Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2019; Medicare Shared Savings Program Requirements; Quality Payment Program; and Medicaid Promoting Interoperability Program, 35704-36368 [2018-14985]

Agencies

• Centers for Medicare & Medicaid Services
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 83, Number 145 (Friday, July 27, 2018)]
[Proposed Rules]
[Pages 35704-36368]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-14985]



[[Page 35703]]

Vol. 83

Friday,

No. 145

July 27, 2018

Part II

Book 2 of 2 Books

Pages 35703-36398





Department of Health and Human Services





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Centers for Medicare & Medicaid Services



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



Medicare Program; Revisions to Payment Policies Under the Physician Fee 
Schedule and Other Revisions to Part B for CY 2019; Medicare Shared 
Savings Program Requirements; Quality Payment Program; and Medicaid 
Promoting Interoperability Program; Proposed Rules

Federal Register / Vol. 83 , No. 145 / Friday, July 27, 2018 / 
Proposed Rules

[[Page 35704]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

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

[CMS-1693-P]
RIN 0938-AT31


Medicare Program; Revisions to Payment Policies Under the 
Physician Fee Schedule and Other Revisions to Part B for CY 2019; 
Medicare Shared Savings Program Requirements; Quality Payment Program; 
and Medicaid Promoting Interoperability Program

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

ACTION: Proposed rule.

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SUMMARY: This major proposed rule addresses changes to the Medicare 
physician fee schedule (PFS) and other Medicare Part B payment policies 
to ensure that our payment systems are updated to reflect changes in 
medical practice and the relative value of services, as well as changes 
in the statute.

DATES: Comment date: To be assured consideration, comments must be 
received at one of the addresses provided below, no later than 5 p.m. 
on September 10, 2018.

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

FOR FURTHER INFORMATION CONTACT: 
    Jamie Hermansen, (410) 786-2064, for any physician payment issues 
not identified below.

    Lindsey Baldwin, (410) 786-1694, and Emily Yoder, (410) 786-
1804, for issues related to evaluation and management (E/M) payment, 
communication technology-based services and telehealth services.
    Isadora Gil, (410) 786-4532, for issues related to payment rates 
for nonexcepted items and services furnished by nonexcepted off-
campus provider-based departments of a hospital, and work relative 
value units (RVUs).
    Ann Marshall, (410) 786-3059, for issues related to E/M 
documentation guidelines.
    Geri Mondowney, (410) 786-1172, or Donta Henson, (410) 786-1947, 
for issues related to geographic price cost indices (GPCIs).
    Geri Mondowney, (410) 786-1172, or Tourette Jackson, (410) 786-
4735, for issues related to malpractice RVUs.
    Patrick Sartini, (410) 786-9252, for issues related to 
radiologist assistants.
    Michael Soracoe, (410) 786-6312, for issues related to practice 
expense, work RVUs, impacts, and conversion factor.
    Pamela West, (410) 786-2302, for issues related to therapy 
services.
    Edmund Kasaitis, (410) 786-0477, for issues related to reduction 
of wholesale acquisition cost (WAC)-based payment.
    Sarah Harding, (410) 786-4001, or Craig Dobyski, (410) 786-4584, 
for issues related to aggregate reporting of applicable information 
for clinical laboratory fee schedule.
    Amy Gruber, (410) 786-1542, or Glenn McGuirk, (410) 786-5723, 
for issues related to the ambulance fee schedule.
    Corinne Axelrod, (410) 786-5620, for issues related to care 
management services and communication technology-based services in 
Rural Health Clinics (RHCs) and Federally Qualified Health Centers 
(FQHCs).
    JoAnna Baldwin, (410) 786-7205, or Sarah Fulton, (410) 786-2749, 
for issues related to appropriate use criteria for advanced 
diagnostic imaging services.
    David Koppel, (214) 767-4403, for issues related to Medicaid 
Promoting Interoperability Program.
    Fiona Larbi, (410) 786-7224, for issues related to the Medicare 
Shared Savings Program Quality Measures.
    Matthew Edgar, (410) 786-0698, for issues related to the 
physician self-referral law.
    Molly MacHarris, (410) 786-4461, for inquiries related to Merit-
based Incentive Payment System (MIPS).
    Benjamin Chin, (410) 786-0679, for inquiries related to 
Alternative Payment Models (APMs).

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
II. Provisions of the Proposed Rule for PFS
    A. Background
    B. Determination of Practice Expense (PE) Relative Value Units 
(RVUs)
    C. Determination of Malpractice Relative Value Units (RVUs)
    D. Modernizing Medicare Physician Payment by Recognizing 
Communication Technology-Based Services
    E. Potentially Misvalued Services Under the PFS
    F. Radiologist Assistants
    G. Payment Rates Under the Medicare PFS for Nonexcepted Items 
and Services Furnished by Nonexcepted Off-Campus Provider-Based 
Departments of a Hospital
    H. Valuation of Specific Codes
    I. Evaluation & Management (E/M) Visits
    J. Teaching Physician Documentation Requirements for Evaluation 
and Management Services
    K. Solicitation of Public Comments on the Low Expenditure 
Threshold Component of the Applicable Laboratory Definition Under 
the Medicare Clinical Laboratory Fee Schedule (CLFS)
    L. GPCI Comment Solicitation
    M. Therapy Services
    N. Part B Drugs: Application of an Add-On Percentage for Certain 
Wholesale Acquisition Cost (WAC)-Based Payments
III. Other Provisions of the Proposed Rule
    A. Clinical Laboratory Fee Schedule
    B. Proposed Changes to the Regulations Associated With the 
Ambulance Fee Schedule
    C. Payment for Care Management Services and Communication 
Technology-Based Services in Rural Health Clinics (RHCs) and 
Federally Qualified Health Centers (FQHCs)
    D. Appropriate Use Criteria for Advanced Diagnostic Imaging 
Services
    E. Medicaid Promoting Interoperability Program Requirements for 
Eligible Professionals (EPs)
    F. Medicare Shared Savings Program Quality Measures
    G. Physician Self-Referral Law
    H. CY 2019 Updates to the Quality Payment Program
IV. Requests for Information
    A. Request for Information on Promoting Interoperability and 
Electronic Healthcare Information Exchange Through Possible 
Revisions to the CMS Patient Health and Safety Requirements for 
Hospitals and Other Medicare- and Medicaid-Participating Providers 
and Suppliers
    B. Request for Information on Price Transparency: Improving 
Beneficiary Access to Provider and Supplier Charge Information
V. Collection of Information Requirements
VI. Response to Comments
VII. Regulatory Impact Analysis
Regulations Text
Appendix 1: Proposed MIPS Quality Measures
Appendix 2: Improvement Activities

Addenda Available Only Through the Internet on the CMS Website

    The PFS Addenda along with other supporting documents and tables 
referenced in this proposed rule are available on the CMS website at 
https://www.cms.gov/Medicare/Medicare-Fee-

[[Page 35705]]

for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-
Notices.html. Click on the link on the left side of the screen titled, 
``PFS Federal Regulations Notices'' for a chronological list of PFS 
Federal Register and other related documents. For the CY 2019 PFS 
Proposed Rule, refer to item CMS-1693-P. Readers with questions related 
to accessing any of the Addenda or other supporting documents 
referenced in this proposed rule and posted on the CMS website 
identified above should contact Jamie Hermansen at (410) 786-2064.

CPT (Current Procedural Terminology) Copyright Notice

    Throughout this proposed rule, we use CPT codes and descriptions to 
refer to a variety of services. We note that CPT codes and descriptions 
are copyright 2017 American Medical Association. All Rights Reserved. 
CPT is a registered trademark of the American Medical Association 
(AMA). Applicable Federal Acquisition Regulations (FAR) and Defense 
Federal Acquisition Regulations (DFAR) apply.

I. Executive Summary

A. Purpose

    This major proposed rule proposes to revise payment polices under 
the Medicare PFS and make other policy changes, including proposals to 
implement certain provisions of the Bipartisan Budget Act of 2018 (Pub. 
L. 115-123, enacted on February 9, 2018), related to Medicare Part B 
payment, applicable to services furnished in CY 2019. In addition, this 
proposed rule includes proposals related to payment policy changes that 
are addressed in section III. of this proposed rule. We are requesting 
public comments on all of the proposals being made in this proposed 
rule.
1. Summary of the Major Provisions
    The statute requires us to establish payments under the PFS based 
on national uniform relative value units (RVUs) that account for the 
relative resources used in furnishing a service. The statute requires 
that RVUs be established for three categories of resources: Work; 
practice expense (PE); and malpractice (MP) expense. In addition, the 
statute requires that we establish by regulation each year's payment 
amounts for all physicians' services paid under the PFS, incorporating 
geographic adjustments to reflect the variations in the costs of 
furnishing services in different geographic areas. In this major 
proposed rule, we are proposing to establish RVUs for CY 2019 for the 
PFS, and other Medicare Part B payment policies, to ensure that our 
payment systems are updated to reflect changes in medical practice and 
the relative value of services, as well as changes in the statute. This 
proposed rule includes discussions and proposals regarding:
     Potentially Misvalued Codes.
     Communication Technology-Based Services.
     Valuation of New, Revised, and Misvalued Codes.
     Payment Rates under the PFS for Nonexcepted Items and 
Services Furnished by Nonexcepted Off-Campus Provider-Based Departments 
of a Hospital.
     E/M Visits.
     Therapy Services.
     Clinical Laboratory Fee Schedule.
     Ambulance Fee Schedule--Provisions in the Bipartisan 
Budget Act of 2018.
     Appropriate Use Criteria for Advanced Diagnostic Imaging 
Services.
     Medicaid Promoting Interoperability Program Requirements 
for Eligible Professionals (EPs).
     Medicare Shared Savings Program Quality Measures.
     Physician Self-Referral Law.
     CY 2019 Updates to the Quality Payment Program.
     Request for Information on Promoting Interoperability and 
Electronic Healthcare Information Exchange through Possible Revisions 
to the CMS Patient Health and Safety Requirements for Hospitals and 
Other Medicare- and Medicaid-Participating Providers and Suppliers.
     Request for Information on Price Transparency: Improving 
Beneficiary Access to Provider and Supplier Charge Information.
2. Summary of Costs and Benefits
    We have determined that this major proposed rule is economically 
significant. For a detailed discussion of the economic impacts, see 
section VII. of this proposed rule.

II. Provisions of the Proposed Rule for the PFS

A. Background

    Since January 1, 1992, Medicare has paid for physicians' services 
under section 1848 of the Act, ``Payment for Physicians' Services.'' 
The PFS relies on national relative values that are established for 
work, practice expense (PE), and malpractice (MP), which are adjusted 
for geographic cost variations. These values are multiplied by a 
conversion factor (CF) to convert the relative value units (RVUs) into 
payment rates. The concepts and methodology underlying the PFS were 
enacted as part of the Omnibus Budget Reconciliation Act of 1989 (Pub. 
L. 101-239, enacted on December 19, 1989) (OBRA '89), and the Omnibus 
Budget Reconciliation Act of 1990 (Pub. L. 101-508, enacted on November 
5, 1990) (OBRA '90). The final rule published on November 25, 1991 (56 
FR 59502) set forth the first fee schedule used for payment for 
physicians' services.
    We note that throughout this major proposed rule, unless otherwise 
noted, the term ``practitioner'' is used to describe both physicians 
and nonphysician practitioners (NPPs) who are permitted to bill 
Medicare under the PFS for the services they furnish to Medicare 
beneficiaries.
1. Development of the Relative Values
a. Work RVUs
    The work RVUs established for the initial fee schedule, which was 
implemented on January 1, 1992, were developed with extensive input 
from the physician community. A research team at the Harvard School of 
Public Health developed the original work RVUs for most codes under a 
cooperative agreement with the Department of Health and Human Services 
(HHS). In constructing the code-specific vignettes used in determining 
the original physician work RVUs, Harvard worked with panels of 
experts, both inside and outside the federal government, and obtained 
input from numerous physician specialty groups.
    As specified in section 1848(c)(1)(A) of the Act, the work 
component of physicians' services means the portion of the resources 
used in furnishing the service that reflects physician time and 
intensity. We establish work RVUs for new, revised and potentially 
misvalued codes based on our review of information that generally 
includes, but is not limited to, recommendations received from the 
American Medical Association/Specialty Society Relative Value Scale 
Update Committee (RUC), the Health Care Professionals Advisory 
Committee (HCPAC), the Medicare Payment Advisory Commission (MedPAC), 
and other public commenters; medical literature and comparative 
databases; as well as a comparison of the work for other codes within 
the Medicare PFS, and consultation with other physicians and health 
care professionals within CMS and the federal government. We also 
assess the methodology and data used to develop the recommendations 
submitted to us by the RUC and other

[[Page 35706]]

public commenters, and the rationale for their recommendations. In the 
CY 2011 PFS final rule with comment period (75 FR 73328 through 73329), 
we discussed a variety of methodologies and approaches used to develop 
work RVUs, including survey data, building blocks, crosswalk to key 
reference or similar codes, and magnitude estimation. More information 
on these issues is available in that rule.
b. Practice Expense RVUs
    Initially, only the work RVUs were resource-based, and the PE and 
MP RVUs were based on average allowable charges. Section 121 of the 
Social Security Act Amendments of 1994 (Pub. L. 103-432, enacted on 
October 31, 1994), amended section 1848(c)(2)(C)(ii) of the Act and 
required us to develop resource-based PE RVUs for each physicians' 
service beginning in 1998. We were required to consider general 
categories of expenses (such as office rent and wages of personnel, but 
excluding MP expenses) comprising PEs. The PE RVUs continue to 
represent the portion of these resources involved in furnishing PFS 
services.
    Originally, the resource-based method was to be used beginning in 
1998, but section 4505(a) of the Balanced Budget Act of 1997 (Pub. L. 
105-33, enacted on August 5, 1997) (BBA) delayed implementation of the 
resource-based PE RVU system until January 1, 1999. In addition, 
section 4505(b) of the BBA provided for a 4-year transition period from 
the charge-based PE RVUs to the resource-based PE RVUs.
    We established the resource-based PE RVUs for each physicians' 
service in the November 2, 1998 final rule (63 FR 58814), effective for 
services furnished in CY 1999. Based on the requirement to transition 
to a resource-based system for PE over a 4-year period, payment rates 
were not fully based upon resource-based PE RVUs until CY 2002. This 
resource-based system was based on two significant sources of actual PE 
data: The Clinical Practice Expert Panel (CPEP) data; and the AMA's 
Socioeconomic Monitoring System (SMS) data. These data sources are 
described in greater detail in the CY 2012 PFS final rule with comment 
period (76 FR 73033).
    Separate PE RVUs are established for services furnished in facility 
settings, such as a hospital outpatient department (HOPD) or an 
ambulatory surgical center (ASC), and in nonfacility settings, such as 
a physician's office. The nonfacility RVUs reflect all of the direct 
and indirect PEs involved in furnishing a service described by a 
particular HCPCS code. The difference, if any, in these PE RVUs 
generally results in a higher payment in the nonfacility setting 
because in the facility settings some costs are borne by the facility. 
Medicare's payment to the facility (such as the outpatient prospective 
payment system (OPPS) payment to the HOPD) would reflect costs 
typically incurred by the facility. Thus, payment associated with those 
facility resources is not made under the PFS.
    Section 212 of the Balanced Budget Refinement Act of 1999 (Pub. L. 
106-113, enacted on November 29, 1999) (BBRA) directed the Secretary of 
Health and Human Services (the Secretary) to establish a process under 
which we accept and use, to the maximum extent practicable and 
consistent with sound data practices, data collected or developed by 
entities and organizations to supplement the data we normally collect 
in determining the PE component. On May 3, 2000, we published the 
interim final rule (65 FR 25664) that set forth the criteria for the 
submission of these supplemental PE survey data. The criteria were 
modified in response to comments received, and published in the Federal 
Register (65 FR 65376) as part of a November 1, 2000 final rule. The 
PFS final rules published in 2001 and 2003, respectively, (66 FR 55246 
and 68 FR 63196) extended the period during which we would accept these 
supplemental data through March 1, 2005.
    In the CY 2007 PFS final rule with comment period (71 FR 69624), we 
revised the methodology for calculating direct PE RVUs from the top-
down to the bottom-up methodology beginning in CY 2007. We adopted a 4-
year transition to the new PE RVUs. This transition was completed for 
CY 2010. In the CY 2010 PFS final rule with comment period, we updated 
the practice expense per hour (PE/HR) data that are used in the 
calculation of PE RVUs for most specialties (74 FR 61749). In CY 2010, 
we began a 4-year transition to the new PE RVUs using the updated PE/HR 
data, which was completed for CY 2013.
c. Malpractice RVUs
    Section 4505(f) of the BBA amended section 1848(c) of the Act to 
require that we implement resource-based MP RVUs for services furnished 
on or after CY 2000. The resource-based MP RVUs were implemented in the 
PFS final rule with comment period published November 2, 1999 (64 FR 
59380). The MP RVUs are based on commercial and physician-owned 
insurers' MP insurance premium data from all the states, the District 
of Columbia, and Puerto Rico. For more information on MP RVUs, see 
section II.C. of this proposed rule.
d. Refinements to the RVUs
    Section 1848(c)(2)(B)(i) of the Act requires that we review RVUs no 
less often than every 5 years. Prior to CY 2013, we conducted periodic 
reviews of work RVUs and PE RVUs independently. We completed 5-year 
reviews of work RVUs that were effective for calendar years 1997, 2002, 
2007, and 2012.
    Although refinements to the direct PE inputs initially relied 
heavily on input from the RUC Practice Expense Advisory Committee 
(PEAC), the shifts to the bottom-up PE methodology in CY 2007 and to 
the use of the updated PE/HR data in CY 2010 have resulted in 
significant refinements to the PE RVUs in recent years.
    In the CY 2012 PFS final rule with comment period (76 FR 73057), we 
finalized a proposal to consolidate reviews of work and PE RVUs under 
section 1848(c)(2)(B) of the Act and reviews of potentially misvalued 
codes under section 1848(c)(2)(K) of the Act into one annual process.
    In addition to the 5-year reviews, beginning for CY 2009, CMS and 
the RUC identified and reviewed a number of potentially misvalued codes 
on an annual basis based on various identification screens. This annual 
review of work and PE RVUs for potentially misvalued codes was 
supplemented by the amendments to section 1848 of the Act, as enacted 
by section 3134 of the Affordable Care Act, that require the agency to 
periodically identify, review and adjust values for potentially 
misvalued codes.
e. Application of Budget Neutrality to Adjustments of RVUs
    As described in section VII. of this proposed rule, in accordance 
with section 1848(c)(2)(B)(ii)(II) of the Act, if revisions to the RVUs 
cause expenditures for the year to change by more than $20 million, we 
make adjustments to ensure that expenditures do not increase or 
decrease by more than $20 million.
2. Calculation of Payments Based on RVUs
    To calculate the payment for each service, the components of the 
fee schedule (work, PE, and MP RVUs) are adjusted by geographic 
practice cost indices (GPCIs) to reflect the variations in the costs of 
furnishing the services. The GPCIs reflect the relative costs of work, 
PE, and MP in an area compared to the national average costs for each

[[Page 35707]]

component. Please refer to the CY 2017 PFS final rule with comment 
period for a discussion of the last GPCI update (81 FR 80261 through 
80270).
    RVUs are converted to dollar amounts through the application of a 
CF, which is calculated based on a statutory formula by CMS's Office of 
the Actuary (OACT). The formula for calculating the Medicare PFS 
payment amount for a given service and fee schedule area can be 
expressed as:

Payment = [(RVU work x GPCI work) + (RVU PE x GPCI PE) + (RVU MP x GPCI 
MP)] x CF
3. Separate Fee Schedule Methodology for Anesthesia Services
    Section 1848(b)(2)(B) of the Act specifies that the fee schedule 
amounts for anesthesia services are to be based on a uniform relative 
value guide, with appropriate adjustment of an anesthesia CF, in a 
manner to ensure that fee schedule amounts for anesthesia services are 
consistent with those for other services of comparable value. 
Therefore, there is a separate fee schedule methodology for anesthesia 
services. Specifically, we establish a separate CF for anesthesia 
services and we utilize the uniform relative value guide, or base 
units, as well as time units, to calculate the fee schedule amounts for 
anesthesia services. Since anesthesia services are not valued using 
RVUs, a separate methodology for locality adjustments is also 
necessary. This involves an adjustment to the national anesthesia CF 
for each payment locality.

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

1. Overview
    Practice expense (PE) is the portion of the resources used in 
furnishing a service that reflects the general categories of physician 
and practitioner expenses, such as office rent and personnel wages, but 
excluding MP expenses, as specified in section 1848(c)(1)(B) of the 
Act. As required by section 1848(c)(2)(C)(ii) of the Act, we use a 
resource-based system for determining PE RVUs for each physicians' 
service. We develop PE RVUs by considering the direct and indirect 
practice resources involved in furnishing each service. Direct expense 
categories include clinical labor, medical supplies, and medical 
equipment. Indirect expenses include administrative labor, office 
expense, and all other expenses. The sections that follow provide more 
detailed information about the methodology for translating the 
resources involved in furnishing each service into service-specific PE 
RVUs. We refer readers to the CY 2010 PFS final rule with comment 
period (74 FR 61743 through 61748) for a more detailed explanation of 
the PE methodology.
2. Practice Expense Methodology
a. Direct Practice Expense
    We determine the direct PE for a specific service by adding the 
costs of the direct resources (that is, the clinical staff, medical 
supplies, and medical equipment) typically involved with furnishing 
that service. The costs of the resources are calculated using the 
refined direct PE inputs assigned to each CPT code in our PE database, 
which are generally based on our review of recommendations received 
from the RUC and those provided in response to public comment periods. 
For a detailed explanation of the direct PE methodology, including 
examples, we refer readers to the Five-Year Review of Work Relative 
Value Units under the PFS and Proposed Changes to the Practice Expense 
Methodology CY 2007 PFS proposed notice (71 FR 37242) and the CY 2007 
PFS final rule with comment period (71 FR 69629).
b. Indirect Practice Expense per Hour Data
    We use survey data on indirect PEs incurred per hour worked in 
developing the indirect portion of the PE RVUs. Prior to CY 2010, we 
primarily used the PE/HR by specialty that was obtained from the AMA's 
SMS. The AMA administered a new survey in CY 2007 and CY 2008, the 
Physician Practice Expense Information Survey (PPIS). The PPIS is a 
multispecialty, nationally representative, PE survey of both physicians 
and NPPs paid under the PFS using a survey instrument and methods 
highly consistent with those used for the SMS and the supplemental 
surveys. The PPIS gathered information from 3,656 respondents across 51 
physician specialty and health care professional groups. We believe the 
PPIS is the most comprehensive source of PE survey information 
available. We used the PPIS data to update the PE/HR data for the CY 
2010 PFS for almost all of the Medicare-recognized specialties that 
participated in the survey.
    When we began using the PPIS data in CY 2010, we did not change the 
PE RVU methodology itself or the manner in which the PE/HR data are 
used in that methodology. We only updated the PE/HR data based on the 
new survey. Furthermore, as we explained in the CY 2010 PFS final rule 
with comment period (74 FR 61751), because of the magnitude of payment 
reductions for some specialties resulting from the use of the PPIS 
data, we transitioned its use over a 4-year period from the previous PE 
RVUs to the PE RVUs developed using the new PPIS data. As provided in 
the CY 2010 PFS final rule with comment period (74 FR 61751), the 
transition to the PPIS data was complete for CY 2013. Therefore, PE 
RVUs from CY 2013 forward are developed based entirely on the PPIS 
data, except as noted in this section.
    Section 1848(c)(2)(H)(i) of the Act requires us to use the medical 
oncology supplemental survey data submitted in 2003 for oncology drug 
administration services. Therefore, the PE/HR for medical oncology, 
hematology, and hematology/oncology reflects the continued use of these 
supplemental survey data.
    Supplemental survey data on independent labs from the College of 
American Pathologists were implemented for payments beginning in CY 
2005. Supplemental survey data from the National Coalition of Quality 
Diagnostic Imaging Services (NCQDIS), representing independent 
diagnostic testing facilities (IDTFs), were blended with supplementary 
survey data from the American College of Radiology (ACR) and 
implemented for payments beginning in CY 2007. Neither IDTFs, nor 
independent labs, participated in the PPIS. Therefore, we continue to 
use the PE/HR that was developed from their supplemental survey data.
    Consistent with our past practice, the previous indirect PE/HR 
values from the supplemental surveys for these specialties were updated 
to CY 2006 using the Medicare Economic Index (MEI) to put them on a 
comparable basis with the PPIS data.
    We also do not use the PPIS data for reproductive endocrinology and 
spine surgery since these specialties currently are not separately 
recognized by Medicare, nor do we have a method to blend the PPIS data 
with Medicare-recognized specialty data.
    Previously, we established PE/HR values for various specialties 
without SMS or supplemental survey data by crosswalking them to other 
similar specialties to estimate a proxy PE/HR. For specialties that 
were part of the PPIS for which we previously used a crosswalked PE/HR, 
we instead used the PPIS-based PE/HR. We use crosswalks for specialties 
that did not participate in the PPIS. These crosswalks have been 
generally established through notice and comment rulemaking and are 
available in the file called ``CY 2019 PFS Proposed Rule PE/HR'' on the 
CMS website under downloads for the CY

[[Page 35708]]

2019 PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    For CY 2019, we have incorporated the available utilization data 
for two new specialties, each of which became a recognized Medicare 
specialty during 2017. These specialties are Hospitalists and Advanced 
Heart Failure and Transplant Cardiology. We are proposing to use proxy 
PE/HR values for these new specialties, as there are no PPIS data for 
these specialties, by crosswalking the PE/HR as follows from 
specialties that furnish similar services in the Medicare claims data:
     Hospitalists from Emergency Medicine.
     Advanced Heart Failure and Transplant Cardiology from 
Cardiology.
    The proposal is reflected in the ``CY 2019 PFS Proposed Rule PE/
HR'' file available on the CMS website under the supporting data files 
for the CY 2019 PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
c. Allocation of PE to Services
    To establish PE RVUs for specific services, it is necessary to 
establish the direct and indirect PE associated with each service.
(1) Direct Costs
    The relative relationship between the direct cost portions of the 
PE RVUs for any two services is determined by the relative relationship 
between the sum of the direct cost resources (that is, the clinical 
staff, medical supplies, and medical equipment) typically involved with 
furnishing each of the services. The costs of these resources are 
calculated from the refined direct PE inputs in our PE database. For 
example, if one service has a direct cost sum of $400 from our PE 
database and another service has a direct cost sum of $200, the direct 
portion of the PE RVUs of the first service would be twice as much as 
the direct portion of the PE RVUs for the second service.
(2) Indirect Costs
    We allocate the indirect costs to the code level on the basis of 
the direct costs specifically associated with a code and the greater of 
either the clinical labor costs or the work RVUs. We also incorporate 
the survey data described earlier in the PE/HR discussion (see section 
II.B.2.b of this proposed rule). The general approach to developing the 
indirect portion of the PE RVUs is as follows:
     For a given service, we use the direct portion of the PE 
RVUs calculated as previously described and the average percentage that 
direct costs represent of total costs (based on survey data) across the 
specialties that furnish the service to determine an initial indirect 
allocator. That is, the initial indirect allocator is calculated so 
that the direct costs equal the average percentage of direct costs of 
those specialties furnishing the service. For example, if the direct 
portion of the PE RVUs for a given service is 2.00 and direct costs, on 
average, represent 25 percent of total costs for the specialties that 
furnish the service, the initial indirect allocator would be calculated 
so that it equals 75 percent of the total PE RVUs. Thus, in this 
example, the initial indirect allocator would equal 6.00, resulting in 
a total PE RVU of 8.00 (2.00 is 25 percent of 8.00 and 6.00 is 75 
percent of 8.00).
     Next, we add the greater of the work RVUs or clinical 
labor portion of the direct portion of the PE RVUs to this initial 
indirect allocator. In our example, if this service had a work RVU of 
4.00 and the clinical labor portion of the direct PE RVU was 1.50, we 
would add 4.00 (since the 4.00 work RVUs are greater than the 1.50 
clinical labor portion) to the initial indirect allocator of 6.00 to 
get an indirect allocator of 10.00. In the absence of any further use 
of the survey data, the relative relationship between the indirect cost 
portions of the PE RVUs for any two services would be determined by the 
relative relationship between these indirect cost allocators. For 
example, if one service had an indirect cost allocator of 10.00 and 
another service had an indirect cost allocator of 5.00, the indirect 
portion of the PE RVUs of the first service would be twice as great as 
the indirect portion of the PE RVUs for the second service.
     Next, we incorporated the specialty-specific indirect PE/
HR data into the calculation. In our example, if, based on the survey 
data, the average indirect cost of the specialties furnishing the first 
service with an allocator of 10.00 was half of the average indirect 
cost of the specialties furnishing the second service with an indirect 
allocator of 5.00, the indirect portion of the PE RVUs of the first 
service would be equal to that of the second service.
(3) Facility and Nonfacility Costs
    For procedures that can be furnished in a physician's office, as 
well as in a facility setting, where Medicare makes a separate payment 
to the facility for its costs in furnishing a service, we establish two 
PE RVUs: facility and nonfacility. The methodology for calculating PE 
RVUs is the same for both the facility and nonfacility RVUs, but is 
applied independently to yield two separate PE RVUs. In calculating the 
PE RVUs for services furnished in a facility, we do not include 
resources that would generally not be provided by physicians when 
furnishing the service. For this reason, the facility PE RVUs are 
generally lower than the nonfacility PE RVUs.
(4) Services With Technical Components and Professional Components
    Diagnostic services are generally comprised of two components: A 
professional component (PC); and a technical component (TC). The PC and 
TC may be furnished independently or by different providers, or they 
may be furnished together as a global service. When services have 
separately billable PC and TC components, the payment for the global 
service equals the sum of the payment for the TC and PC. To achieve 
this, we use a weighted average of the ratio of indirect to direct 
costs across all the specialties that furnish the global service, TCs, 
and PCs; that is, we apply the same weighted average indirect 
percentage factor to allocate indirect expenses to the global service, 
PCs, and TCs for a service. (The direct PE RVUs for the TC and PC sum 
to the global.)
(5) PE RVU Methodology
    For a more detailed description of the PE RVU methodology, we refer 
readers to the CY 2010 PFS final rule with comment period (74 FR 61745 
through 61746). We also direct readers to the file called ``Calculation 
of PE RVUs under Methodology for Selected Codes'' which is available on 
our website under downloads for the CY 2019 PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. This file 
contains a table that illustrates the calculation of PE RVUs as 
described in this proposed rule for individual codes.
(a) Setup File
    First, we create a setup file for the PE methodology. The setup 
file contains the direct cost inputs, the utilization for each 
procedure code at the specialty and facility/nonfacility place of 
service level, and the specialty-specific PE/HR data calculated from 
the surveys.
(b) Calculate the Direct Cost PE RVUs
    Sum the costs of each direct input.
    Step 1: Sum the direct costs of the inputs for each service.

[[Page 35709]]

    Step 2: Calculate the aggregate pool of direct PE costs for the 
current year. We set the aggregate pool of PE costs equal to the 
product of the ratio of the current aggregate PE RVUs to current 
aggregate work RVUs and the proposed aggregate work RVUs.
    Step 3: Calculate the aggregate pool of direct PE costs for use in 
ratesetting. This is the product of the aggregate direct costs for all 
services from Step 1 and the utilization data for that service.
    Step 4: Using the results of Step 2 and Step 3, use the CF to 
calculate a direct PE scaling adjustment to ensure that the aggregate 
pool of direct PE costs calculated in Step 3 does not vary from the 
aggregate pool of direct PE costs for the current year. Apply the 
scaling adjustment to the direct costs for each service (as calculated 
in Step 1).
    Step 5: Convert the results of Step 4 to a RVU scale for each 
service. To do this, divide the results of Step 4 by the CF. Note that 
the actual value of the CF used in this calculation does not influence 
the final direct cost PE RVUs as long as the same CF is used in Step 4 
and Step 5. Different CFs would result in different direct PE scaling 
adjustments, but this has no effect on the final direct cost PE RVUs 
since changes in the CFs and changes in the associated direct scaling 
adjustments offset one another.
(c) Create the Indirect Cost PE RVUs
    Create indirect allocators.
    Step 6: Based on the survey data, calculate direct and indirect PE 
percentages for each physician specialty.
    Step 7: Calculate direct and indirect PE percentages at the service 
level by taking a weighted average of the results of Step 6 for the 
specialties that furnish the service. Note that for services with TCs 
and PCs, the direct and indirect percentages for a given service do not 
vary by the PC, TC, and global service.
    We generally use an average of the 3 most recent years of available 
Medicare claims data to determine the specialty mix assigned to each 
code. Codes with low Medicare service volume require special attention 
since billing or enrollment irregularities for a given year can result 
in significant changes in specialty mix assignment. We finalized a 
proposal in the CY 2018 PFS final rule (82 FR 52982 through 59283) to 
use the most recent year of claims data to determine which codes are 
low volume for the coming year (those that have fewer than 100 allowed 
services in the Medicare claims data). For codes that fall into this 
category, instead of assigning specialty mix based on the specialties 
of the practitioners reporting the services in the claims data, we 
instead use the expected specialty that we identify on a list developed 
based on medical review and input from expert stakeholders. We display 
this list of expected specialty assignments as part of the annual set 
of data files we make available as part of notice and comment 
rulemaking and consider recommendations from the RUC and other 
stakeholders on changes to this list on an annual basis. Services for 
which the specialty is automatically assigned based on previously 
finalized policies under our established methodology (for example, 
``always therapy'' services) are unaffected by the list of expected 
specialty assignments. We also finalized in the CY 2018 PFS final rule 
(82 FR 52982 through 59283) a proposal to apply these service-level 
overrides for both PE and MP, rather than one or the other category.
    For CY 2019, we are proposing to add 28 additional codes that we 
have identified as low volume services to the list of codes for which 
we assign the expected specialty. Based on our own medical review and 
input from the RUC and from specialty societies, we are proposing to 
assign the expected specialty for each code as indicated in Table 1. 
For each of these codes, only the professional component (reported with 
the -26 modifier) is nationally priced. The global and technical 
components are priced by the Medicare Administrative Contractors (MACs) 
which establish RVUs and payment amounts for these services. The list 
of codes that we are proposing to add is displayed in Table 1.

                    Table 1--New Additions to Expected Specialty List for Low Volume Services
----------------------------------------------------------------------------------------------------------------
                                                                                                       2017
           CPT code                Mod           Short descriptor           Expected specialty      Utilization
----------------------------------------------------------------------------------------------------------------
70557........................          26  Mri brain w/o dye...........  Diagnostic Radiology...             126
70558........................          26  Mri brain w/dye.............  Diagnostic Radiology...              32
74235........................          26  Remove esophagus obstruction  Gastroenterology.......              10
74301........................          26  X-rays at surgery add-on....  Diagnostic Radiology...              73
74355........................          26  X-ray guide intestinal tube.  Diagnostic Radiology...              11
74445........................          26  X-ray exam of penis.........  Urology................              26
74742........................          26  X-ray fallopian tube........  Diagnostic Radiology...               5
74775........................          26  X-ray exam of perineum......  Diagnostic Radiology...              80
75801........................          26  Lymph vessel x-ray arm/leg..  Diagnostic Radiology...             114
75803........................          26  Lymph vessel x-ray arms/leg.  Diagnostic Radiology...              41
75805........................          26  Lymph vessel x-ray trunk....  Diagnostic Radiology...              50
75810........................          26  Vein x-ray spleen/liver.....  Diagnostic Radiology...              46
76941........................          26  Echo guide for transfusion..  Obstetrics/Gynecology..              15
76945........................          26  Echo guide villus sampling..  Obstetrics/Gynecology..              31
76975........................          26  Gi endoscopic ultrasound....  Gastroenterology.......              49
78282........................          26  Gi protein loss exam........  Diagnostic Radiology...               8
79300........................          26  Nuclr rx interstit colloid..  Diagnostic Radiology...               2
86327........................          26  Immunoelectrophoresis assay.  Pathology..............              24
87164........................          26  Dark field examination......  Pathology..............              30
88371........................          26  Protein western blot tissue.  Pathology..............               2
93532........................          26  R & l heart cath congenital.  Cardiology.............              28
93533........................          26  R & l heart cath congenital.  Cardiology.............              36
93561........................          26  Cardiac output measurement..  Cardiology.............              28
93562........................          26  Card output measure subsq...  Cardiology.............              38
93616........................          26  Esophageal recording........  Cardiology.............              38
93624........................          26  Electrophysiologic study....  Cardiology.............              51
95966........................          26  Meg evoked single...........  Neurology..............              72
95967........................          26  Meg evoked each addl........  Neurology..............              61
----------------------------------------------------------------------------------------------------------------


[[Page 35710]]

    The complete list of expected specialty assignments for individual 
low volume services, including the proposed assignments for the codes 
identified in Table 1, is available on our website under downloads for 
the CY 2019 PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    Step 8: Calculate the service level allocators for the indirect PEs 
based on the percentages calculated in Step 7. The indirect PEs are 
allocated based on the three components: The direct PE RVUs; the 
clinical labor PE RVUs; and the work RVUs.
    For most services the indirect allocator is: indirect PE percentage 
* (direct PE RVUs/direct percentage) + work RVUs.
    There are two situations where this formula is modified:
     If the service is a global service (that is, a service 
with global, professional, and technical components), then the indirect 
PE allocator is: indirect percentage (direct PE RVUs/direct percentage) 
+ clinical labor PE RVUs + work RVUs.
     If the clinical labor PE RVUs exceed the work RVUs (and 
the service is not a global service), then the indirect allocator is: 
indirect PE percentage (direct PE RVUs/direct percentage) + clinical 
labor PE RVUs.
    (Note: For global services, the indirect PE allocator is based on 
both the work RVUs and the clinical labor PE RVUs. We do this to 
recognize that, for the PC service, indirect PEs would be allocated 
using the work RVUs, and for the TC service, indirect PEs would be 
allocated using the direct PE RVUs and the clinical labor PE RVUs. This 
also allows the global component RVUs to equal the sum of the PC and TC 
RVUs.)
    For presentation purposes, in the examples in the download file 
called ``Calculation of PE RVUs under Methodology for Selected Codes'', 
the formulas were divided into two parts for each service.
     The first part does not vary by service and is the 
indirect percentage (direct PE RVUs/direct percentage).
     The second part is either the work RVU, clinical labor PE 
RVU, or both depending on whether the service is a global service and 
whether the clinical PE RVUs exceed the work RVUs (as described earlier 
in this step).
    Apply a scaling adjustment to the indirect allocators.
    Step 9: Calculate the current aggregate pool of indirect PE RVUs by 
multiplying the result of step 8 by the average indirect PE percentage 
from the survey data.
    Step 10: Calculate an aggregate pool of indirect PE RVUs for all 
PFS services by adding the product of the indirect PE allocators for a 
service from Step 8 and the utilization data for that service.
    Step 11: Using the results of Step 9 and Step 10, calculate an 
indirect PE adjustment so that the aggregate indirect allocation does 
not exceed the available aggregate indirect PE RVUs and apply it to 
indirect allocators calculated in Step 8.
    Calculate the indirect practice cost index.
    Step 12: Using the results of Step 11, calculate aggregate pools of 
specialty-specific adjusted indirect PE allocators for all PFS services 
for a specialty by adding the product of the adjusted indirect PE 
allocator for each service and the utilization data for that service.
    Step 13: Using the specialty-specific indirect PE/HR data, 
calculate specialty-specific aggregate pools of indirect PE for all PFS 
services for that specialty by adding the product of the indirect PE/HR 
for the specialty, the work time for the service, and the specialty's 
utilization for the service across all services furnished by the 
specialty.
    Step 14: Using the results of Step 12 and Step 13, calculate the 
specialty-specific indirect PE scaling factors.
    Step 15: Using the results of Step 14, calculate an indirect 
practice cost index at the specialty level by dividing each specialty-
specific indirect scaling factor by the average indirect scaling factor 
for the entire PFS.
    Step 16: Calculate the indirect practice cost index at the service 
level to ensure the capture of all indirect costs. Calculate a weighted 
average of the practice cost index values for the specialties that 
furnish the service. (Note: For services with TCs and PCs, we calculate 
the indirect practice cost index across the global service, PCs, and 
TCs. Under this method, the indirect practice cost index for a given 
service (for example, echocardiogram) does not vary by the PC, TC, and 
global service.)
    Step 17: Apply the service level indirect practice cost index 
calculated in Step 16 to the service level adjusted indirect allocators 
calculated in Step 11 to get the indirect PE RVUs.
(d) Calculate the Final PE RVUs
    Step 18: Add the direct PE RVUs from Step 5 to the indirect PE RVUs 
from Step 17 and apply the final PE budget neutrality (BN) adjustment. 
The final PE BN adjustment is calculated by comparing the sum of steps 
5 and 17 to the proposed aggregate work RVUs scaled by the ratio of 
current aggregate PE and work RVUs. This adjustment ensures that all PE 
RVUs in the PFS account for the fact that certain specialties are 
excluded from the calculation of PE RVUs but included in maintaining 
overall PFS budget neutrality. (See ``Specialties excluded from 
ratesetting calculation'' later in this final rule.)
    Step 19: Apply the phase-in of significant RVU reductions and its 
associated adjustment. Section 1848(c)(7) of the Act specifies that for 
services that are not new or revised codes, if the total RVUs for a 
service for a year would otherwise be decreased by an estimated 20 
percent or more as compared to the total RVUs for the previous year, 
the applicable adjustments in work, PE, and MP RVUs shall be phased in 
over a 2-year period. In implementing the phase-in, we consider a 19 
percent reduction as the maximum 1-year reduction for any service not 
described by a new or revised code. This approach limits the year one 
reduction for the service to the maximum allowed amount (that is, 19 
percent), and then phases in the remainder of the reduction. To comply 
with section 1848(c)(7) of the Act, we adjust the PE RVUs to ensure 
that the total RVUs for all services that are not new or revised codes 
decrease by no more than 19 percent, and then apply a relativity 
adjustment to ensure that the total pool of aggregate PE RVUs remains 
relative to the pool of work and MP RVUs. For a more detailed 
description of the methodology for the phase-in of significant RVU 
changes, we refer readers to the CY 2016 PFS final rule with comment 
period (80 FR 70927 through 70931).
(e) Setup File Information
     Specialties excluded from ratesetting calculation: For the 
purposes of calculating the PE RVUs, we exclude certain specialties, 
such as certain NPPs paid at a percentage of the PFS and low-volume 
specialties, from the calculation. These specialties are included for 
the purposes of calculating the BN adjustment. They are displayed in 
Table 2.

[[Page 35711]]



       Table 2--Specialties Excluded From Ratesetting Calculation
------------------------------------------------------------------------
        Specialty code                   Specialty description
------------------------------------------------------------------------
49...........................  Ambulatory surgical center.
50...........................  Nurse practitioner.
51...........................  Medical supply company with certified
                                orthotist.
52...........................  Medical supply company with certified
                                prosthetist.
53...........................  Medical supply company with certified
                                prosthetist[dash]orthotist.
54...........................  Medical supply company not included in
                                51, 52, or 53.
55...........................  Individual certified orthotist.
56...........................  Individual certified prosthetist.
57...........................  Individual certified
                                prosthetist[dash]orthotist.
58...........................  Medical supply company with registered
                                pharmacist.
59...........................  Ambulance service supplier, e.g., private
                                ambulance companies, funeral homes, etc.
60...........................  Public health or welfare agencies.
61...........................  Voluntary health or charitable agencies.
73...........................  Mass immunization roster biller.
74...........................  Radiation therapy centers.
87...........................  All other suppliers (e.g., drug and
                                department stores).
88...........................  Unknown supplier/provider specialty.
89...........................  Certified clinical nurse specialist.
96...........................  Optician.
97...........................  Physician assistant.
A0...........................  Hospital.
A1...........................  SNF.
A2...........................  Intermediate care nursing facility.
A3...........................  Nursing facility, other.
A4...........................  HHA.
A5...........................  Pharmacy.
A6...........................  Medical supply company with respiratory
                                therapist.
A7...........................  Department store.
B2...........................  Pedorthic personnel.
B3...........................  Medical supply company with pedorthic
                                personnel.
------------------------------------------------------------------------

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

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

[[Page 35712]]

 
62.................................  Co-surgeons.............  62.5%...................  50%.
66.................................  Team Surgeons...........  33%.....................  33%.
----------------------------------------------------------------------------------------------------------------

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

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

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

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

    Usage: We currently use an equipment utilization rate assumption of 
50 percent for most equipment, with the exception of expensive 
diagnostic imaging equipment, for which we use a 90 percent assumption 
as required by section 1848(b)(4)(C) of the Act.
    Stakeholders have often suggested that particular equipment items 
are used less frequently than 50 percent of the time in the typical 
setting and that CMS should reduce the equipment utilization rate based 
on these recommendations. We appreciate and share stakeholders' 
interest in using the most accurate assumption regarding the equipment 
utilization rate for particular equipment items. However, we believe 
that absent robust, objective, auditable data regarding the use of 
particular items, the 50 percent assumption is the most appropriate 
within the relative value system. We welcome the submission of data 
that illustrates an alternative rate.
    Maintenance: This factor for maintenance was finalized in the CY 
1998 PFS final rule with comment period (62 FR 33164). As we previously 
stated in the CY 2016 final rule with comment period (80 FR 70897), we 
do not believe the annual maintenance factor for all equipment is 
precisely 5 percent, and we concur that the current rate likely 
understates the true cost of maintaining some equipment. We also 
believe it likely overstates the maintenance costs for other equipment. 
When we solicited comments regarding sources of data containing 
equipment maintenance rates, commenters were unable to identify an 
auditable, robust data source that could be used by CMS on a wide 
scale. We do not believe that voluntary submissions regarding the 
maintenance costs of individual equipment items would be an appropriate 
methodology for determining costs. As a result, in the absence of 
publicly available datasets regarding equipment maintenance costs or 
another systematic data collection methodology for determining 
maintenance factor, we do not believe that we have sufficient 
information at present to propose a variable maintenance factor for 
equipment cost per minute pricing. We continue to investigate potential 
avenues for determining equipment maintenance costs across a broad 
range of equipment items.
    Interest Rate: In the CY 2013 PFS final rule with comment period 
(77 FR 68902), we updated the interest rates used in developing an 
equipment cost per minute calculation (see 77 FR 68902 for a thorough 
discussion of this issue). The interest rate was based on the Small 
Business Administration (SBA) maximum interest rates for different 
categories of loan size (equipment cost) and maturity (useful life). We 
are not proposing any changes to these interest rates for CY 2019. The 
interest rates are listed in Table 4.

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

3. Changes to Direct PE Inputs for Specific Services
    This section focuses on specific PE inputs. The direct PE inputs 
are included in the CY 2019 direct PE input database, which is 
available on the CMS website under downloads for the CY 2019 PFS 
proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
a. Standardization of Clinical Labor Tasks
    As we noted in the CY 2015 PFS final rule with comment period (79 
FR 67640-67641), we continue to make improvements to the direct PE 
input database to provide the number of clinical labor minutes assigned 
for each task for every code in the database instead of only including 
the number of clinical labor minutes for the preservice, service, and 
postservice periods for each code. In addition to increasing the 
transparency of the information used to set PE RVUs, this level of 
detail would allow us to compare clinical labor times for activities 
associated with services across the PFS, which we believe is important 
to maintaining the relativity of the direct PE inputs. This information 
would facilitate the identification of the usual numbers of minutes for 
clinical labor tasks and the identification of exceptions to the usual 
values. It would also allow for greater transparency and consistency in 
the assignment of

[[Page 35713]]

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

[[Page 35714]]

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

[[Page 35715]]

we are proposing to update the price of the scope video system (ES031) 
from its current price of $33,391 to a price of $36,306 to reflect the 
addition of the LED light and miscellaneous small equipment associated 
with the system that falls below the threshold of individual equipment 
pricing as scope accessories, as we explained in detail in the CY 2018 
PFS final rule (82 FR 52992 through 52993). We are also proposing to 
update the name of the ES031 equipment item from ``video system, 
endoscopy (processor, digital capture, monitor, printer, cart)'' to 
``scope video system (monitor, processor, digital capture, cart, 
printer, LED light)'' to reflect the fact that the use of the ES031 
scope video system is not limited to endoscopy procedures.
c. Balloon Sinus Surgery Kit (SA106) Comment Solicitation
    Several stakeholders contacted CMS with regard to the use of the 
kit, sinus surgery, balloon (maxillary, frontal, or sphenoid) (SA106) 
supply in CPT codes 31295 (Nasal/sinus endoscopy, surgical; with 
dilation of maxillary sinus ostium (e.g., balloon dilation)), 
transnasal or via canine fossa), 31296 (Nasal/sinus endoscopy, 
surgical; with dilation of frontal sinus ostium (e.g., balloon 
dilation)), and 31297 (Nasal/sinus endoscopy, surgical; with dilation 
of sphenoid sinus ostium (e.g., balloon dilation)). The stakeholders 
stated that the price of the SA106 supply (currently $2,599.86) had 
decreased significantly since it was priced through rulemaking for CY 
2011 (75 FR 73351 through 75532), and that the Medicare payment for 
these three CPT codes using the supply no longer seemed to be in 
proportion to what the kits cost. They also indicated that the same 
catheter could be used to treat multiple sinuses rather than being a 
disposable one-time use supply. The stakeholders stated that marketing 
firms and sales representatives are advertising these CPT codes as a 
method for generating additional profits due to the payment for the 
procedures exceeding the resources typically needed to furnish the 
services, and requested that CMS investigate the use of the SA106 
supply in these codes.
    We appreciate the information supplied by the stakeholders 
regarding the use of the balloon sinus surgery kit. When CPT codes 
31295-31297 were initially reviewed during the CY 2011 and CY 2012 PFS 
rulemaking cycles (75 FR 73251, and 76 FR 73184 through 73186, 
respectively), we expressed our reservations about the pricing and the 
typical quantity of this supply item used in furnishing these services. 
The RUC recommended for the CY 2012 rulemaking cycle that CMS remove 
the balloon sinus surgery kit from each of these codes and implement 
separately billable alpha-numeric HCPCS codes to allow practitioners to 
be paid the cost of the disposable kits per patient encounter instead 
of per CPT code. We stated at the time, and we continue to believe, 
that this option presents a series of potential problems that we have 
addressed previously in the context of the broader challenges regarding 
our ability to price high cost disposable supply items. (For a 
discussion of this issue, we direct the reader to our discussion in the 
CY 2011 PFS final rule with comment period (75 FR 73251)). We stated at 
the time that since the balloon sinus surgery kits can be used when 
furnishing more than one service to the same beneficiary on the same 
day, we believed that it would be appropriate to include 0.5 balloon 
sinus surgery kits for each of the three codes, and we have maintained 
this 0.5 supply quantity when CPT codes 31295-31297 were recently 
reviewed again in CY 2018.
    In light of the additional information supplied by the 
stakeholders, we are soliciting comments on two aspects of the use of 
the balloon sinus surgery kit (SA106) supply. First, we are soliciting 
comments on whether the 0.5 supply quantity of the balloon sinus 
surgery kit in CPT codes 31295-31297 would be typical for these 
procedures. We are concerned that the same kit can be used when 
furnishing more than one service to the same beneficiary on the same 
day, and that even the 0.5 supply quantity may be overstating the 
resources typically needed to furnish each service. Second, we are 
soliciting comments on the pricing of the balloon sinus surgery kit, 
given that we have received letters stating that the price has 
decreased since the initial pricing in the CY 2011 final rule. See 
Table 5 for the current component pricing of the balloon sinus surgery 
kit.

                                Table 5--Balloon Sinus Surgery Kit (SA106) Price
----------------------------------------------------------------------------------------------------------------
              Supply components                  Quantity                    Unit                      Price
----------------------------------------------------------------------------------------------------------------
kit, sinus surgery, balloon (maxillary,       ..............  kit...............................        $2599.86
 frontal, or sphenoid).
Sinus Guide Catheter........................               1  item..............................          444.00
Sinus Balloon Catheter......................               1  item..............................          820.80
Sinus Illumination System (100 cm lighted                  1  item..............................          454.80
 guidewire).
Light Guide Cable (8 ft)....................               1  item..............................          514.80
ACMI/Stryker Adaptor........................               1  item..............................           42.00
Sinus Guide Catheter Handle.................               1  item..............................           66.00
Sinus Irrigation Catheter (22 cm)...........               1  item..............................          150.00
Sinus Balloon Catheter Inflation Device.....               1  item..............................           89.46
Extension Tubing (High Pressure) (20 in)....               1  item..............................           18.00
----------------------------------------------------------------------------------------------------------------

    We are interested in any information regarding possible changes in 
the pricing for this kit or its individual components since the initial 
pricing we adopted in CY 2011.
d. Technical Corrections to Direct PE Input Database and Supporting 
Files
    Subsequent to the publication of the CY 2018 PFS final rule, 
stakeholders alerted us to several clerical inconsistencies in the 
direct PE database. We are proposing to correct these inconsistencies 
as described in this proposed rule and reflected in the CY 2019 
proposed direct PE input database displayed on the CMS website under 
downloads for the CY 2019 PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    For CY 2019, we are proposing to address the following 
inconsistencies:
     The RUC alerted us that there are 165 CPT codes billed 
with an office E/M code more than 50 percent of the time in the 
nonfacility setting that have more minimum multi-specialty visit supply 
packs (SA048) than post-operative visits included in the code's global 
period. This indicates that either the inclusion of office E/M services 
was not accounted for in the code's global period when these codes were 
initially reviewed by the PE Subcommittee, or

[[Page 35716]]

that the PE Subcommittee initially approved a minimum multi-specialty 
visit supply pack for these codes without considering the resulting 
overlap of supplies between SA048 and the E/M supply pack (SA047). The 
RUC regarded these overlapping supply packs as a duplication, due to 
the fact that the quantity of the SA048 supply exceeded the number of 
postoperative visits, and requested that CMS remove the appropriate 
number of supply item SA048 from 165 codes. After reviewing the 
quantity of the SA048 supply pack included for the codes in question, 
we are proposing to refine the quantity of minimum multi-specialty 
visit packs as displayed in Table 6.

                    Table 6--Proposed Refinements--Minimum Multispecialty Visit Pack (SA048)
----------------------------------------------------------------------------------------------------------------
                                                                                                    Proposed CY
                                                                                      CY 2018          2019
                                                                     Number of      nonfacility     nonfacility
                            CPT code                              post-op office    quantity of     quantity of
                                                                      visits       minimum visit   minimum visit
                                                                                   pack (SA048)    pack (SA048)
----------------------------------------------------------------------------------------------------------------
10040...........................................................               1               2               1
10060...........................................................               1               2               1
10061...........................................................               2               3               2
10080...........................................................               1               2               1
10120...........................................................               1               2               1
10121...........................................................               1               2               1
10180...........................................................               1               2               1
11200...........................................................               1               2               1
11300...........................................................               0               1               0
11301...........................................................               0               1               0
11302...........................................................               0               1               0
11303...........................................................               0               1               0
11306...........................................................               0               1               0
11307...........................................................               0               1               0
11310...........................................................               0               1               0
11311...........................................................               0               1               0
11312...........................................................               0               1               0
11400...........................................................               1               2               1
11750...........................................................               1               2               1
11900...........................................................               0               1               0
11901...........................................................               0               1               0
12001...........................................................               0               1               0
12002...........................................................               0               1               0
12004...........................................................               0               1               0
12011...........................................................               0               1               0
12013...........................................................               0               1               0
16020...........................................................               0               1               0
17000...........................................................               1               2               1
17004...........................................................               1               2               1
17110...........................................................               1               2               1
17111...........................................................               1               2               1
17260...........................................................               1               2               1
17270...........................................................               1               2               1
17280...........................................................               1               2               1
19100...........................................................               0               1               0
20005...........................................................               1               2               1
20520...........................................................               1               2               1
21215...........................................................               6               7               6
21550...........................................................               1               2               1
21920...........................................................               1               2               1
22310...........................................................             1.5             2.5             1.5
23500...........................................................             2.5             3.5             2.5
23570...........................................................             2.5             3.5             2.5
23620...........................................................               3               4               3
24500...........................................................               4               5               4
24530...........................................................               4               5               4
24650...........................................................               3               4               3
24670...........................................................               3               4               3
25530...........................................................               3               4               3
25600...........................................................               5               6               5
25605...........................................................               5               6               5
25622...........................................................             3.5             4.5             3.5
25630...........................................................               3               4               3
26600...........................................................               4               5               4
26720...........................................................               2               3               2
26740...........................................................             2.5             3.5             2.5
26750...........................................................               2               3               2
27508...........................................................               4               5               4
27520...........................................................             3.5             4.5             3.5

[[Page 35717]]

 
27530...........................................................               4               5               4
27613...........................................................               1               2               1
27750...........................................................             3.5             4.5             3.5
27760...........................................................               4               5               4
27780...........................................................             3.5             4.5             3.5
27786...........................................................             3.5             4.5             3.5
27808...........................................................               4               5               4
28190...........................................................               1               2               1
28400...........................................................               3               4               3
28450...........................................................             2.5             3.5             2.5
28490...........................................................             1.5             2.5             1.5
28510...........................................................             1.5             2.5             1.5
30901...........................................................               0               1               0
30903...........................................................               0               1               0
30905...........................................................               0               1               0
31000...........................................................               1               2               1
31231...........................................................               0               1               0
31233...........................................................               0               1               0
31235...........................................................               0               1               0
31238...........................................................               0               1               0
31525...........................................................               0               1               0
31622...........................................................               0               1               0
32554...........................................................               0               1               0
36600...........................................................               0               1               0
38220...........................................................               0               1               0
40490...........................................................               0               1               0
42800...........................................................               1               2               1
43200...........................................................               0               1               0
45330...........................................................               0               1               0
46040...........................................................               3               4               3
46050...........................................................               1               2               1
46083...........................................................               1               2               1
46320...........................................................             0.5             1.5             0.5
46600...........................................................               0               1               0
46604...........................................................               0               1               0
46900...........................................................               1               2               1
51102...........................................................               0               2               0
51701...........................................................               0               1               0
51702...........................................................               0               1               0
51703...........................................................               0               1               0
51710...........................................................               0               1               0
51725...........................................................               0               1               0
51736...........................................................               0               1               0
51741...........................................................               0               1               0
51792...........................................................               0               1               0
51798...........................................................               0               1               0
52000...........................................................               0               1               0
52001...........................................................               0               1               0
52214...........................................................               0               1               0
52265...........................................................               0               1               0
52281...........................................................               0               1               0
52285...........................................................               0               1               0
53601...........................................................               0               1               0
53621...........................................................               0               1               0
53660...........................................................               0               1               0
53661...........................................................               0               1               0
54050...........................................................               1               2               1
54056...........................................................               1               2               1
54100...........................................................               0               1               0
54235...........................................................               0               1               0
54450...........................................................               0               1               0
55000...........................................................               0               1               0
56405...........................................................               1               2               1
56605...........................................................               0               1               0
56820...........................................................               0               1               0
57061...........................................................               1               2               1
57100...........................................................               0               1               0

[[Page 35718]]

 
57420...........................................................               0               1               0
57500...........................................................               0               1               0
57505...........................................................               1               2               1
62252...........................................................               0               1               0
62367...........................................................               0               1               0
62368...........................................................               0               1               0
62370...........................................................               0               1               0
64413...........................................................               0               1               0
64420...........................................................               0               1               0
64450...........................................................               0               1               0
64611...........................................................               1               2               1
69000...........................................................               1               2               1
69100...........................................................               0               1               0
69145...........................................................             1.5             2.5             1.5
69210...........................................................               0               1               0
69420...........................................................               1               2               1
69433...........................................................               1               2               1
69610...........................................................               1               2               1
93292...........................................................               0               1               0
93303...........................................................               0               1               0
94667...........................................................               0               1               0
95044...........................................................               0           0.028               0
95870...........................................................               0               1               0
95921...........................................................               0               1               0
95922...........................................................               0               1               0
95924...........................................................               0               1               0
95972...........................................................               0               1               1
96904...........................................................               0               1               1
----------------------------------------------------------------------------------------------------------------

    In general, we are proposing to align the number of minimum multi-
specialty visit packs with the number of post-operative office visits 
included in these codes. We are not proposing any supply pack quantity 
refinements for CPT codes 11100, 95974, or 95978 since they are being 
deleted for CY 2019. We are also not proposing any supply pack quantity 
refinements for CPT codes 45300, 46500, 57150, 57160, 58100, 64405, 
95970, or HCPCS code G0268 since these codes were reviewed by the RUC 
this year and their previous direct PE inputs will be superseded by the 
new direct PE inputs we establish through this rulemaking process for 
CY 2019.
     A stakeholder notified us regarding a potential rank order 
anomaly in the direct PE inputs established for the Shaving of 
Epidermal or Dermal Lesions code family through PFS rulemaking for CY 
2013. Three of these CPT codes describe benign shave removal of 
increasing lesion sizes: CPT code 11310 (Shaving of epidermal or dermal 
lesion, single lesion, face, ears, eyelids, nose, lips, mucous 
membrane; lesion diameter 0.5 cm or less), CPT code 11311 (Shaving of 
epidermal or dermal lesion, single lesion, face, ears, eyelids, nose, 
lips, mucous membrane; lesion diameter 0.6 to 1.0 cm), and CPT code 
11312 (Shaving of epidermal or dermal lesion, single lesion, face, 
ears, eyelids, nose, lips, mucous membrane; lesion diameter 1.1 to 2.0 
cm). Each of these codes has a progressively higher work RVU 
corresponding to the increasing lesion diameter, and the recommended 
direct PE inputs also increase progressively from CPT codes 11310 to 
11311 to 11312. However, the nonfacility PE RVU we established for CPT 
code 11311 is lower than the nonfacility PE RVU for CPT code 11310, 
which the stakeholder suggested may represent a rank order anomaly.
    We reviewed the direct PE inputs for CPT code 11311 and found that 
there were clerical inconsistencies in the data entry that resulted in 
the assignment of the lower nonfacility PE RVU for CPT code 11311. We 
propose to revise the direct PE inputs to reflect the ones previously 
finalized through rulemaking for CPT code 11311.
     In CY 2018, we inadvertently assigned too many minutes of 
clinical labor time for the ``Obtain vital signs'' task to three 
therapy codes, given that these codes are typically billed in multiple 
units and in conjunction with other therapy codes for the same patient 
on the same day, and we do not believe that it would be typical for 
clinical staff to obtain vital signs for each time a code is reported. 
The codes are: CPT code 97124 (Therapeutic procedure, 1 or more areas, 
each 15 minutes; massage, including effleurage, petrissage and/or 
tapotement (stroking, compression, percussion)); CPT code 97750 
(Physical performance test or measurement (e.g., musculoskeletal, 
functional capacity), with written report, each 15 minutes); and CPT 
code 97755 (Assistive technology assessment (e.g., to restore, augment 
or compensate for existing function, optimize functional tasks and/or 
maximize environmental accessibility), direct one-on-one contact, with 
written report, each 15 minutes).
    Therefore, we are proposing to refine the ``Obtain vital signs'' 
clinical labor task for these three codes back to their previous times 
of 1 minute for CPT codes 97124 and 97750 and to 3 minutes for CPT code 
97755. We are also proposing to refine the equipment time for the 
table, mat, hi-lo, 6 x 8 platform (EF028) for CPT code 97124 to reflect 
the change in the clinical labor time.
     We received a letter from a stakeholder alerting us to an 
anomaly in

[[Page 35719]]

the direct PE inputs for CPT code 52000 (Cystourethroscopy (separate 
procedure)). The stakeholder stated that the inclusion of an endoscope 
disinfector, rigid or fiberoptic, w-cart equipment item (ES005) was 
inadvertently overlooked in the recommendations for CPT code 52000 when 
it was reviewed during PFS rulemaking for CY 2017, and that the 
equipment would be necessary for endoscope sterilization. The 
stakeholder requested that this essential piece of equipment should be 
added to the direct PE inputs for CPT code 52000.
    After reviewing the direct PE inputs for this code, we agree with 
the stakeholder and we are proposing to add the endoscope disinfector 
(ES005) to CPT code 52000, and to add 22 minutes of equipment time for 
that item to match the equipment time of the other non-scope items 
included in this code.
e. Updates to Prices for Existing Direct PE Inputs
    In the CY 2011 PFS final rule with comment period (75 FR 73205), we 
finalized a process to act on public requests to update equipment and 
supply price and equipment useful life inputs through annual 
rulemaking, beginning with the CY 2012 PFS proposed rule. For CY 2019, 
we are proposing the following price updates for existing direct PE 
inputs.
    We are proposing to update the price of four supplies and one 
equipment item in response to the public submission of invoices. As 
these pricing updates were each part of the formal review for a code 
family, we are proposing that the new pricing take effect for CY 2019 
for these items instead of being phased in over 4 years. For the 
details of these proposed price updates, please refer to section II.H 
of this proposed rule Table 16: Invoices Received for Existing Direct 
PE Inputs.
(1) Market-Based Supply and Equipment Pricing Update
    Section 220(a) of the Protecting Access to Medicare Act of 2014 
(PAMA) provides that the Secretary may collect or obtain information 
from any eligible professional or any other source on the resources 
directly or indirectly related to furnishing services for which payment 
is made under the PFS, and that such information may be used in the 
determination of relative values for services under the PFS. Such 
information may include the time involved in furnishing services; the 
amounts, types and prices of PE inputs; overhead and accounting 
information for practices of physicians and other suppliers, and any 
other elements that would improve the valuation of services under the 
PFS.
    As part of our authority under section 1848(c)(2)(M) of the Act, as 
added by the PAMA, we initiated a market research contract with 
StrategyGen to conduct an in-depth and robust market research study to 
update the PFS direct PE inputs (DPEI) for supply and equipment pricing 
for CY 2019. These supply and equipment prices were last systematically 
developed in 2004-2005. StrategyGen has submitted a report with updated 
pricing recommendations for approximately 1300 supplies and 750 
equipment items currently used as direct PE inputs. This report is 
available as a public use file displayed on the CMS website under 
downloads for the CY 2019 PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    The StrategyGen team of researchers, attorneys, physicians, and 
health policy experts conducted a market research study of the supply 
and equipment items currently used in the PFS direct PE input database. 
Resources and methodologies included field surveys, aggregate 
databases, vendor resources, market scans, market analysis, physician 
substantiation, and statistical analysis to estimate and validate 
current prices for medical equipment and medical supplies. StrategyGen 
conducted secondary market research on each of the 2,072 DPEI medical 
equipment and supply items that CMS identified from the current DPEI. 
The primary and secondary resources StrategyGen used to gather price 
data and other information were:
     Telephone surveys with vendors for top priority items 
(Vendor Survey).
     Physician panel validation of market research results, 
prioritized by total spending (Physician Panel).
     The General Services Administration system (GSA).
     An aggregate health system buyers database with discounted 
prices (Buyers).
     Publicly available vendor resources, that is, Amazon 
Business, Cardinal Health (Vendors).
     Federal Register, current DPEI data, historical proposed 
and final rules prior to FY 2018, and other resources; that is, AMA RUC 
reports (References).
    StrategyGen prioritized the equipment and supply research based on 
current share of PE RVUs attributable by item provided by CMS. 
StrategyGen developed the preliminary Recommended Price (RP) 
methodology based on the following rules in hierarchical order 
considering both data representativeness and reliability:
    1. If the market share, as well as the sample size, for the top 
three commercial products were available, the weighted average price 
(weighted by percent market share) was the reported RP. Commercial 
price, as a weighted average of market share, represents a more robust 
estimate for each piece of equipment and a more precise reference for 
the RP.
    2. If StrategyGen did not have market share for commercial 
products, then they used a weighted average (weighted by sample size) 
of the commercial price and GSA price for the RP. The impact of the GSA 
price may be nominal in some of these cases since it is proportionate 
to the commercial samples sizes.
    3. Otherwise, if single price points existed from alternate 
supplier sites, the RP was the weighted average of the commercial price 
and the GSA price.
    4. Finally, if no data were available for commercial products, the 
GSA average price was used as the RP; and when StrategyGen could find 
no market research for a particular piece of equipment or supply item, 
the current CMS prices were used as the RP.
    StrategyGen found that despite technological advancements, the 
average commercial price for medical equipment and supplies has 
remained relatively consistent with the current CMS price. 
Specifically, preliminary data indicate that there was no statistically 
significant difference between the estimated commercial prices and the 
current CMS prices for both equipment and supplies. This cumulative 
stable pricing for medical equipment and supplies appears similar to 
the pricing impacts of non-medical technology advancements where some 
historically high-priced equipment (that is, desktop PCs) has been 
increasingly substituted with current technology (that is, laptops and 
tablets) at similar or lower price points. However, while there were no 
statistically significant differences in pricing at the aggregate 
level, medical specialties will experience increases or decreases in 
their Medicare payments if CMS were to adopt the pricing updates 
recommended by StrategyGen. At the service level, there may be large 
shifts in PE RVUs for individual codes that happened to contain 
supplies and/or equipment with major changes in pricing, although we 
note that codes with a sizable PE RVU decrease would be limited by the 
requirement to phase in significant reductions in RVUs, as required by 
section 1848(c)(7) of the Act. The phase-in requirement limits the 
maximum

[[Page 35720]]

RVU reduction for codes that are not new or revised to 19 percent in 
any individual calendar year.
    After reviewing the StrategyGen report, we are proposing to adopt 
the updated direct PE input prices for supplies and equipment as 
recommended by StrategyGen. We believe that it is important to make use 
of the most current information available for supply and equipment 
pricing instead of continuing to rely on pricing information that is 
more than a decade old. Given the potentially significant changes in 
payment that would occur, both for specific services and more broadly 
at the specialty level, we are proposing to phase in our use of the new 
direct PE input pricing over a 4-year period using a 25/75 percent (CY 
2019), 50/50 percent (CY 2020), 75/25 percent (CY 2021), and 100/0 
percent (CY 2022) split between new and old pricing. This approach is 
consistent with how we have previously incorporated significant new 
data into the calculation of PE RVUs, such as the 4-year transition 
period finalized in CY 2007 PFS final rule with comment period when 
changing to the ``bottom-up'' PE methodology (71 FR 69641). This 
transition period will not only ease the shift to the updated supply 
and equipment pricing, but will also allow interested parties an 
opportunity to review and respond to the new pricing information 
associated with their services.
    We are proposing to implement this phase-in over 4 years so that 
supply and equipment values transition smoothly from the prices we 
currently include to the final updated prices in CY 2022. We are 
proposing to implement this pricing transition such that one quarter of 
the difference between the current price and the fully phased in price 
is implemented for CY 2019, one third of the difference between the CY 
2019 price and the final price is implemented for CY 2020, and one half 
of the difference between the CY 2020 price and the final price is 
implemented for CY 2021, with the new direct PE prices fully 
implemented for CY 2022. An example of the proposed transition from the 
current to the fully-implemented new pricing is provided in Table 7.

            Table 7--Example of Direct PE Pricing Transition
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Current Price.....................            $100  ....................
Final Price.......................             200  ....................
Year 1 (CY 2019) Price............             125  \1/4\ difference
                                                     between $100 and
                                                     $200.
Year 2 (CY 2020) Price............             150  \1/3\ difference
                                                     between $125 and
                                                     $200.
Year 3 (CY 2021) Price............             175  \1/2\ difference
                                                     between $150 and
                                                     $200.
Final (CY 2022) Price.............             200  ....................
------------------------------------------------------------------------

    For new supply and equipment codes for which we establish prices 
during the transition years (CYs 2019, 2020 and 2021) based on the 
public submission of invoices, we are proposing to fully implement 
those prices with no transition since there are no current prices for 
these supply and equipment items. These new supply and equipment codes 
would immediately be priced at their newly established values. We are 
also proposing that, for existing supply and equipment codes, when we 
establish prices based on invoices that are submitted as part of a 
revaluation or comprehensive review of a code or code family, they will 
be fully implemented for the year they are adopted without being phased 
in over the 4-year pricing transition. The formal review process for a 
HCPCS code includes a review of pricing of the supplies and equipment 
included in the code. When we find that the price on the submitted 
invoice is typical for the item in question, we believe it would be 
appropriate to finalize the new pricing immediately along with any 
other revisions we adopt for the code valuation.
    For existing supply and equipment codes that are not part of a 
comprehensive review and valuation of a code family and for which we 
establish prices based on invoices submitted by the public, we are 
proposing to implement the established invoice price as the updated 
price and to phase in the new price over the remaining years of the 
proposed 4-year pricing transition. During the proposed transition 
period, where price changes for supplies and equipment are adopted 
without a formal review of the HCPCS codes that include them (as is the 
case for the many updated prices we are proposing to phase in over the 
4-year transition period), we believe it is important to include them 
in the remaining transition toward the updated price. We are also 
proposing to phase in any updated pricing we establish during 4-year 
transition period for very commonly used supplies and equipment that 
are included in 100 or more codes, such as sterile gloves (SB024) or 
exam tables (EF023), even if invoices are provided as part of the 
formal review of a code family. We would implement the new prices for 
any such supplies and equipment over the remaining years of the 
proposed 4-year transition period. Our proposal is intended to minimize 
any potential disruptive effects during the proposed transition period 
that could be caused by other sudden shifts in RVUs due to the high 
number of services that make use of these very common supply and 
equipment items (meaning that these items are included in 100 or more 
codes).
    We believe that implementing the proposed updated prices with a 4-
year phase-in will improve payment accuracy, while maintaining 
stability and allowing stakeholders the opportunity to address 
potential concerns about changes in payment for particular items. 
Updating the pricing of direct PE inputs for supplies and equipment 
over a longer time frame will allow more opportunities for public 
comment and submission of additional, applicable data. We welcome 
feedback from stakeholders on the proposed updated supply and equipment 
pricing, including the submission of additional invoices for 
consideration. We are particularly interested in comments regarding the 
supply and equipment pricing for CPT codes 95165 and 95004 that are 
frequently used by the Allergy/Immunology specialty. The Allergy/
Immunology specialty was disproportionately affected by the updated 
pricing, even with a 4-year phase-in. The direct PE costs for CPT code 
95165 would go down from $8.43 to $8.17 as a result of the updated 
supply and equipment pricing information. This would result in the PE 
RVU for CPT code 96165 to decrease from 0.30 to 0.26. We are seeking 
feedback on the supply and equipment pricing for the affected codes 
typically performed by this specialty and whether the direct PE inputs 
should be reviewed along with the pricing. The full report from the 
contractor, including the updated supply and equipment pricing as it is 
proposed to be implemented over the proposed 4-year transition period, 
will be made available as a public use file displayed on the CMS 
website

[[Page 35721]]

under downloads for the CY 2019 PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    To maintain relativity between the clinical labor, supplies, and 
equipment portions of the PE methodology, we believe that the rates for 
the clinical labor staff should also be updated along with the updated 
pricing for supplies and equipment. We seek public comment regarding 
whether to update the clinical labor wages used in developing PE RVUs 
in future calendar years during the 4-year pricing transition for 
supplies and equipment, or whether it would be more appropriate to 
update the clinical labor wages at a later date following the 
conclusion of the transition for supplies and equipment, for example, 
to avoid other potentially large shifts in PE RVUs during the 4-year 
pricing transition period.
(2) Breast Biopsy Software (EQ370)
    Following the publication of the CY 2018 PFS final rule, a 
stakeholder contacted us and requested that we update the price for the 
Breast Biopsy software (EQ370) equipment. This equipment item currently 
lacks a price in the direct PE database, and when an invoice for the 
Breast Biopsy software was first submitted during the CY 2014 PFS rule, 
we stated that this item served clinical functions similar to other 
items already included in the Magnetic Resonance (MR) room equipment 
package (EL008) included in the same CPT codes under review. Therefore, 
we did not create new direct PE inputs for this equipment item (78 FR 
74344 through 74345). The stakeholder suggested that this software is 
used to subtract the imaging raw data series from the MRI Scanner, 
reformat the images in multiple planes to allow accurate targeting of 
the lesion to be biopsied, identify the location of a fiducial marker 
on the patient's skin, and then target the location of the enhancing 
lesion to be biopsied. The stakeholder requested that EQ370 be renamed 
as ``Breast MRI computer aided detection and biopsy guidance software'' 
and added to existing CPT codes 19085 (Biopsy, breast, with placement 
of breast localization device(s) (e.g., clip, metallic pellet), when 
performed, and imaging of the biopsy specimen, when performed, 
percutaneous; first lesion, including magnetic resonance guidance), 
19086 (Biopsy, breast, with placement of breast localization device(s) 
(e.g., clip, metallic pellet), when performed, and imaging of the 
biopsy specimen, when performed, percutaneous; each additional lesion, 
including magnetic resonance guidance), 19287 (Placement of breast 
localization device(s) (e.g., clip, metallic pellet, wire/needle, 
radioactive seeds), percutaneous; first lesion, including magnetic 
resonance guidance), and 19288 (Placement of breast localization 
device(s) (e.g., clip, metallic pellet, wire/needle, radioactive 
seeds), percutaneous; each additional lesion, including magnetic 
resonance guidance), as well as adding the equipment to two newly 
created MR breast codes with CAD, CPT codes 77X51 (Magnetic resonance 
imaging, breast, without and with contrast material(s), including 
computer-aided detection (CAD-real time lesion detection, 
characterization and pharmacokinetic analysis) when performed; 
unilateral) and 77X52 (Magnetic resonance imaging, breast, without and 
with contrast material(s), including computer-aided detection (CAD-real 
time lesion detection, characterization and pharmacokinetic analysis) 
when performed; bilateral). The stakeholder supplied an invoice with a 
purchase price of $52,275 for the equipment.
    After reviewing the use of the Breast Biopsy software (EQ370) 
equipment in these six codes, we are not proposing to update the price 
or add the software to these procedures. As we stated in the CY 2014 
PFS final rule with comment period (78 FR 74345), we continue to 
believe that equipment item EQ370 serves clinical functions similar to 
other items already included in the MR room equipment package (EL008), 
and that it would be duplicative to include this Breast Biopsy software 
as a separate direct PE input. We also note that the RUC 
recommendations for the new CPT codes 77X51 and 77X52 do not include 
EQ370 in the recommended equipment for these procedures, and we do not 
have any reason to believe that the inclusion of additional Breast 
Biopsy software beyond what is already contained in the MR room 
equipment package would be typical. However, we will update the name of 
the EQ370 equipment item from ``Breast Biopsy software'' to the 
requested ``Breast MRI computer aided detection and biopsy guidance 
software'' to help better describe the equipment in question.
(3) Invoice Submission
    We routinely accept public submission of invoices as part of our 
process for developing payment rates for new, revised, and potentially 
misvalued codes. Often these invoices are submitted in conjunction with 
the RUC-recommended values for the codes. For CY 2019, we note that 
some stakeholders have submitted invoices for new, revised, or 
potentially misvalued codes after the February 10th deadline 
established for code valuation recommendations. To be included in a 
given year's proposed rule, we generally need to receive invoices by 
the same February 10th deadline we noted for consideration of RUC 
recommendations. However, we would consider invoices submitted as 
public comments during the comment period following the publication of 
this proposed rule, and would consider any invoices received after 
February 10 or outside of the public comment process as part of our 
established annual process for requests to update supply and equipment 
prices.
4. Adjustment to Allocation of Indirect PE for Some Office-Based 
Services
    In the CY 2018 PFS final rule (82 FR 52999 through 53000), we 
established criteria for identifying the services most affected by the 
indirect PE allocation anomaly that does not allow for a site of 
service differential that accurately reflects the relative indirect 
costs involved in furnishing services in nonfacility settings. We also 
finalized a modification in the PE methodology for allocating indirect 
PE RVUS to better reflect the relative indirect PE resources involved 
in furnishing these services. The methodology, as described, is based 
on the difference between the ratio of indirect PE to work RVUs for 
each of the codes meeting eligibility criteria and the ratio of 
indirect PE to work RVU for the most commonly reported visit code. We 
refer readers to the CY 2018 PFS final rule (82 FR 52999 through 53000) 
for a discussion of our process for selecting services subject to the 
revised methodology, as well as a description of the methodology, which 
we began implementing for CY 2018 as the first year of a 4-year 
transition. For CY 2019, we are proposing to continue with the second 
year of the transition of this adjustment to the standard process for 
allocating indirect PE.

C. Determination of Malpractice Relative Value Units (RVUs)

1. Overview
    Section 1848(c) of the Act requires that the payment amount for 
each service paid under the PFS be composed of three components: Work; 
PE; and malpractice (MP) expense. As required by section 
1848(c)(2)(C)(iii) of the Act, beginning in CY 2000, MP RVUs are 
resource-based. Section 1848(c)(2)(B)(i) of the Act also requires that 
we review, and if necessary adjust, RVUs no less often than every 5 
years. In the CY 2015

[[Page 35722]]

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

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

    The health care community uses the term ``telehealth'' broadly to 
refer to medical services furnished via communication technology. Under 
current PFS payment rules, Medicare routinely pays for many of these 
kinds of services. This includes some kinds of remote patient 
monitoring (either as separate services or as parts of bundled 
services), interpretations of diagnostic tests when furnished remotely, 
and, under conditions specified in section 1834(m) of the Act, services 
that would otherwise be furnished in person but are instead furnished 
via real-time, interactive communication technology. Over the past 
several years, CMS has also established several PFS policies to 
explicitly pay for non-face-to-face services included as part of 
ongoing care management.
    While all of the kinds of services stated above might be called 
``telehealth'' by patients, other payers and health care providers, we 
have generally used the term ``Medicare telehealth services'' to refer 
to the subset of services defined in section 1834(m) of the Act. 
Section 1834(m) of the Act defines Medicare telehealth services and 
specifies the payment amounts and circumstances under which Medicare 
makes payment for a discrete set of services, all of which must 
ordinarily be furnished in-person, when they are instead furnished 
using interactive, real-time telecommunication technology. Section 
1834(m)(4)(F)(i) of the Act enumerates certain Medicare telehealth 
services and section 1834(m)(4)(F)(ii) of the Act allows the Secretary 
to specify additional Medicare telehealth services using an annual 
process to add or delete services from the Medicare telehealth list. 
Section 1834(m)(4)(C) of the Act limits the scope of Medicare 
telehealth services for which payment may be made to those furnished to 
a beneficiary who is located in certain types of originating sites in 
certain, mostly rural, areas. Section 1834(m)(1) of the Act permits 
only physicians and certain other types of practitioners to furnish and 
be paid for Medicare telehealth services. Although section 
1834(m)(4)(F)(ii) of the Act grants the Secretary the authority to add 
services to, and delete services from, the list of telehealth services 
based on the established annual process, it does not provide any 
authority to change the limitations relating to geography, patient 
setting, or type of furnishing practitioner because these requirements 
are specified in statute. However, we note that sections 50302, 50324, 
and 50325 of the Bipartisan Budget Act of 2018 (BBA 18) have modified 
or removed the limitations relating to geography and patient setting 
for certain telehealth services, including for certain home dialysis 
end-stage renal disease-related services, services furnished by 
practitioners in certain Accountable Care Organizations, and acute 
stroke-related services, respectively.
    In the CY 2018 PFS proposed rule, we sought information from the 
public regarding ways that we might further expand access to telehealth 
services within the current statutory authority and pay appropriately 
for services that take full advantage of communication technologies. 
Commenters were very supportive of CMS expanding access to these kinds 
of services. Many

[[Page 35723]]

commenters noted that Medicare payment for telehealth services is 
restricted by statute, but encouraged CMS to recognize and support 
technological developments in healthcare.
    We believe that the provisions in section 1834(m) of the Act apply 
particularly to the kinds of professional services explicitly 
enumerated in the statutory provisions, like professional 
consultations, office visits, and office psychiatry services. 
Generally, the services we have added to the telehealth list are 
similar to these kinds of services. As has long been the case, certain 
other kinds of services that are furnished remotely using 
communications technology are not considered ``Medicare telehealth 
services'' and are not subject to the restrictions articulated in 
section 1834(m) of the Act. This is true for services that were 
routinely paid separately prior to the enactment of the provisions in 
section 1834(m) of the Act and do not usually include patient 
interaction (such as remote interpretation of diagnostic imaging 
tests), and for services that were not discretely defined or separately 
paid for at the time of enactment and that do include patient 
interaction (such as chronic care management services).
    As we considered the concerns expressed by commenters about the 
statutory restrictions on Medicare telehealth services, we recognized 
that the concerns were not limited to the barriers to payment for 
remotely furnished services like those described by the office visit 
codes. The commenters also expressed concerns pertaining to the 
limitations on appropriate payment for evolving physicians' services 
that are inherently furnished via communication technology, especially 
as technology and its uses have evolved in the decades since the 
Medicare telehealth services statutory provision was enacted.
    In recent years, we have sought to recognize significant changes in 
health care practice, especially innovations in the active management 
and ongoing care of chronically ill patients, and have relied on the 
medical community to identify and define discrete physicians' services 
through the CPT Editorial Panel (82 FR 53163). In response to our 
comment solicitation on Medicare telehealth services in the CY 2018 PFS 
proposed rule (82 FR 53012), commenters provided many suggestions for 
how CMS could expand access to telehealth services within the current 
statutory authority and pay appropriately for services that take full 
advantage of communication technologies, such as waiving portions of 
the statutory restrictions using demonstration authority. After 
considering those comments we recognize that concerns regarding the 
provisions in section 1834(m) of the Act may have been limiting the 
degree to which the medical community developed coding for new kinds of 
services that inherently utilize communication technology. We have come 
to believe that section 1834(m) of the Act does not apply to all kinds 
of physicians' services whereby a medical professional interacts with a 
patient via remote communication technology. Instead, we believe that 
section 1834(m) of the Act applies to a discrete set of physicians' 
services that ordinarily involve, and are defined, coded, and paid for 
as if they were furnished during an in-person encounter between a 
patient and a health care professional.
    For CY 2019, we are aiming to increase access for Medicare 
beneficiaries to physicians' services that are routinely furnished via 
communication technology by clearly recognizing a discrete set of 
services that are defined by and inherently involve the use of 
communication technology. Accordingly, we have several proposals for 
modernizing Medicare physician payment for communication technology-
based services, described below. These services would not be subject to 
the limitations on Medicare telehealth services in section 1834(m) of 
the Act because, as we have explained, we do not consider them to be 
Medicare telehealth services; instead, they would be paid under the PFS 
like other physicians' services. Additionally, we note that in 
furnishing these proposed services, practitioners would need to comply 
with any applicable privacy and security laws, including the HIPAA 
Privacy Rule.
1. Brief Communication Technology-Based Service, e.g., Virtual Check-In 
(HCPCS Code GVCI1)
    The traditional office visit codes describe a broad range of 
physicians' services. Historically, we have considered any routine non-
face-to-face communication that takes place before or after an in-
person visit to be bundled into the payment for the visit itself. In 
recent years, we have recognized payment disparities that arise when 
the amount of non-face-to-face work for certain kinds of patients is 
disproportionately higher than for others, and created coding and 
separate payment to recognize care management services such as chronic 
care management and behavioral health integration services (81 FR 
80226). We now recognize that advances in communication technology have 
changed patients' and practitioners' expectations regarding the 
quantity and quality of information that can be conveyed via 
communication technology. From the ubiquity of synchronous, audio/video 
applications to the increased use of patient-facing health portals, a 
broader range of services can be furnished by health care professionals 
via communication technology as compared to 20 years ago.
    Among these services are the kinds of brief check-in services 
furnished using communication technology that are used to evaluate 
whether or not an office visit or other service is warranted. When 
these kinds of check-in services are furnished prior to an office 
visit, then we would currently consider them to be bundled into the 
payment for the resulting visit, such as through an evaluation and 
management (E/M) visit code. However, in cases where the check-in 
service does not lead to an office visit, then there is no office visit 
with which the check-in service can be bundled. To the extent that 
these kinds of check-ins become more effective at addressing patient 
concerns and needs using evolving technology, we believe that the 
overall payment implications of considering the services to be broadly 
bundled becomes more problematic. This is especially true in a 
resource-based relative value payment system. Effectively, the better 
practitioners are in leveraging technology to furnish effective check-
ins that mitigate the need for potentially unnecessary office visits, 
the fewer billable services they furnish. Given the evolving 
technological landscape, we believe this creates incentives that are 
inconsistent with current trends in medical practice and potentially 
undermines payment accuracy.
    Therefore, we are proposing to pay separately, beginning January 1, 
2019, for a newly defined type of physicians' service furnished using 
communication technology. This service would be billable when a 
physician or other qualified health care professional has a brief non-
face-to-face check-in with a patient via communication technology, to 
assess whether the patient's condition necessitates an office visit. We 
understand that the kinds of communication technology used to furnish 
these kinds of services has broadened over time and has enhanced the 
capacity for medical professionals to care for patients. We are seeking 
comment on what types of communication technology are utilized by 
physicians or other qualified health care professionals in furnishing 
these

[[Page 35724]]

services, including whether audio-only telephone interactions are 
sufficient compared to interactions that are enhanced with video or 
other kinds of data transmission.
    The proposed code would be described as GVCI1 (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 further propose that in instances when the brief 
communication technology-based service originates from a related E/M 
service provided within the previous 7 days by the same physician or 
other qualified health care professional, that this service would be 
considered bundled into that previous E/M service and would not be 
separately billable, which is consistent with code descriptor language 
for CPT code 99441 (Telephone evaluation and management service by a 
physician or other qualified health care professional who may report 
evaluation and management services provided to an established patient, 
parent, or guardian 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) on which this service is partially modeled. We 
propose that in instances when the brief communication technology-based 
service leads to an E/M in-person service with the same physician or 
other qualified health care professional, this service would be 
considered bundled into the pre- or post-visit time of the associated 
E/M service, and therefore, would not be separately billable. We also 
note that this service could be used as part of a treatment regimen for 
opioid use disorders and other substance use disorders, since there are 
several components of Medication Assisted Therapy (MAT) that could be 
done virtually, or to assess whether the patient's condition requires 
an office visit.
    We propose pricing this distinct service at a rate lower than 
existing E/M in-person visits to reflect the low work time and 
intensity and to account for the resource costs and efficiencies 
associated with the use of communication technology. We expect that 
these services would be initiated by the patient, especially since many 
beneficiaries would be financially liable for sharing in the cost of 
these services. For the same reason, we believe it is important for 
patients to consent to receiving these services, and we are 
specifically seeking comment on whether we should require, for example, 
verbal consent that would be noted in the medical record for each 
service. We are also proposing that this service can only be furnished 
for established patients because we believe that the practitioner needs 
to have an existing relationship with the patient, and therefore, basic 
knowledge of the patient's medical condition and needs, in order to 
perform this service. We are not proposing to apply a frequency limit 
on the use of this code by the same practitioner with the same patient, 
but we want to ensure that this code is appropriately utilized for 
circumstances when a patient needs a brief non-face-to-face check-in to 
assess whether an office visit is necessary. We are seeking comment on 
whether it would be clinically appropriate to apply a frequency 
limitation on the use of this code by the same practitioner with the 
same patient, and on what would be a reasonable frequency limitation. 
We are also seeking comment on the timeframes under which this service 
would be separately billable compared to when it would be bundled. We 
believe the general construct of bundling the services that lead 
directly to a billable visit is important, but we are concerned that 
establishing strict timeframes may create unintended consequences 
regarding scheduling of care. For example, we do not want to bundle 
only the services that occur within 24 hours of a visit only to see a 
significant number of visits occurring at 25 hours after the initial 
service. In order to mitigate these incentives, we are seeking comment 
on whether we should consider broadening the window of time and/or 
circumstances in which this service should be bundled into the 
subsequent related visit. We note that these services, like any other 
physicians' service, would need to be medically reasonable and 
necessary in order to be paid by Medicare. We are seeking comment on 
how clinicians could best document the medical necessity of this 
service, consistent with documentation requirements necessary to 
demonstrate the medical necessity of any service under the PFS. For 
details related to developing utilization estimates for these services, 
see section VII. Regulatory Impact Analysis, of this proposed rule. For 
additional details related to valuation of these services, see section 
II.H. Valuation of Specific Codes, of this proposed rule. We are 
seeking comment on our proposed definition and valuation of this code.
2. Remote Evaluation of Pre-Recorded Patient Information (HCPCS Code 
GRAS1)
    Stakeholders have requested that CMS make separate Medicare payment 
when a physician uses recorded video and/or images captured by a 
patient in order to evaluate a patient's condition. These services 
involve what is referred to under section 1834(m) of the Act as 
``store-and-forward'' communication technology that provides for the 
``asynchronous transmission of health care information.'' We note that 
we believe these services involve pre-recorded patient-generated still 
or video images. Other types of patient-generated information, such as 
information from heart rate monitors or other devices that collect 
patient health marker data, could potentially be reported with CPT 
codes that describe remote patient monitoring. Under section 1834(m) of 
the Act, payment for telehealth services furnished using such store-
and-forward technology is permitted only under Federal telemedicine 
demonstration programs conducted in Alaska or Hawaii, and these 
telehealth services remain subject to the other statutory restrictions 
governing Medicare telehealth services. Much like the virtual check-in 
described above, these services are not meant to substitute for an in-
person service currently separately payable under the PFS, and 
therefore, are distinct from the telehealth services described under 
section 1834(m) of the Act. Effective January 1, 2019, we are proposing 
to create specific coding that describes the remote professional 
evaluation of patient-transmitted information conducted via pre-
recorded ``store and forward'' video or image technology. These 
services would not be subject to the Medicare telehealth restrictions 
in section 1834(m) of the Act, and the valuation would reflect the 
resource costs associated with furnishing services utilizing 
communication technology.
    Much like the brief communication technology-based services 
discussed above, these services may be used to determine whether or not 
an office visit or other service is warranted. When the review of the 
patient-submitted image and/or video results in an in-person E/M office 
visit with the same physician or qualified health care professional, we 
propose that this remote service would be considered bundled into that 
office visit and therefore would not be separately billable. We further 
propose

[[Page 35725]]

that in instances when the remote service originates from a related E/M 
service provided within the previous 7 days by the same physician or 
qualified health care professional, that this service would be 
considered bundled into that previous E/M service and also would not be 
separately billable. In summary, we propose this service to be a stand-
alone service that could be separately billed to the extent that there 
is no resulting E/M office visit and there is no related E/M office 
visit within the previous 7 days of the remote service being furnished. 
The proposed coding and separate payment for this service is consistent 
with the progression of technology and its impact on the practice of 
medicine in recent years, and would result in increased access to 
services for Medicare beneficiaries. The proposed code for this service 
would be described as GRAS1 (Remote evaluation of recorded video and/or 
images submitted by the patient (e.g., store and forward), including 
interpretation with verbal 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 are 
seeking comment as to whether these services should be limited to 
established patients; or whether there are certain cases, like 
dermatological or ophthalmological services, where it might be 
appropriate for a new patient to receive these services. For example, 
when a patient seeks care for a specific skin condition from a 
dermatologist with whom she does not have a prior relationship, and 
part of the inquiry is an assessment of whether the patient needs an 
in-person visit, the patient could share, and the dermatologist could 
remotely evaluate, pre-recorded information. We also note that this 
service is distinct from the brief communication technology-based 
service described above in that this service involves the 
practitioner's evaluation of a patient-generated still or video image, 
and the subsequent communication of the resulting response to the 
patient, while the brief communication technology-based service 
describes a service that occurs in real time and does not involve the 
transmission of any recorded image.
    For details related to developing utilization estimates for these 
services, see section VII. Regulatory Impact Analysis, of this proposed 
rule. For further discussion related to valuation of this service, 
please see the section II.H. Valuation of Specific Codes, of this 
proposed rule. We are seeking public comment on our proposed definition 
and valuation of the code.
3. Interprofessional Internet Consultation (CPT Codes 994X6, 994X0, 
99446, 99447, 99448, and 99449)
    As part of our standard rulemaking process, we received 
recommendations from the RUC to assist in establishing values for six 
CPT codes that describe interprofessional consultations. In 2013, CMS 
received recommendations from the RUC for CPT codes 99446 
(Interprofessional telephone/internet assessment and management service 
provided by a consultative physician including a verbal and written 
report to the patient's treating/requesting physician or other 
qualified health care professional; 5-10 minutes of medical 
consultative discussion and review), 99447 (Interprofessional 
telephone/internet assessment and management service provided by a 
consultative physician including a verbal and written report to the 
patient's treating/requesting physician or other qualified health care 
professional; 11-20 minutes of medical consultative discussion and 
review), 99448 (Interprofessional telephone/internet assessment and 
management service provided by a consultative physician including a 
verbal and written report to the patient's treating/requesting 
physician or other qualified health care professional; 21-30 minutes of 
medical consultative discussion and review), and 99449 
(Interprofessional telephone/internet assessment and management service 
provided by a consultative physician including a verbal and written 
report to the patient's treating/requesting physician or other 
qualified health care professional; 31 minutes or more of medical 
consultative discussion and review). CMS declined to make separate 
payment, stating in the CY 2014 PFS final rule with comment period that 
these kinds of services are considered bundled (78 FR 74343). For CY 
2019, the CPT Editorial Panel created two new codes to describe 
additional consultative services, including a code describing the work 
of the treating physician when initiating a consult, and the RUC 
recommended valuation for new codes, CPT codes 994X0 (Interprofessional 
telephone/internet/electronic health record referral service(s) 
provided by a treating/requesting physician or qualified health care 
professional, 30 minutes) and 994X6 (Interprofessional telephone/
internet/electronic health record assessment and management service 
provided by a consultative physician including a written report to the 
patient's treating/requesting physician or other qualified health care 
professional, 5 or more minutes of medical consultative time). The RUC 
also reaffirmed their prior recommendations for the existing CPT codes. 
The six codes describe assessment and management services conducted 
through telephone, internet, or electronic health record consultations 
furnished when a patient's treating physician or other qualified 
healthcare professional requests the opinion and/or treatment advice of 
a consulting physician or qualified healthcare professional with 
specific specialty expertise to assist with the diagnosis and/or 
management of the patient's problem without the need for the patient's 
face-to-face contact with the consulting physician or qualified 
healthcare professional. Currently, the resource costs associated with 
seeking or providing such a consultation are considered bundled, which 
in practical terms means that specialist input is often sought through 
scheduling a separate visit for the patient when a phone or internet-
based interaction between the treating practitioner and the consulting 
practitioner would have been sufficient. We believe that proposing 
payment for these interprofessional consultations performed via 
communications technology such as telephone or internet is consistent 
with our ongoing efforts to recognize and reflect medical practice 
trends in primary care and patient-centered care management within the 
PFS.
    Beginning in the CY 2012 PFS proposed rule (76 FR 42793), we have 
recognized the changing focus in medical practice toward managing 
patients' chronic conditions, many of which particularly challenge the 
Medicare population, including heart disease, diabetes, respiratory 
disease, breast cancer, allergies, Alzheimer's disease, and factors 
associated with obesity. We have expressed concerns that the current E/
M coding does not adequately reflect the changes that have occurred in 
medical practice, and the activities and resource costs associated with 
the treatment of these complex patients in the primary care setting. In 
the years since 2012, we have acknowledged the shift in medical 
practice away from an episodic treatment-based approach to one that 
involves comprehensive patient-centered care management, and have taken 
steps through rulemaking to better reflect that approach in payment 
under the PFS. In CY 2013, we established new codes to pay separately 
for transitional care management (TCM)

[[Page 35726]]

services. Next, we finalized new coding and separate payment beginning 
in CY 2015 for chronic care management (CCM) services provided by 
clinical staff (81 FR 80226). In the CY 2017 PFS final rule, we 
established separate payment for complex CCM services, an add-on code 
to the visit during which CCM is initiated to reflect the work of the 
billing practitioner in assessing the beneficiary and establishing the 
CCM care plan, and established separate payment for Behavioral Health 
Integration (BHI) services (81 FR 80226 through 80227).
    As part of this shift in medical practice, and with the 
proliferation of team-based approaches to care that are often 
facilitated by electronic medical record technology, we believe that 
making separate payment for interprofessional consultations undertaken 
for the benefit of treating a patient will contribute to payment 
accuracy for primary care and care management services. We are 
proposing separate payment for these services, discussed in section 
II.H. Valuation of Specific Codes, of this proposed rule.
    While we are proposing to make separate payment for these services 
because we believe they describe resource costs directly associated 
with seeking a consultation for the benefit of the beneficiary, we do 
have concerns about how these services can be distinguished from 
activities undertaken for the benefit of the practitioner, such as 
information shared as a professional courtesy or as continuing 
education. We do not believe that those examples would constitute a 
service directly attributable to a single Medicare beneficiary, and 
therefore neither the Medicare program nor the beneficiary should be 
responsible for those costs. We are therefore seeking comment on our 
assumption that these are separately identifiable services, and the 
extent to which they can be distinguished from similar services that 
are nonetheless primarily for the benefit of the practitioner. We note 
that there are program integrity concerns around making separate 
payment for these interprofessional consultation services, including 
around CMS' or its contractors' ability to evaluate whether an 
interprofessional consultation is reasonable and necessary under the 
particular circumstances. We are seeking comment on how best to 
minimize potential program integrity issues, and are particularly 
interested in information on whether these types of services are paid 
separately by private payers and if so, what controls or limitations 
private payers have put in place to ensure these services are billed 
appropriately.
    Additionally, since these codes describe services that are 
furnished without the beneficiary being present, we are proposing to 
require the treating practitioner to obtain verbal beneficiary consent 
in advance of these services, which would be documented by the treating 
practitioner in the medical record, similar to the conditions of 
payment associated with the care management services under the PFS. 
Obtaining advance consent includes ensuring that the patient is aware 
of applicable cost sharing. We welcome comments on this proposal.
4. Medicare Telehealth Services Under Section 1834(m) of the Act
a. Billing and Payment for Medicare Telehealth Services Under Section 
1834(m) of the Act
    As discussed in prior rulemaking, several conditions must be met 
for Medicare to make payment for telehealth services under the PFS. For 
further details, see the full discussion of the scope of Medicare 
telehealth services in the CY 2018 PFS final rule (82 FR 53006).
b. Adding Services to the List of Medicare Telehealth Services
    In the CY 2003 PFS final rule with comment period (67 FR 79988), we 
established a process for adding services to or deleting services from 
the list of Medicare telehealth services in accordance with section 
1834(m)(4)(F)(ii) of the Act. This process provides the public with an 
ongoing opportunity to submit requests for adding services, which are 
then reviewed by us. Under this process, we assign any submitted 
request to add to the list of telehealth services to one of the 
following two categories:
     Category 1: Services that are similar to professional 
consultations, office visits, and office psychiatry services that are 
currently on the list of telehealth services. In reviewing these 
requests, we look for similarities between the requested and existing 
telehealth services for the roles of, and interactions among, the 
beneficiary, the physician (or other practitioner) at the distant site 
and, if necessary, the telepresenter, a practitioner who is present 
with the beneficiary in the originating site. We also look for 
similarities in the telecommunications system used to deliver the 
service; for example, the use of interactive audio and video equipment.
     Category 2: Services that are not similar to those on the 
current list of telehealth services. Our review of these requests 
includes an assessment of whether the service is accurately described 
by the corresponding code when furnished via telehealth and whether the 
use of a telecommunications system to furnish the service produces 
demonstrated clinical benefit to the patient. Submitted evidence should 
include both a description of relevant clinical studies that 
demonstrate the service furnished by telehealth to a Medicare 
beneficiary improves the diagnosis or treatment of an illness or injury 
or improves the functioning of a malformed body part, including dates 
and findings, and a list and copies of published peer reviewed articles 
relevant to the service when furnished via telehealth. Our evidentiary 
standard of clinical benefit does not include minor or incidental 
benefits.
    Some examples of clinical benefit include the following:
     Ability to diagnose a medical condition in a patient 
population without access to clinically appropriate in-person 
diagnostic services.
     Treatment option for a patient population without access 
to clinically appropriate in-person treatment options.
     Reduced rate of complications.
     Decreased rate of subsequent diagnostic or therapeutic 
interventions (for example, due to reduced rate of recurrence of the 
disease process).
     Decreased number of future hospitalizations or physician 
visits.
     More rapid beneficial resolution of the disease process 
treatment.
     Decreased pain, bleeding, or other quantifiable symptom.
     Reduced recovery time.
    The list of telehealth services, including the proposed additions 
described below, is included in the Downloads section to this proposed 
rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    Historically, requests to add services to the list of Medicare 
telehealth services had to be submitted and received no later than 
December 31 of each calendar year to be considered for the next 
rulemaking cycle. However, for CY 2019 and onward, we intend to accept 
requests through February 10, consistent with the deadline for our 
receipt of code valuation recommendations from the RUC. To be 
considered during PFS rulemaking for CY 2020, requests to add services 
to the list of Medicare telehealth services must be submitted and 
received by February 10, 2019. Each request to add a service to the 
list of Medicare telehealth

[[Page 35727]]

services must include any supporting documentation the requester wishes 
us to consider as we review the request. Because we use the annual PFS 
rulemaking process as the vehicle to make changes to the list of 
Medicare telehealth services, requesters should be advised that any 
information submitted as part of a request is subject to public 
disclosure for this purpose. For more information on submitting a 
request to add services to the list of Medicare telehealth services, 
including where to mail these requests, see our website at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/.
c. Submitted Requests To Add Services to the List of Telehealth 
Services for CY 2019
    Under our current policy, we add services to the telehealth list on 
a Category 1 basis when we determine that they are similar to services 
on the existing telehealth list for the roles of, and interactions 
among, the beneficiary, physician (or other practitioner) at the 
distant site and, if necessary, the telepresenter. As we stated in the 
CY 2012 PFS final rule with comment period (76 FR 73098), we believe 
that the Category 1 criteria not only streamline our review process for 
publicly requested services that fall into this category, but also 
expedite our ability to identify codes for the telehealth list that 
resemble those services already on this list.
    We received several requests in CY 2017 to add various services as 
Medicare telehealth services effective for CY 2019. The following 
presents a discussion of these requests, and our proposals for 
additions to the CY 2019 telehealth list. Of the requests received, we 
found that two services were sufficiently similar to services currently 
on the telehealth list to be added on a Category 1 basis. Therefore, we 
are proposing to add the following services to the telehealth list on a 
Category 1 basis for CY 2019:
     HCPCS codes G0513 and G0514 (Prolonged preventive 
service(s) (beyond the typical service time of the primary procedure), 
in the office or other outpatient setting requiring direct patient 
contact beyond the usual service; first 30 minutes (list separately in 
addition to code for preventive service) and (Prolonged preventive 
service(s) (beyond the typical service time of the primary procedure), 
in the office or other outpatient setting requiring direct patient 
contact beyond the usual service; each additional 30 minutes (list 
separately in addition to code G0513 for additional 30 minutes of 
preventive service).
    We found that the services described by HCPCS codes G0513 and G0514 
are sufficiently similar to office visits currently on the telehealth 
list. We believe that all the components of this service can be 
furnished via interactive telecommunications technology. Additionally, 
we believe that adding these services to the telehealth list would make 
it administratively easier for practitioners who report these services 
in connection with a preventive service that is furnished via 
telehealth, as both the base code and the add-on code would be reported 
with the telehealth place of service.
    We also received requests to add services to the telehealth list 
that do not meet our criteria for Medicare telehealth services. We are 
not proposing to add to the Medicare telehealth services list the 
following procedures for chronic care remote physiologic monitoring, 
interprofessional internet consultation, and initial hospital care; or 
to change the requirements for subsequent hospital care or subsequent 
nursing facility care, for the reasons noted in the paragraphs that 
follow.
(1) Chronic Care Remote Physiologic Monitoring: CPT Codes
     CPT code 990X0 (Remote monitoring of physiologic 
parameter(s) (e.g., weight, blood pressure, pulse oximetry, respiratory 
flow rate), initial; set-up and patient education on use of equipment).
     CPT code 990X1 (Remote monitoring of physiologic 
parameter(s) (e.g., weight, blood pressure, pulse oximetry, respiratory 
flow rate), initial; device(s) supply with daily recording(s) or 
programmed alert(s) transmission, each 30 days).
     CPT code 994X9 (Remote physiologic monitoring treatment 
management services, 20 minutes or more of clinical staff/physician/
other qualified healthcare professional time in a calendar month 
requiring interactive communication with the patient/caregiver during 
the month).
    In the CY 2016 PFS final rule with comment period (80 FR 71064), we 
responded to a request to add CPT code 99490 (Chronic care management 
services, at least 20 minutes of clinical staff time directed by a 
physician or other qualified health care professional, per calendar 
month, with the following required elements: Multiple (two or more) 
chronic conditions expected to last at least 12 months, or until the 
death of the patient; chronic conditions place the patient at 
significant risk of death, acute exacerbation/decompensation, or 
functional decline; comprehensive care plan established, implemented, 
revised, or monitored) to the Medicare telehealth list. We discussed 
that the services described by CPT code 99490 can be furnished without 
the beneficiary's face-to-face presence and using any number of non-
face-to-face means of communication. We stated that it was therefore 
unnecessary to add that service to the list of Medicare telehealth 
services. Similarly, CPT codes 990X0, 990X1, and 994X9 describe 
services that are inherently non face-to-face. As discussed in section 
II.H. Valuation of Specific Codes, we instead are proposing to adopt 
CPT codes 990X0, 990X1, and 994X9 for payment under the PFS. Because 
these codes describe services that are inherently non face-to-face, we 
do not consider them Medicare telehealth services under section 1834(m) 
of the Act; therefore, we are not proposing to add them to the list of 
Medicare telehealth services.
(2) Interprofessional Internet Consultation: CPT Codes
     CPT code 994X0 (Interprofessional telephone/internet/
electronic health record referral service(s) provided by a treating/
requesting physician or qualified health care professional, 30 
minutes).
     CPT code 994X6 (Interprofessional telephone/internet/
electronic health record assessment and management service provided by 
a consultative physician including a written report to the patient's 
treating/requesting physician or other qualified health care 
professional, 5 or more minutes of medical consultative time).
    As discussed in section II.H. Valuation of Specific Codes, we are 
proposing to adopt CPT codes 994X0 and 994X6 for payment under the PFS 
as these are distinct services furnished via communication technology. 
Because these codes describe services that are inherently non face-to-
face, we do not consider them as Medicare telehealth services under 
section 1834(m) of the Act; therefore we are not proposing to add them 
to the list of Medicare telehealth services for CY 2019.
(3) Initial Hospital Care Services: CPT Codes
     CPT code 99221 (Initial hospital care, per day, for the 
evaluation and management of a patient, which requires these 3 key 
components: A detailed or comprehensive history; A detailed or 
comprehensive examination; and Medical decision making that is 
straightforward or of low complexity. Counseling and/or coordination of 
care

[[Page 35728]]

with other physicians, other qualified health care professionals, or 
agencies are provided consistent with the nature of the problem(s) and 
the patient's and/or family's needs. Usually, the problem(s) requiring 
admission are of low severity.)
     CPT code 99222 (Initial hospital care, per day, for the 
evaluation and management of a patient, which requires these 3 key 
components: A comprehensive history; A comprehensive examination; and 
Medical decision making of moderate complexity. Counseling and/or 
coordination of care with other physicians, other qualified health care 
professionals, or agencies are provided consistent with the nature of 
the problem(s) and the patient's and/or family's needs. Usually, the 
problem(s) requiring admission are of moderate severity.)
     CPT code 99223 (Initial hospital care, per day, for the 
evaluation and management of a patient, which requires these 3 key 
components: A comprehensive history; A comprehensive examination; and 
Medical decision making of high complexity. Counseling and/or 
coordination of care with other physicians, other qualified health care 
professionals, or agencies are provided consistent with the nature of 
the problem(s) and the patient's and/or family's needs. Usually, the 
problem(s) requiring admission are of high severity.)
    We have previously considered requests to add these codes to the 
telehealth list. As we stated in the CY 2011 PFS final rule with 
comment period (75 FR 73315), while initial inpatient consultation 
services are currently on the list of approved telehealth services, 
there are no services on the current list of telehealth services that 
resemble initial hospital care for an acutely ill patient by the 
admitting practitioner who has ongoing responsibility for the patient's 
treatment during the course of the hospital stay. Therefore, consistent 
with prior rulemaking, we do not propose that initial hospital care 
services be added to the Medicare telehealth services list on a 
category 1 basis.
    The initial hospital care codes describe the first visit of the 
hospitalized patient by the admitting practitioner who may or may not 
have seen the patient in the decision-making phase regarding 
hospitalization. Based on the description of the services for these 
codes, we believed it is critical that the initial hospital visit by 
the admitting practitioner be conducted in person to ensure that the 
practitioner with ongoing treatment responsibility comprehensively 
assesses the patient's condition upon admission to the hospital through 
a thorough in-person examination. Additionally, the requester submitted 
no additional research or evidence that the use of a telecommunications 
system to furnish the service produces demonstrated clinical benefit to 
the patient; therefore, we also do not propose adding initial hospital 
care services to the Medicare telehealth services list on a Category 2 
basis.
    We note that Medicare beneficiaries who are being treated in the 
hospital setting can receive reasonable and necessary E/M services 
using other HCPCS codes that are currently on the Medicare telehealth 
list, including those for subsequent hospital care, initial and follow-
up telehealth inpatient and emergency department consultations, as well 
as initial and follow-up critical care telehealth consultations.
    Therefore, we are not proposing to add the initial hospital care 
services to the list of Medicare telehealth services for CY 2019.
(4) Subsequent Hospital Care Services: CPT Codes
     CPT code 99231 (Subsequent hospital care, per day, for the 
evaluation and management of a patient, which requires at least 2 of 
these 3 key components: A problem focused interval history; A problem 
focused examination; Medical decision making that is straightforward or 
of low complexity. Counseling and/or coordination of care with other 
physicians, other qualified health care professionals, or agencies are 
provided consistent with the nature of the problem(s) and the patient's 
and/or family's needs. Usually, the patient is stable, recovering or 
improving. Typically, 15 minutes are spent at the bedside and on the 
patient's hospital floor or unit.)
     CPT code 99232 (Subsequent hospital care, per day, for the 
evaluation and management of a patient, which requires at least 2 of 
these 3 key components: An expanded problem focused interval history; 
an expanded problem focused examination; medical decision making of 
moderate complexity. Counseling and/or coordination of care with other 
physicians, other qualified health care professionals, or agencies are 
provided consistent with the nature of the problem(s) and the patient's 
and/or family's needs. Usually, the patient is responding inadequately 
to therapy or has developed a minor complication. Typically, 25 minutes 
are spent at the bedside and on the patient's hospital floor or unit.)
     CPT code 99233 (Subsequent hospital care, per day, for the 
evaluation and management of a patient, which requires at least 2 of 
these 3 key components: A detailed interval history; a detailed 
examination; Medical decision making of high complexity. Counseling 
and/or coordination of care with other physicians, other qualified 
health care professionals, or agencies are provided consistent with the 
nature of the problem(s) and the patient's and/or family's needs. 
Usually, the patient is unstable or has developed a significant 
complication or a significant new problem. Typically, 35 minutes are 
spent at the bedside and on the patient's hospital floor or unit.)
    CPT codes 99231-99233 are currently on the list of Medicare 
telehealth services, but can only be billed via telehealth once every 3 
days. The requester asked that we remove the frequency limitation. We 
stated in the CY 2011 PFS final rule with comment period (75 FR 73316) 
that, while we still believed the potential acuity of hospital 
inpatients is greater than those patients likely to receive Medicare 
telehealth services that were on the list at that time, we also 
believed that it would be appropriate to permit some subsequent 
hospital care services to be furnished through telehealth in order to 
ensure that hospitalized patients have frequent encounters with their 
admitting practitioner. We also noted that we continue to believe that 
the majority of these visits should be in-person to facilitate the 
comprehensive, coordinated, and personal care that medically volatile, 
acutely ill patients require on an ongoing basis. Because of our 
concerns regarding the potential acuity of hospital inpatients, we 
finalized the addition of CPT codes 99231-99233 to the list of Medicare 
telehealth services, but limited the provision of these subsequent 
hospital care services through telehealth to once every 3 days. We 
continue to believe that admitting practitioners should continue to 
make appropriate in-person visits to all patients who need such care 
during their hospitalization. Our concerns and position on the 
provision of subsequent hospital care services via telehealth have not 
changed. Therefore, we are not proposing to remove the frequency 
limitation on these codes.
(5) Subsequent Nursing Facility Care Services: CPT Codes
     CPT code 99307 (Subsequent nursing facility care, per day, 
for the evaluation and management of a patient, which requires at least 
2 of these 3 key

[[Page 35729]]

components: A problem focused interval history; A problem focused 
examination; Straightforward medical decision making. Counseling and/or 
coordination of care with other physicians, other qualified health care 
professionals, or agencies are provided consistent with the nature of 
the problem(s) and the patient's and/or family's needs. Usually, the 
patient is stable, recovering, or improving. Typically, 10 minutes are 
spent at the bedside and on the patient's facility floor or unit.)
     CPT code 99308 (Subsequent nursing facility care, per day, 
for the evaluation and management of a patient, which requires at least 
2 of these 3 key components: An expanded problem focused interval 
history; an expanded problem focused examination; Medical decision 
making of low complexity. Counseling and/or coordination of care with 
other physicians, other qualified health care professionals, or 
agencies are provided consistent with the nature of the problem(s) and 
the patient's and/or family's needs. Usually, the patient is responding 
inadequately to therapy or has developed a minor complication. 
Typically, 15 minutes are spent at the bedside and on the patient's 
facility floor or unit.)
     CPT code 99309 (Subsequent nursing facility care, per day, 
for the evaluation and management of a patient, which requires at least 
2 of these 3 key components: A detailed interval history; a detailed 
examination; Medical decision making of moderate complexity. Counseling 
and/or coordination of care with other physicians, other qualified 
health care professionals, or agencies are provided consistent with the 
nature of the problem(s) and the patient's and/or family's needs. 
Usually, the patient has developed a significant complication or a 
significant new problem. Typically, 25 minutes are spent at the bedside 
and on the patient's facility floor or unit.)
     CPT code 99310 (Subsequent nursing facility care, per day, 
for the evaluation and management of a patient, which requires at least 
2 of these 3 key components: A comprehensive interval history; a 
comprehensive examination; Medical decision making of high complexity. 
Counseling and/or coordination of care with other physicians, other 
qualified health care professionals, or agencies are provided 
consistent with the nature of the problem(s) and the patient's and/or 
family's needs. The patient may be unstable or may have developed a 
significant new problem requiring immediate physician attention. 
Typically, 35 minutes are spent at the bedside and on the patient's 
facility floor or unit.)
    CPT codes 99307-99310 are currently on the list of Medicare 
telehealth services, but can only be billed via telehealth once every 
30 days. The requester asked that we remove the frequency limitation 
when these services are provided for psychiatric care. We stated in the 
CY 2011 PFS final rule with comment period (75 FR 73317) that we 
believed it would be appropriate to permit some subsequent nursing 
facility care services to be furnished through telehealth to ensure 
that complex nursing facility patients have frequent encounters with 
their admitting practitioner, but because of our concerns regarding the 
potential acuity and complexity of SNF inpatients, we limited the 
provision of subsequent nursing facility care services furnished 
through telehealth to once every 30 days. Since these codes are used to 
report care for patients with a variety of diagnoses, including 
psychiatric diagnoses, we do not think it would be appropriate to 
remove the frequency limitation only for certain diagnoses. The 
services described by these CPT codes are essentially the same service, 
regardless of the patient's diagnosis. We also continue to have 
concerns regarding the potential acuity and complexity of SNF 
inpatients, and therefore, we are not proposing to remove the frequency 
limitation for subsequent nursing facility care services in CY 2019.
    In summary, we are proposing to add the following codes to the list 
of Medicare telehealth services beginning in CY 2019 on a category 1 
basis:
     HCPCS code G0513 (Prolonged preventive service(s) (beyond 
the typical service time of the primary procedure), in the office or 
other outpatient setting requiring direct patient contact beyond the 
usual service; first 30 minutes (list separately in addition to code 
for preventive service).
     HCPCS code G0514 (Prolonged preventive service(s) (beyond 
the typical service time of the primary procedure), in the office or 
other outpatient setting requiring direct patient contact beyond the 
usual service; each additional 30 minutes (list separately in addition 
to code G0513 for additional 30 minutes of preventive service).
5. Expanding the Use of Telehealth Under the Bipartisan Budget Act of 
2018
a. Expanding Access to Home Dialysis Therapy Under the Bipartisan 
Budget Act of 2018
    Section 50302 of the BBA of 2018 amended sections 1881(b)(3) and 
1834(m) of the Act to allow an individual determined to have end-stage 
renal disease receiving home dialysis to choose to receive certain 
monthly end-stage renal disease-related (ESRD-related) clinical 
assessments via telehealth on or after January 1, 2019. The new section 
1881(b)(3)(B)(ii) of the Act requires that such an individual must 
receive a face-to-face visit, without the use of telehealth, at least 
monthly in the case of the initial 3 months of home dialysis and at 
least once every 3 consecutive months after the initial 3 months.
    As added by section 50302(b)(1) of the BBA of 2018, subclauses (IX) 
and (X) of section 1834(m)(4)(C)(ii) of the Act include a renal 
dialysis facility and the home of an individual as telehealth 
originating sites but only for the purposes of the monthly ESRD-related 
clinical assessments furnished through telehealth provided under 
section 1881(b)(3)(B) of the Act. Section 50302(b)(1) also added a new 
section 1834(m)(5) of the Act which provides that the geographic 
requirements for telehealth services under section 1834(m)(4)(C)(i) of 
the Act do not apply to telehealth services furnished on or after 
January 1, 2019 for purposes of the monthly ESRD-related clinical 
assessments where the originating site is a hospital-based or critical 
access hospital-based renal dialysis center, a renal dialysis facility, 
or the home of an individual. Section 50302(b)(2) of the BBA of 2018 
amended section 1834(m)(2)(B)(ii) of the Act to require that no 
originating site facility fee is to be paid if the home of the 
individual is the originating site.
    Our current regulation at Sec.  410.78 specifies the conditions 
that must be met in order for Medicare Part B to pay for covered 
telehealth services included on the telehealth list when furnished by 
an interactive telecommunications system. In accordance with the new 
subclauses (IX) and (X) of section 1834(m)(4)(C)(ii) of the Act, we are 
proposing to revise our regulation at Sec.  410.78(b)(3) to add a renal 
dialysis facility and the home of an individual as Medicare telehealth 
originating sites, but only for purposes of the home dialysis monthly 
ESRD-related clinical assessment in section 1881(b)(3)(B) of the Act. 
We propose to amend Sec.  414.65(b)(3) to reflect the requirement in 
section 1834(m)(2)(B)(ii) of the Act that there is no originating site 
facility fee paid when the originating site for these services is the 
patient's home. Additionally, we are proposing to add new Sec.  
410.78(b)(4)(iv)(A), to reflect the provision in section 1834(m)(5) of 
the Act, added by section 50302 of the BBA

[[Page 35730]]

of 2018, specifying that the geographic requirements described in 
section 1834(m)(4)(C)(i) of the Act do not apply with respect to 
telehealth services furnished on or after January 1, 2019, in 
originating sites that are hospital-based or critical access hospital-
based renal dialysis centers, renal dialysis facilities, or the 
patient's home, respectively under sections 1834(m)(4)(C)(ii)(VI), (IX) 
and (X) of the Act, for purposes of section 1881(b)(3)(B) of the Act.
b. Expanding the Use of Telehealth for Individuals With Stroke Under 
the Bipartisan Budget Act of 2018
    Section 50325 of the BBA of 2018 amended section 1834(m) of the Act 
by adding a new paragraph (6) that provides special rules for 
telehealth services furnished on or after January 1, 2019, for purposes 
of diagnosis, evaluation, or treatment of symptoms of an acute stroke 
(acute stroke telehealth services), as determined by the Secretary. 
Specifically, section 1834(m)(6)(A) of the Act removes the restrictions 
on the geographic locations and the types of originating sites where 
acute stroke telehealth services can be furnished. Section 
1834(m)(6)(B) of the Act specifies that acute stroke telehealth 
services can be furnished in any hospital, critical access hospital, 
mobile stroke units (as defined by the Secretary), or any other site 
determined appropriate by the Secretary, in addition to the current 
eligible telehealth originating sites. Section 1834(m)(6)(C) of the Act 
limits payment of an originating site facility fee to acute stroke 
telehealth services furnished in sites that meet the usual telehealth 
restrictions under section 1834(m)(4)(C) of the Act.
    To implement these requirements, we are proposing to create a new 
modifier that would be used to identify acute stroke telehealth 
services. The practitioner and, as appropriate, the originating site, 
would append this modifier when clinically appropriate to the HCPCS 
code when billing for an acute stroke telehealth service or an 
originating site facility fee, respectively. We note that section 50325 
of the BBA of 2018 did not amend section 1834(m)(4)(F) of the Act, 
which limits the scope of telehealth services to those on the Medicare 
telehealth list. Practitioners would be responsible for assessing 
whether it would be clinically appropriate to use this modifier with 
codes from the Medicare telehealth list. By billing with this modifier, 
practitioners would be indicating that the codes billed were used to 
furnish telehealth services for diagnosis, evaluation, or treatment of 
symptoms of an acute stroke. We believe that the adoption of a service 
level modifier is the least administratively burdensome means of 
implementing this provision for practitioners, while also allowing CMS 
to easily track and analyze utilization of these services.
    In accordance with section 1834(m)(6)(B) of the Act, as added by 
section 50325 of the BBA of 2018, we are also proposing to revise Sec.  
410.78(b)(3) of our regulations to add mobile stroke unit as a 
permissible originating site for acute stroke telehealth services. We 
are proposing to define a mobile stroke unit as a mobile unit that 
furnishes services to diagnose, evaluate, and/or treat symptoms of an 
acute stroke and are seeking comment on this definition, as well as 
additional information on how these units are used in current medical 
practice. We are therefore proposing that mobile stroke units and the 
current eligible telehealth originating sites, which include hospitals 
and critical access hospitals as specified in section 1834(m)(6)(B) of 
the Act, but excluding renal dialysis facilities and patient homes 
because they are only allowable originating sites for purposes of home 
dialysis monthly ESRD-related clinical assessments in section 
1881(b)(3)(B) of the Act, would be permissible originating sites for 
acute stroke telehealth services.
    We also seek comment on other possible appropriate originating 
sites for telehealth services furnished for the diagnosis, evaluation, 
or treatment of symptoms of an acute stroke. Any additional sites would 
be adopted through future rulemaking. As required under section 
1834(m)(6)(C) of the Act, the originating site facility fee would not 
apply in instances where the originating site does not meet the 
originating site type and geographic requirements under section 
1834(m)(4)(C) of the Act. Additionally, we are proposing to add Sec.  
410.78(b)(4)(iv)(B) to specify that the requirements in section 
1834(m)(4)(C) of the Act do not apply with respect to telehealth 
services furnished on or after January 1, 2019, for purposes of 
diagnosis, evaluation, or treatment of symptoms of an acute stroke.
6. Modifying Sec.  414.65 Regarding List of Telehealth Services
    In the CY 2015 PFS final rule with comment period, we finalized a 
proposal to change our regulation at Sec.  410.78(b) by deleting the 
description of the individual services for which Medicare payment can 
be made when furnished via telehealth, noting that we revised Sec.  
410.78(f) to indicate that a list of Medicare telehealth codes and 
descriptors is available on the CMS website (79 FR 67602). In 
accordance with that change, we are proposing a technical revision to 
also delete the description of individual services and exceptions for 
Medicare payment for telehealth services in Sec.  414.65, by amending 
Sec.  414.65(a) to note that Medicare payment for telehealth services 
is addressed in Sec.  410.78 and by deleting Sec.  414.65(a)(1).
7. Comment Solicitation on Creating a Bundled Episode of Care for 
Management and Counseling Treatment for Substance Use Disorders
    There is an evidence base that suggests that routine counseling, 
either associated with medication assisted treatment (MAT) or on its 
own, can increase the effectiveness of treatment for substance use 
disorders (SUDs). According to a study in the Journal of Substance 
Abuse Treatment,\1\ patients treated with a combination of web-based 
counseling as part of a substance abuse treatment program demonstrated 
increased treatment adherence and satisfaction. The federal guidelines 
for opioid treatment programs describe that MAT and wrap-around 
psychosocial and support services can include the following services: 
Physical exam and assessment; psychosocial assessment; treatment 
planning; counseling; medication management; drug administration; 
comprehensive care management and supportive services; care 
coordination; management of care transitions; individual and family 
support services; and health promotion (https://store.samhsa.gov/shin/content/PEP15-FEDGUIDEOTP/PEP15-FEDGUIDEOTP.pdf). Creating separate 
payment for a bundled episode of care for components of MAT such as 
management and counseling treatment for substance use disorders (SUD), 
including opioid use disorder, treatment planning, and medication 
management or observing drug dosing for treatment of SUDs under the PFS 
could provide opportunities to better leverage services furnished with 
communication technology while expanding access to treatment for SUDs.
---------------------------------------------------------------------------

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

    We also believe making separate payment for a bundled episode of 
care for management and counseling for SUDs could be effective in 
preventing the need for more acute services. For example, according to 
the Healthcare

[[Page 35731]]

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

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

    As indicated above, we are considering whether it would be 
appropriate to develop a separate bundled payment for an episode of 
care for treatment of SUDs. We are seeking public comment on whether 
such a bundled episode-based payment would be beneficial to improve 
access, quality and efficiency for SUD treatment. Further, we are 
seeking public comment on developing coding and payment for a bundled 
episode of care for treatment for SUDs that could include overall 
treatment management, any necessary counseling, and components of a MAT 
program such as treatment planning, medication management, and 
observation of drug dosing. Specifically, we are seeking public 
comments related to what assumptions we might make about the typical 
number of counseling sessions as well as the duration of the service 
period, which types of practitioners could furnish these services, and 
what components of MAT could be included in the bundled episode of 
care. We are interested in stakeholder feedback regarding how to define 
and value this bundle and what conditions of payment should be 
attached. Additionally, we are seeking comment on whether the concept 
of a global period, similar to the currently existing global periods 
for surgical procedures, might be applicable to treatment for SUDs.
    We also seek comment on whether the counseling portion and other 
MAT components could also be provided by qualified practitioners 
``incident to'' the services of the billing physician who would 
administer or prescribe any necessary medications and manage the 
overall care, as well as supervise any other counselors participating 
in the treatment, similar to the structure of the Behavioral Health 
Integration codes which include services provided by other members of 
the care team under the direction of the billing practitioner on an 
``incident to'' basis (81 FR 80231). We welcome comments on potentially 
creating a bundled episode of care for management and counseling 
treatment for SUDs, which we will consider for future rulemaking.
    Additionally, we invite public comment and suggestions for 
regulatory and subregulatory changes to help prevent opioid use 
disorder and improve access to treatment under the Medicare program. We 
seek comment on methods for identifying non-opioid alternatives for 
pain treatment and management, along with identifying barriers that may 
inhibit access to these non-opioid alternatives including barriers 
related to payment or coverage. Consistent with our ``Patients Over 
Paperwork'' Initiative, we are interested in suggestions to improve 
existing requirements in order to more effectively address the opioid 
epidemic.

E. Potentially Misvalued Services Under the PFS

1. Background
    Section 1848(c)(2)(B) of the Act directs the Secretary to conduct a 
periodic review, not less often than every 5 years, of the RVUs 
established under the PFS. Section 1848(c)(2)(K) of the Act requires 
the Secretary to periodically identify potentially misvalued services 
using certain criteria and to review and make appropriate adjustments 
to the relative values for those services. Section 1848(c)(2)(L) of the 
Act also requires the Secretary to develop a process to validate the 
RVUs of certain potentially misvalued codes under the PFS, using the 
same criteria used to identify potentially misvalued codes, and to make 
appropriate adjustments.
    As discussed in section II.H. of this proposed rule, each year we 
develop appropriate adjustments to the RVUs taking into account 
recommendations provided by the RUC, MedPAC, and other stakeholders. 
For many years, the RUC has provided us with recommendations on the 
appropriate relative values for new, revised, and potentially misvalued 
PFS services. We review these recommendations on a code-by-code basis 
and consider these recommendations in conjunction with analyses of 
other data, such as claims data, to inform the decision-making process 
as authorized by law. We may also consider analyses of work time, work 
RVUs, or direct PE inputs using other data sources, such as Department 
of Veteran Affairs (VA), National Surgical Quality Improvement Program 
(NSQIP), the Society for Thoracic Surgeons (STS), and the Physician 
Quality Reporting System (PQRS) databases. In addition to considering 
the most recently available data, we assess the results of physician 
surveys and specialty recommendations submitted to us by the RUC for 
our review. We also consider information provided by other 
stakeholders. We conduct a review to assess the appropriate RVUs in the 
context of contemporary medical practice. We note that section 
1848(c)(2)(A)(ii) of the Act authorizes the use of extrapolation and 
other techniques to determine the RVUs for physicians' services for 
which specific data are not available and requires us to take into 
account the results of consultations with organizations representing 
physicians who provide the services. In accordance with section 1848(c) 
of the Act, we determine and make appropriate adjustments to the RVUs.
    In its March 2006 Report to the Congress (https://www.medpac.gov/docs/default-source/congressional-testimony/testimony-report-to-the-congress-medicare-payment-policy-march-2006-.pdf?sfvrsn=0), MedPAC 
discussed the importance of appropriately valuing physicians' services, 
noting that misvalued services can distort the market for physicians' 
services, as well as for other health care services that physicians 
order, such as hospital services. In that same report, MedPAC 
postulated that physicians' services under the PFS can become misvalued 
over time. MedPAC stated, ``When a new service is added to the 
physician fee schedule, it may be assigned a relatively high value 
because of the time, technical skill, and psychological stress that are 
often required to furnish that service. Over time, the work required 
for certain services would be expected to decline as physicians become 
more familiar with the service and more efficient in furnishing it.'' 
We believe services can also become overvalued when PE declines. This 
can happen when the costs of equipment and supplies fall, or when 
equipment is used more frequently than is estimated in the PE 
methodology, reducing its cost per use. Likewise, services can become 
undervalued when physician work increases or PE rises.
    As MedPAC noted in its March 2009 Report to Congress (https://www.medpac.gov/docs/default-source/reports/march-2009-report-to-congress-medicare-payment-policy.pdf), in the intervening years since 
MedPAC made the initial recommendations, CMS and the RUC have taken 
several steps to

[[Page 35732]]

improve the review process. Also, section 1848(c)(2)(K)(ii) of the Act 
augments our efforts by directing the Secretary to specifically 
examine, as determined appropriate, potentially misvalued services in 
the following categories:
     Codes that have experienced the fastest growth.
     Codes that have experienced substantial changes in PE.
     Codes that describe new technologies or services within an 
appropriate time period (such as 3 years) after the relative values are 
initially established for such codes.
     Codes which are multiple codes that are frequently billed 
in conjunction with furnishing a single service.
     Codes with low relative values, particularly those that 
are often billed multiple times for a single treatment.
     Codes that have not been subject to review since 
implementation of the fee schedule.
     Codes that account for the majority of spending under the 
PFS.
     Codes for services that have experienced a substantial 
change in the hospital length of stay or procedure time.
     Codes for which there may be a change in the typical site 
of service since the code was last valued.
     Codes for which there is a significant difference in 
payment for the same service between different sites of service.
     Codes for which there may be anomalies in relative values 
within a family of codes.
     Codes for services where there may be efficiencies when a 
service is furnished at the same time as other services.
     Codes with high intraservice work per unit of time.
     Codes with high PE RVUs.
     Codes with high cost supplies.
     Codes as determined appropriate by the Secretary.
    Section 1848(c)(2)(K)(iii) of the Act also specifies that the 
Secretary may use existing processes to receive recommendations on the 
review and appropriate adjustment of potentially misvalued services. In 
addition, the Secretary may conduct surveys, other data collection 
activities, studies, or other analyses, as the Secretary determines to 
be appropriate, to facilitate the review and appropriate adjustment of 
potentially misvalued services. This section also authorizes the use of 
analytic contractors to identify and analyze potentially misvalued 
codes, conduct surveys or collect data, and make recommendations on the 
review and appropriate adjustment of potentially misvalued services. 
Additionally, this section provides that the Secretary may coordinate 
the review and adjustment of any RVU with the periodic review described 
in section 1848(c)(2)(B) of the Act. Section 1848(c)(2)(K)(iii)(V) of 
the Act specifies that the Secretary may make appropriate coding 
revisions (including using existing processes for consideration of 
coding changes) that may include consolidation of individual services 
into bundled codes for payment under the PFS.
2. Progress in Identifying and Reviewing Potentially Misvalued Codes
    To fulfill our statutory mandate, we have identified and reviewed 
numerous potentially misvalued codes as specified in section 
1848(c)(2)(K)(ii) of the Act, and we intend to continue our work 
examining potentially misvalued codes in these areas over the upcoming 
years. As part of our current process, we identify potentially 
misvalued codes for review, and request recommendations from the RUC 
and other public commenters on revised work RVUs and direct PE inputs 
for those codes. The RUC, through its own processes, also identifies 
potentially misvalued codes for review. Through our public nomination 
process for potentially misvalued codes established in the CY 2012 PFS 
final rule with comment period, other individuals and stakeholder 
groups submit nominations for review of potentially misvalued codes as 
well.
    Since CY 2009, as a part of the annual potentially misvalued code 
review and Five-Year Review process, we have reviewed approximately 
1,700 potentially misvalued codes to refine work RVUs and direct PE 
inputs. We have assigned appropriate work RVUs and direct PE inputs for 
these services as a result of these reviews. A more detailed discussion 
of the extensive prior reviews of potentially misvalued codes is 
included in the CY 2012 PFS final rule with comment period (76 FR 73052 
through 73055). In the CY 2012 PFS final rule with comment period (76 
FR 73055 through 73958), we finalized our policy to consolidate the 
review of physician work and PE at the same time, and established a 
process for the annual public nomination of potentially misvalued 
services.
    In the CY 2013 PFS final rule with comment period, we built upon 
the work we began in CY 2009 to review potentially misvalued codes that 
have not been reviewed since the implementation of the PFS (so-called 
``Harvard-valued codes''). In CY 2009 (73 FR 38589), we requested 
recommendations from the RUC to aid in our review of Harvard-valued 
codes that had not yet been reviewed, focusing first on high-volume, 
low intensity codes. In the fourth Five-Year Review (76 FR 32410), we 
requested recommendations from the RUC to aid in our review of Harvard-
valued codes with annual utilization of greater than 30,000 services. 
In the CY 2013 PFS final rule with comment period, we identified 
specific Harvard-valued services with annual allowed charges that total 
at least $10,000,000 as potentially misvalued. In addition to the 
Harvard-valued codes, in the CY 2013 PFS final rule with comment period 
we finalized for review a list of potentially misvalued codes that have 
stand-alone PE (codes with physician work and no listed work time and 
codes with no physician work that have listed work time).
    In the CY 2016 PFS final rule with comment period, we finalized for 
review a list of potentially misvalued services, which included eight 
codes in the neurostimulators analysis-programming family (CPT codes 
95970-95982). We also finalized as potentially misvalued 103 codes 
identified through our screen of high expenditure services across 
specialties.
    In the CY 2017 PFS final rule, we finalized for review a list of 
potentially misvalued services, which included eight codes in the end-
stage renal disease home dialysis family (CPT codes 90963-90970). We 
also finalized as potentially misvalued 19 codes identified through our 
screen for 0-day global services that are typically billed with an 
evaluation and management (E/M) service with modifier 25.
    In the CY 2018 PFS final rule, we finalized arthrodesis of 
sacroiliac joint (CPT code 27279) as potentially misvalued. Through the 
use of comment solicitations with regard to specific codes, we also 
examined the valuations of other services, in addition to, new 
potentially misvalued code screens (82 FR 53017 through 53018).
3. CY 2019 Identification and Review of Potentially Misvalued Services
    In the CY 2012 PFS final rule with comment period (76 FR 73058), we 
finalized a process for the public to nominate potentially misvalued 
codes. The public and stakeholders may nominate potentially misvalued 
codes for review by submitting the code with supporting documentation 
by February 10 of each year. Supporting documentation for codes 
nominated for the annual review of potentially misvalued codes may 
include the following:

[[Page 35733]]

     Documentation in peer reviewed medical literature or other 
reliable data that there have been changes in physician work due to one 
or more of the following: Technique, knowledge and technology, patient 
population, site-of-service, length of hospital stay, and work time.
     An anomalous relationship between the code being proposed 
for review and other codes.
     Evidence that technology has changed physician work.
     Analysis of other data on time and effort measures, such 
as operating room logs or national and other representative databases.
     Evidence that incorrect assumptions were made in the 
previous valuation of the service, such as a misleading vignette, 
survey, or flawed crosswalk assumptions in a previous evaluation.
     Prices for certain high cost supplies or other direct PE 
inputs that are used to determine PE RVUs are inaccurate and do not 
reflect current information.
     Analyses of work time, work RVU, or direct PE inputs using 
other data sources (for example, VA, NSQIP, the STS National Database, 
and the PQRS databases).
     National surveys of work time and intensity from 
professional and management societies and organizations, such as 
hospital associations.
    We evaluate the supporting documentation submitted with the 
nominated codes and assess whether the nominated codes appear to be 
potentially misvalued codes appropriate for review under the annual 
process. In the following year's PFS proposed rule, we publish the list 
of nominated codes and indicate whether we proposed each nominated code 
as a potentially misvalued code. The public has the opportunity to 
comment on these and all other proposed potentially misvalued codes. In 
that year's final rule, we finalize our list of potentially misvalued 
codes.
a. Public Nominations
    We received one submission that nominated several high-volume codes 
for review under the potentially misvalued code initiative. In their 
request, the submitter noted a systemic overvaluation of work RVUs in 
certain procedures and tests based ``on a number of Government 
Accountability Office (GAO) and the Medicare Payment Advisory 
Commission (MedPAC) reports, media reports regarding time inflation of 
specific services, and the January 19, 2017 Urban Institute report for 
CMS.'' The submitter suggested that the times CMS assumes in estimating 
work RVUs are inaccurate for procedures, especially due to substantial 
overestimates of preservice and postservice time, including follow-up 
inpatient and outpatient visits that do not take place. According to 
the submitter, the time estimates for tests and some other procedures 
are primarily overstated as part of the intraservice time. Furthermore, 
the submitter stated that previous RUC reviews of these services did 
not result in reductions in valuation that adequately reflected 
reductions in surveyed times.
    Based on these analyses, the submitter requested that the codes 
listed in Table 8 be prioritized for reviewed under the potentially 
misvalued code initiative.

            Table 8--Public Nominations Due to Overvaluation
------------------------------------------------------------------------
               CPT code                        Short description
------------------------------------------------------------------------
27130................................  Total hip arthroplasty.
27447................................  Total knee arthroplasty.
43239................................  Egd biopsy single/multiple.
45385................................  Colonoscopy w/lesion removal.
70450................................  CT head w/o contrast.
93000................................  Electrocardiogram complete.
93306................................  Tte w/doppler complete.
------------------------------------------------------------------------

    Another commenter requested that CPT codes 92992 (Atrial septectomy 
or septostomy; transvenous method, balloon (e.g., Rashkind type) 
(includes cardiac catheterization)) and 92993 (Atrial septectomy or 
septostomy; blade method (Park septostomy) (includes cardiac 
catheterization)) be reviewed under the potentially misvalued code 
initiative in order to establish national RVU values for these services 
under the MPFS. These codes are currently priced by the Medicare 
Administrative Contractors (MACs).
b. Update on the Global Surgery Data Collection
    CMS currently bundles payment for postoperative care within 10 or 
90 days after many surgical procedures. Historically, we have not 
collected data on how many postoperative visits are actually performed 
during the global period. Section 523 of the MACRA added a new 
paragraph 1848(c)(8) to the Act, and section 1848(c)(8)(B) required CMS 
to use notice and comment rulemaking to implement a process to collect 
data on the number and level of postoperative visits and use these data 
to assess the accuracy of global surgical package valuation. In the CY 
2017 PFS final rule, we adopted a policy to collect postoperative visit 
data.
    Beginning July 1, 2017, CMS required practitioners in groups with 
10 or more practitioners in nine states (Florida, Kentucky, Louisiana, 
Nevada, New Jersey, North Dakota, Ohio, Oregon, and Rhode Island) to 
use the no-pay CPT code 99024 (Postoperative follow-up visit, normally 
included in the surgical package, to indicate that an E/M service was 
performed during a postoperative period for a reason(s) related to the 
original procedure) to report postoperative visits. Practitioners who 
only practice in practices with fewer than 10 practitioners are 
exempted from required reporting, but are encouraged to report if 
feasible. The 293 procedures for which reporting is required are those 
furnished by more than 100 practitioners, and either are nationally 
furnished more than 10,000 times annually or have more than $10 million 
in annual allowed charges. A list of the procedures for which reporting 
is required is updated annually to reflect any coding changes and is 
posted on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Global-Surgery-Data-Collection-.html.
    In these nine states, from July 1, 2017 through December 31, 2017, 
there were 990,581 postoperative visits reported using CPT code 99024. 
Of the 32,573 practitioners who furnished at least one of the 293 
procedures during this period and who, based on Tax Identification 
Numbers in claims data, were likely to meet the practice size 
threshold, only 45 percent reported one or more visit using CPT code 
99024 during this 6-month period. The share of practitioners who 
reported any CPT code 99024 claims varied by specialty. Among surgical 
oncology, hand surgery, and orthopedic surgeons, reporting rates were 
92, 90, and 87 percent, respectively. In contrast, the reporting rate 
for emergency medicine physicians was 4 percent. (See Table 9.)

[[Page 35734]]



              Table 9--Share of Practitioners Who Reported Any CPT Code 99024 Claims, by Specialty
----------------------------------------------------------------------------------------------------------------
                                                                                  Number of
                  Practitioner specialty                        Number of         reporting          Percent
                                                             practitioners *  practitioners **      reporting
----------------------------------------------------------------------------------------------------------------
ALL.......................................................            32,642            14,627                45
Family practice...........................................             3,912               707                18
Emergency medicine........................................             3,612               153                 4
Physician Assistant.......................................             2,751               758                28
Orthopedic surgery........................................             2,725             2,360                87
General surgery...........................................             2,317             1,879                81
Nurse Practitioner........................................             2,217               438                20
Internal medicine.........................................             1,476               161                11
Ophthalmology.............................................             1,319             1,069                81
Urology...................................................             1,186             1,014                85
Dermatology...............................................             1,025               698                68
Diagnostic radiology......................................               982                34                 3
Obstetrics/gynecology.....................................               966               612                63
Otolaryngology............................................               872               652                75
Podiatry..................................................               761               502                66
Neurosurgery..............................................               614               512                83
Cardiology................................................               574               307                53
Neurology.................................................               525                19                 4
Vascular surgery..........................................               405               342                84
Pathologic anatomy, clinical pathology....................               355               281                79
Thoracic surgery..........................................               320               270                84
Gastroenterology..........................................               315                 6                 2
Plastic and reconstructive surgery........................               303               250                83
Physical medicine and rehabilitation......................               275                63                23
Anesthesiology............................................               254                73                29
Optometry.................................................               247               158                64
Pain Management...........................................               247                98                40
Colorectal surgery........................................               225               189                84
Hand surgery..............................................               214               193                90
Interventional radiology..................................               201                19                 9
Interventional Cardiology.................................               195               114                58
Cardiac surgery...........................................               176               148                84
Interventional Pain Management............................               165                55                33
Surgical oncology.........................................               154               141                92
Gynecologist/oncologist...................................               143               121                85
General practice..........................................               115                37                32
Peripheral vascular disease, medical or surgical..........               106                84                79
Nephrology................................................                74                 9                12
Critical care.............................................                54                34                63
Pediatric medicine........................................                39                 4                10
Infectious disease........................................                34                 3                 9
Maxillofacial surgery.....................................                25                18                72
Oral surgery..............................................                20                11                55
Osteopathic manipulative therapy..........................                18                 6                33
Hematology/oncology.......................................                16                 5                31
Geriatric medicine........................................                15                 2                13
Certified clinical nurse specialist.......................                12                 1                 8
Unknown physician specialty...............................                12                 9                75
----------------------------------------------------------------------------------------------------------------
* Limited to practitioners who performed at least one of the 293 relevant global procedures and were affiliated
  with a tax identification number with 10 or more practitioners.
** Practitioners who submitted one or more CPT code 99024 claims between July 1st, 2017 and December 31st, 2017.

    The share of practitioners who reported CPT code 99024 on any 
claims also varied by state as shown in Table 10.

Table 10--Share of Practitioners Who Reported Any CPT Code 99024 Claims,
                                by State
------------------------------------------------------------------------
                                                          Percentage of
                         State                           practitioners *
                                                          reporting **
------------------------------------------------------------------------
ALL...................................................                45
North Dakota..........................................                56
Ohio..................................................                49
Rhode Island..........................................                49
Florida...............................................                48
New Jersey............................................                43
Louisiana.............................................                42
Kentucky..............................................                41
Oregon................................................                35
Nevada................................................                30
------------------------------------------------------------------------
* Limited to practitioners who performed at least one of the 293
  relevant global procedures and were affiliated with a tax
  identification number with 10 or more practitioners.

[[Page 35735]]

 
** Practitioners who submitted one or more CPT code 99024 claims between
  July 1st, 2017 and December 31st, 2017.

    Among 10-day global procedures performed from July 1, 2017 through 
December 31, 2017, where it is possible to clearly match postoperative 
visits to specific procedures, only 4 percent had one or more matched 
visit reported with CPT code 99024. The percentage of 10-day global 
procedures with a matched visit reported with CPT code 99024 varied by 
specialty. Among procedures with 10-day global periods performed by 
hand surgeons, critical care, and obstetrics/gynecology 44, 36, and 23 
percent, respectively, of procedures had a matched visit reported using 
CPT code 99024. In contrast, less than 5 percent of 10-day global 
procedures performed by many other specialties had a matched visit 
reported using CPT code 99024. (See Table 11.)

                        Table 11--Share of Procedures With Matched Post-Operative Visits
----------------------------------------------------------------------------------------------------------------
                                                                              Number of 10-day  Percentage of 10-
                                                                                   global          day global
                                                            Number of 10-day   procedures with   procedures with
                    Provider specialty                           global           1 or more         1 or more
                                                              procedures *      matched 99024     matched 99024
                                                                                  claims **         claims **
----------------------------------------------------------------------------------------------------------------
ALL.......................................................           436,063            16,802                 4
Dermatology...............................................           205,594             6,920                 3
Physician Assistant.......................................            57,749               908                 2
Nurse Practitioner........................................            31,937               509                 2
Family practice...........................................            16,770               629                 4
Ophthalmology.............................................            16,087             1,239                 8
Podiatry..................................................            12,639               547                 4
General surgery...........................................            12,113             2,095                17
Diagnostic radiology......................................            11,650               298                 3
Neurology.................................................             8,075                68                 1
Pain Management...........................................             6,923               210                 3
Emergency medicine........................................             6,012               209                 3
Internal medicine.........................................             5,883               201                 3
Interventional Pain Management............................             5,210               106                 2
Anesthesiology............................................             4,666               105                 2
Otolaryngology............................................             4,598               383                 8
Interventional radiology..................................             4,197                89                 2
Physical medicine and rehabilitation......................             3,546                53                 1
Vascular surgery..........................................             3,447               256                 7
Gastroenterology..........................................             2,264                 7                 0
Plastic and reconstructive surgery........................             1,939               403                21
Colorectal surgery........................................             1,851                83                 4
General practice..........................................             1,807                45                 2
Orthopedic surgery........................................             1,688               318                19
Optometry.................................................             1,563                45                 3
Urology...................................................             1,276               277                22
Neurosurgery..............................................             1,148               241                21
Nephrology................................................             1,008                25                 2
Obstetrics/gynecology.....................................               760               171                23
Cardiology................................................               456                14                 3
Surgical oncology.........................................               440                41                 9
Pathology.................................................               395                76                19
Pediatric medicine........................................               323                 4                 1
Neuropsychiatry...........................................               296                 2                 1
Thoracic surgery..........................................               276                40                14
Gynecologist/oncologist...................................               266                47                18
Interventional Cardiology.................................               192                 5                 3
Peripheral vascular disease, medical or surgical..........               162                 5                 3
Cardiac surgery...........................................               144                25                17
Hand surgery..............................................               124                54                44
Critical care.............................................                85                30                35
Infectious disease........................................                67                 3                 4
Osteopathic manipulative therapy..........................                55                 1                 2
Psychiatry................................................                44                 0                 0
Geriatric medicine........................................                43                 0                 0
Hospitalist...............................................                42                 0                 0
Maxillofacial surgery.....................................                37                 5                14
Oral surgery..............................................                34                 1                 3
Radiation oncology........................................                31                 1                 3
Certified clinical nurse specialist.......................                26                 2                 8
Pulmonary disease.........................................                20                 2                10
Hematology/oncology.......................................                19                 0                 0
Peripheral vascular disease...............................                17                 0                 0
Preventive medicine.......................................                15                 0                 0
Pathologic anatomy, clinical pathology....................                12                 1                 8

[[Page 35736]]

 
Unknown physician specialty...............................                10                 3                30
----------------------------------------------------------------------------------------------------------------
* Limited to the 293 procedures where postoperative visit reporting is required and to those performed by
  practitioners who work in practices with 10 or more practitioners. Because matching may be unclear in these
  circumstances, multiple procedures performed on a single day and procedures with overlapping global periods
  were excluded.
** Matching was based on patient, service dates, and global period duration.

    Among 90-day global procedures performed from July 1, 2017 through 
December 31, 2017, where it is possible to clearly match postoperative 
visits to specific procedures, 67 percent had one or more matched visit 
reported using CPT code 99024. Again, this rate varied by specialty as 
shown in Table 12. Under the PFS, procedures with 90-day global periods 
have more than one postoperative visit. It should be noted that the 
rates described in this and prior paragraphs are based on any matched 
postoperative visit reported using CPT code 99024.

Table 12--Share of Procedures With Matched Post-Operative Visits, for Procedure Codes With 90-Day Global Periods
----------------------------------------------------------------------------------------------------------------
                                                                              Number of 90-day  Percentage of 90-
                                                                                   global          day global
                                                            Number of 90-day   procedures with   procedures with
                    Provider specialty                           global           1 or more         1 or more
                                                               procedures*      matched 99024     matched 99024
                                                                                  claims**          claims**
----------------------------------------------------------------------------------------------------------------
ALL.......................................................           232,235           156,727                67
Orthopedic surgery........................................            71,991            54,876                76
Ophthalmology.............................................            63,333            41,700                66
General surgery...........................................            25,593            17,559                69
Pathologic anatomy, clinical pathology....................            10,149             4,371                43
Urology...................................................             8,481             4,828                57
Dermatology...............................................             7,692             4,160                54
Neurosurgery..............................................             6,993             5,256                75
Cardiology................................................             5,932             2,388                40
Vascular surgery..........................................             5,400             3,552                66
Hand surgery..............................................             4,783             3,718                78
Thoracic surgery..........................................             3,700             2,859                77
Cardiac surgery...........................................             2,764             2,183                79
Plastic and reconstructive surgery........................             2,500             1,670                67
Podiatry..................................................             2,383             1,393                58
Otolaryngology............................................             1,692             1,014                60
Physician Assistant.......................................             1,492               903                61
Colorectal surgery........................................             1,316               869                66
Interventional Cardiology.................................             1,123               500                45
Peripheral vascular disease, medical or surgical..........               753               524                70
Obstetrics/gynecology.....................................               752               469                62
Surgical oncology.........................................               716               511                71
Optometry.................................................               402               248                62
Gynecologist/oncologist...................................               322               219                68
Internal medicine.........................................               317               133                42
Emergency medicine........................................               258                62                24
Nurse Practitioner........................................               243               153                63
General practice..........................................               217               125                58
Gastroenterology..........................................               139                13                 9
Osteopathic manipulative therapy..........................               131                94                72
Family practice...........................................               115                65                57
Critical care.............................................                98                77                79
Neurology.................................................                87                64                74
Interventional radiology..................................                65                22                34
Unknown physician specialty...............................                60                34                57
Diagnostic radiology......................................                50                 6                12
Nephrology................................................                33                21                64
Maxillofacial surgery.....................................                29                23                79
Physical medicine and rehabilitation......................                26                16                62
Interventional Pain Management............................                14                 2                14
Pathology.................................................                13                 3                23
Hematology/oncology.......................................                12                12               100

[[Page 35737]]

 
Peripheral vascular disease...............................                10                 5                50
----------------------------------------------------------------------------------------------------------------
* Limited to the 293 procedures where post-operative visit reporting is required and to those performed by
  practitioners who work in practices with 10 or more practitioners. Because matching may be unclear in these
  circumstances, multiple procedures performed on a single day and procedures with overlapping global periods
  were excluded.
** Matching was based on patient, service dates, and global period duration.

    One potential explanation for these findings is that many 
practitioners are not consistently reporting postoperative visits using 
CPT code 99024. We are soliciting suggestions as to how to encourage 
reporting to ensure the validity of the data without imposing undue 
burden. Specifically, we are soliciting comments on whether we need to 
do more to make practitioners aware of their obligation and whether we 
should consider implementing an enforcement mechanism.
    Given the very small number of postoperative visits reported using 
CPT code 99024 during 10-day global periods, we are seeking comment on 
whether or not it might be reasonable to assume that many visits 
included in the valuation of 10-day global packages are not being 
furnished, or whether there are alternative explanations for what could 
be a significant level of underreporting of postoperative visits. For 
example, we are soliciting comments on whether it is likely that in 
many cases the practitioner reporting the procedure code is not 
performing the postoperative visit, or if the postoperative visit is 
being furnished by a different practitioner. Alternatively, we are 
soliciting comments on whether it is possible that some or all of the 
postoperative visits are occurring after the global period ends and 
are, therefore, reported and paid separately.
    We conducted an analysis to try to assess the extent of 
underreporting. We identified a set of ``robust reporters'' who 
appeared to be regularly reporting post-operative visits using CPT code 
99024. They were defined as practitioners who (a) furnished 10 or more 
procedures with 90-day global periods where it is possible for us to 
match specific procedures to reported post-operative visits without 
ambiguity, and (b) reported a post-operative visit using CPT code 99024 
for at least half of these 90-day global procedures. Among this subset 
of practitioners and procedures, we found that 87 percent of procedures 
with 90-day global periods had one or more associated post-operative 
visits. However, only 16 percent of procedures with a 10-day global 
period had an associated postoperative visit reported using CPT code 
99024. These findings suggest that post-operative visits following 
procedures with 10-day global periods are not typically being furnished 
rather than not being reported.
    Under current policy, in cases where practitioners agree on the 
transfer of care for the postoperative portion of the global period, 
the surgeon bills only for the surgical care using modifier 54 ``for 
surgical care only'' and the practitioner who furnishes the 
postoperative care bills using modifier 55 ``postoperative management 
only.'' The global surgery payment is then split between the two 
practitioners. However, practitioners are not required to report these 
modifiers unless there is a formal transfer of postoperative care. We 
are also soliciting comments on whether we should consider requiring 
use of the modifiers in cases where the surgeon does not expect to 
perform the postoperative visits, regardless of whether or not the 
transfer of care is formalized.
    We are also seeking comment on the best approach to 10-day global 
codes for which the preliminary data suggest that postoperative visits 
are rarely performed by the practitioner reporting the global code. 
That is, we are seeking comments on whether we should consider changing 
the global period and reviewing the code valuation.
    Finally, we note that claims-based data collection using CPT code 
99024 is intended to collect information on the number of post-
operative visits but not the level of post-operative visits. We 
anticipate beginning, in the near future, a separate survey-based data 
collection effort on the level of post-operative visits including the 
time, staff, and activities involved in furnishing post-operative 
visits and non-face-to-face services. The survey component is intended 
to address concerns from the physician community that information on 
the number of visits alone cannot capture differences between 
specialties, specific procedure codes, and setting in terms of the time 
and effort spent on post-operative visits and non-face-to-face services 
included in global periods.
    RAND developed a survey that collects information on the time, 
staff, and activities related to five post-operative visits furnished 
by sampled practitioners. The CY 2017 PFS final rule (81 FR 80222) 
described a sampling approach for the survey that would have collected 
data on post-operative visits related to the full range of procedures 
with 10-day and 90-day global periods using a stratified random sample 
of approximately 5,000 practitioners. RAND piloted the post-operative 
visit survey in a small subsample of practitioners and found a very low 
response rate. This low response rate raised concerns that the survey 
would not yield useful or representative information on post-operative 
visits if the survey were fielded in the full sample.
    In an effort to increase response rate and collect sufficient data 
on the level of visits associated with at least some procedures with 
10-day and 90-day global periods, we refocused the survey effort to 
collect information on post-operative visits and non-face-to-face 
services associated with a small number of high-volume procedure codes. 
The survey sampling frame includes practitioners who perform above a 
threshold volume of the selected high-volume procedure codes. 
Practitioner participation in the survey-based data collection effort 
is important to ensure that CMS collects useful and representative data 
to understand the range of activities, staff, and time involved in 
furnishing post-operative visits. Future survey-based data collection 
may cover post-operative visits and non-face-to-face services 
associated with a broader range of procedures with 10-day and 90-day 
global periods.

[[Page 35738]]

F. Radiologist Assistants

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

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

1. Background
    Sections 1833(t)(1)(B)(v) and (t)(21) of the Act require that 
certain items and services furnished by certain off-campus provider-
based departments (PBDs) (collectively referenced here as nonexcepted 
items and services furnished by nonexcepted off-campus PBDs) shall not 
be considered covered outpatient department services for purposes of 
payment under the Hospital Outpatient Prospective Payment System 
(OPPS), and payment for those nonexcepted items and services furnished 
on or after January 1, 2017 shall be made under the applicable payment 
system under Medicare Part B if the requirements for such payment are 
otherwise met. These requirements were enacted in section 603 of the 
Bipartisan Budget Act of 2015 (Pub. L. 114-74). In the CY 2017 OPPS/
Ambulatory Surgical Center (ASC) final rule with comment period (81 FR 
79699 through 79719), we established several policies and provisions to 
define the scope of nonexcepted items and services in nonexcepted off-
campus PBDs. We also finalized the PFS as the applicable payment system 
for most nonexcepted items and services furnished by nonexcepted off-
campus PBDs. At the same time, we issued an interim final rule with 
comment period (81 FR 79720 through 79729) in which we established 
payment policies under the PFS for nonexcepted items and services 
furnished on or after January 1, 2017. In the following paragraphs, we 
summarize the policies that we adopted for CY 2017 and CY 2018, and we 
propose payment policies for CY 2019. For issues related to the 
excepted status of off-campus PBDs or the excepted status of items and 
services, please see the CY 2019 OPPS/ASC proposed rule.
2. Payment Mechanism
    In establishing the PFS as the applicable payment system for most 
nonexcepted items and services in nonexcepted off-campus PBDs under 
sections 1833(t)(1)(B)(v) and (t)(21) of the Act, we recognized that 
there was no technological capability, at least in the near term, to 
allow off-campus PBDs to bill under the PFS for those nonexcepted items 
and services. Off-campus PBDs bill under the OPPS for their services on 
an institutional claim, while physicians and other suppliers bill under 
the PFS on a practitioner claim. The two systems that process these 
different types of claims, the Fiscal Intermediary Standard System 
(``FISS'') and the Multi-Carrier System (``MCS'') system, respectively, 
were not designed to accept or process claims of a different type. To 
permit an off-campus PBD to bill directly under a different payment 
system than the OPPS would have required significant changes to these 
complex systems as well as other systems involved in the processing of 
Medicare Part B claims. Consequently, we proposed and finalized a 
policy for CY 2017 and CY 2018 in which nonexcepted off-campus PBDs 
continue to bill for nonexcepted items and services on the 
institutional claim utilizing a new claim line modifier ``PN'' to 
indicate that an item or service is a nonexcepted item or service.
    We implemented requirements under section 1833(t)(1)(B) of the Act 
for CY 2017 and CY 2018 by applying an overall downward scaling factor, 
called

[[Page 35739]]

the PFS Relativity Adjuster to payments for nonexcepted items and 
services furnished in nonexcepted off campus PBDs. The PFS Relativity 
Adjuster generally reflects the average (weighted by claim line volume 
times rate) of the site-specific rate under the PFS compared to the 
rate under the OPPS (weighted by claim line volume times rate) for 
nonexcepted items and services furnished in nonexcepted off-campus 
PBDs. As we have discussed extensively in prior rulemaking (81 FR 97920 
through 97929 and 82 FR 53021), we established a new set of site-
specific payment rates under the PFS that reflect the relative resource 
cost of furnishing the technical component (TC) of services furnished 
in nonexcepted off-campus PBDs. For the majority of HCPCS codes, these 
rates are based on either (1) the difference between the PFS 
nonfacility payment rate and the PFS facility rate, (2) the technical 
component, or (3) in instances where payment would have been made only 
to the facility or to the physician, the full nonfacility rate. The PFS 
Relativity Adjuster refers to the percentage of the OPPS payment amount 
paid under the PFS for a nonexcepted item or service to the nonexcepted 
off-campus PBD.
    To operationalize the PFS Relativity Adjuster as a mechanism to pay 
for nonexcepted items and services furnished by nonexcepted off-campus 
PBDs, we adopted the packaging payment rates and multiple procedure 
payment reduction (MPPR) percentage that applies under the OPPS. We 
also incorporated the claims processing logic that is used for payments 
under the OPPS for comprehensive APCs (C-APCs), conditionally and 
unconditionally packaged items and services, and major procedures. As 
we noted in the CY 2017 interim final rule (82 FR 53024), we believe 
that this maintains the integrity of the cost-specific relativity of 
current payments under the OPPS compared with those under the PFS.
    In CY 2017, we implemented a PFS Relativity Adjuster of 50 percent 
of the OPPS rate for nonexcepted items and services furnished in 
nonexcepted off-campus PBDs. For a detailed explanation of how we 
developed the PFS Relativity Adjuster of 50 percent for CY 2017, 
including assumptions and exclusions, we refer readers to the CY 2017 
OPPS/ASC interim final rule with comment period (81 FR 79720 through 
79729). Beginning for CY 2018, we adopted a PFS Relativity Adjuster of 
40 percent of the OPPS rate. For a detailed explanation of how we 
developed the PFS Relativity Adjuster of 40 percent, we refer readers 
to the CY 2018 PFS final rule (82 FR 53019 through 53042). A brief 
overview of the general approach we took for CY 2018 and how it differs 
from the proposal for CY 2019 appears below.
3. The PFS Relativity Adjuster
    The PFS Relativity Adjuster reflects the overall relativity of the 
applicable payment rate for nonexcepted items and services furnished in 
nonexcepted off-campus PBDs under the PFS compared with the rate under 
the OPPS. To develop the PFS Relativity Adjuster for CY 2017, we did 
not have all of the claims data needed to identify the mix of items and 
services that would be billed using the ``PN'' modifier. Instead, we 
analyzed hospital outpatient claims data from January 1 through August 
25, 2016, that contained the ``PO'' modifier, which was a new mandatory 
reporting requirement for CY 2016 for claims that were billed by an 
off-campus department of a hospital. We limited our analysis to those 
claims billed on the 13X Type of Bill because those claims were used 
for Medicare Part B billing under the OPPS. We then identified the 25 
most frequently billed major codes that were billed by claim line; that 
is, items and services that were separately payable or conditionally 
packaged. Specifically, we restricted our analysis to codes with OPPS 
status indicators (SI) ``J1'', ``J2'', ``Q1'', ``Q2'', ``Q3'', ``S'', 
``T'', or ``V''. The most frequently billed service with the ``PO'' 
modifier in CY 2016 was described by HCPCS code G0463 (Hospital 
outpatient clinic visit for the assessment and management of a 
patient), which, in CY 2016, was paid under APC 5012 at a rate of 
$102.12; the total number of claim lines for this service was 
approximately 6.7 million as of August 2016. Under the PFS, there are 
ten CPT codes describing different levels of office visits for new and 
established payments. We compared the payment rate under OPPS for G0463 
($102.12) to the average of the difference between the nonfacility and 
facility rates for CPT code 99213 (Level III office visit for an 
established patient) and CPT code 99214 (Level IV office visit for an 
established patient) in CY 2016 and found that the relative payment 
difference was approximately 22 percent. We did not include HCPCS code 
G0463 in our calculation of the PFS Relativity Adjuster for CY 2017 
because we were concerned that there was no single, directly comparable 
code under the PFS. As we stated in the CY 2017 interim final rule (81 
FR 79723), we wanted to mitigate the risk of underestimating the 
overall relativity between the PFS and OPPS rates. From the remaining 
top 24 most frequently billed codes, we excluded HCPCS code 36591 
(Collection of blood specimen from a completely implantable venous 
access device) because, under PFS policies, the service was only 
separately payable under the PFS when no other code was on the claim. 
We also removed HCPCS code G0009 (Administration of Pneumococcal 
Vaccine) because there was no payment for this code under the PFS. For 
the remaining top 22 codes furnished with the ``PO'' modifier in CY 
2016, the average (weighted by claim line volume times rate) of the 
nonfacility payment rate estimate for the PFS compared to the estimate 
for the OPPS was 45 percent. We indicated that, because of our 
inability to estimate the effect of the packaging difference between 
the OPPS and the PFS, we would assume a 5 percentage point adjustment 
upward from the calculated amount of 45 percent; therefore, we 
established the PFS Relativity Adjuster of 50 percent for CY 2017.
    In establishing the PFS Relativity Adjuster for CY 2018, we still 
did not have claims data for items and services furnished reported with 
a ``PN'' modifier. However, we updated the list of the 25 most 
frequently billed HCPCS codes using an entire year (CY 2016) of claims 
data for services submitted with a ``PO'' modifier and we updated the 
corresponding utilization weights for the codes used in the analysis. 
The order and composition of the top 25 separately payable HCPCS codes, 
based on the full year of claims from CY 2016 submitted with the ``PO'' 
modifier, changed minimally from the codes we used in our original 
analysis for the CY 2017 OPPS/ASC interim final rule with comment 
period. For a detailed list of the HCPCS codes we used in calculating 
the CY 2017 PFS Relativity Adjuster and the CY 2018 PFS Relativity 
Adjuster, we refer readers to the CY 2018 PFS final rule (82 FR 53030 
through 53031). As noted earlier, in establishing the PFS Relativity 
Adjuster of 50 percent for CY 2017, we did not include in the weighted 
average code comparison, the relative rate for the most frequently 
billed service furnished in off-campus PBDs, HCPCS code G0463 (Hospital 
outpatient clinic visit for assessment and management of a patient), in 
part to ensure that we were not underestimating the overall relativity 
between the PFS and the OPPS. In contrast, in the CY 2018 PFS final 
rule, we stated that our objective for CY 2018 was to ensure that we 
did not overestimate the appropriate overall payment relativity, and 
that the payment made to nonexcepted off-campus PBDs better aligned 
with the

[[Page 35740]]

services that are most frequently furnished in the setting. Therefore, 
in addition to using updated claims data, we revised the PFS Relativity 
Adjuster to incorporate the relative payment rate for HCPCS code G0463 
into our analysis. We followed all other exclusions and assumptions 
that were made in calculating the CY 2017 PFS Relativity Adjuster. Our 
analysis resulted in a 35 percent relative difference in payment rates. 
Similar to our stated rationale in the CY 2017 PFS final rule, we 
increased the PFS Relativity Adjuster to 40 percent, acknowledging the 
difficulty of estimating the effect of the packaging differences 
between the OPPS and the PFS.
4. Proposed Payment Policies for CY 2019
    In prior rulemaking, we stated our expectation that our general 
approach of adjusting OPPS payments using a single scaling factor, the 
PFS Relativity Adjuster, would continue to be an appropriate payment 
mechanism to implement provisions of section 603 of the Bipartisan 
Budget Act of 2015, and would remain in place until we are able to 
establish code-specific reductions that represent the technical 
component of services furnished under the PFS or until we are able to 
implement system changes needed to enable nonexcepted off-campus PBDs 
to bill for nonexcepted items and services under the PFS directly (82 
FR 53029). As we continue to explore alternative options related to 
requirements under section 1833(t)(21)(C) of the Act, we believe that 
this overall approach is still appropriate, and we are proposing to 
continue to allow nonexcepted off-campus PBDs to bill for nonexcepted 
items and services on an institutional claim using a ``PN'' modifier 
until we identify a workable alternative mechanism that would improve 
payment accuracy.
    We made several adjustments to our methodology for calculating the 
PFS Relativity Adjuster for CY 2019. Most importantly, we had access to 
a full year of claims data from CY 2017 for services submitted with the 
``PN'' modifier. Incorporating these data allows us to improve the 
accuracy of the PFS Relativity Adjuster by accounting for the specific 
mix of nonexcepted items and services furnished in nonexcepted off-
campus PBDs. In analyzing the CY 2017 claims data, we identified just 
under 2,000 unique OPPS HCPCS/SI pairs reported in CY 2017 with status 
indicators ``J1'', ``J2'', ``Q1'', ``Q2'', ``Q3'', ``S'', ``T'', or 
``V''. The data reinforce our previous observation that the single most 
frequently reported service furnished in nonexcepted off-campus PBDs is 
HCPCS code G0463 (Hospital outpatient clinic visit for assessment and 
management of a patient). Nearly half (49 percent) of all claim lines 
for separately payable or conditionally packaged services furnished by 
nonexcepted off-campus PBDs included HCPCS code G0463 in CY 2017, 
representing 30 percent of total Medicare payments for separately 
payable or conditionally packaged services. The top 30 HCPCS/SI 
combinations accounted for 80 percent of all claim lines and 
approximately 60 percent of Medicare payments for services that are 
separately billable. In contrast with prior analyses, we also looked at 
claims units, which reflects HCPCS/SI combinations that are billed more 
than once on a claim line. Certain HCPCS codes are much more frequently 
billed in multiple units than others. For instance, HCPCS code G0463, 
which appears in nearly half of all claim lines, only represents eight 
percent of all claims units with a SI for separately payable or 
conditionally packaged services. The largest differences between the 
number of claim lines and the number of claims units are for injections 
and immunizations, which are not typically separately payable or 
conditionally packaged under the OPPS. For instance, HCPCS code Q9967 
(Low osmolar contrast material, 300-399 mg/ml iodine concentration, per 
ml) was reported in 12,268 claim lines, but 1,168,393 times (claims 
units) in the aggregate. HCPCS code Q9967 has an OPPS status indicator 
of ``N'', meaning that there is no separate payment under OPPS (items 
and services are packaged into APC rates).
    To calculate the PFS Relativity Adjuster using the full range of 
claims data submitted with a ``PN'' modifier in CY 2017, we first 
established site-specific rates under the PFS that reflect the 
technical component (TC) of items and services furnished by nonexcepted 
off-campus PBDs in CY 2017. These HCPCS-level rates reflect our best 
current estimate of the amount that would have been paid for the 
service in the office setting under the PFS for practice expenses not 
associated with the professional component of the service. As discussed 
in prior rulemaking (81 FR 79720 through 79729), we believe the most 
appropriate code-level comparison would reflect the technical component 
(TC) of each HCPCS code under the PFS. However, we do not currently 
calculate a separate TC rate for all HCPCS codes under the PFS--only 
for those for which the professional component (PC) and TC of the 
service are distinct and can be separately billed by two different 
practitioners or other suppliers under the PFS. For most of the 
remainder of services that do not have a separately payable TC under 
the PFS, we estimated the site-specific rate as (1) the difference 
between the PFS nonfacility rate and the PFS facility rate, or (2) in 
instances where payment would have been made only to the facility or 
only to the physician, the full nonfacility rate. As with the PFS rates 
that we developed when calculating the PFS Relativity Adjuster for CY 
2017 and CY 2018, there were large code-level differences between the 
applicable PFS rate and the OPPS rate.
    In calculating the proposed PFS Relativity Adjuster for CY 2019, we 
employed the same fundamental methodology that we used to calculate the 
PFS Relativity Adjuster for CY 2017 and CY 2018. We began by limiting 
our analysis to the items and services billed in CY 2017 with a ``PN'' 
modifier that are separately payable or conditionally packaged under 
the OPPS (SI = ``J1'', ``J2'', ``Q1'', ``Q2'', ``Q3'', ``S'', ``T'', or 
``V'') and compared the rates for these codes under the OPPS with the 
site-specific rates under the PFS. Next, we imputed PFS rates for a 
limited number of items and services that are separately payable or 
conditionally packaged under the OPPS but are contractor priced under 
the PFS. We also imputed PFS rates for some HCPCS codes that are not 
separately payable under the OPPS (SI = ``N''), but are separately 
payable under the PFS. This includes items and services with an 
indicator status of `X' under the PFS, which are statutorily excluded 
from payment under the PFS, but may be paid under a different fee 
schedule, such as the Clinical Lab Fee Schedule (CLFS). We summed the 
HCPCS-level rates under the PFS across all nonexcepted items and 
services, weighted by the number of HCPCS claims for each service. 
Next, we calculated the sum of the HCPCS-level OPPS rate for items and 
services that are separately payable or conditionally packaged, also 
weighted by the number of HCPCS claims. We compared the weighted sum of 
the site-specific PFS rate with the weighted sum of the OPPS rate for 
items and services reported in CY 2017 and we found that our updated 
analysis supports maintaining a PFS Relativity Adjuster of 40 percent. 
In view of this analysis, we propose to continue applying a PFS 
Relativity Adjuster of 40 percent for CY 2019. Moreover, we propose to 
maintain this PFS Relativity Adjuster for future years

[[Page 35741]]

until updated data or other considerations indicate that an alternative 
adjuster or a change to our approach is warranted, which we would then 
propose through notice and comment rulemaking. We discuss some of our 
ongoing data analyses and future plans regarding implementation of 
section 603 of the Bipartisan Budget Act of 2015 below.
5. Policies Related to Supervision, Beneficiary Cost-Sharing, and 
Geographic Adjustments
    In the CY 2018 PFS final rule (81FR 53019 through 53031), we 
finalized policies related to supervision rules, beneficiary cost 
sharing, and geographic adjustments. We finalized that supervision 
rules in nonexcepted off-campus PBDs that furnish nonexcepted items and 
services are the same as those that apply for hospitals, in general. We 
also finalized that all beneficiary cost sharing rules that apply under 
the PFS in accordance with sections 1848(g) and 1866(a)(2)(A) of the 
Act continue to apply when payment is made under the PFS for 
nonexcepted items and services furnished by nonexcepted off-campus 
PBDs, regardless of cost sharing obligations under the OPPS. Lastly, we 
finalized the policy to apply the same geographic adjustments used 
under the OPPS to nonexcepted items and services furnished in 
nonexcepted off-campus PBDs. We note that we are maintaining these 
policies as finalized in CY 2018 PFS final rule.
6. Partial Hospitalization
a. Partial Hospitalization Services
    Partial hospitalization programs (PHPs) are intensive outpatient 
psychiatric day treatment programs furnished to patients as an 
alternative to inpatient psychiatric hospitalization, or as a stepdown 
to shorten an inpatient stay and transition a patient to a less 
intensive level of care. Section 1861(ff)(3)(A) of the Act specifies 
that a PHP is a program furnished by a hospital, to its outpatients, or 
by a Community Mental Health Center (CMHC). In the CY 2017 OPPS/ASC 
proposed rule (81 FR 45690), in the discussion of the proposed 
implementation of section 603 of Bipartisan Budget Act of 2015, we 
noted that because CMHCs also furnish PHP services and are ineligible 
to be provider-based to a hospital, a nonexcepted off-campus PBD would 
be eligible for PHP payment if the entity enrolls and bills as a CMHC 
for payment under the OPPS. We further noted that a hospital may choose 
to enroll a nonexcepted off-campus PBD as a CMHC, provided it meets all 
Medicare requirements and conditions of participation.
    Commenters expressed concern that without a clear payment mechanism 
for PHP services furnished by nonexcepted off-campus PBDs, access to 
partial hospitalization services would be limited, and pointed out the 
critical role PHPs play in the continuum of mental health care. Many 
commenters believed that the Congress did not intend for partial 
hospitalization services to no longer be paid for by Medicare when such 
services are furnished by nonexcepted off-campus PBDs. Several 
commenters disagreed with the notion of enrolling as a CMHC in order to 
receive payment for PHP services. These commenters stated that 
hospital-based PHPs and CMHCs are inherently different in structure, 
operation, and payment, and noted that the conditions of participation 
for hospital departments and CMHCs are different. Several commenters 
requested that CMS find a mechanism to pay hospital-based PHPs in 
nonexcepted off-campus PBDs.
    Because we shared the commenters' concerns, in the CY 2017 OPPS/ASC 
final rule with comment period and interim final rule with comment 
period (81 FR 79715, 79717, and 79727), we adopted payment for partial 
hospitalization items and services furnished by nonexcepted off-campus 
PBDs under the PFS. When billed in accordance with the CY 2017 interim 
final rule, these partial hospitalization services are paid at the CMHC 
per diem rate for APC 5853, for providing three or more partial 
hospitalization services per day (81 FR 79727).
    In the CY 2017 OPPS/ASC proposed rule (81 FR 45681), the CY 2017 
OPPS/ASC final rule with comment period, and the interim final rule 
with comment period (81 FR 79717 and 79727), we noted that when a 
beneficiary receives outpatient services in an off-campus department of 
a hospital, the total Medicare payment for those services is generally 
higher than when those same services are provided in a physician's 
office. Similarly, when partial hospitalization services are provided 
in a hospital-based PHP, Medicare pays more than when those same 
services are provided by a CMHC. Our rationale for adopting the CMHC 
per diem rate for APC 5853 as the PFS payment amount for nonexcepted 
off-campus PBDs providing PHP services is because CMHCs are 
freestanding entities that are not part of a hospital, but they provide 
the same PHP services as hospital-based PHPs (81 FR 79727). This is 
similar to the differences between freestanding entities paid under the 
PFS that furnish other services also provided by hospital-based 
entities. Similar to other entities currently paid for their technical 
component services under the PFS, we believe CMHCs would typically have 
lower cost structures than hospital-based PHPs, largely due to lower 
overhead costs and other indirect costs such as administration, 
personnel, and security. We believe that paying for nonexcepted 
hospital-based partial hospitalization services at the lower CMHC per 
diem rate aligns with section 603 of Bipartisan Budget Act of 2015, 
while also preserving access to PHP services. In addition, nonexcepted 
off-campus PBDs will not be required to enroll as CMHCs in order to 
bill and be paid for providing partial hospitalization services. 
However, a nonexcepted off-campus PBD that wishes to provide PHP 
services may still enroll as a CMHC if it chooses to do so and meets 
the relevant requirements. Finally, we recognize that because hospital-
based PHPs are providing partial hospitalization services in the 
hospital outpatient setting, they can offer benefits that CMHCs do not 
have, such as an easier patient transition to and from inpatient care, 
and easier sharing of health information between the PHP and the 
inpatient staff.
    In the CY 2018 PFS final rule, we did not require these PHPs to 
enroll as CMHCs but instead we continued to pay nonexcepted off-campus 
PBDs providing PHP items and services under the PFS. Further, in that 
CY 2018 PFS final rule, we continued to adopt the CMHC per diem rate 
for APC 5853 as the PFS payment amount for nonexcepted off-campus PBDs 
providing three or more PHP services per day in CY 2018 (82 FR 53025 to 
53026).
    For CY 2019, we propose to continue to identify the PFS as the 
applicable payment system for PHP services furnished by nonexcepted 
off-campus PBDs, and propose to continue to set the PFS payment rate 
for these PHP services as the per diem rate that would be paid to a 
CMHC in CY 2019. We further propose to maintain these policies for 
future years until updated data or other considerations indicate that a 
change to our approach is warranted, which we would then propose 
through notice and comment rulemaking.
7. Future Years
    We continue to believe the amendments made by section 603 of the 
Bipartisan Budget Act of 2015 were intended to eliminate the Medicare 
payment incentive for hospitals to purchase physician offices, convert 
them to off-campus PBDs, and bill

[[Page 35742]]

under the OPPS for items and services they furnish there. Therefore, we 
continue to believe the payment policy under this provision should 
ultimately equalize payment rates between nonexcepted off-campus PBDs 
and physician offices to the greatest extent possible, while allowing 
nonexcepted off-campus PBDs to bill in a straight-forward way for 
services they furnish.
    Under the proposed methodology for CY 2019 as described previously, 
we use updated claims data for CY 2019, in combination with the 
expanded number of site specific, technical component rates for 
nonexcepted items and services furnished in nonexcepted off campus 
PBDs, in order to ensure that Medicare payment to hospitals billing for 
nonexcepted items and services furnished by nonexcepted off-campus PBDs 
reflects the relative resources involved in furnishing the items and 
services. We recognize that for certain specialties, service lines, and 
nonexcepted off-campus PBD types, total Medicare payments for the same 
services might be either higher or lower when furnished by a 
nonexcepted off-campus PBD rather than in a physician office. We also 
note that our approach adopts packaging rules and MPPR rules under the 
OPPS.
    As noted above, we intend to continue to examine the claims data in 
order to assess whether a different PFS Relativity Adjuster is 
warranted and also to consider whether additional adjustments to the 
methodology are appropriate. In particular, we are monitoring claims 
for shifts in the mix of services furnished in nonexcepted off campus 
PBDs that may affect the relativity between the PFS and OPPS. An 
increase over time in the share of nonexcepted items and services with 
lower technical component rates under the PFS compared with APC rates 
under the OPPS might result in a lower PFS Relativity Adjuster, for 
example. We will also carefully assess annual payment policy updates to 
the PFS and OPPS fee schedule rules, respectively, to identify changes 
in overall relativity resulting from any new or modified policies such 
as expanded packaging under the OPPS or an increase in the number of 
HCPCS codes with global periods under the PFS. As part of these ongoing 
efforts, we are also analyzing PFS claims data to identify patterns of 
services furnished together on the same day. We anticipate that this 
will ultimately allow us to make refinements to the PFS Relativity 
Adjuster to better account for the more extensive packaging of services 
under the OPPS and the potential underreporting of services that are 
not separately payable under the OPPS but are paid separately under the 
PFS.
    Another dimension of our ongoing efforts to improve implementation 
of section 603 of the Bipartisan Budget Act of 2015 is the development 
and refinement of a new set of payment rates under the PFS that reflect 
the relative resource costs of furnishing the technical component of 
items and services furnished in nonexcepted off campus PBDs. Although 
we believe that our site-specific HCPCS-level rates reflect the best 
available estimate of the amount that would have been paid for the 
service in the office setting under the PFS for practice expenses not 
associated with the professional component of the service, for the 
majority of HCPCS codes there is no established methodology for 
separately valuing the resource costs incurred by a provider while 
furnishing a service from those incurred exclusively by the facility in 
which the service is furnished. We continue to explore alternatives to 
our current estimates that would better reflect the TC of services 
furnished in nonexcepted off campus PBDs. We are broadly interested in 
stakeholder feedback and recommendations for ways in which CMS can 
improve pricing and transparency with regard to the differences in the 
payment rates across sites of service.
    We expect that our continued analyses of claims data and our 
ongoing exploration of systems changes that are needed to allow 
nonexcepted off campus PBDs to bill directly for the TC portion of 
nonexcepted items and services may lead us to consider a different 
approach for implementing section 603 of the Bipartisan Budget Act of 
2015. On the whole, however, we believe that the proposed PFS 
Relativity Adjuster for CY 2019 of 40 percent would advance the effort 
to equalize payment rates in the aggregate between physician offices 
and nonexcepted off-campus PBDs. Maintaining our policy of applying an 
overall scaling factor to OPPS payments allows hospitals to continue 
billing through a facility claim form and permits continued use of the 
packaging rules and cost report-based relative payment rate 
determinations for nonexcepted services.

H. Valuation of Specific Codes

1. Background: Process for Valuing New, Revised, and Potentially 
Misvalued Codes
    Establishing valuations for newly created and revised CPT codes is 
a routine part of maintaining the PFS. Since the inception of the PFS, 
it has also been a priority to revalue services regularly to make sure 
that the payment rates reflect the changing trends in the practice of 
medicine and current prices for inputs used in the PE calculations. 
Initially, this was accomplished primarily through the 5-year review 
process, which resulted in revised work RVUs for CY 1997, CY 2002, CY 
2007, and CY 2012, and revised PE RVUs in CY 2001, CY 2006, and CY 
2011, and revised MP RVUs in CY 2010 and CY 2015. Under the 5-year 
review process, revisions in RVUs were proposed and finalized via 
rulemaking. In addition to the 5-year reviews, beginning with CY 2009, 
CMS and the RUC identified a number of potentially misvalued codes each 
year using various identification screens, as discussed in section 
II.E. of this proposed rule. Historically, when we received RUC 
recommendations, our process had been to establish interim final RVUs 
for the potentially misvalued codes, new codes, and any other codes for 
which there were coding changes in the final rule with comment period 
for a year. Then, during the 60-day period following the publication of 
the final rule with comment period, we accepted public comment about 
those valuations. For services furnished during the calendar year 
following the publication of interim final rates, we paid for services 
based upon the interim final values established in the final rule. In 
the final rule with comment period for the subsequent year, we 
considered and responded to public comments received on the interim 
final values, and typically made any appropriate adjustments and 
finalized those values.
    In the CY 2015 PFS final rule with comment period, we finalized a 
new process for establishing values for new, revised and potentially 
misvalued codes. Under the new process, we include proposed values for 
these services in the proposed rule, rather than establishing them as 
interim final in the final rule with comment period. Beginning with the 
CY 2017 PFS proposed rule, the new process was applicable to all codes, 
except for new codes that describe truly new services. For CY 2017, we 
proposed new values in the CY 2017 PFS proposed rule for the vast 
majority of new, revised, and potentially misvalued codes for which we 
received complete RUC recommendations by February 10, 2016. To complete 
the transition to this new process, for codes for which we established 
interim final values in the CY 2016 PFS final rule with comment period, 
we reviewed the comments received during the 60-day public comment 
period following release of the

[[Page 35743]]

CY 2016 PFS final rule with comment period, and re-proposed values for 
those codes in the CY 2017 PFS proposed rule.
    We considered public comments received during the 60-day public 
comment period for the proposed rule before establishing final values 
in the CY 2017 PFS final rule. As part of our established process, we 
will adopt interim final values only in the case of wholly new services 
for which there are no predecessor codes or values and for which we do 
not receive recommendations in time to propose values. For CY 2017, we 
did not identify any new codes that described such wholly new services. 
Therefore, we did not establish any code values on an interim final 
basis.
    For CY 2018, we generally proposed the RUC-recommended work RVUs 
for new, revised, and potentially misvalued codes. We proposed these 
values based on our understanding that the RUC generally considers the 
kinds of concerns we historically raised regarding appropriate 
valuation of work RVUs. However, during our review of these recommended 
values, we identified some concerns similar to those we recognized in 
prior years. Given the relative nature of the PFS and our obligation to 
ensure that the RVUs reflect relative resource use, we included 
descriptions of potential alternative approaches we might have taken in 
developing work RVUs that differed from the RUC-recommended values. We 
sought comment on both the RUC-recommended values, as well as the 
alternatives considered. Several commenters generally supported the 
proposed use of the RUC-recommended work RVUs, without refinement. 
Other commenters expressed concern about the effect of the misvalued 
code reviews on particular specialties and settings and disappointment 
with our proposed approach for valuing codes for CY 2018. A detailed 
summary of the comments and our responses can be found in the CY 2018 
PFS final rule (82 FR 53033-53035).
    We clarified in response to commenters that we are not 
relinquishing our obligation to independently establish appropriate 
RVUs for services paid under the PFS. We will continue to thoroughly 
review and consider information we receive from the RUC, the Health 
Care Professionals Advisory Committee (HCPAC), public commenters, 
medical literature, Medicare claims data, comparative databases, 
comparison with other codes within the PFS, as well as consultation 
with other physicians and healthcare professionals within CMS and the 
federal government as part of our process for establishing valuations. 
While generally proposing the RUC-recommended work RVUs for new, 
revised, and potentially misvalued codes was our approach for CY 2018, 
we note that we also included alternative values where we believed 
there was a possible opportunity for increased precision. We also 
clarified that as part of our obligation to establish RVUs for the PFS, 
we annually make an independent assessment of the available 
recommendations, supporting documentation, and other available 
information from the RUC and other commenters to determine the 
appropriate valuations. Where we concur that the RUC's recommendations, 
or recommendations from other commenters, are reasonable and 
appropriate and are consistent with the time and intensity paradigm of 
physician work, we propose those values as recommended. Additionally, 
we will continue to engage with stakeholders, including the RUC, with 
regard to our approach for accurately valuing codes, and as we 
prioritize our obligation to value new, revised, and potentially 
misvalued codes. We continue to welcome feedback from all interested 
parties regarding valuation of services for consideration through our 
rulemaking process.
2. Methodology for Establishing Work RVUs
    For each code identified in this section, we conducted a review 
that included the current work RVU (if any), RUC-recommended work RVU, 
intensity, time to furnish the preservice, intraservice, and 
postservice activities, as well as other components of the service that 
contribute to the value. Our reviews of recommended work RVUs and time 
inputs generally included, but had not been limited to, a review of 
information provided by the RUC, the HCPAC, and other public 
commenters, medical literature, and comparative databases, as well as a 
comparison with other codes within the PFS, consultation with other 
physicians and health care professionals within CMS and the federal 
government, as well as Medicare claims data. We also assessed the 
methodology and data used to develop the recommendations submitted to 
us by the RUC and other public commenters and the rationale for the 
recommendations. In the CY 2011 PFS final rule with comment period (75 
FR 73328 through 73329), we discussed a variety of methodologies and 
approaches used to develop work RVUs, including survey data, building 
blocks, crosswalks to key reference or similar codes, and magnitude 
estimation (see the CY 2011 PFS final rule with comment period (75 FR 
73328 through 73329) for more information). When referring to a survey, 
unless otherwise noted, we mean the surveys conducted by specialty 
societies as part of the formal RUC process.
    Components that we used in the building block approach may have 
included preservice, intraservice, or postservice time and post-
procedure visits. When referring to a bundled CPT code, the building 
block components could include the CPT codes that make up the bundled 
code and the inputs associated with those codes. We used the building 
block methodology to construct, or deconstruct, the work RVU for a CPT 
code based on component pieces of the code. Magnitude estimation refers 
to a methodology for valuing work that determines the appropriate work 
RVU for a service by gauging the total amount of work for that service 
relative to the work for a similar service across the PFS without 
explicitly valuing the components of that work. In addition to these 
methodologies, we frequently utilized an incremental methodology in 
which we value a code based upon its incremental difference between 
another code and another family of codes. The statute specifically 
defines the work component as the resources in time and intensity 
required in furnishing the service. Also, the published literature on 
valuing work has recognized the key role of time in overall work. For 
particular codes, we refined the work RVUs in direct proportion to the 
changes in the best information regarding the time resources involved 
in furnishing particular services, either considering the total time or 
the intraservice time.
    Several years ago, to aid in the development of preservice time 
recommendations for new and revised CPT codes, the RUC created 
standardized preservice time packages. The packages include preservice 
evaluation time, preservice positioning time, and preservice scrub, 
dress and wait time. Currently, there are preservice time packages for 
services typically furnished in the facility setting (for example, 
preservice time packages reflecting the different combinations of 
straightforward or difficult procedure, and straightforward or 
difficult patient). Currently, there are three preservice time packages 
for services typically furnished in the nonfacility setting.
    We developed several standard building block methodologies to value 
services appropriately when they have common billing patterns. In cases 
where

[[Page 35744]]

a service is typically furnished to a beneficiary on the same day as an 
evaluation and management (E/M) service, we believe that there is 
overlap between the two services in some of the activities furnished 
during the preservice evaluation and postservice time. Our longstanding 
adjustments have reflected a broad assumption that at least one-third 
of the work time in both the preservice evaluation and postservice 
period is duplicative of work furnished during the E/M visit.
    Accordingly, in cases where we believed that the RUC has not 
adequately accounted for the overlapping activities in the recommended 
work RVU and/or times, we adjusted the work RVU and/or times to account 
for the overlap. The work RVU for a service is the product of the time 
involved in furnishing the service multiplied by the intensity of the 
work. Preservice evaluation time and postservice time both have a long-
established intensity of work per unit of time (IWPUT) of 0.0224, which 
means that 1 minute of preservice evaluation or postservice time 
equates to 0.0224 of a work RVU.
    Therefore, in many cases when we removed 2 minutes of preservice 
time and 2 minutes of postservice time from a procedure to account for 
the overlap with the same day E/M service, we also removed a work RVU 
of 0.09 (4 minutes x 0.0224 IWPUT) if we did not believe the overlap in 
time had already been accounted for in the work RVU. The RUC has 
recognized this valuation policy and, in many cases, now addresses the 
overlap in time and work when a service is typically furnished on the 
same day as an E/M service.
    The following paragraphs contain a general discussion of our 
approach to reviewing RUC recommendations and developing proposed 
values for specific codes. When they exist we also include a summary of 
stakeholder reactions to our approach. We note that many commenters and 
stakeholders have expressed concerns over the years with our ongoing 
adjustment of work RVUs based on changes in the best information we had 
regarding the time resources involved in furnishing individual 
services. We have been particularly concerned with the RUC's and 
various specialty societies' objections to our approach given the 
significance of their recommendations to our process for valuing 
services and since much of the information we used to make the 
adjustments is derived from their survey process. We are obligated 
under the statute to consider both time and intensity in establishing 
work RVUs for PFS services. As explained in the CY 2016 PFS final rule 
with comment period (80 FR 70933), we recognize that adjusting work 
RVUs for changes in time is not always a straightforward process, so we 
have applied various methodologies to identify several potential work 
values for individual codes.
    We have observed that for many codes reviewed by the RUC, 
recommended work RVUs have appeared to be incongruous with recommended 
assumptions regarding the resource costs in time. This has been the 
case for a significant portion of codes for which we recently 
established or proposed work RVUs that are based on refinements to the 
RUC-recommended values. When we have adjusted work RVUs to account for 
significant changes in time, we have started by looking at the change 
in the time in the context of the RUC-recommended work RVU. When the 
recommended work RVUs do not appear to account for significant changes 
in time, we have employed the different approaches to identify 
potential values that reconcile the recommended work RVUs with the 
recommended time values. Many of these methodologies, such as survey 
data, building block, crosswalks to key reference or similar codes, and 
magnitude estimation have long been used in developing work RVUs under 
the PFS. In addition to these, we sometimes used the relationship 
between the old time values and the new time values for particular 
services to identify alternative work RVUs based on changes in time 
components.
    In so doing, rather than ignoring the RUC-recommended value, we 
have used the recommended values as a starting reference and then 
applied one of these several methodologies to account for the 
reductions in time that we believe were not otherwise reflected in the 
RUC-recommended value. If we believed that such changes in time were 
already accounted for in the RUC's recommendation, then we did not made 
such adjustments. Likewise, we did not arbitrarily apply time ratios to 
current work RVUs to calculate proposed work RVUs. We used the ratios 
to identify potential work RVUs and considered these work RVUs as 
potential options relative to the values developed through other 
options.
    We do not imply that the decrease in time as reflected in survey 
values should always equate to a one-to-one or linear decrease in newly 
valued work RVUs. Instead, we have believed that, since the two 
components of work are time and intensity, absent an obvious or 
explicitly stated rationale for why the relative intensity of a given 
procedure has increased, significant decreases in time should be 
reflected in decreases to work RVUs. If the RUC's recommendation has 
appeared to disregard or dismiss the changes in time, without a 
persuasive explanation of why such a change should not be accounted for 
in the overall work of the service, then we have generally used one of 
the aforementioned methodologies to identify potential work RVUs, 
including the methodologies intended to account for the changes in the 
resources involved in furnishing the procedure.
    Several stakeholders, including the RUC, have expressed general 
objections to our use of these methodologies and deemed our actions in 
adjusting the recommended work RVUs as inappropriate; other 
stakeholders have also expressed general concerns with CMS refinements 
to RUC recommended values in general. In the CY 2017 PFS final rule (81 
FR 80272 through 80277) we responded in detail to several comments that 
we received regarding this issue. In the CY 2017 PFS proposed rule, we 
requested comments regarding potential alternatives to making 
adjustments that would recognize overall estimates of work in the 
context of changes in the resource of time for particular services; 
however, we did not receive any specific potential alternatives. As 
described earlier in this section, crosswalks to key reference or 
similar codes is one of the many methodological approaches we have 
employed to identify potential values that reconcile the RUC-recommend 
work RVUs with the recommended time values when the RUC-recommended 
work RVUs did not appear to account for significant changes in time.
    We look forward to continuing to engage with stakeholders and 
commenters, including the RUC, as we prioritize our obligation to value 
new, revised, and potentially misvalued codes, and will continue to 
welcome feedback from all interested parties regarding valuation of 
services for consideration through our rulemaking process. We refer 
readers to section II.H.4 of this proposed rule for a detailed 
discussion of the proposed valuation, and alternative valuation 
considered for specific codes. Table 13 contains a list of codes for 
which we propose work RVUs; this includes all codes for which we 
received RUC recommendations by February 10, 2018. The proposed work 
RVUs, work time and other payment information for all proposed CY 2019 
payable codes are available on the CMS website under downloads for the 
CY 2019 PFS proposed rule. Table 13 also contains

[[Page 35745]]

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

[[Page 35746]]

clinical labor tasks to avoid duplicative inputs and to reflect the 
resource costs of furnishing the typical service.
    We refer readers to section II.B. of this proposed rule for more 
information regarding the collaborative work of CMS and the RUC in 
improvements in standardizing clinical labor tasks.
(4) Recommended Items That Are Not Direct PE Inputs
    In some cases, the PE worksheets included with the RUC's 
recommendations include items that are not clinical labor, disposable 
supplies, or medical equipment or that cannot be allocated to 
individual services or patients. We addressed these kinds of 
recommendations in previous rulemaking (78 FR 74242), and we do not use 
items included in these recommendations as direct PE inputs in the 
calculation of PE RVUs.
(5) New Supply and Equipment Items
    The RUC generally recommends the use of supply and equipment items 
that already exist in the direct PE input database for new, revised, 
and potentially misvalued codes. Some recommendations, however, include 
supply or equipment items that are not currently in the direct PE input 
database. In these cases, the RUC has historically recommended that a 
new item be created and has facilitated our pricing of that item by 
working with the specialty societies to provide us copies of sales 
invoices. For CY 2019, we received invoices for several new supply and 
equipment items. Tables 15 and 16 detail the invoices received for new 
and existing items in the direct PE database. As discussed in section 
II.B. of this proposed rule, we encourage stakeholders to review the 
prices associated with these new and existing items to determine 
whether these prices appear to be accurate. Where prices appear 
inaccurate, we encourage stakeholders to submit invoices or other 
information to improve the accuracy of pricing for these items in the 
direct PE database during the 60-day public comment period for this 
proposed rule. We expect that invoices received outside of the public 
comment period would be submitted by February 10th of the following 
year for consideration in future rulemaking, similar to our new process 
for consideration of RUC recommendations.
    We remind stakeholders that due to the relativity inherent in the 
development of RVUs, reductions in existing prices for any items in the 
direct PE database increase the pool of direct PE RVUs available to all 
other PFS services. Tables 15 and 16 also include the number of 
invoices received and the number of nonfacility allowed services for 
procedures that use these equipment items. We provide the nonfacility 
allowed services so that stakeholders will note the impact the 
particular price might have on PE relativity, as well as to identify 
items that are used frequently, since we believe that stakeholders are 
more likely to have better pricing information for items used more 
frequently. A single invoice may not be reflective of typical costs and 
we encourage stakeholders to provide additional invoices so that we 
might identify and use accurate prices in the development of PE RVUs.
    In some cases, we do not use the price listed on the invoice that 
accompanies the recommendation because we identify publicly available 
alternative prices or information that suggests a different price is 
more accurate. In these cases, we include this in the discussion of 
these codes. In other cases, we cannot adequately price a newly 
recommended item due to inadequate information. Sometimes, no 
supporting information regarding the price of the item has been 
included in the recommendation. In other cases, the supporting 
information does not demonstrate that the item has been purchased at 
the listed price (for example, vendor price quotes instead of paid 
invoices). In cases where the information provided on the item allows 
us to identify clinically appropriate proxy items, we might use 
existing items as proxies for the newly recommended items. In other 
cases, we included the item in the direct PE input database without any 
associated price. Although including the item without an associated 
price means that the item does not contribute to the calculation of the 
proposed PE RVU for particular services, it facilitates our ability to 
incorporate a price once we obtain information and are able to do so.
(6) Service Period Clinical Labor Time in the Facility Setting
    Generally speaking, our proposed inputs do not include clinical 
labor minutes assigned to the service period because the cost of 
clinical labor during the service period for a procedure in the 
facility setting is not considered a resource cost to the practitioner 
since Medicare makes separate payment to the facility for these costs. 
We address proposed code-specific refinements to clinical labor in the 
individual code sections.
(7) Procedures Subject to the Multiple Procedure Payment Reduction 
(MPPR) and the OPPS Cap
    We note that the public use files for the PFS proposed and final 
rules for each year display both the services subject to the MPPR lists 
on diagnostic cardiovascular services, diagnostic imaging services, 
diagnostic ophthalmology services, and therapy services. We also 
include a list of procedures that meet the definition of imaging under 
section 1848(b)(4)(B) of the Act, and therefore, are subject to the 
OPPS cap for the upcoming calendar year. The public use files for CY 
2019 are available on the CMS website under downloads for the CY 2019 
PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. 
For more information regarding the history of the MPPR policy, we refer 
readers to the CY 2014 PFS final rule with comment period (78 FR 74261-
74263). For more information regarding the history of the OPPS cap, we 
refer readers to the CY 2007 PFS final rule with comment period (71 FR 
69659-69662).
4. Proposed Valuation of Specific Codes for CY 2019
(1) Fine Needle Aspiration (CPT Codes 10021, 10X11, 10X12, 10X13, 
10X14, 10X15, 10X16, 10X17, 10X18, 10X19, 76492, 77002 and 77021)
    CPT code 10021 was identified as part of the OPPS cap payment 
proposal in CY 2014 (78 FR 74246-74248), and it was reviewed by the RUC 
for direct PE inputs only as part of the CY 2016 rule cycle. 
Afterwards, CPT codes 10021 and 10022 were referred to the CPT 
Editorial Panel to consider adding additional clarifying language to 
the code descriptors and to include bundled imaging guidance due to the 
fact that imaging had become typical with these services. In June 2017, 
the CPT Editorial Panel deleted CPT code 10022, revised CPT code 10021, 
and created nine new codes to describe fine needle aspiration 
procedures with and without imaging guidance. These ten codes were 
surveyed and reviewed for the October 2017 and January 2018 RUC 
meetings. Several imaging services were also reviewed along with the 
rest of the code family, although only CPT code 77021 was subject to a 
new survey.
    For CY 2019, we are proposing the RUC-recommended work RVU for 
seven of the ten codes in this family. Specifically, we are proposing a 
work RVU of 0.80 for CPT code 10X11 (Fine needle aspiration biopsy; 
without

[[Page 35747]]

imaging guidance; each additional lesion), a work RVU of 1.00 for CPT 
code 10X13 (Fine needle aspiration biopsy, including ultrasound 
guidance; each additional lesion), a work RVU of 1.81 for CPT code 
10X14 (Fine needle aspiration biopsy, including fluoroscopic guidance; 
first lesion), a work RVU of 1.18 for CPT code 10X15 (Fine needle 
aspiration biopsy, including fluoroscopic guidance; each additional 
lesion), and a work RVU of 1.65 for CPT code 10X17 (Fine needle 
aspiration biopsy, including CT guidance; each additional lesion). We 
are also proposing to assign the recommended contractor-priced status 
to CPT codes 10X18 (Fine needle aspiration biopsy, including MR 
guidance; first lesion) and 10X19 (Fine needle aspiration biopsy, 
including MR guidance; each additional lesion) due to low utilization 
until these services are more widely utilized. In addition, we are 
proposing the recommended work RVU of 1.50 for CPT code 77021 (Magnetic 
resonance guidance for needle placement (e.g., for biopsy, fine needle 
aspiration biopsy, injection, or placement of localization device) 
radiological supervision and interpretation), as well as proposing to 
reaffirm the current work RVUs of 0.67 for CPT code 76942 (Ultrasonic 
guidance for needle placement (e.g., biopsy, fine needle aspiration 
biopsy, injection, localization device), imaging supervision and 
interpretation) and 0.54 for 77002 (Fluoroscopic guidance for needle 
placement (e.g., biopsy, fine needle aspiration biopsy, injection, 
localization device)).
    We disagree with the RUC-recommended work RVU of 1.20 for CPT code 
10021 (Fine needle aspiration biopsy; without imaging guidance; first 
lesion) and are proposing a work RVU of 1.03 based on a direct 
crosswalk to CPT code 36440 (Push transfusion, blood, 2 years or 
younger). CPT code 36440 is a recently reviewed code with the same 
intraservice time of 15 minutes and 2 additional minutes of total time. 
In reviewing CPT code 10021, we noted that the recommended intraservice 
time is decreasing from 17 minutes to 15 minutes (12 percent 
reduction), and the recommended total time is decreasing from 48 
minutes to 33 minutes (32 percent reduction); however, the RUC-
recommended work RVU is only decreasing from 1.27 to 1.20, which is a 
reduction of just over 5 percent. Although we do not imply that the 
decrease in time as reflected in survey values must equate to a one-to-
one or linear decrease in the valuation of work RVUs, we believe that 
since the two components of work are time and intensity, significant 
decreases in time should be appropriately reflected in decreases to 
work RVUs. In the case of CPT code 10021, we believe that it would be 
more accurate to propose a work RVU of 1.03 based on a crosswalk to CPT 
code 36440 to account for these decreases in the surveyed work time.
    We disagree with the RUC-recommended work RVU of 1.63 for CPT code 
10X12 (Fine needle aspiration biopsy, including ultrasound guidance; 
first lesion) and are proposing a work RVU of 1.46. Although we 
disagree with the RUC-recommended work RVU, we concur that the relative 
difference in work between CPT codes 10021 and 10X12 is equivalent to 
the recommended interval of 0.43 RVUs. Therefore, we are proposing a 
work RVU of 1.46 for CPT code 10X12, based on the recommended interval 
of 0.43 additional RVUs above our proposed work RVU of 1.03 for CPT 
code 10021. The proposed increment of 0.43 RVUs above CPT code 10021 is 
also based on the use of two crosswalk codes: CPT code 99225 
(Subsequent observation care, per day, for the evaluation and 
management of a patient, which requires at least 2 of 3 key 
components); and CPT code 99232 (Subsequent hospital care, per day, for 
the evaluation and management of a patient, which requires at least 2 
of 3 key components). Both of these codes have the same intraservice 
time and 1 additional minute of total time as compared with CPT code 
10X12, and both crosswalk codes share a work RVU of 1.39.
    We disagree with the RUC-recommended work RVU of 2.43 for CPT code 
10X16 (Fine needle aspiration biopsy, including CT guidance; first 
lesion) and we are proposing a work RVU of 2.26. Although we disagree 
with the RUC-recommended work RVU, we concur that the relative 
difference in work between CPT codes 10021 and 10X16 is equivalent to 
the recommended interval of 1.23 RVUs. Therefore, we are proposing a 
work RVU of 2.26 for CPT code 10X16, based on the recommended interval 
of 1.23 additional RVUs above our proposed work RVU of 1.03 for CPT 
code 10021. The proposed use of the recommended increment from CPT code 
10021 is also based on the use of a crosswalk to CPT code 74263 
(Computed tomographic (CT) colonography, screening, including image 
postprocessing), another CT procedure with 38 minutes of intraservice 
time and 50 minutes of total time at a work RVU of 2.28.
    We note that the recommended work pool is increasing by 
approximately 20 percent for the Fine Needle Aspiration family as a 
whole, while the recommended work time pool for the same codes is only 
increasing by about 2 percent. Since time is defined as one of the two 
components of work, we believe that this indicates a discrepancy in the 
recommended work values. We do not believe that the recoding of the 
services in this family has resulted in an increase in their intensity, 
only a change in the way in which they will be reported, and therefore, 
we do not believe that it would serve the interests of relativity to 
propose the recommended work values for all of the codes in this 
family. We believe that, generally speaking, the recoding of a family 
of services should maintain the same total work pool, as the services 
themselves are not changing, only the coding structure under which they 
are being reported. We also note that through the bundling of some of 
these frequently reported services, it is reasonable to expect that the 
new coding system will achieve savings via elimination of duplicative 
assumptions of the resources involved in furnishing particular 
servicers. For example, a practitioner would not be carrying out the 
full preservice work twice for CPT codes 10022 and 76942, but 
preservice times were assigned to both of the codes under the old 
coding. We believe the new coding assigns more accurate work times and 
thus reflects efficiencies in resource costs that existed regardless of 
how the services were previously reported.
    For the direct PE inputs, we are proposing to refine the clinical 
labor time for the ``Prepare room, equipment and supplies'' (CA013) 
activity to 3 minutes and to refine the clinical labor time for the 
``Confirm order, protocol exam'' (CA014) activity to 0 minutes for CPT 
code 77021. This code did not previously have clinical labor time 
assigned for the ``Confirm order, protocol exam'' clinical labor task, 
and we do not have any reason to believe that the services being 
furnished by the clinical staff have changed, only the way in which 
this clinical labor time has been presented on the PE worksheets. We 
also note that there is no effect on the total clinical labor direct 
costs in these situations, since the same 3 minutes of clinical labor 
time is still being furnished. We are also proposing to refine the 
equipment times in accordance with our standard equipment time 
formulas.
(2) Biopsy of Nail (CPT Code 11755)
    CPT code 11755 (Biopsy of nail unit (e.g., plate, bed, matrix, 
hyponychium, proximal and lateral nail folds) (separate procedure)) was 
identified as potentially

[[Page 35748]]

misvalued on a screen of 0-day global services reported with an E/M 
visit 50 percent of the time or more, on the same day of service by the 
same patient and the same practitioner, that have not been reviewed in 
the last 5 years with Medicare utilization greater than 20,000. For CY 
2019, the HCPAC recommended a work RVU of 1.25 based on the survey 
median value.
    We disagree with the recommended value and are proposing a work RVU 
of 1.08 for CPT code 11755 based on the survey 25th percentile value. 
We note that the recommended intraservice time for CPT code 11755 is 
decreasing from 25 minutes to 15 minutes (40 percent reduction), and 
the recommended total time for CPT code 11755 is decreasing from 55 
minutes to 39 minutes (29 percent reduction); however, the recommended 
work RVU is only decreasing from 1.31 to 1.25, which is a reduction of 
less than 5 percent. Although we do not imply that the decrease in time 
as reflected in survey values must equate to a one-to-one or linear 
decrease in the valuation of work RVUs, we believe that since the two 
components of work are time and intensity, significant decreases in 
time should be reflected in decreases to work RVUs. In the case of CPT 
code 11755, we believe that it would be more accurate to propose the 
survey 25th percentile work RVU than the survey median to account for 
these decreases in the surveyed work time.
    The proposed work RVU of 1.08 is also based on a crosswalk to CPT 
code 11042 (Debridement, subcutaneous tissue (includes epidermis and 
dermis, if performed); first 20 sq cm or less), which has a work RVU of 
1.01, the same intraservice time of 15 minutes, and a similar total 
time of 36 minutes. We also note that, generally speaking, working with 
extremities like nails tends to be less intensive in clinical terms 
than other services, especially as compared to surgical procedures. We 
believe that this further supports our proposal of a work RVU of 1.08 
for CPT code 11755.
    We are proposing to refine the equipment times in accordance with 
our standard equipment time formulas.
(3) Skin Biopsy (CPT Codes 11X02, 11X03, 11X04, 11X05, 11X06, and 
11X07)
    In CY 2016, CPT codes 11100 (Biopsy of skin, subcutaneous tissue 
and/or mucous membrane (including simple closure), unless otherwise 
listed; single lesion) and 11101 (Biopsy of skin, subcutaneous tissue 
and/or mucous membrane (including simple closure), unless otherwise 
listed; each separate/additional lesion) were identified as potentially 
misvalued using a high expenditure services screen across specialties 
with Medicare allowed charges of $10 million or more. Prior to the 
January 2016 RUC meeting, the specialty society notified the RUC that 
its survey data displayed a bimodal distribution of responses with more 
outliers than usual. The RUC referred CPT codes 11100 and 11101 to the 
CPT Editorial Panel. In February 2017, the CPT Editorial Panel deleted 
these two codes and created six new codes for primary and additional 
biopsy based on the thickness of the sample and the technique utilized.
    For CY 2019, we are proposing the RUC-recommended work RVUs for 
five of the six codes in the family. We are proposing a work RVU of 
0.66 for CPT code 11X02 (Tangential biopsy of skin, (e.g., shave, 
scoop, saucerize, curette), single lesion), a work RVU of 0.83 for CPT 
code 11X04 (Punch biopsy of skin, (including simple closure when 
performed), single lesion), a work RVU of 0.45 for CPT code 11X05 
(Punch biopsy of skin, (including simple closure when performed), each 
separate/additional lesion), a work RVU of 1.01 for CPT code 11X06 
(Incisional biopsy of skin (e.g., wedge), (including simple closure 
when performed), single lesion), and a work RVU of 0.54 for CPT code 
11X07 (Incisional biopsy of skin (e.g., wedge), (including simple 
closure when performed), each separate/additional lesion).
    For CPT code 11X03 (Tangential biopsy of skin, (e.g., shave, scoop, 
saucerize, curette), each separate/additional lesion), we disagree with 
the RUC-recommended work RVU of 0.38 and are proposing a work RVU of 
0.29. When we compared the RUC-recommended work RVU of 0.38 to other 
add-on codes in the RUC database, we found that CPT code 11X03 would 
have the second-highest work RVU for any code with 7 minutes or less of 
total time, with the recommended work RVU noticeably higher than other 
related add-on codes, and we did not agree that the tangential biopsy 
service being performed should have an anomalously high work value in 
comparison to other similar add-on codes. Our proposed work RVU of 0.29 
is based on a crosswalk to CPT code 11201 (Removal of skin tags, 
multiple fibrocutaneous tags, any area; each additional 10 lesions, or 
part thereof), a clinically related add-on procedure with 5 minutes of 
intraservice and total time as opposed to the surveyed 6 minutes for 
CPT code 11X03. We also noted that the intraservice time ratio between 
CPT code 11X03 and the recommended reference code, CPT code 11732 
(Avulsion of nail plate, partial or complete, simple; each additional 
nail plate), was 75 percent (6 minutes divided by 8 minutes). This 75 
percent ratio when applied to the work RVU of CPT code 11732 also 
produced a work RVU of 0.29 (0.38 * 0.75 = 0.29). Finally, we are also 
supporting the proposed work RVU through a crosswalk to CPT code 33508 
(Endoscopy, surgical, including video-assisted harvest of vein(s) for 
coronary artery bypass procedure), which has a higher intraservice time 
of 10 minutes but a similar work RVU of 0.31. We believe that our 
proposed work RVU of 0.29 for CPT code 11X03 better serves the 
interests of relativity, as well as better fitting with the other 
recommended work RVUs within this family of codes.
    For the direct PE inputs, we are proposing to remove the 2 minutes 
of clinical labor time for the ``Review home care instructions, 
coordinate visits/prescriptions'' (CA035) activity for CPT codes 11X02, 
11X04, and 11X06. These codes are typically billed with a same day E/M 
service, and we believe that it would be duplicative to assign clinical 
labor time for reviewing home care instructions given that this task 
would typically be done during the same day E/M service. We are also 
proposing to refine the equipment times in accordance with our standard 
equipment time formulas.
    We are proposing to refine the quantity of the ``gown, staff, 
impervious'' (SB024) and the ``mask, surgical, with face shield'' 
(SB034) supplies from 2 to 1 for CPT codes 11X02, 11X04, and 11X06. We 
are proposing to remove one gown and one surgical mask from these codes 
as duplicative since these supplies are also included within the 
surgical instrument cleaning pack (SA043). We are also proposing to 
remove all of the supplies in the three add-on procedures (CPT codes 
11X03, 11X05, and 11X07) that were not contained in the previous add-on 
procedure for this family, CPT code 11101. We do not believe that the 
use of these supplies would be typical for the ``each additional 
lesion'' add-on codes, as these supplies are all included in the base 
codes and are not currently utilized in CPT code 11101. We note that 
the recommended direct PE costs for the three new add-on codes 
represent an increase of approximately 500 percent from the direct PE 
costs for CPT code 11101, and believe that this is largely due to the 
addition of these new supplies.

[[Page 35749]]

(4) Injection Tendon Origin-Insertion (CPT Code 20551)
    CPT code 20551 (Injection(s); single tendon origin/insertion) was 
identified as potentially misvalued on a screen of 0-day global 
services reported with an E/M visit 50 percent of the time or more, on 
the same day of service by the same patient and the same practitioner, 
that have not been reviewed in the last 5 years with Medicare 
utilization greater than 20,000. For CY 2019, we are proposing the RUC-
recommended work RVU of 0.75 for CPT code 20551.
    We are proposing to maintain the current work RVU for many of the 
CPT codes identified as potentially misvalued on the screen of 0-day 
global services reported with an E/M visit 50 percent of the time or 
more. We note that regardless of the proposed work valuations for 
individual codes, which may or may not retain the same work RVU, we 
continue to have reservations about the valuation of 0-day global 
services that are typically billed with a separate E/M service with the 
use of Modifier 25 (indicating that a significant and separately 
identifiable E/M service was provided on the same day). As we stated in 
the CY 2017 PFS final rule (81 FR 80204), we continue to believe that 
the routine billing of separate E/M services in conjunction with a 
particular code may indicate a possible problem with the valuation of 
the code bundle, which is intended to include all the routine care 
associated with the service. We will continue to consider additional 
ways to address the appropriate valuation for these services.
    For the direct PE inputs, we are proposing to remove the clinical 
labor time for the ``Provide education/obtain consent'' (CA011) and the 
``Review home care instructions, coordinate visits/prescriptions'' 
(CA035) activities for CPT code 20551. This code is typically billed 
with a same day E/M service, and we believe that it would be 
duplicative to assign clinical labor time for obtaining consent or 
reviewing home care instructions given that these tasks would typically 
be done during the same day E/M service. We are also proposing to 
refine the equipment times in accordance with our standard equipment 
time formulas.
(5) Structural Allograft (CPT Codes 209X3, 209X4, and 209X5)
    In February 2017, the CPT Editorial Panel created three new codes 
to describe allografts. These codes were designated as add-on codes and 
revised to more accurately describe the structural allograft procedures 
they represent. For CY 2019, we are proposing the RUC-recommended work 
RVUs for all three codes. We are proposing a work RVU of 13.01 for CPT 
code 209X3 (Allograft, includes templating, cutting, placement and 
internal fixation when performed; osteoarticular, including articular 
surface and contiguous bone), a work RVU of 11.94 for CPT code 209X4 
(Allograft, includes templating, cutting, placement and internal 
fixation when performed; hemicortical intercalary, partial (i.e., 
hemicylindrical)), and a work RVU of 13.00 for CPT code 209X5 
(Allograft, includes templating, cutting, placement and internal 
fixation when performed; intercalary, complete (i.e., cylindrical)).
    These three new codes are all facility-only procedures with no 
recommended direct PE inputs.
(6) Knee Arthrography Injection (CPT Code 27X69)
    CPT code 27370 (Injection of contrast for knee arthrography) 
repeatedly appeared on high volume growth screens between 2008 and 
2016, and the RUC expressed concern that the high volume growth for 
this procedure was likely due to its being reported incorrectly as 
arthrocentesis or aspiration. In June 2017, the CPT Editorial Panel 
deleted CPT code 27370 and replaced it with a new code, 27X69, to 
report injection procedure for knee arthrography or enhanced CT/MRI 
knee arthrography.
    The RUC recommended a work RVU for CPT code 27X69 of 0.96, which is 
identical to the work RVU for CPT code 27370 (Injection of contrast for 
knee arthrography). The RUC's recommendation is based on key reference 
service, CPT code 23350 (Injection procedure for shoulder arthrography 
or enhanced CT/MRI shoulder arthrography), with identical intraservice 
time (15 minutes) and total time (28 minutes) as the new CPT code and a 
work RVU of 1.00. The RUC notes that its recommendation is lower than 
the 25th percentile from the survey results, but that the work 
described by the service should be valued identically with the CPT code 
being replaced. We disagree with the RUC's recommended work RVU for CPT 
code 27X69. Both the total (28 minutes) and intraservice (15 minutes) 
times for the new CPT code are considerably lower than the deleted CPT 
code 27370. Based on the reduced times and the projected work RVU from 
the reverse building block methodology (0.60 work RVUs), we believe 
this CPT code should be valued at 0.77 work RVUs, supported by a 
crosswalk to CPT code 29075 (Application, cast; elbow to finger (short 
arm)), with total time of 27 minutes and intraservice time of 15 
minutes. Therefore, we are proposing a work RVU of 0.77 for CPT code 
27X69.
    For the direct PE inputs, we are proposing to refine the clinical 
labor time for the ``Prepare room, equipment and supplies'' (CA013) 
activity to 3 minutes and to refine the clinical labor time for the 
``Confirm order, protocol exam'' (CA014) activity to 0 minutes. The 
predecessor code for 27X69, CPT code 27370, did not previously have 
clinical labor time assigned for the ``Confirm order, protocol exam'' 
clinical labor task, and we do not have any reason to believe that the 
services being furnished by the clinical staff have changed, only the 
way in which this clinical labor time has been presented on the PE 
worksheets. We also note that there is no effect on the total clinical 
labor direct costs in these situations, since the same 3 minutes of 
clinical labor time is still being furnished.
    We are proposing to remove the clinical labor time for the ``Scan 
exam documents into PACS. Complete exam in RIS system to populate 
images into work queue'' (CA032) activity. CPT code 27X69 does not 
include a PACS workstation among the recommended equipment, and the 
predecessor code 27370 did not previously include time for this 
clinical labor activity. We believe that data entry activities such as 
this task would be classified as indirect PE, as they are considered 
administrative activities and are not individually allocable to a 
particular patient for a particular service. We are also proposing to 
refine the equipment times in accordance with our standard equipment 
time formulas.
(7) Application of Long Arm Splint (CPT Code 29105)
    CPT code 29105 (Application of long arm splint (shoulder to hand)) 
was identified as potentially misvalued on a screen of 0-day global 
services reported with an E/M visit 50 percent of the time or more, on 
the same day of service by the same patient and the same practitioner, 
that have not been reviewed in the last 5 years with Medicare 
utilization greater than 20,000. For CY 2019, we are proposing the RUC-
recommended work RVU of 0.80 for CPT code 29105.
    For the direct PE inputs, we are proposing to refine the equipment 
times in accordance with our standard equipment time formulas.
(8) Strapping Lower Extremity (CPT Codes 29540 and 29550)
    CPT codes 29540 (Strapping; ankle and/or foot) and 29550 
(Strapping; toes) were identified as potentially misvalued

[[Page 35750]]

on a screen of 0-day global services reported with an E/M visit 50 
percent of the time or more, on the same day of service by the same 
patient and the same practitioner, that have not been reviewed in the 
last 5 years with Medicare utilization greater than 20,000. For CY 
2019, we are proposing the HCPAC-recommended work RVU of 0.39 for CPT 
code 29540 and the HCPAC-recommended work RVU of 0.25 for CPT code 
29550.
    For the direct PE inputs, we are proposing to refine the clinical 
labor time for the ``Provide education/obtain consent'' (CA011) 
activity from 3 minutes to 2 minutes for both codes, as this is the 
standard clinical labor time assigned for patient education and 
consent. We are also proposing to remove the 2 minutes of clinical 
labor time for the ``Review home care instructions, coordinate visits/
prescriptions'' (CA035) activity for both codes. CPT codes 29540 and 
29550 are both typically billed with a same day E/M service, and we 
believe that it would be duplicative to assign clinical labor time for 
reviewing home care instructions given that this task would typically 
be done during the same day E/M service. We are also proposing to 
refine the equipment times in accordance with our standard equipment 
time formulas.
(9) Bronchoscopy (CPT Codes 31623 and 31624)
    CPT code 31623 (Bronchoscopy, rigid or flexible, including 
fluoroscopic guidance, when performed; with brushing or protected 
brushings) was identified on a high growth screen of services with 
total Medicare utilization of 10,000 or more that have increased by at 
least 100 percent from 2009 through 2014. CPT code 31624 (Bronchoscopy, 
rigid or flexible, including fluoroscopic guidance, when performed; 
with bronchial alveolar lavage) was also included for review as part of 
the same family of codes. For CY 2019, we are proposing the RUC-
recommended work RVU of 2.63 for CPT codes 31623 and 31624.
    For the direct PE inputs, we are proposing to refine the clinical 
labor time for the ``Complete post-procedure diagnostic forms, lab and 
x-ray requisitions'' (CA027) activity from 4 minutes to 2 minutes for 
CPT codes 31623 and 31624. Two minutes is the standard time, as well as 
the current time for this clinical labor activity, and we have no 
reason to believe that the time to perform this task has increased 
since the codes were last reviewed. We did not receive any explanation 
in the recommendations as to why the time for this activity would be 
doubling over the current values. We are also proposing to refine the 
equipment times in accordance with our standard equipment time 
formulas.
(10) Pulmonary Wireless Pressure Sensor Services (CPT Codes 332X0 and 
93XX1)
    In September 2017, the CPT Editorial Panel created a code to 
describe pulmonary wireless sensor implantation and another code for 
remote care management of patients with an implantable, wireless 
pulmonary artery pressure sensor monitor. For CY 2019, we are proposing 
the RUC-recommended work RVU of 6.00 for CPT code 332X0 (Transcatheter 
implantation of wireless pulmonary artery pressure sensor for long term 
hemodynamic monitoring, including deployment and calibration of the 
sensor, right heart catheterization, selective pulmonary 
catheterization, radiological supervision and interpretation, and 
pulmonary artery angiography, when performed), and the RUC-recommended 
work RVU of 0.70 for CPT code 93XX1 (Remote monitoring of a wireless 
pulmonary artery pressure sensor for up to 30 days including at least 
weekly downloads of pulmonary artery pressure recordings, 
interpretation(s), trend analysis, and report(s) by a physician or 
other qualified health care professional).
    We are not proposing any direct PE refinements for this code 
family.
(11) Cardiac Event Recorder Procedures (CPT Codes 332X5 and 332X6)
    In February 2017, the CPT Editorial Panel created two new codes 
replacing cardiac event recorder codes to reflect new technology. For 
CY 2019, we are proposing the RUC-recommended work RVU of 1.53 for CPT 
code 332X5 (Insertion, subcutaneous cardiac rhythm monitor, including 
programming) and the RUC-recommended work RVU of 1.50 for CPT code 
332X6 (Removal, subcutaneous cardiac rhythm monitor).
    We are not proposing any direct PE refinements for this code 
family.
(12) Aortoventriculoplasty With Pulmonary Autograft (CPT Code 335X1)
    In September 2017, the CPT Editorial Panel created one new code to 
combine the efforts of aortic valve and root replacement with 
subvalvular left ventricular outflow tract enlargement to allow for an 
unobstructed left ventricular outflow tract.
    For CY 2019, we are proposing the RUC-recommended work RVU of 64.00 
for CPT code 335X1 (Replacement, aortic valve; by translocation of 
autologous pulmonary valve and transventricular aortic annulus 
enlargement of the left ventricular outflow tract with valved conduit 
replacement of pulmonary valve (Ross-Konno procedure)). When this code 
is re-reviewed in a few years as part of the new technology screen, we 
look forward to receiving new recommendations on the whole family, 
including the related Ross and Konno procedures (CPT codes 33413 and 
33412 respectively) that were used as references for CPT code 335X1.
    For the direct PE inputs, we are proposing to refine the preservice 
clinical labor times to match our standards for 90-day global 
procedures. We are proposing to refine the clinical labor time for the 
``Coordinate pre-surgery services (including test results)'' (CA002) 
activity from 25 minutes to 20 minutes, to refine the clinical labor 
time for the ``Schedule space and equipment in facility'' (CA003) 
activity from 12 minutes to 8 minutes, and to refine the clinical labor 
time for the ``Provide pre-service education/obtain consent'' (CA004) 
activity from 26 minutes to 20 minutes. We are also proposing to add 15 
minutes of clinical labor time for the ``Perform regulatory mandated 
quality assurance activity (pre-service)'' (CA008) activity. We agree 
with the recommendation that the total preservice clinical labor time 
for CPT code 335X1 is unchanged from the two reference codes at 75 
minutes. However, we believe that the clinical labor associated with 
additional coordination between multiple specialties prior to patient 
arrival is more accurately described through the use of the CA008 
activity code than by distributing this 15 minutes amongst the other 
preservice clinical labor activities. We previously established 
standard preservice times for 90-day global procedures, and did not 
want to propose clinical labor times above those standards for CPT code 
335X1. We also note that there is no effect on the total clinical labor 
direct costs in this situation, since the same 15 minutes of preservice 
clinical labor time is still being furnished.
(13) Hemi-Aortic Arch Replacement (CPT Code 33X01)
    At the September 2017 CPT Editorial Panel meeting, the Panel 
created one new add-on code to report hemi-aortic arch graft 
replacement. For CY 2019, we are proposing the RUC-recommended work RVU 
of 19.74 for CPT code 33X01 (Aortic hemiarch graft including isolation 
and control of the arch vessels, beveled open distal aortic anastomosis 
extending under one or more of the arch vessels, and total circulatory 
arrest or isolated cerebral perfusion). CPT code

[[Page 35751]]

33X01 is a facility-only procedure with no recommended direct PE 
inputs.
(14) Leadless Pacemaker Procedures (CPT Codes 33X05 and 33X06)
    At the September 2017 CPT Editorial Panel meeting, the Panel 
replaced the five leadless pacemaker services Category III codes with 
the addition of two new CPT codes to report transcatheter leadless 
pacemaker procedures and revised five codes to include evaluation and 
interrogation services of leadless pacemaker systems.
    For CPT code 33X05 (Transcatheter insertion or replacement of 
permanent leadless pacemaker, right ventricular, including imaging 
guidance (e.g., fluoroscopy, venous ultrasound, ventriculography, 
femoral venography) and device evaluation (e.g., interrogation or 
programming), when performed), we disagree with the recommended work 
RVU of 8.77 and we are proposing a work RVU of 7.80 based on a direct 
crosswalk to one of the top reference codes selected by the RUC survey 
participants, CPT code 33207 (Insertion of new or replacement of 
permanent pacemaker with transvenous electrode(s); ventricular). This 
code has the same 60 minutes of intraservice time as CPT code 33X05 and 
an additional 61 minutes of total time at a work RVU of 7.80. In our 
review of CPT code 33X05, we noted that this reference code had an 
additional inpatient hospital visit of CPT code 99232 (Subsequent 
hospital care, per day, for the evaluation and management of a patient, 
which requires at least 2 of 3 key components) and a full instead of a 
half discharge visit of CPT code 99238 (Hospital discharge day 
management; 30 minutes or less) included in its 90-day global period. 
The combined work RVU of these two visits would be equal to 2.03. 
However, the recommended work RVU for CPT code 33X05 was 0.97 work RVUs 
higher than CPT code 33207, despite having fewer of these visits and 
significantly less surveyed total time. While we acknowledge that CPT 
code 33X05 is a more intense procedure than CPT code 33207, we do not 
believe that it should be valued almost a full RVU higher than the 
reference code given the fewer visits in the global period and the 
lower surveyed work time.
    Therefore, we are proposing to crosswalk CPT code 33X05 to CPT code 
33207 at the same work RVU of 7.80. The proposed work RVU is also 
supported through a reference crosswalk to CPT code 38542 (Dissection, 
deep jugular node(s)), which has 60 minutes of intraservice time, 198 
minutes of total time, and a work RVU of 7.95. We believe that our 
proposed work RVU of 7.80 is a more accurate valuation for CPT code 
33X05, while still recognizing the greater intensity of this procedure 
in comparison to its reference code.
    For CPT code 33X06 (Transcatheter removal of permanent leadless 
pacemaker, right ventricular), we disagree with the RUC-recommended 
work RVU of 9.56 and we are proposing a work RVU of 8.59. Although we 
disagree with the RUC-recommended work RVU, we concur that the relative 
difference in work between CPT codes 33X05 and 33X06 is equivalent to 
the recommended interval of 0.79 RVUs. Therefore, we are proposing a 
work RVU of 8.59 for CPT code 33X06, based on the recommended interval 
of 0.79 additional RVUs above our proposed work RVU of 7.80 for CPT 
code 33X05. We also note that our proposed work RVU for CPT code 33X06 
situates it approximately halfway between the two reference codes from 
the survey, with CPT code 33270 (Insertion or replacement of permanent 
subcutaneous implantable defibrillator system, with subcutaneous 
electrode, including defibrillation threshold evaluation, induction of 
arrhythmia, evaluation of sensing for arrhythmia termination, and 
programming or reprogramming of sensing or therapeutic parameters, when 
performed) having an intraservice time of 90 minutes and a work RVU of 
9.10, and CPT code 33207 having an intraservice time of 60 minutes and 
a work RVU of 7.80. CPT code 33X06 has a surveyed intraservice time of 
75 minutes and nearly splits the difference between them at our 
proposed work RVU of 8.59.
    We are not proposing any direct PE refinements for this code 
family.
(15) PICC Line Procedures (CPT Codes 36568, 36569, 36X72, 36X73, and 
36584)
    In CY 2016, CPT code 36569 (Insertion of peripherally inserted 
central venous catheter (PICC), without subcutaneous port or pump, 
without imaging guidance; age 5 years or older) was identified as 
potentially misvalued using a high expenditure services screen across 
specialties with Medicare allowed charges of $10 million or more. CPT 
code 36569 is typically reported with CPT codes 76937 (Ultrasound 
guidance for vascular access requiring ultrasound evaluation of 
potential access sites, documentation of selected vessel patency, 
concurrent realtime ultrasound visualization of vascular needle entry, 
with permanent recording and reporting) and 77001 (Fluoroscopic 
guidance for central venous access device placement, replacement 
(catheter only or complete), or removal) and was referred to the CPT 
Editorial Panel to have the two common imaging codes bundled into the 
code. In September 2017, the CPT Editorial Panel revised CPT codes 
36568 (Insertion of peripherally inserted central venous catheter 
(PICC), without subcutaneous port or pump; younger than 5 years of 
age), 36569 and 36584 (Replacement, complete, of a peripherally 
inserted central venous catheter (PICC), without subcutaneous port or 
pump, through same venous access, including all imaging guidance, image 
documentation, and all associated radiological supervision and 
interpretation required to perform the replacement) and created two new 
CPT codes to specify the insertion of peripherally inserted central 
venous catheter (PICC), without subcutaneous port or pump, including 
all imaging guidance, image documentation, and all associated 
radiological supervision and interpretation required to perform the 
insertion.
    For CY 2019, we are proposing the RUC-recommended work RVU for two 
of the CPT codes in the family. We are proposing the RUC-recommended 
work RVU of 2.11 for CPT code 36568 and the RUC-recommended work RVU of 
1.90 for CPT code 36569.
    For CPT code 36X72 (Insertion of peripherally inserted central 
venous catheter (PICC), without subcutaneous port or pump, including 
all imaging guidance, image documentation, and all associated 
radiological supervision and interpretation required to perform the 
insertion; younger than 5 years of age), we disagree with the RUC-
recommended work RVU of 2.00 and are proposing a work RVU of 1.82 based 
on a direct crosswalk to CPT code 50435 (Exchange nephrostomy catheter, 
percutaneous, including diagnostic nephrostogram and/or ureterogram 
when performed, imaging guidance (e.g., ultrasound and/or fluoroscopy) 
and all associated radiological supervision and interpretation). CPT 
code 50435 is a recently reviewed code that also includes radiological 
supervision and interpretation with similar intraservice and total time 
values. In our review of CPT code 36X72, we were concerned about the 
possibility that the recommended work RVU of 2.00 could create a rank 
order anomaly in terms of intensity with the other codes in the family. 
We noted that the recommended intraservice time for CPT code 36X72 as 
compared to CPT code 36568, the most similar code in the family, is 
decreasing from 38 minutes to 22 minutes (42 percent), and the 
recommended total time is decreasing from 71 minutes to 51 minutes (38

[[Page 35752]]

percent); however, the recommended work RVU is only decreasing from 
2.11 to 2.00, which is a reduction of just over 5 percent. We also 
noted that CPT code 36X72 has a lower recommended intraservice time and 
total time as compared to CPT code 36569, yet has a higher recommended 
work RVU. Although we do not imply that the decreases in time as 
reflected in survey values must equate to a one-to-one or linear 
decrease in the valuation of work RVUs, we believe that since the two 
components of work are time and intensity, significant decreases in 
time should be reflected in decreases to work RVUs.
    In the case of CPT code 36X72, we believe that it would be more 
accurate to propose a work RVU of 1.82 based on a crosswalk to CPT code 
50435 to better fit with the recommended work RVUs for CPT codes 36568 
and 36569. The proposed work valuation is also based on the use of 
three additional crosswalk codes: CPT code 32554 (Thoracentesis, needle 
or catheter, aspiration of the pleural space; without imaging 
guidance), CPT code 43198 (Esophagoscopy, flexible, transnasal; with 
biopsy, single or multiple), and CPT code 64644 (Chemodenervation of 
one extremity; 5 or more muscles). All of these codes were recently 
reviewed with similar intensity, intraservice time, and total time 
values, and all three of them also share a work RVU of 1.82.
    For CPT code 36X73 (Insertion of peripherally inserted central 
venous catheter (PICC), without subcutaneous port or pump, including 
all imaging guidance, image documentation, and all associated 
radiological supervision and interpretation required to perform the 
insertion; age 5 years or older), we disagree with the RUC-recommended 
work RVU of 1.90 and are proposing a work RVU of 1.70 based on 
maintaining the current work RVU of CPT code 36569. In our review of 
CPT code 36X73, we were again concerned about the possibility that the 
recommended work RVU of 1.90 could create a rank order anomaly in terms 
of intensity with the other codes in the family. We noted that the 
recommended intraservice time for CPT code 36X73 as compared to CPT 
code 36569, the most similar code in the family, is decreasing from 27 
minutes to 15 minutes (45 percent), and the recommended total time is 
decreasing from 60 minutes to 40 minutes (33 percent); however, the 
RUC-recommended work RVU is exactly the same for these two codes at 
1.90. Although we do not imply that the decreases in time as reflected 
in survey values must equate to a one-to-one or linear decrease in the 
valuation of work RVUs, we believe that since the two components of 
work are time and intensity, significant decreases in time should be 
reflected in decreases to work RVUs.
    In the case of CPT code 36X73, we believe that it would be more 
accurate to propose a work RVU of 1.70 based on maintaining the current 
work RVU of CPT code 36569. These two CPT codes describe the same 
procedure done with (CPT code 36X73) and without (CPT code 35659) 
imaging guidance and radiological supervision and interpretation. 
Because the inclusion of the imaging described by CPT code 36X73 has 
now become the typical case for this service, we believe that it is 
more accurate to maintain the current work RVU of 1.70 as opposed to 
increasing the work RVU to 1.90, especially considering that the new 
surveyed work time for CPT code 36X73 is lower than the current work 
time for CPT code 36569. The proposed work RVU of 1.70 is also based on 
a crosswalk to CPT code 36556 (Insertion of non-tunneled centrally 
inserted central venous catheter; age 5 years or older). This is a 
recently reviewed code with the same 15 minutes of intraservice time 
and the same 40 minutes of total time with a work RVU of 1.75.
    For CPT code 36584, we disagree with the RUC-recommended work RVU 
of 1.47 and are proposing a work RVU of 1.20 based on maintaining the 
current work RVU. We note that the recommended intraservice time for 
CPT code 36584 is decreasing from 15 minutes to 12 minutes (20 percent 
reduction), and the recommended total time is decreasing from 45 
minutes to 34 minutes (25 percent reduction); however, the recommended 
work RVU is increasing from 1.20 to 1.47, an increase of approximately 
23 percent. Although we do not imply that the decreases in time as 
reflected in survey values must equate to a one-to-one or linear 
decrease in the valuation of work RVUs, we believe that since the two 
components of work are time and intensity, significant decreases in 
time should be reflected in decreases to work RVUs. We are especially 
concerned when the recommended work RVU is increasing despite survey 
results indicating that the work time is decreasing due to a 
combination of improving technology and greater efficiencies in 
practice patterns.
    In the case of CPT code 36584, we believe that it would be more 
accurate to propose a work RVU of 1.20 based on maintaining the current 
work RVU for the code. Because the inclusion of the imaging has now 
become the typical case for this service, we believe that it is more 
accurate to maintain the current work RVU of 1.20 as opposed to 
increasing the work RVU to 1.47, especially considering that the new 
surveyed work time for CPT code 36584 is decreasing from the current 
work time. The proposed work RVU of 1.20 is also based on a crosswalk 
to CPT code 40490 (Biopsy of lip), which has the same total time of 34 
minutes and slightly higher intraservice time at a work RVU of 1.22.
    We note that the RUC-recommended work pool is increasing by 
approximately 68 percent for the PICC Line Procedures family as a 
whole, while the RUC-recommended work time pool for the same codes is 
only increasing by about 22 percent. Since time is defined as one of 
the two components of work, we believe that this indicates a 
discrepancy in the recommended work values. We do not believe that the 
recoding of the services in this family has resulted in an increase in 
their intensity, only a change in the way in which they will be 
reported, and therefore, we do not believe that it would serve the 
interests of relativity to propose the RUC-recommended work values for 
all of the codes in this family. We believe that, generally speaking, 
the recoding of a family of services should maintain the same total 
work pool, as the services themselves are not changing, only the coding 
structure under which they are being reported. We also note that, 
through the bundling of some of these frequently reported services, it 
is reasonable to expect that the new coding system will achieve savings 
via elimination of duplicative assumptions of the resources involved in 
furnishing particular servicers. For example, a practitioner would not 
be carrying out the full preservice work three times for CPT codes 
36568, 76937, and 77001, but preservice times were assigned to all of 
the codes under the old coding. We believe the new coding assigns more 
accurate work times and thus reflects efficiencies in resource costs 
that existed but were not reflected in the services as they were 
previously reported.
    For the direct PE inputs, we are proposing to refine the clinical 
labor time for the ``Prepare, set-up and start IV, initial positioning 
and monitoring of patient'' (CA016) activity from 4 minutes to 2 
minutes for CPT codes 36X72 and 36X73. We note that the two reference 
codes for the two new codes, CPT codes 36568 and 36569, currently have 
2 minutes assigned for this activity, and CPT code 36584 also has a 
recommended 2 minutes assigned to this same activity. We do not agree 
that the patient positioning would take twice

[[Page 35753]]

as long for CPT codes 36X72 and 36X73 as compared to the rest of the 
family, and are therefore refining both of them to the same 2 minutes 
of clinical labor time. We are also proposing to refine the equipment 
times in accordance with our standard equipment time formulas.
(16) Biopsy or Excision of Inguinofemoral Node(s) (CPT Code 3853X)
    In September 2017, the CPT Editorial Panel created a new code to 
describe biopsy or excision of inguinofemoral node(s). A parenthetical 
was added to CPT codes 56630 (Vulvectomy, radical, partial) and 56633 
(Vulvectomy, radical, complete) to instruct separate reporting of code 
3853X with radical vulvectomy. This service was previously reported 
with unlisted codes.
    CPT code 3853X (Biopsy or excision of lymph node(s); open, 
inguinofemoral node(s)) is a new CPT code describing a lymph node 
biopsy without complete lymphadenectomy. The RUC recommended a work RVU 
of 6.74 for CPT code 3853X, with 223 minutes of total time and 65 
minutes of intraservice time. We propose the RUC-recommended work RVU 
of 6.74 for CPT code 3853X. However, we are concerned that this CPT 
code is described as having a 10-day global period. The two CPT codes 
that are often reported together with this code, CPT code 56630 
(Vulvectomy, radical, partial) and CPT code 56633 (Vulvectomy, radical, 
complete), are both 90-day global codes. In addition, CPT code 3853X 
has a discharge visit and two follow up visits in the global period. 
This is consistent with the number of postoperative visits typically 
associated with 90-day global codes. Therefore, we propose to assign a 
90-day global indicator for CPT code 3853X rather than the 10-day 
global time period reflected in the RUC recommendation.
    We are not proposing any direct PE refinements for this code 
family.
(17) Radioactive Tracer (CPT Code 38792)
    CPT code 38792 (Injection procedure; radioactive tracer for 
identification of sentinel node) was identified as potentially 
misvalued on a screen of codes with a negative intraservice work per 
unit of time (IWPUT), with 2016 estimated Medicare utilization over 
10,000 for RUC reviewed codes and over 1,000 for Harvard valued and 
CMS/Other source codes. For CY 2019, we are proposing the RUC-
recommended work RVU of 0.65 for CPT code 38792.
    For the direct PE inputs, we are proposing to refine the clinical 
labor time for the ``Prepare room, equipment and supplies'' (CA013) 
activity to 3 minutes and to refine the clinical labor time for the 
``Confirm order, protocol exam'' (CA014) activity to 0 minutes. CPT 
code 38792, as well as its alternate reference code 78300 (Bone and/or 
joint imaging; limited area), both did not previously have clinical 
labor time assigned for the ``Confirm order, protocol exam'' clinical 
labor task, and we do not have any reason to believe that the services 
being furnished by the clinical staff have changed, only the way in 
which this clinical labor time has been presented on the PE worksheets. 
We also note that there is no effect on the total clinical labor direct 
costs in these situations, since the same 3 minutes of clinical labor 
time is still being furnished. We are also proposing to refine the 
equipment times in accordance with our standard equipment time 
formulas.
(18) Percutaneous Change of G-Tube (CPT Code 43760)
    CPT code 43760 (Change of gastrostomy tube, percutaneous, without 
imaging or endoscopic guidance) was identified as potentially misvalued 
on a screen of 0-day global services reported with an E/M visit 50 
percent of the time or more, on the same day of service by the same 
patient and the same practitioner, that have not been reviewed in the 
last 5 years with Medicare utilization greater than 20,000. It was 
surveyed for the April 2017 RUC meeting and recommendations for work 
and direct PE inputs were submitted to CMS. However, the RUC also noted 
that because the data for CPT code 43760 were bimodal, it might be 
appropriate to consider changes in the CPT descriptors to better 
differentiate physician work. In September 2017, the CPT Editorial 
Panel deleted CPT code 43760 and will use two new codes (43X63 and 
43X64) that describe replacement of gastrostomy tube, with and without 
revision of gastrostomy tract, respectively. (See below.) Therefore, we 
are not proposing work or direct PE values for CPT code 43760.
(19) Gastrostomy Tube Replacement (CPT Codes 43X63 and 43X64)
    In September 2017, the CPT Editorial Panel created two new codes 
that describe replacement of gastrostomy tube, with and without 
revision of gastrostomy tract, respectively. These two new codes were 
surveyed for the January 2018 RUC meeting and recommendations for work 
and direct PE inputs were submitted to CMS.
    We are proposing a work RVU of 0.75 for CPT code 43X63 (Replacement 
of gastrostomy tube, percutaneous, includes removal, when performed, 
without imaging or endoscopic guidance; not requiring revision of 
gastrostomy tract.) and a work RVU of 1.41 for CPT code 43X64 
(Replacement of gastrostomy tube, percutaneous, includes removal, when 
performed, without imaging or endoscopic guidance; requiring revision 
of gastrostomy tract.), consistent with the RUC's recommendations for 
these new CPT codes.
    For the direct PE inputs, we are proposing to refine the equipment 
times in accordance with our standard equipment time formulas.
(20) Diagnostic Proctosigmoidoscopy--Rigid (CPT Code 45300)
    CPT code 45300 (Proctosigmoidoscopy, rigid; diagnostic, with or 
without collection of specimen(s) by brushing or washing (separate 
procedure)) was identified as potentially misvalued on a screen of 0-
day global services reported with an E/M visit 50 percent of the time 
or more, on the same day of service by the same patient and the same 
practitioner, that have not been reviewed in the last 5 years with 
Medicare utilization greater than 20,000. For CY 2019, we are proposing 
the RUC-recommended work RVU of 0.80 for CPT code 45300.
    For the direct PE inputs, we are proposing to refine the equipment 
times in accordance with our standard equipment time formulas.
(21) Hemorrhoid Injection (CPT Code 46500)
    CPT code 46500 (Injection of sclerosing solution, hemorrhoids) was 
identified as potentially misvalued on a screen of codes with a 
negative intraservice work per unit of time (IWPUT), with 2016 
estimated Medicare utilization over 10,000 for RUC reviewed codes and 
over 1,000 for Harvard valued and CMS/Other source codes.
    For CPT code 46500, we disagree with the RUC-recommended work RVU 
of 2.00 and we are proposing a work RVU of 1.74 based on a direct 
crosswalk to CPT code 68811 (Probing of nasolacrimal duct, with or 
without irrigation; requiring general anesthesia). This is another 
recently-reviewed 10-day global code with the same 10 minutes of 
intraservice time and slightly higher total time. When CPT code 46500 
was previously reviewed as described in the CY 2016 PFS final rule with 
comment period (80 FR 70963), we finalized a proposal to reduce the 
work RVU from 1.69 to 1.42, which reduced the work RVU by the same 
ratio as the

[[Page 35754]]

reduction in the total work time. In light of the additional evidence 
provided by this new survey, we agree that the work RVU should be 
increased from the current value of 1.42. However, we believe that our 
proposed work RVU of 1.74 based on a crosswalk to CPT code 68811 is 
more accurate than the RUC-recommended work RVU of 2.00.
    In the most recent survey of CPT code 46500, the intraservice work 
time remained unchanged at 10 minutes while the total time increased by 
only 2 minutes, increasing from 59 minutes to 61 minutes (3 percent). 
However, the RUC-recommended work RVU is increasing from 1.42 to 2.00, 
an increase of 41 percent, and also an increase of 19 percent over the 
historic value of 1.69 for CPT code 46500. Although we do not imply 
that the increase in time as reflected in survey values must equate to 
a one-to-one or linear increase in the valuation of work RVUs, we 
believe that since the two components of work are time and intensity, 
minimal increases in surveyed work time typically should not be 
reflected in disproportionately large increases to work RVUs. In the 
case of CPT code 46500, we believe that our crosswalk to CPT code 68811 
at a work RVU of 1.74 more accurately maintains relativity with other 
10-day global codes on the PFS. We also note that the 3 percent 
increase in surveyed work time for CPT code 46500 matches a 3 percent 
increase in the historic work RVU of the code, from 1.69 to 1.74. 
Therefore, we are proposing a work RVU of 1.74 for CPT code 46500 based 
on the aforementioned crosswalk.
    For the direct PE inputs, we are proposing to remove 10 minutes of 
clinical labor time for the ``Assist physician or other qualified 
healthcare professional--directly related to physician work time 
(100%)'' (CA018) activity. This clinical labor time is listed twice in 
the recommendations along with a statement that although the clinical 
labor has not changed from prior reviews, time for both clinical staff 
members was inadvertently not included in the previous spreadsheets. We 
appreciate this notification in the recommendations, and therefore, we 
are asking for more information about why the clinical labor associated 
with this additional staff member was left out for previous reviews. We 
are particularly interested in knowing what activities the additional 
staff member would be undertaking during the procedure. We are 
proposing to remove the clinical labor associated with this additional 
clinical staff member pending the receipt of additional information. We 
are also proposing to remove 1 impervious staff gown (SB027), 1 
surgical mask with face shield (SB034), and 1 pair of shoe covers 
(SB039) pending more information about the additional clinical staff 
member.
    We are proposing to remove the clinical labor time for the ``Review 
home care instructions, coordinate visits/prescriptions'' (CA035) 
activity. CPT code 46500 is typically billed with a same day E/M 
service, and we believe that it would be duplicative to assign clinical 
labor time for reviewing home care instructions given that this task 
would typically be done during the same day E/M service. We are also 
proposing to refine the equipment times in accordance with our standard 
equipment time formulas.
(22) Removal of Intraperitoneal Catheter (CPT Code 49422)
    In October 2016, CPT code 49422 (Removal of tunneled 
intraperitoneal catheter) was identified as a site of service anomaly 
because Medicare data from 2012-2014 indicated that it was performed 
less than 50 percent of the time in the inpatient setting, yet included 
inpatient hospital E/M services within the 10-day global period. The 
code was resurveyed using a 0-day global period for the April 2017 RUC 
meeting. For CY 2019, we are proposing the RUC-recommended work RVU of 
4.00 for CPT code 49422.
    We are not proposing any direct PE refinements for this code 
family.
(23) Dilation of Urinary Tract (CPT Codes 50X39, 50X40, 52334, and 
74485)
    In October 2014, the CPT Editorial Panel deleted six codes and 
created twelve new codes to describe genitourinary catheter procedures 
and bundle inherent imaging services. In January 2015, the specialty 
societies indicated that CPT code 50395 (Introduction of guide into 
renal pelvis and/or ureter with dilation to establish nephrostomy 
tract, percutaneous), which was identified as part of the family, would 
be referred to the CPT Editorial Panel to clear up any confusion with 
overlap in physician work with CPT code 50432 (Placement of nephrostomy 
catheter, percutaneous, including diagnostic nephrostogram and/or 
ureterogram when performed, imaging guidance (e.g., ultrasound and/or 
fluoroscopy) and all associated radiological supervision and 
interpretation). In September 2017, the CPT Editorial Panel deleted CPT 
code 50395 and created two new codes to report dilation of existing 
tract, and establishment of new access to the collecting system, 
including percutaneous, for an endourologic procedure including imaging 
guidance (e.g., ultrasound and/or fluoroscopy), all associated 
radiological supervision and interpretation, as well as post procedure 
tube placement when performed.
    The specialty society surveyed the new CPT code 50X39 (Dilation of 
existing tract, percutaneous, for an endourologic procedure including 
imaging guidance (e.g., ultrasound and/or fluoroscopy) and all 
associated radiological supervision and interpretation, as well as post 
procedure tube placement, when performed), and the RUC recommended a 
total time of 70 minutes, intraservice time of 30 minutes, and a work 
RVU of 3.37. The RUC indicated that its recommended work RVU for this 
CPT code is identical to the work RVU of the CPT code being deleted, 
even though imaging guidance CPT code 74485 has now been bundled into 
the valuation of the CPT code. The RUC provided two key reference CPT 
codes to support its recommendation: CPT code 50694 (Placement of 
ureteral stent, percutaneous, including diagnostic nephrostogram and/or 
ureterogram when performed, imaging guidance (e.g., ultrasound and/or 
fluoroscopy), and all associated radiological supervision and 
interpretation; new access, without separate nephrostomy catheter) with 
total time of 111 minutes, intraservice time of 62 minutes, and a work 
RVU of 5.25; and CPT code 50695 (Placement of ureteral stent, 
percutaneous, including diagnostic nephrostogram and/or ureterogram 
when performed, imaging guidance (e.g., ultrasound and/or fluoroscopy), 
and all associated radiological supervision and interpretation; new 
access, with separate nephrostomy catheter), with total time of 124 
minutes and intraservice time of 75 minutes, and a work RVU of 6.80. To 
further support its recommendation, the RUC also referenced CPT code 
52287 (Cystourethroscopy, with injection(s) for chemodenervation of the 
bladder) with total time of 58 minutes, intraservice time of 21 
minutes, and a work RVU of 3.37. We disagree with the RUC that the work 
RVU for this CPT code should be the same as the CPT code being deleted. 
Survey respondents indicated that the total time for completing the 
service described by the new CPT code is nearly 30 minutes less than 
the existing CPT code, even though imaging guidance was described as 
part of the procedure. We also note that the reference CPT codes both 
have substantially higher total and intraservice times than CPT code 
50X39. We considered a number of parameters to arrive at our proposed 
work RVU of 2.78, supported by a

[[Page 35755]]

crosswalk to CPT code 31646 (Bronchoscopy, rigid or flexible, including 
fluoroscopic guidance, when performed; with therapeutic aspiration of 
tracheobronchial tree, subsequent, same hospital stay). We examined the 
intraservice time ratio for the new CPT code in relation to the 
combination of CPT codes that the service represents and found that 
this would support a work RVU of 2.55. We also calculated the 
intraservice time ratio for the new CPT code in relation to each of the 
two reference CPT codes. For the comparison with CPT code 50694, the 
intraservice time ratio is 2.54, while the comparison with the second 
reference CPT code 50695 yields an intraservice time ratio of 2.72. We 
took the highest of these three values, 2.72, and found a corresponding 
crosswalk that we believe appropriately values the service described by 
the new CPT code. Therefore, we are proposing a work RVU of 2.78 for 
CPT code 50X39.
    The specialty society also surveyed the new CPT code 50X40 
(Dilation of existing tract, percutaneous, for an endourologic 
procedure including imaging guidance (e.g., ultrasound and/or 
fluoroscopy) and all associated radiological supervision and 
interpretation, as well as post procedure tube placement, when 
performed; including new access into the renal collecting system) and 
the RUC recommended a total time of 100 minutes, an intraservice time 
of 60 minutes, and a work RVU of 5.44. The recommended intraservice 
time of 60 minutes reflects the 75th percentile of survey results, 
rather than the median survey time, which is typically used for 
determining the intraservice time for new CPT codes. The RUC justified 
the use of the higher intraservice time because they believe the time 
better represents the additional time needed to introduce the guidewire 
into the renal pelvis and/or ureter, above and beyond the work involved 
in performing CPT code 50X39. The RUC compared this CPT code to CPT 
code 52235 (Cystourethroscopy, with fulguration (including cryosurgery 
or laser surgery) and/or resection of; MEDIUM bladder tumor(s) (2.0 to 
5.0 cm)), with total time of 94 minutes, intraservice time of 45 
minutes, and a work RVU of 5.44. The RUC also cited, as support, the 
second key reference CPT code 50694 (Placement of ureteral stent, 
percutaneous, including diagnostic nephrostogram and/or ureterogram 
when performed, imaging guidance (e.g., ultrasound and/or fluoroscopy), 
and all associated radiological supervision and interpretation; new 
access, without separate nephrostomy catheter) with total time 111 
minutes, intraservice time 62 minutes, and a work RVU of 5.25. We do 
not agree with the RUC's recommended work RVU because we believe that 
the intraservice time for this CPT code should reflect the survey 
median rather than the 75th percentile. There is no indication that the 
additional work of imaging guidance was systematically excluded by 
survey respondents when estimating the time needed to furnish the 
service. Therefore, we are proposing to reduce the intraservice time 
for CPT code 50X40 from the RUC-recommended 60 minutes to the survey 
median time of 45 minutes. We note that this is still 15 minutes more 
than the intraservice time for CPT code 50X39, primarily for the 
provider to introduce the guidewire into the renal pelvis and/or 
ureter. We welcome comments about the amount of time needed to furnish 
this procedure. With the revised intraservice time of 45 minutes and a 
total time of 85 minutes, we believe that the RUC-recommended work RVU 
for this CPT code is overstated. When we apply the increment between 
the RUC-recommended values for between CPT codes 50X39 and 50X40 (2.07 
work RVUs) in addition to our proposed work RVU for CPT code 50X39, we 
estimate that this CPT code is more accurately represented by a work 
RVU of 4.83. This value is supported by a crosswalk to CPT code 36902 
(Introduction of needle(s) and/or catheter(s), dialysis circuit, with 
diagnostic angiography of the dialysis circuit, including all direct 
puncture(s) and catheter placement(s), injection(s) of contrast, all 
necessary imaging from the arterial anastomosis and adjacent artery 
through entire venous outflow including the inferior or superior vena 
cava, fluoroscopic guidance, radiological supervision and 
interpretation and image documentation and report; with transluminal 
balloon angioplasty, peripheral dialysis segment, including all imaging 
and radiological supervision and interpretation necessary to perform 
the angioplasty), which has intraservice time of 40 minutes and total 
time of 86 minutes. We believe that CPT code 36902 describes a service 
that is similar to the new CPT code 50X40) and therefore provides a 
reasonable crosswalk. We are proposing a work RVU of 4.83 for CPT code 
50X40.
    We are proposing the RUC-recommended work RVU of 3.37 for CPT code 
52334 (Cystourethroscopy with insertion of ureteral guide wire through 
kidney to establish a percutaneous nephrostomy, retrograde) and the 
RUC-recommended work RVU of 0.83 for CPT code 74485 (Dilation of 
ureter(s) or urethra, radiological supervision and interpretation).
    For the direct PE inputs, we are proposing to remove the clinical 
labor time for the ``Confirm availability of prior images/studies'' 
(CA006) activity for CPT code 52334. This code does not currently 
include this clinical labor time, and unlike the two new codes in the 
family (CPT codes 50X39 and 50X40), CPT code 52234 does not include 
imaging guidance in its code descriptor. When CPT code 52234 is 
performed with imaging guidance, it would be billed together with a 
separate imaging code that already includes clinical labor time for 
confirming the availability of prior images. As a result, we believe 
that it would be duplicative to include this clinical labor time in CPT 
code 52234.
(24) Transurethral Destruction of Prostate Tissue (CPT Codes 53850, 
53852, and 538X3)
    In September 2017, the CPT Editorial Panel created a new code (CPT 
code 538X3) to report transurethral destruction of prostate tissue by 
radiofrequency-generated water vapor thermotherapy. CPT codes 53850 
(Transurethral destruction of prostate tissue; by microwave 
thermotherapy) and 53852 (Transurethral destruction of prostate tissue; 
by radiofrequency thermotherapy) were also included for review as part 
of the same family of codes.
    For CPT code 53850 (Transurethral destruction of prostate tissue; 
by microwave thermotherapy), the RUC- recommended a work RVU of 5.42, 
supported by a direct crosswalk to CPT code 33272 (Removal of 
subcutaneous implantable defibrillator electrode) with a total time of 
151 minutes, intraservice time of 45 minutes, and a work RVU of 5.42. 
The RUC indicated that a work RVU of 5.42 accurately reflects the 
lowest value of the three CPT codes in this family. We are proposing 
the work RVU of 5.42 for CPT code 53850, as recommended by the RUC.
    The RUC recommended a work RVU of 5.93 for CPT code 53852 
(Transurethral destruction of prostate tissue; by radiofrequency 
thermotherapy) and for CPT code 538X3 (Transurethral destruction of 
prostate tissue; by radiofrequency generated water vapor 
thermotherapy). We are proposing the RUC-recommended value of 5.93 for 
CPT code 53852.
    CPT code 538X3 (Transurethral destruction of prostate tissue; by 
radiofrequency generated water vapor thermotherapy) is a service 
reflecting

[[Page 35756]]

the use of a new technology, ``radiofrequency generated water vapor 
thermotherapy,'' as distinct from CPT code 53852, which describes 
destruction of tissue by ``radiofrequency thermotherapy.'' The RUC 
indicated that this CPT code is the most intense of the three CPT codes 
in this family, thereby justifying a work RVU identical to that of CPT 
code 53852 despite lower intraservice and total times. The RUC stated 
that 15 minutes of post service time is appropriate due to greater 
occurrence of post-procedure hematuria necessitating a longer 
monitoring time. However, the post-service monitoring time for this CPT 
code, 15 minutes, is identical to that for CPT code 53852. We do not 
agree with the explanation provided by the RUC for recommending a work 
RVU identical to that of CPT code 53852, given that the total time is 5 
minutes lower, and the post service times are identical. Both the 
intraservice time ratio between this new CPT code and CPT code 53852 
(4.94) and the total time ratio between the two CPT codes (5.72) 
suggest that the RUC-recommended work RVU of 5.93 overestimates the 
work involved in furnishing this service. We reviewed other 90-day 
global CPT codes with similar times and identified CPT code 24071 
(Excision, tumor, soft tissue of upper arm or elbow area, subcutaneous; 
3 cm or greater) with a total time of 183 minutes, intraservice time of 
45 minutes, and a work RVU of 5.70 as an appropriate crosswalk. We 
believe that this is a better reflection of the work involved in 
furnishing CPT code 538X3, and therefore, we are proposing a work RVU 
of 5.70 for this CPT code. We welcome comments about the time and 
intensity required to furnish this new service. Since this CPT code 
reflects the use of a new technology, it will be reviewed again in 3 
years.
    For the direct PE inputs, we are proposing to add a new supply 
(SA128: ``kit, Rezum delivery device''), a new equipment item (EQ389: 
``generator, water thermotherapy procedure''), and updating the price 
of two supplies (SA036: ``kit, transurethral microwave thermotherapy'' 
and SA037: ``kit, transurethral needle ablation (TUNA)'') in response 
to the submission of invoices. We note that these invoices were 
submitted along with additional information listing the vendor discount 
for these supplies and equipment. We appreciate the inclusion of the 
discounted prices on these invoices, and we encourage other invoice 
submissions to provide the discounted price as well where available. 
Based on the market research on supply and equipment pricing carried 
out by our contractors, we have reason to believe that a vendor 
discount of 10-15 percent is common on many supplies and equipment. 
Since we are obligated by statute to establish RVUs for each service as 
required based on the resource inputs required to furnish the typical 
case of a service, we have concerns that relying on invoices for supply 
and equipment pricing absent these vendor discounts may overestimate 
the resource cost of some services. We encourage the submission of 
additional invoices that include the discounted price of supplies and 
equipment to more accurately assess the market cost of these resources. 
Furthermore, we refer readers to our discussion of the market-based 
supply and equipment pricing update detailed in section II.B. of this 
proposed rule.
(25) Vaginal Treatments (CPT Codes 57150 and 57160)
    CPT codes 57150 (Irrigation of vagina and/or application of 
medicament for treatment of bacterial, parasitic, or fungoid disease) 
and 57160 (Fitting and insertion of pessary or other intravaginal 
support device) were identified as potentially misvalued on a screen of 
0-day global services reported with an E/M visit 50 percent of the time 
or more, on the same day of service by the same patient and the same 
practitioner, that have not been reviewed in the last 5 years with 
Medicare utilization greater than 20,000. For CY 2019, we are proposing 
the RUC-recommended work RVU of 0.50 for CPT code 57150 and the RUC-
recommended work RVU of 0.89 for CPT code 57160.
    We are not proposing any direct PE refinements for this code 
family.
(26) Biopsy of Uterus Lining (CPT Codes 58100 and 58110)
    CPT code 58100 (Endometrial sampling (biopsy) with or without 
endocervical sampling (biopsy), without cervical dilation, any method) 
was identified as potentially misvalued on a screen of 0-day global 
services reported with an E/M visit 50 percent of the time or more, on 
the same day of service by the same patient and the same practitioner, 
that have not been reviewed in the last 5 years with Medicare 
utilization greater than 20,000. CPT code 58110 (Endometrial sampling 
(biopsy) performed in conjunction with colposcopy) was also included 
for review as part of the same family of codes. For CY 2019, we are 
proposing the RUC-recommended work RVU of 1.21 for CPT code 58100 and 
the RUC-recommended work RVU of 0.77 for CPT code 58110.
    For the direct PE inputs, we are proposing to remove the clinical 
labor time for the ``Review/read post-procedure x-ray, lab and 
pathology reports'' (CA028) activity for CPT code 58100. This code is 
typically billed with a same day E/M service, and we believe that it 
would be duplicative to assign clinical labor time for reviewing 
reports given that this task would typically be done during the same 
day E/M service. We are also proposing to refine the equipment times in 
accordance with our standard equipment time formulas.
(27) Injection Greater Occipital Nerve (CPT Code 64405)
    CPT code 64405 (Injection, anesthetic agent; greater occipital 
nerve) was identified as potentially misvalued on a screen of 0-day 
global services reported with an E/M visit 50 percent of the time or 
more, on the same day of service by the same patient and the same 
practitioner, that have not been reviewed in the last 5 years with 
Medicare utilization greater than 20,000. For CY 2019, we are proposing 
the RUC-recommended work RVU of 0.94 for CPT code 64405.
    For the direct PE inputs, we are proposing to refine the equipment 
time for the exam table (EF023) in accordance with our standard 
equipment time formulas.
(28) Injection Digital Nerves (CPT Code 64455)
    CPT code 64455 (Injection(s), anesthetic agent and/or steroid, 
plantar common digital nerve(s) (e.g., Morton's neuroma)) was 
identified as potentially misvalued on a screen of 0-day global 
services reported with an E/M visit 50 percent of the time or more, on 
the same day of service by the same patient and the same practitioner, 
that have not been reviewed in the last 5 years with Medicare 
utilization greater than 20,000. For CY 2019, we are proposing the RUC-
recommended work RVU of 0.75 for CPT code 64455.
    For the direct PE inputs, we are proposing to refine the equipment 
time for the exam table (EF023) in accordance with our standard 
equipment time formulas.
(29) Removal of Foreign Body--Eye (CPT Codes 65205 and 65210)
    CPT codes 65205 (Removal of foreign body, external eye; 
conjunctival superficial) and 65210 (Removal of foreign body, external 
eye; conjunctival embedded (includes concretions), subconjunctival, or 
scleral nonperforating) were identified as potentially misvalued on a 
screen of 0-day global services reported with an

[[Page 35757]]

E/M visit 50 percent of the time or more, on the same day of service by 
the same patient and the same practitioner, that have not been reviewed 
in the last 5 years with Medicare utilization greater than 20,000.
    For CY 2019, we are proposing the RUC-recommended work RVU of 0.49 
for CPT code 65205. We note that the recommendations for this code 
included a statement that the work required to perform CPT code 65205 
and the procedure itself had not fundamentally changed since the time 
of the last review. However, due to the fact that the surveyed 
intraservice time had decreased from 5 minutes to 3 minutes, the work 
RVU was lowered from the current value of 0.71 to the recommended work 
RVU of 0.49, based on a direct crosswalk to CPT code 68200 
(Subconjunctival injection). We note that this recommendation appears 
to have been developed under a methodology similar to our ongoing use 
of time ratios as one of several methods used to evaluate work. We used 
time ratios to identify potential work RVUs and considered these work 
RVUs as potential options relative to the values developed through 
other options. As we have stated in past rulemaking (such as 82 FR 
53032-53033), we do not imply that the decrease in time as reflected in 
survey values must equate to a one-to-one or linear decrease in newly 
valued work RVUs, as indeed it does not in the case of CPT code 65205 
here. Instead, we believed that, since the two components of work are 
time and intensity, significant decreases in time should be reflected 
in decreases to work RVUs. We appreciate that the RUC-recommended work 
RVU for CPT code 65205 has taken these changes in work time into 
account, and we support the use of similar methodologies, where 
appropriate, in future work valuations.
    For CPT code 65210, we disagree with the RUC-recommended work RVU 
of 0.75 and we are proposing a work RVU of 0.61 based on a direct 
crosswalk to CPT code 92511 (Nasopharyngoscopy with endoscope). This 
crosswalk code has the same intraservice time of 5 minutes and 4 
additional minutes of total time as compared to CPT code 65210. We note 
that the recommended intraservice time for CPT code 65210 is decreasing 
from 13 minutes to 5 minutes (62 percent reduction), and the 
recommended total time for CPT code 65210 is decreasing from 25 minutes 
to 13 minutes (48 percent reduction); however, the RUC-recommended work 
RVU is only decreasing from 0.84 to 0.75, which is a reduction of about 
11 percent. As we noted earlier, we do not believe that the decrease in 
time as reflected in survey values must equate to a one-to-one or 
linear decrease in the valuation of work RVUs, and we are not proposing 
a linear decrease in the work valuation based on these time ratios. 
However, we believe that since the two components of work are time and 
intensity, significant decreases in time should be reflected in 
decreases to work RVUs, and we do not believe that the recommended work 
RVU of 0.75 appropriately reflects these decreases in surveyed work 
time.
    Our proposed work RVU of 0.61 is also based on a crosswalk to CPT 
code 51700 (Bladder irrigation, simple, lavage and/or instillation), 
another recently reviewed code with higher time values and a work RVU 
of 0.60. We also note that two injection codes (CPT codes 20551 and 
64455) were reviewed at the same RUC meeting as CPT code 65210, each of 
which shared the same intraservice time of 5 minutes and had a higher 
total time of 21 minutes. Both of these codes had a RUC-recommended 
work RVU of 0.75, which we are proposing without refinement for CY 
2019. Due to the fact that CPT code 65210 has a lower total time and a 
lower intensity than both of these injection procedures, we did not 
agree that CPT code 65210 should be valued at the same work RVU of 
0.75. We believe that our proposed work RVU of 0.61 based on a 
crosswalk to CPT code 92511 is a more accurate value for this code.
    For the direct PE inputs, we noted that the RUC-recommended 
equipment time for the screening lane (EL006) equipment in CPT codes 
65205 and 65210 was equal to the total work time in addition to the 
clinical labor time needed to set up and clean the equipment. We 
disagree that the screening lane would typically be in use for the 
total work time, given that this includes the preservice evaluation 
time and the immediate postservice time. Although we are not currently 
proposing to refine the equipment time for the screening lane in these 
two codes, we are soliciting comments on whether the use of the 
intraservice work time would be more typical than the total work time 
for CPT codes 65205 and 65210.
(30) Injection--Eye (CPT Codes 67500, 67505, and 67515)
    CPT code 67515 (Injection of medication or other substance into 
Tenon's capsule) was identified as potentially misvalued on a screen of 
0-day global services reported with an E/M visit 50 percent of the time 
or more, on the same day of service by the same patient and the same 
practitioner, that have not been reviewed in the last 5 years with 
Medicare utilization greater than 20,000. CPT codes 67500 (Retrobulbar 
injection; medication (separate procedure, does not include supply of 
medication)) and 67505 (Retrobulbar injection; alcohol) were also 
included for review as part of the same family of codes. For CY 2019, 
we are proposing the RUC-recommended work RVU of 1.18 for CPT code 
67500.
    For CPT code 67505, we disagree with the RUC-recommended work RVU 
of 1.18 and we are proposing a work RVU of 0.94 based on a direct 
crosswalk to CPT code 31575 (Laryngoscopy, flexible; diagnostic). This 
is a recently reviewed code with the same intraservice time of 5 
minutes and 2 fewer minutes of total time as compared to CPT code 
67505. We disagreed with the recommendation to propose the same work 
RVU of 1.18 for both CPT code 67500 and 67505 for several reasons. We 
noted that the current work RVU of 1.44 for CPT code 67500 is higher 
than the current work RVU of 1.27 for CPT code 67505, while the current 
work time of CPT code 67500 is less than the current work time for CPT 
code 67505. This supported the view that CPT code 67500 should be 
valued higher than CPT code 67505 due to its greater intensity, which 
we also found to be supportable on clinical grounds. The typical 
patient for CPT code 67505 has already lost their sight, and there is 
less of a concern about accidental blindness as compared to CPT code 
67500. At the recommended identical work RVUs, CPT code 67500 has 
almost triple the intensity of CPT code 67505. Similarly, the intensity 
does not match our clinical understanding of the complexity and 
difficulty of the two procedures.
    We also noted that the surveyed total time for CPT code 67505 was 7 
minutes less than the surveyed time for CPT code 67500, approximately 
21 percent lower. If we were to take the total time ratio between the 
two codes, it would produce a suggested work RVU of 0.93 (26 minutes 
divided by 33 minutes times a work RVU of 1.18). This time ratio 
suggested a work RVU almost identical to the 0.94 value that we 
determined via a crosswalk to CPT code 31575. Based on the preceding 
rationale, we are proposing a work RVU of 0.94 for CPT code 67505.
    For CPT code 67515, we disagree with the RUC-recommended work RVU 
of 0.84 and we are proposing a work RVU of 0.75 based on a crosswalk to 
CPT code 64450 (Injection, anesthetic agent; other peripheral nerve or 
branch). The recommended work RVU is based on a direct crosswalk to CPT 
code 65222 (Removal of foreign body, external eye;

[[Page 35758]]

corneal, with slit lamp) at a work RVU of 0.84. However, the 
recommended crosswalk code has more than double the intraservice time 
of CPT code 67515 at 7 minutes, and we believe that it would be more 
accurate to use a crosswalk to a code with a more similar intraservice 
time such as CPT code 64450, which is another type of injection 
procedure. The proposed work RVU of 0.75 is also based on the use of 
the intraservice time ratio with the first code in the family, CPT code 
67500. The intraservice time ratio between these codes is 0.60 (3 
minutes divided by 5 minutes), which yields a suggested work RVU of 
0.71 when multiplied by the recommended work RVU of 1.18 for CPT code 
67500. We believe that this provides further rationale for our proposed 
work RVU of 0.75 for CPT code 67515.
    We are not proposing any direct PE refinements for this code 
family.
(31) X-Ray Spine (CPT Codes 72020, 72040, 72050, 72052, 72070, 72072, 
72074, 72080, 72100, 72110, 72114, and 72120)
    CPT codes 72020 (Radiologic examination, spine, single view, 
specify level) and 72072 (Radiologic examination, spine; thoracic, 3 
views) were identified on a screen of CMS or Other source codes with 
Medicare utilization greater than 100,000 services annually. The code 
family was expanded to include ten additional CPT codes to be reviewed 
together as a group: CPT codes 72040 (Radiologic examination, spine, 
cervical; 2 or 3 views), 72050 (Radiologic examination, spine, 
cervical; 4 or 5 views), 72052 (Radiologic examination, spine, 
cervical; 6 or more views), 72070 (Radiologic examination, spine; 
thoracic, 2 views), 72074 (Radiologic examination, spine; thoracic, 
minimum of 4 views), 72080 (Radiologic examination, spine; 
thoracolumbar junction, minimum of 2 views), 72100 (Radiologic 
examination, spine, lumbosacral; 2 or 3 views), 72110 (Radiologic 
examination, spine, lumbosacral; minimum of 4 views), 72114 (Radiologic 
examination, spine, lumbosacral; complete, including bending views, 
minimum of 6 views), and 72120 (Radiologic examination, spine, 
lumbosacral; bending views only, 2 or 3 views).
    The radiologic examination procedures described by CPT codes 72020 
(Radiologic examination, spine, single view, specify level), 72040 
(Radiologic examination, spine, cervical; 2 or 3 views), 72050 
(Radiologic examination, spine, cervical; 4 or 5 views), 72052 
(Radiologic examination, spine, cervical; 6 or more views), 72070 
(Radiologic examination, spine; thoracic, 2 views), 72072 (Radiologic 
examination, spine; thoracic, 3 views), 72074 (Radiologic examination, 
spine; thoracic, minimum of 4 views), 72080 (Radiologic examination, 
spine; thoracolumbar junction, minimum of 2 views), 72100 (Radiologic 
examination, spine, lumbosacral; 2 or 3 views), 72110 (Radiologic 
examination, spine, lumbosacral; minimum of 4 views), 72114 (Radiologic 
examination, spine, lumbosacral; complete, including bending views, 
minimum of 6 views), 72120 (Radiologic examination, spine, lumbosacral; 
bending views only, 2 or 3 views), 72200 (Radiologic examination, 
sacroiliac joints; less than 3 views), 72202 (Radiologic examination, 
sacroiliac joints; 3 or more views), 72220 (Radiologic examination, 
sacrum and coccyx, minimum of 2 views), 73070 (Radiologic examination, 
elbow; 2 views), 73080 (Radiologic examination, elbow; complete, 
minimum of 3 views), 73090 (Radiologic examination; forearm, 2 views), 
73650 (Radiologic examination; calcaneus, minimum of 2 views), and 
73660 (Radiologic examination; toe(s), minimum of 2 views) were all 
identified as potentially misvalued through a screen for CPT codes with 
high utilization. With approval from the RUC Research Subcommittee, the 
specialty societies responsible for reviewing these CPT codes did not 
conduct surveys, but instead employed a ``crosswalk methodology,'' in 
which they derived physician work and time components for CPT codes by 
comparing them to similar CPT codes. We recognize that a substantial 
amount of time and effort is involved in conducting surveys of 
potentially misvalued CPT codes; however, we have concerns about the 
quality of the underlying data used to value these CPT codes. The 
descriptors and other information on which the recommendations are 
based have themselves not been surveyed, in several instances, since 
1995. There is no new information about any of these CPT codes that 
would allow us to detect any potential improvements in efficiency of 
furnishing the service or evaluate whether changes in practice patterns 
have affected time and intensity. We are not categorically opposed to 
changes in process or methodology that might reduce the burden of 
conducting surveys, but without the benefit of any additional data, 
through surveys or otherwise, we are not convinced that there is a 
basis for evaluating the RUC's recommendations for work RVUs for each 
of these CPT codes.
    Since all 20 of the CPT codes in this group have very similar 
intraservice (from 3-5 minutes) and total (ranging from 5-8 minutes) 
times, we are proposing to use an alternative approach to the valuation 
of work RVUs for these CPT codes. We calculated the utilization-
weighted average RUC-recommended work RVU for the 20 CPT codes. The 
result of this calculation is a work RVU of 0.23, which we propose to 
apply uniformly to each CPT code: 72020, 72040, 72050, 72052, 72070, 
72072, 72074, 72080, 72100, 72110, 72114, 72120, 72200, 72202, 72220, 
73070, 73080, 73090, 73650, and 73660. We recognize that the proposed 
work RVU for some of these CPT codes may be somewhat lower at the code 
level than the RUC's recommendation, while the proposed work RVU for 
other CPT codes may be slightly higher than the RUC's recommended 
value. We nevertheless believe that the alternative, accepting the 
RUC's recommendation for each separate CPT code implies a level of 
precision about the time and intensity of the CPT codes that we have no 
way to validate.
    For the direct PE inputs, we are proposing to add a patient gown 
(SB026) supply to CPT code 72120. We noted that all of the other codes 
in the family that included clinical labor time for the ``Greet 
patient, provide gowning, ensure appropriate medical records are 
available'' (CA009) task included a patient gown, and we are proposing 
to add the patient gown to match the other codes in the family. We 
believe that the exclusion of the patient gown for CPT code 72120 was 
most likely due to a clerical error in the recommendations. We are also 
proposing to refine the equipment time for the basic radiology room 
(EL012) in accordance with our standard equipment time formulas.
    In our review of the clinical labor time recommended for the 
``Perform procedure/service--NOT directly related to physician work 
time'' (CA021) task, we noted that the standard convention for this 
family of codes seemed to be 3 minutes of clinical labor time per view 
being conducted. For example, CPT code 72020 with a single view had 3 
minutes of recommended clinical labor time for this activity, while CPT 
code 72070 with two views had 6 minutes. However, we also noted that 
for the codes with 2-3 views such as CPT codes 72040 and 72100, the 
recommended clinical labor time of 9 minutes appears to assume that 3 
views would always be typical for the procedure. The same pattern 
occurred for codes with 4-5 views, which have a

[[Page 35759]]

recommended clinical labor time of 15 minutes (assuming 5 views is 
typical), and for codes with 6 or more views, which have a recommended 
clinical labor time of 21 minutes (assuming 7 views is typical).
    We are not proposing to refine the clinical labor times for this 
task as we do not have data available to know how many views would be 
typical for these CPT codes. However, we note that the intraservice 
clinical labor time has not changed in roughly 2 decades for these X-
ray services, including during this most recent review, and we believe 
that improving technology during this span of time may have resulted in 
greater efficiencies in the procedures. We continue to be interested in 
data sources regarding the intraservice clinical labor times for 
services such as these that do not match the physician intraservice 
time, and we welcome any comments that may be able to provide 
additional details for the twelve codes under review in this family.
(32) X-Ray Sacrum (CPT Codes 72200, 72202, and 72220)
    CPT code 72220 (Radiologic examination, sacrum and coccyx, minimum 
of 2 views) was identified on a screen of CMS or Other source codes 
with Medicare utilization greater than 100,000 services annually. CPT 
codes 72200 (Radiologic examination, sacroiliac joints; less than 3 
views) and 72202 (Radiologic examination, sacroiliac joints; 3 or more 
views) were also included for review as part of the same family of 
codes. See (31) X-Ray Spine (CPT codes 72020, 72040, 72050, 72052, 
72070, 72072, 72074, 72080, 72100, 72110, 72114, and 72120) for a 
discussion of proposed work RVUs for these codes.
    For the direct PE inputs, we are proposing to refine the equipment 
time for the basic radiology room (EL012) in accordance with our 
standard equipment time formulas.
(33) X-Ray Elbow-Forearm (CPT Codes 73070, 73080, and 73090)
    CPT codes 73070 (Radiologic examination, elbow; 2 views) and 73090 
(Radiologic examination; forearm, 2 views) were identified on a screen 
of CMS or Other source codes with Medicare utilization greater than 
100,000 services annually. CPT code 73080 (Radiologic examination, 
elbow; complete, minimum of 3 views) was also included for review as 
part of the same family of codes. See (31) X-Ray Spine (CPT codes 
72020, 72040, 72050, 72052, 72070, 72072, 72074, 72080, 72100, 72110, 
72114, and 72120) above for a discussion of proposed work RVUs for 
these codes.
    For the direct PE inputs, we are proposing to refine the equipment 
time for the basic radiology room (EL012) in accordance with our 
standard equipment time formulas.
(34) X-Ray Heel (CPT Code 73650)
    CPT code 73650 (Radiologic examination; calcaneus, minimum of 2 
views) was identified on a screen of CMS or Other source codes with 
Medicare utilization greater than 100,000 services annually. See (31) 
X-Ray Spine above for a discussion of proposed work RVUs for these 
codes.
    For the direct PE inputs, we are proposing to refine the equipment 
time for the basic radiology room (EL012) in accordance with our 
standard equipment time formulas.
(35) X-Ray Toe (CPT Code 73660)
    CPT code 73660 (Radiologic examination; toe(s), minimum of 2 views) 
was identified on a screen of CMS or Other source codes with Medicare 
utilization greater than 100,000 services annually. See (31) X-Ray 
Spine above for a discussion of proposed work RVUs for these codes.
    For the direct PE inputs, we are proposing to add a patient gown 
(SB026) supply to CPT code 73660. We noted that the other codes in 
related X-ray code families that included clinical labor time for the 
``Greet patient, provide gowning, ensure appropriate medical records 
are available'' (CA009) task included a patient gown, and we are 
proposing to add the patient gown to match the other codes in these 
families. We are also proposing to refine the equipment time for the 
basic radiology room (EL012) in accordance with our standard equipment 
time formulas.
(36) X-Ray Esophagus (CPT Codes 74210, 74220, and 74230)
    CPT code 74220 (Radiologic examination; esophagus) was identified 
on a screen of CMS or Other source codes with Medicare utilization 
greater than 100,000 services annually. CPT codes 74210 (Radiologic 
examination; pharynx and/or cervical esophagus) and 74230 (Swallowing 
function, with cineradiography/videoradiography) were also included for 
review as part of the same family of codes.
    We are proposing the work RVUs recommended by the RUC for the CPT 
codes in this family as follows: A work RVU 0.59 for CPT code 74210 
(Radiologic examination; pharynx and/or cervical esophagus), a work RVU 
of 0.67 for CPT code 74220 (Radiologic examination; esophagus), and a 
work RVU of 0.53 for CPT code 74230 (Swallowing function, with 
cineradiography/videoradiography).
    For the direct PE inputs, we noted that the recommended quantity of 
the Polibar barium suspension (SH016) supply is increasing from 1 ml to 
150 ml for CPT code 74210 and 100 ml are being added to CPT code 74220, 
which did not previously include this supply. The RUC recommendation 
states that this supply quantity increase is due to clinical necessity, 
but does not go into further details about the typical use of the 
supply. Although we are not proposing to refine the quantity of the 
Polibar barium suspension at this time, we are seeking additional 
comment about the typical use of the supply in these procedures. We are 
also proposing to refine the equipment times for all three codes in 
accordance with our standard equipment time formulas.
(37) X-Ray Urinary Tract (CPT Code 74420)
    CPT code 74420 (Urography, retrograde, with or without KUB) was 
identified on a screen of CMS or Other source codes with Medicare 
utilization greater than 100,000 services annually.
    We are proposing the RUC-recommended work RVU of 0.52 for CPT code 
74420 (Urography, retrograde, with or without KUB).
    For the direct PE inputs, we are proposing to remove the 1 minute 
of clinical labor time for the ``Confirm order, protocol exam'' (CA014) 
activity. The clinical labor time recommended for this activity is not 
included in the reference code, nor is it included in any of the two 
dozen other X-ray codes that were reviewed at the same RUC meeting. 
There is also no explanation in the recommended materials as to why 
this clinical labor time would need to be added. We do not believe that 
this clinical labor would be typical for CPT code 74420, and we are 
proposing to remove it to match the rest of the X-ray codes. We are 
also proposing to refine the equipment times in accordance with our 
standard equipment time formulas.
(38) Fluoroscopy (CPT Code 76000)
    CPT code 76000 (Fluoroscopy (separate procedure), up to 1 hour 
physician or other qualified health care professional time) was 
identified on a screen of CMS or Other source codes with Medicare 
utilization greater than 100,000 services annually. CPT code 76001 
(Fluoroscopy, physician or other qualified health care professional 
time more than 1 hour, assisting a nonradiologic physician or other 
qualified health care professional) was

[[Page 35760]]

also included for review as part of the same family of codes. However, 
due to the fact that supervision and interpretation services have been 
increasingly bundled into the underlying procedure codes, the RUC 
concluded that this practice is rare, if not obsolete, and CPT code 
76001 was recommended for deletion by the CPT Editorial Panel for CY 
2019.
    We are proposing the RUC-recommended work RVU of 0.30 for CPT code 
76000 (Fluoroscopy (separate procedure), up to 1 hour physician or 
other qualified health care professional time, other than 71023 or 
71034 (e.g., cardiac fluoroscopy)).
    For the direct PE inputs, we are proposing to refine the equipment 
times in accordance with our standard equipment time formulas.
(39) Echo Exam of Eye Thickness (CPT Code 76514)
    CPT code 76514 (Ophthalmic ultrasound, diagnostic; corneal 
pachymetry, unilateral or bilateral (determination of corneal 
thickness)) was identified as potentially misvalued on a screen of 
codes with a negative intraservice work per unit of time (IWPUT), with 
2016 estimated Medicare utilization over 10,000 for RUC reviewed codes 
and over 1,000 for Harvard-valued and CMS/Other source codes.
    For CPT code 76514, we disagree with the RUC-recommended work RVU 
of 0.17 and we are proposing a work RVU of 0.14. We note that the 
recommended intraservice time for CPT code 76514 is decreasing from 5 
minutes to 3 minutes (40 percent reduction), and the recommended total 
time for CPT code 76514 is decreasing from 15 minutes to 5 minutes (67 
percent reduction); however, the RUC-recommended work RVU is not 
decreasing at all and remains at 0.17. Although we do not imply that 
the decrease in time as reflected in survey values must equate to a 
one-to-one or linear decrease in the valuation of work RVUs, we believe 
that since the two components of work are time and intensity, 
significant decreases in time should be reflected in decreases to work 
RVUs.
    We also note that the RUC recommendations for CPT code 76514 stated 
that, although the steps in the procedure are unchanged since it was 
first valued, the workflow has changed. With the advent of smaller and 
easier to use pachymeters, the technician now typically takes the 
measurements that used to be taken by the practitioner for CPT code 
76514, and the intraservice time was reduced by two minutes to account 
for the technician performing this service. We believe that this change 
in workflow indicates that the work RVU for the code should be reduced 
in some fashion, since some of the work that was previously done by the 
practitioner is now typically performed by the technician. We have no 
reason to believe that there is more intensive cognitive work being 
performed by the practitioner after these measurements are taken since 
the recommendations indicated that the steps in the procedure are 
unchanged since this code was first valued.
    Therefore, we are proposing a work RVU of 0.14 for CPT code 76514, 
which is based on taking half of the intraservice time ratio. We 
considered applying the intraservice time ratio to CPT code 76514, 
which would reduce the work RVU to 0.10 based on taking the change in 
intraservice time (from 5 minutes to 3 minutes) and multiplying this 
ratio of 0.60 times the current work RVU of 0.17. However, we recognize 
that the minutes shifted to the clinical staff were less intense than 
the minutes that remained in CPT code 76514, and therefore, we applied 
half of the intraservice time ratio for a reduction of 0.03 RVUs to 
arrive at a proposed work RVU of 0.14. We believe that this proposed 
value more accurately takes into account the changes in workflow that 
have caused substantial reductions in the surveyed work time for the 
procedure.
    We are not proposing any direct PE refinements for this code 
family.
(40) Ultrasound Elastography (CPT Codes 767X1, 767X2, and 767X3)
    In September 2017, the CPT Editorial Panel created three new codes 
describing the use of ultrasound elastography to assess organ 
parenchyma and focal lesions: CPT codes 767X1 (Ultrasound, 
elastography; parenchyma), 767X2 (Ultrasound, elastography; first 
target lesion) and 767X3 (Ultrasound, elastography; each additional 
target lesion). The most common use of this code set will be for 
preparing patients with disease of solid organs, like the liver, or 
lesions within solid organs.
    The RUC recommended a work RVU of 0.59 for CPT code 767X1 
(Ultrasound, elastography; parenchyma (e.g., organ)), a work RVU of 
0.59 for CPT code 767X2 (Ultrasound, elastography; first target 
lesion), and a work RVU of 0.50 for add-on CPT code 767X3 (Ultrasound, 
elastography; each additional target lesion). We are proposing the RUC- 
recommended work RVUs for each of these new CPT codes.
    For the direct PE inputs, we are proposing to refine the clinical 
labor time for the ``Prepare room, equipment and supplies'' (CA013) 
activity to 3 minutes and to refine the clinical labor time for the 
``Confirm order, protocol exam'' (CA014) activity to 0 minutes for CPT 
codes 767X1 and 767X2. CPT code 76700 (Ultrasound, abdominal, real time 
with image documentation; complete), the reference code for these two 
new codes, did not previously have clinical labor time assigned for the 
``Confirm order, protocol exam'' clinical labor task, and we do not 
have any reason to believe that these particular services being 
furnished by the clinical staff have changed in the new codes, only the 
way in which this clinical labor time has been presented on the PE 
worksheets. We also note that there is no effect on the total clinical 
labor direct costs in these situations, since the same 3 minutes of 
clinical labor time is still being furnished in CPT codes 767X1 and 
767X2. We are also proposing to refine the equipment times in 
accordance with our standard equipment time formulas.
(41) Ultrasound Exam--Scrotum (CPT Code 76870)
    CPT code 76870 (Ultrasound, scrotum and contents) was identified on 
a screen of CMS or Other source codes with Medicare utilization greater 
than 100,000 services annually. We are proposing a work RVU of 0.64 for 
CPT code 76870 (Ultrasound, scrotum and contents), as recommended by 
the RUC.
    For the direct PE inputs, we are proposing to refine the clinical 
labor time for the ``Prepare room, equipment and supplies'' (CA013) 
activity to 3 minutes and to refine the clinical labor time for the 
``Confirm order, protocol exam'' (CA014) activity to 0 minutes. CPT 
code 76870 did not previously have clinical labor time assigned for the 
``Confirm order, protocol exam'' clinical labor task, and we do not 
have any reason to believe that the services being furnished by the 
clinical staff have changed, only the way in which this clinical labor 
time has been presented on the PE worksheets. We also note that there 
is no effect on the total clinical labor direct costs in these 
situations since the same 3 minutes of clinical labor time is still 
being furnished under the CA013 room preparation activity. We are also 
proposing to refine the equipment times in accordance with our standard 
equipment time formulas.
(42) Contrast-Enhanced Ultrasound (CPT Codes 76X0X and 76X1X)
    In September 2017, the CPT Editorial Panel created two new CPT 
codes describing the use of intravenous microbubble agents to evaluate

[[Page 35761]]

suspicious lesions by ultrasound. CPT code 76X0X (Ultrasound, targeted 
dynamic microbubble sonographic contrast characterization (non-
cardiac); initial lesion) is a stand-alone procedure for the evaluation 
of a single target lesion. CPT code 76X1X (Ultrasound, targeted dynamic 
microbubble sonographic contrast characterization (non-cardiac); each 
additional lesion with separate injection) is an add-on code for the 
evaluation of each additional lesion.
    The two new CPT codes in this family represent a new technology 
that involves the use of intravenous microbubble agents to evaluate 
suspicious lesions by ultrasound. The first new CPT code, 76X0X 
(Ultrasound, targeted dynamic microbubble sonographic contrast 
characterization (non-cardiac); initial lesion), is the base code for 
the new add-on CPT code 76X1X (Ultrasound, targeted dynamic microbubble 
sonographic contrast characterization (non-cardiac); each additional 
lesion with separate injection). The RUC reviewed the survey results 
for CPT code 76X0X and recommended total time of 30 minutes and 
intraservice time of 20 minutes. Their recommendation for a work RVU of 
1.62 is based neither on the median of the survey results (1.82) nor 
the 25th percentile of the survey results (1.27). Instead, the RUC-
recommended work RVU is based on a crosswalk to CPT code 73719 
(Magnetic resonance (e.g., proton) imaging, lower extremity other than 
joint; with contrast material(s)), which has identical intraservice and 
total times as the survey CPT code. The RUC also identified a 
comparison CPT code (CPT code 73222 (Magnetic resonance (e.g., proton) 
imaging, any joint of upper extremity; with contrast material(s)) with 
work RVU 1.62 and similar times. For add-on CPT code 76X1X, the RUC 
recommended a work RVU of 0.85, which is the 25th percentile of survey 
results, with total and intraservice times of 15 minutes.
    While we generally agree that, particularly in instances where a 
CPT code represents a new technology or procedure, there may be reason 
to deviate from survey metrics, we are confused by the logic behind the 
RUC's recommendation of a work RVU of 1.62 for CPT code 76X0X. When we 
consider the range of existing CPT codes with 30 minutes total time and 
20 minutes intraservice time, we note that a work RVU of 1.62 is among 
the highest potential crosswalks. We also note that the RUC agreed with 
the 25th percentile of survey results for the new add-on CPT code, 
76X1X, and we do not see why the 25th percentile wouldn't also be 
appropriate for the base CPT code, 76X0X. Therefore, we are proposing a 
work RVU of 1.27 for CPT code 76X0X. We identified two CPT codes with 
total time of 30 minutes and intraservice time of 20 minutes that 
bracket the proposed work RVU of 1.27: CPT code 93975 (Duplex scan of 
arterial inflow and venous outflow of abdominal, pelvic, scrotal 
contents and/or retroperitoneal organs; complete study) has a work RVU 
of 1.16, and CPT code 72270 (Myelography, 2 or more regions (e.g., 
lumbar/thoracic, cervical/thoracic, lumbar/cervical, lumbar/thoracic/
cervical), radiological supervision and interpretation) has a work RVU 
of 1.33. We are proposing the RUC-recommended work RVU of 0.85 for add-
on CPT code 76X1X.
    For the direct PE inputs, we are proposing to refine the clinical 
labor time for the ``Prepare room, equipment and supplies'' (CA013) 
activity to 3 minutes and to refine the clinical labor time for the 
``Confirm order, protocol exam'' (CA014) activity to 0 minutes for CPT 
code 76X0X. CPT codes 76700 (Ultrasound, abdominal, real time with 
image documentation; complete) and 76705 (Ultrasound, abdominal, real 
time with image documentation; limited), the reference codes for this 
new code, did not previously have clinical labor time assigned for the 
``Confirm order, protocol exam'' clinical labor task, and we do not 
have any reason to believe that these particular services being 
furnished by the clinical staff have changed in the new code, only the 
way in which this clinical labor time has been presented on the PE 
worksheets. We also note that there is no effect on the total clinical 
labor direct costs in these situations, since the same 3 minutes of 
clinical labor time is still being furnished in CPT code 76X0X.
    We are proposing to remove the 50 ml of the phosphate buffered 
saline (SL180) for CPT codes 76X0X and 76X1X. When these codes were 
reviewed by the RUC, the conclusion that was reached was to remove this 
supply and replace it with normal saline. Since the phosphate buffered 
saline remained in the recommended direct PE inputs, we believe its 
inclusion may have been a clerical error. We are proposing to remove 
the supply and soliciting comments on the phosphate buffered saline or 
a replacement saline solution. We are also proposing to refine the 
equipment times in accordance with our standard equipment time 
formulas.
(43) Magnetic Resonance Elastography (CPT Code 76X01)
    The CPT Editorial Panel created a new stand-alone code (76X01) 
describing the use of magnetic resonance elastography for the 
evaluation of organ parenchymal pathology. This code will most often be 
used to evaluate patients with disease of solid organs (for example, 
cirrhosis of the liver) or pathology within solid organs that manifest 
with increasing fibrosis or scarring. The goal with magnetic resonance 
elastography is to evaluate the degree of fibrosis/scarring (that is, 
stiffness) without having to perform more invasive procedures (for 
example, biopsy). This technique can be used to characterize the 
severity of parenchymal disease, follow disease progression, or 
response to therapy.
    The RUC recommended a work RVU for new CPT code 76X01 (Magnetic 
resonance (e.g., vibration) elastography) of 1.29, with 15 minutes of 
intraservice time and 25 minutes of total time. The recommendation is 
based on a comparison with two reference CPT codes, CPT code 74183 
(Magnetic resonance (e.g., proton) imaging, abdomen; without contrast 
material(s), followed by with contrast material(s) and further 
sequences) with total time of 40 minutes, intraservice time of 30 
minutes, and a work RVU of 2.20; and CPT code 74181 (Magnetic resonance 
(e.g., proton) imaging, abdomen; without contrast material(s)), which 
has a total time of 30 minutes, intraservice time of 20 minutes, and a 
work RVU of 1.46. The RUC stated that both reference CPT codes have 
higher work values than the new CPT code, which is justified in both 
cases by higher intra-service times. They note that, despite shorter 
intraservice and total time, CPT code 76X01 is slightly more intense to 
perform due to the evaluation of wave propagation images and 
quantitative stiffness measures. We do not agree with the RUC's 
recommended work RVU for this CPT code. Using the RUC's two top 
reference CPT codes as a point of comparison, the intraservice time 
ratio in both instances suggests that a work RVU closer to 1.10 would 
be more appropriate. We recognize that the RUC believes the new CPT 
code is slightly more intense to furnish, but we are concerned about 
the relativity of this code in comparison with other imaging procedures 
that have similar intraservice and total times. Instead of the RUC-
recommended work RVU of 1.29 for CPT code 76X01, we are proposing a 
work RVU of 1.10, which is based on a direct crosswalk to CPT code 
71250 (Computed tomography, thorax; without contrast material). CPT 
code 71250 has identical intraservice time (15 minutes) and total time 
(25 minutes) compared to CPT code 76X01, and we

[[Page 35762]]

believe that the work involved in furnishing both services is similar. 
We note that CPT code 76X01 describes a new technology and will be 
reviewed again by the RUC in 3 years.
    For the direct PE inputs, we are proposing to refine the clinical 
labor time for the ``Prepare room, equipment and supplies'' (CA013) 
activity from 6 minutes to 5 minutes, and for the ``Prepare, set-up and 
start IV, initial positioning and monitoring of patient'' (CA016) 
activity from 4 minutes to 3 minutes. We disagree that this additional 
clinical labor time would be typical for these activities, which are 
already above the standard times for these tasks. In both cases, we 
propose to maintain the current time from the reference CPT code 72195 
(Magnetic resonance (e.g., proton) imaging, pelvis; without contrast 
material(s)) for these clinical labor activities. We are also proposing 
to refine the equipment times in accordance with our standard equipment 
time formulas.
(44) Computed Tomography (CT) Scan for Needle Biopsy (CPT Code 77012)
    CPT code 77012 (Computed tomography guidance for needle placement 
(e.g., biopsy, aspiration, injection, localization device), 
radiological supervision and interpretation) was identified on a screen 
of CMS or Other source codes with Medicare utilization greater than 
100,000 services annually.
    We are proposing the RUC-recommended work RVU of 1.50 for CPT code 
77012 (Computed tomography guidance for needle placement (e.g., biopsy, 
aspiration, injection, localization device), radiological supervision 
and interpretation).
    For the direct PE inputs, we are proposing to refine the clinical 
labor time for the ``Prepare room, equipment and supplies'' (CA013) 
activity to 3 minutes and to refine the clinical labor time for the 
``Confirm order, protocol exam'' (CA014) activity to 0 minutes. CPT 
code 77012 did not previously have clinical labor time assigned for the 
``Confirm order, protocol exam'' clinical labor task, and we do not 
have any reason to believe that the services being furnished by the 
clinical staff have changed, only the way in which this clinical labor 
time has been presented on the PE worksheets. We also note that there 
is no effect on the total clinical labor direct costs in these 
situations since the same 3 minutes of clinical labor time is still 
being furnished under the CA013 room preparation activity.
    We are proposing to refine the equipment time for the CT room 
(EL007) to maintain the current time of 9 minutes. CPT code 77012 is a 
radiological supervision and interpretation procedure and there has 
been a longstanding convention in the direct PE inputs, shared by 38 
other codes, to assign an equipment time of 9 minutes for the equipment 
room in these procedures. We do not believe that it would serve the 
interests of relativity to increase the equipment time for the CT room 
in CPT code 77012 without also addressing the equipment room time for 
the other radiological supervision and interpretation procedures. 
Therefore, we are proposing to maintain the current equipment room time 
of 9 minutes until this group of procedures can be subject to a more 
comprehensive review. We are also proposing to refine the equipment 
time for the Technologist PACS workstation (ED050) in accordance with 
our standard equipment time formulas.
(45) Dual-Energy X-Ray Absorptiometry (CPT Code 77081)
    CPT code 77081 (Dual-energy X-ray absorptiometry (DXA), bone 
density study, 1 or more sites; appendicular skeleton (peripheral) 
(e.g., radius, wrist, heel)) was identified as potentially misvalued on 
a screen of codes with a negative intraservice work per unit of time 
(IWPUT), with 2016 estimated Medicare utilization over 10,000 for RUC 
reviewed codes and over 1,000 for Harvard valued and CMS/Other source 
codes. For CY 2019, we are proposing the RUC-recommended work RVU of 
0.20 for CPT code 77081.
    We are not proposing any direct PE refinements for this code 
family.
(46) Breast MRI With Computer-Aided Detection (CPT Codes 77X49, 77X50, 
77X51, and 77X52)
    CPT codes 77058 (Magnetic resonance imaging, breast, without and/or 
with contrast material(s); unilateral) and 77059 (Magnetic resonance 
imaging, breast, without and/or with contrast material(s); bilateral) 
were identified in 2016 on a high expenditure services screen across 
specialties with Medicare allowed charges of $10 million or more. When 
preparing to survey these codes, the specialties noted that the 
clinical indications had changed for these exams. The technology had 
advanced to make computer-aided detection (CAD) typical and these codes 
did not parallel the structure of other magnetic resonance imaging 
(MRI) codes. In June 2017 the CPT Editorial Panel deleted CPT codes 
0159T, 77058, and 77059 and created four new CPT codes to report breast 
MRI with and without contrast (including computer-aided detection).
    The RUC recommended a work RVU of 1.45 for CPT code 77X49 (Magnetic 
resonance imaging, breast, without contrast material; unilateral). This 
recommendation is based on a comparison with CPT codes 74176 (Computed 
tomography, abdomen and pelvis; without contrast material) and 74177 
(Computed tomography, abdomen and pelvis; with contrast material(s)), 
which both have similar intraservice and total times in relation to CPT 
code 77X49. We disagree with the RUC's recommended work RVU because we 
do not believe that the reduction in total time of 15 minutes between 
the new CPT code 77X49 and the deleted CPT code 74177 is adequately 
reflected in its recommendation. While total time has decreased by 15 
minutes, the only other difference between the two CPT codes is the 
change in the descriptor from the phrase `without and/or with contrast 
material(s)' to `without contrast material,' suggesting that there is 
less work involved in the new CPT code than in the deleted CPT code. 
Instead, we are proposing a work RVU of 1.15 for CPT code 77X49, which 
is similar to the total time ratio between the new CPT code and the 
deleted CPT code. It is also supported by a crosswalk to CPT code 77334 
(Treatment devices, design and construction; complex (irregular blocks, 
special shields, compensators, wedges, molds or casts)). CPT code 77334 
has total time of 35 minutes, intraservice time of 30 minutes, and a 
work RVU of 1.15.
    CPT code 77X50 (Magnetic resonance imaging, breast, without 
contrast material; bilateral) describes the same work as CPT code 
77X49, but reflects a bilateral rather than the unilateral procedure. 
The RUC recommended a work RVU of 1.60 for CPT code 77X50. Since we are 
proposing a different work RVU for the unilateral procedure than the 
value proposed by the RUC, we believe it is appropriate to recalibrate 
the work RVU for CPT code 77X50 relative to the RUC's recommended 
difference in work between the two CPT codes. The RUC's recommendation 
for the bilateral procedure is 0.15 work RVUs larger than for the 
unilateral procedure. Therefore, we are proposing a work RVU of 1.30 
for CPT code 77X50.
    The RUC recommended a work RVU of 2.10 for CPT code 77X51 (Magnetic 
resonance imaging, breast, without and with contrast material(s), 
including computer-aided detection (CAD-real time lesion detection, 
characterization and pharmacokinetic analysis) when performed; 
unilateral). CPT code 77X51 is a new CPT code that bundles the deleted 
CPT code for unilateral breast

[[Page 35763]]

MRI without and/or with contrast material(s) with CAD, which was 
previously reported, in addition to the primary procedure CPT code, as 
CPT code 0159T (computer aided detection, including computer algorithm 
analysis of MRI image data for lesion detection/characterization, 
pharmacokinetic analysis, with further physician review for 
interpretation, breast MRI). Consistent with our belief that the 
proposed value for the base CPT code in this series of new CPT codes 
(CPT code 77X49) should be a work RVU of 1.15, we are proposing a work 
RVU for CPT code 77X51 that adds the RUC-recommended difference in RUC-
recommended work RVUs between CPT codes 77X49 and 77X51 (0.65 work 
RVUs) to the proposed work RVU for CPT code 77X49. Therefore, we are 
proposing a work RVU of 1.80 for CPT code 77X51.
    The last new CPT code in this series, CPT code 77X52 (Magnetic 
resonance imaging, breast, without and with contrast material(s), 
including computer-aided detection (CAD-real time lesion detection, 
characterization and pharmoacokinetic analysis) when performed; 
bilateral) describes the same work as CPT code 77X51, but reflects a 
bilateral rather than a unilateral procedure. The RUC recommended a 
work RVU of 2.30 for this CPT code. Similar to the process for valuing 
work RVUs for CPT code 77X50 and CPT code 77X51, we believe that a more 
appropriate work RVU is calculated by adding the difference in the RUC 
recommended work RVU for CPT codes 77X49 and 77X52, to the proposed 
value for CPT code 77X49. Therefore, we are proposing a work RVU of 
2.00 for CPT code 77X52.
    For the direct PE inputs, we are proposing to refine the clinical 
labor time for the ``Prepare, set-up and start IV, initial positioning 
and monitoring of patient'' (CA016) activity from 7 minutes to 3 
minutes for CPT codes 77X49 and 77X50, and from 9 minutes to 5 minutes 
for CPT codes 77X51 and 77X52. We note that when the MRI of Lower 
Extremity codes were reviewed during the previous rule cycle (CPT codes 
73718-73720), these codes contained either 3 minutes or 5 minutes of 
recommended time for this same clinical labor activity. We also note 
that the current Breast MRI codes that are being deleted and replaced 
with these four new codes, CPT codes 77058 and 77059, contain 5 minutes 
of clinical labor time for this same activity. We have no reason to 
believe that the new codes would require additional clinical labor time 
for patient positioning, especially given that the recommended clinical 
labor times are decreasing in comparison to the reference codes for 
obtaining patient consent (CA011) and preparing the room (CA013). 
Therefore, we are refining the clinical labor time for the CA016 
activity as detailed above to maintain relativity with the current 
clinical labor times in the reference codes, as well as with other 
recently reviewed MRI procedures.
    Included in the recommendations for this code family were five new 
equipment items: CAD Server (ED057), CAD Software (ED058), CAD 
Software--Additional User License (ED059), Breast coil (EQ388), and CAD 
Workstation (CPU + Color Monitor) (ED056). We did not receive any 
invoices for these five equipment items, and as such we do not have any 
direct pricing information to use in their valuation. We are proposing 
to use crosswalks to similar equipment items as proxies for three of 
these new types of equipment until we do have pricing information:
     CAD software (ED058) is crosswalked to flow cytometry 
analytics software (EQ380).
     Breast coil (EQ388) is crosswalked to Breast biopsy device 
(coil) (EQ371).
     CAD Workstation (CPU + Color Monitor) (ED056) is 
crosswalked to Professional PACS workstation (ED053).
    We welcome the submission of invoices with pricing information for 
these three new equipment items for our consideration to replace the 
use of these proxies. For the other two equipment items (CAD Server 
(ED057) and CAD Software--Additional User License (ED059)), we are not 
proposing to establish a price at this time as we believe both of them 
would constitute forms of indirect PE under our methodology. We do not 
believe that the CAD Server or Additional User License would be 
allocated to the use of an individual patient for an individual 
service, and can be better understood as forms of indirect costs 
similar to office rent or administrative expenses. We understand that 
as the PE data age, these issues involving the use of software and 
other forms of digital tools become more complex. However, the use of 
new technology does not change the statutory requirement under which 
indirect PE is assigned on the basis of direct costs that must be 
individually allocable to a particular patient for a particular 
service. We look forward to continuing to seek out new data sources to 
help in updating the PE methodology.
    We are also proposing to refine the equipment times in accordance 
with our standard equipment time formulas.
(47) Blood Smear Interpretation (CPT Code 85060)
    CPT code 85060 (Blood smear, peripheral, interpretation by 
physician with written report) was identified on a screen of CMS or 
Other source codes with Medicare utilization greater than 100,000 
services annually. For CY 2019, the RUC recommended a work RVU of 0.45 
based on maintaining the current work RVU.
    We disagree with the recommended value and are proposing a work RVU 
of 0.36 for CPT code 85060 based on the total time ratio between the 
current time of 15 minutes and the recommended time established by the 
survey of 12 minutes. This ratio equals 80 percent, and 80 percent of 
the current work RVU of 0.45 equals a work RVU of 0.36. When we 
reviewed CPT code 85060, we found that the recommended work RVU was 
higher than nearly all of the other global XXX codes with similar time 
values, and we do not believe that this blood smear interpretation 
procedure would have an anomalously high intensity. Although we do not 
imply that the decrease in time as reflected in survey values must 
equate to a one-to-one or linear decrease in the valuation of work 
RVUs, we believe that since the two components of work are time and 
intensity, significant decreases in time should be reflected in 
decreases to work RVUs. In the case of CPT code 85060, we believe that 
it would be more accurate to propose the total time ratio at a work RVU 
of 0.36 to account for these decreases in the surveyed work time.
    The proposed work RVU is also based on the use of three crosswalk 
codes. We are directly supporting the proposed valuation through a 
crosswalk to CPT code 95930 (Visual evoked potential (VEP) checkerboard 
or flash testing, central nervous system except glaucoma, with 
interpretation and report), which has a work RVU of 0.35 along with 10 
minutes of intraservice time and 14 minutes of total time. We also 
explain the proposed valuation by bracketing it between two other 
crosswalks, with CPT code 99152 (Moderate sedation services provided by 
the same physician or other qualified health care professional 
performing the diagnostic or therapeutic service that the sedation 
supports; initial 15 minutes of intraservice time, patient age 5 years 
or older) on the lower end at a work RVU of 0.25 and CPT code 93923 
(Complete bilateral noninvasive physiologic studies of upper or lower 
extremity arteries, 3 or more levels, or single level study with 
provocative

[[Page 35764]]

functional maneuvers) on the higher end at a work RVU of 0.45.
    The RUC recommended no direct PE inputs for CPT code 85060 and we 
are recommending none.
(48) Bone Marrow Interpretation (CPT Code 85097)
    CPT code 85097 (Bone marrow, smear interpretation) was identified 
on a screen of CMS or Other source codes with Medicare utilization 
greater than 100,000 services annually. For CY 2019, the RUC 
recommended a work RVU of 1.00 based on a direct crosswalk to CPT code 
88121 (Cytopathology, in situ hybridization (e.g., FISH), urinary tract 
specimen with morphometric analysis, 3-5 molecular probes, each 
specimen; using computer-assisted technology).
    We disagree with the RUC-recommended value and we are proposing a 
work RVU of 0.94 for CPT code 85097 based on maintaining the current 
work valuation. We noted that the survey indicated that CPT code 85097 
typically takes 25 minutes of work time to perform, down from a 
previous work time of 30 minutes, and, generally speaking, since the 
two components of work are time and intensity, we believe that 
significant decreases in time should be reflected in decreases to work 
RVUs. For the specific case of CPT code 85097, we are supporting our 
proposed work RVU of 0.94 through a crosswalk to CPT code 88361 
(Morphometric analysis, tumor immunohistochemistry (e.g., Her-2/neu, 
estrogen receptor/progesterone receptor), quantitative or 
semiquantitative, per specimen, each single antibody stain procedure; 
using computer-assisted technology), a recently reviewed code from CY 
2018 with the identical time values and a work RVU of 0.95.
    We also considered a work RVU of 0.90 based on double the 
recommended work RVU of 0.45 for CPT code 85060 (Blood smear, 
peripheral, interpretation by physician with written report). When both 
of these CPT codes were under review, the explanation was offered that 
in a peripheral blood smear, typically, the practitioner does not have 
the approximately 12 precursor cells to review, whereas in an aspirate 
from the bone marrow, the practitioner is examining all the precursor 
cells. Additionally, for CPT code 85097, there are more cell types to 
look at as well as more slides, usually four, whereas with CPT code 
85060 the practitioner would typically only look at one slide. While we 
do not propose to value CPT code 85097 at twice the work RVU of CPT 
code 85060, we believe this analysis also supports maintaining the 
current work RVU of 0.94 as opposed to raising it to 1.00.
    For the direct PE inputs, we are proposing to remove the clinical 
labor time for the ``Accession and enter information'' (PA001) and 
``File specimen, supplies, and other materials'' (PA008) activities. As 
we stated previously, information entry and specimen filing tasks are 
not individually allocable to a particular patient for a particular 
service and are considered to be forms of indirect PE. While we agree 
that these are necessary tasks, under our established methodology we 
believe that they are more appropriately classified as indirect PE.
(49) Fibrinolysins Screen (CPT Code 85390)
    CPT code 85390 (Fibrinolysins or coagulopathy screen, 
interpretation and report) was identified as potentially misvalued on a 
screen of codes with a negative IWPUT, with 2016 estimated Medicare 
utilization over 10,000 for RUC reviewed codes and over 1,000 for 
Harvard valued and CMS/Other source codes. For CY 2019, we are 
proposing the RUC-recommended work RVU of 0.75 for CPT code 85390.
    Because this is a work only code, the RUC did not recommend, and we 
are not proposing any direct PE inputs for CPT code 85390.
(50) Electroretinography (CPT Codes 92X71, 92X73, and 03X0T)
    CPT code 92275 (Electroretinography with interpretation and report) 
was identified in 2016 on a high expenditure services screen across 
specialties with Medicare allowed charges of $10 million or more. In 
January 2016, the specialty society noted that they became aware of 
inappropriate use of CPT code 92275 for a less intensive version of 
this test for diagnosis and indications that are not clinically proven 
and for which less expensive and less intensive tests already exist. 
CPT changes were necessary to ensure that the service for which CPT 
code 92275 was intended was clearly described, as well as an accurate 
vignette and work descriptor were developed. In September 2017, the CPT 
Editorial Panel deleted CPT code 92275 and replaced it with two new 
codes to describe electroretinography full field and multi focal. A 
category III code was retained for pattern electroretinography.
    For CPT code 92X71 (Electroretinography (ERG) with interpretation 
and report; full field (e.g., ffERG, flash ERG, Ganzfeld ERG)), we 
disagree with the recommended work RVU of 0.80 and we are instead 
proposing a work RVU of 0.69 based on a direct crosswalk to CPT code 
88172 (Cytopathology, evaluation of fine needle aspirate; immediate 
cytohistologic study to determine adequacy for diagnosis, first 
evaluation episode, each site). CPT code 88172 is another 
interpretation procedure with the same 20 minutes of intraservice time, 
which we believe is a more accurate comparison for CPT code 92X71 than 
the two reference codes chosen by the survey participants due to their 
significantly higher and lower intraservice times. We note that the 
recommended intraservice time for CPT code 92X71 as compared to its 
predecessor CPT code 92275 is decreasing from 45 minutes to 20 minutes 
(56 percent reduction), and the recommended total time is decreasing 
from 71 minutes to 22 minutes (69 percent reduction); however, the work 
RVU is only decreasing from 1.01 to 0.80, which is a reduction of just 
over 20 percent. Although we do not imply that the decreases in time as 
reflected in survey values must equate to a one-to-one or linear 
decrease in the valuation of work RVUs, we believe that since the two 
components of work are time and intensity, significant decreases in 
time should be reflected in decreases to work RVUs. In the case of CPT 
code 92X71, we have reason to believe that the significant drops in 
surveyed work time as compared to CPT code 92275 are a result of 
improvements in technology since the predecessor code was reviewed. The 
older machines used for electroretinography were slower and more 
cumbersome, and now the same work for the service can be performed in 
significantly less time. Therefore, we are proposing a work RVU of 0.69 
based on the direct crosswalk to CPT code 88172, which we believe more 
accurately accounts for these decreases in surveyed work time.
    For CPT code 92X73 (Electroretinography (ERG) with interpretation 
and report; multifocal (mfERG)), we disagree with the RUC-recommended 
work RVU of 0.72 and are proposing a work RVU of 0.61. We concur that 
the relative difference in work between CPT code 92X71 and 92X73 is 
equivalent to the recommended interval of 0.08 RVUs. Therefore, we are 
proposing a work RVU of 0.61 for CPT code 92X73, based on the 
recommended interval of 0.08 fewer RVUs below our proposed work RVU of 
0.69 for CPT code 92X71. The proposed work RVU is also based on the use 
of two crosswalk codes: CPT code 88387 (Macroscopic examination, 
dissection, and preparation of tissue for

[[Page 35765]]

non-microscopic analytical studies; each tissue preparation); and CPT 
code 92100 (Serial tonometry (separate procedure) with multiple 
measurements of intraocular pressure over an extended time period with 
interpretation and report, same day). Both codes share the same 20 
minutes of intraservice and 20 minutes of total time, with a work RVU 
of 0.62 for CPT code 88387 and a work RVU of 0.61 for CPT code 92100.
    The recommendations for this code family also include Category III 
code 03X0T (Electroretinography (ERG) with interpretation and report, 
pattern (PERG)). We typically assign contractor pricing for Category 
III codes since they are temporary codes assigned to emerging 
technology and services. However, in cases where there is an unusually 
high volume of services that will be performed under a Category III 
code, we have sometimes assigned an active status to the procedure and 
developed RVUs before a formal CPT code is created. In the case of 
Category III code 03X0T, the recommendations indicate that 
approximately 80 percent of the services currently reported under CPT 
code 92275 will be reported under the new Category III code. Since this 
will involve an estimated 100,000 services for CY 2019, we believe that 
the interests of relativity would be better served by assigning an 
active status to Category III code 03X0T and creating RVUs through the 
use of a proxy crosswalk to a similar existing service. Therefore, we 
are proposing to assign an active status to Category III code 03X0T for 
CY 2019, with a work RVU and work time values crosswalked from CPT code 
92250 (Fundus photography with interpretation and report). CPT code 
92250 is a clinically similar procedure that was recently reviewed 
during the CY 2017 rule cycle. We are proposing a work RVU of 0.40 and 
work times of 10 minutes of intraservice and 12 minutes of total time 
for Category III code 03X0T based on this crosswalk to CPT code 92250.
    For the direct PE inputs, we are proposing to remove the preservice 
clinical labor in the facility setting for CPT codes 92X71 and 92X73. 
Both of these codes are diagnostic tests under which the professional 
(26 modifier) and technical (TC modifier) components will be separately 
billable, and codes that have these professional and technical 
components typically will not have direct PE inputs in the facility 
setting since the technical component is only valued in the nonfacility 
setting. We also note on this subject that the predecessor code, CPT 
code 92275, does not currently include any preservice clinical labor, 
nor any facility direct PE inputs.
    We are proposing to remove the clinical labor time for the ``Greet 
patient, provide gowning, ensure appropriate medical records are 
available'' (CA009) and the ``Provide education/obtain consent'' 
(CA011) activities for CPT codes 92X71 and 92X73. Both of these CPT 
codes will typically be reported with a same day E/M service, and we 
believe that these clinical labor tasks will be carried out during the 
E/M service. We believe that their inclusion in CPT codes 92X71 and 
92X73 would be duplicative. We are also proposing to refine the 
clinical labor time for the ``Prepare room, equipment and supplies'' 
(CA013) activity to 3 minutes and to refine the clinical labor time for 
the ``Confirm order, protocol exam'' (CA014) activity to 0 minutes for 
both codes. The predecessor CPT code 92275 did not previously have 
clinical labor time assigned for the ``Confirm order, protocol exam'' 
clinical labor task, and we do not have any reason to believe that the 
services being furnished by the clinical staff have changed in the new 
codes, only the way in which this clinical labor time has been 
presented on the PE worksheets. We also note that there is no effect on 
the total clinical labor direct costs in these situations since the 
same 3 minutes of clinical labor time is still being furnished.
    We are proposing to refine the clinical labor time for the ``Clean 
room/equipment by clinical staff'' (CA024) activity from 12 minutes to 
8 minutes for CPT codes 92X71 and 92X73. The recommendations for these 
codes stated that cleaning is carried out in several steps: The patient 
is first cleaned for 2 minutes, followed by wires and electrodes being 
scrubbed carefully with detergent, soaked, and then rinsed with sterile 
water. We agree with the need for 2 minutes of patient cleaning time 
and for the cleaning of the wires and electrodes to take place in two 
different steps. However, our standard clinical labor time for room/
equipment cleaning is 3 minutes, and therefore, we are proposing a 
total time of 8 minutes for these codes, based on 2 minutes for patient 
cleaning and then 3 minutes for each of the two steps of wire and 
electrode cleaning.
    We are proposing to refine the clinical labor time for the 
``Technologist QC's images in PACS, checking for all images, reformats, 
and dose page'' (CA030) activity from 10 minutes to 3 minutes for CPT 
codes 92X71 and 92X73. We finalized in the CY 2017 PFS final rule (81 
FR 80184-80186) a range of appropriate standard minutes for this 
clinical labor activity, ranging from 2 minutes for simple services up 
to 5 minutes for highly complex services. We believe that the 
complexity of the imaging in CPT codes 92X71 and 92X73 is comparable to 
the CT and magnetic resonance (MR) codes that have been recently 
reviewed, such as CPT code 76X01 (Magnetic resonance (e.g., vibration) 
elastography). Therefore, in order to maintain relativity, we are 
proposing the same clinical labor time of 3 minutes for CPT codes 92X71 
and 92X73 that has been recommended for these CT and MR codes. We are 
also proposing to refine the clinical labor time for the ``Review 
examination with interpreting MD/DO'' (CA031) activity from 5 minutes 
to 2 minutes for CPT codes 92X71 and 92X73. We also finalized in the CY 
2017 PFS final rule a standard time of 2 minutes for reviewing 
examinations with the interpreting MD, and we have no reason to believe 
that these codes would typically require additional clinical labor at 
more than double the standard time.
    We noted that the new equipment item ``Contact lens electrode for 
mfERG and ffERG'' (EQ391) was listed twice for CPT code 92X71 but only 
a single time for CPT code 92X73. We are seeking additional information 
about whether the recommendations intended this equipment item to be 
listed twice, with one contact intended for each eye, or whether this 
was a clerical mistake. We are also interested in additional 
information as to why the contact lens electrode was listed twice for 
CPT code 92X71 but only a single time for CPT code 92X73. Finally, we 
are also proposing to refine the equipment times in accordance with our 
standard equipment time formulas.
    We are proposing to use the direct PE inputs for CPT code 92X73, 
including the refinements detailed above, as a proxy for Category III 
code 03X0T until it can be separately reviewed by the RUC.
(51) Cardiac Output Measurement (CPT Codes 93561 and 93562)
    CPT codes 93561 (Indicator dilution studies such as dye or 
thermodilution, including arterial and/or venous catheterization; with 
cardiac output measurement) and 93562 (Indicator dilution studies such 
as dye or thermodilution, including arterial and/or venous 
catheterization; subsequent measurement of cardiac output) were 
identified as potentially misvalued on a screen of codes with a 
negative IWPUT, with 2016 estimated Medicare utilization over 10,000 
for RUC reviewed codes and over 1,000 for

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Harvard valued and CMS/Other source codes. The specialty societies 
noted that CPT codes 93561 and 93562 are primarily performed in the 
pediatric population, thus the Medicare utilization for these Harvard-
source services is not over 1,000. However, the specialty societies 
requested and the RUC agreed that these services should be reviewed 
under this negative IWPUT screen.
    For CPT code 93561, we disagree with the RUC-recommended work RVU 
of 0.95 and we are proposing a work RVU of 0.60 based on a crosswalk to 
CPT code 77003 (Fluoroscopic guidance and localization of needle or 
catheter tip for spine or paraspinous diagnostic or therapeutic 
injection procedures (epidural or subarachnoid)). CPT Code 77003 is 
another recently-reviewed add-on global code with the same 15 minutes 
of intraservice time and 2 additional minutes of preservice evaluation 
time. In our review of CPT code 93561, we found that there was a 
particularly unusual relationship between the surveyed work times and 
the RUC-recommended work RVU. We noted that the recommended 
intraservice time for CPT code 93561 is decreasing from 29 minutes to 
15 minutes (48 percent reduction), and the recommended total time for 
CPT code 93561 is decreasing from 78 minutes to 15 minutes (81 percent 
reduction); however, the recommended work RVU is instead increasing 
from 0.25 to 0.95, which is an increase of nearly 300 percent. Although 
we do not imply that the decrease in time as reflected in survey values 
must equate to a one-to-one or linear decrease in the valuation of work 
RVUs, we believe that since the two components of work are time and 
intensity, significant decreases in time should typically be reflected 
in decreases to work RVUs, not increases in valuation. We recognize 
that CPT code 93561 is an unusual case, as it is shifting from 0-day 
global status to add-on code status. However, when the work time for a 
code is going down and the unit of service is being reduced, we would 
not expect to see an increased work RVU under these circumstances, and 
especially not such a large work RVU increase. Therefore, we are 
proposing instead to crosswalk CPT code 93561 to CPT code 77003 at a 
work RVU of 0.60, which we believe is a more accurate valuation in 
relation to other recently-reviewed add-on codes on the PFS. We believe 
that this proposed work RVU of 0.60 better preserves relativity with 
other clinically similar codes with similar surveyed work times.
    For CPT code 93562, we disagree with the recommended work RVU of 
0.77 and are proposing a work RVU of 0.48 based on the intraservice 
time ratio with CPT code 93561. We observed a similar pattern taking 
place with CPT code 93562 as with the first code in the family, noting 
that the recommended intraservice time is decreasing from 16 minutes to 
12 minutes (25 percent reduction), and the recommended total time is 
decreasing from 44 minutes to 12 minutes (73 percent reduction); 
however, the RUC-recommended work RVU is instead increasing from 0.01 
to 0.77. We recognize that CPT code 93562 is another unusual case, as 
it is also shifting from 0-day global status to add-on code status, and 
the current work RVU of 0.01 was a decrease from the code's former 
valuation of 0.16 following the removal of moderate sedation in the CY 
2017 rule cycle. However, when the work time for a code is going down 
and the unit of service is being reduced, we typically would not expect 
to see a work RVU increase under these circumstances, and especially 
not such a large work RVU increase. Therefore, we are proposing instead 
to apply the intraservice time ratio from CPT code 93561, for a ratio 
of 0.80 (12 minutes divided by 15 minutes) multiplied by the proposed 
work RVU of 0.60 for CPT code 93561, which results in the proposed work 
RVU of 0.48 for CPT code 93562. We note that the RUC-recommended work 
values also line up according to the same intraservice time ratio, with 
the recommended work RVU of 0.77 for CPT code 93562 existing in a ratio 
of 0.81 with the recommended work RVU of 0.95 for CPT code 93561. We 
believe that this provides further rationale for our proposal to value 
the work RVU of CPT code 93562 at 80 percent of the work RVU of CPT 
code 93561.
    There are no recommended direct PE inputs for the codes in this 
family and we are not proposing any direct PE inputs.
(52) Coronary Flow Reserve Measurement (CPT Codes 93571 and 93572)
    CPT code 93571 (Intravascular Doppler velocity and/or pressure 
derived coronary flow reserve measurement (coronary vessel or graft) 
during coronary angiography including pharmacologically induced stress; 
initial vessel) was identified on a list of all services with total 
Medicare utilization of 10,000 or more that have increased by at least 
100 percent from 2009 through 2014. CPT code 93572 (Intravascular 
Doppler velocity and/or pressure derived coronary flow reserve 
measurement (coronary vessel or graft) during coronary angiography 
including pharmacologically induced stress; each additional vessel) was 
also included for review as part of the same family of CPT codes. The 
RUC recommended a work RVU of 1.50 for CPT code 93571, which is lower 
than the current work RVU of 1.80. The total time for this service 
decreased by 5 minutes from 20 minutes to 15 minutes. The RUC's 
recommendation is based on a crosswalk to CPT code 15136 (Dermal 
autograft, face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, 
hands, feet, and/or multiple digits; each additional 100 sq cm, or each 
additional 1% of body area of infants and children, or part thereof), 
which has an identical intraservice and total time as CPT code 93571 of 
15 minutes. We disagree with the recommended work RVU of 1.50 for this 
CPT code because we do not believe that a reduction in work RVU from 
1.80 to 1.50 is commensurate with the reduction in time for this 
service of five minutes. Using the building block methodology, we 
believe the work RVU for CPT code 93571 should be 1.35. We believe that 
a crosswalk to CPT code 61517 (Implantation of brain intracavitary 
chemotherapy agent (List separately in addition to CPT code for primary 
procedure)) with a work RVU of 1.38 is more appropriate because it has 
an identical intraservice and total time (15 minutes) as CPT code 
93571, describes work that is similar, and is closer to the 
calculations for intraservice time ratio, total time ratio, and the 
building block method. Therefore, we are proposing a work RVU of 1.38 
for CPT code 93571.
    We are proposing the RUC-recommended work RVU for CPT code 93572 
(Intravascular Doppler velocity and/or pressure derived coronary flow 
reserve measurement (coronary vessel or graft) during coronary 
angiography including pharmacologically induced stress; each additional 
vessel) of 1.00.
    Both of these codes are facility-only procedures with no 
recommended direct PE inputs.
(53) Peripheral Artery Disease (PAD) Rehabilitation (CPT Code 93668)
    During 2017, we issued a national coverage determination (NCD) for 
Medicare coverage of supervised exercise therapy (SET) for the 
treatment of peripheral artery disease (PAD). Previously, the service 
had been assigned noncovered status under the PFS. CPT code 93668 
(Peripheral arterial disease (PAD) rehabilitation, per session) was 
payable before the end of CY 2017, retroactive to the effective date of 
the NCD (May 25, 2017), and for CY 2018, CMS made payment for Medicare-
covered SET for the treatment of PAD,

[[Page 35767]]

consistent with the NCD, reported with CPT code 93668. We used the most 
recent RUC-recommended work and direct PE inputs and requested that the 
RUC review the service, which had not been reviewed since 2001, for 
direct PE inputs. The RUC is not recommending a work RVU for CPT code 
93668 due to the belief that there is no physician work involved in 
this service. After reviewing this code, we are proposing a work RVU of 
0.00 for CPT code 93668 and are proposing to continue valuing the code 
for PE only.
(54) Home Sleep Apnea Testing (CPT Codes 95800, 95801, and 95806)
    CPT codes 95800 (Sleep study, unattended, simultaneous recording; 
heart rate, oxygen saturation, respiratory analysis (e.g., by airflow 
or peripheral arterial tone), and sleep time), 95801 (Sleep study, 
unattended, simultaneous recording; minimum of heart rate, oxygen 
saturation, and respiratory analysis (e.g., by airflow or peripheral 
arterial tone)), and 95806 (Sleep study, unattended, simultaneous 
recording of, heart rate, oxygen saturation, respiratory airflow, and 
respiratory effort (e.g., thoracoabdominal movement)) were flagged by 
the CPT Editorial Panel and reviewed at the October 2014 Relativity 
Assessment Workgroup meeting. Due to rapid growth in service volume, 
the RUC recommended that these services be reviewed after 2 more years 
of Medicare utilization data (2014 and 2015 data). These three codes 
were surveyed for the April 2017 RUC meeting and new recommendations 
for work and direct PE inputs were submitted to CMS.
    For CPT code 95800, the RUC recommended a work RVU of 1.00 based on 
the survey 25th percentile value. We disagree with the recommended 
value and are proposing a work RVU of 0.85 based on a pair of crosswalk 
codes: CPT code 93281 (Programming device evaluation (in person) with 
iterative adjustment of the implantable device to test the function of 
the device and select optimal permanent programmed values with 
analysis, review and report by a physician or other qualified health 
care professional; multiple lead pacemaker system) and CPT code 93260 
(Programming device evaluation (in person) with iterative adjustment of 
the implantable device to test the function of the device and select 
optimal permanent programmed values with analysis, review and report by 
a physician or other qualified health care professional; implantable 
subcutaneous lead defibrillator system). Both of these codes have a 
work RVU of 0.85, as well as having the same intraservice time of 15 
minutes, similar total times to CPT code 95800, and recent review dates 
within the last few years.
    In reviewing CPT code 95800, we noted that the recommended 
intraservice time is decreasing from 20 minutes to 15 minutes (25 
percent reduction), and the recommended total time is decreasing from 
50 minutes to 31 minutes (38 percent reduction); however, the RUC-
recommended work RVU is only decreasing from 1.05 to 1.00, which is a 
reduction of less than 5 percent. Although we do not imply that the 
decrease in time as reflected in survey values must equate to a one-to-
one or linear decrease in the valuation of work RVUs, we believe that 
since the two components of work are time and intensity, significant 
decreases in time should be reflected in decreases to work RVUs. In the 
case of CPT code 95800, we believe that it would be more accurate to 
propose a work RVU of 0.85 based on the aforementioned crosswalk codes 
to account for these decreases in the surveyed work time. We also note 
that in this case where the surveyed times are decreasing and the 
utilization of CPT code 95800 is increasingly significantly 
(quadrupling in the last 5 years), we have reason to believe that 
practitioners are becoming more efficient at performing the procedure, 
which, under the resource-based nature of the RVU system, lends further 
support for a reduction in the work RVU.
    For CPT code 95801, the RUC proposed a work RVU of 1.00 again based 
on the survey 25th percentile. We disagree with the recommended value 
and we are again proposing a work RVU of 0.85 based on the same pair of 
crosswalk codes, CPT codes 93281 and 93260. We noted that CPT codes 
95800 and 95801 had identical recommended work RVUs and identical 
recommended survey work times. Given that these two codes also have 
extremely similar work descriptors, we interpreted this to mean that 
the two codes could have the same work RVU, and therefore, we are 
proposing the same work RVU of 0.85 for both codes.
    For CPT code 95806, the RUC recommended a work RVU of 1.08 based on 
a crosswalk to CPT code 95819 (Electroencephalogram (EEG); including 
recording awake and asleep). Although we disagree with the RUC-
recommended work RVU of 1.08, we concur that the relative difference in 
work between CPT codes 95800 and 95801 and CPT code 95806 is equivalent 
to the recommended interval of 0.08 RVUs. Therefore, we are proposing a 
work RVU of 0.93 for CPT code 95806, based on the recommended interval 
of 0.08 additional RVUs above our proposed work RVU of 0.85 for CPT 
codes 95800 and 95801. We also note that CPT code 95806 is experiencing 
a similar change in the recommended work and time values comparable to 
CPT code 95800. The recommended intraservice time for CPT code 95806 is 
decreasing from 25 minutes to 15 minutes (40 percent), and the 
recommended total time is decreasing from 50 minutes to 31 minutes (38 
percent); however, the recommended work RVU is only decreasing from 
1.25 to 1.08, which is a reduction of only 14 percent. As we stated for 
CPT code 95800, we do not believe that decreases in work time must 
equate to a one-to-one or linear decrease in the valuation of work 
RVUs, but we do believe that these changes in surveyed work time 
suggest that practitioners are becoming more efficient at performing 
the procedure, and that it would be more accurate to maintain the 
recommended work interval with CPT codes 95800 and 95801 by proposing a 
work RVU of 0.93 for CPT code 95806.
    We are not proposing any direct PE refinements for this code 
family.
(55) Neurostimulator Services (CPT Codes 95970, 95X83, 95X84, 95X85, 
and 95X86)
    In October 2013, CPT code 95971 (Electronic analysis of implanted 
neurostimulator pulse generator system; simple spinal cord, or 
peripheral (i.e., peripheral nerve, sacral nerve, neuromuscular) 
neurostimulator pulse generator/transmitter, with intraoperative or 
subsequent programming) was identified in the second iteration of the 
High Volume Growth screen. In January 2014, the RUC recommended that 
CPT codes 95971, 95972 (Electronic analysis of implanted 
neurostimulator pulse generator system; complex spinal cord, or 
peripheral (i.e., peripheral nerve, sacral nerve, neuromuscular) 
(except cranial nerve) neurostimulator pulse generator/transmitter, 
with intraoperative or subsequent programming) and 95974 (Electronic 
analysis of implanted neurostimulator pulse generator system; complex 
cranial nerve neurostimulator pulse generator/transmitter, with 
intraoperative or subsequent programming, with or without nerve 
interface testing, first hour) be referred to the CPT Editorial Panel 
to address the entire family regarding the time referenced in the CPT 
code descriptors. In June 2017, the CPT Editorial Panel revised CPT 
codes 95970, 95971, and 95972, deleted CPT codes 95974, 95975 
(Electronic analysis of implanted neurostimulator pulse

[[Page 35768]]

generator system; complex cranial nerve neurostimulator pulse 
generator/transmitter, with intraoperative or subsequent programming, 
each additional 30 minutes after first hour), 95978 (Electronic 
analysis of implanted neurostimulator pulse generator system, complex 
deep brain neurostimulator pulse generator/transmitter, with initial or 
subsequent programming; first hour), and 95979 (Electronic analysis of 
implanted neurostimulator pulse generator system, complex deep brain 
neurostimulator pulse generator/transmitter, with initial or subsequent 
programming; each additional 30 minutes after first hour) and created 
four new CPT codes for analysis and programming of implanted cranial 
nerve neurostimulator pulse generator, analysis, and programming of 
brain neurostimulator pulse generator systems and analysis of stored 
neurophysiology recording data.
    The RUC recommended a work RVU of 0.45 for CPT code 95970 
(Electronic analysis of implanted neurostimulator pulse generator/
transmitter (e.g., contact group(s), interleaving, amplitude, pulse 
width, frequency (Hz), on/off cycling, burst, magnet mode, dose 
lockout, patient selectable parameters, responsive neurostimulation, 
detection algorithms, closed loop parameters, and passive parameters by 
physician or other qualified health care professional; with brain, 
cranial nerve, spinal cord, peripheral nerve, or sacral nerve 
neurostimulator pulse generator/transmitter, without programming)), 
which is identical to the current work RVU for this CPT code. The 
descriptor for this CPT code has been modified slightly, but the 
specialty societies affirmed that the work itself has not changed. To 
justify its recommendation, the RUC provided two references: CPT code 
62368 (Electronic analysis of programmable, implanted pump for 
intrathecal or epidural drug infusion (includes evaluation of reservoir 
status, alarm status, drug prescription status); with reprogramming), 
with intraservice time of 15 minutes, total time of 27 minutes, and a 
work RVU of 0.67; and CPT code 99213 (Office or other outpatient visit 
for the evaluation and management of an established patient, which 
requires at least 2 of these 3 key components: An expanded problem 
focused history; An expanded problem focused examination; or Medical 
decision making of low complexity. Counseling and coordination of care 
with other physicians, other qualified health care professionals, or 
agencies are provided consistent with the nature of the problem(s) and 
the patient's and/or family's needs. Usually, the presenting problem(s) 
are of low to moderate severity. Typically, 15 minutes are spent face-
to-face with the patient and/or family), with intraservice time of 15 
minutes, total time of 23 minutes, and a work RVU of 0.97. We disagree 
with the RUC's recommendation because we do not believe that 
maintaining the work RVU, given a decrease of four minutes in total 
time, is appropriate. In addition, we note that the reference CPT codes 
chosen have much higher intraservice and total times than CPT code 
95970, and also have higher work RVUs, making them poor comparisons. 
Instead, we identified a crosswalk to CPT code 95930 (Visual evoked 
potential (VEP) checkerboard or flash testing, central nervous system 
except glaucoma, with interpretation and report) with 10 minutes 
intraservice time, 14 minutes total time, and a work RVU of 0.35. 
Therefore, we are proposing a work RVU of 0.35 for CPT code 95970.
    CPT code 95X83 (Electronic analysis of implanted neurostimulator 
pulse generator/transmitter (e.g., contact group(s), interleaving, 
amplitude, pulse width, frequency (Hz), on/off cycling, burst, magnet 
mode, dose lockout, patient selectable parameters, responsive 
neurostimulation, detection algorithms, closed loop parameters, and 
passive parameters) by physician or other qualified health care 
professional; with simple cranial nerve neurostimulator pulse 
generator/transmitter programming by physician or other qualified 
health care professional) is a new CPT code replacing CPT code 95974 
(Electronic analysis of implanted neurostimulator pulse generator 
system (e.g., rate, pulse amplitude, pulse duration, configuration of 
wave form, battery status, electrode selectability, output modulation, 
cycling, impedance and patient compliance measurements); complex 
cranial nerve neurostimulator pulse generator/transmitter, with 
intraoperative or subsequent programming, with or without nerve 
interface testing, first hour). The description of the work involved in 
furnishing CPT code 95X83 differs from that of the deleted CPT code in 
a few important ways, notably that the time parameter has been removed 
so that the CPT code no longer describes the first hour of programming. 
In addition, the new CPT code refers to simple rather than complex 
programming. Accordingly, the intraservice and total times for this CPT 
code are substantively different from those of the deleted CPT code. 
CPT code 95X83 has an intraservice time of 11 minutes and a total time 
of 24 minutes, while CPT code 95974 has an intraservice time of 60 
minutes and a total time of 110 minutes. The RUC recommended a work RVU 
of 0.95 for CPT code 95X83. The RUC's top reference CPT code as chosen 
by the RUC survey participants was CPT code 95816 (Electroencephalogram 
(EEG); including recording awake and drowsy), with an intraservice time 
of 15 minutes, 26 minutes total time, and a work RVU of 1.08. The RUC 
indicated that the service is similar, but somewhat more complex than 
CPT code 95X83. We disagree with the RUC's recommended work RVU for 
this CPT code because we do not believe that the large difference in 
time between the new CPT code and CPT code 95974 is reflected in the 
slightly smaller proportional decrease in work RVUs. The reduction in 
total time, from 110 minutes to 24 minutes is nearly 80 percent. 
However, the RUC's recommended work RVU reflects a reduction of just 
under 70 percent. We believe that a more appropriate crosswalk would be 
CPT code 76641 (Ultrasound, breast, unilateral, real time with image 
documentation, including axilla when performed; complete) with 
intraservice time of 12 minutes, total time of 22 minutes, and a work 
RVU of 0.73. Therefore, we are proposing a work RVU of 0.73 for CPT 
code 95X83.
    CPT code 95X84 describes the same work as CPT code 95X83, but with 
complex rather than simple programming. The CPT Editorial Panel refers 
to simple programming of a neurostimulator pulse generator/transmitter 
as the adjustment of one to three parameter(s), while complex 
programming includes adjustment of more than three parameters. For 
purposes of applying the building block methodology and calculating 
intraservice and total time ratios, the RUC compared CPT code 94X84 
with CPT code 95975 (Electronic analysis of implanted neurostimulator 
pulse generator system (e.g., rate, pulse amplitude, pulse duration, 
configuration of wave form, battery status, electrode selectability, 
output modulation, cycling, impedance and patient compliance 
measurements); complex cranial nerve neurostimulator pulse generator/
transmitter, with intraoperative or subsequent programming, each 
additional 30 minutes after first hour), which is being deleted by the 
CPT Editorial Panel. We believe that this was an inappropriate 
comparison since it is time based (first hour of programming) and is an 
add-on code. Instead we believe that the RUC

[[Page 35769]]

intended to compare CPT code 95X84 with CPT code 95974 (Electronic 
analysis of implanted neurostimulator pulse generator system (e.g., 
rate, pulse amplitude, pulse duration, configuration of wave form, 
battery status, electrode selectability, output modulation, cycling, 
impedance and patient compliance measurements); complex cranial nerve 
neurostimulator pulse generator/transmitter, with intraoperative or 
subsequent programming, with or without nerve interface testing, first 
hour), which has been recommended for deletion by the CPT Editorial 
Panel and is also the comparison for CPT code 95X83. The RUC 
recommended a work RVU of 1.19 for CPT code 95X84. The RUC disagreed 
with the two top reference services CPT code 99215 (Office or other 
outpatient visit for the evaluation and management of an established 
patient, which requires at least 2 of these 3 key components: A 
comprehensive history; A comprehensive examination; or Medical decision 
making of high complexity. Counseling and/or coordination of care with 
other physicians, other qualified health care professionals, or 
agencies are provided consistent with the nature of the problem(s) and 
the patient's and/or family's needs. Usually, the presenting problem(s) 
are of moderate to high severity. Typically, 40 minutes are spent face-
to-face with the patient and/or family) and CPT code 99202 (Office or 
other outpatient visit for the evaluation and management of a new 
patient, which requires these 3 key components: An expanded problem 
focused history; An expanded problem focused examination; or 
straightforward medical decision making. Counseling and/or coordination 
of care with other physicians, other qualified health care 
professionals, or agencies are provided consistent with the nature of 
the problem(s) and the patient's and/or family's needs. Usually, the 
presenting problem(s) are of low to moderate severity. Typically, 20 
minutes are spent face-to-face with the patient and/or family) and 
instead compared CPT code 95X84 to CPT code 99308 (Subsequent nursing 
facility care, per day, for the evaluation and management of a patient, 
which requires at least 2 of these 3 key components: An expanded 
problem focused interval history; An expanded problem focused 
examination; or Medical decision making of low complexity. Counseling 
and/or coordination of care with other physicians, other qualified 
health care professionals, or agencies are provided consistent with the 
nature of the problem(s) and the patient's and/or family's needs. 
Usually, the patient is responding inadequately to therapy or has 
developed a minor complication. Typically, 15 minutes are spent at the 
bedside and on the patient's facility floor or unit.) with total time 
of 31 minutes, intraservice time of 15 minutes, and a work RVU of 1.16; 
and CPT code 12013 (Simple repair of superficial wounds of face, ears, 
eyelids, nose, lips and/or mucous membranes; 2.6 cm to 5.0 cm), with 
total time of 27 minutes, intraservice time of 15 minutes, and a work 
RVU of 1.22. We disagree with the RUC's recommended work RVU of 1.19 
for CPT code 95X84. Once the comparison CPT code is corrected to CPT 
code 95974, the reverse building block calculation indicates that a 
lower work RVU (close to 0.82) would be a better reflection of the work 
involved in furnishing this service. As an alternative to the RUC's 
recommendation, we added the difference in RUC-recommended work RVUs 
between CPT code 95X83 and 95X84 (0.24 RVUs) to the proposed work RVU 
of 0.73 for CPT code 95X83. Therefore, we propose a work RVU of 0.97 
for CPT code 95X84.
    CPT code 95X85 (Electronic analysis of implanted neurostimulator 
pulse generator/transmitter (e.g., contact group(s), interleaving, 
amplitude, pulse width, frequency (Hz), on/off cycling, burst, magnet 
mode, doe lockout, patient selectable parameters, responsive 
neurostimulation, detection algorithms, closed loop parameters, and 
passive parameters) by physician or other qualified health care 
professional; with brain neurostimulator pulse generator/transmitter 
programming, first 15 minutes face-to-face time with physician or other 
qualified health care professional) is the base for add-on CPT code 
95X86 (Electronic analysis of implanted neurostimulator pulse 
generator/transmitter (e.g., contact group(s), interleaving, amplitude, 
pulse width, frequency (Hz), on/off cycling, burst, magnet mode, doe 
lockout, patient selectable parameters, responsive neurostimulation, 
detection algorithms, closed loop parameters, and passive parameters) 
by physician or other qualified health care professional; with brain 
neurostimulator pulse generator/transmitter programming, each 
additional 15 minutes face-to-face time with physician or other 
qualified health care professional), which is an add-on CPT code and 
can only be billed with CPT code 95X85. The RUC compared CPT code 95X85 
with CPT code 95978 (Electronic analysis of implanted neurostimulator 
pulse generator system (e.g., rate, pulse amplitude and duration, 
battery status, electrode selectability and polarity, impedance and 
patient compliance measurements), complex deep brain neurostimulator 
pulse generator/transmitter, with initial or subsequent programming; 
first hour), which the CPT Editorial Panel is recommending for 
deletion. The primary distinction between the new and old CPT codes is 
that the new CPT code describes the first 15 minutes of programming 
while the deleted CPT code describes up to one hour of programming. The 
RUC recommended a work RVU of 1.25 for CPT code 95X85 and a work RVU of 
1.00 for CPT code 95X86. For CPT code 95X85, the RUC's recommendation 
is based on reference CPT codes 12013 (Simple repair of superficial 
wounds of face, ears, eyelids, nose, lips and/or mucous membranes; 2.6 
cm to 5.0 cm), with total time of 27 minutes, intraservice time of 15 
minutes, and a work RVU of 1.22; and CPT code 70470 (Computed 
tomography, head or brain; without contrast material, followed by 
contrast material(s) and further sections) with 25 minutes of total 
time, 15 minutes of intraservice time, and a work RVU of 1.27. We 
disagree with the RUC's recommended work RVU for CPT code 95X85 because 
we do not believe that the reduction in work RVU reflects the change in 
time described by the CPT code. Using the reverse building block 
methodology, we estimate that a work RVU of nearer to 1.11 would be 
more appropriate. In addition, if we were to sum the RUC-recommended 
RVUs for a single hour of programming using one of the base CPT codes 
and three of the 15 minute follow-on CPT codes, 1 hour of programming 
would be valued at 4.25 work RVUs. This contrasts sharply from the work 
RVU of 3.50 for 1 hour of programming using the deleted CPT code 95978. 
We believe that a more appropriate valuation of the work involved in 
furnishing this service is reflected by a crosswalk to CPT code 93886 
(Transcranial Doppler study of the intracranial arteries; complete 
study), with total time 27 minutes, intraservice time of 17 minutes, 
and a work RVU of 0.91. Therefore, we are proposing a work RVU of 0.91 
for CPT code 95X85.
    The RUC's recommended work RVU of 1.00 for CPT code 95X86 is based 
on the key reference service CPT code 64645 (Chemodenervation of one 
extremity; each additional extremity, 5 or more muscles), which has 
total time of 26 minutes, intraservice time of 25 minutes, and a work 
RVU 1.39. This new CPT code is replacing CPT code 95978 (Electronic 
analysis of implanted

[[Page 35770]]

neurostimulator pulse generator system (e.g., rate, pulse amplitude and 
duration, battery status, electrode selectability and polarity, 
impedance and patient compliance measurements), complex deep brain 
neurostimulator pulse generator/transmitter, with initial or subsequent 
programming; first hour), which is being deleted by the CPT Editorial 
Panel. If we add the incremental difference between CPT codes 95X85 and 
95X86 to the proposed value for the base CPT code (95X85, work RVU = 
0.91), we estimate that this add-on CPT code should have a work RVU of 
0.75. The building block methodology results in a recommendation of a 
slightly higher work RVU of 0.82. We are proposing a work RVU of 0.80 
for CPT code 95X86, which falls between the calculated value using 
incremental differences and the calculation from the reverse building 
block, and is supported by a crosswalk to CPT code 51797 (Voiding 
pressure studies, intra-abdominal (i.e., rectal, gastric, 
intraperitoneal)), which is an add-on CPT code with identical total and 
intraservice times (15 minutes) as CPT code 95X86.
    We are not proposing any direct PE refinements for this code 
family.
(56) Psychological and Neuropsychological Testing (CPT Codes 96105, 
96110, 96116, 96125, 96127, 963X0, 963X1, 963X2, 963X3, 963X4, 963X5, 
963X6, 963X7, 963X8, 963X9, 96X10, 96X11, 96X12)
    In CY 2016, the Psychological and Neuropsychological Testing family 
of codes were identified as potentially misvalued using a high 
expenditure services screen across specialties with Medicare allowed 
charges of $10 million or more. The entire family of codes was referred 
to the CPT Editorial Panel to be revised, as the testing practices had 
been significantly altered by the growth and availability of 
technology, leading to confusion about how to report the codes. In June 
2017, the CPT Editorial Panel revised five existing codes, added 13 
codes to provide better description of psychological and 
neuropsychological testing, and deleted CPT codes 96101, 96102, 96103, 
96111, 96118, 96119, and 96120. The RUC and HCPAC submitted 
recommendations for the 13 new codes and for the existing CPT codes 
96105, 96110, 96116, 96125, and 96127.
    We are proposing the RUC- and HCPAC-recommend work RVUs for several 
of the CPT codes in this family: A work RVU of 1.75 for CPT code 96105; 
a work RVU of 1.86 for CPT code 96116; a work RVU of 1.70 for CPT code 
96125; a work RVU of 1.71 for CPT code 963X2; a work RVU of 0.55 for 
CPT code 963X7; a work RVU of 0.46 for CPT code 963X8; and a work RVU 
of 0.51 for CPT code 96X11. CPT codes 96110, 96127, 963X9, 96X10, and 
96X12 were valued by the RUC for PE only.
    This code family contains a subset of codes that describe 
psychological and neuropsychological testing administration and 
evaluation, not including assessment of aphasia, developmental 
screening, or developmental testing. The CPT Editorial Panel's 
recommended coding for this subset of services consists of seven new 
codes: Two that describe either psychological or neuropsychological 
testing when administered by physicians or other qualified health 
professionals (CPT codes 963X7 and 963X8), and two for either type of 
testing when administered by technicians (CPT codes 963X9 and 96X10); 
and four new codes that describe testing evaluation by physicians or 
other qualified health care professionals (CPT codes 963X3-963X6). This 
new coding effectively unbundles codes that currently report the full 
course of testing into separate codes for testing administration (CPT 
codes 963X7, 963X8, 963X9, and 96X10) and evaluation (CPT Codes 963X3, 
963X4, and 963X5). According to a stakeholder that represents the 
psychologist and neuropsychologist community, this new coding will 
result in significant reductions in payment for these services due to 
the unbundling of the testing codes into codes for physician-
administered tests and technician-administered tests. The stakeholder 
asserts that because the new coding includes testing codes with zero 
work RVUs for the technician administered tests and the work RVUs are 
lower than they believe to be accurate, this new valuation would ignore 
the clinical evaluation and decision making performed by the physician 
or other qualified health professional during the course of testing 
administration and evaluation. Furthermore, the net result of the code 
valuations for these new codes is a reduction in the overall work RVUs 
for this family of codes. In other words, the stakeholder's analysis 
found that the RUC recommendations result in a reduction in total work 
RVUs, even though the actual physician work of a testing battery has 
not changed.
    In the interest of payment stability for these high-volume 
services, we are proposing to implement work RVUs for this code family, 
which would eliminate the approximately 2 percent reduction in work 
spending. We are proposing to achieve work neutrality for this code 
family by scaling the work RVUs upward from the RUC-recommended values 
so that the size of the pool of work RVUs would be essentially 
unchanged for this family of services. Therefore, we are proposing: A 
work RVU of 2.56 for CPT code 963X0, rather than the RUC recommended 
work RVU of 2.50; a work RVU of 1.16 for CPT code 963X1, rather than 
the RUC-recommended work RVU of 1.10; a work RVU of 2.56 for CPT code 
963X3, rather than the RUC-recommended work RVU of 2.50; a work RVU of 
1.96 for CPT code 963X4, rather than the RUC-recommended work RVU of 
1.90; a work RVU of 2.56 for CPT code 963X5, rather than the RUC-
recommended work RVU of 2.50; and a work RVU of 1.96 for CPT code 
963X6, rather than the RUC-recommended work RVU of 1.90. We see no 
evidence that the typical practice for these services has changed to 
merit a reduction in valuation of professional services.
    The RUC made several revisions to the recommended direct PE inputs 
for the administration codes from their respective predecessor codes, 
including revisions to quantities of testing forms. For the supply 
item, ``psych testing forms, average'' there is a quantity of 0.10 in 
the predecessor CPT code 96101, and a quantity of 0.33 in the 
predecessor CPT code 96102. For the supply item ``neurobehavioral 
status forms, average,'' there is a quantity of 1.0 in the predecessor 
CPT code 96118 and a quantity of 0.30 for predecessor CPT code 96119, 
and for the supply item ``aphasia assessment forms, average,'' there is 
a quantity of 1.0 in the predecessor CPT code 96118 and a quantity of 
0.30 in predecessor CPT code 96119. The RUC recommendation does not 
include any forms for CPT codes 963X5 and 963X6. The RUC has replaced 
the corresponding predecessor supply items with new items ``WAIS-IV 
Record Form,'' ``WAIS-IV Response Booklet #1,'' and ``WAIS-IV Response 
Booklet #2,'' and assigned quantities of 0.165 for each of these new 
supply items for CPT codes 963X7-96X10. In our analysis, we find that 
the RUC-recommended PE refinements contributes significantly to the 
reduction in the overall payment for this code family. We see no 
compelling evidence that the quantities of testing forms used in a 
typical course of testing would have reduced dramatically and, in the 
interest of payment stability, we are proposing to refine the direct PE 
inputs for CPT codes 963X5-96X10 by including 1.0 quantity each of the 
supply items ``WAIS-IV Record Form,'' ``WAIS-IV Response Booklet #1'', 
and

[[Page 35771]]

``WAIS-IV Response Booklet #2.'' We believe that a typical course of 
testing would involve use of one booklet for each of the relevant 
codes. In addition, these proposed refinements would largely mitigate 
potentially destabilizing payment reductions for these services. We are 
seeking comment on our proposed work RVUs and proposed PE refinements 
for this family of services.
    For the direct PE inputs, we are proposing to remove the equipment 
time for the CANTAB Mobile (ED055) equipment item from CPT code 96X12. 
This item was listed at different points in the recommendations as a 
supply item with a cost of $28 per assessment and as an equipment item 
for a software license with a cost of $2,800 that could be used for up 
to 100 assessments. We are unclear as to how the CANTAB Mobile would 
typically be used in this procedure, and we are proposing to remove the 
equipment time pending the submission of more data about the item. We 
are seeking additional information about the use of this item and how 
it should best be included into the PE methodology. We are also 
interested in information as to whether the submitted invoice refers to 
the cost of the mobile device itself, or the cost of user licenses for 
the mobile device, which was unclear from the information submitted 
with the recommendations.
(57) Electrocorticography (CPT Code 96X00)
    CPT Code 95829 is used for Electrocorticogram performed at the time 
of surgery; however, a new code was needed to account for this non-
face-to-face service for the review of a month's worth or more of 
stored data. CPT code 96X00 (Electrocorticogram from an implanted brain 
neurostimulator pulse generator/transmitter, including recording, with 
interpretation and written report, up to 30 days) is a new code 
approved at the September 2017 CPT Editorial Panel Meeting to describe 
this service.
    We disagree with the RUC-recommended work RVU of 2.30 for CPT code 
96X00 and are proposing a work RVU of 1.98 based on a direct crosswalk 
to the top reference, CPT code 95957 (Digital analysis of 
electroencephalogram (EEG) (e.g., for epileptic spike analysis)). This 
is a recently-reviewed code with the same intraservice time of 30 
minutes and a total time only 2 minutes lower than CPT code 96X00. We 
agree with the survey respondents that CPT code 95957 is an accurate 
valuation for this new code, and due to the clinically similar nature 
of the two procedures and their near-identical time values, we are 
proposing to value both of them at the same work RVU of 1.98.
    The RUC did not recommend, and we did not propose, any direct PE 
inputs for CPT code 96X00.
(58) Chronic Care Remote Physiologic Monitoring (CPT Codes 990X0, 
990X1, and 994X9)
    In the CY 2018 PFS final rule, we finalized separate payment for 
CPT code 99091 (Collection and interpretation of physiologic data 
(e.g., ECG, blood pressure, glucose monitoring) digitally stored and/or 
transmitted by the patient and/or caregiver to the physician or other 
qualified health care professional, qualified by education, training, 
licensure/regulation (when applicable) requiring a minimum of 30 
minutes of time) (82 FR 53014). In that rule, we indicated that there 
would be new coding describing remote monitoring forthcoming from the 
CPT Editorial Panel and the RUC (82 FR 53014). In September 2017, the 
CPT Editorial Panel revised one code and created three new codes to 
describe remote physiologic monitoring and management and the RUC 
provided valuation recommendations through our standard rulemaking 
process.
    CPT codes 990X0 (Remote monitoring of physiologic parameter(s) 
(e.g., weight, blood pressure, pulse oximetry, respiratory flow rate), 
initial; set-up and patient education on use of equipment) and 990X1 
(Remote monitoring of physiologic parameter(s) (e.g., weight, blood 
pressure, pulse oximetry, respiratory flow rate), initial; device(s) 
supply with daily recording(s) or programmed alert(s) transmission, 
each 30 days) are both PE-only codes. We are proposing the RUC-
recommended work RVU of 0.61 for CPT code 994X9 (Remote physiologic 
monitoring treatment management services, 20 minutes or more of 
clinical staff/physician/other qualified healthcare professional time 
in a calendar month requiring interactive communication with the 
patient/caregiver during the month).
    For the direct PE inputs, we are proposing to accept the RUC-
recommended direct PE inputs for CPT code 990X0 and to remove the 
``Monthly cellular and licensing service fee'' supply from CPT code 
990X1. We do not believe that these licensing fees would be allocated 
to the use of an individual patient for an individual service, and 
instead believe they can be better understood as forms of indirect 
costs similar to office rent or administrative expenses. Therefore, we 
are proposing to remove this supply input as a form of indirect PE. We 
are proposing the direct PE inputs for CPT code 994X9 without 
refinement.
(59) Interprofessional Internet Consultation (CPT Codes 994X6, 994X0, 
99446, 99447, 99448, and 99449)
    In September 2017, the CPT Editorial Panel revised four codes and 
created two codes to describe interprofessional telephone/internet/
electronic medical record consultation services. CPT codes 99446 
(Interprofessional telephone/internet assessment and management service 
provided by a consultative physician including a verbal and written 
report to the patient's treating/requesting physician or other 
qualified health care professional; 5-10 minutes of medical 
consultative discussion and review), 99447 (Interprofessional 
telephone/internet assessment and management service provided by a 
consultative physician including a verbal and written report to the 
patient's treating/requesting physician or other qualified health care 
professional; 11-20 minutes of medical consultative discussion and 
review), 99448 (Interprofessional telephone/internet assessment and 
management service provided by a consultative physician including a 
verbal and written report to the patient's treating/requesting 
physician or other qualified health care professional; 21-30 minutes of 
medical consultative discussion and review), and 99449 
(Interprofessional telephone/internet assessment and management service 
provided by a consultative physician including a verbal and written 
report to the patient's treating/requesting physician or other 
qualified health care professional; 31 minutes or more of medical 
consultative discussion and review) describe assessment and management 
services in which a patient's treating physician or other qualified 
healthcare professional requests the opinion and/or treatment advice of 
a physician with specific specialty expertise to assist with the 
diagnosis and/or management of the patient's problem without the need 
for the face-to-face interaction between the patient and the 
consultant. These CPT codes are currently assigned a procedure status 
of B (bundled) and are not separately payable under Medicare. The CPT 
Editorial Panel revised these codes to include electronic health record 
consultations, and the RUC reaffirmed the work RVUs it had previously 
submitted for these codes. We reevaluated the submitted recommendations 
and, in light of changes in medical practice and technology, we are 
proposing to change the procedure status for CPT codes 99446, 99447, 
99448, and 99449 from B

[[Page 35772]]

(bundled) to A (active). We are also proposing the RUC re-affirmed work 
RVUs of 0.35 for CPT code 99446, 0.70 for CPT code 99447, 1.05 for CPT 
code 99448, and 1.40 for CPT code 99449.
    The CPT Editorial Panel also created two new codes, CPT code 994X0 
(Interprofessional telephone/internet/electronic health record referral 
service(s) provided by a treating/requesting physician or qualified 
health care professional, 30 minutes) and CPT code 994X6 
(Interprofessional telephone/internet/electronic health record 
assessment and management service provided by a consultative physician 
including a written report to the patient's treating/requesting 
physician or other qualified health care professional, 5 or more 
minutes of medical consultative time). The RUC-recommended work RVUs 
are 0.50 for CPT code 994X0 and 0.70 for 994X6. Since the CPT code for 
the treating/requesting physician or qualified healthcare professional 
and the CPT code for the consultative physician have similar 
intraservice times, we believe that these CPT codes should have equal 
values for work. Therefore, we are proposing a work RVU of 0.50 for 
both CPT codes 994X0 and 994X6.
    We welcome comments on this proposal. We also direct readers to 
section II.D. of this proposed rule, which includes additional detail 
regarding our proposed policies for modernizing Medicare physician 
payment by recognizing communication technology-based services.
    There are no recommended direct PE inputs for the codes in this 
family.
(60) Chronic Care Management Services (CPT Code 994X7)
    In February 2017, the CPT Editorial Panel created a new code to 
describe at least 30 minutes of chronic care management services 
performed personally by the physician or qualified health care 
professional over one calendar month. CMS began making separate payment 
for CPT code 99490 (Chronic care management services, at least 20 
minutes of clinical staff time directed by a physician or other 
qualified health care professional, per calendar month, with the 
following required elements: Multiple (two or more) chronic conditions 
expected to last at least 12 months, or until the death of the patient; 
chronic conditions place the patient at significant risk of death, 
acute exacerbation/decompensation, or functional decline; comprehensive 
care plan established, implemented, revised, or monitored) in CY 2015 
(79 FR 67715). CPT code 99490 describes 20 minutes of clinical staff 
time spent on care management services for patients with 2 or more 
chronic conditions. CPT code 99490 also includes 15 minutes of 
physician time for supervision of clinical staff. For CY 2019, the CPT 
Editorial Panel created CPT code 994X7 (Chronic care management 
services, provided personally by a physician or other qualified health 
care professional, at least 30 minutes of physician or other qualified 
health care professional time, per calendar month, with the following 
required elements: Multiple (two or more) chronic conditions expected 
to last at least 12 months, or until the death of the patient, chronic 
conditions place the patient at significant risk of death, acute 
exacerbation/decompensation, or functional decline; comprehensive care 
plan established, implemented, revised, or monitored) to describe 
situations when the billing practitioner is doing the care coordination 
work that is attributed to clinical staff in CPT code 99490. For CPT 
code 994X7, the RUC recommended a work RVU of 1.45 for 30 minutes of 
physician time. We believe this work RVU overvalues the resource costs 
associated with the physician performing the same care coordination 
activities that are performed by clinical staff in the service 
described by CPT code 99490. Additionally, this valuation of the work 
is higher than that of CPT code 99487 (Complex chronic care management 
services, with the following required elements: Multiple (two or more) 
chronic conditions expected to last at least 12 months, or until the 
death of the patient, chronic conditions place the patient at 
significant risk of death, acute exacerbation/decompensation, or 
functional decline, establishment or substantial revision of a 
comprehensive care plan, moderate or high complexity medical decision 
making; 60 minutes of clinical staff time directed by a physician or 
other qualified health care professional, per calendar month), which 
includes 60 minutes of clinical staff time, creating a rank order 
anomaly within the family of codes if we were to accept the RUC-
recommended value.
    CPT code 99490 has a work RVU of 0.61 for 15 minutes of physician 
time. Therefore, as CPT code 994X7 describes 30 minutes of physician 
time, we are proposing a work RVU of 1.22, which is double the work RVU 
of CPT code 99490.
    We are not proposing any direct PE refinements for this code 
family.
(61) Diabetes Management Training (HCPCS Codes G0108 and G0109)
    HCPCS codes G0108 (Diabetes outpatient self-management training 
services, individual, per 30 minutes) and G0109 (Diabetes outpatient 
self-management training services, group session (2 or more), per 30 
minutes) were identified on a screen of CMS or Other source codes with 
Medicare utilization greater than 100,000 services annually. For CY 
2019, we are proposing the HCPAC-recommended work RVU of 0.90 for HCPCS 
code G0108 and the HCPAC-recommended work RVU of 0.25 for HCPCS code 
G0109.
    For the direct PE inputs, we note that there is a significant 
disparity between the specialty recommendation and the final 
recommendation submitted by the HCPAC. We are concerned about the 
significant decreases in direct PE inputs in the final recommendation 
when compared to the current makeup of the two codes. The final HCPAC 
recommendation removed a series of different syringes and the patient 
education booklet that currently accompanies the procedure. We believe 
that injection training is part of these services and that the supplies 
associated with that training would typically be included in the 
procedures. Due to these concerns, we are proposing to maintain the 
current direct PE inputs for HCPCS codes G0108 and G0109. Therefore, we 
will not add the new supply item ``20x30 inch self-stick easel pad, 
white, 30 sheets/pad'' (SK129) to HCPCS code G0109, as it is not a 
current supply for HCPCS code G0109; however, we are proposing to 
accept the submitted invoice price and to add the supply to our direct 
PE database.
(62) External Counterpulsation (HCPCS Code G0166)
    HCPCS code G0166 (External counterpulsation, per treatment session) 
was identified on a screen of CMS or Other source codes with Medicare 
utilization greater than 100,000 services annually. The RUC is not 
recommending a work RVU for HCPCS code G0166 due to the belief that 
there is no physician work involved in this service. After reviewing 
this code, we are proposing a work RVU of 0.00 for HCPCS code G0166, 
and are proposing to make the code valued for PE only.
    For the direct PE inputs, we are proposing to refine the equipment 
times in accordance with our standard equipment time formulas.

[[Page 35773]]

(63) Wound Closure by Adhesive (HCPCS Code G0168)
    HCPCS code G0168 (Wound closure utilizing tissue adhesive(s) only) 
was identified as potentially misvalued on a screen of 0-day global 
services reported with an E/M visit 50 percent of the time or more, on 
the same day of service by the same patient and the same practitioner, 
that have not been reviewed in the last 5 years with Medicare 
utilization greater than 20,000. For CY 2019, the RUC recommended a 
work RVU of 0.45 based on maintaining the current work RVU.
    We disagree with the recommended value and we are proposing a work 
RVU of 0.31 for HCPCS code G0168 based on a direct crosswalk to CPT 
code 93293 (Transtelephonic rhythm strip pacemaker evaluation(s) 
single, dual, or multiple lead pacemaker system, includes recording 
with and without magnet application with analysis, review and report(s) 
by a physician or other qualified health care professional, up to 90 
days). CPT code 93293 is a recently-reviewed code with the same 5 
minutes of intraservice time and 1 fewer minute of total time. In 
reviewing HCPCS code G0168, the recommendations stated that the work 
involved in the service had not changed even though the surveyed 
intraservice time was decreasing by 50 percent, from 10 minutes to 5 
minutes. Although we do not imply that the decrease in time as 
reflected in survey values must equate to a one-to-one or linear 
decrease in the valuation of work RVUs, we believe that since the two 
components of work are time and intensity, significant decreases in 
time should be reflected in decreases to work RVUs. In the case of 
HCPCS code G0168, we believe that it would be more accurate to propose 
a work RVU of 0.31 based on the aforementioned crosswalk to CPT code 
93293 to account for these decreases in the surveyed work time. 
Maintaining the current work RVU of 0.45 despite a 50 percent decrease 
in the surveyed intraservice time would result in a significant 
increase in the intensity of HCPCS code G0168, and we have no reason to 
believe that the procedure has increased in intensity since the last 
time that it was valued.
    For the direct PE inputs, we are proposing to refine the equipment 
times in accordance with our standard equipment time formulas.
(64) Removal of Impacted Cerumen (HCPCS Code G0268)
    HCPCS code G0268 (Removal of impacted cerumen (one or both ears) by 
physician on same date of service as audiologic function testing) was 
identified as potentially misvalued on a screen of 0-day global 
services reported with an E/M visit 50 percent of the time or more, on 
the same day of service by the same patient and the same practitioner, 
that have not been reviewed in the last 5 years with Medicare 
utilization greater than 20,000. For CY 2019, we are proposing the RUC-
recommended work RVU of 0.61 for HCPCS code G0268.
    For the direct PE inputs, we are proposing to remove the clinical 
labor time for the ``Clean surgical instrument package'' (CA026) 
activity. There is no surgical instrument pack included in the 
recommended equipment for HCPCS code G0268, and this code already 
includes the standard 3 minutes allocated for cleaning the room and 
equipment. In addition, all of the instruments used in the procedure 
appear to be disposable supplies that would not require cleaning since 
they would only be used a single time.
(65) Structured Assessment, Brief Intervention, and Referral to 
Treatment for Substance Use Disorders (HCPCS Codes G0396, G0397, and 
GSBR1)
    In response to the Request for Information in the CY 2018 PFS 
proposed rule (82 FR 34172), commenters requested that CMS pay 
separately for assessment and referral related to substance use 
disorders. In the CY 2008 PFS final rule (72 FR 66371), we created two 
G-codes to allow for appropriate Medicare reporting and payment for 
alcohol and substance abuse assessment and intervention services that 
are not provided as screening services, but that are performed in the 
context of the diagnosis or treatment of illness or injury. The codes 
are HCPCS code G0396 (Alcohol and/or substance (other than tobacco) 
abuse structured assessment (e.g., AUDIT, DAST) and brief intervention, 
15 to 30 minutes)) and HCPCS code G0397 (Alcohol and/or substance 
(other than tobacco) abuse structured assessment (e.g., AUDIT, DAST) 
and intervention greater than 30 minutes)). In 2008, we instructed 
Medicare contractors to pay for these codes only when the services were 
considered reasonable and necessary.
    Given the ongoing opioid epidemic and the current needs of the 
Medicare population, we expect that these services would often be 
reasonable and necessary. However, the utilization for these services 
is relatively low, which we believe is in part due to the service-
specific documentation requirements for these codes (the current 
requirements can be found here: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/SBIRT_Factsheet_ICN904084.pdf). We believe that removing the additional 
documentation requirements will also ease the administrative burden on 
providers. Therefore, for CY 2019, we are proposing to eliminate the 
service-specific documentation requirements for HCPCS codes G0397 and 
G0398. We welcome comments on our proposal to change the documentation 
requirements for these codes.
    Additionally, we are proposing to create a third HCPCS code, GSBR1, 
with a lower time threshold in order to accurately account for the 
resource costs when practitioners furnish these services, but do not 
meet the requirements of the existing codes. The proposed code 
descriptor is: Alcohol and/or substance (other than tobacco) abuse 
structured assessment (e.g., AUDIT, DAST), and brief intervention, 5-14 
minutes. We are proposing a work RVU of 0.33, based on the intraservice 
time ratio between HCPCS codes G0396 and G0397. We welcome comments on 
this code descriptor and proposed valuation for HCPCS code GSBR1.
(66) Prolonged Services (HCPCS Code GPRO1)
    CPT codes 99354 (Prolonged evaluation and management or 
psychotherapy service(s) (beyond the typical service time of the 
primary procedure) in the office or other outpatient setting requiring 
direct patient contact beyond the usual service; first hour (List 
separately in addition to code for office or other outpatient 
Evaluation and Management or psychotherapy service)) and 99355 
(Prolonged evaluation and management or psychotherapy service(s) 
(beyond the typical service time of the primary procedure) in the 
office or other outpatient setting requiring direct patient contact 
beyond the usual service; each additional 30 minutes (List separately 
in addition to code for prolonged service)) describe additional time 
spent face-to-face with a patient. Stakeholders claim that the 
threshold of 60 minutes for CPT code 99354 is difficult to meet and is 
an impediment to billing these codes. In response to stakeholder 
feedback and as part of our proposal as discussed in section II.I. of 
this proposed rule to implement a single PFS rate for E/M visit levels 
2-5 while maintaining payment stability across the specialties, we are 
proposing HCPCS code GPRO1 (Prolonged evaluation and management or 
psychotherapy service(s) (beyond the typical service time of the 
primary procedure) in the

[[Page 35774]]

office or other outpatient setting requiring direct patient contact 
beyond the usual service; 30 minutes (List separately in addition to 
code for office or other outpatient Evaluation and Management or 
psychotherapy service)), which could be billed with any level of E/M 
code. We note that we do not propose to make any changes to CPT codes 
99354 and 99355, which could still be billed, as needed, when their 
time thresholds and all other requirements are met. We are proposing a 
work RVU of 1.17, which is equal to half of the work RVU assigned to 
CPT code 99354. Additionally, we are proposing direct PE inputs for 
HCPCS code GPRO1 that are equal to one half of the values assigned to 
CPT code 99354, which can be found in the Direct PE Inputs public use 
file for this proposed rule.
(67) Remote Pre-Recorded Services (HCPCS Code GRAS1)
    For CY 2019, we are proposing to make separate payment for remote 
services when a physician uses pre-recorded video and/or images 
submitted by a patient in order to evaluate a patient's condition 
through new HCPCS G-code GRAS1 (Remote evaluation of recorded video 
and/or images submitted by the patient (e.g., store and forward), 
including interpretation with verbal 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 are 
proposing to value this service by a direct crosswalk to CPT code 93793 
(Anticoagulant management for a patient taking warfarin, must include 
review and interpretation of a new home, office, or lab international 
normalized ratio (INR) test result, patient instructions, dosage 
adjustment (as needed), and scheduling of additional test(s), when 
performed), as we believe the work described is similar in kind and 
intensity to the work performed as part of HCPCS code GRAS1. Therefore, 
we are proposing a work RVU of 0.18, preservice time of 3 minutes, 
intraservice time of 4 minutes, and post service time of 2 minutes. We 
are also proposing to add 6 minutes of clinical labor (L037D) in the 
service period. We are seeking comment on the code descriptor and 
valuation for HCPCS code GRAS1. We direct readers to section II.D. of 
this proposed rule, which includes additional detail regarding our 
proposed policies for modernizing Medicare physician payment by 
recognizing communication technology-based services.
(68) Brief Communication Technology-Based Service, e.g., Virtual Check-
in (HCPCS Code GVCI1)
    We are proposing to create a G-code, HCPCS code GVCI1 (Brief 
communication technology based service, e.g. virtual check-in, by a 
physician or other qualified health care professional who may 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) to facilitate payment for these brief communication 
technology-based services. We propose to base the code descriptor and 
valuation for HCPCS code GVCI1 on existing CPT code 99441 (Telephone 
evaluation and management service by a physician or other qualified 
health care professional who may report evaluation and management 
services provided to an established patient, parent, or guardian 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), which is currently not separately payable under the PFS. 
As CPT code 99441 only describes telephone calls, we are proposing to 
create a new HCPCS code GVCI1 to encompass a broader array of 
communication modalities. We do, however, believe that the resource 
assumptions for CPT code 99441 would accurately account for the costs 
associated with providing the proposed virtual check-in service, 
regardless of the technology. We are proposing a work RVU of 0.25, 
based on a direct crosswalk to CPT code 99441. For the direct PE inputs 
for HCPCS code GVCI1, we are also proposing the direct PE inputs 
assigned to CPT code 99441. Given the breadth of technologies that 
could be described as telecommunications, we look forward to receiving 
public comments and working with the CPT Editorial Panel and the RUC to 
evaluate whether separate coding and payment is needed to account for 
differentiation between communication modalities. We are seeking 
comment on the code descriptor, as well as the proposed valuation for 
HCPCS code GVCI1. We direct readers to section II.D. of this proposed 
rule, which includes additional detail regarding our proposed policies 
for modernizing Medicare physician payment by recognizing communication 
technology-based services.
(69) Visit Complexity Inherent to Certain Specialist Visits (HCPCS Code 
GCG0X)
    We are proposing to create a HCPCS G-code to be reported with an E/
M service to describe the additional resource costs for specialties for 
whom E/M visit codes make up a large percentage of their total allowed 
charges and who we believe primarily bill level 4 and level 5 visits. 
The treatment approaches for these specialties generally do not have 
separate coding and are generally reported using the E/M visit codes. 
We are proposing to create HCPCS code, GCG0X (Visit complexity inherent 
to evaluation and management associated with endocrinology, 
rheumatology, hematology/oncology, urology, neurology, obstetrics/
gynecology, allergy/immunology, otolaryngology, or interventional pain 
management-centered care (Add-on code, list separately in addition to 
an evaluation and management visit)). We are proposing a valuation for 
HCPCS code GCG0X based on a crosswalk to 75 percent of the work RVU and 
time of CPT code 90785 (Interactive complexity), which would result in 
a proposed work RVU of 0.25 and a physician time of 8.25 minutes for 
HCPCS code GCG0X. CPT code 90785 has no direct PE inputs. Interactive 
complexity is an add-on code that may be billed when a psychotherapy or 
psychiatric service requires more work due to the complexity of the 
patient. We believe that this work RVU and physician time would be an 
accurate representation of the additional work associated with the 
higher level complex visits. For further discussion of proposals 
relating to this code, see section II.I of this proposed rule. We are 
seeking comment on the code descriptor, as well as the proposed 
valuation for HCPCS code GCG0X.
(70) Visit Complexity Inherent to Primary Care Services (HCPCS Code 
GPC1X)
    We are proposing to create a HCPCS G-code for primary care 
services, GPC1X (Visit complexity inherent to evaluation and management 
associated with primary medical care services that serve as the 
continuing focal point for all needed health care services (Add-on 
code, list separately in addition to an evaluation and management 
visit)). This code describes furnishing a visit to a new or existing 
patient, and can include aspects of care management, counseling, or 
treatment of acute or chronic

[[Page 35775]]

conditions not accounted for by other coding. HCPCS code GPC1X would be 
billed in addition to the E/M visit code when the visit involved 
primary care-focused services. We are proposing a work RVU of 0.07, 
physician time of 1.75 minutes. This proposed valuation accounts for 
the additional work resource costs associated with furnishing primary 
care that distinguishes E/M primary care visits from other types of E/M 
visits and maintains work budget neutrality across the office/
outpatient E/M code set. For further discussion of proposals relating 
to this code, see section II.I of this proposed rule. We are seeking 
comment on the code descriptor, as well as the proposed valuation for 
HCPCS code GPC1X.
(71) Podiatric Evaluation and Management Services (HCPCS Codes GPD0X 
and GPD1X)
    We are proposing to create two HCPCS G-codes, HCPCS codes GPD0X 
(Podiatry services, medical examination and evaluation with initiation 
of diagnostic and treatment program, new patient) and GPD1X (Podiatry 
services, medical examination and evaluation with initiation of 
diagnostic and treatment program, established patient), to describe 
podiatric evaluation and management services. We are proposing a work 
RVU of 1.36, a physician time of 28.19 minutes, and direct costs 
summing to $21.29 for HCPCS code GPD0X, and a work RVU of 0.85, 
physician time of 21.73 minutes, and direct costs summing to $15.87 for 
HCPCS code GPD1X. These values are based on the average rate for CPT 
codes 99201-99203 and CPT codes 99211-99212 respectively, weighted by 
podiatric volume. For further discussion of proposals relating to these 
codes, see section II.I of this proposed rule.
(72) Comment Solicitation on Superficial Radiation Treatment Planning 
and Management
    In the CY 2015 PFS final rule with comment period (79 FR 67666-
67667), we noted that changes to the CPT prefatory language limited the 
codes that could be reported when describing services associated with 
superficial radiation treatment (SRT) delivery, described by CPT code 
77401 (radiation treatment delivery, superficial and/or ortho voltage, 
per day). The changes effectively meant that many other related 
services were bundled with CPT code 77401, instead of being separately 
reported. For example, CPT guidance clarified that certain codes used 
to describe clinical treatment planning, treatment devices, isodose 
planning, physics consultation, and radiation treatment management 
cannot be reported when furnished in association with SRT. Stakeholders 
informed us that these changes to the CPT prefatory language prevented 
them from billing Medicare for codes that were previously frequently 
billed with CPT code 77401. We solicited comments as to whether the 
revised bundled coding for SRT allowed for accurate reporting of the 
associated services. In the CY 2016 PFS final rule with comment period 
(80 FR 70955), we noted that the RUC did not review the inputs for SRT 
procedures, and therefore, did not assess whether changes in valuation 
were appropriate in light of the bundling of associated services. In 
addition, we solicited recommendations from stakeholders regarding 
whether it would be appropriate to add physician work for this service, 
even though physician work is not included in other radiation treatment 
services. In the CY 2018 PFS proposed rule (82 FR 34012) and the CY 
2018 PFS final rule (82 FR 53082), we noted that the 2016 National 
Correct Coding Initiative (NCCI) Policy Manual for Medicare Services 
states that radiation oncology services may not be separately reported 
with E/M codes. While this NCCI edit is no longer active stakeholders 
have stated that MACs have denied claims for E/M services associated 
with SRT based on the NCCI policy manual language. According to 
stakeholders, the bundling of SRT with associated services, as well as 
coding confusion regarding the appropriate use of E/M coding to report 
associated physician work, meant that practitioners were not being paid 
appropriately for planning and treatment management associated with 
furnishing SRT. Due to these concerns regarding reporting of services 
associated with SRT, in the CY 2018 PFS proposed rule (82 FR 34012-
34013), we proposed to make separate payment for the professional 
planning and management associated with SRT using HCPCS code GRRR1 
(Superficial radiation treatment planning and management related 
services, including but not limited to, when performed, clinical 
treatment planning (for example, 77261, 77262, 77263), therapeutic 
radiology simulation-aided field setting (for example, 77280, 77285, 
77290, 77293), basic radiation dosimetry calculation (for example, 
77300), treatment devices (for example, 77332, 77333, 77334), isodose 
planning (for example, 77306, 77307, 77316, 77317, 77318), radiation 
treatment management (for example, 77427, 77431, 77432, 77435, 77469, 
77470, 77499), and associated E/M per course of treatment). We proposed 
that this code would describe the range of professional services 
associated with a course of SRT, including services similar to those 
not otherwise separately reportable under CPT guidance. Furthermore, we 
proposed that this code would have included several inputs associated 
with related professional services such as treatment planning, 
treatment devices, and treatment management. Many commenters did not 
support our proposal to make separate payment for HCPCS code GRRR1 for 
CY 2018, stating that our proposed valuation of HCPCS code GRRR1 would 
represent a significant payment reduction for the associated services 
as compared with the list of services that they could previously bill 
in association with SRT. Commenters voiced concern that the proposed 
coding would inhibit access to care and discourage the use of SRT as a 
non-surgical alternative to Mohs surgery. We received comments 
recommending a variety of potential coding solutions and found that 
there was not general agreement among commenters about a preferred 
alternative. In the CY 2018 PFS final rule (82 FR 53081-53083), we 
solicited further comment, and stated that we would continue our 
dialogue with stakeholders to address appropriate coding and payment 
for professional services associated with SRT.
    Given stakeholder feedback that we have continued to receive 
following the publication of the CY 2018 PFS final rule, we continue to 
believe that there are potential coding gaps for SRT-related 
professional services. We generally rely on the CPT process to 
determine coding specificity, and we believe that deferring to this 
process in addressing potential coding gaps is generally preferable. As 
our previous attempt at designing a coding solution in the CY 2018 PFS 
proposed rule did not gain stakeholder consensus, and given that there 
were various, in some cases diverging, suggestions on a coding solution 
from stakeholders, we are not proposing changes relating to SRT coding, 
SRT-related professional codes, or payment policies for CY 2019. 
However, we are seeking comment on the possibility of creating multiple 
G-codes specific to services associated with SRT, as was suggested by 
one stakeholder following the CY 2018 PFS final rule. These codes would 
be used separately to report services including SRT planning, initial 
patient simulation visit, treatment device design and construction 
associated with SRT, SRT management, and medical physics consultation. 
We are seeking comment

[[Page 35776]]

on whether we should create such G codes to separately report each of 
the services described above, mirroring the coding of other types of 
radiation treatment delivery. For instance, HCPCS code G6003 (Radiation 
treatment delivery, single treatment area, single port or parallel 
opposed ports, simple blocks or no blocks: Up to 5 mev) is used to 
report radiation treatment delivery, while associated professional 
services are billed with codes such as CPT codes 77427 (Radiation 
treatment management, 5 treatments), 77261 (Therapeutic radiology 
treatment planning; simple), 77332 (Treatment devices, design and 
construction; simple (simple block, simple bolus), and 77300 (Basic 
radiation dosimetry calculation, central axis depth dose calculation, 
TDF, NSD, gap calculation, off axis factor, tissue inhomogeneity 
factors, calculation of non-ionizing radiation surface and depth dose, 
as required during course of treatment, only when prescribed by the 
treating physician). We are interested in public comment on whether it 
would be appropriate to create separate codes for professional services 
associated with SRT in a coding structure parallel to radiation 
treatment delivery services such as HCPCS code G6003. We are seeking 
comment on creating these codes for inclusion in this update of the 
PFS. We are also interested in whether such codes should be contractor 
priced for CY 2019. We would consider contractor pricing such codes for 
CY 2019 because we believe that the preferable method to develop new 
coding is with multi-specialty input through the CPT and RUC process, 
and we prefer to defer nationally pricing such codes pending input from 
the CPT Editorial Panel and the RUC process to assist in determining 
the appropriate level of coding specificity for SRT-related 
professional services. Based on stakeholder feedback, we continue to 
believe there may be a coding gap for these services, and therefore, we 
are soliciting comment on whether we should create these G codes and 
allow them to be contractor priced for CY 2019. This would be an 
interim approach for addressing the potential coding gap until the CPT 
Editorial Panel and the RUC can address coding for SRT and SRT-related 
professional services, giving the CPT Editorial Panel and the RUC an 
opportunity to develop a coding solution that could be addressed in 
future rulemaking.

             Table 13--CY 2019 Proposed Work RVUs for New, Revised, and Potentially Misvalued Codes
----------------------------------------------------------------------------------------------------------------
                                                                                                   CMS time
       HCPCS             Descriptor        Current work  RVU   RUC work  RVU   CMS work  RVU      refinement
----------------------------------------------------------------------------------------------------------------
03X0T.............  Electroretinography   NEW...............               C            0.40  No.
                     (ERG) with
                     interpretation and
                     report, pattern
                     (PERG).
10021.............  Fine needle           1.27..............            1.20            1.03  No.
                     aspiration biopsy;
                     without imaging
                     guidance; first
                     lesion.
10X11.............  Fine needle           NEW...............            0.80            0.80  No.
                     aspiration biopsy;
                     without imaging
                     guidance; each
                     additional lesion.
10X12.............  Fine needle           NEW...............            1.63            1.46  No.
                     aspiration biopsy,
                     including
                     ultrasound
                     guidance; first
                     lesion.
10X13.............  Fine needle           NEW...............            1.00            1.00  No.
                     aspiration biopsy,
                     including
                     ultrasound
                     guidance; each
                     additional lesion.
10X14.............  Fine needle           NEW...............            1.81            1.81  No.
                     aspiration biopsy,
                     including
                     fluoroscopic
                     guidance; first
                     lesion.
10X15.............  Fine needle           NEW...............            1.18            1.18  No.
                     aspiration biopsy,
                     including
                     fluoroscopic
                     guidance; each
                     additional lesion.
10X16.............  Fine needle           NEW...............            2.43            2.26  No.
                     aspiration biopsy,
                     including CT
                     guidance; first
                     lesion.
10X17.............  Fine needle           NEW...............            1.65            1.65  No.
                     aspiration biopsy,
                     including CT
                     guidance; each
                     additional lesion.
10X18.............  Fine needle           NEW...............               C               C  No.
                     aspiration biopsy,
                     including MR
                     guidance; first
                     lesion.
10X19.............  Fine needle           NEW...............               C               C  No.
                     aspiration biopsy,
                     including MR
                     guidance; each
                     additional lesion.
11755.............  Biopsy of nail unit   1.31..............            1.25            1.08  No.
                     (e.g., plate, bed,
                     matrix,
                     hyponychium,
                     proximal and
                     lateral nail folds).
11X02.............  Tangential biopsy of  NEW...............            0.66            0.66  No.
                     skin, (e.g., shave,
                     scoop, saucerize,
                     curette), single
                     lesion.
11X03.............  Tangential biopsy of  NEW...............            0.38            0.29  No.
                     skin, (e.g., shave,
                     scoop, saucerize,
                     curette), each
                     separate/additional
                     lesion.
11X04.............  Punch biopsy of       NEW...............            0.83            0.83  No.
                     skin, (including
                     simple closure when
                     performed), single
                     lesion.
11X05.............  Punch biopsy of       NEW...............            0.45            0.45  No.
                     skin, (including
                     simple closure when
                     performed), each
                     separate/additional
                     lesion.
11X06.............  Incisional biopsy of  NEW...............            1.01            1.01  No.
                     skin (e.g., wedge),
                     (including simple
                     closure when
                     performed), single
                     lesion.
11X07.............  Incisional biopsy of  NEW...............            0.54            0.54  No.
                     skin (e.g., wedge),
                     (including simple
                     closure when
                     performed), each
                     separate/additional
                     lesion.
20551.............  Injection(s); single  0.75..............            0.75            0.75  No.
                     tendon origin/
                     insertion.
209X3.............  Allograft, includes   NEW...............           13.01           13.01  No.
                     templating,
                     cutting, placement
                     and internal
                     fixation when
                     performed;
                     osteoarticular,
                     including articular
                     surface and
                     contiguous bone.
209X4.............  Allograft, includes   NEW...............           11.94           11.94  No.
                     templating,
                     cutting, placement
                     and internal
                     fixation when
                     performed;
                     hemicortical
                     intercalary,
                     partial (i.e.,
                     hemicylindrical).

[[Page 35777]]

 
209X5.............  Allograft, includes   NEW...............           13.00           13.00  No.
                     templating,
                     cutting, placement
                     and internal
                     fixation when
                     performed;
                     intercalary,
                     complete (i.e.,
                     cylindrical).
27X69.............  Injection procedure   NEW...............            0.96            0.77  No.
                     for contrast knee
                     arthrography or
                     contrast enhanced
                     CT/MRI knee
                     arthrography.
29105.............  Application of long   0.87..............            0.80            0.80  No.
                     arm splint
                     (shoulder to hand).
29540.............  Strapping; ankle and/ 0.39..............            0.39            0.39  No.
                     or foot.
29550.............  Strapping; toes.....  0.25..............            0.25            0.25  No.
31623.............  Bronchoscopy, rigid   2.63..............            2.63            2.63  No.
                     or flexible,
                     including
                     fluoroscopic
                     guidance, when
                     performed; with
                     brushing or
                     protected brushings.
31624.............  Bronchoscopy, rigid   2.63..............            2.63            2.63  No.
                     or flexible,
                     including
                     fluoroscopic
                     guidance, when
                     performed; with
                     bronchial alveolar
                     lavage.
332X0.............  Transcatheter         NEW...............            6.00            6.00  No.
                     implantation of
                     wireless pulmonary
                     artery pressure
                     sensor for long
                     term hemodynamic
                     monitoring,
                     including
                     deployment and
                     calibration of the
                     sensor, right heart
                     catheterization,
                     selective pulmonary
                     catheterization,
                     radiological
                     supervision and
                     interpretation, and
                     pulmonary artery
                     angiography, when
                     performed.
332X5.............  Insertion,            NEW...............            1.53            1.53  No.
                     subcutaneous
                     cardiac rhythm
                     monitor, including
                     programming.
332X6.............  Removal,              NEW...............            1.50            1.50  No.
                     subcutaneous
                     cardiac rhythm
                     monitor.
335X1.............  Replacement, aortic   NEW...............           64.00           64.00  No.
                     valve; by
                     translocation of
                     autologous
                     pulmonary valve and
                     transventricular
                     aortic annulus
                     enlargement of the
                     left ventricular
                     outflow tract with
                     valved conduit
                     replacement of
                     pulmonary valve
                     (Ross-Konno
                     procedure).
33X01.............  Aortic hemiarch       NEW...............           19.74           19.74  No.
                     graft including
                     isolation and
                     control of the arch
                     vessels, beveled
                     open distal aortic
                     anastomosis
                     extending under one
                     or more of the arch
                     vessels, and total
                     circulatory arrest
                     or isolated
                     cerebral perfusion.
33X05.............  Transcatheter         NEW...............            8.77            7.80  No.
                     insertion or
                     replacement of
                     permanent leadless
                     pacemaker, right
                     ventricular,
                     including imaging
                     guidance (e.g.,
                     fluoroscopy, venous
                     ultrasound,
                     ventriculography,
                     femoral venography)
                     and device
                     evaluation (e.g.,
                     interrogation or
                     programming), when
                     performed.
33X06.............  Transcatheter         NEW...............            9.56            8.59  No.
                     removal of
                     permanent leadless
                     pacemaker, right
                     ventricular.
36568.............  Insertion of          1.67..............            2.11            2.11  No.
                     peripherally
                     inserted central
                     venous catheter
                     (PICC), without
                     subcutaneous port
                     or pump, without
                     imaging guidance;
                     younger than 5
                     years of age.
36569.............  Insertion of          1.70..............            1.90            1.90  No.
                     peripherally
                     inserted central
                     venous catheter
                     (PICC), without
                     subcutaneous port
                     or pump, without
                     imaging guidance;
                     age 5 years or
                     older.
36584.............  Replacement,          1.20..............            1.47            1.20  No.
                     complete, of a
                     peripherally
                     inserted central
                     venous catheter
                     (PICC), without
                     subcutaneous port
                     or pump, through
                     same venous access,
                     including all
                     imaging guidance,
                     image
                     documentation, and
                     all associated
                     radiological
                     supervision and
                     interpretation
                     required to perform
                     the replacement.
36X72.............  Insertion of          NEW...............            2.00            1.82  No.
                     peripherally
                     inserted central
                     venous catheter
                     (PICC), without
                     subcutaneous port
                     or pump, including
                     all imaging
                     guidance, image
                     documentation, and
                     all associated
                     radiological
                     supervision and
                     interpretation
                     required to perform
                     the insertion;
                     younger than 5
                     years of age.
36X73.............  Insertion of          NEW...............            1.90            1.70  No.
                     peripherally
                     inserted central
                     venous catheter
                     (PICC), without
                     subcutaneous port
                     or pump, including
                     all imaging
                     guidance, image
                     documentation, and
                     all associated
                     radiological
                     supervision and
                     interpretation
                     required to perform
                     the insertion; age
                     5 years or older.
3853X.............  Biopsy or excision    NEW...............            6.74            6.74  No.
                     of lymph node(s);
                     open,
                     inguinofemoral
                     node(s).
38792.............  Injection procedure;  0.52..............            0.65            0.65  No.
                     radioactive tracer
                     for identification
                     of sentinel node.

[[Page 35778]]

 
43X63.............  Replacement of        NEW...............            0.75            0.75  No.
                     gastrostomy tube,
                     percutaneous,
                     includes removal,
                     when performed,
                     without imaging or
                     endoscopic
                     guidance; not
                     requiring revision
                     of gastrostomy
                     tract.
43X64.............  Replacement of        NEW...............            1.41            1.41  No.
                     gastrostomy tube,
                     percutaneous,
                     includes removal,
                     when performed,
                     without imaging or
                     endoscopic
                     guidance; requiring
                     revision of
                     gastrostomy tract.
45300.............  Proctosigmoidoscopy,  0.80..............            0.80            0.80  No.
                     rigid; diagnostic,
                     with or without
                     collection of
                     specimen(s) by
                     brushing or washing
                     (separate
                     procedure).
46500.............  Injection of          1.42..............            2.00            1.74  No.
                     sclerosing
                     solution,
                     hemorrhoids.
49422.............  Removal of tunneled   6.29..............            4.00            4.00  No.
                     intraperitoneal
                     catheter.
50X39.............  Dilation of existing  NEW...............            3.37            2.78  No.
                     tract,
                     percutaneous, for
                     an endourologic
                     procedure including
                     imaging guidance
                     (e.g., ultrasound
                     and/or fluoroscopy)
                     and all associated
                     radiological
                     supervision and
                     interpretation, as
                     well as post
                     procedure tube
                     placement, when
                     performed.
50X40.............  Dilation of existing  NEW...............            5.44            4.83  Yes.
                     tract,
                     percutaneous, for
                     an endourologic
                     procedure including
                     imaging guidance
                     (e.g., ultrasound
                     and/or fluoroscopy)
                     and all associated
                     radiological
                     supervision and
                     interpretation, as
                     well as post
                     procedure tube
                     placement, when
                     performed;
                     including new
                     access into the
                     renal collecting
                     system.
52334.............  Cystourethroscopy     4.82..............            3.37            3.37  No.
                     with insertion of
                     ureteral guide wire
                     through kidney to
                     establish a
                     percutaneous
                     nephrostomy,
                     retrograde.
53850.............  Transurethral         10.08.............            5.42            5.42  No.
                     destruction of
                     prostate tissue; by
                     microwave
                     thermotherapy.
53852.............  Transurethral         10.83.............            5.93            5.93  No.
                     destruction of
                     prostate tissue; by
                     radiofrequency
                     thermotherapy.
538X3.............  Transurethral         NEW...............            5.93            5.70  No.
                     destruction of
                     prostate tissue; by
                     radiofrequency
                     generated water
                     vapor thermotherapy.
57150.............  Irrigation of vagina  0.55..............            0.50            0.50  No.
                     and/or application
                     of medicament for
                     treatment of
                     bacterial,
                     parasitic, or
                     fungoid disease.
57160.............  Fitting and           0.89..............            0.89            0.89  No.
                     insertion of
                     pessary or other
                     intravaginal
                     support device.
58100.............  Endometrial sampling  1.53..............            1.21            1.21  No.
                     (biopsy) with or
                     without
                     endocervical
                     sampling (biopsy),
                     without cervical
                     dilation, any
                     method (separate
                     procedure).
58110.............  Endometrial sampling  0.77..............            0.77            0.77  No.
                     (biopsy) performed
                     in conjunction with
                     colposcopy.
64405.............  Injection,            0.94..............            0.94            0.94  No.
                     anesthetic agent;
                     greater occipital
                     nerve.
64455.............  Injection(s),         0.75..............            0.75            0.75  No.
                     anesthetic agent
                     and/or steroid,
                     plantar common
                     digital nerve(s)
                     (e.g., Morton's
                     neuroma).
65205.............  Removal of foreign    0.71..............            0.49            0.49  No.
                     body, external eye;
                     conjunctival
                     superficial.
65210.............  Removal of foreign    0.84..............            0.75            0.61  No.
                     body, external eye;
                     conjunctival
                     embedded (includes
                     concretions),
                     subconjunctival, or
                     scleral
                     nonperforating.
67500.............  Retrobulbar           1.44..............            1.18            1.18  No.
                     injection;
                     medication
                     (separate
                     procedure, does not
                     include supply of
                     medication).
67505.............  Retrobulbar           1.27..............            1.18            0.94  No.
                     injection; &
                     alcohol.
67515.............  Injection of          1.40..............            0.84            0.75  No.
                     medication or other
                     substance into
                     Tenon's capsule.
72020.............  Radiologic            0.15..............            0.15            0.23  No.
                     examination, spine,
                     single view,
                     specify level.
72040.............  Radiologic            0.22..............            0.22            0.23  No.
                     examination, spine,
                     cervical; 2 or 3
                     views.
72050.............  Radiologic            0.31..............            0.31            0.23  No.
                     examination, spine,
                     cervical; 4 or 5
                     views.
72052.............  Radiologic            0.36..............            0.35            0.23  No.
                     examination, spine,
                     cervical; 6 or more
                     views.
72070.............  Radiologic            0.22..............            0.22            0.23  No.
                     examination, spine;
                     thoracic, 2 views.
72072.............  Radiologic            0.22..............            0.22            0.23  No.
                     examination, spine;
                     thoracic, 3 views.
72074.............  Radiologic            0.22..............            0.22            0.23  No.
                     examination, spine;
                     thoracic, minimum
                     of 4 views.
72080.............  Radiologic            0.22..............            0.22            0.23  No.
                     examination, spine;
                     thoracolumbar
                     junction, minimum
                     of 2 views.
72100.............  Radiologic            0.22..............            0.22            0.23  No.
                     examination, spine,
                     lumbosacral; 2 or 3
                     views.
72110.............  Radiologic            0.31..............            0.31            0.23  No.
                     examination, spine,
                     lumbosacral;
                     minimum of 4 views.
72114.............  Radiologic            0.32..............            0.31            0.23  No.
                     examination, spine,
                     lumbosacral;
                     complete, including
                     bending views,
                     minimum of 6 views.

[[Page 35779]]

 
72120.............  Radiologic            0.22..............            0.22            0.23  No.
                     examination, spine,
                     lumbosacral;
                     bending views only,
                     2 or 3 views.
72200.............  Radiologic            0.17..............            0.17            0.23  No.
                     examination,
                     sacroiliac joints;
                     less than 3 views.
72202.............  Radiologic            0.19..............            0.18            0.23  No.
                     examination,
                     sacroiliac joints;
                     3 or more views.
72220.............  Radiologic            0.17..............            0.17            0.23  No.
                     examination, sacrum
                     and coccyx, minimum
                     of 2 views.
73070.............  Radiologic            0.15..............            0.15            0.23  No.
                     examination, elbow;
                     2 views.
73080.............  Radiologic            0.17..............            0.17            0.23  No.
                     examination, elbow;
                     complete, minimum
                     of 3 views.
73090.............  Radiologic            0.16..............            0.16            0.23  No.
                     examination;
                     forearm, 2 views.
73650.............  Radiologic            0.16..............            0.16            0.23  No.
                     examination;
                     calcaneus, minimum
                     of 2 views.
73660.............  Radiologic            0.13..............            0.13            0.23  No.
                     examination;
                     toe(s), minimum of
                     2 views.
74210.............  Radiologic            0.36..............            0.59            0.59  No.
                     examination;
                     pharynx and/or
                     cervical esophagus.
74220.............  Radiologic            0.46..............            0.67            0.67  No.
                     examination;
                     esophagus.
74230.............  Swallowing function,  0.53..............            0.53            0.53  No.
                     with
                     cineradiography/
                     videoradiography.
74420.............  Urography,            0.36..............            0.52            0.52  No.
                     retrograde, with or
                     without KUB.
74485.............  Dilation of           0.54..............            0.83            0.83  No.
                     ureter(s) or
                     urethra,
                     radiological
                     supervision and
                     interpretation.
76000.............  Fluoroscopy           0.17..............            0.30            0.30  No.
                     (separate
                     procedure), up to 1
                     hour physician or
                     other qualified
                     health care
                     professional time,
                     other than 71023 or
                     71034 (e.g.,
                     cardiac
                     fluoroscopy).
76514.............  Ophthalmic            0.17..............            0.17            0.14  No.
                     ultrasound,
                     diagnostic; corneal
                     pachymetry,
                     unilateral or
                     bilateral
                     (determination of
                     corneal thickness).
767X1.............  Ultrasound,           NEW...............            0.59            0.59  No.
                     elastography;
                     parenchyma (e.g.,
                     organ).
767X2.............  Ultrasound,           NEW...............            0.59            0.59  No.
                     elastography; first
                     target lesion.
767X3.............  Ultrasound,           NEW...............            0.50            0.50  No.
                     elastography; each
                     additional target
                     lesion.
76870.............  Ultrasound, scrotum   0.64..............            0.64            0.64  No.
                     and contents.
76942.............  Ultrasonic guidance   0.67..............            0.67            0.67  No.
                     for needle
                     placement (e.g.,
                     biopsy, fine needle
                     aspiration biopsy,
                     injection,
                     localization
                     device), imaging
                     supervision and
                     interpretation.
76X01.............  Magnetic resonance    NEW...............            1.29            1.10  No.
                     (e.g., vibration)
                     elastography.
76X0X.............  Ultrasound, targeted  NEW...............            1.62            1.27  No.
                     dynamic microbubble
                     sonographic
                     contrast
                     characterization
                     (non-cardiac);
                     initial lesion.
76X1X.............  Ultrasound, targeted  NEW...............            0.85            0.85  No.
                     dynamic microbubble
                     sonographic
                     contrast
                     characterization
                     (non-cardiac); each
                     additional lesion
                     with separate
                     injection.
77012.............  Computed tomography   1.16..............            1.50            1.50  No.
                     guidance for needle
                     placement (e.g.,
                     biopsy, aspiration,
                     injection,
                     localization
                     device),
                     radiological
                     supervision and
                     interpretation.
77021.............  Magnetic resonance    1.50..............            1.50            1.50  No.
                     guidance for needle
                     placement (e.g.,
                     for biopsy, fine
                     needle aspiration
                     biopsy, injection,
                     or placement of
                     localization
                     device)
                     radiological
                     supervision and
                     interpretation.
77081.............  Dual-energy X-ray     0.22..............            0.20            0.20  No.
                     absorptiometry
                     (DXA), bone density
                     study, 1 or more
                     sites; appendicular
                     skeleton
                     (peripheral) (e.g.,
                     radius, wrist,
                     heel).
77X49.............  Magnetic resonance    NEW...............            1.45            1.15  No.
                     imaging, breast,
                     without contrast
                     material;
                     unilateral.
77X50.............  Magnetic resonance    NEW...............            1.60            1.30  No.
                     imaging, breast,
                     without contrast
                     material; bilateral.
77X51.............  Magnetic resonance    NEW...............            2.10            1.80  No.
                     imaging, breast,
                     without and with
                     contrast
                     material(s),
                     including computer-
                     aided detection
                     (CAD-real time
                     lesion detection,
                     characterization
                     and pharmacokinetic
                     analysis) when
                     performed;
                     unilateral.
77X52.............  Magnetic resonance    NEW...............            2.30            2.00  No.
                     imaging, breast,
                     without and with
                     contrast
                     material(s),
                     including computer-
                     aided detection
                     (CAD-real time
                     lesion detection,
                     characterization
                     and pharmacokinetic
                     analysis) when
                     performed;
                     bilateral.
85060.............  Blood smear,          0.45..............            0.45            0.36  No.
                     peripheral,
                     interpretation by
                     physician with
                     written report.
85097.............  Bone marrow, smear    0.94..............            1.00            0.94  No.
                     interpretation.
85390.............  Fibrinolysins or      0.37..............            0.75            0.75  No.
                     coagulopathy
                     screen,
                     interpretation and
                     report.
92X71.............  Electroretinography   NEW...............            0.80            0.69  No.
                     (ERG) with
                     interpretation and
                     report; full field
                     (e.g., ffERG, flash
                     ERG, Ganzfeld ERG).
92X73.............  Electroretinography   NEW...............            0.72            0.61  No.
                     (ERG) with
                     interpretation and
                     report; multifocal
                     (mfERG).

[[Page 35780]]

 
93561.............  Indicator dilution    0.25..............            0.95            0.60  No.
                     studies such as dye
                     or thermodilution,
                     including arterial
                     and/or venous
                     catheterization;
                     with cardiac output
                     measurement.
93562.............  Indicator dilution    0.01..............            0.77            0.48  No.
                     studies such as dye
                     or thermodilution,
                     including arterial
                     and/or venous
                     catheterization;
                     subsequent
                     measurement of
                     cardiac output.
93571.............  Intravascular         1.80..............            1.50            1.38  No.
                     Doppler velocity
                     and/or pressure
                     derived coronary
                     flow reserve
                     measurement
                     (coronary vessel or
                     graft) during
                     coronary
                     angiography
                     including
                     pharmacologically
                     induced stress;
                     initial vessel.
93572.............  Intravascular         1.44..............            1.00            1.00  No.
                     Doppler velocity
                     and/or pressure
                     derived coronary
                     flow reserve
                     measurement
                     (coronary vessel or
                     graft) during
                     coronary
                     angiography
                     including
                     pharmacologically
                     induced stress;
                     each additional
                     vessel.
93668.............  Peripheral arterial   0.00..............            0.00            0.00  No.
                     disease (PAD)
                     rehabilitation, per
                     session.
93XX1.............  Remote monitoring of  NEW...............            0.70            0.70  No.
                     a wireless
                     pulmonary artery
                     pressure sensor for
                     up to 30 days
                     including at least
                     weekly downloads of
                     pulmonary artery
                     pressure
                     recordings,
                     interpretation(s),
                     trend analysis, and
                     report(s) by a
                     physician or other
                     qualified health
                     care professional.
95800.............  Sleep study,          1.05..............            1.00            0.85  No.
                     unattended,
                     simultaneous
                     recording; heart
                     rate, oxygen
                     saturation,
                     respiratory
                     analysis (e.g., by
                     airflow or
                     peripheral arterial
                     tone), and sleep
                     time.
95801.............  Sleep study,          1.00..............            1.00            0.85  No.
                     unattended,
                     simultaneous
                     recording; minimum
                     of heart rate,
                     oxygen saturation,
                     and/respiratory
                     analysis (e.g., by
                     airflow or
                     peripheral arterial
                     tone).
95806.............  Sleep study,          1.25..............            1.08            0.93  No.
                     unattended,
                     simultaneous
                     recording of, heart
                     rate, oxygen
                     saturation,
                     respiratory
                     airflow, and
                     respiratory effort
                     (e.g.,
                     thoracoabdominal
                     movement).
95970.............  Electronic analysis   0.45..............            0.45            0.35  No.
                     of implanted
                     neurostimulator
                     pulse generator/
                     transmitter (e.g.,
                     contact group(s),
                     interleaving,
                     amplitude, pulse
                     width, frequency
                     (Hz), on/off
                     cycling, burst,
                     magnet mode, dose
                     lockout, patient
                     selectable
                     parameters,
                     responsive
                     neurostimulation,
                     detection
                     algorithms, closed
                     loop parameters,
                     and passive
                     parameters) by
                     physician or other
                     qualified health
                     care professional;
                     with brain, cranial
                     nerve, spinal cord,
                     peripheral nerve,
                     or sacral nerve
                     neurostimulator
                     pulse generator/
                     transmitter,
                     without programming.
95X83.............  Electronic analysis   NEW...............            0.95            0.73  No.
                     of implanted
                     neurostimulator
                     pulse generator/
                     transmitter (e.g.,
                     contact group(s),
                     interleaving,
                     amplitude, pulse
                     width, frequency
                     (Hz), on/off
                     cycling, burst,
                     magnet mode, dose
                     lockout, patient
                     selectable
                     parameters,
                     responsive
                     neurostimulation,
                     detection
                     algorithms, closed
                     loop parameters,
                     and passive
                     parameters) by
                     physician or other
                     qualified health
                     care professional;
                     with simple cranial
                     nerve
                     neurostimulator
                     pulse generator/
                     transmitter
                     programming by
                     physician or other
                     qualified health
                     care professional.
95X84.............  Electronic analysis   NEW...............            1.19            0.97  No.
                     of implanted
                     neurostimulator
                     pulse generator/
                     transmitter (e.g.,
                     contact group(s),
                     interleaving,
                     amplitude, pulse
                     width, frequency
                     (Hz), on/off
                     cycling, burst,
                     magnet mode, dose
                     lockout, patient
                     selectable
                     parameters,
                     responsive
                     neurostimulation,
                     detection
                     algorithms, closed
                     loop parameters,
                     and passive
                     parameters) by
                     physician or other
                     qualified health
                     care professional;
                     with complex
                     cranial nerve
                     neurostimulator
                     pulse generator/
                     transmitter
                     programming by
                     physician or other
                     qualified health
                     care professional.

[[Page 35781]]

 
95X85.............  Electronic analysis   NEW...............            1.25            0.91  No.
                     of implanted
                     neurostimulator
                     pulse generator/
                     transmitter (e.g.,
                     contact group(s),
                     interleaving,
                     amplitude, pulse
                     width, frequency
                     (Hz), on/off
                     cycling, burst,
                     magnet mode, dose
                     lockout, patient
                     selectable
                     parameters,
                     responsive
                     neurostimulation,
                     detection
                     algorithms, closed
                     loop parameters,
                     and passive
                     parameters) by
                     physician or other
                     qualified health
                     care professional;
                     with brain
                     neurostimulator
                     pulse generator/
                     transmitter
                     programming, first
                     15 minutes face-to-
                     face time with
                     physician or other
                     qualified health
                     care professional.
95X86.............  Electronic analysis   NEW...............            1.00            0.80  No.
                     of implanted
                     neurostimulator
                     pulse generator/
                     transmitter (e.g.,
                     contact group(s),
                     interleaving,
                     amplitude, pulse
                     width, frequency
                     (Hz), on/off
                     cycling, burst,
                     magnet mode, dose
                     lockout, patient
                     selectable
                     parameters,
                     responsive
                     neurostimulation,
                     detection
                     algorithms, closed
                     loop parameters,
                     and passive
                     parameters) by
                     physician or other
                     qualified health
                     care professional;
                     with brain
                     neurostimulator
                     pulse generator/
                     transmitter
                     programming, each
                     additional 15
                     minutes face-to-
                     face time with
                     physician or other
                     qualified health
                     care professional.
96105.............  Assessment of         1.75..............            1.75            1.75  No.
                     aphasia (includes
                     assessment of
                     expressive and
                     receptive speech
                     and language
                     function, language
                     comprehension,
                     speech production
                     ability, reading,
                     spelling, writing,
                     e.g., by boston
                     diagnostic aphasia
                     examination) with
                     interpretation and
                     report, per hour.
96110.............  Developmental         0.00..............            0.00            0.00  No.
                     screening (e.g.,
                     developmental
                     milestone survey,
                     speech and language
                     delay screen) with
                     scoring and
                     documentation, per
                     standardized
                     instrument.
96116.............  Neurobehavioral       1.86..............            1.86            1.86  No.
                     status exam
                     (clinical
                     assessment of
                     thinking, reasoning
                     and judgment, e.g.,
                     acquired knowledge,
                     attention,
                     language, memory,
                     planning and
                     problem solving,
                     and visual spatial
                     abilities), by
                     physician or other
                     qualified health
                     care professional,
                     both face-to-face
                     time with the
                     patient and time
                     interpreting test
                     results and
                     preparing the
                     report; first hour.
96125.............  Standardized          1.70..............            1.70            1.70  No.
                     cognitive
                     performance testing
                     (e.g., ross
                     information
                     processing
                     assessment) per
                     hour of a qualified
                     health care
                     professional's
                     time, both face-to-
                     face time
                     administering tests
                     to the patient and
                     time interpreting
                     these test results
                     and preparing the
                     report.
96127.............  Brief emotional/      0.00..............            0.00            0.00  No.
                     behavioral
                     assessment (e.g.,
                     depression
                     inventory,
                     attention-deficit/
                     hyperactivity
                     disorder [ADHD]
                     scale), with
                     scoring and
                     documentation, per
                     standardized
                     instrument.
963X0.............  Developmental test    NEW...............            2.50            2.56  No.
                     administration
                     (including
                     assessment of fine
                     and/or gross motor,
                     language, cognitive
                     level, social,
                     memory and/or
                     executive functions
                     by standardized
                     developmental
                     instruments when
                     performed), by
                     physician or other
                     qualified health
                     care professional,
                     with interpretation
                     and report; first
                     hour.
963X1.............  Developmental test    NEW...............            1.10            1.16  No.
                     administration
                     (including
                     assessment of fine
                     and/or gross motor,
                     language, cognitive
                     level, social,
                     memory and/or
                     executive functions
                     by standardized
                     developmental
                     instruments when
                     performed), by
                     physician or other
                     qualified health
                     care professional,
                     with interpretation
                     and report; each
                     additional 30
                     minutes.
963X2.............  Neurobehavioral       NEW...............            1.71            1.71  No.
                     status exam
                     (clinical
                     assessment of
                     thinking, reasoning
                     and judgment, e.g.,
                     acquired knowledge,
                     attention,
                     language, memory,
                     planning and
                     problem solving,
                     and visual spatial
                     abilities), by
                     physician or other
                     qualified health
                     care professional,
                     both face-to-face
                     time with the
                     patient and time
                     interpreting test
                     results and
                     preparing the
                     report; each
                     additional hour.

[[Page 35782]]

 
963X3.............  Psychological         NEW...............            2.50            2.56  No.
                     testing evaluation
                     services by
                     physician or other
                     qualified health
                     care professional,
                     including
                     integration of
                     patient data,
                     interpretation of
                     standardized test
                     results and
                     clinical data,
                     clinical decision
                     making, treatment
                     planning and
                     report, and
                     interactive
                     feedback to the
                     patient, family
                     member(s) or
                     caregiver(s), when
                     performed; first
                     hour.
963X4.............  Psychological         NEW...............            1.90            1.96  No.
                     testing evaluation
                     services by
                     physician or other
                     qualified health
                     care professional,
                     including
                     integration of
                     patient data,
                     interpretation of
                     standardized test
                     results and
                     clinical data,
                     clinical decision
                     making, treatment
                     planning and
                     report, and
                     interactive
                     feedback to the
                     patient, family
                     member(s) or
                     caregiver(s), when
                     performed; each
                     additional hour.
963X5.............  Neuropsychological    NEW...............            2.50            2.56  No.
                     testing evaluation
                     services by
                     physician or other
                     qualified health
                     care professional,
                     including
                     integration of
                     patient data,
                     interpretation of
                     standardized test
                     results and
                     clinical data,
                     clinical decision
                     making, treatment
                     planning and
                     report, and
                     interactive
                     feedback to the
                     patient, family
                     member(s) or
                     caregiver(s), when
                     performed; first
                     hour.
963X6.............  Neuropsychological    NEW...............            1.90            1.96  No.
                     testing evaluation
                     services by
                     physician or other
                     qualified health
                     care professional,
                     including
                     integration of
                     patient data,
                     interpretation of
                     standardized test
                     results and
                     clinical data,
                     clinical decision
                     making, treatment
                     planning and
                     report, and
                     interactive
                     feedback to the
                     patient, family
                     member(s) or
                     caregiver(s), when
                     performed; each
                     additional hour.
963X7.............  Psychological or      NEW...............            0.55            0.55  No.
                     neuropsychological
                     test administration
                     and scoring by
                     physician or other
                     qualified health
                     care professional,
                     two or more tests,
                     any method, first
                     30 minutes.
963X8.............  Psychological or      NEW...............            0.46            0.46  No.
                     neuropsychological
                     test administration
                     and scoring by
                     physician or other
                     qualified health
                     care professional,
                     two or more tests,
                     any method, each
                     additional 30
                     minutes.
963X9.............  Psychological or      NEW...............            0.00            0.00  No.
                     neuropsychological
                     test administration
                     and scoring by
                     technician, two or
                     more tests, any
                     method; first 30
                     minutes.
96X00.............  Electrocorticogram    NEW...............            2.30            1.98  No.
                     from an implanted
                     brain
                     neurostimulator
                     pulse generator/
                     transmitter,
                     including
                     recording, with
                     interpretation and
                     report, up to 30
                     days.
96X10.............  Psychological or      NEW...............            0.00            0.00  No.
                     neuropsychological
                     test administration
                     and scoring by
                     technician, two or
                     more tests, any
                     method; each
                     additional 30
                     minutes.
96X11.............  Psychological or      NEW...............            0.51            0.51  No.
                     neuropsychological
                     test administration
                     using single
                     instrument, with
                     interpretation and
                     report by physician
                     or other qualified
                     health care
                     professional and
                     interactive
                     feedback to the
                     patient, family
                     member(s), or
                     caregivers(s), when
                     performed.
96X12.............  Psychological or      NEW...............            0.00            0.00  No.
                     neuropsychological
                     test
                     administration,
                     with single
                     automated
                     instrument via
                     electronic
                     platform, with
                     automated result
                     only.
990X0.............  Remote monitoring of  NEW...............            0.00            0.00  No.
                     physiologic
                     parameter(s) (e.g.,
                     weight, blood
                     pressure, pulse
                     oximetry,
                     respiratory flow
                     rate), initial; set-
                     up and patient
                     education on use of
                     equipment.
990X1.............  Remote monitoring of  NEW...............            0.00            0.00  No.
                     physiologic
                     parameter(s) (e.g.,
                     weight, blood
                     pressure, pulse
                     oximetry,
                     respiratory flow
                     rate), initial;
                     device(s) supply
                     with daily
                     recording(s) or
                     programmed alert(s)
                     transmission, each
                     30 days.

[[Page 35783]]

 
99201.............  Office or other       0.48..............            0.48            0.48  No.
                     outpatient visit
                     for the evaluation
                     and management of a
                     new patient, which
                     requires these 3
                     key components: A
                     problem focused
                     history; A problem
                     focused
                     examination;
                     Straightforward
                     medical decision
                     making. Counseling
                     and/or coordination
                     of care with other
                     physicians, other
                     qualified health
                     care professionals,
                     or agencies are
                     provided consistent
                     with the nature of
                     the problem(s) and
                     the patient's and/
                     or family's needs.
                     Usually, the
                     presenting
                     problem(s) are self
                     limited or minor.
                     Typically, 10
                     minutes are spent
                     face-to-face with
                     the patient and/or
                     family.
99202.............  Office or other       0.93..............            0.93            1.90  Yes.
                     outpatient visit
                     for the evaluation
                     and management of a
                     new patient, which
                     requires these 3
                     key components: An
                     expanded problem
                     focused history; An
                     expanded problem
                     focused
                     examination;
                     Straightforward
                     medical decision
                     making. Counseling
                     and/or coordination
                     of care with other
                     physicians, other
                     qualified health
                     care professionals,
                     or agencies are
                     provided consistent
                     with the nature of
                     the problem(s) and
                     the patient's and/
                     or family's needs.
                     Usually, the
                     presenting
                     problem(s) are of
                     low to moderate
                     severity.
                     Typically, 20
                     minutes are spent
                     face-to-face with
                     the patient and/or
                     family.
99203.............  Office or other       1.42..............            1.42            1.90  Yes.
                     outpatient visit
                     for the evaluation
                     and management of a
                     new patient, which
                     requires these 3
                     key components: A
                     detailed history; A
                     detailed
                     examination;
                     Medical decision
                     making of low
                     complexity.
                     Counseling and/or
                     coordination of
                     care with other
                     physicians, other
                     qualified health
                     care professionals,
                     or agencies are
                     provided consistent
                     with the nature of
                     the problem(s) and
                     the patient's and/
                     or family's needs.
                     Usually, the
                     presenting
                     problem(s) are of
                     moderate severity.
                     Typically, 30
                     minutes are spent
                     face-to-face with
                     the patient and/or
                     family.
99204.............  Office or other       2.43..............            2.43            1.90  Yes.
                     outpatient visit
                     for the evaluation
                     and management of a
                     new patient, which
                     requires these 3
                     key components: A
                     comprehensive
                     history; A
                     comprehensive
                     examination;
                     Medical decision
                     making of moderate
                     complexity.
                     Counseling and/or
                     coordination of
                     care with other
                     physicians, other
                     qualified health
                     care professionals,
                     or agencies are
                     provided consistent
                     with the nature of
                     the problem(s) and
                     the patient's and/
                     or family's needs.
                     Usually, the
                     presenting
                     problem(s) are of
                     moderate to high
                     severity.
                     Typically, 45
                     minutes are spent
                     face-to-face with
                     the patient and/or
                     family.
99205.............  Office or other       3.17..............            3.17            1.90  Yes.
                     outpatient visit
                     for the evaluation
                     and management of a
                     new patient, which
                     requires these 3
                     key components: A
                     comprehensive
                     history; A
                     comprehensive
                     examination;
                     Medical decision
                     making of high
                     complexity.
                     Counseling and/or
                     coordination of
                     care with other
                     physicians, other
                     qualified health
                     care professionals,
                     or agencies are
                     provided consistent
                     with the nature of
                     the problem(s) and
                     the patient's and/
                     or family's needs.
                     Usually, the
                     presenting
                     problem(s) are of
                     moderate to high
                     severity.
                     Typically, 60
                     minutes are spent
                     face-to-face with
                     the patient and/or
                     family.
99211.............  Office or other       0.18..............            0.18            0.18  No.
                     outpatient visit
                     for the evaluation
                     and management of
                     an established
                     patient, that may
                     not require the
                     presence of a
                     physician or other
                     qualified health
                     care professional.
                     Usually, the
                     presenting
                     problem(s) are
                     minimal. Typically,
                     5 minutes are spent
                     performing or
                     supervising these
                     services.

[[Page 35784]]

 
99212.............  Office or other       0.48..............            0.48            1.22  Yes.
                     outpatient visit
                     for the evaluation
                     and management of
                     an established
                     patient, which
                     requires at least 2
                     of these 3 key
                     components: A
                     problem focused
                     history; A problem
                     focused
                     examination;
                     Straightforward
                     medical decision
                     making. Counseling
                     and/or coordination
                     of care with other
                     physicians, other
                     qualified health
                     care professionals,
                     or agencies are
                     provided consistent
                     with the nature of
                     the problem(s) and
                     the patient's and/
                     or family's needs.
                     Usually, the
                     presenting
                     problem(s) are self
                     limited or minor.
                     Typically, 10
                     minutes are spent
                     face-to-face with
                     the patient and/or
                     family.
99213.............  Office or other       0.97..............            0.97            1.22  Yes.
                     outpatient visit
                     for the evaluation
                     and management of
                     an established
                     patient, which
                     requires at least 2
                     of these 3 key
                     components: An
                     expanded problem
                     focused history; An
                     expanded problem
                     focused
                     examination;
                     Medical decision
                     making of low
                     complexity.
                     Counseling and
                     coordination of
                     care with other
                     physicians, other
                     qualified health
                     care professionals,
                     or agencies are
                     provided consistent
                     with the nature of
                     the problem(s) and
                     the patient's and/
                     or family's needs.
                     Usually, the
                     presenting
                     problem(s) are of
                     low to moderate
                     severity.
                     Typically, 15
                     minutes are spent
                     face-to-face with
                     the patient and/or
                     family.
99214.............  Office or other       1.50..............            1.50            1.22  Yes.
                     outpatient visit
                     for the evaluation
                     and management of
                     an established
                     patient, which
                     requires at least 2
                     of these 3 key
                     components: A
                     detailed history; A
                     detailed
                     examination;
                     Medical decision
                     making of moderate
                     complexity.
                     Counseling and/or
                     coordination of
                     care with other
                     physicians, other
                     qualified health
                     care professionals,
                     or agencies are
                     provided consistent
                     with the nature of
                     the problem(s) and
                     the patient's and/
                     or family's needs.
                     Usually, the
                     presenting
                     problem(s) are of
                     moderate to high
                     severity.
                     Typically, 25
                     minutes are spent
                     face-to-face with
                     the patient and/or
                     family.
99215.............  Office or other       2.11..............            2.11            1.22  Yes.
                     outpatient visit
                     for the evaluation
                     and management of
                     an established
                     patient, which
                     requires at least 2
                     of these 3 key
                     components: A
                     comprehensive
                     history; A
                     comprehensive
                     examination;
                     Medical decision
                     making of high
                     complexity.
                     Counseling and/or
                     coordination of
                     care with other
                     physicians, other
                     qualified health
                     care professionals,
                     or agencies are
                     provided consistent
                     with the nature of
                     the problem(s) and
                     the patient's and/
                     or family's needs.
                     Usually, the
                     presenting
                     problem(s) are of
                     moderate to high
                     severity.
                     Typically, 40
                     minutes are spent
                     face-to-face with
                     the patient and/or
                     family.
99446.............  Interprofessional     B.................            0.35            0.35  No.
                     telephone/Internet/
                     electronic health
                     record assessment
                     and management
                     service provided by
                     a consultative
                     physician including
                     a verbal and
                     written report to
                     the patient's
                     treating/requesting
                     physician or other
                     qualified
                     healthcare
                     professional; 5-10
                     minutes of medical
                     consultative
                     discussion and
                     review.
99447.............  Interprofessional     B.................            0.70            0.70  No.
                     telephone/Internet/
                     electronic health
                     record assessment
                     and management
                     service provided by
                     a consultative
                     physician including
                     a verbal and
                     written report to
                     the patient's
                     treating/requesting
                     physician or other
                     qualified
                     healthcare
                     professional; 11-20
                     minutes of medical
                     consultative
                     discussion and
                     review.
99448.............  Interprofessional     B.................            1.05            1.05  No.
                     telephone/Internet/
                     electronic health
                     record assessment
                     and management
                     service provided by
                     a consultative
                     physician including
                     a verbal and
                     written report to
                     the patient's
                     treating/requesting
                     physician or other
                     qualified
                     healthcare
                     professional; 21-30
                     minutes of medical
                     consultative
                     discussion and
                     review.

[[Page 35785]]

 
99449.............  Interprofessional     B.................            1.40            1.40  No.
                     telephone/Internet/
                     electronic health
                     record assessment
                     and management
                     service provided by
                     a consultative
                     physician including
                     a verbal and
                     written report to
                     the patient's
                     treating/requesting
                     physician or other
                     qualified
                     healthcare
                     professional; 31
                     minutes or more of
                     medical
                     consultative
                     discussion and
                     review.
994X0.............  Interprofessional     NEW...............            0.50            0.50  No.
                     telephone/Internet/
                     electronic health
                     record referral
                     service(s) provided
                     by a treating/
                     requesting
                     physician or
                     qualified health
                     care professional,
                     30 minutes.
994X6.............  Interprofessional     NEW...............            0.70            0.50  No.
                     telephone/Internet/
                     electronic health
                     record assessment
                     and management
                     service provided by
                     a consultative
                     physician including
                     a written report to
                     the patient's
                     treating/requesting
                     physician or other
                     qualified health
                     care professional,
                     5 or more minutes
                     of medical
                     consultative time.
994X7.............  CCM provided          NEW...............            1.45            1.22  No.
                     personally by a
                     physician/QHP.
994X9.............  Remote physiologic    NEW...............            0.61            0.61  No.
                     monitoring
                     treatment
                     management
                     services, 20
                     minutes or more of
                     clinical staff/
                     physician/other
                     qualified
                     healthcare
                     professional time
                     in a calendar month
                     requiring
                     interactive
                     communication with
                     the patient/
                     caregiver during
                     the month.
G0108.............  Diabetes outpatient   0.90..............            0.90            0.90  No.
                     self-management
                     training services,
                     individual, per 30
                     minutes.
G0109.............  Diabetes outpatient   0.25..............            0.25            0.25  No.
                     self-management
                     training services,
                     group session (2 or
                     more), per 30
                     minutes.
G0166.............  External              0.07..............            0.00            0.00  No.
                     counterpulsation,
                     per treatment
                     session.
G0168.............  Wound closure         0.45..............            0.45            0.31  No.
                     utilizing tissue
                     adhesive(s) only.
G0268.............  Removal of impacted   0.61..............            0.61            0.61  No.
                     cerumen (one or
                     both ears) by
                     physician on same
                     date of service as
                     audiologic function
                     testing.
GCG0X.............  Visit complexity      NEW...............  ..............            0.25  No.
                     inherent to
                     evaluation and
                     management
                     associated with
                     endocrinology,
                     rheumatology,
                     hematology/
                     oncology, urology,
                     neurology,
                     obstetrics/
                     gynecology, allergy/
                     immunology,
                     otolaryngology, or
                     interventional pain
                     management-centered
                     care (Add-on code,
                     list separately in
                     addition to an
                     evaluation and
                     management visit).
GPC1X.............  Visit complexity      NEW...............  ..............            0.07  No.
                     inherent to
                     evaluation and
                     management
                     associated with
                     primary medical
                     care services that
                     serve as the
                     continuing focal
                     point for all
                     needed health care
                     services (Add-on
                     code, list
                     separately in
                     addition to an
                     evaluation and
                     management visit).
GPD0X.............  Podiatry services,    NEW...............  ..............            1.35  No.
                     medical examination
                     and evaluation with
                     initiation of
                     diagnostic and
                     treatment program,
                     new patient.
GPD1X.............  Podiatry services,    NEW...............  ..............            0.85  No.
                     medical examination
                     and evaluation with
                     initiation of
                     diagnostic and
                     treatment program,
                     established patient.
GPRO1.............  Prolonged evaluation  NEW...............  ..............            1.17  No.
                     and management or
                     psychotherapy
                     service(s) (beyond
                     the typical service
                     time of the primary
                     procedure) in the
                     office or other
                     outpatient setting
                     requiring direct
                     patient contact
                     beyond the usual
                     service; 30 minutes
                     (List separately in
                     addition to code
                     for office or other
                     outpatient
                     Evaluation and
                     Management or
                     psychotherapy
                     service).
GRAS1.............  Remote pre-recorded   NEW...............  ..............            0.18  No.
                     service via
                     recorded video and/
                     or images submitted
                     by the patient
                     (e.g., store and
                     forward), including
                     interpretation with
                     verbal 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.
GSBR1.............  Alcohol and/or        NEW...............  ..............            0.33  No.
                     substance (other
                     than tobacco) abuse
                     structured
                     assessment (e.g.,
                     audit, dast), and
                     brief intervention,
                     5-14 minutes.

[[Page 35786]]

 
GVCI1.............  Brief communication   NEW...............  ..............            0.25  No.
                     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.
----------------------------------------------------------------------------------------------------------------

BILLING CODE 4120-01-P

[[Page 35787]]

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[[Page 35788]]


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[[Page 35789]]


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[[Page 35790]]


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[[Page 35791]]


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[[Page 35792]]


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[[Page 35793]]


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[[Page 35794]]


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[[Page 35795]]


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[[Page 35796]]


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[[Page 35797]]


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[[Page 35798]]


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[[Page 35799]]


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[[Page 35800]]


[GRAPHIC] [TIFF OMITTED] TP27JY18.013


[[Page 35801]]


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[[Page 35802]]


[GRAPHIC] [TIFF OMITTED] TP27JY18.015


[[Page 35803]]


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[[Page 35807]]


[GRAPHIC] [TIFF OMITTED] TP27JY18.020


[[Page 35808]]


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[[Page 35809]]


[GRAPHIC] [TIFF OMITTED] TP27JY18.022


[[Page 35810]]


[GRAPHIC] [TIFF OMITTED] TP27JY18.023


[[Page 35811]]


[GRAPHIC] [TIFF OMITTED] TP27JY18.024


[[Page 35812]]


[GRAPHIC] [TIFF OMITTED] TP27JY18.025


[[Page 35813]]


[GRAPHIC] [TIFF OMITTED] TP27JY18.026


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[GRAPHIC] [TIFF OMITTED] TP27JY18.027


[[Page 35815]]


[GRAPHIC] [TIFF OMITTED] TP27JY18.028


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[[Page 35817]]


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[[Page 35819]]


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[[Page 35820]]


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[[Page 35821]]


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[[Page 35828]]


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[[Page 35829]]


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[[Page 35830]]


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BILLING CODE 4120-01-C

[[Page 35831]]



                                                      Table 15--Proposed CY 2019 Existing Invoices
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                              Estimated
                                                                                                                                                 non-
                                                                                                                                               facility
                                                                                                                                               allowed
              CPT/HCPCS codes                        Item name                  CMS code          Current    Updated    Percent   Number of    services
                                                                                                   price      price      change    invoices   for  HCPCS
                                                                                                                                                codes
                                                                                                                                              using this
                                                                                                                                                 item
--------------------------------------------------------------------------------------------------------------------------------------------------------
19085, 19086, 19287, 19288................  Breast MRI computer aided   EQ370..................       0.00       0.00                     1        2,466
                                             detection and biopsy
                                             guidance software.
53850.....................................  kit, transurethral          SA036..................   1,149.00   1,000.00        -13          1        5,608
                                             microwave thermotherapy.
53852.....................................  kit, transurethral needle   SA037..................   1,050.00     900.00        -14          2        2,476
                                             ablation (TUNA).
85097.....................................  stain, Wright's Pack (per   SL140..................       0.05       0.16        235          1       43,183
                                             slide).
96116, 96118, 96119, 96125................  neurobehavioral status      SK050..................       5.77       4.00        -31          3      414,139
                                             forms, average.
258 codes.................................  scope video system          ES031..................  33,391.00  36,306.00          9               2,480,515
                                             (monitor, processor,
                                             digital capture, cart,
                                             printer, LED light).
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                         Table 16--Proposed CY 2019 New Invoices
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                             Number of      NF allowed
             CPT/HCPCS codes                         Item name                       CMS code             Average  price     invoices        services
--------------------------------------------------------------------------------------------------------------------------------------------------------
10X18, 10X19.............................  MREYE CHIBA BIOPSY NEEDLE...  SC106..........................           37.00               1               0
332X5....................................  subcutaneous cardiac rhythm   SA127..........................        5,032.50               4             280
                                            monitor system.
36X72, 36X73, 36584......................  Turbo-Ject PICC Line........  SD331..........................          170.00               1          24,402
538X3....................................  kit, Rezum delivery device..  SA128..........................        1,150.00               1             121
538X3....................................  generator, water              EQ389..........................       27,538.00              10             121
                                            thermotherapy procedure.
58100....................................  Uterine Sound...............  SD329..........................            3.17               1          59,152
58100....................................  Tenaculum...................  SD330..........................            3.77               1          59,152
767X1, 767X2, 767X3......................  sheer wave elastography       ED060..........................        9,600.00               1             493
                                            software.
76X01....................................  MR Elastography Package.....  EL050..........................      200,684.50               1             350
76X0X, 76X1X.............................  bubble contrast.............  SD332..........................          126.59               1              89
76X0X, 76X1X.............................  Ultrasound Contrast Imaging   ER108..........................        5,760.00               1              89
                                            Package.
77X51, 77X52.............................  CAD Software................  ED058..........................       17,200.00               0          36,675
77X49, 77X50, 77X51, 77X52...............  Breast coil.................  EQ388..........................       12,238.00               0          39,785
77X51, 77X52.............................  CAD Workstation (CPU + Color  ED056..........................       14,829.62               0          36,675
                                            Monitor).
85097....................................  slide stainer, automated,     EP121..........................        8,649.43               1          34,559
                                            hematology.
92X71....................................  Sleep mask..................  SK133..........................            9.95               1          10,266
92X71, 92X73.............................  mfERG and ffERG               EQ390..........................      102,400.00               1          25,602
                                            electrodiagnostic unit.
92X71, 92X73.............................  Contact lens electrode for    EQ391..........................        1,440.00               1          25,602
                                            mfERG and ffERG.
963X7, 963X8, 963X9, 96X10...............  WAIS-IV Record Form.........  SK130..........................            5.25               1         301,452
963X7, 963X8, 963X9, 96X10...............  WAIS-IV Response Booklet #1.  SK131..........................            3.30               1         301,452
963X7, 963X8, 963X9, 96X10...............  WMS-IV Response Booklet #2..  SK132..........................            2.00               1         301,452
963X7, 963X8, 963X9, 96X10...............  Wechsler Adult Intelligence   EQ387..........................          971.30               1         301,452
                                            Scale--Fourth Edition (WAIS-
                                            IV) Kit (less forms).
96X12....................................  CANTAB Mobile (per single     ED055..........................        2,800.00               1               0
                                            automated assessment).
990X1....................................  heart failure patient         EQ392..........................        1,000.00               1              58
                                            physiologic monitoring
                                            equipment package.
G0109....................................  20x30 inch self-stick easel   SK129..........................            0.00               0          93,576
                                            pad, white, 30 sheets/pad.
none.....................................  needle holder, Mayo Hegar,    SC105..........................            3.03               1               0
                                            6''.
--------------------------------------------------------------------------------------------------------------------------------------------------------


              Table 17--Proposed CY 2019 No PE Refinements
------------------------------------------------------------------------
               HCPCS                             Description
------------------------------------------------------------------------
10X11.............................  Fna bx w/o img gdn ea addl.
10X13.............................  Fna bx w/us gdn ea addl.
10X15.............................  Fna bx w/fluor gdn ea addl.
10X17.............................  Fna bx w/ct gdn ea addl.
10X18.............................  Fna bx w/mr gdn 1st les.
10X19.............................  Fna bx w/mr gdn ea addl.
332X0.............................  Tcat impl wrls p-art prs snr.
332X5.............................  Insj subq car rhythm mntr.
332X6.............................  Rmvl subq car rhythm mntr.

[[Page 35832]]

 
33X05.............................  Tcat insj/rpl perm ldls pm.
33X06.............................  Tcat rmvl perm ldls pm.
36568.............................  Insj picc <5 yr w/o imaging.
36569.............................  Insj picc 5 yr+ w/o imaging.
36584.............................  Compl rplcmt picc rs&i.
3853X.............................  Open bx/exc inguinofem nodes.
49422.............................  Remove tunneled ip cath.
50X39.............................  Dilat xst trc ndurlgc px.
50X40.............................  Dilat xst trc new access rcs.
53850.............................  Prostatic microwave thermotx.
53852.............................  Prostatic rf thermotx.
538X3.............................  Trurl dstrj prst8 tiss rf wv.
57150.............................  Treat vagina infection.
57160.............................  Insert pessary/other device.
58110.............................  Bx done w/colposcopy add-on.
65205.............................  Remove foreign body from eye.
65210.............................  Remove foreign body from eye.
67500.............................  Inject/treat eye socket.
67505.............................  Inject/treat eye socket.
67515.............................  Inject/treat eye socket.
74485.............................  Dilation urtr/urt rs&i.
76514.............................  Echo exam of eye thickness.
767X3.............................  Use ea addl target lesion.
76942.............................  Echo guide for biopsy.
77081.............................  Dxa bone density/peripheral.
93668.............................  Peripheral vascular rehab.
93XX1.............................  Rem mntr wrls p-art prs snr.
95800.............................  Slp stdy unattended.
95801.............................  Slp stdy unatnd w/anal.
95806.............................  Sleep study unatt&resp efft.
95970.............................  Alys npgt w/o prgrmg.
95X83.............................  Alys smpl cn npgt prgrmg.
95X84.............................  Alys cplx cn npgt prgrmg.
95X85.............................  Alys brn npgt prgrmg 15 min.
95X86.............................  Alys brn npgt prgrmg addl 15.
96105.............................  Assessment of aphasia.
96110.............................  Developmental screen w/score.
96116.............................  Neurobehavioral status exam.
96125.............................  Cognitive test by hc pro.
96127.............................  Brief emotional/behav assmt.
963X0.............................  Devel tst phys/qhp 1st hr.
963X1.............................  Devel tst phys/qhp ea addl.
963X2.............................  Nubhvl xm phy/qhp ea addl hr.
963X3.............................  Psycl tst eval phys/qhp 1st.
963X4.............................  Psycl tst eval phys/qhp ea.
96X00.............................  Ecog impltd brn npgt  History of Present Illness (History),
     Physical Examination (Exam) and
     Medical Decision Making (MDM).
    These codes are broadly referred to as E/M visit codes. There are 
three to five E/M visit code levels, depending on site of service and 
the extent of the three components of history, exam and MDM. For 
example, there are three to four levels of E/M visit codes in the 
inpatient hospital and nursing facility settings, based on a relatively 
narrow degree of complexity in those settings. In contrast, there are 
five levels of E/M visit codes in the office or other outpatient 
setting based on a broader range of complexity in those settings.
    Current PFS payment rates for E/M visit codes increase with the 
level of visit billed. As for all services under the PFS, the rates are 
based on the resources in terms of work (time and intensity), PE and 
malpractice expense required to furnish the typical case of the 
service. The current payment rates reflect typical service times for 
each code that are based on RUC recommendations.
    In total, E/M visits comprise approximately 40 percent of allowed 
charges for PFS services, and office/outpatient E/M visits comprise 
approximately 20 percent of allowed charges for PFS services. Within 
these percentages, there is significant variation among specialties. 
According to Medicare claims data, E/M visits are furnished by nearly 
all specialties, but represent a greater share of total allowed 
services for physicians and other practitioners who do not routinely 
furnish procedural interventions or diagnostic tests. Generally, these 
practitioners include both primary care practitioners and specialists 
such as neurologists, endocrinologists and rheumatologists. Certain 
specialties, such as podiatry, tend to furnish lower level E/M visits 
more often than higher level E/M visits. Some specialties, such as 
dermatology and otolaryngology, tend to bill more E/M visits on the 
same day as they bill minor procedures.
    Potential misvaluation of E/M codes is an issue that we have been 
carefully considering for several years. We have discussed at length in 
our recent PFS proposed and final rules that the E/M visit code set is 
outdated and needs to be revised and revalued (for example: 81 FR 46200 
and 76 FR 42793). We have noted that this code set represents a high 
proportion of PFS expenditures, but has not been recently revalued to 
account for significant changes in the disease burden of the Medicare 
patient population and changes in health care practice that are 
underway to meet the Medicare population's health care needs (81 FR 
46200). In the CY 2012 PFS proposed rule, we proposed to refer all E/M 
codes to the RUC for review as potentially misvalued (76 FR 42793). 
Many commenters to that rule were concerned about the possible 
inadequacies of the current E/M coding and documentation structure to 
address evolving chronic care management and to support primary care 
(76 FR 73060 through 73064). We did not finalize our proposal to refer 
the E/M codes for RUC review at that time. Instead, we stated that we 
would allow time for consideration of the findings of certain 
demonstrations and other initiatives to provide improved information 
for the valuation of chronic care management, primary care, and care 
transitions. We stated that we would also continue to consider the 
numerous policy alternatives that commenters offered, such as separate 
E/M codes for established visits for patients with chronic disease 
versus a post-surgical follow-up office visit.
    Many stakeholders continue to similarly express to us through 
letters, meetings, public comments in past rulemaking cycles, and other 
avenues, that the E/M code set is outdated and needs to be revised. For 
example, some stakeholders recommend an extensive research effort to 
revise and revalue E/M services, especially physician work inputs (CY 
2017 PFS final rule, 81 FR 80227-80228). In recent years, we have 
continued to consider the best ways to recognize the significant 
changes in health care practice, especially innovations in the active 
management and ongoing care of chronically ill patients, under the PFS. 
We have been engaged in an ongoing, incremental effort to identify gaps 
in appropriate coding and payment.
b. E/M Documentation Guidelines
    For coding and billing E/M visits to Medicare, practitioners may 
use one of two versions of the E/M Documentation Guidelines for a 
patient encounter, commonly referenced based on the year of their 
release: The ``1995'' or ``1997'' E/M Documentation Guidelines. These 
guidelines are available on the CMS website.\3\ They specify the 
medical record information within each of the three key components 
(such as number of body systems reviewed) that serves as support for 
billing a given level of E/M

[[Page 35833]]

visit. The 1995 and 1997 guidelines are very similar to the guidelines 
that reside within the AMA's CPT codebook for E/M visits. For example, 
the core structure of what comprises or defines the different levels of 
history, exam, and medical decision-making are the same. However, the 
1995 and 1997 guidelines include extensive examples of clinical work 
that comprise different levels of medical decision-making and do not 
appear in the AMA's CPT codebook. Also, the 1995 and 1997 guidelines do 
not contain references to preventive care that appear in the AMA's CPT 
codebook. We provide an example of how the 1995 and 1997 guidelines 
distinguish between level 2 and level 3 E/M visits in Table 18.
---------------------------------------------------------------------------

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



                 Table 18--Key Component Documentation Requirements for Level 2 vs. 3 E/M Visit
----------------------------------------------------------------------------------------------------------------
         Key component *            Level 2 (1995)      Level 3 (1995)      Level 2 (1997)      Level 3 (1997)
----------------------------------------------------------------------------------------------------------------
History (History of Present       Review of Systems   Problem Pertinent   No change from      No change from
 Illness or HPI).                  (ROS) n/a.          ROS: Inquires       1995.               1995.
                                                       about the system
                                                       directly related
                                                       to the problem(s)
                                                       identified in the
                                                       HPI.
Physical Examination (Exam).....  A limited           A limited           General multi-      General multi-
                                   examination of      examination of      system exam:        system exam:
                                   the affected body   the affected body   Performance and     Performance and
                                   area or organ       area or organ       documentation of    documentation of
                                   system.             system and other    one to five         at least six
                                                       symptomatic or      elements in one     elements in one
                                                       related organ       or more organ       or more organ
                                                       system(s).          system(s) or body   system(s) or body
                                                                           area(s).            area(s).
                                                                          Single organ        Single organ
                                                                           system exam:        system exam:
                                                                           Performance and     Performance and
                                                                           documentation of    documentation of
                                                                           one to five         at least six
                                                                           elements.           elements.
                                                                         ---------------------------------------
Medical Decision Making (MDM)     Straightforward:    Low complexity:              No change from 1995.
 Measured by: **
    1. Problem--Number of            1. Minimal.....  1. Limited.
     diagnoses/treatment options.
    2. Data--Amount and/or           2. Minimal or    2. Limited data
     complexity of data to be         no data review.  review.
     reviewed.
    3. Risk--Risk of                 3. Minimal risk  3. Low risk.
     complications and/or
     morbidity or mortality.
----------------------------------------------------------------------------------------------------------------
 * For certain settings and patient types, each of these three key components must be met or exceeded (for
  example, new patients; initial hospital visits). For others, only two of the three key components must be met
  or exceeded (for example, established patients, subsequent hospital or other visits).
** Two of three met or exceeded.

    According to both Medicare claims processing manual instructions 
and CPT coding rules, when counseling and/or coordination of care 
accounts for more than 50 percent of the face-to-face physician/patient 
encounter (or, in the case of inpatient E/M services, the floor time) 
the duration of the visit can be used as an alternative basis to select 
the appropriate E/M visit level (Pub. 100-04, Medicare Claims 
Processing Manual, Chapter 12, Section 30.6.1.C available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c12.pdf; see also 2017 CPT Codebook Evaluation and Management 
Services Guidelines, page 10). Pub. 100-04, Medicare Claims Processing 
Manual, Chapter 12, Section 30.6.1.B states, ``Instruct physicians to 
select the code for the service based upon the content of the service. 
The duration of the visit is an ancillary factor and does not control 
the level of the service to be billed unless more than 50 percent of 
the face-to-face time (for non-inpatient services) or more than 50 
percent of the floor time (for inpatient services) is spent providing 
counseling or coordination of care as described in subsection C.'' 
Subsection C states that ``the physician may document time spent with 
the patient in conjunction with the medical decision-making involved 
and a description of the coordination of care or counseling provided. 
Documentation must be in sufficient detail to support the claim.'' The 
example included in subsection C further states, ``The code selection 
is based on the total time of the face-to-face encounter or floor time, 
not just the counseling time. The medical record must be documented in 
sufficient detail to justify the selection of the specific code if time 
is the basis for selection of the code.''
    Both the 1995 and 1997 E/M guidelines contain guidelines that 
address time, which state that ``In the case where counseling and/or 
coordination of care dominates (more than 50 percent of) the physician/
patient and/or family encounter (face-to-face time in the office or 
other outpatient setting or floor/unit time in the hospital or nursing 
facility), time is considered the key or controlling factor to qualify 
for a particular level of E/M services.'' The guidelines go on to state 
that ``If the physician elects to report the level of service based on 
counseling and/or coordination of care, the total length of time of the 
encounter (face-to-face or floor time, as appropriate) should be 
documented and the record should describe the counseling and/or 
activities to coordinate care.'' \4\
---------------------------------------------------------------------------

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

    We note that other manual provisions regarding E/M visits that are 
cited in this proposed rule are housed separately within Medicare's 
Internet-Only Manuals, and are not contained within the 1995 or 1997 E/
M documentation guidelines.

[[Page 35834]]

    In accordance with section 1862(a)(1)(A) of the Act, which requires 
services paid under Medicare Part B to be reasonable and necessary for 
the diagnosis or treatment of illness or injury or to improve the 
functioning of a malformed body member, medical necessity is a 
prerequisite to Medicare payment for E/M visits. The Medicare Claims 
Processing Manual states, ``Medical necessity of a service is the 
overarching criterion for payment in addition to the individual 
requirements of a CPT code. It would not be medically necessary or 
appropriate to bill a higher level of evaluation and management service 
when a lower level of service is warranted. The volume of documentation 
should not be the primary influence upon which a specific level of 
service is billed. Documentation should support the level of service 
reported'' (Pub. 100-04, Medicare Claims Processing Manual, Chapter 12, 
Section 30.6.1A, available on the CMS website at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c12.pdf).
    Stakeholders have long maintained that all of the E/M documentation 
guidelines are administratively burdensome and outdated with respect to 
the practice of medicine. Stakeholders have provided CMS with examples 
of such outdated material (on history, exam and MDM) that can be found 
within all versions of the E/M guidelines (the AMA's CPT codebook, the 
1995 guidelines and the 1997 guidelines). Stakeholders have told CMS 
that they believe the guidelines are too complex, ambiguous, fail to 
meaningfully distinguish differences among code levels, and are not 
updated for changes in technology, especially electronic health record 
(EHR) use. Prior attempts to revise the E/M guidelines were 
unsuccessful or resulted in additional complexity due to lack of 
stakeholder consensus (with widely varying views among specialties), 
and differing perspectives on whether code revaluation would be 
necessary under the PFS as a result of revising the guidelines, which 
contributed another layer of complexity to the considerations. For 
example, an early attempt to revise the guidelines resulted in an 
additional version designed for use by certain specialties (the 1997 
version), and in CMS allowing the use of either the 1995 or 1997 
versions for purposes of documentation and billing to Medicare. Another 
complication in revising the guidelines is that they are also used by 
many other payers, which have their own payment rules and audit 
protocols. Moreover, stakeholders have suggested that there is 
sometimes variation in how Medicare's own contractors (Medicare 
Administrative Contractors (MACs) interpret and apply the guidelines as 
part of their audit processes.
    As previously mentioned, in recent years, some clinicians and other 
stakeholders have requested a major CMS research initiative to overhaul 
not only the E/M documentation guidelines, but also the underlying 
coding structure and valuation. Stakeholders have reported to CMS that 
they believe the E/M visit codes themselves need substantial updating 
and revaluation to reflect changes in the practice of medicine, and 
that revising the documentation guidelines without addressing the codes 
themselves simply preserves an antiquated framework for payment of E/M 
services.
    Last year, CMS sought public comment on potential changes to the E/
M documentation rules, deferring making any changes to E/M coding 
itself in order to immediately focus on revision of the E/M guidelines 
to reduce unnecessary administrative burden (82 FR 34078 through 
34080). In the CY 2018 PFS final rule (82 FR 53163 through 53166), we 
summarized the public comments we received and stated that we would 
take that feedback into consideration for future rulemaking. In 
response to commenters' request that we provide additional venues for 
stakeholder input, we held a listening session this year on March 18, 
2018 (transcript and materials are available on the CMS website at 
https://www.cms.gov/Outreach-and-Education/Outreach/NPC/National-Provider-Calls-and-Events-Items/2018-03-21-Documentation-Guidelines-and-Burden-Reduction.html?DLPage=1&DLEntries=10&DLSort=0&DLSortDir=descending). We 
also sought input by participating in several listening sessions 
recently hosted by the Office of the National Coordinator for Health 
Information Technology (ONC) in the course of implementing section 
4001(a) of the 21st Century Cures Act (Pub. L. 114-255). This provision 
requires the Department of Health and Human Services to establish a 
goal, develop a strategy, and make recommendations to reduce regulatory 
or administrative burdens relating to the use of EHRs. The ONC 
listening sessions sought public input on the E/M guidelines as one 
part of broader, related and unrelated burdens associated with EHRs.
    Several themes emerged from this recent stakeholder input. 
Stakeholders commended CMS for undertaking to revise the E/M guidelines 
and recommended a multi-year process. Many commenters advised CMS to 
obtain further input across specialties. They recommended town halls, 
open door forums or a task force that would come up with replacement 
guidelines that would work for all specialties over the course of 
several years. They urged CMS to proceed cautiously given the magnitude 
of the undertaking; past failed reform attempts by the AMA, CMS, and 
other payers; and the wide-ranging impact of any changes (for example, 
how other payers approach the issue).
    We received substantially different recommendations by specialty. 
Based on this feedback, it is clear that any changes would have 
substantial specialty-specific impacts, both clinical and financial. 
Based on this feedback, it also seems that the history and exam 
portions of the guidelines are most significantly outdated with respect 
to current clinical practice.
    A few stakeholders seemed to indicate that the documentation 
guidelines on history and exam should be kept in their current form. 
Many stakeholders believed they should be simplified or reduced, but 
not eliminated. Some stakeholders indicated that the documentation 
guidelines on history and exam could be eliminated altogether, and/or 
that documentation of these parts of an E/M visit could be left to 
practitioner discretion. We also heard from stakeholders that the 
degree to which an extended history and exam enables a given 
practitioner to reach a certain level of coding (and payment) varies 
according to their specialty. Many stakeholders advised CMS to increase 
reliance on medical decision-making (MDM) and time in determining the 
appropriate level of E/M visit, or to use MDM by itself, but many of 
these commenters believed that the MDM portions of the guidelines would 
need to be altered before being used alone. Commenters were divided on 
the role of time in distinguishing among E/M visit levels, and 
expressed some concern about potential abuse or inequities among more- 
or less-efficient practitioners. Some commenters expressed support for 
simplifying E/M coding generally into three levels such as low, medium 
and high, and potentially distinguishing those levels on the basis of 
time.
2. CY 2019 Proposed Policies
    Having considered the public feedback to the CY 2018 PFS proposed 
rule (82 FR 53163 through 53166) and our other outreach efforts 
described above, we are proposing several changes to E/M visit 
documentation and

[[Page 35835]]

payment. The proposed changes would only apply to office/outpatient 
visit codes (CPT codes 99201 through 99215), except where we specify 
otherwise. We agree with commenters that we should take a step-wise 
approach to these issues, and therefore, we would limit initial changes 
to the office/outpatient E/M code set. We understand from commenters 
that there are more unique issues to consider for the E/M code sets 
used in other settings such as inpatient hospital or emergency 
department care, such as unique clinical and legal issues and the 
potential intersection with hospital Conditions of Participation 
(CoPs). We may consider expanding our efforts more broadly to address 
sections of the E/M code set beyond the office/outpatient codes in 
future years.
    We wish to emphasize that, this year, we are including our proposed 
E/M documentation changes in a proposed rule due to the longstanding 
nature of our instruction that practitioners may use either the 1995 or 
1997 versions of the E/M guidelines to document E/M visits billed to 
Medicare, the magnitude of the proposed changes, and the associated 
payment policy proposals that require notice and comment rulemaking. We 
believe our proposed documentation changes for E/M visits are 
intrinsically related to our proposal to alter PFS payment for E/M 
visits (discussed below), and the PFS payment proposal for E/M visits 
requires notice and comment rulemaking. We note that we are proposing a 
relatively broad outline of changes in this proposed rule, and we 
anticipate that many details related to program integrity and ongoing 
refinement would need to be developed over time through subregulatory 
guidance. This would afford flexibility and enable us to more nimbly 
and quickly make ongoing clarifications, changes and refinements in 
response to continued practitioner experience moving forward.
a. Lifting Restrictions Related to E/M Documentation
(i) Eliminating Extra Documentation Requirements for Home Visits
    Medicare pays for E/M visits furnished in the home (a private 
residence) under CPT codes 99341 through 99350. The payment rates for 
these codes are slightly more than for office visits (for example, 
approximately $30 more for a level 5 established patient, non-
facility). The beneficiary need not be confined to the home to be 
eligible for such a visit. However, there is a Medicare Claims 
Processing Manual provision requiring that the medical record must 
document the medical necessity of the home visit made in lieu of an 
office or outpatient visit (Pub. 100-04, Medicare Claims Processing 
Manual, Chapter 12, Section 30.6.14.1.B, available on the CMS website 
at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c12.pdf). Stakeholders have suggested that whether a 
visit occurs in the home or the office is best determined by the 
practitioner and the patient without applying additional rules. We 
agree, so we are proposing to remove the requirement that the medical 
record must document the medical necessity of furnishing the visit in 
the home rather than in the office. We welcome public comments on this 
proposal, including any potential, unintended consequences of 
eliminating this requirement. If we finalize this proposal in the CY 
2019 PFS final rule, we would update the manual to reflect the change.
(ii) Public Comment Solicitation on Eliminating Prohibition on Billing 
Same-Day Visits by Practitioners of the Same Group and Specialty
    The Medicare Claims Processing Manual states, ``As for all other E/
M services except where specifically noted, the Medicare Administrative 
Contractors (MACs) may not pay two E/M office visits billed by a 
physician (or physician of the same specialty from the same group 
practice) for the same beneficiary on the same day unless the physician 
documents that the visits were for unrelated problems in the office, 
off campus-outpatient hospital, or on campus-outpatient hospital 
setting which could not be provided during the same encounter'' (Pub. 
100-04, Medicare Claims Processing Manual, Chapter 12, Section 
30.6.7.B, available on the CMS website at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c12.pdf).
    This instruction was intended to reflect the idea that multiple 
visits with the same practitioner, or by practitioners in the same or 
very similar specialties within a group practice, on the same day as 
another E/M service would not be medically necessary. However, 
stakeholders have provided a few examples where this policy does not 
make sense with respect to the current practice of medicine as the 
Medicare enrollment specialty does not always coincide with all areas 
of medical expertise possessed by a practitioner--for example, a 
practitioner with the Medicare enrollment specialty of geriatrics may 
also be an endocrinologist. If such a practitioner was one of many 
geriatricians in the same group practice, they would not be able to 
bill separately for an E/M visit focused on a patient's 
endocrinological issue if that patient had another more generalized E/M 
visit by another geriatrician on the same day. Stakeholders have 
pointed out that in these circumstances, practitioners often respond to 
this instruction by scheduling the E/M visits on two separate days, 
which could unnecessarily inconvenience the patient. Given that the 
number and granularity of practitioner specialties recognized for 
purposes of Medicare enrollment continue to increase over time 
(consistent with the medical community's requests), the value to the 
Medicare program of the prohibition on same-day E/M visits billed by 
physicians in the same group and medical specialty may be diminishing, 
especially as we believe it is becoming more common for practitioners 
to have multiple specialty affiliations, but would have only one 
primary Medicare enrollment specialty. We believe that eliminating this 
policy may better recognize the changing practice of medicine while 
reducing administrative burden. The impact of this proposal on program 
expenditures and beneficiary cost sharing is unclear. To the extent 
that many of these services are currently merely scheduled and 
furnished on different days in response to the instruction, eliminating 
this manual provision may not significantly increase utilization, 
Medicare spending and beneficiary cost sharing.
    We are soliciting public comment on whether we should eliminate the 
manual provision given the changes in the practice of medicine or 
whether there is concern that eliminating it might have unintended 
consequences for practitioners and beneficiaries. We recognize that 
this instruction may be appropriate only in certain clinical 
situations, so we seek public comments on whether and how we should 
consider creating exceptions to, or modify this manual provision rather 
than eliminating it entirely. We are also requesting that the public 
provide additional examples and situations in which the current 
instruction is not clinically appropriate.
b. Documentation Changes for Office or Other Outpatient E/M Visits and 
Home Visits
(i) Providing Choices in Documentation--Medical Decision-Making, Time 
or Current Framework
    Informed by comments and examples that we have received asserting 
that the current E/M documentation guidelines

[[Page 35836]]

are outdated with respect to the current practice of medicine, and in 
our efforts to simplify documentation for the purposes of coding E/M 
visit levels, we propose to allow practitioners to choose, as an 
alternative to the current framework specified under the 1995 or 1997 
guidelines, either MDM or time as a basis to determine the appropriate 
level of E/M visit. This would allow different practitioners in 
different specialties to choose to document the factor(s) that matter 
most given the nature of their clinical practice. It would also reduce 
the impact Medicare may have on the standardized recording of history, 
exam and MDM data in medical records, since practitioners could choose 
to no longer document many aspects of an E/M visit that they currently 
document under the 1995 or 1997 guidelines for history, physical exam 
and MDM. While we initially considered reducing the number of key 
components that practitioners needed to document in choosing the 
appropriate level of E/M service to bill, feedback from the stakeholder 
community led us to believe that offering practitioners a choice to 
either retain the current framework or choose among new options that 
involve a reduced level of documentation would be less burdensome for 
practitioners, and would allow more stability for practitioners who may 
need time to prepare for any potential new documentation framework.
    We wish to be clear that as part of this proposal, practitioners 
could use MDM, or time, or they could continue to use the current 
framework to document an E/M visit. In other words, we would be 
offering the practitioner the choice to continue to use the current 
framework by applying the 1995 or 1997 documentation guidelines for all 
three key components. However, our proposals on payment for office-
based/outpatient E/M visits described later in this section would apply 
to all practitioners, regardless of their selected documentation 
approach. All practitioners, even those choosing to retain the current 
documentation framework, would be paid at the proposed new payment rate 
described in section II.I.2.c. of this proposed rule (one rate for new 
patients and another for established patients), and could also report 
applicable G-codes proposed in that section.
    We also wish to be clear that we are proposing to retain the 
current CPT coding structure for E/M visits (along with creating new 
replacement codes for podiatry office/outpatient E/M visits) as 
described later in this section. Practitioners would report on the 
professional claim whatever level of visit (1 through 5) they believe 
they furnished using CPT codes 99201-99215. We considered making an 
alternative proposal to adopt a single G-code to describe office/
outpatient E/M visit levels 2 through 5 in conjunction with our 
proposal to establish a single PFS payment rate for those visits that 
is described later in this section. Because we believe the adoption of 
a reduced number of G-codes to describe the visit levels 2 through 5 
might result in unnecessary disruption to current billing systems and 
practices, we are not proposing to modify the existing CPT coding 
structure for E/M visits. Since we are proposing to create a single 
rate under the PFS that would be paid for services billed using the 
current CPT codes for level 2 through 5 E/M visits, it would not be 
material to Medicare's payment decision which CPT code (of levels 2 
through 5) is reported on the claim, except to justify billing a level 
2 or higher visit in comparison to a level 1 visit (provided the visit 
itself was reasonable and necessary). We expect that, for record 
keeping purposes or to meet requirements of other payers, many 
practitioners would continue to choose and report the level of E/M 
visit they believe to be appropriate under the CPT coding structure.
    Even though there would be no payment differential for E/M visits 
level 2 through 5, we believe we would still need to simplify and 
change our documentation requirements to better align with the current 
practice of medicine and eliminate unnecessary aspects of the current 
documentation framework. As a corollary to our proposal to adopt a 
single payment amount for office/outpatient E/M visit levels 2 through 
5 (see section II.I.2.c. of this proposed rule), we propose to apply a 
minimum documentation standard where, for the purposes of PFS payment 
for an office/outpatient E/M visit, practitioners would only need to 
meet documentation requirements currently associated with a level 2 
visit for history, exam and/or MDM (except when using time to document 
the service, see below). Practitioners could choose to document more 
information for clinical, legal, operational or other purposes, and we 
anticipate that for those reasons, they would continue generally to 
seek to document medical record information that is consistent with the 
level of care furnished. For purposes of our medical review, however, 
for practitioners using the current documentation framework or, as we 
are proposing, MDM, Medicare would only require documentation to 
support the medical necessity of the visit and the documentation that 
is associated with the current level 2 CPT visit code.
    For example, for a practitioner choosing to document using the 
current framework (1995 or 1997 guidelines), our proposed minimum 
documentation for any billed level of E/M visit from levels 2 through 5 
could include: (1) A problem-focused history that does not include a 
review of systems or a past, family, or social history; (2) a limited 
examination of the affected body area or organ system; and (3) 
straightforward medical decision making measured by minimal problems, 
data review, and risk (two of these three). If the practitioner was 
choosing to document based on MDM alone, Medicare would only require 
documentation supporting straightforward medical decision-making 
measured by minimal problems, data review, and risk (two of these 
three).
    Some commenters have suggested that the current framework of 
guidelines for the MDM component of visits would need to be changed 
before MDM could be relied upon by itself to distinguish visit levels. 
We propose to allow practitioners to rely on MDM in its current form to 
document their visit, and are soliciting public comment on whether and 
how guidelines for MDM might be changed in subsequent years.
    As described earlier, we currently allow time or duration of visit 
to be used as the governing factor in selecting the appropriate E/M 
visit level, only when counseling and/or coordination of care accounts 
for more than 50 percent of the face-to-face physician/patient 
encounter (or, in the case of inpatient E/M services, the floor time). 
Our proposal to allow practitioners the choice of using time to 
document office/outpatient E/M visits would mean that this time-based 
standard is not limited to E/M visits in which counseling and/or care 
coordination accounts for more than 50 percent of the face-to-face 
practitioner/patient encounter. Rather, the amount of time personally 
spent by the billing practitioner face-to-face with the patient could 
be used to document the E/M visit regardless of the amount of 
counseling and/or care coordination furnished as part of the face-to-
face encounter.
    Some commenters have raised concerns with reliance on time to 
distinguish visit levels, for example the potential for abuse, 
inequities among more- or less-efficient practitioners, and specialties 
for which time is less of a factor in determining visit complexity. 
Relying on time as the basis for

[[Page 35837]]

identifying the E/M visit level also raises the issue of what would be 
required by way of supporting documentation; for example, what amount 
of time should be documented, and whether the specific activities 
comprising the time need to be documented and to what degree. However, 
a number of stakeholders have suggested that, within their specialties, 
time is a good indicator of the complexity of the visit or patient, and 
requested that we allow practitioners to use time as the single factor 
in all E/M visits, not just when counseling or care coordination 
dominate a visit. We agree that for some practitioners and patients, 
time may be a good indicator of complexity of the visit, and are 
proposing to allow practitioners the option to use time as the single 
factor in selecting visit level and documenting the E/M visit, 
regardless of whether counseling or care coordination dominate the 
visit. If finalized, we would monitor the results of this proposed 
policy for any program integrity issues, administrative burden or other 
issues.
    For practitioners choosing to support their coding and payment for 
an E/M visit by documenting the amount of time spent with the patient, 
we propose to require the practitioner to document the medical 
necessity of the visit and show the total amount of time spent by the 
billing practitioner face-to-face with the patient. We are soliciting 
public comment on what that total time should be for payment of the 
single, new rate for E/M visits levels 2 through 5. The typical time 
for our proposed new payment for E/M visit levels 2 through 5 is 31 
minutes for an established patient and 38 minutes for a new patient, 
and we could use these times. These times are weighted averages of the 
intra-service times across the current E/M visit utilization. 
Accordingly, these times are higher than the current typical time for a 
level 2, 3 or 4 visit, but lower than the current typical time for a 
level 5 visit. We note that currently the PFS does not require the 
practitioner to spend or document a specified amount of time with a 
given patient in order to receive payment for an E/M visit, unless the 
visit is dominated by counseling/care coordination and, on that 
account, the practitioner is using time as the basis for code 
selection. The times for E/M visits and most other PFS services in the 
physician time files, which are used to set PFS rates, are typical 
times rather than requirements, and were recommended by the AMA RUC and 
then reviewed and either adopted or adjusted for Medicare through our 
usual rate setting process as ``typical,'' but not strictly required.
    One alternative is to apply the AMA's CPT codebook provision that, 
for timed services, a unit of time is attained when the mid-point is 
passed,\5\ such that we would require documentation that at least 16 
minutes for an established patient (more than half of 31 minutes) and 
at least 20 minutes for a new patient (more than half of 38 minutes) 
were spent face-to-face by the billing practitioner with the patient, 
to support making payment at the proposed single rate for visit levels 
2 through 5 when the practitioner chooses to document the visit using 
time.
---------------------------------------------------------------------------

    \5\ 2017 CPT Codebook Introduction, p.xv.
---------------------------------------------------------------------------

    Another alternative is to require documentation that the typical 
time for the CPT code that is reported (which is also the typical time 
listed in the AMA's CPT codebook for that code) was spent face-to-face 
by the billing practitioner with the patient. For example, a 
practitioner reporting CPT code 99212 (a level 2 established patient 
visit) would be required to document having spent a minimum of 10 
minutes, and a practitioner reporting CPT code 99214 (a level 4 
established patient visit) would be required to document having spent a 
minimum of 25 minutes. Under this approach, the total amount of time 
spent by the billing practitioner face-to-face with the patient would 
inform the level of E/M visit (of levels 2 through 5) coded by the 
billing practitioner. We note that in contrast to other proposed 
documentation approaches discussed above, this approach of requiring 
documentation of the typical time associated with the CPT visit code 
reported on the claim would introduce unique payment implications for 
reporting that code, especially when the time associated with the 
billed E/M code is the basis for reporting prolonged E/M services.
    We are soliciting public comments on the use of time as a framework 
for documentation of office/outpatient E/M visits, and whether we 
should adopt any of these approaches or specify other requirements with 
respect to the proposed option for documentation using time.
    In providing us with feedback, we ask commenters to take into 
consideration ways in which the time associated with, or required for, 
the billing of any add-on codes (especially the proposed prolonged E/M 
visit add-on code(s) described in section II.I.2.d.v. of this proposed 
rule) would intersect with the time spent for the base E/M visit, when 
the practitioner is documenting the E/M visit using only time. 
Currently, when reporting prolonged E/M services, we expect the 
practitioner to exceed the typical time assigned for the base E/M visit 
code (also commonly referred to as the companion code). For example, in 
the CY 2017 PFS final rule (81 FR 80229), we expressed appreciation for 
the commenters' suggestion to display the typical times associated with 
relevant services. We also discussed, and in response to those 
comments, decided to post a file annually that notes the times assumed 
to be typical for purposes of PFS ratesetting for practitioners to use 
as a reference in deciding whether time requirements for reporting 
prolonged E/M services are met. We stated that while these typical 
times are not required for a practitioner to bill the displayed base 
codes, we would expect that only time spent in excess of these times 
would be reported using a non-face-to-face prolonged service code. We 
are now proposing to formalize this policy in the case where a 
practitioner uses time to document a visit, since there would be a 
stricter time requirement associated with the base E/M code. 
Specifically, we propose that, when a practitioner chooses to document 
using time and also reports prolonged E/M services, we would require 
the practitioner to document that the typical time required for the 
base or ``companion'' visit is exceeded by the amount required to 
report prolonged services. See section II.I.2.d.v. of this proposed 
rule for further discussion of our proposal regarding reporting 
prolonged E/M services.
    As we discuss further in this section of the proposed rule, we 
believe that allowing practitioners to choose the most appropriate 
basis for distinguishing among the levels of E/M visits and applying a 
minimum documentation requirement, together with reducing the payment 
variation among E/M visit levels, would significantly reduce 
administrative burden for practitioners, and would avoid the current 
need to make coding and documentation decisions based on codes and 
documentation guidelines that are not a good fit with current medical 
practice. The practitioner could choose to use MDM, time or the current 
documentation framework, and could also apply the proposed policies 
below regarding redundancy and who can document information in the 
medical record.
    We heard from a few commenters on the CY 2018 PFS proposed rule 
that some practitioners rely on unofficial Marshfield clinic or other 
criteria to help them document E/M visit levels. These commenters 
conveyed that the

[[Page 35838]]

Marshfield ``point system'' is commonly used to supplement the E/M 
documentation guidelines, because of a lack of concrete criteria for 
certain elements of medical decision making in the 1995 and 1997 
guidelines or in CPT guidance. We are soliciting public comment on 
whether Medicare should use or adopt any aspects of other E/M 
documentation systems that may be in use among practitioners, such as 
the Marshfield tool. We are interested in feedback as to whether the 
1995 and 1997 guidelines contain adequate information for practitioners 
to use in documenting visits under our proposals, or whether these 
versions of the guidelines would need to be supplemented in any way.
    We are seeking public comment on these proposals to provide 
practitioners choice in the basis for documenting E/M visits in an 
effort to allow for documentation alternatives that better reflect the 
current practice of medicine and to alleviate documentation burden. We 
are also interested in public comments on practitioners' ability to 
avail themselves of these choices with respect to how they would impact 
clinical workflows, EHR templates, and other aspects of practitioner 
work. Commenters have requested that CMS not merely shift burden by 
implementing another framework that might avoid issues caused by the 
current guidelines, but that would be equally complex and burdensome. 
Our primary goal is to reduce administrative burden so that the 
practitioner can focus on the patient, and we are interested in 
commenters' opinions as to whether our E/M visit proposals would, in 
fact, support and further this goal. We believe these proposals would 
allow practitioners to exercise greater clinical judgment and 
discretion in what they document, focusing on what is clinically 
relevant and medically necessary for the patient. While we propose to 
no longer apply much of the E/M documentation guidelines involving 
history, exam and, for those choosing to document based on time, 
documentation of medical decision-making, our expectation is that 
practitioners would continue to perform and document E/M visits as 
medically necessary for the patient to ensure quality and continuity of 
care. For example, we believe that it remains an important part of care 
for the practitioner to understand the patient's social history, even 
though we would no longer require that history to be documented to bill 
Medicare for the visit.
(ii) Removing Redundancy in E/M Visit Documentation
    Stakeholders have recently expressed that CMS should not require 
documentation of information in the billing practitioner's note that is 
already present in the medical record, particularly with regard to 
history and exam. Currently, both the 1995 and 1997 guidelines provide 
such flexibility for certain parts of the history for established 
patients, stating, ``A Review of Systems ``ROS'' and/or a pertinent 
past, family, and/or social history ``PFSH'' obtained during an earlier 
encounter does not need to be re-recorded if there is evidence that the 
physician reviewed and updated the previous information. This may occur 
when a physician updates his/her own record or in an institutional 
setting or group practice where many physicians use a common record. 
The review and update may be documented by:
     Describing any new ROS and/or PFSH information or noting 
there has been no change in the information; and
     Noting the date and location of the earlier ROS and/or 
PFSH.
    Documentation Guidelines ``DG'': The ROS and/or PFSH may be 
recorded by ancillary staff or on a form completed by the patient. To 
document that the physician reviewed the information, there must be a 
notation supplementing or confirming the information recorded by others 
(https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNEdWebGuide/Downloads/95Docguidelines.pdf; https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNEdWebGuide/Downloads/97Docguidelines.pdf).
    We propose to expand this policy to further simplify the 
documentation of history and exam for established patients such that, 
for both of these key components, practitioners would only be required 
to focus their documentation on what has changed since the last visit 
or on pertinent items that have not changed, rather than re-documenting 
a defined list of required elements such as review of a specified 
number of systems and family/social history. Since medical decision-
making can only be accurately formed upon a substantial basis of 
accurate and timely health information, and the CPT code descriptors 
for all E/M visits would continue to include the elements of history 
and exam, we expect that practitioners would still conduct clinically 
relevant and medically necessary elements of history and physical exam, 
and conform to the general principles of medical record documentation 
in the 1995 and 1997 guidelines. However, practitioners would not need 
to re-record these elements (or parts thereof) if there is evidence 
that the practitioner reviewed and updated the previous information.
    We are seeking comment on whether there may be ways to implement a 
similar provision for any aspects of medical decision-making, or for 
new patients, such as when prior data is available to the billing 
practitioner through an interoperable EHR or other data exchange. We 
believe there would be special challenges in realizing documentation 
efficiencies with new patients, since they may not have received exams 
or histories that were complete or relevant to the current 
complaint(s), and the information in the transferred record could be 
more likely to be incomplete, outdated or inaccurate.
    Also, we propose that for both new and established patients, 
practitioners would no longer be required to re-enter information in 
the medical record regarding the chief complaint and history that are 
already entered by ancillary staff or the beneficiary. The practitioner 
could simply indicate in the medical record that they reviewed and 
verified this information. We wish to be clear that these proposed 
policy changes would be optional, where a practitioner could choose to 
continue to use the current framework, and the more detailed 
information could continue to be entered, re-entered or brought forward 
in documenting a visit, regardless of the documentation approach 
selected by the practitioner. Our goal is to allow practitioners more 
flexibility to exercise greater clinical judgment and discretion in 
what they document, focusing on what is clinically relevant and 
medically necessary for the patient. Our expectation is that 
practitioners would continue to periodically review and assess static 
or baseline historical information at clinically appropriate intervals.
(iii) Podiatry Visits
    As described in greater detail in section II.I.2.d.iii. of this 
proposed rule, as part of our proposal to improve payment accuracy by 
creating a single PFS payment rate for E/M visit levels 2 through 5 
(with one proposed rate for new patients and one proposed rate for 
established patients), we propose to create separate coding for 
podiatry visits that are currently reported as E/M office/outpatient 
visits. We propose that, rather than reporting visits under the general 
E/M office/outpatient visit

[[Page 35839]]

code set, podiatrists would instead report visits under new G-codes 
that more specifically identify and value their services. We propose to 
apply substantially the same documentation standards for these proposed 
new podiatry-specific codes as we propose above for other office/
outpatient E/M visits.
    If a practitioner chose to use time to document a podiatry office/
outpatient E/M visit, we propose to apply substantially the same rules 
as those we are proposing for documenting on the basis of time for 
other office/outpatient E/M visits, discussed above. For practitioners 
choosing to use time to provide supporting documentation for the 
podiatry visit, we would require documentation supporting the medical 
necessity of the visit and showing the total amount of time spent by 
the billing practitioner face-to-face with the patient. We are 
soliciting public comment on what that total time would be for payment 
of the proposed new podiatry G-codes. The typical times for these 
proposed codes are 22 minutes for an established patient and 28 minutes 
for a new patient, and we could use these times. Alternatively, we 
could apply the AMA's CPT codebook provision that, for timed services, 
a unit of time is attained when the mid-point is passed,\6\ such that 
we would require documentation that at least 12 minutes for an 
established patient (more than half of 22 minutes) or at least 15 
minutes for a new patient (more than half of 28 minutes) were spent 
face-to-face by the billing practitioner with the patient, to support 
making payment for these codes when the practitioner chooses to 
document the visit using time. We are soliciting comment on the use of 
time as a basis for documentation of our proposed podiatric E/M visit 
codes, and whether we should adopt any of these approaches or further 
specify other requirements with respect to this proposed option for 
podiatric practitioners to document their visits using time.
---------------------------------------------------------------------------

    \6\ 2017 CPT Codebook Introduction, p.xv.
---------------------------------------------------------------------------

c. Minimizing Documentation Requirements by Simplifying Payment Amounts
    As we have explained above, including in prior rulemaking, we 
believe that the coding, payment, and documentation requirements for E/
M visits are overly burdensome and no longer aligned with the current 
practice of medicine. We believe the current set of 10 CPT codes for 
new and established office-based and outpatient E/M visits and their 
respective payment rates no longer appropriately reflect the complete 
range of services and resource costs associated with furnishing E/M 
services to all patients across the different physician specialties, 
and that documenting these services using the current guidelines has 
become burdensome and out of step with the current practice of 
medicine. We have included the proposals described above to mitigate 
the burden associated with the outdated documentation guidelines for 
these services. To alleviate the effects and mitigate the burden 
associated with continued use of the outdated CPT code set, we are 
proposing to simplify the office-based and outpatient E/M payment rates 
and documentation requirements, and create new add-on codes to better 
capture the differential resources involved in furnishing certain types 
of E/M visits.
    In conjunction with our proposal to reduce the documentation 
requirements for E/M visit levels 2 through 5, we are proposing to 
simplify the payment for those services by paying a single rate for the 
level 2 through 5 E/M visits. The visit level of the E/M service is 
tied to the documentation requirements in the 1995 and 1997 
Documentation Guidelines for E/M Services, which may not be reflective 
of changes in technology or, in particular, the ways that electronic 
medical records have changed documentation and the patient's medical 
record. Additionally, current documentation requirements may not 
account for changes in care delivery, such as a growing emphasis on 
team based care, increases in the number of recognized chronic 
conditions, or increased emphasis on access to behavioral health care. 
However, based on the feedback we have received from stakeholders, it 
is clear to us that the burdens associated with documenting the 
selection of the level of E/M service arise from not only the 
documentation guidelines, but also from the coding structure itself. 
Like the documentation guidelines, the distinctions between visit 
levels reflect a reasonable assessment of variations in care, effort, 
and resource costs as identified and articulated several decades ago. 
We believe that the most important distinctions between the kinds of 
visits furnished to Medicare beneficiaries are not well reflected by 
the current E/M visit coding. Most significantly, we have understood 
from stakeholders that current E/M coding does not reflect important 
distinctions in services and differences in resources. At present, we 
believe the current payment for E/M visit levels, generally 
distinguished by common elements of patient history, physical exam, and 
MDM, that may have been good approximations for important distinctions 
in resource costs between kinds of visits in the 1990s, when the CPT 
developed the E/M code set, are increasingly outdated in the context of 
changing models of care and information technologies.
    As described earlier in this section, we are proposing to change 
the documentation requirements for E/M levels such that practitioners 
have the choice to use the 1995 guidelines, 1997 guidelines, time, or 
MDM to determine the E/M level. We believe that these proposed changes 
will better reflect the current practice of medicine and represent 
significant reductions in burdens associated with documenting visits 
using the current set of E/M codes.
    In alignment with our proposed documentation changes, we are 
proposing to develop a single set of RVUs under the PFS for E/M office-
based and outpatient visit levels 2 through 5 for new patients (CPT 
codes 99202 through 99205) and a single set of RVUs for visit levels 2 
through 5 for established patients (CPT codes 99212 through 99215). 
While we considered creating new HCPCS G-codes that would describe the 
services associated with these proposed payment rates, given the wide 
and longstanding use of these visit codes by both Medicare and private 
payers, we believe it would have created unnecessary administrative 
burden to propose new coding. Therefore, we are instead proposing to 
maintain the current code set. Of the five levels of office-based and 
outpatient E/M visits, the vast majority of visits are reported as 
levels 3 and 4. In CY 2016, CPT codes 99203 and 99204 (or E/M visit 
level 3 and level 4 for new patients) made up around 32 percent and 44 
percent, respectively, of the total allowed charges for CPT codes 
99201-99205. In the same year, CPT codes 99213 and 99214 (or E/M visit 
level 3 and 4 for established patients) made up around 39 percent and 
50 percent, respectively, of the allowed charges for CPT codes 99211-
99215. If our proposals to simplify the documentation requirements and 
to pay a single PFS rate for new patient E/M visit levels 2 through 5 
and a single rate for established patient E/M visit levels 2 through 5 
are finalized, practitioners would still bill the CPT code for 
whichever level of E/M service they furnished and they would be paid at 
the single PFS rate. However, we believe that eliminating the 
distinction in payment between visit levels 2 through 5 will eliminate 
the need to audit against the visit levels, and therefore,

[[Page 35840]]

will provide immediate relief from the burden of documentation. A 
single payment rate will also eliminate the increasingly outdated 
distinction between the kinds of visits that are reflected in the 
current CPT code levels in both the coding and the associated 
documentation rules.
    In order to set RVUs for the proposed single payment rate for new 
and established patient office/outpatient E/M visit codes, we are 
proposing to develop resource inputs based on the current inputs for 
the individual E/M codes, generally weighted by the frequency at which 
they are currently billed, based on the 5 most recent years of Medicare 
claims data (CY 2012 through CY 2017). Specifically, we are proposing a 
work RVU of 1.90 for CPT codes 99202-99205, a physician time of 37.79 
minutes, and direct PE inputs that sum to $24.98, each based on an 
average of the current inputs for the individual codes weighted by 5 
years of accumulated utilization data. Similarly, we are proposing a 
work RVU of 1.22 for CPT codes 99212-99215, with a physician time of 
31.31 minutes and direct PE inputs that sum to $20.70. These inputs are 
based on an average of the inputs for the individual codes, weighted by 
volume based on utilization data from the past 5 years (CY 2012 through 
CY 2017). Tables 19 and 20 reflect the payment rates in dollars that 
would result from the approach described above were it to have been 
implemented for CY 2018. In other words, the dollar amounts in the 
charts below reflect how the changes we are proposing for CY 2019 would 
have impacted payment rates for CY 2018. Proposed RVUs for CY 2019 
appear in addendum B of this proposed rule, available on the CMS 
website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/.

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


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

    While we believe that the proposed rates for E/M visit levels 2 
through 5 represent the valuation of a typical E/M service, we also 
recognize that the current E/M code set itself does not appropriately 
reflect differences in resource costs between certain types of E/M 
visits. As a result, we believe that the way we currently value the 
resource costs for E/M services through the existing HCPCS CPT code set 
for office-based and outpatient E/M visits does not appropriately 
reflect the resources used in furnishing the range of E/M services that 
are provided through the current the practice of medicine. Based on 
stakeholder comments and examples and our review of the literature on 
E/M services, we have identified three types of E/M visits that differ 
from the typical E/M visit and are not appropriately reflected in the 
current office/outpatient E/M code set and valuation. Rather, these 
three types of E/M visits can be distinguished by the mode of care 
provided and, as a result, have different resource costs. The three 
types of E/M visits that differ from the typical E/M service are (1) 
separately identifiable E/M visits furnished in conjunction with a 0-
day global procedure, (2) primary care E/M visits for continuous 
patient care, and (3) certain types of specialist E/M visits, including 
those with inherent visit complexity. We address each of these 
distinguishable visit types in the following proposals.
d. Recognizing the Resource Costs for Different Types of E/M Visits
    Rather than maintain distinctions in services and payment that are 
based on the current E/M visit codes, we believe we can better capture 
differential resources costs and minimize reporting and documentation 
burden by proposing several corollary payment policies and ratesetting 
adjustments. These additional proposals better reflect the important 
distinctions between the kinds of visits furnished to Medicare 
beneficiaries, and would no longer require complex and burdensome 
billing and documentation rules to effectuate payment.
    In response to the CY 2018 comment solicitation on burden reduction 
for E/M visits (82 FR 53163 through 53166), we received several 
comments that highlighted the inadequacy of the E/M code set to 
accurately pay for the resources associated with furnishing visits, 
particularly for primary care visits, and visits associated with 
treating patients with particular conditions for which there is not 
additional procedural coding. One commenter stated that the current 
structure and valuation of the E/M code set inadequately describes the 
range of services provided by different specialties, and in particular 
primary care services. This commenter noted that although the 10 
office/outpatient E/M codes make up the bulk of the services reported 
by primary care practitioners, the valuation does not reflect their 
particular resource costs. Another commenter pointed out that for 
specialties that principally rely on E/M visit codes to bill for their 
professional services, the complex medical decision making and the 
intensity of their visits is not reflected in the E/M code set or 
documentation guidelines. Additionally, we believe that when a 
separately identifiable visit is furnished in conjunction with a 
procedure, that there are certain duplicative resource costs that are 
also not accounted for by current coding and payment.
    Therefore, we are proposing the following adjustments to better 
capture the variety of resource costs associated with different types 
of care provided in E/M visits: (1) An E/M multiple procedure payment 
adjustment to account for duplicative resource costs when E/M visits 
and procedures with global periods are furnished together; (2) HCPCS G-
code add-ons to recognize additional relative resources for primary 
care visits and inherent visit complexity that require additional work 
beyond that which is accounted for in the single payment rates for new 
and established patient levels 2 through level 5 visits; (3) HCPCS G-
codes to describe podiatric E/M visits; (4) an additional prolonged 
face-to-face services add-on G code; and (5) a technical modification 
to the PE methodology to stabilize the allocation of indirect PE for 
visit services (i) Accounting for E/M Resource Overlap between Stand-
Alone Visits and Global Periods
    Under the PFS, E/M services are generally paid in one of two ways: 
As standalone visits using E/M visit codes, or included in global 
procedural codes. In both cases, RVUs are allocated to the services to 
account for the estimated relative resources involved in furnishing 
professional E/M services. In the case of procedural codes with global 
periods,

[[Page 35841]]

the overall resource inputs reflect the costs of the E/M work 
considered to be typically furnished with the procedure. Therefore, the 
standalone E/M visit codes are not billable on the same day as the 
procedure codes unless the billing professional specifically indicates 
that the visit is separately identifiable from the procedure.
    In cases where a physician furnishes a separately identifiable E/M 
visit to a beneficiary on the same day as a procedure, payment for the 
procedure and the E/M visit is based on rates generally developed under 
the assumption that these services are typically furnished 
independently. In CY 2017 PFS rulemaking, we noted that the current 
valuation for services with global periods may not accurately reflect 
much of the overlap in resource costs (81 FR 80209). We are 
particularly concerned that when a standalone E/M visit occurs on the 
same day as a 0-day global procedure, there are significant overlapping 
resource costs that are not accounted for. We believe that separately 
identifiable visits occurring on the same day as 0-day global 
procedures have resources that are sufficiently distinct from the costs 
associated with furnishing one of the 10 office/outpatient E/M visits 
to warrant payment adjustment. There are other existing policies under 
the PFS where we reduce payments if multiple procedures are furnished 
on the same day to the same patient. Medicare has a longstanding policy 
to reduce payment by 50 percent for the second and subsequent surgical 
procedures furnished to the same patient by the same physician on the 
same day, largely based on the presence of efficiencies in PE and pre- 
and post-surgical physician work. Effective January 1, 1995, the MPPR 
policy, with the same percentage reduction, was extended to nuclear 
medicine diagnostic procedures (CPT codes 78306, 78320, 78802, 78803, 
78806, and 78807). In the CY 1995 PFS final rule with comment period 
(59 FR 63410), we indicated that we would consider applying the policy 
to other diagnostic tests in the future. In the CYs 2009 and 2010 PFS 
proposed rules (73 FR 38586 and 74 FR 33554, respectively), we stated 
that we planned to analyze nonsurgical services commonly furnished 
together (for example, 60 to 75 percent of the time) to assess whether 
an expansion of the MPPR policy could be warranted. MedPAC encouraged 
us to consider duplicative physician work, as well as PE, in any 
expansion of the MPPR policy. Finally, in the CY 2011 PFS final rule, 
CMS finalized the application of the MPPR to always-therapy services on 
the justification that there was significant overlap in the PE portion 
of these services (75 FR 73233).
    Using the surgical MPPR as a template, we are proposing that, as 
part of our proposal to make payment for the E/M levels 2 through 5 at 
a single PFS rate, we would reduce payment by 50 percent for the least 
expensive procedure or visit that the same physician (or a physician in 
the same group practice) furnishes on the same day as a separately 
identifiable E/M visit, currently identified on the claim by an 
appended modifier -25. We believe that the efficiencies associated with 
furnishing an E/M visit in combination with a same-day procedure are 
similar enough to those accounted for by the surgical MPPR to merit a 
reduction in the relative resources of 50 percent. We estimate based on 
CY 2017 Medicare claims data that applying a 50 percent MPPR to E/M 
visits furnished as separately identifiable services in the same day as 
a procedure would reduce expenditures under the PFS by approximately 
6.7 million RVUs. To accurately reflect resource costs of the different 
types of E/M visits that we previously identified while maintaining 
work budget neutrality within this proposal, we are proposing to 
allocate those RVUs toward the values of the add-on codes that reflect 
the additional resources associated with E/M visits for primary care 
and inherent visit complexity, similar to existing policies. As we 
articulated in the CY 2012 PFS final rule with comment period, where 
the aggregate work RVUs within a code family change but the overall 
actual physician work associated with those services does not change, 
we make work budget neutrality adjustments to hold the aggregate work 
RVUs constant within the code family, while maintaining the relativity 
of values for the individual codes within that set (76 FR 73105).
(ii) Proposed HCPCS G-Code Add-Ons To Recognize Additional Relative 
Resources for Certain Kinds of Visits
    The distribution of E/M visits is not uniform across medical 
specialties. We have found that certain specialists, like neurologists 
and endocrinologists, for example, bill higher level E/M codes more 
frequently than procedural specialists, such as dermatology. We believe 
this tendency reflects a significant and important distinction between 
the kinds of visits furnished by professionals whose treatment 
approaches are primarily reported using visit codes versus those 
professionals whose treatment approaches are primarily reported using 
available procedural or testing codes. However, based on feedback we 
received from the medical professionals who furnish primary care and 
have visits with greater complexity, such as the comments cited above, 
we do not believe the current visit definitions and the associated 
documentation burdens are the most accurate descriptions of the 
variation in work. Instead, we believe these professionals have been 
particularly burdened by the documentation requirements given that so 
much of their medical treatment is described imperfectly by relatively 
generic visit codes.
    Similarly stakeholders, such as the commenters responding to the CY 
2018 PFS proposed rule, have articulated persuasively that visits 
furnished for the purpose of primary care also involve distinct 
resource costs. In developing this proposal, we consulted a variety of 
resources, including the American Academy of Family Physicians (AAFP) 
definition of primary care that states that the resource costs 
associated with furnishing primary care services particularly include 
time spent coordinating patient care, collaborating with other 
physicians, and communicating with patients (see https://www.aafp.org/about/policies/all/primary-care.html). Despite our efforts in recent 
years to pay separately for certain aspects of primary care services, 
such as through the chronic care management or the transitional care 
management services, the currently available coding still does not 
adequately reflect the full range of primary care services, nor does it 
allow payment to fully capture the resource costs involved in 
furnishing a face-to-face primary care E/M visit. We recognize that 
primary care services frequently involve substantial non-face-to-face 
work, and note that there is currently coding available to account for 
many of those resources, such as chronic care management (CCM), 
behavioral health integration (BHI), and prolonged non-face-to-face 
services. In light of the existing coding, this proposal only addresses 
the additional resources involved in furnishing the face-to-face 
portion of a primary care service. As the point of entry for many 
patients into the healthcare system, primary care visits frequently 
require additional time for communicating with the patient, patient 
education, consideration and review of the patient's medical needs. We 
believe the proposed value for the single payment rate for the E/M 
levels 2 through 5 new and established patient visit codes does

[[Page 35842]]

not reflect these additional resources inherent to primary care visits, 
as evidenced by the fact that primary care visits are generally 
reported using level 4 E/M codes Therefore, to more accurately account 
for the type and intensity of E/M work performed in primary care-
focused visits, we are proposing to create a HCPCS add-on G-code that 
may be billed with the generic E/M code set to adjust payment to 
account for additional costs beyond the typical resources accounted for 
in the single payment rate for the levels 2 through 5 visits.
    We are proposing to create a HCPCS G-code for primary care 
services, GPC1X (Visit complexity inherent to evaluation and management 
associated with primary medical care services that serve as the 
continuing focal point for all needed health care services (Add-on 
code, list separately in addition to an established patient evaluation 
and management visit)). As we believe a primary care visit is partially 
defined by an ongoing relationship with the patient, this code would 
describe furnishing a visit to an established patient. HCPCS code GPC1X 
can also be reported for other forms of face-to-face care management, 
counseling, or treatment of acute or chronic conditions not accounted 
for by other coding. We note that we believe the additional resources 
to address inherent complexity in E/M visits associated with primary 
care services are associated only with stand-alone E/M visits as 
opposed to separately identifiable visits furnished within the global 
period of a procedure. Separately identifiable visits furnished within 
a global period are identified on the claim using modifier -25, and 
would be subject to the MPPR. We note that we have created separate 
coding that describes non-face-to-face care management and 
coordination, such as CCM and BHI; however, these services describe 
non-face-to-face care and can be provided by any specialty so long as 
they meet the requirements for those codes. HCPCS code GPC1X is 
intended to capture the additional resource costs, beyond those 
involved in the base E/M codes, of providing face-to-face primary care 
services for established patients. HCPCS code GPC1X would be billed in 
addition to the E/M visit for an established patient when the visit 
includes primary care services. For HCPCS code GPC1X, we are proposing 
a work RVU of 0.07, physician time of 1.75 minutes, a PE RVU of 0.07, 
and an MP RVU of 0.01. This proposed valuation accounts for the 
additional resource costs associated with furnishing primary care that 
distinguishes E/M primary care visits from other types of E/M visits, 
and maintains work budget neutrality across the office/outpatient E/M 
code set. Furthermore, the proposed add-on G-code for primary care-
focused E/M services would help to mitigate potential payment 
instability that could result from our adoption of single payment rates 
that apply for E/M code levels 2 through 5. As this add-on G-code would 
account for the inherent resource costs associated with furnishing 
primary care E/M services, we anticipate that it would be billed with 
every primary care-focused E/M visit for an established patient. While 
we expect that this code will mostly be utilized by the primary care 
specialties, such as family practice or pediatrics, we are also aware 
that, in some instances, certain specialists function as primary care 
practitioners--for example, an OB/GYN or a cardiologist. Although the 
definition of primary care is widely agreed upon by the medical 
community and we intend for this G-code to account for the resource 
costs of performing those types of visits, regardless of Medicare 
enrollment specialty, we are also seeking comment on how best to 
identify whether or not a primary care visit was furnished particularly 
in cases where a specialist is providing those services. For especially 
complex patients, we also expect that it may be billed alongside the 
proposed new code for prolonged E/M services described later in this 
section. We are also seeking comment on whether this policy adequately 
addresses the deficiencies in CPT coding for E/M services in describing 
current medical practice, and concerns about the impact on payment for 
primary care and other services under the PFS. Given the broad scope of 
our proposals related to E/M services, we are seeking feedback on any 
unintended consequences of those proposals. We are also seeking comment 
on any other concerns related to primary care that we might consider 
for future rulemaking.
    We are also proposing to create a HCPCS G-code to be reported with 
an E/M service to describe the additional resource costs for specialty 
professionals for whom E/M visit codes make up a large percentage of 
their overall allowed charges and whose treatment approaches we believe 
are generally reported using the level 4 and level 5 E/M visit codes 
rather than procedural coding. Due to these factors, the proposed 
single payment rate for E/M levels 2 through 5 visit codes would not 
necessarily reflect the resource costs of those types of visits. 
Therefore, we are proposing to create a new HCPCS code GCG0X (Visit 
complexity inherent to evaluation and management associated with 
endocrinology, rheumatology, hematology/oncology, urology, neurology, 
obstetrics/gynecology, allergy/immunology, otolaryngology, cardiology, 
or interventional pain management-centered care (Add-on code, list 
separately in addition to an evaluation and management visit)). Given 
their billing patterns, we believe that these are specialties that 
apply predominantly non-procedural approaches to complex conditions 
that are intrinsically diffuse to multi-organ or neurologic diseases. 
While some of these specialties are surgical in nature, we believe 
these surgical specialties are providing increased non-procedural care 
of high complexity in the Medicare population. The high complexity of 
these services is reflected in the large proportion of level 4 and 
level 5 visits that we believe are reported by these specialties, and 
the extent to which E/M visits are a high proportion of these 
specialties' total allowed charges. Consequently, these are specialties 
for which the resource costs of the visits they typically perform are 
not fully captured in the proposed single payment rate for the levels 2 
through level 5 office/outpatient visit codes. When billed in 
conjunction with standalone office/outpatient E/M visits for new and 
established patients, the combined valuation more accurately accounts 
for the intensity associated with higher level E/M visits. To establish 
a value for this add-on service to be applied with a standalone E/M 
visit, we are proposing a crosswalk to 75 percent of the work and time 
of CPT code 90785 (Interactive complexity), which results in a work RVU 
of 0.25, a PE RVU of 0.07, and an MP RVU of 0.01, as well as 8.25 
minutes of physician time based on the CY 2018 valuation for CPT code 
90785. Interactive complexity is an add-on code that may be billed when 
a psychotherapy or psychiatric service requires more resources due to 
the complexity of the patient. We believe that the proposed valuation 
for CPT code 90785 would be an accurate representation of the 
additional work associated with the higher level complex visits. We 
note that we believe the additional resources to address inherent 
complexity in E/M visits are associated with stand-alone E/M visits. 
Additionally, we acknowledge that resource costs for primary care are 
reflected with the proposed HCPCS code GPC1X, as opposed to the

[[Page 35843]]

proposed HCPCS code GCG0X. We note that there are additional codes 
available that include face-to-face and non-face-to-face work, 
depending on the code, that previously would have been considered part 
of an E/M visit, such as the codes for CCM, BHI, and CPT code 99483 
(Assessment of and care planning for a patient with cognitive 
impairment, requiring an independent historian, in the office or other 
outpatient, home or domiciliary or rest home, with all of the following 
required elements: Cognition-focused evaluation including a pertinent 
history and examination; Medical decision making of moderate or high 
complexity; Functional assessment (e.g., basic and instrumental 
activities of daily living), including decision-making capacity; Use of 
standardized instruments for staging of dementia (e.g., functional 
assessment staging test [FAST], clinical dementia rating [CDR]); 
Medication reconciliation and review for high-risk medications; 
Evaluation for neuropsychiatric and behavioral symptoms, including 
depression, including use of standardized screening instrument(s); 
Evaluation of safety (e.g., home), including motor vehicle operation; 
Identification of caregiver(s), caregiver knowledge, caregiver needs, 
social supports, and the willingness of caregiver to take on caregiving 
tasks; Development, updating or revision, or review of an Advance Care 
Plan; Creation of a written care plan, including initial plans to 
address any neuropsychiatric symptoms, neuro-cognitive symptoms, 
functional limitations, and referral to community resources as needed 
(e.g., rehabilitation services, adult day programs, support groups) 
shared with the patient and/or caregiver with initial education and 
support. Typically, 50 minutes are spent face-to-face with the patient 
and/or family or caregiver), which were developed to reflect the 
additional work of those practitioners furnishing primary care visits. 
Likewise, we are proposing that practitioners in the specialty of 
psychiatry would not use either add-on code because psychiatrists may 
utilize CPT code 90785 to describe work that might otherwise be 
reported with a level 4 or level 5 E/M visit.
    We are seeking comment on both of these proposals.
(iii) Proposed HCPCS G-Code To Describe Podiatric E/M Visits
    As described earlier, the vast majority of podiatric visits are 
reported using lower level E/M codes, with most E/M visits billed at a 
level 2 or 3, reflecting the type of work done by podiatrists as part 
of an E/M visit. Therefore, while the proposed consolidation of 
documentation and payment for E/M code levels 2 through 5 is intended 
to better reflect the universal elements of E/M visits across 
specialties and patients, we believe that podiatric E/M visits are not 
accurately represented by the consolidated E/M structure. In order for 
payment to reflect the resource costs of podiatric visits, we are also 
proposing to create two HCPCS G-codes, HCPCS codes GPD0X (Podiatry 
services, medical examination and evaluation with initiation of 
diagnostic and treatment program, new patient) and GPD1X (Podiatry 
services, medical examination and evaluation with initiation of 
diagnostic and treatment program, established patient), to describe 
podiatric E/M services. Under this proposal, podiatric E/M services 
would be billed using these G-codes instead of the generic office/
outpatient E/M visit codes (CPT codes 99201 through 99205 and 99211 
through 99215). We propose to create these separate G-codes for 
podiatric E/M services to differentiate the resources associated with 
podiatric E/M visits rather than proposing a negative add-on adjustment 
relative to the proposed single payment rates for the generic E/M 
levels 2 through 5 codes. Therefore, we are proposing to create 
separate coding to describe these services, taking into account that 
most podiatric visits are billed as level 2 or 3 E/M codes. We based 
the coding structure and code descriptor on CPT codes 92004 
(Ophthalmological services: Medical examination and evaluation with 
initiation of diagnostic and treatment program; comprehensive, new 
patient, 1 or more visits) and 92012 (Ophthalmological services: 
medical examination and evaluation, with initiation or continuation of 
diagnostic and treatment program; intermediate, established patient), 
which describe visits specific to ophthalmology. To accurately reflect 
payment for the resource costs associated with podiatric E/M visits, we 
are proposing a work RVU of 1.35, a physician time of 28.11 minutes, 
and direct PE inputs totaling $22.53 for HCPCS code GPD0X, and a work 
RVU of 0.85, physician time of 21.60 minutes, and direct PE inputs 
totaling $17.07 for HCPCS code GPD1X. These values are based on the 
average rate for the level 2 and 3 E/M codes (CPT codes 99201-99203 and 
CPT codes 99211-99212, respectively), weighted by podiatric volume.
(iv) Proposed Adjustment to the PE/HR Calculation
    As we explain in section II.B. Determination of Practice Expense 
(PE) Relative Value Units (RVUs), of this proposed rule, we generally 
allocate indirect costs for each code on the basis of the direct costs 
specifically associated with a code and the greater of either the 
clinical labor costs or the work RVUs. Indirect expenses include 
administrative labor, office expense, and all other PEs that are not 
directly attributable to a particular service for a particular patient. 
Generally, the proportion of indirect PE allocated to a service is 
determined by calculating a PE/HR based upon the mix of specialties 
that bill for a service.
    As described earlier, E/M visits comprise a significant portion of 
allowable charges under the PFS and are used broadly across specialties 
such that our proposed changes can greatly impact the change in payment 
at the specialty level and at the practitioner level. Our proposals 
seek to simplify payment for E/M visit levels 2 through 5, and to 
additionally take into consideration that there are inherent 
differences in primary care-focused E/M services and in more complex E/
M services such that those visits involve greater relative resources, 
while seeking to maintain overall payment stability across specialties. 
However, establishing a single PFS rate for new and established patient 
E/M levels 2 through-5 would have a large and unintended effect on many 
specialties due to the way that indirect PE is allocated based on the 
mixture of specialties that furnish a service. The single payment rates 
proposed for E/M levels 2 through 5 cannot reflect the indirect PE 
previously allocated differentially across those 8 codes. Historically, 
a broad blend of specialties and associated PE/HR has been used in the 
allocation of indirect PE and MP RVUs to E/M services to determine 
payment rates for these services. As this proposal significantly alters 
the PE/HR allocation for the office/outpatient E/M codes and any 
previous opportunities for the public to comment on the data would not 
have applied to these kinds of E/M services, we do not believe it is in 
the public interest to allow the allocation of indirect PE to have such 
an outsized impact on the payment rates for this proposal. Due to the 
magnitude of the proposed coding and payment changes for E/M visits, it 
is unclear how the distribution of specialties across E/M services 
would change. We are concerned that such changes could produce 
anomalous results for indirect PE allocations since we do not yet know 
the extent to which specialties would utilize the proposed simplified 
E/M codes and proposed G-codes. In the past, when utilization data are 
not

[[Page 35844]]

available or do not accurately reflect the expected specialty mix of a 
new service, we have proposed to crosswalk the PE/HR value from another 
specialty (76 FR 73036). As such, we are proposing to create a single 
PE/HR value for E/M visits (including all of the proposed HCPCS G-codes 
discussed above) of approximately $136, based on an average of the PE/
HR across all specialties that bill these E/M codes, weighted by the 
volume of those specialties' allowed E/M services. We believe that this 
is consistent with the methodology used to develop the inputs for the 
proposed simplified E/M payment for the levels 2 through 5 E/M visit 
codes, and that, for purposes of consistency, the new PE/HR should be 
applied across the additional E/M codes. We believe a new PE/HR value 
would more accurately reflect the mix of specialties billing both the 
generic E/M code set and the add-on codes. If we finalize this 
proposal, we will consider revisiting the PE/HR after several years of 
claims data become available.
(v) Proposed HCPCS G-Code for Prolonged Services
    Time is often an important determining factor in the level of care, 
which we consider in our proposal described earlier that physicians and 
other practitioners can use time as the basis for documenting and 
billing the appropriate level of E/M visit for purposes of Medicare 
payment. Currently there is inadequate coding to describe services 
where the primary resource of a service is physician time. CPT codes 
99354 (Prolonged evaluation and management or psychotherapy service(s) 
(beyond the typical service time of the primary procedure) in the 
office or other outpatient setting requiring direct patient contact 
beyond the usual service; first hour (List separately in addition to 
code for office or other outpatient Evaluation and Management or 
psychotherapy service)) and 99355 (Prolonged evaluation and management 
or psychotherapy service(s) (beyond the typical service time of the 
primary procedure) in the office or other outpatient setting requiring 
direct patient contact beyond the usual service; each additional 30 
minutes (List separately in addition to code for prolonged service)) 
describe additional time spent face-to-face with a patient and may be 
billed when the applicable amount of time exceeds the typical service 
time of the primary procedure.
    Stakeholders have informed CMS that the ``first hour'' time 
threshold in the descriptor for CPT code 99354 is difficult to meet and 
is an impediment to billing these codes (81 FR 80228). In response to 
stakeholder feedback and as part of our proposal to implement a single 
payment rate for E/M visit levels 2 through 5 while maintaining payment 
accuracy across the specialties, we are proposing to create a new HCPCS 
code GPRO1 (Prolonged evaluation and management or psychotherapy 
service(s) (beyond the typical service time of the primary procedure) 
in the office or other outpatient setting requiring direct patient 
contact beyond the usual service; 30 minutes (List separately in 
addition to code for office or other outpatient Evaluation and 
Management or psychotherapy service)). Given that the physician time of 
HCPCS code GPRO1 is half of the physician time assigned to CPT code 
99354, we are proposing a work RVU of 1.17, which is half the work RVU 
of CPT code 99354.
    In order to estimate the potential impact of these proposed 
changes, we modeled the results of several options and examined the 
estimated resulting impacts in overall Medicare allowed charges by 
physician specialty. In order to isolate the potential impact of these 
changes from other concurrent proposed changes, we conducted this 
analysis largely using the code set, policies, and input data that we 
developed in establishing PFS rates for CY 2018. However, we used the 
suite of ratesetting programs that included several updates relevant 
for CY 2019 rulemaking. Consequently, we conducted our analysis 
regarding potential specialty-level impacts in order to identify the 
specialties with allowed charges most likely to be impacted by the 
potential change. We believe these estimates illustrate the magnitude 
of potential changes for certain physician specialties. However, 
because our modeling did not account for the full range of technical 
changes in the input data used in PFS ratesetting, the potential 
impacts for these isolated policies are relatively imprecise, 
especially compared to the specialty-level impacts displayed in section 
VII. of this proposed rule.
    Tables 21, 22, and 23 show the estimated changes, for certain 
physician specialties, and isolated from other proposed changes, in 
expenditures for PFS services based on potential changes for E/M coding 
and payment. We note that we are making additional data available to 
the public to inform our modeling on our E/M coding and payment 
proposals, available on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/.

 Table 21--Unadjusted Estimated Specialty Impacts of Proposed Single RVU
          Amounts for Office/Outpatient E/M 2 Through 5 Levels
------------------------------------------------------------------------
                                                     Estimated potential
                                        Allowed       impact of valuing
             Specialty               charges  (in   levels 2-5 together,
                                       millions)     without additional
                                                         adjustments
------------------------------------------------------------------------
PODIATRY..........................          $2,022  12%.
DERMATOLOGY.......................           3,525  7%.
HAND SURGERY......................             202  6%.
OTOLARNGOLOGY.....................           1,220  5%.
ORTHOPEDIC SURGERY................           3,815  4%.
ORAL/MAXILLOFACIAL SURGERY........              57  4%.
COLON AND RECTAL SURGERY..........             168  Less than 3%
                                                     estimated increase
                                                     in overall payment.
OBSTETRICS/GYNECOLOGY.............             664
OPTOMETRY.........................           1,276
PHYSICIAN ASSISTANT...............           2,253
PLASTIC SURGERY...................             387
ALLERGY/IMMUNOLOGY................             240  Minimal change to
                                                     overall payment.
ANESTHESIOLOGY....................           1,995
AUDIOLOGIST.......................              67
CARDIAC SURGERY...................             313

[[Page 35845]]

 
CHIROPRACTOR......................             789
CRITICAL CARE.....................             334
EMERGENCY MEDICINE................           3,196
FAMILY PRACTICE...................           6,382
GASTROENTEROLOGY..................           1,807
GENERAL PRACTICE..................             461
GENERAL SURGERY...................           2,182
INFECTIOUS DISEASE................             663
INTERVENTIONAL PAIN MGMT..........             839
INTERVENTIONAL RADIOLOGY..........             362
MULTISPECIALTY CLINIC/OTHER PHYS..             141
NEUROSURGERY......................             812
NUCLEAR MEDICINE..................              50
NURSE PRACTITIONER................           3,586
OPHTHALMOLOGY.....................           5,542
OTHER.............................              30
PATHOLOGY.........................           1,151
PHYSICAL MEDICINE.................           1,120
PSYCHIATRY........................           1,260
RADIATION ONCOLOGY AND RADIATION             1,776
 THERAPY CENTERS.
RADIOLOGY.........................           4,898
THORACIC SURGERY..................             360
UROLOGY...........................           1,772
VASCULAR SURGERY..................           1,132
CARDIOLOGY........................           6,723  Less than 3%
                                                     estimated decrease
                                                     in overall payment.
INTERNAL MEDICINE.................          11,173
NEPHROLOGY........................           2,285
PEDIATRICS........................              64
PULMONARY DISEASE.................           1,767
GERIATRICS........................             214  -4%.
RHEUMATOLOGY......................             559  -7%.
NEUROLOGY.........................           1,565  -7%.
HEMATOLOGY/ONCOLOGY...............           1,813  -7%.
ENDOCRINOLOGY.....................             482  -10%.
                                   -------------------------------------
    TOTAL.........................          93,486  0.
------------------------------------------------------------------------

    Table 21 characterizes the estimated overall impact for certain 
physician specialties, of establishing single payment rates for the new 
and established patient E/M code levels 2 through 5, without any of the 
additional coding or proposed payment adjustments, including the 
estimated percentage change for the specialties with an estimated 
increase or decrease in payment greater than 3 percent. Those 
specialties that tend to bill lower level E/M visits would benefit the 
most from the proposed change to single PFS payment rates, while those 
specialties that tend to bill more higher level E/M visits would see 
the largest decreases in payment with the change to a single PFS rate. 
The single payment rate for E/M code levels 2 through 5 would benefit 
podiatry the most because, due to the nature of most podiatric E/M 
visits, they tend to bill only level 2 and 3 E/M visits.

     Table 22--Specialty Specific Impacts Including Payment Accuracy
                               Adjustments
------------------------------------------------------------------------
                                                     Estimated potential
                                        Allowed       impact of valuing
             Specialty               charges  (in   levels 2-5 together,
                                       millions)       with additional
                                                         adjustments
------------------------------------------------------------------------
OBSTETRICS/GYNECOLOGY.............            $664  4%.
NURSE PRACTITIONER................           3,586  3%.
HAND SURGERY......................             202  Less than 3%
                                                     estimated increase
                                                     in overall payment.
INTERVENTIONAL PAIN MGMT..........             839
OPTOMETRY.........................           1,276
PHYSICIAN ASSISTANT...............           2,253
PSYCHIATRY........................           1,260
UROLOGY...........................           1,772
ANESTHESIOLOGY....................           1,995  Minimal change to
                                                     overall payment.
CARDIAC SURGERY...................             313
CARDIOLOGY........................           6,723
CHIROPRACTOR......................             789

[[Page 35846]]

 
COLON AND RECTAL SURGERY..........             168
CRITICAL CARE.....................             334
EMERGENCY MEDICINE................           3,196
ENDOCRINOLOGY.....................             482
FAMILY PRACTICE...................           6,382
GASTROENTEROLOGY..................           1,807
GENERAL PRACTICE..................             461
GENERAL SURGERY...................           2,182
GERIATRICS........................             214
INFECTIOUS DISEASE................             663
INTERNAL MEDICINE.................          11,173
INTERVENTIONAL RADIOLOGY..........             362
MULTISPECIALTY CLINIC/OTHER PHYS..             141
NEPHROLOGY........................           2,285
NEUROSURGERY......................             812
NUCLEAR MEDICINE..................              50
OPHTHALMOLOGY.....................           5,542
ORAL/MAXILLOFACIAL SURGERY........              57
ORTHOPEDIC SURGERY................           3,815
OTHER.............................              30
PATHOLOGY.........................           1,151
PEDIATRICS........................              64
PHYSICAL MEDICINE.................           1,120
PLASTIC SURGERY...................             387
RADIOLOGY.........................           4,898
THORACIC SURGERY..................             360
VASCULAR SURGERY..................           1,132
ALLERGY/IMMUNOLOGY................             240  Less than 3%
                                                     estimated decrease
                                                     in overall payment.
AUDIOLOGIST.......................              67
HEMATOLOGY/ONCOLOGY...............           1,813
NEUROLOGY.........................           1,565
OTOLARNGOLOGY.....................           1,220
PULMONARY DISEASE.................           1,767
RADIATION ONCOLOGY AND RADIATION             1,776
 THERAPY CENTERS.
RHEUMATOLOGY......................             559  -3.
DERMATOLOGY.......................           3,525  -4.
PODIATRY..........................           2,022  -4.
                                   -------------------------------------
    TOTAL.........................          93,486  0.
------------------------------------------------------------------------

    Table 22 characterizes the estimated overall impact for certain 
physician specialties, including the proposed adjustments have been 
made to reflect the distinctions in resource costs among certain types 
of E/M visits. In other words, Table 22 shows the proposed impacts of 
adopting the proposed single payment rates for new and established 
patient E/M visit levels 2 through 5, the application of a MPPR to E/M 
visits when furnished by the same practitioner (or practitioner in the 
same practice) on the same-day as a global procedure code, the add-on 
G-codes for primary care-focused services and inherent visit 
complexity, and the technical adjustments to the PE/HR value. Table 22 
includes the estimated percentage change for the specialties with an 
estimated increase or decrease in payment greater than three percent. 
In our modeling, we assumed E/M visits for specialties that provide a 
significant portion of primary care like family practice, internal 
medicine, pediatrics and geriatrics utilized the G-code for visit 
complexity inherent to evaluation and management associated with 
primary medical care services with every office/outpatient visit 
furnished. Also for the purposes of our modeling, we assumed that 
specialties including endocrinology, rheumatology, hematology/oncology, 
urology, neurology, obstetrics/gynecology, allergy/immunology, 
otolaryngology, or interventional pain management-centered care 
utilized the G-code for visit complexity inherent to evaluation and 
management with every office/outpatient E/M visit. Table 22 does not 
include the impact of the use of the additional prolonged services 
code. The specialties that we estimate would experience a decrease in 
payments are those that bill a large portion of E/M visits on the same 
day as procedures, and would see a reduction based on the application 
of the MPPR adjustments. Some of these specialties, such as allergy/
immunology and cardiology are also negatively impacted by the proposed 
single payment rates themselves, although not to the same degree as 
they would have been without any adjustments to provide alternate 
coding to reflect their resource costs, as illustrated in Table 21. The 
specialties that we estimate will see an increase in payments from 
these proposals, like psychiatry, nurse practitioner, and 
endocrinology, are seeing payment increases due to a combination of the 
single payment rate and the add-on codes for inherent visit complexity.
    As an example, in CY 2018, a physician would bill a level 4 E/M 
visit and document using the existing documentation framework for a 
level 4 E/M visit. Their payment rate would be approximately $109 in 
the office setting.

[[Page 35847]]

If these proposals are finalized, the physician would bill the same 
visit code for a level 4 E/M visit, documenting the visit according to 
the minimum documentation requirements for a level 2 E/M visit and/or 
based on their choice of using time, MDM, or the 1995 or 1997 
guidelines, plus either of the proposed add-on codes (HCPCS codes GPC1X 
or GCG0X) depending on the type of patient care furnished, and could 
bill one unit of the proposed prolonged services code (HCPCS code 
GPRO1) if they meet the time threshold for this code. The combined 
payment rate for the generic E/M code and HCPCS code GPRO1 would be 
approximately $165 with HCPCS code GPC1X and approximately $177 with 
HCPCS code GCG0X.
    We welcome comments on all of these proposals.
(vi) Alternatives Considered
    We considered a number of other options for simplifying coding and 
payment for E/M services to align with the proposed reduction in 
documentation requirements and better account for the resources 
associated with inherent complexity, visit complexity, and visits 
furnished on the same day as a 0-day global procedure. For example, we 
considered establishing single payment rates for new and established 
patients for combined E/M visit levels 2 through 4, as opposed to 
combined E/M visit levels 2 through 5. This option would have retained 
a separately valued payment rate for level 5 visits that would be 
reserved for the most complex visits or patients. However, maintaining 
a separately valued payment rate for this higher level visit based on 
the current CPT code definition has the consequence of preserving some 
of the current coding distinctions within the billing systems. 
Ultimately we believe that providing for two levels of payment and 
documentation (setting aside level 1 visits which are primarily visits 
by clinical staff) relieves more burden than three levels, and that two 
levels plus the proposed add-on coding more accurately captures the 
differential resource costs involved in furnishing E/M services to all 
patients. If we retained a coding scheme involving three or more levels 
of E/M visits, it would not be appropriate to apply a minimum 
documentation requirement as we propose to do. We would need to develop 
documentation requirements unique to each of the higher level visits. 
There would be a greater need for program integrity mechanisms to 
prevent upcoding and ensure that practitioners who chose to report the 
highest level visit justified their selection of code level. We could 
still simplify the documentation requirements for E/M visits relative 
to the current framework, but would need a more extensive, differential 
documentation framework than what we propose in this rule, in order to 
distinguish among visit levels. We are interested in stakeholder input 
on the best number of E/M visit levels and how to best achieve a 
balance between number of visit levels and simpler, updated 
documentation rules. We are seeking input as to whether these two 
aspects of our proposals together can reduce burden and ensure accurate 
payment across the broad range of E/M visits, including those for 
complex and high need beneficiaries.

 Table 23--Unadjusted Estimated Specialty Impacts of Single PFS Rate for
                Office/Outpatient E/M Levels 2 Through 4
------------------------------------------------------------------------
                                                  Allowed
                  Specialty                       charges       Impact
                                                (millions)     (percent)
------------------------------------------------------------------------
Podiatry....................................          $2,022          10
Dermatology.................................           3,525           6
Hand Surgery................................             202           5
Oral/Maxillofacial Surgery..................              57           4
Otolaryngology..............................           1,220           4
Cardiology..................................           6,723          -3
Hematology/Oncology.........................           1,813          -3
Neurology...................................           1,565          -3
Rheumatology................................             559          -6
Endocrinology...............................             482          -8
------------------------------------------------------------------------
Note: All other specialty level impacts were within +/- 3%.

    Table 23 shows the specialties that would experience the greatest 
increase or decrease by establishing single payment rates for E/M visit 
levels 2 through 4, while maintaining the value of the level 1 and the 
level 5 E/M visits. The specialty level impacts are similar to those in 
Table 21 as the specialties that bill more higher level visits do not 
benefit by maintaining a distinct payment for the level 5 visit as much 
as they experience a reduction in the rate for a level 4 visit. 
Similarly, the specialties that bill predominantly lower level visits 
would still benefit disproportionally to the increase in rate for the 
level 2 and level 3 visits.
    Section 101(f) of the MACRA, enacted on April 16, 2015, added a new 
subsection (r) under section 1848 of the Act entitled Collaborating 
with the Physician, Practitioner, and Other Stakeholder Communities to 
Improve Resource Use Measurement. Section 1848(r) of the Act requires 
the establishment and use of classification code sets: Care episode and 
patient condition groups and codes; and patient relationship categories 
and codes. As described in the CY 2018 PFS final rule, we finalized use 
of Level II HCPCS Modifiers as the patient relationship codes and 
finalized that Medicare claims submitted for items and services 
furnished by a physician or applicable practitioner on or after January 
1, 2018, should include the applicable patient relationship codes, as 
well as the NPI of the ordering physician or applicable practitioner 
(if different from the billing physician or applicable practitioner). 
We noted that for CY 2018, reporting of the patient relationship 
modifiers would be voluntary and the use and selection of the modifiers 
would not be a condition of payment (82 FR 53234). The patient 
relationship codes are as follows: X1: Continuous/broad; X2: 
Continuous/focused; X3: Episodic/focused; X4: Episodic/broad; and X5: 
Only as ordered by another physician. These codes are to be used to 
help define and distinguish the relationship and responsibility of a 
clinician with a patient at the time of furnishing an item or service, 
facilitate the attribution of patients and episodes to one or more 
clinicians, and to allow clinicians to self-identify their patient 
relationships.
    We considered proposing the use of these codes to adjust payment 
for E/M visits to the extent that these codes are indicative of 
differentiated resources provided in E/M visits, and we considered 
using these codes as an alternative to the proposed use of G-codes to 
reflect visit complexity inherent to evaluation and management in 
primary care and certain other specialist services, as a way to more 
accurately reflect the resource costs associated with furnishing 
different kinds of E/M visits. We are seeking comment on this 
alternative. We are particularly interested in whether the modifiers 
would accurately reflect the differences between resources for E/M 
visits across specialties and would therefore be useful to adjust 
payment differentially for the different types of E/M visits that we 
previously identified.
e. Emergency Department and Other E/M Visit Settings
    As we mentioned above, the E/M visit code set is comprised of 
individual subsets of codes that are specific to various clinical 
settings including office/outpatient, observation, hospital inpatient, 
emergency department, critical care, nursing facility, domiciliary or 
rest home, and home services. Some of these code subsets have three E/M 
levels of care, while

[[Page 35848]]

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

J. Teaching Physician Documentation Requirements for Evaluation and 
Management Services

1. Background
    Per 42 CFR part 415, subpart D, Medicare Part B makes payment under 
the PFS for teaching physician services when certain conditions are 
met, including that medical record documentation must reflect the 
teaching physician's participation in the review and direction of 
services performed by residents in teaching settings. Under Sec.  
415.172(b), for certain procedural services, the participation of the 
teaching physician may be demonstrated by the notes in the medical 
records made by a physician, resident, or nurse; and for E/M visits, 
the teaching physician is required to personally document their 
participation in the medical record. We received stakeholder feedback 
suggesting that documentation requirements for E/M services furnished 
by teaching physicians are burdensome and duplicative of notations that 
may have previously been included in the medical records by residents 
or other members of the medical team.
2. Proposed Implementation
    We are proposing to revise our regulations to eliminate potentially 
duplicative requirements for notations that may have previously been 
included in the medical records by residents or

[[Page 35849]]

other members of the medical team. These proposed changes are intended 
to align and simplify teaching physician E/M service documentation 
requirements. We believe these proposed changes will reduce burden and 
duplication of effort for teaching physicians. We are proposing to 
amend Sec.  415.172(b) to provide that, except for services furnished 
as set forth in Sec. Sec.  415.174 (concerning an exception for 
services furnished in hospital outpatient and certain other ambulatory 
settings), 415.176 (concerning renal dialysis services), and 415.184 
(concerning psychiatric services), the medical records must document 
that the teaching physician was present at the time the service is 
furnished. Additionally, the revised paragraph would specify that the 
presence of the teaching physician during procedures and evaluation and 
management services may be demonstrated by the notes in the medical 
records made by a physician, resident, or nurse. We are also proposing 
to amend Sec.  415.174, by deleting paragraph (a)(3)(v) which currently 
requires the teaching physician to document the extent of their 
participation in the review and direction of the services furnished to 
each beneficiary, and adding new paragraph (a)(6), to provide that the 
medical record must document the extent of the teaching physician's 
participation in the review and direction of services furnished to each 
beneficiary, and that the extent of the teaching physician's 
participation may be demonstrated by the notes in the medical records 
made by a physician, resident, or nurse.

K. Solicitation of Public Comments on the Low Expenditure Threshold 
Component of the Applicable Laboratory Definition Under the Medicare 
Clinical Laboratory Fee Schedule (CLFS)

    Section 1834A of the Act, as established by section 216(a) of the 
Protecting Access to Medicare Act of 2014 (PAMA), required significant 
changes to how Medicare pays for clinical diagnostic laboratory tests 
(CDLTs) under the CLFS. The CLFS final rule titled, Medicare Clinical 
Diagnostic Laboratory Tests Payment System final rule (CLFS final 
rule), published in the Federal Register on June 23, 2016, implemented 
section 1834A of the Act. Under the CLFS final rule (81 FR 41036), 
``reporting entities'' must report to CMS during a ``data reporting 
period'' ``applicable information'' (that is, certain private payer 
data) collected for a ``data collection period'' for their component 
``applicable laboratories.'' In general, the payment amount for each 
CDLT on the CLFS furnished beginning January 1, 2018, is based on the 
applicable information collected for the 6-month data collection period 
and reported to us in the 3-month data reporting period, and is equal 
to the weighted median of the private payor rates for the CDLT.
    An applicable laboratory is defined at Sec.  414.502, in part, as 
an entity that is a laboratory (as defined under the Clinical 
Laboratory Improvement Amendments (CLIA) definition at Sec.  493.2) 
that bills Medicare Part B under its own National Provider Identifier 
(NPI). In addition, an applicable laboratory is an entity that receives 
more than 50 percent of its Medicare revenues during a data collection 
period from the CLFS and/or the PFS. We refer to this component of the 
applicable laboratory definition as the ``majority of Medicare revenues 
threshold.'' The definition of applicable laboratory also includes a 
``low expenditure threshold'' component, which requires an entity to 
receive at least $12,500 of its Medicare revenues from the CLFS in a 
data collection period for its CDLTs that are not advanced diagnostic 
laboratory tests (ADLTs).
    We established $12,500 as the low expenditure threshold because we 
believed it achieved a balance between collecting sufficient data to 
calculate a weighted median that appropriately reflects the private 
market rate for a CDLT, and minimizing the reporting burden for 
laboratories that receive a relatively small amount of revenues under 
the CLFS. In the CLFS final rule (81 FR 41051), we estimated that 95 
percent of physician office laboratories and 55 percent of independent 
laboratories would not be required to report applicable information 
under our low expenditure threshold criterion. Although we 
substantially reduced the number of laboratories qualifying as 
applicable laboratories (that is, approximately 5 percent of physician 
office laboratories and approximately 45 percent of independent 
laboratories) we estimated that the percentage of Medicare utilization 
would remain high. That is, approximately 5 percent of physician office 
laboratories would account for approximately 92 percent of CLFS 
spending on physician office laboratories and approximately 45 percent 
of independent laboratories would account for approximately 99 percent 
of CLFS spending on independent laboratories (81 FR 41051).
    Recently, we have heard from some laboratory stakeholders that the 
low expenditure threshold excludes most physician office laboratories 
and many small independent laboratories from reporting applicable 
information, and that by excluding so many laboratories, the payment 
rates under the new private payor rate-based CLFS reflects incomplete 
data, and therefore, inaccurate CLFS pricing. However, it is our 
understanding that physician offices are generally not prepared to 
identify, collect, and report each unique private payor rate from each 
private payor for each laboratory test code on the CLFS and the volume 
associated with each unique private payor rate. As such, we believe 
revising the low expenditure threshold so that more physician office 
laboratories are required to report applicable information would be a 
very significant administrative burden on physician's offices. We also 
believe that increasing participation from physician office 
laboratories would have minimal overall impact on payment rates given 
that the weighted median of private payor rates is dominated by the 
laboratories with the largest test volume.
    However, we recognize from stakeholders that some physician office 
laboratories and small independent laboratories that are not applicable 
laboratories because they do not meet the current low expenditure 
threshold may still want to report applicable information, despite the 
administrative burden associated with qualifying as an applicable 
laboratory. Therefore, we are seeking public comments on reducing the 
low expenditure threshold by 50 percent, from $12,500 to $6,250, in 
CLFS revenues during a data collection period. Since more physician 
office laboratories would meet the low expenditure threshold, we would 
expect such an approach to increase the level of applicable information 
reported by physician office laboratories and small independent 
laboratories. We are seeking public comments regarding the potential 
administrative burden on physician office laboratories and small 
independent laboratories that would result from reducing the low 
expenditure threshold. We are also soliciting public comments on an 
approach that would increase the low expenditure threshold by 50 
percent, from $12,500 to $18,750, in CLFS revenues received in a data 
collection period. Since fewer physician office laboratories and small 
independent laboratories would meet the definition of applicable 
laboratory, we would expect such an approach to result in a decreased 
level of applicable information reported. For a complete discussion of 
our solicitation of comments on the low expenditure threshold component 
of the definition

[[Page 35850]]

of applicable laboratory under the Medicare CLFS, we refer readers to 
section III.A. of this proposed rule.

L. GPCI Comment Solicitation

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

M. Therapy Services

1. Repeal of the Therapy Caps and Limitation To Ensure Appropriate 
Therapy
    Section 50202 of the Bipartisan Budget Act of 2018 (BBA of 2018) 
amended section 1833(g) of the Act, effective January 1, 2018, to 
repeal the application of the Medicare outpatient therapy caps and the 
therapy cap exceptions process while retaining and adding limitations 
to ensure therapy services are furnished when appropriate. Section 
50202 also adds section 1833(g)(7)(A) of the Act to require that after 
expenses incurred for the beneficiary's outpatient therapy services for 
the year have exceeded one or both of the previous therapy cap amounts, 
all therapy suppliers and providers must continue to use an appropriate 
modifier such as the KX modifier on claims for subsequent services in 
order for Medicare to pay for the services. We implemented this 
provision by continuing to use the KX modifier. By applying the KX 
modifier to the claim, the therapist or therapy provider is confirming 
that the services are medically necessary as justified by appropriate 
documentation in the medical record. Just as with the incurred expenses 
for the prior therapy cap amounts, there is one amount for physical 
therapy (PT) and speech language pathology (SLP) services combined and 
a separate amount for occupational therapy (OT) services. These KX 
modifier threshold amounts are indexed annually by the Medicare 
Economic Index (MEI). For CY 2018, this KX modifier threshold amount is 
$2,010 for PT and SLP services combined, and $2,010 for OT After the 
beneficiary's incurred expenditures for outpatient therapy services 
exceed the KX modifier threshold amount for the year, claims for 
outpatient therapy services without the KX modifier are denied.
    Along with the KX modifier thresholds, section 50202 also adds 
section 1833(g)(7)(B) of the Act that retains the targeted medical 
review (MR) process (first established through section 202 of the 
Medicare Access and CHIP Reauthorization Act of 2015 (MACRA)), but at a 
lower threshold amount of $3,000. For CY 2018 (and each successive 
calendar year until 2028, at which time it is indexed annually by the 
MEI), the MR threshold is $3,000 for PT and SLP services and $3,000 for 
OT services. The targeted MR process means that not all claims 
exceeding the MR threshold amount are subject to review as they once 
were.
    Section 1833(g)(8) of the Act, as redesignated by section 50202 of 
the BBA of 2018, retains the provider liability procedures which first 
became effective January 1, 2013, extending limitation of liability 
protections to beneficiaries who receive outpatient therapy services, 
when services are denied for certain reasons, including failure to 
include a necessary KX modifier.
2. Proposed Payment for Outpatient PT and OT Services Furnished by 
Therapy Assistants
    Section 53107 of the Bipartisan Budget Act of 2018 (BBA of 2018) 
amended the Act to add a new subsection 1834(v) that addresses payment 
for outpatient therapy services for which payment is made under section 
1848 or section 1834(k) of the Act that are furnished on or after 
January 1, 2022, in whole or in part by a therapy assistant (as defined 
by the Secretary). The new section 1834(v)(1) of the Act provides for 
payment of those services at 85 percent of the otherwise applicable 
Part B payment amount for the service. In accordance with section 
1834(v)(1) of the Act, the reduced payment amount for such outpatient 
therapy services is applicable when payment is made directly under the 
PFS as specified in section 1848 of the Act, for example when payment 
is made to therapists in private practice (TPPs); and when payment is 
made based on the PFS as specified in section 1834(k)(3) of the Act, 
for example, when payment is made for outpatient therapy services 
identified in sections 1833(a)(8) and (9) of the Act, including payment 
to providers that submit institutional claims for therapy services such 
as outpatient hospitals, rehabilitation agencies, skilled nursing 
facilities, home health agencies and comprehensive outpatient 
rehabilitation facilities (CORFs). The reduced payment rate under 
section 1834(v)(1) of the Act for outpatient therapy services when 
furnished in whole or in part by a therapy assistant is not applicable 
to outpatient therapy services furnished by critical access hospitals 
for which payment is made as specified in section 1834(g) of the Act.
    To implement this payment reduction, section 1834(v)(2)(A) of the 
Act requires us to establish a new modifier, in a form and manner 
specified by the Secretary, by January 1, 2019 to indicate, in the case 
of an outpatient therapy service furnished in whole or in part by a 
therapy assistant, that the service was furnished by a therapy 
assistant. Although we generally consider all genres of outpatient 
therapy services together (PT/OT/SLP), we do not believe there are 
``therapy assistants'' in the case of SLP services, so we propose to 
apply the new modifier only to services furnished in whole or in part 
by a physical therapist assistant (PTA) or an occupational therapist 
assistant (OTA). Section 1834(v)(2)(B) of the Act requires that each 
request for payment or bill submitted for an outpatient PT or OT 
service furnished in whole or in part by a therapy assistant on or 
after January 1, 2020, must include the established modifier. As such, 
the modifier will be required to be reported on claims for outpatient 
PT and OT services with dates of service on and after January 1, 2020, 
when the service is furnished in whole or in part by a therapy 
assistant, regardless of whether the reduced payment under section 
1834(v)(1) of the Act is applicable. However, the required payment 
reductions do not apply for these services until January 1, 2022, as 
required by section 1834(v)(1) of the Act.
    To implement this provision, we are proposing to establish two new 
modifiers to separately identify PT and OT services that are furnished 
in whole or in part by PTAs and OTAs,

[[Page 35851]]

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

[[Page 35852]]

minute of the outpatient therapy service that is therapeutic in nature, 
and that is provided by the PTA or OTA when acting as an extension of 
the therapist. Therefore, a service furnished ``in part'' by a therapy 
assistant would not include a service for which the PTA or OTA 
furnished only non-therapeutic services that others without the PTA's 
or OTA's training can do, such as scheduling the next appointment, 
greeting and gowning the patient, preparing or cleaning the room. We 
remind therapists and therapy providers that we do not recognize PTAs 
and OTAs to wholly furnish PT and OT evaluations and re-evaluations, 
that is, CPT codes 97161 through 97164 for PT and CPT codes 97165 
through 97168 for OT; but to the extent that they do furnish part of an 
evaluative service, the appropriate therapy modifier must be used on 
the claim to signal that the service was furnished in part by the PTA 
or OTA, and the payment reduction should be applied once it goes into 
effect. We continue to believe that the clinical judgment and decision 
making involved in furnishing an evaluation or re-evaluation is similar 
to that involved with establishing the therapy plan that can only be 
established by a therapist, physician, or NPP (NP, CNS, or PA) as 
specified in Sec.  410.61 of our regulations. In addition, PTAs and 
OTAs are not recognized separately in the statute to enroll as 
practitioners for purposes of independently billing for their services 
under the Medicare program. For these reasons, Pub. 100-02, Medicare 
Benefits Policy Manual, Chapter 15, sections 230.1 and 230.2 state that 
PTAs and OTAs ``. . . may not provide evaluative or assessment 
services, make clinical judgments or decisions; develop, manage, or 
furnish skilled maintenance program services; or take responsibility 
for the service.'' While we expect that the therapist will continue to 
furnish the majority of an evaluative procedure service, section 
1834(v)(1) of the Act requires that the adjusted payment amount (85 
percent of the otherwise applicable Part B payment amount) be applied 
when a therapy assistant furnishes a therapy service ``in part,'' 
including part of an evaluative service.
    Additionally, we would like to clarify that the requirements for 
evaluations, including those for documentation, are separate and 
distinct from those for plans of care (plans). The plan is a statutory 
requirement under section 1861(p) of the Act for outpatient PT services 
(and through sections 1861(g) and 1861(ll)(2) of the Act for outpatient 
OT and SLP services, respectively) and may only be established by a 
therapist or physician. Through Sec.  410.61(b)(5), NPs, CNSs, and PAs 
are also permitted to establish the plan. This means that if the 
evaluative procedure is furnished in part by an assistant, the new 
therapy modifiers that distinguish services furnished by PTAs or OTAs 
must be applied to the claim; however, the plan, which is not 
separately reported or paid, must be established by the supervising 
therapist who furnished part of the evaluation services as specified at 
Sec.  410.61(b). When an evaluative therapy service is billed by a 
physician or an NPP as the rendering provider, either the physician/NPP 
or the therapist furnishing the service incident to the services of the 
physician or NPP, may establish the therapy plan in accordance with 
Sec.  410.61(b). All regulatory and subregulatory plan requirements 
continue to apply.
    To implement the new statutory provision at section 1834(v)(2)(A) 
of the Act, we are proposing to establish two new therapy modifiers to 
identify the services furnished in whole or in part by PTAs and OTAs. 
As required under section 1834(v)(2)(B) of the Act, claims from all 
providers of PT and OT services furnished on and after January 1, 2020, 
will be required to include these new PT- and OT-Assistant therapy 
modifiers for services furnished in whole or in part by a PTA or OTA. 
We propose that these modifiers will be required, when applicable, in 
place of the GP and GO modifiers currently used to identify PT and OT 
services furnished under an outpatient plan of care. To test our 
systems ahead of the required implementation date of January 1, 2020, 
we anticipate allowing voluntary reporting of the new modifiers at some 
point during CY 2019, which we will announce to our contractors and 
therapy providers through a Change Request, as part of our usual change 
management process.
    We seek comments on these proposals.
3. Proposed Functional Reporting Modifications
    Since January 1, 2013, all providers of outpatient therapy 
services, including PT, OT, and SLP services, have been required to 
include functional status information on claims for therapy services. 
In response to the Request for Information (RFI) on CMS Flexibilities 
and Efficiencies that was issued in the CY 2018 PFS proposed rule (82 
FR 34172 through 34173), we received comments requesting burden 
reduction related to the reporting of the functional reporting 
requirements that were adopted to implement the requirements of section 
3005(g) of the Middle Class Tax Relief and Jobs Creation Act (MCTRJCA) 
of 2012, effective January 1, 2013.
    After considering comments received through the CY 2013 PFS final 
rule with comment period (77 FR 68598-68978), we finalized the design 
of the functional reporting system. The MCTRJCA required us to 
implement a claims-based data collection strategy in order to collect 
data on patient function over the course of PT, OT, and SLP services in 
order to better understand patient condition and outcomes. The 
functional reporting system we implemented collects data using non-
payable HCPCS G-codes (HCPCS codes G8978 through G8999 and G9158 
through G9186) and modifiers (in the range CH through CN) to describe a 
patient's functional limitation and severity at: (a) The time of the 
initial service, (b) at periodic intervals in sync with existing 
progress reporting intervals, (c) at discharge, and (d) when reporting 
certain evaluative and re-evaluative procedures (often times billed at 
time of initial service). Claims without the required functional 
reporting information are returned to therapy services providers, 
rather than denied, so that they can add the required information and 
resubmit claims. Therapy services providers must also document 
functional reporting information in the patient's medical record each 
time it is reported. The MCTRJCA also specified that data from the 
functional reporting system were to be used to aid us in recommending 
changes to, and reforming Medicare payment for outpatient therapy 
services that were then subject to the therapy caps under section 
1833(g) of the Act. We conducted an analysis that focused on the 
functional reporting data that have been submitted through the claims-
based system, both by therapy discipline and by episodes of care by 
discipline using a similar episode definition (for example, clean 60 
calendar day period) that was used in our prior utilization reports for 
CY 2008 through CY 2010 that can be found on the Therapy Services web 
page in the Studies and Reports page at https://www.cms.gov/Medicare/Billing/TherapyServices/Studies-and-Reports.html). However, we did not 
find the results compelling enough to use as a basis to recommend or 
undertake administrative reforms of the current payment mechanism for 
therapy services. Furthermore, going forward, the functional reporting 
data we would collect may be even less useful for purposes of 
recommending or reforming payment for therapy services because, as 
described earlier, section 50202 of the

[[Page 35853]]

Bipartisan Budget Act of 2018 (BBA of 2018) amended section 1833(g) of 
the Act to repeal the application of the Medicare outpatient therapy 
caps and associated exceptions process, while imposing protections to 
ensure therapy services are furnished when appropriate.
    The general consensus of the commenters (organizations of physical 
therapists, occupational therapists, and speech-language pathologists, 
as well as other organizations of providers of therapy services and 
individual stakeholders) who responded to our RFI on burden reduction 
was that the functional reporting requirements for outpatient therapy 
services are overly complex and burdensome. The majority of commenters 
urged us to substantially revise and repurpose our functional reporting 
requirements for other programmatic purposes or to eliminate the 
functional reporting requirements all together. Most commenters to the 
RFI on burden reduction criticized us for not having shared with them 
an analysis of the functional reporting data we had collected to date, 
even though MCTRJCA does not require that we share any such analysis. A 
couple of commenters recommended we evolve our functional reporting 
requirements, at least in the short-term, with the following three 
changes: (a) Require reporting only at intake and discharge; (b) permit 
reporting through clinical data registries, electronic health records 
(EHRs), facility-based submission vehicles, etc., instead of the 
claims-based reporting required by section 3005(g) of MCTRJCA; and (c) 
allow functional reporting by therapy providers under MIPS as a 
clinical practice improvement activity. The short-term recommendation 
for reduced reporting was based on an independent analysis by one 
specialty society using a sample of our CY 2014 claims. That analysis 
noted that over an episode of care: (a) 93 percent reported when an 
evaluation code was reported; (b) 12 percent to 16 percent reported at 
the time of progress reporting interval; and (c) 36 percent of the 
episodes reported discharge data. In the long-term, these same RFI 
commenters believe our functional reporting system should be eliminated 
in favor of CMS policies that move therapy providers toward reporting 
using standardized measures of function. Other commenters suggested 
that we use standardized measures that reflect global function, or that 
are condition-specific. Some commenters would like to see CMS develop 
setting-appropriate quality measures for outpatient therapy that can be 
used to both (a) measure functionality and (b) meld patient assessment 
data and functional measures with relevant measures developed in 
response to the Improving Medicare Post-Acute Care Transformation Act 
of 2014 (IMPACT Act of 2014) (Pub. L. 113-185) that is applicable to 
CMS post-acute care (PAC) settings.
    As part of the requirements of section 3005(g) of MCTRJCA, we 
established our functional reporting claims-based data collection 
strategy effective January 1, 2013 in the CY 2013 PFS final rule (77 FR 
689580 through 68978) and will have been collecting these functional 
reporting data for the last 5 years at the close of CY 2018. Because 
the data from the functional reporting system were to be used to inform 
our recommendations and reform of Medicare payment for outpatient 
therapy services that are subject to the therapy caps under section 
1833(g) of the Act, we reviewed and analyzed the data internally but 
did not find them particularly useful in considering how to reform 
payment for therapy services as an alternative to the therapy caps. In 
the meantime, section 50202 of BBA of 2018, as discussed previously, 
amended section 1833(g) of the Act to reform therapy payment. Because 
section 3005(g) of MCTRJCA was not codified into the Act, and did not 
specify how long the data collection strategy should last, we do not 
believe it was intended to last indefinitely. We note that we share 
commenters' concerns, including those who favor the elimination of 
functional reporting because it is overly complex and burdensome to 
report, and that those that questioned the utility of the collected 
data given the lack of standardized measures used to report the 
severity of the functional limitation being reported. In response to 
commenters' concerns that we have not yet shared an analysis of the 
collected functional reporting data with them, we note that we have not 
published or shared the results to date because we did not find the 
results informative when reviewing them for purpose of the section 
3005(g) of MCTRJCA requirement. A few commenters requested that we 
continue to collect functional reporting data in a reduced format--at 
the outset and at discharge of the therapy episode--as a collective 
short-term solution, while favoring the elimination of functional 
reporting in the long-term because, according to our data and the 
commenters' own data, the discharge data are only infrequently 
reported. However, we do not believe that collecting additional years 
of functional reporting data in this reduced format would add utility 
to our data collection efforts. After consideration of these comments 
on the RFI along with a review of all of the requirements under section 
3005(g) of MCTRJCA, and in light of the recent statutory amendments to 
section 1833(g) of the Act, we have concluded that continuing to 
collect more years of these functional reporting data, whether through 
the same or a reduced format, will not yield additional information 
that would be useful to inform future analyses, and that allowing the 
current functional reporting requirements to remain in place could 
result in unnecessary burden for providers of therapy services without 
providing further benefit to the Medicare program in the form of 
additional data.
    As a result, we are proposing to discontinue the functional 
reporting requirements for services furnished on or after January 1, 
2019. Specifically, we are proposing to amend our regulations by 
removing the following: (1) Conditions of payment at Sec. Sec.  
410.59(a)(4), 410.60(a)(4), 410.62(a)(4), and 410.105(d) that require 
claims for OT, PT, SLP, and Comprehensive Outpatient Rehabilitation 
Facility (CORF) PT, OT, and SLP services, respectively, to contain 
prescribed information on patient functional limitations; and, (2) the 
functional reporting-related phrase that requires the plan's goals to 
be consistent with functional information on the claim at Sec.  
410.61(c) for outpatient PT, OT, and SLP services and at Sec.  
410.105(c)(1)(ii) for the PT, OT, and SLP services in CORFs. In 
addition, we would: (1) Remove the functional reporting subregulatory 
requirements implemented primarily through Change Request 8005 last 
issued on December 21, 2012, via Transmittal 2622; (2) eliminate the 
functional reporting standard systems edits we have applied to claims; 
and (3) remove the functional reporting requirement provisions in our 
internet Only Manual (IOM) provisions including the Medicare Claims 
Processing Manual, Chapter 5; and, the functional reporting 
requirements in Chapters 12 and 15 of the Medicare Benefits Policy 
Manual.
    If finalized, our proposal would end the requirements for the 
reporting and documentation of functional limitation G-codes (HCPCS 
codes G8978 through G8999 and G9158 through G9186) and severity 
modifiers (in the range CH through CN) for outpatient therapy claims 
with dates of service on and after January 1, 2019. Accordingly, with 
the conclusion of our functional reporting system for dates of service 
after

[[Page 35854]]

December 31, 2018, we would delete the applicable non-payable HCPCS G-
codes specifically developed to implement that system through the CY 
2013 PFS final rule with comment period (77 FR 68598 through 68978).
    We are seeking comment on these proposals.

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

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

[[Page 35855]]

2019, WAC based payments for Part B drugs made under section 
1847A(c)(4) of the Act, utilize a 3 percent add-on in place of the 6 
percent add-on that is currently being used. We are proposing a 3 
percent add-on because this percentage is consistent with MedPAC's 
analysis and recommendations discussed in the paragraph above and cited 
in their June 2017 Report to the Congress. Although other approaches 
for modifying the add-on amount, such as a flat fee, or percentages 
that vary with the cost of a drug, are possible, we are proposing a 
fixed percentage in order to be consistent with other provisions in 
section 1847A of the Act which specify fixed add-on percentages of 6 
percent (1847A(b)) or 3 percent (section 1847A(d)(3)(C) of the Act). A 
fixed percentage is also administratively simple to implement and 
administer, is predictable, and is easy for manufacturers, providers 
and the public to understand.
    We have also reviewed corresponding regulation text at Sec.  
414.904(e)(4). To conform the regulation text more closely to the 
statutory language at section 1847A(c)(4) of the Act, we are also 
proposing to strike the word ``applicable'' from paragraph (e)(4). 
Section 1847A(c)(4) of the Act does not use the term ``applicable'' to 
describe the payment methodologies in effect on November 1, 2003.
    If we were to finalize these proposals, we would also change the 
policy articulated in the Claims Processing Manual that describes the 
application of the 6 percent add-on to payment determinations made by 
MACs for new drugs and biologicals. Chapter 17 section 20.1.3 of the 
Claims Processing Manual (https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c17.pdf) states that WAC-based payment 
limits for drugs and biologicals that are produced or distributed under 
a new drug application (or other new application) approved by the Food 
and Drug Administration, and that are not included in the ASP Medicare 
Part B Drug Pricing File or Not Otherwise Classified (NOC) Pricing 
File, are based on 106 percent of WAC. Invoice-based pricing is used if 
the WAC is not published. In OPPS, the payment allowance limit is 95 
percent of the published Average Wholesale Price (AWP). We would change 
our policy to permit MACs to use an add-on percentage of up to 3 
percent for WAC-based payments for new drugs. MACs have longstanding 
authority to make payment determinations when we do not publish a 
payment limit in our national Part B drug pricing files and when new a 
drug becomes available. This proposal would preserve consistency with 
our proposed national pricing policy and would apply when MACs perform 
pricing determinations, for example during the period when ASPs have 
not been reported. This proposed policy would not alter OPPS payment 
limits.
    We note that these proposals do not include WAC-based payments for 
single source drugs under section 1847A(b) of the Act, that is, where 
the statute specifies that the payment limit is 106 percent of the 
lesser of ASP or WAC.
    We have stated in previous rulemaking that it is desirable to have 
fair reimbursement in a healthy marketplace that encourages product 
development (80 FR 71101). We have also stated that we seek to promote 
innovation to provide more options to patients and physicians, and 
competition to drive prices down (82 FR 53183). These positions have 
not changed. However, since 2011, concern about the impact of drug 
pricing and spending on Part B drugs has continued to grow. From 2011 
to 2016, Medicare Part B drug spending increased from $17.6 billion to 
$28.0 billion, representing a compound annual growth rate of 9.8 
percent, with per capita spending increasing 54 percent, from $532 to 
$818 (Based on Spending and Enrollment Data from Centers for Medicare 
and Medicaid Services Office of Enterprise Data and Analytics). These 
increases affect the spending by Medicare and beneficiary out-of-pocket 
costs. In the context of these concerns, we believe that implementation 
of these proposals will improve Medicare payment rates by better 
aligning payments with drug acquisition costs, especially for the 
growing number of drugs with high annual spending and high launch 
prices where single doses can cost tens or even hundreds of thousands 
of dollars. The proposals will also decrease beneficiary cost sharing. 
A 3 percentage point reduction in the total payment allowance will 
reduce a patient's 20 percent Medicare Part B copayment--for a drug 
that costs many thousands of dollars per dose, this can result in 
significant savings to an individual. The proposed approach would help 
Medicare beneficiaries afford to pay for new drugs by reducing out of 
pocket expenses and would help counteract the effects of increasing 
launch prices for newly approved drugs and biologicals. Finally, the 
proposals are consistent with recent MedPAC recommendations.

III. Other Provisions of the Proposed Rule

A. Clinical Laboratory Fee Schedule

1. Background
    Prior to January 1, 2018, Medicare paid for clinical diagnostic 
laboratory tests (CDLTs) on the Clinical Laboratory Fee Schedule (CLFS) 
under sections 1832, 1833(a), (b) and (h), and 1861 of the Social 
Security Act (the Act). Under the previous methodology, CDLTs were paid 
based on the lesser of: (1) The amount billed; (2) the local fee 
schedule amount established by the Medicare Administrative Contractor 
(MAC); or (3) a national limitation amount (NLA), which is a percentage 
of the median of all the local fee schedule amounts (or 100 percent of 
the median for new tests furnished on or after January 1, 2001). In 
practice, most tests were paid at the NLA. Under the previous system, 
the CLFS amounts were updated for inflation based on the percentage 
change in the Consumer Price Index for All Urban Consumers (CPI-U), and 
reduced by a multi-factor productivity adjustment and other statutory 
adjustments, but were not otherwise updated or changed.
    Section 1834A of the Act, as established by section 216(a) of the 
Protecting Access to Medicare Act of 2014 (PAMA), required significant 
changes to how Medicare pays for CDLTs under the CLFS. The CLFS final 
rule, entitled Medicare Clinical Diagnostic Laboratory Tests Payment 
System (CLFS final rule), published in the Federal Register on June 23, 
2016, implemented section 1834A of the Act. Under the CLFS final rule, 
``reporting entities'' must report to CMS during a ``data reporting 
period'' ``applicable information'' collected during a ``data 
collection period'' for their component ``applicable laboratories.'' 
Applicable information is defined at Sec.  414.402 as, with respect to 
each CDLT for a data collection period: Each private payor rate for 
which final payment has been made during the data collection period; 
the associated volume of tests performed corresponding to each private 
payor rate; and the specific Healthcare Common Procedure Coding System 
(HCPCS) code associated with the test. Applicable information does not 
include information about a test for which payment is made on a 
capitated basis. An applicable laboratory is defined at Sec.  414.502, 
in part, as an entity that is a laboratory (as defined under the 
Clinical Laboratory Improvement Amendments (CLIA) definition at Sec.  
493.2) that bills Medicare Part B under its own National Provider 
Identifier

[[Page 35856]]

(NPI). In addition, an applicable laboratory is an entity that receives 
more than 50 percent of its Medicare revenues during a data collection 
period from the CLFS and/or the Physician Fee Schedule (PFS). We refer 
to this component of the applicable laboratory definition as the 
``majority of Medicare revenues threshold.'' The definition of 
applicable laboratory also includes a ``low expenditure threshold'' 
component which requires an entity to receive at least $12,500 of its 
Medicare revenues from the CLFS for its CDLTs that are not advanced 
diagnostic laboratory tests (ADLTs).
    The first data collection period, for which applicable information 
was collected, occurred from January 1, 2016 through June 30, 2016. The 
first data reporting period, during which reporting entities reported 
applicable information to CMS, occurred January 1, 2017 through March 
31, 2017. On March 30, 2017, we announced a 60-day enforcement 
discretion period of the assessment of Civil Monetary Penalties (CMPs) 
for reporting entities that failed to report applicable information. 
Additional information about the 60-day enforcement discretion period 
may be found on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Downloads/2017-March-Announcement.pdf.
    In general, the payment amount for each CDLT on the CLFS furnished 
beginning January 1, 2018, is based on the applicable information 
collected during the data collection period and reported to us during 
the data reporting period, and is equal to the weighted median of the 
private payor rates for the test. The weighted median is calculated by 
arraying the distribution of all private payor rates, weighted by the 
volume for each payor and each laboratory. The payment amounts 
established under the CLFS are not subject to any other adjustment, 
such as geographic, budget neutrality, or annual update, as required by 
section 1834A(b)(4)(B) of the Act. Additionally, section 1834A(b)(3) of 
the Act, implemented at Sec.  414.507(d), provides a phase-in of 
payment reductions, limiting the amounts the CLFS rates for each CDLT 
(that is not a new ADLT or new CDLT) can be reduced as compared to the 
payment rates for the preceding year. For the first 3 years after 
implementation (CY 2018 through CY 2020), the reduction cannot be more 
than 10 percent per year, and for the next 3 years (CY 2021 through CY 
2023), the reduction cannot be more than 15 percent per year. For most 
CDLTs, the data collection period, data reporting period, and payment 
rate update occur every 3 years. As such, the next data collection 
period for most CDLTs will be January 1, 2019 through June 30, 2019, 
and the next data reporting period will be January 1, 2020 through 
March 31, 2020, with the next update to CLFS occurring on January 1, 
2021. Additional information on the private payor rate-based CLFS is 
detailed in the CLFS final rule (81 FR 41036 through 41101).
2. Recent Stakeholder Feedback
    After the initial data collection and data reporting periods, we 
received stakeholder feedback on a range of topics related to the 
private payor rate-based CLFS. Some stakeholders expressed concern that 
the CY 2018 CLFS payments rates are based on applicable information 
from only a relatively small number of laboratories. Some stakeholders 
stated that, because most hospital-based laboratories were not 
applicable laboratories, and therefore, did not report applicable 
information during the initial data reporting period, the CY 2018 CLFS 
payment rates do not reflect their information and are inaccurate. 
Other stakeholders were concerned that the low expenditure threshold 
excluded most physician office laboratories and many small independent 
laboratories from reporting applicable information.
    In determining payment rates under the private payor rate-based 
CLFS, one of our objectives is to obtain as much applicable information 
as possible from the broadest possible representation of the national 
laboratory market on which to base CLFS payment amounts, for example, 
from independent laboratories, hospital outreach laboratories, and 
physician office laboratories, without imposing undue burden on those 
entities. As we noted throughout the CLFS final rule, we believe it is 
important to achieve a balance between collecting sufficient data to 
calculate a weighted median that appropriately reflects the private 
market rate for a CDLT, and minimizing the reporting burden for 
entities. In response to stakeholder feedback and in the interest of 
facilitating our goal, we are proposing one change, discussed below, to 
the Medicare CLFS for CY 2019. We believe this proposal may result in 
more data being used on which to base CLFS payment rates.
    In addition to this proposal, we are soliciting public comments on 
other approaches that have been requested by some stakeholders who 
suggested that such approaches would result in CMS receiving even more 
applicable information to use in establishing CLFS payment rates. The 
approaches include revising the definition of applicable laboratory and 
changing the low expenditure threshold. These topics are discussed 
below.
3. Proposed Change to the Majority of Medicare Revenues Threshold in 
Definition of Applicable Laboratory
    In order for a laboratory to meet the majority of Medicare revenues 
threshold, section 1834A(a)(2) of the Act requires that, ``with respect 
to its revenues under this title, a majority of such revenues are 
from'' the CLFS and the PFS in a data collection period. In the CLFS 
final rule, we stated that ``revenues under this title'' are payments 
received from the Medicare program, which includes fee-for-service 
payments under Medicare Parts A and B, as well as Medicare Advantage 
(MA) payments under Medicare Part C, and prescription drug payments 
under Medicare Part D, and any associated Medicare beneficiary 
deductible or coinsurance amounts for Medicare services furnished 
during the data collection period (81 FR 41043). This total Medicare 
revenues amount (the denominator in the majority of Medicare revenues 
threshold calculation) is compared to the total of Medicare revenues 
received from the CLFS and/or PFS (the numerator in the majority of 
Medicare revenues threshold calculation). If the numerator is greater 
than 50 percent of the denominator for a data collection period, the 
entity has met the majority of Medicare revenues threshold criterion. 
We reflected that requirement in Sec.  414.502 in the third paragraph 
of the definition of applicable laboratory.
    We have considered that our current interpretation of total 
Medicare revenues may have the effect of excluding laboratories that 
furnish Medicare services to a significant number of beneficiaries 
enrolled in MA plans under Medicare Part C from meeting the majority of 
Medicare revenues threshold criterion, and therefore, from qualifying 
as applicable laboratories. For instance, if a laboratory has a 
significant enough Part C component so that it is receiving greater 
than 50 percent of its total Medicare revenues from MA payments under 
Part C, it would not meet the majority of Medicare revenues threshold 
because its revenues derived from the CLFS and/or PFS would not 
constitute a majority of its total Medicare revenues. We believe that 
if we were to exclude MA plan revenues from total Medicare revenues, 
more laboratories of all types may meet the majority of Medicare 
revenues threshold, and therefore, the definition

[[Page 35857]]

of applicable laboratory, because it would have the effect of 
decreasing the amount of total Medicare revenues and increase the 
likelihood that a laboratory's CLFS and PFS revenues would constitute a 
majority of its Medicare revenues.
    We believe section 1834A of the Act permits an interpretation that 
MA plan payments to laboratories not be included in the total Medicare 
revenues component of the majority of Medicare revenues threshold 
calculation. Rather, MA plan payments to laboratories can be considered 
to only be private payor payments under the CLFS. We emphasize here 
that this characterization of MA plan payments is limited to only the 
CLFS for purposes of defining applicable laboratory. Whether MA plan 
payments to laboratories or other entities are considered Medicare 
``revenues'' or ``private payor payments'' in other contexts in the 
Medicare program is irrelevant here. Nor does our characterization of 
MA plan payments as private payor payments for purposes of the CLFS 
have any bearing on any aspect of the Medicare program other than the 
CLFS. This is because of language included in section 1834A of the Act 
that is specifically targeted to the CLFS, explained below.
    As noted above, we defined total Medicare revenues for purposes of 
the majority of Medicare revenues threshold calculation to include fee-
for-service payments under Medicare Parts A and B, as well as MA 
payments under Medicare Part C, and prescription drug payments under 
Medicare Part D, and any associated Medicare beneficiary deductible or 
coinsurance amounts for Medicare services furnished during the data 
collection period. However, section 1834A(a)(8) of the Act, which 
defines the term ``private payor,'' identifies at section 
1834A(a)(8)(B) a ``Medicare Advantage plan under Part C'' as a type of 
private payor. Under the private payor rate-based CLFS, CLFS payment 
amounts are based on private payor rates that are reported to CMS. So, 
an applicable laboratory that receives Medicare Advantage (MA) plan 
payments is to consider those MA plan payments in identifying its 
applicable information, which must be reported to CMS. We believe it is 
more logical to not consider MA plan payments under Part C to be both 
Medicare revenues for determining applicable laboratory status and 
private payor rates for purposes of reporting applicable information. 
Congress contemplated that applicable laboratories would furnish MA 
services, as reflected in the requirement that private payor rates must 
be reported for MA services. However, under our current definition of 
applicable laboratory, laboratories that furnish MA services, 
particularly those that furnish a significant amount, are less likely 
to meet the majority of Medicare revenues threshold, which means they 
would be less likely to qualify as applicable laboratories, and 
therefore, to report private payor rates for MA services.
    Therefore, after further review and consideration of the new 
private payor rate-based CLFS, we believe it is appropriate to include 
MA plan revenues as only private payor payments rather than both 
Medicare revenues, for the purpose of determining applicable laboratory 
status, and private payor payments, for the purpose of specifying what 
is applicable information. Such a change would have the effect of 
eliminating the laboratory revenue generated from a laboratory's Part 
C-enrolled patient population as a factor in determining whether a 
majority of the laboratory's Medicare revenues are comprised of 
services paid under the CLFS or PFS. We believe this change would 
permit a laboratory with a significant Medicare Part C revenue 
component to be more likely to meet the majority of Medicare revenues 
threshold and qualify as an applicable laboratory. In other words, MA 
payments are currently included as total Medicare revenues (the 
denominator). In order to meet the majority of Medicare revenues 
threshold, the statute requires a laboratory to receive the majority of 
its Medicare revenues from the CLFS and or PFS. If MA plan payments 
were excluded from the total Medicare revenues calculation, the 
denominator amount would decrease. If the denominator amount decreases, 
the likelihood increases that a laboratory would qualify as an 
applicable laboratory. Therefore, we believe this proposal responds 
directly to stakeholders' concerns regarding the number of laboratories 
for which applicable information must be reported because a broader 
representation of the laboratory industry may qualify as applicable 
laboratories, which means we would receive more applicable information 
to use in setting CLFS payment rates.
    For these reasons, we are proposing that MA plan payments under 
Part C would not be considered Medicare revenues for purposes of the 
applicable laboratory definition. We would revise paragraph (3) of the 
definition of applicable laboratory at Sec.  414.502 accordingly. We 
reiterate that not characterizing MA plan payments under Medicare Part 
C as Medicare revenues would be limited to the definition of applicable 
laboratory under the CLFS, and would not affect, reflect on, or 
otherwise have any bearing on any other aspect of the Medicare program.
    In an effort to provide stakeholders a better understanding of the 
potential reporting burden that may result from this proposal, we are 
providing a summary of the distribution of data reporting that occurred 
for the first data reporting period. If we were to finalize the 
proposed change to the majority of Medicare revenues threshold 
component of the definition of applicable laboratory, additional 
laboratories of all types serving a significant population of 
beneficiaries enrolled in Medicare Part C could potentially qualify as 
applicable laboratories, in which case their data would be reported to 
us. As discussed previously, we received over 4.9 million records from 
1,942 applicable laboratories for the initial data reporting period, 
which we used to set CY 2018 CLFS rates. Additional analysis shows that 
the average number of records reported for an applicable laboratory was 
2,573. The largest number of records reported for an applicable 
laboratory was 457,585 while the smallest amount was 1 record. A 
summary of the distribution of reported records from the first data 
collection period is illustrated in the Table 24.

                                          Table 24--Summary of Records Reported for First Data Reporting Period
                                                               [By applicable laboratory]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                     Percentile distribution of records
              Total records                  Average     Min records   Max records ---------------------------------------------------------------------
                                             records                                    10th          25th          50th          75th          90th
--------------------------------------------------------------------------------------------------------------------------------------------------------
4,995,877...............................        2,573             1       457,585            23            79           294         1,345         4,884
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 35858]]

    Assuming a similar distribution of data reporting for the next data 
reporting period, the mid-point of reported records for an applicable 
laboratory would be approximately 300 (50th percentile for the first 
data reporting period was 294). However, as illustrated in Table 24, 
the number of records reported varies greatly, depending on the volume 
of services performed by a given laboratory. Laboratories with larger 
test volumes, for instance at the 90th percentile, should expect to 
report more records as compared to the midpoint used for this analysis. 
Likewise, laboratories with smaller test volume, for instance at the 
10th percentile, should expect to report less records as compared to 
the midpoint.
    We welcome comments on our proposal to modify the definition of 
applicable laboratory to exclude MA plan payments under Part C as 
Medicare revenues.
4. Solicitation of Public Comments on Other Approaches to Defining 
Applicable Laboratory
    As noted previously, we define applicable laboratory at the NPI 
level, which means the laboratory's own billing NPI is used to identify 
a laboratory's revenues for purposes of determining whether it meets 
the majority of Medicare revenues threshold and the low expenditure 
threshold components of the applicable laboratory definition. For 
background purposes, the following summarizes some of the 
considerations we made in establishing this policy.
    In the CLFS proposed rule, entitled Medicare Clinical Diagnostic 
Laboratory Tests Payment System, published in the October 1, 2015 
Federal Register, we proposed to define applicable laboratory at the 
TIN level so that an applicable laboratory would be an entity that 
reports tax-related information to the IRS under a TIN with which all 
of the NPIs in the entity are associated, and was itself a laboratory 
or had at least one component that was a laboratory, as defined in 
Sec.  493.2. In the CLFS proposed rule, we discussed that we considered 
proposing to define applicable laboratory at the NPI level. However, we 
did not propose that approach because we believed private payor rates 
for CDLTs are negotiated at the TIN level and not by individual 
laboratory locations at the NPI level. Numerous stakeholders had 
indicated that the TIN-level entity is the entity negotiating pricing, 
and therefore, is the entity in the best position to compile and report 
applicable information across its multiple NPIs when there are multiple 
NPIs associated with a TIN-level entity. We stated that we believed 
defining applicable laboratory by TIN rather than NPI would result in 
the same applicable information being reported, and would require 
reporting by fewer entities, and therefore, would be less burdensome to 
applicable laboratories. In addition, we stated that we did not believe 
reporting at the TIN level would affect or diminish the quality of the 
applicable information reported. To the extent the information is 
accurately reported, we expected reporting at a higher organizational 
level to produce exactly the same applicable information as reporting 
at a lower level (80 FR 59391 through 59393).
    Commenters who objected to our proposal to define applicable 
laboratory at the TIN level stated that our definition would exclude 
hospital laboratories because, in calculating the applicable 
laboratory's majority of Medicare revenues amount, which looks at the 
percentage of Medicare revenues from the PFS and CLFS across the entire 
TIN-level entity, virtually all hospital laboratories would not be 
considered an applicable laboratory. Many commenters expressed 
particular concern that our proposed definition would exclude hospital 
outreach laboratories, stating that hospital outreach laboratories, 
which do not provide laboratory services to hospital patients, are 
direct competitors of the broader independent laboratory market, and 
therefore, excluding them from the definition of applicable laboratory 
would result in incomplete and inappropriate applicable information, 
which would skew CLFS payment rates. Commenters maintained that CMS 
needed to ensure reporting by a broad scope of the laboratory market to 
meet what they viewed as Congressional intent that all sectors of the 
laboratory market be included to establish accurate market-based rates 
(81 FR 41045).
    In issuing the CLFS final rule, we found particularly compelling 
the comments that urged us to adopt a policy that would better enable 
hospital outreach laboratories to be applicable laboratories because we 
agreed hospital outreach laboratories should be accounted for in the 
new CLFS payment rates. We noted that hospital outreach laboratories 
are laboratories that furnish laboratory tests for patients who are not 
admitted hospital inpatients or registered outpatients of the hospital 
and who are enrolled in Medicare separately from the hospital of which 
they are a part as independent laboratories that do not serve hospital 
patients. We believed it was important to facilitate reporting of 
private payor rates for hospital outreach laboratories to ensure a 
broader representation of the national laboratory market to use in 
setting CLFS payment amounts (81 FR 41045).
    We were clear in the CLFS final rule, however, that we believe 
Congressional intent was to effectively exclude hospital laboratories 
as applicable laboratories, which was apparent from the statutory 
language, in particular, the majority of Medicare revenues threshold 
criterion in section 1834A(a)(2) of the Act. Section 1834A(a)(2) of the 
Act provides that, to qualify as an applicable laboratory, an entity's 
revenues from the CLFS and the PFS needs to constitute a majority of 
its total Medicare payments received from the Medicare program for a 
data collection period. What we found significant was that most 
hospital laboratories would not meet that majority of Medicare revenues 
threshold because their revenues under the IPPS and OPPS alone would 
likely far exceed the revenues they received under the CLFS and PFS. 
Therefore, we believe the statute intended to limit reporting primarily 
to independent laboratories and physician offices (81 FR 41045 through 
41047). For a more complete discussion of the definition of applicable 
laboratory, see the CLFS final rule (81 FR 41041 through 41051).
a. Stakeholder Continuing Comments and Stakeholder-Suggested 
Alternative Approaches
    As noted above, in response to public comments, we finalized that 
an applicable laboratory is the NPI-level entity so that a hospital 
outreach laboratory assigned a unique NPI, separate from the hospital 
of which it is a part, is able to meet the definition of applicable 
laboratory and its applicable information can be used for CLFS rate-
setting. We continue to believe that the NPI is the most effective 
mechanism for identifying Medicare revenues for purposes of determining 
applicable laboratory status and identifying private payor rates for 
purposes of reporting applicable information. Once a hospital outreach 
laboratory obtains its own unique billing NPI and bills for services 
using its own unique NPI, Medicare and private payor revenues are 
directly attributable to the hospital outreach laboratory. By defining 
applicable laboratory using the NPI, Medicare payments (for purposes of 
determining applicable laboratory status) and private payor rates and 
the associated volume of CDLTs can be more easily identified and 
reported to us. We also believe that, if finalized, our proposal to 
exclude MA plan revenues under Medicare Part C from total Medicare 
revenues in the

[[Page 35859]]

definition of applicable laboratory may increase the number of entities 
meeting the majority of Medicare revenues threshold, and therefore, 
qualifying for applicable laboratory status. In summary, we believe the 
proposed change to the total Medicare revenues component of the 
applicable laboratory definition and our current policy that requires 
an entity to bill Medicare Part B under its own NPI, may increase the 
number of hospital outreach laboratories qualifying as applicable 
laboratories.
    In addition, we are confident that our current policy supports our 
collecting sufficient applicable information in the next data reporting 
period, and that we received sufficient and reliable applicable 
information with which we set CY 2018 CLFS rates, and that those rates 
are accurate. For instance, we received applicable information from 
laboratories in every state, the District of Columbia, and Puerto Rico. 
This data included private payor rates for almost 248 million 
laboratory tests conducted by 1,942 applicable laboratories, with over 
4 million records of applicable information. In addition, as we've 
noted, the largest laboratories dominate the market, and therefore, 
most significantly affect the payment weights (81 FR 41049). Given that 
the largest laboratories reported their applicable information to CMS 
in the initial data reporting period, along with many smaller 
laboratories, we believe the data we used to calculate the CY 2018 CLFS 
rates was sufficient and resulted in accurate weighted medians of 
private payor rates.
    However, we continue to consider refinements to our policies that 
could lead to including even more applicable information for the next 
data reporting period. To that end, the comments and alternative 
approaches suggested by stakeholders, even though some were first 
raised prior to the CLFS final rule, are presented and considered for 
comment now.
(1) Using Form CMS-1450 Bill Type 14x To Determine Majority of Medicare 
Revenues and Low Expenditure Thresholds
    Some stakeholders that expressed concern over the CY 2018 CLFS 
payments rates stated that the NPI-based definition of applicable 
laboratory reduces the number of hospital outreach laboratories 
reporting data. These stakeholders suggested we revise the definition 
specifically for the purpose of including more hospital outreach 
laboratories. Under a suggested approach, a laboratory could determine 
whether it meets the majority of Medicare revenues threshold and low 
expenditure threshold using only the revenues from services reported on 
the Form CMS-1450 (approved Office of Management and Budget number 
0938-0997) 14x bill type, which is used only by hospital outreach 
laboratories. Therefore, per the stakeholder suggestions, we are 
seeking public comments on the following approach.
    This approach would revise the definition of applicable laboratory 
to permit the revenues identified on the Form CMS-1450 14x bill type to 
be used instead of the revenues associated with the NPI the laboratory 
uses, to determine whether it meets the majority of Medicare revenues 
threshold (and the low expenditure threshold). Under this approach, the 
applicable revenues would be based on the bills used for hospital 
laboratory services provided to non-patients, which are paid under 
Medicare Part B (that is, the 14x bill type). If we pursued this 
approach, we would have to modify the definition of applicable 
laboratory in Sec.  414.502 by indicating that an applicable laboratory 
may include an entity that bills Medicare Part B on the Form CMS-1450 
14x bill type.
    Although using the 14x bill type could alleviate some initial, 
albeit limited, administrative burden on hospital outreach laboratories 
to obtain a unique billing NPI, we would have operational and statutory 
authority concerns about defining applicable laboratory by the Form 
CMS-1450 14x bill type.
    First, defining applicable laboratory using the Form CMS-1450 14x 
bill type does not identify an entity the way an NPI does. Whereas an 
NPI is associated with a provider or supplier to determine specific 
Medicare revenues, the 14x bill type is merely a billing mechanism that 
is currently used only for a limited set of services. Under an approach 
that permits laboratories to meet the majority of Medicare revenues 
threshold using the 14x bill type, private payor rates (and the volume 
of tests paid at those rates) would have to be identified that are 
associated with only the outreach laboratory services of a hospital's 
laboratory business. However, some private payors, such as MA plans, 
may not require hospital laboratories to use the 14x bill type for 
their outreach laboratory services. To the extent a private payor does 
not require hospital outreach laboratory services to be billed on a 14x 
bill type (which specifically identifies outreach services), hospitals 
may need to develop their own mechanism for identifying and reporting 
only the applicable information associated with its hospital outreach 
laboratory services. In light of this possible scenario, we are 
interested in public comments about the utility of using the 14x bill 
type in the way we have described and on the level of administrative 
burden created if we defined applicable laboratory using the Form CMS-
1450 14x bill type.
    Second, we question whether hospitals would have sufficient time 
after publication of a new final rule that included using the Form CMS-
1450 14x bill type, and any related subregulatory guidance, to develop 
and implement the information systems necessary to collect private 
payor rate data before the start of the next data collection period, 
that is, January 1, 2019. To that end, we are interested in public 
comments as to whether revising the definition of applicable laboratory 
to use the Form CMS-1450 14x bill type would allow laboratories 
sufficient time to make the necessary systems changes to identify 
applicable information before the start of the next data collection 
period.
    Third, we believe defining applicable laboratory at the NPI level, 
as we currently do, provides flexibility for hospital outreach 
laboratories to not obtain a unique billing NPI, which may be 
significant particularly where a hospital outreach laboratory performs 
relatively few outreach services under Medicare Part B. For example, 
under the current definition of applicable laboratory, if a hospital 
outreach laboratory's CLFS revenues in a data collection period are 
typically much less than the low expenditure threshold, the hospital of 
which it is a part could choose not to obtain a separate NPI for its 
outreach laboratory and could thus avoid determining applicable 
laboratory status for its outreach laboratory component. In contrast, 
if laboratories were permitted to use the Form CMS-1450 14x bill type, 
revenues attributed to the hospital outreach laboratory would have to 
be calculated in every instance where those services exceeded the low 
expenditure threshold. This would be true even for a hospital outreach 
laboratory that performs relatively few outreach services under 
Medicare Part B. Therefore, we are interested in comments concerning 
this aspect of using the 14x bill type definition.
    Fourth, and significantly, we believe that if we were to utilize 
such an approach in defining applicable laboratory, all hospital 
outreach laboratories would meet the majority of Medicare revenues 
threshold. At this time, we believe that this approach would be 
inconsistent with the statute. By virtue of the majority of Medicare 
revenues threshold, the statute defines applicable laboratory in such a 
way that

[[Page 35860]]

not all laboratories qualify as applicable laboratories. However, if we 
were to use the CMS-1450 14x bill type to define an applicable 
laboratory, all hospital outreach laboratories that use the 14x bill 
type would meet the majority of Medicare revenues threshold. 
Accordingly, we are interested in public comments regarding whether 
this definition would indeed be inconsistent with the statute, as well 
as comments that can identify circumstances under this definition 
whereby a hospital outreach laboratory would not meet the majority of 
Medicare revenues threshold.
(2) Using CLIA Certificate To Define Applicable Laboratories
    Some industry stakeholders have requested that we use the CLIA 
certificate rather than the NPI to identify a laboratory that would be 
considered an applicable laboratory. We discussed in the CLFS proposed 
rule (80 FR 59392) why not all entities that meet the CLIA regulatory 
definition at Sec.  493.2 would be applicable laboratories, and 
therefore, we did not propose to use CLIA as the mechanism for defining 
applicable laboratory. However, some commenters to the CLFS proposed 
rule suggested we use the CLIA certificate to identify the 
organizational entity that would be considered an applicable laboratory 
so that each entity that had a CLIA certificate would be an applicable 
laboratory (81 FR 41045). We considered those comments in the CLFS 
final rule and discussed why we chose not to adopt that approach.
    Among other reasons, we explained in the CLFS final rule that we 
believed a CLIA certificate-based definition of applicable laboratory 
would be overly inclusive by including all hospital laboratories, as 
opposed to just hospital outreach laboratories. In addition, the CLIA 
certificate is used to certify that a laboratory meets applicable 
health and safety regulations in order to furnish laboratory services. 
It is not associated with Medicare billing so, unlike for example, the 
NPI, with which revenues for specific services can easily be 
identified, the CLIA certificate cannot be used to identify revenues 
for specific services. We also indicated that we did not see how a 
hospital would determine whether its laboratories would meet the 
majority of Medicare revenues threshold (and the low expenditure 
threshold) using the CLIA certificate as the basis for defining an 
applicable laboratory. In addition, we stated that, given the 
difficulties many hospitals would likely have in determining whether 
their laboratories are applicable laboratories, we also believed 
hospitals may object to using the CLIA certificate (81 FR 41045).
    However, in light of stakeholders' suggestions to use the CLIA 
certificate to include hospital outreach laboratories in the definition 
of applicable laboratories, we are soliciting public comments on that 
approach. Under such approach, the majority of Medicare revenues 
threshold and low expenditure threshold components of the definition of 
applicable laboratory would be determined at the CLIA certificate level 
instead of the NPI level. If we pursued such approach, we would have to 
modify the definition of applicable laboratory in Sec.  414.502 to 
indicate that an applicable laboratory is one that holds a CLIA 
certificate under Sec.  493.2 of the chapter. We would have concerns, 
however, about defining applicable laboratory by the CLIA certificate.
    First, as we discussed in the CLFS final rule, given that 
information regarding the CLIA certificate is not required on the Form 
CMS-1450 14x bill type, which is the billing form used by hospitals for 
their laboratory outreach services, it is not clear how a hospital 
would identify and distinguish revenues generated by its separately 
CLIA-certified laboratories for their outreach services. We are 
interested in public comments regarding the mechanisms a hospital would 
need to develop to identify revenues if we used the CLIA certificate 
for purposes of determining applicable laboratory status, as well as 
comments about the administrative burden associated with developing 
such mechanisms.
    In addition, we understand there could be a scenario where one CLIA 
certificate is assigned to a hospital's entire laboratory business, 
which would include laboratory tests performed for hospital patients as 
well as non-patients (that is, patients who are not admitted inpatients 
or registered outpatients of the hospital). For example, hospital 
laboratories with an outreach laboratory component would be assigned a 
single CLIA certificate if the hospital outreach laboratory has the 
same mailing address or location as the hospital laboratory. In this 
scenario, the majority of Medicare revenues threshold would be applied 
to the entire hospital laboratory, not just its outreach laboratory 
component. If a single CLIA certificate is assigned to the hospital's 
entire laboratory business, the hospital laboratory would be unlikely 
to meet the majority of Medicare revenues threshold because its 
laboratory revenues under the IPPS and OPPS alone would likely far 
exceed the revenues it receives under the CLFS and PFS. As a result, a 
hospital outreach laboratory that could otherwise meet the definition 
of applicable laboratory, as currently defined at the NPI level, would 
not be an applicable laboratory if we were to require the CLIA 
certificate to define applicable laboratory. Given that this approach 
could have the effect of decreasing as opposed to increasing the number 
of applicable laboratories, we are requesting public comments on this 
potential drawback of defining applicable laboratory at the CLIA 
certificate level.
    We believe that feedback on the topics discussed in this section 
could help inform us regarding potential refinements to the definition 
of applicable laboratory. We welcome comments on these topics from the 
public, including, physicians, laboratories, hospitals, and other 
interested stakeholders. We are especially interested in comments 
regarding the administrative burden of using the Form CMS-1450 14x bill 
type or CLIA certificate to identify applicable information attributed 
only to the hospital outreach laboratory portion of a hospital's total 
laboratory business. Depending on the comments we receive, it is 
possible we would consider approaches described in this section.
    Again, we continue to believe that our current regulatory 
definitions and data collection processes are reasonable pursuant to 
governing law. The above public comments are solicited as part of the 
agency's ongoing engagement with stakeholders to receive the most up-
to-date information and comments from those affected by the CLFS fee 
schedule.
5. Solicitation of Public Comments on the Low Expenditure Threshold in 
the Definition of Applicable Laboratory
a. Decreasing the Low Expenditure Threshold
    In the CLFS final rule, we established a low expenditure threshold 
component in the definition of applicable laboratory at Sec.  414.502, 
which is reflected in paragraph (4). To be an applicable laboratory, at 
least $12,500 of an entity's Medicare revenues in a data collection 
period must be CLFS revenues (with the exception that there is no low 
expenditure threshold for an entity with respect to the ADLTs it 
furnishes). We established $12,500 as the low expenditure threshold 
because we believed it achieved a balance between collecting sufficient 
data to calculate a weighted median that appropriately reflects the 
private market rate for a test, and minimizing the reporting burden for 
laboratories that receive a relatively small amount of revenues under 
the CLFS. We indicated in the CLFS final rule (81 FR 41049) that once 
we

[[Page 35861]]

obtained applicable information under the new payment system, we may 
decide to reevaluate the low expenditure threshold in future years and 
propose a different threshold amount through notice and comment 
rulemaking.
    Recently, we have heard from some laboratory stakeholders that the 
low expenditure threshold excludes most physician office laboratories 
and many small independent laboratories from reporting applicable 
information, and that by excluding so many laboratories, the payment 
rates under the new private payor rate-based CLFS reflect incomplete 
data, and therefore, inaccurate CLFS pricing.
    As noted above, we discussed in the CLFS final rule that we 
believed a $12,500 low expenditure threshold would reduce the reporting 
burden on small laboratories. In the CLFS final rule (81 FR 41051), we 
estimated that 95 percent of physician office laboratories and 55 
percent of independent laboratories would not be required to report 
applicable information under our low expenditure criterion. Although we 
substantially reduced the number of laboratories qualifying as 
applicable laboratories (that is, approximately 5 percent of physician 
office laboratories and approximately 45 percent of independent 
laboratories), we estimated that the percentage of Medicare utilization 
would remain high. That is, approximately 5 percent of physician office 
laboratories would account for approximately 92 percent of CLFS 
spending on physician office laboratories and approximately 45 percent 
of independent laboratories would account for approximately 99 percent 
of CLFS spending on independent laboratories (81 FR 41051).
    It is our understanding that physician offices are generally not 
prepared to identify, collect, and report each unique private payor 
rate from each private payor for each laboratory test code subject to 
the data collection and reporting requirements, and the volume 
associated with each unique private payor rate. As such, we believe 
revising the low expenditure threshold so that more physician office 
laboratories are required to report applicable information would likely 
impose significant administrative burdens on physician offices. We also 
believe that increasing participation from physician office 
laboratories would have minimal overall impact on payment rates given 
that the weighted median of private payor rates is dominated by the 
laboratories with the largest test volume. We note that our 
participation simulations from the first data reporting period show 
that increasing the volume of physician office laboratories reporting 
applicable information has minimal overall impact on the weighted 
median of private payor rates. For more information on our 
participation simulations, please visit the CLFS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Downloads/CY2018-CLFS-Payment-System-Summary-Data.pdf.
    We continue to believe the current low expenditure threshold 
strikes an appropriate balance between collecting enough private payor 
rate data to accurately represent the weighted median of private payor 
rates while limiting the administrative burden on small laboratories. 
In addition, as discussed previously in this section, we are proposing 
to exclude MA plan revenues under Part C from total Medicare revenues 
in the definition of applicable laboratory, and if we finalize that 
proposal, we expect more laboratories of all types, including physician 
office laboratories, may meet the majority of Medicare revenues 
threshold.
    However, we recognize from stakeholders that some physician office 
laboratories and small independent laboratories that are not applicable 
laboratories because they do not meet the current low expenditure 
threshold may still want to report applicable information despite the 
administrative burden associated with qualifying as an applicable 
laboratory. Therefore, we are seeking public comments on revising the 
low expenditure threshold to increase the level of participation among 
physician office laboratories and small independent laboratories. One 
approach could be for us to decrease the low expenditure threshold by 
50 percent, from $12,500 to $6,250, in CLFS revenues during a data 
collection period. Under such approach, a laboratory would need to 
receive at least $6,250 in CLFS revenues in a data collection period. 
If we were to adopt such an approach, we would need to revise paragraph 
(4) of the definition of applicable laboratory at Sec.  414.502 to 
replace $12,500 with $6,250. We are seeking public comments on this 
approach.
    We are particularly interested in comments from the physician 
community and small independent laboratories as to the administrative 
burden associated with such a revision to the low expenditure 
threshold. Specifically, we are requesting comments on the following 
issues: (1) Whether physician offices and small independent 
laboratories currently have adequate staff levels to meet the data 
collection and data reporting requirements; (2) whether data systems 
are currently in place to identify, collect, and report each unique 
private payor rate from each private payor for each CLFS test code and 
the volume of tests associated with each unique private payor rate; (3) 
if physician offices and small independent laboratories are generally 
not prepared to conduct the data collection and data reporting 
requirements, what is the anticipated timeframe needed for physician 
office and small independent laboratories to be able to meet the data 
collection and data reporting requirements; and (4) any other 
administrative concerns that decreasing the low expenditure threshold 
may impose on offices and small independent laboratories.
b. Increasing the Low Expenditure Threshold
    We recognize that many small laboratories may not want the 
additional administrative burden of data collection and reporting and, 
because their test volume is relatively low, their data is unlikely to 
have a meaningful impact on the weighted median of private payor rates 
for CDLTs under the CLFS. Mindful of stakeholder feedback from smaller 
laboratories that prefer to not be applicable laboratories because of 
the burden of collecting and reporting applicable information, we could 
increase the low expenditure threshold in the definition of applicable 
laboratory by 50 percent, from $12,500 to $18,750, in CLFS revenues 
during a data collection period. Because physician office laboratories 
would be less likely to meet a higher threshold, such approach would 
decrease the number of physician office laboratories and small 
independent laboratories required to collect and report applicable 
information. We expect decreasing the number of physician office 
laboratories and small independent laboratories reporting applicable 
information will have minimal impact on determining CLFS rates because 
we believe the largest laboratories with the highest test volumes will 
continue to dominate the weighted median of private payor rates.
    If we were to adopt such an approach, we would need to revise 
paragraph (4) of the definition of applicable laboratory at Sec.  
414.502 to replace $12,500 with $18,750. We are seeking public comments 
on this approach. We are particularly interested in comments from the 
physician community and small independent laboratories on the 
administrative burden and relief of increasing the low expenditure

[[Page 35862]]

threshold. We believe that feedback on the topics discussed in this 
section will help inform us regarding potential refinements to the low 
expenditure threshold. We welcome comments on these topics from the 
public including, physicians, laboratories, hospitals, and other 
interested stakeholders. We are particularly interested in receiving 
comments from the physician community and small independent 
laboratories as to the administrative burden and relief associated with 
revisions to the low expenditure threshold. Depending on the comments 
we receive, it is possible we would consider approaches described in 
this section.

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

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

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

     For Air--

++ Fixed Wing Air Ambulance (FW)
++ Rotary Wing Air Ambulance (RW)
b. Statutory Coverage of Ambulance Services
    Under sections 1834(l) and 1861(s)(7) of the Act, Medicare Part B 
(Supplemental Medical Insurance) covers and pays for ambulance 
services, to the extent prescribed in regulations, when the use of 
other methods of transportation would be contraindicated by the 
beneficiary's medical condition.
    The House Ways and Means Committee and Senate Finance Committee 
Reports that accompanied the 1965 Social Security Amendments suggest 
that the Congress intended that--
     The ambulance benefit cover transportation services only 
if other means of transportation are contraindicated by the 
beneficiary's medical condition; and
     Only ambulance service to local facilities be covered 
unless necessary services are not available locally, in which case, 
transportation to the nearest facility furnishing those services is 
covered (H.R. Rep. No. 213, 89th Cong., 1st Sess. 37 and Rep. No. 404, 
89th Cong., 1st Sess. Pt 1, 43 (1965)).
    The reports indicate that transportation may also be provided from 
one hospital to another, to the beneficiary's home, or to an extended 
care facility.
c. Medicare Regulations for Ambulance Services
    The regulations relating to ambulance services are set forth at 42 
CFR part 410, subpart B, and 42 CFR part 414, subpart H. Section 
410.10(i) lists ambulance services as one of the covered medical and 
other health services under Medicare Part B. Therefore, ambulance 
services are subject to basic conditions and limitations set forth at 
Sec.  410.12 and to specific conditions and limitations included at 
Sec. Sec.  410.40 and 410.41. Part 414, subpart H, describes how 
payment is made for ambulance services covered by Medicare Part B.
2. Ambulance Extender Provisions
a. Amendment to Section 1834(l)(13) of the Act
    Section 146(a) of the Medicare Improvements for Patients and 
Providers Act of 2008 (MIPPA), (Pub. L. 110-275) amended section 
1834(l)(13)(A) of the Act to specify that, effective for ground 
ambulance services furnished on or after July 1, 2008, and before 
January 1, 2010, the ambulance fee schedule amounts for ground 
ambulance services shall be increased as follows:
     For covered ground ambulance transports that originate in 
a rural area or in a rural census tract of a metropolitan statistical 
area, the fee schedule amounts shall be increased by 3 percent.
     For covered ground ambulance transports that do not 
originate in a rural area or in a rural census tract of a metropolitan 
statistical area, the fee schedule amounts shall be increased by 2 
percent.
    The payment add-ons under section 1834(l)(13)(A) of the Act have 
been extended several times. Most recently, section 50203(a)(1) of the 
Bipartisan Budget Act of 2018 (BBA) (Pub. L. 115-123, enacted on 
February 9, 2018) amended section 1834(l)(13)(A) of the Act to extend 
the payment add-ons through December 31, 2022. Thus, these payment add-
ons apply to covered ground ambulance transports furnished before 
January 1, 2023. We are proposing to revise Sec.  414.610(c)(1)(ii) to 
conform the regulations to this statutory requirement. (For further 
information regarding the implementation of this provision for claims 
processing, please see CR 10531. For a discussion of past legislation 
extending section 1834(l)(13) of the Act, please see the CY 2014 PFS 
final rule with comment period (78 FR 74438 through 74439), the CY 2015 
PFS final rule with comment period (79 FR 67743) and the CY 2016 PFS 
final rule with comment period (80 FR 71071 through 71072)).
    This statutory requirement is self-implementing. A plain reading of 
the statute requires only a ministerial application of the mandated 
rate increase, and does not require any substantive exercise of 
discretion on the part of the Secretary.
b. Amendment to Section 1834(l)(12) of the Act
    Section 414(c) of the Medicare Prescription Drug, Improvement and 
Modernization Act of 2003 (Pub. L. 108-173, enacted on December 8, 
2003) (MMA) added section 1834(l)(12) to the Act, which specified that, 
in the case of ground ambulance services furnished on or after July 1, 
2004, and before January 1, 2010, for which transportation originates 
in a qualified rural area (as described in the statute), the Secretary 
shall provide for a percent increase in the base rate of the fee 
schedule for such transports. The statute requires this percent 
increase to be based on the Secretary's estimate of the average cost 
per trip for such services (not taking into account mileage) in the 
lowest quartile of all rural county populations as compared to the 
average cost per trip for such services (not taking into account 
mileage) in the highest quartile of rural county populations. Using the 
methodology specified in the July 1, 2004 interim final rule (69 FR 
40288), we determined that this percent increase was equal to 22.6 
percent. As required by the MMA, this payment increase was applied to 
ground ambulance transports that originated in a ``qualified rural 
area,'' that is, to transports that originated in a rural area included 
in those areas comprising the lowest 25th percentile of all rural 
populations arrayed by population density. For this purpose, rural 
areas included Goldsmith areas (a type of

[[Page 35863]]

rural census tract). This rural bonus is sometimes referred to as the 
``Super Rural Bonus'' and the qualified rural areas (also known as 
``super rural'' areas) are identified during the claims adjudicative 
process via the use of a data field included in the CMS-supplied ZIP 
code file.
    The Super Rural Bonus under section 1834(l)(12) of the Act has been 
extended several times. Most recently, section 50203(a)(2) of the BBA 
amended section 1834(l)(12)(A) of the Act to extend this rural bonus 
through December 31, 2022. Therefore, we are continuing to apply the 
22.6 percent rural bonus described in this section (in the same manner 
as in previous years) to ground ambulance services with dates of 
service before January 1, 2023 where transportation originates in a 
qualified rural area. Accordingly, we are proposing to revise Sec.  
414.610(c)(5)(ii) to conform the regulations to this statutory 
requirement. (For further information regarding the implementation of 
this provision for claims processing, please see CR 10531. For a 
discussion of past legislation extending section 1834(l)(12) of the 
Act, please see the CY 2014 PFS final rule with comment period (78 FR 
74439 through 74440), CY 2015 PFS final rule with comment period (79 FR 
67743 through 67744) and the CY 2016 PFS final rule with comment period 
(80 FR 71072)).
    This statutory provision is self-implementing. It requires an 
extension of this rural bonus (which was previously established by the 
Secretary) through December 31, 2022, and does not require any 
substantive exercise of discretion on the part of the Secretary.
3. Amendment to Section 1834(l)(15) of the Act
    Section 637 of the American Taxpayer Relief Act of 2012 (ATRA) 
(Pub.L. 112-240), added section 1834(l)(15) of the Act to specify that 
the fee schedule amount otherwise applicable under the preceding 
provisions of section 1834(l) of the Act shall be reduced by 10 percent 
for ambulance services furnished on or after October 1, 2013, 
consisting of non-emergency basic life support (BLS) services involving 
transport of an individual with end-stage renal disease for renal 
dialysis services (as described in section 1881(b)(14)(B) of the Act) 
furnished other than on an emergency basis by a provider of services or 
a renal dialysis facility. In the CY 2014 PFS final rule with comment 
period (78 FR 74440), we revised Sec.  414.610 by adding paragraph 
(c)(8) to conform the regulations to this statutory requirement.
    Section 53108 of the BBA amended section 1834(l)(15) of the Act to 
increase the reduction from 10 percent to 23 percent effective for 
ambulance services (as described in section 1834(l)(15) of the Act) 
furnished on or after October 1, 2018. The 10 percent reduction applies 
for ambulance services (as described in section 1834(l)(15) of the Act) 
furnished during the period beginning on October 1, 2013 and ending on 
September 30, 2018. Accordingly, we are proposing to revise Sec.  
414.610(c)(8) to conform the regulations to this statutory requirement.
    This statutory requirement is self-implementing. A plain reading of 
the statute requires only a ministerial application of the mandated 
rate decrease, and does not require any substantive exercise of 
discretion on the part of the Secretary. Accordingly, for ambulance 
services described in section 1834(l)(15) of the Act furnished during 
the period beginning on October 1, 2013 and ending on September 30, 
2018, the fee schedule amount otherwise applicable (both base rate and 
mileage) is reduced by 10 percent, and for ambulance services described 
in section 1834(l)(15) of the Act furnished on or after October 1, 
2018, the fee schedule amount otherwise applicable (both base rate and 
mileage) is reduced by 23 percent. (For further information regarding 
application of this mandated rate decrease, please see CR 10549.)

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

1. Payment for Care Management Services
    In the CY 2018 PFS final rule, we revised the payment methodology 
for Chronic Care Management (CCM) services furnished by RHCs and FQHCs, 
and established requirements and payment for general Behavioral Health 
Integration (BHI) and psychiatric Collaborative Care Management (CoCM) 
services furnished in RHCs and FQHCs, beginning on January 1, 2018.
    For CCM services furnished by RHCs or FQHCs between January 1, 
2016, and December 31, 2017, payment is at the PFS national average 
payment rate for CPT 99490. For CCM, general BHI, and psychiatric CoCM 
services furnished by RHCs or FQHCs on or after January 1, 2018, we 
established 2 new HCPCS codes. The first HCPCS code, G0511, is a 
General Care Management code for use by RHCs or FQHCs when at least 20 
minutes of qualified CCM or general BHI services are furnished to a 
patient in a calendar month. The second HCPCS code, G0512, is a 
psychiatric CoCM code for use by RHCs or FQHCs when at least 70 minutes 
of initial psychiatric CoCM services or 60 minutes of subsequent 
psychiatric CoCM services are furnished to a patient in a calendar 
month.
    The payment amount for HCPCS code G0511 is set at the average of 
the 3 national non-facility PFS payment rates for the CCM and general 
BHI codes and updated annually based on the PFS amounts. The 3 codes 
are CPT 99490 (20 minutes or more of CCM services), CPT 99487 (60 
minutes or more of complex CCM services), and CPT 99484 (20 minutes or 
more of BHI services).
    The payment amount for HCPCS code G0512 is set at the average of 
the 2 national non-facility PFS payment rates for CoCM codes and 
updated annually based on the PFS amounts. The 2 codes are CPT 99492 
(70 minutes or more of initial psychiatric CoCM services) and CPT 99493 
(60 minutes or more of subsequent psychiatric CoCM services).
    For practitioners billing under the PFS, we are proposing for CY 
2019 a new CPT code, 994X7, which would correspond to 30 minutes or 
more of CCM furnished by a physician or other qualified health care 
professional and is similar to CPT codes 99490 and 99487. For RHCs and 
FQHCs, we are proposing to add CPT code 994X7 as a general care 
management service and to include it in the calculation of HCPCS code 
G0511. That is, we propose that starting on January 1, 2019, RHCs and 
FQHC would be paid for G0511 based on the average of the national non-
facility PFS payment rates for CPT codes 99490, 99487, 99484, and 
994X7.
    We propose to revise Sec.  405.2464 to reflect the current payment 
methodology that was finalized in the CY 2018 PFS and incorporate the 
addition of new CPT codes to HCPCS G0511.
2. Communication Technology-Based Services and Remote Evaluations
    RHC and FQHC visits are face-to-face (in-person) encounters between 
a patient and an RHC or FQHC practitioner during which time one or more 
RHC or FQHC qualifying services are furnished. RHC and FQHC 
practitioners are physicians, nurse practitioners, physician 
assistants, certified nurse midwives, clinical psychologists, and 
clinical social workers, and under certain conditions, a registered 
nurse or licensed practical nurse furnishing care to a homebound RHC or 
FQHC patient. A Transitional Care Management service can also be an RHC 
or FQHC visit. A Diabetes Self-Management Training (DSMT) service or a 
Medical Nutrition Therapy (MNT)

[[Page 35864]]

service furnished by a certified DSMT or MNT provider may also be an 
FQHC visit.
    RHCs are paid an all-inclusive rate (AIR) for medically-necessary, 
face-to-face visits with an RHC practitioner. The rate is subject to a 
payment limit, except for those RHCs that have an exception to the 
payment limit for being ``provider-based'' (see Sec.  413.65). FQHCs 
are paid the lesser of their charges or the FQHC Prospective Payment 
System (PPS) rate for medically-necessary, face-to-face visits with an 
FQHC practitioner. Only medically-necessary medical, mental health, or 
qualified preventive health services that require the skill level of an 
RHC or FQHC practitioner can be RHC or FQHC billable visits.
    The RHC and FQHC payment rates reflect the cost of all services and 
supplies that an RHC or FQHC furnishes to a patient in a single day, 
and are not adjusted for the complexity of the patient health care 
needs, the length of the visit, or the number or type of practitioners 
involved in the patient's care.
    Services furnished by auxiliary personnel (such as nurses, medical 
assistants, or other clinical personnel acting under the supervision of 
the RHC or FQHC practitioner) are considered incident to the visit and 
are included in the per-visit payment. This may include services 
furnished prior to or after the billable visit that occur within a 
medically appropriate time period, which is usually 30 days or less.
    RHCS and FQHCs are also paid for care management services, 
including chronic care management services, general behavioral health 
integration services, and psychiatric Collaborative Care Model 
services. These are typically non-face-to-face services that do not 
require the skill level of an RHC or FQHC practitioner and are not 
included in the RHC or FQHC payment methodologies.
    For practitioners billing under the PFS, we are proposing for CY 
2019 separate payment for certain communication technology-based 
services. This includes what is referred to as ``Brief Communication 
Technology-based Service'' for a ``virtual check-in'' and separate 
payment for remote evaluation of recorded video and/or images. The 
``virtual check-in'' visit would be billable when a physician or non-
physician practitioner has a brief (5 to 10 minutes), non-face-to-face 
check in with a patient via communication technology to assess whether 
the patient's condition necessitates an office visit. This service 
could be billed only in situations where the medical discussion was for 
a condition not related to an E/M service provided within the previous 
7 days, and does not lead to an E/M service or procedure within the 
next 24 hours or at the soonest available appointment. We are also 
proposing payment for practitioners billing under the PFS for remote 
evaluation services. This payment would be for the remote evaluation of 
patient-transmitted information conducted via pre-recorded ``store and 
forward'' video or image technology, including interpretation with 
verbal 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. Both of these services would be 
priced under the PFS at a rate that reflects the resource costs of 
these non-face-to-face services relative to other PFS services, 
including face-to-face and in-person visits.
    The RHC and FQHC payment models are distinct from the PFS model in 
that the payment is for a comprehensive set of services and supplies 
associated with an RHC or FQHC visit. A direct comparison between the 
payment for a specific service furnished in an RHC or FQHC and the same 
service furnished in a physician's office is not possible, because the 
payment for RHCs and FQHCs is a per diem payment that includes the cost 
for all services and supplies rendered during an encounter, and payment 
for a service furnished in a physician's office and billed under the 
PFS is only for that service.
    We recognize that there are occasions when it may be beneficial to 
both the patient and the RHC or FQHC to utilize communications-based 
technology to determine the course of action for a health issue. 
Currently under the RHC and FQHC payment systems, if the communication 
results in a face-to-face billable visit with an RHC or FQHC 
practitioner, the cost of the prior communication would be included in 
the RHC AIR or the FQHC PPS. However, if as a result of the 
communication it is determined that a visit is not necessary, there 
would not be a billable visit and there would be no payment.
    RHCs and FQHCs furnish services in rural and urban areas that have 
been determined to be medically underserved areas or health 
professional shortage areas. They are an integral component of the 
Nation's health care safety net, and we want to assure that Medicare 
patients who are served by RHCs and FQHCs are able to communicate with 
their RHC or FQHC practitioner in a manner that enhances access to 
care, consistent with evolving medical care. Particularly in rural 
areas where transportation is limited and distances may be far, we 
believe the use of communication technology may help some patients to 
determine if they need to schedule a visit at the RHC or FQHC. If it is 
determined that a visit is not necessary, the RHC or FQHC practitioner 
would be available for other patients who need their care.
    When communication-based technology services are furnished in 
association with an RHC or FQHC billable visit, the costs of these 
services are included in the RHC AIR or the FQHC PPS and are not 
separately billable. However, if there is no RHC or FQHC billable 
visit, these costs are not paid as part of an RHC AIR or FQHC PPS 
payment. We are therefore proposing that, effective January 1, 2019, 
RHCs and FQHCs receive an additional payment for the costs of 
communication technology-based services or remote evaluation services 
that are not already captured in the RHC AIR or the FQHC PPS payment 
when the requirements for these services are met.
    We propose that RHCs and FQHCs receive payment for communication 
technology-based services or remote evaluation services when at least 5 
minutes of communications-based technology or remote evaluation 
services are furnished by an RHC or FQHC practitioner to a patient that 
has been seen in the RHC or FQHC within the previous year. These 
services may only be billed when the medical discussion or remote 
evaluation is for a condition not related to an RHC or FQHC service 
provided within the previous 7 days, and does not lead to an RHC or 
FQHC service within the next 24 hours or at the soonest available 
appointment, since in those situation the services are already paid as 
part of the RHC or FQHC per-visit payment.
    We propose to create a new Virtual Communications G code for use by 
RHCs and FQHCs only, with a payment rate set at the average of the PFS 
national non-facility payment rates for HCPCS code GVCI1 for 
communication technology-based services, and HCPCS code GRAS1 for 
remote evaluation services. RHCs and FQHCs would be able to bill the 
Virtual Communications G-code either alone or with other payable 
services. The payment rate for the Virtual Communications G-code would 
be updated annually based on the PFS amounts.
    We also propose to waive the RHC and FQHC face-to-face requirements 
when these services are furnished to an

[[Page 35865]]

RHC or FQHC patient. Coinsurance would be applied to FQHC claims, and 
coinsurance and deductibles would apply to RHC claims for these 
services. Services that are currently being furnished and paid under 
the RHC AIR or FQHC PPS payment methodology will not be affected by the 
ability of the RHC or FQHC to receive payment for additional services 
that are not included in the RHC AIR or FQHC PPS.
3. Other Options Considered
    We considered other options for payment for these services. First, 
we considered adding communication technology-based and remote 
evaluation services as an RHC or FQHC stand-alone service. Under this 
option, payment for RHCs would be at the AIR, and payment for FQHCs 
would be the lesser of total charges or the PPS rate. We are not 
proposing this payment option because these services do not meet the 
requirements for an RHC or FQHC billable visit and payment at the RHC 
AIR or FQHC PPS would result in a payment rate incongruent with 
efficiencies inherent in the provision of the technology-based 
services.
    The second option we considered was to allow RHCs and FQHCs to bill 
HCPCS codes GVCI1 or GRAS1 separately on an RHC or FQHC claim. We are 
not proposing this payment option because we believe that a combined G 
code is less burdensome and will allow expansion of these services 
without adding additional codes on an RHC or FQHC claim.
    We invite comments on this proposal. In particular, we are 
interested in comments regarding the appropriateness of payment for 
communication technology-based and remote evaluation services in the 
absence of an RHC or FQHC visit, the burden associated with 
documentation for billing these codes (RHC or FQHC practitioner's time, 
medical records, etc.), and any potential impact on the per diem nature 
of RHC and FQHC billing and payment structure as a result of payment 
for these services. We are also seeking public comment on whether it 
would be clinically appropriate to apply a frequency limitation on the 
use of the new Virtual Communications G code by the same RHC or FQHC 
with the same patient, and on what would be a reasonable frequency 
limitation to ensure that this code is appropriately utilized.
4. Other Regulatory Updates
    In addition to the regulatory change described in this section of 
the rule, we propose the following for accuracy:
     Removal of the extra section mark in the definition of 
``Federally qualified health center (FQHC)'' in Sec.  405.2401.
     Replacing the word ``his'' with ``his or her'' in the 
definition of ``Secretary'' in Sec.  405.2401.

D. Appropriate Use Criteria for Advanced Diagnostic Imaging Services

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

[[Page 35866]]

an evidence-based guideline for a particular clinical scenario based on 
a patient's presenting symptoms or condition.
    AUC need to be integrated as seamlessly as possible into the 
clinical workflow. CDSMs are the electronic portals through which 
clinicians access the AUC during the patient workup. They can be 
standalone applications that require direct entry of patient 
information, but may be more effective when they are integrated into 
Electronic Health Records (EHRs). Ideally, practitioners would interact 
directly with the CDSM through their primary user interface, thus 
minimizing interruption to the clinical workflow.
2. Statutory Authority
    Section 218(b) of the PAMA added a new section 1834(q) of the Act 
entitled, ``Recognizing Appropriate Use Criteria for Certain Imaging 
Services,'' which directs the Secretary to establish a new program to 
promote the use of AUC. Section 1834(q)(4) of the Act requires ordering 
professionals to consult with specified applicable AUC through a 
qualified CDSM for applicable imaging services furnished in an 
applicable setting and paid for under an applicable payment system; and 
payment for such service may only be made if the claim for the service 
includes information about the ordering professional's consultation of 
specified applicable AUC through a qualified CDSM.
3. Discussion of Statutory Requirements
    There are four major components of the AUC program under section 
1834(q) of the Act, and each component has its own implementation date: 
(1) Establishment of AUC by November 15, 2015 (section 1834(q)(2) of 
the Act); (2) identification of mechanisms for consultation with AUC by 
April 1, 2016 (section 1834(q)(3) of the Act); (3) AUC consultation by 
ordering professionals, and reporting on AUC consultation by January 1, 
2017 (section 1834(q)(4) of the Act); and (4) annual identification of 
outlier ordering professionals for services furnished after January 1, 
2017 (section 1834(q)(5) of the Act). We did not identify mechanisms 
for consultation by April 1, 2016. Therefore, we did not require 
ordering professionals to consult CDSMs or furnishing professionals to 
report information on the consultation by the January 1, 2017 date.
a. Establishment of AUC
    In the CY 2016 PFS final rule with comment period, we addressed the 
first component of the Medicare AUC program under section 1834(q)(2) of 
the Act--the requirements and process for establishment and 
specification of applicable AUC, along with relevant aspects of the 
definitions under section 1834(q)(1) of the Act. This included defining 
the term PLE (provider-led entity) and finalizing requirements for the 
rigorous, evidence-based process by which a PLE would develop AUC, upon 
which qualification is based, as provided in section 1834(q)(2)(B) of 
the Act and in the CY 2016 PFS final rule with comment period. Using 
this process, once a PLE is qualified by CMS, the AUC that are 
developed, modified or endorsed by the qualified PLE are considered to 
be specified applicable AUC under section 1834(q)(2)(A) of the Act. We 
defined PLE to include national professional medical societies, health 
systems, hospitals, clinical practices and collaborations of such 
entities such as the High Value Healthcare Collaborative or the 
National Comprehensive Cancer Network. Qualified PLEs may collaborate 
with third parties that they believe add value to their development of 
AUC, provided such collaboration is transparent. We expect qualified 
PLEs to have sufficient infrastructure, resources, and the relevant 
experience to develop and maintain AUC according to the rigorous, 
transparent, and evidence-based processes detailed in the CY 2016 PFS 
final rule with comment period.
    In the same rule we established a timeline and process under Sec.  
414.94(c)(2) for PLEs to apply to become qualified. Consistent with 
this timeline the first list of qualified PLEs was published at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/PLE.html in June 2016 (OMB 
Control Number 0938-1288).
b. Mechanism for AUC Consultation
    In the CY 2017 PFS final rule, we addressed the second major 
component of the Medicare AUC program--the specification of qualified 
CDSMs for use by ordering professionals for consultation with specified 
applicable AUC under section 1834(q)(3) of the Act, along with relevant 
aspects of the definitions under section 1834(q)(1) of the Act. This 
included defining the term CDSM and finalizing functionality 
requirements of mechanisms, upon which qualification is based, as 
provided in section 1834(q)(3)(B) of the Act and in the CY 2017 PFS 
final rule. CDSMs may receive full qualification or preliminary 
qualification if most, but not all, of the requirements are met at the 
time of application. The preliminary qualification period began June 
30, 2017 and ends when the AUC consulting and reporting requirements 
become effective on January 1, 2020. The preliminarily qualified CDSMs 
must meet all requirements by that date. We defined CDSM as an 
interactive, electronic tool for use by clinicians that communicates 
AUC information to the user and assists them in making the most 
appropriate treatment decision for a patient's specific clinical 
condition. Tools may be modules within or available through certified 
EHR technology (as defined in section 1848(o)(4) of the Act) or private 
sector mechanisms independent from certified EHR technology or a 
mechanism established by the Secretary.
    In the CY 2017 PFS final rule, we established a timeline and 
process in Sec.  414.94(g)(2) for CDSM developers to apply to have 
their CDSMs qualified. Consistent with this timeline, the first list of 
qualified CDSMs was published at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/CDSM.html in July 2017 (OMB Control Number 0938-1315).
c. AUC Consultation and Reporting
    In the CY 2018 PFS final rule, we addressed the third major 
component of the Medicare AUC program--consultation with applicable AUC 
by the ordering professional and reporting of such consultations under 
section 1834(q)(4) of the Act. We established a January 1, 2020 
effective date for the AUC consultation and reporting requirements for 
this program. We also established a voluntary period during which early 
adopters can begin reporting limited consultation information on 
Medicare claims from July 2018 through December 2019. During the 
voluntary period there is no requirement for ordering professionals to 
consult AUC or furnishing professionals to report information related 
to the consultation. On January 1, 2020, the program will begin with an 
educational and operations testing period and during this time we will 
continue to pay claims whether or not they correctly include AUC 
consultation information. Ordering professionals must consult specified 
applicable AUC through qualified CDSMs for applicable imaging services 
furnished in an applicable setting, paid for under an applicable 
payment system and ordered on or after January 1, 2020; and furnishing 
professionals must report the AUC consultation information on the 
Medicare claim for these services ordered on or after January 1, 2020.
    Consistent with section 1834(q)(4)(B) of the Act, we also 
established that furnishing professionals must report the

[[Page 35867]]

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

[[Page 35868]]

service is furnished and billed by the same entity; or payment can be 
made separately for the technical component (TC) of the service and the 
professional component (PC) when those portions of the service are 
furnished and billed by different entities. In general, the TC for an 
advanced diagnostic imaging service is the portion of the test during 
which the patient is present and the image is captured. The PC is the 
portion of the test that involves a physician's interpretation and 
report on the captured image. For example, when a CT scan is ordered by 
a patient's treating physician, the entire test (TC and PC) could be 
furnished by a radiologist in their office and billed as a ``global'' 
service. Alternatively, the TC could be furnished and billed by an 
IDTF, and the PC could be furnished and billed by a radiologist in 
private practice. By adding IDTFs as an applicable setting, we believe 
we would appropriately and consistently apply the AUC program across 
the range of outpatient settings where applicable imaging services are 
furnished.
    We propose to revise the definition of applicable setting under 
Sec.  414.94(b) to include an IDTF. We invite comments on this proposal 
and on the possible inclusion of any other applicable setting. We 
remind commenters that application of the AUC program is not only 
limited to applicable settings, but also to services for which payment 
is made under applicable payment systems (the physician fee schedule, 
the OPPS, and the ASC payment system).
b. Consultations by Ordering Professionals
    Section 1834(q)(1)(E) of the Act defines the term ``ordering 
professional'' as a physician (as defined in section 1861(r)) or a 
practitioner described in section 1842(b)(18)(C) who orders an 
applicable imaging service. The AUC consultation requirement applies to 
these ordering professionals. We are proposing that the consultation 
with AUC through a qualified CDSM may be performed by clinical staff 
working under the direction of the ordering professional, subject to 
applicable State licensure and scope of practice law, when the 
consultation is not performed personally by the ordering professional 
whose NPI will be listed on the order for an advanced imaging service.
    In response to the CY 2018 PFS proposed rule, we received several 
public comments requesting clarification regarding who is required to 
perform the consultation of AUC through a qualified CDSM. Commenters 
not only sought clarification, but also provided recommendations for 
requirements around this topic. Some commenters recommended that CMS 
strictly interpret the statutory language and only allow the clinician 
placing the order to perform the consultation and others recommended 
that CMS allow others to perform the AUC consultation on behalf of the 
clinician.
    Section 1834(q)(4)(A)(i) of the Act requires an ordering 
professional to consult with a qualified CDSM, and this was codified in 
our regulations at Sec.  414.94(j). The statute does not explicitly 
provide for consultations under the AUC program to be fulfilled by 
other professionals, individuals or organizations on behalf of the 
ordering professional; however, we continue to seek ways to minimize 
the burden of this new Medicare program and understand that many 
practices currently use clinical staff, working under the direction of 
the ordering professional, to interact with the CDSM for AUC 
consultation and subsequent ordering of advanced diagnostic imaging. 
Therefore, we propose to modify paragraph Sec.  414.94(j) to specify 
that additional individuals may perform the required AUC consultation.
    When the AUC consultation is not performed personally by the 
ordering professional, we propose the consultation may be performed by 
auxiliary personnel incident to the ordering physician or non-physician 
practitioner's professional service. We believe this approach is 
appropriate under this program and still accomplishes the goal of 
promoting the use of AUC. This proposed policy would allow the ordering 
professional to exercise their discretion to delegate the performance 
of this consultation. It is important to note that the ordering 
professional is ultimately responsible for the consultation as their 
NPI is reported by the furnishing professional on the claim for the 
applicable imaging service; and that it is the ordering professional 
who could be identified as an outlier ordering professional and become 
subject to prior authorization based on their ordering pattern.
    We propose to revise the AUC consultation requirement specified at 
Sec.  414.94(j) to specify that the AUC consultation may be performed 
by auxiliary personnel under the direction of the ordering professional 
and incident to the ordering professional's services.
c. Reporting AUC Consultation Information
    Section 1834(q)(4)(B) of the Act requires that payment for an 
applicable imaging service furnished in an applicable setting and paid 
for under an applicable payment system may only be made if the claim 
for the service includes certain information about the AUC 
consultation. As such, the statute requires that AUC consultation 
information be included on any claim for an outpatient advanced 
diagnostic imaging service, including those billed and paid under any 
applicable payment system (the PFS, OPPS or ASC payment system). When 
we initially codified the AUC consultation reporting requirement in 
Sec.  414.94(k) through rulemaking in the CY 2018 PFS final rule, we 
specified only that ``furnishing professionals'' must report AUC 
consultation information on claims for applicable imaging services. 
This led some stakeholders to believe that AUC consultation information 
would be required only on practitioner claims. To better reflect the 
statutory requirements of section 1834(q)(4)(B) of the Act, we are 
proposing to revise our regulations to clarify that AUC consultation 
information must be reported on all claims for an applicable imaging 
service furnished in an applicable setting and paid for under an 
applicable payment system. The revised regulation would more clearly 
express the scope of advanced diagnostic imaging services that are 
subject to the AUC program, that is, those furnished in an applicable 
setting and paid under an applicable payment system.
    The language codified in Sec.  414.94(k) uses the term furnishing 
professional to describe who must report the information on the 
Medicare claims. We recognize that section 1834(q)(1)(F) of the Act 
specifies that a ``furnishing professional'' is a physician (as defined 
in section 1861(r)) or a practitioner described in section 
1842(b)(18)(C) who furnishes an applicable imaging service. However, 
because section 1834(q)(4)(B) of the Act, as described above, clearly 
includes all claims paid under applicable payment systems without 
exclusion, we believe that the claims from both furnishing 
professionals and facilities must include AUC consultation information. 
In other words, we would expect this information to be included on the 
practitioner's claim for the professional component of the applicable 
advanced diagnostic imaging service and on the provider's or supplier's 
claim for the facility portion or TC of the imaging service.
    As such, we propose to revise Sec.  414.94(k) to clearly reflect 
the scope of claims for which AUC consultation information must be 
reported, and to clarify that the requirement to report AUC 
consultation information is not limited to the furnishing professional.

[[Page 35869]]

d. Claims-Based Reporting
    In the CY 2018 PFS proposed rule (82 FR 34094) we discussed using a 
combination of G-codes and modifiers to report the AUC consultation 
information on the Medicare claim. We received numerous public comments 
objecting to this potential solution. In the 2018 PFS final rule, we 
agreed with many of the commenters that additional approaches to 
reporting AUC consultation information on Medicare claims should be 
considered, and we learned from many commenters that reporting a unique 
consultation identifier (UCI) would be a less burdensome and preferred 
approach. The UCI would include all the information required under 
section 1834(q)(4)(B) of the Act including an indication of AUC 
adherence, non-adherence and not applicable responses. Commenters noted 
that capturing a truly distinguishing UCI on the claim will allow for 
direct mapping from a single AUC consultation to embedded information 
within a CDSM. We indicated that we would work with stakeholders to 
further explore the concept of using a UCI to satisfy the requirements 
of section 1834(q)(4)(B) of the Act, which will be used for Medicare 
claims processing and, ultimately, for the identification of outlier 
ordering professionals, and consider developing a taxonomy for a UCI.
    We had the opportunity to engage with some stakeholders over the 
last 6 months and we understand that some commenters from the previous 
rule continue to be in favor of a UCI, while some may have changed 
their position upon further consideration.
    We provide the following information to summarize alternatives we 
considered. CMS had originally considered assigning a G-code for every 
qualified CDSM with a code descriptor containing the name of the 
qualified CDSM. The challenge to this approach arises when there is 
more than one advanced imaging service on a single claim. CMS could 
attribute a single G-code to all of the applicable imaging services for 
the patient's clinical condition on the claim, which might be 
appropriate if each AUC consultation for each service was through the 
same CDSM. If a different CDSM was used for each service (for example, 
when services on a single claim were ordered by more than one ordering 
professional and each ordering professional used a different CDSM) then 
multiple G-codes could be needed on the claim. Each G-code would appear 
on the claim individually as its own line item. As a potential 
solution, we considered the use of modifiers, which are appealing 
because they would appear on the same line as the CPT code that 
identifies the specific billed service. Therefore, information entered 
onto a claim would arrive into the claims processing system paired with 
the relevant AUC consultation information.
    When reporting the required AUC consultation information based on 
the response from a CDSM: (1) The imaging service would adhere to the 
applicable AUC; (2) the imaging service would not adhere to such 
criteria; or (3) such criteria were not applicable to the imaging 
service ordered, three modifiers could be developed. These modifiers, 
when placed on the same line with the CPT code for the advanced imaging 
service would allow this information to be easily accessed in the 
Medicare claims data and matched with the imaging service.
    Stakeholders have made various suggestions for a taxonomy that 
could be used to develop a UCI to report the required information. 
Stakeholders have also considered where to place the UCI on the claim. 
We understand the majority of solutions suggested by stakeholders 
involving a UCI are claim-level solutions and would not allow CMS to 
attribute the CDSM used or the AUC adherence status (adherent or not 
adherent, or not applicable) to a specific imaging service. As such, 
the approach of using a UCI would not identify whether an AUC 
consultation was performed for each applicable imaging service reported 
on a claim form, or be useful for purposes of identifying outlier 
ordering professionals in accordance with section 1834(q)(5) of the 
Act.
    We have received ideas from stakeholders that are both for and 
against the two approaches we have identified; and we appreciate the 
stakeholders that have provided additional information or engaged us in 
this discussion. Internally, we have explored the possibility of using 
and feasibility of developing a UCI, and concluded that, although we 
initiated this approach during the CY 2018 PFS final rule, it is not 
feasible to create a uniform UCI taxonomy, determine a location of the 
UCI on the claims forms, obtain the support and permission by national 
bodies to use claim fields for this purpose, and solve the underlying 
issue that the UCI seems limited to claim-level reporting. Using coding 
structures that are already in place (such as G-codes and modifiers) 
would allow CMS to establish reporting requirements prior to the start 
of the program (January 1, 2020).
    Since we did not finalize a proposal in the CY 2018 PFS final rule, 
we propose in this rule to use established coding methods, to include 
G-codes and modifiers, to report the required AUC information on 
Medicare claims. This will allow the program to be implemented by 
January 1, 2020. We will consider future opportunities to use a UCI and 
look forward to continued engagement with and feedback from 
stakeholders.
e. Significant Hardship Exception
    We are proposing to revise Sec.  414.94(i)(3) of our regulations to 
adjust the significant hardship exception requirements under the AUC 
program. We are proposing criteria specific to the AUC program and 
independent of other programs. An ordering professional experiencing 
any of the following when ordering an advanced diagnostic imaging 
service would not be required to consult AUC using a qualified CDSM, 
and the claim for the applicable imaging service would not be required 
to include AUC consultation information. The proposed criteria include:
     Insufficient internet access;
     EHR or CDSM vendor issues; or
     Extreme and uncontrollable circumstances.
    Insufficient internet access is specific to the location where an 
advanced diagnostic imaging service is ordered by the ordering 
professional. EHR or CDSM vendor issues may include situations where 
ordering professionals experience temporary technical problems, 
installation or upgrades that temporarily impede access to the CDSM, 
vendors cease operations, or CMS de-qualifies a CDSM. CMS expects these 
situations to generally be irregular and unusual. Extreme and 
uncontrollable circumstances include disasters, natural or man-made, 
that have a significant negative impact on healthcare operations, area 
infrastructure or communication systems. These could include areas 
where events occur that have been designated a Federal Emergency 
Management Agency (FEMA) major disaster or a public health emergency 
declared by the Secretary. Based on 2016 data from the Medicare EHR 
Incentive Program and the 2019 payment year MIPS eligibility and 
special status file, we estimate that 6,699 eligible clinicians could 
submit such a request due to extreme and uncontrollable circumstances 
or as a result of a decertification of an EHR, which represents less 
than 1-percent of available ordering professionals.
    In the CY 2017 PFS final rule, for purposes of the AUC program 
significant hardship exceptions, we

[[Page 35870]]

provided that those who received significant hardship exceptions in the 
following categories from Sec.  495.102(d)(4) would also qualify for 
significant hardship exceptions for the AUC program:
     Insufficient Internet Connectivity (as specified in Sec.  
495.102(d)(4)(i)).
     Practicing for less than 2 years (as specified in Sec.  
495.102(d)(4)(ii)).
     Extreme and Uncontrollable Circumstances (as specified in 
Sec.  495.102(d)(4)(iii)).
     Lack of Control over the Availability of CEHRT (as 
specified in Sec.  495.102(d)(4)(iv)(A)).
     Lack of Face-to-Face Patient Interaction (as specified in 
Sec.  495.102(d)(4)(iv)(B)).
    In the CY 2018 PFS proposed rule, we proposed to amend the AUC 
significant hardship exception regulation to specify that ordering 
professionals who are granted reweighting of the Advancing Care 
Information (ACI) performance category to zero percent of the final 
score for the year under MIPS per Sec.  414.1380(c)(2) due to 
circumstances that include the criteria listed in Sec.  
495.102(d)(4)(i), (d)(4)(iii), and (d)(4)(iv)(A) and (B) (as outlined 
in the bulleted list above) would be excepted from the AUC consultation 
requirement during the same year that the re-weighting applies for 
purposes of the MIPS payment adjustment. This proposal removed Sec.  
495.102(d)(4)(ii), practicing for less than 2 years, as a criterion 
since these clinicians are not MIPS eligible clinicians and thus would 
never meet the criteria for reweighting of their MIPS ACI performance 
category for the year.
    In response to public comments, we did not finalize the proposed 
changes to the significant hardship exceptions in the CY 2018 PFS final 
rule and instead decided further evaluation was needed before moving 
forward with any modifications. As we have continued to evaluate both 
policy options and operational considerations for the AUC significant 
hardship exception, we have concluded that the most appropriate 
approach, which we consider to be more straightforward and less 
burdensome than the current approach, involves establishing significant 
hardship criteria and a process that is independent from other Medicare 
programs. Our original intention was to design the AUC significant 
hardship exception process in alignment with the process for the 
Medicare EHR Incentive Program for eligible professionals, and then for 
the MIPS ACI (now Promoting Interoperability) performance category. 
Under section 1848(a)(7)(A) of the Act, the downward payment adjustment 
for eligible professionals under the Medicare EHR Incentive Program 
will end in 2018, and we are unable to continue making reference to a 
regulation relating to a program that is no longer in effect. We also 
note as we have in the past that the AUC program is a real-time program 
with a need for real-time significant hardship exceptions. This is in 
contrast to the way significant hardship exceptions are handled under 
MIPS where the hardship might impact some or all of a performance 
period, or might impact reporting, both of which occur well before the 
MIPS payment adjustment is applied in a subsequent year. We recognize 
that when a significant hardship arises, an application process to 
qualify for an exception becomes a time consuming hurdle for health 
care providers to navigate, and we believe that it is important to 
minimize the burden involved in seeking significant hardship 
exceptions. As such, we are proposing that ordering professionals would 
self-attest if they are experiencing a significant hardship at the time 
of placing an advanced diagnostic imaging order and such attestation be 
supported with documentation of significant hardship. Ordering 
professionals attesting to a significant hardship would communicate 
that information, along with the AUC consultation information, to the 
furnishing professional with the order and it would be reflected on the 
furnishing professional's and furnishing facility's claim by appending 
a HCPCS modifier. The modifier would indicate that the ordering 
professional has self-attested to experiencing a significant hardship 
and communicated this to the furnishing professional with the order. 
Claims for advanced diagnostic imaging services that include a 
significant hardship exception modifier would not be required to 
include AUC consultation information.
    In addition to the proposals above, we invite the public to comment 
on any additional circumstances that would cause the act of consulting 
AUC to be particularly difficult or challenging for the ordering 
professional, and for which it may be appropriate for an ordering 
professional to be granted a significant hardship exception under the 
AUC program. While we understand the desire by some for significant 
hardship categories unrelated to difficulty in consulting AUC through a 
CDSM, we remind readers that circumstances that are not specific to AUC 
consultation, such as the ordering professional being in clinical 
practice for a short period of time or having limited numbers of 
Medicare patients, would not impede clinicians from consulting AUC 
through a CDSM as required to meet the requirements of this program.
f. Identification of Outliers
    As previously mentioned, the fourth component of the AUC program 
specified in section 1834(q)(5) of the Act, is the identification of 
outlier ordering professionals. In our efforts to start a dialogue with 
stakeholders, we would like to invite the public to submit their ideas 
on a possible methodology for the identification of outlier ordering 
professionals who would eventually be subject to a prior authorization 
process when ordering advanced diagnostic imaging services. 
Specifically, we are soliciting comments on the data elements and 
thresholds that CMS should consider when identifying outliers. We also 
intend to perform and use analysis to assist us in developing the 
outlier methodology for the AUC program. Our existing prior 
authorization programs generally do not specifically focus on outliers. 
We are interested in hearing ideas from the public on how outliers 
could be determined for the AUC program. Because we would be concerned 
about data integrity and reliability, we do not intend to include data 
from the educational and operations testing period in CY 2020 in the 
analysis used to develop our outlier methodology. Since we intend to 
evaluate claims data to inform our methodology we expect to address 
outlier identification and prior authorization more fully in CY 2022 or 
2023 rulemaking. As noted above, we expect to solicit public comment to 
inform our methodology through rulemaking before finalizing our 
approach.
    We note that we may not provide comprehensive comment summaries and 
responses to comments submitted in response to this solicitation. 
Rather, we will actively consider all input as we develop the 
methodology for the identification of outliers.
5. Summary
    Section 1834(q) of the Act includes rapid timelines for 
establishing a Medicare AUC program for advanced diagnostic imaging 
services. The impact of this program is extensive as it will apply to 
every physician or other practitioner who orders or furnishes advanced 
diagnostic imaging services (for example, MRI, computed tomography (CT) 
or positron emission tomography (PET)). This crosses almost every 
medical specialty and could have a particular impact on primary care

[[Page 35871]]

physicians since their scope of practice can be quite broad.
    We continue to believe the best implementation approach is one that 
is diligent, maximizes the opportunity for public comment and 
stakeholder engagement, and allows for adequate advance notice to 
physicians and practitioners, beneficiaries, AUC developers, and CDSM 
developers. It is for these reasons we propose to continue a stepwise 
approach, adopted through notice and comment rulemaking.
    In summary, we are proposing policies to modify existing 
requirements and criteria and to provide further clarification on 
implementation of the AUC program. We include a proposal to add IDTFs 
to the definition of applicable settings under this program. We also 
include proposals regarding who beyond the ordering professional may 
consult AUC through a qualified CDSM to meet the statutory requirements 
for the AUC program, as well as a proposal to more clearly include all 
entities required to report AUC consultation information on the claim. 
Finally, we propose to modify the significant hardship exception 
criteria and process under Sec.  414.94(i)(3) to be specific to the AUC 
program and independent of other Medicare programs. We are also 
requesting public comment on other circumstances that could be 
considered significant hardships, posing particular real-time 
difficulty or challenge to the ordering professional in consulting AUC. 
We invite the public to submit comments on these proposals, as well as 
provide comment on potential methods for, and issues related to, 
mechanisms for claims-based reporting and identifying outlier ordering 
professionals.
    We will continue to post information on our website for this 
program, accessible at www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/.

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

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

[[Page 35872]]

EPs the e-specified measures from the Core Sets that are not also on 
the MIPS eCQM list would increase EP utilization of these measures and 
provide states with better data to report. At this time, the only 
measure within the Core Sets that would not be available as an option 
for Medicaid EPs in 2019 (because it is not on the MIPS eCQM list) is 
NQF-1360, ``Audiological Diagnosis No Later Than 3 Months of Age.'' 
However, as these Core Sets are updated annually, there may be other 
eCQMs that could be included in future years.
    For 2019, we propose that Medicaid EPs would report on any six 
eCQMs that are relevant to the EP's scope of practice, regardless of 
whether they report via attestation or electronically. After we removed 
the NQS domain requirements for EPs' 2017 eCQM submissions in the FY 
2018 IPPS/LTCH PPS final rule, we have found that allowing EPs to 
report on any six quality measures that are relevant to their practice 
has increased EPs' flexibility to report pertinent data. In addition, 
this policy would generally align with the MIPS data submission 
requirement for eligible clinicians using the eCQM collection type for 
the quality performance category, which is established at Sec.  
414.1335(a)(1). MIPS eligible clinicians who elect to submit eCQMs must 
submit data on at least six quality measures, including at least one 
outcome measure (or, if an applicable outcome measure is not available, 
one other high priority measure). We refer readers to Sec.  
414.1335(a)(2) and (3) for the data submission criteria that apply to 
individual MIPS eligible clinicians and groups who elect to submit data 
for other collection types.
    We also propose that for 2019 the Medicaid Promoting 
Interoperability Program would adopt the MIPS requirement that EPs 
report on at least one outcome measure (or, if an applicable outcome 
measure is not available or relevant, one other high priority measure). 
We also request comments on how high priority measures should be 
identified for Medicaid EPs. We propose to use all three of the 
following methods to identify which of the available measures are high 
priority measures, but invite comments on other possibilities.
    1. We would use the same set of high priority measures for EPs 
participating in the Medicaid Promoting Interoperability Program that 
the MIPS program has identified for eligible clinicians. We note that 
in section III.H., we are proposing to amend Sec.  414.1305 to revise 
the definition of high priority measure for purposes of MIPS to mean an 
outcome (including intermediate-outcome and patient-reported outcome), 
appropriate use, patient safety, efficiency, patient experience, care 
coordination, or opioid-related quality measure, beginning with the 
2021 MIPS payment year.
    2. For 2019, we would also identify as high priority measures the 
available eCQMs that are included in the previous year's Core Sets and 
that are also included on the MIPS list of eCQMs. Because the Core Sets 
are released at the beginning of each year, it would not be possible to 
update the list of high-priority eCQMs with those added to the current 
year's Core Sets. CMS has already identified the measures included in 
the Core Sets as ones that specifically focus on populations served by 
the Medicaid and CHIP programs and are particularly important to their 
care. The eCQMs that would be available for EPs to report in 2019, that 
are both part of the Core Sets and on the MIPS list of eCQMs, and that 
would be considered high priority measures under our proposal are: 
CMS2, ``Preventive Care and Screening: Screening for Depression and 
Follow-Up Plan''; CMS4, ``Initiation and Engagement of Alcohol and 
Other Drug Dependence Treatment''; CMS122, ``Diabetes: Hemoglobin A1c 
(HbA1c) Poor Control (>9%)''; CMS125, ``Breast Cancer Screening''; 
CMS128, ``Anti-depressant Medication Management''; CMS136, ``Follow-Up 
Care for Children Prescribed ADHD Medication (ADD)''; CMS153, 
``Chlamydia Screening for Women''; CMS155, ``Weight Assessment and 
Counseling for Nutrition and Physical Activity for Children and 
Adolescents''; and CMS165, ``Controlling High Blood Pressure.''
    3. We would also give each state the flexibility to identify which 
of the available eCQMs selected by CMS are high priority measures for 
EPs in that state, with review and approval from CMS, through their 
State Medicaid HIT Plans (SMHP), similar to the flexibility granted 
states to modify the definition of Meaningful Use at Sec.  495.332(f). 
This would give states the ability to identify as high priority those 
measures that align with their state health goals or other programs 
within the state. We proposed to amend Sec.  495.332(f) to provide for 
this state flexibility to identify high priority measures.
    We propose that any eCQMs identified via any of these mechanisms be 
considered to be high priority measures for EPs participating in the 
Medicaid Promoting Interoperability Program for 2019. We invite 
comments on whether all three of these methods should be utilized (as 
proposed) or whether there are reasons to instead use a subset of these 
methods, or only one of them.
    We also propose that the eCQM reporting period for EPs in the 
Medicaid Promoting Interoperability Program would be a full CY in 2019 
for EPs who have demonstrated meaningful use in a prior year, in order 
to align with the corresponding performance period in MIPS for the 
quality performance category. We continue to align Medicaid Promoting 
Interoperability Program requirements with requirements for other CMS 
quality programs, such as MIPS, to the extent practicable, to reduce 
the burden of reporting different data for separate programs. In 
addition, we have found that clinical quality data from an entire year 
reporting period is significantly more useful than partial year data 
for quality measurement and improvement because it gives states a 
fuller picture of a health care provider's care and patient outcomes. 
The eCQM reporting period for EPs demonstrating meaningful use for the 
first time, which was established in the final rule entitled ``Medicare 
and Medicaid Programs; Electronic Health Record Incentive Program--
Stage 3 and Modifications to Meaningful Use in 2015 Through 2017'' (80 
FR 62762) (hereafter referred to as ``Stage 3 final rule''), would 
remain any continuous 90-day period (80 FR 62892).
    We will adjust future years' requirements for reporting eCQMs in 
the Medicaid Promoting Interoperability Program as necessary, through 
rulemaking, and will continue to align the quality reporting 
requirements, as logical and feasible, to minimize EP burden.
    We invite public comment on these proposals.
3. Proposed Revisions to the EHR Reporting Period and eCQM Reporting 
Period in 2021 for EPs Participating in the Medicaid Promoting 
Interoperability Program
    In the July 28, 2010 final rule titled ``Medicare and Medicaid 
Programs; Electronic Health Record Incentive Program'' at 75 FR 44319, 
we established that, in accordance with section 1903(t)(4)(A)(iii) of 
the Act, in no case may any Medicaid EP receive an incentive after 2021 
(see Sec.  495.310(a)(2)(v)). Therefore, December 31, 2021 is the last 
date that states could make Medicaid Promoting Interoperability Program 
payments to Medicaid EPs (other than pursuant to a successful appeal 
related to 2021 or a prior year).
    For states to make payments by that deadline, there must be 
sufficient time after EHR and eCQM reporting periods

[[Page 35873]]

end for EPs to attest to states, for states to conduct their prepayment 
processes, and for states to issue payments. Therefore, we propose to 
amend Sec.  495.4 to provide that the EHR reporting period in 2021 for 
all EPs in the Medicaid Promoting Interoperability Program would be a 
minimum of any continuous 90-day period within CY 2021, provided that 
the end date for this period falls before October 31, 2021, to help 
ensure that the state can issue all Medicaid Promoting Interoperability 
Program payments on or before December 31, 2021. Similarly, we propose 
to change the eCQM reporting period in 2021 for EPs in the Medicaid 
Promoting Interoperability Program to a minimum of any continuous 90-
day period within CY 2021, provided that the end date for this period 
falls before October 31, 2021, to help ensure that the state can issue 
all Medicaid Promoting Interoperability Program payments on or before 
December 31, 2021.
    We understand that the October 31, 2021 date might not provide some 
states with sufficient time to process payments by December 31, 2021. 
We believe that states are best positioned to determine the last 
possible date in CY 2021 by which the EHR or eCQM reporting periods for 
Medicaid EPs must end, and the deadline for receiving EP attestations, 
so that the state is able to issue all payments by December 31, 2021. 
Therefore, we propose to allow states the flexibility to set 
alternative, earlier final deadlines for EHR or eCQM reporting periods 
for Medicaid EPs in CY 2021, with prior approval from us, through their 
State Medicaid HIT Plan (SMHP). If a state establishes an alternative, 
earlier date within CY 2021 by which all EHR or eCQM reporting periods 
in CY 2021 must end, Medicaid EPs in that state would continue to have 
a reporting period of a minimum of any continuous 90-day period within 
CY 2021. The end date for the reporting period would have to occur 
before the day of attestation, which must occur prior to the final 
deadline for attestations established by their state. We proposed to 
amend Sec.  495.332(f) to provide for this state flexibility to 
identify an alternative date by which all EHR reporting periods or eCQM 
reporting periods for Medicaid EPs in CY 2021 must end.
    We believe there is no reason why a state would need to set a date 
by which EHR reporting periods and eCQM reporting periods must end for 
Medicaid EPs that is earlier than the day before that state's 
attestation deadline for EPs. Doing so would restrict EPs' ability to 
select EHR and eCQM reporting periods. Therefore, we propose that any 
alternative deadline for CY 2021 EHR and eCQM reporting periods set by 
a state may not be any earlier than the day prior to the attestation 
deadline for Medicaid EPs attesting to that state.
    We invite public comment on this proposal.
    While we are not making any proposals regarding eligible hospitals 
in this proposed rule, we acknowledge that there will be a similar 
issue if there are still hospitals eligible to receive Medicaid 
Promoting Interoperability Program payments in 2021, including 
Medicaid-only eligible hospitals as well as ``dually-eligible'' 
eligible hospitals and critical access hospitals (CAHs) (those that are 
eligible for an incentive payment under Medicare for meaningful use of 
CEHRT and/or subject to the Medicare payment reduction for failing to 
demonstrate meaningful use of CEHRT, and are also eligible to earn a 
Medicaid incentive payment for meaningful use of CEHRT). However, based 
on attestation data and information from states' SMHPs regarding the 
number of years states disburse Medicaid Promoting Interoperability 
Program payments to hospitals, we believe that there will be no 
hospitals eligible to receive Medicaid Promoting Interoperability 
Program payments in 2021 due to the requirement that, after 2016, 
eligible hospitals cannot receive a Medicaid Promoting Interoperability 
Program payment unless they have received such a payment in the prior 
fiscal year. At this time, we believe that there are no hospitals that 
will be able to receive incentive payments in 2020 or 2021. We invite 
comments and suggestions on whether this belief is accurate, and if 
not, how we could address the issue in a manner that limits the burden 
on hospitals and states. We are not proposing any specific policy in 
this rule, but, if necessary, we expect to address the issue in a 
future proposed rule that is more specifically related to hospital 
payment.
4. Proposed Revisions to Stage 3 Meaningful Use Measures for Medicaid 
EPs
a. Proposed Change to Objective 6 (Coordination of Care Through Patient 
Engagement)
    In the Stage 3 final rule, we adopted a phased approach under Stage 
3 for EP Objective 6 (Coordination of care through patient engagement), 
Measure 1 (View, Download, or Transmit) and Measure 2 (Secure 
Electronic Messaging). This phased approach established a 5 percent 
threshold for both measures 1 and 2 of this objective for an EHR 
reporting period in 2017. (80 FR 62848 through 62849) In the same rule, 
we established that the threshold for Measure 1 would rise to 10 
percent, beginning with the EHR reporting period in 2018, and that the 
threshold for Measure 2 would rise to 25 percent, beginning with the 
EHR reporting period in 2018 We stated that we would continue to 
monitor performance on these measures to determine if any further 
adjustment was needed. In the FY 2018 IPPS/LTCH PPS final rule (82 FR 
38493), we established a policy allowing EPs, eligible hospitals, and 
CAHs to use either 2014 Edition or 2015 Edition CEHRT, or a combination 
of 2014 Edition and 2015 Edition CEHRT, for an EHR reporting period in 
CY 2018, and depending on which Edition(s) they use, to attest to the 
Modified Stage 2 objectives and measures or the Stage 3 objectives and 
measures. In doing so, we also delayed the rise of the Objective 6 
Measure 1 and Measure 2 thresholds until 2019.
    Based on feedback we have received, we understand that these two 
measures are the largest barrier to successfully demonstrating 
meaningful use, especially in rural areas and at safety net clinics. 
Stakeholders have reported a variety of causes that have resulted in 
lower patient participation than was anticipated when the Stage 3 final 
rule was issued. The data that we have collected via states for 
Medicaid EPs and at CMS from Medicare EPs for previous program years 
supports this feedback. The primary issue is that the view, download, 
transmit measure requires a positive action by patients, which cannot 
be controlled by an EP. Medicaid populations that are at the greatest 
risk have lower levels of internet access, internet literacy and health 
literacy than the general population. While the Secure Electronic 
Messaging measure does not require patient action, only that the EP 
send a secure message, we have received feedback that this 
functionality is not highly utilized by patients. While we encourage 
EPs to continue to reach out to patients via secure messaging to engage 
them in their health care between office visits, it is not productive 
for EPs to send messages to patients who are unlikely to see them or 
take action. Retaining the current threshold of 5 percent for both 
measures would continue to incentivize EPs to engage patients in their 
own care without raising the requirements to unattainable thresholds 
for EPs who serve vulnerable Medicaid patients. Therefore, we propose 
to amend Sec.  495.24(d)(6)(i) such that the thresholds

[[Page 35874]]

for Measure 1 (View, Download, or Transmit) and Measure 2 (Secure 
Electronic Messaging) of Meaningful Use Stage 3 EP Objective 6 
(Coordination of care through patient engagement) would remain 5 
percent for 2019 and subsequent years.
    We invite comments on this proposal.
b. Proposed Change to the Syndromic Surveillance Reporting Measure
    In the Stage 3 final rule, we established that the syndromic 
surveillance reporting measure for EPs was limited to those who 
practice in urgent care settings (80 FR 62866 through 62870). Since 
then, we have received feedback from states and public health agencies 
that while many are unable to accept non-emergency or non-urgent care 
ambulatory syndromic surveillance data electronically, some public 
health agencies can and do want to receive data from health care 
providers in non-urgent care settings. We believe that public health 
agencies that set the requirements for data submission to public health 
registries are in a better position to judge which health care 
providers can contribute useful data.
    Therefore, we propose to amend Sec.  495.24(d)(8)(i)(B)(2), EP 
Objective 8 (Public health and clinical data registry reporting), 
Measure 2 (Syndromic surveillance reporting measure), to amend the 
language restricting the use of syndromic surveillance reporting for 
meaningful use only to EPs practicing in an urgent care setting. We 
propose to include any EP defined by the state or local public health 
agency as a provider who can submit syndromic surveillance data. This 
change would not alter the exclusion for this measure at Sec.  
495.25(d)(8)(i)(C)(2)(i), for EPs who are not in a category of health 
care providers from which ambulatory syndromic surveillance data is 
collected by their jurisdiction's syndromic surveillance system, as 
defined by the state or local public health agency. Furthermore, this 
does not create any requirements for syndromic surveillance registries 
to include all EPs. Additionally, under the specifications for the 2015 
Edition of CEHRT for syndromic surveillance, it is possible that an EP 
could own CEHRT and submit syndromic surveillance in a format that is 
not accepted by the local jurisdiction. In this case, the EP may take 
an exclusion for syndromic surveillance.
    We invite comments on this proposal.

F. Medicare Shared Savings Program

    As required under section 1899 of the Act, we established the 
Medicare Shared Savings Program (Shared Savings Program) to facilitate 
coordination and cooperation among health care providers to improve the 
quality of care for Medicare Fee-For-Service (FFS) beneficiaries and 
reduce the rate of growth in expenditures under Medicare Parts A and B. 
Eligible groups of providers and suppliers, including physicians, 
hospitals, and other health care providers, may participate in the 
Shared Savings Program by forming or participating in an Accountable 
Care Organization (ACO). The final rule establishing the Shared Savings 
Program appeared in the November 2, 2011 Federal Register (Medicare 
Program; Medicare Shared Savings Program: Accountable Care 
Organizations; Final Rule (76 FR 67802) (hereinafter referred to as the 
``November 2011 final rule''). A subsequent major update to the program 
rules appeared in the June 9, 2015 Federal Register (Medicare Program; 
Medicare Shared Savings Program: Accountable Care Organizations; Final 
Rule (80 FR 32692) (hereinafter referred to as the ``June 2015 final 
rule'')). The final rule entitled, ``Medicare Program; Medicare Shared 
Savings Program; Accountable Care Organizations--Revised Benchmark 
Rebasing Methodology, Facilitating Transition to Performance-Based 
Risk, and Administrative Finality of Financial Calculations,'' which 
addressed changes related to the program's financial benchmark 
methodology, appeared in the June 10, 2016 Federal Register (81 FR 
37950) (hereinafter referred to as the ``June 2016 final rule'').
    We have also made use of the annual calendar year (CY) Physician 
Fee Schedule (PFS) rules to address quality reporting for the Shared 
Savings Program and certain other issues. In the CY 2018 PFS final rule 
(82 FR 53209 through 53226), we finalized revisions to several 
different policies under the Shared Savings Program, including the 
assignment methodology, quality measure validation audit process, use 
of the skilled nursing facility (SNF) 3-day waiver, and handling of 
demonstration payments for purposes financial reconciliation and 
establishing historical benchmarks. In addition, in the CY 2017 Quality 
Payment Program final rule (81 FR 77255 through 77260) and the CY 2018 
Quality Payment Program final rule (82 FR 53688 through 53706), we 
finalized policies related to the Alternative Payment Model (APM) 
scoring standard under the Merit-Based Incentive Payment System (MIPS), 
which reduces the reporting burden for MIPS eligible clinicians who 
participate in MIPS APMs, such as the Shared Savings Program, by: (1) 
Using the CAHPS for ACOs survey and the ACO reported CMS Web Interface 
quality data for purposes of assessing quality performance in the 
Shared Savings Program and to score the MIPS quality performance 
category for these eligible clinicians; (2) automatically awarding MIPS 
eligible clinicians participating in Shared Savings Program ACOs a 
minimum of one-half of the total points in the MIPS improvement 
activities performance category; (3) requiring ACO participants to 
report Advancing Care Information (ACI) data at the group practice 
level or solo practitioner level; and (4) not assessing MIPS eligible 
clinicians on the MIPS cost performance category because, through their 
participation in the ACO, they are already being assessed on cost and 
utilization under the Shared Savings Program.
    As a general summary, we are proposing the following changes to the 
quality performance measures that will be used to assess quality 
performance under the Shared Savings Program for performance year 2019 
and subsequent years:
     Changes to Patient Experience of Care Survey measures.
     Changes to CMS Web Interface and Claims-Based measures.
1. Quality Measurement
a. Background
    Section 1899(b)(3)(C) of the Act states that the Secretary shall 
establish quality performance standards to assess the quality of care 
furnished by ACOs and seek to improve the quality of care furnished by 
ACOs over time by specifying higher standards, new measures, or both. 
In the November 2011 final rule, we established a quality performance 
standard consisting of 33 measures across four domains, including 
patient experience of care, care coordination/patient safety, 
preventive health, and at-risk population (76 FR 67872 through 67891). 
Since the Shared Savings Program was established, we have updated the 
measures that comprise the quality performance standard for the Shared 
Savings Program through the annual rulemaking in the CY 2015, 2016, and 
2017 PFS final rules (79 FR 67907 through 67920, 80 FR 71263 through 
71268, and 81 FR 80484 through 80489, respectively).
    As we stated in the November 2011 final rule establishing the 
Shared Savings Program (76 FR 67872), our principal goal in selecting 
quality measures for ACOs has been to identify

[[Page 35875]]

measures of success in the delivery of high-quality health care at the 
individual and population levels, with a focus on outcomes.
    For performance year 2018, 31 quality measures are used to 
determine ACO quality performance (81 FR 80488 and 80489). Quality 
measures are submitted by the ACO through the CMS Web Interface, 
calculated by CMS from administrative and claims data, and collected 
via a patient experience of care survey referred to as the Consumer 
Assessment of Healthcare Provider and Systems (CAHPS) for ACOs Survey. 
The CAHPS for ACOs survey is based on the Clinician and Group Consumer 
Assessment of Healthcare Providers and Systems (CG-CAHPS) Survey and 
includes additional, program specific questions that are not part of 
the CG-CAHPS. The CG-CAHPS survey is maintained, and periodically 
updated, by the Agency for Healthcare Research and Quality (AHRQ).
    The quality measures collected through the CMS Web Interface in 
2015 and 2016 were used to determine whether eligible professionals 
participating in an ACO would avoid the PQRS and automatic Physician 
Value-Based Payment Modifier (Value Modifier) downward payment 
adjustments for 2017 and 2018 and to determine if ACO participants were 
eligible for upward, neutral or downward adjustments based on quality 
measure performance under the Value Modifier. Beginning with the 2017 
performance period, which impacts payments in 2019, PQRS and the Value 
Modifier were replaced by the MIPS. Eligible clinicians who are 
participating in an ACO and subject to MIPS (MIPS eligible clinicians) 
will be scored under the alternative payment model (APM) scoring 
standard under MIPS (81 FR 77260). These MIPS eligible clinicians 
include any eligible clinicians who are participating in an ACO in a 
track of the Shared Savings Program that is an Advanced APM, but who do 
not become Qualifying APM Participants (QPs) as specified in Sec.  
414.1425, and are not otherwise excluded from MIPS. Beginning with the 
2017 reporting period, measures collected through the CMS Web Interface 
will be used to determine the MIPS quality performance category score 
for MIPS eligible clinicians participating in a Medicare Shared Savings 
Program ACO. Starting with the 2018 performance period, the quality 
performance category under the MIPS APM Scoring Standard for MIPS 
eligible clinicians participating in a Shared Savings Program ACO will 
include measures collected through the CMS Web Interface and the CAHPS 
for ACOs survey measures.
    The CAHPS for ACOs Survey includes the core questions contained in 
the CG-CAHPS, plus additional questions to measure access to and use of 
specialist care, experience with care coordination, patient involvement 
in decision-making, experiences with a health care team, health 
promotion and patient education, patient functional status, and general 
health. From 2014 through 2017, ACOs had the option to use a short 
version of the survey (8 Summary Survey Measures (SSMs) used in 
assessing quality performance, 1 SSM scored for informational purposes) 
or a longer version of the survey (8 SSMs used in determining quality 
performance and 4 SSMs scored for informational purposes). Although not 
all measures in the longer version of the survey were used in 
determining the ACO's quality score, the measure performance rate 
information could be used by the ACO in its quality improvement 
efforts. For 2018, CMS will only offer one version of the CAHPS for 
ACOs survey. Eight SSMs will be used in quality determination and two 
SSMs will be scored for informational purposes. There were no changes 
to the scored measure set between the 2017 and 2018 surveys: The 2018 
survey is a streamlined version of the survey that assesses the same 
content areas required in 2017, using fewer survey items.
    The 2018 CAHPS for ACOs survey incorporates updates made by AHRQ to 
the Clinician and Group (CG) CAHPS survey that were based on feedback 
from survey users and stakeholders as well as analyses of multiple data 
sets. In the ``Notice of Proposed Changes for the Consumer Assessment 
of Healthcare Providers and Systems (CAHPS) Clinician & Group Survey'' 
published in the January 21, 2015 Federal Register (80 FR 2938-2939), 
AHRQ solicited public comment on proposed updates to produce the CAHPS 
Clinician & Group Survey v. 3.0. Based on analyses of multiple data 
sets and comments received from the public, AHRQ, released the CAHPS 
Clinician & Group Survey v. 3.0. The 2018 CAHPS for ACOs survey 
includes language refinements and core SSM item changes that align with 
the CAHPS Clinician & Group Survey v. 3.0.
    Additional information on the CG-CAHPS survey update is available 
on the AHRQ website at https://www.ahrq.gov/sites/default/files/wysiwyg/cahps/surveys-guidance/cg/about/proposed-changes-cahps-c&g-survey2015.pdf.
    In addition to incorporating changes based on the AHRQ survey 
update, CMS removed all items included in the SSMs, Helping You to Take 
Medications as Directed and Between Visit Communication. These were 
optional SSMs that were not part of the scored measures. The update 
resulted in reducing the number of questions from 80 to 58 questions. 
Accordingly, the CAHPS for ACOs SSMs that contribute to the ACO 
performance score for performance year 2018, as finalized in the CY 
2017 PFS final rule (81 FR 80488) are: Getting Timely Care, 
Appointments & Information; How Well Your Providers Communicate; 
Patients' Rating of Provider; Access to Specialists; Health Promotion 
and Education; Shared Decision Making; Health Status & Functional 
Status; and Stewardship of Patient Resources. In addition, the core 
survey includes SSMs on Care Coordination and Courteous & Helpful 
Office Staff. However, because these measures are not included in the 
Shared Savings Program quality measure set for 2018, scores for these 
measures will be provided to ACOs for informational purposes only and 
will not be used in determining the ACOs' quality scores.
b. Proposals for Changes to the CAHPS Measure Set
    To enhance the Patient/Caregiver Experience domain and align with 
MIPS (82 FR 54163), we are proposing to begin scoring the 2 SSMs that 
are currently collected with the administration of the CAHPS for ACOs 
survey and shared with the ACOs for informational purposes only. Under 
this proposal, we would add the following CAHPS for ACOs SSMs that are 
already collected and provided to ACOs for informational purposes to 
the quality measure set for the Shared Savings Program as ACO-45, 
CAHPS: Courteous and Helpful Office Staff, and ACO-46: CAHPS: Care 
Coordination. These measures would be scored and included in the ACO 
quality determination starting in 2019. Both of these SSMs are 
currently designated by AHRQ as CG CAHPS core measures.
    The Courteous and Helpful Office Staff SSM, which would be added as 
ACO-45, asks about the helpfulness, courtesy and respectfulness of 
office staff. This SSM has been a CG-CAHPS core measure in the previous 
two versions of the CG-CAHPS survey, but was previously provided for 
informational purposes only and not included in the ACO quality score 
determination. We are also proposing to add the SSM, CAHPS: Care 
Coordination to the CAHPS for ACOs

[[Page 35876]]

measures used in ACO quality score determination as ACO-46. The Care 
Coordination SSM asks questions about provider access to beneficiary 
information and provider follow-up. This SSM was designated a core 
measure in the most recent version of the CG-CAHPS survey.
    Inclusion of these measures in the quality measure set that is used 
to assess the quality performance of ACOs under the Shared Savings 
Program would place greater emphasis on outcome measures and the voice 
of the patient and provide ACOs with an additional incentive to act 
upon opportunities for improved care coordination and communication, 
and would align with the MIPS measure set finalized in the CY 2018 
Quality Payment Program final rule (82 FR 54163). Care Coordination and 
patient and caregiver engagement are goals of the Shared Savings 
Program. The Care Coordination SSM emphasizes the care coordination 
goal, while the Courteous and Helpful Office Staff SSM supports patient 
engagement as it addresses a topic that has been identified as 
important to beneficiaries in testing. For performance year 2016, the 
mean performance rates across all ACOs for these two measures, which 
were not included in the ACO quality score determination, were 87.18 
for the Care Coordination SSM and 92.12 for Courteous and Helpful 
Office Staff SSM.
    Consistent with Sec.  425.502(a)(4), regarding the scoring of newly 
introduced quality measures, we propose that these additional SSMs 
would be pay-for-reporting for all ACOs for 2 years (performance years 
2019 and 2020). The measures would then phase into pay-for-performance 
for ACOs in their first agreement period in the program according to 
the schedule in Table 25 beginning in performance year 2021. We seek 
comment on this proposed change to the quality measure set.
    Additionally, we seek comment on potentially converting the Health 
and Functional Status SSM (ACO-7) to pay-for-performance in the future. 
The Health and Functional Status SSM is currently pay-for-reporting for 
all years. We have not scored this measure because the scores on the 
Health and Functional Status SSM may reflect the underlying health of 
beneficiaries seen by ACO providers/suppliers as opposed to the quality 
of the care provided by the ACO. We are also considering possible 
options for enhancing collection of Health and Functional Status data. 
One option would be to change our data collection procedures to collect 
data from the same ACO assigned beneficiaries over time. This change 
could allow for measurement of changes that occurred while 
beneficiaries were receiving care from ACO providers/suppliers. We are 
seeking stakeholder feedback on this approach or other recommendations 
regarding the potential inclusion of a functional status measure in the 
assessment of ACO quality performance in the future.
c. Proposed Changes to the CMS Web Interface and Claims-Based Quality 
Measure Sets
    In developing these proposals, we considered the agency's efforts 
to streamline quality measures, reduce regulatory burden and promote 
innovation as part of the agency's Meaningful Measures initiative (See 
CMS Press Release, CMS Administrator Verma Announces New Meaningful 
Measures Initiative and Addresses Regulatory Reform; Promotes 
Innovation at LAN Summit, October 30, 2017, available at https://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2017-Press-releases-items/2017-10-30.html). Under the Meaningful Measures 
initiative, CMS has committed to assessing only those core issues that 
are most vital to providing high-quality care and improving patient 
outcomes, with the aim of focusing on outcome-based measures, reducing 
unnecessary burden on providers, and putting patients first. In 
considering the quality reporting requirements under the Shared Savings 
Program, we have also considered the quality reporting requirements 
under other initiatives, such as the MIPS and Million Hearts 
Initiative, and consulted with the measures community to ensure that 
the specifications for the measures used under the Shared Savings 
Program are up-to-date with current clinical guidelines, focus on 
outcomes over process, reflect agency and program priorities, and 
reduce reporting burden.
    Since the Shared Savings Program was first established in 2012, we 
have not only updated the quality measure set to reduce reporting 
burden, but also to focus on more meaningful, outcome-based measures. 
The most recent updates to the Shared Savings Program quality measure 
set were made in the CY 2017 PFS final rule (81 FR 80484 through 80489) 
to adopt the ACO measure recommendations made by the Core Quality 
Measures Collaborative, a multi-stakeholder group with the goal of 
aligning quality measures for reporting across public and private 
initiatives to reduce provider reporting burden. Currently, more than 
half of the 31 Shared Savings Program quality measures are outcome-
based, including:
     Patient-reported outcome measures collected through the 
CAHPS for ACOs Survey that strengthen patient and caregiver experience.
     Outcome measures supporting effective communication and 
care coordination, such as unplanned admission and readmission 
measures.
     Intermediate outcome measures that address the effective 
treatment of chronic disease, such as hemoglobin A1c control for 
patients with diabetes.
    In this rule, we are proposing to reduce the total number of 
measures in the Shared Savings Program quality measure set. These 
proposals are intended to reduce the burden on ACOs and their 
participating providers and suppliers by lowering the number of 
measures they are required to report through the CMS Web Interface and 
on which they are assessed through the use of claims data. Reducing the 
number of measures on which ACOs are measured would reduce the number 
of performance metrics that they are required to track and eliminate 
redundancies between measures that target similar populations. The 
proposed reduction in the number of measures would enable ACOs to 
better utilize their resources toward improving patient care. These 
proposals further reduce burden by aligning with the proposed changes 
to the CMS Web Interface measures that are reported under MIPS as 
discussed in Tables A, C, and D of Appendix 1: Proposed MIPS Quality 
Measures of this proposed rule. We recognize that ACOs and their 
participating providers and suppliers dedicate resources to performing 
well on our quality metrics, and we believe that reducing the number of 
metrics and aligning them across programs would allow them to more 
effectively target those resources toward improving patient care. We 
are proposing to reduce the number of measures by minimizing measure 
overlap and eliminating several process measures. The proposal to 
remove process measures also aligns with our proposal to reduce the 
number of process measures within the MIPS measure set as discussed in 
section III.H.b.iii of this proposed rule and would support the CMS 
goal of moving toward outcome-based measurement.
    We are proposing to retire the following claims-based quality 
measures, which have a high degree of overlap with other measures that 
would remain in the measure set:
     ACO-35--Skilled Nursing Facility 30-Day All-Cause 
Readmission Measure (SNFRM).
     ACO-36--All-Cause Unplanned Admissions for Patients with 
Diabetes.

[[Page 35877]]

     ACO-37--All-Cause Unplanned Admission for Patients with 
Heart Failure.
    Within the claims-based quality measures, overlap exists between 
measures with respect to the population being measured (the 
denominator), because a single admission may be counted in the 
numerator for multiple measures. For example, ACO-35 addresses 
unplanned readmissions from a SNF, and the vast majority of these SNF 
readmissions are also captured in the numerator of ACO-8 Risk-
Standardized All Condition Readmission. Similarly, ACO-36 and ACO-37 
address unplanned admissions for patients with diabetes and heart 
failure and most of these admissions are captured in the numerator of 
ACO-38 Risk-Standardized Acute Admission Rates for Patients with 
Multiple Chronic Conditions (please note that the measure name has been 
updated to align with changes made by the measure steward). Therefore, 
to reduce redundancies within the Shared Savings Program measure set, 
we propose to remove ACO-35, ACO-36, and ACO-37 from the measure set. 
However, because these measures are claims-based measures and therefore 
do not impose any reporting burden on ACOs, we intend to continue to 
provide information to ACOs on their performance on these measures for 
use in their quality improvement activities through a new quarterly 
claims-based quality outcome report that ACOs will begin receiving in 
2018.
    Although we are proposing to retire ACO-35 (SNFRM) from the set of 
quality measures that are scored for the Shared Savings Program, we 
recognize the value of measuring the quality of care furnished to 
Medicare beneficiaries in SNFs. Therefore, we are seeking comment on 
the possibility of adding the Skilled Nursing Facility Quality 
Reporting Program (SNFQRP) measure ``Potentially Preventable 30-Day 
Post-Discharge Readmission Measure for Skilled Nursing Facilities'' to 
the Shared Savings Program quality measure set through future 
rulemaking. This measure differs from ACO-35 (Skilled Nursing Facility 
30-Day All-Cause Readmission Measure), which we are proposing to remove 
above, as the SNFQRP measure looks only at unplanned, potentially 
preventable readmissions for Medicare Fee-For-Service beneficiaries 
within 30 days of discharge to a lower level of care from a SNF, while 
ACO-35 assesses readmissions from a SNF, regardless of cause, that 
occur within 30 days following discharge from a hospital. As a result, 
the SNFQRP measure would have less overlap with ACO-8 (Risk-
Standardized All Cause Readmission measure) than does ACO-35 (SNFRM), 
because the two measures' readmission windows differ. Specifically, the 
readmission window for the SNFQRP measure is 30 days following 
discharge from a SNF, while the readmission window for ACO-8 is 30 days 
following discharge from a hospital.
    We are also proposing to retire claims-based measure ACO-44 (Use of 
Imaging Studies for Low Back Pain), as this measure is restricted to 
individuals 18-50 years of age, which results in low denominator rates 
under the Shared Savings Program, meaning that the measure is not a 
valuable reflection of the beneficiaries cared for by Shared Savings 
Program ACOs. As a result, although this measure was originally added 
to the Shared Savings Program quality measure set in order to align 
with the Core Quality Measures Collaborative, we no longer believe ACO-
44 is a meaningful measure that should be retained in the Shared 
Savings Program quality measure set. The deletion of this measure would 
also align ACO quality measurement with the MIPS requirements as this 
measure was removed for purposes of reporting under the MIPS program in 
the CY 2018 Quality Payment Program final rule (82 FR 54159). However, 
in recognition of the value in providing feedback to providers on 
potential overuse of diagnostic procedures, we intend to continue to 
provide ACOs feedback on performance on this measure as part of the new 
quarterly claims based quality report.
    We welcome public comment on our proposal to retire these 4 claims-
based measures from the quality measure set.
    Further, we seek to align with changes made to the CMS Web 
Interface measures under the Quality Payment Program. In the 2017 PFS 
final rule, we stated we do not believe it is beneficial to propose CMS 
Web interface measures for ACO quality reporting separately (81 FR 
80499). Therefore, in order to avoid confusion and duplicative 
rulemaking, we adopted a policy that any future changes to the CMS Web 
interface measures would be proposed and finalized through rulemaking 
for the Quality Payment Program, and that such changes would be 
applicable to ACO quality reporting under the Shared Savings Program. 
In accordance with the policy adopted in the CY 2017 PFS final rule (81 
FR 80501), we are not making any specific proposals related to changes 
in CMS Web Interface measures reported under the Shared Savings 
Program. Rather, we refer readers to Tables A, C, and D of Appendix 1: 
Proposed MIPS Quality Measures of this proposed rule for a complete 
discussion of the proposed changes to the CMS Web Interface measures. 
If the proposed changes are finalized, ACOs would no longer be 
responsible for reporting the following measures for purposes of the 
Shared Savings Program starting with reporting for performance year 
2019:
     ACO-12 (NQF #0097) Medication Reconciliation Post-
Discharge.
     ACO-13 (NQF #0101) Falls: Screening for Future Fall Risk.
     ACO-15 (NQF #0043) Pneumonia Vaccination Status for Older 
Adults.
     ACO-16 (NQF #0421) Preventive Care and Screening: Body 
Mass Index (BMI) Screening and Follow Up.
     ACO-41 (NQF #0055) Diabetes: Eye Exam.
     ACO-30 (NQF #0068) Ischemic Vascular Disease (IVD): Use of 
Aspirin or another Antithrombotic.
    We note that ACO-41 is one measure within a two-component diabetes 
composite that is currently scored as one measure. The proposed removal 
of ACO-41 means that ACO-27 Diabetes Hemoglobin A1c (HbA1c) Poor 
Control (>9%) would now be assessed as an individual measure. If the 
proposed changes are finalized as proposed, Table 26 shows the maximum 
possible points that may be earned by an ACO in each domain and overall 
in performance year 2019 and in subsequent performance years.
    Additionally, we note that we are proposing to add the following 
measure to the CMS Web Interface for purposes of the Quality Payment 
Program:
     ACO-47 (NQF #0101) Falls: Screening, Risk-Assessment, and 
Plan of Care to Prevent Future Falls.
    If this proposal is finalized, consistent with our policy of 
adopting changes to the CMS Web Interface Measures through rulemaking 
for the Quality Payment Program, Shared Savings Program ACOs would be 
responsible for reporting this measure starting in performance year 
2019.
    Table 25 shows the proposed Shared Savings Program quality measure 
set for performance year 2019 and subsequent performance years.

[[Page 35878]]



   Table 25--Proposed Measure Set for Use in Establishing the Shared Savings Program Quality Performance Standard, Starting With Performance Year 2019
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                               Pay for performance phase-
                                                                                                                                  in R--Reporting P--
             Domain               ACO  measure     Measure title     New measure   NQF #/measure steward     Method of data           Performance
                                      No.                                                                      submission     --------------------------
                                                                                                                                 PY1      PY2      PY3
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            AIM: Better Care for Individuals
--------------------------------------------------------------------------------------------------------------------------------------------------------
Patient/Caregiver Experience...  ACO-1          CAHPS: Getting      ............  NQF N/A AHRQ             Survey............       R        P        P
                                                 Timely Care,
                                                 Appointments, and
                                                 Information.
                                 ACO-2          CAHPS: How Well     ............  NQF N/A AHRQ             Survey............       R        P        P
                                                 Your Providers
                                                 Communicate.
                                 ACO-3          CAHPS: Patients'    ............  NQF N/A AHRQ             Survey............       R        P        P
                                                 Rating of
                                                 Provider.
                                 ACO-4          CAHPS: Access to    ............  NQF #N/A CMS/AHRQ        Survey............       R        P        P
                                                 Specialists.
                                 ACO-5          CAHPS: Health       ............  NQF #N/A AHRQ            Survey............       R        P        P
                                                 Promotion and
                                                 Education.
                                 ACO-6          CAHPS: Shared       ............  NQF #N/A AHRQ            Survey............       R        P        P
                                                 Decision Making.
                                 ACO-7          CAHPS: Health       ............  NQF #N/A AHRQ            Survey............       R        R        R
                                                 Status/Functional
                                                 Status.
                                 ACO-34         CAHPS: Stewardship  ............  NQF #N/A AHRQ            Survey............       R        P        P
                                                 of Patient
                                                 Resources.
                                 ACO-45         CAHPS: Courteous          \1\ X   NQF #N/A AHRQ            Survey............       R        R        P
                                                 and Helpful
                                                 Office Staff.
                                 ACO-46         CAHPS: Care               \1\ X   NQF #N/A AHRQ            Survey............       R        R        P
                                                 Coordination.
Care Coordination/Patient        ACO-8          Risk-Standardized,  ............  Adapted NQF #1789 CMS    Claims............       R        R        P
 Safety.                                         All Condition
                                                 Readmission.
                                 ACO-38         Risk-Standardized   ............  NQF#2888 CMS             Claims............       R        R        P
                                                 Acute Admission
                                                 Rates for
                                                 Patients with
                                                 Multiple Chronic
                                                 Conditions.
                                 ACO-43         Ambulatory          ............  AHRQ                     Claims............       R        P        P
                                                 Sensitive
                                                 Condition Acute
                                                 Composite (AHRQ
                                                 Prevention
                                                 Quality Indicator
                                                 (PQI) #91)
                                                 (version with
                                                 additional Risk
                                                 Adjustment) \2\.
                                 ACO-47         Falls: Screening,   ............  NQF #0101 NCQA           CMS Web Interface.       R        R        P
                                                 Risk-Assessment,
                                                 and Plan of Care
                                                 to Prevent Future
                                                 Falls.
                                 ACO-11         Use of certified    ............  NQF #N/A CMS             Quality Payment          R        P        P
                                                 EHR technology.                                            Program Advancing
                                                                                                            Care Information.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                           AIM: Better Health for Populations
--------------------------------------------------------------------------------------------------------------------------------------------------------
Preventive Health..............  ACO-14         Preventive Care     ............  NQF #0041 AMA-PCPI       CMS Web Interface.       R        P        P
                                                 and Screening:
                                                 Influenza
                                                 Immunization.
                                 ACO-17         Preventive Care     ............  NQF #0028 AMA-PCPI       CMS Web Interface.       R        P        P
                                                 and Screening:
                                                 Tobacco Use:
                                                 Screening and
                                                 Cessation
                                                 Intervention.
                                 ACO-18         Preventive Care     ............  NQF #0418 CMS            CMS Web Interface.       R        P        P
                                                 and Screening:
                                                 Screening for
                                                 Depression and
                                                 Follow-up Plan.
                                 ACO-19         Colorectal Cancer   ............  NQF #0034 NCQA           CMS Web Interface.       R        R        P
                                                 Screening.
                                 ACO-20         Breast Cancer       ............  NQF #2372 NCQA           CMS Web Interface.       R        R        P
                                                 Screening.
                                 ACO-42         Statin Therapy for  ............  NQF #N/A CMS             CMS Web Interface.       R        R        R
                                                 the Prevention
                                                 and Treatment of
                                                 Cardiovascular
                                                 Disease.
Clinical Care for At Risk        ACO-40         Depression          ............  NQF #0710 MNCM           CMS Web Interface.       R        R        R
 Population--Depression.                         Remission at
                                                 Twelve Months.
Clinical Care for At Risk        ACO-27         Diabetes            ............  NQF #0059 NCQA           CMS Web Interface.       R        P        P
 Population--Diabetes.                           Hemoglobin A1c
                                                 (HbA1c) Poor
                                                 Control (>9%).
Clinical Care for At Risk        ACO-28         Hypertension :      ............  NQF #0018 NCQA           CMS Web Interface.       R        P        P
 Population--Hypertension.                       Controlling High
                                                 Blood Pressure.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Measures that are currently collected as part of the administration of the CAHPS for ACO survey, but will be considered new measures for purposes of
  the pay for performance phase-in.
\2\ The language in parentheses has been added for clarity and no changes have been made to the measure.

    We are proposing to eliminate 10 measures and to add one measure to 
the Shared Savings Program quality measure set. This would result in 24 
measures for which ACOs would be held accountable. With these proposed 
measure changes, the 4 domains would include the following numbers of 
quality measures (See Table 26):
     Patient/Caregiver Experience of Care--10 measures.
     Care Coordination/Patient Safety--5 measures, including 
the double-weighted EHR measure (ACO-11).
     Preventive Health--6 measures.
     At Risk Populations--3 measures.
    Table 26 provides a summary of the number of measures by domain and 
the total points and domain weights that would be used for scoring 
purposes under the changes to the quality measure set proposed in this 
proposed rule.

[[Page 35879]]



     Table 26--Number of Measures and Total Points for Each Domain Within the Shared Savings Program Quality
                            Performance Standard, Starting With Performance Year 2019
----------------------------------------------------------------------------------------------------------------
                                           Number of
                Domain                    individual       Total measures for     Total possible   Domain weight
                                           measures         scoring purposes          points            (%)
----------------------------------------------------------------------------------------------------------------
Patient/Caregiver Experience..........              10  10 individual survey                  20              25
                                                         module measures.
Care Coordination/Patient Safety......               5  5 measures, including                 12              25
                                                         double-weighted EHR
                                                         measure.
Preventive Health.....................               6  6 measures..............              12              25
At-Risk Population....................               3  3 individual measures...               6              25
                                       -------------------------------------------------------------------------
    Total in all Domains..............              24  24......................              50             100
----------------------------------------------------------------------------------------------------------------

G. Physician Self-Referral Law

1. Background
    Section 1877 of the Act, also known as the physician self-referral 
law: (1) Prohibits a physician from making referrals for certain 
designated health services (DHS) payable by Medicare to an entity with 
which he or she (or an immediate family member) has a financial 
relationship (ownership or compensation), unless an exception applies; 
and (2) prohibits the entity from filing claims with Medicare (or 
billing another individual, entity, or third party payer) for those 
referred services. The statute establishes a number of specific 
exceptions, and grants the Secretary the authority to create regulatory 
exceptions for financial relationships that pose no risk of program or 
patient abuse. Additionally, the statute mandates refunding any amount 
collected under a bill for an item or service furnished under a 
prohibited referral. Finally, the statute imposes reporting 
requirements and provides for sanctions, including civil monetary 
penalty provisions.
    Section 50404 of the Bipartisan Budget Act of 2018 (Pub. L. 115-
123, enacted February 9, 2018) added provisions to section 1877(h)(1) 
of the Act pertaining to the writing and signature requirements in 
certain compensation arrangement exceptions to the statute's referral 
and billing prohibitions. Although we believe that the newly enacted 
provisions in section 1877(h)(1) of the Act are principally intended 
merely to codify in statute existing CMS policy and regulations with 
respect to compliance with the writing and signature requirements, we 
are proposing revisions to our regulations to address any actual or 
perceived difference between the statutory and regulatory language, to 
codify in regulation our longstanding policy regarding satisfaction of 
the writing requirement found in many of the exceptions to the 
physician self-referral law, and to make the Bipartisan Budget Act of 
2018 policies applicable to compensation arrangement exceptions issued 
using the Secretary's authority in section 1877(b)(4) of the Act.
    In the CY 2016 PFS final rule with comment period (80 FR 70885), we 
revised Sec.  411.357(a)(7), (b)(6), and (d)(1)(vii) to permit a lease 
arrangement or personal service arrangement to continue indefinitely 
beyond the stated expiration of the written documentation describing 
the arrangement under certain circumstances. Section 50404 of the 
Bipartisan Budget Act of 2018 added substantively identical holdover 
provisions to section 1877(e) of the Act. Because the new statutory 
holdover provisions effectively mirror the existing regulatory 
provisions, we do not believe it is necessary to revise Sec.  
411.357(a)(7), (b)(6), and (d)(1)(vii) as a result of these statutory 
revisions.
2. Special Rules on Compensation Arrangements (Section 1877(h)(1)(E) of 
the Act)
    Many of the exceptions for compensation arrangements in Sec.  
411.357 require that the arrangements are set out in writing and signed 
by the parties. (See Sec.  411.357(a)(1), (b)(1), (d)(1)(i), (e)(1)(i), 
(e)(4)(i), (l)(1), (p)(2), (q) (incorporating the requirement contained 
in Sec.  1001.952(f)(4)), (r)(2)(ii), (t)(1)(ii) or (t)(2)(iii) (both 
incorporating the requirements contained in Sec.  411.357(e)(1)(i)), 
(v)(7), (w)(7), (x)(1)(i), and (y)(1).) \7\ As described above, section 
50404 of the Bipartisan Budget Act of 2018 amended section 1877 of the 
Act with respect to the writing and signature requirements in the 
statutory compensation arrangement exceptions. As detailed below, we 
are proposing a new special rule on compensation arrangements at Sec.  
411.354(e) and proposing to amend existing Sec.  411.353(g) to codify 
the statutory provisions in our regulations.
---------------------------------------------------------------------------

    \7\ We note that, where the writing requirement appears in the 
statutory and regulatory exceptions, we interpret it uniformly, 
regardless of any minor differences in the language of the 
requirement. See 80 FR 71315. Similarly, we interpret the signature 
requirement uniformly where it appears, regardless of any minor 
differences in the language of the statutory and regulatory 
exceptions.
---------------------------------------------------------------------------

a. Writing Requirement (Sec.  411.354(e))
    In the CY 2016 PFS final rule with comment period, we stated CMS' 
longstanding policy that the writing requirement in various 
compensation arrangement exceptions in Sec.  411.357 can be satisfied 
by ``a collection of documents, including contemporaneous documents 
evidencing the course of conduct between the parties'' (80 FR 71315). 
Our guidance on the writing requirement appeared in the preamble of the 
CY 2016 PFS final rule with comment period but was not codified in 
regulations. Section 50404 of the Bipartisan Budget Act of 2018 added 
subparagraph D, ``Written Requirement Clarified,'' to section 
1877(h)(1) of the Act. Section 1877(h)(1)(D) of the Act provides that, 
in the case of any requirement in section 1877 of the Act for a 
compensation arrangement to be in writing, such requirement shall be 
satisfied by such means as determined by the Secretary, including by a 
collection of documents, including contemporaneous documents evidencing 
the course of conduct between the parties involved.
    In light of the recently added statutory provision at section 
1877(h)(1)(D) of the Act, we are proposing to add a special rule on 
compensation arrangements at Sec.  411.354(e). Proposed Sec.  
411.354(e) provides that, in the case of any requirement in 42 CFR part 
411, subpart J, for a compensation arrangement to be in writing, the 
writing requirement may be satisfied by a collection of documents, 
including contemporaneous documents evidencing the course of conduct 
between the parties. The special rule at Sec.  411.357(e) codifies our 
existing policy on the writing requirement, as previously articulated 
in the CY 2016 PFS final rule with comment period. (See 80 FR 71314 et 
seq.)

[[Page 35880]]

b. Special Rule for Certain Arrangements Involving Temporary 
Noncompliance With Signature Requirements (Sec.  411.353(g))
    Many of the exceptions for compensation arrangements in Sec.  
411.357 require that the arrangement (that is, the written 
documentation evidencing the arrangement) is signed by the parties to 
the arrangement. Under our existing special rule for certain 
arrangements involving temporary noncompliance with signature 
requirements at Sec.  411.353(g)(1), an entity that has a compensation 
arrangement with a physician that satisfies all the requirements of an 
applicable exception in Sec.  411.355, Sec.  411.356 or Sec.  411.357 
except the signature requirement may submit a claim and receive payment 
for a designated health service referred by the physician, provided 
that: (1) The parties obtain the required signature(s) within 90 
consecutive calendar days immediately following the date on which the 
compensation arrangement became noncompliant (without regard to whether 
any referrals occur or compensation is paid during such 90-day period); 
and (2) the compensation arrangement otherwise complies with all 
criteria of the applicable exception. Existing Sec.  411.353(g)(1) 
specifies the paragraphs where the applicable signature requirements 
are found and existing Sec.  411.353(g)(2) limits an entity's use of 
the special rule at Sec.  411.353(g)(1) to only once every 3 years with 
respect to the same referring physician.
    Section 50404 of the Bipartisan Budget Act of 2018 added 
subparagraph E, ``Signature Requirement,'' to section 1877(h)(1) of the 
Act. Section 1877(h)(1)(E) of the Act provides that, in the case of any 
requirement in section 1877 of the Act for a compensation arrangement 
to be in writing and signed by the parties, the signature requirement 
is satisfied if: (1) Not later than 90 consecutive calendar days 
immediately following the date on which the compensation arrangement 
became noncompliant, the parties obtain the required signatures; and 
(2) the compensation arrangement otherwise complies with all criteria 
of the applicable exception. Notably, under the newly added section 
1877(h)(1)(E) of the Act, an applicable signature requirement is not 
limited to specific exceptions and entities are not limited in their 
use of the rule to only once every 3 years with respect to the same 
referring physician. In addition, section 1877(h)(1)(E) of the Act does 
not include a reference to the occurrence of referrals or the payment 
of compensation during the 90-day period when the signature requirement 
is not met.
    To conform the regulations with the recently added statutory 
provision at section 1877(h)(1)(E) of the Act, we are proposing to 
amend existing Sec.  411.353(g) by: (1) Revising the reference at Sec.  
411.353(g)(1) to specific exceptions and signature requirements; (2) 
deleting the reference at Sec.  411.353(g)(1) to the occurrence of 
referrals or the payment of compensation during the 90-day period when 
the signature requirement is not met; and (3) deleting the limitation 
at Sec.  411.353(g)(2). In the alternative, we are proposing to delete 
Sec.  411.353(g) in its entirety and codify in proposed Sec.  
411.354(e) the special rule for signature requirements in section 
1877(h)(1)(E). We seek comments regarding the best approach for 
codifying in regulation this provision of the Bipartisan Budget Act of 
2018.
    Finally, we note that the effective date of section 50404 of the 
Bipartisan Budget Act was February 9, 2018. Thus, beginning February 9, 
2018, parties who meet the requirements of section 1877(h)(1)(E) of the 
Act, including parties who otherwise would have been barred from 
relying on the special rule for certain arrangements involving 
temporary noncompliance with signature requirements at Sec.  
411.353(g)(1) because of the 3-year limitation at Sec.  411.353(g)(2), 
may avail themselves of the new statutory provision at section 
1877(h)(1)(E) of the Act.

H. CY 2019 Updates to the Quality Payment Program

1. Executive Summary
a. Overview
    This proposed rule would make payment and policy changes to the 
Quality Payment Program. The Medicare Access and CHIP Reauthorization 
Act of 2015 (MACRA) (Pub. L. 114-10, enacted April 16, 2015) amended 
title XVIII of the Act to repeal the Medicare sustainable growth rate 
(SGR) formula, to reauthorize the Children's Health Insurance Program, 
and to strengthen Medicare access by improving physician and other 
clinician payments and making other improvements. The MACRA advances a 
forward-looking, coordinated framework for clinicians to successfully 
take part in the Quality Payment Program that rewards value in one of 
two ways:
     The Merit-based Incentive Payment System (MIPS).
     Advanced Alternative Payment Models (Advanced APMs).
    As we move into the third year of the Quality Payment Program, we 
have taken all stakeholder input into consideration including 
recommendations made by the Medicare Payment Advisory Commission 
(MedPAC), an independent congressional agency established by the 
Balanced Budget Act of 1997 (Pub. L. 105-33) to advise the U.S. 
Congress on issues affecting the Medicare program, including payment 
policies under Medicare, the factors affecting expenditures for the 
efficient provision of services, and the relationship of payment 
policies to access and quality of care for Medicare beneficiaries. We 
will continue to implement the Quality Payment Program as required, 
smoothing the transition where possible and offering targeted 
educational resources for program participants. A few examples of how 
we are working to address MedPAC's concerns are evident in our work 
around burden reduction and reshaping our focus of interoperability. 
Additionally, we heard the concern about process-based measures, and we 
are continuing to move towards the development and use of more outcome 
measures by way of removing process measures that are topped out and 
funding new quality measure development, as required by section 102 of 
MACRA. Additionally, we are also developing new episode-based cost 
measures, with stakeholder feedback, for potential inclusion in the 
cost performance category beginning in 2019. CMS acknowledges that the 
Quality Payment Program is a large shift for many clinicians and 
practices, and thus, we will continue to implement the program 
gradually with targeted educational resources, public trainings, and 
technical assistance for those who qualify. With MIPS, eligible 
clinicians now report under one program, which replaces three separate 
legacy programs. The Quality Payment Program takes a comprehensive 
approach to payment. Instead of basing payment only on a series of fee-
for-service billing codes, the Quality Payment Program adds 
consideration of quality through a set of evidence-based measures and 
clinical practice improvement activities that were primarily developed 
by clinicians.
    As a priority for Quality Payment Program Year 3, we are committed 
to reducing clinician burden, implementing the Meaningful Measures 
Initiative, promoting interoperability, continuing our support of small 
and rural practices, empowering patients through the Patients Over 
Paperwork initiative, and promoting price transparency.

[[Page 35881]]

Reducing Clinician Burden
    We are committed to reducing clinician burden by simplifying and 
reducing burden for participating clinicians. Examples include:
     Implementing the Meaningful Measures Initiative, which is 
a framework that applies a series of cross-cutting criteria to keep the 
most meaningful measures with the least amount of burden and greatest 
impact on patient outcomes;
     Promoting advances in interoperability; and
     Establishing an automatic extreme and uncontrollable 
circumstances policy for MIPS eligible clinicians.
Improving Patient Outcomes and Reducing Burden Through Meaningful 
Measures
    Regulatory reform and reducing regulatory burden are high 
priorities for us. To reduce the regulatory burden on the healthcare 
industry, lower health care costs, and enhance patient care, in October 
2017, we launched the Meaningful Measures Initiative.\8\ This 
initiative is one component of our agency-wide Patients Over Paperwork 
Initiative,\9\ which is aimed at evaluating and streamlining 
regulations with a goal to reduce unnecessary cost and burden, increase 
efficiencies, and improve beneficiary experience. The Meaningful 
Measures Initiative is aimed at identifying the highest priority areas 
for quality measurement and quality improvement to assess the core 
quality of care issues that are most vital to advancing our work to 
improve patient outcomes. The Meaningful Measures Initiative represents 
a new approach to quality measures that fosters operational 
efficiencies and will reduce costs, including the collection and 
reporting burden, while producing quality measurement that is more 
focused on meaningful outcomes.
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    \8\ Meaningful Measures web page: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/MMF/General-info-Sub-Page.html.
    \9\ See Remarks by Administrator Seema Verma at the Health Care 
Payment Learning and Action Network (LAN) Fall Summit, as prepared 
for delivery on October 30, 2017, https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2017-Fact-Sheet-items/2017-10-30.html.
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    The Meaningful Measures Framework has the following objectives:
     Address high-impact measure areas that safeguard public 
health;
     Patient-centered and meaningful to patients;
     Outcome-based where possible;
     Fulfill each program's statutory requirements;
     Minimize the level of burden for health care providers 
(for example, through a preference for EHR-based measures where 
possible, such as electronic clinical quality measures);
     Significant opportunity for improvement;
     Address measure needs for population based payment through 
alternative payment models; and
     Align across programs and/or with other payers.
    To achieve these objectives, we have identified 19 Meaningful 
Measures areas and mapped them to six overarching quality priorities as 
shown in Table 27.

    Table 27--Meaningful Measures Framework Domains and Measure Areas
------------------------------------------------------------------------
            Quality priority                 Meaningful measure area
------------------------------------------------------------------------
Making Care Safer by Reducing Harm       Healthcare-Associated
 Caused in the Delivery of Care.          Infections.
                                         Preventable Healthcare Harm.
Strengthen Person and Family Engagement  Care is Personalized and
 as Partners in Their Care.               Aligned with Patient's Goals.
                                         End of Life Care according to
                                          Preferences.
                                         Patient's Experience of Care.
                                         Patient Reported Functional
                                          Outcomes.
Promote Effective Communication and      Medication Management.
 Coordination of Care.                   Admissions and Readmissions to
                                          Hospitals.
                                         Transfer of Health Information
                                          and Interoperability.
Promote Effective Prevention and         Preventive Care.
 Treatment of Chronic Disease.           Management of Chronic
                                          Conditions.
                                         Prevention, Treatment, and
                                          Management of Mental Health.
                                         Prevention and Treatment of
                                          Opioid and Substance Use
                                          Disorders.
                                         Risk Adjusted Mortality.
Work with Communities to Promote Best    Equity of Care.
 Practices of Healthy Living.            Community Engagement.
Make Care Affordable...................  Appropriate Use of Healthcare.
                                         Patient-focused Episode of
                                          Care.
                                         Risk Adjusted Total Cost of
                                          Care.
------------------------------------------------------------------------

    By including Meaningful Measures in our programs, we believe that 
we can also address the following cross-cutting measure criteria:
     Eliminating disparities;
     Tracking measurable outcomes and impact;
     Safeguarding public health;
     Achieving cost savings;
     Improving access for rural communities; and
     Reducing burden.
    We believe that the Meaningful Measures Initiative will improve 
outcomes for patients, their families, and health care providers while 
reducing burden and costs for clinicians and providers and promoting 
operational efficiencies.
    In the quality performance category, clinicians have the 
flexibility to select and report the measures that matter most to their 
practice and patients. However, we have received feedback that some 
clinicians find the performance requirements confusing, and the program 
makes it difficult for them to choose measures that are meaningful to 
their practices and have more direct benefit to beneficiaries. For the 
2019 MIPS performance period, we are proposing the following updates: 
(1) Adding 10 new MIPS quality measures that include 4 patient reported 
outcome measures, 7 high priority measures, 1 measure that replaces an 
existing measure, and 2 other measures on important clinical topics in 
the Meaningful Measures framework; and (2) removing 34 quality 
measures.
    In addition to having the right measures, we want to ensure that 
the collection of information is valuable to clinicians and worth the 
cost and burden of collecting the information. In

[[Page 35882]]

section III.H.3.h.(2)(b)(iv) of this proposed rule, we are requesting 
comments on a tiered scoring system for quality measures where measures 
would be awarded points based on their value. We are also seeking 
comment on what patient reported outcome measures produce better 
outcomes and request accompanying supporting evidence that the measures 
do, in fact, improve outcomes.
Promoting Interoperability Performance Category
    As required by MACRA, the Quality Payment Program includes a MIPS 
performance category that focuses on meaningful use of certified EHR 
technology, referred to in the CY 2017 and CY 2018 Quality Payment 
Program rules as the ``advancing care information'' performance 
category. As part of our approach to promoting and prioritizing 
interoperability of healthcare data, in Quality Payment Program Year 2, 
we changed the name of the performance category to the Promoting 
Interoperability performance category.
    We have prioritized interoperability, which we define as health 
information technology that enables the secure exchange of electronic 
health information with, and use of electronic health information from, 
other health information technology without special effort on the part 
of the user; allows for complete access, exchange, and use of all 
electronically accessible health information for authorized use under 
applicable law; and does not constitute information blocking as defined 
by the 21st Century Cures Act (Pub. L. 114-255, enacted December 13, 
2016). We are committed to working with the Office of the National 
Coordinator for Health IT (ONC) on implementation of the 
interoperability provisions of the 21st Century Cures Act to have 
seamless but secure exchange of health information for clinicians and 
patients, ultimately enabling Medicare beneficiaries to get their 
claims information electronically. In addition, we are prioritizing 
quality measures and improvement activities that lead to 
interoperability.
    To further CMS' commitment to implementing interoperability, at the 
2018 Healthcare Information and Management Systems Society (HIMSS) 
conference, CMS Administrator Seema Verma announced the launching of 
the MyHealthEData initiative.\10\ This initiative aims to empower 
patients by ensuring that they control their healthcare data and can 
decide how their data is going to be used, all while keeping that 
information safe and secure. The overall government-wide initiative is 
led by the White House Office of American Innovation with participation 
from HHS--including its CMS, ONC, and the National Institutes of Health 
(NIH)--as well as the U.S. Department of Veterans Affairs (VA). 
MyHealthEData aims to break down the barriers that prevent patients 
from having electronic access and true control of their own health 
records from the device or application of their choice. This effort 
will approach the issue of healthcare data from the patient's 
perspective.
---------------------------------------------------------------------------

    \10\ https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2018-Fact-sheets-items/2018-03-06.html.
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    For the Promoting Interoperability performance category, we require 
MIPS eligible clinicians to use 2015 Edition certified EHR technology 
beginning with the 2019 MIPS performance period to make it easier for:
     Patients to access their data.
     Patient information to be shared between doctors and other 
health care providers.
Continuing To Support Small and Rural Practices
    We understand that the Quality Payment Program is a big change for 
clinicians, especially for those in small and rural practices. We 
intend to continue to offer tailored flexibilities to help these 
clinicians to participate in the program. For example, we propose to 
retain a small practice bonus under MIPS by moving it to the quality 
performance category. We will also continue to support small and rural 
practices by offering free and customized resources available within 
local communities, including direct, one-on-one support from the Small, 
Underserved, and Rural Support Initiative along with our other no-cost 
technical assistance.
    Further, we note that we are proposing to amend our regulatory text 
to allow small practices to continue using the Medicare Part B claims 
collection type. We are also proposing to revise the regulatory text to 
allow a small practice to submit quality data for covered professional 
services through the Medicare Part B claims submission type for the 
quality performance category, as discussed further in section 
III.H.3.h. of this proposed rule. Finally, small practices may continue 
to choose to participate in MIPS as a virtual group, as discussed in 
section III.H.3. of this proposed rule.
Empowering Patients Through the Patients Over Paperwork Initiative
    Our Patients Over Paperwork initiative establishes an internal 
process to evaluate and streamline regulations with a goal to reduce 
unnecessary burden, to increase efficiencies, and to improve the 
beneficiary experience.\11\ This administration is dedicated to putting 
patients first, empowering consumers of healthcare to have the 
information they need to be engaged and active decision-makers in their 
care. As a result of this consumer empowerment, clinicians will gain 
competitive advantage by delivering coordinated, high-value quality 
care.
---------------------------------------------------------------------------

    \11\ Patients Over Paperwork web page available at https://www.cms.gov/Outreach-and-Education/Outreach/Partnerships/PatientsOverPaperwork.html.
---------------------------------------------------------------------------

    The proposals for the Quality Payment Program in this proposed rule 
seek to promote competition and to empower patients. We are 
consistently listening, and we are committed to using data-driven 
insights, increasingly aligned and meaningful quality measures, and 
technology that empowers patients and clinicians to make decisions 
about their healthcare.
    In conjunction with development of the Patients Over Paperwork 
initiative, we are making progress toward developing a patient-centered 
portfolio of measures for the Quality Payment Program, including 7 new 
outcome measures included on the 2017 CMS Measures Under Consideration 
List,\12\ 5 of which are directly applicable to the prioritized 
specialties of general medicine/crosscutting and orthopedic surgery. 
Finally, on March 2, 2018, CMS announced a funding opportunity for $30 
million in grants to be awarded for quality measure development. The 
funding opportunity is aimed at external stakeholders with insight into 
clinician and patient perspectives on quality measurement and areas for 
improvement to advance quality measures for the Quality Payment 
Program.\13\
---------------------------------------------------------------------------

    \12\ Centers for Medicare & Medicaid Services. List of Measures 
Under Consideration for December 1, 2017. Baltimore, MD: US 
Department of Health and Human Services; 2017. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityMeasures/Downloads/Measures-under-Consideration-Listfor2017.pdf. Accessed May 4, 2018.
    \13\ Centers for Medicare & Medicaid Services. Medicare Access 
and CHIP Reauthorization Act of 2015 (MACRA) Funding Opportunity: 
Measure Development for the Quality Payment Program. Baltimore, MD: 
US Department of Health and Human Services; 2018. https://blog.cms.gov/2018/03/02/medicare-access-and-chipreauthorization-act-of-2015-macra-funding-opportunity/. Accessed May 4, 2018.

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[[Page 35883]]

Promoting Price Transparency
    Through the Executive Order Promoting Healthcare Choice and 
Competition Across the United States (E.O. 13813, 82 FR 48385 (Oct. 12, 
2017)), the President prioritized changing the rate of growth of 
healthcare spending to foster competition in healthcare markets, 
resulting in the American people receiving better value for their 
investment in healthcare. To support these goals, we are helping 
patients control their health data and make it easier to take their 
data with them as they move in and out of the healthcare system. This 
will let patients make informed choices about their care, leading to 
more competition and lower costs.
b. Summary of the Major Provisions
(1) Quality Payment Program Year 3
    We believe the third year of the Quality Payment Program should 
build upon the foundation that has been established in the first 2 
years, which provides a trajectory for clinicians moving to a 
performance-based payment system. This trajectory provides clinicians 
the ability to participate in the program through two pathways: MIPS 
and Advanced APMs.
(2) Payment Adjustments
    As discussed in section VII.F.8. of this proposed rule, for the 
2021 MIPS payment year and based on Advanced APM participation during 
the 2019 MIPS performance period, we estimate that between 160,000 and 
215,000 clinicians will become Qualifying APM Participants (QP). As a 
QP, an eligible clinician is exempt from the MIPS reporting 
requirements and payment adjustment, and qualifies for a lump sum 
incentive payment based on 5 percent of their aggregate payment amounts 
for covered professional services for the prior year. We estimate that 
the total lump sum APM incentive payments will be approximately $600-
800 million for the 2021 Quality Payment Program payment year.
    For MIPS, we have posted a blog that provides preliminary 
participation information for the first year of MIPS.\14\ However, due 
to time constraints, we are unable to incorporate and analyze the 
performance and participation data from the first year of MIPS for the 
estimates in this proposed rule. Therefore, under the policies proposed 
in this proposed rule, we based our estimates for the 2019 MIPS 
performance period/2021 MIPS payment year on historical 2016 PQRS and 
Medicare and Medicaid EHR Incentive Program data. We estimate that 
approximately 650,000 clinicians would be MIPS eligible clinicians in 
the 2019 MIPS performance period. This number will depend on a number 
of factors, including the number of eligible clinicians excluded from 
MIPS based on their status as QPs or Partial QPs, the number that 
report as groups, and the number that elect to opt-in to MIPS. In the 
2021 MIPS payment year, MIPS payment adjustments, which only apply to 
covered professional services, will be applied based on MIPS eligible 
clinicians' performance on specified measures and activities within 
four integrated performance categories. We estimate that MIPS payment 
adjustments will be approximately equally distributed between negative 
MIPS payment adjustments ($372 million) and positive MIPS payment 
adjustments ($372 million) to MIPS eligible clinicians, as required by 
the statute to ensure budget neutrality. Positive MIPS payment 
adjustments will also include up to an additional $500 million for 
exceptional performance to MIPS eligible clinicians whose final score 
meets or exceeds the proposed additional performance threshold of 80 
points. However, the distribution will change based on the final 
population of MIPS eligible clinicians for the 2021 MIPS payment year 
and the distribution of final scores under the program. We anticipate 
that we will be able to update these estimates with the data from the 
first year of MIPS in the CY 2019 Quality Payment Program final rule.
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    \14\ https://blog.cms.gov/2018/05/31/quality-payment-program-exceeds-year-1-participation-goal/.
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2. Definitions
    At Sec.  414.1305, subpart O--
     We define the following terms:
    ++ Ambulatory Surgical Center (ASC)-based MIPS eligible clinician.
    ++ Collection type.
    ++ Health IT vendor.
    ++ MIPS determination period.
    ++ Submission type.
    ++ Submitter type.
    ++ Third party intermediary.
     We revise the definitions of the following terms:
    ++ High priority measure.
    ++ Hospital-based MIPS eligible clinician
    ++ Low-volume threshold.
    ++ MIPS eligible clinician.
    ++ Non-patient facing MIPS eligible clinician.
    ++ Qualified Clinical Data Registry (QCDR).
    ++ Qualifying APM Participant (QP).
    ++ Small practices.
    These terms and definitions are discussed in detail in relevant 
sections of this proposed rule.
3. MIPS Program Details
a. MIPS Eligible Clinicians
    Under Sec.  414.1305, a MIPS eligible clinician, as identified by a 
unique billing TIN and NPI combination used to assess performance, is 
defined as any of the following (excluding those identified at Sec.  
414.1310(b)): A physician (as defined in section 1861(r) of the Act); a 
physician assistant, nurse practitioner, and clinical nurse specialist 
(as such terms are defined in section 1861(aa)(5) of the Act); a 
certified registered nurse anesthetist (as defined in section 
1861(bb)(2) of the Act); and a group that includes such clinicians. 
Section 1848(q)(1)(C)(II) of the Act provides the Secretary with 
discretion, beginning with the 2021 MIPS payment year, to specify 
additional eligible clinicians (as defined in section 1848(k)(3)(B) of 
the Act) as MIPS eligible clinicians. Such clinicians may include 
physical therapists, occupational therapists, or qualified speech-
language pathologists; qualified audiologists (as defined in section 
1861(ll)(3)(B) of the Act); certified nurse-midwives (as defined in 
section 1861(gg)(2) of the Act); clinical social workers (as defined in 
section 1861(hh)(1) of the Act); clinical psychologists (as defined by 
the Secretary for purposes of section 1861(ii) of the Act); and 
registered dietitians or nutrition professionals.
    We received feedback from non-physician associations representing 
each type of additional eligible clinician through listening sessions 
and meetings with various stakeholder entities and through public 
comments discussed in the CY 2017 Quality Payment Program final rule 
(81 FR 77038). Commenters generally supported the specification of such 
clinicians as MIPS eligible clinicians beginning with the 2021 MIPS 
payment year.
    To assess whether these additional eligible clinicians could 
successfully participate in MIPS, we evaluated whether there would be 
sufficient measures and activities applicable and available for each of 
the additional eligible clinician types. We focused our analysis on the 
quality and improvement activities performance categories because these 
performance categories require submission of data. We did not focus on 
the Promoting Interoperability performance category because there is 
extensive analysis regarding who can participate under the current 
exclusion criteria. In addition,

[[Page 35884]]

in section III.H.3.i.(2)(b) of this proposed rule, we are proposing to 
automatically assign a zero percent weighting for the Promoting 
Interoperability performance category for these new types of MIPS 
eligible clinicians. In addition, we did not focus on the cost 
performance category because we are only able to assess cost 
performance for a subset of eligible clinicians--those who are 
currently eligible as a result of not meeting any of the current 
exclusion criteria. So the impact of the cost performance category for 
these additional eligible clinicians will continue to be considered but 
is currently not a decisive factor. From our analysis, we found that 
improvement activities would generally be applicable and available for 
each of the additional eligible clinician types. However, for the 
quality performance category, we found that not all of the additional 
eligible clinician types would have sufficient MIPS quality measures 
applicable and available. As discussed in section III.H.3.h.(2)(b)(iii) 
of this proposed rule, for the quality performance category, we are 
proposing to remove several MIPS quality measures. If those measures 
are finalized for removal, we anticipate that qualified speech-language 
pathologists, qualified audiologists, certified nurse-midwives, and 
registered dietitians or nutrition professionals would each have less 
than 6 MIPS quality measures applicable and available to them. However, 
if the quality measures are not finalized for removal, we will reassess 
whether these eligible clinicians would have an adequate amount of MIPS 
quality measures available to them. If we find that these additional 
clinicians do have at least 6 MIPS quality measures available to them, 
then we propose to include them in the MIPS eligible clinician 
definition. We are focusing on the quality performance category because 
as discussed above, the quality and improvement activities performance 
categories require submission of data. We believe there would generally 
be applicable and available improvement activities for each of the 
additional eligible clinician types, but that not all of the additional 
eligible clinician types would have sufficient MIPS quality measures 
applicable and available if the proposed MIPS quality measures are 
removed from the program. We did find QCDR measures approved for the CY 
2018 performance period that are either high priority and/or outcome 
measures that, if approved for the CY 2019 performance period, may be 
applicable to these additional eligible clinicians. However, this would 
necessitate that they utilize a QCDR in order to be successful in MIPS.
    Further, we have heard some concerns from the non-physician 
associations, through written correspondence, that since their 
clinicians would be joining the program 2 years after its inception, we 
should consider several ramp-up policies in order to facilitate an 
efficient integration of these clinicians into MIPS. We note that the 
MIPS program is still ramping up, and we will continue to increase the 
performance threshold to ensure a gradual and incremental transition to 
the performance threshold until Quality Payment Program Year 6. 
Therefore, if specified as MIPS eligible clinicians beginning with the 
2021 MIPS payment year, the additional eligible clinicians would have 4 
years in the program in order to ramp up. Conversely, if specified as 
MIPS eligible clinicians beginning in a future year, they would be 
afforded less time to ramp up the closer the program gets to Quality 
Payment Program Year 6.
    Therefore, we request comments on our proposal to amend Sec.  
414.1305 to modify the definition of a MIPS eligible clinician, as 
identified by a unique billing TIN and NPI combination used to assess 
performance, to mean any of the following (excluding those identified 
at Sec.  414.1310(b)): A physician (as defined in section 1861(r) of 
the Act); a physician assistant, nurse practitioner, and clinical nurse 
specialist (as such terms are defined in section 1861(aa)(5) of the 
Act); a certified registered nurse anesthetist (as defined in section 
1861(bb)(2) of the Act); beginning with the 2021 MIPS payment year, a 
physical therapist, occupational therapist, clinical social worker (as 
defined in section 1861(hh)(1) of the Act), and clinical psychologist 
(as defined by the Secretary for purposes of section 1861(ii) of the 
Act); and a group that includes such clinicians. Alternatively, we 
propose that if the quality measures proposed for removal are not 
finalized, then we would include additional eligible clinician types in 
the definition of a MIPS eligible clinician beginning with the 2021 
MIPS payment year (specifically, qualified speech-language 
pathologists, qualified audiologists, certified nurse-midwives, and 
registered dietitians or nutrition professionals), provided that we 
determine that each applicable eligible clinician type would have at 
least 6 MIPS quality measures available to them. In addition, we are 
requesting comments on: (1) Specifying qualified speech-language 
pathologists, qualified audiologists, certified nurse-midwives, and 
registered dietitians or nutrition professionals as MIPS eligible 
clinicians beginning with the 2021 MIPS payment year; and (2) delaying 
the specification of one or more additional eligible clinician types as 
MIPS eligible clinicians until a future MIPS payment year.
b. MIPS Determination Period
    Currently, MIPS uses various determination periods to identify 
certain MIPS eligible clinicians for consideration for certain 
applicable policies. For example, the low-volume threshold, non-patient 
facing, small practice, hospital-based, and ambulatory surgical center 
(ASC)-based determinations are on the same timeline with slight 
differences in the claims run-out policies, whereas the facility-based 
determinations has a slightly different determination period. The 
virtual group eligibility determination requires a separate election 
process. We are proposing in this rule to add a virtual group 
eligibility determination period beginning in CY 2020 as discussed in 
section III.H.3.f.(2)(a) of this proposed rule. In addition, the rural 
and health professional shortage area (HPSA) determinations do not 
utilize a determination period.
    Under Sec.  414.1305, the low-volume threshold determination period 
is described as a 24-month assessment period consisting of an initial 
12-month segment that spans from the last 4 months of the calendar year 
2 years prior to the performance period through the first 8 months of 
the calendar year preceding the performance period, and a second 12-
month segment that spans from the last 4 months of the calendar year 1 
year prior to the performance period through the first 8 months of the 
calendar year performance period. An individual eligible clinician or 
group that is identified as not exceeding the low-volume threshold 
during the initial 12-month segment will continue to be excluded under 
Sec.  414.1310(b)(1)(iii) for the applicable year regardless of the 
results of the second 12-month segment analysis. For the 2020 MIPS 
payment year and future years, each segment of the low-volume threshold 
determination period includes a 30-day claims run out.
    Under Sec.  414.1305, the non-patient facing determination period 
is described as a 24-month assessment period consisting of an initial 
12-month segment that spans from the last 4 months of the calendar year 
2 years prior to the performance period through the first 8 months of 
the calendar year preceding the performance period and a second 12-
month segment that spans from the last 4 months of the calendar year 1 
year prior to the performance

[[Page 35885]]

period through the first 8 months of the calendar year performance 
period. An individual eligible MIPS clinician, group, or virtual group 
that is identified as non-patient facing during the initial 12-month 
segment will continue to be considered non-patient facing for the 
applicable year regardless of the results of the second 12-month 
segment analysis. For the 2020 MIPS payment year and future years, each 
segment of the non-patient facing determination period includes a 30-
day claims run out.
    In the CY 2018 Quality Payment Program final rule (82 FR 53581), we 
finalized that for the small practice size determination period, we 
would utilize a 12-month assessment period, which consists of an 
analysis of claims data that spans from the last 4 months of a calendar 
year 2 years prior to the performance period followed by the first 8 
months of the next calendar year and includes a 30-day claims run out.
    In the CY 2017 Quality Payment Program final rule (81 FR 77238 
through 77240), we finalized that to identify a MIPS eligible clinician 
as hospital-based we would use claims with dates of service between 
September 1 of the calendar year 2 years preceding the performance 
period through August 31 of the calendar year preceding the performance 
period, but in the event it is not operationally feasible to use claims 
from this time period, we would use a 12-month period as close as 
practicable to this time period.
    In the CY 2018 Quality Payment Program final rule (82 FR 53684 
through 53685), we finalized that to identify a MIPS eligible clinician 
as ASC-based, we would use claims with dates of service between 
September 1 of the calendar year 2 years preceding the performance 
period through August 31 of the calendar year preceding the performance 
period, but in the event it is not operationally feasible to use claims 
from this time period, we would use a 12-month period as close as 
practicable to this time period.
    In the CY 2018 Quality Payment Program final rule (82 FR 53760), we 
discussed, but did not finalize, our proposal or the alternative option 
for how an individual clinician or group would elect to use and be 
identified as using facility-based measurement for the MIPS program. 
Because we were not offering facility-based measurement until the 2019 
MIPS performance period, we did not need to finalize either of these 
for the 2018 MIPS performance period. However, in section 
III.H.3.i.(1)(d) of this proposed rule, we are proposing to amend Sec.  
414.1380(e)(2)(i)(A) to specify a criterion for a clinician to be 
eligible for facility-based measurement. Specifically, that is, the 
clinician furnishes 75 percent or more of his or her covered 
professional services in sites of service identified by the place of 
service codes used in the HIPAA standard transaction as an inpatient 
hospital, on-campus outpatient hospital, or emergency room setting 
based on claims for a 12-month segment beginning on October 1 of the 
calendar year 2 years prior to the applicable performance period and 
ending on September 30 of the calendar year preceding the applicable 
performance period with a 30-days claims run out. We are not proposing 
to utilize the MIPS determination period for purposes of the facility-
based determination because for the facility-based determination, we 
are only using the first segment of the MIPS determination period. We 
are using the first segment because the performance period for measures 
in the hospital value-based purchasing program overlapped in part with 
that determination period. If we were to use the second segment, we 
could not be assured that the clinician actually worked in the hospital 
on which their MIPS score would be based during that time. We believe 
this approach provides clarity and is a cleaner than providing a 
special exception for the facility-based determination in the MIPS 
determination period for the second segment. We refer readers to 
section III.H.3.i.(1)(d) for further details on the facility-based 
determinations and the time periods that are applicable to those 
determinations.
    In the CY 2018 Quality Payment Program final rule (82 FR 53602 
through 53604), we finalized that for the virtual group eligibility 
determination period, we would utilize an analysis of claims data 
during an assessment period of up to 5 months that would begin on July 
1 and end as late as November 30 of the calendar year prior to the 
applicable performance period and include a 30-day claims run out. To 
capture a real-time representation of TIN size, we finalized that we 
would analyze up to 5 months of claims data on a rolling basis, in 
which virtual group eligibility determinations for each TIN would be 
updated and made available monthly. We noted that an eligibility 
determination regarding TIN size is based on a relative point in time 
within the 5-month virtual group eligibility determination period, and 
not made at the end of such 5-month determination period. Beginning 
with the 2019 performance period, we are proposing to amend Sec.  
414.1315(c)(1) to establish a virtual group eligibility determination 
period to align with the first segment of the MIPS determination 
period, which includes an analysis of claims data during a 12-month 
assessment period (fiscal year) that would begin on October 1 of the 
calendar year 2 years prior to the applicable performance period and 
end on September 30 of the calendar year preceding the applicable 
performance period and include a 30-day claims run out. We refer 
readers to section III.H.3.f.(2)(a) for further details on this 
proposal.
    In addition, we have established other special status 
determinations, including rural area and HPSA. Rural area is defined at 
Sec.  414.1305 as a ZIP code designated as rural, using the most recent 
Health Resources and Services Administration (HRSA) Area Health 
Resource File data set available. HPSAs are defined at Sec.  414.1305 
as areas designated under section 332(a)(1)(A) of the Public Health 
Service Act.
    We understand that the current use of various MIPS determination 
periods is complex and causes confusion. Therefore, beginning with the 
2021 MIPS payment year, we propose to consolidate several of these 
policies into a single MIPS determination period that would be used for 
purposes of the low-volume threshold and to identify MIPS eligible 
clinicians as non-patient facing, a small practice, hospital-based, and 
ASC-based, as applicable. We are not proposing to include the facility-
based or virtual group eligibility determination periods or the rural 
and HPSA determinations in the MIPS determination period, as they each 
require a different process or timeline that does not align with the 
other determination periods, or do not utilize determination periods. 
We invite public comments on the possibility of incorporating these 
determinations into the MIPS determination period in the future.
    There are several reasons we believe a single MIPS determination 
period for most of the eligibility criteria is the most appropriate. 
First, it would simplify the program by aligning most of the MIPS 
eligibility determination periods. Second, it would continue to allow 
us to provide eligibility determinations as close to the beginning of 
the performance period as feasible. Third, we believe a timeframe that 
aligns with the fiscal year is easier to communicate and more 
straightforward to understand compared to the current determination 
periods. Finally, it would allow us to extend our data analysis an 
additional 30 days.
    It is important to note that during the final 3 months of the 
calendar year in

[[Page 35886]]

which the performance period occurs, in general, we do not believe it 
would be feasible for many MIPS eligible clinicians who join an 
existing practice (existing TIN) or join a newly formed practice (new 
TIN) to participate in MIPS as individuals. We refer readers to section 
III.H.3.i.(2)(b) of this proposed rule for more information on the 
proposed reweighting policies for MIPS eligible clinicians who join an 
existing practice or who join a newly formed practice during this 
timeframe.
    We request comments on our proposal that beginning with the 2021 
MIPS payment year, the MIPS determination period would be a 24-month 
assessment period including a two-segment analysis of claims data 
consisting of: (1) An initial 12-month segment beginning on October 1 
of the calendar year 2 years prior to the applicable performance period 
and ending on September 30 of the calendar year preceding the 
applicable performance period; and (2) a second 12-month segment 
beginning on October 1 of the calendar year preceding the applicable 
performance period and ending on September 30 of the calendar year in 
which the applicable performance period occurs. The first segment would 
include a 30-day claims run out. The second segment would not include a 
claims run out, but would include quarterly snapshots for informational 
use only, if technically feasible. For example, a clinician could use 
the quarterly snapshots to understand their eligibility status between 
segments. Specifically, we believe the quarterly snapshots would be 
helpful for new TIN/NPIs and TINs created between the first segment and 
the second segment allowing them to see their preliminary eligibility 
status sooner. Without the quarterly snapshots, these clinicians would 
not have any indication of their eligibility status until just before 
the submission period. An individual eligible clinician or group that 
is identified as not exceeding the low-volume threshold, or a MIPS 
eligible clinician that is identified as non-patient facing, a small 
practice, hospital-based, or ASC-based, as applicable, during the first 
segment would continue to be identified as such for the applicable MIPS 
payment year regardless of the second segment. For example, for the 
2021 MIPS payment year, the first segment would be October 1, 2017 
through September 30, 2018, and the second segment would be October 1, 
2018 through September 30, 2019. However, based on our experience with 
the Quality Payment Program, we believe that some eligible clinicians, 
whose TIN or TIN/NPIs are identified as eligible during the first 
segment and do not exist in the second segment, are no longer utilizing 
these same TIN or TIN/NPI combinations. Therefore, because those TIN or 
TIN/NPIs would not exceed the low-volume threshold in the second 
segment, they would no longer be eligible for MIPS. For example, in the 
2019 performance period a clinician exceeded the low-volume threshold 
during the first segment of the determination period (data from the end 
of CY 2017 to early 2018) under one TIN; then in CY 2019 the clinician 
switches practices under a new TIN and during segment two of the 
determination period. Therefore, it is determined that the clinician is 
not eligible (based on CY 2019 data) under either TIN. This clinician 
would not be eligible to participate in MIPS based on either segment of 
the determination period because the TIN that was assessed for the 
first segment of the determination period no longer exists. So there 
are no charges or services that would be available to assess in the 
second segment for that TIN and the new TIN assessed during the second 
segment was not eligible. In this scenario, though the clinician 
exceeded the low-volume threshold criteria initially, the clinician is 
not required to submit any data based on TIN eligibility 
determinations. However, it is important to note that if a TIN or TIN/
NPI did not exist in the first segment but does exist in the second 
segment, these eligible clinicians could be eligible for MIPS. For 
example, the eligible clinician may not find their TIN or TIN/NPI in 
the Quality Payment Program lookup tool but may still be eligible if 
they exceed the low-volume threshold in the second segment. We proposed 
to incorporate this policy into our proposed definition of MIPS 
determination period at Sec.  414.1305. We also request comments on our 
proposals to define MIPS determination period at Sec.  414.1305 and 
modify the definitions of low-volume threshold, non-patient facing, a 
small practice, hospital-based, and ASC-based at Sec.  414.1305 to 
incorporate references to the MIPS determination period.
c. Low-Volume Threshold
(1) Overview
    Section 1848(q)(1)(C)(iv) of the Act, as amended by section 
51003(a)(1)(A)(ii) of the Bipartisan Budget Act of 2018, provides that, 
for performance periods beginning on or after January 1, 2018, the low-
volume threshold selected by the Secretary may include one or more or a 
combination of the following (as determined by the Secretary): (1) The 
minimum number of part B-enrolled individuals who are furnished covered 
professional services (as defined in section 1848(k)(3)(A) of the Act) 
by the eligible clinician for the performance period involved; (2) the 
minimum number of covered professional services furnished to part B-
enrolled individuals by such clinician for such performance period; and 
(3) the minimum amount of allowed charges for covered professional 
services billed by such clinician for such performance period.
    Under Sec.  414.1310(b)(1)(iii), for a year, eligible clinicians 
who do not exceed the low-volume threshold for the performance period 
with respect to a year are excluded from MIPS. Under Sec.  414.1305, 
the low-volume threshold is defined as, for the 2019 MIPS payment year, 
the low-volume threshold that applies to an individual eligible 
clinician or group that, during the low-volume threshold determination 
period, has Medicare Part B allowed charges less than or equal to 
$30,000 or provides care for 100 or fewer Part B-enrolled Medicare 
beneficiaries. In addition, for the 2020 MIPS payment year and future 
years, the low-volume threshold is defined as the low-volume threshold 
that applies to an individual eligible clinician or group that, during 
the low-volume threshold determination period, has Medicare Part B 
allowed charges less than or equal to $90,000 or provides care for 200 
or fewer Part B-enrolled Medicare beneficiaries. The low-volume 
threshold determination period is a 24-month assessment period 
consisting of: (1) An initial 12-month segment that spans from the last 
4 months of the calendar year 2 years prior to the performance period 
through the first 8 months of the calendar year preceding the 
performance period; and (2) a second 12-month segment that spans from 
the last 4 months of the calendar year 1 year prior to the performance 
period through the first 8 months of the calendar year performance 
period. An individual eligible clinician or group that is identified as 
not exceeding the low-volume threshold during the initial 12-month 
segment will continue to be excluded under Sec.  414.1310(b)(1)(iii) 
for the applicable year regardless of the results of the second 12-
month segment analysis. For the 2019 MIPS payment year, each segment of 
the low-volume threshold determination period includes a 60-day claims 
run out. For the 2020 MIPS payment year, each segment of the low-volume 
threshold determination period includes a 30-day claims run out.

[[Page 35887]]

(2) Proposed Amendments To Comply With the Bipartisan Budget Act of 
2018
    In this proposed rule, we are proposing to amend Sec.  414.1305 to 
modify the definition of low-volume threshold in accordance with 
section 1848(q)(1)(C)(iv) of the Act, as amended by section 
51003(a)(1)(A)(ii) of the Bipartisan Budget Act of 2018. Specifically, 
we request comments on our proposals that for the 2020 MIPS payment 
year, we will utilize the minimum number (200 patients) of Part B-
enrolled individuals who are furnished covered professional services by 
the eligible clinician or group during the low-volume threshold 
determination period or the minimum amount ($90,000) of allowed charges 
for covered professional services to Part B-enrolled individuals by the 
eligible clinician or group during the low-volume threshold 
determination period.
(3) MIPS Program Details
    We request comments on our proposal to modify Sec.  414.1310 to 
specify in paragraph (a), Program Implementation, that except as 
specified in paragraph (b), MIPS applies to payments for covered 
professional services furnished by MIPS eligible clinicians on or after 
January 1, 2019. We also request comments on our proposal to revise 
Sec.  414.1310(b)(1)(ii) to specify that for a year, a MIPS eligible 
clinician does not include an eligible clinician that is a Partial 
Qualifying APM Participant (as defined in Sec.  414.1305) and does not 
elect, as discussed in section III.H.4.e. of this proposed rule, to 
report on applicable measures and activities under MIPS. Finally, we 
request comments on our proposal to revise Sec.  414.1310(d) to specify 
that, in no case will a MIPS payment adjustment factor (or additional 
MIPS payment adjustment factor) apply to payments for covered 
professional services furnished during a year by eligible clinicians 
(including those described in paragraphs (b) and (c) of this section) 
who are not MIPS eligible clinicians, including those who voluntarily 
report on applicable measures and activities under MIPS.
(4) Proposed Addition of Low-Volume Threshold Criterion Based on Number 
of Covered Professional Services
    In the CY 2018 Quality Payment Program final rule (82 FR 53591), we 
received several comments in response to the proposed rule regarding 
adding a third criterion of ``items and services'' for defining the 
low-volume threshold. We refer readers to that rule for further 
details.
    For the 2021 MIPS payment year and future years, we are proposing 
to add one additional criterion to the low-volume threshold 
determination--the minimum number of covered professional services 
furnished to Part B-enrolled individuals by the clinician. 
Specifically, we request comments on our proposal, for the 2021 MIPS 
payment year and future years, that eligible clinicians or groups who 
meet at least one of the following three criteria during the MIPS 
determination period would not exceed the low-volume threshold: (1) 
Those who have allowed charges for covered professional services less 
than or equal to $90,000; (2) those who provide covered professional 
services to 200 or fewer Part B-enrolled individuals; or (3) those who 
provide 200 or fewer covered professional services to Part B-enrolled 
individuals.
    For the third criterion, we are proposing to set the threshold at 
200 or fewer covered professional services furnished to Part B-enrolled 
individuals for several reasons. First, in the CY 2018 Quality Payment 
Program final rule (82 FR 53589 through 53590), while we received 
positive feedback from stakeholders on the increased low-volume 
threshold, we also heard from some stakeholders that they would like to 
participate in the program. Second, setting the third criterion at 200 
or fewer covered professional services allows us to ensure that a 
significant number of eligible clinicians have the ability to opt-in if 
they wish to participate in MIPS. Finally, when we were considering 
where to set the low-volume threshold for covered professional 
services, we examined two options: 100 or 200 covered professional 
services. For 100 covered professional services, there is some 
historical precedent. In the CY 2017 Quality Payment Program final rule 
(81 FR 77062), we finalized a low-volume threshold that excluded 
individual eligible clinicians or groups that have Medicare Part B 
allowed charges less than $30,000 or that provide care for 100 or fewer 
Part B-enrolled Medicare beneficiaries; we believe the latter criterion 
is comparable to 100 covered professional services. Conversely for 200 
covered professional services, in the CY 2018 Quality Payment Program 
final rule comment period (82 FR 53588), we discussed that based on our 
data analysis, excluding individual eligible clinicians or groups that 
have Medicare Part B allowed charges less than or equal to $90,000 or 
that provide care for 200 or fewer Part B-enrolled Medicare 
beneficiaries decreased the percentage of MIPS eligible clinicians that 
come from small practices. In addition, in the CY 2018 Quality Payment 
final rule (82 FR 53955), we codified at Sec.  414.1380(b)(1)(iv) a 
minimum case requirements for quality measures are 20 cases which both 
services threshold considerations (100 or 200) exceed and at Sec.  
414.1380(b)(1)(v) a minimum case requirements for the all-cause 
hospital readmission measure is 200 cases, which only the 200 services 
threshold consideration exceeds. We believe that setting a threshold of 
200 services for the third criterion strikes the appropriate balance 
between allowing a significant number of eligible clinicians the 
ability to opt-in (as described below) to MIPS and consistency with the 
previously established low-volume threshold criteria. In section 
VII.F.8.b. of this proposed rule, we estimate no additional clinicians 
would be excluded if we add the third criterion because a clinician 
that cares for at least 200 beneficiaries would have at least 100 or 
200 services; however, we estimate 42,025 clinicians would opt-in with 
the low-volume threshold at 200 services, as compared to 19,621 
clinicians if we did not add the third criterion. If we set the third 
criterion at 100 services, then we estimate 50,260 clinicians would 
opt-in.
(5) Low-Volume Threshold Opt-In
    In the CY 2018 Quality Payment Program final rule (82 FR 53589), we 
proposed the option to opt-in to MIPS participation if clinicians might 
otherwise be excluded under the low-volume threshold. We received 
general support from comments received in the CY 2018 Quality Payment 
Program final rule (82 FR 53589). However, we did not finalize the 
proposal for the 2019 MIPS performance period. We were concerned that 
we would not be able to operationalize this policy in a low-burden 
manner to MIPS eligible clinicians as it was proposed.
    After consideration of operational and user experience implications 
of an opt-in policy, we are proposing an approach we believe can be 
implemented in a way that provides the least burden to clinicians. We 
are proposing to modify Sec.  414.1310(b)(1)(iii) to provide that 
beginning with the 2021 MIPS payment year, if an eligible clinician or 
group meets or exceeds at least one, but not all, of the low-volume 
threshold determinations, including as defined by dollar amount (less 
than or equal to $90,000) or number of beneficiaries (200 or fewer), or 
number of covered professional services (200 or fewer), then such 
eligible individual or group may choose to opt-in to MIPS.

[[Page 35888]]

    This policy would apply to individual eligible clinicians and 
groups who exceed at least one, but not all, of the low-volume 
threshold criteria and would otherwise be excluded from MIPS 
participation as a result of the low-volume threshold. We believe that 
it would be beneficial to provide, to the extent feasible, such 
individual eligible clinicians and groups with the ability to opt-in to 
MIPS. Conversely, this policy would not apply to individual eligible 
clinicians and groups who exceed all of the low-volume threshold 
criteria, who unless otherwise excluded, are required to participate in 
MIPS. In addition, this policy would not apply to individual eligible 
clinicians and groups who do not exceed any of the low-volume threshold 
criteria, who would be excluded from MIPS participation without the 
ability to opt-in to MIPS. While we believe we are proposing the 
appropriate balance for the low-volume threshold elements, we request 
comments on other low-volume threshold criteria and supporting 
justification for the recommended criteria.
    Under the proposed policies, we estimate clinician eligibility 
based on the following (we refer readers to the regulatory impact 
analysis in section VII.F.8.b. of this proposed rule for further 
details on our assumptions): (1) Eligible because they exceed all three 
criteria of the low-volume threshold and are not otherwise excluded 
(estimated 608,000 based on our assumptions of who did individual and 
group reporting); (2) eligible because they exceed at least one, but 
not all, of the low-volume threshold criteria and elect to opt-in 
(estimated 42,000 for a total MIPS eligible clinician population of 
approximately 650,000); (3) potentially eligible if they either did 
group reporting or elected to opt-in \15\ (estimated 483,000); (4) 
excluded because they do not exceed any of the low-volume threshold 
criteria (estimated 88,000); and (5) excluded due to non-eligible 
specialty, newly enrolled, or QP status (estimated 302,000).
---------------------------------------------------------------------------

    \15\ A clinician may be in a group that we estimated would not 
elect group reporting, however, the group would exceed the low-
volume threshold on all three criteria if the group elected group 
reporting. Similarly, an individual or group may exceed at least one 
but not all of the low-volume threshold criteria, but we estimated 
the clinician or group would not elect to opt-in to MIPS. In both 
cases, these clinicians could be eligible for MIPS if the group or 
individual makes choices that differ from our assumptions.
---------------------------------------------------------------------------

    We are proposing that applicable eligible clinicians who meet one 
or two, but not all, of the criteria to opt-in and are interested in 
participating in MIPS would be required to make a definitive choice to 
either opt-in to participate in MIPS or choose to voluntarily report 
before data submission. If they did not want to participate in MIPS, 
they would not be required to do anything and would be excluded from 
MIPS under the low-volume threshold. For those who did want to 
participate in MIPS, we considered the option of allowing the 
submission of data to signal that the clinician is choosing to 
participate in MIPS. However, we anticipated that some clinicians who 
utilize the quality data code (QDC) claims submission type may have 
their systems coded to automatically append QDCs on claims for eligible 
patients. We were concerned that they could submit a QDC code and 
inadvertently opt-in when that was not their intention.
    For individual eligible clinicians and groups to make an election 
to opt-in or voluntarily report to MIPS, they would make an election 
via the Quality Payment Program portal by logging into their account 
and simply selecting either the option to opt-in (positive, neutral, or 
negative MIPS adjustment) or to remain excluded and voluntarily report 
(no MIPS adjustment). Once the eligible clinician has elected to 
participate in MIPS, the decision to opt-in to MIPS would be 
irrevocable and could not be changed for the applicable performance 
period. Clinicians who opt-in would be subject to the MIPS payment 
adjustment during the applicable MIPS payment year. Clinicians who do 
not decide to opt-in to MIPS would remain excluded and may choose to 
voluntarily report. Such clinicians would not receive a MIPS payment 
adjustment factor. To assist commenters in providing pertinent 
comments, we have developed a website that provides design examples of 
the different approaches to MIPS participation in CY 2019. The website 
uses wireframe (schematic) drawings to illustrate the three different 
approaches to MIPS participation: Voluntary reporting to MIPS, opt-in 
reporting to MIPS, and required to participate in MIPS. We refer 
readers to the Quality Payment Program at qpp.cms.gov/design-examples 
to review these wireframe drawings. The website will provide specific 
matrices illustrating potential stakeholder experiences when opting-in 
or voluntarily reporting.
    It should be noted that the option to opt-in to participate in the 
MIPS as a result of an individual eligible clinician or group exceeding 
at least one, but not all, of the low-volume threshold elements differs 
from the option to voluntarily report to the MIPS as established at 
Sec.  414.1310(b)(2) and (d). Individual eligible clinicians and groups 
opting-in to participate in MIPS would be considered MIPS eligible 
clinicians, and therefore subject to the MIPS payment adjustment 
factor; whereas, individual eligible clinicians and groups voluntarily 
reporting measures and activities for the MIPS are not considered MIPS 
eligible clinicians, and therefore not subject to the MIPS payment 
adjustment factor. MIPS eligible clinicians and groups that made an 
election to opt-in would be able to participate in MIPS at the 
individual, group, or virtual group level for that performance period. 
Eligible clinicians and groups that are excluded from MIPS, but 
voluntarily report, are able to report measures and activities at the 
individual or group level; however, such eligible clinicians and groups 
are not able to voluntarily report for MIPS at the virtual group level.
    In Table 28, we are providing possible scenarios regarding which 
eligible clinicians may be able to opt-in to MIPS depending upon their 
beneficiary count, dollars, and covered professional services if the 
proposed opt-in policy was finalized.

                                              Table 28--Low-Volume Threshold Determination Opt-In Scenarios
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                     Covered  professional
      Beneficiaries                Dollars                  services                                     Eligible for opt-in
--------------------------------------------------------------------------------------------------------------------------------------------------------
<=200...................  <=90K...................  <=200..................  Excluded not eligible to Opt-in.
<=200...................  <=90K...................  >200...................  Eligible to Opt-in, Voluntarily Report, or Not Participate.
<=200...................  >90K....................  <=200..................  Eligible to Opt-in, Voluntarily Report, or Not Participate.
>200....................  <=90K...................  >200...................  Eligible to Opt-in, Voluntarily Report, or Not Participate.
>200....................  >90K....................  >200...................  Not eligible to Opt-in, Required to Participate.
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 35889]]

    We recognize that the low-volume threshold opt-in option may expand 
MIPS participation at the individual, group, and virtual group levels. 
For solo practitioners and groups with 10 or fewer eligible clinicians 
(including at least one MIPS eligible clinician) that exceed at least 
one, but not all, of the elements of the low-volume threshold and are 
interested in participating in MIPS via the opt-in and doing so as part 
of a virtual group, such solo practitioners and groups would need to 
make an election to opt-in to participate in the MIPS. Therefore, 
beginning with the 2021 MIPS payment year, we are proposing that a 
virtual group election would constitute a low-volume threshold opt-in 
for any prospective member of the virtual group (solo practitioner or 
group) that exceeds at least one, but not all, of the low-volume 
threshold criteria. As a result of the virtual group election, any such 
solo practitioner or group would be treated as a MIPS eligible 
clinician for the applicable MIPS payment year.
    During the virtual group election process, the official virtual 
group representative of a virtual group submits an election to 
participate in the MIPS as a virtual group to CMS prior to the start of 
a performance period (82 FR 53601 through 53604). The submission of a 
virtual group election includes TIN and NPI information, which is the 
identification of TINs composing the virtual group and each member of 
the virtual group. As part of a virtual group election, the virtual 
group representative is required to confirm through acknowledgement 
that a formal written agreement is in place between each member of the 
virtual group (82 FR 53604). A virtual group may not include a solo 
practitioner or group as part of a virtual group unless an authorized 
person of the TIN has executed a formal written agreement.
    For a solo practitioner or group that exceeds only one or two 
elements of the low-volume threshold, an election to opt-in to 
participate in the MIPS as part of a virtual group would be represented 
by being identified as a TIN that is included in the submission of a 
virtual group election. Such solo practitioners and groups opting-in to 
participate in the MIPS as part of a virtual group would not need to 
independently make a separate election to opt-in to participate in the 
MIPS. It should be noted that being identified as a TIN in a submitted 
virtual group election, any such TIN (represented as a solo 
practitioner or group) that exceeds at least one, but not all, of the 
low-volume threshold elements during the MIPS determination period is 
signifying an election to opt-in to participate in MIPS as part of a 
virtual group and recognizing that a MIPS payment adjustment factor 
would be applied to any such TIN based on the final score of the 
virtual group. For a virtual group election that includes a TIN 
determined to exceed at least one, but not all, of the low-volume 
threshold elements during the MIPS determination period, such election 
would have a precedence over the eligibility determination made during 
the MIPS determination period pertaining to the low-volume threshold 
and as a result, any such TIN would be considered MIPS eligible and 
subject to a MIPS payment adjustment factor due the virtual group 
election. Furthermore, we note that a virtual group election would 
constitute an election to opt-in to participate in MIPS and any low-
volume threshold determinations that result from segment 2 data 
analysis of the MIPS determination period would not have any bearing on 
the virtual group election. Thus, a TIN included as part of a virtual 
group election that submitted prior to the start of the applicable 
performance period and does not exceed at least one element of the low-
volume threshold during segment 2 of the MIPS determination period, 
such TIN would be considered MIPS eligible and a virtual group 
participant by virtue of the virtual group's election to participate in 
MIPS as a virtual group that was made prior to the applicable 
performance period. For virtual groups with a composition that may only 
consist of solo practitioners and groups that exceed at least one, but 
not all of the low-volume threshold elements, such virtual groups are 
encouraged to form a virtual group that would include a sufficient 
number of TINs to ensure that such virtual groups are able to meet 
program requirements such as case minimum criteria that would allow 
measures to be scored. For example, if a virtual group does not have a 
sufficient number of cases to report for quality measures (minimum of 
20 cases per episode-based measures), a virtual group would not be 
scored on such measures (81 FR 77175).
    We further note that for APM Entities in MIPS APMs, which meet one 
or two, but not all, of the low-volume threshold elements to opt-in and 
are interested in participating in MIPS under the APM scoring standard, 
would be required to make a definitive choice at the APM Entity level 
to opt-in to participate in MIPS. For such APM Entities to make an 
election to opt-in to MIPS, they would make an election via a similar 
process that individual eligible clinicians and groups will use to make 
an election to opt-in. Once the APM Entity has elected to participate 
in MIPS, the decision to opt-in to MIPS is irrevocable and cannot be 
changed for the performance period in which the data was submitted. 
Eligible clinicians in APM Entities in MIPS APMs that opt-in would be 
subject to the MIPS payment adjustment factor. APM Entities in MIPS 
APMs that do not decided to opt-in to MIPS cannot voluntarily report.
    Additionally, we are proposing for applicable eligible clinicians 
participating in a MIPS APM, whose APM Entity meets one or two, but not 
all, of the low-volume threshold elements rendering the option to opt-
in and does not decide to opt-in to MIPS, that if their TIN or virtual 
group does elect to opt-in, it does not mean that the eligible 
clinician is opting-in on his/her own behalf, or on behalf of the APM 
Entity, but that the eligible clinician is still excluded from MIPS 
participation as part of the APM Entity even though such eligible 
clinician is part of a TIN or virtual group. This is necessary because 
low-volume threshold determinations are currently conducted at the APM 
Entity level for all applicable eligible clinicians in MIPS APMs, and 
therefore, the low-volume threshold opt-in option should similarly be 
executed at the APM Entity level rather than at the individual eligible 
clinician, TIN, or virtual group level. Thus, in order for an APM 
Entity to opt-in to participate in MIPS at the APM Entity level and for 
eligible clinicians within such APM Entity to be subject to the MIPS 
payment adjustment factor, an election would need to be made at the APM 
Entity level in a similar process that individual eligible clinicians 
and groups would use to make an election to opt-in to participate in 
MIPS.
    We request comments on our proposals: (1) To modify Sec.  414.1305 
for the low-volume threshold definition at (3) to specify that, 
beginning with the 2021 MIPS payment year, the low-volume threshold 
that applies to an individual eligible clinician or group that, during 
the MIPS determination period, has allowed charges for covered 
professional services less than or equal to $90,000, furnishes covered 
professional services to 200 or fewer Medicare Part B-enrolled 
individuals, or furnishes 200 or fewer covered professional services to 
Medicare Part B-enrolled individuals; (2) that a clinician who is 
eligible to opt-in would be required to make an affirmative election to 
opt-in to participate in MIPS, elect to be a voluntary reporter, or by 
not submitting any data the clinician is choosing to not report; and 
(3) to modify

[[Page 35890]]

Sec.  414.1310(b)(1)(iii) under Applicability to specify exclusions as 
follows: Beginning with the 2021 MIPS payment year, if an individual 
eligible clinician, group, or APM Entity group in a MIPS APM exceeds at 
least one, but not all, of the low-volume threshold criteria and elects 
to report on applicable measures and activities under MIPS, the 
individual eligible clinician, group, or APM Entity group is treated as 
a MIPS eligible clinician for the applicable MIPS payment year. For APM 
Entity groups in MIPS APMs, only the APM Entity group election can 
result in the APM Entity group being treated as MIPS eligible 
clinicians for the applicable payment year.
(6) Part B Services Subject to MIPS Payment Adjustment
    Section 1848(q)(6)(E) of the Act, as amended by section 
51003(a)(1)(E) of the Bipartisan Budget Act of 2018, provides that the 
MIPS adjustment factor and, as applicable, the additional MIPS 
adjustment factor, apply to the amount otherwise paid under Part B with 
respect to covered professional services (as defined in subsection 
(k)(3)(A) of the Act) furnished by a MIPS eligible clinician during a 
year (beginning with 2019) and with respect to the MIPS eligible 
clinician for such year.
    In this proposed rule, we are requesting comments on our proposal 
to amend Sec.  414.1405(e) to modify the application of both the MIPS 
adjustment factor and, if applicable, the additional MIPS adjustment 
factor so that beginning with the 2019 MIPS payment year, these 
adjustment factors will apply to Part B payments for covered 
professional services (as defined in section 1848(k)(3)(A) of the Act) 
furnished by the MIPS eligible clinician during the year. We are making 
this change beginning with the first MIPS payment year and note that 
these adjustment factors will not apply to Part B drugs and other items 
furnished by a MIPS eligible clinician, but will apply to covered 
professional services furnished by a MIPS eligible clinician. We refer 
readers to section III.H.3.j. of this proposed rule for further details 
on this modification.
d. Partial QPs
(1) Partial QP Elections Within Virtual Groups
    In the CY 2017 Quality Payment Program final rule, we finalized 
that following a determination that eligible clinicians in an APM 
Entity group in an Advanced APM are Partial QPs for a year, the APM 
Entity will make an election whether to report on applicable measures 
and activities as required under MIPS. If the APM Entity elects to 
report to MIPS, all eligible clinicians in the APM Entity would be 
subject to the MIPS reporting requirements and payment adjustments for 
the relevant year. If the APM Entity elects not to report, all eligible 
clinicians in the APM Entity group will be excluded from the MIPS 
reporting requirements and payment adjustments for the relevant year 
(81 FR 77449).
    We also finalized that in cases where the Partial QP determination 
is made at the individual eligible clinician level, if the individual 
eligible clinician is determined to be a Partial QP, the eligible 
clinician will make the election whether to report on applicable 
measures and activities as required under MIPS and, as a result, be 
subject to the MIPS reporting requirements and payment adjustments (81 
FR 77449). If the individual eligible clinician elects to report to 
MIPS, he or she would be subject to the MIPS reporting requirements and 
payment adjustments for the relevant year. If the individual eligible 
elects not to report to MIPS, he or she will be excluded from the MIPS 
reporting requirements and payment adjustments for the relevant year. 
We also clarified how we consider the absence of an explicit election 
to report to MIPS or to be excluded from MIPS. We finalized that for 
situations in which the APM Entity is responsible for making the 
decision on behalf of all eligible clinicians in the APM Entity group, 
the group of Partial QPs will not be considered MIPS eligible 
clinicians unless the APM Entity opts the group into MIPS 
participation, so that no actions other than the APM Entity's election 
for the group to participate in MIPS would result in MIPS participation 
(81 FR 77449). For eligible clinicians who are determined to be Partial 
QPs individually, we finalized that we will use the eligible 
clinician's actual MIPS reporting activity to determine whether to 
exclude the Partial QP from MIPS in the absence of an explicit 
election. Therefore, if an eligible clinician who is individually 
determined to be a Partial QP submits information to MIPS (not 
including information automatically populated or calculated by CMS on 
the Partial QP's behalf), we will consider the Partial QP to have 
reported, and thus to be participating in MIPS. Likewise, if such an 
individual does not take any action to submit information to MIPS, we 
will consider the Partial QP to have elected to be excluded from MIPS 
(81 FR 77449).
    In the CY 2018 Quality Payment Program final rule, we clarified 
that in the case of an eligible clinician participating in both a 
virtual group and an Advanced APM who has achieved Partial QP status, 
that the eligible clinician would be excluded from the MIPS payment 
adjustment unless the eligible clinician elects to report under MIPS 
(82 FR 53615). However, we incorrectly stated that affirmatively 
agreeing to participate in MIPS as part of a virtual group prior to the 
start of the applicable performance period would constitute an explicit 
election to report under MIPS for all Partial QPs. As such, we also 
incorrectly stated that all eligible clinicians who participate in a 
virtual group and achieve Partial QP status would remain subject to the 
MIPS payment adjustment due to their virtual group election to report 
under MIPS, regardless of their Partial QP election. We note that an 
election made prior to the start of an applicable performance period to 
participate in MIPS as part of a virtual group is separate from an 
election made during the performance period that is warranted as a 
result of an individual eligible clinician or APM Entity achieving 
Partial QP status during the applicable performance period. A virtual 
group election does not equate to an individual eligible clinician or 
APM Entity with a Partial QP status explicitly electing to participate 
in MIPS. In order for an individual eligible clinician or APM Entity 
with a Partial QP status to explicitly elect to participate in MIPS and 
be subject to the MIPS payment adjustment factor, such individual 
eligible clinician or APM Entity would make such election during the 
applicable performance period as a Partial QP status becomes applicable 
and such option for election is warranted. Thus, we are restating that 
affirmatively agreeing to participate in MIPS as part of a virtual 
group prior to the start of the applicable performance period does not 
constitute an explicit election to report under MIPS as it pertains to 
making an explicit election to either report to MIPS or be excluded 
from MIPS for individual eligible clinicians or APM Entities that have 
Partial QP status.
    Related to this clarification, we have proposed in section 
III.H.4.e.(3) of this proposed rule to clarify that beginning with the 
2021 MIPS payment year, when an eligible clinician is determined to be 
a Partial QP for a year at the individual eligible clinician level, the 
individual eligible clinician will make an election whether to report 
to MIPS. If the eligible clinician elects to report

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to MIPS, he or she will be subject to MIPS reporting requirements and 
payment adjustments. If the eligible clinician elects to not report to 
MIPS, he or she will not be subject to MIPS reporting requirements and 
payment adjustments. If the eligible clinician does not make any 
affirmatively election to report to MIPS, he or she will not be subject 
to MIPS reporting requirements and payment adjustments. As a result, 
beginning with the 2021 MIPS payment year, for eligible clinicians who 
are determined to be Partial QPs individually, we will not use the 
eligible clinician's actual MIPS reporting activity to determine 
whether to exclude the Partial QP from MIPS in the absence of an 
explicit election.
    Therefore, the proposed policy in section III.H.4.e.(3) of this 
proposed rule eliminates the scenario in which affirmatively agreeing 
to participate in MIPS as part of a virtual group prior to the start of 
the applicable performance period would constitute an explicit election 
to report under MIPS for eligible clinicians who are determined to be 
Partial QPs individually and make no explicit election to either report 
to MIPS or be excluded from MIPS. We believe this change is necessary 
because QP status and Partial QP status, achieved at the APM Entity 
level or eligible clinician level, is applied to an individual and all 
of his or her TIN/NPI combinations, whereas virtual group participation 
is determined at the TIN level. Therefore, we do not believe that it is 
appropriate that the actions of the TIN in joining the virtual group 
should deprive the eligible clinician who is a Partial QP, whether that 
status was achieved at APM Entity level or eligible clinician level, of 
the opportunity to elect whether or not to opt-in to MIPS.
e. Group Reporting
    We refer readers to Sec.  414.1310(e) and the CY 2018 Quality 
Payment Program final rule (82 FR 53592 through 53593) for a 
description of our previously established policies regarding group 
reporting.
    In the CY 2018 Quality Payment Program final rule (82 FR 53593), we 
clarified that we consider a group to be either an entire single TIN or 
portion of a TIN that: (1) Is participating in MIPS according to the 
generally applicable scoring criteria while the remaining portion of 
the TIN is participating in a MIPS APM or an Advanced APM according to 
the MIPS APM scoring standard; and (2) chooses to participate in MIPS 
at the group level. We would like to further clarify that we consider a 
group to be an entire single TIN that chooses to participate in MIPS at 
the group level. However, individual eligible clinicians (TIN/NPIs) 
within that group may receive a MIPS payment adjustment based on the 
APM scoring standard if they are on the participant list of a MIPS APM. 
We are proposing to amend Sec. Sec.  414.1310(e) and 414.1370(f)(2) to 
codify this policy and more fully reflect the scoring hierarchy as 
discussed in section III.H.3.h.(6) of this proposed rule.
    As discussed in the CY 2018 Quality Payment Program final rule (82 
FR 53593), one of the overarching themes we have heard from 
stakeholders is that we make an option available to groups that would 
allow a portion of a group to report as a separate sub-group on 
measures and activities that are more applicable to the sub-group and 
be assessed and scored accordingly based on the performance of the sub-
group. We stated that in future rulemaking, we intend to explore the 
feasibility of establishing group-related policies that would permit 
participation in MIPS at a sub-group level and create such 
functionality through a new identifier. In the CY 2018 Quality Payment 
Program proposed rule (82 FR 30027), we solicited public comments on 
the ways in which participation in MIPS at the sub-group level could be 
established. In addition, in the CY 2018 Quality Payment Program final 
rule (82 FR 53593), we sought comment on additional ways to define a 
group, not solely based on a TIN. Because there are several operational 
challenges with implementing a sub-group option, we are not proposing 
any such changes to our established reporting policies in this proposed 
rule. Rather, we are considering facilitating the use of a sub-group 
identifier in the Quality Payment Program Year 4 through future 
rulemaking, as necessary. In addition, it has come to our attention 
that providing a sub-group option may provide potential gaming 
opportunities. For example, a group could manipulate scoring by 
creating sub-groups that are comprised of only the high performing 
clinicians in the group. Therefore, we are requesting comment on 
implementing sub-group level reporting through a separate sub-group 
sub-identifier in the Quality Payment Program Year 4 and possibly 
future years of the program. We are specifically requesting comments on 
the following: (1) Whether and how a sub-group should be treated as a 
separate group from the primary group: For example, if there is 1 sub-
group within a group, how would we assess eligibility, performance, 
scoring, and application of the MIPS payment adjustment at the sub-
group level; (2) whether all of the sub-group's MIPS performance data 
should be aggregated with that of the primary group or should be 
treated as a distinct entity for determining the sub-group's final 
score, MIPS payment adjustments, and public reporting, and eligibility 
be determined at the whole group level; (3) possible low burden 
solutions for identification of sub-groups: For example, whether we 
should require registration similar to the CMS Web Interface or a 
similar mechanism to the low-volume threshold opt-in that we are 
proposing in section III.H.3.c.(5) of this proposed rule; and (4) and 
potential issues or solutions needed for sub-groups utilizing 
submission mechanisms, measures, or activities, such as APM 
participation, that are different than the primary group. We also 
welcome comments on other approaches for sub-group reporting that we 
should consider.
f. Virtual Groups
(1) Background
    We refer readers to Sec.  414.1315 and the CY 2018 Quality Payment 
Program final rule (82 FR 53593 through 53617) for our previously 
established policies regarding virtual groups.
(2) Virtual Group Election Process
    We refer readers to Sec.  414.1315(c) and the CY 2018 Quality 
Payment Program final rule (82 FR 53601 through 53604) for our 
previously established policies regarding the virtual group election 
process.
    We are proposing to amend Sec.  414.1315(c) to continue to apply 
the previously established policies regarding the virtual group 
election process for the 2022 MIPS payment year and future years, with 
the exception of the proposed policy modification discussed below.
    Under Sec.  414.1315(c)(2)(ii), an official designated virtual 
group representative must submit an election on behalf of the virtual 
group by December 31 of the calendar year prior to the start of the 
applicable performance period. In the CY 2018 Quality Payment Program 
final rule (82 FR 53603), we stated that such election will occur via 
email to the Quality Payment Program Service Center using the following 
email address for the 2018 and 2019 performance periods: 
[email protected]. Beginning with the 2022 MIPS payment 
year, we propose to amend Sec.  414.1315(c)(2)(ii) to provide that the 
election would occur in a manner specified by CMS. We anticipate that a 
virtual group representative would make an election

[[Page 35892]]

on behalf of a virtual group by registering to participate in MIPS as a 
virtual group via a web-based system developed by CMS. We believe that 
a web-based system would be less burdensome for virtual groups given 
that the interactions stakeholders would have with the Quality Payment 
Program are already conducted via the Quality Payment Program portal, 
and would provide stakeholders with a seamless user experience. 
Stakeholders would be able to make a virtual group election in a 
similar manner to all other interactions with the Quality Payment 
Program portal and would no longer need to separately identify the 
appropriate email address to submit such an election and email an 
election outside of the Quality Payment Program portal. The Quality 
Payment Program portal is the gateway and source for interaction with 
MIPS that contains a range of information on topics including 
eligibility, data submission, and performance reports. We believe that 
using the same web-based platform to make a virtual group election 
would enhance the one-stop MIPS interactive experience and eliminate 
the potential for stakeholders to be unable to identify or erroneously 
enter the email address.
    We solicit public comment on this proposal, which would provide for 
an election to occur in a manner specified by CMS such as a web-based 
system developed by CMS.
(a) Virtual Group Eligibility Determinations
    For purposes of determining TIN size for virtual group 
participation eligibility for the CY 2018 and 2019 performance periods, 
we coined the term ``virtual group eligibility determination period'' 
and defined it to mean an analysis of claims data during an assessment 
period of up to 5 months that would begin on July 1 and end as late as 
November 30 of the calendar year prior to the applicable performance 
period and includes a 30-day claims run out (82 FR 53602). We are 
proposing to modify the virtual group eligibility determination period 
beginning with the 2019 performance period. We propose to amend Sec.  
414.1315(c)(1) to establish a virtual group eligibility determination 
period to mean an analysis of claims data during a 12-month assessment 
period (fiscal year) that would begin on October 1 of the calendar year 
2 years prior to the applicable performance period and end on September 
30 of the calendar year preceding the applicable performance period and 
include a 30-day claims run out. The virtual group eligibility 
determination period aligns with the first segment of data analysis 
under the MIPS eligibility determination period. As part of the virtual 
group eligibility determination period, TINs would be able to inquire 
about their TIN size prior to making an election during a 5-month 
timeframe, which would begin on August 1 and end on December 31 of a 
calendar year prior to the applicable performance period. TIN size 
inquiries would be made through the Quality Payment Program Service 
Center. For TINs that inquire about their TIN size during such 5-month 
timeframe, it should be noted that any TIN size information provided is 
only for informational purposes and may be subject to change; official 
eligibility regarding TIN size and all other eligibility pertaining to 
virtual groups would be determined in accordance with the MIPS 
determination period and other applicable special status eligibility 
determination periods. The proposed modification would provide 
stakeholders with real-time information regarding TIN size for 
informational purposes instead of TIN size eligibility determinations 
on an ongoing basis (between July 1 and November 30 of the calendar 
year prior to the applicable performance period) due to technical 
limitations.
    For the 2018 and 2019 performance periods, TINs could determine 
their status by contacting their designated TA representative as 
provided at Sec.  414.1315(c)(1); otherwise, the TIN's status would be 
determined at the time that the TIN's virtual group election is 
submitted. We propose to amend Sec.  414.1315(c)(1) to remove this 
provision since the inquiry about TIN size would be for informational 
purposes only and may be subject to change.
    We believe that the utilization of the Quality Payment Program 
Service Center, versus the utilization of designated TA 
representatives, as the means for stakeholders to obtain information 
regarding TIN size provides continuity and a seamless experience for 
stakeholders. We note that the TA resources already available to 
stakeholders would continue to be available. The following describes 
the experience a stakeholder would encounter when interacting with the 
Quality Payment Program Service Center to obtain information pertaining 
to TIN size. For example, the applicable performance period for the 
2022 MIPS payment year would be CY 2020. If a group contacted the 
Quality Payment Program Service Center on September 20, 2019, the 
claims data analysis would include the months of October of 2018 
through August of 2019. If another group contacted the Quality Payment 
Program Service Center on November 20, 2019, the claims data analysis 
would include the months of October of 2018 through September of 2019 
with a 30-day claims run out.
    We believe this virtual group eligibility determination period 
provides a real-time representation of TIN size for purposes of 
determining virtual group eligibility and allows solo practitioners and 
groups to know their real-time virtual group eligibility status and 
plan accordingly for virtual group implementation. Beginning with the 
2022 MIPS payment year, it is anticipated that starting in August of 
each calendar year prior to the applicable performance period, solo 
practitioners and groups would be able to contact the Quality Payment 
Program Service Center and inquire about their TIN size. TIN size 
determinations would be based on the number of NPIs associated with a 
TIN, which may include clinicians (NPIs) who do not meet the definition 
of a MIPS eligible clinician at Sec.  414.1305 or who are excluded from 
MIPS under Sec.  414.1310(b) or (c).
    We are proposing to continue to apply the aforementioned previously 
established virtual group policies for the 2022 MIPS payment year and 
future years, with the exception of the following proposed policy 
modifications:
     The virtual group eligibility determination period would 
align with the first segment of the MIPS determination period, which 
includes an analysis of claims data during a 12-month assessment period 
(fiscal year) that would begin on October 1 of the calendar year 2 
years prior to the applicable performance period and end on September 
30 of the calendar year preceding the applicable performance period and 
include a 30-day claims run out. As part of the virtual group 
eligibility determination period, TINs would be able to inquire about 
their TIN size prior to making an election during a 5-month timeframe, 
which would begin on August 1 and end on December 31 of a calendar year 
prior to the applicable performance period.
     MIPS eligible clinicians would be able to contact their 
designated technical assistance representative or, beginning with the 
2022 MIPS payment year, the Quality Payment Program Service Center, as 
applicable, to inquire about their TIN size for informational purposes 
in order to assist MIPS eligible clinicians in determining whether or 
not to participate in MIPS as part of a virtual group. We anticipate 
that starting in August of each calendar year prior to

[[Page 35893]]

the applicable performance period, solo practitioners and groups would 
be able to contact the Quality Payment Program Service Center and 
inquire about virtual group participation eligibility.
     A virtual group representative would make an election on 
behalf of a virtual group by registering to participate in MIPS as a 
virtual group in a form and manner specified by CMS. We anticipate that 
a virtual group representative would make the election via a web-based 
system developed by CMS.
    We are also proposing updates to Sec.  414.1315 in an effort to 
more clearly and concisely capture previously established policies. 
These proposed updates are not intended to be substantive in nature, 
but rather to bring more clarity to the regulatory text.
g. MIPS Performance Period
    In the CY 2018 Quality Payment Program final rule (82 FR 53617 
through 53619), we finalized at Sec.  414.1320(c)(1) that for purposes 
of the 2021 MIPS payment year, the performance period for the quality 
and cost performance categories is CY 2019 (January 1, 2019 through 
December 31, 2019). We did not finalize the performance period for the 
quality and cost performance categories for purposes of the 2022 MIPS 
payment year or future years. We also redesignated Sec.  414.1320(d)(1) 
and finalized at Sec.  414.1320(c)(2) that for purposes of the 2021 
MIPS payment year, the performance period for the Promoting 
Interoperability and improvement activities performance categories is a 
minimum of a continuous 90-day period within CY 2019, up to and 
including the full CY 2019 (January 1, 2019 through December 31, 2019).
    As noted in the CY 2018 Quality Payment Program final rule, we 
received comments that were not supportive of a full calendar year 
performance period for the quality and cost performance categories. 
However, we continue to believe that a full calendar year performance 
period for the quality and cost performance categories will be less 
confusing for MIPS eligible clinicians. Further, a longer performance 
period for the quality and cost performance categories will likely 
include more patient encounters, which will increase the denominator of 
the quality and cost measures. Statistically, larger sample sizes 
provide more accurate and actionable information. Additionally, a full 
calendar year performance period is consistent with how many of the 
measures used in our program were designed to be performed and 
reported. We also note that the Bipartisan Budget Act of 2018 (Pub. L. 
115-119, enacted on February 9, 2018) has provided further flexibility 
to the third, fourth, and fifth years to which MIPS applies to help 
continue the gradual transition to MIPS.
    Regarding the Promoting Interoperability performance category, we 
have heard from stakeholders through public comments, letters, and 
listening sessions that they oppose a full year performance period, 
indicating that it is very challenging and may add administrative 
burdens. Some stated that a 90-day performance period is necessary in 
order to enable clinicians to have a greater focus on the objectives 
and measures that promote patient safety, support clinical 
effectiveness, and drive toward advanced use of health IT. They also 
noted that as this category requires the use of CEHRT, a 90-day 
performance period will help relieve pressure on clinicians to quickly 
implement changes and updates from their CEHRT vendors and developers 
so that patient care is not compromised. Others cited the challenges 
associated with reporting on a full calendar year for clinicians newly 
employed by a health system or practice during the course of a program 
year, switching CEHRT, vendor issues, system downtime, cyber-attacks, 
difficulty getting data from old places of employment, and office 
relocation. Most stakeholders stated that the performance period should 
be 90 days in perpetuity, as this would greatly reduce the reporting 
burden.
    In an effort to provide as much transparency as possible so that 
MIPS eligible clinicians and groups can plan for participation in the 
program, we request comments on our proposals at Sec.  414.1320(d)(1) 
that for purposes of the 2022 MIPS payment year and future years, the 
performance period for the quality and cost performance categories 
would be the full calendar year (January 1 through December 31) that 
occurs 2 years prior to the applicable MIPS payment year. For example, 
for the 2022 MIPS payment year, the performance period would be 2020 
(January 1, 2020 through December 31, 2020), and for the 2023 MIPS 
payment year, the performance period would be CY 2021 (January 1, 2021 
through December 31, 2021).
    We request comments on our proposal at Sec.  414.1320(d)(2) that 
for purposes of the 2022 MIPS payment year and future years, the 
performance period for the improvement activities performance category 
would be a minimum of a continuous 90-day period within the calendar 
year that occurs 2 years prior to the applicable MIPS payment year, up 
to and including the full calendar year. For example, for the 2022 MIPS 
payment year, the performance period for the improvement activities 
performance category would be a minimum of a continuous 90-day period 
within CY 2020, up to and including the full CY 2020 (January 1, 2020 
through December 31, 2020). For the 2023 MIPS payment year, the 
performance period for the improvement activities performance category 
would be a minimum of a continuous 90-day period within CY 2021, up to 
and including the full CY 2021 (January 1, 2021 through December 31, 
2021) that occurs 2 years before the MIPS payment year.
    In addition, we request comments on our proposal to add Sec.  
414.1320(e)(1) that for purposes of the 2022 MIPS payment year, the 
performance period for the Promoting Interoperability performance 
category would be a minimum of a continuous 90-day period within the 
calendar year that occurs 2 years prior to the applicable MIPS payment 
year, up to and including the full calendar year. Thus, for the 2022 
MIPS payment year, the performance period for the Promoting 
Interoperability performance category would be a minimum of a 
continuous 90-day period within CY 2020, up to and including the full 
CY 2020 (January 1, 2020 through December 31, 2020).
h. MIPS Performance Category Measures and Activities
(1) Performance Category Measures and Reporting
(a) Background
    We refer readers to Sec.  414.1325 and the CY 2017 and CY 2018 
Quality Payment Program final rules (81 FR 77087 through 77095, and 82 
FR 53619 through 53626, respectively) for our previously established 
policies regarding data submission requirements.
(b) Collection Types, Submission Types and Submitter Types
    It has come to our attention that the way we have previously 
described data submission by MIPS eligible clinicians, groups and third 
party intermediaries does not precisely reflect the experience users 
have when submitting data to us. To clarify, we have previously used 
the term ``submission mechanisms'' to refer not only to the mechanism 
by which data is submitted, but also to certain types of measures and 
activities on which data are submitted (for example, electronic 
clinical quality measures (eCQMs) reported via EHR) and to the entities 
submitting such data (for example, third party intermediaries on behalf 
of MIPS eligible clinicians and groups). To ensure clarity and 
precision

[[Page 35894]]

for all users, we are proposing to revise existing and define 
additional terminology to more precisely reflect the experience users 
have when submitting data to the Quality Payment Program.
    At Sec.  414.1305, we propose to define the following terms:
     Collection type as a set of quality measures with 
comparable specifications and data completeness criteria, including, as 
applicable: eCQMs; MIPS Clinical Quality Measures (MIPS CQMs); QCDR 
measures; Medicare Part B claims measures; CMS Web Interface measures; 
the CAHPS for MIPS survey; and administrative claims measures. The term 
MIPS CQMs would replace what was formerly referred to as registry 
measures since entities other than registries may submit data on these 
measures. These new terms are referenced in the collection type field 
for the following measure tables of the appendices in this proposed 
rule: Table Group A: Proposed New Quality Measures for Inclusion in 
MIPS for the 2021 MIPS Payment Year and Future Years; Table Group B: 
Proposed New and Modified MIPS Specialty Measure Sets for the 2021 MIPS 
Payment Year and Future Years; Table C: Quality Measures Proposed for 
Removal from the Merit-Based Incentive Payment System Program for the 
2019 Performance Period and Future Years; and Table Group D: Measures 
with Substantive Changes Proposed for the 2021 MIPS Payment Year and 
Future Years.
     Submitter type as the MIPS eligible clinician, group, or 
third party intermediary acting on behalf of a MIPS eligible clinician 
or group, as applicable, that submits data on measures and activities 
under MIPS.
     Submission type as the mechanism by which a submitter type 
submits data to CMS, including, as applicable: Direct, log in and 
upload, log in and attest, Medicare Part B claims and the CMS Web 
Interface. The direct submission type allows users to transmit data 
through a computer-to-computer interaction, such as an API. The log in 
and upload submission type allows users to upload and submit data in 
the form and manner specified by CMS with a set of authenticated 
credentials. The log in and attest submission type allows users to 
manually attest that certain measures and activities were performed in 
the form and manner specified by CMS with a set of authenticated 
credentials. We note that there is no submission type for the 
administrative claims collection type because we calculate measures for 
this collection type based on administrative claims data available to 
us.
    We solicit additional feedback and alternative suggestions on 
terminology that appropriately reflects the concepts described in the 
proposed definitions of collection type, submitter type and submission 
type, as well as the term MIPS CQMs to replace the formerly used term 
of registry measures.
    We previously finalized at Sec.  414.1325(a) and (e), respectively, 
that MIPS eligible clinicians and groups must submit measures, 
objectives, and activities for the quality, improvement activities, and 
advancing care information performance categories and that there are no 
data submission requirements for the cost performance category and for 
certain quality measures used to assess performance in the quality 
performance category; CMS will calculate performance on these measures 
using administrative claims data. We propose to amend Sec.  414.1325(a) 
to incorporate Sec.  414.1325(e), as they both address which 
performance categories require data submission; Sec.  414.1325(f) would 
be redesignated as Sec.  414.1325(e). We also propose at Sec.  
414.1325(a)(2)(ii) that there is no data submission requirement for the 
quality or cost performance category, as applicable, for MIPS eligible 
clinicians and groups that are scored under the facility-based 
measurement scoring methodology described in Sec.  414.1380(e). We also 
recognize the need to clarify to users how they submit data to us. 
There are five basic submission types that we are proposing to define 
in MIPS: Direct; log in and upload; login and attest; Medicare Part B 
claims; and the CMS Web Interface. We are proposing to reorganize Sec.  
414.1325(b) and (c) by performance category. We are proposing to 
clarify at Sec.  414.1325(b)(1) that an individual MIPS eligible 
clinician may submit their MIPS data for the quality performance 
category using the direct, login and upload, and Medicare Part B claims 
submission types. Similarly, we are proposing to clarify at Sec.  
414.1325(b)(2) that an individual MIPS eligible clinician may submit 
their MIPS data for the improvement activities or Promoting 
Interoperability performance categories using the direct, login and 
upload, or login and attest submission types. As for groups, we propose 
to clarify at Sec.  414.1325(c)(1) that groups may submit their MIPS 
data for the quality performance category using the direct, login and 
upload, and CMS Web Interface (for groups consisting of 25 or more 
eligible clinicians) submission types. Lastly, we propose to clarify at 
Sec.  414.1325(c)(2) that groups may submit their MIPS data for the 
improvement activities or Promoting Interoperability performance 
categories using the direct, login and upload, or login and attest 
submission types. We believe that these clarifications will enhance the 
submission experience for clinicians and other stakeholders. As 
technology continues to evolve, we will continue to look for new ways 
that we can offer further technical flexibilities on submitting data to 
the Quality Payment Program. We request comment on these proposals. To 
assist commenters in providing pertinent comments, we have developed a 
website that uses wireframe (schematic) drawings to illustrate a subset 
of the different submission types available for MIPS participation. 
Specifically, the wireframe drawings describe the direct, login and 
attest, and login and upload submission types. We refer readers to the 
Quality Payment Program at qpp.cms.gov/design-examples to review these 
wireframe drawings. The website will provide specific matrices 
illustrating potential stakeholder experiences when choosing to submit 
data under MIPS.
    As previously expressed in the 2017 Quality Payment Program final 
rule (81 FR 77090), we want to move away from claims reporting, since 
approximately 69 percent of the Medicare Part B claims measures are 
topped out. While we would like to move towards the utilization of 
electronic reporting by all clinicians and groups, we realize that 
small practices face additional challenges, and this requirement may 
limit their ability to participate. For this reason, we believe that 
Medicare Part B claims measures should be available to small practices, 
regardless of whether they are reporting an individual MIPS eligible 
clinicians or as groups. Therefore, we propose amending Sec.  
414.1325(c)(1) to make the Medicare Part B claims collection type 
available to MIPS eligible clinicians in small practices beginning with 
the 2021 MIPS payment year. While this would limit the current 
availability of Medicare Part B claims measures for individual MIPS 
eligible clinicians, it would expand the availability of such measures 
for groups, which currently do not have any claims-based reporting 
option.
    Under Sec.  414.1325(c)(4), we previously finalized that groups may 
submit their MIPS data using the CMS Web Interface (for groups 
consisting of 25 or more eligible clinicians) for the quality, 
improvement activities, and promoting interoperability performance 
categories. We are proposing that the CMS Web Interface submission type 
would no longer be available for groups to use to submit data for the 
improvement activities and Promoting Interoperability

[[Page 35895]]

performance categories at Sec.  414.1325(c)(2). The CMS Web Interface 
has been designed based on user feedback as a method for quality 
submissions only; however, groups that elect to utilize the CMS Web 
Interface can still submit improvement activities or promoting 
interoperability data via direct, log in and attest or log in and 
upload submission types. We also recognize that certain groups that 
have elected to use the CMS Web Interface may prefer to have their data 
submitted on their behalf by a third party intermediary described at 
Sec.  414.1400(a). We recognize the benefit and burden reduction in 
such a flexibility and therefore propose to allow third party 
intermediaries to submit data to the CMS Web Interface in addition to 
groups. Specifically, we propose to redesignate Sec.  414.1325(c)(4) as 
Sec.  414.1325(c)(1) and amend Sec.  414.1325(c)(1) to allow third 
party intermediaries to submit data using the CMS Web Interface on 
behalf of groups. To further our efforts to provide flexibility in 
reporting to the Quality Payment Program, we are soliciting comment on 
expanding the CMS Web Interface submission type to groups consisting of 
16 or more eligible clinicians to inform our future rulemaking.
    We previously finalized at Sec.  414.1325(e) that there are no data 
submission requirements for the cost performance category and for 
certain quality measures used to assess performance in the quality 
performance category and that CMS will calculate performance on these 
measures using administrative claims data. We also finalized at Sec.  
414.1325(f)(2), (which, as noted, we are proposing to redesignate as 
Sec.  414.1325(e)(2)) that for Medicare Part B claims, data must be 
submitted on claims with dates of service during the performance period 
that must be processed no later than 60 days following the close of the 
performance period. We neglected to codify this requirement at Sec.  
414.1325(e) (which, as noted, we are proposing to consolidate with 
Sec.  414.1325(a)) for administrative claims data used to assess 
performance in the cost performance category and for administrative 
claims-based quality measures. Therefore, we propose to amend Sec.  
414.1325(a)(2)(i) to reflect that claims included in the measures are 
those submitted with dates of service during the performance period 
that are processed no later than 60 days following the close of the 
performance period.
    A summary of these proposed changes is included in Tables 29 and 
30. For reference, Table 29 summarizes the data submission types for 
individual MIPS eligible clinicians that we are proposing at Sec.  
414.1325(b) and (e). Table 30 summarizes the data submission types for 
groups that we are proposing at Sec.  414.1325(c) and (e). We request 
comment on these proposals.

              Table 29--Data Submission Types for MIPS Eligible Clinicians Reporting as Individuals
----------------------------------------------------------------------------------------------------------------
   Performance category/submission
        combinations accepted              Submission type           Submitter type          Collection type
----------------------------------------------------------------------------------------------------------------
Quality..............................  Direct.................  Individual or Third      eCQMs.
                                       Log in and upload......   Party Intermediary \2\. MIPS CQMs.
                                                                                         QCDR measures.
                                       Medicare Part B claims   Individual.............  Medicare Part B claims
                                        (small practices) \1\.                            measures (small
                                                                                          practices).
Cost.................................  No data submission       Individual.............
                                        required \2\.
Promoting Interoperability...........  Direct.................  Individual or Third
                                       Log in and upload......   Party Intermediary.
                                       Log in and attest......
Improvement Activities...............  Direct.................  Individual or Third
                                       Log in and upload......   Party Intermediary.
                                       Log in and attest......
----------------------------------------------------------------------------------------------------------------
\1\ Third party intermediary does not apply to Medicare Part B claims submission type.
\2\ Requires no separate data submission to CMS: Measures are calculated based on data available from MIPS
  eligible clinicians' billings on Medicare claims.
Note: As used in this proposed rule, the term ``Medicare Part B claims'' differs from ``administrative claims''
  in that ``Medicare Part B claims'' require MIPS eligible clinicians to append certain billing codes to
  denominator-eligible claims to indicate the required quality action or exclusion occurred.


                Table 30--Data Submission Types for MIPS Eligible Clinicians Reporting as Groups
----------------------------------------------------------------------------------------------------------------
   Performance category/submission
        combinations accepted              Submission types          Submitter type          Collection type
----------------------------------------------------------------------------------------------------------------
Quality..............................  Direct.................  Group or Third Party     eCQMs.
                                       Log in and upload......   Intermediary.           MIPS CQMs.
                                       CMS Web Interface                                 QCDR measures.
                                        (groups of 25 or more                            CMS Web Interface
                                        eligible clinicians).                             measures.
                                       Medicare Part B claims                            Medicare Part B claims
                                        (small practices) \1\.                            measures (small
                                                                                          practices).
                                                                                         CMS approved survey
                                                                                          vendor measure.
                                                                                         Administrative claims
                                                                                          measures.
Cost.................................  No data submission       Group..................
                                        required 1 2.
Promoting Interoperability...........  Direct.................  Group or Third Party
                                       Log in and upload......   Intermediary.
                                       Log in and attest......

[[Page 35896]]

 
Improvement Activities...............  Direct.................  Group or Third Party
                                       Log in and upload......   Intermediary.
                                       Log in and attest......
----------------------------------------------------------------------------------------------------------------
\1\ Third party intermediary does not apply to Medicare Part B claims submission type.
\2\ Requires no separate data submission to CMS: Measures are calculated based on data available from MIPS
  eligible clinicians' billings on Medicare claims. Note: As used in this proposed rule, the term ``Medicare
  Part B claims'' differs from ``administrative claims'' in that ``Medicare Part B claims'' require MIPS
  eligible clinicians to append certain billing codes to denominator-eligible claims to indicate the required
  quality action or exclusion occurred.

(c) Submission Deadlines
    We previously finalized data submission deadlines in the CY 2017 
Quality Payment Program final rule (81 FR 77095 through 77097) at Sec.  
414.1325(f), which outlined data submission deadlines for all 
submission mechanisms for individual eligible clinicians and groups for 
all performance categories. As discussed in section III.H.3.h.(1) of 
this proposed rule, the term submission mechanism, that includes 
submission via the qualified registry, QCDR, EHR, Medicare Part B 
claims, the CMS Web Interface and attestation, does not align with the 
existing process of data submission to the Quality Payment Program. We 
are proposing to revise regulatory text language at Sec.  414.1325(f), 
which, as noted, we are proposing to redesignate as Sec.  414.1325(e), 
to outline data submission deadlines for all submission types for 
individual eligible clinicians and groups for all performance 
categories. We also propose to revise Sec.  414.1325(e)(1) to allow 
flexibility for CMS to alter submission deadlines for the direct, login 
and upload, the CMS Web Interface, and login and attest submission 
types. We anticipate that in scenarios where the March 31st deadline 
falls on a weekend or holiday, we would extend the submission period to 
the next business day (that is, Monday). There also may be instances 
where due to unforeseen technical issues, the submission system may be 
inaccessible for a period of time. If this scenario were to occur, we 
anticipate that we would extend the submission period to account for 
this lost time, to the extent feasible. We note that this revision 
would also revise the previously finalized policy at Sec.  
414.1325(e)(3) stating that data must be submitted during an 8-week 
period following the close of the performance period, and that the 
period must begin no earlier than January 2 and end no later than March 
31 for the CMS Web Interface. We are proposing to align the deadline 
for the CMS Web Interface submission type with all other submission 
type deadlines at Sec.  414.1325(e)(1), while we are also proposing to 
remove the previously finalized policy at Sec.  414.1325(e)(3) because 
it is no longer needed to mandate a different submission deadline for 
the CMS Web Interface submission type.
    We are also proposing a number of other technical revisions to 
Sec.  414.1325 to more clearly and concisely reflect previously 
established policies.
(2) Quality Performance Category
(a) Background
    We refer readers to Sec. Sec.  414.1330 through 414.1340 and the CY 
2018 Quality Payment Program final rule (82 FR 53626 through 53641) for 
our previously established policies regarding the quality performance 
category.
(i) Assessing Performance on the Quality Performance Category
    Under Sec.  414.1330(a), for purposes of assessing performance of 
MIPS eligible clinicians on the quality performance category, we will 
use: Quality measures included in the MIPS final list of quality 
measures and quality measures used by QCDRs. We are proposing to amend 
Sec.  414.1330(a) to account for facility-based measurement and the APM 
scoring standard. For that reason, we are proposing Sec.  414.1330(a) 
to specify, for a MIPS payment year, we use the following quality 
measures, as applicable, to assess performance in the quality 
performance category: Measures included in the MIPS final list of 
quality measures established by us through rulemaking; QCDR measures 
approved by us under Sec.  414.1440; facility-based measures as 
described under Sec.  414.1380; and MIPS APM measures as described at 
Sec.  414.1370.
(ii) Contribution to Final Score
    Under Sec.  414.1330(b)(2) and (3), performance in the quality 
performance category will comprise 50 percent of a MIPS eligible 
clinician's final score for the 2020 MIPS payment year and 30 percent 
of a MIPS eligible clinician's final score for each MIPS payment year 
thereafter. Section 1848(q)(5)(E)(i)(I) of the Act, as amended by 
section 51003(a)(1)(C)(i) of the Bipartisan Budget Act of 2018, 
provides that 30 percent of the final score shall be based on 
performance with respect to the quality performance category, but that 
for each of the first through fifth years for which MIPS applies to 
payments, the quality performance category performance percentage shall 
be increased so that the total percentage points of the increase equals 
the total number of percentage points by which the cost performance 
category performance percentage is less than 30 percent for the 
respective year. As discussed in section III.H.3.i.(c) of this proposed 
rule, we are proposing to weight the cost performance category at 15 
percent for the 2021 MIPS payment year. Accordingly, we are proposing 
to amend Sec.  414.1330(b)(2) to provide that performance in the 
quality performance category will comprise 50 percent of a MIPS 
eligible clinician's final score for the 2020 MIPS payment year, and 
propose at Sec.  414.1330(b)(3) that the quality performance category 
comprises 45 percent of a MIPS eligible clinician's final score for the 
2021 MIPS payment year.
(iii) Quality Data Submission Criteria
(A) Submission Criteria
(aa) Submission Criteria for Groups Reporting Quality Measures, 
Excluding CMS Web Interface Measures and the CAHPS for MIPS Survey 
Measure
    We refer readers to Sec.  414.1335(a)(1) for our previously 
established submission criteria for quality measures submitted via 
claims, registry, QCDR, or EHR. In section III.H.3.h. of this proposed 
rule, we propose revisions to existing and additional terminology to 
clarify the data submission processes available for MIPS eligible 
clinicians, groups and third party intermediaries, to align with the 
way users actually submit data to the Quality Payment Program. For that 
reason, we are proposing to revise Sec.  414.1335(a)(1) to

[[Page 35897]]

state that data would be collected for the following collection types: 
Medicare Part B claims measures; MIPS CQMs; eCQMs, or QCDR measures. 
Codified at Sec.  414.1335(a)(1)(i), MIPS eligible clinicians and 
groups must submit data on at least six measures including at least one 
outcome measure. If an applicable outcome measure is not available, 
report one other high priority measure. If fewer than six measures 
apply to the MIPS eligible clinician or group, report on each measure 
that is applicable. Furthermore, we are proposing beginning with the 
2021 MIPS payment year to revise Sec.  414.1335(a)(1)(ii) to indicate 
that MIPS eligible clinicians and groups that report on a specialty or 
subspecialty measure set, must submit data on at least six measures 
within that set, provided the set contain at least six measures. If the 
set contains fewer than six measures or if fewer than six measures 
apply to the MIPS eligible clinician or group, report on each measure 
that is applicable.
    As previously expressed in the 2017 Quality Payment Program final 
rule (81 FR 77090), we want to move away from claims reporting, since 
approximately 69 percent of the Medicare Part B claims measures are 
topped out. As discussed in section III.H.3.h. of this proposed rule, 
we are proposing to limit the Medicare Part B claims submission type, 
and therefore, the Medicare Part B claims measures, to MIPS eligible 
clinicians in small practices. We refer readers to section III.H.3.h of 
this proposed rule for discussion of this proposal.
(bb) Submission Criteria for Groups Reporting CMS Web Interface 
Measures
    While we are not proposing any changes to the established 
submission criteria for CMS Web Interface measures at Sec.  
414.1335(a)(2), beginning with the 2021 MIPS payment year, we are 
proposing to revise the terminology in which CMS Web Interface measures 
are referenced-to align with the updated submission terminology as 
discussed in section III.H.3.h of this proposed rule. Therefore, we 
propose to revise Sec.  414.1335(a)(2) from via the CMS Web Interface-
for groups consisting of 25 or more eligible clinicians only, to for 
CMS Web Interface measures.
    In order to ensure that the collection of information is valuable 
to clinicians and worth the cost and burden of collecting information, 
and address the challenge of fragmented reporting for multiple measures 
and submission options, we seek comment on expanding the CMS Web 
Interface option to groups with 16 or more eligible clinicians. 
Preliminary analysis has indicated that expanding the CMS Web Interface 
option to groups of 16 or more eligible clinicians will likely result 
in many of these new groups not being able fully satisfy measure case 
minimums on multiple CMS Web Interface measures. However, we can 
possibly mitigate this issue if we require smaller groups (with 16-24 
eligible clinicians) to report on only a subset of the CMS Web 
Interface measures, such as the preventive care measures. We are 
interested in stakeholder feedback on the issue of expanding the CMS 
Web interface to groups of 16 or more, as well as other factors we 
should consider with such expansion.
    As discussed in section III.F.1.c. of the Medicare Shared Savings 
Program portion of this proposed rule, changes proposed and finalized 
through rulemaking to the CMS Web Interface measures for MIPS would be 
applicable to ACO quality reporting under the Shared Savings Program. 
In Table Group D: Measures with Substantive Changes Proposed for the 
2021 MIPS Payment Year and Future Years of the measures appendix, we 
are proposing to remove 6 measures from the CMS Web Interface in MIPS. 
If finalized, groups reporting CMS Web Interface measures for MIPS 
would not be responsible for reporting those removed measures. We refer 
readers to the quality measure appendix for additional details on the 
proposals related to changes in CMS Web Interface measures.
    As discussed in the CY 2017 Quality Payment Program final rule (81 
FR 77116), the CMS Web Interface has a two-step attribution process 
that associates beneficiaries with TINs during the period in which 
performance is assessed (adopted from the Physician Value-based Payment 
Modifier (VM) program). The CAHPS for MIPS survey utilizes the same 
two-step attribution process as the CMS Web Interface. The CY 2017 
Quality Payment Program final rule (81 FR 77116) noted that attribution 
would be conducted using the different identifiers in MIPS. For 
purposes of the CMS Web Interface and the CAHPS for MIPS survey, we 
clarify that attribution would be conducted at the TIN level.
(cc) Submission Criteria for Groups Electing To Report Consumer 
Assessment of Healthcare Providers and Systems (CAHPS) for MIPS Survey
    While we are not proposing any changes to the established 
submission criteria for the CAHPS for MIPS Survey at Sec.  
414.1335(a)(3), beginning with the 2021 MIPS payment year, we are 
proposing to revise Sec.  414.1335(a)(3) to clarify that for the CAHPS 
for MIPS survey, for the 12-month performance period, a group that 
wishes to voluntarily elect to participate in the CAHPS for MIPS survey 
measure must use a survey vendor that is approved by CMS for the 
applicable performance period to transmit survey measure data to us.
(B) Summary of Data Submission Criteria
    We are not proposing any changes to the quality data submission 
criteria for the 2021 MIPS payment year in this proposed rule; however, 
as discussed in section III.H.3.h. of this proposed rule, we are 
proposing changes to existing and additional submission related 
terminology. Similarly, while we are not proposing changes to the data 
completeness criteria at Sec.  414.1340, we are proposing to changes to 
existing and additional submission related terminology. For that 
reason, we are proposing to revise Sec.  414.1340 to specify that MIPS 
eligible clinicians and groups submitting quality measures data on QCDR 
measures, MIPS CQMs, or the eCQMs must submit data on at least 60 
percent of the MIPS eligible clinician or group's patients that meet 
the measure's denominator criteria, regardless of payer for MIPS 
payment year 2021; MIPS eligible clinicians and groups submitting 
quality measure data on the Medicare Part B claims measures must submit 
data on at least 60 percent of the applicable Medicare Part B patients 
seen during the performance period to which the measure applies for the 
2021 MIPS payment year; and groups submitting quality measures data on 
CMS Web Interface measures or the CAHPS for MIPS survey measure, must 
meet the data submission requirement on the sample of the Medicare Part 
B patients CMS provides. Below, we have included Tables 31 and 32 to 
clearly capture the data completeness requirements and submission 
criteria by collection type for individual clinicians and groups.

[[Page 35898]]



   Table 31--Summary of Data Completeness Requirements and Performance
   Period by Collection Type for the 2020 and 2021 MIPS Payment Years
------------------------------------------------------------------------
                                   Performance
        Collection type               period         Data completeness
------------------------------------------------------------------------
Medicare Part B claims          Jan 1-Dec 31 (or   60 percent of
 measures.                       90 days for        individual MIPS
                                 selected           eligible
                                 measures).         clinician's, or
                                                    group's (beginning
                                                    with the 2021 MIPS
                                                    payment year)
                                                    Medicare Part B
                                                    patients for the
                                                    performance period.
Administrative claims measures  Jan 1-Dec 31.....  100 percent of
                                                    individual MIPS
                                                    eligible clinician's
                                                    Medicare Part B
                                                    patients for the
                                                    performance period.
QCDR measures, MIPS CQMs, and   Jan 1-Dec 31 (or   60 percent of
 eCQMs.                          90 days for        individual MIPS
                                 selected           eligible
                                 measures).         clinician's, or
                                                    group's patients
                                                    across all payers
                                                    for the performance
                                                    period.
CMS Web Interface measures....  Jan 1-Dec 31.....  Sampling requirements
                                                    for the group's
                                                    Medicare Part B
                                                    patients: Populate
                                                    data fields for the
                                                    first 248
                                                    consecutively ranked
                                                    and assigned
                                                    Medicare
                                                    beneficiaries in the
                                                    order in which they
                                                    appear in the
                                                    group's sample for
                                                    each module/measure.
                                                    If the pool of
                                                    eligible assigned
                                                    beneficiaries is
                                                    less than 248, then
                                                    the group would
                                                    report on 100
                                                    percent of assigned
                                                    beneficiaries.
CAHPS for MIPS survey.........  Jan 1-Dec 31.....  Sampling requirements
                                                    for the group's
                                                    Medicare Part B
                                                    patients.
------------------------------------------------------------------------


 Table 32--Summary of Quality Data Submission Criteria for MIPS Payment
             Year 2021 for Individual Clinicians and Groups
------------------------------------------------------------------------
                                                     Measure collection
       Clinician type          Submission criteria    types (or measure
                                                       sets) available
------------------------------------------------------------------------
Individual Clinicians.......  Report at least six   Individual MIPS
                               measures including    eligible clinicians
                               one outcome           select their
                               measure, or if an     measures from the
                               outcome measure is    following
                               not available         collection types:
                               report another high   Medicare Part B
                               priority measure;     claims measures
                               if less than six      (individual
                               measures apply then   clinicians in small
                               report on each        practices only),
                               measure that is       MIPS CQMs, QCDR
                               applicable.           measures, eCQMs, or
                               Clinicians would      reports on one of
                               need to meet the      the specialty
                               applicable data       measure sets if
                               completeness          applicable.
                               standard for the
                               applicable
                               performance period
                               for each collection
                               type.
Groups (non-CMS Web           Report at least six   Groups select their
 Interface).                   measures including    measures from the
                               one outcome           following
                               measure, or if an     collection types:
                               outcome measure is    Medicare Part B
                               not available         claims measures
                               report another high   (small practices
                               priority measure;     only), MIPS CQMs,
                               if less than six      QCDR measures,
                               measures apply then   eCQMs, or the CAHPS
                               report on each        for MIPS survey--or
                               measure that is       reports on one of
                               applicable.           the specialty
                               Clinicians would      measure sets if
                               need to meet the      applicable.
                               applicable data      Groups of 16 or more
                               completeness          clinicians who meet
                               standard for the      the case minimum of
                               applicable            200 will also be
                               performance period    automatically
                               for each collection   scored on the
                               type.                 administrative
                                                     claims based all-
                                                     cause hospital
                                                     readmission
                                                     measure.
Groups (CMS Web Interface     Report on all         Groups report on all
 for group of at least 25      measures includes     measures included
 clinicians).                  in the CMS Web        in the CMS Web
                               Interface             Interface measures
                               collection type and   collection type and
                               optionally the        optionally the
                               CAHPS for MIPS        CAHPS for MIPS
                               survey.               survey.
                              Clinicians would      Groups of 16 or more
                               need to meet the      clinicians who meet
                               applicable data       the case minimum of
                               completeness          200 will also be
                               standard for the      automatically
                               applicable            scored on the
                               performance period    administrative
                               for each collection   claims based all-
                               type.                 cause hospital
                                                     readmission
                                                     measure.
------------------------------------------------------------------------

(iv) Application of Facility-Based Measures
    According to section 1848(q)(2)(C)(ii) of the Act, the Secretary 
may use measures for payment systems other than for physicians, such as 
measures used for inpatient hospitals, for purposes of the quality and 
cost performance categories. However, the Secretary may not use 
measures for hospital outpatient departments, except in the case of 
items and services furnished by emergency physicians, radiologists, and 
anesthesiologists. We refer readers to section III.H.3.i.(1)(d) of this 
proposed rule, Facility-Based Measures Scoring Option for the 2021 MIPS 
Payment Year for the Quality and Cost Performance Categories, for full 
discussion of facility-based measures and scoring for the 2021 MIPS 
payment year.
(b) Selection of MIPS Quality Measures for Individual MIPS Eligible 
Clinicians and Groups Under the Annual List of Quality Measures 
Available for MIPS Assessment
(i) Background and Policies for the Call for Measures and Measure 
Selection Process
    In the CY 2017 Quality Payment Program final rule (81 FR 77153), we 
established that we would categorize measures into the six NQS domains 
(patient safety, person-and caregiver-centered experience and outcomes, 
communication and care coordination, effective clinical care, 
community/population health, and efficiency and cost reduction). To 
streamline quality measures, reduce regulatory burden, and promote 
innovation, we have developed and announced our Meaningful Measures 
Initiative.\16\ By identifying the highest priority areas for quality 
measurement and quality improvement, the Meaning Measures Initiative, 
identifies the core quality of care issues that advances our work to 
improve patient outcomes. Through subregulatory guidance, we will 
categorize quality measures by the 19 Meaningful Measure areas as 
identified on the Meaningful Measures Initiative website at https://
www.cms.gov/Medicare/Quality-Initiatives-Patient-

[[Page 35899]]

Assessment-Instruments/QualityInitiativesGenInfo/MMF/General-info-Sub-
Page.html. The categorization of quality measures by Meaningful Measure 
area would provide MIPS eligible clinicians and groups with guidance as 
to how each measure fits into the framework of the Meaningful Measure 
Initiative.
---------------------------------------------------------------------------

    \16\ Link to Meaningful Measures web page on CMS site to be 
provided at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/MMF/General-info-Sub-Page.html.
---------------------------------------------------------------------------

    Furthermore, under Sec.  414.1305, a high priority measure is 
defined as an outcome, appropriate use, patient safety, efficiency, 
patient experience or care coordination quality measure. Due to the 
immense impact of the opioid epidemic across the United States, we 
believe it is imperative to promote the measurement of opioid use and 
overuse, risks, monitoring, and education through quality reporting. 
For that reason, beginning with the 2019 performance period, we are 
proposing at Sec.  414.1305 to amend the definition of a high priority 
measure, to include quality measures that relate to opioids and to 
further clarify the types of outcome measures that are considered high 
priority. Beginning with the 2021 MIPS payment year, we are proposing 
to define at Sec.  414.1305 a high priority measure to mean an outcome, 
appropriate use, patient safety, efficiency, patient experience, care 
coordination, or opioid-related quality measure. Outcome measures would 
include intermediate-outcome and patient-reported outcome measures. We 
request comment on this proposal, specifically if stakeholders have 
suggestions on what aspects of opioids should be measured. For example, 
should we focus solely on opioid overuse?
    Previously finalized MIPS quality measures can be found in the CY 
2018 Quality Payment Program final rule (82 FR 53966 through 54174) and 
in the CY 2017 Quality Payment Program final rule (81 FR 77558 through 
77816). The new MIPS quality measures proposed for inclusion in MIPS 
for the 2019 performance period and future years are found in Table A 
of Appendix 1: Proposed MIPS Quality Measures of this proposed rule. 
The current specialty measure sets can be found in the CY 2018 Quality 
Payment Program final rule (82 FR 53976 through 54146). The proposed 
new and modified quality measure specialty sets can be found in Table B 
of Appendix 1: Proposed MIPS Quality Measures of this proposed rule, 
and include new proposed measures, previously finalized measures with 
proposed modifications, and previously finalized measures with no 
proposed modifications.
    We note that modifications made to the specialty sets may include 
the removal of certain previously finalized quality measures. Certain 
MIPS specialty sets have further defined subspecialty sets, each of 
which constitutes a separate specialty set. In instances where an 
individual MIPS eligible clinician or group reports on a specialty or 
subspecialty set, if the set has less than six measures, that is all 
the clinician is required to report. MIPS eligible clinicians are not 
required to report on the specialty measure sets, but they are 
suggested measures for specific specialties. Please note that the 
proposed specialty and subspecialty sets are not inclusive of every 
specialty or subspecialty.
    On January 9, 2018,\17\ we announced that we would be accepting 
recommendations for potential new specialty measure sets for Year 3 of 
MIPS under the Quality Payment Program. These recommendations were 
based on the MIPS quality measures finalized in the CY 2018 Quality 
Payment Program final rule, and includes recommendations to add or 
remove the current MIPS quality measures from the specialty measure 
sets. All specialty measure set recommendations submitted for 
consideration were assessed to ensure that they meet the needs of the 
Quality Payment Program.
---------------------------------------------------------------------------

    \17\ Listserv messaging was distributed through the Quality 
Payment Program listserv on January 9th, 2018, titled: ``CMS is 
Soliciting Stakeholder Recommendations for Potential Consideration 
of New Specialty Measure Sets and/or Revisions to the Existing 
Specialty Measure Sets for the 2019 Program Year of Merit-based 
Incentive Payment System (MIPS).''
---------------------------------------------------------------------------

    In the CY 2017 Quality Payment Program final rule (81 FR 77137), we 
finalized that substantive changes to MIPS quality measures, to include 
but are not limited to, measures that have had measure specification 
changes, measure title changes, or domain changes. MIPS quality 
measures with proposed substantive changes can be found in Table D of 
Appendix 1: Proposed MIPS Quality Measures of this proposed rule.
    With regards to eCQMs, in the 2015 EHR Incentive Program final 
rule, CMS required eligible clinicians, eligible hospitals, and 
critical access hospitals (CAHs) to use the most recent version of an 
eCQM for electronic reporting beginning in 2017 (80 FR 62893). We are 
proposing this policy for the end-to-end electronic reporting bonus 
under MIPS and encourage MIPS eligible clinicians to work with their 
EHR vendors to ensure they have the most recent version of the eCQM. 
CMS will not accept an older version of an eCQM as a submission for the 
MIPS program for the quality performance category or the end-to-end 
electronic reporting bonus within that category. MIPS eligible 
clinicians and groups reporting on the quality performance category are 
required to use the most recent version of the eCQM specifications. The 
annual updates to the eCQM specifications and any applicable addenda 
are available on the electronic quality improvement (eCQI) Resource 
Center website at https://ecqi.healthit.gov for the applicable 
performance period. Furthermore, as discussed in section III.E. of this 
proposed rule, the Medicaid Promoting Interoperability Program intends 
to utilize eCQM measures as they are available in MIPS. We refer 
readers to section III.E. of this proposed rule for additional details 
and criteria on the Medicaid Promoting Interoperability Program.
    In MIPS, there are a limited number of CMS Web Interface measures, 
we seek comment on building upon the CMS Web Interface submission type 
by expanding the core set of measures available for that submission 
type to include other specialty specific measures (such as surgery).
    To provide clinicians with a more cohesive reporting experience, 
where they may focus on activities and measures that are meaningful to 
their scope of practice, we discuss the development of public health 
priority measurement sets that would include measures and activities 
across the quality, Promoting Interoperability, and improvement 
activities performance categories, focused on public health priorities 
such as fighting the opioid epidemic, in section III.H.3.h.(5), 
Promoting Interoperability. We refer readers to section III.H.3.h.(5) 
of this proposed rule for additional details on this concept.
(ii) Topped Out Measures
    In the CY 2018 Quality Payment Program final rule (82 FR 53637 
through 53640), we finalized the 4-year timeline to identify topped out 
measures, after which we may propose to remove the measures through 
future rulemaking. After a measure has been identified as topped out 
for 3 consecutive years through the benchmarks, we may propose to 
remove the measure through notice and comment rulemaking. Therefore, in 
the 4th year, if finalized through rulemaking, the measure would be 
removed and would no longer be available for reporting during the 
performance period. We refer readers to the 2018 MIPS Quality 
Benchmarks' file, that is located on the Quality Payment Program 
resource library (https://www.cms.gov/Medicare/

[[Page 35900]]

Quality-Payment-Program/Resource-Library/Resource-library.html) to 
determine which measure benchmarks are topped out for 2018 and would be 
subject to the cap if they are also topped out in the 2019 MIPS Quality 
Benchmarks' file. It should be noted that the final determination of 
which measure benchmarks are subject to the topped out cap would not be 
available until the 2019 MIPS Quality Benchmarks' file is released in 
late 2018.
    We are proposing that once a measure has reached an extremely 
topped out status (for example, a measure with an average mean 
performance within the 98th to 100th percentile range), we may propose 
the measure for removal in the next rulemaking cycle, regardless of 
whether or not it is in the midst of the topped out measure lifecycle, 
due to the extremely high and unvarying performance where meaningful 
distinctions and improvement in performance can no longer be made, 
after taking into account any other relevant factors. We are concerned 
that topped out non-high priority process measures require data 
collection burden without added value for eligible clinicians and 
groups participating in MIPS. It is important to remove these types of 
measures, so that available measures provide meaningful value to 
clinicians collecting data, beneficiaries, and the program. However, we 
would also consider retaining the measure if there are compelling 
reasons as to why it should not be removed (for example, if the removal 
would impact the number of measures available to a specialist type or 
if the measure addressed an area of importance to the Agency).
    Since QCDR measures are not approved or removed from MIPS through 
the rulemaking timeline or cycle, we are proposing to exclude QCDR 
measures from the topped out timeline that was finalized in the CY 2018 
Quality Payment Program final rule (82 FR 53640). When a QCDR measure 
reaches topped out status, as determined during the QCDR measure 
approval process, it may not be approved as a QCDR measure for the 
applicable performance period. Because QCDRs have more flexibility to 
develop innovative measures, we believe there is limited value in 
maintaining topped out QCDR measures in MIPS.
(iii) Removal of Quality Measures
    In the CY 2017 Quality Payment Program final rule (81 FR 77136 
through 77137), we discussed removal criteria for quality measures, 
including that a quality measure may be considered for removal if the 
Secretary determines that the measure is no longer meaningful, such as 
measures that are topped out. Furthermore, if a measure steward is no 
longer able to maintain the quality measure, it would also be 
considered for removal.
    We have previously communicated to stakeholders our desire to 
reduce the number of process measures within the MIPS quality measure 
set. In the CY 2017 Quality Payment Program final rule (81 FR 77101), 
we explained that we believe that outcome measures are more valuable 
than clinical process measures and are instrumental to improving the 
quality of care patients receive. In the CY 2018 Quality Payment 
Program quality measure set, 102 of the 275 quality measures are 
process measures that are not considered high priority. As discussed 
above, beginning with the 2021 MIPS payment year, we are proposing to 
define at Sec.  414.1305 a high priority measure to mean an outcome, 
appropriate use, patient safety, efficiency, patient experience, care 
coordination, or opioid-related quality measure. Because the removal of 
all non-high priority process measures would impact most specialty 
sets, nearly 94 percent, we believe incrementally removing non-high 
priority process measures through notice and comment rulemaking is 
appropriate.
    Beginning with the 2019 performance period, we propose to implement 
an approach to incrementally remove process measures where prior to 
removal, considerations will be given to, but is not limited to:
     Whether the removal of the process measure impacts the 
number of measures available for a specific specialty.
     Whether the measure addresses a priority area highlighted 
in the Measure Development Plan: https://www.cms.gov/Medicare/Quality-Payment-Program/Measure-Development/Measure-development.html.
     Whether the measure promotes positive outcomes in 
patients.
     Considerations and evaluation of the measure's performance 
data.
     Whether the measure is designated as high priority or not.
     Whether the measure has reached a topped out status within 
the 98th to 100th percentile range, due to the extremely high and 
unvarying performance where meaningful distinctions and improvement in 
performance can no longer be made, as described in the proposal in the 
above topped out measures section.
(iv) Categorizing Measures by Value
    In outlining the various types of MIPS quality and QCDR measures 
available for reporting in the quality performance category, such as 
outcome, high-priority, composite, and process measures, we acknowledge 
that not all measures are created equal. For example, the value or 
information gained by reporting on certain process measures does not 
equate that which is collected on outcome measures. We seek to ensure 
that the collection and submission of data is valuable to clinicians 
and worth the cost and burden of collecting the information.
    Based on this, we seek comment on implementing a system where 
measures are classified as a particular value (gold, silver or bronze) 
and points are awarded based on the value of the measure. For example, 
higher value measures that are considered ``gold'' standard, which 
could include outcome measures, composite measures, or measures that 
address agency priorities (such as opioids). The CAHPS for MIPS survey, 
which collects patient experience data, may also be considered a high 
value measure. Measures that are considered second tier, or at a 
``silver'' standard would be measures that are considered process 
measures that are directly related to outcomes and have a good gap in 
performance (there is no high, unwavering performance) and demonstrate 
room for improvement; or topped out outcome measures. Lower value 
measures, such as standard of care process measures or topped out 
process measures would be considered ``bronze'' measures. We refer 
readers to section III.H.3.i. (1)(b)(xi) of this proposed rule for 
discussion on the assignment of value and scoring based on measure 
value.
(3) Cost Performance Category
    For a description of the statutory basis and our existing policies 
for the cost performance category, we refer readers to the CY 2017 and 
CY 2018 Quality Payment Program final rule (81 FR 77162 through 77177, 
and 82 FR 53641 through 53648, respectively).
(a) Weight in the Final Score
    In the CY 2018 Quality Payment Program final rule, we established 
that the weight of the cost performance category would be 10 percent of 
the final score for the 2020 MIPS payment year (82 FR 53643). We had 
previously finalized in the CY 2017 Quality Payment Program final rule 
at Sec.  414.1350(b)(3) that beginning with the 2021 MIPS payment year, 
the cost performance category would be 30

[[Page 35901]]

percent of the final score, as required by section 
1848(q)(5)(E)(i)(II)(aa) of the Act (81 FR 77166). Section 
51003(a)(1)(C) of the Bipartisan Budget Act of 2018, enacted on 
February 9, 2018, amended section 1848(q)(5)(E)(i)(II)(bb) of the Act 
such that for each of the second, third, fourth, and fifth years for 
which the MIPS applies to payments, not less than 10 percent and not 
more than 30 percent of the MIPS final score shall be based on the cost 
performance category score. Additionally, this provision shall not be 
construed as preventing the Secretary from adopting a 30 percent weight 
if the Secretary determines, based on information posted under section 
1848(r)(2)(I) of the Act, that sufficient cost measures are ready for 
adoption for use under the cost performance category for the relevant 
performance period. Section 51003(a)(2) of the Bipartisan Budget Act of 
2018 amended section 1848(r)(2) of the Act to add a new paragraph (I), 
which we discuss in section III.H.3.h.(3)(b)(i) of this proposed rule.
    In light of these amendments, we propose at Sec.  414.1350(d)(3) 
the cost performance category would make up 15 percent of a MIPS 
eligible clinician's final score for the 2021 MIPS payment year. As 
discussed in section III.H.3.h.(3)(b)(iv) of this proposed rule, we are 
proposing to codify the existing policies for the attribution of cost 
measures, which would result in redesignating Sec.  414.1350(b) as 
Sec.  414.1350(d). We propose to delete the existing text under Sec.  
414.1350(b)(3) and address the weight of the cost performance category 
for the MIPS payment years following 2021 in future rulemaking. We also 
propose a technical change to the text at Sec.  414.1350(b) 
(redesignated as Sec.  414.1350(d)) to state that the cost performance 
category weight will be as specified under redesignated Sec.  
414.1350(d), unless a different scoring weight is assigned by CMS under 
section 1848(q)(5)(F) of the Act.
    We believe that measuring cost is an integral part of measuring 
value, and we believe that clinicians have a significant impact on the 
costs of patient care. However, we are proposing to only modestly 
increase the weight of the cost performance category for the 2021 MIPS 
payment year from the 2020 MIPS payment year because we recognize that 
cost measures are still relatively early in the process of development 
and that clinicians do not have the level of familiarity or 
understanding of cost measures that they do of comparable quality 
measures. As described in section III.H.3.h.(3)(b)(ii) of this proposed 
rule, we are proposing to add 8 episode-based measures to the cost 
performance category beginning with the 2019 MIPS performance period. 
This is a first step in developing a more robust and clinician-focused 
measurement of cost performance. We will continue to work on developing 
additional episode-based measures that we may consider proposing for 
the cost performance category in future years. Introducing more 
measures over time would allow for more clinicians to be measured in 
this performance category. It would also allow time for more outreach 
to clinicians to better educate them on the cost measures. We 
considered maintaining the weight of the cost performance category at 
10 percent for the 2021 MIPS payment year as we recognize that 
clinicians are still learning about the cost performance category and 
being introduced to new measures. We invite comment on whether we 
should consider an alternative weight for the 2021 MIPS payment year.
    In accordance with section 1848(q)(5)(E)(i)(II)(bb) of the Act, we 
will continue to evaluate whether sufficient cost measures are ready 
for adoption under the cost performance category and move towards the 
goal of increasing the weight to 30 percent of the final score. To 
provide for a smooth transition, we anticipate that we would increase 
the weight of the cost performance category by 5 percentage points each 
year until we reach the required 30 percent weight for the 2024 MIPS 
payment year. We invite comments on this approach to the weight of the 
cost performance category for the 2022 and 2023 MIPS payment years, 
considering our flexibility in setting the weight between 10 percent 
and 30 percent of the final score, the availability of cost measures, 
and our desire to ensure a smooth transition to a 30 percent weight for 
the cost performance category.
(b) Cost Criteria
(i) Background
    Under Sec.  414.1350(a), we specify cost measures for a performance 
period to assess the performance of MIPS eligible clinicians on the 
cost performance category. In the CY 2018 Quality Payment Program final 
rule, we established two cost measures (total per capita cost measure 
and Medicare spending per beneficiary (MSPB) measure) for the 2018 MIPS 
performance period and future performance periods (82 FR 53644). These 
measures were previously established for the 2017 MIPS performance 
period (81 FR 77168). We will continue to evaluate cost measures that 
are included in MIPS on a regular basis and anticipate that measures 
could be added or removed through rulemaking as measure development 
continues. In general, we expect to evaluate cost measures according to 
the measure reevaluation and maintenance processes outlined in the 
``Blueprint for the CMS Measures Management System'' (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Blueprint-130.pdf). As described in section 2 
of the Blueprint for the CMS Measures Management System Version 13.0, 
we will conduct annual evaluations to review the continued accuracy of 
the measure specifications. Annual updates ensure that the procedure, 
diagnostic, and other codes used in the measure account for updates to 
coding systems over time. To the extent that these updates would 
constitute a substantive change to a measure, we would ensure the 
changes are proposed for adoption through rulemaking. We will also 
comprehensively reevaluate the measures every 3 years to ensure that 
they continue to meet measure priorities. As a part of this 
comprehensive reevaluation, we will gather information through 
environmental scans and literature reviews of recent studies and new 
clinical guidelines that may inform potential refinements. We will also 
analyze measure performance rates and re-assess the reliability and 
validity of the measures. Throughout these reevaluation efforts, we 
will summarize and consider all stakeholder feedback received on the 
measure specifications during the implementation process, and may seek 
input through public comment periods. In addition, the measure 
development contractor may acquire individual input on measures by 
convening Technical Expert Panels (TEPs) and clinical subcommittees. 
Aside from these regular measure reevaluations, there may be ad-hoc 
reviews of the measures if new evidence comes to light which indicates 
that significant revisions may be required.
    We will also continue to update the specifications to address 
changes in coding, risk adjustment, and other factors. The process for 
updating measure specifications will take place through ongoing 
maintenance and evaluation, during which we expect to continue seeking 
stakeholder input. As we noted above, any substantive changes to a 
measure would be proposed for adoption in future years through notice 
and comment

[[Page 35902]]

rulemaking. We appreciate the feedback that we have received so far 
throughout the measure development process and believe that 
stakeholders will continue to provide feedback to the measure 
development contractor on episode-based cost measures by submitting 
written comments during public comment opportunities, by participating 
in the clinical subcommittees convened by the measure development 
contractor, or by attending education and outreach events. We will take 
all comments and feedback into consideration as part of the ongoing 
measure evaluation process.
    As we noted in the CY 2017 Quality Payment Program final rule (81 
FR 77137) regarding quality measures, which we believe would also apply 
for cost measures, some updates may incorporate changes that would not 
substantively change the intent of the measure. Examples of such 
changes may include updated diagnosis or procedure codes or changes to 
exclusions to the patient population or definitions. While we address 
such changes on a case-by-case basis, we generally believe these types 
of maintenance changes are distinct from substantive changes to 
measures that result in what are considered new or different measures. 
As described in section 3 of the Blueprint for the CMS Measures 
Management System Version 13.0, if substantive changes to these 
measures become necessary, we expect to follow the pre-rulemaking 
process for new measures, including resubmission to the Measures Under 
Consideration (MUC) list and consideration by the Measure Applications 
Partnership (MAP). The MAP provides an additional opportunity for an 
interdisciplinary group of stakeholders to provide feedback on whether 
they believe the measures under consideration are attributable and 
applicable to clinicians. The MAP also reviews measures for clinician 
level feasibility, reliability, and validity. They also consider 
whether the measures are scientifically acceptable, and reflect current 
clinical guidelines.
    Section 51003(a)(2) of the Bipartisan Budget Act of 2018 amended 
section 1848(r)(2) of the Act to add a new paragraph (I) requiring the 
Secretary to post on the CMS website information on cost measures in 
use under MIPS, cost measures under development and the time-frame for 
such development, potential future cost measure topics, a description 
of stakeholder engagement, and the percent of expenditures under 
Medicare Part A and Part B that are covered by cost measures. This 
information shall be posted no later than December 31 of each year 
beginning with 2018. We expect this posting will provide a list of the 
cost measures established for the cost performance category for the 
current performance period (for example, the posting in 2018 would 
include a list of the measures for the 2018 MIPS performance period), 
as well as a list of any cost measures that may be proposed for a 
future performance period through rulemaking. We will provide 
hyperlinks to the measure specifications documents, and include the 
percent of Medicare Part A and Part B expenditures that are covered by 
these cost measures. The posting will also include a list and 
description of the measures under development at that time. We intend 
to summarize the timeline for measure development, including the 
stakeholder engagement activities undertaken, which may include a TEP, 
clinical subcommittees, field testing, and education and outreach 
activities, such as national provider calls and listening sessions. 
Finally, the posting will provide an overview of potential future 
topics in cost measure development, such as any clinical areas in which 
measures may be developed in the future.
(ii) Episode-Based Measures Proposed for the 2019 and Future 
Performance Periods
    Episode-based measures differ from the total per capita cost 
measure and MSPB measure because episode-based measure specifications 
only include items and services that are related to the episode of care 
for a clinical condition or procedure (as defined by procedure and 
diagnosis codes), as opposed to including all services that are 
provided to a patient over a given timeframe.
    We discussed our progress in the development of episode-based 
measures in the CY 2018 Quality Payment Program proposed rule (82 FR 
30049 through 30050) and received significant positive feedback on the 
process used to develop the measures as well as the measures' clinical 
focus that was informed by expert opinion (82 FR 53644 through 53646). 
The specific measures selected for the initial round of field testing 
were included based on the volume of beneficiaries impacted by the 
condition or procedure, the share of cost to Medicare impacted by the 
condition or procedure, the number of clinicians/clinician groups 
attributed, and the potential for alignment with existing quality 
measures.
    We have developed episode-based measures to represent the cost to 
Medicare for the items and services furnished to a patient during an 
episode of care (``episode''). Episode-based measures are developed to 
let attributed clinicians know the cost of the care clinically related 
to their initial treatment of a patient and provided during the 
episode's timeframe. Specifically, we define cost based on the allowed 
amounts on Medicare claims, which include both Medicare payments and 
beneficiary deductible and coinsurance amounts. Episode-based measures 
are calculated using Medicare Parts A and B fee-for-service claims data 
and are based on episode groups. Episode groups:
     Represent a clinically cohesive set of medical services 
rendered to treat a given medical condition.
     Aggregate all items and services provided for a defined 
patient cohort to assess the total cost of care.
     Are defined around treatment for a condition (acute or 
chronic) or performance of a procedure.
    Items and services in the episode group could be treatment 
services, diagnostic services, and ancillary items and services 
directly related to treatment (such as anesthesia for a surgical 
procedure). They could also be items and services that occur after the 
initial treatment period that may be furnished to patients as follow-up 
care or to treat complications resulting from the treatment. An episode 
is a specific instance of an episode group for a specific patient and 
clinician. For example, in a given year, a clinician might be 
attributed 20 episodes (instances of the episode group) from the 
episode group for heart failure. In section III.H.3.h.(3)(b)(iv) of 
this proposed rule, we discuss the attribution rules for cost measures.
    After episodes are attributed to one or more clinicians, items and 
services may be included in the episode costs if they are furnished 
within a patient's episode window. Items and services will be included 
if they are the trigger event for the episode or if a service 
assignment rule identifies them as a clinically related item or service 
during the episode. The detailed specifications for these measures, 
which include information about the service assignment rule, can be 
reviewed at qpp.cms.gov.
    To ensure a more accurate comparison of cost across clinicians, 
episode costs are payment standardized and risk adjusted. Payment 
standardization adjusts the allowed amount for an item or service to 
facilitate cost comparisons and limit observed differences in costs to 
those that may result from health care delivery choices. Payment 
standardized costs remove any Medicare payment differences due to 
adjustments for

[[Page 35903]]

geographic differences in wage levels or policy-driven payment 
adjustments such as those for teaching hospitals. Risk adjustment 
accounts for patient characteristics that can influence spending and 
are outside of clinician control. For example, for the elective 
outpatient PCI episode-based measure, the risk adjustment model may 
account for a patient's history of heart failure.
    The measure development contractor has continued to seek extensive 
stakeholder feedback on the development of episode-based measures, 
building on the processes outlined in the CY 2018 Quality Payment 
Program final rule (82 FR 53644). These processes included convening a 
TEP and clinical subcommittees to solicit expert and clinical input for 
measure development, conducting national field testing on the episode-
based cost measures developed, and seeking input from clinicians and 
stakeholders through engagement activities. Seven clinical 
subcommittees were convened through an open call for nominations 
between March 17, 2017 and April 24, 2017, composed of nearly 150 
clinicians affiliated with almost 100 specialty societies. These 
subcommittees met at an in-person meeting and through webinars from May 
2017 to January 2018 to select an episode group or groups to develop 
and provide detailed clinical input on each component of episode-based 
cost measures. These components included episode triggers and windows, 
item and service assignment, exclusions, attribution methodology, and 
risk adjustment variables.
    As described in the CY 2018 Quality Payment Program final rule (82 
FR 53645), we provided an initial opportunity for clinicians to review 
their performance based on the new episode-based measures developed by 
the clinical subcommittees in the fall of 2017 through national field 
testing. During the period of October 16, 2017 to November 20, 2017, 
solo practitioners and clinician groups were able to access field test 
reports about their cost measure performance on the CMS Enterprise 
Portal if they were attributed at least 10 episodes for at least one of 
these eight measures during the measurement period of June 1, 2016 to 
May 31, 2017. In addition to the field test reports, stakeholders could 
review a range of materials about the new episode-based cost measures, 
including a fact sheet, frequently asked questions (FAQ) document, a 
mock field test report, and draft measure specifications for each of 
the 8 new episode-based measures (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/Episode-based-cost-measures-field-test-zip-files.zip).
    During field testing, we sought feedback from stakeholders on the 
draft measure specifications, feedback report format, and supplemental 
documentation through an online form. We received over 200 responses, 
including 53 comment letters, during the field test feedback period. We 
shared the feedback on the draft measure specifications with the 
clinical subcommittees who considered it in providing input on measure 
refinements after the end of field testing. A field testing feedback 
summary report is publicly available at qpp.cms.gov.
    To engage clinicians and stakeholders, we conducted extensive 
outreach activities including hosting National Provider Calls (NPCs) to 
provide information about the measure development process and field 
test reports, and to give stakeholders the opportunity to ask 
questions.
    The new episode-based measures developed by the clinical 
subcommittees were considered by the NQF-convened MAP, and were all 
conditionally supported by the MAP, with the recommendation of 
obtaining NQF endorsement. We intend to submit these episode-based 
measures to NQF for endorsement in the future. The MAP provides an 
opportunity for an interdisciplinary group of stakeholders to provide 
input on whether the measures under consideration are attributable and 
applicable to clinicians. The MAP also reviews measures for clinician 
level feasibility, reliability, and validity. Following the successful 
field testing and review through the MAP process, we propose to add 8 
episode-based measures listed in Table 33 as cost measures for the 2019 
MIPS performance period and future performance periods.
    The attribution methodology for these measures is discussed in 
section III.H.3.h.(3)(b)(iv)(B) of this proposed rule. The detailed 
specifications for these measures can be reviewed at qpp.cms.gov. These 
specifications documents consist of (i) a methods document that 
outlines the methodology for constructing the measures, and (ii) a 
measure codes list file that contains the medical codes used in that 
methodology. First, the methods document provides a high-level overview 
of the measure development process, including discussion of the 
detailed clinical input obtained at each step, and details about the 
components of episode-based cost measures: Defining an episode group; 
assigning costs to the episode group; attributing the episode group; 
risk adjusting episode group costs; and aligning cost with quality. The 
methods document also contains the detailed measure methodology that 
describes each logic step involved in constructing the episode groups 
and calculating the cost measure. Second, the measure codes list file 
contains the codes used in the specifications, including the episode 
triggers, exclusions, episode sub-groups, assigned items and services, 
and risk adjustors.

 Table 33--Episode-Based Measures Proposed for the 2019 MIPS Performance
                  Period and Future Performance Periods
------------------------------------------------------------------------
        Measure topic                         Measure type
------------------------------------------------------------------------
Elective Outpatient            Procedural.
 Percutaneous Coronary
 Intervention (PCI).
Knee Arthroplasty............  Procedural.
Revascularization for Lower    Procedural.
 Extremity Chronic Critical
 Limb Ischemia.
Routine Cataract Removal with  Procedural.
 Intraocular Lens (IOL)
 Implantation.
Screening/Surveillance         Procedural.
 Colonoscopy.
Intracranial Hemorrhage or     Acute inpatient medical condition.
 Cerebral Infarction.
Simple Pneumonia with          Acute inpatient medical condition.
 Hospitalization.
ST-Elevation Myocardial        Acute inpatient medical condition.
 Infarction (STEMI) with
 Percutaneous Coronary
 Intervention (PCI).
------------------------------------------------------------------------


[[Page 35904]]

(iii) Reliability
    In the CY 2017 Quality Payment Program final rule (81 FR 77169 
through 77170), we finalized a reliability threshold of 0.4 for 
measures in the cost performance category. We seek to ensure that MIPS 
eligible clinicians are measured reliably. In the CY 2017 Quality 
Payment Program final rule, we finalized a case minimum of 20 for the 
episode-based measures specified for the 2017 MIPS performance period 
(81 FR 77175). We examined the reliability of the proposed 8 episode-
based measures listed in Table 33 at various case minimums and found 
that all of these measures meet the reliability threshold of 0.4 for 
the majority of clinicians and groups at a case minimum of 10 episodes 
for procedural episode-based measures and 20 episodes for acute 
inpatient medical condition episode-based measures. Furthermore, these 
case minimums would balance the goal of increased reliability with the 
goal of adopting cost measures that are applicable to a larger set of 
clinicians and clinician groups. Our analysis indicated that the case 
minimum for procedural episode-based measures could be lower than that 
of acute inpatient medical condition episode-based measures while still 
ensuring reliable measures.
    Table 34 presents the percentage of TINs and TIN/NPIs with 0.4 or 
higher reliability, as well as the mean reliability for the subset of 
TINs and TIN/NPIs who met the proposed case minimums of 10 episodes for 
procedural episode-based measures and 20 episodes for acute inpatient 
medical condition episode-based measures for each of the proposed 
episode-based measures. Each row in this table provides the percentage 
of TINs and TIN/NPIs who had reliability of 0.4 or higher among all the 
TINs and TIN/NPIs who met the case minimum for that measure during the 
study period (6/1/2016 to 5/31/2017).

  Table 34--Percentage of TINs and TIN/NPIs With 0.4 or Higher Reliability From June 1, 2016 to May 31, 2017 at
                                             Proposed Case Minimums
----------------------------------------------------------------------------------------------------------------
                                                    Percentage                      Percentage
                                                   TINs with 0.4       Mean       TIN/NPIs  with       Mean
                  Measure name                       or higher      reliability   0.4  or higher    reliability
                                                    reliability      for TINs       reliability    for TIN/NPIs
----------------------------------------------------------------------------------------------------------------
Elective Outpatient Percutaneous Coronary                  100.0            0.73            84.1            0.53
 Intervention (PCI).............................
Knee Arthroplasty...............................           100.0            0.87           100.0            0.81
Revascularization for Lower Extremity Chronic              100.0            0.74           100.0            0.64
 Critical Limb Ischemia.........................
Routine Cataract Removal with Intraocular Lens             100.0            0.95           100.0            0.94
 (IOL) Implantation.............................
Screening/Surveillance Colonoscopy..............           100.0            0.96           100.0            0.93
Intracranial Hemorrhage or Cerebral Infarction..           100.0            0.70            74.9            0.48
Simple Pneumonia with Hospitalization...........           100.0            0.64            31.8            0.40
ST-Elevation Myocardial Infarction (STEMI) with            100.0            0.59           100.0            0.59
 PCI............................................
----------------------------------------------------------------------------------------------------------------

    Based on this analysis, we propose at Sec.  414.1350(c)(4) and (5) 
a case minimum of 10 episodes for the procedural episode-based measures 
and 20 episodes for the acute inpatient medical condition episode-based 
measures that we have proposed beginning with the 2019 MIPS performance 
period. These case minimums would ensure that the measures meet the 
reliability threshold for groups and individual clinicians. We believe 
that the proposed case minimums for these procedural and acute 
inpatient medical condition episode-based measures would achieve a 
balance between several important considerations. In order to help 
clinicians become familiar with the episode-based measures as a robust 
and clinician-focused form of cost measurement, we want to provide as 
many clinicians as possible the opportunity to receive information 
about their performance on reliable measures. This is consistent with 
the stakeholder feedback that we have received throughout the measure 
development process. We believe that calculating episode-based measures 
with these case minimums would accurately and reliably measure the 
performance of a large number of clinicians and clinician group 
practices.
    We recognize that the percentage of TIN/NPIs with 0.4 or greater 
reliability for the Simple Pneumonia with Hospitalization measure, 
while still meeting our reliability threshold, is somewhat lower than 
that of the other proposed acute inpatient medical condition episode-
based measures, as well as all of the proposed procedural episode-based 
measures. For this reason, we considered an alternative case minimum of 
30 for both TIN/NPIs and TINs for this measure. At this case minimum, 
100 percent of TIN/NPIs would have 0.4 or greater reliability and the 
mean reliability would increase to 0.49 for TIN/NPIs and 0.70 for TINs. 
However, the number of TINs and TIN/NPIs that would meet the case 
minimum for this important measure would decrease by 29 percent for 
TINs and by 84 percent for TIN/NPIs. We invite comments on this 
alternative case minimum for TIN/NPIs and TINs for the Simple Pneumonia 
with Hospitalization episode-based measure.
    We previously finalized a case minimum of 35 for the MSPB measure 
(81 FR 77171), 20 for the total per capita cost measure (81 FR 77170), 
and 20 for the episode-based measures specified for the 2017 MIPS 
performance period (81 FR 77175). We propose to codify these final 
policies under Sec.  414.1350(c).
    In general, higher case minimums increase reliability, but also 
decrease the number of clinicians who are measured. We aim to measure 
as many clinicians as possible in the cost performance category. Some 
clinicians or smaller groups may never see enough patients in a single 
year to meet the case minimum for a specific episode-based measure. For 
this reason, we seek comment on whether we should consider expanding 
the performance period for the cost performance category measures from 
a single year to 2 or more years in future rulemaking. We believe this 
would allow us to more reliably measure a larger number of clinicians. 
However, we are also concerned that expanding the performance period 
would increase the time between the measurement of performance and the 
application of the MIPS payment adjustment. In addition, it would take 
a longer period of time for us to introduce new cost measures as we 
would expect to adopt them through rulemaking prior to the beginning of 
the performance period.

[[Page 35905]]

(iv) Attribution
(A) Attribution Methodology for Cost Measures
    In the CY 2017 Quality Payment Program final rule (81 FR 77168 
through 77169; 77174 through 77176), we adopted final policies 
concerning the attribution methodologies for the total per capita cost 
measure, the MSPB measure, and the episode-based measures specified for 
the 2017 MIPS performance period in addition to an attribution 
methodology for individual clinicians and groups. We propose to codify 
these final policies under Sec.  414.1350(b).
(B) Attribution Rules for the Proposed Episode-Based Measures
    In section III.H.3.h.(3)(b)(ii) of this proposed rule, we propose 
to add 8 episode-based measures as cost measures for the 2019 MIPS 
performance period and future performance periods, which can be 
categorized into two types of episode groups: Acute inpatient medical 
condition episode groups, and procedural episode groups. These measures 
only include items and services that are related to the episode of care 
for a clinical condition or procedure (as defined by procedure and 
diagnosis codes), as opposed to including all services that are 
provided to a patient over a given period of time. The attribution 
methodology would be the same for all of the measures within each type 
of episode groups--acute inpatient medical condition episode groups and 
procedural episode groups. Our proposed approach to attribution would 
ensure that the episode-based measures reflect the roles of the 
individuals and groups in providing care to patients.
    For acute inpatient medical condition episode groups specified 
beginning in the 2019 performance period, we propose at Sec.  
414.1350(b)(6) to attribute episodes to each MIPS eligible clinician 
who bills inpatient evaluation and management (E&M) claim lines during 
a trigger inpatient hospitalization under a TIN that renders at least 
30 percent of the inpatient E&M claim lines in that hospitalization. A 
trigger inpatient hospitalization is a hospitalization with a 
particular MS-DRG identifying the episode group. These MS-DRGs, and any 
supplementary trigger rules, are identified in the measure 
specifications posted at qpp.cms.gov. The measure score for an 
individual clinician (TIN/NPI) is based on all of the episodes 
attributed to the individual. The measure score for a group (TIN) is 
based on all of the episodes attributed to a TIN/NPI in the given TIN. 
If a single episode is attributed to multiple TIN/NPIs in a single TIN, 
the episode is only counted once in the TIN's measure score. We believe 
that establishing a 30 percent threshold for the TIN would ensure that 
the clinician group is collectively measured across all of its 
clinicians who are likely responsible for the oversight of care for the 
patient during the trigger hospitalization.
    This proposed attribution approach differs from the attribution 
approach previously established for episode-based measures for acute 
inpatient medical conditions specified for the 2017 performance period 
in the CY 2017 Quality Payment Program final rule (81 FR 77174 through 
77175). The previous approach attributed episodes to TIN/NPIs who 
individually exceed the 30 percent E&M threshold, while excluding all 
episodes where no TIN/NPI exceeds the 30 percent threshold. Throughout 
the measure development process, stakeholders have discussed the team-
based nature of acute care, in which multiple clinicians share 
management of a patient during a hospital stay. The previous approach 
outlined in the CY 2017 Quality Payment Program final rule (81 FR 77174 
through 77175) does not capture patients' episodes when a group 
collaborates to manage a patient but no individual clinician exceeds 
the 30 percent threshold. Based upon stakeholder feedback, our proposed 
approach emphasizes team-based care and expands the measures' coverage 
of clinicians, patients, and cost.
    To illustrate the proposed attribution rules for acute inpatient 
medical condition episode groups, we are providing an example where 3 
MIPS eligible clinicians are part of the same TIN. The TIN bills 50 
percent of total inpatient E&M claim lines during an inpatient 
hospitalization. Clinician A and B each bill 3 inpatient E&M claim 
lines under the TIN, and Clinician C bills none under the TIN. If MIPS 
eligible clinicians under this TIN are scored as individual TIN/NPIs, 
this episode would be attributed to Clinicians A and B, but not 
Clinician C. The episode would be used to calculate Clinician A's 
measure score and Clinician B's measure score, but not Clinician C's. 
The episode would count towards the individual 20 episode case minimums 
for both Clinicians A and B. If this TIN is instead scored as a group, 
the episode would be included in the calculation of the TIN's measure 
score because it has exceeded the 30 percent inpatient E&M threshold. 
This episode would count towards the TIN's 20 episode case minimum. We 
note that this episode would only be counted once towards the TIN's 
score, even though 2 clinicians under the TIN exceeded the 30 percent 
threshold. The previous attribution approach outlined in the CY 2017 
Quality Payment Program final rule (81 FR 77174 through 77175) would 
discard this episode altogether. Specifically, it would not attribute 
this episode to Clinician A, B, or C, in the above example and the 
episode would not be included in these clinicians' measures or their 
TIN's measure.
    For procedural episode groups specified beginning in the 2019 MIPS 
performance period, we propose at Sec.  414.1350(b)(7) to attribute 
episodes to each MIPS eligible clinician who renders a trigger service 
as identified by HCPCS/CPT procedure codes. These trigger services are 
identified in the measure specifications posted at qpp.cms.gov. The 
measure score for an individual clinician (TIN/NPI) is based on all of 
the episodes attributed to the individual. The measure score for a 
group (TIN) is based on all of the episodes attributed to a TIN/NPI in 
the given TIN. If a single episode is attributed to multiple TIN/NPIs 
in a single TIN, the episode is only counted once in the TIN's measure 
score. We believe this approach best identifies the clinician(s) 
responsible for the patient's care. This attribution method is similar 
to that used for procedural episode-based measures in the 2017 MIPS 
performance period but more clearly defines that the services must be 
provided during the episode and how we would address instances in which 
two NPIs in the same TIN provided a trigger service.
(4) Improvement Activities Performance Category
(a) Background
    In CY 2017 Quality Payment Program final rule (81 FR 77179 through 
77180), we codified at Sec.  414.1355 that the improvement activities 
performance category would account for 15 percent of the final score. 
We refer readers to section III.H.3.i.(1)(e) of this proposed rule 
where we are proposing to modify Sec.  414.1355 to provide further 
technical clarifications. In addition, in the CY 2018 Quality Payment 
Program final rule (82 FR 53649), we codified at Sec.  
414.1380(b)(3)(iv) that the term ``recognized'' be accepted as 
equivalent to the term ``certified'' when referring to the requirements 
for a patient-centered medical home to receive full credit for the 
improvement activities performance category for MIPS. We also finalized 
at Sec.  414.1380(b)(3)(x) that for the 2020 MIPS payment year and 
future years, to

[[Page 35906]]

receive full credit as a certified or recognized patient-centered 
medical home or comparable specialty practice, at least 50 percent of 
the practice sites within the TIN must be recognized as a patient-
centered medical home or comparable specialty practice (82 FR 53655). 
We refer readers to section III.H.3.i.(1)(e)(i)(E) of this proposed 
rule for details on our proposals regarding patient-centered medical 
homes.
    In the CY 2017 Quality Payment Program final rule (81 FR 77539), we 
codified the definition of improvement activities at Sec.  414.1305 to 
mean an activity that relevant MIPS eligible clinicians, organizations, 
and other relevant stakeholders identify as improving clinical practice 
or care delivery and that the Secretary determines, when effectively 
executed, is likely to result in improved outcomes. Further, in that 
final rule (81 FR 77190), we codified at Sec.  414.1365 that the 
improvement activities performance category would include the 
subcategories of activities provided at section 1848(q)(2)(B)(iii) of 
the Act. We also codified subcategories for improvement activities at 
Sec.  414.1365 (81 FR 77190).
    We also previously codified in the CY 2017 and CY 2018 Quality 
Payment Program final rules (81 FR 77180 and 82 FR 53651, respectively) 
data submission criteria for the improvement activities performance 
category at Sec.  414.1360(a)(1). In addition, we established 
exceptions for: Small practices; practices located in rural areas; 
practices located in geographic HPSAs; non-patient facing individual 
MIPS eligible clinicians or groups; and individual MIPS eligible 
clinicians and groups that participate in a MIPS APM or a patient-
centered medical home submitting in MIPS (81 FR 77185, 77188). 
Specifically, we codified at Sec.  414.1380(b)(3)(vii) that non-patient 
facing MIPS eligible clinicians and groups, small practices, and 
practices located in rural areas and geographic HPSAs receive full 
credit for the improvement activities performance category by selecting 
one high-weighted improvement activity or two medium-weighted 
improvement activities; such practices receive half credit for the 
improvement activities performance category by selecting one medium-
weighted improvement activity (81 FR 77185). We refer readers to 
section III.H.3.i.(1)(e)(i)(B) of this proposed rule for our proposals 
related to that provision. In addition, we specified at Sec.  414.1305 
that rural areas refers to ZIP codes designated as rural, using the 
most recent HRSA Area Health Resource File data set available (81 FR 
77188, 82 FR 53582). Lastly, we finalized the meaning of Health 
Professional Shortage Areas (HPSA) at Sec.  414.1305 to mean areas as 
designated under section 332(a)(1)(A) of the Public Health Service Act 
(81 FR 77188). In the CY 2018 Quality Payment Program final rule (82 FR 
53581), we modified the definition of small practices at Sec.  414.1305 
to mean practices consisting of 15 or fewer eligible clinicians.
    In this proposed rule, we request comments on our proposals to: (1) 
Revise Sec.  414.1360(a)(1) to more accurately describe the data 
submission criteria; (2) delete Sec.  414.1365 and move improvement 
activities subcategories to Sec.  414.1355(c); (3) update the criteria 
considered for nominating new improvement activities; (4) modify the 
Annual Call for Activities timeline for the CY 2019 performance period 
and future years; (5) add 6 new improvement activities for the CY 2019 
performance period and future years; (6) modify 5 existing improvement 
activities for the CY 2019 performance period and future years; and (7) 
remove 1 existing improvement activity for the CY 2019 performance 
period and future years. In addition, we also request comments on our 
proposals with respect to the CMS Study on Factors Associated with 
Reporting Quality Measures for the CY 2019 performance period and 
future years the following proposals: (1) Change the title of the study 
to ``CMS Study on Factors Associated with Reporting Quality Measures;'' 
(2) increase the sample size to a minimum of 200 participants; (3) 
limit the focus group requirement to a subset of the 200 participants; 
and (4) require that at least one of the minimum of three required 
measures be a high priority measure. We are also making clarifications 
to: (1) Considerations for selecting improvement activities for the CY 
2019 performance period and future years; and (2) the weighting of 
improvement activities.
    These topics are discussed in more detail below.
(b) Submission Criteria
    We refer readers to the CY 2017 Quality Payment Program final rule 
(81 FR 77181) for submission mechanism policies we finalized and 
codified for the transition year of MIPS. In the CY 2018 Quality 
Payment Program final rule (82 FR 53651), we continued these policies 
for future years. Specifically, we finalized that for MIPS Year 2 and 
future years, MIPS eligible clinicians or groups must submit data on 
MIPS improvement activities in one of the following manners: Qualified 
registries; EHR submission mechanisms; QCDR; CMS Web Interface; or 
attestation. Additionally, we finalized that for activities that are 
performed for at least a continuous 90-days during the performance 
period, MIPS eligible clinicians must submit a yes response for 
activities within the improvement activities inventory. In addition, in 
the case where an individual MIPS eligible clinician or group is using 
a health IT vendor, QCDR, or qualified registry for their data 
submission, we finalized that the MIPS eligible clinician or group must 
certify all improvement activities were performed and the health IT 
vendor, QCDR, or qualified registry would submit on their behalf (82 FR 
53650 through 53651). We also updated Sec.  414.1360 to reflect those 
changes (82 FR 53651).
    We refer readers to section III.H.3.h.(1) of this proposed rule, 
MIPS Performance Category Measures and Activities, where we discuss our 
proposals to update the data submission process for MIPS eligible 
clinicians, groups and third party intermediaries, by updating our 
terminology. We also refer readers to proposed changes to Sec.  
414.1325 for Data submission requirements. We are proposing those 
changes to more closely align with the actual submission experience 
users have. In alignment with those proposals, we are requesting 
comments on our proposal to revise Sec.  414.1360(a)(1) to more 
accurately reflect the data submission process for the improvement 
activities performance category. In particular, we are proposing that 
instead of ``via qualified registries; EHR submission mechanisms; QCDR, 
CMS Web Interface; or attestation,'' as currently stated, we are 
revising the first sentence to state that data would be submitted ``via 
direct, login and upload, and login and attest'' as discussed in 
section III.H.3.h.(1)(b) of this proposed rule.
    In addition, we are proposing to add further additions to Sec.  
414.1360(a)(1) to include paragraph (i). In Sec.  414.1360(a)(1), we 
are proposing to specify, submit a yes response for each improvement 
activity that is performed for at least a continuous 90-day period 
during the applicable performance period.
(c) Subcategories
    In the CY 2017 Quality Payment Program final rule (81 FR 77190), we 
finalized at Sec.  414.1365 that the improvement activities performance 
category includes the subcategories of activities provided at section 
1848(q)(2)(B)(iii) of the Act. It has since come to our attention that 
it is unnecessary to have a separate

[[Page 35907]]

regulation text included under Sec.  414.1365 since the subcategories 
are not a component of the scoring calculations. Therefore, we are 
proposing to delete Sec.  414.1365 and move the same improvement 
activities subcategories to Sec.  414.1355(c). We reiterate that we are 
not proposing any changes to the subcategories themselves. These 
subcategories are:
     Expanded practice access, such as same day appointments 
for urgent needs and after-hours access to clinician advice.
     Population management, such as monitoring health 
conditions of individuals to provide timely health care interventions 
or participation in a QCDR.
     Care coordination, such as timely communication of test 
results, timely exchange of clinical information to patients or other 
clinicians, and use of remote monitoring or telehealth.
     Beneficiary engagement, such as the establishment of care 
plans for individuals with complex care needs, beneficiary self-
management assessment and training, and using shared decision making 
mechanisms.
     Patient safety and practice assessment, such as through 
the use of clinical or surgical checklists and practice assessments 
related to maintaining certification.
     Participation in an APM.
     Achieving health equity, such as for MIPS eligible 
clinicians that achieve high quality for underserved populations, 
including persons with behavioral health conditions, racial and ethnic 
minorities, sexual and gender minorities, people with disabilities, 
people living in rural areas, and people in geographic HPSAs.
     Emergency preparedness and response, such as measuring 
MIPS eligible clinician participation in the Medical Reserve Corps, 
measuring registration in the Emergency System for Advance Registration 
of Volunteer Health Professionals, measuring relevant reserve and 
active duty uniformed services MIPS eligible clinician activities, and 
measuring MIPS eligible clinician volunteer participation in domestic 
or international humanitarian medical relief work.
     Integrated behavioral and mental health, such as measuring 
or evaluating such practices as: Co-location of behavioral health and 
primary care services; shared/integrated behavioral health and primary 
care records; cross training of MIPS eligible clinicians, and 
integrating behavioral health with primary care to address substance 
use disorders or other behavioral health conditions, as well as 
integrating mental health with primary care.
(d) Improvement Activities Inventory
    In this section of this proposed rule, we are proposing to: (1) 
Adopt one new criterion and remove one existing criterion for 
nominating new improvement activities beginning with the CY 2019 
performance period and future years; (2) modify the timeframe for the 
Annual Call for Activities; (3) add 6 new improvement activities for 
the CY 2019 performance period and future years; (4) modify 5 existing 
improvement activities for the CY 2019 performance period and future 
years; and (5) remove 1 existing improvement activity for the CY 2019 
performance period and future years. We are also making clarifications 
to: (1) Considerations for selecting improvement activities for the CY 
2019 performance period and future years; and (2) the weighting of 
improvement activities.
(i) Annual Call for Activities
    In the CY 2017 Quality Payment Program final rule (81 FR 77190), 
for the transition year of MIPS, we implemented the initial Improvement 
Activities Inventory and took several steps to ensure it was inclusive 
of activities in line with statutory and program requirements. For Year 
2, we provided an informal process for submitting new improvement 
activities or modifications for potential inclusion in the 
comprehensive Improvement Activities Inventory for the Quality Payment 
Program Year 2 and future years through subregulatory guidance (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Annual-Call-for-Measures-and-Activities-for-MIPS_Overview-Factsheet.pdf). In the CY 2018 Quality Payment Program 
final rule (82 FR 53656 through 53659), for Year 3 and future years, we 
finalized a formal Annual Call for Activities process for adding 
possible new activities or providing modifications to the current 
activities in the Improvement Activities Inventory, including 
information required to submit a nomination form similar to the one we 
utilized for Year 2 (82 FR 53656 through 53659). It is important to 
note that in order to submit a request for a new activity or a 
modification to an existing improvement activity the stakeholder must 
submit a nomination form found at www.qpp.cms.gov during the Annual 
Call for Improvement Activities.
(A) Criteria for Nominating New Improvement Activities
    In this proposed rule, we are proposing to add one new criterion 
and remove a previously adopted criterion from the improvement 
activities nomination criteria. We are also clarifying our 
considerations in selecting improvement activities.
(aa) Currently Adopted Criteria
    In the CY 2017 Quality Payment final rule (81 FR 77190 
through77195), we discussed guidelines for the selection of improvement 
activities. In the CY 2018 Quality Payment Program final rule, we 
formalized the Annual Call for Activities process for Year 3 and future 
years and added additional criteria; stakeholders would apply one or 
more of the below criteria when submitting nominations for improvement 
activities (82 FR 53660):
     Relevance to an existing improvement activities 
subcategory (or a proposed new subcategory);
     Importance of an activity toward achieving improved 
beneficiary health outcome;
     Importance of an activity that could lead to improvement 
in practice to reduce health care disparities;
     Aligned with patient-centered medical homes;
     Focus on meaningful actions from the person and family's 
point of view;
     Support the patient's family or personal caregiver;
     Activities that may be considered for an advancing care 
information bonus;
     Representative of activities that multiple individual MIPS 
eligible clinicians or groups could perform (for example, primary care, 
specialty care);
     Feasible to implement, recognizing importance in 
minimizing burden, especially for small practices, practices in rural 
areas, or in areas designated as geographic HPSAs by HRSA;
     Evidence supports that an activity has a high probability 
of contributing to improved beneficiary health outcomes; or
     CMS is able to validate the activity.
(bb) Proposed New Criteria
    We believe it is important to place attention on public health 
emergencies, such as the opioid epidemic, when considering improvement 
activities for inclusion in the Inventory, because their inclusion 
raises awareness for clinicians about the urgency of the situation and 
to promote clinician adoption of best practices to combat those public 
health emergencies. A list of the public health emergency declarations 
is available at

[[Page 35908]]

https://www.phe.gov/Preparedness/legal/Pages/phedeclaration.aspx. 
Therefore, in this proposed rule, we are proposing to adopt an 
additional criterion entitled ``Include a public health emergency as 
determined by the Secretary'' to the criteria for nominating new 
improvement activities beginning with the CY 2019 performance period 
and future years. We invite public comment on our proposal.
(cc) Proposed Removal of One Criteria
    In the CY 2017 Quality Payment Program final rule (81 FR 77202 
through 77209), we adopted a policy to award a bonus to the Promoting 
Interoperability performance category score for MIPS eligible 
clinicians who use CEHRT to complete certain activities in the 
improvement activities performance category. We included a designation 
column in the Improvement Activities Inventory at Table H in the 
Appendix of the CY 2017 Quality Payment Program final rule (81 FR 
77817) that indicated which activities qualified for the Promoting 
Interoperability (formerly Advancing Care Information) bonus codified 
at Sec.  414.1380(b)(4)(i)(D).
    In section III.H.3.h.(5)(d)(ii) of this proposed rule, under the 
Promoting Interoperability performance category, we are proposing a new 
approach for scoring that moves away from the base, performance, and 
bonus score methodology currently established. This new approach would 
remove the availability of a bonus score for attesting to completing 
one or more specified improvement activities using CEHRT beginning with 
the CY 2019 performance period and future years. If this policy is 
finalized, then we do not believe the criterion for selecting 
improvement activities for inclusion in the program entitled 
``Activities that may be considered for an advancing care information 
bonus'' remains relevant. Therefore, we are proposing to remove the 
criterion for selecting improvement activities for inclusion in the 
program entitled ``Activities that may be considered for an advancing 
care information bonus'' beginning with the CY 2019 performance period 
and future years. We note that this proposal is being made in alignment 
with and contingent upon those in section III.H.3.h.(5)(d)(ii) of the 
proposed rule. If those proposals are not finalized, this proposal 
would also not be finalized.
    If our proposals to add one criterion and remove one criterion are 
adopted as proposed, the new list of criteria for nominating new 
improvement activities for the CY 2019 performance period and future 
years would be as follows:
     Relevance to an existing improvement activities 
subcategory (or a proposed new subcategory);
     Importance of an activity toward achieving improved 
beneficiary health outcome;
     Importance of an activity that could lead to improvement 
in practice to reduce health care disparities;
     Aligned with patient-centered medical homes;
     Focus on meaningful actions from the person and family's 
point of view;
     Support the patient's family or personal caregiver;
     Representative of activities that multiple individual MIPS 
eligible clinicians or groups could perform (for example, primary care, 
specialty care);
     Feasible to implement, recognizing importance in 
minimizing burden, especially for small practices, practices in rural 
areas, or in areas designated as geographic HPSAs by HRSA;
     Evidence supports that an activity has a high probability 
of contributing to improved beneficiary health outcomes;
     Include a public health emergency as determined by the 
Secretary; or
     CMS is able to validate the activity.
(B) Considerations in Selecting Improvement Activities
    As noted in the CY 2017 Quality Payment final rule, we intend to 
use the criteria for nominating new improvement activities in selecting 
improvement activities for inclusion in the program (82 FR 53659). 
However, we clarify here that those criteria are but one factor in 
determining which improvement activities we ultimately propose. For 
example, we also generally take into consideration other factors, such 
as whether the nominated improvement activity uses publically available 
products or techniques (that is, does not contain proprietary products 
or information limiting an activity) or whether the nominated 
improvement activity duplicates any currently adopted activity.
(C) Weighting of Improvement Activities
    Given stakeholder feedback requesting additional transparency 
regarding the weighting of improvement activities (82 FR 53657), in 
this proposed rule, we are summarizing considerations we have 
previously used to assign weights to improvement activities included in 
the Improvement Activities Inventory (see Appendix 2: Improvement 
Activities, Tables A and B). We are also making a few clarifications 
and seeking comment for future weighting considerations. These topics 
are discussed in more detail below.
(aa) Summary of Past Considerations
    In the CY 2017 Quality Payment Program final rule (81 FR 77191), we 
explained that to define the criteria and establish weighting for each 
activity, we engage multiple stakeholder groups, including the Centers 
for Disease Control, Health Resources and Services Administration, 
Office of the National Coordinator for Health Information Technology, 
SAMHSA, Agency for Healthcare Research and Quality, Food and Drug 
Administration, the Department of Veterans Affairs, and several 
clinical specialty groups, small and rural practices and non-patient 
facing clinicians. Activities were proposed to be weighted as high 
based on the extent to which they align with activities that support 
the patient-centered medical home, since that is the standard under 
section 1848(q)(5)(C)(i) of the Act for achieving the highest potential 
score for the improvement activities performance category, as well as 
with our priorities for transforming clinical practice (81 FR 77191). 
Activities that require performance of multiple actions, such as 
participation in the Transforming Clinical Practice Initiative (TCPI), 
participation in a MIPS eligible clinician's state Medicaid program, or 
an activity identified as a public health priority (such as emphasis on 
anticoagulation management or utilization of prescription drug 
monitoring programs) were also proposed to be weighted as high (81 FR 
77191). We also stated that we believe that high weighting should be 
used for activities that directly address areas with the greatest 
impact on beneficiary care, safety, health, and well-being (81 FR 
77194). In the past, we have given certain improvement activities high 
weighting due to the intensity of the activity; for example, one 
improvement activity was changed to high weighting because it often 
involves travel and work under challenging physical and clinical 
circumstances (81 FR 77194). Also, we note that successful 
participation in the CMS Study on Factors Associated with Reporting 
Quality Measures as discussed in section III.H.3.h.(4)(e) of this 
proposed rule would result in full credit for the improvement 
activities performance category of 40 points; if participants do not 
meet the study guidelines, they will need to follow the current 
improvement activities guidelines (81 FR 77197).
(bb) Clarifications
    In this proposed rule, we are clarifying: (a) Our consideration of 
giving high-weighting due to activity

[[Page 35909]]

intensity; and (b) differences between high- and medium-weighting.
(AA) High-Weighting Due to Activity Intensity
    As stated above, we have given certain improvement activities high 
weighting due to the intensity of the activity (81 FR 77194). To 
elaborate, we believe that an activity that requires significant 
investment of time and resources should be high-weighted. For example, 
we finalized the CAHPS for MIPS survey as high-weighted (81 FR 77827), 
because it requires a significant investment of time and resources. As 
part of the requirements of this activity, MIPS eligible clinicians: 
(1) Must register for the CAHPS for MIPS survey; (2) must select and 
authorize a CMS-approved survey vendor to collect and report survey 
data using the survey and specifications provided by us; and (3) are 
responsible for vendor's costs to collect and report the survey (ranges 
from approximately $4,000 to $7,000 depending on services requested).
    In contrast, we believe medium-weighted improvement activities are 
simpler to complete and require less time and resources as compared to 
high-weighted improvement activities. For example, we finalized the 
Cost Display for Laboratory and Radiographic Orders improvement 
activity as medium-weighted (82 FR 54188), because the information 
required to be used is readily available (https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/) at no 
cost through the Medicare clinical laboratory fee schedule and can be 
distributed in a variety of manners with very little investment (for 
example, it may be displayed in the clinic, provided to patients 
through hardcopies, or incorporated in the electronic health record).
(BB) High- Versus Medium-Weighting
    We recognize that we did not previously explicitly state separate 
considerations for medium-weighted activities specifically. This is 
because an improvement activity is only either high or medium-weighted. 
In this proposed rule, we are clarifying that an improvement activity 
is by default medium-weight unless it meets considerations for high-
weighting as discussed above.
(cc) Request for Comments
    We intend to more thoroughly revisit our improvement activity 
weighting policies in next year's rulemaking. We invite public comment 
on the need for additional transparency and guidance on the weighting 
of improvement activities as we work to refine the Annual Call for 
Activities process for future years. Furthermore, in light of the 
proposed policy to remove bonus points for improvement activities that 
may be applicable to the Promoting Interoperability performance 
category as discussed in sections III.H.3.h.(4)(d)(i)(A)(cc) and 
III.H.3.h.(5)(d)(ii), we recognize the need to continue incentives for 
CEHRT. Therefore, for future consideration, we are seeking comment on 
potentially applying high-weighting for any improvement activity 
employing CEHRT. We also invite public comment on any other additional 
considerations for high- or medium-weighting.
(D) Timeframe for the Annual Call for Activities
    In the CY 2018 Quality Payment Program final rule (82 FR 53660), we 
finalized that we would accept submissions for prospective improvement 
activities and modifications to existing improvement activities at any 
time during the performance period to be added to the Improvement 
Activities Under Review (IAUR) list, for the applicable performance 
period, which would be displayed on a CMS website following the close 
of the Call for Activities. In addition, we finalized that for the 
Annual Call for Activities, only nominations and modifications 
submitted by March 1st would be considered for inclusion in the IAUR 
list and Improvement Activities Inventory for the performance period 
occurring in the following calendar year (82 FR 53660). For example, 
for the CY 2018 Call for Activities, we received nominations for new 
and modified improvement activities from February 1st through March 
1st. Currently, an improvement activity nomination submitted during the 
CY 2018 Annual Call for Activities would be vetted in CY 2018, and 
after review, if accepted by CMS, would be proposed during the CY 2018 
rulemaking cycle for possible implementation in the CY 2019 performance 
period and future years.
    However, the previously established timeline, which includes 
prospective new and modified improvement activities submission period, 
review, and publication of proposed improvement activities for 
implementation in the next performance period, has become operationally 
challenging. Based on our experience over the past 2 years, we have 
found that processing and reviewing the volume of improvement 
activities nominations requires more time than originally thought. In 
addition, preparations and drafting for annual rulemaking begin around 
the time of the close date for the current Call for Activities (that 
is, March 1st), leaving incorporation into the proposed rule 
challenging. Therefore, in this proposed rule, beginning with the CY 
2019 performance period and future years, we are proposing to: (1) 
Delay the year for which nominations of prospective new and modified 
improvement activities would apply; and (2) expand the submission 
timeframe/due date for nominations.
    Beginning with the CY 2019 performance period and for future years, 
we are proposing to change the performance year for which the 
nominations of prospective new and modified improvement activities 
would apply, such that improvement activities nominations received in a 
particular year will be vetted and considered for the next year's 
rulemaking cycle for possible implementation in a future year. This 
timeframe parallels the Promoting Interoperability performance category 
Annual Call for EHR Measures timeframe found at https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/CallForMeasures.html. For example, an improvement activity nomination 
submitted during the CY 2020 Annual Call for Activities would be 
vetted, and if accepted by CMS, would be proposed during the CY 2021 
rulemaking cycle for possible implementation starting in CY 2022. We 
believe this change will give us adequate time to thoroughly vet 
improvement activity nominations prior to rulemaking.
    Second, beginning with the CY 2019 performance period, we are 
proposing to change the submission timeframe for the Call for 
Activities from February 1st through March 1st to February 1st through 
June 30th, providing approximately 4 additional months for stakeholders 
to submit nominations. We believe this change will assist stakeholders 
by providing additional time to submit improvement activities 
nominations. Consistent with previous policy, nominations for 
prospective new and modified improvement activities would be accepted 
during the Call for Activities time period only and would be included 
in the IAUR displayed on a CMS website following the close of the 
Annual Call for Activities.

[[Page 35910]]

(ii) Proposed New Improvement Activities and Modifications to and 
Removal of Existing Improvement Activities
    In the CY 2018 Quality Payment Program final rule (82 FR 53660), we 
finalized that we would add new improvement activities to the 
Improvement Activities Inventory through notice-and-comment rulemaking. 
We refer readers to Table H in the Appendix of the CY 2017 Quality 
Payment Program final rule (81 FR 77177 through 77199) and Table F and 
G in the Appendix of the CY 2018 Quality Payment Program final rule (82 
FR 54175 through 54229) for our previously finalized Improvement 
Activities Inventory. In this proposed rule, for CY 2019 performance 
period and future years, we are proposing 6 new improvement activities; 
we are also proposing to: (1) Modify 5 existing activities; and (2) 
remove 1 existing activity. We refer readers to the Improvement 
Activities Inventory in Tables A and B of Appendix 2 of this proposed 
rule for further details. We are also proposing changes to our CMS 
Study on Factors Associated with Reporting Quality Measures in section 
III.H.3.h.(4)(e) of this proposed rule.
    We invite public comments on the proposed new activities and 
modifications to and removal of existing activities listed in the 
Improvement Activities Inventory for the CY 2019 performance period and 
future years.
(e) CMS Study on Factors Associated With Reporting Quality Measures
(i) Background
    In the CY 2017 Quality Payment Program final rule (81 FR 77195), we 
created the Study on Improvement Activities and Measurement. In CMS' 
quest to create a culture of improvement using evidence based medicine 
on a consistent basis, fully understanding the strengths and 
limitations of the current processes is crucial to better understand 
the current processes. We proposed to conduct a study on clinical 
improvement activities and measurement to examine clinical quality 
workflows and data capture using a simpler approach to quality measures 
(81 FR 77196). The lessons learned in this study on practice 
improvement and measurement may influence changes to future MIPS data 
submission requirements. The goals of the study are to see whether 
there will be improved outcomes, reduced burden in reporting, and 
enhancements in clinical care by selected MIPS eligible clinicians (81 
FR 77196). This study shall inform us on the root causes of clinicians' 
performance measure data collection and submission burdens, as well as 
challenges that hinder accurate and timely quality measurement 
activities. Our goals are to use high quality, low cost measures that 
are meaningful, easy to understand, operable, reliable, and valid. As 
discussed in the CY 2017 Quality Payment Program final rule (81 FR 
77195) the CMS Study on Burden Associated with Quality Reporting goals 
are to see whether there will be improved outcomes, reduced burden in 
reporting, and enhancements in clinical care by selected MIPS eligible 
clinicians desiring:
     A more data driven approach to quality measurement.
     Measure selection unconstrained by a CEHRT program or 
system.
     Improving data quality submitted to CMS.
     Enabling CMS to get data more frequently and provide 
feedback more often.
    This study evolved into ``CMS Study on Burdens Associated with 
Reporting Quality Measures'' in the CY 2018 Quality Payment Program 
final rule (82 FR 53662).
    This study is ongoing, participants are recruited on a yearly basis 
for a minimum period of 3 years, and current participants can opt-in or 
out when the study year ends (81 FR 77195). Successful participation in 
the study would result in full credit for the improvement activities 
performance category of 40 points; if participants do not meet the 
study guidelines, they will need to follow the current improvement 
activities requirements (81 FR 77197). To meet the study requirements, 
study participants must partake in two web-based survey questionnaires, 
submit data for at least three MIPS clinician quality measures to CMS 
during the CY 2019 performance period, and be available for selection 
and participation in at least one focus group meeting (82 FR 53662).
    While we are not proposing any changes to the study purpose, aim, 
eligibility, or credit, we are proposing, for the CY 2019 performance 
period and future years, changes to the: (1) Title of the study; (2) 
sample size to allow enough statistical power for rigorous analysis 
within some categories, (3) focus group and survey requirements; and 
(4) measure requirements. These proposals are discussed in more detail 
below.
(ii) Title
    Beginning with the CY 2019 performance period, we are proposing to 
change the title of the study from ``CMS Study on Burdens Associated 
with Reporting Quality Measures'' to ``CMS Study on Factors Associated 
with Reporting Quality Measures'' to more accurately reflect the 
study's intent and purpose. To assess the root causes of clinician 
burden associated with the collection and submission of clinician 
quality measures for MIPS, as depicted in CY 2017 Quality Payment 
Program final rule (81 FR 77195), replacing ``Burden'' with ``Factors'' 
in the title will eliminate possible response or recall bias that may 
occur with data collection. Having ``burden'' in the study title may 
elicit the tendency of survey participants reporting more on their 
perception of burden and challenges, and/or suppressing other factors 
that are associated with their quality measure data collection and 
submission, that may be relevant to examining the root cause of burden.
(iii) Sample Size
(A) Current Policy
    In the CY 2017 Quality Payment Program final rule (81 FR 77196), we 
initially finalized a sample size of 42 participants (comprising of 
groups and individual MIPS eligible facilities). In the CY 2018 Quality 
Payment Program final rule (82 FR 53661), we increased that number and 
finalized a sample size of a minimum of 102 individual and group 
participants for performance periods occurring in CY 2018 for the 
following categories:
     20 urban individuals or groups of <3 eligible clinicians--
(broken down into 10 individuals & 10 groups).
     20 rural individuals or groups of <3 eligible clinicians--
(broken down into 10 individuals & 10 groups).
     10 groups of 3-8 eligible clinicians.
     10 groups of 8-20 eligible clinicians.
     10 groups of 20-100 eligible clinicians.
     10 groups of 100 or greater eligible clinicians.
     6 groups of >20 eligible clinicians reporting as 
individuals--(broken down into 3 urban & 3 rural).
     6 specialty groups--(broken down into 3 reporting 
individually & 3 reporting as a group).
     Up to 10 non-MIPS eligible clinicians reporting as a group 
or individual (any number of individuals and any group size).
(B) Proposed New Sample Size
    In this proposed rule, we are proposing to again increase the 
sample size for the CY 2019 performance period and future years from a 
minimum of 102 to a minimum of 200 MIPS eligible

[[Page 35911]]

clinicians, which will enable us to more rigorously analyze the 
statistical difference between the burden and factors associated within 
the categories listed above. This proposed increase in sample size 
would provide the minimum sample needed to get a significant result 
with adequate statistical power to determine whether there are any 
statistically significant differences in quality measurement data 
submission associated with: (1) The size of practice or facility; (2) 
clinician specialty of practice; (3) region of practice; (4) individual 
or group reporting; and (5) clinician quality measure type. This 
rigorous statistical analysis is important, because it facilitates 
tracing the root causes of measurement burdens and data submission 
errors that may be associated with various sub-groups of clinician 
practices using quantitative analytical methods. We believe that a 
larger sample size would also account for any attrition (drop out of 
study participants before the study ends). Therefore, we are proposing 
that the new sample size distribution would be:
     40 urban individuals or groups of <3 eligible clinicians--
(broken down into 20 individuals & 20 groups).
     40 rural individuals or groups of <3 eligible clinicians--
(broken down into 20 individuals & 20 groups).
     20 groups of 3-8 eligible clinicians.
     20 groups of 8-20 eligible clinicians.
     20 groups of 20-100 eligible clinicians.
     20 groups of 100 or greater eligible clinicians.
     Up to 6 groups of >20 eligible clinicians reporting as 
individuals--(broken down into 3 urban & 3 rural).
     Up to 6 specialty groups--(broken down into 3 reporting 
individually & 3 reporting as a group).
     Up to 10 non-MIPS eligible clinicians reporting as a group 
or individual (any number of individuals and any group size).
(iv) Focus Group
(A) Current Policies
    We previously finalized in the CY 2017 Quality Payment Program 
final rule (81 FR 77195) that for the transition year of MIPS, study 
participants were required to attend a monthly focus group to share 
lessons learned in submitting quality data along with providing survey 
feedback to monitor effectiveness. The focus group includes providing 
visual displays of data, workflows, and best practices to share amongst 
the participants to obtain feedback and make further improvements (81 
FR 77196). The focus groups are used to learn from the practices about 
how to be more agile as we test new ways of measure recording and 
workflow (81 FR 77196). In the CY 2018 Quality Payment Program final 
rule (82 FR 53662), for Year 2 and future years, we reduced that 
requirement and finalized that study participants would be required to 
complete at least two web-based survey questionnaire and attend up to 4 
focus group sessions throughout the year, but certain study 
participants would be able to attend less frequently. Each study 
participant is required to complete a survey prior to submitting MIPS 
data and another survey after submitting MIPS data (82 FR 53662). The 
purpose of reducing focus group attendance and survey participation was 
to ease requirements for MIPS eligible clinicians or group of 
clinicians who may have nothing new to contribute, without compromising 
the minimum sample needed for focus groups. For example, if a MIPS 
eligible clinician submitted all 6 measures after collecting 90 days of 
data and attended the first available focus group and/or survey, the 
clinician may have nothing new or relevant to discuss with the research 
team on subsequent focus groups and/or surveys.
(B) Proposed New Requirements for Focus Group and Survey Participation
    Although we are proposing in the section above to increase the 
sample size of the study to a minimum of 200 MIPS eligible clinicians, 
we do not believe we need focus groups for the entirety of that 
population. We believe that requiring focus groups for all proposed 
minimum of 200 MIPS eligible clinicians would only result in bringing 
the data to a saturation point, a situation whereby the same themes and 
information are recurring, and no new insights are given by additional 
sources of data from focus groups.
    Instead, we believe that selecting a subset of clinicians, 
purposively, to participate in focus groups would be a more appropriate 
approach because that would allow us to understand the experience of 
select clinicians without imposing undue burden on all. This study is 
voluntary as clinicians nominate themselves to participate and we 
select a cohort from among these volunteers. Therefore, we are 
proposing to make the focus group participation a requirement only for 
a selected subset of the study participants, using purposive sampling 
and random sampling methods, beginning with the CY 2019 performance 
period and future years. Those who are selected would be required to 
participate, in at least one focus group meeting and complete survey 
requirements, in addition to all the other study requirements. As 
previously established, each study participant is required to complete 
a survey prior to submitting MIPS data and another survey after 
submitting MIPS data. This requirement would continue to apply for each 
selected subset participating in a focus group.
(v) Measure Requirements
(A) Current Requirements
    In the CY 2017 Quality Payment Program final rule (81 FR 77196), we 
finalized that for CY 2017, the participating MIPS eligible clinicians 
or groups would submit their data and workflows for a minimum of three 
MIPS clinician quality measures that are relevant and prioritized by 
their practice. One of the measures must be an outcome measure, and one 
must be a patient experience measure (81 FR 77196). We also finalized 
that for future years, participating MIPS eligible clinicians or groups 
would select three of the measures for which they have baseline data 
from the 2017 performance period to compare against later performance 
years. We note that participating MIPS eligible clinicians could elect 
to report on more measures originally as this would provide more 
options from which to select in subsequent years for purposes of 
measuring improvement. In the CY 2018 Quality Payment Program final 
rule, we finalized for the Quality Payment Program Year 2 and future 
years, that study participants could submit all their quality measures 
data at once, as it is done in the MIPS program, (qpp.cms.gov) (82 FR 
53662).
(B) Proposed Measure Requirements
    In this proposed rule, we are proposing to continue the previously 
required minimum number of measures. That is, for the CY 2019 
performance period and future years: Participants must submit data and 
workflows for a minimum of three MIPS quality measures for which they 
have baseline data. However, instead of requiring one outcome measure 
and one patient experience measure as previously finalized, we are 
proposing that, for the CY 2019 performance period and future years, at 
least one of the minimum of three measures must be a high priority 
measure as defined at Sec.  414.1305. As defined there and discussed in 
section III.H.3.h.(2) of this proposed rule, a high priority measure 
means an outcome, appropriate use, patient safety, efficiency, patient 
experience, care coordination, or opioid-related quality

[[Page 35912]]

measure. Outcome measures includes intermediate-outcome and patient-
reported outcome measures. We believe that focusing on high priority 
measures, rather than patient experience measures, is important at this 
time, because it better aligns with the MIPS quality measures data 
submission criteria. We invite public comment on our proposal.
    We note that although the aforementioned activities (that is, the 
CMS Study on Factors Associated with Reporting Quality Measures) 
constitute an information collection request as defined in the 
implementing regulations of the Paperwork Reduction Act of 1995 (5 CFR 
part 1320), the associated burden is exempt from application of the 
Paperwork Reduction Act. Specifically, section 1848(s) (7) of the Act, 
as added by section 102 of MACRA (Pub. L. 114-10) states that Chapter 
35 of title 44, United States Code, shall not apply to the collection 
of information for the development of quality measures.
(5) Promoting Interoperability (PI) (Previously Known as the Advancing 
Care Information Performance Category)
(a) Background
    Section 1848(q)(2)(A) of the Act includes the meaningful use of 
CEHRT as a performance category under the MIPS. In prior rulemaking, we 
referred to this performance category as the advancing care information 
performance category, and it is reported by MIPS eligible clinicians as 
part of the overall MIPS program. As required by sections 1848(q)(2) 
and (5) of the Act, the four performance categories of the MIPS shall 
be used in determining the MIPS final score for each MIPS eligible 
clinician. In general, MIPS eligible clinicians will be evaluated under 
all four of the MIPS performance categories, including the advancing 
care information performance category.
(b) Renaming the Advancing Care Information Performance Category
    In this proposed rule, we are proposing several scoring and 
measurement policies that would bring the performance category to a new 
phase of EHR measurement with an increased focus on interoperability 
and improving patient access to health information. To better reflect 
this focus, we renamed the advancing care information performance 
category to the Promoting Interoperability (PI) performance category. 
We believe this change will help highlight the enhanced goals of this 
performance category. We are proposing revisions to the regulation text 
under 42 CFR part 414, subpart O, to reflect the new name.
(c) Certification Requirements Beginning in 2019
    Under the definition of CEHRT under Sec.  414.1305, for the 
performance periods in 2017 and 2018, MIPS eligible clinicians had 
flexibility to use EHR technology certified to either the 2014 or 2015 
Edition certification criteria, or a combination of the two Editions, 
to meet the objectives and measures specified for the Promoting 
Interoperability performance category (82 FR 53671 through 53672). 
However, beginning with the performance period in 2019, MIPS eligible 
clinicians must use EHR technology certified to the 2015 Edition 
certification criteria as specified at Sec.  414.1305. As discussed in 
this section, we continue to believe it is appropriate to require the 
use of 2015 Edition CEHRT beginning in CY 2019. In reviewing the state 
of health information technology, it is clear the 2014 Edition 
certification criterion are out of date and insufficient for clinician 
needs in the evolving health information technology (IT) industry. It 
would be beneficial to health IT developers and health care providers 
to move to more up-to-date standards and functions that better support 
interoperable exchange of health information and improve clinical 
workflows.
    The 2014 Edition certification criteria, which were first issued in 
regulations in 2012, now includes standards that are significantly out 
of date, which can impose limits on interoperability and the access, 
exchange, and use of health information. Moving from certifying to the 
2014 Edition to certifying to the 2015 Edition would also eliminate the 
inconsistencies that are inherent with maintaining and implementing two 
separate certification programs. In the last calendar year, the number 
of new and unique 2014 Edition products have been declining, showing 
that the market acknowledges the shift towards newer and more effective 
technologies. The vast majority of 2014 Edition certifications are for 
inherited certified status. The resulting legacy systems, while 
certified to the 2014 Edition, are not the most up-to-date and detract 
from health information technology's goal of increasing 
interoperability and increasing the access, exchange, and use of health 
data.
    Prolonging backwards compatibility of newer products to legacy 
systems causes market fragmentation. Health IT stakeholders noted the 
impact of system fragmentation on the cost to develop and maintain 
health IT connectivity to support data exchange, develop products to 
support specialty clinical care, and integrate software supporting 
administrative and clinical processes. As previously stated, a large 
proportion of the sector is ready to use only the 2015 Edition of 
CEHRT; allowing use of both certification editions contributes to 
market fragmentation, which heightens implementation costs for health 
IT developers, clinicians, and other health care providers. Developers 
and consumers that maintain two different certification editions spend 
large amounts of money on the recertification of older products, which 
diverts resources from the development, maintenance, and implementation 
of more advanced technologies, including 2015 Edition CEHRT.
    In addition to the monetary savings resulting from a move to the 
2015 Edition, there will also be reduced burden across many settings. 
MIPS eligible clinicians will see a reduction in burden through the 
relief from certifying to a legacy system and can use 2015 Edition 
CEHRT to better streamline workflows and utilize more comprehensive 
functions to meet patient safety goals and improve care coordination 
across the continuum. Maintaining only one edition of certification 
requirements would also reduce the burden for health IT developers, as 
well as Office of the National Coordinator for Health Information 
Technology (ONC)-Authorized Testing Laboratories and ONC-Authorized 
Certification Bodies because they would no longer have to support two, 
increasingly distant sets of requirements.
    One of the major improvements of the 2015 Edition is the 
Application Programming Interface (API) functionality. The API 
functionality supports health care providers and patient electronic 
access to health information. These functions allow for patient data to 
move between systems and assist patients with making key decisions 
about their health care. These functions also contribute to quality 
improvement and greater interoperability between systems. The API has 
the ability to complement a specific health care provider branded 
patient portal or could also potentially make one unnecessary if 
patients are able to use software applications designed to interact 
with an API that could support their ability to view, download, and 
transmit their health information to a third party (80 FR 62842). 
Furthermore, the API allows for third-party application usage with more 
flexibility and smoother workflow from various systems than what is 
often found in many current patient portals.

[[Page 35913]]

    The 2015 Edition also includes certification criterion specifying a 
core set of data that health care providers have noted are critical to 
interoperable exchange and can be exchanged across a wide variety of 
other settings and use cases, known as the Common Clinical Data Set 
(CCDS) (80 FR 62603). The US Core Data for Interoperability (USCDI) 
builds off the CCDS definition adopted for the 2015 Edition of 
certified health IT for instance as the data which must be included in 
a summary care record. The USCDI aims to support the goals set forth in 
the 21st Century Cures Act by specifying a common set of data classes 
that are required for interoperable exchange and identifying a 
predictable, transparent, and collaborative process for achieving those 
goals. The USCDI is referenced by the Draft Trusted Exchange Framework 
(https://www.healthit.gov/sites/default/files/draft-trusted-exchange-framework.pdf), which is intended to enable Healthcare Information 
Networks (HINs) and Qualified HINs to securely exchange electronic 
health information in support of a range permitted purposes, including 
treatment, payment, operations, individual access, public health, and 
benefits determination.
    The 2015 Edition also includes a requirement that products must be 
able to export data from one patient, a set of patients, or a subset of 
patients, which is responsive to health care provider feedback that 
their data is unable to carry over from a previous EHR. The 2014 
Edition did not include a requirement that the vendor allow the MIPS 
eligible clinician to export the data themselves. In the 2015 Edition, 
the health care provider has the autonomy to export data themselves 
without intervention by their vendor, resulting in increased 
interoperability and data exchange in the 2015 Edition.
    In efforts to track certification readiness for the 2015 Edition, 
ONC considers the number of health care providers likely to be served 
by the developers seeking certification under the ONC Health IT 
Certification Program in real time as the testing and certification 
process progresses. The ONC considers trends within the industry when 
projecting for 2015 Edition readiness. In working with ONC, we are able 
to identify the percentage of MIPS eligible clinicians that have a 2015 
Edition of CEHRT available to them based on vendor readiness and 
information. As of the beginning of the first quarter of CY 2018, ONC 
confirmed that at least 66 percent of MIPS eligible clinicians have 
2015 Edition CEHRT available based on previous Medicare and Medicaid 
EHR Incentive Programs attestation data. Based on these data, and as 
compared to the transition from 2011 Edition to 2014 Edition, it 
appears that the transition from the 2014 Edition to the 2015 Edition 
is on schedule for the performance period in CY 2019.
    This information is current as of the beginning of CY 2018, and 
based on historical data, we expect readiness to continue to improve as 
developers and health care providers prepare for program participation 
using the 2015 Edition in CY 2019.
    We continue to recognize there is a burden associated with 
development and deployment of new technology, but we believe requiring 
use of the most recent version of CEHRT is important in ensuring health 
care providers will use technology that has improved interoperability 
features and up-to-date standards to collect and exchange relevant 
patient health information. The 2015 Edition includes key updates to 
functions and standards that support improved interoperability and 
clinical effectiveness through the use of health IT.
(d) Scoring Methodology
(i) Scoring Methodology for 2017 and 2018 Performance Periods
    Section 1848(q)(5)(E)(i)(IV) of the Act states that 25 percent of 
the MIPS final score shall be based on performance for the Promoting 
Interoperability performance category. Accordingly, under Sec.  
414.1375(a), the Promoting Interoperability performance category 
comprises 25 percent of a MIPS eligible clinician's final score for the 
2019 MIPS payment year and each MIPS payment year thereafter, unless we 
assign a different scoring weight. We are proposing to revise Sec.  
414.1375(a) to specify the various sections of the statute (sections 
1848(o)(2)(D), 1848(q)(5)(E)(ii), and 1848(q)(5)(F) of the Act) under 
which a different scoring weight may be assigned for the Promoting 
Interoperability performance category. We established the reporting 
criteria to earn a performance category score for the Promoting 
Interoperability performance category under Sec.  414.1375(b). We are 
proposing to revise Sec.  414.1375(b)(2)(i) to replace the reference to 
``each required measure'' with ``each base score measure'' to improve 
the precision of the text. Under Sec.  414.1380(b)(4), the Promoting 
Interoperability performance category score is comprised of a score for 
participation and reporting, known as the ``base score,'' and a score 
for performance at varying levels above the base score requirements, 
known as the ``performance score,'' as well as any applicable bonus 
scores. We are proposing several editorial changes to Sec.  
414.1380(b)(4) in an effort to more clearly and concisely capture the 
previously established policies. For further explanation of our scoring 
policies for performance periods in 2017 and 2018 for the Promoting 
Interoperability performance category, we refer readers to 81 FR 77216 
through 77227 and 82 FR 53663 through 53664.
    A general summary overview of the scoring methodology for the 
performance period in 2018 is provided in the Table 35.

Table 35--2018 Performance Period Promoting Interoperability Performance Category Scoring Methodology Promoting Interoperability Objectives and Measures
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                       2018 Promoting
 2018 Promoting interoperability      interoperability     Required/not required for   Performance score (up to 90%)         Reporting requirement
            objective                     measure              base score (50%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Protect Patient Health             Security Risk          Required..................  0.............................  Yes/No Statement.
 Information.                       Analysis.
Electronic Prescribing...........  e-Prescribing **.....  Required..................  0.............................  Numerator/Denominator.
Patient Electronic Access........  Provide Patient        Required..................  Up to 10......................  Numerator/Denominator.
                                    Access.
                                   Patient-Specific       Not Required..............  Up to 10......................  Numerator/Denominator.
                                    Education.
Coordination of Care Through       View, Download, or     Not Required..............  Up to 10......................  Numerator/Denominator.
 Patient Engagement.                Transmit (VDT).       Not Required..............  Up to 10......................  Numerator/Denominator.
                                   Secure Messaging.....
                                   Patient-Generated      Not Required..............  Up to 10......................  Numerator/Denominator.
                                    Health Data.
Health Information Exchange......  Send a Summary of      Required..................  Up to 10......................  Numerator/Denominator.
                                    Care **.

[[Page 35914]]

 
                                   Request/Accept         Required..................  Up to 10......................  Numerator/Denominator.
                                    Summary of Care **.
                                   Clinical Information   Not Required..............  Up to 10......................  Numerator/Denominator.
                                    Reconciliation.
Public Health and Clinical Data    Immunization Registry  Not Required..............  0 or 10 *.....................  Yes/No Statement.
 Registry Reporting.                Reporting.            Not Required..............  0 or 10 *.....................  Yes/No Statement
                                   Syndromic
                                    Surveillance
                                    Reporting.
                                   Electronic Case        Not Required..............  0 or 10 *.....................  Yes/No Statement.
                                    Reporting.
                                   Public Health          Not Required..............  0 or 10 *.....................  Yes/No Statement.
                                    Registry Reporting.
                                   Clinical Data          Not Required..............  0 or 10 *.....................  Yes/No Statement.
                                    Registry Reporting.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Bonus (up to 25%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Report to one or more additional public health agencies 5% bonus                      Yes/No Statement..............
 or clinical data registries beyond the one identified
 for the performance score.
                                  ----------------------------------------------------------------------------------------------------------------------
Report improvement activities using CEHRT.............. 10% bonus                     Yes/No Statement..............
                                  ----------------------------------------------------------------------------------------------------------------------
Report using only 2015 Edition CEHRT................... 10% bonus                     Based on measures submitted...
--------------------------------------------------------------------------------------------------------------------------------------------------------
* A MIPS eligible clinician may earn 10 percent for each public health agency or clinical data registry to which the clinician reports, up to a maximum
  of 10 percent under the performance score.
** Exclusions are available for these measures.

    We heard from many stakeholders that the current scoring 
methodology is complicated and difficult to understand. In fact, we 
have received hundreds of questions requesting clarification of various 
aspects of the scoring methodology. For example, many clinicians asked 
how many performance score measures they should submit. By providing 
flexibility and offering clinicians multiple measures to choose from 
within the performance score, it appears some clinicians may have been 
confused by the options. Other MIPS eligible clinicians have indicated 
that they dislike the base score because it is a required set of 
measures and provides no flexibility because the scoring is all or 
nothing. If a MIPS eligible clinician cannot fulfill the base score, 
they cannot earn a performance and/or bonus score. We have also 
received feedback from clinicians and specialty societies that the 
current requirements detract from their ability to provide care to 
their patients. In addition, stakeholders have indicated that the 
requirements of the Promoting Interoperability performance category for 
clinicians do not align with the requirements of the Medicare Promoting 
Interoperability Program for eligible hospitals and critical access 
hospitals (CAHs) and that this creates a burden for the medical staff 
who are tasked with overseeing the participation of both clinicians and 
hospitals in these programs.
    Based on the concerns expressed by stakeholders, we are proposing a 
new scoring methodology and moving away from the base, performance and 
bonus score methodology that we currently use. We believe this change 
would provide a simpler, more flexible, less burdensome structure, 
allowing MIPS eligible clinicians to put their focus back on patients. 
The introduction of this new scoring methodology would continue to 
encourage MIPS eligible clinicians to push themselves on measures that 
are most applicable to how they deliver care to patients, instead of 
focusing on measures that may not be as applicable to them. Our goal is 
to provide increased flexibility to MIPS eligible clinicians and enable 
them to focus more on patient care and health data exchange through 
interoperability. Additionally, we want to align the requirements of 
the Promoting Interoperability performance category with the 
requirements of the Medicare Promoting Interoperability Program for 
eligible hospitals and CAHs as we have proposed in the FY 2019 IPPS/
LTCH PPS proposed rule (83 FR 20518 through 20537). As the distinction 
between ambulatory and inpatient CEHRT has diminished and more 
clinicians are sharing hospitals' CEHRT, we believe that aligning the 
requirements between programs would lessen the burden on health care 
providers and facilitate their participation in both programs.
(ii) Proposed Scoring Methodology Beginning With the MIPS Performance 
Period in 2019
    We are proposing a new scoring methodology, beginning with the 
performance period in 2019, to include a combination of new measures, 
as well as the existing Promoting Interoperability performance category 
measures, broken into a smaller set of four objectives and scored based 
on performance. We believe this is an overhaul of the existing program 
requirements as it eliminates the concept of base and performance 
scores. The smaller set of objectives would include e-Prescribing, 
Health Information Exchange, Provider to Patient Exchange, and Public 
Health and Clinical Data Exchange. We are proposing these objectives to 
promote specific HHS priorities and satisfy the requirements of section 
1848(o)(2) of the Act. We include the e-Prescribing and Health 
Information Exchange objectives in part to capture what we believe are 
core goals for the 2015 Edition of CEHRT and also to satisfy the 
statutory requirements. These core goals promote interoperability 
between health care providers and health IT systems to support safer, 
more coordinated care. The Provider to Patient Exchange objective 
promotes patient awareness and involvement in their health care through 
the use of APIs, and ensures patients have access to their medical 
data. Finally, the Public Health and Clinical Data Exchange objective 
supports the ongoing systematic

[[Page 35915]]

collection, analysis, and interpretation of data that may be used in 
the prevention and controlling of disease through the estimation of 
health status and behavior. The integration of health IT systems into 
the national network of health data tracking and promotion improves the 
efficiency, timeliness, and effectiveness of public health 
surveillance. We believe it is important to keep these core goals, 
primarily because these objectives promote interoperability between 
health care providers and health IT systems to support safer, more 
coordinated care while ensuring patients have access to their medical 
data.
    Under the proposed scoring methodology, MIPS eligible clinicians 
would be required to report certain measures from each of the four 
objectives, with performance-based scoring occurring at the individual 
measure-level. Each measure would be scored based on the MIPS eligible 
clinician's performance for that measure, based on the submission of a 
numerator and denominator, except for the measures associated with the 
Public Health and Clinical Data Exchange objective, which require ``yes 
or no'' submissions. Each measure would contribute to the MIPS eligible 
clinician's total Promoting Interoperability performance category 
score. The scores for each of the individual measures would be added 
together to calculate the Promoting Interoperability performance 
category score of up to 100 possible points for each MIPS eligible 
clinician. In general, the Promoting Interoperability performance 
category score makes up 25 percent of the MIPS final score. If a MIPS 
eligible clinician fails to report on a required measure or claim an 
exclusion for a required measure if applicable, the clinician would 
receive a total score of zero for the Promoting Interoperability 
performance category.
    We also considered an alternative approach in which scoring would 
occur at the objective level, instead of the individual measure level, 
and MIPS eligible clinicians would be required to report on only one 
measure from each objective to earn a score for that objective. Under 
this scoring methodology, instead of six required measures, the MIPS 
eligible clinician total Promoting Interoperability performance 
category score would be based on only four measures, one measure from 
each objective. Each objective would be weighted similarly to how the 
objectives are weighted in our proposed methodology, and bonus points 
would be awarded for reporting any additional measures beyond the 
required four. We are seeking public comment on this alternative 
approach, and whether additional flexibilities should be considered, 
such as allowing MIPS eligible clinicians to select which measures to 
report on within an objective and how those objectives should be 
weighted, as well as whether additional scoring approaches or 
methodologies should be considered.
    In our proposed scoring methodology, the e-Prescribing objective 
would contain three measures each weighted differently to reflect their 
potential availability and applicability to the clinician community. In 
addition to the existing e-Prescribing measure, we are proposing to add 
two new measures to the e-Prescribing objective: Query of Prescription 
Drug Monitoring Program (PDMP); and Verify Opioid Treatment Agreement. 
For more information about these two proposed measures, we refer 
readers to section. III.H.3.h.(5)(f) of this proposed rule. The e-
Prescribing measure would be required for reporting and weighted at 10 
points because we believe it would be applicable to most MIPS eligible 
clinicians. In the event that a MIPS eligible clinician meets the 
criteria and claims the exclusion for the e-Prescribing measure in 
2019, the 10 points available for that measure would be redistributed 
equally among the two measures under the Health Information Exchange 
objective:
     Support Electronic Referral Loops By Sending Health 
Information Measure (25 points)
     Support Electronic Referral Loops By Receiving and 
Incorporating Health Information (25 points)
    We are seeking public comment on whether this redistribution is 
appropriate for 2019, or whether the points should be distributed 
differently.
    The Query of PDMP and Verify Opioid Treatment Agreement measures 
would be optional for the MIPS performance period in 2019. These new 
measures may not be available to all MIPS eligible clinicians for the 
MIPS performance period in 2019 as they may not have been fully 
developed by their health IT vendor, or not fully implemented in time 
for data capture and reporting. Therefore, we are not proposing to 
require these two new measures in 2019, although MIPS eligible 
clinicians may choose to report them and earn up to 5 bonus points for 
each measure. We are proposing to require these measures beginning with 
the MIPS performance period in 2020, and we are seeking public comment 
on this proposal. Due to varying State requirements, not all MIPS 
eligible clinicians would be able to e-prescribe controlled substances, 
and thus, these measures would not be available to them. For these 
reasons, we are proposing an exclusion for these two measures beginning 
with the MIPS performance period in 2020. The exclusion would provide 
that any MIPS eligible clinician who is unable to report the measure in 
accordance with applicable law would be excluded from reporting the 
measure, and the 5 points assigned to that measure would be 
redistributed to the e-Prescribing measure.
    As the two new opioid measures become more broadly available in 
CEHRT, we are proposing each of the three measures within the e-
Prescribing objective would be worth 5 points beginning with the MIPS 
performance period in 2020. Requiring these two measures would add 10 
points to the maximum total score for the Promoting Interoperability 
performance category as these measures would no longer be eligible for 
optional bonus points. To maintain a maximum total score of 100 points, 
beginning with the MIPS performance period in 2020, we are proposing to 
reweight the e-Prescribing measure from 10 points down to 5 points, and 
reweight the Provide Patients Electronic Access to Their Health 
Information measure from 40 points down to 35 points as illustrated in 
Table 36. We are proposing that if the MIPS eligible clinician 
qualifies for the e-Prescribing exclusion and is excluded from 
reporting all three of the measures associated with the e-Prescribing 
objective as described in section III.H.3.h.(5)(f) of this proposed 
rule, the 15 points for the e-Prescribing objective would be 
redistributed evenly among the two measures associated with the Health 
Information Exchange objective and the Provide Patients Electronic 
Access to their Health Information measure by adding 5 points to each 
measure.
    For the Health Information Exchange objective, we are proposing to 
change the name of the existing Send a Summary of Care measure to 
Support Electronic Referral Loops by Sending Health Information, and 
proposing a new measure which combines the functionality of the 
existing Request/Accept Summary of Care and Clinical Information 
Reconciliation measures into a new measure, Support Electronic Referral 
Loops by Receiving and Incorporating Health Information. For more 
information about the proposed measure and measure changes, we refer 
readers to section III.H.3.h.(5)(f) of this proposed rule. MIPS 
eligible clinicians would be required to report both of these measures, 
each worth 20 points toward their total Promoting

[[Page 35916]]

Interoperability performance category score. These measures are 
weighted heavily to emphasize the importance of sharing health 
information through interoperable exchange in an effort to promote care 
coordination and better patient outcomes. Similar to the two new 
measures in the e-Prescribing objective, the new Support Electronic 
Referral Loops by Receiving and Incorporating Health Information 
measure may not be available to all MIPS eligible clinicians as it may 
not have been fully developed by their health IT vendor, or not fully 
implemented in time for a MIPS performance period in 2019. For these 
reasons, we are proposing an exclusion for the Support Electronic 
Referral Loops by Receiving and Incorporating Health Information 
measure: Any MIPS eligible clinician who is unable to implement the 
measure for a MIPS performance period in 2019 would be excluded from 
having to report this measure.
    In the event that a MIPS eligible clinician claims an exclusion for 
the Support Electronic Referral Loops by Receiving and Incorporating 
Health Information measure, the 20 points would be redistributed to the 
Support Electronic Referral Loops by Sending Health Information 
measure, and that measure would then be worth 40 points. We are seeking 
public comment on whether this redistribution is appropriate, or 
whether the points should be redistributed to other measures instead.
    We are proposing to weight the one measure in the Provider to 
Patient Exchange objective, Provide Patients Electronic Access to Their 
Health Information, at 40 points toward the total Promoting 
Interoperability performance category score in 2019 and 35 points 
beginning in 2020. We are proposing that this measure would be weighted 
at 35 points beginning in 2020 to account for the two new opioid 
measures, which would be worth 5 points each beginning in 2020 as 
proposed above. We believe this objective and its associated measure 
get to the core of improved access and exchange of patient data in 
Promoting Interoperability and are the crux of the Promoting 
Interoperability performance category. This exchange of data between 
health care provider and patient is imperative in order to continue to 
improve interoperability, data exchange and improved health outcomes. 
We believe that it is important for patients to have control over their 
own health information, and through this highly weighted objective we 
are aiming to show our dedication to this effort.
    The measures under the Public Health and Clinical Data Exchange 
objective are reported using ``yes or no'' responses and thus we are 
proposing to score those measures on a pass/fail basis in which the 
MIPS eligible clinician would receive the full 10 points for reporting 
two ``yes'' responses, or for submitting a ``yes'' for one measure and 
claiming an exclusion for another. If there are no ``yes'' responses 
and two exclusions are claimed, the 10 points would be redistributed to 
the Provide Patients Electronic Access to Their Health Information 
measure. A MIPS eligible clinician would receive zero points for 
reporting ``no'' responses for the measures in this objective if they 
do not submit a ``yes'' or claim an exclusion for at least two measures 
under this objective. We are proposing that for this objective, the 
MIPS eligible clinician would be required to report on two measures of 
their choice from the following list of measures: Immunization Registry 
Reporting, Electronic Case Reporting, Public Health Registry Reporting, 
Clinical Data Registry Reporting, and Syndromic Surveillance Reporting. 
To account for the possibility that not all of the measures under the 
Public Health and Clinical Data Exchange objective may be applicable to 
all MIPS eligible clinicians, we are proposing to establish exclusions 
for these measures as described in section III.H.3.h.(5)(f) of this 
proposed rule. If a MIPS eligible clinician claims two exclusions, the 
10 points for this objective would be redistributed to the Provide 
Patients Electronic Access to their Health Information measure under 
the Provider to Patient Exchange objective, making that measure worth 
50 points in 2019 and 45 points beginning in 2020. Reporting more than 
two measures for this objective would not earn the MIPS eligible 
clinician any additional points. We refer readers to section 
III.H.3.h.(5)(f) of this proposed rule in regard to the proposals for 
the Public Health and Clinical Data Exchange objective and its 
associated measures.
    We propose that the Protect Patient Health Information objective 
and its associated measure, Security Risk Analysis, would remain part 
of the requirements for the Promoting Interoperability performance 
category, but would no longer be scored as a measure and would not 
contribute to the MIPS eligible clinician's Promoting Interoperability 
performance category score. To earn any score in the Promoting 
Interoperability performance category, we are proposing a MIPS eligible 
clinician would have to report that they completed the actions included 
in the Security Risk Analysis measure at some point during the calendar 
year in which the performance period occurs. We believe the Security 
Risk Analysis measure involves critical tasks and note that the HIPAA 
Security Rule requires covered entities to conduct a risk assessment of 
their healthcare organization. This risk assessment will help MIPS 
eligible clinicians comply with HIPAA's administrative, physical, and 
technical safeguards. Therefore, we believe that every MIPS eligible 
clinician should already be meeting the requirements for this objective 
and measure as it is a requirement of HIPAA. We still believe this 
objective and its associated measure are imperative in ensuring the 
safe delivery of patient health data. As a result, we would maintain 
the Security Risk Analysis measure as part of the Promoting 
Interoperability performance category, but we would not score the 
measure.
    Similar to how MIPS eligible clinicians currently submit data, the 
MIPS eligible clinician would submit their numerator and denominator 
data for each measure, and a ``yes or no'' response for each of the two 
reported measures under the Public Health and Clinical Data Exchange 
objective. The numerator and denominator for each measure would then 
translate to a performance rate for that measure and would be applied 
to the total possible points for that measure. For example, the e-
Prescribing measure is worth 10 points. A numerator of 200 and 
denominator of 250 would yield a performance rate of (200/250) = 80 
percent. This 80 percent would be applied to the 10 total points 
available for the e-Prescribing measure to determine the measure score. 
A performance rate of 80 percent for the e-Prescribing measure would 
equate to a measure score of 8 points (performance rate * total 
possible measure points = points awarded toward the total Promoting 
Interoperability performance category score; 80 percent * 10 = 8 
points). To calculate the Promoting Interoperability performance 
category score, the measure scores would be added together, and the 
total sum would be divided by the total possible points (100). The 
total sum cannot exceed the total possible points. This calculation 
results in a fraction from zero to 1, which can be formatted as a 
percent. For example, using the numerical values in Table 38, a total 
score of 83 points would be converted to a performance category score 
of 83 percent (total score/total possible score for the Promoting

[[Page 35917]]

Interoperability performance category = 83 points/100 points). The 
Promoting Interoperability performance category score would be 
multiplied by the performance category weight (which is ultimately 
multiplied by 100) to get 20.75 points toward the final score ((83 
percent * 25 percent * 100) = 20.75 points toward the final score.) 
These calculations and application to the total Promoting 
Interoperability performance category score, as well as an example of 
how they would apply, are set out in Tables 36, 37, and 38.
    When calculating the performance rates, measure and objective 
scores, and Promoting Interoperability performance category score, we 
would generally round to the nearest whole number. For example if a 
MIPS eligible clinician received a score of 8.53 the nearest whole 
number would be 9. Similarly, if the MIPS eligible clinician received a 
score of 8.33 the nearest whole number would be 8. In the event that 
the MIPS eligible clinician receives a performance rate or measure 
score of less than 0.5, as long as the MIPS eligible clinician reported 
on at least one patient for a given measure, a score of 1 would be 
awarded for that measure. We believe this is the best method for the 
issues that might arise with the decimal points and is the easiest for 
computations.
    In order to meet statutory requirements and HHS priorities, the 
MIPS eligible clinician would need to report on all of the required 
measures across all objectives in order to earn any score at all for 
the Promoting Interoperability performance category. Failure to report 
any required measure, or reporting a ``no'' response on a ``yes or no'' 
response measure, unless an exclusion applies would result in a score 
of zero. We are seeking public comment on the proposed requirement to 
report on all required measures, or whether reporting on a smaller 
subset of optional measures would be appropriate.
    Tables 36, 37, and 38 illustrate our proposal for the new scoring 
methodology and an example of application of the proposed scoring 
methodology.

                 Table 36--Proposed Scoring Methodology for the MIPS Performance Period in 2019
----------------------------------------------------------------------------------------------------------------
              Objectives                                Measures                          Maximum points
----------------------------------------------------------------------------------------------------------------
e-Prescribing.........................  e-Prescribing...........................  10 points.
                                        Bonus: Query of Prescription Drug         5 points bonus.
                                         Monitoring Program (PDMP).
                                        Bonus: Verify Opioid Treatment Agreement  5 points bonus.
Health Information Exchange...........  Support Electronic Referral Loops by      20 points.
                                         Sending Health Information.
                                        Support Electronic Referral Loops by      20 points.
                                         Receiving and Incorporating Health
                                         Information.
Provider to Patient Exchange..........  Provide Patients Electronic Access to     40 points.
                                         Their Health Information.
Public Health and Clinical Data         Choose two of the following:............  10 points.
 Exchange.                              Immunization Registry Reporting.........
                                        Electronic Case Reporting...............
                                        Public Health Registry Reporting........
                                        Clinical Data Registry Reporting........
                                        Syndromic Surveillance Reporting........
----------------------------------------------------------------------------------------------------------------


              Table 37--Proposed Scoring Methodology Beginning With MIPS Performance Period in 2020
----------------------------------------------------------------------------------------------------------------
              Objectives                                Measures                          Maximum points
----------------------------------------------------------------------------------------------------------------
e-Prescribing.........................  e-Prescribing...........................  5 points.
                                        Query of Prescription Drug Monitoring     5 points.
                                         Program (PDMP).
                                        Verify Opioid Treatment Agreement.......  5 points.
Health Information Exchange...........  Support Electronic Referral Loops by      20 points.
                                         Sending Health Information.
                                        Support Electronic Referral Loops by      20 points.
                                         Receiving and Incorporating Health
                                         Information.
Provider to Patient Exchange..........  Provide Patients Electronic Access to     35 points.
                                         Their Health Information.
Public Health and Clinical Data         Choose two of the following:............  10 points.
 Exchange.                              Immunization Registry Reporting.........
                                        Electronic Case Reporting...............
                                        Public Health Registry Reporting........
                                        Clinical Data Registry Reporting........
                                        Syndromic Surveillance Reporting........
----------------------------------------------------------------------------------------------------------------

    We are seeking public comment on whether these measures are 
weighted appropriately, or whether a different weighting distribution, 
such as equal distribution across all measures would be better suited 
to this program and this proposed scoring methodology. We are also 
seeking public comment on other scoring methodologies such as the 
alternative we considered and outlined earlier in this section.

             Table 38--Proposed Scoring Methodology for the MIPS Performance Period in 2019 Example
----------------------------------------------------------------------------------------------------------------
                                                        Maximum     Numerator/   Performance
            Objective                  Measures          points    denominator    rate (%)           Score
----------------------------------------------------------------------------------------------------------------
e-Prescribing...................  e-Prescribing.....           10      200/250            80  10 * 0.8 = 8
                                                                                               points.
                                  Query of                      5      150/175            86  5 bonus points.
                                   Prescription Drug
                                   Monitoring
                                   Program.
                                  Verify Opioid                 5          N/A           N/A  0 points.
                                   Treatment
                                   Agreement.

[[Page 35918]]

 
Health Information Exchange.....  Support Electronic           20      135/185            73  20 * 0.73 = 15
                                   Referral Loops by                                           points.
                                   Sending Health
                                   Information.
                                  Support Electronic           20      145/175            83  20 * 0.83 = 17
                                   Referral Loops by                                           points.
                                   Receiving and
                                   Incorporating
                                   Health
                                   Information.
Provider to Patient Exchange....  Provide Patients             40      350/500            70  40 * 0.70 = 28
                                   Electronic Access                                           points.
                                   to Their Health
                                   Information.
Public Health and Clinical Data   Immunization                 10          Yes           N/A  10 points.
 Exchange.                         Registry
                                   Reporting.
                                  Public Health       ...........          Yes           N/A  10 points.
                                   Registry
                                   Reporting.
                                                     -----------------------------------------------------------
    Total Score.................  ..................  ...........  ...........  ............  83 points.
----------------------------------------------------------------------------------------------------------------

    If we do not finalize a new scoring methodology, we propose to 
maintain for the performance period in 2019 the current Promoting 
Interoperability performance category scoring methodology with the same 
objectives, measures and requirements as established for the 
performance period in 2018, except that we would discontinue the 2018 
Promoting Interoperability Transition Objectives and Measures (82 FR 
53677). We would discontinue the use of the transition measures because 
they are associated with 2014 Edition CEHRT and we are requiring the 
use of 2015 Edition CEHRT solely beginning with the performance period 
in 2019. For more information, we refer readers to the CY 2018 Quality 
Payment Program final rule (82 FR 53663 through 53680). In addition, we 
propose to include the 2 new opioid measures, if finalized. We refer 
readers to section III.H.3.h.(5)(f) of this proposed rule for a 
discussion of the measure proposals.
    We also are seeking public comment on the feasibility of the 
proposed new scoring methodology in 2019 and whether MIPS eligible 
clinicians would be able to implement the new measures and reporting 
requirements under this scoring methodology. In addition, in section 
III.H.3.h.(5) of this proposed rule, we are seeking public comment on 
how the Promoting Interoperability performance category should evolve 
in future years regarding the new scoring methodology and related 
aspects of the program.
    We are proposing to codify the proposed new scoring methodology in 
new paragraphs (b)(4)(ii) and (iii) under Sec.  414.1380.
(e) Promoting Interoperability/Advancing Care Information Objectives 
and Measures Specifications for the 2018 Performance Period
    The Advancing Care Information (now Promoting Interoperability) 
performance category Objectives and Measures for the 2018 performance 
period are as follows. For more information, we refer readers to the CY 
2017 and CY 2018 Quality Payment Program final rules (81 FR 77227 
through 77229, and 82 FR 53674 through 53680, respectively).
    Objective: Protect Patient Health Information.
    Objective: Protect electronic protected health information (ePHI) 
created or maintained by the CEHRT through the implementation of 
appropriate technical, administrative, and physical safeguards.
    Security Risk Analysis Measure: Conduct or review a security risk 
analysis in accordance with the requirements in 45 CFR 164.308(a)(1), 
including addressing the security (to include encryption) of ePHI data 
created or maintained by CEHRT in accordance with requirements in 45 
CFR 164.312(a)(2)(iv) and 164.306(d)(3), implement security updates as 
necessary, and correct identified security deficiencies as part of the 
MIPS eligible clinician's risk management process.
    Objective: Electronic Prescribing.
    Objective: Generate and transmit permissible prescriptions 
electronically.
    e-Prescribing Measure: At least one permissible prescription 
written by the MIPS eligible clinician is queried for a drug formulary 
and transmitted electronically using CEHRT.
    Denominator: Number of prescriptions written for drugs requiring a 
prescription in order to be dispensed other than controlled substances 
during the performance period; or number of prescriptions written for 
drugs requiring a prescription in order to be dispensed during the 
performance period.
    Numerator: The number of prescriptions in the denominator 
generated, queried for a drug formulary, and transmitted electronically 
using CEHRT.
    Exclusion: Any MIPS eligible clinician who writes fewer than 100 
permissible prescriptions during the performance period.
    Objective: Patient Electronic Access.
    Objective: The MIPS eligible clinician provides patients (or 
patient-authorized representative) with timely electronic access to 
their health information and patient-specific education.
    Patient Access Measure: For at least one unique patient seen by the 
MIPS eligible clinician: (1) The patient (or the patient-authorized 
representative) is provided timely access to view online, download, and 
transmit his or her health information; and (2) The MIPS eligible 
clinician ensures the patient's health information is available for the 
patient (or patient-authorized representative) to access using any 
application of their choice that is configured to meet the technical 
specifications of the Application Programing Interface (API) in the 
MIPS eligible clinician's CEHRT.
    Denominator: The number of unique patients seen by the MIPS 
eligible clinician during the performance period.
    Numerator: The number of patients in the denominator (or patient 
authorized representative) who are provided timely access to health 
information to view online, download, and transmit to a third party and 
to access using an application of their choice that is configured meet 
the technical specifications of the API in the MIPS eligible 
clinician's CEHRT.
    Patient-Specific Education Measure: The MIPS eligible clinician 
must use clinically relevant information from CEHRT to identify 
patient-specific educational resources and provide electronic access to 
those materials to at least one unique patient seen by the MIPS 
eligible clinician.
    Denominator: The number of unique patients seen by the MIPS 
eligible

[[Page 35919]]

clinician during the performance period.
    Numerator: The number of patients in the denominator who were 
provided electronic access to patient-specific educational resources 
using clinically relevant information identified from CEHRT during the 
performance period.
    Objective: Coordination of Care Through Patient Engagement.
    Objective: Use CEHRT to engage with patients or their authorized 
representatives about the patient's care.
    View, Download, Transmit (VDT) Measure: During the performance 
period, at least one unique patient (or patient-authorized 
representatives) seen by the MIPS eligible clinician actively engages 
with the EHR made accessible by the MIPS eligible clinician by either: 
(1) Viewing, downloading or transmitting to a third party their health 
information; or (2) accessing their health information through the use 
of an API that can be used by applications chosen by the patient and 
configured to the API in the MIPS eligible clinician's CEHRT; or (3) a 
combination of (1) and (2).
    Denominator: Number of unique patients seen by the MIPS eligible 
clinician during the performance period.
    Numerator: The number of unique patients (or their authorized 
representatives) in the denominator who have viewed online, downloaded, 
or transmitted to a third party the patient's health information during 
the performance period and the number of unique patients (or their 
authorized representatives) in the denominator who have accessed their 
health information through the use of an API during the performance 
period.
    Secure Messaging Measure: For at least one unique patient seen by 
the MIPS eligible clinician during the performance period, a secure 
message was sent using the electronic messaging function of CEHRT to 
the patient (or the patient-authorized representative), or in response 
to a secure message sent by the patient (or the patient-authorized 
representative).
    Denominator: Number of unique patients seen by the MIPS eligible 
clinician during the performance period.
    Numerator: The number of patients in the denominator for whom a 
secure electronic message is sent to the patient (or patient-authorized 
representative) or in response to a secure message sent by the patient 
(or patient-authorized representative), during the performance period.
    Patient-Generated Health Data Measure: Patient-generated health 
data or data from a non-clinical setting is incorporated into the CEHRT 
for at least one unique patient seen by the MIPS eligible clinician 
during the performance period.
    Denominator: Number of unique patients seen by the MIPS eligible 
clinician during the performance period.
    Numerator: The number of patients in the denominator for whom data 
from non-clinical settings, which may include patient-generated health 
data, is captured through the CEHRT into the patient record during the 
performance period.
    Objective: Health Information Exchange.
    Objective: The MIPS eligible clinician provides a summary of care 
record when transitioning or referring their patient to another setting 
of care, receives or retrieves a summary of care record upon the 
receipt of a transition or referral or upon the first patient encounter 
with a new patient, and incorporates summary of care information from 
other health care providers into their EHR using the functions of 
CEHRT.
    Send a Summary of Care Measure: For at least one transition of care 
or referral, the MIPS eligible clinician that transitions or refers 
their patient to another setting of care or health care provider (1) 
creates a summary of care record using CEHRT; and (2) electronically 
exchanges the summary of care record.
    Denominator: Number of transitions of care and referrals during the 
performance period for which the MIPS eligible clinician was the 
transferring or referring clinician.
    Numerator: The number of transitions of care and referrals in the 
denominator where a summary of care record was created using CEHRT and 
exchanged electronically.
    Exclusion: Any MIPS eligible clinician who transfers a patient to 
another setting or refers a patient is fewer than 100 times during the 
performance period.
    Request/Accept Summary of Care Measure: For at least one transition 
of care or referral received or patient encounter in which the MIPS 
eligible clinician has never before encountered the patient, the MIPS 
eligible clinician receives or retrieves and incorporates into the 
patient's record an electronic summary of care document.
    Denominator: Number of patient encounters during the performance 
period for which a MIPS eligible clinician was the receiving party of a 
transition or referral or has never before encountered the patient and 
for which an electronic summary of care record is available.
    Numerator: Number of patient encounters in the denominator where an 
electronic summary of care record received is incorporated by the 
clinician into the CEHRT.
    Exclusion: Any MIPS eligible clinician who receives transitions of 
care or referrals or has patient encounters in which the MIPS eligible 
clinician has never before encountered the patient fewer than 100 times 
during the performance period.
    Clinical Information Reconciliation Measure: For at least one 
transition of care or referral received or patient encounter in which 
the MIPS eligible clinician has never before encountered the patient, 
the MIPS eligible clinician performs clinical information 
reconciliation. The MIPS eligible clinician must implement clinical 
information reconciliation for the following three clinical information 
sets: (1) Medication. Review of the patient's medication, including the 
name, dosage, frequency, and route of each medication; (2) Medication 
allergy. Review of the patient's known medication allergies; and (3) 
Current Problem list. Review of the patient's current and active 
diagnoses.
    Denominator: Number of transitions of care or referrals during the 
performance period for which the MIPS eligible clinician was the 
recipient of the transition or referral or has never before encountered 
the patient.
    Numerator: The number of transitions of care or referrals in the 
denominator where the following three clinical information 
reconciliations were performed: Medication list; medication allergy 
list; and current problem list.
    Objective: Public Health and Clinical Data Registry Reporting.
    Objective: The MIPS eligible clinician is in active engagement with 
a public health agency or clinical data registry to submit electronic 
public health data in a meaningful way using CEHRT, except where 
prohibited, and in accordance with applicable law and practice.
    Immunization Registry Reporting Measure: The MIPS eligible 
clinician is in active engagement with a public health agency to submit 
immunization data and receive immunization forecasts and histories from 
the public health immunization registry/immunization information system 
(IIS).
    Syndromic Surveillance Reporting Measure: The MIPS eligible 
clinician is in active engagement with a public health agency to submit 
syndromic surveillance data from an urgent care setting.

[[Page 35920]]

    Electronic Case Reporting Measure: The MIPS eligible clinician is 
in active engagement with a public health agency to electronically 
submit case reporting of reportable conditions.
    Public Health Registry Reporting Measure: The MIPS eligible 
clinician is in active engagement with a public health agency to submit 
data to public health registries.
    Clinical Data Registry Reporting Measure: The MIPS eligible 
clinician is in active engagement to submit data to a clinical data 
registry.
(f) Promoting Interoperability Performance Category Measure Proposals 
for MIPS Eligible Clinicians
(i) Measure Proposal Summary Overview
    We are proposing to adopt beginning with the performance period in 
2019 the existing Promoting Interoperability objectives and measures as 
finalized in the CY 2018 Quality Payment Program final rule (82 FR 
53674 through 53680) with several proposed changes as discussed herein, 
including the addition of new measures, removal of some of the existing 
measures, and modifications to the specifications of some of the 
existing measures. We are not proposing to continue the Promoting 
Interoperability transition objectives and measures (see 82 FR 53674 
through 53676) beyond the 2018 MIPS performance period because the 2015 
Edition of CEHRT will be required beginning with the MIPS performance 
period in 2019. Our intent for these proposed changes is to ensure the 
measures better focus on the effective use of health IT, particularly 
for interoperability, and to address concerns stakeholders have raised 
through public forums and in public comments related to the perceived 
burden associated with the current measures in the program. As stated 
in the CY 2017 Quality Payment Program final rule (81 FR 77216) our 
priority is to finalize reporting requirements for the Promoting 
Interoperability performance category that incentivizes performance and 
reporting with minimal complexity and reporting burden. In addition, we 
acknowledged that while we believe all of the measures of the Promoting 
Interoperability performance category are important, we must also 
balance the need for these data with data collection and reporting 
burden (81 FR 77221).
    In CY 2017, we initiated an informal process outside of rulemaking 
for submission of new Promoting Interoperability performance category 
measures for potential inclusion in the Year 3 Quality Payment Program 
proposed rule. We prioritized measures that build on interoperability 
and health information exchange, the advanced use of CEHRT using 2015 
Edition Standards and Certification Criteria, improve program 
efficiency and flexibility, measure patient outcomes, emphasize patient 
safety, and support improvement activities and quality performance 
categories of MIPS. In addition, and as we indicated in the CY 2018 
Quality Payment Program proposed rule (82 FR 30079), we sought new 
measures that may be more broadly applicable to MIPS eligible 
clinicians who are Nurse Practitioners (NPs), Physician Assistants 
(PAs), Certified Registered Nurse Anesthetists (CRNAs) and Clinical 
Nurse Specialists (CNSs).
    During this initial submission period, various MIPS eligible 
clinicians, stakeholders and health IT developers submitted new 
measures for consideration via an application posted on the CMS 
website, now hosted at https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/CallForMeasures.html. Through our 
review process, which included representation from the ONC, as well as 
various stakeholder listening sessions, we identified measure 
submissions that met our criteria and aligned with the Promoting 
Interoperability performance category goals and priorities, as well as 
broader HHS initiatives related to the opioid crisis.\18\ As a result 
of this process, we are proposing two measures, Query of PDMP and 
Verify Opioid Treatment Agreement.
---------------------------------------------------------------------------

    \18\ https://www.hhs.gov/opioids/about-the-epidemic/; 
https://www.healthit.gov/opioids.
---------------------------------------------------------------------------

    We are proposing to remove six measures from the Promoting 
Interoperability objectives and measures beginning with the performance 
period in 2019. Two of the measures we are proposing to remove--
Request/Accept Summary of Care and Clinical Information 
Reconciliation--would be replaced by the Support Electronic Referral 
Loops by Receiving and Incorporating Health Information measure, which 
combines the functionalities and goals of the two measures it is 
replacing. Four of the measures--Patient-Specific Education; Secure 
Messaging; View, Download, or Transmit; and Patient-Generated Health 
Data--would be removed because they have proven burdensome to MIPS 
eligible clinicians in ways that were unintended and may detract from 
clinicians' progress on current program priorities. While the measures 
proposed for removal would no longer need to be submitted if we 
finalize the proposal to remove them, MIPS eligible clinicians may 
still continue to use the standards and functions of those measures 
based on the preferences of their patients and their practice needs. We 
believe that this burden reduction would enable MIPS eligible 
clinicians to focus on new measures that further interoperability, 
advances of innovation in the use of CEHRT and the exchange of health 
care information.
    As discussed in the proposed scoring methodology in section 
III.H.3.h.(5)(f) of this proposed rule, we are proposing to add three 
new measures to the Promoting Interoperability objectives and measures 
beginning with the performance period in 2019. For the e-Prescribing 
objective, we are proposing the two new measures referenced above, 
Query of PDMP and Verify Opioid Treatment Agreement, both of which 
support HHS initiatives related to the treatment of opioid and 
substance use disorders by helping health care providers avoid 
inappropriate prescriptions, improving coordination of prescribing 
amongst health care providers and focusing on the advanced use of 
CEHRT. For the Health Information Exchange objective, we are proposing 
a new measure, Support Electronic Referral Loops by Receiving and 
Incorporating Health Information, which builds upon and replaces the 
existing Request/Accept Summary of Care and Clinical Information 
Reconciliation measures, while furthering interoperability and the 
exchange of health information.
    We are also proposing to modify some of the existing Promoting 
Interoperability objectives and measures beginning with the performance 
period in 2019. We are proposing to rename the Send a Summary of Care 
measure to Support Electronic Referral Loops by Sending Health 
Information. In addition, we are proposing to rename the Patient 
Electronic Access objective to Provider to Patient Exchange, and 
proposing to rename the remaining measure, Provide Patient Access to 
Provide Patients Electronic Access to Their Health Information. We are 
proposing to eliminate the Coordination of Care Through Patient 
Engagement objective and all of its associated measures as described 
above. Finally, we are proposing to rename the Public Health and 
Clinical Data Registry Reporting objective to Public Health and 
Clinical Data Exchange and require reporting on at least two measures 
of the MIPS eligible clinician's choice from the following: 
Immunization Registry Reporting; Syndromic Surveillance Reporting, 
Electronic Case Reporting;

[[Page 35921]]

Public Health Registry Reporting; and Clinical Data Registry Reporting. 
In addition, we are proposing exclusion criteria for each of these 
measures.
    Finally, we are seeking comment on a potential new measure Health 
Information Exchange Across the Care Continuum under the Health 
Information Exchange objective in which a MIPS eligible clinician would 
send an electronic summary of care record, or receive and incorporate 
an electronic summary of care record, for transitions of care and 
referrals with a health care provider other than a MIPS eligible 
clinician. The measure would include health care providers in care 
settings including but not limited to long term care facilities and 
post-acute care providers such as skilled nursing facilities, home 
health, and behavioral health settings.
    Table 39 provides a summary of these measures proposals.

    Table 39--Summary of Proposals for the Promoting Interoperability
  Performance Category Objectives and Measures for the MIPS Performance
                             Period in 2019
------------------------------------------------------------------------
          Measure status                           Measure
------------------------------------------------------------------------
Measures retained--no                e-Prescribing.
 modifications *.
Measures retained with               Send a Summary of Care
 modifications.                      (name proposal--Support Electronic
                                     Referral Loops by Sending Health
                                     Information).
                                     Provide Patient Access
                                     (name proposal--Provide Patients
                                     Electronic Access to Their Health
                                     Information).
                                     Immunization Registry
                                     Reporting.
                                     Syndromic Surveillance
                                     Reporting.
                                     Electronic Case Reporting.
                                     Public Health Registry
                                     Reporting.
                                     Clinical Data Registry
                                     Reporting.
Removed measures..................   Request/Accept Summary of
                                     Care.
                                     Clinical Information
                                     Reconciliation.
                                     Patient-Specific Education.
                                     Secure Messaging.
                                     View, Download or Transmit.
                                     Patient-Generated Health
                                     Data.
New measures......................   Query of Prescription Drug
                                     Monitoring Program (PDMP).
                                     Verify Opioid Treatment
                                     Agreement.
                                     Support Electronic Referral
                                     Loops--Receiving and Incorporating
                                     Health Information.
------------------------------------------------------------------------
* Security Risk Analysis is retained, but not included as a measure
  under the proposed scoring methodology.

    We understand from previous listening sessions that EHR vendors and 
developers would need time to develop, test and implement new measures, 
and MIPS eligible clinicians would need time to implement as well as 
establish and test their processes and workflows. As indicated above 
and in the discussion of the proposed scoring methodology in section 
III.H.3.h.(5)(d) of this proposed rule, we are proposing three new 
measures (Query of PDMP, Verify Opioid Treatment Agreement, and Support 
Electronic Referral Loops by Receiving and Incorporating Health 
Information). We are proposing that the Query of PDMP and Verify Opioid 
Treatment Agreement measures would be optional for the performance 
period in 2019 and bonus points may be earned for reporting on them. We 
are proposing that the Support Electronic Referral Loops by Receiving 
and Incorporating Health Information would be required beginning with 
the performance period in 2019 with an exclusion available. We are 
proposing to require the Query of PDMP and Verify Opioid Treatment 
Agreement measures beginning with the performance period in 2020, and 
we are seeking public comment on this proposal. The proposals under the 
Health Information Exchange objective require only consolidation of 
existing workflows and actions, while certification criteria and 
standards remain the same as in the CY 2018 Quality Payment Program 
final rule (82 FR 53677 through 53678). Therefore, we believe MIPS 
eligible clinicians could potentially implement this new measure for 
the performance period in 2019.
(ii) Measure Proposals for the e-Prescribing Objective
    Based on our review of the submissions we received through the 
informal measure submission process described in the preceding section, 
and considerations of overall agency priorities as discussed below, we 
are proposing two new measures under the e-Prescribing objective. In 
the CY 2017 Quality Payment Program final rule, we stated that MIPS 
eligible clinicians would have the option to include or not include 
controlled substances in the definition of ``permissible 
prescriptions'' at their discretion where feasible and allowable by law 
in the jurisdiction where they provide care (81 FR 77227). We believe 
it is important to consider other requirements specific to electronic 
prescribing of controlled substances for health care providers to take 
into account and how this may interact with the proposals under this 
rulemaking. CMS is committed to combatting the opioid epidemic by 
making it a top priority for the agency and aligning its efforts with 
the HHS opioid initiative to combat misuse and promote programs that 
support treatment and recovery support services. The HHS five-point 
Opioid Strategy aims to:
     Improve access to prevention, treatment, and recovery 
support services to prevent the health, social, and economic 
consequences associated with opioid addiction and to enable individuals 
to achieve long-term recovery;
     Target the availability and distribution of overdose-
reversing drugs to ensure the provision of these drugs to people likely 
to experience or respond to an overdose, with a particular focus on 
targeting high-risk populations;
     Strengthen public health data reporting and collection to 
improve the timeliness and specificity of data and to inform a real-
time public health response;
     Support cutting-edge research that advances our 
understanding of pain and addiction, leads to the development of new 
treatments, and identifies effective

[[Page 35922]]

public health interventions to reduce opioid-related health harms; and
     Advance the practice of pain management to enable access 
to high-quality, evidence-based pain care that reduces the burden of 
pain for individuals, families, and society while also reducing the 
inappropriate use of opioids and opioid-related harms.
    CMS' strategy includes reducing the risk of opioid use disorders, 
overdoses, inappropriate prescribing practices and drug diversion. We 
have identified two new measures which align with the broader HHS 
efforts to increase the use of PDMPs to reduce inappropriate 
prescriptions, improve patient outcomes and promote more informed 
prescribing practices.
    We are proposing to add two new measures to the e-Prescribing 
objective that are based on electronic prescriptions for controlled 
substances (EPCS): Query of PDMP; and Verify Opioid Treatment 
Agreement. These measures build upon the meaningful use of CEHRT as 
well as the security of electronic prescribing of Schedule II 
controlled substances while preventing diversion. For both measures, we 
are proposing to define opioids as Schedule II controlled substances 
under 21 CFR 1308.12, as they are recognized as having a high potential 
for abuse with potential for severe psychological or physical 
dependence. We are also proposing to apply the same policies for the 
existing e-Prescribing measure to both the Query of PDMP and Verify 
Opioid Treatment Agreement measures, including the requirement to use 
CEHRT as the sole means of creating the prescription and for 
transmission to the pharmacy. MIPS eligible clinicians have the option 
to include or exclude controlled substances in the e-Prescribing 
measure denominator as long as they are treated uniformly across 
patients and all available schedules and in accordance with applicable 
law (81 FR 77227). However, because the intent of these two new 
measures is to improve prescribing practices for controlled substances, 
MIPS eligible clinicians would have to include Schedule II opioid 
prescriptions in the numerator and denominator or claim the applicable 
exclusion. Additionally, the intent of the proposed measures is not to 
dissuade the prescribing or use of opioids for patients with medical 
diagnoses or conditions that benefit from their use, such as patients 
diagnosed with cancer or those receiving hospice. We seek comment on 
the impact that implementing this measure could have on patients who 
receive opioids due to medical diagnoses such as cancer or receiving 
hospice care as well as treatment of patients under a program involving 
substance abuse education, treatment, or prevention under 42 CFR part 
2. Additionally, we seek comment on the federal and state statutory and 
regulatory requirements that may impact implementation of the Query of 
PDMP and Verify Opioid Treatment Agreement measures.
    In the event we finalize the new scoring methodology that we are 
proposing in section III.H.3.h.(5)(d) of this proposed rule, MIPS 
eligible clinicians who claim the exclusion under the existing e-
Prescribing measure would automatically receive an exclusion for all 
three of the measures under the e-Prescribing objective; they would not 
have to also claim exclusions for the other two measures, Query of PDMP 
and Verify Opioid Treatment Agreement.
    In the event we do not finalize the new scoring methodology 
proposed in section III.H.3.h(5)(d) of this proposed rule, but we do 
finalize the proposed measures of Query of PDMP and Verify Opioid 
Treatment Agreement under the e-Prescribing objective, we propose to 
include them under the bonus score with each measure being worth 5 
percentage points, but we would not include exclusion criteria as 
reporting would be optional under the scoring methodology finalized in 
previous rulemaking (81 FR 77216 through 77227 and 82 FR 53663 through 
53664). We believe these measures should be part of the bonus score 
because not all MIPS eligible clinicians are able to prescribe 
controlled substances, and therefore these measures may not be 
applicable to them. Additionally, in the event we do not finalize the 
proposed scoring methodology, we would retain the existing e-
Prescribing measure (with its exclusion) as a base score requirement.
(A) Proposed Measure: Query of Prescription Drug Monitoring Program 
(PDMP)
    A PDMP is an electronic database that tracks prescriptions of 
controlled substances at the State level. PDMPs play an important role 
in patient safety by assisting in the identification of patients who 
have multiple prescriptions for controlled substances or may be 
misusing or overusing them. Querying the PDMP is important for tracking 
the prescribed controlled substances and improving prescribing 
practices. The ONC, Centers for Disease Control and Prevention (CDC), 
Department of Justice (DOJ) and Substance Abuse and Mental Health 
Services Administration (SAMHSA) have had integral roles in the 
integration and expansion of PMDPs with health information technology 
systems. For example, the ONC and SAMHSA collaboratively led the 
``Enhancing Access'' project to improve health care provider access to 
PDMP data utilizing health IT.\19\ Likewise, the CDC conducted a 
process and outcome evaluation of the PDMP EHR Integration and 
Interoperability Expansion (PEHRIIE) program funded by SAMHSA for nine 
states between FY 2012 and 2016. The PEHRIIE program goals were to 
integrate PDMPs into health IT and improve the comprehensiveness of 
PDMPs through initiating and/or improving interstate data exchange.\20\ 
In addition, the Bureau of Justice Assistance's Harold Rogers 
Prescription Monitoring Program supports Prescription Drug Monitoring 
Program Information Exchange (PMIX) through funding, the goal of PMIX 
is to help states implement a cost-effective solution to facilitate 
interstate data sharing among PDMPs.\21\ Integration of the PDMP with 
health information technology systems supports improves access to PDMP 
data, minimizes changes to current workflow and overall burden and 
optimizes prescribing practices. The intent of the Query of the PDMP 
measure is to build upon the current PDMP initiatives from Federal 
partners focusing on prescriptions generated and dispensing of opioids.
---------------------------------------------------------------------------

    \19\ https://www.healthit.gov/PDMP and https://www.healthit.gov/sites/default/files/work_group_document_integrated_paper_final_0.pdf.
    \20\ https://www.cdc.gov/drugoverdose/pdf/pehriie_report-a.pdf.
    \21\ https://www.bja.gov/funding/Category-5-awards.pdf.
---------------------------------------------------------------------------

    Proposed Measure Description: For at least one Schedule II opioid 
electronically prescribed using CEHRT during the performance period, 
the MIPS eligible clinician uses data from CEHRT to conduct a query of 
a Prescription Drug Monitoring Program (PDMP) for prescription drug 
history, except where prohibited and in accordance with applicable law.
    CMS recognizes both the utility and value of addressing PDMP EHR 
integration and further recognizes the majority of states mandate use 
of State prescription monitoring programs (PMPs) requiring prescribers/
dispensers to access PMP.\22\ According to the CDC, State-level 
policies that enhance PDMPs or regulate pain clinics helped several 
states drive down opioid prescriptions and overdose deaths.\23\ We are 
also further aware of the varying integration

[[Page 35923]]

approaches underway including efforts to integrate a state PDMP into a 
health information exchange or EHR or other efforts to enhance a user 
interface of some type, such as risk assessment tools or red flags. We 
note federal evaluation resources available to inform integration 
efforts \24\ and believe integration is critical for enhancing health 
care provider workflow, access to critical PDMP data, and improving 
clinical care including prescription management.
---------------------------------------------------------------------------

    \22\ https://www.namsdl.org/library/14D3122C-96F5-F53E-E8F23E906B4DE09D/.
    \23\ https://www.cdc.gov/drugoverdose/policy/successes.html.
    \24\ https://www.cdc.gov/drugoverdose/pdf/pehriie_report-a.pdf.
---------------------------------------------------------------------------

    We are proposing that the query of the PDMP for prescription drug 
history must be conducted prior to the electronic transmission of the 
Schedule II opioid prescription. MIPS eligible clinicians would have 
flexibility to query the PDMP using CEHRT in any manner allowed under 
their State law.
    Although the query of the PDMP may currently be burdensome for some 
MIPS eligible clinicians as part of their current workflow practice, we 
believe querying the PDMP is beneficial to optimal prescribing 
practices and foresee progression toward fully automated queries of the 
PDMP building upon the current initiatives at the State level.
    We are proposing to include in this measure all permissible 
prescriptions and dispensing of Schedule II opioids regardless of the 
amount prescribed during an encounter in order for MIPS eligible 
clinicians to identify multiple health care provider episodes 
(physician shopping), prescriptions of dangerous combinations of drugs, 
prescribing rates and controlled substances prescribed in high 
quantities. We request comment on these policy proposals, including 
whether additional queries should be performed and under which 
circumstances. In addition we seek comment on whether the query should 
have additional constraints concerning when it should be performed.
    Denominator: Number of Schedule II opioids electronically 
prescribed using CEHRT by the MIPS eligible clinician during the 
performance period.
    Numerator: The number of Schedule II opioid prescriptions in the 
denominator for which data from CEHRT is used to conduct a query of a 
PDMP for prescription drug history except where prohibited and in 
accordance with applicable law. A numerator of at least one is required 
to fulfill this measure.
    Exclusion (beginning in 2020): Any MIPS eligible clinician who is 
unable to electronically prescribe Schedule II opioids in accordance 
with applicable law during the performance period. We propose that the 
exclusion criteria would be limited to prescriptions of Schedule II 
opioids as the measure action is limited to prescriptions of Schedule 
II opioids only and does not include any other types of electronic 
prescriptions. We are also requesting comment on the proposed exclusion 
criteria and whether there are circumstances which may justify other 
exclusions for the Query of PDMP measure and what those circumstances 
might be including medical diagnoses such as cancer or patients under 
care of hospice.
    We also understand that PDMP integration is not currently in 
widespread use for CEHRT, and many MIPS eligible clinicians may require 
additional time and workflow changes at the point of care before they 
can meet this measure without experiencing significant burden. For 
instance, many MIPS eligible clinicians will likely need to manually 
enter the data into CEHRT to document the completion of the query of 
the PDMP action. In addition, some MIPS eligible clinicians may also 
need to conduct manual calculation of the measure. Even for those MIPS 
eligible clinicians that have achieved successful integration of a PDMP 
with their EHR, this measure may not be machine calculable, for 
instance, in cases where the MIPS eligible clinician follows a link 
within the EHR to a separate PDMP system. For the purposes of meeting 
this measure, we also understand that there is no existing 
certification criteria for the query of a PDMP. However, we believe 
that the use of structured data captured in the CEHRT can support 
querying a PDMP through the broader use of health IT. We seek public 
comment on whether ONC should consider adopting standards and 
certification criteria to support the query of a PDMP, and if such 
criteria were to be adopted, on what timeline should CMS require their 
use to meet this measure.
    The NCPDP SCRIPT 2017071 standard for e-prescribing is now 
available and can help to support PDMP and EHR integration. We are 
seeking public comment, especially from health care providers and 
health IT developers on whether they believe use of this standard can 
support MIPS eligible clinicians seeking to report on this measure, and 
whether HHS should encourage use of this standard through separate 
rulemaking.
    We seek comment on the challenges associated with querying the PDMP 
with and without CEHRT integration and whether this proposed measure 
should require certain standards, methods or functionalities to 
minimize burden.
    In including EPCS as a component of the measure as proposed, we 
acknowledge and seek input on perceived and real technological barriers 
as part of its effective implementation including but not limited to 
input on two-factor authentication and on the effective and appropriate 
uses of technology, including the use of telehealth modalities to 
support established patient and health care provider relationships 
subsequent to in-person visit(s) and for prescribing purposes.
    In the event we do not finalize the proposed scoring methodology, 
we are proposing MIPS eligible clinicians must report at least one 
prescription in the numerator to report on this new measure and earn 
points towards the bonus score. We believe a threshold of at least one 
prescription is appropriate because varying State laws related to 
integration of the PDMP into CEHRT can lead to differing standards for 
querying.
    We are also proposing that in order to meet this measure, a MIPS 
eligible clinician must use the capabilities and standards as defined 
for CEHRT at 45 CFR 170.315(a)(10)(ii) and (b)(3).
(B) Proposed Measure: Verify Opioid Treatment Agreement
    The intent of this measure is for MIPS eligible clinicians to 
identify whether there is an existing opioid treatment agreement when 
they electronically prescribe a Schedule II opioid using CEHRT if the 
total duration of the patient's Schedule II opioid prescriptions is at 
least 30 cumulative days. We believe seeking to identify an opioid 
treatment agreement will further efforts to coordinate care between 
health care providers and foster a more informed review of patient 
therapy. The intent of the treatment agreement is to clearly outline 
the responsibilities of both patient and MIPS eligible clinician in the 
treatment plan. Such a treatment plan can be integrated into care 
coordination and care plan activities and documents as discussed and 
agreed upon by the patient and MIPS eligible clinician. An opioid 
treatment agreement is intended to support and to enable further 
coordination and the sharing of substance use disorder (SUD) data with 
consent, as may be required of the individual.
    According to the American Journal of Psychiatry article 
Prescription Opioid Misuse, Abuse, and Treatment in the

[[Page 35924]]

United States: An Update,\25\ patient and health care provider 
treatment agreements are part of the recommendations to enhance efforts 
to prevent opioid abuse per the Office of the National Drug Control 
Policy's National Drug Control Strategy.\26\ The article further 
indicates that the treatment agreement can be beneficial as it provides 
clear information for the agreed upon pain management plan, preventing 
misconceptions.
---------------------------------------------------------------------------

    \25\ Brady, K.T., McCauley, J,L,, Back, S.E. Prescription Opioid 
Misuse, Abuse, and Treatment in the United States: An Update, 
American Journal of Psychiatry, Volume 173, Issue 1, January 01, 
2016, pp. 18-26. Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4782928/.
    \26\ https://obamawhitehouse.archives.gov/ondcp/policy-and-research/ndcs.
---------------------------------------------------------------------------

    An article in Pain Medicine, Universal Precautions in Pain 
Medicine: A Rational Approach to the Treatment of Chronic Pain also 
includes treatment agreements as part of the ``Ten Steps of Universal 
Precautions in Pain Medicine'' which are stated to be recommended 
starting points for discussion in the treatment of chronic pain.\27\
---------------------------------------------------------------------------

    \27\ Gourlay, D.L., Heit, H.A., Almahrezi, A. ``Universal 
Precautions in Pain Medicine: A Rational Approach to the Treatment 
of Chronic Pain.'' Pain Medicine, Volume 6, Issue 2, 1 March 2005, 
pp. 107-112. Available at https://academic.oup.com/painmedicine/article/6/2/107/1819946.
---------------------------------------------------------------------------

    We also understand from stakeholder feedback during listening 
sessions that there are varied opinions regarding opioid treatment 
agreements amongst health care providers. Some are supportive of their 
use, indicating that treatment agreements are an important part of the 
prescription of opioids for pain management, and help patients 
understand their role and responsibilities for maintaining compliance 
with terms of the treatment. Other health care providers object to 
their use citing ethical concerns, and creation of division and trust 
issues in the health care provider-patient relationship. Other concerns 
stem from possible disconnect between the language and terminology used 
in the agreement and the level of comprehension on the part of the 
patient. Because of the debate among practitioners, we request comment 
on the challenges this proposed measure may create for MIPS eligible 
clinicians, how those challenges might be mitigated, and whether this 
measure should be included as part of the Promoting Interoperability 
performance category. We also acknowledge challenges related to 
prescribing practices and multiple State laws which may present 
barriers to the uniform implementation of this proposed measure. We are 
seeking public comment on the challenges and concerns associated with 
opioid treatment agreements and how they could impact the feasibility 
of the proposal.
    Proposed Measure Description: For at least one unique patient for 
whom a Schedule II opioid was electronically prescribed by the MIPS 
eligible clinician using CEHRT during the performance period, if the 
total duration of the patient's Schedule II opioid prescriptions is at 
least 30 cumulative days within a 6-month look-back period, the MIPS 
eligible clinician seeks to identify the existence of a signed opioid 
treatment agreement and incorporates it into the patient's electronic 
health record using CEHRT.
    We are proposing this measure would include all Schedule II opioids 
prescribed for a patient electronically using CEHRT by the MIPS 
eligible clinician during the performance period, as well as any 
Schedule II opioid prescriptions identified in the patient's medication 
history request and response transactions during a 6-month look-back 
period, where the total number of days for which a Schedule II opioid 
was prescribed for the patient is at least 30 days.
    There also may be MIPS eligible clinician burdens specific to 
identifying the existence of a treatment agreement which could require 
additional time and changes to existing workflows, determining what 
constitutes a treatment agreement due to a lack of a definition, 
standard or electronic format and manual calculation of the measure. In 
addition, limitations in the completeness of care team information may 
limit the ability of a MIPS eligible clinician to identify all 
potential sources for querying and obtaining information on a treatment 
agreement for a specific patient. There are currently pilots in 
development focused on increasing connectivity and data exchange among 
health care providers to better integrate behavioral health 
information, for instance, pilots taking place as part of the federal 
Demonstration Program for Certified Community Behavioral Health Clinics 
(CCBHC) \28\ includes criteria on how CCBHCs should use health IT to 
coordinate services and track data on quality measures. Participants in 
such pilots would potentially have the means necessary to leverage 
health IT connectivity to query behavioral health data resources and 
health providers within their region to identify the existence of an 
opioid treatment agreement and to successfully integrate patient 
information from the hospital stay into the care plan for the patient. 
We seek comment on other similar pathways to facilitate the 
identification and exchange of treatment agreements and opioid abuse 
treatment planning.
---------------------------------------------------------------------------

    \28\ https://www.samhsa.gov/section-223.
---------------------------------------------------------------------------

    We are proposing the 6-month look-back period would begin on the 
date on which the MIPS eligible clinician electronically transmits 
their Schedule II opioid prescription using CEHRT. For example, all of 
the following prescriptions would be counted for this measure: A 
Schedule II opioid electronically prescribed for a patient for a 
duration of five days by the MIPS eligible clinician using CEHRT during 
the performance period, and four prior prescriptions for any Schedule 
II opioid prescribed by another health care provider (each for a 
duration of seven days) as identified in the patient's medication 
history request and response transactions during the 6-month period 
preceding the date on which the MIPS eligible clinician electronically 
transmits their Schedule II opioid prescription using CEHRT. In this 
example, the total number of days for which a Schedule II opioid was 
prescribed for the patient would equal 33 cumulative days.
    We are proposing a 6-month look-back period to identify more 
egregious cases of potential overutilization of opioids and to cover 
timeframes for use outside the performance period. In addition, we are 
proposing that the 6-month look-back period would utilize at a minimum 
the industry standard NCDCP SCRIPT v10.6 medication history request and 
response transactions codified at Sec.  170.205(b)(2)). As ONC has 
stated (80 FR 62642), adoption of the requirements for NCDCP SCRIPT 
v10.6 does not preclude developers from incorporating and using 
technology standards or services not required by regulation in their 
health IT products.
    We are not proposing to define an opioid treatment agreement as a 
standardized electronic document; nor are we proposing to define the 
data elements, content structure, or clinical purpose for a specific 
document to be considered a ``treatment agreement.'' For this measure, 
we are seeking comment on what characteristics should be part of an 
opioid treatment agreement including data, content and clinical purpose 
into CEHRT, including which functionalities could be utilized to 
accomplish this. We note that a variety of standards available in CEHRT 
might support the electronic exchange of opioid abuse related treatment 
data, such as use of the Consolidated Clinical

[[Page 35925]]

Document Architecture (CCDA) care plan template that is currently 
optional in CEHRT. We are also seeking comment on methods or processes 
for incorporation of the treatment agreement into CEHRT, including 
which functionalities could be utilized to accomplish this task. We 
seek comment on whether there are specific data elements that are 
currently standardized that should be incorporated via reconciliation 
and if the ``patient health data capture'' functionality (45 CFR 
170.315(e)(3)) could be used to incorporate a treatment plan that is 
not a structured document with structured data elements.
    Denominator: Number of unique patients for whom a Schedule II 
opioid was electronically prescribed by the MIPS eligible clinician 
using CEHRT during the performance period and the total duration of 
Schedule II opioid prescriptions is at least 30 cumulative days as 
identified in the patient's medication history request and response 
transactions during a 6-month look-back period.
    Numerator: The number of unique patients in the denominator for 
whom the MIPS eligible clinician seeks to identify a signed opioid 
treatment agreement and, if identified, incorporates the agreement in 
CEHRT. A numerator of at least one is required to fulfill this measure.
    Exclusion (beginning in 2020): Any MIPS eligible clinician who is 
unable to electronically prescribe Schedule II opioids in accordance 
with applicable law during the performance period.
    We propose that the exclusion criteria would be limited to 
prescriptions of Schedule II opioids as the measure action is limited 
to electronic prescriptions of Schedule II opioids only and does not 
include any other types of electronic prescriptions.
    We are requesting comment on the proposed exclusion criteria and 
whether there are additional circumstances that should be added to the 
exclusion criteria and what those circumstances might be including 
medical diagnoses such as cancer or patients under care of hospice.
    We are seeking comment on whether these types of agreements could 
create a burden on clinicians and patients, particularly clinicians who 
serve patients with cancer or those practicing in hospice, as well as 
the patients they serve.
    In the event we do not finalize the proposed scoring methodology, 
we are proposing MIPS eligible clinicians must report at least one 
unique patient in the numerator to report on this new measure and earn 
points towards the bonus score. We believe a threshold of at least one 
unique patient is appropriate to account for the varying support for 
the use of opioid treatment agreements and acknowledging that not all 
patients who receive at least 30 cumulative days of Schedule II opioids 
would have a treatment agreement in place. We also note there are 
medical diagnoses and conditions that could necessitate prescribing 
Schedule II opioids for a cumulative period of more than 30 days 
including medical diagnoses such as cancer or care under hospice.
    We also are proposing that, in order to meet this measure, a MIPS 
eligible clinician must use the capabilities and standards as defined 
for CEHRT at Sec. Sec.  170.315(a)(10) and (b)(3) and 170.205(b)(2).
    As discussed above, we recognize that many health care providers 
are only beginning to adopt electronic prescriptions for controlled 
substances (EPCS) at this time. While we have proposed two new measures 
which combine EPCS with other actions, we request comment on whether 
stakeholders would be interested in a measure focused only on the 
number of Schedule II opioids prescribed and the successful use of EPCS 
for permissible prescriptions electronically prescribed. We seek 
comment about the feasibility of such a measure, and whether 
stakeholders believe this would help to encourage broader adoption of 
EPCS.
(iii) Measure Proposals for the Health Information Exchange Objective
    The Health Information Exchange measures for MIPS eligible 
clinicians hold particular importance because of the role they play 
within the care continuum. In addition, these measures encourage and 
leverage interoperability on a broader scale and promote health IT-
based care coordination. However, through our review of the existing 
measures, we determined that we could potentially improve the measures 
to further reduce burden and better focus the measures on 
interoperability in health care provider to health care provider 
exchange. Such modifications would address a number of concerns raised 
by stakeholders including:
     Supporting the implementation of effective health IT 
supported workflows based on a specific organization's needs;
     Reducing complexity and burden associated with the manual 
tracking of workflows to support health IT measures; and
     Emphasizing within these measures the importance of using 
health IT to support closing the referral loop to improve care 
coordination.
    We believe we can potentially improve the existing Health 
Information Exchange measures to streamline measurement, remove 
redundancy, reduce complexity and burden, and address stakeholders' 
concerns about the focus and impact of the measures on the 
interoperable use of health IT.
    We are proposing several changes to the current measures under the 
Health Information Exchange objective. First, we propose to change the 
name of the Send a Summary of Care measure to Support Electronic 
Referral Loops by Sending Health Information. We also propose to remove 
the Clinical Information Reconciliation measure and combine it with the 
Request/Accept Summary of Care measure to create a new measure, Support 
Electronic Referral Loops by Receiving and Incorporating Health 
Information. This proposed new measure would include actions from both 
the Request/Accept Summary of Care measure and Clinical Information 
Reconciliation measure.
    In the event we do not finalize a new scoring methodology as 
proposed in section III.H.3. h.(5)(d) of this proposed rule, we would 
maintain the existing Health Information Exchange objective, measures 
and reporting requirements as finalized in the CY 2018 Quality Payment 
Program final rule at 82 FR 53674 through 53680.
(A) Proposed Modifications to the Send a Summary of Care Measure
    We are proposing to change the name of the Send a Summary of Care 
measure to Support Electronic Referral Loops by Sending Health 
Information measure, to better reflect the emphasis on completing the 
referral loop and improving care coordination.
    Through public comment and stakeholder correspondence, we have 
become aware that in the health care industry there is some 
misunderstanding of the scope of transitions and referrals which must 
be included in the denominator of this measure. In the event that a 
MIPS eligible clinician is the recipient of a transition of care or 
referral, and subsequent to providing care the MIPS eligible clinician 
transitions or refers the patient back to the referring provider of 
care, this transition of care should be included in the denominator of 
the measure for the MIPS eligible clinician. We expect this will help 
build upon the current provider to provider communication via 
electronic exchange of summary of care records created by CEHRT 
required under this measure, further promote interoperability and care 
coordination with additional health

[[Page 35926]]

care providers, and prevent redundancy in creation of a separate 
measure.
    In the past, stakeholders have raised concerns that the summary 
care records shared according to the CCDA standard included excessive 
information not relevant to immediate care needs, which increased 
burden on health care providers. Under the ONC Health IT Certification 
Program 2015 Edition, CEHRT must have the capability to exchange all of 
the information in the CCDS as part of a summary care record structured 
according to the CCDA standard. We previously finalized in the final 
rule titled ``Medicare and Medicaid Programs Electronic Health Record 
Incentive Program--Stage 2: Health Information Technology, Standards 
Implementation Specifications, and Certification Criteria for 
Electronic Health Record Technology, 2014 Edition; Revisions to the 
Permanent Certification Program for Health Information Technology'' 
(hereafter referred to as the ``Stage 2 final rule'') (77 FR 53991 
through 53993) that health care providers must transmit all of the CCDS 
information as part of this summary care record, if known, and that 
health care providers must always transmit information about the 
problem list, medications, and medication allergies, or validate that 
this information is not known.
    As finalized in the ``Medicare and Medicaid Programs; Electronic 
Health Record Incentive Program--Stage 3 and Modifications to 
Meaningful Use in 2015 Through 2017; Final Rule'' (hereafter referred 
to as the ``2015 EHR Incentive Programs final rule'' (80 FR 62852 
through 62861), our policy allows health care providers to constrain 
the information in the summary care record to support transitions of 
care. For instance, we encouraged health care providers to send a list 
of items that he or she believes to be pertinent and relevant to the 
patient's care, rather than a list of all problems, whether active or 
resolved, that have ever populated the problem list. While a current 
problem list must always be included, the health care provider can use 
his or her judgment in deciding which items historically present on the 
problem list, medical history list (if it exists in CEHRT), or surgical 
history list are relevant given the clinical circumstances.
    We also wish to encourage MIPS eligible clinicians to use the 
document template available within the CCDA which contains the most 
clinically relevant information required by the receiver. Accordingly, 
we are proposing that MIPS eligible clinicians may use any document 
template within the CCDA standard for purposes of the measures under 
the Health Information Exchange objective. While a MIPS eligible 
clinician's CEHRT must be capable of sending the full CCDA upon 
request, we believe this additional flexibility will help support 
clinicians' efforts to ensure the information supporting a transition 
is relevant.
    For instance, when the MIPS eligible clinician is referring to 
another health care provider the recommended document is the ``Referral 
Note'' which is designed to communicate pertinent information from a 
MIPS eligible clinician who is requesting services of another health 
care provider of clinical or non-clinical services. When the receiving 
health care provider sends back the information, the most relevant CCDA 
document template may be the ``Consultation Note,'' which is generated 
by a request from a clinician for an opinion or advice from another 
clinician. While the 2015 Edition transition of care certification 
criterion only requires testing to the Continuity of Care Document and 
Referral Note document templates, we are proposing to allow MIPS 
eligible clinicians the flexibility to use additional CCDA templates 
most appropriate to their clinical workflows. Clinicians would need to 
work with their health IT developer to determine appropriate technical 
workflows and implementation. For more information about the CCDA and 
associated templates, see https://www.hl7.org/documentcenter/public/standards/dstu/CDAR2_IG_CCDA_CLINNOTES_R1_DSTUR2.1_2015AUG.zip.
    In the event we do not finalize a new scoring methodology as 
proposed in section III.H.3.h.(5)(d), we would maintain the current 
Promoting Interoperability performance category objectives, measures 
and reporting requirements as finalized in previous rulemaking. MIPS 
eligible clinicians would be required to report the Send a Summary of 
Care measure as part of the base score as finalized in previous 
rulemaking (82 FR 53674 through 53680).
(B) Proposed Removal of the Request/Accept Summary of Care Measure
    We are proposing to remove the Request/Accept Summary of Care 
measure based on our analysis of the existing measure and in response 
to stakeholder input.
    Through review of implementation practices based on stakeholder 
feedback, we believe that the existing Request/Accept Summary of Care 
measure is not feasible for machine calculation in the majority of 
cases. The intent of the measure is to identify when MIPS eligible 
clinicians are engaging with other providers of care or care team 
members to obtain up-to-date patient health information and to 
subsequently incorporate relevant data into the patient record. 
However, stakeholders have noted the measure specification does not 
effectively further this purpose. Specifically, the existing measure 
specification results in unintended consequences where health care 
providers implement either:
    (1) A burdensome workflow to document the manual action to request 
or obtain an electronic record, for example, clicking a check box to 
document each phone call or similar manual administrative task, or
    (2) A workflow which is limited to only querying internal resources 
for the existence of an electronic document.
    Neither of these two implementation options is desirable when the 
intent of the measure is to incentivize and encourage health care 
providers to implement effective workflows to identify, receive, and 
incorporate patient health information from other health care providers 
into the patient record.
    In addition, our analysis identified that the definition of 
incorporate within the Request/Accept Summary of Care measure is 
insufficient to ensure an interoperable result. When this measure was 
initially finalized in the 2015 EHR Incentive Programs final rule at 80 
FR 62860, we did not define ``incorporate'' as we believed it would 
vary amongst health care provider's workflows, patient population and 
the referring health care provider. In addition, we noted that the 
information could be included as an attachment, as a link within the 
EHR, as imported structured data or reconciled within the record and 
not exclusively performed through use of CEHRT. Further, stakeholder 
feedback highlights the fact that the requirement to incorporate data 
is insufficiently clear regarding what data must be incorporated.
    Our intention was that ``incorporate'' would relate to the 
workflows undertaken in the process of clinical information 
reconciliation further defined in the Clinical Information 
Reconciliation measure (80 FR 62852 through 62862). Taken together, the 
three measures under the Health Information Exchange objective were 
intended to support the referral loop through sending, receiving, and 
incorporating patient health data into the patient record. However, 
stakeholder feedback on the measures suggests that the separation 
between receiving and reconciling patient health

[[Page 35927]]

information is not reflective of clinical and care coordination 
workflows. Further, stakeholders noted, that when approached 
separately, the incorporate portion of the Request/Accept Summary of 
Care measure is both inconsistent with and redundant to the Clinical 
Information Reconciliation measure which causes unnecessary burden and 
duplicative measure calculation.
(C) Proposed Removal of the Clinical Information Reconciliation Measure
    We are proposing to remove the Clinical Information Reconciliation 
measure to reduce redundancy, complexity, and MIPS eligible clinician 
burden.
    We believe the Clinical Information Reconciliation measure is 
redundant in regard to the requirement to ``incorporate'' electronic 
summaries of care in light of the requirements of the Request/Accept 
Summary of Care measure. In addition, the measure is not fully health 
IT based as the exchange of health care information is not required to 
complete the measure action and the measure specification is not 
limited to only the reconciliation of electronic information in health 
IT supported workflows. We stated in the 2015 EHR Incentive Programs 
final rule at 80 FR 62861 that the clinical information reconciliation 
process could involve both automated and manual reconciliation to allow 
the receiving health care provider to work with both electronic data 
received as well as the patient to reconcile their health information. 
Further, stakeholder feedback from hospitals, clinicians, and health IT 
developers indicates that because the measure is not fully based on the 
use of health IT to meet the measurement requirements, health care 
providers must engage in burdensome tracking of manual workflows. While 
the overall activity of clinical information reconciliation supports 
quality patient care and should be a part of effective clinical 
workflows, the process to record and track each individual action 
places unnecessary burden on MIPS eligible clinicians.
(D) Proposed New Measure: Support Electronic Referral Loops by 
Receiving and Incorporating Health Information
    We are proposing to add the following new measure for inclusion in 
the Health Information Exchange objective: Support Electronic Referral 
Loops by Receiving and Incorporating Health Information. This measure 
would build upon and replace the existing Request/Accept Summary of 
Care and Clinical Information Reconciliation measures.
    Proposed name of measure and description: Support Electronic 
Referral Loops by Receiving and Incorporating Health Information: For 
at least one electronic summary of care record received for patient 
encounters during the performance period for which a MIPS eligible 
clinician was the receiving party of a transition of care or referral, 
or for patient encounters during the performance period in which the 
MIPS eligible clinician has never before encountered the patient, the 
MIPS eligible clinician conducts clinical information reconciliation 
for medication, medication allergy, and current problem list.
    We are proposing to combine two existing measures, the Request/
Accept Summary of Care measure and the Clinical Information 
Reconciliation measure, in this new Support Electronic Referral Loops 
by Receiving and Incorporating Health Information measure to focus on 
the exchange of health care information as the current Clinical 
Information Reconciliation measure is not reliant on the exchange of 
health care information to complete the measure action. We are not 
proposing to change the actions associated with the existing measures; 
rather, we are proposing to combine the two measures to focus on the 
exchange of the health care information, reduce administrative burden, 
and streamline and simplify reporting.
    CMS and ONC worked together to define the following for this 
measure:
    Denominator: Number of electronic summary of care records received 
using CEHRT for patient encounters during the performance period for 
which a MIPS eligible clinician was the receiving party of a transition 
of care or referral, and for patient encounters during the performance 
period in which the MIPS eligible clinician has never before 
encountered the patient.
    Numerator: The number of electronic summary of care records in the 
denominator for which clinical information reconciliation is completed 
using CEHRT for the following three clinical information sets: (1) 
Medication--Review of the patient's medication, including the name, 
dosage, frequency, and route of each medication; (2) Medication 
allergy--Review of the patient's known medication allergies; and (3) 
Current Problem List--Review of the patient's current and active 
diagnoses.
    Exclusion: Any MIPS eligible clinician who receives fewer than 100 
transitions of care or referrals or has fewer than 100 encounters with 
patients never before encountered during the performance period.
    We are requesting comment on the proposed exclusion criteria and 
whether there are additional circumstances that should be added to the 
exclusion criteria and what those circumstances might be.
    For the proposed measure, the denominator would increment on the 
receipt of an electronic summary of care record after the MIPS eligible 
clinician engages in workflows to obtain an electronic summary of care 
record for a transition, referral or patient encounter in which the 
MIPS eligible clinician has never before encountered the patient. The 
numerator would increment upon completion of clinical information 
reconciliation of the electronic summary of care record for 
medications, medication allergies, and current problems. The MIPS 
eligible clinician would no longer be required to manually count each 
individual non-health-IT-related action taken to engage with other 
providers of care and care team members to identify and obtain the 
electronic summary of care record. Instead, the proposed measure would 
focus on the result of these actions when an electronic summary of care 
record is successfully identified, received, and reconciled with the 
patient record. We believe this approach would allow MIPS eligible 
clinicians to determine and implement appropriate workflows supporting 
efforts to receive the electronic summary of care record consistent 
with the implementation of effective health IT information exchange at 
an organizational level.
    Finally, we are proposing to apply our existing policy for cases in 
which the MIPS eligible clinician determines no update or modification 
is necessary within the patient record based on the electronic clinical 
information received, and the MIPS eligible clinician may count the 
reconciliation in the numerator without completing a redundant or 
duplicate update to the record. We welcome public comment on methods by 
which this specific action could potentially be electronically measured 
by the MIPS eligible clinician's health IT system--such as incrementing 
on electronic signature or approval by an authorized health care 
provider--to mitigate the risk of burden associated with manual 
tracking of the action, such as having to click check boxes.
    We welcome public comment on these proposals. We are seeking 
comment on methods and approaches to quantify the reduction in burden 
for MIPS eligible clinicians implementing streamlined workflows for 
this proposed health IT-based measure. We also are seeking comment on 
the impact these

[[Page 35928]]

proposed modifications may have for health IT developers in updating, 
testing, and implementing new measure calculations related to these 
proposed changes. Specifically, we seek comment on whether ONC should 
require developers to recertify their EHR technology as a result of the 
changes proposed, or whether they should be able to make the changes 
and engage in testing without recertification, and on the appropriate 
timeline for such requirements factoring in the proposed continuous 90 
day performance period within the calendar year for clinicians. 
Finally, we are seeking comment on whether this proposed new measure 
that combines the Request/Accept Summary of Care and Clinical 
Information Reconciliation measures should be adopted, or whether 
either or both of the existing Request/Accept Summary of Care and 
Clinical Information Reconciliation measures should be retained in lieu 
of this proposed new measure.
    In the event we finalize the new scoring methodology we are 
proposing in section III.H.3.h.(5)(d) of this proposed rule, an 
exclusion would be available for MIPS eligible clinicians who could not 
implement the Support Electronic Referral Loops by Receiving and 
Incorporating Health Information measure for a performance period in CY 
2019.
    In the event we do not finalize the proposed scoring methodology, 
we would maintain the current Promoting Interoperability performance 
category objectives, measures and reporting requirements as finalized 
in previous rulemaking. MIPS eligible clinicians would be required to 
report the Request/Accept Summary of Care measure as part of the base 
score and the Clinical Information Reconciliation measure would remain 
as part of the performance score as finalized in previous rulemaking 
(82 FR 53674 through 53680).
    We also are proposing that, in order to meet this measure, a MIPS 
eligible clinician must use the capabilities and standards as defined 
for CEHRT at Sec.  170.315(b)(1) and (2).
(iv) Measure Proposals for the Provider to Patient Exchange Objective
    The Provider to Patient Exchange objective for MIPS eligible 
clinicians builds upon the goal of improved access and exchange of 
patient data, patient centered communication and coordination of care 
using CEHRT. We are proposing a new scoring methodology in section 
III.H.3.h.(5)(d) of this proposed rule, under which we are proposing to 
rename the Patient Electronic Access objective to Provider to Patient 
Exchange, remove the Patient-Specific Education measure and rename the 
Provide Patient Access measure to Provide Patients Electronic Access to 
Their Health Information. In addition, we are proposing to remove the 
Coordination of Care through Patient Engagement objective and all 
associated measures. The existing Promoting Interoperability 
performance category Patient Electronic Access objective includes two 
measures and the existing Coordination of Care through Patient 
Engagement objective includes three measures.
    We reviewed the Promoting Interoperability performance category 
requirements and determined that these proposals could reduce program 
complexity and burden and better focus on leveraging the most current 
health IT functions and standards for patient flexibility of access and 
exchange of information.
    We are proposing the Provider to Patient Exchange objective would 
include one measure, the existing Provide Patient Access measure, which 
are proposing to rename to Provide Patients Electronic Access to Their 
Health Information.
    In the event we do not finalize the proposed scoring methodology in 
III.H.3.(5)(c), we would maintain the current Promoting 
Interoperability performance category objectives, measures and 
reporting requirements as finalized in previous rulemaking. MIPS 
eligible clinicians would be required to report the Provide Patient 
Access measure as part of the base score under the Patient Electronic 
Access objective, and the Patient-Specific Education measure would 
remain as part of the performance score as finalized in previous 
rulemaking (82 FR 53674 through 53680). The Coordination of Care 
Through Patient Engagement objective and its associated measures (VDT, 
Secure Messaging, and Patient-Generated Health Data) would remain as 
part of the performance score as finalized in previous rulemaking (82 
FR 53674 through 53680).
(A) Proposed Modification To Provide Patient Access Measure
    We are proposing to change the name of the Provide Patient Access 
measure to Provide Patients Electronic Access to Their Health 
Information measure to better reflect the emphasis on patient 
engagement in their health care and patient's electronic access of 
their health information through use of APIs.
    We propose to change the measure name to emphasize electronic 
access of patient health information as opposed to use of paper based 
actions and limit the focus to only health IT solutions to encourage 
adoption and innovation in use of CEHRT (80 FR 62783 through 62784). In 
addition, we are committed to promoting patient engagement with their 
healthcare information and ensuring access in an electronic format.
(B) Proposed Removal of the Patient-Generated Health Data Measure
    We are proposing to remove the Patient-Generated Health Data (PGHD) 
measure to reduce complexity and focus on the goal of using advanced 
EHR technology and functionalities to advance interoperability and 
health information exchange.
    As finalized in the 2015 EHR Incentive Programs final rule at 80 FR 
62851, the measure is not fully health IT based as we did not specify 
the manner in which health care providers would incorporate the data 
received. Instead, we finalized that health care providers could work 
with their EHR developers to establish the methods and processes that 
work best for their practice and needs. We indicated that this could 
include incorporation of the information using a structured format 
(such as an existing field in the EHR or maintaining an isolation 
between the data and the patient record such as incorporation as an 
attachment, link or text reference which would not require the advanced 
use of CEHRT). While we continue to believe that incorporating this 
data is valuable, we are prioritizing only those actions which are 
completed electronically using certified health IT.
(C) Proposed Removal of the Patient-Specific Education Measure
    We are proposing to remove the Patient-Specific Education measure 
as it has proven burdensome to MIPS eligible clinicians in ways that 
were unintended and detracts from their progress on current program 
priorities.
    The Patient-Specific Education measure was finalized as a 
performance score measure for MIPS eligible clinicians in the CY 2017 
Quality Payment Program final rule with the intent of improving patient 
health, increasing transparency and engaging patients in their care (81 
FR 77228 through 77237).
    We believe that the Patient-Specific Education measure does not 
align with the current emphasis of the Promoting Interoperability 
performance category to increase interoperability, or reduce burden for 
MIPS eligible clinicians. In addition to not including interoperability 
as a core focus, stakeholders have indicated that this measure does not 
capture many of the

[[Page 35929]]

innovative activities around providing patient education, for instance 
new approaches to integrating patient education within clinical 
decision support modules. As a result of this lack of alignment, this 
measure could potentially increase clinician burden.
(D) Proposed Removal of the Secure Messaging Measure
    We are proposing to remove the Secure Messaging measure as it has 
proven burdensome to MIPS eligible clinicians in ways that were 
unintended and detracts from MIPS eligible clinicians' progress on 
current program priorities.
    The Secure Messaging measure was finalized in the CY 2017 Quality 
Payment Program final rule with the intent to build upon the policy 
goals of Stage 2 under the EHR Incentive Programs of using CEHRT for 
health care provider-patient communication (81 FR 77227 through 77236). 
As outlined above, we believe that the Secure Messaging measure does 
not align with the current emphasis of the Promoting Interoperability 
performance category to increase interoperability or reduce burden for 
MIPS eligible clinicians. In addition, we believe there is burden 
associated with tracking secure messages, including the unintended 
consequences of workflows designed for the measure rather than for 
clinical and administrative effectiveness.
(E) Proposed Removal of the View, Download or Transmit Measure
    We are proposing to remove the View, Download or Transmit measure 
as it has proven burdensome to MIPS eligible clinicians in ways that 
were unintended and detracts from their progress on current program 
priorities.
    We received MIPS eligible clinician and stakeholder feedback 
through correspondence, public forums, and listening sessions 
indicating there is ongoing concern with measures which require patient 
action for successful submission. We have noted that data analysis on 
the patient action measures supports stakeholder concerns that barriers 
exist which impact a clinician's ability to meet them. Stakeholders 
have indicated that successful submission of the measure is reliant 
upon the patient, who may face barriers to access which are outside a 
clinician's control.
    After additional review, we note that successful performance 
predicated solely on a patient's action has inadvertently created 
burdens to MIPS eligible clinicians and detracts from progress on 
Promoting Interoperability measure goals of focusing on patient care, 
interoperability and leveraging advanced used of health IT. Therefore, 
we propose to remove the View, Download or Transmit measure.
(v) Proposed Modifications to the Public Health and Clinical Data 
Registry Reporting Objective and Measures
    In connection with the scoring methodology proposed in section 
III.H.3.h.(5)(d) of this proposed rule, we are proposing changes to the 
Public Health and Clinical Data Registry Reporting objective and five 
associated measures.
    We believe that public health reporting through EHRs will extend 
the use of electronic reporting solutions to additional events and care 
processes, increase timeliness and efficiency of reporting and replace 
manual data entry.
    We are proposing to change the name of the objective to Public 
Health and Clinical Data Exchange and are proposing exclusions for each 
of the associated measures.
    Under the new scoring methodology proposed in section 
III.H.3.h.(5)(d) of this proposed rule, we are proposing that a MIPS 
eligible clinician would be required to submit two of the measures of 
the clinician's choice from the five measures associated with the 
objective: Immunization Registry Reporting, Syndromic Surveillance 
Reporting, Electronic Case Reporting, Public Health Registry Reporting, 
and Clinical Data Registry Reporting.
    In prior rulemaking, we recognized the goal of increasing 
interoperability through public health registry exchange of data (80 FR 
62771). We continue to believe that public health reporting is valuable 
in terms of health information exchange between MIPS eligible 
clinicians and public health and clinical data registries. For example, 
when immunization information is directly exchanged between EHRs and 
registries, patient information may be accessed by all of a patient's 
health care providers for improved continuity of care and reduced 
health care provider burden, as well as supporting population health 
monitoring.
    We are also proposing exclusion criteria for each of the Public 
Health and Clinical Data Exchange measures beginning with the 
performance period in 2019. Under the scoring methodology for the 
Promoting Interoperability performance category for the performance 
period in 2018 (82 FR 53676 through 53677), the measures associated 
with the Public Health and Clinical Data Registry Reporting objective 
are not required for the base score, and thus we did not establish 
exclusion criteria for them. However, we understand that some MIPS 
eligible clinicians may not be able to report to public health agencies 
or clinical data registries due to their scope of practice. For 
example, we noted in the CY 2018 Quality Payment Program final rule (82 
FR 53663) that there are MIPS eligible clinicians who lack access to 
immunization registries or do not administer immunizations. Also, we 
noted in the 2017 Quality Payment Program final rule (81 FR 77236) few 
jurisdictions accept syndromic surveillance from non-urgent care EPs. 
Therefore, we are proposing the following measure exclusions based on 
the exclusions finalized in previous rulemaking under the EHR Incentive 
Programs (80 FR 62862 through 62871).
    Measure: Immunization Registry Reporting.
    Proposed Exclusions: Any MIPS eligible clinician meeting one or 
more of the following criteria may be excluded from the Immunization 
Registry Reporting measure if the MIPS eligible clinician:
    1. Does not administer any immunizations to any of the populations 
for which data is collected by its jurisdiction's immunization registry 
or immunization information system during the performance period.
    2. Operates in a jurisdiction for which no immunization registry or 
immunization information system is capable of accepting the specific 
standards required to meet the CEHRT definition at the start of the 
performance period.
    3. Operates in a jurisdiction where no immunization registry or 
immunization information system has declared readiness to receive 
immunization data as of 6 months prior to the start of the performance 
period.
    Measure: Syndromic Surveillance Reporting.
    Proposed Exclusions: Any MIPS eligible clinician meeting one or 
more of the following criteria may be excluded from the Syndromic 
Surveillance Reporting measure if the MIPS eligible clinician:
    1. Is not in a category of health care providers from which 
ambulatory syndromic surveillance data is collected by their 
jurisdiction's syndromic surveillance system.
    2. Operates in a jurisdiction for which no public health agency is 
capable of receiving electronic syndromic surveillance data in the 
specific standards required to meet the CEHRT definition at the start 
of the performance period.
    3. Operates in a jurisdiction where no public health agency has 
declared

[[Page 35930]]

readiness to receive syndromic surveillance data from MIPS eligible 
clinicians as of 6 months prior to the start of the performance period.
    Measure: Electronic Case Reporting.
    Proposed Exclusions: Any MIPS eligible clinician meeting one or 
more of the following criteria may be excluded from the Electronic Case 
Reporting measure if the MIPS eligible clinician:
    1. Does not treat or diagnose any reportable diseases for which 
data is collected by their jurisdiction's reportable disease system 
during the performance period.
    2. Operates in a jurisdiction for which no public health agency is 
capable of receiving electronic case reporting data in the specific 
standards required to meet the CEHRT definition at the start of the 
performance period.
    3. Operates in a jurisdiction where no public health agency has 
declared readiness to receive electronic case reporting data as of 6 
months prior to the start of the performance period.
    Measure: Public Health Registry Reporting.
    Proposed Exclusions: Any MIPS eligible clinician meeting one or 
more of the following criteria may be excluded from the Public Health 
Reporting measure if the MIPS eligible clinician;
    1. Does not diagnose or directly treat any disease or condition 
associated with a public health registry in the MIPS eligible 
clinician's jurisdiction during the performance period.
    2. Operates in a jurisdiction for which no public health agency is 
capable of accepting electronic registry transactions in the specific 
standards required to meet the CEHRT definition at the start of the 
performance period.
    3. Operates in a jurisdiction where no public health registry for 
which the MIPS eligible clinician is eligible has declared readiness to 
receive electronic registry transactions as of 6 months prior to the 
start of the performance period.
    Measure: Clinical Data Registry Reporting.
    Proposed Exclusions: Any MIPS eligible clinician meeting one or 
more of the following criteria may be excluded from the Clinical Data 
Registry Reporting measure if the MIPS eligible clinician;
    1. Does not diagnose or directly treat any disease or condition 
associated with a clinical data registry in their jurisdiction during 
the performance period.
    2. Operates in a jurisdiction for which no clinical data registry 
is capable of accepting electronic registry transactions in the 
specific standards required to meet the CEHRT definition at the start 
of the performance period.
    3. Operates in a jurisdiction where no clinical data registry for 
which the MIPS eligible clinician is eligible has declared readiness to 
receive electronic registry transactions as of 6 months prior to the 
start of the performance period.
    We seek comment on the proposed exclusions and whether there are 
circumstances that would require additional exclusion criteria for the 
measures.
    In addition, we intend to propose in future rulemaking to remove 
the Public Health and Clinical Data Exchange objective and measures no 
later than CY 2022, and are seeking public comment on whether MIPS 
eligible clinicians will continue to share such data with public health 
entities once the Public Health and Clinical Data Exchange objective is 
removed, as well as other policy levers outside of the Promoting 
Interoperability performance category that could be adopted for 
continued reporting to public health and clinical data registries, if 
necessary. As noted above, while we believe that these registries 
provide the necessary monitoring of public health nationally and 
contribute to the overall health of the nation, we are also focusing on 
reducing burden and identifying other appropriate venues in which 
reporting to public health and clinical data registries could be 
reported. We are seeking public comment on the role that each of the 
public health and clinical data registries should have in the future of 
the Promoting Interoperability performance category and whether the 
submission of this data should still be required.
    Lastly, we are seeking public comment on whether the Promoting 
Interoperability performance category is the best means for promoting 
sharing of clinical data with public health entities.
    In the event we do not finalize the new scoring methodology we are 
proposing in section III.H.3.h.(5)(d) of this proposed rule, current 
Promoting Interoperability performance category objectives, measures 
and reporting requirements would be maintained as finalized in previous 
rulemaking. Therefore, all Public Health and Clinical Data Registry 
Reporting measures would be part of the performance and bonus score as 
finalized in previous rulemaking (82 FR 53674 through 53680).
    To assist readers in identifying the requirements of CEHRT for the 
Promoting Interoperability Objectives and Measures under the scoring 
methodology proposed in section III.H.3.h.(5)(d) of this proposed rule, 
we are including Table 40, which includes the 2015 Edition 
certification criteria required to meet the objectives and measures.

    Table 40--Promoting Interoperability Objectives and Measures and
               Certification Criteria for the 2015 Edition
------------------------------------------------------------------------
           Objective                 Measure            2015 Edition
------------------------------------------------------------------------
Protect Patient Health          Security Risk      The requirements are
 Information.                    Analysis.          a part of CEHRT
                                                    specific to each
                                                    certification
                                                    criterion.
e-Prescribing.................  e-Prescribing....  Sec.   170.315(b)(3)
                                                    (Electronic
                                                    Prescribing).
                                                   Sec.   170.315(a)(10)
                                                    (Drug-Formulary and
                                                    Preferred Drug List
                                                    checks).
                                Query of PDMP....  Sec.   170.315(a)(10)
                                                    (Drug-Formulary and
                                                    Preferred Drug List
                                                    checks) and (b)(3)
                                                    (Electronic
                                                    Prescribing).
                                Verify Opioid      Sec.   170.315(a)(10)
                                 Treatment          (Drug-Formulary and
                                 Agreement.         Preferred Drug List
                                                    checks) (b)(3)
                                                    (Electronic
                                                    Prescribing), and
                                                    Sec.   170.205(b)(2)
                                                    (Electronic
                                                    Prescribing
                                                    Standard).
Health Information Exchange...  Support            Sec.   170.315(b)(1)
                                 Electronic         (Transitions of
                                 Referral Loops     Care).
                                 by Sending
                                 Health
                                 Information.
                                Support            Sec.   170.315(b)(1)
                                 Electronic         (Transitions of
                                 Referral Loops     Care).
                                 by Receiving and  Sec.   170.315(b)(2)
                                 Incorporating      (Clinical
                                 Health             Information
                                 Information.       Reconciliation and
                                                    Incorporation).

[[Page 35931]]

 
Provider to Patient Exchange..  Provide Patients   Sec.   170.315(e)(1)
                                 Electronic         (View, Download, and
                                 Access to Their    Transmit to 3rd
                                 Health             Party).
                                 Information.      Sec.   170.315(g)(7)
                                                    (Application Access--
                                                    Patient Selection).
                                                   Sec.   170.315(g)(8)
                                                    (Application Access--
                                                    Data Category
                                                    Request).
                                                   Sec.   170.315(g)(9)
                                                    (Application Access--
                                                    All Data Request).
                                                   The three criteria
                                                    combined are the
                                                    ``API''
                                                    certification
                                                    criteria.
Public Health and Clinical      Immunization       Sec.   170.315(f)(1)
 Data Exchange.                  Registry           (Transmission to
                                 Reporting.         Immunization
                                Syndromic           Registries).
                                 Surveillance      Sec.   170.315(f)(2)
                                 Reporting.         (Transmission to
                                                    Public Health
                                                    Agencies--Syndromic
                                                    Surveillance) Urgent
                                                    Care Setting Only.
                                Electronic Case    Sec.   170.315(f)(5)
                                 Reporting.         (Transmission to
                                                    Public Health
                                                    Agencies--Electronic
                                                    Case Reporting).
                                Public Health      EPs may choose one or
                                 Registry           more of the
                                 Reporting.         following: Sec.
                                                    170.315(f)(4)
                                                    (Transmission to
                                                    Cancer Registries).
                                                   Sec.   170.315(f)(7)
                                                    (Transmission to
                                                    Public Health
                                                    Agencies--Health
                                                    Care Surveys).
                                Clinical Data      No 2015 Edition
                                 Registry           health IT
                                 Reporting.         certification
                                                    criteria at this
                                                    time.
------------------------------------------------------------------------

(vi) Request for Comment--Potential New Measures Health Information 
Exchange Across the Care Continuum
    We are working to introduce additional flexibility to allow MIPS 
eligible clinicians a wider range of options in selecting measures that 
are most appropriate to their setting, patient population, and clinical 
practice improvement goals. For this reason, we are seeking comment on 
a potential concept for future rulemaking to add two additional measure 
options related to health information exchange for MIPS eligible 
clinicians.
    The Promoting Interoperability performance category requirements 
for health information exchange primarily focused on the exchange 
between and among health care providers. While these use cases 
represent a significant portion of the health care industry, the care 
continuum is much broader and includes a wide range of health care 
providers and settings of care that have adopted and implemented health 
IT systems to support patient care and electronic information exchange. 
Specifically, health care providers in long-term care and post-acute 
care settings, skilled nursing facilities, and behavioral health 
settings have made significant advancements in the adoption and use of 
health IT. Many MIPS eligible clinicians are now engaged in bi-
directional exchange of patient health information with these health 
care providers and settings of care and many more are seeking to 
incorporate these workflows as part of efforts to improve care team 
coordination or to support alternative payment models.
    For these reasons, we are seeking comment on two potential new 
measures for inclusion in the program to enable MIPS eligible 
clinicians to exchange health information through health IT supported 
care coordination across a wide range of settings.
    New Measure Description for Support Electronic Referral Loops by 
Sending Health Information Across the Care Continuum: For at least one 
transition of care or referral to a provider of care other than a MIPS 
eligible clinician, the MIPS eligible clinician creates a summary of 
care record using CEHRT; and electronically exchanges the summary of 
care record.
    New Measure Denominator: Number of transitions of care and 
referrals during the performance period for which the MIPS eligible 
clinician was the transitioning or referring health care provider to a 
provider of care other than a MIPS eligible clinician.
    New Measure Numerator: The number of transitions of care and 
referrals in the denominator where a summary of care record was created 
and exchanged electronically using CEHRT.
    New Measure Description for Support Electronic Referral Loops by 
Receiving and Incorporating Health Information Across the Care 
Continuum: For at least one electronic summary of care record received 
by a MIPS eligible clinician from a transition of care or referral from 
a provider of care other than a MIPS eligible clinician, the MIPS 
eligible clinician conducts clinical information reconciliation for 
medications, medication allergies, and problem list.
    New Measure Denominator: The number of electronic summary of care 
records received for a patient encounter during the performance period 
for which a MIPS eligible clinician was the recipient of a transition 
of care or referral from a provider of care other than a MIPS eligible 
clinician.
    New Measure Numerator: The number of electronic summary of care 
records received for which clinical information reconciliation was 
completed using CEHRT for the following three clinical information 
sets: (1) Medication--Review of the patient's medication, including the 
name, dosage, frequency, and route of each medication; (2) Medication 
allergy--Review of the patient's known medication allergies; and (3) 
Current Problem List--Review of the patient's current and active 
diagnoses.
    We are seeking comment on whether these two measures should be 
combined into one measure so that a MIPS eligible clinician who is 
engaged in exchanging health information across the care continuum may 
include any such exchange in a single measure. We seek comment on 
whether the denominators should be combined to a single measure 
including both transitions of care to and from a MIPS eligible 
clinician. We further seek comment on whether the numerators should be 
combined to a single measure including both the sending and receiving 
of electronic patient health information. We are seeking comment on 
whether the potential new measures should be considered for inclusion 
in a future program year or whether stakeholders believe there is 
sufficient readiness and interest in the measures to implement them as 
early as CY 2019.
    For the purposes of focusing the denominator, we are seeking 
comment regarding whether the potential new measures should be limited 
to transitions of care to and/or from referrals involving long-term and 
post-acute care, skilled nursing care, and behavioral health care. We 
also are seeking comment on whether additional settings of care should 
be considered for

[[Page 35932]]

inclusion in the denominators and whether a MIPS eligible clinician 
should be allowed to limit the denominators to a specific type of care 
setting based on their organizational needs, clinical improvement 
goals, or participation in an alternative payment model. We also are 
interested in comments regarding the feasibility of these measures in 
instances where a MIPS eligible clinician receives information from a 
non-MIPS eligible clinician that is not using CEHRT. Finally, we are 
seeking comment on the impact the potential new measures may have for 
health IT developers to develop, test, and implement a new measure 
calculation for a future program year.
(g) Improvement Activities Bonus Score Under the Promoting 
Interoperability Performance Category and Future Reporting 
Considerations
    In the CY 2017 Quality Payment Program final rule (81 FR 77202), we 
discussed our approach to the measurement of the use of CEHRT to allow 
MIPS eligible clinicians and groups the flexibility to implement CEHRT 
in a way that supports their clinical needs. Toward that end, we 
adopted a policy for the 2017 and 2018 performance periods (81 FR 
77202-77209 and 82 FR 53664-53670) and codified it at Sec.  
414.1380(b)(4)(i)(C)(2) to award a bonus score to MIPS eligible 
clinicians who use CEHRT to complete certain activities in the 
improvement activities performance category based on our belief that 
the use of CEHRT in carrying out these activities could further the 
outcomes of clinical practice improvement.
    In section III,H.3.h.(5)(d) of this proposed rule, we have proposed 
significant changes to the scoring methodology and measures beginning 
with the performance period in 2019. In connection with these changes, 
we are not proposing to continue the bonus for completing certain 
improvement activities using CEHRT for the performance period in 2019 
and subsequent performance periods. As discussed in section 
III.H.3.h.(5)(b) of this proposed rule, we are shifting the focus of 
this performance category to put a greater emphasis on interoperability 
and patient access to health information, and we do not believe 
awarding a bonus for performing an improvement activity using CEHRT 
would directly support those goals. While we continue to believe that 
the use of CEHRT in completing improvement activities is extremely 
valuable and vital to the role of CEHRT in practice improvement, we do 
not believe that awarding a bonus in the Promoting Interoperability 
performance category would be appropriate in light of the new direction 
we want to take, and we seek comment on other ways to promote the use 
of CEHRT.
    We invite comments on our decision not to propose to continue the 
bonus for completing certain improvement activities using CEHRT for the 
performance period in 2019 and subsequent performance periods.
    We acknowledge that the omission of this bonus could be viewed as 
increasing burden, and seek to counteract that concern by evaluating 
other methods to reduce burden to offset this potential increase. We 
have also considered various ways to align and streamline the different 
performance categories under the MIPS. In lieu of the improvement 
activities bonus score, we have looked extensively at ways to link 
three of the performance categories--quality, improvement activities 
and Promoting Interoperability--to reduce burden and create a more 
cohesive and closely linked MIPS program. One possibility we have 
identified is to establish several sets of new multi-category measures 
that would cut across the different performance categories and allow 
MIPS eligible clinicians to report once for credit in all three 
performance categories. For example, one possible combined measure 
would bring together the elements of the proposed Promoting 
Interoperability measure, Support Electronic Referral Loops by Sending 
Health Information, the improvement activity, implementation of use of 
specialist reports back to referring clinician or group to close 
referral loop, and the quality measure, Closing the Referral Loop: 
Receipt of Specialist Report. Our goal would be to establish several of 
these combined measures so MIPS eligible clinicians could report once 
for credit across all three performance categories. At the present 
time, we are only seeking comment on this concept, as we are still 
evaluating the appropriate measure combinations and feasibility of a 
multi-category model. We believe that as we further develop the new 
focus and goals of the Promoting Interoperability performance category, 
we may be able to identify additional measure links that could make 
this concept a reality and overcome some of the challenges we currently 
face in implementing this concept. For example, one challenge we have 
identified is the lack of measures and activities that share identical 
and aligned requirements across the three performance categories. We 
seek comment on this reporting model, as well as measure and activity 
suggestions to enhance the link between the three performance 
categories.
    Furthermore, to promote measurement that provides clinicians with 
measures that are meaningful to their practices, we intend to consider 
proposing in future rulemaking MIPS public health priority sets across 
the four performance categories (quality, improvement activities, 
Promoting Interoperability, and cost). We believe that adopting such 
sets would provide clinicians with a cohesive reporting experience, by 
allowing them to focus on activities and measures that fit within their 
workflow, address their patient population needs, and encourage 
increased participation in MIPS. Furthermore, it would drive 
participation and continued improvement across performance categories. 
Consistent with the goals of the Meaningful Measures Initiative, the 
public health priority sets would seek to provide clinicians with sets 
of measures and activities that are most meaningful to them, with an 
emphasis on improving quality of life and outcomes for patients. The 
construction of public health priority sets could also identify where 
there are measurement gaps, and what areas measure development should 
focus on, such as the lack of sufficient measures for certain 
specialists.
    The public health priority sets would be built across performance 
categories and decrease the burden of having to report for separate 
performance categories as relevant measures and activities are bundled. 
In developing the first few public health priority sets, we intend to 
focus on areas that address the opioid epidemic impacting the nation, 
as well as other patient wellness priorities that are attributable to 
more complex diseases or clinical conditions. We intend to develop the 
first few public health priority sets around: Opioids; blood pressure; 
diabetes; and general health (healthy habits). In this proposed rule, 
we are seeking comments on additional public health priority areas that 
should be considered, and whether these public health priority sets 
should be more specialty focused versus condition specific. We are also 
seeking comment on how CMS could implement public health priority sets 
in ways that further minimize burden for health care providers, for 
instance, by offering sets which emphasize use of common health IT 
functionalities. Finally, we are seeking comment on how CMS could 
encourage or incentivize health care providers to consider using these 
public health priority sets.

[[Page 35933]]

(h) Additional Considerations
(i) Nurse Practitioners, Physician Assistants, Clinical Nurse 
Specialists, and Certified Registered Nurse Anesthetists
    In prior rulemaking (82 FR 30079), we discussed our belief that 
certain types of MIPS eligible clinicians (NPs, PAs, CNSs, and CRNAs) 
may lack experience with the adoption and use of CEHRT. Because many of 
these non-physician clinicians were or are not eligible to participate 
in the Medicare or Medicaid Promoting Interoperability Program, we 
stated that we have little evidence as to whether there are sufficient 
measures applicable and available to these types of MIPS eligible 
clinicians under the advancing care information performance category. 
We established a policy for the performance periods in 2017 and 2018 
under section 1848(q)(5)(F) of the Act to assign a weight of zero to 
the advancing care information performance category in the MIPS final 
score if there are not sufficient measures applicable and available to 
NPs, PAs, CRNAs, and CNSs. We will assign a weight of zero only in the 
event that an NP, PA, CRNA, or CNS does not submit any data for any of 
the measures specified for the advancing care information performance 
category, but if they choose to report, they will be scored on the 
advancing care information performance category like all other MIPS 
eligible clinicians and the performance category will be given the 
weighting prescribed by section 1848(q)(5)(E) of the Act. We stated our 
intention to use data from the first performance period (2017) to 
further evaluate the participation of these MIPS eligible clinicians in 
the advancing care information performance category and consider for 
subsequent years whether the measures specified for this category are 
applicable and available to these MIPS eligible clinicians. As we have 
not yet analyzed the data for the first MIPS performance period, it 
would be premature to propose to alter our treatment of these MIPS 
eligible clinicians in year 3.
    We are proposing to continue this policy for the performance period 
in 2019 and to codify the policy at Sec.  414.1380(c)(2)(i)(A)(5). We 
request public comments on this proposal.
(ii) Physical Therapists, Occupational Therapists, Clinical Social 
Workers, and Clinical Psychologists
    As discussed in section III.H.3.a. of this proposed rule, in 
accordance with section 1848(q)(1)(C)(i)(II) of the Act, we are 
proposing to add the following clinician types to the definition of a 
MIPS eligible clinician, beginning with the performance period in 2019: 
Physical therapists, occupational therapists, clinical social workers, 
and clinical psychologists. For the reasons discussed in prior 
rulemaking and in the preceding section III.H.3.h.(5)(f), we are 
proposing to apply the same policy we adopted for NPs, PAs, CNSs, and 
CRNAs for the performance periods in 2017 and 2018 to these new types 
of MIPS eligible clinicians for the performance period in 2019. Because 
many of these clinician types were or are not eligible to participate 
in the Medicare or Medicaid Promoting Interoperability Program, we have 
little evidence as to whether there are sufficient measures applicable 
and available to them under the Promoting Interoperability performance 
category. Thus, we are proposing to rely on section 1848(q)(5)(F) of 
the Act to assign a weight of zero to the Promoting Interoperability 
performance category if there are not sufficient measures applicable 
and available to these new types of MIPS eligible clinicians (physical 
therapists, occupational therapists, clinical social workers, and 
clinical psychologists). We encourage all of these new types of MIPS 
eligible clinicians to report on these measures to the extent they are 
applicable and available; however, we understand that some of them may 
choose to accept a weight of zero for this performance category if they 
are unable to fully report the Promoting Interoperability measures. We 
believe this approach is appropriate for their first performance period 
(in 2019) based on the payment consequences associated with reporting, 
the fact that many of these types of MIPS eligible clinicians may lack 
experience with EHR use, and our current uncertainty as to whether we 
have proposed sufficient measures that are applicable and available to 
these types of MIPS eligible clinicians. We would use their first 
performance period to further evaluate the participation of these MIPS 
eligible clinicians in the Promoting Interoperability performance 
category and would consider for subsequent years whether the measures 
specified for this category are applicable and available to these MIPS 
eligible clinicians.
    These MIPS eligible clinicians may choose to submit Promoting 
Interoperability measures if they determine that these measures are 
applicable and available to them; however, if they choose to report, 
they would be scored on the Promoting Interoperability performance 
category like all other MIPS eligible clinicians and the performance 
category would be given the weighting prescribed by section 
1848(q)(5)(E) of the Act regardless of their Promoting Interoperability 
performance category score.
    We are proposing to codify this policy at Sec.  
414.1380(c)(2)(i)(A)(4).
(6) APM Scoring Standard for MIPS Eligible Clinicians Participating in 
MIPS APMs
(a) Overview
    As codified at Sec.  414.1370, MIPS eligible clinicians, including 
those participating in MIPS APMs, are subject to MIPS reporting 
requirements and payment adjustments, unless excluded on another basis.
    In the CY 2017 Quality Payment Program rule, we finalized the APM 
scoring standard, which is designed to reduce reporting burden for 
participants in certain APMs by reducing the need for duplicative data 
submission to MIPS and their respective APMs, and to avoid potentially 
conflicting incentives between those APMs and the MIPS.
    We established at Sec.  414.1370(c) that the MIPS performance 
period under Sec.  414.1320 applies for the APM scoring standard. We 
finalized under Sec.  414.1370(f) that, under the APM scoring standard, 
MIPS eligible clinicians will be scored at the APM entity group level 
and each MIPS eligible clinician will receive the APM Entity's final 
MIPS score. We propose to amend Sec.  414.1370(f)(2) to state that if 
the APM Entity group is excluded from MIPS, all eligible clinicians 
within that APM Entity group are also excluded from MIPS.
    The MIPS final score under the APM scoring standard is comprised of 
the four MIPS performance categories as finalized at Sec.  414.1370(g): 
Quality; cost; improvement activities; and advancing care information. 
In 2018, these performance categories are scored at 50 percent, 0 
percent, 30 percent, and 20 percent, respectively.
    In this proposed rule for the APM scoring standard, we propose to: 
(1) Revise Sec.  414.1370(b)(3) to clarify the requirement for MIPS 
APMs to assess performance on quality measures and cost/utilization, 
modify the Shared Savings Program quality reporting requirements by 
extending the reporting exception to solo practitioners; (2) remove the 
Promoting Interoperability (formerly advancing care information) full-
TIN reporting requirement for participants in the Shared Savings 
Program to allow individual TIN/NPIs to report for the Promoting 
Interoperability performance category; and (3) update the MIPS APM 
measure

[[Page 35934]]

sets that apply for purposes of the APM scoring standard. In addition, 
we explain how performance feedback may be accessed by ACO participant 
TINs in the Shared Savings Program.
(b) MIPS APM Criteria
    In the CY 2017 Quality Payment Program final rule, we established 
at Sec.  414.1370(b) that for an APM to be considered a MIPS APM, it 
must satisfy the following criteria: (1) APM Entities participate in 
the APM under an agreement with CMS or by law or regulation; (2) the 
APM requires that APM Entities include at least one MIPS eligible 
clinician on a participation list; (3) the APM bases payment incentives 
on performance (either at the APM entity or eligible clinician level) 
on cost/utilization and quality measures; and (4) the APM is neither a 
new APM for which the first performance period begins after the first 
day of the MIPS performance year, nor an APM in the final year of 
operation for which the APM scoring standard is impracticable.
    It has come to our attention that there may be some ambiguity in 
the third criterion at Sec.  414.1370(b)(3). We have received questions 
as to whether the criterion requires MIPS APMs to base payment 
incentives on performance on cost/utilization ``measures,'' or whether 
it requires more generally that MIPS APMs base payment incentives on 
``cost/utilization.'' Because we did not address this exact point in 
prior rulemaking and our intended policy is not strictly clear from the 
regulation text, we are clarifying here that we intended the word 
``measures'' at Sec.  414.1370(b)(3) to modify only ``quality'' and not 
``cost/utilization.'' To make this criterion clearer, we are proposing 
to modify the regulation to specify that a MIPS APM must be designed in 
such a way that participating APM Entities are incented to reduce costs 
of care or utilization of services, or both. This proposed change to 
Sec.  414.1370(b)(3) would make it clear that a MIPS APM could take 
into account performance in terms of cost/utilization using model 
design features other than the direct use of cost/utilization measures. 
Specifically, we are proposing to change the order in which the 
requirements in the third criterion are listed to state that the APM 
bases payment incentives on performance (either at the APM entity or 
eligible clinician level) on quality measures and cost/utilization.
    We further would like to clarify that we will consider each 
distinct track of an APM and whether it meets the above criteria in 
order to be a MIPS APM, and that it is possible for an APM to have 
tracks that are MIPS APMs and tracks that are not MIPS APMs. We would 
not, however, further consider whether the individual APM Entities or 
MIPS eligible clinicians participating within a given track each 
satisfy all of the above MIPS APM criteria.
    For purposes of this proposal, we understand the term ``track'' to 
refer to a distinct arrangement through which an APM Entity 
participates in the APM, and that such participation is mutually 
exclusive of the APM Entity's participation in another ``track'' within 
the same APM. For example, we would consider the two risk arrangements 
under OCM to be two separate ``tracks.''
    We also would like to clarify our interpretation of the rule at 
Sec.  414.1370(b)(4)(i) for APMs that begin after the first day of the 
MIPS performance period for the year (currently January 1), but require 
participants to report quality data for quality measures tied to 
payment for the full MIPS performance period, beginning January 1. 
Under these circumstances where quality measures tied to payment must 
be reported for purposes of the APM from the first day of the MIPS 
performance period, we believe it would be counter to the purpose of 
the APM scoring standard to require duplicative reporting of quality 
measures for both the APM and MIPS, and to create potentially 
conflicting incentives between the quality scoring requirements and 
payment incentive structures under the APM and MIPS. Therefore, for the 
purposes of MIPS APM determinations, we consider the first performance 
year for an APM to begin as of the first date for which eligible 
clinicians and APM entities participating in the model must report on 
quality measures under the terms of the APM.
    Based on the MIPS APM criteria, for the 2019 MIPS performance year, 
we expect that ten APMs likely will satisfy the requirements to be MIPS 
APMs: Comprehensive ESRD Care Model (all Tracks), Comprehensive Primary 
Care Plus Model (all Tracks), Next Generation ACO Model, Oncology Care 
Model (all Tracks), Medicare Shared Savings Program (all Tracks), 
Medicare ACO Track 1+ Model, Bundled Payments for Care Improvement, 
Advanced, Independence at Home Demonstration (if extended), Maryland 
Total Cost of Care Model (Maryland Primary Care Program), and Vermont 
Medicare ACO Initiative.
(c) Calculating MIPS APM Performance Category Scores
(i) Quality Performance Category
    For the quality performance category, MIPS eligible clinicians in 
APM Entities will continue to be scored only on the quality measures 
that are required under the terms of their respective APMs, and 
available for scoring as specified in Sec.  414.1370(g)(1) and 
explained in the CY 2017 Quality Payment Program final rule (82 FR 
53698, 53692).
(A) Web Interface Reporters
    In the CY 2018 Quality Payment Program final, we discussed, the 
requirements for MIPS eligible clinicians participating in a MIPS APM 
that requires use of the CMS Web Interface for quality reporting, 
subsequently referred to as ``Web Interface Reporters'' (82 FR 53954). 
In that rule we finalized a policy to use quality measure data that 
participating APM Entities submit using the CMS Web Interface and CAHPS 
surveys as required under the terms of the APM, and to use MIPS 
benchmarks for these measures when APM benchmarks are not available, in 
order to score quality for MIPS eligible clinicians at the APM Entity 
level under the APM scoring standard (82 FR 53568, 53692). We also 
codified at Sec.  414.1370(f)(1) a policy under which, in the event a 
Shared Savings Program ACO does not report quality measures as required 
by the Shared Savings Program under Sec.  425.508, each ACO participant 
TIN will be treated as a unique APM entity for purposes of the APM 
scoring standard, and may report data for the MIPS quality performance 
category according to the MIPS submission and reporting requirements.
    For the 2019 MIPS performance year, we anticipate that there will 
be four Web Interface Reporter APMs: The Shared Savings Program; the 
Track 1+ Model; Next Generation ACO Model; and the Vermont ACO Medicare 
Initiative.
(aa) Complete Reporting Requirement
    Under Sec.  414.1370(f)(1), if a Shared Savings Program ACO does 
not report data on quality measures as required by the Shared Savings 
Program under Sec.  425.508, each ACO participant TIN will be treated 
as a unique APM Entity for purposes of the APM scoring standard and the 
ACO participant TINs may report data for the MIPS quality performance 
category according to the MIPS submission and reporting requirements. 
We would like to clarify that any ``partial'' reporting through the CMS 
Web Interface that does not satisfy

[[Page 35935]]

the requirements of the Shared Savings Program will be considered a 
failure to report. Should a Shared Savings Program ACO fail to report, 
the exception under Sec.  414.1370(f)(1) is triggered. In this 
scenario, each ACO participant TIN has the opportunity to report 
quality data to MIPS according to MIPS group reporting requirements in 
order to avoid a score of zero for the quality performance category (81 
FR 77256).
    We recognize that, under this policy, successfully reporting to 
MIPS according to group reporting requirements may be difficult for 
solo practitioners, for whom case thresholds and other requirements may 
make many group reporting measures unavailable. Therefore, we are 
modifying the exception such that beginning in 2019, in the case of a 
Shared Savings Program ACO's failure to report quality measures as 
required by the Shared Saving Program we would also allow a solo 
practitioner (a MIPS eligible clinician who has only one NPI billing 
through their TIN), to report on any available MIPS measures, including 
individual measures, in the event that their ACO fails to complete 
reporting for all Web Interface measures.
    We are also proposing that, beginning with the 2019 performance 
period, the complete reporting requirement for Web Interface reporters 
be modified to specify that if an APM Entity (in this case, an ACO) 
fails to complete reporting for Web Interface measures but successfully 
reports the CAHPS for ACOs survey, we will score the CAHPS for ACOs 
survey and apply it towards the APM Entity's quality performance 
category score. In this scenario the Shared Savings Program TIN-level 
reporting exception would not be triggered and all MIPS eligible 
clinicians within the ACO would receive the APM Entity score.
    We seek comment on this proposal.
(B) Other MIPS APMs
    Under Sec.  414.1370(g)(1)(ii), the MIPS quality performance 
category score for a MIPS performance period is calculated for the APM 
Entity using the data submitted by the APM Entity based on measures 
specified by us through notice and comment rulemaking and available for 
scoring for each Other MIPS APM from among those used under the terms 
of the Other MIPS APM.
    In the 2019 MIPS performance year, we anticipate that there will be 
up to six Other MIPS APMs for which we will use this scoring 
methodology, based on their respective measure sets and reporting 
requirements: The Oncology Care Model; Comprehensive ESRD Care Model; 
Comprehensive Primary Care Plus Model; the Bundled Payments for Care 
Improvement Advanced; Maryland Primary Care Program; and Independence 
at Home Demonstration (in the event of an extension).
(ii) Promoting Interoperability Performance Category
    In the CY 2017 Quality Payment Program final rule (81 FR 77262 
through 77264; 81 FR 77266 through 77269), we established a policy at 
Sec.  414.1370(g)(4)(ii) for MIPS APMs other than the Shared Savings 
Program, under which we attribute one Promoting Interoperability 
performance category score to each MIPS eligible clinician in an APM 
Entity group based on either individual or group-level data submitted 
for the MIPS eligible clinician and using the highest available score. 
We will then use these scores to create an APM Entity group score equal 
to the average of the highest scores available for each MIPS eligible 
clinician in the APM Entity group.
    For the Shared Savings Program, we also finalized at Sec.  
414.1370(g)(4)(i) that ACO participant TINs are required to report on 
the Promoting Interoperability performance category, and we will weight 
and aggregate the ACO participant TIN scores to determine an APM Entity 
group score (81 FR 77258 through 77260). This policy was meant to align 
requirements between the MIPS Promoting Interoperability measures and 
the Shared Savings Program ACO-11 measure, which is used to assess 
Shared Savings Program ACOs based on the MIPS Promoting 
Interoperability measures. However, we have found that limiting 
reporting to the ACO participant TIN creates unnecessary confusion, and 
restricts Promoting Interoperability reporting options for MIPS 
eligible clinicians who participate in the Shared Savings Program. 
Therefore, beginning in the 2019 MIPS performance period, we are 
proposing to no longer apply the requirement as finalized at Sec.  
414.1370(g)(4)(i) and instead to apply the existing policy at Sec.  
414.1370(g)(4)(ii) to MIPS eligible clinicians who participate in the 
Shared Savings Program so that they may report on the Promoting 
Interoperability performance category at either the individual or group 
level like all other MIPS eligible clinicians under the APM scoring 
standard.
    We seek comment on this proposal.
(d) MIPS APM Performance Feedback
    As we discussed in the CY 2017 and 2018 Quality Payment Program 
final rules (81 FR 77270, and 82 FR 53704 through 53705, respectively), 
MIPS eligible clinicians who are scored under the APM scoring standard 
will receive performance feedback under section 1848(q)(12) of the Act.
    Regarding access to performance feedback, we should note that 
whereas split-TIN APM Entities and their participants can only access 
their performance feedback at the APM Entity or individual MIPS 
eligible clinician level, MIPS eligible clinicians participating in the 
Shared Savings Program, which only includes full-TIN ACOs, will be able 
to access their performance feedback at the ACO participant TIN level.
(e) Measure Sets

                            Table 41--MIPS APM Measure List--Comprehensive ESRD Care
----------------------------------------------------------------------------------------------------------------
                                  NQF/Quality  ID    National quality                           Primary measure
          Measure name                  No.          strategy domain     Measure description        steward
----------------------------------------------------------------------------------------------------------------
Diabetes Care: Eye Exam........  0055.............  Effective          Percentage of patients  NCQA.
                                                     Clinical Care.     18-75 years of age
                                                                        with diabetes who had
                                                                        a retinal or dilated
                                                                        eye exam by an eye
                                                                        care professional
                                                                        during the
                                                                        measurement period or
                                                                        a negative retinal
                                                                        exam (no evidence of
                                                                        retinopathy) in the
                                                                        12 months prior to
                                                                        the measurement
                                                                        period.

[[Page 35936]]

 
Diabetes Care: Foot Exam.......  0056.............  Effective          Percentage of patients  NCQA.
                                                     Clinical Care.     18-75 years of age
                                                                        with diabetes (type 1
                                                                        and type 2) who
                                                                        received a foot exam
                                                                        (visual inspection
                                                                        and sensory exam with
                                                                        mono filament and a
                                                                        pulse exam) during
                                                                        the previous
                                                                        measurement year.
Advance Care Plan..............  0326.............  Communication and  Percentage of patients  NCQA.
                                                     Care               aged 65 years and
                                                     Coordination.      older who have an
                                                                        advance care plan or
                                                                        surrogate decision
                                                                        maker documented in
                                                                        the medical record or
                                                                        documentation in the
                                                                        medical record that
                                                                        an advance care plan
                                                                        was discussed but the
                                                                        patient did not wish
                                                                        or was not able to
                                                                        name a surrogate
                                                                        decision maker or
                                                                        provide an advance
                                                                        care plan.
Medication Reconciliation Post-  0554.............  Communication and  The percentage of       NCQA.
 Discharge.                                          Care               discharges from any
                                                     Coordination.      inpatient facility
                                                                        (e.g., hospital,
                                                                        skilled nursing
                                                                        facility, or
                                                                        rehabilitation
                                                                        facility) for
                                                                        patients 18 years of
                                                                        age and older seen
                                                                        within 30 days
                                                                        following the
                                                                        discharge in the
                                                                        office by the
                                                                        physicians,
                                                                        prescribing
                                                                        practitioner,
                                                                        registered nurse, or
                                                                        clinical pharmacist
                                                                        providing on-going
                                                                        care for whom the
                                                                        discharge medication
                                                                        list was reconciled
                                                                        with the current
                                                                        medication list in
                                                                        the outpatient
                                                                        medical record.
                                                                        National Committee
                                                                        for Quality
                                                                        Assurance. This
                                                                        measure is reported
                                                                        as three rates
                                                                        stratified by age
                                                                        group:
                                                                        Reporting
                                                                        Criteria 1: 18-64
                                                                        years of age.
                                                                        Reporting
                                                                        Criteria 2: 65 years
                                                                        and older.
                                                                        Total Rate:
                                                                        All patients 18 years
                                                                        of age and Older.
Influenza Immunization for the   Not Endorsed.....  N/A..............  Percentage of patients  KCQA.
 ESRD Population.                                                       aged 6 months and
                                                                        older seen for a
                                                                        visit between July 1
                                                                        and March 31 who
                                                                        received an influenza
                                                                        immunization OR who
                                                                        reported previous
                                                                        receipt of an
                                                                        influenza
                                                                        immunization.
Pneumococcal Vaccination Status  0043.............  Community/         Percentage of patients  NCQA.
                                                     Population         65 years of age and
                                                     Health.            older who have ever
                                                                        received a
                                                                        pneumococcal vaccine.
Screening for Clinical           0418.............  Community/         Percentage of patients  CMS.
 Depression and Follow-Up Plan.                      Population         aged 12 and older
                                                     Health.            screened for
                                                                        depression on the
                                                                        date of the encounter
                                                                        and using an age
                                                                        appropriate
                                                                        standardized
                                                                        depression screening
                                                                        tool AND if positive,
                                                                        a follow-up plan is
                                                                        documented on the
                                                                        date of the positive
                                                                        screen.
Tobacco Use: Screening and       0028.............  Community/         Percentage of patients  PCPI Foundation.
 Cessation Intervention.                             Population         aged 18 years and
                                                     Health.            older who were
                                                                        screened for tobacco
                                                                        use one or more times
                                                                        within 24 months AND
                                                                        who received
                                                                        cessation counseling
                                                                        intervention if
                                                                        identified as a
                                                                        tobacco user.
Falls: Screening, Risk           0101.............  Patient Safety...  (A) Screening for       NCQA.
 Assessment, and Plan of Care                                           Future Fall Risk:
 to Prevent Future Falls.                                               Patients who were
                                                                        screened for future
                                                                        fall risk at last
                                                                        once within 12
                                                                        months. (B)
                                                                        Multifactorial Falls
                                                                        Risk Assessment:
                                                                        Patients at risk of
                                                                        future fall who had a
                                                                        multifactorial risk
                                                                        assessment for falls
                                                                        completed within 12
                                                                        months. (C) Plan of
                                                                        Care to Prevent
                                                                        Future Falls:
                                                                        Patients at risk of
                                                                        future fall with a
                                                                        plan of care or falls
                                                                        prevention documented
                                                                        within 12 months.
ICH CAHPS: Nephrologists'        0258.............  N/A..............  Summary/Survey          CMS.
 Communication and Caring.                                              Measures may include:
                                                                        Getting
                                                                        timely care,
                                                                        appointments, and
                                                                        information..
                                                                        How well
                                                                        providers
                                                                        communicate..
                                                                        Patients'
                                                                        rating of provider..
                                                                        Access to
                                                                        specialists.
                                                                        Health
                                                                        promotion and
                                                                        education.
                                                                        Shared
                                                                        Decision-making.

[[Page 35937]]

 
                                                                        Health status
                                                                        and functional
                                                                        status.
                                                                        Courteous and
                                                                        helpful office staff.
                                                                        Care
                                                                        coordination.
                                                                        Between visit
                                                                        communication.
                                                                        Helping you
                                                                        to take medications
                                                                        as directed, and
                                                                        Stewardship
                                                                        of patient resources.
ICH CAHPS: Quality of Dialysis   0258.............  N/A..............  Comparison of services  CMS.
 Center Care and Operations.                                            and quality of care
                                                                        that dialysis
                                                                        facilities provide
                                                                        from the perspective
                                                                        of ESRD patients
                                                                        receiving in-center
                                                                        hemodialysis care.
                                                                        Patients will assess
                                                                        their dialysis
                                                                        providers, including
                                                                        nephrologists and
                                                                        medical and non-
                                                                        medical staff, the
                                                                        quality of dialysis
                                                                        care they receive,
                                                                        and information
                                                                        sharing about their
                                                                        disease.
ICH CAHPS: Providing             0258.............  N/A..............  Comparison of services  CMS.
 Information to Patients.                                               and quality of care
                                                                        that dialysis
                                                                        facilities provide
                                                                        from the perspective
                                                                        of ESRD patients
                                                                        receiving in-center
                                                                        hemodialysis care.
                                                                        Patients will assess
                                                                        their dialysis
                                                                        providers, including
                                                                        nephrologists and
                                                                        medical and non-
                                                                        medical staff, the
                                                                        quality of dialysis
                                                                        care they receive,
                                                                        and information
                                                                        sharing about their
                                                                        disease.
ICH CAHPS: Rating of the         0258.............  N/A..............  Comparison of services  CMS.
 Nephrologist.                                                          and quality of care
                                                                        that dialysis
                                                                        facilities provide
                                                                        from the perspective
                                                                        of ESRD patients
                                                                        receiving in-center
                                                                        hemodialysis care.
                                                                        Patients will assess
                                                                        their dialysis
                                                                        providers, including
                                                                        nephrologists and
                                                                        medical and non-
                                                                        medical staff, the
                                                                        quality of dialysis
                                                                        care they receive,
                                                                        and information
                                                                        sharing about their
                                                                        disease.
ICH CAHPS: Rating of Dialysis    0258.............  N/A..............  Comparison of services  CMS.
 Center Staff.                                                          and quality of care
                                                                        that dialysis
                                                                        facilities provide
                                                                        from the perspective
                                                                        of ESRD patients
                                                                        receiving in-center
                                                                        hemodialysis care.
                                                                        Patients will assess
                                                                        their dialysis
                                                                        providers, including
                                                                        nephrologists and
                                                                        medical and non-
                                                                        medical staff, the
                                                                        quality of dialysis
                                                                        care they receive,
                                                                        and information
                                                                        sharing about their
                                                                        disease.
ICH CAHPS: Rating of the         0258.............  N/A..............  Comparison of services  CMS.
 Dialysis Facility.                                                     and quality of care
                                                                        that dialysis
                                                                        facilities provide
                                                                        from the perspective
                                                                        of ESRD patients
                                                                        receiving in-center
                                                                        hemodialysis care.
                                                                        Patients will assess
                                                                        their dialysis
                                                                        providers, including
                                                                        nephrologists and
                                                                        medical and non-
                                                                        medical staff, the
                                                                        quality of dialysis
                                                                        care they receive,
                                                                        and information
                                                                        sharing about their
                                                                        disease.
Standardized Mortality Ratio...  0369.............  N/A..............  This measure is         CMS.
                                                                        calculated as a ratio
                                                                        but expressed as a
                                                                        rate.
Standardized First Kidney        Not Endorsed.....  N/A..............  The standardized ratio  CMS.
 Transplant Waitlist Ratio for                                          of the observed to
 Incident Dialysis Patients                                             expected number of
 (SWR).                                                                 incident patients
                                                                        under age 75 listed
                                                                        on the kidney or
                                                                        kidney-pancreas
                                                                        transplant waitlist
                                                                        or who received a
                                                                        living donor
                                                                        transplant within the
                                                                        first year of
                                                                        initiating dialysis
                                                                        based on the national
                                                                        rate.
Percentage of Prevalent          Not Endorsed.....  N/A..............  The percentage of       CMS.
 Patients Waitlisted (PPPW).                                            patients who were on
                                                                        the kidney or kidney-
                                                                        pancreas transplant
                                                                        waitlist.
----------------------------------------------------------------------------------------------------------------


[[Page 35938]]


                  Table 42--MIPS APM Measure List--Comprehensive Primary Care Plus (CPC+) Model
----------------------------------------------------------------------------------------------------------------
                                  NQF/Quality  ID    National quality                           Primary measures
          Measure name                  No.          strategy domain     Measure description        steward
----------------------------------------------------------------------------------------------------------------
Controlling High Blood Pressure  0018.............  Effective          Percentage of patients  National
                                                     Treatment/         18-85 years of age      Committee for
                                                     Clinical Care.     who had a diagnosis     Quality
                                                                        of hypertension and     Assurance.
                                                                        whose blood pressure
                                                                        was adequately
                                                                        controlled (<140/90
                                                                        mmHg) during the
                                                                        measurement period.
Diabetes: Hemoglobin A1c         0059.............  Effective          Percentage of patients  National
 (HbA1c) Poor Control (>9%).                         Treatment/         18-75 years of age      Committee for
                                                     Clinical Care.     with diabetes who had   Quality
                                                                        hemoglobin A1c >9.0%    Assurance.
                                                                        during the
                                                                        measurement period.
Dementia: Cognitive Assessment.  2872.............  Effective          Percentage of           PCPI Foundation.
                                                     Treatment/         patients, regardless
                                                     Clinical Care.     of age, with a
                                                                        diagnosis of dementia
                                                                        for whom an
                                                                        assessment of
                                                                        cognition is
                                                                        performed and the
                                                                        results reviewed at
                                                                        least once within a
                                                                        12-month period.
Falls: Screening for Future      0101.............  Patient Safety...  Percentage of patients  National
 Fall Risk.                                                             65 years of age and     Committee for
                                                                        older who were          Quality
                                                                        screened for future     Assurance.
                                                                        fall risk during the
                                                                        measurement period.
Initiation and Engagement of     0004.............  Effective          Percentage of patients  National
 Alcohol and Other Drug                              Treatment/         13 years of age and     Committee for
 Dependence Treatment.                               Clinical Care.     older with a new        Quality
                                                                        episode of alcohol      Assurance.
                                                                        and other drug (AOD)
                                                                        dependence who
                                                                        received the
                                                                        following. Two rates
                                                                        are reported.
                                                                       a. Percentage of
                                                                        patients who
                                                                        initiated treatment
                                                                        within 14 days of the
                                                                        diagnosis..
                                                                       b. Percentage of
                                                                        patients who
                                                                        initiated treatment
                                                                        and who had two or
                                                                        more additional
                                                                        services with an AOD
                                                                        diagnosis within 30
                                                                        days of the
                                                                        initiation visit.
Closing the Referral Loop:       Not Endorsed.....  Communication and  Percentage of patients  CMS.
 Receipt of Specialist Report.                       Care               with referrals,
                                                     Coordination.      regardless of age,
                                                                        for which the
                                                                        referring provider
                                                                        receives a report
                                                                        from the provider to
                                                                        whom the patient was
                                                                        referred.
Cervical Cancer Screening......  0032.............  Effective          Percentage of women 21- National
                                                     Treatment/         64 years of age, who    Committee for
                                                     Clinical Care.     were screened for       Quality
                                                                        cervical cancer using   Assurance.
                                                                        either of the
                                                                        following criteria.
                                                                        Women age 21-
                                                                        64 who had cervical
                                                                        cytology performed
                                                                        every 3 years..
                                                                        Women age 30-
                                                                        64 who had cervical
                                                                        cytology/human
                                                                        papillomavirus (HPV)
                                                                        co-testing performed
                                                                        every 5 years.
Colorectal Cancer Screening....  0034.............  Effective          Percentage of           National
                                                     Treatment/         patients, 50-75 years   Committee for
                                                     Clinical Care.     of age who had          Quality
                                                                        appropriate screening   Assurance.
                                                                        for colorectal cancer.
Diabetes: Eye Exam.............  0055.............  Effective          Percentage of patients  National
                                                     Treatment/         18-75 years of age      Committee for
                                                     Clinical Care.     with diabetes who had   Quality
                                                                        a retinal or dilated    Assurance.
                                                                        eye exam by an eye
                                                                        care professional
                                                                        during the
                                                                        measurement period or
                                                                        a negative retinal
                                                                        exam (no evidence of
                                                                        retinopathy) in the
                                                                        12 months prior to
                                                                        the measurement
                                                                        period.
Preventive Care and Screening:   0028.............  Community/         Percentage of patients  PCPI Foundation.
 Tobacco Use: Screening and                          Population         aged 18 years and
 Cessation Intervention.                             Health.            older who were
                                                                        screened for tobacco
                                                                        use one or more times
                                                                        within 24 months and
                                                                        who received
                                                                        cessation counseling
                                                                        intervention if
                                                                        identified as a
                                                                        tobacco user.
Breast Cancer Screening........  2372.............  Effective          Percentage of women 50- National
                                                     Treatment/         74 years of age who     Committee for
                                                     Clinical Care.     had a mammogram to      Quality
                                                                        screen for breast       Assurance.
                                                                        cancer.
CG-CAPHS Survey 3.0--modified    Not Endorsed.....  Person and         CG-CAHPS Survey 3.0...  AHRQ.
 for CPC+.                                           Caregiver-
                                                     Centered
                                                     Experience and
                                                     Outcomes.
Inpatient Hospital Utilization.  Not Endorsed.....  Communication and  For members 18 years    National
                                                     Care               of age and older, the   Committee for
                                                     Coordination.      risk-adjusted ratio     Quality
                                                                        of observed to          Assurance.
                                                                        expected acute
                                                                        inpatient discharges
                                                                        during the
                                                                        measurement year
                                                                        reported by Surgery,
                                                                        Medicine, and Total.
Emergency Department             Not Endorsed.....  Communication and  For members 18 years    National
 Utilization.                                        Care               of age and older, the   Committee for
                                                     Coordination.      risk-adjusted ratio     Quality
                                                                        of observed to          Assurance.
                                                                        expected emergency
                                                                        department (ED)
                                                                        visits during the
                                                                        measurement year.

[[Page 35939]]

 
Diabetes: Medical Attention for  0062.............  Effective          The percentage of       National
 Nephropathy.                                        Treatment/         patients 18-75 years    Committee for
                                                     Clinical Care.     of age with diabetes    Quality
                                                                        who had a nephropathy   Assurance.
                                                                        screening test or
                                                                        evidence of
                                                                        nephropathy during
                                                                        the measurement
                                                                        period.
Preventive Care and Screening:   0418.............  Community/         Percentage of patients  PCPI Foundation.
 Depression and Follow-Up Plan.                      Population         aged 12 years and
                                                     Health.            older screened for
                                                                        depression on the
                                                                        date of the encounter
                                                                        using an age
                                                                        appropriate
                                                                        standardized
                                                                        depression screening
                                                                        tool AND if positive,
                                                                        a follow-up plan is
                                                                        documented on the
                                                                        date of the positive
                                                                        screen.
Depression Utilization of the    0712.............  Effective          The percentage of       MN Community
 PHQ-9 Tool.                                         Treatment/         patients age 18 and     Measurement.
                                                     Clinical Care.     older with the
                                                                        diagnosis of major
                                                                        depression or
                                                                        dysthymia who have a
                                                                        completed PHQ-9
                                                                        during each
                                                                        applicable 4 month
                                                                        period in which there
                                                                        was a qualifying
                                                                        visit.
Preventive Care and Screening:   0041.............  Community/         Percentage of patients  American Medical
 Influenza Immunization.                             Population         aged 6 months and       Association-
                                                     Health.            older seen for a        convened
                                                                        visit between October   Physician
                                                                        1 and March 31 who      Consortium for
                                                                        received an influenza   Performance
                                                                        immunization OR who     Improvement(R)
                                                                        reported previous       (AMA-PCPI).
                                                                        receipt of an
                                                                        influenza
                                                                        immunization.
Pneumococcal Vaccination Status  Not Endorsed.....  Community/         Percentage of patients  National
 for Older Adults.                                   Population         65 years of age and     Committee for
                                                     Health.            older who have ever     Quality
                                                                        received a              Assurance.
                                                                        pneumococcal vaccine.
Ischemic Vascular Disease        0068.............  Effective          Percentage of patients  National
 (IVD): Use of Aspirin or                            Treatment/         18 years of age and     Committee for
 Another Antiplatelet.                               Clinical Care.     older who were          Quality
                                                                        diagnosed with acute    Assurance.
                                                                        myocardial infarction
                                                                        (AMI), coronary
                                                                        artery bypass graft
                                                                        (CABG) or
                                                                        percutaneous coronary
                                                                        interventions (PCI)
                                                                        in the 12 months
                                                                        prior to the
                                                                        measurement period,
                                                                        or who had an active
                                                                        diagnosis of ischemic
                                                                        vascular disease
                                                                        (IVD) during the
                                                                        measurement period,
                                                                        and who had
                                                                        documentation of use
                                                                        of aspirin or another
                                                                        antiplatelet during
                                                                        the measurement
                                                                        period.
Statin Therapy for the           Not Endorsed.....  Effective          Percentage of the       CMS.
 Prevention and Treatment of                         Treatment/         following patients--
 Cardiovascular Disease.                             Clinical Care.     all considered at
                                                                        high risk of
                                                                        cardiovascular
                                                                        events--who were
                                                                        prescribed or were on
                                                                        statin therapy during
                                                                        the measurement
                                                                        period:
                                                                        Adults aged
                                                                        >=21 years who were
                                                                        previously diagnosed
                                                                        with or currently
                                                                        have an active
                                                                        diagnosis of clinical
                                                                        atherosclerotic
                                                                        cardiovascular
                                                                        disease (ASCVD); OR.
                                                                        Adults aged
                                                                        >=21 years who have
                                                                        ever had a fasting or
                                                                        direct low-density
                                                                        lipoprotein
                                                                        cholesterol (LDL-C)
                                                                        level >=190 mg/dL or
                                                                        were previously
                                                                        diagnosed with or
                                                                        currently have an
                                                                        active diagnosis of
                                                                        familial or pure
                                                                        hypercholesterolemia;
                                                                        OR
                                                                        Adults aged
                                                                        40-75 years with a
                                                                        diagnosis of diabetes
                                                                        with a fasting or
                                                                        direct LDL-C level of
                                                                        70-189 mg/dL.
Use of High-Risk Medications in  0022.............  Patient Safety...  Percentage of patients  National
 the Elderly.                                                           65 years of age and     Committee for
                                                                        older who were          Quality
                                                                        ordered high-risk       Assurance.
                                                                        medications.
Preventive Care and Screening:   Not Endorsed.....  Community/         Percentage of patients  CMS.
 Screening for High Blood                            Population         aged 18 years and
 Pressure and Follow-Up                              Health.            older seen during the
 Documented.                                                            reporting period who
                                                                        were screened for
                                                                        high blood pressure
                                                                        AND a recommended
                                                                        follow-up plan is
                                                                        documented based on
                                                                        the current blood
                                                                        pressure (BP) reading
                                                                        as indicated.
Documentation of Current         0419.............  Patient Safety...  Percentage of visits    CMS.
 Medications in the Medical                                             for patients aged 18
 Record.                                                                years and older for
                                                                        which the eligible
                                                                        professional attests
                                                                        to documenting a list
                                                                        of current
                                                                        medications using all
                                                                        immediate resources
                                                                        available on the date
                                                                        of the encounter.

[[Page 35940]]

 
Preventive Care and Screening:   0421.............  Community/         Percentage of patients  CMS.
 Body Mass Index (BMI)                               Population         aged 18 years and
 Screening and Follow-Up Plan.                       Health.            older with a BMI
                                                                        documented during the
                                                                        current encounter or
                                                                        during the previous
                                                                        twelve months AND
                                                                        with a BMI outside of
                                                                        normal parameters, a
                                                                        follow-up plan is
                                                                        documented during the
                                                                        encounter or during
                                                                        the previous twelve
                                                                        months of the current
                                                                        encounter.
Diabetes: Foot Exam............  0056.............  Effective          Percentage of patients  National
                                                     Treatment/         18-75 years of age      Committee for
                                                     Clinical Care.     with diabetes (type 1   Quality
                                                                        and type 2) who         Assurance.
                                                                        received a foot exam
                                                                        (visual inspection
                                                                        and sensory exam with
                                                                        mono filament and a
                                                                        pulse exam) during
                                                                        the previous
                                                                        measurement year.
Heart Failure (HF): Angiotensin- 0081.............  Effective          Percentage of patients  PCPI Foundation.
 Converting Enzyme (ACE)                             Treatment/         aged 18 years and
 Inhibitor or Angiotensin                            Clinical Care.     older with a
 Receptor Blocker (ARB) Therapy                                         diagnosis of heart
 for Left Ventricular Systolic                                          failure (HF) with a
 Dysfunction (LVSD).                                                    current or prior left
                                                                        ventricular ejection
                                                                        fraction (LVEF) <40%
                                                                        who were prescribed
                                                                        ACE inhibitor or ARB
                                                                        therapy either within
                                                                        a 12 month period
                                                                        when seen in the
                                                                        outpatient setting OR
                                                                        at each hospital
                                                                        discharge.
Heart Failure (HF): Beta-        0083.............  Effective          Percentage of patients  PCPI Foundation.
 Blocker Therapy for Left                            Treatment/         aged 18 years and
 Ventricular Systolic                                Clinical Care.     older with a
 Dysfunction (LVSD).                                                    diagnosis of heart
                                                                        failure (HF) with a
                                                                        current or prior left
                                                                        ventricular ejection
                                                                        fraction (LVEF) <40%
                                                                        who were prescribed
                                                                        beta-blocker therapy
                                                                        either within a 12
                                                                        month period when
                                                                        seen in the
                                                                        outpatient setting OR
                                                                        at each hospital
                                                                        discharge.
Coronary Artery Disease (CAD):   0070.............  Effective          Percentage of patients  PCPI Foundation.
 Beta-Blocker Therapy-Prior                          Treatment/         aged 18 years and
 Myocardial Infarction (MI) or                       Clinical Care.     older with a
 Left Ventricular Systolic                                              diagnosis of coronary
 Dysfunction (LVEF <40%).                                               artery disease seen
                                                                        within a 12 month
                                                                        period who also have
                                                                        a prior MI or a
                                                                        current or prior LVEF
                                                                        <40% who were
                                                                        prescribed beta-
                                                                        blocker therapy.
Appropriate Use of DXA Scans in  Not Endorsed.....  Effective          Percentage of female    CMS.
 Women Under 65 Years Who Do                         Treatment/         patients aged 50 to
 Not Meet the Risk Factor                            Clinical Care.     64 without select
 Profile for Osteoporotic                                               risk factors for
 Fracture.                                                              osteoporotic fracture
                                                                        who received an order
                                                                        for a dual-energy x-
                                                                        ray absorptiometry
                                                                        (DXA) scan during the
                                                                        measurement period.
HIV Screening..................  Not Endorsed.....  Community/         Percentage of patients  Centers for
                                                     Population         15-65 years of age      Disease Control
                                                     Health.            who have ever been      and Prevention
                                                                        tested for human        (CDC).
                                                                        immunodeficiency
                                                                        virus (HIV).
Total Resource Use Population-   1598.............  N/A..............  This measure is used    Minneapolis (MN):
 based PMPM Index (RUI).                                                to assess the total     Health Partners.
                                                                        resource use index
                                                                        population-based per
                                                                        member per month
                                                                        (PMPM). The Resource
                                                                        Use Index (RUI) is a
                                                                        risk adjusted measure
                                                                        of the frequency and
                                                                        intensity of services
                                                                        utilized to manage a
                                                                        provider group's
                                                                        patients. Resource
                                                                        use includes all
                                                                        resources associated
                                                                        with treating members
                                                                        including
                                                                        professional,
                                                                        facility inpatient
                                                                        and outpatient,
                                                                        pharmacy, lab,
                                                                        radiology, ancillary
                                                                        and behavioral health
                                                                        services.
----------------------------------------------------------------------------------------------------------------


[[Page 35941]]


                              Table 43--MIPS APM Measure List--Oncology Care Model
----------------------------------------------------------------------------------------------------------------
                                  NQF/Quality  ID    National quality                           Primary measure
          Measure name                  No.          strategy domain     Measure description        steward
----------------------------------------------------------------------------------------------------------------
Adjuvant chemotherapy is         0223.............  Communication and  Percentage of patients  Commission on
 recommended or administered                         Care               under the age of 80     Cancer, American
 within 4 months (120 days) of                       Coordination.      with AJCC III (lymph    College of
 diagnosis to patients under                                            node positive) colon    Surgeons.
 the age of 80 with AJCC III                                            cancer for whom
 (lymph node positive) colon                                            adjuvant chemotherapy
 cancer.                                                                is recommended and
                                                                        not received or
                                                                        administered within 4
                                                                        months (120 days) of
                                                                        diagnosis.
Breast Cancer: Hormonal Therapy  0387.............  Communication and  Percentage of female    AMA-convened
 for Stage I (T1b)-IIIC                              Care               patients aged 18        Physician
 Estrogen Receptor/Progesterone                      Coordination.      years and older with    Consortium for
 Receptor (ER/PR) Positive                                              Stage I (T1b) through   Performance
 Breast Cancer.                                                         IIIC, ER or PR          Improvement.
                                                                        positive breast
                                                                        cancer who were
                                                                        prescribed tamoxifen
                                                                        or aromatase
                                                                        inhibitor (AI) during
                                                                        the 12-month
                                                                        reporting period.
Oncology: Medical and            0384.............  Person and         Percentage of visits    American Society
 Radiation--Plan of Care for                         Caregiver-         for patients,           of Clinical
 Pain.                                               Centered           regardless of age,      Oncology.
                                                     Experience and     with a diagnosis of
                                                     Outcomes.          cancer currently
                                                                        receiving
                                                                        chemotherapy or
                                                                        radiation therapy who
                                                                        report having pain
                                                                        with a documented
                                                                        plan of care to
                                                                        address pain.
Combination chemotherapy is      0559.............  Communication and  Percentage of female    Commission on
 recommended or administered                         Care               patients, age >18 at    Cancer, American
 within 4 months (120 days) of                       Coordination.      diagnosis, who have     College of
 diagnosis for women under 70                                           their first diagnosis   Surgeons.
 with AJCC T1cN0M0, or Stage IB-                                        of breast cancer
 III hormone receptor negative                                          (epithelial
 breast cancer.                                                         malignancy), at AJCC
                                                                        stage T1cN0M0 (tumor
                                                                        greater than 1 cm),
                                                                        or Stage IB-III,
                                                                        whose primary tumor
                                                                        is progesterone and
                                                                        estrogen receptor
                                                                        negative recommended
                                                                        for multiagent
                                                                        chemotherapy
                                                                        (recommended or
                                                                        administered) within
                                                                        4 months (120 days)
                                                                        of diagnosis.
Documentation of Current         0419.............  Patient Safety...  Percentage of visits    CMS.
 Medications in the Medical                                             for patients aged 18
 Record.                                                                years and older for
                                                                        which the eligible
                                                                        clinician attests to
                                                                        documenting a list of
                                                                        current medications
                                                                        using all immediate
                                                                        resources available
                                                                        on the date of the
                                                                        encounter. This list
                                                                        must include ALL
                                                                        known prescriptions,
                                                                        over the counters,
                                                                        herbals, and vitamin/
                                                                        mineral/dietary AND
                                                                        must contain the
                                                                        medications' name,
                                                                        dosage, frequency and
                                                                        route of
                                                                        administration.
Oncology: Medical and            0383.............  Person and         Percentage of patient   Physician
 Radiation--Pain Intensity                           Caregiver          visits, regardless of   Consortium for
 Quantified.                                         Centered           patient age, with a     Performance
                                                     Experience.        diagnosis of cancer     Improvement
                                                                        currently receiving     Foundation.
                                                                        chemotherapy or
                                                                        radiation therapy in
                                                                        which pain intensity
                                                                        is quantified.
Patient-Reported Experience of   N/A..............  Person and         Summary/Survey          CMS.
 Care.                                               Caregiver-         Measures may include:
                                                     Centered           Overall
                                                     Experience and     measure of patient
                                                     Outcomes.          experience..
                                                                        Exchanging
                                                                        Information with
                                                                        Patients..
                                                                        Access.......
                                                                        Shared
                                                                        Decision Making..
                                                                        Enabling Self-
                                                                        Management..
                                                                        Affective
                                                                        Communication..
Preventive Care and Screening:   0418.............  Community/         Percentage of patients  CMS.
 Screening for Depression and                        Population         aged 12 and older
 Follow-Up Plan.                                     Health.            screened for
                                                                        depression on the
                                                                        date of the encounter
                                                                        using an age
                                                                        appropriate
                                                                        standardized
                                                                        depression screening
                                                                        tool and if positive,
                                                                        a follow-up plan is
                                                                        documented on the
                                                                        date of the positive
                                                                        screen.
Proportion of patients who died  N/A..............  N/A..............  Percentage of OCM-      CMS.
 who were admitted to hospice                                           attributed FFS
 for 3 days or more.                                                    beneficiaries who
                                                                        died and spent at
                                                                        least 3 days in
                                                                        hospice during the
                                                                        measurement time
                                                                        period.
Risk-adjusted proportion of      N/A..............  N/A..............  Percentage of OCM-      CMS.
 patients with all-cause ED                                             attributed FFS
 visits that did not result in                                          beneficiaries who had
 a hospital admission within                                            an ER visit that did
 the 6-month episode.                                                   not result in a
                                                                        hospital stay during
                                                                        the measurement
                                                                        period.

[[Page 35942]]

 
Risk-adjusted proportion of      N/A..............  N/A..............  Percentage of OCM-      CMS.
 patients with all-cause                                                attributed FFS
 hospital admissions within the                                         beneficiaries who
 6-month episode.                                                       were had an acute-
                                                                        care hospital stay
                                                                        during the
                                                                        measurement period.
Trastuzumab administered to      1858.............  Efficiency and     Proportion of female    American Society
 patients with AJCC stage I                          Cost reduction.    patients (aged 18       of Clinical
 (T1c)-III and human epidermal                                          years and older) with   Oncology.
 growth factor receptor 2                                               AJCC stage I (T1c)-
 (HER2) positive breast cancer                                          Ill, human epidermal
 who receive adjuvant                                                   growth factor
 chemotherapy.                                                          receptor 2 (HER2)
                                                                        positive breast
                                                                        cancer receiving
                                                                        adjuvant Chemotherapy.
----------------------------------------------------------------------------------------------------------------


                 Table 44--MIPS APM Measure List--Bundled Payments for Care Improvement Advanced
----------------------------------------------------------------------------------------------------------------
                                  NQF/Quality  ID    National quality                           Primary measure
          Measure name                  No.          strategy domain     Measure description        steward
----------------------------------------------------------------------------------------------------------------
All-Cause Hospital Readmission.  1789.............  Communication and  This measure estimates  CMS.
                                                     Care               a hospital-level risk-
                                                     Coordination.      standardized
                                                                        readmission rate
                                                                        (RSRR) of unplanned,
                                                                        all cause readmission
                                                                        after admission for
                                                                        any eligible
                                                                        condition within 30
                                                                        days of hospital
                                                                        discharge.
Advanced Care Plan.............  0326.............  Communication and  Percentage of patients  NCQA.
                                                     Care               aged 65 years and
                                                     Coordination.      older who have an
                                                                        advance care plan or
                                                                        surrogate decision
                                                                        maker documented in
                                                                        the medical record or
                                                                        documentation in the
                                                                        medical record that
                                                                        an advance care plan
                                                                        was discussed but the
                                                                        patient did not wish
                                                                        or was not able to
                                                                        name a surrogate
                                                                        decision maker or
                                                                        provide an advance
                                                                        care plan.
Perioperative Care: Selection    0268.............  Patient Safety...  Percentage of surgical  American Society
 of Prophylactic Antibiotic:                                            patients aged 18        of Plastic
 First or Second Generation                                             years and older         Surgeons.
 Cephalosporin.                                                         undergoing procedures
                                                                        with the indications
                                                                        for a first OR second
                                                                        generation
                                                                        cephalosporin
                                                                        prophylactic
                                                                        antibiotic who had an
                                                                        order for first OR
                                                                        second generation
                                                                        cephalosporin for
                                                                        antimicrobial
                                                                        prophylaxis.
Hospital-Level Risk-             2558.............  Patient Safety...  The measure estimates   CMS.
 Standardized Mortality Rate                                            a hospital-level,
 Following Elective Coronary                                            risk-standardized
 Artery Bypass Graft Surgery.                                           mortality rate (RSMR)
                                                                        for patients 18 years
                                                                        and older discharged
                                                                        from the hospital
                                                                        following a
                                                                        qualifying isolated
                                                                        CABG procedure.
                                                                        Mortality is defined
                                                                        as death from any
                                                                        cause within 30 days
                                                                        of the procedure date
                                                                        of an index CABG
                                                                        admission. The
                                                                        measure was developed
                                                                        using Medicare Fee-
                                                                        for-Service (FFS)
                                                                        patients 65 years and
                                                                        older and was tested
                                                                        in all-payer patients
                                                                        18 years and older.
                                                                        An index admission is
                                                                        the hospitalization
                                                                        for a qualifying
                                                                        isolated CABG
                                                                        procedure considered
                                                                        for the mortality
                                                                        outcome.

[[Page 35943]]

 
Excess Days in Acute Care After  2881.............  Patient Safety...  This measure assesses   CMS.
 Hospitalization for Acute                                              days spent in acute
 Myocardial Infarction.                                                 care within 30 days
                                                                        of discharge from an
                                                                        inpatient
                                                                        hospitalization for
                                                                        acute myocardial
                                                                        infarction (AMI) to
                                                                        provide a patient-
                                                                        centered assessment
                                                                        of the post-discharge
                                                                        period. This measure
                                                                        is intended to
                                                                        capture the quality
                                                                        of care transitions
                                                                        provided to
                                                                        discharged patients
                                                                        hospitalized with AMI
                                                                        by collectively
                                                                        measuring a set of
                                                                        adverse acute care
                                                                        outcomes that can
                                                                        occur post-discharge:
                                                                        Emergency department
                                                                        (ED) visits,
                                                                        observation stays,
                                                                        and unplanned
                                                                        readmissions at any
                                                                        time during the 30
                                                                        days post-discharge.
                                                                        In order to aggregate
                                                                        all three events, we
                                                                        measure each in terms
                                                                        of days. In 2016, CMS
                                                                        will begin annual
                                                                        reporting of the
                                                                        measure for patients
                                                                        who are 65 years or
                                                                        older, are enrolled
                                                                        in fee-for-service
                                                                        (FFS) Medicare, and
                                                                        are hospitalized in
                                                                        non-federal hospitals.
AHRQ Patient Safety Measures...  0531.............  Patient Safety...  The modified PSI-90     AHRQ.
                                                                        Composite measure
                                                                        (name changed to
                                                                        Patient Safety and
                                                                        Adverse Events
                                                                        Composite) consists
                                                                        of ten component
                                                                        indicators: PSI-3
                                                                        Pressure ulcer rate;
                                                                        PSI-6 Iatrogenic
                                                                        pneumothorax rate;
                                                                        PSI-8 Postoperative
                                                                        hip fracture rate;
                                                                        PSI-09 Perioperative
                                                                        hemorrage or hematoma
                                                                        rate; PSI-10
                                                                        hysiologic and
                                                                        metabolic derangement
                                                                        rate; PSI-11
                                                                        postoperative
                                                                        respiratory failure
                                                                        rate; PSI-12
                                                                        Perioperative
                                                                        pulmonary embolism or
                                                                        Deep vein thrombosis
                                                                        rate; PSI-13
                                                                        Postoperative sepsis
                                                                        rate; PSI-14
                                                                        Postoperative wound
                                                                        dehiscence rate; and
                                                                        PSI-15 Accidental
                                                                        puncture or
                                                                        laceration rate.
Hospital-Level Risk-             1550.............  Patient Safety...  The measure estimates   CMS.
 Standardized Complication Rate                                         a hospital-level risk-
 Following Elective Primary                                             standardized
 Total Hip Arthroplasty and/or                                          complication rate
 Total Knee Arthroplasty.                                               (RSCR) associated
                                                                        with elective primary
                                                                        THA and TKA in
                                                                        Medicare Fee-For-
                                                                        Service beneficiaries
                                                                        who are 65 years and
                                                                        older. The outcome
                                                                        (complication) is
                                                                        defined as any one of
                                                                        the specified
                                                                        complications
                                                                        occurring from the
                                                                        date of index
                                                                        admission to 90 days
                                                                        post date of the
                                                                        index admission (the
                                                                        admission included in
                                                                        the measure cohort).
----------------------------------------------------------------------------------------------------------------


                       Table 45--MIPS APM Measure List--Maryland Total Cost of Care Model
                                         [Maryland Primary Care Program]
----------------------------------------------------------------------------------------------------------------
                                  NQF/Quality  ID    National quality                           Primary measure
          Measure name                  No.          strategy domain     Measure description        steward
----------------------------------------------------------------------------------------------------------------
Controlling High Blood Pressure  0018.............  Effective          Percentage of patients  National
                                                     Treatment/         18-85 years of age      Committee for
                                                     Clinical Care.     who had a diagnosis     Quality
                                                                        of hypertension and     Assurance.
                                                                        whose blood pressure
                                                                        was adequately
                                                                        controlled (<140/90
                                                                        mmHg) during the
                                                                        measurement period.
Diabetes: Hemoglobin A1c         0059.............  Effective          Percentage of patients  National
 (HbA1c) Poor Control (>9%).                         Treatment/         18-75 years of age      Committee for
                                                     Clinical Care.     with diabetes who had   Quality
                                                                        hemoglobin A1c >9.0%    Assurance.
                                                                        during the
                                                                        measurement period.
Dementia: Cognitive Assessment.  2872.............  Effective          Percentage of           American Medical
                                                     Treatment/         patients, regardless    Association-
                                                     Clinical Care.     of age, with a          convened
                                                                        diagnosis of dementia   Physician
                                                                        for whom an             Consortium for
                                                                        assessment of           Performance
                                                                        cognition is            Improvement(R)
                                                                        performed and the       (AMA-PCPI).
                                                                        results reviewed at
                                                                        least once within a
                                                                        12-month period.

[[Page 35944]]

 
Falls: Screening for Future      0101.............  Patient Safety/    Percentage of patients  National
 Fall Risk.                                          Safety.            65 years of age and     Committee for
                                                                        older who were          Quality
                                                                        screened for future     Assurance.
                                                                        fall risk during the
                                                                        measurement period.
Initiation and Engagement of     004..............  Effective          Percentage of patients  National
 Alcohol and Other Drug                              Treatment/         13 years of age and     Committee for
 Dependence Treatment.                               Clinical Care.     older with a new        Quality
                                                                        episode of alcohol      Assurance.
                                                                        and other drug (AOD)
                                                                        dependence who
                                                                        received the
                                                                        following. Two rates
                                                                        are reported.
                                                                       a. Percentage of
                                                                        patients who
                                                                        initiated treatment
                                                                        within 14 days of the
                                                                        diagnosis..
                                                                       b. Percentage of
                                                                        patients who
                                                                        initiated treatment
                                                                        and who had two or
                                                                        more additional
                                                                        services with an AOD
                                                                        diagnosis within 30
                                                                        days of the
                                                                        initiation visit..
Closing the Referral Loop:       N/A..............  Communication and  Percentage of patients  CMS.
 Receipt of Specialist Report.                       Coordination/      with referrals,
                                                     Care               regardless of age,
                                                     Coordination.      for which the
                                                                        referring provider
                                                                        receives a report
                                                                        from the provider to
                                                                        whom the patient was
                                                                        referred.
Cervical Cancer Screening......  0032.............  Effective          Percentage of women 21- National
                                                     Treatment/         64 years of age, who    Committee for
                                                     Clinical Care.     were screened for       Quality
                                                                        cervical cancer using   Assurance.
                                                                        either of the
                                                                        following criteria.
                                                                        Women age 21-
                                                                        64 who had cervical
                                                                        cytology performed
                                                                        every 3 years..
                                                                        Women age 30-
                                                                        64 who had cervical
                                                                        cytology/human
                                                                        papillomavirus (HPV)
                                                                        co-testing performed
                                                                        every.
Colorectal Cancer Screening....  0034.............  Effective          Percentage of           National
                                                     Treatment/         patients, 50-75 years   Committee for
                                                     Clinical Care.     of age who had          Quality
                                                                        appropriate screening   Assurance.
                                                                        for colorectal cancer.
Diabetes: Eye Exam.............  0055.............  Effective          Percentage of patients  National
                                                     Treatment/         18-75 years of age      Committee for
                                                     Clinical Care.     with diabetes who had   Quality
                                                                        a retinal or dilated    Assurance.
                                                                        eye exam by an eye
                                                                        care professional
                                                                        during the
                                                                        measurement period or
                                                                        a negative retinal
                                                                        exam (no evidence of
                                                                        retinopathy) in the
                                                                        12 months prior to
                                                                        the measurement
                                                                        period.
Preventive Care and Screening:   0028.............  Healthy Living/    Percentage of patients  American Medical
 Tobacco Use: Screening and                          Population         aged 18 years and       Association-
 Cessation Intervention.                             Health and         older who were          convened
                                                     Prevention.        screened for tobacco    Physician
                                                                        use one or more times   Consortium for
                                                                        within 24 months and    Performance
                                                                        who received            Improvement(R)
                                                                        cessation counseling    (AMA-PCPI).
                                                                        intervention if
                                                                        identified as a
                                                                        tobacco user.
Breast Cancer Screening........  2372.............  Effective          Percentage of women 50- National
                                                     Treatment/         74 years of age who     Committee for
                                                     Clinical Care.     had a mammogram to      Quality
                                                                        screen for breast       Assurance.
                                                                        cancer.
CG-CAHPS Survey 3.0--modified    Not Endorsed.....  Person and Family  CG-CAHPS Survey 3.0...  AHRQ.
 for CPC+.                                           Engagement/
                                                     Patient and
                                                     Caregiver
                                                     Experience.
Inpatient Hospital Utilization.  Not Endorsed.....  Communication and  For members 18 years    National
                                                     Care               of age and older, the   Committee for
                                                     Coordination.      risk-adjusted ratio     Quality
                                                                        of observed to          Assurance.
                                                                        expected acute
                                                                        inpatient discharges
                                                                        during the
                                                                        measurement year
                                                                        reported by Surgery,
                                                                        Medicine, and Total.
Emergency Department             Not Endorsed.....  Communication and  For members 18 years    National
 Utilization.                                        Care               of age and older, the   Committee for
                                                     Coordination.      risk-adjusted ratio     Quality
                                                                        of observed to          Assurance.
                                                                        expected emergency
                                                                        department (ED)
                                                                        visits during the
                                                                        measurement year.
Diabetes: Medical Attention for  0062.............  Effective          The percentage of       National
 Nephropathy.                                        Treatment/         patients 18-75 years    Committee for
                                                     Clinical Care.     of age with diabetes    Quality
                                                                        who had a nephropathy   Assurance.
                                                                        screening test or
                                                                        evidence of
                                                                        nephropathy during
                                                                        the measurement
                                                                        period.
Preventive Care and Screening:   0418.............  Community/         Percentage of patients  CMS.
 Depression and Follow-Up Plan.                      Population         aged 12 years and
                                                     Health.            older screened for
                                                                        depression on the
                                                                        date of the encounter
                                                                        using an age
                                                                        appropriate
                                                                        standardized
                                                                        depression screening
                                                                        tool AND if positive,
                                                                        a follow-up plan is
                                                                        documented on the
                                                                        date of the positive
                                                                        screen.

[[Page 35945]]

 
Depression Utilization of the    0712.............  Effective          The percentage of       MN Community
 PHQ-9 Tool.                                         Treatment/         patients age 18 and     Measurement.
                                                     Clinical Care.     older with the
                                                                        diagnosis of major
                                                                        depression or
                                                                        dysthymia who have a
                                                                        completed PHQ-9
                                                                        during each
                                                                        applicable 4 month
                                                                        period in which there
                                                                        was a qualifying
                                                                        visit.
Preventive Care and Screening:   0041.............  Healthy Living/    Percentage of patients  American Medical
 Influenza Immunization.                             Population         aged 6 months and       Association-
                                                     Health and         older seen for a        convened
                                                     Prevention.        visit between October   Physician
                                                                        1 and March 31 who      Consortium for
                                                                        received an influenza   Performance
                                                                        immunization OR who     Improvement(R)
                                                                        reported previous       (AMA-PCPI).
                                                                        receipt of an
                                                                        influenza
                                                                        immunization.
Pneumococcal Vaccination Status  0043.............  Healthy Living/    Percentage of patients  National
 for Older Adults.                                   Population         65 years of age and     Committee for
                                                     Health and         older who have ever     Quality
                                                     Prevention.        received a              Assurance.
                                                                        pneumococcal vaccine.
Ischemic Vascular Disease        0068.............  Effective          Percentage of patients  National
 (IVD): Use of Aspirin or                            Treatment/         18 years of age and     Committee for
 Another Antiplatelet.                               Clinical Care.     older who were          Quality
                                                                        diagnosed with acute    Assurance.
                                                                        myocardial infarction
                                                                        (AMI), coronary
                                                                        artery bypass graft
                                                                        (CABG) or
                                                                        percutaneous coronary
                                                                        interventions (PCI)
                                                                        in the 12 months
                                                                        prior to the
                                                                        measurement period,
                                                                        or who had an active
                                                                        diagnosis of ischemic
                                                                        vascular disease
                                                                        (IVD) during the
                                                                        measurement period,
                                                                        and who had
                                                                        documentation of use
                                                                        of aspirin or another
                                                                        antiplatelet during
                                                                        the measurement
                                                                        period.
Statin Therapy for the           Not Endorsed.....  Effective          Percentage of the       CMS.
 Prevention and Treatment of                         Treatment/         following patients--
 Cardiovascular Disease.                             Clinical Care.     all considered at
                                                                        high risk of
                                                                        cardiovascular
                                                                        events--who were
                                                                        prescribed or were on
                                                                        statin therapy during
                                                                        the measurement
                                                                        period:
                                                                        Adults aged
                                                                        >=21 years who were
                                                                        previously diagnosed
                                                                        with or currently
                                                                        have an active
                                                                        diagnosis of clinical
                                                                        atherosclerotic
                                                                        cardiovascular
                                                                        disease (ASCVD); OR.
                                                                        Adults aged
                                                                        >=21 years who have
                                                                        ever had a fasting or
                                                                        direct low-density
                                                                        lipoprotein
                                                                        cholesterol (LDL-C)
                                                                        level >=190 mg/dL or
                                                                        were previously
                                                                        diagnosed with or
                                                                        currently have an
                                                                        active diagnosis of
                                                                        familial or pure
                                                                        hypercholesterolemia;
                                                                        OR.
                                                                        Adults aged
                                                                        40-75 years with a
                                                                        diagnosis of diabetes
                                                                        with a fasting or
                                                                        direct LDL-C level of
                                                                        70-189 mg/dL.
Use of High-Risk Medications in  0022.............  Patient Safety/    Percentage of patients  National
 the Elderly.                                        Safety.            65 years of age and     Committee for
                                                                        older who were          Quality
                                                                        ordered high-risk       Assurance.
                                                                        medications.
----------------------------------------------------------------------------------------------------------------


                       Table 46--MIPS APM Measure List--Independence at Home Demonstration
----------------------------------------------------------------------------------------------------------------
                                  NQF/Quality  ID    National quality                           Primary measure
          Measure name                  No.          strategy domain     Measure description        steward
----------------------------------------------------------------------------------------------------------------
Number of inpatient admissions   Not Endorsed.....  N/A..............  Number of inpatient     CMS.
 for ambulatory-care sensitive                                          admissions for
 conditions per 100 patient                                             ambulatory-care
 enrollment months.                                                     sensitive conditions
                                                                        per 100 patient
                                                                        enrollment months.
Number of readmissions within    Not Endorsed.....  N/A..............  Risk adjusted           CMS.
 30 days per 100 inpatient                                              readmissions to a
 discharges.                                                            hospital within 30
                                                                        days following
                                                                        discharge from the
                                                                        hospital for an index
                                                                        admission.
Emergency Department Visits for  Not Endorsed.....  N/A..............  Risk adjusted           CMS.
 Ambulatory Care Sensitive                                              emergency department
 Conditions.                                                            visits for three
                                                                        ambulatory care
                                                                        sensitive conditions:
                                                                        diabetes, congestive
                                                                        heart failure (CHF),
                                                                        and chronic
                                                                        obstructive pulmonary
                                                                        disease (COPD).

[[Page 35946]]

 
Contact with beneficiaries       Not Endorsed.....  N/A..............  Percent of hospital     CMS.
 within 48 hours upon admission                                         admissions, hospital
 to the hospital and discharge                                          discharges, and
 from the hospital and/or ED.                                           emergency department
                                                                        (ED) visits for
                                                                        beneficiaries
                                                                        enrolled in IAH with
                                                                        a follow-up contact
                                                                        within 48 hours.
Medication reconciliation in     Not Endorsed.....  N/A..............  Percent of hospital     CMS.
 the home.                                                              discharges and
                                                                        emergency department
                                                                        (ED) visits for
                                                                        beneficiaries
                                                                        enrolled in IAH with
                                                                        medication
                                                                        reconciliation in the
                                                                        home within 48 hours.
Percentage with Documented       Not Endorsed.....  N/A..............  Percent of              CMS.
 Patient Preferences.                                                   beneficiaries
                                                                        enrolled in IAH with
                                                                        patient preferences
                                                                        documented in the
                                                                        medical record for a
                                                                        demonstration year.
----------------------------------------------------------------------------------------------------------------

i. MIPS Final Score Methodology
(1) Converting Measures and Activities Into Performance Category Scores
(a) Background
    For the 2021 MIPS payment year, we intend to build on the scoring 
methodology we finalized for the transition years, which allows for 
accountability and alignment across the performance categories and 
minimizes burden on MIPS eligible clinicians. The rationale for our 
scoring methodology continues to be grounded in the understanding that 
the MIPS scoring system has many components and various moving parts.
    As we continue to move forward in implementing the MIPS program, we 
strive to balance the statutory requirements and programmatic goals 
with the ease of use, stability, and meaningfulness for MIPS eligible 
clinicians. We do so while also emphasizing simplicity and the 
continued development of a scoring methodology that is understandable 
for MIPS eligible clinicians.
    In the CY 2017 Quality Payment Program final rule, we finalized a 
unified scoring system to determine a final score across the 4 
performance categories (81 FR 77273 through 77276). For the 2019 MIPS 
performance period, we propose to build on the scoring methodology we 
previously finalized, focusing on encouraging MIPS eligible clinicians 
to meet data completeness requirements. For the quality performance 
category scoring, we propose to extend some of the transition year 
policies to the 2019 MIPS performance period, and we are also proposing 
several modifications to existing policies. In the CY 2018 Quality 
Payment Program final rule (82 FR 53712 through 53714), we established 
a methodology for scoring improvement in the cost performance category. 
However, as required by section 51003(a)(1)(B) of the Bipartisan Budget 
Act of 2018, we propose that the cost performance category score would 
not take into account improvement until the 2024 MIPS payment year. In 
the CY 2018 Quality Payment Program final rule (82 FR53753 through 
53767), we finalized the availability of a facility-based measurement 
option for clinicians who met certain requirements, beginning with the 
2019 MIPS performance period; in section III.H.3.i.(1)(d) of this 
proposed rule, we propose to change the determination of facility-based 
measurement to include consideration of presence in the on-campus 
outpatient hospital. The policies for scoring the 4 performance 
categories are described in detail in section III.H.3.i.(1) of this 
proposed rule.
    These sets of proposed policies will help eligible clinicians as 
they participate in the 2019 MIPS performance period/2021 MIPS payment 
year, and as we move beyond the transition years of the program. 
Section 51003 of the Bipartisan Budget Act of 2018 provides flexibility 
to continue the gradual ramp up of the Quality Payment Program and 
enables us to extend some of the transition year policies to the 2019 
performance period.
    Unless otherwise noted, for purposes of this section III.H.3.i. of 
this proposed rule on scoring, the term ``MIPS eligible clinician'' 
will refer to MIPS eligible clinicians who collect and submit data and 
are scored at either the individual or group level, including virtual 
groups; it will not refer to MIPS eligible clinicians who are scored by 
facility-based measurement, as discussed in section III.H.3.i.(1)(d) of 
this proposed rule. We also note that the APM scoring standard applies 
to MIPS eligible clinicians in APM Entities in MIPS APMs, and those 
policies take precedence where applicable. Where those policies do not 
apply, scoring for MIPS eligible clinicians as described in section 
III.H.3.h.(6) of this proposed rule will apply. We refer readers to 
section III.H.4. of this proposed rule for additional information about 
the APM scoring standard.
(b) Scoring the Quality Performance Category for the Following 
Collection Types: Part B Claims Measures, eCQMs, MIPS CQMs, QCDR 
Measures, CMS Web Interface Measures, the CAHPS for MIPS Survey Measure 
and Administrative Claims Measures
    Although we do not propose changing the basic scoring system that 
we finalized in the CY 2018 Quality Payment Program final rule for the 
2021 MIPS payment year (82 FR 53712 through 53748), we are proposing 
several modifications to scoring the quality performance category, 
including removing high-priority measure bonus points for CMS Web 
Interface measures and extending the bonus point caps, and adding a 
small practice bonus to the quality performance category score. The 
following section describes these previously finalized policies and our 
new proposals.
    We are also proposing updates to Sec.  414.1380(b)(1) in an effort 
to more clearly and concisely capture previously established policies. 
These proposed updates are not intended to be substantive in nature, 
but rather to bring more clarity to the regulatory text. We will make 
note of the updated regulatory citations in their relevant sections 
below.
(i) Scoring Terminology
    In the CY 2017 and CY 2018 Quality Payment Program final rules (81 
FR 77008 through 77831, and 82 FR 53568 through 54229, respectively), 
we used the term ``submission mechanisms'' in reference to the various 
ways in which a MIPS eligible clinician or group can submit data to 
CMS. As discussed in section III.H.3.h.(1)(b) of this proposed

[[Page 35947]]

rule, it has come to our attention that the way we have described the 
various ways in which MIPS eligible clinicians, groups and third-party 
intermediaries can submit data to our systems does not accurately 
reflect the experience users have when submitting data to us. We refer 
readers to section III.H.3.h.(1)(b) of this proposed rule for further 
discussion on our proposed changes to the scoring terminology related 
to measure specification and data collection and submission. For 
additional discussion on the impact of the proposed terminology change 
on our benchmarking methodology, validation process, and end-to-end 
reporting bonus, we refer readers to sections III.H.3.i.(1)(b)(ii), 
(v), and (x) of this proposed rule.
(ii) Quality Measure Benchmarks
    We refer readers to the CY 2017 and CY 2018 Quality Payment Program 
final rules (81 FR 77282, and 82 FR 53718, respectively) for our 
previously established benchmarking policies. As part of our proposed 
technical updates to Sec.  414.1380(b)(1) discussed in section 
III.H.3.i.(1)(a)(i) of this proposed rule, our previously established 
benchmarking policies at Sec.  414.1380(b)(1)(i) through (iii) would 
now be referenced at Sec.  414.1380(b)(1)(i) through (ii).
    In the CY 2018 Quality Payment Program final rule, we solicited 
comments on how we could improve our method of benchmarking quality 
measures (82 FR 53718 through 53719). Several commenters provided 
suggestions on improving our benchmarking methodology including 
reconciling the differences between the MIPS and Physician Compare 
benchmarking methodologies. Several other commenters expressed concerns 
that the methodology may not reflect performance because, among other 
reasons, commenters believed that the benchmarks use data from a small 
number of clinicians, are based on various legacy programs, and create 
ranging point variances based on collection type.
    When we developed the quality measure benchmarks, we sought to 
develop a system that enables MIPS eligible clinicians, beneficiaries, 
and other stakeholders to understand what is required for a strong 
performance in MIPS while being consistent with statutory requirements 
(81 FR 28249 through 28250). The feedback we have received thus far 
from stakeholders on our benchmarks is helping to inform our approach 
to the benchmarking methodology, especially as we look for possible 
ways of aligning with Physician Compare benchmarks. As described in 
section III.H.3.i.(1)(b)(xii) of this proposed rule, we are seeking 
comment on potential future approaches to scoring the quality 
performance category to continue to promote value and improved 
outcomes. We anticipate changes in scoring would be paired with 
potential modifications to measure selection and criteria discussed in 
section III.H.3.h.(2)(b) of this proposed rule. We are looking for 
opportunities to further reduce confusion about our benchmarking 
methodology described in the CY 2017 Quality Payment Program final rule 
(81 FR 77277 through 77278), which includes further clarification of 
our benchmarking process and potential areas of alignment between the 
MIPS and Physician Compare benchmarking methodologies. We will take 
commenters' suggestions into consideration in future rulemaking.
(A) Revised Terminology for MIPS Benchmarks
    We previously established at Sec.  414.1380(b)(1)(iii) separate 
benchmarks for the following submission mechanisms: EHR; QCDR/registry, 
claims; CMS Web Interface; CMS-approved survey vendor; and 
administrative claims. We are not proposing to change our basic 
approach to our benchmarking methodology; however, we are proposing to 
amend Sec.  414.1380(b)(1)(ii) consistent with the proposed data 
submission terminology changes discussed in section III.H.3.h.(1)(b) of 
this proposed rule. Specifically, beginning with the 2021 MIPS payment 
year, we propose to establish separate benchmarks for the following 
collection types: eCQMs; QCDR measures (as described at Sec.  
414.1400(e)); MIPS CQMs; Medicare Part B claims measures; CMS Web 
Interface measures; the CAHPS for MIPS survey; and administrative 
claims measures. We would apply benchmarks based on collection type 
rather than submission mechanism. For example, for an eCQM, we would 
apply the eCQM benchmark regardless of submitter type (MIPS eligible 
clinician, group, third party intermediary). In addition, we would 
establish separate benchmarks for QCDR measures and MIPS CQMs since 
these measures do not have comparable specifications. In addition, we 
note that our proposed benchmarking policy allows for the addition of 
future collection types as the universe of measures continues to evolve 
and as new technology is introduced. Specifically, we propose to amend 
Sec.  414.1380(b)(1)(ii) to remove the mention of each individual 
benchmark and instead state that benchmarks will be based on collection 
type, from all available sources, including MIPS eligible clinicians 
and APMs, to the extent feasible, during the applicable baseline or 
performance period.
(iii) Assigning Points Based on Achievement
    In the CY 2017 Quality Payment Program final rule, we established 
the policies for scoring quality measures performance (81 FR 77286). We 
refer readers to Sec.  414.1380(b)(1) for more on these policies.
(A) Floor for Scored Quality Measures
    For the 2019 and 2020 MIPS payment years, we finalized at Sec.  
414.1380(b)(1)(i) a global 3-point floor for each scored quality 
measure, as well as for the hospital readmission measure (if 
applicable). In this way, MIPS eligible clinicians would receive 
between 3 and 10 measure achievement points for each submitted measure 
that can be reliably scored against a benchmark, which requires meeting 
the case minimum and data completeness requirements (81 FR 77286 
through 77287; 82 FR 53719). For measures with a benchmark based on the 
performance period (rather than on the baseline period), we stated that 
we would continue to assign between 3 and 10 measure achievement points 
for performance periods after the first transition year (81 FR 77282, 
77287; 82 FR 53719). For measures with benchmarks based on the baseline 
period, we stated that the 3-point floor was for the transition year 
and that we would revisit the 3-point floor in future years (81 FR 
77286 through 77287; 82 FR 53719).
    For the 2021 MIPS payment year, we propose to again apply a 3-point 
floor for each measure that can be reliably scored against a benchmark 
based on the baseline period, and to amend Sec.  414.1380(b)(1)(i) 
accordingly. We will revisit the 3-point floor for such measures again 
in future rulemaking.
(B) Additional Policies for the CAHPS for MIPS Measure Score
    While participating in the CAHPS for MIPS survey is optional for 
all groups, some groups will be unable to participate in the CAHPS for 
MIPS survey because they do not meet the minimum beneficiary sampling 
requirements. CMS has sampling requirements for groups of 100 or more 
eligible clinicians, 25 to 99 eligible clinicians, and 2 to 24 eligible 
clinicians to ensure an adequate number of survey responses and the 
ability to reliably report data. Our sampling timeframes (82 FR 53630 
through 53632) necessitate notifying groups of their inability to

[[Page 35948]]

meet the sampling requirements late in the performance period (see 82 
FR 53630 through 53632). As a result, we are concerned that some groups 
that expect and plan to meet the quality performance category 
requirements using the CAHPS for MIPS survey may find out late in the 
performance period that they are unable to meet the sampling 
requirements and, therefore, are unable to have their performance 
assessed on this measure. These groups may need to report on another 
measure to meet the requirements of the quality performance category.
    We want to encourage the reporting of the CAHPS for MIPS survey and 
do not want the uncertainty regarding sampling requirements to be a 
barrier to selecting the CAHPS for MIPS survey. To mitigate this 
concern, beginning with the 2021 MIPS payment year, we are proposing to 
reduce the denominator (that is, the total available measure 
achievement points) for the quality performance category by 10 points 
for groups that register for the CAHPS for MIPS survey but do not meet 
the minimum beneficiary sampling requirements. By reducing the 
denominator instead of only assigning the group a score of zero measure 
achievement points (because the group would be unable to submit any 
CAHPS for MIPS survey data), we are effectively removing the impact of 
the group's inability to submit the CAHPS for MIPS survey. We believe 
this reduction in denominator would remove any need for groups to find 
another measure if they are unable to submit the CAHPS for MIPS survey. 
Therefore, we propose to amend Sec.  414.1380 to add paragraph 
(b)(1)(vii)(B) to state that we will reduce the total available measure 
achievement points for the quality performance category by 10 points 
for groups that registered for the CAHPS for MIPS survey but do not 
meet the minimum beneficiary sampling requirements.
    We do not want groups to register for the CAHPS for MIPS survey if 
they know in advance that they are unlikely to be able to meet the 
sampling requirement, so we seek comment on whether we should limit 
this proposed policy to groups for only one MIPS performance period. 
For example, for the performance period following the application of 
this proposed policy, a notice could be provided to groups during 
registration indicating that if the sampling requirement is not met for 
a second consecutive performance period, the proposed policy will not 
be applied. This would provide notice to the group that they may not 
meet the sampling requirement needed for the CAHPS for MIPS survey and 
may need to look for alternate measures, but does not preclude the 
group from registering for the CAHPS for MIPS survey if they expect to 
meet the minimum beneficiary sampling requirements in the second MIPS 
performance period.
(iv) Assigning Measure Achievement Points for Topped Out Measures
    We refer readers to CY 2017 Quality Payment Program final rule (82 
FR 53721 through 53727) for our established policies for scoring topped 
out measures.
    Under Sec.  414.1380(b)(1)(xiii)(A), for the 2020 MIPS payment 
year, six measures will receive a maximum of 7 measure achievement 
points, provided that the applicable measure benchmarks are identified 
as topped out again in the benchmarks published for the 2018 MIPS 
performance period. Under Sec.  414.1380(b)(1)(xiii)(B), beginning with 
the 2021 MIPS payment year, measure benchmarks (except for measures in 
the CMS Web Interface) that are identified as topped out for 2 or more 
consecutive years will receive a maximum of 7 measure achievement 
points beginning in the second year the measure is identified as topped 
out (82 FR 53726 through 53727). As part of our technical updates to 
Sec.  414.1380(b)(1) outlined in section III.H.3.i.(1)(b) of this 
proposed rule, our finalized topped out scoring policies are now 
referenced at Sec.  414.1380(b)(1)(iv).
    We refer readers to the 2018 MIPS Quality Benchmarks' file, that is 
located on the Quality Payment Program resource library (https://www.cms.gov/Medicare/Quality-Payment-Program/Resource-Library/Resource-library.html) to determine which measure benchmarks are topped out for 
2018 and would be subject to the cap if they are also topped out in the 
2019 MIPS Quality Benchmarks' file. We note that the final 
determination of which measure benchmarks are subject to the topped out 
cap will not be available until the 2019 MIPS Quality Benchmarks' file 
is released in late 2018.
    We did not propose to apply our previously finalized topped out 
scoring policy to the CAHPS for MIPS survey (82 FR 53726). Because the 
CAHPS for MIPS survey was revised in 2018 (82 FR 53632), we do not have 
historical benchmarks for the 2018 performance period, so the topped 
out policy would not be applied for the 2019 performance period. Last 
year, we received limited feedback when we sought comment on how the 
topped out scoring policy should be applied to CAHPS for MIPS survey. 
In this proposed rule, we are seeking feedback on potential ways we can 
score CAHPS for MIPS Summary Survey Measures (SSM). For example, we 
could score all SSMs, which means there would effectively be no topped 
out scoring for CAHPS for MIPS SSMs, or we could cap the SSMs that are 
topped out and score all other SSMs. We seek comment on these 
approaches and additional approaches to the topped out scoring policy 
for CAHPS for MIPS SSMs. We note that we would like to encourage groups 
to report the CAHPS for MIPS survey as it incorporates beneficiary 
feedback.
(v) Scoring Measures That Do Not Meet Case Minimum, Data Completeness, 
and Benchmarks Requirements
    In the CY 2017 Quality Payment Program final rule (81 FR 77288 
through 77289), we established scoring policies for a measure that is 
submitted but is unable to be scored because it does not meet the 
required case minimum, does not have a benchmark, or does not meet the 
data completeness requirement. As part of our proposed technical 
updates to Sec.  414.1380(b)(1) discussed in section III.H.3.i.(1)(b) 
of this proposed rule, our previous scoring policies are now referenced 
at Sec.  414.1380(b)(1)(i)(A) and (B).
    A summary of the current and proposed policies is provided in Table 
47. For more of the statutory background and details on current 
policies, we refer readers to the CY 2017 and CY 2018 Quality Payment 
Program final rules (81 FR 77288 through 77289 and 82 FR 53727 through 
53730, respectively).

        Table 47--Quality Performance Category: Scoring Measures
------------------------------------------------------------------------
     Measure type             Description             Scoring rules
------------------------------------------------------------------------
Class 1...............  For the 2018 and 2019    For the 2018 and 2019
                         MIPS performance         MIPS performance
                         period:                  period:
                           Measures that can be     3 to 10 points based
                            scored based on          on performance
                            performance.             compared to the
                        Measures that were           benchmark.
                         submitted or
                         calculated that met
                         the following
                         criteria:.

[[Page 35949]]

 
                           (1) Has a benchmark;
                           (2) Has at least 20
                            cases; and.
                           (3) Meets the data
                            completeness
                            standard (generally
                            60 percent)..
Class 2...............  For the 2018 and 2019    For the 2018 and 2019
                         MIPS performance         MIPS performance
                         period:                  period:
                           Measures that were       3 points.
                            submitted and meet   * This Class 2 measure
                            data completeness,    policy does not apply
                            but do not have       to CMS Web Interface
                            both of the           measures and
                            following:.           administrative claims
                        (1) a benchmark........   based measures.
                        (2) at least 20 cases..
Class 3 **............  For the 2018 and 2019    For the 2018 and 2019
                         MIPS performance         MIPS performance
                         period:                  period:
                           Measures that were       1 point except for
                            submitted, but do        small practices,
                            not meet data            which would receive
                            completeness             3 measure
                            criteria,                achievement points.
                            regardless of        Beginning with the 2020
                            whether they have a   MIPS performance
                            benchmark or meet     period:
                            the case minimum..   MIPS eligible
                                                  clinicians other than
                                                  small practices will
                                                  receive zero measure
                                                  achievement points.
                                                  Small practices will
                                                  continue to receive 3
                                                  points.
                                                 * This Class 3 measure
                                                  policy would not apply
                                                  to CMS Web Interface
                                                  measures and
                                                  administrative claims
                                                  based measures.
------------------------------------------------------------------------

    As the MIPS program continues to mature, we are looking to find 
ways to improve our policies, including what to do with measures that 
do not meet the case minimum. While many MIPS eligible clinicians can 
meet the 20-case minimum requirement, we recognize that small practices 
and individual MIPS eligible clinicians may have difficulty meeting 
this standard. While we process data from the CY 2017 MIPS performance 
period to determine how often submitted measures do not meet case 
minimums, we invite public comment on ways we can improve our case-
minimum policy. In determining future improvements to our case minimum 
policy, our goal is to balance the concerns of MIPS eligible clinicians 
who are unable to meet the case minimum requirement and for whom we 
cannot capture enough data to reliably measure performance, while not 
creating incentives for MIPS eligible clinicians to choose measures 
that do not meet case minimum even though other more relevant measures 
are available.
    We propose to maintain the policies finalized for the CY 2018 MIPS 
performance period regarding measures that do not meet the case-minimum 
requirement, do not have a benchmark, or do not meet the data-
completeness criteria for the CY 2019 MIPS performance period, and to 
amend Sec.  414.1380(b)(1)(i) accordingly.
    We also propose to assign zero points for measures that do not meet 
data completeness starting with the CY 2020 MIPS performance period and 
to amend Sec.  414.1380(b)(1)(i)(B)(1) accordingly. This policy is part 
of our effort to move toward complete and accurate reporting that 
reflects meaningful effort to improve the quality of care that patients 
receive. Measures submitted by small practices would continue to 
receive 3 points for all future CY MIPS performance periods, although 
we may revisit this policy through future rulemaking.
(vi) Scoring Flexibility for Measures With Clinical Guideline Changes 
During the Performance Period
    In the CY 2018 Quality Payment Program final rule (82 FR 53714 
through 53716), we finalized that, beginning with the 2018 MIPS 
performance period, we will assess performance on measures considered 
significantly impacted by ICD-10 updates based only on the first 9 
months of the 12-month performance period (for example, January 1, 
2018, through September 30, 2018, for the 2018 MIPS performance 
period). We noted that performance on measures that are not 
significantly impacted by changes to ICD-10 codes would continue to be 
assessed on the full 12-month performance period (January 1 through 
December 31). Lastly, we finalized that we will publish the list of 
measures requiring a 9-month assessment process on the CMS website by 
October 1st of the performance period if technically feasible, but by 
no later than the beginning of the data submission period (for example, 
January 2, 2019, for the 2018 MIPS performance period). As part of our 
technical updates to Sec.  414.1380(b)(1) outlined in section 
III.H.3.i.(1)(b) of this proposed rule, these policies are now 
referenced at Sec.  414.1380(b)(1)(viii).
    We remain concerned about instances where clinical guideline 
changes or other changes to evidence supporting a measure occur during 
the performance period that may significantly impact a measure. 
Clinical guidelines and protocols developed by clinical experts and 
specialty medical societies often underpin quality measures. At times, 
measure stewards must amend quality measures to reflect new research 
and changed clinical guidelines, and sometimes, as a result of the 
change in these guidelines, adherence to guidelines in the existing 
measures could result in patient harm or otherwise provide misleading 
results as to good quality care. We sought comment in the CY 2018 
Quality Payment Program final rule regarding whether we should apply 
scoring flexibility to measures significantly impacted by clinical 
guideline changes (82 FR 53716).
    A few commenters made suggestions. One commenter supported using an 
approach similar to the one used for measures impacted by ICD-10 
changes. One commenter also recommended that the process be evaluated 
periodically. A few commenters did not support CMS scoring measures 
with less than 12 months of data because the commenters believed this 
may result in unsuccessful reporting and could affect the measure 
logic. One commenter recommended engaging measure developers and/or 
stewards and measure implementers who may have novel approaches for 
accounting for ICD-10 and other significant changes, such as releasing 
new measure guidance or suspending updates to the measure until the 
following performance period. The commenter also recommended that, for 
each measure with a significant change, CMS post the proposed approach 
for scoring the measure on the Quality

[[Page 35950]]

Payment Program website for a 30-day public comment period.
    We remain concerned that findings of evidence-based research, 
providing the basis for sound clinical practice guidelines and 
recommendations that are the foundation of a quality measure, may 
change outside of the rulemaking cycle. As the clinical evidence and 
guidelines change, approved measures may no longer reflect the most up-
to-date clinical evidence and could be contrary to patient well-being. 
There may be instances in which changes to clinical guidelines are so 
significant, that an expedited review is needed outside of the 
rulemaking cycle because measures may result in a practice that is 
harmful to patients. To further align with policies adopted within 
other value based programs such as the Hospital VBP Program (83 FR 
20409), we are proposing to suppress a measure without rulemaking, if 
during the performance period a measure is significantly impacted by 
clinical guideline changes or other changes that CMS believes may pose 
patient safety concerns. CMS would rely on measure stewards for 
notification in changes to clinical guidelines. We will publish on the 
CMS website suppressed measures whenever technically feasible, but by 
no later than the beginning of the data submission period.
    We propose policies to provide scoring flexibility in the event 
that we need to suppress a measure during a performance period. Scoring 
for a suppressed measure would result in a zero achievement points for 
the measure and a reduction of the total available measure achievement 
points by 10 points. We believe that this approach effectively removes 
the impact of the eligible clinician's inability to receive measure 
achievement points for the measure, if a submitted measure is later 
suppressed.
    We propose to add a new paragraph at Sec.  414.1380(b)(1)(vii) that 
beginning with the 2019 MIPS performance period, CMS will reduce the 
total available measure achievement points for the quality performance 
category by 10 points for MIPS eligible clinicians that submit a 
measure significantly impacted by clinical guideline changes or other 
changes that CMS believes may pose patient safety concerns.
(vii) Scoring for MIPS Eligible Clinicians That Do Not Meet Quality 
Performance Category Criteria
    In the CY 2018 Quality Payment Program final rule (82 FR 53732), we 
finalized that, beginning with the 2021 MIPS payment year, we will 
validate the availability and applicability of quality measures only 
with respect to the collection type that a MIPS eligible clinician 
utilizes for the quality performance category for a performance period, 
and only if a MIPS eligible clinician collects via claims only, MIPS 
CQMs only, or a combination of MIPS CQMs and claims collection types. 
We will not apply the validation process to any data collection type 
that the MIPS eligible clinician does not utilize for the quality 
performance category for the performance period. We sought comment on 
how to modify the validation process for the 2021 MIPS payment year 
when clinicians may submit measures collected via multiple collection 
types.
    As discussed in section III.H.3.h.(1)(b) of this proposed rule, we 
are proposing to revise our terminology regarding data submission. This 
updated terminology will more accurately reflect our current 
submissions and validation policies. We propose to modify our 
validation process to provide that it only applies to MIPS CQMs and the 
claims collection type, regardless of the submitter type chosen. For 
example, this policy would not apply to eCQMs even if they are 
submitted by a registry.
    We note that a MIPS eligible clinician may not have available and 
applicable quality measures. If we are unable to score the quality 
performance category, then we may reweight the clinician's score 
according to the reweighting policies described in sections 
III.H.3.i.(2)(b)(ii) and III.H.3.i.(2)(b)(iii) of this proposed rule.
(viii) Small Practice Bonus
    In the CY 2018 Quality Payment Program final rule, we finalized at 
Sec.  414.1380(c)(4) to add a small practice bonus of 5 points to the 
final score for the 2020 MIPS payment year for MIPS eligible 
clinicians, groups, APM Entities, and virtual groups that meet the 
definition of a small practice as defined at Sec.  414.1305 and submit 
data on at least one performance category in the 2018 MIPS performance 
period.
    We continue to believe an adjustment for small practices is 
generally appropriate due to the unique challenges small practices 
experience related to financial and other resources, as well as the 
performance gap we have observed (based on historical PQRS data) for 
small practices in comparison to larger practices. We believe a small 
practice bonus specific to the quality performance category is 
preferable for the 2021 MIPS payment year and future years. We believe 
it is appropriate to apply a small practice bonus points to the quality 
performance category based on observations using historical data, which 
indicates that small practices are less likely to submit quality 
performance data, less likely to report as a group and use the CMS Web 
Interface, and more likely to have lower performance rates in the 
quality performance category than other practices. We want the final 
score to reflect performance, rather than the ability and 
infrastructure to support submitting quality performance category data.
    We considered whether we should continue to apply the small 
practice bonus through bonus points in all four performance categories, 
but believe the need for doing so is less compelling. The improvement 
activities performance category already includes special scoring for 
small practices (please refer to Sec.  414.1380(b)(3) and see section 
III.H.3.i.(1)(e) of this proposed rule for more information). In 
addition, for the Promoting Interoperability performance category, 
small practices can apply for a significant hardship exception if they 
have issues acquiring an EHR (see section III.H.3.h.(5) of this 
proposed rule). Finally, the cost performance category does not require 
submission of any data; therefore, there is less concern about a small 
practice being burdened by those requirements. For these reasons, we 
are proposing to transition the small practice bonus to the quality 
performance category.
    Starting with the 2021 MIPS payment year, we propose at Sec.  
414.1380(b)(1)(v)(C) to add a small practice bonus of 3 points in the 
numerator of the quality performance category for MIPS eligible 
clinicians in small practices if the MIPS eligible clinician submits 
data to MIPS on at least 1 quality measure. Because MIPS eligible 
clinicians in small practices are not measured on the readmission 
measure and are not able to participate in the CMS Web Interface, they 
generally have a quality performance category denominator of 60 total 
possible measure achievement points. Thus, our proposal of 3 measure 
bonus points generally represents 5 percent of the quality performance 
category score. As described in section III.H.3.i.(2)(b)(iii) of this 
proposed rule, for clinicians in many small practices, the quality 
performance category weight may be up to 85 percent of the final score. 
(For example, if a small practice applies for the Promoting 
Interoperability significant hardship application and does not meet the 
sufficient case minimum for cost measures then the weights of Promoting 
Interoperability and cost performance categories are redistributed to 
quality

[[Page 35951]]

and the quality performance category weight would be 85 percent.)
    With a weight of 85 percent, a small practice bonus of 3 points 
added to the quality performance category will result in 4.25 bonus 
points added to the final score for clinicians in small practices.\29\ 
We believe this is appropriate because it is similar to the impact of 
the small practice bonus we finalized for the 2020 MIPS payment year (5 
points added to the final score). While we recognize that the impact of 
the small practice bonus for MIPS eligible clinicians in small 
practices who do not receive reweighting for the cost and/or Promoting 
Interoperability performance categories will be less than 4.25 points 
added to the final score, we believe a consistent approach is 
preferable for simplicity, and we do not believe that a larger bonus is 
appropriate as that could potentially inflate the quality performance 
category score and the final score and mask poor performance.
---------------------------------------------------------------------------

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

(ix) Incentives To Report High-Priority Measures
    In the CY 2017 Quality Payment Program final rule, we established a 
cap on high-priority measure bonus points for the first 2 years of MIPS 
at 10 percent of the denominator (total possible measure achievement 
points the MIPS eligible clinician could receive in the quality 
performance category) of the quality performance category (81 FR 
77294). As part of our proposed technical updates to Sec.  
414.1380(b)(1) discussed in section III.H.3.i.(1)(b) of this proposed 
rule, our previously established policy on incentives to report high-
priority measures is now referenced at Sec.  414.1380(b)(1)(v)(A). We 
are proposing to maintain the cap on measure bonus points for reporting 
high-priority measures for the 2021 MIPS payment year, and to amend 
Sec.  414.1380(b)(1)(v)(A)(1)(ii), accordingly.
    We established the scoring policies for high-priority measure bonus 
points in the CY 2017 Quality Payment Program final rule (81 FR 77293). 
We noted that, in addition to the required measures, CMS Web Interface 
reporters may also report the CAHPS for MIPS survey and receive measure 
bonus points for submitting that measure (81 FR 77293). We refer 
readers to Sec.  414.1380(b)(1)(v)(A) for more details on the high-
priority measure bonus points scoring policies.
    For the 2021 MIPS payment year, we propose to modify the policies 
finalized in the CY 2017 Quality Payment Program final rule (and amend 
Sec.  414.1380(b)(1)(v)(A) accordingly) to discontinue awarding measure 
bonus points to CMS Web Interface reporters for reporting high-priority 
measures. As we continue to move forward in implementing the MIPS 
program, we no longer believe that it is appropriate to award CMS Web 
Interface reporters measure bonus points to be consistent with other 
policies regarding selection of measures. Based on additional data 
analyses since the first-year policy was implemented, we have found 
that practices that elect to report via CMS Web Interface generally 
perform better than other practices that select other collection types. 
Therefore, the benefit of the bonus points is limited and instead we 
believe will create higher than normal scores. Bonus points were 
created as transition policies which were not meant to continue through 
the life of the program. Measure bonus points are also used to 
encourage the selection of additional high-priority measures. As the 
program matures, we have established other policies related to measures 
selection, such as applying a cap of 7 measure achievement points if a 
clinician selects and submits a measure that has been topped out for 2 
or more years; however, we have excluded CMS Web Interface reporters 
from the topped out policies because reporters have no choice in 
measures. By the same logic, since CMS Web Interface reporters have no 
choice in measures, we do not believe it is appropriate to continue to 
provide additional high-priority measure bonuses for reporting CMS Web 
Interface measures. We note the CMS Web Interface users may still elect 
to report the CAHPS for MIPS survey in addition to the CMS Web 
Interface, and if they do, they would receive the high priority bonus 
points for reporting the survey.
    As part of our move towards fully implementing the high value 
measures as discussed in section III.H.3.h.(2)(b)(iv) of this proposed 
rule, we believe that bonus points for high priority measures for all 
collection types may no longer be needed, and as a result, we intend to 
consider in future rulemaking whether to modify our scoring policy to 
no longer offer high priority bonus points after the 2021 MIPS payment 
year.
(x) Incentives To Use CEHRT To Support Quality Performance Category 
Submissions
    Section 1848(q)(5)(B)(ii) of the Act requires the Secretary to 
encourage MIPS eligible clinicians to report on applicable quality 
measures through the use of CEHRT. Under Sec.  414.1380(b)(1)(xv), 1 
bonus point is available for each quality measure submitted with end-
to-end electronic reporting, under certain criteria. As part of our 
proposed technical updates to Sec.  414.1380(b)(1) discussed in section 
III.H.3.i.(1)(b) of this proposed rule, our previously established 
electronic end-to-end reporting bonus point scoring policy is now 
referenced at Sec.  414.1380(b)(1)(v)(B).
    We are proposing to maintain the cap on measure bonus points for 
reporting high-priority measures for the 2021 MIPS payment year. We 
also propose to continue to assign bonus points for end-to-end 
electronic reporting for the 2021 MIPS payment year, as we have seen 
that this policy encourages electronic reporting. We propose to amend 
Sec.  414.1380(b)(1)(v)(B) accordingly.
    We also are proposing to modify our end-to-end reporting bonus 
point scoring policy based on the proposed changes to the submission 
terminology discussed in section III.H.3.h.(1)(b) of this proposed 
rule. We propose that the end-to-end reporting bonus can only apply to 
the subset of data submitted by direct, log in and upload, and CMS Web 
Interface that meet the criteria finalized in the CY 2017 Quality 
Payment Program final rule (81 FR 77297 through 77298). However, the 
end-to-end reporting bonus would not be applied to the claims 
submission type because it does not meet the criteria discussed above. 
This is not a policy change but rather a clarification of our current 
process in light of the proposed terminology changes.
    As discussed in section III.H.3.i.(1)(b)(x) of this proposed rule, 
we believe that in the future bonus points for end-to-end reporting for 
all submission types will no longer be needed as we move towards fully 
implementing the program, and as a result we intend to consider in 
future rulemaking modifying our scoring policy to no longer offer end-
to-end reporting bonus points after the 2021 MIPS payment year. 
Consistent with the section 1848(q)(5)(B)(ii) of the Act, which 
requires the Secretary to encourage the use of CEHRT for quality 
reporting, we will continue to be committed to ways that we can 
incentivize and encourage these reporting methods. We invite comment on 
other ways that we can encourage the use of CEHRT for quality 
reporting.

[[Page 35952]]

(xi) Calculating Total Measure Achievement and Measure Bonus Points
(A) Calculating Total Measure Achievement and Measure Bonus Points for 
Non-CMS Web Interface Reporters
    In the CY 2017 and 2018 Quality Payment Program final rules (81 FR 
77300, and 82 FR 53733 through 53736, respectively), we established the 
policy for calculating total measure achievement and measure bonus 
points for Non-CMS Web Interface reporters. We refer readers to Sec.  
414.1380(b)(1) for more details on these policies.
    We are not proposing any changes to the policy for scoring 
submitted measures collected across multiple collection types; however, 
we provide a summary of how this policy will be scored using our new 
terminology. We note that CMS Web Interface and facility-based 
measurement each have a comprehensive set of measures that meet the 
proposed MIPS category requirements. As a result, we did not combine 
CMS Web Interface measures or facility-based measurement with other 
ways groups can be scored for data submitted for MIPS (other than CAHPS 
for MIPS, which can be submitted in conjunction with the CMS Web 
Interface). We refer readers to section III.H.3.i.(1)(d) of this 
proposed rule for a description of our policies on facility-based 
measurement.
    Although we have established a policy to account for scoring in 
circumstances when the same measure is collected via multiple 
collection types, we anticipate that this will be a rare circumstance 
and do not encourage clinicians to submit the same measure collected 
via multiple collection types. Table 48 is included in this proposed 
rule for illustrative purposes and clarity due to the changes in 
terminology discussed in section III.H.3.h.(1)(b) of this proposed 
rule. For further discussion of this example, we refer readers to the 
CY 2018 Quality Payment Program final rule (82 FR 53734).
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    We do not propose any changes to our policy regarding scoring 
measure achievement points and bonus points when using multiple 
collection types for non-Web Interface MIPS eligible clinicians in the 
quality performance category for the 2019 MIPS performance period.
(B) Calculating Total Measure Achievement and Measure Bonus Points for 
CMS Web Interface Reporters
    In the CY 2017 and 2018 Quality Payment Program final rules (81 FR 
77302 through 77306, and 82 FR 53736 through 82 FR 53737, 
respectively), we finalized the scoring policies for CMS Web Interface 
reporters. As part of our proposed technical updates to Sec.  
414.1380(b)(1) discussed in section III.H.3.i.(1)(b) of this proposed 
rule, our previously established policies for CMS Web Interface 
reporters are now referenced at Sec.  414.1380(b)(1)(i)(A)(2)(i) and 
(b)(1)(v)(A).
(xii) Future Approaches to Scoring the Quality Performance Category
    As we discuss in section III.H.3.h.(2)(b)(iv) of this proposed 
rule, we anticipate making changes to the quality performance category 
to reduce burden and increase the value of the measures we are 
collecting. We discussed that existing measures have differing levels 
of value and our approaches for implementing a system where points are 
awarded based on the value of the measure. Should we adopt these 
approaches, we anticipate needing to modify our scoring approaches 
accordingly. In addition, we have received stakeholder feedback asking 
us to simplify scoring for the quality performance category. Therefore, 
we are seeking comment on the following approaches to scoring that we 
may consider in future rulemaking and whether these approaches move the 
clinicians towards reporting high value measures and more accurate 
performance measurement.
    One option for simplification is restructuring the quality 
requirements with a pre-determined denominator, for example, 50 points, 
but no specific requirements regarding the number of measures that must 
be submitted. Further, we would categorize MIPS and QCDR measures by 
value, because we recognize that not all measures are created equal. We 
seek to ensure that the collection and submission of data is valuable 
to clinicians and worth the cost and burden of collection of 
information. A system to classify measures as a particular value (for 
example, gold, silver, or bronze) is discussed in section 
III.H.3.h.(2)(b)(iv) of this proposed rule. In this approach, the 
highest tier would include measures that are considered ``gold'' 
standard, such as outcome measures, composite measure, or measures that 
address agency priorities (such as opioids). The CAHPS for MIPS survey, 
which collects patient experience data, may also be considered a high-
value measure. Measures considered in the second tier, or at a 
``silver'' standard, would be process measures that are directly 
related to outcomes and have a good gap in performance (there is no 
high, unwavering performance) and demonstrate room for improvement, or 
topped out outcome measures. Lower value measures, such as standard of 
care process measures or topped out process measures, would have 
scoring caps in place that would reflect the measure's status as a 
``bronze measure.'' In this scenario, we could envision awarding points 
for achievement as follows: up to 15 to 20 points in the top tier; up 
to 10 points in the next tier; and up to 5 points in the lowest tier. 
Similar to the structure of the improvement activities performance 
category, a clinician that chooses a top-tier measure would not have to 
submit as many measures to MIPS. We would still want to ensure the 
submission of high value measures and might include requirements that 
restrict the number of lower tier measures that could be submitted; 
alternatively, we could add a requirement that a certain number of 
higher tier measures would need to be submitted. With this approach, we 
could still incentivize reporting on high-priority measures by 
classifying them as ``gold'' standard measures which would be eligible 
for up to 15 to 20 achievement points.
    Alternatively, we could keep our current approach for the quality 
performance category requiring 6 measures including one outcome 
measure, with every measure worth up to 10 measure achievement points 
in the denominator, but change the minimum number of measure 
achievement points available to vary by the measure tier. For example, 
high-tier measures could qualify for high priority bonus and/or have a 
higher potential floor (for example, 5 measure achievement points 
instead of the floor of 3 measure achievement points for ``gold'' 
standard measures, which would be eligible for up to 10 measure 
achievement points.); whereas low-tier measures could have a lower 
floor (for example, 1 measure achievement point instead of the floor of 
3 measure achievement points for ``bronze standard' measures).
    Taking into consideration the potential future quality performance 
category change, we also believe that removing the validation process 
to determine whether the eligible clinician has measures that are 
available and applicable would simplify the quality performance 
category significantly.

[[Page 35955]]

Several stakeholders expressed their confusion with the validation 
process. A move to sets of measures in the quality performance 
category, potentially with some criteria to define the clinicians for 
whom these measures are applicable, would eliminate the need for a 
validation process for measures that are available and applicable. 
Moving to sets of measures would also enable us to develop more robust 
benchmarks. We also believe that in the next few years, we could remove 
the validation process for measures that are available and applicable 
if we set the denominator at a pre-determined level (as outlined in the 
example above at 50 points) and let clinicians determine the best 
method to achieve 50 points.
    For the 2019 and 2020 MIPS payment years, MIPS eligible clinicians 
and groups who report on QCDR measures that do not have an available 
benchmark based on the baseline or performance period but meet data 
completeness are assigned a score of 3 measure achievement points 
(small practices receive 3 points regardless of whether they meet data 
completeness). Through stakeholder engagement, particularly feedback 
provided by QCDRs who have developed their own measures, we have heard 
that MIPS eligible clinicians are hesitant to report QCDR measures 
without established benchmarks. Eligible clinicians have voiced concern 
on reporting on QCDR measures without benchmarks because they are not 
certain that a benchmark could be calculated and established for the 
MIPS performance period, and they would therefore be limited to a 3-
point score for that QCDR measure. In addition, QCDRs have inquired 
about the possibility of creating QCDR benchmarks. To encourage 
reporting of QCDR measures, we seek comment on an approach to develop 
QCDR measure benchmarks based off historical measure data. This may 
require QDCRs to submit historical data in a form and manner that meets 
benchmarking needs as required by CMS. We anticipate that the 
historical QCDR measure data would need to be submitted at the time of 
self-nomination of the QCDR measure, during the self-nomination period. 
Detailed discussion of the self-nomination period timeline and 
requirements can be found in section III.H.3.k of this proposed rule. 
Our concern with utilizing historical data provided by QCDRs to develop 
benchmarks is whether QCDRs have the capability to filter through their 
historical measure data to extract only data from MIPS eligible 
clinicians and groups prior to submitting the historical data to CMS 
for QCDR measure benchmarking consideration. Furthermore, once the 
historical data is submitted by the QCDR, CMS would analyze the data to 
ensure that it met benchmarking standards prior to it being accepted to 
form a benchmark. However, to perform this analysis CMS may need 
additional data elements such as the sources of the data, data 
completeness, and the collection period. In addition to seeking comment 
on developing QCDR measure benchmarks from historical data, we also 
seek comment as to how our aforementioned concerns may be addressed for 
future rulemaking.
    We also recognize that improving the electronic capture, 
calculation, and reporting of quality measures is also an important 
component of reducing provider burden. We invite comment on how we can 
incorporate incentives for the use of electronic clinical quality 
measurement into the future approaches described under this section, as 
well as other ways to encourage more efficient technology-enabled 
measurement approaches.
    We seek comment on these approaches and other approaches to 
simplify scoring, provide incentives to submit more impactful measures 
that assess outcomes rather than processes, and develop data that can 
show differences in performance and determine clinicians that provide 
high value care.
(xiii) Improvement Scoring for the MIPS Quality Performance Category 
Percent Score
    Section 1848(q)(5)(D)(i) of the Act stipulates that, beginning with 
the second year to which the MIPS applies, if data sufficient to 
measure improvement is available, the improvement of the quality 
performance category score for eligible clinicians should be measured. 
To measure improvement we require a direct comparison of data from one 
Quality Payment Program year to another (82 FR 52740). For more 
descriptions of our current policies, we refer readers to the CY 2018 
Quality Payment Program proposed and final rule (82 FR 53737 to 53747). 
As part of our proposed technical updates to Sec.  414.1380(b)(1) 
discussed in section III.H.3.i.(1)(b) of this proposed rule, our 
previously established improvement scoring policies are now referenced 
at Sec.  414.1380(b)(1)(vi).
    In the CY 2018 Quality Payment Program final rule, we adopted a 
policy that MIPS eligible clinicians must fully participate to receive 
a quality performance category improvement percent score greater than 
zero (82 FR 53743 through 53745). In Sec.  414.1380(b)(1)(vi)(F), we 
determined ``participation'' to mean compliance with Sec.  414.1330 and 
Sec.  414.1340 in the current performance period. We issued a technical 
correction for the CY 2018 Quality Payment Year final rule, replacing 
Sec.  414.1330 with Sec.  414.1335 since Sec.  414.1335 is more 
specific because it discusses the quality performance category 
requirements.
    We finalized at Sec.  414.1380(b)(1)(vi)(C)(4) that we would 
compare the 2018 performance to an assumed 2017 quality performance 
category achievement percent score of 30 percent if a MIPS eligible 
clinician earned a quality performance category score less than or 
equal to 30 percent in the previous year (82 FR 53744 through 53745). 
We propose to continue this policy for the 2019 MIPS performance period 
and amend Sec.  414.1380(b)(1)(vi)(C)(4), accordingly. We propose to 
compare the 2019 performance to an assumed 2018 quality performance 
category achievement percent score of 30 percent.
(xiv) Calculating the Quality Performance Category Percent Score 
Including Achievement and Improvement Points
    In the CY 2017 and CY 2018 Quality Payment Program final rules (81 
FR 77300 and 82 FR 53747 through 53748, respectively), we finalized the 
policies on incorporating the improvement percent score into the 
quality performance category percent score. As part of our proposed 
technical updates to Sec.  414.1380(b)(1) discussed in section 
III.H.3.i.(1)(b) of this proposed rule, our previously established 
policies are now referenced at Sec.  414.1380(b)(1)(vii).
(c) Scoring the Cost Performance Category
(i) Scoring Achievement in the Cost Performance Category
    For a description of the statutory basis and our existing policies 
for scoring achievement in the cost performance category, we refer 
readers to the CY 2017 Quality Payment Program final rule (81 FR 77308 
through 77311) and the CY 2018 Quality Payment Program final rule (82 
FR 53748 through 53749). In the CY 2017 Quality Payment Program final 
rule (81 FR 77308 through 77309), we established that we will determine 
cost measure benchmarks based on cost measure performance during the 
performance period. We also established that at least 20 MIPS eligible 
clinicians or groups must meet the minimum case volume that we specify

[[Page 35956]]

for a cost measure in order for a benchmark to be determined for the 
measure, and that if a benchmark is not determined for a cost measure, 
the measure will not be scored. We propose to codify these final 
policies at Sec.  414.1380(b)(2)(i).
(ii) Scoring Improvement in the Cost Performance Category
    For a description of the statutory basis and our existing policies 
for scoring improvement in the cost performance category, we refer 
readers to the CY 2018 Quality Payment Program final rule (82 FR 53749 
through 53752). Section 51003(a)(1)(B) of the Bipartisan Budget Act of 
2018 modified section 1848(q)(5)(D) of the Act such that the cost 
performance category score shall not take into account the improvement 
of the MIPS eligible clinician for each of the second, third, fourth, 
and fifth years for which the MIPS applies to payments. We do not 
believe this change requires us to remove our existing methodology for 
scoring improvement in the cost performance category (see 82 FR 53749 
through 53752), but it does prohibit us from including an improvement 
component in the cost performance category percent score for each of 
the 2020 through 2023 MIPS payment years. Therefore, we propose to 
revise Sec.  414.1380(b)(2)(iv)(E) to provide that the maximum cost 
improvement score for the 2020, 2021, 2022, and 2023 MIPS payment years 
is zero percentage points. Under our existing policy (82 FR 53751 
through 53752), the maximum cost improvement score for the 2020 MIPS 
payment year is 1 percentage point, but due to the statutory changes 
and under our proposal, the maximum cost improvement score for the 2020 
MIPS payment year would be zero percentage points. We are also 
proposing at Sec.  414.1380(a)(1)(ii) to modify the performance 
standards to reflect that the cost performance category percent score 
will not take into account improvement until the 2024 MIPS payment 
year.
(d) Facility-Based Measures Scoring Option for the 2021 MIPS Payment 
Year for the Quality and Cost Performance Categories
(i) Background
    In the CY 2018 Quality Payment Program final rule, we established a 
facility-based measurement scoring option for clinicians that meet 
certain criteria beginning with the 2019 MIPS performance period/2021 
MIPS payment year (82 FR 53752 through 53767). We originally proposed a 
facility-based measurement scoring option for the 2018 MIPS performance 
period. We did not finalize the policy because we were concerned that 
we would not have the operational ability to inform clinicians early 
enough in the 2018 MIPS performance period to allow them to consider 
the consequences and benefits of participation (82 FR 53755).
(ii) Facility-Based Measurement Applicability
(A) General
    In the CY 2018 Quality Payment Program final rule, we limited 
facility-based reporting to the inpatient hospital in the first year 
for several reasons, including that a more diverse group of clinicians 
(and specialty types) provide services in an inpatient setting than in 
other settings, and that the Hospital Value-Based Purchasing (VBP) 
Program adjusts payment to hospitals in connection with both increases 
and decreases in performance (82 FR 53753 through 53755). We also 
limited measures applicable for facility-based measurement to those 
used in the Hospital VBP Program because the Hospital VBP Program 
compares hospitals on a series of different measures intended to 
capture the breadth of inpatient care in the facility (82 FR 53753). We 
noted that we were open to the consideration of additional facility 
types in the future but recognized that adding a facility type would be 
dependent upon the status of the VBP program applicable to that 
facility, the applicability of measures, and the ability to 
appropriately attribute a clinician to a facility (82 FR 53754). We do 
not propose to add additional facility types for facility-based 
measurement in this proposed rule, but we are interested in potentially 
expanding to other settings in future rulemaking. Therefore, in section 
III.H.3.i.(1)(d)(vii), we outline several issues that would need to be 
resolved in order to expand this option to a wider group of facility-
based clinicians.
(B) Facility-Based Measurement by Individual Clinicians
    In the CY 2018 Quality Payment Program final rule, we established 
individual eligibility criteria for facility-based measurement at Sec.  
414.1380(e)(2)(i). We established that a MIPS eligible clinician who 
furnishes 75 percent or more of his or her covered professional 
services in sites of service identified by the POS codes used in the 
HIPAA standard transaction as an inpatient hospital or emergency room 
based on claims for a period prior to the performance period as 
specified by CMS (82 FR 53756 through 53757) is eligible as an 
individual for facility-based measurement. We had noted, as a part of 
our proposal summary, that we would use the definition of professional 
services in section 1848(k)(3)(A) of the Act in applying this standard 
(82 FR 53756). For purposes of determining eligibility for facility-
based measurement, we discussed CMS using data from the period between 
September 1 of the calendar year, 2 years preceding the MIPS 
performance period, through August 31 of the calendar year preceding 
the MIPS performance period, with a 30-day claims run out but did not 
finalize that as part of the applicable regulation (82 FR 53756 through 
53757). Because we are using the quality measures associated with the 
inpatient hospital to determine the MIPS quality and cost performance 
category score, we wanted to ensure that eligible clinicians 
contributed to care in that setting during that time period.
    We indicated that CMS will use POS code 21 (inpatient) and POS code 
23 (emergency department) for this purpose (82 FR 53756). Commenters on 
our proposal (as summarized in the CY 2018 Quality Payment Program 
final rule (82 FR 53756 through 53757)) expressed concern that adopting 
the definition that we did for facility-based clinicians would limit 
the number of clinicians who would be eligible. In particular, 
commenters were concerned about the omission of the on-campus 
outpatient hospital POS code (POS code 22) for observation services, 
which are similar to and often take place in the same physical location 
as inpatient services. In the CY 2018 Quality Payment Program final 
rule, we sought comment on ways to identify clinicians who have a 
significant presence within the inpatient setting, and how to address 
concerns about including POS code 22 in this definition (82 FR 57357). 
A few commenters that responded again suggested that CMS add POS code 
22. In addition, a few commenters suggested that several other POS can 
be included, including ambulatory surgical centers, IRFs, and SNFs.
    We are proposing to modify our determination of a facility-based 
individual at Sec.  414.1380(e)(2)(i) in four ways. First, we propose 
to add on-campus outpatient hospital (as identified in the POS code in 
the HIPAA standard transaction, that is, POS code 22) to the settings 
that determine whether a clinician is facility-based. Second, we 
propose that a clinician must have at least a single service billed 
with the POS code used for the inpatient hospital or emergency room. 
Third, we propose that, if we are unable to identify a facility with a 
VBP score

[[Page 35957]]

to attribute a clinician's performance, that clinician is not eligible 
for facility-based measurement. Fourth, we propose to align the time 
period for determining eligibility for facility-based measurement with 
changes to the dates used to determine MIPS eligibility and special 
status detailed in section III.H.3.b. of this rule. We explain these 
four proposals below. We believe that these proposals will further 
expand the opportunity for facility-based measurement and eliminate 
issues associated with the provision of observation services while 
still restricting eligibility to those who work in an inpatient 
setting.
    First, we propose to add the on-campus outpatient hospital (POS 
code 22) to the list of sites of service used to determine eligibility 
for facility-based measurement. We agree with commenters that limiting 
the eligibility to our current definition may prevent some clinicians 
who are largely hospital-based from being eligible. However, expanding 
eligibility without taking into account the relationship between the 
clinician and the facility and facility's performance could result in 
unfairly attributing to a clinician performance for which the clinician 
is not responsible or has little to no role in improving. We do believe 
that a significant provision of services in the on-campus outpatient 
hospital are reflected in the quality captured by the Hospital VBP 
Program. For example, patients in observation status are typically 
treated by the same staff and clinicians as those who meet the 
requirements for inpatient status. While there are some clinical 
differences that may result in a patient having observation status, we 
believe that the quality of care provided to these patients in this 
same setting would be comparable, reflecting the overall healthcare 
system at that particular location. Therefore, we are convinced that a 
sufficient nexus exists for attributing the hospital's VBP performance 
to clinicians that provide services in on-campus outpatient hospital 
settings.
    Second, we propose to require that clinicians bill at least a 
single service with the POS codes for inpatient hospital or the 
emergency room in order to be eligible for facility-based measurement. 
While we generally believe that clinicians who provide services in the 
outpatient hospital can affect the quality of care for inpatients, we 
believe that a clinician who is to be measured according to the 
performance of a hospital should at least have a minimal presence in 
the inpatient or emergency room setting. We remain concerned about 
including clinicians who provide at least 75 percent of their services 
at on-campus outpatient hospitals (with POS code 22) when such 
clinicians exclusively provide outpatient services that are unrelated 
to inpatient hospital service. For example, a dermatologist who 
provides office-based services in a hospital-owned clinic but who never 
admits or treats patient within the inpatient or emergency room setting 
does not meaningfully contribute to the quality of care for patients 
measured under the Hospital VBP Program.
    We considered different ways to best identify those who contribute 
to the quality of care in the inpatient setting while keeping the 
facility-based scoring option as simple as possible. We considered 
separately measuring the HCPCS codes for observation services, but 
believe that such a measurement may not fairly consider services 
provided by clinicians for whom observations services may be embedded 
in a global code for a procedure rather than billed as a separate 
observation service. We also considered requiring a clinician to 
provide a certain percentage of services with the inpatient hospital 
POS. However, we have not identified a threshold (other the one claim 
threshold we proposed here) that would more meaningfully differentiate 
clinicians who provide services with the outpatient hospital POS code 
but do not contribute to the services that would be measured under the 
Hospital VBP Program. We believe it is important to ensure that the 
program rules are clear and easily applied to clinicians, so as to both 
avoid confusion on program participation requirements and to meet 
overall agency goals to increase transparency in the agency's 
activities. We believe that using a single service as the threshold 
provides a simple, bright-line to differentiate those who never provide 
inpatient services from clinicians that do provide inpatient services, 
as well as outpatient services. We also believe this will limit the 
opportunity for clinicians who exclusively practice in the outpatient 
setting to be measured on the VBP performance of an unrelated hospital. 
We recognize this requirement of one service with the inpatient or 
emergency department POS may not demonstrate a significant presence in 
a particular facility, and we seek comment on whether a better 
threshold could be used to identify those who are contributing to the 
quality of care for patients in the inpatient setting without creating 
barriers to eligibility for facility-based measurement.
    Our rationale and reasoning for these first two proposals is based 
in large part on our analysis of the previously finalized policy for 
eligibility for the facility-based measurement scoring option. Using 
claims data, we identified all clinicians that would be MIPS eligible 
as either an individual or group, and identified the POS codes 
submitted for physician fee schedule services provided by those 
clinicians. We then modeled the existing final policy based on 
inpatient and ER services. We determined that while almost all ER 
physicians would be scored under facility-based measurement, a 
relatively small percentage of clinicians in other specialties, even 
those which we would expect to have significant presence in the 
hospital, would be eligible for the facility-based measurement scoring 
option. For example, only 13.45 percent of anesthesiologists would be 
eligible for the facility-based measurement scoring option under our 
existing policy. Adding the on-campus outpatient hospital POS code 
substantially increases eligibility for the facility-based measurement 
scoring option, even after we adjust for requiring one service with the 
inpatient or emergency department POS. By adopting our newly proposed 
policy, 72.55 percent of anesthesiologists would be eligible. However, 
this proposed new policy would not substantially increase the number of 
clinicians eligible for the facility-based measurement scoring option 
who, based on specialty identification, may not have a significant 
presence in the hospital. For example, our newly proposed policy would 
increase the percentage of family physicians eligible for the facility-
based measurement scoring option from 11.34 percent to 13.86 percent, 
which is still a very small percentage of those clinicians.
    Our third proposal is to add a new criterion (To be codified at 
Sec.  414.1380(e)(2)(i)(C)): To be eligible for facility-based 
measurement, we must be able to attribute a clinician to a particular 
facility that has a VBP score. For facility-based measurement to be 
applicable, we must be able to attribute a clinician to a facility with 
a VBP score. Based on our definition of facility-based measurement, 
this means a clinician must be associated with a hospital with a 
Hospital VBP Program Total Performance Score. We are concerned that our 
proposed expansion of eligibility for facility-based measurement could 
increase the number of clinicians who are eligible for facility-based 
measurement but whom we are unable to attribute to a particular 
facility

[[Page 35958]]

that has a VBP score. In the CY 2018 Quality Payment Program final 
rule, we noted that some hospitals do not have a Hospital VBP Program 
Total Performance Score that could be used to determine a MIPS quality 
and cost performance category score, such as hospitals in the state of 
Maryland (82 FR 53766). Hence, clinicians associated with those 
hospitals would not be able to use facility-based measurement but could 
report quality measures through another method and have cost measures 
calculated if applicable. We believe a similar result should apply if 
we cannot attribute a clinician identified as facility-based to a 
specific facility. We believe that such a situation would be relatively 
rare. Those clinicians who are identified as facility-based but for 
whom we are unable to attribute to a hospital must participate in MIPS 
quality reporting through another method, or they will receive a score 
of zero in the quality performance category. We therefore propose to 
add the requirement to Sec.  414.1380(e)(2)(i) that a clinician must be 
able to be attributed to a particular facility with a VBP score under 
the methodology specified in Sec.  414.1380(e)(5) to meet eligibility 
for facility-based measurement. The cross-reference to paragraph (e)(5) 
is to the methodology for determining the applicable facility score 
that would be used. Our proposed new regulatory text at Sec.  
414.1380(e)(2)(i)(C) addresses both attribution to a facility and the 
need for that facility to have a VBP score by conditioning eligibility 
for facility-based scoring for an individual clinician on the clinician 
being attributed under the methodology in paragraph (e)(5) to a 
facility with a VBP score.
    Fourth, we propose to change the dates of determining eligibility 
for facility-based measurement. In section III.M.3.b. of this rule, we 
propose to modify the dates of the MIPS determination period that would 
provide eligibility determination for small practice size, non-patient 
facing, low-volume threshold, ASC, hospital-based, and facility-based 
determination periods. To align this regulation with these other 
determination periods, we propose that CMS will use data from the 
initial 12-month segment beginning on October 1 of the calendar year 2 
years prior to the applicable performance period and ending on 
September 30 of the calendar year preceding the applicable performance 
period with a 30-day claims run out in determining eligibility for 
facility-based measurement.
(C) Facility-Based Measurement by Group
    In the CY 2018 Quality Payment Program final rule, we finalized at 
Sec.  414.1380(e)(2)(ii) that a MIPS eligible clinician is eligible for 
facility-based measurement under MIPS if they are determined to be 
facility-based as part of a group (82 FR 53757). We established at 
Sec.  414.1380(e)(2)(ii) that a facility-based group is a group in 
which 75 percent or more of its eligible clinician NPIs billing under 
the group's TIN meet the requirements at Sec.  414.1380(e)(2)(i) (82 FR 
53758). We do not propose any changes to the determination of a 
facility-based group but acknowledge that our proposal to change how 
individual clinicians are determined to be eligible for facility-based 
measurement will necessarily have a practical impact for practice 
groups. For more of the statutory background and descriptions of our 
current policies on determining a facility-based group, we refer 
readers to the CY 2018 Quality Payment Program final rule (82 FR 53757 
through 53758).
(iii) Facility Attribution for Facility-Based Measurement
    In the CY 2018 Quality Payment Program final rule, we finalized at 
Sec.  414.1380(e)(5) a method to identify the hospital whose scores 
would be associated with a MIPS eligible clinician or group that elects 
facility-based measurement scoring (82 FR 53759). Although we did not 
specifically address the issue of how facility-based groups would be 
assigned to a facility (for purposes of attributing facility 
performance to the group) in the preamble of the CY 2018 Quality 
Payment Program proposed rule, our proposed regulation at Sec.  
414.380(e)(5) did apply the same standard to individuals and groups. We 
believe that this provided sufficient notice of the policy; 
nevertheless, we indicated we would address this issue as part of the 
next Quality Payment Program rulemaking cycle (82 FR 53759). Therefore, 
we are revisiting facility-based attribution for individuals and groups 
in this proposed rule.
    Under the current regulation text Sec.  414.1380(e)(5), a facility-
based clinician or group receives a score under the facility-based 
measurement scoring standard derived from the VBP score for the 
facility at which the clinician or group provided services to the most 
Medicare beneficiaries during the year claims are drawn (that is, the 
12-month period described in paragraph (e)(2)). If an equal number of 
Medicare beneficiaries are treated at more than one facility, then we 
will use the VBP score for the highest-scoring facility (82 FR 53759 
through 53760). For more of the statutory background and descriptions 
of our current policies for attributing a facility to a MIPS eligible 
clinician, we refer readers to the CY 2018 Quality Payment Program 
final (82 FR 53759 through 53760).
    In considering the issue of facility attribution for a facility-
based group, we believe that a change to facility-based attribution is 
appropriate to better align the policy with the determination of a 
facility-based group at Sec.  414.1380(e)(2)(ii). A facility-based 
group is one in which 75 percent or more of the eligible clinician NPIs 
billing under the group's TIN are eligible for facility-based 
measurement as individuals. Additionally, under the current regulation, 
the VBP score for the highest scoring facility would be used in the 
case of a tie among the number of facilities at which the group 
provided services to Medicare beneficiaries. We propose to revise Sec.  
414.1380(e)(5) to differentiate how a facility-based clinician or group 
receives a score based on whether they participate as a clinician or a 
group.
    We propose to remove ``or group'' from Sec.  414.1380(e)(5) and 
redesignate that paragraph as (e)(5)(i) so that it only applies to 
individual MIPS eligible clinicians. Under our proposal, newly 
redesignated paragraph (e)(5)(i) retains the rule for facility 
attribution for an individual MIPS eligible clinician as finalized in 
the CY 2018 Quality Payment Program final rule; we are also proposing a 
few minor edits to the paragraph for grammar and to improve the 
sentence flow. We also propose to add a new paragraph (e)(5)(ii) to 
provide that a facility-based group receives a score under the 
facility-based measurement scoring standard derived from the VBP score 
for the facility at which the plurality of clinicians identified as 
facility-based would have had their score determined under the 
methodology described in Sec.  414.1380(e)(5)(i) if the clinicians had 
been scored under facility-based measurement as individuals. We make 
this proposal because we wish to emphasize the connection between an 
individual clinician and a facility. We believe that using the 
plurality of clinicians reinforces the connection between an individual 
clinician and facility and is more easily understandable for larger 
groups.
(iv) No Election of Facility-Based Measurement
    In the CY 2018 Quality Payment Program final rule, we did not 
finalize

[[Page 35959]]

our proposal for how individual MIPS eligible clinicians or groups who 
wish to have their quality and cost performance category scores 
determined based on a facility's performance would elect to do so 
through an attestation (82 FR 53760). We did finalize, and reflect in 
the introductory text at Sec.  414.1380(e), that an individual 
clinician or group would elect to use a facility-based score. The 
proposal had specified that such clinicians or groups would be required 
to submit their election during the data submission period through the 
attestation submission mechanism established for the improvement 
activities and the Promoting Interoperability performance categories 
(82 FR 53760). An alternative approach, which likewise was not 
finalized, did not require an election process, but instead would have 
automatically applied a facility-based measurement to MIPS eligible 
clinicians and groups who are eligible for facility-based measurement, 
if such an application were technically feasible (82 FR 53760). We 
noted in the CY 2018 Quality Payment Program final rule that we would 
examine both the attestation process we proposed and the alternative 
opt-out process, and work with stakeholders to identify a new proposal 
in future rulemaking (82 FR 53760). We indicated our interest in a 
process that would impose less burden on clinicians than an attestation 
requirement.
    In the CY 2018 Quality Payment Program final rule, we requested 
further comment on the propriety of automatically assigning a clinician 
or group a score under facility-based measurement, but where CMS would 
notify and give the clinician the opportunity to opt-out of facility-
based measurement (82 FR 53760). We subsequently received comments both 
in favor of and opposed to an opt-out approach. A few commenters 
supported the opt-out approach because it would reduce administrative 
burden on behalf of the clinician. A few commenters expressed concern 
that an opt-out process could result in clinicians unintentionally 
being measured on the basis of a facility. A few commenters expressed 
concern that an automatic assignment of a score would provide an unfair 
advantage for facility-based clinicians.
    After further considering the advantages and disadvantages of an 
opt-in or an opt-out process, we are proposing a modified policy that 
does not require an election process. Instead, we propose to 
automatically apply facility-based measurement to MIPS eligible 
clinicians and groups who are eligible for facility-based measurement 
and who would benefit by having a higher combined quality and cost 
performance category score. That is, if the MIPS eligible clinician or 
group is eligible for facility-based measurement, we would calculate a 
combined quality and cost performance category score. We propose to use 
the facility-based score to determine the MIPS quality and cost 
performance category scores, unless we receive another submission of 
quality data for or on behalf of that clinician or group and the 
combined quality and cost performance category score for the other 
submission results in a higher combined quality and cost performance 
score. If the other submission has a higher combined quality and cost 
performance score, then we would not apply the facility-based 
performance scores for either the quality or cost performance 
categories. Under our proposal, the combined score for the quality and 
cost performance categories would determine the scores to be used for 
both the quality and cost performance categories, for both individual 
clinicians and for groups that meet the requirements of paragraph 
(e)(2). We do not propose to adopt a formal opt-out process because, 
under our proposal, the higher of the quality and cost performance 
scores available or possible for the clinician or clinician group would 
be used, which would only benefit the clinician or group. We have a 
strong commitment to reducing burden as part of the Quality Payment 
Program, and we believe that requiring a clinician or group to elect a 
measurement process (or to opt-out of a measurement process) based on 
facility performance would add unnecessary burden.
    In MIPS, we score clinicians as individuals unless they submit data 
as a group. We believe that same policy should apply to facility-based 
measurement, even though there are no submission requirements for the 
quality performance category for individuals under facility-based 
measurement. Therefore, we propose to revise Sec.  414.1380(e)(4) to 
state that there are no submission requirements for individual 
clinicians in facility-based measurement but a group must submit data 
in the improvement activities or Promoting Interoperability performance 
categories in order to be measured as a group under facility-based 
measurement. If a group does not submit improvement activities or 
Promoting Interoperability measures, then we would apply facility-based 
measurement to the individual clinicians and such clinicians would not 
be scored as a group. In the case of virtual groups, MIPS eligible 
clinicians would have formed virtual groups prior to the MIPS 
performance period; as a result, virtual groups eligible for facility-
based measurement would always be measured as a virtual group. While we 
could calculate a score for a TIN without the submission of data by the 
TIN, we would be uncertain if the clinicians within that group wished 
to be measured as a group without an active submission (in other words, 
if the group did not submit data as a group). Submission of data on the 
improvement activities or Promoting Interoperability measures indicates 
an intent and desire to be scored as a group. Hence, we believe that 
using the choice to submit data as a group to identify a group in the 
context of facility-based scoring will preserve choices made by 
clinicians and groups while avoiding the burden of an election process 
to be scored as a group solely for the purpose of facility-based 
scoring. We solicit comment specifically on this proposal and other 
means to achieve the same ends.
    In the CY 2018 Quality Payment Program final rule, we established 
that if a clinician or group elects facility-based measurement but also 
submits MIPS quality data, then the clinician or group would be 
measured on the method that results in the higher quality score (82 FR 
53767). We propose to adopt this same scoring principle in conjunction 
with our proposal not to use (or require) an election process. 
Therefore, we propose at Sec.  414.1380(e)(6)(vi) that the MIPS quality 
and cost score for clinicians and groups eligible for facility-based 
measurement will be based on the facility-based measurement scoring 
methodology described in Sec.  414.1380(e)(6) unless the clinician or 
group receives a higher combined score for the MIPS quality and cost 
performance categories through data submitted to CMS for MIPS. Because 
Sec.  414.1380(d) states that MIPS eligible clinicians in MIPS APMs are 
scored under the MIPS APM scoring standard described at Sec.  414.1370, 
those clinicians would not be scored using facility-based measurement.
    We also propose conforming changes in two other sections of 
regulatory text. We propose to revise the introductory text at Sec.  
414.1380(e) to remove ``elect to,'' and therefore, reflect that 
clinicians and groups who are determined to be facility-based will 
receive MIPS quality and cost performance categories under the 
methodology in paragraph (e). We note that because we do not require 
clinicians to opt-in into facility-based measurement, there may be 
clinicians that will continue to submit data via other methods. Hence, 
these clinicians

[[Page 35960]]

and groups are not prohibited from submitting quality measures to CMS 
for purposes of MIPS; if higher combined quality and cost scores are 
achieved using data submitted to CMS for purposes of MIPS, then we will 
use that result. We also propose to revise Sec.  414.1380(e)(4) and 
(e)(6)(v)(A) to reflect that facility-based measurement does not 
require election and to replace the phrase ``clinicians that elect 
facility-based measurement'' with ``clinicians and groups scored under 
facility-based measurement.''
(v) Facility-Based Measures
(A) Background
    Section 1848(q)(2)(C)(ii) of the Act provides that the Secretary 
may use measures used for payment systems other than for physicians, 
such as measures for inpatient hospitals, for purposes of the quality 
and cost performance categories. However, the Secretary may not use 
measures for hospital outpatient departments, except in the case of 
items and services furnished by emergency physicians, radiologists, and 
anesthesiologists. In the CY 2018 Quality Payment Program proposed 
rule, we proposed to include for the 2020 MIPS payment year all the 
measures adopted for the FY 2019 Hospital VBP Program on the MIPS list 
of quality measures and cost measures for purposes of facility based 
measurement (82 FR 30125). We noted how these measures meet the 
definition of additional system-based measures provided in section 
1848(q)(2)(C)(ii) of the Act (82 FR 30125). In the CY 2018 Quality 
Payment Program final rule, we did not finalize our proposal that the 
facility-based measures available for the 2018 MIPS performance period 
would be the measures adopted for the FY 2019 Hospital VBP Program; nor 
did we finalize our proposal that, for the 2020 MIPS payment year, 
facility-based individual MIPS eligible clinicians or groups that were 
attributed to a facility would be scored on all measures on which the 
facility is scored via the Hospital VBP Program's Total Performance 
Score methodology (82 FR 53762).
    We did finalize a facility-based measurement scoring standard but 
not the specific instance of using the FY 2019 Hospital VBP Program 
Total Performance Score methodology (82 FR 53755). We expressed our 
belief that the policy approach of using all measures from the Hospital 
VBP program is appropriate; nevertheless, because we did not finalize 
the facility-based measurement scoring option for the 2018 MIPS 
performance period/2021 MIPS payment year, it was not appropriate to 
adopt these policies at that time (82 FR 53762 through 53763). We noted 
that we intended to propose measures that would be available for 
facility-based measurement for the 2019 MIPS performance period/2021 
MIPS payment year in future rulemaking (82 FR 53763).
    For a detailed description of the policies proposed and finalized, 
we refer readers to the CY 2018 Quality Payment Program final rule (82 
FR 53761 through 53763).
(B) Measures in Facility-Based Scoring
    We continue to believe it is appropriate to adopt all the measures 
for the Hospital VBP Program into MIPS for purposes of facility-based 
scoring; these Hospital VBP Program measures meet the definition of 
additional system-based measures provided in section 1848(q)(2)(C)(ii) 
of the Act. We also believe it is appropriate to adopt the performance 
periods for the measures, which generally are consistent with the dates 
that we use to determine eligibility for facility-based measurement.
    Therefore, beginning with the 2019 MIPS performance period, we 
propose at Sec.  414.1380(e)(1)(i) to adopt for facility-based 
measurement, the measure set that we finalize for the fiscal year 
Hospital VBP program for which payment begins during the applicable 
MIPS performance period. For example, for the 2019 MIPS performance 
period, which runs on the 2019 calendar year, we propose to adopt the 
FY 2020 Hospital VBP Program measure set, for which payment begins on 
October 1, 2019. The performance period for these measures varies but 
performance ends in 2018 for all measures.
    We also propose at Sec.  414.1380(e)(1)(ii) that, starting with the 
2021 MIPS payment year, the scoring methodology applicable for MIPS 
eligible clinicians scored with facility-based measurement is the Total 
Performance Score methodology adopted for the Hospital VBP Program, for 
the fiscal year for which payment begins during the applicable MIPS 
performance period. Therefore, for the 2021 MIPS payment year, the 
Total Performance Score methodology for 2019 would apply for facility-
based scoring. We note that this approach of adopting all the measures 
in the Hospital VBP program can be applied to other VBP programs in the 
future, should we decide to expand facility-based measurement to 
settings other than hospitals in the future.
    In the CY 2018 Quality Payment Program final rule we also 
established at Sec.  414.1380(e)(6)(i) that the available quality and 
cost measures for facility-based measurement are those adopted under 
the VBP program of the facility for the year specified. We established 
at Sec.  414.1380(e)(6)(ii) that we will use the benchmarks adopted 
under the VBP program of the facility program for the year specified 
(82 FR 53763 through 53764). We noted that we would determine the 
particular VBP program to be used for facility-based measurement in 
future rulemaking but would routinely use the benchmarks associated 
with that program (82 FR 53764). Likewise, at Sec.  
414.1380(e)(6)(iii), we established that the performance period for 
facility-based measurement is the performance period for the measures 
adopted under the VBP program of the facility program for the year 
specified (82 FR 53755). We noted that these provisions referred to the 
general parameters of our method of facility-based measurement and that 
we would address specific programs and years in future rulemaking (82 
FR 53763). We now propose regulation for these three provisions to 
specify that the measures, performance period, and benchmark period for 
facility-based measurement are the measures, performance period, and 
benchmark period established for the VBP program used to determine the 
score as described in Sec.  414.1380(e)(1). As an example, for the 2019 
MIPS performance period and 2021 MIPS payment year, the measures used 
would be those for the FY 2019 Hospital VBP program along with the 
associated benchmarks and performance periods.
(C) Measures for MIPS 2019 Performance Period/2021 MIPS Payment Year
    For informational purposes, we are providing a list of measures 
included in the FY 2020 Hospital VBP Program measures in determining 
the quality and cost performance category scores for the 2019 MIPS 
performance period/2021 MIPS payment year. The FY 2020 Hospital VBP 
Program has adopted 12 measures covering 4 domains (83 FR 20412 through 
13). The performance period for measures in the Hospital VBP Program 
varies depending on the measure, and some measures include multi-year 
performance periods. We include the FY 2020 Hospital VBP Program 
measures in Table 49. We note that these measures are determined 
through separate rulemaking (82 FR 38244). As noted in section 
III.H.3.i.(1)(d)(v) of this proposed rule, we would adopt these 
measures, benchmarks, and performance periods for the purposes of 
facility-based measurement.

[[Page 35961]]



                                                     Table 49--FY 2020 Hospital VBP Program Measures
--------------------------------------------------------------------------------------------------------------------------------------------------------
                Short name                        Domain/measure name             NQF No.                         Performance period
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                         Person and Community Engagement Domain
--------------------------------------------------------------------------------------------------------------------------------------------------------
HCAHPS...................................  Hospital Consumer Assessment of       0166 (0228)  January 1, 2018-December 31, 2018.
                                            Healthcare Providers and Systems
                                            (HCAHPS) (including Care
                                            Transition Measure).
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               Clinical Outcomes Domain *
--------------------------------------------------------------------------------------------------------------------------------------------------------
MORT-30-AMI..............................  Hospital 30-Day, All-Cause, Risk-            0230  July 1, 2015-June 30, 2018.
                                            Standardized Mortality Rate
                                            (RSMR) Following Acute
                                            Myocardial Infarction (AMI)
                                            Hospitalization.
MORT-30-HF...............................  Hospital 30-Day, All-Cause, Risk-            0229  July 1, 2015-June 30, 2018.
                                            Standardized Mortality Rate
                                            (RSMR) Following Heart Failure
                                            (HF) Hospitalization.
MORT-30-PN...............................  Hospital 30-Day, All-Cause, Risk-            0468  July 1, 2015-June 30, 2018.
                                            Standardized Mortality Rate
                                            (RSMR) Following Pneumonia
                                            Hospitalization.
THA/TKA..................................  Hospital-Level Risk-Standardized             1550  July 1, 2015-June 30, 2018.
                                            Complication Rate (RSCR)
                                            Following Elective Primary Total
                                            Hip Arthroplasty (THA) and/or
                                            Total Knee Arthroplasty (TKA).
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Safety Domain **
--------------------------------------------------------------------------------------------------------------------------------------------------------
CAUTI....................................  National Healthcare Safety                   0138  January 1, 2018-December 31, 2018.
                                            Network (NHSN) Catheter-
                                            Associated Urinary Tract
                                            Infection (CAUTI) Outcome
                                            Measure.
CLABSI...................................  National Healthcare Safety                   0139  January 1, 2018-December 31, 2018.
                                            Network (NHSN) Central Line-
                                            Associated Bloodstream Infection
                                            (CLABSI) Outcome Measure.
Colon and Abdominal Hysterectomy SSI.....  American College of Surgeons--               0753  January 1, 2018-December 31, 2018.
                                            Centers for Disease Control and
                                            Prevention (ACS-CDC) Harmonized
                                            Procedure Specific Surgical Site
                                            Infection (SSI) Outcome Measure.
MRSA Bacteremia..........................  National Healthcare Safety                   1716  January 1, 2018-December 31, 2018.
                                            Network (NHSN) Facility-wide
                                            Inpatient Hospital-onset
                                            Methicillin-resistant
                                            Staphylococcus aureus (MRSA)
                                            Bacteremia Outcome Measure.
CDI......................................  National Healthcare Safety                   1717  January 1, 2018-December 31, 2018.
                                            Network (NHSN) Facility-wide
                                            Inpatient Hospital-onset
                                            Clostridium difficile Infection
                                            (CDI) Outcome Measure.
PC-01....................................  Elective Delivery................            0469  January 1, 2018-December 31, 2018.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                          Efficiency and Cost Reduction Domain
--------------------------------------------------------------------------------------------------------------------------------------------------------
MSPB.....................................  Payment-Standardized Medicare                2158  January 1, 2018-December 31, 2018.
                                            Spending Per Beneficiary (MSPB).
--------------------------------------------------------------------------------------------------------------------------------------------------------

(vi) Scoring Facility-Based Measurement
(A) Scoring Achievement in Facility-Based Measurement
    In the CY 2018 Quality Payment Program final rule, we adopted 
certain scoring policies for clinicians and groups in facility-based 
measurement. We established at Sec.  414.1380(e)(6)(iv) and (v) that 
the quality and cost performance category percent scores would be 
established by determining the percentile performance of the facility 
in the VBP purchasing program for the specified year, then awarding 
scores associated with that same percentile performance in the MIPS 
quality and cost performance categories for those MIPS eligible 
clinicians who are not scored using facility-based measurement for the 
MIPS payment year (82 FR 53764). We also finalized at Sec.  
414.1380(e)(6)(v)(A) that clinicians scored under facility-based 
measurement would not be scored on other cost measures (82 FR 53767).
    For detailed descriptions of the current policies related to 
scoring achievement in facility-based measurement, we refer readers to 
the CY 2018 Quality Payment Program final rule (82 FR 53763). Because 
we propose in section III.H.3.i.(1)(d)(iv) of this rule to not require 
or allow an opt-in process for facility-based measurement, we propose a 
change to the determination of the quality and cost performance 
category scores. We propose that the quality and cost performance 
category percent scores would be established by determining the 
percentile performance of the facility in the Hospital VBP Program for 
the specified year, then awarding a score associated with that same 
percentile performance in the MIPS quality and cost performance 
categories for those MIPS eligible clinicians who are not eligible to 
be scored under facility-based measurement for the MIPS payment year. 
This proposed change allows for the determination of percentile 
performance independent of those clinicians who would not have their 
quality or cost scores determined until we made the determination of 
their status under facility-based measurement.
(B) Scoring Improvement in Facility-Based Measurement
    In the CY 2018 Quality Payment Program final rule, we finalized 
that we would not give a clinician or group participating in facility-
based measurement the opportunity to earn improvement points based on 
prior performance in the MIPS quality and cost performance categories; 
we noted that the Hospital VBP Program already takes improvement into 
account in determining the score (82 FR 53764 through 53765). We 
propose to add this

[[Page 35962]]

previously finalized policy to regulatory text at Sec.  
414.1380(e)(6)(iv) and (v).
    However, we did not address a policy for a clinician or group who 
participates in facility-based measurement for one performance period, 
and then does not participate in facility-based measurement in a 
subsequent performance period (for example, a clinician who is scored 
using facility-based measurement in the 2019 MIPS performance period 
and is not eligible for facility-based measurement in the 2020 MIPS 
performance period).
    After further considering the issue, we do not believe it is 
possible to assess improvement in the quality performance category for 
those who are measured under facility-based measurement in 1 year and 
then through another method in the following year. Our method of 
assessing and rewarding improvement in the MIPS quality performance 
category separates points awarded for measure performance from those 
received for bonus points (82 FR 53745). Our method of determining the 
quality performance category score using facility-based measurement 
does not allow for the separation of achievement from bonus points. For 
this reason, we propose at Sec.  414.1380(b)(1)(xi)(A)(4) to not assess 
improvement for MIPS-eligible clinicians who are scored in MIPS through 
facility-based measurement in 1 year but through another method in the 
following year.
(vii) Expansion of Facility-Based Measurement To Use in Other Settings
    We initiated the process of facility-based measurement focusing on 
the inpatient hospital setting but noted that we wished to consider 
opportunities to expand the concept into other facilities and programs 
and future years (82 FR 53754). We are particularly interested in the 
opportunity to expand facility-based measurement into post-acute care 
(PAC) and the end-stage renal disease (ESRD) settings and seek comment 
on how we may do so.
    PAC is a significant sector in the spectrum of healthcare services, 
providing services to over 6.9 million Medicare beneficiaries annually 
through Long-Term Care Hospitals (LTCHs), Inpatient Rehabilitation 
Facilities (IRFs), Skilled Nursing Facilities (SNFs), Home Health 
Agencies (HHAs), and Hospice.\30\ Recent legislative efforts have 
focused on improving patient outcomes for PAC through the use of 
standardized patient assessment data to enable information sharing and 
cross-setting quality assessment intended to improve outcomes in 
specified clinical domains. For example, section 2(a) of the Improving 
Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act, Pub. 
L. 113-185 enacted on October 6, 2014) added a new section 1899B to the 
Act, which requires, among other things, that LTCHs, IRFs, SNFs, and 
HHAs submit standardized patient assessment data on the quality 
measures specified under section 1899B(c) of the Act. These cross-
setting quality measures, which must be calculated, at least in part, 
using these standardized patient assessment data, allow for the 
comparability of patient outcomes across PAC settings. Section 1899B(i) 
of the Act requires the Secretary to promulgate regulations and 
interpretive guidelines applicable to LTCHs, HHAs, SNFs and IRFs, 
hospitals and critical access hospitals that require those providers to 
take into account data on measures submitted by LTCHs, HHAs, SNFs and 
IRFs in the discharge planning process.
---------------------------------------------------------------------------

    \30\ MedPAC. Report to the Congress: Medicare Payment Policy. 
2018, Report to the Congress: Medicare Payment Policy, 
www.medpac.gov/docs/default-source/reports/mar18_medpac_entirereport_sec.pdf?sfvrsn=0.
---------------------------------------------------------------------------

    In response to previous rulemakings, commenters have requested the 
opportunity for clinicians who furnish care in PAC settings and bill 
Medicare Part B to be measured similarly to hospital-based clinicians. 
Commenters suggested that this would limit administrative burden on 
clinicians by avoiding clinician reporting of measures which may be 
similar or duplicative to those already reported for facility-based 
programs such as QRPs for certain PAC settings (82 FR 53754).
    In light of the importance of PAC services, PAC legislative 
changes, and the interest of the stakeholder community, we wish to 
explore the opportunity to further align quality and cost measurement 
from the PAC QRPs with the clinicians who provide care in those 
settings. We need to consider alternative ways in which we may use 
measures from the PAC QRPs to measure clinicians in MIPS through 
facility-based measurement.
    Therefore, we are seeking comment on how we may attribute the 
quality and cost of care for patients in PAC settings to clinicians. 
For the facility-based measurement for MIPS program, clinicians receive 
a score that is based on the VBP score of a particular hospital at 
which the clinician or group provides services to patients. We 
specifically solicit comment on whether a similar approach could work 
for PAC given the number and variation of PAC settings and clinicians. 
We are particularly interested to learn what level of influence MIPS-
eligible clinicians have in determining performance on quality measures 
for individual settings and programs in the PAC setting.
    In addition, we invite comments on which PAC QRP measures may be 
best utilized to measure clinician performance. Under our current 
approach for facility-based measurement (that is, the regulations 
finalized previously and the proposals in this rule), all measures in 
the Hospital VBP Program are used to determine the MIPS score. The 
measures used in determining the VBP score reflect the breadth of 
performance in the hospital program and as such would reflect the 
quality of care provided by a clinician.
    We also request comments on methods to identify the appropriate 
measures for scoring, and what measures would be most influenced by 
clinicians. Specifically, we solicit comment on whether all measures 
that are reported as part of the PAC QRPs should be included or whether 
we should identify a subset of measures. The 2020 LTCH QRP includes 19 
measures, of which 3 are proposed to be removed as explained in the FY 
2019 IPPS/LTCH proposed rule (83 FR 20512 through 20515). The 2020 IRF 
QRP includes 18 measures, of which 1 is proposed for removal beginning 
FY 2020 and 1 is proposed for removal beginning FY 2021, as explained 
in the FY 2019 IRF proposed rule (83 FR 21001 through 21002). The 
measures adopted for the 2020 SNF QRP can be found at 82 FR 36570 
through 36594, and none are currently proposed for removal. The 
measures adopted for the 2020 HH QRP can be found at 82 FR 51717 
through 51730. The measures used in the FY 2019 Hospice program can be 
found at 82 FR 36655 through 36656; no measures have been proposed for 
removal for FY 2020 in the FY 2019 Hospice Wage Index proposed rule (83 
FR 20956 through 20957).
    Finally, considering the attribution challenges of using measures 
reported by a facility to measure clinicians, we solicit comment on 
whether we should limit facility-based measurement to specific PAC 
settings and programs such as the IRF QRP or LTCH QRP, or whether we 
should consider all PAC settings in the facility-based measurement 
discussion.
    In addition to our consideration of PAC settings, we also solicit 
comment on opportunities to consider facility-based measurement for 
patients with ESRD. Dialysis facilities treat patients with ESRD and 
acute kidney injury. The ESRD Quality Incentive Program (QIP) was the 
first VBP program that tied Medicare payment to a facility's 
performance on quality measures, and

[[Page 35963]]

payment reductions under that program began with renal dialysis 
services furnished on or after January 1, 2012. Like the Hospital VBP 
program and MIPS, this program determines scores and rewards 
performance based on a set of measures. However, this program only 
allows ESRD facilities that meet a certain threshold to avoid a 
negative payment adjustment and does not allow for a positive payment 
adjustment. We generally believe the scoring methodology associated 
with the ESRD QIP could be integrated into our current approach but 
recognize that the structure is different from the Hospital VBP 
Program. The Payment Year 2020 ESRD QIP measures along with a 
description of our scoring methodology for that payment year can be 
reviewed at 81 FR 77896 through 77931 and 82 FR 50760 through 50767.
    Additionally, we believe MIPS eligible clinicians' roles in 
dialysis centers differ from their roles in hospitals. However, we 
believe that these clinicians have a significant impact on the quality 
of care for patients, even if they cannot control all aspects of their 
care. We seek comment on the extent to which the quality measures of 
dialysis centers reflect clinician performance. Additionally, we seek 
comments on whether we might be able to attribute the performance of a 
specific facility to an individual clinician. We reviewed the 
attribution methodology utilized for the Comprehensive ESRD Care (CEC) 
Model. CMS currently uses the ``first touch'' approach--where the 
beneficiary's first visit to a CEC Model participating dialysis center 
will prospectively match the beneficiary to the dialysis facility. 
While this approach ties a patient to an ESRD facility, it does not tie 
a clinician to an ESRD facility. We also seek comment on whether 
another approach, similar to our consideration of the PAC measures, 
might be more appropriate in this setting.
(e) Scoring the Improvement Activities Performance Category
    For our previously established policies regarding scoring the 
improvement activities performance category, we refer readers to Sec.  
414.1380(b)(3) and the CY 2018 Quality Payment Program final rule (82 
FR 53767 through 53769). We also refer readers to Sec.  414.1355 and 
the CY 2018 Quality Payment Program final rule (82 FR 53648 through 
53662) and CY 2017 Quality Payment Program final rule (81 FR 77177 
through 77199) for previously established policies regarding the 
improvement activities performance category generally.
(i) Regulatory Text Updates
    In this proposed rule, we are proposing updates to both Sec. Sec.  
414.1380(b)(3) and 414.1355 to more clearly and concisely capture 
previously established policies. We are also proposing one substantive 
change with respect to Patient Centered Medical Homes and comparable 
specialty practices. These are discussed in more detail below.
(A) Improvement Activities Performance Category Score and Total 
Required Points
    In an effort to more clearly and concisely capture previously 
established policies, we are proposing updates to Sec.  414.1380(b)(3) 
and refer readers to section VIII for more details.
    We also are clarifying here that the improvement activities 
performance category score cannot exceed 100 percent.
(B) Weighting of Improvement Activities
    In an effort to more clearly and concisely capture previously 
established policies, we are proposing updates to Sec.  414.1380(b)(3) 
and refer readers to section VIII for more details.
(C) APM Improvement Activities Performance Category Score
    In an effort to more clearly and concisely capture previously 
established policies, we are proposing updates to Sec.  
414.1380(b)(3)(i) and refer readers to section VIII for more details.
(D) Patient-Centered Medical Homes and Comparable Specialty Practices
    In this proposed rule, we are proposing to modify our regulations 
at Sec.  414.1380(b)(3)(ii) to more clearly and concisely capture our 
previously established policies for patient-centered medical homes and 
comparable specialty practices and refer readers to section VIII for 
more details.
    In addition, it has come to our attention that in the preamble of 
the CY 2017 Quality Payment Program final rule (81 FR 77186 and 77179), 
the terminology ``automatic'' was used in reference to patient-centered 
medical home or comparable specialty practice improvement activities 
scoring credit. In that rule, in response to one comment, we stated, 
``. . . any MIPS eligible clinician or group that does not qualify by 
October 1st of the performance year as a certified patient-centered 
medical home or comparable specialty practice cannot receive automatic 
credit as such for the improvement activities performance category.'' 
(81 FR 77186). In response to another comment in that rule, we stated, 
``Other certifications that are not for patient-centered medical homes 
or comparable specialty practices would also not qualify automatically 
for the highest score.'' (81 FR 77179).
    While we used the term ``automatic'' then, we have since come to 
believe it is inaccurate because an eligible clinician or group must 
attest to their status as a patient-centered medical home or comparable 
specialty practice in order to receive full credit for the improvement 
activities performance category. In the CY 2018 Quality Performance 
Payment final rule (82 FR 53649) in response to comments we received 
regarding patient-centered medical homes or comparable specialty 
practices receiving full credit for the improvement activities 
performance category for MIPS; we stated that we would like to make 
clear that credit is not automatically granted; MIPS eligible 
clinicians and groups must attest in order to receive the credit.
    Therefore, in this proposed rule, we are codifying at Sec.  
414.1380(b)(3)(ii) to require that an eligible clinician or group must 
attest to their status as a patient-centered medical home or comparable 
specialty practice in order to receive this credit. Specifically, MIPS 
eligible clinicians who wish to claim this status for purposes of 
receiving full credit in the improvement activities performance 
category must attest to their status as a patient-centered medical home 
or comparable specialty practice for a continuous 90-day minimum during 
the performance period.
(E) Improvement Activities Performance Category Weighting for Final 
Scoring
    In this proposed rule, in an effort to more clearly and concisely 
capture previously established policies, we are proposing to make 
technical changes to Sec.  414.1355(b) to state that unless a different 
scoring weight is assigned by CMS under section 1848(q)(5)(F) of the 
Act, performance in the improvement activities performance category 
comprises 15 percent of a MIPS eligible clinician's final score for the 
2019 MIPS payment year and for each MIPS payment year thereafter. We 
believe these changes would better align the regulation text with the 
text of the statute.
(ii) CEHRT Bonus
    In the CY 2017 Quality Payment Program final rule (81 FR 77202 
through 77209) and the CY 2018 Quality Payment Program final rule (82 
FR 53664 through 53670), we established

[[Page 35964]]

that certain activities in the improvement activities performance 
category will qualify for a bonus under the Promoting Interoperability 
performance category if they are completed using CEHRT. This bonus is 
applied under the Promoting Interoperability performance category and 
not under the improvement activities performance category. In section 
III.H.3.h.(5) of this proposed rule, we are proposing a new approach 
for scoring the Promoting Interoperability performance category that is 
aligned with our MIPS program goals of flexibility and simplicity. We 
refer readers to section III.H.3.h.(5)(g) of this proposed rule for 
more details on this proposal.
    We invite public comment on these proposals.
(f) Scoring the Promoting Interoperability Performance Category
    We refer readers to section III.H.3.h.(5) of this proposed rule, 
where we discuss our proposals for scoring the Promoting 
Interoperability performance category.
(2) Calculating the Final Score
    For a description of the statutory basis and our policies for 
calculating the final score for MIPS eligible clinicians, we refer 
readers to Sec.  414.1380(c), the discussion in the CY 2017 Quality 
Payment Program final rule (81 FR 77319 through 77329), and the 
discussion in the CY 2018 Quality Payment Program final rule (82 FR 
53769 through 53785). In this proposed rule, we propose to continue the 
complex patient bonus for the 2021 MIPS payment year, propose a 
modification to the final score calculation for the 2021 MIPS payment 
year, and propose refinements to reweighting policies.
(a) Accounting for Risk Factors
    Section 1848(q)(1)(G) of the Act requires us to consider risk 
factors in our scoring methodology. Specifically, it provides that the 
Secretary, on an ongoing basis, shall, as the Secretary determines 
appropriate and based on individuals' health status and other risk 
factors, assess appropriate adjustments to quality measures, cost 
measures, and other measures used under MIPS and assess and implement 
appropriate adjustments to payment adjustments, final scores, scores 
for performance categories, or scores for measures or activities under 
MIPS. In doing so, the Secretary is required to take into account the 
relevant studies conducted under section 2(d) of the Improving Medicare 
Post-Acute Care Transformation Act of 2014 (IMPACT Act) and, as 
appropriate, other information, including information collected before 
completion of such studies and recommendations.
    In this section, we summarize our efforts related to social risk 
and the relevant studies conducted under section 2(d) of the IMPACT 
Act. We also propose to adjust the final score by continuing a bonus to 
address patient complexity for the 2021 MIPS payment year.
(i) Considerations for Social Risk
    In the CY 2018 Quality Payment Program final rule (82 FR 53770), we 
discussed the importance of improving beneficiary outcomes including 
reducing health disparities. We also discussed our commitment to 
ensuring that medically complex patients, as well as those with social 
risk factors, receive excellent care. We discussed how studies show 
that social risk factors, such as being near or below the poverty level 
as determined by HHS, belonging to a racial or ethnic minority group, 
or living with a disability, can be associated with poor health 
outcomes, and how some of this disparity is related to the quality of 
health care.\31\ Among our core objectives, we aim to improve health 
outcomes, attain health equity for all beneficiaries, and ensure that 
complex patients as well as those with social risk factors receive 
excellent care. Within this context, reports by the Office of the 
Assistant Secretary for Planning and Evaluation (ASPE) and the National 
Academy of Medicine have examined the influence of social risk factors 
in our value-based purchasing programs.\32\ As we noted in the FY 2018 
IPPS/LTCH PPS final rule (82 FR 38428 through 38429), ASPE's Report to 
Congress, found that, in the context of value-based purchasing 
programs, dual eligibility was the most powerful predictor of poor 
health care outcomes among those social risk factors that they examined 
and tested. In addition, as noted in the FY 2018 IPPS/LTCH PPS final 
rule (82 FR 38428), the National Quality Forum (NQF) undertook a 2-year 
trial period in which certain new measures and measures undergoing 
maintenance review have been assessed to determine if risk adjustment 
for social risk factors is appropriate for these measures.\33\ The 
trial period ended in April 2017 and a final report is available at 
https://www.qualityforum.org/SES_Trial_Period.aspx. The trial concluded 
that ``measures with a conceptual basis for adjustment generally did 
not demonstrate an empirical relationship'' between social risk factors 
and the outcomes measured. This discrepancy may be explained in part by 
the methods used for adjustment and the limited availability of robust 
data on social risk factors. NQF has extended the socioeconomic status 
(SES) trial,\34\ allowing further examination of social risk factors in 
outcome measures.
---------------------------------------------------------------------------

    \31\ See, for example, United States Department of Health and 
Human Services. ``Healthy People 2020: Disparities. 2014,'' https://www.healthypeople.gov/2020/about/foundation-health-measures/Disparities or National Academies of Sciences, Engineering, and 
Medicine. Accounting for Social Risk Factors in Medicare Payment: 
Identifying Social Risk Factors. Washington, DC: National Academies 
of Sciences, Engineering, and Medicine 2016.
    \32\ Department of Health and Human Services Office of the 
Assistant Secretary for Planning and Evaluation (ASPE), ``Report to 
Congress: Social Risk Factors and Performance Under Medicare's 
Value-Based Purchasing Programs.'' December 2016. Available at 
https://aspe.hhs.gov/pdf-report/report-congress-social-risk-factors-and-performance-under-medicares-value-based-purchasing-programs.
    \33\ Available at https://www.qualityforum.org/SES_Trial_Period.aspx.
    \34\ Available at https://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=86357.
---------------------------------------------------------------------------

    In the CY 2018 Quality Payment Program proposed rule, we solicited 
feedback on which social risk factors provide the most valuable 
information to stakeholders and the methodology for illuminating 
differences in outcomes rates among patient groups seen by a MIPS 
eligible clinician that would also allow for a comparison of those 
differences, or disparities, across MIPS eligible clinicians (82 FR 
30134). We received feedback encouraging CMS to explore whether 
additional factors should be used to stratify or risk adjust the 
individual quality and cost measures and to consider any additional 
factors that might be appropriate. We intend to explore options for 
adjustment of individual quality measures used in MIPS in future years. 
We also intend to explore additional approaches to account for patient 
risk factors through adjustments to the performance category scores or 
the final score. However, as described in section III.H.3.i.(2)(a)(ii), 
we believe it is appropriate to maintain the complex patient bonus for 
the 2021 MIPS payment year.
    We plan to continue working with ASPE, the public, and other key 
stakeholders on this important issue to identify policy solutions that 
achieve the goals of attaining health equity for all beneficiaries and 
minimizing unintended consequences.
(ii) Complex Patient Bonus for the 2021 MIPS Payment Year
    In the CY 2018 Quality Payment Program final rule, under the 
authority in section 1848(q)(1)(G) of the Act, we

[[Page 35965]]

finalized at Sec.  414.1380(c)(3) a complex patient bonus of up to 5 
points to be added to the final score for the 2020 MIPS payment year 
(82 FR 53771 through 53776). We intended for this bonus to serve as a 
short-term strategy to address the impact patient complexity may have 
on MIPS scoring while we continue to work with stakeholders on methods 
to account for patient risk factors. Our overall goal for the complex 
patient bonus was two-fold: (1) To protect access to care for complex 
patients and provide them with excellent care; and (2) to avoid placing 
MIPS eligible clinicians who care for complex patients at a potential 
disadvantage while we review the completed studies and research to 
address the underlying issues. We noted that we would assess on an 
annual basis whether to continue the bonus and how the bonus should be 
structured (82 FR 53771). For a detailed description of the complex 
patient bonus finalized for the 2020 MIPS payment year, please refer to 
the CY 2018 Quality Payment Program final rule (82 FR 53771 through 
53776).
    For the 2019 MIPS performance period/2021 MIPS payment year, we 
propose to continue the complex patient bonus as finalized for the 2018 
MIPS performance period/2020 MIPS payment year and to revise Sec.  
414.1380(c)(3) to reflect this policy. Although we intend to maintain 
the complex patient bonus as a short-term solution, we do not believe 
we have sufficient information available at this time to develop a 
long-term solution to account for patient risk factors in MIPS such 
that we would be able to include a different approach in this proposed 
rule. An updated ASPE report is expected in October 2019 which will 
build on the analyses included in the initial reports and may provide 
additional input for a long-term solution to addressing risk factors in 
MIPS. At this time, we do not believe additional data sources are 
available that would be feasible to use as the basis for a different 
approach to account for patient risk factors in MIPS. We intend to 
analyze data when feasible from the 2017 MIPS performance period which 
will be available following the data submission deadline on March 31, 
2018 to identify differences in performance that are consistent across 
performance categories and may, in the future, shift the complex 
patient bonus to specific performance categories. However, in the 
absence of data analysis from the first year of MIPS, we do not believe 
that this change is appropriate at this time. Therefore, while we work 
with stakeholders to identify a long-term approach to account for 
patient risk factors in MIPS, we believe it would be appropriate to 
continue the complex patient bonus for another year to support MIPS 
eligible clinicians who treat patients with risk factors, as well as to 
maintain consistency with the 2020 MIPS payment year and minimize 
confusion. We have received significant feedback from MIPS eligible 
clinicians that consistency in the MIPS program over time is valued 
when possible in order to minimize confusion and to help MIPS eligible 
clinicians predict how they will be scored under MIPS. Therefore, we 
believe it is appropriate to maintain consistent policies for the 
complex patient bonus in the 2021 MIPS payment year until we have 
sufficient evidence and new data sources that support an updated 
approach to account for patient risk factors.
    Although we are not proposing changes to the complex patient bonus 
for the 2021 MIPS payment year, the dates used in the calculation of 
the complex patient bonus may change as a result of other proposals we 
are making in this proposed rule. For the 2020 MIPS payment year, we 
finalized that we would use the second 12-month segment of the 
eligibility determination period to calculate average HCC risk scores 
and the proportion of full benefit or partial benefit dual eligible 
beneficiaries for MIPS eligible clinicians (82 FR 53771 through 53772). 
As discussed in section III.H.3.a. of this proposed rule, we are 
proposing to change the dates of the eligibility determination period 
(now referred to as the MIPS determination period) beginning with the 
2021 MIPS payment year. Specifically, the second 12-month segment would 
begin on October 1 of the calendar year preceding the applicable 
performance period and end on September 30 of the calendar year in 
which the applicable performance period occurs. If this proposed change 
to the MIPS determination period is finalized, then beginning with the 
2021 MIPS payment year, the second 12-month segment of the MIPS 
determination period (beginning on October 1 of the calendar year 
preceding the applicable performance period and ending on September 30 
of the calendar year in which the applicable performance period occurs) 
would be used when calculating average HCC risk scores and proportion 
of full benefit or partial benefit dual eligible beneficiaries for MIPS 
eligible clinicians.
(b) Final Score Performance Category Weights
(i) General Weights
    Section 1848(q)(5)(E)(i) of the Act specifies weights for the 
performance categories included in the MIPS final score: In general, 30 
percent for the quality performance category; 30 percent for the cost 
performance category; 25 percent for the Promoting Interoperability 
performance category (formerly the advancing care information 
performance category); and 15 percent for the improvement activities 
performance category. For more of the statutory background and 
descriptions of our current policies, we refer readers to the CY 2017 
and CY 2018 Quality Payment Program final rules (81 FR 77320 and 82 FR 
53779, respectively). Under the proposals we are making in sections 
III.H.3.h.(3)(a) and III.H.3.h.(2)(a) of this proposed rule, for the 
2021 MIPS payment year, the cost performance category would make up 15 
percent and the quality performance category would make up 45 percent 
of a MIPS eligible clinician's final score. Table 50 summarizes the 
weights specified for each performance category.

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


[[Page 35966]]

(ii) Flexibility for Weighting Performance Categories
    Under section 1848(q)(5)(F) of the Act, if there are not sufficient 
measures and activities applicable and available to each type of MIPS 
eligible clinician involved, the Secretary shall assign different 
scoring weights (including a weight of zero) for each performance 
category based on the extent to which the category is applicable to the 
type of MIPS eligible clinician involved and for each measure and 
activity with respect to each performance category based on the extent 
to which the measure or activity is applicable and available to the 
type of MIPS eligible clinician involved. Under section 
1848(q)(5)(B)(i) of the Act, in the case of a MIPS eligible clinician 
who fails to report on an applicable measure or activity that is 
required to be reported by the clinician, the clinician must be treated 
as achieving the lowest potential score applicable to such measure or 
activity. In this scenario of failing to report, the MIPS eligible 
clinician would receive a score of zero for the measure or activity, 
which would contribute to the final score for that MIPS eligible 
clinician. Assigning a scoring weight of zero percent and 
redistributing the weight to the other performance categories differs 
from the scenario of a MIPS eligible clinician failing to report on an 
applicable measure or activity that is required to be reported.
(A) Scenarios Where the Quality, Cost, Improvement Activities, and 
Promoting Interoperability Performance Categories Would Be Reweighted
    In the CY 2017 and CY 2018 Quality Payment Program final rules (81 
FR 77322 through 77325 and 82 FR 53779 through 53780, respectively), we 
explained our interpretation of what it means for there to be 
sufficient measures applicable and available for the quality and cost 
performance categories, and we finalized policies for the 2019 and 2020 
MIPS payment years under which we would assign a scoring weight of zero 
percent to the quality or cost performance category and redistribute 
its weight to the other performance categories in the event there are 
not sufficient measures applicable and available, as authorized by 
section 1848(q)(5)(F) of the Act. For the quality performance category, 
we stated that having sufficient measures applicable and available 
means that we can calculate a quality performance category percent 
score for the MIPS eligible clinician because at least one quality 
measure is applicable and available to the clinician (82 FR 53780). For 
the cost performance category, we stated that having sufficient 
measures applicable and available means that we can reliably calculate 
a score for the cost measures that adequately captures and reflects the 
performance of a MIPS eligible clinician (82 FR 53780). We established 
that if a MIPS eligible clinician is not attributed enough cases for a 
measure (in other words, has not met the required case minimum for the 
measure), or if a measure does not have a benchmark, then the measure 
will not be scored for that clinician (81 FR 77323). We stated that if 
we do not score any cost measures for a MIPS eligible clinician in 
accordance with this policy, then the clinician would not receive a 
cost performance category percent score (82 FR 53780).
    We are proposing to codify these policies for the quality and cost 
performance categories at Sec.  414.1380(c)(2)(i)(A)(1) and (2), 
respectively, and to continue them for the 2021 MIPS payment year and 
each subsequent MIPS payment year.
    For the Promoting Interoperability performance category, in the CY 
2017 Quality Payment Program final rule (81 FR 77238 through 77245) and 
the CY 2018 Quality Payment Program final rule (82 FR 53680 through 
53687), we established policies for assigning a scoring weight of zero 
percent to the Promoting Interoperability performance category and 
redistributing its weight to the other performance categories in the 
final score. We are proposing to codify those policies under Sec.  
414.1380(c)(2)(i) and (iii).
    For the improvement activities performance category, we continue to 
believe that all MIPS eligible clinicians will have sufficient 
activities applicable and available, except for limited extreme and 
uncontrollable circumstances, such as natural disasters, where a 
clinician is unable to report improvement activities, and circumstances 
where a MIPS eligible clinician joins a practice in the final 3 months 
of the performance period as discussed in section 
III.H.3.i.(2)(b)(ii)(C) of this proposed rule. Barring these 
circumstances, we believe that all MIPS eligible clinicians will have 
sufficient improvement activities applicable and available (82 FR 
53780).
(B) Reweighting the Quality, Cost, and Improvement Activities 
Performance Categories for Extreme and Uncontrollable Circumstances
    For a summary of the final policy we adopted beginning with the 
2018 MIPS performance period/2020 MIPS payment year to reweight the 
quality, cost, and improvement activities performance categories based 
on a request submitted by a MIPS eligible clinician, group, or virtual 
group that was subject to extreme and uncontrollable circumstances, we 
refer readers to the CY 2018 Quality Payment Program final rule (82 FR 
53780 through 53783). We are proposing to codify this policy at Sec.  
414.1380(c)(2)(i)(A)(5).
    We sought comment in the CY 2018 Quality Payment Program final rule 
on two topics related to our extreme and uncontrollable policies (82 FR 
53782 through 52783). First, in response to a public comment on the CY 
2018 Quality Payment Program proposed rule in which the commenter 
requested that we include improvement scoring for those who are 
affected by extreme and uncontrollable circumstances, we sought comment 
on ways we could modify our improvement scoring policies to account for 
clinicians who have been affected by extreme and uncontrollable 
circumstances. In response, we received one comment expressing support 
for an improvement score without providing any additional details. At 
this time, we are not proposing modifications to our improvement 
scoring; therefore, MIPS eligible clinicians who receive a zero percent 
weighting for the quality or cost performance categories due to extreme 
and uncontrollable circumstances would not be eligible for improvement 
scoring because data sufficient to measure improvement would not be 
available from the performance period in which the quality or cost 
performance categories are weighted at zero percent.
    We also sought comment on alternatives to the finalized policies, 
such as using a shortened performance period, which may allow us to 
measure performance, rather than reweighting the performance categories 
to zero percent. Many commenters generally supported the extreme and 
uncontrollable circumstances policy as finalized. One commenter 
requested that we reconsider our policy to not include issues third 
party intermediaries might have submitting information to CMS on behalf 
of a MIPS eligible clinician. We considered updating our policy to 
include third party intermediaries; however, we continue to believe 
that inclusion of third party intermediaries is not necessary because 
MIPS eligible clinicians may identify multiple ways to submit data and 
participate in MIPS. We seek comments on the specific circumstances 
under which the extreme and uncontrollable circumstances policy should 
be made applicable to third party intermediary issues. One

[[Page 35967]]

commenter recommended that CMS require MIPS eligible clinicians to 
submit data before an extreme and uncontrollable event and within a 
reasonable timeframe after the event to incentivize quality improvement 
while allowing for flexibility. Although we considered this alternative 
approach, in order to provide maximum flexibility, we continue to 
believe that MIPS eligible clinicians who demonstrate (through a 
reweighting application) that an extreme and uncontrollable event 
impacted their ability to report for a given performance category 
should have reweighting for that performance category for the 
performance period. However, we may consider modifying our policies in 
future years which we would propose through future rulemaking.
    We are proposing a few minor modifications to our extreme and 
uncontrollable circumstances policy. First, beginning with the 2019 
MIPS performance period/2021 MIPS payment year, we are proposing at 
Sec.  414.1380(c)(2)(i)(A)(5) that, if a MIPS eligible clinician 
submits an application for reweighting based on extreme and 
uncontrollable circumstances, but also submits data on the measures or 
activities specified for the quality or improvement activities 
performance categories in accordance with Sec.  414.1325, he or she 
would be scored on the submitted data like all other MIPS eligible 
clinicians, and the categories would not be reweighted. We are 
proposing this modification to align with a similar policy for the 
Promoting Interoperability performance category (82 FR 53680 through 
53682). If a MIPS eligible clinician reports on measures or activities 
specified for the quality or improvement activities performance 
categories, then we assume the clinician believes there are sufficient 
measures or activities applicable and available to the clinician.
    For most quality measures and improvement activities, the data 
submission occurs after the end of the MIPS performance period, so 
clinicians would know about the extreme and uncontrollable circumstance 
prior to submission. However, for the quality performance category, 
measures submitted via the Part B claims submission type are submitted 
by adding quality data codes to a claim. As a result, it is possible 
that a MIPS eligible clinician could have submitted some Part B claims 
data prior to the submission of a reweighting application for extreme 
and uncontrollable events. Under our proposal, we would score the 
quality performance category because we have received data. However, we 
previously finalized at Sec.  414.1380(c) that if a MIPS eligible 
clinician is scored on fewer than two performance categories, he or she 
will receive a final score equal to the performance threshold (81 FR 
77320 through 77321 and 82 FR 53778 through 53779). If a clinician 
experiences an extreme and uncontrollable event that affects all of the 
performance categories, then under our proposal the clinician would 
only be scored on the quality performance category if they submit data 
for only that category. The clinician would also have to submit data 
for the improvement activities or the Promoting Interoperability 
performance categories in order to be scored on two or more performance 
categories and receive a final score different than the performance 
threshold.
    This proposal does not include administrative claims data that we 
receive through the claims submission process and use to calculate the 
cost measures and certain quality measures. As we propose to codify 
under Sec.  414.1325(a)(2)(i), there are no data submission 
requirements for the cost performance category and for certain quality 
measures used to assess performance in the quality performance 
category. We calculate performance on these measures using 
administrative claims data, and clinicians are not required to submit 
any additional data for these measures. Therefore, we do not believe 
that it would be appropriate to void a reweighting application based on 
administrative claims data we receive for measures that do not require 
data submission for purposes of MIPS.
    We also propose to apply the policy we finalized for virtual groups 
in the CY 2018 Quality Payment Program final rule (82 FR 53782 through 
53783) to groups submitting reweighting applications for the quality, 
cost, or improvement activities performance categories based on extreme 
and uncontrollable circumstances. For groups, we would evaluate whether 
sufficient measures and activities are applicable and available to MIPS 
eligible clinicians in the group on a case-by-case basis and determine 
whether to reweight a performance category based on the information 
provided for the individual clinicians and practice location(s) 
affected by extreme and uncontrollable circumstances and the nature of 
those circumstances. While we did not specifically propose to apply 
this policy to groups in the CY 2018 Quality Payment Program proposed 
rule, our intention was to apply the same policy for groups and virtual 
groups, and thus if we adopt this proposal, we would apply the policy 
to groups beginning with the 2018 performance period/2020 MIPS payment 
year.
(C) Reweighting the Quality, Cost, Improvement Activities, and 
Promoting Interoperability Performance Categories for MIPS Eligible 
Clinicians Who Join a Practice in the Final 3 Months of the Performance 
Period Year
    Beginning with the 2019 MIPS performance period, we are proposing 
that a MIPS eligible clinician who joins an existing practice (existing 
TIN) during the final 3 months of the calendar year in which the MIPS 
performance period occurs (the performance period year) that is not 
participating in MIPS as a group would not have sufficient measures 
applicable and available. We are also proposing that a MIPS eligible 
clinician who joins a practice that is newly formed (new TIN) during 
the final 3 months of the performance period year would not have 
sufficient measures applicable and available, regardless of whether the 
clinicians in the practice report for purposes of MIPS as individuals 
or as a group. In each of these scenarios, we are proposing to reweight 
all four of the performance categories to zero percent for the MIPS 
eligible clinician and, because he or she would be scored on fewer than 
two performance categories, the MIPS eligible clinician would receive a 
final score equal to the performance threshold and a neutral MIPS 
payment adjustment under the policy at Sec.  414.1380(c). We propose to 
codify these policies at Sec.  414.1380(c)(2)(i)(A)(3).
    We are proposing this policy because we are not currently able to 
identify these MIPS eligible clinicians (or groups if the group is 
formed in the final 3 months of the performance period year) at the 
start of the MIPS submission period. When we designed our systems, we 
incorporated user feedback that requested eligibility information be 
connected to the submission process. In order to submit data, an 
individual TIN/NPI or the group TIN must be in the files generated from 
the MIPS eligibility determination periods. As discussed in section 
III.H.3.a., we have two 12-month determination periods for eligibility. 
We are proposing that the second 12-month segment of the MIPS 
eligibility determination period would end on September 30 of the 
calendar year in which the applicable MIPS performance period occurs; 
therefore, we would have no eligibility information about clinicians 
who join a practice after September 30 of the performance period year. 
MIPS eligible clinicians who join an existing practice (existing TIN) 
in the

[[Page 35968]]

final 3 months of the performance period year that is not participating 
in MIPS as a group would not be identified by our systems, and we would 
not have the ability to inform them that they are eligible or to 
receive MIPS data from them. Similarly, practices that form (new TIN) 
in the final 3 months of the performance period year would not be in 
the MIPS determination files. Accordingly, the measures and activities 
would not be available because any data from these MIPS eligible 
clinicians would not be accessible to us.
    If a MIPS eligible clinician joins a practice (existing TIN) in the 
final 3 months of the performance period year, and the practice is not 
newly formed and is reporting as a group for the performance period, 
the MIPS eligible clinician would be able to report as part of that 
group. In this case, we are able to accept data for the group because 
the TIN would be in our MIPS eligibility determination files. 
Therefore, we believe the measures and activities would be available in 
this scenario, and reweighting would not be necessary for the MIPS 
eligible clinician. We note that, if a MIPS eligible clinician's TIN/
NPI combination was not part of the group practice during the MIPS 
determination period, the TIN/NPI combination would not be identified 
in our system at the start of the MIPS data submission period; however, 
if the MIPS eligible clinician qualifies to receive the group final 
score under our proposal, we would apply the group final score to the 
MIPS eligible clinician's TIN/NPI combination as soon as the 
information becomes available. Please see section III.H.3.j.(1) of this 
proposed rule for more information about assigning group scores to MIPS 
eligible clinicians.
(D) Proposed Automatic Extreme and Uncontrollable Circumstances Policy 
Beginning With the 2020 MIPS Payment Year
    In conjunction with the CY 2018 Quality Payment Program final rule, 
and due to the impact of Hurricanes Harvey, Irma, and Maria, we issued 
an interim final rule with comment period (IFC) in which we adopted on 
an interim final basis a policy for automatically reweighting the 
quality, improvement activities, and advancing care information (now 
referred to as Promoting Interoperability) performance categories for 
the transition year of MIPS (the 2017 performance period/2019 MIPS 
payment year) for MIPS eligible clinicians who are affected by extreme 
and uncontrollable circumstances affecting entire regions or locales 
(82 FR 53895 through 53900). We propose to codify this policy for the 
quality and improvement activities performance categories at Sec.  
414.1380(c)(2)(i)(A)(6) and for the advancing care information (now 
Promoting Interoperability) performance category at Sec.  
414.1380(c)(2)(i)(C)(3).
    We believe that a similar automatic extreme and uncontrollable 
circumstances policy would be appropriate for any year of the MIPS 
program to account for natural disasters and other extreme and 
uncontrollable circumstances that impact an entire region or locale. As 
we discussed in the interim final rule (82 FR 53897), we believe such a 
policy would reduce burden on clinicians who have been affected by 
widespread catastrophes and would align with existing policies for 
other Medicare programs. We propose at Sec.  414.1380(c)(2)(i)(A)(7) 
and (c)(2)(i)(C)(3) to apply the automatic extreme and uncontrollable 
circumstances policy we adopted for the transition year to subsequent 
years of the MIPS program, beginning with the 2018 MIPS performance 
period and the 2020 MIPS payment year, with a few additions to address 
the cost performance category. For a description of the policy we 
adopted for the MIPS transition year, we refer readers to the 
discussion in the interim final rule (82 FR 53895 through 53900).
    In the interim final rule (82 FR 53897), we stated that we were not 
including the cost performance category in the automatic extreme and 
uncontrollable circumstances policy for the transition year because the 
cost performance category is weighted at zero percent in the final 
score for the 2017 MIPS performance period/2019 MIPS payment year. We 
finalized a 10 percent weight for the cost performance category for the 
2018 MIPS performance period/2020 MIPS payment year (82 FR 53643) and 
are proposing a 15 percent weight for the 2019 performance period/2021 
MIPS payment year (see section III.H.3.h.(3)(a) of this proposed rule). 
For the reasons discussed in the CY 2018 Quality Payment Program final 
rule (82 FR 53781), we believe a MIPS eligible clinician's performance 
on measures calculated based on administrative claims data, such as the 
measures specified for the cost performance category, could be 
adversely affected by a natural disaster or other extreme and 
uncontrollable circumstance, and that the cost measures may not be 
applicable to that MIPS eligible clinician. Therefore, we are proposing 
to include the cost performance category in the automatic extreme and 
uncontrollable circumstances policy beginning with the 2018 MIPS 
performance period/2020 MIPS payment year. Under our policy for the 
transition year, if a MIPS eligible clinician in an affected area 
submits data for any of the MIPS performance categories by the 
applicable submission deadline for the 2017 MIPS performance period, he 
or she will be scored on each performance category for which he or she 
submits data, and the performance category will not be reweighted to 
zero percent in the final score (82 FR 53898). Our policy for the 
transition year did not include measures that are calculated based on 
administrative claims data (82 FR 53898). As discussed in the preceding 
section III.H.3.h.(3)(b), under Sec.  414.1325(e), there are no data 
submission requirements for the cost performance category, and we will 
calculate performance on the measures specified for the cost 
performance category using administrative claims data. We are proposing 
for the cost performance category, if a MIPS eligible clinician is 
located in an affected area, we would assume the clinician does not 
have sufficient cost measures applicable to him or her and assign a 
weight of zero percent to that category in the final score, even if we 
receive administrative claims data that would enable us to calculate 
the cost measures for that clinician.
    In the interim final rule (82 FR 53897), we did not include an 
automatic extreme and uncontrollable circumstances policy for groups or 
virtual groups, and we continue to believe such a policy is not 
necessary. Unless we receive data from a TIN indicating that the TIN 
would like to be scored as a group for MIPS, performance by default is 
assessed at the individual MIPS eligible clinician level. Similarly, 
performance is not assessed at the virtual group level unless the 
member TINs submit an application in accordance with Sec.  414.1315. If 
we receive data from a group or virtual group, we would score that 
data, even if individual MIPS eligible clinicians within the group or 
virtual group are impacted by an event that would be included in our 
automatic extreme and uncontrollable circumstances policy. Regardless 
of whether we receive data from a group or virtual group, we would have 
no mechanism to determine whether the group or virtual group did not 
submit data, or submitted data and performed poorly, because it had 
been affected by an extreme and uncontrollable event unless the group 
notifies us of its circumstances. Instead of establishing a threshold 
for groups or virtual groups to receive automatic reweighting based on 
the number of

[[Page 35969]]

clinicians in the group or virtual group impacted by extreme and 
uncontrollable events, we believe it is preferable that these groups 
and virtual groups submit an application for reweighting based on 
extreme and uncontrollable circumstances under our existing policy (82 
FR 53780 through 53783) where they may be eligible for reweighting if 
they establish that the group or virtual group was sufficiently 
impacted by the extreme and uncontrollable event. For example, if less 
than 100 percent of the clinicians in the group or virtual group were 
impacted, but the practice location that was responsible for data 
submission was among those impacted and thus impeded successful 
reporting for all clinicians in the group or virtual group, we believe 
reweighting may be appropriate.
(iii) Redistributing Performance Category Weights
    In the CY 2017 and CY 2018 Quality Payment Program final rules, we 
established policies for redistributing the weights of performance 
categories for the 2019 and 2020 MIPS payment years in the event that a 
scoring weight different from the generally applicable weight is 
assigned to a category or categories (81 FR 77325 through 77329; 82 FR 
53783 through 53785, 53895 through 53900). We are proposing to codify 
these policies under Sec.  414.1380(c)(2)(ii).
    For the 2021 MIPS payment year, we propose at Sec.  
414.1380(c)(2)(ii)(B) to apply similar reweighting policies as 
finalized for the 2020 MIPS payment year (82 FR 53783 through 53785). 
In general, we would redistribute the weight of a performance category 
or categories to the quality performance category. We continue to 
believe redistributing weight to the quality performance category is 
appropriate because of the experience MIPS eligible clinicians have had 
reporting on quality measures under other CMS programs. We propose to 
continue to redistribute the weight of the quality performance category 
to the improvement activities and Promoting Interoperability 
performance categories. However, for the 2021 MIPS payment year, with 
our proposal to weight cost at 15 percent, we propose to reweight the 
Promoting Interoperability performance category to 45 percent and the 
improvement activities performance category to 40 percent when the 
quality performance category is weighted at zero percent. We chose to 
weight Promoting Interoperability higher in order to align with goals 
of interoperability and for simplicity because we generally have 
avoided assigning partial percentage points to performance category 
weights. Reweighting scenarios under this proposal are presented in 
Table 51.

         Table 51--Performance Category Redistribution Policies Proposed for the 2021 MIPS Payment Year
----------------------------------------------------------------------------------------------------------------
                                                                                  Improvement       Promoting
             Reweighting scenario                   Quality          Cost         activities    Interoperability
                                                   (percent)       (percent)       (percent)        (percent)
----------------------------------------------------------------------------------------------------------------
No Reweighting Needed:
    --Scores for all four performance                       45              15              15               25
     categories...............................
Reweight One Performance Category:
    --No Cost.................................              60               0              15               25
    --No Promoting Interoperability...........              70              15              15                0
    --No Quality..............................               0              15              40               45
    --No Improvement Activities...............              60              15               0               25
Reweight Two Performance Categories:
    --No Cost and no Promoting                              85               0              15                0
     Interoperability.........................
    --No Cost and no Quality..................               0               0              50               50
    --No Cost and no Improvement Activities...              75               0               0               25
    --No Promoting Interoperability and no                   0              15              85                0
     Quality..................................
    --No Promoting Interoperability and no                  85              15               0                0
     Improvement Activities...................
    --No Quality and no Improvement Activities               0              15               0               85
----------------------------------------------------------------------------------------------------------------

    We have heard from stakeholders in previous years that our 
reweighting policies place undue weight on the quality performance 
category, and, although we continue to believe the policies are 
appropriate, we seek comment on alternative redistribution policies in 
which we would also redistribute weight to the improvement activities 
performance category (see Table 52). Under the alternative 
redistribution policy we considered, we would redistribute the weight 
of the Promoting Interoperability performance category to the quality 
and improvement activities performance categories. We would 
redistribute 15 percent of the Promoting Interoperability performance 
category weight to the quality performance category, and 10 percent to 
the improvement activities performance category. We believe 
redistributing more of the weight of the Promoting Interoperability 
performance category to the quality performance category is appropriate 
because MIPS eligible clinicians have had more experience reporting on 
quality measures under other CMS programs than reporting on improvement 
activities. We would redistribute the cost performance category weight 
equally to the quality and improvement activities performance 
categories (5 percent to each) under this alternative policy.

[[Page 35970]]



  Table 52--Alternative Performance Category Redistribution Policies Considered for the 2021 MIPS Payment Year
----------------------------------------------------------------------------------------------------------------
                                                     Alternative redistribution policy:  Reweight promoting
                                                 interoperability and cost to quality and improvement activities
             Reweighting scenario              -----------------------------------------------------------------
                                                                                  Improvement       Promoting
                                                    Quality          Cost         activities    interoperability
----------------------------------------------------------------------------------------------------------------
No Reweighting Needed:
    --Scores for all four performance                       45              15              15               25
     categories...............................
Reweight One Performance Category:
    --No Promoting Interoperability...........              60              15              25                0
    --No Cost.................................              55               0              20               25
    --No Quality..............................               0              15              40               45
    --No Improvement Activities...............              60              15               0               25
Reweight Two Performance Categories:
    --No Cost and No Promoting                              70               0              30                0
     Interoperability.........................
    --No Cost and no Quality..................               0               0              50               50
    --No Cost and no Improvement Activities...              75               0               0               25
    --No Promoting Interoperability and no                   0              15              85                0
     Quality..................................
    --No Promoting Interoperability and no                  85              15               0                0
     Improvement Activities...................
    --No Quality and no Improvement Activities               0              15               0               85
----------------------------------------------------------------------------------------------------------------

    Because the cost performance category was zero percent of a MIPS 
eligible clinician's final score for the 2017 MIPS performance period, 
we did not believe it is appropriate to redistribute weight to the cost 
performance category for the 2019 MIPS performance period because MIPS 
eligible clinicians have limited experience being scored on cost 
measures for purposes of MIPS. In addition, we are concerned that there 
would be limited measures in the cost performance category under our 
proposal for the 2019 MIPS performance period discussed in section 
III.H.3.h.(3)(b) of this proposed rule, and believe it may be 
appropriate to delay shifting additional weight to the cost performance 
category until additional measures are developed. However, we also 
believe that cost is a critical component of the Quality Payment 
Program and believe placing additional emphasis on the cost performance 
category in future years may be appropriate. Therefore, we seek comment 
on redistributing weight to the cost performance category in future 
years.
(c) Final Score Calculation
    We are proposing to revise the formula at Sec.  414.1380(c) for 
calculating the final score. As discussed in section 
III.H.3.i.(1)(b)(vii), we are not proposing to continue to add the 
small practice bonus to the final score for the 2021 MIPS payment year 
and are proposing to add a small practice bonus to the quality 
performance category score instead starting with the 2021 MIPS payment 
year. Therefore, we are proposing to revise the formula to omit the 
small practice bonus from the final score calculation beginning with 
the 2021 MIPS payment year. We request public comments on this 
proposal.
    In the CY 2018 Quality Payment Program final rule (82 FR 53779), we 
requested public comment on approaches to display scores and provide 
feedback to MIPS eligible clinicians in a way that MIPS eligible 
clinicians can easily understand how their scores are calculated, 
including how performance category scores are translated to a final 
score. We also sought comment on how to simplify the scoring system 
while still recognizing differences in clinician practices.
    A few commenters suggested that we make performance category scores 
equal to the number of points they will represent in the final score to 
minimize confusion. For example, the quality performance category score 
would be out of 50 total possible points, when the quality performance 
category weight is 50 percent. A few commenters provided suggestions 
for tools that may help MIPS eligible clinicians to understand scoring 
better. For example, a few commenters suggested that we create an 
interactive online tool for clinicians to calculate their own scores. A 
few commenters suggested that we should not compare MIPS eligible 
clinicians to benchmarks because they do not believe the benchmarks 
actually represent high quality care. One commenter suggested that we 
could simplify scoring by awarding points for multiple performance 
categories for performance on one measure or activity. Another 
commenter requested that we simplify scoring because the commenter 
believes that clinicians may view the program as unfair and be subject 
to negative payment adjustments due to confusion rather than 
performance.
    We thank the commenters for their suggestions, and we will take 
them into consideration in future rulemaking.
    In response to commenters requesting that the total number of 
points available for a performance category should be equivalent to the 
performance category's weight in the final score, we note that various 
reweighting scenarios could mean that the weight of the performance 
categories for each MIPS eligible clinician may vary (for example, if 
the weight of one or more performance categories is redistributed to 
other performance categories), which makes it impossible for all MIPS 
eligible clinicians to have the same total number of points available 
for a performance category. In addition, the total points possible for 
the quality and cost performance categories may vary--for example, if a 
group is scored on the readmission measure they will have a maximum of 
70 points for the 6 measures they are required to submit and the 
readmission measure instead of 60 points for 6 measures for individuals 
and groups who are not scored via Web Interface and who do not have the 
readmission measure. However, we continue to value simplicity in our 
scoring for MIPS and intend to explore approaches to simplify our 
scoring whenever possible in future years. We seek comments on 
approaches to simplify calculation of the final score that take into 
consideration these limitations described above.

[[Page 35971]]

j. MIPS Payment Adjustments
(1) Final Score Used in Payment Adjustment Calculation
    For our previously established policies regarding the final score 
used in payment adjustment calculation, we refer readers to the CY 2017 
Quality Payment Program final rule (81 FR 77330 through 77332) and the 
CY 2018 Quality Payment Program final rule (82 FR 53785 through 53787). 
Under our policies, for groups submitting data using the TIN 
identifier, we will apply the group final score to all the TIN/NPI 
combinations that bill under that TIN during the performance period (82 
FR 53785). We are proposing to modify this policy for the application 
of the group final score, beginning with the 2019 performance period/
2021 MIPS payment year. We are proposing a 15-month window that starts 
with the second 12-month determination period (October 1 prior to the 
MIPS performance period through September of the MIPS performance 
period) and also includes the final 3 months of the performance period 
year (October 1 through December 31 of the performance period year). We 
are proposing for groups submitting data using the TIN identifier, we 
would apply the group final score to all of the TIN/NPI combinations 
that bill under that TIN during the proposed 15-month window. We 
believe that partially aligning with the second 12-month determination 
period creates consistency with our eligibility policies that informs a 
group or eligible clinician of who is eligible. We refer readers to 
section III.H.3.b. of this proposed rule where we discuss our proposals 
related to MIPS determination periods.
    We note that, if a MIPS eligible clinician's TIN/NPI combination 
was not part of the group practice during the MIPS determination 
period, the TIN/NPI combination would not be identified in our system 
at the start of the MIPS data submission period; however, if the MIPS 
eligible clinician qualifies to receive the group final score under our 
proposal, we would apply the group final score to the MIPS eligible 
clinician's TIN/NPI combination as soon as the information becomes 
available.
(2) Establishing the Performance Threshold
    Under section 1848(q)(6)(D)(i) of the Act, for each year of MIPS, 
the Secretary shall compute a performance threshold with respect to 
which the final scores of MIPS eligible clinicians are compared for 
purposes of determining the MIPS payment adjustment factors under 
section 1848(q)(6)(A) of the Act for a year. The performance threshold 
for a year must be either the mean or median (as selected by the 
Secretary, and which may be reassessed every 3 years) of the final 
scores for all MIPS eligible clinicians for a prior period specified by 
the Secretary.
    Section 1848(q)(6)(D)(iii) of the Act included a special rule for 
the initial 2 years of MIPS, which requires the Secretary, prior to the 
performance period for such years, to establish a performance threshold 
for purposes of determining the MIPS payment adjustment factors under 
section 1848(q)(6)(A) of the Act and an additional performance 
threshold for purposes of determining the additional MIPS payment 
adjustment factors under section 1848(q)(6)(C) of the Act, each of 
which shall be based on a period prior to the performance period and 
take into account data available for performance on measures and 
activities that may be used under the performance categories and other 
factors determined appropriate by the Secretary. Section 51003(a)(1)(D) 
of the Bipartisan Budget Act of 2018 amended section 1848(q)(6)(D)(iii) 
of the Act to extend the special rule to apply for the initial 5 years 
of MIPS instead of only the initial 2 years of MIPS.
    In addition, section 51003(a)(1)(D) of the Bipartisan Budget Act of 
2018 added a new clause (iv) to section 1848(q)(6)(D) of the Act, which 
includes an additional special rule for the third, fourth, and fifth 
years of MIPS (the 2021 through 2023 MIPS payment years). This 
additional special rule provides, for purposes of determining the MIPS 
payment adjustment factors under section 1848(q)(6)(A) of the Act, in 
addition to the requirements specified in section 1848(q)(6)(D)(iii) of 
the Act, the Secretary shall increase the performance threshold for 
each of the third, fourth, and fifth years to ensure a gradual and 
incremental transition to the performance threshold described in 
section 1848(q)(6)(D)(i) of the Act (as estimated by the Secretary) 
with respect to the sixth year (the 2024 MIPS payment year) to which 
the MIPS applies.
    To determine a performance threshold to propose for the third year 
of MIPS (2021 MIPS payment year), we again relied upon the special rule 
in section 1848(q)(6)(D)(iii) of the Act, as amended by 51003(a)(1)(D) 
of the Bipartisan Budget Act of 2018. As required by section 
1848(q)(6)(D)(iii) of the Act, we considered data available from a 
prior period with respect to performance on measures and activities 
that may be used under the MIPS performance categories. In accordance 
with newly added clause (iv) of section 1848(q)(6)(D) of the Act, we 
also considered which data could be used to estimate the performance 
threshold for the 2024 MIPS payment year to ensure a gradual and 
incremental transition from the performance threshold we would 
establish for the 2021 MIPS payment year. We considered using the final 
scores for the 2017 MIPS performance period/2019 MIPS payment year; 
however, the data used to calculate the final scores was submitted 
through the first quarter of 2018, and final scores for MIPS eligible 
clinicians were not available in time for us to use in our analyses for 
purposes of this proposed rule. If technically feasible, we would 
consider using the actual data used to determine the final scores for 
the 2019 MIPS payment year to estimate a performance threshold for the 
2024 MIPS payment year in the final rule.
    Because the final scores for MIPS eligible clinicians are not yet 
available to us, we reviewed the data relied upon for the CY 2017 
Quality Payment Program final rule regulatory impact analysis (81 FR 
77514 through 77536) and believe it is the best data currently 
available to us to estimate the actual data for the 2017 MIPS 
performance period/2019 MIPS payment year.
    Specifically, we used data from claims, MIPS eligibility data, 2015 
PQRS data, 2014 PQRS Experience Report, 2014 VM data, National Plan and 
Provider Enumeration System Data, APM participation lists, and initial 
analyses for QP determination to model the estimated MIPS eligible 
clinicians, final scores, and the economic impact of MIPS final score. 
In these models, we assumed that historic PQRS participation 
assumptions would significantly overestimate the impact on clinicians, 
particularly on clinicians in practices with 1 to 15 clinicians, which 
have traditionally had lower participation rates. To assess the 
sensitivity of the impact to the participation rate, we prepared two 
sets of analyses. The first analysis relies on the assumption that a 
minimum 90 percent of MIPS eligible clinicians will participate in 
submitting quality performance category data to MIPS, regardless of 
practice size. The second analysis relies on the assumption that a 
minimum 80 percent of MIPS eligible clinicians will participate in 
submitting quality performance category data to MIPS, regardless of 
practice size (81 FR 77522 through 77523). We also reviewed the 
available data based on actual participation in PQRS (81 FR 77522 
through 77523) without applying any participation assumptions.

[[Page 35972]]

    In accordance with section 1848(q)(6)(D)(i) of the Act, the 
performance threshold for the 2024 MIPS payment year would be either 
the mean or median of the final scores for all MIPS eligible clinicians 
for a prior period specified by the Secretary. When we analyzed the 
estimated final scores for the 2019 MIPS payment year, the mean final 
score was between 63.50 and 68.98 points and the median was between 
77.83 and 82.5 points based on the different participation assumptions. 
For purposes of estimating the performance threshold for the 2024 MIPS 
payment year, we are using the mean final score based on data used for 
the CY 2017 Quality Payment Program final rule regulatory impact 
analysis (81 FR 77514 through 77536), which would result in an 
estimated performance threshold between 63.50 and 68.98 points for the 
2024 MIPS payment year. We note that this is only an estimation we are 
providing in accordance with section 1848(q)(6)(D)(iv) of the Act, and 
we will propose the actual performance threshold for the 2024 MIPS 
payment year in future rulemaking.
    We propose a performance threshold of 30 points for the 2021 MIPS 
payment year to be codified at Sec.  414.1405(b)(6). A performance 
threshold of 30 points would be a modest increase over the performance 
threshold for the 2020 MIPS payment year (15 points), and we believe it 
would provide a gradual and incremental transition to the performance 
threshold we would establish for the 2024 MIPS payment year, which we 
have estimated would be between 63.50 and 68.98 points.
    We want to encourage continued participation and the collection of 
meaningful data by MIPS eligible clinicians. A higher performance 
threshold would help MIPS eligible clinicians strive to achieve more 
complete reporting and better performance and prepare MIPS eligible 
clinicians for the 2024 MIPS payment year. However, a performance 
threshold set too high could also create a performance barrier, 
particularly for MIPS eligible clinicians who did not previously 
participate in PQRS or the EHR Incentive Programs. Additionally, we 
believe a modest increase from the performance threshold for the 2020 
MIPS payment year would be particularly important to reduce the burden 
for MIPS eligible clinicians in small or solo practices. We believe 
that active participation of MIPS eligible clinicians in MIPS will 
improve the overall quality, cost, and care coordination of services 
provided to Medicare beneficiaries.
    We have heard from stakeholders requesting that we continue a low 
performance threshold and from stakeholders requesting that we ramp up 
the performance threshold to help MIPS eligible clinicians prepare for 
a future performance threshold of the mean or median of final scores 
and to meaningfully incentivize higher performance. We have also heard 
from stakeholders who believe a higher performance threshold may 
incentivize higher performance by MIPS eligible clinicians through 
higher positive MIPS payment adjustments for those who exceed the 
performance threshold. We believe that a performance threshold of 30 
points for the 2021 MIPS payment year would provide a gradual and 
incremental increase from the performance threshold of 15 points for 
the 2020 MIPS payment year and could incentivize higher performance by 
MIPS eligible clinicians.
    We also believe that a performance threshold of 30 points 
represents a meaningful increase compared to 15 points, while 
maintaining flexibility for MIPS eligible clinicians in the pathways 
available to achieve this performance threshold. For example, generally 
a MIPS eligible clinician that is reporting individually and is not in 
a small practice could meet the performance threshold of 30 points by 
earning 40 measure achievement points out of 60 total possible measure 
achievement points that could be achieved through performing at the 
highest level of performance for 2 measures and earning 5 measure 
achievement points for each of the 4 other measures submitted for a 
total of 6 required measures submitted in the quality performance 
category (assuming an outcome measure is submitted).\35\ Alternatively, 
a performance threshold of 30 points could be met by performance at 50 
percent for the Promoting Interoperability performance category 
(receiving a 50 percent performance category score with a performance 
category weight of 25 percent of the final score is 12.5 points), 
receiving a 50 percent performance category score for the cost 
performance category (receiving a 50 percent performance category score 
with a performance category weight of 15 percent of the final score is 
7.5 points), and also earning the maximum number of points for the 
improvement activities performance category (which is worth 15 points 
towards the final score), which collectively would produce a final 
score of at least 35 points (15 points for improvement activities + 7.5 
points for cost + 12.5 points for Promoting Interoperability.
---------------------------------------------------------------------------

    \35\ The score for the quality performance category would be (10 
measure achievement points x 2 measures plus 5 measure achievement 
points x 4 measures)/60 total possible achievement points or 66.67 
percent. That score could be higher if the clinician qualifies for 
bonuses in the quality performance category. The 66.67 percent 
quality performance category percent score is weighted at 45 percent 
of the final score which is multiplied by 100 and equals 30 points 
towards the final score.
---------------------------------------------------------------------------

    We refer readers to section III.H.3.j.(4)(e) of this proposed rule 
for additional examples of how a MIPS eligible clinician can meet or 
exceed the performance threshold. We invite public comment on the 
proposal to set the performance threshold for the 2021 MIPS payment 
year at 30 points. Alternatively, we considered whether the performance 
threshold should be set at a higher or lower number, for example, 25 
points or 35 points, and also seek comment on alternative numerical 
values for the performance threshold for the 2021 MIPS payment year.
    We also seek comment on our approach to estimating the performance 
threshold for the 2024 MIPS payment year, which above we based on the 
estimated mean final score for the 2019 MIPS payment year. We are 
particularly interested in whether we should use the median, instead of 
the mean, and whether in the future we should estimate the mean or 
median based on the final scores for another MIPS payment year. In our 
model estimates, we have seen that the mean scores are lower than the 
median and would expect a larger proportion of clinicians estimated to 
have final scores above the mean, rather than the median, because the 
mean is lower than the median with those who do not submit the required 
data getting the lowest possible score. That in turn could lower the 
scaling factor compared to a performance threshold based on the median. 
We also seek comment on whether establishing a path forward to a 
performance threshold for the 2024 MIPS payment year that provides 
certainty to clinicians and ensures a gradual and incremental increase 
from the performance threshold for the 2021 MIPS payment year to the 
estimated performance threshold for the 2024 MIPS payment year would be 
beneficial. For example, we could consider setting a performance 
threshold of 30 points for the 2021 MIPS payment year, 50 points for 
the 2022 MIPS payment year, and 70 points for the 2023 MIPS payment 
year as gradual and incremental increases toward the estimated 
performance threshold for the 2024 MIPS payment year based on our 
estimated median final scores discussed above; or we could have 
slightly lower values if we were to continue to

[[Page 35973]]

estimate the performance threshold for the 2024 MIPS payment year based 
on our estimated mean final scores. We believe there may be value to 
MIPS eligible clinicians in knowing in advance the performance 
threshold for the 2022 and 2023 MIPS payment years to encourage and 
facilitate increased clinician engagement and prepare clinicians for 
meeting the performance threshold for the 2024 MIPS payment year. 
Alternatively, we also believe that our estimates for the 2024 MIPS 
payment year performance threshold may change as we analyze actual MIPS 
data and, therefore, it may be appropriate to propose the performance 
threshold annually as we better understand the mean and median final 
scores.
(3) Additional Performance Threshold for Exceptional Performance
    Section 1848(q)(6)(D)(ii) of the Act requires the Secretary to 
compute, for each year of the MIPS, an additional performance threshold 
for purposes of determining the additional MIPS payment adjustment 
factors for exceptional performance under section 1848(q)(6)(C) of the 
Act. For each such year, the Secretary shall apply either of the 
following methods for computing the additional performance threshold: 
(1) The threshold shall be the score that is equal to the 25th 
percentile of the range of possible final scores above the performance 
threshold determined under section 1848(q)(6)(D)(i) of the Act; or (2) 
the threshold shall be the score that is equal to the 25th percentile 
of the actual final scores for MIPS eligible clinicians with final 
scores at or above the performance threshold for the prior period 
described in section 1848(q)(6)(D)(i) of the Act.
    Under section 1848(q)(6)(C) of the Act, a MIPS eligible clinician 
with a final score at or above the additional performance threshold 
will receive an additional MIPS payment adjustment factor and may share 
in the $500,000,000 of funding available for the year under section 
1848(q)(6)(F)(iv) of the Act.
    As we discussed in section III.H.3.j.(2) of this proposed rule, we 
are relying on the special rule under section 1848(q)(6)(D)(iii) of the 
Act, as amended by section 51003(a)(1)(D) of the Bipartisan Budget Act 
of 2018, to propose a performance threshold of 30 points for the 2021 
MIPS payment year. The special rule under section 1848(q)(6)(D)(iii) of 
the Act also applies for purposes of establishing an additional 
performance threshold for a year. For the 2021 MIPS payment year, we 
are proposing to again decouple the additional performance threshold 
from the performance threshold.
    Because we do not have actual MIPS final scores for a prior 
performance period, if we do not decouple the additional performance 
threshold from the performance threshold, then we would have to set the 
additional performance threshold at the 25th percentile of possible 
final scores above the performance threshold. With a performance 
threshold set at 30 points, the range of total possible points above 
the performance threshold is 30.01 to 100 points and the 25th 
percentile of that range is 47.5, which is less than one-half of the 
possible 100 points in the MIPS final score. We do not believe it would 
be appropriate to lower the additional performance threshold to 47.5 
points because we do not believe a final score of 47.5 points 
demonstrates exceptional performance by a MIPS eligible clinician. We 
believe these additional incentives should only be available to those 
clinicians with very high performance on the MIPS measures and 
activities. Therefore, we are relying on the special rule under section 
1848(q)(6)(D)(iii) of the Act and propose at Sec.  414.1405(d)(5) to 
set the additional performance threshold at 80 points for the 2021 MIPS 
payment year, which is higher than the 25th percentile of the range of 
the possible final scores above the performance threshold.
    As required by section 1848(q)(6)(D)(iii) of the Act, we took into 
account the data available and the modeling described in section VII. 
of this proposed rule to estimate final scores for the 2021 MIPS 
payment year. We believe 80 points is appropriate because it is vital 
to incentivize clinicians who have made greater strides to meaningfully 
participate in the MIPS program to perform at even higher levels. An 
additional performance threshold of 80 points requires a MIPS eligible 
clinician to perform well on at least two performance categories. 
Generally, a MIPS eligible clinician could receive a maximum score of 
45 points for the quality performance category, which is below the 80-
point additional performance threshold. In addition, 80 points is at a 
high enough level that MIPS eligible clinicians must submit data for 
the quality performance category to achieve this target. For example, 
if a MIPS eligible clinician gets a perfect score for the improvement 
activities, the cost, and Promoting Interoperability performance 
categories, but does not submit quality measures data, then the MIPS 
eligible clinician would only receive 55 points (0 points for quality + 
15 points for the cost performance category + 15 points for improvement 
activities + 25 points for Promoting Interoperability performance 
category), which is below the additional performance threshold. We 
believe the additional performance threshold at 80 points increases the 
incentive for excellent performance while keeping the focus on quality 
performance.
    We also believe this increase would encourage increased engagement 
and further incentivize clinicians whose performance meets or exceeds 
the additional performance threshold, recognizing that a fixed amount 
is available for a year under section 1848(q)(6)(F)(iv) of the Act to 
fund the additional MIPS payment adjustments and that the more 
clinicians who receive an additional MIPS payment adjustment, the lower 
the average clinician's additional MIPS payment adjustment will be.
    For future years, we may consider additional increases to the 
additional performance threshold.
(4) Application of the MIPS Payment Adjustment Factors
(a) Application to the Medicare Paid Amount for Covered Professional 
Services
    In the CY 2018 Quality Payment Program final rule, we finalized the 
application of the MIPS payment adjustment factor, and if applicable, 
the additional MIPS payment adjustment factor, to the Medicare paid 
amount for items and services paid under Part B and furnished by the 
MIPS eligible clinician during the year (82 FR 53795). Sections 
51003(a)(1)(A)(i) and 51003(a)(1)(E) of the Bipartisan Budget Act of 
2018 amended sections 1848(q)(1)(B) and 1848(q)(6)(E) of the Act, 
respectively, by replacing the references to ``items and services'' 
with ``covered professional services'' (as defined in section 
1848(k)(3)(A) of the Act). Covered professional services as defined in 
section 1848(k)(3)(A) of the Act are those services for which payment 
is made under, or is based on, the Medicare Physician Fee Schedule and 
which are furnished by an eligible professional. As a result of these 
changes, the MIPS payment adjustment factor determined under section 
1848(q)(6)(A), and as applicable, the additional MIPS payment 
adjustment factor determined under section 1848(q)(6)(C) of the Act, 
will be applied to Part B payments for covered professional services 
furnished by a MIPS eligible clinician during a year beginning with the 
2019 MIPS payment year and not to Part B payments for other items and 
services.

[[Page 35974]]

    To conform with these amendments to the statute, we are proposing 
to revise Sec.  414.1405(e) to apply the MIPS payment adjustment factor 
and, if applicable, the additional MIPS payment adjustment factor, to 
the Medicare Part B paid amount for covered professional services 
furnished by a MIPS eligible clinician during a MIPS payment year 
(beginning with 2019). We are also proposing to revise Sec.  
414.1405(e) to specify the formula for applying these adjustment 
factors in a manner that more closely tracks the statutory formula 
under section 1848(q)(6)(E) of the Act. Specifically, we are proposing 
the following formula: In the case of covered professional services (as 
defined in section 1848(k)(3)(A) of the Act) furnished by a MIPS 
eligible clinician during a MIPS payment year beginning with 2019, the 
amount otherwise paid under Part B with respect to such covered 
professional services and MIPS eligible clinician for such year, is 
multiplied by 1, plus the sum of: The MIPS payment adjustment factor 
divided by 100, and as applicable, the additional MIPS payment 
adjustment factor divided by 100. We also refer readers to section 
III.H.3.a. of this proposed rule where we discuss the covered 
professional services to which the MIPS payment adjustment could be 
applied.
(b) Application for Non-Assigned Claims for Non-Participating 
Clinicians
    In the CY 2018 Quality Payment Program final rule, we did not 
address the application of the MIPS payment adjustment for non-assigned 
claims for non-participating clinicians. In the CY 2018 Quality Payment 
Program final rule, we responded to a comment requesting guidance on 
how the MIPS payment adjustment and the calculation of the Medicare 
limiting charge amount would be applied for non-participating 
clinicians, and we stated our intention to address these issues in 
future rulemaking (82 FR 53795). Beginning with the 2019 MIPS payment 
year, we are proposing that the MIPS payment adjustment does not apply 
for non-assigned claims for non-participating clinicians. This approach 
is consistent with the policy for application of the value modifier 
that was finalized in the CY 2015 Physician Fee Schedule final rule (79 
FR 67950 through 67951). Sections 1848(q)(6)(A) and 1848(q)(6)(C) of 
the Act require that we specify a MIPS payment adjustment factor, and 
if applicable, an additional MIPS payment adjustment factor for each 
MIPS eligible clinician, and section 1848(q)(6)(E) of the Act (as 
amended by section 51003(a)(1)(E) of the Bipartisan Budget Act of 2018) 
requires that these payment adjustment factor(s) be applied to adjust 
the amount otherwise paid under Part B for covered professional 
services furnished by the MIPS eligible clinician during the MIPS 
payment year. When non-participating clinicians choose not to accept 
assignment for a claim, Medicare makes payment directly to the 
beneficiary, and the physician collects payment from the beneficiary. 
This is referred to as a non-assigned claim. Application of the MIPS 
payment adjustment to these non-assigned claims would not affect 
payment to the MIPS eligible clinician. Rather, it would only affect 
Medicare payment to the beneficiary. If the MIPS payment adjustment 
were to be applied to non-assigned services, then the Medicare payment 
to a beneficiary would be increased when the MIPS payment adjustment is 
positive and decreased when the MIPS payment adjustment is negative. 
Although the statute does not directly address this situation, it does 
suggest that the MIPS payment adjustment is directed toward payment to 
the MIPS eligible clinician and the covered professional services they 
furnish. We continue to believe that it is important that beneficiary 
liability not be affected by the MIPS payment adjustment and that the 
MIPS payment adjustment should be applied to the amount that Medicare 
pays to MIPS eligible clinicians.
    On that basis, we propose to apply the MIPS payment adjustment to 
claims that are billed and paid on an assignment-related basis, and not 
to any non-assigned claims, beginning with the 2019 MIPS payment year. 
We do not expect this proposal, that the MIPS payment adjustment would 
not apply to non-assigned claims, would be likely to affect a 
clinician's decision to participate in Medicare or to otherwise accept 
assignment for a particular claim, but we seek comment on whether 
stakeholders and others believe clinician behavior would change as a 
result of this policy.
(c) Waiver of the Requirement To Apply the MIPS Payment Adjustment 
Factors to Certain Payments in Models Tested Under Section 1115A of the 
Social Security Act
    CMS tests models under section 1115A of the Act that may include 
model-specific payments made only to model participants under the terms 
of the model and not to any other providers of services or suppliers. 
Some of these model-specific payments may be considered payments for 
covered professional services furnished by a MIPS eligible clinician, 
meaning that the MIPS payment adjustment factor, and, as applicable, 
the additional MIPS payment adjustment factor (collectively referred to 
as the MIPS payment adjustment factors) applied under Sec.  414.1405(e) 
of our regulations would normally apply to those payments. Section 
1115A(d)(1) of the Act authorizes the Secretary to waive requirements 
of Title XVIII of the Act (and certain other requirements) as may be 
necessary solely for the purposes of testing models under section 
1115A. We believe it is necessary to waive the requirement to apply the 
MIPS payment adjustment factors to a model-specific payment or payments 
(to the extent such a payment or payments are subject to the 
requirement to apply the MIPS payment adjustment factors) for purposes 
of testing a section 1115A model under which such model-specific 
payment or payments are made in a specified payment amount (for 
example, $160 per-beneficiary, per-month); or paid according to a 
methodology for calculating a model-specific payment that is applied in 
a consistent manner to all model participants. In both cases, applying 
the MIPS payment adjustment factors to these model-specific payments 
would introduce variation in the amounts of model-specific payments 
paid across model participants, which could compromise the model test 
and the evaluation thereof.
    We propose to amend Sec.  414.1405 to add a new paragraph (f) to 
specify that the MIPS payment adjustment factors applied under Sec.  
414.1405(e) would not apply to certain model-specific payments as 
described above for the duration of a section 1115A model's testing, 
beginning in the 2019 MIPS payment year. We are proposing to use the 
authority under section 1115A(d)(1) of the Act to waive the requirement 
to apply the MIPS payment adjustment factors under section 
1848(q)(6)(E) of the Act and Sec.  414.1405(e) specifically for these 
types of payments because the waiver is necessary solely for purposes 
of testing models that involve such payments.
    We believe this policy is appropriate because it would enable us to 
effectively test and evaluate the payment and savings impacts of such 
model-specific payments made under section 1115A models during model 
testing, which may not be possible if the requirement to apply the MIPS 
payment adjustment factors was not waived. This waiver would not apply 
to payments made outside of a section 1115A model with respect to both 
MIPS eligible clinicians that are participating in and MIPS eligible 
clinicians that are not participating in a section 1115A model.

[[Page 35975]]

    To illustrate how this waiver would apply, one model-specific 
payment to which this proposed rule would apply is the Monthly Enhanced 
Oncology Services (MEOS) payment in the Oncology Care Model (OCM). The 
duration of this waiver would begin with the 2019 MIPS payment year and 
continue for the duration of OCM. Application of our proposed 
regulation to the MEOS payment illustrates why the waiver is necessary 
for some payments under section 1115A models. OCM incorporates two 
model-specific payments for participating practices, creating 
incentives to improve the quality of care at a lower cost and furnish 
enhanced services for beneficiaries who undergo chemotherapy treatment 
for a cancer diagnosis. There is a per-beneficiary per-month MEOS 
payment for the duration of each 6-month episode of chemotherapy care 
attributed to the practice, and there is the potential for a 
performance-based payment for such episodes.
    MEOS payments are for Enhanced Services furnished to the OCM 
practices' beneficiary population for attributed episodes of care (that 
is, 24/7 access, patient navigation, care planning, and using therapies 
consistent with nationally recognized clinical guidelines); while some 
beneficiaries attributed to an OCM Practice will require more support 
than others, all beneficiaries in episodes of care attributed to an OCM 
practice have access to the OCM Enhanced Services throughout their 6-
month episode. The MEOS payment is set at $160 per beneficiary per 
month for all OCM Practitioners. Because the MEOS payments are made for 
services for which payment is made under, or based on the PFS and which 
are furnished by an eligible clinician, they are considered covered 
professional services as defined in section 1848(k)(3)(A) of the Act. 
Accordingly, beginning in 2019 (the first MIPS payment year), the MEOS 
payments would be subject to the MIPS payment adjustments (positive, 
neutral, or negative) that are applicable for each OCM Practitioner who 
is a MIPS eligible clinician (at the TIN/NPI level) unless the 
requirement to apply the MIPS payment adjustment factors to the MEOS 
payments is waived pursuant to section 1115A(d)(1) of the Act.
    We believe it is necessary to waive the requirement to apply the 
MIPS payment adjustment factors to the MEOS payments solely for 
purposes of testing OCM because we established the $160 per beneficiary 
per month MEOS payment rate after careful study and consideration, and 
we are specifically testing the impact and appropriateness of $160 as 
the per beneficiary per month MEOS payment amount to OCM Practitioners. 
Though some payment adjustments such as sequestration apply to MEOS 
payments, we do not apply others that would result in differential 
payments across OCM Practitioners, such as the Geographic Pricing Cost 
Index adjustment and Value-Based Payment Modifier for CY 2018. If the 
MEOS payments were subject to the MIPS payment adjustment, the MEOS 
payment amount would not be consistent for all OCM Practitioners across 
the OCM. We are concerned that the resulting differential MEOS payment 
amounts would increase the complexity of the model evaluation. 
Specifically, if OCM practices receive differential MEOS payment 
amounts, they would therefore receive different levels of payment from 
OCM per attributed beneficiary, which could provide differential 
incentives for OCM practices to invest in care coordination and other 
practice transformation activities. This would substantially increase 
the complexity of evaluating the impact of the model, as it would be 
challenging to evaluate how these differential payment amounts 
influence outcomes, potentially lessening our ability to accurately 
discern whether $160 per beneficiary per month is the appropriate 
payment amount. These differential payment amounts may also potentially 
distort CMS's intent to incentivize the provision of enhanced oncology 
care by OCM Practitioners via a standardized per-beneficiary per-month 
payment for such services.
    We propose to provide the public with notice that this proposed new 
regulation applies to model-specific payments that the Innovation 
Center elects to test in the future in two ways: First, we will update 
the Quality Payment Program website (www.qpp.cms.gov) when new model-
specific payments subject to this proposed waiver are announced, and 
second, we will provide a notice in the Federal Register to update the 
public on any new model-specific payments to which this waiver will 
apply.
(d) CY 2018 Exclusion of MIPS Eligible Clinicians Participating in the 
Medicare Advantage Qualifying Payment Arrangement Incentive (MAQI) 
Demonstration
    In conjunction with releasing this proposed rule, CMS is announcing 
the MAQI Demonstration, authorized under section 402 of the Social 
Security Amendments of 1968 (as amended). The MAQI Demonstration is 
designed to test whether excluding MIPS eligible clinicians who 
participate to a sufficient degree in certain payment arrangements with 
Medicare Advantage Organizations (MAOs) from the MIPS reporting 
requirements and payment adjustment will increase or maintain 
participation in payment arrangements similar to Advanced APMs with 
MAOs and change the manner in which clinicians deliver care.
    If the waivers proposed below are finalized, the MAQI Demonstration 
will allow certain participating clinicians to be excluded from the 
MIPS reporting requirements and payment adjustment (if the clinicians 
participate to a sufficient degree in a combination of Qualifying 
Payment Arrangements with MAOs and Advanced APMs with Medicare FFS 
during the performance period for that year) without meeting the 
criteria to be QPs or otherwise meeting a MIPS exclusion criterion 
under the Quality Payment Program. For example, eligible clinicians 
that did not meet the criteria to be a QP for a given year, or were not 
otherwise eligible to be excluded from MIPS (that is, were not newly 
enrolled in Medicare or did not fall below the low volume threshold for 
Medicare FFS patients or payments) could be excluded from the MIPS 
reporting requirements and payment adjustment through the 
Demonstration. For purposes of the MAQI Demonstration, we would apply 
requirements for Qualifying Payment Arrangements that are consistent 
with the criteria for Other Payer Advanced APMs under the Quality 
Payment Program as set forth in Sec.  414.1420. In addition, we are 
proposing that the combined thresholds for Medicare payments or 
patients through Qualifying Payment Arrangements with MAOs and Advanced 
APMs that a participating clinician must meet in order to attain 
waivers of the MIPS reporting requirements and payment adjustment 
through the MAQI Demonstration matches the thresholds for participation 
in Advanced APMs under the Medicare Option of the Quality Payment 
Program. In 2018, those thresholds are 25 percent for the payment 
amount threshold and 20 percent for the patient count threshold. Under 
the MAQI Demonstration, aggregate participation in Advanced APMs and 
Qualifying Payment Arrangements will be used, without applying a 
specific minimum threshold to participation in either type of payment 
arrangement.
    Section 402(b) of the Social Security Amendments of 1968 (as 
amended) authorizes the Secretary to waive requirements of Title XVIII 
that relate to payment and reimbursement in order to carry out 
demonstrations under section

[[Page 35976]]

402(a). We propose to use the authority in section 402(b) of the Social 
Security Amendments of 1968 (as amended) to waive requirements of 
section 1848(q)(6)(E) of the Act and the regulations implementing it, 
to waive the payment consequences (positive, negative or neutral 
adjustments) of the MIPS and to waive the associated MIPS reporting 
requirements in 42 CFR part 414 adopted to implement the payment 
consequences, subject to conditions outlined in the Demonstration. As a 
practical matter, the waiver would have the effect of acting as another 
exclusion from MIPS for eligible clinicians who participate in the MAQI 
Demonstration and meet the performance thresholds set in the 
demonstration. To qualify for these waivers, a participating clinician 
must participate to a sufficient degree in Qualifying Payment 
Arrangements with MAOs and Advanced APMs in FFS Medicare during the 
performance period for that year, without meeting the criteria to be 
QPs or Partial QPs, or otherwise meeting the MIPS exclusion criteria of 
the Quality Payment Program. The threshold to qualify for the waivers 
using participation in these specific payment arrangements could be met 
in one of two ways: A certain percentage of payments or patients is 
tied to participation in a combination of Advanced APMs and Qualifying 
Payment Arrangements. These thresholds will match the thresholds under 
the Medicare Option of the Quality Payment Program. We propose to begin 
the MAQI Demonstration in Calendar 2018, with the 2018 Performance 
Period, and operate the project for a total of 5 years.
    The Demonstration will also waive the provision in section 
1848(q)(1)(A) of the Act that the Secretary shall permit any eligible 
clinician to report on applicable measures and activities, so that the 
Demonstration will prohibit reporting under the MIPS by eligible 
clinicians who participate in the Demonstration and meet the thresholds 
to receive the waivers from the MIPS reporting requirements and payment 
adjustment for a given year. This waiver is necessary to prevent the 
potential gaming opportunity wherein participating clinicians could 
intentionally report artificially poor performance under the MIPS for 
years in which they receive waivers from MIPS payment consequences, 
then receive artificially inflated quality improvement points under 
MIPS in later years when they do not receive waivers from MIPS payment 
consequences. We believe this waiver is necessary under the 
Demonstration because the Demonstration creates a scenario in which 
participating clinicians could report to MIPS, not be subject to the 
MIPS payment adjustment for that year, but have that year's data used 
in the calculation of quality improvement points in future years. 
Clinicians who are excluded from the MIPS reporting requirements and 
payment adjustment through participation in the Demonstration would not 
be permitted to report to MIPS. Clinicians who participate in the 
Demonstration but are not excluded from MIPS (whether through 
participation in the Demonstration or otherwise) would continue to be 
MIPS eligible clinicians who are subject to the MIPS reporting 
requirements and payment adjustment as usual.
    Because of the requirement to ensure budget neutrality with regard 
to the MIPS payment adjustments under section 1848(q)(6)(F)(ii) of the 
Act, removing MIPS eligible clinicians from the population across which 
positive and negative payment adjustments are calculated under MIPS may 
affect the payment adjustments for other MIPS eligible clinicians. 
Specifically, the Demonstration would exclude certain clinicians from 
the pool of MIPS eligible clinicians for which the MIPS payment 
adjustments are calculated, thereby decreasing the aggregate allowed 
charges resulting from the application of MIPS adjustment factors 
included in the budget neutrality determination. The application of 
waivers to MIPS eligible clinicians participating to a sufficient 
degree in the MAQI Demonstration may have the effect of changing the 
aggregate amount of MIPS payment adjustments received by MIPS eligible 
clinicians to whom the waivers do not apply. The Demonstration is 
contingent on the finalization of these waivers through rulemaking due 
to its effect on MIPS payment adjustments for other clinicians.
    We invite comment on this proposal.
    (e) Example of Adjustment Factors
    We provide a figure and several tables as illustrative examples of 
how various final scores would be converted to a MIPS payment 
adjustment factor, and potentially an additional MIPS payment 
adjustment factor, using the statutory formula and based on our 
proposed policies for the 2021 MIPS payment year.
    Figure A (below) provides an example of how various final scores 
would be converted to a MIPS payment adjustment factor, and potentially 
an additional MIPS payment adjustment factor, using the statutory 
formula and based on proposed policies for the 2021 MIPS payment year. 
In Figure A, the performance threshold is 30 points. The applicable 
percentage is 7 percent for the 2021 MIPS payment year. The MIPS 
payment adjustment factor is determined on a linear sliding scale from 
zero to 100, with zero being the lowest possible score which receives 
the negative applicable percentage (negative 7 percent for the 2021 
MIPS payment year) and resulting in the lowest payment adjustment, and 
100 being the highest possible score which receives the highest 
positive applicable percentage and resulting in the highest payment 
adjustment. However, there are two modifications to this linear sliding 
scale. First, there is an exception for a final score between zero and 
one-fourth of the performance threshold (zero and 7.5 points based on 
the performance threshold of 30 points for the 2021 MIPS payment year). 
All MIPS eligible clinicians with a final score in this range would 
receive the lowest negative applicable percentage (negative 7 percent 
for the 2021 MIPS payment year). Second, the linear sliding scale line 
for the positive MIPS payment adjustment factor is adjusted by the 
scaling factor, which cannot be higher than 3.0.
    If the scaling factor is greater than zero and less than or equal 
to 1.0, then the MIPS payment adjustment factor for a final score of 
100 would be less than or equal to 7 percent. If the scaling factor is 
above 1.0, but less than or equal to 3.0, then the MIPS payment 
adjustment factor for a final score of 100 would be higher than 7 
percent.
    Only those MIPS eligible clinicians with a final score equal to 30 
points (which is the performance threshold in this example) would 
receive a neutral MIPS payment adjustment. Because the performance 
threshold is 30 points, we anticipate that more clinicians will receive 
a positive adjustment than a negative adjustment and that the scaling 
factor would be less than 1 and the MIPS payment adjustment factor for 
each MIPS eligible clinician with a final score of 100 points would be 
less than 7 percent.
    Figure A illustrates an example of the slope of the line for the 
linear adjustments and has been updated from prior rules, but it could 
change considerably as new information becomes available. In this 
example, the scaling factor for the MIPS payment adjustment factor is 
0.229. In this example, MIPS eligible clinicians with a final score 
equal to 100 would have a MIPS payment adjustment factor of 1.60 
percent (7 percent x 0.229).
    The additional performance threshold is 80 points. An additional 
MIPS payment adjustment factor of 0.5

[[Page 35977]]

percent starts at the additional performance threshold and increases on 
a linear sliding scale up to 10 percent. This linear sliding scale line 
is also multiplied by a scaling factor that is greater than zero and 
less than or equal to 1.0. The scaling factor will be determined so 
that the estimated aggregate increase in payments associated with the 
application of the additional MIPS payment adjustment factors is equal 
to $500,000,000. In Figure A, the example scaling factor for the 
additional MIPS payment adjustment factor is 0.407. Therefore, MIPS 
eligible clinicians with a final score of 100 would have an additional 
MIPS payment adjustment factor of 4.07 percent (10 percent x 0.407). 
The total adjustment for a MIPS eligible clinician with a final score 
equal to 100 would be 1 + 0.0106 + 0.0407 = 1.0567, for a total 
positive MIPS payment adjustment of 5.67 percent.

BILLING CODE 4120-01-P

[[Page 35978]]

[GRAPHIC] [TIFF OMITTED] TP27JY18.044

BILLING CODE 4120-01-C

    The final MIPS payment adjustments will be determined by the 
distribution of final scores across MIPS eligible clinicians and the 
performance threshold. More MIPS eligible clinicians above the 
performance threshold means the scaling factors would decrease because 
more MIPS eligible clinicians receive a positive MIPS payment 
adjustment factor. More MIPS eligible clinicians below the performance 
threshold means the scaling factors would increase because more MIPS 
eligible clinicians would receive a negative MIPS payment adjustment 
factor and relatively fewer MIPS eligible

[[Page 35979]]

clinicians would receive a positive MIPS payment adjustment factor.
    Table 53 illustrates the changes in payment adjustments based on 
the final policies from the 2019 MIPS payment year and the 2020 MIPS 
payment year, and on the proposed policies for the 2021 MIPS payment 
year, as well as the statutorily required increase in the applicable 
percent as required by section 1848(q)(6)(B) of the Act.

  Table 53--Illustration of Point System and Associated Adjustments Comparison Between Transition Year and the
                                2020 MIPS Payment Year and 2021 MIPS Payment Year
----------------------------------------------------------------------------------------------------------------
           Transition year                    2020 MIPS payment year                2021 MIPS payment year
----------------------------------------------------------------------------------------------------------------
                                                                                 Final score
Final score  points   MIPS adjustment  Final score  points  MIPS adjustment        points        MIPS adjustment
----------------------------------------------------------------------------------------------------------------
0.0-0.75...........  Negative 4%.....  0.0-3.75...........  Negative 5%....  0.0-7.5...........  Negative 7%.
0.76-2.99..........  Negative MIPS     3.76-14.99.........  Negative MIPS    7.51-29.99........  Negative MIPS
                      payment                                payment                              payment
                      adjustment                             adjustment                           adjustment
                      greater than                           greater than                         greater than
                      negative 4% and                        negative 5%                          negative 7%
                      less than 0% on                        and less than                        and less than
                      a linear                               0% on a linear                       0% on a linear
                      sliding scale.                         sliding scale.                       sliding scale.
3.00...............  0% adjustment...  15.0...............  0% adjustment..  30.0..............  0% adjustment.
3.01-69.99.........  Positive MIPS     15.01-69.99........  Positive MIPS    30.01-79.99.......  Positive MIPS
                      payment                                payment                              payment
                      adjustment                             adjustment                           adjustment
                      greater than 0%                        greater than                         greater than
                      on a linear                            0% on a linear                       0% on a linear
                      sliding scale.                         sliding scale.                       sliding scale.
                      The linear                             The linear                           The linear
                      sliding scale                          sliding scale                        sliding scale
                      ranges from 0                          ranges from 0                        ranges from 0
                      to 4% for                              to 5% for                            to 7% for
                      scores from                            scores from                          scores from
                      3.00 to 100.00.                        15.00 to                             30.00 to
                                                             100.00.                              100.00.
                     This sliding                           This sliding                         This sliding
                      scale is                               scale is                             scale is
                      multiplied by a                        multiplied by                        multiplied by
                      scaling factor                         a scaling                            a scaling
                      greater than                           factor greater                       factor greater
                      zero but not                           than zero but                        than zero but
                      exceeding 3.0                          not exceeding                        not exceeding
                      to preserve                            3.0 to                               3.0 to
                      budget                                 preserve                             preserve
                      neutrality.                            budget                               budget
                                                             neutrality.                          neutrality.
70.0-100...........  Positive MIPS     70.0-100...........  Positive MIPS    80.0-100..........  Positive MIPS
                      payment                                payment                              payment
                      adjustment                             adjustment                           adjustment
                      greater than 0%                        greater than                         greater than
                      on a linear                            0% on a linear                       0% on a linear
                      sliding scale.                         sliding scale.                       sliding scale.
                      The linear                             The linear                           The linear
                      sliding scale                          sliding scale                        sliding scale
                      ranges from 0                          ranges from 0                        ranges from 0
                      to 4% for                              to 5% for                            to 7% for
                      scores from                            scores from                          scores from
                      3.00 to 100.00.                        15.00 to                             30.00 to
                                                             100.00.                              100.00.
                     This sliding                           This sliding                         This sliding
                      scale is                               scale is                             scale is
                      multiplied by a                        multiplied by                        multiplied by
                      scaling factor                         a scaling                            a scaling
                      greater than                           factor greater                       factor greater
                      zero but not                           than zero but                        than zero but
                      exceeding 3.0                          not exceeding                        not exceeding
                      to preserve                            3.0 to                               3.0 to
                      budget                                 preserve                             preserve
                      neutrality.                            budget                               budget
                      PLUS.                                  neutrality.                          neutrality.
                                                             PLUS.                                PLUS.
                     An additional                          An additional                        An additional
                      MIPS payment                           MIPS payment                         MIPS payment
                      adjustment for                         adjustment for                       adjustment for
                      exceptional                            exceptional                          exceptional
                      performance.                           performance.                         performance.
                      The additional                         The additional                       The additional
                      MIPS payment                           MIPS payment                         MIPS payment
                      adjustment                             adjustment                           adjustment
                      starts at 0.5%                         starts at 0.5%                       starts at 0.5%
                      and increases                          and increases                        and increases
                      on a linear                            on a linear                          on a linear
                      sliding scale.                         sliding scale.                       sliding scale.
                      The linear                             The linear                           The linear
                      sliding scale                          sliding scale                        sliding scale
                      ranges from 0.5                        ranges from                          ranges from
                      to 10% for                             0.5 to 10% for                       0.5 to 10% for
                      scores from                            scores from                          scores from
                      70.00 to 100.00.                       70.00 to                             80.00 to
                                                             100.00.                              100.00.
                     This sliding                           This sliding                         This sliding
                      scale is                               scale is                             scale is
                      multiplied by a                        multiplied by                        multiplied by
                      scaling factor                         a scaling                            a scaling
                      not greater                            factor not                           factor not
                      than 1.0 in                            greater than                         greater than
                      order to                               1.0 in order                         1.0 in order
                      proportionately                        to                                   to
                      distribute the                         proportionatel                       proportionatel
                      available funds                        y distribute                         y distribute
                      for exceptional                        the available                        the available
                      performance.                           funds for                            funds for
                                                             exceptional                          exceptional
                                                             performance.                         performance.
----------------------------------------------------------------------------------------------------------------

    We have provided updated examples below for the 2021 MIPS payment 
year to demonstrate scenarios in which MIPS eligible clinicians can 
achieve a final score at or above the performance threshold of 30 
points for the 2021 MIPS payment year.
Example 1: MIPS Eligible Clinician in Small Practice Submits 1 Quality 
Measure and 1 Improvement Activity
    In the example illustrated in Table 54, a MIPS eligible clinician 
in a small practice reporting individually exceeds the performance 
threshold by reporting 1 quality measure via claims and performing at 
the highest level on the measure, for which the MIPS eligible clinician 
receives 10 measure achievement points, and reporting one medium-weight 
improvement activity. The practice does not submit data for the 
Promoting Interoperability performance category but does submit a 
significant hardship exception application which is approved; 
therefore, the weight for the Promoting Interoperability performance 
category is

[[Page 35980]]

redistributed to the quality performance category under the reweighting 
policies discussed in this proposed rule at section III.H.3.i.(2)(b). 
We note that this example is only intended to illustrate that small 
practices may be later adopters of CEHRT and that during the transition 
period there are opportunities to succeed while practices work towards 
CEHRT adoption and interoperability. We also assumed the small practice 
has a cost performance category percent score of 50 percent. Finally, 
we assumed a complex patient bonus of 3 points. There are several 
special scoring rules which affect MIPS eligible clinicians in a small 
practice:
     10 measure achievement points for the 1 quality measure 
submitted at the highest level of performance. We refer readers to this 
policy at Sec.  414.1380(b)(1). Because the measure is submitted via 
claims, it does not qualify for the end-to-end electronic reporting 
bonus, nor would it qualify for the high-priority bonus because it is 
the only measure submitted. Because the MIPS eligible clinician does 
not meet full participation requirements, the MIPS eligible clinician 
does not qualify for improvement scoring. However, because the 
clinician did submit a measure, the clinician is able to receive 3 
measure bonus points for the small practice bonus. Therefore, the 
quality performance category is (10 measure achievement points + 3 
measure bonus points)/60 total available measure points + zero 
improvement percent score which is 21.67 percent.
     The Promoting Interoperability performance category weight 
is redistributed to the quality performance category so that the 
quality performance category score is worth 70 percent of the final 
score. We refer readers to section III.H.3.i.(2)(b) of this proposed 
rule for a discussion of reweighting policies.
     MIPS eligible clinicians in small practices qualify for 
special scoring for improvement activities so a medium weighted 
activity is worth 20 points (instead of 10 points for MIPS eligible 
clinicians generally) out of a total of 40 possible points for the 
improvement activities performance category. We refer readers to Sec.  
414.1380(b)(3) for this policy.
     This MIPS eligible clinician exceeds the performance 
threshold of 30 points (but does not exceed the additional performance 
threshold). This score is summarized in Table 54.

                    Table 54--Scoring Example 1, MIPS Eligible Clinician in a Small Practice
----------------------------------------------------------------------------------------------------------------
                  [A]                                [B]                        [C]                    [D]
Performance category                     Performance score.........  Category weight..........     Earned points
                                                                                                    ([B] * [C] *
                                                                                                            100)
----------------------------------------------------------------------------------------------------------------
Quality................................  21.67%....................  70%......................             15.17
Cost...................................  50%.......................  15%......................               7.5
Improvement Activities.................  20 out of 40 points--50%..  15%......................               7.5
Promoting Interoperability.............  N/A.......................  0% (reweighted to                         0
                                                                      quality).
                                                                                               -----------------
    Subtotal (Before Bonus)............  ..........................  .........................             30.17
    Complex Patient Bonus..............  ..........................  .........................                 3
                                                                                               -----------------
        Final Score (not to exceed 100)  ..........................  .........................             33.17
----------------------------------------------------------------------------------------------------------------

Example 2: Group Submission Not in a Small Practice
    In the example illustrated in Table 55, a MIPS eligible clinician 
in a medium size practice participating in MIPS as a group receives 
performance category scores of 85 percent for the quality performance 
category, 50 percent for the cost performance category, 75 percent for 
the Promoting Interoperability, and 100 percent for the improvement 
activities performance categories. There are many paths for a practice 
to receive an 85 percent score in the quality performance category, so 
for simplicity we are assuming the score has been calculated at this 
amount. The final score is calculated to be 82.5, and both the 
performance threshold of 30 and the additional performance threshold of 
80 are exceeded. Again, for simplicity, we assume a complex patient 
bonus of 3 points. In this example, the group practice does not qualify 
for any special scoring, yet is able to exceed the additional 
performance threshold and will receive the additional MIPS payment 
adjustment factor.

                    Table 55--Scoring Example 2, MIPS Eligible Clinician in a Medium Practice
----------------------------------------------------------------------------------------------------------------
                     [A]                                    [B]                      [C]               [D]
Performance category                          Performance score.............   Category weight     Earned points
                                                                                                    ([B] * [C] *
                                                                                                            100)
----------------------------------------------------------------------------------------------------------------
Quality.....................................  85%...........................               45%             38.25
Cost........................................  50%...........................               15%               7.5
Improvement Activities......................  40 out of 40 points--100%.....               15%                15
Promoting Interoperability..................  75%...........................               25%             18.75
                                                                             -----------------------------------
    Subtotal (Before Bonus).................  ..............................  ................              79.5
    Complex Patient Bonus...................  ..............................  ................                 3
                                                                             -----------------------------------
        Final Score (not to exceed 100).....  ..............................  ................              82.5
----------------------------------------------------------------------------------------------------------------


[[Page 35981]]

Example 3: Non-Patient Facing MIPS Eligible Clinician
    In the example illustrated in Table 56, an individual MIPS eligible 
clinician that is non-patient facing and not in a small practice 
receives performance category scores of 50 percent for the quality 
performance category, 50 percent for the cost performance category, and 
50 percent for 1 medium-weighted improvement activity. Again, there are 
many paths for a practice to receive a 50 percent score in the quality 
performance category, so for simplicity we are assuming the score has 
been calculated. Because the MIPS eligible clinician is non-patient 
facing, they qualify for special scoring for improvement activities and 
receive 20 points (out of 40 possible points) for each medium weighted 
activity Also, this individual did not submit Promoting 
Interoperability performance category measures and qualifies for the 
automatic redistribution of the Promoting Interoperability performance 
category weight to the quality performance category. Again, for 
simplicity, we assume a complex patient bonus of 3 points.
    In this example, the final score is 53 and the performance 
threshold of 30 is exceeded while the additional performance threshold 
of 80 is not.

                     Table 56--Scoring Example 3, Non-Patient Facing MIPS Eligible Clinician
----------------------------------------------------------------------------------------------------------------
                  [A]                                [B]                        [C]                    [D]
Performance category                     Performance score.........  Category weight..........     Earned points
                                                                                                    ([B] * [C] *
                                                                                                            100)
----------------------------------------------------------------------------------------------------------------
Quality................................  50%.......................  70%......................                35
Cost...................................  50%.......................  15%......................               7.5
Improvement Activities.................  20 out of 40 points for 1   15%......................               7.5
                                          medium weight activity--
                                          50%.
Promoting Interoperability.............  0%........................  0% (reweighted to                         0
                                                                      quality).
                                                                                               -----------------
    Subtotal (Before Bonus)............  ..........................  .........................                50
    Complex Patient Bonus..............  ..........................  .........................                 3
                                                                                               -----------------
        Final Score (not to exceed 100)  ..........................  .........................                53
----------------------------------------------------------------------------------------------------------------

    We note that these examples are not intended to be exhaustive of 
the types of participants nor the opportunities for reaching and 
exceeding the performance threshold.
k. Third Party Intermediaries
    We refer readers to Sec.  414.1400 and the CY 2018 Quality Payment 
Program final rule (82 FR 53806 through 53819) for our previously 
established policies regarding third party intermediaries.
    In this proposed rule, we are proposing to: (1) Define third party 
intermediary and require third party intermediaries to be based in the 
U.S.; (2) update certification requirements for data submission; (3) 
update the definition of Qualified Clinical Data Registry (QCDR); 
revise the self-nomination period for QCDRs; update of information 
required for QCDRs at the time of self-nomination; update consideration 
criteria for approval of QCDR measures; define the topped out timeline 
for QCDR measures; (4) revise the self-nomination period for qualified 
registries; (5) define health IT vendor; (6) update the definition, 
criteria, and requirements for CMS-approved survey vendor; auditing 
criteria; and (7) revising probation and disqualification criteria. As 
we continue our efforts to provide flexible and meaningful reporting 
options for MIPS eligible clinicians and groups, we will expound on the 
requirements and functions of a third party intermediary.
(1) Third Party Intermediaries Definition
    At Sec.  414.1305, we are proposing a new definition to define a 
third party intermediary as an entity that has been approved under 
Sec.  414.1400 to submit data on behalf of a MIPS eligible clinician, 
group, or virtual group for one or more of the quality, improvement 
activities, and Promoting Interoperability performance categories. A 
QCDR, qualified registry, health IT vendor, or CMS-approved survey 
vendor are considered third party intermediaries. We are also proposing 
to change the section heading at Sec.  414.1400 from ``Third party data 
submissions'' to ``Third party intermediaries'' to elucidate the 
definition and function of a third party intermediary.
    We have received inquiries from stakeholders regarding the ability 
of a non-U.S. based third party intermediary to participate in MIPS. 
CMS IT systems are required to adhere to multiple agency and federal 
security standards and policy. CMS policy prohibits non-U.S. citizens 
from accessing CMS IT systems, and also requires all CMS program data 
to be retained in accordance with U.S. Federal policy, specifically 
National Institute of Standards and Technology (NIST) Special 
Publication (SP) 800-63, which outlines enrollment and identity 
proofing requirements (levels of assurance) for federal IT system 
access. Access to the Quality Payment Program would necessitate passing 
a remote or in-person Federated Identity Proofing process (that is, 
Equifax or equivalent). A non-U.S. based third party intermediary's 
potential lack of a SSN, TIN, U.S. based address, and other elements 
required for identity proofing and identity verification would impact 
their ability to pass the necessary background checks. An inability to 
pass identity proofing may limit or fully deny access to the Quality 
Payment Program if the intent is to interact with the Quality Payment 
Program outside of the U.S. for the purposes of reporting and storing 
data.
    We would like to emphasize that these requirements are all tied to 
existing federal policy which is applicable to all HHS/CMS FISMA 
systems and assets and are not Quality Payment Program specific. More 
information on these policies is available here: HHS Information 
Security and Privacy Policy (IS2P) (https://www.hhs.gov/about/agencies/asa/ocio/cybersecurity/); CMS Information Systems Security 
and Privacy Policy (IS2P2) (https://www.cms.gov/Research-Statistics-
Data-and-Systems/CMS-Information-Technology/InformationSecurity/Info-
Security-Library-Items/CMS-

[[Page 35982]]

Information-Systems-Security-and-Privacy-Policy-IS2P2.html); OMB 
Memorandum 04-04, E-Authentication Guidance for Federal Agencies 
(https://georgewbush-whitehouse.archives.gov/omb/memoranda/fy04/m04-04.pdf); and NIST SP 800-63 Digital Identity Guidelines (https://pages.nist.gov/800-63-3/). Therefore, we propose to amend previously 
finalized policies at Sec.  414.1400(a)(4) to indicate that a third 
party intermediary's principle place of business and retention of 
associated CMS data must be within the U.S.
    We would like to note that third party intermediaries that are 
authorized by us to submit data on behalf of MIPS eligible clinicians, 
groups or virtual groups have not otherwise been evaluated for the 
capabilities, quality, or any other features or its products. The 
United States Government and CMS do not endorse or recommend any third 
party intermediary or its products. Prior to selecting or using any 
third party intermediary or its products, MIPS eligible clinicians, 
groups or virtual groups should perform their own due diligence on the 
entity and its products, including contacting the entity directly to 
learn more about its products.
(2) Certification
    We previously finalized in the CY 2018 Quality Payment Program 
final rule (82 FR 53807) at Sec.  414.1400(a)(5), that all data 
submitted to us by a third party intermediary on behalf of a MIPS 
eligible clinician, group or virtual group must be certified by the 
third party intermediary to the best of its knowledge as true, 
accurate, and complete; and that this certification must occur at the 
time of the submission and accompany the submission. We have discovered 
it is not operationally feasible to require certification at the time 
of submission, or to require that the certification accompany the 
submission, for submission types by third party intermediaries, 
including data via direct, login and upload, login and attest, CMS Web 
Interface or Medicare Part B claims. We refer readers to section 
III.H.3.h of this proposed rule for our proposed modifications to the 
previously established data submission terminology. In order to address 
these various submission types that are currently available, we are 
proposing to amend Sec.  414.1400(a)(5) to state that all data 
submitted to CMS by a third party intermediary must be certified as 
true, accurate, and complete to the best of its knowledge and that such 
certification must be made in a form and manner and at such time as 
specified by CMS.
(3) Qualified Clinical Data Registries (QCDRs)
    We refer readers to Sec.  414.1400 and the CY 2018 Quality Payment 
Program final rule (82 FR 53807 through 53815) for our previously 
finalized policies regarding QCDRs. In this proposed rule, we are 
proposing to update: The definition of QCDR, the self-nomination period 
for QCDRs, information required for QCDRs at the time of self-
nomination, and consideration of criteria for approval of QCDR 
measures.
(a) Proposed Update to the Definition of a QCDR
    At Sec.  414.1305 and in the CY 2017 Quality Payment Program final 
rule (81 FR 77363 through 77364), we finalized the definition of a QCDR 
to be a CMS-approved entity that has self-nominated and successfully 
completed a qualification process to determine whether the entity may 
collect medical or clinical data for the purpose of patient and disease 
tracking to foster improvement in the quality of care provided to 
patients.
    We want to ensure that QCDRs that participate in MIPS have access 
to clinical expertise in quality measurement and are able to provide 
and demonstrate an understanding of the clinical medicine, evidence-
based gaps in care, and opportunities for improvement in the quality of 
care delivered to patients and priorities that are important to MIPS 
eligible clinicians. From our experiences with QCDRs to date, we have 
discovered that certain entities that have a predominantly technical 
background with limited understanding of medical quality metrics or the 
process for developing quality measures are seeking approval as a QCDR. 
We recognize the importance of these organizations' expertise within 
the Quality Payment Program; however, we do not believe that these 
types of entities, in the absence of clinical expertise in quality 
measurement, meet the intent of QCDRs. Specifically, we are concerned 
that the QCDR measures submitted by such entities for approval have not 
undergone the same consensus development, scientific rigor, and 
clinical assessment that is needed for developing measures, compared to 
those QCDR measures that are developed by specialty societies and other 
entities with clinical expertise.
    We refer readers to the CMS Quality Measure Development Plan at 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/Final-MDP.pdf for 
more information regarding the measure development process. While we 
have encouraged the participation of entities as QCDRs, during the past 
two iterations of the self-nomination period, a large number of 
entities that do not have the necessary clinical expertise to foster 
quality improvement have self-nominated or indicated their interest in 
becoming QCDRs. In reviewing previous QCDR measure submissions during 
the self-nomination and QCDR measure review and approval cycles in 
MIPS, we have observed that some entities were developing QCDR measures 
without a complete understanding of measure constructs (such as what is 
required of a composite measure or what it means to risk-adjust), and 
in some instances, QCDRs were developing QCDR measures in clinical 
areas in which they did not have expertise. We believe that with the 
increasing interest in QCDR development, it is important to ensure that 
QCDRs that participate in MIPS are first and foremost in business to 
improve the quality of care clinicians provide to their patients 
through quality measurement and/or disease tracking. An added benefit 
for QCDR participants is providing reliable quality reporting options 
for quality reporting programs for clinicians and specialists. 
Therefore, beginning with the 2022 MIPS payment year, we propose to 
amend Sec.  414.1305 to modify the definition of a QCDR to state that 
the approved entity must have clinical expertise in medicine and 
quality measure development. As a part of the self-nomination process, 
we would look for entities that have quality improvement expertise and 
a clinical background. We would also follow up with the entity via, for 
example, email or teleconference, should we question whether or not our 
standards are met. Specifically, a QCDR would be defined as an entity 
with clinical expertise in medicine and in quality measurement 
development that collects medical or clinical data on behalf of a MIPS 
eligible clinician for the purpose of patient and disease tracking to 
foster improvement in the quality of care provided to patients. In 
addition, under Sec.  414.1400(b)(2)(ii), an entity that uses an 
external organization for purposes of data collection, calculation, or 
transmission may meet the definition of a QCDR as long as the entity 
has a signed, written agreement that specifically details the 
relationship and responsibilities of the entity with the external 
organization effective as of September 1 the year prior to the year for 
which the entity seeks to become a QCDR. Thus, we expect entities 
without clinical expertise in medicine and

[[Page 35983]]

quality measure development that want to become QCDRs would collaborate 
or align with entities with such expertise in accordance with Sec.  
414.1400(b)(2)(ii). However, such entities may seek to qualify as 
another type of third party intermediary, such as a qualified registry. 
Becoming a registry does not require the level of measure development 
expertise that is needed to be a QCDR that develops measures.
(b) Establishment of an Entity Seeking To Qualify as a QCDR
    In the CY 2017 Quality Payment Program final rule (81 FR 77364), we 
require at Sec.  414.1400 (c)(2) that the QCDR must have at least 25 
participants by January 1 of the performance period. These participants 
do not need to use the QCDR to report MIPS data to us; rather, they 
need to submit data to the QCDR for quality improvement. We realize 
that a QCDR's lack of preparedness to accept data from MIPS eligible 
clinicians and groups beginning on January 1 of the performance period 
may negatively impact a clinician's ability to use a QCDR to report, 
monitor the quality of care they provide to their patients (and act on 
these results) and may inadvertently increase clinician burden. For 
these reasons, we are proposing to redesignate Sec.  414.1400 (c)(2) as 
Sec.  414.1400(b)(2)(i) to state that beginning with the 2022 MIPS 
Payment Year, the QCDR must have at least 25 participants by January 1 
of the year prior to the performance period. These participants do not 
need to use the QCDR to report MIPS data to us; rather, they need to 
submit data to the QCDR for quality improvement.
(c) Self-Nomination Process
    We refer readers to the CY 2018 Quality Payment Program final rule 
(82 FR 53808 through 53813) for our previously established policies 
regarding the simplified self-nomination process for existing QCDRs in 
MIPS that are in good standing and web-based submission of self-
nomination forms. We are not proposing any changes to those policies in 
this proposed rule; however, we are proposing to update: (1) The self-
nomination period; and (2) information required at the time of self-
nomination.
(i) Self-Nomination Period
    Under Sec.  414.1400(b), QCDRs must self-nominate from September 1 
of the year prior to the applicable performance period until November 1 
of the same year and must, among other things, provide all information 
requested by us at the time of self-nomination. As indicated in the CY 
2017 Quality Payment Program final rule (81 FR 77366), our goal has 
been to publish the list of approved QCDRs along with their approved 
QCDR measures prior to the beginning of the applicable performance 
period.
    We have received feedback from entities that have self-nominated to 
be a QCDR about the need for additional time to respond to requests for 
information during the review process, particularly with respect to 
QCDR measures that the entity intends to submit to us for the 
applicable performance period. In addition, based on our observations 
of the previous two self-nomination cycles, we anticipate an increase 
in the number of QCDR measure submissions for our review and 
consideration. For the transition year of MIPS, we received over 1,000 
QCDR measure submissions for review, and for the CY 2018 performance 
period, we received over 1,400 QCDR measure submissions. In order for 
us to process, review, and approve the QCDR measure submissions and 
provide QCDRs with sufficient time to respond to requests for 
information during the review process, while still meeting our goal to 
publish the list of approved QCDRs along with their approved QCDR 
measures prior to the start of the applicable performance period, we 
believe that an earlier self-nomination period is needed.
    Therefore, we are proposing to update the self-nomination period 
from September 1 of the year prior to the applicable performance period 
until November 1 to July 1 of the calendar year prior to the applicable 
performance period until September 1. Therefore, we are also proposing 
to amend Sec.  414.1400(b)(1) to provide that, beginning with the 2022 
MIPS payment year, entities seeking to qualify as QCDRs must self-
nominate during a 60-day period beginning on July 1 of the calendar 
year prior to the applicable performance period and ending on September 
1 of the same year; must provide all information required by us at the 
time of self-nomination; and must provide any additional information 
requested by us during the review process. For example, for the 2022 
MIPS payment year, the applicable performance period would be CY 2020, 
as discussed in section III.H.3.g. of this proposed rule. Therefore for 
the CY 2020 performance period, the self-nomination period would begin 
on July 1st, 2019 and end on September 1st, 2019, and we will make 
QCDRs aware of this through our normal communication channels. We 
believe that updating the self-nomination period would allow for 
additional review time and measure discussions with QCDRs.
(ii) Information Required at the Time of Self-Nomination
    We refer readers to the CY 2018 Quality Payment Program final rule 
(82 FR 53814), where we finalized that as a part of the self-nomination 
review and approval process for the CY 2018 performance period and 
future years, we will assign QCDR measure IDs to approved QCDR 
measures, and the same measure ID must be used by any other QCDRs that 
have received permission to also report the measure. We have received 
some questions from stakeholders as to whether the QCDR measure ID must 
be utilized or whether it is optional. As stated in the CY 2018 Quality 
Payment Program final rule, QCDRs, including any other QCDRs that have 
received permission to also report the measure, must use the CMS-
assigned QDCR measure ID. It is important that the CMS-assigned QCDR 
measure ID is posted and used accordingly, because without this ID we 
are not able to accurately identify and calculate the QCDR measures 
according to their specifications. Therefore, we propose to update 
Sec.  414.1400(b)(3)(iii) to state that QCDRs must include their CMS-
assigned QCDR measure ID number when posting their approved QCDR 
measure specifications, and also when submitting data on the QCDR 
measures to us.
(d) QCDR Measure Requirements
    We refer readers to the CY 2017 Quality Payment Program final rule 
(81 FR 77374 through 77375) for where we previously finalized standards 
and criteria used for selecting and approving QCDR measures. We 
finalized that QCDR measures must: Provide specifications for each 
measure, activity, or objective the QCDR intends to submit to CMS; and 
provide CMS descriptions and narrative specifications for each measure, 
activity, or objective no later than November 1 of the applicable 
performance period for which the QCDR wishes to submit quality measures 
or other performance category (improvement activities and Promoting 
Interoperability) data starting with the 2018 performance period and in 
future program years. We are proposing to consolidate our previously 
finalized standards and criteria used for selecting and approving QCDR 
measures at Sec.  414.1400(e) and (f) at Sec.  414.1400(b)(3). In this 
proposed rule, we are proposing to apply certain criteria used under 
the Call for Quality Measures Process when considering QCDR measures 
for possible

[[Page 35984]]

inclusion in MIPS beginning with the MIPS 2021 payment year.
    In the CY 2018 Quality Payment Program final rule (82 FR 53814), we 
noted our interest in elevating the standards for which QCDR measures 
are selected and approved for use and sought comment on whether the 
standards and criteria used for selecting and approving QCDR measures 
should be more closely aligned with those used for the Call for Quality 
Measures process described in the CY 2017 Quality Payment Program final 
rule (81 FR 77151). Some commenters expressed concern with this 
alignment, stating that the Call for Measures process is cumbersome, 
and would increase burden. Other commenters expressed the belief that 
the Call for Measures process does not recognize the uniqueness of 
QCDRs, and is not agile. We would like to clarify that our intention 
with any future alignment is to work towards consistent standards and 
evaluation criteria that would be applicable to all MIPS quality 
measures, including QCDR measures. We understand that some of the 
criteria under the Call for Measures process may be difficult for QCDRs 
to meet prior to submitting a particular measure for approval; however, 
we believe that the criteria under the Call for Measures process helps 
ensure that any new measures are reliable and valid for use in the 
program. Having a greater alignment in measure standards helps ensure 
that MIPS eligible clinicians and groups are able to select from an 
array of measures that are considered to be higher quality and provide 
meaningful measurement. As such, we believe that as we gain additional 
experience with QCDRs in MIPS, it would be appropriate to further align 
these criteria for QCDR measures with those of MIPS quality measures in 
future program years.
    Therefore, in addition to the QCDR measure criteria previously 
finalized at Sec.  414.1400(f), we are proposing to apply select 
criteria used under the Call for Measures Process, as described in the 
CY 2018 Quality Payment Program final rule (82 FR 53636). Specifically, 
in addition to the QCDR measure criteria at proposed Sec.  
414.1400(b)(3), we propose to apply the following criteria beginning 
with the 2021 MIPS payment year when considering QCDR measures for 
possible inclusion in MIPS:
     Measures that are beyond the measure concept phase of 
development.
     Preference given to measures that are outcome-based rather 
than clinical process measures.
     Measures that address patient safety and adverse events.
     Measures that identify appropriate use of diagnosis and 
therapeutics.
     Measures that address the domain for care coordination.
     Measures that address the domain for patient and caregiver 
experience.
     Measures that address efficiency, cost and resource use.
     Measures that address significant variation in 
performance.
    We believe that as we gain additional experience with QCDRs in 
MIPS, it would be appropriate to further align these criteria for QCDR 
measures with those of MIPS quality measures in future program years.
(e) QCDRs Seeking Permission From Another QCDR To Use an Existing, 
Approved QCDR Measure
    In the CY 2018 Quality Payment Program final rule (82 FR 53813), we 
finalized that beginning with the 2018 performance period and for 
future program years, QCDR vendors may seek permission from another 
QCDR to use an existing measure that is owned by the other QCDR. We 
intended for this policy to help reduce the number of QCDR measures 
that are similar in concept or clinical topic, or duplicative of other 
QCDR measures that are being approved. Furthermore, having multiple 
QCDRs report on the same QCDR measure allows for a larger cohort of 
clinicians to report on the measure, which helps establish more 
reliable benchmarks and may give some eligible clinicians or group a 
better chance of obtaining a higher score on a particular measure. 
However, we have experienced that this policy has created unintended 
financial burden for QCDRs requesting permission from other QCDRs who 
own QCDR measures, as some QCDRs charge a fee for the use of their QCDR 
measures. MIPS quality measures, while stewarded by specific specialty 
societies or organizations, are generally available for third party 
intermediaries, MIPS eligible clinicians, and groups to report on for 
purposes of MIPS without a fee for use. Similarly, we believe, that 
once a QCDR measure is approved for reporting in MIPS, it should be 
generally available for other QCDRs to report on for purposes of MIPS 
without a fee for use. We propose at Sec.  414.1400 (b)(3)(ii)(C) that 
beginning with the 2021 MIPS payment year, as a condition of a QCDR 
measure's approval for purposes of MIPS, the QCDR measure owner would 
be required to agree to enter into a license agreement with CMS 
permitting any approved QCDR to submit data on the QCDR measure 
(without modification) for purposes of MIPS and each applicable MIPS 
payment year. We also propose at Sec.  414.1400(b)(3)(iii) that other 
QCDRs would be required to use the same CMS-assigned QCDR measure ID. 
If a QCDR refuses to enter into such a license agreement, the QCDR 
measure would be rejected and another QCDR measure of similar clinical 
concept or topic may be approved in its place.
(4) Qualified Registries
    We refer readers to Sec.  414.1400 and the CY 2018 Quality Payment 
Program final rule (82 FR 53815 through 53818) for our previously 
finalized policies regarding qualified registries. In this rule, we are 
proposing to update: Information required for qualified registries at 
the time of self-nomination and the self-nomination period for 
qualified registries. This is discussed in more detail below.
(a) Establishment of an Entity Seeking To Qualify as a Qualified 
Registry
    In the CY 2017 Quality Payment Program final rule (81 FR 77383), we 
state at Sec.  414.1400(h)(2) that the qualified registry must have at 
least 25 participants by January 1 of the performance period. These 
participants do not need to use the qualified registry to report MIPS 
data to us; rather, they need to submit data to the qualified registry 
for quality improvement. We realize that a qualified registry's lack of 
preparedness to accept data from MIPS eligible clinicians and groups 
beginning on January 1 of the performance period may negatively impact 
a clinician's ability to use a Qualified Registry to report, monitor 
the quality of care they provide to their patients (and act on these 
results) and may inadvertently increase clinician burden. For these 
reasons, we are proposing to redesignate Sec.  414.1400(h)(2) as Sec.  
414.1400(c)(2) to state that beginning with the 2022 MIPS Payment Year, 
the qualified registry must have at least 25 participants by January 1 
of the year prior to the applicable performance period. These 
participants do not need to use the qualified registry to report MIPS 
data to us; rather, they need to submit data to the qualified registry 
for quality improvement.
(b) Self-Nomination Process
    We refer readers to Sec.  414.1400(g), the CY 2017 and CY 2018 
Quality Payment Program final rules (81 FR 77383 and 82 FR 53815, 
respectively) for our previously established policies regarding the 
self-nomination process for qualified registries. We are not proposing 
any changes to this policy.

[[Page 35985]]

(c) Self-Nomination Period
    Under the previously finalized policy at Sec.  414.1400(g), 
qualified registries must self-nominate from September 1 of the year 
prior to the applicable performance period until November 1 of the same 
year and must, among other things, provide all information requested by 
us at the time of self-nomination. To maintain alignment with the 
timelines proposed for QCDR self-nomination, as discussed in section 
III.H.3.k.(3)(c) above, we are also proposing to update the self-
nomination period from September 1 of the year prior to the applicable 
performance period until November 1 to July 1 of the calendar year 
prior to the applicable performance period until September 1. 
Specifically, we are proposing at Sec.  414.1400(c)(1) that, beginning 
with the 2022 MIPS payment year, entities seeking to qualify as 
qualified registries must self-nominate during a 60-day period 
beginning on July 1 of the calendar year prior to the applicable 
performance period and ending on September 1 of the same year; must 
provide all information required by us at the time of self-nomination; 
and must provide any additional information requested by us during the 
review process. For example, for the 2022 MIPS payment year, the 
applicable performance period would be CY 2020, as discussed in section 
III.H.3.g. of this proposed rule. Therefore, the self-nomination period 
for qualified registries would begin on July 1, 2019 and end on 
September 1, 2019.
(5) Health IT Vendors or Other Authorized Third Parties That Obtain 
Data From MIPS Eligible Clinicians' Certified EHR Technology (CEHRT)
    We refer readers to Sec.  414.1400 and the CY 2017 Quality Payment 
Program final rule (81 FR 77377 through 77382) for our previously 
finalized policies regarding health IT vendors or other authorized 
third parties that obtain data from MIPS eligible clinicians. We 
finalized that health IT vendors that obtain data from a MIPS eligible 
clinician, like other third party intermediaries, would have to meet 
all criteria designated by us as a condition of their qualification or 
approval to participate in MIPS as a third party intermediary. This 
includes submitting data in the form and manner specified by us. We 
propose to codify these policies at Sec.  414.1400(d). Although we 
specified criteria for a health IT vendor in the CY 2017 Quality 
Payment Program final rule, we failed to codify the definition of a 
health IT vendor. Therefore, in this proposed rule, we are proposing to 
define at Sec.  414.1305, that health IT vendor means an entity that 
supports the health IT requirements on behalf of a MIPS eligible 
clinician (including obtaining data from a MIPS eligible clinician's 
CEHRT).
    As indicated in footnote 1 of the CY 2017 Quality Payment Program 
final rule (81 FR 77014 through 77015), the term ``health IT vendor'' 
encompasses many types of entities that support the health IT 
requirements on behalf of a MIPS eligible clinician. A ``health IT 
vendor'' may or may not also be a ``health IT developer'' for the 
purposes of the ONC Health IT Certification Program (Program), and, in 
some cases, the developer and the vendor of a single product may be 
different entities. Under the Program, a health IT developer 
constitutes a vendor, self-developer, or other entity that presents 
health IT for certification or has health IT certified under the 
Program. Other health IT vendors may maintain a range of data 
transmission, aggregation, and calculation services or functions, such 
as organizations which facilitate health information exchange.
(6) CMS-Approved Survey Vendors
    In the CY 2017 Quality Payment Program final rule (81 FR 77386), we 
finalized the criteria, required forms, and vendor business 
requirements needed to participate in MIPS as a CMS-approved survey 
vendor. In this proposed rule, we are proposing at Sec.  414.1400(e) to 
codify these previously finalized criteria and requirements. 
Accordingly, we propose that Sec.  414.1400(e) would state that 
entities seeking to be a CMS-approved survey vendor for any MIPS 
performance period must submit a survey vendor application to CMS in a 
form and manner specified by CMS for each MIPS performance period for 
which it wishes to transmit such data. The application and any 
supplemental information requested by CMS must be submitted by 
deadlines specified by CMS. We propose that a CMS-approved survey 
vendor must meet several criteria. First, an entity must have 
sufficient experience, capability, and capacity to accurately report 
CAHPS data, including:
     At least 3 years of experience administering mixed-mode 
surveys (surveys that employ multiple modes to collect data) that 
include mail survey administration followed by survey administration 
via Computer Assisted Telephone Interview (CATI);
     At least 3 years of experience administering surveys to a 
Medicare population;
     At least 3 years of experience administering CAHPS surveys 
within the past 5 years;
     Experience administering surveys in English and one of the 
following languages: Cantonese, Korean, Mandarin, Russian, or 
Vietnamese;
     Use of equipment, software, computer programs, systems, 
and facilities that can verify addresses and phone numbers of sampled 
beneficiaries, monitor interviewers, collect data via CATI, 
electronically administer the survey and schedule call-backs to 
beneficiaries at varying times of the day and week, track fielded 
surveys, assign final disposition codes to reflect the outcome of data 
collection of each sampled case, and track cases from mail surveys 
through telephone follow-up activities; and
     Employ a program manager, information systems specialist, 
call center supervisor and mail center supervisor to administer the 
survey.
    Furthermore, we propose that to be a CMS-approved survey vendor, 
the entity must also meet the following criteria: It must have 
certified that it has the ability to maintain and transmit quality data 
in a manner that preserves the security and integrity of the data; the 
entity must have successfully completed, and required its 
subcontractors to successfully complete, vendor training(s) 
administered by CMS or its contractors; the entity must have submitted 
a quality assurance plan and other materials relevant to survey 
administration, as determined by CMS, including cover letters, 
questionnaires and telephone scripts; the entity must have agreed to 
participate and cooperate, and have required its subcontractors to 
participate and cooperate, in all oversight activities related to 
survey administration conducted by CMS or its contractors; and the 
entity must have sent an interim survey data file to CMS that 
establishes the entity's ability to accurately report CAHPS data.
    We also refer readers to the CY 2018 Quality Payment Program final 
rule (82 FR 53818 through 53819) for our previously established 
policies regarding the updated survey vendor application deadline.
(7) Auditing of Third Party Intermediaries Submitting MIPS Data
    In the CY 2018 Quality Payment Program final rule (82 FR 53819), we 
established policies regarding auditing of third party intermediaries 
submitting MIPS data. In this proposed rule, we are not proposing any 
changes to these policies.

[[Page 35986]]

(8) Remedial Action and Termination of Third Party Intermediaries
    In the CY 2017 Quality Payment Program final rule (81 FR 77548), we 
finalized the criteria for probation and disqualification for third 
party intermediaries at Sec.  414.1400(k). In this proposed rule, we 
are proposing to revise the numbering of this section and the title to 
more accurately describe the policies in this section. Thus, we propose 
to renumber this section as Sec.  414.1400(f) and to rename it as 
``remedial action and termination of third party intermediaries.'' 
Additionally, we are proposing changes to Sec.  414.1400(f) to amend, 
clarify, and streamline our policies related to remedial action and 
termination.
    Our intent with these policies is to identify noncompliance with 
the applicable third party intermediary criteria, as well as identify 
issues that may impact the accuracy of or our ability to use the data 
submitted by third party intermediaries. Accordingly, we propose to 
amend Sec.  414.1400(f)(1) to state that we may take remedial action 
for noncompliance with applicable third party intermediary criteria for 
approval (a deficiency) or for the submission of inaccurate, unusable, 
or otherwise compromised data. In the CY 2017 Quality Payment Program 
final rule, we finalized our policy regarding data inaccuracies at 
Sec.  414.1400(k)(4). We are proposing at Sec.  414.1400(f)(3) to 
expand data inaccuracies to include a determination by us that data is 
inaccurate, unusable, or otherwise compromised. However, we are not 
proposing to change the factors we may consider to make such a 
determination. We also propose to move the notification requirement at 
Sec.  414.1400(k)(6) to Sec.  414.1400(f)(1) and to apply the 
requirement to all deficiencies and data errors.
    Based on our early experience with third party intermediaries under 
MIPS and the challenges for both third party intermediaries and us in 
regards to timing and trying to resolve deficiencies and data errors 
within the various reporting and performance periods, we propose to 
amend the timeframes by which a third party intermediary must submit a 
Corrective Action Plan (CAP) to us or come into compliance. 
Specifically, we propose Sec.  414.1400(f)(2), which requires third 
party intermediaries to submit a CAP or correct the deficiencies or 
data errors by the date specified by us.
    Additionally, we propose to consolidate the grounds by which we can 
take remedial action against a third party intermediary found at Sec.  
414.1400(k)(1) and (4) into Sec.  414.1400(f)(1), as well as the 
grounds by which we can terminate a third party intermediary found at 
Sec.  414.1400(k)(3), (5) and (7) into Sec.  414.1400(f)(2). Therefore, 
we propose at Sec.  414.1400(f)(1) that if at any time we determine 
that a third party intermediary has ceased to meet one or more of the 
applicable criteria for approval, or has submitted data that is 
inaccurate, unusable, or otherwise compromised, we may take certain 
remedial actions (for example, request a Corrective Action Plan (CAP)). 
In addition, we propose at Sec.  414.1400(f)(2) that we may terminate, 
immediately or with advance notice, the ability of a third party 
intermediary to submit MIPS data on behalf of a MIPS eligible 
clinician, group, or virtual group for one or more of the following 
reasons: We have grounds to impose remedial action, we have not 
received a CAP within the specified time period or the CAP is not 
accepted by us, or the third party intermediary fails to correct the 
deficiencies or data errors by the data specified by us.
    Finally, we propose to consolidate the actions we may take if we 
identify a deficiency or data error that are set forth at Sec.  
414.1400(k)(3) and (7) into Sec.  414.1400(f)(1). Thus, we propose at 
Sec.  414.1400(f)(1) that if we determine a third party intermediary 
has ceased to meet one or more of the applicable criteria for approval, 
or has submitted data that is inaccurate, unusable, or otherwise 
compromised, we may require the third party intermediary to submit a 
CAP to us to address the identified deficiencies or data issue, 
including the actions it will take to prevent the deficiencies or data 
issues from recurring. The CAP must be submitted to CMS by a date 
specified by CMS. We propose that CMS may determine that submitted data 
is inaccurate, unusable, or otherwise compromised if the submitted 
data: (1) Includes, without limitation, TIN/NPI mismatches, formatting 
issues, calculation errors, or data audit discrepancies; and (2) 
affects more than three percent (but less than 5 percent) of the total 
number of MIPS eligible clinicians or group for which data was 
submitted by the third party intermediary. In addition, we propose that 
if the third party intermediary has a data error rate of 3 percent or 
more, we will publicly disclose the entity's data error rate on the CMS 
website until the data error rate falls below 3 percent.
    We also propose to amend Sec.  414.1400(k) by removing our 
probation policy. Therefore, we propose to remove the definition of 
probation at Sec.  414.1400(k)(2) and references to probation in Sec.  
414.1400(k)(1), (3) and (5).
1. Public Reporting on Physician Compare
    This section contains our proposed policies for public reporting on 
Physician Compare for year 3 of the Quality Payment Program (2019 data 
available for public reporting in late 2020) and future years, 
including MIPS, APMs, and other information as required by the MACRA 
and building on our previously finalized public reporting policies (see 
82 FR 53819 through 53832).
    Physician Compare (https://www.medicare.gov/physiciancompare) draws 
its operating authority from section 10331(a)(1) of the Affordable Care 
Act. Consistent with section 10331(a)(2) of the Affordable Care Act, 
Physician Compare initiated a phased approach to publicly reporting 
performance scores that provide comparable information on quality and 
patient experience measures. A complete history of public reporting on 
Physician Compare is detailed in the CY 2016 PFS final rule (80 FR 
71117 through 71122). More information about Physician Compare, 
including the history of public reporting and regular updates about 
what information is currently available, can also be accessed on the 
Physician Compare Initiative website at https://www.cms.gov/medicare/quality-initiatives-patient-assessment-instruments/physician-compare-initiative/.
    As discussed in the CY 2018 Quality Payment Program final rule (82 
FR 53820), Physician Compare has continued to pursue a phased approach 
to public reporting under the MACRA in accordance with section 
1848(q)(9) of the Act. Generally, all data available for public 
reporting on Physician Compare must meet our established public 
reporting standards under Sec.  414.1395(b). In addition, for each 
program year, CMS provides a 30-day preview period for any clinician or 
group with Quality Payment Program data before the data are publicly 
reported on Physician Compare under Sec.  414.1395(d). All data 
available for public reporting--measure rates, scores, and 
attestations, objectives, etc.--are available for review and correction 
during the targeted review process. See the CY 2018 Quality Payment 
Program final rule for details on this process (82 FR 53820).
    Lastly, section 104(e) of the MACRA requires the Secretary to make 
publicly available, on an annual basis, in an easily understandable 
format, information for physicians and, as

[[Page 35987]]

appropriate, other eligible clinicians related to items and services 
furnished to Medicare beneficiaries under Title XVIII of the Act. In 
accordance with section 104(e) of the MACRA, we finalized a policy in 
the CY 2016 PFS final rule (80 FR 71131) to add utilization data to the 
Physician Compare downloadable database.
    We believe section 10331 of the Affordable Care Act supports the 
overarching goals of the MACRA by providing the public with performance 
information that will help them make informed decisions about their 
health care, while encouraging clinicians to improve the quality of 
care they provide to their patients. In accordance with section 10331 
of the Affordable Care Act, section 1848(q)(9) of the Act, and section 
104(e) of the MACRA, we plan to continue to publicly report performance 
information on Physician Compare. As such, the following sections 
discuss the information previously finalized for inclusion on Physician 
Compare for all program years, as well as our proposed policies for 
public reporting on Physician Compare for year 3 of the Quality Payment 
Program (2019 data available for public reporting in late 2020) and 
future years.
(1) Final Score, Performance Categories, and Aggregate Information
    In the CY 2018 Quality Payment Program final rule (82 FR 53823), we 
finalized a policy to publicly report on Physician Compare, either on 
profile pages or in the downloadable database, the final score for each 
MIPS eligible clinician and the performance of each MIPS eligible 
clinician for each performance category, and to periodically post 
aggregate information on the MIPS, including the range of final scores 
for all MIPS eligible clinicians and the range of performance of all 
the MIPS eligible clinicians for each performance category, as 
technically feasible, for all future years. We will use statistical 
testing and user testing, as well as consultation with the Physician 
Compare Technical Expert Panel convened by our contractor, to determine 
how and where these data are best reported on Physician Compare.
    A summary of the previously finalized policies related to each 
performance category of MIPS data, as well as proposed policies for 
year 3 and future years, follows. It is important to note just because 
performance information is available for public reporting, it does not 
mean all data under all performance categories will be included on 
either public-facing profile pages or the downloadable database. These 
data must meet the public reporting standards, first. And, second, we 
are careful to ensure that we do not include too much information on 
public-facing profile pages in an effort not to overwhelm website 
users. Although all information submitted under MIPS is technically 
available for public reporting, we will continue our phased approach to 
making this information public.
(2) Quality
    In the CY 2018 Quality Payment Program final rule (82 FR 53824), we 
finalized a policy to make all measures under the MIPS quality 
performance category available for public reporting on Physician 
Compare, either on profile pages or in the downloadable database, as 
technically feasible. This includes all available measures across all 
collection types for both MIPS eligible clinicians and groups, for all 
future years. We will use statistical testing and website user testing 
to determine how and where measures are reported on Physician Compare. 
We will not publicly report first year quality measures, meaning any 
measure in its first year of use in the quality performance category, 
under Sec.  414.1395(c). We will also include the total number of 
patients reported on for each measure included in the downloadable 
database (82 FR 53824).
    We propose to modify Sec.  414.1395(b) to reference ``collection 
types'' instead of ``submission mechanisms'' to accurately update the 
terminology. We also propose to revise Sec.  414.1395(c) to indicate 
that we will not publicly report first year quality measures for the 
first 2 years a measure is in use in the quality performance category. 
We propose this change to encourage clinicians and groups to report new 
measures, get feedback on those measures, and learn from the early 
years of reporting measures before measure are made public. We request 
comment on these proposals.
(3) Cost
    In the CY 2018 Quality Payment Program final rule (82 FR 53825), we 
finalized a policy to include on Physician Compare a subset of cost 
measures that meet the public reporting standards at Sec.  414.1395(b), 
either on profile pages or in the downloadable database, if technically 
feasible, for all future years. This includes all available cost 
measures, and applies to both MIPS eligible clinicians and groups. We 
will use statistical testing and website user testing to determine how 
and where measures are reported on Physician Compare. We previously 
finalized that we will not publicly report first year cost measures, 
meaning any measure in its first year of use in the cost performance 
category, under Sec.  414.1395(c). Consistent with our proposal for 
first year quality measures, we propose to revise Sec.  414.1395(c) to 
indicate that we will not publicly report first year cost measures for 
the first 2 years a measure is in use in the cost performance category. 
We propose this change to help clinicians and groups get feedback on 
these measures and learn from the early years of these new measures 
being calculated before measure are made public. We request comment on 
this proposal.
(4) Improvement Activities
    In the CY 2018 Quality Payment Program final rule (82 FR 53826), we 
finalized a policy to include a subset of improvement activities 
information on Physician Compare, either on the profile pages or in the 
downloadable database, if technically feasible, for all future years. 
This includes all available activities reported via all available 
collection types, and applies to both MIPS eligible clinicians and 
groups. For those eligible clinicians and groups that successfully meet 
the improvement activities performance category requirements, this 
information will be posted on Physician Compare as an indicator. We 
also finalized for all future years to publicly report first year 
activities if all other public reporting criteria are satisfied.
(5) Promoting Interoperability (PI)
    In the CY 2018 Quality Payment Program final rule (82 FR 53827), we 
finalized a policy to include an indicator on Physician Compare for any 
eligible clinician or group who successfully meets the Promoting 
Interoperability performance category, as technically feasible, for all 
future years. ``Successful'' performance is defined as obtaining the 
base score of 50 percent (82 FR 53826). We also finalized a policy to 
include on Physician Compare, either on the profile pages or in the 
downloadable database, as technically feasible, additional information, 
including, but not limited to, objectives, activities, or measures 
specified in the CY 2018 Quality Payment Program final rule (82 FR 
53827; see 82 FR 53663 through 53688). This includes all available 
objectives, activities, or measures reported via all available 
collection types, and applies to both MIPS eligible clinicians and 
groups (82 FR 53827). We will use statistical testing and website user 
testing to determine how and where objectives, activities, and measures 
are reported on Physician Compare. We also

[[Page 35988]]

finalized for all future years to publicly report first year Promoting 
Interoperability objectives, activities, and measures if all other 
public reporting criteria are satisfied.
    In addition, we finalized that we will indicate ``high'' 
performance, as technically feasible and appropriate, in year 2 of the 
Quality Payment Program (2018 data available for public reporting in 
late 2019). ``High'' performance is defined as obtaining a score of 100 
percent (82 FR 53826 through 53827).
    As the Quality Payment Program progresses into year 3, and 
consistent with our work to simplify the requirements under the 
Promoting Interoperability performance category of MIPS, we are 
proposing not to include the indicator of ``high'' performance and to 
maintain only an indicator for ``successful'' performance in the 
Promoting Interoperability performance category beginning with year 2 
of the Quality Payment Program (2018 data available for public 
reporting in late 2019). Not including the ``high'' performance 
indicator while maintaining the ``successful'' performance indicator 
continues to provide useful information to patients and caregivers 
without burdening website users with the additional complexity of 
accurately differentiating between ``successful'' and ``high'' 
performance, as this proved difficult for users in testing. User 
testing to date shows that website users value this information 
overall, however, as they appreciate knowing clinicians and groups are 
effectively using EHR technology to improve care quality.
    We request comment on our proposal not to include the indicator for 
``high'' performance in the Promoting Interoperability performance 
category beginning with year 2 of the Quality Payment Program (2018 
data available for public reporting in late 2019).
    We are also seeking comment only on the type of EHR utilization 
performance information stakeholders would like CMS to consider adding 
to Physician Compare. This information would be considered for possible 
future inclusion on the website.
(6) Achievable Benchmark of Care (ABCTM)
    Benchmarks are important to ensuring that the quality data 
published on Physician Compare are accurately understood. A benchmark 
allows website users to more easily evaluate the information published 
by providing a point of comparison between groups and between 
clinicians. In the CY 2018 Quality Payment Program final rule (82 FR 
53829), we finalized a policy to use the Achievable Benchmark of Care 
(ABCTM) methodology to determine a benchmark for the 
quality, cost, improvement activities, and Promoting Interoperability 
data, as feasible and appropriate, by measure and collection type for 
each year of the Quality Payment Program based on the most recently 
available data each year. We also finalized a policy to use this 
benchmark as the basis of a 5-star rating for each available measure, 
as feasible and appropriate. For a detailed discussion of the 
ABCTM methodology, and more information about how this 
benchmark together with the equal ranges method is currently used to 
determine the 5-star rating system for Physician Compare, see the CY 
2018 Quality Payment Program final rule (82 FR 53827 through 53829). 
Additional information, including the Benchmark and Star Rating Fact 
Sheet, can be found on the Physician Compare Initiative website 
(https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/physician-compare-initiative/).
(a) Historical Data-Based Benchmarks
    Benchmarks, and the resulting star rating, are valuable tools for 
patients and caregivers to use to best understand the performance 
information included on Physician Compare. Benchmarks can also help the 
clinicians and groups reporting performance information understand 
their performance relative to their peers, and therefore, help foster 
continuous quality improvement. In the initial years of the Quality 
Payment Program, we anticipated year-to-year changes in the measures 
available. As noted, we previously finalized a policy to determine the 
benchmark using the most recently available data (82 FR 53829). This 
ensured that a benchmark could be calculated despite potential year-to-
year measure changes, but it also meant that the benchmark was not 
known to clinicians and groups prior to the performance period.
    By year 3 of the Quality Payment Program (2019 data available for 
public reporting in late 2020), we expect enough year-to-year stability 
in the measures available for reporting across all MIPS performance 
categories to use historical data to produce a reliable and 
statistically sound benchmark for most measures, by measure and 
collection type. Therefore, we are proposing to modify our existing 
policy to use the ABCTM methodology to determine benchmarks 
for the quality, cost, improvement activities, and Promoting 
Interoperability performance categories based on historical data, as 
feasible and appropriate, by measure and collection type beginning with 
year 3 of the Quality Payment Program (2019 data available for public 
reporting in late 2020). Specifically, benchmarks would be based on 
performance data from a baseline period or, if such data is not 
available, performance data from the performance period. The baseline 
period would be the 12-month calendar year that is 2 years prior to the 
applicable performance period. The benchmarks would be published prior 
to the start of the performance period, as technically feasible. For 
example, for the CY 2019 performance period, the benchmark developed 
using the ABCTM methodology would be calculated using CY 
2017 performance period data and would be published by the start of CY 
2019, as feasible and appropriate. If historical data is not available 
for a particular measure, we would indicate that and calculate the 
benchmark using performance data from the performance period. In this 
example, we would use CY 2019 performance period data to calculate the 
benchmark for CY 2019 performance period measures, as needed. This 
approach of utilizing historical data would be consistent with how the 
MIPS benchmarks are calculated for purposes of scoring the quality 
performance category. But, most importantly, this approach would 
provide eligible clinicians and groups with valuable information about 
the benchmark to meet to receive a 5-star rating on Physician Compare 
before data collection starts for the performance period. We request 
comment on this proposal.
(b) QCDR Measure Benchmarks
    Currently, only MIPS measures are star rated on Physician Compare. 
QCDR measures, as that term is used in Sec.  414.1400(e), are publicly 
reported as percent performance rates. As more QCDR measure data is 
available for public reporting, and appreciating the value of star 
rating the measures presented to website users, we believe star rating 
the QCDR measures will greatly benefit patients and caregivers as they 
work to make informed health care decisions. Particularly in the 
quality performance category, we believe that reporting all measure 
data in the same way will ease the burden of interpretation placed on 
site users and make the data more useful to them. Therefore, we are 
proposing to further modify our existing policy to extend the use of 
the ABCTM methodology and equal ranges method to determine, 
by measure and collection type, a benchmark and 5-star rating for QCDR 
measures, as that term is used in proposed Sec.  414.1400(b)(3), as 
feasible

[[Page 35989]]

and appropriate, using current performance period data in year 2 of the 
Quality Payment Program (2018 data available for public reporting in 
late 2019), and using historical benchmark data when possible as 
proposed above, beginning with year 3 of the Quality Payment Program 
(2019 data available for public reporting in late 2020). We request 
comment on this proposal.
(7) Voluntary Reporting
    In the CY 2018 Quality Payment Program final rule (82 FR 53830), we 
finalized a policy to make available for public reporting all data 
submitted voluntarily across all MIPS performance categories, 
regardless of collection type, by eligible clinicians and groups that 
are not subject to the MIPS payment adjustments, as technically 
feasible, for all future years. If an eligible clinician or group that 
is not subject to the MIPS payment adjustment chooses to submit data on 
quality, cost (if applicable), improvement activities, or Promoting 
Interoperability, these data are available for public reporting. We 
also finalized that during the 30-day preview period, these eligible 
clinicians and groups may opt out of having their data publicly 
reported on Physician Compare (82 FR 53830). If these eligible 
clinicians and groups do not opt out during the 30-day preview period, 
their data will be available for inclusion on Physician Compare if the 
data meet all public reporting standards at Sec.  414.1395(b).
(8) APM Data
    In the CY 2018 Quality Payment Program final rule (82 FR 53830), we 
finalized a policy to publicly report the names of eligible clinicians 
in Advanced APMs and the names and performance of Advanced APMs and 
APMs that are not considered Advanced APMs related to the Quality 
Payment Program, such as Track 1 Shared Savings Program Accountable 
Care Organizations (ACOs), as technically feasible, for all future 
years. We also finalized a policy to link clinicians and groups and the 
APMs they participate in on Physician Compare, as technically feasible.
4. Overview of the APM Incentive
a. Overview
    Section 1833(z) of the Act requires that an incentive payment be 
made to QPs for achieving threshold levels of participation in Advanced 
APMs. In the CY 2017 Quality Payment Program final rule (81 FR 77399 
through 77491), we finalized the following policies:
     Beginning in 2019, if an eligible clinician participated 
sufficiently in an Advanced APM during the QP Performance Period, that 
eligible clinician may become a QP for the year. Eligible clinicians 
who are QPs are excluded from the MIPS reporting requirements for the 
performance year and payment adjustment for the payment year.
     For years from 2019 through 2024, QPs receive a lump sum 
incentive payment equal to 5 percent of their prior year's estimated 
aggregate payments for Part B covered professional services. Beginning 
in 2026, QPs receive a higher update under the PFS for the year than 
non-QPs.
     For payment years 2019 and 2020, eligible clinicians may 
become QPs only through participation in Advanced APMs.
     For payment years 2021 and later, eligible clinicians may 
become QPs through a combination of participation in Advanced APMs and 
Other Payer Advanced APMs (which we refer to as the All-Payer 
Combination Option).
    In this proposed rule, we discuss proposals for clarifications and 
modifications to some of the policies that we previously finalized 
pertaining to Advanced APMs and the All-Payer Combination Option.
b. Terms and Definitions
    As we continue to develop the Quality Payment Program, we have 
identified the need to propose changes to some of the previously 
finalized definitions. A complete list of the original definitions is 
available in the CY 2017 Quality Payment Program final rule (81 FR 
77537 through 77540).
    In the CY 2018 Quality Payment Program final rule, in order to 
consolidate our regulations and avoid unnecessarily defining a term, we 
finalized removal of the defined term for ``Advanced APM Entity'' in 
Sec.  414.1305 and replaced instances of that term throughout the 
regulation with ``APM Entity.'' Similarly, we finalized replacing 
``Advanced APM Entity group'' with ``APM Entity group'' where it 
appears throughout our regulations (82 FR 53833). We noted that these 
changes were technical and had no substantive effect on our policies.
    To further consolidate our regulations and to clarify any potential 
ambiguity, we propose to modify the definition of Qualifying APM 
Participant (QP) at Sec.  414.1305 to provide that a QP is an eligible 
clinician determined by CMS to have met or exceeded the relevant QP 
payment amount or QP patient count threshold for the year based on 
participation in or with an APM Entity that is participating in an 
Advanced APM. The current definition of QP is based on an eligible 
clinician's participation in an Advanced APM Entity, which no longer is 
a defined term. Simply replacing the term ``Advanced APM Entity'' with 
the term ``APM Entity'' as finalized in the CY 2018 Quality Payment 
Program final rule does not fully convey the definition of QP because, 
as previously noted at 82 FR 53833, an APM Entity can participate in an 
APM that is, or is not, an Advanced APM; and QP status is attainable 
only through participation in an Advanced APM. Again we note that this 
proposed change is technical and would not have a substantive effect on 
our policies.
d. Advanced APMs
(1) Overview
    In the CY 2017 Quality Payment Program final rule (81 FR 77408), we 
finalized the criteria that define an Advanced APM based on the 
requirements set forth in sections 1833(z)(3)(C) and (D) of the Act. An 
Advanced APM is an APM that:
     Requires its participants to use certified EHR technology 
(CEHRT) (81 FR 77409 through 77414);
     Provides for payment for covered professional services 
based on quality measures comparable to measures under the quality 
performance category under MIPS (81 FR 77414 through 77418); and
     Either requires its participating APM Entities to bear 
financial risk for monetary losses that are in excess of a nominal 
amount, or is a Medical Home Model expanded under section 1115A(c) of 
the Act (81 FR 77418 through 77431). We refer to this criterion as the 
financial risk criterion.
(2) Use of CEHRT
(a) Overview
    In the CY 2017 Quality Payment Program final rule, we finalized 
that an Advanced APM must require at least 50 percent of eligible 
clinicians in each APM Entity to use CEHRT as defined at Sec.  414.1305 
to document and communicate clinical care with patients and other 
health care professionals. Further, we proposed but did not finalize an 
increase to the requirement wherein Advanced APMs must require 75 
percent CEHRT use in the subsequent year. Instead we maintained the 50 
percent CEHRT use requirement for the second performance year and 
beyond and indicated that we would consider making any potential 
changes through future rulemaking (81 FR 77412).
    As we move into the third year of the Quality Payment Program, we 
have prioritized interoperability which we consider to be health 
information

[[Page 35990]]

technology that enables the secure exchange of electronic health 
information with, and use of electronic health information from, other 
health information technology without special effort on the part of the 
user; allows for complete access, exchange, and use of all 
electronically accessible health information for authorized use under 
applicable law; and does not constitute information blocking as also 
defined by the 21st Century Cures Act. As such, we are committed to 
working with the ONC on implementation of the interoperability 
provisions of the 21st Century Cures Act. We also are exploring 
opportunities to incorporate these goals into the design of alternative 
payment models, wherever feasible and appropriate, to further promote 
the seamless and secure exchange of health information for clinicians 
and patients.
(b) Increasing the CEHRT Use Criterion for Advanced APMs
    We are now proposing that, beginning for CY 2019, in order to be an 
Advanced APM, the APM must require at least 75 percent of eligible 
clinicians in each APM Entity use CEHRT as defined at Sec.  414.1305 to 
document and communicate clinical care with patients and other health 
care professionals.
    According to data collected by ONC, since the CY 2017 Quality 
Payment Program final rule was published, EHR adoption has been 
widespread and we want to encourage continued adoption. Additionally, 
in response to the CY 2017 Quality Payment Program proposed rule 
stakeholders encouraged us to raise the CEHRT use criterion to 75 
percent (see 81 FR 77411). We believe that this proposed change aligns 
with the increased adoption of CEHRT among providers and suppliers that 
is already happening, and will encourage further CEHRT adoption. We 
further believe that most existing Advanced APMs already include 
provisions that would require participants to adhere to the level of 
CEHRT use specified in our regulations, and therefore this increase 
will not negatively impact the Advanced APM status of those APMs.
    We seek comment on this proposal.
(3) MIPS Comparable Quality Measures
(a) Overview
    In the CY 2017 Quality Payment Program final rule, we explained 
that one of the criteria for an APM to be an Advanced APM is that it 
must provide for payment for covered professional services based on 
quality measures comparable to measures under the performance category 
described in section 1848(q)(2)(A) of the Act, which is the MIPS 
quality performance category. We generally refer to these measures in 
the remainder of this discussion as ``MIPS-comparable quality 
measures.'' We also explained that we interpret this criterion to 
require the APM to incorporate quality measure results as a factor when 
determining payment to participants under the terms of the APM (81 FR 
77414).
    In the CY 2017 Quality Payment Program proposed rule, we proposed 
that to be an Advanced APM, an APM must base payment on quality 
measures that are evidence-based, reliable, and valid; and that at 
least one measure must be an outcome measure unless there is not an 
applicable outcome measure on the MIPS quality list at the time the APM 
is developed. The required outcome measure does not have to be one of 
those on the MIPS quality measure list. We did not specify that the 
outcome measure is required to be evidence-based, reliable, and valid. 
(81 FR 28302). We finalized these policies in the CY 2017 Quality 
Payment Program final rule and codified at Sec.  414.1415(b).
(b) General Quality Measures: Evidence-Based, Reliable, and Valid
    We considered a number of ways to implement the Advanced APM 
criterion that payment must be based on MIPS-comparable quality 
measures, as well as how to define which measures would reflect the 
statutory requirements to be ``comparable'' to MIPS quality measures. 
We explored options for defining MIPS-comparable quality measures, 
including: (1) Limiting comparable measures to those from the annual 
MIPS list of measures; and (2) including measures that have an 
evidence-based focus and are found to reliable and valid through 
measure testing. We concluded that while these potential approaches 
have merit, they may be overly restrictive for the variety of APMs, 
which are intended to have the flexibility to test new ways of paying 
for and delivering care (81 FR 28301 through 28302).
    In light of this, we finalized a framework for identifying MIPS-
comparable quality measures that was intended to reflect a few key 
principles: Specifically, that the measure framework would require 
measures with an evidence-based focus that are reliable and valid, 
while not being so restrictive as to limit the APMs from using new or 
innovative measures (81 FR 28302).
    Specifically, in the CY 2017 Quality Payment Program final rule, we 
codified at Sec.  414.1415(b)(2) that at least one of the quality 
measures upon which an Advanced APM bases the payment must have an 
evidence-based focus, be reliable, and valid, and meet at least one of 
the following criteria: Used in the MIPS quality performance category 
as described in Sec.  414.1330; endorsed by a consensus-based entity; 
developed under section 1848(s) of the Act; Submitted in response to 
the MIPS Call for Quality Measures under section 1848(q)(2)(D)(ii) of 
the Act; or any other quality measures that CMS determines to have an 
evidence-based focus and to be reliable and valid.
    It has come to our attention that some have interpreted Sec.  
414.1415(b)(2) to mean that measures on the MIPS final list or 
submitted in response to the MIPS Call for Quality Measures necessarily 
are MIPS-comparable quality measures, even if they are not evidence-
based, reliable, and valid. We did not intend to imply that any measure 
that was merely submitted in response to the annual call for quality 
measures or developed using Quality Payment Program funding would 
automatically qualify as MIPS-comparable even if the measure was never 
endorsed by a consensus-based entity, adopted under MIPS, or otherwise 
determined to be evidence-based, reliable, and valid. While we believe 
such measures may be evidence-based, reliable, and valid, we did not 
intend to consider them so for purposes of Sec.  414.1415(b)(2) without 
independent verification by a consensus-based entity, or based on our 
own assessment and determination, that they are evidence-based, 
reliable, and valid. We further believe the same principle applies to 
Qualified Clinical Data Registry (QCDR) measures. If QCDR measures are 
endorsed by a consensus-based entity they are presumptively considered 
MIPS-comparable quality measures for purposes of Sec.  414.1415(b)(2); 
otherwise we would have needed independent verification, or to make our 
own assessment and determination, that the measures are evidence-based, 
reliable, and valid before considering them to be MIPS-comparable 
quality measures (see 81 FR 77415 through 77417).
    Because of the potential ambiguity in the existing definition and 
out of an abundance of caution in order to avoid any adverse impact on 
APM entities, eligible clinicians, or other stakeholders, we have used 
the more permissive interpretation of the regulation text, wherein 
measures developed under section 1848(s) of the Act and submitted in 
response to the MIPS Call for Quality Measures will meet the quality 
criterion in implementing the program thus far, and intend to use this 
interpretation for the 2019 QP Performance Period until our new 
proposal described below is

[[Page 35991]]

effective on January 1, 2020. Recognizing that APMs and other payer 
payment arrangements that we might consider for Advanced APM and Other 
Payer Advanced APM determinations are well into development for 2019, 
we are proposing to amend our regulation at Sec.  414.1415(b)(2) to be 
effective as of January 1, 2020. Specifically, we propose that at least 
one of the quality measures upon which an Advanced APM bases the 
payment in paragraph (b)(1) of this section must be finalized on the 
MIPS final list of measures, as described in Sec.  414.1330; be 
endorsed by a consensus-based entity; or otherwise determined by CMS to 
be evidenced-based, reliable, and valid.
    That is, for QP Performance Period 2020 and all future QP 
Performance Periods, we will treat any measure that is either included 
in the MIPS final list of measures or has been endorsed by a consensus-
based entity as presumptively evidence-based, reliable, and valid. All 
other measures would need to be independently determined by CMS to be 
evidence-based, reliable, and valid, in order to be considered MIPS-
comparable quality measures.
    We believe this revised regulation would better articulate our 
interpretation of the statute and reflect the MIPS-comparable quality 
measure standards that are currently met by all Advanced APMs in 
operation, and that we anticipate would be met by those under 
development. Additionally, this clarification is intended to align with 
our parallel proposal for the Other Payer Advanced APM criteria, and 
maintain consistency between the Advanced APM and Other Payer Advanced 
APM criteria. We believe this proposal will better align our 
regulations and inform stakeholders, particularly eligible clinicians 
or APM Entities who may be participating in both Advanced APMs and 
Other Payer Advanced APMs in CY 2019, of the applicable quality measure 
requirements, while also helping non-Medicare payers to continue 
developing payment arrangements that meet the quality measure criterion 
to be an Other Payer Advanced APM as discussed at 82 FR 53847.
    We seek comment on this proposal.
(c) Outcome Measures: Evidence-Based, Reliable, and Valid
    In Sec.  414.1415(b)(3), we generally require that the measures 
upon which an Advanced APM bases payment must include at least one 
outcome measure, but specify that this requirement does not apply if 
CMS determines that there are no available or applicable outcome 
measures in the MIPS quality measure lists for the Advanced APM's first 
QP Performance Period. We note that the current regulation does not 
require that the outcome measure be evidence-based, reliable, and 
valid. While it was our general expectation when crafting the CY 2017 
Quality Payment Program final rule that outcome measures would meet 
this standard, we did not explicitly include this requirement.
    We are proposing to modify Sec.  414.1415(b)(3) to explicitly 
require that an outcome measure must be evidence-based, reliable, and 
valid (unless, as specified in the current regulation, there is no 
available or applicable outcome measure). This proposal would have an 
effective date of January 1, 2020, and would specifically require that 
at least one outcome measure for which measure results are included as 
a factor when determining payment to participants under the terms of 
the APM for purposes of paragraph (b)(1) must also be a MIPS-comparable 
quality measure. This is intended to align with our parallel proposal 
for the Other Payer Advanced APM criteria. We believe this proposal 
will better align our regulations and inform stakeholders, particularly 
eligible clinicians or APM Entities who may be participating in both 
Advanced APMs and Other Payer Advanced APMs in CY 2019, of the 
originally intended applicable outcomes measure requirements for APMs 
to be deemed Advanced APMs and for payment arrangements to be deemed 
Other Payer Advanced APMs, while also helping non-Medicare payers to 
continue developing payment arrangements that meet the outcomes measure 
requirement to be an Other Payer Advanced APM.
    As such, we propose to modify Sec.  414.1415(b)(3) (as similarly 
proposed in the General Quality Measures: Evidence-Based, Reliable, and 
Valid section III.H.4.d.(3)(b) of this proposed rule), so that at least 
one outcome measure used for purposes of Sec.  414.1415(b)(1) must also 
be:
     Finalized on the MIPS final list of measures, as described 
in Sec.  414.1330;
     Endorsed by a consensus-based entity; or
     Determined by CMS to be evidence-based, reliable, and 
valid.
    As for the proposed requirement for an evidence-based, reliable, 
and valid quality measure, as we discuss in section III.H.4.d.(3)(b) of 
this proposed rule, we propose to treat any measure that is either 
included in the MIPS final list of measures or has been endorsed by a 
consensus-based entity as presumptively evidence-based, reliable, and 
valid. All other measures would need to be determined by CMS to be 
evidence-based, reliable, and valid.
    We believe this modification to our regulation would increase the 
likelihood that the inclusion of quality measures in Advanced APMs will 
lead to improvements in the quality of care and resulting patient 
outcomes. Because an Advanced APM is required to base payment on an 
outcome measure, (unless an applicable outcome measure is not 
available), participants in Advanced APMs may have powerful financial 
incentives to modify their behaviors to improve their performance on 
this measure. Outcome measures that are not evidence-based, reliable, 
and valid may encourage adverse patient selection, or create other 
unintended or perverse incentives for model participants. As such, we 
believe it is important that the outcome measures on which results are 
included as a factor when determining payment under the APM must be 
evidence-based, reliable, and valid. We note that these proposed 
changes would not change the status of any APMs in our current 
portfolio of Advanced APMs.
    We seek comment on this proposal.
(4) Bearing Financial Risk for Monetary Losses
(a) Overview
    In the CY 2017 Quality Payment Program final rule, we finalized the 
amount of the generally applicable revenue-based nominal amount 
standard at 8 percent for the first two QP Performance Periods only, 
and we sought comment on what the revenue-based nominal amount standard 
should be for the third and subsequent QP Performance Periods. 
Specifically, we sought comment on: (1) Setting the revenue-based 
standard for 2019 and later at up to 15 percent of revenue; or (2) 
setting the revenue-based standard at 10 percent so long as risk is at 
least equal to 1.5 percent of expected expenditures for which an APM 
Entity is responsible under an APM (81 FR 77427).
    In the CY 2018 Quality Payment Program final rule, we finalized our 
proposal to maintain the generally applicable revenue-based nominal 
amount standard at 8 percent for the 2019 and 2020 QP Performance 
Periods at Sec.  414.1415(c)(3)(i)(A). We also specified that the 
standard is based on the average estimated total Medicare Parts A and B 
revenue of all providers and suppliers in participating APM Entities. 
We stated that we would address the nominal amount standard for QP 
Performance Periods after 2020 in future rulemaking (82 FR 53838).

[[Page 35992]]

(b) Generally Applicable Nominal Amount Standard
    We propose to amend our regulation at Sec.  414.1415(c)(3)(i)(A) to 
maintain the generally applicable revenue-based nominal amount standard 
at 8 percent of the average estimated total Medicare Parts A and B 
revenue of all providers and suppliers in participating APM Entities 
for QP Performance Periods 2021 through 2024.
    We continue to believe that 8 percent of Medicare Parts A and B 
revenues of all providers and suppliers in participating APM Entities 
generally represents an appropriate standard for more than a nominal 
amount of financial risk at this time. We also believe that maintaining 
a consistent standard for several more years will help APM Entities to 
plan for multi-year Advanced APM participation. We further believe that 
maintaining a consistent standard will allow us to evaluate how APM 
Entities succeed within these parameters over the applicable timeframe.
    We seek comment on the proposal to maintain the 8 percent nominal 
amount standard for QP Performance Periods through 2024.
    We also seek comment on whether, as APM entities and participating 
eligible clinicians grow more comfortable with assuming risk, we should 
consider increasing the nominal amount standard. Specifically, we 
request comments on whether we should consider raising the revenue-
based nominal amount standard to 10 percent, and the expenditure-based 
nominal amount standard to 4 percent starting for QP Performance 
Periods in 2025 and later.
(5) Summary of Proposals
    In this section, we are proposing the following policies:
     Use of CEHRT:
    ++ We are proposing to revise our regulation at Sec.  
414.1415(a)(i) to specify that an Advanced APM must require at least 75 
percent of eligible clinicians in each APM Entity use CEHRT as defined 
at Sec.  414.1305 to document and communicate clinical care with 
patients and other health care professionals.
     MIPS-Comparable Quality Measures
    ++ We are proposing to revise our regulation to clarify at Sec.  
414.1415(b)(2), effective January 1, 2020, that at least one of the 
quality measures upon which an Advanced APM bases the payment in 
paragraph (b)(1) of this section must either be finalized on the MIPS 
final list of measures, as described in Sec.  414.1330; endorsed by a 
consensus-based entity; or determined by CMS to be evidenced-based, 
reliable, and valid.
    ++ We are also proposing to revise our regulation at Sec.  
414.1415(b)(3), effective January 1, 2020, to provide that at least one 
outcome measure, for which measure results are included as a factor 
when determining payment to participants under the terms of the APM 
must either be finalized on the MIPS final list of measures as 
described in Sec.  414.1330, endorsed by a consensus-based entity; or 
determined by CMS to be evidence-based, reliable, and valid.
     Bearing Financial Risk for Monetary Losses: We propose to 
amend our regulation at Sec.  414.1415(c)(3)(i)(A) to maintain the 
generally applicable revenue-based nominal amount standard at 8 percent 
of the average estimated total Medicare Parts A and B revenue of all 
providers and suppliers in participating APM Entities for QP 
Performance Periods 2021 through 2024.
e. Qualifying APM Participant (QP) and Partial QP Determinations
(1) Overview
    We finalized policies relating to QP and Partial QP determinations 
in the CY 2017 Quality Payment Program final rule (81 FR 77433 through 
77450).
(2) QP Performance Period
    In the CY 2017 Quality Payment Program final rule, we finalized for 
the timing of QP determinations that a QP Performance Period runs from 
January 1 through August 31 of the calendar year that is 2 years prior 
to the payment year (81 FR 77446-77447). During that QP Performance 
Period, we will make QP determinations at three separate snapshot dates 
(March 31, June 30, and August 31), each of which would be a final 
determination for the eligible clinicians who are determined to be QPs. 
The QP Performance Period and the three separate QP determinations 
apply similarly for both the group of eligible clinicians on a 
Participation List and the individual eligible clinicians on an 
Affiliated Practitioner List.
    We also finalized that for each of the three QP determinations, we 
will allow for claims run-out for 3 months, or 90 days, before 
calculating the Threshold Scores so that QP determinations will be 
completed approximately 4 months after each snapshot date. As a result, 
the last of these three QP determinations is complete on or around 
January 1 of the subsequent calendar year, which is the year 
immediately prior to the MIPS payment year. For most MIPS data 
submission types, January 1 of the subsequent calendar year is also the 
beginning of the MIPS data submission period. This way, eligible 
clinicians know of their QP status prior to or near the beginning of 
the MIPS data submission period and know whether they should report any 
performance period data to MIPS for the applicable MIPS payment year.
    Upon further consideration and based on our experience implementing 
the program to date, we believe providing eligible clinicians 
notification of their QP status more quickly after each of the three QP 
determination snapshot dates, and prior to the beginning of the MIPS 
data submission period after the last determination, will potentially 
reduce burden for eligible clinicians and APM Entities while improving 
their overall experience participating in the program.
    Therefore, we propose that for each of the three QP determination 
dates, we will allow for claims run-out for 60 days (approximately 2 
months), before calculating the Threshold Scores so that the three QP 
determinations will be completed approximately 3 months after the end 
of that determination time period. We note that this proposal does not 
affect the QP Performance Period per se, but rather the date by which 
claims for services furnished during the QP Performance Period would 
need to be processed in order for those services to be included in 
calculating the Threshold Scores. To the extent that claims are used 
for calculating the Threshold Scores, such claims would have to be 
processed by no later than 60 days after each of the three QP 
determination dates, in order for information on the claims to be 
included in our calculations. Based on our analysis of Medicare Part B 
claims for 2014, we found that there is only a 0.5 percent difference 
in claims processing completeness when using 60 days rather than 90 
days.
    We seek comment on this proposal.
(3) Partial QP Election To Report to MIPS
(a) Overview
    Section 1848(q)(1)(C)(ii)(II) of the Act excludes from the 
definition of MIPS eligible clinician an eligible clinician who is a 
Partial QP for a year and who does not report on applicable measures 
and activities as required under MIPS for the year. However, under 
section 1848(q)(1)(C)(vii) of the Act, an eligible clinician who is a 
Partial QP for a year and reports on applicable measures and activities 
as required under the MIPS is considered to be a MIPS eligible 
clinician for the year.
    In the CY 2017 Quality Payment Program final rule, we finalized 
that following a determination that eligible

[[Page 35993]]

clinicians in an APM Entity group in an Advanced APM are Partial QPs 
for a year, the APM Entity will make an election whether to report on 
applicable measures and activities as required under MIPS. If the APM 
Entity elects to report to MIPS, all eligible clinicians in the APM 
Entity would be subject to the MIPS reporting requirements and payment 
adjustments for the relevant year. If the APM Entity elects not to 
report, all eligible clinicians in the APM Entity group will be 
excluded from the MIPS reporting requirements and payment adjustments 
for the relevant year (81 FR 77449).
    We also finalized that in cases where the Partial QP determination 
is made at the individual eligible clinician level, if the individual 
eligible clinician is determined to be a Partial QP, the eligible 
clinician will make the election whether to report on applicable 
measures and activities as required under MIPS and, as a result, be 
subject to the MIPS reporting requirements and payment adjustment (81 
FR 77449). If the individual eligible clinician elects to report to 
MIPS, he or she would be subject to the MIPS reporting requirements and 
payment adjustments for the relevant year. If the individual eligible 
elects not to report to MIPS, he or she will be excluded from the MIPS 
reporting requirements and payment adjustments for the relevant year. 
We note that QP determinations are made at the individual eligible 
clinician level when the clinician is identified as participating in an 
Advanced APM on an Affiliated Practitioner List rather than a 
Participation List, or when an eligible clinician is in more than one 
APM Entity group in one or more Advanced APMs, and does not achieve QP 
status as part of any single APM Entity group (see Sec.  414.1425(b)(2) 
and (c)(4) our regulations).
    We also clarified how we consider the absence of an explicit 
election to report to MIPS or to be excluded from MIPS. We finalized 
that for situations in which the APM Entity is responsible for making 
the decision on behalf of all eligible clinicians in the APM Entity 
group, the group of Partial QPs will not be considered MIPS eligible 
clinicians unless the APM Entity opts the group into MIPS 
participation, so that no actions other than the APM Entity's election 
for the group to participate in MIPS would result in MIPS participation 
(81 FR 77449).
    For eligible clinicians who are determined to be Partial QPs 
individually, we finalized that we will use the eligible clinician's 
actual MIPS reporting activity to determine whether to exclude the 
Partial QP from MIPS in the absence of an explicit election. Therefore, 
if an eligible clinician who is individually determined to be a Partial 
QP submits information to MIPS (not including information automatically 
populated or calculated by CMS on the Partial QP's behalf), we will 
consider the Partial QP to have reported, and thus to be participating 
in MIPS. Likewise, if such an individual does not take any action to 
submit information to MIPS, we will consider the Partial QP to have 
elected to be excluded from MIPS (81 FR 77449).
(b) Alignment of Partial QP Election Policies
    Upon further consideration and based on our experience implementing 
the program to date, we believe there is value in aligning our Partial 
QP election policies across all eligible clinicians, whether they 
achieved Partial QP status as a part of an APM Entity or as an 
individual. We believe this approach will allow for greater simplicity 
and clarity for stakeholders.
    Therefore, we propose that when an eligible clinician is determined 
to be a Partial QP for a year at the individual eligible clinician 
level, the individual eligible clinician will make an election whether 
to report to MIPS. If the eligible clinician elects to report to MIPS, 
they will be subject to MIPS reporting requirements and payment 
adjustments. If the eligible clinician elects to not report to MIPS, 
they will not be subject to the MIPS reporting requirements and payment 
adjustment. If the eligible clinician does not make any election, they 
will not be subject to the MIPS reporting requirements and payment 
adjustment.
    We believe that this default minimizes the possibility of 
unexpected participation in MIPS. Currently, eligible clinicians who 
are determined to be Partial QPs individually could inadvertently be 
subject to the MIPS reporting requirements and payment adjustment based 
on reporting behavior that is not fully within their control. We also 
believe this approach will minimize the risk that an individual 
eligible clinician, particularly one whose NPI is associated with 
multiple billing TINs, inadvertently will be subject to MIPS when that 
was not that clinician's preference or expectation. We believe it is 
important that we act in accordance with the preference of an eligible 
clinician who is individually determined to be a Partial QP with 
regards to whether they wish to be excluded from MIPS based on the QP 
status they were able to achieve, regardless of the MIPS reporting 
election decisions of other TINs with which that Partial QP's NPI is 
associated.
    Furthermore, this proposal creates alignment in the implementation 
of our Partial QP election policy for eligible clinicians who are 
determined to be Partial QPs individually and for eligible clinicians 
who are determined to be Partial QPs at the APM Entity level. 
Currently, for eligible clinicians who are determined to be Partial QPs 
at the APM Entity level, that group of Partial QPs will not be 
considered MIPS eligible clinicians in the absence of an explicit 
election to report to MIPS or to be excluded from MIPS by their APM 
Entity (81 FR 77449). This proposal would establish the same default in 
the absence of an explicit election to report to MIPS or to be excluded 
from MIPS for eligible clinicians who are determined to be Partial QPs 
individually, so that no actions other than the individual Partial QP's 
affirmative election to participate in MIPS would result in MIPS 
participation.
    We note that this policy change would only affect situations where 
the Partial QP makes no election to either report to MIPS or to be 
excluded from the MIPS reporting requirements and payment adjustment. 
Under our proposed policy, all Partial QPs retain the full right to 
affirmatively decide through the election process whether or not to be 
subject to the MIPS reporting requirements and payment adjustment; 
whereas, if the Partial QP does not make any election, they will not be 
subject to the MIPS reporting requirements and payment adjustment.
    We seek comment on this proposal.
(4) Summary of Proposals
    In this section, we are proposing the following policies:
    We propose that for each of the three QP determinations, we will 
allow for claims run-out for 60 days (approximately 2 months), before 
calculating the Threshold Scores so that the three QP determinations 
will be completed approximately 3 months after the end of that 
determination time period.
    We also propose that when an eligible clinician is determined to be 
a Partial QP for a year at the individual eligible clinician level, the 
individual eligible clinician will make an election whether to report 
to MIPS. If the eligible clinician elects to report to MIPS, they will 
be subject to the MIPS reporting requirements and payment adjustment. 
If the eligible clinician elects not to report, they will be excluded 
from the MIPS reporting requirements and payment adjustment. In the 
absence of an explicit election to report to MIPS,

[[Page 35994]]

the eligible clinician will be excluded from the MIPS reporting 
requirements and payment adjustment. This means that no actions other 
than the eligible clinician's affirmative election to participate in 
MIPS would result in that eligible clinician becoming subject to the 
MIPS reporting requirements and payment adjustment.
g. All-Payer Combination Option
(1) Overview
    Section 1833(z)(2)(B)(ii) of the Act requires that beginning in 
payment year 2021, in addition to the Medicare Option, eligible 
clinicians may become QPs through the Combination All-Payer and 
Medicare Payment Threshold Option, which we refer to as the All-Payer 
Combination Option. In the CY 2017 Quality Payment Program final rule, 
we finalized our overall approach to the All-Payer Combination Option 
(81 FR 77459). The Medicare Option focuses on participation in Advanced 
APMs, and we make QP determinations under this option based on Medicare 
Part B covered professional services attributable to services furnished 
through an APM Entity. The All-Payer Combination Option does not 
replace or supersede the Medicare Option; instead, it will allow 
eligible clinicians to become QPs by meeting the QP thresholds through 
a pair of calculations that assess a combination of both Medicare Part 
B covered professional services furnished through Advanced APMs and 
services furnished through Other Payer Advanced APMs. We finalized that 
beginning in payment year 2021, we will conduct QP determinations 
sequentially so that the Medicare Option is applied before the All-
Payer Combination Option (81 FR 77438). The All-Payer Combination 
Option encourages eligible clinicians to participate in payment 
arrangements with payers other than Medicare that have payment designs 
that satisfy the Other Payer Advanced APM criteria. It also encourages 
sustained participation in Advanced APMs across multiple payers.
    We finalized that the QP determinations under the All-Payer 
Combination Option are based on payment amounts or patient counts as 
illustrated in Tables 36 and 37, and Figures 1 and 2 of the CY 2017 
Quality Payment Program final rule (81 FR 77460 through 77461). We also 
finalized that, in making QP determinations with respect to an eligible 
clinician, we will use the Threshold Score that is most advantageous to 
the eligible clinician toward achieving QP status, or if QP status is 
not achieved, Partial QP status, for the year (81 FR 77475).

                                          Table 57--QP Payment Amount Thresholds--All-Payer Combination Option
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                          2023 and later
              Payment year                             2019                            2020                  2021 (%)        2022 (%)           (%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
QP Payment Amount Threshold:
    Medicare Minimum....................  N/A...........................  N/A...........................              25              25              25
    Total...............................  ..............................  ..............................              50              50              75
Partial QP Payment Amount Threshold:
    Medicare Minimum....................  N/A...........................  N/A...........................              20              20              20
    Total...............................  ..............................  ..............................              40              40              50
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                           Table 58--QP Patient Count Thresholds--All-Payer Combination Option
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                          2023 and later
              Payment year                             2019                            2020                  2021 (%)        2022 (%)           (%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
QP Patient Count Threshold:
    Medicare Minimum....................  N/A...........................  N/A...........................              20              20              20
    Total...............................  ..............................  ..............................              35              35              50
Partial QP Patient Count Threshold:
    Medicare Minimum....................  N/A...........................  N/A...........................              10              10              10
    Total...............................  ..............................  ..............................              25              25              35
--------------------------------------------------------------------------------------------------------------------------------------------------------

BILLING CODE 4120-01-P

[[Page 35995]]

[GRAPHIC] [TIFF OMITTED] TP27JY18.045

BILLING CODE 4120-01-C
    Unlike the Medicare Option, where we have access to all of the 
information necessary to determine whether an APM meets the criteria to 
be an Advanced APM, we cannot determine whether an other payer 
arrangement meets the criteria to be an Other Payer Advanced APM 
without receiving information about the payment arrangement from an 
external source. Similarly, we do not have the necessary payment amount 
and patient count information to determine under the All-Payer 
Combination Option whether an eligible clinician meets the payment 
amount or patient count threshold to be a QP without receiving certain 
information from an external source.
    In the CY 2018 Quality Payment Program final rule, we established 
additional policies to implement the All-Payer Combination Option and 
finalized certain modifications to our previously finalized policies 
(82 FR 53844 through 53890). A detailed summary of those policies can 
be found at 82 FR 53874 through 53876 and 53890 through 53891. In 
relevant part, we finalized the following:
Payer Initiated Process
     We finalized at Sec.  414.1445(a) and (b)(1) that certain 
other payers, including payers with payment arrangements authorized 
under Title XIX (the Medicaid statute), Medicare Health Plan payment 
arrangements, and payers with payment arrangements aligned with a CMS 
Multi-Payer Model, can request that we determine whether their other 
payer arrangements are Other Payer Advanced APMs starting prior to the 
2019 QP Performance Period and each year thereafter. We finalized that 
remaining other payers, including

[[Page 35996]]

commercial and other private payers, could request that we determine 
whether other payer arrangements are Other Payer Advanced APMs starting 
in 2019 prior to the 2020 QP Performance Period, and annually each year 
thereafter. We generally refer to this process as the Payer Initiated 
Other Payer Advanced APM Determination Process (Payer Initiated 
Process), and we finalized that the Payer Initiated Process would 
generally involve the same steps for each payer type for each QP 
Performance Period. If a payer uses the same other payer arrangement in 
other commercial lines of business, we finalized our proposal to allow 
the payer to concurrently request that we determine whether those other 
payer arrangements are Other Payer Advanced APMs as well. This policy 
is relevant only to the initial year of Payer Initiated Other Payer 
Advanced APM determinations for which these submissions can be made 
only by payers with arrangements under Title XIX, Medicare Health 
Plans, or arrangements aligned with CMS multi-payer models.
Eligible Clinician Initiated Process
     We finalized at Sec.  414.1445(a) and (b)(2) that, through 
the Eligible Clinician Initiated Process, APM Entities and eligible 
clinicians participating in other payer arrangements would have an 
opportunity to request that we determine for the year whether those 
other payer arrangements are Other Payer Advanced APMs. The Eligible 
Clinician Initiated Process can be used to submit requests for 
determinations before the beginning of a QP Performance Period for 
other payer arrangements authorized under Title XIX. The Eligible 
Clinician Initiated Process is available for the 2019 QP Performance 
Period and each year thereafter.
Submission of Information for Other Payer Advanced APM Determinations
     We finalized that, for each other payer arrangement for 
which a payer requests us to make an Other Payer Advanced APM 
determination, the payer must complete and submit the Payer Initiated 
Submission Form by the relevant Submission Deadline.
     We finalized that, for each other payer arrangement for 
which an APM Entity or eligible clinician requests us to make an Other 
Payer Advanced APM determination, the APM Entity or eligible clinician 
must complete and submit the Eligible Clinician Initiated Submission 
Form by the relevant Submission Deadline.
     We removed the requirement, previously established at 
Sec.  414.1445(b)(3), that payers must attest to the accuracy of 
information submitted by eligible clinicians, and we also removed the 
related attestation requirement at Sec.  414.1460(c). Instead, we 
finalized an additional requirement at Sec.  414.1445(d) that an APM 
Entity or eligible clinician that submits information under Sec.  
414.1445(c) must certify that, to the best of its knowledge, the 
information it submits to us is true, accurate, and complete.
QP Determinations Under the All-Payer Combination Option
     We finalized at Sec.  414.1440(e) that eligible clinicians 
may request that we make QP determinations at the individual eligible 
clinician level and that APM Entities may request that we make QP 
determinations at the APM Entity level.
     We finalized at Sec.  414.1440(d)(1) that we will make QP 
determinations under the All-Payer Combination Option based on eligible 
clinicians' participation in Advanced APMs and Other Payer Advanced 
APMs for three time periods of the QP Performance Period: January 1 
through March 31; January 1 through June 30; and January 1 through 
August 31. We finalized that we will use patient or payment data for 
the same time periods to calculate both the Medicare and the other 
payer portion of the Threshold Score calculation under the All-Payer 
Cominbation Option.
     We finalized at Sec.  414.1440(e)(4) that, to request a QP 
determination under the All-Payer Combination Option, APM Entities or 
eligible clinicians must submit all of the payment amount and patient 
count information sufficient for us to make QP determinations by 
December 1 of the calendar year that is 2 years to prior to the payment 
year, which we refer to as the QP Determination Submission Deadline.
    In this section of the proposed rule, we address policies within 
the following topics: Other Payer Advanced APM Criteria; Other Payer 
Advanced APM determinations; and Calculation of the All-Payer 
Combination Option Threshold Scores and QP Determinations.
(2) Other Payer Advanced APM Criteria
(a) Overview
    In general, our goal is to align the Advanced APM criteria under 
the Medicare Option and the Other Payer Advanced APM criteria under the 
All-Payer Combination Option as permitted by statute and as feasible 
and appropriate. We believe this alignment would help simplify the 
Quality Payment Program and encourage participation in Other Payer 
Advanced APMs (82 FR 53847).
(b) Investment Payments
    Some stakeholders have requested that we take into account 
``business risk'' costs such as IT, personnel, and other administrative 
costs associated with APM Entities' participation in Other Payer 
Advanced APMs when implementing the financial risk standard. We are not 
proposing to modify our financial risk standard in response to this 
suggestion, and note that financial risk in the context of Other Payer 
Advanced APMs is defined both in the Act (at section 
1833(z)(2)(B)(iii)(II)(cc) for payment years 2021 and 2022, and section 
1833(z)(3)(B)(iii)(II)(cc) for subsequent years) and our regulations at 
Sec.  414.1420(d) so as to require that APM Entities in the payment 
arrangement must assume financial risk when actual expenditures exceed 
expected expenditures. However, we note that a payment arrangement with 
an other payer, like some APMs, can be structured so that the APM 
provides an investment payment to the participating APM Entities to 
assist with the practice transformation that may be required for 
participation in the payment arrangement. This investment payment could 
be structured in various ways; for example, it could be structured 
similarly to the Medicare ACO Investment model under, which expected 
shared savings payment were pre-paid to encourage new ACOs to form in 
rural and underserved areas and to assist existing ACOs in meeting 
certain criteria; or it could be structured so that the payment is made 
specifically to encourage participating APM Entities to continue to 
make staffing, infrastructure, and operations investments as a means of 
practice transformation; or it could have a different structure 
entirely.
(c) Use of CEHRT
(i) Overview
    In the CY 2017 Quality Payment Program final rule, we finalized 
that to be an Other Payer Advanced APM, the other payer arrangement 
must require at least 50 percent of participating eligible clinicians 
in each APM Entity, or each hospital if hospitals are the APM Entities, 
to use CEHRT to document and communicate clinical care (81 FR 77465). 
This CEHRT use criterion directly paralleled the criterion established 
for Advanced APMs in Sec.  414.1415(a)(1)(i).

[[Page 35997]]

    In the CY 2018 Quality Payment Program final rule, we finalized 
that we would presume that an other payer arrangement meets the 50 
percent CEHRT use criterion if we receive information and documentation 
from the eligible clinician through the Eligible Clinician Initiated 
Process showing that the other payer arrangement requires the 
requesting eligible clinician to use CEHRT to document and communicate 
clinical care (see Sec.  414.1445(c)(2)). We sought comment on whether 
we should consider revising the 50 percent CEHRT use requirement in 
future years, and if so what standard we should use in its place (82 FR 
53874).
(ii) Increasing the CEHRT Use Criterion for Other Payer Advanced APMs
    We are proposing to change the current CEHRT use criterion for 
Other Payer Advanced APMs so that in order to qualify as an Other Payer 
Advanced APM as of January 1, 2020, the other payer arrangement must 
require at least 75 percent of participating eligible clinicians in 
each APM Entity to use CEHRT.
    According to data collected by ONC, since the CY 2017 Quality 
Payment Program final rule was published, EHR adoption has been 
widespread, and we want to encourage continued adoption. Additionally, 
in response to the CY 2017 Quality Payment Program proposed rule 
stakeholders encouraged us to raise the CEHRT threshold to 75 percent 
in previous comment solicitations (see 81 FR 77411). We believe that 
this proposed change aligns with our proposed change in the Advanced 
APM section, wherein we also propose raising the CEHRT use criterion to 
75 percent. We believe that this proposed change aligns with the 
increased adoption of CEHRT among providers and suppliers that is 
already happening, and would encourage further CEHRT adoption. Further, 
we believe the January 1, 2020, adoption date would give stakeholders 
sufficient time to make the necessary changes for the adoption of this 
requirement; specifically, this will allow other payers additional time 
to address the proposed increase to the CEHRT use criterion.
    We seek comment on this proposal.
(iii) Evidence of CEHRT Use
    In the CY 2017 Quality Payment Program final rule, we adopted a 
CEHRT use criterion for Other Payer Advanced APMs that directly 
paralleled the CEHRT use criterion for Advanced APMs wherein Other 
Payer Advanced APMs must require at least 50 percent of eligible 
clinicians in each participating APM Entity, or each hospital if 
hospitals are the APM Entities, to use CEHRT to document and 
communicate clinical care.
    We have since heard from payers and other stakeholders that CEHRT 
is often used under other payer arrangements even if it is not 
expressly required under the payment arrangement. Because CEHRT use is 
increasingly common among eligible clinicians, payers may not believe 
it is necessary to specifically require the use of CEHRT under the 
terms of an Other Payer payment arrangement.
    We also note that the statutory CEHRT use requirement for Other 
Payer Advanced APMs differs from the comparable standard for Advanced 
APMs. The statutory CEHRT use criterion for Advanced APMs under section 
1833(z)(3)(D)(i)(I) of the Act specifies that the APM must require 
participants in such model to use CEHRT. This differs from section 
1833(z)(2)(B)(iii)(II)(bb) of the Act (for payment years 2021 and 2022) 
and section 1833(z)(2)(C)(iii)(II)(bb) of the Act (for payment years 
beginning in 2023), which specify that Other Payer Advanced APMs are 
payment arrangements in which ``CEHRT is used.''
    Given this, we believe our current policy may needlessly exclude 
certain existing payment arrangements that could meet the statutory 
requirements for Other Payer Advanced APMs--including some where the 
majority of eligible clinicians use CEHRT, even if they are not 
explicitly required to do so under the terms of their payment 
arrangements. Accordingly, we are proposing to modify our current 
policy to offer additional flexibility that we believe would match more 
closely with both the statute and current practices among other payers.
    We are proposing that a payer or eligible clinician must provide 
documentation to CMS that CEHRT is used to document and communicate 
clinical care under the payment arrangement by at least 50 percent of 
eligible clinicians in 2019, and 75 percent of the eligible clinicians 
in 2020 and beyond, whether or not such CEHRT use is explicitly 
required under the terms of the payment arrangement. We are 
specifically proposing to modify the regulation at Sec.  414.1420(b) to 
specify that to be an Other Payer Advanced APM, CEHRT must be used by 
at least 50 percent of eligible clinicians participating in the 
arrangement in 2019 (or, beginning in 2020, 75 percent) of such 
eligible clinicians).
    While a payer that requests an Other Payer Advanced APM 
determination for a payment arrangement could continue to meet the 
proposed CEHRT use requirement by demonstrating that CEHRT use is 
required of at least 50 percent of eligible clinicians in 2019, (or, 
beginning in 2020, of at least 75 percent of eligible clinicians), 
under the terms of the payment arrangement, the payer and eligible 
clinicians also could meet the criterion by documenting CEHRT use among 
participating APM entities. Documentation could come from a variety of 
sources. For example, the level of CEHRT use in a particular State 
Medicaid program could be demonstrated by presenting data from the ONC 
showing the CEHRT adoption rate for all physicians in that state along 
with state data on the percentage of physicians that participate in the 
State Medicaid program. Similarly, commercial payers could document 
that CEHRT adoption rates within their networks meet or exceed the 
relevant CEHRT use percentage for the year. This is not an exhaustive 
list of ways that other payers could document CEHRT use under their 
payment arrangements, but suggests some of the possible ways to do so. 
With regard to submissions from eligible clinicians, similar sources of 
information on CEHRT adoption could be used, such as data from the 
State Medicaid Agency or the local health information exchange. To 
determine whether the CEHRT use criterion is met, we are willing to 
consider data from a payer or eligible clinician. Based on our 
conversations with other payers regarding their payment arrangements, 
including States with regard to their Medicaid payer arrangements, 
Medicare Advantage Organizations with regard to their Medicare 
Advantage arrangements, and commercial payers, we believe this 
modification would offer additional flexibility and potentially match 
more closely with the current commercial payer landscape, as CEHRT is 
likely often used under other payer arrangements even if it is not 
expressly required in the agreement.
    We seek comment on this proposal.
(d) MIPS Comparable Quality Measures
(i) Overview
    In the CY 2017 Quality Payment Program final rule, we explained 
that one of the criteria for a payment arrangement to be an Other Payer 
Advanced APM is that it must apply quality measures comparable to those 
under the MIPS quality performance category (81 FR 77465).
    In the CY 2017 Quality Payment Program proposed rule, we proposed 
that to be an Other Payer Advanced

[[Page 35998]]

APM, a payment arrangement must have quality measures that are 
evidence-based, reliable, and valid; and that at least one measure must 
be an outcome measure if there is an applicable outcome measure on the 
MIPS quality measure list. We generally refer to these measures in the 
remainder of this discussion as ``MIPS-comparable quality measures.'' 
We did not specify that the outcome measure is required to be evidence-
based, reliable, and valid (81 FR 77466). We finalized these policies 
in the CY 2017 Quality Payment Program final rule and codified them in 
the regulation at Sec.  414.1420(c).
(ii) General Quality Measures: Evidence-Based, Reliable, and Valid
    In the CY 2017 Quality Payment Program final rule, we codified at 
Sec.  414.1420(c)(2) that at least one of the quality measures used in 
the payment arrangement with an APM Entity must have an evidence-based 
focus, be reliable, and valid, and meet at least one of the following 
criteria:
     Used in the MIPS quality performance category as described 
in Sec.  414.1330;
     Endorsed by a consensus-based entity;
     Developed under section 1848(s) of the Act;
     Submitted in response to the MIPS Call for Quality 
Measures under section 1848(q)(2)(D)(ii) of the Act; or
     Any other quality measures that CMS determines to have an 
evidence-based focus and to be reliable and valid.
    It has come to our attention that, as with the comparable policy 
for Advanced APMs as discussed at 81 FR 28302, some have read the 
regulation at Sec.  414.1420(c)(2) to mean that measures on the MIPS 
final list or submitted in response to the MIPS Call for Quality 
Measures necessarily are MIPS-comparable quality measures, even if they 
have not been determined to be evidence-based, reliable, and valid. We 
did not intend to imply that any measure that was merely submitted in 
response to the annual call for quality measures or developed using 
Quality Payment Program funding would automatically qualify as MIPS-
comparable even if the measure was never endorsed by a consensus-based 
entity, adopted under MIPS, or otherwise determined to be evidence-
based, reliable, and valid. While we believe such measures may be 
evidence-based, reliable, and valid, we did not intend consider them so 
for purposes of Sec.  414.1420(c)(2) without independent verification 
by a consensus-based entity, or based on our own assessment and 
determination, that they are evidence-based, reliable, and valid. We 
further believe the same principle applies to QCDR measures. If QCDR 
measures are endorsed by a consensus-based entity they are 
presumptively considered MIPS-comparable quality measures for purposes 
of Sec.  414.1420(c)(2); otherwise we would have needed independent 
verification, or to make our own assessment and determination, that the 
measures are evidence-based, reliable, and valid before considering 
them to be MIPS-comparable (see 81 FR 77415 through 77417).
    Because of the potential ambiguity in the existing definition and 
out of an abundance of caution in order to avoid any adverse impact on 
APM entities, eligible clinicians or other stakeholders, we have used 
the more permissive interpretation of the text, wherein measures 
developed under section 1848(s) of the Act and submitted in response to 
the MIPS Call for Quality Measures will meet the quality criterion in 
implementing the program thus far, and intend to use this 
interpretation for the 2019 QP Performance Period. Recognizing that 
APMs and other payer arrangements that we might consider for Advanced 
APM and Other Payer Advanced APM determinations are well into 
development for 2019, we would use this interpretation until our new 
proposal described below is effective on January 1, 2020.
    Therefore, at Sec.  414.1420(c)(2), we are proposing, effective as 
of January 1, 2020, that at least one of the quality measures used in 
the payment arrangement with an APM Entity must meet at least one of 
the following criteria:
     Finalized on the MIPS final list of measures, as described 
in Sec.  414.1330;
     Endorsed by a consensus-based entity; or
     Otherwise determined by CMS to be evidenced-based, 
reliable, and valid.
    That is, for QP Performance Period 2020 and all future QP 
Performance Periods, we would treat any measure that is either included 
in the MIPS final list of measures or has been endorsed by a consensus-
based entity as presumptively evidence-based, reliable, and valid. All 
other measures would need to be independently determined by CMS to be 
evidence-based, reliable, and valid, in order to be considered MIPS-
comparable quality measures.
    We believe this revised regulation would better articulate our 
interpretation of the statute and reflect the MIPS-comparable quality 
measure standards that are currently met by all Advanced APMs in 
operation and that we anticipate would be met by those under 
development. Additionally, this clarification is intended to align with 
our parallel proposal for the Advanced APM criteria, and maintain 
consistency between the Advanced APM and Other Payer Advanced APM 
criteria. We believe this clarification will better align our 
regulations and inform stakeholders, particularly eligible clinicians 
or APM Entities who may be participating in both Advanced APMs and 
Other Payer Advanced APMs in CY 2019, of the applicable quality measure 
requirements, while also helping non-Medicare payers to continue 
developing payment arrangements that meet the quality measure criterion 
to be an Other Payer Advanced APM as discussed at 82 FR 53847.
(iii) Outcome Measures: Evidence-Based, Reliable, and Valid
    In Sec.  414.1420(c)(3), we generally require that, to be an Other 
Payer Advanced APM, the payment arrangement must use an outcome measure 
if there is an applicable outcome measure on the MIPS quality measure 
list. We note that the current regulation does not require that the 
outcome measure be evidence-based, reliable, and valid.
    We are proposing to revise Sec.  414.1420(c)(3), to explicitly 
require that, unless there is no applicable outcome measure on the MIPS 
quality measure list, at least one outcome measure that applies in the 
payment arrangement must be evidence-based, reliable, and valid. This 
proposal would have an effective date of January 1, 2020, and would 
specifically require that an outcome measure must also be MIPS-
comparable. This proposal aligns with the similar proposal for Other 
Payer Advanced APMs discussed at section III.H.4.d.(2)(d)(ii) of this 
proposed rule, so that an outcome measure used in the payment 
arrangement must also be:
     Finalized on the MIPS final list of measures, as described 
in Sec.  414.1330;
     Endorsed by a consensus-based entity; or
     Determined by CMS to be evidence-based, reliable, and 
valid.
    As with the general requirement for an evidence-based, reliable, 
and valid quality measure, as we propose to clarify at section 
III.H.4.d.(2)(d)(ii) of this proposed rule, we would treat any measure 
that is either included in the MIPS final list of measures or has been 
endorsed by a consensus-based entity as presumptively evidence-based, 
reliable, and valid. All other measures would need to be determined by 
CMS to be evidence-based, reliable, and valid.
    We believe this modification to our regulation would increase the 
likelihood

[[Page 35999]]

that Other Payer Advanced APMs use quality measures that will lead to 
improvements in the quality of care and resulting patient outcomes. 
Because an Other Payer Advanced APM is required to use an outcome 
measure unless no one is available, participants in Other Payer 
Advanced APMs may have powerful financial incentives to modify their 
behaviors to improve their performance on this measure. Outcome 
measures that are not evidence-based, reliable, and valid may encourage 
adverse patient selection, or create other unintended and perverse 
incentives for model participants. As such, we believe it is important 
that the outcome measure be evidence-based, reliable, and valid.
    We propose to make this change to our regulation effective January 
1, 2020. This proposed effective date is intended to provide 
stakeholders sufficient notice of, and opportunity to respond to, this 
change in our regulation because the current regulation does not 
explicitly require that an outcomes measures must be evidence-based, 
reliable, and valid and, as a result some Other Payer Advanced APMs 
that were submitted for determination in CY 2018 for the CY 2019 
performance year may not include outcomes measures that are evidence-
based, reliable, and valid.
    We also propose that, for such payment arrangements that are 
determined to be Other Payer Advanced APMs for the 2019 performance 
year and did not include an outcome measure that is evidence-based, 
reliable, and valid, and that are resubmitted for an Other Payer 
Advanced APM determination for the 2020 performance year (whether for a 
single year, or for a multi-year determination as proposed in section 
III.H.4.g.(3)(b) of this proposed rule), we would continue to apply the 
current regulation for purposes of those determinations. Additionally, 
payment arrangements in existence prior to the 2020 performance year 
that are submitted for determination to be Other Payer Advanced APMs 
for the 2020 performance year and later, will be assessed under the 
rules of the current regulation meaning they do not need to include an 
outcome measure that is evidence-based, reliable, and valid to be an 
Other Payer Advanced APM. For all other payment arrangements the 
proposed revised regulation would apply beginning in CY 2020.
    We believe this is necessary because there may be some Other Payer 
Advanced APMs that currently do not include outcomes measures that are 
evidence-based, reliable, and valid because the current regulation does 
not explicitly require it. In order to provide for an even application 
of our current policy and an even transition to the proposed policy, 
and to avoid any adverse impact on APM entities, eligible clinicians or 
other stakeholders, we believe it is appropriate to apply the revision 
to Sec.  414.1420(c)(3) beginning with determinations that occur after 
2020 with respect to those payment arrangements noted above. We also 
note that this exception would apply for only one year for single-year 
determinations, and only through the earlier of the end of the payment 
arrangement or 5 years for determinations under multi-year 
determination process proposed in section III.H.4.g.(3)(b) of this 
proposed rule. For all payment arrangements starting in 2020, or those 
initially submitted for Other Payer Advanced APM determinations for the 
2021 performance year and later, the payment arrangement would need to 
use an outcome measure that is evidence-based, reliable, and valid 
unless there is no applicable outcome measure on the MIPS final quality 
measure list.
    We note that these proposed changes to our regulations would not 
change the status of any payment arrangements that we have determined 
to be Other Payer Advanced APMs for 2019, or for the basis for our 
determinations of Other Payer Advanced APMs in 2019 for 2020.
    We believe a January 1, 2020, effective date would give 
stakeholders sufficient notice of, and opportunity to respond to, this 
change in our regulation.
(e) Financial Risk for Monetary Losses
(i) Overview
    In the CY 2018 Quality Payment Program final rule, we finalized our 
proposal to add a revenue-based nominal amount standard to the 
generally applicable nominal amount standard for Other Payer Advanced 
APMs that is parallel to the generally applicable revenue-based nominal 
amount standard for Advanced APMs. Specifically, we finalized that an 
other payer arrangement would meet the total risk component of the 
proposed nominal risk standard if, under the terms of the other payer 
arrangement, the total amount that an APM Entity potentially owes the 
payer or foregoes is equal to at least: For the 2019 and 2020 QP 
Performance Periods, 8 percent of the total combined revenues from the 
payer of providers and suppliers in participating APM Entities. This 
standard is in addition to the previously finalized expenditure-based 
standard. We explained that a payment arrangement would only need to 
meet one of the two standards. We would use this standard only for 
other payer arrangements where financial risk is expressly defined in 
terms of revenue in the payment arrangement.
(ii) Generally Applicable Nominal Amount Standard
    We propose to amend our regulation at Sec.  414.1420(d)(3)(i) to 
maintain the generally applicable revenue-based nominal amount standard 
at 8 percent of the total combined revenues from the payer of providers 
and suppliers in participating APM Entities for QP Performance Periods 
2019 through 2024.
    We continue to believe that 8 percent the total combined revenues 
from the payer of providers and suppliers in participating APM Entities 
generally represents an appropriate standard for more than a nominal 
amount of financial risk at this time. We further believe that 
maintaining a consistent standard between Advanced APMs and Other Payer 
Advanced APMs will allow us to evaluate how APM Entities succeed within 
these parameters across payers over the applicable timeframe.
    We seek comment on the proposal to maintain the 8 percent nominal 
amount standard for Other Payer Advanced APMs for QP Performance 
Periods through 2024.
(3) Determination of Other Payer Advanced APMs
(a) Overview
    In the CY 2017 Quality Payment Program final rule, we specified 
that an APM Entity or eligible clinician must submit, by a date and in 
a manner determined by us, information necessary to identify whether a 
given payment arrangement satisfies the Other Payer Advanced APM 
criteria (81 FR 77480).
    In the CY 2018 Quality Payment Program final rule, we codified at 
Sec.  414.1445 the Payer Initiated Other Payer Advanced APM 
Determination Process and the Eligible Clinician Initiated Other Payer 
Advanced APM Determination Process pertaining to the determination of 
Other Payer Advanced APMs, as well as specifying the information 
required for Other Payer Advanced APM determinations (82 FR 53814 
through 53873).
(b) Multi-Year Other Payer Advanced APM Determinations
    In the CY 2018 Quality Payment Program final rule, we finalized 
that Other Payer Advanced APM determinations made in response to 
requests submitted either through the Payer Initiated Other Payer 
Advanced APM Determination Process (Payer Initiated Process) or the 
Eligible Clinician Initiated Other Payer Advanced APM Determination 
Process

[[Page 36000]]

(Eligible Clinician Initiated Process) would be in effect for only one 
year at a time. We sought additional comment regarding the current 
duration of payment arrangements and whether creating a multi-year 
determination process would encourage the creation of more multi-year 
payment arrangements as opposed to payment arrangements that are for 
one year only. We also sought comment on what kind of information 
should be submitted annually after the first year to update an Other 
Payer Advanced APM determination (82 FR 53869 through 53870).
    In response to our request for comments, we received several 
comments asking that we allow Other Payer Advanced APM determinations 
to be in effect for more than one year at a time. These commenters 
suggested that requiring annual determinations is burdensome, 
particularly because payment arrangements for other payers are often 
implemented through multi-year contracts.
    After consideration of this feedback, we are proposing to maintain 
the annual submission process with the modifications outlined below for 
both the Payer Initiated Process and the Eligible Clinician Initiated 
Process. We propose that beginning with the 2019 and 2020 submission 
periods for Other Payer Advanced APM determinations for performance 
year 2020, after the first year that a payer, APM Entity, or eligible 
clinician (which we refer to as the ``requester'' in the remainder of 
this discussion) submits a multi-year payment arrangement that we 
determine to be an Other Payer Advanced APM for that year, the 
requester would need to submit information only on any changes to the 
payment arrangement that are relevant to the Other Payer Advanced APM 
criteria for each successive year for the remaining duration of the 
payment arrangement. In the initial submission, the requester would 
certify as usual that the information provided about the payment 
arrangement using the Payer Initiated Process or Eligible Clinician 
Initiated Process, as applicable, is true, accurate, and complete; 
would authorize CMS to verify the information; and would certify that 
they would submit revised information in the event of a material change 
to the payment arrangement. For multi-year payment arrangements, we 
propose to require as part of the submission that the certifying 
official for the requester must agree to review the submission at least 
once annually, to assess whether there have been any changes to the 
information since it was submitted, and to submit updated information 
notifying us of any changes to the payment arrangement that would be 
relevant to the Other Payer Advanced APM criteria and, thus, to our 
determination of the arrangement to be an Other Payer Advanced APM, for 
each successive year of the arrangement. Absent the submission by the 
requester of updated information to reflect changes to the payment 
arrangement, we would continue to apply the original Other Payer 
Advanced APM determination for each successive year through the earlier 
of the end of that multi-year payment arrangement or 5 years.
    We believe this proposal aligns with the multi-year payment 
arrangements between other payers and eligible clinicians. In many 
cases, details of the payment arrangements may not change over the full 
duration of the payment arrangement. In other multi-year arrangements, 
we understand based on public comments that only certain aspects of the 
arrangement may change over the multi-year agreement, while most 
elements of the arrangement remain in place throughout the multi-year 
term of the agreement. However, because we understand that payment 
arrangements between payers and eligible clinicians can be renewed for 
multiple multi-year periods, we propose that the multi-year Other Payer 
Advanced APM determination would remain in effect until the arrangement 
is terminated or expires, but in no event longer than 5 years. Although 
we believe multi-year determinations would appropriately take into 
account multi-year payment arrangements, thereby reducing burden for 
requesters, we also believe that requiring a periodic full submission 
of information about a payment arrangement would be prudent, and that a 
5-year interval is a reasonable time frame to require such a full 
submission using the Payer Initiated Process or Eligible Clinician 
Initiated Process (or other equivalent submission process that is in 
place at that time).
    We believe that our proposal will more accurately reflect the 
manner and timeline on which payers make changes to payment 
arrangements. The current policy requiring payers and eligible 
clinicians to resubmit a comprehensive description of payment 
arrangements each year even after an Other Payer Advanced APM 
determination has been made in the previous year, and when the payment 
arrangements have a term of multiple years and do not change 
significantly from year to year, may be overly burdensome and 
unnecessary as it may require the duplicative resubmission of a 
substantial amount of information each year. Our proposal would 
require, for the shorter of the term of the payment arrangement or five 
years, the submission of information only in the event there are 
changes in the information the requestor has submitted, and only when 
those changes are relevant to the Other Payer Advanced APM criteria and 
our Other Payer Advanced APM determination. We believe that while this 
would allow us to continue to conduct regular reviews of the payment 
arrangements to ensure the criteria for Other Payer Advanced APMs are 
being met, it would greatly reduce the burden on the payers, APM 
Entities, and eligible clinicians that submit requests for Other Payer 
Advanced APM determinations for multi-year payment arrangements.
    Further, we believe this proposal would simplify the Other Payer 
Advanced APM determination process and would likely result in more 
Other Payer Advanced APMs in general, specifically more Other Payer 
Advanced APMs that are identified for multiple successive years. This, 
in turn, would make the Quality Payment Program simpler, as well as 
increase year-to-year consistency, and reliability for clinicians.
    We seek comment on this proposal.
(c) Payer Initiated Other Payer Advanced APM Determination Process 
(Payer Initiated Process)--Remaining Other Payers
    In the CY 2018 Quality Payment Program final rule, we finalized 
that we will allow certain other payers, including payers with payment 
arrangements authorized under Title XIX, Medicare Health Plan payment 
arrangements, and payers with payment arrangements aligned with a CMS 
Multi-Payer Model to use the Payer Initiated Process to request that we 
determine whether their other payer arrangements are Other Payer 
Advanced APMs starting prior to the 2019 QP Performance Period and each 
year thereafter (82 FR 53854). We codified this policy at Sec.  
414.1445(b)(1).
    We also finalized that the remaining other payers, including 
commercial and other private payers, may request that we determine 
whether other payer arrangements are Other Payer Advanced APMs starting 
prior to the 2020 QP Performance Period and each year thereafter (82 FR 
53867).
    In this section, we are proposing details regarding the Payer 
Initiated Process for the remaining other payers that were not among 
those other payers permitted to use the Payer Initiated Process to 
submit their arrangements for Other Payer Advanced APM Determinations 
in 2018 (Remaining

[[Page 36001]]

Other Payers). To the extent possible, we are aligning the Payer 
Initiated Process for remaining other payers with the previously 
finalized Payer Initiated Process for Medicaid, Medicare Health Plans, 
and CMS Multi-Payer Models.
    In the CY 2018 Quality Payment Program final rule, we finalized 
that the Payer Initiated Process will be voluntary for all payers (82 
FR 53855). We note that the Payer Initiated Process will be similarly 
voluntary for payers that were permitted to submit payment arrangements 
in 2018 and for remaining other payers starting in 2019.
    Guidance and Submission Form: As we have for the other payers 
included in the Payer Initiated Process (82 FR 53874), we intend to 
make guidance available regarding the Payer Initiated Process for 
Remaining Other Payers prior to their first Submission Period, which 
would occur during 2019. We intend to modify the submission form (which 
we refer to as the Payer Initiated Submission Form) for use by 
remaining other payers to request Other Payer Advanced APM 
determinations, and to make this Payer Initiated Submission Form 
available to remaining other payers prior to the first Submission 
Period. We propose that a Remaining Other Payer would be required to 
use the Payer Initiated Submission Form to request that we make an 
Other Payer Advanced APM determination. We intend for the Payer 
Initiated Submission Form to include questions that are applicable to 
all payment arrangements and some questions that are specific to a 
particular type of payment arrangement, and we intend for it to include 
a way for payers to attach supporting documentation. We propose that 
remaining other payers may submit requests for review of multiple other 
payer arrangements through the Payer Initiated Process, though we would 
make separate determinations as to each other payer arrangement and a 
payer would be required to use a separate Payer Initiated Submission 
Form for each other payer arrangement. Remaining other payers may 
submit other payer arrangements with different tracks within that 
arrangement as one request along with information specific to each 
track.
    Submission Period: We propose that the Submission Period for the 
Payer Initiated Process for use by remaining other payers to request 
Other Payer Advanced APM determinations would open on January 1 of the 
calendar year prior to the relevant QP Performance Period for which we 
would make Other Payer Advanced APM determinations. We proposed that 
the Submission Deadline is June 1 of the year prior to the QP 
Performance Period for which we would make the determination.
    The proposed timeline for the Payer Initiated Process for Remaining 
Other Payers as well as the finalized timeline for the Payer Initiated 
Process for Medicaid and Medicare Health Plans, is summarized in Table 
59 alongside the final timeline for the Eligible Clinician Initiated 
Process.

  Table 59--Proposed Other Payer Advanced APM Determination Process for Medicaid, Medicare Health Plans, and Remaining Other Payers for QP Performance
                                                                       Period 2020
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                          Eligible clinician
                                            Payer initiated                       Date                      (EC) initiated                Date
                                                process                                                        process *
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medicaid...............................  Guidance sent to       January 2019...........................  Guidance made         September 2019.
                                          states, then                                                    available to ECs,
                                          Submission Period                                               then Submission
                                          Opens.                                                          Period Opens.
                                         Submission Period      April 2019.............................  Submission Period     November 2019.
                                          Closes.                                                         Closes.
                                         CMS contacts states    September 2019.........................  CMS contacts ECs and  December 2019.
                                          and posts Other                                                 states and posts
                                          Payer Advanced APM                                              Other Payer
                                          List.                                                           Advanced APM List.
Medicare Health Plans..................  Guidance made          April 2019.............................  Guidance made         September 2020.
                                          available to                                                    available to ECs,
                                          Medicare Health                                                 then Submission
                                          Plans, then                                                     Period Opens.
                                          Submission Period
                                          Opens.
                                         Submission Period      June 2019..............................  Submission Period     November 2020.
                                          Closes.                                                         Closes.
                                         CMS contacts Medicare  September 2019.........................  CMS contacts ECs and  December 2020.
                                          Health Plans and                                                Medicare Health
                                          posts Other Payer                                               Plans and posts
                                          Advanced APM List.                                              Other Payer
                                                                                                          Advanced APM List.
Remaining Other Payers.................  Guidance made          January 2019...........................  Guidance made         September 2020.
                                          available to                                                    available to ECs,
                                          Remaining Other                                                 then Submission
                                          Payers, then                                                    Period Opens.
                                          Submission Period
                                          Opens.
                                         Submission Period      June 2019..............................  Submission Period     November 2020.
                                          Closes.                                                         Closes.
                                         CMS contacts           September 2019.........................  CMS contacts ECs and  December 2020.
                                          Remaining Other                                                 Remaining Other
                                          Payers and posts                                                Payers and posts
                                          Other Payer Advanced                                            Other Payer
                                          APM List.                                                       Advanced APM List.
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Note that APM Entities or eligible clinicians may use the Eligible Clinician Initiated Process.

    CMS Determination: Upon the timely receipt of a Payer Initiated 
Submission Form, we would use the information submitted to determine 
whether the other payer arrangement meets the Other Payer Advanced APM 
criteria. We propose that if we find that the Remaining Other Payer has 
submitted incomplete or inadequate information, we would inform the 
payer and allow them to submit additional information no later than 15 
business days from the date we inform the payer of the need for 
additional information. For each other payer arrangement for which the 
Remaining Other Payer does not submit sufficient information in a 
timely fashion, we would not make a determination in response to that 
request submitted via the Payer Initiated Submission Form. As a result, 
the other payer arrangement would not be considered an Other Payer 
Advanced APM for the year. These determinations are final and not 
subject to reconsideration.
    CMS Notification: We intend to notify Remaining Other Payers of our 
determination for each request as soon as practicable after the 
relevant

[[Page 36002]]

Submission Deadline. We note that Remaining Other Payers may submit 
information regarding an other payer arrangement for a subsequent QP 
Performance Period even if we have determined that the other payer 
arrangement is not an Other Payer Advanced APM for a prior year.
    CMS Posting of Other Payer Advanced APMs: We intend to post on the 
CMS website a list (which we refer to as the Other Payer Advanced APM 
List) of all other payer arrangements that we determine to be Other 
Payer Advanced APMs. Prior to the start of the relevant QP Performance 
Period, we intend to post the Other Payer Advanced APMs that we 
determine through the Payer Initiated Process and Other Payer Advanced 
APMs under Title XIX that we determine through the Eligible Clinician 
Initiated Process. After the QP Performance Period, we would update 
this list to include Other Payer Advanced APMs that we determine based 
on other requests through the Eligible Clinician Initiated Process. We 
intend to post the list of other payer arrangements that we determine 
to be Other Payer Advanced APMs through the Payer Initiated Process 
prior to the start of the relevant QP Performance Period, and then to 
update the list to include Other Payer Advanced APMs that we determine 
based on requests received through the Eligible Clinician Initiated 
Process.
(d) Payer Initiated Process--CMS Multi-Payer Models
    In the CY 2018 Quality Payment Program final rule, we finalized 
that beginning for the first QP Performance Period under the All-Payer 
Combination Option, payers with a payment arrangement aligned with a 
CMS Multi-Payer Model may request that we determine whether that 
aligned payment arrangement is an Other Payer Advanced APM.
    We are proposing to eliminate the Payer Initiated Process and 
submission form that are specifically for CMS Multi-Payer Models. We 
believe that payers aligned with CMS Multi-Payer Models can submit 
their arrangements through the Payer Initiated Process for Remaining 
Other Payers we have proposed in section III.H.4.g.(3)(c) of this 
proposed rule, or through the existing Medicaid or Medicare Health Plan 
payment arrangement submission process, as applicable.
    In the first year of implementing the Payer Initiated Process, we 
intentionally limited the types of payers that could use the process to 
Medicaid, Medicare Health Plans, and CMS Multi-Payer Models. We limited 
the types of other payers that could use the Payer Initiated Process so 
as to limit the volume of submissions in our first year of 
implementation, and chose to include payers that already have a 
programmatic or contractual relationship with CMS. Payers in the 
category of CMS Multi-Payer Models may be Medicaid, Medicare Health 
Plans, or commercial payers who have partnered with CMS in the 
development of some of our Advanced APMs.
    In eliminating the Payer Initiated Process and submission form 
specifically for CMS Multi-Payer Models, we are not prohibiting any of 
these payers from submitting payment arrangements to request that CMS 
make Other Payer Advanced APM determinations. Rather, we are providing 
a process for them within larger categories of the Payer Initiated 
Process, whether as commercial payers, or as arrangements under 
Medicaid or Medicare Health Plans. We note that the policies proposed 
for the Payer Initiated Process for Remaining Other Payers, including 
the timeframe, deadlines, and submission form are substantially similar 
or identical to those policies finalized for Payer Initiated Process 
for payment arrangements under Medicaid and Medicare Health Plans.
(4) Calculation of All-Payer Combination Option Threshold Scores and QP 
Determinations
(a) Overview
    In the CY 2017 Quality Payment Program final rule, we finalized our 
overall approach to the All-Payer Combination Option (81 FR 77463). 
Beginning in 2021, in addition to the Medicare Option, an eligible 
clinician may alternatively become a QP through the All-Payer 
Combination Option, and an eligible clinician need only meet the QP 
threshold under one of the two options to be a QP for the payment year 
(81 FR 77459). We finalized that we will conduct the QP determination 
sequentially so that the Medicare Option is applied before the All-
Payer Combination Option (81 FR 77459).
    In the CY 2017 Quality Payment Program final rule, we finalized 
that we will calculate Threshold Scores under the Medicare Option 
through both the payment amount and the patient count methods, compare 
each Threshold Score to the relevant QP and Partial QP Thresholds, and 
use the most advantageous scores to make QP determinations (81 FR 
77457). We finalized the same approach for the All-Payer Combination 
Option wherein we will use the most advantageous method for QP 
determinations with the data that has been provided (81 FR 77475).
(b) QP Determinations Under the All-Payer Combination Option
    In the CY 2018 Quality Payment Program final rule, we finalized 
that an eligible clinician may request a QP determination at the 
eligible clinician level, and that an APM Entity may request a QP 
determination at the APM Entity Level (82 FR 53880 through 53881). In 
the event that we receive a request for QP determination from an 
individual eligible clinician and also separately from that individual 
eligible clinician's APM Entity, we would make a determination at both 
levels. The eligible clinician could become a QP on the basis of either 
of the two determinations (82 FR 53881).
    We sought comment on whether in future rulemaking we should add a 
third alternative to allow QP determinations at the TIN level when all 
clinicians who have reassigned billing rights to the TIN are included 
in a single APM Entity. In particular, we sought comment on whether 
submitting information to request QP determinations under the All-Payer 
Combination Option at the TIN level would more closely align with 
eligible clinicians' existing billing and recordkeeping practices, and 
thereby be less burdensome (82 FR 53881).
    We received several comments asking that we add a third alternative 
to allow requests for QP determinations at the TIN level. These 
commenters remarked that TIN-level requests and determinations would 
align with how payers often contract with practices (that is, at the 
TIN level), as well as encourage alignment between TIN-level Medicare 
and Other Payer Advanced APMs, minimize data reporting burden, and 
promote team-based care.
    After considering these comments, and in the interest of increasing 
flexibility under the All-Payer Combination Option, we are proposing to 
add a third alternative to allow requests for QP determinations at the 
TIN level in instances where all clinicians who have reassigned billing 
rights under the TIN participate in a single APM Entity. This option 
would therefore be available to all TINs participating in Full TIN 
APMs, such as the Medicare Shared Savings Program. It would also be 
available to any other TIN for which all clinicians who have reassigned 
their billing rights to the TIN are participating in a single APM 
Entity.
    We are proposing that, similar to our existing policies for 
individual and APM Entity requests for QP determinations under the All-
Payer Combination Option, we would assess

[[Page 36003]]

QP status based on the most advantageous result for each individual 
eligible clinician. That is, if we receive any combination of QP 
determination requests (at the TIN-level, APM Entity level, or 
individual level) we would make QP assessments at all requested levels 
and determine QP status on the basis of the QP assessment that is most 
advantageous to the eligible clinician.
    We are proposing to revise our regulations at Sec.  414.1440(d), to 
add this third alternative to allow QP determinations at the TIN level 
in instances where all clinicians who have reassigned billing rights to 
the TIN participate in a single APM Entity, and to assess QP status 
based on the most advantageous result for each eligible clinician.
    We are further proposing to allow TIN level requests for QP 
determinations only in instances where the entire TIN has met the 
Medicare threshold for the All-Payer Combination Option based on their 
participation in Advanced APMs, by virtue of their participation in a 
single Advanced APM entity. This is by definition not the case in 
scenarios where an eligible clinician meets the Medicare threshold for 
the All-Payer Combination Option individually, and therefore we would 
not allow TIN level request for QP determinations in such scenarios.
    We believe that adding the third alternative as proposed would 
provide more flexibility for eligible clinicians to attain QP status 
and go further toward reflecting the way that payers typically contract 
with eligible clinicians. We believe that having three possible levels 
for QP determinations would likely increase the opportunities of 
eligible clinicians to attain QP status. Further, we believe this 
proposal would reduce burdens on eligible clinicians who frequently 
contract, bill, and report data at the TIN level. This reduction in 
burden may encourage increased participation in Other Payer Advanced 
APMs.
(c) Use of Individual or APM Entity Group Information for Medicare 
Payment Amount and Patient Count Calculation Under the All-Payer 
Combination Option
(i) Flexibility in the Medicare Option and All-Payer Combination Option 
Threshold Methods
    In the CY 2018 Quality Payment Program final rule, we finalized 
that when we make QP determinations at the individual eligible 
clinician level, we would use the individual eligible clinician payment 
amounts and patient counts for the Medicare calculations in the All-
Payer Combination Option. When we make QP determinations at the APM 
Entity level, we will use APM Entity level payment amounts and patient 
counts for the Medicare calculations in QP determinations under the 
All-Payer Combination Option. Eligible clinicians assessed at the 
individual eligible clinician level under the Medicare Option at Sec.  
414.1425(b)(2) will be assessed at the individual eligible clinician 
level only under the All-Payer Combination Option. We codified these 
policies at Sec.  414.1440(d)(2) (82 FR 53881).
    Based on comments from stakeholders, we believe there may be some 
remaining confusion on the relationship between the payment amount and 
patient count thresholds in the context of the All Payer Combination 
Option. Therefore, we are reiterating our policy that the minimum 
Medicare threshold needed to qualify for a QP determination for the 
All-Payer Combination Option may be calculated based on either payment 
amounts or patient counts (whichever is more favorable to the 
clinician); and that the All-Payer threshold, which includes Medicare 
data, may then be calculated based on either payment amounts or patient 
counts, regardless of which method was used for the initial Medicare 
threshold calculation and that we would similarly use whichever is more 
favorable to the clinician. Some have read our regulation at Sec.  
414.1440(d)(2) to suggest that consistency is required across the two 
thresholds requiring eligible clinicians or APM Entities to meet the 
minimum Medicare threshold needed to qualify for the All-Payer 
Combination Option and the All-Payer threshold using the same method--
either payment amounts or patient counts. Although we did not directly 
address this specific question in our current regulation or in prior 
rulemaking, we are clarifying that eligible clinicians or APM Entities 
can meet the minimum Medicare threshold for the All-Payer Combination 
Option using one method (whichever is most favorable), and the All-
Payer threshold for the All-Payer Combination Option using either the 
same, or the other method. All data submitted to us for Other Payer 
Advanced APM determinations and, when applicable, QP determinations 
using the All-Payer Combination Option will be considered and 
evaluated; and eligible clinicians (or APM Entities or TINs, as 
appropriate) may submit all data relating to both the payment amount 
and patient count methods.
    To avoid any potential ambiguity for the future, we are proposing a 
change to our regulation at Sec.  414.1440(d) to codify this 
clarification. We propose to add a new Sec.  414.1440(d)(4) to 
expressly allow eligible clinicians or APM Entities to meet the minimum 
Medicare threshold using the most favorable of the payment amount or 
patient count method, and then to meet the All-Payer threshold using 
either the same method or the other method.
    We believe this clarification will encourage the submission of more 
complete data with All-Payer Combination Option QP determination 
requests, maximize the number of QPs, and thereby encourage 
participation by eligible clinicians in Advanced APMs and Other Payer 
Advanced APMs by always using the calculation method most favorable to 
the clinician. Further, we believe the codification of this 
clarification in our regulation would maximize flexibility while 
reducing potential uncertainty.
(ii) Extending the Medicare Threshold Score Weighting Methodology to 
TIN Level All-Payer Combination Option Threshold Score Calculations
    In the CY 2018 Quality Payment Program final rule, we explained 
that we recognize that in many cases an individual eligible clinician's 
Medicare Threshold Scores would likely differ from the corresponding 
Threshold Scores calculated at the APM Entity group level, which would 
benefit those eligible clinicians whose individual Threshold Scores 
would be higher than the group Threshold Scores and disadvantage those 
eligible clinicians whose individual Threshold Scores are equal to or 
lower than the group Threshold Scores (82 FR 53881-53882). In 
situations where eligible clinicians are assessed under the Medicare 
Option as an APM Entity group, and receive a Medicare Threshold Score 
at the APM Entity group level, we believe that the Medicare portion of 
their All-Payer calculation under the All-Payer Combination Option 
should not be lower than the Medicare Threshold Score that they 
received by participating in an APM Entity group.
    To accomplish this outcome, we finalized a modified weighting 
methodology. We finalized that when the eligible clinician's Medicare 
Threshold Score calculated at the individual level would be lower than 
the one calculated at the APM Entity group level, we would apply a 
weighting methodology to calculate the Threshold Score for the eligible 
clinician. This methodology allows us to apply the APM Entity group 
level Medicare Threshold Score (if higher than the individual eligible 
clinician

[[Page 36004]]

level Medicare Threshold Score), to the eligible clinician, under 
either the payment amount or patient count method, but weighted to 
reflect the individual eligible clinician's Medicare volume. We 
multiply the eligible clinician's APM Entity group Medicare Threshold 
Score by the total Medicare payments or patients made to that eligible 
clinician as follows:
[GRAPHIC] [TIFF OMITTED] TP27JY18.046

    We propose to extend the same weighting methodology to TIN level 
Medicare Threshold Scores in situations where a TIN is assessed under 
the Medicare Option as part of an APM Entity group, and receives a 
Medicare Threshold Score at the APM Entity group level. In this 
scenario, we believe that the Medicare portion of the TIN's All-Payer 
Combination Option Threshold Score should not be lower than the 
Medicare Threshold Score that they received by participating in an APM 
Entity group (82 FR 53881-53882). We note this extension of the 
weighting methodology would only apply to a TIN when that TIN 
represents a subset of the eligible clinicians in the APM Entity, 
because when the TIN and the APM Entity are the same there is no need 
for this weighted methodology. We would multiply the TIN's APM Entity 
group Medicare Threshold Score by the total Medicare payments or 
patients for that TIN as follows:
[GRAPHIC] [TIFF OMITTED] TP27JY18.047

As an example of how this weighting methodology would apply under the 
payment amount method for payment year 2021, consider the following APM 
Entity group with two TINs, one of which participates in Other Payer 
Advanced APMs and one which does not.

                         Table 60--Weighting Methodology Example--Payment Amount Method
----------------------------------------------------------------------------------------------------------------
                                             Medicare--                         Other payer--
                                            advanced APM    Medicare-- total    Advanced APM      Other payer--
                                              payments          payments          payments       total payments
----------------------------------------------------------------------------------------------------------------
TIN A...................................              $150              $200                $0              $500
TIN B...................................               150               800               760             1,200
APM Entity..............................               300             1,000
----------------------------------------------------------------------------------------------------------------

    In this example, the APM Entity group Medicare Threshold Score is 
$300/$1,000, or 30 percent. Eligible Clinicians in TIN A and B would 
not be QPs under the Medicare Option, but TIN B could request that we 
make a QP determination under the All-Payer Combination Option since 
the APM Entity group exceeded the 25 percent minimum Medicare payment 
amount threshold under that option.
    If we calculate the TIN's payments on its own without the proposed 
weighting policy, we would calculate the Threshold Score as follows:
[GRAPHIC] [TIFF OMITTED] TP27JY18.048

Because TIN B's Threshold Score is less than the 50 percent QP Payment 
Amount Threshold, TIN B would not meet the QP Threshold based on this 
result. However, if we apply the weighting methodology, we would 
calculate the Threshold Score as follows:
[GRAPHIC] [TIFF OMITTED] TP27JY18.049

Based upon this Threshold Score, TIN B would meet the QP Threshold 
under the All-Payer Combination Option.
    We propose to calculate the TIN's Threshold Scores both on its own 
and with this weighted methodology, and then use the most advantageous 
score when making a QP determination. We believe that, as it does for 
QP determinations made at the APM Entity level, this approach promotes 
consistency between the Medicare Option and the All-Payer Combination 
Option to the extent possible. Additionally, the proposed application 
of this weighting approach in the case of a TIN level QP determination 
would

[[Page 36005]]

be consistent with our established policy.
(5) Summary of Proposals
    In this section, we propose the following policies:
Other Payer Advanced APM Criteria
     We are proposing to change the CEHRT use criterion so that 
in order to qualify as an Other Payer Advanced APM as of January 1, 
2020, the percentage of eligible clinicians participating in the other 
payer arrangement who are using CEHRT must be 75 percent.
     We are proposing to allow payers and eligible clinicians 
to submit evidence as part of their request for an Other Payer Advanced 
APM determination that CEHRT is used by the requisite percentage of 
eligible clinicians participating in the payment arrangement (50 
percent for 2019, and 75 percent for 2020 and beyond) to document and 
communicate clinical care, whether or not CEHRT use is explicitly 
required under the terms of the payment arrangement.
     We are proposing the following clarification to Sec.  
414.1420(c)(2), effective January 1, 2020, to provide that at least one 
of the quality measures used in the payment arrangement in paragraph 
(c)(1) of this regulation must be:
    ++ Finalized on the MIPS final list of measures, as described in 
Sec.  414.1330;
    ++ Endorsed by a consensus-based entity; or
    ++ Determined by CMS to be evidenced-based, reliable, and valid.
     We are proposing to revise Sec.  414.1420(c)(3) to require 
that, effective January 1, 2020, unless there is no applicable outcome 
measure on the MIPS quality measure list, an Other Payer Advanced APM 
must use an outcome measure, that meets the proposed criteria in 
paragraph (c)(2) of this regulation.
     We are also proposing at Sec.  414.1420(c)(3)(i) that, for 
payment arrangements determined to be Other Payer Advanced APMs for the 
2019 performance year which did not include an outcome measure that is 
evidence-based, reliable, and valid, that are resubmitted for an Other 
Payer Advanced APM determination for the 2020 performance year (whether 
for a single year, or for a multi-year determination as proposed in 
section III.H.4.g.(3)(b) of this proposed rule), we would continue to 
apply the current regulation for purposes of those determinations. This 
proposed revision also applies to payment arrangements in existence 
prior to the 2020 performance year that are submitted for determination 
to be Other Payer Advanced APMs for the 2020 performance year and 
later.
Determination of Other Payer Advanced APMs
     We are proposing details regarding the Payer Initiated 
Process for remaining other payers. To the extent possible, we are 
aligning the Payer Initiated Process for remaining other payers with 
the previously finalized Payer Initiated Process for Medicaid, Medicare 
Health Plans, and CMS Multi-Payer Models.
     We are proposing to eliminate the Payer Initiated Process 
that is specifically for CMS Multi-Payer Models. We believe that payers 
aligned with CMS Multi-Payer Models can submit their arrangements 
through the Payer Initiated Process for Remaining Other Payers proposed 
in section III.H.4.g.(3)(c) of this proposed rule, or through the 
Medicaid or Medicare Health Plan payment arrangement submission 
processes.
Calculation of All-Payer Combination Option Threshold Scores and QP 
Determinations
     We propose to add a third alternative to allow requests 
for QP determinations at the TIN level in instances where all 
clinicians who reassigned billing rights under the TIN participate in a 
single APM Entity. We propose to modify our regulation at Sec.  
414.1440(d), by adding this third alternative to allow QP 
determinations at the TIN level in instances where all clinicians who 
have reassigned billing under the TIN participate in a single APM 
Entity, as well as to assess QP status at the most advantageous level 
for each eligible clinician.
     We are also clarifying that, in making QP determinations 
using the All-Payer Combination Option, eligible clinicians may meet 
the minimum Medicare threshold using one method, and the All-Payer 
threshold using the same or a different method. We are proposing to 
codify this clarification by adding Sec.  414.1440(d)(4).
     We propose to extend the weighting methodology that is 
used to ensure that an eligible clinician does not receive a lower 
score on the Medicare portion of their all-payer calculation under the 
All-Payer Combination Option than the Medicare Threshold Score they 
received at the APM Entity level in order to apply a similar policy to 
the proposed TIN level Medicare Threshold Scores. We would use this 
methodology only in situations where a TIN is assessed under the 
Medicare Option as part of an APM Entity group, and receives a Medicare 
Threshold Score at the APM Entity group level.
5. Quality Payment Program Technical Correction: Regulation Text 
Changes
    We are proposing certain technical revisions to our regulations in 
order to correct several technical errors and to reconcile the text of 
several of our regulations with the final policies we adopted through 
notice and comment rulemaking.
    We are proposing a technical revision to Sec.  414.1415(b)(1) of 
our regulations to specify that an Advanced APM must require quality 
measure performance as a factor when determining payment to 
participants for covered professional services under the terms of the 
APM. The addition of the word ``quality'' better aligns with section 
1833(z)(3)(D) of the Act and with the policy that was finalized in the 
CY 2017 Quality Payment Program final rule (81 FR 77406), and corrects 
a clerical error we made in the course of revising the text of Sec.  
414.1415(b)(1) for inclusion in the CY 2017 QPP final rule. This 
proposed revision would not change our current policy for this Advanced 
APM criterion.
    We are also proposing technical revisions to the regulation at 
Sec.  414.1420(d)(3)(ii)(B). These changes align with the generally 
applicable nominal amount standard for Other Payer Advanced APMs that 
was finalized in the CY 2017 Quality Payment Program final rule, and 
the change to the generally applicable nominal amount standard in the 
CY 2018 Quality Payment Program final rule where we established a 
revenue-based nominal amount standard as part of the Other Payer 
Advanced APM criteria (82 FR 53849-53850). We finalized that a payment 
arrangement must require APM Entities to bear financial risk for at 
least 3 percent of the expected expenditures for which an APM Entity is 
responsible under the payment arrangement, and that a payment 
arrangement's level of marginal risk must be at least 30 percent of 
losses in excess of the expected expenditures, and the maximum 
allowable minimum loss rate must be 4 percent (81 FR 77471). Due to a 
clerical oversight, we inadvertently published two conflicting 
provisions in regulation text; at Sec.  414.1420(d)(3)(i), we correctly 
finalized that a payment arrangement must require APM Entities to bear 
financial risk for at least 3 percent of the expected expenditures for 
which an APM Entity is responsible under the payment arrangement, and 
at Sec.  414.1420(d)(3)(ii)(B) we incorrectly finalized that the risk 
arrangement must have a total potential risk of at least 4

[[Page 36006]]

percent of expected expenditures. We are effectuating this change by 
removing the Other Payer Advanced APM Criteria, Financial Risk, 
Generally Applicable Nominal Amount Standard provision at Sec.  
414.1420(d)(3)(ii)(B) and consolidating Sec.  414.1420(d)(3)(ii)(A) 
into Sec.  414.1420(d)(3)(ii).
    We are proposing to revise the regulations at Sec. Sec.  
414.1415(c) and 414.1420(d). In the CY 2017 Quality Payment Program 
final rule, we finalized a capitation standard for the financial risk 
criterion under the Advanced APM Criteria and the Other Payer Advanced 
APM Criteria, respectively. We finalized that full capitation 
arrangements would meet the Advanced APM financial risk criterion and 
Other Payer Advanced APM financial risk criterion, and would not 
separately need to meet the generally applicable financial risk 
standard and generally applicable nominal amount standard in order to 
satisfy the financial risk criterion for Advanced APMs and Other Payer 
Advanced APMs (81 FR 77431; 77472). We believe the application of the 
capitation standard as described by this regulation could be made 
clearer by revising Sec. Sec.  414.1415(c) and 414.1420(d) to refer to 
the full capitation exception that is expressed in paragraphs (c)(6) 
and (d)(7), respectively.
    We are also proposing to revise Sec. Sec.  414.1415(c)(6) and 
414.1420(d)(7). In finalizing Sec. Sec.  414.1415(c)(6) and 
414.1420(d)(7), we specified that a capitation arrangement means a 
payment arrangement in which a per capita or otherwise predetermined 
payment is made under the APM for all items and services for which 
payment is made through the APM furnished to a population of 
beneficiaries, and no settlement is performed to reconcile or share 
losses incurred or savings earned by the APM Entity. This language does 
not completely reflect our definition of capitation risk arrangements 
as discussed in preamble at 81 FR 77430 where we state that, 
``capitation risk arrangements, as defined here, involve full risk for 
the population of beneficiaries covered by the arrangement, recognizing 
that it might require no services whatsoever or could require 
exponentially more services than were expected in calculating the 
capitation rate. . . . [a] capitation risk arrangement adheres to the 
idea of a global budget for all items and services to a population of 
beneficiaries during a fixed period of time.'' We propose to revise 
these regulations to align the Advanced APM Criteria, Financial Risk, 
Capitation provision at Sec.  414.1415(c)(6), and the Other Payer 
Advanced APM Criteria, Financial Risk, Capitation provision at Sec.  
414.1420(d)(7) with the definition of capitation risk arrangements that 
we expressed in the preamble of the CY 2017 Quality Payment Program 
final rule at 81 FR 77430-77431.
    We are also proposing a technical correction to remove the ``; or'' 
and replace it with a ``.'' at Sec.  414.1420(d)(3)(i) because the 
paragraph that follows that section does not specify a standard that is 
necessarily an alternative to the standard under Sec.  
414.1420(d)(3)(i), but rather expresses a standard that is independent 
of the standard under Sec.  414.1420(d)(3)(i). As indicated in the CY 
2018 Quality Payment Program final rule at 82 FR 53849-53850, where we 
established a revenue-based nominal amount standard for Other Payer 
Advanced APMs, in order to meet the generally applicable nominal amount 
standard under the Other Payer Advanced APM criteria, the total amount 
that an APM Entity potentially owes the payer or foregoes under a 
payment arrangement must be equal to at least: for the 2019 and 2020 QP 
Performance Periods, 8 percent of the total combined revenues from the 
payer to providers and other entities under the payment arrangement; 
or, 3 percent of the expected expenditures for which an APM Entity is 
responsible under the payment arrangement.
    We are also proposing to amend the regulation at Sec.  
414.1440(d)(3) to correct a typographical error by replacing the 
``are'' with ``is'' in the third clause of the second sentence.

IV. Requests for Information

    This section addresses two requests for information (RFIs). Upon 
reviewing the RFIs, respondents are encouraged to provide complete but 
concise responses. These RFIs are issued solely for information and 
planning purposes; neither RFI constitutes a Request for Proposal 
(RFP), application, proposal abstract, or quotation. The RFIs do not 
commit the U.S. Government to contract for any supplies or services or 
make a grant award. Further, CMS is not seeking proposals through these 
RFIs and will not accept unsolicited proposals. Responders are advised 
that the U.S. Government will not pay for any information or 
administrative costs incurred in response to these RFIs; all costs 
associated with responding to these RFIs will be solely at the 
interested party's expense. Failing to respond to either RFI will not 
preclude participation in any future procurement, if conducted. It is 
the responsibility of the potential responders to monitor each RFI 
announcement for additional information pertaining to the request. 
Please note that CMS will not respond to questions about the policy 
issues raised in these RFIs. CMS may or may not choose to contact 
individual responders. Such communications would only serve to further 
clarify written responses. Contractor support personnel may be used to 
review RFI responses. Responses to these RFIs are not offers and cannot 
be accepted by the U.S. Government to form a binding contract or issue 
a grant. Information obtained as a result of these RFIs may be used by 
the U.S. Government for program planning on a non-attribution basis. 
Respondents should not include any information that might be considered 
proprietary or confidential. These RFIs should not be construed as a 
commitment or authorization to incur cost for which reimbursement would 
be required or sought. All submissions become U.S. Government property 
and will not be returned. CMS may publically post the comments 
received, or a summary thereof.

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

    Currently, Medicare- and Medicaid-participating providers and 
suppliers are at varying stages of adoption of health information 
technology (health IT). Many hospitals have adopted electronic health 
records (EHRs), and CMS has provided incentive payments to eligible 
hospitals, critical access hospitals (CAHs), and eligible professionals 
who have demonstrated meaningful use of certified EHR technology 
(CEHRT) under the Medicare EHR Incentive Program. As of 2015, 96 
percent of Medicare- and Medicaid-participating non-Federal acute care 
hospitals had adopted certified EHRs with the capability to 
electronically export a summary of clinical care.\36\ While both 
adoption of EHRs and electronic exchange of information have grown 
substantially among hospitals, significant obstacles to exchanging 
electronic health information across the continuum of care persist. 
Routine electronic transfer of information post-discharge has not been 
achieved by providers and suppliers in many

[[Page 36007]]

localities and regions throughout the Nation.
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    \36\ These statistics can be accessed at https://dashboard.healthit.gov/quickstats/pages/FIG-Hospital-EHR-Adoption.php.
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    CMS is firmly committed to the use of certified health IT and 
interoperable EHR systems for electronic healthcare information 
exchange to effectively help hospitals and other Medicare- and 
Medicaid-participating providers and suppliers improve internal care 
delivery practices, support the exchange of important information 
across care team members during transitions of care, and enable 
reporting of electronically specified clinical quality measures 
(eCQMs). The Office of the National Coordinator for Health Information 
Technology (ONC) acts as the principal Federal entity charged with 
coordination of nationwide efforts to implement and use health 
information technology and the electronic exchange of health 
information on behalf of the Department of Health and Human Services.
    In 2015, ONC finalized the 2015 Edition health IT certification 
criteria (2015 Edition), the most recent criteria for health IT to be 
certified to under the ONC Health IT Certification Program. The 2015 
Edition facilitates greater interoperability for several clinical 
health information purposes and enables health information exchange 
through new and enhanced certification criteria, standards, and 
implementation specifications. CMS requires eligible hospitals and CAHs 
in the Medicare and Medicaid EHR Incentive Programs and eligible 
clinicians in the Quality Payment Program (QPP) to use EHR technology 
certified to the 2015 Edition beginning in CY 2019.
    In addition, several important initiatives will be implemented over 
the next several years to provide hospitals and other participating 
providers and suppliers with access to robust infrastructure that will 
enable routine electronic exchange of health information. Section 4003 
of the 21st Century Cures Act (Pub. L. 114-255), enacted in 2016, and 
amending section 3000 of the Public Health Service Act (42 U.S.C. 
300jj), requires HHS to take steps to advance the electronic exchange 
of health information and interoperability for participating providers 
and suppliers in various settings across the care continuum. 
Specifically, Congress directed that ONC ``. . . for the purpose of 
ensuring full network-to-network exchange of health information, 
convene public-private and public-public partnerships to build 
consensus and develop or support a trusted exchange framework, 
including a common agreement among health information networks 
nationally.'' In January 2018, ONC released a draft version of its 
proposal for the Trusted Exchange Framework and Common Agreement,\37\ 
which outlines principles and minimum terms and conditions for trusted 
exchange to enable interoperability across disparate health information 
networks (HINs). The Trusted Exchange Framework (TEF) is focused on 
achieving the following four important outcomes in the long-term:
---------------------------------------------------------------------------

    \37\ The draft version of the trusted Exchange Framework may be 
accessed at https://beta.healthit.gov/topic/interoperability/trusted-exchange-framework-and-common-agreement.
---------------------------------------------------------------------------

     Professional care providers, who deliver care across the 
continuum, can access health information about their patients, 
regardless of where the patient received care.
     Patients can find all of their health information from 
across the care continuum, even if they do not remember the name of the 
professional care provider they saw.
     Professional care providers and health systems, as well as 
public and private health care organizations and public and private 
payer organizations accountable for managing benefits and the health of 
populations, can receive necessary and appropriate information on 
groups of individuals without having to access one record at a time, 
allowing them to analyze population health trends, outcomes, and costs; 
identify at-risk populations; and track progress on quality improvement 
initiatives.
     The health IT community has open and accessible 
application programming interfaces (APIs) to encourage entrepreneurial, 
user-focused innovation that will make health information more 
accessible and improve EHR usability.
    ONC will revise the draft TEF based on public comment and 
ultimately release a final version of the TEF that will subsequently be 
available for adoption by HINs and their participants seeking to 
participate in nationwide health information exchange. The goal for 
stakeholders that participate in, or serve as, a HIN is to ensure that 
participants will have the ability to seamlessly share and receive a 
core set of data from other network participants in accordance with a 
set of permitted purposes and applicable privacy and security 
requirements. Broad adoption of this framework and its associated 
exchange standards is intended to both achieve the outcomes described 
above while creating an environment more conducive to innovation.
    In light of the widespread adoption of EHRs along with the 
increasing availability of health information exchange infrastructure 
predominantly among hospitals, we are interested in hearing from 
stakeholders on how we could use the CMS health and safety standards 
that are required for providers and suppliers participating in the 
Medicare and Medicaid programs (that is, the Conditions of 
Participation (CoPs), Conditions for Coverage (CfCs), and Requirements 
for Participation (RfPs) for Long-Term Care (LTC) Facilities) to 
further advance electronic exchange of information that supports safe, 
effective transitions of care between hospitals and community 
providers. Specifically, CMS might consider revisions to the current 
CMS CoPs for hospitals, such as: Requiring that hospitals transferring 
medically necessary information to another facility upon a patient 
transfer or discharge do so electronically; requiring that hospitals 
electronically send required discharge information to a community 
provider via electronic means if possible and if a community provider 
can be identified; and requiring that hospitals make certain 
information available to patients or a specified third-party 
application (for example, required discharge instructions) via 
electronic means if requested.
    On November 3, 2015, we published a proposed rule (80 FR 68126) to 
implement the provisions of the Improving Medicare Post-Acute Care 
Transformation Act of 2014 (the IMPACT Act) (Pub. L. 113-185) and to 
revise the discharge planning CoP requirements that hospitals 
(including short-term acute care hospitals, long-term care hospitals 
(LTCHs), rehabilitation hospitals, psychiatric hospitals, children's 
hospitals, and cancer hospitals), critical access hospitals (CAHs), and 
home health agencies (HHAs) would need to meet in order to participate 
in the Medicare and Medicaid programs. This proposed rule has not been 
finalized yet. However, several of the proposed requirements directly 
address the issue of communication between providers and between 
providers and patients, as well as the issue of interoperability:
     Hospitals and CAHs would be required to transfer certain 
necessary medical information and a copy of the discharge instructions 
and discharge summary to the patient's practitioner, if the 
practitioner is known and has been clearly identified;
     Hospitals and CAHs would be required to send certain 
necessary medical information to the receiving facility/post-acute care 
providers, at the time of discharge; and
     Hospitals, CAHs, and HHAs would need to comply with the 
IMPACT Act

[[Page 36008]]

requirements that would require hospitals, CAHs, and certain post-acute 
care providers to use data on quality measures and data on resource use 
measures to assist patients during the discharge planning process, 
while taking into account the patient's goals of care and treatment 
preferences.
    We published another proposed rule (81 FR 39448) on June 16, 2016, 
that updated a number of CoP requirements that hospitals and CAHs would 
need to meet in order to participate in the Medicare and Medicaid 
programs. This proposed rule has not been finalized yet. One of the 
proposed hospital CoP revisions in that rule directly addresses the 
issues of communication between providers and patients, patient access 
to their medical records, and interoperability. We proposed that 
patients have the right to access their medical records, upon an oral 
or written request, in the form and format requested by such patients, 
if it is readily producible in such form and format (including in an 
electronic form or format when such medical records are maintained 
electronically); or, if not, in a readable hard copy form or such other 
form and format as agreed to by the facility and the individual, 
including current medical records, within a reasonable timeframe. The 
hospital must not frustrate the legitimate efforts of individuals to 
gain access to their own medical records and must actively seek to meet 
these requests as quickly as its recordkeeping system permits.
    We also published a final rule (81 FR 68688) on October 4, 2016, 
that revised the requirements that LTC facilities must meet to 
participate in the Medicare and Medicaid programs. In this rule, we 
made a number of revisions based on the importance of effective 
communication between providers during transitions of care, such as 
transfers and discharges of residents to other facilities or providers, 
or to home. Among these revisions was a requirement that the 
transferring LTC facility must provide all necessary information to the 
resident's receiving provider, whether it is an acute care hospital, an 
LTCH, a psychiatric facility, another LTC facility, a hospice, a home 
health agency, or another community-based provider or practitioner (42 
CFR 483.15(c)(2)(iii)). We specified that necessary information must 
include the following:
     Contact information of the practitioner responsible for 
the care of the resident;
     Resident representative information including contact 
information;
     Advance directive information;
     Special instructions or precautions for ongoing care;
     The resident's comprehensive care plan goals; and
     All other necessary information, including a copy of the 
resident's discharge or transfer summary and any other documentation to 
ensure a safe and effective transition of care.
    We note that the discharge summary mentioned above must include 
reconciliation of the resident's medications, as well as a 
recapitulation of the resident's stay, a final summary of the 
resident's status, and the post-discharge plan of care. In addition, in 
the preamble to the rule, we encouraged LTC facilities to 
electronically exchange this information if possible and to identify 
opportunities to streamline the collection and exchange of resident 
information by using information that the facility is already capturing 
electronically.
    Additionally, we specifically invite stakeholder feedback on the 
following questions regarding possible new or revised CoPs/CfCs/RfPs 
for interoperability and electronic exchange of health information:
     If CMS were to propose a new CoP/CfC/RfP standard to 
require electronic exchange of medically necessary information, would 
this help to reduce information blocking as defined in section 4004 of 
the 21st Century Cures Act?
     Should CMS propose new CoPs/CfCs/RfPs for hospitals and 
other participating providers and suppliers to ensure a patient's or 
resident's (or his or her caregiver's or representative's) right and 
ability to electronically access his or her health information without 
undue burden? Would existing portals or other electronic means 
currently in use by many hospitals satisfy such a requirement regarding 
patient/resident access as well as interoperability?
     Are new or revised CMS CoPs/CfCs/RfPs for interoperability 
and electronic exchange of health information necessary to ensure 
patients/residents and their treating providers routinely receive 
relevant electronic health information from hospitals on a timely basis 
or will this be achieved in the next few years through existing 
Medicare and Medicaid policies, the implementing regulations related to 
the privacy and security standards of the Health Insurance Portability 
and Accountability Act of 1996 (HIPAA) (Pub. L. 104-91), and 
implementation of relevant policies in the 21st Century Cures Act?
     What would be a reasonable implementation timeframe for 
compliance with new or revised CMS CoPs/CfCs/RfPs for interoperability 
and electronic exchange of health information if CMS were to propose 
and finalize such requirements? Should these requirements have delayed 
implementation dates for specific participating providers and 
suppliers, or types of participating providers and suppliers (for 
example, participating providers and suppliers that are not eligible 
for the Medicare and Medicaid EHR Incentive Programs)?
     Do stakeholders believe that new or revised CMS CoPs/CfCs/
RfPs for interoperability and electronic exchange of health information 
would help improve routine electronic transfer of health information as 
well as overall patient/resident care and safety?
     Under new or revised CoPs/CfCs/RfPs, should non-electronic 
forms of sharing medically necessary information (for example, printed 
copies of patient/resident discharge/transfer summaries shared directly 
with the patient/resident or with the receiving provider or supplier, 
either directly transferred with the patient/resident or by mail or fax 
to the receiving provider or supplier) be permitted to continue if the 
receiving provider, supplier, or patient/resident cannot receive the 
information electronically?
     Are there any other operational or legal considerations 
(for example, implementing regulations related to the HIPAA privacy and 
security standards), obstacles, or barriers that hospitals and other 
providers and suppliers would face in implementing changes to meet new 
or revised interoperability and health information exchange 
requirements under new or revised CMS CoPs/CfCs/RfPs if they are 
proposed and finalized in the future?
     What types of exceptions, if any, to meeting new or 
revised interoperability and health information exchange requirements 
should be allowed under new or revised CMS CoPs/CfCs/RfPs if they are 
proposed and finalized in the future? Should exceptions under the QPP, 
including CEHRT hardship or small practices, be extended to new 
requirements? Would extending such exceptions impact the effectiveness 
of these requirements?
    We would also like to directly address the issue of communication 
between hospitals (as well as the other providers and suppliers across 
the continuum of patient care) and their patients and caregivers. 
MyHealthEData is a government-wide initiative aimed at breaking down 
barriers that contribute to preventing patients from being able to 
access and control their medical records. Privacy and security of 
patient data will be at the center of all CMS

[[Page 36009]]

efforts in this area. CMS must protect the confidentiality of patient 
data, and CMS is completely aligned with the Department of Veterans 
Affairs (VA), the National Institutes of Health (NIH), ONC, and the 
rest of the Federal Government, on this objective.
    While some Medicare beneficiaries have had, for quite some time, 
the ability to download their Medicare claims information, in pdf or 
Excel formats, through the CMS Blue Button platform, the information 
was provided without any context or other information that would help 
beneficiaries understand what the data were really telling them. For 
beneficiaries, their claims information is useless if it is either too 
hard to obtain or, as was the case with the information provided 
through previous versions of Blue Button, hard to understand. In an 
effort to fully contribute to the Federal Government's MyHealthEData 
initiative, CMS developed and launched the new Blue Button 2.0, which 
represents a major step toward giving patients meaningful control of 
their health information in an easy-to-access and understandable way. 
Blue Button 2.0 is a developer-friendly, standards-based application 
programming interface (API) that enables Medicare beneficiaries to 
connect their claims data to secure applications, services, and 
research programs they trust. The possibilities for better care through 
Blue Button 2.0 data are exciting, and might include enabling the 
creation of health dashboards for Medicare beneficiaries to view their 
health information in a single portal, or allowing beneficiaries to 
share complete medication lists with their doctors to prevent dangerous 
drug interactions.
    To fully understand all of these health IT interoperability issues, 
initiatives, and innovations through the lens of its regulatory 
authority, CMS invites members of the public to submit their ideas on 
how best to accomplish the goal of fully interoperable health IT and 
EHR systems for Medicare- and Medicaid-participating providers and 
suppliers, as well as how best to further contribute to and advance the 
MyHealthEData initiative for patients. We are particularly interested 
in identifying fundamental barriers to interoperability and health 
information exchange, including those specific barriers that prevent 
patients from being able to access and control their medical records. 
We also welcome the public's ideas and innovative thoughts on 
addressing these barriers and ultimately removing or reducing them in 
an effective way, specifically through revisions to the current CMS 
CoPs, CfCs, and RfPs for hospitals and other participating providers 
and suppliers. We have received stakeholder input through recent CMS 
Listening Sessions on the need to address health IT adoption and 
interoperability among providers that were not eligible for the 
Medicare and Medicaid EHR Incentives program, including long-term and 
post-acute care providers, behavioral health providers, clinical 
laboratories and social service providers, and we would also welcome 
specific input on how to encourage adoption of certified health IT and 
interoperability among these types of providers and suppliers as well.

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

    In the FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20548 and 20549) 
and the FY 2015 IPPS/LTCH PPS proposed and final rules (79 FR 28169 and 
79 FR 50146, respectively), we stated that we intend to continue to 
review and post relevant charge data in a consumer-friendly way, as we 
previously have done by posting hospital and physician charge 
information on the CMS website.\38\ In the FY 2019 IPPS/LTCH PPS 
proposed rule, we also continued our discussion of the implementation 
of section 2718(e) of the Public Health Service Act, which aims to 
improve the transparency of hospital charges. This discussion in the FY 
2019 IPPS/LTCH PPS proposed rule continued a discussion we began in the 
FY 2015 IPPS/LTCH PPS proposed rule and final rule (79 FR 28169 and 79 
FR 50146, respectively). In all of these rules, we noted that section 
2718(e) of the Public Health Service Act requires that each hospital 
operating within the United States, for each year, establish (and 
update) and make public (in accordance with guidelines developed by the 
Secretary) a list of the hospital's standard charges for items and 
services provided by the hospital, including for diagnosis-related 
groups (DRGs) established under section 1886(d)(4) of the Act. In the 
FY 2015 IPPS/LTCH PPS proposed and final rules, we reminded hospitals 
of their obligation to comply with the provisions of section 2718(e) of 
the Public Health Service Act and provided guidelines for its 
implementation. We stated that hospitals are required to either make 
public a list of their standard charges (whether that be the 
chargemaster itself or in another form of their choice) or their 
policies for allowing the public to view a list of those charges in 
response to an inquiry. In the FY 2019 IPPS/LTCH PPS proposed rule, we 
took one step to further improve the public accessibility of charge 
information. Specifically, effective January 1, 2019, we are updating 
our guidelines to require hospitals to make available a list of their 
current standard charges via the internet in a machine readable format 
and to update this information at least annually, or more often as 
appropriate.
---------------------------------------------------------------------------

    \38\ See, for example, Medicare Provider Utilization and Payment 
Data, available at https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Medicare-Provider-Charge-Data/.
---------------------------------------------------------------------------

    In general, we encourage all providers and suppliers to undertake 
efforts to engage in consumer-friendly communication of their charges 
to help patients understand what their potential financial liability 
might be for services they obtain, and to enable patients to compare 
charges for similar services. We encourage providers and suppliers to 
update this information at least annually, or more often as 
appropriate, to reflect current charges.
    We are concerned that challenges continue to exist for patients due 
to insufficient price transparency. Such challenges include patients 
being surprised by out-of-network bills for physicians, such as 
anesthesiologists and radiologists, who provide services at in-network 
hospitals and in other settings, and patients being surprised by 
facility fees, physician fees for emergency department visits, or by 
fees for providers and suppliers that are part of an episode of care 
but that were not furnished by the hospital. We also are concerned 
that, for providers and suppliers that maintain a list of standard 
charges, the charge data may not be helpful to patients for determining 
what they are likely to pay for a particular service or facility 
encounter. In order to promote greater price transparency for patients, 
we are considering ways to improve the accessibility and usability of 
current charge information.
    We also are considering potential actions that would be appropriate 
to further our objective of having providers and suppliers undertake 
efforts to engage in consumer-friendly communication of their charges 
to help patients understand what their potential financial liability 
might be for services they obtain from the provider or supplier, and to 
enable patients to compare charges for similar services across 
providers and suppliers, including services that could be offered in 
more than one setting. Therefore, we are seeking public comment from 
all providers and suppliers on the following:
     How should we define ``standard charges'' in various 
provider and supplier settings? Is there one definition

[[Page 36010]]

for those settings that maintain chargemasters, and potentially a 
different definition for those settings that do not maintain 
chargemasters? Should ``standard charges'' be defined to mean: Average 
or median rates for the items on a chargemaster or other price list or 
charge list; average or median rates for groups of items and/or 
services commonly billed together, as determined by the provider or 
supplier based on its billing patterns; or the average discount off the 
chargemaster, price list or charge list amount across all payers, 
either for each separately enumerated item or for groups of services 
commonly billed together? Should ``standard charges'' be defined and 
reported for both some measure of the average contracted rate and the 
chargemaster, price list or charge list? Or is the best measure of a 
provider's or supplier's standard charges its chargemaster, price list 
or charge list?
     What types of information would be most beneficial to 
patients, how can providers and suppliers best enable patients to use 
charge and cost information in their decision-making, and how can CMS 
and providers and suppliers help third parties create patient-friendly 
interfaces with these data?
     Should providers and suppliers be required to inform 
patients how much their out-of-pocket costs for a service will be 
before those patients are furnished that service? How can information 
on out-of-pocket costs be provided to better support patients' choice 
and decision-making? What changes would be needed to support greater 
transparency around patient obligations for their out-of-pocket costs? 
How can CMS help beneficiaries to better understand how co-pays and co-
insurance are applied to each service covered by Medicare? What can be 
done to better inform patients of their financial obligations? Should 
providers and suppliers of healthcare services play any role in helping 
to inform patients of what their out-of-pocket obligations will be?
     Can we require providers and suppliers to provide patients 
with information on what Medicare pays for a particular service 
performed by that provider or supplier? If so, what changes would need 
to be made by providers and suppliers? What burden would be added as a 
result of such a requirement?
    In addition, we are seeking public comment on improving a Medigap 
patient's understanding of his or her out-of-pocket costs prior to 
receiving services, especially with respect to the following particular 
questions:
     How does Medigap coverage affect patients' understanding 
of their out-of-pocket costs before they receive care? What challenges 
do providers and suppliers face in providing information about out-of-
pocket costs to patients with Medigap? What changes can Medicare make 
to support providers and suppliers that share out-of-pocket cost 
information with patients that reflects the patient's Medigap coverage? 
Who is best situated to provide patients with clear Medigap coverage 
information on their out-of-pocket costs prior to receipt of care? What 
role can Medigap plans play in providing information to patients on 
their expected out-of-pocket costs for a service? What state-specific 
requirements or programs help educate Medigap patients about their out-
of-pocket costs prior to receipt of care?

V. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. chapter 
35), we are required to publish a 60-day notice in the Federal Register 
and solicit public comment before a collection of information 
requirement is submitted to the Office of Management and Budget (OMB) 
for review and approval.
    To fairly evaluate whether an information collection should be 
approved by OMB, section 3506(c)(2)(A) of the PRA requires that we 
solicit comment on the following issues:
     The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
     The accuracy of our burden estimates.
     The quality, utility, and clarity of the information to be 
collected.
     Our effort to minimize the information collection burden 
on the affected public, including the use of automated collection 
techniques.
    We are soliciting public comment on each of the section 
3506(c)(2)(A) required issues for the following information collection 
requirements (ICRs).

A. Wages

    To derive average costs, we used data from the U.S. Bureau of Labor 
Statistics' May 2017 National Occupational Employment and Wage 
Estimates for all salary estimates (https://www.bls.gov/oes/current/oes_nat.htm). In this regard, Table 61 presents the mean hourly wage, 
the cost of fringe benefits and overhead (calculated at 100 percent of 
salary), and the adjusted hourly wage.
    Private Sector Wages: The adjusted hourly wage is used to calculate 
the labor costs associated with our proposed requirements.

                          Table 61--National Occupational Employment and Wage Estimates
----------------------------------------------------------------------------------------------------------------
                                                                                      Fringe
                                                    Occupation      Mean hourly    benefits and      Adjusted
                Occupation title                       code         wage ($/hr)   overhead costs  hourly wage ($/
                                                                                      ($/hr)            hr)
----------------------------------------------------------------------------------------------------------------
All Occupations (for Individuals' Wages)........         00-0000          $24.34             n/a             n/a
Billing and Posting Clerks......................         43-3021           18.49          $18.49          $36.98
Computer Systems Analysts.......................         15-1121           44.59           44.59           89.18
Family and General Practitioner.................         29-1062          100.27          100.27          200.54
Legal Support Workers, All Other................         23-2099           32.67           32.67           65.34
Licensed Practical Nurse (LPN)..................         29-2061           21.98           21.98           43.96
Medical Secretary...............................         43-6013           17.25           17.25           34.50
Physicians......................................         29-1060          103.22          103.22          206.44
Practice Administrator (Medical and Health               11-9111           53.69           53.69          107.38
 Services Managers).............................
Registered Nurse................................         29-1141           35.36           35.36           70.72
----------------------------------------------------------------------------------------------------------------

    As indicated, we are adjusting our employee hourly wage estimates 
by a factor of 100 percent. This is necessarily a rough adjustment, 
both because fringe benefits and overhead costs vary significantly from 
employer to

[[Page 36011]]

employer, and because methods of estimating these costs vary widely 
from study to study. Nonetheless, there is no practical alternative and 
we believe that doubling the hourly wage to estimate total cost is a 
reasonably accurate estimation method.
    Wages for Individuals: For beneficiaries who elect to complete the 
CAHPS for MIPS survey, we believe that the burden will be addressed 
under All Occupations (BLS occupation code 00-0000) at $24.34/hr since 
the group of individual respondents varies widely from working and 
nonworking individuals and by respondent age, location, years of 
employment, and educational attainment, etc. Unlike our private sector 
adjustment to the respondent hourly wage, we are not adjusting this 
figure for fringe benefits and overhead since the individuals' 
activities would occur outside the scope of their employment.

B. Proposed Information Collection Requirements (ICRs)

1. ICRs Regarding the Clinical Laboratory Fee Schedule (CLFS) (Section 
III.A. of This Proposed Rule)
    Section 1834A of the Act, as established by section 216(a) of the 
Protecting Access to Medicare Act of 2014 (PAMA), required significant 
changes to how Medicare pays for CDLTs under the CLFS. The CLFS final 
rule titled, Medicare Clinical Diagnostic Laboratory Tests Payment 
System final rule (CLFS final rule), published in the Federal Register 
on June 23, 2016, implemented section 1834A of the Act. Under the CLFS 
final rule (81 FR 41036), ``reporting entities'' must report to CMS 
during a ``data reporting period'' ``applicable information'' (that is, 
certain private payor data) collected during a ``data collection 
period'' for their component ``applicable laboratories.'' In general, 
the payment amount for each clinical diagnostic laboratory test (CDLT) 
on the CLFS furnished beginning January 1, 2018, is based on the 
applicable information collected during the 6-month data collection 
period and reported to us during the 3-month data reporting period, and 
is equal to the weighted median of the private payor rates for the 
CDLT.
    An applicable laboratory is defined at Sec.  414.502, in part, as 
an entity that is a laboratory (as defined under the Clinical 
Laboratory Improvement Amendments (CLIA) definition at Sec.  493.2) 
that bills Medicare Part B under its own National Provider Identifier 
(NPI). In addition, an applicable laboratory is an entity that receives 
more than 50 percent of its Medicare revenues during a data collection 
period from the CLFS and/or the Physician Fee Schedule. We refer to 
this component of the applicable laboratory definition as the 
``majority of Medicare revenues threshold.'' The definition of 
applicable laboratory also includes a ``low expenditure threshold'' 
component, which requires an entity to receive at least $12,500 of its 
Medicare revenues from the CLFS during a data collection period for its 
CDLTs that are not advanced diagnostic laboratory tests (ADLTs).
    In determining payment rates under the private payor rate-based 
CLFS, one of our objectives is to obtain as much applicable information 
as possible from the broadest possible representation of the national 
laboratory market on which to base CLFS payment amounts, for example, 
from independent laboratories, hospital outreach laboratories, and 
physician office laboratories, without imposing undue burden on those 
entities. We believe it is important to achieve a balance between 
collecting sufficient data to calculate a weighted median that 
appropriately reflects the private market rate for a CDLT, and 
minimizing the reporting burden for entities. In response to 
stakeholder feedback and in the interest of facilitating our goal, we 
are proposing to revise the majority of Medicare revenues threshold 
component of the definition of applicable laboratory at Sec.  
414.502(3) to exclude Medicare Advantage (MA) payments under Medicare 
Part C from the definition of total Medicare revenues (that is, the 
denominator of the majority of Medicare threshold equation). 
Specifically, the proposed change could allow additional laboratories 
of all types serving a significant population of beneficiaries enrolled 
in Medicare Part C to meet the majority of Medicare revenues threshold 
and potentially qualify as applicable laboratories (if they also meet 
the low expenditure threshold) and report data to us.
    As such, we believe this proposal may result in more data being 
reported, which we would use to set CLFS payment rates. However, with 
regard to the CLFS-related requirements and burden, we note that 
section 1834A(h)(2) of the Act provides that the Paperwork Reduction 
Act in chapter 35 of title 44 of the U.S.C. shall not apply to 
information collected under section 1834A of the Act (which is the new 
private payor rate-based CLFS).
    For a complete discussion of our proposal to revise the majority of 
Medicare revenues threshold component of the definition of applicable 
laboratory under the Medicare CLFS, we refer readers to section III.A 
of this proposed rule.
2. ICRs Regarding Appropriate Use Criteria (AUC) for Advanced 
Diagnostic Imaging Services (Sec.  414.94 and Section III.D. of This 
Proposed Rule)
    Consultations: In this rule we propose to revise the regulation at 
Sec.  414.94(j) to allow the AUC consultation, when not performed 
personally by the ordering professional, to be performed by auxiliary 
personnel (as defined in Sec.  410.26(a)(1)) under the direction of, 
and incident to, the ordering professional's services. The consultation 
requirements and burden will be submitted to OMB for approval under 
control number 0938-1345 (CMS-10654).
    General practitioners make up a large group of practitioners who 
order applicable imaging services and would be required to consult AUC 
under this program so we use ``family and general practitioner'' from 
the list of BLS occupation titles (see Table O1) to calculate the 
following cost estimates. As our proposal would modify the AUC 
consultation requirement to allow auxiliary personnel, working under 
the direction of the ordering professional, to interact with the CDSM 
for AUC consultation, we also use the ``registered nurse'' occupation 
to calculate our revised cost estimates.
    To derive the burden associated with the proposed provision in 
Sec.  414.94(j) that would take effect January 1, 2020, we estimate it 
would take 2 minutes (0.033 hr) at $70.72/hr for auxiliary personnel in 
the form of a registered nurse to consult with a qualified CDSM. The 
Medicare Benefit Policy Manual (Pub. 100-02), Chapter 15, Section 60.2 
IOM 100-02, Chapter 15, Section 60.2 requires that an incidental 
service performed by the nonphysician practitioner must have followed 
from a direct, personal, professional service furnished by the 
physician. Therefore, to estimate the percentage of consultations 
available to be performed incident to, we analyzed 2014 Medicare Part B 
claims comparing evaluation and management visits for new (CPT codes 
99201, 99202, 99203, 99204, and 99205) relative to established (CPT 
codes 99211, 99212, 99213, 99214, 99215) patients with place of service 
codes 11 (physician's office). We found that approximately 10 percent 
of all claims incurred were for new patients. Therefore, we also 
estimate that 90-percent or 38,863,636 of the total consultations 
(43,181,818 total consultations x 0.90) could be performed by such 
auxiliary personnel, with the remaining 10 percent

[[Page 36012]]

(43,181,818 x 0.10) performed by the ordering professional. In 
aggregate, we estimate an annual burden of 1,282,500 hours 
(38,863,636.2 consultations x 0.033 hr/consultation) at a cost of 
$90,698,400 (1,282,500 hr x $70.72/hr) or $2.33 per consultation. If 
this provision is finalized, we would continue to monitor our burden 
estimates and, if necessary, adjust those estimates for more precision 
once the program begins.
    Additionally, the CY 2018 Physician Fee Schedule final rule (82 FR 
52976) explicitly discussed and provided a voluntary period for 
ordering professionals to begin to familiarize themselves with 
qualified CDSMs. During the current 18-month voluntary participation 
period, we estimated there would be 10,230,000 consultations based on 
market research from current applicants for the qualification of their 
CDSMs for advanced diagnostic imaging services. Based on feedback from 
CDSMs with experience in AUC consultation, as well as standards 
recommended by the Office of the National Coordinator (ONC) \39\ and 
the Healthcare Information Management Systems Society (HIMSS) \40\, we 
estimated it would take 2 minutes (0.033 hr) at $200.54/hr for a family 
and general practitioner or 2 minutes at $70.72/hr for a registered 
nurse to use a qualified CDSM to consult specified applicable AUC. As 
mentioned above, we estimate that as many as 90-percent of practices 
would use auxiliary personnel working under the direction of the 
ordering professional to interact with the CDSM for AUC consultation. 
Consequently, we estimate a total burden of 337,590 hours (10,230,000 
consultations x 0.033 hr) at a cost of $28,256,958 ([337,590 hr x 0.10 
x $200.54/hr] + [337,590 hr x 0.90 x $70.72/hr]). Annually, we estimate 
112,530 hours (337,590 hr/3 yr) at a cost of $9,418,986 ($28,256,958/3 
yr). We are annualizing the one-time burden (by dividing our estimates 
by OMB's 3-year approval period) since we do not anticipate any 
additional burden after the 18-month voluntary participation period 
ends.
---------------------------------------------------------------------------

    \39\ https://ecqi.healthit.gov/cds#quicktabs-tabs_cds3.
    \40\ https://www.himss.org/improving-outcomes-cds-practical-pearls-new-himss-guidebook.
---------------------------------------------------------------------------

    Beginning January 1, 2020, we anticipate 43,181,818 responses in 
the form of consultations based on the aforementioned market research, 
as well as Medicare claims data for advanced diagnostic imaging 
services. As noted above, we estimate it would take 2 minutes (0.033 
hr) at $200.54/hr for a family and general practitioner or 2 minutes at 
$70.72/hr for a registered nurse to use a qualified CDSM to consult 
specified applicable AUC. In aggregate, we estimate an annual burden of 
1,425,000 hours (43,181,818 consultations x 0.033 hr/consultation) at a 
cost of $119,275,350 ([0.1 x 1,425,000 hr x $200.54/hr] + [0.9 x 
1,425,000 hr x $70.72/hr]).
    Annual Reporting: Consistent with section 1834(q)(4)(B) of the Act, 
in the CY 2018 PFS final rule (82 FR 52976) we estimated the burden of 
implementing the one-time voluntary reporting period beginning in July 
2018, and will be implementing the mandatory annual reporting 
requirement beginning January 1, 2020. Specifically, the regulation at 
Sec.  [thinsp]414.94(k) requires that Medicare claims for advanced 
diagnostic imaging services, paid for under an applicable payment 
system (as defined in Sec.  414.94(b)) and ordered on or after January 
1, 2020, report the following information: (1) Identify which qualified 
CDSM was consulted by the ordering professional; (2) identify whether 
the service ordered would adhere to specified applicable AUC, would not 
adhere to specified applicable AUC, or whether specified applicable AUC 
was not applicable to the service ordered; and (3) identify the NPI of 
the ordering professional (if different from the furnishing 
professional). The reporting requirement will not have any impact on 
any Medicare claim forms because the forms' currently approved data 
fields, instructions, and burden are not expected to change. 
Consequently, there is no need for review by OMB under the authority of 
the PRA, however, we have assessed the impact and include an analysis 
to this effect in the regulatory impact section of this proposed rule.
    Significant Hardship Exception: We propose to revise the regulation 
at Sec.  414.94(i)(3) that provides for a significant hardship 
exception for ordering professionals who experience a significant 
hardship affecting their consultation of AUC when ordering an advanced 
diagnostic imaging service. The proposed revision would establish a 
process whereby all ordering professionals can self-attest that they 
are experiencing a significant hardship at the time of placing an 
advanced diagnostic imaging order. While this is not a certification 
being used as a substitute for a collection of AUC consultation 
information because no consultation is required by statute to take 
place, the significant hardship exception process would involve 
appending to the order for an applicable imaging service the 
significant hardship information for inclusion on the Medicare claim in 
lieu of the AUC consultation information. This imposes no burden beyond 
the provision of identifying information and attesting to the 
applicable information. In this regard, the use of this process is not 
``information'' as defined under 5 CFR 1320.3(h), and therefore, is 
exempt from requirements of the PRA.
    Recordkeeping: Section 1834(q)(4)(C) of the Act provides for 
certain exceptions to these reporting requirements, therefore we 
believe that some claims for advanced diagnostic imaging services will 
not contain AUC consultation information, such as in the case of an 
ordering professional with a significant hardship. However, ordering 
professionals would store documentation supporting the self-attestation 
of a significant hardship. Storage of this information could involve 
the use of automated, electronic, or other forms of information 
technology at the discretion of the ordering professional. CMS 
estimates that the average time for office clerical activities 
associated with this storage of information to be 10 minutes (0.167 hr) 
at $17.25/hr for a medical secretary to perform 6,699 recordkeeping 
actions, since consultation will not take place in the year when a 
hardship is incurred and 2016 data from the Medicare EHR Incentive 
Program and the first 2019 payment year MIPS eligibility and special 
status file suggests this estimate of those seeking hardship (control 
number 0938-1314). In aggregate we estimate an annual burden of 1,119 
hours (6,699 recordkeeping activities x 0.167 hr) at a cost of $19,303 
(1,119 hr x $17.25/hr). We seek comments to inform these burden 
estimates.
3. ICRs Regarding the Medicare Shared Savings Program (Part 425 and 
Section III.F. of This Proposed Rule)
    Section 1899(e) of the Act provides that chapter 35 of title 44 of 
the U.S. Code, which includes such provisions as the PRA, shall not 
apply to the Shared Savings Program.
4. ICRs Regarding the Physician Self-Referral Law (42 CFR Part 411 and 
Section III.G. of This Proposed Rule)
    Section 1877 of the Act, also known as the physician self-referral 
law: (1) Prohibits a physician from making referrals for certain 
designated health services (DHS) payable by Medicare to an entity with 
which he or she (or an immediate family member) has a financial 
relationship (ownership or compensation), unless an exception applies; 
and (2) prohibits the entity from filing claims with Medicare (or 
billing

[[Page 36013]]

another individual, entity, or third party payer) for those referred 
services. The statute establishes a number of specific exceptions, and 
grants the Secretary the authority to create regulatory exceptions for 
financial relationships that pose no risk of program or patient abuse. 
Additionally, the statute mandates refunding any amount collected under 
a bill for an item or service furnished under a prohibited referral. 
Finally, the statute imposes reporting requirements and provides for 
sanctions, including civil monetary penalty provisions.
    As discussed in section III.G. of this rule, we are proposing 
regulatory updates to implement section 50404 of the Bipartisan Budget 
Act of 2018 (Pub. L. 115-123, enacted February 9, 2018), which added 
provisions to section 1877(h)(1) of the Act pertaining to the writing 
and signature requirements in certain compensation arrangement 
exceptions to the physician self-referral law's referral and billing 
prohibitions. Although we believe that the newly enacted provisions in 
section 1877(h)(1) of the Act are principally intended merely to codify 
in statute existing CMS policy and regulations with respect to 
compliance with the writing and signature requirements, we are 
proposing revisions to our regulations at 42 CFR 411.354(e) and 
411.353(g) to address any actual or perceived difference between the 
statutory and regulatory language, to codify in regulation our 
longstanding policy regarding satisfaction of the writing requirement 
found in many of the exceptions to the physician self-referral law, and 
to make the Bipartisan Budget Act of 2018 policies applicable to 
compensation arrangement exceptions issued using the Secretary's 
authority in section 1877(b)(4) of the Act. The burden associated with 
the writing and signature requirements would be the time and effort 
necessary to prepare written documents and obtain signatures of the 
parties.
    While the writing and signature requirements are subject to the 
PRA, we believe the associated burden is exempt under 5 CFR 
1320.3(b)(2). We believe that the time, effort, and financial resources 
necessary to comply with the writing and signature requirements would 
be incurred by persons without federal regulation during the normal 
course of their activities. Specifically, we believe that, for normal 
business operations purposes, health care providers and suppliers 
document their financial arrangements with physicians and others in 
order to identify and be able to enforce the legal obligations of the 
parties. Therefore, we believe that the writing and signature 
requirements should be considered usual and customary business 
practices.
5. The Quality Payment Program (QPP) (Part 414 and Section III.H. of 
This Proposed Rule)
    Summary: With respect to the PRA, the Quality Payment Program is 
comprised of a series of ICRs associated with MIPS and Advanced APMs. 
The MIPS ICRs consist of registration for virtual groups; qualified 
registry and QCDR self-nomination; CAHPS survey vendor application; 
Quality Payment Program Identity Management Application Process; 
quality performance category data submission by claims collection type, 
QCDR and MIPS CQM collection type, eCQM collection type, and CMS web 
interface submission type; CAHPS for MIPS survey beneficiary 
participation; group registration for CMS web interface; group 
registration for CAHPS for MIPS survey; call for quality measures; 
Promoting Interoperability reweighting applications; Promoting 
Interoperability performance category data submission; call for 
Promoting Interoperability measures; improvement activities performance 
category data submission; nomination of improvement activities; and 
opt-out of Physician Compare for voluntary participants. ICRs for 
Advanced APMs consist of partial qualifying APM participant (QP) 
election; other payer Advanced APM identification: Payer Initiated and 
Eligible Clinician Initiated Processes; and submission of data for All-
Payer QP determinations under the All-Payer combination option.
    The following ICRs reflect this proposed rule's policies, as well 
as policies in the CY 2017 (81 FR 77008) and CY 2018 (82 FR 53568) 
Quality Payment Program final. In discussing each ICR, we reference the 
specific policies and whether they are proposed in this CY 2019 
proposed rule or finalized in the CY 2017 or CY 2018 Quality Payment 
Program final rules. As described below in more detail, two ICRs 
(Quality: CMS Web Interface Submission Type, and Promoting 
Interoperability Performance Category: Data Submission) show a 
reduction in burden due to proposed changes in policies. Most burden 
estimates are adjustments to reflect data available at the time of 
publication of this proposed rule. Finally, we added one ICR to 
incorporate a collection previously mentioned in the CY 2018 Quality 
Payment Program final rule for which collection had not yet started: 
Submission of Data for All-Payer QP Determinations (82 FR 53886). See 
section V.B.4. of this proposed rule for a summary of the ICRs, the 
overall burden estimates, changes in burden due to policies in this 
proposed rule, and a summary of the policy and data changes affecting 
each ICR.
    The revised requirements and burden estimates for all Quality 
Payment Program ICRs (except for CAHPS for MIPS and virtual groups 
election) will be submitted to OMB for approval under control number 
0938-1314 (CMS-10621). The proposed CAHPS for MIPS ICRs will be 
submitted to OMB for approval under control number 0938-1222 (CMS-
10450). The Virtual Groups Election is approved by OMB control number 
0938-1343 (CMS-10652).
    With regard to Quality Payment Program respondents, we selected BLS 
occupations Billing and Postal Clerks, Computer Systems Analysts, 
Physicians, Practice Administrator, and Licensed Practical Nurse (see 
Wage Estimates in section V.A. of this proposed rule) based on a study 
(Casalino et al., 2016) that collected data on the staff in physician's 
practices involved in the quality data submission process.\41\ To 
calculate the cost for virtual groups to prepare their written formal 
agreements, we used wage estimates for Legal Support Workers, All 
Others.
---------------------------------------------------------------------------

    \41\ Lawrence P. Casalino et al., ``US Physician Practices Spend 
More than $15.4 Billion Annually to Report Quality Measures,'' 
Health Affairs, 35, no. 3 (2016): 401-406.
---------------------------------------------------------------------------

    Respondent estimates are modeled using similar methodology to the 
CY 2017 and CY 2018 Quality Payment Program final rules. For instance, 
we are using the eligibility file generated for the MIPS program based 
on the first 12-month determination period for the first year; the APM 
Participation List for the third snapshot date of the 2017 QP 
performance period to identify QP clinicians excluded from MIPS, and to 
identify clinicians and groups eligible for MIPS but who are not 
required to submit data for the Promoting Interoperability performance 
category; and the 2016 PQRS data and 2016 Medicare and Medicaid EHR 
Incentive Program data to estimate the number of respondents for the 
improvement activities performance category. Although the submission 
period for the 2017 MIPS performance period ended in April 2018, the 
participation and performance data were not available at the time of 
writing this proposed rule, with the sole exception of 286 CMS Web 
Interface respondents, which is based on the number of groups who 
submitted MIPS data via the CMS Web Interface during the 2018 MIPS 
performance period. We intend to update our burden

[[Page 36014]]

estimates in the final rule using actual MIPS data if technically 
feasible.
    Our estimates assume clinicians who participated in 2016 PQRS and 
who are not determined to be QPs based on their participation in 
Advanced APMs in the 2017 performance period will continue to submit 
quality data in the 2019 MIPS performance period. This assumption is 
consistent with the CY 2017 and CY 2018 Quality Payment Program final 
rules where we assumed that clinicians would continue to participate as 
either MIPS eligible clinicians or voluntary reporters (81 FR 77501 and 
82 FR 53908). As discussed in section III.H.3.a. of this proposed rule, 
we are proposing to revise the eligibility criteria to expand MIPS to 
additional clinician types. In addition, we are proposing in section 
III.H.3.c. of this proposed rule to revise the low-volume threshold in 
the following manner: If a MIPS eligible clinician meets or exceeds 
one, but not all, of the low-volume threshold criterion, including as 
defined by dollar amount ($90,000), beneficiary count (200), or covered 
professional services to Part-B enrolled individuals (minimum threshold 
of 200) then they may elect to submit data and opt-in to MIPS. If a 
MIPS eligible clinician does not meet at least one of these low-volume 
determinations or does not elect to opt-in, they are not eligible and 
are excluded from MIPS. If they are excluded and submit data, they 
would be voluntary reporters. If these policies are finalized, it would 
expand the number of potential MIPS eligible clinicians, but we do not 
anticipate an incremental increase in the burden because the affected 
clinicians were assumed to be voluntary reporters in prior rules. In 
the CY 2018 Quality Payment Program final rule, clinicians who 
participated in 2016 PQRS, and who were not determined to be QPs based 
on their participation in Advanced APMs during CY 2017 and were not 
MIPS eligible, were assumed to be voluntary reporters in MIPS (82 FR 
53908). Therefore, the proposed expansion in MIPS eligibility does not 
change the total number of respondents, but instead shifts a certain 
number of assumed voluntary reporters to MIPS eligible clinicians.
    Additionally, we expect the act of electing to be a single click 
once a clinician or group has submitted data; therefore, we do not 
anticipate that proposal would revise the burden hours for any of our 
burden estimates.
    Our participation estimates are reflected in Tables 65, 66, and 67 
for the quality performance category, Table 78 for the Promoting 
Interoperability performance category, and Table 81 for the improvement 
activities performance category. We also assume that previous PQRS 
participants who are not QPs will submit data for the improvement 
activities performance category, and will submit data for the Promoting 
Interoperability performance category unless they receive a significant 
hardship or other type of exception or are automatically assigned a 
weighting of zero percent for the Promoting Interoperability 
performance category.
    Due to data limitations, our burden estimates may overstate the 
total burden for data submission under the quality, Promoting 
Interoperability, and improvement activities performance categories. 
This is due to two primary reasons. First, we anticipate the number of 
QPs to increase because of total expected growth in Advanced APM 
participation. The additional QPs would be excluded from MIPS and 
likely not report. Second, we anticipate that some portion of the 
clinicians that opted to participate in PQRS may elect to not 
participate in MIPS, and, therefore, the actual number of participants 
may be lower than our estimates. However, we believe our estimates are 
the most appropriate given the available data.
    Framework for Understanding the Burden of MIPS Data Submission: 
Because of the wide range of information collection requirements under 
MIPS, Table 62 presents a framework for understanding how the 
organizations permitted or required to submit data on behalf of 
clinicians varies across the types of data, and whether the clinician 
is a MIPS eligible clinician, MIPS APM participant, or an Advanced APM 
participant. As shown in the first row of Table 62, MIPS eligible 
clinicians that are not in MIPS APMs and other clinicians voluntarily 
submitting data will submit data either as individuals, groups, or 
virtual groups for the quality, Promoting Interoperability, and 
improvement activities performance categories. Note that virtual groups 
are subject to the same requirements as groups, therefore we will refer 
only to groups for the remainder of this section unless otherwise 
noted. Because MIPS eligible clinicians are not required to provide any 
additional information for assessment under the cost performance 
category, the administrative claims data used for the cost performance 
category is not represented in Table 62.
    For MIPS eligible clinicians participating in MIPS APMs, the 
organizations submitting data on behalf of MIPS eligible clinicians 
will vary between performance categories and, in some instances, 
between MIPS APMs. For the 2019 MIPS performance period, the quality 
data submitted by Shared Savings Program ACOs, Next Generation ACOs, 
and other APM Entities on behalf of their participant MIPS eligible 
clinicians will fulfill any MIPS submission requirements for the 
quality performance category.
    For the Promoting Interoperability performance category, group TINs 
may submit data on behalf of eligible clinicians in MIPS APMs, or 
eligible clinicians in MIPS APMs may submit Promoting Interoperability 
performance category data individually. For the improvement activities 
performance category, we will assume no reporting burden for MIPS APM 
participants. In the CY 2017 Quality Payment Program final rule, we 
describe that for MIPS APMs, we compare the requirements of the 
specific MIPS APM with the list of activities in the Improvement 
Activities Inventory and score those activities in the same manner that 
they are otherwise scored for MIPS eligible clinicians (81 FR 77185). 
Although the policy allows for the submission of additional improvement 
activities if a MIPS APM receives less than the maximum improvement 
activities performance category score, to date all MIPS APM have 
qualified for the maximum improvement activities score. Therefore, we 
assume that no additional submission will be needed.
    Advanced APM participants who are determined to be Partial QPs may 
incur additional burden if they elect to participate in MIPS, which is 
discussed in more detail in the CY 2018 Quality Payment Program final 
rule (82 FR 53841 through 53844), but other than the election to 
participate in MIPS, we do not have data to estimate that burden.

[[Page 36015]]



Table 62--Clinicians or Organizations Submitting MIPS Data on Behalf of Clinicians, by Type of Data and Category
                                                 of Clinician *
----------------------------------------------------------------------------------------------------------------
                                                              Type of data submitted
                                --------------------------------------------------------------------------------
                                                                                                  Other data
     Category of clinician             Quality            Promoting           Improvement        submitted on
                                     performance       interoperability       activities        behalf of MIPS
                                      category           performance          performance          eligible
                                                           category            category           clinicians
----------------------------------------------------------------------------------------------------------------
MIPS Eligible Clinicians (not    As group or         As group or          As group or         Groups electing to
 in MIPS APMs) and Other          individual          individual           individual          use a CMS-
 Eligible Clinicians              clinicians.         clinicians.          clinicians.         approved survey
 Voluntarily Submitting Data                          Clinicians who are                       vendor to
 \a\.                                                 hospital-based,                          administer CAHPS
                                                      ambulatory                               must register.
                                                      surgical center-                         Groups electing
                                                      based, non-patient                       to submit via CMS
                                                      facing, physician                        Web Interface for
                                                      assistants, nurse                        the first time
                                                      practitioners,                           must register.
                                                      clinician nurse                          Virtual groups
                                                      specialists,                             must register via
                                                      certified                                email.
                                                      registered nurse
                                                      anesthetists,
                                                      physical
                                                      therapists,
                                                      occupational
                                                      therapists,
                                                      clinical social
                                                      workers, and
                                                      clinical
                                                      psychologists are
                                                      automatically
                                                      eligible for a
                                                      zero percent
                                                      weighting for the
                                                      Promoting
                                                      Interoperability
                                                      performance
                                                      category.
                                                      Clinicians
                                                      approved for
                                                      significant
                                                      hardship or other
                                                      exceptions are
                                                      also eligible for
                                                      a zero percent
                                                      weighting.
Eligible Clinicians              ACOs submit to the  Each MIPS eligible   CMS will assign     Advanced APM
 participating in the Shared      CMS Web Interface   clinician in the     the improvement     Entities will
 Savings Program or Next          and CAHPS for       APM Entity reports   activities          make election for
 Generation ACO Model (both       ACOs on behalf of   data for the         performance         participating
 MIPS APMs).                      their               Promoting            category score to   MIPS eligible
                                  participating       Interoperability     each APM Entity     clinicians.
                                  MIPS eligible       performance          group based on
                                  clinicians.         category through     the activities
                                  [These              either group TIN     involved in
                                  submissions are     or individual        participation in
                                  not included in     reporting. [Burden   the Shared
                                  burden estimates    estimates for this   Savings
                                  for this proposed   proposed rule        Program.\d\ [The
                                  rule because        assume group TIN-    burden estimates
                                  quality data        level reporting.]    for this proposed
                                  submission to       \c\                  rule assume no
                                  fulfill                                  improvement
                                  requirements of                          activity
                                  the Shared                               reporting burden
                                  Savings Program                          for APM
                                  and for purposes                         participants
                                  of testing and                           because we assume
                                  evaluating the                           the MIPS APM
                                  Next Generation                          model provides a
                                  ACO Model are not                        maximum
                                  subject to the                           improvement
                                  PRA.] \b\                                activity
                                                                           performance
                                                                           category score.]
Eligible Clinicians              APM Entities        Each MIPS eligible   CMS will assign     Advanced APM
 participating in Other MIPS      submit to MIPS on   clinician in the     the same            Entities will
 APMs.                            behalf of their     APM Entity reports   improvement         make election for
                                  participating       data for the         activities          participating
                                  MIPS eligible       Promoting            performance         eligible
                                  clinicians.         Interoperability     category score to   clinicians.
                                  [These              performance          each APM Entity
                                  submissions are     category through     based on the
                                  not included in     either group TIN     activities
                                  burden estimates    or individual        involved in
                                  for this proposed   reporting. [The      participation in
                                  rule because        burden estimates     the MIPS APM.
                                  quality data        for this proposed    [The burden
                                  submission for      rule assume group    estimates for
                                  purposes of         TIN-level            this proposed
                                  testing and         reporting.]          rule assume no
                                  evaluating                               improvement
                                  Innovation Center                        activities
                                  models tested                            performance
                                  under Section                            category
                                  1115A of the                             reporting burden
                                  Social Security                          for APM
                                  Act (or Section                          participants
                                  3021 of the                              because we assume
                                  Affordable Care                          the MIPS APM
                                  Act) are not                             model provides a
                                  subject to the                           maximum
                                  PRA.]                                    improvement
                                                                           activity score.]
----------------------------------------------------------------------------------------------------------------
* Because the cost performance category relies on administrative claims data, MIPS eligible clinicians are not
  required to provide any additional information, and therefore, the cost performance category is not
  represented in this table.
\a\ Virtual group participation is limited to MIPS eligible clinicians, specifically, solo practitioners and
  groups consisting of 10 eligible clinicians or fewer.

[[Page 36016]]

 
\b\ Sections 1899 and 1115A of the Act state the Shared Savings Program and testing, evaluation, and expansion
  of Innovation Center models are not subject to the PRA (42 U.S.C. 1395jjj and 42 U.S.C. 1315a, respectively).
\c\ Both group TIN and individual clinician Promoting Interoperability data will be accepted. If both group TIN
  and individual scores are submitted for the same APM Entity, CMS would take the higher score for each TIN/NPI.
  The TIN/NPI scores are then aggregated for the APM Entity score.
\d\ APM Entities participating in MIPS APMs do not need to submit improvement activities data unless the CMS-
  assigned improvement activities scores are below the maximum improvement activities score.

    The policies finalized in the CY 2017 and CY 2018 Quality Payment 
Program final rules and proposed in this CY 2019 rule create some 
additional data collection requirements not listed in Table 62. These 
additional data collections, some of which were previously approved by 
OMB under the control numbers 0938-1314 (Quality Payment Program) and 
0938-1222 (CAHPS for MIPS), are as follows:
    Additional approved ICRs related to MIPS third-party vendors
     Self-nomination of new and returning QCDRs (81 FR 77507 
through 77508 and 82 FR 53906 through 53908) (0938-1314).
     Self-nomination of new and returning registries (81 FR 
77507 through 77508 and 82 FR 53906 through 53908) (0938-1314).
     Approval process for new and returning CAHPS for MIPS 
survey vendors (82 FR 53908) (0938-1222).
    Additional ICRs related to the data submission and the quality 
performance category
     CAHPS for MIPS survey completion by beneficiaries (81 FR 
77509 and 82 FR 53916 through 53917) (0938-1222).
     Quality Payment Program Identity Management Application 
Process (82 FR 53914).
    Additional ICRs related to the Promoting Interoperability 
performance category
     Application for Promoting Interoperability Reweighting (82 
FR 53918) (0938-1314).
    Additional ICRs related to call for new MIPS measures and 
activities
     Nomination of improvement activities (82 FR 53922) (0938-
1314).
     Call for new Promoting Interoperability measures (0938-
1314).
     Call for new quality measures (0938-1314).
    Additional ICRs related to MIPS
     Opt out of performance data display on Physician Compare 
for voluntary reporters under MIPS (82 FR 53924 through 53925) (0938-
1314).
    Additional ICRs related to APMs
     Partial QP Election (81 FR 77512 through 77513 and 82 FR 
53922 through 53923) (0938-1314).
     Other Payer Advanced APM determinations: Payer Initiated 
Process (82 FR 53923 through 53924) (0938-1314).
     Other Payer Advanced APM determinations: Eligible 
Clinician Initiated Process (82 FR 53924) (0938-1314).
     Submission of Data for All-Payer QP Determinations (New 
data collection for the 2019 performance period).
6. Quality Payment Program ICRs Regarding the Virtual Group Election 
(Sec.  414.1315)
    This rule does not propose any new or revised reporting, 
recordkeeping, or third-party disclosure requirements related to the 
virtual group election. The virtual group election requirements and 
burden are currently approved by OMB under control number 0938-1343 
(CMS-10652). Consequently, we are not making any virtual group election 
changes under that control number.
7. Quality Payment Program ICRs Regarding Third-Party Reporting (Sec.  
414.1400)
    Under MIPS, quality, Promoting Interoperability, and improvement 
activities performance category data may be submitted via relevant 
third-party intermediaries, such as qualified registries, QCDRs, and 
health IT vendors. Data on the CAHPS for MIPS survey, which counts as 
one quality performance category measure, can be submitted via CMS-
approved survey vendors. In the CY 2018 Quality Payment Program final 
rule, we combined the burden for self-nomination of qualified 
registries and QCDRs (82 FR 53906). For this proposed rule, we 
determined that requirements for self-nomination for qualified 
registries were sufficiently different from QCDRs that it is necessary 
to estimate the two independently. The change would align the burden 
more closely to the requirements for QCDRs and qualified registries to 
self-nominate, not because of any change in policy in this proposed 
rule. Specifically, while the processes for self-nomination are 
similar, QCDRs have the option to submit QCDR measures for the quality 
performance category. Therefore, differences between QCDRs and 
registries self-nomination are associated with the preparation of QCDR 
measures for approval. The burden associated with qualified registry 
self-nomination, QCDR self-nomination, and the CAHPS for MIPS survey 
vendor applications follow:
    Qualified Registry Self-Nomination: The proposed requirements and 
burden associated with qualified registry self-nomination will be 
submitted to OMB for approval under control number 0938-1314 (CMS-
10621).
    Qualified registries interested in submitting MIPS data to us on 
their participants' behalf need to complete a self-nomination process 
to be considered qualified to submit on behalf of MIPS eligible 
clinicians or groups (82 FR 53815).
    In the CY 2018 Quality Payment Program final rule, previously 
approved qualified registries in good standing (that are not on 
probation or disqualified) that wish to self-nominate using the 
simplified process can attest, in whole or in part, that their 
previously approved form is still accurate and applicable (82 FR 
53815). In the same rule, qualified registries in good standing that 
would like to make minimal changes to their previously approved self-
nomination application from the previous year, may submit these 
changes, and attest to no other changes from their previously approved 
qualified registry application, for CMS review during the self-
nomination period, from September 1 to November 1 (82 FR 53815). This 
simplified self-nomination process will begin for the 2019 MIPS 
performance period.
    The CY 2017 Quality Payment Program final rule provided the 
definition of a qualified registry to be a medical registry, a 
maintenance of certification program operated by a specialty body of 
the American Board of Medical Specialties or other data intermediary 
that, with respect to a particular performance period, has self-
nominated and successfully completed a vetting process (as specified by 
CMS) to demonstrate its compliance with the MIPS qualification criteria 
specified by CMS for that performance period (81 FR 77382).
    For this CY 2019 Quality Payment Program rule, we are proposing 
adjustments to the number of respondents (from 120 to 150) based on 
more recent data and a revised definition of ``respondent'' to account 
for self-nomination applications received but not approved. We are also 
proposing adjustments to our per respondent time estimate (from 10 
hours to 3 hours) based on our review of the current burden estimates 
against the existing policy. Additionally, we are proposing a range of 
time estimates

[[Page 36017]]

(from 10 hours to 0.5 hours) which reflect the availability of a 
simplified self-nomination process for previously approved qualified 
registries.
    For the 2017 MIPS performance period, we received 138 applications 
for nomination to be a qualified registry and 145 applications for the 
2018 MIPS performance period. In continuance of this trend for the 2019 
MIPS performance period, we estimate 150 nomination applications will 
be received from qualified registries desiring approval to report MIPS 
data, an increase of 30 respondents.
    For this proposed rule, the burden associated with qualified 
registry self-nomination will vary depending on the number of existing 
qualified registries that will elect to use the simplified self-
nomination process in lieu of the full self-nomination process as 
described in the CY 2018 Quality Payment Program final rule (82 FR 
53815). The self-nomination form is submitted electronically using the 
web-based tool JIRA. For the CY 2018 performance period, 141 qualified 
registries were approved to submit MIPS data.
    In the CY 2018 Quality Payment Program final rule, we estimated the 
burden associated with self-nomination of a qualified registry to be 10 
hours, similar to PQRS (82 FR 53907). For this proposed rule, we reduce 
our estimate to 3 hours because registries no longer provide an XML 
submission, calculated measure, or measure flow as part of the self-
nomination process and are not subject to a mandatory interview, which 
were done previously as part of the PQRS qualified registry self-
nomination process, upon which the previous assumption of 10 hours was 
based. As described in the CY 2017 Quality Payment Program final rule, 
the full self-nomination process requires the submission of basic 
information, a description of the process the qualified registry will 
use for completion of a randomized audit of a subset of data prior to 
submission, and the provision of a data validation plan along with the 
results of the executed data validation plan by May 31 of the year 
following the performance period (81 FR 77383 through 77384).
    For the simplified self-nomination process, we estimate 0.5 hours 
per qualified registry to submit a nomination, a reduction of 9.5 hours 
from currently approved estimates.
    As shown in Table 63, we estimate that the staff involved in the 
qualified registry self-nomination process will be mainly computer 
systems analysts or their equivalent, who have an adjusted labor cost 
of $89.18/hour. Assuming that the time associated with the self-
nomination process ranges from a minimum of 0.5 hours (for the 
simplified self-nomination process) to 3 hours (for the full self-
nomination process) per qualified registry, we estimate that the annual 
burden will range from 97.5 hours ([141 qualified registries x 0.5 hr] 
+ [9 qualified registries x 3 hr]) to 450 hours (150 qualified 
registries x 3 hr) at a cost ranging from $8,695 (97.5 hr x $89.18/hr) 
to $40,131 (450 hr x $89.18/hr), respectively (see Table 63).
    Independent of the change to our per response time estimate, the 
increase in the number of respondents results in an adjustment of 300 
hours and $26,754 (30 registries x 10 hr x $89.18/hr). Accounting for 
the change in the number of qualified registries, the change in time 
per qualified registry to self-nominate results in an adjustment of 
between -1,402.5 hours and -125,075 ([(141 registries x-9.5 hr)] + [(9 
registries x-7 hr)] at $89.18/hr) and -1,050 hours and -$93,639 (150 
registries x-7 hr x $89.18/hr). When these two adjustments are 
combined, the net impact ranges between -1,102.5 (-1,402.5 + 300) and -
750 (-1,050 + 300) hours and -$98,321 (-$125,075 + $26,754) and -
$66,885 (-$93,639 + $26,754).
    Qualified registries must comply with requirements on the 
submission of MIPS data to CMS. The burden associated with the 
qualified registry submission requirements will be the time and effort 
associated with calculating quality measure results from the data 
submitted to the qualified registry by its participants and submitting 
these results, the numerator and denominator data on quality measures, 
the Promoting Interoperability performance category, and improvement 
activities data to us on behalf of their participants. These 
requirements are currently approved by OMB under control number 0938-
1314 (CMS-10621) with no changes being proposed.
    We expect that the time needed for a qualified registry to 
accomplish these tasks will vary along with the number of MIPS eligible 
clinicians submitting data to the qualified registry and the number of 
applicable measures. However, we believe that qualified registries 
already perform many of these activities for their participants. We 
believe the estimates discussed above and shown in Table 63 represents 
the upper bound of registry burden, with the potential for less 
additional MIPS burden if the registry already provides similar data 
submission services.
    Based on the assumptions previously discussed, we provide an 
estimate of the total annual burden associated with a qualified 
registry self-nominating to be considered ``qualified'' to submit 
quality measures results and numerator and denominator data on MIPS 
eligible clinicians.

    Table 63--Estimated Burden for Qualified Registry Self-Nomination
------------------------------------------------------------------------
                                          Minimum burden  Maximum burden
------------------------------------------------------------------------
Number of Qualified Registry Simplified              141               0
 Self-Nomination Applications submitted
 (a)....................................
Number of Qualified Registry Full Self-                9             150
 Nomination Applications submitted (b)..
Total Annual Hours Per Qualified                     0.5             0.5
 Registry for Simplified Process (c)....
Total Annual Hours Per Qualified                       3               3
 Registry for Full Process (d)..........
                                         -------------------------------
    Total Annual Hours for Qualified                97.5             450
     Registries (e) = (a) * (c) + (b) *
     (d)................................
------------------------------------------------------------------------
Cost Per Simplified Process Per Registry          $44.59          $44.59
 (@computer systems analyst's labor rate
 of $89.18/hr.) (f).....................
Cost Per Full Process Per Registry               $267.54         $267.54
 (@computer systems analyst's labor rate
 of $89.18/hr.) (g).....................
                                         -------------------------------
    Total Annual Cost for Qualified               $8,695         $40,131
     Registries (h) = (a) * (f) + (b) *
     (g)................................
------------------------------------------------------------------------

    Both the minimum and maximum burden shown in Table 64 will be 
submitted for approval to OMB under control number 0938-1314 (CMS-
10621) and reflect adjustments due to review of self-nomination process 
and the number of respondents. For purposes of calculating total burden 
associated with the proposed rule as

[[Page 36018]]

shown in Table 89, only the maximum burden will be used.
    QCDR Self-Nomination: \42\ The proposed requirements and burden 
associated with QCDR self-nomination will be submitted to OMB for 
approval under control number 0938-1314 (CMS-10621).
---------------------------------------------------------------------------

    \42\ We do not anticipate any changes in the CEHRT process for 
health IT vendors as we transition to MIPS. Hence, health IT vendors 
are not included in the burden estimates for MIPS.
---------------------------------------------------------------------------

    QCDRs interested in submitting quality, Promoting Interoperability, 
and improvement activities performance category data to us on their 
participants' behalf will need to complete a self-nomination process to 
be considered qualified to submit on behalf of MIPS eligible clinicians 
or groups.
    In the CY 2018 Quality Payment Program final rule, previously 
approved QCDRs in good standing (that are not on probation or 
disqualified) that wish to self-nominate using the simplified process 
can attest, in whole or in part, that their previously approved form is 
still accurate and applicable (82 FR 53808). Existing QCDRs in good 
standing that would like to make minimal changes to their previously 
approved self-nomination application from the previous year, may submit 
these changes, and attest to no other changes from their previously 
approved QCDR application, for CMS review during the self-nomination 
period, from September 1 to November 1 (82 FR 53808). This simplified 
self-nomination process will begin for the 2019 MIPS performance 
period.
    For this proposed rule, the burden associated with QCDR self-
nomination will vary depending on the number of existing QCDRs that 
will elect to use the simplified self-nomination process in lieu of the 
full self-nomination process as described in the CY 2018 Quality 
Payment Program final rule (82 FR 53808 through 53813). The self-
nomination form is submitted electronically using the web-based tool 
JIRA. For the CY 2018 performance period, 150 QCDRs were approved to 
submit MIPS data.
    For this CY 2019 Quality Payment Program rule, we are proposing 
adjustments to the number of respondents (from 113 to 200) based on 
more recent data and a revised definition of ``respondent'' to account 
for self-nomination applications received but not approved. We are also 
proposing adjustments to the time burden estimates per respondent based 
on our review of the current burden estimates against the existing 
policy as well as proposing a range of time burden estimates which 
reflect the availability of a simplified self-nomination process for 
previously approved QCDRs.
    For the 2017 MIPS performance period, we received 138 self-
nomination applications from QCDRs and for the 2018 MIPS performance 
period, we received 176 self-nomination applications. In continuance of 
this trend for the 2019 MIPS performance period, we estimate 200 self-
nomination applications will be received from QCDRs desiring approval 
to report MIPS data, an increase of 87 respondents.
    We estimate that the self-nomination process for QCDRs to submit on 
behalf of MIPS eligible clinicians or groups for MIPS will involve 
approximately 3 hours per QCDR to submit information required at the 
time of self-nomination as described in the CY 2017 Quality Payment 
Program final rule including basic information about the QCDR, describe 
the process it will use for completion of a randomized audit of a 
subset of data prior to submission, provide a data validation plan, and 
provide results of the executed data validation plan by May 31 of the 
year following the performance period (81 FR 77383 through 77384). 
However, for the simplified self-nomination process, we estimate 0.5 
hours per QCDR to submit this information. The self-nomination form is 
submitted electronically using the web-based tool JIRA.
    In addition, QCDRs calculate their measure results. QCDRs must 
possess benchmarking capabilities (for QCDR measures) that compare the 
quality of care a MIPS eligible clinician provides with other MIPS 
eligible clinicians performing the same quality measures. For QCDR 
measures, the QCDR must provide to us, if available, data from years 
prior (for example, 2017 data for the 2019 MIPS performance period) 
before the start of the performance period. In addition, the QCDR must 
provide to us, if available, the entire distribution of the measure's 
performance broken down by deciles. As an alternative to supplying this 
information to us, the QCDR may post this information on their website 
prior to the start of the performance period, to the extent permitted 
by applicable privacy laws. The time it takes to perform these 
functions may vary depending on the sophistication of the entity, but 
we estimate that a QCDR will spend an additional 1 hour performing 
these activities per measure and assume that each QCDR will submit 
information for 9 QCDR measures, for a total burden of 9 hours per QCDR 
(1 hr per measure x 9 measures). The estimated average of 9 measures 
per QCDR is based on the number of QCDR measure submissions received in 
the 2017 and 2018 MIPS performance periods and is the same for each 
QCDR regardless of whether they elect to use the simplified or full 
self-nomination process.
    In the 2017 MIPS performance period, we received over 1,000 QCDR 
measure submissions. In the 2018 MIPS performance period, we received 
over 1,400 QCDR measure submissions. For the 2019 MIPS performance 
period, we anticipate this trend will continue, and therefore, estimate 
we will receive a total of approximately 1,800 QCDR measure 
submissions, resulting in an average of 9 measure submissions per QCDR 
(1,800 measure submissions/200 QCDRs).
    In the CY 2018 Quality Payment Program final rule, the burden 
associated with self-nomination of a QCDR was estimated to be 10 hours 
(82 FR 53907). For this proposed rule, we are increasing the burden 
associated with self-nomination to 12 hours because QCDRs are no longer 
required provide an XML submission and are not subject to a mandatory 
interview; both of which were completed as part of the PQRS QCDR self-
nomination process upon which the previous assumption of 10 hours was 
based, while simultaneously accounting for an increase in the number of 
QCDR measure submissions being submitted.
    As shown in Table 64, we estimate that the staff involved in the 
QCDR self-nomination process will continue to be computer systems 
analysts or their equivalent, who have an average labor cost of $89.18/
hr. Assuming that the hours per QCDR associated with the self-
nomination process ranges from a minimum of 9.5 hours (for the 
simplified self-nomination process) to 12 hours (for the full self-
nomination process), we estimate that the annual burden will range from 
2,025 hours ([150 QCDRs x 9.5 hr] + [50 QCDRs x 12 hr]) to 2,400 hours 
(200 QCDRs x 12 hr) at a cost ranging between $180,590 (2,025 hr x 
$89.18/hr) and $214,032 (2,400 hr x $89.18/hr), respectively (see Table 
64).
    Independent of the change to our per response time estimate, the 
increase in the number of respondents results in an adjustment of 870 
hours and $77,587 (87 registries x 10 hr x $89.18/hr). Accounting for 
the change in the number of qualified registries, the change in time 
per QCDR to self-nominate results in an adjustment of between 25 hours 
and $2,230 ([150 registries x-0.5 hr] + [50 registries x 2 hr] at 
$89.18/hr) and 400 hours and $35,672 (200 registries x 2 hr x $89.18/

[[Page 36019]]

hr). When these two adjustments are combined, the net impact ranges 
between 895 (870 + 25) hours at $79,817 ($77,587 + $2,230) and 1,270 
(870 + 400) hours at $113,259 ($77,587 + $35,672).
    QCDRs must comply with requirements on the submission of MIPS data 
to CMS. The burden associated with the QCDR submission requirements 
will be the time and effort associated with calculating quality measure 
results from the data submitted to the QCDR by its participants and 
submitting these results, the numerator and denominator data on quality 
measures, the Promoting Interoperability performance category, and 
improvement activities data to us on behalf of their participants. 
These requirements are currently approved by OMB under control number 
0938-1314 (CMS-10621) with no changes being proposed. We expect that 
the time needed for a QCDR to accomplish these tasks will vary along 
with the number of MIPS eligible clinicians submitting data to the QCDR 
and the number of applicable measures. However, we believe that QCDRs 
already perform many of these activities for their participants. We 
believe the estimate noted in this section represents the upper bound 
of QCDR burden, with the potential for less additional MIPS burden if 
the QCDR already provides similar data submission services.
    Based on the assumptions previously discussed, we provide an 
estimate of the total annual burden associated with a QCDR self-
nominating to be considered ``qualified'' to submit quality measures 
results and numerator and denominator data on MIPS eligible clinicians.

           Table 64--Estimated Burden for QCDR Self-Nomination
------------------------------------------------------------------------
                                          Minimum burden  Maximum burden
------------------------------------------------------------------------
Number of QCDR Simplified Self-                      150               0
 Nomination Applications submitted (a)..
Number of QCDR Full Self-Nomination                   50             200
 Applications submitted (b).............
Total Annual Hours Per QCDR for                      9.5             9.5
 Simplified Process (c).................
Total Annual Hours Per QCDR for Full                  12              12
 Process (d)............................
                                         -------------------------------
    Total Annual Hours for QCDRs (e) =             2,025           2,400
     (a) * (c) + (b) * (d)..............
------------------------------------------------------------------------
Cost Per Simplified Process Per QCDR             $847.21         $847.21
 (@computer systems analyst's labor rate
 of $89.18/hr.) (f).....................
Cost Per Full Process Per QCDR                 $1,070.16       $1,070.16
 (@computer systems analyst's labor rate
 of $89.18/hr.) (g).....................
                                         -------------------------------
    Total Annual Cost for QCDRs (h) =           $180,590        $214,032
     (a) * (f) + (b) * (g)..............
------------------------------------------------------------------------

    Both the minimum and maximum burden shown in Table 64 will be 
submitted for approval to OMB under control number 0938-1314 (CMS-
10621) and reflect adjustments due to review of self-nomination process 
and the number of respondents. For purposes of calculating total burden 
associated with the proposed rule as shown in Table 89, only the 
maximum burden will be used.
    CMS-Approved CAHPS for MIPS Survey Vendors: This rule does not 
propose any new or revised reporting, recordkeeping, or third-party 
disclosure requirements related to CMS-approved CAHPS for MIPS survey 
vendors. The CMS-approved CAHPS for MIPS survey vendor requirements and 
burden are currently approved by OMB under control number 0938-1222 
(CMS-10450). Consequently, we are not making any MIPS survey vendor 
changes under that control number.
8. Quality Payment Program ICRs Regarding Data Submission (Sec. Sec.  
414.1325 and 414.1335)
    Under our current policies, two groups of clinicians will submit 
quality data under MIPS: Those who submit as MIPS eligible clinicians 
and other eligible clinicians who opt to submit data voluntarily but 
will not be subject to MIPS payment adjustments. While the proposed 
expansion of the definition of a MIPS eligible clinician to new 
clinician types and the opt-in process for MIPS participation discussed 
in sections III.H.3.a and III.H.3.c.(6) of this proposed rule could 
affect respondent counts, all of the new potential respondents had the 
opportunity to participate in PQRS. Therefore, consistent with our 
assumptions in the CY 2017 and CY 2018 Quality Payment Program final 
rules that PQRS participants that are not QPs would have participated 
in MIPS as voluntary respondents (81 FR 77501 and 82 FR 53908, 
respectively), we anticipate that this rule's proposed expansion of the 
definition of a MIPS eligible clinician will not have any incremental 
effect on any of our currently approved burden estimates. Our 
respondent assumptions regarding QPs have been updated using the APM 
Participation List for the third snapshot date of the 2017 QP 
performance period in place of the 2017 QP determination data used to 
estimate respondents in the CY 2018 Quality Payment Program final rule 
(82 FR 53908). With this exception, our respondent assumptions remain 
the same as approved in the approved PRA.
    For the purpose of the following analyses, we assume that a total 
of 763,383 clinicians who participated in PQRS for the reporting 
periods occurring in 2016 and who are not QPs in Advanced APMs in the 
2017 MIPS performance period will continue to submit quality data in 
the 2019 MIPS performance period. This number differs from the 
currently approved estimate (OMB 0938-1314, CMS-10621) of 134,802 due 
to more QPs being identified and removed. We assume that 100 percent of 
APM Entities in MIPS APMs will submit quality data to CMS as required 
under their models.\43\
---------------------------------------------------------------------------

    \43\ We estimate that 120,508 clinicians that participated in 
the 2016 PQRS will be QPs who will not be not required to submit 
MIPS quality performance category data under MIPS, and are not 
included in the numerator or denominator of our participation rate. 
This is a difference of 19,859 compared to the number of QPs in the 
CY 2018 Quality Payment Program final rule (82 FR 53908).
---------------------------------------------------------------------------

    As discussed in section III.H.3.h.(1).(b) of this proposed rule, we 
are proposing to replace the term ``submission mechanism'' with the 
terms ``collection type'' and ``submission type.'' ``Submission 
mechanism'' is presently used to refer not only to the mechanism by 
which data is submitted, but also to certain types of measures and 
activities on which data are submitted to the entities submitting such 
data in the Quality Payment Program.
    Apart from clinicians that became QPs in the 2017 MIPS performance 
period, we assume that clinicians will continue to submit quality data 
for the same collection types they used under the 2016 PQRS. As 
discussed in the CY

[[Page 36020]]

2018 Quality Payment Program final rule (82 FR 53905), when describing 
the burden for the virtual group application process, we assume that 
the 80 TINs that elect to form 16 virtual groups will continue to 
collect and submit MIPS data using the same collection and submission 
types as they did when reporting under the 2016 PQRS, but the 
submission will be at the virtual group, rather than group level. Our 
burden estimates for the quality performance category do not include 
the burden for the quality data that APM Entities submit to fulfill the 
requirements of their models. The burden is excluded as sections 3021 
and 3022 of the Affordable Care Act state the Shared Savings Program 
and the testing, evaluation, and expansion of Innovation Center models 
tested under section 1115A of the Act (or section 3021 of the 
Affordable Care Act) are not subject to the PRA (42 U.S.C. 1395jjj(e) 
and 1315a(d)(3), respectively).\44\ Tables 65, 66, and 67 explain our 
revised estimates of the number of organizations (including groups, 
virtual groups, and individual MIPS eligible clinicians) submitting 
data on behalf of clinicians segregated by collection type.
---------------------------------------------------------------------------

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

    Table 65 provides our estimated counts of clinicians that will 
submit quality performance category data as MIPS individual clinicians 
or groups in the 2019 MIPS performance period. First, we estimated the 
number of clinicians that submit data as an individual clinician or 
group during the 2019 MIPS performance period using 2016 PQRS data on 
individuals and groups by collection type and excluded clinicians 
identified as QPs using the APM Participation List for the third 
snapshot date of the 2017 QP performance period.
    For the 2019 performance period, respondents will have the option 
to submit quality performance category data via claims, direct, log in 
and upload, and CMS Web Interface submission types. For this proposed 
rule, participation data by submission type and user research data to 
inform burden assumptions are not available to estimate burden by 
submission type. As a result, we continue to estimate the burden for 
collecting data via collection type: Claims, QCDR and MIPS CQMs, eCQMs, 
and the CMS Web Interface. As we gain more experience with the program, 
we may revise this approach in the future.
    For the claims collection type, in section III.H.3.h.(1).(b) of 
this rule, we propose to limit the Medicare Part B claims collection 
type to small practices beginning with the 2021 MIPS payment year and 
to allow clinicians in small practices to report claims as a group. We 
assume in our currently approved burden analysis that any clinician 
that submits quality data codes to us for the claims collection type is 
intending to do so for the Quality Payment Program. We made this 
assumption originally in the CY 2016 Quality Payment Program final rule 
to ensure that we fully accounted for any burden that may have resulted 
from our policies. In some cases, however, clinicians may be submitting 
quality data codes not only for claims collection type, but also for 
MIPS CQM and QCDR collection types. Some registries and QCDRs utilize 
data from claims to populate their datasets when submitting on behalf 
of clinicians. We are not able to separate out when a clinician submits 
a quality data code solely for the claim collection type or when a 
clinician is also submitting these codes for MIPS CQM or QCDR 
collection types. In addition, we see a large number of voluntary 
reporters for the claims collection type. Approximately half of the 
274,702 clinicians we estimate will submit quality data via claims (see 
Table 65) are MIPS eligible clinicians while the other half are 
voluntary reporters which means our burden include estimates for a 
large number of voluntary reporters. Approximately 60 percent of these 
274,702 clinicians are in practices with more than 15 clinicians; 
however, over 80 percent of the number in practices larger than 15 
clinicians are either voluntary reporters, group reporters, or are also 
reporting quality data through another collection type. Approximately 
25,000 clinicians in non-small practices are both MIPS eligible and 
scored based only on claims data. Overall, we find that approximately 
47 percent of the clinicians reporting claims in non-small practices 
would also qualify for facility-based reporting, and therefore, would 
not be required to submit quality data. It is unclear why many 
clinicians are submitting quality data via an alternate collection type 
and we currently lack data to estimate both the number of clinicians 
who would be impacted by this proposal and the potential behavioral 
response of those clinicians who would be required to switch to another 
collection type. As a result, we propose to continue using the 
assumption that all clinicians (except QPs) who submitted data to 2016 
PQRS via the claims collection type would continue to do so for MIPS in 
order to avoid overstating the impact of the proposed change. We intend 
to update this burden estimate with additional data as it becomes 
available. We also seek comment on potential other assumptions for 
capturing the claims burden.
    Due to data limitations, our burden estimates for all quality 
collection types continue to assume that clinicians who submitted data 
in PQRS (except QPs) would continue to do so using the same collection 
types in MIPS. Using our proposed terminology, clinicians who used a 
QCDR or Registry would now collect measures via QCDR or MIPS CQM 
collection type; clinicians who used the EHR in PQRS would elect the 
eCQM collection type, and groups that elected the CMS Web Interface for 
PQRS would elect the CMS Web Interface for MIPS.
    In addition, participation data for the 2017 MIPS performance 
period was unavailable in time for this proposed rule, with the 
exception of CMS Web Interface respondents. If actual participation 
data for the 2017 MIPS performance period is available in time to meet 
our final rule's publication schedule, we will use this data and revise 
our estimates in that rule. Based on these methods, Table 65 shows that 
in the 2019 MIPS performance period, an estimated 274,702 clinicians 
will submit data as individuals for the claims collection type; 267,736 
clinicians will submit data as individuals or as part of groups for the 
MIPS CQM or QCDR collection types; 129,188 clinicians will submit data 
as individuals or as part of groups via eCQM collection types; and 
91,757 clinicians will submit as part of groups via the CMS Web 
Interface.
    Table 65 provides estimates of the number of clinicians to collect 
quality measures data via each collection type, regardless of whether 
they decide to submit as individual clinicians or as part of groups. 
Because our burden estimates for quality data submission assume that 
burden is reduced when clinicians elect to submit as part of a group, 
we also separately estimate the expected number of clinicians to submit 
as individuals or part of groups.

[[Page 36021]]



    Table 65--Estimated Number of Clinicians Submitting Quality Performance Category Data by Collection Type
----------------------------------------------------------------------------------------------------------------
                                                                                      CMS web
                                      Claims       QCDR/MIPS CQM       eCQM          interface         Total
----------------------------------------------------------------------------------------------------------------
Number of clinicians to collect          274,702         267,736         129,188          91,757         763,383
 data by collection type (as
 individual clinicians or
 groups) in Quality Payment
 Program Year 3 (excludes QPs)
 (a)............................
* Number of clinicians to                278,039         255,228         131,133          93,867         758,267
 collect data by collection type
 (as individual clinicians or
 groups) in Quality Payment
 Program Year 2 (excludes QPs)
 (b)............................
Difference between Year 3 and             -3,337         +12,508          -1,945          -2,110          +5,116
 Year 2 (c) = (a)-(b)...........
----------------------------------------------------------------------------------------------------------------
* Currently approved by OMB under control number 0938-1314 (CMS-10621).

    In the CY 2018 Quality Payment Program final rule (82 FR 53625 
through 53626), beginning with the 2019 MIPS performance period, we 
allow MIPS eligible clinicians to submit data for multiple collection 
types for a single performance category. Therefore, we are capturing 
the burden of any eligible clinician that may have historically 
collected to PQRS via multiple collection types, as we assume they 
would continue to collect via multiple collection types and that our 
MIPS scoring methodology will take the highest score. Hence, the 
estimated numbers of individual clinicians and groups to collect via 
the various collection types are not mutually exclusive, and reflect 
the occurrence of individual clinicians or groups that collected data 
via multiple collection types under the 2016 PQRS.
    Table 66 uses methods similar to those described for Table 65 to 
estimate the number of clinicians to submit data as individual 
clinicians via each collection type in Quality Payment Program Year 3. 
We estimate that approximately 274,702 clinicians will submit data as 
individuals using the claims collection type; approximately 103,268 
clinicians will submit data as individuals using MIPS CQMs or QCDR 
collection types; and approximately 52,028 clinicians will submit data 
as individuals using eCQMs collection type.

     Table 66--Estimated Number of Clinicians Submitting Quality Performance Category Data as Individuals by
                                                 Collection Type
----------------------------------------------------------------------------------------------------------------
                                                                                      CMS web
                                      Claims       QCDR/MIPS CQM       eCQM          interface         Total
----------------------------------------------------------------------------------------------------------------
Number of Clinicians to submit           274,702         103,268          52,028               0         429,998
 data as individuals in Quality
 Payment Program Year 3
 (excludes QPs) (a).............
* Number of Clinicians to submit         278,039         104,281          52,709               0         435,029
 data as individuals in Quality
 Payment Program Year 2
 (excludes QPs) (b).............
Difference between Year 3 and             -3,337          -1,013            -681               0          -5,031
 Year 2 (c) = (a)-(b)...........
----------------------------------------------------------------------------------------------------------------
* Currently approved by OMB under control number 0938-1314 (CMS-10621).

    To be consistent with the policy in the CY 2018 Quality Payment 
Program final rule that for MIPS eligible clinicians who collect 
measures via claims, MIPS CQM, eCQM, or QCDR collection types and 
submit more than the required number of measures (82 FR 53735 through 
54736), we will score the clinician on the required measures with the 
highest assigned measure achievement points, our columns in Table 66 
are not mutually exclusive.
    Table 67 provides our estimated counts of groups or virtual groups 
to submit quality data on behalf of clinicians for each collection type 
in the 2019 MIPS performance period and reflects our assumption that 
the formation of virtual groups will reduce burden. Except for groups 
comprised entirely of QPs, we assume that groups that submitted quality 
data as groups under the 2016 PQRS will continue to submit quality data 
either as groups or virtual groups for the same collection types as 
they did as a group or TIN within a virtual group for the 2019 MIPS 
performance period. The first step was to estimate the number of groups 
or virtual groups to collect data via each collection type during the 
2019 MIPS performance period using 2016 PQRS data on groups collecting 
through various collection types and excluding clinicians identified as 
QPs using the APM Participation List for the third snapshot date of the 
2017 QP performance period. The second and third steps in Table 67 
reflect our currently approved assumption that virtual groups will 
reduce the burden for quality data submission by reducing the number of 
organizations to submit quality data on behalf of clinicians. We assume 
that 40 groups that previously collected on behalf of clinicians via 
QCDR or MIPS CQM collection types will elect to form 8 virtual groups 
that will collect via QCDR and MIPS CQM collection types. We assume 
that another 40 groups that previously collected on behalf of 
clinicians via eCQM collection types will elect to form another 8 
virtual groups that will collection via eCQM collection types. Hence, 
the second step in Table 67 is to subtract out the estimated number of 
groups under each collection type that will elect to form virtual 
groups, and the third step in Table 67 is to add in the estimated 
number of virtual groups that will submit on behalf of clinicians for 
each collection type.
    Specifically, we assumed that 3,788 groups and virtual groups will 
submit data for the QCDR or MIPS CQM collection types on behalf of 
164,468 clinicians; 1,501 groups and virtual groups will submit for 
eCQM collection types on behalf of 77,160 eligible clinicians; and 286 
groups will submit data via the CMS Web Interface on behalf of 91,757 
clinicians. Groups cannot elect to collect via claims collection type.

[[Page 36022]]



     Table 67--Estimated Number of Groups and Virtual Groups Submitting Quality Performance Category Data by
                                     Collection Type on Behalf of Clinicians
----------------------------------------------------------------------------------------------------------------
                                                                                      CMS web
                                      Claims       QCDR/MIPS CQM       eCQM          interface         Total
----------------------------------------------------------------------------------------------------------------
Number of groups to collect data               0           3,820           1,533             286           5,639
 by collection type (on behalf
 of clinicians) in Quality
 Payment Program Year 3
 (excludes QPs) (a).............
Subtract out: Number of groups                 0              40              40               0              80
 to collect data by collection
 type on behalf of clinicians in
 Quality Payment Program Year 3
 that will submit as virtual
 groups in Quality Payment
 Program Year 3 (b).............
Add in: Number of virtual groups               0               8               8               0              16
 to collect data by collection
 type on behalf of clinicians in
 Quality Payment Program Year 3
 (c)............................
Number of groups to collect data               0           3,788           1,501             286           5,575
 by collection type on behalf of
 clinicians in Quality Payment
 Program Year 3 (d) = (a)-(b) +
 (c)............................
* Number of groups to collect                  0           2,936           1,509             296           4,741
 data by collection type on
 behalf of clinicians in Quality
 Payment Program Year 2 (e).....
Difference between Year 3 and                  0             852              -8             -10             834
 Year 2 (f) = (d)-(e)...........
----------------------------------------------------------------------------------------------------------------
* Currently approved by OMB under control number 0938-1314 (CMS-10621).

    The burden estimates associated with submission of quality 
performance category data have some limitations. We believe it is 
difficult to quantify the burden accurately because clinicians and 
groups may have different processes for integrating quality data 
submission into their practices' work flows. Moreover, the time needed 
for a clinician to review quality measures and other information, 
select measures applicable to their patients and the services they 
furnish, and incorporate the use of quality data codes into the 
practice workflows is expected to vary along with the number of 
measures that are potentially applicable to a given clinician's 
practice and by the collection type. Further, these burden estimates 
are based on historical rates of participation in the PQRS program, and 
the rate of participation in MIPS is expected to differ. In addition, 
the submission type used to submit MIPS data may also vary from these 
estimates due to more accurate information being unavailable at this 
time for this proposed rule.
    We believe the burden associated with submitting quality measures 
data will vary depending on the collection type selected by the 
clinician, group, or third-party. As such, we separately estimate the 
burden for clinicians, groups, and third parties to submit quality 
measures data by the collection type used. For the purposes of our 
burden estimates for the claims, MIPS CQM and QCDR, and eCQM collection 
types, we also assume that, on average, each clinician or group will 
submit 6 quality measures.
    We estimate an increase in the number of QPs from 100,649 in CY 
2018 Quality Payment Program final rule to 120,508 for this proposed 
rule (82 FR 53908) and since they are excluded from submitting MIPS 
data, a decrease to our estimated number of respondents by submission 
and collection type relative to the estimates in the CY 2018 Quality 
Payment Program final rule (82 FR 53912 through 53915). As noted 
previously in this section, information collections associated with the 
Shared Savings Program and the testing, evaluation, and expansion of 
CMS Innovation Center models tested under section 1115A of the Act (or 
section 3021 of the Affordable Care Act) are not subject to the PRA.
    Quality Payment Program Identity Management Application Process: 
The proposed requirements and burden associated with the application 
process will be submitted to OMB for approval under control number 
0938-1314 (CMS-10621).
    In the CY 2018 Quality Payment Program final rule, the time 
associated with the Identity Management Application Process was 
described as ``Obtain Account in CMS-Specified Identity Management 
System'' and included in the ICR for Quality Data Submission by 
Clinicians and Groups: EHR Submission (82 FR 53914) for a total burden 
of 54,218 hours (1 hr x 54,218 respondents). After our review of the 
quality data submission process, we determined the burden associated 
with the application process (3,741 hours) should be accounted for in a 
separate ICR. Our per respondent burden estimate remains unchanged at 1 
hour per response.
    For an individual, group, or third-party to submit MIPS quality, 
improvement activities, or Promoting Interoperability performance 
category data using either the log in and upload or the log in and 
attest submission type or to access feedback reports, the submitter 
must have a CMS Enterprise Portal user account. Once the user account 
is created, registration is not required again for future years.
    Based on the number of new TINs registered in the 2017 MIPS 
performance period, we estimate 3,741 eligible clinicians, groups, or 
third-parties will register for new accounts for the 2019 MIPS 
performance period. As shown in Table 68 it would take 1 hour at 
$89.18/hr for a computer systems analyst (or their equivalent) to 
obtain an account for the CMS Enterprise Portal. In aggregate we 
estimate an annual burden of 3,741 hours (3,741 registrations x 1 hr/
registration) at a cost of $333,622 (3,741 hr x $89.18/hr) or $89.18 
per registration.

     Table 68--Estimated Burden for Quality Payment Program Identity
                     Management Application Process
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Number of New TINs completing the Identity Management              3,741
 Application Process (a)................................

[[Page 36023]]

 
Total Hours Per Application (b).........................               1
                                                         ---------------
    Total Annual Hours for completing the Identity                 3,741
     Management Application Process (c) = (a) * (b).....
Cost Per Application @ computer systems analyst's labor           $89.18
 rate of $89.18/hr.) (d)................................
                                                         ---------------
    Total Annual Cost for completing the Identity               $333,622
     Management Application Process (e) = (a) * (d).....
------------------------------------------------------------------------

    Quality Data Submission by Clinicians: Claims-Based Collection 
Type: The proposed requirements and burden associated with clinicians' 
claims-based data submissions will be submitted to OMB for approval 
under control number 0938-1314 (CMS-10621).
    As noted in Table 65, based on 2016 PQRS data and 2017 MIPS 
eligibility data, we assume that 274,702 individual clinicians will 
collect and submit quality data via the claims collection type. We 
continue to anticipate that the claims submission process for MIPS is 
operationally similar to the way the claims submission process 
functioned under the PQRS. Specifically, clinicians will need to gather 
the required information, select the appropriate quality data codes 
(QDCs), and include the appropriate QDCs on the claims they submit for 
payment. Clinicians will collect QDCs as additional (optional) line 
items on the CMS-1500 claim form or the electronic equivalent HIPAA 
transaction 837-P, approved by OMB under control number 0938-1197. This 
rule's proposed provisions would not necessitate the revision of either 
form.
    For this CY 2019 Quality Payment Program rule, we are proposing 
adjustments to the number of respondents based on more recent data and 
adjustments to our per respondent time estimates so that they correctly 
align with the number of required measures for which MIPS data must be 
submitted (6 measures) in comparison to the number of measures 
previously required under PQRS (9 measures).
    The total estimated burden of claims-based submission will vary 
along with the volume of claims on which the submission is based. Based 
on our experience with PQRS, we estimate that the burden for submission 
of MIPS quality data will range from 0.15 to 7.2 hours per clinician, a 
reduction from the range of 0.22 to 10.8 hours as set out in the CY 
2018 Quality Payment Program final rule (82 FR 53912). In the same 
rule, the 33 percent reduction in the number of measures (from 9 to 6) 
was erroneously omitted from our burden calculations; it is reflected 
in this proposed rule's burden estimates. The wide range of estimates 
for the time required for a clinician to submit quality measures via 
claims reflects the wide variation in complexity of submission across 
different clinician quality measures. As shown in Table 69, we estimate 
that the cost of quality data submission using claims will range from 
$13.38 (0.15 hr x $89.18/hr) to $642.10 (7.2 hr x $89.18/hr). The 
burden will involve becoming familiar with MIPS data submission 
requirements. We believe that the start-up cost for a clinician's 
practice to review measure specifications is 7 hours, consisting of 3 
hours at $107.38/hr for a practice administrator, 1 hour at $206.44/hr 
for a clinician, 1 hour at $43.96/hr for an LPN/medical assistant, 1 
hour at $89.18/hr for a computer systems analyst, and 1 hour at $36.98/
hr for a billing clerk.
    The estimate for reviewing and incorporating measure specifications 
for the claims collection type is higher than that of QCDRs/Registries 
or eCQM collection types due to the more manual, and therefore, more 
burdensome nature of claims measures.
    Considering both data submission and start-up requirements, the 
estimated time (per clinician) ranges from a minimum of 7.15 hours 
(0.15 hr + 7 hr) to a maximum of 14.2 hours (7.2 hr + 7 hr). In this 
regard the total annual burden rages from 1,964,119 hours (7.15 hr x 
274,702 clinicians) to 3,900,768 hours (14.2 hr x 274,702 clinicians). 
The estimated annual cost (per clinician) ranges from $712.08 ($13.38 + 
$322.14 + $89.18 + $43.96 + $36.98 + $206.44) to a maximum of $1,340.80 
($642.10 + $322.14 + $89.18 + $43.96 + $36.98 + $206.44). The total 
annual burden ranges from a minimum of $195,609,800 (274,702 clinicians 
x $712.08) to a maximum of $368,320,442 (274,702 clinicians x 
$1,340.80).
    Table 69 summarizes the range of total annual burden associated 
with clinicians submitting quality data via claims.
    Independent of the change in the number of respondents, the change 
in estimated time per clinician results in a burden adjustment of 
between -20,853 hours at -$1,860,081 (278,039 clinicians x -0.075 hr x 
$89.18/hr) and -1,000,941 hours at -$89,261,641 (278,039 clinicians x -
3.6 hr x $89.18/hr). Accounting for the change in the time burden per 
respondent, the decrease in number of respondents results in a total 
adjustment of between -23,860 hours at -$2,376,211 (-3,337 respondents 
x $712.08/respondent) and -47,385 hours at -$4,474,249 (-3,337 
respondents x $1,340.80/respondent). When these two adjustments are 
combined, the net adjustment ranges between -44,713 (-20,853-23,860) 
hours at -$4,236,292 (-$1,860,081-$2,376,211) and -1,048,326 (-
1,000,941-47,385) hours at -$93,735,890 (-$89,261,641-$4,474,249).

                          Table 69--Estimated Burden for Quality Performance Category:
                                   Clinicians Using the Claims Collection Type
----------------------------------------------------------------------------------------------------------------
                                                                                                  Maximum burden
                                                                  Minimum burden   Median burden     estimate
----------------------------------------------------------------------------------------------------------------
Number of Clinicians (a)........................................         274,702         274,702         274,702
Hours Per Clinician to Submit Quality Data (b)..................            0.15            1.05             7.2
Number of Hours Practice Administrator Review Measure                          3               3               3
 Specifications (c).............................................
Number of Hours Computer Systems Analyst Review Measure                        1               1               1
 Specifications (d).............................................

[[Page 36024]]

 
Number of Hours LPN Review Measure Specifications (e)...........               1               1               1
Number of Hours Billing Clerk Review Measure Specifications (f).               1               1               1
Number of Hours Clinician Review Measure Specifications (g).....               1               1               1
Annual Hours per Clinician (h) = (b) + (c) + (d) + (e) + (f) +              7.15            8.05            14.2
 (g)............................................................
                                                                 -----------------------------------------------
    Total Annual Hours (i) = (a) * (h)..........................       1,964,119       2,211,351       3,900,768
Cost to Submit Quality Data (@ computer systems analyst's labor           $13.38          $93.64         $642.10
 rate of $89.18/hr.) (j)........................................
Cost to Review Measure Specifications (@ practice                        $322.14         $322.14         $322.14
 administrator's labor rate of $107.38/hr.) (k).................
Cost to Review Measure Specifications (@ computer systems                 $89.18          $89.18          $89.18
 analyst's labor rate of $89.18/hr.) (l)........................
Cost to Review Measure Specifications (@ LPN's labor rate of              $43.96          $43.96          $43.96
 $43.96/hr.) (m)................................................
Cost to Review Measure Specifications (@ billing clerk's labor            $36.98          $36.98          $36.98
 rate of $36.98/hr.) (n)........................................
Cost to Review Measure Specifications (@ physician's labor rate          $206.44         $206.44         $206.44
 of $206.44/hr.) (o)............................................
                                                                 -----------------------------------------------
    Total Annual Cost Per Clinician (p) = (j) + (k) + (l) + (m)          $712.08         $792.34       $1,340.80
     + (n) + (o)................................................
                                                                 -----------------------------------------------
        Total Annual Cost (q) = (a) * (p).......................    $195,609,800    $217,657,383    $368,320,442
----------------------------------------------------------------------------------------------------------------

    Quality Data Submission by Individuals and Groups Using MIPS CQM 
and QCDR Collection Types: This rule does not propose any new or 
revised reporting, recordkeeping, or third-party disclosure 
requirements related to this quality data submission. However, we are 
proposing adjustments to the number of respondents based on more recent 
data. The adjusted burden will be submitted to OMB for approval under 
control number 0938-1314 (CMS-10621).
    As noted in Tables 65, 66, and 67 and based on the 2016 PQRS data 
and 2017 MIPS eligibility data, we assume that 267,736 clinicians will 
submit quality data as individuals or groups using MIPS CQM or QCDR 
collection types. Of these, we expect 103,268 clinicians, as shown in 
Table 66, to submit as individuals and 3,788 groups, as shown in Table 
67, are expected to submit on behalf of the remaining 164,468 
clinicians. Given that the number of measures required is the same for 
clinicians and groups, we expect the burden to be the same for each 
respondent collecting data via MIPS CQM or QCDR, whether the clinician 
is participating in MIPS as an individual or group.
    Under the MIPS CQM and QCDR collection types, the individual 
clinician or group may either submit the quality measures data directly 
to us, log in and upload a file, or utilize a third-party vendor to 
submit the data to us on the clinician's or group's behalf.
    We estimate that the burden associated with the QCDR collection 
type is similar to the burden associated with the MIPS CQM collection 
type; therefore, we discuss the burden for both together below. For 
MIPS CQM and QCDR collection types, we estimate an additional time for 
respondents (individual clinicians and groups) to become familiar with 
MIPS submission requirements and, in some cases, specialty measure sets 
and QCDR measures. Therefore, we believe that the burden for an 
individual clinician or group to review measure specifications and 
submit quality data total 9.083 hours at $858.86. This consists of 3 
hours at $89.18/hr for a computer systems analyst (or their equivalent) 
to submit quality data along with 2 hours at $107.38/hr for a practice 
administrator, 1 hour at $89.18/hr for a computer systems analyst, 1 
hour at $43.96/hr for a LPN/medical assistant, 1 hour at $36.98/hr for 
a billing clerk, and 1 hour at $206.44/hr for a clinician to review 
measure specifications. Additionally, clinicians and groups will need 
to authorize or instruct the qualified registry or QCDR to submit 
quality measures' results and numerator and denominator data on quality 
measures to us on their behalf. We estimate that the time and effort 
associated with authorizing or instructing the quality registry or QCDR 
to submit this data will be approximately 5 minutes (0.083 hours) per 
clinician or group (respondent) for a cost of $7.40 (0.083 hr x $89.18/
hr for a computer systems analyst).
    In aggregate we estimate an annual burden of 972,390 hours (9.083 
hr/response x 107,056 groups plus clinicians submitting as individuals) 
at a cost of $92,738,331 (107,056 responses x $866.26/response). The 
decrease in number of respondents results in a total adjustment of -
1,462 hours at -$139,467 (-161 respondents x $866.26/respondent). Based 
on these assumptions, we have estimated in Table 70 the burden for 
these submissions.

 Table 70--Estimated Burden for Quality Performance Category: Clinicians
 (Participating Individually or as Part of a Group) Using the MIPS CQM/
                          QCDR Collection Type
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Number of clinicians submitting as individuals (a)......         103,268
Number of groups submitting via QCDR or MIPS CQM on                3,788
 behalf of individual clinicians (b)....................
Number of Respondents (groups plus clinicians submitting         107,056
 as individuals) (c) = (a) + (b)........................
Hours Per Respondent to Report Quality Data (d).........               3
Number of Hours Practice Administrator Review Measure                  2
 Specifications (e).....................................

[[Page 36025]]

 
Number of Hours Computer Systems Analyst Review Measure                1
 Specifications (f).....................................
Number of Hours LPN Review Measure Specifications (g)...               1
Number of Hours Billing Clerk Review Measure                           1
 Specifications (h).....................................
Number of Hours Clinician Review Measure Specifications                1
 (i)....................................................
Number of Hours Per Respondent to Authorize Qualified              0.083
 Registry to Report on Respondent's Behalf (j)..........
Annual Hours Per Respondent (k) = (d) + (e) + (f) + (g)            9.083
 + (h) + (i) + (j)......................................
                                                         ---------------
    Total Annual Hours (l) = (c) * (k)..................         972,390
Cost Per Respondent to Submit Quality Data (@ computer           $267.54
 systems analyst's labor rate of $89.18/hr.) (m)........
Cost to Review Measure Specifications (@ practice                $214.76
 administrator's labor rate of $107.38/hr.) (n).........
Cost Computer System's Analyst Review Measure                     $89.18
 Specifications (@ computer systems analyst's labor rate
 of $89.18/hr.) (o).....................................
Cost LPN Review Measure Specifications (@ LPN's labor             $43.96
 rate of $43.96/hr.) (p)................................
Cost Billing Clerk Review Measure Specifications (@               $36.98
 clerk's labor rate of $36.98/hr.) (q)..................
Cost Clinician Review Measure Specifications (@                  $206.44
 physician's labor rate of $206.44/hr.) (r).............
Cost for Respondent to Authorize Qualified Registry/QCDR           $7.40
 to Report on Respondent's Behalf (@ computer systems
 analyst's labor rate of $89.18/hr.) (s)................
                                                         ---------------
    Total Annual Cost Per Respondent (t) = (m) + (n) +           $866.26
     (o) + (p) + (q) + (r) + (s)........................
                                                         ---------------
        Total Annual Cost (u) = (c) * (t)...............     $92,738,331
------------------------------------------------------------------------

    Quality Data Submission by Clinicians and Groups: eCQM Collection 
Type: This rule does not propose any new or revised reporting, 
recordkeeping, or third-party disclosure requirements related to this 
quality data submission. However, we are proposing adjustments to the 
number of respondents based on more recent data. The adjusted burden 
will be submitted to OMB for approval under control number 0938-1314 
(CMS-10621).
    As noted in Tables 65, 66, and 67, based on 2016 PQRS data and 2017 
MIPS eligibility data, we assume that 129,188 clinicians will elect to 
use the eCQM collection type; 52,028 clinicians are expected to submit 
eCQMs as individuals; and 1,501 groups are expected to submit eCQMs on 
behalf of 77,160 clinicians. We expect the burden to be the same for 
each respondent using the eCQM collection type, whether the clinician 
is participating in MIPS as an individual or group.
    In the CY 2018 Quality Payment Program final rule, the time 
required for users to obtain an account for the CMS Enterprise Portal 
was included in this Quality Data Submission by Clinicians and Groups: 
eCQM Collection Type ICR (82 FR 53914). However, in this CY 2019 
Quality Payment Program rule, we are proposing a separate ICR for this 
activity (now described as the Quality Payment Program Identity 
Management Application Process; see Table 68) and to reduce (by 1 hour) 
our per respondent burden estimate for this ICR commensurately. We are 
also proposing an adjustment to the number of respondents based on more 
recent data.
    Under the eCQM collection type, the individual clinician or group 
may either submit the quality measures data directly to us from their 
eCQM, log in and upload a file, or utilize an eCQM data submission 
vendor to submit the data to us on the clinician's or group's behalf.
    To prepare for the eCQM collection type, the clinician or group 
must review the quality measures on which we will be accepting MIPS 
data extracted from eCQMs, select the appropriate quality measures, 
extract the necessary clinical data from their eCQM, and submit the 
necessary data to the CMS-designated clinical data warehouse or use a 
health IT vendor to submit the data on behalf of the clinician or 
group. We assume the burden for collecting quality measures data via 
eCQM is similar for clinicians and groups who submit their data 
directly to us from their CEHRT and clinicians and groups who use an 
eCQM data submission vendor to submit the data on their behalf. This 
includes extracting the necessary clinical data from their EHR and 
submitting the necessary data to the CMS-designated clinical data 
warehouse.
    We continue to estimate that it will take no more than 2 hours at 
$89.18/hr for a computer systems analyst to submit the actual data 
file. The burden will also involve becoming familiar with MIPS 
submission. In this regard we estimate it would take 6 hours for a 
clinician or group to review measure specifications. Of that time, we 
estimate 2 hours at $107.38/hr for a practice administrator, 1 hour at 
$206.44/hr for a clinician, 1 hour at $89.18/hr for a computer systems 
analyst, 1 hour at $43.96/hr for a LPN/medical assistant, and 1 hour at 
$36.98/hr for a billing clerk.
    In aggregate we estimate an annual burden of 428,232 hours (8 hr x 
53,529 groups and clinicians submitting as individuals) at a cost of 
$41,200,201 (53,529 responses x $769.68/response) (see Table 71).
    Independent of the change in the number of respondents, removing 
the time burden associated with completing the Quality Payment Program 
Identity Management Application Process results in an adjustment to the 
total burden of -54,218 hours and -$4,835,161 (54,218 respondents x -1 
hr x $89.18/hr). Accounting for the change in the per respondent time 
estimate, the decrease in number of respondents results in a total 
adjustment of -5,512 hours at -$530,309 (-689 respondents x $769.68/
respondent). When these two adjustments are combined, the net 
adjustment is -59,730 (-54,218-5,512) hours at -$5,365,470 (-
$4,835,161-$530,309).

[[Page 36026]]



 Table 71--Estimated Burden for Quality Performance Category: Clinicians
     (Submitting Individually or as Part of a Group) Using the eCQM
                             Collection Type
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Number of clinicians submitting as individuals (a)......          52,028
Number of Groups submitting via EHR on behalf of                   1,501
 individual clinicians (b)..............................
Number of Respondents (groups and clinicians submitting           53,529
 as individuals) (c) = (a) + (b)........................
Hours Per Respondent to Submit MIPS Quality Data File to               2
 CMS (d)................................................
Number of Hours Practice Administrator Review Measure                  2
 Specifications (e).....................................
Number of Hours Computer Systems Analyst Review Measure                1
 Specifications (f).....................................
Number of Hours LPN Review Measure Specifications (g)...               1
Number of Hours Billing Clerk Review Measure                           1
 Specifications (h).....................................
Number of Hours Clinicians Review Measure Specifications               1
 (i)....................................................
Annual Hours per Respondent (j) = (d) + (e) + (f) + (g)                8
 + (h) + (i)............................................
                                                         ---------------
    Total Annual Hours (k) = (c) * (j)..................         428,232
Cost Per Respondent to Submit Quality Data (@ computer           $178.36
 systems analyst's labor rate of $88.10/hr.) (l)........
Cost to Review Measure Specifications (@ practice                $214.76
 administrator's labor rate of $105.16/hr.) (m).........
Cost to Review Measure Specifications (@ computer                 $89.18
 systems analyst's labor rate of $88.10/hr.) (n)........
Cost to Review Measure Specifications (@ LPN's labor              $43.96
 rate of $43.12/hr.) (o)................................
Cost to Review Measure Specifications (@ clerk's labor            $36.98
 rate of $36.12/hr.) (p)................................
Cost to D21Review Measure Specifications (@ physician's          $206.44
 labor rate of $202.08/hr.) (q).........................
    Total Cost Per Respondent (r) = (l) + (m) + (n) +            $769.68
     (o) + (p) + (q)....................................
                                                         ---------------
        Total Annual Cost (s) = (c) * (r)...............     $41,200,201
------------------------------------------------------------------------

    Quality Data Submission via CMS Web Interface: The proposed 
requirements and burden associated with this data submission will be 
submitted to OMB for approval under control number 0938-1314 (CMS-
10621).
    As discussed in section III.H.3.h.(2)(a)(ii)(A)(bb) of this rule, 
we are proposing a 40 percent reduction in the number of measures (from 
15 to 9 measures) for which clinicians are required to submit quality 
data via the CMS Web Interface. To account for the decrease in 
measures, we are also proposing to decrease our per respondent time 
estimate.
    We assume that 286 groups will submit quality data via the CMS Web 
Interface based on the number of groups who submitted quality data via 
the CMS Web Interface during the 2018 MIPS performance period. This is 
a decrease of 10 groups from the currently approved number provided in 
the CY 2018 Quality Payment Program final rule (82 FR 53915) due to 
receipt of more current data. We anticipate that approximately 91,757 
clinicians will be represented.
    The burden associated with the group submission requirements is the 
time and effort associated with submitting data on a sample of the 
organization's beneficiaries that is prepopulated in the CMS Web 
Interface. In the CY 2018 Quality Payment Program final rule, we 
estimated that it would take, on average, 74 hours for each group to 
submit quality measures data via the CMS Web Interface (82 FR 53915). 
Of those hours, approximately half (or 37 hr) are unaffected by the 
number of required measures while the other half (37 hr) are affected 
proportionately by the number of required measures (60 percent of 37 hr 
is adjusted to 22.2 hr). Accounting for the proposed reduction in 
required measures, our revised estimate for the time to submit data via 
the CMS Web Interface for the 2019 MIPS performance period is 59.2 
hours (37 hr + 22.2 hr), a reduction of 14.8 hours or 40 percent of the 
currently approved 37 hour time estimate. Considering only the time 
which varies based on the number of required measures, the process of 
entering or uploading data requires approximately 2.5 hours of a 
computer systems analyst's time per measure (22.2 hr/9 measures). Our 
estimate for submission includes the time needed for each group to 
populate data fields in the web interface with information on 
approximately 248 eligible assigned Medicare beneficiaries, submit the 
data (we will partially pre-populate the CMS Web Interface with claims 
data from their Medicare Part A and B beneficiaries). The patient data 
either can be manually entered, uploaded into the CMS Web Interface via 
a standard file format, which can be populated by CEHRT, or submitted 
directly. Each group must provide data on 248 eligible assigned 
Medicare beneficiaries (or all eligible assigned Medicare beneficiaries 
if the pool of eligible assigned beneficiaries is less than 248) for 
each measure. In aggregate we estimate an annual burden of 16,931 hours 
(286 groups x 59.2 hr) at a cost of $1,509,907 (16,931 hr x $89.18/hr).
    Independent of the change in the number of respondents, the 
decrease in total burden resulting from the decrease in required 
measures is -4,381 hours at -$390,679 (296 groups x -14.8 hr x $89.18/
hr). Accounting for the decrease in total time, the decrease in number 
of respondents results in a total adjustment of -592 hours at -$52,794 
(-10 respondents x $5,279/respondent). When these adjustments are 
combined, the net adjustment is -4,973 (-4,381-592) hours at -$443,473 
(-$390,679-$52,794).
    Based on the assumptions discussed in this section, Table 72 
summarizes the burden for groups submitting to MIPS via the CMS Web 
Interface.

 Table 72--Estimated Burden for Quality Data Submission via the CMS Web
                                Interface
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Number of Eligible Group Practices (a)..................             286

[[Page 36027]]

 
Total Annual Hours Per Group to Submit (b)..............            59.2
                                                         ---------------
    Total Annual Hours (c) = (a) * (b)..................          16,931
Cost Per Group to Report (@ computer systems analyst's            $5,279
 labor rate of $89.18/hr.) (d)..........................
                                                         ---------------
    Total Annual Cost (e) = (a) * (d)...................      $1,509,907
------------------------------------------------------------------------

    Beneficiary Responses to CAHPS for MIPS Survey: This rule does not 
propose any new or revised reporting, recordkeeping, or third-party 
disclosure requirements related to the survey. However, we are 
proposing adjustments to our currently approved burden estimates based 
on more recent data. The adjusted burden will be submitted to OMB for 
approval under control number 0938-1222 (CMS-10450).
    In this CY 2019 Quality Payment Program rule, we are proposing 
adjustments to the number of groups electing to report on the CAHPS for 
MIPS survey as well as the average number of beneficiaries per group 
based on more recent data.
    Under MIPS, groups of 25 or more clinicians can elect to contract 
with a CMS-approved survey vendor and use the CAHPS for MIPS survey as 
one of their 6 required quality measures. Beneficiaries that choose to 
respond to the CAHPS for MIPS survey will experience burden.
    The usual practice in estimating the burden on public respondents 
to surveys such as CAHPS is to assume that respondent time is valued, 
on average, at civilian wage rates. As explained in section V.A. of 
this proposed rule, BLS data sets out an average hourly wage for 
civilians in all occupations to be $24.34/hr. Although most Medicare 
beneficiaries are retired, we believe that their time value is unlikely 
to depart significantly from prior earnings expense, and we have used 
the average hourly wage to compute our cost estimate for the 
beneficiaries' time.
    For the 2019 MIPS performance period, we assume that 241 groups 
will elect to report on the CAHPS for MIPS survey, which is equal to 
the number of groups participating in CAHPS for MIPS for the 2017 MIPS 
performance period and a decrease from the 461 groups currently 
approved by OMB. Table 73 shows the estimated annual burden for 
beneficiaries to participate in the CAHPS for MIPS Survey. Based on the 
number of complete and partially complete surveys for groups 
participating in CAHPS for MIPS survey administration for the 2017 MIPS 
performance period, we assume that an average of 273 beneficiaries will 
respond per group for the 2019 MIPS performance period. Therefore, the 
CAHPS for MIPS survey will be administered to approximately 65,793 
beneficiaries per year (241 groups x an average of 273 beneficiaries 
per group responding). This is an adjustment to our currently approved 
132,307 beneficiary estimate.
    The CAHPS for MIPS survey that will be administered in the 2019 
MIPS performance period is unchanged from the survey administered in 
the 2018 MIPS performance period. In that regard we continue to 
estimate an average administration time of 12.9 minutes (or 0.215 hr) 
at a pace of 4.5 items per minute for the English version of the 
survey. For the Spanish version, we estimate an average administration 
time of 15.5 minutes (assuming 20 percent more words in the Spanish 
translation). However, since less than 1 percent of surveys were 
administered in Spanish for reporting year 2016, our burden estimate 
reflects the time for administering the English version of the survey.
    Given that we expect approximately 65,793 respondents, we estimate 
an annual burden of 14,145 hours (65,793 respondents x 0.215 hr/
respondent) at a cost of $344,289 (14,145 hr x $24.34/hr).
    The decrease in the number of beneficiaries responding to the CAHPS 
for MIPS survey results in an adjustment to the total time burden of -
14,301 hours and -$348,087 (-66,514 beneficiaries x 0.215 hr x $24.34/
hr).

  Table 73--Estimated Burden for Beneficiary Participation in CAHPS for
                               MIPS Survey
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Number of Eligible Group Practices Administering CAHPS               241
 for MIPS (a)...........................................
Number of Beneficiaries Per Group Responding to Survey               273
 (b)....................................................
Number of Total Beneficiary Respondents (c) = (a) * (b).          65,793
Number of Hours Per Beneficiary Respondent (d)..........           0.215
Cost (@ labor rate of $24.34/hr.) (e)...................       $24.34/hr
                                                         ---------------
    Total Annual Hours (f) = (c) * (d)..................          14,145
                                                         ---------------
        Total Annual Cost for Beneficiaries Responding          $344,289
         to CAHPS for MIPS (g) = (c) * (e)..............
------------------------------------------------------------------------

    Group Registration for CMS Web Interface: This rule does not 
propose any new or revised reporting, recordkeeping, or third-party 
disclosure requirements related to the group registration. However, we 
are proposing adjustments to our currently approved burden estimates 
based on more recent data. The adjusted burden will be submitted to OMB 
for approval under control number 0938-1222 (CMS-10450).
    In this CY 2019 Quality Payment Program rule, we are proposing to 
adjust the number of respondents based on more recent data and an 
adjustment to our per response time estimate based on our review of the 
currently approved estimates against the existing registration process.

[[Page 36028]]

    Groups interested in participating in MIPS using the CMS Web 
Interface for the first time must complete an on-line registration 
process. After first time registration, groups will only need to opt 
out if they are not going to continue to submit via the CMS Web 
Interface. In Table 74 we estimate that the registration process for 
groups under MIPS involves approximately 0.25 hours at $89.18/hr for a 
computer systems analyst (or their equivalent) to register the group. 
Although the registration process remains unchanged from the CY 2018 
Quality Payment Program final rule, a review of the steps required for 
registration warranted a reduction of 0.75 hours in estimated burden 
per group (82 FR 53917).
    We assume that approximately 67 groups will elect to use the CMS 
Web Interface submission type for the first time during the 2019 MIPS 
performance period based on the number of new registrations received 
during the CY 2018 registration period; an increase of 57 compared to 
the number of groups currently approved by OMB under control number 
0938-1314 (CMS-10621). In aggregate we estimate a burden of 16.75 hours 
(67 new registrations x 0.25 hr/registration) at a cost of $1,494 
(16.75 hr x $89.18/hr).
    Independent of the decrease in time burden per group, the increase 
in the number of groups registering to submit MIPS data via the CMS Web 
Interface results in an adjustment to the total time burden of 57 hours 
at $5,083 (57 groups x 1 hr x $89.18/hr). Accounting for the increase 
in the number of groups, the decrease in time burden per group to 
register results in an adjustment to the total burden of -50.25 hours 
at -$4,481 (67 groups x-0.75 hrs x $89.18/hr). When these adjustments 
are combined, the net adjustment is 6.75 hours (57-50.25) at $602 
($5,083 -$4,481).

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

    Group Registration for CAHPS for MIPS Survey: This rule does not 
propose any new or revised reporting, recordkeeping, or third-party 
disclosure requirements related to the group registration. However, we 
are proposing adjustments to our currently approved burden estimates 
based on more recent data. The adjusted burden will be submitted to OMB 
for approval under control number 0938-1222 (CMS-10450).
    In this CY 2019 Quality Payment Program rule, we are proposing to 
adjust our currently approved number of respondents based on more 
recent data and adjust our per respondent time estimate based on our 
review of the current burden estimates against the existing 
registration process.
    Under MIPS, the CAHPS for MIPS survey counts for 1 measure toward 
the MIPS quality performance category and, as a patient experience 
measure, it also fulfills the requirement to submit at least one high 
priority measure in the absence of an applicable outcome measure. 
Groups that wish to administer the CAHPS for MIPS survey must register 
by June of the applicable 12-month performance period, and 
electronically notify CMS of which vendor they have selected to 
administer the survey on their behalf. For the 2019 MIPS performance 
period, we assume that 454 groups will enroll in the MIPS for CAHPS 
survey based on the number of groups which elected to register during 
the CY 2017 registration period; a decrease of 7 compared to the number 
of groups currently approved by OMB under the aforementioned control 
number (82 FR 53917).
    As shown in Table 75, we assume that the staff involved in the 
group registration for CAHPS for MIPS Survey will mainly be computer 
systems analysts (or their equivalent) who have an average labor cost 
of $89.18/hr. We assume the CAHPS for MIPS Survey registration burden 
consists of 0.25 hours to register for the survey as well as 0.5 hours 
to select the CAHPS for MIPS Survey vendor that will be used and 
electronically notify CMS of their selection. In this regard the total 
time for CAHPS for MIPS registration is 0.75 hours. Although the 
registration process remains unchanged from the CY 2018 Quality Payment 
Program final rule, after we reviewed the steps required for 
registration more thoroughly, we believe that the burden was less than 
we had originally estimated. In that regard we propose to reduce the 
estimated burden from 1.5 hours to 0.75 hours per respondent
    In aggregate we estimate an annual burden of 340.50 hours (454 
groups x 0.75 hr per group) at a cost of $30,366 (340.50 hr x $89.18/
hr).
    Independent of the change in time per group, the decrease in the 
number of groups registering results in an adjustment to the total 
burden of -10.5 hours at -$936 (-7 groups x 1.5 hrs x $89.18/hr). 
Accounting for the decrease in the number of groups registering, the 
decrease in time per group to register results in an adjustment to the 
total burden of -340.5 hours at -$30,366 (454 groups x-0.75 hr x 
$89.18/hr). When these adjustments are combined, the net adjustment is 
-351 hours (-10.5-340.5) at -$31,302 (-$936-$30,366).

  Table 75--Estimated Burden for Group Registration for CAHPS for MIPS
                                 Survey
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Number of Groups Registering for CAHPS (a)..............             454
Total Annual Hours for CAHPS Registration (b)...........            0.75
                                                         ---------------
    Total Annual Hours for CAHPS Registration (c) = (a)            340.5
     * (b)..............................................

[[Page 36029]]

 
Labor Rate to Register for CAHPS (computer systems             $89.18/hr
 analyst) (d)...........................................
                                                         ---------------
    Total Annual Cost for CAHPS Registration (e) = (a) *         $30,366
     (d)................................................
------------------------------------------------------------------------

9. Quality Payment Program ICRs Regarding the Nomination of Quality 
Measures
    This rule does not propose any new or revised reporting, 
recordkeeping, or third-party disclosure requirements related to the 
group registration. However, we are proposing adjustments to our 
currently approved burden estimates based on more recent data. We are 
also proposing to account for burden associated with policies that have 
been finalized but whose burden were erroneously excluded from our 
estimates. The new and adjusted burden will be submitted to OMB for 
approval under control number 0938-1314 (CMS-10621).
    As discussed in section III.H.3.h.(2)(b)(i) of this proposed rule, 
quality measures are selected annually through a call for quality 
measures under consideration, with a final list of quality measures 
being published in the Federal Register by November 1 of each year. 
Under section 1848(q)(2)(D)(ii) of the Act, the Secretary must solicit 
a ``Call for Quality Measures'' each year. Specifically, the Secretary 
must request that eligible clinician organizations and other relevant 
stakeholders identify and submit quality measures to be considered for 
selection in the annual list of MIPS quality measures, as well as 
updates to the measures. Under section 1848(q)(2)(D)(ii) of the Act, 
eligible clinician organizations are professional organizations as 
defined by nationally recognized specialty boards of certification or 
equivalent certification boards.
    As we described in the CY 2017 Quality Payment Program final rule 
(81 FR 77137), we will accept quality measures submissions at any time, 
but only measures submitted during the timeframe provided by us through 
the pre-rulemaking process of each year will be considered for 
inclusion in the annual list of MIPS quality measures for the 
performance period beginning 2 years after the measure is submitted. 
This process is consistent with the pre-rulemaking process and the 
annual call for measures, which are further described at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityMeasures/Pre-Rule-Making.html.
    To identify and submit a quality measure, eligible clinician 
organizations and other relevant stakeholders use a one-page online 
form that requests information on background, gap analysis which 
includes evidence for the measure, reliability validity, endorsement 
and a summary which includes how the proposed measure relates to the 
Quality Payment Program and the rationale for the measure. In addition, 
proposed measures must be accompanied by a completed Peer Review 
Journal Article form.
    As shown in Table 76, we estimate that approximately 140 
organizations, including clinicians, CEHRT developers, and vendors, 
will submit measures for the Call for Quality Measures process; an 
increase of 100 compared to the number of organizations currently 
approved by OMB. In keeping with the focus on clinicians as the primary 
source for recommending new quality measures, we are using practice 
administrators and clinician time for our burden estimates. We also 
estimate it will take 0.5 hours per organization to submit an activity 
to us, consisting of 0.3 hours at $107.38/hr for a practice 
administrator to make a strategic decision to nominate and submit a 
measure and 0.2 hours at $206.44/hr for clinician review time.
    The 0.5 hour estimate assumes that submitters will have the 
necessary information to complete the nomination form readily 
available, which we believe is a reasonable assumption. Additionally, 
some submitters familiar with the process or who are submitting 
multiple measures may require significantly less time, while other 
submitters may require more if the opposite is true; on average we 
believe 0.5 hours is a reasonable average across all submitters.
    Consistent with the CY 2017 Quality Payment Program final rule, we 
also estimate it will take 4 hours at $206.44/hr for a clinician (or 
equivalent) to complete the Peer Review Journal Article Form (81 FR 
77153 through 77155). This assumes that measure information is 
available and testing is complete in order to have the necessary 
information to complete the form, which we believe is a reasonable 
assumption. While the requirement for completing the Peer Review 
Journal Article was previously included in the CY 2017 Quality Payment 
Program final rule, the time required for completing the form was 
erroneously excluded from our burden estimates.
    As shown in Table 76, in aggregate we estimate an annual burden of 
630 hours (140 organizations x 4.5 hr/response) at a cost of $125,896 
(140 x [(0.3 hr x $107.38/hr) + (4.2 hr x $206.44/hr)].
    Independent of the change in time per organization, the change in 
the number of organizations nominating new quality measures results in 
an adjustment of 50 hours at $7,350 (100 organizations x [(0.3 hr x 
$107.38/hr) + (0.2 hr x $206.44/hr)]). When accounting for the change 
in respondents, the change in burden to nominate a quality measure 
results in an adjustment of 560 hours at $115,606 (140 organizations x 
4 hr x $206.44/hr). When these adjustments are combined, the total 
adjustment is 610 hours (560 + 50) at $122,956 ($7,350 + $115,606).

        Table 76--Estimated Burden for Call for Quality Measures
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Number of Organizations Nominating New Quality Measures              140
 (a)....................................................
Number of Hours Per Practice Administrator to Identify              0.30
 and Propose Measure (b)................................
Number of Hours Per Clinician to Identify Measure (c)...            0.20
Number of Hours Per Clinician to Complete Peer Review               4.00
 Article Form (d).......................................

[[Page 36030]]

 
Annual Hours Per Response (e) = (b) + (c) + (d).........            4.50
                                                         ---------------
    Total Annual Hours (f) = (a) * (e)..................             630
Cost to Identify and Submit Measure (@ practice                   $32.21
 administrator's labor rate of $107.38/hr.) (g).........
Cost to Identify Quality Measure and Complete Peer               $867.05
 Review Article Form (@ physician's labor rate of
 $206.44/hr.) (h).......................................
                                                         ---------------
    Total Annual Cost Per Respondent (i) = (g) + (h)....         $899.26
                                                         ---------------
        Total Annual Cost (j) = (a) * (i)...............        $125,896
------------------------------------------------------------------------

10. Quality Payment Program ICRs Regarding Promoting Interoperability 
Data (Sec.  414.1375)
    The proposed requirements and burden discussed under this section 
will be submitted to OMB for approval under control number 0938-1314 
(CMS-10621).
    For the 2019 MIPS performance period, clinicians and groups can 
submit Promoting Interoperability data through direct, log in and 
upload, or log in and attest submission types. We have worked to 
further align the Promoting Interoperability performance category with 
other MIPS performance categories. With the exception of submitters who 
elect to use the log in and attest submission type for the Promoting 
Interoperability performance category which is not available for the 
quality performance category, we anticipate that most organizations 
will use the same data submission type for the both of these 
performance categories and that the clinicians, practice managers, and 
computer systems analysts involved in supporting the quality data 
submission will also support the Promoting Interoperability data 
submission process. Hence, the following burden estimates show only 
incremental hours required above and beyond the time already accounted 
for in the quality data submission process. While this analysis 
assesses burden by performance category and submission type, we 
emphasize that MIPS is a consolidated program and submission analysis 
and decisions are expected to be made for the program as a whole.
    Promoting Interoperability Reweighting Applications: As established 
in the CY 2017 and CY 2018 Quality Payment Program final rules, MIPS 
eligible clinicians who meet the criteria for a significant hardship or 
other type of exception may submit an application requesting a zero 
percent weighting for the Promoting Interoperability performance 
category in the following circumstances: Insufficient internet 
connectivity, extreme and uncontrollable circumstances, lack of control 
over the availability of CEHRT, and decertified EHR technology (81 FR 
77240 through 77243 and 82 FR 53680 through 53686).
    Table 77 summarizes the burden for clinicians to apply for 
reweighting the Promoting Interoperability performance category to zero 
percent due to a significant hardship exception (including a 
significant hardship exception for small practices) or as a result of a 
decertification of an EHR. Participation data for the 2017 MIPS 
performance period was unavailable in time for this proposed rule. 
However, assuming that the actual participation data for the 2017 MIPS 
performance period is available in time to meet our final rule's 
publication schedule, we will use this data and revise our estimates in 
that rule. As a result, we assume 87,211 respondents (eligible 
clinicians or groups) will submit a request to reweight the Promoting 
Interoperability performance category to zero percent due to a 
significant hardship (including small practices) or EHR decertification 
through the Quality Payment Program based on 2016 data from the 
Medicare EHR Incentive Program and the first 2019 payment year MIPS 
eligibility and special status file. We estimate that 5,941 respondents 
(eligible clinicians or groups) will submit a request for reweighting 
the Promoting Interoperability performance category to zero percent due 
to extreme and uncontrollable circumstances, insufficient internet 
connectivity, lack of control over the availability of CEHRT, or as a 
result of a decertification of an EHR. An additional 81,270 respondents 
will submit a request for reweighting the Promoting Interoperability 
performance category to zero percent as a small practice experiencing a 
significant hardship. In total, this represents an increase of 46,566 
from the number of respondents currently approved by OMB.
    The application to request a reweighting to zero percent for the 
Promoting Interoperability performance category is a short online form 
that requires identifying the type of hardship experienced or whether 
decertification of an EHR has occurred and a description of how the 
circumstances impair the ability to submit Promoting Interoperability 
data, as well as some proof of circumstances beyond the clinician's 
control. We estimate it would take 0.25 hours at $89.18/hr for a 
computer system analyst to submit the application. This is a reduction 
from the 0.5 hours estimated in the CY 2018 Quality Payment Program 
final rule due to a revised assessment of the application process (82 
FR 53918). As shown in Table 77, in aggregate we estimate an annual 
burden of 21,803 hours (87,211 applications x 0.25 hr/application) at a 
cost of $1,944,369 (21,803 hr x $89.18/hr).
    Independent of the change to the number of respondents, the 
decrease in the amount of time to submit a reweighting application 
results in an adjustment of -10,161.25 hours at -$906,180 (40,645 
respondents x -0.25 hr x $89.18/hr). Accounting for the decrease in 
time per respondent, the increase in the number of respondents 
submitting reweighting applications results in an adjustment of 
11,641.5 hours at $1,038,188 (46,566 respondents x 0.25 hr x $89.18 
hr). When these adjustments are combined, the total adjustment is 
1,480.25 hours (11,641.5-10,161.25) at $132,008 ($1,038,188-$906,180).

[[Page 36031]]



  Table 77--Estimated Burden for Promoting Interoperability Reweighting
                              Applications
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Number of Eligible Clinicians or Groups Applying Due to            5,941
 Significant Hardship and Other Exceptions (a)..........
Number of Eligible Clinicians or Groups Applying Due to           81,270
 Significant Hardship as Small Practice (b).............
Total Respondents Due to Hardships, Other Exceptions and          87,211
 Hardships for Small Practices (c)......................
Hours Per Applicant per application submission (d)......            0.25
                                                         ---------------
    Total Annual Hours (e) = (a) * (c)..................       21,802.75
Labor Rate for a computer systems analyst (f)...........       $89.18/hr
                                                         ---------------
    Total Annual Cost (g) = (a) * (f)...................      $1,944,369
------------------------------------------------------------------------

    Submitting Promoting Interoperability Data: In this CY 2019 Quality 
Payment Program proposed rule, we are proposing an adjustment to the 
number of respondents based on more recent data and a decrease to the 
per respondent time estimate due to our proposed net reduction of 3 
measures (6 removed measures and 3 new measures) for which clinicians 
are required to submit data, as discussed in section III.H.3.h.(5)(f) 
of this proposed rule.
    A variety of organizations will submit Promoting Interoperability 
data on behalf of clinicians. Clinicians not participating in a MIPS 
APM may submit data as individuals or as part of a group. In the CY 
2017 Quality Payment Program final rule (81 FR 77258 through 77260, 
77262 through 77264), we established that eligible clinicians in MIPS 
APMS other than the Shared Savings Program may submit data for the 
Promoting Interoperability performance category as individuals or as 
part of a group, whereas eligible clinicians participating in the 
Shared Savings Program are limited to submitting data through the ACO 
participant TIN. In section III.H.3.h.(6)(c)(ii) of this proposed rule, 
we propose to extend this flexibility to allow for both individual and 
group reporting by eligible clinicians participating in the Shared 
Savings Program.
    Because group TINs in APM Entities are able to submit Promoting 
Interoperability data to fulfill the requirements of submitting to 
MIPS, we have included MIPS APMs groups in our burden estimates for the 
Promoting Interoperability performance category. Consistent with the 
list of APMs that are MIPS APMs on the Quality Payment Program 
website,\45\ we assume that 3 MIPS APMs that do not also qualify as 
Advanced APMs will operate in the 2019 MIPS performance period: Track 1 
of the Shared Savings Program, CEC (one-sided risk arrangement), and 
the OCM (one-sided risk arrangement). Further, we assume that group 
TINs will submit Promoting Interoperability data on behalf of partial 
QPs that elect to participate in MIPS. We plan to revisit these 
assumptions as when we receive data submitted for the 2017 MIPS 
performance period.
---------------------------------------------------------------------------

    \45\ https://www.cms.gov/Medicare/Quality-Payment-Program/Resource-Library/Comprehensive-List-of-APMs.pdf.
---------------------------------------------------------------------------

    As shown in Table 78, based on data from the 2016 Medicare and 
Medicaid EHR Incentive Programs, the 2016 PQRS data, and 2017 MIPS 
eligibility data, we estimate that 50,878 individual MIPS eligible 
clinicians and 2,998 groups will submit Promoting Interoperability 
data. These estimates reflect that under the policies in the CY 2017 
Quality Payment Program final rule and in the CY 2018 Quality Payment 
Program final rule, certain MIPS eligible clinicians will be eligible 
for automatic reweighting of the Promoting Interoperability performance 
category to zero percent, including MIPS eligible clinicians that are 
hospital-based, ambulatory surgical center-based, non-patient facing 
clinicians, physician assistants, nurse practitioners, clinician nurse 
specialists, and certified registered nurse anesthetists (81 FR 77238 
through 77245 and 82 FR 53680 through 53687). As discussed in section 
III.H.3.h.(5)(h)(ii) of this proposed rule, starting with the 2021 MIPS 
payment year, we are proposing to automatically reweight the Promoting 
Interoperability performance category for clinician types new to MIPS: 
Physical therapists, occupational therapists, clinical social workers, 
and clinical psychologists. These estimates also account for the 
reweighting exceptions finalized in the CY 2017 and CY 2018 Quality 
Payment Program final rules, including for MIPS eligible clinicians in 
small practices, as well as exceptions due to decertification of an 
EHR.
    Further, we anticipate that the 460 Shared Savings Program Track 1 
ACOs will submit data at the ACO participant TIN-level, for a total of 
13,537 group TINs. We anticipate that the three APM Entities electing 
the one-sided track in the CEC model will submit data at the group TIN-
level, for a total of 17 group TINs submitting data. And finally, we 
anticipate that the 192 APM Entities in the OCM (one-sided risk 
arrangement) will submit data at APM Entity level. The total estimated 
number of respondents is estimated at 67,622.

      Table 78--Estimated Number of Respondents To Submit Promoting
        Interoperability Performance Data on Behalf of Clinicians
------------------------------------------------------------------------
                                                             Number of
                                                            respondents
------------------------------------------------------------------------
Number of individual clinicians to submit Promoting               50,878
 Interoperability (a)...................................
Number of groups to submit Promoting Interoperability              2,998
 (b)....................................................
Shared Savings Program ACO Group TINs (c)...............          13,537
CEC one-sided risk track participants \46\ (d)..........              17
OCM one-sided risk arrangement Group TINs (e)...........             192
                                                         ---------------

[[Page 36032]]

 
    Total (f) = (a) + (b) + (c) + (d) + (e).............          67,622
------------------------------------------------------------------------

    While we estimate that 67,622 respondents will be submitting data 
under the Promoting Interoperability performance category, this 
reduction of 150,593 respondents from the currently approved total of 
218,215 is a result of more accurate estimation of the number of 
hospital-based MIPS eligible clinicians, clinicians in small practices, 
and the number of group TINs submitting for MIPS APMs; and also 
accounting for respondents which may submit data via two or more 
submission or collection types and would thus be double-counted 
otherwise.
---------------------------------------------------------------------------

    \46\ The 3 CEC APM Entities reflected in the burden estimate are 
the non-large dialysis organizations participating in the one-sided 
risk track.
---------------------------------------------------------------------------

    In the CY 2018 Quality Payment Program final rule we estimated it 
takes 3 hours for a computer system analyst to collect and submit 
Promoting Interoperability performance category data (82 FR 53920). For 
this proposed rule, we estimate the time required to submit such data 
should be reduced by 20 minutes to 2.67 hours due to our proposal to 
reduce the number of measures for which clinicians are required to 
submit data, as discussed in section III.H.3.h.(5)(f) of this proposed 
rule. As shown in Table 79, the total time for an organization to 
submit data on the specified Promoting Interoperability objectives and 
measures is estimated to be 180,325 hours (67,622 respondents x 2.67 
incremental hours for a computer analyst's time above and beyond the 
clinician, practice manager, and computer system's analyst time 
required to submit quality data) at a cost of $16,081,413 (180,325 hr x 
$89.18/hr).
    Independent of the change in the number of respondents, the 
reduction in estimated time to submit Promoting Interoperability data 
results in a decrease in burden of -72,738.33 hours at -$6,486,805 
(218,215 respondents x-0.33 hr x $89.18/hr). Acccounting for the 
decreased per respondent time, the decrease in the number of 
respondents results in an adjustment to the total burden of -401,581.33 
hours at -$35,813,023 (-150,593 respondents x 2.67 hrs x $89.18/hr). 
When these adjustments are combined, the total adjustment is -
474,319.67 hours (-72,738.33-401,581.33) at -$42,299,828 (-$6,486,805-
$35,813,023).

  Table 79--Estimated Burden for Promoting Interoperability Performance
                        Category Data Submission
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Number of respondents submitting Promoting                        67,622
 Interoperability data on behalf of clinicians (a)......
Total Annual Hours Per Respondent (b)...................            2.67
                                                         ---------------
    Total Annual Hours (c) = (a) * (b)..................         180,325
Labor rate for a computer systems analyst to submit            $89.18/hr
 Promoting Interoperability data/hr.) (d)...............
                                                         ---------------
    Total Annual Cost (e) = (a) * (d)...................     $16,081,413
------------------------------------------------------------------------

11. Quality Payment Program ICRs Regarding the Nomination of Promoting 
Interoperability (PI) Measures
    This rule does not propose any new or revised reporting, 
recordkeeping, or third-party disclosure requirements related to the 
nomination of Promoting Interoperability measures. However, we are 
proposing adjustments to our currently approved burden estimates based 
on more recent data. The adjusted burden will be submitted to OMB for 
approval under control number 0938-1314 (CMS-10621).
    Consistent with our requests for stakeholder input on quality 
measures and improvement activities, we are also requesting potential 
measures for the Promoting Interoperability performance category that 
measure patient outcomes, emphasize patient safety, support improvement 
activities and the quality performance category, and build on the 
advanced use of CEHRT using 2015 Edition standards and certification 
criteria. Promoting Interoperability measures may be submitted via a 
designated submission form that includes the measure description, 
measure type (if applicable), reporting requirement, and CEHRT 
functionality used (if applicable).
    We estimate 47 organizations will submit Promoting Interoperability 
measures, based on the number of organizations submitting measures 
during the CY 2017 nomination period. This is an increase of 7 from the 
estimate currently approved by OMB under the aforementioned control 
number. We estimate it will take 0.5 hours per organization to submit 
an activity to us, consisting of 0.3 hours at $107.38/hr for a practice 
administrator to make a strategic decision to nominate that activity 
and submit an activity to us via email and 0.2 hours at $206.44/hr for 
a clinician to review the nomination. As shown in Table 80, in 
aggregate we estimate an annual burden of 235 hours (47 organizations x 
0.5 hr/response) at a cost of $3,455 (47 x [(0.3 hr x $107.38/hr) + 
(0.2 hr x $206.44/hr)]. The increase in the number of respondents 
results in an adjustment of 3.5 hours and $514.50 (7 respondents x 0.5 
hrs x $73.50 per respondent).

[[Page 36033]]



   Table 80--Estimated Burden for Call for Promoting Interoperability
                                Measures
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Number of Organizations Nominating New Promoting                      47
 Interoperability Measures (a)..........................
Number of Hours Per Practice Administrator to Identify              0.30
 and Propose Measure (b)................................
Number of Hours Per Clinician to Identify Measure (c)...            0.20
Annual Hours Per Respondent (d) = (b) + (c).............            0.50
                                                         ---------------
    Total Annual Hours (e) = (a) * (d)..................           23.50
Cost to Identify and Submit Measure (@practice                    $32.21
 administrator's labor rate of $107.38/hr.) (f).........
Cost to Identify Improvement Measure (@ physician's               $41.29
 labor rate of $206.44/hr.) (g).........................
                                                         ---------------
    Total Annual Cost Per Respondent (h) = (f) + (g)....          $73.50
                                                         ---------------
        Total Annual Cost (i) = (a) * (h)...............          $3,455
------------------------------------------------------------------------

12. Quality Payment Program ICRs Regarding Improvement Activities 
Submission (Sec. Sec.  414.1305, 414.1355, 414.1360, and 414.1365)
    The proposed requirements and burden discussed under this section 
will be submitted to OMB for approval under control number 0938-1314 
(CMS-10621).
    We refer readers to the CY 2017 Quality Payment Program final rule 
(81 FR 77511 through 77512) and the CY 2018 Quality Payment Program 
final rule (82 FR 53920 through 53922) for our previous burden 
estimates for improvement activities under the Quality Payment Program.
    The CY 2018 Quality Payment Program final rule provides: (1) That 
for activities that are performed for at least a continuous 90 days 
during the performance period, MIPS eligible clinicians must submit a 
``yes'' response for activities within the Improvement Activities 
Inventory (82 FR 53651); (2) that the term ``recognized'' is accepted 
as equivalent to the term ``certified'' when referring to the 
requirements for a patient-centered medical home and would receive full 
credit for the improvement activities performance category (82 FR 
53649); and (3) that for the 2020 MIPS payment year and future years, 
to receive full credit as a certified or recognized patient-centered 
medical home or comparable specialty practice, at least 50 percent of 
the practice sites within the TIN must be recognized as a patient-
centered medical home or comparable specialty practice (82 FR 53655).
    In the CY 2017 Quality Payment Program final rule, we describe how 
we determine MIPS APM scores (81 FR 77185). We compare the requirements 
of the specific MIPS APM with the list of activities in the Improvement 
Activities Inventory and score those activities in the same manner that 
they are otherwise scored for MIPS eligible clinicians (81 FR 77817 
through 77831). If, by our assessment, the MIPS APM does not receive 
the maximum improvement activities performance category score, then the 
APM Entity can submit additional improvement activities, although, as 
we noted, we anticipate that MIPS APMs in the 2019 MIPS performance 
period will not need to submit additional improvement activities as the 
models will already meet the maximum improvement activities performance 
category score (81 FR 77185).
    A variety of organizations and in some cases, individual 
clinicians, will submit improvement activity performance category data. 
For clinicians who are not part of APMs, we assume that clinicians 
submitting quality data as part of a group through direct, log in and 
upload, and CMS Web Interface submission types will also submit 
improvement activities data. In the CY 2017 Quality Payment Program 
final rule (81 FR 77264), APM Entities only need to report improvement 
activities data if the CMS-assigned improvement activities score is 
below the maximum improvement activities score. Our CY 2018 Quality 
Payment Program final rule burden estimates assumed that all APM 
Entities will receive the maximum CMS-assigned improvement activities 
score (82 FR 53921 through 53922).
    As represented in Table 81, we estimate that 387,347 clinicians 
will submit improvement activities as individuals during the 2019 MIPS 
performance period, 5,575 groups will submit improvement activities on 
behalf of clinicians, and an additional 16 virtual groups will submit 
improvement activities, resulting in 392,938 total respondents.
    The estimate of 387,347 individual clinicians is a distinct count 
by TIN/NPI of clinicians who submitted quality data under 2016 PQRS 
using an individual submission mechanism (claims, EHR, QCDR/Registry) 
and accounts for clinicians who submitted data using multiple 
submission mechanisms in order to increase the accuracy of our estimate 
of the number of individuals who will submit improvement activities. 
However, actual participation data for the 2017 MIPS performance period 
was unavailable in time for this proposed rule. Assuming actual 
participation data for the 2017 MIPS performance period is available in 
time to meet our final rule's publication schedule, we will use that 
data and revise our estimates in that rule.
    Our burden estimates assume there will be no improvement activities 
burden for MIPS APM participants. We will assign the improvement 
activities performance category score at the APM level. We also assume 
that the MIPS APM models for the 2019 MIPS performance period will 
qualify for the maximum improvement activities performance category 
score and the APM Entities will not need to submit any additional 
improvement activities. Again, assuming actual participation data for 
the 2017 MIPS performance period is available in time to meet 
publication schedule for the final rule, we will use that data and 
revise our estimates in that rule. In Table 81, we estimate that 
approximately 392,938 respondents will be submitting data under the 
improvement activities performance category.

[[Page 36034]]



   Table 81--Estimated Numbers of Organizations Submitting Improvement
      Activities Performance Category Data on Behalf of Clinicians
------------------------------------------------------------------------
                                                               Count
------------------------------------------------------------------------
Number of clinicians to participate in improvement               387,347
 activities data submission as individuals during the
 2019 MIPS performance period (a).......................
Number of Groups to submit improvement activities on               5,575
 behalf of clinicians during the 2019 MIPS performance
 period (b).............................................
Number of Virtual Groups to submit improvement                        16
 activities on behalf of clinicians during the 2019 MIPS
 performance period (c).................................
                                                         ---------------
    Total Number of Respondents (Groups, Virtual Groups,         392,938
     and Individual Clinicians) to submit improvement
     activities data on behalf of clinicians during the
     2019 MIPS performance period (d) = (a) + (b) + (c).
                                                         ---------------
    Total Number of Respondents (Groups, Virtual Groups,         439.786
     and Individual Clinicians) to submit improvement
     activities data on behalf of clinicians during the
     2018 MIPS performance period (e)...................
Difference between 2019 MIPS performance period and 2018         -46,848
 MIPS performance period (f) = (d)-(e)..................
------------------------------------------------------------------------

    As described in section III.H.3.h.(4)(b) of this preamble, for 
purposes of the 2021 MIPS payment year, we are proposing to revise 
Sec.  414.1360(a)(1) to more accurately reflect the data submission 
process for the improvement activities performance category. In 
particular, instead of ``via qualified registries; EHR submission 
mechanisms; QCDR, CMS Web Interface; or attestation,'' as currently 
stated, we are revising the first sentence to state that data would be 
submitted ``via direct, log in and upload, and log in and attest.'' The 
revision would more closely align with the actual submission experience 
users have. We propose to decrease our burden estimates since the 
actual submission experience of the user is such that improvement 
activities data is submitted as part of the process for submitting 
quality and Promoting Interoperability data, resulting in less 
additional required time to submit improvement activities data.
    The CY 2018 Quality Payment Program final rule, we estimated it 
would take 1 hour for a computer system analyst to submit data on the 
specified improvement activities (82 FR 53922). As a result of our 
proposal, we estimate that the per response time required per 
individual or group is 5 minutes at $89.18/hr for a computer system 
analyst to submit by logging in and manually attesting that certain 
activities were performed in the form and manner specified by CMS with 
a set of authenticated credentials. Additionally, as stated in the CY 
2018 Quality Payment Program final rule, the same improvement activity 
may be reported across multiple performance periods so many MIPS 
eligible clinicians will not have any additional information to submit 
for the 2019 MIPS performance period (82 FR 53921).
    We are also proposing to add 6 new improvement activities for CY 
2019 and future years, modify 5 existing improvement activities for CY 
2019 and future years, and remove 1 existing improvement activity for 
CY 2019 and future years. Because MIPS eligible clinicians are still 
required to submit the same number of activities, we do not expect 
these proposals to affect our collection of information burden 
estimates. In addition, in order for an eligible clinician or group to 
receive credit for being a patient-centered medical home or comparable 
specialty practice, the eligible clinician or group must attest in the 
same manner as any other improvement activity.
    As shown in Table 82, we estimate an annual burden of 32,745 hours 
(392,938 responses x 5 minutes/60) at a cost of $2,920,199 (32,745 hr x 
$89.18/hr). Differences from the CY 2018 Quality Payment Program rule 
are based on updated QP data from the 2017 MIPS performance period, 
specifically the APM Participation List for the third snapshot date of 
the 2017 QP performance period.
    Independent of the change to our per response time estimate, the 
decrease in the number of respondents results in an adjustment of -
46,848 hours at -$4,177,904 (-46,848 respondents x 1 hr x $89.18/hr). 
Accounting for the change in number of respondents, the decrease in the 
time to submit improvement activities data results in an adjustment of 
-360,193 hours at -$32,122,027 (392,938 respondents x 55 minutes/60 x 
$89.18/hr). When these adjustments are combined, the total adjustment 
is -407,041 hours (-46,848-360,193) hours at -$36,299,931 (-$4,177,904-
$32,122,027).

    Table 82--Estimated Burden for Improvement Activities Submission
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Total Number of Respondents (Groups, Virtual Groups, and         392,938
 Individual Clinicians) to submit improvement activities
 data on behalf of clinicians during the 2019 MIPS
 performance period (a).................................
Total Annual Hours Per Respondent (b)...................       5 minutes
                                                         ---------------
    Total Annual Hours (c)..............................          32,745
Labor rate for a computer systems analyst to submit            $89.18/hr
 improvement activities (d).............................
                                                         ---------------
    Total Annual Cost (e) = (a) * (d)...................      $2,920,184
------------------------------------------------------------------------

13. Quality Payment Program ICRs Regarding the Nomination of 
Improvement Activities (Sec.  414.1360)
    The proposed requirements and burden discussed under this section 
will be submitted to OMB for approval under control number 0938-1314 
(CMS-10621).
    We refer readers to the CY 2018 Quality Payment Program final rule 
for our previous burden estimates for nomination of improvement 
activities under the Quality Payment Program (82 FR 53922). In this CY 
2019 Quality Payment Program rule, we are proposing

[[Page 36035]]

to adjust the number of respondents based on more recent data and 
adjust our per response time estimate based on our review of our 
currently approved burden estimates against the existing process for 
nomination of improvement activities. We are also proposing to adopt 
one new criteria and remove one existing criteria for nominating new 
improvement activities beginning with the CY 2019 performance period 
and future years. Furthermore, we are making clarifications to: (1) 
Considerations for selecting improvement activities for the CY 2019 
performance period and future years; and (2) the weighting of 
improvement activities. We believe these proposals will not affect our 
currently approved burden estimates since they do not substantively 
impact the level of effort previously estimated to nominate an 
Improvement Activity.
    We are also proposing to change the performance year for which the 
nominations would apply, such that improvement activities nominations 
received in a particular year will be vetted and considered for the 
next year's rulemaking cycle for possible implementation in the 
following year. Additionally, we are modifying the Improvement Activity 
submission form by adding a data field to allow submitters to clearly 
denote submission of a modification. This is to clarify the process for 
submitting modifications of existing Improvement Activities as 
discussed in the CY 2018 Quality Payment Program final rule (82 FR 
53656). Finally, we are proposing to change the submission timeframe 
for the Call for Activities from February 1st through March 1st to 
February 1st through June 30th providing approximately four additional 
months for stakeholders to submit nominations. We believe these 
proposals will not affect our our currently approved burden estimates 
since we believe that the number of nominations is unlikely to change, 
but the quality of the nominations is likely to increase given the 
additional time provided.
    For the 2018 MIPS performance period, we provided opportunity for 
stakeholders to propose new activities formally via the Annual Call for 
Activities nomination form that was posted on the CMS website (82 FR 
53657). The 2018 Annual Call for Activities lasted from March 2, 2017 
through March 1, 2018 for which we received 72 nominations consisting 
of a total of 125 activities which were evaluated for the Improvement 
Activities Under Consideration (IAUC) list for possible inclusion in 
the CY 2019 Improvement Activities Inventory. Based on the number of 
activities being evaluated during the 2018 Annual Call for Activities 
(125 activities), we estimate that the total number of nominations we 
will receive for the 2019 Annual Call for Activities would continue to 
be 125, unchanged from the number of activities evaluated in CY 2018, 
which is a decrease from the 150 nominations currently approved by OMB.
    In the CY 2018 Quality Payment Program final rule, we estimated 
that it takes 0.5 hours to nominate an improvement activity (82 FR 
53922). As shown in Table 83, due to a review of the nomination process 
including the criteria required to nominate an improvement activity, we 
now estimate it would take 2 hours (per organization) to submit an 
activity to us. Of those hours, we estimate it would take 1.2 hours at 
$107.38/hr for a practice administrator or equivalent to make a 
strategic decision to nominate and submit that activity and 0.8 hours 
at $206.44/hr for a clinician's review. In aggregate we estimate an 
annual burden of 250 hours (125 nominations x 2 hr/nomination) at a 
cost of $36,751 (125 x [(1.2 hr x $107.38/hr) + (0.8 hr x $206.44/
hr)]).
    The percentage of practice administrator and clinician labor in 
relation to the total is unchanged from the CY 2018 Quality Payment 
Program final rule (82 FR 53922).
    Independent of the change to our per response time estimate, the 
decrease in the number of nominations results in an adjustment of -12.5 
hours and -$1,837 (-25 activities x [(0.3 hr x $107.38/hr) + (0.2 hr x 
$206.44/hr)]). Accounting for the decrease in the number of nominated 
improvement activities, the increase in time per nominated improvement 
activity results in an adjustment of 187.5 hours and $27,563 (125 
activities x [(0.9 hr x $107.38/hr) + (0.6 hr x $206.44/hr)]). When 
these adjustments are combined, the total adjustment is 175 hours 
(187.5 -12.5) and $25,726 ($27,563 -$1,837).

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

14. Quality Payment Program ICRs Regarding CMS Study on Factors 
Associated With Reporting Quality Measures
    During each performance year, eligible clinicians are recruited to 
participate in the CMS study on the burden associated with reporting 
quality measures. Eligible clinicians who are interested in 
participating can sign up whereby an adequate sample size is then 
selected by CMS from this group of potential participants. This study 
is ongoing, and participants are recruited on a yearly basis. Current 
participants can sign up when the study year ends.
    Section 1848(s)(7) of the Act, as added by section 102 of the MACRA 
(Pub. L. 114-10) states that Chapter 35 of title 44, United States 
Code, shall not apply to the collection of information for the 
development of quality measures. Consequently, we are not setting out 
such burden since the study shall inform us (and our contractors) on 
the root causes of clinicians' performance measure data collection and 
data submission burdens and challenges that hinders accurate and timely 
quality

[[Page 36036]]

measurement activities. We refer readers to the discussion of this 
policy in the regulatory impact analysis section (section VII.F.7) of 
this proposed rule.
15. Quality Payment Program ICRs Regarding the Cost Performance 
Category (Sec.  414.1350)
    The cost performance category relies on administrative claims data. 
The Medicare Parts A and B claims submission process (OMB control 
number 0938-1197) is used to collect data on cost measures from MIPS 
eligible clinicians. MIPS eligible clinicians are not required to 
provide any documentation by CD or hardcopy. Moreover, this rule's 
proposed provisions would not necessitate the need to add or revise or 
delete any claims data fields. Therefore, we do not anticipate any new 
or additional submission requirements and/or burden for MIPS eligible 
clinicians.
16. Quality Payment Program ICRs Regarding Partial QP Elections (Sec.  
414.1430)
    This rule does not propose any new or revised reporting, 
recordkeeping, or third-party disclosure requirements related to QP 
elections. However, we are proposing adjustments to our currently 
approved burden estimates based on more recent data. The adjusted 
burden will be submitted to OMB for approval under control number 0938-
1314 (CMS-10621).
    APM Entities may face a data submission burden under MIPS related 
to Partial QP elections. Advanced APM participants will be notified 
about their QP or Partial QP status as soon as possible after each QP 
determination. Where Partial QP status is earned at the APM Entity 
level the burden of Partial QP election would be incurred by a 
representative of the participating APM Entity. Where Partial QP status 
is earned at the eligible clinician level, the burden of Partial QP 
election would be incurred by the eligible clinician. For the purposes 
of this burden estimate, we assume that all MIPS eligible clinicians 
determined to be Partial QPs will participate in MIPS.
    Based on our predictive QP analysis for the 2019 QP performance 
period, we estimate that 6 APM Entities and 75 eligible clinicians will 
make the election to participate as a Partial QP in MIPS (see Table 
84), an increase of 64 from the 17 elections currently approved by OMB 
under the aforementioned control number. We estimate it will take the 
APM Entity representative or eligible clinician 15 minutes (0.25 hr) to 
make this election. In aggregate we estimate an annual burden of 20.25 
hours (81 respondents x .25 hr/election) at a cost of $1,805.90 (20.25 
hours x $89.18/hr). The increase in the number of Partial QP elections 
results in an adjustment of 16 hours and $1,431 (64 elections x 0.25 
hrs x $89.18/hr).

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

17. Quality Payment Program ICRs Regarding Other Payer Advanced APM 
Determinations: Payer-Initiated Process (Sec.  414.1440) and Eligible 
Clinician Initiated Process (Sec.  414.1445)
    As indicated below, the proposed requirements and burden discussed 
under this section will be submitted to OMB for approval under control 
number 0938-1314 (CMS-10621).
    Payer Initiated Process (Sec.  414.1440): This rule does not 
propose any new or revised reporting, recordkeeping, or third-party 
disclosure requirements related to the Payer Initiated Process. 
However, we are proposing adjustments to our currently approved burden 
estimates based on more recent data. The adjusted burden will be 
submitted to OMB for approval under control number 0938-1314 (CMS-
10621).
    Beginning in Quality Payment Program Year 3, the All-Payer 
Combination Option will be an available pathway to QP status for 
eligible clinicians participating sufficiently in Advanced APMs and 
Other Payer Advanced APMs. The All-Payer Combination Option allows for 
eligible clinicians to achieve QP status through their participation in 
both Advanced APMs and Other Payer Advanced APMs. In order to include 
an eligible clinician's participation in Other Payer Advanced APMs in 
their QP threshold score, we will need to determine if certain payment 
arrangements with other payers meet the criteria to be Other Payer 
Advanced APMs. To provide eligible clinicians with advance notice prior 
to the start of a given performance period, and to allow other payers 
to be involved prospectively in the process, the 2018 CY Quality 
Payment Program final rule established a payer-initiated process for 
identifying payment arrangements that qualify as Other Payer Advanced 
APMs (82 FR 53844). The payer-initiated process for Other Payer 
Advanced APM determinations began in CY 2018 for Medicaid, Medicare 
Health Plans, and payers participating in CMS multi-payer models. 
Payers seeking to submit payment arrangement information for Other 
Payer Advanced APM determination through the payer-initiated process 
are required to complete a Payer Initiated Submission Form, 
instructions for which can be found at https://qpp.cms.gov/Determinations made in 2018 are applicable for the Quality Payment 
Program Year 3. Also in that rule the remaining other payers, including 
commercial and other private payers, may request that we determine 
whether other payer arrangements are Other Payer Advanced APMs starting 
prior to the 2020 QP performance period and each performance period 
thereafter (82 FR 53867).
    As shown in Table 85, we estimate that in 2019 for the 2020 QP 
performance period 165 payer-initiated requests for Other Payer 
Advanced APM determinations will be submitted (15 Medicaid payers, 100 
Medicare Advantage Organizations, and 50 Multi-payers), a decrease of 
135 from the 300 total requests currently approved by OMB under the 
aforementioned control number. We estimate it would take 10 hours at 
$89.18/hr for a computer system analyst per arrangement submission. In 
aggregate we estimate an annual burden of 1,650 hours (165 submissions 
x 10 hr/submission) at a cost of $147,147 (1,650 hr x $89.18/hr). The 
decrease in the number of payer-

[[Page 36037]]

initiated requests results in an adjustment of -1,350 hours and -
$120,393 (-135 requests x 10 hr x $89.18/hr).

 Table 85--Estimated Burden for Other Payer Advanced APM Identification
                 Determinations: Payer-Initiated Process
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Number of other payer payment arrangements (15 Medicaid,             165
 100 Medicare Advantage Organizations, 50 Multi-payers)
 (a)....................................................
Total Annual Hours Per other payer payment arrangement                10
 (b)....................................................
                                                         ---------------
    Total Annual Hours (c) = (a) * (b)..................           1,650
Labor rate for a computer systems analyst (d)...........       $89.18/hr
                                                         ---------------
    Total Annual Cost for Other Payer Advanced APM              $147,147
     determinations (e) = (a) * (d).....................
------------------------------------------------------------------------

    Eligible Clinician Initiated Process (Sec.  414.1445): This rule 
does not propose any new or revised reporting, recordkeeping, or third-
party disclosure requirements related to the Eligible Clinician 
Initiated Process. However, we are proposing adjustments to our 
currently approved burden estimates based on more recent data. The 
adjusted burden will be submitted to OMB for approval under control 
number 0938-1314 (CMS-10621).
    Beginning in Quality Payment Program Year 3, the All-Payer 
Combination Option will be an available pathway to QP status for 
eligible clinicians participating sufficiently in Advanced APMs and 
Other Payer Advanced APMs. The All-Payer Combination Option allows for 
eligible clinicians to achieve QP status through their participation in 
both Advanced APMs and Other Payer Advanced APMs. In order to include 
an eligible clinician's participation in Other Payer Advanced APMs in 
their QP threshold score, we will need to determine if certain payment 
arrangements with other payers meet the criteria to be Other Payer 
Advanced APMs.
    To provide eligible clinicians with advance notice prior to the 
start of a given performance period, and to allow other payers to be 
involved prospectively in the process, the CY 2018 Quality Payment 
Program final rule provided a payer-initiated identification process 
for identifying payment arrangements that qualify as Other Payer 
Advanced APMs (82 FR 53854). In the same rule, under the Eligible 
Clinician Initiated Process, APM Entities and eligible clinicians 
participating in other payer arrangements would have an opportunity to 
request that we determine for the year whether those other payer 
arrangements are Other Payer Advanced APMs (82 FR 53857-53858). 
However, to appropriately implement the statutory requirement to 
exclude from the All Payer Combination Option QP threshold calculations 
certain Title XIX payments and patients, we determined it would be 
problematic to allow APM Entities and eligible clinicians to request 
determinations for Title XIX payment arrangements after the conclusion 
of the QP performance period because any late-identified Medicaid APM 
or Medicaid Medical Home Model that meets the Other Payer Advanced APM 
criteria could unexpectedly affect QP threshold calculations for every 
other clinician in that state (or county). Thus, the CY 2018 Quality 
Payment Program final rule provided that APM Entities and eligible 
clinicians may request determinations for any Medicaid payment 
arrangements in which they are participating at an earlier point, prior 
to the start of a given QP performance period (82 FR 53858). This would 
allow all clinicians in a given state or county to know before the 
beginning of the performance period whether their Title XIX payments 
and patients would be excluded from the all-payer calculations that are 
used for QP determinations for the year under the All-Payer Combination 
Option. This Medicaid specific eligible clinician-initiated 
determination process for Other Payer Advanced APMs also began in CY 
2018, and determinations made in 2018 are applicable for the Quality 
Payment Program Year 3. Eligible clinicians or APM Entities seeking 
submit payment arrangement information for Other Payer Advanced APM 
determination through the Eligible Clinician-Initiated process are 
required to complete an Eligible Clinician Initiated Submission Form, 
instructions for which can be found at https://qpp.cms.gov/.
    As shown in Table 86, we estimate that 150 other payer arrangements 
will be submitted by APM Entities and eligible Other Payer Advanced APM 
determinations, an increase of 75 from the 75 total requests currently 
approved by OMB under the aforementioned control number.
    We estimate it would take 10 hours at $89.18/hr for a computer 
system analyst per arrangement submission. In aggregate we estimate an 
annual burden of 1,500 hours (150 submissions x 10 hr/submission) at a 
cost of $133,770 (1,500 hr x $89.18/hr). The increase in the number of 
clinician-initiated requests results in an adjustment of 750 hours and 
$66,885 (75 requests x 10 hr x $89.18/hr).

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

[[Page 36038]]

 
    Estimated Total Annual Cost for Other Payer Advanced        $133,770
     APM determinations (e) = (a) * (d).................
------------------------------------------------------------------------

    Submission of Data for QP Determinations under the All-Payer 
Combination Option (Sec.  414.1440): The following reflects the burden 
associated with the first year of data collection resulting from 
policies set out in the CY 2018 Quality Payment Program final rule. 
Because no collection of data was required prior to the CY 2019 
performance period, the requirements and burden were not submitted to 
OMB for approval. However, by virtue of this proposed rulemaking the 
requirements and burden will be submitted to OMB for approval under 
control number 0938-1314 (CMS-10621).
    The CY 2017 Quality Payment Program final rule, provided that 
either APM Entities or individual eligible clinicians must submit by a 
date and in a manner determined by us: (1) Payment arrangement 
information necessary to assess whether each other payer arrangement is 
an Other Payer Advanced APM, including information on financial risk 
arrangements, use of CEHRT, and payment tied to quality measures; (2) 
for each payment arrangement, the amounts of payments for services 
furnished through the arrangement, the total payments from the payer, 
the numbers of patients furnished any service through the arrangement 
(that is, patients for whom the eligible clinician is at risk if actual 
expenditures exceed expected expenditures), and (3) the total number of 
patients furnished any service through the arrangement (81 FR 77480). 
The rule also specified that if we do not receive sufficient 
information to complete our evaluation of another payer arrangement and 
to make QP determinations for an eligible clinician using the All-Payer 
Combination Option, we would not assess the eligible clinicians under 
the All-Payer Combination Option (81 FR 77480).
    In the CY 2018 Quality Payment Program final rule, we explained 
that in order for us to make QP determinations under the All-Payer 
Combination Option using either the payment amount or patient count 
method, we would need to receive all of the payment amount and patient 
count information: (1) Attributable to the eligible clinician or APM 
Entity through every Other Payer Advanced APM; and (2) for all other 
payments or patients, except from excluded payers, made or attributed 
to the eligible clinician during the QP performance period (82 FR 
53885). We also finalized that eligible clinicians and APM Entities 
will not need to submit Medicare payment or patient information for QP 
determinations under the All-Payer Combination Option (82 FR 53885).
    The CY 2018 Quality Payment Program final rule noted that we will 
need this payment amount and patient count information for the periods 
January 1 through March 31, January 1 through June 30, and January 1 
through August 31 (82 FR 53885). We noted that the timing may be 
challenging for APM Entities or eligible clinicians to submit 
information for the August 31 snapshot date. If we receive information 
for either the March 31 or June 30 snapshots, but not the August 31 
snapshot, we will use that information to make QP determinations under 
the All-Payer Combination Option. This payment amount and patient count 
information is to be submitted in a way that allows us to distinguish 
information from January 1 through March 31, January 1 through June 30, 
and January 1 through August 31 so that we can make QP determinations 
based on the two proposed snapshot dates (82 FR 30203 through 30204).
    The CY 2018 Quality Payment Program final rule specified that APM 
Entities or eligible clinicians must submit all of the required 
information about the Other Payer Advanced APMs in which they 
participate, including those for which there is a pending request for 
an Other Payer Advanced APM determination, as well as the payment 
amount and patient count information sufficient for us to make QP 
determinations by December 1 of the calendar year that is 2 years prior 
to the payment year, which we refer to as the QP Determination 
Submission Deadline (82 FR 53886).
    In section III.H.4.g.(4)(b) of this rule, we are proposing to add a 
third alternative to allow QP determinations at the TIN level in 
instances where all clinicians who have reassigned billing rights to 
the TIN participate in a single APM Entity. This option would therefore 
be available to all TINs participating in Full TIN APMs, such as the 
Medicare Shared Savings Program. It would also be available to any 
other TIN for which all clinicians who have reassigned billing rights 
to the TIN are participating in a single APM Entity. To make QP 
determinations under the All-Payer Combination Option at the TIN level 
as proposed using either the payment amount or patient count method, we 
would need to receive, by December 1 of the calendar year that is 2 
years prior to the payment year, all of the payment amount and patient 
count information: (1) Attributable to the eligible clinician, TIN, or 
APM Entity through every Other Payer Advanced APM; and (2) for all 
other payments or patients, except from excluded payers, made or 
attributed to the eligible clinician(s) during the QP performance 
period for the periods January 1 through March 31, January 1 through 
June 30, and January 1 through August 31 sufficient for us to make QP 
determinations.
    As shown in Table 87, we assume that 4 APM Entities, 8 TINs, and 80 
eligible clinicians will submit data for QP determinations under the 
All-Payer Combination Option in 2019. We estimate it will take the APM 
Entity representative, TIN representative, or eligible clinician 5 
hours at $107.38/hr for a practice administrator to complete this 
submission. In aggregate, we estimate an annual burden of 460 hours (92 
respondents x 5 hr) at a cost of $49,395 (460 hr x $107.38/hr).

 Table 87--Estimated Burden for the Submission of Data for All-Payer QP
                             Determinations
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Number of APM Entities submitting data for All-Payer QP                4
 Determinations (a).....................................

[[Page 36039]]

 
Number of TINs submitting data for All-Payer QP                        8
 Determinations (b).....................................
Number of eligible submitting data for All-Payer QP                   80
 Determinations (c).....................................
Hours Per respondent QP Determinations (d)..............               5
                                                         ---------------
    Total Hours (g) = [(a) * (d)] + [(b) * (d)] + [(c) *             460
     (d)]...............................................
Labor rate for a Practice Administrator ($107.38) (h)...      $107.38/hr
                                                         ---------------
    Total Annual Cost for Submission of Data for All-            $49,395
     Payer QP Determinations (i) = (g) * (h)............
------------------------------------------------------------------------

18. Quality Payment Program ICRs Regarding Voluntary Participants 
Election To Opt-Out of Performance Data Display on Physician Compare 
(Sec.  414.1395)
    The proposed requirements and burden associated with this data 
submission will be submitted to OMB for approval under control number 
0938-1314 (CMS-10621).
    We estimate that 10 percent of the total clinicians and groups who 
will voluntarily participate in MIPS will also elect not to participate 
in public reporting. This results in a total of 10,433 (10 percent x 
104,326 voluntary MIPS participants), a decrease of 11,967 from the 
total respondents currently approved by OMB under the aforementioned 
control number due to the reduction in voluntary participation in MIPS 
overall. As we discussed earlier in this section, voluntary respondents 
are the clinicians that submitted data to PQRS, are not QPs, and are 
expected to be excluded from MIPS after applying the eligibility 
requirements discussed in section III.H.3.a. of this rule. In 
implementing the proposed opt-in policy, we estimated that 33 percent 
of clincians that exceed 1 of the low-volume critieria, but not all 3, 
would elect to opt-in to MIPS, become MIPS eligible, and no longer be 
considered a voluntary reporter. This logic was also applied in the 
regulatory impact analysis of this rule. Table 88 shows that for these 
voluntary participants, we estimate it would take 0.25 hours at $89.18/
hr for a computer system analyst to submit a request to opt-out. In 
aggregate we estimate an annual burden of 2,608.25 hours (10,433 
requests x 0.25 hr/request) at a cost of $232,604 (2,608.25 hr x 
$89.18/hr).
    The decrease in the number of respondents due to policies proposed 
in this rule results in a decrease of -2,991.75 hours (-11,967 
respondents x 0.25 hr) and -$266,804 (-2,991.75 hours x $89.18/hr).

 Table 88--Estimated Burden for Voluntary Participants To Elect Opt Out
            of Performance Data Display on Physician Compare
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Number of Voluntary Participants Opting Out of Physician          10,433
 Compare (a)............................................
Total Annual Hours Per Opt-out Requester (b)............            0.25
                                                         ---------------
    Total Annual Hours for Opt-out Requester (c) = (a) *        2,608.25
     (b)................................................
Labor rate for a computer systems analyst (d)...........       $89.18/hr
                                                         ---------------
    Total Annual Cost for Opt-out Requests (e) = (a) *          $232,604
     (d)................................................
------------------------------------------------------------------------

19. Summary of Annual Quality Payment Program Burden Estimates
    Table 89 summarizes this proposed rule's burden estimates for the 
Quality Payment Program. In order to understand the burden implications 
of the policies proposed in this rule, we have also estimated a 
baseline burden of continuing the policies and information collections 
set forth in the CY 2018 Quality Payment Program final rule into the 
2019 MIPS performance period. Our baseline burden estimates reflect the 
recent availability of data sources to more accurately reflect the 
number of the organizations exempt from the Promoting Interoperability 
performance category and to more accurately reflect the exclusion of 
QPs from all MIPS performance categories.

             Table 89--Summary of Proposed Quality Payment Program Burden Estimates and Requirements
----------------------------------------------------------------------------------------------------------------
                                                                          Currently
                                Currently     Proposed      Change in     approved      Proposed      Change in
         Requirement            approved     respondents   respondents  total burden  total burden  total burden
                               respondents                                  hours         hours         hours
----------------------------------------------------------------------------------------------------------------
                               ICRs Under OMB Control Number 0938-1314 (CMS-10621)
----------------------------------------------------------------------------------------------------------------
Sec.   414.1400 Registry               120           150            30         1,200           450          -750
 self-nomination *..........
Sec.   414.1400 QCDR self-             113           200            87         1,130         2,400         1,270
 nomination *...............
Sec.   414.1325 and 414.1335             0         3,741         3,741             0         3,741         3,741
 CMS Enterprise Portal User
 Account Registration.......
Sec.   414.1325 and 414.1335       278,039       274,702        -3,337     4,949,094     3,900,768    -1,048,326
 (Quality Performance
 Category) Claims Collection
 Type.......................
Sec.   414.1325 and 414.1335       107,217       107,056          -161       973,852       972,390        -1,462
 (Quality Performance
 Category) QCDR/MIPS CQM
 Collection Type............

[[Page 36040]]

 
Sec.   414.1325 and 414.1335        54,218        53,529          -689       487,962       428,232       -59,730
 (Quality Performance
 Category) eCQM Collection
 Type.......................
Sec.   414.1325 and 414.1335           296           286           -10        21,904      16,931.2      -4,972.8
 (Quality Performance
 Category) CMS Web Interface
 Submission Type............
Sec.   414.1325 and 414.1335            10            67            57            10         16.75          6.75
 (Quality Performance
 Category) Registration and
 Enrollment for CMS Web
 Interface..................
(Quality Performance                    40           140           100            20           630           610
 Category) Call for Quality
 Measures...................
Sec.   414.1375 (Promoting          40,645        87,211        46,566        20,323        21,803         1,480
 Interoperability
 Performance Category)
 Application for Promoting
 Interoperability
 Reweighting................
Sec.   414.1375 (Promoting         218,215        67,622      -150,593       654,645       180,325      -474,320
 Interoperability
 Performance Category) Data
 Submission.................
(Promoting Interoperability             40            47             7            20          23.5           3.5
 Performance Category) Call
 for Promoting
 Interoperability Measures..
Sec.   414.1360 (Improvement       439,786       392,938       -46,848       439,786      32,744.8    -407,041.2
 Activities Performance
 Category) Data Submission..
Sec.   414.1360 (Improvement           150           125           -25            75           250          -175
 Activities Performance
 Category) Nomination of
 Improvement Activities.....
Sec.   414.1430 Partial                 17            81            64          4.25         20.25            16
 Qualifying APM Participant
 (QP) Election..............
Sec.   414.1440 Other Payer            300           165          -135         3,000         1,650        -1,350
 Advanced APM
 Identification: Payer
 Initiated Process..........
Sec.   414.1445 Other Payer             75           150            75           750         1,500           750
 Advanced APM
 Identification: Eligible
 Clinician Initiated Process
Sec.   414.1440 Submission               0            92            92             0           460           460
 of Data for All-Payer QP
 Determinations under the
 All-Payer Combination
 Option.....................
Sec.   414.1395 (Physician          22,400        10,433       -11,967         5,600      2,608.25     -2,991.75
 Compare) Opt Out for
 Voluntary Participants.....
                             -----------------------------------------------------------------------------------
    Subtotal................     1,161,681       998,735      -162,946     7,559,375     5,566,944    -1,992,782
----------------------------------------------------------------------------------------------------------------
                               ICRs Under OMB Control Number 0938-1222 (CMS-10450)
----------------------------------------------------------------------------------------------------------------
Sec.   414.1325 and 414.1335       132,307        65,793       -66,514        29,108        14,145       -14,963
 (CAHPS for MIPS Survey)
 Beneficiary Participation..
Sec.   414.1325 and 414.1335           461           454            -7         691.5         340.5          -351
 (CAHPS for MIPS Survey)
 Group Registration.........
                             -----------------------------------------------------------------------------------
    Subtotal................       132,768        66,247       -66,521        29,800      14,485.5       -15,314
                             -----------------------------------------------------------------------------------
        Total...............     1,294,449     1,064,982      -229,467     7,589,175     5,581,429    -2,008,096
----------------------------------------------------------------------------------------------------------------
* These two ICRs were combined in a single ICR in the CY 2018 Quality Payment Program final rule (82 FR 53906
  through 53907).

    Table 90 provides the reasons for changes in the estimated burden 
for information collections in this proposed rule. We have divided the 
reasons for our change in burden into those related to new policies and 
those related to changes in the baseline burden of continued Quality 
Payment Program Year 2 policies that reflect updated data and methods.

    Table 90--Reasons for Change in Burden Compared to the Currently
             Approved CY 2018 Information Collection Burdens
------------------------------------------------------------------------
                                                         Changes to
                                                      ``baseline'' of
                                Changes in burden  burden continued Year
    Table in collection of       due to finalized  2 policy (italics are
          information            Year 3 policies    changes in number of
                                                    respondents' due to
                                                       updated data)
------------------------------------------------------------------------
Table 63: Qualified Registry    None.............  After a review of the
 Self-Nomination.                                   self-nomination
                                                    process, we
                                                    determined it is
                                                    more accurate to
                                                    separately assess
                                                    the burden of
                                                    Qualified Registry
                                                    and QCDR self-
                                                    nomination rather
                                                    than aggregate them
                                                    in the same ICR.
                                                   Review of self-
                                                    nomination process
                                                    resulted in a
                                                    decrease in
                                                    estimated time
                                                    needed to complete
                                                    simplified self-
                                                    nomination (-9.5 hr.
                                                    computer system
                                                    analyst time) and
                                                    full self-nomination
                                                    (-7 hr. computer
                                                    system analyst
                                                    time).
                                                   Increase in the
                                                    number of
                                                    respondents as the
                                                    number of qualified
                                                    registries enrolling
                                                    increases and the
                                                    basis for estimating
                                                    the number of
                                                    respondents is
                                                    updated to reflect
                                                    the number of self-
                                                    nomination
                                                    applications
                                                    received in place of
                                                    the number of
                                                    qualified registries
                                                    being approved.
Table 64: QCDR Self-Nomination  None.............  After a review of the
                                                    self-nomination
                                                    process, we
                                                    determined it is
                                                    more accurate to
                                                    separately assess
                                                    the burden of
                                                    Qualified Registry
                                                    and QCDR self-
                                                    nomination rather
                                                    than aggregate them
                                                    in the same ICR.
                                                   Review of self-
                                                    nomination process
                                                    resulted in an
                                                    increase in
                                                    estimated time
                                                    needed to complete
                                                    simplified self-
                                                    nomination (-0.5 hr.
                                                    computer system
                                                    analyst time) and
                                                    full self-nomination
                                                    (+2 hr. computer
                                                    system analyst
                                                    time).
                                                   Increase in the
                                                    number of
                                                    respondents as the
                                                    number of QCDRs
                                                    enrolling increases
                                                    and the basis for
                                                    estimating the
                                                    number of
                                                    respondents is
                                                    updated to reflect
                                                    the number of self-
                                                    nomination
                                                    applications
                                                    received in place of
                                                    the number of QCDRs
                                                    being approved.

[[Page 36041]]

 
Table 68: Quality Payment       None.............  Decreased number of
 Program Identity Management                        respondents due to
 Application Process.                               updates to the
                                                    identity management
                                                    system being used
                                                    for data submission;
                                                    only new respondents
                                                    submitting quality
                                                    data using the CMS
                                                    Enterprise Portal
                                                    need to create a new
                                                    account, versus
                                                    system where all
                                                    respondents
                                                    submitting via EHR
                                                    needed to register
                                                    for user account
                                                    annually.
Table 69: Quality Performance   None.............  Decreased number of
 Category Claims Collection                         respondents due to
 Type.                                              increase in the
                                                    number of QPs
                                                    excluded from
                                                    submitting data.
                                                   Correction to
                                                    estimate to account
                                                    for reduced number
                                                    of required measures
                                                    compared to PQRS (6
                                                    in MIPS; 9 in PQRS)
                                                    reduced estimated
                                                    time to submit data.
Table 70: Quality Performance   None.............  Decreased number of
 Category QCDR/MIPS CQM                             respondents due to
 Collection Type.                                   increase in the
                                                    number of QPs
                                                    excluded from
                                                    submitting data.
Table 71: Quality Performance   None.............  Decreased number of
 Category eCQM Collection Type.                     respondents due to
                                                    increase in the
                                                    number of QPs
                                                    excluded from
                                                    submitting data.
Table 72: Quality Performance   Decrease in        Decrease in the
 Category CMS Web Interface.     number of          number of
                                 required           respondents as fewer
                                 measures           eligible group
                                 resulted in        practices elected to
                                 reduction in       submit data using
                                 estimated time     the CMS Web
                                 needed to submit   Interface.
                                 data (-14.8 hrs
                                 computer system
                                 analyst time).
Table 73: Beneficiary           None.............  Decrease in the
 Responses to CAHPS for MIPS                        number of
 Survey.                                            respondents as fewer
                                                    eligible group
                                                    practices elect to
                                                    have vendors
                                                    administer the CAHPS
                                                    for MIPS survey and
                                                    fewer beneficiaries
                                                    per group respond to
                                                    the survey, on
                                                    average.
Table 74: Registration for CMS  None.............  Increase in the
 Web Interface.                                     number of
                                                    respondents as more
                                                    groups register to
                                                    submit data using
                                                    the CMS Web
                                                    Interface.
                                                   Review of
                                                    registration process
                                                    resulted in decrease
                                                    in estimated time to
                                                    register. (-0.75 hr.
                                                    computer system
                                                    analyst time).
Table 75: Registration for      None.............  Decrease in the
 CAHPS for MIPS Survey.                             number of
                                                    respondents as fewer
                                                    eligible group
                                                    practices elect to
                                                    have vendors
                                                    administer the CAHPS
                                                    for MIPS survey.
                                                   Review of
                                                    registration process
                                                    resulted in decrease
                                                    in estimated time to
                                                    register. (-0.75 hr.
                                                    computer system
                                                    analyst time).
Table 76: Call for Quality      None.............  Increase in the
 Measures.                                          number of new
                                                    quality measures
                                                    being nominated.
                                                   Inclusion of time
                                                    required to complete
                                                    Peer Review Journal
                                                    Article Form
                                                    resulted in increase
                                                    in time to nominate
                                                    a quality measure.
                                                    This was a
                                                    requirement in the
                                                    CY 2017 Quality
                                                    Payment Program
                                                    final rule (81 FR
                                                    77153 through
                                                    77155), but was not
                                                    included in burden
                                                    estimates. (+4 hrs
                                                    Physician time).
Table 77: Application for       None.............  Increase in the
 Promoting Interoperability                         number of
 Reweighting.                                       respondents as the
                                                    estimated number of
                                                    APM Entities with
                                                    hardship approval
                                                    was previously not
                                                    included.
                                                   Review of application
                                                    process resulted in
                                                    decrease in
                                                    estimated time to
                                                    apply (-0.25 hr
                                                    computer system
                                                    analyst time).
Table 79: Promoting             Decrease in        Decrease in the
 Interoperability Performance    number of          number of
 Category Data Submission.       required           respondents due to
                                 measures           increase in the
                                 resulted in        estimate of hospital-
                                 reduction in       based clinicians and
                                 estimated time     clinicians in small
                                 needed to submit   practices, more
                                 data (-.33 hr      accurate estimate of
                                 computer system    the number of TINs
                                 analyst time).     submitting data for
                                                    MIPS APMs, and
                                                    accounting for
                                                    individuals which
                                                    may have submitted
                                                    quality data via two
                                                    or more submission
                                                    or collection types.
Table 80: Call for Promoting    None.............  Increase in the
 Interoperability Measures.                         number of new
                                                    Promoting
                                                    Interoperability
                                                    measures being
                                                    nominated.
Table 82: Improvement           None.............  Decreased number of
 Activities Submission.                             respondents due to
                                                    increase in the
                                                    number of QPs
                                                    excluded from
                                                    submitting data and
                                                    accounting for
                                                    individuals which
                                                    may have submitted
                                                    quality data via two
                                                    or more submission
                                                    or collection types.
                                                   Review of submission
                                                    process resulted in
                                                    decrease in
                                                    estimated to submit
                                                    (-0.92 hr computer
                                                    system analyst
                                                    time).
Table 83: Nomination of         None.............  Review of nomination
 Improvement Activities.                            process resulted in
                                                    increase in
                                                    estimated time to
                                                    nominate a new
                                                    improvement activity
                                                    (+0.9 hrs Practice
                                                    Administrator time;
                                                    +0.6 hrs Physician
                                                    time).
Table 84: Partial QP Election.  None.............
Table 85: Other Payer Advanced  None.............  Decrease in the
 APM Identification: Other                          number of
 Payer Initiated Process.                           anticipated other
                                                    payer arrangements
                                                    submitted for
                                                    identification as
                                                    Other Payer Advanced
                                                    APMs.
Table 86: Other Payer Advanced  None.............  Increase in the
 APM Identification: Eligible                       number of
 Clinician Initiated Process.                       anticipated other
                                                    payer arrangements
                                                    submitted by APM
                                                    Entities and
                                                    eligible clinicians
                                                    for identification
                                                    as Other Payer
                                                    Advanced APMs.
Table 87: Submission of Data    Reflects new       None.
 for All-Payer QP                policy in this
 Determinations under the All-   proposed rule.
 Payer Combination Option.
Table 88: Voluntary             Decrease in the    None.
 Participants to Elect to Opt    number of
 Out of Performance Data         respondents as a
 Display on Physician Compare.   result of fewer
                                 individuals and
                                 groups being
                                 excluded from
                                 MIPS eligibility.
------------------------------------------------------------------------

C. Summary of Annual Burden Estimates for Proposed Requirements

[[Page 36042]]



                                                        Table 91--Annual Requirements and Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                    Total annual
Regulation section(s) under Title   OMB control   Respondents    Responses    Burden per  response      burden        Labor cost  of     Total cost  ($)
          42 of the CFR               No. ***                                       (hours)            (hours)      reporting  ($/hr)           *
--------------------------------------------------------------------------------------------------------------------------------------------------------
414.94(j) (AUC consultations)....     0938-1345       586,386    43,181,818  0.033 (2 min)........     1,425,000  varies...............      119,275,350
Quality Payment Program (See          0938-1314          (**)     (162,946)  varies...............   (1,992,782)  varies...............    (177,891,746)
 Subtotal Under Table 89).
Quality Payment Program (See          0938-1222      (66,521)      (66,521)  varies...............      (15,314)  varies...............        (394,855)
 Subtotal Under Table 89).
                                  ----------------------------------------------------------------------------------------------------------------------
    Total........................  ............     1,187,338    42,952,351  varies...............     (583,096)  varies...............     (59,011,251)
--------------------------------------------------------------------------------------------------------------------------------------------------------
* With respect to the PRA, this rule would not impose any non-labor costs.
** We are unable to accurately calculate a total number of respondents for the Quality Payment Program. In many cases, individuals, groups, and entities
  have responded to multiple data collections and there is no unified way to identify unique respondents.
*** OMB and CMS' PRA package ID numbers: OMB 0938-1345 (CMS-10654), OMB 0938-1314 (CMS-10621), and OMB 0938-1222 (CMS-10450). 0938-1222 (CMS-10450).

D. Submission of PRA-Related Comments

    We have submitted a copy of this rule's information collection and 
recordkeeping requirements to OMB for review and approval. These 
requirements are not effective until they have been approved by the 
OMB.
    To obtain copies of the supporting statement and any related forms 
for the proposed collections discussed above, please visit CMS's 
website at www.cms.hhs.gov/PaperworkReductionActof1995, or call the 
Reports Clearance Office at 410-786-1326.
    We invite public comments on these potential information collection 
requirements. If you wish to comment, please refer to the DATES and 
ADDRESSES sections of this rulemaking for instructions. We will 
consider all ICR-related comments received by the date and time 
specified in the DATES section, and, when we proceed with a subsequent 
document, we will respond to the comments in the preamble to that 
document.

VI. Response to Comments

    Because of the large number of public comments we normally receive 
on Federal Register documents, we are not able to acknowledge or 
respond to them individually. We will consider all comments we receive 
by the date and time specified in the DATES section of this preamble, 
and, when we proceed with a subsequent document, we will respond to the 
comments in the preamble to that document.

VII. Regulatory Impact Analysis

A. Statement of Need

    This proposed rule makes payment and policy changes under the 
Medicare PFS and implements required statutory changes under the 
Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), the 
Achieving a Better Life Experience Act (ABLE), the Protecting Access to 
Medicare Act of 2014 (PAMA), section 603 of the Bipartisan Budget Act 
of 2015, the Consolidated Appropriations Act of 2016, and the 
Bipartisan Budget Act of 2018. This proposed rule also makes changes to 
payment policy and other related policies for Medicare Part B, Part D, 
and Medicare Advantage.
    In addition, section 218(b) of the PAMA added section 1834(q) of 
the Act directing the Secretary to establish a program to promote the 
use of AUC. Section 1834(q)(4) of the Act requires ordering 
professionals to consult with specified applicable AUC through a 
qualified CDSM for applicable imaging services furnished in an 
applicable setting and paid for under an applicable payment system, and 
for the furnishing professional or facility to include on the Medicare 
claim information about the ordering professional's consultation with 
specified applicable AUC through a qualified CDSM. This proposed rule 
is necessary to make policy changes under Medicare fee-for-service. 
Therefore, we include a detailed regulatory impact analysis to assess 
all costs and benefits of available regulatory alternatives and 
explained the selection of these regulatory approaches that we believe 
adhere to section 1834(q) of the Act and, to the extent feasible, 
maximize net benefits.
    This proposed rule also makes payment and policy changes under the 
Medicare Physician Fee Schedule and makes required statutory changes 
under the MACRA, as amended by section 51003 of the Bipartisan Budget 
Act of 2018.
    Proposed new policies for CY 2019 are detailed throughout this 
proposed rule. For example, the proposals associated with modernizing 
Medicare physician payment by recognizing communication technology-
based services are described in section II.D. of this proposed rule, 
while the proposals associated with E/M visits are described in section 
II.I. of this proposed rule. Several proposals using innovative 
technology that enables remote services would expand access to care and 
create more opportunities for patients to access more personalized care 
management as well as connect with their physicians more quickly. These 
proposals would support access to care using telecommunications 
technology by: Paying clinicians for virtual check-ins--brief, non-
face-to-face appointments via communications technology; paying 
clinicians for evaluation of patient-submitted photos; and expanding 
Medicare-covered telehealth services to include prolonged preventive 
services.
    Several provisions in the proposed rule would also help to free 
electronic health records to be powerful tools to support efficient 
care while giving physicians more time to spend with their patients, 
especially those with complex needs, rather than on paperwork. 
Specifically, the E/M proposal would: Simplify, streamline, and offer 
flexibility in documentation and coding requirements for E/M visits, 
which make up about 40 percent of allowed charges under the PFS and 
consume much of clinicians' time; reduce unnecessary physician 
supervision of radiologist assistants during diagnostic services; and 
remove burdensome and overly complex functional reporting requirements 
for outpatient therapy. In addition, Section VII.H. of this Regulatory 
Impact Analysis details the economic effect of these proposed policies 
on Medicare providers and beneficiaries.

B. Overall Impact

    We examined the impact of this rule as required by Executive Order 
12866 on Regulatory Planning and Review (September 30, 1993), Executive 
Order 13563 on Improving Regulation and Regulatory Review (February 2, 
2013), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. 
L. 96-354), section 1102(b) of the Social Security Act, section 202 of 
the Unfunded Mandates Reform Act of 1995 (March

[[Page 36043]]

22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 
4, 1999), the Congressional Review Act (5 U.S.C. 804(2)), and Executive 
Order 13771 on Reducing Regulation and Controlling Regulatory Costs 
(January 30, 2017).
    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). A 
regulatory impact analysis (RIA) must be prepared for major rules with 
economically significant effects ($100 million or more in any 1 year). 
We estimate, as discussed in this section, that the PFS provisions 
included in this proposed rule would redistribute more than $100 
million in 1 year. Therefore, we estimate that this rulemaking is 
``economically significant'' as measured by the $100 million threshold, 
and hence also a major rule under the Congressional Review Act. 
Accordingly, we prepared an RIA that, to the best of our ability, 
presents the costs and benefits of the rulemaking. The RFA requires 
agencies to analyze options for regulatory relief of small entities. 
For purposes of the RFA, small entities include small businesses, 
nonprofit organizations, and small governmental jurisdictions. Most 
hospitals, practitioners and most other providers and suppliers are 
small entities, either by nonprofit status or by having annual revenues 
that qualify for small business status under the Small Business 
Administration standards. (For details see the SBA's website at https://www.sba.gov/content/table-small-business-size-standards (refer to the 
620000 series)). Individuals and states are not included in the 
definition of a small entity.
    The RFA requires that we analyze regulatory options for small 
businesses and other entities. We prepare a regulatory flexibility 
analysis unless we certify that a rule would not have a significant 
economic impact on a substantial number of small entities. The analysis 
must include a justification concerning the reason action is being 
taken, the kinds and number of small entities the rule affects, and an 
explanation of any meaningful options that achieve the objectives with 
less significant adverse economic impact on the small entities.
    Approximately 95 percent of practitioners, other providers, and 
suppliers are considered to be small entities, based upon the SBA 
standards. There are over 1 million physicians, other practitioners, 
and medical suppliers that receive Medicare payment under the PFS. 
Because many of the affected entities are small entities, the analysis 
and discussion provided in this section, as well as elsewhere in this 
proposed rule is intended to comply with the RFA requirements regarding 
significant impact on a substantial number of small entities.
    For example, the effects of changes to payment rates for 
practitioners, other providers, and suppliers are discussed in VII.C. 
of this proposed rule. Alternative options considered to the proposed 
payment rates are discussed generally in section VII.F of this proposed 
rule, while specific alternatives for individual codes are discussed 
throughout this rule, especially in section II.H.
    In addition, section 1102(b) of the Act requires us to prepare an 
RIA if a rule may have a significant impact on the operations of a 
substantial number of small rural hospitals. This analysis must conform 
to the provisions of section 604 of the RFA. For purposes of section 
1102(b) of the Act, we define a small rural hospital as a hospital that 
is located outside of a Metropolitan Statistical Area for Medicare 
payment regulations and has fewer than 100 beds. The PFS does not 
reimburse for services provided by rural hospitals; the PFS pays for 
physicians' services, which can be furnished by physicians and non-
physician practitioners in a variety of settings, including rural 
hospitals. We did not prepare an analysis for section 1102(b) of the 
Act because we determined, and the Secretary certified, that this 
proposed rule would not have a significant impact on the operations of 
a substantial number of small rural hospitals.
    Section 202 of the Unfunded Mandates Reform Act of 1995 also 
requires that agencies assess anticipated costs and benefits on state, 
local, or tribal governments or on the private sector before issuing 
any rule whose mandates require spending in any 1 year of $100 million 
in 1995 dollars, updated annually for inflation. In 2018, that 
threshold is approximately $150 million. This proposed rule will impose 
no mandates on state, local, or tribal governments or on the private 
sector.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it issues a proposed rule (and subsequent final 
rule) that imposes substantial direct requirement costs on state and 
local governments, preempts state law, or otherwise has Federalism 
implications. Since this regulation does not impose any costs on state 
or local governments, the requirements of Executive Order 13132 are not 
applicable.
    Executive Order 13771, entitled Reducing Regulation and Controlling 
Regulatory Costs (82 FR 9339), was issued on January 30, 2017. This 
proposed rule is considered an E.O. 13771 regulatory action because it 
is expected to result in regulatory costs. The estimated impact would 
be $5 million in costs in 2019, $4.114 billion in costs in 2020, and 
$44 million in cost savings in 2021 and thereafter. Annualizing these 
costs and cost savings in perpetuity and discounting at 7 percent back 
to 2016, we estimate that this rule would generate $174 million in 
annualized net costs for E.O. 13771 accounting purposes. Details on the 
estimated costs of this rule can be found in the following analyses.
    We prepared the following analysis, which together with the 
information provided in the rest of this preamble, meets all assessment 
requirements. The analysis explains the rationale for and purposes of 
this proposed rule; details the costs and benefits of the rule; 
analyzes alternatives; and presents the measures we would use to 
minimize the burden on small entities. As indicated elsewhere in this 
proposed rule, we are implementing a variety of changes to our 
regulations, payments, or payment policies to ensure that our payment 
systems reflect changes in medical practice and the relative value of 
services, and implementing statutory provisions. We provide information 
for each of the policy changes in the relevant sections of this 
proposed rule. We are unaware of any relevant federal rules that 
duplicate, overlap, or conflict with this proposed rule. The relevant 
sections of this proposed rule contain a description of significant 
alternatives if applicable.

C. Changes in Relative Value Unit (RVU) Impacts

1. Resource-Based Work, PE, and MP RVUs
    Section 1848(c)(2)(B)(ii)(II) of the Act requires that increases or 
decreases in RVUs may not cause the amount of expenditures for the year 
to differ by more than $20 million from what expenditures would have 
been in the absence of these changes. If this threshold is exceeded, we 
make adjustments to preserve budget neutrality.
    Our estimates of changes in Medicare expenditures for PFS services 
compare payment rates for CY 2018 with payment rates for CY 2019 using 
CY 2017 Medicare utilization. The payment

[[Page 36044]]

impacts in this proposed rule reflect averages by specialty based on 
Medicare utilization. The payment impact for an individual practitioner 
could vary from the average and would depend on the mix of services he 
or she furnishes. The average percentage change in total revenues would 
be less than the impact displayed here because practitioners and other 
entities generally furnish services to both Medicare and non-Medicare 
patients. In addition, practitioners and other entities may receive 
substantial Medicare revenues for services under other Medicare payment 
systems. For instance, independent laboratories receive approximately 
83 percent of their Medicare revenues from clinical laboratory services 
that are paid under the Clinical Laboratory Fee Schedule.
    The annual update to the PFS conversion factor (CF) was previously 
calculated based on a statutory formula; for details about this 
formula, we refer readers to the CY 2015 PFS final rule with comment 
period (79 FR 67741 through 67742). Section 101(a) of the MACRA 
repealed the previous statutory update formula and amended section 
1848(d) of the Act to specify the update adjustment factors for 
calendar years 2015 and beyond. The update adjustment factor for CY 
2019, as required by section 53106 of the Bipartisan Budget Act of 
2018, is 0.25 percent before applying other adjustments.
    To calculate the proposed conversion factor for this year, we 
multiplied the product of the current year conversion factor and the 
update adjustment factor by the budget neutrality adjustment described 
in the preceding paragraphs. We estimate the CY 2019 PFS conversion 
factor to be 36.0463, which reflects the budget neutrality adjustment 
under section 1848(c)(2)(B)(ii)(II) and the 0.25 percent update 
adjustment factor specified under section 1848(d)(18) of the Act. We 
estimate the CY 2019 anesthesia conversion factor to be 22.2986, which 
reflects the same overall PFS adjustments with the addition of 
anesthesia-specific PE and MP adjustments.

   Table 92--Calculation of the Proposed CY 2019 PFS Conversion Factor
------------------------------------------------------------------------
 
------------------------------------------------------------------------
CY 2018 Conversion Factor.........  ....................         35.9996
    Statutory Update Factor.......  0.25 percent          ..............
                                     (1.0025).
    CY 2019 RVU Budget Neutrality   -0.12 percent         ..............
     Adjustment.                     (0.9988).
CY 2019 Conversion Factor.........  ....................         36.0463
------------------------------------------------------------------------


   Table 93--Calculation of the Proposed CY 2019 Anesthesia Conversion
                                 Factor
------------------------------------------------------------------------
 
------------------------------------------------------------------------
CY 2018 National Average            ....................         22.1887
 Anesthesia.
Conversion Factor.................
    Statutory Update Factor.......  0.25 percent          ..............
                                     (1.0025).
    CY 2019 RVU Budget Neutrality   -0.12 percent         ..............
     Adjustment.                     (0.9988).
    CY 2019 Anesthesia Fee          0.365 percent         ..............
     Schedule Practice Expense and   (1.00365).
     Malpractice Adjustment.
CY 2019 Conversion Factor.........  ....................         22.2986
------------------------------------------------------------------------

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

                  Table 94--CY 2019 PFS Estimated Impact on Total Allowed Charges by Specialty
----------------------------------------------------------------------------------------------------------------
                                                     Impact of     Impact of  PE   Impact of  MP
            Specialty                 Allowed        work RVU      RVU  changes    RVU  changes      Combined
                                  charges  (mil)   changes  (%)         (%)             (%)        impact *  (%)
(A)                                          (B)             (C)             (D)             (E)             (F)
----------------------------------------------------------------------------------------------------------------
TOTAL...........................         $92,173               0               0               0               0
ALLERGY/IMMUNOLOGY..............             238               1              -6               0              -5

[[Page 36045]]

 
ANESTHESIOLOGY..................           1,889               0               0               0               0
AUDIOLOGIST.....................              67               0               0              -1              -1
CARDIAC SURGERY.................             293              -1              -1               1              -1
CARDIOLOGY......................           6,590               0              -1               0              -1
CHIROPRACTOR....................             749               0               1               0               0
CLINICAL PSYCHOLOGIST...........             770               0               2               0               2
CLINICAL SOCIAL WORKER..........             725               0               2               0               2
COLON AND RECTAL SURGERY........             165               0               1               0               1
CRITICAL CARE...................             340              -1               0               0               0
DERMATOLOGY.....................           3,477               1              -2               0              -1
DIAGNOSTIC TESTING FACILITY.....             728               0              -4               0              -4
EMERGENCY MEDICINE..............           3,110               0               0               0               0
ENDOCRINOLOGY...................             480               0              -1               0              -1
FAMILY PRACTICE.................           6,176               0               1               0               1
GASTROENTEROLOGY................           1,750              -1               1               0               1
GENERAL PRACTICE................             423               0               1               0               1
GENERAL SURGERY.................           2,079               0               0               0               1
GERIATRICS......................             196              -2               1               0              -1
HAND SURGERY....................             213               2               1               0               2
HEMATOLOGY/ONCOLOGY.............           1,737              -1              -3               0              -4
INDEPENDENT LABORATORY..........             640               0               4               0               4
INFECTIOUS DISEASE..............             645              -1               1               0               0
INTERNAL MEDICINE...............          10,698               0               1               0               1
INTERVENTIONAL PAIN MGMT........             863               2               1               0               3
INTERVENTIONAL RADIOLOGY........             384               1              -1               0               0
MULTISPECIALTY CLINIC/OTHER PHYS             148              -1               0               0              -1
NEPHROLOGY......................           2,182              -1               0               0              -1
NEUROLOGY.......................           1,521              -1              -1               0              -2
NEUROSURGERY....................             798               0               0               1               1
NUCLEAR MEDICINE................              50              -1              -1               0              -1
NURSE ANES/ANES ASST............           1,163               0               0               0               0
NURSE PRACTITIONER..............           4,043               1               2               0               2
OBSTETRICS/GYNECOLOGY...........             635               3               1               0               4
OPHTHALMOLOGY...................           5,437               0              -1               0              -1
OPTOMETRY.......................           1,301               1               0               0               1
ORAL/MAXILLOFACIAL SURGERY......              67               1              -2               0              -1
ORTHOPEDIC SURGERY..............           3,730               1               0               0               1
OTHER...........................              31               0               5               0               4
OTOLARNGOLOGY...................           1,206               2              -3               0              -1
PATHOLOGY.......................           1,158               0              -1               0              -1
PEDIATRICS......................              61              -1               0               0              -1
PHYSICAL MEDICINE...............           1,102              -1               0               0              -1
PHYSICAL/OCCUPATIONAL THERAPY...           3,930               0              -1               0              -1
PHYSICIAN ASSISTANT.............           2,447               1               0               0               1
PLASTIC SURGERY.................             373               1               0               0               1
PODIATRY........................           1,958              -1               0               0              -2
PORTABLE X-RAY SUPPLIER.........              98               0               1               0               1
PSYCHIATRY......................           1,177               0               2               0               3
PULMONARY DISEASE...............           1,709              -2               0               0              -2
RADIATION ONCOLOGY AND RADIATION           1,760               0              -2               0              -2
 THERAPY CENTERS................
RADIOLOGY.......................           4,891               0               0               0               0
RHEUMATOLOGY....................             540              -1              -3               0              -4
THORACIC SURGERY................             356              -1              -1               1              -1
UROLOGY.........................           1,733               2               1               0               3
VASCULAR SURGERY................           1,144               0              -2               0              -1
----------------------------------------------------------------------------------------------------------------
* Column F may not equal the sum of columns C, D, and E due to rounding.

2. CY 2019 PFS Impact Discussion
a. Changes in RVUs
    The most widespread specialty impacts of the proposed RVU changes 
are generally related to the changes to RVUs for specific services 
resulting from the Misvalued Code Initiative, including proposed RVUs 
for new and revised codes. Because office/outpatient E/M codes comprise 
a large volume of services in the PFS, much of the specialty level 
impacts are being driven by our proposal to establish a single payment 
rate for new patients and a single PFS rate for established patients 
for E/M visits levels 2-5 as well as other adjustments including: The 
E/M

[[Page 36046]]

Multiple Procedure Payment Adjustment, the HCPCS G-code add-ons to 
recognize additional relative resources for certain kinds of visits, 
HCPCS G-codes to describe podiatric E/M visits, the technical 
adjustment to the PE methodology, and the HCPCS G-code for 30 minutes 
of prolonged services. For specific information on these proposals, see 
II.I. of this proposed rule. The estimated impacts for some 
specialties, including obstetrics/gynecology, urology, independent 
labs, and clinical psychologists, reflect increases relative to other 
physician specialties. These increases can largely be attributed to 
proposed increases in value for particular services, the proposed 
updates to supply and equipment pricing, and the proposed valuation of 
the E/M office visit codes that had a positive impact on specialties 
reporting a higher proportion of level 2 and level 3 office visits.
    The estimated impacts for several specialties, including allergy/
immunology, diagnostic testing facilities, hematology/oncology, 
radiation therapy centers, and podiatry, reflect decreases in payments 
relative to payment to other physician specialties. Allergy/immunology 
experiences a decrease due to a reduction in PE RVUs based on updated 
supply pricing for certain codes frequently billed by this specialty. 
For the other specialties, these decreases can largely be attributed to 
proposed revaluation of individual procedures, proposed decreases in 
relative payment as a result of proposed updates to prices for medical 
supplies and equipment, and the continued implementation of previously 
finalized code-level reductions that are being phased-in over several 
years. For independent laboratories, it is important to note that these 
entities receive approximately 83 percent of their Medicare revenues 
from services that are paid under the Clinical Laboratory Fee Schedule. 
As a result, the estimated 1 percent reduction for CY 2019 is only 
applicable to approximately 17 percent of the Medicare payment to these 
entities.
    Additionally, specialties such as podiatry and dermatology that 
would experience a decrease in payments are those that bill a large 
portion of E/M visits on the same day as procedures, and therefore 
would see a reduction based on the application of the E/M MPPR 
adjustments. Other specialties, such as rheumatology and hematology/
oncology are estimated to experience a decrease in payments due to the 
E/M proposals because they may tend to bill greater proportion of level 
4 and 5 E/M visits and the add-on codes for inherent visit complexity 
may not fully mitigate a reduction in their payments. Specialties such 
as OB/GYN and urology would see an increase in payments from these 
proposals, due to a combination of single PFS rates for E/M visit 
levels and the add-on codes for inherent visit complexity. For a more 
thorough discussion of the specialty level impacts of these proposals, 
see section II.I. of this proposed rule.
    We often receive comments regarding the changes in RVUs displayed 
on the specialty impact table, including comments received in response 
to the proposed rates. We remind stakeholders that although the 
estimated impacts are displayed at the specialty level, typically the 
changes are driven by the valuation of a relatively small number of new 
and/or potentially misvalued codes. The percentages in the table are 
based upon aggregate estimated PFS allowed charges summed across all 
services furnished by physicians, practitioners, and suppliers within a 
specialty to arrive at the total allowed charges for the specialty, and 
compared to the same summed total from the previous calendar year. 
Therefore, they are averages, and may not necessarily be representative 
of what is happening to the particular services furnished by a single 
practitioner within any given specialty.
b. Impact
    Column F of Table 94 displays the estimated CY 2019 impact on total 
allowed charges, by specialty, of all the RVU changes. A table showing 
the estimated impact of all of the changes on total payments for 
selected high volume procedures is available under ``downloads'' on the 
CY 2019 PFS proposed rule website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/. We selected these 
procedures for sake of illustration from among the procedures most 
commonly furnished by a broad spectrum of specialties. The change in 
both facility rates and the nonfacility rates are shown. For an 
explanation of facility and nonfacility PE, we refer readers to 
Addendum A on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/.

D. Effect of Changes Related to Telehealth

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

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

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

F. Other Provisions of the Proposed Regulation

1. Part B Drugs: Application of an Add-On Percentage for Certain 
Wholesale Acquisition Cost (WAC)-Based Payments
    In section II.N. of this rule, we proposed that effective January 
1, 2019, WAC based payments for Part B drugs made under section 
1847A(c)(4) of the Act would utilize a 3 percent add-on in place of the 
6 percent add-on that is

[[Page 36047]]

currently being used. If this proposal is finalized, we would also 
permit MACs to use an add-on percentage of up to 3 percent for WAC-
based payments for new drugs.
    We anticipate that the proposed reduction to the add-on payment 
made for a subset of Part B drugs will result in savings to the 
Medicare program by bringing payment amounts for newly approved drugs 
closer to acquisition costs. The proposed 3 percent add-on is 
consistent with MedPAC's analysis and recommendations as well as 
discounts observed by MedPAC in their June 2017 Report to the Congress. 
We have also considered how CMS's experience with WAC-based pricing for 
recently marketed new drugs and biologicals compares to MedPAC's 
findings. Although the number of new drugs that are priced using WAC is 
very limited, the average difference between WAC and ASP-based payment 
limits for a group of 3 recently approved drugs and biologicals that 
appeared on the ASP Drug Pricing Files (including one biosimilar 
biological product) was 9.0 percent. Excluding the biosimilar 
biological product results in a difference of 3.5 percent. The 
difference was determined by comparing a partial quarter WAC-based 
payment amount determined under section 1847A(c)(4) of the Act to the 
next quarter's ASP-based payment amount. These findings are in general 
agreement with MedPAC's findings.
    Although we are able to provide examples of the relative 
differences between ASP and WAC based payment limits, and we anticipate 
some savings from the proposals, we cannot estimate the magnitude of 
savings over time because we cannot determine how many new drugs and 
biologicals subject to partial quarter pricing will appear on the ASP 
Drug Pricing files in the future or how many Part B claims for these 
products will be paid. This limitation also applies to contractor-
priced drugs and biologicals that have HCPCS codes and are in their 
first quarter of sales. Finally, the claims volume for contractor-
priced drugs and biologicals that are billed using miscellaneous or Not 
Otherwise Classified codes, such as J3490 and J3590, cannot be 
quantified. We would like to note that for the three drugs discussed in 
the preceding paragraph, Medicare Part B payments for individual doses 
of each drug range from approximately $3,000 to $10,000. The payment 
changes proposed in this rule would have resulted in a little less than 
$100 to $300 savings in Medicare allowed charges for each dose.
    Although we cannot estimate the overall savings to the Medicare 
Program or to beneficiaries, we would like to point out that this 
change in policy is likely to decrease copayments for individual 
beneficiaries who are prescribed new drugs. Given that launch prices 
for single doses for some new drugs may range from tens to hundreds of 
thousands of dollars, a 3 percentage point reduction in the total 
payment allowance will reduce a patient's 20 percent Medicare Part B 
copayment. This proposed approach can result in savings to an 
individual beneficiary and can help Medicare beneficiaries afford to 
pay for new drugs by reducing out of pocket expenses.
    The 3 percent add-on is expected to reduce the difference between 
acquisition cost and certain WAC-based Part B drug payments, creating 
greater parity between the two. Based on MedPAC's June 2017 Report to 
Congress, we do not anticipate that this change will result in payments 
amounts that are below acquisition cost or that the proposals will 
impair providers' or patients' access to Part B drugs.
2. Proposed Changes to the Regulations Associated With the Ambulance 
Fee Schedule
    As discussed in section III B.2. of this proposed rule, section 
50203(a) of the Bipartisan Budget Act of 2018 amended section 
1834(l)(12)(A) and (l)(13)(A) of the Act to extend the payment add-ons 
set forth in those subsections through December 31, 2022. The ambulance 
extender provisions are enacted through legislation that is self-
implementing. A plain reading of the statute requires only a 
ministerial application of the mandated rate increase and does not 
require any substantive exercise of discretion on the part of the 
Secretary. As a result, there are no policy proposals associated with 
these legislative provisions or associated impact in this rule. We are 
proposing only to revise the dates in Sec.  414.610(c)(1)(ii) and 
(c)(5)(ii) to conform the regulations to these self-implementing 
statutory requirements.
    In addition, as discussed in section III.B. 3. of this proposed 
rule, section 53108 of the BBA amended section 1834(l)(15) of the Act 
to increase the payment reduction from 10 percent to 23 percent 
effective for ambulance services furnished on or after October 1, 2018 
consisting of non-emergency basic life support services (BLS) involving 
transports of an individual with end stage renal disease for renal 
dialysis services furnished other than on an emergency basis by a 
provider of services or a renal dialysis facility. The 10 percent 
reduction applies for such ambulance services furnished during the 
period beginning on October 1, 2013 and ending on September 30, 2018.
    This statutory requirement is self-implementing. A plain reading of 
the statute requires only a ministerial application of the mandated 
rate decrease and does not require any substantive exercise of 
discretion on the part of the Secretary. As a result, there are no 
policy proposals associated with these legislative provisions or 
associated impact in this rule. We are proposing to revise Sec.  
414.610(c)(8) to conform the regulations to this self-implementing 
statutory requirement.
3. Clinical Laboratory Fee Schedule: Proposed Change to the Majority of 
Medicare Revenues Threshold in Definition of Applicable Laboratory
    As discussed in section III.A. of this proposed rule, section 1834A 
of the Act, as established by section 216(a) of the Protecting Access 
to Medicare Act of 2014 (PAMA), required significant changes to how 
Medicare pays for CDLTs under the CLFS. The CLFS final rule titled, 
Medicare Clinical Diagnostic Laboratory Tests Payment System final rule 
(CLFS final rule), published in the June 23, 2016 Federal Register, 
implemented section 1834A of the Act. Under the CLFS final rule (81 FR 
41036), ``reporting entities'' must report to CMS during a ``data 
reporting period'' ``applicable information'' (that is, certain private 
payor data) collected during a ``data collection period'' for their 
component ``applicable laboratories.'' In general, the payment amount 
for each clinical diagnostic laboratory test (CDLT) on the CLFS 
furnished beginning January 1, 2018, is based on the applicable 
information collected during the 6-month data collection period and 
reported to us during the 3-month data reporting period, and is equal 
to the weighted median of the private payor rates for the CDLT.
    An applicable laboratory is defined at Sec.  414.502, in part, as 
an entity that is a laboratory (as defined under the Clinical 
Laboratory Improvement Amendments (CLIA) definition at Sec.  493.2) 
that bills Medicare Part B under its own National Provider Identifier 
(NPI). In addition, an applicable laboratory is an entity that receives 
more than 50 percent of its Medicare revenues during a data collection 
period from the CLFS and/or the PFS. We refer to this component of the 
applicable laboratory definition as the ``majority of Medicare revenues 
threshold.'' The definition of applicable laboratory also includes a 
``low expenditure threshold'' component which requires an entity to 
receive at least $12,500 of its Medicare revenues

[[Page 36048]]

from the CLFS during a data collection period, for its CDLTs that are 
not advanced diagnostic laboratory tests (ADLTs).
    In determining payment rates under the private payor rate-based 
CLFS, one of our objectives is to obtain as much applicable information 
as possible from the broadest possible representation of the national 
laboratory market on which to base CLFS payment amounts, for example, 
from independent laboratories, hospital outreach laboratories, and 
physician office laboratories, without imposing undue burden on those 
entities. We believe it is important to achieve a balance between 
collecting sufficient data to calculate a weighted median that 
appropriately reflects the private market rate for a CDLT, and 
minimizing the reporting burden for entities. In response to 
stakeholder feedback and in the interest of facilitating our goal, we 
are proposing to revise the majority of Medicare revenues threshold 
component of the definition of applicable laboratory at Sec.  
414.502(3) to exclude Medicare Advantage payments under Medicare Part C 
from the definition of total Medicare revenues (that is, the 
denominator of the majority of Medicare threshold equation). This 
change would permit laboratories with a significant Medicare Part C 
revenue component to meet the majority of Medicare revenues threshold 
and potentially qualify as an applicable laboratory (if it also meets 
the low expenditure threshold). As a result, a broader representation 
of the laboratory industry may report applicable information from which 
to determine payment rates under the CLFS. For a complete discussion of 
our proposal to revise the majority of Medicare revenues threshold 
component of the definition of applicable laboratory under the Medicare 
CLFS, we refer readers to section III A. of this proposed rule.
a. Estimation of Increased Reporting
    To estimate the potential impact of excluding Medicare Advantage 
plan payments from total Medicare revenues (that is, the denominator of 
the low expenditure threshold) on the number of laboratories meeting 
the majority of Medicare revenues threshold, using CY 2017 Medicare 
claims data, we compared the number of billing NPIs that would have met 
the majority of Medicare revenues threshold with Medicare Advantage 
plan revenues included in total Medicare revenues (which is the current 
requirement) versus the number of billing NPIs that would meet the 
majority of Medicare revenues threshold had Medicare Advantage plan 
payments been excluded from total Medicare revenues (which is the 
proposed change). We found that excluding Medicare Advantage plan 
payments from total Medicare revenues increased the level of 
laboratories meeting the majority of Medicare revenues threshold by 
approximately 43 percent. In other words, we estimate that excluding 
Medicare Advantage plan payments from total Medicare revenues (the 
denominator) of the majority of Medicare revenues threshold, and 
keeping the numerator constant (that is revenues from only the CLFS and 
or PFS) yields an increase of 43 percent in the number of laboratories 
meeting the majority of Medicare revenues threshold.
    As discussed on the CLFS website, our summary analysis of data 
reporting from the initial data reporting period under the Medicare 
CLFS private payor rate-based payment system, indicated that we 
received applicable information from 1,942 applicable laboratories 
reporting over 4.9 million records. Applying the projected 43 percent 
increase to the number of applicable laboratories from the first data 
reporting period (1,942 x 1.43) yields an estimated 2,777 laboratories 
that would meet the majority of Medicare revenues threshold, which 
reflects an additional 835 laboratories. Provided all other required 
criteria for applicable laboratory status are met (including the low 
expenditure threshold of receiving at least $12,500 in CLFS revenues 
during a data collection period) a laboratory would report applicable 
information for the next data reporting period.
    To determine the estimated reporting burden for an applicable 
laboratory, we looked at the distribution of reported records that 
occurred for the first data reporting period. The average number of 
records reported for an applicable laboratory for the first data 
reporting period was 2,573. The largest amount of records reported for 
an applicable laboratory was 457,585 while the smallest amount reported 
was 1 record. A summary of the distribution of reported records from 
the first data collection period is illustrated in Table 95.

                                          Table 95--Summary of Records Reported for First Data Reporting Period
                                                               [By applicable laboratory]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                     Percentile distribution of records
              Total records                  Average     Min records   Max records ---------------------------------------------------------------------
                                             records                                    10th          25th          50th          75th          90th
--------------------------------------------------------------------------------------------------------------------------------------------------------
4,995,877...............................        2,573             1       457,585            23            79           294         1,345         4,884
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Presuming that all of the additional laboratories that are 
projected to meet the majority of Medicare revenues threshold, that is 
approximately 835, also meet all of the criteria necessary to receive 
applicable laboratory status, as defined at Sec.  414.502, they would 
be an applicable laboratory and report applicable information for the 
next data reporting period, January 1, 2020 through March 31, 2020. 
Using the mid-point of the percentile distribution of reported records 
from the initial data reporting period, that is approximately 300 
records reported per applicable laboratory (50th percentile for the 
first data reporting period was 294), we estimate an additional 250,500 
records would be reported for the next data reporting period (835 
laboratories x 300 records per laboratory = 250,500). This represents 
an increase in data reporting of about 5 percent over the number of 
records reported for the initial data reporting period (250,500 
additional records/4,995,877 = .05). In other words, using the 
approximate mid-point of reported records for the first data reporting 
period, we estimate that our proposed change to the majority of 
Medicare revenues threshold would increase the total amount of records 
reported by approximately 5 percent. As illustrated in Table 95, the 
number of records reported varies greatly, depending on the volume of 
services performed by a given laboratory. Laboratories with larger test 
volumes, for instance at the 90th percentile, should expect to report 
more records as compared to the midpoint used for this analysis. 
Likewise, laboratories with smaller test volume, for instance at the 
10th percentile, should expect to report

[[Page 36049]]

less records as compared to the midpoint.
b. Minimal Impact Expected on CLFS Rates
    We note that there would only be an associated Medicare cost or 
savings to the extent that the additional applicable laboratories are 
paid at a higher (or lower) private payor rate, as compared to other 
laboratories that reported previously and to the extent that the volume 
of services performed by these ``additional'' applicable laboratories 
is significant enough to make an impact on the weighted median of 
private payor rates. We have no reason to believe that increasing the 
level of participation would result in a measurable cost difference 
under the CLFS. Given that the largest laboratories with the highest 
test volumes, by definition, dominate the weighted median of private 
payor rates, and the largest laboratories reported data for the 
determination of CY 2018 CLFS rates and are expected to report again, 
we do not expect the additional reported data resulting from our 
proposed change to the majority of Medicare revenues threshold to have 
a predictable, direct impact on CLFS rates. However, we believe that 
this proposal responds directly to stakeholder concerns regarding the 
number of applicable laboratories reporting applicable information for 
the initial data reporting period. Therefore, in an effort to increase 
the number of laboratories qualifying for applicable laboratory status, 
we are proposing a change to the majority of Medicare revenues 
threshold so that laboratories furnishing tests to a significant level 
of Medicare Part C enrollees may qualify as applicable laboratories and 
report data to us.
4. Appropriate Use Criteria for Advanced Diagnostic Imaging Services
    The CY 2016 PFS final rule with comment period established an 
evidence-based process and transparency requirements for the 
development of AUC and stated that the AUC development process 
requirements, as well as the application process that organizations 
must comply with to become qualified PLEs did not impact CY 2016 
physician payments under the PFS (80 FR 71362). The CY 2017 PFS final 
rule identified the requirements CDSMs must meet for qualification and 
stated that the CDSM requirements, as well as the application process 
that CDSM developers must comply with for their mechanisms to be 
specified as qualified under this program, did not impact CY 2017 
physician payments under the PFS (81 FR 80546). The CY 2018 PFS rule 
finalized the effective date of January 1, 2020, on which the AUC 
consulting and reporting requirements will begin, and extended the 
voluntary consulting and reporting period to 18 months. Therefore, we 
stated these proposals did not impact CY 2018 physician payments under 
the PFS (82 FR 53349) and noted we would provide an impact statement 
when applicable in future rulemaking.
    This proposed rule includes proposals to modify the Medicare AUC 
Program and addresses the impacts related to the actions taken by 
ordering professionals who order advanced diagnostic imaging services 
and those who furnish the professional and technical components of 
advanced diagnostic imaging services. The proposed rule proposes to 
modify the consultation requirement in Sec.  414.94(j); therefore, this 
analysis estimates the impact of consultations by ordering 
professionals. The proposed rule proposes to clarify the reporting 
requirement in Sec.  414.94(k), and this analysis estimates the impact 
of reporting AUC consultation information. The proposed rule also 
proposes to modify the significant hardship exceptions in Sec.  
414.94(i), therefore this analysis estimates the impact of a self-
attestation process for ordering professionals. We also estimate the 
further reaching impacts of the AUC program in the detailed analysis 
that follows, assuming that some ordering professionals will purchase a 
qualified CDSM integrated within their existing EHR and others may 
purchase an EHR system in order to obtain an integrated qualified CDSM. 
We believe that in the beginning of this program due to the additional 
action required on the part of the ordering professional, it may take 
longer for a Medicare beneficiary to obtain an order for an advanced 
diagnostic imaging service, and therefore, we have calculated an 
estimated impact to Medicare beneficiaries.
    This proposed rule discusses options to report the required claims-
based AUC consultation information required in Sec.  
414.94(g)(1)(iv)(B) and we estimate the impact of our proposal to use 
existing coding methods (G-codes and HCPCS modifiers) to report that 
information. Finally, we measure the estimated impact on furnishing 
professionals and facilities of the proposed expansion of the 
definition of applicable setting in Sec.  414.94(b). While the 
consultation and reporting requirements of this program are effective 
beginning January 1, 2020 with an Educational and Operations Testing 
Period, we attempt in this analysis to identify areas of potential 
qualitative benefits to both Medicare beneficiaries and the Medicare 
program.
a. Impact of Consultations by Ordering Professionals
    In this proposed rule, we are proposing modifications to the AUC 
program largely in response to public comments and recommendations as 
we believe these modifications are also important in minimizing burden 
of the AUC program on ordering professionals, furnishing professionals, 
and facilities. Specifically, we include a proposal regarding who, when 
not personally performed by the ordering professional, may consult AUC 
through a qualified CDSM and still meet the requirements of our 
regulations. In the CY 2018 PFS final rule, we estimated the consulting 
requirement based on the 2 minute effort of a family and general 
practitioner to result in an annual burden of 1,425,000 hours 
(43,181,818 consultations (Part B analytics 2014 claims data) x 0.033 
hr/consultation) at a cost of $275,139,000 (82 FR 53349).
    An important difference from last year's analysis is that this 
year's analysis includes estimates for non-physician practitioners that 
order advanced diagnostic imaging services. For the purposes of this 
analysis, we assume that orders for advanced diagnostic imaging 
services would be placed by ordering professionals that are non-
physician practitioners in the same percent as the numbers of non-
physician practitioners are relative to the total number of non-
institutional providers. Therefore, this analysis assumes that 40 
percent of all advanced diagnostic imaging services would be ordered by 
non-physician practitioners. While non-physician practitioners may not 
order advanced diagnostic imaging services in the same proportion as 
their numbers, we did not have other data to use for this estimate. We 
specifically solicit comment and data on alternative assumptions about 
the number of non-physician practitioners who order advanced imaging 
services.
    In addition, in this proposed rule we propose that auxiliary 
personnel may perform the AUC consultation when under the direction of, 
and incident to, the ordering professional's services. Due to this 
proposed change, we estimate that the majority, or as many as 90 
percent, of practices would employ the use of auxiliary personnel, 
working under the direction of the ordering professional, to interact 
with the CDSM for AUC consultation for advanced diagnostic imaging 
orders. We also considered leaving the policy unchanged, and smaller 
modifications to that could expand who performs the

[[Page 36050]]

consultation to a single type of non-physician practitioner. However, 
we believe this proposal maximizes burden reduction effort as 
illustrated in the following updated estimate of consultation burden.
    To estimate the burden of this modification, we calculated the 
effort of a 2-minute consultation with a qualified CDSM by a registered 
nurse (occupation code 29-1141) with mean hourly wage of $35.36 and 100 
percent fringe benefits to be $2.33/consultation ($35.36/hour x 2 x 
0.033 hour). If 90 percent of consultations (1,282,500 hours) are 
performed by such auxiliary personnel then annually the burden estimate 
would be $90,698,400 (1,282,500 hours x $70.72/hour) for auxiliary 
personnel to consult. We acknowledge that some AUC consultations will 
not be performed by other auxiliary personnel, therefore the remaining 
total annual burden we estimate is $31,810,275 for this proposed 
consultation requirement. As a result of these assumptions and 
calculations, we estimate a reduction in consultation burden from cost 
of $275,139,000 to $122,508,675, which results in a proposed net burden 
reduction of $152,630,325.
b. Impact of Significant Hardship Exceptions for Ordering Professionals
    We previously identified exceptions to the requirement that 
ordering professionals consult specified applicable AUC when ordering 
applicable imaging services (81 FR 80170). Our original intention was 
to design the AUC hardship exception process in alignment with the EHR 
Incentive Program and then the MIPS ACI performance category (now 
promoting interoperability). However, in this proposed rule, we propose 
to modify the significant hardship exception criteria under Sec.  
414.94(i)(3) to be specific to the Medicare AUC program and independent 
of other Medicare programs both in policy and process. Specifically, we 
are proposing that all ordering professionals self-attest if they are 
experiencing a significant hardship at the time of placing an advanced 
diagnostic imaging order. Since the Medicare EHR Incentive Program has 
ended and we are unable to continue incorporating regulation that is no 
longer in effect, we did not consider leaving this policy unchanged. We 
also considered using a hardship application submission process. 
However, we believe that this proposed self-attestation process 
maximizes burden reduction effort as illustrated in the following 
updated estimate of ordering professionals subject to a consultation 
burden.
    To estimate the impact of our proposal to modify this section and 
create a hardship exception specific to this program we attempted to 
identify how many ordering professionals would be subject to this 
program.
    Medicare non-institutional Part B claims for the first 6 months of 
2014 shows that for claims for an advanced diagnostic imaging service 
that listed an NPI for the ordering/referring provider, up to 90-
percent of claims include only 18 different provider specialties. These 
specialties include: Emergency Medicine; Internal Medicine; Family 
Practice; Cardiology; Hematology/Oncology; Orthopedic Surgery; 
Neurology; Urology; Physician Assistant; Nurse Practitioner; Pulmonary 
Disease; General Surgery; Neurosurgery; Medical Oncology; 
Gastroenterology; Radiation Oncology; Otolaryngology; and Diagnostic 
Radiology. We then used CMS data that served to create Table II.8 of 
the 2014 Medicare Statistics Book and were able to identify how many 
practitioners in each of those specialties were participating in 
Medicare program. Table II.8 of the 2014 Medicare Statistics Book 
combines many of these specialties into higher level groupings and 
displays the total number of practitioners participating in the 
Medicare program. However, we used more granular information that 
identifies the number of practitioners participating in the Medicare 
program by an individual specialty rather than higher level groupings 
(table available at https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/CMSProgramStatistics/2016/Downloads/PROVIDERS/2016_CPS_MDCR_PROVIDERS_6.pdf). For example, Table 
II.8 of the 2014 Medicare Statistics Book combines all surgeons into 
one category whereas we used detailed information for the individual 
surgical specialties of general surgery and orthopedic surgery for this 
estimate.
    Using this more specific data for the 18 specialties, we estimate 
the count of practitioners that will be ordering professionals under 
the AUC program to be 586,386. There are limitations as we do not have 
data on the actual number of practitioners who order advanced 
diagnostic imaging services because information about the ordering 
professional is not required to be included on the Medicare claim form 
for advanced diagnostic imaging services.
    In the absence of data on the breadth of professionals who would be 
required to consult AUC, we assumed that professionals in the 
specialties listed earlier could potentially be subject to these 
requirements because some professionals within a specialty may order 
these imaging services. We specifically request comments and data on 
the numbers of professionals in the specialties that actually order 
advanced imaging services.
    With respect to the hardship exception, based on 2016 data from the 
Medicare EHR Incentive Program and the 2019 payment year MIPS 
eligibility and special status file, we estimated that 6,699 
respondents in the form of eligible clinicians, groups, or virtual 
groups will submit a request for a reweighting to zero for the 
advancing care information performance category due to extreme and 
uncontrollable circumstances or as a result of a decertification of an 
EHR. For the purposes of this analysis, we cautiously estimate that 
each of the 6,699 respondents represents a unique ordering professional 
and that all respondents who experience extreme and uncontrollable 
circumstances or have an EHR that is decertified are ordering 
professionals who would self-attest to a significant hardship exception 
under the AUC program. Nevertheless, we have used this information to 
update our estimate that there are 579,687 ordering professionals 
subject to this program.
    We believe that the proposed significant hardship exception at 
Sec.  414.94(i) would further reduce the burden of this program if 
finalized for four reasons. First, due to the availability of a 
significant hardship exception there will likely be fewer ordering 
professionals consulting specified applicable AUC. Second, the self-
attestation process is a less burdensome proposal when compared to the 
alternative of a hardship application process that may have both 
regulatory impact and information collection requirements. Third, any 
application or case-by-case determination would necessitate immediate 
infrastructure development by CMS directly or through one or more 
Medicare Administrative Contractors (MACs), which adds burden and 
impact to this program. Finally, the proposed self-attestation process 
requires no verification on the part of the furnishing professional or 
facility required to report AUC consultation information on the 
Medicare claim, thus minimizing burden for both ordering professionals, 
furnishing professionals and facilities. While some of the efficiencies 
gained from a self-attestation process are qualitative in nature and 
difficult to measure, such as the streamlined

[[Page 36051]]

reporting, we believe that relative to other regulatory approaches this 
proposal uses a least burdensome approach.
    We recognize that ordering professionals would store documentation 
supporting the self-attestation of a significant hardship. Storage of 
this information could involve the use of automated, electronic, or 
other forms of information technology at the discretion of the ordering 
professional. We estimate that the average time for office clerical 
activities associated with this task to be 10 minutes. To estimate the 
burden of this storage, we expect that a BLS occupation title 43-6013 
Medical Secretary with a mean hourly rate of $17.25 and 100-percent 
fringe benefits would result in a calculated effort of 10 minutes of 
clerical work to be $5.76 ($17.25/hour x 2 x 0.167 hour). If 6,699 
separate ordering professionals require that a Medical Secretary 
perform the same clerical activity on an annual basis, then this 
equates to a cost of approximately $38,596 per year. We seek comment to 
inform these burden estimates.
c. Impact of Consultations Beyond the Impact to Ordering Professionals
    While we have already discussed the time and effort to consult 
specified applicable AUC through a qualified CDSM here and in previous 
rulemaking (81 FR 80170), we believe the impact of this program is 
extensive as it will apply to every advanced diagnostic imaging service 
(for example, magnetic resonance imaging (MRI), computed tomography 
(CT) or positron emission tomography (PET)) and crosses almost every 
medical specialty. Therefore, we also have described in this detailed 
analysis the impacts of AUC consultation beyond the act of consulting 
specified applicable AUC.
(1) Transfers From Ordering Professionals to Qualified CDSMs and EHR 
Systems
    The first additional impact we identified is upstream in the 
workflow of the AUC consultation and represents the acquisition cost, 
training, and maintenance of a qualified CDSM. These tools may be 
modules within or available through certified EHR technology (as 
defined in section 1848(o)(4)) of the Act or private sector mechanisms 
independent from certified EHR technology or established by the 
Secretary. Currently, none are established by the Secretary. 
Additionally, for the purposes of this program, as required by statute, 
one or more of such mechanisms is available free of charge. For this 
impact analysis we will assume three potential scenarios as low, 
medium, and higher burden assessments of this consultation requirement. 
First, we assume that some number of ordering professionals consults a 
qualified CDSM available free of charge. Second, we assume that some 
number purchase a qualified CDSM to integrate within an existing EHR 
system. Third, we assume that some do not currently have an EHR system 
and, as a result of the statutory requirement to consult with AUC, 
would purchase an EHR system with an integrated qualified CDSM to 
consult specified applicable AUC for the purposes of this program.
    In the lowest estimate of burden, every AUC consultation would take 
place using a qualified CDSM available free of charge integrated into 
an EHR system and add no additional cost to the requirement in Sec.  
414.94(j) of this proposed rule. While we did not base this estimate on 
absolute behaviors by all those who have ordered advanced diagnostic 
imaging services, we believe it is reasonable to estimate that as many 
as 75 percent of an assumed annual 40,000,000 orders for advanced 
diagnostic imaging services could occur at no additional cost beyond 
the time and effort to perform the consultation.
    In contrast, some ordering professionals may choose to purchase a 
qualified CDSM that is integrated within their EHR. To estimate how 
many ordering professionals may choose to purchase an integrated 
qualified CDSM, we consulted the 2015 National Electronic Health 
Records Survey \47\ (NEHRS), which is conducted by the National Center 
for Health Statistics (NCHS) and sponsored by the Office of the 
National Coordinator for Health Information Technology (ONC). NEHRS is 
a nationally representative mixed mode survey of office-based 
physicians that collects information on physician and practice 
characteristics, including the adoption and use of EHR systems. In the 
United States in 2015, 86.9 percent of office-based physicians used any 
EHR/EMR, with significantly higher adoption by general or family 
practice physicians (92.7 percent, p-value <0.05), and slightly lower 
for medical non-primary care physicians (84.4 percent). Given that 
approximately 87 percent of office-based physicians have adopted EHR 
systems, we believe it is likely that the majority will prefer a 
qualified CDSM integrated with EHR. While we note that qualified CDSMs 
available free of charge are also integrated within one or more EHR 
systems, the following exercise estimates the time and effort to 
purchase, install, train, and maintain a qualified CDSM integrated into 
an EHR system.
---------------------------------------------------------------------------

    \47\ Jamoom E, Yang N. Table of Electronic Health Record 
Adoption and Use among Office-based Physicians in the U.S., by 
State: 2015 National Electronic Health Records Survey. 2016.
---------------------------------------------------------------------------

    Again, as stated above, we do not have data on the number of 
clinicians who order advanced diagnostic imaging services, and we have 
made overarching assumptions to look at particular specialty areas that 
in our claims analysis order these advanced diagnostic imaging 
services. We assumed all individual clinicians in these specialty areas 
could potentially be subject to these requirements. Adding the number 
of clinicians in each of the specialty areas results in 586,386 
ordering professionals. We also did not make a distinction between 
individual professionals and groups, as further explained below.
    To calculate the impact of a single purchase, we believe that 
ordering professionals, either in groups or individually, would spend 
an estimated $15,000 for a one-time purchase of an integrated qualified 
CDSM, including installation and training. We assume that all of these 
costs are based on market research and incurred over the course of 5 
years. We also assume that the $15,000 purchase would be made by each 
ordering professional and did not take into account the potential that 
a group practice might incur a discounted price per user based on the 
number of ordering professionals in the practice. These assumptions 
could significantly alter the impact estimate and we seek comment on 
such assumptions.
    Given the difficult nature of deriving these estimates based on 
limited data, we solicit comment and information on the preference that 
physicians and practitioners might have for using an integrated 
qualified CDSM--a free CDSM or a CDSM that is not free but integrated 
within an existing EHR system. Also, if purchased, whether this would 
be purchased at the group practice level to be made available to all 
clinicians in the practice for the same cost that would be incurred by 
a single practitioner purchasing the same qualified CDSM, and whether 
the cost of purchasing a CDSM would be incurred in a single year or 
over multiple years.
    For the purposes of estimating the transfer of costs from ordering 
professionals to qualified CDSM developers, of the estimated 579,687 
practitioners that are likely subject to this program, we excluded 
181,653 ordering professionals with specialties whose practitioners 
order on average fewer than 20 advanced diagnostic imaging services per 
year (physician

[[Page 36052]]

assistant, nurse practitioner, and diagnostic radiology). The 
assumption is that lower volume ordering professionals would select a 
qualified CDSM that is free of charge. This updates the estimate to 
consider 398,034 ordering professionals who may purchase an integrated 
qualified CDSM. To this end, if we assume 346,290 (398,034 ordering 
professionals x 87 percent) ordering professionals already have an EHR 
system and 30 percent of these ordering professionals (346,290 x 30 
percent, or 103,887) make this purchase for $15,000 and spend $1,000 
annually to maintain their system for 5 years (initial acquisition cost 
in year 1 and maintenance costs in years 2-5), then the total annual 
cost is estimated to be $394,770,600 ((103,887 x $19,000)/5 years)).
    It is also reasonable to assume that some ordering professionals 
may not need additional training in using a qualified CDSM because the 
EHR Incentive Program required CDS as a core measure. In addition, the 
program incentivized use of computerized provider order entry (CPOE)--
an electronic submission of pharmacy, laboratory, or radiology orders. 
To determine readiness among Medicare practitioners for these and other 
measures, the 2011 Meaningful Use Census \48\ (RTI International, 2012) 
observed that those participating in the EHR Incentive Program in 2011 
on average met and exceeded the established 30 percent threshold for 
meaningful use of CPOE in Stage 1. Analysis of the distribution of 
performance on these measures shows that 86 percent of eligible 
participants were well over the established thresholds. It is important 
to note that the CPOE measure had a higher threshold in Stage 2, and 60 
percent of eligible participants in 2011 attested to meaningful use are 
already meeting this higher threshold. This report suggests that some 
ordering professionals may be well prepared to adopt a qualified 
clinical decision support mechanism, as this experience offset may 
yield lower costs and burden to learn to incorporate decision support 
into the ordering workflow through shorter training times.
---------------------------------------------------------------------------

    \48\ Vincent, A. EHR Incentive Program: 2011 Meaningful Use 
Census. RTI Internatoinal. November 2012.
---------------------------------------------------------------------------

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

    \49\ McCormack M, ``EHR Software Buyer Report--2014'' available 
at https://www.softwareadvice.com/resources/ehr-buyer-report-2014/.
---------------------------------------------------------------------------

    These estimates are highly sensitive to our assumptions of both the 
percent of physicians who would purchase an EHR system as a result of 
this program and the costs of an EHR system. We recognize that due to 
the limited data available to make these assumptions our estimates are 
likely high and we seek comment and information about these 
assumptions. These estimates might be viewed as an upper bound of the 
impact of this program beyond consultation with a free tool and note 
that at the time of publication there were three free tools available 
as indicated on the CMS website at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/CDSM.html.
(2) Impact to Medicare Beneficiaries
    Additionally, we believe that the additional 2-minute consultation 
will impact the Medicare beneficiary when their advanced diagnostic 
imaging service is ordered by the ordering professional by introducing 
additional time to their office visit. To estimate this annual cost, we 
multiplied the annual burden of 1,425,000 hours by the BLS occupation 
code that represents all occupations in the BLS (00-0000) as mean 
hourly wage plus 100 percent fringe ($47.72/hr) for a total estimate of 
$68,001,000 per year. Over time, there may be process efficiencies 
implemented in one or more practices similar to the benefits of 
deploying CDS \50\ (Berner, 2009; Karsh, 2009) that decrease this 
estimate. For example, we will assume that every time an advanced 
diagnostic imaging service is ordered, it is the result of a visit by a 
Medicare beneficiary for evaluation and management. Then, let us assume 
that 50 percent of practices implemented an improvement process that 
streamlined the AUC consultation such that Medicare beneficiaries who 
visited those practices spent the same amount of time in the 
physician's office regardless of whether an advanced diagnostic imaging 
service was ordered. As a result of this improvement process in 
practice we could estimate such efficiency would offset the estimated 
burden by $34,000,500 annually. Although we cannot at this time 
identify

[[Page 36053]]

a concrete solution, we are seeking comment on this detailed analysis 
to inform future rulemaking.
---------------------------------------------------------------------------

    \50\ Berner ES. Clinical decision support systems: State of the 
Art. AHRQ Publication No. 09-0069-EF. Rockville, Maryland: Agency 
for Healthcare Research and Quality. June 2009. Karsh B-T. Clinical 
practice improvement and redesign: how change in workflow can be 
supported by clinical decision support. AHRQ Publication No. 09-
0054-EF. Rockville, Maryland: Agency for Healthcare Research and 
Quality. June 2009.
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d. Considering the Impact of Claims-Based Reporting
    In the CY 2018 PFS proposed rule (82 FR 34094), we discussed using 
a combination of G-codes and modifiers to report the AUC consultation 
information on the Medicare claim. We received numerous public comments 
objecting to this potential solution. In the 2018 PFS final rule, we 
agreed with many of the commenters that additional approaches to 
reporting AUC consultation information on Medicare claims should be 
considered, and in the opinion of some commenters, reporting unique 
consultation identifiers (UCIs) would be a less burdensome and 
preferred approach. We had the opportunity to engage some stakeholders 
over the last 6 months and we understand that some commenters from the 
previous rule continue to be in favor of a UCI. Practically examining 
the workflow of an order for an advanced diagnostic imaging service 
before and after implementation of the Medicare AUC program, we see 
that in general the process remains largely unchanged. Before and after 
the implementation of this program, an ordering professional could 
employ support staff to transmit an order for an advanced diagnostic 
imaging service from his or her office to an imaging facility, 
physician office, or hospital that furnishes advanced diagnostic 
imaging services. After implementation of this program, the ordering 
professionals, furnishing professionals and facilities must adapt this 
existing workflow to accommodate new information not previously 
required on orders for advanced diagnostic imaging services.
    We considered leaving the policy unchanged, and we also considered 
writing new regulations requiring larger modifications to the form for 
manner by which AUC consultation information is communicated from the 
ordering professional to the furnishing professional or facility. 
However, we believe the proposal described in this proposed rule 
minimizes burden and maximizes efficiency by reporting through 
established coding methods, to include G-codes and modifiers, to report 
the required AUC information on Medicare claims.
(1) Impact on Transmitting Order for Advanced Diagnostic Imaging 
Services
    We estimate that including AUC consultation information on the 
order to the furnishing professional or facility is estimated as the 
additional 5 minutes spent by a medical secretary (43-6013), at a mean 
hourly rate of $17.25 plus 100 percent fringe to transmit the order for 
the advanced diagnostic imaging service. We believe the estimate of 5 
minutes is an estimate that accounts for different transmittal methods, 
such as through an integrated EHR system, by facsimile, or via 
telephone call directly to the office of the furnishing professional or 
facility. In aggregate, if we assume that 40,000,000 advanced 
diagnostic imaging services are ordered annually, then the total annual 
burden to communicate additional information in the order is estimated 
as $114,540,000 ($17.25/hr x 2 x 0.083 hr x 40,000,000 orders).
(2) Impact on CDSM Developers
    We believe that in considering a distinct UCI we also considered 
updating the requirements of a qualified CDSM in Sec.  
414.94(g)(1)(vi)(B). This would incur additional costs for the 
developers of these mechanisms to accommodate formatting changes if 
instructed by CMS. We continue to believe that participation by CDSM 
developers in this program is voluntary, that any considerations of 
proposed changes to this policy maximize benefits and minimize burden 
to ordering professionals and furnishing professionals and facilities. 
Internally, CMS has explored the possibility of using a UCI to 
determine feasibility, and provide a detailed estimate of costs to 
develop, test, and implement an update in the form and manner of the 
UCI generated by the CDSM.
    To estimate the costs to develop, test, and implement this update, 
we will provide a relevant case study. In 1998, the Year 2000 
Information and Readiness Disclosure Act (Pub. L. 105-271) was passed 
to ensure continuity of operations in the year 2000. At the time of 
passage, millions of information technology computer systems, software 
programs, and semiconductors were not capable of recognizing certain 
dates after December 31, 1999, and without modification would read 
dates in the year 2000 and thereafter as if those dates represented the 
year 1900 or thereafter, or would have failed to process those dates 
entirely. The federal government had budgeted $8,300,000,000 to 
continue processing dates in 2000 and beyond (Department of Commerce, 
1999). Additional estimates to repair the date in a form and manner 
accommodating the year 2000 varied, but one estimate \51\ from analysis 
of the 1998-99 budget bill of the state of California estimated 
$241,000,000 to repair 3,000 systems, or $80,333.33 per system, which 
adjusted for inflation using the CPI-U, U.S. city average series for 
all items, not seasonally adjusted, represents $123,775.95 per system 
in 2018. If all 16 qualified CDSMs performed an update to the 
formatting of the UCI to appear on certification or documentation of 
every AUC consultation, then the one-time total cost incurred by all 
CDSM developers would be $1,980,415.20. Although this does not 
represent a direct transfer of costs from CDSM developers to savings 
and efficiencies for ordering professionals, furnishing professionals 
and facilities, we do believe that as a result of such a policy 
modification that the ordering professional could directly communicate 
a single AUC UCI, and furnishing professionals and facilities can 
report UCI in place of identifying each individual CDSM qualified for 
the purposes of this program.
---------------------------------------------------------------------------

    \51\ LAO Analysis of the 1998-99 Budget Bill Information 
Technology Issues. Information Technology Issues Analysis of the 
1998-99 Budget Bill. The Year 2000 (``Y2K'') Computer Problem. 
Published February 18, 1998. Accessed March 25, 2018 at https://www.lao.ca.gov/analysis_1998/info_tech_anl98.html.
---------------------------------------------------------------------------

e. Impact of Expanding Applicable Setting on Furnishing Professionals 
and Facilities
    We expect that an AUC consultation must take place for every 
applicable imaging service furnished in an applicable setting and paid 
for under an applicable payment system. In the CY 2017 PFS final rule 
(81 FR 80170) we codified the definition of applicable setting in Sec.  
414.94(b) to include a physician's office, a hospital outpatient 
department (including an emergency department), an ambulatory surgical 
center, and any other provider-led outpatient setting determined 
appropriate by the Secretary. In this proposed rule, we also include a 
proposal to add independent diagnostic testing facilities to the 
definition of applicable settings under this program. This proposal is 
based on the following factors from 2016 CMS Statistics: (1) An 
independent diagnostic testing facility is independent both of an 
attending or consulting physician's office and of a hospital; (2) 
diagnostic procedures when performed by an independent diagnostic 
testing facility are paid under the PFS; (3) independent facilities 
have increased 5,120 percent from 4,828 in 1990 to 252,044 in 2015; (4) 
of those facilities, 1,125 received total payments in excess of 
$100,000 in 2015; (5) there were 37,038 radiology non-institutional 
providers utilized by fee-for-service Medicare beneficiaries for all 
Part B

[[Page 36054]]

non-institutional provider services in 2015, of which 14,341 received 
total payments in excess of $100,000 in 2015. Taken together, we 
believe this proposal will result in a more even application of the 
Medicare AUC program.
    To estimate the impact of modifications to this proposal, we assume 
based on data derived from the CCW's 2014 Part B non-institutional 
claim line file, which includes services covered by the Part B benefit 
that were furnished during calendar year 2014, that approximately 
40,000,000 advanced diagnostic imaging services are furnished annually, 
but questioned whether for the purposes of this estimate we should 
attribute equal weight for these services furnished by each of the 
following places: (1) A physician's office; (2) a hospital outpatient 
department; (3) an ambulatory surgical center; and (4) an independent 
diagnostic testing facility. Therefore, we sought to determine the 
frequency of advanced diagnostic imaging services furnished by each 
setting.
    For this estimation, we analyzed 2014 Medicare Part B claims data 
to weight the various applicable settings subject to this program. For 
this estimate, we analyzed a count of total services furnished for the 
following 7 Current Procedural Terminology (CPT) codes for advanced 
diagnostic imaging studies: 70450--computed tomography, head or brain, 
without contrast material; 74177--computed tomography, abdomen and 
pelvis, without contrast material; 70553--magnetic resonance (e.g., 
proton) imaging, brain (including brain stem), without contrast 
material, followed by contrast material(s) and further sequences; 
72148--magnetic resonance (e.g., proton) imaging, spinal canal and 
contents, lumbar, without contrast material; 78452--Myocardial 
perfusion imaging, tomographic single-photon emission computed 
tomography (SPECT) including attenuation correction, qualitative or 
quantitative wall motion, ejection fraction by first pass or gated 
technique, additional quantification, when performed, multiple studies, 
at rest and/or stress (exercise or pharmacologic) and/or redistribution 
and/or rest reinjection; 78492--myocardial imaging, positron emission 
tomography (PET), perfusion, multiple studies at rest and/or stress; 
78803--radiopharmaceutical localization of tumor or distribution of 
radiopharmaceutical agent(s), tomographic SPECT; which represented 
10,000,000 total services or approximately a 25 percent sample of the 
40,000,000 total advanced diagnostic imaging services furnished under 
Part B in 2014.
    In this sample, we found the following total services and percent 
of total services for each of the following settings: (1) Physician's 
office, 2,997,460 total services, 28.5 percent; (2) hospital outpatient 
department, 7,465,279 total services, 70.9 percent; (3) ambulatory 
surgical center, 1,062 total services, 0.01 percent; (4) independent 
diagnostic testing facility, 58,900 total services, 0.6 percent. We 
also examined whether the total services furnished in 2015 for each 
setting increased more than 10 percent from 2014. We found the 
following total services and percent change from 2014 for each of the 
following settings: (1) Physician's office, 2,944,144 total services, 2 
percent decrease; (2) hospital outpatient department, 7,854,997 total 
services, 5 percent increase; (3) ambulatory surgical center, 2,900 
total services, 173 percent increase; (4) independent diagnostic 
testing facility, 65,479 total services, 11 percent increase. Taken 
together, we believe these estimates that attribute 70 percent of all 
advanced diagnostic imaging services to outpatient, 28 percent to 
physician's office, and 1 percent each to ambulatory surgical centers 
and independent diagnostic testing facilities, respectively is 
generalizable to the total number of visits by Medicare beneficiaries 
to each of those applicable settings, respectively.
    We do not expect that for the purposes of this program furnishing 
professionals and facilities will need to create new billing practices; 
however, we assume that the majority of furnishing professionals and 
facilities will work to alter billing practices through automation 
processes that accommodate AUC consultation information when furnishing 
advanced diagnostic imaging services to Medicare beneficiaries. 
Therefore, we believe a transfer of costs and benefits will be made 
from furnishing professionals and facilities to medical billing 
companies to create, test, and implement changes in billing practice 
for all affected furnishing professionals and facilities.
    As mentioned earlier, the 2016 CMS Statistics identified 37,038 
radiology non-institutional providers (Table II.8), and 5,470 
ambulatory surgical centers (Table II.5) as of December 31, 2015. 
Because the classification of independent facilities includes both 
diagnostic radiology and diagnostic laboratory tests, we will assume 
that 50 percent of the 252,044 facilities existing in 2015 according to 
2016 CMS Statistics (126,022 facilities) furnish advanced diagnostic 
imaging services. The American Hospital Association Hospital Statistics 
published in 2018 by Health Forum, an affiliate of the American 
Hospital Association, identifies the total number of all U.S. 
registered hospitals to be 5,534. Taken together, we have identified an 
estimated 174,064 furnishing professionals (37,038 radiologists + 5,470 
ASCs + 126,022 independent diagnostic testing facilities + 5,534 
hospitals). We will assume for the purposes of this calculation that 
every identified furnishing professional and facility will choose to 
update their processes for the purposes of this program in the same way 
by purchasing an automated solution to reporting AUC consultation 
information.
    The effective date of January 1, 2020 provides some but not 
extensive time to prepare to update billing processes to accept and 
report AUC consultation information. Requirements at Sec.  414.94(k) 
include the following additional information that must be reported: (1) 
The qualified CDSM consulted by the ordering professional; (2) 
information indicating whether the service ordered would or would not 
adhere to specified applicable AUC, or whether the specified applicable 
AUC consulted was not applicable to the service ordered; (3) the NPI of 
the ordering professional who consulted specified applicable AUC as 
required in paragraph (j) of this section, if different from the 
furnishing professional. Although we are not familiar with any 
automated billing solution currently available that accommodates this 
new information, we seek comment on our estimate that based on medical 
billing and coding for experienced professionals (https://www.mb-guide.org/), which provides estimates ranging from $1,000 to $50,000 for 
medical billing software, for the purposes of this calculation such a 
solution will cost each furnishing professional or facility an 
estimated $10,000. We believe this is an estimate based on the 
assumption that the number of available furnishing professionals and 
facilities does not equal the number of professionals and facilities 
furnishing advanced diagnostic imaging services in the Medicare program 
and although we recognize that more than one furnishing professional or 
facility may use the same billing service, the combined effectiveness 
for an automated solution may decrease overall cost. However, this is 
not an impact on behavior that we could assess before the start of this 
program and we are seeking feedback on these and other estimates 
presented. Therefore, given these assumptions, we estimate that the

[[Page 36055]]

one-time update will cost $1,740,640,000 (174,064 x $10,000).
    The Congressional Budget Office estimates that section 218 of the 
PAMA would save approximately $200,000,000 in benefit dollars over 10 
years from FY 2014 through 2024, which could be the result of 
identification of outlier ordering professionals and also includes 
section 218(a) of the PAMA--a payment deduction for computed tomography 
equipment that is not up to a current technology standard. Because we 
have not yet proposed a mechanism or calculation for outlier ordering 
professional identification and prior authorization, we are unable to 
quantify that impact at this time.
f. Appropriate Use Criteria for Advanced Diagnostic Imaging Services
    We believe that the first 5 years of this program will be dedicated 
to implementation activities, from installation of the technology to 
training to operational and behavioral changes. Information on the 
benefits of adopting qualified CDSMs or automating billing practices 
specifically meeting the requirements in this proposed rule does not 
yet exist--and information on benefits overall is limited. Nonetheless, 
we believe there are benefits that can be obtained by ordering 
professionals, furnishing professionals and facilities, beneficiaries 
and technology infrastructure developers including qualified CDSM 
developers, EHR systems developers, and medical billing practices. We 
describe these estimated benefits in more detail in the following 
sections.
(1) Estimates of Savings
    It has been suggested that one-third of imaging procedures are 
inappropriate, costing the United States between $3 billion and $10 
billion annually \52\ (Stein, 2003). Data derived from the CCW 2014 
Part B non-institutional claim line file, which includes services 
covered by the Part B benefit that were furnished during CY 2014, 
identified approximately $3,300,000,000 in total payments for advanced 
diagnostic imaging services. If implementation of this program led to a 
30 percent decrease in total payments, then we would expect 
$990,000,000 in fewer payments annually. To address this suggestion, 
the insertion of a pause in the ordering workflow to introduce AUC is a 
potentially beneficial and cost-effective solution. Some believe \53\ 
that savings could be achieved through the reduction of inappropriate 
orders, and expenses associated with radiology benefit managers (Hardy, 
2010). Indeed, the Institute for Clinical Systems Improvement in 
Bloomington, Minnesota, performed a clinical decision support pilot 
project \54\ to (1) improve the utility of diagnostic radiology tests 
ordered, (2) reduce radiation exposure, (3) increase efficiency, (4) 
aid in shared decision making, and (5) save Minnesota $84,000,000 in 3 
years (Miliard, 2010). It is hypothesized \55\ that these benefits are 
the result of educating ordering professionals on the appropriate test 
for a set of clinical symptoms, rather than just adding time and 
electronic obstacles between ordering physicians and advanced 
diagnostic imaging services (Sistrom et al., 2009) as such transfer of 
knowledge can alter clinical practice.
---------------------------------------------------------------------------

    \52\ Stein C. Code red: Partners program aims to rein in 
skyrocketing costs of diagnostic imaging. Boston Globe, 2003.
    \53\ Hardy, K. Decision Support for Rad Reports. Radiology 
Today. Vol. 11, No. 1, p. 16., 2010.
    \54\ Miliard, M. Nuance, ICSI aim to prevent unnecessary imaging 
tests. Healthcare IT News. November 10, 2010.
    \55\ Sistrom CL, Dang PA, Weilburg JB, et al., Effect of 
Computerized Order Entry with Integrated Decision Support on the 
Growth of Outpatient Procedure Volumes: Seven-year Time Series 
Analysis. Radiology. 251(1), 2009.
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    The Center for Health Care Solutions at Virginia Mason Medical 
Center in Seattle, Washington examined approaches to control imaging 
utilization, including external authorization methods and clinical 
decision support systems. A retrospective cohort study \56\ was 
performed by Blackmore and colleagues in 2011 of the staged 
implementation of evidence-based clinical decision support for the 
following advanced diagnostic imaging services: Lumbar MRI; brain MRI; 
and sinus CT. Brain CT was included as a control. The number of 
patients imaged as a proportion of patients with selected clinical 
conditions before and after the decision support interventions were 
determined from billing data from a regional health plan and from 
institutional radiology information systems. The imaging utilization 
rates after the implementation of clinical decision support resulted in 
decreases for lumbar MRI (p-value = 0.001), head MRI (p-value = 0.05), 
and sinus CT (p-value = 0.003), while a decrease in control service 
head CT was not statistically significant (p-value = 0.88). Although 
there are limitations to this retrospective claims data analysis, the 
authors concluded that clinical decision support is associated with 
large decreases in the inappropriate utilization of advanced diagnostic 
imaging services.
---------------------------------------------------------------------------

    \56\ Blackmore, CC; Mecklenburg, RS; Kaplan GS. Effectiveness of 
Clinical Decision Support in Controlling Inappropriate Imaging. 
Journal of the American College of Radiology. 8(1) 2011.
---------------------------------------------------------------------------

    It seems reasonable from this and other studies \57\ of local 
implementation of clinical decision support (Curry and Reed, 2011; Ip 
et al., 2012) to assume that there may be some savings when regulations 
become effective January 1, 2020; however, there are also a few 
hesitations to extrapolating these and other findings broadly to the 
Medicare population. First, ordering professionals in this program are 
aware that CMS will pay for advanced diagnostic imaging services that 
do not adhere to the specified applicable AUC consulted. This awareness 
may impact the level of interest or extent of behavior modification 
from exposing ordering professionals to a qualified CDSM. Second, the 
statute distinguishes between the ordering professional, furnishing 
professional and facility, recognizing that the professional who orders 
an applicable imaging service is usually not the same professional or 
facility reporting to Medicare for that service when furnished. As a 
result, some ordering professionals may believe that since they are not 
required to submit AUC consultation information directly to CMS, there 
are no direct consequences of adhering to specified applicable AUC. 
Third, many advanced diagnostic imaging services may not have relevant 
or applicable AUC. Indeed a recent study \58\ implementing CDS was only 
able to prospectively generate a score for 26 percent and 30 percent of 
requests for advanced diagnostic imaging services before and after 
implementation of decision support, respectively (Moriarity et al., 
2015). Without AUC available, there can be no decision support 
intervention into the workflow of the ordering professional. Fourth, 
even when an ordering professional identifies an advanced diagnostic 
imaging service recognized as adhering to specified applicable AUC from 
one qualified PLE, discordance between AUC from different specialty 
societies has been reported \59\

[[Page 36056]]

(Winchester et al., 2016), suggesting that full benefits and savings 
cannot be realized without standard levels of appropriateness. Taken 
together, these concerns will form the basis for our continued 
examination of the impact of this and future rulemaking to maximize the 
benefits of this program.
---------------------------------------------------------------------------

    \57\ Curry, L. and Reed, M.H. Electronic decision support for 
diagnostic imaging in a primary care setting. J Am Med Inform Assoc. 
2011; 18: 267-270; Ip, I.K., Schneider, L.I., Hanson, R. et al. 
Adoption and meaningful use of computerized physician order entry 
with an integrated clinical decision support system for radiology: 
Ten-year analysis in an urban teaching hospital. J Am Coll Radiol. 
2012; 9: 129-136.
    \58\ Moriarity, AK, Klochko C, O'Brien M, Halabi S. The Effect 
of Clinical Decision Support for Advanced Inpatient Imaging. Journal 
of American College of Radiology. 12(4) 2015.
    \59\ Winchester DE et al., Discordance Between Appropriate Use 
Criteria for Nuclear Myocardial Perfusion Imaging from Different 
Specialty Societies: A potential concern for health policy. JAMA 
Cardiol. 1(2) 2016:207-210.
---------------------------------------------------------------------------

(2) Benefits to Medicare Beneficiaries
    Although qualified CDSMs are not required to demonstrate that their 
tools provide measurable benefits, we believe that as a result of 
installation and use, some ordering professionals may find benefits to 
the patients they serve. For example, if a qualified CDSM creates a 
flag or alert to obsolete tests, then the patient will benefit from 
avoiding unnecessary testing. The same outcome would be likely if a 
qualified CDSM implemented algorithms that recognize advanced 
diagnostic imaging services that may produce inaccurate results because 
of medications being taken by the patient. In addition, if the CDSM 
provides standardized processes for advanced diagnostic imaging orders 
or clarification for confusing test names, then the patient benefits 
from a potential decrease in medical errors. Finally, we believe it is 
reasonable to assume that some improvements in shared decision making 
could result from use of a qualified CDSM, because some CDSMs could 
provide cost information associated with advanced diagnostic imaging 
services and/or identify situations of repeated testing.
5. Medicaid Promoting Interoperability Program Requirements for 
Eligible Professionals Medicaid Promoting Interoperability Program 
Requirements for Eligible Professionals (EPs)
    In the Medicaid Promoting Interoperability Program, to keep eCQM 
specifications current and minimize complexity, we are proposing to 
align the eCQMs available for Medicaid EPs in 2019 with those available 
for MIPS eligible clinicians for the CY 2019 performance period. We 
anticipate that this proposal would reduce burden for Medicaid EPs by 
aligning the requirements for multiple reporting programs, and that the 
system changes required for EPs to implement this change would not be 
significant as many EPs are expected to report eCQMs to meet the 
quality performance category of MIPS and therefore should be prepared 
to report on those eCQMs for 2019. We expect that this proposal would 
have only a minimal impact on states, by requiring minor adjustments to 
state systems for 2019 to maintain current eCQM lists and 
specifications. State expenditures to make any systems changes required 
as a result of this proposal would be eligible for ninety percent 
enhanced Federal financial participation.
    For 2019, we are proposing that Medicaid EPs would report on any 
six eCQMs that are relevant to the EP's scope of practice, including at 
least one outcome measure, or if no applicable outcome measure is 
available or relevant, at least one high priority measure, regardless 
of whether they report via attestation or electronically. This policy 
would generally align with the MIPS reporting requirement for providers 
using the eCQM collection type for the quality performance category, 
which is established in Sec.  414.1335(a)(1). We are also proposing 
that the eCQM reporting period for EPs in the Medicaid Promoting 
Interoperability Program would be a full CY in 2019 for EPs who have 
demonstrated meaningful use in a prior year, in order to align with the 
corresponding performance period for the quality performance category 
in MIPS. We continue to align Medicaid Promoting Interoperability 
Program requirements with requirements for other CMS quality programs, 
such as MIPS, to the extent practicable, to reduce the burden of 
reporting different data for separate programs.
    In order to help states to make incentive payments to Medicaid EPs 
by December 31, 2021, consistent with section 1903(t)(4)(A)(iii) of the 
Act, we are proposing to amend Sec.  495.4 to provide that the EHR 
reporting period in 2021 for all EPs in the Medicaid Promoting 
Interoperability Program would be a minimum of any continuous 90-day 
period within CY 2021, provided that the end date for this period falls 
before October 31, 2021, to help ensure that the state can issue all 
Medicaid Promoting Interoperability Payments on or before December 31, 
2021. Similarly, we are proposing to change the eCQM reporting period 
in 2021 for EPs in the Medicaid Promoting Interoperability Program to a 
minimum of any continuous 90-day period within CY 2021, provided that 
the end date for this period falls before October 31, 2021, to help 
ensure that the state can issue all Medicaid Promoting Interoperability 
Payments on or before December 31, 2021.
    We are proposing to allow states the flexibility to set 
alternative, earlier final deadlines for EHR or eCQM reporting periods 
for Medicaid EPs in CY 2021, with prior approval from CMS, through 
their State Medicaid HIT Plan (SMHP). Providing states with the 
flexibility to set an alternative, earlier last possible date for the 
EHR or eCQM reporting period for Medicaid EPs in 2021 would make it 
easier for states to ensure that all payments are made by the December 
31, 2021 deadline, especially for states whose prepayment process may 
take longer than the 61 days provided by an October 31, 2021 deadline. 
We expect that this proposal would have only a minimal impact on 
states, by requiring minor adjustments to state systems to meet 
specifications for the proposed reporting periods, especially because 
we are also proposing to permit states to set a different end date for 
all EHR and eCQM reporting periods for Medicaid EPs in 2021. As 
previously noted, state expenditures for any systems changes required 
as a result of this proposal would be eligible for 90 percent enhanced 
Federal financial participation.
    Finally, we are proposing changes to the EP Meaningful Use 
Objective 6, (Coordination of care through patient engagement) Measure 
1 (View, Download, or Transmit) and Measure 2 (Secure Electronic 
Messaging), and to EP Meaningful Use Objective 8, Measure 2 (Syndromic 
surveillance reporting). We are proposing to amend these measures in 
response to feedback about the burdens they create for EPs seeking to 
demonstrate meaningful use, and about how they may not be fully aligned 
with how states and public health agencies collect syndromic 
surveillance data. These proposed amendments are expected to reduce 
provider burden. Again, we expect that any changes these proposals 
might require to state systems would be minimal and that state 
expenditures to make any such changes would also be eligible for 90 
percent enhanced federal financial participation.
6. Medicare Shared Savings Program
    We are proposing certain modifications to our rules regarding 
quality measures. Specifically we are proposing: (1) A policy to add 
two Patient of Care Experience Survey measures, and (2) a policy to 
remove four claims-based outcome measures. Both of these proposed 
policies are generally expected to have a minimal impact on affected 
ACOs. We do not anticipate any overall impact for these proposed 
policies because potential individual ACO impacts are more likely to 
offset one another rather than build to a substantial total in terms of 
costs or savings.

[[Page 36057]]

7. Physician Self-Referral Law
    The physician self-referral law provisions are discussed in section 
III.G. of this proposed rule. We are proposing regulatory updates to 
implement the provisions of section 50404 of the Bipartisan Budget Act 
of 2018 pertaining to the writing and signature requirements in certain 
compensation arrangement exceptions to the statute's referral and 
billing prohibitions. The proposed regulatory language for the writing 
requirement reflects current policy, so we do not anticipate that it 
would have an impact. We expect that the proposal regarding temporary 
non-compliance with signature arrangements would reduce burden by 
giving parties additional time to obtain all required signatures.
8. Changes Due to Updates to the Quality Payment Program
    In section III.H. of this proposed rule, we included our proposals 
for the Quality Payment Program. In this section of the proposed rule, 
we present the overall and incremental impacts to the expected QPs and 
associated APM incentive payments. In MIPS, we analyze the total impact 
and incremental impact of statutory changes to eligibility from the 
Bipartisan Budget Act of 2018 as well as proposals to expand MIPS 
eligibility by expanding the MIPS eligible clinician definition and 
adding a third criterion for the low-volume threshold and an opt-in 
policy option for any clinician that exceeds at least one, but not all, 
of the low-volume threshold criteria. Finally, we estimate the payment 
impacts by practice size based on various proposals to modify the MIPS 
final score, proposals for the performance threshold and additional 
performance threshold, and as required by the Bipartisan Budget Act of 
2018, the impact of applying the MIPS payment adjustments to covered 
professional services (services for which payment is made under, or is 
based on,the Physician Fee Schedule and that are furnished by an 
eligible clinician) rather than items and services covered under Part 
B.
    The submission period for the first MIPS performance period ended 
in early 2018, however, the final data sets were not available in time 
to incorporate into this analysis. If technically feasible, we intend 
to use data from the CY 2017 MIPS performance period in the final rule.
a. Estimated Incentive Payments to QPs in Advanced APMs and Other Payer 
Advanced APMs
    From 2019 through 2024, through the Medicare Option, eligible 
clinicians receiving a sufficient portion of Medicare Part B payments 
for covered professional services or seeing a sufficient number of 
Medicare patients through Advanced APMs as required to become QPs would 
receive a lump-sum APM Incentive Payment equal to 5 percent of their 
estimated aggregate payment amounts for Medicare covered professional 
services in the preceding year. In addition, beginning in payment year 
2021, in addition to the Medicare Option, eligible clinicians may 
become QPs through the All-Payer Combination Option. The All-Payer 
Combination Option will allow eligible clinicians to become QPs by 
meeting the QP thresholds through a pair of calculations that assess a 
combination of both Medicare Part B covered professional services 
furnished through Advanced APMs and services furnished through Other 
Payer Advanced APMs.
    The APM Incentive Payment is separate from and in addition to the 
payment for covered professional services furnished by an eligible 
clinician during that year. Eligible clinicians who become QPs for a 
year would not need to report to MIPS and would not receive a MIPS 
payment adjustment to their Part B physician fee schedule payments. 
Eligible clinicians who do not become QPs, but meet a slightly lower 
threshold to become Partial QPs for the year, may elect to report to 
MIPS and would then be scored under MIPS and receive a MIPS payment 
adjustment, but do not receive the APM Incentive Payment. For the 2019 
Medicare QP Performance Period, we define Partial QPs to be eligible 
clinicians in Advanced APMs who have at least 40 percent, but less than 
50 percent, of their payments for Part B covered professional services 
through an Advanced APM Entity, or furnish Part B covered professional 
services to at least 20 percent, but less than 35 percent, of their 
Medicare beneficiaries through an Advanced APM Entity. If the Partial 
QP elects to be scored under MIPS, they would be subject to all MIPS 
requirements and would receive a MIPS payment adjustment. This 
adjustment may be positive, negative or neutral. If an eligible 
clinician does not meet either the QP or Partial QP standards, the 
eligible clinician would be subject to MIPS, would report to MIPS, and 
would receive the corresponding MIPS payment adjustment.
    Beginning in 2026, payment rates for services furnished by 
clinicians who achieve QP status for a year would be increased each 
year by 0.75 percent for the year, while payment rates for services 
furnished by clinicians who do not achieve QP status for the year would 
be increased by 0.25 percent. In addition, MIPS eligible clinicians 
would receive positive, neutral, or negative MIPS payment adjustments 
to payment for their Part B physician fee schedule services in a 
payment year based on performance during a prior performance period. 
Although MACRA amendments established overall payment rate and 
procedure parameters until 2026 and beyond, this impact analysis covers 
only the third payment year (2021 MIPS payment year) of the Quality 
Payment Program in detail.
    In section III.H.4.g.(4)(b) of this proposed rule, we propose to 
add a third alternative to allow requests for QP determinations at the 
TIN level in instances where all clinicians who have reassigned billing 
rights under the TIN participate in a single APM Entity. This option 
would therefore be available to all TINs participating in Full TIN 
APMs, such as the Medicare Shared Savings Program. It would also be 
available to any other TIN for whom all clinicians who have reassigned 
billing rights to the TIN are participating in a single APM Entity. We 
are further proposing that this third alternative will only be 
available to eligible clinicians who meet the Medicare threshold at the 
APM Entity level; it will not be available for eligible clinicians who 
meet the Medicare threshold individually.
    In section III.H.4.g.(4)(c)(ii), we also propose to extend the same 
weighting methodology to TIN level Medicare Threshold Scores in 
situations where a TIN is assessed under the Medicare Option as part of 
an APM Entity group, and receives a Medicare Threshold Score at the APM 
Entity group level. In this scenario, we believe that the Medicare 
portion of the TIN's All-Payer Combination Option Threshold Score 
should not be lower than the Medicare Threshold Score that they 
received by participating in an APM Entity group (82 FR 53881 through 
53882). We note this extension of the weighting methodology would only 
apply to a TIN when that TIN represents a subset of the eligible 
clinicians in the APM Entity, because when the TIN and the APM Entity 
are the same there is no need for this weighted methodology. We propose 
to calculate the TIN's QP Threshold Scores both on its own and with 
this weighted methodology, and then use the most advantageous score 
when making a QP determination. We believe that, as

[[Page 36058]]

it does for QP determinations made at the APM Entity level, this 
approach promotes consistency between the Medicare Option and the All-
Payer Combination Option to the extent possible. Additionally, the 
proposed application of this weighting approach in the case of a TIN 
level QP determination would be consistent with our established policy.
    These proposals affect the estimated number of QPs for the 2021 
payment year. We estimate that approximately 8,100 additional eligible 
clinicians in 8 TINs would become QPs if these policies are finalized 
representing TIN level QP determinations under the All-Payer 
Combination Option. Therefore, they would be excluded from MIPS, and 
qualify for the lump sum incentive payment based on 5 percent of their 
Part B allowable charges for covered professional services, which are 
estimated to be approximately $545 million in the 2019 performance 
year. We also estimate the corresponding increase of the APM incentive 
payment of 5 percent of Part B allowed charges for QPs would be 
approximately $27 million for the 2021 payment year.
    Overall, we estimate that between 160,000 and 215,000 eligible 
clinicians would become QPs, therefore be excluded from MIPS, and 
qualify for the lump sum incentive payment based on 5 percent of their 
Part B allowable charges for covered professional services in the 
preceding year, which are estimated to be between approximately $12,000 
million and $16,000 million in total for the 2019 performance year. We 
estimate that the aggregate total of the APM incentive payment of 5 
percent of Part B allowed charges for QPs would be between 
approximately $600 and $800 million for the 2021 payment year.
    We project the number of eligible clinicians that will be QPs, and 
thus excluded from MIPS, using several sources of information. First, 
the projections are anchored in the most recently available public 
information on Advanced APMs. The projections reflect Advanced APMs 
that will be operating during the 2019 QP performance period, as well 
as Advanced APMs anticipated to be operational during the 2019 QP 
performance period. The projections also reflect an estimated number of 
eligible clinicians that would attain QP status through the All-Payer 
Combination Option. The following APMs are expected to be Advanced APMs 
in performance year 2019, including the Next Generation ACO Model, 
Comprehensive Primary Care Plus (CPC+) Model, Comprehensive ESRD Care 
(CEC) Model (Two-Sided Risk Arrangement), Vermont All-Payer ACO 
Model,\60\ Comprehensive Care for Joint Replacement Payment Model 
(CEHRT Track), Oncology Care Model (Two-Sided Risk Arrangement), 
Medicare ACO Track 1+ Model, Bundled Payment for Care Improvement 
Advanced, Maryland Total Cost of Care Model (Maryland Care Redesign 
Program; Maryland Primary Care Program), and the Shared Savings Program 
Tracks 2 and 3. We used the APM Participant Lists (see 81 FR 77444 
through 77445 for information on the APM participant lists and QP 
determination) on the most recent MDM provider extract for the 
Predictive QP determination file for 2018 QP performance period to 
estimate QPs for the 2019 QP performance period. We examine the extent 
to which Advanced APM participants would meet the QP thresholds of 
having at least 50 percent of their Part B covered professional 
services or at least 35 percent of their Medicare beneficiaries 
furnished Part B covered professional services through the Advanced APM 
Entity.
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    \60\ Vermont ACOs will be participating in an Advanced APM 
during 2018 through a modified version of the Next Generation ACO 
Model. The Vermont Medicare ACO Initiative is expected to be an 
Advanced APM beginning in 2019.
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b. Estimated Number of Clinicians Eligible for MIPS Eligibility
(1) Summary of Proposals Related to MIPS Eligibility and Application of 
MIPS Payment Adjustments
    We are making three sets of proposed policy changes that would 
impact the number of MIPS eligible clinicians starting with CY 2019 
MIPS performance period and the CY 2021 MIPS payment year. Two of the 
proposed changes affect the low-volume threshold and the third affects 
the definition of a MIPS eligible clinician. We briefly describe each 
of these changes later in this section.
    First, in section III.H.3.c.(2) of this proposed rule, we proposed 
changes to our policy to comply with the Bipartisan Budget Act of 2018. 
Specifically, we are proposing to update the low-volume threshold 
starting with the 2020 MIPS payment year to be based on covered 
professional services (services for which payment is made under, or is 
based on the Physician Fee Schedule and that are furnished by an 
eligible clinician) rather than items and services covered under Part 
B, as provided in section 1848(q)(1)(B) as amended by section 
51003(a)(1)(A)(i) of the Bipartisan Budget Act of 2018. This proposal 
may affect the previously finalized calculation for the low-volume 
threshold for certain clinicians because payment for items, such as 
Part B drugs, which were previously considered in the low-volume 
determination, are now excluded. In addition, section 51003(a)(1)(E) of 
the Bipartisan Budget Act of 2018 revised section 1848(q)(6)(E) to 
apply the MIPS payment adjustments to covered professional services 
rather than to items and services covered under Part B. This change is 
effective with the 2019 MIPS payment year. Its effect on the amount of 
payment adjustments under MIPS is included in this analysis.
    Second, in section III.H.3.a. of this proposed rule, beginning with 
the 2021 MIPS payment year, we are proposing to expand the definition 
of MIPS eligible clinicians to include physical therapists, 
occupational therapists, clinical social workers, and clinical 
psychologists. Specifically, we are proposing to define as a MIPS 
eligible clinician, as identified by a unique billing TIN and NPI 
combination used to assess performance, as any of the following: A 
physician (as defined in section 1861(r) of the Act); a physician 
assistant, nurse practitioner, and clinical nurse specialist (as such 
terms are defined in section 1861(aa)(5) of the Act); a certified 
registered nurse anesthetist (as defined in section 1861(bb)(2) of the 
Act), a physical therapist, an occupational therapist, a clinical 
social worker, and a clinical psychologist; and a group that includes 
such clinicians.
    Third, as discussed in sections III.H.3.c.(4) and III.H.3.c.(5) of 
this proposed rule, in addition to the amendments to comply with 
Bipartisan Budget Act of 2018, we are proposing to modify our 
definition of the low-volume threshold by adding a third criterion (for 
``covered professional services''). If this proposal is finalized, the 
low-volume threshold would now include a third criterion: Set at 200 
covered professional services to Part B-enrolled individuals. Taken 
together, if this proposal is finalized, the low-volume threshold would 
be as follows: (1) Those with $90,000 or less in allowed charges for 
covered professional services; or (2) 200 or fewer Part B-enrolled 
individuals who are furnished Medicare physician fee schedule services; 
or (3) 200 or fewer covered professional services. The low volume 
threshold assessment is applied at the TIN/NPI level for individual 
reporting, the TIN level for group reporting, or the APM Entity Level 
for reporting under the APM scoring standard. We are further proposing 
any clinician who exceeds the low-volume threshold on at least one, but 
not all three, low-volume threshold criteria may elect to opt-in to 
MIPS to be

[[Page 36059]]

measured on performance, thereby qualifying to receive a positive, 
neutral, or negative MIPS payment adjustment based on performance. The 
absence of of the opt-in within this cohort means they are not MIPS 
eligible clinicians. If a MIPS eligible clinician does not meet at 
least one of these low-volume criteria, they are excluded from MIPS. 
For purposes of this impact analysis we refer to these revisions to the 
low-volume threshold and its application collectively as the ``opt-in 
policy''.
    We discuss how these three proposed changes impact MIPS eligibility 
and payments, later in this section.
(2) Methodology To Assess MIPS Eligibility
(a) Clinicians Included in the Model Prior to Low-Volume Threshold
    To estimate the number of clinicians for the CY 2019 performance 
period, our scoring model used the CY 2019 MIPS payment year 
eligibility file as described in the CY 2017 Quality Payment Program 
Final Rule (81 FR 77069 through 77070). We included 1.5 million 
clinicians (see Table 96) who had Physician Fee Schedule claims from 
September 1, 2015 to August 31, 2016 and included a 60-day claim run-
out. We used data from September 1, 2015 to August 31, 2016 to maximize 
the overlap with the performance data in our model.
    We assessed covered professional services (services for which 
payment is made under, or is based on the Physician Fee Schedule and 
that are furnished by an eligible clinician) \61\ to understand the 
incremental impact of basing the low-volume threshold on covered 
professional services rather than all items and services under Part B.
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    \61\ The date range for these covered professional services is 
September 1, 2016 to August 31, 2017.
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    Clinicians are ineligible for MIPS (and are excluded from MIPS 
payment adjustment) if they are newly enrolled to Medicare; are QPs; 
are partial QPs who elect to not participate in MIPS; are not one of 
the clinician types included in the definition for MIPS eligible 
clinician; or do not exceed the low-volume threshold. Therefore, we 
excluded these clinicians when calculating those clinicians eligible 
for MIPS. For our baseline population, we restricted to clinicians who 
are a physician (as defined in section 1861(r) of the Act); a physician 
assistant, nurse practitioner, and clinical nurse specialist (as such 
terms are defined in section 1861(aa)(5) of the Act); a certified 
registered nurse anesthetist (as defined in section 1861(bb)(2) of the 
Act). For the proposed MIPS eligible population for the CY 2021 MIPS 
payment year, we add in clinicians who are physical therapists, 
occupational therapists, clinical social workers, and clinical 
psychologists.
    As noted previously, we excluded QPs from our scoring model, since 
these clinicians are not eligible for MIPS. To determine which QPs 
should be excluded, we used the APM Participation List for the third 
snapshot date of the 2017 QP performance period because these data were 
available by TIN and NPI and could be merged into our model. We assumed 
that all partial QPs would participate in MIPS and included them in our 
scoring model and eligibility counts. The estimated number of QPs 
excluded from our model is lower than the projected number of QPs 
(160,000 to 215,000) for the 2019 QP performance period due to the 
expected growth in APM participation. Due to data limitations, we 
cannot identify specific clinicians who may become QPs in the 2019 
Medicare QP Performance Period; hence, our model may overestimate the 
fraction of clinicians and allowed charges for covered professional 
services that will remain subject to MIPS after the exclusions.
    We also excluded newly enrolled Medicare clinicians from our model. 
To identify newly enrolled Medicare clinicians, we continued the 
assumption applied in the CY 2018 Quality Payment Program final rule 
that clinicians (NPIs) are newly enrolled if they have Physician Fee 
Schedule charges in the eligibility file but no Physician Fee Schedule 
charges in 2015. This newly enrolled modeling methodology attempts to 
simulate those newly enrolled, but does not exactly match the policies 
finalized under Sec. Sec.  414.1305 and 414.1310 which uses information 
from the Provider Enrollment, Chain and Ownership System (PECOS and 
previous claims submissions).
    We also excluded a small percentage of clinicians (20,411) for whom 
we have limited performance data. Although these clinicians may in fact 
be eligible for MIPS, we did not have sufficient data to estimate 
performance.\62\
---------------------------------------------------------------------------

    \62\ We excluded clinicians that submitted via measures groups 
under the 2016 PQRS, since that data submission mechanism was 
eliminated under MIPS, and we did not anticipate being able to 
accurately predict performance. Additionally, we also excluded 
clinicians in the CPC model if we did not have their quality data.
---------------------------------------------------------------------------

    In section III.H.3.j.(4)(d) of the proposed rule, we propose to 
waive the payment consequences (positive, negative or neutral 
adjustments) of MIPS and to waive the associated MIPS reporting 
requirements adopted to implement the payment consequences for certain 
participating clinicians in the MAQI Demonstration subject to 
conditions outlined in the Demonstration, starting with the 2020 MIPS 
payment period. Removing eligible clinicians from MIPS may affect the 
payment adjustments for other MIPS eligible clinicians in each year the 
waiver is offered. However, we are unable to identify the specific TIN/
NPIs in our model would be affected by this proposal; therefore, we are 
unable to account for this proposal in the eligibility or payment 
adjustment tables.
(b) Assumptions Related to the Low-Volume Threshold
    The low-volume threshold policy may be applied at the individual 
(that is, TIN/NPI) or group (that is, TIN or APM entity) levels based 
on how data are submitted. If no data are submitted, then the low-
volume threshold is applied at the TIN/NPI level. We also propose that 
a clinician or group that exceeds at least one but not all three low-
volume threshold criteria may become MIPS eligible by submitting data 
to MIPS and electing to opt-in, thereby getting measured on performance 
and receiving a MIPS payment adjustment.
    For the purposes of modeling, we made assumptions on group 
reporting to apply the low-volume threshold. One extreme and unlikely 
assumption is that no practices elect group reporting and the low-
volume threshold would always be applied at the individual level. 
Although we believe a scenario in which only these clinicians would 
participate as individuals is unlikely, this assumption is important 
because it quantifies the minimum number of MIPS eligible clinicians. 
For the model, we estimate there are approximately 218,000 clinicians 
who would be MIPS eligible because they exceed the low volume threshold 
as individuals and are not otherwise excluded. In Table 96, we identify 
clinicians under this assumption as having ``required eligibility.''
    Based on historic data, we anticipate that group and APM Entities 
will submit data to MIPS. Therefore, if we revise our model's group 
reporting assumption such that all clinicians that were participating 
in ACOs in 2016 (including ACOs participating under the Shared Savings 
Program, Pioneer ACO Model, or Next Generation ACO Model) or who 
reported to 2016 PQRS as a group would continue to do so in MIPS, then 
the MIPS eligible clinician population would increase by almost 390,000 
clinicians for a total MIPS eligible population of approximately 
608,000. In Table 96, we identify these

[[Page 36060]]

clinicians who do not meet the low-volume threshold individually but 
are anticipated to submit to MIPS as a group based on previous 
participation in legacy programs as having ``group eligibility.''

  Table 96--Description of MIPS Eligibility Status for CY 2021 MIPS Payment Year Using the Proposed Assumptions
                                                       ***
----------------------------------------------------------------------------------------------------------------
                                                                                                    Cumulative
              Eligibility status                 Predicted participation status      Number of       number of
                                                   in MIPS among clinicians *       clinicians      clinicians
----------------------------------------------------------------------------------------------------------------
Required eligibility (always subject to a MIPS  Participate in MIPS.............         186,549         186,549
 payment adjustment because individual          Do not participate in MIPS......          31,921         218,470
 clinicians exceed the low-volume threshold in
 all 3 criteria).
Group eligibility (only subject to payment      Submit data as a group..........         389,670         608,140
 adjustment because clinicians' groups exceed
 low-volume threshold in all 3 criteria and
 submit as a group).
Opt-In eligibility (only subject to a           Elect to opt-in and submit data.          42,025      ** 650,165
 positive, neutral, or negative adjustment
 because the individual or group exceeds the
 low-volume threshold in at least 1 criterion
 but not all 3, and they elect to opt-in to
 MIPS and submit data).
Not MIPS eligible:
    Potentially MIPS eligible (not subject to   Do not opt-in; or Do not submit          482,574       1,132,739
     payment adjustment for non-participation;   as a group.
     could be eligible for one of two reasons:
     (1) Meet group eligibility or (2) opt-in
     eligibility criteria).
    Below the low-volume threshold (never       Not applicable..................          88,070       1,220,809
     subject to payment adjustment; both
     individual and group is below all 3 low-
     volume threshold criteria).
    Excluded for other reasons (Non-eligible    Not applicable..................         302,172       1,522,981
     clinician type, newly-enrolled, QP).
----------------------------------------------------------------------------------------------------------------
* Participation in MIPS defined as previously submitting quality or EHR data for PQRS. Our assumptions for group
  reporting are based on 2016 PQRS group reporting.
** Estimated MIPS Eligible Population.
*** Facility-based eligible clinicians are not modeled separately in this table and are captured in the
  individual eligible category. This table does not consider the impact of the MAQI Demonstration waiver.

    To model the proposed opt-in policy, we assumed that 33 percent of 
the clinicians who exceed at least one low-volume threshold and 
submitted data to 2016 PQRS would elect to opt-in to MIPS. We selected 
a random sample of 33 percent of clinicians without accounting for 
performance or investment in quality reporting. We believe this 
assumption of 33 percent is reasonable because some clinicians may 
choose not to submit data due to performance, practice size, or 
resources or alternatively, some may submit data, but elect to be a 
voluntary reporter and not be subject to a MIPS payment adjustment 
based on their performance. We seek comment on these assumptions, 
including whether modeling eligibility only among clinicians or groups 
who submitted at least 6 quality measures to PQRS would be more 
appropriate. This 33 percent participation assumption is identified in 
Table 96 as ``Opt-In eligibility''. We estimate an additional 42,000 
clinicians would be eligible through this policy for a total MIPS 
eligible population of approximately 650,000.
    There are approximately 482,000 clinicians who are not MIPS 
eligible, but could be if their practice decides to participate. We 
describe this group as ``Potentially MIPS eligible.'' This is the 
unlikely scenario in which all group practices elect to submit data as 
a group and all clinicians that could elect to opt-into MIPS do elect 
to opt-in. This assumption is important because it quantifies the 
maximum number of MIPS eligible clinicians. When this unlikely scenario 
is modeled, we estimate that the MIPS eligible clinician population 
could be as high as 1.1 million clinicians.
    Finally, there are some clinicians who would not be MIPS eligible 
either because they are below the low-volume threshold on all three 
criteria (approximately 88,000) or because they are excluded for other 
reasons (approximately 302,000).
    Since eligibility among some clinicians is contingent on submission 
to MIPS, we will not know the exact number of MIPS eligible clinicians 
until the submission period for the CY 2019 MIPS performance period is 
closed. For this impact analysis, we are using the estimated population 
of 650,165 MIPS eligible clinicians described above.
(3) Impact of MIPS Eligibility Proposals
    We illustrate in Table 97 how each proposed policy for the CY 2021 
payment year affects the estimated number of MIPS eligible clinicians. 
In the CY 2018 Quality Payment Program final rule, 604,006 MIPS 
eligible clinicians were included in our scoring model (82 FR 53930). 
After updating the population to exclude the additional QPs identified 
in the 2017 performance period final QP file, the new baseline 
population is 591,010. All incremental impact estimates are relative to 
this baseline.

[[Page 36061]]



                                              Table 97--Incremental Change Table for 2021 MIPS Payment Year
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             Estimated       Estimated
                                                          number of MIPS     effect of
                                                             eligible     policy changes    Estimated %   Estimated Part   Estimated PFS    Estimated %
                    Policy changes *                        clinicians     on number of     change from    B amount paid    amount paid    change in PFS
                                                            impacted by    MIPS eligible     baseline          (mil)           (mil)       from baseline
                                                           policy change    clinicians
--------------------------------------------------------------------------------------------------------------------------------------------------------
Baseline: Applying previously finalized policy..........             N/A         591,010             N/A          54,748          45,163             N/A
Policy Change 1: Low-volume threshold (LVT)                       -1,173         589,837            -0.2             N/A          45,101            -0.1
 determination based on covered professional services
 (as required by Bipartisan Budget Act of 2018).........
Policy Change 2: Expansion of eligible clinician types            18,303         608,140             2.9             N/A          45,831             1.5
 to include physical therapists, occupational
 therapists, clinical social workers, and clinical
 psychologists based with policy change 1...............
Policy Change 3: Cumulative change of Opt-in Policy with          42,025         650,165            10.0             N/A          47,401             5.0
 policy changes 1 and 2.................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
* This table does not consider the impact of the MAQI Demonstration waiver.

    First, as shown in Table 97, the first row shows the effect of 
changing the application of the MIPS payment adjustments, as required 
by section 51003(a)(1)(E) of the Bipartisan Budget Act of 2018 to apply 
them to covered professional services (services for which payment is 
made under, or is based on, the Medicare Physician Fee Schedule and are 
furnished by an eligible clinician) rather than to items and services 
covered under Part B. As shown, the baseline amount paid for Part B is 
$54.7 billion, compared with $45.1 billion in covered professional 
services, which is a difference of almost $10 billion. Under this 
change, the payment adjustments, beginning in the 2019 MIPS payment 
year, will only be applied to covered professional services.
    In Table 97, under the first policy change, basing the low-volume 
threshold on covered professional services (services provided under the 
physician fee schedule rather than items and services covered under 
Part B) has minimal impact in terms of clinicians (less than half of 
one percent decrease).
    When the second policy change, to expand the definition of MIPS 
eligible clinician types, was added to the first policy change, the 
total effect is small. The change in the potential MIPS eligible 
clinician population increased by less than 3 percent and the amount 
paid in the Physician Fee Schedule increased by 1.5 percent.
    When the third policy change, which implements the opt-in policy, 
is added to the other two policies, the estimated number of MIPS 
eligible clinicians increases by 10.0 percent. The estimated increase 
in the amount paid in the Physician Fee Schedule is 5.0 percent.
c. Estimated Impacts on Payments to MIPS Eligible Clinicians
(1) Summary of Approach
    In sections III.H.3.h., III.H.3.i. and III.H.3.j. of this proposed 
rule, we are making several proposals which impact the measures and 
activities that impact the performance category scores, final score 
calculation, and the MIPS payment adjustment. We discuss these 
proposals in more detail in section VII.F.8.c.(2) as we describe our 
methodology to estimate MIPS payments for the 2021 MIPS payment year. 
We note that many of the MIPS policies from the CY 2018 Quality Payment 
Program final rule were only defined for the 2018 MIPS performance 
period and 2020 MIPS payment year (including the performance threshold, 
the additional performance threshold, the policy for redistributing the 
weights of the performance categories, and many scoring policies for 
the quality performance category) which precludes us from developing a 
baseline for the 2019 MIPS performance period and 2021 MIPS payment 
year if there were no new regulatory action. Therefore, our impact 
analysis looks at the total effect of the proposed MIPS policy changes 
on the MIPS final score and payment adjustment for CY 2019 MIPS 
performance period/CY 2021 MIPS payment year.
    The payment impact for an eligible clinician in MIPS is based on 
their final score, which is a value determined by their performance in 
the four MIPS performance categories: Quality, cost, improvement 
activities, and Promoting Interoperability.
    The performance and participation data submitted for the 2017 MIPS 
performance period were not available in time to estimate the final 
score and the projected payment adjustments for MIPS eligible 
clinicians in this proposed rule. Therefore, as discussed in section 
VII.F.8. of this proposed rule, we used the most recently available 
data from historic programs. We will use MIPS performance data for the 
final rule should that data become available.
    The estimated payment impacts presented in this proposed rule 
reflect averages by practice size based on Medicare utilization. The 
payment impact for a MIPS eligible clinician could vary from the 
average and would depend on the combination of services that the MIPS 
eligible clinician furnishes. The average percentage change in total 
revenues would be less than the impact displayed here because MIPS 
eligible clinicians generally furnish services to both Medicare and 
non-Medicare patients; this program does not impact payment from non-
Medicare patients. In addition, MIPS eligible clinicians may receive 
Medicare revenues for services under other Medicare payment systems, 
such as the Medicare Federally Qualified Health Center Prospective 
Payment System or Medicare Advantage that would not be affected by MIPS 
payment adjustment factors.
(2) Methodology To Assess Impact
    To estimate participation in MIPS for the CY 2019 Quality Payment 
Program for this proposed rule, we used data

[[Page 36062]]

from the 2016 Physician Quality Reporting System (PQRS) and the 
Medicare and Medicaid EHR Incentive Programs. Our scoring model 
includes the 650,165 estimated number of MIPS eligible clinicians as 
described in section VII.F.8.b of this proposed rule.
    To estimate the impact of MIPS on eligible clinicians, we used 
recently available data, including 2015 and 2016 PQRS data, 2015 and 
2016 CAHPS for PQRS data, 2016 Quality and Resource Use Reports (QRUR) 
and 2018 Value Modifier (VM) data, 2016 Medicare and Medicaid EHR 
Incentive Program data, data prepared to support the 2017 performance 
period initial determination of clinician and special status 
eligibility (available via the NPI lookup on qpp.cms.gov) \63\, the 
2017 published MIPS measure benchmarks, the APM Participation List for 
the third snapshot date of the 2017 QP performance period to identify 
QP clinicians, and other available data to model the scoring provisions 
described in this regulation. We calculated a hypothetical final score 
for each MIPS eligible clinician based on quality, cost, Promoting 
Interoperability, and improvement activities performance categories. 
Because we lack detailed performance information for virtual groups, we 
are unable to assess performance for virtual groups as an entity.
---------------------------------------------------------------------------

    \63\ The time period for this eligibility file (September 1, 
2015 to August 31, 2016) maximizes the overlap with the performance 
data in our model.
---------------------------------------------------------------------------

(a) Methodology To Estimate the Quality Performance Category Score
    We estimated the quality performance category score using measures 
submitted to PQRS for the 2016 performance period, the 2016 CAHPS for 
PQRS data, and the all-cause hospital readmissions measure from the 
2016 QRUR/2018 VM analytic file. For quality measures collected via 
claims, eCQMs, MIPS CQM, QCDR, and CMS-approved survey vendor 
collection types, we applied the published benchmarks developed for the 
2018 MIPS performance period. For quality measures collected and 
submitted via the CMS Web Interface, we applied the published 
benchmarks developed for the 2016/2017 reporting years for the Shared 
Savings Program where available, and did not calculate scores for 
measures for which Shared Savings Program benchmarks did not exist. For 
the all-cause hospital readmission measure, we used available published 
benchmark for CY 2017 MIPS performance period which is the most recent 
public benchmark available.
    We assigned measure achievement points as finalized in the CY 2017 
and CY 2018 Quality Payment Program final rules (81 FR 77282 and 82 FR 
53718) and as discussed in section III.H.3.i.(1)(b)(iii) of this 
proposed rule. As proposed in III.H.3.i.(1)(b)(iii)(A) of this proposed 
rule, we would continue to apply the 3-point floor for measures that 
cannot be reliably scored against a baseline benchmark in the 2019 MIPS 
performance period.
    In section III.H.3.h.(2)(b)(iii) of this proposed rule, we propose 
to remove many measures that were previously able to be reported in 
PQRS and in previous MIPS performance periods. For our estimates, we 
assumed that clinicians who reported claims, eCQM, MIPS CQM and QCDR 
measures that are proposed to be removed would find alternate measures; 
therefore, we assigned points to these measures and included them in 
our scoring model. For CY 2019, we maintained the policies for scoring 
measures that do not meet the quality category requirements (case 
minimum, benchmark, and data completeness) as described in the CY 2018 
Quality Payment Program final rule (82 FR 53727 through 53730). As 
finalized in the CY 2018 Quality Payment Program final rule, we also 
applied a 7-point cap for measures that are topped out for two or more 
years (82 FR 53726 through 53727).
    In section III.H.3.h.(2)(a)(iii)(A)(bb) of this proposed rule, we 
propose to remove several Web Interface measures. For that collection 
type, which has a standard set of measures, we estimated performance on 
the measures that we propose to continue.
    As proposed in sections III.H.3.i.(1)(b)(ix) and (x) of this 
proposed rule, we maintained the cap on bonus points for high-priority 
measures and end-to-end electronic bonus points at 10 percent of the 
denominator and, beginning with the 2019 MIPS performance period, 
discontinue high priority bonus points for CMS Web Interface Reporters. 
Because we are not able to use MIPS performance data in our models at 
this time, we continued our assumption in the CY 2018 Quality Payment 
Program final rule to assign the end-to-end electronic bonus: 1 point 
for every submitted eCQM and for each measure submitted via CMS Web 
Interface if the group indicated that they submitted using their EHR 
with a cap of 10 percent of the total possible measure achievement 
points. To be consistent with our small practice bonus proposal in 
section III.H.3.i.(1)(b)(viii) of this proposed rule, we added 3 
measure achievement points to the quality performance category score 
for small practices that had a quality performance category score 
greater than 0 points.
    As finalized in the CY 2018 Quality Payment Program final rule (82 
FR 53625 through 52626) and further discussed in III.H.3.h.(2)(a)(iii) 
of this proposed rule, we are allowing MIPS eligible clinicians and 
groups to submit data collected via multiple collection types within a 
performance category beginning with the 2019 performance period. The 
requirements for the performance categories remain the same regardless 
of the number of collection types used. We do not apply the validation 
process that is discussed in section III.H.3.i.(1)(b)(vii) of this 
proposed rule.
    To estimate the impact of improvement for the quality performance 
category, we estimated a quality performance category percent score 
using 2015 and 2016 PQRS data, 2015 and 2016 CAHPS for PQRS data, and 
2015 and 2016 QRUR data. For eligible clinicians with an estimated 
quality performance category score less than or equal to a 30 percent 
score in the previous year, we compared 2019 performance to an assumed 
2018 quality score of 30 percent for their improvement score as 
described in III.H.3.i.(1)(b)(xiii) of this proposed rule.
    Due to data limitations, we are unable to model all the policies 
proposed in this rule. We are not able to incorporate the policy to 
reduce the denominator for the quality performance category score by 10 
points for groups that registered for CAHPS for MIPS but were unable to 
report due to insufficient sample size as discussed in section 
III.H.3.i.(1)(b)(iii)(B) of this proposed rule. We also did not apply 
the proposed scoring policy for measures that are significantly 
impacted by clinical guideline or other changes discussed in section 
III.H.3.i.(1)(b)(vi) of this proposed rule.
    Our model applied the MIPS APM scoring standards proposed in 
section III.H.3.h.(6) of this proposed rule to quality data from MIPS 
eligible clinicians that participated in the Shared Savings Program, 
the Pioneer ACO Model, and the Next Generation ACO Model in 2016.
(b) Methodology To Estimate the Cost Performance Category Score
    In section III.H.3.h.(3)(b) of this proposed rule, we propose to 
add 8 episode-based measures. For the episode-based measures, we used 
the proposed episode specifications discussed in section 
III.H.3.h.(3)(b) of

[[Page 36063]]

this proposed rule and claims data from June 2016 through May 2017. We 
estimated the cost performance category score using the total per 
capita cost measure (TCPC) and Medicare Spending Per Beneficiary (MSPB) 
measures from the value modifier (VM) program, as that is the most 
recently available data, and the 8 newly developed episode-cost 
measures prepared for MIPS. The values of the 2 VM measures are those 
computed for the 2018 VM using data from calendar year 2016. Cost 
measure scores were used only when the associated case size met or 
exceeded the previously finalized or newly proposed case minimum: 20 
for the TCPC measure, 35 for MSPB, 10 for procedural episodes, and 20 
for acute medical inpatient medical condition episodes. The VM measures 
are computed for the TIN; thus, each VM measure score was assigned to 
each MIPS eligible clinician in the TIN regardless of whether they 
submit as an individual or as a group. The episode-based measures are 
computed for both the TIN/NPI and the TIN; these measure scores were 
assigned to clinicians based on the clinician's submission status, 
which in this modeling was based on the quality domain. For clinicians 
participating as individuals, the TIN/NPI level score was used if 
available and if the minimum case size was met. For clinicians 
participating as groups, the TIN level score was used, if available, 
and if the minimum case size was met. For clinicians with no measures 
meeting the minimum case requirement, we did not estimate a score for 
the cost performance category, and the weight for the cost performance 
category was reassigned to the quality performance category. The raw 
cost measure scores were mapped to scores on the scale of 1-10, using 
benchmarks developed based on all measures that met the case minimum 
during the relevant performance period. For the episode-based cost 
measures, separate benchmarks were developed for TIN/NPI level scores 
and TIN level scores. For each clinician, a cost performance category 
score was computed as the average of the measure scores available for 
the clinician, as described previously.
(c) Methodology To Estimate the Facility-Based Measurement Scoring
    As discussed in section III.H.3.i.(1)(d) of this proposed rule, we 
are implementing facility-based measurement for the 2019 MIPS 
performance period. In facility-based measurement, we determine the 
eligible clinician's MIPS score based on Hospital VBP performance score 
for eligible clinicians or groups who primarily furnish services within 
a hospital. Given that we are not requiring eligible clinicians to opt-
in to facility-based measurement, it is possible that a MIPS an 
eligible clinician or a group is eligible for facility-based 
measurement and participates in MIPS as an individual or a group. In 
these cases, we use the higher combined quality and cost performance 
category scores.
    Data was not available to attribute specific hospital VBP 
performance score to MIPS eligible clinicians, hence we made the 
following assumptions. For MIPS eligible clinicians and groups who are 
eligible for facility-based measurement and who previously submitted 
quality data to PQRS (which we used to estimate the quality performance 
category score), we did not estimate a facility-based score. We instead 
calculated a MIPS quality and cost score based on the available quality 
measures and cost data. Some clinicians who previously submitted PQRS 
quality data may receive a higher score through facility-based 
measurement, but we are unable to identify those clinicians due to data 
limitations and therefore believe the score based on their submitted 
data is more likely to reflect their performance.
    For MIPS eligible clinicians that did not previously submit data to 
PQRS and were eligible for facility-based measurement, we estimated a 
facility-based score by taking the median MIPS quality and cost 
performance score. We believe it is important to develop an estimate 
for this cohort because we would have otherwise assigned this group a 
quality performance category percent score of zero percent which we 
believe would have underestimated their MIPS final score. Given the 
data limitations in assigning a specific hospital score to a clinician, 
we selected the median MIPS quality and cost performance scores as that 
represents the quality cost performance category scores that a 
clinician working in a hospital with median performance would receive.
(d) Methodology To Estimate the Promoting Interoperability Performance 
Category Score
    As discussed in section III.H.3.h.(5)(d)(ii) of this proposed rule, 
we are proposing to modify the measures and scoring for the Promoting 
Interoperability performance category score. We proposed to simplify 
scoring by eliminating the concept of base and performance scores and 
focusing on a smaller set of measures which are scored on performance. 
We estimated Promoting Interoperability performance category scores 
using data from the CY 2016 Medicare and Medicaid EHR Incentive 
Programs. Because the EHR Incentive Programs data are based on 
attestation at the NPI level, the Promoting Interoperability 
performance category scores are based on the individual level 
regardless of whether the clinician was part of a group submission or 
part of an APM entity. We did not calculate a group or APM score for 
the Promoting Interoperability performance category.
    Although we had attestation information for the Medicare EHR 
Incentive Program, we did not have detailed attestation information for 
the Medicaid EHR Incentive Program. Therefore, we used incentive 
payments (excluding incentive payments for the adoption, 
implementation, and upgrade of CEHRT) as a proxy for attestation for 
Medicaid EHR Incentive Program participants. To proxy performance, we 
used the 2016 Medicare EHR Incentive Program data and estimated the 
median score among Medicare eligible clinicians submitting data for 
four Promoting Interoperability measures that had data available in the 
2016 Medicare EHR Incentive Program. For the e-Prescribing objective, 
we used the e-Prescribing measure and did not assume any bonus points 
for the Query of Prescription Drug Monitoring Program (PDMP) or the 
Verify Opioid Treatment Agreement measures. For the Health Information 
Exchange objective, we used the Health Information Exchange measure to 
proxy performance for the two proposed measures in the objective: 
Support Electronic Referral Loops by Sending Health Information and 
Support Electronic Referral Loops by Receiving and Incorporating Health 
Information. For the Provider to Patient Exchange objective, we used 
the Provide Patient Access to View, Download, or Transmit measure to 
estimate performance for the proposed Provide Patients Electronic 
Access to Their Health Information measure. For the Public Health and 
Clinical Data Exchange objective, we assumed that clinicians would meet 
the proposed reporting requirements and would receive 10 points for the 
objective. We combined the median scores for each measure, which led to 
an estimated MIPS Promoting Interoperability performance category 
median score of 73 points. This estimated MIPS Promoting 
Interoperability performance category score was applied to all eligible 
clinicians that attested to participating in the EHR Incentive Programs 
in our scoring model. The selection of a 73 point Promoting 
Interoperability

[[Page 36064]]

performance category score is lower than the maximum score of 100 
percentage points. Our rationale for selecting a 73 point performance 
category score is that the proposed revision of the Promoting 
Interoperability criteria would lead to lower scores due to fewer 
clinicians being able to report measures and achieve maximum 
performance for the Health Information Exchange Promoting 
Interoperability Objective. We do not expect all MIPS eligible 
clinicians participating in MIPS to receive a score of 73 for the 
Promoting Interoperability performance category; however, we believe 
this is a reasonable approach given the unavailability of MIPS CY 2017 
performance period data in time for this proposed rule. We anticipate 
using actual MIPS performance period data in the final rule if 
available in time. We expect that a large proportion of eligible 
clinicians who submit EHR Incentive Program data will likely achieve a 
Promoting Interoperability performance category score of 73 points.
    For those eligible clinicians who did not attest in either the 2016 
Medicare or Medicaid EHR Incentive Program, we evaluated whether the 
MIPS eligible clinician could have their Promoting Interoperability 
performance category score reweighted. As finalized in the CY 2017 (81 
FR 77069 through 77070) and CY 2018 (82 FR 53625 through 52626) Quality 
Payment Program final rules, the Promoting Interoperability performance 
category weight is set equal to 0 percent, and the weight is 
redistributed to the quality or improvement activities performance 
category for non-patient facing MIPS eligible clinicians, hospital-
based MIPS eligible clinicians, ASC-based MIPS eligible clinicians, or 
those who request and are approved for a significant hardship or other 
type of exception, including a significant hardship exception for small 
practices, or clinicians who are granted an exception based on 
decertified EHR technology (82 FR 53780 through 53786). We are also 
proposing in section III.H.3.h.(5)(h) of this proposed rule to continue 
automatic reweighting for NPs, PAs, CNSs and CRNAs and to add an 
automatic reweighting policy for physical therapists, occupational 
therapist, clinical social workers, and clinical psychologists, which 
we have incorporated into our model. We used the non-patient facing and 
hospital-based indicators and specialty and small practice indicators 
as calculated in the initial MIPS eligibility run for the 2017 MIPS 
performance period (81 FR 77069 through 77070). For significant 
hardship exceptions, we used the 2016 final approved significant 
hardship file from the Medicare EHR Incentive Program. If a MIPS 
eligible clinician did not attest and did not qualify for a reweighting 
of their Promoting Interoperability performance category, the Promoting 
Interoperability performance category score was set to 0 percent.
(e) Methodology To Estimate the Improvement Activities Performance 
Category Score
    We modeled the improvement activities performance category score 
based on 2016 APM participation and historic participation in 2016 PQRS 
and 2016 Medicare and Medicaid EHR Incentive Programs. We are not 
proposing any policy changes that impact scoring for the improvement 
activities performance category. Our model identified 2016 participants 
in the Shared Savings Program, Next Generation ACO Model and the 
Pioneer ACO Model, and assigned them an improvement activity score of 
100 percent, consistent with our policy to assign an improvement 
activities score of 100 percent to ACO participants who were not 
excluded due to being QPs. Due to limitations in 2016 data, our model 
was not able to include 2016 participants in APMs other than the Shared 
Savings Program, the Pioneer ACO Model, and the Next Generation ACO 
Model.
    Clinicians and groups not participating in a MIPS APM were assigned 
an improvement activities performance category score based on their 
performance in the quality and Promoting Interoperability performance 
categories. MIPS eligible clinicians whose 2016 PQRS data meets all the 
MIPS quality submission criteria (for example, submitting 6 measures 
with data completeness, including one outcome or high priority 
measures) and had an estimated Promoting Interoperability performance 
category score of 73 percent (if Promoting Interoperability is 
applicable to them) were assigned an improvement activities performance 
category score of 100 percent. MIPS eligible clinicians who did not 
participate in 2016 PQRS or the 2016 Medicare or Medicaid EHR Incentive 
Program (if it was applicable), received an improvement activity 
performance category score of 0 percent, with the rationale that these 
clinicians may be less likely to participate in MIPS if they have not 
previously participated in other programs.
    For the remaining MIPS eligible clinicians not assigned an 
improvement activities performance category score of 0 or 100 percent 
in our model, we assigned a score that corresponds to submitting one 
medium-weighted improvement activity. The MIPS eligible clinicians 
assigned an improvement activity performance category score 
corresponding to a medium-weighted activity include (a) those who 
submitted some quality measures under the 2016 PQRS but did not meet 
the MIPS quality submission criteria or (b) those who did not submit 
any quality data under the 2016 PQRS who attested under the Medicare 
EHR Incentive program or received an incentive payment (excluding adopt 
implement and upgrade payments) from the Medicaid EHR Incentive 
Program. We assumed that these clinicians may be likely to partially, 
but not fully, participate in the improvement activities category. For 
non-patient facing clinicians, clinicians in a small practice 
(consisting of 15 or fewer professionals), clinicians in practices 
located in a rural area, clinicians in a geographic healthcare 
professional shortage area (HPSA) practice or any combination thereof, 
the medium weighted improvement activity was assigned one-half of the 
total possible improvement activities performance category score (20 
out of a 40 possible points or 50 percent). The remaining MIPS eligible 
clinicians who were not assigned an improvement activities performance 
category score of 0, 50, or 100 percentage points were assigned a score 
corresponding to one medium-weighted activity (10 out of 40 possible 
points or 25 percent). The policy finalized in the CY 2018 Quality 
Payment Program final rule at Sec.  414.1380(b)(3), and discussed in 
section III.H.3.i.(1)(e)(i)(D) of this proposed rule, states that a 
MIPS eligible clinician or group in a practice that is certified as a 
patient-centered medical home or comparable specialty practice, as 
determined by the Secretary, receives full credit for performance on 
the improvement activities performance category. In other words, MIPS 
eligible clinicians in a patient centered medical home or comparable 
specialty societies would qualify for an improvement activities 
performance category score of 100 percent. However, due to lack of 
available data, we were not able to identify MIPS eligible clinicians 
in patient-centered medical homes or comparable specialty societies in 
our scoring model.
(f) Methodology To Estimate the Complex Patient Bonus
    In sections III.H.3.i.(2)(a)(ii) of this proposed rule, we are 
proposing to continue the complex patient bonus. Consistent with the 
policy to define complex patients as those with high

[[Page 36065]]

medical risk or with dual eligibility, our scoring model calculated the 
bonus by using the average Hierarchical Condition Category (HCC) risk 
score, as well as the MIPS eligible clinician's patients dual eligible 
proportion calculated for each NPI in the 2016 Physician and Other 
Supplier Public Use File. The dual eligible proportion for each MIPS 
eligible clinician was multiplied by 5. We also generated a group 
average HCC risk score by weighing the scores for individual clinicians 
in each group by the number of beneficiaries they have seen. We 
generated group dual eligible proportions using the weighted average 
dual eligible patient ratio for all MIPS eligible clinicians in the 
groups, which was then multiplied by 5. The complex patient bonus was 
calculated by adding together the average HCC risk score and the 
percent of dual eligible patients multiplied by 5, with a 5-point cap.
(g) Methodology To Estimate the Final Score
    As proposed in sections III.H.3.h.(2)(a)(ii), III.H.3.h.(3)(a), 
III.H.3.h.(4)(a), III.H.3.h.(5)(d)(i) and summarized in section 
III.H.3.i.(2)(b) of this proposed rule, our model assigns a final score 
for each TIN/NPI by multiplying each performance category score by the 
corresponding performance category weight, adding the products 
together, multiplying the sum by 100 points, and adding the complex 
patient bonus. After adding any applicable bonus for complex patients, 
we reset any final scores that exceeded 100 points equal to 100 points. 
For MIPS eligible clinicians who were assigned a weight of zero percent 
for the Promoting Interoperability due to a significant hardship or 
other type of exception, the weight for the Promoting Interoperability 
performance category was redistributed to the quality performance 
category. For MIPS eligible clinicians who did not have a cost 
performance category score, the weight for the cost performance 
category was redistributed to the quality performance category. In our 
scoring model, we did not address scenarios where a zero percent weight 
would be assigned to the quality performance category or the 
improvement activities performance category.
(h) Methodology To Estimate the MIPS Payment Adjustment
    As described in section III.H.3.j.(1) of this proposed rule, we 
applied a hierarchy to determine which final score should be used for 
the payment adjustment for each MIPS eligible clinician when more than 
one final score is available (for example if a clinician qualifies for 
a score for an APM entity and a group score, we select the APM entity 
score).
    We then calculated the parameters of an exchange function in 
accordance with the statutory requirements related to the linear 
sliding scale, budget neutrality, minimum and maximum adjustment 
percentages and aggregate exceptional performance payment adjustment 
amounts (as finalized under Sec.  414.1405), using a performance 
threshold of 30 points and an exceptional performance threshold of 80 
points (as proposed in sections III.H.3.j.(2) and III.H.3.j.(3) of this 
proposed rule). We used these resulting parameters to estimate the 
positive or negative MIPS payment adjustment based on the estimated 
final score and the Medicare Physician Fee Schedule paid amount. We 
considered other performance thresholds which are discussed in section 
VII.G. of this proposed rule.
    In the CY 2017 (81 FR 77522) and CY 2018 (82 FR 53932) Quality 
Payment Program final rules, we applied a 90 percent participation 
assumption for clinicians in all practice sizes and an alternative of 
80 percent participation because participation in legacy programs 
(PQRS, the VM, and Medicare/Medicaid EHR Incentive programs) may 
underestimate our expected participation in MIPS. Given the proposed 
changes in eligibility and the proposed opt-in policy in section 
VII.F.8.b. of this proposed rule, we believe that the percentage of 
eligible clinicians participating in MIPS will increase, so we did not 
apply a participation assumption.
(3) Impact of Payments by Practice Size
    Using the assumptions provided above, our model estimates that $372 
million would be redistributed through budget neutrality and that the 
maximum positive payment adjustments are 5.6 percent after considering 
the MIPS payment adjustment and the additional MIPS payment adjustment 
for exceptional performance.
    Table 98 shows the impact of the payments by practice size and 
whether the clinicians submitted data to either PQRS or the Medicare or 
Medicaid EHR Incentive program. We continue to monitor the effects of 
participation, particularly for clinicians in small practices; 
therefore we present the summary results stratified by whether a 
clinician is expected to submit data to MIPS because they had submitted 
data to either PQRS or the Medicare or Medicaid EHR Incentive Programs, 
or if the clinician is facility-based. Clinicians in small practices 
(1-15 clinicians) that we estimate would participate in MIPS perform as 
well as or better than mid-size practices. Overall, clinicians in small 
practices participating in MIPS would receive a 1.9 percent increase in 
their paid amount, which is similar to the payment amount received by 
the total MIPS eligible clinician population. After considering the 
positive adjustments and subtracting the negative adjustments, eligible 
clinicians in small practices would have an increase in funds which is 
consistent with all MIPS eligible clinicians. Table 98 also shows that 
96.1 percent of MIPS eligible clinicians that participate in MIPS are 
expected to receive positive or neutral payment adjustments. Among 
those who we estimate would not submit data to MIPS, 88 percent are in 
small practices (28,096 out of 31,921 clinicians). To address 
participation concerns, we have policies targeted towards small 
practices including technical assistance and special scoring policies 
to minimize burden and facilitate small practice participation in MIPS 
or APMs. Again, we plan to update these numbers in the final rule when 
we have actual MIPS participation for the 2017 MIPS performance period.

[[Page 36066]]



              Table 98--MIPS Estimated Payment Year 2021 Impact on Total Estimated Paid Amount by Participation Status and Practice Size *
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                        Combined impact
                                                                                                  Percent eligible                      of negative and
                                                                               Percent eligible  clinicians with a                          positive
                                                             Number of MIPS    clinicians with        positive       Percent eligible   adjustments and
                     Practice size *                            eligible         positive or      adjustment with    clinicians with      exceptional
                                                               clinicians      neutral payment      exceptional      negative payment     performance
                                                                                  adjustment          payment           adjustment         payment as
                                                                                                     adjustment                         percent of paid
                                                                                                                                           amount **
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             Among those submitting data ***
--------------------------------------------------------------------------------------------------------------------------------------------------------
(1) 1-15.................................................            110,284               92.5               46.4                7.5                1.9
(2) 16-24................................................             27,798               89.1               35.5               10.9                1.3
(3) 25-99................................................            128,988               93.2               44.2                6.8                1.5
(4) 100+.................................................            351,174               98.8               65.3                1.2                2.5
                                                          ----------------------------------------------------------------------------------------------
    Overall..............................................            618,244               96.1               56.2                3.9                2.0
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             Among those not submitting data
--------------------------------------------------------------------------------------------------------------------------------------------------------
(1) 1-15.................................................             28,096                0.0                0.0              100.0               -6.1
(2) 16-24................................................              1,282                0.0                0.0              100.0               -6.0
(3) 25-99................................................              1,871                0.0                0.0              100.0               -5.9
(4) 100+.................................................                672                0.0                0.0              100.0               -6.1
                                                          ----------------------------------------------------------------------------------------------
    Overall..............................................             31,921                0.0                0.0              100.0               -6.1
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Practice size is the total number of TIN/NPIs in a TIN.
** 2014, 2015 and 2016 data used to estimate 2019 payment adjustments. Payments estimated using 2015 and 2016 dollars.
*** Includes facility-based clinicians whose quality data is submitted through hospital programs.

d. Potential Costs of Compliance With the Promoting Interoperability 
and Improvement Activities Performance Categories for Eligible 
Clinicians
(1) Potential Costs of Compliance With Promoting Interoperability 
Performance Category
    In section III.H.3.h.(5)(c) of this proposed rule, we discuss the 
requirement to use EHR technology certified to the 2015 Edition 
beginning with the 2019 MIPS performance period for the Promoting 
Interoperability performance category. As discussed in section V.B.3 of 
this proposed rule, we assume a slight decrease in overall information 
collection burden costs for the Promoting Interoperability performance 
category related to having fewer measures to submit.
    With respect to any costs unrelated to data submission, although 
this proposal would require some investment in systems updates, our 
policy prior to this regulation as reflected in Sec.  414.1305, is that 
2015 Edition CEHRT will be required beginning with the 2019 MIPS 
performance period/2021 MIPS payment year (82 FR 53671). Therefore, we 
do not anticipate any additional costs due to this regulation.
(2) Potential Costs of Compliance With Improvement Activities 
Performance Category
    Under the policies established in the CY 2017 Quality Payment 
Program final rule, the costs for complying with the improvement 
activities performance category requirements could have potentially led 
to higher expenses for MIPS eligible clinicians. Costs per full-time 
equivalent primary care clinician for improvement activities will vary 
across practices, including for some activities or certified patient-
centered medical home practices, in incremental costs per encounter, 
and in estimated costs per (patient) member per month.
    Costs for compliance with previously finalized policies may vary 
based on panel size (number of patients assigned to each care team) and 
location of practice among other variables. For example, Magill (2015) 
conducted a study of certified patient-centered medical home practices 
in two states.\64\ That study found that costs associated with a full-
time equivalent primary care clinician, who was associated with 
certified patient-centered medical home practices, varied across 
practices. Specifically, the study found an average cost of $7,691 per 
month in Utah practices, and an average of $9,658 in Colorado 
practices. Consequently, incremental costs per encounter were $32.71 
for certified patient-centered medical home practices in Utah and 
$36.68 in Colorado (Magill, 2015). The study also found that the 
average estimated cost per patient member, per month, for an assumed 
panel of 2,000 patients was $3.85 in Utah and $4.83 in Colorado. 
However, given the lack of comprehensive historical data for 
improvement activities, we are unable to quantify those costs in detail 
at this time. The findings presented in these papers have not changed. 
Due to the unavailability of MIPS CY 2017 performance period data in 
time for this proposed rule, we do not know which improvement 
activities clinicians have elected. As a result, it is difficult to 
quantify the costs, cost savings, and benefits associated 
implementation of improvement activities. We will report the costs and 
benefits of implementing the improvement activities for the final rule 
if the performance data are received in time.
---------------------------------------------------------------------------

    \64\ Magill et al. ``The Cost of Sustaining a Patient-Centered 
Medical Home: Experience from 2 States.'' Annals of Family Medicine, 
2015; 13:429-435.
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    We have considered factors that also contribute to the difficulty 
of identifying compliance costs for the improvement activities 
performance category in the CY 2018 Quality Payment Program final rule 
(82 FR 53845).

[[Page 36067]]

    Although we are unable to quantify the compliance costs of the 
improvement activities performance category, we do believe that because 
we are proposing an opt-in policy (as described in section II.C.2.c of 
this proposed rule), we would add approximately 87,000 additional 
clinicians to the MIPS eligible clinicians. In the section V.B.4 of 
this proposed rule, we have assumed that those who have elected to opt-
in have already been voluntary reporters in MIPS and would not have 
additional compliance costs as a result of this regulation. Thus, we 
believe the overall potential cost of compliance would not increase 
because of this proposed rule.
    Further, we anticipate that the vast majority of clinicians 
submitting improvement activities data to comply with existing MIPS 
policies could continue to submit the same activities under the 
policies established in this proposed rule. Previously finalized 
improvement activities continue to apply for the current and future 
years unless otherwise modified per rule-making (82 FR 54175); we are 
only proposing modifications to a few activities and proposing to 
remove one improvement activity in this proposed rule. We refer readers 
to Table H in the Appendix of the CY 2017 Quality Payment Program final 
rule (81 FR 77177 through 77199) and Tables F and G in the Appendix of 
the CY 2018 Quality Payment Program final rule (82 FR 54175 through 
54229) for our previously finalized 112 improvement activities 
established in the Improvement Activities Inventory. In section 
III.H.3.h.(4)(d)(ii) of this proposed rule, we are proposing 6 new 
improvement activities, 5 modifications and 1 removal of an existing 
activity.
    Similarly, we believe that third parties who submit data on behalf 
of clinicians who prepared to submit data in the transition year will 
not incur additional costs as a result of this proposed rule. We 
request comments that provide additional information that would enable 
us to quantify the costs, costs savings, and benefits associated with 
implementation of improvement activities in the inventory.
    In section III.H.3.h.(4)(e) of this proposed rule, we discuss how 
eligible clinicians can participate in the CMS study on burdens 
associated with reporting quality measures for each MIPS performance 
period. Eligible clinicians who are interested in participating can 
sign up and an adequate sample size is then selected by CMS from these 
potential participants. In the CY 2018 Quality Payment Program final 
rule, the sample size for the CY 2018 performance period was set at a 
minimum of 102 MIPS eligible clinicians (81 FR 77196). Each study 
participant is required to complete a survey prior to submitting MIPS 
data and another survey after submitting MIPS data. In section 
III.H.3.h.(4)(e) of this proposed rule, for the CY 2019 performance 
period, we are proposing an increase to the sample size to a minimum of 
200 MIPS eligible clinicians. However, we are proposing to make the 
focus group a requirement only for a selected subset of the study 
participants beginning with the CY 2019 performance period and future 
years. Thus, out of the minimum of 200 study participants as proposed 
above, we would select a minimum number of 100 clinicians to 
participate in focus groups, this selection will be done primarily by 
purposive sampling, and may apply random sampling only in a situation 
when we have to pick between same/similar participants. Completing each 
survey is estimated to require approximately 15 minutes; therefore, the 
annual hourly burden per participant is approximately 30 minutes. The 
annual hourly burden associated with the increase in sample size from 
102 to 200 is estimated to be 49 hours (98 clinician's x 0.5 hours). 
The total estimated annual cost burden is estimated to be $10,116 
($206.44/hour x 49 hours). While the sample size of the study is 
increasing, we are not proposing a change to the sample size of MIPS 
eligible clinicians participating in the focus group, so no burden is 
estimated for participating in that activity.
e. Assumptions & Limitations
    We would like to note several limitations to our estimates of MIPS 
eligible clinicians' eligibility and participation, negative MIPS 
payment adjustments, and positive payment adjustments for the 2021 MIPS 
payment year. We based our analyses on the data prepared to support the 
2017 performance period initial determination of clinician and special 
status eligibility (available via the NPI lookup on qpp.cms.gov),\65\ 
participant lists using the APM Participation List for the third 
snapshot date of the 2017 QP performance period and historical PQRS 
data, the Medicare/Medicaid EHR Incentive Programs data, including 
CAHPS for PQRS, and the VM. No scoring model, including the one 
presented in this proposed rule, can fully reflect MIPS eligible 
clinicians' behavioral responses to MIPS because there is no substitute 
for actual data. The scoring model assumes that quality measures or the 
Medicare/Medicaid EHR Incentive Programs data submitted and the 
distribution of scores on those measures would be similar under the 
Quality Payment Program in the 2021 MIPS payment year as they were 
under the 2016 PQRS program. We will update results with the analysis 
of actual MIPS performance data if it is available in time for the 
publication of the final rule. The scoring model does not reflect the 
growth in Advanced APM participation between 2018 and 2019 (Quality 
Payment Program Years 2 and 3) because that data is not available at 
the detailed level needed for our scoring analysis.
---------------------------------------------------------------------------

    \65\ The time period for this eligibility file (September 1, 
2015 to August 31, 2016) maximizes the overlap with the performance 
data in our model.
---------------------------------------------------------------------------

    In our MIPS eligible clinician assumptions, we assumed that 33 
percent of the opt-in eligible clinicians that participated in PQRS 
would elect to opt-in to the MIPS program. It is difficult to predict 
whether clinicians will elect to opt-in to participate in MIPS with the 
proposed policy.
    There are additional limitations to our estimates: (1) We only 
estimated the potential impact of facility-based scoring for MIPS 
eligible clinicians that are eligible for facility-based measurement 
and would have a quality performance category score of zero from 
failure to submit quality data; (2) because we used historic data, we 
assumed participation in the Promoting Interoperability and Improvement 
Activities performance categories would be similar to prior years in 
other relevant programs; (3) we assumed performance for those two 
categories based on population norm and not individual performance; (4) 
we anticipate the scores for these performance categories may differ 
once we receive actual MIPS performance data, and (5) to the extent 
that there are year-to-year changes in the data submission, volume and 
mix of services provided by MIPS eligible clinicians, the actual impact 
on total Medicare revenues will be different from those shown in Table 
98. Due to the limitations described, there is considerable uncertainty 
around our estimates that is difficult to quantify in detail.

G. Alternatives Considered

    This proposed rule contains a range of policies, including some 
provisions related to specific statutory provisions. The preceding 
preamble provides descriptions of the statutory provisions that are 
addressed, identifies those policies when discretion has been

[[Page 36068]]

exercised, presents rationale for our proposed policies and, where 
relevant, alternatives that were considered. For purposes of the 
payment impact on PFS services of the policies contained in this 
proposed rule, we presented the estimated impact on total allowed 
charges by specialty. The alternatives we considered, as discussed in 
the preceding preamble sections, would result in different payment 
rates, and therefore, result in different estimates than those shown in 
Table 94 (CY 2019 PFS Estimated Impact on Total Allowed Charges by 
Specialty).
    For purposes of the payment impact on the Quality Payment Program, 
we view the performance threshold and the additional performance 
threshold to be the critical factors affecting the distribution of 
payment adjustments under the Quality Payment Program, and the 
alternatives that we considered focus on those policies. We ran 
estimates with performance thresholds of 25 and 35 as an alternative to 
30, so that we could estimate a more moderate increase of the 
performance threshold and a more aggressive increase. We also ran the 
models with an additional performance threshold of 70 instead of the 
proposed 80 points. This alternative would maintain the additional 
performance threshold that was in years 2 and 3. In the model with a 
performance threshold of 30 and an additional performance threshold of 
70, we estimate that $372 million will be redistributed through budget 
neutrality, and there will be a maximum payment adjustment of 4.3 
percent and 8.7 percent of MIPS eligible clinicians will receive a 
negative payment adjustment after considering the MIPS payment 
adjustment and the additional MIPS payment adjustment for exceptional 
performance. In the model with a performance threshold of 25 and an 
additional performance threshold of 80, we estimate that $340 million 
will be redistributed through budget neutrality, and there will be a 
maximum payment adjustment of 5.4 percent and 6.9 percent of MIPS 
eligible clinicians will receive a negative payment adjustment after 
considering the MIPS payment adjustment and the additional MIPS payment 
adjustment for exceptional performance. In the model with a performance 
threshold of 35 and an additional performance threshold of 80, we 
estimate that $408 million will be redistributed through budget 
neutrality, and there will be a maximum payment adjustment of 5.8 
percent and 10.9 percent of MIPS eligible clinicians will receive a 
negative payment adjustment after considering the MIPS payment 
adjustment and the additional MIPS payment adjustment for exceptional 
performance.
    We ran estimates on the potential change in population if we set 
the third low volume threshold set at 100 as an alternative to 200 
covered services. We estimate that 50,260 clinicians would elect to 
opt-in for a total population of 658,400. We also estimated the effect 
of applying the opt-in policy without adding the third low-volume 
threshold criterion. We estimate that 19,621 clinicians would elect to 
opt-in for a total population of 627,761.

H. Impact on Beneficiaries

    There are a number of changes in this proposed rule that would have 
an effect on beneficiaries. In general, we believe that many of these 
changes, including those intended to improve accuracy in payment 
through regular updates to the inputs used to calculate payments under 
the PFS, would have a positive impact and improve the quality and value 
of care provided to Medicare providers and beneficiaries.
1. Evaluation and Management Documentation
    For example, we estimate that the evaluation and management (E/M) 
visit documentation changes proposed in section II.I of this proposed 
rule may significantly reduce the amount of time practitioners spend 
documenting these services. While little research is available on 
exactly how much time physicians and non-physician practitioners spend 
specifically documenting E/M visits, according to one recent estimate, 
primary care physicians spend on average, 84 minutes or 1.4 hours per 
day (24 percent of the time that they spend working within an EHR) 
documenting progress notes.\66\ Another study found that primary care 
physicians spend an average of 2.1 hours per day writing progress notes 
(both in-clinic and remote access).\67\ Assuming an average of 20 
patient visits per day, one E/M visit per patient, and using the higher 
figure of 2.1 hours per day spent documenting these visits, we estimate 
that documentation of an average outpatient/office E/M visit takes 6.3 
minutes.\68\
---------------------------------------------------------------------------

    \66\ Arndt BG, Beasley JW, Watkinson MD, et al. Tethered to the 
EHR: Primary care physician workload assessment using EHR event log 
data and time-motion observations. Ann Fam Med. 2017;15:427-33.
    \67\ Tai-Seale M, Olson CW, Li J, et al. Electronic health 
record logs indicate that physicians split time evenly between 
seeing patients and desktop medicine. Health Aff (Milwood). 
2017;36:655-62.
    \68\ 20 patient visits per day based on the average number 
reported in the Physicians Foundation 2016 Survey of America's 
Physicians, available online at https://physiciansfoundation.org/wp-content/uploads/2018/01/Biennial_Physician_Survey_2016.pdf.
---------------------------------------------------------------------------

    We believe that our proposals to reduce redundancy in visit 
documentation, to allow auxiliary staff and the beneficiary to enter 
certain information in the medical record that would be verified but 
not required to be re-documented by the billing practitioner, to allow 
the choice of visit level and documentation based on MDM or time as 
alternatives to the current framework, and to require only minimum 
documentation (the amount required for a level 2 visit) for all visits 
except level 1 visits may reduce the documentation time by one quarter 
of the current time for the average office/outpatient visit. Under this 
assumption, these proposals would save clinicians approximately 1.6 
minutes of time per office/outpatient E/M visit billed to Medicare. For 
a full-time practitioner whose panel of patients is 40 percent Medicare 
(60 percent other payers), this would translate to approximately 51 
hours saved per year.\69\
---------------------------------------------------------------------------

    \69\ Forty percent of 20 total patients per day = 8 Medicare 
vists per day. (Eight visits per day) * (1.6 minutes per visit) * 
(240 days per year) = 51.2 hours.
---------------------------------------------------------------------------

    We note that stakeholders have emphasized to us in public comments 
that whatever reductions may be made to the E/M documentation 
guidelines for purposes of Medicare payment, physicians and non-
physician practitioners will still need to document substantial 
information in their progress notes for clinical, legal, operational, 
quality reporting and other purposes, as well as potentially for other 
payers. Furthermore, there may be a ramp-up period for physicians and 
non-physician practitioners to implement the proposed documentation 
changes in their clinical workflow and EHR such that the effects of 
mitigating documentation burden may not be immediately realized. 
Accordingly, we believe the total amount of time practitioners spend on 
E/M visit documentation may remain high, despite the time savings that 
we estimate in this section could result from our E/M documentation 
proposals. These and all other improvements to payment accuracy that we 
are proposing for CY 2019 are described in greater detail in section 
II.I of this proposed rule. We welcome public comments on our 
assumptions for the estimated reduction in documentation burden related 
to these proposals.

[[Page 36069]]

2. Modernizing Medicare Physician Payment by Recognizing Communication 
Technology-Based Services
    As noted in section II.D. of this proposed rule, for CY 2019, we 
are aiming to increase access for Medicare beneficiaries to physicians' 
services that are routinely furnished via communication technology by 
clearly recognizing a discrete set of services that are defined by and 
inherently involve the use of communication technology. Accordingly, we 
have several proposals for modernizing Medicare physician payment for 
communication technology-based services.
    The use of communication technology-based services will provide new 
options for physicians to treat patients. These services could help to 
avoid unnecessary office visits, could consist of services that are 
already occurring but are not being separately paid, or could 
constitute new services. Medicare would pay $14 per visit in the first 
year for these communication technology-based services, compared with 
$92 per visit for the corresponding established patient visits.
    Practitioners have a choice of when to use the communication 
technology-based services. Because of the low payment rate relative to 
that for an office visit, we are assuming that usage of these services 
will be relatively low. In addition, we expect that the number of new 
or newly billable visits and subsequent treatments will outweigh the 
number of times that communication technology-based services will be 
used instead of more costly services. As a result, we expect that the 
financial impact of paying for the communication technology-based 
services will be an increase in Medicare costs. We estimate that usage 
of these services will result in fewer than 1 million visits in the 
first year but will eventually result in more than 19 million visits 
per year, ultimately increasing payments under the PFS by about 0.2 
percent. In order to maintain budget neutrality in setting proposed 
rates for CY 2019, we assumed the number of services that would result 
in a 0.2 percent reduction in the proposed conversion factor.
    As with all estimates, and particularly those for new benefits, 
this outcome is highly uncertain. Because communication technology-
based services is a new area for healthcare coverage, the available 
information on which to base estimates is limited and is usually not 
directly applicable, particularly to a new Medicare benefit. The cost 
and utilization estimates are based on Medicare claims data together 
with a study published in Health Affairs,\70\ which examined the cost 
and utilization of telehealth in the private sector. While this study 
was the most applicable for an estimate, we note that the results from 
this program may be different because Medicare experience may differ 
from private sector behavior and because the study was limited to acute 
respiratory infection visits. We also note that the study cites the use 
of direct-to-consumer telehealth companies, many of which provide 
access to care 24 hours per day, 7 days per week, 365 days per year, 
whereas the service described by HCPCS code GVCI1 is limited to only 
established patients.
---------------------------------------------------------------------------

    \70\ Ashwood, J.S. (2017 March) Direct-To-Consumer Telehealth 
May Increase Access To Care But Does Not Decrease Spending. Health 
Affairs.
---------------------------------------------------------------------------

    We are also proposing to make separate payment for these services 
when furnished by RHCs and FQHCs. A potential estimate of utilization 
and overall cost of these services by RHCs and FQHCs could be derived 
by comparing their use of chronic care management and other care 
management services to the same services furnished by practitioners 
paid under the PFS, since these care management services are also 
separately billable and do not take place in-person. Based on this 
comparison, and without considering potential variables and issues 
specific to these services, the impact of this proposal would be less 
than $1 million in additional Medicare spending in the first year and 
could eventually result in up to $20 million in spending per year in 
future years. These estimates are uncertain and could change after 
further consideration of the potential variables and issues specific to 
these services.
3. Outpatient Therapy Services
    As noted in section II.M. of this proposed rule, we are also 
proposing to end functional reporting for outpatient therapy services 
as part of our burden reduction efforts in response to the RFI on CMS 
Flexibilities and Efficiencies that was issued in the CY 2018 PFS 
proposed rule (82 FR 34172 through 34173). Our functional reporting 
system currently requires therapy practitioners and providers to 
report, whenever functional reporting is required, non-payable HCPCS G-
codes and modifiers--typically in pairs--to convey information about 
the beneficiary's functional limitation category and functional status 
throughout the PT, OT, or SLP episode of care. In addition, each time 
functional reporting is required on the claim, the therapy provider 
must also document the functional reporting G-codes and their modifiers 
in the medical record. In this proposed rule, we are proposing to 
eliminate this requirement that therapy practitioners and providers 
report HCPCS G-codes and modifiers or document in the medical record to 
convey functional reporting status for PT, OT or SLP episode of care.
    In order to quantify the amount of burden reduction, we decided to 
estimate the total amount of time that therapy practitioners spend 
doing functional reporting. To do this, we first looked at our data for 
CY 2017 for professional claims by the type of plan of care reported 
primarily by therapists in private practice (TPPs), including physical 
therapists, occupational therapists, and speech-language pathologists. 
We found that the overall utilization of the 42 functional reporting 
HCPCS G-codes totaled 15,456,421 single units, or 7,728,211 pairs.
    We then considered the time, on average, it might take to report on 
the claim and document in the medical record each pair of HCPCS G-
codes. We note this includes the time it takes to make the initial 
determination of the HCPCS G-code functional limitation category, as 
well as the time needed to make each initial and/or subsequent 
assignments for the applicable severity modifiers in order to define 
the patient's functional status. We then made the assumption that it 
would take between 1 minute and 1.5 minutes, on average, to report the 
HCPCS G-code and modifier pair each time functional reporting is 
required. Using the total utilization of G-code pairs and the range of 
1 minute to 1.5 minutes, we calculated that TPPs would have saved 
between 128,804 and 193,206 hours (or 7,728,211 to 11,592,317 minutes) 
collectively in CY 2017 if the functional reporting requirements had 
not been in place. We believe this is a reasonable projection for the 
potential savings to TPPs, physicians and certain nonphysician 
practitioners in future years if we finalize our proposal to end 
functional reporting effective January 1, 2019.
    Because therapy services are also furnished by providers of 
outpatient therapy services such as hospitals, SNFs and rehabilitation 
agencies that submit institutional claims, typically representing a 
greater amount of expenditures than practitioners submitting 
professional claims, we calculated additional savings for these 
providers using the same time assumptions of 1 to 1.5 minutes to report 
the HCPCS G-code and modifier

[[Page 36070]]

pair each time functional reporting is required. Our 2017 data show a 
total utilization of the functional reporting HCPCS G-codes is 
29,053,921 single units, or 14,526,961 pairs, indicating that therapy 
providers would have collectively saved between 242,116 to 363,174 
hours (or 14,526,961 to 21,790,442 minutes) for CY 2017 if the 
functional reporting requirements had not been effective during that 
year.
4. Physician Supervision of Diagnostic Imaging Procedures
    We believe that the proposed changes to the physician supervision 
requirements for RAs furnishing diagnostic imaging procedures in this 
proposed rule as described in section II.F. of this proposed rule may 
significantly reduce burden for physicians. While approximately 215,000 
diagnostic imaging services per year are currently performed that 
require personal supervision, we are not able to determine the number 
of these services that are performed by an RA due to limitations in the 
claims data. As a result, we are not able to quantify the amount of 
time potentially saved by physicians and practitioners under our 
proposal to now require direct supervision of diagnostic imaging 
procedures done by RAs. That said, stakeholders representing the 
practitioner community have indicated that changing the required 
supervision level for RAs will result in a redistribution of workload 
from radiologists to RAs, potentially resulting in improved practice 
efficiency and patient satisfaction. Stakeholders have stated that 
practitioners that utilize RAs have experienced improvements in 
practice efficiency, as use of RAs allows radiologists more time for 
professional services such as interpretation of images, and these 
practitioners cite greater flexibility that results in reduced wait 
times. Furthermore, stakeholders contend that the Medicare supervision 
requirements currently create disincentives to use RAs, as 
practitioners cannot make full use of them for Medicare patients, and 
this proposed change to the supervision requirement would allow RAs to 
be more fully utilized. For these reasons, we believe our proposal will 
contribute to burden reduction for physicians and practitioners 
providing diagnostic imaging procedures for Medicare beneficiaries.
5. Beneficiary Liability
    Many proposed policy changes could result in a change in 
beneficiary liability as it relates to coinsurance (which is 20 percent 
of the fee schedule amount, if applicable for the particular provision 
after the beneficiary has met the deductible). To illustrate this 
point, as shown in our public use file Impact on Payment for Selected 
Procedures available on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/, the CY 2018 
national payment amount in the nonfacility setting for CPT code 99203 
(Office/outpatient visit, new) was $109.80, which means that in CY 
2018, a beneficiary would be responsible for 20 percent of this amount, 
or $21.96. Based on this proposed rule, using the CY 2019 CF, the CY 
2019 national payment amount in the nonfacility setting for CPT code 
99203, as shown in the Impact on Payment for Selected Procedures table, 
is $134.45, which means that, in CY 2019, the final beneficiary 
coinsurance for this service would be $26.89.

H. Impact on Beneficiaries in the Quality Payment Program

    There are several changes in this rule that would have an effect on 
beneficiaries. In general, we believe that many of these changes, 
including those intended to improve accuracy in payment through regular 
updates to the inputs used to calculate payments under the Physician 
Fee Schedule, would have a positive impact and improve the quality and 
value of care provided to Medicare beneficiaries. For example, several 
of the new proposed measures include patient-reported outcomes, which 
may be used to help patients make more informed decisions about 
treatment options. Patient-reported outcome measures provide 
information on a patient's health status from the patient's point of 
view and may also provide valuable insights on factors such as quality 
of life, functional status, and overall disease experience, which may 
not otherwise be available through routine clinical data collection. 
Patient-reported outcomes are factors frequently of interest to 
patients when making decisions about treatment.\71\ Further, the 
proposed policy changes in the Promoting Interoperability performance 
category shifts the focus to the interoperable, seamless exchange of 
electronic information. With the requirement that program participants 
use 2015 Edition CEHRT, the interoperable exchange of patient health 
information should be easier because the certification criteria are 
designed to facilitate information exchange. In combination with the 
newly proposed Promoting Interoperability measure to receive and 
incorporate health information, beneficiaries should begin to 
experience improved care coordination and care transitions because 
clinicians have improved access to the beneficiaries' health 
information across the spectrum of care.
---------------------------------------------------------------------------

    \71\ Institute of Medicine. 2013. Delivering High-Quality Cancer 
Care: Charting a New Course for a System in Crisis. Washington, DC: 
The National Academies Press. https://doi.org/10.17226/18359.
---------------------------------------------------------------------------

Impact on Other Health Care Programs and Providers
    We estimate that CY 2019 Quality Payment Program will not have a 
significant economic effect on eligible clinicians and groups and 
believe that MIPS policies, along with increasing participation in APMs 
over time may succeed in improving quality and reducing costs. This may 
in turn result in beneficial effects on both patients and some 
clinicians, and we intend to continue focusing on clinician-driven, 
patient-centered care.

I. Estimating Regulatory Familiarization Costs

    If regulations impose administrative costs on private entities, 
such as the time needed to read and interpret this rule, we should 
estimate the cost associated with regulatory review. Due to the 
uncertainty involved with accurately quantifying the number of entities 
that will review the rule, we assume that the total number of unique 
commenters on last year's rule will be the number of reviewers of this 
rule. We acknowledge that this assumption may understate or overstate 
the costs of reviewing this rule. It is possible that not all 
commenters reviewed last year's rule in detail, and it is also possible 
that some reviewers chose not to comment on the rule. For these reasons 
we thought that the number of past commenters would be a fair estimate 
of the number of reviewers of this rule. We welcomed any comments on 
the approach in estimating the number of entities which will review 
this rule.
    We also recognize that different types of entities are in many 
cases affected by mutually exclusive sections of this rule, and 
therefore for the purposes of our estimate we assume that each reviewer 
reads approximately 50 percent of the rule. We sought comments on this 
assumption.
    Using the wage information from the BLS for medical and health 
service managers (Code 11-9111), we estimate that the cost of reviewing 
this rule is $107.38 per hour, including overhead and fringe benefits 
https://www.bls.gov/oes/current/oes_nat.htm. Assuming an average 
reading speed, we estimate that it would take approximately 8.0 hours

[[Page 36071]]

for the staff to review half of this rule. For each facility that 
reviews the rule, the estimated cost is $859.04 (8.0 hours x $107.38). 
Therefore, we estimated that the total cost of reviewing this 
regulation is $5,105,275 ($859.04 x 5,943 reviewers).

J. Accounting Statement

    As required by OMB Circular A-4 (available at https://www.whitehouse.gov/omb/circulars/a004/a-4.pdf), in Tables 98 and 99 
(Accounting Statements), we have prepared an accounting statement. This 
estimate includes growth in incurred benefits from CY 2018 to CY 2019 
based on the FY 2019 President's Budget baseline.

Table 99--Accounting Statement: Classification of Estimated Expenditures
------------------------------------------------------------------------
                Category                            Transfers
------------------------------------------------------------------------
CY 2019 Annualized Monetized Transfers.  Estimated increase in
                                          expenditures of $0.3 billion
                                          for PFS CF update.
From Whom To Whom?.....................  Federal Government to
                                          physicians, other
                                          practitioners and providers
                                          and suppliers who receive
                                          payment under Medicare.
------------------------------------------------------------------------


   Table 100--Accounting Statement: Classification of Estimated Costs,
                          Transfer, and Savings
------------------------------------------------------------------------
                Category                             Transfer
------------------------------------------------------------------------
CY 2019 Annualized Monetized Transfers   $0.1 billion.
 of beneficiary cost coinsurance.
From Whom to Whom?.....................  Beneficiaries to Federal
                                          Government.
------------------------------------------------------------------------

L. Conclusion

    The proposed rule proposes to modify the consultation requirement 
in Sec.  414.94(j); therefore, this analysis estimates the impact of 
consultations by ordering professionals. We previously estimated a 
total annual burden of $275,139,000, but estimate this modification 
would decrease burden to an annual cost of $122,508,675. We also 
estimate the broader impacts of this requirement, assuming that some 
ordering professionals will purchase a qualified CDSM with one-time 
maximum cost estimate and annual training and maintenance estimate 
maximum of $394,770,600 annually for 5 years. Still, other ordering 
professionals who do not currently use an EHR system and are subject to 
this program may purchase an EHR system. For all ordering professionals 
subject to this program and estimated to not currently use EHR, an 
estimated annualized cost maximum of $192,641,671.84 over 5 years would 
be incurred for all such ordering professionals to obtain an integrated 
qualified CDSM. We believe that in the beginning of this program, it 
may take longer for a Medicare beneficiary to obtain an order for an 
advanced diagnostic imaging service. As a result of this assumption, we 
have calculated an estimated impact to Medicare beneficiaries of 
$68,001,000 per year with a potential offset of $34,000,500 annually if 
process efficiencies are developed to integrate consultation with a 
qualified CDSM into the existing workflow of ordering an advanced 
diagnostic imaging service. This proposed rule discusses the use of G-
codes and modifiers to report AUC consultation information on claims 
and an alternative reporting method using a UCI. Those estimated 
impacts are discussed previously. We estimate the impact of 
transmitting such additional information on an order for an advanced 
diagnostic imaging service to be $111,884,000 annually. Finally, we 
measure the estimated impact on furnishing professionals and facilities 
of the proposed expansion of the definition of applicable setting in 
Sec.  414.94(b) to be the one-time update to modify billing systems at 
cost of $1,740,640,000. Although the consultation and reporting 
requirements of this program are effective beginning January 1, 2020 
with an Educational and Operations Testing Period, we attempt in this 
analysis to identify areas of potential qualitative benefits to both 
Medicare beneficiaries and the Medicare program.
    The analysis in the previous sections, together with the remainder 
of this preamble, provided an initial Regulatory Flexibility Analysis. 
The previous analysis, together with the preceding portion of this 
preamble, provides a Regulatory Impact Analysis. In accordance with the 
provisions of Executive Order 12866, this regulation was reviewed by 
the Office of Management and Budget.

List of Subjects

42 CFR Part 405

    Administrative practice and procedure, Health facilities, Health 
professions, Kidney diseases, Medical devices, Medicare, Reporting and 
recordkeeping requirements, Rural areas, X-rays.

42 CFR Part 410

    Health facilities, Health professions, Kidney diseases, 
Laboratories, Medicare, Reporting and recordkeeping requirements, Rural 
areas, X-rays.

42 CFR Part 411

    Diseases, Medicare, Reporting and recordkeeping requirements.

42 CFR Part 414

    Administrative practice and procedure, Biologics, Drugs, Health 
facilities, Health professions, Kidney diseases, Medicare, Reporting 
and recordkeeping requirements.

42 CFR Part 415

    Health facilities, Health professions, Medicare, Reporting and 
recordkeeping requirements.

42 CFR Part 495

    Administrative practice and procedure, Health facilities, Health 
maintenance organizations (HMO), Health professions, Health records, 
Medicaid, Medicare, Penalties, Reporting and recordkeeping 
requirements.

    For the reasons set forth in the preamble, the Centers for Medicare 
& Medicaid Services proposes to amend 42 CFR chapter IV as set forth 
below:

PART 405--FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED

0
1. The authority citation for part 405 continues to read as follows:


[[Page 36072]]


    Authority:  Secs. 205(a), 1102, 1142, 1861, 1862(a), 1869, 1871, 
1874, 1881, and 1886(k) of the Social Security Act (42 U.S.C. 
405(a), 1302, 1320b-12, 1395x, 1395y(a), 1395ff, 1395hh, 1395kk, 
1395rr, and 1395ww(k)), and sec. 353 of the Public Health Service 
Act (42 U.S.C. 263a).

0
2. Section 405.2401 is amended in paragraph (b) by--
0
a. Revising the introductory text of the definition of ``Federally 
qualified health center''; and
0
b. Revising the definition of ``Secretary''.
    The revisions read as follows:


Sec.  405.2401  Scope and definitions.

* * * * *
    (b) * * *
    Federally qualified health center (FQHC) means an entity that has 
entered into an agreement with CMS to meet Medicare program 
requirements under Sec.  405.2434 and--
* * * * *
    Secretary means the Secretary of Health and Human Services or his 
or her delegate.
* * * * *
0
3. Section 405.2464 is amended by--
0
a. Revising paragraphs (a)(1), (b) heading, and (b)(1);
0
b. Redesignating paragraphs (c) and (d) as paragraphs (d) and (e), 
respectively;
0
c. Adding a new paragraph (c); and
0
d. Revising newly redesignated paragraphs (d) and (e).
    The revisions and additions read as follows:


Sec.  405.2464  Payment rate.

    (a) Payment rate for RHCs that are authorized to bill under the 
reasonable cost system. (1) Except as specified in paragraphs (d) and 
(e) of this section, an RHC that is authorized to bill under the 
reasonable cost system is paid an all-inclusive rate that is determined 
by the MAC at the beginning of the cost reporting period.
* * * * *
    (b) Payment rate for FQHCs that are authorized to bill under the 
prospective payment system. (1) Except as specified in paragraphs (d) 
and (e) of this section, a per diem rate is calculated by CMS by 
dividing total FQHC costs by total FQHC daily encounters to establish 
an average per diem cost.
* * * * *
    (c) Payment for FQHCs that are authorized to bill as grandfathered 
tribal FQHCs. Grandfathered tribal FQHCs are paid at the outpatient per 
visit rate for Medicare as set annually by the Indian Health Service 
for each beneficiary visit for covered services. There are no 
adjustments to this rate.
    (d) Payment for care management services. For chronic care 
management services furnished between January 1, 2016 and December 31, 
2017, payment to RHCs and FQHCs is at the physician fee schedule 
national non-facility payment rate. For care management services 
furnished on or after January 1, 2018, payment to RHCs and FQHCs is at 
the rate set for each of the RHC and FQHC payment codes for care 
management services.
    (e) Payment for communication technology-based and remote 
evaluation services. For communication technology-based and remote 
evaluation services furnished on or after January 1, 2019, payment to 
RHCs and FQHCs is at the rate set for each of the RHC and FQHC payment 
codes for communication technology-based and remote evaluation 
services.

PART 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS

0
4. The authority citation for part 410 continues to read as follows:

    Authority:  Secs. 1102, 1834, 1871, 1881, and 1893 of the Social 
Security Act (42 U.S.C. 1302, 1395m, 1395hh, 1395rr, and 1395ddd).

0
5. Section 410.32 is amended by adding paragraph (b)(4) to read as 
follows:


Sec.  410.32  Diagnostic x-ray tests, diagnostic laboratory tests, and 
other diagnostic tests: Conditions.

* * * * *
    (b) * * *
    (4) Supervision requirement for RRA or RPA. Diagnostic tests that 
are performed by a registered radiologist assistant (RRA) who is 
certified and registered by the American Registry of Radiologic 
Technologists or a radiology practitioner assistant (RPA) who is 
certified by the Certification Board for Radiology Practitioner 
Assistants, require only a direct level of physician supervision, as 
permitted by state law and state scope of practice regulations.
* * * * *


Sec.  410.59   [Amended]

0
6. Section 410.59 is amended by removing paragraph (a)(4).


Sec.  410.60   [Amended]

0
7. Section 410.60 is amended by removing paragraph (a)(4).
0
8. Section 410.61 is amended by revising paragraph (c) to read as 
follows:


Sec.  410.61  Plan of treatment requirements for outpatient 
rehabilitation services.

* * * * *
    (c) Content of the plan. The plan prescribes the type, amount, 
frequency, and duration of the physical therapy, occupational therapy, 
or speech-language pathology services to be furnished to the 
individual, and indicates the diagnosis and anticipated goals.
* * * * *


Sec.  410.62   [Amended]

0
9. Section 410.62 is amended by removing paragraph (a)(4).
0
10. Section 410.78 is amended by--
0
a. Adding paragraphs (b)(3)(ix), (x), and (xi);
0
b. Revising paragraph (b)(4) introductory text, and
0
c. Adding paragraph (b)(4)(iv).
    The additions and revision read as follows:


Sec.  410.78  Telehealth services.

* * * * *
    (b) * * *
    (3) * * *
    (ix) A renal dialysis facility (only for purposes of the home 
dialysis monthly ESRD-related clinical assessment in section 
1881(b)(3)(B) of the Act).
    (x) The home of an individual (only for purposes of the home 
dialysis ESRD-related clinical assessment in section 1881(b)(3)(B) of 
the Act).
    (xi) A mobile stroke unit (only for purposes of diagnosis, 
evaluation, or treatment of symptoms of an acute stroke provided in 
accordance with section 1834(m)(6) of the Act).
    (4) Except as provided in paragraph (b)(4)(iv) of this section, 
originating sites must be:
* * * * *
    (iv) The geographic requirements specified in paragraph (b)(4) of 
this section do not apply to the following telehealth services:
    (A) Home dialysis monthly ESRD-related clinical assessment services 
furnished on or after January 1, 2019, at an originating site described 
in paragraph (b)(3)(vi), (ix) or (x) of this section, in accordance 
with section 1881(b)(3)(B) of the Act; and
    (B) Services furnished on or after January 1, 2019, for purposes of 
diagnosis, evaluation, or treatment of symptoms of an acute stroke.
* * * * *


Sec.  410.105   [Amended]

0
11. Section 410.105 is amended--
0
a. In paragraph (c)(1)(ii) by removing the phrase ``that are consistent 
with the patient function reporting on the claims for services''; and
0
b. By removing paragraph (d).

[[Page 36073]]

PART 411--EXCLUSIONS FROM MEDICARE AND LIMITATIONS ON MEDICARE 
PAYMENT

0
12. The authority citation for part 411 continues to read as follows:

    Authority:  Secs. 1102, 1860D-1 through 1860D-42, 1871, and 1877 
of the Social Security Act (42 U.S.C. 1302, 1395w-101 through 1395w-
152, 1395hh, and 1395nn).

0
13. Section 411.353 is amended by--
0
a. Revising paragraph (g)(1); and
0
b. Removing and reserving paragraph (g)(2).
    The revision reads as follows:


Sec.  411.353  Prohibition on certain referrals by physicians and 
limitations on billing.

* * * * *
    (g) * * *
    (1) An entity may submit a claim or bill and payment may be made to 
an entity that submits a claim or bill for a designated health service 
if--
    (i) The compensation arrangement between the entity and the 
referring physician fully complies with an applicable exception in this 
subpart except with respect to the signature requirement of the 
exception; and
    (ii) The parties obtain the required signature(s) within 90 
consecutive calendar days immediately following the date on which the 
compensation arrangement became noncompliant and the compensation 
arrangement otherwise complies with all criteria of the applicable 
exception.
    (2) [Reserved]
0
14. Section 411.354 is amended by adding paragraph (e) to read as 
follows:


Sec.  411.354  Financial relationship, compensation, and ownership or 
investment interest.

* * * * *
    (e) Special rule on compensation arrangements--(1) Application. 
This paragraph (e) applies only to compensation arrangements as defined 
in section 1877 of the Act and this subpart.
    (2) Writing requirement. In the case of any requirement in this 
subpart for a compensation arrangement to be in writing, such 
requirement may be satisfied by a collection of documents, including 
contemporaneous documents evidencing the course of conduct between the 
parties.

PART 414--PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES

0
15. The authority citation for part 414 continues to read as follows:

    Authority:  Secs. 1102, 1871, and 1881(b)(l) of the Social 
Security Act (42 U.S.C. 1302, 1395hh, and 1395rr(b)(l)).

0
16. Section 414.65 is amended by--
0
a. Revising paragraph (a) introductory text;
0
b. Removing paragraph (a)(1);
0
c. Redesignating paragraphs (a)(2) and (3) as paragraphs (a)(1) and 
(2), respectively; and
0
d. Adding paragraph (b)(3).
    The revision and addition reads as follows:


Sec.  414.65  Payment for telehealth services.

    (a) Professional service. The Medicare payment amount for 
telehealth services described under Sec.  410.78 of this chapter is 
equal to the current fee schedule amount applicable for the service of 
the physician or practitioner, subject to paragraphs (a)(1) and (2) of 
this section, but must be made in accordance with the following 
limitations:
* * * * *
    (b) * * *
    (3) No originating site facility fee payment is made to an 
originating site described in Sec.  410.78(b)(3)(x) or (xi) of this 
chapter; or to an originating site for services furnished under the 
exception at Sec.  410.78(b)(4)(iv)(A) or (B) of this chapter.
* * * * *
0
17. Section 414.94 is amended:
0
a. In paragraph (b), revising the definition of ``Applicable setting''; 
and
0
b. Revising paragraphs (i)(3), (j), and (k) introductory text.
    The revisions read as follows:


Sec.  414.94  Appropriate use criteria for advanced diagnostic imaging 
services.

* * * * *
    (b) * * *
    Applicable setting means a physician's office, a hospital 
outpatient department (including an emergency department), an 
ambulatory surgical center, an independent diagnostic testing facility, 
and any other provider-led outpatient setting determined appropriate by 
the Secretary.
* * * * *
    (i) * * *
    (3) Significant hardships for ordering professionals who experience 
any of the following:
    (i) Insufficient internet access.
    (ii) EHR or CDSM vendor issues.
    (iii) Extreme and uncontrollable circumstances.
    (j) Consulting. (1) Ordering Professionals and, when performed as 
an ``incident to'' service, auxiliary personnel must consult specified 
applicable AUC through qualified CDSMs for applicable imaging services 
furnished in an applicable setting, paid for under an applicable 
payment system, and ordered on or after January 1, 2020.
    (2) The AUC consultation specified in this paragraph (j) may be 
performed by auxiliary personnel (as defined in Sec.  410.26(a)(1) of 
this chapter) under the direction of, and incident to, the ordering 
professional's services.
    (k) Reporting. The following information must be reported on 
Medicare claims for advanced diagnostic imaging services furnished in 
an applicable setting, paid for under an applicable payment system 
defined in paragraph (b) of this section, and ordered on or after 
January 1, 2020.
* * * * *
0
18. Section 414.502 is amended in the definition of ``Applicable 
laboratory'' by revising paragraph (3) introductory text to read as 
follows:


Sec.  414.502  Definitions.

* * * * *
    Applicable laboratory * * *
    (3) In a data collection period, receives more than 50 percent of 
its Medicare revenues, which includes fee-for-service payments under 
Medicare Parts A and B, prescription drug payments under Medicare Part 
D, and any associated Medicare beneficiary deductible or coinsurance 
for services furnished during the data collection period from one or a 
combination of the following sources:
* * * * *


Sec.  414.610   [Amended]

0
19. Section 414.610 is amended:
0
a. In paragraphs (c)(1)(ii) introductory text and (c)(5)(ii) by 
removing the date ``December 31, 2017'' and adding in its place the 
date ``December 31, 2022''; and
0
b. By revising paragraph (c)(8).
    The revision reads as follows:


Sec.  414.610  Basis of payment.

* * * * *
    (c) * * *
    (8) Transport of an individual with end-stage renal disease for 
renal dialysis services. For ambulance services furnished during the 
period October 1, 2013 through September 30, 2018, consisting of non-
emergency basic life support (BLS) services involving transport of an 
individual with end-stage renal disease for renal dialysis services (as 
described in section 1881(b)(14)(B)) furnished other than on an 
emergency basis by a provider of services or a renal dialysis facility, 
the fee schedule amount otherwise applicable (both base rate and 
mileage) is reduced by 10 percent. For such services furnished on or 
after October 1, 2018, the fee schedule amount

[[Page 36074]]

otherwise applicable (both base rate and mileage) is reduced by 23 
percent.
* * * * *


Sec.  414.904   [Amended]

0
20. Section 414.904 is amended in paragraph (e)(4) by removing the 
phrase ``acquisition cost or the applicable Medicare Part B drug 
payment'' and adding in its place the phrase ``acquisition cost or the 
Medicare Part B drug payment''.
0
21. Section 414.1305 is amended by--
0
a. Revising the definition of ``Ambulatory Surgical Center (ASC)-based 
MIPS eligible clinician'';
0
b. Adding in alphabetical order definitions for ``Collection type'' and 
``Health IT vendor'';
0
c. Revising the definitions of ``High priority measure'', ``Hospital-
based MIPS eligible clinician'', and ``Low volume threshold'';
0
d. Adding in alphabetical order a definition for ``MIPS determination 
period'';
0
e. Revising the definitions of ``MIPS eligible clinician'', ``Non-
patient facing MIPS eligible clinician'', ``Qualified Clinical Data 
Registry (QCDR)'', ``Qualifying APM Participant (QP)'', and ``Small 
practice''; and
0
f. Adding in alphabetical order a definition for ``Submission type'', 
``Submitter type'', and ``Third party intermediary''.
    The revisions and additions read as follows:


Sec.  414.1305  Definitions.

* * * * *
    Ambulatory Surgical Center (ASC)-based MIPS eligible clinician 
means:
    (1) For the 2019 and 2020 MIPS payment years, a MIPS eligible 
clinician who furnishes 75 percent or more of his or her covered 
professional services in sites of service identified by the Place of 
Service (POS) codes used in the HIPAA standard transaction as an 
ambulatory surgical center setting based on claims for a period prior 
to the performance period as specified by CMS; and
    (2) Beginning with the 2021 MIPS payment year, a MIPS eligible 
clinician who furnishes 75 percent or more of his or her covered 
professional services in sites of service identified by the POS) codes 
used in the HIPAA standard transaction as an ambulatory surgical center 
setting based on claims for the MIPS determination period.
* * * * *
    Collection type means a set of quality measures with comparable 
specifications and data completeness criteria, including, as 
applicable: Electronic clinical quality measures (eCQMs); MIPS Clinical 
Quality Measures (MIPS CQMs), QCDR measures, Medicare Part B claims 
measures, the CMS Web Interface measures, the CAHPS for MIPS survey, 
and administrative claims measures.
* * * * *
    Health IT vendor means an entity that supports the health IT 
requirements on behalf of a MIPS eligible clinician (including 
obtaining data from a MIPS eligible clinician's CEHRT).
* * * * *
    High priority measure means:
    (1) For the 2019 and 2020 MIPS payment years, an outcome (including 
intermediate-outcome and patient-reported outcome), appropriate use, 
patient safety, efficiency, patient experience, or care coordination 
quality measure.
    (2) Beginning with the 2021 MIPS payment year, an outcome 
(including intermediate-outcome and patient-reported outcome), 
appropriate use, patient safety, efficiency, patient experience, care 
coordination, or opioid-related quality measure.
    Hospital-based MIPS eligible clinician means:
    (1) For the 2019 and 2020 MIPS payment years, a MIPS eligible 
clinician who furnishes 75 percent or more of his or her covered 
professional services in sites of service identified by the Place of 
Service (POS) codes used in the HIPAA standard transaction as an 
inpatient hospital, on-campus outpatient hospital, off campus-
outpatient hospital, or emergency room setting based on claims for a 
period prior to the performance period as specified by CMS; and
    (2) Beginning with the 2021 MIPS payment year, a MIPS eligible 
clinician who furnishes 75 percent or more of his or her covered 
professional services in sites of service identified by the POS codes 
used in the HIPAA standard transaction as an inpatient hospital, on-
campus outpatient hospital, off campus outpatient hospital, or 
emergency room setting based on claims for the MIPS determination 
period.
* * * * *
    Low-volume threshold means:
    (1) For the 2019 MIPS payment year, the low-volume threshold that 
applies to an individual eligible clinician or group that, during the 
low-volume threshold determination period described in paragraph (4) of 
this definition, has Medicare Part B allowed charges less than or equal 
to $30,000 or provides care for 100 or fewer Medicare Part B-enrolled 
individuals.
    (2) For the 2020 MIPS payment year, the low-volume threshold that 
applies to an individual eligible clinician or group that, during the 
low-volume threshold determination period described in paragraph (4) of 
this definition, has allowed charges for covered professional services 
less than or equal to $90,000 or furnishes covered professional 
services to 200 or fewer Medicare Part B-enrolled individuals.
    (3) Beginning with the 2021 MIPS payment year, the low-volume 
threshold that applies to an individual eligible clinician or group 
that, during the MIPS determination period, has allowed charges for 
covered professional services less than or equal to $90,000, furnishes 
covered professional services to 200 or fewer Medicare Part B-enrolled 
individuals, or furnishes 200 or fewer covered professional services to 
Medicare Part B-enrolled individuals.
    (4) For the 2019 and 2020 MIPS payment years, the low-volume 
threshold determination period is a 24-month assessment period 
consisting of:
    (i) An initial 12-month segment that spans from the last 4 months 
of the calendar year 2 years prior to the performance period through 
the first 8 months of the calendar year preceding to the performance 
period; and
    (ii) A second 12-month segment that spans from the last 4 months of 
the calendar year 1 year prior to the performance period through the 
first 8 months of the calendar year performance period. An individual 
eligible clinician or group that is identified as not exceeding the 
low-volume threshold during the initial 12-month segment will continue 
to be excluded under Sec.  414.1310(b)(1)(iii) for the applicable year 
regardless of the results of the second 12-month segment analysis. For 
the 2019 MIPS payment year, each segment of the low-volume threshold 
determination period includes a 60-day claims run out. For the 2020 
MIPS payment year, each segment of the low-volume threshold 
determination period includes a 30-day claims run out.
* * * * *
    MIPS determination period means:
    (1) Beginning with the 2021 MIPS payment year and future years, a 
24-month assessment period consisting of:
    (i) An initial 12-month segment beginning on October 1 of the 
calendar year 2 years prior to the applicable performance period and 
ending on September 30 of the calendar year preceding the applicable 
performance period, and that includes a 30-day claims run out; and
    (ii) A second 12-month segment beginning on October 1 of the 
calendar year preceding the applicable performance period and ending on 
September 30 of the calendar year in which the applicable performance 
period occurs.

[[Page 36075]]

    (2) Subject to Sec.  414.1310(b)(1)(iii), an individual eligible 
clinician or group that is identified as not exceeding the low-volume 
threshold or as a certain type of MIPS eligible clinician during the 
first segment of the MIPS determination period will continue to be 
identified as such for the applicable MIPS payment year regardless of 
the results of the second segment of the MIPS determination period. An 
individual eligible clinician or group for which the unique billing TIN 
and NPI combination is established during the second segment of the 
MIPS determination period will be assessed based solely on the results 
of that segment.
    MIPS eligible clinician as identified by a unique billing TIN and 
NPI combination used to assess performance, means any of the following 
(except as excluded under Sec.  414.1310(b)):
    (1) For the 2019 and 2020 MIPS payment years:
    (i) A physician (as defined in section 1861(r) of the Act);
    (ii) A physician assistant, a nurse practitioner, and clinical 
nurse specialist (as such terms are defined in section 1861(aa)(5) of 
the Act);
    (iii) A certified registered nurse anesthetist (as defined in 
section 1861(bb)(2) of the Act); and
    (iv) A group that includes such clinicians.
    (2) For the 2021 MIPS payment year and future years:
    (i) A clinician described in paragraph (1) of this definition;
    (ii) A physical therapist or occupational therapist;
    (iii) A clinical social worker (as defined in section 1861(hh)(1) 
of the Act);
    (iv) A clinical psychologist (as defined by the Secretary for 
purposes of section 1861(ii) of the Act); and
    (v) A group that includes such clinicians.
* * * * *
    Non-patient facing MIPS eligible clinician means:
    (1) For the 2019 and 2020 MIPS payment year, an individual MIPS 
eligible clinician who bills 100 or fewer patient facing encounters 
(including Medicare telehealth services defined in section 1834(m) of 
the Act), as described in paragraph (3) of this definition, during the 
non-patient facing determination period described in paragraph (4) of 
this definition, and a group or virtual group provided that more than 
75 percent of the NPIs billing under the group's TIN or virtual group's 
TINs, as applicable, meet the definition of a non-patient facing 
individual MIPS eligible clinician during the non-patient facing 
determination period described in paragraph (4) of this definition.
    (2) Beginning with the 2021 MIPS payment year, an individual MIPS 
eligible clinician who bills 100 or fewer patient facing encounters 
(including Medicare telehealth services defined in section 1834(m) of 
the Act), as described in paragraph (3) of this definition, during the 
MIPS determination period, and a group or virtual group provided that 
more than 75 percent of the NPIs billing under the group's TIN or 
virtual group's TINs, as applicable, meet the definition of a non-
patient facing individual MIPS eligible clinician during the MIPS 
determination period.
    (3) For purposes of this definition, a patient-facing encounter is 
an instance in which the individual MIPS eligible clinician or group 
bills for items and services furnished such as general office visits, 
outpatient visits, and procedure codes under the PFS, as specified by 
CMS.
    (4) For the 2019 and 2020 MIPS payment year, the non-patient facing 
determination period is a 24-month assessment period consisting of:
    (i) An initial 12-month segment that spans from the last 4 months 
of the calendar year 2 years prior to the performance period through 
the first 8 months of the calendar year preceding the performance 
period; and
    (ii) A second 12-month segment that spans from the last 4 months of 
the calendar year 1 year prior to the performance period through the 
first 8 months of the calendar year performance period. An individual 
eligible MIPS clinician, group, or virtual group that is identified as 
non-patient facing during the initial 12-month segment will continue to 
be considered non-patient facing for the applicable year regardless of 
the results of the second 12-month segment analysis. For the 2019 MIPS 
payment year, each segment of the non-patient facing determination 
period includes a 60-day claims run out. For the 2020 MIPS payment year 
and future years, each segment of the non-patient facing determination 
period includes a 30-day claims run out.
* * * * *
    Qualified Clinical Data Registry (QCDR) means an entity with 
clinical expertise in medicine and quality measurement development that 
collects medical or clinical data on behalf of a MIPS eligible 
clinician for the purpose of patient and disease tracking to foster 
improvement in the quality of care provided to patients.
* * * * *
    Qualifying APM Participant (QP) means an eligible clinician 
determined by CMS to have met or exceeded the relevant QP payment 
amount or QP patient count threshold under Sec.  414.1430(a)(1), 
(a)(3), (b)(1), or (b)(3) for a year based on participation in an APM 
Entity that is also participating in an Advanced APM.
* * * * *
    Small practice means:
    (1) For the 2019 MIPS payment year, a TIN consisting of 15 or fewer 
eligible clinicians.
    (2) For the 2020 MIPS payment year, a TIN consisting of 15 or fewer 
eligible clinicians during a 12-month assessment period that spans from 
the last 4 months of the calendar year 2 years prior to the performance 
period through the first 8 months of the calendar year preceding the 
performance period and includes a 30-day claims run out.
    (3) Beginning with the 2021 MIPS payment year, a TIN consisting of 
15 or fewer eligible clinicians during the MIPS determination period.
* * * * *
    Submission type means the mechanism by which the submitter type 
submits data to CMS, including, as applicable: Direct, log in and 
upload, log in and attest, Medicare Part B claims and the CMS Web 
Interface.
    Submitter type means the MIPS eligible clinician, group, or third 
party intermediary acting on behalf of a MIPS eligible clinician or 
group, as applicable, that submits data on measures and activities 
under MIPS.
    Third party intermediary means an entity that has been approved 
under Sec.  414.1400 to submit data on behalf of a MIPS eligible 
clinician, group, or virtual group for one or more of the quality, 
improvement activities, and promoting interoperability performance 
categories.
* * * * *
0
22. Section 414.1310 is amended by revising paragraphs (a), (b)(1)(ii) 
and (iii), (d), and (e)(1) and (2) to read as follows:


Sec.  414.1310  Applicability.

    (a) Program implementation. Except as specified in paragraph (b) of 
this section, MIPS applies to payments for covered professional 
services furnished by MIPS eligible clinicians on or after January 1, 
2019.
    (b) * * *
    (1) * * *
    (ii) Is a Partial Qualifying APM Participant and does not elect to

[[Page 36076]]

participate in MIPS as a MIPS eligible clinician; or
    (iii) Does not exceed the low-volume threshold. Beginning with the 
2021 MIPS payment year, if an individual eligible clinician, group, or 
APM Entity group in a MIPS APM exceeds at least one, but not all, of 
the low-volume threshold criteria and elects to participate in MIPS as 
a MIPS eligible clinician, the individual eligible clinician, group, or 
APM Entity group is treated as a MIPS eligible clinician for the 
applicable MIPS payment year. For APM Entity groups in MIPS APMs, only 
the APM Entity group election can result in the APM Entity group being 
treated as MIPS eligible clinicians for the applicable payment year.
* * * * *
    (d) Clarification. In no case will a MIPS payment adjustment factor 
(or additional MIPS payment adjustment factor) apply to payments for 
items and services furnished during a year by a eligible clinician, 
including an eligible clinician described in paragraph (b) or (c) of 
this section, who is not a MIPS eligible clinician, including an 
eligible clinician who voluntarily reports on applicable measures and 
activities under MIPS.
    (e) Requirements for groups. (1) Except as provided under Sec.  
414.1370(f)(2), each MIPS eligible clinician in the group will receive 
a MIPS payment adjustment factor (or additional MIPS payment adjustment 
factor) based on the group's combined performance assessment.
    (2) For individual MIPS eligible clinicians to participate in MIPS 
as a group, all of the following requirements must be met:
    (i) Groups must meet the definition of a group at all times during 
the applicable performance period.
    (ii) Individual eligible clinicians that elect to participate in 
MIPS as a group must aggregate their performance data across the 
group's TIN.
    (iii) Individual eligible clinicians that elect to participate in 
MIPS as a group will have their performance assessed at the group level 
across all four MIPS performance categories.
    (iv) Groups must adhere to an election process established by CMS, 
as applicable.
* * * * *
0
23. Section 414.1315 is revised to read as follows:


Sec.  414.1315  Virtual groups.

    (a) Eligibility. (1) For a MIPS payment year, a solo practitioner 
or a group of 10 or fewer eligible clinicians may elect to participate 
in MIPS as a virtual group with at least one other such solo 
practitioner or group. The election must be made prior to the start of 
the applicable performance period and cannot be changed during the 
performance period. A solo practitioner or group may elect to be in no 
more than one virtual group for a performance period, and, in the case 
of a group, the election applies to all MIPS eligible clinicians in the 
group.
    (2) Except as provided under Sec.  414.1370(f)(2), each MIPS 
eligible clinician in the virtual group will receive a MIPS payment 
adjustment factor (or additional MIPS payment adjustment factor) based 
on the virtual group's combined performance assessment.
    (b) Election deadline. The election deadline is December 31 of the 
calendar year preceding the applicable performance period.
    (c) Election process. For the 2020 MIPS payment year and future 
years, the virtual group election process is as follows:
    (1) Stage 1: Virtual group eligibility determination. (i) For the 
2020 MIPS payment year, the virtual group eligibility determination 
period is an assessment period of up to 5 months beginning on July 1 
and ending as late as November 30 of the calendar year preceding the 
applicable performance period, and that includes a 30-day claims run 
out.
    (ii) Beginning with the 2021 MIPS payment year, the virtual group 
eligibility determination period aligns with the first segment of the 
MIPS determination period, which is a 12-month assessment period 
beginning on October 1 of the calendar year 2 years prior to the 
applicable performance period and ending on September 30 of the 
calendar year preceding the applicable performance period, and that 
includes a 30-day claims run out.
    (2) Stage 2: Virtual group formation. (i) Solo practitioners and 
groups that elect to participate in MIPS as a virtual group must 
establish a formal written agreement that satisfies paragraph (c)(3) of 
this section prior to the election.
    (ii) A designated virtual group representative must submit an 
election, on behalf of the solo practitioners and groups that compose a 
virtual group, to participate in MIPS a virtual group for a performance 
period in a form and manner specified by CMS by the election deadline 
specified in paragraph (b) of this section.
    (iii) The virtual group election must include each TIN and NPI 
associated with the virtual group and contact information for the 
virtual group representative.
    (iv) Once an election is made, the virtual group representative 
must contact their designated CMS contact to update any election 
information that changed during a performance period at least one time 
prior to the start of an applicable submission period.
    (3) Virtual group agreement. The virtual group arrangement must be 
set forth in a formal written agreement among the parties, consisting 
of each solo practitioner and group that composes a virtual group. The 
agreement must comply with the following requirements:
    (i) Identifies each party by name, TIN, and each NPI under the TIN, 
and includes as parties only the solo practitioners and groups that 
compose the virtual group.
    (ii) Is for a term of at least one performance period.
    (iii) Requires each party to notify each NPI under the party's TIN 
regarding their participation in the MIPS as a virtual group.
    (iv) Sets forth each NPI's rights and obligations in, and 
representation by, the virtual group, but not limited to, the reporting 
requirements and how participation in the MIPS as a virtual group the 
NPI's ability to participate in the MIPS outside of the virtual group.
    (v) Describes how the opportunity to receive payment adjustments 
will encourage each member of the virtual group (and each NPI under 
each TIN in the virtual group) to adhere to quality assurance and 
improvement.
    (vi) Requires each party to update its Medicare enrollment 
information, including the addition or removal of NPIs billing under 
its TIN, on a timely basis in accordance with Medicare program 
requirements and to notify the other parties of any such changes within 
30 days of the change.
    (vii) Requires completion of a close-out process upon termination 
or expiration of the agreement that requires each party to furnish all 
data necessary for the parties to aggregate their data across the 
virtual group's TINs.
    (viii) Expressly requires each party to participate in the MIPS as 
a virtual group and comply with the requirements of the MIPS and all 
other applicable laws (including, but not limited to, Federal criminal 
law, the Federal False Claims Act, the Federal anti-kickback statute, 
the Federal civil monetary penalties law, the Federal physician self-
referral law, and the Health Insurance Portability and Accountability 
Act of 1996).
    (ix) Is executed on behalf of each party by an individual who is 
authorized to bind the party.

[[Page 36077]]

    (d) Virtual group reporting requirements. For solo practitioners 
and groups of 10 or fewer eligible clinicians to participate in MIPS as 
a virtual group, all of the following requirements must be met:
    (1) Virtual groups must meet the definition of a virtual group at 
all times during the applicable performance period.
    (2) Solo practitioners and groups of 10 or fewer eligible 
clinicians that elect to participate in MIPS as a virtual group must 
aggregate their performance data across the virtual group's TINs.
    (3) Solo practitioners and groups of 10 or fewer eligible 
clinicians that elect to participate in MIPS as a virtual group will 
have their performance assessed at the virtual group level across all 
four MIPS performance categories.
    (4) Virtual groups must adhere to the election process described in 
paragraph (c) of this section.
0
24. Section 414.1320 is amended by revising paragraphs (b)(2) and 
(c)(2) and adding paragraphs (d) and (e) to read as follows:


Sec.  414.1320  MIPS performance period.

* * * * *
    (b) * * *
    (2) Promoting Interoperability and improvement activities 
performance categories is a minimum of a continuous 90-day period 
within CY 2018, up to and including the full CY 2018 (January 1, 2018 
through December 31, 2018).
    (c) * * *
    (2) Promoting Interoperability and improvement activities 
performance categories is a minimum of a continuous 90-day period 
within CY 2019, up to and including the full CY 2019 (January 1, 2019 
through December 31, 2019).
    (d) Beginning with the 2022 MIPS payment year, the performance 
period for:
    (1) The quality and cost performance categories is the full 
calendar year (January 1 through December 31) that occurs 2 years prior 
to the applicable MIPS payment year.
    (2) The improvement activities performance categories is a minimum 
of a continuous 90-day period within the calendar year that occurs 2 
years prior to the applicable MIPS payment year, up to and including 
the full calendar year.
    (e) For purposes of the 2022 MIPS payment year, the performance 
period for:
    (1) The Promoting Interoperability performance category is a 
minimum of a continuous 90-day period within the calendar year that 
occurs 2 years prior to the applicable MIPS payment year, up to and 
including the full calendar year.
    (2) [Reserved]
0
25. Section 414.1325 is revised to read as follows:


Sec.  414.1325  Data submission requirements.

    (a) Applicable performance categories. (1) Except as provided in 
paragraph (a)(2) of this section or under Sec.  414.1370, as 
applicable, individual MIPS eligible clinicians and groups must submit 
data on measures and activities for the quality, improvement 
activities, and Promoting Interoperability performance categories in 
accordance with this section. Except for the Medicare Part B claims 
submission type, the data may also be submitted on behalf of the 
individual MIPS eligible clinician or group by a third party 
intermediary described at Sec.  414.1400.
    (2) There are no data submission requirements for:
    (i) The cost performance category or administrative claims-based 
quality measures. Performance in the cost performance category and on 
such measures is calculated by CMS using administrative claims data, 
which includes claims submitted with dates of service during the 
applicable performance period that are processed no later than 60 days 
following the close of the applicable performance period.
    (ii) The quality or cost performance category, as applicable, for 
MIPS eligible clinicians and groups that are scored under the facility-
based measurement scoring methodology described in Sec.  414.1380(e).
    (b) Data submission types for individual MIPS eligible clinicians. 
An individual MIPS eligible clinician may submit their MIPS data using:
    (1) For the quality performance category, the direct, login and 
upload, and Medicare Part B claims (for small practices only beginning 
with the 2021 MIPS payment year) submission types.
    (2) For the improvement activities or Promoting Interoperability 
performance categories, the direct, login and upload, or login and 
attest submission types.
    (c) Data submission types for groups. Groups may submit their MIPS 
data using:
    (1) For the quality performance category, the direct, login and 
upload, Medicare Part B claims (for small practices only beginning with 
the 2021 MIPS payment year), and CMS Web Interface (for groups 
consisting of 25 or more eligible clinicians or a third party 
intermediary submitting on behalf of a group) submission types.
    (2) For the improvement activities or Promoting Interoperability 
performance categories, the direct, login and upload, or login and 
attest submission types.
    (d) Use of multiple data submission types. Beginning with the 2021 
MIPS payment year, MIPS eligible clinicians, groups, and virtual groups 
may submit their MIPS data using multiple data submission types for any 
performance category described in paragraph (a)(1) of this section, as 
applicable; provided, however, that the MIPS eligible clinician, group, 
or virtual group uses the same identifier for all performance 
categories and all data submissions.
    (e) Data submission deadlines. The data submission deadlines are as 
follows:
    (1) For the direct, login and upload, login and attest, and CMS Web 
Interface submission types, March 31 following the close of the 
applicable performance period or a later date as specified by CMS.
    (2) For the Medicare Part B claims submission type, data must be 
submitted on claims with dates of service during the applicable 
performance period that must be processed no later than 60 days 
following the close of the applicable performance period.
0
26. Section 414.1330 is revised to read as follows:


Sec.  414.1330  Quality performance category.

    (a) For a MIPS payment year, CMS uses the following quality 
measures, as applicable, to assess performance in the quality 
performance category:
    (1) Measures included in the MIPS final list of quality measures 
established by CMS through rulemaking;
    (2) QCDR measures approved by CMS under Sec.  414.1400;
    (3) Facility-based measures described in Sec.  414.1380; and
    (4) MIPS APM measures described in Sec.  414.1370.
    (b) Unless a different scoring weight is assigned by CMS, 
performance in the quality performance category comprises:
    (1) 60 percent of a MIPS eligible clinician's final score for MIPS 
payment year 2019.
    (2) 50 percent of a MIPS eligible clinician's final score for MIPS 
payment year 2020.
    (3) 45 percent of a MIPS eligible clinician's final score for MIPS 
payment year 2021.
0
27. Section 414.1335 is amended by revising paragraphs (a)(1), (2), and 
(3) to read as follows:


Sec.  414.1335  Data submission criteria for the quality performance 
category.

    (a) * * *
    (1) For Medicare Part B claims measures, MIPS CQMs, eCQMs, or QCDR 
measures. (i) Subject to paragraph (a)(1)(ii) of this section,

[[Page 36078]]

submit data on at least six measures including at least one outcome 
measure. If an applicable outcome measure is not available, report one 
other high priority measure. If fewer than six measures apply to the 
MIPS eligible clinician or group, report on each measure that is 
applicable.
    (ii) MIPS eligible clinicians and groups that report on a specialty 
or subspecialty measure set, as designated in the MIPS final list of 
quality measures established by CMS through rulemaking, must submit 
data on at least six measures within that set. If the set contains 
fewer than six measures or if fewer than six measures within the set 
apply to the MIPS eligible clinician or group, report on each measure 
that is applicable.
    (2) For CMS Web Interface measures. (i) Report on all measures 
included in the CMS Web Interface. The group must report on the first 
248 consecutively ranked beneficiaries in the sample for each measure 
or module.
    (ii) If the sample of eligible assigned beneficiaries is less than 
248, then the group must report on 100 percent of assigned 
beneficiaries.
    (iii) The group is required to report on at least one measure for 
which there is Medicare patient data.
    (3) For the CAHPS for MIPS survey. (i) For the 12-month performance 
period, a group that wishes to voluntarily elect to participate in the 
CAHPS for MIPS survey must use a survey vendor that is approved by CMS 
for the applicable performance period to transmit survey measures data 
to CMS.
    (ii) [Reserved]
* * * * *
0
28. Section 414.1340 is amended by revising paragraphs (a) introductory 
text, (b) introductory text, and (c) to read as follows:


Sec.  414.1340  Data completeness criteria for the quality performance 
category.

    (a) MIPS eligible clinicians and groups submitting quality measures 
data on QCDR measures, MIPS CQMs, or the eCQMs must submit data on:
* * * * *
    (b) MIPS eligible clinicians and groups submitting quality measure 
data on the Medicare Part B claims measures must submit data on:
* * * * *
    (c) Groups submitting quality measures data on CMS Web Interface 
measures or the CAHPS for MIPS survey, must meet the data submission 
requirement on the sample of the Medicare Part B patients CMS provides.
0
29. Section 414.1350 is revised to read as follows:


Sec.  414.1350  Cost performance category.

    (a) Specification of cost measures. For purposes of assessing 
performance of MIPS eligible clinicians on the cost performance 
category, CMS specifies cost measures for a performance period.
    (b) Attribution. (1) Cost measures are attributed at the TIN/NPI 
level.
    (2) For the total per capita cost measure, beneficiaries are 
attributed using a method generally consistent with the method of 
assignment of beneficiaries under Sec.  425.402 of this chapter.
    (3) For the Medicare Spending per Beneficiary (MSPB) measure, an 
episode is attributed to the MIPS eligible clinician who submitted the 
plurality of claims (as measured by allowed charges) for Medicare Part 
B services rendered during an inpatient hospitalization that is an 
index admission for the MSPB measure during the applicable performance 
period.
    (4) For the acute condition episode-based measures specified for 
the 2017 performance period, an episode is attributed to each MIPS 
eligible clinician who bills at least 30 percent of inpatient 
evaluation and management (E&M) visits during the trigger event for the 
episode.
    (5) For the procedural episode-based measures specified for the 
2017 performance period, an episode is attributed to each MIPS eligible 
clinician who bills a Medicare Part B claim with a trigger code during 
the trigger event for the episode.
    (6) For the acute inpatient medical condition episode-based 
measures specified beginning with the 2019 performance period, an 
episode is attributed to each MIPS eligible clinician who bills 
inpatient E&M claim lines during a trigger inpatient hospitalization 
under a TIN that renders at least 30 percent of the inpatient E&M claim 
lines in that hospitalization.
    (7) For the procedural episode-based measures specified beginning 
with the 2019 performance period, an episode is attributed to each MIPS 
eligible clinician who renders a trigger service as identified by 
HCPCS/CPT procedure codes.
    (c) Case minimums. (1) For the total per capita cost measure, the 
case minimum is 20.
    (2) For the Medicare spending per beneficiary measure, the case 
minimum is 35.
    (3) For the episode-based measures specified for the 2017 
performance period, the case minimum is 20.
    (4) For the procedural episode-based measures specified beginning 
with the 2019 performance period, the case minimum is 10.
    (5) For the acute inpatient medical condition episode-based 
measures specified beginning with the 2019 performance period, the case 
minimum is 20.
    (d) Scoring weight. Unless a different scoring weight is assigned 
by CMS under section 1848(q)(5)(F) of the Act, performance in the cost 
performance category comprises:
    (1) Zero percent of a MIPS eligible clinician's final score for 
MIPS payment year 2019.
    (2) 10 percent of a MIPS eligible clinician's final score for MIPS 
payment year 2020.
    (3) 15 percent of a MIPS eligible clinician's final score for MIPS 
payment year 2021.
0
30. Section 414.1355 is amended by revising paragraphs (a), (b) 
introductory text, and (c) to read as follows:


Sec.  414.1355  Improvement activities performance category.

    (a) For a MIPS payment year, CMS uses improvement activities 
included in the MIPS final inventory of improvement activities 
established by CMS through rulemaking to assess performance in the 
improvement activities performance category.
    (b) Unless a different scoring weight is assigned by CMS under 
section 1848(q)(5)(F) of the Act, performance in the improvement 
activities performance category comprises:
* * * * *
    (c) The following are the list of subcategories, of which, with the 
exception of Participation in an APM, include activities for selection 
by a MIPS eligible clinician or group:
    (1) Expanded practice access, such as same day appointments for 
urgent needs and after-hours access to clinician advice.
    (2) Population management, such as monitoring health conditions of 
individuals to provide timely health care interventions or 
participation in a QCDR.
    (3) Care coordination, such as timely communication of test 
results, timely exchange of clinical information to patients or other 
clinicians, and use of remote monitoring or telehealth.
    (4) Beneficiary engagement, such as the establishment of care plans 
for individuals with complex care needs, beneficiary self-management 
assessment and training, and using shared decision making mechanisms.
    (5) Patient safety and practice assessment, such as through the use 
of clinical or surgical checklists and practice assessments related to 
maintaining certification.
    (6) Participation in an APM.

[[Page 36079]]

    (7) Achieving health equity, such as for MIPS eligible clinicians 
that achieve high quality for underserved populations, including 
persons with behavioral health conditions, racial and ethnic 
minorities, sexual and gender minorities, people with disabilities, 
people living in rural areas, and people in geographic HPSAs.
    (8) Emergency preparedness and response, such as measuring MIPS 
eligible clinician participation in the Medical Reserve Corps, 
measuring registration in the Emergency System for Advance Registration 
of Volunteer Health Professionals, measuring relevant reserve and 
active duty uniformed services MIPS eligible clinician activities, and 
measuring MIPS eligible clinician volunteer participation in domestic 
or international humanitarian medical relief work.
    (9) Integrated behavioral and mental health, such as measuring or 
evaluating such practices as: Co-location of behavioral health and 
primary care services; shared/integrated behavioral health and primary 
care records; cross training of MIPS eligible clinicians, and 
integrating behavioral health with primary care to address substance 
use disorders or other behavioral health conditions, as well as 
integrating mental health with primary care.
0
31. Section 414.1360 is amended by revising paragraph (a)(1) to read as 
follows:


Sec.  414.1360  Data submission criteria for the improvement activities 
performance category.

    (a) * * *
    (1) Via direct, login and upload, and login and attest. For the 
applicable performance period, submit a yes response for each 
improvement activity that is performed for at least a continuous 90-day 
period during the applicable performance period.
* * * * *


Sec.  414.1365   [Removed]

0
32. Section 414.1365 is removed.
0
33. Section 414.1370 is amended by revising paragraphs (b)(3), (f)(2), 
(g)(4), (h)(4) heading, (h)(5)(i)(A) and (B), and (h)(5)(ii) 
introductory text to read as follows:


Sec.  414.1370  APM scoring standard under MIPS.

* * * * *
    (b) * * *
    (3) The APM bases payment on quality measures and cost/utilization; 
and
* * * * *
    (f) * * *
    (2) MIPS eligible clinicians who participate in a group or have 
elected to participate in a virtual group and who are also on a MIPS 
APM Participation List will be included in the assessment under MIPS 
for purposes of producing a group or virtual group score and under the 
APM scoring standard for purposes of producing an APM Entity score. The 
MIPS payment adjustment for these eligible clinicians is based solely 
on their APM Entity score; if the APM Entity group is exempt from MIPS 
all eligible clinicians within that APM Entity group are also exempt 
from MIPS.
    (g) * * *
    (4) Promoting Interoperability (PI). (i) For the 2019 and 2020 MIPS 
payment years, each Shared Savings Program ACO participant TIN must 
report data on the Promoting Interoperability performance category 
separately from the ACO, as specified in Sec.  414.1375(b)(2). The ACO 
participant TIN scores are weighted according to the number of MIPS 
eligible clinicians in each TIN as a proportion of the total number of 
MIPS eligible clinicians in the APM Entity group, and then aggregated 
to determine an APM Entity score for the ACI performance category.
    (ii) For the 2019 and 2020 MIPS payment years, for APM Entities in 
MIPS APMs other than the Shared Savings Program, CMS uses one score for 
each MIPS eligible clinician in the APM Entity group to derive a single 
average APM Entity score for the Promoting Interoperability performance 
category. Beginning with the 2021 MIPS payment year, for APM Entities 
in MIPS APMs including the Shared Savings Program, CMS uses one score 
for each MIPS eligible clinician in the APM Entity group to derive a 
single average APM Entity score for the Promoting Interoperability 
performance category. The score for each MIPS eligible clinician is the 
higher of either:
    (A) A group score based on the measure data for the Promoting 
Interoperability performance category reported by a TIN for the MIPS 
eligible clinician according to MIPS submission and reporting 
requirements for groups; or
    (B) An individual score based on the measure data for the Promoting 
Interoperability performance category reported by the MIPS eligible 
clinician according to MIPS submission and reporting requirements for 
individuals.
    (iii) In the event that a MIPS eligible clinician participating in 
a MIPS APM receives an exception from the Promoting Interoperability 
performance category reporting requirements, such eligible clinician 
will be assigned a null score when CMS calculates the APM Entity's 
Promoting Interoperability performance category score under the APM 
scoring standard.
    (A) If all MIPS eligible clinicians in an APM Entity have been 
excepted from reporting the Promoting Interoperability performance 
category, the performance category weight will be reweighted to zero 
for the APM Entity for that MIPS performance period.
    (B) [Reserved]
    (h) * * *
    (4) Promoting Interoperability. * * *
    (5) * * *
    (i) * * *
    (A) In 2017, the improvement activities performance category is 
reweighted to 25 percent and the Promoting Interoperability performance 
category is reweighted to 75 percent; and
    (B) Beginning in 2018, the Promoting Interoperability performance 
category is reweighted to 75 percent and the improvement activities 
performance category is reweighted to 25 percent.
    (ii) If CMS reweights the Promoting Interoperability performance 
category to zero percent:
* * * * *
0
34. Section 414.1375 is amended by--
0
a. Revising the section heading, paragraphs (a), (b) introductory text, 
and (b)(2); and
0
b. Removing paragraph (b)(3).
    The revisions and addition read as follows:


Sec.  414.1375  Promoting Interoperability (PI) performance category.

    (a) Final score. Unless a different scoring weight is assigned by 
CMS under sections 1848(o)(2)(D), 1848(q)(5)(E)(ii), or 1848(q)(5)(F) 
of the Act, performance in the Promoting Interoperability performance 
category comprises 25 percent of a MIPS eligible clinician's final 
score for each MIPS payment year.
    (b) Reporting for the Promoting Interoperability performance 
category. To earn a performance category score for the Promoting 
Interoperability performance category for inclusion in the final score, 
a MIPS eligible clinician must:
* * * * *
    (2) Report MIPS--Promoting Interoperability objectives and 
measures. Report on the objectives and associated measures as specified 
by CMS for the Promoting Interoperability performance category for the 
performance period as follows:
    (i) For the 2019 and 2020 MIPS payment years: For each base score 
measure, as applicable, report the numerator (of at least one) and 
denominator, or yes/no statement, or claim an exclusion for each 
measure

[[Page 36080]]

that includes an option for an exclusion; and
    (ii) Beginning with the 2021 MIPS payment year:
    (A) Report that the MIPS eligible clinician completed the actions 
included in the Security Risk Analysis measure during the year in which 
the performance period occurs; and
    (B) For each required measure, as applicable, report the numerator 
(of at least one) and denominator, or yes/no statement, or an exclusion 
for each measure that includes an option for an exclusion.
0
35. Section 414.1380 is revised to read as follows:


Sec.  414.1380  Scoring.

    (a) General. MIPS eligible clinicians are scored under MIPS based 
on their performance on measures and activities in four performance 
categories. MIPS eligible clinicians are scored against performance 
standards for each performance category and receive a final score, 
composed of their performance category scores, and calculated according 
to the final score methodology.
    (1) Performance standards. (i) For the quality performance 
category, measures are scored between zero and 10 measure achievement 
points. Performance is measured against benchmarks. Measure bonus 
points are available for submitting high-priority measures, submitting 
measures using end-to-end electronic reporting, and in small practices 
that submit data on at least 1 quality measure. Beginning with the 2020 
MIPS payment year, improvement scoring is available in the quality 
performance category.
    (ii) For the cost performance category, measures are scored between 
1 and 10 points. Performance is measured against a benchmark. Starting 
with the 2024 MIPS payment year, improvement scoring is available in 
the cost performance category.
    (iii) For the improvement activities performance category, each 
improvement activity is assigned a certain number of points. The points 
for all submitted activities are summed and scored against a total 
potential performance category score of 40 points.
    (iv) For the Promoting Interoperability performance category, each 
measure is scored against a maximum number of points. The points for 
all submitted measures are summed and scored against a total potential 
performance category score of 100 points.
    (2) [Reserved]
    (b) Performance categories. MIPS eligible clinicians are scored 
under MIPS in four performance categories.
    (1) Quality performance category--(i) Measure achievement points. 
For the 2019, 2020, and 2021 MIPS payment years, MIPS eligible 
clinicians receive between 3 and 10 measure achievement points 
(including partial points) for each measure required under Sec.  
414.1335 on which data is submitted in accordance with Sec.  414.1325 
that has a benchmark at paragraph (b)(1)(ii) of this section, meets the 
case minimum requirement at paragraph (b)(1)(iii) of this section, and 
meets the data completeness requirement at Sec.  414.1340. The number 
of measure achievement points received for each such measure is 
determined based on the applicable benchmark decile category and the 
percentile distribution. MIPS eligible clinicians receive zero measure 
achievement points for each measure required under Sec.  414.1335 on 
which no data is submitted in accordance with Sec.  414.1325. MIPS 
eligible clinicians that submit data in accordance with Sec.  414.1325 
on a greater number of measures than required under Sec.  414.1335 are 
scored only on the required measures with the greatest number of 
measure achievement points. Beginning with the 2021 MIPS payment year, 
MIPS eligible clinicians that submit data in accordance with Sec.  
414.1325 on a single measure via multiple collection types are scored 
only on the data submission with the greatest number of measure 
achievement points.
    (A) Lack of benchmark or case minimum. (1) Except as provided in 
paragraph (b)(1)(i)(A)(2) of this section, for the 2019, 2020, and 2021 
MIPS payment years, MIPS eligible clinicians receive 3 measure 
achievement points for each submitted measure that meets the data 
completeness requirement, but does not have a benchmark or meet the 
case minimum requirement.
    (2) The following measures are excluded from a MIPS eligible 
clinician's total measure achievement points and total available 
measure achievement points:
    (i) Each submitted CMS Web Interface-based measure that meets the 
data completeness requirement, but does not have a benchmark or meet 
the case minimum requirement, or is redesignated as pay-for-reporting 
for all Shared Savings Program accountable care organizations by the 
Shared Savings Program; and
    (ii) Each administrative claims-based measure that does not have a 
benchmark or meet the case minimum requirement.
    (B) Lack of complete data. (1) Except as provided in paragraph 
(b)(1)(i)(B)(2) of this section, for each submitted measure that does 
not meet the data completeness requirement:
    (i) For the 2019 MIPS payment year, MIPS eligible clinicians 
receive 3 measure achievement points;
    (ii) For the 2020 and 2021 MIPS payment years, MIPS eligible 
clinicians other than small practices receive 1 measure achievement 
point, and small practices receive 3 measure achievement points; and
    (iii) Beginning with the 2022 MIPS payment year, MIPS eligible 
clinicians other than small practices receive zero measure achievement 
points, and small practices receive 3 measure achievement points.
    (2) MIPS eligible clinicians receive zero measure achievement 
points for each submitted CMS Web Interface-based measure that does not 
meet the data completeness requirement.
    (ii) Benchmarks. Benchmarks will be based on collection type, from 
all available sources, including MIPS eligible clinicians and APMs, to 
the extent feasible, during the applicable baseline or performance 
period.
    (A) Each benchmark must have a minimum of 20 individual clinicians 
or groups who reported the measure meeting the case minimum requirement 
at paragraph (b)(1)(iii) of this section and the data completeness 
requirement at Sec.  414.1340 and having a performance rate that is 
greater than zero.
    (B) CMS Web Interface collection type uses benchmarks from the 
corresponding reporting year of the Shared Savings Program.
    (iii) Minimum case requirements. Except for the all-cause hospital 
readmission measure, the minimum case requirement is 20 cases. For the 
all-cause hospital readmission measure, the minimum case requirement is 
200 cases.
    (iv) Topped out measures. CMS will identify topped out measures in 
the benchmarks published for each Quality Payment Program year.
    (A) For the 2020 MIPS payment year, each topped out measure 
specified by CMS through rulemaking receives no more than 7 measure 
achievement points, provided that the benchmark for the applicable 
collection type is identified as topped out in the benchmarks published 
for the 2018 MIPS performance period.
    (B) Beginning with the 2021 MIPS payment year, each measure (except 
for measures in the CMS Web Interface) for which the benchmark for the 
applicable collection type is identified as topped out for 2 or more 
consecutive years receives no more than 7 measure achievement points in 
the second consecutive year it is identified as topped out, and beyond.

[[Page 36081]]

    (v) Measure bonus points. MIPS eligible clinicians receive measure 
bonus points for the following measures, except as otherwise required 
under Sec.  414.1335, regardless of whether the measure is included in 
the MIPS eligible clinician's total measure achievement points.
    (A) High priority measures. Subject to paragraph (b)(1)(v)(A)(1) of 
this section, MIPS eligible clinicians receive 2 measure bonus points 
for each outcome and patient experience measure and 1 measure bonus 
point for each other high priority measure. Beginning with the 2021 
MIPS payment year, MIPS eligible clinicians do not receive such measure 
bonus points for CMS Web Interface measures.
    (1) Limitations. (i) Each high priority measure must have a 
benchmark at paragraph (b)(1)(ii) of this section, meet the case 
minimum requirement at (b)(1)(iii) of this section, meet the data 
completeness requirement at Sec.  414.1340, and have a performance rate 
that is greater than zero.
    (ii) For the 2019, 2020, and 2021 MIPS payment years, the total 
measure bonus points for high priority measures cannot exceed 10 
percent of the total available measure achievement points.
    (iii) Beginning with the 2021 MIPS payment year, MIPS eligible 
clinicians that collect data in accordance with Sec.  414.1325 on a 
single measure via multiple collection types receive measure bonus 
points only once.
    (B) End-to-end electronic reporting. Subject to paragraph 
(b)(1)(v)(B)(1) of this section, MIPS eligible clinicians receive 1 
measure bonus point for each measure (except claims-based measures) 
submitted with end-to-end electronic reporting for a quality measure 
under certain criteria determined by the Secretary.
    (1) Limitations. (i) For the 2019, 2020, and 2021 MIPS payment 
years, the total measure bonus points for measures submitted with end-
to-end electronic reporting cannot exceed 10 percent of the total 
available measure achievement points.
    (ii) Beginning with the 2021 MIPS payment year, MIPS eligible 
clinicians that collect data in accordance with Sec.  414.1325 on a 
single measure via multiple collection types receive measure bonus 
points only once.
    (C) Small practices. Beginning with the 2021 MIPS payment year, 
MIPS eligible clinicians in small practices receive 3 measure bonus 
points if they submit data to MIPS on at least 1 quality measure.
    (vi) Improvement scoring. Improvement scoring is available to MIPS 
eligible clinicians that demonstrate improvement in performance in the 
current MIPS performance period compared to performance in the 
performance period immediately prior to the current MIPS performance 
period based on measure achievement points.
    (A) Improvement scoring is available when the data sufficiency 
standard is met, which means when data are available and a MIPS 
eligible clinician has a quality performance category achievement 
percent score for the previous performance period and the current 
performance period.
    (1) Data must be comparable to meet the requirement of data 
sufficiency which means that the quality performance category 
achievement percent score is available for the current performance 
period and the previous performance period and quality performance 
category achievement percent scores can be compared.
    (2) Quality performance category achievement percent scores are 
comparable when submissions are received from the same identifier for 
two consecutive performance periods.
    (3) If the identifier is not the same for 2 consecutive performance 
periods, then for individual submissions, the comparable quality 
performance category achievement percent score is the highest available 
quality performance category achievement percent score associated with 
the final score from the prior performance period that will be used for 
payment for the individual. For group, virtual group, and APM Entity 
submissions, the comparable quality performance category achievement 
percent score is the average of the quality performance category 
achievement percent score associated with the final score from the 
prior performance period that will be used for payment for each of the 
individuals in the group.
    (4) Improvement scoring is not available for clinicians who were 
scored under facility-based measurement in the performance period 
immediately prior to the current MIPS performance period.
    (B) The improvement percent score may not total more than 10 
percentage points.
    (C) The improvement percent score is assessed at the performance 
category level for the quality performance category and included in the 
calculation of the quality performance category percent score as 
described in paragraph (b)(1)(vii) of this section.
    (1) The improvement percent score is awarded based on the rate of 
increase in the quality performance category achievement percent score 
of MIPS eligible clinicians from the previous performance period to the 
current performance period.
    (2) An improvement percent score is calculated by dividing the 
increase in the quality performance category achievement percent score 
from the prior performance period to the current performance period by 
the prior performance period quality performance category achievement 
percent score multiplied by 10 percent.
    (3) An improvement percent score cannot be lower than zero 
percentage points.
    (4) For the 2020 and 2021 MIPS payment year, we will assume a 
quality performance category achievement percent score of 30 percent if 
a MIPS eligible clinician earned a quality performance category score 
less than or equal to 30 percent in the previous year.
    (5) The improvement percent score is zero if the MIPS eligible 
clinician did not fully participate in the quality performance category 
for the current performance period.
    (D) For the purpose of improvement scoring methodology, the term 
``quality performance category achievement percent score'' means the 
total measure achievement points divided by the total available measure 
achievement points, without consideration of measure bonus points or 
improvement percent score.
    (E) For the purpose of improvement scoring methodology, the term 
``improvement percent score'' means the score that represents 
improvement for the purposes of calculating the quality performance 
category percent score as described in paragraph (b)(1)(vii) of this 
section.
    (F) For the purpose of improvement scoring methodology, the term 
``fully participate'' means the MIPS eligible clinician met all 
requirements in Sec. Sec.  414.1335 and 414.1340.
    (vii) Quality performance category score. A MIPS eligible 
clinician's quality performance category percent score is the sum of 
all the measure achievement points assigned for the measures required 
for the quality performance category criteria plus the measure bonus 
points in paragraph (b)(1)(v) of this section. The sum is divided by 
the sum of total available measure achievement points. The improvement 
percent score in paragraph (b)(1)(vi) of this section is added to that 
result. The quality performance category percent score cannot exceed 
100 percentage points.
    (A) Beginning with the 2021 MIPS payment year, for MIPS eligible 
clinicians that submit data on a measure significantly impacted by 
clinical guideline changes or other changes that CMS believes may pose 
patient safety

[[Page 36082]]

concerns, the total available measure achievement points category are 
reduced by 10 points.
    (B) Beginning with the 2021 MIPS payment year, for groups that 
register for the CAHPS for MIPS survey but do not meet the minimum 
beneficiary sampling requirements, the total available measure 
achievement points are reduced by 10 points.
    (viii) ICD-10 updates. Beginning with the 2018 MIPS performance 
period, measures significantly impacted by ICD-10 updates, as 
determined by CMS, will be assessed based only on the first 9 months of 
the 12-month performance period. For purposes of this paragraph 
(b)(1)(viii), CMS will make a determination as to whether a measure is 
significantly impacted by ICD-10 coding changes during the performance 
period. CMS will publish on the CMS website which measures require a 9-
month assessment process by October 1st of the performance period if 
technically feasible, but by no later than the beginning of the data 
submission period at Sec.  414.1325(f)(1).
    (2) Cost performance category. For each cost measure attributed to 
a MIPS eligible clinician, the clinician receives one to ten 
achievement points based on the clinician's performance on the measure 
during the performance period compared to the measure's benchmark. 
Achievement points are awarded based on which benchmark decile range 
the MIPS eligible clinician's performance on the measure is between. 
CMS assigns partial points based on the percentile distribution.
    (i) Cost measure benchmarks are determined by CMS based on cost 
measure performance during the performance period. At least 20 MIPS 
eligible clinicians or groups must meet the minimum case volume 
specified under Sec.  414.1350(c) for a cost measure in order for a 
benchmark to be determined for the measure. If a benchmark is not 
determined for a cost measure, the measure will not be scored.
    (ii) A MIPS eligible clinician must meet the minimum case volume 
specified under Sec.  414.1350(c) to be scored on a cost measure.
    (iii) The cost performance category percent score is the sum of the 
following, not to exceed 100 percent:
    (A) The total number of achievement points earned by the MIPS 
eligible clinician divided by the total number of available achievement 
points; and
    (B) The cost improvement score, as determined under paragraph 
(b)(2)(iv) of this section.
    (iv) The cost improvement score is determined for a MIPS eligible 
clinician that demonstrates improvement in performance in the current 
MIPS performance period compared to their performance in the 
immediately preceding MIPS performance period.
    (A) The cost improvement score is determined at the measure level 
for the cost performance category.
    (B) The cost improvement score is calculated only when data 
sufficient to measure improvement is available. Sufficient data is 
available when a MIPS eligible clinician or group participates in MIPS 
using the same identifier in 2 consecutive performance periods and is 
scored on the same cost measure(s) for 2 consecutive performance 
periods. If the cost improvement score cannot be calculated because 
sufficient data is not available, then the cost improvement score is 
zero.
    (C) The cost improvement score is determined by comparing the 
number of measures with a statistically significant change (improvement 
or decline) in performance; a change is determined to be significant 
based on application of a t-test. The number of cost measures with a 
significant decline is subtracted from the number of cost measures with 
a significant improvement, with the result divided by the number of 
cost measures for which the MIPS eligible clinician or group was scored 
for 2 consecutive performance periods. The resulting fraction is then 
multiplied by the maximum cost improvement score.
    (D) The cost improvement score cannot be lower than zero percentage 
points.
    (E) The maximum cost improvement score for the 2020, 2021, 2022, 
and 2023 MIPS payment years is zero percentage points.
    (v) A cost performance category percent score is not calculated if 
a MIPS eligible clinician or group is not attributed any cost measures 
for the performance period because the clinician or group has not met 
the minimum case volume specified by CMS for any of the cost measures 
or a benchmark has not been created for any of the cost measures that 
would otherwise be attributed to the clinician or group.
    (3) Improvement activities performance category. Subject to 
paragraphs (b)(3)(i) and (ii) of this section, the improvement 
activities performance category score equals the total points for all 
submitted improvement activities divided by 40 points, multiplied by 
100 percent. MIPS eligible clinicians (except for non-patient facing 
MIPS eligible clinicians, small practices, and practices located in 
rural areas and geographic HPSAs) receive 10 points for each medium-
weighted improvement activity and 20 points for each high-weighted 
improvement activity required under Sec.  414.1360 on which data is 
submitted in accordance with Sec.  414.1325. Non-patient facing MIPS 
eligible clinicians, small practices, and practices located in rural 
areas and geographic HPSAs receive 20 points for each medium-weighted 
improvement activity and 40 points for each high-weighted improvement 
activity required under Sec.  414.1360 on which data is submitted in 
accordance with Sec.  414.1325.
    (i) For MIPS eligible clinicians participating in APMs, the 
improvement activities performance category score is at least 50 
percent.
    (ii) For MIPS eligible clinicians in a practice that is certified 
or recognized as a patient-centered medical home or comparable 
specialty practice, as determined by the Secretary, the improvement 
activities performance category score is 100 percent. For the 2019 MIPS 
payment year, at least one practice site within a group's TIN must be 
certified or recognized as a patient-centered medical home or 
comparable specialty practice. For the 2020 MIPS payment year and 
future years, at least 50 percent of the practice sites within a 
group's TIN must be recognized as a patient-centered medical home or 
comparable specialty practice. MIPS eligible clinicians that wish to 
claim this status for purposes of receiving full credit in the 
improvement activities performance category must attest to their status 
as a patient-centered medical home or comparable specialty practice in 
order to receive this credit. A practice is certified or recognized as 
a patient-centered medical home if it meets any of the following 
criteria:
    (A) The practice has received accreditation from one of four 
accreditation organizations that are nationally recognized;
    (1) The Accreditation Association for Ambulatory Health Care;
    (2) The National Committee for Quality Assurance (NCQA);
    (3) The Joint Commission; or
    (4) The Utilization Review Accreditation Commission (URAC).
    (B) The practice is participating in a Medicaid Medical Home Model 
or Medical Home Model.
    (C) The practice is a comparable specialty practice that has 
received the NCQA Patient-Centered Specialty Recognition.
    (D) The practice has received accreditation from other certifying 
bodies that have certified a large number of medical organizations and 
meet national guidelines, as determined by the Secretary. The Secretary 
must

[[Page 36083]]

determine that these certifying bodies must have 500 or more certified 
member practices, and require practices to include the following:
    (1) Have a personal physician/clinician in a team-based practice.
    (2) Have a whole-person orientation.
    (3) Provide coordination or integrated care.
    (4) Focus on quality and safety.
    (5) Provide enhanced access.
    (4) Promoting Interoperability performance category. (i) For the 
2019 and 2020 MIPS payment years, a MIPS eligible clinician's Promoting 
Interoperability performance category score equals the sum of the base 
score, performance score, and any applicable bonus scores, not to 
exceed 100 percentage points. A MIPS eligible clinician cannot earn a 
performance score or bonus score unless they have earned a base score.
    (A) A MIPS eligible clinician earns a base score by reporting for 
each base score measure, as applicable: The numerator (of at least one) 
and denominator, or a yes/no statement, or an exclusion.
    (B) A MIPS eligible clinician earns a performance score by 
reporting on the performance score measures specified by CMS. A MIPS 
eligible clinician may earn up to 10 or 20 percentage points as 
specified by CMS for each performance score measure reported.
    (C) A MIPS eligible clinician may earn the following bonus scores:
    (1) A bonus score of 5 percentage points for reporting to one or 
more additional public health agencies or clinical data registries.
    (2) A bonus score of 10 percentage points for attesting to 
completing one or more improvement activities specified by CMS using 
CEHRT.
    (3) For the 2020 MIPS payment year, a bonus score of 10 percentage 
points for submitting data for the measures for the base score and the 
performance score generated solely from CEHRT as defined in Sec.  
414.1305 for 2019 and subsequent years.
    (ii) For the 2021 MIPS payment year, a MIPS eligible clinician's 
Promoting Interoperability performance category score equals the sum of 
the scores for each of the required 6 measures and any applicable bonus 
scores, not to exceed 100 points.
    (A) A MIPS eligible clinician earns a score for each measure by 
reporting, as applicable: The numerator (of at least one) and 
denominator, or a yes/no statement, or an exclusion.
    (B) A MIPS eligible clinician may earn a bonus score of 5 points 
each for two optional measures.
    (iii) Beginning with the 2022 MIPS payment year, a MIPS eligible 
clinician's Promoting Interoperability performance category score 
equals the sum of the scores for each of the required 8 measures, not 
to exceed 100 points.
    (A) A MIPS eligible clinician earns a score for each measure by 
reporting, as applicable: The numerator (of at least one) and 
denominator, or a yes/no statement, or an exclusion.
    (B) [Reserved]
    (c) Final score calculation. Each MIPS eligible clinician receives 
a final score of 0 to 100 points for a performance period for a MIPS 
payment year calculated as follows. If a MIPS eligible clinician is 
scored on fewer than 2 performance categories, he or she receives a 
final score equal to the performance threshold.

------------------------------------------------------------------------
 
-------------------------------------------------------------------------
For the 2019 MIPS payment year:
    Final score = [(quality performance category percent score x quality
     performance category weight) + (cost performance category percent
     score x cost performance category weight)+ (improvement activities
     performance category score x improvement activities performance
     category weight) + (Promoting Interoperability performance category
     score x Promoting Interoperability performance category weight)],
     not to exceed 100 points.
For the 2020 MIPS payment year:
    Final score = [(quality performance category percent score x quality
     performance category weight) + (cost performance category percent
     score x cost performance category weight) + (improvement activities
     performance category score x improvement activities performance
     category weight) + (Promoting Interoperability performance category
     score x Promoting Interoperability performance category weight)] x
     100 + [the complex patient bonus + the small practice bonus], not
     to exceed 100 points.
Beginning with the 2021 MIPS payment year:
    Final score = [(quality performance category percent score x quality
     performance category weight) + (cost performance category percent
     score x cost performance category weight) + (improvement activities
     performance category score x improvement activities performance
     category weight) + (Promoting Interoperability performance category
     score x Promoting Interoperability performance category weight)] x
     100 + the complex patient bonus, not to exceed 100 points.
------------------------------------------------------------------------

    (1) Performance category weights. The weights of the performance 
categories in the final score are as follows, unless a different 
scoring weight is assigned under paragraph (c)(2) of this section:
    (i) Quality performance category weight is defined under Sec.  
414.1330(b).
    (ii) Cost performance category weight is defined under Sec.  
414.1350(d).
    (iii) Improvement activities performance category weight is defined 
under Sec.  414.1355(b).
    (iv) Promoting Interoperability performance category weight is 
defined under Sec.  414.1375(a).
    (2) Reweighting the performance categories. (i) In accordance with 
paragraph (c)(2)(ii) of this section, a scoring weight different from 
the weights specified in paragraph (c)(1) of this section will be 
assigned to a performance category, and its weight as specified in 
paragraph (c)(1) of this section will be redistributed to another 
performance category or categories, in the following circumstances:
    (A) CMS determines based on the following circumstances that there 
are not sufficient measures and activities applicable and available 
under section 1848(q)(5)(F) of the Act.
    (1) For the quality performance category, CMS cannot calculate a 
score for the MIPS eligible clinician because there is not at least one 
quality measure applicable and available to the clinician.
    (2) For the cost performance category, CMS cannot reliably 
calculate a score for the cost measures that adequately captures and 
reflects the performance of the MIPS eligible clinician.
    (3) Beginning with the 2021 MIPS payment year, for the quality, 
cost, improvement activities, and Promoting Interoperability 
performance categories, the MIPS eligible clinician joins an existing 
practice during the final 3 months of the performance period year that 
is not participating in MIPS as a group or joins a practice that is 
newly formed during the final 3 months of the performance period year.
    (4) For the Promoting Interoperability performance category 
beginning with the 2021 MIPS payment year, the MIPS eligible clinician 
is a physical therapist, occupational therapist, clinical social 
worker, or clinical psychologist. In the event that a MIPS eligible 
clinician submits data for the Promoting Interoperability performance 
category, the scoring weight specified in

[[Page 36084]]

paragraph (c)(1) of this section will be applied and its weight will 
not be redistributed.
    (5) For the Promoting Interoperability performance category for the 
2019, 2020, and 2021 MIPS payment years, the MIPS eligible clinician is 
a nurse practitioner, physician assistant, clinical nurse specialist, 
or certified registered nurse anesthetist. In the event that a MIPS 
eligible clinician submits data for the Promoting Interoperability 
performance category, the scoring weight specified in paragraph (c)(1) 
of this section will be applied and its weight will not be 
redistributed.
    (6) Beginning with the 2020 MIPS payment year, for the quality, 
cost, and improvement activities performance categories, the MIPS 
eligible clinician demonstrates through an application submitted to CMS 
that they were subject to extreme and uncontrollable circumstances that 
prevented the clinician from collecting information that the clinician 
would submit for a performance category or submitting information that 
would be used to score a performance category for an extended period of 
time. Beginning with the 2021 MIPS payment year, in the event that a 
MIPS eligible clinician submits data for the quality, cost, or 
improvement activities performance categories, the scoring weight 
specified in paragraph (c)(1) of this section will be applied and its 
weight will not be redistributed.
    (7) For the 2019 MIPS payment year, for the quality and improvement 
activities performance categories, the MIPS eligible clinician was 
located in an area affected by extreme and uncontrollable circumstances 
as identified by CMS. In the event that a MIPS eligible clinician 
submits data for a performance category, the scoring weight specified 
in paragraph (c)(1) of this section will be applied and its weight will 
not be redistributed.
    (8) Beginning with the 2020 MIPS payment year, for the quality, 
cost, and improvement activities performance categories, the MIPS 
eligible clinician was located in an area affected by extreme and 
uncontrollable circumstances as identified by CMS. In the event that a 
MIPS eligible clinician submits data for the quality or improvement 
activities performance categories, the scoring weight specified in 
paragraph (c)(1) of this section will be applied and its weight will 
not be redistributed.
    (B) Under section 1848(q)(5)(E)(ii) of the Act, CMS estimates that 
the proportion of MIPS eligible clinicians who are physicians as 
defined in section 1861(r) of the Act and earn a Promoting 
Interoperability performance category score of at least 75 percent is 
75 percent or greater. The estimation is based on data from the 
performance period that occurs four years before the MIPS payment year 
and does not include physicians for whom the Promoting Interoperability 
performance category is weighted at zero percent.
    (C) Under section 1848(o)(2)(D) of the Act, a significant hardship 
exception or other type of exception is granted to a MIPS eligible 
clinician based on the following circumstances for the Promoting 
Interoperability performance category. In the event that a MIPS 
eligible clinician submits data for the Promoting Interoperability 
performance category, the scoring weight specified in paragraph (c)(1) 
of this section will be applied and its weight will not be 
redistributed.
    (1) The MIPS eligible clinician demonstrates through an application 
submitted to CMS that they lacked sufficient internet access during the 
performance period, and insurmountable barriers prevented the clinician 
from obtaining sufficient internet access.
    (2) The MIPS eligible clinician demonstrates through an application 
submitted to CMS that they were subject to extreme and uncontrollable 
circumstances that caused their CEHRT to be unavailable.
    (3) The MIPS eligible clinician was located in an area affected by 
extreme and uncontrollable circumstances as identified by CMS.
    (4) The MIPS eligible clinician demonstrates through an application 
submitted to CMS that 50 percent or more of their outpatient encounters 
occurred in practice locations where they had no control over the 
availability of CEHRT.
    (5) The MIPS eligible clinician is a non-patient facing MIPS 
eligible clinician as defined in Sec.  414.1305.
    (6) The MIPS eligible clinician is a hospital-based MIPS eligible 
clinician as defined in Sec.  414.1305.
    (7) The MIPS eligible clinician is an ASC-based MIPS eligible 
clinician as defined in Sec.  414.1305.
    (8) Beginning with the 2020 MIPS payment year, the MIPS eligible 
clinician demonstrates through an application submitted to CMS that 
their CEHRT was decertified either during the performance period for 
the MIPS payment year or during the calendar year preceding the 
performance period for the MIPS payment year, and the MIPS eligible 
clinician made a good faith effort to adopt and implement another CEHRT 
in advance of the performance period. In no case may a MIPS eligible 
clinician be granted this exception for more than 5 years.
    (9) Beginning with the 2020 MIPS payment year, the MIPS eligible 
clinician demonstrates through an application submitted to CMS that 
they are in a small practice as defined in Sec.  414.1305, and 
overwhelming barriers prevent them from complying with the requirements 
for the Promoting Interoperability performance category.
    (ii) A scoring weight different from the weights specified in 
paragraph (c)(1) of this section will be assigned to a performance 
category, and its weight as specified in paragraph (c)(1) of this 
section will be redistributed to another performance category or 
categories, as follows:
    (A) For the 2019 MIPS payment year:

----------------------------------------------------------------------------------------------------------------
                                                                    Reweight         Reweight        Reweight
                                                                 scenario if no   scenario if no  scenario if no
                                                 Weighting for      promoting         quality       improvement
             Performance category                the 2019 MIPS  interoperability    performance     activities
                                                 payment year      performance       category       performance
                                                      (%)        category score    percent score  category score
                                                                       (%)              (%)             (%)
----------------------------------------------------------------------------------------------------------------
Quality.......................................              60               85                0              75
Cost..........................................               0                0                0               0
Improvement Activities........................              15               15               50               0
Promoting Interoperability....................              25                0               50              25
----------------------------------------------------------------------------------------------------------------

    (B) For the 2020 MIPS payment year:

[[Page 36085]]



----------------------------------------------------------------------------------------------------------------
                                                                                                    Promoting
             Reweighting scenario                 Quality (%)      Cost (%)       Improvement   interoperability
                                                                                activities (%)         (%)
----------------------------------------------------------------------------------------------------------------
No Reweighting Needed:
    --Scores for all four performance                       50              10              15               25
     categories...............................
Reweight One Performance Category:
    --No Cost.................................              60               0              15               25
    --No Promoting Interoperability...........              75              10              15                0
    --No Quality..............................               0              10              45               45
    --No Improvement Activities...............              65              10               0               25
Reweight Two Performance Categories:
    --No Cost and no Promoting                              85               0              15                0
     Interoperability.........................
    --No Cost and no Quality..................               0               0              50               50
    --No Cost and no Improvement Activities...              75               0               0               25
    --No Promoting Interoperability and no                   0              10              90                0
     Quality..................................
    --No Promoting Interoperability and no                  90              10               0                0
     Improvement Activities...................
    --No Quality and no Improvement Activities               0              10               0               90
----------------------------------------------------------------------------------------------------------------

    (C) For the 2021 MIPS payment year:

----------------------------------------------------------------------------------------------------------------
                                                                                                    Promoting
             Reweighting scenario                 Quality (%)      Cost (%)       Improvement   interoperability
                                                                                activities (%)         (%)
----------------------------------------------------------------------------------------------------------------
No Reweighting Needed:
    --Scores for all four performance                       45              15              15               25
     categories...............................
Reweight One Performance Category:
    --No Cost.................................              60               0              15               25
    --No Promoting Interoperability...........              70              15              15                0
    --No Quality..............................               0              15              40               45
    --No Improvement Activities...............              60              15               0               25
Reweight Two Performance Categories:
    --No Cost and no Promoting                              85               0              15                0
     Interoperability.........................
    --No Cost and no Quality..................               0               0              50               50
    --No Cost and no Improvement Activities...              75               0               0               25
    --No Promoting Interoperability and no                   0              15              85                0
     Quality..................................
    --No Promoting Interoperability and no                  85              15               0                0
     Improvement Activities...................
    --No Quality and no Improvement Activities               0              15               0               85
----------------------------------------------------------------------------------------------------------------

    (iii) For MIPS eligible clinicians submitting data as a group or 
virtual group, in order for the Promoting Interoperability performance 
category to be reweighted in accordance with paragraph (c)(2)(ii) of 
this section, all of the MIPS eligible clinicians in the group must 
qualify for reweighting based on the circumstances described in 
paragraph (c)(2)(i) of this section.
    (3) Complex patient bonus. For the 2020 and 2021 MIPS payment 
years, provided that a MIPS eligible clinician, group, virtual group or 
APM entity submits data for at least one MIPS performance category for 
the applicable performance period for the MIPS payment year, a complex 
patient bonus will be added to the final score for the MIPS payment 
year, as follows:
    (i) For MIPS eligible clinicians and groups, the complex patient 
bonus is calculated as follows: [The average HCC risk score assigned to 
beneficiaries (pursuant to the HCC risk adjustment model established by 
CMS pursuant to section 1853(a)(1) of the Act) seen by the MIPS 
eligible clinician or seen by clinicians in a group] + [the dual 
eligible ratio x 5].
    (ii) For APM entities and virtual groups, the complex patient bonus 
is calculated as follows: [The beneficiary weighted average HCC risk 
score for all MIPS eligible clinicians, and if technically feasible, 
TINs for models and virtual groups which rely on complete TIN 
participation within the APM entity or virtual group, respectively] + 
[the average dual eligible ratio for all MIPS eligible clinicians, and 
if technically feasible, TINs for models and virtual groups which rely 
on complete TIN participation, within the APM entity or virtual group, 
respectively, x 5].
    (iii) The complex patient bonus cannot exceed 5.0.
    (4) Small practice bonus. A small practice bonus of 5 points will 
be added to the final score for the 2020 MIPS payment year for MIPS 
eligible clinicians, groups, virtual groups, and APM Entities that meet 
the definition of a small practice as defined at Sec.  414.1305 and 
participate in MIPS by submitting data on at least one performance 
category in the 2018 MIPS performance period.
    (d) Scoring for APM Entities. MIPS eligible clinicians in APM 
Entities that are subject to the APM scoring standard are scored using 
the methodology under Sec.  414.1370.
    (e) Scoring for facility-based measurement. For the payment in 2021 
MIPS payment year and subsequent years and subject to paragraph 
(e)(6)(vi) of this section, a MIPS eligible clinician or group may be 
scored under the quality and cost performance categories using 
facility-based measures under the methodology described in this 
paragraph (e).
    (1) General. The facility-based measurement scoring standard is the 
MIPS scoring methodology applicable for MIPS eligible clinicians 
identified as meeting the requirements in paragraph (e)(2) of this 
section.
    (i) The measures for facility-based measurement consist of the 
measure set finalized for the fiscal year VBP program for which payment 
begins during the applicable MIPS performance period.
    (ii) Beginning with the 2021 MIPS payment year, the scoring 
methodology

[[Page 36086]]

applicable for MIPS eligible clinicians scored with facility-based 
measurement is the Total Performance Score methodology adopted for the 
Hospital VBP Program, for the fiscal year for which payment begins 
during the applicable MIPS performance period.
    (2) Eligibility for facility-based measurement. MIPS eligible 
clinicians are eligible for facility-based measurement for a MIPS 
payment year if they are determined to be facility-based as an 
individual clinician or as part of a group, as follows:
    (i) Facility-based individual determination. A MIPS eligible 
clinician is facility-based if the clinician meets all of the following 
criteria:
    (A) Furnishes 75 percent or more of his or her covered professional 
services in sites of service identified by the place of service codes 
used in the HIPAA standard transaction as an inpatient hospital, on-
campus outpatient hospital, or emergency room setting based on claims 
for a 12-month segment beginning on October 1 of the calendar year 2 
years prior to the applicable performance period and ending on 
September 30 of the calendar year preceding the performance period with 
a 30-day claims run out.
    (B) Furnishes at least 1 covered professional service in sites of 
service identified by the place of service codes used in the HIPAA 
standard transaction as an inpatient hospital, or emergency room 
setting.
    (C) Can be attributed, under the methodology specified in paragraph 
(e)(5) of this section, to a facility with a VBP score for the 
applicable period.
    (ii) Facility-based group determination. A facility-based group is 
a group in which 75 percent or more of its eligible clinician NPIs 
billing under the group's TIN meet the requirements under paragraph 
(e)(2)(i) of this section.
    (3) [Reserved]
    (4) Data submission for facility-based measurement. There are no 
data submission requirements for individual clinicians scored under 
facility-based measurement. A group must submit data in the improvement 
activities or Promoting Interoperability performance categories in 
order to be scored as a facility-based group.
    (5) Determination of applicable facility score. (i) A facility-
based clinician is scored with facility-based measurement using the 
score derived from the value-based purchasing score for the facility at 
which the clinician provided services to the most Medicare 
beneficiaries during the year the claims are drawn from in paragraph 
(e)(2) of this section. If there is an equal number of Medicare 
beneficiaries treated at more than one facility, the value-based 
purchasing score for the highest scoring facility is used.
    (ii) A facility-based group is scored with facility-based 
measurement using the score derived from the value-based purchasing 
score for the facility at which the plurality of clinicians identified 
as facility-based would have had their score determined under paragraph 
(e)(5)(i) of this section.
    (6) MIPS performance category scoring under the facility-based 
measurement scoring standard--(i) Measures. The quality and cost 
measures are those adopted under the value-based purchasing program of 
the facility for the year described in paragraph (e)(1)(i) of this 
section.
    (ii) Benchmarks. The benchmarks are those adopted under the value-
based purchasing program of the facility program for the year described 
in paragraph (e)(1)(i) of this section.
    (iii) Performance period. The performance period for facility-based 
measurement is the performance period for the measures adopted under 
the value-based purchasing program of the facility program for the year 
described in paragraph (e)(1)(i) of this section.
    (iv) Quality. The quality performance category percent score is 
established by determining the percentile performance of the facility 
in the value-based purchasing program for the specified year as 
described in paragraph (e)(1)(i) of this section and awarding a score 
associated with that same percentile performance in the MIPS quality 
performance category percent score for those MIPS-eligible clinicians 
who are not eligible to be scored using facility-based measurement for 
the MIPS payment year. This score will not include a consideration of 
improvement in the MIPS quality performance category score.
    (v) Cost. The cost performance category percent score is 
established by determining the percentile performance of the facility 
in the value-based purchasing program for the specified year as 
described in paragraph (e)(1)(i) of this section and awarding a score 
associated with that same percentile performance in the MIPS cost 
performance category percent score for those MIPS eligible clinicians 
who are not eligible to be scored using facility-based measurement for 
the MIPS payment year. This score will not include a consideration of 
improvement in cost measures.
    (A) Other cost measures. MIPS eligible clinicians who are scored 
under facility-based measurement are not scored on cost measures 
described in paragraph (b)(2) of this section.
    (B) [Reserved]
    (vi) Use of score from facility-based measurement. The MIPS quality 
and cost performance category scores will be based on the facility-
based measurement scoring methodology described in paragraph (e)(6) of 
this section unless a clinician or group receive a higher combined MIPS 
quality and cost performance category scores through another MIPS 
submission.
0
36. Section 414.1395 is amended by revising paragraphs (b) and (c) to 
read as follows:


Sec.  414.1395  Public reporting.

* * * * *
    (b) Maintain existing public reporting standards. With the 
exception of data that must be mandatorily reported on Physician 
Compare, for each program year, CMS relies on established public 
reporting standards to guide the information available for inclusion on 
Physician Compare. The public reporting standards require data included 
on Physician Compare to be statistically valid, reliable, and accurate; 
comparable across collection types; and meet the reliability threshold. 
And, to be included on the public facing profile pages, the data must 
also resonate with website users, as determined by CMS.
    (c) First year measures. For each program year, CMS does not 
publicly report any first year measure for the first 2 years, meaning 
any measure in its first 2 years of use in the quality and cost 
performance categories. After the first 2 years, CMS reevaluates 
measures to determine when and if they are suitable for public 
reporting.
* * * * *
0
37. Section 414.1400 is revised to read as follows:


Sec.  414.1400  Third party intermediaries.

    (a) General. (1) MIPS data may be submitted on behalf of a MIPS 
eligible clinician, group, or virtual group by any of the following 
third party intermediaries:
    (i) A QCDR;
    (ii) A qualified registry;
    (iii) A health IT vendor; or
    (iv) A CMS-approved survey vendor.
    (2) QCDRs, qualified registries, and health IT vendors may submit 
MIPS data for any of the following MIPS performance categories:
    (i) Quality, except for data on the CAHPS for MIPS survey;
    (ii) Improvement activities; or
    (iii) Promoting Interoperability, if the MIPS eligible clinician, 
group, or virtual group is using CEHRT.
    (3) CMS-approved survey vendors may submit data on the CAHPS for 
MIPS survey for the MIPS quality performance category.

[[Page 36087]]

    (4) To be approved as a third party intermediary, an entity must 
agree to meet the applicable requirements of this section, including, 
but not limited to, the following:
    (i) A third party intermediary's principle place of business and 
retention of any data must be based in the U.S.
    (ii) If the data is derived from CEHRT, a QCDR, qualified registry, 
or health IT vendor must be able to indicate its data source.
    (iii) All data must be submitted in the form and manner specified 
by CMS.
    (5) All data submitted to CMS by a third party intermediary on 
behalf of a MIPS eligible clinician, group or virtual group must be 
certified by the third party intermediary as true, accurate, and 
complete to the best of its knowledge. Such certification must be made 
in a form and manner and at such time as specified by CMS.
    (b) QCDR approval criteria--(1) QCDR self-nomination. For the 2020 
and 2021 MIPS payment years, entities seeking to qualify as a QCDR must 
self-nominate September 1 until November 1 of the CY preceding the 
applicable performance period. For the 2022 MIPS payment year and 
future years, entities seeking to qualify as a QCDR must self-nominate 
during a 60-day period during the CY preceding the applicable 
performance period (beginning no earlier than July 1 and ending no 
later than September 1). Entities seeking to qualify as a QCDR for a 
performance period must provide all information required by CMS at the 
time of self-nomination and must provide any additional information 
requested by CMS during the review process. For the 2021 MIPS payment 
year and future years, existing QCDRs that are in good standing may 
attest that certain aspects of their previous year's approved self-
nomination have not changed and will be used for the applicable 
performance period.
    (2) Establishment of a QCDR entity. (i) Beginning with the 2022 
MIPS Payment Year, the QCDR must have at least 25 participants by 
January 1 of the year prior to the applicable performance period.
    (ii) If the entity uses an external organization for purposes of 
data collection, calculation, or transmission, it must have a signed, 
written agreement with the external organization that specifically 
details the responsibilities of the entity and the external 
organization. The written agreement must be effective as of September 1 
of the year preceding the applicable performance period.
    (3) QCDR measures for the quality performance category. (i) For 
purposes of QCDRs submitting data for the MIPS quality performance 
category, CMS considers the following types of quality measures to be 
QCDR measures:
    (A) Measures that are not included in the MIPS final list of 
quality measures described in Sec.  414.1330(a)(1) for the applicable 
MIPS payment year; and
    (B) Measures that are included in the MIPS final list of quality 
measures described in Sec.  414.1330(a)(1) for the applicable MIPS 
payment year, but have undergone substantive changes, as determined by 
CMS.
    (ii) For the 2020 MIPS payment year and future years, an entity 
seeking to become a QCDR must submit specifications for each measure, 
activity, and objective that the entity intends to submit to for MIPS 
(including the information described in paragraphs (b)(3)(ii)(A) and 
(B) of this section) at the time of self-nomination. In addition, no 
later than 15 calendar days following CMS approval of any QCDR measure 
specifications, the entity must publicly post the measure 
specifications for each QCDR measure (including the CMS-assigned QCDR 
measure ID) and provide CMS with a link to where this information is 
posted.
    (A) For QCDR measures, the entity must submit the measure 
specifications for each QCDR measure, including: Name/title of 
measures, NQF number (if NQF-endorsed), descriptions of the 
denominator, numerator, and when applicable, denominator exceptions, 
denominator exclusions, risk adjustment variables, and risk adjustment 
algorithms.
    (B) For MIPS quality measures, the entity must submit the MIPS 
measure IDs and specialty-specific measure sets, as applicable.
    (C) Beginning with the 2021 MIPS payment year, as a condition of a 
QCDR measure's approval for purposes of MIPS, the QCDR measure owner 
would be required to agree to enter into a license agreement with CMS 
permitting any approved QCDR to submit data on the QCDR measure 
(without modification) for purposes of MIPS and each applicable MIPS 
payment year.
    (iii) A QCDR must include the CMS-assigned QCDR measure ID when 
submitting data on any QCDR measure to CMS.
    (c) Qualified registry approval criteria--(1) Qualified registry 
self-nomination. For the 2020 and 2021 MIPS payment years, entities 
seeking to qualify as a qualified registry must self-nominate from 
September 1 until November 1 of the CY preceding the applicable 
performance period. For the 2022 MIPS payment year and future years, 
entities seeking to qualify as a qualified registry must self-nominate 
during a 60-day period during the CY preceding the applicable 
performance period (beginning no earlier than July 1 and ending no 
later than September 1). Entities seeking to qualify as a qualified 
registry for a performance period must provide all information required 
by CMS at the time of self-nomination and must provide any additional 
information requested by CMS during the review process. For the 2021 
MIPS payment year and future years, existing qualified registries that 
are in good standing may attest that certain aspects of their previous 
year's approved self-nomination have not changed and will be used for 
the applicable performance period.
    (2) Establishment of a qualified registry entity. Beginning with 
the 2022 MIPS Payment Year, the qualified registry must have at least 
25 participants by January 1 of the year prior to the applicable 
performance period.
    (d) Health IT vendor approval criteria. Health IT vendors must meet 
the criteria specified at Sec.  414.1400(a)(4).
    (e) CMS-approved survey vendor approval criteria. Entities seeking 
to be a CMS-approved survey vendor for any MIPS performance period must 
submit a survey vendor application to CMS in a form and manner 
specified by CMS for each MIPS performance period for which it wishes 
to transmit such data. The application and any supplemental information 
requested by CMS must be submitted by deadlines specified by CMS. For 
an entity to be a CMS-approved survey vendor, it must meet the 
following criteria:
    (1) The entity must have sufficient experience, capability, and 
capacity to accurately report CAHPS data, including:
    (i) At least 3 years of experience administering mixed-mode surveys 
(that is, surveys that employ multiple modes to collect date), 
including mail survey administration followed by survey administration 
via Computer Assisted Telephone Interview (CATI);
    (ii) At least 3 years of experience administering surveys to a 
Medicare population;
    (iii) At least 3 years of experience administering CAHPS surveys 
within the past 5 years;
    (iv) Experience administering surveys in English and one of the 
following languages: Cantonese, Korean, Mandarin, Russian, or 
Vietnamese;
    (v) Use equipment, software, computer programs, systems, and 
facilities that can verify addresses and phone numbers of sampled 
beneficiaries, monitor interviewers,

[[Page 36088]]

collect data via CATI, electronically administer the survey and 
schedule call-backs to beneficiaries at varying times of the day and 
week, track fielded surveys, assign final disposition codes to reflect 
the outcome of data collection of each sampled case, and track cases 
from mail surveys through telephone follow-up activities; and
    (vi) Employ a program manager, information systems specialist, call 
center supervisor and mail center supervisor to administer the survey.
    (2) The entity has certified that it has the ability to maintain 
and transmit quality data in a manner that preserves the security and 
integrity of the data.
    (3) The entity has successfully completed, and has required its 
subcontractors to successfully complete, vendor training(s) 
administered by CMS or its contractors.
    (4) The entity has submitted a quality assurance plan and other 
materials relevant to survey administration, as determined by CMS, 
including cover letters, questionnaires and telephone scripts.
    (5) The entity has agreed to participate and cooperate, and has 
required its subcontractors to participate and cooperate, in all 
oversight activities related to survey administration conducted by CMS 
or its contractors.
    (6) The entity has sent an interim survey data file to CMS that 
establishes the entity's ability to accurately report CAHPS data.
    (f) Remedial action and termination of third party intermediaries. 
(1) If CMS determines that a third party intermediary (that is, a QCDR, 
health IT vendor, qualified registry, or CMS approved survey vendor) 
has ceased to meet one or more of the applicable criteria for approval, 
or has submitted data that is inaccurate, unusable, or otherwise 
compromised, CMS may take one or more of the following remedial actions 
after providing written notice to the third party intermediary:
    (i) Require the third party intermediary to submit a corrective 
action plan (CAP) to CMS to address the identified deficiencies or data 
issue, including the actions it will take to prevent the deficiencies 
or data issues from recurring. The CAP must be submitted to CMS by a 
date specified by CMS.
    (ii) If the third party intermediary has a data error rate of 3 
percent or more, publicly disclose the entity's data error rate on the 
CMS website until the data error rate falls below 3 percent.
    (2) CMS may immediately or with advance notice terminate the 
ability of a third party intermediary to submit MIPS data on behalf of 
a MIPS eligible clinician, group, or virtual group for one or more of 
the following reasons:
    (i) CMS has grounds to impose remedial action;
    (ii) CMS has not received a CAP within the specified time period or 
the CAP is not accepted by CMS; and
    (iii) The third party intermediary fails to correct the 
deficiencies or data errors by the date specified by CMS.
    (3) For purposes of paragraph (e) of this section, CMS may 
determine that submitted data is inaccurate, unusable, or otherwise 
compromised if the submitted data:
    (i) Includes, without limitation, TIN/NPI mismatches, formatting 
issues, calculation errors, or data audit discrepancies; and
    (ii) Affects more than three percent (but less than five percent) 
of the total number of MIPS eligible clinicians or group for which data 
was submitted by the third party intermediary.
0
38. Section 414.1405 is amended by--
0
a. Adding paragraphs (b)(6) and (d)(5);
0
b. Revising paragraph (e) and;
0
c. Adding paragraphs (f) and (g).
    The additions and revision read as follows:


Sec.  414.1405  Payment.

* * * * *
    (b) * * *
    (6) The performance threshold for the 2021 MIPS payment year is 30 
points.
* * * * *
    (d) * * *
    (5) The additional performance threshold for the 2021 MIPS payment 
year is 80 points.
    (e) Application of adjustments to payments. Except as specified in 
paragraph (f) of this section, in the case of covered professional 
services (as defined in section 1848(k)(3)(A) of the Act) furnished by 
a MIPS eligible clinician during a MIPS payment year beginning with 
2019, the amount otherwise paid under Part B with respect to such 
covered professional services and MIPS eligible clinician for such 
year, is multiplied by 1, plus the sum of the MIPS payment adjustment 
factor divided by 100, and as applicable, the additional MIPS payment 
adjustment factor divided by 100.
    (f) Exception to application of MIPS payment adjustment factors to 
model-specific payments under Section 1115A APMs. The payment 
adjustment factors specified under paragraph (e) of this section are 
not applicable to payments:
    (1) Made only to participants in a model tested under section 1115A 
of the Act;
    (2) That would otherwise be subject to the requirement to apply the 
MIPS payment adjustment factors if the payment is made with respect to 
a MIPS eligible clinician to participating in a section 1115A model; 
and
    (3) Are model-specific payments that have a specified payment 
amount; or use a methodology for calculating a model-specific payment 
that is paid in a consistent manner to participants to which 
application of the MIPS payment adjustment factors would potentially 
interfere with CMS's ability to effectively evaluate the impact of the 
APM.
0
39. Section 414.1415 is amended by revising paragraphs (a)(1)(i), 
(b)(1) through (3), (c) introductory text, (c)(3)(i)(A), and (c)(6) to 
read as follows:


Sec.  414.1415  Advanced APM criteria.

    (a) * * *
    (1) * * *
    (i) Require at least 50 percent, or for QP Performance Periods 
beginning in 2019, 75 percent of eligible clinicians in each 
participating APM Entity group, or for APMs in which hospitals are the 
APM Entities, each hospital, to use CEHRT to document and communicate 
clinical care to their patients or health care providers; or
* * * * *
    (b) * * *
    (1) To be an Advanced APM, an APM must include quality measure 
performance as a factor when determining payment to participants for 
covered professional services under the terms of the APM.
    (2) At least one of the quality measures used in the payment 
arrangement as specified in paragraph (c)(1) of this section must:
    (i) For QP Performance Periods before January 1, 2020, have an 
evidence-based focus, be reliable and valid, and meet at least one of 
the following criteria:
    (A) Used in the MIPS quality performance category, as described in 
Sec.  414.1330;
    (B) Endorsed by a consensus-based entity;
    (C) Developed under section 1848(s) of the Act;
    (D) Submitted in response to the MIPS Call for Quality Measures 
under section 1848(q)(2)(D)(ii) of the Act; or
    (E) Any other quality measures that CMS determines to have an 
evidence-based focus and to be reliable and valid; and
    (ii) For QP Performance Periods beginning on or after January 1, 
2020, be:
    (A) Finalized on the MIPS final list of measures, as described in 
Sec.  414.1330;
    (B) Endorsed by a consensus-based entity; or
    (C) Determined by CMS to be evidenced-based, reliable, and valid.

[[Page 36089]]

    (3) In addition to the quality measure described under paragraph 
(b)(2) of this section, the quality measures upon which an Advanced APM 
bases the payment in paragraph (b)(1) of this section must include at 
least one additional measure that is an outcome measure unless CMS 
determines that there are no available or applicable outcome measures 
included in the MIPS final quality measures list for the Advanced APM's 
first QP Performance Period. Beginning January 1, 2020, the included 
outcome measure must satisfy the criteria in paragraph (b)(2) of this 
section.
    (c) Financial risk. To be an Advanced APM, except as described in 
paragraph (c)(6) of this section, an APM must either meet the financial 
risk standard under paragraph (c)(1) or (2) of this section and the 
nominal amount standard under paragraph (c)(3) or (4) of this section 
or be an expanded Medical Home Model under section 1115A(c) of the Act.
* * * * *
    (3) * * *
    (i) * * *
    (A) For QP Performance Periods beginning in 2017, through 2024, 8 
percent of the average estimated total Medicare Parts A and B revenue 
of all providers and suppliers in participating APM Entities; or
* * * * *
    (6) Capitation. A full capitation arrangement meets this Advanced 
APM criterion. For purposes of this part, a full capitation arrangement 
means a payment arrangement in which a per capita or otherwise 
predetermined payment is made under the APM for all items and services 
furnished to a population of beneficiaries during a fixed period of 
time, and no settlement is performed to reconcile or share losses 
incurred or savings earned by the APM Entity. Arrangements between CMS 
and Medicare Advantage Organizations under the Medicare Advantage 
program (42 U.S.C. 422) are not considered capitation arrangements for 
purposes of this paragraph (c)(6).
* * * * *
0
40. Section 414.1420 is amended by revising paragraphs (b), (c)(2) and 
(3), (d) introductory text, (d)(3)(i), and (d)(7) to read as follows:


Sec.  414.1420  Other payer advanced APM criteria.

* * * * *
    (b) Use of CEHRT. To be an Other Payer Advanced APM, CEHRT must be 
used by at least 50 percent, or for QP Performance Periods on or after 
January 1, 2020, 75 percent of participants in each participating APM 
Entity group, or each hospital if hospitals are the APM Entities, in 
the other payer arrangement to document and communicate clinical care.
    (c) * * *
    (2) At least one of the quality measures used in the payment 
arrangement as specified in paragraph (c)(1) of this section must:
    (i) For QP Performance Period before January 1, 2020, have an 
evidence-based focus, be reliable and valid, and meet at least one of 
the following criteria:
    (A) Used in the MIPS quality performance category, as described in 
Sec.  414.1330;
    (B) Endorsed by a consensus-based entity;
    (C) Developed under section 1848(s) of the Act;
    (D) Submitted in response to the MIPS Call for Quality Measures 
under section 1848(q)(2)(D)(ii) of the Act; or
    (E) Any other quality measures that CMS determines to have an 
evidence-based focus and to be reliable and valid; and
    (ii) For QP Performance Periods beginning on or after January 1, 
2020, be:
    (A) Finalized on the MIPS final list of measures, as described in 
Sec.  414.1330;
    (B) Endorsed by a consensus-based entity; or
    (C) Determined by CMS to be evidenced-based, reliable, and valid.
    (3) To meet the quality measure use criterion under paragraph 
(c)(1) of this section, a payment arrangement must:
    (i) For QP Performance Periods before January 1, 2020, use an 
outcome measure if there is an applicable outcome measure on the MIPS 
quality measure list. This criterion also applies for payment 
arrangements determined to be Other Payer Advanced APMs on or before 
January 1, 2020, but only for the Other Payer Advanced APM 
determination made with respect to the arrangement for the CY 2020 QP 
Performance Period (regardless of whether that determination is a 
single- or multi-year determination).
    (ii) For QP Performance Periods on or after January 1, 2020, in 
addition to the quality measure described under paragraph (c)(2) of 
this section, use at least one additional measure that is an outcome 
measure and meets the criteria in paragraph (c)(2)(ii) of this section 
if there is such an applicable outcome measure on the MIPS quality 
measure list.
    (d) Financial risk. To be an Other Payer Advanced APM, except as 
described in paragraph (d)(7) of this section, a payment arrangement 
must meet either the financial risk standard under paragraph (d)(1) or 
(2) of this section and the nominal amount standard under paragraph 
(d)(3) or (4) of this section, or be a Medicaid Medical Home Model with 
criteria comparable to an expanded Medical Home Model under section 
1115A(c) of the Act.
* * * * *
    (3) * * *
    (i) For QP Performance Periods 2019 through 2024, 8 percent of the 
total combined revenues from the payer to providers and other entities 
under the payment arrangement if financial risk is expressly defined in 
terms of revenue; or, 3 percent of the expected expenditures for which 
an APM Entity is responsible under the payment arrangement.
* * * * *
    (7) Capitation. A full capitation arrangement meets this Other 
Payer Advanced APM criterion. For purposes of paragraph (d)(3) of this 
section, a full capitation arrangement means a payment arrangement in 
which a per capita or otherwise predetermined payment is made under the 
payment arrangement for all items and services furnished to a 
population of beneficiaries during a fixed period of time, and no 
settlement is performed for the purpose of reconciling or sharing 
losses incurred or savings earned by the participant. Arrangements made 
directly between CMS and Medicare Advantage Organizations under the 
Medicare Advantage program (42 U.S.C. 422) are not considered 
capitation arrangements for purposes of this paragraph (c)(7).
* * * * *
0
41. Section 414.1440 is amended by revising paragraphs (d)(1) through 
(3) to read as follows:


Sec.  414.1440  Qualifying APM participant determination: All-payer 
combination option.

* * * * *
    (d) * * *
    (1) CMS performs QP determinations following the QP Performance 
Period using payment amount and/or patient count information submitted 
from January 1 through each of the respective QP determination dates: 
March 31, June 30, and August 31. CMS will use data for the same time 
periods for the Medicare and other payer portions of Threshold Score 
calculations under the All-Payer Combination Option. CMS will use the 
payment amount or patient count method, applying the more advantageous 
of the two for both the Medicare and other payer portions of the 
Threshold score calculation, regardless of the method used for the 
Medicare Threshold Score calculation.

[[Page 36090]]

    (2) An APM Entity may request that CMS make QP determinations at 
the APM Entity level, an eligible clinician may request that CMS make 
QP determinations at the eligible clinician level, and an eligible 
clinician or an APM Entity may request that CMS makes QP determinations 
at the TIN-level in instances where all clinicians who reassigned 
billing rights to the TIN are participating in a single APM Entity. CMS 
makes QP determinations at either the APM Entity, eligible clinician, 
or TIN level. Eligible clinicians assessed at the eligible clinician 
level under the Medicare Option at Sec.  414.1425(b)(2) will be 
assessed at the eligible clinician level only under the All-Payer 
Combination Option. Eligible Clinicians may meet the Medicare and the 
All-Payer Combination Option thresholds using the payment amount method 
for both thresholds, the patient account method for both thresholds, or 
the payment amount method for one threshold and the patient account 
method for the other threshold.
    (3) CMS uses data at the same level for the Medicare and other 
payer portions of Threshold Score calculations under the All-Payer 
Combination Option. When QP determinations are made at the eligible 
clinician or, at the TIN level when all clinicians who have reassigned 
billing rights to the TIN are included in a single APM Entity; and if 
the Medicare Threshold score for the APM Entity group is higher than 
when calculated for the eligible clinician or TIN, CMS makes QP 
determinations using a weighted Medicare Threshold Score that is 
factored into an All-Payer Combination Option Threshold Score.
* * * * *
0
42. Section 414.1445 is amended by revising paragraph (b)(1) and adding 
paragraphs (c)(2)(i) and (ii) to read as follows:


Sec.  414.1445  Determination of other payer advanced APMs.

* * * * *
    (b) * * *
    (1) Payer initiated Other Payer Advanced APM determination process. 
Beginning in 2018, and each year thereafter, at a time determined by 
CMS a payer with a Medicare Health Plan payment arrangement may 
request, in a form and manner specified by CMS, that CMS determine 
whether a Medicare Health Plan payment arrangement meets the Other 
Payer Advanced APM criteria set forth in Sec.  414.1420. A payer with a 
Medicare Health Plan payment arrangement must submit its requests by 
the annual Medicare Advantage bid deadline of the year prior to the 
relevant QP Performance Period.
* * * * *
    (c) * * *
    (2) * * *
    (i) Based on the submission by an eligible clinician or payer of 
evidence that CMS determines sufficiently demonstrates that CEHRT is 
used as specified in Sec.  414.1420(b) by participants in the payment 
arrangement, CMS will consider the CEHRT criterion in Sec.  414.1420(b) 
is satisfied for that payment arrangement.
    (ii) [Reserved]
* * * * *

PART 415--SERVICES FURNISHED BY PHYSICIANS IN PROVIDERS, 
SUPERVISING PHYSICIANS IN TEACHING SETTINGS, AND RESIDENTS IN 
CERTAIN SETTINGS

0
43. The authority citation for part 415 continues to read as follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).

0
44. Section 415.172 is amended by revising paragraph (b) to read as 
follows:


Sec.  415.172  Physician fee schedule payment for services of teaching 
physicians.

* * * * *
    (b) Documentation. Except for services furnished as set forth in 
Sec. Sec.  415.174 (concerning an exception for services furnished in 
hospital outpatient and certain other ambulatory settings), 415.176 
(concerning renal dialysis services), and 415.184 (concerning 
psychiatric services), the medical records must document the teaching 
physician was present at the time the service is furnished. The 
presence of the teaching physician during procedures and evaluation and 
management services may be demonstrated by the notes in the medical 
records made by a physician, resident, or nurse.
* * * * *
0
45. Section 415.174 is amended--
0
a. In paragraph (a)(3)(iii) by adding ``and'' at the end of the 
paragraph;
0
b. In paragraph (a)(3)(iv) by removing ``; and'' and adding a period in 
its place;
0
c. By removing paragraph (a)(3)(v); and
0
d. By adding paragraph (a)(6).
    The addition reads as follows:


Sec.  415.174  Exception: Evaluation and management services furnished 
in certain centers.

    (a) * * *
    (6) The medical records must document the extent of the teaching 
physician's participation in the review and direction of services 
furnished to each beneficiary. The extent of the teaching physician's 
participation may be demonstrated by the notes in the medical records 
made by a physician, resident, or nurse.
* * * * *

PART 495--STANDARDS FOR THE ELECTRONIC HEALTH RECORD TECHNOLOGY 
INCENTIVE PROGRAM

0
46. The authority citation for part 495 continues to read as follows:

    Authority:  Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).

0
47. Section 495.4 is amended in the definition of ``EHR reporting 
period'' by adding reserved paragraph (1)(iv) and adding paragraph 
(1)(v) to read as follows:


Sec.  495.4  Definitions.

* * * * *
    EHR reporting period. * * *
    (1) * * *
    (iv) [Reserved]
    (v) Under the Medicaid Promoting Interoperability Program, for the 
CY 2021 payment year:
    (A) For the EP first demonstrating he or she is a meaningful EHR 
user, any continuous 90-day period within CY 2021 that ends before 
October 31, 2021, or that ends before an earlier date in CY 2021 that 
is specified by the state and approved by CMS in the State Medicaid HIT 
plan described at Sec.  495.332.
    (B) For the EP who has successfully demonstrated he or she is a 
meaningful EHR user in any prior year, any continuous 90-day period 
within CY 2021 that ends before October 31, 2021, or that ends before 
an earlier date in CY 2021 that is specified by the state and approved 
by CMS in the State Medicaid HIT plan described at Sec.  495.332.
* * * * *
0
48. Section 495.24 is amended by revising paragraphs (d)(6)(i)(B) and 
(d)(8)(i)(B)(2), to read as follows:


Sec.  495.24  Stage 3 meaningful use objectives and measures for EPs, 
eligible hospitals and CAHs for 2019 and subsequent years.

* * * * *
    (d) * * *
    (6) * * *
    (i) * * *
    (B) Measures. In accordance with paragraph (a)(2) of this section, 
an EP must satisfy 2 out of the 3 following measures in paragraphs 
(d)(6)(i)(B)(1) through (3) of this section except those measures for 
which an EP qualifies for an exclusion under paragraph (a)(3) of this 
section.
    (1) During the EHR reporting period, more than 5 percent of all 
unique

[[Page 36091]]

patients (or their authorized representatives) seen by the EP actively 
engage with the electronic health record made accessible by the 
provider and do either of the following:
    (i) View, download or transmit to a third party their health 
information;
    (ii) Access their health information through the use of an API that 
can be used by applications chosen by the patient and configured to the 
API in the provider's CEHRT; or
    (iii) A combination of paragraphs (d)(6)(i)(B)(1)(i) and (ii) of 
this section.
    (2) A secure message was sent using the electronic messaging 
function of CEHRT to the patient (or their authorized representatives), 
or in response to a secure message sent by the patient, for more than 5 
percent of all unique patients seen by the EP during the EHR reporting 
period.
    (3) Patient generated health data or data from a nonclinical 
setting is incorporated into the CEHRT for more than 5 percent of all 
unique patients seen by the EP during the EHR reporting period.
* * * * *
    (8) * * *
    (i) * * *
    (B) * * *
    (2) Syndromic surveillance reporting. The EP is in active 
engagement with a public health agency to submit syndromic surveillance 
data from an urgent care setting, or from any other setting from which 
ambulatory syndromic surveillance data are collected by the state or a 
local public health agency.
* * * * *
0
49. Section 495.332 is amended by adding paragraphs (f)(3), (4), and 
(5) to read as follows:


Sec.  495.332  State Medicaid health information technology (HIT) plan 
requirements.

* * * * *
    (f) * * *
    (3) An alternative date within CY 2021 by which all ``EHR reporting 
periods'' (as defined under Sec.  495.4) for the CY 2021 payment year 
for Medicaid EPs demonstrating they are meaningful EHR users must end. 
The alternative date selected by the state must be earlier than October 
31, 2021, and must not be any earlier than the day prior to the 
attestation deadline for Medicaid EPs attesting to that state.
    (4) An alternative date within CY 2021 by which all clinical 
quality measure reporting periods for the CY 2021 payment year for 
Medicaid EPs demonstrating they are meaningful EHR users must end. The 
alternative date selected by the state must be earlier than October 31, 
2021, and must not be any earlier than the day prior to the attestation 
deadline for Medicaid EPs attesting to that state.
    (5) For the CY 2019 payment year and beyond, a state-specific 
listing of which clinical quality measures selected by CMS are 
considered to be high priority measures for purposes of Medicaid EP 
clinical quality measure reporting.
* * * * *

    Dated: June 22, 2018.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
    Dated: June 28, 2018.
Alex M. Azar II,
Secretary, Department of Health and Human Services.

    Note:  The following appendices will not appear in the Code of 
Federal Regulations.

BILLING CODE 4120-01-P

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[FR Doc. 2018-14985 Filed 7-12-18; 4:15 pm]
BILLING CODE 4120-01-C