Justia Department Of Health And Human Services Centers For Medicare & Medicaid Services Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; New Categories for Hospital Outpatient Department Prior Authorization Process; Clinical Laboratory Fee Schedule: Laboratory Date of Service Policy; Overall Hospital Quality Star Rating Methodology; Physician-Owned Hospitals; Notice of Closure of Two Teaching Hospitals and Opportunity To Apply for Available Slots; Radiation Oncology Model; and Reporting Requirements for Hospitals and Critical Access Hospitals (CAHs) to Report COVID-19 Therapeutic Inventory and Usage and To Report Acute Respiratory Illness During the Public Health Emergency (PHE) for Coronavirus Disease 2019 (COVID-19); Correction, 11428-11432 [2021-03852]

Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; New Categories for Hospital Outpatient Department Prior Authorization Process; Clinical Laboratory Fee Schedule: Laboratory Date of Service Policy; Overall Hospital Quality Star Rating Methodology; Physician-Owned Hospitals; Notice of Closure of Two Teaching Hospitals and Opportunity To Apply for Available Slots; Radiation Oncology Model; and Reporting Requirements for Hospitals and Critical Access Hospitals (CAHs) to Report COVID-19 Therapeutic Inventory and Usage and To Report Acute Respiratory Illness During the Public Health Emergency (PHE) for Coronavirus Disease 2019 (COVID-19); Correction, 11428-11432 [2021-03852]

Download as PDF 11428 Federal Register / Vol. 86, No. 36 / Thursday, February 25, 2021 / Rules and Regulations see the ADDRESSES section of this preamble. G. Protest Activities The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to call or email the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels. List of Subjects in 33 CFR Part 165 (d) Enforcement period. This section will be enforced from 9:30 a.m. until 10:30 a.m. on February 26, 2021. The back up dates will be February 27, 2021 or February 28, 2021, from 9:30 a.m. until 10:30 a.m. (e) Informational broadcasts. The COTP or a designated representative will inform the public through Broadcast Notices to Mariners and the Local Notice to Mariners of the enforcement period for the temporary safety zone as well as any changes in the planned schedule. Dated: February 19, 2021. A.M. Beach, Captain, U.S. Coast Guard, Captain of the Port Sector Ohio Valley. Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways. For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows: [FR Doc. 2021–03974 Filed 2–24–21; 8:45 am] BILLING CODE 9110–04–P PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS DEPARTMENT OF HEALTH AND HUMAN SERVICES 1. The authority citation for part 165 continues to read as follows: Centers for Medicare & Medicaid Services Authority: 46 U.S.C. 70034, 70051; 33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; Department of Homeland Security Delegation No. 0170.1. 42 CFR Parts 410, 411, 412, 414, 416, 419, 482, 485, 512 2. Add § 165.T08–0098 to read as follows: RIN 0938–AU12 ■ ■ § 165.T08–0098 Safety Zone; Ohio River, New Richmond, OH. (a) Location. The following area is a temporary safety zone: All navigable waters of the Ohio River between MM 452.0 to MM 454.0 in New Richmond, OH. (b) Definitions. As used in this section, designated representative means a Coast Guard Patrol Commander, including a Coast Guard coxswain, petty officer, or other officer operating a Coast Guard vessel and a Federal, State, and local officer designated by or assisting the Captain of the Port Sector Ohio Valley (COTP) in the enforcement of the safety zone. (c) Regulations. (1) In accordance with the general regulations in § 165.23, entry into this zone is prohibited unless specifically authorized by the Captain of the Port Sector Ohio Valley (COTP) or a designated representative. Persons or vessels desiring to enter into or pass through the zone must request permission from the COTP or a designated representative. They may be contacted on VHF–FM radio channel 16 or phone at 1–800–253–7465. (2) Persons and vessels permitted to enter this safety zone must transit at the slowest safe speed and comply with all lawful directions issued by the COTP or a designated representative. VerDate Sep<11>2014 16:18 Feb 24, 2021 Jkt 253001 [CMS–1736–CN] Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; New Categories for Hospital Outpatient Department Prior Authorization Process; Clinical Laboratory Fee Schedule: Laboratory Date of Service Policy; Overall Hospital Quality Star Rating Methodology; Physician-Owned Hospitals; Notice of Closure of Two Teaching Hospitals and Opportunity To Apply for Available Slots; Radiation Oncology Model; and Reporting Requirements for Hospitals and Critical Access Hospitals (CAHs) to Report COVID–19 Therapeutic Inventory and Usage and To Report Acute Respiratory Illness During the Public Health Emergency (PHE) for Coronavirus Disease 2019 (COVID–19); Correction Centers for Medicare & Medicaid Services (CMS), Health and Human Services (HHS). ACTION: Final rule with comment period and interim final rule; correction. AGENCY: This document corrects technical and typographical errors in the final rule with comment period and interim final rule with comment period published in the Federal Register on December 29, 2020, titled ‘‘Hospital SUMMARY: PO 00000 Frm 00042 Fmt 4700 Sfmt 4700 Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; New Categories for Hospital Outpatient Department Prior Authorization Process; Clinical Laboratory Fee Schedule: Laboratory Date of Service Policy; Overall Hospital Quality Star Rating Methodology; Physician-owned Hospitals; Notice of Closure of Two Teaching Hospitals and Opportunity To Apply for Available Slots; Radiation Oncology Model; and Reporting Requirements for Hospitals and Critical Access Hospitals (CAHs) to Report COVID–19 Therapeutic Inventory and Usage and to Report Acute Respiratory Illness During the Public Health Emergency (PHE) for Coronavirus Disease 2019 (COVID–19)’’. DATES: Effective date: This correction is effective February 25, 2021. Applicability date: The corrections in this correcting document are applicable beginning January 1, 2021. FOR FURTHER INFORMATION CONTACT: Elise Barringer via email Elise.Barringer@cms.hhs.gov or at (410) 786–9222. SUPPLEMENTARY INFORMATION: I. Background In FR Doc. 2020–26819 of December 29, 2020 (85 FR 85866), there were a number of technical and typographical errors that are identified and corrected in the Correction of Errors section below. The corrections in this correction document are applicable as if they had been included in the document that was issued on December 4, 2020, and published December 29, 2020. Accordingly, each correction is applicable on January 1, 2021. II. Summary of Errors A. Summary of Errors in the Preamble 1. Hospital Outpatient Prospective Payment System (OPPS) Corrections On page 85987 of the ‘‘OPPS APCSpecific Policies’’ section, we inadvertently omitted a summary of a public comment and response related to existing CPT codes 0607T and 0608T. Therefore, we are adding a new subsection titled ‘‘31. Other Procedures/ Services’’ that includes a summary of this public comment and our response. On page 86033, we are correcting an inadvertent reference to the quarter for which ASP data will be used to calculate payment rates for HCPCS codes for separately payable drugs and biologicals included in Addenda A and B: It is the second quarter of CY 2020, not the third quarter of CY 2020. On Page 86035, we inadvertently referred to CY 2018, rather than CY E:\FR\FM\25FER1.SGM 25FER1 Federal Register / Vol. 86, No. 36 / Thursday, February 25, 2021 / Rules and Regulations 2021, as the year in which the proposed packaging status of each drug and biological with HCPCS codes that describe different dosages of the same drug or biological would apply. On Page 86063, in Table 42: Skin Substitute Assignments to High Cost and Low Cost Groups for CY 2021, we inadvertently stated in the column titled ‘‘Final CY 2021 High/Low Cost Assignment’’ that HCPCS code Q4222 is assigned to the ‘‘Low’’ cost group rather than ‘‘High’’ cost group. On Page 86273, we inadvertently described the increase in total OPPS payments in CY 2021 as a result of the update to the conversion factor, the CY 2021 frontier wage index adjustment, and other adjustments (not including the effects of outlier payments or the pass-through payment estimates) as 0.2 percent, rather than 2.6 percent. 2. Ambulatory Surgical Center (ASC) Payment System Corrections On pages 86154 and 86165, in Tables 59 and 60, we incorrectly listed the final CY 2021 ASC payment indicator for CPT code 0404T (Transcervical uterine fibroid(s) ablation with ultrasound guidance, radiofrequency) as ‘‘G2’’ instead of ‘‘J8’’. As stated on page 86016, we assigned device-intensive status to CPT code 0404T and finalized a default device offset percentage of 31 percent to reflect the device costs associated with that code for CY 2021. However, we inadvertently did not assign device-intensive status to CPT code 0404T or utilize the default device offset percentage under the ASC payment system for CPT code 0404T when calculating ASC payment rates for CY 2021. On page 86175, we inadvertently did not refer to the revised modifications to the labor market areas contained in OMB Bulletins 18–03 and 18–04. While we used these updated delineations to calculate the ASC wage index for CY 2021, which we used to calculate the ASC payment system rates, we unintentionally did not include conforming language in the ASC wage index section of the preamble to refer to these bulletins. Therefore, we are correcting the ASC wage index section by including language referring to the revised labor market areas issued in the OMB Bulletins 18–03 and 18–04. On pages 86176 and 86282, we are correcting references to the weight scalar used in ASC payment rate calculations from ‘‘0.8591’’ to ‘‘0.8547’’ to include the effect of our policy to unpackage HCPCS code J1097 (phenylephrine 10.16 mg/ml and ketorolac 2.88 mg/ml ophthalmic irrigation solution, 1 ml) for CY 2021 VerDate Sep<11>2014 16:18 Feb 24, 2021 Jkt 253001 (85 FR 86172). We also inadvertently omitted prospective expenditures related to HCPCS code J1097 for CY 2021 in our calculation of the ASC budget neutrality adjustment. We note that the ASC weight scalar of 0.8547 includes this correction, the correction noted above for CPT code 0404T, and accounts for the increase in CY 2021 Medicare Physician Fee Schedule payment amounts of 3.75 percent, which is required by section 101(a) of Division N, Title I of the Consolidated Appropriations Act (CAA), 2021 (Pub. L. 116–260). For office-based covered surgical procedures and certain covered ancillary radiology services and diagnostic tests under the ASC payment system, the payment rate is the lower of the final CY 2021 MPFS nonfacility PE RVU-based amount multiplied by the MPFS conversion factor or the OPPSrelative weight-based CY 2021 ASC payment amount, and accordingly, it was necessary to update the MPFSbased ASC rates for CY 2021. 3. Hospital Outpatient Quality Reporting Program Correction On page 86182, in footnote 107, the url in the following reference is corrected: ‘‘The data reviewed are maintained in the CMS Integrated Data Repository (IDR). The IDR is a high volume data warehouse integrating Medicare Parts A, B, C, and D, and DME claims, beneficiary and provider data sources, along with ancillary data such as contract information and risk scores. Additional information is available at https://www.cms.gov/ResearchStatistics-DataandSystems/ComputerData-and-Systems/IDR/.’’ The url is corrected to read: https:// www.cms.gov/Research-Statistics-Dataand-Systems/Computer-Data-andSystems/IDR. 4. Ambulatory Surgical Center Quality Reporting Program Correction On page 86192, in footnote 110, the url in the following reference is not correct: ‘‘For more information on the ECE policy, we refer stakeholders to the QualityNet website at https:// www.qualitynet.org/asc/ datasubmission#tab2.’’ The url is corrected to read: https:// www.qualitynet.org/asc/ascqr/ participation#tab2. B. Summary of Errors and Corrections to the OPPS and ASC Addenda Posted on the CMS Website 1. OPPS Addenda Posted on the CMS Website In Addendum A of the CY 2021 OPPS/ASC final rule with comment PO 00000 Frm 00043 Fmt 4700 Sfmt 4700 11429 period, APC 9370 had an incorrect payment rate of $0.752. We corrected the following: • For APC 9370 (Fluoroestradiol f 18), we included an incorrect payment rate. Specifically, we are correcting the payment rate from $0.752 to $626.583. In Addendum B of the CY 2021 OPPS/ASC final rule with comment period, HCPCS codes G2061, G2062, and G2063 are incorrectly shown as active codes with status indicator ‘‘A’’ to indicate that they should be paid under a fee schedule or payment system other than the OPPS. These codes have been deleted effective December 31, 2020, and therefore should be assigned status indicator ‘‘D’’ to indicate that they are discontinued codes. These codes have been replaced with CPT codes 98970, 98971, and 98972, respectively. CPT codes 98970, 98971, and 98972 were incorrectly assigned to status indicator ‘‘B’’ to indicate that another more appropriate code should be reported. But because these codes are replacing HCPCS codes G2061, G2062, and G2063, they should be assigned status indicator ‘‘A’’. Therefore, in the Addendum B (Final OPPS Payment by HCPCS code for CY 2021), we corrected the following: • HCPCS code G2061 (Qual nonmd est pt 5–10m): We made a typographical error in the status indicator assignment. Specifically, we are correcting the status indicator from ‘‘A’’ to ‘‘D’’. • HCPCS code G2062 (Qual nonmd est pt 11–20m): We made a typographical error in the status indicator assignment. Specifically, we are correcting the status indicator from ‘‘A’’ to ‘‘D’’. • HCPCS code G2063 (Qual nonmd est pt 21>min): We made a typographical error in the status indicator assignment. Specifically, we are correcting the status indicator from ‘‘A’’ to ‘‘D’’. • CPT code 98970 (Qnhp ol dig assmt&mgmt 5–10): We made a typographical error in the status indicator assignment. Specifically, we are correcting the status indicator from ‘‘B’’ to ‘‘A’’. We are also assigning 98970 to comment indicator ‘‘CH’’ to indicate that its status indicator has changed. • CPT code 98971 (Qnhp ol dig assmt&mgmt 11–20): We made a typographical error in the status indicator assignment. Specifically, we are correcting the status indicator from ‘‘B’’ to ‘‘A’’. We are also assigning 98971 to comment indicator ‘‘CH’’ to indicate that its status indicator has changed. • CPT code 98972 (Qnhp ol dig assmt&mgmt 21+): We made a typographical error in the status indicator assignment. Specifically, we E:\FR\FM\25FER1.SGM 25FER1 11430 Federal Register / Vol. 86, No. 36 / Thursday, February 25, 2021 / Rules and Regulations are correcting the status indicator from ‘‘B’’ to ‘‘A’’. We are also assigning 98972 to comment indicator ‘‘CH’’ to indicate that its status indicator has changed. In Addendum B of the CY 2021 OPPS/ASC final rule with comment period, HCPCS codes G2010 and G2012 were incorrectly assigned to status indicator ‘‘A’’ to indicate that they should be paid under a fee schedule or payment system other than the OPPS. However, because these codes were replaced with HCPCS codes G2250 and G2251 for certain non-physician practitioners, including rehabilitation therapists, effective January 1, 2021, we assigned them to status indicator ‘‘B’’ under the OPPS to indicate that other more appropriate codes should be reported. Therefore, in the Addendum B (Final OPPS Payment by HCPCS code for CY 2021), we corrected the following: • HCPCS code G2010 (Remote evaluation of recorded video and/or images submitted by an established patient (e.g., store and forward), including interpretation with follow-up with the patient within 24 business hours, not originating from a related e/ m service provided within the previous 7 days nor leading to an e/m service or procedure within the next 24 hours or soonest available appointment). We made a typographical error in the status indicator assignment. Specifically, we are correcting the status indicator from ‘‘A’’ to ‘‘B’’. • HCPCS code G2012 (Brief communication technology-based service, e.g., virtual check-in, by a physician or other qualified health care professional who can report evaluation and management services, provided to an established patient, not originating from a related e/m service provided within the previous 7 days nor leading to an e/m service or procedure within the next 24 hours or soonest available appointment; 5–10 minutes of medical discussion). We made a typographical error in the status indicator assignment. Specifically, we are correcting the status indicator from ‘‘A’’ to ‘‘B’’. In Addendum B of the CY 2021 OPPS/ASC final rule with comment period, HCPCS code G2211 was incorrectly assigned to status indicator ‘‘N’’ to indicate that it should be packaged under the OPPS. We intended to assign this code to status indicator ‘‘B’’ to indicate that it should not be payable under the OPPS because this code is an add-on code to existing Evaluation and Management code(s) that are assigned to status indicator ‘‘B’’. Therefore, in the Addendum B (Final OPPS Payment by HCPCS code for CY 2021), we corrected the following: VerDate Sep<11>2014 16:18 Feb 24, 2021 Jkt 253001 • HCPCS code G2211 (Visit complexity inherent to evaluation and management associated with medical care services that serve as the continuing focal point for all needed health care services and/or with medical care services that are part of ongoing care related to a patient’s single, serious condition or a complex condition. (addon code, list separately in addition to office/outpatient evaluation and management visit, new or established)). We made a typographical error in the status indicator assignment. Specifically, we are correcting the status indicator from ‘‘N’’ to ‘‘B’’. In Addendum B of the CY 2021 OPPS/ASC final rule with comment period, HCPCS code A9591 had an incorrect payment rate of $0.752. We corrected the following: • For HCPCS A9591 (Fluoroestradiol f 18, diagnostic, 1 millicurie), we included an incorrect payment rate. Specifically, we are correcting the payment rate from $0.752 to $626.583. In Addendum C of the CY 2021 OPPS/ASC final rule with comment period, APC 9370, HCPCS code A9591 had an incorrect payment rate of $0.752. We corrected the following: • For APC 9370 (Fluoroestradiol f 18), HCPCS code A9591 (Fluoroestradiol f 18, diagnostic, 1 millicurie), we included an incorrect payment rate. Specifically, we are correcting the payment rate from $0.752 to $626.583. In Addendum P, in the tab titled ‘‘2021 FR Device Intensive List’’, we inadvertently omitted CPT code 0404T from this list. CPT code 0404T was finalized as a device-intensive procedure for CY 2021 with a device offset percentage of 31 percent. We have added this procedure to the list of device-intensive procedures on this tab in Addendum P. To view the corrected CY 2021 OPPS status indicators, comment indicators, APC assignments, relative weights, payment rates, copayment rates, deviceintensive status, and short descriptors in Addenda A, B, C, and P, we refer readers to the Addenda and supporting files that are posted on the CMS website at: https://www.cms.gov/Medicare/ Medicare-Fee-for-Service-Payment/ HospitalOutpatientPPS/. Select ‘‘CMS–1736–CN’’ from the list of regulations. All corrected Addenda for this correcting document are contained in the zipped folder titled ‘‘2021 OPPS Final Rule Addenda’’ at the bottom of the page for CMS–1736–CN. 2. ASC Payment System Addenda Posted on the CMS Website In Addenda AA and BB, we inadvertently applied an incorrect ASC PO 00000 Frm 00044 Fmt 4700 Sfmt 4700 weight scalar to calculate payment rates under the ASC payment system. In our CY 2021 OPPS/ASC final rule with comment period, we finalized a policy to unpackage HCPCS code J1097 (phenylephrine 10.16 mg/ml and ketorolac 2.88 mg/ml ophthalmic irrigation solution, 1 ml) for CY 2021 (85 FR 86172). However, in our budget neutrality adjustment calculation, we inadvertently omitted prospective expenditures related to J1097 for CY 2021. This error impacted the calculation of the ASC weight scalar and ASC payment rates. Accordingly, we have updated Addenda AA and BB to accurately reflect the ASC payment rates based on the revised ASC weight scalar, as corrected in this notice and updated to include the increased MPFS rates required by section 101(a) of Division N, Title I of the Consolidated Appropriations Act, 2021. In Addendum BB of the CY 2021 OPPS/ASC final rule with comment period, HCPCS code A9591 had an incorrect payment rate of $0.75. We corrected the following: • For HCPCS A9591 (Fluoroestradiol f 18, diagnostic, 1 millicurie), we included an incorrect payment rate. Specifically, we are correcting the payment rate from $0.75 to $626.58. To view the corrected final CY 2021 ASC payment indicators, payment weights, payment rates, and multiple procedure discounting indicator in Addenda AA and BB, we refer readers to the Addenda and supporting files on the CMS website at: https:// www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/ASCPayment/ASCRegulations-and-Notices.html. Select ‘‘CMS–1736–CN’’ from the list of regulations. All corrected ASC addenda for this correcting document are contained in the zipped folder titled ‘‘Addendum AA, BB, DD1, DD2, and EE’’ at the bottom of the page for CMS– 1736–CN. III. Waiver of Proposed Rulemaking, 60-Day Comment Period, and Delay in Effective Date Under 5 U.S.C. 553(b) of the Administrative Procedure Act (APA), the agency is required to publish a notice of proposed rulemaking in the Federal Register before the provisions of a rule take effect. Similarly, section 1871(b)(1) of the Act requires the Secretary to provide notice of the proposed rulemaking in the Federal Register and a period of not less than 60 days for public comment. In addition, section 553(d) of the APA and section 1871(e)(1)(B)(i) of the Act mandate a 30day delay in effective date after issuance or publication of a rule. Sections E:\FR\FM\25FER1.SGM 25FER1 Federal Register / Vol. 86, No. 36 / Thursday, February 25, 2021 / Rules and Regulations 553(b)(B) and 553(d)(3) of the APA provide for exceptions from the notice and comment and delay in effective date APA requirements; in cases in which these exceptions apply, sections 1871(b)(2)(C) and 1871(e)(1)(B)(ii) of the Act provide exceptions from the notice and 60-day comment period and delay in effective date requirements of the Act as well. Section 553(b)(B) of the APA and section 1871(b)(2)(C) of the Act authorize an agency to dispense with normal rulemaking requirements for good cause if the agency makes a finding that the notice and comment process are impracticable, unnecessary, or contrary to the public interest. In addition, both sections 553(d)(3) of the APA and section 1871(e)(1)(B)(ii) of the Act allow the agency to avoid the 30day delay in effective date where such delay is contrary to the public interest and an agency includes a statement of support. We believe that this correcting document does not constitute a rule that would be subject to the notice and comment or delayed effective date requirements. This document corrects technical and typographic errors in the preamble, addenda, payment rates, tables, and appendices included or referenced in the CY 2021 OPPS/ASC final rule with comment period, but does not make substantive changes to the policies or payment methodologies that were adopted in the final rule with comment period. As a result, this correcting document is intended to ensure that the information in the CY 2021 OPPS/ASC final rule with comment period accurately reflects the policies adopted in that document. In addition, even if this were a rule to which the notice and comment procedures and delayed effective date requirements applied, we find that there is good cause to waive such requirements. Undertaking further notice and comment procedures to incorporate the corrections in this document into the final rule or delaying the effective date would be contrary to the public interest because it is in the public’s interest for providers to receive appropriate payments in as timely a manner as possible, and to ensure that the CY 2021 OPPS/ASC final rule accurately reflects our policies as of the date they take effect and are applicable. Furthermore, such procedures would be unnecessary, as we are not altering our payment methodologies or policies, but rather, we are simply correctly implementing the policies that we previously proposed, received comment on, and subsequently finalized. This correcting document is intended solely to ensure that the CY 2021 OPPS/ASC VerDate Sep<11>2014 16:18 Feb 24, 2021 Jkt 253001 final rule with comment period accurately reflects these payment methodologies and policies. For these reasons, we believe we have good cause to waive the notice and comment and effective date requirements. Moreover, even if these corrections were considered to be retroactive rulemaking, they would be authorized under section 1871(e)(1)(A)(ii) of the Act, which permits the Secretary to issue a rule for the Medicare program with retroactive effect if the failure to do so would be contrary to the public interest. As we have explained previously, we believe it would be contrary to the public interest not to implement the corrections in this correcting document because it is in the public’s interest for providers to receive appropriate payments in as timely a manner as possible, and to ensure that the CY 2021 OPPS/ASC final rule with comment period accurately reflects our policies. IV. Correction of Errors In FR Doc. 2020–26819 of December 29, 2020 (85 FR 85866), make the following corrections: 1. On page 85987, third column, after the second full paragraph ending with ‘‘Addendum B is available via the internet on the CMS website.’’ and before the section titled ‘‘IV. OPPS Payment for Devices,’’ the following section and text are added: 31. Other Procedures/Services For CY 2021, we proposed to continue to assign CPT code 0607T to APC 5012 (Clinic Visits and Related Services) with status indicator ‘‘V’’ (Clinic or Emergency Department Visit. Paid under OPPS; separate APC payment) and a proposed payment rate of $120.88. In addition, we proposed to continue to assign CPT code 0608T to APC 5741 (Level 1 Electronic Analysis of Devices) with status indicator ‘‘S’’ (Procedure or Service, Not Discounted When Multiple. Paid under OPPS; separate APC payment) and a proposed payment rate of $37.76. Below are the long descriptors for CPT codes 0607T and 0608T: • 0607T: Remote monitoring of an external continuous pulmonary fluid monitoring system, including measurement of radiofrequency-derived pulmonary fluid levels, heart rate, respiration rate, activity, posture, and cardiovascular rhythm (e.g., ECG data), transmitted to a remote 24-hour attended surveillance center; set-up and patient education on use of equipment; and • 0608T: Remote monitoring of an external continuous pulmonary fluid monitoring system, including PO 00000 Frm 00045 Fmt 4700 Sfmt 4700 11431 measurement of radiofrequency-derived pulmonary fluid levels, heart rate, respiration rate, activity, posture, and cardiovascular rhythm (e.g., ECG data), transmitted to a remote 24-hour attended surveillance center; analysis of data received and transmission of reports to the physician or other qualified health care professional. Comment: A commenter requested that we reassign CPT codes 0607T and 0608T to non-payable OPPS status indicators because the commenter contended that the service associated with the codes is not provided to hospital outpatients during a hospital outpatient encounter. The commenter specifically requested that both codes be reassigned to either status indicator ‘‘B’’ (Codes that are not recognized by OPPS. Not paid under OPPS) or ‘‘M’’ (Items and Services Not Billable to the MAC. Not paid under OPPS) for both codes. The commenter reported that the services are prescribed by individual physicians, and are not currently provided to either hospital inpatients or outpatients, or in conjunction with any hospital service. According to the commenter, there is no hospital in the U.S. that possesses the technology to provide a remote pulmonary fluid monitoring system and further stated that ambulatory fluid monitoring system is only available through a single Independent Diagnostic Testing Facility (IDTF) in Pittsburgh, Pennsylvania. The commenter explained that an individual physician will prescribe the ambulatory fluid monitoring device for their patient and submit the medical order to the IDTF. Thereafter, the IDTF is ultimately responsible for the transmission, analysis, and creation of reports to the prescribing physician. Response: Based on our review of the codes and input from our medical advisors, the services described by CPT codes 0607T and 0608T may be provided in an HOPD setting. While the commenter has indicated that the services described by the codes are currently performed by one IDTF, we believe that the services can be performed by HOPDs. Consequently, for CY 2021, we believe that we should continue to assign these codes to APCs 5012 and 5741 so that HOPDs can be paid separately if they provide these services in the HOPD setting. Therefore, we are finalizing our proposal, without modification, to assign CPT codes 0607T and 0608T to APCs 5012 and 5741, respectively. The final CY 2021 payment rate for the codes can be found in Addendum B to this final rule with comment period (which is available via the internet on the CMS website). E:\FR\FM\25FER1.SGM 25FER1 11432 Federal Register / Vol. 86, No. 36 / Thursday, February 25, 2021 / Rules and Regulations 2. On page 86033, first column, first full paragraph, in line 5 and 6, ‘‘third quarter of CY 2020’’ is corrected to read ‘‘second quarter of CY 2020’’. 3. On page 86035, third column, first partial paragraph, in line 4, the year ‘‘CY 2018’’ is corrected to read ‘‘CY 2021’’. 4. On Page 86063, Table 42, in the entry for HCPCS code Q4222, under the column for ‘‘Final CY 2021 High/Low Cost Assignment,’’ ‘‘Low’’ is corrected to read ‘‘High’’. 5. On page 86154, Table 59, in the entry for CPT code 0404T, under the column ‘‘Final CY 2021 ASC Payment Indicator,’’ ‘‘G2’’ is corrected to read ‘‘J8’’. 6. On page 86165, Table 60, in the entry for CPT code 0404T, under the column ‘‘Final CY 2021 ASC Payment Indicator,’’ ‘‘G2’’ is corrected to read ‘‘J8’’. 7. On page 86175, third column, after the first partial paragraph, add the following text: On April 10, 2018, OMB issued OMB Bulletin No. 18–03 which superseded the August 15, 2017 OMB Bulletin No. 17–01. On September 14, 2018, OMB issued OMB Bulletin 18–04 which superseded the April 10, 2018 OMB Bulletin No. 18–03. A copy of OMB Bulletin No. 18–04 may be obtained at https://www.whitehouse.gov/wpcontent/ uploads/2018/90/Bulletin-18-04.pdf. We are utilizing the revised delineations as set forth in the April 10, 2018 OMB Bulletin No. 18–03 and the September 14, 2018 OMB Bulletin No. 18–04 to calculate the CY 2021 ASC wage index effective beginning January 1, 2021.’’ 8. On page 86176, third column, first full paragraph, in line 10, the figure ‘‘0.8591’’ is corrected to read ‘‘0.8547.’’ 9. On page 86182, in footnote 107, the url ‘‘https://www.cms.gov/ResearchStatistics-DataandSystems/ComputerData-and-Systems/IDR/’’ is corrected to read ‘‘https://www.cms.gov/ Research-Statistics-Data-and-Systems/ Computer-Data-and-Systems/IDR’’. 10. On page 86192, in footnote 110, the url ‘‘https://www.qualitynet.org/asc/ data-submission#tab2’’ is corrected to read: ‘‘https://www.qualitynet.org/asc/ ascqr/participation#tab2’’. 11. On page 86273, second column, third full paragraph, in lines 7 and 8, the figure ‘‘0.2 percent’’ is corrected to read ‘‘2.6 percent’’. 12. On page 86282, second column, in the first paragraph under ‘‘2. Estimated Effects of CY 2021 ASC Payment System Changes,’’ in line 10, the figure ‘‘0.8591’’ is corrected to read ‘‘0.8547.’’ VerDate Sep<11>2014 16:18 Feb 24, 2021 Jkt 253001 Dated: February 19, 2021. Wilma M. Robinson, Deputy Executive Secretary to the Department, Department of Health and Human Services. [FR Doc. 2021–03852 Filed 2–22–21; 8:45 am] BILLING CODE 4120–01–P FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 1 [WT Docket No. 19–71; FCC 21–10; FRS 17395] FCC Modernizes Siting Rule for Small Hub and Relay Wireless Antennas Federal Communications Commission. ACTION: Final rule. AGENCY: In this document, the Federal Communication’s Commission (‘‘Commission’’) updates its rule for over-the-air reception devices (OTARD) to expand its coverage to include hub and relay antennas that are used for the distribution of broadband-only fixed wireless services to multiple customer locations, regardless of whether they are primarily used for this purpose, provided the antennas satisfy other conditions of the OTARD rule. The Report and Order will allow fixed wireless service providers to bring faster internet speeds, lower latency, and advanced applications to rural and underserved communities in particular. DATES: Effective March 29, 2021. FOR FURTHER INFORMATION CONTACT: Georgios Leris, Georgios.Leris@fcc.gov, Competition & Infrastructure Policy Division, Wireless Telecommunications Bureau, (202) 418–1994. SUPPLEMENTARY INFORMATION: This is a summary of the Commission’s Report and Order in WT Docket No. 19–71, FCC 21–10, adopted on January 7, 2021 and released on January 7, 2021. The full text of this document is available for public inspection online at https:// docs.fcc.gov/public/attachments/FCC21-10A1.pdf. Documents will be available electronically in ASCII, Microsoft Word, and/or Adobe Acrobat. Alternative formats are available for people with disabilities (Braille, large print, electronic files, audio format, etc.), and reasonable accommodations (accessible format documents, sign language interpreters, CART, etc.) may be requested by sending an email to FCC504@fcc.gov or call the Consumer & Governmental Affairs Bureau at 202– 418–0530 (voice), 202–418–0432 (TTY). SUMMARY: PO 00000 Frm 00046 Fmt 4700 Sfmt 4700 Synopsis 1. The Commission in this document updates its rule for over-the-air reception devices (OTARD) to expand its coverage to include hub and relay antennas that are used for the distribution of broadband-only fixed wireless services to multiple customer locations, regardless of whether they are primarily used for this purpose, provided the antennas satisfy other conditions of the rule.1 By making this modest adjustment to the Commission’s rule while maintaining the other existing OTARD restrictions, it places fixed wireless broadband-only service providers on similar competitive footing with other service providers. This rule change should allow fixed wireless service providers to bring faster internet speeds, lower latency, and advanced applications—like the Internet of Things, telehealth, and remote learning—to all areas of the country, and to rural and underserved communities in particular. 2. The Commission’s OTARD rule prohibits laws, regulations, or restrictions imposed by State or local governments or private entities that impair the ability of antenna users to install, maintain, or use over-the-air reception devices. The Commission adopted the rule as directed by section 207 of the Telecommunications Act of 1996, pursuant to the Commission’s authority under section 303 of the Communications Act of 1934. The rule prohibits restrictions that unreasonably delay or prevent installation, maintenance, or use of an antenna; unreasonably increase the cost of installation, maintenance, or use of an antenna; or preclude reception of an acceptable quality signal. For the OTARD rule to apply, the antenna must be installed ‘‘on property within the exclusive use or control of the antenna user where the user has a direct or indirect ownership or leasehold interest in the property’’ upon which the antenna is located. 3. The original OTARD rule applied only to antennas used to receive video programming signals, but in the 2000 Competitive Networks First Report and Order the Commission expanded the rule to apply to ‘‘customer-end antennas 1 The Commission notes that the scope of the revisions in this Report and Order is limited and that it declines to adopt at this time any of the other proposals submitted by commenters or advanced by the Commission in its Notice of Proposed Rulemaking. See, e.g., Letter from Claude Aiken, President and CEO, WISPA, to Marlene H. Dortch, Secretary, FCC, WT Docket No. 17–79 (filed Aug. 27, 2018); Updating the Commission’s Rule for Over-the-Air Reception Devices, WT Docket No. 19– 71, Notice of Proposed Rulemaking, 34 FCC Rcd 2695 (2019) (Notice). E:\FR\FM\25FER1.SGM 25FER1

Agencies

[Federal Register Volume 86, Number 36 (Thursday, February 25, 2021)]
[Rules and Regulations]
[Pages 11428-11432]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03852]


=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 410, 411, 412, 414, 416, 419, 482, 485, 512

[CMS-1736-CN]
RIN 0938-AU12


Medicare Program: Hospital Outpatient Prospective Payment and 
Ambulatory Surgical Center Payment Systems and Quality Reporting 
Programs; New Categories for Hospital Outpatient Department Prior 
Authorization Process; Clinical Laboratory Fee Schedule: Laboratory 
Date of Service Policy; Overall Hospital Quality Star Rating 
Methodology; Physician-Owned Hospitals; Notice of Closure of Two 
Teaching Hospitals and Opportunity To Apply for Available Slots; 
Radiation Oncology Model; and Reporting Requirements for Hospitals and 
Critical Access Hospitals (CAHs) to Report COVID-19 Therapeutic 
Inventory and Usage and To Report Acute Respiratory Illness During the 
Public Health Emergency (PHE) for Coronavirus Disease 2019 (COVID-19); 
Correction

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

ACTION: Final rule with comment period and interim final rule; 
correction.

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

SUMMARY: This document corrects technical and typographical errors in 
the final rule with comment period and interim final rule with comment 
period published in the Federal Register on December 29, 2020, titled 
``Hospital Outpatient Prospective Payment and Ambulatory Surgical 
Center Payment Systems and Quality Reporting Programs; New Categories 
for Hospital Outpatient Department Prior Authorization Process; 
Clinical Laboratory Fee Schedule: Laboratory Date of Service Policy; 
Overall Hospital Quality Star Rating Methodology; Physician-owned 
Hospitals; Notice of Closure of Two Teaching Hospitals and Opportunity 
To Apply for Available Slots; Radiation Oncology Model; and Reporting 
Requirements for Hospitals and Critical Access Hospitals (CAHs) to 
Report COVID-19 Therapeutic Inventory and Usage and to Report Acute 
Respiratory Illness During the Public Health Emergency (PHE) for 
Coronavirus Disease 2019 (COVID-19)''.

DATES: Effective date: This correction is effective February 25, 2021.
    Applicability date: The corrections in this correcting document are 
applicable beginning January 1, 2021.

FOR FURTHER INFORMATION CONTACT: Elise Barringer via email 
[email protected] or at (410) 786-9222.

SUPPLEMENTARY INFORMATION:

I. Background

    In FR Doc. 2020-26819 of December 29, 2020 (85 FR 85866), there 
were a number of technical and typographical errors that are identified 
and corrected in the Correction of Errors section below. The 
corrections in this correction document are applicable as if they had 
been included in the document that was issued on December 4, 2020, and 
published December 29, 2020. Accordingly, each correction is applicable 
on January 1, 2021.

II. Summary of Errors

A. Summary of Errors in the Preamble

1. Hospital Outpatient Prospective Payment System (OPPS) Corrections
    On page 85987 of the ``OPPS APC-Specific Policies'' section, we 
inadvertently omitted a summary of a public comment and response 
related to existing CPT codes 0607T and 0608T. Therefore, we are adding 
a new subsection titled ``31. Other Procedures/Services'' that includes 
a summary of this public comment and our response.
    On page 86033, we are correcting an inadvertent reference to the 
quarter for which ASP data will be used to calculate payment rates for 
HCPCS codes for separately payable drugs and biologicals included in 
Addenda A and B: It is the second quarter of CY 2020, not the third 
quarter of CY 2020.
    On Page 86035, we inadvertently referred to CY 2018, rather than CY

[[Page 11429]]

2021, as the year in which the proposed packaging status of each drug 
and biological with HCPCS codes that describe different dosages of the 
same drug or biological would apply.
    On Page 86063, in Table 42: Skin Substitute Assignments to High 
Cost and Low Cost Groups for CY 2021, we inadvertently stated in the 
column titled ``Final CY 2021 High/Low Cost Assignment'' that HCPCS 
code Q4222 is assigned to the ``Low'' cost group rather than ``High'' 
cost group.
    On Page 86273, we inadvertently described the increase in total 
OPPS payments in CY 2021 as a result of the update to the conversion 
factor, the CY 2021 frontier wage index adjustment, and other 
adjustments (not including the effects of outlier payments or the pass-
through payment estimates) as 0.2 percent, rather than 2.6 percent.
2. Ambulatory Surgical Center (ASC) Payment System Corrections
    On pages 86154 and 86165, in Tables 59 and 60, we incorrectly 
listed the final CY 2021 ASC payment indicator for CPT code 0404T 
(Transcervical uterine fibroid(s) ablation with ultrasound guidance, 
radiofrequency) as ``G2'' instead of ``J8''. As stated on page 86016, 
we assigned device-intensive status to CPT code 0404T and finalized a 
default device offset percentage of 31 percent to reflect the device 
costs associated with that code for CY 2021. However, we inadvertently 
did not assign device-intensive status to CPT code 0404T or utilize the 
default device offset percentage under the ASC payment system for CPT 
code 0404T when calculating ASC payment rates for CY 2021.
    On page 86175, we inadvertently did not refer to the revised 
modifications to the labor market areas contained in OMB Bulletins 18-
03 and 18-04. While we used these updated delineations to calculate the 
ASC wage index for CY 2021, which we used to calculate the ASC payment 
system rates, we unintentionally did not include conforming language in 
the ASC wage index section of the preamble to refer to these bulletins. 
Therefore, we are correcting the ASC wage index section by including 
language referring to the revised labor market areas issued in the OMB 
Bulletins 18-03 and 18-04.
    On pages 86176 and 86282, we are correcting references to the 
weight scalar used in ASC payment rate calculations from ``0.8591'' to 
``0.8547'' to include the effect of our policy to unpackage HCPCS code 
J1097 (phenylephrine 10.16 mg/ml and ketorolac 2.88 mg/ml ophthalmic 
irrigation solution, 1 ml) for CY 2021 (85 FR 86172). We also 
inadvertently omitted prospective expenditures related to HCPCS code 
J1097 for CY 2021 in our calculation of the ASC budget neutrality 
adjustment. We note that the ASC weight scalar of 0.8547 includes this 
correction, the correction noted above for CPT code 0404T, and accounts 
for the increase in CY 2021 Medicare Physician Fee Schedule payment 
amounts of 3.75 percent, which is required by section 101(a) of 
Division N, Title I of the Consolidated Appropriations Act (CAA), 2021 
(Pub. L. 116-260). For office-based covered surgical procedures and 
certain covered ancillary radiology services and diagnostic tests under 
the ASC payment system, the payment rate is the lower of the final CY 
2021 MPFS nonfacility PE RVU-based amount multiplied by the MPFS 
conversion factor or the OPPS-relative weight-based CY 2021 ASC payment 
amount, and accordingly, it was necessary to update the MPFS-based ASC 
rates for CY 2021.
3. Hospital Outpatient Quality Reporting Program Correction
    On page 86182, in footnote 107, the url in the following reference 
is corrected: ``The data reviewed are maintained in the CMS Integrated 
Data Repository (IDR). The IDR is a high volume data warehouse 
integrating Medicare Parts A, B, C, and D, and DME claims, beneficiary 
and provider data sources, along with ancillary data such as contract 
information and risk scores. Additional information is available at 
https://www.cms.gov/Research-Statistics-DataandSystems/Computer-Data-and-Systems/IDR/.'' The url is corrected to read: https://www.cms.gov/Research-Statistics-Data-and-Systems/Computer-Data-and-Systems/IDR.
4. Ambulatory Surgical Center Quality Reporting Program Correction
    On page 86192, in footnote 110, the url in the following reference 
is not correct: ``For more information on the ECE policy, we refer 
stakeholders to the QualityNet website at https://www.qualitynet.org/asc/datasubmission#tab2.'' The url is corrected to read: https://www.qualitynet.org/asc/ascqr/participation#tab2.

B. Summary of Errors and Corrections to the OPPS and ASC Addenda Posted 
on the CMS Website

1. OPPS Addenda Posted on the CMS Website
    In Addendum A of the CY 2021 OPPS/ASC final rule with comment 
period, APC 9370 had an incorrect payment rate of $0.752. We corrected 
the following:
     For APC 9370 (Fluoroestradiol f 18), we included an 
incorrect payment rate. Specifically, we are correcting the payment 
rate from $0.752 to $626.583.
    In Addendum B of the CY 2021 OPPS/ASC final rule with comment 
period, HCPCS codes G2061, G2062, and G2063 are incorrectly shown as 
active codes with status indicator ``A'' to indicate that they should 
be paid under a fee schedule or payment system other than the OPPS. 
These codes have been deleted effective December 31, 2020, and 
therefore should be assigned status indicator ``D'' to indicate that 
they are discontinued codes. These codes have been replaced with CPT 
codes 98970, 98971, and 98972, respectively. CPT codes 98970, 98971, 
and 98972 were incorrectly assigned to status indicator ``B'' to 
indicate that another more appropriate code should be reported. But 
because these codes are replacing HCPCS codes G2061, G2062, and G2063, 
they should be assigned status indicator ``A''. Therefore, in the 
Addendum B (Final OPPS Payment by HCPCS code for CY 2021), we corrected 
the following:
     HCPCS code G2061 (Qual nonmd est pt 5-10m): We made a 
typographical error in the status indicator assignment. Specifically, 
we are correcting the status indicator from ``A'' to ``D''.
     HCPCS code G2062 (Qual nonmd est pt 11-20m): We made a 
typographical error in the status indicator assignment. Specifically, 
we are correcting the status indicator from ``A'' to ``D''.
     HCPCS code G2063 (Qual nonmd est pt 21>min): We made a 
typographical error in the status indicator assignment. Specifically, 
we are correcting the status indicator from ``A'' to ``D''.
     CPT code 98970 (Qnhp ol dig assmt&mgmt 5-10): We made a 
typographical error in the status indicator assignment. Specifically, 
we are correcting the status indicator from ``B'' to ``A''. We are also 
assigning 98970 to comment indicator ``CH'' to indicate that its status 
indicator has changed.
     CPT code 98971 (Qnhp ol dig assmt&mgmt 11-20): We made a 
typographical error in the status indicator assignment. Specifically, 
we are correcting the status indicator from ``B'' to ``A''. We are also 
assigning 98971 to comment indicator ``CH'' to indicate that its status 
indicator has changed.
     CPT code 98972 (Qnhp ol dig assmt&mgmt 21+): We made a 
typographical error in the status indicator assignment. Specifically, 
we

[[Page 11430]]

are correcting the status indicator from ``B'' to ``A''. We are also 
assigning 98972 to comment indicator ``CH'' to indicate that its status 
indicator has changed.
    In Addendum B of the CY 2021 OPPS/ASC final rule with comment 
period, HCPCS codes G2010 and G2012 were incorrectly assigned to status 
indicator ``A'' to indicate that they should be paid under a fee 
schedule or payment system other than the OPPS. However, because these 
codes were replaced with HCPCS codes G2250 and G2251 for certain non-
physician practitioners, including rehabilitation therapists, effective 
January 1, 2021, we assigned them to status indicator ``B'' under the 
OPPS to indicate that other more appropriate codes should be reported. 
Therefore, in the Addendum B (Final OPPS Payment by HCPCS code for CY 
2021), we corrected the following:
     HCPCS code G2010 (Remote evaluation of recorded video and/
or images submitted by an established patient (e.g., store and 
forward), including interpretation with follow-up with the patient 
within 24 business hours, not originating from a related e/m service 
provided within the previous 7 days nor leading to an e/m service or 
procedure within the next 24 hours or soonest available appointment). 
We made a typographical error in the status indicator assignment. 
Specifically, we are correcting the status indicator from ``A'' to 
``B''.
     HCPCS code G2012 (Brief communication technology-based 
service, e.g., virtual check-in, by a physician or other qualified 
health care professional who can report evaluation and management 
services, provided to an established patient, not originating from a 
related e/m service provided within the previous 7 days nor leading to 
an e/m service or procedure within the next 24 hours or soonest 
available appointment; 5-10 minutes of medical discussion). We made a 
typographical error in the status indicator assignment. Specifically, 
we are correcting the status indicator from ``A'' to ``B''.
    In Addendum B of the CY 2021 OPPS/ASC final rule with comment 
period, HCPCS code G2211 was incorrectly assigned to status indicator 
``N'' to indicate that it should be packaged under the OPPS. We 
intended to assign this code to status indicator ``B'' to indicate that 
it should not be payable under the OPPS because this code is an add-on 
code to existing Evaluation and Management code(s) that are assigned to 
status indicator ``B''. Therefore, in the Addendum B (Final OPPS 
Payment by HCPCS code for CY 2021), we corrected the following:
     HCPCS code G2211 (Visit complexity inherent to evaluation 
and management associated with medical care services that serve as the 
continuing focal point for all needed health care services and/or with 
medical care services that are part of ongoing care related to a 
patient's single, serious condition or a complex condition. (add-on 
code, list separately in addition to office/outpatient evaluation and 
management visit, new or established)). We made a typographical error 
in the status indicator assignment. Specifically, we are correcting the 
status indicator from ``N'' to ``B''.
    In Addendum B of the CY 2021 OPPS/ASC final rule with comment 
period, HCPCS code A9591 had an incorrect payment rate of $0.752. We 
corrected the following:
     For HCPCS A9591 (Fluoroestradiol f 18, diagnostic, 1 
millicurie), we included an incorrect payment rate. Specifically, we 
are correcting the payment rate from $0.752 to $626.583.
    In Addendum C of the CY 2021 OPPS/ASC final rule with comment 
period, APC 9370, HCPCS code A9591 had an incorrect payment rate of 
$0.752. We corrected the following:
     For APC 9370 (Fluoroestradiol f 18), HCPCS code A9591 
(Fluoroestradiol f 18, diagnostic, 1 millicurie), we included an 
incorrect payment rate. Specifically, we are correcting the payment 
rate from $0.752 to $626.583.
    In Addendum P, in the tab titled ``2021 FR Device Intensive List'', 
we inadvertently omitted CPT code 0404T from this list. CPT code 0404T 
was finalized as a device-intensive procedure for CY 2021 with a device 
offset percentage of 31 percent. We have added this procedure to the 
list of device-intensive procedures on this tab in Addendum P.
    To view the corrected CY 2021 OPPS status indicators, comment 
indicators, APC assignments, relative weights, payment rates, copayment 
rates, device-intensive status, and short descriptors in Addenda A, B, 
C, and P, we refer readers to the Addenda and supporting files that are 
posted on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/. Select ``CMS-
1736-CN'' from the list of regulations. All corrected Addenda for this 
correcting document are contained in the zipped folder titled ``2021 
OPPS Final Rule Addenda'' at the bottom of the page for CMS-1736-CN.
2. ASC Payment System Addenda Posted on the CMS Website
    In Addenda AA and BB, we inadvertently applied an incorrect ASC 
weight scalar to calculate payment rates under the ASC payment system. 
In our CY 2021 OPPS/ASC final rule with comment period, we finalized a 
policy to unpackage HCPCS code J1097 (phenylephrine 10.16 mg/ml and 
ketorolac 2.88 mg/ml ophthalmic irrigation solution, 1 ml) for CY 2021 
(85 FR 86172). However, in our budget neutrality adjustment 
calculation, we inadvertently omitted prospective expenditures related 
to J1097 for CY 2021. This error impacted the calculation of the ASC 
weight scalar and ASC payment rates. Accordingly, we have updated 
Addenda AA and BB to accurately reflect the ASC payment rates based on 
the revised ASC weight scalar, as corrected in this notice and updated 
to include the increased MPFS rates required by section 101(a) of 
Division N, Title I of the Consolidated Appropriations Act, 2021.
    In Addendum BB of the CY 2021 OPPS/ASC final rule with comment 
period, HCPCS code A9591 had an incorrect payment rate of $0.75. We 
corrected the following:
     For HCPCS A9591 (Fluoroestradiol f 18, diagnostic, 1 
millicurie), we included an incorrect payment rate. Specifically, we 
are correcting the payment rate from $0.75 to $626.58.
    To view the corrected final CY 2021 ASC payment indicators, payment 
weights, payment rates, and multiple procedure discounting indicator in 
Addenda AA and BB, we refer readers to the Addenda and supporting files 
on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ASCPayment/ASC-Regulations-and-Notices.html. Select 
``CMS-1736-CN'' from the list of regulations. All corrected ASC addenda 
for this correcting document are contained in the zipped folder titled 
``Addendum AA, BB, DD1, DD2, and EE'' at the bottom of the page for 
CMS-1736-CN.

III. Waiver of Proposed Rulemaking, 60-Day Comment Period, and Delay in 
Effective Date

    Under 5 U.S.C. 553(b) of the Administrative Procedure Act (APA), 
the agency is required to publish a notice of proposed rulemaking in 
the Federal Register before the provisions of a rule take effect. 
Similarly, section 1871(b)(1) of the Act requires the Secretary to 
provide notice of the proposed rulemaking in the Federal Register and a 
period of not less than 60 days for public comment. In addition, 
section 553(d) of the APA and section 1871(e)(1)(B)(i) of the Act 
mandate a 30-day delay in effective date after issuance or publication 
of a rule. Sections

[[Page 11431]]

553(b)(B) and 553(d)(3) of the APA provide for exceptions from the 
notice and comment and delay in effective date APA requirements; in 
cases in which these exceptions apply, sections 1871(b)(2)(C) and 
1871(e)(1)(B)(ii) of the Act provide exceptions from the notice and 60-
day comment period and delay in effective date requirements of the Act 
as well. Section 553(b)(B) of the APA and section 1871(b)(2)(C) of the 
Act authorize an agency to dispense with normal rulemaking requirements 
for good cause if the agency makes a finding that the notice and 
comment process are impracticable, unnecessary, or contrary to the 
public interest. In addition, both sections 553(d)(3) of the APA and 
section 1871(e)(1)(B)(ii) of the Act allow the agency to avoid the 30-
day delay in effective date where such delay is contrary to the public 
interest and an agency includes a statement of support.
    We believe that this correcting document does not constitute a rule 
that would be subject to the notice and comment or delayed effective 
date requirements. This document corrects technical and typographic 
errors in the preamble, addenda, payment rates, tables, and appendices 
included or referenced in the CY 2021 OPPS/ASC final rule with comment 
period, but does not make substantive changes to the policies or 
payment methodologies that were adopted in the final rule with comment 
period. As a result, this correcting document is intended to ensure 
that the information in the CY 2021 OPPS/ASC final rule with comment 
period accurately reflects the policies adopted in that document.
    In addition, even if this were a rule to which the notice and 
comment procedures and delayed effective date requirements applied, we 
find that there is good cause to waive such requirements. Undertaking 
further notice and comment procedures to incorporate the corrections in 
this document into the final rule or delaying the effective date would 
be contrary to the public interest because it is in the public's 
interest for providers to receive appropriate payments in as timely a 
manner as possible, and to ensure that the CY 2021 OPPS/ASC final rule 
accurately reflects our policies as of the date they take effect and 
are applicable.
    Furthermore, such procedures would be unnecessary, as we are not 
altering our payment methodologies or policies, but rather, we are 
simply correctly implementing the policies that we previously proposed, 
received comment on, and subsequently finalized. This correcting 
document is intended solely to ensure that the CY 2021 OPPS/ASC final 
rule with comment period accurately reflects these payment 
methodologies and policies. For these reasons, we believe we have good 
cause to waive the notice and comment and effective date requirements. 
Moreover, even if these corrections were considered to be retroactive 
rulemaking, they would be authorized under section 1871(e)(1)(A)(ii) of 
the Act, which permits the Secretary to issue a rule for the Medicare 
program with retroactive effect if the failure to do so would be 
contrary to the public interest. As we have explained previously, we 
believe it would be contrary to the public interest not to implement 
the corrections in this correcting document because it is in the 
public's interest for providers to receive appropriate payments in as 
timely a manner as possible, and to ensure that the CY 2021 OPPS/ASC 
final rule with comment period accurately reflects our policies.

IV. Correction of Errors

    In FR Doc. 2020-26819 of December 29, 2020 (85 FR 85866), make the 
following corrections:
    1. On page 85987, third column, after the second full paragraph 
ending with ``Addendum B is available via the internet on the CMS 
website.'' and before the section titled ``IV. OPPS Payment for 
Devices,'' the following section and text are added:

31. Other Procedures/Services

    For CY 2021, we proposed to continue to assign CPT code 0607T to 
APC 5012 (Clinic Visits and Related Services) with status indicator 
``V'' (Clinic or Emergency Department Visit. Paid under OPPS; separate 
APC payment) and a proposed payment rate of $120.88. In addition, we 
proposed to continue to assign CPT code 0608T to APC 5741 (Level 1 
Electronic Analysis of Devices) with status indicator ``S'' (Procedure 
or Service, Not Discounted When Multiple. Paid under OPPS; separate APC 
payment) and a proposed payment rate of $37.76. Below are the long 
descriptors for CPT codes 0607T and 0608T:
     0607T: Remote monitoring of an external continuous 
pulmonary fluid monitoring system, including measurement of 
radiofrequency-derived pulmonary fluid levels, heart rate, respiration 
rate, activity, posture, and cardiovascular rhythm (e.g., ECG data), 
transmitted to a remote 24-hour attended surveillance center; set-up 
and patient education on use of equipment; and
     0608T: Remote monitoring of an external continuous 
pulmonary fluid monitoring system, including measurement of 
radiofrequency-derived pulmonary fluid levels, heart rate, respiration 
rate, activity, posture, and cardiovascular rhythm (e.g., ECG data), 
transmitted to a remote 24-hour attended surveillance center; analysis 
of data received and transmission of reports to the physician or other 
qualified health care professional.
    Comment: A commenter requested that we reassign CPT codes 0607T and 
0608T to non-payable OPPS status indicators because the commenter 
contended that the service associated with the codes is not provided to 
hospital outpatients during a hospital outpatient encounter. The 
commenter specifically requested that both codes be reassigned to 
either status indicator ``B'' (Codes that are not recognized by OPPS. 
Not paid under OPPS) or ``M'' (Items and Services Not Billable to the 
MAC. Not paid under OPPS) for both codes. The commenter reported that 
the services are prescribed by individual physicians, and are not 
currently provided to either hospital inpatients or outpatients, or in 
conjunction with any hospital service. According to the commenter, 
there is no hospital in the U.S. that possesses the technology to 
provide a remote pulmonary fluid monitoring system and further stated 
that ambulatory fluid monitoring system is only available through a 
single Independent Diagnostic Testing Facility (IDTF) in Pittsburgh, 
Pennsylvania. The commenter explained that an individual physician will 
prescribe the ambulatory fluid monitoring device for their patient and 
submit the medical order to the IDTF. Thereafter, the IDTF is 
ultimately responsible for the transmission, analysis, and creation of 
reports to the prescribing physician.
    Response: Based on our review of the codes and input from our 
medical advisors, the services described by CPT codes 0607T and 0608T 
may be provided in an HOPD setting. While the commenter has indicated 
that the services described by the codes are currently performed by one 
IDTF, we believe that the services can be performed by HOPDs. 
Consequently, for CY 2021, we believe that we should continue to assign 
these codes to APCs 5012 and 5741 so that HOPDs can be paid separately 
if they provide these services in the HOPD setting. Therefore, we are 
finalizing our proposal, without modification, to assign CPT codes 
0607T and 0608T to APCs 5012 and 5741, respectively. The final CY 2021 
payment rate for the codes can be found in Addendum B to this final 
rule with comment period (which is available via the internet on the 
CMS website).

[[Page 11432]]

    2. On page 86033, first column, first full paragraph, in line 5 and 
6, ``third quarter of CY 2020'' is corrected to read ``second quarter 
of CY 2020''.
    3. On page 86035, third column, first partial paragraph, in line 4, 
the year ``CY 2018'' is corrected to read ``CY 2021''.
    4. On Page 86063, Table 42, in the entry for HCPCS code Q4222, 
under the column for ``Final CY 2021 High/Low Cost Assignment,'' 
``Low'' is corrected to read ``High''.
    5. On page 86154, Table 59, in the entry for CPT code 0404T, under 
the column ``Final CY 2021 ASC Payment Indicator,'' ``G2'' is corrected 
to read ``J8''.
    6. On page 86165, Table 60, in the entry for CPT code 0404T, under 
the column ``Final CY 2021 ASC Payment Indicator,'' ``G2'' is corrected 
to read ``J8''.
    7. On page 86175, third column, after the first partial paragraph, 
add the following text:
    On April 10, 2018, OMB issued OMB Bulletin No. 18-03 which 
superseded the August 15, 2017 OMB Bulletin No. 17-01. On September 14, 
2018, OMB issued OMB Bulletin 18-04 which superseded the April 10, 2018 
OMB Bulletin No. 18-03. A copy of OMB Bulletin No. 18-04 may be 
obtained at https://www.whitehouse.gov/wpcontent/uploads/2018/90/Bulletin-18-04.pdf. We are utilizing the revised delineations as set 
forth in the April 10, 2018 OMB Bulletin No. 18-03 and the September 
14, 2018 OMB Bulletin No. 18-04 to calculate the CY 2021 ASC wage index 
effective beginning January 1, 2021.''
    8. On page 86176, third column, first full paragraph, in line 10, 
the figure ``0.8591'' is corrected to read ``0.8547.''
    9. On page 86182, in footnote 107, the url ``https://www.cms.gov/Research-Statistics-DataandSystems/Computer-Data-and-Systems/IDR/'' is corrected to read ``https://www.cms.gov/Research-Statistics-Data-and-Systems/Computer-Data-and-Systems/IDR''.
    10. On page 86192, in footnote 110, the url ``https://www.qualitynet.org/asc/data-submission#tab2'' is corrected to read: 
``https://www.qualitynet.org/asc/ascqr/participation#tab2''.
    11. On page 86273, second column, third full paragraph, in lines 7 
and 8, the figure ``0.2 percent'' is corrected to read ``2.6 percent''.
    12. On page 86282, second column, in the first paragraph under ``2. 
Estimated Effects of CY 2021 ASC Payment System Changes,'' in line 10, 
the figure ``0.8591'' is corrected to read ``0.8547.''

    Dated: February 19, 2021.
Wilma M. Robinson,
Deputy Executive Secretary to the Department, Department of Health and 
Human Services.
[FR Doc. 2021-03852 Filed 2-22-21; 8:45 am]
BILLING CODE 4120-01-P

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