for CMS' proposal that a
payer or eligible clinician must provide documentation to CMS that
CEHRT is used by at least 50 percent of eligible clinicians in 2019,
and 75 percent of eligible clinicians in 2020 and beyond, whether or
not such CEHRT use is explicitly required under the terms of the
payment arrangement.
Response: We appreciate the support for our proposal to allow for
documentation that CEHRT is used at required levels by eligible
clinicians.
After considering public comments, we are finalizing our proposal
that a payer or eligible clinician must provide documentation to CMS
that CEHRT is used to document and communicate clinical care under the
payment arrangement by at least 50 percent of eligible clinicians in
2019, and 75 percent of the eligible clinicians in 2020 and beyond,
whether or not such CEHRT use is explicitly required under the terms of
the payment arrangement. Specifically, we are finalizing our proposal
to modify the regulation at Sec. 414.1420(b) to specify that to be an
Other Payer Advanced APM, CEHRT must be used by at least 50 percent of
eligible clinicians participating in the arrangement in 2019 (or,
beginning in 2020, 75 percent) of such eligible clinicians.
(d) MIPS Comparable Quality Measures
(i) Overview
In the CY 2017 Quality Payment Program final rule, we explained
that one of the criteria for a payment arrangement to be an Other Payer
Advanced APM is that it must apply quality measures comparable to those
under the MIPS quality performance category (81 FR 77465).
In the CY 2017 Quality Payment Program proposed rule, we proposed
that to be an Other Payer Advanced APM, a payment arrangement must have
quality measures that are evidence-

[[Page 59931]]

based, reliable, and valid; and that at least one measure must be an
outcome measure if there is an applicable outcome measure on the MIPS
quality measure list. We generally refer to these measures in the
remainder of this discussion as ``MIPS-comparable quality measures.''
We did not specify in our regulation that the outcome measure is
required to be evidence-based, reliable, and valid (81 FR 77466). We
finalized these policies in the CY 2017 Quality Payment Program final
rule and codified them in the regulation at Sec. 414.1420(c).
(ii) General Quality Measures: Evidence-Based, Reliable, and Valid
In the CY 2017 Quality Payment Program final rule, we codified at
Sec. 414.1420(c)(2) that at least one of the quality measures used in
the payment arrangement with an APM Entity must have an evidence-based
focus, be reliable, and valid, and meet at least one of the following
criteria:
Used in the MIPS quality performance category as described
in Sec. 414.1330;
Endorsed by a consensus-based entity;
Developed under section 1848(s) of the Act;
Submitted in response to the MIPS Call for Quality
Measures under section 1848(q)(2)(D)(ii) of the Act; or
Any other quality measures that CMS determines to have an
evidence-based focus and to be reliable and valid.
It has come to our attention that, as with the comparable policy
for Advanced APMs as discussed at 81 FR 28302, some have read the
regulation at Sec. 414.1420(c)(2) to mean that measures on the MIPS
final list or submitted in response to the MIPS Call for Quality
Measures necessarily are MIPS-comparable quality measures, even if they
have not been determined to be evidence-based, reliable, and valid. We
did not intend to imply that any measure that was merely submitted in
response to the annual call for quality measures or developed using
Quality Payment Program funding would automatically qualify as MIPS-
comparable regardless of whether the measure was endorsed by a
consensus-based entity, adopted under MIPS, or otherwise determined to
be evidence-based, reliable, and valid. While we believe such measures
may be evidence-based, reliable, and valid, we did not intend to
consider them so for purposes of Sec. 414.1420(c)(2) without
independent verification by a consensus-based entity or based on our
own assessment and determination that they are evidence-based,
reliable, and valid. We further believe the same principle applies to
QCDR measures. If QCDR measures are endorsed by a consensus-based
entity they are presumptively considered MIPS-comparable quality
measures for purposes of Sec. 414.1420(c)(2); otherwise we would have
needed independent verification, or to make our own assessment and
determination, that the measures are evidence-based, reliable, and
valid before considering them to be MIPS-comparable (see 81 FR 77415
through 77417).
Because of the potential ambiguity in the existing definition and
out of an abundance of caution in order to avoid any adverse impact on
APM entities, eligible clinicians or other stakeholders, we have used
the more permissive interpretation of the text, wherein measures
developed under section 1848(s) of the Act and submitted in response to
the MIPS Call for Quality Measures will meet the quality criterion in
implementing the program thus far, and intend to use this
interpretation for the 2019 QP Performance Period. Recognizing that
APMs and other payer arrangements that we might consider for Advanced
APM and Other Payer Advanced APM determinations are well into
development for 2019, we proposed to use this interpretation until our
new proposal described below is effective on January 1, 2020.
Therefore, at Sec. 414.1420(c)(2), we proposed, effective January
1, 2020, that at least one of the quality measures used in the payment
arrangement with an APM Entity must meet at least one of the following
criteria:
Finalized on the MIPS final list of measures, as described
in Sec. 414.1330;
Endorsed by a consensus-based entity; or
Otherwise determined by CMS to be evidenced-based,
reliable, and valid.
That is, for QP Performance Period 2020 and all future QP
Performance Periods, we would treat any measure that is either included
in the MIPS final list of measures or has been endorsed by a consensus-
based entity as presumptively evidence-based, reliable, and valid. All
other measures would need to be independently determined by CMS to be
evidence-based, reliable, and valid, in order to be considered MIPS-
comparable quality measures.
We solicited comment on this proposal.
The following is a summary of the public comments received in
response to our request for comment and our responses:
Comment: A few commenters supported the proposal that at least one
of the quality measures used in the payment arrangement with and APM
Entity must meet at least one of the three proposed criteria to assure
that it is evidence-based, reliable, and valid.
Response: We appreciate the support for our proposal.
Comment: One commenter urged CMS to include a fourth way to
determine a quality measure is ``MIPS-like'' by clarifying that all
Medicare Advantage Star Rating measures are determined to be evidence-
based, reliable, and valid by CMS. The commenter stated that these
metrics were determined by CMS to be valid and reliable enough to use
as a basis of MA plan payment.
Response: We believe that all active Medicare Advantage Star Rating
quality measures (https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovGenIn/PerformanceData.html) are evidenced-
based, reliable, and valid when used at the health plan level. However,
if a payer has changed the unit of analysis from applying it at the
health plan level to using it at the provider level, as would likely be
necessary in this context, this may have affected the reliability and
validity of the measure. As such, we believe it is important that all
such measures be independently determined by CMS to be evidenced-based,
reliable, and valid in the context of their use in the payment
arrangement in order to satisfy the Other Payer Advanced APM criterion.
We would note that this determination that a quality measure is MIPS-
comparable would be made using the information collected by CMS as part
of the data submission process for Other Payer Advanced APM
determinations.
After considering public comments, we are finalizing our proposal
to revise Sec. 414.1420(c)(2) to clarify, effective as of January 1,
2020, that at least one of the quality measures used in the payment
arrangement with an APM Entity must either be finalized on the MIPS
final list of measures, as described in Sec. 414.1330; endorsed by a
consensus-based entity; or determined by CMS to be evidenced-based,
reliable, and valid.
(iii) Outcome Measures: Evidence-Based, Reliable, and Valid
In Sec. 414.1420(c)(3), we generally require that, to be an Other
Payer Advanced APM, the payment arrangement must use an outcome measure
if there is an applicable outcome measure on the MIPS quality measure
list. We note that the current regulation does not require that the
outcome measure be evidence-based, reliable, and valid.
We proposed to revise Sec. 414.1420(c)(3), to explicitly require
that, unless there is no applicable

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outcome measure on the MIPS quality measure list, at least one outcome
measure that is used in the payment arrangement must be evidence-based,
reliable, and valid. This proposal would have an effective date of
January 1, 2020, and would specifically require that an outcome measure
must also be MIPS-comparable. This proposal aligns with the similar
proposal for Advanced APMs discussed at section III.I.4.e.(3)(d)(ii) of
this final rule, so that an outcome measure used in the payment
arrangement must also be:
Finalized on the MIPS final list of measures, as described
in Sec. 414.1330;
Endorsed by a consensus-based entity; or
Determined by CMS to be evidence-based, reliable, and
valid.
The proposal would have an effective date of January 1, 2020. This
proposed effective date is intended to provide stakeholders sufficient
notice of, and opportunity to respond to, this change in our regulation
because the current regulation does not explicitly require that an
outcomes measures must be evidence-based, reliable, and valid and, as a
result some Other Payer Advanced APMs that were submitted for
determination in CY 2018 for the CY 2019 performance year may not
include outcomes measures that are evidence-based, reliable, and valid.
We also proposed that, for such payment arrangements that are
determined to be Other Payer Advanced APMs for the 2019 performance
year and did not include an outcome measure that is evidence-based,
reliable, and valid, and that are resubmitted for an Other Payer
Advanced APM determination for the 2020 performance year (whether for a
single year, or for a multi-year determination as proposed in section
III.I.4.e.(4)(b) of this final rule), we will continue to apply the
current regulation for purposes of those determinations. Additionally,
payment arrangements in existence prior to the 2020 performance year
that are submitted for determination to be Other Payer Advanced APMs
for the 2020 performance year and later, will be assessed under the
rules of the current regulation meaning they do not need to include an
outcome measure that is evidence-based, reliable, and valid to be an
Other Payer Advanced APM. For all other payment arrangements the
proposed revised regulation would apply beginning in CY 2020.
We solicited comment on this proposal.
The following is a summary of the public comments received in
response to our request for comment and our responses:
Comment: One commenter supported the proposal that at least one
outcome measure must be among the quality measures used in the payment
arrangement with an APM Entity, and that the outcome measure must meet
at least one of the three proposed criteria to assure that it is
evidence-based, reliable, and valid.
Response: We appreciate the support for our proposal.
After considering public comments, we are finalizing our proposal
to revise Sec. 414.1420(c)(3), effective January 1, 2020, to
explicitly require that, unless there is no applicable outcome measure
on the MIPS quality measure list, at least one outcome measure that
applies in the payment arrangement must either be finalized on the MIPS
final list of measures as described in Sec. 414.1330, endorsed by a
consensus-based entity, or determined by CMS to be evidence-based,
reliable, and valid.
(e) Financial Risk for Monetary Losses
(i) Overview
In the CY 2018 Quality Payment Program final rule, we finalized our
proposal to add a revenue-based nominal amount standard to the
generally applicable nominal amount standard for Other Payer Advanced
APMs that is parallel to the generally applicable revenue-based nominal
amount standard for Advanced APMs. Specifically, we finalized that an
other payer arrangement would meet the total risk component of the
proposed nominal risk standard if, under the terms of the other payer
arrangement, the total amount that an APM Entity potentially owes the
payer or foregoes is equal to at least: For the 2019 and 2020 QP
Performance Periods, 8 percent of the total combined revenues from the
payer of providers and suppliers in participating APM Entities. This
standard is in addition to the previously finalized expenditure-based
standard. We explained that a payment arrangement would only need to
meet one of the two standards. We would use this standard only for
other payer arrangements where financial risk is expressly defined in
terms of revenue in the payment arrangement.
(ii) Generally Applicable Nominal Amount Standard
We proposed to amend Sec. 414.1420(d)(3)(i) to maintain the
generally applicable revenue-based nominal amount standard at 8 percent
of the total combined revenues from the payer of providers and
suppliers in participating APM Entities for QP Performance Periods 2019
through 2024. This change is consistent with the proposed amendment to
our regulation to maintain the generally applicable revenue-based
nominal standard at 8 percent for Advanced APMs during the same
timeframe.
We solicited comment on this proposal.
The following is a summary of the public comments received in
response to our request for comment and our responses:
Comment: Commenters expressed support for the proposal to maintain
the general applicable revenue-based nominal amount standard at 8
percent for QP Performance Periods 2021 through 2024.
Response: We appreciate the support for our proposal to maintain
the generally applicable revenue-based nominal amount standard.
After considering public comments, we are finalizing our proposal
to revise Sec. 414.1420(d)(3)(i) to maintain the generally applicable
revenue-based nominal amount standard at 8 percent of the total
combined revenues from the payer of providers and suppliers in
participating APM Entities for QP Performance Periods 2021 through
2024.
(4) Determination of Other Payer Advanced APMs
(a) Overview
In the CY 2017 Quality Payment Program final rule, we specified
that an APM Entity or eligible clinician must submit, by a date and in
a manner determined by us, information necessary to identify whether a
given payment arrangement satisfies the Other Payer Advanced APM
criteria (81 FR 77480).
In the CY 2018 Quality Payment Program final rule, we codified at
Sec. 414.1445 the Payer Initiated Other Payer Advanced APM
Determination Process and the Eligible Clinician Initiated Other Payer
Advanced APM Determination Process pertaining to the determination of
Other Payer Advanced APMs, as well as specifying the information
required for Other Payer Advanced APM determinations (82 FR 53814
through 53873).
(b) Multi-Year Other Payer Advanced APM Determinations
In the CY 2018 Quality Payment Program final rule, we finalized
that Other Payer Advanced APM determinations made in response to
requests submitted either through the Payer Initiated Other Payer
Advanced APM Determination Process (Payer Initiated Process) or the
Eligible Clinician Initiated Other Payer

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Advanced APM Determination Process (Eligible Clinician Initiated
Process) would be in effect for only one year at a time. We sought
additional comment regarding the current duration of payment
arrangements and whether creating a multi-year determination process
would encourage the creation of more multi-year payment arrangements as
opposed to payment arrangements that are for one year only. We also
sought comment on what kind of information should be submitted annually
after the first year to update an Other Payer Advanced APM
determination (82 FR 53869 through 53870).
After consideration of this feedback, we proposed to maintain the
annual submission process with the modifications outlined below for
both the Payer Initiated Process and the Eligible Clinician Initiated
Process. We proposed that beginning with the 2019 and 2020 submission
periods for Other Payer Advanced APM determinations for performance
year 2020, after the first year that a payer, APM Entity, or eligible
clinician (which we refer to as the ``requester'' in the remainder of
this discussion) submits a multi-year payment arrangement that we
determine to be an Other Payer Advanced APM for that year, the
requester would need to submit information only on changes to the
payment arrangement that are relevant to the Other Payer Advanced APM
criteria for each successive year for the remaining duration of the
payment arrangement. In the initial submission, the requester would
certify as usual that the information provided about the payment
arrangement using the Payer Initiated Process or Eligible Clinician
Initiated Process, as applicable, is true, accurate, and complete;
would authorize CMS to verify the information; and would certify that
they would submit revised information in the event of a material change
to the payment arrangement. For multi-year payment arrangements, we
proposed to require as part of the submission that the certifying
official for the requester must agree to review the submission at least
once annually, to assess whether there have been any changes to the
information since it was submitted, and to submit updated information
notifying us of any changes to the payment arrangement that would be
relevant to the Other Payer Advanced APM criteria, and thus, to our
determination of the arrangement to be an Other Payer Advanced APM, for
each successive year of the arrangement. Absent the submission by the
requester of updated information to reflect changes to the payment
arrangement, we would continue to apply the original Other Payer
Advanced APM determination for each successive year through the earlier
of the end of that multi-year payment arrangement or 5 years.
We solicited comment on this proposal.
The following is a summary of the public comments received in
response to our request for comment and our responses:
Comment: Many commenters supported the proposal that the requester
would need to submit information only on any changes to the payment
arrangement that are relevant to the Other Payer Advanced APM criteria
for each successive year for the remaining duration of the payment
arrangement.
Response: We appreciate the support for our proposal to allow for
multi-year submissions of payment arrangements.
After considering public comments, we are finalizing our proposal
to maintain the annual submission process with the modifications
outlined above for both the Payer Initiated Process and the Eligible
Clinician Initiated Process.
For multi-year payment arrangements, we proposed to require as part
of the submission that the certifying official for the requester must
agree to review the submission at least once annually, to assess
whether there have been any changes to the information since it was
submitted, and to submit updated information notifying us of any
changes to the payment arrangement that would be relevant to the Other
Payer Advanced APM criteria, and thus, to our determination of the
arrangement to be an Other Payer Advanced APM, for each successive year
of the arrangement. Absent the submission by the requester of updated
information to reflect changes to the payment arrangement, we would
continue to apply the original Other Payer Advanced APM determination
for each successive year through the earlier of the end of that multi-
year payment arrangement or 5 years.
We solicited comment on this proposal.
The following is a summary of the public comments received in
response to our request for comment and our responses:
Comment: Many commenters supported our proposal to require as part
of the submission that the certifying official for the requester must
agree to review the submission at least once annually, to assess
whether there have been any changes to the information since it was
submitted, and to submit updated information notifying us of any
changes to the payment arrangement that would be relevant to the Other
Payer Advanced APM criteria, and thus, to our determination of the
arrangement to be an Other Payer Advanced APM, for each successive year
of the arrangement. Commenters supported the proposal that this process
remain in place through the earlier of the end of the multi-payment
arrangement or 5 years.
Response: We appreciate the support for our proposal.
After considering public comments, we are finalizing our proposal
to require as part of the submission that the certifying official for
the requester must agree to review the submission at least once
annually, to assess whether there have been any changes to the
information since it was submitted, and to submit updated information
notifying us of any changes to the payment arrangement that would be
relevant to the Other Payer Advanced APM criteria, and thus, to our
determination of the arrangement to be an Other Payer Advanced APM, for
each successive year of the arrangement. Absent the submission by the
requester of updated information to reflect changes to the payment
arrangement, we will continue to apply the original Other Payer
Advanced APM determination for each successive year through the earlier
of the end of that multi-year payment arrangement or 5 years.
(c) Payer Initiated Other Payer Advanced APM Determination Process
(Payer Initiated Process)--Remaining Other Payers
In the CY 2018 Quality Payment Program final rule, we finalized
that we will allow certain other payers, including payers with payment
arrangements authorized under Title XIX, Medicare Health Plan payment
arrangements (Medicare Advantage plans, section 1876 cost plans PACE
organization operated under section 1894 of the Act, and similar plans,
other than an APM under section 1833(z)(3)(C) of the Act, that provide
Medicare benefits under demonstration or waiver authority), and payers
with payment arrangements aligned with a CMS Multi-Payer Model to use
the Payer Initiated Process to request that we determine whether their
other payer arrangements are Other Payer Advanced APMs starting prior
to the 2019 QP Performance Period and each year thereafter (82 FR
53854). We codified this policy at Sec. 414.1445(b)(1).
We also finalized that the Remaining Other Payers, including
commercial and other private payers, may request that

[[Page 59934]]

we determine whether other payer arrangements are Other Payer Advanced
APMs starting prior to the 2020 QP Performance Period and each year
thereafter (82 FR 53867).
In the CY 2019 PFS proposed rule, we proposed details regarding the
Payer Initiated Process for the Remaining Other Payers that were not
among those other payers permitted to use the Payer Initiated Process
to submit their arrangements for Other Payer Advanced APM
Determinations in 2018 (Remaining Other Payers). To the extent
possible, we are aligning the Payer Initiated Process for Remaining
Other Payers with the previously finalized Payer Initiated Process for
Medicaid, Medicare Health Plans, and CMS Multi-Payer Models.
In the CY 2018 Quality Payment Program final rule, we finalized
that the Payer Initiated Process will be voluntary for all payers (82
FR 53855). We note that the Payer Initiated Process will be similarly
voluntary for payers that were permitted to submit payment arrangements
in 2018 and for Remaining Other Payers starting in 2019.
Guidance and Submission Form: As we have for the other payers
included in the Payer Initiated Process (82 FR 53874), we intend to
make guidance available regarding the Payer Initiated Process for
Remaining Other Payers prior to their first Submission Period, which
will occur during 2019. We intend to modify the submission form (which
we refer to as the Payer Initiated Submission Form) for use by
Remaining Other Payers to request Other Payer Advanced APM
determinations, and to make this Payer Initiated Submission Form
available to Remaining Other Payers prior to the first Submission
Period. We proposed that a Remaining Other Payer will be required to
use the Payer Initiated Submission Form to request that we make an
Other Payer Advanced APM determination. We intend for the Payer
Initiated Submission Form to include questions that are applicable to
all payment arrangements and some questions that are specific to a
particular type of payment arrangement, and we intend for it to include
a way for payers to attach supporting documentation.
We solicited comment on this proposal.
The following is a summary of the public comments received in
response to our request for comment and our responses:
Comment: Commenters supported the proposal to require Remaining
Other Payers to use the Payer Initiated Submission Form to request that
CMS make an Other Payer Advanced APM determination.
Response: We appreciate the support for our proposal.
After considering public comments, we are finalizing our proposal
that Remaining Other Payers will use the Payer Initiated Submission
Form to request that CMS make an Other Payer Advanced APM
determination.
We proposed that Remaining Other Payers may submit requests for
review of multiple other payer arrangements through the Payer Initiated
Process, though we would make separate determinations as to each other
payer arrangement and a payer would be required to use a separate Payer
Initiated Submission Form for each other payer arrangement. Remaining
Other Payers may submit other payer arrangements with different tracks
within that arrangement as one request along with information specific
to each track.
We solicited comment on this proposal.
We did not receive any comment in response to this proposal.
We are finalizing our proposal that Remaining Other Payers may
submit requests for review of multiple other payer arrangements through
the Payer Initiated Process, though we would make separate
determinations as to each other payer arrangement and a payer would be
required to use a separate Payer Initiated Submission Form for each
other payer arrangement.
Submission Period: We proposed that the Submission Period for the
Payer Initiated Process for use by Remaining Other Payers to request
Other Payer Advanced APM determinations will open on January 1 of the
calendar year prior to the relevant QP Performance Period for which we
would make Other Payer Advanced APM determinations.
We solicited comment on this proposal.
The following is a summary of the public comments received in
response to our request for comment and our responses:
Comment: One commenter supported the CMS proposal that the Payer
Initiated Process for use by Remaining Other Payers to request Other
Payer Advanced APM determinations would open on January 1.
Response: We appreciate the support for our proposal.
After considering public comments, we are finalizing our proposal
that the Payer Initiated Process for use by Remaining Other Payers to
request Other Payer Advanced APM determinations would open on January
1.
The finalized timeline for the Payer Initiated Process for
Remaining Other Payers as well as the previously finalized timeline for
the Payer Initiated Process for Medicaid and Medicare Health Plans, is
summarized in Table 59 alongside the final timeline for the Eligible
Clinician Initiated Process.

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CMS Determination: Upon the timely receipt of a Payer Initiated
Submission Form, we will use the information submitted to determine
whether the other payer arrangement meets the Other Payer Advanced APM
criteria. We proposed that if we find that the Remaining Other Payer
has submitted incomplete or inadequate information, we will inform the
payer and allow them to submit additional information no later than 15
business days from the date we inform the payer of the need for
additional information. For each other payer arrangement for which the
Remaining Other Payer does not submit sufficient information in a
timely fashion, we will not make a determination in response to that
request submitted via the Payer Initiated Submission Form. As a result,
the other payer arrangement will not be considered an Other Payer
Advanced APM for the year. These determinations are final and not
subject to reconsideration.
We solicited comment on this proposal.
We did not receive any comments in response to this proposal.
We are finalizing our proposal that if we find that the Remaining
Other Payer has submitted incomplete or inadequate information, we
would inform the payer and allow them to submit additional information
no later than 15 business days from the date we inform the payer of the
need for additional information.
CMS Notification: We intend to notify Remaining Other Payers of our
determination for each request as soon as practicable after the
relevant Submission Deadline. We note that Remaining Other Payers may
submit information regarding an other payer arrangement for a
subsequent QP Performance Period even if we have determined that the
other payer arrangement is not an Other Payer Advanced APM for a prior
year.
CMS Posting of Other Payer Advanced APMs: We intend to post on the
CMS website a list (which we refer to as the Other Payer Advanced APM
List) of all other payer arrangements that we determine to be Other
Payer Advanced APMs. Prior to the start of the relevant QP Performance
Period, we intend to post a list of the payment arrangements that we
determine to be Other Payer Advanced APMs through the Payer Initiated
Process, and Other Payer Advanced APMs under Title XIX through the
Eligible Clinician Initiated Process. After the QP Performance Period,
we will update this list to include payment arrangements that we
determine to be Other Payer Advanced APMs based on other requests
through the Eligible Clinician Initiated Process. We intend to post the
list of other payer arrangements that we determine to be Other Payer
Advanced APMs through the Payer Initiated Process prior to the start of
the relevant QP Performance Period, and then to update the list to
include payment arrangements that we determine to be Other Payer
Advanced APMs based on requests received through the Eligible Clinician
Initiated Process.
(d) Payer Initiated Process--CMS Multi-Payer Models
In the CY 2018 Quality Payment Program final rule, we finalized
that beginning for the first QP Performance Period under the All-Payer
Combination Option, payers with a payment arrangement aligned with a
CMS Multi-Payer Model may request that we determine whether that
aligned payment arrangement is an Other Payer Advanced APM.
In the CY 2019 PFS proposed rule, we proposed to eliminate the
Payer Initiated Process and submission form that are specifically for
CMS Multi-Payer Models. We believe that payers aligned with CMS Multi-
Payer Models can submit their arrangements through the Payer Initiated
Process for

[[Page 59936]]

Remaining Other Payers we have proposed in section III.I.4.g.(3)(c) of
this final rule, or through the existing Medicaid or Medicare Health
Plan payment arrangement submission process, as applicable.
We solicited comment on this proposal.
We did not receive any comment in response to this proposal.
We are finalizing our proposal to eliminate the Payer Initiated
Process and submission form that are specifically for CMS Multi-Payer
Models.
(5) Calculation of All-Payer Combination Option Threshold Scores and QP
Determinations
(a) Overview
In the CY 2017 Quality Payment Program final rule, we finalized our
overall approach to the All-Payer Combination Option (81 FR 77463).
Beginning in 2021, in addition to the Medicare Option, an eligible
clinician may alternatively become a QP through the All-Payer
Combination Option, and an eligible clinician need only meet the QP
threshold under one of the two options to be a QP for the payment year
(81 FR 77459). We finalized that we will conduct the QP determination
sequentially so that the Medicare Option is applied before the All-
Payer Combination Option (81 FR 77459).
In the CY 2017 Quality Payment Program final rule, we finalized
that we will calculate Threshold Scores under the Medicare Option
through both the payment amount and the patient count methods, compare
each Threshold Score to the relevant QP and Partial QP Thresholds, and
use the most advantageous scores to make QP determinations (81 FR
77457). We finalized the same approach for the All-Payer Combination
Option wherein we will use the most advantageous method for QP
determinations with the data that has been provided (81 FR 77475).
(b) QP Determinations Under the All-Payer Combination Option
In the CY 2018 Quality Payment Program final rule, we finalized
that an eligible clinician may request a QP determination at the
eligible clinician level, and that an APM Entity may request a QP
determination at the APM Entity Level (82 FR 53880 through 53881). In
the event that we receive a request for QP determination from an
individual eligible clinician and also separately from that individual
eligible clinician's APM Entity, we would make a determination at both
levels. The eligible clinician could become a QP on the basis of either
of the two determinations (82 FR 53881).
We proposed to add a third alternative to allow requests for QP
determinations at the TIN level in instances where all clinicians who
have reassigned billing rights under the TIN participate in a single
(meaning the same) APM Entity. Therefore, this option would be
available to all TINs participating in Full TIN APMs, such as the
Medicare Shared Savings Program. It would also be available to any
other TIN for which all clinicians who have reassigned their billing
rights to the TIN are participating in the same APM Entity.
We solicited comment on this proposal.
The following is a summary of the public comments received in
response to our request for comment and our responses:
Comment: Many commenters supported the proposal to add a third
alternative to allow requests for QP determinations at the TIN level in
instances where all clinicians who have reassigned billing rights under
the TIN participate in a single APM Entity.
Response: We appreciate the support for our proposal.
After considering public comments, we are finalizing our proposal
to add a third alternative to allow requests for QP determinations at
the TIN level in instances where all clinicians who have reassigned
billing rights under the TIN participate in a single APM Entity.
We proposed that, similar to our existing policies for individual
and APM Entity requests for QP determinations under the All-Payer
Combination Option, we would assess QP status based on the most
advantageous result for each individual eligible clinician. That is, if
we receive any combination of QP determination requests (at the TIN-
level, APM Entity level, or individual level) we will make QP
assessments at all requested levels and determine QP status on the
basis of the QP assessment that is most advantageous to the eligible
clinician.
We solicited comment on this proposal.
The following is a summary of the public comments received in
response to our request for comment and our responses:
Comment: Many commenters supported the proposal to assess QP status
based on the most advantageous result for each individual eligible
clinician.
Response: We appreciate the support for our proposal.
After considering public comments, we are finalizing our proposal
to assess QP status based on the most advantageous result for each
individual eligible clinician.
(c) Use of Individual or APM Entity Information for Medicare Payment
Amount and Patient Count Calculation Under the All-Payer Combination
Option
(i) Flexibility in the Medicare Option and All-Payer Combination Option
Threshold Methods
In the CY 2018 Quality Payment Program final rule, we finalized
that when we make QP determinations at the individual eligible
clinician level, we would use the individual eligible clinician payment
amounts and patient counts for the Medicare calculations in the All-
Payer Combination Option. When we make QP determinations at the APM
Entity level, we will use APM Entity level payment amounts and patient
counts for the Medicare calculations in QP determinations under the
All-Payer Combination Option. Eligible clinicians assessed at the
individual eligible clinician level under the Medicare Option at Sec.
414.1425(b)(2) will be assessed at the individual eligible clinician
level only under the All-Payer Combination Option. We codified these
policies at Sec. 414.1440(d)(2) (82 FR 53881).
We noted in the CY 2019 PFS proposed rule that some may have read
our regulation at Sec. 414.1440(d)(2) to suggest that consistency is
required across the two thresholds requiring eligible clinicians or APM
Entities to meet the minimum Medicare threshold needed to qualify for
the All-Payer Combination Option and the All-Payer threshold using the
same method--either payment amounts or patient counts. Although we did
not directly address this specific question in our current regulation
or in prior rulemaking, we are clarifying that eligible clinicians or
APM Entities can meet the minimum Medicare threshold for the All-Payer
Combination option using one method (whichever is most favorable), and
the All-Payer threshold for the All-Payer Combination Option using
either the same, or the other method. All data submitted to us for
Other Payer Advanced APM determinations and, when applicable, QP
determinations using the All-Payer Combination Option will be
considered and evaluated; and eligible clinicians (or APM Entities or
TINs, as appropriate) may submit all data relating to both the payment
amount and patient count methods. To avoid any potential ambiguity for
the future, we proposed a change to Sec. 414.1440(d)

[[Page 59937]]

to codify this clarification. We proposed to add a new Sec.
414.1440(d)(4) to expressly allow eligible clinicians or APM Entities
to meet the minimum Medicare threshold using the most favorable of the
payment amount or patient count method, and then to meet the All-Payer
threshold using either the same method or the other method. We note
that, in the preamble in the CY 2019 PFS proposed rule, we indicated
that we would codify this proposed policy by adding a new Sec.
414.1440(d)(4) to our regulations. However, the corresponding proposed
regulation text included the proposed policy as an amendment to the
regulation text at Sec. 414.1440(d)(1). We intended to propose the
policy reflected in the propoed regulation text, and due to a clerical
error, inadvertently neglected to revise the description of the
proposal in the preamble. As such, rather than adding a new Sec.
414.1440(d)(4), we intended to propose to amend the regulation at Sec.
414.1440(d)(1) to expressly allow eligible clinicians or APM Entities
to meet the minimum Medicare threshold using the most favorable of the
payment amount or patient count method, and then to meet the All-Payer
threshold using either the same method or the other method.
We solicited comment on this proposal.
The following is a summary of the public comments received in
response to our request for comment and our responses:
Comment: Some commenters supported the proposal to allow eligible
clinicians or APM Entities to meet the minimum Medicare threshold using
the most favorable of the payment amount or patient count method, and
then to meet the All-Payer threshold using either the same method or
the other method.
Response: We appreciate the support for our proposal.
After considering public comments, we are finalizing our proposal
with the correction noted above, that we are amending the text in our
regulation at Sec. 414.1440(d)(1) to expressly allow eligible
clinicians or APM Entities to meet the minimum Medicare threshold using
the most favorable of the payment amount or patient count method, and
then to meet the All-Payer threshold using either the same method or
the other method.
(ii) Extending the Medicare Threshold Score Weighting Methodology to
TIN Level All-Payer Combination Option Threshold Score Calculations
In the CY 2018 Quality Payment Program final rule, we explained
that we recognize that in many cases an individual eligible clinician's
Medicare Threshold Scores would likely differ from the corresponding
Threshold Scores calculated at the APM Entity group level, which would
benefit those eligible clinicians whose individual Threshold Scores
would be higher than the group Threshold Scores and disadvantage those
eligible clinicians whose individual Threshold Scores are equal to or
lower than the group Threshold Scores (82 FR 53881-53882). In
situations where eligible clinicians are assessed under the Medicare
Option as an APM Entity group, and receive a Medicare Threshold Score
at the APM Entity group level, we believe that the Medicare portion of
their All-Payer calculation under the All-Payer Combination Option
should not be lower than the Medicare Threshold Score that they
received by participating in an APM Entity group.
To accomplish this outcome, we finalized a modified weighting
methodology. We finalized that when the eligible clinician's Medicare
Threshold Score calculated at the individual level would be lower than
the Medicare Threshold Score calculated at the APM Entity group level,
we would apply a weighting methodology to calculate the Threshold Score
for the eligible clinician. This methodology allows us to apply the APM
Entity group level Medicare Threshold Score (if higher than the
individual eligible clinician level Medicare Threshold Score), to the
eligible clinician, under either the payment amount or patient count
method, but weighted to reflect the individual eligible clinician's
Medicare volume. We multiply the eligible clinician's APM Entity group
Medicare Threshold Score by the total Medicare payments or patients
made to that eligible clinician as follows:
[GRAPHIC] [TIFF OMITTED] TR23NO18.077

In the CY 2019 PFS proposed rule, we proposed to extend the same
weighting methodology to TIN level Medicare Threshold Scores in
situations where a TIN is assessed under the Medicare Option as part of
an APM Entity group, and receives a Medicare Threshold Score at the APM
Entity group level. In this scenario, we believe that the Medicare
portion of the TIN's All-Payer Combination Option Threshold Score
should not be lower than the Medicare Threshold Score that they
received by participating in an APM Entity group (82 FR 53881-53882).
We note this extension of the weighting methodology would only apply to
a TIN when that TIN represents a subset of the eligible clinicians in
the APM Entity, because when the TIN and the APM Entity are the same
there is no need for this weighted methodology. We would multiply the
TIN's APM Entity group Medicare Threshold Score by the total Medicare
payments or patients for that TIN as follows:
[GRAPHIC] [TIFF OMITTED] TR23NO18.288

We proposed to calculate the TIN's Threshold Scores both on its own
and with this weighted methodology, and then use the most advantageous
score when making a QP determination. We believe that, as it does for
QP determinations made at the APM Entity level, this approach promotes
consistency between the Medicare Option and the All-Payer Combination
Option to the extent possible. Additionally, the proposed application
of this weighting approach in the case of a TIN level QP determination
would be consistent with our established policy.
We solicited comment on this proposal.
The following is a summary of the public comments received in
response to our request for comment and our responses:
Comment: Commenters supported the proposal to extend the same
weighting

[[Page 59938]]

methodology to TIN level Medicare Threshold Scores in situations where
a TIN is assessed under the Medicare Option as part of an APM Entity
group, and receives a Medicare Threshold Score at the APM Entity group
level.
Response: We appreciate support for our proposal.
After considering public comments, we are finalizing our proposal
to extend the same weighting methodology to TIN level Medicare
Threshold Scores in situations where a TIN is assessed under the
Medicare Option as part of an APM Entity group, and receives a Medicare
Threshold Score at the APM Entity group level.
(6) Summary of Final Policies
In this section, we are finalizing the following policies:
Other Payer Advanced APM Criteria:
We are finalizing our proposal to change the CEHRT use
criterion so that in order to qualify as an Other Payer Advanced APM as
of January 1, 2020, the percentage of eligible clinicians participating
in the other payer arrangement who are using CEHRT must be 75 percent.
We are finalizing our proposal to allow payers and
eligible clinicians to submit evidence as part of their request for an
Other Payer Advanced APM determination that CEHRT is used by the
requisite percentage of eligible clinicians participating in the
payment arrangement (50 percent for 2019, and 75 percent for 2020 and
beyond) to document and communicate clinical care, whether or not CEHRT
use is explicitly required under the terms of the payment arrangement.
We codifying this change at Sec. 414.1420(b).
We are finalizing the following clarification to Sec.
414.1420(c)(2), effective January 1, 2020, to provide that at least one
of the quality measures used in the payment arrangement in paragraph
(c)(1) of this regulation must be:
++ Finalized on the MIPS final list of measures, as described in
Sec. 414.1330;
++ Endorsed by a consensus-based entity; or
++ Determined by CMS to be evidenced-based, reliable, and valid.
We are finalizing our proposal to revise Sec.
414.1420(c)(3) to require that, effective January 1, 2020, unless there
is no applicable outcome measure on the MIPS quality measure list, an
Other Payer Advanced APM must use an outcome measure, that meets the
proposed criteria in paragraph (c)(2) of this regulation.
We are also finalizing our proposal at Sec.
414.1420(c)(3)(i) that, for payment arrangements determined to be Other
Payer Advanced APMs for the 2019 performance year which did not include
an outcome measure that is evidence-based, reliable, and valid, that
are resubmitted for an Other Payer Advanced APM determination for the
2020 performance year (whether for a single year, or for a multi-year
determination as proposed in section III.I.4.g.(3)(b) of this final
rule), we would continue to apply the current regulation for purposes
of those determinations. This revision also applies to payment
arrangements in existence prior to the 2020 performance year that are
submitted for determination to be Other Payer Advanced APMs for the
2020 performance year and later.
Determination of Other Payer Advanced APMs
We are finalizing details regarding the Payer Initiated
Process for Remaining Other Payers. To the extent possible, we are
aligning the Payer Initiated Process for Remaining Other Payers with
the previously finalized Payer Initiated Process for Medicaid, Medicare
Health Plans, and CMS Multi-Payer Models.
We are finalizing our proposal to eliminate the Payer
Initiated Process that is specifically for CMS Multi-Payer Models. We
believe that payers aligned with CMS Multi-Payer Models can submit
their arrangements through the Payer Initiated Process for Remaining
Other Payers that we are finalizing as described in section
III.I.4.g.(3)(c) of this final rule, or through the Medicaid or
Medicare Health Plan payment arrangement submission processes.
Calculation of All-Payer Combination Option Threshold Scores and QP
Determinations
We are finalizing our proposal to add a third alternative
to allow requests for QP determinations at the TIN level in instances
where all clinicians who reassigned billing rights under the TIN
participate in a single APM Entity. We are finalizing this proposal to
revise Sec. 414.1440(d), by adding this third alternative to allow QP
determinations at the TIN level in instances where all clinicians who
have reassigned billing under the TIN participate in a single APM
Entity, as well as to assess QP status at the most advantageous level
for each eligible clinician.
We also are finalizing our clarification that, in making
QP determinations using the All-Payer Combination Option, eligible
clinicians may meet the minimum Medicare threshold using one method,
and the All-Payer threshold using the same or a different method. We
are finalizing our proposal with a correction to codify this
clarification by amending Sec. 414.1440(d)(1).
We are finalizing our proposal to extend the same
weighting methodology to TIN level Medicare Threshold Scores in
situations where a TIN is assessed under the Medicare Option as part of
an APM Entity group, and receives a Medicare Threshold Score at the APM
Entity group level.
5. Quality Payment Program Technical Correction: Regulation Text
Changes
a. Overview
We proposed certain technical revisions to our regulations in order
to correct several technical errors and to reconcile the text of
several of our regulations with the final policies we adopted through
notice and comment rulemaking.
b. Regulation Text Changes
We proposed a technical correction to Sec. 414.1415(b)(1) of our
regulations to specify that an Advanced APM must require quality
measure performance as a factor when determining payment to
participants for covered professional services under the terms of the
APM (83 FR 36005). The addition of the word ``quality'' better aligns
with section 1833(z)(3)(D) of the Act and with the policy that was
finalized in the CY 2017 Quality Payment Program final rule (81 FR
77406), and corrects a clerical error we made in the course of revising
the text of Sec. 414.1415(b)(1) for inclusion in the CY 2017 QPP final
rule. This proposed revision would not change our current policy for
this Advanced APM criterion.
We solicited comment on this proposal.
We did not receive any comments in response to this proposal.
We are finalizing the technical correction to Sec. 414.1415(b)(1)
to specify that an Advanced APM must require quality measure
performance as a factor when determining payment to participants for
covered professional services under the terms of the APM.
We also proposed technical corrections to Sec.
414.1420(d)(3)(ii)(B) (83 FR 36005). These changes align with the
generally applicable nominal amount standard for Other Payer Advanced
APMs that was finalized in the CY 2017 Quality Payment Program final
rule, and the change to the generally applicable nominal amount
standard in the CY 2018 Quality Payment Program final rule where we
established a revenue-based nominal amount standard as part of the
Other Payer Advanced APM

[[Page 59939]]

criteria (82 FR 53849-53850). We finalized that a payment arrangement
must require APM Entities to bear financial risk for at least 3 percent
of the expected expenditures for which an APM Entity is responsible
under the payment arrangement, and that a payment arrangement's level
of marginal risk must be at least 30 percent of losses in excess of the
expected expenditures, and the maximum allowable minimum loss rate must
be 4 percent (81 FR 77471). Due to a clerical oversight, we
inadvertently published two conflicting provisions in regulation text.
At Sec. 414.1420(d)(3)(i), we correctly finalized that a payment
arrangement must require APM Entities to bear financial risk for at
least 3 percent of the expected expenditures for which an APM Entity is
responsible under the payment arrangement, and at Sec.
414.1420(d)(3)(ii)(B) we incorrectly finalized that the risk
arrangement must have a total potential risk of at least 4 percent of
expected expenditures. We are effectuating this change by removing the
Other Payer Advanced APM Criteria, Financial Risk, Generally Applicable
Nominal Amount Standard provision at Sec. 414.1420(d)(3)(ii)(B) and
consolidating Sec. 414.1420(d)(3)(ii)(A) into Sec.
414.1420(d)(3)(ii).
We solicited comment on this proposal.
The following is a summary of the public comments received in
response to our request for comment and our responses:
Comment: One commenter thanked the agency for making the technical
correction to clarify that an Other Payer payment arrangement must
require APM Entities to bear financial risk for at least 3 percent, not
4 percent.
Response: We thank the commenter for their support of this
technical correction.
After considering public comments, we are finalizing this technical
correction by removing the Other Payer Advanced APM Criteria, Financial
Risk, Generally Applicable Nominal Amount Standard provision at Sec.
414.1420(d)(3)(ii)(B) and consolidating Sec. 414.1420(d)(3)(ii)(A)
into Sec. 414.1420(d)(3)(ii).
In the CY 2017 Quality Payment Program final rule, we finalized a
capitation standard for the financial risk criterion under the Advanced
APM Criteria and the Other Payer Advanced APM Criteria, respectively.
We finalized that full capitation arrangements would meet the Advanced
APM financial risk criterion and Other Payer Advanced APM financial
risk criterion, and would not separately need to meet the generally
applicable financial risk standard and generally applicable nominal
amount standard in order to satisfy the financial risk criterion for
Advanced APMs and Other Payer Advanced APMs (81 FR 77431; 77472). We
proposed to clarify the application of the capitation standard by
revising Sec. 414.1415(c) and Sec. 414.1420(d) to refer to the full
capitation exception that is expressed in paragraphs (c)(6) and (d)(7),
respectively (83 FR 36006).
We solicited comment on this proposal.
We did not receive any comments in response to this proposal.
We are finalizing our proposal to clarify the application of the
capitation standard by revising Sec. 414.1415(c) and Sec. 414.1420(d)
to refer to the full capitation exception that is expressed in
paragraphs (c)(6) and (d)(7), respectively.
In finalizing Sec. Sec. 414.1415(c)(6) and 414.1420(d)(7), we
specified that a capitation arrangement means a payment arrangement in
which a per capita or otherwise predetermined payment is made under the
APM for all items and services for which payment is made through the
APM furnished to a population of beneficiaries, and no settlement is
performed to reconcile or share losses incurred or savings earned by
the APM Entity. This language does not completely reflect our
definition of capitation risk arrangements as discussed in the preamble
at 81 FR 77430 where we state that, ``capitation risk arrangements, as
defined here, involve full risk for the population of beneficiaries
covered by the arrangement, recognizing that it might require no
services whatsoever or could require exponentially more services than
were expected in calculating the capitation rate. . . . [a] capitation
risk arrangement adheres to the idea of a global budget for all items
and services to a population of beneficiaries during a fixed period of
time.'' Therefore, we proposed to revise these regulations to align the
Advanced APM Criteria, Financial Risk, Capitation provision at Sec.
414.1415(c)(6), and the Other Payer Advanced APM Criteria, Financial
Risk, Capitation provision at Sec. 414.1420(d)(7) with the definition
of capitation risk arrangements that we expressed in the preamble of
the CY 2017 Quality Payment Program final rule at 81 FR 77430-77431 (83
FR 36006).
We solicited comment on this proposal.
We did not receive any comments in response to this proposal.
We are finalizing our proposal to revise the Advanced APM Criteria,
Financial Risk, Capitation provision at Sec. 414.1415(c)(6), and the
Other Payer Advanced APM Criteria, Financial Risk, Capitation provision
at Sec. 414.1420(d)(7) to align with the definition of capitation risk
arrangements that we expressed in the preamble of the CY 2017 Quality
Payment Program final rule at 81 FR 77430-77431.
We also proposed a technical correction to remove the ``; or'' and
replace it with a ``.'' at Sec. 414.1420(d)(3)(i) because the
paragraph that follows that section does not specify a standard that is
necessarily an alternative to the standard under Sec.
414.1420(d)(3)(i), but rather expresses a standard that is independent
of the standard under Sec. 414.1420(d)(3)(i) (83 FR 36006). As
indicated in the CY 2018 Quality Payment Program final rule at 82 FR
53849-53850, where we established a revenue-based nominal amount
standard for Other Payer Advanced APMs, in order to meet the generally
applicable nominal amount standard under the Other Payer Advanced APM
criteria, the total amount that an APM Entity potentially owes the
payer or foregoes under a payment arrangement must be equal to at
least: For the 2019 and 2020 QP Performance Periods, 8 percent of the
total combined revenues from the payer to providers and other entities
under the payment arrangement; or, 3 percent of the expected
expenditures for which an APM Entity is responsible under the payment
arrangement.
We solicited comment on this proposal.
We did not receive any comments in response to this proposal.
We are finalizing our proposal to remove the ``; or'' and replace
it with a ``.'' at Sec. 414.1420(d)(3)(i) because the paragraph that
follows that section does not specify a standard that is necessarily an
alternative to the standard under Sec. 414.1420(d)(3)(i), but rather
expresses a standard that is independent of the standard under Sec.
414.1420(d)(3)(i).
We also proposed to revise Sec. 414.1440(d)(3) to correct a
typographical error by replacing the ``are'' with ``is'' in the third
clause of the second sentence (83 FR 36006).
We solicited comment on this proposal.
We did not receive any comments in response to this proposal.
We are finalizing our proposal to revise Sec. 414.1440(d)(3) to
correct a typographical error by replacing the ``are'' with ``is'' in
the third clause of the second sentence.
c. Summary of Final Policies
We are finalizing these technical corrections to our regulations at
Sec. Sec. 414.1415(b)(1), 414.1420(d)(3)(ii),

[[Page 59940]]

414.1415(c), 414.1420(d), 414.1415(c)(6), 414.1420(d)(7),
414.1420(d)(3)(i), and 414.1440(d)(3) as proposed.

IV. Requests for Information

This section addressed two requests for information (RFI).

A. Request for Information on Promoting Interoperability and Electronic
Healthcare Information Exchange Through Possible Revisions to the CMS
Patient Health and Safety Requirements for Hospitals and Other
Medicare- and Medicaid-Participating Providers and Suppliers

In the CY 2019 PFS proposed rule (83 FR 35704 through 36368), we
included an RFI related to promoting interoperability and electronic
health care information exchange (83 FR 36006 through 36009). We
received approximately 79 timely pieces of correspondence on this RFI.
We appreciate the input provided by commenters.

B. Request for Information on Price Transparency: Improving Beneficiary
Access to Provider and Supplier Charge Information

In the CY 2019 PFS proposed rule (83 FR 35704 through 36368), we
included an RFI related to price transparency and improving beneficiary
access to provider and supplier charge information (83 FR 36009 through
36010). We received approximately 94 timely pieces of correspondence on
this RFI. We appreciate the input provided by commenters.

V. Medicare Shared Savings Program; Accountable Care Organizations--
Pathways to Success

A. Statutory and Regulatory Background

On March 23, 2010, the Patient Protection and Affordable Care Act
(Pub. L. 111-148) was enacted, followed by enactment of the Health Care
and Education Reconciliation Act of 2010 (Pub. L. 111-152) on March 30,
2010, which amended certain provisions of the Patient Protection and
Affordable Care Act (hereinafter collectively referred to as ``the
Affordable Care Act''). Section 3022 of the Affordable Care Act amended
Title XVIII of the Act (42 U.S.C. 1395 et seq.) by adding section 1899
to the Act to establish the Shared Savings Program to facilitate
coordination and cooperation among health care providers to improve the
quality of care for Medicare FFS beneficiaries and reduce the rate of
growth in expenditures under Medicare Parts A and B. See 42 U.S.C.
1395jjj.
The final rule establishing the Shared Savings Program appeared in
the November 2, 2011 Federal Register (Medicare Program; Medicare
Shared Savings Program: Accountable Care Organizations; Final Rule (76
FR 67802) (hereinafter referred to as the ``November 2011 final
rule'')). We viewed this final rule as a starting point for the
program, and because of the scope and scale of the program and our
limited experience with shared savings initiatives under FFS Medicare,
we built a great deal of flexibility into the program rules.
Through subsequent rulemaking, we have revisited and amended Shared
Savings Program policies in light of the additional experience we
gained during the initial years of program implementation as well as
from testing through the Pioneer ACO Model, the Next Generation ACO
Model and other initiatives conducted by the Center for Medicare and
Medicaid Innovation (Innovation Center) under section 1115A of the Act.
A major update to the program rules appeared in the June 9, 2015
Federal Register (Medicare Program; Medicare Shared Savings Program:
Accountable Care Organizations; Final Rule (80 FR 32692) (hereinafter
referred to as the ``June 2015 final rule'')). A final rule addressing
changes related to the program's financial benchmark methodology
appeared in the June 10, 2016 Federal Register (Medicare Program;
Medicare Shared Savings Program; Accountable Care Organizations--
Revised Benchmark Rebasing Methodology, Facilitating Transition to
Performance-Based Risk, and Administrative Finality of Financial
Calculations (81 FR 37950) (hereinafter referred to as the ``June 2016
final rule'')). We have also made use of the annual calendar year (CY)
Physician Fee Schedule (PFS) rules to address updates to the Shared
Savings Program quality measures, scoring, and quality performance
standard, the program's beneficiary assignment methodology and certain
other issues.\34\
---------------------------------------------------------------------------

\34\ See for example: Medicare Program; Revisions to Payment
Policies under the Physician Fee Schedule, Clinical Laboratory Fee
Schedule & Other Revisions to Part B for CY 2014; Final Rule (78 FR
74230, Dec. 10, 2013). Medicare Program; Revisions to Payment
Policies under the Physician Fee Schedule, Clinical Laboratory Fee
Schedule & Other Revisions to Part B for CY 2015; Final Rule (79 FR
67548, Nov. 13, 2014). Medicare Program; Revisions to Payment
Policies under the Physician Fee Schedule, Clinical Laboratory Fee
Schedule & Other Revisions to Part B for CY 2016; Final Rule (80 FR
70886, Nov. 16, 2015). Medicare Program; Revisions to Payment
Policies under the Physician Fee Schedule, Clinical Laboratory Fee
Schedule & Other Revisions to Part B for CY 2017; Final Rule (81 FR
80170, Nov. 15, 2016). Medicare Program; Revisions to Payment
Policies under the Physician Fee Schedule, Clinical Laboratory Fee
Schedule & Other Revisions to Part B for CY 2018; Final Rule (82 FR
52976, Nov. 15, 2017).
---------------------------------------------------------------------------

Policies applicable to Shared Savings Program ACOs have continued
to evolve based on changes in the law. The Medicare Access and CHIP
Reauthorization Act of 2015 (Pub. L. 114-10) (MACRA) established the
Quality Payment Program. In the CY 2017 Quality Payment Program final
rule with comment period (81 FR 77008), CMS established regulations for
the Merit-Based Incentive Payment System (MIPS) and Advanced
Alternative Payment Models (APMs) and related policies applicable to
eligible clinicians who participate in the Shared Savings Program.
The requirements for assignment of Medicare FFS beneficiaries to
ACOs participating under the program were amended by the 21st Century
Cures Act (Pub. L. 114-255). Accordingly, we revised the program's
regulations in the CY 2018 PFS final rule to reflect these new
requirements.
On February 9, 2018, the Bipartisan Budget Act of 2018 was enacted
(Pub. L. 115-123), amending section 1899 of the Act to provide for the
following: Expanded use of telehealth services by physicians or
practitioners participating in an applicable ACO to a prospectively
assigned beneficiary, greater flexibility in the assignment of Medicare
FFS beneficiaries to ACOs by allowing ACOs in tracks under
retrospective beneficiary assignment a choice of prospective assignment
for the agreement period, permitting Medicare FFS beneficiaries to
voluntarily identify an ACO professional as their primary care provider
and mandating that any such voluntary identification will supersede
claims-based assignment, and allowing ACOs under certain two-sided
models to establish CMS-approved beneficiary incentive programs.
On August 17, 2018 a proposed rule, titled ``Medicare Program;
Medicare Shared Savings Program; Accountable Care Organizations--
Pathways to Success'' (hereinafter referred to as the ``August 2018
proposed rule''), appeared in the Federal Register (83 FR 41786). This
proposed rule would provide a new direction for the Shared Savings
Program by establishing pathways to success through redesigning the
participation options available under the program to encourage ACOs to
transition to two-sided models (in which they may share in savings and
are also accountable for repaying any shared losses). As part of the
proposed redesign of the program, we proposed to

[[Page 59941]]

establish two tracks under the program--the BASIC track and the
ENHANCED track. These new participation options were designed to
increase savings for the Trust Funds and mitigate losses, reduce gaming
opportunities, and promote regulatory flexibility and free-market
principles. The August 2018 proposed rule would also provide new tools
to support coordination of care across settings and strengthen
beneficiary engagement; ensure rigorous benchmarking; and promote the
use of interoperable electronic health record technology among ACO
providers/suppliers. We received 470 timely pieces of correspondence in
response to the August 2018 proposed rule. In the following sections of
this final rule, we address a subset of the proposals described in the
August 2018 proposed rule. We summarize and respond to the significant
public comments on these proposals and discuss our final policies with
respect to these issues after taking into consideration the public
comments we received on this subset of proposals. We are not addressing
the other topics included in the August 2018 proposed rule at this
time. We will summarize and respond to public comments on these other
proposed policies in a forthcoming final rule. We also received
comments that are outside the scope of the August 2018 proposed rule.
We may consider these comments when evaluating current Shared Savings
Program policies and contemplating future refinements to the program.

B. Finalization of Certain Provisions of the Shared Savings Program
August 2018 Proposed Rule

In this section of the final rule, we discuss the proposal, the
comments received, and the final action that we are taking for the
following proposals in the August 2018 proposed rule:
A voluntary 6-month extension for existing ACOs whose
participation agreements expire on December 31, 2018, and the
methodology for determining financial and quality performance for this
6-month performance year from January 1, 2019 through June 30, 2019. We
believe it is necessary to finalize the extension before these ACOs'
participation agreements expire on December 31, 2018, so that they can
continue their participation in the program without interruption. It is
also necessary to finalize the methodology for determining ACO quality
and financial performance for the extension period in advance of the 6-
month performance year beginning on January 1, 2019.
Implementation of the provisions of section 50331 of the
Bipartisan Budget Act of 2018 on voluntary alignment. The Bipartisan
Budget Act was enacted earlier this year, and we believe it is most
consistent with the requirements of the statute to revise our voluntary
alignment policies effective with assignment for performance years
starting on January 1, 2019, to reflect the additional flexibility
given to beneficiaries in selecting their primary care provider.
A modification to the definition of primary care services
used in assigning beneficiaries to ACOs to reflect recent code changes.
Including these codes in the definition of primary care services will
improve the accuracy of the assignment methodology and help to ensure
that beneficiaries are assigned to the ACO that is responsible for
coordinating their overall care.
Relief for ACOs and their clinicians impacted by extreme
and uncontrollable circumstances in performance year 2018 and
subsequent years. We believe it is necessary to finalize the changes to
the extreme and uncontrollable circumstances policies for the Shared
Savings Program as quickly as possible to ensure that relief is
available for ACOs affected by the recent hurricanes in North Carolina
and Florida and other disasters during 2018.
Revisions to program requirements to further promote
interoperability among ACO providers and suppliers. We believe it is
necessary to finalize changes to our CEHRT use requirements to align
with the Quality Payment Program.
We are also making technical changes to update the authority
citation for 42 CFR part 425 to conform with OFR requirements.
The changes will be effective on December 31, 2018. Applicability
or implementation dates may vary, depending on the policy, and the
timing specified in this final rule. By indicating that a provision is
applicable to a performance year (PY) or agreement period, activities
related to implementation of the policy may precede the start of the
performance year or agreement period.
1. Participation Options for Agreement Periods Beginning in 2019
In this final rule, we are addressing a subset of the proposals in
the August 2018 proposed rule for participation options for agreement
periods beginning in 2019. In the August 2018 proposed rule, we stated
that we would forgo an application cycle for a January 1, 2019
agreement start date and proposed to allow for a July 1, 2019 agreement
start date. We proposed an approach for determining financial and
quality performance for two 6-month performance years during 2019, with
the first from January 1, 2019 through June 30, 2019, for ACOs with
participation agreements expiring on December 31, 2018, that elect a
voluntary 6-month extension, and the second from July 1, 2019 through
December 31, 2019, for ACOs entering a new agreement period beginning
July 1, 2019. We also proposed an approach for determining financial
and quality performance for the performance period from January 1, 2019
through June 30, 2019 for an ACO starting a 12-month performance year
on January 1, 2019, that terminates its participation agreement with an
effective date of termination of June 30, 2019, and enters a new
agreement period beginning on July 1, 2019, referred to as ``early
renewals.''
In this final rule, we are addressing our proposals to allow for a
voluntary 6-month extension for ACOs whose agreement periods expire on
December 31, 2018, and to establish a methodology for determining
financial and quality performance for the 6-month performance year from
January 1, 2019 through June 30, 2019. These proposals were necessary
to prevent some ACOs from experiencing an involuntary gap in
participation as a result of our decision to forgo an application cycle
in 2018 for a January 1, 2019 agreement start date. Therefore, in this
section of the final rule, we summarize and respond to comments and
address final actions specific to our proposals regarding the 6-month
extension and the methodology for determining financial and quality
performance for the 6-month performance year from January 1, 2019
through June 30, 2019. As we describe in this section, some
modifications to our proposals are necessary because of the limited
scope of this final rule.
In a forthcoming final rule, we anticipate summarizing and
responding to public comments on the other proposed policies related to
determining financial and quality performance in 2019 for the
following: (1) The performance period from January 1, 2019 through June
30, 2019, for ACOs starting a 12-month performance year on January 1,
2019, that terminate their participation agreement with an effective
date of termination of June 30, 2019, and enter a new agreement period
beginning on July 1, 2019; and (2) the 6-month performance year from
July 1, 2019 through December 31, 2019, for ACOs entering an agreement
period beginning on July 1, 2019.

[[Page 59942]]

a. Voluntary Extension for a 6-Month Performance Year From January 1,
2019 Through June 30, 2019, for ACOs Whose Current Agreement Period
Expires on December 31, 2018
In section II.A.7. of the August 2018 proposed rule (83 FR 41847),
we explained that we were forgoing the application cycle that otherwise
would take place during CY 2018 for a January 1, 2019 start date for
new Shared Savings Program participation agreements, initial use of the
Skilled Nursing Facility (SNF) 3-day rule waiver, and entry into the
Track 1+ Model, and we proposed to offer a July 1, 2019 start date as
the initial opportunity for ACOs to enter an agreement period under the
proposed BASIC track or ENHANCED track, which would be offered under
the proposed redesign of the program's participation options. We
proposed the July 1, 2019 start date as a one-time opportunity, and
thereafter we would resume our typical process of offering an annual
application cycle that allows for review and approval of applications
in advance of a January 1 agreement start date.
We proposed that ACOs that entered a first or second agreement
period with a start date of January 1, 2016 could elect to extend their
agreement period for an optional fourth performance year, defined as
the 6-month period from January 1, 2019 through June 30, 2019. This
election to extend the agreement period would be voluntary and an ACO
could choose not to extend its agreement period, in which case it would
conclude its participation in the program with the expiration of its
current agreement period on December 31, 2018.
We proposed that the ACO's voluntary election to extend its
agreement period must be made in the form and manner and according to
the timeframe established by CMS, and that an ACO executive who has the
authority to legally bind the ACO must certify the election. We
explained our expectation that this election process, if finalized,
would begin in 2018 following the publication of the final rule, as
part of the annual certification process in advance of 2019 (described
in section II.A.7.c.(2) of the August 2018 proposed rule (83 FR
41855)). We noted that this optional 6-month agreement period extension
would be a one-time exception for ACOs with agreements expiring on
December 31, 2018, and would not be available to other ACOs that are
currently participating in a 3-year agreement in the program, or to
future program entrants.
In the August 2018 proposed rule, we noted that under the existing
provision at Sec. 425.210, the ACO must provide a copy of its
participation agreement with CMS to all ACO participants, ACO
providers/suppliers, and other individuals and entities involved in ACO
governance. Further, all contracts or arrangements between or among the
ACO, ACO participants, ACO providers/suppliers, and other individuals
or entities performing functions or services related to ACO activities
must require compliance with the requirements and conditions of the
program's regulations, including, but not limited to, those specified
in the participation agreement with CMS. We proposed that an ACO that
elects to extend its participation agreement by 6 months must notify
its ACO participants, ACO providers/suppliers and other individuals or
entities performing functions or services related to ACO activities of
this continuation of participation and must require their continued
compliance with the program's requirements for the 6-month performance
year from January 1, 2019 through June 30, 2019.
As discussed in section II.A.2. of the August 2018 proposed rule
(83 FR 41799 through 41800), we proposed modifications to the
definition of ``agreement period'' in Sec. 425.20 to broaden the
definition to generally refer to the term of the participation
agreement. We also proposed to add a provision at Sec. 425.200(b)(2)
specifying that the term of the participation agreement is 3 years and
6 months for an ACO that entered an agreement period starting on
January 1, 2016, that elects to extend its agreement period until June
30, 2019, and this election is made in the form and manner and
according to the timeframe established by CMS, and certified by an ACO
executive who has the authority to legally bind the ACO (83 FR 41849).
For consistency, we also proposed minor formatting changes to the
existing provision at Sec. 425.200(b)(2) and (b)(3) to italicize the
header text.
We also proposed to revise the definition of ``performance year''
in Sec. 425.20 to mean the 12-month period beginning on January 1 of
each year during the agreement period, unless otherwise specified in
Sec. 425.200(c) or noted in the participation agreement. We also
proposed revisions to Sec. 425.200(c) to make necessary formatting
changes and specify additional exceptions to the definition of
performance year as a 12-month period. Specifically, we proposed to add
a provision specifying that for an ACO that entered a first or second
agreement period with a start date of January 1, 2016, and that elects
to extend its agreement period by a 6-month period, the ACO's fourth
performance year is the 6-month period between January 1, 2019, and
June 30, 2019. Similarly, we proposed to add a provision specifying
that for an ACO that entered an agreement period with a start date of
July 1, 2019, the ACO's first performance year of the agreement period
is defined as the 6-month period between July 1, 2019, and December 31,
2019 (83 FR 41849).
In light of the proposed modifications to Sec. 425.200(c) to
establish two 6-month performance years during CY 2019, we proposed
revisions to the regulation at Sec. 425.200(d), which reiterates an
ACO's obligation to submit quality measures in the form and manner
required by CMS for each performance year of the agreement period, to
address the quality reporting requirements for ACOs participating in a
6-month performance year during CY 2019 (83 FR 41849).
We also considered forgoing an application cycle for a 2019 start
date altogether and allowing ACOs to enter agreement periods under the
proposed BASIC track and ENHANCED track for the first time beginning on
January 1, 2020. This approach would allow ACOs additional time to
consider the redesign of the program, make organizational and
operational plans, and implement business and investment decisions, and
would avoid the complexity of needing to determine performance based on
6-month performance years during CY 2019. However, we noted that our
proposed approach of offering an application cycle during 2019 for an
agreement period start date of July 1, 2019 would allow for a more
rapid progression of ACOs to the redesigned participation options,
starting in mid-2019. We further noted that, under this alternative, we
would also want to offer ACOs that started a first or second agreement
period on January 1, 2016, a means to continue their participation
between the conclusion of their current 3-year agreement period
(December 31, 2018) and the start of their next agreement period
(January 1, 2020), should the ACO wish to continue in the program. We
indicated that under that alternative, which would postpone the start
date for the new participation options to January 1, 2020, we would
allow ACOs that started a first or second agreement period on January
1, 2016, to elect a 12-month extension of their current agreement
period to cover the duration of CY 2019.
We sought comment on these proposals and the related
considerations, as well as the alternatives considered.

[[Page 59943]]

Comment: Regarding the program's application cycles, most
commenters generally supported CMS' decision to forgo an application
cycle during CY 2018 for a January 1, 2019 agreement start date.
Several commenters explained their support for this decision was due to
the significant revisions to program policies contained in the proposed
rule.
Response: We thank commenters for their support of our decision to
forgo the application cycle that otherwise would take place during CY
2018 for a January 1, 2019 start date for new Shared Savings Program
participation agreements.
Comment: Of the comments addressing the length of the extension for
ACOs with agreement periods expiring December 31, 2018, a few
commenters generally supported the proposed participation options for
agreement periods beginning in 2019, including the proposed 6-month
extension. Several commenters stated their support for CMS' proposal to
allow ACOs with agreement periods ending December 31, 2018, to extend
their agreements through June 30, 2019. Several commenters suggested
that CMS allow ACOs whose agreement periods expire on December 31,
2018, an option to extend their current participation agreement by
either 6 months or 12 months. In addition, many commenters supported
allowing these ACOs the opportunity to elect a voluntary 12-month
extension of their current agreement period, for a fourth performance
year from January 1, 2019 through December 31, 2019. One commenter,
whose comment was primarily focused on the applicability of policies to
Track 1 ACOs, specifically recommended that this 12-month extension
option should be offered for Track 1 ACOs. One commenter suggested that
CMS permit Track 3 ACOs a 12-month extension for the performance year
from January 1, 2019 through December 31, 2019, and that CMS apply
certain aspects of the proposed program redesign, including the use of
factors based on regional FFS expenditures in establishing, updating
and adjusting the ACO's historical benchmark and the availability of
beneficiary incentive programs, during this optional fourth 12-month
performance year, enabling these Track 3 ACOs to gain experience with
these policies before deciding whether to continue their participation
in the Shared Savings Program in the ENHANCED track.
Some commenters explained that providing a 12-month extension
option would give ACOs additional time to analyze program changes and
prepare for the application process. One commenter expressed concern
that a 6-month extension would provide a limited and inadequate amount
of time for ACOs to consider participation options under a redesigned
program, if a final rule establishing a July 1, 2019 start date is not
issued until later in 2018. This commenter expressed the belief that
this limited time to consider participation options in advance of a
July 1, 2019 start date (if finalized) and general uncertainty about
program policies would result in program attrition, due to ACOs and ACO
participants electing not to continue in the program at the end of
their current agreement. One commenter explained a 12-month extension
would give ACOs additional time to evaluate whether they have the
appropriate structure in place, implement processes to comply with new
regulations, and make necessary changes to their ACO participant and
ACO provider/supplier networks.
One commenter explained a 12-month extension would provide current
ACOs with additional time and experience under their current agreement
periods. Some commenters explained that providing a 12-month extension
could avoid the complexity and increased burden on providers,
practices, ACOs, and CMS that could potentially result from ACOs'
participation in two, 6-month performance years in CY 2019. Other
commenters raised concerns about making ACO participant list changes,
and modifying agreements with their ACO participants, to allow for
participation in two, 6-month performance years during CY 2019, with
each performance year under a separate participation agreement: The
first 6-month performance year under their current participation
agreement (in an extension of their current agreement period); and the
second 6-month performance year under a new participation agreement
under one of the proposed redesigned participation options. Some
commenters requesting a 12-month extension, or the choice between a 6-
month or a 12-month extension, also raised concerns about the
methodology for determining financial and quality performance for two,
6-month performance years during CY 2019. We summarize and respond to
comments related to the methodology for determining performance for the
6-month performance year from January 1, 2019 through December 31,
2019, and other program policies applicable to ACOs participating in
this 6-month performance year, in sections V.B.1.b. and V.B.1.c. of
this final rule.
Response: We are not addressing in this final rule, comments on the
timing for implementing the proposed redesign of the Shared Savings
Program's participation options. However, we believe it is important to
allow for continuity in participation for ACOs whose participation
agreements expire December 31, 2018.
We appreciate commenters' concerns about preparing to enter a new
agreement period in light of uncertainty around the participation
options that may be available. However, we note that, based on the
proposals in the August 2018 proposed rule, ACOs whose agreement
periods expire on December 31, 2018, that were interested in continuing
their participation in the program have had an opportunity to identify
their likely ACO participants for the proposed 6-month performance year
from January 1, 2019 through June 30, 2019, and have received
preliminary feedback from CMS for ACO participant list additions for
the performance year beginning on January 1, 2019. Moreover, we believe
these ACOs generally have begun preparing the necessary revisions to
their agreements with ACO participants and ACO providers/suppliers and,
if under a two-sided model to extend their repayment mechanism in
anticipation of the possibility that we would finalize the proposed 6-
month extension period. We believe these ACOs have also been weighing
their participation options in advance of applying to renew for a
subsequent agreement period, and will have additional time to make
these determinations during the 6-month extension (if elected). In
particular, ACOs reaching the conclusion of their second agreement
period under Track 1, would have been weighing their participation
options under two-sided models, given the current requirement that ACOs
transition to a two-sided model by the start of their third agreement
period. In fact, the 6-month extension allows ACOs completing their
second agreement period in Track 1 to continue participation under
their current agreement period and thereby receive additional time
under a one-sided model that otherwise would not have been available to
these ACOs under the program's current regulations.
We also believe it is important to ensure we retain the flexibility
to allow ACOs to more rapidly transition, starting as early as July 1,
2019, to the proposed new participation options, should they be
finalized, including the participation options that would be Advanced
APMs that would allow eligible clinicians participating in the ACO to
qualify for incentive payments

[[Page 59944]]

under the Quality Payment Program. We believe that rapid transition to
the new participation options would drive more meaningful systematic
change in ACOs, which have the potential to control their assigned
beneficiaries' Medicare Parts A and B FFS expenditures by coordinating
care across care settings, and thus to achieve significant change in
spending.
At this time, we believe the proposed 6-month extension for a 6-
month performance year from January 1, 2019 through June 30, 2019,
strikes an appropriate balance between these factors. To reduce the
possibility for selective participation bias that could adversely
affect the Trust Funds, we believe the same option for extending their
current participation agreement should be made available to all
eligible ACOs whose agreement periods expire December 31, 2018, as
opposed to offering ACOs the option to choose between either a 6-month
or a 12-month extension, or offering extensions of different lengths to
ACOs based on their current participation track. For example, we
believe that if we offered a choice regarding the length of the
extension, only ACOs that would expect to benefit from being rebased
under new program policies would elect a 6-month extension in order to
allow the regional rebasing policies to apply sooner.
We also decline to adopt the commenter's suggestions that we
finalize certain aspects of the proposed program redesign, such as the
proposed modifications to the methodology for establishing, adjusting
and updating an ACO's historical benchmark, and certain payment and
program flexibilities for eligible ACOs participating under two-sided
models, and apply these policies to a subset of the ACOs electing the
voluntary extension. Continuing to apply the current benchmarking
methodology during the optional fourth performance year maintains ACOs'
existing historical benchmarks, allowing them to continue to build on
their experience within their current agreement period and provides a
more predictable and stable benchmark during the 6-month extension
period. We also decline to allow only ACOs that are eligible for and
elect the extension to have access to and make use of additional
program and payment flexibilities (such as a SNF 3-day rule waiver,
unless previously approved, or a beneficiary incentive program) as a
way of allowing these organizations to gain experience with these
policies in advance of their broader availability (if finalized) to
eligible ACOs participating in the program. Our proposals to extend the
availability of a SNF 3-day rule waiver and to give ACOs the
opportunity to offer beneficiary incentive programs were developed in
conjunction with our proposed changes to the participation options for
ACOs participating in the Shared Savings Program. Therefore, we believe
these proposals need to be considered together as part of a forthcoming
final rule addressing our proposals for the overall redesign of the
Shared Savings Program. Further, we believe it would be cumbersome to
determine ACOs' eligibility for these flexibilities prior to the start
of the performance year beginning January 1, 2019, particularly given
the absence of a formal application cycle during CY 2018 during which
ACOs could elect to apply for such opportunities.
Comment: One commenter pointed to the Regulatory Impact Analysis of
the August 2018 proposed rule (83 FR 41926), and our estimate that a
12-month extension for ACOs whose participation agreements expire on
December 31, 2018, would reduce overall Federal spending by
approximately an additional $100 million, as further justification for
allowing a 12-month rather than a 6-month extension.
Response: We believe it is important to allow for continuity in
participation for ACOs whose agreement periods expire on December 31,
2018. We also believe it is important to ensure ACOs more rapidly
transition to new participation options in the event we finalize a mid-
year start date for those participation options in 2019. At this time,
we believe the proposed 6-month extension for a 6-month performance
year from January 1, 2019 through June 30, 2019, strikes an appropriate
balance between these factors. The estimated impact of a 12-month
extension for ACOs whose current agreement periods expire on December
31, 2018, is not comparable to the impact estimated for a 6-month
extension for this same group of ACOs. To explain further, the impact
estimate for a 12-month extension was estimated under a different
hypothetical baseline. Differences in participation resulting from a 6-
month or a 12-month extension were not a major factor in the impact
estimate because under the proposed approach, a 12-month extension
would not have changed the ultimate date that renewing ACOs would be
required to transition to performance-based risk under the proposed
redesign. For example, for Track 1 ACOs, a 12-month extension for
performance year 2019 under Track 1 would result in the Track 1 ACO
being eligible to participate in proposed BASIC track Level B during
performance year 2020, whereas with a 6-month extension for a
performance year from January 1, 2019 through June 30, 2019, under
Track 1, would permit the ACO up to 1.5 years under proposed BASIC
track Level B, because the ACO would not automatically transition from
Level B to Level C at the start of performance year 2020 under the
policies included in the proposed rule. In either event, however, the
ACO would be required to participate in performance-based risk under
Level C, D, or E of the BASIC track by performance year 2021. There
were also a number of other competing factors working in different
directions, such as the benchmark the ACO participates under, and the
availability of Advanced APM incentive payments, which ultimately led
to our projection that the 12-month extension would result in somewhat
greater savings over 10 years when compared to the modeling of the
proposed 6-month extension.
Comment: One commenter expressed confusion over whether the
voluntary election for a 6-month performance year from January 1, 2019
through June 30, 2019, was an option for ACOs within an agreement
period (such as an ACO that entered an agreement period on January 1,
2018) as part of the proposed early renewal process.
Response: The optional 6-month extension is only available for ACOs
with agreements expiring on December 31, 2018, and would not be
available to other ACOs that are currently participating in a 3-year
agreement period in the program because their agreements are not
expiring. Thus, these ACOs do not require the option of a 6-month
extension because their current agreement periods will continue during
2019 and they will not experience a gap in participation as a result of
our decision to forgo the application cycle in 2018 for an agreement
start date of January 1, 2019.
Comment: One commenter suggested that all Track 3 ACOs should be
offered an extension of their current agreement period, regardless of
the ACO's agreement period start date.
Response: We proposed that the one-time, 6-month extension would
only be available to ACOs whose agreement periods expire on December
31, 2018, in order to ensure that these ACOs would be able to continue
participation in the Shared Savings Program without any gap. At this
time, we decline the commenter's alternative suggestion that we offer a
similar 6-month extension to ACOs whose agreement periods expire in
subsequent years. These ACOs would not need a 6-month extension because
we anticipate a typical, annual application cycle would be available in

[[Page 59945]]

future years so that these ACOs could renew their participation
agreements and continue their participation in the program without
interruption.
Comment: Some commenters urged CMS to provide additional guidance
and education to ACOs on how ACOs should modify their agreements with
their ACO participants for the 2019 performance periods. Several ACOs,
with agreement periods expiring on December 31, 2018, submitted
comments describing the burden of executing updated participation
agreements with their ACO participants to account for the 6-month
extension and the start of a new agreement period under one of the new
participation options. These commenters explained that expecting the
program would offer an application cycle in CY 2018 for a January 1,
2019 agreement start date, their newly executed ACO participant
agreements were structured according to the program's current policies
(under the program's regulations and, as applicable, the terms of the
Track 1+ Model) and do not account for the 6-month extension or
modified participation options under the proposed redesign of the
program. One commenter expressed concern that the extension would cause
some ACO participants to be operating under a different ACO
participation agreement, depending on whether they started
participating in the ACO prior to January 1, 2019, or after January 1,
2019, resulting in different sets of expectations, for example with
respect to the distribution of shared savings. According to one
commenter, the time and cost spent on revising agreements with their
ACO participants would significantly burden the ACO and its
participants, and delay the execution of many initiatives to reduce
costs and improve the quality of care as the ACO would spend time
executing revised agreements with its ACO participants rather than
focusing on other aspects of its operations. One commenter requested
that ACOs whose agreement periods expire on December 31, 2018, be given
ample time to secure extensions to their agreements with ACO
participants for 2019.
Response: To prepare for the extension period, ACOs electing to
extend their participation agreement with CMS must update their ACO
participant agreements and SNF affiliate agreements, as applicable,
before the beginning of the next performance year to reflect the
extension of their current agreement period. As part of the annual
certification process in advance of 2019, ACOs electing the 6-month
extension will be required to certify that they have notified their ACO
participants and SNF affiliates, if applicable, of their continued
participation in the Shared Savings Program in 2019, and that their ACO
participant agreements and SNF affiliate agreements, if applicable,
have been updated. However, ACOs will not be required to submit ACO
participant agreement or SNF affiliate agreement extensions to CMS.
ACOs electing the extension would need to extend all current ACO
participant and/or SNF affiliate agreements on or before December 31,
2018, so that entities will continue to be ACO participants or SNF
affiliates, as applicable, for the performance year beginning on
January 1, 2019. Additionally, the ACO will need to execute ACO
participant agreements with any new ACO participants to be added to its
ACO participant list effective January 1, 2019. We also note that these
ACOs would have been required to revise their ACO participant and SNF
affiliate agreements, as applicable, if they had been renewing their
participation agreements for a new agreement period beginning January
1, 2019. We also note that we now allow ACOs, ACO participants and SNF
affiliates to digitally sign their agreements, which should help to
reduce any burden associated with extending agreements. We believe that
the timing of the issuance of this final rule will permit sufficient
time for ACOs electing to extend their participation agreements to take
the necessary steps to extend their ACO participant and SNF affiliate
agreements, as applicable, before the start of the 6-month performance
year beginning January 1, 2019.
In response to the commenter's concern that the extension would
cause some ACO participants to be operating under different sets of
expectations (depending on whether they started participating in the
ACO prior to January 1, 2019 or after January 1, 2019), we note that
for ACOs that elect the 6-month extension, the payment methodology
under the ACO's current track would be applicable to determining the
ACO's shared savings or shared losses, if applicable, for the 6-month
performance year from January 1, 2019 through June 30, 2019. This is
the same payment methodology that has applied to the ACO for the
duration of its agreement period, beginning on January 1, 2016.
Further, we note that with the exception of the requirements
specified at Sec. 425.116, the ACO and its ACO participants have
significant flexibility to determine the contractual terms that would
apply with respect to all ACO participant agreements, including with
respect to the use/distribution of shared savings (and payment of
shared losses).
Comment: One commenter explained that current and prospective ACOs
and their leaders are evaluating their options with respect to not only
the Shared Savings Program start date, but also to participation in
other potential models such as the Direct Provider Contracting (DPC)
models anticipated to be tested by CMS' Innovation Center. The
commenter urged CMS to take the whole payment model landscape into
account and to take any measures necessary to maximize the level of
certainty for healthcare providers and to incentivize participation in
higher-risk models over lower-risk models. For example, the commenter
recommended that participants in the Shared Savings Program or current
Innovation Center models should not be excluded from switching to a DPC
model if and when such a model becomes available, regardless of where
they are in their current agreement period or the lifecycle of their
current model.
Response: We work to align and otherwise create synergies between
the Shared Savings Program and the payment and service delivery models
tested by the Innovation Center. We have policies in place to take into
account overlap between the Shared Savings Program and Innovation
Center models, which are designed to test new payment and service
delivery models for the purpose of innovating in the areas of
healthcare delivery and shared accountability for quality and financial
performance, whenever possible. We continue to monitor these policies
and make refinements as we gain experience and lessons learned from
these interactions. When new models are announced, we encourage ACOs
and their leaders to engage in dialogue with the Innovation Center and
Shared Savings Program staff to inform their decision-making regarding
the participation options.
After considering the comments received, we are finalizing our
proposal to allow ACOs that entered a first or second agreement period
beginning on January 1, 2016, to voluntarily elect a 6-month extension
of their current agreement period for a fourth performance year from
January 1, 2019 through June 30, 2019. For the reasons discussed, we
believe this extension is necessary in order to avoid an involuntary
gap in participation and to provide ACOs with an opportunity to prepare
for a more rapid transition to the proposed new participation options,
including new Advanced APMs that would allow eligible clinicians

[[Page 59946]]

participating in these ACOs to qualify for incentive payments under the
Quality Payment Program.
We received no comments on the proposed modifications to the
definitions of ``agreement period'' and ``performance year'' in Sec.
425.20 or to the regulation at Sec. 425.200 to establish the 6-month
extension and to make certain technical and conforming changes. We are
finalizing as proposed the modifications to the definition of
``agreement period'' in Sec. 425.20 to broaden the definition to
generally refer to the term of the participation agreement and the
revisions to Sec. 425.200(a) to allow for agreement periods greater
than 3 years. We are also finalizing our proposal to add a provision at
Sec. 425.200(b)(2) specifying that the term of the participation
agreement is 3 years and 6 months for an ACO that entered an agreement
period starting on January 1, 2016, that elects to extend its agreement
period until June 30, 2019, and this election is made in the form and
manner and according to the timeframe established by CMS, and certified
by an ACO executive who has the authority to legally bind the ACO. For
consistency, we are also finalizing as proposed the minor formatting
changes to the existing provisions at Sec. 425.200(b)(2) and (b)(3) to
italicize the header text.
We are also finalizing as proposed the revision to the definition
of ``performance year'' in Sec. 425.20 to mean the 12-month period
beginning on January 1 of each year during the agreement period, unless
otherwise specified in Sec. 425.200(c) or noted in the participation
agreement. Therefore, we are also finalizing the proposed revisions to
Sec. 425.200(c) to make necessary formatting changes and specify an
additional exception to the definition of performance year as a 12-
month period. Specifically, we are finalizing our proposal to add a
provision specifying that for an ACO that entered a first or second
agreement period with a start date of January 1, 2016, and that elects
to extend its agreement period by a 6-month period, the ACO's fourth
performance year is the 6-month period between January 1, 2019, and
June 30, 2019.
In light of the modifications we are finalizing to Sec. 425.200(c)
to establish a 6-month performance year during CY 2019, we are also
finalizing the proposed revisions to the regulation at Sec.
425.200(d), which reiterates an ACO's obligation to submit quality
measures in the form and manner required by CMS for each performance
year of the agreement period, to address the quality reporting
requirements for ACOs participating in the 6-month performance year
from January 1, 2019 through June 30, 2019. As described elsewhere in
this final rule, ACOs electing the voluntary 6-month extension will be
required to report quality measures for the 2019 reporting period,
based on CY 2019, consistent with the existing quality reporting
process and methodology.
b. Methodology for Determining Financial and Quality Performance for
the 6-Month Performance Year From January 1, 2019 Through June 30, 2019
(1) Background and Description of Methodology
Under our proposed approach to determining performance for the 6-
month performance year from January 1, 2019 through June 30, 2019,
after the conclusion of CY 2019, CMS would reconcile the financial and
quality performance of ACOs that participated in the Shared Savings
Program during 2019. For ACOs that extended their agreement period for
the 6-month performance year from January 1, 2019 through June 30,
2019, CMS would first reconcile the ACO based on its performance during
the entire 12-month calendar year, and then pro-rate the calendar year
shared savings or shared losses to reflect the ACO's participation for
only half of the calendar year. In the August 2018 proposed rule, we
explained this approach would avoid a more burdensome interim payment
process that could accompany an alternative proposal to instead
implement, for example, an 18-month performance year. Consistent with
the 18- and 21-month performance years offered for the first cohorts of
Shared Savings Program ACOs, such a policy could require ACOs to
establish a repayment mechanism that otherwise might not be required,
create uncertainty over whether the ACO may ultimately need to repay
CMS based on final results for the extended performance year, and delay
ACOs seeing a return on their investment in program participation if
eligible for shared savings.
We explained our belief that the proposed approach would allow
continuity in program operations, including operations that occur on a
calendar year basis. Specifically, the proposed approach would allow
payment reconciliation to remain on a calendar year basis, which would
be most consistent with the calendar year-based methodology for
calculating benchmark expenditures, trend and update factors, risk
adjustment, county expenditures and regional adjustments. We explained
that deviating from a 12-month reconciliation calculation by using
fewer than 12 months of performance year expenditures could interject
actuarial biases relative to the benchmark expenditures, which are
based on 12-month benchmark years. As a result, we believed the
proposed approach of reconciling ACOs based on a 12-month period would
protect the actuarial soundness of the financial reconciliation
methodology. We also explained our belief that the alignment of the
proposed approach with the standard methodology used to perform the
same calculations for 12-month performance years that correspond to a
calendar year would make it easier for ACOs and other program
stakeholders to understand the proposed methodology.
As is the case with typical calendar year reconciliations in the
Shared Savings Program, we anticipated results with respect to
participation during CY 2019 would be made available to ACOs in summer
2020. We explained that this would allow those ACOs that are eligible
to share in savings as a result of their participation in the program
during CY 2019 to receive payment of shared savings following the
conclusion of the calendar year consistent with the standard process
and timing for annual payment reconciliation under the program.
In section II.A.7.b.2 of the August 2018 proposed rule (83 FR 41851
through 41853), we described in detail our proposed approach to
determining an ACO's performance for the 6-month performance year from
January 1, 2019 through June 30, 2019. We also proposed that these
policies would apply to ACOs that begin a 12-month performance year on
January 1, 2019, but elect to terminate their participation agreement
with an effective date of termination of June 30, 2019, in order to
enter a new agreement period starting on July 1, 2019 (early renewals).
Our proposed policies addressed the following: (1) The ACO participant
list that will be used to determine beneficiary assignment; (2) the
approach to assigning beneficiaries; (3) the quality reporting period;
(4) the benchmark year assignment methodology and the methodology for
calculating, adjusting and updating the ACO's historical benchmark; and
(5) the methodology for determining shared savings and shared losses.
We proposed to specify these policies for reconciling the 6-month
period from January 1, 2019 through June 30, 2019, in paragraph (b) of
a new section of the regulations at Sec. 425.609.
We proposed to use the ACO participant list for the performance
year beginning January 1, 2019, to determine

[[Page 59947]]

beneficiary assignment as specified in Sec. Sec. 425.402 and 425.404,
and according to the ACO's track as specified in Sec. 425.400. As
discussed in section II.A.7.c. of the August 2018 proposed rule (83 FR
41855 through 41856), we proposed to allow all ACOs, including ACOs
entering a 6-month performance year, to make changes to their ACO
participant list in advance of the performance year beginning January
1, 2019. Related considerations are discussed in section V.B.1.c.(2) of
this final rule.
To determine beneficiary assignment, we proposed to consider the
allowed charges for primary care services furnished to the beneficiary
during a 12-month assignment window, allowing for a 3 month claims run
out. For the 6-month performance year from January 1, 2019 through June
30, 2019, we proposed to determine the assigned population using the
following assignment windows:
For ACOs under preliminary prospective assignment with
retrospective reconciliation, the assignment window would be CY 2019.
For ACOs under prospective assignment, Medicare FFS
beneficiaries would be prospectively assigned to the ACO based on the
beneficiary's use of primary care services in the most recent 12 months
for which data are available. For example, in determining prospective
beneficiary assignment for the January 1, 2019 through June 30, 2019
performance year we could use an assignment window from October 1, 2017
through September 30, 2018, to align with the off-set assignment window
typically used to determine prospective assignment prior to the start
of a calendar year performance year. Beneficiaries would remain
prospectively assigned to the ACO at the end of CY 2019 unless they
meet any of the exclusion criteria under Sec. 425.401(b) during the
calendar year.
As discussed in section II.A.7.c.(4) of the August 2018 proposed
rule (83 FR 41856), to determine ACO performance during a 6-month
performance year, we proposed to use the ACO's quality performance for
the 2019 reporting period, and to calculate the ACO's quality
performance score as provided in Sec. 425.502. We also proposed to use
a different quality measure sampling methodology depending on whether
an ACO participates in both a 6-month performance year (or performance
period) beginning on January 1, 2019, and a 6-month performance year
beginning on July 1, 2019, or only participates in a 6-month
performance year from January 1, 2019 through June 30, 2019. As
described in section V.B.1.c.(4) of this final rule, given the limited
scope of this final rule, at this time, we are finalizing only our
proposal to use the ACO's latest certified participant list (the ACO
participant list effective on January 1, 2019) to determine the quality
reporting samples for the 2019 reporting period for ACOs that extend
their prior participation agreement for the 6-month performance year
from January 1, 2019 to June 30, 2019.
Consistent with current program policy, we proposed to determine
assignment for the benchmark years based on the most recent certified
ACO participant list for the ACO effective for the performance year
beginning January 1, 2019. This would be the participant list the ACO
certified prior to the start of its agreement period unless the ACO has
made changes to its ACO participant list during its agreement period as
provided in Sec. 425.118(b). If the ACO has made subsequent changes to
its ACO participant list, we would adjust its historical benchmark to
reflect the most recent certified ACO participant list. See the
Medicare Shared Savings Program, ACO Participant List and Participant
Agreement Guidance (July 2018, version 5), available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/Downloads/ACO-Participant-List-Agreement.pdf.
For the 6-month performance year from January 1, 2019 through June
30, 2019, we proposed to determine the benchmark and calculate
performance year expenditures for assigned beneficiaries as though the
performance year were the entire calendar year. The ACO's historical
benchmark would be determined according to the methodology applicable
to the ACO based on its agreement period in the program. We would apply
the methodology for establishing, updating and adjusting the ACO's
historical benchmark as specified in Sec. 425.602 (for ACOs in a first
agreement period) or Sec. 425.603 (for ACOs in a second agreement
period), except that data from CY 2019 would be used in place of data
for the 6-month performance year in certain calculations, as follows:
The benchmark would be adjusted for changes in severity
and case mix between benchmark year 3 and CY 2019 using the methodology
that accounts separately for newly and continuously assigned
beneficiaries using prospective HCC risk scores and demographic factors
as described under Sec. Sec. 425.604(a)(1) through (3), 425.606(a)(1)
through (3), and 425.610(a)(1) through (3).
The benchmark would be updated to CY 2019 according to the
methodology for using growth in national Medicare FFS expenditures for
assignable beneficiaries described under Sec. Sec. 425.602(b) (for
ACOs in a first agreement period) and 425.603(b) (for ACOs in a second
agreement period beginning January 1, 2016).
For determining financial performance during the 6-month
performance year from January 1, 2019 through June 30, 2019, we would
apply the methodology for determining shared savings and shared losses
according to the approach specified for the ACO's track under the terms
of the participation agreement that was in effect on January 1, 2019:
Sec. 425.604 (Track 1), Sec. 425.606 (Track 2) or Sec. 425.610
(Track 3) and, if applicable, the terms of the ACO's participation
agreement for the Track 1+ Model authorized under section 1115A of the
Act. (See discussion in section II.F. of the August 2018 proposed rule
(83 FR 41912 through 41914) concerning applicability of proposed
policies to Track 1+ Model ACOs.) However, some exceptions to the
otherwise applicable methodology were needed because we proposed to
calculate the expenditures for assigned beneficiaries over the full CY
2019 for purposes of determining shared savings and shared losses for
the 6-month performance year from January 1, 2019 through June 30,
2019. We proposed to use the following steps to calculate shared
savings and shared losses:
Average per capita Medicare expenditures for Parts A and B
services for CY 2019 would be calculated for the ACO's performance year
assigned beneficiary population.
We would compare these expenditures to the ACO's updated
benchmark determined for the calendar year as previously described.
We would apply the MSR and MLR (as applicable).
++ The ACO's assigned beneficiary population for the performance
year starting on January 1, 2019, would be used to determine the MSR
for Track 1 ACOs and the variable MSR/MLR for ACOs in a two-sided model
that selected this option at the start of their agreement period. In
the event a two-sided model ACO selected a fixed MSR/MLR at the start
of its agreement period, and the ACO's performance year assigned
population is below 5,000 beneficiaries, we proposed that the MSR/MLR
would be determined based on the number of assigned beneficiaries as
described in section II.A.6.b. of the August 2018 proposed rule (83 FR
41837 through 41839).

[[Page 59948]]

++ To qualify for shared savings, the ACO's average per capita
Medicare expenditures for its performance year assigned beneficiaries
during CY 2019 must be below its updated benchmark for the year by at
least the MSR established for the ACO.
++ To be responsible for sharing losses with the Medicare program,
the ACO's average per capita Medicare expenditures for its performance
year assigned beneficiaries during CY 2019 must be above its updated
benchmark for the year by at least the MLR established for the ACO.
We would determine the shared savings amount if we
determine the ACO met or exceeded the MSR, and if the ACO met the
minimum quality performance standards established under Sec. 425.502
as described in the August 2018 proposed rule and section V.B.1.c.(4)
of this final rule, and otherwise maintained its eligibility to
participate in the Shared Savings Program. We would determine the
shared losses amount if we determine the ACO met or exceeded the MLR.
To determine these amounts, we would do the following:
++ We would apply the final sharing rate or loss sharing rate to
first dollar savings or losses.
++ For ACOs that generated savings that met or exceeded the MSR, we
would multiply the difference between the updated benchmark
expenditures and performance year assigned beneficiary expenditures by
the applicable final sharing rate based on the ACO's track and its
quality performance as calculated under Sec. 425.502.
++ For ACOs that generated losses that met or exceeded the MLR, we
would multiply the difference between the updated benchmark
expenditures and performance year assigned beneficiary expenditures by
the applicable shared loss rate based on the ACO's track and its
quality performance as calculated under Sec. 425.502 (for ACOs in
tracks where the loss sharing rate is determined based on the ACO's
quality performance).
We would adjust the shared savings amount, if any, for
sequestration by reducing by 2 percent and compare the sequestration-
adjusted shared savings amount to the applicable performance payment
limit based on the ACO's track.
We would compare the shared losses amount, if any, to the
applicable loss sharing limit based on the ACO's track.
We would pro-rate any shared savings amount, as adjusted
for sequestration and the performance payment limit, or any shared
losses amount, as adjusted for the loss sharing limit, by multiplying
by one half, which represents the fraction of the calendar year covered
by the 6-month performance year. This pro-rated amount would be the
final amount of shared savings that would be paid to the ACO for the 6-
month performance year or the final amount of shared losses that would
be owed by the ACO for the 6-month performance year.
We sought comment on these proposals.
Comment: In general, some commenters supported CMS' proposed
policies governing how shared savings and shared losses would be
calculated for the 6-month performance year from January 1, 2019
through June 30, 2019. Some commenters noted there is significant
complexity with this approach and urged CMS to clarify and provide
additional guidance and education to ACOs concerning how certain
operational details will be addressed. Commenters raised concerns about
certain aspects of the methodology for determining quality and
financial performance for a 6-month performance year under the proposed
approach, and other aspects of program participation affected by a 6-
month performance year, which we summarize elsewhere within section
V.B.1.b. and V.B.1.c. of this final rule, including (but not limited
to) the approach to determining beneficiary assignment, flexibilities
for making ACO participant list changes, quality reporting
considerations, and interactions with the Quality Payment Program
policies.
Response: We appreciate commenters' support for the proposed
approach for determining financial and quality performance for the 6-
month performance year from January 1, 2019 through June 30, 2019. As
discussed in the August 2018 proposed rule, we continue to believe in
the importance of using this approach to maintain alignment with
program calculations made on a 12-month basis. This approach maintains
alignment with the program's existing methodology by using 12 months of
expenditure data (for CY 2019) in determining the ACO's financial
performance and a 12-month period for quality measure assessment. In
sections V.B.1.b. and V.B.1.c. of this final rule we respond to
comments on the specific aspects of the methodology for determining
financial and quality performance for the 6-month performance year from
January 1, 2019 through June 30, 2019, and other aspects of program
participation affected by a 6-month performance year. We acknowledge
that this approach will add complexity to program policies and certain
operational processes. To assist ACOs in understanding the operational
details of participation in a 6-month performance year from January 1,
2019 through June 30, 2019, we anticipate providing education and
offering outreach to ACOs on these policies through the various methods
available, including guidance documents, webinars, FAQs and a weekly
newsletter.
Comment: A few commenters expressed support for the proposed
approach to determining beneficiary assignment for the 6-month
performance year from January 1, 2019 through June 30, 2019.
Response: In finalizing the 6-month agreement period extension for
ACOs that started a first or second agreement period on January 1,
2016, we believe it is appropriate to finalize our proposed approach to
determining beneficiary assignment for the performance year from
January 1, 2019 through June 30, 2019. To determine beneficiary
assignment for the 6-month performance year, we proposed to consider
the allowed charges for primary care services furnished to
beneficiaries during a 12-month assignment window, allowing for a 3-
month claims run out. For ACOs under preliminary prospective assignment
with retrospective reconciliation, the assignment window would be CY
2019. For ACOs under prospective assignment, Medicare FFS beneficiaries
would be prospectively assigned to the ACO based on beneficiaries' use
of primary care services in the most recent 12 months for which data
are available. For example, in determining prospective beneficiary
assignment for the January 1, 2019 through June 30, 2019 performance
year, we could use an assignment window from October 1, 2017 through
September 30, 2018, to align with the off-set assignment window
typically used to determine prospective assignment prior to the start
of a calendar year performance year. Beneficiaries would remain
prospectively assigned to the ACO for the performance year unless they
meet any of the exclusion criteria under Sec. 425.401(b) during the
calendar year. This approach would maintain alignment with our
methodology for assigning beneficiaries to ACOs participating in a 12-
month performance year, and allow us to use the same methodology to
determine beneficiary assignment for all ACOs participating in a
performance year beginning January 1, 2019. This approach would also be
consistent with the methodology used to assign beneficiaries for the
historical benchmark period.

[[Page 59949]]

Comment: One commenter noted that the proposal to pro-rate shared
savings and shared losses to reflect the 6-month period of
participation from January 1, 2019 through June 30, 2019, fails to
account for habitual behavior of Medicare beneficiaries. The commenter
explained that most annual wellness visits are performed in the 3rd and
4th quarters of the calendar year, and quarter 1 and quarter 2 of the
calendar year typically show lower healthcare utilization. According to
the commenter, Medicare beneficiaries tend to wait to visit the doctor
until their deductible is met, which usually occurs towards the end of
the calendar year. The commenter indicated that this delay occurs even
for preventive services, like annual wellness visits, that are free at
the point of delivery. The commenter also seems to have an incorrect
understanding that we are using only quarter 1 and quarter 2 data to
determine financial performance for the 6-month performance year from
January 1, 2019 through June 30, 2019, suggesting that an approach that
only accounts for 6 months of expenditures would result in quality and
financial performance determinations that do not fairly reflect the
ACO's quality of care and expenditures for assigned beneficiaries.
Another commenter explained that Medicare expenditures demonstrate
strong and well-known seasonality which would skew performance results
when comparing performance from the first 6 months of the calendar year
against a pro-rated benchmark which represents an annual average.
Response: Under the proposed approach to determining financial and
quality performance for the 6-month performance year from January 1,
2019 through June 30, 2019, as restated in this section of this final
rule, we would continue to determine beneficiary assignment and
expenditures on a 12-month basis. To determine beneficiary assignment,
we would consider the allowed charges for primary care services
furnished to the beneficiary during a 12-month assignment window,
allowing for a 3-month claims run out. We would maintain the calendar
year-based methodology for calculating benchmark expenditures, trend
and update factors, and risk adjustment. To determine shared savings
and shared losses, we would calculate average per capita Medicare
expenditures for Parts A and B services for CY 2019 for the ACO's
performance year assigned beneficiary population and compare this
amount to the updated historical benchmark. We would then pro-rate any
shared savings or shared losses by multiplying the amounts by one-half,
which represents the fraction of the calendar year covered by the 6-
month performance year. We believe this approach addresses the
commenters' concerns, because we would capture assigned beneficiaries'
expenditures for the entire CY 2019, which we would compare to a
benchmark also based on 12 months of expenditures to maintain
consistency and avoid any seasonality or other variation in
expenditures that could result from the use of different timeframes. We
continue to believe that this approach to reconciling ACOs for the 6-
month performance year from January 1, 2019 through June 30, 2019,
based on expenditures for the 12-month period corresponding to CY 2019
would protect the actuarial soundness of the financial reconciliation
methodology.
Comment: A few commenters urged CMS to apply the regional
benchmarking methodology in determining the historical benchmark for
ACOs that first entered the program in 2013 or 2016 that elect a 6-
month extension. One commenter stated that under the program's current
policies, the regional rebasing methodology would apply to ACOs that
renew for a second or third agreement period beginning January 1, 2019.
This commenter also pointed to CMS' proposal in the August 2018
proposed rule to incorporate regional expenditures in benchmark
calculations beginning with an ACO's first agreement period for
agreement periods beginning on July 1, 2019, and in subsequent years to
underscore the urgency for ACOs that may be entering their seventh
performance year of program participation without any regional
adjustment to be under a benchmarking approach that could help to
sustain their accountable care programs and allow them to drive further
cost reductions. Several other commenters suggested that CMS rebase the
historical benchmark for ACOs electing the extension from January 1,
2019 through June 30, 2019, so that the ACO's historical benchmark
years would be 2016, 2017, and 2018 (as opposed to 2013, 2014, and 2015
under the ACO's current agreement period), using a regional rebasing
methodology. One commenter explained that rebasing these ACOs'
benchmarks using regional factors would remove the drawback related to
a delay in agreement period renewal for the organizations on the
leading edge of the Shared Savings Program. This commenter also
explained that benchmark rebasing would account for non-claims based
payments during 2016, 2017, 2018 in the ACO's historical benchmark, and
would eliminate the delay in aligning the benchmark with the full range
of services included in calculating performance year expenditures.
Response: We appreciate the comments, but we decline to accept the
commenters' suggestions to reset the benchmark for ACOs electing the 6-
month extension to their current agreement period. As proposed, the 6-
month extension allows for continued participation under the ACO's
current agreement period, which would not meet the conditions for
applying the program's methodology for rebasing the ACO's historical
benchmark under Sec. 425.603(a). Accordingly, we would continue to
update and adjust the benchmarks for ACOs electing this extension using
the methodology specified under Sec. Sec. 425.602 and 425.603(b), as
applicable. We also note that for ACOs with second agreement periods
beginning on January 1, 2016, that elect the voluntary 6-month
extension, the benchmark rebasing methodology that was used to
determine their benchmark for their second agreement period accounts
for a portion of the savings they generated in their prior agreement
period as an adjustment to their historical benchmark. This adjustment
coupled with the additional time they will be allowed to participate
under their existing historical benchmark should continue to provide a
strong incentive during the extension period.
(2) Use of Authority Under Section 1899(i)(3) of the Act
In the August 2018 proposed rule (83 FR 41851), we explained our
belief that the proposal to determine shared savings and shared losses
for the 6-month performance year starting on January 1, 2019, using
expenditures for the entire CY 2019 and then pro-rating these amounts
to reflect the shorter performance year, requires the use of our
authority under section 1899(i)(3) of the Act to use other payment
models. Section 1899(d)(1)(B)(i) of the Act specifies that, in each
year of the agreement period, an ACO is eligible to receive payment for
shared savings only if the estimated average per capita Medicare
expenditures under the ACO for Medicare FFS beneficiaries for Parts A
and B services, adjusted for beneficiary characteristics, is at least
the percent specified by the Secretary below the applicable benchmark
under section 1899(d)(1)(B)(ii) of the Act. We explained our belief
that the proposed approach to calculating the expenditures for assigned
beneficiaries

[[Page 59950]]

over the full calendar year, comparing this amount to the updated
benchmark for 2019, and then pro-rating any shared savings (or shared
losses, which already are implemented using our authority under section
1899(i)(3) of the Act) for the 6-month performance year involves an
adjustment to the estimated average per capita Medicare Part A and Part
B FFS expenditures determined under section 1899(d)(1)(B)(i) of the Act
that is not based on beneficiary characteristics. Such an adjustment is
not contemplated under the plain language of section 1899(d)(1)(B)(i)
of the Act. As a result, we stated it would be necessary to use our
authority under section 1899(i)(3) of the Act to calculate performance
year expenditures and determine the final amount of any shared savings
(or shared losses) for a 6-month performance year during 2019, in the
proposed manner.
In order to use our authority under section 1899(i)(3) of the Act
to adopt an alternative payment methodology to calculate shared savings
and shared losses for the proposed 6-month performance year from
January 1, 2019 through June 30, 2019, we must determine that the
alternative payment methodology will improve the quality and efficiency
of items and services furnished to Medicare beneficiaries, without
additional program expenditures. We explained our belief that the
proposed approach of allowing ACOs that started a first or second
agreement period on January 1, 2016, to extend their agreement period
for a 6-month performance year and of allowing entry into the program's
redesigned participation options beginning on July 1, 2019, if
finalized, would support continued participation by current ACOs that
must renew their agreements to continue participating in the program,
while also resulting in more rapid progression to two-sided risk by
ACOs within current agreement periods and ACOs entering the program for
an initial agreement period. As discussed in the Regulatory Impact
Analysis of the August 2018 proposed rule (83 FR 41915 through 41928),
we explained our belief that this approach would continue to allow for
lower growth in Medicare FFS expenditures based on projected
participation trends. Therefore, we did not believe that the proposed
methodology for determining shared savings or shared losses for ACOs in
a 6-month performance year during 2019 would result in an increase in
spending beyond the expenditures that would otherwise occur under the
statutory payment methodology in section 1899(d) of the Act. Further,
we noted that the proposed approach to measuring ACO quality
performance for a 6-month performance year based on quality data
reported for CY 2019 would maintain accountability for the quality of
care ACOs provide to their assigned beneficiaries. Participating ACOs
would also have an incentive to perform well on the quality measures in
order to maximize the shared savings they may receive and minimize any
shared losses they may be required to pay in tracks where the loss
sharing rate is determined based on the ACO's quality performance.
Therefore, we noted our expectation that this proposed approach to
reconciling ACOs for a 6-month performance year during 2019 would
continue to lead to improvement in the quality of care furnished to
Medicare FFS beneficiaries.
As discussed in the Regulatory Impact Analysis section of this
final rule (section VII.), we believe the approach to determining
shared savings and shared losses for the 6-month performance year from
January 1, 2019 through June 30, 2019, for ACOs that elect to
voluntarily extend their agreement period meets the requirements for
use of our authority under section 1899(i)(3) of the Act. The
considerations we described in the August 2018 proposed rule were
relevant in making this determination. Specifically, we do not believe
that the methodology for determining shared savings or shared losses
for ACOs in a 6-month performance year from January 1, 2019 through
June 30, 2019, (as finalized in this section) will result in an
increase in spending beyond the expenditures that would otherwise occur
under the statutory payment methodology in section 1899(d) of the Act.
Finalizing the voluntary 6-month extension for ACOs whose agreement
periods expire on December 31, 2018, will support continued
participation by these ACOs, and therefore, also allow for lower growth
in Medicare FFS expenditures based on projected participation trends.
Further, we believe the approach we are finalizing for reconciling ACOs
for a 6-month performance year from January 1, 2019 through June 30,
2019, will lead to continued improvement in the quality of care
furnished to Medicare FFS beneficiaries. As described in section
V.B.1.c.(4) of this final rule, the approach to measuring ACO quality
performance for the 6-month performance year from January 1, 2019
through June 30, 2019, based on quality data reported for CY 2019, will
maintain accountability for the quality of care ACOs provide to their
assigned beneficiaries. Participating ACOs will have an incentive to
perform well on the quality measures in order to maximize the shared
savings they may receive and minimize any shared losses they may be
required to pay in two-sided risk tracks where the loss sharing rate is
determined based on the ACO's quality performance.
(3) Final Policies
After consideration of the public comments received, we are
finalizing, with modifications, the proposed approach to determine
financial and quality performance for ACOs participating in a 6-month
performance year from January 1, 2019 through June 30, 2019, as
specified in paragraphs (a) and (b) of a new section of the regulations
at Sec. 425.609. These modifications are necessary because this final
rule only addresses the 6-month extension period, and does not address
our proposal to establish a July 1, 2019 agreement start date. In
summary, we will do the following to determine an ACO's financial and
quality performance during the 6-month performance year from January 1,
2019 through June 30, 2019: We will compare the ACO's historical
benchmark updated to CY 2019 to the expenditures during CY 2019 for the
ACO's performance year assigned beneficiaries. If the difference is
positive and is greater than or equal to the MSR and the ACO has met
the quality performance standard, the ACO will be eligible for shared
savings. If the ACO is in a two-sided model and the difference between
the updated benchmark and assigned beneficiary expenditures is negative
and is greater than or equal to the MLR (in absolute value terms), the
ACO will be liable for shared losses. ACOs will share in first dollar
savings and losses. The amount of any shared savings will be determined
using the applicable final sharing rate, which is determined based on
the ACO's track for the applicable agreement period, and taking into
account the ACO's quality performance for 2019.
We will adjust the amount of shared savings for sequestration, and
then cap the amount of shared savings at the applicable performance
payment limit for the ACO's track. Similarly, the amount of any shared
losses will be determined using the loss sharing rate for the ACO's
track and, as applicable, for ACOs in tracks with a loss sharing rate
that depends upon quality performance, the ACO's quality performance
for 2019.We will then cap the amount of shared losses at the applicable
loss sharing limit for the ACO's track. We will then pro-rate any
shared savings or shared losses by

[[Page 59951]]

multiplying by one-half, which represents the fraction of the calendar
year covered by the 6-month performance year. This pro-rated amount
will be the final amount of shared savings earned or shared losses owed
by the ACO for the 6-month performance year.
Because we are not addressing the proposed July 1, 2019 agreement
period start date for the proposed new BASIC track and ENHANCED track
at this time, we note the following differences between our proposed
approach (which contemplated that ACOs may be participating in both a
6-month performance year from January 1, 2019 through June 30, 2019,
and a 6-month performance year from July 1, 2019 through December 31,
2019) and our final policies (which are limited to the 6-month
performance year from January 1, 2019 through June 30, 2019, for
eligible ACOs that elect to extend their agreement period, which would
otherwise expire on December 31, 2018):
We are omitting references that we proposed to include in
Sec. 425.609(b) in order to establish the applicability of these
policies to ACOs that begin a 12-month performance year on January 1,
2019, but elect to terminate their participation agreement with an
effective date of termination of June 30, 2019, in order to enter a new
agreement period starting on July 1, 2019 (early renewals). We are also
making clarifying revisions to the introductory text in Sec.
425.609(b).
As described in section V.B.1.c.(4) of this final rule we
are finalizing a subset of our proposals for identifying the ACO
participant list used in determining quality reporting samples for ACOs
participating in a 6-month performance year from January 1, 2019
through June 30, 2019. We are finalizing our proposal to use the ACO's
latest certified ACO participant list (the ACO participant list
effective on January 1, 2019) to determine the quality reporting
samples for the 2019 reporting period.
We are not addressing at this time the proposals for
modifying the MSR/MLR to address small population sizes (83 FR 41837
through 41839). Therefore, the policies for determining shared savings
and shared losses in the event the ACO's assigned population falls
below 5,000, as specified under the program's current regulations at
Sec. 425.110, would apply to ACOs participating in a 6-month
performance year from January 1, 2019 through June 30, 2019. Therefore,
we will specify in Sec. 425.609(b)(3)(ii)(C)(1) that the ACO's
performance year assigned beneficiary population is used to determine
the MSR for Track 1 ACOs and the variable MSR/MLR for ACOs in a two-
sided model that selected this option at the start of their agreement
period. For two-sided model ACOs that selected a fixed MSR/MLR at the
start of the ACO's agreement period, this fixed MSR/MLR is applied. In
the event an ACO's performance year assigned population identified in
Sec. 425.609(b)(1) is below 5,000 beneficiaries, the MSR/MLR is
determined according to Sec. 425.110(b).
We are also reserving paragraph (c) of Sec. 425.609 in
the event that we finalize policies for a second 6-month performance
year during CY 2019 in the future.
In section V.B.1.c. of this final rule, we discuss our decision to
finalize other provisions from the August 2018 proposed rule related to
determining performance for the 6-month performance year, as specified
in paragraphs (d) and (e) of Sec. 425.609.
c. Applicability of Program Policies to ACOs Participating in a 6-Month
Performance Year
In the August 2018 proposed rule (83 FR 41854), we proposed that
program requirements under 42 CFR part 425 that are applicable to the
ACO under the ACO's chosen participation track and based on the ACO's
agreement start date would be applicable to an ACO participating in a
6-month performance year, unless otherwise stated. We received no
comments on this general proposal and we are finalizing this general
approach as proposed. As we explained in the August 2018 proposed rule,
this approach will allow routine program operations to continue to
apply for ACOs participating under a shorter performance year. Further,
it will ensure consistency in the applicability and implementation of
our requirements across all program participants, including ACOs
participating in a 6-month performance year.
In section V.B.1.b. of this final rule, we describe limited
exceptions to our general policies for determining financial and
quality performance which are necessary to ensure calculations can
continue to be performed on a calendar year basis and using the most
relevant data.
In this section, we describe program participation options affected
by our decision to forgo an application cycle in CY 2018 for a January
1, 2019 start date, and offer a voluntary extension to allow ACOs whose
agreement periods expire on December 31, 2018, to continue their
participation in the program for a 6-month performance year from
January 1, 2019 through June 30, 2019. We discuss modifications to
program policies to allow for the 6-month performance year and related
revisions to the program's regulations. As discussed in section
II.A.7.c. of the August 2018 proposed rule (83 FR 41854 through 41860),
these proposals were developed, in part, based on our proposal to offer
an application cycle in CY 2019 for a July 1, 2019 start date.
Therefore, we considered that some ACOs would participate in the
program for both the 6-month performance year (or performance period)
from January 1, 2019 through June 30, 2019, and the 6-month performance
year from July 1, 2019 through December 31, 2019, while other ACOs
would only participate in one of these performance years. In this final
rule, we do not address the considerations related to the proposed July
1, 2019 agreement period start date because we are not addressing the
proposal to offer that start date at this time.
(1) Unavailability of an Application Cycle for Use of a SNF 3-Day Rule
Waiver Beginning January 1, 2019
Eligible ACOs may apply for use of a SNF 3-day rule waiver at the
time of application for an initial agreement or to renew their
participation. Further, as described in sections II.B.2.a. and II.F. of
the August 2018 proposed rule (83 FR 41860, 41912), ACOs within a
current agreement period under Track 3, or the Track 1+ Model may apply
for a SNF 3-day rule waiver, which, if approved, would begin at the
start of their next performance year.
In light of our decision to forgo an application cycle in CY 2018
for a January 1, 2019 agreement period start date, we are also not
offering an opportunity for ACOs to apply for a start date of January
1, 2019, for initial use of a SNF 3-day rule waiver. We proposed that,
if finalized, the next available application cycle for a SNF 3-day rule
waiver would occur in advance of a July 1, 2019 start date. Absent
further rulemaking to establish participation options for a start date
in 2019 that includes an opportunity for ACOs within existing agreement
periods in Track 3 or the Track 1+ Model to apply for a SNF 3-day rule
waiver, these ACOs would not have the opportunity to apply to begin use
of the waiver until January 1, 2020.
(2) Annual Certifications and ACO Participant List Modifications
At the end of each performance year, ACOs complete an annual
certification process. At the same time as this annual certification
process, CMS also requires ACOs to review, certify and electronically
sign official program

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documents to support the ACO's participation for the upcoming
performance year. As we stated in the August 2018 proposed rule (83 FR
41855), requirements for this annual certification, and other
certifications that occur on an annual basis, continue to apply to all
currently participating ACOs in advance of the performance year
beginning on January 1, 2019.
Each ACO is required to certify its list of ACO participant TINs
before the start of its agreement period, before every performance year
thereafter, and at such other times as specified by CMS in accordance
with Sec. 425.118(a). A request to add ACO participants must be
submitted prior to the start of the performance year in which these
additions would become effective. An ACO must notify CMS no later than
30 days after termination of an ACO participant agreement, and the
entity is deleted from the ACO participant list effective as of the
termination date of the ACO participant agreement. Absent unusual
circumstances, the ACO participant list that was certified prior to the
start of the performance year is used to determine beneficiary
assignment for the performance year and therefore also the ACO's
quality reporting samples and financial performance. See Sec.
425.118(b)(3) and see also Medicare Shared Savings Program ACO
Participant List and Participant Agreement Guidance (July 2018, version
5), available at https://www.cms.gov/medicare/medicare-fee-for-service-
payment/sharedsavingsprogram/downloads/aco-participant-list-
agreement.pdf. As we explained in the August 2018 proposed rule (83 FR
41855), these policies would apply for ACOs participating in a 6-month
performance year consistent with the terms of the existing regulations.
As we explained in the August 2018 proposed rule (83 FR 41855),
ACOs that started a first or second agreement period on January 1,
2016, that extend their agreement period for a 6-month performance year
beginning on January 1, 2019, would have the opportunity during 2018 to
make changes to their ACO participant list to be effective for the 6-
month performance year from January 1, 2019, to June 30, 2019. To
prepare for the possible implementation of this 6-month performance
year, we allowed ACOs that started a first or second agreement period
on January 1, 2016, to submit change requests in accordance with usual
program procedures to indicate additions, updates, and deletions to
their existing ACO participant lists, and if applicable, SNF affiliate
lists.
The program's current regulations prevent duplication of shared
savings payments; thus, under Sec. 425.114, ACOs may not participate
in the Shared Savings Program if they include an ACO participant that
participates in another Medicare initiative that involves shared
savings. In addition, under Sec. 425.306(b)(2), each ACO participant
that submits claims for services used to determine the ACO's assigned
population must be exclusive to one Shared Savings Program ACO. If,
during a benchmark or performance year (including the 3-month claims
run out for such benchmark or performance year), an ACO participant
that participates in more than one ACO submits claims for services used
in assignment, then CMS will not consider any services billed through
the TIN of the ACO participant when performing assignment for the
benchmark or performance year; and the ACO may be subject to the pre-
termination actions set forth in Sec. 425.216, termination under Sec.
425.218, or both.
Comment: Some commenters urged CMS to provide ACOs with
opportunities to add and delete ACO participants throughout the
performance years (or performance periods) during 2019 and to clarify
when such opportunities would be available. These commenters urged CMS
to provide additional guidance and education to ACOs on when
participant list changes would be permitted. One commenter suggested
that CMS should provide an additional opportunity for ACOs with
agreement periods expiring on December 31, 2018, to add ACO
participants and/or SNF affiliate TINs and CCNs for performance year
2019 because of the short period of time between the issuance of the
proposed rule (August 9, 2018) and the final deadline for adding ACO
participants for performance year 2019 (September 28, 2018). The
commenter explained that the proposed rule caused confusion and
uncertainty, and as a result, the commenter believes many ACO
participants missed the deadline to be added to the ACO participant
lists of other ACOs. The commenter suggested that we should offer an
additional opportunity to add ACO participants, with the deadline set
for 1 month after publication of a final rule.
Response: During 2018, we allowed ACOs that started a first or
second agreement period on January 1, 2016, to submit ACO participant
change requests in accordance with usual program procedures to indicate
additions, updates, and deletions to their existing ACO participant
lists and, if applicable, SNF affiliate lists. We noted that the final
disposition of any change request submitted by an ACO that started a
first or second agreement period on January 1, 2016, would be
contingent upon issuance of a final rule establishing an opportunity
for these ACOs to continue their participation during 2019 without a
gap in participation. As discussed in section V.B.1. of this final
rule, we are finalizing the proposed 6-month extension for ACOs whose
current participation agreement expire on December 31, 2018.
As a result, all ACOs, including those ACOs that will be eligible
to elect the voluntary 6-month extension that we are finalizing this
final rule, had multiple opportunities to submit change requests to add
ACO participants and/or SNF affiliates for performance years starting
on January 1, 2019. We also launched a new ACO management system during
2018 that is more user friendly, provides faster feedback, and
encourages ACOs to submit change requests to add ACO participants and
SNF affiliates with fewer errors than the system that was available in
previous years. We do not believe it is operationally feasible to
extend the date for ACOs to submit change requests after September 28,
2018, the date we communicated to ACOs as being the deadline to add ACO
participants to be effective for performance years beginning on January
1, 2019. Allowing change requests seeking to add new ACO participants
to be submitted very close to the end of the calendar year would not
provide sufficient time to review and screen providers/suppliers for
program integrity issues and create 2019 assignment list reports, and
may have other operational impacts (such as on timely production of
certain other program reports). We note, however, ACO participants can
be terminated and deleted from the ACO participant list at any time
during a performance year. The ACO participant is no longer an ACO
participant as of the termination effective date of the ACO participant
agreement. Absent unusual circumstances, however, the ACO participant
data will continue to be utilized for certain operational purposes.
(3) Repayment Mechanism Requirements
ACOs must demonstrate that they have in place an adequate repayment
mechanism prior to entering a two-sided model. The repayment mechanism
must be in effect for the duration of an ACO's participation in a two-
sided model and for a sufficient period of time after the conclusion of
the agreement period to permit CMS to calculate the amount of

[[Page 59953]]

shared losses owed and to collect this amount from the ACO (Sec.
425.204(f)(4)). We noted in our ``Repayment Mechanism Arrangements''
guidance document that we would consider this standard to be satisfied
by a repayment mechanism arrangement that remains in effect for 24
months after the end of the agreement period. See Medicare Shared
Savings Program & Medicare ACO Track 1+ Model, Repayment Mechanism
Arrangements, Guidance Document (July 2017, version #6), available at
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/Downloads/Repayment-Mechanism-Guidance.pdf (herein
Repayment Mechanism Arrangements Guidance).
In the August 2018 proposed rule (83 FR 41856), we noted that ACOs
that started a first or second agreement period on January 1, 2016, in
a two-sided model would have in place under current program policies a
repayment mechanism arrangement that would cover the 3 years between
January 1, 2016 and December 31, 2018, plus a 24-month tail period
until December 31, 2020. We would expect an ACO with an agreement
period ending December 31, 2018, that extends its agreement for the 6-
month performance year from January 1, 2019 through June 30, 2019, to
likewise extend the term of its repayment mechanism so that it will be
in effect for the duration of the ACO's participation in a two-sided
model plus 24 months following the conclusion of the agreement period
(that is, until June 30, 2021). This would allow us sufficient time to
perform financial calculations for the 6-month performance year from
January 1, 2019 through June 30, 2019, and to use the arrangement to
collect shared losses for that performance year, if necessary.
In a forthcoming final rule, we expect to summarize and respond to
comments on our proposed changes to Sec. 425.204(f) regarding
repayment mechanism requirements for ACOs that are in a two-sided
model.
Comment: One commenter expressed concern over the lack of current
guidance on the required amount of a repayment mechanism arrangement
(particularly for Track 1+ Model ACOs) and on how to execute changes to
an existing repayment mechanism arrangement in order to support an
ACO's participation during the 6-month performance year from January 1,
2019 through June 30, 2019. The commenter also indicated that changing
repayment mechanism amounts mid-year would likely result in extra costs
to an ACO.
Response: We appreciate the commenter's concern. We may require a
Track 1+ Model ACO to adjust its repayment mechanism amount if, during
the ACO's agreement period, changes in the ACO's participant
composition occur that result in the application of a relatively higher
or lower loss sharing limit. For example, if a Track 1+ Model ACO
reports changes to its composition during the annual certification
process in advance of the next performance year, and we determine that
the ACO no longer qualifies for a revenue-based loss sharing limit, we
may require the ACO to demonstrate that its repayment mechanism is
sufficient to support losses for a higher amount under a benchmark-
based loss sharing limit (83 FR 41841). We will notify an ACO if there
is a significant change in its repayment mechanism amount warranting
modification of its repayment mechanism arrangement and will specify
the process for submitting to us revised repayment mechanism
arrangement documentation for review. With regard to ACOs participating
under Track 2 or Track 3, we clarify that, for the 6-month performance
year from January 1, 2019 through June 30, 2019, we will not require
any such ACO that elects to extend its participation agreement for such
performance year to modify the amount we previously approved for the
ACO's repayment mechanism arrangement.
In addition, we have notified ACOs participating under a two-sided
model that if they elect the 6-month extension from January 1, 2019
through June 30, 2019 then we expect that they will extend their
repayment mechanisms in accordance with Sec. 425.204(f)(4). As we
noted in our Repayment Mechanism Arrangements Guidance, we would
consider Sec. 425.204(f)(4) to be satisfied by a repayment mechanism
arrangement that remains in effect for 24 months after the end of the
agreement period. Accordingly, an ACO participating under a two-sided
model that elects the 6-month extension from January 1, 2019 through
June 30, 2019, should extend the term of its repayment mechanism until
June 30, 2021.
We acknowledge that amending certain repayment mechanism
arrangements could come at additional costs to ACOs. However, we
believe it necessary that the repayment mechanism arrangements comply
with Shared Savings Program and Track 1+ Model policy to ensure the ACO
can repay losses for which it may be liable.
(4) Quality Reporting and Quality Measure Sampling
As described in the August 2018 proposed rule (83 FR 41856 through
41858), to determine an ACO's quality performance for the 6-month
performance year from January 1, 2019 through June 30, 2019, we
proposed to use the ACO's quality performance for the 2019 reporting
period as determined under Sec. 425.502. Under this proposed approach,
we would account for the ACO's quality performance using quality
measure data reported for the 12-month CY 2019.
As we explained in the August 2018 proposed rule, the following
considerations support this proposed approach. For one, use of a 12-
month period for quality measure assessment maintains alignment with
the program's existing quality measurement approach, and aligns with
the proposed use of 12 months of expenditure data (for CY 2019) in
determining the ACO's financial performance. Also, this approach would
continue to align the program's quality reporting period with policies
under the Quality Payment Program. ACO professionals that are MIPS
eligible clinicians (not QPs based on their participation in an
Advanced APM or otherwise excluded from MIPS) would continue to be
scored under MIPS using the APM scoring standard that covers all of
2019. Second, the measure specifications for the quality measures used
under the program require 12 months of data. See for example, the
Shared Savings Program ACO 2018 Quality Measures Narrative
Specification Document (January 20, 2018), available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/Downloads/2018-reporting-year-narrative-specifications.pdf. Third, in light of our proposal to use 12 months of
expenditures (based on CY 2019) in determining shared savings and
shared losses for a 6-month performance year, it would also be
appropriate to hold ACOs accountable for the quality of the care
furnished to their assigned beneficiaries during this same timeframe.
Fourth, and lastly, using an annual quality reporting cycle for the 6-
month performance year would avoid the need to introduce new reporting
requirements, and therefore, potential additional burden on ACOs.
The ACO participant list is used to determine beneficiary
assignment for purposes of generating the quality reporting samples.
Beneficiary assignment is performed using the applicable assignment
methodology under Sec. 425.400, either preliminary prospective
assignment or prospective assignment, with excluded beneficiaries
removed under Sec. 425.401(b), as applicable. The samples for claims-
based measures are typically

[[Page 59954]]

determined based on the assignment list for calendar year quarter 4.
The sample for quality measures reported through the CMS Web Interface
is typically determined based on the beneficiary assignment list for
calendar year quarter 3. The CAHPS for ACOs survey sample is typically
determined based on the beneficiary assignment list for calendar year
quarter 2.
For purposes of determining the quality reporting samples for the
2019 reporting period, we proposed to use the ACO's most recent
certified ACO participant list available at the time the quality
reporting samples are generated, and the assignment methodology most
recently applicable to the ACO for a 2019 performance year. We
explained our belief that the use of the ACO's most recent certified
ACO participant list to assign beneficiaries according to the
assignment methodology applicable based on the ACO's most recent
participation in the program during 2019 would result in the most
relevant beneficiary samples for 2019 quality reporting. Additionally,
we believed this proposed approach to determining the ACO's quality
reporting samples was also appropriate for an ACO that participated in
only one 6-month performance year during 2019 because the most recent
certified ACO participant list applicable for the performance year
would also be the certified ACO participant list that is used to
determine financial performance.
We proposed two approaches to determine the certified ACO
participant list, assignment methodology, and assignment window that
would be used to generate the quality reporting samples for measuring
quality performance of ACOs participating in the 6-month performance
year from January 1, 2019 through June 30, 2019. One approach was
applicable to ACOs that enter a new agreement period under the proposed
July 1, 2019 agreement start date, including ACOs that extended their
prior participation agreement for the 6-month performance year from
January 1, 2019, to June 30, 2019. For ACOs that enter a new agreement
period beginning on July 1, 2019, we proposed to use the certified ACO
participant list for the performance year starting on July 1, 2019, to
determine the quality reporting samples for the 2019 reporting period.
This most recent certified ACO participant list would therefore be used
to determine the quality reporting samples for the 2019 reporting year.
A second approach was proposed for an ACO that extends its
participation for the first 6 months of 2019, but does not enter a new
agreement period beginning on the proposed July 1, 2019 agreement start
date. This second approach is relevant to the policies we are
finalizing in this final rule, for the 6-month performance year from
January 1, 2019 through June 30, 2019, for ACOs whose current
participation agreements expire on December 31, 2018, and that
voluntarily elect to extend their agreement period for a fourth
performance year. Under this approach, we proposed to use the ACO's
latest certified participant list (the ACO participant list effective
on January 1, 2019) to determine the quality reporting samples for the
2019 reporting period. Beneficiary assignment for purposes of
generating the quality reporting samples would be based on the
assignment methodology applicable to the ACO during its 6-month
performance year from January 1, 2019 through June 30, 2019, under
Sec. 425.400, either preliminary prospective assignment or prospective
assignment, with excluded beneficiaries removed under Sec. 425.401(b),
as applicable. We anticipated that the assignment windows for the
quality reporting samples would be as follows, based on our operational
experience: (1) Samples for claims-based measures would be determined
based on the assignment list for calendar year quarter 4; (2) the
sample for CMS Web Interface measures would be determined based on the
assignment list for calendar year quarter 3; and (3) the sample for the
CAHPS for ACOs survey would be determined based on the assignment list
for calendar year quarter 2. We noted that this approach would maintain
alignment with the assignment windows currently used for establishing
quality reporting samples for these measures.
We proposed to specify the certified ACO participant list that
would be used in determining the quality reporting samples for
measuring quality performance for the 6-month performance year from
January 1, 2019 through June 30, 2019, in a new section of the
regulations at Sec. 425.609(b).
Comment: Some commenters requested clarification about how quality
reporting will take place for 6-month performance periods based on 12
months of data. Specifically, these commenters stated their assumption
that all ACOs would only be responsible for reporting quality one time,
during the typical January to March timeframe following the end of
2019. One commenter expressed concern that the proposed approach for
two 6-month performance years and two financial reconciliations for
performance years in CY 2019 would also require two separate quality
reporting samples for measures reported through the CMS Web Interface.
The commenter was concerned about the burden that would be imposed on
ACOs by such a requirement, given that annual quality reporting
requires a significant amount of ACO resources.
Response: We proposed to determine quality performance for the 6-
month performance years during 2019 based on an ACO's quality
performance during the 12-month CY 2019 in order to align with the
program's existing quality reporting methodology, measure
specifications which require 12-months of data, and the APM scoring
standard under MIPS. In addition, because we proposed to use quality
performance during all of CY 2019, we proposed that ACOs would only
have to report quality once for CY 2019, regardless of whether they
complete their participation in the program following the conclusion of
the 6-month performance year from January 1, 2019 through June 30,
2019, or they renew for a new agreement period beginning on July 1,
2019 (if finalized as proposed). Therefore, ACOs participating in the
6-month performance year from January 1, 2019 through June 30, 2019,
and the 6-month performance year from July 1, 2019 through December 31,
2019 (if finalized as proposed), would report quality for one
beneficiary sample for CY 2019.
We also note that for the 2019 reporting period, ACOs would be
required to report quality data through the CMS Web Interface,
according to the method and timing of submission established by CMS.
The period for reporting quality data through the CMS Web Interface
typically occurs for a 12-week period between January and March,
following the conclusion of the calendar year. Thus, ACOs that
participate in a 6-month performance year from January 1, 2019 through
June 30, 2019, along with all other Shared Savings Program ACOs would
be required to report for the 2019 reporting period, and would report
quality data through the CMS Web Interface during the designated
reporting period in early 2020. Further, ACOs participating in the 6-
month performance year from January 1, 201 through June 30, 2019, would
be required to contract with a CMS-approved vendor to administer the
CAHPS for ACOs survey for the 2019 reporting period, consistent with
program-wide policies applicable to all other ACOs. We would apply the
program's sampling methodology, as we have described in the August 2018
proposed rule and this section of this final rule, to determine the
beneficiaries eligible for the samples for claims-based measures (as
calculated by CMS), CMS

[[Page 59955]]

Web Interface reporting, and the CAHPS for ACOs survey.
After consideration of the comments, we are finalizing without
modification our proposal to determine an ACO's quality performance for
the 6-month performance year from January 1, 2019 through June 30,
2019, using the ACO's quality performance for the 12-month CY 2019
(2019 reporting period) as determined under Sec. 425.502. We are also
finalizing a subset of our proposals for identifying the ACO
participant list used in determining quality reporting samples for ACOs
participating in a 6-month performance year from January 1, 2019
through June 30, 2019. Given the limited scope of this final rule we
are finalizing our proposal to use an ACO's latest certified ACO
participant list for the performance year from January 1, 2019 through
June 30, 2019, (the ACO participant list effective on January 1, 2019)
to determine the quality reporting samples for the 2019 reporting
period. We are not addressing at this time our proposals related to the
proposed July 1, 2019 agreement start date, including the policies for
determining the quality reporting samples for ACOs that extend their
participation agreement for the 6-month performance year from January
1, 2019 through June 30, 2019, and continue their participation in the
program in a new agreement period beginning on July 1, 2019. We
anticipate summarizing and responding to comments received on these
proposals in a forthcoming final rule.
(5) Applicability of Extreme and Uncontrollable Circumstances Policies
In section II.E.4 of the August 2018 proposed rule (83 FR 41899
through 41906), we proposed to extend the policies for addressing the
impact of extreme and uncontrollable circumstances on ACO financial and
quality performance results for performance year 2017 to performance
year 2018 and subsequent years. As discussed in section V.B.2.d of this
final rule, we are finalizing this proposal. In section II.E.4. of the
August 2018 proposed rule, we indicated that if finalized, these
policies would apply to ACOs participating in the 6-month performance
year from January 1, 2019 through June 30, 2019.
There were no comments directed specifically at our proposals with
respect to the applicability of these policies for addressing the
impact of extreme and uncontrollable circumstances on ACOs
participating in a 6-month performance year from January 1, 2019
through June 30, 2019. We direct readers to review section V.B.2.d. of
this final rule, for a more comprehensive discussion of the
modifications to the program's extreme and uncontrollable circumstances
policies that we are finalizing with this final rule.
We are finalizing as proposed the policies for determining the
financial and quality performance for the 6-month performance year from
January 1, 2019 through June 30, 2019, for ACOs affected by extreme and
uncontrollable circumstances during CY 2019. In addition, we are also
finalizing our proposal to specify, in a new section of the regulations
at Sec. 425.609(d), the following policies related to determining the
financial and quality performance for the 6-month performance year from
January 1, 2019 through June 30, 2019, for an ACO affected by extreme
and uncontrollable circumstances during CY 2019: (1) In calculating the
amount of shared losses owed by the ACO, CMS makes adjustments to the
amount determined under Sec. 425.609(b), as specified in Sec.
425.606(i) (Track 2) or Sec. 425.610(i) (Track 3), as applicable; and
(2) in determining the ACO's quality performance score for the 2019
quality reporting period, CMS uses the alternative scoring methodology
specified in Sec. 425.502(f).
(6) Payment and Recoupment for 6-Month Performance Years
In the August 2018 proposed rule (83 FR 41858), we proposed
policies regarding CMS' notification to ACOs of shared savings and
shared losses and the timing for ACOs' repayment of shared losses for
both the 6-month performance year (or performance period) from January
1, 2019 through June 30, 2019, and the 6-month performance year from
July 1, 2019 through December 31, 2019.
In this final rule, we are addressing the proposals specific to the
6-month performance year from January 1, 2019 through June 30, 2019. In
a forthcoming final rule, we anticipate discussing comments received on
the proposals related to payment and recoupment for the 6-month
performance year from July 1, 2019 through December 31, 2019, and the
performance period from January 1, 2019 through June 30, 2019, for ACOs
that terminate their agreement effective June 30, 2019, and enter a new
agreement period starting on July 1, 2019. We anticipate this final
rule would include a discussion of our proposal to reduce the shared
savings payment for one 6-month performance year (or performance
period) by the amount of any shared losses owed for the other 6-month
performance year (or performance period).
In the August 2018 proposed rule, we proposed that the following
policies would be applicable to ACOs that elect a 6-month extension for
the performance year from January 1, 2019 through June 30, 2019.
Because we proposed to perform financial reconciliation for this 6-
month performance year after the end of CY 2019, we anticipated that
financial performance reports for the 6-month performance year would be
available in Summer 2020, similar to the expected timeframe for issuing
financial performance reports for the 12-month 2019 performance year
(and for 12-month performance years generally).
We proposed to apply the same policies regarding notification of
shared savings and shared losses and the timing of repayment of shared
losses to ACOs in a 6-month performance year that apply under our
current regulations to ACOs in 12-month performance years. For the 6-
month performance year from January 1, 2019 through June 30, 2019, we
proposed to specify in a new regulation at Sec. 425.609 that CMS would
notify the ACO of shared savings or shared losses, consistent with the
notification requirements specified in Sec. 425.604(f) (Track 1),
Sec. 425.606(h) (Track 2), and Sec. 425.610(h) (Track 3).
Specifically, we proposed that the following approach: (1) CMS notifies
an ACO in writing regarding whether the ACO qualifies for a shared
savings payment, and if so, the amount of the payment due; (2) CMS
provides written notification to an ACO of the amount of shared losses,
if any, that it must repay to the program; (3) if an ACO has shared
losses, the ACO must make payment in full to CMS within 90 days of
receipt of notification.
We proposed to specify policies on payment and recoupment for ACOs
in a 6-month performance year during CY 2019 in a new section of the
regulations at Sec. 425.609(e).
Comment: Some commenters urged CMS to provide additional guidance
and education to ACOs on whether there will be any disruptions in
providing performance results to ACOs participating in a 6-month
performance year in CY 2019.
Response: We anticipate determining financial and quality
performance for ACOs participating in the 6-month performance year from
January 1, 2019 through June 30, 2019, according to the typical annual
projected timeline for making these determinations, and for issuing
performance reports to ACOs. The ACO's annual financial reconciliation
report, quality performance reports, and additional informational
reports and files, are

[[Page 59956]]

typically made available in the summer following the conclusion of a
12-month performance year. We also plan to provide ACOs that
participate in the 6-month performance year from January 1, 2019
through June 30, 2019, quarterly reports for the third and fourth
quarter of CY 2019 (see discussion in section V.B.1.c.(8) of this final
rule). We anticipate that we will make available to ACOs an annual
schedule for report delivery for 2019. For example, see the 2018 Shared
Savings Program report schedule included as Table 12 in the Medicare
Shared Savings Program, Shared Savings and Losses and Assignment
Methodology Specifications (May 2018, version 6) available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/program-guidance-and-specifications.html.
We are finalizing without modification our proposal to specify in a
new section of the regulations at Sec. 425.609(e) that CMS will notify
the ACO of shared savings or shared losses for the 6-month performance
year from January 1, 2019 through June 30, 2019, consistent with the
notification requirements specified in Sec. Sec. 425.604(f),
425.606(h), and 425.610(h), as applicable. Specifically, we will notify
an ACO in writing regarding whether the ACO qualifies for a shared
savings payment, and if so, the amount of the payment due. CMS will
provide written notification to an ACO of the amount of shared losses,
if any, that the ACO must repay to the program. If an ACO has shared
losses, the ACO must make payment in full to CMS within 90 days of
receipt of notification.
(7) Interactions With the Quality Payment Program
In the August 2018 proposed rule (83 FR 41859), we took into
consideration how the proposed July 1, 2019 start date could interact
with other Medicare initiatives, particularly the Quality Payment
Program timelines relating to participation in APMs. In the CY 2018
Quality Payment Program final rule with comment period, we finalized a
policy for APMs that start or end during the QP Performance Period.
Specifically, under Sec. 414.1425(c)(7)(i), for Advanced APMs that
start during the QP Performance Period and are actively tested for at
least 60 continuous days during a QP Performance Period, CMS will make
QP determinations and Partial QP determinations for eligible clinicians
in the Advanced APM using claims data for services furnished during
those dates on which the Advanced APM is actively tested. CMS performs
QP determinations for eligible clinicians in an APM entity three times
during the QP Performance Period using claims data for services
furnished from January 1 through each of the respective QP
determination dates: March 31, June 30, and August 31 (Sec.
414.1425(b)(1)). We explained that this meant that an APM (such as a
two-sided model of the Shared Savings Program) would need to begin
operations by July 1 of a given performance year in order to be
actively tested for at least 60 continuous days before August 31--the
last date on which QP determinations are made during a QP Performance
Period (as specified in Sec. 414.1425(b)(1)). Therefore, we believed
that our proposed July 1, 2019 start date for the proposed new
participation options under the Shared Savings Program would align with
Quality Payment Program rules and requirements for participation in
Advanced APMs. However, we did not address QP determinations for
eligible clinicians participating in an ACO whose agreement period
expires on December 31, 2018, that elects a voluntary extension for the
6-month performance year from January 1, 2019 through June 30, 2019,
and does not continue in the program past June 30, 2019.
Further, as described in section II.A.7.c.(4) of the August 2018
proposed rule (83 FR 41856), our proposal to use a 12-month period for
quality measure assessment for either 6-month performance year during
2019 would maintain alignment with the program's existing quality
measurement approach, and align with the proposed use of 12 months of
expenditure data (for CY 2019) in determining the ACO's financial
performance for a 6-month performance year. Also, this approach would
continue to align the program's quality reporting period with policies
under the Quality Payment Program (83 FR 41856). We explained that ACO
professionals that are MIPS eligible clinicians (not QPs based on their
participation in an Advanced APM or otherwise excluded from MIPS) would
continue to be scored under MIPS using the APM scoring standard that
covers all of 2019.
Comment: One commenter indicated that, as proposed, it appears ACOs
in a two-sided model may lose Advanced APM Entity status and sought
clarity on the Advanced APM status for all participating ACOs. This
commenter was specifically concerned about the Advanced APM status of
the Track 1+ Model.
Response: We believe the comment reflects the need for
clarification about whether eligible clinicians in an ACO that is
participating in a track that meets the Advanced APM criteria and that
elects to extend for the 6-month performance year from January 1, 2019
through June 30, 2019, but does not continue its participation in the
Shared Savings Program past June 30, 2019, would be eligible to become
QPs during the 2019 QP Performance Period. Eligible clinicians who
become QPs will earn the Advanced APM incentive payment and will not be
subject to the MIPS reporting requirements and payment adjustments for
the applicable year. The commenter may have been concerned that an
agreement period that ends prior to the end of the QP performance
period (August 31, 2019) would be considered an early termination and
that the ACO would therefore lose its status as participating in an
Advanced APM, which is not the case under our previously-finalized
policy for Advanced APMs that start or end during a performance period.
For an ACO that is in a track that meets the Advanced APM criteria and
elects to extend for the 6-month performance year from January 1, 2019
through June 30, 2019, the agreement period would end during the QP
performance period. However, because the ACO would have been active for
more than 60 days, it would continue to be an APM entity in an Advanced
APM in 2019 (Sec. 414.1425(c)(7)). Therefore, clinicians who obtain QP
status based on the March 31, 2019, or June 30, 2019 snapshot through
participation in an ACO with a 6-month extension of its agreement
period will: Maintain QP status, be exempt from MIPS, and receive the
APM incentive payment, as long as their ACO completes its agreement
period by remaining in the program through June 30, 2019.
We also believe there is a need to clarify what happens to an
eligible clinician's QP status if they are participating in an ACO that
is in a track that meets the Advanced APM criteria and elects to extend
for the 6-month performance year from January 1, 2019 through June 30,
2019, and either voluntarily terminates or is involuntarily terminated
prior to June 30, 2019. If their ACO terminates or is involuntarily
terminated any time after March 31, 2019, and before August 31, 2019,
then eligible clinicians previously determined to have had QP status
would lose their status as a result of the termination, and would
instead be scored under MIPS using the APM Scoring Standard (Sec.
414.1425(c)(5) and (6)). If their ACO terminates before March 31, 2019,
then the eligible clinicians would not be scored under the APM Scoring
Standard and will be

[[Page 59957]]

assessed under regular MIPS scoring rules (Sec. Sec. 414.1370(e) and
414.1425(b)(1)).
Comment: Some commenters requested clarification on how quality
reporting for a 6-month performance period based on 12-months of data
for 2019 will satisfy the MIPS quality reporting requirements for MIPS
eligible clinicians in ACOs that elect to extend their participation
agreement for the 6-month performance year from January 1, 2019 through
June 30, 2019. One commenter indicated there was no discussion of how
the proposed 6-month extension period would impact scoring under the
APM scoring standard.
Response: We believe the comments reflect the need for
clarification about whether 2019 quality performance for a 6-month
performance year under the Shared Savings Program will count the same
as a full year of performance for purposes of the APM scoring standard
if the ACO ends its current agreement period at the end of the 6-month
extension and chooses to not renew its agreement with a July 1, 2019
start date (if finalized as proposed). That is, would the 2019 quality
reporting for the 6-month performance year count toward the final MIPS
score in the same way that it would for an ACO that is participating in
a full 12-month performance year in the program.
As discussed in this section of this final rule, we are finalizing
a policy of using a 12-month period for quality performance assessment
for the 6-month performance year from January 1, 2019 through June 30,
2019, in order to maintain alignment with the program's existing
quality measurement approach, and with policies under the Quality
Payment Program. ACO professionals that are MIPS eligible clinicians
(not QPs based on their participation in an Advanced APM or otherwise
excluded from MIPS) participating in an ACO that completes a 6-month
performance year from January 1, 2019 through June 30, 2019, would
continue to be scored under MIPS using the APM Scoring Standard, based
on quality data submitted for all of 2019 during the regular submission
period in early 2020. Thus, for a Track 1 ACO in a 6-month performance
year from January 1, 2019 through June 30, 2019, whose agreement period
expires and the ACO does not renew to continue program participation,
the ACO would be scored under the MIPS APM scoring rules for quality
reporting based on the entire CY 2019.
(8) Sharing CY 2019 Aggregate Data With ACOs in 6-Month Performance
Year From January 1, 2019 Through June 30, 2019
Under the program's current regulations at Sec. 425.702, we share
aggregate data with ACOs during the agreement period. This includes
providing data at the beginning of each performance year, during each
quarter, and in conjunction with the annual reconciliation. In the
August 2018 proposed rule (83 FR 41859), for ACOs that started a first
or second agreement period on January 1, 2016, that extend their
agreement for an additional 6-month performance year from January 1,
2019 through June 30, 2019, we proposed to continue to deliver
aggregate reports for all four quarters of CY 2019 based on the ACO
participant list in effect for the 6-month performance year. This would
give ACOs a more complete understanding of the Medicare FFS beneficiary
population that is the basis for reconciliation for the 6-month
performance year by allowing them to continue to receive data,
including demographic characteristics and expenditure/utilization
trends for their assigned population for the entire calendar year. We
believed this proposed approach would allow us to maintain transparency
by providing ACOs with data that relates to the entire period for which
the expenditures for the beneficiaries assigned to the ACO for the 6-
month performance year would be compared to the ACO's benchmark (before
pro-rating any shared savings or shared losses to reflect the length of
the performance year), and maintain consistency with the reports
delivered to ACOs that participate in a 12-month performance year 2019.
Otherwise, we could be limited to providing ACOs with aggregate reports
only for the first and second quarters of 2019, even though under our
proposed methodology for assessing the financial performance of ACOs in
a 6-month performance year, the financial reconciliation for the 6-
month performance year would involve consideration of expenditures from
outside this period during 2019. We proposed to specify this policy in
revisions to Sec. 425.702.
Comment: Some commenters urged CMS to provide additional guidance
and education to ACOs on whether there will be any disruptions in
sharing claims files with ACOs participating in a 6-month performance
year in CY 2019.
Response: In the August 2018 proposed rule, we did not describe in
detail the applicability of the program's policies on sharing
beneficiary-identifiable claims data with ACOs under Sec. 425.704. We
proposed, generally, that unless otherwise stated, program requirements
under 42 CFR part 425 that are applicable to the ACO under the ACO's
chosen participation track and based on the ACO's agreement start date
would be applicable to an ACO participating in a 6-month performance
year. Therefore, we would continue to provide beneficiary-identifiable
claims data (referred to as claim and claim line feed files) to ACOs
only during their participation in the program, including during the 6-
month performance year from January 1, 2019 through June 30, 2019. ACOs
would receive monthly Part A, B and D claim and claim line feed files
during the 6-month performance year based on the ACO participant list
they certify before the start of the performance year. Consistent with
the program's current data sharing policies, we would discontinue
delivery of beneficiary-identifiable data to ACOs when their
participation agreement is no longer in effect.
After consideration of the comments received, we are finalizing our
proposal to deliver to ACOs participating in a 6-month performance year
from January 1, 2019 through June 30, 2019, aggregate reports for all
four quarters of CY 2019 based on the ACO participant list in effect
for the performance year. This policy is specified in revisions to
Sec. 425.702.
(9) Technical or Conforming Changes To Allow for 6-Month Performance
Years
In the August 2018 proposed rule (83 FR 41859 through 41860), we
proposed to make certain technical, conforming changes to certain
provisions of the regulations, including additional changes to
provisions discussed elsewhere in the proposed rule, to reflect our
proposal to add a new provision at Sec. 425.609 to govern the
calculation of the financial and quality results for the proposed 6-
month performance years within CY 2019.
In this final rule, we are addressing only the proposals specific
to the 6-month performance year from January 1, 2019 through June 30,
2019. In a forthcoming final rule, we anticipate discussing comments
received on the proposed 6-month performance year from July 1, 2019
through December 31, 2019, and the proposed 6-month performance period
from January 1, 2019 through June 30, 2019, for ACOs that terminate
their agreement effective June 30, 2019, and enter a new agreement
period starting on July 1, 2019.

[[Page 59958]]

The following proposals discussed in the August 2018 proposed rule
would be applicable to ACOs that elect a 6-month extension for the
performance year from January 1, 2019 through June 30, 2019.
Our proposal that the policies on reopening determinations of
shared savings and shared losses to correct financial reconciliation
calculations (Sec. 425.315) would apply with respect to applicable
payment determinations for performance years within CY 2019. To
clarify, we proposed to amend Sec. 425.315 to incorporate a reference
to the proposed provision for notification of shared savings and shared
losses for ACOs in a 6-month performance year within CY 2019, as
specified in Sec. 425.609(e).
Our proposal to add a reference to Sec. 425.609 in Sec. 425.100
in order to include ACOs that participate in a 6-month performance year
during 2019 in the general description of ACOs that are eligible to
receive payments for shared savings under the program.
Our proposal to amend Sec. 425.400(a)(1)(ii), which describes the
step-wise process for determining beneficiary assignment for each
performance year, to specify that this process would apply to ACOs
participating in a 6-month performance year within CY 2019, and that
assignment would be determined based on the beneficiary's utilization
of primary care services during the entirety of CY 2019, as specified
in Sec. 425.609.
Our proposal to further revise Sec. 425.400(c)(1)(iv), on the use
of certain Current Procedural Terminology (CPT) codes and Healthcare
Common Procedure Coding System (HCPCS) codes in determining beneficiary
assignment, to specify that it would be used in determining assignment
for performance years starting on January 1, 2019, and subsequent
years. We note that we also proposed certain other revisions to this
provision in section II.E.3. of the August 2018 proposed rule (83 FR
41896), as discussed in section V.B.2.c. of this final rule.
Our proposal to revise Sec. 425.401(b), describing the exclusion
of beneficiaries from an ACO's prospective assignment list at the end
of a performance year or benchmark year and quarterly during each
performance year, to specify that these exclusions would occur at the
end of CY 2019 for purposes of determining assignment to an ACO in a 6-
month performance year in accordance with Sec. Sec. 425.400(a)(3)(ii)
and 425.609.
Our proposal, as part of the proposed revisions to Sec.
425.402(e)(2), which, as described in section II.E.2. of the August
2018 proposed rule (83 FR 41894), specifies that beneficiaries who have
designated a provider or supplier outside the ACO as responsible for
coordinating their overall care will not be added to the ACO's list of
assigned beneficiaries for a performance year under the claims-based
assignment methodology, to allow the same policy to apply to ACOs
participating in a 6-month performance year during CY 2019. We are
finalizing our proposed revisions to Sec. 425.402(e)(2), as described
in section V.B.2.b. of this final rule.
Our proposal to revise Sec. 425.404(b), on the special assignment
conditions for ACOs that include FQHCs and RHCs that provide services
used in determining beneficiary assignment, to specify its
applicability in determining assignment for performance years starting
on January 1, 2019, and subsequent performance years.
We also proposed to incorporate references to Sec. 425.609 in the
regulations that govern establishing, adjusting, and updating the
benchmark, including the existing provisions at Sec. Sec. 425.602 and
425.603, to specify that the annual risk adjustment and update to the
ACO's historical benchmark for the 6-month performance year from
January 1, 2019 through June 30, 2019, would use factors based on the
entirety of CY 2019. For clarity and simplicity, we proposed to add a
paragraph to each of these sections to explain the following: (1)
Regarding the annual risk adjustment applied to the historical
benchmark, when CMS adjusts the benchmark for the 6-month performance
year from January 1, 2019 through June 30, 2019, the adjustment will
reflect the change in severity and case mix between benchmark year 3
and CY 2019; (2) Regarding the annual update to the historical
benchmark, when CMS updates the benchmark for the 6-month performance
year from January 1, 2019 through June 30, 2019, the update to the
benchmark will be based on growth between benchmark year 3 and CY 2019.
We also proposed to incorporate references to Sec. 425.609 in the
following provisions regarding the calculation of shared savings and
shared losses: Sec. Sec. 425.604, 425.606, and 425.610. For clarity
and simplicity, we proposed to add a paragraph to each of these
sections explaining that shared savings or shared losses for the 6-
month performance year from January 1, 2019 through June 30, 2019, are
calculated as described in Sec. 425.609. That is, all calculations
will be performed using CY 2019 data in place of performance year data.
There were no comments directed specifically at our proposed
technical and conforming changes to allow for 6-month performance
years. We are finalizing as proposed the technical and conforming
changes to the Shared Savings Program regulations as previously
described in this section of this final rule, to allow them to apply to
ACOs participating in a 6-month performance year from January 1, 2019
through June 30, 2019.
(10) Payment Consequences of Early Termination
In the August 2018 proposed rule (83 FR 41845 through 41847), we
proposed policies to govern the payment consequences of early
termination for performance years beginning in 2019 and subsequent
years, including for ACOs participating in 6-month performance years
from January 1, 2019 through June 30, 2019, and July 1, 2019 through
December 31, 2019, as well as for ACOs participating in 12-month
performance years. We proposed to impose payment consequences for early
termination by holding ACOs in two-sided models liable for pro-rated
shared losses. This approach would apply to ACOs that voluntarily
terminate their participation more than midway through a 12-month
performance year and all ACOs that are involuntarily terminated by CMS.
ACOs would be ineligible to share in savings for a performance year if
the effective date of their termination from the program is prior to
the last calendar day of the performance year; but, we would allow an
exception for ACOs that are participating in a 12-month performance
year under the program as of January 1, 2019, that terminate their
agreement with an effective date of June 30, 2019, and enter a new
agreement period under the proposed BASIC track or ENHANCED track
beginning July 1, 2019. In these cases, we would perform separate
reconciliations to determine shared savings and shared losses for the
ACO's first 6 month period of participation in 2019 and for the ACO's
6-month performance year from July 1, 2019, to December 31, 2019, under
the subsequent participation agreement.
In a forthcoming final rule we anticipate addressing comments
received on proposals for the payment consequences of early termination
from 12-month performance years and from 6-month performance years
beginning on July 1, 2019, should we finalize the proposal to offer a
July 1, 2019 start date for the new participation options. Therefore,
in this section of this final rule we focus specifically on the
proposals regarding the payment consequences of early termination as
they relate to the 6-month performance

[[Page 59959]]

year from January 1, 2019 through June 30, 2019.
We proposed that an ACO would be eligible to receive shared savings
for a 6-month performance year during 2019 if it completes the term of
the performance year, regardless of whether the ACO chooses to continue
its participation in the program. That is, we would reconcile ACOs that
started a first or second agreement period January 1, 2016, that extend
their agreement period for a fourth performance year, and complete this
performance year (concluding on June 30, 2019).
For an ACO that participates for a portion of a 6-month performance
year during 2019, we proposed the following: (1) If the ACO terminates
its participation agreement effective before the end of the performance
year, we would not reconcile the ACO for shared savings or shared
losses (if a two-sided model ACO); (2) if CMS terminates a two-sided
model ACO's participation agreement effective before the end of the
performance year, the ACO would not be eligible for shared savings and
we would reconcile the ACO for shared losses and pro-rate the amount
reflecting the number of months during the performance year that the
ACO was in the program. We proposed to specify these policies in
amendments to Sec. 425.221(b).
We also proposed to revise the regulation at Sec. 425.221 to
streamline and reorganize the provisions in paragraph (b), which we
believed necessary to incorporate the proposed new requirements. We
sought comment on these proposals.
We are not addressing our proposed modifications to program
policies to impose payment consequences for early termination in this
final rule. Accordingly, for ACOs participating in a performance year
starting on January 1, 2019, we will continue to apply the program's
current policies for payment consequences of early termination. We
believe that continuing to use the current approach would be simpler,
both from the standpoint of CMS as the regulatory entity and operator
of the program, and for ACOs as regulated entities already familiar
with the current policies. Under this approach, ACOs that terminate
from a performance year starting on January 1, 2019, with an effective
date of termination prior to the end of their performance year will not
be eligible for shared savings or accountable for shared losses.
At this time, we are finalizing a subset of our proposed policies
for determining payment consequences of early termination, to account
for ACOs participating in a 6-month performance year from January 1,
2019 through June 30, 2019. Specifically, we are finalizing without
modification our proposal that an ACO participating in a 6-month
performance year from January 1, 2019 through June 30, 2019, is
eligible for shared savings if the following conditions are met: CMS
has designated or approved an effective date of termination that is the
last calendar day of the performance year (June 30, 2019); the ACO has
completed all close-out procedures specified in Sec. 425.221(a) by the
deadline specified by CMS (if applicable); and the ACO has satisfied
the criteria for sharing in savings for the performance year.
Consistent with our existing policies, if the participation agreement
is terminated at any time by CMS under Sec. 425.218, the ACO will not
be eligible to receive shared savings for the performance year during
which the termination becomes effective, and will not be accountable
for any shared losses. Further, for an ACO participating in a 6-month
performance year from January 1, 2019 through June 30, 2019, that
elects to terminate early, we will apply the payment consequences of
early termination consistent with the current regulations, and the ACO
will not be eligible to receive shared savings for the performance year
and will not be accountable for any shared losses.
We are finalizing the proposed revisions to Sec. 425.221 to allow
us to consistently apply current program policies on the payment
consequences of early termination or agreement expiration to ACOs in a
6-month performance year from January 1, 2019 through June 30, 2019. We
are amending Sec. 425.221(b) to remove references to December 31st of
a performance year and instead to refer to the last calendar day of the
performance year, so that the regulatory provisions will apply to ACOs
regardless of whether they are participating in a 12-month or 6-month
performance year. We are not addressing at this time the other proposed
revisions to the regulation at Sec. 425.221, including the proposals
to streamline and reorganize the provisions in paragraph (b).
2. Updating Program Policies
a. Overview
This section addresses various proposed revisions described in the
August 2018 proposed rule (83 FR 41894 through 41911) that are designed
to update policies under the Shared Savings Program. We proposed to
revise our regulations governing the assignment process in order to
align our voluntary alignment policies with the requirements of section
50331 of the Bipartisan Budget Act of 2018 and to update the definition
of primary care services. We also proposed to extend the policies that
we recently adopted for ACOs impacted by extreme and uncontrollable
circumstances during 2017 to 2018 and subsequent performance years. We
also solicited comment on considerations related to supporting ACOs'
activities to address the national opioid crisis and the agency's
meaningful measures initiative. We proposed to discontinue use of the
quality performance measure that assesses the level of adoption of
CEHRT by the eligible clinicians in an ACO and proposed instead that
ACOs be required to certify upon application to participate in the
Shared Savings Program and annually thereafter that the percentage of
eligible clinicians participating in the ACO using CEHRT to document
and communicate clinical care to their patients or other health care
providers meets or exceeds certain thresholds.
b. Revisions to Policies on Voluntary Alignment
(1) Background
Section 50331 of the Bipartisan Budget Act of 2018 amended section
1899(c) of the Act (42 U.S.C. 1395jjj(c)) to add a new paragraph (2)(B)
that requires the Secretary, for performance year 2018 and each
subsequent performance year, to permit a Medicare FFS beneficiary to
voluntarily identify an ACO professional as the primary care provider
of the beneficiary for purposes of assigning such beneficiary to an
ACO, if a system is available for electronic designation. A voluntary
identification by a Medicare FFS beneficiary under this provision
supersedes any claims-based assignment otherwise determined by the
Secretary. Section 50331 also requires the Secretary to establish a
process under which a Medicare FFS beneficiary is notified of his or
her ability to designate a primary care provider or subsequently to
change this designation. An ACO professional is defined under section
1899(h) of the Act as a physician as defined in section 1861(r)(1) of
the Act and a practitioner described in section 1842(b)(18)(C)(i) of
the Act.
As we stated in the August 2018 proposed rule (83 FR 41894), we
believe that section 50331 requires certain revisions to our current
beneficiary voluntary alignment policies in Sec. 425.402(e). Prior to
enactment of the Bipartisan Budget Act of 2018, section 1899(c) of the
Act required that beneficiaries be assigned to an ACO based on their
use of primary care services furnished by a physician as

[[Page 59960]]

defined in section 1861(r)(1) of the Act, and beginning January 1,
2019, services provided in RHCs/FQHCs. In order to satisfy this
statutory requirement, we currently require that a beneficiary receive
at least one primary care service during the beneficiary assignment
window from an ACO professional in the ACO who is a physician with a
specialty used in assignment in order to be assigned to the ACO (see
Sec. 425.402(b)(1)). As currently provided in Sec. 425.404(b), for
performance year 2019 and subsequent performance years, for purposes of
the assignment methodology in Sec. 425.402, CMS treats a service
reported on an FQHC/RHC claim as a primary care service performed by a
primary care physician. After identifying the beneficiaries who have
received a primary care service from a physician in the ACO, we use a
two-step, claims-based methodology to assign beneficiaries to a
particular ACO for a calendar year (see Sec. 425.402(b)(2) through
(4)). In the CY 2017 PFS final rule (81 FR 80501 through 80510), we
augmented this claims-based beneficiary assignment methodology by
finalizing a policy under which beneficiaries, beginning in 2017 for
assignment for performance year 2018, may voluntarily align with an ACO
by designating a ``primary clinician'' they believe is responsible for
coordinating their overall care using MyMedicare.gov, a secure online
patient portal. MyMedicare.gov contains a list of all of the Medicare-
enrolled practitioners who appear on the Physician Compare website and
beneficiaries may choose any practitioner present on Physician Compare
as their primary clinician.
Notwithstanding the assignment methodology in Sec. 425.402(b),
beneficiaries who designate an ACO professional whose services are used
in assignment as responsible for their overall care will be
prospectively assigned to the ACO in which that ACO professional
participates, provided the beneficiary meets the eligibility criteria
established at Sec. 425.401(a) and is not excluded from assignment by
the criteria in Sec. 425.401(b), and has had at least one primary care
service during the assignment window with an ACO professional in the
ACO who is a primary care physician as defined under Sec. 425.20 or a
physician with one of the primary specialty designations included in
Sec. 425.402(c) (see Sec. 425.402(e)). Such beneficiaries will be
added prospectively to the ACO's list of assigned beneficiaries for the
subsequent performance year, superseding any assignment that might have
otherwise occurred under the claims-based methodology. Further,
beneficiaries may change their designation at any time through
MyMedicare.gov; the new choice will be incorporated when we perform
assignment for the subsequent performance year. Beneficiaries who
designate a provider or supplier outside an ACO, who is a primary care
physician, a physician with a specialty designation that is considered
in the assignment methodology, or a nurse practitioner, physician
assistant, or clinical nurse specialist, as responsible for
coordinating their overall care will not be added to an ACO's list of
assigned beneficiaries, even if they would otherwise meet the criteria
for claims-based assignment.
(2) Summary of Proposed Revisions
Section 1899(c) of the Act, as amended by section 50331 of the
Bipartisan Budget Act of 2018, requires the Secretary to permit a
Medicare FFS beneficiary to voluntarily identify an ACO professional as
their primary care provider for purposes of assignment to an ACO. Under
our current methodology, a beneficiary may select any practitioner who
has a record on the Physician Compare website as their primary
clinician; however, we will only assign the beneficiary to an ACO if
they have chosen a practitioner who is a primary care physician (as
defined at Sec. 425.20), a physician with one of the primary specialty
designations included in Sec. 425.402(c), or a nurse practitioner,
physician assistant, or clinical nurse specialist. Therefore, we
proposed to modify our current voluntary alignment policies at Sec.
425.402(e)(2)(iii) to provide that we will assign a beneficiary to an
ACO based upon their selection of any ACO professional, regardless of
specialty, as their primary clinician. Under this proposal, a
beneficiary may select a practitioner with any specialty designation,
for example, a specialty of allergy/immunology or surgery, as their
primary care provider and be eligible for assignment to the ACO in
which the practitioner is an ACO professional. Specifically, we
proposed to revise Sec. 425.402(e)(2)(iii) to remove the requirement
that the ACO professional designated by the beneficiary be a primary
care physician as defined at Sec. 425.20, a physician with a specialty
designation included at Sec. 425.402(c), or a nurse practitioner,
physician assistant, or clinical nurse specialist. In addition, the
provision at Sec. 425.402(e)(2)(iv) addresses beneficiary designations
of clinicians outside the ACO as their primary clinician. The current
policy at Sec. 425.402(e)(2)(iv) provides that a beneficiary will not
be assigned to an ACO for a performance year if the beneficiary has
designated a provider or supplier outside the ACO who is a primary care
physician as defined at Sec. 425.20, a physician with a specialty
designation included at Sec. 425.402(c), or a nurse practitioner,
physician assistant, or clinical nurse specialist as their primary
clinician responsible for coordinating their overall care. Consistent
with the proposed revisions to Sec. 425.402(e)(2)(iii) to incorporate
the requirements of section 50331 of the Bipartisan Budget Act, we
proposed to revise Sec. 425.402(e)(2)(iv) to indicate that if a
beneficiary designates any provider or supplier outside the ACO as
their primary clinician responsible for coordinating their overall
care, the beneficiary will not be added to the ACO's list of assigned
beneficiaries for a performance year.
Section 1899(c) of the Act, as amended by section 50331 of the
Bipartisan Budget Act of 2018, requires the Secretary to allow a
beneficiary to voluntarily align with an ACO, and does not impose any
restriction with respect to whether the beneficiary has received any
services from an ACO professional (see section 1899(c)(2)(B)(i) of the
Act). As we explained in the August 2018 proposed rule (83 FR 41895),
we believe the requirement in section 1899(c)(2)(B)(iii) of the Act
that a beneficiary's voluntary identification shall supersede any
claims-based alignment is also consistent with eliminating the
requirement that the beneficiary have received a service from an ACO
professional in order to be eligible to be assigned an ACO. Therefore,
we proposed to remove the requirement at Sec. 425.402(e)(2)(i) that a
beneficiary must have received at least one primary care service from
an ACO professional who is either a primary care physician or a
physician with a specialty designation included in Sec. 425.402(c)
within the 12-month assignment window in order to be assigned to the
ACO. Under this proposal, a beneficiary who selects a primary clinician
who is an ACO professional, but who does not receive any services from
an ACO participant during the assignment window, will remain eligible
for assignment to the ACO. We stated that we believe this approach
would reduce burden on beneficiaries and their practitioners by not
requiring practitioners to provide unnecessary care during a specified
period of time in order for a beneficiary to remain eligible for
assignment to the ACO. Consistent with this proposal, we proposed to
remove Sec. 425.402(e)(2)(i) in its entirety.

[[Page 59961]]

We noted that, under this proposal, if a beneficiary does not
change their primary clinician designation, the beneficiary will remain
assigned to the ACO in which that practitioner participates during the
ACO's entire agreement period and any subsequent agreement periods
under the Shared Savings Program, even if the beneficiary no longer
seeks care from any ACO professionals. Because a beneficiary who has
voluntarily identified a Shared Savings Program ACO professional as
their primary care provider will remain assigned to the ACO regardless
of where they seek care, this proposed change could also impact
assignment under certain Innovation Center models in which overlapping
beneficiary assignment is not permitted. As we explained in the August
2018 proposed rule (83 FR 41895), we believe our proposed policy is
consistent with the requirement under section 1899(c)(2)(B)(iii) of the
Act that a voluntary identification by a beneficiary shall supersede
any claims-based assignment. However, we also believe it could be
appropriate, in limited circumstances, to align a beneficiary to an
entity participating in certain specialty and disease-specific
Innovation Center models, such as the Comprehensive ESRD Care (CEC)
Model. CMS implemented the CEC Model to test a new system of payment
and service delivery that CMS believes will lead to better health
outcomes for Medicare beneficiaries living with ESRD, while lowering
costs to Medicare Parts A and B. Under the model, CMS is working with
groups of health care providers, dialysis facilities, and other
suppliers involved in the care of ESRD beneficiaries to improve the
coordination and quality of care that these individuals receive. We
believe that an ESRD beneficiary, who is otherwise eligible for
assignment to an entity participating in the CEC Model, could benefit
from the focused attention on and increased care coordination for their
ESRD available under the CEC Model. Such a beneficiary could be
disadvantaged if they were unable to receive the type of specialized
care for their ESRD that will be available from an entity participating
in the CEC Model. Furthermore, we believe it could be difficult for the
Innovation Center to conduct a viable test of a specialty or disease-
specific model, if we were to require that beneficiaries who have
previously designated an ACO professional as their primary clinician
remain assigned to the Shared Savings Program ACO under all
circumstances. Currently, the CEC Model completes its annual PY
prospective assignment lists prior to the Shared Savings Program in
order to identify the beneficiaries who may benefit from receiving
specialized care from an entity participating in the CEC Model.
Additionally, on a quarterly basis, a beneficiary may be assigned to
the CEC Model who was previously assigned to a Track 1 or Track 2 ACO.
As a result, we believe that in some instances it may be necessary
for the Innovation Center to use its authority under section
1115A(d)(1) of the Act to waive the requirements of section
1899(c)(2)(B) of the Act solely as necessary for purposes of testing a
particular model. Therefore, we proposed to create an exception to the
general policy that a beneficiary who has voluntarily identified a
Shared Savings Program ACO professional as their primary care provider
will remain assigned to the ACO regardless of where they seek care.
Specifically, we proposed that we would not assign such a beneficiary
to the ACO when the beneficiary is also eligible for assignment to an
entity participating in a model tested or expanded under section 1115A
of the Act under which claims-based assignment is based solely on
claims for services other than primary care services and for which
there has been a determination by the Secretary that a waiver under
section 1115A(d)(1) of the Act of the requirement in section
1899(c)(2)(B) of the Act is necessary solely for purposes of testing
the model. Under this proposal, if a beneficiary selects a primary
clinician who is a Shared Savings Program ACO professional and the
beneficiary is also eligible for alignment to a specialty care or
disease specific model tested or expanded under section 1115A of the
Act under which claims-based assignment is based solely on claims for
services other than primary care services and for which there has been
a determination that a waiver of the requirement in section
1899(c)(2)(B) is necessary solely for purposes of testing the Model,
the Innovation Center or its designee would notify the beneficiary of
their alignment to an entity participating in the model. Additionally,
although such a beneficiary may still voluntarily identify his or her
primary clinician and may seek care from any clinician, the beneficiary
would not be assigned to a Shared Savings Program ACO even if the
designated primary clinician is an ACO professional in a Shared Savings
Program ACO.
In the August 2019 proposed rule (83 FR 41896), we indicated that
we would include a list of any models that meet these criteria on the
Shared Savings Program website, to supplement the information already
included in the beneficiary assignment reports we currently provide to
ACOs (as described under Sec. 425.702(c)), so that ACOs can know why
certain beneficiaries, who may have designated an ACO professional as
their primary clinician, are not assigned to them. Similar information
would also be shared with 1-800-MEDICARE to ensure that Medicare
customer service representatives are able to help beneficiaries who may
be confused as to why they are not aligned to the ACO in which their
primary clinician is participating.
Section 1899(c)(2)(B)(ii) of the Act, as amended by section 50331
of the Bipartisan Budget Act, requires the Secretary to establish a
process under the Shared Savings Program through which each Medicare
FFS beneficiary is notified of the ability to identify an ACO
professional as his or her primary care provider and informed of the
process that may be used to make and change such identification. In the
August 2018 proposed rule (83 FR 41896), we stated our intent to
implement section 1899(c)(2)(B)(ii) of the Act under the beneficiary
notification process at Sec. 425.312. We are not addressing this topic
at this time. We will summarize and respond to public comments on this
proposed policy in a forthcoming final rule.
We proposed to apply these modifications to our policies under the
Shared Savings Program regarding voluntary alignment beginning for
performance years starting on January 1, 2019, and subsequent
performance years. We proposed to incorporate these new requirements in
the regulations by redesignating Sec. 425.402(e)(2)(i) through (iv) as
Sec. 425.402(e)(2)(i)(A) through (D), adding a paragraph heading for
newly redesignated Sec. 425.402(e)(2)(i), and including a new Sec.
425.402(e)(2)(ii).
We noted that as specified in Sec. 425.402(e)(2)(ii) a beneficiary
who has designated an ACO professional as their primary clinician must
still be eligible for assignment to an ACO by meeting the criteria
specified in Sec. 425.401(a). These criteria establish the minimum
requirements for a beneficiary to be eligible to be assigned to an ACO
under our existing assignment methodology, and we believe it is
appropriate to impose the same basic limitations on the assignment of
beneficiaries on the basis of voluntary alignment. We do not believe it
would be appropriate, for example, to assign a beneficiary to an ACO if
the beneficiary does not reside in the United States, or if the other
eligibility requirements are not met.

[[Page 59962]]

We requested comments on our proposals to implement the new
requirements governing voluntary alignment under section 50331 of the
Bipartisan Budget Act of 2018. We also sought comment on our proposal
to create a limited exception to our proposed policies on voluntary
alignment to allow a beneficiary to be assigned to an entity
participating in a model tested or expanded under section 1115A of the
Act when certain criteria are met. In addition, we welcomed comments on
how we might increase beneficiary awareness and further improve the
electronic process through which a beneficiary may voluntarily identify
an ACO professional as their primary care provider through
My.Medicare.gov for purposes of assignment to an ACO.
Comment: Many commenters supported the proposed policies to
implement the new requirements governing voluntary alignment under
section 50331 of the Bipartisan Budget Act of 2018. In particular, many
commenters supported the proposal to remove the requirement that a
beneficiary must have received at least one primary care service from
an ACO professional who is either a primary care physician or a
physician with a specialty designation included in Sec. 425.402(c)
within the 12-month assignment window in order to be assigned to the
ACO. Commenters were in favor of removing this requirement because it
would allow a beneficiary to select a NP, PA, or CNS, who is
participating in an ACO, as their primary clinician to voluntarily
align to the ACO even if they do not receive care from any physicians
participating in the ACO. Commenters suggested this more inclusive
policy supports CMS' goals of improving patient access and quality of
care, and is consistent with patient-centered health care delivery.
Additionally, some commenters specifically supported the proposal to
allow a beneficiary to voluntarily designate any ACO professional,
regardless of specialty, as their primary care provider for purposes of
assignment to an ACO. In particular, commenters representing
neurologists and palliative care practitioners were supportive of this
proposed change. In addition, one commenter agreed that the proposed
policy would allow ``the opportunity for patients to choose and
establish a medical home with their clinician.'' The commenter also
supported voluntary alignment because it results in prospective
beneficiary attribution, which the commenter preferred over the
preliminary prospective assignment methodology with retrospective
reconciliation.
Response: We appreciate the commenters' support for the proposed
policies to implement the new requirements governing voluntary
alignment under section 50331 of the Bipartisan Budget Act of 2018.
Comment: A few commenters proposed a change to section
1899(h)(1)(A) of the Act. Section 1899(c) of the Act requires the
Secretary to determine an appropriate method to assign Medicare FFS
beneficiaries to an ACO based on their utilization of primary care
services provided under this title by an ACO professional described in
subsection (h)(1)(A). Section 1899(h)(1)(A) of the Act constitutes one
element of the definition of the term ``ACO professional''.
Specifically, this provision establishes that a physician (as defined
in section 1861(r)(1)) is an ACO professional for purposes of the
Shared Savings Program. Section 1861(r)(1) of the Act in turn defines
the term physician as a doctor of medicine or osteopathy legally
authorized to practice medicine and surgery by the State in which he
performs such function or action. One commenter proposed a change to
allow for ``private NP led practices and NP led clinics'' to be
included as ACO professionals described in section 1899(h)(1)(A) of the
Act. The commenter recommended this change in particular for rural
areas, stating that NPs account for 1 in 4 medical providers in rural
areas.
Response: Because commenters are requesting a change to the
statute, these suggestions are outside the scope of this final rule.
However, as many commenters noted above, the proposed changes to the
voluntary alignment methodology will allow a beneficiary to align with
a NP, PA, or CNS participating in an ACO and ultimately be assigned to
the ACO regardless of whether they receive care from a physician in the
ACO. Additionally, we agree these non-physician practitioners play an
important role in coordinating patient care and providing primary care
services, as such we have included primary care services furnished by
NPs, PAs, and CNSs in step 1 of our two-step claims-based assignment
methodology (see Sec. 425.402(b)).
Comment: Some commenters opposed the proposed changes to the
voluntary alignment methodology. One commenter expressed concern about
beneficiary confusion if their practitioners participate in different
ACOs or the beneficiary selects a practitioner outside of an ACO as
their primary care provider. Similarly, one commenter expressed concern
about an ACO's ability to maintain an assigned population of 5,000
beneficiaries if beneficiaries can select any ACO professional
regardless of specialty as their primary care provider. A few
commenters disagreed with including all practitioner specialties citing
differences in training, education, knowledge, and experience. Another
commenter expressed concern about whether specialists are willing to
take on the role of a primary care physician and manage the overall
care of beneficiaries assigned to the ACO through voluntary alignment.
Some commenters disagreed with the proposal to remove the requirement
that a beneficiary receive a primary care service from an ACO
professional, with a physician specialty used in assignment, during the
assignment window. One commenter stated that removing the requirement
would exacerbate a ``leakage'' problem that they described as a
scenario where assigned beneficiaries receive some or all of their care
from providers and suppliers outside the ACO. One commenter suggested
beneficiaries should be required to renew their selection of their
primary care clinician one year following the beneficiary's entry into
a long-term care setting. Another commenter suggested that
beneficiaries who voluntarily align with an ACO be required to receive
a minimum number of primary care services from ACO professionals within
the same ACO in order to remain aligned to the ACO.
Response: We disagree with these comments. We believe that when a
beneficiary selects a primary clinician, they are identifying their
primary care provider, regardless of specialty or whether the
beneficiary has received a recent primary care service. We believe they
are informing CMS that they view the practitioner as their primary care
provider and responsible for managing their overall care. We also
believe all practitioners, regardless of specialty, play an important
role in coordinating care for beneficiaries and if a beneficiary
selects a practitioner as their primary clinician, the beneficiary
should be treated as having made an informed election. Although we
understand the concern that an ACO could lose assigned beneficiaries
due to their voluntary alignment with another ACO, we note that our
experience to date shows that the majority of beneficiaries who
voluntarily align to an ACO would have been assigned to the same ACO
via our two-step claims-based assignment methodology under Sec.
425.402(b). We

[[Page 59963]]

also believe requiring beneficiaries to renew their primary clinician
selection would create additional unnecessary burden on beneficiaries.
Beneficiaries who have designated a primary clinician must have
established a MyMedicare.gov account, which likely indicates that they
are actively engaged in reviewing and managing their health
information. We believe these engaged beneficiaries will also manage
and update their primary clinician selections as necessary. We also
disagree with establishing a requirement that a beneficiary receive a
minimum number of primary care services from ACO providers/suppliers in
the ACO in order to honor a beneficiary's voluntary alignment
selection. We believe our proposed approach is in accordance with the
requirement under section 1899(c) of the Act, as amended by section
50331 of the Bipartisan Budget Act of 2018, that primary care provider
selections take precedence over any claims-based assignment.
Comment: A few commenters suggested CMS simplify the process by
which a beneficiary selects their primary clinician. Commenters
suggested that, in addition to the electronic means of voluntary
alignment, CMS allow beneficiaries to voluntarily align with their
primary clinician through the ACO, at the point of care, through 1-800
Medicare, a smart phone application, or Physician Compare. One
commenter noted they had experienced difficulties with CMS'
operationalization of the voluntary alignment policy through
MyMedicare.gov.
Response: Currently, if beneficiaries need help in designating a
primary clinician, they can call 1-800 Medicare to have a
representative walk them through the process or use the ``Empowering
Patients to Make Decisions About Their Healthcare: Register for
MyMedicare.gov and Select Your Primary Clinician'' fact sheet available
at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/Downloads/vol-alignment-bene-fact-sheet.pdf. We
plan to continue to make refinements to our implementation of voluntary
alignment in order to improve the user experience for beneficiaries and
will take the commenters' suggestions into consideration in developing
future policies regarding voluntary alignment.
Comment: One commenter disagreed with allowing beneficiaries to
voluntarily align with an ACO professional. The commenter cited
difficulty tracking the cost of beneficiaries who are not assigned to
an ACO through our two-step claims-based assignment methodology.
Another commenter suggested we not hold an ACO accountable for a
voluntarily aligned beneficiary for a performance year if the
beneficiary does not receive any services from their primary clinician
in the ACO during that performance year. Another commenter opposed
voluntary alignment because they believe the costs for voluntarily
aligned beneficiaries are not reflected in an ACO's historical
benchmark.
Response: Consistent with section 1899(c)(2)(B)(i) of the Act, we
are required to allow beneficiaries to voluntarily identify an ACO
professional as their primary care provider for purposes of assignment
to an ACO if a system is available for electronic designation. To aid
ACOs in identifying and tracking costs and Medicare services for
voluntarily aligned beneficiaries, we provide ACOs with quarterly
aggregate reports (see Sec. 425.702) that identify beneficiaries who
have voluntarily aligned with the ACO, as well as monthly claim and
claim line feed files (see Sec. 425.704) to aid ACOs in their
operations. Additionally, as previously stated, we have found the
majority of beneficiaries who voluntarily align to an ACO would have
been assigned to the same ACO in the applicable performance year based
on our two-step assignment methodology. As required under section
1899(b)(2)(A) of the Act and the regulation at Sec. 425.100(a), ACOs
participating in the Shared Savings Program must agree to become
accountable for the quality, cost, and overall care of the Medicare
fee-for-service beneficiaries assigned to the ACO. Beneficiaries who
voluntarily align to an ACO are prospectively assigned to the ACO for
the performance year. Under the prospective assignment methodology,
ACOs are accountable for their assigned beneficiary population
regardless of where the beneficiaries receive the plurality of their
primary care services during the performance year. We believe this is
an appropriate approach when a beneficiary selects a practitioner as
their primary clinician. As we stated earlier, we believe that when a
beneficiary selects a primary clinician, the beneficiary is making an
informed decision and identifying for CMS the provider or supplier whom
they consider to be responsible for managing their overall care. The
historical benchmark reflects the beneficiary population who received
the plurality of their primary care services from the ACO during the
three benchmark years and, in our experience, there is a high
correlation between the beneficiaries who are assigned based on our
two-step claims-based assignment methodology and voluntarily aligned
beneficiaries. As a result, we believe our current benchmarking
methodology provides for a population of assigned beneficiaries during
the benchmark years that is comparable to the population assigned
during the performance years. We also note, in the future, when an ACO
renews for a new agreement period and its previous performance years
become historical benchmark years, beneficiaries who were voluntarily
aligned to the ACO for those years will then be included in the
historical benchmark calculations for the ACO's new agreement period.
Comment: One commenter stated the current voluntary alignment
process can be confusing and causes unnecessary delays in assigning
beneficiaries to the ACO in which their primary clinician participates.
The commenter suggested a rolling voluntary alignment process allowing
beneficiaries who voluntarily align with an ACO to be added to the
assignment list for that ACO during a performance year.
Response: We understand that our policy of performing beneficiary
assignment annually can cause a delay between when a beneficiary
selects their primary clinician and when the beneficiary is assigned to
the ACO. However, we believe this approach reduces complexity and
burden. For example, ACOs are able to clearly identify a date by which
to communicate to their beneficiaries regarding the opportunity to
designate a primary clinician if they would like to align with an ACO
professional.
Comment: One commenter expressed concern that physicians with a
specialty designation not used in assignment would become subject to
the exclusivity requirements, which would limit an ACO participant to
participation in a single ACO. The commenter opposed any policy that
would require an ACO participant to be exclusive to a single Shared
Savings Program ACO in the event that a beneficiary voluntarily aligns
to a practitioner billing under the TIN of that ACO participant.
Response: We agree with the concerns raised by the commenter and
believe it is important to clarify the operational process we will
implement if a beneficiary designates a clinician billing under the TIN
of an ACO participant that participates in more than one Shared Savings
Program ACO (as permitted under certain circumstances under Sec.
425.306(b)) as their primary clinician. ACO participants that do not
bill for services that are considered in assignment will not be
required to be

[[Page 59964]]

exclusive to a single Shared Savings Program ACO as a result of the
changes to the voluntary alignment methodology. In the circumstance
where a beneficiary aligns with a clinician billing under an ACO
participant TIN that is participating in more than one Shared Savings
Program ACO, we will determine where the beneficiary received the
plurality of their primary care services under our claims-based
assignment methodology under Sec. 425.402(b). If the beneficiary did
not receive the plurality of their primary care services from ACO
professionals in either ACO, we will not assign the beneficiary to
either of the ACOs. However, consistent with Sec. 425.402(c)(2)(iv),
we will honor the beneficiary's selection of a primary clinician and
will not align the beneficiary to another ACO in which their primary
clinician is not participating.
We did not receive any public comments on the proposal not to
voluntarily align a beneficiary to the ACO in which their primary
clinician participates when the beneficiary is also eligible for
assignment to an entity participating in a model tested or expanded
under section 1115A of the Act under which claims-based assignment is
based solely on claims for services other than primary care services
(for example, CEC).
After considering the comments received in response to the
proposals to revise the voluntary alignment methodology, we are
finalizing the policies as proposed. Specifically, we are finalizing
the policy to assign a beneficiary to an ACO based upon their selection
of any ACO professional, regardless of specialty, as their primary
clinician. We are also finalizing our proposal to remove the
requirement that a beneficiary must have received at least one primary
care service from an ACO professional who is either a primary care
physician or a physician with a specialty designation included in Sec.
425.402(c) within the 12-month assignment window in order to be
assigned to the ACO. Lastly, we are finalizing a policy not to
voluntarily align a beneficiary to an ACO when the beneficiary is also
eligible for assignment to an entity participating in a model tested or
expanded under section 1115A of the Act under which claims-based
assignment is based solely on claims for services other than primary
care services. Accordingly, we are also finalizing the proposed
revisions to Sec. 425.402(e)(2) without modification.
c. Revisions to the Definition of Primary Care Services Used in
Beneficiary Assignment
(1) Background
Section 1899(c)(1) of the Act, as amended by the 21st Century Cures
Act and the Bipartisan Budget Act of 2018, provides that for
performance years beginning on or after January 1, 2019, the Secretary
shall assign beneficiaries to an ACO based on their utilization of
primary care services provided by a physician and all services
furnished by RHCs and FQHCs. However, the statute does not specify
which kinds of services may be considered primary care services for
purposes of beneficiary assignment. We established the initial list of
services that we considered to be primary care services in the November
2011 final rule (76 FR 67853). In that final rule, we indicated that we
intended to monitor this issue and would consider making changes to the
definition of primary care services to add or delete codes used to
identify primary care services, if there were sufficient evidence that
revisions were warranted. We have updated the list of primary care
service codes in subsequent rulemaking to reflect additions or
modifications to the codes that have been recognized for payment under
the Medicare PFS, as summarized in the CY 2018 PFS proposed rule (82 FR
34109 and 34110). Subsequently, in the CY 2018 PFS final rule, we
revised the definition of primary care services to include three
additional chronic care management service codes, 99487, 99489, and
G0506, and four behavioral health integration service codes, G0502,
G0503, G0504 and G0507 (82 FR 53212 and 53213). These additions are
effective for purposes of performing beneficiary assignment under Sec.
425.402 for performance year 2019 and subsequent performance years.
Accounting for these recent changes, we define primary care
services in Sec. 425.400(c) for purposes of assigning beneficiaries to
ACOs under Sec. 425.402 as the set of services identified by the
following HCPCS/CPT codes:
CPT codes:
(1) 99201 through 99215 (codes for office or other outpatient visit
for the evaluation and management of a patient).
(2) 99304 through 99318 (codes for professional services furnished
in a Nursing Facility, excluding services furnished in a SNF which are
reported on claims with place of service code 31).
(3) 99319 through 99340 (codes for patient domiciliary, rest home,
or custodial care visit).
(4) 99341 through 99350 (codes for evaluation and management
services furnished in a patients' home).
(5) 99487, 99489 and 99490 (codes for chronic care management).
(6) 99495 and 99496 (codes for transitional care management
services).
HCPCS codes:
(1) G0402 (the code for the Welcome to Medicare visit).
(2) G0438 and G0439 (codes for the Annual Wellness Visits).
(3) G0463 (code for services furnished in electing teaching
amendment hospitals).
(4) G0506 (code for chronic care management).
(5) G0502, G0503, G0504 and G0507 (codes for behavioral health
integration).
As discussed in the CY 2018 PFS final rule (82 FR 53213), a
commenter recommended that CMS consider including the advance care
planning codes, CPT codes 99497 and 99498, in the definition of primary
care services in future rulemaking. We indicated that we would consider
whether CPT codes 99497 and 99498 or any additional existing HCPCS/CPT
codes should be added to the definition of primary care services in
future rulemaking for purposes of assignment of beneficiaries to ACOs
under the Shared Savings Program. In addition, effective for CY 2018,
the HCPCS codes for behavioral health integration G0502, G0503, G0504
and G0507 have been replaced by CPT codes 99492, 99493, 99494, 99484
(82 FR 53078).
CPT codes 99304 through 99318 are used for reporting evaluation and
management (E&M) services furnished by physicians and other
practitioners in a SNF (reported on claims with POS code 31) or a
nursing facility (reported on claims with POS code 32). Based on
stakeholder input, we finalized a policy in the CY 2016 PFS final rule
(80 FR 71271 through 71272) effective for performance year 2017 and
subsequent performance years, to exclude services identified by CPT
codes 99304 through 99318 from the definition of primary care services
for purposes of the beneficiary assignment methodology when the claim
includes the POS code 31 modifier designating the services as having
been furnished in a SNF. We established this policy to recognize that
SNF patients are shorter stay patients who are generally receiving
continued acute medical care and rehabilitative services. Although
their care may be coordinated during their time in the SNF, they are
then transitioned back into the community to the primary care
professionals who are typically responsible for providing care to meet
their true primary care needs. We

[[Page 59965]]

continue to believe that it is appropriate for SNF patients to be
assigned to ACOs based on care received from primary care professionals
in the community (including nursing facilities), who are typically
responsible for providing care to meet the true primary care needs of
these beneficiaries. As we discussed in the August 2019 proposed rule
(83 FR 41897), ACOs serving special needs populations, including
beneficiaries receiving long term care services, and other stakeholders
have recently suggested that we consider an alternative method for
determining operationally whether services identified by CPT codes
99304 through 99318 were furnished in a SNF. Instead of indirectly
determining whether a beneficiary was a SNF patient when the services
were furnished based on physician claims data, these stakeholders
suggest we more directly determine whether a beneficiary was a SNF
patient based on SNF facility claims data. These commenters recommended
that CMS use contemporaneous SNF Medicare facility claims to determine
whether a professional service identified by CPT codes 99304 through
99318 was furnished in a SNF, and therefore, should not be used for
purposes of the beneficiary assignment methodology under Sec. 425.402.
Specifically, these commenters suggested that we determine whether
services identified by CPT codes 99304 through 99318 were furnished in
a SNF by determining whether the beneficiary also received SNF facility
services on the same date of service.
In the August 2018 proposed rule (83 FR 41897 through 41899), we
proposed to make changes to the definition of primary care services in
Sec. 425.400(c) to add new codes and to revise how we determine
whether services identified by CPT codes 99304 through 99318 were
furnished in a SNF.
(2) Proposed Revisions
Based on feedback from ACOs and our further review of the HCPCS and
CPT codes currently recognized for payment under the PFS, we believe it
would be appropriate to amend the definition of primary care services
to include certain additional codes. Specifically, we proposed to
revise the definition of primary care services in Sec. 425.400(c) to
include the following HCPCS and CPT codes: (1) Advance care planning
service codes; CPT codes 99497 and 99498; (2) administration of health
risk assessment service codes; CPT codes 96160 and 96161; (3) prolonged
evaluation and management or psychotherapy service(s) beyond the
typical service time of the primary procedure, CPT codes 99354 and
99355; (4) annual depression screening service code, HCPCS code G0444;
(5) alcohol misuse screening service code, HCPCS code G0442; and (6)
alcohol misuse counseling service code, HCPCS code G0443. In addition,
in the CY 2019 PFS proposed rule (see 83 FR 35841 through 35844), CMS
proposed to create three new HCPCS codes to reflect the additional
resources involved in furnishing certain evaluation and management
services: (1) GPC1X add-on code, for the visit complexity inherent to
evaluation and management associated with certain primary care
services, (2) GCG0X add-on code, for visit complexity inherent to
evaluation and management associated with endocrinology, rheumatology,
hematology/oncology, urology, neurology, obstetrics/gynecology,
allergy/immunology, otolaryngology, or interventional pain management-
centered care, and (3) GPRO1, an additional add-on code for prolonged
evaluation and management or psychotherapy services beyond the typical
service time of the primary procedure. As we explained in the August
2018 proposed rule (83 FR 41897), we believe it would be appropriate to
include these codes in the definition of primary care services under
the Shared Savings Program because these codes are used to bill for
services that are similar to services that are already included in the
list of primary care codes at Sec. 425.400(c). We also expect that
primary care physicians, nurse practitioners, physician assistants, and
clinical nurse specialists frequently furnish these services as part of
their overall management of a patient. As a result, we believe that
including these codes would increase the accuracy of the assignment
process by helping to ensure that beneficiaries are assigned to the ACO
or other entity that is actually managing the beneficiary's care.
The following provides additional information about the HCPCS and
CPT codes that we proposed to add to the definition of primary care
services:
Advance care planning (CPT codes 99497 and 99498):
Effective January 1, 2016, CMS pays for voluntary advance care planning
under the PFS (80 FR 70955 through 70959). See CMS, Medicare Learning
Network, ``Advance Care Planning'' (ICN 909289, August 2016), available
at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/AdvanceCarePlanning.pdf. Advance care
planning enables Medicare beneficiaries to make important decisions
that give them control over the type of care they receive and when they
receive it. Medicare pays for advance care planning either as a
separate Part B service when it is medically necessary or as an
optional element of a beneficiary's Annual Wellness Visit. We believe
it would be appropriate to include both Advance Care Planning codes
99497 and 99498 in the definition of primary care services under the
Shared Savings Program because the services provided as part of advance
care planning include counseling and other evaluation and management
services similar to the services included in Annual Wellness Visits and
other evaluation and management service codes that are already included
in the list of primary care codes.
Administration of health risk assessment (CPT codes 96160
and 96161): In the CY 2017 PFS final rule (81 FR 80330 through 80331),
we added two new CPT codes, 96160 and 96161, to the PFS, effective for
CY 2017, to be used for payment for the administration of health risk
assessment. These codes are ``add-on codes'' that describe additional
resource components of a broader service furnished to the patient that
are not accounted for in the valuation of the base code. For example,
if a health risk assessment service were administered during a
physician office visit, then the physician would bill for both the
appropriate office visit code and the appropriate health risk
assessment code. We believe it would be appropriate to include CPT
codes 96160 and 96161 in the definition of primary care services
because these add-on codes frequently represent additional practice
expenses related to office visits for evaluation and management
services that are already included in the definition of primary care
services.
Prolonged evaluation and management or psychotherapy
service(s) beyond the typical service time of the primary procedure
(CPT codes 99354 and 99355): These two codes are also ``add-on codes''
that describe additional resource components of a broader service
furnished in the office or other outpatient setting that are not
accounted for in the valuation of the base codes. Code 99354 is listed
on a claim to report the first hour of additional face-to-face time
with a patient and code 99355 is listed separately for each additional
30 minutes of face-to-face time with a patient beyond the time reported
under code 99354. Codes 99354 and 99355 would be billed separately in
addition to the base office or other outpatient evaluation and
management or

[[Page 59966]]

psychotherapy service. (See Medicare Claims Processing Manual Chapter
12, Sections 30.6.15.1 Prolonged Services With Direct Face-to-Face
Patient Contact Service (Codes 99354-99357) available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c12.pdf; also see CMS, MLN Matters, Prolonged Services (Codes
99354-99359) (Article Number MM5972, Revised March 7, 2017), available
at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/mm5972.pdf.) Although we do
not currently include prolonged services codes CPT codes 99354 and
99355 on our list of primary care services, based on further review we
believe it would be appropriate to include them on our list of primary
care services to more accurately assign beneficiaries to ACOs based on
all the allowed charges for the primary care services furnished to
beneficiaries. In the August 2018 proposed rule (83 FR 41898), we noted
that the definitions of codes 99354 and 99355 also include prolonged
services for certain psychotherapy services, which are not currently
included on our list of primary care services. Therefore, we proposed
to include the allowed charges for CPT codes 99354 and 99355, for
purposes of assigning beneficiaries to ACOs, only when the base code is
also on the list of primary care services.
Annual depression screening (HCPCS code G0444), alcohol
misuse screening (HCPCS code G0442), and alcohol misuse counseling
(HCPCS code G0443): Effective October 14, 2011, all Medicare
beneficiaries are eligible for annual depression screening and alcohol
misuse screening. (See CMS Manual System, Screening for Depression in
Adults (Transmittal 2359, November 23, 2011) available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/R2359CP.pdf; and see CMS, MLN Matters, Screening and Behavioral
Counseling Interventions in Primary Care to Reduce Alcohol Misuse
(Article Number MM7633, Revised June 4, 2012), available at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/mm7633.pdf). Although these three codes
have been in use since before the implementation of the Shared Savings
Program in 2012, based on further review of these services, we believe
that it would be appropriate to consider these services in beneficiary
assignment. Annual depression screening may be covered if it is
furnished in a primary care setting that has staff-assisted depression
care supports in place to assure accurate diagnosis, effective
treatment, and follow-up. Alcohol misuse screening and counseling are
screening and behavioral counseling interventions in primary care to
reduce alcohol misuse. All three of these codes include screening and
counseling services similar to counseling and other evaluation and
management services included in the codes already on the list of
primary care codes.
In the CY 2019 PFS proposed rule (see 83 FR 35841 through 35844),
we proposed to create three new HCPCS G-codes as part of a broader
proposal to simplify the documentation requirements and to more
accurately pay for services represented by CPT codes 99201 through
99215 (codes for office or other outpatient visit for the evaluation
and management of a patient). All three of these codes are ``add-on
codes'' that describe additional resource components of a broader
service furnished to the patient that are not accounted for in the
valuation of the base codes.
HCPCS code GPC1X is intended to capture the additional resource
costs, beyond those involved in the base evaluation and management
codes, of providing face-to-face primary care services for established
patients. HCPCS code GPC1X would be billed in addition to the base
evaluation and management code for an established patient when the
visit includes primary care services. In contrast, new HCPCS code GCG0X
is an add-on code intended to reflect the complexity inherent to
evaluation and management services associated with endocrinology,
rheumatology, hematology/oncology, urology, neurology, obstetrics/
gynecology, allergy/immunology, otolaryngology, cardiology, and
interventional pain management-centered care. As we stated in the
August 2018 proposed rule (83 FR 41899), we believe it would be
appropriate to include both proposed new HCPCS codes GCG0X and GPC1X in
our definition of primary care services because they represent services
that are currently included in CPT codes 99201 through 99215, which are
already included in the list of primary care codes in Sec. 425.400(c).
Finally, proposed new HCPCS code GPRO1 (prolonged evaluation and
management or psychotherapy services beyond the typical service time of
the primary procedure, in the office or other outpatient setting
requiring direct patient contact beyond the usual service; 30 minutes)
is modeled on CPT code 99354, a prolonged services code discussed
earlier in this section which we proposed to add to our list of primary
care services. HCPCS code GPRO1 is intended to reflect prolonged
evaluation and management or psychotherapy service(s) of 30 minutes
duration beyond the typical service time of the primary or base
service, whereas existing CPT code 99354 reflects prolonged services of
60 minutes duration. As is the case for code 99354, code GPRO1 would be
billed separately in addition to the base office or other outpatient
evaluation and management or psychotherapy service. We stated that we
believe it would be appropriate to include proposed HCPCS code GPRO1 on
our list of primary care services for the same reasons we proposed to
add CPT code 99354 to our list of primary care services. Because the
proposed definition of HCPCS code GPRO1 also includes prolonged
services for certain psychotherapy services, which are not currently
included on our list of primary care services, we proposed to include
the allowed charges for HCPCS code GPRO1, for purposes of assigning
beneficiaries to ACOs, only when the base code is also on the list of
primary care services.
We proposed to include these codes in the definition of primary
care services when performing beneficiary assignment under Sec.
425.402, for performance years starting on January 1, 2019, and
subsequent years. However, we noted that our proposal to include the
three proposed new ``add-on codes'', GPC1X, GCG0X, and GPRO1, was
contingent on CMS finalizing its proposal to create these new codes for
use starting in 2019.
As discussed in section V.B.2.c.(1) of this final rule, ACOs and
other commenters have expressed concerns regarding our current policy
of identifying services billed under CPT codes 99304 through 99318
furnished in a SNF by using the POS modifier 31. We continue to believe
it is appropriate to exclude from assignment services billed under CPT
codes 99304 through 99318 when such services are furnished in a SNF.
However, as we explained in the August 2018 proposed rule (83 FR
41899), we agree with commenters that it might increase the accuracy of
beneficiary assignment for these vulnerable and generally high cost
beneficiaries if we were to revise our method for determining whether
services identified by CPT codes 99304 through 99318 were furnished in
a SNF to focus on whether the beneficiary also received SNF facility
services on the same day. We believe it would be feasible for us to
directly and more precisely determine whether services identified by
CPT codes 99304 through

[[Page 59967]]

99318 were furnished in a SNF by analyzing our facility claims data
files rather than by using the POS modifier 31 in our professional
claims data files. Operationally, we would exclude professional
services claims billed under CPT codes 99304 through 99318 from use in
the assignment methodology when there is a SNF facility claim in our
claims files with dates of service that overlap with the date of
service for the professional service. Therefore, we proposed to revise
the regulation at Sec. 425.400(c)(1)(iv)(A)(2), effective for
performance years starting on January 1, 2019 and subsequent
performance years, to remove the exclusion of claims including the POS
code 31 and in its place to indicate more generally that we will
exclude services billed under CPT codes 99304 through 99318 when such
services are furnished in a SNF.
Under our current process, if CMS' HCPCS committee or the American
Medical Association's CPT Editorial Panel modifies or replaces any of
the codes that we designate as primary care service codes in Sec.
425.400(c), we must revise the primary care service codes listed in
Sec. 425.400(c) as appropriate through further rulemaking before the
revised codes can be used for purposes of assignment. As noted
previously, effective for CY 2018, the HCPCS codes for behavioral
health integration G0502, G0503, G0504 and G0507 have been replaced by
CPT codes 99492, 99493, 99494 and 99484. Therefore, consistent with our
current process, we proposed to revise the primary care service codes
in Sec. 425.400(c)(1)(iv) to replace HCPCS codes G0502, G0503, G0504
and G0507 with CPT codes 99492, 99493, 99494 and 99484 for performance
years starting on January 1, 2019, and subsequent performance years.
We also noted that the regulations text at Sec. 425.400(c)(1)(iv)
includes brief descriptions for the HCPCS codes that we have designated
as primary care service codes, but does not include such descriptions
for the CPT codes that we have designated as primary care service
codes. For consistency, we proposed a technical change to the
regulations at Sec. 425.400(c)(1)(iv)(A) to also include descriptions
for the CPT codes. We also noted that one of the Chronic Care
Management (CCM) codes, CPT code 99490, is inadvertently listed in the
regulations text at Sec. 425.400(c)(1)(iv)(A)(6) along with the codes
for Transitional Care Management (TCM) services. We proposed a
technical change to the regulations to move CPT code 99490 up to Sec.
425.400(c)(1)(iv)(A)(5) with the other CCM codes.
We welcomed comments on the new codes we proposed to add to the
definition of primary care services used for purposes of assigning
beneficiaries to Shared Savings Program ACOs. In addition, we sought
comment on our proposal to revise our method for excluding services
identified by CPT codes 99304 through 99318 when furnished in a SNF. We
also sought comment on the other proposed technical changes to Sec.
425.400(c)(1)(iv). We also welcomed comments on any additional existing
HCPCS/CPT codes that we should consider adding to the definition of
primary care services in future rulemaking.
Comment: Some commenters supported the proposed changes to the
definition of primary care services. One commenter suggested we include
the Initial Preventive Physician Examination, or Welcome to Medicare
Visit, as well as the annual wellness visit CPT codes in the
definition.
Response: We appreciate the commenters' support for the proposed
amendments to the definition of primary care services. We also note we
currently include the Welcome to Medicare (G0402) and annual wellness
visit (G0438 and G0439) CPT codes in the definition of primary care
services under Sec. 425.400(c).
Comment: Many commenters supported the proposal to modify Sec.
425.400(c)(1)(iv)(A)(2) to remove the exclusion of claims including the
POS code 31 and in its place indicate more generally that we will
exclude services billed under CPT codes 99304 through 99318 from use in
the assignment methodology when such services are furnished in a SNF,
as determined based on whether there is a SNF facility claim with dates
of service that overlap with the date of service for the professional
service. One commenter supported this proposal because they noted it
would better identify beneficiaries who have received short-term care
and appropriately exclude them from assignment.
Response: We appreciate the commenters' support for the proposal to
modify Sec. 425.400(c)(1)(iv)(A)(2) to remove the exclusion of claims
including the POS code 31 modifier and in its place to exclude services
billed under CPT codes 99304 through 99318 when such services are
furnished in a SNF. We are finalizing the policy as proposed.
Comment: Concerning the proposal to remove the exclusion of claims
including the POS code 31, one commenter suggested we use a longer
claims run-out period to account for the institutional billing
practices for SNFs. This commenter also stated they would ``welcome
transparency related to POS 31 and 32 claims-based attribution'' in the
claim and claims line feed files we provide to participating ACOs under
Sec. 425.704.
Response: As we noted in the 2011 Shared Savings Program final rule
(76 FR 67837), a 3-month claims run-out results in a completion
percentage of approximately 98.5 percent for physician services and 98
percent for Part A services. Additionally, the claim and claim line
feed files furnished to ACOs under Sec. 425.704 contain Parts A and B
claims data regarding beneficiaries who are either prospectively
assigned to the ACO or who may be assigned to the ACO at the end of the
performance year, depending on the assignment methodology under which
the ACO participates. As long as the beneficiary has not declined to
share their claims data, and the claim does not include protected
health information related to substance use disorder treatment, ACOs
receive both the claims for physician services and the facility level
claims that would be used to determine whether a service billed under
CPT codes 99304 through 99318 was furnished in a SNF.
Comment: A few commenters suggested we only include the newly
proposed CPT/HCPCS codes under step 1 of the two-step assignment
methodology. The commenters stated these codes should be used for
``assigning beneficiaries on the basis of care furnished specifically
by primary care physicians and not all ACO professionals.''
Response: We disagree with these comments. We continue to believe
our current assignment methodology generally provides an appropriate
balance between maintaining a strong emphasis on primary care while
ultimately allowing for assignment of beneficiaries on the basis of how
they actually receive their primary care services (80 FR 32748). We
also note that the list of specialty types included in step 1 and step
2 of the assignment methodology was informed by CMS medical officers
knowledgeable about the services typically performed by physicians and
non-physician practitioners (80 FR 32750) as well as comments received
in response to the 2014 Shared Savings Program proposed rule.
Comment: One commenter suggested an alternative assignment
methodology that the commenter believed would be similar to a
methodology discussed in the CY 2019 PFS proposed rule which would
distinguish between primary and secondary specialties for practitioners

[[Page 59968]]

billing under the same TIN as part of a multispecialty group. The
commenter stated this approach would improve the accuracy of the
assignment methodology by focusing on evaluation and management
services furnished by primary care providers, rather than specialists.
Alternatively, this commenter suggested an assignment methodology
similar to methodologies used by state agencies. According to the
commenter, this assignment methodology would allow for exclusions,
attribution, and tie-breaking steps to support a valid beneficiary
population.
Response: We encourage the commenter to review our assignment
methodology under the Shared Savings Program regulations at 42 CFR part
425, subpart E. Our current assignment methodology emphasizes primary
care services provided by primary care clinicians in step one, before
considering primary care services furnished by certain specialists in
step two. However, we will continue to monitor this issue to determine
whether there have been any changes or refinements that would allow us
to more precisely identify both primary and secondary practitioner
specialties in Medicare claims data and whether those changes should be
accounted for in the assignment methodology used in the Shared Savings
Program. Any changes to our assignment methodology would be proposed
through future rulemaking for the Shared Savings Program.
As discussed earlier in this final rule, the proposal to create
three new HCPCS G-codes as part of a broader proposal to simplify the
documentation requirements and to more accurately pay for the office or
other outpatient evaluation and management services represented by CPT
codes 99201 through 99215 is not being finalized. Therefore, the
proposal to include HCPCS ``add-on codes'', GPC1X, GCG0X, and GPRO1 in
the definition of ``primary care services'' will not be finalized at
this time. We will revisit this proposal in future rulemaking and
continue to monitor the annual rulemaking for the PFS to determine if
we should propose any changes to the definition of primary care
services for the Shared Savings Program to reflect proposed HCPCS/CPT
coding changes.
We received no comments on the proposed technical changes to Sec.
425.400(c)(1)(iv). After considering the comments received, we are
finalizing our proposed revisions to the definition of primary care
services, with the exception of the proposal to include the three add-
on HCPCS codes GPC1X, GCG0X, and GPRO1. Specifically, we are revising
the definition of primary care services in Sec. 425.400(c) to add CPT
codes 99497, 99498, 96160, 96161, 99354, and 99355, and HCPCS codes
G0444, G0442, and G0443. Additionally, we are finalizing, as proposed,
the revisions to our method for excluding services identified by CPT
codes 99304 through 99318 when furnished in a SNF and the proposed
technical changes to Sec. 425.400(c)(1)(iv).
Consistent with the approach we have taken in the past when
implementing changes to the assignment methodology, we will adjust
ACOs' historical benchmarks for the performance year starting on
January 1, 2019, to account for the changes to the assignment
methodology that we are finalizing in this final rule.
d. Extreme and Uncontrollable Circumstances Policies for the Shared
Savings Program
(1) Background
Following the 2017 California wildfires and Hurricanes Harvey,
Irma, Maria, and Nate, stakeholders expressed concerns that the effects
of these types of disasters on ACO participants, ACO providers/
suppliers, and the assigned beneficiary population could undermine an
ACO's ability to successfully meet the quality performance standards,
and adversely affect financial performance, including, in the case of
ACOs under performance-based risk, increasing shared losses. To address
these concerns, we published an interim final rule with comment period
titled Medicare Program; Medicare Shared Savings Program: Extreme and
Uncontrollable Circumstances Policies for Performance Year 2017
(hereinafter referred to as the Shared Savings Program IFC) that
appeared in the December 26, 2017 Federal Register (82 FR 60912). In
the Shared Savings Program IFC, we established policies for addressing
ACO quality performance scoring and the determination of the shared
losses owed by ACOs participating under performance-based risk tracks
for ACOs that were affected by extreme or uncontrollable circumstances
during performance year 2017. The policies adopted in the Shared
Savings Program IFC were effective for performance year 2017, including
the applicable quality data reporting period for the performance year.
We have considered the comments received on the Shared Savings Program
IFC in developing the policies for 2018 and subsequent years.
The extreme and uncontrollable circumstances policies established
in the Shared Savings Program for performance year 2017 align with the
policies established under the Quality Payment Program for the 2017
MIPS performance period and subsequent MIPS performance periods (see CY
2018 Quality Payment Program final rule with comment, 82 FR 53780
through 53783 and Quality Payment Program IFC, 82 FR 53895 through
53900). In particular, in the Shared Savings Program IFC (82 FR 60914),
we indicated that we would determine whether an ACO had been affected
by an extreme and uncontrollable circumstance by determining whether 20
percent or more of the ACO's assigned beneficiaries resided in counties
designated as an emergency declared area in performance year 2017 as
determined under the Quality Payment Program or the ACO's legal entity
was located in such an area. In the Quality Payment Program IFC (82 FR
53897), we explained that we anticipated that the types of events that
could trigger the extreme and uncontrollable circumstances policies
would be events designated a Federal Emergency Management Agency (FEMA)
major disaster or a public health emergency declared by the Secretary,
although we indicated that we would review each situation on a case-by-
case basis.
Because ACOs may face extreme and uncontrollable circumstances in
2018 and subsequent years, we proposed to extend the policies adopted
in the Shared Savings Program IFC for addressing ACO quality
performance scoring and the determination of the shared losses owed for
ACOs affected by extreme or uncontrollable circumstances to performance
year 2018 and subsequent performance years. In addition, in the Shared
Savings Program IFC, we indicated that we planned to observe the impact
of the 2017 hurricanes and wildfires on ACOs' expenditures for their
assigned beneficiaries during performance year 2017, and might revisit
the need to make adjustments to the methodology for calculating the
benchmark in future rulemaking. We considered this issue further in the
August 2018 proposed rule (see 83 FR 41904 through 41906).
(2) Proposed Revisions
The financial and quality performance of ACOs located in areas
subject to extreme and uncontrollable circumstances could be
significantly and adversely affected. Disasters may have several
possible effects on ACO quality and financial performance. For
instance, displacement of beneficiaries may make it difficult for ACOs
to access medical record data required for quality

[[Page 59969]]

reporting, as well as, reduce the beneficiary response rate on survey
measures. Further, for practices damaged by a disaster, the medical
records needed for quality reporting may be inaccessible. We also
believe that disasters may affect the infrastructure of ACO
participants, ACO providers/suppliers, and potentially the ACO legal
entity itself, thereby disrupting routine operations related to their
participation in the Shared Savings Program and achievement of program
goals. The effects of a disaster could include challenges in
communication between the ACO and its participating providers and
suppliers and in implementation of and participation in programmatic
activities. Catastrophic events outside the ACO's control can also
increase the difficulty of coordinating care for patient populations,
and due to the unpredictability of changes in utilization and cost of
services furnished to beneficiaries, may have a significant impact on
expenditures for the applicable performance year and the ACO's
benchmark in the subsequent agreement period. These factors could
jeopardize ACOs' ability to succeed in the Shared Savings Program, and
ACOs, especially those in performance-based risk tracks, may reconsider
whether they are able to continue their participation in the program.
As we stated in the August 2018 proposed rule (83 FR 41900),
because widespread disruptions could occur during 2018 or subsequent
performance years, we believe it is appropriate to have policies in
place to change the way in which we assess the quality and financial
performance of Shared Savings Program ACOs in any affected areas.
Accordingly, we proposed to extend the automatic extreme and
uncontrollable circumstances policies under the Shared Savings Program
that were established for performance year 2017 to performance year
2018 and subsequent performance years. Specifically, we proposed that
the Shared Savings Program extreme and uncontrollable circumstances
policies for performance year 2018 and subsequent performance years
would apply when we determine that an event qualifies as an automatic
triggering event under the Quality Payment Program. As we discussed in
the Shared Savings Program IFC (82 FR 60914), we believe it is also
appropriate to extend these policies to encompass the quality reporting
period, unless the reporting period is extended, because if an ACO is
unable to submit its quality data as a result of a disaster occurring
during the quality data submission window, we would not have the
quality data necessary to measure the ACO's quality performance for the
performance year. For example, if an extreme and uncontrollable event
were to occur in February 2019, which we anticipate would be during the
quality data reporting period for performance year 2018, then the
extreme and uncontrollable circumstances policies would apply for
quality data reporting and quality performance scoring for performance
year 2018, if the reporting period is not extended. We explained that
we do not believe it is appropriate to extend this policy to encompass
the quality data reporting period if the reporting period is extended
because affected ACOs would have an additional opportunity to submit
their quality data, enabling us to measure their quality performance in
the applicable performance year. Accordingly, we also proposed that the
policies regarding quality reporting would apply with respect to the
determination of the ACO's quality performance in the event that an
extreme and uncontrollable event occurs during the applicable quality
data reporting period for a performance year and the reporting period
is not extended. However, we noted that, because a disaster that occurs
after the end of the performance year would have no impact on the
determination of an ACO's financial performance for that performance
year, it would not be appropriate to make an adjustment to shared
losses in the event an extreme or uncontrollable event occurs during
the quality data reporting period.
Comment: Commenters overwhelmingly supported adopting permanent
policies to mitigate the impacts of extreme and uncontrollable
circumstances. Several commenters supported finalizing the proposals
without modification; however, the majority of commenters suggested
modifications to the proposed policies or requested that CMS adopt
additional means of providing relief to disaster affected ACOs. The
comments and recommendations are discussed below in sections
V.B.2.d.(1), (2), and (3) of this final rule.
Response: We appreciate commenters' support for adopting permanent
policies to provide relief to ACOs that are affected by extreme and
uncontrollable circumstances.
Comment: A few commenters recommended that CMS take into
consideration whether an ACO has experienced an extreme and
uncontrollable event during its agreement period when applying certain
policies proposed in other sections of the August 2018 proposed rule,
if finalized. These included proposed policies related to monitoring
for financial performance, repayment mechanism amounts, reconciliation
after termination and the determination of participant Medicare FFS
revenue and prior participation for purposes of determining
participation options.
Response: We thank commenters for their suggestions on ways to
further limit the potential negative impacts of extreme and
uncontrollable circumstances on ACOs affected by such events. We
believe that these suggestions fall outside the scope of the proposals
described in section II.E.4 of the August 2018 proposed rule that we
are addressing in this final rule. We anticipate discussing our
proposals related to other sections of the August 2018 proposed rule in
a forthcoming final rule and will address comments related to those
sections at that time.
(a) Modification of Quality Performance Scores for All ACOs in Affected
Areas
As we explained in the Shared Savings Program IFC (82 FR 60914
through 60916), ACOs and their ACO participants and ACO providers/
suppliers are frequently located across several different geographic
regions or localities, serving a mix of beneficiaries who may be
differentially impacted by hurricanes, wildfires, or other triggering
events. Therefore, for 2017, we established a policy for determining
when an ACO, which may have ACO participants and ACO providers/
suppliers located in multiple geographic areas, would qualify for the
automatic extreme and uncontrollable circumstance policies for the
determination of quality performance. Specifically, we adopted a policy
for performance year 2017 of determining whether an ACO had been
affected by extreme and uncontrollable circumstances by determining
whether 20 percent or more of the ACO's assigned beneficiaries resided
in counties designated as an emergency declared area in the performance
year, as determined under the Quality Payment Program as discussed in
the Quality Payment Program IFC (82 FR 53898) or the ACO's legal entity
was located in such an area. For 2017, we adopted a policy under which
the location of an ACO's legal entity was determined based on the
address on file for the ACO in CMS' ACO application and management
system. We used 20 percent of the ACO's assigned beneficiary population
as the minimum threshold to establish an ACO's eligibility for the
policies regarding quality reporting and quality

[[Page 59970]]

performance scoring for 2017 because, as we stated in the Shared
Savings Program IFC, we believe the 20 percent threshold provides a
reasonable way to identify ACOs whose quality performance may have been
adversely affected by an extreme or uncontrollable circumstance, while
excluding ACOs whose performance would not likely be significantly
affected.
The 20 percent threshold was selected to account for the effect of
an extreme or uncontrollable circumstance on an ACO that has the
minimum number of assigned beneficiaries to be eligible for the program
(5,000 beneficiaries), and in consideration of the average total number
of unique beneficiaries for whom quality information is required to be
reported in the combined CAHPS survey sample (860 beneficiaries) and
the CMS Web Interface sample (approximately 3,500 beneficiaries).
(There may be some overlap between the CAHPS sample and the CMS Web
Interface sample.) Therefore, we estimated that an ACO with an assigned
population of 5,000 beneficiaries typically would be required to report
quality information on a total of 4,000 beneficiaries. Thus, we
indicated that we believe the 20 percent threshold ensures that an ACO
with the minimum number of assigned beneficiaries would have an
adequate number of beneficiaries across the CAHPS and CMS Web Interface
samples in order to fully report on these measures. However, we also
noted that it is possible that some ACOs that have fewer than 20
percent of their assigned beneficiaries residing in affected areas may
have a legal entity that is located in an emergency declared area.
Consequently, their ability to quality report may be equally impacted
because the ACO legal entity may be unable to collect the necessary
information from their ACO participants or may experience
infrastructure issues related to capturing, organizing, and reporting
the data to CMS. We stated that if less than 20 percent of the ACO's
assigned beneficiaries reside in an affected area and the ACO's legal
entity is not located in a county designated as an affected area, then
we believe that there is unlikely to be a significant impact upon the
ACO's ability to report or on the representativeness of the quality
performance score that is determined for the ACO. For performance year
2017, we determined what percentage of the ACO's performance year
assigned population was affected by a disaster based on the final list
of beneficiaries assigned to the ACO for the performance year. Although
beneficiaries are assigned to ACOs under Track 1 and Track 2 based on
preliminary prospective assignment with retrospective reconciliation
after the end of the performance year, these ACOs were able to use
their quarterly assignment lists, which include beneficiaries' counties
of residence, for early insight into whether they were likely to meet
the 20 percent threshold.
In the Shared Savings Program IFC, we modified the quality
performance standard specified under Sec. 425.502 by adding a new
paragraph (f) to address potential adjustments to the quality
performance scores for performance year 2017 of ACOs determined to be
affected by extreme and uncontrollable circumstances. We also modified
Sec. 425.502(e)(4) to specify that an ACO receiving the mean Shared
Savings Program ACO quality score for performance year 2017 based on
the extreme and uncontrollable circumstances policies would not be
eligible for bonus points awarded based on quality improvement in that
year because quality data would not be available to determine if there
was improvement from year to year.
In the Shared Savings Program IFC, we established policies with
respect to quality reporting and quality performance scoring for the
2017 performance year. In anticipation of any future extreme and
uncontrollable events, in the August 2018 proposed rule (83 FR 41901)
we proposed to extend these policies, with minor modifications, to
subsequent performance years as well. In order to avoid confusion and
reduce unnecessary burdens on affected ACOs, we proposed to align our
policies for 2018 and subsequent years with policies established for
the Quality Payment Program in the final rule with comment period,
entitled CY 2018 Updates to the Quality Payment Program (82 FR 53568).
Specifically, we proposed to apply determinations made under the
Quality Payment Program with respect to whether an extreme and
uncontrollable circumstance has occurred and the identification of the
affected geographic areas and the applicable time periods. Generally,
in line with the approach taken for 2017 in the Quality Payment Program
IFC (82 FR 53897), we anticipated that the types of events that would
be considered an automatic triggering event would be events designated
as a Federal Emergency Management Agency (FEMA) major disaster or a
public health emergency declared by the Secretary, but indicated that
CMS would review each situation on a case-by-case basis. We also
proposed that CMS would have sole discretion to determine the time
period during which an extreme and uncontrollable circumstance
occurred, the percentage of the ACO's assigned beneficiaries residing
in the affected areas, and the location of the ACO legal entity.
Additionally, we proposed to determine an ACO's legal entity location
based on the address on file for the ACO in CMS' ACO application and
management system.
In the Shared Savings Program IFC, we established a policy for
performance year 2017 under which we determined the percentage of the
ACO's assigned population that was affected by a disaster based on the
final list of beneficiaries assigned to the ACO for the performance
year. We begin producing the final list of assigned beneficiaries after
allowing for 3 months of claims run out following the end of a
performance year. However, the quality reporting period ends before the
3-month claims run out period ends. Therefore, in the August 2018
proposed rule we expressed concern that if, for future performance
years, we continue to calculate the percentage of affected
beneficiaries based on the ACO's final list of assigned beneficiaries,
it would not be operationally feasible for us to notify an ACO as to
whether it meets the 20 percent threshold prior to the end of the
quality reporting period because the final list of assigned
beneficiaries is not available until after the close of the quality
reporting period. We explained that we now believe it would be
appropriate to base this calculation on the list of assigned
beneficiaries used to generate the Web Interface quality reporting
sample, which would be available with the quarter three program
reports, generally in November of the applicable performance year. We
also indicated this report would be available to ACOs participating in
the proposed 6-month performance year from January 1, 2019 through June
30, 2019. By basing the calculation on the list of assigned
beneficiaries used to generate the Web Interface quality reporting
sample, we would be able to notify ACOs earlier as to whether they
exceed the 20 percent threshold, and ACOs could then use this
information to decide whether to report quality data for the
performance year. Therefore, for performance year 2018 and subsequent
performance years, we proposed to determine the percentage of an ACO's
assigned beneficiaries that reside in an area affected by an extreme
and uncontrollable circumstance using the list of assigned
beneficiaries used to generate the Web Interface quality reporting
sample. We indicated that we

[[Page 59971]]

could use this assignment list report regardless of the date(s) the
natural disaster occurred. The assignment list report provides us with
a list of beneficiaries who have received the plurality of their
primary care services from ACO professionals in the ACO at a specific
point in time. As this is the list that is used to determine the
quality reporting sample, we believe it is appropriate to use the same
list to determine how many of the ACO's beneficiaries reside in an area
affected by a disaster, such that the ACO's ability to report quality
data could be compromised. We proposed to revise Sec. 425.502(f) to
reflect this proposal for performance year 2018 and subsequent years.
In the Shared Savings Program IFC (82 FR 60916), we described the
policies under the MIPS APM scoring standard that would apply for
performance year 2017 for MIPS eligible clinicians in an ACO that did
not completely report quality. The existing tracks of the Shared
Savings Program (Track 1, Track 2 and Track 3), and the Track 1+ Model
are all MIPS APMs under the APM scoring standard.\35\ If finalized, we
expect the BASIC track and ENHANCED track (based on Track 3) proposed
in the August 2018 proposed rule would similarly be considered MIPS
APMs under the APM scoring standard. In the August 2018 proposed rule
(83 FR 41902), we noted, for purposes of the APM scoring standard, MIPS
eligible clinicians in an ACO that has been affected by an extreme and
uncontrollable circumstance and does not report quality for a
performance year, and therefore, receives the mean ACO quality score
under the Shared Savings Program, would have the MIPS quality
performance category reweighted to zero percent resulting in MIPS
performance category weighting of 75 percent for the Promoting
Interoperability performance category and 25 percent for the
Improvement Activities performance category under the APM scoring
standard per our policy at Sec. 414.1370(h)(5)(i)(B). In the event an
ACO that has been affected by an extreme and uncontrollable
circumstance is able to completely and accurately report all quality
measures for a performance year, and therefore receives the higher of
the ACO's quality performance score or the mean quality performance
score under the Shared Savings Program, we would not reweight the MIPS
quality performance category to zero percent under the APM scoring
standard. Additionally, unless otherwise excepted, the ACO participants
will receive a Promoting Interoperability (PI) (formerly called
Advancing Care Information (ACI)) performance category score under the
APM scoring standard based on their reporting, which could further
increase their final score under MIPS.
---------------------------------------------------------------------------

\35\ See, for example Alternative Payment Models in the Quality
Payment Program as of February 2018, available at https://www.cms.gov/Medicare/Quality-Payment-Program/Resource-Library/Comprehensive-List-of-APMs.pdf.
---------------------------------------------------------------------------

We proposed to revise Sec. 425.502(f) to extend the policies
established for performance year 2017 to performance year 2018 and
subsequent performance years. Specifically, we proposed that for
performance year 2018 and subsequent performance years, including the
applicable quality data reporting period for the performance year if
the reporting period is not extended, in the event that we determine
that 20 percent or more of an ACO's assigned beneficiaries, as
determined using the list of beneficiaries used to generate the Web
Interface quality reporting sample, reside in an area that is affected
by an extreme and uncontrollable circumstance, as determined under the
Quality Payment Program, or that the ACO's legal entity is located in
such an area, we would use the following approach to calculate the
ACO's quality performance score as specified in proposed revisions to
paragraphs (e) and (f) of Sec. 425.502.
The ACO's minimum quality score would be set to equal the
mean quality performance score for all Shared Savings Program ACOs for
the applicable performance year.
If the ACO is able to completely and accurately report all
quality measures, we would use the higher of the ACO's quality
performance score or the mean quality performance score for all Shared
Savings Program ACOs. If the ACO's quality performance score is used,
the ACO would also be eligible for quality improvement points.
If the ACO receives the mean Shared Savings Program
quality performance score, the ACO would not be eligible for bonus
points awarded based on quality improvement during the applicable
performance year.
If an ACO receives the mean Shared Savings Program ACO
quality performance score for a performance year, in the next
performance year for which the ACO reports quality data and receives a
quality performance score based on its own performance, we would
measure quality improvement based on a comparison between the ACO's
performance in that year and in the most recently available prior
performance year in which the ACO reported quality. Under this
approach, the comparison would continue to be between consecutive years
of quality reporting, but these years may not be consecutive calendar
years.
Additionally, we proposed to address the possibility that ACOs that
have a 6-month performance year (or performance period) during 2019 may
be affected by extreme and uncontrollable circumstances. In this final
rule, we are addressing the proposals specific to the 6-month
performance year from January 1, 2019 through June 30, 2019. In a
forthcoming final rule, we anticipate discussing comments received on
the proposals related to policies for the 6-month performance year from
July 1, 2019 through December 31, 2019, and the performance period from
January 1, 2019 through June 30, 2019, for ACOs that terminate their
agreement effective June 30, 2019, and enter a new agreement period
starting on July 1, 2019. We anticipate this discussion will include a
description of the applicability of policies for addressing extreme and
uncontrollable circumstances.
As described in section II.A.7 of the August 2018 proposed rule, we
proposed to use 12 months of data, based on the calendar year, to
determine quality performance for the 6-month performance year from
January 2019 through June 2019 (83 FR 41856 through 41858). We
explained our belief that it is necessary to account for disasters
occurring in any month(s) of CY 2019 for ACOs participating in a 6-
month performance year during 2019 regardless of whether the ACO is
actively participating in the Shared Savings Program at the time of the
disaster. Therefore, for ACOs with a 6-month performance year from
January 1, 2019 through June 30, 2019, affected by a disaster in any
month of 2019, we would use the alternative scoring methodology
specified in Sec. 425.502(f) to determine the quality performance
score for the 2019 quality reporting period, if the reporting period is
not extended. For example, assume that an ACO participates in the
Shared Savings Program for a 6-month performance year from January 1,
2019 through June 30, 2019, and does not continue its participation in
the program for a new agreement period beginning July 1, 2019 (as
proposed). Further assume that we determine that 20 percent or more of
the ACO's assigned beneficiaries, as determined using the list of
beneficiaries used to generate the Web Interface quality reporting
sample, reside in an area that is affected by an extreme and
uncontrollable circumstance, as determined under the

[[Page 59972]]

Quality Payment Program, in September 2019. The ACO's quality
performance score for the 2019 reporting period would be adjusted
according to the policies in Sec. 425.502(f).
We proposed to specify the applicability of the alternative scoring
methodology in Sec. 425.502(f) for the 6-month performance year from
January 1, 2019 through June 30, 2019, in the proposed new section of
the regulations at Sec. 425.609(d).
We solicited comments on the proposed policies for assessing the
quality performance of ACOs affected by an extreme or uncontrollable
circumstance during performance year 2018 and subsequent years,
including the applicable quality data reporting period for the
performance year, unless the reporting period is extended.
Comment: One commenter incorrectly stated that CMS proposed to
continue to use a threshold of 25 percent to determine the
applicability of the proposed alternative quality scoring policies
(rather than the actual 20 percent proposed) and noted that they agreed
that this threshold was reasonable. This commenter also suggested that
CMS consider other percentage thresholds, such as 5 percent or 10
percent, as test cases. The same commenter also encouraged CMS to look
at the percentage of an ACO's physicians and other health clinicians
located in an impacted area as another means of determining which ACOs
should be automatically eligible for the alternative quality scoring
policy. This commenter suggested, for example, using a threshold of 50
percent of NPIs located in an impacted area, based on the practice
locations listed in the Provider Enrollment, Chain, and Ownership
System (PECOS).
Response: We are finalizing our proposal to continue to use 20
percent of assigned beneficiaries residing in a disaster-affected as
one of the criteria for determining whether an ACO is eligible for the
alternative quality scoring methodology. We will continue to monitor
this criterion as we gain more experience with these policies. However,
at present we believe that the 20 percent threshold, which was
influenced by considerations related to ensuring a sufficient
population size to allow affected ACOs to fully report on quality,
remains a reasonable level. While we considered the commenter's
suggestion to expand the criteria for identifying affected ACOs to
include ACOs for which 50 percent or more of the NPIs billing under the
ACO participant TINs are located in an impacted area, we believe that
including this additional criterion would create additional operational
complexity and less transparency as we do not currently include
information on the location of ACO providers/suppliers in program
reports.
Comment: Several commenters stated that the proposed policy of
using the higher of an ACO's own quality score in the affected year or
the national mean score unfairly penalizes ACOs that have had
historically high quality performance. One commenter also noted that
this approach could unfairly reward ACOs with historically low quality
performance to the detriment of the Medicare Trust Funds. These
commenters recommended that CMS should adopt an approach that considers
an ACO's own quality score from one or more prior years, if available.
Some of the commenters explained this approach would be similar to a
policy used in Medicare Advantage.
Commenters offered various suggestions on how to implement a policy
that considers an ACO's historic quality performance. A few commenters
recommended that CMS use the highest of the ACO's quality score for the
affected performance year, the ACO's quality score for the prior
performance year (if available), or the national mean quality score.
One commenter recommended following this approach for each individual
quality measure. Suggestions from other commenters included: Using the
higher of the ACO's average quality score for the prior two years and
the national mean for ACOs in their third or subsequent year in the
program and using the national average score for ACOs in their first or
second year in the program; Using the higher of the affected year
quality score and the prior year quality score, if one is available,
and otherwise using the higher of the affected year score and the
national mean score; Using the ACO's historical quality performance
instead of the mean when an ACO is in its third or subsequent
performance year in the program.
Several commenters also recommended that the proposed policies in
this section be extended to include all ACOs affected by a natural
disaster, not just those that cannot report quality data. A few
commenters provided suggestive evidence that quality outcome measures
such as readmission measures may be subject to immediate and
significant impacts in the event of a natural disaster, which could
have an adverse impact on an ACO's quality score, particularly given
the non-linear nature of the program's quality scoring methodology
under which an ACO receives zero points on a measure if it falls below
the 30th percentile. Several commenters requested that that those ACOs
whose scores on readmissions measures (ACO-8, all-cause readmissions
and ACO-35, SNF readmissions) fall below the 30th percentile should be
eligible to have their quality score adjusted to account for the
natural disaster.
Response: We acknowledge that for some ACOs, the mean quality score
could be lower, or higher, than the score those ACOs would have
received in the absence of a disaster. However, we have concerns with
the recommended alternatives which would potentially apply an ACO's
score from the prior year or apply a score that is an average of prior
year scores, particularly for ACOs in their early years of
participation in the Shared Savings Program and for which the prior
years may have included a higher number of pay-for-reporting measures,
thus making the quality scores incomparable. Likewise, in section
III.F.1.b. of this final rule we are finalizing several quality
measures for use beginning in performance year 2019. These measures
will be pay-for-reporting for the first 2 years of use (2019 and 2020).
All else being equal, the addition of these new pay-for-reporting
measures will increase ACOs' quality scores. Also, we note that ACO
quality performance can vary from year to year and the fact that an ACO
had a high quality score in prior years does not necessarily guarantee
that the ACO would have had an above average score in the affected year
in the absence of the natural disaster. Lastly, we would remind
commenters that the national mean quality score includes the quality
scores of 100 percent earned by ACOs in their first performance year,
thus increasing the mean.
For these reasons, we are declining at this time to adopt
commenters' recommendations that we consider prior year quality scores
as part of determining the quality performance scores of ACOs affected
by extreme and uncontrollable circumstances and are finalizing the
proposed policy. We are also declining to adopt the commenter's
recommendation to give special consideration to ACOs based on their
performance on the ACO-8 and ACO-35 readmissions measures. We would
also like to clarify that both the policy that we finalized for
performance year 2017 in the Shared Savings Program IFC and the policy
we are finalizing in this rule for performance year 2018 and subsequent
performance years would apply to all ACOs deemed to be affected by an
extreme and uncontrollable circumstance (20 percent or more of assigned
beneficiaries residing in an

[[Page 59973]]

affected area or legal entity located in such an area), including those
ACOs that were able to report quality and those for which scores on
ACO-8 and ACO-35 fell below the 30th percentile. We will continue to
monitor quality performance among ACOs affected by extreme and
uncontrollable circumstances, and as we gain more experience will
consider whether any changes to the finalized policy are warranted.
Comment: One commenter agreed with setting a disaster-affected
ACO's quality score to the national mean but opposed using the mean
score to calculate ``future benchmarks or subsequent year thresholds
until complete and accurate reporting can be achieved.'' They noted
that ``setting quality benchmarks to an artificial mean is not a valid
approach to determine legitimate savings and losses.''
Response: We clarify that ACOs' quality performance scores are not
used to calculate quality measure benchmarks. Rather, the quality
measure benchmarks are calculating using actual ACO performance and all
other available and applicable Medicare FFS data.
Comment: One commenter recommended that all affected ACOs should
receive the higher of the 2018 or 2019 Star Rating for each CAHPS
measure.
Response: We note that the Shared Savings Program does not provide
a Star Rating to ACOs based on their CAHPS performance. Star Ratings
are used for Medicare Advantage and Medicare Prescription Drug plans to
provide quality and performance information to Medicare beneficiaries
to assist them in choosing their health and drug services and, solely
for Medicare Advantage plans, to implement the quality bonus payment
adopted by Congress in the Patient Protection and Affordable Care Act.
We believe that incorporating Star Ratings into the Shared Savings
Program would need to be part of a larger effort that was not
contemplated in the August 2018 proposed rule. In contrast, we believe
our proposal of using the higher of an ACO's own calculated quality
score or the mean quality score serves as a way to mitigate negative
impacts for disaster-affected ACOs in manner that can be readily
incorporated into the existing structure of the Shared Savings Program
quality scoring methodology.
Comment: A few commenters recommended that CMS remove claims
associated with disaster-impacted beneficiaries and time periods or
claims with disaster payment modifier codes when calculating the
numerator and denominator of the readmissions measures and other
claims-based quality measures.
Response: As we describe in section V.B.2.b. of this final rule, we
have examined the use of existing disaster payment modifiers during
2017 and have found their utilization to be low overall and to vary
across ACOs, including those with comparably high shares of
beneficiaries residing in disaster affected areas. Therefore, we have
concerns that these codes would not serve as a useful means for
comprehensively identifying relevant claims. We also have concerns
about removing claims for beneficiaries residing in affected areas
during affected time periods. In addition to adding considerable
complexity, this approach could lead to the elimination of a large
number of claims for some ACOs. This could lead to bias if the claims
removed are systematically different from other claims for reasons
apart from the natural disaster, such as because they are concentrated
in a specific geographic area or time period and may also make it more
difficult for CMS to provide an oversample of beneficiaries to ACOs for
the CMS Web Interface sample.
Comment: One commenter requested that CMS provide additional
clarity before finalizing any of the policies for extreme and
uncontrollable circumstances proposed in the August 2018 proposed rule.
In particular, the commenter requested that CMS provide additional
clarification on how the agency would determine and announce whether
the extreme and uncontrollable circumstances policies would apply or if
the reporting period would be extended.
Response: We intend to make an initial determination about whether
an ACO meets the criteria for being considered a disaster-affected ACO
after quarter 3 assignment has been determined and before the start of
the quality reporting period. We will make the final determination with
respect to affected ACOs after the end of the calendar year in order to
capture any additional extreme and uncontrollable circumstances that
may occur in the remainder of the year or during the quality reporting
period, if not extended. We will continue to use the quarter 3
assignment list as the basis for this final determination. In the event
that CMS decides to extend the quality reporting period, we would
provide notification to ACOs through existing communication channels
such as the Shared Savings Program newsletter or an email blast. We
also note that if an ACO is determined to be an affected ACO as a
result of an extreme or uncontrollable circumstance during the
performance year, the alternative quality scoring methodology would
apply, regardless of whether the quality reporting period is extended.
Comment: One commenter recommended that CMS adopt the same period
as any Declaration of Emergency by the Secretary when determining the
applicable time period for an extreme and uncontrollable circumstance
instead of an alternative period selected by CMS that may not be as
well-aligned with the reality of health services instability for areas
under a declaration of emergency. Another commenter encouraged CMS to
be transparent regarding the criteria used to determine the applicable
time period and to work closely with Medicare Administrative
Contractors and the Federal Emergency Management Agency to communicate
these policies to ACOs.
Response: We are finalizing our proposals for extreme and
uncontrollable circumstances, including our proposal that CMS will have
the sole discretion to determine the time period during which an
extreme and uncontrollable circumstance occurred. Although we are not
adopting fixed criteria for determining the applicable time periods, we
note that for performance year 2017 we used the time periods associated
with public health emergencies declared by the Secretary and listed on
the CMS Emergency Response and Recovery website (now renamed the
Emergency Preparedness & Response Operations website at https://www.cms.gov/About-CMS/Agency-Information/Emergency/EPRO/EPRO-Home.html). We anticipate continuing this practice, which we believe to
be transparent, going forward. Furthermore, for events for which the
public health emergency declaration spans calendar years, we intend to
treat the portion of the period falling within each year as if it were
a separate event for purposes of identifying ACOs eligible for the
alternative quality scoring methodology and for computing any
adjustment to shared losses.
Comment: One commenter expressed concerns about what they described
as CMS' ``one-size-fits-all'' approach for determining the time period
during which an ACO would be subject to the extreme and uncontrollable
circumstances policies. They encouraged CMS to allow ACOs an
opportunity to request relief from shared losses and negative quality
adjustments over a longer period of time, up to a full performance
year, to be evaluated by CMS on a case-by-case basis. The commenter
noted that the impact of a disaster occurring early in the year may
have a different impact

[[Page 59974]]

than one occurring later in the year and there may be long-lasting
effects, which should not have counted against affected ACOs. They
stated that the hardship exemption, which would be approved by CMS on a
case-by-case basis, would have limited effect on the Trust Funds, but
would be important for the integrity of the program by establishing a
formal process for ACOs to request an exemption based on extenuating
circumstances.
Response: We have elected to adopt automatic policies to address
extreme and uncontrollable circumstances in lieu of hardship requests
that must be considered on a case-by-case basis in order to increase
certainty and reduce administrative burden for both ACOs and CMS. We
will continue to monitor the impact of the policies that we are
finalizing in this rule, and as we gain more experience, if warranted,
we will propose additional modifications through future notice and
comment rulemaking.
After considering the comments received, we are finalizing our
proposals to extend the policies for determining the quality scores for
ACOs affected by extreme and uncontrollable circumstances established
for performance year 2017 to performance year 2018 and subsequent
performance years. Specifically, we are revising Sec. Sec. 425.502(e)
and 425.502(f) to state that for performance year 2018 and subsequent
performance years, including the applicable quality data reporting
period for the performance year, if the reporting period is not
extended, in the event that we determine that 20 percent or more of an
ACO's assigned beneficiaries, as determined using the list of assigned
beneficiaries used to generate the Web Interface quality reporting
sample, reside in an area that is affected by an extreme and
uncontrollable circumstance, as determined under the Quality Payment
Program, or that the ACO's legal entity is located in such an area, we
will use the following approach to calculate the ACO's quality
performance score:
The ACO's minimum quality score will be set to equal the
mean quality performance score for all Shared Savings Program ACOs for
the applicable performance year.
If the ACO is able to completely and accurately report all
quality measures, we will use the higher of the ACO's quality
performance score or the mean quality performance score for all Shared
Savings Program ACOs. If the ACO's quality performance score is used,
the ACO will also be eligible for quality improvement points.
If the ACO receives the mean Shared Savings Program
quality performance score, the ACO will not be eligible for bonus
points awarded based on quality improvement during the applicable
performance year.
If an ACO receives the mean Shared Savings Program ACO
quality performance score for a performance year, in the next
performance year for which the ACO reports quality data and receives a
quality performance score based on its own performance, we will measure
quality improvement based on a comparison between the ACO's performance
in that year and in the most recently available prior performance year
in which the ACO reported quality.
We clarify that if an ACO reports quality data in a year in which
it is affected by an extreme and uncontrollable circumstance, but
receives the national mean quality score, we will use the ACO's own
quality performance score to determine quality improvement bonus points
in the following year. For example, if an ACO reported quality data in
years 1, 2, and 3 of an agreement period, but received the national
mean quality score in year 2 as the result of an extreme or
uncontrollable circumstance, we would determine quality improvement
bonus points for year 3 by comparing the ACO's year 3 quality score
with its year 2 score. If the ACO received the mean score in year 2
because it did not report quality, we would compare year 3 with year 1
to determine the bonus points for year 3.
We also want to clarify one point regarding the interaction between
this alternative quality scoring methodology and MIPS. As we noted
above, the MIPS quality performance category is reweighted to zero if a
disaster-affected ACO receives the mean quality score under the Shared
Savings Program's extreme and uncontrollable circumstance policy,
because it did not or could not report quality data at the ACO (APM
Entity) level, regardless of whether or not any of the ACOs participant
TINs reported quality outside the ACO. This reweighting under MIPS
results in MIPS performance category weighting of 75 percent for the PI
performance category and 25 percent for IA performance category. If,
for any reason, the PI performance category also is reweighted to zero,
which could be more likely when there is a disaster, there would be
only one performance category triggering the policy under which the ACO
in question would receive a neutral (threshold) MIPS score, as per
Sec. 414.1380(c) (see discussion at 83 FR 53778). If any of the ACO's
participant TINs do report PI, then the TIN or TINs' PI performance
category scores will be used to score the ACO under the MIPS scoring
standard, the PI performance category will not be reweighted, and the
policy to assign a neutral (threshold) MIPS score will not be
triggered.
(b) Mitigating Shared Losses for ACOs Participating in a Performance-
Based Risk Track
In the Shared Savings Program IFC (82 FR 60916) we modified the
payment methodology for performance year 2017 for performance-based
risk tracks established under the authority of section 1899(i) of the
Act, to mitigate shared losses owed by ACOs affected by extreme and
uncontrollable circumstances during 2017. Under this approach, we
reduced the ACO's shared losses, if any, determined to be owed for
performance year 2017 under the existing methodology for calculating
shared losses in the Shared Savings Program regulations at 42 CFR part
425 subpart G by an amount determined by multiplying the shared losses
by two factors: (1) The percentage of the total months in the
performance year affected by an extreme and uncontrollable
circumstance; and (2) the percentage of the ACO's assigned
beneficiaries who resided in an area affected by an extreme and
uncontrollable circumstance. For performance year 2017, we determined
the percentage of the ACO's performance year assigned beneficiary
population that was affected by the disaster based on the final list of
beneficiaries assigned to the ACO for the performance year. For
example, assume that an ACO was determined to owe shared losses of
$100,000 for performance year 2017, a disaster was declared for October
through December during the performance year, and 25 percent of the
ACO's assigned beneficiaries resided in the disaster area. In this
scenario, we would have adjusted the ACO's shared losses in the
following manner: $100,000-($100,000 x 0.25 x 0.25) = $100,000-$6,250 =
$93,750. The policies for performance year 2017 are specified in
paragraph (i) in Sec. 425.606 for ACOs under Track 2 and Sec. 425.610
for ACOs under Track 3.
In the August 2018 proposed rule (83 FR 41903), we stated our
belief that it would be appropriate to continue to apply these policies
in performance year 2018 and subsequent years to address stakeholders'
concerns that ACOs participating under a performance-based risk track
could be held responsible for sharing losses with the Medicare program
resulting from catastrophic events outside the ACO's control given

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the increase in utilization, difficulty of coordinating care for
patient populations leaving the impacted areas, and the use of natural
disaster payment modifiers making it difficult to identify whether a
claim would otherwise have been denied under normal Medicare FFS rules.
Absent this relief, we believe that ACOs participating in performance-
based risk tracks might reconsider whether they are able to continue
their participation in the Shared Savings Program under a performance-
based risk track. The approach we adopted for performance year 2017 in
the Shared Savings Program IFC, and which we proposed to continue for
performance year 2018 and subsequent years, balances the need to offer
relief to affected ACOs with the need to continue to hold those ACOs
accountable for losses incurred during the months in which there was no
applicable disaster declaration and for the portion of their final
assigned beneficiary population that was outside the area affected by
the disaster. In the August 2018 proposed rule, we explained our belief
that, consistent with the policy adopted for performance year 2017 in
the Shared Savings Program IFC, it would be appropriate to continue to
use the final assignment list report for the performance year for
purposes of this calculation. This final assignment list report would
be available at the time we conduct final reconciliation and provides
the most complete information regarding the extent to which an ACO's
assigned beneficiary population was affected by a disaster.
Additionally, we proposed to also address the possibility that ACOs
that have a 6-month performance year during 2019 may be affected by
extreme and uncontrollable circumstances. In this final rule, we are
addressing the proposals specific to the 6-month performance year from
January 1, 2019 through June 30, 2019. In a forthcoming final rule, we
anticipate discussing comments received on the proposals related to
policies for the 6-month performance year from July 1, 2019 through
December 31, 2019, and the performance period from January 1, 2019
through June 30, 2019 for ACOs that terminate their agreement effective
June 30, 2019, and enter a new agreement period starting on July 1,
2019. We anticipate this discussion will include a description of the
applicability of policies for determining shared losses for ACOs
affected by extreme and uncontrollable circumstances.
As described in section II.A.7. of the August 2018 proposed rule
(83 FR 41849 through 41853) and the proposed provision at Sec.
425.609, we proposed to use 12 months of expenditure data, based on the
calendar year, to perform financial reconciliation for the 6-month
performance year from January 1, 2019 through June 30, 2019.
Accordingly, for ACOs participating in a 6-month performance year
during the first half of 2019, we believed it would be necessary to
account for disasters occurring in any month(s) of CY 2019, regardless
of whether the ACO is actively participating in the Shared Savings
Program at the time of the disaster.
For ACOs with a 6-month performance year that are affected by an
extreme or uncontrollable circumstance during CY 2019, we proposed to
first determine shared losses for the ACO over the full calendar year,
adjust the shared losses for extreme and uncontrollable circumstances,
and then determine the portion of shared losses for the 6-month
performance year according to the methodology proposed under Sec.
425.609. For example, assume that: A disaster was declared for October
2019 through December 2019; an ACO is being reconciled for its
participation during the performance year from January 1, 2019 through
June 30, 2019; the ACO is determined to have shared losses of $100,000
for CY 2019; and 25 percent of the ACO's assigned beneficiaries reside
in the disaster area. In this scenario, we would adjust the ACO's
losses in the following manner: $100,000-($100,000 x 0.25 x 0.25) =
$100,000-$6,250 = $93,750, then we would multiply these losses by the
portion of the year the ACO participated = $93,750 x 0.5 = $46,875.
Therefore, we proposed to amend Sec. Sec. 425.606(i) and
425.610(i) to extend the policies regarding extreme and uncontrollable
circumstances that were established for performance year 2017 to
performance year 2018 and subsequent years. In addition, we proposed to
include a provision at Sec. 425.609(d) to provide that the policies on
extreme and uncontrollable circumstances would apply to the
determination of shared losses for ACOs participating in a 6-month
performance year during 2019.
In the August 2018 proposed rule (83 FR 41904), we noted that to
the extent that our proposal to extend the policies adopted in the
Shared Savings Program IFC to 2018 and subsequent performance years
constitutes a proposal to change the payment methodology for 2018 after
the start of the performance year, we believe that consistent with
section 1871(e)(1)(A)(ii) of the Act, and for the reasons discussed in
section II.E.4 of the August 2018 proposed rule (83 FR 41899 through
41906), it would be contrary to the public interest not to propose to
establish a policy under which we would have the authority to adjust
the shared losses calculated for ACOs in Track 2 and Track 3 for
performance year 2018 to reflect the impact of any extreme or
uncontrollable circumstances that may occur during the year.
We also explained that these proposed policies would not change the
status of those payment models that meet the criteria to be Advanced
APMs under the Quality Payment Program (see Sec. 414.1415). Our
proposed policies would reduce the amount of shared losses owed by ACOs
affected by a disaster, but the overall financial risk under the
payment model would not change and participating ACOs would still
remain at risk for an amount of shared losses in excess of the Advanced
APM generally applicable nominal amount standard. Additionally, these
policies would not prevent an eligible clinician from satisfying the
requirements to become a QP for purposes of the APM Incentive Payment
(available for payment years through 2024) or higher physician fee
schedule updates (for payment years beginning in 2026) under the
Quality Payment Program.
We also emphasized that all ACOs would continue to be entitled to
share in any savings they may achieve for a performance year. ACOs in
all tracks of the program will continue to receive shared savings
payments, if any, as determined under subpart G of the regulations. The
calculation of savings and the determination of shared savings payment
amounts for a performance year would not be affected by the proposed
policies to address extreme and uncontrollable circumstances, except
that the quality performance score for an affected ACO may be adjusted
as described in section II.E.4 of the proposed rule.
We solicited comments on the proposed policies for assessing the
financial performance of ACOs affected by an extreme or uncontrollable
circumstance during performance year 2018 and subsequent years.
Comment: Several commenters noted that ACOs are likely to
experience increased expenditures as the result of a natural disaster.
One commenter noted that studies have shown that natural disasters
materially increase Medicare costs per beneficiary. A few other
commenters noted that costs can increase because of the impact of the
disaster on beneficiaries' health, safety and anxiety causing increased
utilization of services but also because waivers effected during
declared Public

[[Page 59976]]

Health Emergencies relax Medicare payment rules allowing more services
to be covered than usual. Another commenter stated that an ACO may
experience expenditure increases because its assigned beneficiaries
migrate to areas with higher FFS payment rates in search of health care
services in the wake of a natural disaster. This commenter noted that
ACOs based in Puerto Rico could be significantly affected given that
after a natural disaster many beneficiaries migrate to the U.S.
mainland where the FFS payment rates are substantially higher than on
the island.
Several commenters shared the opinion that the proposed policy of
adjusting shared losses adequately addresses the situation of ACOs that
would have had shared losses in the absence of a natural disaster, but
had higher shared losses as the result of the disaster. However, they
expressed concern that the policy does not provide relief to ACOs that
receive a smaller shared savings payment as a result of the disaster or
ACOs for which an expenditure increase resulting from a disaster causes
the ACO to fall short of its MSR (and thus miss out on shared savings
entirely) or to exceed its MLR (and thus owe shared losses when it
otherwise would not have had shared losses).
A few commenters recommended addressing this issue by modifying the
update that is applied to an ACO's benchmark for a performance year
that is affected by an extreme and uncontrollable circumstance. For
example, these commenters recommended that CMS apply a growth rate that
is the higher of the national growth rate for assignable beneficiaries
or the regional growth rate for assignable beneficiaries (excluding an
ACO's own assigned beneficiaries). They suggested that their
recommendation should be used instead of the ``current policy'' for
accounting for the impact of disasters on performance year
expenditures, which they believed relies on the use of natural disaster
payment modifiers. A few other commenters recommended that CMS use a
blend of national and regional expenditure growth rates to update the
benchmark as proposed in the August 2018 rule in ``normal times'' but
use a purely regional growth rate in the event of an extreme and
uncontrollable circumstance. The same commenters also suggested that
CMS remove claims associated with disaster-affected beneficiaries
during the relevant time periods or claims with a natural disaster
payment modifier code, pending changes to improve these codes, when
calculating performance or benchmark year expenditures. It was unclear,
however, whether they meant for these claims adjustments to be made
instead of or in addition to their recommended changes to the update
factors applied to the historical benchmark.
Several commenters raised concerns about the existing natural
disaster modifier codes and whether, in their current form, they could
be used to try to capture the negative impact on an ACO's performance.
They noted that some health care providers may not be aware of the
existence of such codes and that the codes may not be used properly due
to lack of training and competing priorities during an emergency event.
They also noted that the existing codes do not capture instances of
``unsafe place of discharge'', which they believe is a common reason
for lengths of stay to be increased during a disaster and recommended
that CMS expand existing modifier codes or add a new code to cover this
circumstance. A few commenters recommended providing proper education
on the use of such codes, which would allow these codes to serve as a
more accurate means for identifying the impacts of natural disasters.
Another commenter recommended that CMS allow an additional 6 to 12
months for providers to submit such codes to be considered in
expenditure calculations.
Response: We are finalizing our proposed approach to mitigate
shared losses for ACOs affected by extreme and uncontrollable
circumstances without modification in this final rule. We acknowledge
commenters' concerns regarding the potential impact of extreme and
uncontrollable circumstances on the financial performance of ACOs that
do not owe shared losses and we appreciate the commenters'
recommendations for how to mitigate these impacts. However, because we
did not propose to make any adjustments under these circumstances,
these recommendations are outside the scope of this rulemaking. We will
continue to monitor the financial performance of ACOs affected by
extreme and uncontrollable circumstances, and as we gain more
experience will consider whether any changes to our policies for
mitigating the effects of extreme and uncontrollable circumstances are
warranted.
Furthermore, we note that although we considered the use of natural
disaster payment modifiers in developing the original extreme and
uncontrollable circumstances policy for performance year 2017, we did
not adopt a policy that used such codes in the Shared Savings Program
IFC, nor did we propose in the August 2018 proposed rule to use such
codes to adjust benchmark or performance year expenditure calculations
for performance year 2018 or subsequent years. We have examined the
existing natural disaster payment modifiers (specifically the ``DR''
condition code used on institutional claims and the ``CR'' modifier
code used on Part B institutional and non-institutional claims) in 2017
claims for ACO assigned beneficiaries. We found that these codes were
not widely or consistently used and that there appears to be variation
in their use among ACOs. For example, among 69 ACOs with 90 percent or
more of assigned beneficiaries residing in a disaster affected area, we
found that only 0.01 percent of institutional claims and only 0.0006
percent of non-institutional claims included such a code. Among this
same group of ACOs, the total number of claims (institutional or non-
institutional) containing one of these codes ranged from 0 to 155 with
a mean of 14 and a median of 8. In a separate analysis, we found that
claims completion rates were comparable in disaster-affected and non-
affected years which suggests that the low levels of modifier usage are
not necessarily due to delayed claim submission. Based on these
analyses, as well as the comments offered in response to the August
2018 proposed rule, we also have concerns that these codes would not
serve as a useful means for comprehensively identifying relevant
claims.
As we described in the August 2018 proposed rule, and have
recounted in this final rule, we have some concerns about removing
claims for affected beneficiaries and time periods from benchmark year
expenditure calculations. As we develop additional experience, we may
revisit this policy and, if warranted, propose modifications to
performance or benchmark year expenditure calculations for ACOs
affected by extreme and uncontrollable circumstances through further
notice and comment rulemaking.
We also note that, although the policies regarding extreme and
uncontrollable circumstances we are finalizing in this final rule do
not include an explicit adjustment to the shared savings payment of a
disaster-affected ACO, our alternative methodology for quality scoring
can indirectly increase an ACO's shared savings payment. In performance
year 2017, 62 of 117 disaster-affected ACOs received the national mean
quality score, as it was higher than the score the

[[Page 59977]]

ACO would have received in the absence of the policy.
After considering the comments received, we are finalizing our
proposal to extend the policy for mitigating shared losses owed by ACOs
affected by extreme and uncontrollable circumstances established for
performance year 2017 to performance year 2018 and subsequent
performance years. We are revising Sec. Sec. 425.606(i) and 425.610(i)
to indicate that we will reduce the amount of shared losses calculated
for the performance year by an amount determined by multiplying (1) the
percentage of the total months in the performance year affected by an
extreme and uncontrollable circumstance; and (2) the percentage of the
ACO's assigned beneficiaries who reside in an area affected by an
extreme and uncontrollable circumstance. We are also finalizing our
proposal, through a new provision at Sec. 425.609(d), to adjust shared
losses for ACOs with a 6-month performance year from January 1, 2019
through June 30, 2019. For ACOs in a 6-month performance year we will
first determine shared losses for the ACO over the full calendar year,
reduce the ACO's shared losses for the calendar year for extreme and
uncontrollable circumstances, and then determine the portion of shared
losses for the 6-month performance year.
(c) Determination of Historical Benchmarks for ACOs in Affected Areas
In the Shared Savings Program IFC, we sought comment on how to
address the impact of extreme and uncontrollable circumstances on the
expenditures for an ACO's assigned beneficiary population for purposes
of determining the benchmark (82 FR 60917). As we explained in the
Shared Savings Program IFC (82 FR 60913), the impact of disasters on an
ACO's financial performance could be unpredictable as a result of
changes in utilization and cost of services furnished to the Medicare
beneficiaries it serves. In some cases, ACO participants might be
unable to coordinate care because of migration of patient populations
leaving the impacted areas. On the other hand, patient populations
remaining in impacted areas might receive fewer services and have lower
overall costs to the extent that healthcare providers are unable to
reopen their offices because they lack power and water or have limited
access to fuel for operating alternate power generators. Significant
changes in costs incurred, whether increased or decreased, as a result
of an extreme or uncontrollable circumstance may impact the benchmark
determined for the ACO's subsequent agreement period in the Shared
Savings Program, as performance years of the current agreement period
become the historical benchmark years for the subsequent agreement
period. An increase in expenditures for a particular calendar year
would result in a higher benchmark value when the same calendar year is
used to determine the ACO's historical benchmark, and in calculating
adjustments to the rebased benchmark based on regional FFS
expenditures. Likewise, a decrease in expenditures for a particular
calendar year would result in a lower benchmark value when the same
calendar year is used to determine the ACO's historical benchmark.
While considering options for adjusting ACOs' historical benchmarks
to account for disasters occurring during a benchmark year, we
considered the effect that the proposed regional factors, that are
discussed in section II.D.3. of the August 2018 proposed rule (83 FR
41886 through 41891), might have on the historical benchmarks for ACOs
located in a disaster area. After review, we explained that we believe
that when regional factors are applied to an ACO's historical
benchmark, the regional factors would inherently adjust for variations
in expenditures from year to year, and thus would also adjust for
regional variations in expenditures related to extreme and
uncontrollable circumstances. For example, assume that an ACO
experienced a reduction in beneficiary expenditures in performance year
2017 because a portion of its assigned beneficiaries resided in
counties that were impacted by a disaster. Then, also assume
expenditures returned to their previously higher level in 2018 and this
ACO subsequently renewed its ACO participation agreement in 2020. In
2020, when the ACO's historical benchmark would be reset (rebased), the
expenditures for 2017 (now a historical benchmark year) would be
subject to a higher regional trend factor because expenditures
increased back to the expected level in 2018, which would increase the
2017 benchmark year expenditures. Additionally, this ACO could also
have its historical benchmark increased even further as a result of its
performance compared to others in its region, as reflected in the
regional adjustment to the ACO's historical benchmark. In contrast,
consider an ACO that experienced an increase in beneficiary
expenditures in performance year 2017 because a portion of its assigned
beneficiaries resided in counties that were impacted by a disaster.
Then, assume expenditures returned to their previously lower level in
2018 and this ACO renewed its ACO participation agreement in 2020. In
2020, when the ACO's historical benchmark would be reset, the
expenditures for 2017 would be subject to a lower regional trend factor
because expenditures decreased back to the expected level in 2018,
which would decrease the 2017 benchmark year expenditures.
Additionally, this ACO could also have its historical benchmark
decreased further as a result of its performance compared to others in
its region, as reflected in the regional adjustment to the ACO's
historical benchmark.
Our expectation that the proposed regional factors that would be
used to establish an ACO's historical benchmark would also adjust for
variations in expenditures related to extreme and uncontrollable
circumstances was supported by a preliminary analysis of data for areas
that were affected by the disasters that occurred in performance year
2017. Our analysis of the data showed that, as a result of the
disasters in these areas, expenditure trends for the performance year
appeared below projections. For these areas, the expenditures began to
increase after the disaster incident period ended, but expenditures
were still below expectations for the year. Based on the expenditure
trends beginning to return to expected levels after the disaster
period, it would be reasonable to expect that expenditures would
continue to increase to expected levels in 2018. This difference
between the lower than expected levels of expenditures in 2017 and a
return to expected expenditures in 2018, would result in a higher
regional trend factor being applied to 2017 expenditures when they are
used to determine an ACO's historical benchmark. Although our analysis
for the proposed rule was performed using the proposed regional
factors, we expect that our existing benchmarking methodology at Sec.
425.603, which also incorporates regional factors in the determination
of an ACO's historical benchmark for its second or subsequent agreement
period beginning in 2017 or later years, would have a similar result.
In the August 2018 proposed rule (83 FR 41905), in considering
whether it might be necessary to make an additional adjustment to ACOs'
historical benchmarks to account for expenditure variations related to
extreme and uncontrollable circumstances, we considered an approach
where we would adjust the historical benchmark by reducing the weight
of expenditures for beneficiaries who resided in a disaster area during
a

[[Page 59978]]

disaster period and placing a correspondingly larger weight on
expenditures for beneficiaries residing outside the disaster area
during the disaster period. Such an approach would be expected to
proportionally increase the historical benchmark for ACOs that
experienced a decrease in expenditures, and conversely proportionally
decrease the historical benchmark for ACOs that experienced an increase
in expenditures for their assigned beneficiaries who were impacted by a
disaster. Under this approach, for each of the historical benchmark
years, we would identify each ACO's assigned beneficiaries who had
resided in a disaster area during a disaster period. The portion of
expenditures for these assigned beneficiaries that was impacted by the
disaster would be removed from the applicable historical benchmark
year(s). The removal of these expenditures from the historical
benchmark year(s) would allow the historical benchmark calculations to
include only expenditures that were not impacted by the disaster. We
believe this methodology for calculating benchmark expenditures would
adjust for expenditure increases or decreases that may occur as a
result of impacts related to a disaster.
We noted that if we were to implement such an adjustment to the
historical benchmark, we believed it would be appropriate to avoid
making minor historical benchmark adjustments for an ACO that was not
significantly affected by a disaster by establishing a minimum
threshold for the percentage of an ACO's beneficiaries located in a
disaster area. Based on data from 2017, quarter 3, over 80 percent of
ACOs had less than 50 percent of their assigned beneficiaries residing
in disaster counties, with over 75 percent having less than 10 percent
of their assigned beneficiaries residing in disaster counties. Based on
this data, we noted our belief that a minimum threshold of 50 percent
of assigned beneficiaries residing in disaster counties could be an
appropriate threshold for the adjustment to historical benchmarks
because historical benchmarks are calculated based on the ACO's entire
assigned beneficiary population in each benchmark year, rather than a
sample as is used for quality reporting.
However, we were concerned that this methodology for calculating an
adjustment might not be as accurate as the inherent adjustment that
would result from applying regional factors when resetting the
benchmark and may impact other expected expenditure variations
occurring in the impacted areas. For example, if an additional disaster
adjustment were to be applied, it might have unintended impacts when
expenditure truncation is applied, it might inappropriately weight and
not account for expected variations in expenditures between areas that
were and were not impacted by the disaster, and it might compound
effects that have already been offset by the regional adjustment. In
addition, the expenditures, as adjusted, may not be representative of
the ACO's actual performance and aggregate assigned beneficiary
population during the benchmark period.
In summary, we noted our belief that the regional factors that we
had proposed to apply as part of the methodology for determining an
ACO's historical benchmark would reduce the expenditures in a
historical benchmark year when they are greater than expected (relative
to other historical benchmark years) as a result of a disaster and
conversely increase expenditures in a historical benchmark year when
they are below the expected amount. For these reasons, we believed that
the proposal in section II.D.3. of the August 2018 proposed rule (83 FR
41887 through 41888) to apply regional factors when determining ACOs'
historical benchmarks, starting with an ACO's first agreement period
for agreement periods starting on July 1, 2019, and in subsequent
years, would be sufficient to address any changes in expenditures
during an ACO's historical benchmark years as a result of extreme and
uncontrollable circumstances, and an additional adjustment, such as the
method discussed previously in this section would not appear to be
necessary. However, we noted that we would continue to evaluate the
impact of the 2017 disasters on ACOs' assigned beneficiary
expenditures, and that we intended to continue to consider whether it
might be appropriate to make an additional adjustment to the historical
benchmark to account for expenditures that may have increased or
decreased in a historical benchmark year as a result of an extreme or
uncontrollable circumstance.
We solicited comments on these issues, including whether it is
necessary to adjust ACOs' historical benchmarks to account for extreme
and uncontrollable circumstances that might occur during a benchmark
year, and appropriate methods for making such benchmark adjustments. We
also noted that the proposal in section II.D.3. of the August 2018
proposed rule to apply regional factors to determine ACOs' historical
benchmarks would apply starting with an ACO's first agreement period
for agreement periods starting on July 1, 2019, and in subsequent years
and would therefore have no effect on benchmarks for ACOs in a first
agreement period starting before July 1, 2019 (see 83 FR 41887).
Accordingly, we solicited comments on whether and how an adjustment
should be made for ACOs whose benchmarks do not reflect regional
factors. We also invited comments on any additional areas where relief
may be helpful or other ways to mitigate unexpected issues that may
arise in the event of an extreme and uncontrollable circumstance.
Comment: A few commenters noted that expenditure increases in a
performance year due to a natural disaster could lead to unjustly high
benchmark year expenditures in an ACO's subsequent agreement period
which could create vulnerabilities for the Trust Funds. As described in
the prior section V.B.2.d.(2) of this final rule, we received a few
comments recommending modifications to the update that is applied to an
ACO's benchmark for a performance year that is affected by an extreme
and uncontrollable circumstance. Another commenter suggested removing
claims from benchmark and performance year expenditures that have a
disaster modifier code or are associated with a beneficiary residing a
disaster-affected area during an affected time period.
Response: As discussed in the prior section V.B.2.d.(2) of this
final rule, we intend to further consider commenters' recommendations
that we address the financial impacts of extreme and uncontrollable
circumstances through the update that is applied to the historical
benchmark and how this approach could mitigate potential negative
impacts to ACOs or to the Medicare Trust Funds for the performance year
in which a disaster occurs, performance years for which there was a
disaster in one or more of the benchmark years, or cases where an ACO
was affected by disasters in both the benchmark period and the
performance year.
As described in the prior section V.B.2.d.(2) of this final rule,
we have concerns about commenters' recommendation to exclude claims
with a natural disaster modifier code, or claims associated with
disaster affected beneficiaries and time periods from benchmark or
performance year expenditures. As we develop additional experience, we
may revisit this policy and, if warranted, propose modifications to our
methodology for calculating performance year or benchmark year
expenditures through further notice and comment rulemaking.

[[Page 59979]]

Comment: One commenter opposed using regional factors as currently
calculated by CMS to address concerns about the effect of extreme and
uncontrollable circumstances on ACOs' historical benchmarks. This
commenter disagreed with CMS' current approach, which includes ACO
assigned beneficiaries when calculating regional expenditures. They
stated that ``[A]bsent a reform that addresses the underlying issue
with the regional adjustment factor, applying it to ACOs in a region
recovering from an extreme or uncontrollable circumstance will
perpetuate the flaws.''
Response: We continue to believe that the use of regional factors
in establishing and updating the benchmark will provide an inherent
adjustment for regional variations in expenditures related to extreme
and uncontrollable circumstances. As the commenter notes, and under the
June 2016 final rule, regional expenditure calculations in the Shared
Savings Program are based on all assignable beneficiaries in an ACO's
regional service area including ACO assigned beneficiaries. We have
detailed in that earlier rule our reasons for not excluding assigned
beneficiaries from these calculations (see 81 FR 37960). Furthermore,
we do not believe that inclusion of an ACO's assigned beneficiaries
would reduce the effectiveness of regional factors to inherently adjust
for regional variations in expenditures related to extreme and
uncontrollable circumstances as we have no reason to believe that such
an event would have a differential impact on expenditures for assigned
beneficiaries relative to expenditures for assignable beneficiaries
that are not assigned to an ACO.
After considering comments we received on the determination of
historical benchmarks for ACOs in areas affected by extreme and
uncontrollable circumstances, we are not making any changes to the
benchmarking methodology to address such events at this time. We will
continue to monitor the impact of extreme and uncontrollable
circumstances on benchmark expenditures and, if applicable, the extent
to which any impact is mitigated by the use of regional factors in
establishing and updating the benchmark. If warranted, we will propose
additional modifications to our benchmarking methodology to address the
effects of extreme and uncontrollable circumstances through future
notice and comment rulemaking.
e. Program Data and Quality Measures
In section II.E.5. of the August 2018 proposed rule (41906 through
41908), we solicited comments on possible changes to the quality
measure set and modifications to program data shared with ACOs to
support CMS' Meaningful Measures initiative and respond to the nation's
opioid misuse epidemic. As part of the Meaningful Measures initiative,
the agency's efforts are focused on updating quality measures, reducing
regulatory burden, and promoting innovation (see CMS Press Release, CMS
Administrator Verma Announces New Meaningful Measures Initiative and
Addresses Regulatory Reform; Promotes Innovation at LAN Summit, October
30, 2017, available at https://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2017-Press-releases-items/2017-10-30.html). Under the Meaningful Measures initiative, we are working
towards assessing performance on only those core issues that are most
vital to providing high-quality care and improving patient outcomes,
with an emphasis on outcome-based measures, reducing unnecessary burden
on providers, and putting patients first. When we developed the quality
reporting requirements under the Shared Savings Program, we considered
the quality reporting requirements under other initiatives, such as the
Physician Quality Reporting System (PQRS) and Million Hearts
Initiative, and consulted with the measures community to ensure that
the specifications for the measures used under the Shared Savings
Program are up-to-date and reduce reporting burden.
Since the Shared Savings Program was first established in 2012, we
have not only updated the quality measure set to reduce reporting
burden, but also to focus on more meaningful outcome-based measures.
The most recent updates to the Shared Savings Program quality measure
set were made in the CY 2017 PFS Final Rule (81 FR 80484 through 80489)
to adopt the ACO measure recommendations made by the Core Quality
Measures Collaborative, a multi-stakeholder group with the goal of
aligning quality measures for reporting across public and private
stakeholders in order to reduce provider reporting burden. Currently,
more than half of the 31 Shared Savings Program quality measures are
outcome-based, including--
Patient-reported outcome measures collected through the
CAHPS for ACOs Survey that strengthen patient and caregiver experience;
Outcome measures supporting care coordination and
effective communication, such as unplanned admission and readmission
measures; and
Intermediate outcome measures that address the effective
treatment of chronic disease, such as hemoglobin A1c control for
patients with diabetes and control of high blood pressure.
As we explained in the August 2018 proposed rule (83 FR 41906), it
is important that the quality reporting requirements under the Shared
Savings Program align with the reporting requirements under other
Medicare initiatives and those used by other payers in order to
minimize the need for Shared Savings Program participants to devote
excessive resources to understanding differences in measure
specifications or engaging in duplicative reporting. We sought comment,
including recommendations and input on meaningful measures, on how we
may be able to further advance the quality measure set for ACO
reporting, consistent with the requirement under section 1899(b)(3)(C)
of the Act that the Secretary seek to improve the quality of care
furnished by ACOs by specifying higher standards, new measures, or
both.
One particular area of focus by the Department of Health and Human
Services is the opioid misuse epidemic. The Centers for Disease Control
and Prevention (CDC) reports that the number of people experiencing
chronic pain lasting more than 3 months is estimated to include 11
percent of the adult population. According to a 2016 CDC publication, 2
million Americans had opioid use disorder (OUD) associated with
prescription opioids in 2014 (https://www.cdc.gov/drugoverdose/prescribing/guideline.html). Since the implementation of Medicare Part
D in 2006 to cover prescription medications, the Medicare program has
become the largest payer for prescription opioids in the United States
(Zhou et al., 2016; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4955937/). Safe and effective opioid prescribing for older adults is
of particular importance because misuse and abuse of opioids can lead
to increased adverse events in this population (for example, increased
falls, fractures, hospitalization, ER visits, mortality), especially
given the high prevalence of polypharmacy in the elderly. Polypharmacy
is the simultaneous use of multiple drugs by a single patient, for one
or more conditions, which increases the risk of adverse events. For
example, a study by MedPAC found that some beneficiaries

[[Page 59980]]

who use opioids fill more than 50 prescriptions among 10 drug classes
annually (https://www.medpac.gov/docs/default-source/reports/chapter-5-polypharmacy-and-opioid-use-among-medicare-part-d-enrollees-june-2015-report-.pdf?sfvrsn=0, MedPAC, 2015).
As part of a multifaceted response to address the growing problem
of overuse and abuse of opioids in the Part D program, CMS adopted a
policy in 2013 requiring Medicare Part D plan sponsors to implement
enhanced drug utilization review. Between 2011 through 2014, there was
a 26 percent decrease or 7,500 fewer Medicare Part D beneficiaries
identified as potential opioid over-utilizers which may be due, at
least in part, to these new policies. On January 5, 2017, CMS released
its Opioid Misuse Strategy. This document outlines CMS' strategy and
the array of actions underway to address the national opioid misuse
epidemic and is available at https://www.cms.gov/Outreach-and-Education/Outreach/Partnerships/Downloads/CMS-Opioid-Misuse-Strategy-2016.pdf.
We aim to align our policies under the Shared Savings Program with
the priorities identified in the Opioid Misuse Strategy and the
Department of Health and Human Services Strategy to Combat Opioid
Abuse, Misuse, and Overdose \36\ and to help ACOs and their
participating providers and suppliers in responding to and managing
opioid use, and are therefore considering several actions to improve
alignment. Specifically, as we described in the August 2018 proposed
rule, we are considering what information regarding opioid use,
including information developed using aggregate Medicare Part D data,
could be shared with ACOs. We are also considering the addition of one
or more measures specific to opioid use to the ACO quality measures
set. The potential benefits of such policies would be to focus ACOs on
the appropriate use of opioids for their assigned beneficiaries and
support their opioid misuse prevention efforts.
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\36\ https://www.hhs.gov/opioids/sites/default/files/2018-09/opioid-fivepoint-strategy-20180917-508compliant.pdf.
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First, we are considering what information, including what
aggregated Medicare Part D data, could be useful to ACOs to combat
opioid misuse in their assigned beneficiary population. We recognize
the importance of available and emerging resources regarding the opioid
epidemic at the federal, state, and local level, and intend to work
with our federal partners to make relevant resources available in a
timely manner to support ACOs' goals and activities. We will also
continue to share information with ACOs highlighting Federal opioid
initiatives, such as the CDC Guideline for Prescribing Opioids for
Chronic Pain (https://www.cdc.gov/drugoverdose/prescribing/guideline.html), which reviews the CDC's recommended approach to opioid
prescribing, and the Surgeon General's report on Substance Use and
Addiction, Facing Addiction in America: The Surgeon General's Report on
Alcohol, Drugs, and Health, (https://addiction.surgeongeneral.gov/)
which focuses on educating and mobilizing prescribers to take action to
end the opioid epidemic by improving prescribing practices, informing
patients about the risks of and resources for opioid addiction, and
encouraging health care professionals to take a pledge to end the
opioid crisis. We also intend to continue to highlight information
about the opioid crisis and innovations for opioid treatment and
prevention strategies in ACO communications and webinars by including
topics such as innovative uses of health IT for opioid use disorder
treatment and specifically for electronic clinical decision support
consistent with the CDC guidelines, as available.
Although we recognize that not all beneficiaries assigned to Shared
Savings Program ACOs have Part D coverage, we believe a sufficient
number do have Part D coverage to make aggregate Part D data regarding
opioid use helpful for the ACOs. As an example, we have found the
following information for performance year 2016:
Approximately 70 percent of beneficiaries assigned to ACOs
participating in the Shared Savings Program had continuous Part D
coverage.
For assigned beneficiaries with continuous Part D
enrollment, almost 37 percent had at least one opioid prescription.
This percentage ranged from 10.6 percent to 58.3 percent across ACOs.
The mean number of opioid medications filled per assigned
beneficiary (with continuous Part D coverage) varied across ACOs,
ranging from 0.3 to 4.5 prescriptions filled, with an average of 2.1
prescriptions filled.
The number of opioid prescriptions filled for each
assigned beneficiary with at least one opioid prescription filled
varied across ACOs and ranged from 2.6 to 8.4 prescriptions, with an
average of 5.5 opioid prescriptions filled.
ACOs currently receive, as part of the monthly claims and claims
line feed data, Part D prescription drug event (PDE) data on prescribed
opioids for their assigned beneficiaries who have not opted out of data
sharing. We encourage ACOs to use this beneficiary-level data in their
care delivery practices.
In the August 2018 proposed rule (83 FR 41907), we sought
suggestions for other types of aggregate data related to opioid use
that could be added for informational purposes to the aggregate
quarterly and annual reports CMS provides to ACOs. The aim would be for
ACOs to utilize this additional information to improve population
health management for assigned beneficiaries, including prevention,
identifying anomalies, and coordinating care. The type of aggregate
data should be highly relevant for a population-based program at the
national level and have demonstrated value in quality improvement
initiatives. We noted that we are particularly interested in high
impact aggregate data that would reflect gaps in quality of care,
patient safety, multiple aspects of care, and drivers of cost. We aim
to provide aggregate data that have validity for longitudinal analysis
to enable both ACOs and the Shared Savings Program to trend performance
across time and monitor for changes. Aggregate data on both processes
and outcomes are appropriate, provided that the data are readily
available. Types of aggregate data that we have begun to consider,
based on the information available from prescription drug event records
for assigned beneficiaries enrolled in Medicare Part D, include filled
prescriptions for opioids (percentage of the ACO's assigned
beneficiaries with any opioid prescription, number of opioid
prescriptions per opioid user), number of beneficiaries with a
concurrent prescription of opioids and benzodiazepines; and number of
beneficiaries with opioid prescriptions above a certain daily Morphine
Equivalent Dosage threshold. We also sought comments on measures that
could be added to the quality measure set for the purpose of addressing
the opioid epidemic and addiction, more generally. We sought comment on
measures related to various aspects of opioid use, such as prevention,
pain management, or opioid use disorder treatment, and on measures
related to addiction. In particular, we noted that we were considering
the following relevant NQF-endorsed measures, with emphasis on Medicare
beneficiaries with Part D coverage who are 18 years or older without
cancer or enrolled in hospice:
NQF #2940 Use of Opioids at High Dosage in Persons Without
Cancer: Analyzes the proportion (XX out of 1,000) of Medicare Part D
beneficiaries

[[Page 59981]]

18 years or older without cancer or enrolled in hospice receiving
prescriptions for opioids with a daily dosage of morphine milligram
equivalent (MME) greater than 120 mg for 90 consecutive days or longer.
NQF #2950 Use of Opioids from Multiple Providers in
Persons Without Cancer: Analyzes the proportion (XX out of 1,000) of
Medicare Part D beneficiaries 18 years or older without cancer or
enrolled in hospice receiving prescriptions for opioids from four (4)
or more prescribers AND four (4) or more pharmacies.
NQF #2951 Use of Opioids from Multiple Providers and at
High Dosage in Persons Without Cancer: Analyzes the proportion (XX out
of 1,000) of Medicare Part D beneficiaries 18 years or older without
cancer or enrolled in hospice with a daily dosage of morphine milligram
equivalent (MME) greater than 120 mg for 90 consecutive days or longer,
AND who received opioid prescriptions from four (4) or more prescribers
AND four (4) or more pharmacies.
In addition, we sought input on potential measures for which data
are readily available, such as measures that might be appropriately
calculated using Part D data, and that capture performance on outcomes
of appropriate opioid management. We requested that comments on
measures that are not already NQF endorsed include descriptions of
reliability, validity, benchmarking, the population in which the
measure was tested, along with the data source that was used, and
information on whether the measure is endorsed and by what
organization. We recognized that measures of the various aspects of
opioid use may involve concepts related to integrated, coordinated, and
collaborative care, including as applicable for co-occurring and/or
chronic conditions, as well as measures that reflect the impact of
interventions on patient outcomes, including direct and indirect
patient outcome measures. We also sought comment on opioid-related
measures that would support effective measurement alignment of
substance use disorders across programs, settings, and varying
interventions.
Comment: A majority of commenters supported CMS' focus on burden
reduction stating that they are encouraged by the administration's
efforts to reduce reporting burden for healthcare providers. However,
one commenter cautioned that although decreasing burden is a laudable
goal, removing process measures could unfairly impact the quality
scores of healthcare providers who care for vulnerable patients exposed
to the harshest social determinants of health. Several commenters
suggested that CMS strive toward a core measure set that identifies and
harmonizes measures across multiple CMS programs, so that incentives
and goals are aligned across healthcare providers and care settings.
Several commenters supported the agency's Meaningful Measures
Initiative stating that CMS should not only consider whether a measure
is a process measure, but also whether the measure is considered a low-
value process measure, before removing it from the Shared Savings
Program quality measure set. In addition, these commenters supported
CMS' move toward the use of outcome measures, as the emphasis on
improved health outcomes is an appropriate focus and goal.
Several commenters suggested future potential refinements to the
Shared Savings Program measure set. One commenter urged CMS to better
align the Shared Savings Program with Medicare Advantage, suggesting
that there should be fewer measures that are included in a roadmap for
implementation in both programs, because the different measures and the
differing standards for compliance that are currently used cause
confusion and require the use of limited provider and staff resources.
In addition, this commenter stated that with a roadmap of measures,
organizations would be able to focus their energies on achieving these
metrics in a systematic and deliberate fashion.
Another commenter expressed concern with the timing and burden of
quality measurement and payment, suggesting that we streamline quality
efforts to include ten specific outcome measures that have a social and
public health impact and offering a financial incentive in connection
with each measure to encourage physicians to drive, fund, and sustain
continued quality efforts.
A few commenters suggested that CMS should focus on the prevention,
treatment, and management of behavioral health. They stated that in the
absence of effective behavioral health assessment tools, the vast
majority of people with mental health conditions go unidentified in
primary care settings, which in most cases leads to non-adherent
patients and higher total medical costs. In addition, they stated that
behavioral health is central to the prevention, treatment, and
management of the preventable manifestations of diseases and health
conditions. They suggested that CMS consider including broader measures
that would encourage behavioral health and medical providers to work
collaboratively to provide coordinated care.
Several commenters suggested that CMS consider developing a quality
measure set that would evaluate the breadth of chronic conditions
common in the patient population assigned to Shared Savings Program
ACOs and use appropriate outcome measures to ensure assigned
beneficiaries are receiving the necessary care. They noted that the
proposed Shared Savings Program quality measure set discussed in
section III.F.1.c. of the CY 2019 PFS proposed rule (83 FR 35876
through 35878) does not include measures related to respiratory
conditions, like chronic obstructive pulmonary disease or asthma,
diabetes, or additional conditions like heart failure. They encouraged
CMS to include measures that evaluate the quality of care for these
conditions, such as, measures focused on the delivery of comprehensive
lower extremity exams for diabetic patients, and rates of complications
such as amputation. They stated that greater emphasis on management of
chronic conditions is necessary to promote quality and improve patient
outcomes. Another commenter suggested CMS should increase the number of
claims-based measures in the Shared Savings Program measure set and
provide ACOs with user-friendly, actionable reports that detail the
ACO-specific data used to calculate specific measure performance. One
commenter suggested that CMS consider quality measures that reinforce
shared decision making, as part of treatment plans that align with the
individual's goals as this is a foundational component of high-quality
patient-centered care.
Response: We thank the commenters for their thoughtful input on the
quality measures used to assess the performance of ACOs under the
Shared Savings Program. As we plan for future updates and changes to
the Shared Savings Program quality measure set, we will consider this
feedback in the development of our proposals.
Comment: The majority of commenters that addressed the potential
inclusion of measures related to opioid use in the Shared Savings
Program quality measure set were supportive of this effort. A few
commenters noted that continued support and recognition for integration
of EHRs and electronic sharing of health information, would promote
improved communication between healthcare providers, which may help
curb opioid abuse and addiction.

[[Page 59982]]

Several commenters supported CMS' efforts to consider the possible
addition of opioid use measures to the Shared Savings Program quality
measure set in future program years, but some commenters recommended
that CMS work with the measure developer and NQF to reduce the dosage
threshold of two of the measures discussed in the August 2018 proposed
rule to 90 MME per day to align with the CDC guidelines for Prescribing
Opioids for Chronic Pain. Another commenter agreed that promoting the
measurement of opioid use and overuse, monitoring, and education
through quality reporting is an important step in understanding and
addressing the opioid crisis. A few commenters recommended that CMS
utilize the Prescription Drug Monitoring Program (PDMP) Query measure,
as most states have implemented PDMPs, and the PDMP Query measure is a
reasonable step to improve and measure quality in opioid prescribing.
Another commenter stated that in general they support CMS'
considering the addition of opioid use measures to the Shared Savings
Program measure set; however, they expressed their belief that opioid
dosage measures are of low-value to the program because, ``. . . since
the issuance of Centers for Disease Control (CDC) and Prevention
guidelines, there have been many reports of patients who have been
successfully managed on opioid analgesics for long periods of time.''
This commenter noted that implementing a quality measure that could
force a health provider to abruptly reduce or discontinue this
medication regimen could have extreme adverse outcomes such as
depression, loss of function, or even suicide. The commenter suggested
CMS consider quality measures other than dosage measures when
determining the most appropriate metrics to help address and respond to
the opioid crisis.
One commenter expressed concern with the specific opioid related
measures on which CMS sought comment for potential inclusion in the
Shared Savings Program quality measure set. The commenter stated that
quality measurement needs to focus on utilization of preventive
strategies, such as screening and treatment for substance abuse, as
well as pain management. This commenter disagreed with the potential
inclusion of NQF #2940: Use of Opioids at Higher Dosage in Persons
Without Cancer because a measure that focuses only on daily dose and
duration of therapy involving prescription opioid analgesics, on its
own is not a good indication of quality patient care. In addition, they
expressed concerns with the potential inclusion of NQF #2950: Use of
Opioids from Multiple Providers in Persons Without Cancer and NQF
#2951: Use of Opioids from Multiple Providers and at High Dosage in
Persons Without Cancer in the Shared Savings Program measure set, as
these measures were developed with the intention of determining the
quality of care provided by prescription drug health plans and because
of the lack of information on the feasibility of ACOs' collecting and
reporting pharmacy claims data.
Another commenter noted that the three opioid measures CMS
suggested for inclusion in the Shared Savings Program measure set are
appropriately focused on the right patient population and address the
major risks associated with opioid misuse--high dosages and multiple
prescriptions. However, the commenter urged CMS to conduct testing to
ensure the measures provide accurate, reliable data at the ACO level,
as they are currently endorsed at the health plan level not the ACO
level. The commenter suggested that the measures should be reported on
a voluntary or pay-for-reporting basis rather than as pay-for-
performance measures for the first few years after they are added to
the measure set.
Another commenter expressed concern that including measures that
are so specific will distract ACOs from focusing on what works for them
and their assigned beneficiary population. As an alternative, the
commenter suggested CMS provide webinars, education, tools, and data
for ACOs to incorporate into their current structure for care
management and patient engagement. Several commenters recommended that
CMS provide aggregated data to ACOs on opioid use, but they also urged
CMS to go further and provide aggregated beneficiary data on the use of
all prescribed medications and their related diagnoses. Similarly,
another commenter encouraged CMS to continue to add more real-time data
to the quarterly quality reports so providers can leverage this data to
improve patient care, address social inequities in health, correct
inefficiencies to drive down costs, and help to address the nation's
opioid epidemic and other pressing health crises.
Response: We thank the commenters for their thoughtful input on the
possible addition of measures related to opioid use to the quality
measure set for the Shared Savings Program. As we plan for future
updates and changes to the Shared Savings Program quality measure set,
we will consider this feedback from commenters before making any
proposals with respect to the addition of opioid use measures.
f. Promoting Interoperability
Consistent with the call in the 21st Century Cures Act for
interoperable access, exchange, and use of health information, the
final rule entitled, 2015 Edition Health Information Technology (Health
IT) Certification Criteria, 2015 Edition Base Electronic Health Record
(EHR) Definition, and ONC Health IT Certification Program Modifications
(2015 Edition final rule) (80 FR 62601) under 45 CFR part 170 \37\
focused on health IT certification criteria that support patient care,
patient participation in care delivery, and electronic exchange of
interoperable health information. The 2015 Edition final rule, which
was issued on October 16, 2015, aimed to improve interoperability by
adopting new and updated vocabulary and content standards for the
structured recording and exchange of health information and to
facilitate the accessibility and exchange of data by including enhanced
data export, transitions of care, and application programming interface
capabilities. These policies are relevant to assessing the use of CEHRT
under the Quality Payment Program, Shared Savings Program, and other
value based payment initiatives.
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\37\ For more information, see https://www.healthit.gov/sites/default/files/understanding-certified-health-it-2.pdf.
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Under the Shared Savings Program, section 1899(b)(2)(G) of the Act
requires participating ACOs to define processes to report on quality
measures and coordinate care, such as through the use of telehealth,
remote patient monitoring, and other such enabling technologies.
Consistent with the statute, ACOs participating in the Shared Savings
Program are required to coordinate care across and among primary care
physicians, specialists, and acute and post-acute providers and
suppliers and to have a written plan to encourage and promote the use
of enabling technologies for improving care coordination, including the
use of electronic health records and electronic exchange of health
information (Sec. 425.112(b)(4)). Additionally, since the inception of
the program in 2012, CMS has assessed the level of CEHRT use by certain
clinicians in the ACO using a double-weighted quality measure (Use of
Certified EHR Technology, ACO-11) as part of the quality reporting
requirements for each performance year. Based on previously-finalized
policies, for the 2018 performance year, we will use data derived from
the Quality

[[Page 59983]]

Payment Program's Promoting Interoperability performance category to
calculate the percentage of eligible clinicians participating in an ACO
who successfully meet the Advancing Care Information Performance
Category Base Score for purposes of ACO-11. Because the measure is used
in determining an ACO's quality score and for determining shared
savings or shared losses under the Shared Savings Program, all eligible
clinicians participating in Shared Savings Program ACOs must submit
data for the Quality Payment Program's Advancing Care Information
performance category for performance year 2018, including those
eligible clinicians who are participating in Shared Savings Program
tracks that have been designated as Advanced APMs and who have met the
QP threshold or are otherwise not subject to the MIPS reporting
requirements.
In the August 2018 proposed rule (83 FR 41908), we noted that some
alternative payment models tested by the Innovation Center, require all
participants to use CEHRT even though certain tracks within those
Models do not meet the financial risk standard for designation as
Advanced APMs. The primary rationale for this requirement is to promote
CEHRT use by eligible clinicians and organizations participating in
APMs by requiring them to demonstrate a strong commitment to the
exchange of health information, regardless of whether they are
participating in an APM that meets the criteria to be designated as an
Advanced APM. Under the Quality Payment Program, an incentive payment
will be made to certain Qualifying APM Participants (QPs) participating
in Advanced APMs. Beginning in 2017, an eligible clinician can become a
QP for the year by participating sufficiently in an Advanced APM during
the QP performance period. Eligible clinicians who are QPs for a year
receive a lump sum APM incentive payment for payment years from 2019
through 2024, and are excluded from the MIPS reporting requirements for
the performance year and the MIPS payment adjustment for the payment
year. In the CY 2017 Quality Payment Program final rule (81 FR 77408),
we finalized the criteria that define an Advanced APM based on the
requirements set forth in sections 1833(z)(3)(C) and (D) of the Act. An
Advanced APM is an APM that, among other criteria, requires its
participants to use CEHRT. In the CY 2017 Quality Payment Program final
rule, we established that Advanced APMs meet this requirement if the
APM either--(1) requires at least 50 percent of eligible clinicians in
each participating APM Entity, or for APMs in which hospitals are the
APM Entities, each hospital, to use CEHRT to document and communicate
clinical care to their patients or other health care providers; or (2)
for the Shared Savings Program, applies a penalty or reward to an APM
Entity based on the degree of the use of CEHRT of the eligible
clinicians in the APM Entity (Sec. 414.1415(a)(1)(i) and (ii)). In the
CY 2017 PFS final rule, we updated the title and specifications of the
EHR quality measure (ACO-11) to align with the Quality Payment Program
criterion on CEHRT use in order to ensure that certain tracks under the
Shared Savings Program could meet the criteria to be Advanced APMs.
Specifically, we revised the ACO-11 measure to assess ACOs on the
degree of CEHRT use by all eligible clinicians participating in the
ACO. Performance on the measure is determined by calculating the
percentage of eligible clinicians participating in the ACO who
successfully meet the Promoting Interoperability Performance Category
Base Score.
In light of our additional experience with the Shared Savings
Program, our desire to continue to promote and encourage CEHRT use by
ACOs and their ACO participants and ACO providers/suppliers, and our
desire to better align with the goals of the Quality Payment Program
and the criteria for participation in certain alternative payment
models tested by the Innovation Center, in the August 2018 proposed
rule, we indicated that we believe it would be appropriate to amend our
regulations related to CEHRT use and the eligibility requirements for
ACOs to participate in the Shared Savings Program. Specifically, we
proposed to add a requirement that all ACOs demonstrate a specified
level of CEHRT use in order to be eligible to participate in the Shared
Savings Program. Additionally, we proposed that, as a condition of
participation in a track, or a payment model within a track, that meets
the financial risk standard to be an Advanced APM, ACOs must certify
that the percentage of eligible clinicians participating in the ACO who
use CEHRT to document and communicate clinical care to their patients
or other health care providers meets or exceeds the threshold required
for Advanced APMs as defined under the Quality Payment Program (Sec.
414.1415(a)(1)(i)). In conjunction with this proposed new eligibility
requirement, we proposed to retire the EHR quality measure (ACO-11)
related to CEHRT use, thereby reducing reporting burden, effective for
quality reporting for performance years starting on January 1, 2019,
and subsequent performance years. In addition, consistent with our
proposal to align with the Advanced APM criterion on use of CEHRT, we
proposed to apply the definition of CEHRT under the Quality Payment
Program (Sec. 414.1305), including any subsequent updates to this
definition, for purposes of the Shared Savings Program by adding a
definition of ``CEHRT'' to Sec. 425.20.
First, we proposed that for performance years starting on January
1, 2019, and subsequent performance years, ACOs in a track or a payment
model within a track that does not meet the financial risk standard to
be an Advanced APM would have to attest and certify upon application to
participate in the Shared Savings Program, and subsequently, as part of
the annual certification process, that at least 50 percent of the
eligible clinicians participating in the ACO use CEHRT to document and
communicate clinical care to their patients or other health care
providers. ACOs would be required to submit this certification in the
form and manner specified by CMS.
We stated that our proposed requirement aligned with the
requirements regarding CEHRT use in many alternative payment models
being tested by the Innovation Center. Additionally, we noted that at
the time of application, ACOs must have a written plan to use enabling
technologies, such as electronic health records and other health IT
tools, to coordinate care (Sec. 425.112(b)(4)(i)(C)). Over the years,
successful ACOs have impressed upon us the importance of ``hitting the
ground running'' on the first day of their participation in the Shared
Savings Program, rather than spending the first year or two developing
their care processes. We stated our belief that requiring ACOs that are
entering a track or a payment model within a track that does not meet
the financial risk standard to be an Advanced APM to certify that at
least 50 percent of the eligible clinicians participating in the ACO
use CEHRT would align with existing requirements under the Shared
Saving Program and many Innovation Center alternative payment models
and encourage participation by organizations that are more likely to
meet the program goals. In addition, we stated that such a requirement
would also promote greater emphasis on the importance of CEHRT use for
care coordination. Finally, we noted that in the CY 2019 PFS proposed
rule, we had proposed to increase the threshold of

[[Page 59984]]

CEHRT use required for APMs to meet criteria for designation as
Advanced APMs under the Quality Payment Program to 75 percent (see 83
FR 35990). Given our proposed updates and modifications to the Shared
Savings Program tracks in the August 2018 proposed rule, as well as the
proposed changes to the requirements regarding CEHRT use under the
Quality Payment Program, we explained that we believe it is important
that only those ACOs that are likely to be able to meet or exceed the
threshold designated for Advanced APMs should be eligible to enter and
continue their participation in the Shared Savings Program. Because of
this, and also our desire to align requirements across the different
payment models and tracks in Shared Savings Program, as explained in
more detail later in this section, we also considered whether to
propose to require all Shared Savings Program ACOs, including ACOs in
tracks or payment models within tracks that would not meet the
financial criteria to be designated as Advanced APMs, to meet the 75
percent threshold proposed under the Quality Payment Program.
We proposed changes to the regulations at Sec. 425.204(c) (to
establish the new application requirement) and Sec. 425.302(a)(3)(iii)
(to establish the new annual certification requirement). We also
proposed to add a new provision at Sec. 425.506(f)(1) to indicate that
for performance years starting on January 1, 2019, and subsequent
performance years, all ACOs in a track or a payment model within a
track that does not meet the financial risk standard to be an Advanced
APM must certify that at least 50 percent of their eligible clinicians
use CEHRT to document and communicate clinical care to their patients
or other health care providers. We noted that this proposal, if
finalized, would not affect the previously-finalized requirements for
MIPS eligible clinicians reporting on the Promoting Interoperability
(PI) performance category under MIPS. In other words, MIPS eligible
clinicians who are participating in ACOs would continue to report as
usual on the Promoting Interoperability performance category. We
welcomed comment on these proposed changes. We also sought comment on
whether the percentage of CEHRT use should be set at a level higher
than 50 percent for ACOs in a track or a payment model within a track
that does not meet the financial risk standard to be an Advanced APM
given that average ACO performance on the Use of Certified EHR
Technology measure (ACO-11) has substantially exceeded 50 percent, with
ACOs reporting that on average roughly 80 percent of primary care
physicians in their ACOs meet meaningful use requirements,\38\
suggesting that a higher threshold may be warranted now or in the
future. We noted that a higher threshold percentage (such as 75
percent) would align with the proposed changes to the CEHRT use
requirement under the Quality Payment Program that were included in the
CY 2019 PFS proposed rule.
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\38\ This estimate is based on calculations of primary care
physician CEHRT use prior to the changes made to ACO-11 to align
with the Quality Payment Program, which became effective for quality
reporting for performance year 2017.
---------------------------------------------------------------------------

Further, for ACOs in tracks or models that meet the financial risk
standard to be Advanced APMs under the Quality Payment Program, we
proposed to align the proposed CEHRT use threshold with the criterion
on use of CEHRT established for Advanced APMs under the Quality Payment
Program. We noted that, although it would be ideal for all ACOs to meet
the same CEHRT thresholds to be eligible for participation in the
Shared Savings Program, there may be reasons why it may be desirable
for ACOs in tracks or payment models within a track that do not meet
the financial risk standard for Advanced APMs to have a different
threshold requirement for CEHRT use than more sophisticated ACOs that
are participating in tracks or payment models that qualify as Advanced
APMs under the Quality Payment Program. For example, we noted that in
order for an APM to meet the criteria to be an Advanced APM under the
Quality Payment Program, it must currently require at least 50 percent
of eligible clinicians in each participating APM entity to use CEHRT to
document and communicate clinical care to their patients or other
health care providers (in addition to certain other criteria). However,
as previously noted, in the CY 2019 PFS proposed rule, we proposed to
increase this threshold level under the Quality Payment Program to 75
percent of eligible clinicians in each participating Advanced APM
entity. Therefore, for performance years starting on January 1, 2019,
and subsequent performance years for Shared Savings Program tracks (or
payment models within tracks) that meet the financial risk standard to
be an Advanced APM, we proposed to align the CEHRT requirement with the
Quality Payment Program Advanced APM CEHRT use criterion at Sec.
414.1415(a)(1)(i). Specifically, we proposed that such ACOs would be
required to certify that they meet the higher of the 50 percent
threshold proposed for ACOs in a track (or a payment model within a
track) that does not meet the financial risk standard to be an Advanced
APM or the CEHRT use criterion for Advanced APMs under the Quality
Payment Program at Sec. 414.1415(a)(1)(i). We stated that requiring
these ACOs to meet the higher of the 50 percent threshold proposed for
ACOs in a track (or a payment model within a track) that does not meet
the financial risk standard to be an Advanced APM or the CEHRT use
criterion for Advanced APMs would ensure alignment of eligibility
requirements across all Shared Savings Program ACOs, while also
ensuring that if the CEHRT use criterion for Advanced APMs were higher
than 50 percent, those Shared Savings Program tracks (or payment models
within a track) that meet the financial risk standard to be an Advanced
APM would also meet the CEHRT threshold established under the Quality
Payment Program. We anticipated that for performance years starting on
January 1, 2019, the tracks (or payment models within tracks) that
would be required to meet the CEHRT threshold designated at Sec.
414.1415(a)(1)(i) would include Track 2, Track 3, and the Track 1+
Model, and for performance years starting on July 1, 2019, would
include the proposed BASIC track, Level E, and the proposed ENHANCED
track. ACOs in these tracks (or a payment model within such a track)
would be required to attest and certify that the percentage of the
eligible clinicians in the ACO that use CEHRT to document and
communicate clinical care to their patients or other health care
providers meets or exceeds the level of CEHRT use specified under the
Quality Payment Program regulation at Sec. 414.1415(a)(1)(i). We noted
that although this proposal might cause Shared Savings Program ACOs in
different tracks (or different payment models within the same track) to
be held to different requirements regarding CEHRT use, we believed it
would be appropriate to ensure not only that ACOs that are still new to
participation in the Shared Savings Program would not be excluded from
the program due to a requirement that a high percentage of eligible
clinicians participating in the ACO use CEHRT, but also that eligible
clinicians in ACOs further along the risk continuum would have the
opportunity to participate in an Advanced APM for purposes of the
Quality Payment Program.
We proposed to add a new provision to the regulations at Sec.
425.506(f)(2) to

[[Page 59985]]

establish the CEHRT requirement for performance years starting on
January 1, 2019, and subsequent performance years for ACOs in a track
or a payment model within a track that meets the financial risk
standard to be an Advanced APM under the Quality Payment Program. These
ACOs would be required to certify that the percentage of eligible
clinicians participating in the ACO that use CEHRT to document and
communicate clinical care to their patients or other health care
providers meets or exceeds the higher of 50 percent or the threshold
for CEHRT use by Advanced APMs at Sec. 414.1415(a)(1)(i). We sought
comment on this proposal. We also sought comment on whether we should
apply the same standard regarding CEHRT use across all Shared Savings
Program ACOs, including ACOs participating in tracks or payment models
within tracks that do not meet the financial risk standard to be
designated as Advanced APMs, specifically Track 1 and the proposed
BASIC track, Levels A through D, or maintain the proposed 50 percent
requirement for these ACOs as they gain experience on the glide path to
performance-based risk.
We stated that, as a part of these proposals to require ACOs to
certify that a specified percentage of their eligible clinicians use
CEHRT, CMS would reserve the right to monitor, assess, and/or audit an
ACO's compliance with respect to its certification of CEHRT use among
its participating eligible clinicians, consistent with Sec. Sec.
425.314 and 425.316, and to take compliance actions (including warning
letters, corrective action plans, and termination) as set forth at
Sec. Sec. 425.216 and 425.218 when ACOs fail to meet or exceed the
required CEHRT use thresholds. Additionally, we proposed to adopt for
purposes of the Shared Savings Program the same definition of ``CEHRT''
as is used under the Quality Payment Program. We proposed to amend
Sec. 425.20 to incorporate a definition of CEHRT consistent with the
definition at Sec. 414.1305, including any subsequent updates or
revisions to that definition. Consistent with this proposal and to
ensure alignment with the requirements regarding CEHRT use under the
Quality Payment Program, we also proposed to amend Sec. 425.20 to
incorporate the definition of ``eligible clinician'' at Sec. 414.1305
that applies under the Quality Payment Program.
Additionally, we stated that if the proposal to introduce a
specified threshold of CEHRT use as an eligibility requirement for
participation in the Shared Savings Program is finalized, we believed
this new requirement should replace the current ACO quality measure
that assesses the Use of Certified EHR Technology (ACO-11). We
explained that the proposed new eligibility requirement, which would be
assessed through the application process and annual certification,
would help to meet the goals of the program and align with the approach
used in other MIPS APMs. Moreover, the proposed new requirement would
render reporting on the Use of Certified EHR Technology quality measure
unnecessary in order for otherwise eligible tracks (and payment models
within tracks) to meet the Advanced APM criterion regarding required
use of CEHRT under Sec. 414.1415(a)(1)(i). As a result, continuing to
require ACOs to report on this measure would impose undue reporting
burden on eligible clinicians that meet the QP threshold and would
otherwise not be required to report the Promoting Interoperability
performance category for purposes of the Quality Payment Program.
Therefore, we proposed to remove the Use of Certified EHR Technology
measure (ACO-11) from the Shared Savings Program quality measure set,
effective with quality reporting for performance years starting on
January 1, 2019, and subsequent performance years. We proposed
corresponding changes to the regulation at Sec. 425.506. We also
reiterated that the removal of the Use of Certified EHR Technology
measure (ACO-11) from the quality measure set used under the Shared
Savings Program, if finalized, would not affect policies under MIPS for
reporting on the Promoting Interoperability performance category and
scoring under the APM Scoring Standard for MIPS eligible clinicians in
MIPS APMs. In other words, eligible clinicians subject to MIPS (such as
eligible clinicians in the proposed BASIC track, Levels A through D,
Track 1, and other MIPS eligible clinicians who are required to report
on the Promoting Interoperability performance category for purposes of
the Quality Payment Program) would continue to report as usual on the
Promoting Interoperability performance category. However, data reported
for purposes of the Promoting Interoperability performance category
under MIPS would not be used to assess the ACO's quality performance
under the Shared Savings Program. We welcomed public comment on the
proposal to remove the quality measure on Use of Certified EHR
Technology (ACO-11) from the Medicare Shared Savings Program measure
set, effective for quality reporting for performance years starting on
January 1, 2019, and subsequent performance years.
Finally, as discussed previously in this section, in the CY 2017
Quality Payment Program final rule, CMS finalized a separate Advanced
APM CEHRT use criterion that applies for the Shared Savings Program at
Sec. 414.1415(a)(1)(ii). To meet the Advanced APM CEHRT use criterion
under the Shared Savings Program, a penalty or reward must be applied
to an APM Entity based upon the degree of CEHRT use among its eligible
clinicians. We believed that this alternative criterion was appropriate
to assess the Advanced APM CEHRT use requirement under the Shared
Savings Program because, at the time, a specific level of CEHRT use was
not required for participation in the program (81 FR 77412).
As we explained in the August 2018 proposed rule (83 FR 41911), our
proposal to impose specific CEHRT use requirements on ACOs
participating in the Shared Savings Program would eliminate the need
for the separate CEHRT use criterion applicable to the Shared Savings
Program APMs found at Sec. 414.1415(a)(1)(ii). We noted that if the
proposal to incorporate specific requirements regarding the use of
CEHRT by Shared Savings Program ACOs were finalized, ACOs seeking to
participate in a Shared Savings Program track (or payment model within
a track) that meets the financial risk standard to be an Advanced APM
would be required to demonstrate that the percentage of eligible
clinicians in the ACO using CEHRT to document and communicate clinical
care to their patients or other health care providers meets or exceeds
the higher of 50 percent or the percentage specified in the CEHRT use
criterion for Advanced APMs at Sec. 414.1415(a)(1)(i). As a result, a
separate CEHRT use criterion for APMs under the Shared Savings Program
would no longer be necessary.
Therefore, we proposed to revise the separate Shared Savings
Program CEHRT use criterion at Sec. 414.1415(a)(1)(ii) so that it
would apply only for QP Performance Periods under the Quality Payment
Program prior to 2019. We sought comment on this proposal.
Comment: Several commenters supported the continued recognition for
integration of Electronic Medical Records (EMRs) and the sharing of
health information between providers and suppliers.
Response: We thank the commenters for their support.
Comment: A majority of commenters supported our proposal to replace
ACO-

[[Page 59986]]

11--Use of Certified EHR Technology with a requirement that ACOs
certify regarding the percentage of eligible clinicians participating
in the ACO that use CEHRT to document and communicate clinical care to
their patients or other health care providers. In addition, many
commenters urged CMS to clarify that MIPS eligible clinician
participating in Shared Savings Program ACOs would not be required to
report Promoting Interoperability (PI) and would instead see PI
performance category weights redistributed equally to the Quality and
Improvement Activities performance categories.
Response: As noted in the August 2018 proposed rule (83 FR 41909),
the proposal to replace ACO-11: Use of Certified EHR Technology with a
requirement that ACOs certify regarding the level of CEHRT use by
eligible clinicians in the ACO would not affect any previously
finalized requirements for MIPS eligible clinicians reporting on the PI
performance category under MIPS. MIPS eligible clinicians who are
participating in ACO tracks that are not Advanced APMs and/or who are
not QPs would continue to report as usual on the PI performance
category.
Comment: Several commenters asked CMS to clarify the proposals for
Promoting Interoperability in the August 2018 proposed rule, in the
final rule. Specifically, the commenters requested clarification on
when complete implementation of the 2015 CEHRT edition was required for
ACOs participating in the Shared Savings Program, as the proposal
discussed in the August 2018 proposed rule would require an ACO to
attest to the percentage of eligible clinicians utilizing CEHRT at the
time of application and annually thereafter. The commenters stated that
a requirement that they attest to meeting the CEHRT use threshold at
the time of application would negatively impact ACOs whose participants
make CEHRT decisions (such as upgrades) based on a minimum consecutive
90-day reporting period as set forth by the Quality Payment Program The
commenters stated that clarification of the deadline for implementation
was needed so healthcare organizations could have a clear understanding
of the expectations, allowing them to plan accordingly, especially for
those organizations that participate in more than one regulatory
program. In addition, several commenters requested that CMS clarify its
operational expectations with respect to the proposed new certification
requirement, so that ACOs can confirm that they are able to confidently
certify with respect to the level of CEHRT use in their ACO.
Response: We understand that ACOs need to know the deadline by
which they must meet the proposed new requirements regarding the use of
CEHRT and have an understanding of how they would be required to
demonstrate that they have met the requirement. As we explained in the
August 2018 proposed rule, we believe it is appropriate to ensure that
ACOs new to participation in the Shared Savings Program not be excluded
from the program due to a requirement that a high percentage of
eligible clinicians participating in the ACO use CEHRT. At the same
time, however, we also sought to align with the CEHRT use requirements
under the Quality Payment Program to ensure that eligible clinicians in
ACOs further along the risk continuum would have the opportunity to
participate in an Advanced APM for purposes of the Quality Payment
Program. While our proposal was intended to require that ACOs achieve
the applicable CEHRT use threshold starting in the 2019 performance
year, we understand from commenters that the requirement that ACOs
certify that the percentage of eligible clinicians in the ACO that use
CEHRT meets the applicable threshold at time of application could pose
an operational challenge. For example, a commenter stated that, ACOs
not yet operating on 2015 edition CEHRT may have implementation and
cost barriers related to the upgrade of CEHRT that may place them in a
non-complaint situation, given the short timeframe between the
publication of the final rule and the start of performance year 2019.
Based on the comments received in response to the proposals in the
August 2018 proposed rule and our desire to align with the Quality
Payment Program, under which eligible clinicians must certify regarding
their CEHRT use by the last day of the reporting period, we are not
finalizing our proposal to require ACOs to certify at the time of
application that they meet the applicable CEHRT requirements. However,
we are finalizing our proposal to require ACOs to certify annually that
the percentage of eligible clinicians participating in the ACO that use
CEHRT to document and communicate clinical care to their patients or
other health care providers meets or exceeds the applicable percentage
during the current performance year. ACOs will be required to submit
this certification in the form and manner specified by CMS for
performance years starting on January 1, 2019, and all subsequent
performance years. For performance years starting on January 1, 2019,
the annual certification will occur in the spring of 2019 for ACOs
extending their participation agreement for 6 months, and in the fall
of 2019 for ACOs that have a 12-month performance year during 2019. We
believe this final policy is not only responsive to commenters'
concerns regarding the timing of the certification but also enables
timely implementation of the requirement starting in 2019. As noted
above, a majority of commenters supported our proposal to replace ACO-
11--Use of Certified EHR Technology with a requirement that ACOs
certify regarding the percentage of eligible clinicians participating
in the ACO that use CEHRT to document and communicate clinical care to
their patients or other health care providers starting January 1, 2019.
We also note that this new requirement aligns more closely with the
requirements regarding CEHRT use imposed under the Next Generation ACO
Model, which requires that participating ACOs certify compliance with
the CEHRT use requirement in the fall of each performance year. As
stated in the August 2018 proposed rule, we currently require that ACOs
must have in place at the time of application a written plan to use
enabling technologies, such as electronic health records and other
health IT tools, to coordinate care (Sec. 425.112(b)(4)(i)(C)).
Because this policy is already in place, we believe that our decision
not to finalize the proposal to require ACOs to certify with respect to
their use of CEHRT at time of application to the Shared Savings Program
will not undermine the policies under the program designated to promote
and encourage the use of CEHRT.
Although the comments requesting clarification of our CEHRT
proposals were not specific regarding the Shared Savings Program track
for which they were seeking clarification, in this final rule we are
clarifying the CEHRT threshold requirement for ACOs participating in an
Advanced APM. Our intent at the time we proposed this policy was to
preserve a minimum threshold of 50 percent CEHRT use for all ACOs in
the Shared Savings Program, even if the requirement at Sec.
414.1415(a)(1)(i) were revised through future rulemaking to be below 50
percent. However, we now recognize that this proposed ``higher of''
policy generated undue complexity. In the unlikely event that the
requirement for CEHRT use at Sec. 414.1415(a)(1)(i) were to be reduced
to below 50 percent in the future, we would have the opportunity

[[Page 59987]]

to revisit the Shared Savings Program threshold through future
rulemaking. Accordingly, we are revising the proposed regulation at
Sec. 425.506(f)(2) to remove the reference to the 50 percent threshold
and to indicate that ACOs participating in a Shared Savings Program
track that meets the financial risk standard to be an Advanced APM,
would be required to demonstrate that the percentage of eligible
clinicians in the ACO using CEHRT to document and communicate clinical
care to their patients or other health care providers meets or exceeds
the percentage specified in the CEHRT use criterion for Advanced APMs
under Sec. 414.1415(a)(1)(i).
Comment: Several commenters suggested modifications to CMS'
proposal to require ACOs to certify that the percentage of eligible
clinicians in the ACO using CEHRT meets the applicable threshold.
Several commenters suggested that CMS delay the implementation of the
certification requirement attestation until performance year 2020 to
avoid inadvertently penalizing Track 1 ACOs that may not have
sufficient time to meet the new CEHRT requirement. Several other
commenters expressed concern that meeting the 50 percent CEHRT
threshold would be a hardship for ACOs in Track 1, especially ACOs
composed of independent physician practices and rural practices. These
commenters recommended that CMS not finalize this this new requirement,
but if CMS were to finalize the 50 percent threshold, these commenters
believed that CMS should extend exemptions to low-revenue ACOs or those
ACOs in which the plurality of eligible clinicians qualify for a
hardship exemption from the Promoting Interoperability performance
category under the MIPS. Another commenter suggested that CMS require
ACOs in a track (or payment model within a track) that meets the
financial risk standard to be an Advanced APM to meet the 50 percent
CEHRT requirement in the first performance year and then increase to 75
percent in the second performance year.
Response: We disagree with the suggestions that we delay
implementation of the proposed new CEHRT use requirement or impose
differential requirements for ACOs, depending on their performance year
or other attributes. Since the inception of the Shared Savings Program
in 2012, we have assessed the level of CEHRT use by certain clinicians
in ACOs (ACO-11: Use of Certified EHR Technology) as part of the
quality reporting requirements for each performance year. In the CY
2017 PFS final rule, we revised the ACO-11 measure to assess ACOs on
the degree of CEHRT use by eligible clinicians participating in the ACO
in order to align with the Quality Payment Program. Starting in 2017,
performance on this measure has been determined by calculating the
percentage of eligible clinicians participating in the ACO who
successfully meet the Promoting Interoperability Category Base Score.
We believe that this experience offers a foundation on which ACOs can
build and create processes that allow them to determine the percentage
of eligible clinicians participating in the ACO that use CEHRT during
an applicable performance year. As noted in the August 2018 proposed
rule (83 FR 41909 through 41910), average ACO performance on ACO-11:
Use of Certified EHR Technology has substantially exceeded 50 percent,
with ACOs reporting that on average roughly 80 percent of primary care
physicians in their ACOs meet meaningful use requirements.\39\ As a
result, we do not believe it is unreasonable to expect Track 1 ACOs to
meet the requirement that 50 percent or more of the eligible clinicians
participating in the ACO use CEHRT beginning in the performance year
starting on January 1, 2019. Furthermore, as noted above, our proposal
to require ACOs to certify that they meet the applicable CEHRT
threshold has no impact on the previously-finalized policy that MIPS
eligible clinicians participating in ACOs will continue to report on
the PI performance category. Under this policy, MIPS-eligible
clinicians are required to use the 2015 version of CEHRT for purposes
of reporting the promoting interoperability performance category (Sec.
414.1305). Accordingly, we believe our proposal to require this version
to be used by eligible clinicians participating in Shared Savings
Program ACOs aligns with existing requirements under the MIPS and does
not impose a new requirement on ACOs. Further, we believe our decision
not to finalize the requirement that ACOs certify with respect their
level of CEHRT use as part of the application process, and to implement
the requirement solely through the annual certification during the
performance year, will allow additional time for ACOs to update any
internal processes as needed in order to meet this requirement during
the performance year starting on January 1, 2019. In addition, as noted
above, over the years successful ACOs have provided feedback that it is
important to ``hit the ground running'' on their first day of
participation in the Shared Savings Program, rather than spending
several years developing their care processes. Based on this feedback,
as well as commenters who supported the CEHRT proposal, we believe it
is important to implement the proposed CEHRT use thresholds starting
January 1, 2019. We believe that the use of these thresholds to assess
CEHRT use by ACOs participating in the Shared Savings Program aligns
with existing requirements under the program and encourages
participation by organizations that are more likely to meet the program
goals.
---------------------------------------------------------------------------

\39\ This estimate is based on calculations of CEHRT use by
primary care physicians prior to the changes made to ACO-11 to align
with the Quality Payment Program, which became effective for quality
reporting for performance year 2017.
---------------------------------------------------------------------------

We received no comments on our proposals to change the regulation
at Sec. 425.204(c) to establish the new application requirement and
the regulation at Sec. 425.302(a)(3)(iii) to establish the new annual
certification requirement. We also received no comments on our proposal
to amend Sec. 425.20 to incorporate a definition of ``CEHRT''
consistent with the definition at Sec. 414.1305, including any
subsequent updates or revisions to that definition, and to incorporate
the definition of ``eligible clinician'' at Sec. 414.1305 that applies
under the Quality Payment Program. In addition, we received no comments
on our proposal to amend the separate Shared Savings Program CEHRT use
criterion at Sec. 414.1415(a)(1)(ii) so that it applies only for QP
Performance Periods under the Quality Payment Program prior to 2019.
Furthermore, we received no comments on our proposal to add a new
provision to the regulation at Sec. 425.506 to establish the CEHRT
requirement for performance years starting on January 1, 2019, and
subsequent performance years for ACOs in a track or payment model
within a track that does not meet the financial risk standard to be an
Advanced APM and ACOs in a track or payment model within a track that
meets the financial risk standard to be an Advanced APM.
After considering the comments received, we are finalizing with
modification our proposal that for performance years starting on
January 1, 2019, and subsequent performance years, ACOs in a track that
does not meet the financial risk standard to be an Advanced APM must
certify that at least 50 percent of the eligible clinicians
participating in the ACO use CEHRT to document and communicate clinical
care to their patients or other health care providers. Specifically, we
are finalizing

[[Page 59988]]

the requirement that ACOs make this certification annually in the form
and manner specified by CMS, but, for the reasons discussed above, we
are not finalizing the proposal to require ACOs to make this
certification at the time of application. Accordingly, for performance
years starting on January 1, 2019, and subsequent performance years,
ACOs in a track that does not meet the financial risk standard to be an
Advanced APM must certify annually that at least 50 percent of the
eligible clinicians participating in the ACO use CEHRT to document and
communicate clinical care to their patients or other health care
providers. We reiterate that this final policy does not affect the
previously finalized requirements for MIPS eligible clinicians
reporting on the Promoting Interoperability (PI) performance category
under MIPS. Accordingly, MIPS eligible clinicians who are participating
in ACOs under a payment track that is not an Advanced APM and/or who
are not QPs would continue to report as usual on the Promoting
Interoperability performance category.
Similarly, after considering the comments received, we are also
finalizing with modification our proposal with respect to ACOs in
Shared Savings Program tracks that meet the financial risk standard to
be an Advanced APM. We proposed that these ACOs would be required to
certify at the time of application and annually thereafter that they
meet the higher of the 50 percent threshold proposed for ACOs in a
track that does not meet the financial risk to be an advanced APM or
the CEHRT use criterion for Advanced APMs under the Quality Payment
Program at Sec. 414.1415(a)(1)(i).
For the reasons discussed previously, we not finalizing the
requirement that ACOs certify that they meet the higher of the 50
percent threshold or the applicable threshold under the Quality Payment
Program. Rather, ACOs will be required to certify only that they meet
the applicable threshold established under the Quality Payment Program.
In addition, as also discussed, we are not finalizing our proposal that
ACOs certify that they meet the CEHRT requirement at the time of
application. Accordingly, for performance years starting on January 1,
2019, and subsequent years, ACOs in a track that meets the financial
risk standard to be an Advanced APM must certify annually that the
percentage of eligible clinicians participating in the ACO that use
CEHRT to document and communicate clinical care to their patients or
other health care providers meets or exceeds the threshold established
under the Quality Payment Program at Sec. 414.1415(a)(1)(i).
We are finalizing the proposed new provision at Sec. 425.506(f)
with conforming modifications to reflect the policies we are finalizing
in this final rule. As part of these modifications, we are omitting the
reference to ``a payment model within a track'' because we are not
addressing the proposal to create the BASIC track, with separate
payment models at Levels A through E, at this time. We anticipate
summarizing and responding to comments received on this proposal and
other proposals related to the participation options under the Shared
Savings Program in a forthcoming final rule. For the reasons discussed
previously in this section, we are not finalizing the proposed changes
to the regulation at Sec. 425.204(c) to establish the new application
requirement; but, we are finalizing the proposed changes to the
regulation at Sec. 425.302(a)(3)(iii) to establish the new annual
certification requirement. In addition, we are finalizing our proposed
amendments to Sec. 425.20 to incorporate a definition of ``CEHRT''
consistent with the definition at Sec. 414.1305, including any
subsequent updates or revisions to that definition, and to incorporate
the definition of ``eligible clinician'' at Sec. 414.1305 that applies
under the Quality Payment Program. We are also finalizing our proposal
to amend the separate Shared Savings Program CEHRT use criterion at
Sec. 414.1415(a)(1)(ii) so that it applies only for QP Performance
Periods under the Quality Payment Program prior to 2019.
As noted in the August 2018 proposed rule (83 FR 41910), CMS
reserves the right to monitor, assess, and/or audit an ACO's compliance
with respect to its certification of CEHRT use among its participating
eligible clinicians, consistent with Sec. Sec. 425.314 and 425.316,
and to take compliance actions (including warning letters, corrective
action plans, and termination) as set forth at Sec. Sec. 425.216 and
425.218 when ACOs fail to meet or exceed the required CEHRT use
thresholds.
Finally, after considering the comments received in response to the
proposal to remove ACO-11: Use of Certified EHR Technology measure from
the Shared Savings Program quality measure set, we are finalizing our
proposal effective with quality reporting for performance years
starting on January 1, 2019, and subsequent performance years. We are
also finalizing the corresponding revisions to the regulation at Sec.
425.506 to reflect this change.
3. Applicability of Final Policies to Track 1+ Model ACOs
a. Background
In the August 2018 proposed rule (83 FR 41912), we discussed the
applicability of proposed policies to Track 1+ Model ACOs. We explained
that the Track 1+ Model was established under the Innovation Center's
authority at section 1115A of the Act, to test innovative payment and
service delivery models to reduce program expenditures while preserving
or enhancing the quality of care for Medicare, Medicaid, and Children's
Health Insurance Program beneficiaries. We noted that 55 Shared Savings
Program Track 1 ACOs entered into the Track 1+ Model beginning on
January 1, 2018. This includes 35 ACOs that entered the model within
their current agreement period (to complete the remainder of their
agreement period under the model) and 20 ACOs that entered into a new
3-year agreement period under the model.
To enter the Track 1+ Model, ACOs must be approved to participate
in the model and are required to agree to the terms and conditions of
the model by executing a Track 1+ Model Participation Agreement
available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/Downloads/track-1plus-model-par-agreement.pdf. Track 1+ Model ACOs are also required to have been
approved to participate in the Shared Savings Program (Track 1) and to
have executed a Shared Savings Program Participation Agreement. As
indicated in the Track 1+ Model Participation Agreement, in accordance
with its authority under section 1115A(d)(1) of the Act, CMS has waived
certain provisions of law that otherwise would be applicable to ACOs
participating in Track 1 of the Shared Savings Program, as necessary
for purposes of testing the Track 1+ Model, and established alternative
requirements for the ACOs participating in the Track 1+ Model.
We explained that, unless stated otherwise in the Track 1+ Model
Participation Agreement, the requirements of the Shared Savings Program
under 42 CFR part 425 continue to apply. Consistent with Sec. 425.212,
Track 1+ Model ACOs are subject to all applicable regulatory changes,
including but not limited to changes to the regulatory provisions
referenced within the Track 1+ Model Participation Agreement, that
become effective during the term of the ACO's Shared Savings Program
Participation Agreement and Track 1+ Model

[[Page 59989]]

Participation Agreement, unless otherwise specified through rulemaking
or amendment to the Track 1+ Model Participation Agreement. We noted
that the terms of the Track 1+ Model Participation Agreement permit the
parties (CMS and the ACO) to amend the agreement at any time by mutual
written agreement.
b. Unavailability of Application Cycles for Entry Into the Track 1+
Model in 2019
In the August 2018 proposed rule (83 FR 41912 through 41913), we
discussed the unavailability of application cycles for entry into the
Track 1+ Model in 2019 and 2020. We explained that an ACO's opportunity
to join the Track 1+ Model aligns with the Shared Savings Program's
application cycle. The original design of the Track 1+ Model included 3
application cycles for ACOs to apply to enter or, if eligible and if
applicable, to renew their participation in the Track 1+ Model for an
agreement period start date of 2018, 2019, or 2020. The 2018
application cycle is closed, and as discussed elsewhere in the August
2018 proposed rule, 55 ACOs began participating in the Track 1+ Model
on January 1, 2018. As discussed in section II.A.7 of the August 2018
proposed rule (83 FR 41847) and section V.B.1.a of this final rule, we
are not offering an application cycle for a January 1, 2019 start date
for new agreement periods under the Shared Savings Program. Therefore,
we similarly are not offering a start date of January 1, 2019, for
participation in the Track 1+ Model.
We explained that existing Track 1+ Model ACOs would be able to
complete the remainder of their current agreement period in the model.
Additionally, as discussed in section II.A.7.c.(1) of the August 2018
proposed rule (83 FR 41854 through 41855) and section V.B.1.c.(1) of
this final rule, ACOs currently participating in the Track 1+ Model
will not have the opportunity to apply to use a SNF 3-day rule waiver
starting on January 1, 2019, under our decision to forgo an annual
application cycle for a January 1, 2019 start date in the Shared
Savings Program. We proposed that, if finalized, the next available
application cycle for a SNF 3-day rule waiver would occur in advance of
a July 1, 2019 start date. We will address proposals related to future
application cycles in subsequent rulemaking.
c. Applicability of Proposed Policies to Track 1+ Model ACOs Through
Revised Program Regulations or Revisions to Track 1+ Model
Participation Agreements
In section II.F of the August 2018 proposed rule (83 FR 41913
through 41914), we provided a comprehensive discussion of the
applicability of the proposed policies to Track 1+ Model ACOs to allow
these ACOs to better prepare for their future years of participation in
the program and the Track 1+ Model. We explained that there are two
ways in which the proposed policies would become applicable to Track 1+
Model ACOs: (1) Through revisions to existing regulations that
currently apply to Track 1+ Model ACOs; and (2) through revisions to
the ACO's Track 1+ Model Participation Agreement.
We sought comment on these considerations, and any other issues
that we may not have discussed related to the effect of the proposed
policies on ACOs that entered the Track 1+ Model beginning in 2018. We
note that these ACOs will complete their participation in the Track 1+
Model by no later than December 31, 2020 (for ACOs that entered the
model at the start of a 3-year agreement period), or sooner in the case
of ACOs that entered the model at the start of their second or third
performance year within their current 3-year agreement period.
Generally, comments regarding the application of specific proposals
to Track 1+ Model ACOs have been addressed as part of the discussion of
comments in the relevant section of this final rule. Accordingly, in
this section of this final rule, we are not repeating comments related
to the applicability of the proposed policies to ACOs participating in
the Track 1+ Model.
Therefore, unless specified otherwise, the changes to the program's
regulations finalized in this final rule that are applicable to Shared
Savings Program ACOs within a current agreement period will apply to
ACOs in the Track 1+ Model in the same way that they apply to ACOs in
Track 1, so long as the applicable regulation has not been waived under
the Track 1+ Model. Similarly, to the extent that certain requirements
of the regulations that apply to ACOs under Track 2 or Track 3 have
been incorporated for ACOs in the Track 1+ Model under the terms of the
Track 1+ Model Participation Agreement, changes to the regulations as
finalized in this final rule will also apply to ACOs in the Track 1+
Model in the same way that they apply to ACOs in Track 2 or Track 3.
For example, the following policies apply to Track 1+ Model ACOs:
Revisions to voluntary alignment policies (section
V.B.2.b. of this final rule), applicable for the performance year
beginning on January 1, 2019, and subsequent performance years.
Revisions to the definition of primary care services used
in beneficiary assignment (section V.B.2.c. of this final rule),
applicable for the performance year beginning on January 1, 2019, and
subsequent performance years.
Discontinuation of quality measure ACO-11; requirement to
attest as part of the annual certification that a specified percentage
of the ACO's eligible clinicians use CEHRT (section V.B.2.f. of this
final rule), applicable for the performance year beginning on January
1, 2019, and subsequent performance years.
We will also apply the following policies finalized in this final
rule to Track 1+ Model ACOs through an amendment to the Track 1+ Model
Participation Agreement executed by CMS and the ACO:
Annual certification that the percentage of eligible
clinicians participating in the ACO that use CEHRT to document and
communicate clinical care to their patients or other health care
providers meets or exceeds the threshold established under Sec.
414.1415(a)(1)(i) (section V.B.2.f. of this final rule). This
certification is required to ensure the Track 1+ Model continues to
meet the CEHRT criterion to qualify as an Advanced APM for purposes of
the Quality Payment Program.
For ACOs that started a first or second Shared Savings
Program participation agreement on January 1, 2016, and entered the
Track 1+ Model on January 1, 2018, and that elect to extend their
Shared Savings Program participation agreement for the 6-month
performance year from January 1, 2019 through June 30, 2019 (as
described in section V.B.1 of this final rule):
++ As described in section V.B.1.c.(3) of this final rule, the ACO
should extend its repayment mechanism so that it remains in effect for
24 months after the end of the agreement period (June 30, 2021).
++ As described in section V.B.1.c.(10) of this final rule, the ACO
is eligible for shared savings if the following conditions are met: The
ACO completed the 6-month performance year starting on January 1, 2019;
the ACO has completed all close-out procedures specified in Sec.
425.221(a) by the deadline specified by CMS (if applicable); and the
ACO has satisfied

[[Page 59990]]

the criteria for sharing in savings for the performance year.
++ We will determine performance for the 6-month performance year
from January 1, 2019 through June 30, 2019, according to the approach
specified in a new section of the regulations at Sec. 425.609(b),
applying the financial methodology for calculating shared losses
specified in the ACO's Track 1+ Model Participation Agreement.
++ We will continue to share aggregate report data with the ACO for
the entire CY 2019, consistent with the approach described in section
V.B.1.c.(8) of this final rule, and the terms of the ACO's Track 1+
Model Participation Agreement.
Extreme and uncontrollable circumstances policies for
determining shared losses for performance years 2018 and subsequent
years, consistent with the policies specified in Sec. 425.610(i)
(section V.B.2.d. of this final rule) and, for ACOs that elect to
extend their Shared Savings Program participation agreement for the 6-
month performance year from January 1, 2019 through June 30, 2019, in
Sec. 425.609(d) (section V.B.1.c.(5) of this final rule).

VI. Collection of Information Requirements

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. chapter
35), we are required to publish a 30-day notice in the Federal Register
and solicit public comment before a collection of information
requirement is submitted to the Office of Management and Budget (OMB)
for review and approval.
We solicited comments in the notice of proposed rulemaking that
published in the July 27, 2018 Federal Register (83 FR 35704). For the
purpose of transparency, we are republishing the discussion of the
information collection requirements along with a reconciliation of the
public comments we received.

A. Wages

To derive average costs, we used data from the U.S. Bureau of Labor
Statistics' May 2017 National Occupational Employment and Wage
Estimates for all salary estimates (https://www.bls.gov/oes/current/oes_nat.htm). In this regard, Table 60 presents the mean hourly wage,
the cost of fringe benefits and overhead (calculated at 100 percent of
salary), and the adjusted hourly wage.
Private Sector Wages: The adjusted hourly wage is used to calculate
the labor costs associated with our finalized requirements.

Table 60--National Occupational Employment and Wage Estimates
----------------------------------------------------------------------------------------------------------------
Fringe
Occupation Mean hourly benefits and Adjusted
Occupation title code wage ($/hr) overhead costs hourly wage ($/
($/hr) hr)
----------------------------------------------------------------------------------------------------------------
All Occupations (for Individuals' Wages)........ 00-0000 24.34 n/a n/a
Billing and Posting Clerks...................... 43-3021 18.49 18.49 36.98
Computer Systems Analysts....................... 15-1121 44.59 44.59 89.18
Family and General Practitioner................. 29-1062 100.27 100.27 200.54
Licensed Practical Nurse (LPN).................. 29-2061 21.98 21.98 43.96
Medical Assistant............................... 31-9092 16.15 16.15 32.30
Medical Secretary............................... 43-6013 17.25 17.25 34.50
Physicians...................................... 29-1060 103.22 103.22 206.44
Practice Administrator (Medical and Health 11-9111 53.69 53.69 107.38
Services Managers).............................
Registered Nurse................................ 29-1141 35.36 35.36 70.72
----------------------------------------------------------------------------------------------------------------

As indicated, we adjusted our employee hourly wage estimates by a
factor of 100 percent. This is necessarily a rough adjustment, both
because fringe benefits and overhead costs vary significantly from
employer to employer, and because methods of estimating these costs
vary widely from study to study. Nonetheless, we believe that doubling
the hourly wage to estimate total cost is a reasonably accurate
estimation method.
Wages for Individuals: For beneficiaries who elect to complete the
CAHPS for MIPS survey, we believe that the burden will be addressed
under All Occupations (see Table 60) at $24.34/hr since the group of
individual respondents varies widely from working and nonworking
individuals and by respondent age, location, years of employment, and
educational attainment, etc. Unlike our private sector adjustment to
the respondent hourly wage, we did not adjust this figure for fringe
benefits and overhead since the individuals' activities will occur
outside the scope of their employment.

B. Information Collection Requirements (ICRs)

1. ICRs Regarding the Clinical Laboratory Fee Schedule (CLFS) (Section
III.A. of This Final Rule)
Section 1834A of the Act, as established by section 216(a) of the
Protecting Access to Medicare Act of 2014 (PAMA), required significant
changes to how Medicare pays for clinical diagnostic laboratory test
(CDLTs) under the CLFS. The CLFS final rule, titled ``Medicare Clinical
Diagnostic Laboratory Tests Payment System Final Rule'' (CLFS final
rule), was published in the Federal Register on June 23, 2016, and
implemented section 1834A of the Act. Under that rule (81 FR 41036),
``reporting entities'' must report to CMS during a ``data reporting
period'' ``applicable information'' (that is, certain private payor
data) collected during a ``data collection period'' for their component
``applicable laboratories.'' In general, the payment amount for each
CDLT on the CLFS furnished beginning January 1, 2018, is based on the
applicable information collected during the 6-month data collection
period and reported to us during the 3-month data reporting period, and
is equal to the weighted median of the private payor rates for the
CDLT.
An applicable laboratory is defined at Sec. 414.502, in part, as
an entity that is a laboratory (as defined under the Clinical
Laboratory Improvement Amendments (CLIA) definition at Sec. 493.2)
that bills Medicare Part B under its own National Provider Identifier
(NPI). In addition, an applicable laboratory is an entity that receives
more than 50 percent of its Medicare revenues during a data collection
period from the CLFS and/or the PFS. We refer to this component of the
applicable laboratory definition as the ``majority of Medicare revenues
threshold.'' The definition of applicable laboratory also includes a
``low expenditure threshold'' component, which requires an entity to
receive at least $12,500 of its Medicare revenues

[[Page 59991]]

from the CLFS during a data collection period for its CDLTs that are
not advanced diagnostic laboratory tests (ADLTs).
In determining payment rates under the private payor rate-based
CLFS, one of our goals is to obtain as much applicable information as
possible from the broadest possible representation of the national
laboratory market on which to base CLFS payment amounts, for example,
from independent laboratories, hospital outreach laboratories, and
physician office laboratories, without imposing undue burden on those
entities. We believe it is important to achieve a balance between
collecting sufficient data to calculate a weighted median that
appropriately reflects the private market rate for a CDLT, and
minimizing the reporting burden for entities. In response to
stakeholder feedback in the proposed rule (see section III.A.3 of this
final rule for a discussion of this feedback) and in the interest of
facilitating our goal, we are finalizing the revision to the majority
of Medicare revenues threshold component of the definition of
applicable laboratory at Sec. 414.502(3) to exclude Medicare Advantage
(MA) payments under Medicare Part C from the definition of total
Medicare revenues (that is, the denominator of the majority of Medicare
threshold equation). Specifically, this revision could allow additional
laboratories of all types serving a significant population of
beneficiaries enrolled in Medicare Part C to meet the majority of
Medicare revenues threshold and potentially qualify as applicable
laboratories (provided they meet all other requirements for applicable
laboratory status) and report data to us.
In addition, in response to stakeholder feedback (see section
III.A.4 of this final rule for a discussion of this feedback) in
response to the comment solicitation in the proposed rule and in the
interest of obtaining as much applicable information as possible, we
are finalizing a revision to the definition of applicable laboratory at
Sec. 414.502 to include a hospital that bills Medicare on the Form
CMS-1450 14x Type of Bill (OMB control number: 0938-0997) and its
electronic equivalent.
As such, we believe the finalized changes may result in more
applicable information being reported, which we will use to set CLFS
payment rates. However, with regard to the CLFS-related requirements
and burden, as we noted in the proposed rule, section 1834A(h)(2) of
the Act provides that the Paperwork Reduction Act in chapter 35 of
title 44 of the U.S.C. shall not apply to information collected under
section 1834A of the Act (which is the new private payor rate-based
CLFS).
For a complete discussion of our finalized revisions to the
definition of applicable laboratory in Sec. 414.502 related to the
majority of Medicare revenues threshold and use of the Form CMS-1450
14X TOB, we refer readers to sections III.A.4.a of this final rule.
2. ICRs Regarding Appropriate Use Criteria (AUC) for Advanced
Diagnostic Imaging Services (Sec. 414.94 and Section III.D. of this
final rule)
Consultations: In the CY19 PFS proposed rule, we proposed to revise
Sec. 414.94(j) to allow the AUC consultation, when not performed
personally by the ordering professional, to be performed by auxiliary
personnel (as defined in Sec. 410.26(a)(1)) under the direction of,
and incident to, the ordering professional's services. In this final
rule, we did not finalize this proposal but, instead, revised the
regulation to specify that clinical staff acting under the direction of
the ordering professional may perform the AUC consultation. The revised
AUC consultation requirements and burden will be submitted to OMB for
approval under control number 0938-1345 (CMS-10654).
General practitioners make up a large group of practitioners who
order applicable imaging services and will be required to consult AUC
under this program so we use ``family and general practitioner'' from
the list of BLS occupation titles (see Table 60) to calculate the
following cost estimates. While we proposed to modify the consultation
requirement to allow auxiliary personnel, working under the direction
of the ordering professional, to interact with the CDSM for AUC
consultation, in this final rule we changed this estimate from using
the ``registered nurse'' occupation to using the ``medical assistant''
occupation to calculate our revised cost estimates for our final policy
to allow clinical staff acting under the direction of the ordering
professional to perform the AUC consultation.
To derive the burden associated with the requirements under Sec.
414.94(j), we estimate it will take 2 minutes (0.033 hr) at $70.72/hr
for auxiliary personnel in the form of a registered nurse to consult
with a qualified CDSM. The Medicare Benefit Policy Manual (Pub. 100-
02), Chapter 15, Section 60.2 IOM 100-02, requires that an incidental
service performed by the nonphysician practitioner must have followed
from a direct, personal, professional service furnished by the
physician. Therefore, to estimate the percentage of consultations
available to be performed incident to, we analyzed 2014 Medicare Part B
claims comparing evaluation and management visits for new (CPT codes
99201, 99202, 99203, 99204, and 99205) relative to established (CPT
codes 99211, 99212, 99213, 99214, 99215) patients with place of service
codes 11 (physician's office). We found that approximately 10 percent
of all claims incurred were for new patients. Therefore, we also
estimate that 90 percent or 38,863,636 of the total consultations
(43,181,818 total consultations x 0.90) will be performed by such
auxiliary personnel, with the remaining 10 percent (43,181,818 x 0.10)
performed by the ordering professional. In this final rule and after
review of public comments (see below), we revised Sec. 414.94(j) to
allow ordering professionals to delegate the AUC consultation to
clinical staff acting under the direction of the ordering professional.
To reflect this change, we updated our burden estimates to reflect the
final policy and revised our estimates to replace a registered nurse
with medical assistant to perform the AUC consultation. In aggregate,
we estimate an annual burden of 1,282,500 hours (38,863,636.2
consultations x 0.033 hr/consultation) at a cost of $41,424,750
(1,282,500 hr x $32.30/hr) or $1.07 per consultation performed by
clinical staff under the direction of the ordering professional. We
will continue to monitor our burden estimates and, if necessary, adjust
them for more precision once the program begins.
Additionally, the CY 2018 Physician Fee Schedule final rule (82 FR
52976) explicitly discussed and provided a voluntary period for
ordering professionals to begin to familiarize themselves with
qualified CDSMs. During the current 18-month voluntary participation
period, we estimate there may be 10,230,000 consultations based on
market research from current applicants for the qualification of their
CDSMs for advanced diagnostic imaging services. Based on feedback from
CDSMs with experience in AUC consultation, as well as standards
recommended by the Office of the National Coordinator (ONC) \40\ and
the Healthcare Information Management Systems Society (HIMSS),\41\ we
estimate it will take 2 minutes (0.033 hr) at $200.54/hr for a family
and general practitioner or 2 minutes at $32.30/hr for a medical
assistant to use a qualified CDSM to consult specified applicable

[[Page 59992]]

AUC. The inclusion of a medical assistant in this calculation is
reflective of our modifications in the final rule as discussed above.
As mentioned previously, we estimate that as many as 90-percent of
practices could use auxiliary personnel working under the direction of
the ordering professional to interact with the CDSM for AUC
consultation. Consequently, we estimate a total burden of 337,590 hours
(10,230,000 consultations x 0.033 hr) at a cost of $16,583,771
([337,590 hr x 0.10 x $200.54/hr] + [337,590 hr x 0.90 x $32.30/hr]).
Annually, we estimate 112,530 hours (337,590 hr/3 yr) at a cost of
$5,527,924 ($16,583,771/3 yr). We are annualizing the one-time burden
(by dividing our estimates by OMB's 3-year approval period) since we do
not anticipate any additional burden after the 18-month voluntary
participation period ends.
---------------------------------------------------------------------------

\40\ https://ecqi.healthit.gov/cds#quicktabs-tabs_cds3.
\41\ https://www.himss.org/improving-outcomes-cds-practical-pearls-new-himss-guidebook.
---------------------------------------------------------------------------

Beginning January 1, 2020, we anticipate 43,181,818 responses in
the form of consultations based on the aforementioned market research,
as well as Medicare claims data for advanced diagnostic imaging
services. As noted earlier, we estimate it will take 2 minutes (0.033
hr) at $200.54/hr for a family and general practitioner or 2 minutes at
$32.30/hr for a medical assistant to use a qualified CDSM to consult
specified applicable AUC. In aggregate, we estimate an annual burden of
1,425,000 hours (43,181,818 consultations x 0.033 hr/consultation) at a
cost of $70,001,700 ([0.1 x 1,425,000 hr x $200.54/hr] + [0.9 x
1,425,000 hr x $32.30/hr]).
Annual Reporting: Consistent with section 1834(q)(4)(B) of the Act,
we finalized at Sec. 414.94(k) the reporting requirement of AUC
consultation information and in the CY 2018 PFS final rule (82 FR
52976) we estimated the burden of implementing the one-time voluntary
reporting period beginning in July 2018, and will be implementing the
mandatory annual reporting requirement beginning January 1, 2020.
Specifically, Sec. 414.94(k) requires Medicare claims for advanced
diagnostic imaging services, paid for under an applicable payment
system (as defined in Sec. 414.94(b)) and ordered on or after January
1, 2020, to include the following information: (1) Which qualified CDSM
was consulted by the ordering professional; (2) whether the service
ordered would adhere to specified applicable AUC, would not adhere to
specified applicable AUC, or whether specified applicable AUC was not
applicable to the service ordered; and (3) the NPI of the ordering
professional (if different from the furnishing professional). The
reporting requirement will not have any impact on any Medicare claim
forms because the forms' currently approved data fields, instructions,
and burden are not expected to change. Consequently, there is no need
for review by OMB under the authority of the PRA; however, we have
assessed the impact and include an analysis to this effect in the
regulatory impact section of this final rule.
Significant Hardship Exception: We proposed and are finalizing
revisions to Sec. 414.94(i)(3) that provide for a significant hardship
exception for ordering professionals who experience a significant
hardship affecting their consultation of AUC when ordering an advanced
diagnostic imaging service. The revisions establish a process whereby
all ordering professionals can self-attest that they are experiencing a
significant hardship at the time of placing an advanced diagnostic
imaging order. Although this is not a certification being used as a
substitute for a collection of AUC consultation information because no
consultation is required by statute to take place, the significant
hardship exception process consists of appending to the order for an
applicable imaging service the significant hardship information for
inclusion on the Medicare claim in lieu of the AUC consultation
information. This imposes no burden beyond providing identifying
information and attesting to the applicable information. In this
regard, the use of this process is not ``information'' as defined under
5 CFR 1320.3(h), and therefore, is exempt from requirements of the PRA.
Recordkeeping: Section 1834(q)(4)(C) of the Act provides for
certain exceptions to the aforementioned AUC consultation requirement;
therefore we believe that some claims for advanced diagnostic imaging
services will not contain AUC consultation information, such as in the
case of an ordering professional with a significant hardship. However,
ordering professionals will store documentation supporting the self-
attestation of a significant hardship. Storage of this information
could involve the use of automated, electronic, or other forms of
information technology at the discretion of the ordering professional.
We estimate that the average time for office clerical activities
associated with this storage of information to be 10 minutes (0.167 hr)
at $34.50/hr for a medical secretary to perform 6,699 recordkeeping
actions, since consultation will not take place in the year when a
hardship is incurred and 2016 data from the Medicare EHR Incentive
Program and the first 2019 payment year MIPS eligibility and special
status file suggests this estimate of those seeking hardship (OMB
control number 0938-1314; CMS-10621). In aggregate we estimate an
annual burden of 1,119 hours (6,699 recordkeeping activities x 0.167
hr/activity) at a cost of $38,596 (0.167 hr/activity x 6,699
recordkeeping activities x $34.50/hr). We solicited comments to inform
these burden estimates.
The following is a summary of the comments we received regarding
these burden estimates.
Comment: Commenters questioned the assumptions in CMS's
calculations as part of the proposal to modify the AUC consultation
requirement to allow auxiliary personnel, working under the direction
of the ordering professional, to interact with the CDSM for AUC
consultation. These commenters suggested using the ``medical
assistant'' rather than the ``registered nurse'' occupation to
calculate our revised cost estimates.
Response: As stated in this rule, we have finalized a change in the
consulting requirement at 414.94(j) to allow ordering professionals to
delegate the consultation to clinical staff acting under the direction
of the ordering professional. In aggregate, we update our proposed
estimate of an annual burden of 1,282,500 hours at a cost of
$90,698,400 or $2.33 per consultation to an annual burden of 1,282,500
hours (38,863,636.2 consultations x 0.033 hr/consultation) at a cost of
$41,424,750 (1,282,500 hr x $32.30/hr) or $1.07 per consultation using
the medical assistant occupation code 31-9092 with mean hourly wage of
$16.15 and 100 percent fringe benefits.
Comment: A few commenters disagreed that the reporting requirement
will not have any impact on any Medicare claim forms. These commenters
observed that the electronic claim standard for the institutional
provider (837i) does not capture or have a placeholder for reporting
the ordering physician's NPI.
Response: We appreciate the opportunity to clarify our analysis and
the distinctions between reporting AUC consultation information and
standardized communications on Medicare claims forms. The X12N
insurance subcommittee develops and maintains standards for healthcare
administrative transactions on professional (837p), institutional
(837i), and dental (837d) transactions when submitting healthcare
claims for a service or encounter. The current mandated version of 837
transactions is 5010\TM\. While we have not finalized a process for
implementing the reporting requirements at Sec. 414.94(k), we clarify
that implementation of changes to the

[[Page 59993]]

claim form transactions would not take place outside of the existing
process we described.
After considering the comments, we are updating the proposed impact
estimate of consultations by ordering professionals. First, we modified
our calculation of the effort by a registered nurse to the effort of a
2-minute consultation with a qualified CDSM by a medical assistant
(occupation code 31-9092) with mean hourly wage of $16.15 and 100
percent fringe benefits for 90 percent of consultations (1,282,500
hours) to be $41,424,750 (1,282,500 hours x $32.30/hour). Consequently,
we have updated our estimated total burden during the voluntary period
to 337,590 hours (10,230,000 consultations x 0.033 hr) at a cost of
$16,583,771.16 ([337,590 hr x 0.10 x $200.54/hr] + [337,590 hr x 0.90 x
$32.30/hr]). Annually, this estimate represents 112,530 hours (337,590
hr/3 yr) at a cost of $5,527,923.72 ($16,583,771.16/3 yr).
Additionally, we update our aggregate estimate of annual burden
beginning January 1, 2020 of 1,425,000 hours (43,181,818 consultations
x 0.033 hr/consultation) at a cost of $70,001,700 ([0.1 x 1,425,000 hr
x $200.54/hr] + [0.9 x 1,425,000 hr x $32.30/hr]).
3. ICRs Regarding the Medicare Shared Savings Program (Part 425 and
Section III.F. of This Final Rule)
Section 1899(e) of the Act provides that chapter 35 of title 44 of
the U.S. Code, which includes such provisions as the PRA, shall not
apply to the Shared Savings Program.
4. ICRs Regarding the Physician Self-Referral Law (42 CFR Part 411 and
Section III.G. of This Final Rule)
Section 1877 of the Act, also known as the physician self-referral
law: (1) Prohibits a physician from making referrals for certain
designated health services (DHS) payable by Medicare to an entity with
which he or she (or an immediate family member) has a financial
relationship (ownership or compensation), unless an exception applies;
and (2) prohibits the entity from filing claims with Medicare (or
billing another individual, entity, or third party payer) for those
referred services. The statute establishes a number of specific
exceptions, and grants the Secretary the authority to create regulatory
exceptions for financial relationships that pose no risk of program or
patient abuse. Additionally, the statute mandates refunding any amount
collected under a bill for an item or service furnished under a
prohibited referral. Finally, the statute imposes reporting
requirements and provides for sanctions, including civil monetary
penalty provisions.
As discussed in section III.G. of this rule, we are finalizing
regulatory updates to implement section 50404 of the Bipartisan Budget
Act of 2018 (Pub. L. 115-123, enacted February 9, 2018), which added
provisions to section 1877(h)(1) of the Act pertaining to the writing
and signature requirements in certain compensation arrangement
exceptions to the physician self-referral law's referral and billing
prohibitions. Although we believe that the newly enacted provisions in
section 1877(h)(1) of the Act are principally intended merely to codify
in statute existing CMS policy and regulations with respect to
compliance with the writing and signature requirements, we are
finalizing revisions to our regulations at 42 CFR 411.354(e) and
411.353(g) to address any actual or perceived difference between the
statutory and regulatory language, to codify in regulation our
longstanding policy regarding satisfaction of the writing requirement
found in many of the exceptions to the physician self-referral law, and
to make the Bipartisan Budget Act of 2018 policies applicable to
compensation arrangement exceptions issued using the Secretary's
authority in section 1877(b)(4) of the Act. The burden associated with
the writing and signature requirements is the time and effort necessary
to prepare written documents and obtain signatures of the parties.
Although the writing and signature requirements are subject to the
PRA, we believe the associated burden is exempt under 5 CFR
1320.3(b)(2). We believe that the time, effort, and financial resources
necessary to comply with the writing and signature requirements will be
incurred by persons during the normal course of their activities and in
the absence of federal regulation. Specifically, we believe that, for
normal business operations purposes, health care providers and
suppliers document their financial arrangements with physicians and
others in order to identify and be able to enforce the legal
obligations of the parties. Therefore, we believe that the writing and
signature requirements should be considered usual and customary
business practices.
We did not receive any public comments regarding our position that
the burden associated with these requirements is a usual and customary
business practice that is exempt from the PRA.
5. The Quality Payment Program (Part 414 and Section III.I. of This
Final Rule)
Summary: For the PRA, the Quality Payment Program is comprised of a
series of ICRs associated with MIPS and Advanced APMs. The MIPS ICRs
consist of registration for virtual groups; qualified registry and QCDR
self-nomination; CAHPS survey vendor applications; Quality Payment
Program Identity Management Application Process; quality performance
category data submission by Medicare Part B claims collection type,
QCDR and MIPS CQM collection type, eCQM collection type, and CMS web
interface submission type; CAHPS for MIPS survey beneficiary
participation; group registration for CMS web interface; group
registration for CAHPS for MIPS survey; call for quality measures;
reweighting applications for Promoting Interoperability and other
performance categories; Promoting Interoperability performance category
data submission; call for Promoting Interoperability measures;
improvement activities performance category data submission; nomination
of improvement activities; and opt-out of Physician Compare for
voluntary participants. ICRs for Advanced APMs consist of Partial
Qualifying APM participant (QP) election; Other Payer Advanced APM
identification: Payer Initiated and Eligible Clinician Initiated
Processes; and submission of data for All-Payer QP determinations under
the All-Payer Combination Option.
The following ICRs reflect this final rule's policies, as well as
policies in the CY 2017 (81 FR 77008) and CY 2018 (82 FR 53568) Quality
Payment Program final rules. In discussing each ICR, we reference the
specific policies and whether they are finalized in this final rule or
finalized in the CY 2017 or CY 2018 Quality Payment Program final
rules. As described in this section in more detail, three ICRs
(Quality: CMS Web Interface, Promoting Interoperability Performance
Category: Data Submission, and Voluntary Participants Election to Opt-
Out of Performance Data Display on Physician Compare) show a reduction
in burden due to changes in policies that we are finalizing in this
final rule. Most of the burden estimates discussed in this section are
reductions in burden compared to currently approved estimates and
reflect adjustments due to the use of data from the 2017 MIPS
performance period or revised per-respondent burden assumptions.
Finally, we added one ICR to incorporate a collection previously
mentioned in the CY 2018 Quality

[[Page 59994]]

Payment Program final rule for which collection had not yet started:
Submission of Data for All-Payer QP Determinations (82 FR 53886). See
section V.B.5. of this final rule for a summary of the ICRs, the
overall burden estimates, changes in burden estimates due to policies
established in this final rule, and a summary of the policy and data
changes affecting each ICR.
The revised requirements and burden estimates for all Quality
Payment Program ICRs (except for CAHPS for MIPS and virtual groups
election) will be submitted to OMB for approval under control number
0938-1314 (CMS-10621). The revised CAHPS for MIPS ICRs will be
submitted to OMB for approval under control number 0938-1222 (CMS-
10450). The Virtual Groups Election is approved under OMB control
number 0938-1343 (CMS-10652).
With regard to Quality Payment Program respondents, we selected BLS
occupations Billing and Postal Clerks, Computer Systems Analysts,
Physicians, Practice Administrator, and Licensed Practical Nurse (see
Wage Estimates in section V.A. of this final rule) based on a study
(Casalino et al., 2016) that collected data on the staff in physician's
practices involved in the quality data submission process.\42\ To
calculate the cost for virtual groups to prepare their written formal
agreements, we used wage estimates for Legal Support Workers, All
Others.
---------------------------------------------------------------------------

\42\ Lawrence P. Casalino et al., ``US Physician Practices Spend
More than $15.4 Billion Annually to Report Quality Measures,''
Health Affairs, 35, no. 3 (2016): 401-406.
---------------------------------------------------------------------------

Respondent estimates for the quality, Promoting Interoperability,
and improvement activities performance categories are modeled using
data from the 2017 MIPS performance period with the sole exception of
286 CMS Web Interface respondents, which is based on the number of
groups who registered for using the CMS Web Interface during the 2018
MIPS performance period.
As discussed in section III.I.3.a. of this final rule, we are
finalizing with modification our proposal to expand MIPS to additional
clinician types starting with the 2019 MIPS performance period/2021
MIPS payment year; these new clinician types include physical
therapists, occupational therapists, qualified speech-language
pathologists, qualified audiologists, clinical psychologists, and
registered dieticians or nutrition professionals. In addition, in
section III.I.3.c. of this final rule, we are finalizing the low-volume
threshold in the following manner: If a MIPS eligible clinician meets
or exceeds one, but not all, of the low-volume threshold criterion,
including as defined by dollar amount ($90,000), beneficiary count
(200), or covered professional services to Part-B enrolled individuals
(minimum threshold of 200) then the clinician may elect to submit data
and opt-in to MIPS. If a MIPS eligible clinician does not meet at least
one of these low-volume determinations or meets at least one, but not
all, of these low-volume determinations and elects not to opt-in, the
clinician is not eligible and is excluded from MIPS. If the clinician
is excluded and submits data, the clinician will be a voluntary
reporter. These policies will expand the number of potential MIPS
eligible clinicians, but we do not anticipate an incremental increase
in the burden because the affected clinicians were assumed to be
voluntary reporters in prior rules. In the CY 2018 Quality Payment
Program final rule, clinicians who participated in 2016 PQRS, and who
were not determined to be QPs based on their participation in Advanced
APMs during CY 2017 and were not MIPS eligible, were assumed to be
voluntary reporters in MIPS (82 FR 53908) with their burden accounted
for within our estimates. Therefore, the finalized expansion in MIPS
eligibility does not change the total number of respondents, but
instead shifts a certain number of assumed voluntary reporters to MIPS
eligible clinicians. Additionally, clinicians or groups agreeing to
opt-in or voluntarily report will simply select the option of opt-in
participation or to remain excluded and voluntarily report prior to
submitting data; therefore, we do not believe a commensurate revision
to the burden hours is necessary for any of our burden estimates. We
realize that clinicians or groups in small practices who submit quality
data via Medicare Part B claims do not have to log in the Quality
Payment Program portal to submit data; however, we assume the
clinicians or groups electing to opt-in would also submit data for the
improvement activities performance category as well. Therefore, the
effort to elect to opt-in is included in the burden estimate for the
improvement activities performance category. We also note that third
party intermediaries can be authorized to communicate this opt-in on
behalf of clinicians.
Our participation estimates are reflected in Tables 64, 65, and 66
for the quality performance category, Table 77 for the Promoting
Interoperability performance category, and Table 79 for the improvement
activities performance category.
Due to data limitations, our burden estimates may overstate the
total burden for data submission under the quality, Promoting
Interoperability, and improvement activities performance categories.
This is due to two primary reasons. First, we anticipate the number of
QPs to increase because of total expected growth in Advanced APM
participation. The additional QPs will be excluded from MIPS and likely
not report. Second, it is difficult to predict what eligible clinicians
who may report voluntarily will do in the 2019 MIPS performance period
compared to the 2017 MIPS performance period and, therefore, the actual
number of participants and how they elect to submit data may be
different than our estimates. However, we believe our estimates are the
most appropriate given the available data.
The following is a summary of general public comments received
regarding our request for comment on our information collections and
our responses. We received several general comments regarding the
burden of data collection associated with the Quality Payment Program.
Comment: One commenter requested CMS provide a table in the
Collection of Information section of the final rule consistent with the
summary table provided in previous years' final rules which summarizes
annual recordkeeping and submission requirements as well as the total
burden estimate for the cost of reporting to the Quality Payment
Program. The commenter stated its belief that this information is
important for policymakers to consider the total cost of pay-for-
performance programs in light of the utility of the information
collected.
Response: We have provided total burden summary information by OMB
control number including the total burden estimate for the cost of
reporting to the Quality Payment Program in the table notes for Table
91. For more details, please refer to the Supporting Statement A of the
Paperwork Reduction Act package for each OMB control number.
Comment: One commenter noted that based on the burden estimates
provided in the proposed rule as well as the additional time spent
analyzing feedback data and implementing care improvements, clinicians
and their staff are spending too much time and money reporting data and
not enough time on patient care. Further, the commenter requested that
CMS continue finalizing policies that will reduce administrative burden
and make the Quality Payment

[[Page 59995]]

Program more cohesive, holistic, and simplified.
Response: We will continue refining the Quality Payment Program
with the goal of reducing administrative, operational, and reporting
burden while balancing the goal of improving quality of care.
After consideration of the public comments, we are not making any
changes to our burden estimate methodology, but have updated the burden
estimates to reflect the availability of participation data from the
2017 MIPS performance period.
Framework for Understanding the Burden of MIPS Data Submission:
Because of the wide range of information collection requirements under
MIPS, Table 61 presents a framework for understanding how the
organizations permitted or required to submit data on behalf of
clinicians vary across the types of data, and whether the clinician is
a MIPS eligible clinician or other eligible clinician voluntarily
submitting data, MIPS APM participant, or an Advanced APM participant.
As shown in the first row of Table 61, MIPS eligible clinicians that
are not in MIPS APMs and other clinicians voluntarily submitting data
will submit data either as individuals, groups, or virtual groups for
the quality, Promoting Interoperability, and improvement activities
performance categories. Note that virtual groups are subject to the
same data submission requirements as groups, and therefore, we will
refer only to groups for the remainder of this section unless otherwise
noted. Because MIPS eligible clinicians are not required to submit any
additional information for assessment under the cost performance
category, the administrative claims data used for the cost performance
category is not represented in Table 61.
For MIPS eligible clinicians participating in MIPS APMs, the
organizations submitting data on behalf of MIPS eligible clinicians
will vary between performance categories and, in some instances,
between MIPS APMs. For the 2019 MIPS performance period, the quality
data submitted by Shared Savings Program ACOs, Next Generation ACOs,
and other APM Entities on behalf of their participant MIPS eligible
clinicians will fulfill any MIPS submission requirements for the
quality performance category.
For the Promoting Interoperability performance category, group TINs
may submit data on behalf of eligible clinicians in MIPS APMs, or
eligible clinicians in MIPS APMs may submit data individually. For the
improvement activities performance category, we will assume no
reporting burden for MIPS APM participants. In the CY 2017 Quality
Payment Program final rule, we describe that for MIPS APMs, we compare
the requirements of the specific MIPS APM with the list of activities
in the Improvement Activities Inventory and score those activities in
the same manner that they are otherwise scored for MIPS eligible
clinicians (81 FR 77185). Although the policy allows for the submission
of additional improvement activities if a MIPS APM receives less than
the maximum improvement activities performance category score, to date
all MIPS APM have qualified for the maximum improvement activities
score. Therefore, we assume that no additional submission will be
needed.
Advanced APM participants who are determined to be Partial QPs may
incur additional burden if they elect to participate in MIPS, which is
discussed in more detail in the CY 2018 Quality Payment Program final
rule (82 FR 53841 through 53844), but other than the election to
participate in MIPS, we do not have data to estimate that burden.

Table 61--Clinicians or Organizations Submitting MIPS Data on Behalf of Clinicians, by Type of Data and Category
of Clinician *
----------------------------------------------------------------------------------------------------------------
Type of data submitted
--------------------------------------------------------------------------------
Other data
Category of clinician Quality Promoting Improvement submitted on
performance interoperability activities behalf of MIPS
category performance performance eligible
category category clinicians
----------------------------------------------------------------------------------------------------------------
MIPS Eligible Clinicians (not As group or As group or As group or Groups electing to
in MIPS APMs) and Other individual individual individual use a CMS-
Eligible Clinicians clinicians. clinicians. clinicians. approved survey
Voluntarily Submitting Data Clinicians who are vendor to
\a\. hospital-based, administer CAHPS
ambulatory must register.
surgical center- Groups electing
based, non-patient to submit via CMS
facing, physician Web Interface for
assistants, nurse the first time
practitioners, must register.
clinician nurse Virtual groups
specialists, must register via
certified email.
registered nurse
anesthetists,
physical
therapists,
occupational
therapists,
qualified speech-
language
pathologists,
qualified
audiologists,
clinical
psychologists, and
registered
dieticians or
nutrition
professionals are
automatically
eligible for a
zero percent
weighting for the
Promoting
Interoperability
performance
category.
Clinicians who
submit an
application and
are approved for
significant
hardship or other
exceptions are
also eligible for
a zero percent
weighting.

[[Page 59996]]

Eligible Clinicians ACOs submit to the Each MIPS eligible CMS will assign Advanced APM
participating in the Shared CMS Web Interface clinician in the the improvement Entities will
Savings Program or Next and CAHPS for APM Entity reports activities make election for
Generation ACO Model (both ACOs on behalf of data for the performance participating
MIPS APMs). their Promoting category score to MIPS eligible
participating Interoperability each APM Entity clinicians.
MIPS eligible performance group based on
clinicians. category through the activities
[These either group TIN involved in
submissions are or individual participation in
not included in reporting. [Burden the Shared
burden estimates estimates for this Savings
for this final final rule assume Program.\d\ The
rule because group TIN-level burden estimates
quality data reporting].\c\ for this final
submission to rule assume no
fulfill improvement
requirements of activity
the Shared reporting burden
Savings Program for APM
and for purposes participants
of testing and because we assume
evaluating the the MIPS APM
Next Generation model provides a
ACO Model are not maximum
subject to the improvement
PRA].\b\ activity
performance
category score.].
Eligible Clinicians APM Entities Each MIPS eligible CMS will assign Advanced APM
participating in Other MIPS submit to MIPS on clinician in the the same Entities will
APMs. behalf of their APM Entity reports improvement make election for
participating data for the activities participating
MIPS eligible Promoting performance eligible
clinicians. Interoperability category score to clinicians.
[These performance each APM Entity
submissions are category through based on the
not included in either group TIN activities
burden estimates or individual involved in
for this final reporting. [The participation in
rule because burden estimates the MIPS APM.
quality data for this final [The burden
submission for rule assume group estimates for
purposes of TIN-level this final rule
testing and reporting]. assume no
evaluating improvement
Innovation Center activities
models tested performance
under Section category
1115A of the reporting burden
Social Security for APM
Act (or Section participants
3021 of the because we assume
Affordable Care the MIPS APM
Act) are not model provides a
subject to the maximum
PRA]. improvement
activity score].
----------------------------------------------------------------------------------------------------------------
* Because the cost performance category relies on administrative claims data, MIPS eligible clinicians are not
required to provide any additional information, and therefore, the cost performance category is not
represented in this table.
\a\ Virtual group participation is limited to MIPS eligible clinicians, specifically, solo practitioners and
groups consisting of 10 eligible clinicians or fewer.
\b\ Sections 1899 and 1115A of the Act (42 U.S.C. 1395jjj and 42 U.S.C. 1315a, respectively) state the Shared
Savings Program and testing, evaluation, and expansion of Innovation Center models are not subject to the PRA.
\c\ Both group TIN and individual clinician Promoting Interoperability data will be accepted. If both group TIN
and individual scores are available for the same APM Entity, CMS will use the higher score for each TIN/NPI.
The TIN/NPI scores are then aggregated for purposes of calculating the APM Entity score.
\d\ APM Entities participating in MIPS APMs do not need to submit improvement activities data unless the CMS-
assigned improvement activities scores are below the maximum improvement activities score.

The policies finalized in the CY 2017 and the CY 2018 Quality
Payment Program final rules and this final rule create some additional
data collection requirements not listed in Table 61. These additional
data collections, some of which were previously approved by OMB under
the control numbers 0938-1314 (Quality Payment Program) and 0938-1222
(CAHPS for MIPS), are as follows:

Additional approved ICRs related to MIPS third-party intermediaries
Self-nomination of new and returning QCDRs (81 FR 77507
through 77508 and 82 FR 53906 through 53908) (OMB 0938-1314).
Self-nomination of new and returning registries (81 FR
77507 through 77508 and 82 FR 53906 through 53908) (OMB 0938-1314).
Approval process for new and returning CAHPS for MIPS
survey vendors (82 FR 53908) (OMB 0938-1222).

Additional ICRs related to the data submission and the quality
performance category
CAHPS for MIPS survey completion by beneficiaries (81 FR
77509 and 82 FR 53916 through 53917) (OMB 0938-1222).
Quality Payment Program Identity Management Application
Process (82 FR 53914).

Additional ICRs related to the Promoting Interoperability performance
category
Reweighting Applications for Promoting Interoperability
and other performance categories (82 FR 53918) (OMB 0938-1314).

Additional ICRs related to call for new MIPS measures and activities
Nomination of improvement activities (82 FR 53922) (OMB
0938-1314).

[[Page 59997]]

Call for new Promoting Interoperability measures (OMB
0938-1314).
Call for new quality measures (OMB 0938-1314).

Additional ICRs related to MIPS
Opt out of performance data display on Physician Compare
for voluntary reporters under MIPS (82 FR 53924 through 53925) (OMB
0938-1314).

Additional ICRs related to APMs
Partial QP Election (81 FR 77512 through 77513 and 82 FR
53922 through 53923) (OMB 0938-1314).
Other Payer Advanced APM determinations: Payer Initiated
Process (82 FR 53923 through 53924) (OMB 0938-1314).
Other Payer Advanced APM determinations: Eligible
Clinician Initiated Process (82 FR 53924) (OMB 0938-1314).
Submission of Data for All-Payer QP Determinations (New
data collection for the 2019 performance period) (OMB 0938-1314).
6. Quality Payment Program ICRs Regarding the Virtual Group Election
(Sec. 414.1315)
This final rule does not include any new or revised reporting,
recordkeeping, or third-party disclosure requirements related to the
virtual group election. The virtual group election requirements and
burden are currently approved by OMB under control number 0938-1343
(CMS-10652). Consequently, we have not made any virtual group election
changes under that control number.
7. Quality Payment Program ICRs Regarding Third-Party Intermediaries
(Sec. 414.1400)
Under MIPS, the quality, Promoting Interoperability, and
improvement activities performance category data may be submitted via
relevant third-party intermediaries, such as qualified registries,
QCDRs, and health IT vendors. Data on the CAHPS for MIPS survey, which
counts as one quality performance category measure, or can be used for
completion of an improvement activity, can be submitted via CMS-
approved survey vendors. In the CY 2018 Quality Payment Program final
rule, we combined the burden for self-nomination of qualified
registries and QCDRs (82 FR 53906). For this final rule, we determined
that requirements for self-nomination for qualified registries were
sufficiently different from QCDRs that it is necessary to estimate the
two independently. The change will align the burden more closely to the
requirements for QCDRs and qualified registries to self-nominate, not
because of any change in policy in this final rule, but because of
changes in our initial assumptions. Specifically, while the processes
for self-nomination are similar, QCDRs have the option to submit QCDR
measures for the quality performance category. Therefore, differences
between QCDRs and registries self-nomination are associated with the
preparation of QCDR measures for approval. The burden associated with
qualified registry self-nomination, QCDR self-nomination, and the CAHPS
for MIPS survey vendor applications follow:
Qualified Registry Self-Nomination: The requirements and burden
associated with qualified registry self-nomination will be submitted to
OMB for approval under control number 0938-1314 (CMS-10621).
Qualified registries interested in submitting MIPS data to us on
their participants' behalf need to complete a self-nomination process
to be considered qualified to submit on behalf of MIPS eligible
clinicians or groups (82 FR 53815).
In the CY 2018 Quality Payment Program final rule, previously
approved qualified registries in good standing (that are not on
probation or disqualified) that wish to self-nominate using the
simplified process can attest, in whole or in part, that their
previously approved form is still accurate and applicable (82 FR
53815). In the same rule, qualified registries in good standing that
would like to make minimal changes to their previously approved self-
nomination application from the previous year, may submit these
changes, and attest to no other changes from their previously approved
qualified registry application for CMS review during the self-
nomination period, from September 1 to November 1 (82 FR 53815). This
simplified self-nomination process will begin for the 2019 MIPS
performance period.
The CY 2017 Quality Payment Program final rule provided the
definition of a qualified registry to be a medical registry, a
maintenance of certification program operated by a specialty body of
the American Board of Medical Specialties or other data intermediary
that, with respect to a particular performance period, has self-
nominated and successfully completed a vetting process (as specified by
CMS) to demonstrate its compliance with the MIPS qualification criteria
specified by CMS for that performance period (81 FR 77382).
For this final rule, we have adjusted the number of respondents
(from 120 to 150) based on more recent data and a revised definition of
``respondent'' to account for self-nomination applications received but
not approved. We have also adjusted our per respondent time estimate
(from 10 hours to 3 hours) based on our review of the current burden
estimates against the existing policy. Finally, we have provided a
range of time estimates (from 10 hours to 0.5 hours) which reflect the
availability of a simplified self-nomination process for previously
approved qualified registries.
For the 2017 MIPS performance period, we received 138 applications
for nomination to be a qualified registry and 145 applications for the
2018 MIPS performance period. In continuance of this trend for the 2019
MIPS performance period, we estimate 150 nomination applications will
be received from qualified registries desiring approval to report MIPS
data, an increase of 30 respondents from our currently approved
estimate.
For this final rule, the burden associated with qualified registry
self-nomination will vary depending on the number of existing qualified
registries that will elect to use the simplified self-nomination
process in lieu of the full self-nomination process as described in the
CY 2018 Quality Payment Program final rule (82 FR 53815). The self-
nomination form is submitted electronically using the web-based tool
JIRA. For the 2018 MIPS performance period, 141 qualified registries
were approved to submit MIPS data.
In section III.I.3.k.(3)(a) of this final rule, we have finalized
our proposal to modify the definition of a QCDR to be an entity with
clinical expertise in medicine and in quality measurement development
that collects medical or clinical data on behalf of a MIPS eligible
clinician for the purpose of patient and disease tracking to foster
improvement in the quality of care provided to patients. This revised
definition of a QCDR may result in previously approved QCDRs who no
longer meet the new definition to decide to instead seek approval as
qualified registries. However, we have not received any notifications
of intent and do not have data to support changing our estimate of 150
qualified registries who will submit applications during the self-
nomination period for the CY 2020 performance period.
In the CY 2018 Quality Payment Program final rule, we estimated the
burden associated with self-nomination of a qualified registry to be 10
hours, similar to PQRS (82 FR 53907). For this final rule, we reduced
our estimate to 3 hours because registries no longer provide an XML
submission, calculated measure, or measure flow as part of the

[[Page 59998]]

self-nomination process and are not subject to a mandatory interview,
which were done previously as part of the PQRS qualified registry self-
nomination process, upon which the previous assumption of 10 hours was
based. As described in the CY 2017 Quality Payment Program final rule,
the full self-nomination process requires the submission of basic
information, a description of the process the qualified registry will
use for completion of a randomized audit of a subset of data prior to
submission, and the provision of a data validation plan along with the
results of the executed data validation plan by May 31 of the year
following the performance period (81 FR 77383 through 77384).
For the simplified self-nomination process, we have estimated 0.5
hours per qualified registry to submit a nomination, a reduction of 9.5
hours from currently approved estimates.
As shown in Table 62, we estimate that the staff involved in the
qualified registry self-nomination process will be mainly computer
systems analysts or their equivalent, who have an adjusted labor cost
of $89.18/hour. Assuming that the time associated with the self-
nomination process ranges from a minimum of 0.5 hours (for the
simplified self-nomination process) to 3 hours (for the full self-
nomination process) per qualified registry, we estimate that the annual
burden will range from 97.5 hours ([141 qualified registries x 0.5 hr]
+ [9 qualified registries x 3 hr]) to 450 hours (150 qualified
registries x 3 hr) at a cost ranging from $8,695 (97.5 hr x $89.18/hr)
to $40,131 (450 hr x $89.18/hr), respectively (see Table 62).
Independent of the change to our per response time estimate, the
increase in the number of respondents results in an adjustment of 300
hours and $26,754 (30 registries x 10 hr x $89.18/hr). Accounting for
the change in the number of qualified registries, the change in time
per qualified registry to self-nominate results in an adjustment of
between -1,402.5 hours and -125,075 ([(141 registries x -9.5 hr)] + [(9
registries x -7 hr)] at $89.18/hr) and -1,050 hours and -$93,639 (150
registries x -7 hr x $89.18/hr). When these two adjustments are
combined, the net impact ranges between -1,102.5 (-1,402.5 + 300) and -
750 (-1,050 + 300) hours and -$98,321 (-$125,075 + $26,754) and -
$66,885 (-$93,639 + $26,754).
Qualified registries must comply with requirements on the
submission of MIPS data to CMS. The burden associated with the
qualified registry submission requirements will be the time and effort
associated with calculating quality measure results from the data
submitted to the qualified registry by its participants and submitting
these results, the numerator and denominator data on quality measures,
the Promoting Interoperability performance category, and improvement
activities data to us on behalf of their participants. These
requirements are currently approved by OMB under control number 0938-
1314 (CMS-10621).
We expect that the time needed for a qualified registry to
accomplish these tasks will vary along with the number of MIPS eligible
clinicians submitting data to the qualified registry and the number of
applicable measures. However, we believe that qualified registries
already perform many of these activities for their participants. We
believe the estimates discussed earlier and shown in Table 62
represents the upper bound of registry burden, with the potential for
less additional MIPS burden if the registry already provides similar
data submission services.
Based on the assumptions previously discussed, we provide an
estimate of the total annual burden associated with a qualified
registry self-nominating to be considered ``qualified'' to submit
quality measures results and numerator and denominator data on MIPS
eligible clinicians.

Table 62--Estimated Burden for Qualified Registry Self-Nomination
------------------------------------------------------------------------
Minimum burden Maximum burden
------------------------------------------------------------------------
Number of Qualified Registry Simplified 141 0
Self-Nomination Applications submitted
(a)....................................
Number of Qualified Registry Full Self- 9 150
Nomination Applications submitted (b)..
Total Annual Hours Per Qualified 0.5 0.5
Registry for Simplified Process (c)....
Total Annual Hours Per Qualified 3 3
Registry for Full Process (d)..........
-------------------------------
Total Annual Hours for Qualified 97.5 450
Registries (e) = (a) * (c) + (b) *
(d)................................
-------------------------------
Cost Per Simplified Process Per Registry $44.59 $44.59
(@computer systems analyst's labor rate
of $89.18/hr.) (f).....................
Cost Per Full Process Per Registry $267.54 $267.54
(@computer systems analyst's labor rate
of $89.18/hr.) (g).....................
-------------------------------
Total Annual Cost for Qualified $8,695 $40,131
Registries (h) = (a) * (f) + (b) *
(g)................................
------------------------------------------------------------------------

Both the minimum and maximum burden shown in Table 62 will be
submitted for approval to OMB under control number 0938-1314 (CMS-
10621) and reflect adjustments due to review of self-nomination process
and the number of respondents. For purposes of calculating total burden
associated with the final rule as shown in Table 89, only the maximum
burden is used.
We received no public comments related to the burden estimates for
qualified registry self-nomination. The burden estimates have not been
updated from the CY 2019 PFS proposed rule (83 FR 36016 through 36018).
QCDR Self-Nomination: \43\ The requirements and burden associated
with QCDR self-nomination will be submitted to OMB for approval under
control number 0938-1314 (CMS-10621).
---------------------------------------------------------------------------

\43\ We do not anticipate any changes in the CEHRT process for
health IT vendors as we transition to MIPS. Hence, health IT vendors
are not included in the burden estimates for MIPS.
---------------------------------------------------------------------------

QCDRs interested in submitting quality, Promoting Interoperability,
and improvement activities performance category data to us on their
participants' behalf will need to complete a self-nomination process to
be considered qualified to submit on behalf of MIPS eligible clinicians
or groups.
In the CY 2018 Quality Payment Program final rule, previously
approved QCDRs in good standing (that are not on probation or
disqualified) that wish to self-nominate using the simplified process
can attest, in whole or in part, that their previously approved form is
still accurate and applicable (82 FR 53808). Existing QCDRs in good
standing that would like to make minimal changes to their previously
approved self-nomination application

[[Page 59999]]

from the previous year, may submit these changes, and attest to no
other changes from their previously approved QCDR application, for CMS
review during the self-nomination period, from September 1 to November
1 (82 FR 53808). This simplified self-nomination process will begin for
the 2019 MIPS performance period.
For this final rule, the burden associated with QCDR self-
nomination will vary depending on the number of existing QCDRs that
will elect to use the simplified self-nomination process in lieu of the
full self-nomination process as described in the CY 2018 Quality
Payment Program final rule (82 FR 53808 through 53813). The self-
nomination form is submitted electronically using the web-based tool
JIRA. For the 2018 MIPS performance period, 150 QCDRs were approved to
submit MIPS data.
For this CY 2019 Quality Payment Program final rule, we have
adjusted the number of respondents (from 113 to 200) based on more
recent data and a revised definition of ``respondent'' to account for
self-nomination applications received but not approved. We have also
adjusted the time burden estimates per respondent based on our review
of the current burden estimates against the existing policy as well as
provided a range of time burden estimates which reflect the
availability of a simplified self-nomination process for previously
approved QCDRs.
For the 2017 MIPS performance period, we received 138 self-
nomination applications from QCDRs and for the 2018 MIPS performance
period, we received 176 self-nomination applications. In continuance of
this trend for the 2019 MIPS performance period, we estimate 200 self-
nomination applications will be received from QCDRs desiring approval
to report MIPS data, an increase of 87 respondents.
In section III.I.3.k.(3)(a) of this final rule, we have finalized
our proposal to modify the definition of a QCDR to be an entity with
clinical expertise in medicine and in quality measurement development
that collects medical or clinical data on behalf of a MIPS eligible
clinician for the purpose of patient and disease tracking to foster
improvement in the quality of care provided to patients. This revised
definition of a QCDR may result in previously approved QCDRs who no
longer meet the new definition to decide to instead seek approval as
qualified registries or collaborate with another previously approved
QCDR to meet the requirements of the new definition. However, we have
not received any notifications of intent and do not have data to
support changing our estimate of 200 QCDRs who will submit applications
during the self-nomination period for the CY 2020 performance period.
In addition, we have not accounted for any costs associated with QCDRs
collaborating to meet the requirements of the new definition as
electing to do so would be a business decision made by individual
entities which is not required or endorsed by CMS and considering the
alternate path of seeking to be a qualified registry would be available
for entities seeking to continue participating in MIPS.
We estimate that the self-nomination process for QCDRs to submit on
behalf of MIPS eligible clinicians or groups for MIPS will involve
approximately 3 hours per QCDR to submit information required at the
time of self-nomination as described in the CY 2017 Quality Payment
Program final rule including basic information about the QCDR,
describing the process it will use for completion of a randomized audit
of a subset of data prior to submission, providing a data validation
plan, and providing results of the executed data validation plan by May
31 of the year following the performance period (81 FR 77383 through
77384). However, for the simplified self-nomination process, we
estimate 0.5 hours per QCDR to submit this information. The
aforementioned modification to the definition of a QCDR is not expected
to affect the estimated time for submitting the full or simplified
self-nomination. The self-nomination form is submitted electronically
using the web-based tool JIRA.
In addition, QCDRs calculate their measure results. QCDRs must
possess benchmarking capabilities (for QCDR measures) that compare the
quality of care a MIPS eligible clinician provides with other MIPS
eligible clinicians performing the same quality measures. For QCDR
measures, the QCDR must provide to us, if available, data from years
prior (for example, 2017 data for the 2019 MIPS performance period)
before the start of the performance period. In addition, the QCDR must
provide to us, if available, the entire distribution of the measure's
performance broken down by deciles. As an alternative to supplying this
information to us, the QCDR may post this information on their website
prior to the start of the performance period, to the extent permitted
by applicable privacy laws. The time it takes to perform these
functions may vary depending on the sophistication of the entity, but
we estimate that a QCDR will spend an additional 1 hour performing
these activities per measure and assume that each QCDR will submit
information for 9 QCDR measures, for a total burden of 9 hours per QCDR
(1 hr per measure x 9 measures). The estimated average of 9 measures
per QCDR is based on the number of QCDR measure submissions received in
the 2017 and 2018 MIPS performance periods and is the same for each
QCDR regardless of whether they elect to use the simplified or full
self-nomination process.
In the 2017 MIPS performance period, we received over 1,000 QCDR
measure submissions. In the 2018 MIPS performance period, we received
over 1,400 QCDR measure submissions. For the 2019 MIPS performance
period, we anticipate this trend will continue, and therefore, estimate
we will receive a total of approximately 1,800 QCDR measure
submissions, resulting in an average of 9 measure submissions per QCDR
(1,800 measure submissions/200 QCDRs).
In the CY 2018 Quality Payment Program final rule, the burden
associated with self-nomination of a QCDR was estimated to be 10 hours
(82 FR 53907). For this final rule, we are increasing the burden
associated with self-nomination to 12 hours. Because QCDRs are no
longer required to provide an XML submission and are not subject to a
mandatory interview; both of which were completed as part of the PQRS
QCDR self-nomination process upon which the previous assumption of 10
hours was based, we are eliminating 1 hour from our previous burden
assumption. Simultaneously, we are increasing our burden assumption by
3 hours to account for an increase in the number of QCDR measure
submissions being submitted. These two adjustments result in a net
increase of 2 hours per respondent from our previously approved burden
estimates.
As shown in Table 63, we estimate that the staff involved in the
QCDR self-nomination process will continue to be computer systems
analysts or their equivalent, who have an average labor cost of $89.18/
hr. Assuming that the hours per QCDR associated with the self-
nomination process ranges from a minimum of 9.5 hours (for the
simplified self-nomination process) to 12 hours (for the full self-
nomination process), we estimate that the annual burden will range from
2,025 hours ([150 QCDRs x 9.5 hr] + [50 QCDRs x 12 hr]) to 2,400 hours
(200 QCDRs x 12 hr) at a cost ranging between $180,590 (2,025 hr x
$89.18/hr) and $214,032 (2,400 hr x $89.18/hr), respectively (see Table
63).
Independent of the change to our per response time estimate, the
increase in the number of respondents results in an

[[Page 60000]]

adjustment of 870 hours and $77,587 (87 registries x 10 hr x $89.18/
hr). Accounting for the change in the number of qualified registries,
the change in time per QCDR to self-nominate results in an adjustment
of between 25 hours and $2,230 ([150 registries x -0.5 hr] + [50
registries x 2 hr] at $89.18/hr) and 400 hours and $35,672 (200
registries x 2 hr x $89.18/hr). When these two adjustments are
combined, the net impact ranges between 895 (870 + 25) hours at $79,817
($77,587 + $2,230) and 1,270 (870 + 400) hours at $113,259 ($77,587 +
$35,672).
QCDRs must comply with requirements on the submission of MIPS data
to CMS. The burden associated with the QCDR submission requirements
will be the time and effort associated with calculating quality measure
results from the data submitted to the QCDR by its participants and
submitting these results, the numerator and denominator data on quality
measures, the Promoting Interoperability performance category, and
improvement activities data to us on behalf of their participants.
These requirements are currently approved by OMB under control number
0938-1314 (CMS-10621). We expect that the time needed for a QCDR to
accomplish these tasks will vary along with the number of MIPS eligible
clinicians submitting data to the QCDR and the number of applicable
measures. However, we believe that QCDRs already perform many of these
activities for their participants. We believe the estimate noted in
this section represents the upper bound of QCDR burden, with the
potential for less additional MIPS burden if the QCDR already provides
similar data submission services.
We finalized in the CY 2018 Quality Payment Program final rule that
QCDR vendors may seek permission from another QCDR to use an existing
measure that is owned by the other QCDR (82 FR 53813). However, some
QCDR measure stewards charge a fee for the use of their QCDR measures.
We have not accounted for QCDR measure licensing costs as part of our
burden estimate due to the election to license a QCDR measure being a
business decision made by individual QCDRs which is not required or
endorsed by CMS for participation in MIPS.
Based on the assumptions previously discussed, we provide an
estimate of the total annual burden associated with a QCDR self-
nominating to be considered ``qualified'' to submit quality measures
results and numerator and denominator data on MIPS eligible clinicians.

Table 63--Estimated Burden for QCDR Self-Nomination
------------------------------------------------------------------------
Minimum burden Maximum burden
------------------------------------------------------------------------
Number of QCDR Simplified Self- 150 0
Nomination Applications submitted (a)..
Number of QCDR Full Self-Nomination 50 200
Applications submitted (b).............
Total Annual Hours Per QCDR for 9.5 9.5
Simplified Process (c).................
Total Annual Hours Per QCDR for Full 12 12
Process (d)............................
-------------------------------
Total Annual Hours for QCDRs (e) = 2,025 2,400
(a) * (c) + (b) * (d)..............
-------------------------------
Cost Per Simplified Process Per QCDR $847.21 $847.21
(@computer systems analyst's labor rate
of $89.18/hr.) (f).....................
Cost Per Full Process Per QCDR $1,070.16 $1,070.16
(@computer systems analyst's labor rate
of $89.18/hr.) (g).....................
-------------------------------
Total Annual Cost for QCDRs (h) = $180,590 $214,032
(a) * (f) + (b) * (g)..............
------------------------------------------------------------------------

Both the minimum and maximum burden shown in Table 63 will be
submitted for approval to OMB under control number 0938-1314 (CMS-
10621) and reflect adjustments due to the review of self-nomination
process and the number of respondents. For purposes of calculating
total burden associated with the final rule as shown in Table 89, only
the maximum burden will be used.
We received no public comments related to the burden estimates for
QCDR self-nomination. The burden estimates have not been updated from
the CY 2019 PFS proposed rule (83 FR 36018 through 36019), however we
have provided additional elaboration on the updated requirements for
QCDRs electing to self-nominate and our rationale for why the burden
estimates do not require additional revision.
CMS-Approved CAHPS for MIPS Survey Vendors: This rule does not
include any new or revised reporting, recordkeeping, or third-party
disclosure requirements related to CMS-approved CAHPS for MIPS survey
vendors. The CMS-approved CAHPS for MIPS survey vendor requirements and
burden are currently approved by OMB under control number 0938-1222
(CMS-10450). Consequently, we have not made any MIPS survey vendor
changes under that control number.
8. Quality Payment Program ICRs Regarding Data Submission (Sec. Sec.
414.1325 and 414.1335)
Under our current policies, two groups of clinicians will submit
quality data under MIPS: Those who submit as MIPS eligible clinicians
and other eligible clinicians who opt to submit data voluntarily but
will not be subject to MIPS payment adjustments. Although the finalized
expansion of the definition of a MIPS eligible clinician to new
clinician types and the opt-in process for MIPS participation discussed
in sections III.I.3.a and III.I.3.c.(6) of this final rule could affect
respondent counts, all of the new potential respondents had the
opportunity to participate in PQRS and as a voluntary reporter in MIPS.
Therefore, consistent with our assumptions in the CY 2017 and CY 2018
Quality Payment Program final rules that PQRS participants that are not
QPs will have participated in MIPS as voluntary respondents (81 FR
77501 and 82 FR 53908, respectively), we anticipate that this rule's
finalized expansion of the definition of a MIPS eligible clinician will
not have any incremental effect on any of our currently approved burden
estimates. For the purpose of the following analyses, we assume that
clinicians who participated in MIPS and who are not QPs in Advanced
APMs in the 2017 MIPS performance period will continue to submit
quality data in the 2019 MIPS performance period. We assume that 100
percent of APM Entities in MIPS APMs will submit quality data to CMS as
required under their models. We estimate a total of 964,246 clinicians
participated as individuals or groups in the 2017 MIPS performance
period; this number differs from the currently approved estimate (OMB
0938-1314, CMS-10621) of 758,267 due to the availability of updated
data.

[[Page 60001]]

As discussed in section III.I.3.h.(1)(b) of this final rule, we are
replacing the term ``submission mechanism'' with the terms ``collection
type'' and ``submission type.'' ``Submission mechanism'' is presently
used to refer not only to the mechanism by which data is submitted, but
also to certain types of measures and activities on which data are
submitted to the entities submitting such data in the Quality Payment
Program.
We assume that clinicians and groups will continue to submit
quality data for the same collection types they used during the CY 2017
performance period. In addition, we assume that the 80 TINs that elect
to form 16 virtual groups will continue to collect and submit MIPS data
using the same collection and submission types as they did during the
2017 MIPS performance period, but the submission will be at the virtual
group, rather than group level. Our burden estimates for the quality
performance category do not include the burden for the quality data
that APM Entities submit to fulfill the requirements of their models.
The burden is excluded as sections 1899(e) and 1115A(d)(3) of the Act
(42 U.S.C. 1395jjj(e) and 1315a(d)(3), respectively) state the Shared
Savings Program and the testing, evaluation, and expansion of
Innovation Center models tested under section 1115A of the Act (or
section 3021 of the Affordable Care Act) are not subject to the
PRA.\44\ Tables 64, 65, and 66 explain our revised estimates of the
number of organizations (including groups, virtual groups, and
individual MIPS eligible clinicians) submitting data on behalf of
clinicians segregated by collection type.
---------------------------------------------------------------------------

\44\ Our estimates do reflect the burden on MIPS APM
participants of submitting Promoting Interoperability performance
category data, which is outside the requirements of their models.
---------------------------------------------------------------------------

Table 64 provides our estimated counts of clinicians that will
submit quality performance category data as MIPS individual clinicians
or groups in the 2019 MIPS performance period based on data from the
2017 MIPS performance period.
For the 2019 MIPS performance period, respondents will have the
option to submit quality performance category data via Medicare Part B
claims, direct, and log in and upload submission types, and CMS Web
Interface. At the time of the CY 2019 PFS proposed rule, participation
data by submission type and user research data to inform burden
assumptions was not available to estimate burden by submission type. As
a result, we estimate the burden for collecting data via collection
type: Claims, QCDR and MIPS CQMs, eCQMs, and the CMS Web Interface.
While we have more information about MIPS submissions, for this final
rule, we believe it is important to continue to estimate burden by
collection type because the public was able to comment on our
assumptions using this framework. As we gain more experience with the
program, we may revise this approach through future rulemaking.
For the Medicare Part B claims collection type, in section
III.I.3.h.(1)(b) of this rule, we finalized limiting the Medicare Part
B claims collection type to small practices beginning with the 2021
MIPS payment year and allowing clinicians in small practices to report
Medicare Part B claims as a group or as individuals. We assumed in our
currently approved burden analysis that any clinician that submits
quality data codes to us for the Medicare Part B claims collection type
is intending to do so for the Quality Payment Program. We made this
assumption originally in the CY 2017 Quality Payment Program final rule
to ensure that we fully accounted for any burden that may have resulted
from our policies (81 FR 77501 through 77504). In some cases, however,
clinicians may be submitting quality data codes not only for the
Medicare Part B claims collection type, but also for MIPS CQM and QCDR
collection types. Some registries and QCDRs utilize data from claims to
populate their datasets when submitting on behalf of clinicians. We are
not able to separate out when a clinician submits a quality data code
solely for the Medicare Part B claim collection type or when a
clinician is also submitting these codes for MIPS CQM or QCDR
collection types. In addition, we see a large number of voluntary
reporters for the Medicare Part B claims collection type. Approximately
70 percent of the 257,260 clinicians we estimate will submit quality
data via Medicare Part B claims (see Table 64) are MIPS eligible
clinicians while the other 30 percent are voluntary reporters which
means our burden include estimates for a large number of voluntary
reporters. Of these clinicians who are not scored as part of an APM,
approximately 55 percent are in practices with more than 15 clinicians;
however, over 91 percent of the number in practices larger than 15
clinicians are either voluntary reporters, group reporters, or are also
reporting quality data through another collection type. Approximately
10,700 individual clinicians in non-small practices are both MIPS
eligible and scored based only on Medicare Part B claims data and of
these, 52 percent also qualify for facility-based reporting, and
therefore, will not be required to submit quality data in order to
receive facility-based quality and cost scores. It is unclear why many
clinicians are submitting quality data via an alternate collection
type, and we currently lack data to accurately estimate both the number
of clinicians who will be impacted by these finalized policies and the
potential behavioral response of those clinicians who will be required
to switch to another collection type. As a result, we will continue
using the assumption that all clinicians (except QPs) who submitted
data via the Medicare Part B claims collection type in the 2017 MIPS
performance period will continue to do so for MIPS in order to avoid
overstating the impact of the change. We intend to update this burden
estimate with additional data as it becomes available. We solicited
comment on potential other assumptions for capturing the Medicare Part
B claims burden, but no comments were received.
Using our revised terminology, clinicians who used a QCDR or
Registry will now collect measures via QCDR or MIPS CQM collection
type; clinicians who used the EHR submission type will elect the eCQM
collection type, and groups that elected the CMS Web Interface for MIPS
will continue to elect the CMS Web Interface for MIPS.
Table 64 shows that in the 2019 MIPS performance period, an
estimated 257,260 clinicians will submit data as individuals for the
Medicare Part B claims collection type; 324,693 clinicians will submit
data as individuals or as part of groups for the MIPS CQM or QCDR
collection types; 243,062 clinicians will submit data as individuals or
as part of groups via eCQM collection types; and 139,231 clinicians
will submit as part of groups via the CMS Web Interface.
Table 64 provides estimates of the number of clinicians to collect
quality measures data via each collection type, regardless of whether
they decide to submit as individual clinicians or as part of groups.
Because our burden estimates for quality data submission assume that
burden is reduced when clinicians elect to submit as part of a group,
we also separately estimate the expected number of clinicians to submit
as individuals or part of groups.

[[Page 60002]]

Table 64--Estimated Number of Clinicians Submitting Quality Performance Category Data by Collection Type
----------------------------------------------------------------------------------------------------------------
Medicare Part CMS web
B claims QCDR/MIPS CQM eCQM interface Total
----------------------------------------------------------------------------------------------------------------
Number of clinicians to collect 257,260 324,693 243,062 139,231 964,246
data by collection type (as
individual clinicians or
groups) in Quality Payment
Program Year 3 (excludes QPs)
(a)............................
* Number of clinicians to 278,039 255,228 131,133 93,867 758,267
collect data by collection type
(as individual clinicians or
groups) in Quality Payment
Program Year 2 (excludes QPs)
(b)............................
Difference between Year 3 and -20,779 +69,465 +111,929 +45,364 +205,979
Year 2 (c) = (a) - (b).........
----------------------------------------------------------------------------------------------------------------
* Currently approved by OMB under control number 0938-1314 (CMS-10621).

In the CY 2018 Quality Payment Program final rule (82 FR 53625
through 53626), beginning with the 2019 MIPS performance period, we
allowed MIPS eligible clinicians to submit data for multiple collection
types for a single performance category. Therefore, we captured the
burden of any eligible clinician that may have historically collected
via multiple collection types, as we assume they will continue to
collect via multiple collection types and that our MIPS scoring
methodology will take the highest score where the same measure is
submitted via multiple collection types. Hence, the estimated numbers
of individual clinicians and groups to collect via the various
collection types are not mutually exclusive and reflect the occurrence
of individual clinicians or groups that collected data via multiple
collection types during the MIPS 2017 performance period.
Table 65 uses methods similar to those described for Table 64 to
estimate the number of clinicians that will submit data as individual
clinicians via each collection type in the 2019 MIPS performance
period. We estimate that approximately 257,260 clinicians will submit
data as individuals using the Medicare Part B claims collection type;
approximately 71,439 clinicians will submit data as individuals using
MIPS CQMs or QCDR collection types; and approximately 47,557 clinicians
will submit data as individuals using eCQMs collection type.

Table 65--Estimated Number of Clinicians Submitting Quality Performance Category Data as Individuals by
Collection Type
----------------------------------------------------------------------------------------------------------------
Medicare Part CMS web
B claims QCDR/MIPS CQM eCQM interface Total
----------------------------------------------------------------------------------------------------------------
Number of Clinicians to submit 257,260 71,439 47,557 0 376,256
data as individuals in Quality
Payment Program Year 3
(excludes QPs) (a).............
* Number of Clinicians to submit 278,039 104,281 52,709 0 435,029
data as individuals in Quality
Payment Program Year 2
(excludes QPs) (b).............
Difference between Year 3 and -20,779 -32,842 -5,152 0 -58,773
Year 2 (c) = (a) - (b).........
----------------------------------------------------------------------------------------------------------------
* Currently approved by OMB under control number 0938-1314 (CMS-10621).

To be consistent with the policy in the CY 2018 Quality Payment
Program final rule that for MIPS eligible clinicians who collect
measures via Medicare Part B claims, MIPS CQM, eCQM, or QCDR collection
types and submit more than the required number of measures (82 FR 53735
through 54736), we will score the clinician on the required measures
with the highest assigned measure achievement points. Therefore, our
columns in Table 65 are not mutually exclusive.
Table 66 provides our estimated counts of groups or virtual groups
that will submit quality data on behalf of clinicians for each
collection type in the 2019 MIPS performance period and reflects our
assumption that the formation of virtual groups will reduce burden. We
assume that groups that submitted quality data as groups in the 2017
MIPS performance period will continue to submit quality data either as
groups or virtual groups for the same collection types as they did as a
group or TIN within a virtual group for the 2019 MIPS performance
period. First, we estimated the number of groups or virtual groups that
will collect data via each collection type during the 2019 MIPS
performance period using data from the 2017 MIPS performance period.
The second and third steps in Table 66 reflect our currently approved
assumption that virtual groups will reduce the burden for quality data
submission by reducing the number of organizations that will submit
quality data on behalf of clinicians. We assume that 40 groups that
previously collected on behalf of clinicians via QCDR or MIPS CQM
collection types will elect to form 8 virtual groups that will collect
via QCDR and MIPS CQM collection types. We assume that another 40
groups that previously collected on behalf of clinicians via eCQM
collection types will elect to form another 8 virtual groups that will
collect via eCQM collection types. Hence, the second step in Table 66
is to subtract out the estimated number of groups under each collection
type that will elect to form virtual groups, and the third step in
Table 66 is to add in the estimated number of virtual groups that will
submit on behalf of clinicians for each collection type.
Specifically, we assume that 10,542 groups and virtual groups will
submit data for the QCDR or MIPS CQM collection types on behalf of
253,254 clinicians; 4,304 groups and virtual groups will submit for
eCQM collection types on behalf of 195,505 eligible clinicians; and 286
groups will submit data via the CMS Web Interface on behalf of 139,231
clinicians. Because we are using 2017 MIPS performance period
participation data to estimate participation for the 2019 MIPS
performance period, our estimates do not account for the finalized
policy to allow only groups that meet the definition of a small
practice to submit quality data via the Medicare Part B claims
collection type. Due to a lack of

[[Page 60003]]

historic data identifying which clinicians in small practices would
want to submit via the Medicare Part B claims collection type and elect
to be measured as part of a group, we continue to assume these
clinicians submitting Medicare Part B claims will participate as
individuals but will review this assumption for future performance
periods.

Table 66--Estimated Number of Groups and Virtual Groups Submitting Quality Performance Category Data by
Collection Type on Behalf of Clinicians
----------------------------------------------------------------------------------------------------------------
Medicare Part CMS web
B claims QCDR/MIPS CQM eCQM interface Total
----------------------------------------------------------------------------------------------------------------
Number of groups to collect data 0 10,574 4,336 286 15,196
by collection type (on behalf
of clinicians) in Quality
Payment Program Year 3
(excludes QPs) (a).............
Subtract out: Number of groups 0 40 40 0 80
to collect data by collection
type on behalf of clinicians in
Quality Payment Program Year 3
that will submit as virtual
groups in Quality Payment
Program Year 3 (b).............
Add in: Number of virtual groups 0 8 8 0 16
to collect data by collection
type on behalf of clinicians in
Quality Payment Program Year 3
(c)............................
Number of groups to collect data 0 10,542 4,304 286 15,132
by collection type on behalf of
clinicians in Quality Payment
Program Year 3 (d) = (a)-(b) +
(c)............................
* Number of groups to collect 0 2,936 1,509 296 4,741
data by collection type on
behalf of clinicians in Quality
Payment Program Year 2 (e).....
Difference between Year 3 and 0 +7,606 +2,795 -10 +10,391
Year 2 (f) = (d)-(e)...........
----------------------------------------------------------------------------------------------------------------
* Currently approved by OMB under control number 0938-1314 (CMS-10621).

The burden estimates associated with submission of quality
performance category data have some limitations. We believe it is
difficult to quantify the burden accurately because clinicians and
groups may have different processes for integrating quality data
submission into their practices' work flows. Moreover, the time needed
for a clinician to review quality measures and other information,
select measures applicable to their patients and the services they
furnish, and incorporate the use of quality measures into the practice
workflows is expected to vary along with the number of measures that
are potentially applicable to a given clinician's practice and by the
collection type. For example, clinicians submitting data via the
Medicare Part B claims collection type need to integrate the capture of
quality data codes for each encounter whereas clinicians submitting via
the eCQM collection types may have quality measures automated as part
of their EHR implementation.
We believe the burden associated with submitting quality measures
data will vary depending on the collection type selected by the
clinician, group, or third-party. As such, we separately estimated the
burden for clinicians, groups, and third parties to submit quality
measures data by the collection type used. For the purposes of our
burden estimates for the Medicare Part B claims, MIPS CQM and QCDR, and
eCQM collection types, we also assume that, on average, each clinician
or group will submit 6 quality measures. In terms of the quality
measures available for clinicians and groups to report for the 2019
MIPS performance period, the total number of quality measures will be
257. These measures are stratified by collection type in Table 67, as
well as counts of new, removed, and substantively changed measures.

Table 67--Summary of Quality Measures for the 2019 MIPS Performance Period
----------------------------------------------------------------------------------------------------------------
Number of
Number of Number of measures Number of
Collection type measures measures finalized with measures
finalized as finalized for a substantive remaining for
new removal change CY 2019
----------------------------------------------------------------------------------------------------------------
Medicare Part B Claims Specifications........... 0 7 1 64
MIPS CQMs Specifications........................ 6 21 0 233
eCQM Specifications............................. 2 6 0 50
Survey--CSV..................................... 0 0 0 1
CMS Web Interface Measure Specifications........ 0 1 4 10
Administrative Claims........................... 0 0 0 1
---------------------------------------------------------------
Total....................................... 8 * 26 5 * 257
----------------------------------------------------------------------------------------------------------------
* A measure may be applicable to more than one collection type but will only be counted once in the total.

For the 2019 MIPS performance period, there is a net reduction of
18 quality measures across all collection types. We do not anticipate
that removing these measures will increase or decrease the reporting
burden on clinicians and groups.
Quality Payment Program Identity Management Application Process:
The requirements and burden associated with the application process
will be

[[Page 60004]]

submitted to OMB for approval under control number 0938-1314 (CMS-
10621).
In the CY 2018 Quality Payment Program final rule, the time
associated with the Identity Management Application Process was
described as ``Obtain Account in CMS-Specified Identity Management
System'' and included in the ICR for Quality Data Submission by
Clinicians and Groups: EHR Submission for a total burden of 54,218
hours (1 hr x 54,218 respondents) (82 FR 53914). After our review of
the quality data submission process, we determined the burden
associated with the application process (3,741 hours) should be
accounted for in a separate ICR. Our per respondent burden estimate
remains unchanged at 1 hour per response.
For an individual, group, or third-party to submit MIPS quality,
improvement activities, or Promoting Interoperability performance
category data using either the log in and upload or the log in and
attest submission type or to access feedback reports, the submitter
must have a CMS Enterprise Portal user account. Once the user account
is created, registration is not required again for future years.
Based on the number of new TINs registered in the 2017 MIPS
performance period, we estimate 3,741 eligible clinicians, groups, or
third-parties will register for new accounts for the 2019 MIPS
performance period. As shown in Table 68, it will take 1 hour at
$89.18/hr for a computer systems analyst (or their equivalent) to
obtain an account for the CMS Enterprise Portal. In aggregate, we
estimate an annual burden of 3,741 hours (3,741 registrations x 1 hr/
registration) at a cost of $333,622 (3,741 hr x $89.18/hr) or $89.18
per registration.

Table 68--Estimated Burden for Quality Payment Program Identity
Management Application Process
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
Number of New TINs completing the Identity Management 3,741
Application Process (a)................................
---------------
Total Hours Per Application (b)......................... 1
---------------
Total Annual Hours for completing the Identity 3,741
Management Application Process (c) = (a) * (b).....
---------------
Cost Per Application @ computer systems analyst's labor $89.18
rate of $89.18/hr.) (d)................................
---------------
Total Annual Cost for completing the Identity $333,622
Management Application Process (e) = (a) * (d).....
------------------------------------------------------------------------

We received no public comments related to the burden estimates for
the Identity Management Application Process. The burden estimates have
not been updated from the CY 2019 PFS proposed rule (83 FR 36022
through 36023).
Quality Data Submission by Clinicians: Medicare Part B Claims-Based
Collection Type: The requirements and burden associated with
clinicians' Medicare Part B claims-based data submissions will be
submitted to OMB for approval under control number 0938-1314 (CMS-
10621).
As noted in Table 64, based on 2017 MIPS performance period data,
we assume that 257,260 individual clinicians will collect and submit
quality data via the Medicare Part B claims collection type. We
continue to anticipate that the Medicare Part B claims submission
process for MIPS is operationally similar to the way the claims
submission process functioned under the PQRS. Specifically, clinicians
will need to gather the required information, select the appropriate
QDCs, and include the appropriate QDCs on the Medicare Part B claims
they submit for payment. Clinicians will collect QDCs as additional
(optional) line items on the CMS-1500 claim form or the electronic
equivalent HIPAA transaction 837-P, approved by OMB under control
number 0938-1197. This final rule's provisions do not necessitate the
revision of either form.
In this final rule, we have adjusted the number of respondents
based on more recent data and adjusted our per respondent time
estimates so that they correctly align with the number of required
measures for which MIPS data must be submitted (6 measures) in
comparison to the number of measures previously required under PQRS (9
measures).
The total estimated burden of Medicare Part B claims-based
submission will vary along with the volume of Medicare Part B claims on
which the submission is based. Based on our experience with PQRS, we
estimate that the burden for submission of MIPS quality data will range
from 0.15 to 7.2 hours per clinician, a reduction from the range of
0.22 to 10.8 hours as set out in the CY 2018 Quality Payment Program
final rule (82 FR 53912). In the same rule, the 33 percent reduction in
the number of measures (from 9 to 6) was erroneously omitted from our
burden calculations; it is reflected in this final rule's burden
estimates. The wide range of estimates for the time required for a
clinician to submit quality measures via Medicare Part B claims
reflects the wide variation in complexity of submission across
different clinician quality measures. As shown in Table 69, we estimate
that the cost of quality data submission using Medicare Part B claims
will range from $13.38 (0.15 hr x $89.18/hr) to $642.10 (7.2 hr x
$89.18/hr). The burden will involve becoming familiar with MIPS data
submission requirements. We believe that the start-up cost for a
clinician's practice to review measure specifications is 7 hours,
consisting of 3 hours at $107.38/hr for a practice administrator, 1
hour at $206.44/hr for a clinician, 1 hour at $43.96/hr for an LPN/
medical assistant, 1 hour at $89.18/hr for a computer systems analyst,
and 1 hour at $36.98/hr for a billing clerk.
The estimate for reviewing and incorporating measure specifications
for the claims collection type is higher than that of QCDRs/Registries
or eCQM collection types due to the more manual, and therefore, more
burdensome nature of claims measures.
Considering both data submission and start-up requirements, the
estimated time (per clinician) ranges from a minimum of 7.15 hours
(0.15 hr + 7 hr) to a maximum of 14.2 hours (7.2 hr + 7 hr). In this
regard the total annual burden ranges from 1,819,082 hours (7.15 hr x
254,417 clinicians) to 3,612,721 hours (14.2 hr x 254,417 clinicians).
The estimated annual cost (per clinician) ranges from $712.08 ($13.38 +
$322.14 + $89.18 + $43.96 + $36.98 + $206.44) to a maximum of $1,340.80
($642.10 + $322.14 + $89.18 + $43.96 + $36.98 + $206.44). The total
annual burden ranges from a minimum

[[Page 60005]]

of $183,189,701 (257,260 clinicians x $712.08) to a maximum of
$344,934,208 (257,260 clinicians x $1,340.80).
Table 69 summarizes the range of total annual burden associated
with clinicians submitting quality data via Medicare Part B claims.
Independent of the change in the number of respondents, the change
in estimated time per clinician results in a burden adjustment of
between -19,463 hours at -$1,860,081 (278,039 clinicians x -0.07 hr x
$89.18/hr) and -1,000,941 hours at -$89,261,641 (278,039 clinicians x -
3.6 hr x $89.18/hr). Accounting for the change in the time burden per
respondent, the decrease in number of respondents results in a total
adjustment of between -148,713 hours at -$14,810,552 (-20,799
respondents x $712.08/respondent) and -295,346 hours at -$27,887,299 (-
20,779 respondents x $1,340.80/respondent). When these two adjustments
are combined, the net adjustment ranges between -168,176 (-19,463 -
148,713) hours at -$16,670,633 (-$1,860,081 -$14,810,552) and -
1,296,287 (-1,000,941 -295,346) hours at -$117,148,940 (-$89,261,641 -
$27,887,299).

Table 69--Estimated Burden for Quality Performance Category: Clinicians Using the Medicare Part B Claims
Collection Type
----------------------------------------------------------------------------------------------------------------
Maximum burden
Minimum burden Median burden estimate
----------------------------------------------------------------------------------------------------------------
Number of Clinicians (a)........................................ 257,260 257,260 257,260
Hours Per Clinician to Submit Quality Data (b).................. 0.15 1.05 7.2
Number of Hours Practice Administrator Review Measure 3 3 3
Specifications (c).............................................
Number of Hours Computer Systems Analyst Review Measure 1 1 1
Specifications (d).............................................
Number of Hours LPN Review Measure Specifications (e)........... 1 1 1
Number of Hours Billing Clerk Review Measure Specifications (f). 1 1 1
Number of Hours Clinician Review Measure Specifications (g)..... 1 1 1
Annual Hours per Clinician (h) = (b) + (c) + (d) + (e) + (f) + 7.15 8.05 14.2
(g)............................................................
-----------------------------------------------
Total Annual Hours (i) = (a) * (h).......................... 1,839,409 2,070,943 3,653,092
-----------------------------------------------
Cost to Submit Quality Data (@ computer systems analyst's labor $13.38 $93.64 $642.10
rate of $89.18/hr.) (j)........................................
Cost to Review Measure Specifications (@ practice $322.14 $322.14 $322.14
administrator's labor rate of $107.38/hr.) (k).................
Cost to Review Measure Specifications (@ computer systems $89.18 $89.18 $89.18
analyst's labor rate of $89.18/hr.) (l)........................
Cost to Review Measure Specifications (@ LPN's labor rate of $43.96 $43.96 $43.96
$43.96/hr.) (m)................................................
Cost to Review Measure Specifications (@ billing clerk's labor $36.98 $36.98 $36.98
rate of $36.98/hr.) (n)........................................
Cost to Review Measure Specifications (@ physician's labor rate $206.44 $206.44 $206.44
of $206/44/hr.) (o)............................................
-----------------------------------------------
Total Annual Cost Per Clinician (p) = (j) + (k) + (l) + (m) $712.08 $792.34 $1,340.80
+ (n) + (o)................................................
-----------------------------------------------
Total Annual Cost (q) = (a) * (p)....................... $183,189,701 $203,837,388 $344,934,208
----------------------------------------------------------------------------------------------------------------

We received no public comments related to the burden estimates for
quality performance category: Clinicians using the Medicare Part B
claims collection type. However, the burden estimates have been updated
from the CY 2019 PFS proposed rule to reflect availability of data from
the 2017 MIPS performance period (83 FR 36023 through 36024).
Quality Data Submission by Individuals and Groups Using MIPS CQM
and QCDR Collection Types: This final rule does not include any new or
revised reporting, recordkeeping, or third-party disclosure
requirements related to this CQM and QCDR collection types. However, we
have adjusted the number of respondents based on more recent data. The
adjusted burden will be submitted to OMB for approval under control
number 0938-1314 (CMS-10621).
As noted in Tables 64, 65, and 66, and based on 2017 MIPS
performance period data, we assume that 324,693 clinicians will submit
quality data as individuals or groups using MIPS CQM or QCDR collection
types. Of these, we expect 71,439 clinicians, as shown in Table 65,
will submit as individuals and 10,542 groups, as shown in Table 66, are
expected to submit on behalf of the remaining 253,254 clinicians. Given
that the number of measures required is the same for clinicians and
groups, we expect the burden to be the same for each respondent
collecting data via MIPS CQM or QCDR, whether the clinician is
participating in MIPS as an individual or group.
Under the MIPS CQM and QCDR collection types, the individual
clinician or group may either submit the quality measures data directly
to us, log in and upload a file, or utilize a third-party intermediary
to submit the data to us on the clinician's or group's behalf.
We estimate that the burden associated with the QCDR collection
type is similar to the burden associated with the MIPS CQM collection
type; therefore, we discuss the burden for both together below. For
MIPS CQM and QCDR collection types, we estimate an additional time for
respondents (individual clinicians and groups) to become familiar with
MIPS submission requirements and, in some cases, specialty measure sets
and QCDR measures. Therefore, we believe that the burden for an
individual clinician or group to review measure specifications and
submit quality data total 9.083 hours at $858.86. This consists of 3
hours at $89.18/hr for a computer systems analyst (or their equivalent)
to submit quality data along with 2 hours at $107.38/hr for a practice
administrator, 1 hour at $89.18/hr for a computer systems analyst, 1
hour at $43.96/hr for a LPN/medical assistant, 1 hour at $36.98/hr for
a billing clerk, and 1 hour at $206.44/hr for a clinician to review
measure specifications. Additionally, clinicians and groups will need
to authorize or instruct the qualified registry or QCDR to submit
quality measures' results and numerator and denominator data on quality
measures to us on their behalf. We

[[Page 60006]]

estimate that the time and effort associated with authorizing or
instructing the quality registry or QCDR to submit this data will be
approximately 5 minutes (0.083 hours) per clinician or group
(respondent) for a cost of $7.40 (0.083 hr x $89.18/hr for a computer
systems analyst).
In aggregate, we estimate an annual burden of 744,633 hours (9.083
hr/response x 81,981 groups plus clinicians submitting as individuals)
at a cost of $71,016,861 (81,981 responses x $866.26/response). The
decrease in number of respondents results in a total adjustment of -
229,219 hours at -$21,860,937 (-25,236 respondents x $866.26/
respondent). Based on these assumptions, we have estimated in Table 70
the burden for these submissions.

Table 70--Estimated Burden for Quality Performance Category: Clinicians
(Participating Individually or as Part of a Group) Using the MIPS CQM/
QCDR Collection Type
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
Number of clinicians submitting as individuals (a)...... 71,439
Number of groups submitting via QCDR or MIPS CQM on 10,542
behalf of individual clinicians (b)....................
Number of Respondents (groups plus clinicians submitting 81,981
as individuals) (c) = (a) + (b)........................
Hours Per Respondent to Report Quality Data (d)......... 3
Number of Hours Practice Administrator Review Measure 2
Specifications (e).....................................
Number of Hours Computer Systems Analyst Review Measure 1
Specifications (f).....................................
Number of Hours LPN Review Measure Specifications (g)... 1
Number of Hours Billing Clerk Review Measure 1
Specifications (h).....................................
Number of Hours Clinician Review Measure Specifications 1
(i)....................................................
Number of Hours Per Respondent to Authorize Qualified 0.083
Registry to Report on Respondent's Behalf (j)..........
Annual Hours Per Respondent (k) = (d) + (e) + (f) + (g) 9.083
+ (h) + (i) + (j)......................................
---------------
Total Annual Hours (l) = (c) * (k).................. 744,633
---------------
Cost Per Respondent to Submit Quality Data (@ computer $267.54
systems analyst's labor rate of $89.18/hr.) (m)........
Cost to Review Measure Specifications (@ practice $214.76
administrator's labor rate of $107.38/hr.) (n).........
Cost Computer System's Analyst Review Measure $89.18
Specifications (@ computer systems analyst's labor rate
of $89.18/hr.) (o).....................................
Cost LPN Review Measure Specifications (@ LPN's labor $43.96
rate of $43.96/hr.) (p)................................
Cost Billing Clerk Review Measure Specifications (@ $36.98
clerk's labor rate of $36.98/hr.) (q)..................
Cost Clinician Review Measure Specifications (@ $206.44
physician's labor rate of $206.44/hr.) (r).............
Cost for Respondent to Authorize Qualified Registry/QCDR $7.40
to Report on Respondent's Behalf (@ computer systems
analyst's labor rate of $89.18/hr.) (s)................
---------------
Total Annual Cost Per Respondent (t) = (m) + (n) + $866.26
(o) + (p) + (q) + (r) + (s)........................
---------------
Total Annual Cost (u) = (c) * (t)............... $71,016,861
------------------------------------------------------------------------

We received no public comments related to the burden estimates for
quality performance category: Clinicians using the MIPS CQM/QCDR
collection type. However, the burden estimates have been updated from
the CY 2019 PFS proposed rule to reflect availability of data from the
2017 MIPS performance period (83 FR 36024 through 36025).
Quality Data Submission by Clinicians and Groups: eCQM Collection
Type: This final rule does not include any new or revised reporting,
recordkeeping, or third-party disclosure requirements related to the
eCQM collection type. However, we have adjusted the number of
respondents based on more recent data. The adjusted burden will be
submitted to OMB for approval under control number 0938-1314 (CMS-
10621).
As noted in Tables 64, 65, and 66, based on 2017 MIPS performance
period data, we assume that 243,062 clinicians will elect to use the
eCQM collection type; 47,557 clinicians are expected to submit eCQMs as
individuals; and 4,304 groups are expected to submit eCQMs on behalf of
the remaining 195,505 clinicians. We expect the burden to be the same
for each respondent using the eCQM collection type, whether the
clinician is participating in MIPS as an individual or group.
In the CY 2018 Quality Payment Program final rule, the time
required for users to obtain an account for the CMS Enterprise Portal
was included in this Quality Data Submission by Clinicians and Groups:
eCQM Collection Type ICR (82 FR 53914). However, in this final rule, we
are finalizing a separate ICR for this activity (now described as the
Quality Payment Program Identity Management Application Process; see
Table 68) and therefore, reduce (by 1 hour) our per respondent burden
estimate for this ICR commensurately. We have also adjusted the number
of respondents based on more recent data.
Under the eCQM collection type, the individual clinician or group
may either submit the quality measures data directly to us from their
eCQM, log in and upload a file, or utilize a health IT vendor to submit
the data to us on the clinician's or group's behalf.
To prepare for the eCQM collection type, the clinician or group
must review the quality measures on which we will be accepting MIPS
data extracted from eCQMs, select the appropriate quality measures,
extract the necessary clinical data from their CEHRT, and submit the
necessary data to the CMS-designated clinical data warehouse or use a
health IT vendor to submit the data on behalf of the clinician or
group. We assume the burden for collecting quality measures data via
eCQM is similar for clinicians and groups who submit their data
directly to us from their CEHRT and clinicians and groups who use a
health IT vendor to submit the data on their behalf. This includes
extracting the necessary clinical data from their CEHRT and submitting
the necessary data to the CMS-designated clinical data warehouse.
We continue to estimate that it will take no more than 2 hours at
$89.18/hr for a computer systems analyst to submit the actual data
file. The burden

[[Page 60007]]

will also involve becoming familiar with MIPS submission. In this
regard, we estimate it will take 6 hours for a clinician or group to
review measure specifications. Of that time, we estimate 2 hours at
$107.38/hr for a practice administrator, 1 hour at $206.44/hr for a
clinician, 1 hour at $89.18/hr for a computer systems analyst, 1 hour
at $43.96/hr for a LPN/medical assistant, and 1 hour at $36.98/hr for a
billing clerk.
In aggregate we estimate an annual burden of 414,888 hours (8 hr x
51,861 groups and clinicians submitting as individuals) at a cost of
$39,916,374 (51,861 responses x $769.68/response) (see Table 71).
Independent of the change in the number of respondents, removing
the time burden associated with completing the Quality Payment Program
Identity Management Application Process results in an adjustment to the
total burden of -54,218 hours and -$4,835,161 (54,218 respondents x -1
hr x $89.18/hr). Accounting for the change in the per respondent time
estimate, the decrease in number of respondents results in a total
adjustment of -18,856 hours at -$1,814,136 (-2,357 respondents x
$769.68/respondent). When these two adjustments are combined, the net
adjustment is -73,074 (-54,218-18,856) hours at -$6,649,297 (-
$4,835,161-$1,814,136).

Table 71--Estimated Burden for Quality Performance Category: Clinicians
(Submitting Individually or as Part of a Group) Using the eCQM
Collection Type
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
Number of clinicians submitting as individuals (a)...... 47,557
Number of Groups submitting via EHR on behalf of 4,304
individual clinicians (b)..............................
Number of Respondents (groups and clinicians submitting 51,861
as individuals) (c) = (a) + (b)........................
Hours Per Respondent to Submit MIPS Quality Data File to 2
CMS (d)................................................
Number of Hours Practice Administrator Review Measure 2
Specifications (e).....................................
Number of Hours Computer Systems Analyst Review Measure 1
Specifications (f).....................................
Number of Hours LPN Review Measure Specifications (g)... 1
Number of Hours Billing Clerk Review Measure 1
Specifications (h).....................................
Number of Hours Clinicians Review Measure Specifications 1
(i)....................................................
Annual Hours Per Respondent (j) = (d) + (e) + (f) + (g) 8
+ (h) + (i)............................................
---------------
Total Annual Hours (k) = (c) * (j).................. 414,888
---------------
Cost Per Respondent to Submit Quality Data (@ computer $178.36
systems analyst's labor rate of $88.10/hr.) (l)........
Cost to Review Measure Specifications (@ practice $214.76
administrator's labor rate of $105.16/hr.) (m).........
Cost to Review Measure Specifications (@ computer $89.18
systems analyst's labor rate of $88.10/hr.) (n)........
Cost to Review Measure Specifications (@ LPN's labor $43.96
rate of $43.12/hr.) (o)................................
Cost to Review Measure Specifications (@ clerk's labor $36.98
rate of $36.12/hr.) (p)................................
Cost to D21Review Measure Specifications (@ physician's $206.44
labor rate of $202.08/hr.) (q).........................
---------------
Total Cost Per Respondent (r) = (l) + (m) + (n) + $769.68
(o) + (p) + (q)....................................
---------------
Total Annual Cost (s) = (c) * (r)............... $39,916,374
------------------------------------------------------------------------

We received no public comments related to the burden estimates for
quality performance category: Clinicians using the eCQM collection
type. However, the burden estimates have been updated from the CY 2019
PFS proposed rule to reflect availability of data from the 2017 MIPS
performance period (83 FR 36025 through 36026).
Quality Data Submission via CMS Web Interface: The finalized
requirements and burden associated with CMS Web Interface data
submission will be submitted to OMB for approval under control number
0938-1314 (CMS-10621).
As discussed in section III.I.3.h.(2)(a)(iii)(A)(bb) of this rule,
we are finalizing a 33 percent reduction in the number of measures
(from 15 to 10 measures) for which clinicians are required to submit
quality data via the CMS Web Interface. To account for the decrease in
measures, we are also finalizing a decrease to our per respondent time
estimate.
We assume that 286 groups will submit quality data via the CMS Web
Interface based on the number of groups who registered for using the
CMS Web Interface during the 2018 MIPS performance period. This is a
decrease of 10 groups from the currently approved number provided in
the CY 2018 Quality Payment Program final rule (82 FR 53915) due to
receipt of more current data. We estimate that approximately 91,757
clinicians will submit via this method.
The burden associated with the group submission requirements is the
time and effort associated with submitting data on a sample of the
organization's beneficiaries that is prepopulated in the CMS Web
Interface. In the CY 2018 Quality Payment Program final rule, we
estimated that it would take, on average, 74 hours for each group to
submit quality measures data via the CMS Web Interface (82 FR 53915).
Of those hours, approximately half (or 37 hr) are unaffected by the
number of required measures while the other half (37 hr) are affected
proportionately by the number of required measures (37 hr x 33 percent
reduction = 24.67 hr). Accounting for the finalized reduction in
required measures, our revised estimate for the time to submit data via
the CMS Web Interface for the 2019 MIPS performance period is 61.67
hours (37 hr + 24.67 hr), a reduction of 12.33 hours or approximately
18 percent of the currently approved 74 hour time estimate. Considering
only the time which varies based on the number of required measures,
the process of entering or uploading data requires approximately 2.74
hours of a computer systems analyst's time per measure (24.67 hr/9
measures). Our estimate for submission includes the time needed for
each group to populate data fields in the web interface with
information on approximately 248 eligible assigned Medicare
beneficiaries and submit the data (we will partially pre-populate the
CMS Web Interface with claims data

[[Page 60008]]

from their Medicare Part A and B beneficiaries). The patient data
either can be manually entered, uploaded into the CMS Web Interface via
a standard file format, which can be populated by CEHRT, or submitted
directly. Each group must provide data on 248 eligible assigned
Medicare beneficiaries (or all eligible assigned Medicare beneficiaries
if the pool of eligible assigned beneficiaries is less than 248) for
each measure. In aggregate, we estimate an annual burden of 17,637
hours (286 groups x 61.67 hr) at a cost of $1,572,837 (17,637 hr x
$89.18/hr).
Independent of the change in the number of respondents, the
decrease in total burden resulting from the decrease in required
measures is -3,650 hours at -$325,566 (296 groups x -12.33 hr x $89.18/
hr). Accounting for the decrease in total time, the decrease in number
of respondents results in a total adjustment of -616.7 hours at -
$54,994 (-10 respondents x 61.67 hr x $89.18/hr). When these
adjustments are combined, the net adjustment is -4,267 (-3,650-617)
hours at -$380,560 (-$325,566-$54,994).
Based on the assumptions discussed in this section, Table 72
summarizes the burden for groups submitting to MIPS via the CMS Web
Interface.

Table 72--Estimated Burden for Quality Data Submission via the CMS Web
Interface
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
Number of Eligible Group Practices (a).................. 286
Total Annual Hours Per Group to Submit (b).......... 61.67
---------------
Total Annual Hours (c) = (a) * (b).................. 17,637
---------------
Cost Per Group to Report (@ computer systems analyst's $5,499
labor rate of $89.18/hr.) (d)..........................
---------------
Total Annual Cost (e) = (a) * (d)................... $1,572,837
------------------------------------------------------------------------

We received no public comments related to the burden estimates for
quality data submission via the CMS Web Interface. However, the burden
estimates have been updated from the CY 2019 PFS proposed rule to
reflect the change in the number of required measures from 9 in the
proposed rule to 10 in the final rule (83 FR 36026 through 36027).
Beneficiary Responses to CAHPS for MIPS Survey: This rule does not
include any new or revised reporting, recordkeeping, or third-party
disclosure requirements related to the CAHPS for MIPS survey. However,
we have adjusted our currently approved burden estimates based on more
recent data. The adjusted burden will be submitted to OMB for approval
under control number 0938-1222 (CMS-10450).
In this final rule, we have adjusted the number of groups electing
to report on the CAHPS for MIPS survey as well as the average number of
beneficiaries per group based on more recent data.
Under MIPS, groups of 25 or more clinicians can elect to contract
with a CMS-approved survey vendor and use the CAHPS for MIPS survey as
one of their 6 required quality measures. Beneficiaries that choose to
respond to the CAHPS for MIPS survey will experience burden.
The usual practice in estimating the burden on public respondents
to surveys such as CAHPS is to assume that respondent time is valued,
on average, at civilian wage rates. As explained in section V.A. of
this final rule, BLS data sets out an average hourly wage for civilians
in all occupations at $24.34/hr. Although most Medicare beneficiaries
are retired, we believe that their time value is unlikely to depart
significantly from prior earnings expense, and we have used the average
hourly wage to compute our cost estimate for the beneficiaries' time.
For the 2019 MIPS performance period, we assume that 143 groups
will elect to report on the CAHPS for MIPS survey, which is equal to
the number of groups that have registered and have a sufficient
beneficiary sample size to conduct the CAHPS for MIPS survey in the
2018 MIPS performance period; a decrease of 318 from the 461 groups
currently approved by OMB. Table 73 shows the estimated annual burden
for beneficiaries to participate in the CAHPS for MIPS Survey. Based on
the number of complete and partially complete surveys for groups
participating in CAHPS for MIPS survey administration for the 2018 MIPS
performance period, we assume that an average of 273 beneficiaries will
respond per group for the 2019 MIPS performance period. Therefore, the
CAHPS for MIPS survey will be administered to approximately 39,039
beneficiaries per year (143 groups x an average of 273 beneficiaries
per group responding). This is a decrease of 93,268 from our currently
approved 132,307 beneficiary estimate.
The CAHPS for MIPS survey that will be administered in the 2019
MIPS performance period is unchanged from the survey administered in
the 2018 MIPS performance period. In that regard, we continue to
estimate an average administration time of 12.9 minutes (or 0.215 hr)
at a pace of 4.5 items per minute for the English version of the
survey. For the Spanish version, we estimate an average administration
time of 15.5 minutes (assuming 20 percent more words in the Spanish
translation). However, since less than 1 percent of surveys were
administered in Spanish for reporting year 2016, our burden estimate
reflects the time for administering the English version of the survey.
Given that we expect approximately 39,039 respondents, we estimate
an annual burden of 8,393 hours (39,039 respondents x 0.215 hr/
respondent) at a cost of $204,286 (8,393 hr x $24.34/hr).
The decrease in the number of beneficiaries responding to the CAHPS
for MIPS survey results in an adjustment to the total time burden of -
20,715 hours and -$503,556 (-93,268 beneficiaries x 0.215 hr x $24.34/
hr).

[[Page 60009]]

Table 73--Estimated Burden for Beneficiary Participation in CAHPS for
MIPS Survey
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
Number of Eligible Group Practices Administering CAHPS 143
for MIPS (a)...........................................
Number of Beneficiaries Per Group Responding to Survey 273
(b)....................................................
Number of Total Beneficiary Respondents (c) = (a) * (b). 39,039
Number of Hours Per Beneficiary Respondent (d).......... 0.215
Cost (@ labor rate of $24.34/hr.) (e)................... $24.34/hr
---------------
Total Annual Hours (f) = (c) * (d).................. 8,393
---------------
Total Annual Cost for Beneficiaries Responding $204,286
to CAHPS for MIPS (g) = (c) * (e)..............
------------------------------------------------------------------------

We received no public comments related to the burden estimates for
beneficiary participation in CAHPS for MIPS survey. However, the burden
estimates have been updated from the CY 2019 PFS proposed rule to
reflect availability of data from the 2018 MIPS performance period (83
FR 36027).
Group Registration for CMS Web Interface: This rule does not
include any new or revised reporting, recordkeeping, or third-party
disclosure requirements related to the group registration for CMS Web
Interface. However, we have adjusted our currently approved burden
estimates based on more recent data. The adjusted burden will be
submitted to OMB for approval under control number 0938-1222 (CMS-
10450).
In this final rule, we have adjusted the number of respondents
based on more recent data and adjusted our per response time estimate
based on our review of the currently approved estimates against the
existing registration process.
Groups interested in participating in MIPS using the CMS Web
Interface for the first time must complete an on-line registration
process. After first time registration, groups will only need to opt
out if they are not going to continue to submit via the CMS Web
Interface. In Table 74, we estimate that the registration process for
groups under MIPS involves approximately 0.25 hours at $89.18/hr for a
computer systems analyst (or their equivalent) to register the group.
Although the registration process remains unchanged from the CY 2018
Quality Payment Program final rule, a review of the steps required for
registration warranted a reduction of 0.75 hours in estimated burden
per group (82 FR 53917).
We assume that approximately 67 groups will elect to use the CMS
Web Interface for the first time during the 2019 MIPS performance
period based on the number of new registrations received during the CY
2018 registration period; an increase of 57 compared to the number of
groups currently approved by OMB under control number 0938-1314 (CMS-
10621). In aggregate, we estimate a burden of 16.75 hours (67 new
registrations x 0.25 hr/registration) at a cost of $1,494 (16.75 hr x
$89.18/hr).
Independent of the decrease in time burden per group, the increase
in the number of groups registering to submit MIPS data via the CMS Web
Interface results in an adjustment to the total time burden of 57 hours
at $5,083 (57 groups x 1 hr x $89.18/hr). Accounting for the increase
in the number of groups, the decrease in time burden per group to
register results in an adjustment to the total burden of -50.25 hours
at -$4,481 (67 groups x -0.75 hrs x $89.18/hr). When these adjustments
are combined, the net adjustment is 6.75 hours (57-50.25) at $602
($5,083-$4,481).

Table 74--Estimated Burden for Group Registration for CMS Web Interface
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
Number of New Groups Registering for CMS Web Interface 67
(a)....................................................
Annual Hours Per Group (b).............................. 0.25
---------------
Total Annual Hours (c) = (a) * (b).................. 16.75
---------------
Labor Rate to Register for CMS Web Interface @ computer $89.18/hr
systems analyst's labor rate) (d)......................
---------------
Total Annual Cost for CMS Web Interface Group $1,494
Registration (e) = (a) * (d).......................
------------------------------------------------------------------------

We received no public comments related to the burden estimates for
group registration for the CMS Web Interface. The burden estimates have
not been updated from the CY 2019 PFS proposed rule (83 FR 36027
through 36028).
Group Registration for CAHPS for MIPS Survey: This rule does not
include any new or revised reporting, recordkeeping, or third-party
disclosure requirements related to the group registration for the CAHPS
for MIPS Survey. However, we have adjusted our currently approved
burden estimates based on more recent data. The adjusted burden will be
submitted to OMB for approval under control number 0938-1222 (CMS-
10450).
In this final rule, we have adjusted our currently approved number
of respondents based on more recent data and adjusted our per
respondent time estimate based on our review of the current burden
estimates against the existing registration process.
Under MIPS, the CAHPS for MIPS survey counts for 1 measure toward
the MIPS quality performance category and, as a patient experience
measure, it also fulfills the requirement to submit at least one high
priority measure in the absence of an applicable outcome measure.
Groups that wish to administer the CAHPS for MIPS survey must register
by June of the applicable 12-month performance period, and
electronically notify CMS of which vendor they have selected to
administer

[[Page 60010]]

the survey on their behalf. For the 2019 MIPS performance period, we
assume that 282 groups will enroll in the MIPS for CAHPS survey based
on the number of groups which elected to register during the CY 2018
registration period; a decrease of 179 compared to the number of groups
currently approved by OMB under the aforementioned control number (82
FR 53917).
As shown in Table 75, we assume that the staff involved in the
group registration for CAHPS for MIPS Survey will mainly be computer
systems analysts (or their equivalent) who have an average labor cost
of $89.18/hr. We assume the CAHPS for MIPS Survey registration burden
consists of 0.25 hours to register for the survey as well as 0.5 hours
to select the CAHPS for MIPS Survey vendor that will be used and
electronically notifying CMS of this selection. In this regard, the
total time for CAHPS for MIPS registration is 0.75 hours. Although the
registration process remains unchanged from the CY 2018 Quality Payment
Program final rule, after we reviewed the steps required for
registration more thoroughly, we believe that the burden was less than
we had originally estimated. Therefore, we have adjusted the estimated
burden from 1.5 hours to 0.75 hours per respondent.
In aggregate, we estimate an annual burden of 211.50 hours (282
groups x 0.75 hr per group) at a cost of $18,862 (211.50 hr x $89.18/
hr).
Independent of the change in time per group, the decrease in the
number of groups registering results is an adjustment to the total
burden of -268.5 hours at -$23,945 (-179 groups x 1.5 hrs x $89.18/hr).
Accounting for the decrease in the number of groups registering, the
decrease in time per group to register results in an adjustment to the
total burden of -211.5 hours at -$18,862 (282 groups x -0.75 hr x
$89.18/hr). When these adjustments are combined, the net adjustment is
-480 hours (-268.5-211.5) at -$42,807 (-$23,945-$18,862).

Table 75--Estimated Burden for Group Registration for CAHPS for MIPS
Survey
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
# of Groups Registering for CAHPS (a)................... 282
Total Annual Hours for CAHPS Registration (b)........... 0.75
---------------
Total Annual Hours for CAHPS Registration (c) = (a) 211.5
* (b)..............................................
---------------
Labor Rate to Register for CAHPS (computer systems $89.18/hr
analyst) (d)...........................................
---------------
Total Annual Cost for CAHPS Registration (e) = (a) * $18,862
(d)................................................
------------------------------------------------------------------------

We received no public comments related to the burden estimates for
group registration for the CAHPS for MIPS survey. However, the burden
estimates have been updated from the CY 2019 PFS proposed rule to
reflect availability of data from the 2018 MIPS performance period (83
FR 36028 through 36029).
9. Quality Payment Program ICRs Regarding the Nomination of Quality
Measures
This rule does not include any new or revised reporting,
recordkeeping, or third-party disclosure requirements related to the
nomination of quality measures. However, we have adjusted our currently
approved burden estimates based on more recent data. We have also
accounted for burden associated with policies that have been finalized
but whose burden were erroneously excluded from our estimates. The new
and adjusted burden will be submitted to OMB for approval under control
number 0938-1314 (CMS-10621).
As discussed in section III.I.3.h.(2)(b)(i) of this final rule,
quality measures are selected annually through a call for quality
measures under consideration, with a final list of quality measures
being published in the Federal Register by November 1 of each year.
Under section 1848(q)(2)(D)(ii) of the Act, the Secretary must solicit
a ``Call for Quality Measures'' each year. Specifically, the Secretary
must request that eligible clinician organizations and other relevant
stakeholders identify and submit quality measures to be considered for
selection in the annual list of MIPS quality measures, as well as
updates to the measures. Under section 1848(q)(2)(D)(ii) of the Act,
eligible clinician organizations are professional organizations as
defined by nationally recognized specialty boards of certification or
equivalent certification boards.
As we described in the CY 2017 Quality Payment Program final rule
(81 FR 77137), we will accept quality measures submissions at any time,
but only measures submitted during the timeframe provided by us through
the pre-rulemaking process of each year will be considered for
inclusion in the annual list of MIPS quality measures for the
performance period beginning 2 years after the measure is submitted.
This process is consistent with the pre-rulemaking process and the
annual call for measures, which are further described at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityMeasures/Pre-Rule-Making.html.
To identify and submit a quality measure, eligible clinician
organizations and other relevant stakeholders use a one-page online
form that requests information on background, a gap analysis which
includes evidence for the measure, reliability, validity, endorsement
and a summary which includes how the proposed measure relates to the
Quality Payment Program and the rationale for the measure. In addition,
proposed measures must be accompanied by a completed Peer Review
Journal Article form.
As shown in Table 76, we estimate that approximately 140
organizations, including clinicians, CEHRT developers, and vendors,
will submit measures for the Call for Quality Measures process; an
increase of 100 compared to the number of organizations currently
approved by OMB. In keeping with the focus on clinicians as the primary
source for recommending new quality measures, we are using practice
administrators and clinician time for our burden estimates. We also
estimate it will take 0.5 hours per organization to submit an activity
to us, consisting of 0.3 hours at $107.38/hr for a practice
administrator to make a strategic decision to nominate and submit a
measure and 0.2 hours at $206.44/hr for clinician review time.
The 0.5 hour estimate assumes that submitters will have the
necessary information to complete the nomination form readily
available, which we believe is a reasonable assumption. Additionally,
some submitters familiar

[[Page 60011]]

with the process or who are submitting multiple measures may require
significantly less time, while other submitters may require more if the
opposite is true; on average we believe 0.5 hours is a reasonable
average across all submitters.
Consistent with the CY 2017 Quality Payment Program final rule, we
also estimate it will take 4 hours at $206.44/hr for a clinician (or
equivalent) to complete the Peer Review Journal Article Form (81 FR
77153 through 77155). This assumes that measure information is
available and testing is complete in order to have the necessary
information to complete the form, which we believe is a reasonable
assumption. Although the requirement for completing the Peer Review
Journal Article was previously included in the CY 2017 Quality Payment
Program final rule, the time required for completing the form was
erroneously excluded from our burden estimates.
As shown in Table 76, in aggregate we estimate an annual burden of
630 hours (140 organizations x 4.5 hr/response) at a cost of $125,896
(140 x [(0.3 hr x $107.38/hr) + (4.2 hr x $206.44/hr)].
Independent of the change in time per organization, the change in
the number of organizations nominating new quality measures results in
an adjustment of 50 hours at $7,350 (100 organizations x [(0.3 hr x
$107.38/hr) + (0.2 hr x $206.44/hr)]). When accounting for the change
in respondents, the change in burden to nominate a quality measure
results in an adjustment of 560 hours at $115,606 (140 organizations x
4 hr x $206.44/hr). When these adjustments are combined, the total
adjustment is 610 hours (560 + 50) at $122,956 ($7,350 + $115,606).

Table 76--Estimated Burden for Call for Quality Measures
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
# of Organizations Nominating New Quality Measures (a).. 140
# of Hours Per Practice Administrator to Identify and 0.30
Propose Measure (b)....................................
# of Hours Per Clinician to Identify Measure (c)........ 0.20
# of Hours Per Clinician to Complete Peer Review Article 4.00
Form (d)...............................................
Annual Hours Per Response (e) = (b) + (c) + (d)......... 4.50
---------------
Total Annual Hours (f) = (a) * (e).............. 630
---------------
Cost to Identify and Submit Measure (@ practice $32.21
administrator's labor rate of $107.38/hr.) (g).........
Cost to Identify Quality Measure and Complete Peer $867.05
Review Article Form (@ physician's labor rate of
$206.44/hr.) (h).......................................
---------------
Total Annual Cost Per Respondent (i) = (g) + (h) $899.26
---------------
Total Annual Cost (j) = (a) * (i)............... $125,896
------------------------------------------------------------------------

We received no public comments related to the burden estimates for
the Call for Quality Measures. The burden estimates have not been
updated from the CY 2019 PFS proposed rule (83 FR 36029 through 36030).
10. Quality Payment Program ICRs Regarding Promoting Interoperability
Data (Sec. Sec. 414.1375 and 414.1380)
The finalized requirements and burden discussed under this section
will be submitted to OMB for approval under control number 0938-1314
(CMS-10621).
For the 2019 MIPS performance period, clinicians and groups can
submit Promoting Interoperability data through direct, log in and
upload, or log in and attest submission types. We have worked to
further align the Promoting Interoperability performance category with
other MIPS performance categories. With the exception of submitters who
elect to use the log in and attest submission type for the Promoting
Interoperability performance category which is not available for the
quality performance category, we anticipate that most organizations
will use the same data submission type for the both of these
performance categories and that the clinicians, practice managers, and
computer systems analysts involved in supporting the quality data
submission will also support the Promoting Interoperability data
submission process. Hence, the following burden estimates show only
incremental hours required above and beyond the time already accounted
for in the quality data submission process. Although this analysis
assesses burden by performance category and submission type, we
emphasize that MIPS is a consolidated program and submission analysis
and decisions are expected to be made for the program as a whole.
Reweighting Applications for Promoting Interoperability and Other
Performance Categories: As established in the CY 2017 and CY 2018
Quality Payment Program final rules, MIPS eligible clinicians who meet
the criteria for a significant hardship or other type of exception may
submit an application requesting a zero percent weighting for the
Promoting Interoperability performance category in the following
circumstances: insufficient internet connectivity, extreme and
uncontrollable circumstances, lack of control over the availability of
CEHRT, clinicians who are in a small practice, and decertified EHR
technology (81 FR 77240 through 77243 and 82 FR 53680 through 53686).
In addition, as finalized in the CY 2018 Quality Payment Program final
rule, MIPS eligible clinicians and groups citing extreme and
uncontrollable circumstances may also apply for a reweighting of the
quality, cost, and/or improvement activities performance categories (82
FR 53783 through 53785). Respondents who apply for a reweighting for
any of these performance categories have the option of applying for
reweighting for the Promoting Interoperability performance category on
the same online form. Since we do not have data on the number of
reweighting applications submitted for the 2018 MIPS performance period
for this rule, we assume that respondents applying for a reweighting of
the Promoting Interoperability performance category due to extreme and
uncontrollable circumstances will also request a reweighting of at
least one of the other performance categories simultaneously and not
submit multiple reweighting applications. As data availability allows,
we will estimate the reporting burden for each reweighting application
under separate ICRs in future rulemaking.
Table 77 summarizes the burden for clinicians to apply for
reweighting the

[[Page 60012]]

Promoting Interoperability performance category to zero percent due to
a significant hardship exception (including a significant hardship
exception for small practices) or as a result of a decertification of
an EHR. Based on the number of reweighting applications received for
the 2017 MIPS performance period, we assume 6,041 respondents (eligible
clinicians or groups) will submit a request to reweight the Promoting
Interoperability performance category to zero percent due to a
significant hardship (including clinicians in small practices) or EHR
decertification. We estimate that 3,344 respondents (eligible
clinicians or groups) will submit a request for reweighting the
Promoting Interoperability performance category to zero percent due to
extreme and uncontrollable circumstances, insufficient internet
connectivity, lack of control over the availability of CEHRT, or as a
result of a decertification of an EHR. An additional 2,697 respondents
will submit a request for reweighting the Promoting Interoperability
performance category to zero percent as a small practice experiencing a
significant hardship. In total, this represents a decrease of 34,604
from the number of respondents currently approved by OMB. In the CY
2019 PFS proposed rule, we lacked the detailed data necessary to
independently estimate the number of reweighting applications submitted
by clinicians in a small practice who were of an eligible clinician
type and are not eligible to have the Promoting Interoperability
performance category reweighted for any other reason (for example,
because they are hospital-based, ASC-based, or non-patient facing), and
therefore, assumed all clinicians in small practices that met these
criteria would apply for reweighting of the Promoting Interoperability
performance category. Data from the 2017 MIPS performance period has
sufficient detail to allow for this analysis, resulting in a decrease
of 78,573 from the estimate of 81,270 clinicians in a small practice
cited in the CY 2019 PFS proposed rule (83 FR 36030).
The total of 6,041 respondents represents a decrease of 34,604 from
the number of respondents currently approved by OMB. The application to
request a reweighting to zero percent only for the Promoting
Interoperability performance category is a short online form that
requires identifying the type of hardship experienced or whether
decertification of an EHR has occurred and a description of how the
circumstances impair the clinician or group's ability to submit
Promoting Interoperability data, as well as some proof of circumstances
beyond the clinician's control. The application for reweighting of the
quality, cost, Promoting Interoperability, and/or improvement
activities performance categories due to extreme and uncontrollable
circumstances requires the same information with the exception of there
being only one option for the type of hardship experienced. We estimate
it will take 0.25 hours at $89.18/hr for a computer system analyst to
submit the application. This is a reduction from the 0.5 hours
estimated in the CY 2018 Quality Payment Program final rule due to a
revised assessment of the application process (82 FR 53918). As shown
in Table 77, in aggregate, we estimate an annual burden of 1,510.25
hours (6,041 applications x 0.25 hr/application) at a cost of $134,684
(1,510.25 hr x $89.18/hr).
Independent of the change to the number of respondents, the
decrease in the amount of time to submit a reweighting application
results in an adjustment of -10,161.25 hours at -$906,180 (40,645
respondents x -0.25 hr x $89.18/hr). Accounting for the decrease in
time per respondent, the decrease in the number of respondents
submitting reweighting applications results in an adjustment of -8,651
hours at -$771,496 (-34,604 respondents x 0.25 hr x $89.18hr). When
these adjustments are combined, the total adjustment is -18,812.25
hours (-10,161.25-8,651) at $1,677,676 (-$906,180-$771,496).

Table 77--Estimated Burden for Reweighting Applications for Promoting
Interoperability and Other Performance Categories
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
# of Eligible Clinicians or Groups Applying Due to 3,344
Significant Hardship and Other Exceptions (a)..........
# of Eligible Clinicians or Groups Applying Due to 2,697
Significant Hardship for Small Practice (b)............
---------------
Total Respondents Due to Hardships, Other Exceptions 6,041
and Hardships for Small Practices (c)..............
---------------
Hours Per Applicant per application submission (d)...... 0.25
---------------
Total Annual Hours (e) = (a) * (c).................. 1,510.25
Labor Rate for a computer systems analyst (f)........... $89.18/hr
---------------
Total Annual Cost (g) = (a) * (f)................... $134,684
------------------------------------------------------------------------

The following is a summary of the public comments received on the
Quality Payment Program ICRs regarding reweighting applications for
Promoting Interoperability and other performance categories:
Comment: One commenter noted that CMS's estimate of 15 minutes to
complete and submit the Promoting Interoperability reweighting
application is low and should be increased to an estimate of between 30
minutes and 1 hour.
Response: We understand that some respondents may require
additional time to submit a reweighting application above the 15
minutes we estimate, but we believe this estimate is a reasonable
average across all respondents as the application process requires
limited basic information about the clinician or submitter, a small
number of check boxes and drop-down selections, and a free text field
to provide justification for the requested application. In addition, we
believe increased familiarity with the process in its second year also
reduces the average time across all respondents.
After consideration of public comments, we are making no changes to
our estimates as a result of public comments received. However, the
burden estimates have been updated from the CY 2019 PFS proposed rule
to reflect availability of data from the 2017 MIPS performance period
(83 FR 36030 through 36031).

[[Page 60013]]

Submitting Promoting Interoperability Data: In this final rule, we
have adjusted the estimated number of respondents based on data from
the 2017 MIPS performance period and the estimated per respondent time
due to the net reduction of 3 measures (6 removed measures and 3 new
measures) for which clinicians are required to submit data, which we
are finalizing as discussed in section III.I.3.h.(5)(f) of this final
rule.
A variety of organizations will submit Promoting Interoperability
data on behalf of clinicians. Clinicians not participating in a MIPS
APM may submit data as individuals or as part of a group. In the CY
2017 Quality Payment Program final rule (81 FR 77258 through 77260,
77262 through 77264), we established that eligible clinicians in MIPS
APMS other than the Shared Savings Program may submit data for the
Promoting Interoperability performance category as individuals or as
part of a group, whereas eligible clinicians participating in the
Shared Savings Program are limited to submitting data through the ACO
participant TIN. In section III.I.3.h.(6)(d)(ii) of this final rule, we
are finalizing our proposal to extend this flexibility to allow for
both individual and group reporting by eligible clinicians
participating in the Shared Savings Program.
As shown in Table 78, based on data from the 2017 MIPS performance
period, we estimate that a total of 93,933 respondents consisting of
81,456 individual MIPS eligible clinicians and 12,413 groups will
submit Promoting Interoperability data. Similar to the process shown in
Table 66 for groups reporting via QCDR/MIPS CQM and eCQM collection
types, we have adjusted the group reporting data from the 2017 MIPS
performance period to account for virtual groups, as the option to
submit data as a virtual group was not available until the 2018 MIPS
performance period. These estimates reflect that under the policies in
the CY 2017 Quality Payment Program final rule and in the CY 2018
Quality Payment Program final rule, certain MIPS eligible clinicians
will be eligible for automatic reweighting of the Promoting
Interoperability performance category to zero percent, including MIPS
eligible clinicians that are hospital-based, ambulatory surgical
center-based, non-patient facing clinicians, physician assistants,
nurse practitioners, clinician nurse specialists, and certified
registered nurse anesthetists (81 FR 77238 through 77245 and 82 FR
53680 through 53687). As discussed in section III.I.3.h.(5)(h)(ii) of
this final rule, starting with the 2021 MIPS payment year, we are
finalizing a policy to automatically reweight the Promoting
Interoperability performance category for clinician types new to MIPS:
Physical therapists; occupational therapists; qualified speech-language
pathologists or qualified audiologist; clinical psychologists; and
registered dieticians or nutrition professionals. These estimates also
account for the reweighting policies finalized in the CY 2017 and CY
2018 Quality Payment Program final rules, including exceptions for MIPS
eligible clinicians who have experienced a significant hardship
(including clinicians who are in small practices), as well as
exceptions due to decertification of an EHR.
Further, we assume that Shared Savings Program Track 1 ACOs will
submit data at the ACO participant TIN-level, APM Entities electing the
one-sided track in the CEC model will submit data at the group TIN-
level, and APM Entities in the OCM (one-sided risk arrangement) will
submit data at APM Entity level; these entities are included in our
estimate of the number of groups submitting data. Our respondent
estimate is based on existing data and does not consider policies
finalized in section V of this final rule, as well as additional
policies that were proposed in the August 2018 proposed rule and may be
finalized in a future rule, which may change the number of Shared
Saving Program ACOs that are required to submit Promoting
Interoperability data for future years.\45\
---------------------------------------------------------------------------

\45\ https://www.gpo.gov/fdsys/pkg/FR-2018-08-17/pdf/2018-17101.pdf.

Table 78--Estimated Number of Respondents To Submit Promoting
Interoperability Performance Data on Behalf of Clinicians
------------------------------------------------------------------------
Number of
respondents
------------------------------------------------------------------------
Number of individual clinicians to submit Promoting 81,456
Interoperability (a)...................................
Number of groups to submit Promoting Interoperability(b) 12,477
Subtract: Number of groups to submit Promoting 80
Interoperability on behalf of clinicians in Quality
Payment Program Year 3 that will submit as virtual
groups in Quality Payment Program Year 3 (c)...........
Add in: Number of virtual groups to submit Promoting 16
Interoperability on behalf of clinicians in Quality
Payment Program Year 3 (d).............................
Number of groups to submit Promoting Interoperability on 12,413
behalf of clinicians in Quality Payment Program Year 3
(e) = (b)-(c) + (d)....................................
---------------
Total (f) = (a) + (e)............................... 93,869
------------------------------------------------------------------------

In the CY 2018 Quality Payment Program final rule, we estimated it
takes 3 hours for a computer system analyst to collect and submit
Promoting Interoperability performance category data (82 FR 53920). For
this final rule, we estimate the time required to submit such data
should be reduced by 20 minutes to 2.67 hours due to the reduction in
the number of measures for which clinicians are required to submit
data, which we are finalizing as discussed in section III.I.3.h.(5)(f)
of this final rule. As shown in Table 78, the total time for an
organization to submit data on the specified Promoting Interoperability
objectives and measures is estimated to be 250,317 hours (93,869
respondents x 2.67 incremental hours for a computer analyst's time
above and beyond the clinician, practice manager, and computer system's
analyst time required to submit quality data) at a cost of $22,323,300
(250,317 hr x $89.18/hr).
Independent of the change in the number of respondents, the
reduction in estimated time to submit Promoting Interoperability data
results in a decrease in burden of -72,738.33 hours at -$6,486,805
(218,215 respondents x -0.33 hr x $89.18/hr). Accounting for the
decreased per respondent time, the decrease in the number of
respondents

[[Page 60014]]

results in an adjustment to the total burden of -331,589.33 hours at -
$29,571,137 (-124,346 respondents x 2.67 hrs x $89.18/hr). When these
adjustments are combined, the total adjustment is -404,327.67 hours (-
72,738.33 -331,589.33) at -$36,057,941 (-$6,486,805 -$29,571,137).

Table 79--Estimated Burden for Promoting Interoperability Performance
Category Data Submission
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
Number of individual clinicians to submit Promoting 81,456
Interoperability (a)...................................
Number of groups to submit Promoting Interoperability 12,413
(b)....................................................
---------------
Total (c) = (a) + (b)............................... 93,869
---------------
Total Annual Hours Per Respondent (b)............... 2.67
---------------
Total Annual Hours (c) = (a) * (b)...................... 250,317
---------------
Labor rate for a computer systems analyst to submit $89.18/hr
Promoting Interoperability data/hr.) (d)...............
---------------
Total Annual Cost (e) = (a) * (d)................... $22,323,300
------------------------------------------------------------------------

The following is a summary of the public comments received on the
Quality Payment Program ICRs regarding Promoting Interoperability Data:
Comment: One commenter noted that CMS should consider and reduce
the operational burden imposed on clinicians and medical practice staff
by the required measures and reporting processes associated with the
Quality Payment Program specifically and all quality reporting programs
in general. The commenter cited the 20 minute reduction in burden
associated with the proposed reduction in Promoting Interoperability
measures as evidence of its belief that reducing the number of measures
is not enough to reduce the total burden on respondents. The commenter
also noted its belief that frustration and clinician burnout are
increased due to the documentation requirements and workflow
modifications associated with quality reporting programs.
Response: We thank the commenter for its input. We recognize there
is additional burden on clinicians and practice staff beyond the
reporting burden estimated in the Collection of Information section of
this policy which only accounts for the time required for record
keeping, reporting, and third-party disclosures associated with the
policy. CMS does consider the operational burden imposed on clinicians
and practice staff and weighs it against the goal of improving quality
of care prior to finalizing policy decisions. On balance, we believe
that any potential additional burden is outweighed by increased quality
and improved patient outcomes. We will continue to monitor this balance
and will continue to propose efficiencies and policies that will help
to further reduce burden.
After consideration of public comments, we are making no changes to
our estimates as a result of public comments received. However, the
burden estimates have been updated from the CY 2019 PFS proposed rule
to reflect availability of data from the 2017 MIPS performance period
(83 FR 36031 through 36032).
11. Quality Payment Program ICRs Regarding the Nomination of Promoting
Interoperability (PI) Measures
This rule does not include any new or revised reporting,
recordkeeping, or third-party disclosure requirements related to the
nomination of Promoting Interoperability measures. However, we have
adjusted our currently approved burden estimates based data from the
2017 MIPS performance period. The adjusted burden will be submitted to
OMB for approval under control number 0938-1314 (CMS-10621).
Consistent with our requests for stakeholder input on quality
measures and improvement activities, we also request potential measures
for the Promoting Interoperability performance category that measure
patient outcomes, emphasize patient safety, support improvement
activities and the quality performance category, and build on the
advanced use of CEHRT using 2015 Edition standards and certification
criteria. Promoting Interoperability measures may be submitted via a
designated submission form that includes the measure description,
measure type (if applicable), reporting requirement, and CEHRT
functionality used (if applicable).
We estimate 47 organizations will submit Promoting Interoperability
measures, based on the number of organizations submitting measures
during the CY 2017 nomination period. This is an increase of 7 from the
estimate currently approved by OMB under the aforementioned control
number. We estimate it will take 0.5 hours per organization to submit
an activity to us, consisting of 0.3 hours at $107.38/hr for a practice
administrator to make a strategic decision to nominate that activity
and submit an activity to us via email and 0.2 hours at $206.44/hr for
a clinician to review the nomination. As shown in Table 80, in
aggregate, we estimate an annual burden of 235 hours (47 organizations
x 0.5 hr/response) at a cost of $3,455 (47 x [(0.3 h x $107.38/hr) +
(0.2 hr x $206.44/hr)]. The increase in the number of respondents
results in an adjustment of 3.5 hours and $514.50 (7 respondents x 0.5
hrs x $73.50 per respondent).

Table 80--Estimated Burden for Call for Promoting Interoperability
Measures
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
# of Organizations Nominating New Promoting 47
Interoperability Measures (a)..........................
# of Hours Per Practice Administrator to Identify and 0.30
Propose Measure (b)....................................
# of Hours Per Clinician to Identify Measure (c)........ 0.20

[[Page 60015]]

Annual Hours Per Respondent (d) = (b) + (c)............. 0.50
---------------
Total Annual Hours (e) = (a) * (d).................. 23.50
---------------
Cost to Identify and Submit Measure (@practice $32.21
administrator's labor rate of $107.38/hr.) (f).........
Cost to Identify Improvement Measure (@physician's labor $41.29
rate of $206.44/hr.) (g)...............................
---------------
Total Annual Cost Per Respondent (h) = (f) + (g).... $73.50
Total Annual Cost (i) = (a) * (h)................... $3,455
------------------------------------------------------------------------

We received no public comments related to the burden estimates for
the Call for Promoting Interoperability Measures. The burden estimates
have not been updated from the CY 2019 PFS proposed rule (83 FR 36032
through 36033).
12. Quality Payment Program ICRs Regarding Improvement Activities
Submission (Sec. Sec. 414.1305, 414.1355, 414.1360, and 414.1365)
This rule does not include any new or revised reporting,
recordkeeping, or third-party disclosure requirements related to the
submission of Improvement Activities data. However, we have adjusted
our currently approved burden estimates based on more recent data. The
adjusted burden will be submitted to OMB for approval under control
number 0938-1314 (CMS-10621).
We refer readers to the CY 2017 Quality Payment Program final rule
(81 FR 77511 through 77512) and the CY 2018 Quality Payment Program
final rule (82 FR 53920 through 53922) for our previous burden
estimates for improvement activities under the Quality Payment Program.
The CY 2018 Quality Payment Program final rule provides: (1) That
for activities that are performed for at least a continuous 90 days
during the performance period, MIPS eligible clinicians must submit a
``yes'' response for activities within the Improvement Activities
Inventory (82 FR 53651); (2) that the term ``recognized'' is accepted
as equivalent to the term ``certified'' when referring to the
requirements for a patient-centered medical home to receive full credit
for the improvement activities performance category for MIPS (82 FR
53649); and (3) that for the 2020 MIPS payment year and future years,
to receive full credit as a certified or recognized patient-centered
medical home or comparable specialty practice, at least 50 percent of
the practice sites within the TIN must be recognized as a patient-
centered medical home or comparable specialty practice (82 FR 53655).
In the CY 2017 Quality Payment Program final rule, we describe how
we determine MIPS APM scores (81 FR 77185). We compare the requirements
of the specific MIPS APM with the list of activities in the Improvement
Activities Inventory and score those activities in the same manner that
they are otherwise scored for MIPS eligible clinicians (81 FR 77817
through 77831). If, by our assessment, the MIPS APM does not receive
the maximum improvement activities performance category score, then the
APM Entity can submit additional improvement activities, although, as
we noted, we anticipate that MIPS APMs in the 2019 MIPS performance
period will not need to submit additional improvement activities as the
models will already meet the maximum improvement activities performance
category score (81 FR 77185).
A variety of organizations and in some cases, individual
clinicians, will submit improvement activity performance category data.
For clinicians who are not part of APMs, we assume that clinicians
submitting quality data as part of a group through direct, log in and
upload submission types, and CMS Web Interface will also submit
improvement activities data. As finalized in the CY 2017 Quality
Payment Program final rule (81 FR 77264), APM Entities only need to
report improvement activities data if the CMS-assigned improvement
activities score is below the maximum improvement activities score. Our
CY 2018 Quality Payment Program final rule burden estimates assumed
that all APM Entities will receive the maximum CMS-assigned improvement
activities score (82 FR 53921 through 53922).
As represented in Table 81, based on 2017 MIPS performance period
data, we estimate that 125,713 clinicians will submit improvement
activities as individuals during the 2019 MIPS performance period and
16,478 groups will submit improvement activities on behalf of
clinicians. Similar to the process shown in Table 77 for groups
submitting Promoting Interoperability data, we have adjusted the group
reporting data from the 2017 MIPS performance period to account for
virtual groups, as the option to submit data as a virtual group was not
available until the 2018 MIPS performance period.
Our burden estimates assume there will be no improvement activities
burden for MIPS APM participants. We will assign the improvement
activities performance category score at the APM level. We also assume
that the MIPS APM models for the 2019 MIPS performance period will
qualify for the maximum improvement activities performance category
score and the APM Entities will not need to submit any additional
improvement activities.

[[Page 60016]]

[GRAPHIC] [TIFF OMITTED] TR23NO18.078

As described in section III.I.3.h.(4)(b) of this final rule, for
purposes of the 2021 MIPS payment year, we have finalized Sec.
414.1360(a)(1) to more accurately reflect the data submission process
for the improvement activities performance category. In particular,
instead of ``via qualified registries; EHR submission mechanisms; QCDR,
CMS Web Interface; or attestation,'' as currently stated, we have
revised the first sentence to state that data will be submitted ``via
direct, log in and upload, and log in and attest.'' The revision will
more closely align with the actual submission experience users have.
In the CY 2018 Quality Payment Program final rule, we estimated it
would take 1 hour for a computer system analyst to submit data on the
specified improvement activities (82 FR 53922). We are finalizing to
decrease this burden estimate since the actual submission experience of
the user is such that improvement activities data is submitted as part
of the process for submitting quality and Promoting Interoperability
data, resulting in less additional required time to submit improvement
activities data. As a result, we estimate that the per response time
required per individual or group is 5 minutes at $89.18/hr for a
computer system analyst to submit by logging in and manually attesting
that certain activities were performed in the form and manner specified
by CMS with a set of authenticated credentials. Additionally, as stated
in the CY 2018 Quality Payment Program final rule, the same improvement
activity may be reported across multiple performance periods so many
MIPS eligible clinicians will not have any additional information to
submit for the 2019 MIPS performance period (82 FR 53921).
As discussed in section III.I.3.h.(4)(d)(ii) of this final rule, we
are also finalizing for CY 2019 and future years to: Add 6 new
improvement activities; modify 5 existing improvement activities; and
remove 1 existing improvement activity. Because MIPS eligible
clinicians are still required to submit the same number of activities,
we do not expect these provisions to affect our collection of
information burden estimates. In addition, in order for an eligible
clinician or group to receive credit for being a patient-centered
medical home or comparable specialty practice, the eligible clinician
or group must attest in the same manner as any other improvement
activity.
As shown in Table 82, we estimate an annual burden of 11,333.7
hours (136,004 responses x 5 minutes/60) at a cost of $1,010,736
(11,333.7 hr x $89.18/hr).
Independent of the change to our per response time estimate, the
decrease in the number of respondents results in an adjustment of -
303,782 hours at -$27,091,279 (-303,782 respondents x 1 hr x $89.18/
hr). Accounting for the change in number of respondents, the decrease
in the time to submit improvement activities data results in an
adjustment of -124,670.33 hours at -$11,118,100.33 (136,004 respondents
x 55 minutes/60 x $89.18/hr). When these adjustments are combined, the
total adjustment is -428,452.33 hours (-303,782-124,670.33) hours at -
$38,209,379.33 (-$27,091,279-$11,118,100.33).

Table 82--Estimated Burden for Improvement Activities Submission
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
Total Number of Respondents (Groups, Virtual Groups, and 136,004
Individual Clinicians) to submit improvement activities
data on behalf of clinicians during the 2019 MIPS
performance period (a).................................
Total Annual Hours Per Respondent (b)................... 5 minutes
Total Annual Hours (c).............................. 11,333.7
Labor rate for a computer systems analyst to submit $89.18/hr
improvement activities (d).............................
---------------
Total Annual Cost (e) = (a) * (d)................... $1,010,736
------------------------------------------------------------------------

[[Page 60017]]

The following is a summary of the public comments received on the
Quality Payment Program ICRs regarding Improvement Activities
Submission:
Comment: One commenter noted that CMS's estimate of 5 minutes to
submit data for the Improvement Activities performance category is low
and should be increased to an estimate of between 15 and 30 minutes.
Response: We thank the commenter for its input. We understand that
some respondents may require additional time to submit improvement
activities data above the 5 minutes we estimate, but we believe this
estimate is a reasonable average across all respondents as it reflects
the actual submission experience of the user. User experiences from the
2017 MIPS performance period reflect that the majority of users submit
improvement activities data as part of the login and upload or direct
submission types which allow multiple performance categories (i.e.,
quality and promoting interoperability) worth of data to be submitted
at once. This results in less additional required time to submit
improvement activities data which consists of manually attesting that
certain activities were performed. In addition, as previously stated in
the CY 2018 Quality Payment Program final rule, the same improvement
activity may be reported across multiple performance periods so many
MIPS eligible clinicians will not have any additional information to
submit for the 2019 MIPS performance period, further reducing the
average time spent reporting improvement activities data across all
MIPS eligible clinicians (82 FR 53921).
After consideration of public comments, we are making no changes to
our estimates as a result of public comments received. However, the
burden estimates have been updated from the CY 2019 PFS proposed rule
to reflect availability of data from the 2017 MIPS performance period
(83 FR 36033 through 36034).
13. Quality Payment Program ICRs Regarding the Nomination of
Improvement Activities (Sec. 414.1360)
The finalized requirements and burden discussed under this section
will be submitted to OMB for approval under control number 0938-1314
(CMS-10621). We refer readers to the CY 2018 Quality Payment Program
final rule for our previous burden estimates for nomination of
improvement activities under the Quality Payment Program (82 FR 53922).
In this final rule, we have adjusted the number of respondents based on
more recent data and adjusted our per response time estimate based on
our review of our currently approved burden estimates against the
existing process for nomination of improvement activities. As discussed
in section III.I.3.h.(4)(d)(i)(A) of this final rule, we are also
finalizing to adopt one new criteria and remove one existing criteria
for nominating new improvement activities beginning with the CY 2019
performance period and future years. Furthermore, we have made
clarifications to: (1) Considerations for selecting improvement
activities for the CY 2019 performance period and future years; and (2)
the weighting of improvement activities. We believe these policy
changes will not affect our currently approved burden estimates since
they do not substantively impact the level of effort previously
estimated to nominate an Improvement Activity.
As discussed in section III.I.3.h.(4)(d)(i)(D) of this final rule,
we are finalizing changing the performance year for which the
nominations will apply, such that improvement activities nominations
received in a particular year will be vetted and considered for the
next year's rulemaking cycle for possible implementation in the
following year. Also, as discussed in section III.I.3.h.(4)(d)(i)(D) of
this final rule, we are finalizing changing the submission timeframe
for the Call for Activities from February 1st through March 1st to
February 1st through June 30th, providing approximately four additional
months for stakeholders to submit nominations. We believe these policy
changes will not affect our currently approved burden estimates since
we believe that the number of nominations is unlikely to change, but
the quality of the nominations is likely to increase given the
additional time provided.
For the 2018 MIPS performance period, we provided opportunity for
stakeholders to propose new activities formally via the Annual Call for
Activities nomination form that was posted on the CMS website (82 FR
53657). The 2018 Annual Call for Activities lasted from March 2, 2017
through March 1, 2018, for which we received 72 nominations consisting
of a total of 125 activities which were evaluated for the Improvement
Activities Under Consideration (IAUC) list for possible inclusion in
the CY 2019 Improvement Activities Inventory. Based on the number of
activities being evaluated during the 2018 Annual Call for Activities
(125 activities), we estimate that the total number of nominations we
will receive for the 2019 Annual Call for Activities will continue to
be 125, unchanged from the number of activities evaluated in CY 2018,
which is a decrease from the 150 nominations currently approved by OMB.
In the CY 2018 Quality Payment Program final rule, we estimated
that it takes 0.5 hours to nominate an improvement activity (82 FR
53922). As shown in Table 83, due to a review of the nomination process
including the criteria required to nominate an improvement activity, we
now estimate it will take 2 hours (per organization) to submit an
activity to us. Of those hours, we estimate it will take 1.2 hours at
$107.38/hr for a practice administrator or equivalent to make a
strategic decision to nominate and submit that activity and 0.8 hours
at $206.44/hr for a clinician's review. In aggregate, we estimate an
annual burden of 250 hours (125 nominations x 2 hr/nomination) at a
cost of $36,751 (125 x [(1.2 hr x $107.38/hr) + (0.8 hr x $206.44/
hr)]).
The percentage of practice administrator and clinician labor in
relation to the total is unchanged from the CY 2018 Quality Payment
Program final rule (82 FR 53922).
Independent of the change to our per response time estimate, the
decrease in the number of nominations results in an adjustment of -12.5
hours and -$1,837 (-25 activities x [(0.3 hr x $107.38/hr) + (0.2 hr x
$206.44/hr)]). Accounting for the decrease in the number of nominated
improvement activities, the increase in time per nominated improvement
activity results in an adjustment of 187.5 hours and $27,563 (125
activities x [(0.9 hr x $107.38/hr) + (0.6 hr x $206.44/hr)]). When
these adjustments are combined, the total adjustment is 175 hours
(187.5-12.5) and $25,726 ($27,563-$1,837).

[[Page 60018]]

Table 83--Estimated Burden for Nomination of Improvement Activities
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
Number of Organizations Nominating New Improvement 125
Activities (a).........................................
Number of Hours Per Practice Administrator to Identify 1.2
and Propose Activity (b)...............................
Number of Hours Per Clinician to Identify Activity (c).. 0.8
---------------
Annual Hours Per Respondent (d) = (b) + (c)............. 2
---------------
Total Annual Hours (e) = (a) * (d).................. 250
---------------
Cost to Identify and Submit Activity (@practice $128.86
administrator's labor rate of $107.38/hr.) (f).........
Cost to Identify Improvement Activity (@physician's $165.15
labor rate of $206.44/hr.) (g).........................
Total Annual Cost Per Respondent (h) = (f) + (g)........ $294.01
---------------
Total Annual Cost (i) = (a) * (h)................... $36,751
------------------------------------------------------------------------

The following is a summary of the public comments received on the
Quality Payment Program ICRs regarding Improvement Activities
Submission:
Comment: One commenter noted that the burden estimate of 2 hours
for nomination of Improvement Activities is low due to the time needed
by clinicians and their staff to assess a need in their practice
situation, formulate a creative solution, and determine how they would
implement it in their practice in addition to documenting and
submitting the improvement activity to CMS.
Response: We recognize there is additional burden on respondents
associated with development of a new improvement activity beyond the
reporting burden estimated in the Collection of Information section of
this policy which only accounts for the time required for record
keeping, reporting, and third-party disclosures associated with the
policy. We understand that some respondents may require additional time
above the 2 hours we estimate for completing the process for nominating
an improvement activity, but given that we do not include development
of an improvement activity in our burden estimate, we believe this
estimate is a reasonable average across all respondents based on our
review of the nomination process, the information required to complete
the nomination form, and the criteria required to nominate an
improvement activity.
After consideration of public comments, we are making no changes to
our estimates as a result of public comments received. The burden
estimates have not been updated from the CY 2019 PFS proposed rule (83
FR 36034 through 36035).
14. Quality Payment Program ICRs Regarding CMS Study on Factors
Associated With Reporting Quality Measures
During each performance year, eligible clinicians are recruited to
participate in the CMS study on the burden associated with reporting
quality measures. Eligible clinicians who are interested in
participating can sign up whereby an adequate sample size is then
selected by CMS from this group of potential participants. This study
is ongoing, and participants are recruited on a yearly basis. Current
participants can sign up when the study year ends.
Section 1848(s)(7) of the Act, as added by section 102 of the MACRA
(Pub. L. 114-10) states that Chapter 35 of title 44, United States
Code, shall not apply to the collection of information for the
development of quality measures. Consequently, we are not setting out
such burden since the study shall inform us (and our contractors) on
the root causes of clinicians' performance measure data collection and
data submission burdens and challenges that hinders accurate and timely
quality measurement activities. We refer readers to the discussion of
this policy in section VII.F.7 of this final rule.
15. Quality Payment Program ICRs Regarding the Cost Performance
Category (Sec. 414.1350)
The cost performance category relies on administrative claims data.
The Medicare Parts A and B claims submission process (OMB control
number 0938-1197) is used to collect data on cost measures from MIPS
eligible clinicians. MIPS eligible clinicians are not required to
provide any documentation by CD or hardcopy. Moreover, the provisions
of this final rule do not result in the need to add or revise or delete
any claims data fields. Therefore, we do not anticipate any new or
additional submission requirements and/or burden for MIPS eligible
clinicians resulting from the cost performance category.
We received no public comments related to burden for the cost
performance category.
16. Quality Payment Program ICRs Regarding Partial QP Elections (Sec.
414.1430)
This rule does not include any new or revised reporting,
recordkeeping, or third-party disclosure requirements related to QP
elections. However, we have adjusted our currently approved burden
estimates based on more recent data. The adjusted burden will be
submitted to OMB for approval under control number 0938-1314 (CMS-
10621).
APM Entities may face a data submission burden under MIPS related
to Partial QP elections. Advanced APM participants will be notified
about their QP or Partial QP status as soon as possible after each QP
determination. Where Partial QP status is earned at the APM Entity
level, the burden of Partial QP election will be incurred by a
representative of the participating APM Entity. Where Partial QP status
is earned at the eligible clinician level, the burden of Partial QP
election will be incurred by the eligible clinician. For the purposes
of this burden estimate, we assume that all MIPS eligible clinicians
determined to be Partial QPs will participate in MIPS.
Based on our predictive QP analysis for the 2019 QP performance
period, we estimate that 6 APM Entities and 75 eligible clinicians will
make the election to participate as a Partial QP in MIPS (see Table
84), an increase of 64 from the 17 elections currently approved by OMB
under the aforementioned control number. We estimate it will take the
APM Entity representative or eligible clinician 15 minutes (0.25 hr) to
make this election. In aggregate, we estimate

[[Page 60019]]

an annual burden of 20.25 hours (81 respondents x .25 hr/election) at a
cost of $1,805.90 (20.25 hours x $89.18/hr). The increase in the number
of Partial QP elections results in an adjustment of 16 hours and $1,431
(64 elections x 0.25 hrs x $89.18/hr).

Table 84--Estimated Burden for Partial QP Election
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
Number of respondents making Partial QP election (6 APM 81
Entities, 75 eligible clinicians) (a)..................
Total Hours Per Respondent to Elect to Participate as 0.25 hours
Partial QP (b).........................................
Total Annual Hours (c) = (a) * (b)...................... 20.25 hours
Labor rate for computer systems analyst (d)............. $89.18/hr
---------------
Total Annual Cost (d) = (c) * (d)................... $1,805.90
------------------------------------------------------------------------

We received no public comments related to the burden estimates for
Partial QP Election. The burden estimates have not been updated from
the CY 2019 PFS proposed rule (83 FR 36036).
17. Quality Payment Program ICRs Regarding Other Payer Advanced APM
Determinations: Payer-Initiated Process (Sec. 414.1440) and Eligible
Clinician Initiated Process (Sec. 414.1445)
As indicated below, the finalized requirements and burden discussed
under this section will be submitted to OMB for approval under control
number 0938-1314 (CMS-10621).
Payer Initiated Process (Sec. 414.1440): This rule does not
include any new or revised reporting, recordkeeping, or third-party
disclosure requirements related to the Payer Initiated Process.
However, we have adjusted our currently approved burden estimates based
on more recent data. The adjusted burden will be submitted to OMB for
approval under control number 0938-1314 (CMS-10621).
Beginning in Quality Payment Program Year 3, the All-Payer
Combination Option will be an available pathway to QP status for
eligible clinicians participating sufficiently in Advanced APMs and
Other Payer Advanced APMs. The All-Payer Combination Option allows for
eligible clinicians to achieve QP status through their participation in
both Advanced APMs and Other Payer Advanced APMs. In order to include
an eligible clinician's participation in Other Payer Advanced APMs in
their QP threshold score, we will need to determine if certain payment
arrangements with other payers meet the criteria to be Other Payer
Advanced APMs. To provide eligible clinicians with advance notice prior
to the start of a given performance period, and to allow other payers
to be involved prospectively in the process, the 2018 CY Quality
Payment Program final rule established a payer-initiated process for
identifying payment arrangements that qualify as Other Payer Advanced
APMs (82 FR 53844). The payer-initiated process for Other Payer
Advanced APM determinations began in CY 2018 for Medicaid, Medicare
Health Plans, and payers participating in CMS multi-payer models.
Payers seeking to submit payment arrangement information for Other
Payer Advanced APM determination through the payer-initiated process
are required to complete a Payer Initiated Submission Form,
instructions for which is available at https://qpp.cms.gov/.
Determinations made in 2018 are applicable for the Quality Payment
Program Year 3.
Also in the CY 2018 Quality Payment Program final rule we
established our intent to finalize that the remaining other payers,
including commercial and other private payers, may request that we
determine whether other payer arrangements are Other Payer Advanced
APMs starting prior to the 2020 QP performance period and each
performance period thereafter (82 FR 53867). As a result, in this final
rule, we finalized our proposal to eliminate the Payer Initiated
Process that is specifically for CMS Multi-Payer Models. We believe
that payers aligned with CMS Multi-Payer Models can submit their
arrangements through the Payer Initiated Process for Remaining Other
Payers in section III.I.4.e.(4)(c) of this final rule, or through the
Medicaid or Medicare Health Plan payment arrangement submission
processes.
As shown in Table 85, we estimate that in 2019 for the 2020 QP
performance period 215 payer-initiated requests for Other Payer
Advanced APM determinations will be submitted (15 Medicaid payers, 100
Medicare Advantage Organizations, and 100 remaining other payers), a
decrease of 85 from the 300 total requests currently approved by OMB
under the aforementioned control number. We estimate it will take 10
hours at $89.18/hr for a computer system analyst per arrangement
submission. In aggregate, we estimate an annual burden of 2,150 hours
(215 submissions x 10 hr/submission) at a cost of $191,737 (2,150 hr x
$89.18/hr). The decrease in the number of payer-initiated requests
results in an adjustment of -850 hours and -$75,803 (-85 requests x 10
hr x $89.18/hr).

Table 85--Estimated Burden for Other Payer Advanced APM Identification
Determinations: Payer-Initiated Process
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
Number of other payer payment arrangements (15 Medicaid, 215
100 Medicare Advantage Organizations, 100 remaining
other payers) (a)......................................
Total Annual Hours Per other payer payment arrangement 10
(b)....................................................
---------------
Total Annual Hours (c) = (a) * (b).................. 2,150
---------------
Labor rate for a computer systems analyst (d)........... $89.18/hr
---------------

[[Page 60020]]

Total Annual Cost for Other Payer Advanced APM $191,737
determinations (e) = (a) * (d).....................
------------------------------------------------------------------------

We received no public comments related to the burden estimates for
Other Payer Advanced APM Identification Determinations: Payer-Initiated
Process. The burden estimates have been updated from the CY 2019 PFS
proposed rule to reflect updated respondent estimates (83 FR 36036
through 36037).
Eligible Clinician Initiated Process (Sec. 414.1445): This rule
does not include any new or revised reporting, recordkeeping, or third-
party disclosure requirements related to the Eligible Clinician
Initiated Process. However, we have adjusted our currently approved
burden estimates based on more recent data. The adjusted burden will be
submitted to OMB for approval under control number 0938-1314 (CMS-
10621).
Beginning in Quality Payment Program Year 3, the All-Payer
Combination Option will be an available pathway to QP status for
eligible clinicians participating sufficiently in Advanced APMs and
Other Payer Advanced APMs. The All-Payer Combination Option allows for
eligible clinicians to achieve QP status through their participation in
both Advanced APMs and Other Payer Advanced APMs. In order to include
an eligible clinician's participation in Other Payer Advanced APMs in
their QP threshold score, we will need to determine if certain payment
arrangements with other payers meet the criteria to be Other Payer
Advanced APMs. To provide eligible clinicians with advanced notice
prior to the start of a given performance period, and to allow other
payers to be involved prospectively in the process, the CY 2018 Quality
Payment Program final rule provided a payer-initiated identification
process for identifying payment arrangements that qualify as Other
Payer Advanced APMs (82 FR 53854). In the same rule, under the Eligible
Clinician Initiated Process, APM Entities and eligible clinicians
participating in other payer arrangements will have an opportunity to
request that we determine for the year whether those other payer
arrangements are Other Payer Advanced APMs (82 FR 53857--53858).
However, to appropriately implement the statutory requirement to
exclude from the All Payer Combination Option QP threshold calculations
certain Title XIX payments and patients, we determined it will be
problematic to allow APM Entities and eligible clinicians to request
determinations for Title XIX payment arrangements after the conclusion
of the QP performance period because any late-identified Medicaid APM
or Medicaid Medical Home Model that meets the Other Payer Advanced APM
criteria could unexpectedly affect QP threshold calculations for every
other clinician in that state (or county). Thus, the CY 2018 Quality
Payment Program final rule provided that APM Entities and eligible
clinicians may request determinations for any Medicaid payment
arrangements in which they are participating at an earlier point, prior
to the start of a given QP performance period (82 FR 53858). This will
allow all clinicians in a given state or county to know before the
beginning of the performance period whether their Title XIX payments
and patients will be excluded from the all-payer calculations that are
used for QP determinations for the year under the All-Payer Combination
Option. This Medicaid specific eligible clinician-initiated
determination process for Other Payer Advanced APMs also began in CY
2018, and determinations made in 2018 are applicable for the Quality
Payment Program Year 3. Eligible clinicians or APM Entities seeking to
submit payment arrangement information for Other Payer Advanced APM
determination through the Eligible Clinician-Initiated process are
required to complete an Eligible Clinician Initiated Submission Form,
instructions for which is available at https://qpp.cms.gov/.
As shown in Table 86, we estimate that 150 other payer arrangements
will be submitted by APM Entities and eligible Other Payer Advanced APM
determinations, an increase of 75 from the 75 total requests currently
approved by OMB under the aforementioned control number.
We estimate it will take 10 hours at $89.18/hr for a computer
system analyst per arrangement submission to submit this data. In
aggregate, we estimate an annual burden of 1,500 hours (150 submissions
x 10 hr/submission) at a cost of $133,770 (1,500 hr x $89.18/hr). The
increase in the number of clinician-initiated requests results in an
adjustment of 750 hours and $66,885 (75 requests x 10 hr x $89.18/hr).

Table 86--Estimated Burden for Other Payer Advanced APM Determinations:
Eligible Clinician Initiated Process
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
Number of other payer payment arrangements from APM 150
Entities and eligible clinicians.......................
Total Annual Hours Per other payer payment arrangement 10
(b)....................................................
---------------
Total Annual Hours (c) = (a) * (b).................. 1,500
---------------
Labor rate for a computer systems analyst (d)........... $89.18/hr
---------------
Estimated Total Annual Cost for Other Payer Advanced $133,770
APM determinations (e) = (a) * (d).................
------------------------------------------------------------------------

We received no public comments related to the burden estimates for
Other Payer Advanced APM Identification Determinations: Eligible
Clinician Initiated Process. The burden estimates have not been updated
from the CY

[[Page 60021]]

2019 PFS proposed rule (83 FR 36037 through 36038).
Submission of Data for QP Determinations under the All-Payer
Combination Option (Sec. 414.1440): The following reflects the burden
associated with the first year of data collection resulting from
policies set out in the CY 2018 Quality Payment Program final rule.
Because no collection of data was required prior to the CY 2019
performance period, the requirements and burden were not submitted to
OMB for approval. However, by virtue of this rulemaking, the
requirements and burden will be submitted to OMB for approval under
control number 0938-1314 (CMS-10621).
The CY 2017 Quality Payment Program final rule provided that either
APM Entities or individual eligible clinicians must submit by a date
and in a manner determined by us: (1) Payment arrangement information
necessary to assess whether each other payer arrangement is an Other
Payer Advanced APM, including information on financial risk
arrangements, use of CEHRT, and payment tied to quality measures; (2)
for each payment arrangement, the amounts of payments for services
furnished through the arrangement, the total payments from the payer,
the numbers of patients furnished any service through the arrangement
(that is, patients for whom the eligible clinician is at risk if actual
expenditures exceed expected expenditures), and (3) the total number of
patients furnished any service through the arrangement (81 FR 77480).
The rule also specified that if we do not receive sufficient
information to complete our evaluation of another payer arrangement and
to make QP determinations for an eligible clinician using the All-Payer
Combination Option, we will not assess the eligible clinicians under
the All-Payer Combination Option (81 FR 77480).
In the CY 2018 Quality Payment Program final rule, we explained
that in order for us to make QP determinations under the All-Payer
Combination Option using either the payment amount or patient count
method, we will need to receive all of the payment amount and patient
count information: (1) Attributable to the eligible clinician or APM
Entity through every Other Payer Advanced APM; and (2) for all other
payments or patients, except from excluded payers, made or attributed
to the eligible clinician during the QP performance period (82 FR
53885). We also finalized that eligible clinicians and APM Entities
will not need to submit Medicare payment or patient information for QP
determinations under the All-Payer Combination Option (82 FR 53885).
The CY 2018 Quality Payment Program final rule noted that we will
need this payment amount and patient count information for the periods
January 1 through March 31, January 1 through June 30, and January 1
through August 31 (82 FR 53885). We noted that the timing may be
challenging for APM Entities or eligible clinicians to submit
information for the August 31 snapshot date. If we receive information
for either the March 31 or June 30 snapshots, but not the August 31
snapshot, we will use that information to make QP determinations under
the All-Payer Combination Option. This payment amount and patient count
information is to be submitted in a way that allows us to distinguish
information from January 1 through March 31, January 1 through June 30,
and January 1 through August 31 so that we can make QP determinations
based on the two finalized snapshot dates (82 FR 30203 through 30204).
The CY 2018 Quality Payment Program final rule specified that APM
Entities or eligible clinicians must submit all of the required
information about the Other Payer Advanced APMs in which they
participate, including those for which there is a pending request for
an Other Payer Advanced APM determination, as well as the payment
amount and patient count information sufficient for us to make QP
determinations by December 1 of the calendar year that is 2 years to
prior to the payment year, which we refer to as the QP Determination
Submission Deadline (82 FR 53886).
In section III.I.4.e.(5)(b) of this final rule, we are finalizing
the addition of a third alternative to allow QP determinations at the
TIN level in instances where all clinicians who have reassigned billing
rights to the TIN participate in a single (the same) APM Entity. This
option will therefore be available to all TINs participating in Full
TIN APMs, such as the Medicare Shared Savings Program. It will also be
available to any other TIN for which all clinicians who have reassigned
billing rights to the TIN participating in a single APM Entity. To make
QP determinations under the All-Payer Combination Option at the TIN
level as finalized using either the payment amount or patient count
method, we will need to receive, by December 1 of the calendar year
that is 2 years to prior to the payment year, all of the payment amount
and patient count information: (1) Attributable to the eligible
clinician, TIN, or APM Entity through every Other Payer Advanced APM;
and (2) for all other payments or patients, except from excluded
payers, made or attributed to the eligible clinician(s) during the QP
performance period for the periods January 1 through March 31, January
1 through June 30, and January 1 through August 31.
As shown in Table 87, we assume that 4 APM Entities, 225 TINs, and
80 eligible clinicians will submit data for QP determinations under the
All-Payer Combination Option in 2019. We estimate it will take the APM
Entity representative, TIN representative, or eligible clinician 5
hours at $107.38/hr for a practice administrator to complete this
submission. In aggregate, we estimate an annual burden of 1,545 hours
(309 respondents x 5 hr) at a cost of $165,902 (1,545 hr x $107.38/hr).

Table 87--Estimated Burden for the Submission of Data for All-Payer QP
Determinations
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
# of APM Entities submitting data for All-Payer QP 4
Determinations (a).....................................
# of TINs submitting data for All-Payer QP 225
Determinations (b).....................................
# of eligible submitting data for All-Payer QP 80
Determinations (c).....................................
Hours Per respondent QP Determinations (d).............. 5
---------------
Total Hours (g) = [(a) * (d)] + [(b) * (d)] + [(c) * 1,545
(d)]...............................................
---------------
Labor rate for a Practice Administrator ($107.38) (h)... $107.38/hr
---------------
Total Annual Cost for Submission of Data for All- $165,902
Payer QP Determinations (i) = (g) * (h)............
------------------------------------------------------------------------

[[Page 60022]]

We received no public comments related to the burden estimates for
the Submission of Data for All-Payer QP Determinations. The burden
estimates have been updated from the CY 2019 PFS proposed rule to
reflect updated respondent estimates (83 FR 36038 through 36039).
18. Quality Payment Program ICRs Regarding Voluntary Participants
Election To Opt-Out of Performance Data Display on Physician Compare
(Sec. 414.1395)
This rule does not include any new or revised reporting,
recordkeeping, or third-party disclosure requirements related to the
election by voluntary participants to opt-out of public reporting on
Physician Compare. However, we have adjusted our currently approved
burden estimates based on more recent data. The adjusted burden will be
submitted to OMB for approval under control number 0938-1314 (CMS-
10621).
We estimate that 10 percent of the total clinicians and groups who
will voluntarily participate in MIPS will also elect not to participate
in public reporting. This results in a total of 11,617 (10 percent x
116,174 voluntary MIPS participants), a decrease of 10,783 from the
total respondents currently approved by OMB under the aforementioned
control number due to the reduction in voluntary participation in MIPS
overall. As we discussed earlier in this section of the final rule,
voluntary respondents are clinicians that are not QPs and are expected
to be excluded from MIPS after applying the eligibility requirements
discussed in section III.I.3.a. of this final rule, but have elected to
submit data to MIPS. In implementing the finalized opt-in policy, we
estimate that 33 percent of clinicians that exceed 1 of the low-volume
criteria, but not all 3, will elect to opt-in to MIPS, become MIPS
eligible, and no longer be considered a voluntary reporter. This logic
was also applied in the regulatory impact analysis of this rule. Table
88 shows that for these voluntary participants, we estimate it will
take 0.25 hours at $89.18/hr for a computer system analyst to submit a
request to opt-out. In aggregate, we estimate an annual burden of
2,904.25 hours (11,617 requests x 0.25 hr/request) at a cost of
$259,001 (2,904.25 hr x $89.18/hr).
The decrease in the number of respondents due to policies finalized
in this rule results in a decrease of -2,695.75 hours (-10,783
respondents x 0.25 hr) and -$240,407 (-2,695.75 hours x $89.18/hr).

Table 88--Estimated Burden for Voluntary Participants To Elect Opt Out
of Performance Data Display on Physician Compare
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
# of Voluntary Participants Opting Out of Physician 11,617
Compare (a)............................................
Total Annual Hours Per Opt-out Requester (b)............ 0.25
---------------
Total Annual Hours for Opt-out Requester (c) = (a) * 2,904.25
(b)................................................
---------------
Labor rate for a computer systems analyst (d)........... $89.18/hr
---------------
Total Annual Cost for Opt-out Requests (e) = (a) * $259,001
(d)................................................
------------------------------------------------------------------------

We received no public comments related to the burden estimates for
voluntary participants to elect to opt out of performance data display
on Physician Compare. However, the burden estimates have not been
updated from the CY 2019 PFS proposed rule to reflect availability of
data from the 2017 MIPS performance period (83 FR 36039).
19. Summary of Annual Quality Payment Program Burden Estimates
Table 89 summarizes this final rule's burden estimates for the
Quality Payment Program. To understand the burden implications of the
policies finalized in this rule, we have also estimated a baseline
burden of continuing the policies and information collections set forth
in the CY 2018 Quality Payment Program final rule into the 2019 MIPS
performance period. Our baseline burden estimates reflect the recent
availability of data sources to more accurately reflect the number of
the respondents for the quality, Promoting Interoperability, and
improvement activities performance categories and the number of
organizations exempt from the Promoting Interoperability performance
category.
BILLING CODE 4120-01-P

[[Page 60023]]

[GRAPHIC] [TIFF OMITTED] TR23NO18.079

BILLING CODE 4120-01-C
Table 90 provides the reasons for changes in the estimated burden
for information collections in this final rule. We have divided the
reasons for

[[Page 60024]]

our change in burden into those related to new policies and those
related to changes in the baseline burden of continued Quality Payment
Program Year 2 policies that reflect updated data and methods.

Table 90--Reasons for Change in Burden Compared to the Currently
Approved CY 2018 Information Collection Burdens
------------------------------------------------------------------------
Changes to
``baseline'' of
Changes in burden burden continued Year
Table in collection of due to finalized 2 policy (italics are
information Year 3 policies changes in number of
respondents' due to
updated data)
------------------------------------------------------------------------
Table 62: Qualified Registry None............. After a review of the
Self-Nomination. self-nomination
process, we
determined it is
more accurate to
separately assess
the burden of
Qualified Registry
and QCDR self-
nomination rather
than aggregate them
in the same ICR.
Review of self-
nomination process
resulted in a
decrease in
estimated time
needed to complete
simplified self-
nomination (-9.5 hr.
computer system
analyst time) and
full self-nomination
(-7 hr. computer
system analyst
time).
Increase in the
number of
respondents as the
number of qualified
registries enrolling
increases and the
basis for estimating
the number of
respondents is
updated to reflect
the number of self-
nomination
applications
received in place of
the number of
qualified registries
being approved.
Table 63: QCDR Self-Nomination None............. After a review of the
self-nomination
process, we
determined it is
more accurate to
separately assess
the burden of
Qualified Registry
and QCDR self-
nomination rather
than aggregate them
in the same ICR.
Review of self-
nomination process
resulted in an
increase in
estimated time
needed to complete
simplified self-
nomination (-0.5 hr.
computer system
analyst time) and
full self-nomination
(+2 hr. computer
system analyst
time).
Increase in the
number of
respondents as the
number of QCDRs
enrolling increases
and the basis for
estimating the
number of
respondents is
updated to reflect
the number of self-
nomination
applications
received in place of
the number of QCDRs
being approved.
Table 68: Quality Payment None............. Decreased number of
Program Identity Management respondents due to
Application Process. updates to the
identity management
system being used
for data submission
in the 2018 MIPS
performance period;
only new respondents
submitting quality
data using the CMS
Enterprise Portal
need to create a new
account, versus
system where all
respondents
submitting via EHR
needed to register
for user account
annually.
Table 69: Quality Performance None............. Decreased number of
Category Medicare Part B respondents due to
Claims Collection Type. updated data from
2017 MIPS
performance period.
Correction to
estimate to account
for reduced number
of required measures
compared to PQRS (6
in MIPS; 9 in PQRS)
reduced estimated
time to submit data.
Table 70: Quality Performance None............. Decreased number of
Category QCDR/MIPS CQM respondents due to
Collection Type. updated data from
2017 MIPS
performance period.
Table 71: Quality Performance None............. Decreased number of
Category eCQM Collection Type. respondents due to
updated data from
2017 MIPS
performance period.
Table 72: Quality Performance Decrease in Decrease in the
Category CMS Web Interface. number of number of
required respondents due to
measures updated data from
resulted in the 2018 MIPS
reduction in performance period
estimated time as fewer eligible
needed to submit group practices
data (-12.33 hrs elected to submit
computer system data using the CMS
analyst time). Web Interface.
Table 73: Beneficiary None............. Decrease in the
Responses to CAHPS for MIPS number of
Survey. respondents due to
updated data from
the 2018 MIPS
performance period
as fewer eligible
group practices
elect to have
vendors administer
the CAHPS for MIPS
survey and fewer
beneficiaries per
group respond to the
survey, on average.
Table 74: Registration for CMS None............. Increase in the
Web Interface. number of
respondents due to
updated data from
the 2018 MIPS
performance period
as more groups
register to submit
data using the CMS
Web Interface.
Review of
registration process
resulted in decrease
in estimated time to
register. (-0.75 hr.
computer system
analyst time).
Table 75: Registration for None............. Decrease in the
CAHPS for MIPS Survey. number of
respondents due to
updated data from
the 2018 MIPS
performance period
as fewer eligible
group practices
elect to have
vendors administer
the CAHPS for MIPS
survey.
Review of
registration process
resulted in decrease
in estimated time to
register. (-0.75 hr.
computer system
analyst time).
Table 76: Call for Quality None............. Increase in the
Measures. number of new
quality measures
being nominated.
Inclusion of time
required to complete
Peer Review Journal
Article Form
resulted in increase
in time to nominate
a quality measure.
This was a
requirement in the
CY 2017 Quality
Payment Program
final rule (81 FR
77153 through 77155)
but was not included
in burden estimates.
(+4 hrs Physician
time).
Table 77: Reweighting None............. Decrease in the
Applications for Promoting number of
Interoperability and Other respondents due to
Performance Categories. updated data from
2017 MIPS
performance period.
Review of application
process resulted in
decrease in
estimated time to
apply (-0.25 hr
computer system
analyst time).
Table 79: Promoting Decrease in Decrease in the
Interoperability Performance number of number of
Category Data Submission. required respondents due to
measures updated data from
resulted in 2017 MIPS
reduction in performance period.
estimated time
needed to submit
data (-.33 hr
computer system
analyst time).
Table 80: Call for Promoting None............. Increase in the
Interoperability Measures. number of new
Promoting
Interoperability
measures being
nominated.
Table 82: Improvement None............. Decrease in the
Activities Submission. number of
respondents due to
updated data from
2017 MIPS
performance period.

[[Page 60025]]

Review of submission
process resulted in
decrease in
estimated to submit
(-0.92 hr computer
system analyst
time).
Table 83: Nomination of None............. Review of nomination
Improvement Activities. process resulted in
increase in
estimated time to
nominate a new
improvement activity
(+0.9 hrs Practice
Administrator time;
+0.6 hrs Physician
time).
Table 84: Partial QP Election. None............. Increase in the
number of
respondents due to
additional APM
Entities and
eligible clinicians
electing to
participate as a
Partial QP in MIPS.
Table 85: Other Payer Advanced None............. Decrease in the
APM Identification: Other number of
Payer Initiated Process. anticipated other
payer arrangements
submitted for
identification as
Other Payer Advanced
APMs.
Table 86: Other Payer Advanced None............. Increase in the
APM Identification: Eligible number of
Clinician Initiated Process. anticipated other
payer arrangements
submitted by APM
Entities and
eligible clinicians
for identification
as Other Payer
Advanced APMs.
Table 87: Submission of Data Reflects new None.
for All-Payer QP policy in this
Determinations under the All- final rule..
Payer Combination Option.
Table 88: Voluntary Decrease in the None.
Participants to Elect to Opt number of
Out of Performance Data respondents due
Display on Physician Compare. to updated data
from 2017 MIPS
performance
period.
------------------------------------------------------------------------

C. Summary of Annual Burden Estimates for Finalized Requirements

Table 91--Annual Requirements and Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total annual
Regulation section(s) under Title OMB control Respondents Responses Burden per response burden Labor cost of Total cost ($)
42 of the CFR No. *** (hours) (hours) reporting ($/hr) *
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 414.94(j) (AUC 0938-1345 10,230,000 3,410,000 0.033................ 112,530 Varies............... 5,527,924
consultations) Voluntary period. (2 min)..............
Sec. 414.94(j) (AUC 0938-1345 586,386 43,181,818 0.033................ 1,425,000 Varies............... 70,001,700
consultations) Beginning Jan 1, (2 min)..............
2020.
Sec. 414.94 (AUC recordkeeping) 0938-1345 586,386 6,699 0.167................ 1,119 34.50................ 38,596
(10 min).............
Quality Payment Program (See 0938-1314 (**) (517,537) varies............... (2,450,334) varies............... (221,510,118)
Subtotal Under Table 89).
Quality Payment Program (See 0938-1222 (93,447) (93,447) varies............... (21,195) varies............... (546,362)
Subtotal Under Table 89).
----------------------------------------------------------------------------------------------------------------------
Total........................ ............ 10,722,939 45,987,533 Varies............... (932,880) Varies............... (146,488,260)
--------------------------------------------------------------------------------------------------------------------------------------------------------
* For the PRA, this rule will not impose any non-labor costs.
** We are unable to accurately calculate a total number of respondents for the Quality Payment Program. In many cases, individuals, groups, and entities
have responded to multiple data collections and there is no unified way to identify unique respondents.
*** OMB and CMS' PRA package ID numbers: OMB 0938-1345 (CMS-10654), OMB 0938-1314 (CMS-10621), and OMB 0938-1222 (CMS-10450).
**** For OMB 0938-1314 (CMS-10621), the estimated total number of respondents across all ICRs for the CY 2019 performance period is 644,144 while
estimated total burden hours are 5,109,042 at a cost of $482,416,597. (CMS-10450), the estimated total number of respondents across all ICRs for the
CY 2019 performance period is 39,336 while estimated total burden hours are 8,755 at a cost of $236,525. For OMB 0938-1343 (CMS-10652), the estimated
total number of respondents across all ICRs for the CY 2019 performance period is 16 while estimated total burden hours are 160 at a cost of $13,506.

VII. Regulatory Impact Analysis

A. Statement of Need

This final rule makes payment and policy changes under the Medicare
PFS and implements required statutory changes under the Medicare Access
and CHIP Reauthorization Act of 2015 (MACRA), the Achieving a Better
Life Experience Act (ABLE), the Protecting Access to Medicare Act of
2014 (PAMA), section 603 of the Bipartisan Budget Act of 2015, the
Consolidated Appropriations Act of 2016, the Bipartisan Budget Act of
2018, and section 2001(a) of the SUPPORT for Patients and Communities
Act of 2018. This final rule also makes changes to payment policy and
other related policies for Medicare Part B.
This final rule is necessary to make policy changes under Medicare
fee-for-service. Therefore, we included a detailed regulatory impact
analysis (RIA) to assess all costs and benefits of available regulatory
alternatives and explained the selection of these regulatory approaches
that we believe adhere to section 1834(q) of the Act and, to the extent
feasible, maximize net benefits.
This final rule also makes payment and policy changes under the
Medicare PFS and makes required statutory changes under the MACRA, as
amended by section 51003 of the Bipartisan Budget Act of 2018.
The new policies for CY 2019 are detailed throughout this final
rule. For example, the policies associated with modernizing Medicare
physician payment by recognizing communication technology-based
services are described in section II.D. of this final rule, while the
policies associated with E/M visits are described in section II.I. of
this final rule. Several policies addressing the use of innovative
technology that enables remote services will expand access to care and
create more opportunities for patients to access more personalized care
management, as well as connect with their physicians more quickly.
These policies support access to care using telecommunications
technology by paying clinicians for virtual check-ins (brief, non-face-
to-face appointments via communications technology), paying clinicians
for evaluation of patient-submitted photos or videos, and

[[Page 60026]]

expanding Medicare-covered telehealth services to include prolonged
preventive services.
Several policies in the final rule will also give physicians more
time to spend with their patients, especially those with complex needs,
rather than on paperwork. Specifically, there are provisions that
simplify certain documentation requirements for E/M visits, which make
up about 40 percent of allowed charges under the PFS and consume much
of clinicians' time; reduce supervision requirements for radiologist
assistants during diagnostic test services; and remove burdensome and
overly complex functional reporting requirements for outpatient
therapy. In addition, section VII.H. of this final rule, the RIA,
details the economic effect of these policies on Medicare providers and
beneficiaries.

B. Overall Impact

We examined the impact of this rule as required by Executive Order
12866 on Regulatory Planning and Review (September 30, 1993), Executive
Order 13563 on Improving Regulation and Regulatory Review (February 2,
2013), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub.
L. 96-354), section 1102(b) of the Social Security Act, section 202 of
the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-
4), Executive Order 13132 on Federalism (August 4, 1999), the
Congressional Review Act (5 U.S.C. 804(2)), and Executive Order 13771
on Reducing Regulation and Controlling Regulatory Costs (January 30,
2017).
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). An RIA
must be prepared for major rules with economically significant effects
($100 million or more in any 1 year). We estimated, as discussed in
this section, that the PFS policies included in this final rule would
redistribute more than $100 million in 1 year. Therefore, we estimate
that this rulemaking is ``economically significant'' as measured by the
$100 million threshold, and hence also a major rule under the
Congressional Review Act. Accordingly, we prepared an RIA that, to the
best of our ability, presents the costs and benefits of the rulemaking.
The RFA requires agencies to analyze options for regulatory relief of
small entities. For purposes of the RFA, small entities include small
businesses, nonprofit organizations, and small governmental
jurisdictions. Most hospitals, practitioners and most other providers
and suppliers are small entities, either by nonprofit status or by
having annual revenues that qualify for small business status under the
Small Business Administration standards. (For details see the SBA's
website at https://www.sba.gov/content/table-small-business-size-standards (refer to the 620000 series)). Individuals and states are not
included in the definition of a small entity.
The RFA requires that we analyze regulatory options for small
businesses and other entities. We prepare a regulatory flexibility
analysis unless we certify that a rule would not have a significant
economic impact on a substantial number of small entities. The analysis
must include a justification concerning the reason action is being
taken, the kinds and number of small entities the rule affects, and an
explanation of any meaningful options that achieve the objectives with
less significant adverse economic impact on the small entities.
Approximately 95 percent of practitioners, other providers, and
suppliers are considered to be small entities, based upon the SBA
standards. There are over 1 million physicians, other practitioners,
and medical suppliers that receive Medicare payment under the PFS.
Because many of the affected entities are small entities, the analysis
and discussion provided in this section, as well as elsewhere in this
final rule is intended to comply with the RFA requirements regarding
significant impact on a substantial number of small entities.
For example, the effects of changes to payment rates for
practitioners, other providers, and suppliers are discussed in VII.C.
of this final rule. Alternative options considered to the payment rates
are discussed generally in section VII.F. of this final rule.
In addition, section 1102(b) of the Act requires us to prepare an
RIA if a rule may have a significant impact on the operations of a
substantial number of small rural hospitals. This analysis must conform
to the provisions of section 604 of the RFA. For purposes of section
1102(b) of the Act, we define a small rural hospital as a hospital that
is located outside of a Metropolitan Statistical Area for Medicare
payment regulations and has fewer than 100 beds. The PFS does not
reimburse for services provided by rural hospitals; the PFS pays for
physicians' services, which can be furnished by physicians and non-
physician practitioners in a variety of settings, including rural
hospitals. We did not prepare an analysis for section 1102(b) of the
Act because we determined, and the Secretary certified, that this final
rule would not have a significant impact on the operations of a
substantial number of small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 also
requires that agencies assess anticipated costs and benefits on state,
local, or tribal governments or on the private sector before issuing
any rule whose mandates require spending in any 1 year of $100 million
in 1995 dollars, updated annually for inflation. In 2018, that
threshold is approximately $150 million. This final rule will impose no
mandates on state, local, or tribal governments or on the private
sector.
Executive Order 13132 establishes certain requirements that an
agency must meet when it issues a proposed rule (and subsequent final
rule) that imposes substantial direct requirement costs on state and
local governments, preempts state law, or otherwise has Federalism
implications. Since this regulation does not impose any costs on state
or local governments, the requirements of Executive Order 13132 are not
applicable.
Executive Order 13771, entitled Reducing Regulation and Controlling
Regulatory Costs (82 FR 9339), was issued on January 30, 2017. This
final rule is considered an E.O. 13771 deregulatory action because it
is expected to result in regulatory cost savings. The estimated impact
would be $71 million in cost savings in 2019, $3.986 billion in costs
in 2020, $387 million in cost savings in 2021, $450 million cost
savings in 2022, and $557 million in cost savings in 2023 and
thereafter. Annualizing these costs and cost savings in perpetuity and
discounting at 7 percent back to 2016, we estimated that this rule
would generate $190 million in annualized net cost savings for E.O.
13771 accounting purposes. Details on the estimated cost savings of
this rule can be found in the following analyses.
We prepared the following analysis, which together with the
information provided in the rest of this preamble, meets all assessment
requirements. The analysis explains the rationale for and purposes of
this final rule; details the costs and benefits of the rule; analyzes
alternatives; and presents the measures we would use to minimize the
burden on small entities. As indicated elsewhere in this final rule, we
are implementing a variety of changes to our regulations, payments, or
payment policies to ensure that our payment

[[Page 60027]]

systems reflect changes in medical practice and the relative value of
services, and implementing statutory provisions. We provided
information for each of the policy changes in the relevant sections of
this final rule. We are unaware of any relevant federal rules that
duplicate, overlap, or conflict with this final rule. The relevant
sections of this final rule contain a description of significant
alternatives if applicable.

C. Changes in Relative Value Unit (RVU) Impacts

1. Resource-Based Work, PE, and MP RVUs
Section 1848(c)(2)(B)(ii)(II) of the Act requires that increases or
decreases in RVUs may not cause the amount of expenditures for the year
to differ by more than $20 million from what expenditures would have
been in the absence of these changes. If this threshold is exceeded, we
make adjustments to preserve budget neutrality.
Our estimates of changes in Medicare expenditures for PFS services
compared payment rates for CY 2018 with payment rates for CY 2019 using
CY 2017 Medicare utilization. The payment impacts in this final rule
reflect averages by specialty based on Medicare utilization. The
payment impact for an individual practitioner could vary from the
average and would depend on the mix of services he or she furnishes.
The average percentage change in total revenues will be less than the
impact displayed here because practitioners and other entities
generally furnish services to both Medicare and non-Medicare patients.
In addition, practitioners and other entities may receive substantial
Medicare revenues for services under other Medicare payment systems.
For instance, independent laboratories receive approximately 83 percent
of their Medicare revenues from clinical laboratory services that are
paid under the Clinical Laboratory Fee Schedule (CLFS).
The annual update to the PFS conversion factor (CF) was previously
calculated based on a statutory formula; for details about this
formula, we refer readers to the CY 2015 PFS final rule with comment
period (79 FR 67741 through 67742). Section 101(a) of the MACRA
repealed the previous statutory update formula and amended section
1848(d) of the Act to specify the update adjustment factors for CY 2015
and beyond. The update adjustment factor for CY 2019, as required by
section 53106 of the Bipartisan Budget Act of 2018, is 0.25 percent
before applying other adjustments.
To calculate the CF for this year, we multiplied the product of the
current year CF and the update adjustment factor by the budget
neutrality adjustment described in the preceding paragraphs. We
estimated the CY 2019 PFS CF to be 36.0391 which reflects the budget
neutrality adjustment under section 1848(c)(2)(B)(ii)(II) and the 0.25
percent update adjustment factor specified under section 1848(d)(18) of
the Act. We estimate the CY 2019 anesthesia CF to be 22.2730, which
reflects the same overall PFS adjustments with the addition of
anesthesia-specific PE and MP adjustments.

Table 92--Calculation of the Final CY 2019 PFS Conversion Factor
------------------------------------------------------------------------

------------------------------------------------------------------------
CY 2018 Conversion Factor......... .................... 35.9996
Statutory Update Factor....... 0.25 percent ..............
(1.0025).
CY 2019 RVU Budget Neutrality -0.14 percent ..............
Adjustment. (0.9986).
CY 2019 Conversion Factor......... .................... 36.0391
------------------------------------------------------------------------

Table 93--Calculation of the Final CY 2019 Anesthesia Conversion Factor
------------------------------------------------------------------------

------------------------------------------------------------------------
CY 2018 National Average .................... 22.1887
Anesthesia Conversion Factor.
Statutory Update Factor....... 0.25 percent ..............
(1.0025).
CY 2019 RVU Budget Neutrality -0.14 percent ..............
Adjustment. (0.9986).
CY 2019 Anesthesia Fee 0.27 percent ..............
Schedule Practice Expense and (1.0027).
Malpractice Adjustment.
CY 2019 Conversion Factor......... .................... 22.2730
------------------------------------------------------------------------

Table 94 shows the payment impact on PFS services of the policies
contained in this final rule. To the extent that there are year-to-year
changes in the volume and mix of services provided by practitioners,
the actual impact on total Medicare revenues would be different from
those shown in Table 94 (CY 2019 PFS Estimated Impact on Total Allowed
Charges by Specialty). The following is an explanation of the
information represented in Table 94.
Column A (Specialty): Identifies the specialty for which
data are shown.
Column B (Allowed Charges): The aggregate estimated PFS
allowed charges for the specialty based on CY 2017 utilization and CY
2018 rates. That is, allowed charges are the PFS amounts for covered
services and include coinsurance and deductibles (which are the
financial responsibility of the beneficiary). These amounts have been
summed across all services furnished by physicians, practitioners, and
suppliers within a specialty to arrive at the total allowed charges for
the specialty.
Column C (Impact of Work RVU Changes): This column shows
the estimated CY 2019 impact on total allowed charges of the changes in
the work RVUs, including the impact of changes due to potentially
misvalued codes.
Column D (Impact of PE RVU Changes): This column shows the
estimated CY 2019 impact on total allowed charges of the changes in the
PE RVUs.
Column E (Impact of MP RVU Changes): This column shows the
estimated CY 2019 impact on total allowed charges of the changes in the
MP RVUs.
Column F (Combined Impact): This column shows the
estimated CY 2019 combined impact on total allowed charges of all the
changes in the previous columns. Column F may not equal the sum of
columns C, D, and E due to rounding.

[[Page 60028]]

Table 94--CY 2019 PFS Estimated Impact on Total Allowed Charges by Specialty
----------------------------------------------------------------------------------------------------------------
Impact of work Impact of PE Impact of MP
Specialty Allowed RVU changes RVU changes RVU changes Combined
charges (mil) (%) (%) (%) impact (%)
(A) (B) (C) (D) (E) (F)
----------------------------------------------------------------------------------------------------------------
Allergy/Immunology.............. $239 0 -1 0 -1
Anesthesiology.................. 1,982 0 0 0 0
Audiologist..................... 68 0 1 0 1
Cardiac Surgery................. 293 0 0 0 0
Cardiology...................... 6,616 0 0 0 0
Chiropractor.................... 754 0 -1 0 -1
Clinical Psychologist........... 776 0 3 0 3
Clinical Social Worker.......... 728 0 3 0 2
Colon and Rectal Surgery........ 166 0 1 0 1
Critical Care................... 342 0 -1 0 -1
Dermatology..................... 3,489 0 1 0 1
Diagnostic Testing Facility..... 734 0 -5 0 -5
Emergency Medicine.............. 3,121 0 0 0 0
Endocrinology................... 482 0 0 0 0
Family Practice................. 6,207 0 0 0 0
Gastroenterology................ 1,754 0 0 0 0
General Practice................ 428 0 0 0 0
General Surgery................. 2,090 0 0 0 0
Geriatrics...................... 197 0 0 0 0
Hand Surgery.................... 214 0 0 0 0
Hematology/Oncology............. 1,741 0 -1 0 -1
Independent Laboratory.......... 646 0 -2 0 -2
Infectious Disease.............. 649 0 0 0 -1
Internal Medicine............... 10,766 0 0 0 0
Interventional Pain Mgmt........ 868 0 1 0 1
Interventional Radiology........ 384 1 1 0 2
Multispecialty Clinic/Other Phys 149 0 0 0 0
Nephrology...................... 2,188 0 0 0 0
Neurology....................... 1,529 0 0 0 0
Neurosurgery.................... 802 0 0 0 0
Nuclear Medicine................ 50 0 -1 0 -1
Nurse Anes/Anes Asst............ 1,242 0 0 0 0
Nurse Practitioner.............. 4,060 0 0 0 0
Obstetrics/Gynecology........... 637 0 0 0 0
Ophthalmology................... 5,451 0 -1 0 -1
Optometry....................... 1,309 0 -1 0 -1
Oral/Maxillofacial Surgery...... 67 0 0 0 0
Orthopedic Surgery.............. 3,741 0 0 0 0
Other........................... 31 0 4 0 4
Otolarngology................... 1,222 0 0 0 0
Pathology....................... 1,165 0 -1 0 -2
Pediatrics...................... 61 0 0 0 0
Physical Medicine............... 1,107 0 0 0 0
Physical/Occupational Therapy... 3,950 0 -1 0 -1
Physician Assistant............. 2,438 0 0 0 0
Plastic Surgery................. 376 0 0 0 0
Podiatry........................ 1,974 0 2 0 2
Portable X-Ray Supplier......... 99 0 1 0 1
Psychiatry...................... 1,187 0 1 0 1
Pulmonary Disease............... 1,714 0 0 0 0
Radiation Oncology and Radiation 1,765 0 0 0 -1
Therapy Centers................
Radiology....................... 4,907 0 0 0 0
Rheumatology.................... 541 0 0 0 0
Thoracic Surgery................ 357 0 0 0 0
Urology......................... 1,738 0 1 0 1
Vascular Surgery................ 1,141 0 2 0 2
-------------------------------------------------------------------------------
Total....................... 92,733 0 0 0 0
----------------------------------------------------------------------------------------------------------------
* Column F may not equal the sum of columns C, D, and E due to rounding.

2. CY 2019 PFS Impact Discussion
a. Changes in RVUs
The most widespread specialty impacts of the RVU changes are
generally related to the changes to RVUs for specific services
resulting from the misvalued code initiative, including RVUs for new
and revised codes. The estimated impacts for some specialties,
including clinical psychologists, vascular surgery, interventional
radiology, and podiatry, reflect increases relative to other physician
specialties. These increases can largely be attributed to finalized
increases in

[[Page 60029]]

value for particular services following the recommendations from the
American Medical Association (AMA)'s Relative Value Scale Update
Committee (RUC) and CMS review, increased payments as a result of
finalized updates to supply and equipment pricing, and the
implementation of new payment policies associated with communication
technology-based services.
The estimated impacts for several specialties, including diagnostic
testing facilities, independent labs, pathology, and ophthalmology,
reflect decreases in payments relative to payment to other physician
specialties. These decreases can largely be attributed to revaluation
of individual procedures reviewed by the AMA's committee and CMS,
decreased payments as a result of finalized updates to supply and
equipment pricing, and continued implementation of previously finalized
code-level reductions that are being phased-in over several years. We
note that the estimated impacts for many specialties differ
significantly relative to the estimates included in the proposed rule.
These changes reflect changes between the proposed and final policies
based on our consideration of public comments. We note that the most
significant of these changes relates to the various elements of the
proposed changes in coding and payment for office/outpatient E/M
visits, none of which are being finalized for CY 2019. For independent
laboratories, it is important to note that these entities receive
approximately 83 percent of their Medicare revenues from services that
are paid under the CLFS. As a result, the estimated 2 percent reduction
for CY 2019 is only applicable to approximately 17 percent of the
Medicare payment to these entities.
We often receive comments regarding the changes in RVUs displayed
on the specialty impact table (Table 94), including comments received
in response to the proposed rates. We remind stakeholders that although
the estimated impacts are displayed at the specialty level, typically
the changes are driven by the valuation of a relatively small number of
new and/or potentially misvalued codes. The percentages in Table 94 are
based upon aggregate estimated PFS allowed charges summed across all
services furnished by physicians, practitioners, and suppliers within a
specialty to arrive at the total allowed charges for the specialty, and
compared to the same summed total from the previous calendar year.
Therefore, they are averages, and may not necessarily be representative
of what is happening to the particular services furnished by a single
practitioner within any given specialty.
b. Impact
Column F of Table 94 displays the estimated CY 2019 impact on total
allowed charges, by specialty, of all the RVU changes. A table showing
the estimated impact of all of the changes on total payments for
selected high volume procedures is available under ``downloads'' on the
CY 2019 PFS final rule website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/. We selected these
procedures for sake of illustration from among the procedures most
commonly furnished by a broad spectrum of specialties. The change in
both facility rates and the nonfacility rates are shown. For an
explanation of facility and nonfacility PE, we refer readers to
Addendum A on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/.
c. Estimated Impacts of Implementing the Payment and Coding Changes for
Office/Outpatient E/M Services for CY 2021
Although we are not finalizing changes to E/M coding and payment
for CY 2019, we are finalizing certain changes for CY 2021. We provide
the following impact estimate only for illustrative purposes. Table 95
illustrates the estimated specialty level impacts associated with
implementing our finalized policies for E/M coding and payment in CY
2019, rather than delaying until CY 2021. Table 24C shows the estimated
impacts of adopting single payment rates for new and established
patient E/M visit levels 2-4 (with the rates determined using input
values that reflect the weighted average of 2018 inputs for codes
describing those visit levels), keeping separate rates for new and
established patient E/M visit level 5 (with the rates determined using
the 2018 input values for level 5 visits), and adopting add-on codes
with equal rates to adjust for the inherent visit complexity of primary
care and non-procedural specialty care (with the rates determined using
the input values from the proposed rule for the non-procedural
specialty care complexity code).

TABLE 95--Estimated Specialty Level Impacts of Final E/M Payment and Coding Policies If Implemented for 2019
----------------------------------------------------------------------------------------------------------------
Allowed Impact of work Impact of PE Impact of MP Combined
Specialty charges (mil) RVU changes % RVU changes % RVU changes % impact %
(A) (B) (C) (D) (E) (F)
----------------------------------------------------------------------------------------------------------------
Allergy/Immunology.............. $239 0 0 0 0
Anesthesiology.................. 1,981 -1 0 0 -2
Audiologist..................... 68 -1 1 0 0
Cardiac Surgery................. 294 -1 -1 0 -2
Cardiology...................... 6,618 -1 -1 0 -2
Chiropractor.................... 754 -1 0 0 -1
Clinical Psychologist........... 776 -1 1 0 0
Clinical Social Worker.......... 728 -2 2 0 0
Colon and Rectal Surgery........ 166 0 1 0 0
Critical Care................... 342 -2 -1 0 -3
Dermatology..................... 3,486 1 3 0 4
Diagnostic Testing Facility..... 733 0 -5 0 -5
Emergency Medicine.............. $3,121 -2 -1 0 -2
Endocrinology................... 482 -1 -1 0 -2
Family Practice................. 6,208 1 1 0 2
Gastroenterology................ 1,757 -2 -1 0 -3
General Practice................ 429 2 1 0 3
General Surgery................. 2,093 0 0 0 -1

[[Page 60030]]

Geriatrics...................... 197 -1 -1 0 -1
Hand Surgery.................... 214 1 1 0 3
Hematology/Oncology............. 1,741 0 -1 0 0
Independent Laboratory.......... 646 -1 3 0 3
Infectious Disease.............. 649 -1 -1 0 -1
Internal Medicine............... 10,767 0 0 0 0
Interventional Pain Mgmt........ 868 1 2 0 3
Interventional Radiology........ 386 0 -2 0 -2
Multispecialty Clinic/Other Phys 149 -1 -1 0 -2
Nephrology...................... 2,190 -1 -1 0 -2
Neurology....................... 1,529 -1 0 0 -1
Neurosurgery.................... 804 -1 -1 0 -1
Nuclear Medicine................ 50 -1 -1 0 -3
Nurse Anes/Anes Asst............ 1,242 -2 0 0 -2
Nurse Practitioner.............. 4,065 2 1 0 3
Obstetrics/Gynecology........... 638 2 2 0 5
Ophthalmology................... 5,448 -1 -2 0 -3
Optometry....................... $1,309 0 -1 0 -1
Oral/Maxillofacial Surgery...... 68 0 0 0 1
Orthopedic Surgery.............. 3,743 0 1 0 1
Other........................... 31 -1 3 0 2
Otolarngology................... 1,210 3 3 0 5
Pathology....................... 1,165 -1 -1 0 -2
Pediatrics...................... 61 1 0 0 1
Physical Medicine............... 1,107 -1 0 0 -2
Physical/Occupational Therapy... 3,950 -1 -2 0 -3
Physician Assistant............. 2,457 2 1 0 4
Plastic Surgery................. 377 0 0 0 1
Podiatry........................ 1,974 4 6 0 10
Portable X-Ray Supplier......... 99 0 0 0 0
Psychiatry...................... 1,187 3 2 0 5
Pulmonary Disease............... 1,715 -1 -1 0 -2
Radiation Oncology and Radiation 1,766 -1 -1 0 -1
Therapy Centers................
Radiology....................... 4,911 -1 -1 0 -2
Rheumatology.................... 541 0 -1 0 -1
Thoracic Surgery................ 358 -1 -1 0 -2
Urology......................... 1,738 2 3 0 4
Vascular Surgery................ 1,148 0 -2 0 -2
-------------------------------------------------------------------------------
Total....................... 92,771 0 0 0 0
----------------------------------------------------------------------------------------------------------------

Under our finalized policies, specialties that disproportionately
report lower level visits, such as podiatry, and specialties that
report office/outpatient visits in conjunction with minor procedures,
such as dermatology, would see significant increases. Specialties that
predominantly furnish higher level visits would have their negative
redistribution significantly mitigated by the maintenance of the level
5 visit and the add-on codes for inherent visit complexity for primary
and non-procedural specialty care.
We note that our original proposal was developed more generally to
maintain overall RVUs within the codes describing office/outpatient
visits, but, after consideration of public comments, we are not
finalizing several elements of those proposals, including and
especially the multiple procedure payment reduction. As a result,
implementation with the values and policies as altered, would require
off-setting reductions in overall PFS payments. Following our current
methodology, these reductions, required by statute, would be applied
through a budget neutrality adjustment in the PFS CF, consistent with
our established methodology. As a result of such an adjustment,
specialties that do not furnish office/outpatient visits generally
would see overall reductions in payment of approximately 2.0 percent,
as generally reflected in the Table 95. Given that overall payment for
the office/outpatient E/M codes would increase, and because these
services are reported by most specialities, the overall changes for
most specialties are generally offsetting. However, for physician
specialties and suppliers that do not report office/outpatient E/M
services, the reduction would be approximately -2.0 percent.
As discussed in section II.H., of this final rule, based on the
statements by commenters that the medical community, through the CPT
process, has committed itself to considering revisions to the office/
outpatient visit codes and given the history of collaboration between
CMS and the medical community, we expect to consider any possible
changes in CPT coding, as well as recommendations regarding valuation
for services, from the RUC and other stakeholders, through our annual
rulemaking process, between now and implementation for

[[Page 60031]]

CY 2021. We note that any potential coding changes, and recommendations
in overall valuation for new or existing codes, could have significant
impact on the actual change in overall RVUs for office/outpatient
visits relative to the rest of the PFS. Given the various factors that
will be considered by the variety of stakeholders involved in the CPT
and RUC processes, we do not believe we can estimate with any degree of
certainty what the impact of potential changes might be. We also, note,
however, that any changes in coding and payment for these services
would be subject to notice and comment rulemaking.
With regard to the documentation policies we are finalizing for CY
2021, our intent is to allow clinicians a choice in how levels 2
through 5 visits are documented--using current framework, MDM or time.
Assuming the current code set for E/M office/outpatient visits is
maintained for CY 2021, when a level 2 through 4 visit (which comprises
the majority of visits currently furnished) is documented using the
current framework or MDM, documentation will be simplified by applying
a minimum level 2 documentation standard to level 2 through 4 visits.
When a level 2 through 4 visit is documented using time, practitioners
should report the appropriate code based on the time defined as typical
under the CPT code descriptors for office/outpatient E/M visits.
Practitioners will be required to document that the visit was medically
necessary and the billing practitioner spent at least the amount of
time included in the CPT as typical face-to-face with the patient. The
extended visit code can be reported with a level 2 through 4 visit when
the time of the overall visit is between 34 and 69 minutes (for
established patients) and between 38 and 89 minutes (for new patients)
of face-to-face time with the billing practitioner. (See section II.I.
of this final rule. For example, a level 2 through 4 extended visit
will require the billing practitioner to spend and document that he or
she spent at least 35 minutes face-to-face with the patient. We are
also finalizing a policy to require minimal documentation to support
reporting of the add-on codes that we are finalizing for use with the
level 2 through 4 visit codes. These add-on codes are to reflect the
inherent complexity in E/M services for primary care, and for other
non-procedural specialty care, and for extended visits).
For level 5 E/M visits, again assuming the current code set remains
in place for CY 2021, we will allow the visit to be documented using
the current framework, MDM or time. When documenting using MDM, the
current definition of level 5 MDM will apply. When documenting a level
5 visit using time, we will require the billing practitioner to
document that they spent at least the typical time for the reported
level 5 CPT code, face-to-face with the patient (currently 40 minutes
for an established patient and 60 minutes for a new patient). The add-
on codes that we are finalizing for use with the level 2 through 4
visits (the inherent complexity add-on codes for primary care and other
non-procedural specialty care and extended visits) will not be
reportable with level 5 visits. We note that the current coding for
prolonged visits would continue to be reportable with level 5 visits.
As discussed elsewhere in this section of the final rule, we
estimate this approach would lead to significant burden reduction for
practitioners, while allowing preparatory time and time for potential
refinement over the next few years as we take into account any feedback
from stakeholders on these changes, as well as any potential revisions
to the E/M code set.

D. Effect of Changes Related to Telehealth

As discussed in section II.D. of this final rule, we are adding two
new codes, HCPCS codes G0513 and G0514, to the list of Medicare
telehealth services. Although we expect these changes to have the
potential to increase access to care in rural areas, based on recent
telehealth utilization of services already on the list, including
services similar to the proposed additions, we estimate there will only
be a negligible impact on PFS expenditures from these additions. For
example, for services already on the list, they are furnished via
telehealth, on average, less than 0.1 percent of the time they are
reported overall. This addition was responsive to longstanding
stakeholder interest in expanding Medicare payment for telehealth
services. The restrictions placed on Medicare telehealth by the statute
limit the magnitude of utilization; however, we believe there is value
in allowing physicians and patients the greatest flexibility when
appropriate.

E. Effect of Changes to Payment to Provider-Based Departments (PBDs) of
Hospitals Paid Under the PFS

As discussed in section II.G. of this final rule, we are finalizing
a PFS Relativity Adjuster of 40 percent for CY 2019, meaning that
nonexcepted items and services furnished by nonexcepted off-campus PBDs
will be paid under the PFS at a rate that is 40 percent of the OPPS
rate. In finalizing our policy to maintain the PFS Relativity Adjuster
at 40 percent, we updated our analysis to include a full year of claims
data. We estimated site-specific PFS rates for the technical component
of a service for the entire range of HCPCS codes furnished in
nonexcepted off campus PBDs. Next we compared the sum of the site-
specific payment rates under the PFS, weighted by OPPS claims volume,
to the sum of payment rates under the OPPS, also weighted by OPPS
claims volume. This calculation resulted in a relative rate of
approximately 40 percent, supporting our policy to maintain the PFS
Relativity Adjuster at 40 percent. We are finalizing the PFS Relativity
Adjuster of 40 percent, as proposed. There will be no additional
savings for CY 2019 relative to CY 2018 because we are maintaining the
current PFS Relativity Adjuster of 40 percent, which was finalized for
CY 2018.

F. Other Provisions of the Final Regulation

1. Part B Drugs: Application of an Add-On Percentage for Certain
Wholesale Acquisition Cost (WAC)-Based Payments
In section II.M. of this final rule, we finalized the following
policy: Effective January 1, 2019, Wholesale Acquisition Cost (WAC)-
based payments for Part B drugs made under section 1847A(c)(4) of the
Act will utilize a 3 percent add-on in place of the 6 percent add-on
that is currently being used. We also will permit Medicare
Administrative Contractors (MACs) to use an add-on percentage of up to
3 percent for WAC-based payments for new drugs.
We anticipate that the reduction to the add-on payment made for a
subset of Part B drugs will result in savings to the Medicare program.
The 3 percent add-on is consistent with MedPAC's analysis and
recommendations, as well as discounts observed by MedPAC in their June
2017 Report to the Congress. We have also considered how CMS'
experience with WAC-based pricing for recently marketed new drugs and
biologicals compares to MedPAC's findings. Although the number of new
drugs that are priced using WAC is very limited, the average difference
between WAC and Average Sales Price (ASP)-based payment limits for a
group of 3 recently approved drugs and biologicals that appeared on the
ASP Drug Pricing Files (including one biosimilar biological product)
was 9.0 percent. Excluding the biosimilar biological product results in
a difference of 3.5 percent. The difference was determined by comparing
a partial quarter WAC-based payment amount determined

[[Page 60032]]

under section 1847A(c)(4) of the Act to the next quarter's ASP-based
payment amount. These findings are in general agreement with MedPAC's
findings.
Although we are able to provide examples of the relative
differences between ASP and WAC based payment limits, and we anticipate
some savings from the change in policy, we cannot estimate the
magnitude of savings over time because we cannot determine how many new
drugs and biologicals subject to partial quarter pricing will appear on
the ASP Drug Pricing files in the future or how many Part B claims for
these products will be paid. This limitation also applies to
contractor-priced drugs and biologicals that have HCPCS codes and are
in their first quarter of sales. Finally, the claims volume for
contractor-priced drugs and biologicals that are billed using
miscellaneous or Not Otherwise Classified codes, such as J3490 and
J3590, cannot be quantified. We would like to note that for the three
drugs discussed in the preceding paragraph, Medicare Part B payments
for individual doses of each drug range from approximately $3,000 to
$10,000. The payment changes finalized in this rule would result in a
little less than $100 to $300 savings in Medicare allowed charges for
each dose.
Although we cannot estimate the overall savings to the Medicare
Program or to beneficiaries, we would like to note that this change in
policy is likely to decrease copayments for individual beneficiaries
who are prescribed new drugs. Given that launch prices for single doses
for some new drugs may range from tens to hundreds of thousands of
dollars, a 3 percentage point reduction in the total payment allowance
will reduce a patient's 20 percent Medicare Part B copayment. This
reduction can result in savings to an individual beneficiary and can
help Medicare beneficiaries particularly those without supplementary
insurance, afford to pay for new drugs by reducing out of pocket
expenses.
The 3 percent add-on is expected to reduce the difference between
acquisition cost and certain WAC-based Part B drug payments. Based on
MedPAC's June 2017 Report to Congress, and for reasons discussed in
section II.M. of this rule, we do not anticipate that this change will
result in payments amounts that are below acquisition cost or that the
new policy will impair providers or patients' access to Part B drugs.
2. Changes to the Regulations Associated With the Ambulance Fee
Schedule
As discussed in section III B.2. of this final rule, section
50203(a) of the Bipartisan Budget Act of 2018 amended section
1834(l)(12)(A) and (l)(13)(A) of the Act to extend the payment add-ons
set forth in those subsections through December 31, 2022. The ambulance
extender provisions are enacted through legislation that is self-
implementing. A plain reading of the statute requires only a
ministerial application of the mandated rate increase and does not
require any substantive exercise of discretion on the part of the
Secretary. As a result, there were no policy proposals associated with
these legislative provisions or associated impact in this rule. We are
finalizing our proposal without modification to revise the dates in
Sec. 414.610(c)(1)(ii) and (c)(5)(ii) to conform the regulations to
these self-implementing statutory requirements.
In addition, as discussed in section III.B.3. of this final rule,
section 53108 of the BBA amended section 1834(l)(15) of the Act to
increase the payment reduction from 10 percent to 23 percent effective
for ambulance services furnished on or after October 1, 2018 consisting
of non-emergency basic life support services involving transports of an
individual with end stage renal disease for renal dialysis services
furnished other than on an emergency basis by a provider of services or
a renal dialysis facility. The 10 percent reduction applies for such
ambulance services furnished during the period beginning on October 1,
2013 and ending on September 30, 2018.
This statutory requirement is self-implementing. A plain reading of
the statute requires only a ministerial application of the mandated
rate decrease and does not require any substantive exercise of
discretion on the part of the Secretary. As a result, there were no
policy proposals associated with these legislative provisions or
associated impact in this rule. We are finalizing our proposal without
modification to revise Sec. 414.610(c)(8) to conform the regulations
to this self-implementing statutory requirement.
3. Clinical Laboratory Fee Schedule: Change to the Majority of Medicare
Revenues Threshold in Definition of Applicable Laboratory
As discussed in section III. A. of this final rule, section 1834A
of the Act, as established by section 216(a) of the Protecting Access
to Medicare Act of 2014 (PAMA), required significant changes to how
Medicare pays for Clinical Diagnostic Laboratory Tests (CDLTs) under
the Clinical Laboratory Fee Schedule (CLFS). The CLFS final rule
titled, Medicare Clinical Diagnostic Laboratory Tests Payment System
final rule, published in the Federal Register on June 23, 2016,
implemented section 1834A of the Act. Under the CLFS final rule (81 FR
41036), ``reporting entities'' must report to CMS during a ``data
reporting period'' ``applicable information'' (that is, certain private
payor data) collected during a ``data collection period'' for their
component ``applicable laboratories.'' In general, the payment amount
for each CDLT on the CLFS furnished beginning January 1, 2018, is based
on the applicable information collected during the 6-month data
collection period and reported to us during the 3-month data reporting
period, and is equal to the weighted median of the private payor rates
for the CDLT.
An applicable laboratory is defined at Sec. 414.502, in part, as
an entity that is a laboratory (as defined under the Clinical
Laboratory Improvement Amendments (CLIA) definition at Sec. 493.2)
that bills Medicare Part B under its own National Provider Identifier
(NPI). In addition, an applicable laboratory is an entity that receives
more than 50 percent of its Medicare revenues during a data collection
period from the CLFS and/or the PFS. We refer to this component of the
applicable laboratory definition as the ``majority of Medicare revenues
threshold.'' The definition of applicable laboratory also includes a
``low expenditure threshold'' component which requires an entity to
receive at least $12,500 of its Medicare revenues from the CLFS during
a data collection period, for its CDLTs that are not advanced
diagnostic laboratory tests (ADLTs).
In determining payment rates under the private payor rate-based
CLFS, one of our objectives is to obtain as much applicable information
as possible from the broadest possible representation of the national
laboratory market on which to base CLFS payment amounts, for example,
from independent laboratories, hospital outreach laboratories, and
physician office laboratories, without imposing undue burden on those
entities. We believe it is important to achieve a balance between
collecting sufficient data to calculate a weighted median that
appropriately reflects the private market rate for a CDLT, and
minimizing the reporting burden for entities. In response to
stakeholder feedback and in the interest of facilitating this
objective, we are finalizing the revision to the majority of

[[Page 60033]]

Medicare revenues threshold component in the third paragraph of the
definition of applicable laboratory at Sec. 414.502 to exclude
Medicare Advantage (MA) payments under Medicare Part C from the
definition of total Medicare revenues (that is, the denominator of the
majority of Medicare threshold equation). We believe this change would
increase the opportunity for laboratories with a significant Medicare
Part C revenue component to meet the majority of Medicare revenues
threshold and qualify as an applicable laboratory (provided all other
requirements for applicable laboratory status are met). We believe this
will result in a broader representation of the laboratory industry
reporting applicable information from which to determine payment rates
under the CLFS. For a complete discussion of this revision to the
majority of Medicare revenues threshold component of the definition of
applicable laboratory under the Medicare CLFS, we refer readers to
section III A. of this final rule.
Therefore, in response to stakeholder feedback and in the interest
of obtaining as much applicable information as possible, we are
finalizing the revision of the definition of applicable laboratory at
Sec. 414.502 to include a hospital laboratory that bills Medicare on
the Form CMS-1450 14x bill type and its electronic equivalent. For a
complete discussion of this revision to the definition of applicable
laboratory under the Medicare CLFS, we refer readers to section III.A.
of this final rule.
a. Estimation of Increased Reporting
To estimate the potential impact of excluding MA plan payments from
total Medicare revenues (that is, the denominator of the low
expenditure threshold) on the number of laboratories meeting the
majority of Medicare revenues threshold, using CY 2017 Medicare claims
data, we compared the number of billing NPIs that would have met the
majority of Medicare revenues threshold with MA plan revenues included
in total Medicare revenues (which is the current requirement) versus
the number of billing NPIs that would meet the majority of Medicare
revenues threshold had MA plan payments been excluded from total
Medicare revenues. We found that excluding MA plan payments from total
Medicare revenues increased the level of laboratories meeting the
majority of Medicare revenues threshold by approximately 49 percent. In
other words, we estimate that excluding MA plan payments from total
Medicare revenues (the denominator) of the majority of Medicare
revenues threshold, and keeping the numerator constant (that is
revenues from only the CLFS and or PFS) yields an increase of 49
percent in the number of laboratories meeting the majority of Medicare
revenues threshold.
Our summary analysis of data reporting from the initial data
reporting period under the Medicare CLFS private payor rate-based
payment system, indicates that we received applicable information from
1,942 applicable laboratories and they reported over 4.9 million
records. Applying the projected 49 percent increase to the number of
applicable laboratories from the first data reporting period (1,942 x
1.49) yields an estimated 2,893 laboratories that would meet the
majority of Medicare revenues threshold, which reflects an additional
951 laboratories. Provided all other requirements for applicable
laboratory status are met (including the low expenditure threshold of
receiving at least $12,500 in CLFS revenues during a data collection
period) a laboratory would report applicable information for the next
data reporting period.
To determine the estimated reporting burden for an applicable
laboratory, we looked at the distribution of reported records that
occurred for the first data reporting period. The average number of
records reported for an applicable laboratory for the first data
reporting period was 2,573. The largest amount of records reported for
an applicable laboratory was 457,585 while the smallest amount reported
was 1 record. A summary of the distribution of reported records from
the first data collection period is illustrated in the Table 96.

TABLE 96--Summary of Records Reported for First Data Reporting Period
[By applicable laboratory]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Percentile distribution of records
Total records Average Min records Max records ---------------------------------------------------------------------
records 10th 25th 50th 75th 90th
--------------------------------------------------------------------------------------------------------------------------------------------------------
4,995,877............................... 2,573 1 457,585 23 79 294 1,345 4,884
--------------------------------------------------------------------------------------------------------------------------------------------------------

Presuming that all of the additional laboratories that are
projected to meet the majority of Medicare revenues threshold, that is
approximately 951, also meet all of the criteria necessary to receive
applicable laboratory status, as defined at Sec. 414.502, they would
be an applicable laboratory and report applicable information for the
next data reporting period, January 1, 2020 through March 31, 2020.
Using the mid-point of the percentile distribution of reported records
from the initial data reporting period, that is approximately 300
records reported per applicable laboratory (50th percentile for the
first data reporting period was 294), we estimate an additional 285,300
records would be reported for the next data reporting period (951
laboratories x 300 records per laboratory = 285,300). This represents
an increase in data reporting of about 5 percent over the number of
records reported for the initial data reporting period (285,300
additional records/4,995,877 = 0.05). In other words, using the
approximate mid-point of reported records for the first data reporting
period, we estimate that our proposed change to the majority of
Medicare revenues threshold would increase the total amount of records
reported by approximately 5 percent. As illustrated in Table 96, the
number of records reported varies greatly, depending on the volume of
services performed by a given laboratory. Laboratories with larger test
volumes, for instance at the 90th percentile, should expect to report
more records as compared to the midpoint used for this analysis.
Laboratories with smaller test volume, for instance at the 10th
percentile, should expect to report fewer records as compared to the
midpoint.
We estimate that the inclusion of 14X type of bills would yield an
increase of 39 percent in the total number of laboratories meeting the
majority of Medicare revenues threshold. Applying the projected 39
percent increase to the number of applicable laboratories from the
first data reporting period (1,942 x 1.39) yielded an estimated 2,699
laboratories that would meet the majority of Medicare revenues
threshold, which reflects approximately

[[Page 60034]]

757 additional laboratories. Provided all other required criteria for
applicable laboratory status are met (including the low expenditure
threshold of receiving at least $12,500 in CLFS revenues during a data
collection period) a laboratory would report applicable information for
the next data reporting period. Using the mid-point of the percentile
distribution of reported records from the initial data reporting
period, that is approximately 300 records reported per applicable
laboratory (50th percentile for the first data reporting period was
294), we estimated an additional 221,100 records would be reported for
the next data reporting period (757 laboratories x 300 records per
laboratory = 227,100). This represents an increase in data reporting of
about 5 percent over the number of records reported for the initial
data reporting period (227,100 additional records/4,995,877 = 0.05).
b. Minimal Impact Expected on CLFS Rates
We note that there would only be an associated Medicare cost or
savings to the extent that the additional applicable laboratories are
paid at a higher or lower private payor rate, as compared to other
laboratories that reported previously, and only to the extent that the
volume of services performed by these ``additional'' applicable
laboratories is significant enough to make an impact on the weighted
median of private payor rates. We have no reason to believe that
increasing the level of participation, either by excluding MA plan
payments from total Medicare revenues or including laboratories that
bill Medicare Part B on the Form CMS-1450 14x bill type would result in
a measurable cost difference under the CLFS. Given that the largest
laboratories with the highest test volumes, by definition, dominate the
weighted median of private payor rates, and that the largest
laboratories reported data for the determination of CY 2018 CLFS rates
and are expected to report again, we do not expect the additional
reported data resulting from our proposed change to the majority of
Medicare revenues threshold to have a predictable, direct impact on
CLFS rates because of the reasons stated above. However, we believe
that this proposal responds directly to stakeholder concerns regarding
the number of applicable laboratories reporting applicable information
for the initial data reporting period. Therefore, in an effort to
increase the number of laboratories qualifying for applicable
laboratory status, we are finalizing a change to the majority of
Medicare revenues threshold so that laboratories furnishing tests to a
significant level of Medicare Part C enrollees may qualify as
applicable laboratories and report data to us. In addition, as part of
the same effort to increase the number of laboratories qualifying for
applicable laboratory status, we are finalizing a change in the
definition of applicable laboratory to include an entity that bills
Medicare Part B on the Form CMS-1450 14x bill type. We note that other
laboratory types, such as independent laboratories and physician office
laboratories, are required under the current definition of an
applicable laboratory to determine applicable laboratory status and
must report applicable information. The use of Form CMS-1450 14x TOB to
define an applicable laboratory would assist hospital outreach
laboratories to comply with their obligation to assess applicable
laboratory status for any outreach laboratories and report applicable
information if they meet the requirements to be an applicable
laboratory. As such, the hospital could use the revenues from the CLFS
and PFS as the numerator compared to the total revenues for the 14X TOB
to determine applicable laboratory status. Alternatively, a hospital
could get an NPI for its outreach laboratory.
Comment: One commenter disagreed with our using the number of
laboratories reporting applicable information during the first data
reporting period as a baseline for estimating the number of additional
laboratories that would report applicable information as a result of
excluding MA plan payments under Part C from total Medicare revenues.
The commenter stated that because the OIG estimated that 5 percent of
all laboratories paid under Medicare Part B, or about 12,500
laboratories, would qualify as applicable laboratories and would be
required to report applicable information to CMS. The commenter stated
that because the OIG's estimate is far greater than the number of
laboratories that actually reported (that is 1,942), we should not have
used the number of laboratories reporting applicable information during
the first data reporting period as a baseline.
Response: We believe that it is more appropriate to use the actual
reporting levels (1,942 laboratories) from the initial data reporting
period as a baseline for projecting increased data reporting under our
final policy rather than an estimation of laboratories determined as
applicable. We acknowledge that the OIG estimated that 5 percent of all
laboratories paid under Medicare Part B, or about 12,500 laboratories,
would qualify as applicable laboratories. It is important to note that
individual laboratories determine whether they meet the requirements to
be an applicable laboratory and that neither OIG nor CMS had the
benefit of experience with collecting private payor data before those
estimates were made. We believe that using the actual number of
laboratories that reported is the more reliable method to develop our
estimates of future potential applicable laboratories. We believe that
it is would be inappropriate here to estimate future changes using an
estimate as a baseline when there is actual experience (for example,
number of reporters) that can base used as a baseline.
4. Appropriate Use Criteria for Advanced Diagnostic Imaging Services
Section 1834(q)(2) of the Act, as added by section 218(b) of the
PAMA, established a program to promote the use of AUC for applicable
imaging services furnished in an applicable setting. The CY 2016 PFS
final rule with comment period established an evidence-based process
and transparency requirements for the development of AUC and stated
that the AUC development process requirements, as well as the
application process that organizations must comply with to become
qualified provider-led entities (PLEs) did not impact CY 2016 physician
payments under the PFS (80 FR 71362). The CY 2017 PFS final rule
identified the requirements clinical decision support mechanisms
(CDSMs) must meet for qualification and stated that the CDSM
requirements, as well as the application process that CDSM developers
must comply with for their mechanisms to be specified as qualified
under this program, did not impact CY 2017 physician payments under the
PFS (81 FR 80546). The CY 2018 PFS final rule established the effective
date of January 1, 2020, on which the AUC consulting and reporting
requirements will begin, and extended the voluntary consulting and
reporting period to 18 months. Therefore, we stated these proposals did
not impact CY 2018 physician payments under the PFS (82 FR 53349) and
noted we would provide an impact statement when applicable in future
rulemaking.
This final rule modifies the Medicare AUC Program and addresses the
impacts related to the actions taken by ordering professionals who
order advanced diagnostic imaging services and those who furnish the
advanced diagnostic imaging services, including the professional and
technical portions of the services. We finalized a modification to the
AUC consultation requirement for ordering professionals

[[Page 60035]]

specified in our regulation at Sec. 414.94(j) to allow clinical staff
under the direction of the ordering professional to perform the AUC
consultation; therefore, this analysis estimates the impact of AUC
consultations. We also clarified the requirement that reporting AUC
consultation information across claims for both the furnishing
professional and furnishing facility is required in Sec. 414.94(k),
and this analysis estimates the impact of the statutorily required
reporting AUC consultation information. In addition, we modified the
significant hardship exceptions in Sec. 414.94(i) as proposed,
therefore this analysis estimates the impact of a self-attestation
process for ordering professionals. We also estimated the further
reaching impacts of the AUC program in the detailed analysis that
follows, assuming that some ordering professionals will voluntarily
choose to purchase a qualified CDSM integrated within their existing
electronic health record (EHR) and others may voluntarily choose to
purchase an EHR system in order to obtain an integrated qualified CDSM.
We believe that in the beginning of this program due to the additional
action required on the part of the ordering professional, it may take
longer for a Medicare beneficiary to obtain an order for an advanced
diagnostic imaging service, and therefore, we have calculated an
estimated impact to Medicare beneficiaries.
This final rule includes a discussion of the proposed options along
with the final policy to report the required claims-based AUC
consultation information in the form of G-codes and HCPCS modifiers. We
estimated the impact to use existing coding methods (G-codes and HCPCS
modifiers) to report that information. Finally, we measured the
estimated impact on furnishing professionals and facilities of the
finalized proposal to include independent diagnostic testing facilities
(IDTFs) as an applicable setting in Sec. 414.94(b). While the AUC
consultation and reporting requirements of this program are effective
beginning January 1, 2020 with an educational and operations testing
period, we attempt in this analysis to identify areas of potential
qualitative benefits to both Medicare beneficiaries and the Medicare
program.
a. Impact of Required AUC Consultations by Ordering Professionals
In this final rule, we modified the AUC program largely in response
to public comments and recommendations as we believe these
modifications are also important in minimizing burden of the AUC
program on ordering professionals, furnishing professionals, and
facilities. Specifically, we included a proposal regarding who, other
than the ordering professional, may conduct the AUC consultation
through a qualified CDSM and still meet the requirements of our
regulations. In the CY 2018 PFS final rule (82 FR 53349), we based our
estimate for the AUC consultation requirement on the 2 minute effort of
a family and general practitioner resulting in an annual burden of
1,425,000 hours (43,181,818 consultations (Part B analytics 2014 claims
data) x 0.033 hr/consultation) at a cost of $275,139,000.
An important difference from last year's analysis is that this
year's analysis includes estimates for non-physician practitioners that
order advanced diagnostic imaging services. For the purposes of this
analysis, we assumed that orders for advanced diagnostic imaging
services will be placed by ordering professionals that are non-
physician practitioners in the same percent as the numbers of non-
physician practitioners are relative to the total number of non-
institutional providers. Therefore, this analysis assumed that 40
percent of all advanced diagnostic imaging services will be ordered by
non-physician practitioners. While non-physician practitioners may not
order advanced diagnostic imaging services in the same proportion as
their numbers, we did not have other data to use for this estimate. We
specifically solicited comment and data on alternative assumptions
about the number of non-physician practitioners who order advanced
imaging services. We did not receive comments on this aspect of our
estimate.
In addition, we had proposed, but did not finalize, that auxiliary
personnel may perform the AUC consultation when under the direction of,
and incident to, the ordering professional's services. We finalized
that the AUC consultation task may be delegated by the ordering
professional to clinical staff under the direction of the ordering
professional. The final estimate below, after taking into account
public comments, is applicable given the change in policy from proposed
rule to final rule. In the CY 2019 PFS proposed rule, we estimated that
the majority, or as many as 90 percent, of practices will employ the
use of auxiliary personnel, working under the direction of the ordering
professional, to interact with the CDSM for AUC consultation for
advanced diagnostic imaging orders. We also considered leaving the
policy unchanged, and smaller modifications to that could expand who
performs the consultation to a single type of non-physician
practitioner. We originally proposed this modification because we
believed it maximized burden reduction effort as illustrated in the
following updated estimate of consultation burden.
To estimate the burden of this proposed policy, we calculated the
effort of a 2-minute consultation with a qualified CDSM by a registered
nurse (occupation code 29-1141) with mean hourly wage of $35.36 and 100
percent fringe benefits to be $2.33/consultation ($35.36/hour x 2 x
0.033 hour). If 90 percent of AUC consultations (1,282,500 hours) are
performed by auxiliary personnel as proposed then annually the burden
estimate would be $90,698,400 (1,282,500 hours x $70.72/hour) to
consult. We acknowledged that some AUC consultations will be performed
by the ordering professional, therefore the remaining total annual
burden we estimated was $28,576,950 for the consultation requirement as
it was proposed. As a result of these assumptions and calculations, we
estimated a reduction in the burden of the statutorily required AUC
consultation burden from $275,139,000 (as fully discussed in the CY
2018 PFS final rule) to $122,508,675, which resulted in a net burden
reduction of $152,630,325.
The following is a summary of the comments we received on the
proposed estimated impact of consultations by ordering professionals.
Comment: In general, several commenters found CMS' proposed
estimate of the burden of the Medicare AUC program to be sensible. A
few commenters disagreed with the proposed burden estimate of 2 minutes
to consult a qualified CDSM. One commenter suggested the time was too
short and noted that the Medicare Imaging Demonstration Evaluation
Report to Congress \46\ indicated 3.3 additional minutes to order an
advanced diagnostic imaging service, while another commenter questioned
whether the estimate of burden included calculations for the time and
effort of the ordering professional to look up the CDSM username and
password, wait for web pages to load, conduct the AUC consultation, and
record the results. Additionally, a few commenters stated that more
complex clinical situations will require additional time to perform an
AUC consultation, as well as consultations involving new patients with
new clinical scenarios. In contrast, a few other commenters suggested
that

[[Page 60036]]

the 2 minute estimate to perform AUC consultation overestimated the
time and effort, stating that accessing one no fee website for a
qualified CDSM to perform an AUC consultation takes a healthcare
provider less than 50 seconds.
---------------------------------------------------------------------------

\46\ Timbie JW, Hussey PS, Burgette L, et al. Medicare imaging
demonstration evaluation report for the report to congress. April
2014. RR-706-CMMS.
---------------------------------------------------------------------------

Response: Based on the average of two estimates provided ([3.3 min
+ 0.8 min]/2 = 2.1 min), we continue to believe that 2 minutes is a
reasonable estimate of the time and effort to consult one of the
currently qualified clinical decision support mechanisms available
under this program. We will continue to supplement these estimates with
published evidence as the AUC consultation and reporting requirements
are implemented beginning January 1, 2020.
Comment: A few commenters agreed with our estimates that as many as
90 percent of practices would use other personnel working under the
direction of the ordering professional to interact with the CDSM. One
commenter noted that most family physicians and general practitioners
would not employ a registered nurse for the purpose of AUC consultation
and instead would rely upon a licensed practical nurse or medical
assistant. The commenter also noted that we are likely overestimating
the costs in question because if CMS anticipates a registered nurse is
needed, then such a professional would be cost prohibitive for most
family medicine practices.
Response: As a result of the finalized policy at Sec. 414.94(j)
and after reading the public comments, we have updated our estimate to
account for the $16.15 mean hourly wage and fringe benefits of a
medical assistant (BLS #31-9092) to perform the AUC consultation. If 90
percent of consultations (1,282,500 hours) are performed by such an
individual then annually the burden estimate would be $41,424,750
(1,282,500 hours x $32.30/hour) to consult.
Comment: One commenter suggested that not all clinical situations
will require the ordering professional to consult a CDSM and report the
AUC adherence, but rather noted that first the ordering professional
must determine if the patient's clinical scenario is within a priority
clinical area. Additionally, one commenter stated that additional time
and effort should be considered to estimate the interaction that will
likely be required between the ordering professional and auxiliary
personnel to complete the AUC consultation within the CDSM. Finally,
one commenter suggested that CMS also estimate the time and effort for
the furnishing professional to perform the AUC consultation on behalf
of the ordering professional.
Response: We remind all commenters that an AUC consultation must
take place for any applicable imaging service furnished in an
applicable setting and paid for under an applicable payment system,
regardless of whether the patient's clinical scenario falls within a
priority clinical area. Therefore, we believe that there is not
additional time and effort needed to make this determination as it does
not change the estimation of burden for the AUC consultation
requirement at Sec. 414.94(j). As a result of the finalized policy at
Sec. 414.94(j), the furnishing professional cannot perform the AUC
consultation on behalf of the ordering professional; therefore, we did
not include this additional estimate. When the consultation and
reporting requirements are implemented beginning January 1, 2020, we
may have data to support additional time for other supportive
consultations, such as that between clinical staff and the ordering
professional. However, at this time we have no experience or data to
suggest the type or time of these interactions, and did not receive
estimates or experience from commenters to suggest the level of effort
required to change this AUC consultation burden estimate further.
Comment: A few commenters requested that CMS consider situations
where multiple consultations occur for the same advanced diagnostic
imaging service for the same Medicare beneficiary, such as in the case
of obtaining a second opinion. One commenter expected that the estimate
of burden would include calculations for the time and effort required
of the ordering professional to consult more than one CDSM. Another
commenter noted situations resulting in the Medicare beneficiary being
unable to receive an order during the encounter and forced to return to
the practice such as in the case of technical issues with a CDSM.
Finally, one commenter asked that CMS consider an assumption that some
ordering professionals will decide not to use a qualified CDSM and
instead refer the patient to a specialist for AUC consultation.
Response: If we can consider that a patient is referred to a
specialist in lieu of receiving an order from their general
practitioner, then we recognize that no second consultation would occur
and that a specialist acting as an ordering professional may choose to
delegate the AUC consultation to another individual such as someone on
their clinical staff. If there are technical difficulties that result
in a significant hardship for the ordering professional to consult
specified applicable AUC, then no consultation is required and no
additional time and effort to perform the consultation would take
place. While multiple consultations may take place, such as in the case
of consulting more than one CDSM, it is not a requirement. We will
continue to look for published evidence on these experiences after the
AUC consultation and reporting requirements are implemented beginning
January 1, 2020.
Comment: A few commenters noted that additional costs should be
considered on the part of the ordering professional and/or personnel
under their supervision. One commenter asked that CMS consider the time
and effort to educate ordering professionals and auxiliary personnel on
how to use a CDSM.
Response: We agree with the commenter that we unintentionally
excluded the time and effort to undertake educational training
activities related to performing an AUC consultation. As a result we
have included the time and effort of a general practitioner (occupation
code 29-1062) with mean hourly wage of $100.27 plus 100-percent to
account for fringe benefits to attend a one-time, 1.0 hour training.
The hour is representative of training incurred by physicians for a
single topic as part of the process of maintaining credentials. Some
physicians may not need to undertake educational training activities
related to this program. Others may undertake training activities in
lieu of an alternative continuing education training resulting in no
net increase to their training costs. If all 579,687 ordering
professionals subject to this program attend a one-time, 1.0 hour
training, then we estimate the total burden to be $116,250,431 ($100.27
x 2 x 1.0 hour x 579,687). We recognize that some ordering
professionals may be specialists with higher mean hourly wage and other
ordering professionals are not physicians (for example, nurse
practitioners, physician assistants) with lower mean hourly wage,
however without any additional evidence or specific estimates from
commenters, we could not inform this burden estimate further.
After considering the comments, we are updating the proposed impact
estimate of consultations by ordering professionals. First, we modified
our calculation of the effort by a registered nurse to the effort of a
2-minute consultation with a qualified CDSM by a medical assistant
(occupation code 31-9092) with mean hourly wage of $16.15 and 100
percent fringe benefits

[[Page 60037]]

for 90 percent of consultations (1,282,500 hours) to be $41,424,750
(1,282,500 hours x $32.30/hour). We acknowledged that some AUC
consultations will not be performed by these individuals, therefore the
remaining total annual burden we estimate is $28,576,950 (142,500 hours
x $200.54/hour) for this proposed consultation requirement. As a result
of these assumptions and calculations, we estimated a reduction in
burden of the statutorily required consultation from cost of
$275,139,000 to $70,001,700, which results in a net burden reduction of
$205,137,300.
In section VII.G. of this RIA, Alternatives Considered, we provide
a detailed estimate of the burden of an ordering professional
voluntarily choosing to consult a second, free CDSM for 300,717
services annually. If 90 percent of those consultations (300,717
services x 90 percent x 0.033 hr/service) for 8,931.285 total hours
were performed by a medical assistant at a rate of $32.30/hour for a
total of $288,480.50 (8,931.285 x $32.30/hour) and 10 percent of
consultations (300,717 services x 10 percent x 0.033 hr/service) for
992.376 total hours were performed by the ordering professional at a
rate of $200.54/hour for a total of $199,011.08 then annually the
burden estimate would be 9,923.661 total hours (8,931.285 hours +
992.376 hours) and $487,491.58 ($288,480.50 + $199,011.08) to perform
the second consultation.
We also estimated the burden of this one-time effort to undertake
educational training activities related to the impact of consultations
by ordering professionals. As a result we have included the time and
effort of a general practitioner (occupation code 29-1062) with mean
hourly wage of $100.27 plus 100-percent to account for fringe benefits
to attend a one-time, 1.0 hour training. Based on our proposed estimate
in section VII.F.4.b. of this RIA, if 579,687 ordering professionals
are subject to this program, and all attend training for the same
amount of time, then we estimate the total one-time burden of education
and training to be $116,250,431 ($200.54/hr x 1.0 hour x 579,687).
Since not all physicians would undertake educational training
activities, this estimate should be considered an upper bound.
b. Impact of Significant Hardship Exceptions for Ordering Professionals
We previously identified significant hardship exceptions to the
requirement that ordering professionals consult specified applicable
AUC when ordering applicable imaging services (81 FR 80170). Our
original intention was to design the AUC hardship exception process in
alignment with the EHR Incentive Program and then the MIPS ACI
performance category (now Promoting Interoperability). However, in this
final rule, we modified the significant hardship exception criteria
under Sec. 414.94(i)(3) to be specific to the Medicare AUC program and
independent of other Medicare programs both in policy and process.
Specifically, we finalized the policy that all ordering professionals
self-attest if they are experiencing a significant hardship at the time
of placing an advanced diagnostic imaging order. Since the Medicare EHR
Incentive Program has ended and we are unable to continue referring to
a regulation that is no longer in effect, we did not consider leaving
this policy unchanged. We also considered using a significant hardship
application submission process. However, we believe that the self-
attestation process maximizes burden reduction effort as illustrated in
the following updated estimate of ordering professionals subject to an
AUC consultation burden.
To estimate the impact of our modification and create a hardship
exception specific to this program we attempted to identify how many
ordering professionals would be subject to this program.
Medicare non-institutional Part B claims for the first 6 months of
2014 shows that for claims for an advanced diagnostic imaging service
that listed an NPI for the ordering/referring provider, up to 90-
percent of claims include only 18 different provider specialties. These
specialties include: Emergency Medicine; Internal Medicine; Family
Practice; Cardiology; Hematology/Oncology; Orthopedic Surgery;
Neurology; Urology; Physician Assistant; Nurse Practitioner; Pulmonary
Disease; General Surgery; Neurosurgery; Medical Oncology;
Gastroenterology; Radiation Oncology; Otolaryngology; and Diagnostic
Radiology. We then used CMS data that served to create Table II.8 of
the 2014 Medicare Statistics Book and were able to identify how many
practitioners in each of those specialties were participating in
Medicare program. Table II.8 of the 2014 Medicare Statistics Book
combines many of these specialties into higher level groupings and
displays the total number of practitioners participating in the
Medicare program. However, we used more granular information that
identifies the number of practitioners participating in the Medicare
program by an individual specialty rather than higher level groupings
(table available at https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/CMSProgramStatistics/2016/Downloads/PROVIDERS/2016_CPS_MDCR_PROVIDERS_6.pdf). For example, Table
II.8 of the 2014 Medicare Statistics Book combines all surgeons into
one category whereas we used detailed information for the individual
surgical specialties of general surgery and orthopedic surgery for this
estimate.
Using this more specific data for the 18 specialties, we estimate
the count of practitioners that will be ordering professionals under
the AUC program to be 586,386. There are limitations as we do not have
data on the actual number of practitioners who order advanced
diagnostic imaging services because information about the ordering
professional is not currently required to be included on the Medicare
claim form for advanced diagnostic imaging services.
In the absence of data on the breadth of professionals who would be
required to consult AUC, we assumed that all professionals in the
specialties listed earlier could potentially be subject to these
requirements because some professionals within a specialty may order
these imaging services. We specifically requested comments and data on
the numbers of professionals in the specialties that actually order
advanced imaging services. We did not receive comments on this
estimate.
With respect to the significant hardship exceptions, based on 2016
data from the Medicare EHR Incentive Program and the 2019 payment year
MIPS eligibility and special status file, we estimated that 6,699
respondents in the form of eligible clinicians, groups, or virtual
groups will submit a request for a reweighting to zero for the
advancing care information performance category due to extreme and
uncontrollable circumstances or as a result of a decertification of an
EHR. For the purposes of this analysis, we cautiously estimated that
each of the 6,699 respondents represents a unique ordering professional
and that all respondents who experience extreme and uncontrollable
circumstances or have an EHR that is decertified are ordering
professionals who would self-attest to a significant hardship exception
under the AUC program. Nevertheless, we have used this information to
update our estimate that there are 579,687 ordering professionals
subject to this program.
We believe that the proposed significant hardship exception at

[[Page 60038]]

Sec. 414.94(i) would further reduce the burden of this program as
finalized for four reasons. First, due to the availability of a
significant hardship exception there will likely be fewer ordering
professionals consulting specified applicable AUC. Second, the self-
attestation process is a less burdensome proposal when compared to the
alternative of a hardship application process that may have both
regulatory impact and information collection requirements. We estimate
the impact of a significant hardship exception application in section
VII.G. of this RIA, Alternatives Considered.
Third, any application or case-by-case determination would
necessitate immediate infrastructure development by CMS directly or
through one or more MACs, which adds burden and impact to this program.
Finally, the proposed self-attestation process requires no verification
on the part of the furnishing professional or facility required to
report AUC consultation information on the Medicare claim, thus
minimizing burden for both ordering professionals, furnishing
professionals and facilities. While some of the efficiencies gained
from a self-attestation process are qualitative in nature and difficult
to measure, such as the streamlined reporting, we believe that relative
to other regulatory approaches this proposal uses a least burdensome
approach.
We recognize that ordering professionals would store documentation
supporting the self-attestation of a significant hardship. Storage of
this information could involve the use of automated, electronic, or
other forms of information technology at the discretion of the ordering
professional. We estimated that the average time for office clerical
activities associated with this task to be 10 minutes. To estimate the
burden of this storage, we expected that a Bureau of Labor Statistics
(BLS) occupation title 43-6013 Medical Secretary with a mean hourly
rate of $17.25 and 100-percent fringe benefits would result in a
calculated effort of 10 minutes of clerical work to be $5.76 ($17.25/
hour x 2 x 0.167 hour). If 6,699 separate ordering professionals
require that a Medical Secretary perform the same clerical activity on
an annual basis, then this equates to a cost of approximately $38,596
per year. We solicited comment to inform these burden estimates. We did
not receive comments on these burden estimates and have finalized these
estimates as proposed.
c. Impact of Consultations Beyond the Impact To Ordering Professionals
Although we have already discussed the time and effort to consult
specified applicable AUC through a qualified CDSM here and in previous
rulemaking (81 FR 80170), we believe the impact of this program is
extensive as it will apply to every advanced diagnostic imaging service
(for example, magnetic resonance imaging (MRI), computed tomography
(CT) or positron emission tomography (PET)). Therefore, we also have
described in this detailed analysis the estimated impacts of AUC
consultation beyond the act of consulting specified applicable AUC
which would be an upper bound.
(1) Transfers From Ordering Professionals to Qualified CDSMs and EHR
Systems
The first additional impact we identified is upstream in the
workflow of the AUC consultation and represents the acquisition cost,
training, and maintenance of a qualified CDSM. These tools may be
modules within or available through certified EHR technology (as
defined in section 1848(o)(4)) of the Act or private sector mechanisms
independent from certified EHR technology or established by the
Secretary. Currently, none are established by the Secretary.
Additionally, for the purposes of this program, as required by statute,
one or more of such mechanisms is available free of charge. For this
impact analysis we will illustrate three potential scenarios as low,
medium, and higher burden assessments of this consultation requirement.
First, we assume that some number of ordering professionals consults a
qualified CDSM available free of charge. Second, we assume that some
number purchase a qualified CDSM to integrate within an existing EHR
system. Third, we assume that some do not currently have an EHR system
and, as a result of the statutory requirement to consult with AUC,
would purchase an EHR system with an integrated qualified CDSM to
consult specified applicable AUC for the purposes of this program.
In the lowest estimate of burden, every AUC consultation would take
place using a qualified CDSM available free of charge integrated into
an EHR system and add no additional cost to the requirement in Sec.
414.94(j) of this final rule. While we did not base this estimate on
absolute behaviors by all those who have ordered advanced diagnostic
imaging services, we believe it is reasonable to estimate that as many
as 75 percent of an assumed annual 40,000,000 orders for advanced
diagnostic imaging services could occur at no additional cost beyond
the time and effort to perform the consultation. This may be an
underestimate of orders that occur at no additional cost beyond time
and effort because multiple free qualified CDSMs are available.
In contrast, some ordering professionals may voluntarily choose to
purchase a qualified CDSM that is integrated within their EHR. To
estimate how many ordering professionals may choose to purchase an
integrated qualified CDSM, we consulted the 2015 National Electronic
Health Records Survey \47\ (NEHRS), which is conducted by the National
Center for Health Statistics (NCHS) and sponsored by the Office of the
National Coordinator for Health Information Technology (ONC). NEHRS is
a nationally representative mixed mode survey of office-based
physicians that collects information on physician and practice
characteristics, including the adoption and use of EHR systems. In the
United States in 2015, 86.9 percent of office-based physicians used any
EHR/EMR, with significantly higher adoption by general or family
practice physicians (92.7 percent, p-value <0.05), and slightly lower
for medical non-primary care physicians (84.4 percent). Given that
approximately 87 percent of office-based physicians have adopted EHR
systems, we believe it is likely that the majority will prefer a
qualified CDSM integrated with EHR. While we note that qualified CDSMs
available free of charge are also integrated within one or more EHR
systems, the following illustrative exercise estimates the time and
effort to purchase, install, train, and maintain a qualified CDSM
integrated into an EHR system. Since section 1834(q)(1)(c)(iii)
requires that one or more free CDSMs be available, this is an
illustrative exercise rather than an estimate of the burden of the
statutory requirement.
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\47\ Jamoom E, Yang N. Table of Electronic Health Record
Adoption and Use among Office-based Physicians in the U.S., by
State: 2015 National Electronic Health Records Survey. 2016.
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Again, as stated above, we do not have data on the number of
clinicians who order advanced diagnostic imaging services, and we have
made overarching assumptions to look at particular specialty areas that
in our claims analysis order these advanced diagnostic imaging
services. We assumed all individual clinicians in these specialty areas
could potentially be subject to these requirements. Adding the number
of clinicians in each of the specialty areas results in 586,386
ordering professionals. We also did not make a distinction between
individual

[[Page 60039]]

professionals and groups, as further explained below.
To calculate the impact of a single purchase, we believe based on
market research that ordering professionals, either in groups or
individually, would spend an estimated $15,000 for a one-time purchase
of an integrated qualified CDSM, including installation and training.
We assume that all of these costs are based on market research and
incurred over the course of 5 years. We also assume that the $15,000
purchase would be made by each ordering professional and did not take
into account the potential that a group practice might incur a
discounted price per user based on the number of ordering professionals
in the practice. These assumptions could significantly alter the impact
estimate and we sought comment on such assumptions. Given the difficult
nature of deriving these illustrative estimates based on limited data,
we solicited comment and information on the preference that physicians
and practitioners might have for using an integrated qualified CDSM--a
free CDSM or a CDSM that is not free but integrated within an existing
EHR system. Also, if purchased, whether this would be purchased at the
group practice level to be made available to all clinicians in the
practice for the same cost that would be incurred by a single
practitioner purchasing the same qualified CDSM, and whether the cost
of purchasing a CDSM would be incurred in a single year or over
multiple years.
For the purposes of estimating the transfer of costs from ordering
professionals to qualified CDSM developers, of the estimated 579,687
practitioners that are likely subject to this program, we excluded
181,653 ordering professionals with specialties whose practitioners
order on average fewer than 20 advanced diagnostic imaging services per
year (physician assistant, nurse practitioner, and diagnostic
radiology). The assumption is that lower volume ordering professionals
would select a qualified CDSM that is free of charge. This updates the
estimate to consider 398,034 ordering professionals who may purchase an
integrated qualified CDSM. To this end, if we assume 346,290 (398,034
ordering professionals x 87 percent) ordering professionals already
have an EHR system and 30 percent of these ordering professionals
(346,290 x 30 percent, or 103,887) make this purchase for $15,000 and
spend $1,000 annually to maintain their system for 5 years (initial
acquisition cost in year 1 and maintenance costs in years 2-5), then
the total annual cost is estimated to be $394,770,600 ((103,887 x
$19,000)/5 years)).
It is also reasonable to assume that some ordering professionals
may not need additional training in using a qualified CDSM because the
EHR Incentive Program required CDS as a core measure. In addition, the
EHR Incentive Program incentivized use of computerized provider order
entry (CPOE)--an electronic submission of pharmacy, laboratory, or
radiology orders. To determine readiness among Medicare practitioners
for these and other measures, the 2011 Meaningful Use Census \48\ (RTI
International, 2012) observed that those participating in the EHR
Incentive Program in 2011 on average met and exceeded the established
30 percent threshold for meaningful use of CPOE in Stage 1. Analysis of
the distribution of performance on these measures shows that 86 percent
of eligible participants were well over the established thresholds. It
is important to note that the CPOE measure had a higher threshold in
Stage 2, and 60 percent of eligible participants in 2011 attested to
meaningful use are already meeting this higher threshold. This report
suggests that some ordering professionals may be well prepared to adopt
a qualified clinical decision support mechanism, as this experience
offset may yield lower costs and burden to learn to incorporate
decision support into the ordering workflow through shorter training
times.
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\48\ Vincent, A. EHR Incentive Program: 2011 Meaningful Use
Census. RTI Internatoinal. November 2012.
---------------------------------------------------------------------------

Additionally, some ordering professionals may voluntarily choose to
purchase a certified EHR system to use a qualified CDSM already
integrated within the EHR. The first estimate of capital costs for
certified EHR system was identified in the first year of the EHR
incentive program as an estimated cost of approximately $54,000 (75 FR
44518), which adjusted for inflation using the Consumer Price Index for
All Urban Consumers (CPI-U) U.S. city average series for all items, not
seasonally adjusted, represents $62,050.40 in 2018. If we assume that
346,290 ordering professionals subject to this program have adopted
EHR, then we will also assume that 51,744 ordering professionals
(398,034 ordering professionals x 13 percent) have not adopted an EHR
system.
Most physicians who have not yet invested in the hardware,
software, testing, and training to implement EHRs may continue to work
outside the EHR for a number of reasons--lack of standards, lack of
interoperability, limited physician acceptance among their peers,
maintenance costs, and lack of capital. Adoption of EHR technology
necessitates major changes in business processes and practices
throughout a provider's office or facility. Business process
reengineering on such a scale is not undertaken lightly. Therefore,
while we cannot estimate the business decisions of all ordering
professionals, we assume for the purposes of this analysis that as a
result of this program some ordering professionals will purchase an EHR
system in order to access a qualified CDSM that is integrated into that
EHR system for the purposes of acquiring long-term process efficiencies
in consulting specified applicable AUC.
We do not have data on the characteristics of physicians who have
not purchased an EHR system. However, for the purpose of estimating the
transfer of costs from ordering professionals to EHR systems, we will
assume based on research from business advisors \49\ that 30 percent,
or 15,523 ordering professionals (51,744 ordering professionals x 30
percent) will seek to purchase an EHR system at an estimated cost of
$62,050.40 for a total one-time cost of $963,208,359.20 in EHR system
and integrated qualified CDSM infrastructure. As we believe not every
ordering professional in this example would purchase such
infrastructure immediately, for the purposes of this estimate, we
annualized this cost over 5 years to $192,641,671.84/year. We recognize
that qualified CDSMs may be modules within or available through
certified EHR technology (as defined in section 1848(o)(4) of the Act)
or private sector mechanisms independent from certified EHR technology
or established by the Secretary.
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\49\ McCormack M, ``EHR Software Buyer Report--2014'' available
at https://www.softwareadvice.com/resources/ehr-buyer-report-2014/.
---------------------------------------------------------------------------

We recognize that due to the limited data available to make these
assumptions our estimates are likely high and we sought comment and
information about these assumptions. These estimates might be viewed as
an upper bound of the impact of this program beyond consultation with a
free tool and note that at the time of publication there were three
free tools available as indicated on the CMS website at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/CDSM.html.

[[Page 60040]]

(2) Impact to Medicare Beneficiaries
Additionally, we believe that the additional 2-minute consultation
will impact the Medicare beneficiary when their advanced diagnostic
imaging service is ordered by the ordering professional by introducing
additional time to their office visit. To estimate this annual cost, we
multiplied the annual burden of 1,425,000 hours by the BLS occupation
code that represents all occupations in the BLS (00-0000) as mean
hourly wage plus 100 percent fringe ($47.72/hr) for a total estimate of
$68,001,000 per year. Over time, there may be process efficiencies
implemented in one or more practices similar to the benefits of
deploying CDS \50\ (Berner, 2009; Karsh, 2009) that decrease this
estimate. For example, we will assume that every time an advanced
diagnostic imaging service is ordered, it is the result of a visit by a
Medicare beneficiary for evaluation and management. Then, let us assume
that 50 percent of practices implemented an improvement process that
streamlined the AUC consultation such that Medicare beneficiaries who
visited those practices spent the same amount of time in the
physician's office regardless of whether an advanced diagnostic imaging
service was ordered. As a result of this improvement process in
practice we could estimate such efficiency would offset the estimated
burden by $34,000,500 annually. Although we could not at the time of
the proposed rule identify a concrete solution, we sought comment on
this detailed analysis to inform future rulemaking.
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\50\ Berner ES. Clinical decision support systems: State of the
Art. AHRQ Publication No. 09-0069-EF. Rockville, Maryland: Agency
for Healthcare Research and Quality. June 2009. Karsh B-T. Clinical
practice improvement and redesign: How change in workflow can be
supported by clinical decision support. AHRQ Publication No. 09-
0054-EF. Rockville, Maryland: Agency for Healthcare Research and
Quality. June 2009.
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The following is a summary of the comments we received on the
proposed estimated impact of consultations beyond ordering
professionals.
Comment: Commenters responded to our solicitation for comment and
information on the preference that physicians and practitioners might
have for purchasing an integrated qualified CDSM. One commenter
suggested that CMS did not reasonably estimate the percentage of
practices that would purchase an integrated CDSM relative to using a
free qualified CDSM. This commenter noted that most health systems
prefer to go with a commercial product for accountability, attempted
standardization, and support when a system goes down or requires
updating. To this end, the commenter also asked that CMS estimate the
cost of maintenance to a CDSM. In contrast, another commenter asked
that CMS provide additional information in the final rule as to how it
arrived at the maintenance estimate of $1,000 per year for an
integrated CDSM.
Response: We appreciate these comments acknowledging the challenges
with determining the percentage of practices that would purchase an
integrated CDSM relative to using a free and non-integrated CDSM. While
we did not receive any more precise information to change the estimated
percent of practitioners that would purchase an integrated CDSM, we
will continue to evaluate these estimates as information and published
evidence becomes available once the AUC consultation and reporting
requirements are implemented beginning January 1, 2020. To clarify our
estimate of maintenance, we performed market research by gathering
information from IT experts suggesting annualized costs between 5
percent and 10 percent of initial purchase cost.
Comment: A few commenters questioned the lack of ancillary costs
attributed to the estimation of using a free qualified CDSM. One
commenter cited the need for internet access to use the free tool.
Another commenter cited AUC conferences, town hall meetings, as well as
other forms of professional education to learn about CDSM consultation.
Response: We continue to believe that a free tool is a qualified
CDSM available free of charge. Any ordering professional without
internet access would continue to remain eligible for a significant
hardship exception from performing an AUC consultation and would
instead communicate to the furnishing professional their hardship. We
have included updates to our estimate in this final rule to account for
education and training of all ordering professionals that we estimated
would be subject to this program irrespective of what qualified CDSM is
used to perform the AUC consultation.
After reviewing all comments, for purposes of this RIA we are
finalizing our proposed estimate representing the acquisition cost, and
maintenance of a qualified CDSM. However, we note that these estimates
are based on multiple assumptions, which could change the estimate in
significant ways, and as such may be an overestimate of burden as a
free qualified CDSM is required by law.
d. Considering the Impact of Claims-Based Reporting
In the CY 2018 PFS proposed rule (82 FR 34094), we discussed using
a combination of G-codes and modifiers to report the AUC consultation
information on the Medicare claim. We received numerous public comments
objecting to this potential solution. In the 2018 PFS final rule, we
agreed with many of the commenters that additional approaches to
reporting AUC consultation information on Medicare claims should be
considered, and in the opinion of some commenters, reporting unique
consultation identifiers (UCIs) would be a less burdensome and
preferred approach. We had the opportunity to engage some stakeholders
and we understand that some commenters from the previous rule continue
to be in favor of a UCI. Practically examining the workflow of an order
for an advanced diagnostic imaging service before and after
implementation of the Medicare AUC program, we see that in general the
process remains largely unchanged. Before and after the implementation
of this program, an ordering professional could employ support staff to
transmit an order for an advanced diagnostic imaging service from his
or her office to an imaging facility, physician office, or hospital
that furnishes advanced diagnostic imaging services. After
implementation of this program, the ordering professionals, furnishing
professionals and facilities must adapt this existing workflow to
accommodate new information not previously required on orders for
advanced diagnostic imaging services.
We considered leaving the policy unchanged, and we also considered
writing new regulations requiring larger modifications to the form and
manner by which AUC consultation information is communicated from the
ordering professional to the furnishing professional or facility.
However, we believe this final rule minimizes burden and maximizes
efficiency by reporting through established coding methods, to include
G-codes and modifiers, to report the required AUC information on
Medicare claims.
(1) Impact on Transmitting Order for Advanced Diagnostic Imaging
Services
We estimate that including AUC consultation information on the
order to the furnishing professional or facility is estimated as the
additional 5 minutes spent by a medical secretary (BLS #43-6013) at a
mean hourly rate of $17.25 plus 100 percent fringe to transmit the
order for the advanced diagnostic

[[Page 60041]]

imaging service. Taking into account transmissions through an EHR that
could occur on the order of seconds, a facsimile transmission that
could occur on the order of few minutes, or a telephone call that occur
on the order of several minutes, we believe the estimate of 5 minutes
is an estimate that accounts for different transmittal methods, such as
through an integrated EHR system, by facsimile, or via telephone call
directly to the office of the furnishing professional or facility. In
aggregate, if we assume that 40,000,000 advanced diagnostic imaging
services are ordered annually, then the total annual burden to
communicate additional information in the order is estimated as
$114,540,000 ($17.25/hr x 2 x 0.083 hr x 40,000,000 orders).
(2) Impact on CDSM Developers
While we did not finalize use of a UCI to report AUC consultation
information, the following section remains important to understanding
the impact of standardizing the UCI should we move forward with such
additional modifications in the future.
We believe that in considering a distinct UCI we also considered
updating the requirements of a qualified CDSM in Sec.
414.94(g)(1)(vi)(B). This would incur additional costs for the
developers of these mechanisms to accommodate formatting changes if
instructed by CMS. We continue to believe that participation by CDSM
developers in this program is voluntary, that any considerations of
proposed changes to this policy maximize benefits and minimize burden
to ordering professionals and furnishing professionals and facilities.
Internally, CMS has explored the possibility of using a UCI to
determine feasibility, and provide a detailed estimate of costs to
develop, test, and implement an update in the form and manner of the
UCI generated by the CDSM.
To estimate the costs to develop, test, and implement this update,
we will provide a relevant case study. In 1998, the Year 2000
Information and Readiness Disclosure Act (Pub. L. 105-271, enacted
October 19, 1998) was passed to ensure continuity of operations in the
year 2000. At the time of passage, millions of information technology
computer systems, software programs, and semiconductors were not
capable of recognizing certain dates after December 31, 1999, and
without modification would read dates in the year 2000 and thereafter
as if those dates represented the year 1900 or thereafter, or would
have failed to process those dates entirely. The federal government had
budgeted $8,300,000,000 to continue processing dates in 2000 and beyond
(Department of Commerce, 1999). Additional estimates to repair the date
in a form and manner accommodating the year 2000 varied, but one
estimate \51\ from analysis of the 1998-99 budget bill of the state of
California estimated $241,000,000 to repair 3,000 systems, or
$80,333.33 per system, which adjusted for inflation using the CPI-U,
U.S. city average series for all items, not seasonally adjusted,
represents $123,775.95 per system in 2018. If all 16 qualified CDSMs
performed an update to the formatting of the UCI to appear on
certification or documentation of every AUC consultation, then the one-
time total cost incurred by all CDSM developers would be $1,980,415.20.
Although this does not represent a direct transfer of costs from CDSM
developers to savings and efficiencies for ordering professionals,
furnishing professionals and facilities, we do believe that as a result
of such a policy modification that the ordering professional could
directly communicate a single AUC UCI, and furnishing professionals and
facilities can report UCI in place of identifying each individual CDSM
qualified for the purposes of this program.
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\51\ LAO Analysis of the 1998-99 Budget Bill Information
Technology Issues. Information Technology Issues Analysis of the
1998-99 Budget Bill. The Year 2000 (``Y2K'') Computer Problem.
Published February 18, 1998. Accessed March 25, 2018 at https://www.lao.ca.gov/analysis_1998/info_tech_anl98.html.
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The following is a summary of the comments we received on the
proposed estimated impact of claims-based reporting.
Comment: One commenter noted that there is no standardized form and
manner for submitting the AUC consultation information with the order
for an advanced diagnostic imaging service. This commenter observed
that each imaging facility has its own way of accepting an imaging
order, therefore, the commenter stated it will be burdensome for the
imaging facility to coordinate accurate information for one, let alone
multiple imaging services with the many ordering clinicians from whom
they receive imaging orders. The commenter also stated that facilities
would need to invest considerable resources to develop an appropriate
workflow to comply with this policy, such as additional staff time to
translate AUC consultation information into appropriate codes and
modifiers for billing.
Response: We appreciate this experience of order transmission as we
included in the proposed rule burden estimates for the communication
between staff of the ordering professional to those furnishing the
applicable imaging service ordered in section VII.F.4.d.(1) of this
RIA. We also included in section VII.F.4.e. of the proposed rule a
burden estimate to account for the potential of updates to billing
software to accommodate possible changes in workflow that would
accommodate this policy. As we did not require in this final rule a
specific form and manner standardized to transmit AUC consultation
information, we did not update this area of our burden estimate in this
final rule.
Comment: A few commenters expected additional time estimated for
communication between ordering and furnishing professionals. For
example, one commenter provided the scenario of a furnishing
professional or facility receiving an order for an applicable imaging
service but the order does not contain AUC consultation information. In
another example, a patient obtains an advanced diagnostic imaging
service as part of a clinical trial protocol that does not adhere to
the AUC consulted. To this end, a few commenters requested that CMS
allow the work associated with the additional consultation and
communication time between the ordering and furnishing physicians and
their teams be separately billable for the purposes of the AUC
requirement.
Response: We disagree that additional time for communication
between ordering professionals and those furnishing advanced diagnostic
imaging services should be included for instances where AUC
consultation information was not initially communicated. We remind the
commenters that the estimated burden included communicating AUC
consultation information for all advanced diagnostic imaging services.
In other words, whether the information was initially communicated or
whether there was an initial failure and the information was then
subsequently communicated, that communication has been accounted in our
5 minute estimate per service. We did not propose to authorize a
separately billable service by ordering or furnishing professionals or
their teams to communicate and therefore cannot estimate the cost of
billing Medicare for time to transmit AUC consultation information.
After reviewing the comments, we are finalizing the proposed
estimate of impact of claims based reporting. We note that before and
after the implementation of this program, an ordering professional
could employ support staff to transmit an order for an advanced
diagnostic imaging service

[[Page 60042]]

from his or her office to an imaging facility, physician office, or
hospital that furnishes advanced diagnostic imaging services. As a
result of the flexibility afforded to the means of order communication
and transmission, there are many market-based solutions available to
adapt this existing workflow to accommodate new information not
previously required on orders for advanced diagnostic imaging services.
e. Impact on Furnishing Professionals and Facilities
We expect that an AUC consultation must take place for every
applicable imaging service furnished in an applicable setting and paid
for under an applicable payment system. In the CY 2017 PFS final rule
(81 FR 80170), we codified the definition of applicable setting in
Sec. 414.94(b) to include a physician's office, a hospital outpatient
department (including an emergency department), an ambulatory surgical
center, and any other provider-led outpatient setting determined
appropriate by the Secretary. In this final rule, we finalize as
proposed adding IDTFs to the definition of applicable settings under
this program. This was based on the following factors from 2016 CMS
Statistics: (1) An IDTF is independent both of an attending or
consulting physician's office and of a hospital; (2) diagnostic
procedures when performed by an IDTF are paid under the PFS; (3)
independent facilities have increased 5,120 percent from 4,828 in 1990
to 252,044 in 2015; (4) Of those facilities, 1,125 received total
payments in excess of $100,000 in 2015; (5) there were 37,038 radiology
non-institutional providers utilized by fee-for-service Medicare
beneficiaries for all Part B non-institutional provider services in
2015, of which 14,341 received total payments in excess of $100,000 in
2015. Taken together, we believe this will result in a more even
application of the Medicare AUC program.
To estimate this impact, we assume based on data derived from the
CCW's 2014 Part B non-institutional claim line file, which includes
services covered by the Part B benefit that were furnished during CY
2014, that approximately 40,000,000 advanced diagnostic imaging
services are furnished annually, but questioned whether for the
purposes of this estimate we should attribute equal weight for these
services furnished by each of the following places: (1) A physician's
office; (2) a hospital outpatient department; (3) an ambulatory
surgical center; and (4) an IDTF. Therefore, we sought to determine the
frequency of advanced diagnostic imaging services furnished by each
setting.
For this estimation, we analyzed 2014 Medicare Part B claims data
to weight the various applicable settings subject to this program. For
this estimate, we analyzed a count of total services furnished for the
following 7 Current Procedural Terminology (CPT) codes for advanced
diagnostic imaging studies: 70450--computed tomography, head or brain,
without contrast material; 74177--computed tomography, abdomen and
pelvis, without contrast material; 70553--magnetic resonance (e.g.,
proton) imaging, brain (including brain stem), without contrast
material, followed by contrast material(s) and further sequences;
72148--magnetic resonance (e.g., proton) imaging, spinal canal and
contents, lumbar, without contrast material; 78452--Myocardial
perfusion imaging, tomographic single-photon emission computed
tomography (SPECT) including attenuation correction, qualitative or
quantitative wall motion, ejection fraction by first pass or gated
technique, additional quantification, when performed, multiple studies,
at rest and/or stress (exercise or pharmacologic) and/or redistribution
and/or rest reinjection; 78492--myocardial imaging, positron emission
tomography (PET), perfusion, multiple studies at rest and/or stress;
78803--radiopharmaceutical localization of tumor or distribution of
radiopharmaceutical agent(s), tomographic SPECT; which represented
10,000,000 total services or approximately a 25 percent sample of the
40,000,000 total advanced diagnostic imaging services furnished under
Part B in 2014.
In this sample, we found the following total services and percent
of total services for each of the following settings: (1) Physician's
office, 2,997,460 total services, 28.5 percent; (2) hospital outpatient
department, 7,465,279 total services, 70.9 percent; (3) ambulatory
surgical center, 1,062 total services, 0.01 percent; (4) IDTF, 58,900
total services, 0.6 percent. We also examined whether the total
services furnished in 2015 for each setting increased more than 10
percent from 2014. We found the following total services and percent
change from 2014 for each of the following settings: (1) Physician's
office, 2,944,144 total services, 2 percent decrease; (2) hospital
outpatient department, 7,854,997 total services, 5 percent increase;
(3) ambulatory surgical center, 2,900 total services, 173 percent
increase; (4) IDTF, 65,479 total services, 11 percent increase. Taken
together, we believe these estimates that attribute 70 percent of all
advanced diagnostic imaging services to outpatient, 28 percent to
physician's office, and 1 percent each to ambulatory surgical centers
and independent diagnostic testing facilities, respectively is
generalizable to the total number of visits by Medicare beneficiaries
to each of those applicable settings, respectively.
We do not expect that for the purposes of this program furnishing
professionals and facilities will need to create new billing practices;
however, we assume that the majority of furnishing professionals and
facilities will work to alter billing practices through automation
processes that accommodate AUC consultation information when furnishing
advanced diagnostic imaging services to Medicare beneficiaries.
Therefore, we believe a transfer of costs and benefits will be made
from furnishing professionals and facilities to medical billing
companies to create, test, and implement changes in billing practice
for all affected furnishing professionals and facilities.
As mentioned earlier, the 2016 CMS Statistics identified 37,038
radiology non-institutional providers (Table II.8), and 5,470
ambulatory surgical centers (Table II.5) as of December 31, 2015.
Because the classification of independent facilities includes both
diagnostic radiology and diagnostic laboratory tests, we will assume
that 50 percent of the 252,044 facilities existing in 2015 according to
2016 CMS Statistics (126,022 facilities) furnish advanced diagnostic
imaging services. The American Hospital Association (AHA) Hospital
Statistics published in 2018 by Health Forum, an affiliate of the AHA,
identifies the total number of all U.S. registered hospitals to be
5,534. Taken together, we have identified an estimated 174,064
furnishing professionals (37,038 radiologists + 5,470 ASCs + 126,022
independent diagnostic testing facilities + 5,534 hospitals). We will
assume for the purposes of this calculation that every identified
furnishing professional and facility will choose to update their
processes for the purposes of this program in the same way by
purchasing an automated solution to reporting AUC consultation
information.
The effective date of January 1, 2020 provides some but not
extensive time to prepare to update billing processes to accept and
report AUC consultation information. Requirements at Sec. 414.94(k)
include the following additional information that must be reported: (1)
The qualified CDSM consulted by the ordering professional; (2)
information indicating whether the service ordered would or would not

[[Page 60043]]

adhere to specified applicable AUC, or whether the specified applicable
AUC consulted was not applicable to the service ordered; (3) the NPI of
the ordering professional who consulted specified applicable AUC as
required in paragraph (j) of this section, if different from the
furnishing professional. Although we are not familiar with any
automated billing solution currently available that accommodates this
new information, we based our estimate on medical billing and coding
for experienced professionals (https://www.mb-guide.org/), which
provides estimates ranging from $1,000 to $50,000 for medical billing
software. For example,\52\ the basic Medisoft software program costs
around $1300 while a premium can cost $11,900 for an unlimited amount
of users. In another example,\7\ a simple claims processing interface
through McKesson's Relay Health Clearinghouse costs $200 for
preliminary set up, and added monthly service fees that were not
described explicitly. Therefore, for the purposes of this calculation
such a solution will be estimated to cost each furnishing professional
or facility an estimated $10,000. This estimate is based on the
assumption that the number of available furnishing professionals and
facilities does not equal the number of professionals and facilities
furnishing advanced diagnostic imaging services in the Medicare program
and although we recognize that more than one furnishing professional or
facility may use the same billing service, the combined effectiveness
for an automated solution may decrease overall cost. Although we note
that this estimate is based on certain assumptions, we estimate that
the one-time update will cost $1,740,640,000 (174,064 x $10,000).
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\52\ https://www.mb-guide.org/medical-billing-software-prices.html.
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The Congressional Budget Office estimates that section 218 of the
PAMA would save approximately $200,000,000 in benefit dollars over 10
years from FY 2014 through 2024, which could be the result of
identification of outlier ordering professionals and also includes
section 218(a) of the PAMA--a payment deduction for computed tomography
equipment that is not up to a current technology standard. Because we
have not yet proposed a mechanism or calculation for outlier ordering
professional identification and prior authorization, we are unable to
quantify the impact of prior authorization at this time.
The following is a summary of the comments we received on the
proposed estimated impact on furnishing professionals and facilities.
Comment: A few commenters noted that the Medicare claim form would
change as a result of the Medicare AUC program. These commenters
observed that the electronic claim standard for the institutional
provider (837i) does not capture or have a placeholder for reporting
the ordering physician's NPI. These commenters stated that hospitals
and health systems would need to make sweeping and costly system
changes to interface with a modified 837i as a result.
Response: We appreciate the opportunity to clarify our sentence and
recognize the overlap between reporting AUC consultation information
and standardized communications on Medicare claims forms. The X12N
insurance subcommittee develops and maintains standards for healthcare
administrative transactions on professional (837p), institutional
(837i), and dental (837d) transactions when submitting healthcare
claims for a service or encounter. The current mandated version of 837
transactions is 5010^TM. While we have not finalized a
process for implementing the reporting requirements at Sec. 414.94(k),
we clarify that implementation of changes to the claim form
transactions would not take place outside of the existing process we
described.
After reviewing all comments, we are finalizing our proposed
estimate without modification. However, we note that these estimates
are based on multiple assumptions and as such may be an overestimate of
burden.
f. Appropriate Use Criteria for Advanced Diagnostic Imaging Services
We believe that the first 5 years of this program will be dedicated
to implementation activities, from installation of the technology to
training to operational and behavioral changes. Information on the
benefits of adopting qualified CDSMs or automating billing practices
specifically meeting the requirements in this final rule does not yet
exist--and information on benefits overall is limited. Nonetheless, we
believe there are benefits that can be obtained by ordering
professionals, furnishing professionals and facilities, beneficiaries
and technology infrastructure developers including qualified CDSM
developers, EHR systems developers, and medical billing practices. We
describe these estimated benefits in more detail in the following
sections.
(1) Estimates of Savings
It has been suggested that one-third of imaging procedures are
inappropriate, costing the United States between $3 billion and $10
billion annually \53\ (Stein, 2003). Data derived from the CCW 2014
Part B non-institutional claim line file, which includes services
covered by the Part B benefit that were furnished during CY 2014,
identified approximately $3,300,000,000 in total payments for advanced
diagnostic imaging services. For illustrative purposes, if
implementation of this program were to lead to a 30 percent decrease in
total payments, then we could potentially expect $990,000,000 in fewer
payments annually. To address this suggestion, the insertion of a pause
in the ordering workflow to introduce AUC is a potentially beneficial
and cost-effective solution. Some believe that savings could be
achieved through the reduction of inappropriate orders, and expenses
associated with radiology benefit managers.\54\ Indeed, the Institute
for Clinical Systems Improvement in Bloomington, Minnesota, performed a
clinical decision support pilot project \55\ to (1) improve the utility
of diagnostic radiology tests ordered, (2) reduce radiation exposure,
(3) increase efficiency, (4) aid in shared decision making, and (5)
save Minnesota $84,000,000 in 3 years. While not directly tested in
Miliard et al., we believe this estimate may be generalizable on a
national level and applicable to the Medicare AUC program, as both
activities seek to achieve improvements in quality and decrease costs.
Therefore, if savings estimated in Minnesota were a general
representation of the nation, and on average a single state achieved
50-percent of that representative savings, annualized over 3 years this
estimate could be extrapolated to account for $700,000,000 savings per
year (($84,000,000/3 years) x 50-percent x 50 states). It is
hypothesized \56\ that these benefits are the result of educating
ordering professionals on the appropriate test for a set of clinical
symptoms, rather than just adding time and electronic obstacles between

[[Page 60044]]

ordering physicians and advanced diagnostic imaging services as such
transfer of knowledge can alter clinical practice. The Center for
Health Care Solutions at Virginia Mason Medical Center in Seattle,
Washington examined approaches to control imaging utilization,
including external authorization methods and clinical decision support
systems. A retrospective cohort study \57\ was performed by Blackmore
and colleagues in 2011 of the staged implementation of evidence-based
clinical decision support for the following advanced diagnostic imaging
services: Lumbar MRI; brain MRI; and sinus CT. Brain CT was included as
a control. The number of patients imaged as a proportion of patients
with selected clinical conditions before and after the decision support
interventions were determined from billing data from a regional health
plan and from institutional radiology information systems. The imaging
utilization rates after the implementation of clinical decision support
resulted in decreases for lumbar MRI (p-value = 0.001), head MRI (p-
value = 0.05), and sinus CT (p-value = 0.003), while a decrease in
control service head CT was not statistically significant (p-value =
0.88). Although there are limitations to this retrospective claims data
analysis, the authors concluded that clinical decision support is
associated with large decreases in the inappropriate utilization of
advanced diagnostic imaging services.
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\53\ Stein C. Code red: partners program aims to rein in
skyrocketing costs of diagnostic imaging. Boston Globe, 2003.
\54\ Hardy, K. Decision Support for Rad Reports. Radiology
Today. Vol. 11, No. 1, p. 16., 2010.
\55\ Miliard, M. Nuance, ICSI aim to prevent unnecessary imaging
tests. Healthcare IT News. November 10, 2010.
\56\ Sistrom CL, Dang PA, Weilburg JB, et al., Effect of
Computerized Order Entry with Integrated Decision Support on the
Growth of Outpatient Procedure Volumes: Seven-year Time Series
Analysis. Radiology. 251(1), 2009.
\57\ Blackmore, CC; Mecklenburg, RS; Kaplan GS. Effectiveness of
Clinical Decision Support in Controlling Inappropriate Imaging.
Journal of the American College of Radiology. 8(1) 2011.
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It seems reasonable from this and other studies \58\ of local
implementation of clinical decision support to assume that there may be
some savings when regulations become effective January 1, 2020;
however, there are also a few hesitations to extrapolating these and
other findings broadly to the Medicare population. First, ordering
professionals in this program are aware that CMS will pay for advanced
diagnostic imaging services that do not adhere to the specified
applicable AUC consulted. This awareness may impact the level of
interest or extent of behavior modification from exposing ordering
professionals to a qualified CDSM. Second, the statute distinguishes
between the ordering professional, furnishing professional and
facility, recognizing that the professional who orders an applicable
imaging service is usually not the same professional or facility
reporting to Medicare for that service when furnished. As a result,
some ordering professionals may believe that since they are not
required to submit AUC consultation information directly to CMS, there
are no direct consequences of adhering to specified applicable AUC.
Third, many advanced diagnostic imaging services may not have relevant
or applicable AUC. Indeed a recent study \59\ implementing CDS was only
able to prospectively generate a score for 26 percent and 30 percent of
requests for advanced diagnostic imaging services before and after
implementation of decision support, respectively. Without AUC
available, there can be no decision support intervention into the
workflow of the ordering professional. Fourth, even when an ordering
professional identifies an advanced diagnostic imaging service
recognized as adhering to specified applicable AUC from one qualified
PLE, discordance between AUC from different specialty societies has
been reported,\60\ suggesting that full benefits and savings cannot be
realized without standard levels of appropriateness. Taken together,
these concerns will form the basis for our continued examination of the
impact of this and future rulemaking to maximize the benefits of this
program.
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\58\ Curry, L. and Reed, M.H. Electronic decision support for
diagnostic imaging in a primary care setting. J Am Med Inform Assoc.
2011; 18: 267-270; Ip, I.K., Schneider, L.I., Hanson, R. et al.
Adoption and meaningful use of computerized physician order entry
with an integrated clinical decision support system for radiology:
ten-year analysis in an urban teaching hospital. J Am Coll Radiol.
2012; 9: 129-136.
\59\ Moriarity, AK, Klochko C, O'Brien M, Halabi S. The Effect
of Clinical Decision Support for Advanced Inpatient Imaging. Journal
of American College of Radiology. 12(4) 2015.
\60\ Winchester DE et al., Discordance Between Appropriate Use
Criteria for Nuclear Myocardial Perfusion Imaging from Different
Specialty Societies: a potential concern for health policy. JAMA
Cardiol. 1(2) 2016:207-210.
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(2) Benefits to Medicare Beneficiaries
Although qualified CDSMs are not required to demonstrate that their
tools provide measurable benefits, we believe that as a result of
installation and use, some ordering professionals may find benefits to
the patients they serve. For example, if a qualified CDSM creates a
flag or alert to obsolete tests, then the patient will benefit from
avoiding unnecessary testing. The same outcome would be likely if a
qualified CDSM implemented algorithms that recognize advanced
diagnostic imaging services that may produce inaccurate results because
of medications being taken by the patient. In addition, if the CDSM
provides standardized processes for advanced diagnostic imaging orders
or clarification for confusing test names, then the patient benefits
from a potential decrease in medical errors and less exposure. Finally,
we believe it is reasonable to assume that some improvements in shared
decision making could result from use of a qualified CDSM, because some
CDSMs could provide cost information associated with advanced
diagnostic imaging services and/or identify situations of repeated
testing.
The following is a summary of the comments we received on the
proposed estimated benefits that can be obtained by ordering
professionals, furnishing professionals and facilities, beneficiaries
and technology infrastructure developers including qualified CDSM
developers, EHR systems developers, and medical billing practices.
Comment: A few commenters disagreed that there are any benefits to
the Medicare AUC program. As an example, one commenter submitted their
experience with a CDSM and found that a change in utilization was not
significant. Additionally, a few commenters indicated that every dollar
spent on this program is a dollar that cannot be used elsewhere, more
specifically, for patient care. One commenter disagreed with these
comments, citing a published study \61\ that exposing ordering
professionals to evidence based medicine improves quality and reduces
inappropriate utilization. Another commenter cited several evidence-
based studies ^{15 62 63} that demonstrate the improvement in
the quality of clinical outcomes and reduction of cost resulting from
engagement using AUC.
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\61\ Huber TC, Krishmaraj A, Patrie J, et al. Impact of a
commercially available clinical decision support program on provider
ordering habits. J Am Coll Radiol. 2018:15:951-7.
\62\ Bunt CW, Burke HB, Towbin AJ, et al. Point-of-care
estimated radiation exposure and imaging guidelines can reduce
pediatric radiation burden. J Am Board Fam Med. 2015:28:343-50.
\63\ Tajmir S, Raja AS, Ip IK, et al. Impact of clinical
decision support on radiography for acute ankle injuries: a
randomized trial. West J Emerg Med. 2017:18(3):487-95.
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Response: We thank the commenters for sharing their experience, and
experiences cited in peer-reviewed published literature. This RIA is
presented in conjunction with statutory AUC program requirements. We
provide these estimates in addition to policies that are consistent
with statute and finalized in this rule. However, we note that these
estimates are based on multiple assumptions and as such may be an
overestimate of burden as a free qualified CDSM is available and
required by law.

[[Page 60045]]

5. Medicaid Promoting Interoperability Program Requirements for
Eligible Professionals (EPs) Medicaid Promoting Interoperability
Program Requirements for Eligible Professionals (EPs)
In the Medicaid Promoting Interoperability Program, to keep
electronic clinical quality measure (eCQM) specifications current and
minimize complexity, we proposed to align the eCQMs available for
Medicaid EPs in 2019 with those available for MIPS eligible clinicians
for the CY 2019 performance period. We explained that we anticipated
that this proposal would reduce burden for Medicaid EPs by aligning the
requirements for multiple reporting programs, and that the system
changes required for EPs to implement this change would not be
significant, as many EPs are expected to report eCQMs to meet the
quality performance category of MIPS and therefore should be prepared
to report on those eCQMs for 2019. We explained that we expected that
this proposal would have only a minimal impact on states, by requiring
minor adjustments to state systems for 2019 to maintain current eCQM
lists and specifications. State expenditures to make any systems
changes required as a result of this proposal would be eligible for
ninety percent enhanced Federal financial participation. After careful
consideration of the comments received on this proposal, we are
finalizing it without change. See discussion of comments in section
III.E. of this final rule.
For 2019, we proposed that Medicaid EPs would report on any six
eCQMs that are relevant to the EP's scope of practice, including at
least one outcome measure, or if no applicable outcome measure is
available or relevant, at least one high priority measure, regardless
of whether they report via attestation or electronically. This policy
would generally align with the MIPS data submission requirement for
eligible clinicians using the eCQM collection type for the quality
performance category, which is established in Sec. 414.1335(a)(1).
After careful consideration of the comments received on this proposal,
we are finalizing it without change, and also explain that if no
outcome or high priority measure is relevant to a Medicaid EP's scope
of practice, he or she may report on any six eCQMs that are relevant.
We also proposed that the eCQM reporting period for EPs in the Medicaid
Promoting Interoperability Program would be a full CY in 2019 for EPs
who have demonstrated meaningful use in a prior year, in order to align
with the corresponding performance period for the quality performance
category in MIPS. This proposal is also finalized without change, after
careful consideration of comments received. (See discussion of comments
in section III.E. of this final rule.) We continue to align Medicaid
Promoting Interoperability Program requirements with requirements for
other CMS quality programs, such as MIPS, to the extent practicable, to
reduce the burden of reporting different data for separate programs.
In order to help states to make incentive payments to Medicaid EPs
by December 31, 2021, consistent with section 1903(t)(4)(A)(iii) of the
Act, we proposed to amend Sec. 495.4 to provide that the EHR reporting
period in 2021 for all EPs in the Medicaid Promoting Interoperability
Program would be a minimum of any continuous 90-day period within CY
2021, provided that the end date for this period falls before October
31, 2021, to help ensure that the state can issue all Medicaid
Promoting Interoperability Program payments on or before December 31,
2021. Similarly, we proposed to change the eCQM reporting period in
2021 for EPs in the Medicaid Promoting Interoperability Program to a
minimum of any continuous 90-day period within CY 2021, provided that
the end date for this period falls before October 31, 2021, to help
ensure that the state can issue all Medicaid Promoting Interoperability
Program payments on or before December 31, 2021.
We proposed to allow states the flexibility to set alternative,
earlier final deadlines for EHR or eCQM reporting periods for Medicaid
EPs in CY 2021, with prior approval from CMS, through their State
Medicaid HIT Plans (SMHP). Providing states with the flexibility to set
an alternative, earlier last possible date for the EHR or eCQM
reporting period for Medicaid EPs in 2021 would make it easier for
states to ensure that all payments are made by the December 31, 2021
deadline, especially for states whose prepayment process may take
longer than the 61 days provided for by an October 31, 2021 deadline.
We explained that we expect that this proposal would have only a
minimal impact on states, by requiring minor adjustments to state
systems to meet specifications for the proposed reporting periods,
especially because we are also proposed to permit states to set a
different end date for all EHR and eCQM reporting periods for Medicaid
EPs in 2021. As previously noted, state expenditures for any systems
changes required as a result of this proposal would be eligible for 90
percent enhanced Federal financial participation. After careful
consideration of the comments received on this proposal, as discussed
above in section III.E. of this final rule, we are finalizing it
without change. However, in light of comments received from EPs, we are
also considering whether to propose in future rulemaking that no state
may set a reporting period deadline for CY 2021 that is earlier than
June 30, 2021, or an attestation deadline for CY 2021 that is earlier
than July 1, 2021.
Finally, we proposed changes to the EP Meaningful Use Objective 6,
(Coordination of care through patient engagement) Measure 1 (View,
Download, or Transmit) and Measure 2 (Secure Electronic Messaging), and
to EP Meaningful Use Objective 8, Measure 2 (Syndromic surveillance
reporting). We proposed to amend these measures in response to feedback
about the burdens they create for EPs seeking to demonstrate meaningful
use, and about how they may not be fully aligned with how states and
public health agencies collect syndromic surveillance data. These
proposed amendments were expected to reduce EP burden. Again, we
expected that any changes these proposals might require to state
systems would be minimal and that state expenditures to make any such
changes would also be eligible for 90 percent enhanced federal
financial participation. After careful consideration of the comments
received on these proposals, as discussed in section III.E. of this
final rule, we are finalizing them without change.
6. Medicare Shared Savings Program
In section III.F.1.b. of this final rule, we summarize the proposed
certain modifications to the quality measure set used to assess the
quality of performance of ACOs participating in the Shared Savings
Program. Specifically we proposed: (1) The addition of two Patient
Experience of Care Survey measures, and (2) the removal of four claims-
based outcome measures. After consideration of the comments received,
we are finalizing these proposed modifications to the quality measure
set for the Shared Savings Program in sections III.F. of this final
rule.
The modifications to the Shared Savings Program quality measure set
reduce the number of measures in the Shared Savings Program quality
measure set from 31 to 23 measures, making the quality measure set more
outcome oriented. This reduction in the number of measure is expected
to reduce ACO reporting burden and

[[Page 60046]]

improve quality outcomes for beneficiaries.
7. Physician Self-Referral Law
The physician self-referral law provisions are discussed in section
III.G. of this final rule. We are finalizing regulatory updates to
implement the provisions of section 50404 of the Bipartisan Budget Act
of 2018 pertaining to the writing and signature requirements in certain
compensation arrangement exceptions to the statute's referral and
billing prohibitions. The regulatory language for the writing
requirement reflects current policy, so we do not anticipate that it
will have an impact. We expect that the update regarding temporary non-
compliance with signature arrangements will reduce burden by giving
parties additional time to obtain all required signatures.
8. Changes Due to Updates to the Quality Payment Program
In section III.I. of this final rule, we included our finalized
policies for the Quality Payment Program. In this section of the final
rule, we present the overall and incremental impacts to the number of
expected QPs and associated APM incentive payments. In MIPS, we analyze
the total impact and incremental impact of statutory changes to
eligibility from the Bipartisan Budget Act of 2018, as well as final
policies to expand MIPS eligibility by expanding the MIPS eligible
clinician definition and adding a third criterion for the low-volume
threshold and an opt-in policy option for any clinician that exceeds at
least one, but not all, of the low-volume threshold criteria. Finally,
we estimate the payment impacts by practice size based on various final
policies to modify the MIPS final score, such as the new Promoting
Interoperability performance category policies, for the performance
threshold and additional performance threshold, and as required by the
Bipartisan Budget Act of 2018, the impact of applying the MIPS payment
adjustments to covered professional services (services for which
payment is made under, or is based on, the PFS and that are furnished
by an eligible clinician) rather than items and services covered under
Part B.
The submission period for the first MIPS performance period ended
in early 2018; however, the final data sets were not available in time
to incorporate into the CY 2019 PFS proposed rule analysis (83 FR
36057). We stated in the proposed rule that if technically feasible, we
intended to use data from the CY 2017 MIPS performance period for the
final rule. In this analysis, we have updated our analyses from the
proposed rule to consider data submitted for the 2017 MIPS performance
period (which we refer to in this section as Quality Payment Program
Year 1 data). In section VII.F.8.b. of this final rule, we summarize
the high level findings of updating our model with Quality Payment
Program Year 1 data.
a. Estimated Incentive Payments to QPs in Advanced APMs and Other Payer
Advanced APMs
From 2019 through 2024, through the Medicare Option, eligible
clinicians receiving a sufficient portion of Medicare Part B payments
for covered professional services or seeing a sufficient number of
Medicare patients through Advanced APMs as required to become QPs, for
the applicable performance period, will receive a lump-sum APM
Incentive Payment equal to 5 percent of their estimated aggregate
payment amounts for Medicare covered professional services in the
preceding year. In addition, beginning in payment year 2021, in
addition to the Medicare Option, eligible clinicians may become QPs
through the All-Payer Combination Option. The All-Payer Combination
Option will allow eligible clinicians to become QPs by meeting the QP
thresholds through a pair of calculations that assess a combination of
both Medicare Part B covered professional services furnished through
Advanced APMs and services furnished through Other Payer Advanced APMs.
The APM Incentive Payment is separate from and in addition to the
payment for covered professional services furnished by an eligible
clinician during that year. Eligible clinicians who become QPs for a
year would not need to report to MIPS and would not receive a MIPS
payment adjustment to their Part B PFS payments. Eligible clinicians
who do not become QPs, but meet a slightly lower threshold to become
Partial QPs for the year, may elect to report to MIPS and, if they
elect to report, would then be scored under MIPS and receive a MIPS
payment adjustment, but will not receive the APM Incentive Payment. For
the 2019 Medicare QP Performance Period, we define Partial QPs to be
eligible clinicians in Advanced APMs who collectively have at least 40
percent, but less than 50 percent, of their payments for Part B covered
professional services through an APM Entity, or collectively furnish
Part B covered professional services to at least 20 percent, but less
than 35 percent, of their Medicare beneficiaries through an APM Entity.
If the Partial QP elects to be scored under MIPS, they would be subject
to all MIPS requirements and would receive a MIPS payment adjustment.
This adjustment may be positive, negative or neutral. If an eligible
clinician does not meet either the QP or Partial QP standards, and does
not meet any another exemption category, the eligible clinician would
be subject to MIPS, would report to MIPS, and would receive the
corresponding MIPS payment adjustment.
Beginning in payment year 2026, payment rates for services
furnished by clinicians who achieve QP status for a year would be
increased each year by 0.75 percent for the year, while payment rates
for services furnished by clinicians who do not achieve QP status for
the year would be increased by 0.25 percent. In addition, MIPS eligible
clinicians would receive positive, neutral, or negative MIPS payment
adjustments to payment for their Part B PFS services in a payment year
based on performance during a prior performance period. Although MACRA
amendments established overall payment rate and procedure parameters
until 2026 and beyond, this impact analysis covers only the third
payment year (2021 MIPS payment year) of the Quality Payment Program in
detail.
In section III.I.4.g.(4)(b) of this final rule, we summarized our
finalized policy to add a third alternative to allow requests for QP
determinations at the TIN level in instances where all clinicians who
have reassigned billing rights under the TIN participate in a single
APM Entity. This option will therefore be available to all TINs
participating in Full TIN APMs, such as the Medicare Shared Savings
Program. It will also be available to any other TIN for whom all
clinicians who have reassigned billing rights to the TIN are
participating in a single APM Entity. We also finalized that this third
alternative will only be available to eligible clinicians who meet the
Medicare threshold at the APM Entity level; it will not be available
for eligible clinicians who meet the Medicare threshold individually.
In section III.I.4.g.(4)(c)(ii) of this final rule, we also
discussed our finalized policy to extend the same weighting methodology
to TIN level Medicare Threshold Scores in situations where a TIN is
assessed under the Medicare Option as part of an APM Entity group, and
receives a Medicare Threshold Score at the APM Entity group level. In
this scenario, we believe that the Medicare portion of the TIN's All-
Payer Combination Option Threshold Score should not be lower than the
Medicare Threshold Score that they received by

[[Page 60047]]

participating in an APM Entity group (82 FR 53881 through 53882). We
note this extension of the weighting methodology will only apply to a
TIN when that TIN represents a subset of the eligible clinicians in the
APM Entity, because when the TIN and the APM Entity are the same there
is no need for this weighted methodology. We finalized our proposal to
calculate the TIN's QP Threshold Scores both on its own and with this
weighted methodology, and then use the most advantageous score when
making a QP determination. We believe that, as it does for QP
determinations made at the APM Entity level, this approach promotes
consistency between the Medicare Option and the All-Payer Combination
Option to the extent possible. Additionally, the application of this
weighting approach in the case of a TIN level QP determination is
consistent with our established policy.
These finalized policies affect the estimated number of QPs for the
2021 payment year. We estimate that approximately 8,100 eligible
clinicians in 8 APM Entities representing approximately 225 TINs will
become QPs due to these finalized policies representing TIN level QP
determinations under the All-Payer Combination Option. Therefore, they
will be excluded from MIPS, and qualify for the lump sum incentive
payment based on 5 percent of their Part B allowable charges for
covered professional services, which are estimated to be approximately
$545 million in the 2019 performance year. We also estimated the
corresponding increase of the APM incentive payment of 5 percent of
Part B allowed charges for these QPs will be approximately $27 million
for the 2021 payment year. However, we note that the majority, if not
all, of the 8,100 eligible clinicians that would become QPs if these
policies are finalized, had already attained QP status in the 2018 QP
performance period. Therefore, the associated APM incentive payments
for these 8,100 would not be additional impacts in comparison to
previous performance years, only additional impacts in the absence of
finalizing these proposed policies.
Overall, we estimated that between 165,000 and 220,000 eligible
clinicians will become QPs, therefore be excluded from MIPS, and
qualify for the lump sum incentive payment based on 5 percent of their
Part B allowable charges for covered professional services in the
preceding year, which are estimated to be between approximately $12,000
million and $16,000 million in total for the 2019 performance year. We
estimated that the aggregate total of the APM incentive payment of 5
percent of Part B allowed charges for QPs will be between approximately
$600 and $800 million for the 2021 payment year. The estimated number
of QPs in this final rule is slightly higher than the estimates of
160,000 and 215,000 clinicians included in the proposed rule due to
more updated information being available for the final rule. The
proposed rule used the APM Participation Lists on the most recent MDM
provider extract for the Predictive QP determination file for 2018,
whereas this final rule uses the APM Participation Lists on the most
recent MDM provider extract for the Second QP determination file for
the 2018 performance period. This more updated information did not
significantly change the estimated amount of total Part B allowed
charges and the amount of total APM incentive payments.
We projected the number of eligible clinicians that will be QPs,
and thus excluded from MIPS, using several sources of information.
First, the projections are anchored in the most recently available
public information on Advanced APMs. The projections reflect Advanced
APMs that will be operating during the 2019 QP performance period, as
well as Advanced APMs anticipated to be operational during the 2019 QP
performance period. The projections also reflect an estimated number of
eligible clinicians that would attain QP status through the All-Payer
Combination Option. The following APMs are expected to be Advanced APMs
in performance year 2019: Next Generation ACO Model, Comprehensive
Primary Care Plus (CPC+) Model, Comprehensive ESRD Care (CEC) Model
(Two-Sided Risk Arrangement), Vermont All-Payer ACO Model (Vermont
Medicare ACO Initiative),\64\ Comprehensive Care for Joint Replacement
Payment Model (CEHRT Track), Oncology Care Model (Two-Sided Risk
Arrangements), Medicare ACO Track 1+ Model, Bundled Payments for Care
Improvement Advanced, Maryland Total Cost of Care Model (Maryland Care
Redesign Program; Maryland Primary Care Program), and the Shared
Savings Program Tracks 2 and 3. We used the APM Participant Lists (see
81 FR 77444 through 77445 for information on the APM participant lists
and QP determination) on the most recent MDM provider extract for the
Second QP determination file for 2018 QP performance period to estimate
QPs, total Part B allowed charges for covered professional services,
and the aggregate total of APM incentive payments for the 2019 QP
performance period. We examine the extent to which Advanced APM
participants would meet the QP thresholds of having at least 50 percent
of their Part B covered professional services or at least 35 percent of
their Medicare beneficiaries furnished Part B covered professional
services through the APM Entity.
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\64\ Vermont ACOs are participating in an Advanced APM during
2018 through a version of the Next Generation ACO Model. The Vermont
Medicare ACO Initiative is expected to be an Advanced APM beginning
in CY 2019.
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b. Updates to MIPS Estimates Using Quality Payment Program Year 1 Data
In the CY 2019 PFS proposed rule (83 FR 36058 through 36068), the
RIA modeled MIPS eligibility and performance using data from the
Physician Quality Reporting System (PQRS), the Value Modifier, and the
Medicare/Medicaid EHR Incentive programs to account for the absence of
MIPS performance data. We indicated, that if feasible, we would
integrate performance data from the CY 2017 MIPS performance period
(which we refer to in this section of the final rule as Quality Payment
Program Year 1 data). The model in the 2019 PFS proposed rule had
several assumptions to proxy MIPS performance and we noted the
limitations of the model (83 FR 36067).
In this final rule, we integrated Quality Payment Program Year 1
data into our model estimates and we chose to summarize in this section
important differences or findings that are needed for context when
interpreting the RIA in this final rule. It should be noted that
although we are using Quality Payment Program Year 1 data, the
estimates described in this RIA reflect the impact of the finalized
policies in this final rule and do not reflect actual CY 2017 MIPS
performance period/2019 MIPS payment year results.
First, the Quality Payment Program Year 1 data had more complete
group and individual participation and performance data. In the CY 2019
PFS proposed rule (83 FR 36053 through 36061), we estimated group
reporting solely based on the submission of quality data as a group to
2016 PQRS. For this final rule, we were able to identify group
reporting through submissions to quality, improvement activities or
Promoting Interoperability performance categories. As a result, we
observed higher group reporting than was previously estimated using
PQRS performance data. This finding led to a 42 percent increase (from
approximately 390,000 in the CY 2019 PFS proposed

[[Page 60048]]

rule to 553,000 in this final rule) in group reporters who otherwise
would not have been MIPS eligible clinicians. (See section VII.F.8.c.
for more details on eligibility.) The second benefit of group and
individual level data through the Quality Payment Program Year 1 data
led to our improved ability to better estimate group and individual
scores and to appropriately apply scoring policies at the group and
individual level. (See section VII.F.8.d.(2) for more details on
methodologies for estimating the performance category scores.)
Second, we observed an increase in participation among small
practices than previously estimated in the CY 2019 PFS proposed rule.
The number of clinicians in small practices (who we believe are
estimated to be in MIPS year 3) estimated to submit data increased from
79.7 percent to 89.9 percent. We believe this is related to our
policies for the 2017 MIPS performance period which was designed to
encourage participation, engage clinicians and help them transition
smoothly into MIPS. (See section VII.F.8.d.(3) for more details.)
Third, the Quality Payment Program Year 1 data allowed for the
direct observation of performance for the MIPS performance categories.
With the availability of actual advancing care information and
improvement activities performance category data from the Quality
Payment Program Year 1, we improved our estimates for the Promoting
Interoperability and improvement activities performance category scores
at the individual and group level for the 2019 MIPS performance period/
2021 MIPS payment year. This led to more variation in performance at
the individual and group level for these performance categories
compared to the model in the 2019 PFS proposed rule and to the ability
to accurately assess which clinicians are measured on Promoting
Interoperability or are reweighted (see section III.I.3.h.(5) of this
final rule for more details).
Finally, the Quality Payment Program Year 1 data improved our
ability to estimate who is excluded from MIPS, such as newly enrolled
clinicians. We found that the previous proxy for the CY 2019 PFS
proposed rule overestimated the number of newly enrolled clinicians
than the observed with the Quality Payment Program Year 1 data. As a
result, fewer clinicians were excluded from MIPS compared to the CY
2019 PFS proposed rule. (See section VII.F.8.c.(2) of this final rule
for more details.)
In summary, the estimates presented in the RIA of this final rule
differ from the CY 2019 PFS proposed rule due to our ability to improve
our estimates of eligibility and performance in MIPS. As a result of
data source and methodology changes for the final policies of this
final rule, we observe a slight decrease in final scores. For example,
the mean and median final scores in the CY 2019 PFS proposed rule
analysis were 73.41 and 82.41 respectively,\65\ and the mean and median
in this final rule are 69.53 and 78.72, respectively. As a result, a
higher percentage of clinicians submitting data have scores below the
final performance threshold of 30 points for this final rule (8.8
percent) compared to the CY 2019 PFS proposed rule (3.9 percent). Given
the increase in participation, we are not surprised by these changes.
However, it should be noted we are still using historic data to predict
future performance. Therefore, behaviors due to policies in MIPS Year 1
may not reflect behaviors in Year 3. For example, MIPS eligible
clinicians had to earn 3 out of 100 points to receive at least a
neutral payment adjustment in CY 2017 MIPS performance period/CY 2021
MIPS payment year and therefore may have only submitted a limited
amount of information. As the performance threshold increases in Year
3, we anticipate clinicians will continue to participate and will
likely increase their performance to meet the higher performance
threshold. Therefore, the results presented in this final rule may not
accurately reflect performance for CY 2019 performance period/CY 2021
payment year, which is an important limitation of our findings. See
section VII.F.8.f. for more limitations of this rule.
---------------------------------------------------------------------------

\65\ The mean and median was not published in the CY 2019 PFS
proposed rule RIA, but the methodology is summarized in the CY 2019
PFS proposed rule (83 FR 36058 through 36066).
---------------------------------------------------------------------------

c. Estimated Number of Clinicians Eligible for MIPS Eligibility
(1) Summary of Final Policies Related to MIPS Eligibility and
Application of MIPS Payment Adjustments
In section III.I.3 of this final rule, we finalized three sets of
policy changes that would impact the number of MIPS eligible clinicians
starting with CY 2019 MIPS performance period and the associated CY
2021 MIPS payment year. Two of the changes were finalized as proposed
and affect the low-volume threshold. The third policy affects the
definition of a MIPS eligible clinician and was finalized with
modifications.
In section III.I.3.c.(2) of this final rule, we finalized as
proposed changes to our policy to comply with the Bipartisan Budget Act
of 2018. Specifically, we updated the low-volume threshold starting
with the 2020 MIPS payment year to be based on covered professional
services (services for which payment is made under, or is based on the
PFS and that are furnished by an eligible clinician) rather than items
and services covered under Part B, as provided in section 1848(q)(1)(B)
as amended by section 51003(a)(1)(A)(i) of the Bipartisan Budget Act of
2018. This finalized policy may affect the previously finalized
calculation for the low-volume threshold for certain clinicians because
payment for items, such as Part B drugs, which were previously
considered in the low-volume determination, are now excluded. In
addition, section 51003(a)(1)(E) of the Bipartisan Budget Act of 2018
revised section 1848(q)(6)(E) to apply the MIPS payment adjustments to
covered professional services rather than to items and services covered
under Part B. This change is effective with the 2019 MIPS payment year.
Its effect on the amount of payment adjustments under MIPS is included
in this analysis.
Second, in section III.I.3.a. of this final rule, beginning with
the 2021 MIPS payment year, we finalized with modification the
expansion of the definition of MIPS eligible clinicians to include
physical therapists, occupational therapists, speech-language
pathologists, audiologists, clinical psychologists, and registered
dietitians or nutrition professionals. This finalized list differs from
the proposed list of physical therapists, occupational therapists,
clinical social workers, and clinical psychologists (83 FR 36058).
Specifically, we finalized the definition of MIPS eligible clinician,
as identified by a unique billing TIN and NPI combination used to
assess performance, as any of the following: A physician (as defined in
section 1861(r) of the Act); a physician assistant, nurse practitioner,
and clinical nurse specialist (as such terms are defined in section
1861(aa)(5) of the Act); a certified registered nurse anesthetist (as
defined in section 1861(bb)(2) of the Act), physical therapist,
occupational therapist, speech-language pathologist, audiologist,
clinical psychologist, and registered dietitian or nutrition
professional; and a group that includes such clinicians.
Third, as discussed in sections III.I.3.c.(4) and III.I.3.c.(5) of
this final rule, in addition to the amendments to comply with
Bipartisan Budget Act of 2018, we finalized as proposed our definition
of the low-volume threshold by adding a third criterion (for ``covered

[[Page 60049]]

professional services''). The low-volume threshold now includes a third
criterion: Set at 200 covered professional services to Part B-enrolled
individuals. Taken together, the low-volume threshold is as follows:
(1) Those with $90,000 or less in allowed charges for covered
professional services; or (2) 200 or fewer Part B-enrolled individuals
who are furnished Medicare PFS services; or (3) 200 or fewer covered
professional services. The low volume threshold assessment is applied
at the TIN/NPI level for individual reporting, the TIN level for group
reporting, or the APM Entity Level for reporting under the APM scoring
standard. We also finalized as proposed for any clinician who exceeds
the low-volume threshold on at least one, but not all three, low-volume
threshold criteria may elect to opt-in to MIPS to be measured on
performance, thereby qualifying to receive a positive, neutral, or
negative MIPS payment adjustment based on performance. The absence of
the opt-in election within this cohort means they are not MIPS eligible
clinicians. If a MIPS eligible clinician does not meet at least one of
these low-volume criteria, they are excluded from MIPS. For purposes of
this impact analysis we refer to these revisions to the low-volume
threshold and its application collectively as the ``opt-in policy''.
We discuss how the three finalized policy changes impact MIPS
eligibility and payments, later in this section.
(2) Methodology To Assess MIPS Eligibility
(a) Clinicians Included in the Model Prior to Applying the Low-Volume
Threshold Exclusion
To estimate the number of MIPS eligible clinicians for the CY 2019
performance period in this final rule, our scoring model used the first
determination period from CY 2020 MIPS payment year eligibility file as
described in the CY 2018 Quality Payment Program Final Rule (82 FR
53587 through 53592). The first determination period from the CY 2020
MIPS payment year eligibility file was selected to maximize the overlap
with the performance period data used in the model. In addition, the
low-volume threshold for with the 2020 MIPS payment year was originally
finalized in the CY 2018 Quality Payment Program final rule (82 FR
53587 through 53592) as using Part B items and services, but was later
finalized in section III.I.3.c of this final rule to be based on
covered professional services (services for which payment is made
under, or is based on the PFS and that are furnished by an eligible
clinician). Therefore, this data file provided the information to
calculate a baseline as well as understand the incremental impact of
basing the low-volume threshold on covered professional services rather
than all items and services under Part B. We included 1.5 million
clinicians (see Table 97) who had PFS claims from September 1, 2016 to
August 31, 2017 and included a 30-day claim run-out.We excluded
individual clinicians who were affected by the automatic extreme and
uncontrollable policy finalized for the 2017 MIPS performance period/
2019 MIPS payment year in section III.I.3.i.(2)(b)(ii)(B) of this final
rule as we are unable to predict how these clinicians would perform in
a year where there was no extreme and uncontrollable event.
Clinicians are ineligible for MIPS (and are excluded from MIPS
payment adjustment) if they are newly enrolled to Medicare; are QPs;
are partial QPs who elect to not participate in MIPS; are not one of
the clinician types included in the definition for MIPS eligible
clinician; or do not exceed the low-volume threshold. Therefore, we
excluded these clinicians when calculating those clinicians eligible
for MIPS.
For our baseline population, we restricted to clinicians who are a
physician (as defined in section 1861(r) of the Act); a physician
assistant, nurse practitioner, and clinical nurse specialist (as such
terms are defined in section 1861(aa)(5) of the Act); a certified
registered nurse anesthetist (as defined in section 1861(bb)(2) of the
Act). For the estimated MIPS eligible population for the CY 2021 MIPS
payment year, we added in clinicians who are physical therapists,
occupational therapists, speech-language pathologist, audiologist,
clinical psychologist, and registered dietitian or nutrition
professional.
As noted previously, we excluded QPs from our scoring model, since
these clinicians are not eligible for MIPS. To determine which QPs
should be excluded, we used the QP List for the first snapshot date of
the 2018 QP performance period because these data were available by TIN
and NPI and could be merged into our model. This data also included
participants in APMs, such as the Medicare ACO Track 1+ Model, which
were not available models in the 2017 QP performance period. From this
data, we calculated the QP determinations as described in the
Qualifying APM Participant definition at Sec. 414.1305 for the 2019 QP
performance period. We assumed that all partial QPs would participate
in MIPS and included them in our scoring model and eligibility counts.
The estimated number of QPs excluded from our model is lower than the
projected number of QPs (165,000 to 220,000) for the 2019 QP
performance period due to the expected growth in APM participation. Due
to data limitations, we could not identify specific clinicians who may
become QPs in the 2019 Medicare QP Performance Period; hence, our model
may overestimate the fraction of clinicians and allowed charges for
covered professional services that will remain subject to MIPS after
the exclusions.
We also excluded newly enrolled Medicare clinicians from our model.
To identify newly enrolled Medicare clinicians, we used the indicator
that was used for the 2017 MIPS performance period/2019 MIPS payment
year. The number of newly enrolled clinicians identified using this
approach and data source was approximately one third the estimated
number of newly enrolled clinicians estimated in the proposed rule
which indicates we overestimated the number of newly enrolled
clinicians in the CY 2019 PFS proposed rule impact analysis and that
more clinicians are eligible for MIPS.
In section III.I.3.j.(4)(c) of this final rule, we finalized that
beginning with the 2019 MIPS payment year the MIPS payment adjustment
factors would not apply to certain model-specific payments for the
duration of a section 1115A model's testing. Due to the aggregated data
in our analysis, we were not able to incorporate this policy into our
estimate.
In section III.I.3.j.(4)(d) of the final rule, we finalized the
proposal to waive the payment consequences (positive, negative or
neutral adjustments) of MIPS and to waive the associated MIPS reporting
requirements adopted to implement the payment consequences for certain
participating clinicians in the MAQI Demonstration subject to
conditions outlined in the Demonstration, starting with the 2020 MIPS
payment period. Removing eligible clinicians from MIPS may affect the
payment adjustments for other MIPS eligible clinicians in each year the
waiver is offered. At this time we are unable to identify specific
clinicians that would be affected by this proposal (that is, removed
from the MIPS payment adjustments), but estimate the first year number
of clinicians to be less than 0.1 percent of all MIPS eligible
clinicians. We plan to monitor the impact of the MAQI Demonstration on
payments received by MIPS eligible

[[Page 60050]]

clinicians to whom the waivers do not apply; however, we note that it
may be challenging to draw significant conclusions from such monitoring
as there are many variables that may impact and influence a clinician's
final MIPS adjustment. Due to the lack of information currently
available we are unable to account for this proposal in the eligibility
or payment adjustment tables.
(b) Assumptions Related to Applying the Low-Volume Threshold Exclusion
The low-volume threshold policy may be applied at the individual
(that is, TIN/NPI) or group (that is, TIN or APM entity) levels based
on how data are submitted. If no data are submitted, then the low-
volume threshold is applied at the TIN/NPI level. A clinician or group
that exceeds at least one but not all three low-volume threshold
criteria may become MIPS eligible by electing to opt-in and
subsequently submitting data to MIPS, thereby getting measured on
performance and receiving a MIPS payment adjustment.
Table 97 compares the MIPS eligibility status and the associated
PFS allowed charges from the CY 2019 PFS proposed rule (83 FR 36060)
with the estimates of MIPS eligibility and the associated PFS allowed
charges after using Quality Payment Program Year 1 data and applying
the finalized policies for the CY 2019 MIPS performance period.
For the purposes of modeling, we made assumptions on group
reporting to apply the low-volume threshold. One extreme and unlikely
assumption is that no practices elect group reporting and the low-
volume threshold would always be applied at the individual level.
Although we believe a scenario in which only these clinicians would
participate as individuals is unlikely, this assumption is important
because it quantifies the minimum number of MIPS eligible clinicians.
For final rule model, we estimate there are approximately 217,000
clinicians \66\ who would be MIPS eligible because they exceed the low
volume threshold as individuals and are not otherwise excluded. In
Table 97,\67\ we identify clinicians under this assumption as having
``required eligibility.'' Using this assumption, the number of
clinicians with required eligibility in this final rule and their
associated PFS allowed charges are very similar to the estimate in the
CY 2019 PFS proposed rule (approximately 218,000 clinicians).
---------------------------------------------------------------------------

\66\ The count of 216,612 MIPS eligible clinicians for required
eligibility includes those who participated in MIPS (196,236 MIPS
eligible clinicians) as well as those who did not participate
(17,376 MIPS eligible clinicians).
\67\ Estimates for the proposed rule available at 83 FR 36060.
---------------------------------------------------------------------------

Based on CY 2017 Quality Payment Program Year 1 data, we anticipate
that group and APM Entities that submitted to MIPS as a group and APM
Entity will continue to do so for the CY 2019 MIPS performance period.
Therefore, if we revise our model's group reporting assumption such
that all clinicians that were participating in ACOs in 2017 (including
ACOs participating under the Shared Savings Program or Next Generation
ACO Model) or who reported to the Quality Payment Program Year 1 as a
group would continue to do so in MIPS, then the MIPS eligible clinician
population would be approximately 770,000 clinicians if we only include
the 218,000 required clinicians and the 553,000 clinicians who are only
eligible because of group reporting. In Table 97, we identify these
clinicians who do not meet the low-volume threshold individually but
are anticipated to submit to MIPS as a group based on Quality Payment
Program Year 1 data as having ``group eligibility.'' Updating the data
source for identifying group reporting led to a 42 percent increase
(from approximately 390,000 in the proposed rule to 553,000 in this
final rule) in clinicians in the ``group eligibility'' category. We
also observed a 33 percent increase in the PFS allowed charges in MIPS
from $10,262 million in the proposed rule to $13,662 million in this
final rule for the clinicians in the ``group eligibility'' category.
The previous estimate presented in the proposed rule likely
underestimated the number of clinicians using group reporting since
previously group reporting could only be identified through the
submission of quality data to PQRS. With the availability of CY 2017
Quality Payment Program Year 1 data, we can identify group reporting
through the submission of improvement activities, Promoting
Interoperability, or quality performance category data.To model the
proposed opt-in policy, we assumed that 33 percent of the clinicians
who exceed at least one low-volume threshold and submitted data to CY
2017 MIPS performance period would elect to opt-in to MIPS. We selected
a random sample of 33 percent of clinicians without accounting for
performance. We believe this assumption of 33 percent is reasonable
because some clinicians may choose not to submit data due to
performance, practice size, or resources or alternatively, some may
submit data, but elect to be a voluntary reporter and not be subject to
a MIPS payment adjustment based on their performance. Similar to the
proposed rule (83 FR 36060), we applied a 33 percent opt-in assumption
to estimate opt-in eligibility in this final rule. We sought comment on
these assumptions in the proposed rule, including whether modeling
eligibility only among clinicians or groups who submitted at least 6
quality measures to PQRS would be more appropriate. As we describe in
more detail below, we also explored an alternate opt-in assumption
where only high-performers would opt-in to MIPS. In the alternate
model, we saw a difference in the maximum payment adjustment of
approximately one-tenth of a percent. Given the minimal differences
between the two alternatives, we elected to continue the assumption
from the CY 2019 PFS proposed rule and present results with the 33
percent random opt-in for this impact analysis. This 33 percent
participation assumption is identified in Table 97 as ``Opt-In
eligibility''. In the final rule analysis, we estimate an additional
28,000 clinicians would be eligible through this policy for a total
MIPS eligible population of approximately 798,000. The leads to an
associated $66.6 billion allowed PFS charges estimated to be included
in the 2019 MIPS performance period.
We observed a decrease of approximately 14,000 clinicians compared
to the proposed rule in the ``opt-in eligibility'' category after
updating the data source and applying the finalized policies. This
observed decrease in the number of clinicians that would elect to opt-
in to MIPS is because there were fewer clinicians from which to
randomly select for opt-in eligibility due to the increase in group
reporting.

[[Page 60051]]

Table 97--Description of MIPS Eligibility Status for CY 2021 MIPS Payment Year Using the Proposed and Finalized
Assumptions ***
----------------------------------------------------------------------------------------------------------------
Proposed rule estimates Final Rule estimates [dagger]
Predicted ---------------------------------------------------------------
participation Legacy data * QPP Year 1 data
Eligibility status status in MIPS ---------------------------------------------------------------
among clinicians PFS allowed PFS allowed
* Number of charges ($ in Number of charges ($ in
clinicians mil) **** clinicians mil) ****
----------------------------------------------------------------------------------------------------------------
Required eligibility (always Participate in 186,549 43,546 199,236 47,653
subject to a MIPS payment MIPS. 31,921 7,605 17,376 3,916
adjustment because individual Do not
clinicians exceed the low- participate in
volume threshold in all 3 MIPS.
criteria).
Group eligibility (only Submit data as a 389,670 10,262 553,475 13,662
subject to payment adjustment group.
because clinicians' groups
exceed low-volume threshold
in all 3 criteria and submit
as a group).
Opt-In eligibility assumptions Elect to opt-in 42,025 2,099 27,903 1,380
(only subject to a positive, and submit data.
neutral, or negative
adjustment because the
individual or group exceeds
the low-volume threshold in
at least 1 criterion but not
all 3, and they elect to opt-
in to MIPS and submit data).
---------------------------------------------------------------
Total Number of MIPS ................ 650,165 63,512 ** 797,990 66,611
Eligible Clinicians.
Not MIPS eligible:
Potentially MIPS eligible Do not opt-in; 482,574 11,695 390,244 9,290
(not subject to payment or.
adjustment for non- Do not submit as
participation; could be a group.
eligible for one of two
reasons: 1) meet group
eligibility or 2) opt-in
eligibility criteria).
Below the low-volume Not applicable.. 88,070 690 77,617 404
threshold (never subject
to payment adjustment;
both individual and group
is below all 3 low-volume
threshold criteria).
Excluded for other reasons Not applicable.. 302,172 13,688 209,403 9,735
(Non-eligible clinician
type, newly enrolled, QP).
---------------------------------------------------------------
Total Number of ................ 872,816 26,073 677,264 19,429
Clinicians Not MIPS
Eligible.
---------------------------------------------------------------
Total Number of ................ 1,522,981 89,585 1,475,254 86,040
Clinicians (MIPS and
Not MIPS Eligible).
----------------------------------------------------------------------------------------------------------------
* Participation in MIPS defined as previously submitting quality or EHR data for PQRS. Group reporting based on
2016 PQRS group reporting.
** Updated Estimated MIPS Eligible Population.
*** Facility-based eligible clinicians are not modeled separately in this table and are captured in the
individual eligible category. This table does not consider the impact of the MAQI Demonstration waiver. This
table also does not include clinicians impacted by the automatic extreme and uncontrollable policy
(approximately 22,000 clinicians and $3.7 billion in PFS allowed charges).
[dagger] These estimates reflect the finalized policies, which differ from the proposed rule (that is, change in
MIPS eligible clinician types and those identified as QPs).
**** Allowed charges estimated using 2016 and 2017 dollars. Low-volume threshold is calculated using allowed
charges. MIPS payment adjustments are applied to the paid amount.

There are approximately 390,000 clinicians who are not MIPS
eligible, but could be if their practice decides to participate. We
describe this group as ``Potentially MIPS eligible.'' This is the
unlikely scenario in which all group practices elect to submit data as
a group and all clinicians that could elect to opt-into MIPS do elect
to opt-in. This assumption is important because it quantifies the
maximum number of MIPS eligible clinicians. When this unlikely scenario
is modeled, we estimate that the MIPS eligible clinician population
could be as high as 1.2 million clinicians. We observed a decrease of
approximately 92,000 clinicians compared to the model in the proposed
rule after updating the data source and applying the finalized
policies. This observed decrease is due to the increase in group
reporting.
Finally, there are some clinicians who would not be MIPS eligible
either because they are below the low-volume threshold on all three
criteria (approximately 78,000) or because they are excluded for other
reasons (approximately 209,000). We observed a decrease of
approximately 93,000 clinicians after updating the data source and
applying the finalized policies. This observed decrease is due to much
lower estimated number of newly enrolled clinicians but slightly higher
number of QPs in the 2017 Quality Payment Program Year 1 data.
Since eligibility among some clinicians is contingent on submission
to MIPS as a group or election to opt-in, we will not know the exact
number of MIPS eligible clinicians until the submission period for the
CY 2019 MIPS performance period is closed. For this impact analysis, we
are using the estimated population of 797,990 MIPS eligible clinicians
described above.
We received the following comments on our methodology:
Comment: One commenter requested CMS explain how the number of
clinicians affected by the proposed MIPS opt-in policy for the 2021

[[Page 60052]]

payment year was estimated. The commenter supported the proposed MIPS
opt-in policy starting in 2019 but would like to know how CMS estimated
the number of clinicians that would be impacted by the policy.
Response: For the proposed rule, to estimate the number of
clinicians that may elect to opt-in to MIPS, we randomly selected 33
percent of clinicians that met at least one but not all the low-volume
criteria and submitted data to 2016 PQRS. This led to an estimated
42,025 number of clinicians that will opt-in to MIPS.
For this final rule, we randomly selected 33 percent of clinicians
that met at least one but not all the low-volume criteria and submitted
to CY 2017 MIPS performance period. This led to an estimated 27,903
number of clinicians that will opt-in to MIPS. We also estimated the
impact if we had assumed only those who expect to perform well would
elect to opt-in. In the alternate model assumption where only high
performers would opt-in to MIPS, we assumed 100 percent of clinicians
with final scores above the additional performance threshold would opt-
in and 50 percent of clinicians above the performance threshold but
below the additional performance threshold would opt-in. We observed a
decrease in the budget neutral pool from $310 million to $296 comparing
the model with the 33 percent random opt-in to the model where only
high-performers opt-in. We observed a minimal impact to the maximum
payment adjustment compared to the model with 33 percent random opt-in
(4.7 percent versus 4.6 percent). We refer readers to section
III.I.3.c.(5) of this final rule for additional results on that
analysis. Because we did not see much difference in results, we present
the model with the 33 percent random opt-in this impact analysis.
Comment: One commenter recommended CMS present specialty-specific
data for exemption criteria. Specifically, the commenter recommended
CMS present specialty specific information on the number of clinicians
exempt from MIPS because they are newly enrolled in Medicare and/or
Qualified Participants (QPs) or Partial QPs in Advanced APMs, and the
number of clinicians assigned to certain special categories (for
example, non-patient facing, hospital-based, facility-based, and ASC-
based for the purposes of the ACI exemption). The commenter noted the
provision of this information will allow for the assessment of how many
clinicians are exempt by specialty and for member education activities.
Response: We appreciate that some stakeholders would like specialty
specific information; however, given the numerous assumptions for group
reporting and opt-in participation, we believe presenting the overall
number of MIPS eligible clinicians is the most transparent way to
present the information.
After consideration of the public comments, we have updated our
methodology to estimate the number of MIPS eligible clinicians for the
2019 MIPS performance period/2021 MIPS payment year to account for the
Quality Payment Program Year 1 data and the policies finalized in this
final rule.
(3) Impact of MIPS Eligibility Finalized Policies
We illustrate in Table 98 \68\ how each finalized policy for the CY
2021 payment year affects the estimated number of MIPS eligible
clinicians. The baseline is the number of individuals that would have
been MIPS eligible clinicians for the 2019 MIPS performance period/2021
MIPS payment year if this regulation did not exist. In the CY 2019 PFS
proposed rule (83 FR 36060), we estimated the baseline was 591,010.
After updating the model to reflect the updated data sources, the new
baseline population is 751,498. All incremental impact estimates are
relative to this baseline.
---------------------------------------------------------------------------

\68\ Estimates for the proposed rule available at 83 FR 36061.

Table 98--Incremental Change Table for Finalized Policies for 2021 MIPS Payment Year
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimated Estimated
number of MIPS effect of Estimated Part Estimated PFS
eligible policy changes Estimated % B allowed allowed Estimated %
Policy changes * clinicians on number of change from charges (mil) charges (mil) change in PFS
impacted by MIPS eligible baseline *** *** from baseline
policy change clinicians
--------------------------------------------------------------------------------------------------------------------------------------------------------
Baseline: Applying previously finalized policy for the N/A 751,498 N/A 79,375 64,382 N/A
2021 payment year if this regulation did not exist.....
Policy Change 1: Low-volume threshold (LVT) -1,651 749,847 -0.2 79,160 64,266 -0.2%
determination based on covered professional services
(as required by Bipartisan Budget Act of 2018).........
Policy Change 2: Expansion of eligible clinician types 20,240 770,087 2.5 N/A 65,231 1.3%
to include physical therapists, occupational
therapists, qualified speech-language pathologist, or
qualified audiologist, clinical psychologist, and
registered dietician or nutrition professional based
with policy change 1...................................
Policy Change 3: Cumulative change of Opt-in Policy with 27,903 797,990 6.2 N/A 66,611 3.5%
policy changes 1 and 2 **..............................
--------------------------------------------------------------------------------------------------------------------------------------------------------
* This table does not consider the impact of the MAQI Demonstration waiver and does not include clinicians impacted by the extreme and uncontrollable
policy.
** Model assumption is 33 percent clinicians who are eligible will elect to opt-in.
*** Allowed charges estimated using 2016 and 2017 dollars. Low-volume threshold is calculated using allowed charges. MIPS payment adjustments are
applied to the paid amount.

[[Page 60053]]

First, as shown in Table 98, the first row shows the effect of
changing the application of the MIPS payment adjustments, as required
by section 51003(a)(1)(E) of the Bipartisan Budget Act of 2018 to apply
them to covered professional services (services for which payment is
made under, or is based on, the Medicare PFS and are furnished by an
eligible clinician) rather than to items and services covered under
Part B. As shown, the baseline allowed charges for Part B is $79.4
billion, compared with $64.4 billion in covered professional services,
which is a difference of almost $15 billion. Beginning in the 2019 MIPS
payment year, payment adjustments will only be applied to the total
paid amount for covered professional services.
In Table 98, under the first policy change, basing the low-volume
threshold on covered professional services (services provided under the
PFS rather than items and services covered under Part B) has minimal
impact in terms of clinicians (less than half of one percent decrease).
When the second policy change, to expand the definition of MIPS
eligible clinician types, was added to the first policy change, the
total effect is small. The change in the potential MIPS eligible
clinician population increased by less than 3 percent and the allowed
charges in the PFS increased by 1.3 percent.
When the third policy change, which implements the opt-in policy,
is added to the other two policies, the estimated number of MIPS
eligible clinicians increases by 6.2 percent. The estimated increase in
the allowed charges in the PFS is 3.5 percent.
d. Estimated Impacts on Payments to MIPS Eligible Clinicians
(1) Summary of Approach
In sections III.I.3.h., III.I.3.i. and III.I.3.j. of this final
rule, we finalized several proposals which impact the measures and
activities that impact the performance category scores, final score
calculation, and the MIPS payment adjustment. We discuss these changes
in more detail in section VII.F.8.d.(2) of this RIA as we describe our
methodology to estimate MIPS payments for the 2021 MIPS payment year.
We note that many of the MIPS policies from the CY 2018 Quality Payment
Program final rule were only defined for the 2018 MIPS performance
period and 2020 MIPS payment year (including the performance threshold,
the additional performance threshold, the policy for redistributing the
weights of the performance categories, and many scoring policies for
the quality performance category) which precludes us from developing a
baseline for the 2019 MIPS performance period and 2021 MIPS payment
year if there was no new regulatory action. Therefore, our impact
analysis looks at the total effect of the finalized MIPS policy changes
on the MIPS final score and payment adjustment for CY 2019 MIPS
performance period/CY 2021 MIPS payment year.
The payment impact for a MIPS eligible clinician is based on the
clinician's final score, which is a value determined by their
performance in the four MIPS performance categories: Quality, cost,
improvement activities, and Promoting Interoperability. As described in
the CY 2019 PFS proposed rule (83 FR 36061), the performance and
participation data submitted for the 2017 MIPS performance period were
not available to estimate the final score and the projected payment
adjustments for MIPS eligible clinicians. This analysis has been
updated with the Quality Payment Program Year 1 data and those results
are presented in this final rule. We refer readers to CY 2019 PFS
proposed rule (83 FR 36061 through 36066) for additional details on how
we estimated the final scores and payment adjustments in the proposed
rule.
The estimated payment impacts presented in this final rule reflect
averages by practice size based on Medicare utilization. The payment
impact for a MIPS eligible clinician could vary from the average and
would depend on the combination of services that the MIPS eligible
clinician furnishes. The average percentage change in total revenues
would be less than the impact displayed here because MIPS eligible
clinicians generally furnish services to both Medicare and non-Medicare
patients; this program does not impact payment from non-Medicare
patients. In addition, MIPS eligible clinicians may receive Medicare
revenues for services under other Medicare payment systems, such as the
Medicare Federally Qualified Health Center Prospective Payment System
or Medicare Advantage that would not be affected by MIPS payment
adjustment factors.
(2) Methodology To Assess Impact
To estimate participation in MIPS for the CY 2019 Quality Payment
Program for this final rule, we used CY 2017 Quality Payment Program
Year 1 performance period data. Our scoring model includes the 797,990
estimated number of MIPS eligible clinicians as described in section
VII.F.8.c of this RIA.
To estimate the impact of MIPS on eligible clinicians, we used the
Quality Payment Program Year 1 submission data, including data
submitted for the quality, improvement activities, and advancing care
information performance categories, CAHPS for MIPS and CAHPS for ACOs,
the total per capita cost measure, Medicare Spending Per Beneficiary
(MSPB) measures and other data sets.\69\ We calculated a hypothetical
final score for the 2019 MIPS performance period/2021 MIPS payment year
for each MIPS eligible clinician based on quality, cost, Promoting
Interoperability, and improvement activities performance categories.
---------------------------------------------------------------------------

\69\ 2016 PQRS and Value Modifier data was used for the
improvement score for the quality performance category.
---------------------------------------------------------------------------

Starting in CY 2018 MIPS performance period, solo practitioner or a
group of 10 or fewer eligible clinicians may elect to participate in
MIPS as a virtual group (82 FR 53604). We had two virtual groups
register for the 2018 performance period, of which one had all its
participants participating in a MIPS APM for the 2018 performance
period. While we anticipate an increase in the number of virtual groups
for the 2019 MIPS performance period, we did not attempt to model
virtual groups in this model as the participants in one virtual group
who are in a MIPS APM would receive the MIPS APM score which left just
one virtual group to measure.
(a) Methodology To Estimate the Quality Performance Category Score
We estimated the quality performance category score using measures
submitted to MIPS for the 2017 performance period. For the quality
measures, we started with the assigned measure achievement points
assigned for the 2017 MIPS performance period. As finalized as proposed
in III.I.3.i.(1)(b)(iii)(A) of this final rule, we applied a 3-point
floor for measures that cannot be reliably scored against a baseline
benchmark in the 2019 MIPS performance period. As described in section
III.I.3.h.(2)(b)(iii) of this final rule, we finalized the proposal to
remove many measures that were previously able to be reported in PQRS
and in previous MIPS performance periods. For our estimates, we assumed
that clinicians who reported Medicare Part B claims, eCQM, MIPS CQM and
QCDR measures that are removed would find alternate measures;
therefore, we assigned points to these measures and included them in
our scoring model. For CY 2019, we maintained the policies for

[[Page 60054]]

scoring measures that do not meet the quality category requirements
(case minimum, benchmark, and data completeness) as described in the CY
2018 Quality Payment Program final rule (82 FR 53727 through 53730). As
finalized in the CY 2018 Quality Payment Program final rule, we also
applied a 7-point cap for measures that are topped out for two or more
years (82 FR 53721 through 53727).
As stated in section III.I.3.h.(2)(a)(iii)(A)(bb) of this final
rule, we finalized the proposal to remove several Web Interface
measures. For that collection type, which has a standard set of
measures, we estimated performance on the measures that we propose to
continue.
As finalized in sections III.I.3.i.(1)(b)(ix) and (x) of this final
rule, we maintained the cap on bonus points for high-priority measures
and end-to-end electronic bonus points at 10 percent of the denominator
and, beginning with the 2019 MIPS performance period, discontinue high
priority bonus points for CMS Web Interface Reporters. Because we are
able to use MIPS performance data in our models, we assigned 1 point
for each measure that was submitted with end-to-end electronic
reporting with a cap of 10 percent of the total possible measure
achievement points. To be consistent with our small practice bonus
finalized policy in section III.I.3.i.(1)(b)(viii) of this final rule,
we added 6 measure achievement points to the quality performance
category score for small practices that had a quality performance
category score greater than 0 points.
As finalized in the CY 2018 Quality Payment Program final rule (82
FR 53625 through 52626) and further discussed in III.I.3.h.(2)(a)(iii)
of this final rule, we are allowing MIPS eligible clinicians and groups
to submit data collected via multiple collection types within a
performance category beginning with the 2019 performance period. The
requirements for the performance categories remain the same regardless
of the number of collection types used. We do not apply the validation
process that is discussed in section III.I.3.i.(1)(b)(vii) of this
final rule.
To estimate the impact of improvement for the quality performance
category, we estimated a quality performance category percent score
using 2019 MIPS data, 2015 and 2018 CAHPS for ACOs and MIPS data, and
2016 PQRS VM data. For MIPS eligible clinicians with an estimated
quality performance category score less than or equal to a 30 percent
score in the previous year, we compared 2019 performance to an assumed
2018 quality score of 30 percent for their improvement score as
described in III.I.3.i.(1)(b)(xiii) of this final rule.
Due to data limitations, we are unable to model all the finalized
policies in this rule. We are not able to incorporate the policy to
reduce the denominator for the quality performance category score by 10
points for groups that registered for CAHPS for MIPS but were unable to
report due to insufficient sample size as discussed in section
III.I.3.i.(1)(b)(iii)(B) of this final rule. We also did not apply the
finalized scoring policy for measures that are significantly impacted
by clinical guideline or other changes discussed in section
III.I.3.i.(1)(b)(vi) of this final rule.
Our model applied the MIPS APM scoring standards finalized in
section III.I.3.h.(6) of this final rule to quality data from MIPS
eligible clinicians that participated in the Shared Savings Program,
and the Next Generation ACO Model in 2017.
(b) Methodology To Estimate the Cost Performance Category Score
In section III.I.3.h.(3)(b)(ii) of this final rule, we finalized
the proposal to add 8 episode-based measures to the cost performance
category beginning with the 2019 performance period. For the episode-
based measures, we used the episode specifications proposed in the CY
2019 PFS proposed rule (83 FR 35902 through 35903) and claims data from
June 2016 through May 2017. As discussed in section
III.I.3.h.(3)(b)(ii) of this final rule, we made updates to the
specifications for three episode measures. Due to timing constraints we
were not able to incorporate the updated specifications into this
impact analysis; however, we anticipate that the updates will only have
a marginal effect on the cost measure scores.
We estimated the cost performance category score using the total
per capita cost measure and Medicare Spending Per Beneficiary (MSPB)
measures from the CY 2017 Quality Payment Period Year 1 data that was
presented in the MIPS feedback reports. Cost measure scores were used
only when the associated case size met or exceeded the previously
finalized or newly finalized case minimum: 20 for the total per capita
cost measure, 35 for MSPB, 10 for procedural episodes, and 20 for acute
medical inpatient medical condition episodes. The cost measures are
computed for both the TIN/NPI and the TIN. For clinicians participating
as individuals, the TIN/NPI level score was used if available and if
the minimum case size was met. For clinicians participating as groups,
the TIN level score was used, if available, and if the minimum case
size was met. For clinicians with no measures meeting the minimum case
requirement, we did not estimate a score for the cost performance
category, and the weight for the cost performance category was
reassigned to the quality performance category. The raw cost measure
scores were mapped to scores on the scale of 1-10, using benchmarks
based on all measures that met the case minimum during the relevant
performance period. For the episode-based cost measures, separate
benchmarks were developed for TIN/NPI level scores and TIN level
scores. For each clinician, a cost performance category score was
computed as the average of the measure scores available for the
clinician.
(c) Methodology To Estimate the Facility-Based Measurement Scoring
As discussed in section III.I.3.i.(1)(d) of this final rule, we are
implementing facility-based measurement for the 2019 MIPS performance
period. In facility-based measurement, we determine the eligible
clinician's MIPS score based on Hospital VBP Total Performance Score
for eligible clinicians or groups who meet the eligibility criteria,
which we designed to identify those who primarily furnish services
within a hospital. Given that we are not requiring eligible clinicians
to opt-in to facility-based measurement, it is possible that a MIPS
eligible clinician or a group is automatically eligible for facility-
based measurement but they participate in MIPS as an individual or a
group. In these cases, we use the higher combined quality and cost
performance category score from facility-based scoring compared to the
combined quality and cost performance category score from MIPS
submission based scoring.
Data was not available to attribute specific Hospital VBP Total
Performance Score to MIPS eligible clinicians, hence we made the
following assumptions. For MIPS eligible clinicians and groups who are
eligible for facility-based measurement and who submitted quality data
to the Quality Payment Program for the 2017 MIPS performance period, we
did not estimate a facility-based score. We instead calculated a MIPS
quality and cost score based on the available quality measures and cost
data. Some clinicians who submitted Quality Payment Program quality
data may receive a higher combined quality and cost score through
facility-based measurement, but we are unable to identify those
clinicians due to data limitations and therefore believe the score
based on

[[Page 60055]]

their submitted data is more likely to reflect their performance.
For MIPS eligible clinicians that did not submit data to the
Quality Payment Program for the 2017 MIPS performance period and were
eligible for facility-based measurement, we estimated a facility-based
score by taking the median MIPS quality and cost performance score. We
believe it is important to develop an estimate for this cohort because
we would have otherwise assigned this group a quality performance
category percent score of zero percent which we believe would
underestimate their MIPS final score. Given the data limitations in
assigning a specific hospital score to a clinician, we selected the
median MIPS quality and cost performance scores as that represents the
quality and cost performance category scores that a clinician working
in a hospital with median performance would receive.
(d) Methodology To Estimate the Promoting Interoperability Performance
Category Score
As discussed in section III.I.3.h.(5)(d)(ii) of this final rule, we
finalized the proposal to modify the measures and scoring for the
Promoting Interoperability performance category score. We simplified
scoring by eliminating the concept of base and performance scores and
focusing on a smaller set of measures which are scored on performance.
We estimated Promoting Interoperability performance category scores
using the advancing care information performance category data from the
CY 2017 Quality Payment Period Year 1 data. The Promoting
Interoperability performance category scores were based on the
individual level for individual submissions and on the group level for
clinicians that were part of a group submission or part of an APM
entity.
For the e-Prescribing objective, we only estimated the e-
Prescribing measure and did not assume any bonus points for the Query
of Prescription Drug Monitoring Program (PDMP) or the Verify Opioid
Treatment Agreement measures. To estimate the e-Prescribing measure, we
used the reported numerator and denominator values for the e-
Prescribing measure for the advancing care information performance
category, unless a measure exclusion applied.
For the Health Information Exchange objective, we used the required
measures in the Health Information Exchange objective from the
advancing care information performance category to proxy performance
for the two finalized measures in the Promoting Interoperability
objective. We used the Send Summary of Care measure and the Health
Information Exchange transition measure for the Support Electronic
Referral Loops by Sending Health Information measure. For MIPS eligible
clinicians that reported data using 2015 CEHRT, we used the Request/
Accept Summary of Care measure for the Support Electronic Referral
Loops by Receiving and Incorporating Health Information. If this
information was not available, then we used just the Send Summary of
Care measure. If there was an exclusion for the Send Summary of Care
measure or the Health Information Exchange transition measure, then for
purpose of this model, we reweighted the measure to the Patient
Electronic Access objective.
For the Provider to Patient Exchange objective, we used the Provide
Patient Access measure to estimate performance for the finalized
Provide Patients Electronic Access to Their Health Information measure.
For the Public Health and Clinical Data Exchange objective, we
estimated the score by using the reported responses for the following
advancing care information measures: Immunization Registry Reporting,
Syndromic Surveillance Reporting, Electronic Case Reporting, Public
Health Registry Reporting, Clinical Data Registry Reporting and
Specialized Registry Reporting.
To calculate the Promoting Interoperability performance category,
we summed the performance category measure scores and divided the total
sum by the total number of possible points (100), as described in
section III.I.3.i.(1)(d) of this final rule. As discussed in section
III.I.3.i.(1)(d) of this final rule, a TIN/NPI must report on all
required measures in the Promoting Interoperability performance
category and complete all actions included in the Security Risk
Analysis measure during the year to receive a non-zero performance
category score. For APM Entities, we aggregated the scores of the
participants consistent with the requirements for the 2017 MIPS
performance period.
For eligible clinicians who did not submit a required Promoting
Interoperability measure and did not complete all actions included in
the Security Risk Analysis measure, we evaluated whether the MIPS
eligible clinician could have their Promoting Interoperability
performance category reweighted and applied the reweighting policies
described in section III.I.3.h.(5)(d) of this final rule. For the
Registry Reporting measures, which did not have an exclusion defined
for the 2017 MIPS performance period, we assumed that failure to submit
data or submissions with all ``No'' answers implied a request for
exclusion. A group was only reweighted for the Promoting
Interoperability performance category if all the TIN/NPIs were eligible
for reweighting, thereby reweighting only applying to 24 percent of
MIPS eligible clinicians as opposed to 62 percent of MIPS eligible
clinicians scores in the CY 2019 PFS proposed rule (83 FR 36063) in
which Promoting Interoperability was always assessed at the individual
level.
As finalized in the CY 2017 (81 FR 77069 through 77070) and CY 2018
(82 FR 53625 through 52626) Quality Payment Program final rules, the
Promoting Interoperability performance category weight is set equal to
0 percent, and the weight is redistributed to the quality or
improvement activities performance category for non-patient facing MIPS
eligible clinicians, hospital-based MIPS eligible clinicians, ASC-based
MIPS eligible clinicians, or those who request and are approved for a
significant hardship or other type of exception, including a
significant hardship exception for small practices, or clinicians who
are granted an exception based on decertified EHR technology (82 FR
53780 through 53786). We also finalized in section III.I.3.h.(5)(h) of
this final rule to continue automatic reweighting for NPs, PAs, CNSs
and CRNAs and to add an automatic reweighting policy for physical
therapists, occupational therapist, speech-language pathologists,
audiologists, clinical psychologists, and registered dietitians or
nutrition professionals, which we have incorporated into our model. We
used the non-patient facing and hospital-based indicators and specialty
and small practice indicators as calculated in the initial MIPS
eligibility run for the 2017 MIPS performance period (81 FR 77069
through 77070). For significant hardship exceptions, we used the
approved significant hardship file for the 2017 MIPS performance
period.
If a TIN/NPI did not report on all required measures and did not
qualify for reweighting for a required measure, then their Promoting
Interoperability performance category score was set to zero percent.
(e) Methodology To Estimate the Improvement Activities Performance
Category Score
We modeled the improvement activities performance category score
based on CY 2017 Quality Payment Period Year 1 data and APMs
participation in the 2017 MIPS performance period. We did not make

[[Page 60056]]

any policy changes that impact scoring for the improvement activities
performance category. Our model identified participants in APMs during
the 2017 performance period, including but not limited to those in the
Shared Savings Program, Next Generation ACO Model, and assigned them an
improvement activity score of 100 percent, consistent with our policy
to assign an improvement activities score of 100 percent to ACO
participants who were not excluded due to being QPs.
Clinicians and groups not participating in a MIPS APM were assigned
their CY 2017 Quality Payment Period Year 1 improvement activities
performance category score.
(f) Methodology To Estimate the Complex Patient Bonus
In sections III.I.3.i.(2)(a)(ii) of this final rule, we finalized
the proposed policy to continue the complex patient bonus. Consistent
with the policy to define complex patients as those with high medical
risk or with dual eligibility, our scoring model calculated the bonus
by using the average Hierarchical Condition Category (HCC) risk score,
as well as the MIPS eligible clinician's patients dual eligible
proportion calculated for each NPI in the 2016 Physician and Other
Supplier Public Use File. The dual eligible proportion for each MIPS
eligible clinician was multiplied by 5. We also generated a group
average HCC risk score by weighing the scores for individual clinicians
in each group by the number of beneficiaries they have seen. We
generated group dual eligible proportions using the weighted average
dual eligible patient ratio for all MIPS eligible clinicians in the
groups, which was then multiplied by 5. The complex patient bonus was
calculated by adding together the average HCC risk score and the
percent of dual eligible patients multiplied by 5, with a 5-point cap.
(g) Methodology To Estimate the Final Score
As finalized in sections III.I.3.h.(2)(a)(ii), III.I.3.h.(3)(a),
III.I.3.h.(4)(a), III.I.3.h.(5)(d)(i) and summarized in section
III.I.3.i.(2)(b) of this final rule, our model assigns a final score
for each TIN/NPI by multiplying each performance category score by the
corresponding performance category weight, adding the products
together, multiplying the sum by 100 points, and adding the complex
patient bonus. After adding any applicable bonus for complex patients,
we reset any final scores that exceeded 100 points equal to 100 points.
For MIPS eligible clinicians who were assigned a weight of zero percent
for the Promoting Interoperability due to a significant hardship or
other type of exception, the weight for the Promoting Interoperability
performance category was redistributed to the quality performance
category. For MIPS eligible clinicians who did not have a cost
performance category score, the weight for the cost performance
category was redistributed to the quality performance category. In our
scoring model, we did not address scenarios where a zero percent weight
would be assigned to the quality performance category or the
improvement activities performance category.
(h) Methodology To Estimate the MIPS Payment Adjustment
As described in the CY 2018 Quality Payment Program final rule (82
FR 53785 through 53787), we applied a hierarchy to determine which
final score should be used for the payment adjustment for each MIPS
eligible clinician when more than one final score is available (for
example if a clinician qualifies for a score for an APM entity and a
group score, we select the APM entity score).
We then calculated the parameters of an exchange function in
accordance with the statutory requirements related to the linear
sliding scale, budget neutrality, minimum and maximum adjustment
percentages and additional payment adjustment for exceptional
performance (as finalized under Sec. 414.1405), using a performance
threshold of 30 points and the additional performance threshold of 75
points (as finalized in sections III.I.3.j.(2) and III.I.3.j.(3) of
this final rule). We used these resulting parameters to estimate the
positive or negative MIPS payment adjustment based on the estimated
final score and the PFS paid amount. We considered other performance
thresholds which are discussed in section VII.G. of this RIA.
(3) Impact of Payments by Practice Size
Using the assumptions provided above, our model estimates that $310
million would be redistributed through budget neutrality and that the
maximum positive payment adjustments are 4.7 percent after considering
the MIPS payment adjustment and the additional MIPS payment adjustment
for exceptional performance. The observed decrease in the funds
available for redistribution and the maximum positive payment
adjustment from the proposed rule to the final rule is due to the
change in the data sources used to estimate final scores for MIPS
eligible clinicians and the decrease in the additional performance
threshold.
The use of 2017 Quality Payment Program Year 1 data to estimate the
impact of the 2019 Quality Payment Program Year 3 finalized policies
led to lower average final scores compared to the proposed rule. The
main contributors to the lower estimated final scores were the changes
in the estimated quality and Promoting Interoperability performance
categories scores. The average quality scores were lower because some
of the group reporters did not have quality data. As described in
section VII.F.8.c.(2) of this final rule, we previously identified
group reporters based on the submission of quality data submitted to
PQRS; therefore, all group reporters submitted quality data and had a
quality score. As a result of the 2017 Quality Payment Program Year 1
data, we can identify group reporters through submissions for the
improvement activities or the Promoting Interoperability performance
category who may not have submitted quality data. Therefore, these new
groups in the estimated MIPS population received a zero (or close to
zero) quality performance category score for not submitting quality
data.
Table 99 shows the impact of the payments by practice size and
whether clinicians are expected to submit data to MIPS.\70\ We estimate
that a smaller proportion of clinicians in small practices (1-15
clinicians) who participate in MIPS will receive a positive or neutral
payment adjustment compared to larger size practices. Overall,
clinicians in small practices participating in MIPS would receive a 1.2
percent increase in their paid amount, which is similar to the payment
amount received by MIPS eligible clinicians in practices with 16 to 24
and 25 to 99 clinicians. After considering the positive adjustments and
subtracting the negative adjustments, eligible clinicians in small
practices would have an increase in funds which is consistent with all
MIPS eligible clinicians. Table 99 also shows that 91.2 percent of MIPS
eligible clinicians that participate in MIPS are expected to receive
positive or neutral payment adjustments. The combined impact of
negative and positive adjustments and exceptional performance payment
as percent of paid

[[Page 60057]]

amount among those that do not submit data to MIPS was not the maximum
negative payment adjustment possible because not all MIPS eligible
clinicians that do not submit to MIPS receive a final score of zero.
Indeed, some MIPS eligible clinicians that do not submit data to MIPS
may receive final scores above zero through the cost performance
category, which does not require submission to MIPS. Among those who we
estimate would not submit data to MIPS, 90 percent are in small
practices (15,680 out of 17,376 clinicians). To address participation
concerns, we have policies targeted towards small practices including
technical assistance and special scoring policies to minimize burden
and facilitate small practice participation in MIPS or APMs.
---------------------------------------------------------------------------

\70\ The proposed rule estimated MIPS participation and
performance using historical PQRS and EHR data because MIPS CY 2017
performance period data were not available in time for analysis in
the proposed rule (83 36058 through 36066). This final rule presents
the results from analysis of MIPS CY 2019 performance period data.
Previous estimates are available in the proposed (83 FR 36066).

Table 99--MIPS Estimated Payment Year 2021 Impact on Total Estimated Paid Amount by Participation Status and Practice Size * a
--------------------------------------------------------------------------------------------------------------------------------------------------------
Combined Impact
Percent MIPS of negative and
Percent MIPS eligible Percent MIPS positive
eligible clinicians with a eligible adjustments and
Number of MIPS clinicians with positive clinicians with exceptional
Practice size * eligible positive or adjustment with negative payment performance
clinicians neutral payment exceptional adjustment payment as
adjustment payment (percent) percent of paid
(percent) adjustment amount * *
(percent) (percent)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Among those submitting data * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
(1) 1-15................................................. 140,251 80.1 47.2 19.9 1.2
(2) 16-24................................................ 41,226 86.1 41.4 13.9 1.1
(3) 25-99................................................ 185,140 89.8 48.6 10.2 1.3
(4) 100+................................................. 413,997 96.1 69.0 3.9 2.0
Overall.............................................. 780,614 91.2 58.8 8.8 1.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
Among those not submitting data
--------------------------------------------------------------------------------------------------------------------------------------------------------
(1) 1-15................................................. 15,680 0.0 0.0 100.0 -6.3
(2) 16-24................................................ 629 0.0 0.0 100.0 -6.6
(3) 25-99................................................ 860 0.0 0.0 100.0 -6.6
(4) 100+................................................. 207 0.0 0.0 100.0 -6.9
Overall.............................................. 17,376 0.0 0.0 100.0 -6.4
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Practice size is the total number of TIN/NPIs in a TIN.
** 2016 and 2017 data used to estimate 2019 performance period payment adjustments. Payments estimated using 2016 and 2017 dollars.
*** Includes facility-based clinicians whose quality data is submitted through hospital programs.
\a\ This table does not account for clinicians that are in the MAQI Demonstration waiver.

The following is a summary of the public comments received
regarding the estimated impact on payments for MIPS eligible
clinicians:
Comment: A few commenters encouraged CMS to use Year 1 MIPS
participation data to inform changes to the program, citing that actual
QPP data is needed for assessing the best ways to improve the program
and how these changes will impact clinicians financially.
Response: We thank the commenter for this suggestion. As described
in this RIA for this final rule, the 2017 Quality Payment Program Year
1 data were available in time to assess impact of the finalize policies
and are now presented in this final rule.
Comment: A few commenters recommended CMS present specialty
specific tables. Specifically, they requested the estimated payment
impact table by specialty as presented in previous years and additional
performance data by specialty on each performance category (Data on
reporting and performance rates for quality measures (similar to what
was released via the PQRS Experience Reports); Statistics on clinical
improvement activities reported; Statistics on clinician attribution to
cost measures and performance on cost measures.). This would allow for
better understanding of MIPS for their stakeholders.
Response: We chose to only present the payment impact by practice
size in this final rule; however, we may provide additional analyses
via the Quality Payment Program website or other forums.
After consideration of public comments, we have updated our
analyses to incorporate the Quality Payment Program Year 1 data and the
final policies.
e. Potential Costs of Compliance With the Promoting Interoperability
and Improvement Activities Performance Categories for Eligible
Clinicians
(1) Potential Costs of Compliance With Promoting Interoperability
Performance Category
In section III.I.3.h.(5)(c) of this final rule, we discussed the
requirement to use EHR technology certified to the 2015 Edition
beginning with the 2019 MIPS performance period for the Promoting
Interoperability performance category. As discussed in section V.B.3 of
this final rule, we assumed a slight decrease in overall information
collection burden costs for the Promoting Interoperability performance
category related to having fewer measures to submit.
With respect to any costs unrelated to data submission, although
this final rule would require some investment in systems updates, our
policy prior to this regulation as reflected in Sec. 414.1305, is that
2015 Edition CEHRT will be required beginning with the 2019 MIPS

[[Page 60058]]

performance period/2021 MIPS payment year (82 FR 53671). Therefore, we
do not anticipate any additional costs due to this regulation.
The following is a summary of the public comments received
regarding these assumptions:
Comment: A few commenters stated that complying with Promoting
Interoperability performance category is a financial burden for many
clinicians due to their practice size and their administrative
capability, and the costs required by the EMR and EHR vendors. One
commenter suggested that state and federal legislation ought to take
these challenges into account, while another commenter suggested CMS
work with stakeholders to establish mechanisms for providers to be
compensated for creating interoperable data.
Response: We reiterate that this policy was finalized in the CY
2018 Quality Payment Program final rule (82 FR 53671) and thus this is
not a new obligation for this final rule. We do have policies that
recognize challenges, such as significant hardship exceptions for small
practices.
After consideration of public comments, we are not making any
modifications on our potential cost for compliance with Promoting
Interoperability performance category.
(2) Potential Costs of Compliance With Improvement Activities
Performance Category
Under the policies established in the CY 2017 Quality Payment
Program final rule, the costs for complying with the improvement
activities performance category requirements could have potentially led
to higher expenses for MIPS eligible clinicians. Costs per full-time
equivalent primary care clinician for improvement activities will vary
across practices, including for some activities or certified patient-
centered medical home practices, in incremental costs per encounter,
and in estimated costs per (patient) member per month.
Costs for compliance with previously finalized policies may vary
based on panel size (number of patients assigned to each care team) and
location of practice among other variables. For example, Magill (2015)
conducted a study of certified patient-centered medical home practices
in two states.\71\ That study found that costs associated with a full-
time equivalent primary care clinician, who was associated with
certified patient-centered medical home practices, varied across
practices. Specifically, the study found an average cost of $7,691 per
month in Utah practices, and an average of $9,658 in Colorado
practices. Consequently, incremental costs per encounter were $32.71
for certified patient-centered medical home practices in Utah and
$36.68 in Colorado (Magill, 2015). The study also found that the
average estimated cost per patient member, per month, for an assumed
panel of 2,000 patients was $3.85 in Utah and $4.83 in Colorado.
However, given the lack of comprehensive historical data for
improvement activities, we are unable to quantify those costs in detail
at this time. The findings presented in these papers have not changed.
We have improvement activities information from the 2017 performance
period, but additional analysis would be required before using that
data to report the costs and benefits of implementing the improvement
activities; and we are not able to do this in time for publication of
this final rule. We have considered factors that also contribute to the
difficulty of identifying compliance costs for the improvement
activities performance category in the CY 2018 Quality Payment Program
final rule (82 FR 53845).
---------------------------------------------------------------------------

\71\ Magill et al. ``The Cost of Sustaining a Patient-Centered
Medical Home: Experience from 2 States.'' Annals of Family Medicine,
2015; 13:429-435.
---------------------------------------------------------------------------

We believe that because we finalized an opt-in policy (as described
in section II.C.2.c of this final rule), we would add approximately
28,000 additional clinicians to the MIPS eligible clinicians. In
section V.B.4 of this final rule, we assumed that those who have
elected to opt-in have already been voluntary reporters in MIPS and
would not have additional compliance costs as a result of this
regulation. Thus, we believe the overall potential cost of compliance
would not increase because of this final rule.
Further, we anticipate that the vast majority of clinicians
submitting improvement activities data to comply with existing MIPS
policies could continue to submit the same activities under the
policies established in this final rule. Previously finalized
improvement activities continue to apply for the current and future
years unless otherwise modified per rule-making (82 FR 54175). We refer
readers to Table H in the Appendix of the CY 2017 Quality Payment
Program final rule (81 FR 77177 through 77199) and Tables F and G in
the Appendix of the CY 2018 Quality Payment Program final rule (82 FR
54175 through 54229) for our previously finalized 112 improvement
activities established in the Improvement Activities Inventory. In
section III.I.3.h.(4)(d)(ii) of this final rule, we finalized 6 new
improvement activities, 5 modifications, and 1 removal of an existing
activity.
Similarly, we believe that third parties who submit data on behalf
of clinicians who prepared to submit data in the transition year will
not incur additional costs as a result of this final rule. We requested
comments that provide additional information that would enable us to
quantify the costs, costs savings, and benefits associated with
implementation of improvement activities in the inventory, but did not
receive comments with information that would enable us to quantify the
costs, costs savings, and benefits associated with the implementation
and compliance with the requirements of the improvement activities
performance category: In section III.I.3.h.(4)(e) of this final rule,
we discuss how eligible clinicians can participate in the CMS study on
burdens associated with reporting quality measures for each MIPS
performance period. Eligible clinicians who are interested in
participating can sign up and an adequate sample size is then selected
by CMS from these potential participants. In the CY 2018 Quality
Payment Program final rule, the sample size for the CY 2018 performance
period was set at a minimum of 102 MIPS eligible clinicians (81 FR
77196). Each study participant is required to complete a survey prior
to submitting MIPS data and another survey after submitting MIPS data.
In section III.I.3.h.(4)(e) of this final rule, for the CY 2019
performance period, we finalized the increase to the sample size to a
minimum of 200 MIPS eligible clinicians.
However, we made the focus group a requirement only for a selected
subset of the study participants, using purposive sampling and random
sampling methods, beginning with the CY 2019 performance period and
future years. Completing each survey is estimated to require
approximately 15 minutes; therefore, the annual hourly burden per
participant is approximately 30 minutes. The annual hourly burden
associated with the increase in sample size by 98 clinicians (from 102
clinicians to 200) is estimated to be 49 hours (98 clinicians x 0.5
hours). Using the hourly rate for physicians in section V.A of this
final rule, the total estimated annual cost burden is estimated to be
$10,116 ($206.44/hour x 49 hours). While the sample size of the study
is increasing, we did not make a change to the sample size of MIPS
eligible clinicians participating in the focus group, so no burden is
estimated for participating in that activity. We did

[[Page 60059]]

receive a comment on the burden associated with the study.
f. Assumptions & Limitations
We note several limitations to our estimates of MIPS eligible
clinicians' eligibility and participation, negative MIPS payment
adjustments, and positive payment adjustments for the 2021 MIPS payment
year. We based our analyses on the data prepared to support the 2018
performance period initial determination of clinician and special
status eligibility (available via the NPI lookup on qpp.cms.gov),\72\
participant lists using the APM Participation List for the first
snapshot date of the 2018 QP performance period, CY 2017 Quality
Payment Program Year 1 data and CAHPS for ACOs. The scoring model
results presented in this final rule assume that CY 2017 Quality
Payment Program Year 1 data submissions and performance are
representative of CY 2017 Quality Payment Program Year 3 data
submissions and performance. The scoring model does not reflect the
growth in Advanced APM participation between 2018 and 2019 (Quality
Payment Program Years 2 and 3) because that data is not available at
the detailed level needed for our scoring analysis. The estimated
performance for CY 2019 MIPS performance period using Quality Payment
Program Year 1 data may be underestimated because the performance
threshold to avoid a negative payment adjustment for the 2017 MIPS
performance period/2019 MIPS payment year was significantly lower (3
out of 100 points) than the performance threshold for the 2019 MIPS
performance period/2021 MIPS payment year (30 out of 100). We
anticipate clinicians may submit more performance categories to meet
the higher performance threshold to avoid a negative payment
adjustment.
---------------------------------------------------------------------------

\72\ The time period for this eligibility file (September 1,
2016 to August 31, 2017) maximizes the overlap with the performance
data in our model.
---------------------------------------------------------------------------

In our MIPS eligible clinician assumptions, we assumed that 33
percent of the opt-in eligible clinicians that participated in the CY
2017 Quality Payment Program Year 1 would elect to opt-in to the MIPS
program. It is difficult to predict whether clinicians will elect to
opt-in to participate in MIPS with the finalized policy.
There are additional limitations to our estimates: (1) We only
estimated the potential impact of facility-based scoring for MIPS
eligible clinicians that are eligible for facility-based measurement
and would have a quality performance category score of zero from
failure to submit quality data; (2) because we used historic data, we
assumed participation in the three performance categories in MIPS Year
1 would be similar to MIPS Year 3 performance; and (3) to the extent
that there are year-to-year changes in the data submission, volume and
mix of services provided by MIPS eligible clinicians, the actual impact
on total Medicare revenues will be different from those shown in Table
99. Due to the limitations described, there is considerable uncertainty
around our estimates that is difficult to quantify in detail.
9. Medicare Shared Savings Program; Accountable Care Organizations--
Pathways to Success
This final rule includes certain provisions originally proposed for
the Medicare Shared Savings Program (Shared Savings Program) in a
proposed rule titled ``Medicare Program; Medicare Shared Savings
Program; Accountable Care Organizations--Pathways to Success''
(hereinafter referred to as the ``August 2018 proposed rule'') that
appeared in the Federal Register on August 17, 2018 (83 FR 41786). As
described in section V. of this final rule, certain provisions of the
August 2018 proposed rule are being finalized in this final rule in
order to ensure that certain payment and policy changes for the
Medicare Shared Savings Program are in place prior to the start of
performance years under the program that begin on January 1, 2019. In a
forthcoming final rule, we anticipate summarizing and responding to
public comments on the remaining proposals in the August 2018 proposed
rule that are not addressed in this final rule.
The most consequential of the changes to the Medicare Shared
Savings Program being finalized in this final rule is the option for
existing ACOs whose agreement periods expire on December 31, 2018, to
elect an extension to their current agreement period for a fourth
performance year, defined as the period from January 1, 2019, through
June 30, 2019. Absent the voluntary 6-month extension as finalized in
this rule, approximately 203 ACOs would be required to leave the
program at least temporarily until the availability of an opportunity
to enter a new agreement period for program participation. We estimate
that up to 200 ACOs would elect the extension for the first 6 months of
2019, and therefore, would continue to improve care coordination and
efficiency, and have the opportunity to receive shared savings for such
period estimated to total approximately $170 million. As noted in the
August 2018 proposed rule (83 FR 41922), we assumed that ACOs dropping
out of the program may continue to produce residual savings in certain
years following their exit from the program because of efficient
practices put in place that may continue even after participation in
the program ends. Therefore, while we estimate that ACOs electing the
extension would produce additional savings on claims exceeding the cost
of the anticipated $170 million in shared savings payments for the
extension period, we note that lesser residual claims savings would
also be expected for the baseline where such ACOs are not allowed to
extend their participation in the program in the first 6 months of 2019
and therefore would not earn shared savings payments for that period.
However, when considering the residual difference in savings on claims
attributable to the 6-month extension period over the 12 months
following the end of the extension we estimate that the $170 million in
shared savings payments for the extension period would be fully offset
by the effect of the extension on preserving a higher savings
trajectory than the up to 200 ACOs that are expected to elect the
extension would have exhibited absent the extension.
Lastly, we note that the modifications to the Shared Savings
Program finalized in this rule that rely on the authority of section
1899(i)(3) of the Act, including most notably the methodology for
determining the financial performance for the 6-month performance year
from January 1, 2019, through June 30, 2019, for ACOs that voluntarily
elect the extension, based on the entire 12-month CY 2019 and pro-
rating the amount of any shared savings or shared losses to reflect the
ACO's participation during a 6-month period, comply with requirements
of section 1899(i)(3)(B). The considerations we described in the August
2018 proposed rule (83 FR 41851) (as well as those considerations
discussed in section V.B.1. of this final rule) were relevant in making
this determination. Specifically, we do not believe that the
methodology for determining the financial performance of ACOs in a 6-
month performance year from January 1, 2019, through June 30, 2019,
would result in an increase in spending beyond the expenditures that
would otherwise occur under the statutory payment methodology
prescribed in section 1899(d) of the Act.
Finalizing the voluntary 6-month extension for ACOs whose agreement
periods expire on December 31, 2018, supports continued participation
by these ACOs, and therefore also allows

[[Page 60060]]

for lower growth in Medicare FFS expenditures based on projected
participation trends. The extension is estimated to produce net savings
over the baseline non-extension scenario when considering the residual
benefit to savings on claims for Parts A and B services over a period
of one or more years after the end of the 6-month extension period.
Further, we believe the approach we are finalizing for determining the
performance of ACOs for the 6-month performance year from January 1,
2019, through June 30, 2019, would continue to lead to improvement in
the quality of care furnished to Medicare FFS beneficiaries. As
described in section V.B.1.c.4. of this final rule, the approach to
measuring ACO quality performance for the 6-month performance year from
January 1, 2019, through June 30, 2019, based on quality data reported
for CY 2019, would maintain accountability for the quality of care ACOs
provide to their assigned beneficiaries. Participating ACOs would have
an incentive to perform well on the quality measures in order to
maximize any shared savings they may receive and minimize any shared
losses they must pay in tracks where the loss sharing rate is
determined based on the ACO's quality performance.
The anticipated forthcoming final rule will provide a detailed
estimate of the impact of all other changes that may be finalized from
the August 2018 proposed rule.

G. Alternatives Considered

This final rule contains a range of policies, including some
provisions related to specific statutory provisions. The preceding
preamble provides descriptions of the statutory provisions that are
addressed, identifies those policies when discretion has been
exercised, presents rationale for our proposed policies and, where
relevant, alternatives that were considered. For purposes of the
payment impact on PFS services of the policies contained in this final
rule, we presented the estimated impact on total allowed charges by
specialty. The alternatives we considered, as discussed in the
preceding preamble sections, would result in different payment rates,
and therefore, result in different estimates than those shown in Table
94 (CY 2019 PFS Estimated Impact on Total Allowed Charges by
Specialty).
1. E/M Coding and Payment Alternatives Considered
For the CY 2019 PFS proposed rule, we considered a number of other
options for simplifying coding and payment for E/M services to align
with the proposed reduction in documentation requirements and better
account for the resources associated with inherent complexity, visit
complexity, and visits furnished on the same day as a 0-day global
procedure. For example, as we noted in the proposed rule, we considered
establishing single payment rates for new and established patients for
combined E/M visit levels 2 through 4, as opposed to combined E/M visit
levels 2 through 5, as we proposed. We considered the potential impacts
of making this change in isolation.

Table 100--Unadjusted Estimated Specialty Impacts of Single PFS Rate for
Office/Outpatient E/M Levels 2 Through 4
[As displayed in the CY 2019 PFS proposed rule]
------------------------------------------------------------------------
Allowed
Specialty charges Impact
(millions) (percent)
------------------------------------------------------------------------
Podiatry................................ $2,022 10
Dermatology............................. 3,525 6
Hand Surgery............................ 202 5
Oral/Maxillofacial Surgery.............. 57 4
Otolaryngology.......................... 1,220 4
Cardiology.............................. 6,723 -3
Hematology/Oncology..................... 1,813 -3
Neurology............................... 1,565 -3
Rheumatology............................ 559 -6
Endocrinology........................... 482 -8
------------------------------------------------------------------------
Note: All other specialty level impacts were within +/-3%.

Table 100 shows the specialties that would experience the greatest
increase or decrease by establishing single payment rates for E/M visit
levels 2 through 4, while maintaining the value of the level 1 and the
level 5 E/M visits. We note that this alternative is similar to the
policy we are finalizing for CY 2021. However, we are also finalizing
the inherent visit complexity add-on codes that will likely result in
mitigating some of the more significant estimated specialty-level
impacts of establishing a single rate for the level 2-4 visits.
While considering whether to finalize a single payment rate for new
and established office/outpatient E/M visit levels 2-5, we explored a
number of alternative scenarios based on commenters' varied responses
to aspects of our proposal. For example, we considered the potential
impacts on finalizing all elements of the proposal except for the MPPR
and the single PE/hr value across the office/outpatient E/M code set.

[[Page 60061]]

Table 101--Specialty Level Impacts of Finalizing as Proposed With the Exception of the MPPR and PE/hr
Adjustments
----------------------------------------------------------------------------------------------------------------
Impact of work Impact of PE Impact of MP
Specialty Allowed RVU changes RVU changes RVU changes Combined
charges (mil) (%) (%) (%) impact (%)
(A) (B) (C) (D) (E) (F)
----------------------------------------------------------------------------------------------------------------
Allergy/Immunology.............. $239 1 1 0 2
Anesthesiology.................. 1,981 0 0 0 -1
Audiologist..................... 68 0 1 0 1
Cardiac Surgery................. 294 -1 -1 0 -2
Cardiology...................... 6,618 0 -1 0 -1
Chiropractor.................... 754 0 0 0 -1
Clinical Psychologist........... 776 0 2 0 1
Clinical Social Worker.......... 728 -1 2 0 2
Colon And Rectal Surgery........ 166 0 1 0 2
Critical Care................... 342 -1 -1 0 -2
Dermatology..................... 3,486 3 4 0 7
Diagnostic Testing Facility..... 733 0 -4 0 -5
Emergency Medicine.............. 3,121 -1 0 0 -1
Endocrinology................... 482 0 -1 0 -1
Family Practice................. 6,208 0 0 0 0
Gastroenterology................ 1,757 -1 0 0 -1
General Practice................ 429 0 0 0 0
General Surgery................. 2,093 0 0 0 1
Geriatrics...................... 197 -2 -1 0 -4
Hand Surgery.................... 214 3 2 0 5
Hematology/Oncology............. 1,741 -1 -1 0 -2
Independent Laboratory.......... 646 0 4 0 3
Infectious Disease.............. 649 -1 -1 0 -2
Internal Medicine............... 10,767 -1 0 0 -1
Interventional Pain Mgmt........ 868 2 3 0 5
Interventional Radiology........ 386 0 -1 0 -1
Multispecialty Clinic/Other Phys 149 -1 -1 0 -2
Nephrology...................... 2,190 -2 -1 0 -3
Neurology....................... 1,529 -1 -1 0 -2
Neurosurgery.................... 804 0 0 0 0
Nuclear Medicine................ 50 -1 -1 0 -2
Nurse Anes/Anes Asst............ 1,242 -1 0 0 -1
Nurse Practitioner.............. 4,065 1 1 0 1
Obstetrics/Gynecology........... 638 3 3 0 6
Ophthalmology................... 5,448 0 -1 0 -1
Optometry....................... 1,309 1 0 0 1
Oral/Maxillofacial Surgery...... 68 1 1 0 2
Orthopedic Surgery.............. 3,743 1 2 0 3
Other........................... 31 -1 3 0 3
Otolarngology................... 1,210 4 4 0 8
Pathology....................... 1,165 0 -1 0 -1
Pediatrics...................... 61 -1 0 0 -1
Physical Medicine............... 1,107 -1 0 0 -1
Physical/Occupational Therapy... 3,950 0 -2 0 -2
Physician Assistant............. 2,457 1 2 0 3
Plastic Surgery................. 377 1 1 0 3
Podiatry........................ 1,974 0 -3 0 -4
Portable X-Ray Supplier......... 99 0 0 0 0
Psychiatry...................... 1,187 0 1 0 1
Pulmonary Disease............... 1,715 -2 -2 0 -4
Radiation Oncology And Radiation 1,766 -1 -1 0 -2
Therapy Centers................
Radiology....................... 4,911 0 -1 0 -1
Rheumatology.................... 541 0 0 0 0
Thoracic Surgery................ 358 -1 -1 0 -2
Urology......................... 1,738 3 3 0 6
Vascular Surgery................ 1,148 0 -2 0 -1
-------------------------------------------------------------------------------
Total....................... 92,771 0 0 0 0
----------------------------------------------------------------------------------------------------------------

We also explored an alternative of finalizing all elements of the
proposal except for separate coding for podiatric E/M visits and the
application of a single PE/hr across the office/outpatient E/M codes.

[[Page 60062]]

Table 102--Specialty Level Impacts of Finalizing as Proposed With the Exception of the Separate Podiatric G
codes and PE/hr Adjustments
----------------------------------------------------------------------------------------------------------------
Impact of Impact of PE Impact of MP
Specialty Allowed work RVU RVU changes RVU changes Combined
charges (mil) changes (%) (%) (%) impact (%)
(A) (B) (C) (D) (E) (F)
----------------------------------------------------------------------------------------------------------------
Allergy/Immunology.............. $239 1 1 0 2
Anesthesiology.................. 1,981 0 0 0 0
Audiologist..................... 68 0 2 0 1
Cardiac Surgery................. 294 -1 -1 0 -2
Cardiology...................... 6,618 0 -1 0 -1
Chiropractor.................... 754 0 1 0 0
Clinical Psychologist........... 776 0 2 0 1
Clinical Social Worker.......... 728 0 2 0 2
Colon And Rectal Surgery........ 166 0 0 0 0
Critical Care................... 342 -1 -1 0 -2
Dermatology..................... 3,486 1 1 0 2
Diagnostic Testing Facility..... 733 0 -4 0 -4
Emergency Medicine.............. 3,121 0 0 0 -1
Endocrinology................... 482 0 -1 0 -1
Family Practice................. 6,208 0 0 0 0
Gastroenterology................ 1,757 -1 0 0 -1
General Practice................ 429 0 0 0 0
General Surgery................. 2,093 0 0 0 0
Geriatrics...................... 197 -2 -1 0 -3
Hand Surgery.................... 214 1 1 0 2
Hematology/Oncology............. 1,741 -1 -1 0 -2
Independent Laboratory.......... 646 0 4 0 4
Infectious Disease.............. 649 -1 -1 0 -2
Internal Medicine............... 10,767 -1 0 0 -1
Interventional Pain Mgmt........ 868 2 2 0 4
Interventional Radiology........ 386 1 -1 0 0
Multispecialty Clinic/Other Phys 149 -1 -1 0 -2
Nephrology...................... 2,190 -1 -1 0 -2
Neurology....................... 1,529 -1 -1 0 -2
Neurosurgery.................... 804 0 0 0 0
Nuclear Medicine................ 50 -1 -1 0 -2
Nurse Anes/Anes Asst............ 1,242 0 0 0 0
Nurse Practitioner.............. 4,065 0 1 0 1
Obstetrics/Gynecology........... 638 3 2 0 5
Ophthalmology................... 5,448 0 -1 0 -1
Optometry....................... 1,309 1 0 0 1
Oral/Maxillofacial Surgery...... 68 1 1 0 2
Orthopedic Surgery.............. 3,743 1 1 0 1
Other........................... 31 -1 4 0 3
Otolarngology................... 1,210 2 2 0 4
Pathology....................... 1,165 0 -1 0 -1
Pediatrics...................... 61 -1 0 0 -1
Physical Medicine............... 1,107 -1 0 0 -1
Physical/Occupational Therapy... 3,950 0 -1 0 -1
Physician Assistant............. 2,457 0 1 0 1
Plastic Surgery................. 377 1 1 0 2
Podiatry........................ 1,974 5 5 0 10
Portable X-Ray Supplier......... 99 0 0 0 1
Psychiatry...................... 1,187 0 1 0 1
Pulmonary Disease............... 1,715 -2 -1 0 -4
Radiation Oncology And Radiation 1,766 0 0 0 -1
Therapy Centers................
Radiology....................... 4,911 0 -1 0 0
Rheumatology.................... 541 -1 -1 0 -2
Thoracic Surgery................ 358 -1 -1 0 -2
Urology......................... 1,738 2 3 0 5
Vascular Surgery................ 1,148 0 -1 0 -1
-------------------------------------------------------------------------------
Total....................... 92,771 0 0 0 0
----------------------------------------------------------------------------------------------------------------

We considered alternatives that included finalizing all elements of
the proposal, except for the PE/hr change and separate coding for
podiatric E/M visits and establishing a single payment rate for office/
outpatient new and established E/M visit levels 2 through 4, rather
than a single payment rate for office/outpatient E/M levels 2 through 5
as proposed. Table 103 illustrates the specialty level impacts of this
alternative.

[[Page 60063]]

Table 103--Specialty Level Impact of Finalizing Single PFS Rates for Office/Outpatient E/M Levels 2 Through 4
and Other Proposed Elements With the Exception of PE/hr Adjustment and the G-Codes for Podiatric Visits
----------------------------------------------------------------------------------------------------------------
Impact of Impact of PE Impact of MP
Specialty Allowed work RVU RVU changes RVU changes Combined
charges (mil) changes (%) (%) (%) impact (%)
(A) (B) (C) (D) (E) (F)
----------------------------------------------------------------------------------------------------------------
Allergy/Immunology.............. $239 1 1 0 1
Anesthesiology.................. 1,981 -1 0 0 -1
Audiologist..................... 68 -1 1 0 1
Cardiac Surgery................. 294 -1 -1 0 -1
Cardiology...................... 6,618 0 -1 0 -1
Chiropractor.................... 754 -1 0 0 -1
Clinical Psychologist........... 776 -1 1 0 1
Clinical Social Worker.......... 728 -1 2 0 1
Colon And Rectal Surgery........ 166 -1 0 0 -1
Critical Care................... 342 -1 -1 0 -2
Dermatology..................... 3,486 0 0 0 0
Diagnostic Testing Facility..... 733 0 -4 0 -4
Emergency Medicine.............. 3,121 -1 0 0 -1
Endocrinology................... 482 0 -1 0 -1
Family Practice................. 6,208 1 1 0 2
Gastroenterology................ 1,757 -1 0 0 -2
General Practice................ 429 -1 0 0 -1
General Surgery................. 2,093 0 0 0 0
Geriatrics...................... 197 0 0 0 -1
Hand Surgery.................... 214 0 0 0 0
Hematology/Oncology............. 1,741 1 0 0 1
Independent Laboratory.......... 646 0 4 0 4
Infectious Disease.............. 649 -1 -1 0 -2
Internal Medicine............... 10,767 0 0 0 1
Interventional Pain Mgmt........ 868 1 2 0 3
Interventional Radiology........ 386 0 -1 0 -1
Multispecialty Clinic/Other Phys 149 -1 -1 0 -2
Nephrology...................... 2,190 -2 -1 0 -2
Neurology....................... 1,529 0 0 0 0
Neurosurgery.................... 804 -1 0 0 -1
Nuclear Medicine................ 50 -1 -1 0 -2
Nurse Anes/Anes Asst............ 1,242 -1 0 0 -1
Nurse Practitioner.............. 4,065 2 1 0 3
Obstetrics/Gynecology........... 638 2 2 0 4
Ophthalmology................... 5,448 -1 -1 0 -2
Optometry....................... 1,309 0 -1 0 0
Oral/Maxillofacial Surgery...... 68 0 1 0 1
Orthopedic Surgery.............. 3,743 0 0 0 0
Other........................... 31 -1 4 0 3
Otolarngology................... 1,210 1 1 0 2
Pathology....................... 1,165 -1 -1 0 -2
Pediatrics...................... 61 1 0 0 1
Physical Medicine............... 1,107 -1 0 0 -2
Physical/Occupational Therapy... 3,950 -1 -1 0 -2
Physician Assistant............. 2,457 1 1 0 2
Plastic Surgery................. 377 0 0 0 1
Podiatry........................ 1,974 3 4 0 8
Portable X-Ray Supplier......... 99 0 1 0 1
Psychiatry...................... 1,187 0 1 0 1
Pulmonary Disease............... 1,715 -2 -1 0 -3
Radiation Oncology And Radiation 1,766 0 0 0 -1
Therapy Centers................
Radiology....................... 4,911 0 -1 0 -1
Rheumatology.................... 541 -1 -1 0 -2
Thoracic Surgery................ 358 -1 0 0 -1
Urology......................... 1,738 1 2 0 4
Vascular Surgery................ 1,148 0 -1 0 -1
-------------------------------------------------------------------------------
Total....................... 92,771 0 0 0 0
----------------------------------------------------------------------------------------------------------------

In this scenario, specialties that furnish a large volume of
standalone office/outpatient E/M visits in conjunction with minor
procedures see decreases in overall impacts, while specialties who tend
to only bill E/M office/outpatient visits see minor increases and in
many instances, the application of the MPPR adjustment is

[[Page 60064]]

not enough to overcome the negative impacts of the single payment rate
on specialties that bill a higher volume of level 4 visits relative to
their overall allowed services.
We also modeled the specialty level impacts associated with
finalizing all elements of the proposal with the exception of the PE/hr
adjustment and the MPPR, but establishing a single payment rate for
office/outpatient new and established E/M visit levels 2-4, rather than
a single payment rate for office/outpatient E/M levels 2-5 as proposed.
Table 104 illustrates the specialty level impacts for this alternative.

Table 104--Specialty Level Impact of Finalizing Single PFS Rates for Office/Outpatient E/M Levels 2 Through 4
and Other Elements as Proposed
----------------------------------------------------------------------------------------------------------------
Impact of work Impact of PE Impact of MP
Specialty Allowed RVU changes RVU changes RVU changes Combined
charges (mil) (%) (%) (%) impact (%)
(A) (B) (C) (D) (E) (F)
----------------------------------------------------------------------------------------------------------------
Allergy/Immunology.............. $239 0 0 0 1
Anesthesiology.................. 1,981 -1 0 0 -2
Audiologist..................... 68 -1 1 0 0
Cardiac Surgery................. 294 -1 -1 0 -2
Cardiology...................... 6,618 -1 -1 0 -2
Chiropractor.................... 754 -1 -1 0 -2
Clinical Psychologist........... 776 -1 1 0 0
Clinical Social Worker.......... 728 -1 2 0 1
Colon And Rectal Surgery........ 166 0 1 0 1
Critical Care................... 342 -2 -1 0 -3
Dermatology..................... 3,486 2 3 0 5
Diagnostic Testing Facility..... 733 0 -5 0 -5
Emergency Medicine.............. 3,121 -1 0 0 -2
Endocrinology................... 482 -1 -1 0 -1
Family Practice................. 6,208 1 1 0 3
Gastroenterology................ 1,757 -2 0 0 -2
General Practice................ 429 2 1 0 4
General Surgery................. 2,093 0 0 0 0
Geriatrics...................... 197 -1 0 0 -1
Hand Surgery.................... 214 1 2 0 3
Hematology/Oncology............. 1,741 0 0 0 0
Independent Laboratory.......... 646 -1 3 0 3
Infectious Disease.............. 649 -1 0 0 -1
Internal Medicine............... 10,767 0 0 0 0
Interventional Pain Mgmt........ 868 1 2 0 3
Interventional Radiology........ 386 0 -1 0 -1
Multispecialty Clinic/Other Phys 149 -1 -1 0 -2
Nephrology...................... 2,190 -1 0 0 -1
Neurology....................... 1,529 0 0 0 -1
Neurosurgery.................... 804 -1 0 0 -1
Nuclear Medicine................ 50 -1 -1 0 -2
Nurse Anes/Anes Asst............ 1,242 -1 0 0 -2
Nurse Practitioner.............. 4,065 2 1 0 3
Obstetrics/Gynecology........... 638 2 2 0 5
Ophthalmology................... 5,448 -1 -1 0 -2
Optometry....................... 1,309 0 -1 0 -1
Oral/Maxillofacial Surgery...... 68 1 1 0 1
Orthopedic Surgery.............. 3,743 0 1 0 1
Other........................... 31 -1 3 0 2
Otolarngology................... 1,210 3 3 0 6
Pathology....................... 1,165 -1 -1 0 -2
Pediatrics...................... 61 1 0 0 1
Physical Medicine............... 1,107 -1 0 0 -2
Physical/Occupational Therapy... 3,950 -1 -2 0 -3
Physician Assistant............. 2,457 2 2 0 4
Plastic Surgery................. 377 0 1 0 1
Podiatry........................ 1,974 -1 -4 0 -5
Portable X-Ray Supplier......... 99 0 0 0 0
Psychiatry...................... 1,187 3 2 0 5
Pulmonary Disease............... 1,715 -1 -1 0 -1
Radiation Oncology And Radiation 1,766 0 -1 0 -1
Therapy Centers................
Radiology....................... 4,911 -1 -1 0 -2
Rheumatology.................... 541 0 0 0 0
Thoracic Surgery................ 358 -1 -1 0 -2
Urology......................... 1,738 2 3 0 5
Vascular Surgery................ 1,148 0 -2 0 -2
-------------------------------------------------------------------------------
Total....................... 92,771 0 0 0 0
----------------------------------------------------------------------------------------------------------------

[[Page 60065]]

2. E/M Documentation Alternatives Considered
We considered several alternatives to our final policies on
documentation of E/M office/outpatient visits. Under all of these
alternatives, we would finalize the documentation proposals that are
not associated with coding and payment changes (the documentation
proposals for home visits and avoiding redundant data recording that we
are finalizing for January 1, 2019 as proposed).
Regarding the rest of the documentation policies, one alternative
we considered was to maintain all five current E/M office/outpatient
visit levels and eliminate additional documentation requirements. Under
this option, there would be no minimum documentation standard because
payment rates for multiple code levels would not be combined, but we
could still have allowed choice in documentation methodology (current
framework, MDM or time). Overall payments would likely change due to
increased ability to use different key components to reach different
code levels relative to the status quo. There would be no new add-on
codes for primary care, other non-procedural specialty care or
prolonged services, since the current code set would continue to
differentiate levels of complexity. We estimate that this alternative
would have reduced the documentation burden for office/outpatient
visits by approximately 5 percent or 0.32 minutes per impacted visit.
However, this alternative could result in significant and unpredictable
redistributive effects as there would be a financial incentive to code
to the highest possible visit level. Given that possibility, we chose
not to finalize this alternative.
Another alternative was our proposed policies, which in the
proposed rule we estimated would have reduced administrative burden by
approximately 1.6 minutes per impacted visit. A large part of this time
savings was attributed to the associated application of the minimum
level 2 visit documentation standard to most visits (levels 2 through
5). We did not finalize this proposal because we were persuaded by
public comments (detailed elsewhere in this final rule), indicating
that Medicare should continue to recognize distinctions in visit
complexity among the current level 2 through 5 visits.
3. Modernizing Medicare Physician Payment by Recognizing Communication
Technology-Based Services Alternatives Considered
We considered not finalizing our proposal in the CY 2019 PFS
proposed rule to recognize a discrete set of services that are defined
by and inherently involve the use of communication technology. If we
had not finalized making separate coding and payment for HCPCS codes
G2010 ((Remote evaluation of recorded video and/or images submitted by
an established patient (e.g., store and forward), including
interpretation with follow-up with the patient within 24 business
hours, not originating from a related E/M service provided within the
previous 7 days nor leading to an E/M service or procedure within the
next 24 hours or soonest available appointment) and G2012 ((Brief
communication technology-based service, e.g. virtual check-in, by a
physician or other qualified health care professional who can report
evaluation and management services, provided to an established patient,
not originating from a related E/M service provided within the previous
7 days nor leading to an E/M service or procedure within the next 24
hours or soonest available appointment; 5-10 minutes of medical
discussion) for CY 2019, we estimate that there would have been a 0.2
percent increase to the CF, based on our estimate that usage of these
services will result in fewer than 1 million visits in the first year
but will eventually result in more than 19 million visits per year,
ultimately increasing payments under the PFS by about 0.2 percent.
4. Alternatives Considered for the AUC Program
For the purposes of estimating potential alternatives to the
proposals in the CY 2019 PFS proposed rule for the AUC program, we
considered the alternative scenarios below.
a. Consultation With More Than One Qualified CDSM
We considered an alternative scenario that would result in ordering
professionals or auxiliary staff consulting more than one qualified
CDSM prior to ordering advanced diagnostic imaging. In this scenario,
we assumed a goal of decreasing the frequency that a ``not applicable''
consultation result would be reported on Medicare claims. One outcome
of reducing ``not applicable'' responses is the potential to improve
the quality and quantity of claims-based data available for calculating
outlier ordering professionals. In future rulemaking the agency will
establish the methodology to identifying outlier ordering
professionals. Reducing ``not applicable'' responses will increase
responses for adherence or non-adherence thereby increasing the total
number of responses that can be used to calculate outlier ordering
professionals. Additionally, according to the Medicare Imaging
Demonstration Evaluation Report,\1\ clinicians were conceptually
interested in learning about how to improve ordering patterns. Ordering
professionals receiving ``not applicable'' responses for some of their
orders may not be able to achieve desired learning directly through the
CDSM and may have to seek information elsewhere. Therefore reducing the
number of ``not applicable'' responses may allow ordering professionals
to achieve more of their learning within the CDSM.
In this assumption, the ordering professional or auxiliary
personnel would consult their primary, qualified CDSM to find that such
AUC were not available. For example, a consultation using CDSM 1 for a
patient with unspecified abdominal pain results in no specified
applicable AUC being available, and therefore, provides a ``not
applicable'' result. In this clinical scenario, we know that specified
applicable AUC are available (https://acsearch.acr.org/docs/69467/Narrative/) in qualified CDSM 2 and that CDSM 2 is available free of
charge. Second, we assumed that additional requirements to reduce ``not
applicable'' consultation outcomes, through tighter stipulations on AUC
consultation, would change behavior in that a second consultation would
occur (qualified CDSM 2). For example, we know that all CDSMs are
required, consistent with Sec. 414.94(g)(1)(iii) of our regulations to
make available, at a minimum, specified applicable AUC that reasonably
address common and important clinical scenarios within all priority
clinical areas. Therefore, there may be clinical scenarios (for
example, unspecified abdominal pain) outside of priority clinical areas
that are not addressed within all qualified CDSMs. However, tighter
requirements on AUC consultation--to consult a second CDSM when a ``not
applicable'' response is the result of the first consultation in
specific clinical scenarios--would reduce ``not applicable'' reporting
on Medicare claims and would motivate ordering professionals to access
a secondary CDSM that is qualified and available free of charge. CMS
did not propose to require any ordering professional to

[[Page 60066]]

perform any additional AUC consultation if the initial consultation
yields a result of ``not applicable.'' Rather, the ordering
professional would have completely satisfied their AUC consultation
requirement under Sec. 414.94(j) with the first AUC consultation,
regardless of the determination of the qualified CDSM.
Based on these assumptions, we identified examples of the advanced
diagnostic imaging services that are outside the priority clinical
areas yet have AUC available for a specific clinical scenario in a
qualified, free CDSM. We focused our analysis on abdominal pain (any
locations and flank pain). In addition, we identified the top five
advanced diagnostic imaging services from data derived from the CCW's
2014 Part B non-institutional claim line file, which includes services
covered by the Part B benefit that were furnished during calendar year
2014. These data are available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/data.html.
We estimated the burden of consulting a second, free CDSM to reduce
the frequency of ``not applicable'' responses, which we did not
propose. We did this by calculating the number of advanced diagnostic
imaging services for unspecified abdominal pain based on 2014 claims
data (Computed tomography of abdomen & pelvis with contrast--CPT
74177--299,644 services; Computed tomography of abdomen & pelvis with
and without contrast--CPT 74176--233,088 services; Computed tomography
of abdomen and pelvis; without contrast material in one or both body
regions, followed by contrast material(s) and further sections in one
or both body regions--CPT 74178--36,992 services; Diagnostic nuclear
medicine procedures on the gastrointestinal system with pharmacologic
intervention--CPT 78227--20,997 services; Diagnostic nuclear medicine
procedures on the gastrointestinal system--CPT 78226-10,713 services).
According to the Medicare Imaging Demonstration Evaluation Report,\1\
clinicians were conceptually interested in learning about how to
improve ordering patterns, and in the context of clinical practice,
most clinician focus group participants noted that they expected that a
clinical decision support tool would provide more detailed feedback
that would help clinicians reduce the number of inappropriately rated
orders. Unfortunately, data compiled \73\ as of 2002 suggested that
appropriateness criteria could not be applied to 41-percent of MRI
imaging requests. These gaps in appropriateness criteria often prompt
local providers to augment the criteria produced by professional
societies with their own decisions on appropriateness. One study \74\
has shown that clinicians use appropriateness criteria far less often
than other resources, such as specialist consults and UpToDate (Wolters
Kluwer Health), to guide the management of their patients. In order to
meet the expressed needs of ordering professionals, and direct ordering
behaviors towards qualified CDSMs with specific applicable AUC, we
considered pursuing tighter requirements in the context of the
following impact estimate.
---------------------------------------------------------------------------

\73\ Levy, G et al. 2006. Nonradiologist utilization of American
College of Radiology appropriateness criteria in apreauthorization
center for MRI requests: Applicability and effects. AJR Am J
Roentgenol, 187(4), 855-858. doi: 10.2214/AJR.05.1055.
\74\ Bautista, AB et al. 2009. Do clinicians use the American
College of Radiology appropriateness criteria in the management of
their patients? AJR Am J Roentgenol, 192(6), 1581-1585. doi:
10.2214/AJR.08.1622.
---------------------------------------------------------------------------

If we assume that 50 percent of these 601,434 total services
required a second consultation because the specified applicable AUC
were available in CDSM 1 then this estimate would be the time and
effort for a 2-minute repeat consultation with another qualified CDSM
available free of charge for 300,717 services annually (601,434
services x 50 percent). If 90 percent of those consultations (300,717
services x 90 percent x 0.033 hr/service) for 8,931.285 total hours
were performed by a medical assistant (occupation code 31-9092) at a
rate of $32.30/hour for a total of $288,480.50 and 10 percent of
consultations (300,717 services x 10 percent x 0.033 hr/service) for
992.376 total hours were performed by the ordering professional at a
rate of $200.54/hour for a total of $199,011.08 then annually the
burden estimate would be 9,923.661 total hours (8,931.285 hours +
992.376 hours) and $487,491.58 ($288,480.50 + $199,011.08) to perform
the second consultations. This analysis was limited to abdominal pain
because that is one example of a clinical scenario that falls outside
of the priority clinical areas. In the proposed rule we did not propose
tighter requirements on the frequency to which ordering professionals
or applicable staff would be required to consult at this time this was
due to the agency's efforts to minimize burden whereas a second
consultation would result in added time and cost to the ordering
professional.
b. Significant Hardship Application Process
To illustrate the consideration that a self-attestation of a
significant hardship exception is a less burdensome approach, we
compared this to the alternative consideration of requiring a
significant hardship exception application process to review and
approve applicants in near real-time. We recognize that there are some
benefits to a significant hardship exception application that could not
be directly quantified. For instance, some ordering professionals may
gain confidence knowing that they have documentation confirming that a
significant hardship exception application was submitted and/or
received by CMS. Those same ordering professionals and others may
appreciate a process that includes receipt of a determination from CMS
as to the acceptance of their application for significant hardship
exception. Finally some furnishing professionals and facilities that
provide advanced diagnostic imaging services as a result of orders
placed by ordering professionals could have reassurance knowing that
such ordering professionals have a significant hardship exception
granted by CMS and confirmed for 1 year.
As a basis for comparison of the significant hardship exception
application to self-attestation, we estimate that such an application
would be similar to the existing application (CMS-10621, OCN 0938-1314)
to request a reweighting to zero for the advancing care information
performance category (renamed the promoting interoperability
performance category) due to significant hardship. This is a short
online form that requires identifying which type of hardship applies,
and a description of how the circumstances impair the ability to submit
advancing care information data, as well as some proof of
circumstances. The estimate for the $44.59 mean hourly wage and 100-
percent fringe benefits of a computer system analyst (BLS #15-1121) to
submit this application is 0.5 hours. Given that we would expect 6,699
AUC hardship applications per year, the annual total burden hours are
estimated to be 3349.50 hours (6,699 respondents x 0.5 burden hours per
respondent). The estimated total annual burden is $298,708.41 (3349.50
hours x $89.18 per hour). Based in part on the cost and burden
estimates, we did not propose the use of a significant hardship
exception application.

[[Page 60067]]

5. Alternatives Considered for the Quality Payment Program
For purposes of the payment impact on the Quality Payment Program,
we view the performance threshold and the additional performance
threshold, as the critical factors affecting the distribution of
payment adjustments. We ran two separate models with performance
thresholds of 25 and 35 respectively (as an alternative to the
finalized performance threshold of 30) to estimate the impact of a
moderate and aggressive increase in the performance threshold. A lower
performance threshold would be a more gradual transition and could
potentially allow more clinicians to meet or exceed the performance
threshold. The lower performance threshold would lower the amount of
budget neutral dollars to redistribute and increase the number of
clinicians with a positive payment adjustment but the scaling factor
would be lower. In contrast, a more aggressive increase would likely
lead to higher positive payment adjustments for clinicians that exceed
the performance threshold because the budget neutral pool would be
redistributed among fewer clinicians. We ran each of these models using
the finalized additional performance threshold of 75. In the model with
a performance threshold of 25, we estimate that $271 million would be
redistributed through budget neutrality. There would be a maximum
payment adjustment of 4.5 percent after considering the MIPS payment
adjustment and the additional MIPS payment adjustment for exceptional
performance. In addition, 7.2 percent of MIPS eligible clinicians would
receive a negative payment adjustment among those that submit data. In
the model with a performance threshold of 35, we estimate that $349
million would be redistributed through budget neutrality, and that
there would be a maximum payment adjustment of 4.9 percent after
considering the MIPS payment adjustment and the additional MIPS payment
adjustment for exceptional performance. In addition, 10.5 percent of
MIPS eligible clinicians would receive a negative payment adjustment
among those that submit data. We finalized a performance threshold of
30 because we believe increasing the performance threshold to 30 points
was not unreasonable or too steep, but rather a moderate step that
encourages clinicians to gain experience with all MIPS performance
categories. We refer readers to section III.I.3.j.(2) of this final
rule for additional rationale on the selection of performance
threshold.
To evaluate the impact of modifying the additional performance
threshold, we ran two models with additional performance thresholds of
70 and 80 as an alternative to the finalized 75 points. We ran each of
these models using a performance threshold of 30. The benefit of the
model with the additional performance threshold of 70 would maintain
the additional performance threshold that was in years 2 and 3. In the
model with the additional performance threshold of 70, we estimate that
$310 million would be redistributed through budget neutrality, and
there would be a maximum payment adjustment of 3.9 percent after
considering the MIPS payment adjustment and the additional MIPS payment
adjustment for exceptional performance. In addition, 8.8 percent of
MIPS eligible clinicians would receive a negative payment adjustment
among those that submit data. In the model with an additional
performance threshold of 80, for which the benefit was to assess the
impact of the proposed additional performance threshold in the 2019 PFS
proposed rule, we estimate that $310 million would be redistributed
through budget neutrality, and that there would be a maximum payment
adjustment of 6.1 percent after considering the MIPS payment adjustment
and the additional MIPS payment adjustment for exceptional performance
among those that submit data. Also, that 8.8 percent of MIPS eligible
clinicians will receive a negative payment adjustment. We finalized the
additional performance threshold at 75 points, which is halfway between
our proposal of 80 and the CY 2018 MIPS performance period additional
performance threshold at 70 because we believe raising the additional
performance threshold, but for less than the original amount proposed,
would incentivize continued improved performance while accounting for
policy changes in the third year of the program. We refer readers to
section III.I.3.j.(3) of this final rule for additional rationale on
the selection of additional performance threshold.
To examine the impact of changes to the low-volume threshold on the
number of MIPS eligible clinicians, we ran estimates for three
different low-volume threshold criteria. As we discuss in section
III.I.3.c of this final rule, we analyzed the impact of alternate low-
volume thresholds because the low-volume threshold can affect the
number of MIPS eligible clinicians and some public commenters were
concerned about the associated impacts of the exclusions on the MIPS
payment adjustments. When we set the third low volume threshold at 100
as an alternative to 200 covered professional services, we estimate
that 32,828 clinicians would elect to opt-in for a total population of
802,915. When we apply the opt-in policy without adding the third
finalized low-volume criterion at 200 covered professional services, we
estimate that 12,242 clinicians would elect to opt-in for a total
population of 782,329. When we lower the low-volume threshold criteria
to $30,000 or fewer allowed charges for covered professional services;
100 or fewer Part B-enrolled individuals; and 100 or fewer furnished
covered professional services to Medicare Part B-enrolled
beneficiaries, we estimate a total of 871,238 MIPS eligible clinicians.
To assess the impact of the number of MIPS eligible clinicians on
payment adjustments, we ran a model with the lowest low-volume
threshold and, therefore, highest number of MIPS eligible clinicians
(871,238). We estimate that $440 million would be redistributed through
budget neutrality. There would be a maximum payment adjustment of 5.0
percent after considering the MIPS payment adjustment and the
additional MIPS payment adjustment for exceptional performance. In
addition, 9.7 percent of MIPS eligible clinicians would receive a
negative payment adjustment among those that submit data. These
alternative low-volume thresholds were not selected because we did not
observe a meaningful difference on the maximum payment adjustment from
the finalized low-volume threshold in this final rule. As we stated in
section III.I.3.c.(4) of this final rule, we will continue to strike a
balance between ensuring sufficient participation in MIPS while also
addressing the needs of small practices that may find it difficult to
meet the program requirements. We refer readers to section
III.I.3.c.(4) of this final rule for additional rationale on the
selection of the low-volume threshold.

H. Impact on Beneficiaries

There are a number of changes in this final rule that will have an
effect on beneficiaries. In general, we believe that many of these
changes, including those intended to improve accuracy in payment
through regular updates to the inputs used to calculate payments under
the PFS, will have a positive impact and improve the quality and value
of care provided to Medicare providers and beneficiaries.

[[Page 60068]]

I. Burden Reduction Estimates

1. Evaluation and Management Documentation
All health care practitioners, as part of their routine record
keeping activities, create and maintain documentation in the patient
medical record for clinical and payment purposes. It is standard
industry practice that when healthcare practitioners bill insurers,
payers and health plans, such as Medicare, state plans under Title XIX,
and commercial or other third party payers, for office and outpatient
E/M services, that health care practitioners report the services using
the common coding framework and definitions developed and maintained by
the AMA CPT Editorial Panel. The 1995/1997 E/M services documentation
guidelines provide guidance to medical practitioners regarding medical
record documentation of E/M services based on the AMA CPT coding
framework and definitions. In response to comments received from RFIs
released to the public under our Patients Over Paperwork Initiative, we
proposed to address medical documentation by simplifying the payment
framework for E/M services and allowing greater flexibility on the
components practitioners could choose to document when billing Medicare
for E/M visits.
We estimate that the E/M visit documentation changes finalized in
section II.I. of this final rule may significantly reduce the amount of
time practitioners spend documenting office/outpatient E/M visits.
Although little research is available on exactly how much time
physicians and non-physician practitioners (NPPs) spend specifically
documenting E/M visits, according to one recent estimate, primary care
physicians spend on average, 84 minutes or 1.4 hours per day (24
percent of the time that they spend working within an EHR) documenting
progress notes.\75\ Another study found that primary care physicians
spend an average of 2.1 hours per day writing progress notes (both in-
clinic and remote access).\76\ Assuming an average of 20 patient visits
per day, one E/M visit per patient, and using the higher figure of 2.1
hours per day spent documenting these visits, in our proposed rule we
estimated that documentation of an average outpatient/office E/M visit
takes 6.3 minutes.\77\
---------------------------------------------------------------------------

\75\ Arndt BG, Beasley JW, Watkinson MD, et al. Tethered to the
EHR: Primary care physician workload assessment using EHR event log
data and time-motion observations. Ann Fam Med. 2017;15:427-33.
\76\ Tai-Seale M, Olson CW, Li J, et al. Electronic health
record logs indicate that physicians split time evenly between
seeing patients and desktop medicine. Health Aff (Milwood).
2017;36:655-62.
\77\ 20 patient visits per day based on the average number
reported in the Physicians Foundation 2016 Survey of America's
Physicians, available online at https://physiciansfoundation.org/wp-content/uploads/2018/01/Biennial_Physician_Survey_2016.pdf.
---------------------------------------------------------------------------

We stated our belief that our proposals to reduce redundancy in
visit documentation, to allow auxiliary staff and the beneficiary to
enter certain information in the medical record that would be verified
but not required to be re-documented by the billing practitioner, to
allow the choice of visit level and documentation based on MDM or time
as alternatives to the current framework, and to require only minimum
documentation (the amount required for a level 2 visit) for all visits
except level 1 visits may reduce the documentation time by one quarter
of the current time for the average office/outpatient visit. Under this
assumption, we estimated these proposals would save clinicians
approximately 1.6 minutes of time per office/outpatient E/M visit
billed to Medicare. For a full-time practitioner whose panel of
patients is 40 percent Medicare (60 percent other payers), this would
translate to approximately 51 hours saved per year.\78\
---------------------------------------------------------------------------

\78\ Forty percent of 20 total patients per day = 8 Medicare
vists per day. (8 visits per day)*(1.6 minutes per visit)*(240 days
per year) = 51.2 hours.
---------------------------------------------------------------------------

We noted that stakeholders had emphasized to us in public comments
that whatever reductions may be made to the E/M documentation
guidelines for purposes of Medicare payment, physicians and non-
physician practitioners will still need to document substantial
information in their progress notes for clinical, legal, operational,
quality reporting and other purposes, as well as potentially for other
payers. Furthermore, we recognized that there may be a ramp-up period
for physicians and non-physician practitioners to implement the
proposed documentation changes in their clinical workflow and EHR such
that the effects of mitigating documentation burden may not be
immediately realized. Accordingly, we believed the total amount of time
practitioners spend on E/M visit documentation may remain high, despite
the time savings that we estimated in our proposed rule could result
from our E/M documentation proposals. These and all other improvements
to payment accuracy that we proposed for CY 2019 were described in
greater detail in section II.I. of the proposed rule. We welcomed
public comments on our assumptions for the estimated reduction in
documentation burden related to our E/M visit proposals.
Comment: We received many public comments on our assumptions
regarding the potential burden reduction associated with our E/M
proposals. The commenters stated that CMS overestimated how much the
proposals would reduce burden, and noted they would reduce burden less
than CMS estimated or, according to some commenters, might increase
burden overall. Some commenters stated that the time and labor saved on
documentation would be time currently spent after hours and on
weekends, so it would not translate into additional ``work time'' or
availability to see more patients. They stated that documentation time,
in general, would remain high, due to the need to continue documenting
for clinical, legal and many other purposes such as risk adjustment,
quality reporting and other payers. Many of the commenters stated
concerns that other payers including Medicaid and secondary payers
might not adopt the same policies as Medicare, and that incongruities
in documentation rules between payers would necessitate extra effort by
practices to assess the best or required documentation method, among so
many choices, for different patients. They noted that which payer(s) a
given patient has is not always known at the outset of the visit.
Many commenters stated there would be significant burden and cost
to update EHRs and educate and train coders, staff and auditors. Also,
they noted that without appropriate medical documentation for each
visit, the proposals might result in insufficient documentation by one
member of the care team that another member might have to make up for,
and that fractured care from incomplete or insufficient documentation
might inadvertently create additional burdens, as well as impact
quality of care. While many commenters supported allowing a choice in
documentation methodology (current framework, medical decision-making,
or time), other commenters noted such a policy would increase burden
due to increased variation in how visits would be documented, and the
need to restructure EHR templates to accommodate different options and
decide which method was best for a given patient or practice. Most of
the commenters noted our proposals regarding billing eligibility and
supporting documentation for the proposed add-on codes for primary
care, other specialty care, prolonged services, and documenting using
time were unclear and might create new burdens that would equal or
exceed the current

[[Page 60069]]

burden. Some commenters stated that our proposals layered on complexity
that would counteract the goal of reducing administrative burden, and
that the negative impacts of the payment proposals would outweigh
positive impacts of documentation changes.
Other commenters were concerned about impacts on MA plan payments,
plan quality, and provider access. Some commenters were concerned that
paying for visits based on a single rate would not allow an
understanding of the complexity of care being delivered and might lead
to abuse. Another commenter noted that the proposed add-on codes to
account for care complexity would increase complexity and result in a
need for perpetual fixes from unanticipated consequences. Similar to
other commenters, this commenter was concerned that a single payment
rate would redistribute payments without reducing the burden associated
with determining the right codes, because the coding structure would
remain the same. The commenter also expressed concern that
practitioners would be less willing to see complex patients, and that
the proposal would incentivize gaming by certain specialties to make up
for lost revenue. The commenter's preferred approach was to simplify
the current guidelines and rather than implement a single payment rate,
CMS should wait for the AMA/CPT's E/M workgroup results. Finally, the
commenter recommended that if CMS finalized as proposed, CMS should
phase implementation and create a monitoring process.
Response: We understand that practitioners would continue to need
to document substantial information in the medical record for clinical,
legal and many other purposes such as risk adjustment, quality
reporting, productivity measures and potentially other payers. In
making our proposal, we did not aim to eliminate the need to document
any history, exam, and/or MDM, but rather, we ocused on eliminating
unnecessary, and outdated requirements that are associated with payment
for visit ``levels.'' This would allow the practitioner to document
what is clinically relevant and needed to support the service within
whatever framework they chose to apply--along with medical necessity--
rather than outdated aspects of the current guidelines. We understand
that other payers might not adopt the same approach, at least not in
the short term. The AMA/CPT has stated an intention to revise the E/M
code set by 2020 or 2021, which would help to establish uniformity
among payers. However, we agree with the commenters that it would be
critical to allow time for education, changing workflows and billing
systems. We understand that particularly in the initial year(s) of any
changes, there would be a cost to these activities for practitioners
and providers, including a cost to update EHRs. We are reducing our
estimate of burden reduction to account for these issues.
We note that we believe that time physicians spend fulfilling
current documentation requirements on evenings and weekends are
burdensome, and that even if that additional time would not necessarily
be spent seeing additional patients, that time is a quantifiable
resource cost to physicians and other practitioners.
After considering the comments, we adjusted our proposed burden
reduction estimate, including our estimates on the documentation of an
average outpatient/office E/M. We are still assuming an average of 20
patient visits per day, one E/M visit per patient, but instead are
using the more conservative figure of 1.4 hours per day spent
documenting E/M visits that we identified in our review of available
research. As a result, we estimate that documentation of an average
outpatient/office E/M visit takes 4.2 minutes versus our initial
estimate of 6.3 minutes. The final rule estimated time savings is
monetized into practitioner wages and summarized as follows.

Table 105--Estimated Burden Reduction for E/M Documentation Final Policies
[Practitioner wages]
--------------------------------------------------------------------------------------------------------------------------------------------------------
2023 and annually
2019 2020 2021 2022 thereafter
--------------------------------------------------------------------------------------------------------------------------------------------------------
Grand Total.............................................. $84,059,794.68 $84,059,794.68 $298,522,913.92 $405,754,473.54 $512,986,033.15
--------------------------------------------------------------------------------------------------------------------------------------------------------

We calculated the time savings associated with documentation
changes annually, and converted this time to practitioner wages using
2016 hourly wage data from the Bureau of Labor Statistics (BLS) \79\
multiplied by two to adjust for overhead and benefits. We adjusted for
the estimated proportion of impacted visits furnished by NPPs earning
lower wages than physicians, which we acknowledge is unclear due to the
ability to report services as ``incident to'' a physician when they are
furnished directly by an NPP. We approximated the portion attributable
to NPP wages using the number of visits directly reported by NPPs
(reported with a specialty of NP, PA, CNS or CNM).
---------------------------------------------------------------------------

\79\ https://www.bls.gov/oes/2016/may/oes_nat.htm.
---------------------------------------------------------------------------

The estimated savings for 2019 and 2020 are for the initial changes
to documentation in these years (those not impacted by coding and
payment changes, including provisions to no longer require
documentation of the medical necessity of a home visit in lieu of an
office visit and to expand current policy reducing the need to re-
document prior data in the medical record). These savings would impact
levels 2 through 5 visits, and are estimated to save 0.11 minutes \80\
per impacted visit, which translates into approximately $84 million in
wages across all impacted visits.
---------------------------------------------------------------------------

\80\ 2.5% of the 4.2 minutes we estimate that it currently takes
to document an office/outpatient E/M visit.
---------------------------------------------------------------------------

Additional savings are estimated annually starting in 2021 for the
finalized payment and coding-related changes. These savings would
impact levels 3 and 4 visits, and are estimated to save 0.63 minutes
\81\ per impacted visit, which translates into approximately $513
million annually in wages across all impacted visits. We assume half of
these estimated savings in year 1 (2021), 75 percent in year 2 (2022)
and 100 percent each subsequent year (2023 and each year thereafter) to
account for information provided in the public comments that there is

[[Page 60070]]

potentially off-setting burden associated with the continued need to
document for MA and potentially other payers, quality reporting, and
clinical, legal and other purposes, as well as ramp-up costs to update
EHRs and conduct training and education. The estimate assumes very
minimal burden associated with use and documentation of the add-on
codes for primary care and other specialty care, as well as the
extended visit add-on code and otherwise documenting using time, as we
are clarifying these policies and establishing minimal documentation
rules discussed in section II.I. of this final rule. We intend to allow
flexibility in how office/outpatient visits are documented and to allow
a choice in using the current framework, medical decision-making or
time, though we will take into consideration any changes in the code
set that may impact these options in future years.
---------------------------------------------------------------------------

\81\ We reduced the final rule time savings estimate of 25% (1.1
minutes) to 15 percent (0.63 minutes). We reduced it by 10
percentage points to account for the burden of documenting level 5
visits, as well as the level 2-4 combined visit. This is to account
for the uncertainty of the future code structure/definitions, as
well as public comments that introducing variation in documentation
choices and methods and providing for a bare bones minimum standard
could increase burden).
---------------------------------------------------------------------------

2. Modernizing Medicare Physician Payment by Recognizing Communication
Technology-Based Services
As noted in section II.D. of this final rule, for CY 2019, we aimed
to increase access for Medicare beneficiaries to physicians' services
that are routinely furnished via communication technology by clearly
recognizing a discrete set of services that are defined by and
inherently involve the use of communication technology. Accordingly, we
made several proposals for modernizing Medicare physician payment for
communication technology-based services.
The use of communication technology-based services will provide new
options for physicians to treat patients. These services could help to
avoid unnecessary office visits, could consist of services that are
already occurring but are not being separately paid, or could
constitute new services. Medicare would pay $14 per visit in the first
year for these communication technology-based services, compared with
$92 per visit for the corresponding established patient visits.
Practitioners have a choice of when to use the communication
technology-based services. Because of the low payment rate relative to
that for an office visit, we are assuming that usage of these services
will be relatively low. In addition, we expect that the number of new
or newly billable visits and subsequent treatments will outweigh the
number of times that communication technology-based services will be
used instead of more costly services. As a result, we expect that the
financial impact of paying for the communication technology-based
services will be an increase in Medicare costs. We estimate that usage
of these services will result in fewer than 1 million visits in the
first year but will eventually result in more than 19 million visits
per year, ultimately increasing payments under the PFS by about 0.2
percent. In order to maintain budget neutrality in setting proposed
rates for CY 2019, we assumed the number of services that would result
in a 0.2 percent reduction in the CF.
As with all estimates, and particularly those for new separately
billable services, this outcome is highly uncertain. Because
recognition of communication technology-based services is a new area
for healthcare coverage, the available information on which to base
estimates is limited and is usually not directly applicable,
particularly to a new Medicare payment. The cost and utilization
estimates are based on Medicare claims data together with a study
published in Health Affairs,\82\ which examined the cost and
utilization of telehealth in the private sector. While this study was
the most applicable for an estimate, we note that the results from this
program may be different because Medicare experience may differ from
private sector behavior and because the study was limited to acute
respiratory infection visits. We also note that the study cites the use
of direct-to-consumer telehealth companies, many of which provide
access to care 24 hours per day, 7 days per week, 365 days per year,
whereas the services described by HCPCS codes G2010 and G2012 are
limited to only established patients.
---------------------------------------------------------------------------

\82\ Ashwood, J.S. (2017 March) Direct-To-Consumer Telehealth
May Increase Access To Care But Does Not Decrease Spending. Health
Affairs.
---------------------------------------------------------------------------

We proposed to make separate payment for these services when
furnished by RHCs and FQHCs. A potential estimate of utilization and
overall cost of these services by RHCs and FQHCs could be derived by
comparing their use of chronic care management and other care
management services to the same services furnished by practitioners
paid under the PFS, since these care management services are also
separately billable and do not take place in-person. Based on this
comparison, and without considering potential variables and issues
specific to these services, the impact the finalized policy would be
less than $1 million in additional Medicare spending in the first year
and could eventually result in up to $20 million in spending per year
in future years. These estimates are uncertain and could change after
further consideration of the potential variables and issues specific to
these services.
3. Outpatient Therapy Services
As noted in section II.M. of this final rule, we are finalizing our
proposal to end functional reporting for outpatient therapy services as
part of our burden reduction efforts in response to the RFI on CMS
Flexibilities and Efficiencies that was issued in the CY 2018 PFS
proposed rule (82 FR 34172 through 34173). Under our functional
reporting system therapy practitioners and providers are required to
report, whenever functional reporting is required, non-payable HCPCS G-
codes and modifiers--typically in pairs--to convey information about
the beneficiary's functional limitation category and functional status
throughout the PT, OT, or SLP episode of care. In addition, each time
functional reporting is required on the claim, the therapy provider
must also document the functional reporting G-codes and their modifiers
in the medical record. In this final rule, we are finalizing our
proposal to eliminate this requirement that therapy practitioners and
providers report HCPCS G-codes and modifiers or document in the medical
record to convey functional reporting status for PT, OT or SLP episode
of care.
To quantify the amount of burden reduction, we estimated the total
amount of time that therapy practitioners spend doing functional
reporting. To do this, we first looked at our data for CY 2017 for
professional claims by the type of plan of care reported primarily by
therapists in private practice (TPPs), including physical therapists,
occupational therapists, and speech-language pathologists. We found
that the overall utilization of the 42 functional reporting HCPCS G-
codes totaled 15,456,421 single units, or 7,728,211 pairs.
We then considered the time, on average, it might take to report on
the claim and document in the medical record each pair of HCPCS G-
codes. We noted this includes the time it takes to make the initial
determination of the HCPCS G-code functional limitation category, as
well as the time needed to make each initial and/or subsequent
assignments for the applicable severity modifiers in order to define
the patient's functional status. We then made the assumption that it
would take between 1 minute and 1.5 minutes, on average, to report the
HCPCS G-code and modifier pair each time functional reporting is
required. Using the total utilization of G-code pairs and the range of
1 minute to 1.5 minutes, we

[[Page 60071]]

calculated that TPPs would have saved between 128,804 and 193,206 hours
(or 7,728,211 to 11,592,317 minutes) collectively in CY 2017 if the
functional reporting requirements had not been in place. We continue to
believe this is a reasonable projection for the potential savings to
TPPs, physicians and certain nonphysician practitioners in future years
with the finalization of our proposal to end functional reporting
effective January 1, 2019.
Because therapy services are also furnished by providers of
outpatient therapy services such as hospitals, SNFs and rehabilitation
agencies that submit institutional claims, typically representing a
greater amount of expenditures than practitioners submitting
professional claims, we calculated additional savings for these
providers using the same time assumptions of 1 to 1.5 minutes to report
the HCPCS G-code and modifier pair each time functional reporting is
required. Our 2017 data showed a total utilization of the functional
reporting HCPCS G-codes is 29,053,921 single units, or 14,526,961
pairs, indicating that therapy providers would collectively save
between 242,116 to 363,174 hours (or 14,526,961 to 21,790,442 minutes)
for CY 2017 if the functional reporting requirements had not been
effective during that year.
As discussed in section II.M. of this final rule, we received many
comments on our burden reduction proposal to eliminate our functional
reporting requirements, and nearly all comments were supportive. We
believe it is reasonable to estimate that in CY 2019 TPPs and other
practitioners submitting professional claims and therapists working for
providers submitting institutional claims will collectively save, at a
minimum, the same number of collective hours we calculated they would
save for CY 2017, as specified previously in this RIA, with dates of
service on and after January 1, 2019.
4. Physician Supervision of Diagnostic Imaging Procedures
We believe that the changes to the physician supervision
requirements for RAs furnishing diagnostic imaging procedures as
described in section II.F. of this final rule will significantly reduce
burden for physicians. While approximately 215,000 diagnostic imaging
services per year are currently performed that require personal
supervision, we are not able to determine the number of these services
that are performed by an RA due to limitations in the claims data. As a
result, we are not able to quantify the amount of time potentially
saved by physicians and practitioners under the policy we are
finalizing to require direct supervision of diagnostic imaging
procedures done by RAs in cases where personal supervision would
ordinarily be required. That said, stakeholders representing the
practitioner community have indicated that changing the required
supervision level for RAs will result in a redistribution of workload
from radiologists to RAs, potentially resulting in improved practice
efficiency and patient satisfaction. Stakeholders have stated that
practitioners that utilize RAs have experienced improvements in
practice efficiency, as use of RAs allows radiologists more time for
professional services such as interpretation of images, and these
practitioners cite greater flexibility that results in reduced wait
times. Furthermore, stakeholders contend that the Medicare supervision
requirements currently create disincentives to use RAs, as
practitioners cannot make full use of them for Medicare patients, and
the change to the supervision requirement would allow RAs to be more
fully utilized. For these reasons, we believe the change in supervision
requirements we are finalizing for RAs will contribute to burden
reduction for physicians and practitioners providing diagnostic imaging
procedures for Medicare beneficiaries.
5. Beneficiary Liability
Many proposed policy changes could result in a change in
beneficiary liability as it relates to coinsurance (which is 20 percent
of the fee schedule amount, if applicable for the particular provision
after the beneficiary has met the deductible). To illustrate this
point, as shown in our public use file Impact on Payment for Selected
Procedures available on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/, the CY 2018
national payment amount in the nonfacility setting for CPT code 99203
(Office/outpatient visit, new) was $109.80, which means that in CY
2018, a beneficiary would be responsible for 20 percent of this amount,
or $21.96. Based on this final rule, using the CY 2019 CF, the CY 2019
national payment amount in the nonfacility setting for CPT code 99203,
as shown in the Impact on Payment for Selected Procedures public use
file, is $109.92, which means that, in CY 2019, the final beneficiary
coinsurance for this service would be $21.98.

J. Impact on Beneficiaries in the Quality Payment Program

There are several changes in this rule that would have an effect on
beneficiaries. In general, we believe that many of these changes,
including those intended to improve accuracy in payment through regular
updates to the inputs used to calculate payments under the PFS, would
have a positive impact and improve the quality and value of care
provided to Medicare beneficiaries. For example, several of the new
proposed measures include patient-reported outcomes, which may be used
to help patients make more informed decisions about treatment options.
Patient-reported outcome measures provide information on a patient's
health status from the patient's point of view and may also provide
valuable insights on factors such as quality of life, functional
status, and overall disease experience, which may not otherwise be
available through routine clinical data collection. Patient-reported
outcomes are factors frequently of interest to patients when making
decisions about treatment.\83\ Further, the proposed policy changes in
the Promoting Interoperability performance category shifts the focus to
the interoperable, seamless exchange of electronic information. With
the requirement that program participants use 2015 Edition CEHRT, the
interoperable exchange of patient health information should be easier
because the certification criteria are designed to facilitate
information exchange. In combination with the newly proposed Promoting
Interoperability measure to receive and incorporate health information,
beneficiaries should begin to experience improved care coordination and
care transitions because clinicians have improved access to the
beneficiaries' health information across the spectrum of care.
---------------------------------------------------------------------------

\83\ Institute of Medicine. 2013. Delivering High-Quality Cancer
Care: Charting a New Course for a System in Crisis. Washington, DC:
The National Academies Press. https://doi.org/10.17226/18359.
---------------------------------------------------------------------------

Impact on Other Health Care Programs and Providers
We estimate that CY 2019 Quality Payment Program will not have a
significant economic effect on eligible clinicians and groups and
believe that MIPS policies, along with increasing participation in APMs
over time may succeed in improving quality and reducing costs. This may
in turn result in beneficial effects on both patients and some
clinicians, and we intend to continue focusing on clinician-driven,
patient-centered care.

[[Page 60072]]

K. Estimating Regulatory Familiarization Costs

If regulations impose administrative costs on private entities,
such as the time needed to read and interpret this rule, we should
estimate the cost associated with regulatory review. Due to the
uncertainty involved with accurately quantifying the number of entities
that will review the rule, we assume that the total number of unique
commenters on last year's rule will be the number of reviewers of this
rule. We acknowledge that this assumption may understate or overstate
the costs of reviewing this rule. It is possible that not all
commenters reviewed last year's rule in detail, and it is also possible
that some reviewers chose not to comment on the rule. For these reasons
we thought that the number of past commenters would be a fair estimate
of the number of reviewers of this rule. We welcomed any comments on
the approach in estimating the number of entities which will review
this rule.
We also recognize that different types of entities are in many
cases affected by mutually exclusive sections of this rule, and
therefore for the purposes of our estimate we assume that each reviewer
reads approximately 50 percent of the rule. We sought comments on this
assumption.
Using the wage information from the BLS for medical and health
service managers (Code 11-9111), we estimate that the cost of reviewing
this rule is $107.38 per hour, including overhead and fringe benefits
https://www.bls.gov/oes/current/oes_nat.htm. Assuming an average
reading speed, we estimate that it would take approximately 8.0 hours
for the staff to review half of this rule. For each facility that
reviews the rule, the estimated cost is $859.04 (8.0 hours x $107.38).
Therefore, we estimated that the total cost of reviewing this
regulation is $5,105,275 ($859.04 x 5,943 reviewers).

L. Accounting Statement

As required by OMB Circular A-4 (available at https://www.whitehouse.gov/omb/circulars/a004/a-4.pdf), in Tables 106 and 107
(Accounting Statements), we have prepared an accounting statement. This
estimate includes growth in incurred benefits from CY 2018 to CY 2019
based on the FY 2019 President's Budget baseline.

Table 106--Accounting Statement: Classification of Estimated
Expenditures
------------------------------------------------------------------------
Category Transfers
------------------------------------------------------------------------
CY 2019 Annualized Monetized Transfers. Estimated increase in
expenditures of $0.3 billion
for PFS CF update.
From Whom To Whom?..................... Federal Government to
physicians, other
practitioners and providers
and suppliers who receive
payment under Medicare.
------------------------------------------------------------------------

Table 107--Accounting Statement: Classification of Estimated Costs,
Transfer, and Savings
------------------------------------------------------------------------
Category Transfer
------------------------------------------------------------------------
CY 2019 Annualized Monetized Transfers $0.1 billion.
of beneficiary cost coinsurance.
From Whom to Whom?..................... Beneficiaries to Federal
Government.
------------------------------------------------------------------------

M. Conclusion

The analysis in the previous sections, together with the remainder
of this preamble, provided an initial Regulatory Flexibility Analysis.
The previous analysis, together with the preceding portion of this
preamble, provides an RIA. In accordance with the provisions of
Executive Order 12866, this regulation was reviewed by the Office of
Management and Budget.

List of Subjects

42 CFR Part 405

Administrative practice and procedure, Diseases, Health facilities,
Health professions, Medical devices, Medicare, Reporting and
recordkeeping requirements, Rural areas, X-rays.

42 CFR Part 410

Health facilities, Health professions, Kidney diseases,
Laboratories, Medicare, Reporting and recordkeeping requirements, Rural
areas, X-rays.

42 CFR Part 411

Diseases, Medicare, Reporting and recordkeeping requirements.

42 CFR Part 414

Administrative practice and procedure, Biologics, Drugs, Health
facilities, Health professions, Kidney diseases, Medicare, Reporting
and recordkeeping requirements.

42 CFR Part 415

Health facilities, Health professions, Medicare, Reporting and
recordkeeping requirements.

42 CFR Part 425

Administrative practice and procedure, Health facilities, Health
professions, Medicare, Reporting and recordkeeping requirements.

42 CFR Part 495

Administrative practice and procedure, Health facilities, Health
maintenance organizations (HMO), Health professions, Health records,
Medicaid, Medicare, Penalties, Reporting and recordkeeping
requirements.
For the reasons set forth in the preamble, the Centers for Medicare
& Medicaid Services amends 42 CFR chapter IV as set forth below:

PART 405--FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED

0
1. The authority citation for part 405 is revised to read as follows:

Authority: 42 U.S.C. 405(a), 1302, 1320b-12, 1395x, 1395y(a),
1395ff, 1395hh, 1395kk, 1395rr, and 1395ww(k)) and 42 U.S.C. 263a.

0
2. Section 405.2401 is amended in paragraph (b) by--
0
a. Revising the introductory text of the definition of ``Federally
qualified health center''; and
0
b. Revising the definition of ``Secretary''.
The revisions read as follows:

Sec. 405.2401 Scope and definitions.

* * * * *
(b) * * *
Federally qualified health center (FQHC) means an entity that has
entered into an agreement with CMS to meet Medicare program
requirements under Sec. 405.2434 and--
* * * * *

[[Page 60073]]

Secretary means the Secretary of Health and Human Services or his
or her delegate.
* * * * *

0
3. Section 405.2462 is amended by revising paragraph (g) introductory
text to read as follows:

Sec. 405.2462 Payment for RHC and FQHC services.

* * * * *
(g) To receive payment, the RHC or FQHC must do all of the
following:
* * * * *

0
4. Section 405.2464 is amended by--
0
a. Revising paragraphs (a)(1), (b) heading, (b)(1), (c), and (d); and
0
b. Adding a new paragraph (e)
The revisions and additions read as follows:

Sec. 405.2464 Payment rate.

(a) * * *
(1) Except as specified in paragraphs (d) and (e) of this section,
an RHC that is authorized to bill under the reasonable cost system is
paid an all-inclusive rate that is determined by the MAC at the
beginning of the cost reporting period.
* * * * *
(b) Payment rate for FQHCs that are authorized to bill under the
prospective payment system. (1) Except as specified in paragraphs (d)
and (e) of this section, a per diem rate is calculated by CMS by
dividing total FQHC costs by total FQHC daily encounters to establish
an average per diem cost.
* * * * *
(c) Payment for care management services. For chronic care
management services furnished between January 1, 2016 and December 31,
2017, payment to RHCs and FQHCs is at the physician fee schedule
national non-facility payment rate. For care management services
furnished on or after January 1, 2018, payment to RHCs and FQHCs is at
the rate set for each of the RHC and FQHC payment codes for care
management services.
(d) Payment for FQHCs that are authorized to bill as grandfathered
tribal FQHCs. Grandfathered tribal FQHCs are paid at the outpatient per
visit rate for Medicare as set annually by the Indian Health Service
for each beneficiary visit for covered services. There are no
adjustments to this rate.
(e) Payment for communication technology-based and remote
evaluation services. For communication technology-based and remote
evaluation services furnished on or after January 1, 2019, payment to
RHCs and FQHCs is at the rate set for each of the RHC and FQHC payment
codes for communication technology-based and remote evaluation
services.

PART 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS

0
5. The authority citation for part 410 is revised to read as follows:

Authority: 42 U.S.C. 1302, 1395m, 1395hh, 1395rr, and 1395ddd.

0
6. Section 410.32 is amended by adding paragraph (b)(4) to read as
follows:

Sec. 410.32 Diagnostic x-ray tests, diagnostic laboratory tests, and
other diagnostic tests: Conditions.

* * * * *
(b) * * *
(4) Supervision requirement for RRA or RPA. Diagnostic tests that
are performed by a registered radiologist assistant (RRA) who is
certified and registered by the American Registry of Radiologic
Technologists or a radiology practitioner assistant (RPA) who is
certified by the Certification Board for Radiology Practitioner
Assistants, and that would otherwise require a personal level of
supervision as specified in paragraph (b)(3) of this section, may be
furnished under a direct level of physician supervision to the extent
permitted by state law and state scope of practice regulations.
* * * * *

Sec. 410.59 [Amended]

0
7. Section 410.59 is amended by removing paragraph (a)(4).

Sec. 410.60 [Amended]

0
8. Section 410.60 is amended by removing paragraph (a)(4).

0
9. Section 410.61 is amended by revising paragraph (c) to read as
follows:

Sec. 410.61 Plan of treatment requirements for outpatient
rehabilitation services.

* * * * *
(c) Content of the plan. The plan prescribes the type, amount,
frequency, and duration of the physical therapy, occupational therapy,
or speech-language pathology services to be furnished to the
individual, and indicates the diagnosis and anticipated goals.
* * * * *

Sec. 410.62 [Amended]

0
10. Section 410.62 is amended by removing paragraph (a)(4).

0
11. Section 410.78 is amended by--
0
a. Adding paragraphs (b)(3)(ix), (x), (xi), and (xii);
0
b. Revising paragraph (b)(4) introductory text, and
0
c. Adding paragraph (b)(4)(iv).
The additions and revision read as follows:

Sec. 410.78 Telehealth services.

* * * * *
(b) * * *
(3) * * *
(ix) A renal dialysis facility (only for purposes of the home
dialysis monthly ESRD-related clinical assessment in section
1881(b)(3)(B) of the Act);
(x) The home of an individual (only for purposes of the home
dialysis ESRD-related clinical assessment in section 1881(b)(3)(B) of
the Act).
(xi) A mobile stroke unit (only for purposes of diagnosis,
evaluation, or treatment of symptoms of an acute stroke provided in
accordance with section 1834(m)(6) of the Act).
(xii) The home of an individual (only for purposes of treatment of
a substance use disorder or a co-occurring mental health disorder,
furnished on or after July 1, 2019, to an individual with a substance
use disorder diagnosis.
(4) Except as provided in paragraph (b)(4)(iv) of this section,
originating sites must be:
* * * * *
(iv) The geographic requirements specified in paragraph (b)(4) of
this section do not apply to the following telehealth services:
(A) Home dialysis monthly ESRD-related clinical assessment services
furnished on or after January 1, 2019, at an originating site described
in paragraphs (b)(3)(vi), (ix) or (x) of this section, in accordance
with section 1881(b)(3)(B) of the Act; and
(B) Services furnished on or after January 1, 2019, for purposes of
diagnosis, evaluation, or treatment of symptoms of an acute stroke.
(C) Services furnished on or after July 1, 2019 to an individual
with a substance use disorder diagnosis, for purposes of treatment of a
substance use disorder or a co-occurring mental health disorder.
* * * * *

Sec. 410.105 [Amended]

0
12. Section 410.105 is amended--
0
a. In paragraph (c)(1)(ii) by removing the phrase ``that are consistent
with the patient function reporting on the claims for services''; and
0
b. By removing paragraph (d).

PART 411--EXCLUSIONS FROM MEDICARE AND LIMITATIONS ON MEDICARE
PAYMENT

0
13. The authority citation for part 411 is revised to read as follows:

Authority: 42 U.S.C. 1302, 1395w-101 through 1395w-152, 1395hh,
and 1395nn.

[[Page 60074]]

0
14. Section 411.353 is amended by--
0
a. Revising paragraph (g)(1); and
0
b. Removing and reserving paragraph (g)(2).
The revision reads as follows:

Sec. 411.353 Prohibition on certain referrals by physicians and
limitations on billing.

* * * * *
(g) * * *
(1) An entity may submit a claim or bill and payment may be made to
an entity that submits a claim or bill for a designated health service
if--
(i) The compensation arrangement between the entity and the
referring physician fully complies with an applicable exception in this
subpart except with respect to the signature requirement of the
exception; and
(ii) The parties obtain the required signature(s) within 90
consecutive calendar days immediately following the date on which the
compensation arrangement became noncompliant and the compensation
arrangement otherwise complies with all criteria of the applicable
exception.
(2) [Reserved]

0
15. Section 411.354 is amended by adding paragraph (e) to read as
follows:

Sec. 411.354 Financial relationship, compensation, and ownership or
investment interest.

* * * * *
(e) Special rule on compensation arrangements--(1) Application.
This paragraph (e) applies only to compensation arrangements as defined
in section 1877 of the Act and this subpart.
(2) Writing requirement. In the case of any requirement in this
subpart for a compensation arrangement to be in writing, such
requirement may be satisfied by a collection of documents, including
contemporaneous documents evidencing the course of conduct between the
parties.

PART 414--PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES

0
16. The authority citation for part 414 is revised to read as follows:

Authority: 42 U.S.C. 1302, 1395hh, and 1395rr(b)(l).

0
17. Section 414.65 is amended by--
0
a. Revising paragraph (a) introductory text;
0
b. Removing paragraph (a)(1);
0
c. Redesignating paragraphs (a)(2) and (3), as paragraphs (a)(1) and
(2), respectively; and
0
d. Adding paragraph (b)(3).
The revision and addition reads as follows:

Sec. 414.65 Payment for telehealth services.

(a) Professional service. The Medicare payment amount for
telehealth services described under Sec. 410.78 of this chapter is
equal to the current fee schedule amount applicable for the service of
the physician or practitioner, subject to paragraphs (a)(1) and (2) of
this section, but must be made in accordance with the following
limitations:
* * * * *
(b) * * *
(3) No originating site facility fee payment is made to an
originating site described in Sec. 410.78(b)(3)(x), (xi), or (xii); or
to an originating site for services furnished under the exception at
Sec. 410.78(b)(4)(iv)(A) or (B) of this chapter.
* * * * *

0
18. Section 414.94 is amended--
0
a. In paragraph (b), by revising the definition of ``Applicable
setting''; and
0
b. By revising paragraphs (i)(3), (j), and (k) introductory text.
The revisions read as follows:

Sec. 414.94 Appropriate use criteria for advanced diagnostic imaging
services.

* * * * *
(b) * * *
Applicable setting means a physician's office, a hospital
outpatient department (including an emergency department), an
ambulatory surgical center, an independent diagnostic testing facility,
and any other provider-led outpatient setting determined appropriate by
the Secretary.
* * * * *
(i) * * *
(3) Significant hardships for ordering professionals who experience
any of the following:
(i) Insufficient internet access.
(ii) EHR or CDSM vendor issues.
(iii) Extreme and uncontrollable circumstances.
(j) Consulting. (1) Except as specified in paragraphs (i) and
(j)(2) of this section, ordering professionals must consult specified
applicable AUC through qualified CDSMs for applicable imaging services
furnished in an applicable setting, paid for under an applicable
payment system, and ordered on or after January 1, 2020.
(2) Ordering professionals may delegate the consultation with
specified applicable AUC required under paragraph (j)(1) of this
section to clinical staff acting under the direction of the ordering
professional.
(k) Reporting. The following information must be reported on
Medicare claims for advanced diagnostic imaging services furnished in
an applicable setting, paid for under an applicable payment system
defined in paragraph (b) of this section, and ordered on or after
January 1, 2020:
* * * * *

0
19. Section 414.502 is amended in the definition of ``Applicable
laboratory'' by adding paragraph (2)(i), adding and reserving paragraph
(2)(ii), and revising paragraph (3) introductory text to read as
follows:

Sec. 414.502 Definitions.

* * * * *
Applicable laboratory * * *
(2) * * *
(i) For hospital outreach laboratories--bills Medicare Part B on
the CMS 1450 under bill type 14x;
(ii) [Reserved]
(3) In a data collection period, receives more than 50 percent of
its Medicare revenues, which includes fee-for-service payments under
Medicare Parts A and B, prescription drug payments under Medicare Part
D, and any associated Medicare beneficiary deductible or coinsurance
for services furnished during the data collection period from one or a
combination of the following sources:
* * * * *

0
20. Section 414.610 is amended--
0
a. In paragraphs (c)(1)(ii) introductory text and (c)(5)(ii) by
removing the date ``December 31, 2017'' and adding in its place the
date ``December 31, 2022''; and
0
b. By revising paragraph (c)(8).
The revision reads as follows:

Sec. 414.610 Basis of payment.

* * * * *
(c) * * *
(8) Transport of an individual with end-stage renal disease for
renal dialysis services. For ambulance services furnished during the
period October 1, 2013 through September 30, 2018, consisting of non-
emergency basic life support (BLS) services involving transport of an
individual with end-stage renal disease for renal dialysis services (as
described in section 1881(b)(14)(B) of the Act) furnished other than on
an emergency basis by a provider of services or a renal dialysis
facility, the fee schedule amount otherwise applicable (both base rate
and mileage) is reduced by 10 percent. For such services furnished on
or after October 1, 2018, the fee schedule amount otherwise applicable
(both base rate and mileage) is reduced by 23 percent.
* * * * *

Sec. 414.904 [Amended]

0
21. Section 414.904 is amended in paragraph (e)(4) by removing the
phrase

[[Page 60075]]

``acquisition cost or the applicable Medicare Part B drug payment'' and
adding in its place the phrase ``acquisition cost or the Medicare Part
B drug payment''.

0
22. Section 414.1305 is amended by--
0
a. Revising the definition of ``Ambulatory Surgical Center (ASC)-based
MIPS eligible clinician'';
0
b. Adding in alphabetical order definitions for ``Collection type'' and
``Health IT vendor'';
0
c. Revising the definitions of ``High priority measure'', ``Hospital-
based MIPS eligible clinician'', and ``Low-volume threshold'';
0
d. Adding in alphabetical order a definition for ``MIPS determination
period'';
0
e. Revising the definitions of ``MIPS eligible clinician'', ``Non-
patient facing MIPS eligible clinician'', ``Qualified Clinical Data
Registry (QCDR)'', ``Qualifying APM Participant (QP)'', and ``Small
practice''; and
0
f. Adding in alphabetical order a definition for ``Submission type'',
``Submitter type'', and ``Third party intermediary''.
The revisions and additions read as follows:

Sec. 414.1305 Definitions.

* * * * *
Ambulatory Surgical Center (ASC)-based MIPS eligible clinician
means:
(1) For the 2019 and 2020 MIPS payment years, a MIPS eligible
clinician who furnishes 75 percent or more of his or her covered
professional services in sites of service identified by the Place of
Service (POS) codes used in the HIPAA standard transaction as an
ambulatory surgical center setting based on claims for a period prior
to the performance period as specified by CMS; and
(2) Beginning with the 2021 MIPS payment year, a MIPS eligible
clinician who furnishes 75 percent or more of his or her covered
professional services in sites of service identified by the POS codes
used in the HIPAA standard transaction as an ambulatory surgical center
setting based on claims for the MIPS determination period.
* * * * *
Collection type means a set of quality measures with comparable
specifications and data completeness criteria, as applicable,
including, but not limited to: electronic clinical quality measures
(eCQMs); MIPS Clinical Quality Measures (MIPS CQMs), QCDR measures,
Medicare Part B claims measures, CMS Web Interface measures, the CAHPS
for MIPS survey, and administrative claims measures.
* * * * *
Health IT vendor means an entity that supports the health IT
requirements on behalf of a MIPS eligible clinician (including
obtaining data from a MIPS eligible clinician's CEHRT).
* * * * *
High priority measure means:
(1) For the 2019 and 2020 MIPS payment years, an outcome (including
intermediate-outcome and patient-reported outcome), appropriate use,
patient safety, efficiency, patient experience, or care coordination
quality measure.
(2) Beginning with the 2021 MIPS payment year, an outcome
(including intermediate-outcome and patient-reported outcome),
appropriate use, patient safety, efficiency, patient experience, care
coordination, or opioid-related quality measure.
Hospital-based MIPS eligible clinician means:
(1) For the 2019 and 2020 MIPS payment years, a MIPS eligible
clinician who furnishes 75 percent or more of his or her covered
professional services in sites of service identified by the Place of
Service (POS) codes used in the HIPAA standard transaction as an
inpatient hospital, on-campus outpatient hospital, off campus-
outpatient hospital, or emergency room setting based on claims for a
period prior to the performance period as specified by CMS; and
(2) Beginning with the 2021 MIPS payment year, a MIPS eligible
clinician who furnishes 75 percent or more of his or her covered
professional services in sites of service identified by the POS codes
used in the HIPAA standard transaction as an inpatient hospital, on-
campus outpatient hospital, off campus outpatient hospital, or
emergency room setting based on claims for the MIPS determination
period.
* * * * *
Low-volume threshold means:
(1) For the 2019 MIPS payment year, the low-volume threshold that
applies to an individual eligible clinician, group, or APM Entity group
that, during the low-volume threshold determination period described in
paragraph (4) of this definition, has Medicare Part B allowed charges
less than or equal to $30,000 or provides care for 100 or fewer
Medicare Part B-enrolled individuals.
(2) For the 2020 MIPS payment year, the low-volume threshold that
applies to an individual eligible clinician, group, or APM Entity group
that, during the low-volume threshold determination period described in
paragraph (4) of this definition, has allowed charges for covered
professional services less than or equal to $90,000 or furnishes
covered professional services to 200 or fewer Medicare Part B-enrolled
individuals.
(3) Beginning with the 2021 MIPS payment year, the low-volume
threshold that applies to an individual eligible clinician, group, or
APM Entity group that, during the MIPS determination period, has
allowed charges for covered professional services less than or equal to
$90,000, furnishes covered professional services to 200 or fewer
Medicare Part B-enrolled individuals, or furnishes 200 or fewer covered
professional services to Medicare Part B-enrolled individuals.
(4) For the 2019 and 2020 MIPS payment years, the low-volume
threshold determination period is a 24-month assessment period
consisting of:
(i) An initial 12-month segment that spans from the last 4 months
of the calendar year 2 years prior to the performance period through
the first 8 months of the calendar year preceding to the performance
period; and
(ii) A second 12-month segment that spans from the last 4 months of
the calendar year 1 year prior to the performance period through the
first 8 months of the calendar year performance period. An individual
eligible clinician, group, or APM Entity group that is identified as
not exceeding the low-volume threshold during the initial 12-month
segment will continue to be excluded under Sec. 414.1310(b)(1)(iii)
for the applicable year regardless of the results of the second 12-
month segment analysis. For the 2019 MIPS payment year, each segment of
the low-volume threshold determination period includes a 60-day claims
run out. For the 2020 MIPS payment year, each segment of the low-volume
threshold determination period includes a 30-day claims run out.
* * * * *
MIPS determination period means:
(1) Beginning with the 2021 MIPS payment year, a 24-month
assessment period consisting of:
(i) An initial 12-month segment beginning on October 1 of the
calendar year 2 years prior to the applicable performance period and
ending on September 30 of the calendar year preceding the applicable
performance period, and that includes a 30-day claims run out; and
(ii) A second 12-month segment beginning on October 1 of the
calendar year preceding the applicable performance period and ending on
September 30 of the calendar year in which the applicable performance
period occurs.
(2) Subject to Sec. 414.1310(b)(1)(iii), an individual eligible
clinician, group, or APM Entity group that is identified as not
exceeding the low-volume threshold

[[Page 60076]]

or as having special status during the first segment of the MIPS
determination period will be identified as such for the applicable MIPS
payment year regardless of the results of the second segment of the
MIPS determination period. An individual eligible clinician, group, or
APM Entity group for which the unique billing TIN and NPI combination
is established during the second segment of the MIPS determination
period will be assessed based solely on the results of such segment.
MIPS eligible clinician as identified by a unique billing TIN and
NPI combination used to assess performance, means any of the following
(except as excluded under Sec. 414.1310(b)):
(1) For the 2019 and 2020 MIPS payment years:
(i) A physician (as defined in section 1861(r) of the Act);
(ii) A physician assistant, a nurse practitioner, and clinical
nurse specialist (as such terms are defined in section 1861(aa)(5) of
the Act);
(iii) A certified registered nurse anesthetist (as defined in
section 1861(bb)(2) of the Act); and
(iv) A group that includes such clinicians.
(2) For the 2021 MIPS payment year and future years:
(i) A clinician described in paragraph (1) of this definition;
(ii) A physical therapist or occupational therapist;
(iii) A qualified speech-language pathologist;
(iv) A qualified audiologist (as defined in section 1861(ll)(3)(B)
of the Act);
(v) A clinical psychologist (as defined by the Secretary for
purposes of section 1861(ii) of the Act);
(vi) A registered dietician or nutrition professional; and
(vii) A group that includes such clinicians.
* * * * *
Non-patient facing MIPS eligible clinician means:
(1) For the 2019 and 2020 MIPS payment year, an individual MIPS
eligible clinician who bills 100 or fewer patient facing encounters
(including Medicare telehealth services defined in section 1834(m) of
the Act), as described in paragraph (3) of this definition, during the
non-patient facing determination period described in paragraph (4) of
this definition, and a group or virtual group provided that more than
75 percent of the NPIs billing under the group's TIN or virtual group's
TINs, as applicable, meet the definition of a non-patient facing
individual MIPS eligible clinician.
(2) Beginning with the 2021 MIPS payment year, an individual MIPS
eligible clinician who bills 100 or fewer patient facing encounters
(including Medicare telehealth services defined in section 1834(m) of
the Act), as described in paragraph (3) of this definition, during the
MIPS determination period, and a group or virtual group provided that
more than 75 percent of the NPIs billing under the group's TIN or
virtual group's TINs, as applicable, meet the definition of a non-
patient facing individual MIPS eligible clinician.
(3) For purposes of this definition, a patient-facing encounter is
an instance in which the individual MIPS eligible clinician or group
bills for items and services furnished such as general office visits,
outpatient visits, and procedure codes under the PFS, as specified by
CMS.
(4) For the 2019 and 2020 MIPS payment year, the non-patient facing
determination period is a 24-month assessment period consisting of:
(i) An initial 12-month segment that spans from the last 4 months
of the calendar year 2 years prior to the performance period through
the first 8 months of the calendar year preceding the performance
period; and
(ii) A second 12-month segment that spans from the last 4 months of
the calendar year 1 year prior to the performance period through the
first 8 months of the calendar year performance period. An individual
eligible MIPS clinician, group, or virtual group that is identified as
non-patient facing during the initial 12-month segment will continue to
be considered non-patient facing for the applicable year regardless of
the results of the second 12-month segment analysis. For the 2019 MIPS
payment year, each segment of the non-patient facing determination
period includes a 60-day claims run out. For the 2020 MIPS payment year
and future years, each segment of the non-patient facing determination
period includes a 30-day claims run out.
* * * * *
Qualified clinical data registry (QCDR) means:
(1) For the 2019, 2020 and 2021 MIPS payment year, a CMS-approved
entity that has self-nominated and successfully completed a
qualification process to determine whether the entity may collect
medical or clinical data for the purpose of patient and disease
tracking to foster improvement in the quality of care provided to
patients.
(2) Beginning with the 2022 MIPS payment year, an entity that
demonstrates clinical expertise in medicine and quality measurement
development experience and collects medical or clinical data on behalf
of a MIPS eligible clinician for the purpose of patient and disease
tracking to foster improvement in the quality of care provided to
patients.
* * * * *
Qualifying APM participant (QP) means an eligible clinician
determined by CMS to have met or exceeded the relevant QP payment
amount or QP patient count threshold under Sec. 414.1430(a)(1),
(a)(3), (b)(1), or (b)(3) for a year based on participation in an APM
Entity that is also participating in an Advanced APM.
* * * * *
Small practice means:
(1) For the 2019 MIPS payment year, a TIN consisting of 15 or fewer
eligible clinicians.
(2) For the 2020 MIPS payment year, a TIN consisting of 15 or fewer
eligible clinicians during a 12-month assessment period that spans from
the last 4 months of the calendar year 2 years prior to the performance
period through the first 8 months of the calendar year preceding the
performance period and includes a 30-day claims run out.
(3) Beginning with the 2021 MIPS payment year, a TIN consisting of
15 or fewer eligible clinicians during the MIPS determination period.
* * * * *
Submission type means the mechanism by which the submitter type
submits data to CMS, including, but not limited to: Direct, log in and
upload, log in and attest, Medicare Part B claims and the CMS Web
Interface.
Submitter type means the MIPS eligible clinician, group, virtual
group, or third party intermediary acting on behalf of a MIPS eligible
clinician, group, or virtual group, as applicable, that submits data on
measures and activities under MIPS.
Third party intermediary means an entity that has been approved
under Sec. 414.1400 to submit data on behalf of a MIPS eligible
clinician, group, or virtual group for one or more of the quality,
improvement activities, and promoting interoperability performance
categories.
* * * * *

0
23. Section 414.1310 is amended by revising paragraphs (a), (b)(1)(ii),
(iii), (d), (e)(1) and (2) to read as follows:

Sec. 414.1310 Applicability.

(a) Program implementation. Except as specified in paragraph (b) of
this section, MIPS applies to payments for

[[Page 60077]]

covered professional services furnished by MIPS eligible clinicians on
or after January 1, 2019.
(b) * * *
(1) * * *
(ii) Is a Partial Qualifying APM Participant and does not elect to
participate in MIPS as a MIPS eligible clinician; or
(iii) Does not exceed the low-volume threshold. Beginning with the
2021 MIPS payment year, if an individual eligible clinician, group, or
APM Entity group in a MIPS APM exceeds at least one, but not all, of
the low-volume threshold criteria and elects to participate in MIPS as
a MIPS eligible clinician, the individual eligible clinician, group, or
APM Entity group is treated as a MIPS eligible clinician for the
applicable MIPS payment year. For such solo practitioners and groups
that elect to participate in MIPS as a virtual group (except for APM
Entity groups in MIPS APMs), the virtual group election under Sec.
414.1315 constitutes an election under this paragraph and results in
the solo practitioners and groups being treated as MIPS eligible
clinicians for the applicable MIPS payment year. For such APM Entity
groups in MIPS APMs, only the APM Entity group election can result in
the APM Entity group being treated as MIPS eligible clinicians for the
applicable MIPS payment year.
* * * * *
(d) Clarification. In no case will a MIPS payment adjustment factor
(or additional MIPS payment adjustment factor) apply to payments for
items and services furnished during a year by a eligible clinician,
including an eligible clinician described in paragraph (b) or (c) of
this section, who is not a MIPS eligible clinician, including an
eligible clinician who voluntarily reports on applicable measures and
activities under MIPS.
(e) * * *
(1) Except as provided under Sec. 414.1370(f)(2), each MIPS
eligible clinician in the group will receive a MIPS payment adjustment
factor (or additional MIPS payment adjustment factor) based on the
group's combined performance assessment.
(2) For individual MIPS eligible clinicians to participate in MIPS
as a group, all of the following requirements must be met:
(i) Groups must meet the definition of a group at all times during
the applicable performance period.
(ii) Individual eligible clinicians that elect to participate in
MIPS as a group must aggregate their performance data across the
group's TIN.
(iii) Individual eligible clinicians that elect to participate in
MIPS as a group will have their performance assessed at the group level
across all four MIPS performance categories.
(iv) Groups must adhere to an election process established by CMS,
as applicable.
* * * * *

0
24. Section 414.1315 is revised to read as follows:

Sec. 414.1315 Virtual groups.

(a) Eligibility. (1) For a MIPS payment year, a solo practitioner
or a group of 10 or fewer eligible clinicians may elect to participate
in MIPS as a virtual group with at least one other such solo
practitioner or group. The election must be made prior to the start of
the applicable performance period and cannot be changed during the
performance period. A solo practitioner or group may elect to be in no
more than one virtual group for a performance period, and, in the case
of a group, the election applies to all MIPS eligible clinicians in the
group.
(2) Except as provided under Sec. 414.1370(f)(2), each MIPS
eligible clinician in the virtual group receives a MIPS payment
adjustment factor and, if applicable, an additional MIPS payment
adjustment factor based on the virtual group's combined performance
assessment.
(b) Election deadline. The election deadline is December 31 of the
calendar year preceding the applicable performance period.
(c) Election process. For the 2020 MIPS payment year and future
years, the virtual group election process is as follows:
(1) Stage 1: Virtual group eligibility determination. (i) For the
2020 MIPS payment year, the virtual group eligibility determination
period is an assessment period of up to 5 months beginning on July 1
and ending as late as November 30 of the calendar year preceding the
applicable performance period, and that includes a 30-day claims run
out.
(ii) Beginning with the 2021 MIPS payment year, the virtual group
eligibility determination period is the first segment of the MIPS
determination period.
(2) Stage 2: Virtual group formation. (i) Solo practitioners and
groups that elect to participate in MIPS as a virtual group must
establish a formal written agreement that satisfies paragraph (c)(3) of
this section prior to the election.
(ii) A designated virtual group representative must submit an
election, on behalf of the solo practitioners and groups that compose a
virtual group, to participate in MIPS as a virtual group for a
performance period in a form and manner specified by CMS by the
election deadline specified in paragraph (b) of this section. The
virtual group election must include each TIN and NPI associated with
the virtual group and contact information for the virtual group
representative.
(iii) After an election is made, the virtual group representative
must contact their designated CMS contact to update any election
information that changed during a performance period at least one time
prior to the start of data submission.
(3) Virtual group agreement. The virtual group arrangement must be
set forth in a formal written agreement among the parties, consisting
of each solo practitioner and group that composes a virtual group. The
agreement must comply with the following requirements:
(i) Identifies each party by name, TIN, and each NPI under the TIN,
and includes as parties only the solo practitioners and groups that
compose the virtual group.
(ii) Is for a term of at least one performance period.
(iii) Requires each party to notify each NPI under the party's TIN
regarding their participation in the MIPS as a virtual group.
(iv) Sets forth each NPI's rights and obligations in, and
representation by, the virtual group, including, but not limited to,
the reporting requirements and how participation in the MIPS as a
virtual group affects the NPI's ability to participate in the MIPS
outside of the virtual group.
(v) Describes how the opportunity to receive payment adjustments
will encourage each member of the virtual group (and each NPI under
each TIN in the virtual group) to adhere to quality assurance and
improvement.
(vi) Requires each party to update its Medicare enrollment
information, including the addition or removal of NPIs billing under
its TIN, on a timely basis in accordance with Medicare program
requirements and to notify the other parties of any such changes within
30 days of the change.
(vii) Requires completion of a close-out process upon termination
or expiration of the agreement that requires each party to furnish all
data necessary for the parties to aggregate their data across the
virtual group's TINs.
(viii) Expressly requires each party to participate in the MIPS as
a virtual group and comply with the requirements of the MIPS and all
other applicable laws (including, but not limited to, Federal criminal
law, the Federal False Claims Act, the Federal

[[Page 60078]]

anti-kickback statute, the Federal civil monetary penalties law, the
Federal physician self-referral law, and the Health Insurance
Portability and Accountability Act of 1996).
(ix) Is executed on behalf of each party by an individual who is
authorized to bind the party.
(d) Virtual group reporting requirements. For solo practitioners
and groups of 10 or fewer eligible clinicians to participate in MIPS as
a virtual group, all of the following requirements must be met:
(1) Virtual groups must meet the definition of a virtual group at
all times during the applicable performance period.
(2) Solo practitioners and groups of 10 or fewer eligible
clinicians that elect to participate in MIPS as a virtual group must
aggregate their performance data across the virtual group's TINs.
(3) Solo practitioners and groups of 10 or fewer eligible
clinicians that elect to participate in MIPS as a virtual group will
have their performance assessed at the virtual group level across all
four MIPS performance categories.
(4) Virtual groups must adhere to the election process described in
paragraph (c) of this section.

0
25. Section 414.1320 is amended by revising paragraphs (b)(2) and
(c)(2) and adding paragraphs (d) and (e) to read as follows:

Sec. 414.1320 MIPS performance period.

* * * * *
(b) * * *
(2) Promoting Interoperability and improvement activities
performance categories is a minimum of a continuous 90-day period
within CY 2018, up to and including the full CY 2018 (January 1, 2018
through December 31, 2018).
(c) * * *
(2) Promoting Interoperability and improvement activities
performance categories is a minimum of a continuous 90-day period
within CY 2019, up to and including the full CY 2019 (January 1, 2019
through December 31, 2019).
(d) Beginning with the 2022 MIPS payment year, the performance
period for:
(1) The quality and cost performance categories is the full
calendar year (January 1 through December 31) that occurs 2 years prior
to the applicable MIPS payment year.
(2) The improvement activities performance categories is a minimum
of a continuous 90-day period within the calendar year that occurs 2
years prior to the applicable MIPS payment year, up to and including
the full calendar year.
(e) For purposes of the 2022 MIPS payment year, the performance
period for:
(1) The Promoting Interoperability performance category is a
minimum of a continuous 90-day period within the calendar year that
occurs 2 years prior to the applicable MIPS payment year, up to and
including the full calendar year.
(2) [Reserved]

0
26. Section 414.1325 is revised to read as follows:

Sec. 414.1325 Data submission requirements.

(a) Applicable performance categories. (1) Except as provided in
paragraph (a)(2) of this section or under Sec. 414.1370, as
applicable, individual MIPS eligible clinicians and groups must submit
data on measures and activities for the quality, improvement
activities, and Promoting Interoperability performance categories in
accordance with this section. Except for the Medicare Part B claims
submission type, the data may also be submitted on behalf of the
individual MIPS eligible clinician or group by a third party
intermediary described at Sec. 414.1400.
(2) There are no data submission requirements for:
(i) The cost performance category or administrative claims-based
quality measures. Performance in the cost performance category and on
such measures is calculated by CMS using administrative claims data,
which includes claims submitted with dates of service during the
applicable performance period that are processed no later than 60 days
following the close of the applicable performance period.
(ii) The quality and cost performance categories, as applicable,
for MIPS eligible clinicians and groups that are scored under the
facility-based measurement scoring methodology described in Sec.
414.1380(e).
(b) Data submission types for individual MIPS eligible clinicians.
An individual MIPS eligible clinician may submit their MIPS data using:
(1) For the quality performance category, the direct, login and
upload, and Medicare Part B claims (beginning with the 2021 MIPS
payment year for small practices only) submission types.
(2) For the improvement activities or Promoting Interoperability
performance categories, the direct, login and upload, or login and
attest submission types.
(c) Data submission types for groups. Groups may submit their MIPS
data using:
(1) For the quality performance category, the direct, login and
upload, Medicare Part B claims (beginning with the 2021 MIPS payment
year, for small practices only), and CMS Web Interface (for groups
consisting of 25 or more eligible clinicians or a third party
intermediary submitting on behalf of a group) submission types.
(2) For the improvement activities or Promoting Interoperability
performance categories, the direct, login and upload, or login and
attest submission types.
(d) Use of multiple data submission types. Beginning with the 2021
MIPS payment year, MIPS eligible clinicians, groups, and virtual groups
may submit their MIPS data using multiple data submission types for any
performance category described in paragraph (a)(1) of this section, as
applicable; provided, however, that the MIPS eligible clinician, group,
or virtual group uses the same identifier for all performance
categories and all data submissions.
(e) Data submission deadlines. The data submission deadlines are as
follows:
(1) For the direct, login and upload, login and attest, and CMS Web
Interface submission types, March 31 following the close of the
applicable performance period or a later date as specified by CMS.
(2) For the Medicare Part B claims submission type, data must be
submitted on claims with dates of service during the applicable
performance period that must be processed no later than 60 days
following the close of the applicable performance period.

0
27. Section 414.1330 is revised to read as follows:

Sec. 414.1330 Quality performance category.

(a) For a MIPS payment year, CMS uses the following quality
measures, as applicable, to assess performance in the quality
performance category:
(1) Measures included in the MIPS final list of quality measures
established by CMS through rulemaking;
(2) QCDR measures approved by CMS under Sec. 414.1400;
(3) Facility-based measures described in Sec. 414.1380; and
(4) MIPS APM measures described in Sec. 414.1370.
(b) Unless a different scoring weight is assigned by CMS,
performance in the quality performance category comprises:
(1) 60 percent of a MIPS eligible clinician's final score for MIPS
payment year 2019.
(2) 50 percent of a MIPS eligible clinician's final score for MIPS
payment year 2020.
(3) 45 percent of a MIPS eligible clinician's final score for MIPS
payment year 2021.

[[Page 60079]]

0
28. Section 414.1335 is amended by revising paragraphs (a)(1) through
(3) to read as follows:

Sec. 414.1335 Data submission criteria for the quality performance
category.

(a) * * *
(1) For Medicare Part B claims measures, MIPS CQMs, eCQMs, or QCDR
measures. (i) Except as provided in paragraph (a)(1)(ii) of this
section, submit data on at least six measures, including at least one
outcome measure. If an applicable outcome measure is not available,
report one other high priority measure. If fewer than six measures
apply to the MIPS eligible clinician or group, report on each measure
that is applicable.
(ii) MIPS eligible clinicians and groups that report on a specialty
or subspecialty measure set, as designated in the MIPS final list of
quality measures established by CMS through rulemaking, must submit
data on at least six measures within that set, including at least one
outcome measure. If an applicable outcome measure is not available,
report one other high priority measure. If the set contains fewer than
six measures or if fewer than six measures within the set apply to the
MIPS eligible clinician or group, report on each measure that is
applicable.
(2) For CMS Web Interface measures. (i) Report on all measures
included in the CMS Web Interface. The group is required to report on
at least one measure for which there is Medicare patient data.
(ii) [Reserved]
(3) For the CAHPS for MIPS survey. (i) For the 12-month performance
period, a group that wishes to voluntarily elect to participate in the
CAHPS for MIPS survey must use a survey vendor that is approved by CMS
for the applicable performance period to transmit survey measures data
to CMS.
(ii) [Reserved]
* * * * *

0
29. Section 414.1340 is amended by revising paragraphs (a) introductory
text, (b) introductory text, and (c) to read as follows:

Sec. 414.1340 Data completeness criteria for the quality performance
category.

(a) MIPS eligible clinicians and groups submitting quality measures
data on QCDR measures, MIPS CQMs, or eCQMs must submit data on:
* * * * *
(b) MIPS eligible clinicians and groups submitting quality measure
data on Medicare Part B claims measures must submit data on:
* * * * *
(c) Groups submitting quality measures data on CMS Web Interface
measures or the CAHPS for MIPS survey must submit data on the sample of
the Medicare Part B patients CMS provides, as applicable.
(1) For CMS Web Interface measures. (i) The group must report on
the first 248 consecutively ranked beneficiaries in the sample for each
measure or module. If the sample of eligible assigned beneficiaries is
less than 248, then the group must report on 100 percent of assigned
beneficiaries.
(ii) [Reserved]
(2) [Reserved]

0
30. Section 414.1350 is revised to read as follows:

Sec. 414.1350 Cost performance category.

(a) Specification of cost measures. For purposes of assessing
performance of MIPS eligible clinicians on the cost performance
category, CMS specifies cost measures for a performance period.
(b) Attribution. (1) Cost measures are attributed at the TIN/NPI
level.
(2) For the total per capita cost measure, beneficiaries are
attributed using a method generally consistent with the method of
assignment of beneficiaries under Sec. 425.402 of this chapter.
(3) For the Medicare Spending per Beneficiary (MSPB) measure, an
episode is attributed to the MIPS eligible clinician who submitted the
plurality of claims (as measured by allowed charges) for Medicare Part
B services rendered during an inpatient hospitalization that is an
index admission for the MSPB measure during the applicable performance
period.
(4) For the acute condition episode-based measures specified for
the 2017 performance period, an episode is attributed to each MIPS
eligible clinician who bills at least 30 percent of inpatient
evaluation and management (E&M) visits during the trigger event for the
episode.
(5) For the procedural episode-based measures specified for the
2017 performance period, an episode is attributed to each MIPS eligible
clinician who bills a Medicare Part B claim with a trigger code during
the trigger event for the episode.
(6) For the acute inpatient medical condition episode-based
measures specified beginning with the 2019 performance period, an
episode is attributed to each MIPS eligible clinician who bills
inpatient E&M claim lines during a trigger inpatient hospitalization
under a TIN that renders at least 30 percent of the inpatient E&M claim
lines in that hospitalization.
(7) For the procedural episode-based measures specified beginning
with the 2019 performance period, an episode is attributed to each MIPS
eligible clinician who renders a trigger service as identified by
HCPCS/CPT procedure codes.
(c) Case minimums. (1) For the total per capita cost measure, the
case minimum is 20.
(2) For the Medicare spending per beneficiary measure, the case
minimum is 35.
(3) For the episode-based measures specified for the 2017
performance period, the case minimum is 20.
(4) For the procedural episode-based measures specified beginning
with the 2019 performance period, the case minimum is 10.
(5) For the acute inpatient medical condition episode-based
measures specified beginning with the 2019 performance period, the case
minimum is 20.
(d) Scoring weight. Unless a different scoring weight is assigned
by CMS under section 1848(q)(5)(F) of the Act, performance in the cost
performance category comprises:
(1) Zero percent of a MIPS eligible clinician's final score for
MIPS payment year 2019.
(2) 10 percent of a MIPS eligible clinician's final score for MIPS
payment year 2020.
(3) 15 percent of a MIPS eligible clinician's final score for MIPS
payment year 2021.

0
31. Section 414.1355 is amended by revising paragraphs (a), (b)
introductory text, and (c) to read as follows:

Sec. 414.1355 Improvement activities performance category.

(a) For a MIPS payment year, CMS uses improvement activities
included in the MIPS final inventory of improvement activities
established by CMS through rulemaking to assess performance in the
improvement activities performance category.
(b) Unless a different scoring weight is assigned by CMS under
section 1848(q)(5)(F) of the Act, performance in the improvement
activities performance category comprises:
* * * * *
(c) The following are the list of subcategories, of which, with the
exception of Participation in an APM, include activities for selection
by a MIPS eligible clinician or group:
(1) Expanded practice access, such as same day appointments for
urgent needs and after-hours access to clinician advice.
(2) Population management, such as monitoring health conditions of

[[Page 60080]]

individuals to provide timely health care interventions or
participation in a QCDR.
(3) Care coordination, such as timely communication of test
results, timely exchange of clinical information to patients or other
clinicians, and use of remote monitoring or telehealth.
(4) Beneficiary engagement, such as the establishment of care plans
for individuals with complex care needs, beneficiary self-management
assessment and training, and using shared decision making mechanisms.
(5) Patient safety and practice assessment, such as through the use
of clinical or surgical checklists and practice assessments related to
maintaining certification.
(6) Participation in an APM.
(7) Achieving health equity, such as for MIPS eligible clinicians
that achieve high quality for underserved populations, including
persons with behavioral health conditions, racial and ethnic
minorities, sexual and gender minorities, people with disabilities,
people living in rural areas, and people in geographic HPSAs.
(8) Emergency preparedness and response, such as measuring MIPS
eligible clinician participation in the Medical Reserve Corps,
measuring registration in the Emergency System for Advance Registration
of Volunteer Health Professionals, measuring relevant reserve and
active duty uniformed services MIPS eligible clinician activities, and
measuring MIPS eligible clinician volunteer participation in domestic
or international humanitarian medical relief work.
(9) Integrated behavioral and mental health, such as measuring or
evaluating such practices as: Co-location of behavioral health and
primary care services; shared/integrated behavioral health and primary
care records; cross training of MIPS eligible clinicians, and
integrating behavioral health with primary care to address substance
use disorders or other behavioral health conditions, as well as
integrating mental health with primary care.

0
32. Section 414.1360 is amended by revising paragraph (a)(1) to read as
follows:

Sec. 414.1360 Data submission criteria for the improvement
activities performance category.

(a) * * *
(1) Via direct, login and upload, and login and attest. For the
applicable performance period, submit a yes response for each
improvement activity that is performed for at least a continuous 90-day
period during the applicable performance period.
* * * * *

Sec. 414.1365 [Removed]

0
33. Section 414.1365 is removed.

0
34. Section 414.1370 is amended by revising paragraphs (b)(3), (f)(2),
(g)(4), (h)(4) introductory heading, (h)(5)(i)(A) and (B), and
(h)(5)(ii) introductory text.
The revisions read as follows:

Sec. 414.1370 APM scoring standard under MIPS.

* * * * *
(b) * * *
(3) The APM bases payment on quality measures and cost/utilization;
and
* * * * *
(f) * * *
(2) MIPS eligible clinicians who participate in a group or have
elected to participate in a virtual group and who are also on a MIPS
APM Participation List will be included in the assessment under MIPS
for purposes of producing a group or virtual group score and under the
APM scoring standard for purposes of producing an APM Entity score. The
MIPS payment adjustment for these eligible clinicians is based solely
on their APM Entity score; if the APM Entity group is exempt from MIPS
all eligible clinicians within that APM Entity group are also exempt
from MIPS.
(g) * * *
(4) Promoting Interoperability. (i) For the 2019 and 2020 MIPS
payment years, each Shared Savings Program ACO participant TIN must
report data on the Promoting Interoperability performance category
separately from the ACO, as specified in Sec. 414.1375(b)(2). The ACO
participant TIN scores are weighted according to the number of MIPS
eligible clinicians in each TIN as a proportion of the total number of
MIPS eligible clinicians in the APM Entity group, and then aggregated
to determine an APM Entity score for the ACI performance category.
(ii) For the 2019 and 2020 MIPS payment years, for APM Entities in
MIPS APMs other than the Shared Savings Program, CMS uses one score for
each MIPS eligible clinician in the APM Entity group to derive a single
average APM Entity score for the Promoting Interoperability performance
category. Beginning with the 2021 MIPS payment year, for APM Entities
in MIPS APMs including the Shared Savings Program, CMS uses one score
for each MIPS eligible clinician in the APM Entity group to derive a
single average APM Entity score for the Promoting Interoperability
performance category. The score for each MIPS eligible clinician is the
higher of either:
(A) A group score based on the measure data for the Promoting
Interoperability performance category reported by a TIN for the MIPS
eligible clinician according to MIPS submission and reporting
requirements for groups; or
(B) An individual score based on the measure data for the Promoting
Interoperability performance category reported by the MIPS eligible
clinician according to MIPS submission and reporting requirements for
individuals.
(iii) In the event that a MIPS eligible clinician participating in
a MIPS APM receives an exception from the Promoting Interoperability
performance category reporting requirements, such eligible clinician
will be assigned a null score when CMS calculates the APM Entity's
Promoting Interoperability performance category score under the APM
scoring standard.
(A) If all MIPS eligible clinicians in an APM Entity have been
excepted from reporting the Promoting Interoperability performance
category, the performance category weight will be reweighted to zero
for the APM Entity for that MIPS performance period.
(B) [Reserved]
(h) * * *
(4) Promoting Interoperability. * * *
(5) * * *
(i) * * *
(A) In 2017, the improvement activities performance category is
reweighted to 25 percent and the Promoting Interoperability performance
category is reweighted to 75 percent; and
(B) Beginning in 2018, the Promoting Interoperability performance
category is reweighted to 75 percent and the improvement activities
performance category is reweighted to 25 percent.
(ii) If CMS reweights the Promoting Interoperability performance
category to zero percent:
* * * * *

0
35. Section 414.1375 is amended by revising the section heading,
paragraphs (a), (b) introductory text, and (b)(2) to read as follows:

Sec. 414.1375 Promoting Interoperability (PI) performance category.

(a) Final score. Unless a different scoring weight is assigned by
CMS under sections 1848(o)(2)(D), 1848(q)(5)(E)(ii), or 1848(q)(5)(F)
of the Act, performance in the Promoting Interoperability performance
category comprises 25 percent of a MIPS eligible clinician's final
score for each MIPS payment year.

[[Page 60081]]

(b) Reporting for the Promoting Interoperability performance
category. To earn a performance category score for the Promoting
Interoperability performance category for inclusion in the final score,
a MIPS eligible clinician must:
* * * * *
(2) Report MIPS--Promoting Interoperability objectives and
measures. Report on the objectives and associated measures as specified
by CMS for the Promoting Interoperability performance category for the
performance period as follows:
(i) For the 2019 and 2020 MIPS payment years: For each base score
measure, as applicable, report the numerator (of at least one) and
denominator, or yes/no statement, or claim an exclusion for each
measure that includes an option for an exclusion; and
(ii) For the 2021 and 2022 MIPS payment years:
(A) Report that the MIPS eligible clinician completed the actions
included in the Security Risk Analysis measure during the year in which
the performance period occurs; and
(B) For each required measure, as applicable, report the numerator
(of at least one) and denominator, or yes/no statement, or an exclusion
for each measure that includes an option for an exclusion.
* * * * *

0
36. Section 414.1380 is revised to read as follows:

Sec. 414.1380 Scoring.

(a) General. MIPS eligible clinicians are scored under MIPS based
on their performance on measures and activities in four performance
categories. MIPS eligible clinicians are scored against performance
standards for each performance category and receive a final score,
composed of their performance category scores, and calculated according
to the final score methodology.
(1) Performance standards. (i) For the quality performance
category, measures are scored between zero and 10 measure achievement
points. Performance is measured against benchmarks. Measure bonus
points are available for submitting high-priority measures, submitting
measures using end-to-end electronic reporting, and in small practices
that submit data on at least 1 quality measure. Beginning with the 2020
MIPS payment year, improvement scoring is available in the quality
performance category.
(ii) For the cost performance category, measures are scored between
1 and 10 points. Performance is measured against a benchmark. Starting
with the 2024 MIPS payment year, improvement scoring is available in
the cost performance category.
(iii) For the improvement activities performance category, each
improvement activity is assigned a certain number of points. The points
for all submitted activities are summed and scored against a total
potential performance category score of 40 points.
(iv) For the Promoting Interoperability performance category, each
measure is scored against a maximum number of points. The points for
all submitted measures are summed and scored against a total potential
performance category score of 100 points.
(2) [Reserved]
(b) Performance categories. MIPS eligible clinicians are scored
under MIPS in four performance categories.
(1) Quality performance category. (i) Measure achievement points.
For the 2019, 2020, and 2021 MIPS payment years, MIPS eligible
clinicians receive between 3 and 10 measure achievement points
(including partial points) for each measure required under Sec.
414.1335 on which data is submitted in accordance with Sec. 414.1325
that has a benchmark at paragraph (b)(1)(ii) of this section, meets the
case minimum requirement at paragraph (b)(1)(iii) of this section, and
meets the data completeness requirement at Sec. 414.1340. The number
of measure achievement points received for each such measure is
determined based on the applicable benchmark decile category and the
percentile distribution. MIPS eligible clinicians receive zero measure
achievement points for each measure required under Sec. 414.1335 on
which no data is submitted in accordance with Sec. 414.1325. MIPS
eligible clinicians that submit data in accordance with Sec. 414.1325
on a greater number of measures than required under Sec. 414.1335 are
scored only on the required measures with the greatest number of
measure achievement points. Beginning with the 2021 MIPS payment year,
MIPS eligible clinicians that submit data in accordance with Sec.
414.1325 on a single measure via multiple collection types are scored
only on the data submission with the greatest number of measure
achievement points.
(A) Lack of benchmark or case minimum. (1) Except as provided in
paragraph (b)(1)(i)(A)(2) of this section, for the 2019, 2020, and 2021
MIPS payment years, MIPS eligible clinicians receive 3 measure
achievement points for each submitted measure that meets the data
completeness requirement, but does not have a benchmark or meet the
case minimum requirement.
(2) The following measures are excluded from a MIPS eligible
clinician's total measure achievement points and total available
measure achievement points:
(i) Each submitted CMS Web Interface-based measure that meets the
data completeness requirement, but does not have a benchmark or meet
the case minimum requirement, or is redesignated as pay-for-reporting
for all Shared Savings Program accountable care organizations by the
Shared Savings Program; and
(ii) Each administrative claims-based measure that does not have a
benchmark or meet the case minimum requirement.
(B) Lack of complete data. (1) Except as provided in paragraph
(b)(1)(i)(B)(2) of this section, for each submitted measure that does
not meet the data completeness requirement:
(i) For the 2019 MIPS payment year, MIPS eligible clinicians
receive 3 measure achievement points;
(ii) For the 2020 and 2021 MIPS payment years, MIPS eligible
clinicians other than small practices receive 1 measure achievement
point, and small practices receive 3 measure achievement points; and
(iii) Beginning with the 2022 MIPS payment year, MIPS eligible
clinicians other than small practices receive zero measure achievement
points, and small practices receive 3 measure achievement points.
(2) MIPS eligible clinicians receive zero measure achievement
points for each submitted CMS Web Interface-based measure that does not
meet the data completeness requirement.
(ii) Benchmarks. Benchmarks will be based on collection type, from
all available sources, including MIPS eligible clinicians and APMs, to
the extent feasible, during the applicable baseline or performance
period.
(A) Each benchmark must have a minimum of 20 individual clinicians
or groups who reported the measure meeting the case minimum requirement
at paragraph (b)(1)(iii) of this section and the data completeness
requirement at Sec. 414.1340 and having a performance rate that is
greater than zero.
(B) CMS Web Interface collection type uses benchmarks from the
corresponding reporting year of the Shared Savings Program.
(iii) Minimum case requirements. Except for the all-cause hospital
readmission measure, the minimum case requirement is 20 cases. For the
all-cause hospital readmission measure, the minimum case requirement is
200 cases.

[[Page 60082]]

(iv) Topped out measures. CMS will identify topped out measures in
the benchmarks published for each Quality Payment Program year.
(A) For the 2020 MIPS payment year, each topped out measure
specified by CMS through rulemaking receives no more than 7 measure
achievement points, provided that the benchmark for the applicable
collection type is identified as topped out in the benchmarks published
for the 2018 MIPS performance period.
(B) Beginning with the 2021 MIPS payment year, each measure (except
for measures in the CMS Web Interface) for which the benchmark for the
applicable collection type is identified as topped out for 2 or more
consecutive years receives no more than 7 measure achievement points in
the second consecutive year it is identified as topped out, and beyond.
(v) Measure bonus points. MIPS eligible clinicians receive measure
bonus points for the following measures, except as otherwise required
under Sec. 414.1335, regardless of whether the measure is included in
the MIPS eligible clinician's total measure achievement points.
(A) High priority measures. Subject to paragraph (b)(1)(v)(A)(1) of
this section, MIPS eligible clinicians receive 2 measure bonus points
for each outcome and patient experience measure and 1 measure bonus
point for each other high priority measure. Beginning with the 2021
MIPS payment year, MIPS eligible clinicians do not receive such measure
bonus points for CMS Web Interface measures.
(1) Limitations. (i) Each high priority measure must have a
benchmark at paragraph (b)(1)(ii) of this section, meet the case
minimum requirement at (b)(1)(iii) of this section, meet the data
completeness requirement at Sec. 414.1340, and have a performance rate
that is greater than zero.
(ii) For the 2019, 2020, and 2021 MIPS payment years, the total
measure bonus points for high priority measures cannot exceed 10
percent of the total available measure achievement points.
(iii) Beginning with the 2021 MIPS payment year, MIPS eligible
clinicians that collect data in accordance with Sec. 414.1325 on a
single measure via multiple collection types receive measure bonus
points only once.
(B) End-to-end electronic reporting. Subject to paragraph
(b)(1)(v)(B)(1) of this section, MIPS eligible clinicians receive 1
measure bonus point for each measure (except claims-based measures)
submitted with end-to-end electronic reporting for a quality measure
under certain criteria determined by the Secretary.
(1) Limitations. (i) For the 2019, 2020, and 2021 MIPS payment
years, the total measure bonus points for measures submitted with end-
to-end electronic reporting cannot exceed 10 percent of the total
available measure achievement points.
(ii) Beginning with the 2021 MIPS payment year, MIPS eligible
clinicians that collect data in accordance with Sec. 414.1325 on a
single measure via multiple collection types receive measure bonus
points only once.
(C) Small practices. Beginning with the 2021 MIPS payment year,
MIPS eligible clinicians in small practices receive 6 measure bonus
points if they submit data to MIPS on at least 1 quality measure.
(vi) Improvement scoring. Improvement scoring is available to MIPS
eligible clinicians that demonstrate improvement in performance in the
current MIPS performance period compared to performance in the
performance period immediately prior to the current MIPS performance
period based on measure achievement points.
(A) Improvement scoring is available when the data sufficiency
standard is met, which means when data are available and a MIPS
eligible clinician has a quality performance category achievement
percent score for the previous performance period and the current
performance period.
(1) Data must be comparable to meet the requirement of data
sufficiency which means that the quality performance category
achievement percent score is available for the current performance
period and the previous performance period and quality performance
category achievement percent scores can be compared.
(2) Quality performance category achievement percent scores are
comparable when submissions are received from the same identifier for
two consecutive performance periods.
(3) If the identifier is not the same for 2 consecutive performance
periods, then for individual submissions, the comparable quality
performance category achievement percent score is the highest available
quality performance category achievement percent score associated with
the final score from the prior performance period that will be used for
payment for the individual. For group, virtual group, and APM Entity
submissions, the comparable quality performance category achievement
percent score is the average of the quality performance category
achievement percent score associated with the final score from the
prior performance period that will be used for payment for each of the
individuals in the group.
(4) Improvement scoring is not available for clinicians who were
scored under facility-based measurement in the performance period
immediately prior to the current MIPS performance period.
(B) The improvement percent score may not total more than 10
percentage points.
(C) The improvement percent score is assessed at the performance
category level for the quality performance category and included in the
calculation of the quality performance category percent score as
described in paragraph (b)(1)(vii) of this section.
(1) The improvement percent score is awarded based on the rate of
increase in the quality performance category achievement percent score
of MIPS eligible clinicians from the previous performance period to the
current performance period.
(2) An improvement percent score is calculated by dividing the
increase in the quality performance category achievement percent score
from the prior performance period to the current performance period by
the prior performance period quality performance category achievement
percent score multiplied by 10 percent.
(3) An improvement percent score cannot be lower than zero
percentage points.
(4) For the 2020 and 2021 MIPS payment year, we will assume a
quality performance category achievement percent score of 30 percent if
a MIPS eligible clinician earned a quality performance category score
less than or equal to 30 percent in the previous year.
(5) The improvement percent score is zero if the MIPS eligible
clinician did not fully participate in the quality performance category
for the current performance period.
(D) For the purpose of improvement scoring methodology, the term
``quality performance category achievement percent score'' means the
total measure achievement points divided by the total available measure
achievement points, without consideration of measure bonus points or
improvement percent score.
(E) For the purpose of improvement scoring methodology, the term
``improvement percent score'' means the score that represents
improvement for the purposes of calculating the quality performance
category percent score as described in paragraph (b)(1)(vii) of this
section.
(F) For the purpose of improvement scoring methodology, the term
``fully participate'' means the MIPS eligible

[[Page 60083]]

clinician met all requirements in Sec. Sec. 414.1335 and 414.1340.
(vii) Quality performance category score. A MIPS eligible
clinician's quality performance category percent score is the sum of
all the measure achievement points assigned for the measures required
for the quality performance category criteria plus the measure bonus
points in paragraph (b)(1)(v) of this section. The sum is divided by
the sum of total available measure achievement points. The improvement
percent score in paragraph (b)(1)(vi) of this section is added to that
result. The quality performance category percent score cannot exceed
100 percentage points.
(A) Beginning with the 2021 MIPS payment year, for each measure
that a MIPS eligible clinician submits that is significantly impacted
by clinical guideline changes or other changes that CMS believes may
result in patient harm or misleading results, the total available
measure achievement points are reduced by 10 points.
(B) Beginning with the 2021 MIPS payment year, for groups that
submit 5 or fewer measures and register for the CAHPS for MIPS survey
but do not meet the minimum beneficiary sampling requirements, the
total available measure achievement points are reduced by 10 points.
(viii) ICD-10 updates. Beginning with the 2018 MIPS performance
period, measures significantly impacted by ICD-10 updates, as
determined by CMS, will be assessed based only on the first 9 months of
the 12-month performance period. For purposes of this paragraph
(b)(1)(viii), CMS will make a determination as to whether a measure is
significantly impacted by ICD-10 coding changes during the performance
period. CMS will publish on the CMS website which measures require a 9-
month assessment process by October 1st of the performance period if
technically feasible, but by no later than the beginning of the data
submission period at Sec. 414.1325(f)(1).
(2) Cost performance category. For each cost measure attributed to
a MIPS eligible clinician, the clinician receives one to ten
achievement points based on the clinician's performance on the measure
during the performance period compared to the measure's benchmark.
Achievement points are awarded based on which benchmark decile range
the MIPS eligible clinician's performance on the measure is between.
CMS assigns partial points based on the percentile distribution.
(i) Cost measure benchmarks are determined by CMS based on cost
measure performance during the performance period. At least 20 MIPS
eligible clinicians or groups must meet the minimum case volume
specified under Sec. 414.1350(c) for a cost measure in order for a
benchmark to be determined for the measure. If a benchmark is not
determined for a cost measure, the measure will not be scored.
(ii) A MIPS eligible clinician must meet the minimum case volume
specified under Sec. 414.1350(c) to be scored on a cost measure.
(iii) The cost performance category percent score is the sum of the
following, not to exceed 100 percent:
(A) The total number of achievement points earned by the MIPS
eligible clinician divided by the total number of available achievement
points; and
(B) The cost improvement score, as determined under paragraph
(b)(2)(iv) of this section.
(iv) The cost improvement score is determined for a MIPS eligible
clinician that demonstrates improvement in performance in the current
MIPS performance period compared to their performance in the
immediately preceding MIPS performance period.
(A) The cost improvement score is determined at the measure level
for the cost performance category.
(B) The cost improvement score is calculated only when data
sufficient to measure improvement is available. Sufficient data is
available when a MIPS eligible clinician or group participates in MIPS
using the same identifier in 2 consecutive performance periods and is
scored on the same cost measure(s) for 2 consecutive performance
periods. If the cost improvement score cannot be calculated because
sufficient data is not available, then the cost improvement score is
zero.
(C) The cost improvement score is determined by comparing the
number of measures with a statistically significant change (improvement
or decline) in performance; a change is determined to be significant
based on application of a t-test. The number of cost measures with a
significant decline is subtracted from the number of cost measures with
a significant improvement, with the result divided by the number of
cost measures for which the MIPS eligible clinician or group was scored
for 2 consecutive performance periods. The resulting fraction is then
multiplied by the maximum cost improvement score.
(D) The cost improvement score cannot be lower than zero percentage
points.
(E) The maximum cost improvement score for the 2020, 2021, 2022,
and 2023 MIPS payment years is zero percentage points.
(v) A cost performance category percent score is not calculated if
a MIPS eligible clinician or group is not attributed any cost measures
for the performance period because the clinician or group has not met
the minimum case volume specified by CMS for any of the cost measures
or a benchmark has not been created for any of the cost measures that
would otherwise be attributed to the clinician or group.
(3) Improvement activities performance category. Subject to
paragraphs (b)(3)(i) and (ii) of this section, the improvement
activities performance category score equals the total points for all
submitted improvement activities divided by 40 points, multiplied by
100 percent. MIPS eligible clinicians (except for non-patient facing
MIPS eligible clinicians, small practices, and practices located in
rural areas and geographic HPSAs) receive 10 points for each medium-
weighted improvement activity and 20 points for each high-weighted
improvement activity required under Sec. 414.1360 on which data is
submitted in accordance with Sec. 414.1325. Non-patient facing MIPS
eligible clinicians, small practices, and practices located in rural
areas and geographic HPSAs receive 20 points for each medium-weighted
improvement activity and 40 points for each high-weighted improvement
activity required under Sec. 414.1360 on which data is submitted in
accordance with Sec. 414.1325.
(i) For MIPS eligible clinicians participating in APMs, the
improvement activities performance category score is at least 50
percent.
(ii) For MIPS eligible clinicians in a practice that is certified
or recognized as a patient-centered medical home or comparable
specialty practice, as determined by the Secretary, the improvement
activities performance category score is 100 percent. For the 2019 MIPS
payment year, at least one practice site within a group's TIN must be
certified or recognized as a patient-centered medical home or
comparable specialty practice. For the 2020 MIPS payment year and
future years, at least 50 percent of the practice sites within a
group's TIN must be recognized as a patient-centered medical home or
comparable specialty practice. MIPS eligible clinicians that wish to
claim this status for purposes of receiving full credit in the
improvement activities performance category must attest to their status
as a patient-centered medical home or comparable specialty practice in
order to receive this credit. A practice is certified or recognized as

[[Page 60084]]

a patient-centered medical home if it meets any of the following
criteria:
(A) The practice has received accreditation from one of four
accreditation organizations that are nationally recognized;
(1) The Accreditation Association for Ambulatory Health Care;
(2) The National Committee for Quality Assurance (NCQA);
(3) The Joint Commission; or
(4) The Utilization Review Accreditation Commission (URAC).
(B) The practice is participating in a Medicaid Medical Home Model
or Medical Home Model.
(C) The practice is a comparable specialty practice that has
received the NCQA Patient-Centered Specialty Recognition.
(D) The practice has received accreditation from other certifying
bodies that have certified a large number of medical organizations and
meet national guidelines, as determined by the Secretary. The Secretary
must determine that these certifying bodies must have 500 or more
certified member practices, and require practices to include the
following:
(1) Have a personal physician/clinician in a team-based practice.
(2) Have a whole-person orientation.
(3) Provide coordination or integrated care.
(4) Focus on quality and safety.
(5) Provide enhanced access.
(4) Promoting Interoperability performance category. (i) For the
2019 and 2020 MIPS payment years, a MIPS eligible clinician's Promoting
Interoperability performance category score equals the sum of the base
score, performance score, and any applicable bonus scores, not to
exceed 100 percentage points. A MIPS eligible clinician cannot earn a
performance score or bonus score unless they have earned a base score.
(A) A MIPS eligible clinician earns a base score by reporting for
each base score measure, as applicable: The numerator (of at least one)
and denominator, or a yes/no statement, or an exclusion.
(B) A MIPS eligible clinician earns a performance score by
reporting on the performance score measures specified by CMS. A MIPS
eligible clinician may earn up to 10 or 20 percentage points as
specified by CMS for each performance score measure reported.
(C) A MIPS eligible clinician may earn the following bonus scores:
(1) A bonus score of 5 percentage points for reporting to one or
more additional public health agencies or clinical data registries.
(2) A bonus score of 10 percentage points for attesting to
completing one or more improvement activities specified by CMS using
CEHRT.
(3) For the 2020 MIPS payment year, a bonus score of 10 percentage
points for submitting data for the measures for the base score and the
performance score generated solely from CEHRT as defined in Sec.
414.1305 for 2019 and subsequent years.
(ii) For the 2021 and 2022 MIPS payment years, a MIPS eligible
clinician's Promoting Interoperability performance category score
equals the sum of the scores for each of the six required measures and
any applicable bonus scores, not to exceed 100 points.
(A) A MIPS eligible clinician earns a score for each measure by
reporting, as applicable: the numerator (of at least one) and
denominator, or a yes/no statement. If an exclusion is reported for a
measure, the points available for that measure are redistributed to
another measure(s).
(B) Each required measure is worth 10, 20, or 40 points, as
specified by CMS.
(C) Each optional measure is worth five bonus points.
(c) Final score calculation. Each MIPS eligible clinician receives
a final score of 0 to 100 points for a performance period for a MIPS
payment year calculated as follows. If a MIPS eligible clinician is
scored on fewer than 2 performance categories, he or she receives a
final score equal to the performance threshold.

------------------------------------------------------------------------

-------------------------------------------------------------------------
For the 2019 MIPS payment year:
Final score = [(quality performance category percent score x quality
performance category weight) + (cost performance category percent
score x cost performance category weight) + (improvement activities
performance category score x improvement activities performance
category weight) + (Promoting Interoperability performance category
score x Promoting Interoperability performance category weight)],
not to exceed 100 points.
For the 2020 MIPS payment year:
Final score = [(quality performance category percent score x quality
performance category weight) + (cost performance category percent
score x cost performance category weight) + (improvement activities
performance category score x improvement activities performance
category weight) + (Promoting Interoperability performance category
score x Promoting Interoperability performance category weight)] x
100 + [the complex patient bonus + the small practice bonus], not
to exceed 100 points.
Beginning with the 2021 MIPS payment year:
Final score = [(quality performance category percent score x quality
performance category weight) + (cost performance category percent
score x cost performance category weight) + (improvement activities
performance category score x improvement activities performance
category weight) + (Promoting Interoperability performance category
score x Promoting Interoperability performance category weight)] x
100 + the complex patient bonus, not to exceed 100 points.
------------------------------------------------------------------------

(1) Performance category weights. The weights of the performance
categories in the final score are as follows, unless a different
scoring weight is assigned under paragraph (c)(2) of this section:
(i) Quality performance category weight is defined under Sec.
414.1330(b).
(ii) Cost performance category weight is defined under Sec.
414.1350(d).
(iii) Improvement activities performance category weight is defined
under Sec. 414.1355(b).
(iv) Promoting Interoperability performance category weight is
defined under Sec. 414.1375(a).
(2) Reweighting the performance categories. (i) In accordance with
paragraph (c)(2)(ii) of this section, a scoring weight different from
the weights specified in paragraph (c)(1) of this section will be
assigned to a performance category, and its weight as specified in
paragraph (c)(1) of this section will be redistributed to another
performance category or categories, in the following circumstances:
(A) CMS determines based on the following circumstances that there
are not sufficient measures and activities applicable and available
under section 1848(q)(5)(F) of the Act.
(1) For the quality performance category, CMS cannot calculate a
score for the MIPS eligible clinician because there is not at least one
quality measure applicable and available to the clinician.
(2) For the cost performance category, CMS cannot reliably
calculate a score for the cost measures that adequately captures and
reflects the performance of the MIPS eligible clinician.
(3) Beginning with the 2021 MIPS payment year, for the quality,
cost, improvement activities, and Promoting

[[Page 60085]]

Interoperability performance categories, the MIPS eligible clinician
joins an existing practice during the final 3 months of the performance
period year that is not participating in MIPS as a group or joins a
practice that is newly formed during the final 3 months of the
performance period year.
(4) For the Promoting Interoperability performance category
beginning with the 2021 MIPS payment year, the MIPS eligible clinician
is a physical therapist, occupational therapist, clinical psychologist,
qualified audiologist, qualified speech-language pathologist, or a
registered dietitian or nutrition professional. In the event that a
MIPS eligible clinician submits data for the Promoting Interoperability
performance category, the scoring weight specified in paragraph (c)(1)
of this section will be applied and its weight will not be
redistributed.
(5) For the Promoting Interoperability performance category for the
2019, 2020, and 2021 MIPS payment years, the MIPS eligible clinician is
a nurse practitioner, physician assistant, clinical nurse specialist,
or certified registered nurse anesthetist. In the event that a MIPS
eligible clinician submits data for the Promoting Interoperability
performance category, the scoring weight specified in paragraph (c)(1)
of this section will be applied and its weight will not be
redistributed.
(6) Beginning with the 2020 MIPS payment year, for the quality,
cost, and improvement activities performance categories, the MIPS
eligible clinician demonstrates through an application submitted to CMS
that they were subject to extreme and uncontrollable circumstances that
prevented the clinician from collecting information that the clinician
would submit for a performance category or submitting information that
would be used to score a performance category for an extended period of
time. Beginning with the 2021 MIPS payment year, in the event that a
MIPS eligible clinician submits data for the quality, cost, or
improvement activities performance categories, the scoring weight
specified in paragraph (c)(1) of this section will be applied and its
weight will not be redistributed.
(7) For the 2019 MIPS payment year, for the quality and improvement
activities performance categories, the MIPS eligible clinician was
located in an area affected by extreme and uncontrollable circumstances
as identified by CMS. In the event that a MIPS eligible clinician
submits data for a performance category, the scoring weight specified
in paragraph (c)(1) of this section will be applied and its weight will
not be redistributed.
(8) Beginning with the 2020 MIPS payment year, for the quality,
cost, and improvement activities performance categories, the MIPS
eligible clinician was located in an area affected by extreme and
uncontrollable circumstances as identified by CMS. In the event that a
MIPS eligible clinician submits data for the quality or improvement
activities performance categories, the scoring weight specified in
paragraph (c)(1) of this section will be applied and its weight will
not be redistributed.
(B) Under section 1848(q)(5)(E)(ii) of the Act, CMS estimates that
the proportion of MIPS eligible clinicians who are physicians as
defined in section 1861(r) of the Act and earn a Promoting
Interoperability performance category score of at least 75 percent is
75 percent or greater. The estimation is based on data from the
performance period that occurs four years before the MIPS payment year
and does not include physicians for whom the Promoting Interoperability
performance category is weighted at zero percent.
(C) Under section 1848(o)(2)(D) of the Act, a significant hardship
exception or other type of exception is granted to a MIPS eligible
clinician based on the following circumstances for the Promoting
Interoperability performance category. In the event that a MIPS
eligible clinician submits data for the Promoting Interoperability
performance category, the scoring weight specified in paragraph (c)(1)
of this section will be applied and its weight will not be
redistributed.
(1) The MIPS eligible clinician demonstrates through an application
submitted to CMS that they lacked sufficient internet access during the
performance period, and insurmountable barriers prevented the clinician
from obtaining sufficient internet access.
(2) The MIPS eligible clinician demonstrates through an application
submitted to CMS that they were subject to extreme and uncontrollable
circumstances that caused their CEHRT to be unavailable.
(3) The MIPS eligible clinician was located in an area affected by
extreme and uncontrollable circumstances as identified by CMS.
(4) The MIPS eligible clinician demonstrates through an application
submitted to CMS that 50 percent or more of their outpatient encounters
occurred in practice locations where they had no control over the
availability of CEHRT.
(5) The MIPS eligible clinician is a non-patient facing MIPS
eligible clinician as defined in Sec. 414.1305.
(6) The MIPS eligible clinician is a hospital-based MIPS eligible
clinician as defined in Sec. 414.1305.
(7) The MIPS eligible clinician is an ASC-based MIPS eligible
clinician as defined in Sec. 414.1305.
(8) Beginning with the 2020 MIPS payment year, the MIPS eligible
clinician demonstrates through an application submitted to CMS that
their CEHRT was decertified either during the performance period for
the MIPS payment year or during the calendar year preceding the
performance period for the MIPS payment year, and the MIPS eligible
clinician made a good faith effort to adopt and implement another CEHRT
in advance of the performance period. In no case may a MIPS eligible
clinician be granted this exception for more than 5 years.
(9) Beginning with the 2020 MIPS payment year, the MIPS eligible
clinician demonstrates through an application submitted to CMS that
they are in a small practice as defined in Sec. 414.1305, and
overwhelming barriers prevent them from complying with the requirements
for the Promoting Interoperability performance category.
(ii) A scoring weight different from the weights specified in
paragraph (c)(1) of this section will be assigned to a performance
category, and its weight as specified in paragraph (c)(1) of this
section will be redistributed to another performance category or
categories, as follows:
(A) For the 2019 MIPS payment year:

----------------------------------------------------------------------------------------------------------------
Reweight Reweight Reweight
scenario if no scenario if no scenario if no
Weighting for promoting quality improvement
Performance category (%) the 2019 MIPS interoperability performance activities
payment year performance category performance
(%) category score percent score category score
(%) (%) (%)
----------------------------------------------------------------------------------------------------------------
Quality....................................... 60 85 0 75
Cost.......................................... 0 0 0 0
Improvement Activities........................ 15 15 50 0

[[Page 60086]]

Promoting Interoperability.................... 25 0 50 25
----------------------------------------------------------------------------------------------------------------

(B) For the 2020 MIPS payment year:

----------------------------------------------------------------------------------------------------------------
Promoting
Reweighting scenario Quality (%) Cost (%) Improvement interoperability
activities (%) (%)
----------------------------------------------------------------------------------------------------------------
No Reweighting Needed:
--Scores for all four performance 50 10 15 25
categories...............................
Reweight One Performance Category:
--No Cost................................. 60 0 15 25
--No Promoting Interoperability........... 75 10 15 0
--No Quality.............................. 0 10 45 45
--No Improvement Activities............... 65 10 0 25
Reweight Two Performance Categories:
--No Cost and no Promoting 85 0 15 0
Interoperability.........................
--No Cost and no Quality.................. 0 0 50 50
--No Cost and no Improvement Activities... 75 0 0 25
--No Promoting Interoperability and no 0 10 90 0
Quality..................................
--No Promoting Interoperability and no 90 10 0 0
Improvement Activities...................
--No Quality and no Improvement Activities 0 10 0 90
----------------------------------------------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------
Promoting
Reweighting scenario Quality (%) Cost (%) Improvement interoperability
activities (%) (%)
----------------------------------------------------------------------------------------------------------------
No Reweighting Needed:
--Scores for all four performance 45 15 15 25
categories...............................
Reweight One Performance Category:
--No Cost................................. 60 0 15 25
--No Promoting Interoperability........... 70 15 15 0
--No Quality.............................. 0 15 40 45
--No Improvement Activities............... 60 15 0 25
Reweight Two Performance Categories:
--No Cost and no Promoting 85 0 15 0
Interoperability.........................
--No Cost and no Quality.................. 0 0 50 50
--No Cost and no Improvement Activities... 75 0 0 25
--No Promoting Interoperability and no 0 15 85 0
Quality..................................
--No Promoting Interoperability and no 85 15 0 0
Improvement Activities...................
--No Quality and no Improvement Activities 0 15 0 85
----------------------------------------------------------------------------------------------------------------

(iii) For MIPS eligible clinicians submitting data as a group or
virtual group, in order for the Promoting Interoperability performance
category to be reweighted in accordance with paragraph (c)(2)(ii) of
this section, all of the MIPS eligible clinicians in the group must
qualify for reweighting based on the circumstances described in
paragraph (c)(2)(i) of this section.
(3) Complex patient bonus. For the 2020 and 2021 MIPS payment
years, provided that a MIPS eligible clinician, group, virtual group or
APM entity submits data for at least one MIPS performance category for
the applicable performance period for the MIPS payment year, a complex
patient bonus will be added to the final score for the MIPS payment
year, as follows:
(i) For MIPS eligible clinicians and groups, the complex patient
bonus is calculated as follows: [The average HCC risk score assigned to
beneficiaries (pursuant to the HCC risk adjustment model established by
CMS pursuant to section 1853(a)(1) of the Act) seen by the MIPS
eligible clinician or seen by clinicians in a group] + [the dual
eligible ratio x 5].
(ii) For APM entities and virtual groups, the complex patient bonus
is calculated as follows: [The beneficiary weighted average HCC risk
score for all MIPS eligible clinicians, and if technically feasible,
TINs for models and virtual groups which rely on complete TIN
participation within the APM entity or virtual group, respectively] +
[the average dual eligible ratio for all MIPS eligible clinicians, and
if technically feasible, TINs for models and virtual groups which rely
on complete TIN participation, within the APM entity or virtual group,
respectively, x 5].
(iii) The complex patient bonus cannot exceed 5.0.
(4) Small practice bonus. A small practice bonus of 5 points will
be added to the final score for the 2020 MIPS payment year for MIPS
eligible clinicians, groups, virtual groups, and APM Entities that meet
the definition of a small practice as defined at Sec. 414.1305 and
participate in MIPS by submitting

[[Page 60087]]

data on at least one performance category in the 2018 MIPS performance
period.
(d) Scoring for APM Entities. MIPS eligible clinicians in APM
Entities that are subject to the APM scoring standard are scored using
the methodology under Sec. 414.1370.
(e) Scoring for facility-based measurement. For the payment in 2021
MIPS payment year and subsequent years and subject to paragraph
(e)(6)(vi) of this section, a MIPS eligible clinician or group will be
scored under the quality and cost performance categories using the
methodology described in this paragraph (e).
(1) General. The facility-based measurement scoring standard is the
MIPS scoring methodology applicable for MIPS eligible clinicians
identified as meeting the requirements in paragraph (e)(2) of this
section.
(i) The measures used for facility-based measurement are the
measure set finalized for the fiscal year value-based purchasing
program for which payment begins during the applicable MIPS performance
period.
(ii) Beginning with the 2021 MIPS payment year, the scoring
methodology applicable for MIPS eligible clinicians scored with
facility-based measurement is the Total Performance Score methodology
adopted for the Hospital VBP Program, for the fiscal year for which
payment begins during the applicable MIPS performance period.
(2) Eligibility for facility-based measurement. MIPS eligible
clinicians are eligible for facility-based measurement for a MIPS
payment year if they are determined to be facility-based as an
individual clinician or as part of a group, as follows:
(i) Facility-based individual determination. A MIPS eligible
clinician is facility-based if the clinician meets all of the following
criteria:
(A) Furnishes 75 percent or more of his or her covered professional
services in sites of service identified by the place of service codes
used in the HIPAA standard transaction as an inpatient hospital, on-
campus outpatient hospital, or emergency room setting based on claims
for a 12-month segment beginning on October 1 of the calendar year 2
years prior to the applicable performance period and ending on
September 30 of the calendar year preceding the performance period with
a 30-day claims run out.
(B) Furnishes at least 1 covered professional service in sites of
service identified by the place of service codes used in the HIPAA
standard transaction as an inpatient hospital, or emergency room
setting.
(C) Can be attributed, under the methodology specified in paragraph
(e)(5) of this section, to a facility with a value-based purchasing
score for the applicable period.
(ii) Facility-based group determination. A facility-based group is
a group in which 75 percent or more of its eligible clinician NPIs
billing under the group's TIN meet the requirements under paragraph
(e)(2)(i) of this section.
(3) [Reserved]
(4) Data submission for facility-based measurement. There are no
data submission requirements for individual clinicians to be scored
under facility-based measurement. A group must submit data in the
improvement activities or Promoting Interoperability performance
categories in order to be scored as a facility-based group.
(5) Determination of applicable facility score. (i) A facility-
based clinician is scored with facility-based measurement using the
score derived from the value-based purchasing score for the facility at
which the clinician provided services to the most Medicare
beneficiaries during the period the claims are drawn from in paragraph
(e)(2) of this section. If there is an equal number of Medicare
beneficiaries treated at more than one facility, the value-based
purchasing score for the highest scoring facility is used.
(ii) A facility-based group is scored with facility-based
measurement using the score derived from the value-based purchasing
score for the facility at which the plurality of clinicians identified
as facility-based would have had their score determined under paragraph
(e)(5)(i) of this section.
(6) MIPS performance category scoring under the facility-based
measurement scoring standard--(i) Measures. The quality and cost
measures are those adopted under the value-based purchasing program of
the facility for the year described in paragraph (e)(1)(i) of this
section.
(ii) Benchmarks. The benchmarks are those adopted under the value-
based purchasing program of the facility program for the year described
in paragraph (e)(1) of this section.
(iii) Performance period. The performance period for facility-based
measurement is the performance period for the measures adopted under
the value-based purchasing program of the facility program for the year
described in paragraph (e)(1) of this section.
(iv) Quality. The quality performance category percent score is
established by determining the percentile performance of the facility
in the value-based purchasing program for the specified year as
described in paragraph (e)(1) of this section and awarding a score
associated with that same percentile performance in the MIPS quality
performance category percent score for those MIPS-eligible clinicians
who are not eligible to be scored using facility-based measurement for
the MIPS payment year. A clinician or group receiving a facility-based
performance score will not earn improvement points based on prior
performance in the MIPS quality performance category
(v) Cost. The cost performance category percent score is
established by determining the percentile performance of the facility
in the value-based purchasing program for the specified year as
described in paragraph (e)(1) of this section and awarding a score
associated with that same percentile performance in the MIPS cost
performance category percent score for those MIPS eligible clinicians
who are not eligible to be scored using facility-based measurement for
the MIPS payment year. A clinician or group receiving a facility-based
performance score will not earn improvement points based on prior
performance in the MIPS cost category.
(A) Other cost measures. MIPS eligible clinicians who are scored
under facility-based measurement are not scored on cost measures
described in paragraph (b)(2) of this section.
(B) [Reserved]
(vi) Use of score from facility-based measurement. The MIPS quality
and cost performance category scores will be based on the facility-
based measurement scoring methodology described in paragraph (e)(6) of
this section unless a clinician or group receives a higher combined
MIPS quality and cost performance category score through another MIPS
submission.

0
37. Section 414.1395 is amended by revising paragraphs (b) and (c) to
read as follows:

Sec. 414.1395 Public reporting.

* * * * *
(b) Maintain existing public reporting standards. With the
exception of data that must be mandatorily reported on Physician
Compare, for each program year, CMS relies on established public
reporting standards to guide the information available for inclusion on
Physician Compare. The public reporting standards require data included
on Physician Compare to be statistically valid, reliable, and accurate;
comparable across collection types; and meet the reliability threshold.
And, to be included on the public facing profile pages, the data must
also resonate with website users, as determined by CMS.

[[Page 60088]]

(c) First year measures. For each program year, CMS does not
publicly report any first year measure for the first 2 years, meaning
any measure in its first 2 years of use in the quality and cost
performance categories. After the first 2 years, CMS reevaluates
measures to determine when and if they are suitable for public
reporting.
* * * * *

0
38. Section 414.1400 is revised to read as follows:

Sec. 414.1400 Third party intermediaries.

(a) General. (1) MIPS data may be submitted on behalf of a MIPS
eligible clinician, group, or virtual group by any of the following
third party intermediaries:
(i) A QCDR;
(ii) A qualified registry;
(iii) A health IT vendor; or
(iv) A CMS-approved survey vendor.
(2) QCDRs, qualified registries, and health IT vendors may submit
MIPS data for any of the following MIPS performance categories:
(i) Quality, except for data on the CAHPS for MIPS survey;
(ii) Improvement activities; or
(iii) Promoting Interoperability, if the MIPS eligible clinician,
group, or virtual group is using CEHRT.
(3) CMS-approved survey vendors may submit data on the CAHPS for
MIPS survey for the MIPS quality performance category.
(4) To be approved as a third party intermediary, an entity must
agree to meet the applicable requirements of this section, including,
but not limited to, the following:
(i) A third party intermediary's principle place of business and
retention of any data must be based in the U.S.
(ii) If the data is derived from CEHRT, a QCDR, qualified registry,
or health IT vendor must be able to indicate its data source.
(iii) All data must be submitted in the form and manner specified
by CMS.
(iv) If the clinician chooses to opt-in in accordance with Sec.
414.1310, the third party intermediary must be able to transmit that
decision to CMS.
(5) All data submitted to CMS by a third party intermediary on
behalf of a MIPS eligible clinician, group or virtual group must be
certified by the third party intermediary as true, accurate, and
complete to the best of its knowledge. Such certification must be made
in a form and manner and at such time as specified by CMS.
(b) QCDR approval criteria--(1) QCDR self-nomination. For the 2020
and 2021 MIPS payment years, entities seeking to qualify as a QCDR must
self-nominate September 1 until November 1 of the CY preceding the
applicable performance period. For the 2022 MIPS payment year and
future years, entities seeking to qualify as a QCDR must self-nominate
during a 60-day period during the CY preceding the applicable
performance period (beginning no earlier than July 1 and ending no
later than September 1). Entities seeking to qualify as a QCDR for a
performance period must provide all information required by CMS at the
time of self-nomination and must provide any additional information
requested by CMS during the review process. For the 2021 MIPS payment
year and future years, existing QCDRs that are in good standing may
attest that certain aspects of their previous year's approved self-
nomination have not changed and will be used for the applicable
performance period.
(2) Establishment of a QCDR entity. (i) Beginning with the 2022
MIPS Payment Year, the QCDR must have at least 25 participants by
January 1 of the year prior to the applicable performance period.
(ii) If the entity uses an external organization for purposes of
data collection, calculation, or transmission, it must have a signed,
written agreement with the external organization that specifically
details the responsibilities of the entity and the external
organization. The written agreement must be effective as of September 1
of the year preceding the applicable performance period.
(3) QCDR measures for the quality performance category. (i) For
purposes of QCDRs submitting data for the MIPS quality performance
category, CMS considers the following types of quality measures to be
QCDR measures:
(A) Measures that are not included in the MIPS final list of
quality measures described in Sec. 414.1330(a)(1) for the applicable
MIPS payment year; and
(B) Measures that are included in the MIPS final list of quality
measures described in Sec. 414.1330(a)(1) for the applicable MIPS
payment year, but have undergone substantive changes, as determined by
CMS.
(ii) For the 2020 MIPS payment year and future years, an entity
seeking to become a QCDR must submit specifications for each measure,
activity, and objective that the entity intends to submit to for MIPS
(including the information described in paragraphs (b)(3)(ii)(A) and
(B) of this section) at the time of self-nomination. In addition, no
later than 15 calendar days following CMS approval of any QCDR measure
specifications, the entity must publicly post the measure
specifications for each QCDR measure (including the CMS-assigned QCDR
measure ID) and provide CMS with a link to where this information is
posted.
(A) For QCDR measures, the entity must submit the measure
specifications for each QCDR measure, including: Name/title of
measures, NQF number (if NQF-endorsed), descriptions of the
denominator, numerator, and when applicable, denominator exceptions,
denominator exclusions, risk adjustment variables, and risk adjustment
algorithms.
(B) For MIPS quality measures, the entity must submit the MIPS
measure IDs and specialty-specific measure sets, as applicable.
(iii) A QCDR must include the CMS-assigned QCDR measure ID when
submitting data on any QCDR measure to CMS.
(c) Qualified registry approval criteria--(1) Qualified registry
self-nomination. For the 2020 and 2021 MIPS payment years, entities
seeking to qualify as a qualified registry must self-nominate from
September 1 until November 1 of the CY preceding the applicable
performance period. For the 2022 MIPS payment year and future years,
entities seeking to qualify as a qualified registry must self-nominate
during a 60-day period during the CY preceding the applicable
performance period (beginning no earlier than July 1 and ending no
later than September 1). Entities seeking to qualify as a qualified
registry for a performance period must provide all information required
by CMS at the time of self-nomination and must provide any additional
information requested by CMS during the review process. For the 2021
MIPS payment year and future years, existing qualified registries that
are in good standing may attest that certain aspects of their previous
year's approved self-nomination have not changed and will be used for
the applicable performance period.
(2) Establishment of a qualified registry entity. Beginning with
the 2022 MIPS Payment Year, the qualified registry must have at least
25 participants by January 1 of the year prior to the applicable
performance period.
(d) Health IT vendor approval criteria. Health IT vendors must meet
the criteria specified at paragraph (a)(4) of this section.
(e) CMS-approved survey vendor approval criteria. Entities seeking
to be a CMS-approved survey vendor for any MIPS performance period must
submit a survey vendor application to CMS in a form and manner
specified by CMS for each MIPS performance period for

[[Page 60089]]

which it wishes to transmit such data. The application and any
supplemental information requested by CMS must be submitted by
deadlines specified by CMS. For an entity to be a CMS-approved survey
vendor, it must meet the following criteria:
(1) The entity must have sufficient experience, capability, and
capacity to accurately report CAHPS data, including:
(i) At least 3 years of experience administering mixed-mode surveys
(that is, surveys that employ multiple modes to collect date),
including mail survey administration followed by survey administration
via Computer Assisted Telephone Interview (CATI);
(ii) At least 3 years of experience administering surveys to a
Medicare population;
(iii) At least 3 years of experience administering CAHPS surveys
within the past 5 years;
(iv) Experience administering surveys in English and at least one
other language for which a translation of the CAHPS for MIPS survey is
available;
(v) Use equipment, software, computer programs, systems, and
facilities that can verify addresses and phone numbers of sampled
beneficiaries, monitor interviewers, collect data via CATI,
electronically administer the survey and schedule call-backs to
beneficiaries at varying times of the day and week, track fielded
surveys, assign final disposition codes to reflect the outcome of data
collection of each sampled case, and track cases from mail surveys
through telephone follow-up activities; and
(vi) Employment of a program manager, information systems
specialist, call center supervisor and mail center supervisor to
administer the survey.
(2) The entity has certified that it has the ability to maintain
and transmit quality data in a manner that preserves the security and
integrity of the data.
(3) The entity has successfully completed, and has required its
subcontractors to successfully complete, vendor training(s)
administered by CMS or its contractors.
(4) The entity has submitted a quality assurance plan and other
materials relevant to survey administration, as determined by CMS,
including cover letters, questionnaires and telephone scripts.
(5) The entity has agreed to participate and cooperate, and has
required its subcontractors to participate and cooperate, in all
oversight activities related to survey administration conducted by CMS
or its contractors.
(6) The entity has sent an interim survey data file to CMS that
establishes the entity's ability to accurately report CAHPS data.
(f) Remedial action and termination of third party intermediaries.
(1) If CMS determines that a third party intermediary has ceased to
meet one or more of the applicable criteria for approval, or has
submitted data that is inaccurate, unusable, or otherwise compromised,
CMS may take one or more of the following remedial actions after
providing written notice to the third party intermediary:
(i) Require the third party intermediary to submit a corrective
action plan (CAP) to CMS to address the identified deficiencies or data
issue, including the actions it will take to prevent the deficiencies
or data issues from recurring. The CAP must be submitted to CMS by a
date specified by CMS.
(ii) Publicly disclose the entity's data error rate on the CMS
website until the data error rate falls below 3 percent.
(2) CMS may immediately or with advance notice terminate the
ability of a third party intermediary to submit MIPS data on behalf of
a MIPS eligible clinician, group, or virtual group for one or more of
the following reasons:
(i) CMS has grounds to impose remedial action;
(ii) CMS has not received a CAP within the specified time period or
the CAP is not accepted by CMS; or
(iii) The third party intermediary fails to correct the
deficiencies or data errors by the date specified by CMS.
(3) For purposes of paragraph (f) of this section, CMS may
determine that submitted data is inaccurate, unusable, or otherwise
compromised if the submitted data:
(i) Includes, without limitation, TIN/NPI mismatches, formatting
issues, calculation errors, or data audit discrepancies; and
(ii) Affects more than 3 percent of the total number of MIPS
eligible clinicians or group for which data was submitted by the third
party intermediary.
(g) Auditing of entities submitting MIPS data. Any third party
intermediary must comply with the following procedures as a condition
of its qualification and approval to participate in MIPS as a third
party intermediary.
(1) The entity must make available to CMS the contact information
of each MIPS eligible clinician or group on behalf of whom it submits
data. The contact information must include, at a minimum, the MIPS
eligible clinician or group's practice phone number, address, and, if
available, email.
(2) The entity must retain all data submitted to CMS for purposes
of MIPS for 6 years from the end of the MIPS performance period.
(3) For the purposes of auditing, CMS may request any records or
data retained for the purposes of MIPS for up to 6 years from the end
of the MIPS performance period.

0
39. Section 414.1405 is amended by--
0
a. Adding paragraphs (b)(6) and (d)(5);
0
b. Revising paragraph (e); and
0
c. Adding paragraph (f).
The additions and revision read as follows:

Sec. 414.1405 Payment.

* * * * *
(b) * * *
(6) The performance threshold for the 2021 MIPS payment year is 30
points.
* * * * *
(d) * * *
(5) The additional performance threshold for the 2021 MIPS payment
year is 75 points.
(e) Application of adjustments to payments. Except as specified in
paragraph (f) of this section, in the case of covered professional
services (as defined in section 1848(k)(3)(A) of the Act) furnished by
a MIPS eligible clinician during a MIPS payment year beginning with
2019, the amount otherwise paid under Part B with respect to such
covered professional services and MIPS eligible clinician for such
year, is multiplied by 1, plus the sum of the MIPS payment adjustment
factor divided by 100, and as applicable, the additional MIPS payment
adjustment factor divided by 100.
(f) Exception to application of MIPS payment adjustment factors to
model-specific payments under section 1115A APMs. Effective for the
2019 MIPS payment year, the payment adjustment factors specified under
paragraph (e) of this section are not applicable to payments that meet
all of the following conditions:
(1) Are made only to participants in a model tested under section
1115A of the Act;
(2) Would otherwise be subject to the requirement to apply the MIPS
payment adjustment factors if the payment is made with respect to a
MIPS eligible clinician participating in a section 1115A model; and
(3) Either have a specified payment amount or are paid according to
a methodology for calculating a model-specific payment that is applied
in a consistent manner to all model participants, such that application
of the MIPS payment adjustment factors would potentially interfere with
CMS's ability to effectively evaluate the impact of the APM.

[[Page 60090]]

0
40. Section 414.1415 is amended, effective January 1, 2019, by revising
paragraphs (a)(1)(i) and (ii), (b)(1), (c) introductory text,
(c)(3)(i)(A), and (c)(6) to read as follows:

Sec. 414.1415 Advanced APM criteria.

(a) * * *
(1) * * *
(i) Require at least 50 percent, or for QP Performance Periods
beginning in 2019, 75 percent of eligible clinicians in each
participating APM Entity group, or for APMs in which hospitals are the
APM Entities, each hospital, to use CEHRT to document and communicate
clinical care to their patients or health care providers; or
(ii) For QP Performance Periods prior to 2019, for the Shared
Savings Program, apply a penalty or reward to an APM Entity based on
the degree of the use of CEHRT of the eligible clinicians in the APM
Entity.
(b) * * *
(1) To be an Advanced APM, an APM must include quality measure
performance as a factor when determining payment to participants for
covered professional services under the terms of the APM.
* * * * *
(c) Financial risk. To be an Advanced APM, except as described in
paragraph (c)(6) of this section, an APM must either meet the financial
risk standard under paragraph (c)(1) or (2) of this section and the
nominal amount standard under paragraph (c)(3) or (4) of this section
or be an expanded Medical Home Model under section 1115A(c) of the Act.
* * * * *
(3) * * *
(i) * * *
(A) For QP Performance Periods beginning in 2017, through 2024, 8
percent of the average estimated total Medicare Parts A and B revenue
of all providers and suppliers in participating APM Entities; or
* * * * *
(6) Capitation. A full capitation arrangement meets this Advanced
APM criterion. For purposes of this part, a full capitation arrangement
means a payment arrangement in which a per capita or otherwise
predetermined payment is made under the APM for all items and services
furnished to a population of beneficiaries during a fixed period of
time, and no settlement is performed to reconcile or share losses
incurred or savings earned by the APM Entity. Arrangements between CMS
and Medicare Advantage Organizations under the Medicare Advantage
program (42 U.S.C. 422) are not considered capitation arrangements for
purposes of this paragraph (c)(6).
* * * * *

0
41. Section 414.1415 is further amended (effective January 1, 2010) by
revising paragraphs (b)(2) and (3) to read as follows:

Sec. 414.1415 Advanced APM criteria.

* * * * *
(b) * * *
(2) At least one of the quality measures used in the payment
arrangement as specified in paragraph (b)(1) of this section must:
(i) For QP Performance Periods before January 1, 2020, have an
evidence-based focus, be reliable and valid, and meet at least one of
the following criteria:
(A) Used in the MIPS quality performance category, as described in
Sec. 414.1330;
(B) Endorsed by a consensus-based entity;
(C) Developed under section 1848(s) of the Act;
(D) Submitted in response to the MIPS Call for Quality Measures
under section 1848(q)(2)(D)(ii) of the Act; or
(E) Any other quality measures that CMS determines to have an
evidence-based focus and to be reliable and valid; and
(ii) For QP Performance Periods beginning on or after January1,
2020, be:
(A) Finalized on the MIPS final list of measures, as described in
Sec. 414.1330;
(B) Endorsed by a consensus-based entity; or
(C) Determined by CMS to be evidenced-based, reliable, and valid.
(3) In addition to the quality measure described under paragraph
(b)(2) of this section, the quality measures upon which an Advanced APM
bases the payment in paragraph (b)(1) of this section must include at
least one additional measure that is an outcome measure unless CMS
determines that there are no available or applicable outcome measures
included in the MIPS final quality measures list for the Advanced APM's
first QP Performance Period. Beginning January 1, 2020, the included
outcome measure must satisfy the criteria in paragraph (b)(2) of this
section.
* * * * *

0
42. Section 414.1420 is amended effective January 1, 2019, by revising
paragraphs (d) introductory text, (d)(3)(i), and (d)(7) to read as
follows:

Sec. 414.1420 Other payer advanced APM criteria.

* * * * *
(d) Financial risk. To be an Other Payer Advanced APM, except as
described in paragraph (d)(7) of this section, a payment arrangement
must meet either the financial risk standard under paragraph (d)(1) or
(2) of this section and the nominal amount standard under paragraph
(d)(3) or (4) of this section, or be a Medicaid Medical Home Model with
criteria comparable to an expanded Medical Home Model under section
1115A(c) of the Act.
* * * * *
(3) * * *
(i) For QP Performance Periods 2019 through 2024, 8 percent of the
total combined revenues from the payer to providers and other entities
under the payment arrangement if financial risk is expressly defined in
terms of revenue; or, 3 percent of the expected expenditures for which
an APM Entity is responsible under the payment arrangement.
* * * * *
(7) Capitation. A full capitation arrangement meets this Other
Payer Advanced APM criterion. For purposes of paragraph (d)(3) of this
section, a full capitation arrangement means a payment arrangement in
which a per capita or otherwise predetermined payment is made under the
payment arrangement for all items and services furnished to a
population of beneficiaries during a fixed period of time, and no
settlement is performed for the purpose of reconciling or sharing
losses incurred or savings earned by the participant. Arrangements made
directly between CMS and Medicare Advantage Organizations under the
Medicare Advantage program (42 U.S.C. 422) are not considered
capitation arrangements for purposes of this paragraph (c)(7).
* * * * *

0
43. Section 414.1420 is further amended (effective January 1, 2020) by
revising paragraphs (b), (c)(2) and (3) to read as follows:

Sec. 414.1420 Other payer advanced APM criteria.

* * * * *
(b) Use of CEHRT. To be an Other Payer Advanced APM, CEHRT must be
used by at least 50 percent, or for QP Performance Periods on or after
January 1, 2020, 75 percent of participants in each participating APM
Entity group, or each hospital if hospitals are the APM Entities, in
the other payer arrangement to document and communicate clinical care.
(c) * * *
(2) At least one of the quality measures used in the payment
arrangement as specified in paragraph (c)(1) of this section must:

[[Page 60091]]

(i) For QP Performance Period before January 1, 2020, have an
evidence-based focus, be reliable and valid, and meet at least one of
the following criteria:
(A) Used in the MIPS quality performance category, as described in
Sec. 414.1330;
(B) Endorsed by a consensus-based entity;
(C) Developed under section 1848(s) of the Act;
(D) Submitted in response to the MIPS Call for Quality Measures
under section 1848(q)(2)(D)(ii) of the Act; or
(E) Any other quality measures that CMS determines to have an
evidence-based focus and to be reliable and valid; and
(ii) For QP Performance Periods beginning on or after January 1,
2020, be:
(A) Finalized on the MIPS final list of measures, as described in
Sec. 414.1330;
(B) Endorsed by a consensus-based entity; or
(C) Determined by CMS to be evidenced-based, reliable, and valid.
(3) To meet the quality measure use criterion under paragraph
(c)(1) of this section, a payment arrangement must:
(i) For QP Performance Periods before January 1, 2020, use an
outcome measure if there is an applicable outcome measure on the MIPS
quality measure list. This criterion also applies for payment
arrangements determined to be Other Payer Advanced APMs on or before
January 1, 2020, but only for the Other Payer Advanced APM
determination made with respect to the arrangement for the CY 2020 QP
Performance Period (regardless of whether that determination is a
single- or multi-year determination).
(ii) For QP Performance Periods on or after January 1, 2020, in
addition to the quality measure described under paragraph (c)(2) of
this section, use at least one additional measure that is an outcome
measure and meets the criteria in paragraph (c)(2)(ii) of this section
if there is such an applicable outcome measure on the MIPS quality
measure list.
* * * * *

0
44. Section 414.1440 is amended by revising paragraphs (d)(1) through
(3) to read as follows:

Sec. 414.1440 Qualifying APM participant determination: All-payer
combination option.

* * * * *
(d) * * *
(1) CMS performs QP determinations following the QP Performance
Period using payment amount and/or patient count information submitted
from January 1 through each of the respective QP determination dates:
March 31, June 30, and August 31. CMS will use data for the same time
periods for the Medicare and other payer portions of Threshold Score
calculations under the All-Payer Combination Option. CMS will use the
payment amount or patient count method, applying the more advantageous
of the two for both the Medicare and other payer portions of the
Threshold score calculation, regardless of the method used for the
Medicare Threshold Score calculation.
(2) An APM Entity may request that CMS make QP determinations at
the APM Entity level, an eligible clinician may request that CMS make
QP determinations at the eligible clinician level, and an eligible
clinician or an APM Entity may request that CMS makes QP determinations
at the TIN-level in instances where all clinicians who reassigned
billing rights to the TIN are participating in a single APM Entity. CMS
makes QP determinations at either the APM Entity, eligible clinician,
or TIN level. Eligible clinicians assessed at the eligible clinician
level under the Medicare Option at Sec. 414.1425(b)(2) will be
assessed at the eligible clinician level only under the All-Payer
Combination Option. Eligible Clinicians may meet the Medicare and the
All-Payer Combination Option thresholds using the payment amount method
for both thresholds, the patient account method for both thresholds, or
the payment amount method for one threshold and the patient account
method for the other threshold.
(3) CMS uses data at the same level for the Medicare and other
payer portions of Threshold Score calculations under the All-Payer
Combination Option. When QP determinations are made at the eligible
clinician or, at the TIN level when all clinicians who have reassigned
billing rights to the TIN are included in a single APM Entity; and if
the Medicare Threshold score for the APM Entity group is higher than
when calculated for the eligible clinician or TIN, CMS makes QP
determinations using a weighted Medicare Threshold Score that is
factored into an All-Payer Combination Option Threshold Score.
* * * * *

0
45. Section 414.1445 is amended by revising paragraph (b)(1), adding
paragraph (c)(2)(i), and reserving paragraph (c)(2)(ii) to read as
follows:

Sec. 414.1445 Determination of other payer advanced APMs.

* * * * *
(b) * * *
(1) Payer initiated Other Payer Advanced APM determination process.
Beginning in 2018, and each year thereafter, at a time determined by
CMS a payer with a Medicare Health Plan payment arrangement may
request, in a form and manner specified by CMS, that CMS determine
whether a Medicare Health Plan payment arrangement meets the Other
Payer Advanced APM criteria set forth in Sec. 414.1420. A payer with a
Medicare Health Plan payment arrangement must submit its requests by
the annual Medicare Advantage bid deadline of the year prior to the
relevant QP Performance Period. A Medicare Health Plan is a Medicare
Advantage plan, a section 1876 cost plan, a PACE organization operated
under section 1894, and any similar plan which provides Medicare
benefits under demonstration or waiver authority (other than an APM as
defined in section 1833(z)(3)(C) of the Act).
* * * * *
(c) * * *
(2) * * *
(i) Based on the submission by an eligible clinician or payer of
evidence that CMS determines sufficiently demonstrates that CEHRT is
used as specified in Sec. 414.1420(b) by participants in the payment
arrangement, CMS will consider the CEHRT criterion in Sec. 414.1420(b)
is satisfied for that payment arrangement.
(ii) [Reserved]
* * * * *

PART 415--SERVICES FURNISHED BY PHYSICIANS IN PROVIDERS,
SUPERVISING PHYSICIANS IN TEACHING SETTINGS, AND RESIDENTS IN
CERTAIN SETTINGS

0
46. The authority citation for part 415 is revised to read as follows:

Authority: 42 U.S.C. 1302 and 1395hh.

0
47. Section 415.172 is amended by revising paragraph (b) to read as
follows:

Sec. 415.172 Physician fee schedule payment for services of teaching
physicians.

* * * * *
(b) Documentation. Except for services furnished as set forth in
Sec. Sec. 415.174 (concerning an exception for services furnished in
hospital outpatient and certain other ambulatory settings), 415.176
(concerning renal dialysis services), and 415.184 (concerning
psychiatric services), the medical records must document the teaching
physician was present at the time the service is furnished. The
presence of the teaching physician during procedures and evaluation and
management services may be demonstrated by the notes in the medical
records made by a physician, resident, or nurse.
* * * * *

[[Page 60092]]

0
48. Section 415.174 is amended--
0
a. In paragraph (a)(3)(iii) by removing ``;'' and adding in its place
``; and'';
0
b. In paragraph (a)(3)(iv) by removing ``; and'' and adding in its
place ``.'';
0
c. By removing paragraph (a)(3)(v); and
0
d. By adding paragraph (a)(6).
The addition reads as follows:

Sec. 415.174 Exception: Evaluation and management services furnished
in certain centers.

(a) * * *
(6) The medical records must document the extent of the teaching
physician's participation in the review and direction of services
furnished to each beneficiary. The extent of the teaching physician's
participation may be demonstrated by the notes in the medical records
made by a physician, resident, or nurse.
* * * * *

PART 425--MEDICARE SHARED SAVINGS PROGRAM

0
49. The authority citation for part 425 is revised to read as follows:

Authority: 42 U.S.C. 1302, 1306, 1395hh, and 1395jjj.

0
50. Section 425.20 is amended--
0
a. By revising the definition of ``Agreement period'';
0
b. By adding in alphabetical order definitions for ``Certified
Electronic Health Record Technology (CEHRT)'' and ``Eligible
clinician''; and
0
c. By revising the definition of ``Performance year''.
The revisions and additions read as follows:

Sec. 425.20 Definitions.

* * * * *
Agreement period means the term of the participation agreement.
* * * * *
Certified Electronic Health Record Technology (CEHRT) has the same
meaning given this term under Sec. 414.1305 of this chapter.
* * * * *
Eligible clinician has the same meaning given this term under Sec.
414.1305 of this chapter.
* * * * *
Performance year means the 12-month period beginning on January 1
of each year during the agreement period, unless otherwise specified in
Sec. 425.200(c) or noted in the participation agreement.
* * * * *

Sec. 425.100 [Amended]

0
51. Section 425.100 is amended--
0
a. In paragraph (b) by removing the phrase ``under Sec. 425.604, Sec.
425.606 or Sec. 425.610'' and adding in its place the phrase ``under
Sec. 425.604, Sec. 425.606, Sec. 425.609 or Sec. 425.610''; and
0
b. In paragraph (c) by removing the phrase ``under Sec. 425.606 or
Sec. 425.610'' and adding in its place the phrase ``under Sec.
425.606, Sec. 425.609 or Sec. 425.610''.

0
52. Section 425.200 is amended--
0
a. By revising paragraph (a);
0
b. By revising the heading of paragraph (b);
0
c. By removing paragraph (b)(2) introductory text, adding a heading for
paragraph (b)(2), and revising paragraph (b)(2)(ii); and
0
d. By removing paragraph (b)(3) introductory text, adding a heading for
paragraph (b)(3); and
0
e. By revising paragraphs (c) and (d).
The revisions and additions read as follows:

Sec. 425.200 Participation agreement with CMS.

(a) General. In order to participate in the Shared Savings Program,
an ACO must enter into a participation agreement with CMS for a period
of not less than the number of years specified in this section.
(b) Agreement period.* * *
(2) For 2013 and through 2016.* * *
(ii) The term of the participation agreement is 3 years unless all
of the following conditions are met to extend the participation
agreement by 6 months:
(A) The ACO entered an agreement period starting on January 1,
2016.
(B) The ACO elects to extend its agreement period until June 30,
2019.
(1) The ACO's election to extend its agreement period is made in
the form and manner and according to the timeframe established by CMS;
and
(2) An ACO executive who has the authority to legally bind the ACO
must certify the election described in paragraph (b)(2)(ii)(B) of this
section.
(3) For 2017 and all subsequent years. * * *
(c) Performance year. The ACO's performance year under the
participation agreement is the 12 month period beginning on January 1
of each year during the term of the participation agreement unless
otherwise noted in its participation agreement, and except as follows:
(1) For an ACO with a start date of April 1, 2012, or July 1, 2012,
the ACO's first performance year is defined as 21 months or 18 months,
respectively.
(2) For an ACO that entered a first or second agreement period with
a start date of January 1, 2016, and that elects to extend its
agreement period by a 6-month period under paragraph (b)(2)(ii)(B) of
this section, the ACO's fourth performance year is the 6-month period
between January 1, 2019, and June 30, 2019.
(d) Submission of measures. For each performance year of the
agreement period, ACOs must submit measures in the form and manner
required by CMS according to Sec. 425.500(c), and as applicable
according to Sec. Sec. 425.608 and 425.609.
* * * * *

Sec. 425.221 [Amended]

0
53. Section 425.221 is amended--
0
a. In paragraph (b)(1)(i) by removing the phrase ``December 31st of
such performance year'' and adding in its place the phrase ``the last
calendar day of the performance year''; and
0
b. In paragraph (b)(2) by removing the phrase ``December 31 of a
performance year'' and adding in its place the phrase ``the last
calendar day of a performance year''.

0
54. Section 425.302 is amended--
0
a. In paragraph (a)(3)(i) by removing the phrase ``requirements; and''
and adding in its place the phrase ``requirements;'';
0
b. In paragraph (a)(3)(ii) by removing the phrase ``owed to CMS.'' and
adding in its place the phrase ``owed to CMS; and''; and
0
c. Adding paragraph (a)(3)(iii).
The addition reads as follows:

Sec. 425.302 Program requirements for data submission and
certifications.

(a) * * *
(3) * * *
(iii) That the percentage of eligible clinicians participating in
the ACO that use CEHRT to document and communicate clinical care to
their patients or other health care providers meets or exceeds the
applicable percentage specified by CMS at Sec. 425.506(f).
* * * * *

Sec. 425.315 [Amended]

0
55. Section 425.315 is amended in paragraph (a)(1)(ii) by removing the
phrase ``Sec. 425.604(f), Sec. 425.606(h) or Sec. 425.610(h)'' and
adding in its place the phrase ``Sec. 425.604(f), Sec. 425.606(h),
Sec. 425.609(e) or Sec. 425.610(h)''.

0
56. Section 425.400 is amended by--
0
a. Revising paragraph (a)(1)(ii);
0
b. Revising paragraphs (c)(1)(iv) introductory text, (c)(1)(iv)(A),
(c)(1)(iv)(B) introductory text, and (c)(1)(iv)(B)(5); and
0
c. Adding paragraphs (c)(1)(iv)(B)(6) and (7).

[[Page 60093]]

The revisions and additions read as follows:

Sec. 425.400 General.

(a)(1) * * *
(ii) CMS applies a step-wise process based on the beneficiary's
utilization of primary care services provided under Title XVIII by a
physician who is an ACO professional during each performance year for
which shared savings are to be determined and, with respect to ACOs
participating in a 6-month performance year during CY 2019, during the
entirety of CY 2019 as specified in Sec. 425.609.
* * * * *
(c) * * *
(1) * * *
(iv) For performance years starting on January 1, 2019, and
subsequent performance years as follows:
(A) CPT codes:
(1) 99201 through 99215 (codes for office or other outpatient visit
for the evaluation and management of a patient).
(2) 99304 through 99318 (codes for professional services furnished
in a nursing facility; services identified by these codes furnished in
a SNF are excluded).
(3) 99319 through 99340 (codes for patient domiciliary, rest home,
or custodial care visit).
(4) 99341 through 99350 (codes for evaluation and management
services furnished in a patients' home for claims identified by place
of service modifier 12).
(5) 99487, 99489 and 99490 (codes for chronic care management).
(6) 99495 and 99496 (codes for transitional care management
services).
(7) 99497 and 99498 (codes for advance care planning).
(8) 96160 and 96161 (codes for administration of health risk
assessment).
(9) 99354 and 99355 (add-on codes, for prolonged evaluation and
management or psychotherapy services beyond the typical service time of
the primary procedure; when the base code is also a primary care
service code under this paragraph (c)(1)).
(10) 99484, 99492, 99493 and 99494 (codes for behavioral health
integration services).
(B) HCPCS codes:
* * * * *
(5) G0444 (codes for annual depression screening service).
(6) G0442 (code for alcohol misuse screening service).
(7) G0443 (code for alcohol misuse counseling service).

0
57. Section 425.401 is amended by revising paragraph (b) introductory
text to read as follows:

Sec. 425.401 Criteria for a beneficiary to be assigned to an ACO.

* * * * *
(b) A beneficiary is excluded from the prospective assignment list
of an ACO that is participating under prospective assignment under
Sec. 425.400(a)(3) at the end of a performance or benchmark year and
quarterly during each performance year consistent with Sec.
425.400(a)(3)(ii), or at the end of CY 2019 as specified in Sec.
425.609(b)(1)(ii), if the beneficiary meets any of the following
criteria during the performance or benchmark year:
* * * * *

0
58. Section 425.402 is amended by revising paragraph (e)(2) to read as
follows:

Sec. 425.402 Basic assignment methodology.

* * * * *
(e) * * *
(2) Beneficiaries are added to the ACO's list of assigned
beneficiaries if all of the following conditions are satisfied:
(i) For performance year 2018:
(A) The beneficiary must have had at least one primary care service
during the assignment window as defined under Sec. 425.20 with a
physician who is an ACO professional in the ACO who is a primary care
physician as defined under Sec. 425.20 or who has one of the primary
specialty designations included in paragraph (c) of this section.
(B) The beneficiary meets the eligibility criteria established at
Sec. 425.401(a) and must not be excluded by the criteria at Sec.
425.401(b). The exclusion criteria at Sec. 425.401(b) apply for
purposes of determining beneficiary eligibility for alignment to ACOs
under all tracks based on the beneficiary's designation of an ACO
professional as responsible for coordinating their overall care under
paragraph (e) of this section.
(C) The beneficiary must have designated an ACO professional who is
a primary care physician as defined at Sec. 425.20, a physician with a
specialty designation included at paragraph (c) of this section, or a
nurse practitioner, physician assistant, or clinical nurse specialist
as responsible for coordinating their overall care.
(D) If a beneficiary has designated a provider or supplier outside
the ACO who is a primary care physician as defined at Sec. 425.20, a
physician with a specialty designation included at paragraph (c) of
this section, or a nurse practitioner, physician assistant, or clinical
nurse specialist, as responsible for coordinating their overall care,
the beneficiary is not added to the ACO's list of assigned
beneficiaries under the assignment methodology in paragraph (b) of this
section.
(ii) For performance years starting on January 1, 2019, and
subsequent performance years:
(A) The beneficiary meets the eligibility criteria established at
Sec. 425.401(a) and must not be excluded by the criteria at Sec.
425.401(b). The exclusion criteria at Sec. 425.401(b) apply for
purposes of determining beneficiary eligibility for alignment to an ACO
based on the beneficiary's designation of an ACO professional as
responsible for coordinating their overall care under paragraph (e) of
this section, regardless of the ACO's assignment methodology selection
under Sec. 425.400(a)(4)(ii).
(B) The beneficiary must have designated an ACO professional as
responsible for coordinating their overall care.
(C) If a beneficiary has designated a provider or supplier outside
the ACO as responsible for coordinating their overall care, the
beneficiary is not added under the assignment methodology in paragraph
(b) of this section to the ACO's list of assigned beneficiaries for a
12-month performance year or the ACO's list of assigned beneficiaries
for a 6-month performance year, which is based on the entire CY 2019 as
provided in Sec. 425.609.
(D) The beneficiary is not assigned to an entity participating in a
model tested or expanded under section 1115A of the Act under which
claims-based assignment is based solely on claims for services other
than primary care services and for which there has been a determination
by the Secretary that waiver of the requirement in section
1899(c)(2)(B) of the Act is necessary solely for purposes of testing
the model.
* * * * *

Sec. 425.404 [Amended]

0
59. Section 425.404 is amended in paragraph (b) by removing the phrase
``For performance year 2019 and subsequent performance years'' and
adding in its place the phrase ``For performance years starting on
January 1, 2019, and subsequent performance years''.

0
60. Section 425.502 is amended--
0
a. In paragraph (e)(4)(vi) by removing the phrase ``For performance
year 2017'' and adding in its place the phrase ``For performance year
2017 and subsequent performance years'';
0
b. By adding a new paragraph (e)(4)(vii);
0
c. By revising paragraph (f) introductory text;

[[Page 60094]]

0
d. By redesignating paragraphs (f)(1) and (2) as paragraphs (f)(2)(i)
and (ii);
0
e. By adding a new paragraph (f)(1);
0
f. By adding a new paragraph (f)(2) introductory text;
0
g. In newly redesignated paragraph (f)(2)(i) by removing the phrase
``for performance year 2017'' and adding in its place the phrase ``for
the relevant performance year'';
0
h. By removing paragraph (f)(4); and
0
i. By redesignating paragraph (f)(5) as paragraph (f)(4).
The revisions and additions read as follows:

Sec. 425.502 Calculating the ACO quality performance score.

* * * * *
(e) * * *
(4) * * *
(vii) For performance year 2017 and subsequent performance years,
if an ACO receives the mean Shared Savings Program ACO quality score
under paragraph (f) of this section, in the next performance year for
which the ACO receives a quality performance score based on its own
quality reporting, quality improvement is measured based on a
comparison between the performance in that year and the most recently
available prior performance year in which the ACO reported quality.
(f) Extreme and uncontrollable circumstances. For performance year
2017 and subsequent performance years, including the applicable quality
data reporting period for the performance year if the quality reporting
period is not extended, CMS uses an alternative approach to calculating
the quality score for ACOs affected by extreme and uncontrollable
circumstances instead of the methodology specified in paragraphs (a)
through (e) of this section as follows:
(1) CMS determines the ACO was affected by an extreme and
uncontrollable circumstance based on either of the following:
(i) Twenty percent or more of the ACO's assigned beneficiaries
reside in an area identified under the Quality Payment Program as being
affected by an extreme and uncontrollable circumstance.
(A) Assignment is determined under subpart E of this part.
(B) In making this determination for performance year 2017, CMS
uses the final list of beneficiaries assigned to the ACO for the
performance year. For performance year 2018 and subsequent performance
years, CMS uses the list of assigned beneficiaries used to generate the
Web Interface quality reporting sample.
(ii) The ACO's legal entity is located in an area identified under
the Quality Payment Program as being affected by an extreme and
uncontrollable circumstance. An ACO's legal entity location is based on
the address on file for the ACO in CMS' ACO application and management
system.
(2) If CMS determines the ACO meets the requirements of paragraph
(f)(1) of this section, CMS calculates the ACO's quality score as
follows:
* * * * *

0
61. Section 425.506 is amended--
0
a. In paragraph (b) by removing the phrase ``As part of the quality
performance score'' and adding in its place the phrase ``For
performance years 2012 through 2018, as part of the quality performance
score'';
0
b. In paragraph (c) by removing the phrase ``Performance on this
measure'' and adding in its place the phrase ``For performance years
2012 through 2018, performance on this measure'';
0
c. In paragraph (e) introductory text by removing the phrase ``For 2017
and subsequent years'' and adding in its place the phrase ``For 2017
and 2018''; and
0
d. By adding paragraph (f).
The addition reads as follows:

Sec. 425.506 Incorporating reporting requirements related to
adoption of certified electronic health record technology.

* * * * *
(f) For performance years starting on January 1, 2019, and
subsequent performance years, ACOs in a track that--
(1) Does not meet the financial risk standard to be an Advanced APM
must certify annually that the percentage of eligible clinicians
participating in the ACO that use CEHRT to document and communicate
clinical care to their patients or other health care providers meets or
exceeds 50 percent; or
(2) Meets the financial risk standard to be an Advanced APM must
certify annually that the percentage of eligible clinicians
participating in the ACO that use CEHRT to document and communicate
clinical care to their patients or other health care providers meets or
exceeds the threshold established under Sec. 414.1415(a)(1)(i) of this
chapter.

0
62. Section 425.602 is amended by adding paragraph (c) to read as
follows:

Sec. 425.602 Establishing, adjusting, and updating the benchmark for
an ACO's first agreement period.

* * * * *
(c) January 1, 2019 through June 30, 2019 performance year. In
determining performance for the January 1, 2019 through June 30, 2019
performance year described in Sec. 425.609(b) CMS does all of the
following:
(1) When adjusting the benchmark using the methodology set forth in
paragraph (a)(9) of this section and Sec. 425.609(b), CMS adjusts for
severity and case mix between BY3 and CY 2019.
(2) When updating the benchmark using the methodology set forth in
paragraph (b) of this section and Sec. 425.609(b), CMS updates the
benchmark based on growth between BY3 and CY 2019.

0
63. Section 425.603 is amended by adding paragraph (g) to read as
follows:

Sec. 425.603 Resetting, adjusting, and updating the benchmark for a
subsequent agreement period.

* * * * *
(g) In determining performance for the January 1, 2019 through June
30, 2019 performance year described in Sec. 425.609(b) CMS does all of
the following:
(1) When adjusting the benchmark using the methodology set forth in
paragraph (c)(10) of this section and Sec. 425.609(b), CMS adjusts for
severity and case mix between BY3 and CY 2019.
(2) When updating the benchmark using the methodology set forth in
paragraph (d) of this section and Sec. 425.609(b), CMS updates the
benchmark based on growth between BY3 and CY 2019.

0
64. Section 425.604 is amended by adding paragraph (g) to read as
follows:

Sec. 425.604 Calculation of savings under the one-sided model.

* * * * *
(g) January 1, 2019 through June 30, 2019 performance year. Shared
savings for the January 1, 2019 through June 30, 2019 performance year
are calculated as described in Sec. 425.609.

0
65. Section 425.606 is amended--
0
a. In paragraph (i) introductory text by removing the phrase ``For
performance year 2017'' and adding in its place the phrase ``For
performance year 2017 and subsequent performance years'';
0
b. In paragraph (i)(1) remove the phrase ``2017''; and
0
c. By adding paragraph (j).
The addition reads as follows:

Sec. 425.606 Calculation of shared savings and losses under Track 2.

* * * * *
(j) January 1, 2019 through June 30, 2019. Shared savings or shared
losses for the January 1, 2019 through June 30, 2019 performance year
are calculated as described in Sec. 425.609.

0
66. Section 425.609 is added to read as follows:

[[Page 60095]]

Sec. 425.609 Determining performance for a 6-month performance year
during CY 2019.

(a) General. An ACO's financial and quality performance for a 6-
month performance year during 2019 are determined as described in this
section.
(b) January 2019 through June 2019. For ACOs participating in a 6-
month performance year from January 1, 2019, through June 30, 2019,
under Sec. 425.200(b)(2)(ii)(B), CMS reconciles the ACO for the period
from January 1, 2019, through June 30, 2019, after the conclusion of CY
2019, based on the 12-month calendar year and pro-rates shared savings
or shared losses to reflect the ACO's participation from January 1,
2019, through June 30, 2019. CMS does all of the following to determine
financial and quality performance:
(1) Uses the ACO participant list in effect for the performance
year beginning January 1, 2019, to determine beneficiary assignment,
using claims for the entire calendar year, as specified in Sec. Sec.
425.402 and 425.404, and according to the ACO's track as specified in
Sec. 425.400.
(i) For ACOs under preliminary prospective assignment with
retrospective reconciliation the assignment window is CY 2019.
(ii) For ACOs under prospective assignment--
(A) Medicare fee-for-service beneficiaries are prospectively
assigned to the ACO based on the beneficiary's use of primary care
services in the most recent 12 months for which data are available; and
(B) Beneficiaries remain prospectively assigned to the ACO at the
end of CY 2019 if they do not meet any of the exclusion criteria under
Sec. 425.401(b) during the calendar year.
(2) Uses the ACO's quality performance for the 2019 reporting
period to determine the ACO's quality performance score as specified in
Sec. 425.502. The ACO's latest certified ACO participant list is used
to determine the quality reporting samples for the 2019 reporting year
for an ACO that extends its participation agreement for the 6-month
performance year from January 1, 2019, through June 30, 2019, under
Sec. 425.200(b)(2)(ii)(B).
(3) Uses the methodology for calculating shared savings or shared
losses applicable to the ACO under the terms of the participation
agreement that was in effect on January 1, 2019.
(i) The ACO's historical benchmark is determined according to
either Sec. 425.602 (first agreement period) or Sec. 425.603 (second
agreement period) except as follows:
(A) The benchmark is adjusted for changes in severity and case mix
between BY3 and CY 2019 using the methodology that accounts separately
for newly and continuously assigned beneficiaries using prospective HCC
risk scores and demographic factors as described under Sec. Sec.
425.604(a)(1) through (3), 425.606(a)(1) through (3), and 425.610(a)(1)
through (3).
(B) The benchmark is updated to CY 2019 according to the
methodology described under Sec. 425.602(b), Sec. 425.603(b), or
Sec. 425.603(d), based on whether the ACO is in its first or second
agreement period, and for an ACO in a second agreement period, the date
on which that agreement period began.
(ii) The ACO's financial performance is determined based on the
track the ACO is participating under during the performance year
starting on January 1, 2019 (Sec. 425.604, Sec. 425.606 or Sec.
425.610), unless otherwise specified. In determining ACO financial
performance, CMS does all of the following:
(A) Average per capita Medicare Parts A and B fee-for-service
expenditures for CY 2019 are calculated for the ACO's performance year
assigned beneficiary population identified in paragraph (b)(1) of this
section.
(B) Expenditures calculated in paragraph (b)(3)(ii)(A) of this
section are compared to the ACO's updated benchmark determined
according to paragraph (b)(3)(i) of this section.
(C)(1) The ACO's performance year assigned beneficiary population
identified in paragraph (b)(1) of this section is used to determine the
MSR for Track 1 ACOs and the variable MSR/MLR for ACOs in a two-sided
model that selected this option at the start of their agreement period.
For two-sided model ACOs that selected a fixed MSR/MLR at the start of
the ACO's agreement period, this fixed MSR/MLR is applied. In the event
an ACO's performance year assigned population identified in paragraph
(b)(1) of this section is below 5,000 beneficiaries, the MSR/MLR is
determined according to Sec. 425.110(b).
(2) To qualify for shared savings an ACO must do all of the
following:
(i) Have average per capita Medicare Parts A and B fee-for-service
expenditures for its assigned beneficiary population for CY 2019 below
its updated benchmark costs for the year by at least the MSR
established for the ACO based on the track the ACO is participating
under during the performance year starting on January 1, 2019 (Sec.
425.604, Sec. 425.606 or Sec. 425.610) and paragraph (b)(3)(ii)(C)(1)
of this section.
(ii) Meet the minimum quality performance standards established
under Sec. 425.502 and according to paragraph (b)(2) of this section.
(iii) Otherwise maintain its eligibility to participate in the
Shared Savings Program under this part.
(3) To be responsible for sharing losses with the Medicare program,
an ACO's average per capita Medicare Parts A and B fee-for-service
expenditures for its assigned beneficiary population for CY 2019 must
be above its updated benchmark costs for the year by at least the MLR
established for the ACO based on the track the ACO is participating
under during the performance year starting on January 1, 2019 (Sec.
425.606 or Sec. 425.610) and paragraph (b)(3)(ii)(C)(1) of this
section.
(D) For an ACO that meets all the requirements to receive a shared
savings payment under paragraph (b)(3)(ii)(C)(2) of this section--
(1) The final sharing rate, determined based on the track the ACO
is participating under during the performance year starting on January
1, 2019 (Sec. 425.604, Sec. 425.606 or Sec. 425.610), is applied to
all savings under the updated benchmark specified under paragraph
(b)(3)(i) of this section, not to exceed the performance payment limit
for the ACO based on its track; and
(2) After applying the applicable performance payment limit, CMS
pro-rates any shared savings amount determined under paragraph
(b)(3)(ii)(D)(1) of this section by multiplying the amount by one-half,
which represents the fraction of the calendar year covered by the
period from January 1, 2019, through June 30, 2019.
(E) For an ACO responsible for shared losses under paragraph
(b)(3)(ii)(C)(3) of this section--
(1) The shared loss rate, determined based on the track the ACO is
participating under during the performance year starting on January 1,
2019 (Sec. 425.606 or Sec. 425.610), is applied to all losses under
the updated benchmark specified under paragraph (b)(3)(i) of this
section, not to exceed the loss recoupment limit for the ACO based on
its track; and
(2) After applying the applicable loss recoupment limit, CMS pro-
rates any shared losses amount determined under paragraph
(b)(3)(ii)(E)(1) of this section by multiplying the amount by one-half,
which represents the fraction of the calendar year covered by the
period from January 1, 2019, through June 30, 2019.
(c) [Reserved]
(d) Extreme and uncontrollable circumstances. For ACOs affected by
extreme and uncontrollable circumstances during CY 2019--

[[Page 60096]]

(1) In calculating the amount of shared losses owed, CMS makes
adjustments to the amount determined in paragraph (b)(3)(ii)(E)(1) of
this section, as specified in Sec. 425.606(i) or Sec. 425.610(i), as
applicable; and
(2) In determining the ACO's quality performance score for the 2019
quality reporting period, CMS uses the alternative scoring methodology
specified in Sec. 425.502(f).
(e) Notification of savings and losses. CMS notifies the ACO of
shared savings or shared losses for the January 1, 2019 through June
30, 2019 performance year, consistent with the notification
requirements specified in Sec. Sec. 425.604(f), 425.606(h), and
425.610(h), as applicable:
(1) CMS notifies an ACO in writing regarding whether the ACO
qualifies for a shared savings payment, and if so, the amount of the
payment due.
(2) CMS provides written notification to an ACO of the amount of
shared losses, if any, that it must repay to the program.
(3) If an ACO has shared losses, the ACO must make payment in full
to CMS within 90 days of receipt of notification.

0
67. Section 425.610 is amended--
0
a. In paragraph (i) introductory text by removing the phrase ``For
performance year 2017'' and adding in its place the phrase ``For
performance year 2017 and subsequent performance years'';
0
b. In paragraph (i)(1) by removing the phrase ``2017''; and
0
c. By adding paragraph (j).
The addition reads as follows:

Sec. 425.610 Calculation of shared savings and losses under Track 3.

* * * * *
(j) January 1, 2019 through June 30, 2019 performance year. Shared
savings or shared losses for the January 1, 2019 through June 30, 2019
performance year are calculated as described in Sec. 425.609.

0
68. Section 425.702 is amended by adding paragraph (d) to read as
follows:

Sec. 425.702 Aggregate reports.

* * * * *
(d) For an ACO eligible to be reconciled under Sec. 425.609(b),
CMS shares with the ACO quarterly aggregate reports as provided in
paragraphs (b) and (c)(1)(ii) of this section for CY 2019.

PART 495--STANDARDS FOR THE ELECTRONIC HEALTH RECORD TECHNOLOGY
INCENTIVE PROGRAM

0
69. The authority citation for part 495 is revised to read as follows:

Authority: 42 U.S.C. 1302 and 1395hh.

0
70. Section 495.4 is amended in the definition of ``EHR reporting
period'' by adding paragraph (1)(v) to read as follows:

Sec. 495.4 Definitions.

* * * * *
EHR reporting period. * * *
(1) * * *
(v) Under the Medicaid Promoting Interoperability Program, for the
CY 2021 payment year:
(A) For the EP first demonstrating he or she is a meaningful EHR
user, any continuous 90-day period within CY 2021 that ends before
October 31, 2021, or that ends before an earlier date in CY 2021 that
is specified by the state and approved by CMS in the State Medicaid HIT
plan described at Sec. 495.332.
(B) For the EP who has successfully demonstrated he or she is a
meaningful EHR user in any prior year, any continuous 90-day period
within CY 2021 that ends before October 31, 2021, or that ends before
an earlier date in CY 2021 that is specified by the state and approved
by CMS in the State Medicaid HIT plan described at Sec. 495.332.
* * * * *

0
71. Section 495.24 is amended by revising paragraphs (d)(6)(i)(B) and
(d)(8)(i)(B)(2) to read as follows:

Sec. 495.24 Stage 3 meaningful use objectives and measures for EPs,
eligible hospitals and CAHs for 2019 and subsequent years.

* * * * *
(d) * * *
(6) * * *
(i) * * *
(B) Measures. In accordance with paragraph (a)(2) of this section,
an EP must satisfy 2 out of the 3 following measures in paragraphs
(d)(6)(i)(B)(1) through (3) of this section except those measures for
which an EP qualifies for an exclusion under paragraph (a)(3) of this
section.
(1) During the EHR reporting period, more than 5 percent of all
unique patients (or their authorized representatives) seen by the EP
actively engage with the electronic health record made accessible by
the provider and do either of the following:
(i) View, download or transmit to a third party their health
information;
(ii) Access their health information through the use of an API that
can be used by applications chosen by the patient and configured to the
API in the provider's CEHRT; or
(iii) A combination of paragraphs (d)(6)(i)(B)(1)(i) and (ii) of
this section.
(2) A secure message was sent using the electronic messaging
function of CEHRT to the patient (or their authorized representatives),
or in response to a secure message sent by the patient, for more than 5
percent of all unique patients seen by the EP during the EHR reporting
period.
(3) Patient generated health data or data from a nonclinical
setting is incorporated into the CEHRT for more than 5 percent of all
unique patients seen by the EP during the EHR reporting period.
* * * * *
(8) * * *
(i) * * *
(B) * * *
(2) Syndromic surveillance reporting. The EP is in active
engagement with a public health agency to submit syndromic surveillance
data from an urgent care setting, or from any other setting from which
ambulatory syndromic surveillance data are collected by the state or a
local public health agency.
* * * * *

0
72. Section 495.332 is amended by adding paragraphs (f)(3), (4), and
(5) to read as follows:

Sec. 495.332 State Medicaid health information technology (HIT) plan
requirements.

* * * * *
(f) * * *
(3) An alternative date within CY 2021 by which all ``EHR reporting
periods'' (as defined under Sec. 495.4) for the CY 2021 payment year
for Medicaid EPs demonstrating they are meaningful EHR users must end.
The alternative date selected by the state must be earlier than October
31, 2021, and must not be any earlier than the day prior to the
attestation deadline for Medicaid EPs attesting to that state.
(4) An alternative date within CY 2021 by which all clinical
quality measure reporting periods for the CY 2021 payment year for
Medicaid EPs demonstrating they are meaningful EHR users must end. The
alternative date selected by the state must be earlier than October 31,
2021, and must not be any earlier than the day prior to the attestation
deadline for Medicaid EPs attesting to that state.
(5) For the CY 2019 payment year and beyond, a state-specific
listing of which clinical quality measures selected by CMS are
considered to be high priority measures for purposes of Medicaid EP
clinical quality measure reporting.
* * * * *

[[Page 60097]]

Dated: October 26, 2018.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
Dated: October 30, 2018.
Alex M. Azar II,
Secretary, Department of Health and Human Services.

Appendix 1: Finalized MIPS Quality Measures

Note: Except as otherwise finalized in this final rule,
previously finalized measures and specialty measure sets will
continue to apply for the 2021 MIPS payment year and future years.

BILLING CODE 4120-01-P
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[FR Doc. 2018-24170 Filed 11-1-18; 4:15 pm]
BILLING CODE 4120-01-C

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